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59
HACCP STUDY BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 / 09 / 2010 Page 1 of 59 Rev : 0 CONTROLLED DOCUMENT

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Page 1: BLANK HACCP STUDY

HACCP STUDY

REVISION 0

SEPTEMBER 2010

DOC NO MASTER MANUAL

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 1 of 45 Rev 0

CONTROLLED

I N D E X O F C O N T E N TI N D E X O F C O N T E N T P gP g

HACCP STUDY - AMENDMENT RECORD SHEET 3

KEY TERMS 4-6

HACCP OVERVIEW 7

SPECIALIZED PROCESSES amp PROCEDURES 8-9REQUIRING A HACCP PLAN

~ A HACCP STUDY - PROCESS FLOW DIAGRAM ~ 9

Task 1 ASSEMBLY OF OUR HACCP TEAM 10-12

Task 2 DESCRIPTION OF OUR SERVICES 13

Task 3 IDENTIFYING THE INTENDED USE OF OUR SERVICES 14

Task 4 CONSTRUCT OF A SERVICE FLOW DIAGRAM 15-17

Task 5 ON-SITE CONFORMATION OF THE FLOW DIAGRAM 18

Task 6 LISTING OF OUR FOOD SAFETY HAZARDS AND MEASURESTO CONTROL THE HAZARD 19-26

(Principle 1)

Task 7 DETERMINING CRITICAL CONTROL POINT (CCPS) 26-27(DECISION TREE)

(Principle 2)

Task 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP 28(Principle 3)

Task 9 EST A MONITORING SYSTEM FOR EACH CCP 28-29(Principle 4)

Task 10 ESTABLISHING CORRECTIVE ACTION PLANS 30(Principle 5)

Task 11 EST VALIDATION VERIFICATION amp REVIEW 30-43PROCEDURES(Principle 6)

Task 12 EST RECORD KEEPING amp DOCUMENTATION 43-44(Principle 7)

ldquo A complete HACCP system is the result of implementing the HACCP principles in an operation that has a solid foundation of comprehensive prerequisite programs in place A HACCP system includes the HACCP plan and all prerequisite programs rdquo

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 2 of 45 Rev 0

HACCP MANUAL - AMENDMENT RECORD SHEET

This MASTER HACCP STUDY is approved and issued by the BLANK MANAGING DIRECTOR ALL amendments to this Manual shall be approved by the BLANK MD prior to issue

This original (MASTER) will be held in the office of the BLANK MD When a change to this MASTER HACCP Study is incorporated the details below are required to be completed

A new CONTROLLED Version ( or the changed lsquo pages thereof rsquo shall then be retained by the BLANK MD ndash nb the lsquooldrsquo versions isare required to be filed within the BLANK CONTROLLED DOCUMENTS ndash REVISION FILE

Authorised by

Brief Description of amendments

Revision No

Signature of Authorisation

Date

COPYRIGHT THIS HACCP STUDY IS THE PROPERTY OF BLANK AND MAY NOT - IN ANY FORM WHATSOEVER - BE REPRODUCED COPIED OR TRANSMITTED WITHOUT PRIOR WRITTEN PERMISSION FROM THE BLANK MANAGING DIRECTOR

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 3 of 45 Rev 0

Key Terms

~ aw

A measure of the free moisture in a food is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature

~ Control Point

Any point in a specific food system at which loss of control does not lead to an unacceptable health risk

~ Critical Control Point

A point or procedure in a specific food system where loss of control may result in an unacceptable health risk

~ Critical Limit

The maximum or minimum value to which a physical biological or chemical parameter must be controlled at a critical control point to minimize risk that the identified food safety hazard may occur

~ Deviation

Failure to meet a required critical limit for a critical control point

~ Good Retail Practices (GRPs)

Preventive measures that include practices and procedures to effectively control the introduction of pathogens chemicals and physical objects into food that are prerequisites to instituting a HACCP or Risk Control Plan and are not addressed by the Food Code interventions or risk factors

~ HACCP

An acronym for Hazard Analysis Critical Control Point

~ Hazard Analysis Critical Control Point (HACCP)

A prevention-based food safety system that identifies and monitors specific food safety hazards that can adversely affect the safety of food products

~ HACCP Plan

A written document that delineates the formal procedures for following the Hazard Analysis Critical Control Point principles developed by the National Advisory Committee for the Microbiological Criteria for Foods

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 4 of 45 Rev 0

~ HACCP System

The result of implementing the HACCP principles in an operation that has foundational comprehensive prerequisite programs in place A HACCP system includes the HACCP plan and all prerequisite programs

~ Hazard

A biological chemical or physical property that may cause an unacceptable consumer health risk

~ Hazard Analysis

The process of collecting and evaluating information about hazards associated with the food under consideration to decide which are significant and must be addressed in the HACCP plan

~ Monitoring

A planned sequence of observations or measurements of critical limits designed to produce an accurate record and intended to ensure that the critical limit maintains product safety Continuous monitoring means an interrupted record of data

~ pH

The symbol for the negative logarithm of the hydrogen ion concentration which is a measure of the degree of acidity or alkalinity of a solution

~ Potentially Hazardous Food l

A food that is natural or synthetic and that requires temperature control because it is in a form capable of supporting the rapid and progressive growth of infectious or toxigenic micro organisms the growth and toxin production of Clostridium botulinum or in raw shell eggs the growth of Salmonella

~ Enteritidis

Prerequisites for HACCP

Practices and conditions needed prior to and during the implementation of HACCP and which are essential for food safety as described in Codex Alimentarius Commissionrsquos Principles of Food Hygiene and other Codes of

~ Practice

Preventive MeasureAn action to exclude destroy eliminate or reduce a hazard and prevent recontamination through effective means

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 5 of 45 Rev 0

~ Risk

The likelihood that an adverse health effect will occur within a population as a result of a hazard in a food

~ Risk Factor

One of the factors identified by the Centres for Disease Control and Prevention (CDC) as a contributor to the foodborne outbreaks that have been investigated and confirmed The factors are unsafe sources inadequate cooking improper holding contaminated equipment and poor personal hygiene

~ Severity

The seriousness of the effect(s) of a hazard

~ Standard Operating Procedure (SOP)

A detailed set of instructions steps or procedures that control the operational conditions within a food establishment allowing for environmental conditions that are favourable to the production of safe food These written procedures are often equivalent to prerequisite programs of HACCP The extent to which operators employ various SOPs will determine which critical control points need to be controlled

~ Validation

Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

~ Verification

Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 6 of 45 Rev 0

HACCP Overview

Simply stated Hazard Analysis Critical Control Point (HACCP) is a logical and thorough process control system designed to identify and control hazards HACCP focuses on prevention and control of food safety problems at highly specific (and controllable) points in the process chain Implementing a well-designed HACCP program provides food manufacturers and food handlers a high level of control over product safety

HACCP has been around since the 1960rsquos when the Pillsbury Company introduced it in the production of foods for the space program The application of HACCP is based on sound technical and scientific principles that assure food safety Recently numerous meat and poultry operations have been mandated to utilize HACCP to address concerns with food safety

HACCP plans should be specific for each operation Committed personnel involved in the processing operation should conduct the design and implementation of a HACCP plan

Although many of the larger food establishments and chains have the expertise available to develop and implement HACCP systems some of the smaller establishments may require assistance from university extension programs industry associations consultants and government for development of their plans

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 7 of 45 Rev 0

SPECIALIZED PROCESSES amp PROCEDURES REQUIRING A HACCP PLAN

Use of food additives or adding components such as vinegar as a method of food preservation or to render a food so that it is not potentially hazardous Use of unpasteurized whole shell eggs in highly susceptible population (HSP) operations to prepare food in quantities other than single service portions Reduced oxygen packaging (ROP) with barriers

1 Custom processing animals2 Molluscan shellfish tanks3 Smoking for preservation4 Curing5 Time as a public health control6 Preventing contamination from hands

Processes requiring a variance from the State and a formal HACCP plan

bull Smoking food as a method of preservation but not if smoking only forflavor enhancement (using smoking solely for preservation is rarely if ever done)

bull Curing foods such as hams sausages etc

bull Using food additives or adding components such as vinegar as a methodof food preservation or to render a food so that it is not potentially hazardous)

bull Reduced Oxygen Packaging (where CBot is a concern and only one barrier exists)

bull Using more than one container of shellfish at a time (co-mingling)

bull Serving or offering for sale raw or lightly cooked animal foods in a ready-to- eat form (raw eggs raw marinated fish raw molluscan shell fish steak tartar lightly cooked fish soft cooked eggs undercooked meat other than ldquowhole muscle intact beef) and not wanting to use a consumer advisory

bull Molluscan shellfish display tanks that are used to storedisplay shellfish that are offered for human consumption

bull Brewing alcoholic beverages

bull Preparing serving or transporting food by another method that is determined by the HEALTH DEPARTMENT to require a variance or HACCP plan

Processes requiring a variance from the State but no HACCP plan

bull Custom processing of animals or fish for personal use in a licensed food Establishment

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 8 of 45 Rev 0

bull Any other requests that vary from the rules of the code where it is determined that a variance is sufficient without a HACCP Plan

Processes requiring a formal HACCP plan and not a variance from the State

bull Pooling of eggs in a food establishment that serves a highly susceptiblepopulation (retirement home nursing home hospital day car etc)

bull Reduced oxygen packaging (where Cbot is a concern and more than one barrier exists) Processes requiring only a written procedure andor approval by the Health Department

bull Using time only as a public health control for potentially hazardous food

bull Use of a two compartment sink for some limited processes

~ A HACCP STUDY - PROCESS FLOW DIAGRAM ~

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 9 of 45 Rev 0

Task 1 ASSEMBLY OF OUR HACCP TEAM

821 General

Management shall ensure the establishing of criteria for the selection of team members to assist with the study establishing implementation maintenance and continual improvement of the HACCP system Every team member shall accept in writing his assignment and commitment to the HACCP team

822 The team shall consist of a

a) Team leader

The team leader shall be trained in the requirements as set out in this standard

NOTE The management representative and the team leader may be the same person

b) Team members

The team shall be multi-disciplined and members shall be drawn from each part of the organization likely to be affected for example from production purchasing finance technical engineering quality and distribution The HACCP team shall consist of personnel with specific knowledge of and expertise with regard to the service the food handling process and food safety hazard categories Where appropriate team members with knowledge in the following areas should be considered for inclusion in the team

1) food science

2) microbiology

3) quality control

4) engineering

5) industrial chemistry

6) work studying

7) risk assessment

8) production

9) marketing or sales

10) distribution and

11) food service management

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 10 of 45 Rev 0

823 The HACCP team shall establish documentation defining the scope of the HACCP study and the teamrsquos activities The teamrsquos activities should include establishing the following

a) the rules and guidelines for team meetings

b) the criteria used for decision making processes

c) the methodology to be used by the team to determinehazards and CCPs

d) the methodology for reporting on the status of the HACCP system and

e) the methodology for the establishment for procedural requirements orintegration with other relevant management system procedures

824 Where the necessary skills or knowledge are not available within the food handling organization the service of a consultant may be used on condition that the consultant acts only as an expert advisor to the team

Introduction

There are twelve tasks required to develop a HACCP plan and these are designed to ensure that the seven principles are applied correctly Principle 1 which is to conduct a hazard analysis requires that the first five tasks have all been addressed in a logical and honest manner so that all real hazards associated with the commodity have been identified

Establish a HACCP Team

To fully understand the commodity system and be able to identify all likely hazards and CCPs it is important that the HACCP team is made up of people from a wide range of disciplines The team should include

A team leader to convene the group and to direct the work of the team ensuring that the concept is properly applied This person must be familiar with the technique be a good listener and allow all participants to contribute

A specialist with a detailed knowledge of the commodity system is required This specialist will have a major role in the production of the commodity flow diagrams

Several specialists each with an understanding of particular hazards and associated risks eg a microbiologist a chemist a mycotoxicologist a toxicologist a QC manager a process engineer

People such as packaging specialists raw material buyers distribution staff or production staff farmers brokers who are involved with the process and

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 11 of 45 Rev 0

have working knowledge of it may be brought into the team temporarily in order to provide relevant expertise

The teams progress and results of the analysis should be recorded by a technical secretary

If any changes are made to composition or operational procedures it will be necessary to re-assess the HACCP plan in the light of the changes

The first activity of the HACCP team is to identify the scope of the study For example will the whole commodity system be covered or only selected components This will make the task more manageable and specialists can be added to the team as and when they are required

Our HACCP TEAMie Who

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 12 of 45 Rev 0

Task 2 DESCRIPTION OF OUR SERVICES

A complete description of the service shall be given in terms of type and composition (allergens microbiological chemical and physical properties) relevant legislation handling processing presentation or packaging storage and distribution condition and the shelf life under prescribed conditions

Describe the Product Service

To start a hazard analysis a full description of the product including customer specification should be prepared This should include information relevant to safety eg mycotoxin regulationtarget level composition physicalchemical properties of the raw materials and the final product the amount of water available for microbial growth (aw) the amount of acid or alkali in the product (pH) Also information regarding how the product is to be packaged stored and transported should also be considered together with facts regarding its shelf life and recommended storage temperatures Where appropriate labelling information and an example of the label should be included This information will help the HACCP team to identify real hazards associated with the process

Activity DescriptionFacility Site

Project Coordinator

Activity

Site Manager

Address

Phone

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 13 of 45 Rev 0

SERVICES DESCRIPTIONie What Where amp When

Task 3 IDENTIFYING THE INTENDED USE OF OUR SERVICES

The intended use and possible abuse of the service by consumers consumer groups or customers shall be described Attention shall be focused on the likely uses and abuses of the service after it has left the control of the food handling organization Factors such as the vulnerability of the consumer and instructions for use shall be taken into account

Identify the products Services intended use

How the product is intended to be used is an important consideration Information on whether the product will be consumed directly or be cooked or be further processed will all have a bearing on the hazard analysis see task 6) The nature of the target group for the product may also be relevant particularly if it includes susceptible groups such as infants the elderly and the malnourished The likelihood of misuse of a product should also be considered such as the use of pet food as a human food either by accident or design This information can be recorded on the same form as the product description

INTENDED USE OF OUR SERVICEie Why

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 14 of 45 Rev 0

Stage 4 CONSTRUCTION OF OUR SERVICE FLOW DIAGRAM

851 The HACCP team shall prepare a detailed floe diagram for the specified food services or process categories relevant to the defined scope of the HACCP study

852 The following should be considered when preparing the flow diagram

a) the selection of raw material

b) processing activities

d) processing delays

e) packaging and storage

f) distribution retail and customer handling of the service

g) any outsourced processes and

h) removal of intermediary services by-services and waste

853 A floor plan relevant to the areas falling within the defined scope of the HACCP study shall be prepared The following should be considered during the preparation of the floor plan as relevant technical data for an effective evaluation of the service flow

a) layout and design features of equipment

b) service flow of liquids powders raw and cooked foods

c) routes of personnel and their personal hygiene practices

d) service recycle or rework loops

e) routes of potential cross-contamination through movement of materials

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 15 of 45 Rev 0

(ingredients returns water packaging materials etc)

f) segregation of high risk areas from low risk areas where a risk of cross-contamination exists

g) storage and distribution conditions of the different materials used in thefood handling process

h) packaging materials used and

I) factory hygiene cleaning and disinfection procedures

Draw up the Commodity Flow Diagram ( CFD )

The first function of the team is to draw up a detailed commodity flow diagram (CFD) of the commodity system or that part of it which is relevant The expertise of the commodity specialist is important at this stage Commodity systems will differ in detail in different parts of the world and even within one country there may be a number of variants Secondary processing will need to be detailed for each facility using generic flows only as a guide

BLANK FOOD SERVICES ndash COMMODITY FLOW DIAGRAMie How

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 16 of 45 Rev 0

NOTE For your information only ndash two EXAMPLES of FOOD SERVICESrsquo FLOW DIAGRAMS

1

2

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 17 of 45 Rev 0

Receiving

Cooking CCP

Cutting Preparation

Frozen Storage

Cooking CCP

Refrigerated Storage

Serving

Thawing

Serving

Hot Holding CCP

Cooling CCP

Consumption

Reheating CCP

Consumption

Serving

Slicing

Consumption

Serving

Slicing

Cooling CCP

Serving

Hot Holding CCP

Stage 5 ON-SITE CONFIRMATION OF THE COMMODITY FLOWDIAGRAM

The HACCP team shall confirm the accuracy of the flow diagram and the floor plan on site during all stages and hours of operation so as to ensure that the flow diagram floor plan and technical data as described in 853 gives an accurate representation of the operation The flow diagram shall be amended to take into account any deviation from the original diagram

Records shall be kept

On site confirmation of flow diagram

Upon completion of the CFD members of the team should visit the commodity system (eg farm store or manufacturing area) to compare the information present on the CFD with what actually happens in practice This is known as walking the line a step by step practice to check that all information regarding materials practices controls etc have been taken into consideration by the team during the preparation of the CFD Information such as time of harvest drying procedures storage conditions the marketing chain socio-economic factors grading systems and any incentive for improved quality or safety and processing systems should be collected and included in the CFD as appropriate The site for which the HACCP plan is being designed should be visited as many times as possible to ensure that all relevant information has been collected

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 18 of 45 Rev 0

Stage 6 LISTING OF OUR FOOD SAFETY HAZARDS AND MEASURESTO CONTROL THE HAZARD

(Principle 1)

871 The HACCP team shall use the confirmed flow diagram including all the technical data as a guide to identify all the potential food safety hazards (inherent and introduced) that might reasonably be expected to occur at each step of the food handling process Relevant legislation related to the food safety hazards and their control shall be considered The hazards shall be considered in the light of the significance likelihood and severity of such a hazard in terms of the safety of the consumer

872 Control measures for each identified food safety hazard shall be established in order to control such a hazard More than one hazard and control measure might be applicable to one step in the process and more than one control measure might be necessary to control a particular hazard

873 Records shall be kept

Identify and analyse hazard(s)

Effective hazard identification and hazard analysis are the keys to a successful HACCP Plan All real or potential hazards that may occur in each ingredient and at each stage of the commodity system should be considered Food safety hazards for HACCP programmes have been classified into three types of hazards

Biological typically foodborne bacterial pathogens such as Salmonella Listeria and E coli also viruses algae parasites and fungi

Chemical There are three principle types of chemical toxins found in foods naturally occurring chemicals eg cyanides in some root crops and allergenic compounds in peanuts toxins produced by micro-organisms eg mycotoxins

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 19 of 45 Rev 0

and algal toxins and chemicals added to the commodity by man to control an identified problem eg fungicides or insecticides

Physical contaminants such as broken glass metal fragments insects or stones

The probability that a hazard will occur is called a risk The risk may take a value from zero to one depending on the degree of certainty that the hazard will be absent or that it will be present After hazard identification a hazard analysis must be conducted to understand the relative health risk to man or animal posed by the hazard It is a way of organizing and analyzing the available scientific information on the nature and size of the health risk associated with the hazard The risk may have to be assessed subjectively and simply classified as low medium or high Only those hazards considered by the HACCP team to present an unacceptable risk of being present are taken forward to Stage 7 Principle 2

Once a food safety hazard has been identified then appropriate control measures should be considered These are any action or activity that can be used to control the identified hazard such that it is prevented eliminated or reduced to an acceptable level The control measure may also include training of personnel for a particular operation covered by Good Manufacturing Processes ( GMP)

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

To identify all biological chemical physical and allergen hazards associated with the purchasing delivering storing usage and sale of BLANKrsquos services

Biological Hazards

The following biological hazards were covered by the terms of reference of our HACCP study

1 Yeast amp Moulds2 Coliforms3 E coli4 Listeria5 Salmonella6 Enterobacteriaceae7 Aerobic Mesophile8 Salmonella spp

Chemical Hazards

The following chemical hazards were covered by the terms of reference of our HACCP study

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 20 of 45 Rev 0

1 Cleaning residues2 Printing inks lacquers from packaging3 Chemical contaminants and residues in raw materials

Physical Hazards

The following physical hazards were covered by the terms of reference of our HACCP study

1 Metal2 Glass3 Hair4 Wooden splinters5 Dust dirt particles6 Plastic7 Insects

Allergen Hazards

All the following common allergens were considered as part of our HACCP study

1 Milk2 Egg3 Nuts4 Soya5 Gluten6 Crustaceans7 Fish8 Peanuts9 Celery10 Mustard11 Sesame Seeds12 Sulphites13 Lupin14 Molluscs and products thereof

CHEMICALS USED IN FOOD PROCESSINGPoint of use Type of chemicalGrowing crops Pesticides herbicides defoliants Raising livestock Growth hormones antibiotics Production Food additives processing aids Plant maintenance

Lubricants paints solvents

Plant sanitation Cleaners sanitizing agents pesticides

SOME FOOD-BORNE BIOLOGICAL HAZARDS

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 21 of 45 Rev 0

Bacteria Parasites Seafood toxinsAeromonas hydrophila

Anisakis spp Ciguatera fish poisoning

Bacillus cereus Ascaris lumbricoides Gempylotoxin Brucella spp Cyclospora

cayetanensisTetrodotoxin

Campylobacter jejuni

Cryptosporidium parvum

Scombrotoxin ( histamine )

Clostridium botulinum

Diphyllobothrium spp Paralytic neurotoxic and

Clostridium perfringens

Entamoeba histolytica Diarrhetic shellfish poisoning

Listeria monocytogenes

Giardia lamblia

Pathogenic Escherichia coli

Taenia spp

Plesiomonas shigelloides

Viruses

Salmonella spp Hepatitis A virusShigella spp Mycotoxigenic moulds PoliovirusesStaphylococcus aureus

Aspergillus spp Norwalk virus group

Streptococcus pyogenes

Fusarium spp

Vibrio cholera Penicillium sppV parahaemolyticusV vulnificusYersinia enterocolitica

EXAMPLES OF PHYSICAL HAZARDS amp THEIR SOURCESPhysical hazard

Source

Metal Bolts nuts screws screens sieves steel woolGlass Light bulbs watch crystals thermometers etcWood splinters Pallets equipment bracing overhead structureInsects Environment electrocution traps incoming ingredients Hair Meat ingredients employees clothing rodentsMould Poor sanitation inadequate cleaning of equipmentRodents droppings

Inadequate rodent controls incoming ingredients

Dirt rocks Raw materials poor employee practices Paint flakes Equipment overhead structureBand-aid Poor employee practicesPen caps Poor employee practicesCarcass ID tags Slaughterhouse

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 22 of 45 Rev 0

Hypodermic needles

Veterinarian

Bullets shot BBs

Animals shot while in fields

Feathers Poor sanitation inadequate pest ( bird ) controls Gasket material Inadequate preventive maintenance of equipment Grease Poor equipment maintenance programme

NB Please refer to the generic Hazard Analysis Questionnaire ( under CHECKLISTS ) ndash this checklist is for PER PRODUCT USED

INFO can also be obtained from the productsrsquo MSDS ( MATERIAL SAFETY DATASHEET ) AND OR The Productsrsquo Ingredients Listing

EXAMPLE 1 OF HACCP DECISION TREE

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 23 of 45 Rev 0

Q1 Does this step involve a hazard of sufficient likelihood of occurrence and severity to warrant its control

Q3 Is control at this step necessary to prevent eliminate or reduce the risk of hazard to consumers

Modify step process or product

Yes

Is control at this step necessary for safety

Q2 Does a control measure for the hazard exist at this step

Yes

Yes

Yes

No

No

No

No

Not a CCP

This is a critical control point

Not a CCP

Not a CCP

EXAMPLE 2 OF HACCP DECISION TREE

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 24 of 45 Rev 0

Q2 Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level

No

Yes

Q1 Do control measure(s) exist for the identified hazard

Modify step process or product

Q4 Will a subsequent step prior to consuming the food eliminate the identified hazard(s) or reduce the likely occurrence to an acceptable level

Q3 Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable level(s)

Yes

Yes

Yes

Yes

No

No

No

Is control at this step necessary for safety

Not a CCP

Not a CCP

This is a critical control point

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

Biological Hazards123456789101112131415

Chemical Hazards123456789101112131415

Physical Hazards12

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 25 of 45 Rev 0

3

456789101112131415

Allergen Hazards123456789101112131415

Stage 7 DETERMINING CRITICAL CONTROL POINT (CCPS) (DECISION TREE)

(Principle 2)

The HACCP team shall determine whether a particular step in the food handling process is a CCP

The method by which a CCP is determined shall be recorder

NOTE The decision tree in annex B can be as a guideline

INTRODUCTION

A Critical Control Point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level

If a hazard has been identified at a step where control is necessary for safety and no control measure exists at that step or any other then the product or process should be modified at that step or at any earlier or later stage to include a control measure

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 26 of 45 Rev 0

Determine the Critical Control Points (CCPs)

Each step in the commodity flow diagram within the scope of the HACCP study should be taken in turn and the relevance of each identified hazard should be considered It is also important to remember the stated scope of the HACCP analysis at this stage The team must determine whether the hazard can occur at this step and if so whether control measures exist If the hazard can be controlled adequately and is not best controlled at another step and is essential for food safety then this step is a CCP for the specified hazard A decision tree can be used to determine CCPs However the HACCP teams judgement expertise and knowledge of the process are the major factors in establishing CCPs

If a step is identified where a food safety hazard exists but no adequate control measures can be put in place either at this step or subsequently then the product is unsafe for human consumption Production should cease until control measures are available and a CCP can be introduced

The proper identification of Critical Control Points (CCPs) is crucial to the ultimate effectiveness of a HACCP plan The plan must specify where each identified hazard will be controlled

Hazards that cannot be controlled by the operator must be identified on the HACCP plan The plan must indicate how these hazards will be addressed outside the establishment (ie purchasing pre-frozen fish where the supplier is responsible for the freezing requirements as specified by regulation)

Note The evaluation for completeness of the written CCPs will ensure that all relevant information dealing with critical limits monitoring corrective actions verification procedures and record keeping is specified for each identified hazard

D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S ( C C P S )( C C P S ) (HACCP principle 2)

The determination of a CCP in the HACCP system shall be facilitated using a decision tree ndash as is shown in the following diagram

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 27 of 45 Rev 0

HACCP concept element Application step amp principle

Define the food and the processes involved in production

Break down the process into steps

Determine possible hazards associated with each step and probability of hazard persistence in end product if no affective preventive measures are implemented

Specify control measures

Consequently determine critical control points ( CCPs )

Establish critical limits

Monitor CCPs to ensure proper implementation of control measures

Take corrective action when parameter monitoring indicates failure of control measure

HACCP principles 4 and 5

Application steps 9-10

HACCP principles 2 and 3

Application steps 7-8

HACCP principle 1

Application step 6

Application steps 1-5

System to be reviewed confirmed and audited

Records must be generated for the system to be documented

HACCP principles 6 and 7

Application steps 11-12

Stage 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP (Principle 3)

The HACCP team shall establish specific and measurable critical limits appropriate for each CCP Critical limits that can be measured quickly and easily shall be used Measurements can include sensory examination mass measurements temperature measurements time moisture level PH value and chemical analysis

Records shall be kept

Establish critical limits for each CCP

Critical limits must be specified and validated for each CCP Criteria often used include measurements of temperature time moisture level pH water activity and sensory parameters such as visual appearance In the case of mycotoxins for example they may include the moisture content or the temperature of the commodity All critical limits and the associated permissible tolerances must be documented in the HACCP Plan Worksheet and included as specifications in operating procedures and work instructions

ie Critical limits have to be established for all critical components associated with each hazard that is controlled by a CCP

Critical Limits must meet or exceed relevant regulatory and program requirements Some establishments set critical limits to exceed regulatory requirements This is acceptable but the establishment should be made aware that if these limits are the ones written into the HACCP plan the inspection will be conducted against these more stringent limits

Critical limits normally include measurements such as temperature time moisture level pH aw available chlorine and sensory attributes When applicable compare the critical limits found the establishment HACCP plan to those considered standard industry practice

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For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

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upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

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8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

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81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

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acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

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Page 2: BLANK HACCP STUDY

I N D E X O F C O N T E N TI N D E X O F C O N T E N T P gP g

HACCP STUDY - AMENDMENT RECORD SHEET 3

KEY TERMS 4-6

HACCP OVERVIEW 7

SPECIALIZED PROCESSES amp PROCEDURES 8-9REQUIRING A HACCP PLAN

~ A HACCP STUDY - PROCESS FLOW DIAGRAM ~ 9

Task 1 ASSEMBLY OF OUR HACCP TEAM 10-12

Task 2 DESCRIPTION OF OUR SERVICES 13

Task 3 IDENTIFYING THE INTENDED USE OF OUR SERVICES 14

Task 4 CONSTRUCT OF A SERVICE FLOW DIAGRAM 15-17

Task 5 ON-SITE CONFORMATION OF THE FLOW DIAGRAM 18

Task 6 LISTING OF OUR FOOD SAFETY HAZARDS AND MEASURESTO CONTROL THE HAZARD 19-26

(Principle 1)

Task 7 DETERMINING CRITICAL CONTROL POINT (CCPS) 26-27(DECISION TREE)

(Principle 2)

Task 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP 28(Principle 3)

Task 9 EST A MONITORING SYSTEM FOR EACH CCP 28-29(Principle 4)

Task 10 ESTABLISHING CORRECTIVE ACTION PLANS 30(Principle 5)

Task 11 EST VALIDATION VERIFICATION amp REVIEW 30-43PROCEDURES(Principle 6)

Task 12 EST RECORD KEEPING amp DOCUMENTATION 43-44(Principle 7)

ldquo A complete HACCP system is the result of implementing the HACCP principles in an operation that has a solid foundation of comprehensive prerequisite programs in place A HACCP system includes the HACCP plan and all prerequisite programs rdquo

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HACCP MANUAL - AMENDMENT RECORD SHEET

This MASTER HACCP STUDY is approved and issued by the BLANK MANAGING DIRECTOR ALL amendments to this Manual shall be approved by the BLANK MD prior to issue

This original (MASTER) will be held in the office of the BLANK MD When a change to this MASTER HACCP Study is incorporated the details below are required to be completed

A new CONTROLLED Version ( or the changed lsquo pages thereof rsquo shall then be retained by the BLANK MD ndash nb the lsquooldrsquo versions isare required to be filed within the BLANK CONTROLLED DOCUMENTS ndash REVISION FILE

Authorised by

Brief Description of amendments

Revision No

Signature of Authorisation

Date

COPYRIGHT THIS HACCP STUDY IS THE PROPERTY OF BLANK AND MAY NOT - IN ANY FORM WHATSOEVER - BE REPRODUCED COPIED OR TRANSMITTED WITHOUT PRIOR WRITTEN PERMISSION FROM THE BLANK MANAGING DIRECTOR

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Key Terms

~ aw

A measure of the free moisture in a food is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature

~ Control Point

Any point in a specific food system at which loss of control does not lead to an unacceptable health risk

~ Critical Control Point

A point or procedure in a specific food system where loss of control may result in an unacceptable health risk

~ Critical Limit

The maximum or minimum value to which a physical biological or chemical parameter must be controlled at a critical control point to minimize risk that the identified food safety hazard may occur

~ Deviation

Failure to meet a required critical limit for a critical control point

~ Good Retail Practices (GRPs)

Preventive measures that include practices and procedures to effectively control the introduction of pathogens chemicals and physical objects into food that are prerequisites to instituting a HACCP or Risk Control Plan and are not addressed by the Food Code interventions or risk factors

~ HACCP

An acronym for Hazard Analysis Critical Control Point

~ Hazard Analysis Critical Control Point (HACCP)

A prevention-based food safety system that identifies and monitors specific food safety hazards that can adversely affect the safety of food products

~ HACCP Plan

A written document that delineates the formal procedures for following the Hazard Analysis Critical Control Point principles developed by the National Advisory Committee for the Microbiological Criteria for Foods

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~ HACCP System

The result of implementing the HACCP principles in an operation that has foundational comprehensive prerequisite programs in place A HACCP system includes the HACCP plan and all prerequisite programs

~ Hazard

A biological chemical or physical property that may cause an unacceptable consumer health risk

~ Hazard Analysis

The process of collecting and evaluating information about hazards associated with the food under consideration to decide which are significant and must be addressed in the HACCP plan

~ Monitoring

A planned sequence of observations or measurements of critical limits designed to produce an accurate record and intended to ensure that the critical limit maintains product safety Continuous monitoring means an interrupted record of data

~ pH

The symbol for the negative logarithm of the hydrogen ion concentration which is a measure of the degree of acidity or alkalinity of a solution

~ Potentially Hazardous Food l

A food that is natural or synthetic and that requires temperature control because it is in a form capable of supporting the rapid and progressive growth of infectious or toxigenic micro organisms the growth and toxin production of Clostridium botulinum or in raw shell eggs the growth of Salmonella

~ Enteritidis

Prerequisites for HACCP

Practices and conditions needed prior to and during the implementation of HACCP and which are essential for food safety as described in Codex Alimentarius Commissionrsquos Principles of Food Hygiene and other Codes of

~ Practice

Preventive MeasureAn action to exclude destroy eliminate or reduce a hazard and prevent recontamination through effective means

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~ Risk

The likelihood that an adverse health effect will occur within a population as a result of a hazard in a food

~ Risk Factor

One of the factors identified by the Centres for Disease Control and Prevention (CDC) as a contributor to the foodborne outbreaks that have been investigated and confirmed The factors are unsafe sources inadequate cooking improper holding contaminated equipment and poor personal hygiene

~ Severity

The seriousness of the effect(s) of a hazard

~ Standard Operating Procedure (SOP)

A detailed set of instructions steps or procedures that control the operational conditions within a food establishment allowing for environmental conditions that are favourable to the production of safe food These written procedures are often equivalent to prerequisite programs of HACCP The extent to which operators employ various SOPs will determine which critical control points need to be controlled

~ Validation

Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

~ Verification

Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

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HACCP Overview

Simply stated Hazard Analysis Critical Control Point (HACCP) is a logical and thorough process control system designed to identify and control hazards HACCP focuses on prevention and control of food safety problems at highly specific (and controllable) points in the process chain Implementing a well-designed HACCP program provides food manufacturers and food handlers a high level of control over product safety

HACCP has been around since the 1960rsquos when the Pillsbury Company introduced it in the production of foods for the space program The application of HACCP is based on sound technical and scientific principles that assure food safety Recently numerous meat and poultry operations have been mandated to utilize HACCP to address concerns with food safety

HACCP plans should be specific for each operation Committed personnel involved in the processing operation should conduct the design and implementation of a HACCP plan

Although many of the larger food establishments and chains have the expertise available to develop and implement HACCP systems some of the smaller establishments may require assistance from university extension programs industry associations consultants and government for development of their plans

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SPECIALIZED PROCESSES amp PROCEDURES REQUIRING A HACCP PLAN

Use of food additives or adding components such as vinegar as a method of food preservation or to render a food so that it is not potentially hazardous Use of unpasteurized whole shell eggs in highly susceptible population (HSP) operations to prepare food in quantities other than single service portions Reduced oxygen packaging (ROP) with barriers

1 Custom processing animals2 Molluscan shellfish tanks3 Smoking for preservation4 Curing5 Time as a public health control6 Preventing contamination from hands

Processes requiring a variance from the State and a formal HACCP plan

bull Smoking food as a method of preservation but not if smoking only forflavor enhancement (using smoking solely for preservation is rarely if ever done)

bull Curing foods such as hams sausages etc

bull Using food additives or adding components such as vinegar as a methodof food preservation or to render a food so that it is not potentially hazardous)

bull Reduced Oxygen Packaging (where CBot is a concern and only one barrier exists)

bull Using more than one container of shellfish at a time (co-mingling)

bull Serving or offering for sale raw or lightly cooked animal foods in a ready-to- eat form (raw eggs raw marinated fish raw molluscan shell fish steak tartar lightly cooked fish soft cooked eggs undercooked meat other than ldquowhole muscle intact beef) and not wanting to use a consumer advisory

bull Molluscan shellfish display tanks that are used to storedisplay shellfish that are offered for human consumption

bull Brewing alcoholic beverages

bull Preparing serving or transporting food by another method that is determined by the HEALTH DEPARTMENT to require a variance or HACCP plan

Processes requiring a variance from the State but no HACCP plan

bull Custom processing of animals or fish for personal use in a licensed food Establishment

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bull Any other requests that vary from the rules of the code where it is determined that a variance is sufficient without a HACCP Plan

Processes requiring a formal HACCP plan and not a variance from the State

bull Pooling of eggs in a food establishment that serves a highly susceptiblepopulation (retirement home nursing home hospital day car etc)

bull Reduced oxygen packaging (where Cbot is a concern and more than one barrier exists) Processes requiring only a written procedure andor approval by the Health Department

bull Using time only as a public health control for potentially hazardous food

bull Use of a two compartment sink for some limited processes

~ A HACCP STUDY - PROCESS FLOW DIAGRAM ~

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Task 1 ASSEMBLY OF OUR HACCP TEAM

821 General

Management shall ensure the establishing of criteria for the selection of team members to assist with the study establishing implementation maintenance and continual improvement of the HACCP system Every team member shall accept in writing his assignment and commitment to the HACCP team

822 The team shall consist of a

a) Team leader

The team leader shall be trained in the requirements as set out in this standard

NOTE The management representative and the team leader may be the same person

b) Team members

The team shall be multi-disciplined and members shall be drawn from each part of the organization likely to be affected for example from production purchasing finance technical engineering quality and distribution The HACCP team shall consist of personnel with specific knowledge of and expertise with regard to the service the food handling process and food safety hazard categories Where appropriate team members with knowledge in the following areas should be considered for inclusion in the team

1) food science

2) microbiology

3) quality control

4) engineering

5) industrial chemistry

6) work studying

7) risk assessment

8) production

9) marketing or sales

10) distribution and

11) food service management

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823 The HACCP team shall establish documentation defining the scope of the HACCP study and the teamrsquos activities The teamrsquos activities should include establishing the following

a) the rules and guidelines for team meetings

b) the criteria used for decision making processes

c) the methodology to be used by the team to determinehazards and CCPs

d) the methodology for reporting on the status of the HACCP system and

e) the methodology for the establishment for procedural requirements orintegration with other relevant management system procedures

824 Where the necessary skills or knowledge are not available within the food handling organization the service of a consultant may be used on condition that the consultant acts only as an expert advisor to the team

Introduction

There are twelve tasks required to develop a HACCP plan and these are designed to ensure that the seven principles are applied correctly Principle 1 which is to conduct a hazard analysis requires that the first five tasks have all been addressed in a logical and honest manner so that all real hazards associated with the commodity have been identified

Establish a HACCP Team

To fully understand the commodity system and be able to identify all likely hazards and CCPs it is important that the HACCP team is made up of people from a wide range of disciplines The team should include

A team leader to convene the group and to direct the work of the team ensuring that the concept is properly applied This person must be familiar with the technique be a good listener and allow all participants to contribute

A specialist with a detailed knowledge of the commodity system is required This specialist will have a major role in the production of the commodity flow diagrams

Several specialists each with an understanding of particular hazards and associated risks eg a microbiologist a chemist a mycotoxicologist a toxicologist a QC manager a process engineer

People such as packaging specialists raw material buyers distribution staff or production staff farmers brokers who are involved with the process and

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have working knowledge of it may be brought into the team temporarily in order to provide relevant expertise

The teams progress and results of the analysis should be recorded by a technical secretary

If any changes are made to composition or operational procedures it will be necessary to re-assess the HACCP plan in the light of the changes

The first activity of the HACCP team is to identify the scope of the study For example will the whole commodity system be covered or only selected components This will make the task more manageable and specialists can be added to the team as and when they are required

Our HACCP TEAMie Who

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Task 2 DESCRIPTION OF OUR SERVICES

A complete description of the service shall be given in terms of type and composition (allergens microbiological chemical and physical properties) relevant legislation handling processing presentation or packaging storage and distribution condition and the shelf life under prescribed conditions

Describe the Product Service

To start a hazard analysis a full description of the product including customer specification should be prepared This should include information relevant to safety eg mycotoxin regulationtarget level composition physicalchemical properties of the raw materials and the final product the amount of water available for microbial growth (aw) the amount of acid or alkali in the product (pH) Also information regarding how the product is to be packaged stored and transported should also be considered together with facts regarding its shelf life and recommended storage temperatures Where appropriate labelling information and an example of the label should be included This information will help the HACCP team to identify real hazards associated with the process

Activity DescriptionFacility Site

Project Coordinator

Activity

Site Manager

Address

Phone

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SERVICES DESCRIPTIONie What Where amp When

Task 3 IDENTIFYING THE INTENDED USE OF OUR SERVICES

The intended use and possible abuse of the service by consumers consumer groups or customers shall be described Attention shall be focused on the likely uses and abuses of the service after it has left the control of the food handling organization Factors such as the vulnerability of the consumer and instructions for use shall be taken into account

Identify the products Services intended use

How the product is intended to be used is an important consideration Information on whether the product will be consumed directly or be cooked or be further processed will all have a bearing on the hazard analysis see task 6) The nature of the target group for the product may also be relevant particularly if it includes susceptible groups such as infants the elderly and the malnourished The likelihood of misuse of a product should also be considered such as the use of pet food as a human food either by accident or design This information can be recorded on the same form as the product description

INTENDED USE OF OUR SERVICEie Why

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Stage 4 CONSTRUCTION OF OUR SERVICE FLOW DIAGRAM

851 The HACCP team shall prepare a detailed floe diagram for the specified food services or process categories relevant to the defined scope of the HACCP study

852 The following should be considered when preparing the flow diagram

a) the selection of raw material

b) processing activities

d) processing delays

e) packaging and storage

f) distribution retail and customer handling of the service

g) any outsourced processes and

h) removal of intermediary services by-services and waste

853 A floor plan relevant to the areas falling within the defined scope of the HACCP study shall be prepared The following should be considered during the preparation of the floor plan as relevant technical data for an effective evaluation of the service flow

a) layout and design features of equipment

b) service flow of liquids powders raw and cooked foods

c) routes of personnel and their personal hygiene practices

d) service recycle or rework loops

e) routes of potential cross-contamination through movement of materials

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(ingredients returns water packaging materials etc)

f) segregation of high risk areas from low risk areas where a risk of cross-contamination exists

g) storage and distribution conditions of the different materials used in thefood handling process

h) packaging materials used and

I) factory hygiene cleaning and disinfection procedures

Draw up the Commodity Flow Diagram ( CFD )

The first function of the team is to draw up a detailed commodity flow diagram (CFD) of the commodity system or that part of it which is relevant The expertise of the commodity specialist is important at this stage Commodity systems will differ in detail in different parts of the world and even within one country there may be a number of variants Secondary processing will need to be detailed for each facility using generic flows only as a guide

BLANK FOOD SERVICES ndash COMMODITY FLOW DIAGRAMie How

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NOTE For your information only ndash two EXAMPLES of FOOD SERVICESrsquo FLOW DIAGRAMS

1

2

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Receiving

Cooking CCP

Cutting Preparation

Frozen Storage

Cooking CCP

Refrigerated Storage

Serving

Thawing

Serving

Hot Holding CCP

Cooling CCP

Consumption

Reheating CCP

Consumption

Serving

Slicing

Consumption

Serving

Slicing

Cooling CCP

Serving

Hot Holding CCP

Stage 5 ON-SITE CONFIRMATION OF THE COMMODITY FLOWDIAGRAM

The HACCP team shall confirm the accuracy of the flow diagram and the floor plan on site during all stages and hours of operation so as to ensure that the flow diagram floor plan and technical data as described in 853 gives an accurate representation of the operation The flow diagram shall be amended to take into account any deviation from the original diagram

Records shall be kept

On site confirmation of flow diagram

Upon completion of the CFD members of the team should visit the commodity system (eg farm store or manufacturing area) to compare the information present on the CFD with what actually happens in practice This is known as walking the line a step by step practice to check that all information regarding materials practices controls etc have been taken into consideration by the team during the preparation of the CFD Information such as time of harvest drying procedures storage conditions the marketing chain socio-economic factors grading systems and any incentive for improved quality or safety and processing systems should be collected and included in the CFD as appropriate The site for which the HACCP plan is being designed should be visited as many times as possible to ensure that all relevant information has been collected

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Stage 6 LISTING OF OUR FOOD SAFETY HAZARDS AND MEASURESTO CONTROL THE HAZARD

(Principle 1)

871 The HACCP team shall use the confirmed flow diagram including all the technical data as a guide to identify all the potential food safety hazards (inherent and introduced) that might reasonably be expected to occur at each step of the food handling process Relevant legislation related to the food safety hazards and their control shall be considered The hazards shall be considered in the light of the significance likelihood and severity of such a hazard in terms of the safety of the consumer

872 Control measures for each identified food safety hazard shall be established in order to control such a hazard More than one hazard and control measure might be applicable to one step in the process and more than one control measure might be necessary to control a particular hazard

873 Records shall be kept

Identify and analyse hazard(s)

Effective hazard identification and hazard analysis are the keys to a successful HACCP Plan All real or potential hazards that may occur in each ingredient and at each stage of the commodity system should be considered Food safety hazards for HACCP programmes have been classified into three types of hazards

Biological typically foodborne bacterial pathogens such as Salmonella Listeria and E coli also viruses algae parasites and fungi

Chemical There are three principle types of chemical toxins found in foods naturally occurring chemicals eg cyanides in some root crops and allergenic compounds in peanuts toxins produced by micro-organisms eg mycotoxins

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and algal toxins and chemicals added to the commodity by man to control an identified problem eg fungicides or insecticides

Physical contaminants such as broken glass metal fragments insects or stones

The probability that a hazard will occur is called a risk The risk may take a value from zero to one depending on the degree of certainty that the hazard will be absent or that it will be present After hazard identification a hazard analysis must be conducted to understand the relative health risk to man or animal posed by the hazard It is a way of organizing and analyzing the available scientific information on the nature and size of the health risk associated with the hazard The risk may have to be assessed subjectively and simply classified as low medium or high Only those hazards considered by the HACCP team to present an unacceptable risk of being present are taken forward to Stage 7 Principle 2

Once a food safety hazard has been identified then appropriate control measures should be considered These are any action or activity that can be used to control the identified hazard such that it is prevented eliminated or reduced to an acceptable level The control measure may also include training of personnel for a particular operation covered by Good Manufacturing Processes ( GMP)

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

To identify all biological chemical physical and allergen hazards associated with the purchasing delivering storing usage and sale of BLANKrsquos services

Biological Hazards

The following biological hazards were covered by the terms of reference of our HACCP study

1 Yeast amp Moulds2 Coliforms3 E coli4 Listeria5 Salmonella6 Enterobacteriaceae7 Aerobic Mesophile8 Salmonella spp

Chemical Hazards

The following chemical hazards were covered by the terms of reference of our HACCP study

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1 Cleaning residues2 Printing inks lacquers from packaging3 Chemical contaminants and residues in raw materials

Physical Hazards

The following physical hazards were covered by the terms of reference of our HACCP study

1 Metal2 Glass3 Hair4 Wooden splinters5 Dust dirt particles6 Plastic7 Insects

Allergen Hazards

All the following common allergens were considered as part of our HACCP study

1 Milk2 Egg3 Nuts4 Soya5 Gluten6 Crustaceans7 Fish8 Peanuts9 Celery10 Mustard11 Sesame Seeds12 Sulphites13 Lupin14 Molluscs and products thereof

CHEMICALS USED IN FOOD PROCESSINGPoint of use Type of chemicalGrowing crops Pesticides herbicides defoliants Raising livestock Growth hormones antibiotics Production Food additives processing aids Plant maintenance

Lubricants paints solvents

Plant sanitation Cleaners sanitizing agents pesticides

SOME FOOD-BORNE BIOLOGICAL HAZARDS

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Bacteria Parasites Seafood toxinsAeromonas hydrophila

Anisakis spp Ciguatera fish poisoning

Bacillus cereus Ascaris lumbricoides Gempylotoxin Brucella spp Cyclospora

cayetanensisTetrodotoxin

Campylobacter jejuni

Cryptosporidium parvum

Scombrotoxin ( histamine )

Clostridium botulinum

Diphyllobothrium spp Paralytic neurotoxic and

Clostridium perfringens

Entamoeba histolytica Diarrhetic shellfish poisoning

Listeria monocytogenes

Giardia lamblia

Pathogenic Escherichia coli

Taenia spp

Plesiomonas shigelloides

Viruses

Salmonella spp Hepatitis A virusShigella spp Mycotoxigenic moulds PoliovirusesStaphylococcus aureus

Aspergillus spp Norwalk virus group

Streptococcus pyogenes

Fusarium spp

Vibrio cholera Penicillium sppV parahaemolyticusV vulnificusYersinia enterocolitica

EXAMPLES OF PHYSICAL HAZARDS amp THEIR SOURCESPhysical hazard

Source

Metal Bolts nuts screws screens sieves steel woolGlass Light bulbs watch crystals thermometers etcWood splinters Pallets equipment bracing overhead structureInsects Environment electrocution traps incoming ingredients Hair Meat ingredients employees clothing rodentsMould Poor sanitation inadequate cleaning of equipmentRodents droppings

Inadequate rodent controls incoming ingredients

Dirt rocks Raw materials poor employee practices Paint flakes Equipment overhead structureBand-aid Poor employee practicesPen caps Poor employee practicesCarcass ID tags Slaughterhouse

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Hypodermic needles

Veterinarian

Bullets shot BBs

Animals shot while in fields

Feathers Poor sanitation inadequate pest ( bird ) controls Gasket material Inadequate preventive maintenance of equipment Grease Poor equipment maintenance programme

NB Please refer to the generic Hazard Analysis Questionnaire ( under CHECKLISTS ) ndash this checklist is for PER PRODUCT USED

INFO can also be obtained from the productsrsquo MSDS ( MATERIAL SAFETY DATASHEET ) AND OR The Productsrsquo Ingredients Listing

EXAMPLE 1 OF HACCP DECISION TREE

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Q1 Does this step involve a hazard of sufficient likelihood of occurrence and severity to warrant its control

Q3 Is control at this step necessary to prevent eliminate or reduce the risk of hazard to consumers

Modify step process or product

Yes

Is control at this step necessary for safety

Q2 Does a control measure for the hazard exist at this step

Yes

Yes

Yes

No

No

No

No

Not a CCP

This is a critical control point

Not a CCP

Not a CCP

EXAMPLE 2 OF HACCP DECISION TREE

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Q2 Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level

No

Yes

Q1 Do control measure(s) exist for the identified hazard

Modify step process or product

Q4 Will a subsequent step prior to consuming the food eliminate the identified hazard(s) or reduce the likely occurrence to an acceptable level

Q3 Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable level(s)

Yes

Yes

Yes

Yes

No

No

No

Is control at this step necessary for safety

Not a CCP

Not a CCP

This is a critical control point

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

Biological Hazards123456789101112131415

Chemical Hazards123456789101112131415

Physical Hazards12

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 25 of 45 Rev 0

3

456789101112131415

Allergen Hazards123456789101112131415

Stage 7 DETERMINING CRITICAL CONTROL POINT (CCPS) (DECISION TREE)

(Principle 2)

The HACCP team shall determine whether a particular step in the food handling process is a CCP

The method by which a CCP is determined shall be recorder

NOTE The decision tree in annex B can be as a guideline

INTRODUCTION

A Critical Control Point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level

If a hazard has been identified at a step where control is necessary for safety and no control measure exists at that step or any other then the product or process should be modified at that step or at any earlier or later stage to include a control measure

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 26 of 45 Rev 0

Determine the Critical Control Points (CCPs)

Each step in the commodity flow diagram within the scope of the HACCP study should be taken in turn and the relevance of each identified hazard should be considered It is also important to remember the stated scope of the HACCP analysis at this stage The team must determine whether the hazard can occur at this step and if so whether control measures exist If the hazard can be controlled adequately and is not best controlled at another step and is essential for food safety then this step is a CCP for the specified hazard A decision tree can be used to determine CCPs However the HACCP teams judgement expertise and knowledge of the process are the major factors in establishing CCPs

If a step is identified where a food safety hazard exists but no adequate control measures can be put in place either at this step or subsequently then the product is unsafe for human consumption Production should cease until control measures are available and a CCP can be introduced

The proper identification of Critical Control Points (CCPs) is crucial to the ultimate effectiveness of a HACCP plan The plan must specify where each identified hazard will be controlled

Hazards that cannot be controlled by the operator must be identified on the HACCP plan The plan must indicate how these hazards will be addressed outside the establishment (ie purchasing pre-frozen fish where the supplier is responsible for the freezing requirements as specified by regulation)

Note The evaluation for completeness of the written CCPs will ensure that all relevant information dealing with critical limits monitoring corrective actions verification procedures and record keeping is specified for each identified hazard

D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S ( C C P S )( C C P S ) (HACCP principle 2)

The determination of a CCP in the HACCP system shall be facilitated using a decision tree ndash as is shown in the following diagram

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 27 of 45 Rev 0

HACCP concept element Application step amp principle

Define the food and the processes involved in production

Break down the process into steps

Determine possible hazards associated with each step and probability of hazard persistence in end product if no affective preventive measures are implemented

Specify control measures

Consequently determine critical control points ( CCPs )

Establish critical limits

Monitor CCPs to ensure proper implementation of control measures

Take corrective action when parameter monitoring indicates failure of control measure

HACCP principles 4 and 5

Application steps 9-10

HACCP principles 2 and 3

Application steps 7-8

HACCP principle 1

Application step 6

Application steps 1-5

System to be reviewed confirmed and audited

Records must be generated for the system to be documented

HACCP principles 6 and 7

Application steps 11-12

Stage 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP (Principle 3)

The HACCP team shall establish specific and measurable critical limits appropriate for each CCP Critical limits that can be measured quickly and easily shall be used Measurements can include sensory examination mass measurements temperature measurements time moisture level PH value and chemical analysis

Records shall be kept

Establish critical limits for each CCP

Critical limits must be specified and validated for each CCP Criteria often used include measurements of temperature time moisture level pH water activity and sensory parameters such as visual appearance In the case of mycotoxins for example they may include the moisture content or the temperature of the commodity All critical limits and the associated permissible tolerances must be documented in the HACCP Plan Worksheet and included as specifications in operating procedures and work instructions

ie Critical limits have to be established for all critical components associated with each hazard that is controlled by a CCP

Critical Limits must meet or exceed relevant regulatory and program requirements Some establishments set critical limits to exceed regulatory requirements This is acceptable but the establishment should be made aware that if these limits are the ones written into the HACCP plan the inspection will be conducted against these more stringent limits

Critical limits normally include measurements such as temperature time moisture level pH aw available chlorine and sensory attributes When applicable compare the critical limits found the establishment HACCP plan to those considered standard industry practice

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For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 29 of 45 Rev 0

upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

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8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

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81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

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acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

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Page 3: BLANK HACCP STUDY

HACCP MANUAL - AMENDMENT RECORD SHEET

This MASTER HACCP STUDY is approved and issued by the BLANK MANAGING DIRECTOR ALL amendments to this Manual shall be approved by the BLANK MD prior to issue

This original (MASTER) will be held in the office of the BLANK MD When a change to this MASTER HACCP Study is incorporated the details below are required to be completed

A new CONTROLLED Version ( or the changed lsquo pages thereof rsquo shall then be retained by the BLANK MD ndash nb the lsquooldrsquo versions isare required to be filed within the BLANK CONTROLLED DOCUMENTS ndash REVISION FILE

Authorised by

Brief Description of amendments

Revision No

Signature of Authorisation

Date

COPYRIGHT THIS HACCP STUDY IS THE PROPERTY OF BLANK AND MAY NOT - IN ANY FORM WHATSOEVER - BE REPRODUCED COPIED OR TRANSMITTED WITHOUT PRIOR WRITTEN PERMISSION FROM THE BLANK MANAGING DIRECTOR

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 3 of 45 Rev 0

Key Terms

~ aw

A measure of the free moisture in a food is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature

~ Control Point

Any point in a specific food system at which loss of control does not lead to an unacceptable health risk

~ Critical Control Point

A point or procedure in a specific food system where loss of control may result in an unacceptable health risk

~ Critical Limit

The maximum or minimum value to which a physical biological or chemical parameter must be controlled at a critical control point to minimize risk that the identified food safety hazard may occur

~ Deviation

Failure to meet a required critical limit for a critical control point

~ Good Retail Practices (GRPs)

Preventive measures that include practices and procedures to effectively control the introduction of pathogens chemicals and physical objects into food that are prerequisites to instituting a HACCP or Risk Control Plan and are not addressed by the Food Code interventions or risk factors

~ HACCP

An acronym for Hazard Analysis Critical Control Point

~ Hazard Analysis Critical Control Point (HACCP)

A prevention-based food safety system that identifies and monitors specific food safety hazards that can adversely affect the safety of food products

~ HACCP Plan

A written document that delineates the formal procedures for following the Hazard Analysis Critical Control Point principles developed by the National Advisory Committee for the Microbiological Criteria for Foods

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~ HACCP System

The result of implementing the HACCP principles in an operation that has foundational comprehensive prerequisite programs in place A HACCP system includes the HACCP plan and all prerequisite programs

~ Hazard

A biological chemical or physical property that may cause an unacceptable consumer health risk

~ Hazard Analysis

The process of collecting and evaluating information about hazards associated with the food under consideration to decide which are significant and must be addressed in the HACCP plan

~ Monitoring

A planned sequence of observations or measurements of critical limits designed to produce an accurate record and intended to ensure that the critical limit maintains product safety Continuous monitoring means an interrupted record of data

~ pH

The symbol for the negative logarithm of the hydrogen ion concentration which is a measure of the degree of acidity or alkalinity of a solution

~ Potentially Hazardous Food l

A food that is natural or synthetic and that requires temperature control because it is in a form capable of supporting the rapid and progressive growth of infectious or toxigenic micro organisms the growth and toxin production of Clostridium botulinum or in raw shell eggs the growth of Salmonella

~ Enteritidis

Prerequisites for HACCP

Practices and conditions needed prior to and during the implementation of HACCP and which are essential for food safety as described in Codex Alimentarius Commissionrsquos Principles of Food Hygiene and other Codes of

~ Practice

Preventive MeasureAn action to exclude destroy eliminate or reduce a hazard and prevent recontamination through effective means

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~ Risk

The likelihood that an adverse health effect will occur within a population as a result of a hazard in a food

~ Risk Factor

One of the factors identified by the Centres for Disease Control and Prevention (CDC) as a contributor to the foodborne outbreaks that have been investigated and confirmed The factors are unsafe sources inadequate cooking improper holding contaminated equipment and poor personal hygiene

~ Severity

The seriousness of the effect(s) of a hazard

~ Standard Operating Procedure (SOP)

A detailed set of instructions steps or procedures that control the operational conditions within a food establishment allowing for environmental conditions that are favourable to the production of safe food These written procedures are often equivalent to prerequisite programs of HACCP The extent to which operators employ various SOPs will determine which critical control points need to be controlled

~ Validation

Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

~ Verification

Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

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HACCP Overview

Simply stated Hazard Analysis Critical Control Point (HACCP) is a logical and thorough process control system designed to identify and control hazards HACCP focuses on prevention and control of food safety problems at highly specific (and controllable) points in the process chain Implementing a well-designed HACCP program provides food manufacturers and food handlers a high level of control over product safety

HACCP has been around since the 1960rsquos when the Pillsbury Company introduced it in the production of foods for the space program The application of HACCP is based on sound technical and scientific principles that assure food safety Recently numerous meat and poultry operations have been mandated to utilize HACCP to address concerns with food safety

HACCP plans should be specific for each operation Committed personnel involved in the processing operation should conduct the design and implementation of a HACCP plan

Although many of the larger food establishments and chains have the expertise available to develop and implement HACCP systems some of the smaller establishments may require assistance from university extension programs industry associations consultants and government for development of their plans

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SPECIALIZED PROCESSES amp PROCEDURES REQUIRING A HACCP PLAN

Use of food additives or adding components such as vinegar as a method of food preservation or to render a food so that it is not potentially hazardous Use of unpasteurized whole shell eggs in highly susceptible population (HSP) operations to prepare food in quantities other than single service portions Reduced oxygen packaging (ROP) with barriers

1 Custom processing animals2 Molluscan shellfish tanks3 Smoking for preservation4 Curing5 Time as a public health control6 Preventing contamination from hands

Processes requiring a variance from the State and a formal HACCP plan

bull Smoking food as a method of preservation but not if smoking only forflavor enhancement (using smoking solely for preservation is rarely if ever done)

bull Curing foods such as hams sausages etc

bull Using food additives or adding components such as vinegar as a methodof food preservation or to render a food so that it is not potentially hazardous)

bull Reduced Oxygen Packaging (where CBot is a concern and only one barrier exists)

bull Using more than one container of shellfish at a time (co-mingling)

bull Serving or offering for sale raw or lightly cooked animal foods in a ready-to- eat form (raw eggs raw marinated fish raw molluscan shell fish steak tartar lightly cooked fish soft cooked eggs undercooked meat other than ldquowhole muscle intact beef) and not wanting to use a consumer advisory

bull Molluscan shellfish display tanks that are used to storedisplay shellfish that are offered for human consumption

bull Brewing alcoholic beverages

bull Preparing serving or transporting food by another method that is determined by the HEALTH DEPARTMENT to require a variance or HACCP plan

Processes requiring a variance from the State but no HACCP plan

bull Custom processing of animals or fish for personal use in a licensed food Establishment

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 8 of 45 Rev 0

bull Any other requests that vary from the rules of the code where it is determined that a variance is sufficient without a HACCP Plan

Processes requiring a formal HACCP plan and not a variance from the State

bull Pooling of eggs in a food establishment that serves a highly susceptiblepopulation (retirement home nursing home hospital day car etc)

bull Reduced oxygen packaging (where Cbot is a concern and more than one barrier exists) Processes requiring only a written procedure andor approval by the Health Department

bull Using time only as a public health control for potentially hazardous food

bull Use of a two compartment sink for some limited processes

~ A HACCP STUDY - PROCESS FLOW DIAGRAM ~

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Task 1 ASSEMBLY OF OUR HACCP TEAM

821 General

Management shall ensure the establishing of criteria for the selection of team members to assist with the study establishing implementation maintenance and continual improvement of the HACCP system Every team member shall accept in writing his assignment and commitment to the HACCP team

822 The team shall consist of a

a) Team leader

The team leader shall be trained in the requirements as set out in this standard

NOTE The management representative and the team leader may be the same person

b) Team members

The team shall be multi-disciplined and members shall be drawn from each part of the organization likely to be affected for example from production purchasing finance technical engineering quality and distribution The HACCP team shall consist of personnel with specific knowledge of and expertise with regard to the service the food handling process and food safety hazard categories Where appropriate team members with knowledge in the following areas should be considered for inclusion in the team

1) food science

2) microbiology

3) quality control

4) engineering

5) industrial chemistry

6) work studying

7) risk assessment

8) production

9) marketing or sales

10) distribution and

11) food service management

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823 The HACCP team shall establish documentation defining the scope of the HACCP study and the teamrsquos activities The teamrsquos activities should include establishing the following

a) the rules and guidelines for team meetings

b) the criteria used for decision making processes

c) the methodology to be used by the team to determinehazards and CCPs

d) the methodology for reporting on the status of the HACCP system and

e) the methodology for the establishment for procedural requirements orintegration with other relevant management system procedures

824 Where the necessary skills or knowledge are not available within the food handling organization the service of a consultant may be used on condition that the consultant acts only as an expert advisor to the team

Introduction

There are twelve tasks required to develop a HACCP plan and these are designed to ensure that the seven principles are applied correctly Principle 1 which is to conduct a hazard analysis requires that the first five tasks have all been addressed in a logical and honest manner so that all real hazards associated with the commodity have been identified

Establish a HACCP Team

To fully understand the commodity system and be able to identify all likely hazards and CCPs it is important that the HACCP team is made up of people from a wide range of disciplines The team should include

A team leader to convene the group and to direct the work of the team ensuring that the concept is properly applied This person must be familiar with the technique be a good listener and allow all participants to contribute

A specialist with a detailed knowledge of the commodity system is required This specialist will have a major role in the production of the commodity flow diagrams

Several specialists each with an understanding of particular hazards and associated risks eg a microbiologist a chemist a mycotoxicologist a toxicologist a QC manager a process engineer

People such as packaging specialists raw material buyers distribution staff or production staff farmers brokers who are involved with the process and

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 11 of 45 Rev 0

have working knowledge of it may be brought into the team temporarily in order to provide relevant expertise

The teams progress and results of the analysis should be recorded by a technical secretary

If any changes are made to composition or operational procedures it will be necessary to re-assess the HACCP plan in the light of the changes

The first activity of the HACCP team is to identify the scope of the study For example will the whole commodity system be covered or only selected components This will make the task more manageable and specialists can be added to the team as and when they are required

Our HACCP TEAMie Who

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Task 2 DESCRIPTION OF OUR SERVICES

A complete description of the service shall be given in terms of type and composition (allergens microbiological chemical and physical properties) relevant legislation handling processing presentation or packaging storage and distribution condition and the shelf life under prescribed conditions

Describe the Product Service

To start a hazard analysis a full description of the product including customer specification should be prepared This should include information relevant to safety eg mycotoxin regulationtarget level composition physicalchemical properties of the raw materials and the final product the amount of water available for microbial growth (aw) the amount of acid or alkali in the product (pH) Also information regarding how the product is to be packaged stored and transported should also be considered together with facts regarding its shelf life and recommended storage temperatures Where appropriate labelling information and an example of the label should be included This information will help the HACCP team to identify real hazards associated with the process

Activity DescriptionFacility Site

Project Coordinator

Activity

Site Manager

Address

Phone

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SERVICES DESCRIPTIONie What Where amp When

Task 3 IDENTIFYING THE INTENDED USE OF OUR SERVICES

The intended use and possible abuse of the service by consumers consumer groups or customers shall be described Attention shall be focused on the likely uses and abuses of the service after it has left the control of the food handling organization Factors such as the vulnerability of the consumer and instructions for use shall be taken into account

Identify the products Services intended use

How the product is intended to be used is an important consideration Information on whether the product will be consumed directly or be cooked or be further processed will all have a bearing on the hazard analysis see task 6) The nature of the target group for the product may also be relevant particularly if it includes susceptible groups such as infants the elderly and the malnourished The likelihood of misuse of a product should also be considered such as the use of pet food as a human food either by accident or design This information can be recorded on the same form as the product description

INTENDED USE OF OUR SERVICEie Why

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Stage 4 CONSTRUCTION OF OUR SERVICE FLOW DIAGRAM

851 The HACCP team shall prepare a detailed floe diagram for the specified food services or process categories relevant to the defined scope of the HACCP study

852 The following should be considered when preparing the flow diagram

a) the selection of raw material

b) processing activities

d) processing delays

e) packaging and storage

f) distribution retail and customer handling of the service

g) any outsourced processes and

h) removal of intermediary services by-services and waste

853 A floor plan relevant to the areas falling within the defined scope of the HACCP study shall be prepared The following should be considered during the preparation of the floor plan as relevant technical data for an effective evaluation of the service flow

a) layout and design features of equipment

b) service flow of liquids powders raw and cooked foods

c) routes of personnel and their personal hygiene practices

d) service recycle or rework loops

e) routes of potential cross-contamination through movement of materials

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(ingredients returns water packaging materials etc)

f) segregation of high risk areas from low risk areas where a risk of cross-contamination exists

g) storage and distribution conditions of the different materials used in thefood handling process

h) packaging materials used and

I) factory hygiene cleaning and disinfection procedures

Draw up the Commodity Flow Diagram ( CFD )

The first function of the team is to draw up a detailed commodity flow diagram (CFD) of the commodity system or that part of it which is relevant The expertise of the commodity specialist is important at this stage Commodity systems will differ in detail in different parts of the world and even within one country there may be a number of variants Secondary processing will need to be detailed for each facility using generic flows only as a guide

BLANK FOOD SERVICES ndash COMMODITY FLOW DIAGRAMie How

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NOTE For your information only ndash two EXAMPLES of FOOD SERVICESrsquo FLOW DIAGRAMS

1

2

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Receiving

Cooking CCP

Cutting Preparation

Frozen Storage

Cooking CCP

Refrigerated Storage

Serving

Thawing

Serving

Hot Holding CCP

Cooling CCP

Consumption

Reheating CCP

Consumption

Serving

Slicing

Consumption

Serving

Slicing

Cooling CCP

Serving

Hot Holding CCP

Stage 5 ON-SITE CONFIRMATION OF THE COMMODITY FLOWDIAGRAM

The HACCP team shall confirm the accuracy of the flow diagram and the floor plan on site during all stages and hours of operation so as to ensure that the flow diagram floor plan and technical data as described in 853 gives an accurate representation of the operation The flow diagram shall be amended to take into account any deviation from the original diagram

Records shall be kept

On site confirmation of flow diagram

Upon completion of the CFD members of the team should visit the commodity system (eg farm store or manufacturing area) to compare the information present on the CFD with what actually happens in practice This is known as walking the line a step by step practice to check that all information regarding materials practices controls etc have been taken into consideration by the team during the preparation of the CFD Information such as time of harvest drying procedures storage conditions the marketing chain socio-economic factors grading systems and any incentive for improved quality or safety and processing systems should be collected and included in the CFD as appropriate The site for which the HACCP plan is being designed should be visited as many times as possible to ensure that all relevant information has been collected

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Stage 6 LISTING OF OUR FOOD SAFETY HAZARDS AND MEASURESTO CONTROL THE HAZARD

(Principle 1)

871 The HACCP team shall use the confirmed flow diagram including all the technical data as a guide to identify all the potential food safety hazards (inherent and introduced) that might reasonably be expected to occur at each step of the food handling process Relevant legislation related to the food safety hazards and their control shall be considered The hazards shall be considered in the light of the significance likelihood and severity of such a hazard in terms of the safety of the consumer

872 Control measures for each identified food safety hazard shall be established in order to control such a hazard More than one hazard and control measure might be applicable to one step in the process and more than one control measure might be necessary to control a particular hazard

873 Records shall be kept

Identify and analyse hazard(s)

Effective hazard identification and hazard analysis are the keys to a successful HACCP Plan All real or potential hazards that may occur in each ingredient and at each stage of the commodity system should be considered Food safety hazards for HACCP programmes have been classified into three types of hazards

Biological typically foodborne bacterial pathogens such as Salmonella Listeria and E coli also viruses algae parasites and fungi

Chemical There are three principle types of chemical toxins found in foods naturally occurring chemicals eg cyanides in some root crops and allergenic compounds in peanuts toxins produced by micro-organisms eg mycotoxins

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and algal toxins and chemicals added to the commodity by man to control an identified problem eg fungicides or insecticides

Physical contaminants such as broken glass metal fragments insects or stones

The probability that a hazard will occur is called a risk The risk may take a value from zero to one depending on the degree of certainty that the hazard will be absent or that it will be present After hazard identification a hazard analysis must be conducted to understand the relative health risk to man or animal posed by the hazard It is a way of organizing and analyzing the available scientific information on the nature and size of the health risk associated with the hazard The risk may have to be assessed subjectively and simply classified as low medium or high Only those hazards considered by the HACCP team to present an unacceptable risk of being present are taken forward to Stage 7 Principle 2

Once a food safety hazard has been identified then appropriate control measures should be considered These are any action or activity that can be used to control the identified hazard such that it is prevented eliminated or reduced to an acceptable level The control measure may also include training of personnel for a particular operation covered by Good Manufacturing Processes ( GMP)

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

To identify all biological chemical physical and allergen hazards associated with the purchasing delivering storing usage and sale of BLANKrsquos services

Biological Hazards

The following biological hazards were covered by the terms of reference of our HACCP study

1 Yeast amp Moulds2 Coliforms3 E coli4 Listeria5 Salmonella6 Enterobacteriaceae7 Aerobic Mesophile8 Salmonella spp

Chemical Hazards

The following chemical hazards were covered by the terms of reference of our HACCP study

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1 Cleaning residues2 Printing inks lacquers from packaging3 Chemical contaminants and residues in raw materials

Physical Hazards

The following physical hazards were covered by the terms of reference of our HACCP study

1 Metal2 Glass3 Hair4 Wooden splinters5 Dust dirt particles6 Plastic7 Insects

Allergen Hazards

All the following common allergens were considered as part of our HACCP study

1 Milk2 Egg3 Nuts4 Soya5 Gluten6 Crustaceans7 Fish8 Peanuts9 Celery10 Mustard11 Sesame Seeds12 Sulphites13 Lupin14 Molluscs and products thereof

CHEMICALS USED IN FOOD PROCESSINGPoint of use Type of chemicalGrowing crops Pesticides herbicides defoliants Raising livestock Growth hormones antibiotics Production Food additives processing aids Plant maintenance

Lubricants paints solvents

Plant sanitation Cleaners sanitizing agents pesticides

SOME FOOD-BORNE BIOLOGICAL HAZARDS

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Bacteria Parasites Seafood toxinsAeromonas hydrophila

Anisakis spp Ciguatera fish poisoning

Bacillus cereus Ascaris lumbricoides Gempylotoxin Brucella spp Cyclospora

cayetanensisTetrodotoxin

Campylobacter jejuni

Cryptosporidium parvum

Scombrotoxin ( histamine )

Clostridium botulinum

Diphyllobothrium spp Paralytic neurotoxic and

Clostridium perfringens

Entamoeba histolytica Diarrhetic shellfish poisoning

Listeria monocytogenes

Giardia lamblia

Pathogenic Escherichia coli

Taenia spp

Plesiomonas shigelloides

Viruses

Salmonella spp Hepatitis A virusShigella spp Mycotoxigenic moulds PoliovirusesStaphylococcus aureus

Aspergillus spp Norwalk virus group

Streptococcus pyogenes

Fusarium spp

Vibrio cholera Penicillium sppV parahaemolyticusV vulnificusYersinia enterocolitica

EXAMPLES OF PHYSICAL HAZARDS amp THEIR SOURCESPhysical hazard

Source

Metal Bolts nuts screws screens sieves steel woolGlass Light bulbs watch crystals thermometers etcWood splinters Pallets equipment bracing overhead structureInsects Environment electrocution traps incoming ingredients Hair Meat ingredients employees clothing rodentsMould Poor sanitation inadequate cleaning of equipmentRodents droppings

Inadequate rodent controls incoming ingredients

Dirt rocks Raw materials poor employee practices Paint flakes Equipment overhead structureBand-aid Poor employee practicesPen caps Poor employee practicesCarcass ID tags Slaughterhouse

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Hypodermic needles

Veterinarian

Bullets shot BBs

Animals shot while in fields

Feathers Poor sanitation inadequate pest ( bird ) controls Gasket material Inadequate preventive maintenance of equipment Grease Poor equipment maintenance programme

NB Please refer to the generic Hazard Analysis Questionnaire ( under CHECKLISTS ) ndash this checklist is for PER PRODUCT USED

INFO can also be obtained from the productsrsquo MSDS ( MATERIAL SAFETY DATASHEET ) AND OR The Productsrsquo Ingredients Listing

EXAMPLE 1 OF HACCP DECISION TREE

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Q1 Does this step involve a hazard of sufficient likelihood of occurrence and severity to warrant its control

Q3 Is control at this step necessary to prevent eliminate or reduce the risk of hazard to consumers

Modify step process or product

Yes

Is control at this step necessary for safety

Q2 Does a control measure for the hazard exist at this step

Yes

Yes

Yes

No

No

No

No

Not a CCP

This is a critical control point

Not a CCP

Not a CCP

EXAMPLE 2 OF HACCP DECISION TREE

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Q2 Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level

No

Yes

Q1 Do control measure(s) exist for the identified hazard

Modify step process or product

Q4 Will a subsequent step prior to consuming the food eliminate the identified hazard(s) or reduce the likely occurrence to an acceptable level

Q3 Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable level(s)

Yes

Yes

Yes

Yes

No

No

No

Is control at this step necessary for safety

Not a CCP

Not a CCP

This is a critical control point

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

Biological Hazards123456789101112131415

Chemical Hazards123456789101112131415

Physical Hazards12

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 25 of 45 Rev 0

3

456789101112131415

Allergen Hazards123456789101112131415

Stage 7 DETERMINING CRITICAL CONTROL POINT (CCPS) (DECISION TREE)

(Principle 2)

The HACCP team shall determine whether a particular step in the food handling process is a CCP

The method by which a CCP is determined shall be recorder

NOTE The decision tree in annex B can be as a guideline

INTRODUCTION

A Critical Control Point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level

If a hazard has been identified at a step where control is necessary for safety and no control measure exists at that step or any other then the product or process should be modified at that step or at any earlier or later stage to include a control measure

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Determine the Critical Control Points (CCPs)

Each step in the commodity flow diagram within the scope of the HACCP study should be taken in turn and the relevance of each identified hazard should be considered It is also important to remember the stated scope of the HACCP analysis at this stage The team must determine whether the hazard can occur at this step and if so whether control measures exist If the hazard can be controlled adequately and is not best controlled at another step and is essential for food safety then this step is a CCP for the specified hazard A decision tree can be used to determine CCPs However the HACCP teams judgement expertise and knowledge of the process are the major factors in establishing CCPs

If a step is identified where a food safety hazard exists but no adequate control measures can be put in place either at this step or subsequently then the product is unsafe for human consumption Production should cease until control measures are available and a CCP can be introduced

The proper identification of Critical Control Points (CCPs) is crucial to the ultimate effectiveness of a HACCP plan The plan must specify where each identified hazard will be controlled

Hazards that cannot be controlled by the operator must be identified on the HACCP plan The plan must indicate how these hazards will be addressed outside the establishment (ie purchasing pre-frozen fish where the supplier is responsible for the freezing requirements as specified by regulation)

Note The evaluation for completeness of the written CCPs will ensure that all relevant information dealing with critical limits monitoring corrective actions verification procedures and record keeping is specified for each identified hazard

D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S ( C C P S )( C C P S ) (HACCP principle 2)

The determination of a CCP in the HACCP system shall be facilitated using a decision tree ndash as is shown in the following diagram

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 27 of 45 Rev 0

HACCP concept element Application step amp principle

Define the food and the processes involved in production

Break down the process into steps

Determine possible hazards associated with each step and probability of hazard persistence in end product if no affective preventive measures are implemented

Specify control measures

Consequently determine critical control points ( CCPs )

Establish critical limits

Monitor CCPs to ensure proper implementation of control measures

Take corrective action when parameter monitoring indicates failure of control measure

HACCP principles 4 and 5

Application steps 9-10

HACCP principles 2 and 3

Application steps 7-8

HACCP principle 1

Application step 6

Application steps 1-5

System to be reviewed confirmed and audited

Records must be generated for the system to be documented

HACCP principles 6 and 7

Application steps 11-12

Stage 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP (Principle 3)

The HACCP team shall establish specific and measurable critical limits appropriate for each CCP Critical limits that can be measured quickly and easily shall be used Measurements can include sensory examination mass measurements temperature measurements time moisture level PH value and chemical analysis

Records shall be kept

Establish critical limits for each CCP

Critical limits must be specified and validated for each CCP Criteria often used include measurements of temperature time moisture level pH water activity and sensory parameters such as visual appearance In the case of mycotoxins for example they may include the moisture content or the temperature of the commodity All critical limits and the associated permissible tolerances must be documented in the HACCP Plan Worksheet and included as specifications in operating procedures and work instructions

ie Critical limits have to be established for all critical components associated with each hazard that is controlled by a CCP

Critical Limits must meet or exceed relevant regulatory and program requirements Some establishments set critical limits to exceed regulatory requirements This is acceptable but the establishment should be made aware that if these limits are the ones written into the HACCP plan the inspection will be conducted against these more stringent limits

Critical limits normally include measurements such as temperature time moisture level pH aw available chlorine and sensory attributes When applicable compare the critical limits found the establishment HACCP plan to those considered standard industry practice

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For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

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upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

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8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 37 of 45 Rev 0

81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

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acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

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Page 4: BLANK HACCP STUDY

Key Terms

~ aw

A measure of the free moisture in a food is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature

~ Control Point

Any point in a specific food system at which loss of control does not lead to an unacceptable health risk

~ Critical Control Point

A point or procedure in a specific food system where loss of control may result in an unacceptable health risk

~ Critical Limit

The maximum or minimum value to which a physical biological or chemical parameter must be controlled at a critical control point to minimize risk that the identified food safety hazard may occur

~ Deviation

Failure to meet a required critical limit for a critical control point

~ Good Retail Practices (GRPs)

Preventive measures that include practices and procedures to effectively control the introduction of pathogens chemicals and physical objects into food that are prerequisites to instituting a HACCP or Risk Control Plan and are not addressed by the Food Code interventions or risk factors

~ HACCP

An acronym for Hazard Analysis Critical Control Point

~ Hazard Analysis Critical Control Point (HACCP)

A prevention-based food safety system that identifies and monitors specific food safety hazards that can adversely affect the safety of food products

~ HACCP Plan

A written document that delineates the formal procedures for following the Hazard Analysis Critical Control Point principles developed by the National Advisory Committee for the Microbiological Criteria for Foods

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~ HACCP System

The result of implementing the HACCP principles in an operation that has foundational comprehensive prerequisite programs in place A HACCP system includes the HACCP plan and all prerequisite programs

~ Hazard

A biological chemical or physical property that may cause an unacceptable consumer health risk

~ Hazard Analysis

The process of collecting and evaluating information about hazards associated with the food under consideration to decide which are significant and must be addressed in the HACCP plan

~ Monitoring

A planned sequence of observations or measurements of critical limits designed to produce an accurate record and intended to ensure that the critical limit maintains product safety Continuous monitoring means an interrupted record of data

~ pH

The symbol for the negative logarithm of the hydrogen ion concentration which is a measure of the degree of acidity or alkalinity of a solution

~ Potentially Hazardous Food l

A food that is natural or synthetic and that requires temperature control because it is in a form capable of supporting the rapid and progressive growth of infectious or toxigenic micro organisms the growth and toxin production of Clostridium botulinum or in raw shell eggs the growth of Salmonella

~ Enteritidis

Prerequisites for HACCP

Practices and conditions needed prior to and during the implementation of HACCP and which are essential for food safety as described in Codex Alimentarius Commissionrsquos Principles of Food Hygiene and other Codes of

~ Practice

Preventive MeasureAn action to exclude destroy eliminate or reduce a hazard and prevent recontamination through effective means

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~ Risk

The likelihood that an adverse health effect will occur within a population as a result of a hazard in a food

~ Risk Factor

One of the factors identified by the Centres for Disease Control and Prevention (CDC) as a contributor to the foodborne outbreaks that have been investigated and confirmed The factors are unsafe sources inadequate cooking improper holding contaminated equipment and poor personal hygiene

~ Severity

The seriousness of the effect(s) of a hazard

~ Standard Operating Procedure (SOP)

A detailed set of instructions steps or procedures that control the operational conditions within a food establishment allowing for environmental conditions that are favourable to the production of safe food These written procedures are often equivalent to prerequisite programs of HACCP The extent to which operators employ various SOPs will determine which critical control points need to be controlled

~ Validation

Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

~ Verification

Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

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HACCP Overview

Simply stated Hazard Analysis Critical Control Point (HACCP) is a logical and thorough process control system designed to identify and control hazards HACCP focuses on prevention and control of food safety problems at highly specific (and controllable) points in the process chain Implementing a well-designed HACCP program provides food manufacturers and food handlers a high level of control over product safety

HACCP has been around since the 1960rsquos when the Pillsbury Company introduced it in the production of foods for the space program The application of HACCP is based on sound technical and scientific principles that assure food safety Recently numerous meat and poultry operations have been mandated to utilize HACCP to address concerns with food safety

HACCP plans should be specific for each operation Committed personnel involved in the processing operation should conduct the design and implementation of a HACCP plan

Although many of the larger food establishments and chains have the expertise available to develop and implement HACCP systems some of the smaller establishments may require assistance from university extension programs industry associations consultants and government for development of their plans

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SPECIALIZED PROCESSES amp PROCEDURES REQUIRING A HACCP PLAN

Use of food additives or adding components such as vinegar as a method of food preservation or to render a food so that it is not potentially hazardous Use of unpasteurized whole shell eggs in highly susceptible population (HSP) operations to prepare food in quantities other than single service portions Reduced oxygen packaging (ROP) with barriers

1 Custom processing animals2 Molluscan shellfish tanks3 Smoking for preservation4 Curing5 Time as a public health control6 Preventing contamination from hands

Processes requiring a variance from the State and a formal HACCP plan

bull Smoking food as a method of preservation but not if smoking only forflavor enhancement (using smoking solely for preservation is rarely if ever done)

bull Curing foods such as hams sausages etc

bull Using food additives or adding components such as vinegar as a methodof food preservation or to render a food so that it is not potentially hazardous)

bull Reduced Oxygen Packaging (where CBot is a concern and only one barrier exists)

bull Using more than one container of shellfish at a time (co-mingling)

bull Serving or offering for sale raw or lightly cooked animal foods in a ready-to- eat form (raw eggs raw marinated fish raw molluscan shell fish steak tartar lightly cooked fish soft cooked eggs undercooked meat other than ldquowhole muscle intact beef) and not wanting to use a consumer advisory

bull Molluscan shellfish display tanks that are used to storedisplay shellfish that are offered for human consumption

bull Brewing alcoholic beverages

bull Preparing serving or transporting food by another method that is determined by the HEALTH DEPARTMENT to require a variance or HACCP plan

Processes requiring a variance from the State but no HACCP plan

bull Custom processing of animals or fish for personal use in a licensed food Establishment

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bull Any other requests that vary from the rules of the code where it is determined that a variance is sufficient without a HACCP Plan

Processes requiring a formal HACCP plan and not a variance from the State

bull Pooling of eggs in a food establishment that serves a highly susceptiblepopulation (retirement home nursing home hospital day car etc)

bull Reduced oxygen packaging (where Cbot is a concern and more than one barrier exists) Processes requiring only a written procedure andor approval by the Health Department

bull Using time only as a public health control for potentially hazardous food

bull Use of a two compartment sink for some limited processes

~ A HACCP STUDY - PROCESS FLOW DIAGRAM ~

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Task 1 ASSEMBLY OF OUR HACCP TEAM

821 General

Management shall ensure the establishing of criteria for the selection of team members to assist with the study establishing implementation maintenance and continual improvement of the HACCP system Every team member shall accept in writing his assignment and commitment to the HACCP team

822 The team shall consist of a

a) Team leader

The team leader shall be trained in the requirements as set out in this standard

NOTE The management representative and the team leader may be the same person

b) Team members

The team shall be multi-disciplined and members shall be drawn from each part of the organization likely to be affected for example from production purchasing finance technical engineering quality and distribution The HACCP team shall consist of personnel with specific knowledge of and expertise with regard to the service the food handling process and food safety hazard categories Where appropriate team members with knowledge in the following areas should be considered for inclusion in the team

1) food science

2) microbiology

3) quality control

4) engineering

5) industrial chemistry

6) work studying

7) risk assessment

8) production

9) marketing or sales

10) distribution and

11) food service management

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823 The HACCP team shall establish documentation defining the scope of the HACCP study and the teamrsquos activities The teamrsquos activities should include establishing the following

a) the rules and guidelines for team meetings

b) the criteria used for decision making processes

c) the methodology to be used by the team to determinehazards and CCPs

d) the methodology for reporting on the status of the HACCP system and

e) the methodology for the establishment for procedural requirements orintegration with other relevant management system procedures

824 Where the necessary skills or knowledge are not available within the food handling organization the service of a consultant may be used on condition that the consultant acts only as an expert advisor to the team

Introduction

There are twelve tasks required to develop a HACCP plan and these are designed to ensure that the seven principles are applied correctly Principle 1 which is to conduct a hazard analysis requires that the first five tasks have all been addressed in a logical and honest manner so that all real hazards associated with the commodity have been identified

Establish a HACCP Team

To fully understand the commodity system and be able to identify all likely hazards and CCPs it is important that the HACCP team is made up of people from a wide range of disciplines The team should include

A team leader to convene the group and to direct the work of the team ensuring that the concept is properly applied This person must be familiar with the technique be a good listener and allow all participants to contribute

A specialist with a detailed knowledge of the commodity system is required This specialist will have a major role in the production of the commodity flow diagrams

Several specialists each with an understanding of particular hazards and associated risks eg a microbiologist a chemist a mycotoxicologist a toxicologist a QC manager a process engineer

People such as packaging specialists raw material buyers distribution staff or production staff farmers brokers who are involved with the process and

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have working knowledge of it may be brought into the team temporarily in order to provide relevant expertise

The teams progress and results of the analysis should be recorded by a technical secretary

If any changes are made to composition or operational procedures it will be necessary to re-assess the HACCP plan in the light of the changes

The first activity of the HACCP team is to identify the scope of the study For example will the whole commodity system be covered or only selected components This will make the task more manageable and specialists can be added to the team as and when they are required

Our HACCP TEAMie Who

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Task 2 DESCRIPTION OF OUR SERVICES

A complete description of the service shall be given in terms of type and composition (allergens microbiological chemical and physical properties) relevant legislation handling processing presentation or packaging storage and distribution condition and the shelf life under prescribed conditions

Describe the Product Service

To start a hazard analysis a full description of the product including customer specification should be prepared This should include information relevant to safety eg mycotoxin regulationtarget level composition physicalchemical properties of the raw materials and the final product the amount of water available for microbial growth (aw) the amount of acid or alkali in the product (pH) Also information regarding how the product is to be packaged stored and transported should also be considered together with facts regarding its shelf life and recommended storage temperatures Where appropriate labelling information and an example of the label should be included This information will help the HACCP team to identify real hazards associated with the process

Activity DescriptionFacility Site

Project Coordinator

Activity

Site Manager

Address

Phone

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SERVICES DESCRIPTIONie What Where amp When

Task 3 IDENTIFYING THE INTENDED USE OF OUR SERVICES

The intended use and possible abuse of the service by consumers consumer groups or customers shall be described Attention shall be focused on the likely uses and abuses of the service after it has left the control of the food handling organization Factors such as the vulnerability of the consumer and instructions for use shall be taken into account

Identify the products Services intended use

How the product is intended to be used is an important consideration Information on whether the product will be consumed directly or be cooked or be further processed will all have a bearing on the hazard analysis see task 6) The nature of the target group for the product may also be relevant particularly if it includes susceptible groups such as infants the elderly and the malnourished The likelihood of misuse of a product should also be considered such as the use of pet food as a human food either by accident or design This information can be recorded on the same form as the product description

INTENDED USE OF OUR SERVICEie Why

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Stage 4 CONSTRUCTION OF OUR SERVICE FLOW DIAGRAM

851 The HACCP team shall prepare a detailed floe diagram for the specified food services or process categories relevant to the defined scope of the HACCP study

852 The following should be considered when preparing the flow diagram

a) the selection of raw material

b) processing activities

d) processing delays

e) packaging and storage

f) distribution retail and customer handling of the service

g) any outsourced processes and

h) removal of intermediary services by-services and waste

853 A floor plan relevant to the areas falling within the defined scope of the HACCP study shall be prepared The following should be considered during the preparation of the floor plan as relevant technical data for an effective evaluation of the service flow

a) layout and design features of equipment

b) service flow of liquids powders raw and cooked foods

c) routes of personnel and their personal hygiene practices

d) service recycle or rework loops

e) routes of potential cross-contamination through movement of materials

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(ingredients returns water packaging materials etc)

f) segregation of high risk areas from low risk areas where a risk of cross-contamination exists

g) storage and distribution conditions of the different materials used in thefood handling process

h) packaging materials used and

I) factory hygiene cleaning and disinfection procedures

Draw up the Commodity Flow Diagram ( CFD )

The first function of the team is to draw up a detailed commodity flow diagram (CFD) of the commodity system or that part of it which is relevant The expertise of the commodity specialist is important at this stage Commodity systems will differ in detail in different parts of the world and even within one country there may be a number of variants Secondary processing will need to be detailed for each facility using generic flows only as a guide

BLANK FOOD SERVICES ndash COMMODITY FLOW DIAGRAMie How

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NOTE For your information only ndash two EXAMPLES of FOOD SERVICESrsquo FLOW DIAGRAMS

1

2

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Receiving

Cooking CCP

Cutting Preparation

Frozen Storage

Cooking CCP

Refrigerated Storage

Serving

Thawing

Serving

Hot Holding CCP

Cooling CCP

Consumption

Reheating CCP

Consumption

Serving

Slicing

Consumption

Serving

Slicing

Cooling CCP

Serving

Hot Holding CCP

Stage 5 ON-SITE CONFIRMATION OF THE COMMODITY FLOWDIAGRAM

The HACCP team shall confirm the accuracy of the flow diagram and the floor plan on site during all stages and hours of operation so as to ensure that the flow diagram floor plan and technical data as described in 853 gives an accurate representation of the operation The flow diagram shall be amended to take into account any deviation from the original diagram

Records shall be kept

On site confirmation of flow diagram

Upon completion of the CFD members of the team should visit the commodity system (eg farm store or manufacturing area) to compare the information present on the CFD with what actually happens in practice This is known as walking the line a step by step practice to check that all information regarding materials practices controls etc have been taken into consideration by the team during the preparation of the CFD Information such as time of harvest drying procedures storage conditions the marketing chain socio-economic factors grading systems and any incentive for improved quality or safety and processing systems should be collected and included in the CFD as appropriate The site for which the HACCP plan is being designed should be visited as many times as possible to ensure that all relevant information has been collected

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Stage 6 LISTING OF OUR FOOD SAFETY HAZARDS AND MEASURESTO CONTROL THE HAZARD

(Principle 1)

871 The HACCP team shall use the confirmed flow diagram including all the technical data as a guide to identify all the potential food safety hazards (inherent and introduced) that might reasonably be expected to occur at each step of the food handling process Relevant legislation related to the food safety hazards and their control shall be considered The hazards shall be considered in the light of the significance likelihood and severity of such a hazard in terms of the safety of the consumer

872 Control measures for each identified food safety hazard shall be established in order to control such a hazard More than one hazard and control measure might be applicable to one step in the process and more than one control measure might be necessary to control a particular hazard

873 Records shall be kept

Identify and analyse hazard(s)

Effective hazard identification and hazard analysis are the keys to a successful HACCP Plan All real or potential hazards that may occur in each ingredient and at each stage of the commodity system should be considered Food safety hazards for HACCP programmes have been classified into three types of hazards

Biological typically foodborne bacterial pathogens such as Salmonella Listeria and E coli also viruses algae parasites and fungi

Chemical There are three principle types of chemical toxins found in foods naturally occurring chemicals eg cyanides in some root crops and allergenic compounds in peanuts toxins produced by micro-organisms eg mycotoxins

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and algal toxins and chemicals added to the commodity by man to control an identified problem eg fungicides or insecticides

Physical contaminants such as broken glass metal fragments insects or stones

The probability that a hazard will occur is called a risk The risk may take a value from zero to one depending on the degree of certainty that the hazard will be absent or that it will be present After hazard identification a hazard analysis must be conducted to understand the relative health risk to man or animal posed by the hazard It is a way of organizing and analyzing the available scientific information on the nature and size of the health risk associated with the hazard The risk may have to be assessed subjectively and simply classified as low medium or high Only those hazards considered by the HACCP team to present an unacceptable risk of being present are taken forward to Stage 7 Principle 2

Once a food safety hazard has been identified then appropriate control measures should be considered These are any action or activity that can be used to control the identified hazard such that it is prevented eliminated or reduced to an acceptable level The control measure may also include training of personnel for a particular operation covered by Good Manufacturing Processes ( GMP)

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

To identify all biological chemical physical and allergen hazards associated with the purchasing delivering storing usage and sale of BLANKrsquos services

Biological Hazards

The following biological hazards were covered by the terms of reference of our HACCP study

1 Yeast amp Moulds2 Coliforms3 E coli4 Listeria5 Salmonella6 Enterobacteriaceae7 Aerobic Mesophile8 Salmonella spp

Chemical Hazards

The following chemical hazards were covered by the terms of reference of our HACCP study

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1 Cleaning residues2 Printing inks lacquers from packaging3 Chemical contaminants and residues in raw materials

Physical Hazards

The following physical hazards were covered by the terms of reference of our HACCP study

1 Metal2 Glass3 Hair4 Wooden splinters5 Dust dirt particles6 Plastic7 Insects

Allergen Hazards

All the following common allergens were considered as part of our HACCP study

1 Milk2 Egg3 Nuts4 Soya5 Gluten6 Crustaceans7 Fish8 Peanuts9 Celery10 Mustard11 Sesame Seeds12 Sulphites13 Lupin14 Molluscs and products thereof

CHEMICALS USED IN FOOD PROCESSINGPoint of use Type of chemicalGrowing crops Pesticides herbicides defoliants Raising livestock Growth hormones antibiotics Production Food additives processing aids Plant maintenance

Lubricants paints solvents

Plant sanitation Cleaners sanitizing agents pesticides

SOME FOOD-BORNE BIOLOGICAL HAZARDS

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Bacteria Parasites Seafood toxinsAeromonas hydrophila

Anisakis spp Ciguatera fish poisoning

Bacillus cereus Ascaris lumbricoides Gempylotoxin Brucella spp Cyclospora

cayetanensisTetrodotoxin

Campylobacter jejuni

Cryptosporidium parvum

Scombrotoxin ( histamine )

Clostridium botulinum

Diphyllobothrium spp Paralytic neurotoxic and

Clostridium perfringens

Entamoeba histolytica Diarrhetic shellfish poisoning

Listeria monocytogenes

Giardia lamblia

Pathogenic Escherichia coli

Taenia spp

Plesiomonas shigelloides

Viruses

Salmonella spp Hepatitis A virusShigella spp Mycotoxigenic moulds PoliovirusesStaphylococcus aureus

Aspergillus spp Norwalk virus group

Streptococcus pyogenes

Fusarium spp

Vibrio cholera Penicillium sppV parahaemolyticusV vulnificusYersinia enterocolitica

EXAMPLES OF PHYSICAL HAZARDS amp THEIR SOURCESPhysical hazard

Source

Metal Bolts nuts screws screens sieves steel woolGlass Light bulbs watch crystals thermometers etcWood splinters Pallets equipment bracing overhead structureInsects Environment electrocution traps incoming ingredients Hair Meat ingredients employees clothing rodentsMould Poor sanitation inadequate cleaning of equipmentRodents droppings

Inadequate rodent controls incoming ingredients

Dirt rocks Raw materials poor employee practices Paint flakes Equipment overhead structureBand-aid Poor employee practicesPen caps Poor employee practicesCarcass ID tags Slaughterhouse

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Hypodermic needles

Veterinarian

Bullets shot BBs

Animals shot while in fields

Feathers Poor sanitation inadequate pest ( bird ) controls Gasket material Inadequate preventive maintenance of equipment Grease Poor equipment maintenance programme

NB Please refer to the generic Hazard Analysis Questionnaire ( under CHECKLISTS ) ndash this checklist is for PER PRODUCT USED

INFO can also be obtained from the productsrsquo MSDS ( MATERIAL SAFETY DATASHEET ) AND OR The Productsrsquo Ingredients Listing

EXAMPLE 1 OF HACCP DECISION TREE

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Q1 Does this step involve a hazard of sufficient likelihood of occurrence and severity to warrant its control

Q3 Is control at this step necessary to prevent eliminate or reduce the risk of hazard to consumers

Modify step process or product

Yes

Is control at this step necessary for safety

Q2 Does a control measure for the hazard exist at this step

Yes

Yes

Yes

No

No

No

No

Not a CCP

This is a critical control point

Not a CCP

Not a CCP

EXAMPLE 2 OF HACCP DECISION TREE

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Q2 Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level

No

Yes

Q1 Do control measure(s) exist for the identified hazard

Modify step process or product

Q4 Will a subsequent step prior to consuming the food eliminate the identified hazard(s) or reduce the likely occurrence to an acceptable level

Q3 Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable level(s)

Yes

Yes

Yes

Yes

No

No

No

Is control at this step necessary for safety

Not a CCP

Not a CCP

This is a critical control point

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

Biological Hazards123456789101112131415

Chemical Hazards123456789101112131415

Physical Hazards12

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3

456789101112131415

Allergen Hazards123456789101112131415

Stage 7 DETERMINING CRITICAL CONTROL POINT (CCPS) (DECISION TREE)

(Principle 2)

The HACCP team shall determine whether a particular step in the food handling process is a CCP

The method by which a CCP is determined shall be recorder

NOTE The decision tree in annex B can be as a guideline

INTRODUCTION

A Critical Control Point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level

If a hazard has been identified at a step where control is necessary for safety and no control measure exists at that step or any other then the product or process should be modified at that step or at any earlier or later stage to include a control measure

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Determine the Critical Control Points (CCPs)

Each step in the commodity flow diagram within the scope of the HACCP study should be taken in turn and the relevance of each identified hazard should be considered It is also important to remember the stated scope of the HACCP analysis at this stage The team must determine whether the hazard can occur at this step and if so whether control measures exist If the hazard can be controlled adequately and is not best controlled at another step and is essential for food safety then this step is a CCP for the specified hazard A decision tree can be used to determine CCPs However the HACCP teams judgement expertise and knowledge of the process are the major factors in establishing CCPs

If a step is identified where a food safety hazard exists but no adequate control measures can be put in place either at this step or subsequently then the product is unsafe for human consumption Production should cease until control measures are available and a CCP can be introduced

The proper identification of Critical Control Points (CCPs) is crucial to the ultimate effectiveness of a HACCP plan The plan must specify where each identified hazard will be controlled

Hazards that cannot be controlled by the operator must be identified on the HACCP plan The plan must indicate how these hazards will be addressed outside the establishment (ie purchasing pre-frozen fish where the supplier is responsible for the freezing requirements as specified by regulation)

Note The evaluation for completeness of the written CCPs will ensure that all relevant information dealing with critical limits monitoring corrective actions verification procedures and record keeping is specified for each identified hazard

D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S ( C C P S )( C C P S ) (HACCP principle 2)

The determination of a CCP in the HACCP system shall be facilitated using a decision tree ndash as is shown in the following diagram

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HACCP concept element Application step amp principle

Define the food and the processes involved in production

Break down the process into steps

Determine possible hazards associated with each step and probability of hazard persistence in end product if no affective preventive measures are implemented

Specify control measures

Consequently determine critical control points ( CCPs )

Establish critical limits

Monitor CCPs to ensure proper implementation of control measures

Take corrective action when parameter monitoring indicates failure of control measure

HACCP principles 4 and 5

Application steps 9-10

HACCP principles 2 and 3

Application steps 7-8

HACCP principle 1

Application step 6

Application steps 1-5

System to be reviewed confirmed and audited

Records must be generated for the system to be documented

HACCP principles 6 and 7

Application steps 11-12

Stage 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP (Principle 3)

The HACCP team shall establish specific and measurable critical limits appropriate for each CCP Critical limits that can be measured quickly and easily shall be used Measurements can include sensory examination mass measurements temperature measurements time moisture level PH value and chemical analysis

Records shall be kept

Establish critical limits for each CCP

Critical limits must be specified and validated for each CCP Criteria often used include measurements of temperature time moisture level pH water activity and sensory parameters such as visual appearance In the case of mycotoxins for example they may include the moisture content or the temperature of the commodity All critical limits and the associated permissible tolerances must be documented in the HACCP Plan Worksheet and included as specifications in operating procedures and work instructions

ie Critical limits have to be established for all critical components associated with each hazard that is controlled by a CCP

Critical Limits must meet or exceed relevant regulatory and program requirements Some establishments set critical limits to exceed regulatory requirements This is acceptable but the establishment should be made aware that if these limits are the ones written into the HACCP plan the inspection will be conducted against these more stringent limits

Critical limits normally include measurements such as temperature time moisture level pH aw available chlorine and sensory attributes When applicable compare the critical limits found the establishment HACCP plan to those considered standard industry practice

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For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

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upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

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8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

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81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 43 of 45 Rev 0

acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

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Page 5: BLANK HACCP STUDY

~ HACCP System

The result of implementing the HACCP principles in an operation that has foundational comprehensive prerequisite programs in place A HACCP system includes the HACCP plan and all prerequisite programs

~ Hazard

A biological chemical or physical property that may cause an unacceptable consumer health risk

~ Hazard Analysis

The process of collecting and evaluating information about hazards associated with the food under consideration to decide which are significant and must be addressed in the HACCP plan

~ Monitoring

A planned sequence of observations or measurements of critical limits designed to produce an accurate record and intended to ensure that the critical limit maintains product safety Continuous monitoring means an interrupted record of data

~ pH

The symbol for the negative logarithm of the hydrogen ion concentration which is a measure of the degree of acidity or alkalinity of a solution

~ Potentially Hazardous Food l

A food that is natural or synthetic and that requires temperature control because it is in a form capable of supporting the rapid and progressive growth of infectious or toxigenic micro organisms the growth and toxin production of Clostridium botulinum or in raw shell eggs the growth of Salmonella

~ Enteritidis

Prerequisites for HACCP

Practices and conditions needed prior to and during the implementation of HACCP and which are essential for food safety as described in Codex Alimentarius Commissionrsquos Principles of Food Hygiene and other Codes of

~ Practice

Preventive MeasureAn action to exclude destroy eliminate or reduce a hazard and prevent recontamination through effective means

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~ Risk

The likelihood that an adverse health effect will occur within a population as a result of a hazard in a food

~ Risk Factor

One of the factors identified by the Centres for Disease Control and Prevention (CDC) as a contributor to the foodborne outbreaks that have been investigated and confirmed The factors are unsafe sources inadequate cooking improper holding contaminated equipment and poor personal hygiene

~ Severity

The seriousness of the effect(s) of a hazard

~ Standard Operating Procedure (SOP)

A detailed set of instructions steps or procedures that control the operational conditions within a food establishment allowing for environmental conditions that are favourable to the production of safe food These written procedures are often equivalent to prerequisite programs of HACCP The extent to which operators employ various SOPs will determine which critical control points need to be controlled

~ Validation

Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

~ Verification

Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

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HACCP Overview

Simply stated Hazard Analysis Critical Control Point (HACCP) is a logical and thorough process control system designed to identify and control hazards HACCP focuses on prevention and control of food safety problems at highly specific (and controllable) points in the process chain Implementing a well-designed HACCP program provides food manufacturers and food handlers a high level of control over product safety

HACCP has been around since the 1960rsquos when the Pillsbury Company introduced it in the production of foods for the space program The application of HACCP is based on sound technical and scientific principles that assure food safety Recently numerous meat and poultry operations have been mandated to utilize HACCP to address concerns with food safety

HACCP plans should be specific for each operation Committed personnel involved in the processing operation should conduct the design and implementation of a HACCP plan

Although many of the larger food establishments and chains have the expertise available to develop and implement HACCP systems some of the smaller establishments may require assistance from university extension programs industry associations consultants and government for development of their plans

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SPECIALIZED PROCESSES amp PROCEDURES REQUIRING A HACCP PLAN

Use of food additives or adding components such as vinegar as a method of food preservation or to render a food so that it is not potentially hazardous Use of unpasteurized whole shell eggs in highly susceptible population (HSP) operations to prepare food in quantities other than single service portions Reduced oxygen packaging (ROP) with barriers

1 Custom processing animals2 Molluscan shellfish tanks3 Smoking for preservation4 Curing5 Time as a public health control6 Preventing contamination from hands

Processes requiring a variance from the State and a formal HACCP plan

bull Smoking food as a method of preservation but not if smoking only forflavor enhancement (using smoking solely for preservation is rarely if ever done)

bull Curing foods such as hams sausages etc

bull Using food additives or adding components such as vinegar as a methodof food preservation or to render a food so that it is not potentially hazardous)

bull Reduced Oxygen Packaging (where CBot is a concern and only one barrier exists)

bull Using more than one container of shellfish at a time (co-mingling)

bull Serving or offering for sale raw or lightly cooked animal foods in a ready-to- eat form (raw eggs raw marinated fish raw molluscan shell fish steak tartar lightly cooked fish soft cooked eggs undercooked meat other than ldquowhole muscle intact beef) and not wanting to use a consumer advisory

bull Molluscan shellfish display tanks that are used to storedisplay shellfish that are offered for human consumption

bull Brewing alcoholic beverages

bull Preparing serving or transporting food by another method that is determined by the HEALTH DEPARTMENT to require a variance or HACCP plan

Processes requiring a variance from the State but no HACCP plan

bull Custom processing of animals or fish for personal use in a licensed food Establishment

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bull Any other requests that vary from the rules of the code where it is determined that a variance is sufficient without a HACCP Plan

Processes requiring a formal HACCP plan and not a variance from the State

bull Pooling of eggs in a food establishment that serves a highly susceptiblepopulation (retirement home nursing home hospital day car etc)

bull Reduced oxygen packaging (where Cbot is a concern and more than one barrier exists) Processes requiring only a written procedure andor approval by the Health Department

bull Using time only as a public health control for potentially hazardous food

bull Use of a two compartment sink for some limited processes

~ A HACCP STUDY - PROCESS FLOW DIAGRAM ~

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Task 1 ASSEMBLY OF OUR HACCP TEAM

821 General

Management shall ensure the establishing of criteria for the selection of team members to assist with the study establishing implementation maintenance and continual improvement of the HACCP system Every team member shall accept in writing his assignment and commitment to the HACCP team

822 The team shall consist of a

a) Team leader

The team leader shall be trained in the requirements as set out in this standard

NOTE The management representative and the team leader may be the same person

b) Team members

The team shall be multi-disciplined and members shall be drawn from each part of the organization likely to be affected for example from production purchasing finance technical engineering quality and distribution The HACCP team shall consist of personnel with specific knowledge of and expertise with regard to the service the food handling process and food safety hazard categories Where appropriate team members with knowledge in the following areas should be considered for inclusion in the team

1) food science

2) microbiology

3) quality control

4) engineering

5) industrial chemistry

6) work studying

7) risk assessment

8) production

9) marketing or sales

10) distribution and

11) food service management

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823 The HACCP team shall establish documentation defining the scope of the HACCP study and the teamrsquos activities The teamrsquos activities should include establishing the following

a) the rules and guidelines for team meetings

b) the criteria used for decision making processes

c) the methodology to be used by the team to determinehazards and CCPs

d) the methodology for reporting on the status of the HACCP system and

e) the methodology for the establishment for procedural requirements orintegration with other relevant management system procedures

824 Where the necessary skills or knowledge are not available within the food handling organization the service of a consultant may be used on condition that the consultant acts only as an expert advisor to the team

Introduction

There are twelve tasks required to develop a HACCP plan and these are designed to ensure that the seven principles are applied correctly Principle 1 which is to conduct a hazard analysis requires that the first five tasks have all been addressed in a logical and honest manner so that all real hazards associated with the commodity have been identified

Establish a HACCP Team

To fully understand the commodity system and be able to identify all likely hazards and CCPs it is important that the HACCP team is made up of people from a wide range of disciplines The team should include

A team leader to convene the group and to direct the work of the team ensuring that the concept is properly applied This person must be familiar with the technique be a good listener and allow all participants to contribute

A specialist with a detailed knowledge of the commodity system is required This specialist will have a major role in the production of the commodity flow diagrams

Several specialists each with an understanding of particular hazards and associated risks eg a microbiologist a chemist a mycotoxicologist a toxicologist a QC manager a process engineer

People such as packaging specialists raw material buyers distribution staff or production staff farmers brokers who are involved with the process and

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 11 of 45 Rev 0

have working knowledge of it may be brought into the team temporarily in order to provide relevant expertise

The teams progress and results of the analysis should be recorded by a technical secretary

If any changes are made to composition or operational procedures it will be necessary to re-assess the HACCP plan in the light of the changes

The first activity of the HACCP team is to identify the scope of the study For example will the whole commodity system be covered or only selected components This will make the task more manageable and specialists can be added to the team as and when they are required

Our HACCP TEAMie Who

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Task 2 DESCRIPTION OF OUR SERVICES

A complete description of the service shall be given in terms of type and composition (allergens microbiological chemical and physical properties) relevant legislation handling processing presentation or packaging storage and distribution condition and the shelf life under prescribed conditions

Describe the Product Service

To start a hazard analysis a full description of the product including customer specification should be prepared This should include information relevant to safety eg mycotoxin regulationtarget level composition physicalchemical properties of the raw materials and the final product the amount of water available for microbial growth (aw) the amount of acid or alkali in the product (pH) Also information regarding how the product is to be packaged stored and transported should also be considered together with facts regarding its shelf life and recommended storage temperatures Where appropriate labelling information and an example of the label should be included This information will help the HACCP team to identify real hazards associated with the process

Activity DescriptionFacility Site

Project Coordinator

Activity

Site Manager

Address

Phone

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SERVICES DESCRIPTIONie What Where amp When

Task 3 IDENTIFYING THE INTENDED USE OF OUR SERVICES

The intended use and possible abuse of the service by consumers consumer groups or customers shall be described Attention shall be focused on the likely uses and abuses of the service after it has left the control of the food handling organization Factors such as the vulnerability of the consumer and instructions for use shall be taken into account

Identify the products Services intended use

How the product is intended to be used is an important consideration Information on whether the product will be consumed directly or be cooked or be further processed will all have a bearing on the hazard analysis see task 6) The nature of the target group for the product may also be relevant particularly if it includes susceptible groups such as infants the elderly and the malnourished The likelihood of misuse of a product should also be considered such as the use of pet food as a human food either by accident or design This information can be recorded on the same form as the product description

INTENDED USE OF OUR SERVICEie Why

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Stage 4 CONSTRUCTION OF OUR SERVICE FLOW DIAGRAM

851 The HACCP team shall prepare a detailed floe diagram for the specified food services or process categories relevant to the defined scope of the HACCP study

852 The following should be considered when preparing the flow diagram

a) the selection of raw material

b) processing activities

d) processing delays

e) packaging and storage

f) distribution retail and customer handling of the service

g) any outsourced processes and

h) removal of intermediary services by-services and waste

853 A floor plan relevant to the areas falling within the defined scope of the HACCP study shall be prepared The following should be considered during the preparation of the floor plan as relevant technical data for an effective evaluation of the service flow

a) layout and design features of equipment

b) service flow of liquids powders raw and cooked foods

c) routes of personnel and their personal hygiene practices

d) service recycle or rework loops

e) routes of potential cross-contamination through movement of materials

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(ingredients returns water packaging materials etc)

f) segregation of high risk areas from low risk areas where a risk of cross-contamination exists

g) storage and distribution conditions of the different materials used in thefood handling process

h) packaging materials used and

I) factory hygiene cleaning and disinfection procedures

Draw up the Commodity Flow Diagram ( CFD )

The first function of the team is to draw up a detailed commodity flow diagram (CFD) of the commodity system or that part of it which is relevant The expertise of the commodity specialist is important at this stage Commodity systems will differ in detail in different parts of the world and even within one country there may be a number of variants Secondary processing will need to be detailed for each facility using generic flows only as a guide

BLANK FOOD SERVICES ndash COMMODITY FLOW DIAGRAMie How

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NOTE For your information only ndash two EXAMPLES of FOOD SERVICESrsquo FLOW DIAGRAMS

1

2

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Receiving

Cooking CCP

Cutting Preparation

Frozen Storage

Cooking CCP

Refrigerated Storage

Serving

Thawing

Serving

Hot Holding CCP

Cooling CCP

Consumption

Reheating CCP

Consumption

Serving

Slicing

Consumption

Serving

Slicing

Cooling CCP

Serving

Hot Holding CCP

Stage 5 ON-SITE CONFIRMATION OF THE COMMODITY FLOWDIAGRAM

The HACCP team shall confirm the accuracy of the flow diagram and the floor plan on site during all stages and hours of operation so as to ensure that the flow diagram floor plan and technical data as described in 853 gives an accurate representation of the operation The flow diagram shall be amended to take into account any deviation from the original diagram

Records shall be kept

On site confirmation of flow diagram

Upon completion of the CFD members of the team should visit the commodity system (eg farm store or manufacturing area) to compare the information present on the CFD with what actually happens in practice This is known as walking the line a step by step practice to check that all information regarding materials practices controls etc have been taken into consideration by the team during the preparation of the CFD Information such as time of harvest drying procedures storage conditions the marketing chain socio-economic factors grading systems and any incentive for improved quality or safety and processing systems should be collected and included in the CFD as appropriate The site for which the HACCP plan is being designed should be visited as many times as possible to ensure that all relevant information has been collected

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Stage 6 LISTING OF OUR FOOD SAFETY HAZARDS AND MEASURESTO CONTROL THE HAZARD

(Principle 1)

871 The HACCP team shall use the confirmed flow diagram including all the technical data as a guide to identify all the potential food safety hazards (inherent and introduced) that might reasonably be expected to occur at each step of the food handling process Relevant legislation related to the food safety hazards and their control shall be considered The hazards shall be considered in the light of the significance likelihood and severity of such a hazard in terms of the safety of the consumer

872 Control measures for each identified food safety hazard shall be established in order to control such a hazard More than one hazard and control measure might be applicable to one step in the process and more than one control measure might be necessary to control a particular hazard

873 Records shall be kept

Identify and analyse hazard(s)

Effective hazard identification and hazard analysis are the keys to a successful HACCP Plan All real or potential hazards that may occur in each ingredient and at each stage of the commodity system should be considered Food safety hazards for HACCP programmes have been classified into three types of hazards

Biological typically foodborne bacterial pathogens such as Salmonella Listeria and E coli also viruses algae parasites and fungi

Chemical There are three principle types of chemical toxins found in foods naturally occurring chemicals eg cyanides in some root crops and allergenic compounds in peanuts toxins produced by micro-organisms eg mycotoxins

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and algal toxins and chemicals added to the commodity by man to control an identified problem eg fungicides or insecticides

Physical contaminants such as broken glass metal fragments insects or stones

The probability that a hazard will occur is called a risk The risk may take a value from zero to one depending on the degree of certainty that the hazard will be absent or that it will be present After hazard identification a hazard analysis must be conducted to understand the relative health risk to man or animal posed by the hazard It is a way of organizing and analyzing the available scientific information on the nature and size of the health risk associated with the hazard The risk may have to be assessed subjectively and simply classified as low medium or high Only those hazards considered by the HACCP team to present an unacceptable risk of being present are taken forward to Stage 7 Principle 2

Once a food safety hazard has been identified then appropriate control measures should be considered These are any action or activity that can be used to control the identified hazard such that it is prevented eliminated or reduced to an acceptable level The control measure may also include training of personnel for a particular operation covered by Good Manufacturing Processes ( GMP)

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

To identify all biological chemical physical and allergen hazards associated with the purchasing delivering storing usage and sale of BLANKrsquos services

Biological Hazards

The following biological hazards were covered by the terms of reference of our HACCP study

1 Yeast amp Moulds2 Coliforms3 E coli4 Listeria5 Salmonella6 Enterobacteriaceae7 Aerobic Mesophile8 Salmonella spp

Chemical Hazards

The following chemical hazards were covered by the terms of reference of our HACCP study

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1 Cleaning residues2 Printing inks lacquers from packaging3 Chemical contaminants and residues in raw materials

Physical Hazards

The following physical hazards were covered by the terms of reference of our HACCP study

1 Metal2 Glass3 Hair4 Wooden splinters5 Dust dirt particles6 Plastic7 Insects

Allergen Hazards

All the following common allergens were considered as part of our HACCP study

1 Milk2 Egg3 Nuts4 Soya5 Gluten6 Crustaceans7 Fish8 Peanuts9 Celery10 Mustard11 Sesame Seeds12 Sulphites13 Lupin14 Molluscs and products thereof

CHEMICALS USED IN FOOD PROCESSINGPoint of use Type of chemicalGrowing crops Pesticides herbicides defoliants Raising livestock Growth hormones antibiotics Production Food additives processing aids Plant maintenance

Lubricants paints solvents

Plant sanitation Cleaners sanitizing agents pesticides

SOME FOOD-BORNE BIOLOGICAL HAZARDS

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Bacteria Parasites Seafood toxinsAeromonas hydrophila

Anisakis spp Ciguatera fish poisoning

Bacillus cereus Ascaris lumbricoides Gempylotoxin Brucella spp Cyclospora

cayetanensisTetrodotoxin

Campylobacter jejuni

Cryptosporidium parvum

Scombrotoxin ( histamine )

Clostridium botulinum

Diphyllobothrium spp Paralytic neurotoxic and

Clostridium perfringens

Entamoeba histolytica Diarrhetic shellfish poisoning

Listeria monocytogenes

Giardia lamblia

Pathogenic Escherichia coli

Taenia spp

Plesiomonas shigelloides

Viruses

Salmonella spp Hepatitis A virusShigella spp Mycotoxigenic moulds PoliovirusesStaphylococcus aureus

Aspergillus spp Norwalk virus group

Streptococcus pyogenes

Fusarium spp

Vibrio cholera Penicillium sppV parahaemolyticusV vulnificusYersinia enterocolitica

EXAMPLES OF PHYSICAL HAZARDS amp THEIR SOURCESPhysical hazard

Source

Metal Bolts nuts screws screens sieves steel woolGlass Light bulbs watch crystals thermometers etcWood splinters Pallets equipment bracing overhead structureInsects Environment electrocution traps incoming ingredients Hair Meat ingredients employees clothing rodentsMould Poor sanitation inadequate cleaning of equipmentRodents droppings

Inadequate rodent controls incoming ingredients

Dirt rocks Raw materials poor employee practices Paint flakes Equipment overhead structureBand-aid Poor employee practicesPen caps Poor employee practicesCarcass ID tags Slaughterhouse

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Hypodermic needles

Veterinarian

Bullets shot BBs

Animals shot while in fields

Feathers Poor sanitation inadequate pest ( bird ) controls Gasket material Inadequate preventive maintenance of equipment Grease Poor equipment maintenance programme

NB Please refer to the generic Hazard Analysis Questionnaire ( under CHECKLISTS ) ndash this checklist is for PER PRODUCT USED

INFO can also be obtained from the productsrsquo MSDS ( MATERIAL SAFETY DATASHEET ) AND OR The Productsrsquo Ingredients Listing

EXAMPLE 1 OF HACCP DECISION TREE

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Q1 Does this step involve a hazard of sufficient likelihood of occurrence and severity to warrant its control

Q3 Is control at this step necessary to prevent eliminate or reduce the risk of hazard to consumers

Modify step process or product

Yes

Is control at this step necessary for safety

Q2 Does a control measure for the hazard exist at this step

Yes

Yes

Yes

No

No

No

No

Not a CCP

This is a critical control point

Not a CCP

Not a CCP

EXAMPLE 2 OF HACCP DECISION TREE

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Q2 Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level

No

Yes

Q1 Do control measure(s) exist for the identified hazard

Modify step process or product

Q4 Will a subsequent step prior to consuming the food eliminate the identified hazard(s) or reduce the likely occurrence to an acceptable level

Q3 Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable level(s)

Yes

Yes

Yes

Yes

No

No

No

Is control at this step necessary for safety

Not a CCP

Not a CCP

This is a critical control point

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

Biological Hazards123456789101112131415

Chemical Hazards123456789101112131415

Physical Hazards12

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 25 of 45 Rev 0

3

456789101112131415

Allergen Hazards123456789101112131415

Stage 7 DETERMINING CRITICAL CONTROL POINT (CCPS) (DECISION TREE)

(Principle 2)

The HACCP team shall determine whether a particular step in the food handling process is a CCP

The method by which a CCP is determined shall be recorder

NOTE The decision tree in annex B can be as a guideline

INTRODUCTION

A Critical Control Point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level

If a hazard has been identified at a step where control is necessary for safety and no control measure exists at that step or any other then the product or process should be modified at that step or at any earlier or later stage to include a control measure

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 26 of 45 Rev 0

Determine the Critical Control Points (CCPs)

Each step in the commodity flow diagram within the scope of the HACCP study should be taken in turn and the relevance of each identified hazard should be considered It is also important to remember the stated scope of the HACCP analysis at this stage The team must determine whether the hazard can occur at this step and if so whether control measures exist If the hazard can be controlled adequately and is not best controlled at another step and is essential for food safety then this step is a CCP for the specified hazard A decision tree can be used to determine CCPs However the HACCP teams judgement expertise and knowledge of the process are the major factors in establishing CCPs

If a step is identified where a food safety hazard exists but no adequate control measures can be put in place either at this step or subsequently then the product is unsafe for human consumption Production should cease until control measures are available and a CCP can be introduced

The proper identification of Critical Control Points (CCPs) is crucial to the ultimate effectiveness of a HACCP plan The plan must specify where each identified hazard will be controlled

Hazards that cannot be controlled by the operator must be identified on the HACCP plan The plan must indicate how these hazards will be addressed outside the establishment (ie purchasing pre-frozen fish where the supplier is responsible for the freezing requirements as specified by regulation)

Note The evaluation for completeness of the written CCPs will ensure that all relevant information dealing with critical limits monitoring corrective actions verification procedures and record keeping is specified for each identified hazard

D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S ( C C P S )( C C P S ) (HACCP principle 2)

The determination of a CCP in the HACCP system shall be facilitated using a decision tree ndash as is shown in the following diagram

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 27 of 45 Rev 0

HACCP concept element Application step amp principle

Define the food and the processes involved in production

Break down the process into steps

Determine possible hazards associated with each step and probability of hazard persistence in end product if no affective preventive measures are implemented

Specify control measures

Consequently determine critical control points ( CCPs )

Establish critical limits

Monitor CCPs to ensure proper implementation of control measures

Take corrective action when parameter monitoring indicates failure of control measure

HACCP principles 4 and 5

Application steps 9-10

HACCP principles 2 and 3

Application steps 7-8

HACCP principle 1

Application step 6

Application steps 1-5

System to be reviewed confirmed and audited

Records must be generated for the system to be documented

HACCP principles 6 and 7

Application steps 11-12

Stage 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP (Principle 3)

The HACCP team shall establish specific and measurable critical limits appropriate for each CCP Critical limits that can be measured quickly and easily shall be used Measurements can include sensory examination mass measurements temperature measurements time moisture level PH value and chemical analysis

Records shall be kept

Establish critical limits for each CCP

Critical limits must be specified and validated for each CCP Criteria often used include measurements of temperature time moisture level pH water activity and sensory parameters such as visual appearance In the case of mycotoxins for example they may include the moisture content or the temperature of the commodity All critical limits and the associated permissible tolerances must be documented in the HACCP Plan Worksheet and included as specifications in operating procedures and work instructions

ie Critical limits have to be established for all critical components associated with each hazard that is controlled by a CCP

Critical Limits must meet or exceed relevant regulatory and program requirements Some establishments set critical limits to exceed regulatory requirements This is acceptable but the establishment should be made aware that if these limits are the ones written into the HACCP plan the inspection will be conducted against these more stringent limits

Critical limits normally include measurements such as temperature time moisture level pH aw available chlorine and sensory attributes When applicable compare the critical limits found the establishment HACCP plan to those considered standard industry practice

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For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

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upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

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8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

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81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

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acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

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Page 6: BLANK HACCP STUDY

~ Risk

The likelihood that an adverse health effect will occur within a population as a result of a hazard in a food

~ Risk Factor

One of the factors identified by the Centres for Disease Control and Prevention (CDC) as a contributor to the foodborne outbreaks that have been investigated and confirmed The factors are unsafe sources inadequate cooking improper holding contaminated equipment and poor personal hygiene

~ Severity

The seriousness of the effect(s) of a hazard

~ Standard Operating Procedure (SOP)

A detailed set of instructions steps or procedures that control the operational conditions within a food establishment allowing for environmental conditions that are favourable to the production of safe food These written procedures are often equivalent to prerequisite programs of HACCP The extent to which operators employ various SOPs will determine which critical control points need to be controlled

~ Validation

Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

~ Verification

Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

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HACCP Overview

Simply stated Hazard Analysis Critical Control Point (HACCP) is a logical and thorough process control system designed to identify and control hazards HACCP focuses on prevention and control of food safety problems at highly specific (and controllable) points in the process chain Implementing a well-designed HACCP program provides food manufacturers and food handlers a high level of control over product safety

HACCP has been around since the 1960rsquos when the Pillsbury Company introduced it in the production of foods for the space program The application of HACCP is based on sound technical and scientific principles that assure food safety Recently numerous meat and poultry operations have been mandated to utilize HACCP to address concerns with food safety

HACCP plans should be specific for each operation Committed personnel involved in the processing operation should conduct the design and implementation of a HACCP plan

Although many of the larger food establishments and chains have the expertise available to develop and implement HACCP systems some of the smaller establishments may require assistance from university extension programs industry associations consultants and government for development of their plans

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SPECIALIZED PROCESSES amp PROCEDURES REQUIRING A HACCP PLAN

Use of food additives or adding components such as vinegar as a method of food preservation or to render a food so that it is not potentially hazardous Use of unpasteurized whole shell eggs in highly susceptible population (HSP) operations to prepare food in quantities other than single service portions Reduced oxygen packaging (ROP) with barriers

1 Custom processing animals2 Molluscan shellfish tanks3 Smoking for preservation4 Curing5 Time as a public health control6 Preventing contamination from hands

Processes requiring a variance from the State and a formal HACCP plan

bull Smoking food as a method of preservation but not if smoking only forflavor enhancement (using smoking solely for preservation is rarely if ever done)

bull Curing foods such as hams sausages etc

bull Using food additives or adding components such as vinegar as a methodof food preservation or to render a food so that it is not potentially hazardous)

bull Reduced Oxygen Packaging (where CBot is a concern and only one barrier exists)

bull Using more than one container of shellfish at a time (co-mingling)

bull Serving or offering for sale raw or lightly cooked animal foods in a ready-to- eat form (raw eggs raw marinated fish raw molluscan shell fish steak tartar lightly cooked fish soft cooked eggs undercooked meat other than ldquowhole muscle intact beef) and not wanting to use a consumer advisory

bull Molluscan shellfish display tanks that are used to storedisplay shellfish that are offered for human consumption

bull Brewing alcoholic beverages

bull Preparing serving or transporting food by another method that is determined by the HEALTH DEPARTMENT to require a variance or HACCP plan

Processes requiring a variance from the State but no HACCP plan

bull Custom processing of animals or fish for personal use in a licensed food Establishment

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bull Any other requests that vary from the rules of the code where it is determined that a variance is sufficient without a HACCP Plan

Processes requiring a formal HACCP plan and not a variance from the State

bull Pooling of eggs in a food establishment that serves a highly susceptiblepopulation (retirement home nursing home hospital day car etc)

bull Reduced oxygen packaging (where Cbot is a concern and more than one barrier exists) Processes requiring only a written procedure andor approval by the Health Department

bull Using time only as a public health control for potentially hazardous food

bull Use of a two compartment sink for some limited processes

~ A HACCP STUDY - PROCESS FLOW DIAGRAM ~

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Task 1 ASSEMBLY OF OUR HACCP TEAM

821 General

Management shall ensure the establishing of criteria for the selection of team members to assist with the study establishing implementation maintenance and continual improvement of the HACCP system Every team member shall accept in writing his assignment and commitment to the HACCP team

822 The team shall consist of a

a) Team leader

The team leader shall be trained in the requirements as set out in this standard

NOTE The management representative and the team leader may be the same person

b) Team members

The team shall be multi-disciplined and members shall be drawn from each part of the organization likely to be affected for example from production purchasing finance technical engineering quality and distribution The HACCP team shall consist of personnel with specific knowledge of and expertise with regard to the service the food handling process and food safety hazard categories Where appropriate team members with knowledge in the following areas should be considered for inclusion in the team

1) food science

2) microbiology

3) quality control

4) engineering

5) industrial chemistry

6) work studying

7) risk assessment

8) production

9) marketing or sales

10) distribution and

11) food service management

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823 The HACCP team shall establish documentation defining the scope of the HACCP study and the teamrsquos activities The teamrsquos activities should include establishing the following

a) the rules and guidelines for team meetings

b) the criteria used for decision making processes

c) the methodology to be used by the team to determinehazards and CCPs

d) the methodology for reporting on the status of the HACCP system and

e) the methodology for the establishment for procedural requirements orintegration with other relevant management system procedures

824 Where the necessary skills or knowledge are not available within the food handling organization the service of a consultant may be used on condition that the consultant acts only as an expert advisor to the team

Introduction

There are twelve tasks required to develop a HACCP plan and these are designed to ensure that the seven principles are applied correctly Principle 1 which is to conduct a hazard analysis requires that the first five tasks have all been addressed in a logical and honest manner so that all real hazards associated with the commodity have been identified

Establish a HACCP Team

To fully understand the commodity system and be able to identify all likely hazards and CCPs it is important that the HACCP team is made up of people from a wide range of disciplines The team should include

A team leader to convene the group and to direct the work of the team ensuring that the concept is properly applied This person must be familiar with the technique be a good listener and allow all participants to contribute

A specialist with a detailed knowledge of the commodity system is required This specialist will have a major role in the production of the commodity flow diagrams

Several specialists each with an understanding of particular hazards and associated risks eg a microbiologist a chemist a mycotoxicologist a toxicologist a QC manager a process engineer

People such as packaging specialists raw material buyers distribution staff or production staff farmers brokers who are involved with the process and

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have working knowledge of it may be brought into the team temporarily in order to provide relevant expertise

The teams progress and results of the analysis should be recorded by a technical secretary

If any changes are made to composition or operational procedures it will be necessary to re-assess the HACCP plan in the light of the changes

The first activity of the HACCP team is to identify the scope of the study For example will the whole commodity system be covered or only selected components This will make the task more manageable and specialists can be added to the team as and when they are required

Our HACCP TEAMie Who

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Task 2 DESCRIPTION OF OUR SERVICES

A complete description of the service shall be given in terms of type and composition (allergens microbiological chemical and physical properties) relevant legislation handling processing presentation or packaging storage and distribution condition and the shelf life under prescribed conditions

Describe the Product Service

To start a hazard analysis a full description of the product including customer specification should be prepared This should include information relevant to safety eg mycotoxin regulationtarget level composition physicalchemical properties of the raw materials and the final product the amount of water available for microbial growth (aw) the amount of acid or alkali in the product (pH) Also information regarding how the product is to be packaged stored and transported should also be considered together with facts regarding its shelf life and recommended storage temperatures Where appropriate labelling information and an example of the label should be included This information will help the HACCP team to identify real hazards associated with the process

Activity DescriptionFacility Site

Project Coordinator

Activity

Site Manager

Address

Phone

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SERVICES DESCRIPTIONie What Where amp When

Task 3 IDENTIFYING THE INTENDED USE OF OUR SERVICES

The intended use and possible abuse of the service by consumers consumer groups or customers shall be described Attention shall be focused on the likely uses and abuses of the service after it has left the control of the food handling organization Factors such as the vulnerability of the consumer and instructions for use shall be taken into account

Identify the products Services intended use

How the product is intended to be used is an important consideration Information on whether the product will be consumed directly or be cooked or be further processed will all have a bearing on the hazard analysis see task 6) The nature of the target group for the product may also be relevant particularly if it includes susceptible groups such as infants the elderly and the malnourished The likelihood of misuse of a product should also be considered such as the use of pet food as a human food either by accident or design This information can be recorded on the same form as the product description

INTENDED USE OF OUR SERVICEie Why

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Stage 4 CONSTRUCTION OF OUR SERVICE FLOW DIAGRAM

851 The HACCP team shall prepare a detailed floe diagram for the specified food services or process categories relevant to the defined scope of the HACCP study

852 The following should be considered when preparing the flow diagram

a) the selection of raw material

b) processing activities

d) processing delays

e) packaging and storage

f) distribution retail and customer handling of the service

g) any outsourced processes and

h) removal of intermediary services by-services and waste

853 A floor plan relevant to the areas falling within the defined scope of the HACCP study shall be prepared The following should be considered during the preparation of the floor plan as relevant technical data for an effective evaluation of the service flow

a) layout and design features of equipment

b) service flow of liquids powders raw and cooked foods

c) routes of personnel and their personal hygiene practices

d) service recycle or rework loops

e) routes of potential cross-contamination through movement of materials

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(ingredients returns water packaging materials etc)

f) segregation of high risk areas from low risk areas where a risk of cross-contamination exists

g) storage and distribution conditions of the different materials used in thefood handling process

h) packaging materials used and

I) factory hygiene cleaning and disinfection procedures

Draw up the Commodity Flow Diagram ( CFD )

The first function of the team is to draw up a detailed commodity flow diagram (CFD) of the commodity system or that part of it which is relevant The expertise of the commodity specialist is important at this stage Commodity systems will differ in detail in different parts of the world and even within one country there may be a number of variants Secondary processing will need to be detailed for each facility using generic flows only as a guide

BLANK FOOD SERVICES ndash COMMODITY FLOW DIAGRAMie How

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NOTE For your information only ndash two EXAMPLES of FOOD SERVICESrsquo FLOW DIAGRAMS

1

2

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Receiving

Cooking CCP

Cutting Preparation

Frozen Storage

Cooking CCP

Refrigerated Storage

Serving

Thawing

Serving

Hot Holding CCP

Cooling CCP

Consumption

Reheating CCP

Consumption

Serving

Slicing

Consumption

Serving

Slicing

Cooling CCP

Serving

Hot Holding CCP

Stage 5 ON-SITE CONFIRMATION OF THE COMMODITY FLOWDIAGRAM

The HACCP team shall confirm the accuracy of the flow diagram and the floor plan on site during all stages and hours of operation so as to ensure that the flow diagram floor plan and technical data as described in 853 gives an accurate representation of the operation The flow diagram shall be amended to take into account any deviation from the original diagram

Records shall be kept

On site confirmation of flow diagram

Upon completion of the CFD members of the team should visit the commodity system (eg farm store or manufacturing area) to compare the information present on the CFD with what actually happens in practice This is known as walking the line a step by step practice to check that all information regarding materials practices controls etc have been taken into consideration by the team during the preparation of the CFD Information such as time of harvest drying procedures storage conditions the marketing chain socio-economic factors grading systems and any incentive for improved quality or safety and processing systems should be collected and included in the CFD as appropriate The site for which the HACCP plan is being designed should be visited as many times as possible to ensure that all relevant information has been collected

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Stage 6 LISTING OF OUR FOOD SAFETY HAZARDS AND MEASURESTO CONTROL THE HAZARD

(Principle 1)

871 The HACCP team shall use the confirmed flow diagram including all the technical data as a guide to identify all the potential food safety hazards (inherent and introduced) that might reasonably be expected to occur at each step of the food handling process Relevant legislation related to the food safety hazards and their control shall be considered The hazards shall be considered in the light of the significance likelihood and severity of such a hazard in terms of the safety of the consumer

872 Control measures for each identified food safety hazard shall be established in order to control such a hazard More than one hazard and control measure might be applicable to one step in the process and more than one control measure might be necessary to control a particular hazard

873 Records shall be kept

Identify and analyse hazard(s)

Effective hazard identification and hazard analysis are the keys to a successful HACCP Plan All real or potential hazards that may occur in each ingredient and at each stage of the commodity system should be considered Food safety hazards for HACCP programmes have been classified into three types of hazards

Biological typically foodborne bacterial pathogens such as Salmonella Listeria and E coli also viruses algae parasites and fungi

Chemical There are three principle types of chemical toxins found in foods naturally occurring chemicals eg cyanides in some root crops and allergenic compounds in peanuts toxins produced by micro-organisms eg mycotoxins

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and algal toxins and chemicals added to the commodity by man to control an identified problem eg fungicides or insecticides

Physical contaminants such as broken glass metal fragments insects or stones

The probability that a hazard will occur is called a risk The risk may take a value from zero to one depending on the degree of certainty that the hazard will be absent or that it will be present After hazard identification a hazard analysis must be conducted to understand the relative health risk to man or animal posed by the hazard It is a way of organizing and analyzing the available scientific information on the nature and size of the health risk associated with the hazard The risk may have to be assessed subjectively and simply classified as low medium or high Only those hazards considered by the HACCP team to present an unacceptable risk of being present are taken forward to Stage 7 Principle 2

Once a food safety hazard has been identified then appropriate control measures should be considered These are any action or activity that can be used to control the identified hazard such that it is prevented eliminated or reduced to an acceptable level The control measure may also include training of personnel for a particular operation covered by Good Manufacturing Processes ( GMP)

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

To identify all biological chemical physical and allergen hazards associated with the purchasing delivering storing usage and sale of BLANKrsquos services

Biological Hazards

The following biological hazards were covered by the terms of reference of our HACCP study

1 Yeast amp Moulds2 Coliforms3 E coli4 Listeria5 Salmonella6 Enterobacteriaceae7 Aerobic Mesophile8 Salmonella spp

Chemical Hazards

The following chemical hazards were covered by the terms of reference of our HACCP study

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1 Cleaning residues2 Printing inks lacquers from packaging3 Chemical contaminants and residues in raw materials

Physical Hazards

The following physical hazards were covered by the terms of reference of our HACCP study

1 Metal2 Glass3 Hair4 Wooden splinters5 Dust dirt particles6 Plastic7 Insects

Allergen Hazards

All the following common allergens were considered as part of our HACCP study

1 Milk2 Egg3 Nuts4 Soya5 Gluten6 Crustaceans7 Fish8 Peanuts9 Celery10 Mustard11 Sesame Seeds12 Sulphites13 Lupin14 Molluscs and products thereof

CHEMICALS USED IN FOOD PROCESSINGPoint of use Type of chemicalGrowing crops Pesticides herbicides defoliants Raising livestock Growth hormones antibiotics Production Food additives processing aids Plant maintenance

Lubricants paints solvents

Plant sanitation Cleaners sanitizing agents pesticides

SOME FOOD-BORNE BIOLOGICAL HAZARDS

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Bacteria Parasites Seafood toxinsAeromonas hydrophila

Anisakis spp Ciguatera fish poisoning

Bacillus cereus Ascaris lumbricoides Gempylotoxin Brucella spp Cyclospora

cayetanensisTetrodotoxin

Campylobacter jejuni

Cryptosporidium parvum

Scombrotoxin ( histamine )

Clostridium botulinum

Diphyllobothrium spp Paralytic neurotoxic and

Clostridium perfringens

Entamoeba histolytica Diarrhetic shellfish poisoning

Listeria monocytogenes

Giardia lamblia

Pathogenic Escherichia coli

Taenia spp

Plesiomonas shigelloides

Viruses

Salmonella spp Hepatitis A virusShigella spp Mycotoxigenic moulds PoliovirusesStaphylococcus aureus

Aspergillus spp Norwalk virus group

Streptococcus pyogenes

Fusarium spp

Vibrio cholera Penicillium sppV parahaemolyticusV vulnificusYersinia enterocolitica

EXAMPLES OF PHYSICAL HAZARDS amp THEIR SOURCESPhysical hazard

Source

Metal Bolts nuts screws screens sieves steel woolGlass Light bulbs watch crystals thermometers etcWood splinters Pallets equipment bracing overhead structureInsects Environment electrocution traps incoming ingredients Hair Meat ingredients employees clothing rodentsMould Poor sanitation inadequate cleaning of equipmentRodents droppings

Inadequate rodent controls incoming ingredients

Dirt rocks Raw materials poor employee practices Paint flakes Equipment overhead structureBand-aid Poor employee practicesPen caps Poor employee practicesCarcass ID tags Slaughterhouse

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Hypodermic needles

Veterinarian

Bullets shot BBs

Animals shot while in fields

Feathers Poor sanitation inadequate pest ( bird ) controls Gasket material Inadequate preventive maintenance of equipment Grease Poor equipment maintenance programme

NB Please refer to the generic Hazard Analysis Questionnaire ( under CHECKLISTS ) ndash this checklist is for PER PRODUCT USED

INFO can also be obtained from the productsrsquo MSDS ( MATERIAL SAFETY DATASHEET ) AND OR The Productsrsquo Ingredients Listing

EXAMPLE 1 OF HACCP DECISION TREE

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Q1 Does this step involve a hazard of sufficient likelihood of occurrence and severity to warrant its control

Q3 Is control at this step necessary to prevent eliminate or reduce the risk of hazard to consumers

Modify step process or product

Yes

Is control at this step necessary for safety

Q2 Does a control measure for the hazard exist at this step

Yes

Yes

Yes

No

No

No

No

Not a CCP

This is a critical control point

Not a CCP

Not a CCP

EXAMPLE 2 OF HACCP DECISION TREE

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Q2 Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level

No

Yes

Q1 Do control measure(s) exist for the identified hazard

Modify step process or product

Q4 Will a subsequent step prior to consuming the food eliminate the identified hazard(s) or reduce the likely occurrence to an acceptable level

Q3 Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable level(s)

Yes

Yes

Yes

Yes

No

No

No

Is control at this step necessary for safety

Not a CCP

Not a CCP

This is a critical control point

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

Biological Hazards123456789101112131415

Chemical Hazards123456789101112131415

Physical Hazards12

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 25 of 45 Rev 0

3

456789101112131415

Allergen Hazards123456789101112131415

Stage 7 DETERMINING CRITICAL CONTROL POINT (CCPS) (DECISION TREE)

(Principle 2)

The HACCP team shall determine whether a particular step in the food handling process is a CCP

The method by which a CCP is determined shall be recorder

NOTE The decision tree in annex B can be as a guideline

INTRODUCTION

A Critical Control Point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level

If a hazard has been identified at a step where control is necessary for safety and no control measure exists at that step or any other then the product or process should be modified at that step or at any earlier or later stage to include a control measure

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Determine the Critical Control Points (CCPs)

Each step in the commodity flow diagram within the scope of the HACCP study should be taken in turn and the relevance of each identified hazard should be considered It is also important to remember the stated scope of the HACCP analysis at this stage The team must determine whether the hazard can occur at this step and if so whether control measures exist If the hazard can be controlled adequately and is not best controlled at another step and is essential for food safety then this step is a CCP for the specified hazard A decision tree can be used to determine CCPs However the HACCP teams judgement expertise and knowledge of the process are the major factors in establishing CCPs

If a step is identified where a food safety hazard exists but no adequate control measures can be put in place either at this step or subsequently then the product is unsafe for human consumption Production should cease until control measures are available and a CCP can be introduced

The proper identification of Critical Control Points (CCPs) is crucial to the ultimate effectiveness of a HACCP plan The plan must specify where each identified hazard will be controlled

Hazards that cannot be controlled by the operator must be identified on the HACCP plan The plan must indicate how these hazards will be addressed outside the establishment (ie purchasing pre-frozen fish where the supplier is responsible for the freezing requirements as specified by regulation)

Note The evaluation for completeness of the written CCPs will ensure that all relevant information dealing with critical limits monitoring corrective actions verification procedures and record keeping is specified for each identified hazard

D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S ( C C P S )( C C P S ) (HACCP principle 2)

The determination of a CCP in the HACCP system shall be facilitated using a decision tree ndash as is shown in the following diagram

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 27 of 45 Rev 0

HACCP concept element Application step amp principle

Define the food and the processes involved in production

Break down the process into steps

Determine possible hazards associated with each step and probability of hazard persistence in end product if no affective preventive measures are implemented

Specify control measures

Consequently determine critical control points ( CCPs )

Establish critical limits

Monitor CCPs to ensure proper implementation of control measures

Take corrective action when parameter monitoring indicates failure of control measure

HACCP principles 4 and 5

Application steps 9-10

HACCP principles 2 and 3

Application steps 7-8

HACCP principle 1

Application step 6

Application steps 1-5

System to be reviewed confirmed and audited

Records must be generated for the system to be documented

HACCP principles 6 and 7

Application steps 11-12

Stage 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP (Principle 3)

The HACCP team shall establish specific and measurable critical limits appropriate for each CCP Critical limits that can be measured quickly and easily shall be used Measurements can include sensory examination mass measurements temperature measurements time moisture level PH value and chemical analysis

Records shall be kept

Establish critical limits for each CCP

Critical limits must be specified and validated for each CCP Criteria often used include measurements of temperature time moisture level pH water activity and sensory parameters such as visual appearance In the case of mycotoxins for example they may include the moisture content or the temperature of the commodity All critical limits and the associated permissible tolerances must be documented in the HACCP Plan Worksheet and included as specifications in operating procedures and work instructions

ie Critical limits have to be established for all critical components associated with each hazard that is controlled by a CCP

Critical Limits must meet or exceed relevant regulatory and program requirements Some establishments set critical limits to exceed regulatory requirements This is acceptable but the establishment should be made aware that if these limits are the ones written into the HACCP plan the inspection will be conducted against these more stringent limits

Critical limits normally include measurements such as temperature time moisture level pH aw available chlorine and sensory attributes When applicable compare the critical limits found the establishment HACCP plan to those considered standard industry practice

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For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

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upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

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8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 37 of 45 Rev 0

81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 43 of 45 Rev 0

acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 45 of 45 Rev 0

Page 7: BLANK HACCP STUDY

HACCP Overview

Simply stated Hazard Analysis Critical Control Point (HACCP) is a logical and thorough process control system designed to identify and control hazards HACCP focuses on prevention and control of food safety problems at highly specific (and controllable) points in the process chain Implementing a well-designed HACCP program provides food manufacturers and food handlers a high level of control over product safety

HACCP has been around since the 1960rsquos when the Pillsbury Company introduced it in the production of foods for the space program The application of HACCP is based on sound technical and scientific principles that assure food safety Recently numerous meat and poultry operations have been mandated to utilize HACCP to address concerns with food safety

HACCP plans should be specific for each operation Committed personnel involved in the processing operation should conduct the design and implementation of a HACCP plan

Although many of the larger food establishments and chains have the expertise available to develop and implement HACCP systems some of the smaller establishments may require assistance from university extension programs industry associations consultants and government for development of their plans

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SPECIALIZED PROCESSES amp PROCEDURES REQUIRING A HACCP PLAN

Use of food additives or adding components such as vinegar as a method of food preservation or to render a food so that it is not potentially hazardous Use of unpasteurized whole shell eggs in highly susceptible population (HSP) operations to prepare food in quantities other than single service portions Reduced oxygen packaging (ROP) with barriers

1 Custom processing animals2 Molluscan shellfish tanks3 Smoking for preservation4 Curing5 Time as a public health control6 Preventing contamination from hands

Processes requiring a variance from the State and a formal HACCP plan

bull Smoking food as a method of preservation but not if smoking only forflavor enhancement (using smoking solely for preservation is rarely if ever done)

bull Curing foods such as hams sausages etc

bull Using food additives or adding components such as vinegar as a methodof food preservation or to render a food so that it is not potentially hazardous)

bull Reduced Oxygen Packaging (where CBot is a concern and only one barrier exists)

bull Using more than one container of shellfish at a time (co-mingling)

bull Serving or offering for sale raw or lightly cooked animal foods in a ready-to- eat form (raw eggs raw marinated fish raw molluscan shell fish steak tartar lightly cooked fish soft cooked eggs undercooked meat other than ldquowhole muscle intact beef) and not wanting to use a consumer advisory

bull Molluscan shellfish display tanks that are used to storedisplay shellfish that are offered for human consumption

bull Brewing alcoholic beverages

bull Preparing serving or transporting food by another method that is determined by the HEALTH DEPARTMENT to require a variance or HACCP plan

Processes requiring a variance from the State but no HACCP plan

bull Custom processing of animals or fish for personal use in a licensed food Establishment

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bull Any other requests that vary from the rules of the code where it is determined that a variance is sufficient without a HACCP Plan

Processes requiring a formal HACCP plan and not a variance from the State

bull Pooling of eggs in a food establishment that serves a highly susceptiblepopulation (retirement home nursing home hospital day car etc)

bull Reduced oxygen packaging (where Cbot is a concern and more than one barrier exists) Processes requiring only a written procedure andor approval by the Health Department

bull Using time only as a public health control for potentially hazardous food

bull Use of a two compartment sink for some limited processes

~ A HACCP STUDY - PROCESS FLOW DIAGRAM ~

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Task 1 ASSEMBLY OF OUR HACCP TEAM

821 General

Management shall ensure the establishing of criteria for the selection of team members to assist with the study establishing implementation maintenance and continual improvement of the HACCP system Every team member shall accept in writing his assignment and commitment to the HACCP team

822 The team shall consist of a

a) Team leader

The team leader shall be trained in the requirements as set out in this standard

NOTE The management representative and the team leader may be the same person

b) Team members

The team shall be multi-disciplined and members shall be drawn from each part of the organization likely to be affected for example from production purchasing finance technical engineering quality and distribution The HACCP team shall consist of personnel with specific knowledge of and expertise with regard to the service the food handling process and food safety hazard categories Where appropriate team members with knowledge in the following areas should be considered for inclusion in the team

1) food science

2) microbiology

3) quality control

4) engineering

5) industrial chemistry

6) work studying

7) risk assessment

8) production

9) marketing or sales

10) distribution and

11) food service management

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823 The HACCP team shall establish documentation defining the scope of the HACCP study and the teamrsquos activities The teamrsquos activities should include establishing the following

a) the rules and guidelines for team meetings

b) the criteria used for decision making processes

c) the methodology to be used by the team to determinehazards and CCPs

d) the methodology for reporting on the status of the HACCP system and

e) the methodology for the establishment for procedural requirements orintegration with other relevant management system procedures

824 Where the necessary skills or knowledge are not available within the food handling organization the service of a consultant may be used on condition that the consultant acts only as an expert advisor to the team

Introduction

There are twelve tasks required to develop a HACCP plan and these are designed to ensure that the seven principles are applied correctly Principle 1 which is to conduct a hazard analysis requires that the first five tasks have all been addressed in a logical and honest manner so that all real hazards associated with the commodity have been identified

Establish a HACCP Team

To fully understand the commodity system and be able to identify all likely hazards and CCPs it is important that the HACCP team is made up of people from a wide range of disciplines The team should include

A team leader to convene the group and to direct the work of the team ensuring that the concept is properly applied This person must be familiar with the technique be a good listener and allow all participants to contribute

A specialist with a detailed knowledge of the commodity system is required This specialist will have a major role in the production of the commodity flow diagrams

Several specialists each with an understanding of particular hazards and associated risks eg a microbiologist a chemist a mycotoxicologist a toxicologist a QC manager a process engineer

People such as packaging specialists raw material buyers distribution staff or production staff farmers brokers who are involved with the process and

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have working knowledge of it may be brought into the team temporarily in order to provide relevant expertise

The teams progress and results of the analysis should be recorded by a technical secretary

If any changes are made to composition or operational procedures it will be necessary to re-assess the HACCP plan in the light of the changes

The first activity of the HACCP team is to identify the scope of the study For example will the whole commodity system be covered or only selected components This will make the task more manageable and specialists can be added to the team as and when they are required

Our HACCP TEAMie Who

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Task 2 DESCRIPTION OF OUR SERVICES

A complete description of the service shall be given in terms of type and composition (allergens microbiological chemical and physical properties) relevant legislation handling processing presentation or packaging storage and distribution condition and the shelf life under prescribed conditions

Describe the Product Service

To start a hazard analysis a full description of the product including customer specification should be prepared This should include information relevant to safety eg mycotoxin regulationtarget level composition physicalchemical properties of the raw materials and the final product the amount of water available for microbial growth (aw) the amount of acid or alkali in the product (pH) Also information regarding how the product is to be packaged stored and transported should also be considered together with facts regarding its shelf life and recommended storage temperatures Where appropriate labelling information and an example of the label should be included This information will help the HACCP team to identify real hazards associated with the process

Activity DescriptionFacility Site

Project Coordinator

Activity

Site Manager

Address

Phone

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SERVICES DESCRIPTIONie What Where amp When

Task 3 IDENTIFYING THE INTENDED USE OF OUR SERVICES

The intended use and possible abuse of the service by consumers consumer groups or customers shall be described Attention shall be focused on the likely uses and abuses of the service after it has left the control of the food handling organization Factors such as the vulnerability of the consumer and instructions for use shall be taken into account

Identify the products Services intended use

How the product is intended to be used is an important consideration Information on whether the product will be consumed directly or be cooked or be further processed will all have a bearing on the hazard analysis see task 6) The nature of the target group for the product may also be relevant particularly if it includes susceptible groups such as infants the elderly and the malnourished The likelihood of misuse of a product should also be considered such as the use of pet food as a human food either by accident or design This information can be recorded on the same form as the product description

INTENDED USE OF OUR SERVICEie Why

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Stage 4 CONSTRUCTION OF OUR SERVICE FLOW DIAGRAM

851 The HACCP team shall prepare a detailed floe diagram for the specified food services or process categories relevant to the defined scope of the HACCP study

852 The following should be considered when preparing the flow diagram

a) the selection of raw material

b) processing activities

d) processing delays

e) packaging and storage

f) distribution retail and customer handling of the service

g) any outsourced processes and

h) removal of intermediary services by-services and waste

853 A floor plan relevant to the areas falling within the defined scope of the HACCP study shall be prepared The following should be considered during the preparation of the floor plan as relevant technical data for an effective evaluation of the service flow

a) layout and design features of equipment

b) service flow of liquids powders raw and cooked foods

c) routes of personnel and their personal hygiene practices

d) service recycle or rework loops

e) routes of potential cross-contamination through movement of materials

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(ingredients returns water packaging materials etc)

f) segregation of high risk areas from low risk areas where a risk of cross-contamination exists

g) storage and distribution conditions of the different materials used in thefood handling process

h) packaging materials used and

I) factory hygiene cleaning and disinfection procedures

Draw up the Commodity Flow Diagram ( CFD )

The first function of the team is to draw up a detailed commodity flow diagram (CFD) of the commodity system or that part of it which is relevant The expertise of the commodity specialist is important at this stage Commodity systems will differ in detail in different parts of the world and even within one country there may be a number of variants Secondary processing will need to be detailed for each facility using generic flows only as a guide

BLANK FOOD SERVICES ndash COMMODITY FLOW DIAGRAMie How

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NOTE For your information only ndash two EXAMPLES of FOOD SERVICESrsquo FLOW DIAGRAMS

1

2

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Receiving

Cooking CCP

Cutting Preparation

Frozen Storage

Cooking CCP

Refrigerated Storage

Serving

Thawing

Serving

Hot Holding CCP

Cooling CCP

Consumption

Reheating CCP

Consumption

Serving

Slicing

Consumption

Serving

Slicing

Cooling CCP

Serving

Hot Holding CCP

Stage 5 ON-SITE CONFIRMATION OF THE COMMODITY FLOWDIAGRAM

The HACCP team shall confirm the accuracy of the flow diagram and the floor plan on site during all stages and hours of operation so as to ensure that the flow diagram floor plan and technical data as described in 853 gives an accurate representation of the operation The flow diagram shall be amended to take into account any deviation from the original diagram

Records shall be kept

On site confirmation of flow diagram

Upon completion of the CFD members of the team should visit the commodity system (eg farm store or manufacturing area) to compare the information present on the CFD with what actually happens in practice This is known as walking the line a step by step practice to check that all information regarding materials practices controls etc have been taken into consideration by the team during the preparation of the CFD Information such as time of harvest drying procedures storage conditions the marketing chain socio-economic factors grading systems and any incentive for improved quality or safety and processing systems should be collected and included in the CFD as appropriate The site for which the HACCP plan is being designed should be visited as many times as possible to ensure that all relevant information has been collected

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Stage 6 LISTING OF OUR FOOD SAFETY HAZARDS AND MEASURESTO CONTROL THE HAZARD

(Principle 1)

871 The HACCP team shall use the confirmed flow diagram including all the technical data as a guide to identify all the potential food safety hazards (inherent and introduced) that might reasonably be expected to occur at each step of the food handling process Relevant legislation related to the food safety hazards and their control shall be considered The hazards shall be considered in the light of the significance likelihood and severity of such a hazard in terms of the safety of the consumer

872 Control measures for each identified food safety hazard shall be established in order to control such a hazard More than one hazard and control measure might be applicable to one step in the process and more than one control measure might be necessary to control a particular hazard

873 Records shall be kept

Identify and analyse hazard(s)

Effective hazard identification and hazard analysis are the keys to a successful HACCP Plan All real or potential hazards that may occur in each ingredient and at each stage of the commodity system should be considered Food safety hazards for HACCP programmes have been classified into three types of hazards

Biological typically foodborne bacterial pathogens such as Salmonella Listeria and E coli also viruses algae parasites and fungi

Chemical There are three principle types of chemical toxins found in foods naturally occurring chemicals eg cyanides in some root crops and allergenic compounds in peanuts toxins produced by micro-organisms eg mycotoxins

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and algal toxins and chemicals added to the commodity by man to control an identified problem eg fungicides or insecticides

Physical contaminants such as broken glass metal fragments insects or stones

The probability that a hazard will occur is called a risk The risk may take a value from zero to one depending on the degree of certainty that the hazard will be absent or that it will be present After hazard identification a hazard analysis must be conducted to understand the relative health risk to man or animal posed by the hazard It is a way of organizing and analyzing the available scientific information on the nature and size of the health risk associated with the hazard The risk may have to be assessed subjectively and simply classified as low medium or high Only those hazards considered by the HACCP team to present an unacceptable risk of being present are taken forward to Stage 7 Principle 2

Once a food safety hazard has been identified then appropriate control measures should be considered These are any action or activity that can be used to control the identified hazard such that it is prevented eliminated or reduced to an acceptable level The control measure may also include training of personnel for a particular operation covered by Good Manufacturing Processes ( GMP)

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

To identify all biological chemical physical and allergen hazards associated with the purchasing delivering storing usage and sale of BLANKrsquos services

Biological Hazards

The following biological hazards were covered by the terms of reference of our HACCP study

1 Yeast amp Moulds2 Coliforms3 E coli4 Listeria5 Salmonella6 Enterobacteriaceae7 Aerobic Mesophile8 Salmonella spp

Chemical Hazards

The following chemical hazards were covered by the terms of reference of our HACCP study

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1 Cleaning residues2 Printing inks lacquers from packaging3 Chemical contaminants and residues in raw materials

Physical Hazards

The following physical hazards were covered by the terms of reference of our HACCP study

1 Metal2 Glass3 Hair4 Wooden splinters5 Dust dirt particles6 Plastic7 Insects

Allergen Hazards

All the following common allergens were considered as part of our HACCP study

1 Milk2 Egg3 Nuts4 Soya5 Gluten6 Crustaceans7 Fish8 Peanuts9 Celery10 Mustard11 Sesame Seeds12 Sulphites13 Lupin14 Molluscs and products thereof

CHEMICALS USED IN FOOD PROCESSINGPoint of use Type of chemicalGrowing crops Pesticides herbicides defoliants Raising livestock Growth hormones antibiotics Production Food additives processing aids Plant maintenance

Lubricants paints solvents

Plant sanitation Cleaners sanitizing agents pesticides

SOME FOOD-BORNE BIOLOGICAL HAZARDS

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Bacteria Parasites Seafood toxinsAeromonas hydrophila

Anisakis spp Ciguatera fish poisoning

Bacillus cereus Ascaris lumbricoides Gempylotoxin Brucella spp Cyclospora

cayetanensisTetrodotoxin

Campylobacter jejuni

Cryptosporidium parvum

Scombrotoxin ( histamine )

Clostridium botulinum

Diphyllobothrium spp Paralytic neurotoxic and

Clostridium perfringens

Entamoeba histolytica Diarrhetic shellfish poisoning

Listeria monocytogenes

Giardia lamblia

Pathogenic Escherichia coli

Taenia spp

Plesiomonas shigelloides

Viruses

Salmonella spp Hepatitis A virusShigella spp Mycotoxigenic moulds PoliovirusesStaphylococcus aureus

Aspergillus spp Norwalk virus group

Streptococcus pyogenes

Fusarium spp

Vibrio cholera Penicillium sppV parahaemolyticusV vulnificusYersinia enterocolitica

EXAMPLES OF PHYSICAL HAZARDS amp THEIR SOURCESPhysical hazard

Source

Metal Bolts nuts screws screens sieves steel woolGlass Light bulbs watch crystals thermometers etcWood splinters Pallets equipment bracing overhead structureInsects Environment electrocution traps incoming ingredients Hair Meat ingredients employees clothing rodentsMould Poor sanitation inadequate cleaning of equipmentRodents droppings

Inadequate rodent controls incoming ingredients

Dirt rocks Raw materials poor employee practices Paint flakes Equipment overhead structureBand-aid Poor employee practicesPen caps Poor employee practicesCarcass ID tags Slaughterhouse

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Hypodermic needles

Veterinarian

Bullets shot BBs

Animals shot while in fields

Feathers Poor sanitation inadequate pest ( bird ) controls Gasket material Inadequate preventive maintenance of equipment Grease Poor equipment maintenance programme

NB Please refer to the generic Hazard Analysis Questionnaire ( under CHECKLISTS ) ndash this checklist is for PER PRODUCT USED

INFO can also be obtained from the productsrsquo MSDS ( MATERIAL SAFETY DATASHEET ) AND OR The Productsrsquo Ingredients Listing

EXAMPLE 1 OF HACCP DECISION TREE

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Q1 Does this step involve a hazard of sufficient likelihood of occurrence and severity to warrant its control

Q3 Is control at this step necessary to prevent eliminate or reduce the risk of hazard to consumers

Modify step process or product

Yes

Is control at this step necessary for safety

Q2 Does a control measure for the hazard exist at this step

Yes

Yes

Yes

No

No

No

No

Not a CCP

This is a critical control point

Not a CCP

Not a CCP

EXAMPLE 2 OF HACCP DECISION TREE

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Q2 Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level

No

Yes

Q1 Do control measure(s) exist for the identified hazard

Modify step process or product

Q4 Will a subsequent step prior to consuming the food eliminate the identified hazard(s) or reduce the likely occurrence to an acceptable level

Q3 Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable level(s)

Yes

Yes

Yes

Yes

No

No

No

Is control at this step necessary for safety

Not a CCP

Not a CCP

This is a critical control point

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

Biological Hazards123456789101112131415

Chemical Hazards123456789101112131415

Physical Hazards12

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 25 of 45 Rev 0

3

456789101112131415

Allergen Hazards123456789101112131415

Stage 7 DETERMINING CRITICAL CONTROL POINT (CCPS) (DECISION TREE)

(Principle 2)

The HACCP team shall determine whether a particular step in the food handling process is a CCP

The method by which a CCP is determined shall be recorder

NOTE The decision tree in annex B can be as a guideline

INTRODUCTION

A Critical Control Point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level

If a hazard has been identified at a step where control is necessary for safety and no control measure exists at that step or any other then the product or process should be modified at that step or at any earlier or later stage to include a control measure

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Determine the Critical Control Points (CCPs)

Each step in the commodity flow diagram within the scope of the HACCP study should be taken in turn and the relevance of each identified hazard should be considered It is also important to remember the stated scope of the HACCP analysis at this stage The team must determine whether the hazard can occur at this step and if so whether control measures exist If the hazard can be controlled adequately and is not best controlled at another step and is essential for food safety then this step is a CCP for the specified hazard A decision tree can be used to determine CCPs However the HACCP teams judgement expertise and knowledge of the process are the major factors in establishing CCPs

If a step is identified where a food safety hazard exists but no adequate control measures can be put in place either at this step or subsequently then the product is unsafe for human consumption Production should cease until control measures are available and a CCP can be introduced

The proper identification of Critical Control Points (CCPs) is crucial to the ultimate effectiveness of a HACCP plan The plan must specify where each identified hazard will be controlled

Hazards that cannot be controlled by the operator must be identified on the HACCP plan The plan must indicate how these hazards will be addressed outside the establishment (ie purchasing pre-frozen fish where the supplier is responsible for the freezing requirements as specified by regulation)

Note The evaluation for completeness of the written CCPs will ensure that all relevant information dealing with critical limits monitoring corrective actions verification procedures and record keeping is specified for each identified hazard

D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S ( C C P S )( C C P S ) (HACCP principle 2)

The determination of a CCP in the HACCP system shall be facilitated using a decision tree ndash as is shown in the following diagram

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HACCP concept element Application step amp principle

Define the food and the processes involved in production

Break down the process into steps

Determine possible hazards associated with each step and probability of hazard persistence in end product if no affective preventive measures are implemented

Specify control measures

Consequently determine critical control points ( CCPs )

Establish critical limits

Monitor CCPs to ensure proper implementation of control measures

Take corrective action when parameter monitoring indicates failure of control measure

HACCP principles 4 and 5

Application steps 9-10

HACCP principles 2 and 3

Application steps 7-8

HACCP principle 1

Application step 6

Application steps 1-5

System to be reviewed confirmed and audited

Records must be generated for the system to be documented

HACCP principles 6 and 7

Application steps 11-12

Stage 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP (Principle 3)

The HACCP team shall establish specific and measurable critical limits appropriate for each CCP Critical limits that can be measured quickly and easily shall be used Measurements can include sensory examination mass measurements temperature measurements time moisture level PH value and chemical analysis

Records shall be kept

Establish critical limits for each CCP

Critical limits must be specified and validated for each CCP Criteria often used include measurements of temperature time moisture level pH water activity and sensory parameters such as visual appearance In the case of mycotoxins for example they may include the moisture content or the temperature of the commodity All critical limits and the associated permissible tolerances must be documented in the HACCP Plan Worksheet and included as specifications in operating procedures and work instructions

ie Critical limits have to be established for all critical components associated with each hazard that is controlled by a CCP

Critical Limits must meet or exceed relevant regulatory and program requirements Some establishments set critical limits to exceed regulatory requirements This is acceptable but the establishment should be made aware that if these limits are the ones written into the HACCP plan the inspection will be conducted against these more stringent limits

Critical limits normally include measurements such as temperature time moisture level pH aw available chlorine and sensory attributes When applicable compare the critical limits found the establishment HACCP plan to those considered standard industry practice

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For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

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upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

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8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

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81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

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acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 45 of 45 Rev 0

Page 8: BLANK HACCP STUDY

SPECIALIZED PROCESSES amp PROCEDURES REQUIRING A HACCP PLAN

Use of food additives or adding components such as vinegar as a method of food preservation or to render a food so that it is not potentially hazardous Use of unpasteurized whole shell eggs in highly susceptible population (HSP) operations to prepare food in quantities other than single service portions Reduced oxygen packaging (ROP) with barriers

1 Custom processing animals2 Molluscan shellfish tanks3 Smoking for preservation4 Curing5 Time as a public health control6 Preventing contamination from hands

Processes requiring a variance from the State and a formal HACCP plan

bull Smoking food as a method of preservation but not if smoking only forflavor enhancement (using smoking solely for preservation is rarely if ever done)

bull Curing foods such as hams sausages etc

bull Using food additives or adding components such as vinegar as a methodof food preservation or to render a food so that it is not potentially hazardous)

bull Reduced Oxygen Packaging (where CBot is a concern and only one barrier exists)

bull Using more than one container of shellfish at a time (co-mingling)

bull Serving or offering for sale raw or lightly cooked animal foods in a ready-to- eat form (raw eggs raw marinated fish raw molluscan shell fish steak tartar lightly cooked fish soft cooked eggs undercooked meat other than ldquowhole muscle intact beef) and not wanting to use a consumer advisory

bull Molluscan shellfish display tanks that are used to storedisplay shellfish that are offered for human consumption

bull Brewing alcoholic beverages

bull Preparing serving or transporting food by another method that is determined by the HEALTH DEPARTMENT to require a variance or HACCP plan

Processes requiring a variance from the State but no HACCP plan

bull Custom processing of animals or fish for personal use in a licensed food Establishment

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bull Any other requests that vary from the rules of the code where it is determined that a variance is sufficient without a HACCP Plan

Processes requiring a formal HACCP plan and not a variance from the State

bull Pooling of eggs in a food establishment that serves a highly susceptiblepopulation (retirement home nursing home hospital day car etc)

bull Reduced oxygen packaging (where Cbot is a concern and more than one barrier exists) Processes requiring only a written procedure andor approval by the Health Department

bull Using time only as a public health control for potentially hazardous food

bull Use of a two compartment sink for some limited processes

~ A HACCP STUDY - PROCESS FLOW DIAGRAM ~

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 9 of 45 Rev 0

Task 1 ASSEMBLY OF OUR HACCP TEAM

821 General

Management shall ensure the establishing of criteria for the selection of team members to assist with the study establishing implementation maintenance and continual improvement of the HACCP system Every team member shall accept in writing his assignment and commitment to the HACCP team

822 The team shall consist of a

a) Team leader

The team leader shall be trained in the requirements as set out in this standard

NOTE The management representative and the team leader may be the same person

b) Team members

The team shall be multi-disciplined and members shall be drawn from each part of the organization likely to be affected for example from production purchasing finance technical engineering quality and distribution The HACCP team shall consist of personnel with specific knowledge of and expertise with regard to the service the food handling process and food safety hazard categories Where appropriate team members with knowledge in the following areas should be considered for inclusion in the team

1) food science

2) microbiology

3) quality control

4) engineering

5) industrial chemistry

6) work studying

7) risk assessment

8) production

9) marketing or sales

10) distribution and

11) food service management

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 10 of 45 Rev 0

823 The HACCP team shall establish documentation defining the scope of the HACCP study and the teamrsquos activities The teamrsquos activities should include establishing the following

a) the rules and guidelines for team meetings

b) the criteria used for decision making processes

c) the methodology to be used by the team to determinehazards and CCPs

d) the methodology for reporting on the status of the HACCP system and

e) the methodology for the establishment for procedural requirements orintegration with other relevant management system procedures

824 Where the necessary skills or knowledge are not available within the food handling organization the service of a consultant may be used on condition that the consultant acts only as an expert advisor to the team

Introduction

There are twelve tasks required to develop a HACCP plan and these are designed to ensure that the seven principles are applied correctly Principle 1 which is to conduct a hazard analysis requires that the first five tasks have all been addressed in a logical and honest manner so that all real hazards associated with the commodity have been identified

Establish a HACCP Team

To fully understand the commodity system and be able to identify all likely hazards and CCPs it is important that the HACCP team is made up of people from a wide range of disciplines The team should include

A team leader to convene the group and to direct the work of the team ensuring that the concept is properly applied This person must be familiar with the technique be a good listener and allow all participants to contribute

A specialist with a detailed knowledge of the commodity system is required This specialist will have a major role in the production of the commodity flow diagrams

Several specialists each with an understanding of particular hazards and associated risks eg a microbiologist a chemist a mycotoxicologist a toxicologist a QC manager a process engineer

People such as packaging specialists raw material buyers distribution staff or production staff farmers brokers who are involved with the process and

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 11 of 45 Rev 0

have working knowledge of it may be brought into the team temporarily in order to provide relevant expertise

The teams progress and results of the analysis should be recorded by a technical secretary

If any changes are made to composition or operational procedures it will be necessary to re-assess the HACCP plan in the light of the changes

The first activity of the HACCP team is to identify the scope of the study For example will the whole commodity system be covered or only selected components This will make the task more manageable and specialists can be added to the team as and when they are required

Our HACCP TEAMie Who

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Task 2 DESCRIPTION OF OUR SERVICES

A complete description of the service shall be given in terms of type and composition (allergens microbiological chemical and physical properties) relevant legislation handling processing presentation or packaging storage and distribution condition and the shelf life under prescribed conditions

Describe the Product Service

To start a hazard analysis a full description of the product including customer specification should be prepared This should include information relevant to safety eg mycotoxin regulationtarget level composition physicalchemical properties of the raw materials and the final product the amount of water available for microbial growth (aw) the amount of acid or alkali in the product (pH) Also information regarding how the product is to be packaged stored and transported should also be considered together with facts regarding its shelf life and recommended storage temperatures Where appropriate labelling information and an example of the label should be included This information will help the HACCP team to identify real hazards associated with the process

Activity DescriptionFacility Site

Project Coordinator

Activity

Site Manager

Address

Phone

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 13 of 45 Rev 0

SERVICES DESCRIPTIONie What Where amp When

Task 3 IDENTIFYING THE INTENDED USE OF OUR SERVICES

The intended use and possible abuse of the service by consumers consumer groups or customers shall be described Attention shall be focused on the likely uses and abuses of the service after it has left the control of the food handling organization Factors such as the vulnerability of the consumer and instructions for use shall be taken into account

Identify the products Services intended use

How the product is intended to be used is an important consideration Information on whether the product will be consumed directly or be cooked or be further processed will all have a bearing on the hazard analysis see task 6) The nature of the target group for the product may also be relevant particularly if it includes susceptible groups such as infants the elderly and the malnourished The likelihood of misuse of a product should also be considered such as the use of pet food as a human food either by accident or design This information can be recorded on the same form as the product description

INTENDED USE OF OUR SERVICEie Why

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Stage 4 CONSTRUCTION OF OUR SERVICE FLOW DIAGRAM

851 The HACCP team shall prepare a detailed floe diagram for the specified food services or process categories relevant to the defined scope of the HACCP study

852 The following should be considered when preparing the flow diagram

a) the selection of raw material

b) processing activities

d) processing delays

e) packaging and storage

f) distribution retail and customer handling of the service

g) any outsourced processes and

h) removal of intermediary services by-services and waste

853 A floor plan relevant to the areas falling within the defined scope of the HACCP study shall be prepared The following should be considered during the preparation of the floor plan as relevant technical data for an effective evaluation of the service flow

a) layout and design features of equipment

b) service flow of liquids powders raw and cooked foods

c) routes of personnel and their personal hygiene practices

d) service recycle or rework loops

e) routes of potential cross-contamination through movement of materials

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 15 of 45 Rev 0

(ingredients returns water packaging materials etc)

f) segregation of high risk areas from low risk areas where a risk of cross-contamination exists

g) storage and distribution conditions of the different materials used in thefood handling process

h) packaging materials used and

I) factory hygiene cleaning and disinfection procedures

Draw up the Commodity Flow Diagram ( CFD )

The first function of the team is to draw up a detailed commodity flow diagram (CFD) of the commodity system or that part of it which is relevant The expertise of the commodity specialist is important at this stage Commodity systems will differ in detail in different parts of the world and even within one country there may be a number of variants Secondary processing will need to be detailed for each facility using generic flows only as a guide

BLANK FOOD SERVICES ndash COMMODITY FLOW DIAGRAMie How

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NOTE For your information only ndash two EXAMPLES of FOOD SERVICESrsquo FLOW DIAGRAMS

1

2

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 17 of 45 Rev 0

Receiving

Cooking CCP

Cutting Preparation

Frozen Storage

Cooking CCP

Refrigerated Storage

Serving

Thawing

Serving

Hot Holding CCP

Cooling CCP

Consumption

Reheating CCP

Consumption

Serving

Slicing

Consumption

Serving

Slicing

Cooling CCP

Serving

Hot Holding CCP

Stage 5 ON-SITE CONFIRMATION OF THE COMMODITY FLOWDIAGRAM

The HACCP team shall confirm the accuracy of the flow diagram and the floor plan on site during all stages and hours of operation so as to ensure that the flow diagram floor plan and technical data as described in 853 gives an accurate representation of the operation The flow diagram shall be amended to take into account any deviation from the original diagram

Records shall be kept

On site confirmation of flow diagram

Upon completion of the CFD members of the team should visit the commodity system (eg farm store or manufacturing area) to compare the information present on the CFD with what actually happens in practice This is known as walking the line a step by step practice to check that all information regarding materials practices controls etc have been taken into consideration by the team during the preparation of the CFD Information such as time of harvest drying procedures storage conditions the marketing chain socio-economic factors grading systems and any incentive for improved quality or safety and processing systems should be collected and included in the CFD as appropriate The site for which the HACCP plan is being designed should be visited as many times as possible to ensure that all relevant information has been collected

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Stage 6 LISTING OF OUR FOOD SAFETY HAZARDS AND MEASURESTO CONTROL THE HAZARD

(Principle 1)

871 The HACCP team shall use the confirmed flow diagram including all the technical data as a guide to identify all the potential food safety hazards (inherent and introduced) that might reasonably be expected to occur at each step of the food handling process Relevant legislation related to the food safety hazards and their control shall be considered The hazards shall be considered in the light of the significance likelihood and severity of such a hazard in terms of the safety of the consumer

872 Control measures for each identified food safety hazard shall be established in order to control such a hazard More than one hazard and control measure might be applicable to one step in the process and more than one control measure might be necessary to control a particular hazard

873 Records shall be kept

Identify and analyse hazard(s)

Effective hazard identification and hazard analysis are the keys to a successful HACCP Plan All real or potential hazards that may occur in each ingredient and at each stage of the commodity system should be considered Food safety hazards for HACCP programmes have been classified into three types of hazards

Biological typically foodborne bacterial pathogens such as Salmonella Listeria and E coli also viruses algae parasites and fungi

Chemical There are three principle types of chemical toxins found in foods naturally occurring chemicals eg cyanides in some root crops and allergenic compounds in peanuts toxins produced by micro-organisms eg mycotoxins

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and algal toxins and chemicals added to the commodity by man to control an identified problem eg fungicides or insecticides

Physical contaminants such as broken glass metal fragments insects or stones

The probability that a hazard will occur is called a risk The risk may take a value from zero to one depending on the degree of certainty that the hazard will be absent or that it will be present After hazard identification a hazard analysis must be conducted to understand the relative health risk to man or animal posed by the hazard It is a way of organizing and analyzing the available scientific information on the nature and size of the health risk associated with the hazard The risk may have to be assessed subjectively and simply classified as low medium or high Only those hazards considered by the HACCP team to present an unacceptable risk of being present are taken forward to Stage 7 Principle 2

Once a food safety hazard has been identified then appropriate control measures should be considered These are any action or activity that can be used to control the identified hazard such that it is prevented eliminated or reduced to an acceptable level The control measure may also include training of personnel for a particular operation covered by Good Manufacturing Processes ( GMP)

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

To identify all biological chemical physical and allergen hazards associated with the purchasing delivering storing usage and sale of BLANKrsquos services

Biological Hazards

The following biological hazards were covered by the terms of reference of our HACCP study

1 Yeast amp Moulds2 Coliforms3 E coli4 Listeria5 Salmonella6 Enterobacteriaceae7 Aerobic Mesophile8 Salmonella spp

Chemical Hazards

The following chemical hazards were covered by the terms of reference of our HACCP study

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 20 of 45 Rev 0

1 Cleaning residues2 Printing inks lacquers from packaging3 Chemical contaminants and residues in raw materials

Physical Hazards

The following physical hazards were covered by the terms of reference of our HACCP study

1 Metal2 Glass3 Hair4 Wooden splinters5 Dust dirt particles6 Plastic7 Insects

Allergen Hazards

All the following common allergens were considered as part of our HACCP study

1 Milk2 Egg3 Nuts4 Soya5 Gluten6 Crustaceans7 Fish8 Peanuts9 Celery10 Mustard11 Sesame Seeds12 Sulphites13 Lupin14 Molluscs and products thereof

CHEMICALS USED IN FOOD PROCESSINGPoint of use Type of chemicalGrowing crops Pesticides herbicides defoliants Raising livestock Growth hormones antibiotics Production Food additives processing aids Plant maintenance

Lubricants paints solvents

Plant sanitation Cleaners sanitizing agents pesticides

SOME FOOD-BORNE BIOLOGICAL HAZARDS

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 21 of 45 Rev 0

Bacteria Parasites Seafood toxinsAeromonas hydrophila

Anisakis spp Ciguatera fish poisoning

Bacillus cereus Ascaris lumbricoides Gempylotoxin Brucella spp Cyclospora

cayetanensisTetrodotoxin

Campylobacter jejuni

Cryptosporidium parvum

Scombrotoxin ( histamine )

Clostridium botulinum

Diphyllobothrium spp Paralytic neurotoxic and

Clostridium perfringens

Entamoeba histolytica Diarrhetic shellfish poisoning

Listeria monocytogenes

Giardia lamblia

Pathogenic Escherichia coli

Taenia spp

Plesiomonas shigelloides

Viruses

Salmonella spp Hepatitis A virusShigella spp Mycotoxigenic moulds PoliovirusesStaphylococcus aureus

Aspergillus spp Norwalk virus group

Streptococcus pyogenes

Fusarium spp

Vibrio cholera Penicillium sppV parahaemolyticusV vulnificusYersinia enterocolitica

EXAMPLES OF PHYSICAL HAZARDS amp THEIR SOURCESPhysical hazard

Source

Metal Bolts nuts screws screens sieves steel woolGlass Light bulbs watch crystals thermometers etcWood splinters Pallets equipment bracing overhead structureInsects Environment electrocution traps incoming ingredients Hair Meat ingredients employees clothing rodentsMould Poor sanitation inadequate cleaning of equipmentRodents droppings

Inadequate rodent controls incoming ingredients

Dirt rocks Raw materials poor employee practices Paint flakes Equipment overhead structureBand-aid Poor employee practicesPen caps Poor employee practicesCarcass ID tags Slaughterhouse

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 22 of 45 Rev 0

Hypodermic needles

Veterinarian

Bullets shot BBs

Animals shot while in fields

Feathers Poor sanitation inadequate pest ( bird ) controls Gasket material Inadequate preventive maintenance of equipment Grease Poor equipment maintenance programme

NB Please refer to the generic Hazard Analysis Questionnaire ( under CHECKLISTS ) ndash this checklist is for PER PRODUCT USED

INFO can also be obtained from the productsrsquo MSDS ( MATERIAL SAFETY DATASHEET ) AND OR The Productsrsquo Ingredients Listing

EXAMPLE 1 OF HACCP DECISION TREE

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 23 of 45 Rev 0

Q1 Does this step involve a hazard of sufficient likelihood of occurrence and severity to warrant its control

Q3 Is control at this step necessary to prevent eliminate or reduce the risk of hazard to consumers

Modify step process or product

Yes

Is control at this step necessary for safety

Q2 Does a control measure for the hazard exist at this step

Yes

Yes

Yes

No

No

No

No

Not a CCP

This is a critical control point

Not a CCP

Not a CCP

EXAMPLE 2 OF HACCP DECISION TREE

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Q2 Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level

No

Yes

Q1 Do control measure(s) exist for the identified hazard

Modify step process or product

Q4 Will a subsequent step prior to consuming the food eliminate the identified hazard(s) or reduce the likely occurrence to an acceptable level

Q3 Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable level(s)

Yes

Yes

Yes

Yes

No

No

No

Is control at this step necessary for safety

Not a CCP

Not a CCP

This is a critical control point

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

Biological Hazards123456789101112131415

Chemical Hazards123456789101112131415

Physical Hazards12

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 25 of 45 Rev 0

3

456789101112131415

Allergen Hazards123456789101112131415

Stage 7 DETERMINING CRITICAL CONTROL POINT (CCPS) (DECISION TREE)

(Principle 2)

The HACCP team shall determine whether a particular step in the food handling process is a CCP

The method by which a CCP is determined shall be recorder

NOTE The decision tree in annex B can be as a guideline

INTRODUCTION

A Critical Control Point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level

If a hazard has been identified at a step where control is necessary for safety and no control measure exists at that step or any other then the product or process should be modified at that step or at any earlier or later stage to include a control measure

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 26 of 45 Rev 0

Determine the Critical Control Points (CCPs)

Each step in the commodity flow diagram within the scope of the HACCP study should be taken in turn and the relevance of each identified hazard should be considered It is also important to remember the stated scope of the HACCP analysis at this stage The team must determine whether the hazard can occur at this step and if so whether control measures exist If the hazard can be controlled adequately and is not best controlled at another step and is essential for food safety then this step is a CCP for the specified hazard A decision tree can be used to determine CCPs However the HACCP teams judgement expertise and knowledge of the process are the major factors in establishing CCPs

If a step is identified where a food safety hazard exists but no adequate control measures can be put in place either at this step or subsequently then the product is unsafe for human consumption Production should cease until control measures are available and a CCP can be introduced

The proper identification of Critical Control Points (CCPs) is crucial to the ultimate effectiveness of a HACCP plan The plan must specify where each identified hazard will be controlled

Hazards that cannot be controlled by the operator must be identified on the HACCP plan The plan must indicate how these hazards will be addressed outside the establishment (ie purchasing pre-frozen fish where the supplier is responsible for the freezing requirements as specified by regulation)

Note The evaluation for completeness of the written CCPs will ensure that all relevant information dealing with critical limits monitoring corrective actions verification procedures and record keeping is specified for each identified hazard

D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S ( C C P S )( C C P S ) (HACCP principle 2)

The determination of a CCP in the HACCP system shall be facilitated using a decision tree ndash as is shown in the following diagram

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 27 of 45 Rev 0

HACCP concept element Application step amp principle

Define the food and the processes involved in production

Break down the process into steps

Determine possible hazards associated with each step and probability of hazard persistence in end product if no affective preventive measures are implemented

Specify control measures

Consequently determine critical control points ( CCPs )

Establish critical limits

Monitor CCPs to ensure proper implementation of control measures

Take corrective action when parameter monitoring indicates failure of control measure

HACCP principles 4 and 5

Application steps 9-10

HACCP principles 2 and 3

Application steps 7-8

HACCP principle 1

Application step 6

Application steps 1-5

System to be reviewed confirmed and audited

Records must be generated for the system to be documented

HACCP principles 6 and 7

Application steps 11-12

Stage 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP (Principle 3)

The HACCP team shall establish specific and measurable critical limits appropriate for each CCP Critical limits that can be measured quickly and easily shall be used Measurements can include sensory examination mass measurements temperature measurements time moisture level PH value and chemical analysis

Records shall be kept

Establish critical limits for each CCP

Critical limits must be specified and validated for each CCP Criteria often used include measurements of temperature time moisture level pH water activity and sensory parameters such as visual appearance In the case of mycotoxins for example they may include the moisture content or the temperature of the commodity All critical limits and the associated permissible tolerances must be documented in the HACCP Plan Worksheet and included as specifications in operating procedures and work instructions

ie Critical limits have to be established for all critical components associated with each hazard that is controlled by a CCP

Critical Limits must meet or exceed relevant regulatory and program requirements Some establishments set critical limits to exceed regulatory requirements This is acceptable but the establishment should be made aware that if these limits are the ones written into the HACCP plan the inspection will be conducted against these more stringent limits

Critical limits normally include measurements such as temperature time moisture level pH aw available chlorine and sensory attributes When applicable compare the critical limits found the establishment HACCP plan to those considered standard industry practice

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 28 of 45 Rev 0

For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 29 of 45 Rev 0

upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 30 of 45 Rev 0

8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 31 of 45 Rev 0

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 32 of 45 Rev 0

Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

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81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

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acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

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Page 9: BLANK HACCP STUDY

bull Any other requests that vary from the rules of the code where it is determined that a variance is sufficient without a HACCP Plan

Processes requiring a formal HACCP plan and not a variance from the State

bull Pooling of eggs in a food establishment that serves a highly susceptiblepopulation (retirement home nursing home hospital day car etc)

bull Reduced oxygen packaging (where Cbot is a concern and more than one barrier exists) Processes requiring only a written procedure andor approval by the Health Department

bull Using time only as a public health control for potentially hazardous food

bull Use of a two compartment sink for some limited processes

~ A HACCP STUDY - PROCESS FLOW DIAGRAM ~

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Task 1 ASSEMBLY OF OUR HACCP TEAM

821 General

Management shall ensure the establishing of criteria for the selection of team members to assist with the study establishing implementation maintenance and continual improvement of the HACCP system Every team member shall accept in writing his assignment and commitment to the HACCP team

822 The team shall consist of a

a) Team leader

The team leader shall be trained in the requirements as set out in this standard

NOTE The management representative and the team leader may be the same person

b) Team members

The team shall be multi-disciplined and members shall be drawn from each part of the organization likely to be affected for example from production purchasing finance technical engineering quality and distribution The HACCP team shall consist of personnel with specific knowledge of and expertise with regard to the service the food handling process and food safety hazard categories Where appropriate team members with knowledge in the following areas should be considered for inclusion in the team

1) food science

2) microbiology

3) quality control

4) engineering

5) industrial chemistry

6) work studying

7) risk assessment

8) production

9) marketing or sales

10) distribution and

11) food service management

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823 The HACCP team shall establish documentation defining the scope of the HACCP study and the teamrsquos activities The teamrsquos activities should include establishing the following

a) the rules and guidelines for team meetings

b) the criteria used for decision making processes

c) the methodology to be used by the team to determinehazards and CCPs

d) the methodology for reporting on the status of the HACCP system and

e) the methodology for the establishment for procedural requirements orintegration with other relevant management system procedures

824 Where the necessary skills or knowledge are not available within the food handling organization the service of a consultant may be used on condition that the consultant acts only as an expert advisor to the team

Introduction

There are twelve tasks required to develop a HACCP plan and these are designed to ensure that the seven principles are applied correctly Principle 1 which is to conduct a hazard analysis requires that the first five tasks have all been addressed in a logical and honest manner so that all real hazards associated with the commodity have been identified

Establish a HACCP Team

To fully understand the commodity system and be able to identify all likely hazards and CCPs it is important that the HACCP team is made up of people from a wide range of disciplines The team should include

A team leader to convene the group and to direct the work of the team ensuring that the concept is properly applied This person must be familiar with the technique be a good listener and allow all participants to contribute

A specialist with a detailed knowledge of the commodity system is required This specialist will have a major role in the production of the commodity flow diagrams

Several specialists each with an understanding of particular hazards and associated risks eg a microbiologist a chemist a mycotoxicologist a toxicologist a QC manager a process engineer

People such as packaging specialists raw material buyers distribution staff or production staff farmers brokers who are involved with the process and

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have working knowledge of it may be brought into the team temporarily in order to provide relevant expertise

The teams progress and results of the analysis should be recorded by a technical secretary

If any changes are made to composition or operational procedures it will be necessary to re-assess the HACCP plan in the light of the changes

The first activity of the HACCP team is to identify the scope of the study For example will the whole commodity system be covered or only selected components This will make the task more manageable and specialists can be added to the team as and when they are required

Our HACCP TEAMie Who

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Task 2 DESCRIPTION OF OUR SERVICES

A complete description of the service shall be given in terms of type and composition (allergens microbiological chemical and physical properties) relevant legislation handling processing presentation or packaging storage and distribution condition and the shelf life under prescribed conditions

Describe the Product Service

To start a hazard analysis a full description of the product including customer specification should be prepared This should include information relevant to safety eg mycotoxin regulationtarget level composition physicalchemical properties of the raw materials and the final product the amount of water available for microbial growth (aw) the amount of acid or alkali in the product (pH) Also information regarding how the product is to be packaged stored and transported should also be considered together with facts regarding its shelf life and recommended storage temperatures Where appropriate labelling information and an example of the label should be included This information will help the HACCP team to identify real hazards associated with the process

Activity DescriptionFacility Site

Project Coordinator

Activity

Site Manager

Address

Phone

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SERVICES DESCRIPTIONie What Where amp When

Task 3 IDENTIFYING THE INTENDED USE OF OUR SERVICES

The intended use and possible abuse of the service by consumers consumer groups or customers shall be described Attention shall be focused on the likely uses and abuses of the service after it has left the control of the food handling organization Factors such as the vulnerability of the consumer and instructions for use shall be taken into account

Identify the products Services intended use

How the product is intended to be used is an important consideration Information on whether the product will be consumed directly or be cooked or be further processed will all have a bearing on the hazard analysis see task 6) The nature of the target group for the product may also be relevant particularly if it includes susceptible groups such as infants the elderly and the malnourished The likelihood of misuse of a product should also be considered such as the use of pet food as a human food either by accident or design This information can be recorded on the same form as the product description

INTENDED USE OF OUR SERVICEie Why

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Stage 4 CONSTRUCTION OF OUR SERVICE FLOW DIAGRAM

851 The HACCP team shall prepare a detailed floe diagram for the specified food services or process categories relevant to the defined scope of the HACCP study

852 The following should be considered when preparing the flow diagram

a) the selection of raw material

b) processing activities

d) processing delays

e) packaging and storage

f) distribution retail and customer handling of the service

g) any outsourced processes and

h) removal of intermediary services by-services and waste

853 A floor plan relevant to the areas falling within the defined scope of the HACCP study shall be prepared The following should be considered during the preparation of the floor plan as relevant technical data for an effective evaluation of the service flow

a) layout and design features of equipment

b) service flow of liquids powders raw and cooked foods

c) routes of personnel and their personal hygiene practices

d) service recycle or rework loops

e) routes of potential cross-contamination through movement of materials

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(ingredients returns water packaging materials etc)

f) segregation of high risk areas from low risk areas where a risk of cross-contamination exists

g) storage and distribution conditions of the different materials used in thefood handling process

h) packaging materials used and

I) factory hygiene cleaning and disinfection procedures

Draw up the Commodity Flow Diagram ( CFD )

The first function of the team is to draw up a detailed commodity flow diagram (CFD) of the commodity system or that part of it which is relevant The expertise of the commodity specialist is important at this stage Commodity systems will differ in detail in different parts of the world and even within one country there may be a number of variants Secondary processing will need to be detailed for each facility using generic flows only as a guide

BLANK FOOD SERVICES ndash COMMODITY FLOW DIAGRAMie How

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NOTE For your information only ndash two EXAMPLES of FOOD SERVICESrsquo FLOW DIAGRAMS

1

2

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Receiving

Cooking CCP

Cutting Preparation

Frozen Storage

Cooking CCP

Refrigerated Storage

Serving

Thawing

Serving

Hot Holding CCP

Cooling CCP

Consumption

Reheating CCP

Consumption

Serving

Slicing

Consumption

Serving

Slicing

Cooling CCP

Serving

Hot Holding CCP

Stage 5 ON-SITE CONFIRMATION OF THE COMMODITY FLOWDIAGRAM

The HACCP team shall confirm the accuracy of the flow diagram and the floor plan on site during all stages and hours of operation so as to ensure that the flow diagram floor plan and technical data as described in 853 gives an accurate representation of the operation The flow diagram shall be amended to take into account any deviation from the original diagram

Records shall be kept

On site confirmation of flow diagram

Upon completion of the CFD members of the team should visit the commodity system (eg farm store or manufacturing area) to compare the information present on the CFD with what actually happens in practice This is known as walking the line a step by step practice to check that all information regarding materials practices controls etc have been taken into consideration by the team during the preparation of the CFD Information such as time of harvest drying procedures storage conditions the marketing chain socio-economic factors grading systems and any incentive for improved quality or safety and processing systems should be collected and included in the CFD as appropriate The site for which the HACCP plan is being designed should be visited as many times as possible to ensure that all relevant information has been collected

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Stage 6 LISTING OF OUR FOOD SAFETY HAZARDS AND MEASURESTO CONTROL THE HAZARD

(Principle 1)

871 The HACCP team shall use the confirmed flow diagram including all the technical data as a guide to identify all the potential food safety hazards (inherent and introduced) that might reasonably be expected to occur at each step of the food handling process Relevant legislation related to the food safety hazards and their control shall be considered The hazards shall be considered in the light of the significance likelihood and severity of such a hazard in terms of the safety of the consumer

872 Control measures for each identified food safety hazard shall be established in order to control such a hazard More than one hazard and control measure might be applicable to one step in the process and more than one control measure might be necessary to control a particular hazard

873 Records shall be kept

Identify and analyse hazard(s)

Effective hazard identification and hazard analysis are the keys to a successful HACCP Plan All real or potential hazards that may occur in each ingredient and at each stage of the commodity system should be considered Food safety hazards for HACCP programmes have been classified into three types of hazards

Biological typically foodborne bacterial pathogens such as Salmonella Listeria and E coli also viruses algae parasites and fungi

Chemical There are three principle types of chemical toxins found in foods naturally occurring chemicals eg cyanides in some root crops and allergenic compounds in peanuts toxins produced by micro-organisms eg mycotoxins

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and algal toxins and chemicals added to the commodity by man to control an identified problem eg fungicides or insecticides

Physical contaminants such as broken glass metal fragments insects or stones

The probability that a hazard will occur is called a risk The risk may take a value from zero to one depending on the degree of certainty that the hazard will be absent or that it will be present After hazard identification a hazard analysis must be conducted to understand the relative health risk to man or animal posed by the hazard It is a way of organizing and analyzing the available scientific information on the nature and size of the health risk associated with the hazard The risk may have to be assessed subjectively and simply classified as low medium or high Only those hazards considered by the HACCP team to present an unacceptable risk of being present are taken forward to Stage 7 Principle 2

Once a food safety hazard has been identified then appropriate control measures should be considered These are any action or activity that can be used to control the identified hazard such that it is prevented eliminated or reduced to an acceptable level The control measure may also include training of personnel for a particular operation covered by Good Manufacturing Processes ( GMP)

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

To identify all biological chemical physical and allergen hazards associated with the purchasing delivering storing usage and sale of BLANKrsquos services

Biological Hazards

The following biological hazards were covered by the terms of reference of our HACCP study

1 Yeast amp Moulds2 Coliforms3 E coli4 Listeria5 Salmonella6 Enterobacteriaceae7 Aerobic Mesophile8 Salmonella spp

Chemical Hazards

The following chemical hazards were covered by the terms of reference of our HACCP study

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1 Cleaning residues2 Printing inks lacquers from packaging3 Chemical contaminants and residues in raw materials

Physical Hazards

The following physical hazards were covered by the terms of reference of our HACCP study

1 Metal2 Glass3 Hair4 Wooden splinters5 Dust dirt particles6 Plastic7 Insects

Allergen Hazards

All the following common allergens were considered as part of our HACCP study

1 Milk2 Egg3 Nuts4 Soya5 Gluten6 Crustaceans7 Fish8 Peanuts9 Celery10 Mustard11 Sesame Seeds12 Sulphites13 Lupin14 Molluscs and products thereof

CHEMICALS USED IN FOOD PROCESSINGPoint of use Type of chemicalGrowing crops Pesticides herbicides defoliants Raising livestock Growth hormones antibiotics Production Food additives processing aids Plant maintenance

Lubricants paints solvents

Plant sanitation Cleaners sanitizing agents pesticides

SOME FOOD-BORNE BIOLOGICAL HAZARDS

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Bacteria Parasites Seafood toxinsAeromonas hydrophila

Anisakis spp Ciguatera fish poisoning

Bacillus cereus Ascaris lumbricoides Gempylotoxin Brucella spp Cyclospora

cayetanensisTetrodotoxin

Campylobacter jejuni

Cryptosporidium parvum

Scombrotoxin ( histamine )

Clostridium botulinum

Diphyllobothrium spp Paralytic neurotoxic and

Clostridium perfringens

Entamoeba histolytica Diarrhetic shellfish poisoning

Listeria monocytogenes

Giardia lamblia

Pathogenic Escherichia coli

Taenia spp

Plesiomonas shigelloides

Viruses

Salmonella spp Hepatitis A virusShigella spp Mycotoxigenic moulds PoliovirusesStaphylococcus aureus

Aspergillus spp Norwalk virus group

Streptococcus pyogenes

Fusarium spp

Vibrio cholera Penicillium sppV parahaemolyticusV vulnificusYersinia enterocolitica

EXAMPLES OF PHYSICAL HAZARDS amp THEIR SOURCESPhysical hazard

Source

Metal Bolts nuts screws screens sieves steel woolGlass Light bulbs watch crystals thermometers etcWood splinters Pallets equipment bracing overhead structureInsects Environment electrocution traps incoming ingredients Hair Meat ingredients employees clothing rodentsMould Poor sanitation inadequate cleaning of equipmentRodents droppings

Inadequate rodent controls incoming ingredients

Dirt rocks Raw materials poor employee practices Paint flakes Equipment overhead structureBand-aid Poor employee practicesPen caps Poor employee practicesCarcass ID tags Slaughterhouse

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Hypodermic needles

Veterinarian

Bullets shot BBs

Animals shot while in fields

Feathers Poor sanitation inadequate pest ( bird ) controls Gasket material Inadequate preventive maintenance of equipment Grease Poor equipment maintenance programme

NB Please refer to the generic Hazard Analysis Questionnaire ( under CHECKLISTS ) ndash this checklist is for PER PRODUCT USED

INFO can also be obtained from the productsrsquo MSDS ( MATERIAL SAFETY DATASHEET ) AND OR The Productsrsquo Ingredients Listing

EXAMPLE 1 OF HACCP DECISION TREE

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Q1 Does this step involve a hazard of sufficient likelihood of occurrence and severity to warrant its control

Q3 Is control at this step necessary to prevent eliminate or reduce the risk of hazard to consumers

Modify step process or product

Yes

Is control at this step necessary for safety

Q2 Does a control measure for the hazard exist at this step

Yes

Yes

Yes

No

No

No

No

Not a CCP

This is a critical control point

Not a CCP

Not a CCP

EXAMPLE 2 OF HACCP DECISION TREE

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Q2 Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level

No

Yes

Q1 Do control measure(s) exist for the identified hazard

Modify step process or product

Q4 Will a subsequent step prior to consuming the food eliminate the identified hazard(s) or reduce the likely occurrence to an acceptable level

Q3 Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable level(s)

Yes

Yes

Yes

Yes

No

No

No

Is control at this step necessary for safety

Not a CCP

Not a CCP

This is a critical control point

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

Biological Hazards123456789101112131415

Chemical Hazards123456789101112131415

Physical Hazards12

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3

456789101112131415

Allergen Hazards123456789101112131415

Stage 7 DETERMINING CRITICAL CONTROL POINT (CCPS) (DECISION TREE)

(Principle 2)

The HACCP team shall determine whether a particular step in the food handling process is a CCP

The method by which a CCP is determined shall be recorder

NOTE The decision tree in annex B can be as a guideline

INTRODUCTION

A Critical Control Point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level

If a hazard has been identified at a step where control is necessary for safety and no control measure exists at that step or any other then the product or process should be modified at that step or at any earlier or later stage to include a control measure

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Determine the Critical Control Points (CCPs)

Each step in the commodity flow diagram within the scope of the HACCP study should be taken in turn and the relevance of each identified hazard should be considered It is also important to remember the stated scope of the HACCP analysis at this stage The team must determine whether the hazard can occur at this step and if so whether control measures exist If the hazard can be controlled adequately and is not best controlled at another step and is essential for food safety then this step is a CCP for the specified hazard A decision tree can be used to determine CCPs However the HACCP teams judgement expertise and knowledge of the process are the major factors in establishing CCPs

If a step is identified where a food safety hazard exists but no adequate control measures can be put in place either at this step or subsequently then the product is unsafe for human consumption Production should cease until control measures are available and a CCP can be introduced

The proper identification of Critical Control Points (CCPs) is crucial to the ultimate effectiveness of a HACCP plan The plan must specify where each identified hazard will be controlled

Hazards that cannot be controlled by the operator must be identified on the HACCP plan The plan must indicate how these hazards will be addressed outside the establishment (ie purchasing pre-frozen fish where the supplier is responsible for the freezing requirements as specified by regulation)

Note The evaluation for completeness of the written CCPs will ensure that all relevant information dealing with critical limits monitoring corrective actions verification procedures and record keeping is specified for each identified hazard

D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S ( C C P S )( C C P S ) (HACCP principle 2)

The determination of a CCP in the HACCP system shall be facilitated using a decision tree ndash as is shown in the following diagram

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HACCP concept element Application step amp principle

Define the food and the processes involved in production

Break down the process into steps

Determine possible hazards associated with each step and probability of hazard persistence in end product if no affective preventive measures are implemented

Specify control measures

Consequently determine critical control points ( CCPs )

Establish critical limits

Monitor CCPs to ensure proper implementation of control measures

Take corrective action when parameter monitoring indicates failure of control measure

HACCP principles 4 and 5

Application steps 9-10

HACCP principles 2 and 3

Application steps 7-8

HACCP principle 1

Application step 6

Application steps 1-5

System to be reviewed confirmed and audited

Records must be generated for the system to be documented

HACCP principles 6 and 7

Application steps 11-12

Stage 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP (Principle 3)

The HACCP team shall establish specific and measurable critical limits appropriate for each CCP Critical limits that can be measured quickly and easily shall be used Measurements can include sensory examination mass measurements temperature measurements time moisture level PH value and chemical analysis

Records shall be kept

Establish critical limits for each CCP

Critical limits must be specified and validated for each CCP Criteria often used include measurements of temperature time moisture level pH water activity and sensory parameters such as visual appearance In the case of mycotoxins for example they may include the moisture content or the temperature of the commodity All critical limits and the associated permissible tolerances must be documented in the HACCP Plan Worksheet and included as specifications in operating procedures and work instructions

ie Critical limits have to be established for all critical components associated with each hazard that is controlled by a CCP

Critical Limits must meet or exceed relevant regulatory and program requirements Some establishments set critical limits to exceed regulatory requirements This is acceptable but the establishment should be made aware that if these limits are the ones written into the HACCP plan the inspection will be conducted against these more stringent limits

Critical limits normally include measurements such as temperature time moisture level pH aw available chlorine and sensory attributes When applicable compare the critical limits found the establishment HACCP plan to those considered standard industry practice

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For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

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upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

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8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

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81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 43 of 45 Rev 0

acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 45 of 45 Rev 0

Page 10: BLANK HACCP STUDY

Task 1 ASSEMBLY OF OUR HACCP TEAM

821 General

Management shall ensure the establishing of criteria for the selection of team members to assist with the study establishing implementation maintenance and continual improvement of the HACCP system Every team member shall accept in writing his assignment and commitment to the HACCP team

822 The team shall consist of a

a) Team leader

The team leader shall be trained in the requirements as set out in this standard

NOTE The management representative and the team leader may be the same person

b) Team members

The team shall be multi-disciplined and members shall be drawn from each part of the organization likely to be affected for example from production purchasing finance technical engineering quality and distribution The HACCP team shall consist of personnel with specific knowledge of and expertise with regard to the service the food handling process and food safety hazard categories Where appropriate team members with knowledge in the following areas should be considered for inclusion in the team

1) food science

2) microbiology

3) quality control

4) engineering

5) industrial chemistry

6) work studying

7) risk assessment

8) production

9) marketing or sales

10) distribution and

11) food service management

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823 The HACCP team shall establish documentation defining the scope of the HACCP study and the teamrsquos activities The teamrsquos activities should include establishing the following

a) the rules and guidelines for team meetings

b) the criteria used for decision making processes

c) the methodology to be used by the team to determinehazards and CCPs

d) the methodology for reporting on the status of the HACCP system and

e) the methodology for the establishment for procedural requirements orintegration with other relevant management system procedures

824 Where the necessary skills or knowledge are not available within the food handling organization the service of a consultant may be used on condition that the consultant acts only as an expert advisor to the team

Introduction

There are twelve tasks required to develop a HACCP plan and these are designed to ensure that the seven principles are applied correctly Principle 1 which is to conduct a hazard analysis requires that the first five tasks have all been addressed in a logical and honest manner so that all real hazards associated with the commodity have been identified

Establish a HACCP Team

To fully understand the commodity system and be able to identify all likely hazards and CCPs it is important that the HACCP team is made up of people from a wide range of disciplines The team should include

A team leader to convene the group and to direct the work of the team ensuring that the concept is properly applied This person must be familiar with the technique be a good listener and allow all participants to contribute

A specialist with a detailed knowledge of the commodity system is required This specialist will have a major role in the production of the commodity flow diagrams

Several specialists each with an understanding of particular hazards and associated risks eg a microbiologist a chemist a mycotoxicologist a toxicologist a QC manager a process engineer

People such as packaging specialists raw material buyers distribution staff or production staff farmers brokers who are involved with the process and

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 11 of 45 Rev 0

have working knowledge of it may be brought into the team temporarily in order to provide relevant expertise

The teams progress and results of the analysis should be recorded by a technical secretary

If any changes are made to composition or operational procedures it will be necessary to re-assess the HACCP plan in the light of the changes

The first activity of the HACCP team is to identify the scope of the study For example will the whole commodity system be covered or only selected components This will make the task more manageable and specialists can be added to the team as and when they are required

Our HACCP TEAMie Who

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Task 2 DESCRIPTION OF OUR SERVICES

A complete description of the service shall be given in terms of type and composition (allergens microbiological chemical and physical properties) relevant legislation handling processing presentation or packaging storage and distribution condition and the shelf life under prescribed conditions

Describe the Product Service

To start a hazard analysis a full description of the product including customer specification should be prepared This should include information relevant to safety eg mycotoxin regulationtarget level composition physicalchemical properties of the raw materials and the final product the amount of water available for microbial growth (aw) the amount of acid or alkali in the product (pH) Also information regarding how the product is to be packaged stored and transported should also be considered together with facts regarding its shelf life and recommended storage temperatures Where appropriate labelling information and an example of the label should be included This information will help the HACCP team to identify real hazards associated with the process

Activity DescriptionFacility Site

Project Coordinator

Activity

Site Manager

Address

Phone

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SERVICES DESCRIPTIONie What Where amp When

Task 3 IDENTIFYING THE INTENDED USE OF OUR SERVICES

The intended use and possible abuse of the service by consumers consumer groups or customers shall be described Attention shall be focused on the likely uses and abuses of the service after it has left the control of the food handling organization Factors such as the vulnerability of the consumer and instructions for use shall be taken into account

Identify the products Services intended use

How the product is intended to be used is an important consideration Information on whether the product will be consumed directly or be cooked or be further processed will all have a bearing on the hazard analysis see task 6) The nature of the target group for the product may also be relevant particularly if it includes susceptible groups such as infants the elderly and the malnourished The likelihood of misuse of a product should also be considered such as the use of pet food as a human food either by accident or design This information can be recorded on the same form as the product description

INTENDED USE OF OUR SERVICEie Why

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Stage 4 CONSTRUCTION OF OUR SERVICE FLOW DIAGRAM

851 The HACCP team shall prepare a detailed floe diagram for the specified food services or process categories relevant to the defined scope of the HACCP study

852 The following should be considered when preparing the flow diagram

a) the selection of raw material

b) processing activities

d) processing delays

e) packaging and storage

f) distribution retail and customer handling of the service

g) any outsourced processes and

h) removal of intermediary services by-services and waste

853 A floor plan relevant to the areas falling within the defined scope of the HACCP study shall be prepared The following should be considered during the preparation of the floor plan as relevant technical data for an effective evaluation of the service flow

a) layout and design features of equipment

b) service flow of liquids powders raw and cooked foods

c) routes of personnel and their personal hygiene practices

d) service recycle or rework loops

e) routes of potential cross-contamination through movement of materials

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(ingredients returns water packaging materials etc)

f) segregation of high risk areas from low risk areas where a risk of cross-contamination exists

g) storage and distribution conditions of the different materials used in thefood handling process

h) packaging materials used and

I) factory hygiene cleaning and disinfection procedures

Draw up the Commodity Flow Diagram ( CFD )

The first function of the team is to draw up a detailed commodity flow diagram (CFD) of the commodity system or that part of it which is relevant The expertise of the commodity specialist is important at this stage Commodity systems will differ in detail in different parts of the world and even within one country there may be a number of variants Secondary processing will need to be detailed for each facility using generic flows only as a guide

BLANK FOOD SERVICES ndash COMMODITY FLOW DIAGRAMie How

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NOTE For your information only ndash two EXAMPLES of FOOD SERVICESrsquo FLOW DIAGRAMS

1

2

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 17 of 45 Rev 0

Receiving

Cooking CCP

Cutting Preparation

Frozen Storage

Cooking CCP

Refrigerated Storage

Serving

Thawing

Serving

Hot Holding CCP

Cooling CCP

Consumption

Reheating CCP

Consumption

Serving

Slicing

Consumption

Serving

Slicing

Cooling CCP

Serving

Hot Holding CCP

Stage 5 ON-SITE CONFIRMATION OF THE COMMODITY FLOWDIAGRAM

The HACCP team shall confirm the accuracy of the flow diagram and the floor plan on site during all stages and hours of operation so as to ensure that the flow diagram floor plan and technical data as described in 853 gives an accurate representation of the operation The flow diagram shall be amended to take into account any deviation from the original diagram

Records shall be kept

On site confirmation of flow diagram

Upon completion of the CFD members of the team should visit the commodity system (eg farm store or manufacturing area) to compare the information present on the CFD with what actually happens in practice This is known as walking the line a step by step practice to check that all information regarding materials practices controls etc have been taken into consideration by the team during the preparation of the CFD Information such as time of harvest drying procedures storage conditions the marketing chain socio-economic factors grading systems and any incentive for improved quality or safety and processing systems should be collected and included in the CFD as appropriate The site for which the HACCP plan is being designed should be visited as many times as possible to ensure that all relevant information has been collected

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Stage 6 LISTING OF OUR FOOD SAFETY HAZARDS AND MEASURESTO CONTROL THE HAZARD

(Principle 1)

871 The HACCP team shall use the confirmed flow diagram including all the technical data as a guide to identify all the potential food safety hazards (inherent and introduced) that might reasonably be expected to occur at each step of the food handling process Relevant legislation related to the food safety hazards and their control shall be considered The hazards shall be considered in the light of the significance likelihood and severity of such a hazard in terms of the safety of the consumer

872 Control measures for each identified food safety hazard shall be established in order to control such a hazard More than one hazard and control measure might be applicable to one step in the process and more than one control measure might be necessary to control a particular hazard

873 Records shall be kept

Identify and analyse hazard(s)

Effective hazard identification and hazard analysis are the keys to a successful HACCP Plan All real or potential hazards that may occur in each ingredient and at each stage of the commodity system should be considered Food safety hazards for HACCP programmes have been classified into three types of hazards

Biological typically foodborne bacterial pathogens such as Salmonella Listeria and E coli also viruses algae parasites and fungi

Chemical There are three principle types of chemical toxins found in foods naturally occurring chemicals eg cyanides in some root crops and allergenic compounds in peanuts toxins produced by micro-organisms eg mycotoxins

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and algal toxins and chemicals added to the commodity by man to control an identified problem eg fungicides or insecticides

Physical contaminants such as broken glass metal fragments insects or stones

The probability that a hazard will occur is called a risk The risk may take a value from zero to one depending on the degree of certainty that the hazard will be absent or that it will be present After hazard identification a hazard analysis must be conducted to understand the relative health risk to man or animal posed by the hazard It is a way of organizing and analyzing the available scientific information on the nature and size of the health risk associated with the hazard The risk may have to be assessed subjectively and simply classified as low medium or high Only those hazards considered by the HACCP team to present an unacceptable risk of being present are taken forward to Stage 7 Principle 2

Once a food safety hazard has been identified then appropriate control measures should be considered These are any action or activity that can be used to control the identified hazard such that it is prevented eliminated or reduced to an acceptable level The control measure may also include training of personnel for a particular operation covered by Good Manufacturing Processes ( GMP)

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

To identify all biological chemical physical and allergen hazards associated with the purchasing delivering storing usage and sale of BLANKrsquos services

Biological Hazards

The following biological hazards were covered by the terms of reference of our HACCP study

1 Yeast amp Moulds2 Coliforms3 E coli4 Listeria5 Salmonella6 Enterobacteriaceae7 Aerobic Mesophile8 Salmonella spp

Chemical Hazards

The following chemical hazards were covered by the terms of reference of our HACCP study

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1 Cleaning residues2 Printing inks lacquers from packaging3 Chemical contaminants and residues in raw materials

Physical Hazards

The following physical hazards were covered by the terms of reference of our HACCP study

1 Metal2 Glass3 Hair4 Wooden splinters5 Dust dirt particles6 Plastic7 Insects

Allergen Hazards

All the following common allergens were considered as part of our HACCP study

1 Milk2 Egg3 Nuts4 Soya5 Gluten6 Crustaceans7 Fish8 Peanuts9 Celery10 Mustard11 Sesame Seeds12 Sulphites13 Lupin14 Molluscs and products thereof

CHEMICALS USED IN FOOD PROCESSINGPoint of use Type of chemicalGrowing crops Pesticides herbicides defoliants Raising livestock Growth hormones antibiotics Production Food additives processing aids Plant maintenance

Lubricants paints solvents

Plant sanitation Cleaners sanitizing agents pesticides

SOME FOOD-BORNE BIOLOGICAL HAZARDS

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Bacteria Parasites Seafood toxinsAeromonas hydrophila

Anisakis spp Ciguatera fish poisoning

Bacillus cereus Ascaris lumbricoides Gempylotoxin Brucella spp Cyclospora

cayetanensisTetrodotoxin

Campylobacter jejuni

Cryptosporidium parvum

Scombrotoxin ( histamine )

Clostridium botulinum

Diphyllobothrium spp Paralytic neurotoxic and

Clostridium perfringens

Entamoeba histolytica Diarrhetic shellfish poisoning

Listeria monocytogenes

Giardia lamblia

Pathogenic Escherichia coli

Taenia spp

Plesiomonas shigelloides

Viruses

Salmonella spp Hepatitis A virusShigella spp Mycotoxigenic moulds PoliovirusesStaphylococcus aureus

Aspergillus spp Norwalk virus group

Streptococcus pyogenes

Fusarium spp

Vibrio cholera Penicillium sppV parahaemolyticusV vulnificusYersinia enterocolitica

EXAMPLES OF PHYSICAL HAZARDS amp THEIR SOURCESPhysical hazard

Source

Metal Bolts nuts screws screens sieves steel woolGlass Light bulbs watch crystals thermometers etcWood splinters Pallets equipment bracing overhead structureInsects Environment electrocution traps incoming ingredients Hair Meat ingredients employees clothing rodentsMould Poor sanitation inadequate cleaning of equipmentRodents droppings

Inadequate rodent controls incoming ingredients

Dirt rocks Raw materials poor employee practices Paint flakes Equipment overhead structureBand-aid Poor employee practicesPen caps Poor employee practicesCarcass ID tags Slaughterhouse

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Hypodermic needles

Veterinarian

Bullets shot BBs

Animals shot while in fields

Feathers Poor sanitation inadequate pest ( bird ) controls Gasket material Inadequate preventive maintenance of equipment Grease Poor equipment maintenance programme

NB Please refer to the generic Hazard Analysis Questionnaire ( under CHECKLISTS ) ndash this checklist is for PER PRODUCT USED

INFO can also be obtained from the productsrsquo MSDS ( MATERIAL SAFETY DATASHEET ) AND OR The Productsrsquo Ingredients Listing

EXAMPLE 1 OF HACCP DECISION TREE

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Q1 Does this step involve a hazard of sufficient likelihood of occurrence and severity to warrant its control

Q3 Is control at this step necessary to prevent eliminate or reduce the risk of hazard to consumers

Modify step process or product

Yes

Is control at this step necessary for safety

Q2 Does a control measure for the hazard exist at this step

Yes

Yes

Yes

No

No

No

No

Not a CCP

This is a critical control point

Not a CCP

Not a CCP

EXAMPLE 2 OF HACCP DECISION TREE

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Q2 Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level

No

Yes

Q1 Do control measure(s) exist for the identified hazard

Modify step process or product

Q4 Will a subsequent step prior to consuming the food eliminate the identified hazard(s) or reduce the likely occurrence to an acceptable level

Q3 Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable level(s)

Yes

Yes

Yes

Yes

No

No

No

Is control at this step necessary for safety

Not a CCP

Not a CCP

This is a critical control point

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

Biological Hazards123456789101112131415

Chemical Hazards123456789101112131415

Physical Hazards12

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 25 of 45 Rev 0

3

456789101112131415

Allergen Hazards123456789101112131415

Stage 7 DETERMINING CRITICAL CONTROL POINT (CCPS) (DECISION TREE)

(Principle 2)

The HACCP team shall determine whether a particular step in the food handling process is a CCP

The method by which a CCP is determined shall be recorder

NOTE The decision tree in annex B can be as a guideline

INTRODUCTION

A Critical Control Point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level

If a hazard has been identified at a step where control is necessary for safety and no control measure exists at that step or any other then the product or process should be modified at that step or at any earlier or later stage to include a control measure

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 26 of 45 Rev 0

Determine the Critical Control Points (CCPs)

Each step in the commodity flow diagram within the scope of the HACCP study should be taken in turn and the relevance of each identified hazard should be considered It is also important to remember the stated scope of the HACCP analysis at this stage The team must determine whether the hazard can occur at this step and if so whether control measures exist If the hazard can be controlled adequately and is not best controlled at another step and is essential for food safety then this step is a CCP for the specified hazard A decision tree can be used to determine CCPs However the HACCP teams judgement expertise and knowledge of the process are the major factors in establishing CCPs

If a step is identified where a food safety hazard exists but no adequate control measures can be put in place either at this step or subsequently then the product is unsafe for human consumption Production should cease until control measures are available and a CCP can be introduced

The proper identification of Critical Control Points (CCPs) is crucial to the ultimate effectiveness of a HACCP plan The plan must specify where each identified hazard will be controlled

Hazards that cannot be controlled by the operator must be identified on the HACCP plan The plan must indicate how these hazards will be addressed outside the establishment (ie purchasing pre-frozen fish where the supplier is responsible for the freezing requirements as specified by regulation)

Note The evaluation for completeness of the written CCPs will ensure that all relevant information dealing with critical limits monitoring corrective actions verification procedures and record keeping is specified for each identified hazard

D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S ( C C P S )( C C P S ) (HACCP principle 2)

The determination of a CCP in the HACCP system shall be facilitated using a decision tree ndash as is shown in the following diagram

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 27 of 45 Rev 0

HACCP concept element Application step amp principle

Define the food and the processes involved in production

Break down the process into steps

Determine possible hazards associated with each step and probability of hazard persistence in end product if no affective preventive measures are implemented

Specify control measures

Consequently determine critical control points ( CCPs )

Establish critical limits

Monitor CCPs to ensure proper implementation of control measures

Take corrective action when parameter monitoring indicates failure of control measure

HACCP principles 4 and 5

Application steps 9-10

HACCP principles 2 and 3

Application steps 7-8

HACCP principle 1

Application step 6

Application steps 1-5

System to be reviewed confirmed and audited

Records must be generated for the system to be documented

HACCP principles 6 and 7

Application steps 11-12

Stage 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP (Principle 3)

The HACCP team shall establish specific and measurable critical limits appropriate for each CCP Critical limits that can be measured quickly and easily shall be used Measurements can include sensory examination mass measurements temperature measurements time moisture level PH value and chemical analysis

Records shall be kept

Establish critical limits for each CCP

Critical limits must be specified and validated for each CCP Criteria often used include measurements of temperature time moisture level pH water activity and sensory parameters such as visual appearance In the case of mycotoxins for example they may include the moisture content or the temperature of the commodity All critical limits and the associated permissible tolerances must be documented in the HACCP Plan Worksheet and included as specifications in operating procedures and work instructions

ie Critical limits have to be established for all critical components associated with each hazard that is controlled by a CCP

Critical Limits must meet or exceed relevant regulatory and program requirements Some establishments set critical limits to exceed regulatory requirements This is acceptable but the establishment should be made aware that if these limits are the ones written into the HACCP plan the inspection will be conducted against these more stringent limits

Critical limits normally include measurements such as temperature time moisture level pH aw available chlorine and sensory attributes When applicable compare the critical limits found the establishment HACCP plan to those considered standard industry practice

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 28 of 45 Rev 0

For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 29 of 45 Rev 0

upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 30 of 45 Rev 0

8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 31 of 45 Rev 0

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 32 of 45 Rev 0

Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

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81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

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acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

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Page 11: BLANK HACCP STUDY

823 The HACCP team shall establish documentation defining the scope of the HACCP study and the teamrsquos activities The teamrsquos activities should include establishing the following

a) the rules and guidelines for team meetings

b) the criteria used for decision making processes

c) the methodology to be used by the team to determinehazards and CCPs

d) the methodology for reporting on the status of the HACCP system and

e) the methodology for the establishment for procedural requirements orintegration with other relevant management system procedures

824 Where the necessary skills or knowledge are not available within the food handling organization the service of a consultant may be used on condition that the consultant acts only as an expert advisor to the team

Introduction

There are twelve tasks required to develop a HACCP plan and these are designed to ensure that the seven principles are applied correctly Principle 1 which is to conduct a hazard analysis requires that the first five tasks have all been addressed in a logical and honest manner so that all real hazards associated with the commodity have been identified

Establish a HACCP Team

To fully understand the commodity system and be able to identify all likely hazards and CCPs it is important that the HACCP team is made up of people from a wide range of disciplines The team should include

A team leader to convene the group and to direct the work of the team ensuring that the concept is properly applied This person must be familiar with the technique be a good listener and allow all participants to contribute

A specialist with a detailed knowledge of the commodity system is required This specialist will have a major role in the production of the commodity flow diagrams

Several specialists each with an understanding of particular hazards and associated risks eg a microbiologist a chemist a mycotoxicologist a toxicologist a QC manager a process engineer

People such as packaging specialists raw material buyers distribution staff or production staff farmers brokers who are involved with the process and

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have working knowledge of it may be brought into the team temporarily in order to provide relevant expertise

The teams progress and results of the analysis should be recorded by a technical secretary

If any changes are made to composition or operational procedures it will be necessary to re-assess the HACCP plan in the light of the changes

The first activity of the HACCP team is to identify the scope of the study For example will the whole commodity system be covered or only selected components This will make the task more manageable and specialists can be added to the team as and when they are required

Our HACCP TEAMie Who

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Task 2 DESCRIPTION OF OUR SERVICES

A complete description of the service shall be given in terms of type and composition (allergens microbiological chemical and physical properties) relevant legislation handling processing presentation or packaging storage and distribution condition and the shelf life under prescribed conditions

Describe the Product Service

To start a hazard analysis a full description of the product including customer specification should be prepared This should include information relevant to safety eg mycotoxin regulationtarget level composition physicalchemical properties of the raw materials and the final product the amount of water available for microbial growth (aw) the amount of acid or alkali in the product (pH) Also information regarding how the product is to be packaged stored and transported should also be considered together with facts regarding its shelf life and recommended storage temperatures Where appropriate labelling information and an example of the label should be included This information will help the HACCP team to identify real hazards associated with the process

Activity DescriptionFacility Site

Project Coordinator

Activity

Site Manager

Address

Phone

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SERVICES DESCRIPTIONie What Where amp When

Task 3 IDENTIFYING THE INTENDED USE OF OUR SERVICES

The intended use and possible abuse of the service by consumers consumer groups or customers shall be described Attention shall be focused on the likely uses and abuses of the service after it has left the control of the food handling organization Factors such as the vulnerability of the consumer and instructions for use shall be taken into account

Identify the products Services intended use

How the product is intended to be used is an important consideration Information on whether the product will be consumed directly or be cooked or be further processed will all have a bearing on the hazard analysis see task 6) The nature of the target group for the product may also be relevant particularly if it includes susceptible groups such as infants the elderly and the malnourished The likelihood of misuse of a product should also be considered such as the use of pet food as a human food either by accident or design This information can be recorded on the same form as the product description

INTENDED USE OF OUR SERVICEie Why

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Stage 4 CONSTRUCTION OF OUR SERVICE FLOW DIAGRAM

851 The HACCP team shall prepare a detailed floe diagram for the specified food services or process categories relevant to the defined scope of the HACCP study

852 The following should be considered when preparing the flow diagram

a) the selection of raw material

b) processing activities

d) processing delays

e) packaging and storage

f) distribution retail and customer handling of the service

g) any outsourced processes and

h) removal of intermediary services by-services and waste

853 A floor plan relevant to the areas falling within the defined scope of the HACCP study shall be prepared The following should be considered during the preparation of the floor plan as relevant technical data for an effective evaluation of the service flow

a) layout and design features of equipment

b) service flow of liquids powders raw and cooked foods

c) routes of personnel and their personal hygiene practices

d) service recycle or rework loops

e) routes of potential cross-contamination through movement of materials

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(ingredients returns water packaging materials etc)

f) segregation of high risk areas from low risk areas where a risk of cross-contamination exists

g) storage and distribution conditions of the different materials used in thefood handling process

h) packaging materials used and

I) factory hygiene cleaning and disinfection procedures

Draw up the Commodity Flow Diagram ( CFD )

The first function of the team is to draw up a detailed commodity flow diagram (CFD) of the commodity system or that part of it which is relevant The expertise of the commodity specialist is important at this stage Commodity systems will differ in detail in different parts of the world and even within one country there may be a number of variants Secondary processing will need to be detailed for each facility using generic flows only as a guide

BLANK FOOD SERVICES ndash COMMODITY FLOW DIAGRAMie How

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NOTE For your information only ndash two EXAMPLES of FOOD SERVICESrsquo FLOW DIAGRAMS

1

2

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Receiving

Cooking CCP

Cutting Preparation

Frozen Storage

Cooking CCP

Refrigerated Storage

Serving

Thawing

Serving

Hot Holding CCP

Cooling CCP

Consumption

Reheating CCP

Consumption

Serving

Slicing

Consumption

Serving

Slicing

Cooling CCP

Serving

Hot Holding CCP

Stage 5 ON-SITE CONFIRMATION OF THE COMMODITY FLOWDIAGRAM

The HACCP team shall confirm the accuracy of the flow diagram and the floor plan on site during all stages and hours of operation so as to ensure that the flow diagram floor plan and technical data as described in 853 gives an accurate representation of the operation The flow diagram shall be amended to take into account any deviation from the original diagram

Records shall be kept

On site confirmation of flow diagram

Upon completion of the CFD members of the team should visit the commodity system (eg farm store or manufacturing area) to compare the information present on the CFD with what actually happens in practice This is known as walking the line a step by step practice to check that all information regarding materials practices controls etc have been taken into consideration by the team during the preparation of the CFD Information such as time of harvest drying procedures storage conditions the marketing chain socio-economic factors grading systems and any incentive for improved quality or safety and processing systems should be collected and included in the CFD as appropriate The site for which the HACCP plan is being designed should be visited as many times as possible to ensure that all relevant information has been collected

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Stage 6 LISTING OF OUR FOOD SAFETY HAZARDS AND MEASURESTO CONTROL THE HAZARD

(Principle 1)

871 The HACCP team shall use the confirmed flow diagram including all the technical data as a guide to identify all the potential food safety hazards (inherent and introduced) that might reasonably be expected to occur at each step of the food handling process Relevant legislation related to the food safety hazards and their control shall be considered The hazards shall be considered in the light of the significance likelihood and severity of such a hazard in terms of the safety of the consumer

872 Control measures for each identified food safety hazard shall be established in order to control such a hazard More than one hazard and control measure might be applicable to one step in the process and more than one control measure might be necessary to control a particular hazard

873 Records shall be kept

Identify and analyse hazard(s)

Effective hazard identification and hazard analysis are the keys to a successful HACCP Plan All real or potential hazards that may occur in each ingredient and at each stage of the commodity system should be considered Food safety hazards for HACCP programmes have been classified into three types of hazards

Biological typically foodborne bacterial pathogens such as Salmonella Listeria and E coli also viruses algae parasites and fungi

Chemical There are three principle types of chemical toxins found in foods naturally occurring chemicals eg cyanides in some root crops and allergenic compounds in peanuts toxins produced by micro-organisms eg mycotoxins

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and algal toxins and chemicals added to the commodity by man to control an identified problem eg fungicides or insecticides

Physical contaminants such as broken glass metal fragments insects or stones

The probability that a hazard will occur is called a risk The risk may take a value from zero to one depending on the degree of certainty that the hazard will be absent or that it will be present After hazard identification a hazard analysis must be conducted to understand the relative health risk to man or animal posed by the hazard It is a way of organizing and analyzing the available scientific information on the nature and size of the health risk associated with the hazard The risk may have to be assessed subjectively and simply classified as low medium or high Only those hazards considered by the HACCP team to present an unacceptable risk of being present are taken forward to Stage 7 Principle 2

Once a food safety hazard has been identified then appropriate control measures should be considered These are any action or activity that can be used to control the identified hazard such that it is prevented eliminated or reduced to an acceptable level The control measure may also include training of personnel for a particular operation covered by Good Manufacturing Processes ( GMP)

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

To identify all biological chemical physical and allergen hazards associated with the purchasing delivering storing usage and sale of BLANKrsquos services

Biological Hazards

The following biological hazards were covered by the terms of reference of our HACCP study

1 Yeast amp Moulds2 Coliforms3 E coli4 Listeria5 Salmonella6 Enterobacteriaceae7 Aerobic Mesophile8 Salmonella spp

Chemical Hazards

The following chemical hazards were covered by the terms of reference of our HACCP study

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 20 of 45 Rev 0

1 Cleaning residues2 Printing inks lacquers from packaging3 Chemical contaminants and residues in raw materials

Physical Hazards

The following physical hazards were covered by the terms of reference of our HACCP study

1 Metal2 Glass3 Hair4 Wooden splinters5 Dust dirt particles6 Plastic7 Insects

Allergen Hazards

All the following common allergens were considered as part of our HACCP study

1 Milk2 Egg3 Nuts4 Soya5 Gluten6 Crustaceans7 Fish8 Peanuts9 Celery10 Mustard11 Sesame Seeds12 Sulphites13 Lupin14 Molluscs and products thereof

CHEMICALS USED IN FOOD PROCESSINGPoint of use Type of chemicalGrowing crops Pesticides herbicides defoliants Raising livestock Growth hormones antibiotics Production Food additives processing aids Plant maintenance

Lubricants paints solvents

Plant sanitation Cleaners sanitizing agents pesticides

SOME FOOD-BORNE BIOLOGICAL HAZARDS

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Bacteria Parasites Seafood toxinsAeromonas hydrophila

Anisakis spp Ciguatera fish poisoning

Bacillus cereus Ascaris lumbricoides Gempylotoxin Brucella spp Cyclospora

cayetanensisTetrodotoxin

Campylobacter jejuni

Cryptosporidium parvum

Scombrotoxin ( histamine )

Clostridium botulinum

Diphyllobothrium spp Paralytic neurotoxic and

Clostridium perfringens

Entamoeba histolytica Diarrhetic shellfish poisoning

Listeria monocytogenes

Giardia lamblia

Pathogenic Escherichia coli

Taenia spp

Plesiomonas shigelloides

Viruses

Salmonella spp Hepatitis A virusShigella spp Mycotoxigenic moulds PoliovirusesStaphylococcus aureus

Aspergillus spp Norwalk virus group

Streptococcus pyogenes

Fusarium spp

Vibrio cholera Penicillium sppV parahaemolyticusV vulnificusYersinia enterocolitica

EXAMPLES OF PHYSICAL HAZARDS amp THEIR SOURCESPhysical hazard

Source

Metal Bolts nuts screws screens sieves steel woolGlass Light bulbs watch crystals thermometers etcWood splinters Pallets equipment bracing overhead structureInsects Environment electrocution traps incoming ingredients Hair Meat ingredients employees clothing rodentsMould Poor sanitation inadequate cleaning of equipmentRodents droppings

Inadequate rodent controls incoming ingredients

Dirt rocks Raw materials poor employee practices Paint flakes Equipment overhead structureBand-aid Poor employee practicesPen caps Poor employee practicesCarcass ID tags Slaughterhouse

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Hypodermic needles

Veterinarian

Bullets shot BBs

Animals shot while in fields

Feathers Poor sanitation inadequate pest ( bird ) controls Gasket material Inadequate preventive maintenance of equipment Grease Poor equipment maintenance programme

NB Please refer to the generic Hazard Analysis Questionnaire ( under CHECKLISTS ) ndash this checklist is for PER PRODUCT USED

INFO can also be obtained from the productsrsquo MSDS ( MATERIAL SAFETY DATASHEET ) AND OR The Productsrsquo Ingredients Listing

EXAMPLE 1 OF HACCP DECISION TREE

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Q1 Does this step involve a hazard of sufficient likelihood of occurrence and severity to warrant its control

Q3 Is control at this step necessary to prevent eliminate or reduce the risk of hazard to consumers

Modify step process or product

Yes

Is control at this step necessary for safety

Q2 Does a control measure for the hazard exist at this step

Yes

Yes

Yes

No

No

No

No

Not a CCP

This is a critical control point

Not a CCP

Not a CCP

EXAMPLE 2 OF HACCP DECISION TREE

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Q2 Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level

No

Yes

Q1 Do control measure(s) exist for the identified hazard

Modify step process or product

Q4 Will a subsequent step prior to consuming the food eliminate the identified hazard(s) or reduce the likely occurrence to an acceptable level

Q3 Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable level(s)

Yes

Yes

Yes

Yes

No

No

No

Is control at this step necessary for safety

Not a CCP

Not a CCP

This is a critical control point

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

Biological Hazards123456789101112131415

Chemical Hazards123456789101112131415

Physical Hazards12

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3

456789101112131415

Allergen Hazards123456789101112131415

Stage 7 DETERMINING CRITICAL CONTROL POINT (CCPS) (DECISION TREE)

(Principle 2)

The HACCP team shall determine whether a particular step in the food handling process is a CCP

The method by which a CCP is determined shall be recorder

NOTE The decision tree in annex B can be as a guideline

INTRODUCTION

A Critical Control Point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level

If a hazard has been identified at a step where control is necessary for safety and no control measure exists at that step or any other then the product or process should be modified at that step or at any earlier or later stage to include a control measure

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Determine the Critical Control Points (CCPs)

Each step in the commodity flow diagram within the scope of the HACCP study should be taken in turn and the relevance of each identified hazard should be considered It is also important to remember the stated scope of the HACCP analysis at this stage The team must determine whether the hazard can occur at this step and if so whether control measures exist If the hazard can be controlled adequately and is not best controlled at another step and is essential for food safety then this step is a CCP for the specified hazard A decision tree can be used to determine CCPs However the HACCP teams judgement expertise and knowledge of the process are the major factors in establishing CCPs

If a step is identified where a food safety hazard exists but no adequate control measures can be put in place either at this step or subsequently then the product is unsafe for human consumption Production should cease until control measures are available and a CCP can be introduced

The proper identification of Critical Control Points (CCPs) is crucial to the ultimate effectiveness of a HACCP plan The plan must specify where each identified hazard will be controlled

Hazards that cannot be controlled by the operator must be identified on the HACCP plan The plan must indicate how these hazards will be addressed outside the establishment (ie purchasing pre-frozen fish where the supplier is responsible for the freezing requirements as specified by regulation)

Note The evaluation for completeness of the written CCPs will ensure that all relevant information dealing with critical limits monitoring corrective actions verification procedures and record keeping is specified for each identified hazard

D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S ( C C P S )( C C P S ) (HACCP principle 2)

The determination of a CCP in the HACCP system shall be facilitated using a decision tree ndash as is shown in the following diagram

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HACCP concept element Application step amp principle

Define the food and the processes involved in production

Break down the process into steps

Determine possible hazards associated with each step and probability of hazard persistence in end product if no affective preventive measures are implemented

Specify control measures

Consequently determine critical control points ( CCPs )

Establish critical limits

Monitor CCPs to ensure proper implementation of control measures

Take corrective action when parameter monitoring indicates failure of control measure

HACCP principles 4 and 5

Application steps 9-10

HACCP principles 2 and 3

Application steps 7-8

HACCP principle 1

Application step 6

Application steps 1-5

System to be reviewed confirmed and audited

Records must be generated for the system to be documented

HACCP principles 6 and 7

Application steps 11-12

Stage 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP (Principle 3)

The HACCP team shall establish specific and measurable critical limits appropriate for each CCP Critical limits that can be measured quickly and easily shall be used Measurements can include sensory examination mass measurements temperature measurements time moisture level PH value and chemical analysis

Records shall be kept

Establish critical limits for each CCP

Critical limits must be specified and validated for each CCP Criteria often used include measurements of temperature time moisture level pH water activity and sensory parameters such as visual appearance In the case of mycotoxins for example they may include the moisture content or the temperature of the commodity All critical limits and the associated permissible tolerances must be documented in the HACCP Plan Worksheet and included as specifications in operating procedures and work instructions

ie Critical limits have to be established for all critical components associated with each hazard that is controlled by a CCP

Critical Limits must meet or exceed relevant regulatory and program requirements Some establishments set critical limits to exceed regulatory requirements This is acceptable but the establishment should be made aware that if these limits are the ones written into the HACCP plan the inspection will be conducted against these more stringent limits

Critical limits normally include measurements such as temperature time moisture level pH aw available chlorine and sensory attributes When applicable compare the critical limits found the establishment HACCP plan to those considered standard industry practice

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For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

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upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

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8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

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81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

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acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

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Page 12: BLANK HACCP STUDY

have working knowledge of it may be brought into the team temporarily in order to provide relevant expertise

The teams progress and results of the analysis should be recorded by a technical secretary

If any changes are made to composition or operational procedures it will be necessary to re-assess the HACCP plan in the light of the changes

The first activity of the HACCP team is to identify the scope of the study For example will the whole commodity system be covered or only selected components This will make the task more manageable and specialists can be added to the team as and when they are required

Our HACCP TEAMie Who

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Task 2 DESCRIPTION OF OUR SERVICES

A complete description of the service shall be given in terms of type and composition (allergens microbiological chemical and physical properties) relevant legislation handling processing presentation or packaging storage and distribution condition and the shelf life under prescribed conditions

Describe the Product Service

To start a hazard analysis a full description of the product including customer specification should be prepared This should include information relevant to safety eg mycotoxin regulationtarget level composition physicalchemical properties of the raw materials and the final product the amount of water available for microbial growth (aw) the amount of acid or alkali in the product (pH) Also information regarding how the product is to be packaged stored and transported should also be considered together with facts regarding its shelf life and recommended storage temperatures Where appropriate labelling information and an example of the label should be included This information will help the HACCP team to identify real hazards associated with the process

Activity DescriptionFacility Site

Project Coordinator

Activity

Site Manager

Address

Phone

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SERVICES DESCRIPTIONie What Where amp When

Task 3 IDENTIFYING THE INTENDED USE OF OUR SERVICES

The intended use and possible abuse of the service by consumers consumer groups or customers shall be described Attention shall be focused on the likely uses and abuses of the service after it has left the control of the food handling organization Factors such as the vulnerability of the consumer and instructions for use shall be taken into account

Identify the products Services intended use

How the product is intended to be used is an important consideration Information on whether the product will be consumed directly or be cooked or be further processed will all have a bearing on the hazard analysis see task 6) The nature of the target group for the product may also be relevant particularly if it includes susceptible groups such as infants the elderly and the malnourished The likelihood of misuse of a product should also be considered such as the use of pet food as a human food either by accident or design This information can be recorded on the same form as the product description

INTENDED USE OF OUR SERVICEie Why

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Stage 4 CONSTRUCTION OF OUR SERVICE FLOW DIAGRAM

851 The HACCP team shall prepare a detailed floe diagram for the specified food services or process categories relevant to the defined scope of the HACCP study

852 The following should be considered when preparing the flow diagram

a) the selection of raw material

b) processing activities

d) processing delays

e) packaging and storage

f) distribution retail and customer handling of the service

g) any outsourced processes and

h) removal of intermediary services by-services and waste

853 A floor plan relevant to the areas falling within the defined scope of the HACCP study shall be prepared The following should be considered during the preparation of the floor plan as relevant technical data for an effective evaluation of the service flow

a) layout and design features of equipment

b) service flow of liquids powders raw and cooked foods

c) routes of personnel and their personal hygiene practices

d) service recycle or rework loops

e) routes of potential cross-contamination through movement of materials

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(ingredients returns water packaging materials etc)

f) segregation of high risk areas from low risk areas where a risk of cross-contamination exists

g) storage and distribution conditions of the different materials used in thefood handling process

h) packaging materials used and

I) factory hygiene cleaning and disinfection procedures

Draw up the Commodity Flow Diagram ( CFD )

The first function of the team is to draw up a detailed commodity flow diagram (CFD) of the commodity system or that part of it which is relevant The expertise of the commodity specialist is important at this stage Commodity systems will differ in detail in different parts of the world and even within one country there may be a number of variants Secondary processing will need to be detailed for each facility using generic flows only as a guide

BLANK FOOD SERVICES ndash COMMODITY FLOW DIAGRAMie How

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NOTE For your information only ndash two EXAMPLES of FOOD SERVICESrsquo FLOW DIAGRAMS

1

2

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Receiving

Cooking CCP

Cutting Preparation

Frozen Storage

Cooking CCP

Refrigerated Storage

Serving

Thawing

Serving

Hot Holding CCP

Cooling CCP

Consumption

Reheating CCP

Consumption

Serving

Slicing

Consumption

Serving

Slicing

Cooling CCP

Serving

Hot Holding CCP

Stage 5 ON-SITE CONFIRMATION OF THE COMMODITY FLOWDIAGRAM

The HACCP team shall confirm the accuracy of the flow diagram and the floor plan on site during all stages and hours of operation so as to ensure that the flow diagram floor plan and technical data as described in 853 gives an accurate representation of the operation The flow diagram shall be amended to take into account any deviation from the original diagram

Records shall be kept

On site confirmation of flow diagram

Upon completion of the CFD members of the team should visit the commodity system (eg farm store or manufacturing area) to compare the information present on the CFD with what actually happens in practice This is known as walking the line a step by step practice to check that all information regarding materials practices controls etc have been taken into consideration by the team during the preparation of the CFD Information such as time of harvest drying procedures storage conditions the marketing chain socio-economic factors grading systems and any incentive for improved quality or safety and processing systems should be collected and included in the CFD as appropriate The site for which the HACCP plan is being designed should be visited as many times as possible to ensure that all relevant information has been collected

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Stage 6 LISTING OF OUR FOOD SAFETY HAZARDS AND MEASURESTO CONTROL THE HAZARD

(Principle 1)

871 The HACCP team shall use the confirmed flow diagram including all the technical data as a guide to identify all the potential food safety hazards (inherent and introduced) that might reasonably be expected to occur at each step of the food handling process Relevant legislation related to the food safety hazards and their control shall be considered The hazards shall be considered in the light of the significance likelihood and severity of such a hazard in terms of the safety of the consumer

872 Control measures for each identified food safety hazard shall be established in order to control such a hazard More than one hazard and control measure might be applicable to one step in the process and more than one control measure might be necessary to control a particular hazard

873 Records shall be kept

Identify and analyse hazard(s)

Effective hazard identification and hazard analysis are the keys to a successful HACCP Plan All real or potential hazards that may occur in each ingredient and at each stage of the commodity system should be considered Food safety hazards for HACCP programmes have been classified into three types of hazards

Biological typically foodborne bacterial pathogens such as Salmonella Listeria and E coli also viruses algae parasites and fungi

Chemical There are three principle types of chemical toxins found in foods naturally occurring chemicals eg cyanides in some root crops and allergenic compounds in peanuts toxins produced by micro-organisms eg mycotoxins

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and algal toxins and chemicals added to the commodity by man to control an identified problem eg fungicides or insecticides

Physical contaminants such as broken glass metal fragments insects or stones

The probability that a hazard will occur is called a risk The risk may take a value from zero to one depending on the degree of certainty that the hazard will be absent or that it will be present After hazard identification a hazard analysis must be conducted to understand the relative health risk to man or animal posed by the hazard It is a way of organizing and analyzing the available scientific information on the nature and size of the health risk associated with the hazard The risk may have to be assessed subjectively and simply classified as low medium or high Only those hazards considered by the HACCP team to present an unacceptable risk of being present are taken forward to Stage 7 Principle 2

Once a food safety hazard has been identified then appropriate control measures should be considered These are any action or activity that can be used to control the identified hazard such that it is prevented eliminated or reduced to an acceptable level The control measure may also include training of personnel for a particular operation covered by Good Manufacturing Processes ( GMP)

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

To identify all biological chemical physical and allergen hazards associated with the purchasing delivering storing usage and sale of BLANKrsquos services

Biological Hazards

The following biological hazards were covered by the terms of reference of our HACCP study

1 Yeast amp Moulds2 Coliforms3 E coli4 Listeria5 Salmonella6 Enterobacteriaceae7 Aerobic Mesophile8 Salmonella spp

Chemical Hazards

The following chemical hazards were covered by the terms of reference of our HACCP study

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1 Cleaning residues2 Printing inks lacquers from packaging3 Chemical contaminants and residues in raw materials

Physical Hazards

The following physical hazards were covered by the terms of reference of our HACCP study

1 Metal2 Glass3 Hair4 Wooden splinters5 Dust dirt particles6 Plastic7 Insects

Allergen Hazards

All the following common allergens were considered as part of our HACCP study

1 Milk2 Egg3 Nuts4 Soya5 Gluten6 Crustaceans7 Fish8 Peanuts9 Celery10 Mustard11 Sesame Seeds12 Sulphites13 Lupin14 Molluscs and products thereof

CHEMICALS USED IN FOOD PROCESSINGPoint of use Type of chemicalGrowing crops Pesticides herbicides defoliants Raising livestock Growth hormones antibiotics Production Food additives processing aids Plant maintenance

Lubricants paints solvents

Plant sanitation Cleaners sanitizing agents pesticides

SOME FOOD-BORNE BIOLOGICAL HAZARDS

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Bacteria Parasites Seafood toxinsAeromonas hydrophila

Anisakis spp Ciguatera fish poisoning

Bacillus cereus Ascaris lumbricoides Gempylotoxin Brucella spp Cyclospora

cayetanensisTetrodotoxin

Campylobacter jejuni

Cryptosporidium parvum

Scombrotoxin ( histamine )

Clostridium botulinum

Diphyllobothrium spp Paralytic neurotoxic and

Clostridium perfringens

Entamoeba histolytica Diarrhetic shellfish poisoning

Listeria monocytogenes

Giardia lamblia

Pathogenic Escherichia coli

Taenia spp

Plesiomonas shigelloides

Viruses

Salmonella spp Hepatitis A virusShigella spp Mycotoxigenic moulds PoliovirusesStaphylococcus aureus

Aspergillus spp Norwalk virus group

Streptococcus pyogenes

Fusarium spp

Vibrio cholera Penicillium sppV parahaemolyticusV vulnificusYersinia enterocolitica

EXAMPLES OF PHYSICAL HAZARDS amp THEIR SOURCESPhysical hazard

Source

Metal Bolts nuts screws screens sieves steel woolGlass Light bulbs watch crystals thermometers etcWood splinters Pallets equipment bracing overhead structureInsects Environment electrocution traps incoming ingredients Hair Meat ingredients employees clothing rodentsMould Poor sanitation inadequate cleaning of equipmentRodents droppings

Inadequate rodent controls incoming ingredients

Dirt rocks Raw materials poor employee practices Paint flakes Equipment overhead structureBand-aid Poor employee practicesPen caps Poor employee practicesCarcass ID tags Slaughterhouse

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Hypodermic needles

Veterinarian

Bullets shot BBs

Animals shot while in fields

Feathers Poor sanitation inadequate pest ( bird ) controls Gasket material Inadequate preventive maintenance of equipment Grease Poor equipment maintenance programme

NB Please refer to the generic Hazard Analysis Questionnaire ( under CHECKLISTS ) ndash this checklist is for PER PRODUCT USED

INFO can also be obtained from the productsrsquo MSDS ( MATERIAL SAFETY DATASHEET ) AND OR The Productsrsquo Ingredients Listing

EXAMPLE 1 OF HACCP DECISION TREE

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Q1 Does this step involve a hazard of sufficient likelihood of occurrence and severity to warrant its control

Q3 Is control at this step necessary to prevent eliminate or reduce the risk of hazard to consumers

Modify step process or product

Yes

Is control at this step necessary for safety

Q2 Does a control measure for the hazard exist at this step

Yes

Yes

Yes

No

No

No

No

Not a CCP

This is a critical control point

Not a CCP

Not a CCP

EXAMPLE 2 OF HACCP DECISION TREE

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Q2 Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level

No

Yes

Q1 Do control measure(s) exist for the identified hazard

Modify step process or product

Q4 Will a subsequent step prior to consuming the food eliminate the identified hazard(s) or reduce the likely occurrence to an acceptable level

Q3 Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable level(s)

Yes

Yes

Yes

Yes

No

No

No

Is control at this step necessary for safety

Not a CCP

Not a CCP

This is a critical control point

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

Biological Hazards123456789101112131415

Chemical Hazards123456789101112131415

Physical Hazards12

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 25 of 45 Rev 0

3

456789101112131415

Allergen Hazards123456789101112131415

Stage 7 DETERMINING CRITICAL CONTROL POINT (CCPS) (DECISION TREE)

(Principle 2)

The HACCP team shall determine whether a particular step in the food handling process is a CCP

The method by which a CCP is determined shall be recorder

NOTE The decision tree in annex B can be as a guideline

INTRODUCTION

A Critical Control Point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level

If a hazard has been identified at a step where control is necessary for safety and no control measure exists at that step or any other then the product or process should be modified at that step or at any earlier or later stage to include a control measure

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 26 of 45 Rev 0

Determine the Critical Control Points (CCPs)

Each step in the commodity flow diagram within the scope of the HACCP study should be taken in turn and the relevance of each identified hazard should be considered It is also important to remember the stated scope of the HACCP analysis at this stage The team must determine whether the hazard can occur at this step and if so whether control measures exist If the hazard can be controlled adequately and is not best controlled at another step and is essential for food safety then this step is a CCP for the specified hazard A decision tree can be used to determine CCPs However the HACCP teams judgement expertise and knowledge of the process are the major factors in establishing CCPs

If a step is identified where a food safety hazard exists but no adequate control measures can be put in place either at this step or subsequently then the product is unsafe for human consumption Production should cease until control measures are available and a CCP can be introduced

The proper identification of Critical Control Points (CCPs) is crucial to the ultimate effectiveness of a HACCP plan The plan must specify where each identified hazard will be controlled

Hazards that cannot be controlled by the operator must be identified on the HACCP plan The plan must indicate how these hazards will be addressed outside the establishment (ie purchasing pre-frozen fish where the supplier is responsible for the freezing requirements as specified by regulation)

Note The evaluation for completeness of the written CCPs will ensure that all relevant information dealing with critical limits monitoring corrective actions verification procedures and record keeping is specified for each identified hazard

D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S ( C C P S )( C C P S ) (HACCP principle 2)

The determination of a CCP in the HACCP system shall be facilitated using a decision tree ndash as is shown in the following diagram

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 27 of 45 Rev 0

HACCP concept element Application step amp principle

Define the food and the processes involved in production

Break down the process into steps

Determine possible hazards associated with each step and probability of hazard persistence in end product if no affective preventive measures are implemented

Specify control measures

Consequently determine critical control points ( CCPs )

Establish critical limits

Monitor CCPs to ensure proper implementation of control measures

Take corrective action when parameter monitoring indicates failure of control measure

HACCP principles 4 and 5

Application steps 9-10

HACCP principles 2 and 3

Application steps 7-8

HACCP principle 1

Application step 6

Application steps 1-5

System to be reviewed confirmed and audited

Records must be generated for the system to be documented

HACCP principles 6 and 7

Application steps 11-12

Stage 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP (Principle 3)

The HACCP team shall establish specific and measurable critical limits appropriate for each CCP Critical limits that can be measured quickly and easily shall be used Measurements can include sensory examination mass measurements temperature measurements time moisture level PH value and chemical analysis

Records shall be kept

Establish critical limits for each CCP

Critical limits must be specified and validated for each CCP Criteria often used include measurements of temperature time moisture level pH water activity and sensory parameters such as visual appearance In the case of mycotoxins for example they may include the moisture content or the temperature of the commodity All critical limits and the associated permissible tolerances must be documented in the HACCP Plan Worksheet and included as specifications in operating procedures and work instructions

ie Critical limits have to be established for all critical components associated with each hazard that is controlled by a CCP

Critical Limits must meet or exceed relevant regulatory and program requirements Some establishments set critical limits to exceed regulatory requirements This is acceptable but the establishment should be made aware that if these limits are the ones written into the HACCP plan the inspection will be conducted against these more stringent limits

Critical limits normally include measurements such as temperature time moisture level pH aw available chlorine and sensory attributes When applicable compare the critical limits found the establishment HACCP plan to those considered standard industry practice

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For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

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upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

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8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 36 of 45 Rev 0

81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 37 of 45 Rev 0

81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 39 of 45 Rev 0

HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 43 of 45 Rev 0

acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 45 of 45 Rev 0

Page 13: BLANK HACCP STUDY

Task 2 DESCRIPTION OF OUR SERVICES

A complete description of the service shall be given in terms of type and composition (allergens microbiological chemical and physical properties) relevant legislation handling processing presentation or packaging storage and distribution condition and the shelf life under prescribed conditions

Describe the Product Service

To start a hazard analysis a full description of the product including customer specification should be prepared This should include information relevant to safety eg mycotoxin regulationtarget level composition physicalchemical properties of the raw materials and the final product the amount of water available for microbial growth (aw) the amount of acid or alkali in the product (pH) Also information regarding how the product is to be packaged stored and transported should also be considered together with facts regarding its shelf life and recommended storage temperatures Where appropriate labelling information and an example of the label should be included This information will help the HACCP team to identify real hazards associated with the process

Activity DescriptionFacility Site

Project Coordinator

Activity

Site Manager

Address

Phone

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 13 of 45 Rev 0

SERVICES DESCRIPTIONie What Where amp When

Task 3 IDENTIFYING THE INTENDED USE OF OUR SERVICES

The intended use and possible abuse of the service by consumers consumer groups or customers shall be described Attention shall be focused on the likely uses and abuses of the service after it has left the control of the food handling organization Factors such as the vulnerability of the consumer and instructions for use shall be taken into account

Identify the products Services intended use

How the product is intended to be used is an important consideration Information on whether the product will be consumed directly or be cooked or be further processed will all have a bearing on the hazard analysis see task 6) The nature of the target group for the product may also be relevant particularly if it includes susceptible groups such as infants the elderly and the malnourished The likelihood of misuse of a product should also be considered such as the use of pet food as a human food either by accident or design This information can be recorded on the same form as the product description

INTENDED USE OF OUR SERVICEie Why

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Stage 4 CONSTRUCTION OF OUR SERVICE FLOW DIAGRAM

851 The HACCP team shall prepare a detailed floe diagram for the specified food services or process categories relevant to the defined scope of the HACCP study

852 The following should be considered when preparing the flow diagram

a) the selection of raw material

b) processing activities

d) processing delays

e) packaging and storage

f) distribution retail and customer handling of the service

g) any outsourced processes and

h) removal of intermediary services by-services and waste

853 A floor plan relevant to the areas falling within the defined scope of the HACCP study shall be prepared The following should be considered during the preparation of the floor plan as relevant technical data for an effective evaluation of the service flow

a) layout and design features of equipment

b) service flow of liquids powders raw and cooked foods

c) routes of personnel and their personal hygiene practices

d) service recycle or rework loops

e) routes of potential cross-contamination through movement of materials

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(ingredients returns water packaging materials etc)

f) segregation of high risk areas from low risk areas where a risk of cross-contamination exists

g) storage and distribution conditions of the different materials used in thefood handling process

h) packaging materials used and

I) factory hygiene cleaning and disinfection procedures

Draw up the Commodity Flow Diagram ( CFD )

The first function of the team is to draw up a detailed commodity flow diagram (CFD) of the commodity system or that part of it which is relevant The expertise of the commodity specialist is important at this stage Commodity systems will differ in detail in different parts of the world and even within one country there may be a number of variants Secondary processing will need to be detailed for each facility using generic flows only as a guide

BLANK FOOD SERVICES ndash COMMODITY FLOW DIAGRAMie How

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NOTE For your information only ndash two EXAMPLES of FOOD SERVICESrsquo FLOW DIAGRAMS

1

2

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 17 of 45 Rev 0

Receiving

Cooking CCP

Cutting Preparation

Frozen Storage

Cooking CCP

Refrigerated Storage

Serving

Thawing

Serving

Hot Holding CCP

Cooling CCP

Consumption

Reheating CCP

Consumption

Serving

Slicing

Consumption

Serving

Slicing

Cooling CCP

Serving

Hot Holding CCP

Stage 5 ON-SITE CONFIRMATION OF THE COMMODITY FLOWDIAGRAM

The HACCP team shall confirm the accuracy of the flow diagram and the floor plan on site during all stages and hours of operation so as to ensure that the flow diagram floor plan and technical data as described in 853 gives an accurate representation of the operation The flow diagram shall be amended to take into account any deviation from the original diagram

Records shall be kept

On site confirmation of flow diagram

Upon completion of the CFD members of the team should visit the commodity system (eg farm store or manufacturing area) to compare the information present on the CFD with what actually happens in practice This is known as walking the line a step by step practice to check that all information regarding materials practices controls etc have been taken into consideration by the team during the preparation of the CFD Information such as time of harvest drying procedures storage conditions the marketing chain socio-economic factors grading systems and any incentive for improved quality or safety and processing systems should be collected and included in the CFD as appropriate The site for which the HACCP plan is being designed should be visited as many times as possible to ensure that all relevant information has been collected

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Stage 6 LISTING OF OUR FOOD SAFETY HAZARDS AND MEASURESTO CONTROL THE HAZARD

(Principle 1)

871 The HACCP team shall use the confirmed flow diagram including all the technical data as a guide to identify all the potential food safety hazards (inherent and introduced) that might reasonably be expected to occur at each step of the food handling process Relevant legislation related to the food safety hazards and their control shall be considered The hazards shall be considered in the light of the significance likelihood and severity of such a hazard in terms of the safety of the consumer

872 Control measures for each identified food safety hazard shall be established in order to control such a hazard More than one hazard and control measure might be applicable to one step in the process and more than one control measure might be necessary to control a particular hazard

873 Records shall be kept

Identify and analyse hazard(s)

Effective hazard identification and hazard analysis are the keys to a successful HACCP Plan All real or potential hazards that may occur in each ingredient and at each stage of the commodity system should be considered Food safety hazards for HACCP programmes have been classified into three types of hazards

Biological typically foodborne bacterial pathogens such as Salmonella Listeria and E coli also viruses algae parasites and fungi

Chemical There are three principle types of chemical toxins found in foods naturally occurring chemicals eg cyanides in some root crops and allergenic compounds in peanuts toxins produced by micro-organisms eg mycotoxins

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and algal toxins and chemicals added to the commodity by man to control an identified problem eg fungicides or insecticides

Physical contaminants such as broken glass metal fragments insects or stones

The probability that a hazard will occur is called a risk The risk may take a value from zero to one depending on the degree of certainty that the hazard will be absent or that it will be present After hazard identification a hazard analysis must be conducted to understand the relative health risk to man or animal posed by the hazard It is a way of organizing and analyzing the available scientific information on the nature and size of the health risk associated with the hazard The risk may have to be assessed subjectively and simply classified as low medium or high Only those hazards considered by the HACCP team to present an unacceptable risk of being present are taken forward to Stage 7 Principle 2

Once a food safety hazard has been identified then appropriate control measures should be considered These are any action or activity that can be used to control the identified hazard such that it is prevented eliminated or reduced to an acceptable level The control measure may also include training of personnel for a particular operation covered by Good Manufacturing Processes ( GMP)

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

To identify all biological chemical physical and allergen hazards associated with the purchasing delivering storing usage and sale of BLANKrsquos services

Biological Hazards

The following biological hazards were covered by the terms of reference of our HACCP study

1 Yeast amp Moulds2 Coliforms3 E coli4 Listeria5 Salmonella6 Enterobacteriaceae7 Aerobic Mesophile8 Salmonella spp

Chemical Hazards

The following chemical hazards were covered by the terms of reference of our HACCP study

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1 Cleaning residues2 Printing inks lacquers from packaging3 Chemical contaminants and residues in raw materials

Physical Hazards

The following physical hazards were covered by the terms of reference of our HACCP study

1 Metal2 Glass3 Hair4 Wooden splinters5 Dust dirt particles6 Plastic7 Insects

Allergen Hazards

All the following common allergens were considered as part of our HACCP study

1 Milk2 Egg3 Nuts4 Soya5 Gluten6 Crustaceans7 Fish8 Peanuts9 Celery10 Mustard11 Sesame Seeds12 Sulphites13 Lupin14 Molluscs and products thereof

CHEMICALS USED IN FOOD PROCESSINGPoint of use Type of chemicalGrowing crops Pesticides herbicides defoliants Raising livestock Growth hormones antibiotics Production Food additives processing aids Plant maintenance

Lubricants paints solvents

Plant sanitation Cleaners sanitizing agents pesticides

SOME FOOD-BORNE BIOLOGICAL HAZARDS

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Bacteria Parasites Seafood toxinsAeromonas hydrophila

Anisakis spp Ciguatera fish poisoning

Bacillus cereus Ascaris lumbricoides Gempylotoxin Brucella spp Cyclospora

cayetanensisTetrodotoxin

Campylobacter jejuni

Cryptosporidium parvum

Scombrotoxin ( histamine )

Clostridium botulinum

Diphyllobothrium spp Paralytic neurotoxic and

Clostridium perfringens

Entamoeba histolytica Diarrhetic shellfish poisoning

Listeria monocytogenes

Giardia lamblia

Pathogenic Escherichia coli

Taenia spp

Plesiomonas shigelloides

Viruses

Salmonella spp Hepatitis A virusShigella spp Mycotoxigenic moulds PoliovirusesStaphylococcus aureus

Aspergillus spp Norwalk virus group

Streptococcus pyogenes

Fusarium spp

Vibrio cholera Penicillium sppV parahaemolyticusV vulnificusYersinia enterocolitica

EXAMPLES OF PHYSICAL HAZARDS amp THEIR SOURCESPhysical hazard

Source

Metal Bolts nuts screws screens sieves steel woolGlass Light bulbs watch crystals thermometers etcWood splinters Pallets equipment bracing overhead structureInsects Environment electrocution traps incoming ingredients Hair Meat ingredients employees clothing rodentsMould Poor sanitation inadequate cleaning of equipmentRodents droppings

Inadequate rodent controls incoming ingredients

Dirt rocks Raw materials poor employee practices Paint flakes Equipment overhead structureBand-aid Poor employee practicesPen caps Poor employee practicesCarcass ID tags Slaughterhouse

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 22 of 45 Rev 0

Hypodermic needles

Veterinarian

Bullets shot BBs

Animals shot while in fields

Feathers Poor sanitation inadequate pest ( bird ) controls Gasket material Inadequate preventive maintenance of equipment Grease Poor equipment maintenance programme

NB Please refer to the generic Hazard Analysis Questionnaire ( under CHECKLISTS ) ndash this checklist is for PER PRODUCT USED

INFO can also be obtained from the productsrsquo MSDS ( MATERIAL SAFETY DATASHEET ) AND OR The Productsrsquo Ingredients Listing

EXAMPLE 1 OF HACCP DECISION TREE

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 23 of 45 Rev 0

Q1 Does this step involve a hazard of sufficient likelihood of occurrence and severity to warrant its control

Q3 Is control at this step necessary to prevent eliminate or reduce the risk of hazard to consumers

Modify step process or product

Yes

Is control at this step necessary for safety

Q2 Does a control measure for the hazard exist at this step

Yes

Yes

Yes

No

No

No

No

Not a CCP

This is a critical control point

Not a CCP

Not a CCP

EXAMPLE 2 OF HACCP DECISION TREE

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 24 of 45 Rev 0

Q2 Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level

No

Yes

Q1 Do control measure(s) exist for the identified hazard

Modify step process or product

Q4 Will a subsequent step prior to consuming the food eliminate the identified hazard(s) or reduce the likely occurrence to an acceptable level

Q3 Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable level(s)

Yes

Yes

Yes

Yes

No

No

No

Is control at this step necessary for safety

Not a CCP

Not a CCP

This is a critical control point

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

Biological Hazards123456789101112131415

Chemical Hazards123456789101112131415

Physical Hazards12

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 25 of 45 Rev 0

3

456789101112131415

Allergen Hazards123456789101112131415

Stage 7 DETERMINING CRITICAL CONTROL POINT (CCPS) (DECISION TREE)

(Principle 2)

The HACCP team shall determine whether a particular step in the food handling process is a CCP

The method by which a CCP is determined shall be recorder

NOTE The decision tree in annex B can be as a guideline

INTRODUCTION

A Critical Control Point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level

If a hazard has been identified at a step where control is necessary for safety and no control measure exists at that step or any other then the product or process should be modified at that step or at any earlier or later stage to include a control measure

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 26 of 45 Rev 0

Determine the Critical Control Points (CCPs)

Each step in the commodity flow diagram within the scope of the HACCP study should be taken in turn and the relevance of each identified hazard should be considered It is also important to remember the stated scope of the HACCP analysis at this stage The team must determine whether the hazard can occur at this step and if so whether control measures exist If the hazard can be controlled adequately and is not best controlled at another step and is essential for food safety then this step is a CCP for the specified hazard A decision tree can be used to determine CCPs However the HACCP teams judgement expertise and knowledge of the process are the major factors in establishing CCPs

If a step is identified where a food safety hazard exists but no adequate control measures can be put in place either at this step or subsequently then the product is unsafe for human consumption Production should cease until control measures are available and a CCP can be introduced

The proper identification of Critical Control Points (CCPs) is crucial to the ultimate effectiveness of a HACCP plan The plan must specify where each identified hazard will be controlled

Hazards that cannot be controlled by the operator must be identified on the HACCP plan The plan must indicate how these hazards will be addressed outside the establishment (ie purchasing pre-frozen fish where the supplier is responsible for the freezing requirements as specified by regulation)

Note The evaluation for completeness of the written CCPs will ensure that all relevant information dealing with critical limits monitoring corrective actions verification procedures and record keeping is specified for each identified hazard

D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S ( C C P S )( C C P S ) (HACCP principle 2)

The determination of a CCP in the HACCP system shall be facilitated using a decision tree ndash as is shown in the following diagram

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 27 of 45 Rev 0

HACCP concept element Application step amp principle

Define the food and the processes involved in production

Break down the process into steps

Determine possible hazards associated with each step and probability of hazard persistence in end product if no affective preventive measures are implemented

Specify control measures

Consequently determine critical control points ( CCPs )

Establish critical limits

Monitor CCPs to ensure proper implementation of control measures

Take corrective action when parameter monitoring indicates failure of control measure

HACCP principles 4 and 5

Application steps 9-10

HACCP principles 2 and 3

Application steps 7-8

HACCP principle 1

Application step 6

Application steps 1-5

System to be reviewed confirmed and audited

Records must be generated for the system to be documented

HACCP principles 6 and 7

Application steps 11-12

Stage 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP (Principle 3)

The HACCP team shall establish specific and measurable critical limits appropriate for each CCP Critical limits that can be measured quickly and easily shall be used Measurements can include sensory examination mass measurements temperature measurements time moisture level PH value and chemical analysis

Records shall be kept

Establish critical limits for each CCP

Critical limits must be specified and validated for each CCP Criteria often used include measurements of temperature time moisture level pH water activity and sensory parameters such as visual appearance In the case of mycotoxins for example they may include the moisture content or the temperature of the commodity All critical limits and the associated permissible tolerances must be documented in the HACCP Plan Worksheet and included as specifications in operating procedures and work instructions

ie Critical limits have to be established for all critical components associated with each hazard that is controlled by a CCP

Critical Limits must meet or exceed relevant regulatory and program requirements Some establishments set critical limits to exceed regulatory requirements This is acceptable but the establishment should be made aware that if these limits are the ones written into the HACCP plan the inspection will be conducted against these more stringent limits

Critical limits normally include measurements such as temperature time moisture level pH aw available chlorine and sensory attributes When applicable compare the critical limits found the establishment HACCP plan to those considered standard industry practice

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For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

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upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

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8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

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81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

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acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

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Page 14: BLANK HACCP STUDY

SERVICES DESCRIPTIONie What Where amp When

Task 3 IDENTIFYING THE INTENDED USE OF OUR SERVICES

The intended use and possible abuse of the service by consumers consumer groups or customers shall be described Attention shall be focused on the likely uses and abuses of the service after it has left the control of the food handling organization Factors such as the vulnerability of the consumer and instructions for use shall be taken into account

Identify the products Services intended use

How the product is intended to be used is an important consideration Information on whether the product will be consumed directly or be cooked or be further processed will all have a bearing on the hazard analysis see task 6) The nature of the target group for the product may also be relevant particularly if it includes susceptible groups such as infants the elderly and the malnourished The likelihood of misuse of a product should also be considered such as the use of pet food as a human food either by accident or design This information can be recorded on the same form as the product description

INTENDED USE OF OUR SERVICEie Why

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Stage 4 CONSTRUCTION OF OUR SERVICE FLOW DIAGRAM

851 The HACCP team shall prepare a detailed floe diagram for the specified food services or process categories relevant to the defined scope of the HACCP study

852 The following should be considered when preparing the flow diagram

a) the selection of raw material

b) processing activities

d) processing delays

e) packaging and storage

f) distribution retail and customer handling of the service

g) any outsourced processes and

h) removal of intermediary services by-services and waste

853 A floor plan relevant to the areas falling within the defined scope of the HACCP study shall be prepared The following should be considered during the preparation of the floor plan as relevant technical data for an effective evaluation of the service flow

a) layout and design features of equipment

b) service flow of liquids powders raw and cooked foods

c) routes of personnel and their personal hygiene practices

d) service recycle or rework loops

e) routes of potential cross-contamination through movement of materials

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(ingredients returns water packaging materials etc)

f) segregation of high risk areas from low risk areas where a risk of cross-contamination exists

g) storage and distribution conditions of the different materials used in thefood handling process

h) packaging materials used and

I) factory hygiene cleaning and disinfection procedures

Draw up the Commodity Flow Diagram ( CFD )

The first function of the team is to draw up a detailed commodity flow diagram (CFD) of the commodity system or that part of it which is relevant The expertise of the commodity specialist is important at this stage Commodity systems will differ in detail in different parts of the world and even within one country there may be a number of variants Secondary processing will need to be detailed for each facility using generic flows only as a guide

BLANK FOOD SERVICES ndash COMMODITY FLOW DIAGRAMie How

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NOTE For your information only ndash two EXAMPLES of FOOD SERVICESrsquo FLOW DIAGRAMS

1

2

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Receiving

Cooking CCP

Cutting Preparation

Frozen Storage

Cooking CCP

Refrigerated Storage

Serving

Thawing

Serving

Hot Holding CCP

Cooling CCP

Consumption

Reheating CCP

Consumption

Serving

Slicing

Consumption

Serving

Slicing

Cooling CCP

Serving

Hot Holding CCP

Stage 5 ON-SITE CONFIRMATION OF THE COMMODITY FLOWDIAGRAM

The HACCP team shall confirm the accuracy of the flow diagram and the floor plan on site during all stages and hours of operation so as to ensure that the flow diagram floor plan and technical data as described in 853 gives an accurate representation of the operation The flow diagram shall be amended to take into account any deviation from the original diagram

Records shall be kept

On site confirmation of flow diagram

Upon completion of the CFD members of the team should visit the commodity system (eg farm store or manufacturing area) to compare the information present on the CFD with what actually happens in practice This is known as walking the line a step by step practice to check that all information regarding materials practices controls etc have been taken into consideration by the team during the preparation of the CFD Information such as time of harvest drying procedures storage conditions the marketing chain socio-economic factors grading systems and any incentive for improved quality or safety and processing systems should be collected and included in the CFD as appropriate The site for which the HACCP plan is being designed should be visited as many times as possible to ensure that all relevant information has been collected

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Stage 6 LISTING OF OUR FOOD SAFETY HAZARDS AND MEASURESTO CONTROL THE HAZARD

(Principle 1)

871 The HACCP team shall use the confirmed flow diagram including all the technical data as a guide to identify all the potential food safety hazards (inherent and introduced) that might reasonably be expected to occur at each step of the food handling process Relevant legislation related to the food safety hazards and their control shall be considered The hazards shall be considered in the light of the significance likelihood and severity of such a hazard in terms of the safety of the consumer

872 Control measures for each identified food safety hazard shall be established in order to control such a hazard More than one hazard and control measure might be applicable to one step in the process and more than one control measure might be necessary to control a particular hazard

873 Records shall be kept

Identify and analyse hazard(s)

Effective hazard identification and hazard analysis are the keys to a successful HACCP Plan All real or potential hazards that may occur in each ingredient and at each stage of the commodity system should be considered Food safety hazards for HACCP programmes have been classified into three types of hazards

Biological typically foodborne bacterial pathogens such as Salmonella Listeria and E coli also viruses algae parasites and fungi

Chemical There are three principle types of chemical toxins found in foods naturally occurring chemicals eg cyanides in some root crops and allergenic compounds in peanuts toxins produced by micro-organisms eg mycotoxins

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and algal toxins and chemicals added to the commodity by man to control an identified problem eg fungicides or insecticides

Physical contaminants such as broken glass metal fragments insects or stones

The probability that a hazard will occur is called a risk The risk may take a value from zero to one depending on the degree of certainty that the hazard will be absent or that it will be present After hazard identification a hazard analysis must be conducted to understand the relative health risk to man or animal posed by the hazard It is a way of organizing and analyzing the available scientific information on the nature and size of the health risk associated with the hazard The risk may have to be assessed subjectively and simply classified as low medium or high Only those hazards considered by the HACCP team to present an unacceptable risk of being present are taken forward to Stage 7 Principle 2

Once a food safety hazard has been identified then appropriate control measures should be considered These are any action or activity that can be used to control the identified hazard such that it is prevented eliminated or reduced to an acceptable level The control measure may also include training of personnel for a particular operation covered by Good Manufacturing Processes ( GMP)

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

To identify all biological chemical physical and allergen hazards associated with the purchasing delivering storing usage and sale of BLANKrsquos services

Biological Hazards

The following biological hazards were covered by the terms of reference of our HACCP study

1 Yeast amp Moulds2 Coliforms3 E coli4 Listeria5 Salmonella6 Enterobacteriaceae7 Aerobic Mesophile8 Salmonella spp

Chemical Hazards

The following chemical hazards were covered by the terms of reference of our HACCP study

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1 Cleaning residues2 Printing inks lacquers from packaging3 Chemical contaminants and residues in raw materials

Physical Hazards

The following physical hazards were covered by the terms of reference of our HACCP study

1 Metal2 Glass3 Hair4 Wooden splinters5 Dust dirt particles6 Plastic7 Insects

Allergen Hazards

All the following common allergens were considered as part of our HACCP study

1 Milk2 Egg3 Nuts4 Soya5 Gluten6 Crustaceans7 Fish8 Peanuts9 Celery10 Mustard11 Sesame Seeds12 Sulphites13 Lupin14 Molluscs and products thereof

CHEMICALS USED IN FOOD PROCESSINGPoint of use Type of chemicalGrowing crops Pesticides herbicides defoliants Raising livestock Growth hormones antibiotics Production Food additives processing aids Plant maintenance

Lubricants paints solvents

Plant sanitation Cleaners sanitizing agents pesticides

SOME FOOD-BORNE BIOLOGICAL HAZARDS

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Bacteria Parasites Seafood toxinsAeromonas hydrophila

Anisakis spp Ciguatera fish poisoning

Bacillus cereus Ascaris lumbricoides Gempylotoxin Brucella spp Cyclospora

cayetanensisTetrodotoxin

Campylobacter jejuni

Cryptosporidium parvum

Scombrotoxin ( histamine )

Clostridium botulinum

Diphyllobothrium spp Paralytic neurotoxic and

Clostridium perfringens

Entamoeba histolytica Diarrhetic shellfish poisoning

Listeria monocytogenes

Giardia lamblia

Pathogenic Escherichia coli

Taenia spp

Plesiomonas shigelloides

Viruses

Salmonella spp Hepatitis A virusShigella spp Mycotoxigenic moulds PoliovirusesStaphylococcus aureus

Aspergillus spp Norwalk virus group

Streptococcus pyogenes

Fusarium spp

Vibrio cholera Penicillium sppV parahaemolyticusV vulnificusYersinia enterocolitica

EXAMPLES OF PHYSICAL HAZARDS amp THEIR SOURCESPhysical hazard

Source

Metal Bolts nuts screws screens sieves steel woolGlass Light bulbs watch crystals thermometers etcWood splinters Pallets equipment bracing overhead structureInsects Environment electrocution traps incoming ingredients Hair Meat ingredients employees clothing rodentsMould Poor sanitation inadequate cleaning of equipmentRodents droppings

Inadequate rodent controls incoming ingredients

Dirt rocks Raw materials poor employee practices Paint flakes Equipment overhead structureBand-aid Poor employee practicesPen caps Poor employee practicesCarcass ID tags Slaughterhouse

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Hypodermic needles

Veterinarian

Bullets shot BBs

Animals shot while in fields

Feathers Poor sanitation inadequate pest ( bird ) controls Gasket material Inadequate preventive maintenance of equipment Grease Poor equipment maintenance programme

NB Please refer to the generic Hazard Analysis Questionnaire ( under CHECKLISTS ) ndash this checklist is for PER PRODUCT USED

INFO can also be obtained from the productsrsquo MSDS ( MATERIAL SAFETY DATASHEET ) AND OR The Productsrsquo Ingredients Listing

EXAMPLE 1 OF HACCP DECISION TREE

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Q1 Does this step involve a hazard of sufficient likelihood of occurrence and severity to warrant its control

Q3 Is control at this step necessary to prevent eliminate or reduce the risk of hazard to consumers

Modify step process or product

Yes

Is control at this step necessary for safety

Q2 Does a control measure for the hazard exist at this step

Yes

Yes

Yes

No

No

No

No

Not a CCP

This is a critical control point

Not a CCP

Not a CCP

EXAMPLE 2 OF HACCP DECISION TREE

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Q2 Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level

No

Yes

Q1 Do control measure(s) exist for the identified hazard

Modify step process or product

Q4 Will a subsequent step prior to consuming the food eliminate the identified hazard(s) or reduce the likely occurrence to an acceptable level

Q3 Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable level(s)

Yes

Yes

Yes

Yes

No

No

No

Is control at this step necessary for safety

Not a CCP

Not a CCP

This is a critical control point

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

Biological Hazards123456789101112131415

Chemical Hazards123456789101112131415

Physical Hazards12

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 25 of 45 Rev 0

3

456789101112131415

Allergen Hazards123456789101112131415

Stage 7 DETERMINING CRITICAL CONTROL POINT (CCPS) (DECISION TREE)

(Principle 2)

The HACCP team shall determine whether a particular step in the food handling process is a CCP

The method by which a CCP is determined shall be recorder

NOTE The decision tree in annex B can be as a guideline

INTRODUCTION

A Critical Control Point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level

If a hazard has been identified at a step where control is necessary for safety and no control measure exists at that step or any other then the product or process should be modified at that step or at any earlier or later stage to include a control measure

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 26 of 45 Rev 0

Determine the Critical Control Points (CCPs)

Each step in the commodity flow diagram within the scope of the HACCP study should be taken in turn and the relevance of each identified hazard should be considered It is also important to remember the stated scope of the HACCP analysis at this stage The team must determine whether the hazard can occur at this step and if so whether control measures exist If the hazard can be controlled adequately and is not best controlled at another step and is essential for food safety then this step is a CCP for the specified hazard A decision tree can be used to determine CCPs However the HACCP teams judgement expertise and knowledge of the process are the major factors in establishing CCPs

If a step is identified where a food safety hazard exists but no adequate control measures can be put in place either at this step or subsequently then the product is unsafe for human consumption Production should cease until control measures are available and a CCP can be introduced

The proper identification of Critical Control Points (CCPs) is crucial to the ultimate effectiveness of a HACCP plan The plan must specify where each identified hazard will be controlled

Hazards that cannot be controlled by the operator must be identified on the HACCP plan The plan must indicate how these hazards will be addressed outside the establishment (ie purchasing pre-frozen fish where the supplier is responsible for the freezing requirements as specified by regulation)

Note The evaluation for completeness of the written CCPs will ensure that all relevant information dealing with critical limits monitoring corrective actions verification procedures and record keeping is specified for each identified hazard

D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S ( C C P S )( C C P S ) (HACCP principle 2)

The determination of a CCP in the HACCP system shall be facilitated using a decision tree ndash as is shown in the following diagram

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 27 of 45 Rev 0

HACCP concept element Application step amp principle

Define the food and the processes involved in production

Break down the process into steps

Determine possible hazards associated with each step and probability of hazard persistence in end product if no affective preventive measures are implemented

Specify control measures

Consequently determine critical control points ( CCPs )

Establish critical limits

Monitor CCPs to ensure proper implementation of control measures

Take corrective action when parameter monitoring indicates failure of control measure

HACCP principles 4 and 5

Application steps 9-10

HACCP principles 2 and 3

Application steps 7-8

HACCP principle 1

Application step 6

Application steps 1-5

System to be reviewed confirmed and audited

Records must be generated for the system to be documented

HACCP principles 6 and 7

Application steps 11-12

Stage 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP (Principle 3)

The HACCP team shall establish specific and measurable critical limits appropriate for each CCP Critical limits that can be measured quickly and easily shall be used Measurements can include sensory examination mass measurements temperature measurements time moisture level PH value and chemical analysis

Records shall be kept

Establish critical limits for each CCP

Critical limits must be specified and validated for each CCP Criteria often used include measurements of temperature time moisture level pH water activity and sensory parameters such as visual appearance In the case of mycotoxins for example they may include the moisture content or the temperature of the commodity All critical limits and the associated permissible tolerances must be documented in the HACCP Plan Worksheet and included as specifications in operating procedures and work instructions

ie Critical limits have to be established for all critical components associated with each hazard that is controlled by a CCP

Critical Limits must meet or exceed relevant regulatory and program requirements Some establishments set critical limits to exceed regulatory requirements This is acceptable but the establishment should be made aware that if these limits are the ones written into the HACCP plan the inspection will be conducted against these more stringent limits

Critical limits normally include measurements such as temperature time moisture level pH aw available chlorine and sensory attributes When applicable compare the critical limits found the establishment HACCP plan to those considered standard industry practice

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For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

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upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

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8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 37 of 45 Rev 0

81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 39 of 45 Rev 0

HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 43 of 45 Rev 0

acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

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Page 15: BLANK HACCP STUDY

Stage 4 CONSTRUCTION OF OUR SERVICE FLOW DIAGRAM

851 The HACCP team shall prepare a detailed floe diagram for the specified food services or process categories relevant to the defined scope of the HACCP study

852 The following should be considered when preparing the flow diagram

a) the selection of raw material

b) processing activities

d) processing delays

e) packaging and storage

f) distribution retail and customer handling of the service

g) any outsourced processes and

h) removal of intermediary services by-services and waste

853 A floor plan relevant to the areas falling within the defined scope of the HACCP study shall be prepared The following should be considered during the preparation of the floor plan as relevant technical data for an effective evaluation of the service flow

a) layout and design features of equipment

b) service flow of liquids powders raw and cooked foods

c) routes of personnel and their personal hygiene practices

d) service recycle or rework loops

e) routes of potential cross-contamination through movement of materials

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(ingredients returns water packaging materials etc)

f) segregation of high risk areas from low risk areas where a risk of cross-contamination exists

g) storage and distribution conditions of the different materials used in thefood handling process

h) packaging materials used and

I) factory hygiene cleaning and disinfection procedures

Draw up the Commodity Flow Diagram ( CFD )

The first function of the team is to draw up a detailed commodity flow diagram (CFD) of the commodity system or that part of it which is relevant The expertise of the commodity specialist is important at this stage Commodity systems will differ in detail in different parts of the world and even within one country there may be a number of variants Secondary processing will need to be detailed for each facility using generic flows only as a guide

BLANK FOOD SERVICES ndash COMMODITY FLOW DIAGRAMie How

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NOTE For your information only ndash two EXAMPLES of FOOD SERVICESrsquo FLOW DIAGRAMS

1

2

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Receiving

Cooking CCP

Cutting Preparation

Frozen Storage

Cooking CCP

Refrigerated Storage

Serving

Thawing

Serving

Hot Holding CCP

Cooling CCP

Consumption

Reheating CCP

Consumption

Serving

Slicing

Consumption

Serving

Slicing

Cooling CCP

Serving

Hot Holding CCP

Stage 5 ON-SITE CONFIRMATION OF THE COMMODITY FLOWDIAGRAM

The HACCP team shall confirm the accuracy of the flow diagram and the floor plan on site during all stages and hours of operation so as to ensure that the flow diagram floor plan and technical data as described in 853 gives an accurate representation of the operation The flow diagram shall be amended to take into account any deviation from the original diagram

Records shall be kept

On site confirmation of flow diagram

Upon completion of the CFD members of the team should visit the commodity system (eg farm store or manufacturing area) to compare the information present on the CFD with what actually happens in practice This is known as walking the line a step by step practice to check that all information regarding materials practices controls etc have been taken into consideration by the team during the preparation of the CFD Information such as time of harvest drying procedures storage conditions the marketing chain socio-economic factors grading systems and any incentive for improved quality or safety and processing systems should be collected and included in the CFD as appropriate The site for which the HACCP plan is being designed should be visited as many times as possible to ensure that all relevant information has been collected

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Stage 6 LISTING OF OUR FOOD SAFETY HAZARDS AND MEASURESTO CONTROL THE HAZARD

(Principle 1)

871 The HACCP team shall use the confirmed flow diagram including all the technical data as a guide to identify all the potential food safety hazards (inherent and introduced) that might reasonably be expected to occur at each step of the food handling process Relevant legislation related to the food safety hazards and their control shall be considered The hazards shall be considered in the light of the significance likelihood and severity of such a hazard in terms of the safety of the consumer

872 Control measures for each identified food safety hazard shall be established in order to control such a hazard More than one hazard and control measure might be applicable to one step in the process and more than one control measure might be necessary to control a particular hazard

873 Records shall be kept

Identify and analyse hazard(s)

Effective hazard identification and hazard analysis are the keys to a successful HACCP Plan All real or potential hazards that may occur in each ingredient and at each stage of the commodity system should be considered Food safety hazards for HACCP programmes have been classified into three types of hazards

Biological typically foodborne bacterial pathogens such as Salmonella Listeria and E coli also viruses algae parasites and fungi

Chemical There are three principle types of chemical toxins found in foods naturally occurring chemicals eg cyanides in some root crops and allergenic compounds in peanuts toxins produced by micro-organisms eg mycotoxins

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and algal toxins and chemicals added to the commodity by man to control an identified problem eg fungicides or insecticides

Physical contaminants such as broken glass metal fragments insects or stones

The probability that a hazard will occur is called a risk The risk may take a value from zero to one depending on the degree of certainty that the hazard will be absent or that it will be present After hazard identification a hazard analysis must be conducted to understand the relative health risk to man or animal posed by the hazard It is a way of organizing and analyzing the available scientific information on the nature and size of the health risk associated with the hazard The risk may have to be assessed subjectively and simply classified as low medium or high Only those hazards considered by the HACCP team to present an unacceptable risk of being present are taken forward to Stage 7 Principle 2

Once a food safety hazard has been identified then appropriate control measures should be considered These are any action or activity that can be used to control the identified hazard such that it is prevented eliminated or reduced to an acceptable level The control measure may also include training of personnel for a particular operation covered by Good Manufacturing Processes ( GMP)

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

To identify all biological chemical physical and allergen hazards associated with the purchasing delivering storing usage and sale of BLANKrsquos services

Biological Hazards

The following biological hazards were covered by the terms of reference of our HACCP study

1 Yeast amp Moulds2 Coliforms3 E coli4 Listeria5 Salmonella6 Enterobacteriaceae7 Aerobic Mesophile8 Salmonella spp

Chemical Hazards

The following chemical hazards were covered by the terms of reference of our HACCP study

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1 Cleaning residues2 Printing inks lacquers from packaging3 Chemical contaminants and residues in raw materials

Physical Hazards

The following physical hazards were covered by the terms of reference of our HACCP study

1 Metal2 Glass3 Hair4 Wooden splinters5 Dust dirt particles6 Plastic7 Insects

Allergen Hazards

All the following common allergens were considered as part of our HACCP study

1 Milk2 Egg3 Nuts4 Soya5 Gluten6 Crustaceans7 Fish8 Peanuts9 Celery10 Mustard11 Sesame Seeds12 Sulphites13 Lupin14 Molluscs and products thereof

CHEMICALS USED IN FOOD PROCESSINGPoint of use Type of chemicalGrowing crops Pesticides herbicides defoliants Raising livestock Growth hormones antibiotics Production Food additives processing aids Plant maintenance

Lubricants paints solvents

Plant sanitation Cleaners sanitizing agents pesticides

SOME FOOD-BORNE BIOLOGICAL HAZARDS

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Bacteria Parasites Seafood toxinsAeromonas hydrophila

Anisakis spp Ciguatera fish poisoning

Bacillus cereus Ascaris lumbricoides Gempylotoxin Brucella spp Cyclospora

cayetanensisTetrodotoxin

Campylobacter jejuni

Cryptosporidium parvum

Scombrotoxin ( histamine )

Clostridium botulinum

Diphyllobothrium spp Paralytic neurotoxic and

Clostridium perfringens

Entamoeba histolytica Diarrhetic shellfish poisoning

Listeria monocytogenes

Giardia lamblia

Pathogenic Escherichia coli

Taenia spp

Plesiomonas shigelloides

Viruses

Salmonella spp Hepatitis A virusShigella spp Mycotoxigenic moulds PoliovirusesStaphylococcus aureus

Aspergillus spp Norwalk virus group

Streptococcus pyogenes

Fusarium spp

Vibrio cholera Penicillium sppV parahaemolyticusV vulnificusYersinia enterocolitica

EXAMPLES OF PHYSICAL HAZARDS amp THEIR SOURCESPhysical hazard

Source

Metal Bolts nuts screws screens sieves steel woolGlass Light bulbs watch crystals thermometers etcWood splinters Pallets equipment bracing overhead structureInsects Environment electrocution traps incoming ingredients Hair Meat ingredients employees clothing rodentsMould Poor sanitation inadequate cleaning of equipmentRodents droppings

Inadequate rodent controls incoming ingredients

Dirt rocks Raw materials poor employee practices Paint flakes Equipment overhead structureBand-aid Poor employee practicesPen caps Poor employee practicesCarcass ID tags Slaughterhouse

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Hypodermic needles

Veterinarian

Bullets shot BBs

Animals shot while in fields

Feathers Poor sanitation inadequate pest ( bird ) controls Gasket material Inadequate preventive maintenance of equipment Grease Poor equipment maintenance programme

NB Please refer to the generic Hazard Analysis Questionnaire ( under CHECKLISTS ) ndash this checklist is for PER PRODUCT USED

INFO can also be obtained from the productsrsquo MSDS ( MATERIAL SAFETY DATASHEET ) AND OR The Productsrsquo Ingredients Listing

EXAMPLE 1 OF HACCP DECISION TREE

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Q1 Does this step involve a hazard of sufficient likelihood of occurrence and severity to warrant its control

Q3 Is control at this step necessary to prevent eliminate or reduce the risk of hazard to consumers

Modify step process or product

Yes

Is control at this step necessary for safety

Q2 Does a control measure for the hazard exist at this step

Yes

Yes

Yes

No

No

No

No

Not a CCP

This is a critical control point

Not a CCP

Not a CCP

EXAMPLE 2 OF HACCP DECISION TREE

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Q2 Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level

No

Yes

Q1 Do control measure(s) exist for the identified hazard

Modify step process or product

Q4 Will a subsequent step prior to consuming the food eliminate the identified hazard(s) or reduce the likely occurrence to an acceptable level

Q3 Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable level(s)

Yes

Yes

Yes

Yes

No

No

No

Is control at this step necessary for safety

Not a CCP

Not a CCP

This is a critical control point

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

Biological Hazards123456789101112131415

Chemical Hazards123456789101112131415

Physical Hazards12

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 25 of 45 Rev 0

3

456789101112131415

Allergen Hazards123456789101112131415

Stage 7 DETERMINING CRITICAL CONTROL POINT (CCPS) (DECISION TREE)

(Principle 2)

The HACCP team shall determine whether a particular step in the food handling process is a CCP

The method by which a CCP is determined shall be recorder

NOTE The decision tree in annex B can be as a guideline

INTRODUCTION

A Critical Control Point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level

If a hazard has been identified at a step where control is necessary for safety and no control measure exists at that step or any other then the product or process should be modified at that step or at any earlier or later stage to include a control measure

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 26 of 45 Rev 0

Determine the Critical Control Points (CCPs)

Each step in the commodity flow diagram within the scope of the HACCP study should be taken in turn and the relevance of each identified hazard should be considered It is also important to remember the stated scope of the HACCP analysis at this stage The team must determine whether the hazard can occur at this step and if so whether control measures exist If the hazard can be controlled adequately and is not best controlled at another step and is essential for food safety then this step is a CCP for the specified hazard A decision tree can be used to determine CCPs However the HACCP teams judgement expertise and knowledge of the process are the major factors in establishing CCPs

If a step is identified where a food safety hazard exists but no adequate control measures can be put in place either at this step or subsequently then the product is unsafe for human consumption Production should cease until control measures are available and a CCP can be introduced

The proper identification of Critical Control Points (CCPs) is crucial to the ultimate effectiveness of a HACCP plan The plan must specify where each identified hazard will be controlled

Hazards that cannot be controlled by the operator must be identified on the HACCP plan The plan must indicate how these hazards will be addressed outside the establishment (ie purchasing pre-frozen fish where the supplier is responsible for the freezing requirements as specified by regulation)

Note The evaluation for completeness of the written CCPs will ensure that all relevant information dealing with critical limits monitoring corrective actions verification procedures and record keeping is specified for each identified hazard

D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S ( C C P S )( C C P S ) (HACCP principle 2)

The determination of a CCP in the HACCP system shall be facilitated using a decision tree ndash as is shown in the following diagram

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 27 of 45 Rev 0

HACCP concept element Application step amp principle

Define the food and the processes involved in production

Break down the process into steps

Determine possible hazards associated with each step and probability of hazard persistence in end product if no affective preventive measures are implemented

Specify control measures

Consequently determine critical control points ( CCPs )

Establish critical limits

Monitor CCPs to ensure proper implementation of control measures

Take corrective action when parameter monitoring indicates failure of control measure

HACCP principles 4 and 5

Application steps 9-10

HACCP principles 2 and 3

Application steps 7-8

HACCP principle 1

Application step 6

Application steps 1-5

System to be reviewed confirmed and audited

Records must be generated for the system to be documented

HACCP principles 6 and 7

Application steps 11-12

Stage 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP (Principle 3)

The HACCP team shall establish specific and measurable critical limits appropriate for each CCP Critical limits that can be measured quickly and easily shall be used Measurements can include sensory examination mass measurements temperature measurements time moisture level PH value and chemical analysis

Records shall be kept

Establish critical limits for each CCP

Critical limits must be specified and validated for each CCP Criteria often used include measurements of temperature time moisture level pH water activity and sensory parameters such as visual appearance In the case of mycotoxins for example they may include the moisture content or the temperature of the commodity All critical limits and the associated permissible tolerances must be documented in the HACCP Plan Worksheet and included as specifications in operating procedures and work instructions

ie Critical limits have to be established for all critical components associated with each hazard that is controlled by a CCP

Critical Limits must meet or exceed relevant regulatory and program requirements Some establishments set critical limits to exceed regulatory requirements This is acceptable but the establishment should be made aware that if these limits are the ones written into the HACCP plan the inspection will be conducted against these more stringent limits

Critical limits normally include measurements such as temperature time moisture level pH aw available chlorine and sensory attributes When applicable compare the critical limits found the establishment HACCP plan to those considered standard industry practice

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For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

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upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

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8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 34 of 45 Rev 0

NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 35 of 45 Rev 0

found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

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81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 43 of 45 Rev 0

acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 45 of 45 Rev 0

Page 16: BLANK HACCP STUDY

(ingredients returns water packaging materials etc)

f) segregation of high risk areas from low risk areas where a risk of cross-contamination exists

g) storage and distribution conditions of the different materials used in thefood handling process

h) packaging materials used and

I) factory hygiene cleaning and disinfection procedures

Draw up the Commodity Flow Diagram ( CFD )

The first function of the team is to draw up a detailed commodity flow diagram (CFD) of the commodity system or that part of it which is relevant The expertise of the commodity specialist is important at this stage Commodity systems will differ in detail in different parts of the world and even within one country there may be a number of variants Secondary processing will need to be detailed for each facility using generic flows only as a guide

BLANK FOOD SERVICES ndash COMMODITY FLOW DIAGRAMie How

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NOTE For your information only ndash two EXAMPLES of FOOD SERVICESrsquo FLOW DIAGRAMS

1

2

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 17 of 45 Rev 0

Receiving

Cooking CCP

Cutting Preparation

Frozen Storage

Cooking CCP

Refrigerated Storage

Serving

Thawing

Serving

Hot Holding CCP

Cooling CCP

Consumption

Reheating CCP

Consumption

Serving

Slicing

Consumption

Serving

Slicing

Cooling CCP

Serving

Hot Holding CCP

Stage 5 ON-SITE CONFIRMATION OF THE COMMODITY FLOWDIAGRAM

The HACCP team shall confirm the accuracy of the flow diagram and the floor plan on site during all stages and hours of operation so as to ensure that the flow diagram floor plan and technical data as described in 853 gives an accurate representation of the operation The flow diagram shall be amended to take into account any deviation from the original diagram

Records shall be kept

On site confirmation of flow diagram

Upon completion of the CFD members of the team should visit the commodity system (eg farm store or manufacturing area) to compare the information present on the CFD with what actually happens in practice This is known as walking the line a step by step practice to check that all information regarding materials practices controls etc have been taken into consideration by the team during the preparation of the CFD Information such as time of harvest drying procedures storage conditions the marketing chain socio-economic factors grading systems and any incentive for improved quality or safety and processing systems should be collected and included in the CFD as appropriate The site for which the HACCP plan is being designed should be visited as many times as possible to ensure that all relevant information has been collected

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Stage 6 LISTING OF OUR FOOD SAFETY HAZARDS AND MEASURESTO CONTROL THE HAZARD

(Principle 1)

871 The HACCP team shall use the confirmed flow diagram including all the technical data as a guide to identify all the potential food safety hazards (inherent and introduced) that might reasonably be expected to occur at each step of the food handling process Relevant legislation related to the food safety hazards and their control shall be considered The hazards shall be considered in the light of the significance likelihood and severity of such a hazard in terms of the safety of the consumer

872 Control measures for each identified food safety hazard shall be established in order to control such a hazard More than one hazard and control measure might be applicable to one step in the process and more than one control measure might be necessary to control a particular hazard

873 Records shall be kept

Identify and analyse hazard(s)

Effective hazard identification and hazard analysis are the keys to a successful HACCP Plan All real or potential hazards that may occur in each ingredient and at each stage of the commodity system should be considered Food safety hazards for HACCP programmes have been classified into three types of hazards

Biological typically foodborne bacterial pathogens such as Salmonella Listeria and E coli also viruses algae parasites and fungi

Chemical There are three principle types of chemical toxins found in foods naturally occurring chemicals eg cyanides in some root crops and allergenic compounds in peanuts toxins produced by micro-organisms eg mycotoxins

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and algal toxins and chemicals added to the commodity by man to control an identified problem eg fungicides or insecticides

Physical contaminants such as broken glass metal fragments insects or stones

The probability that a hazard will occur is called a risk The risk may take a value from zero to one depending on the degree of certainty that the hazard will be absent or that it will be present After hazard identification a hazard analysis must be conducted to understand the relative health risk to man or animal posed by the hazard It is a way of organizing and analyzing the available scientific information on the nature and size of the health risk associated with the hazard The risk may have to be assessed subjectively and simply classified as low medium or high Only those hazards considered by the HACCP team to present an unacceptable risk of being present are taken forward to Stage 7 Principle 2

Once a food safety hazard has been identified then appropriate control measures should be considered These are any action or activity that can be used to control the identified hazard such that it is prevented eliminated or reduced to an acceptable level The control measure may also include training of personnel for a particular operation covered by Good Manufacturing Processes ( GMP)

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

To identify all biological chemical physical and allergen hazards associated with the purchasing delivering storing usage and sale of BLANKrsquos services

Biological Hazards

The following biological hazards were covered by the terms of reference of our HACCP study

1 Yeast amp Moulds2 Coliforms3 E coli4 Listeria5 Salmonella6 Enterobacteriaceae7 Aerobic Mesophile8 Salmonella spp

Chemical Hazards

The following chemical hazards were covered by the terms of reference of our HACCP study

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1 Cleaning residues2 Printing inks lacquers from packaging3 Chemical contaminants and residues in raw materials

Physical Hazards

The following physical hazards were covered by the terms of reference of our HACCP study

1 Metal2 Glass3 Hair4 Wooden splinters5 Dust dirt particles6 Plastic7 Insects

Allergen Hazards

All the following common allergens were considered as part of our HACCP study

1 Milk2 Egg3 Nuts4 Soya5 Gluten6 Crustaceans7 Fish8 Peanuts9 Celery10 Mustard11 Sesame Seeds12 Sulphites13 Lupin14 Molluscs and products thereof

CHEMICALS USED IN FOOD PROCESSINGPoint of use Type of chemicalGrowing crops Pesticides herbicides defoliants Raising livestock Growth hormones antibiotics Production Food additives processing aids Plant maintenance

Lubricants paints solvents

Plant sanitation Cleaners sanitizing agents pesticides

SOME FOOD-BORNE BIOLOGICAL HAZARDS

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Bacteria Parasites Seafood toxinsAeromonas hydrophila

Anisakis spp Ciguatera fish poisoning

Bacillus cereus Ascaris lumbricoides Gempylotoxin Brucella spp Cyclospora

cayetanensisTetrodotoxin

Campylobacter jejuni

Cryptosporidium parvum

Scombrotoxin ( histamine )

Clostridium botulinum

Diphyllobothrium spp Paralytic neurotoxic and

Clostridium perfringens

Entamoeba histolytica Diarrhetic shellfish poisoning

Listeria monocytogenes

Giardia lamblia

Pathogenic Escherichia coli

Taenia spp

Plesiomonas shigelloides

Viruses

Salmonella spp Hepatitis A virusShigella spp Mycotoxigenic moulds PoliovirusesStaphylococcus aureus

Aspergillus spp Norwalk virus group

Streptococcus pyogenes

Fusarium spp

Vibrio cholera Penicillium sppV parahaemolyticusV vulnificusYersinia enterocolitica

EXAMPLES OF PHYSICAL HAZARDS amp THEIR SOURCESPhysical hazard

Source

Metal Bolts nuts screws screens sieves steel woolGlass Light bulbs watch crystals thermometers etcWood splinters Pallets equipment bracing overhead structureInsects Environment electrocution traps incoming ingredients Hair Meat ingredients employees clothing rodentsMould Poor sanitation inadequate cleaning of equipmentRodents droppings

Inadequate rodent controls incoming ingredients

Dirt rocks Raw materials poor employee practices Paint flakes Equipment overhead structureBand-aid Poor employee practicesPen caps Poor employee practicesCarcass ID tags Slaughterhouse

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Hypodermic needles

Veterinarian

Bullets shot BBs

Animals shot while in fields

Feathers Poor sanitation inadequate pest ( bird ) controls Gasket material Inadequate preventive maintenance of equipment Grease Poor equipment maintenance programme

NB Please refer to the generic Hazard Analysis Questionnaire ( under CHECKLISTS ) ndash this checklist is for PER PRODUCT USED

INFO can also be obtained from the productsrsquo MSDS ( MATERIAL SAFETY DATASHEET ) AND OR The Productsrsquo Ingredients Listing

EXAMPLE 1 OF HACCP DECISION TREE

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Q1 Does this step involve a hazard of sufficient likelihood of occurrence and severity to warrant its control

Q3 Is control at this step necessary to prevent eliminate or reduce the risk of hazard to consumers

Modify step process or product

Yes

Is control at this step necessary for safety

Q2 Does a control measure for the hazard exist at this step

Yes

Yes

Yes

No

No

No

No

Not a CCP

This is a critical control point

Not a CCP

Not a CCP

EXAMPLE 2 OF HACCP DECISION TREE

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Q2 Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level

No

Yes

Q1 Do control measure(s) exist for the identified hazard

Modify step process or product

Q4 Will a subsequent step prior to consuming the food eliminate the identified hazard(s) or reduce the likely occurrence to an acceptable level

Q3 Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable level(s)

Yes

Yes

Yes

Yes

No

No

No

Is control at this step necessary for safety

Not a CCP

Not a CCP

This is a critical control point

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

Biological Hazards123456789101112131415

Chemical Hazards123456789101112131415

Physical Hazards12

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 25 of 45 Rev 0

3

456789101112131415

Allergen Hazards123456789101112131415

Stage 7 DETERMINING CRITICAL CONTROL POINT (CCPS) (DECISION TREE)

(Principle 2)

The HACCP team shall determine whether a particular step in the food handling process is a CCP

The method by which a CCP is determined shall be recorder

NOTE The decision tree in annex B can be as a guideline

INTRODUCTION

A Critical Control Point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level

If a hazard has been identified at a step where control is necessary for safety and no control measure exists at that step or any other then the product or process should be modified at that step or at any earlier or later stage to include a control measure

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 26 of 45 Rev 0

Determine the Critical Control Points (CCPs)

Each step in the commodity flow diagram within the scope of the HACCP study should be taken in turn and the relevance of each identified hazard should be considered It is also important to remember the stated scope of the HACCP analysis at this stage The team must determine whether the hazard can occur at this step and if so whether control measures exist If the hazard can be controlled adequately and is not best controlled at another step and is essential for food safety then this step is a CCP for the specified hazard A decision tree can be used to determine CCPs However the HACCP teams judgement expertise and knowledge of the process are the major factors in establishing CCPs

If a step is identified where a food safety hazard exists but no adequate control measures can be put in place either at this step or subsequently then the product is unsafe for human consumption Production should cease until control measures are available and a CCP can be introduced

The proper identification of Critical Control Points (CCPs) is crucial to the ultimate effectiveness of a HACCP plan The plan must specify where each identified hazard will be controlled

Hazards that cannot be controlled by the operator must be identified on the HACCP plan The plan must indicate how these hazards will be addressed outside the establishment (ie purchasing pre-frozen fish where the supplier is responsible for the freezing requirements as specified by regulation)

Note The evaluation for completeness of the written CCPs will ensure that all relevant information dealing with critical limits monitoring corrective actions verification procedures and record keeping is specified for each identified hazard

D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S ( C C P S )( C C P S ) (HACCP principle 2)

The determination of a CCP in the HACCP system shall be facilitated using a decision tree ndash as is shown in the following diagram

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 27 of 45 Rev 0

HACCP concept element Application step amp principle

Define the food and the processes involved in production

Break down the process into steps

Determine possible hazards associated with each step and probability of hazard persistence in end product if no affective preventive measures are implemented

Specify control measures

Consequently determine critical control points ( CCPs )

Establish critical limits

Monitor CCPs to ensure proper implementation of control measures

Take corrective action when parameter monitoring indicates failure of control measure

HACCP principles 4 and 5

Application steps 9-10

HACCP principles 2 and 3

Application steps 7-8

HACCP principle 1

Application step 6

Application steps 1-5

System to be reviewed confirmed and audited

Records must be generated for the system to be documented

HACCP principles 6 and 7

Application steps 11-12

Stage 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP (Principle 3)

The HACCP team shall establish specific and measurable critical limits appropriate for each CCP Critical limits that can be measured quickly and easily shall be used Measurements can include sensory examination mass measurements temperature measurements time moisture level PH value and chemical analysis

Records shall be kept

Establish critical limits for each CCP

Critical limits must be specified and validated for each CCP Criteria often used include measurements of temperature time moisture level pH water activity and sensory parameters such as visual appearance In the case of mycotoxins for example they may include the moisture content or the temperature of the commodity All critical limits and the associated permissible tolerances must be documented in the HACCP Plan Worksheet and included as specifications in operating procedures and work instructions

ie Critical limits have to be established for all critical components associated with each hazard that is controlled by a CCP

Critical Limits must meet or exceed relevant regulatory and program requirements Some establishments set critical limits to exceed regulatory requirements This is acceptable but the establishment should be made aware that if these limits are the ones written into the HACCP plan the inspection will be conducted against these more stringent limits

Critical limits normally include measurements such as temperature time moisture level pH aw available chlorine and sensory attributes When applicable compare the critical limits found the establishment HACCP plan to those considered standard industry practice

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For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

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upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

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8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

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81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

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acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

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Page 17: BLANK HACCP STUDY

NOTE For your information only ndash two EXAMPLES of FOOD SERVICESrsquo FLOW DIAGRAMS

1

2

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Receiving

Cooking CCP

Cutting Preparation

Frozen Storage

Cooking CCP

Refrigerated Storage

Serving

Thawing

Serving

Hot Holding CCP

Cooling CCP

Consumption

Reheating CCP

Consumption

Serving

Slicing

Consumption

Serving

Slicing

Cooling CCP

Serving

Hot Holding CCP

Stage 5 ON-SITE CONFIRMATION OF THE COMMODITY FLOWDIAGRAM

The HACCP team shall confirm the accuracy of the flow diagram and the floor plan on site during all stages and hours of operation so as to ensure that the flow diagram floor plan and technical data as described in 853 gives an accurate representation of the operation The flow diagram shall be amended to take into account any deviation from the original diagram

Records shall be kept

On site confirmation of flow diagram

Upon completion of the CFD members of the team should visit the commodity system (eg farm store or manufacturing area) to compare the information present on the CFD with what actually happens in practice This is known as walking the line a step by step practice to check that all information regarding materials practices controls etc have been taken into consideration by the team during the preparation of the CFD Information such as time of harvest drying procedures storage conditions the marketing chain socio-economic factors grading systems and any incentive for improved quality or safety and processing systems should be collected and included in the CFD as appropriate The site for which the HACCP plan is being designed should be visited as many times as possible to ensure that all relevant information has been collected

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Stage 6 LISTING OF OUR FOOD SAFETY HAZARDS AND MEASURESTO CONTROL THE HAZARD

(Principle 1)

871 The HACCP team shall use the confirmed flow diagram including all the technical data as a guide to identify all the potential food safety hazards (inherent and introduced) that might reasonably be expected to occur at each step of the food handling process Relevant legislation related to the food safety hazards and their control shall be considered The hazards shall be considered in the light of the significance likelihood and severity of such a hazard in terms of the safety of the consumer

872 Control measures for each identified food safety hazard shall be established in order to control such a hazard More than one hazard and control measure might be applicable to one step in the process and more than one control measure might be necessary to control a particular hazard

873 Records shall be kept

Identify and analyse hazard(s)

Effective hazard identification and hazard analysis are the keys to a successful HACCP Plan All real or potential hazards that may occur in each ingredient and at each stage of the commodity system should be considered Food safety hazards for HACCP programmes have been classified into three types of hazards

Biological typically foodborne bacterial pathogens such as Salmonella Listeria and E coli also viruses algae parasites and fungi

Chemical There are three principle types of chemical toxins found in foods naturally occurring chemicals eg cyanides in some root crops and allergenic compounds in peanuts toxins produced by micro-organisms eg mycotoxins

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and algal toxins and chemicals added to the commodity by man to control an identified problem eg fungicides or insecticides

Physical contaminants such as broken glass metal fragments insects or stones

The probability that a hazard will occur is called a risk The risk may take a value from zero to one depending on the degree of certainty that the hazard will be absent or that it will be present After hazard identification a hazard analysis must be conducted to understand the relative health risk to man or animal posed by the hazard It is a way of organizing and analyzing the available scientific information on the nature and size of the health risk associated with the hazard The risk may have to be assessed subjectively and simply classified as low medium or high Only those hazards considered by the HACCP team to present an unacceptable risk of being present are taken forward to Stage 7 Principle 2

Once a food safety hazard has been identified then appropriate control measures should be considered These are any action or activity that can be used to control the identified hazard such that it is prevented eliminated or reduced to an acceptable level The control measure may also include training of personnel for a particular operation covered by Good Manufacturing Processes ( GMP)

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

To identify all biological chemical physical and allergen hazards associated with the purchasing delivering storing usage and sale of BLANKrsquos services

Biological Hazards

The following biological hazards were covered by the terms of reference of our HACCP study

1 Yeast amp Moulds2 Coliforms3 E coli4 Listeria5 Salmonella6 Enterobacteriaceae7 Aerobic Mesophile8 Salmonella spp

Chemical Hazards

The following chemical hazards were covered by the terms of reference of our HACCP study

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1 Cleaning residues2 Printing inks lacquers from packaging3 Chemical contaminants and residues in raw materials

Physical Hazards

The following physical hazards were covered by the terms of reference of our HACCP study

1 Metal2 Glass3 Hair4 Wooden splinters5 Dust dirt particles6 Plastic7 Insects

Allergen Hazards

All the following common allergens were considered as part of our HACCP study

1 Milk2 Egg3 Nuts4 Soya5 Gluten6 Crustaceans7 Fish8 Peanuts9 Celery10 Mustard11 Sesame Seeds12 Sulphites13 Lupin14 Molluscs and products thereof

CHEMICALS USED IN FOOD PROCESSINGPoint of use Type of chemicalGrowing crops Pesticides herbicides defoliants Raising livestock Growth hormones antibiotics Production Food additives processing aids Plant maintenance

Lubricants paints solvents

Plant sanitation Cleaners sanitizing agents pesticides

SOME FOOD-BORNE BIOLOGICAL HAZARDS

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Bacteria Parasites Seafood toxinsAeromonas hydrophila

Anisakis spp Ciguatera fish poisoning

Bacillus cereus Ascaris lumbricoides Gempylotoxin Brucella spp Cyclospora

cayetanensisTetrodotoxin

Campylobacter jejuni

Cryptosporidium parvum

Scombrotoxin ( histamine )

Clostridium botulinum

Diphyllobothrium spp Paralytic neurotoxic and

Clostridium perfringens

Entamoeba histolytica Diarrhetic shellfish poisoning

Listeria monocytogenes

Giardia lamblia

Pathogenic Escherichia coli

Taenia spp

Plesiomonas shigelloides

Viruses

Salmonella spp Hepatitis A virusShigella spp Mycotoxigenic moulds PoliovirusesStaphylococcus aureus

Aspergillus spp Norwalk virus group

Streptococcus pyogenes

Fusarium spp

Vibrio cholera Penicillium sppV parahaemolyticusV vulnificusYersinia enterocolitica

EXAMPLES OF PHYSICAL HAZARDS amp THEIR SOURCESPhysical hazard

Source

Metal Bolts nuts screws screens sieves steel woolGlass Light bulbs watch crystals thermometers etcWood splinters Pallets equipment bracing overhead structureInsects Environment electrocution traps incoming ingredients Hair Meat ingredients employees clothing rodentsMould Poor sanitation inadequate cleaning of equipmentRodents droppings

Inadequate rodent controls incoming ingredients

Dirt rocks Raw materials poor employee practices Paint flakes Equipment overhead structureBand-aid Poor employee practicesPen caps Poor employee practicesCarcass ID tags Slaughterhouse

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Hypodermic needles

Veterinarian

Bullets shot BBs

Animals shot while in fields

Feathers Poor sanitation inadequate pest ( bird ) controls Gasket material Inadequate preventive maintenance of equipment Grease Poor equipment maintenance programme

NB Please refer to the generic Hazard Analysis Questionnaire ( under CHECKLISTS ) ndash this checklist is for PER PRODUCT USED

INFO can also be obtained from the productsrsquo MSDS ( MATERIAL SAFETY DATASHEET ) AND OR The Productsrsquo Ingredients Listing

EXAMPLE 1 OF HACCP DECISION TREE

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Q1 Does this step involve a hazard of sufficient likelihood of occurrence and severity to warrant its control

Q3 Is control at this step necessary to prevent eliminate or reduce the risk of hazard to consumers

Modify step process or product

Yes

Is control at this step necessary for safety

Q2 Does a control measure for the hazard exist at this step

Yes

Yes

Yes

No

No

No

No

Not a CCP

This is a critical control point

Not a CCP

Not a CCP

EXAMPLE 2 OF HACCP DECISION TREE

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Q2 Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level

No

Yes

Q1 Do control measure(s) exist for the identified hazard

Modify step process or product

Q4 Will a subsequent step prior to consuming the food eliminate the identified hazard(s) or reduce the likely occurrence to an acceptable level

Q3 Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable level(s)

Yes

Yes

Yes

Yes

No

No

No

Is control at this step necessary for safety

Not a CCP

Not a CCP

This is a critical control point

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

Biological Hazards123456789101112131415

Chemical Hazards123456789101112131415

Physical Hazards12

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 25 of 45 Rev 0

3

456789101112131415

Allergen Hazards123456789101112131415

Stage 7 DETERMINING CRITICAL CONTROL POINT (CCPS) (DECISION TREE)

(Principle 2)

The HACCP team shall determine whether a particular step in the food handling process is a CCP

The method by which a CCP is determined shall be recorder

NOTE The decision tree in annex B can be as a guideline

INTRODUCTION

A Critical Control Point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level

If a hazard has been identified at a step where control is necessary for safety and no control measure exists at that step or any other then the product or process should be modified at that step or at any earlier or later stage to include a control measure

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Determine the Critical Control Points (CCPs)

Each step in the commodity flow diagram within the scope of the HACCP study should be taken in turn and the relevance of each identified hazard should be considered It is also important to remember the stated scope of the HACCP analysis at this stage The team must determine whether the hazard can occur at this step and if so whether control measures exist If the hazard can be controlled adequately and is not best controlled at another step and is essential for food safety then this step is a CCP for the specified hazard A decision tree can be used to determine CCPs However the HACCP teams judgement expertise and knowledge of the process are the major factors in establishing CCPs

If a step is identified where a food safety hazard exists but no adequate control measures can be put in place either at this step or subsequently then the product is unsafe for human consumption Production should cease until control measures are available and a CCP can be introduced

The proper identification of Critical Control Points (CCPs) is crucial to the ultimate effectiveness of a HACCP plan The plan must specify where each identified hazard will be controlled

Hazards that cannot be controlled by the operator must be identified on the HACCP plan The plan must indicate how these hazards will be addressed outside the establishment (ie purchasing pre-frozen fish where the supplier is responsible for the freezing requirements as specified by regulation)

Note The evaluation for completeness of the written CCPs will ensure that all relevant information dealing with critical limits monitoring corrective actions verification procedures and record keeping is specified for each identified hazard

D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S ( C C P S )( C C P S ) (HACCP principle 2)

The determination of a CCP in the HACCP system shall be facilitated using a decision tree ndash as is shown in the following diagram

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HACCP concept element Application step amp principle

Define the food and the processes involved in production

Break down the process into steps

Determine possible hazards associated with each step and probability of hazard persistence in end product if no affective preventive measures are implemented

Specify control measures

Consequently determine critical control points ( CCPs )

Establish critical limits

Monitor CCPs to ensure proper implementation of control measures

Take corrective action when parameter monitoring indicates failure of control measure

HACCP principles 4 and 5

Application steps 9-10

HACCP principles 2 and 3

Application steps 7-8

HACCP principle 1

Application step 6

Application steps 1-5

System to be reviewed confirmed and audited

Records must be generated for the system to be documented

HACCP principles 6 and 7

Application steps 11-12

Stage 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP (Principle 3)

The HACCP team shall establish specific and measurable critical limits appropriate for each CCP Critical limits that can be measured quickly and easily shall be used Measurements can include sensory examination mass measurements temperature measurements time moisture level PH value and chemical analysis

Records shall be kept

Establish critical limits for each CCP

Critical limits must be specified and validated for each CCP Criteria often used include measurements of temperature time moisture level pH water activity and sensory parameters such as visual appearance In the case of mycotoxins for example they may include the moisture content or the temperature of the commodity All critical limits and the associated permissible tolerances must be documented in the HACCP Plan Worksheet and included as specifications in operating procedures and work instructions

ie Critical limits have to be established for all critical components associated with each hazard that is controlled by a CCP

Critical Limits must meet or exceed relevant regulatory and program requirements Some establishments set critical limits to exceed regulatory requirements This is acceptable but the establishment should be made aware that if these limits are the ones written into the HACCP plan the inspection will be conducted against these more stringent limits

Critical limits normally include measurements such as temperature time moisture level pH aw available chlorine and sensory attributes When applicable compare the critical limits found the establishment HACCP plan to those considered standard industry practice

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For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

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upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

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8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

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81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

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acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 45 of 45 Rev 0

Page 18: BLANK HACCP STUDY

Stage 5 ON-SITE CONFIRMATION OF THE COMMODITY FLOWDIAGRAM

The HACCP team shall confirm the accuracy of the flow diagram and the floor plan on site during all stages and hours of operation so as to ensure that the flow diagram floor plan and technical data as described in 853 gives an accurate representation of the operation The flow diagram shall be amended to take into account any deviation from the original diagram

Records shall be kept

On site confirmation of flow diagram

Upon completion of the CFD members of the team should visit the commodity system (eg farm store or manufacturing area) to compare the information present on the CFD with what actually happens in practice This is known as walking the line a step by step practice to check that all information regarding materials practices controls etc have been taken into consideration by the team during the preparation of the CFD Information such as time of harvest drying procedures storage conditions the marketing chain socio-economic factors grading systems and any incentive for improved quality or safety and processing systems should be collected and included in the CFD as appropriate The site for which the HACCP plan is being designed should be visited as many times as possible to ensure that all relevant information has been collected

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Stage 6 LISTING OF OUR FOOD SAFETY HAZARDS AND MEASURESTO CONTROL THE HAZARD

(Principle 1)

871 The HACCP team shall use the confirmed flow diagram including all the technical data as a guide to identify all the potential food safety hazards (inherent and introduced) that might reasonably be expected to occur at each step of the food handling process Relevant legislation related to the food safety hazards and their control shall be considered The hazards shall be considered in the light of the significance likelihood and severity of such a hazard in terms of the safety of the consumer

872 Control measures for each identified food safety hazard shall be established in order to control such a hazard More than one hazard and control measure might be applicable to one step in the process and more than one control measure might be necessary to control a particular hazard

873 Records shall be kept

Identify and analyse hazard(s)

Effective hazard identification and hazard analysis are the keys to a successful HACCP Plan All real or potential hazards that may occur in each ingredient and at each stage of the commodity system should be considered Food safety hazards for HACCP programmes have been classified into three types of hazards

Biological typically foodborne bacterial pathogens such as Salmonella Listeria and E coli also viruses algae parasites and fungi

Chemical There are three principle types of chemical toxins found in foods naturally occurring chemicals eg cyanides in some root crops and allergenic compounds in peanuts toxins produced by micro-organisms eg mycotoxins

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and algal toxins and chemicals added to the commodity by man to control an identified problem eg fungicides or insecticides

Physical contaminants such as broken glass metal fragments insects or stones

The probability that a hazard will occur is called a risk The risk may take a value from zero to one depending on the degree of certainty that the hazard will be absent or that it will be present After hazard identification a hazard analysis must be conducted to understand the relative health risk to man or animal posed by the hazard It is a way of organizing and analyzing the available scientific information on the nature and size of the health risk associated with the hazard The risk may have to be assessed subjectively and simply classified as low medium or high Only those hazards considered by the HACCP team to present an unacceptable risk of being present are taken forward to Stage 7 Principle 2

Once a food safety hazard has been identified then appropriate control measures should be considered These are any action or activity that can be used to control the identified hazard such that it is prevented eliminated or reduced to an acceptable level The control measure may also include training of personnel for a particular operation covered by Good Manufacturing Processes ( GMP)

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

To identify all biological chemical physical and allergen hazards associated with the purchasing delivering storing usage and sale of BLANKrsquos services

Biological Hazards

The following biological hazards were covered by the terms of reference of our HACCP study

1 Yeast amp Moulds2 Coliforms3 E coli4 Listeria5 Salmonella6 Enterobacteriaceae7 Aerobic Mesophile8 Salmonella spp

Chemical Hazards

The following chemical hazards were covered by the terms of reference of our HACCP study

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 20 of 45 Rev 0

1 Cleaning residues2 Printing inks lacquers from packaging3 Chemical contaminants and residues in raw materials

Physical Hazards

The following physical hazards were covered by the terms of reference of our HACCP study

1 Metal2 Glass3 Hair4 Wooden splinters5 Dust dirt particles6 Plastic7 Insects

Allergen Hazards

All the following common allergens were considered as part of our HACCP study

1 Milk2 Egg3 Nuts4 Soya5 Gluten6 Crustaceans7 Fish8 Peanuts9 Celery10 Mustard11 Sesame Seeds12 Sulphites13 Lupin14 Molluscs and products thereof

CHEMICALS USED IN FOOD PROCESSINGPoint of use Type of chemicalGrowing crops Pesticides herbicides defoliants Raising livestock Growth hormones antibiotics Production Food additives processing aids Plant maintenance

Lubricants paints solvents

Plant sanitation Cleaners sanitizing agents pesticides

SOME FOOD-BORNE BIOLOGICAL HAZARDS

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 21 of 45 Rev 0

Bacteria Parasites Seafood toxinsAeromonas hydrophila

Anisakis spp Ciguatera fish poisoning

Bacillus cereus Ascaris lumbricoides Gempylotoxin Brucella spp Cyclospora

cayetanensisTetrodotoxin

Campylobacter jejuni

Cryptosporidium parvum

Scombrotoxin ( histamine )

Clostridium botulinum

Diphyllobothrium spp Paralytic neurotoxic and

Clostridium perfringens

Entamoeba histolytica Diarrhetic shellfish poisoning

Listeria monocytogenes

Giardia lamblia

Pathogenic Escherichia coli

Taenia spp

Plesiomonas shigelloides

Viruses

Salmonella spp Hepatitis A virusShigella spp Mycotoxigenic moulds PoliovirusesStaphylococcus aureus

Aspergillus spp Norwalk virus group

Streptococcus pyogenes

Fusarium spp

Vibrio cholera Penicillium sppV parahaemolyticusV vulnificusYersinia enterocolitica

EXAMPLES OF PHYSICAL HAZARDS amp THEIR SOURCESPhysical hazard

Source

Metal Bolts nuts screws screens sieves steel woolGlass Light bulbs watch crystals thermometers etcWood splinters Pallets equipment bracing overhead structureInsects Environment electrocution traps incoming ingredients Hair Meat ingredients employees clothing rodentsMould Poor sanitation inadequate cleaning of equipmentRodents droppings

Inadequate rodent controls incoming ingredients

Dirt rocks Raw materials poor employee practices Paint flakes Equipment overhead structureBand-aid Poor employee practicesPen caps Poor employee practicesCarcass ID tags Slaughterhouse

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 22 of 45 Rev 0

Hypodermic needles

Veterinarian

Bullets shot BBs

Animals shot while in fields

Feathers Poor sanitation inadequate pest ( bird ) controls Gasket material Inadequate preventive maintenance of equipment Grease Poor equipment maintenance programme

NB Please refer to the generic Hazard Analysis Questionnaire ( under CHECKLISTS ) ndash this checklist is for PER PRODUCT USED

INFO can also be obtained from the productsrsquo MSDS ( MATERIAL SAFETY DATASHEET ) AND OR The Productsrsquo Ingredients Listing

EXAMPLE 1 OF HACCP DECISION TREE

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Q1 Does this step involve a hazard of sufficient likelihood of occurrence and severity to warrant its control

Q3 Is control at this step necessary to prevent eliminate or reduce the risk of hazard to consumers

Modify step process or product

Yes

Is control at this step necessary for safety

Q2 Does a control measure for the hazard exist at this step

Yes

Yes

Yes

No

No

No

No

Not a CCP

This is a critical control point

Not a CCP

Not a CCP

EXAMPLE 2 OF HACCP DECISION TREE

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Q2 Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level

No

Yes

Q1 Do control measure(s) exist for the identified hazard

Modify step process or product

Q4 Will a subsequent step prior to consuming the food eliminate the identified hazard(s) or reduce the likely occurrence to an acceptable level

Q3 Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable level(s)

Yes

Yes

Yes

Yes

No

No

No

Is control at this step necessary for safety

Not a CCP

Not a CCP

This is a critical control point

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

Biological Hazards123456789101112131415

Chemical Hazards123456789101112131415

Physical Hazards12

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 25 of 45 Rev 0

3

456789101112131415

Allergen Hazards123456789101112131415

Stage 7 DETERMINING CRITICAL CONTROL POINT (CCPS) (DECISION TREE)

(Principle 2)

The HACCP team shall determine whether a particular step in the food handling process is a CCP

The method by which a CCP is determined shall be recorder

NOTE The decision tree in annex B can be as a guideline

INTRODUCTION

A Critical Control Point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level

If a hazard has been identified at a step where control is necessary for safety and no control measure exists at that step or any other then the product or process should be modified at that step or at any earlier or later stage to include a control measure

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 26 of 45 Rev 0

Determine the Critical Control Points (CCPs)

Each step in the commodity flow diagram within the scope of the HACCP study should be taken in turn and the relevance of each identified hazard should be considered It is also important to remember the stated scope of the HACCP analysis at this stage The team must determine whether the hazard can occur at this step and if so whether control measures exist If the hazard can be controlled adequately and is not best controlled at another step and is essential for food safety then this step is a CCP for the specified hazard A decision tree can be used to determine CCPs However the HACCP teams judgement expertise and knowledge of the process are the major factors in establishing CCPs

If a step is identified where a food safety hazard exists but no adequate control measures can be put in place either at this step or subsequently then the product is unsafe for human consumption Production should cease until control measures are available and a CCP can be introduced

The proper identification of Critical Control Points (CCPs) is crucial to the ultimate effectiveness of a HACCP plan The plan must specify where each identified hazard will be controlled

Hazards that cannot be controlled by the operator must be identified on the HACCP plan The plan must indicate how these hazards will be addressed outside the establishment (ie purchasing pre-frozen fish where the supplier is responsible for the freezing requirements as specified by regulation)

Note The evaluation for completeness of the written CCPs will ensure that all relevant information dealing with critical limits monitoring corrective actions verification procedures and record keeping is specified for each identified hazard

D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S ( C C P S )( C C P S ) (HACCP principle 2)

The determination of a CCP in the HACCP system shall be facilitated using a decision tree ndash as is shown in the following diagram

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 27 of 45 Rev 0

HACCP concept element Application step amp principle

Define the food and the processes involved in production

Break down the process into steps

Determine possible hazards associated with each step and probability of hazard persistence in end product if no affective preventive measures are implemented

Specify control measures

Consequently determine critical control points ( CCPs )

Establish critical limits

Monitor CCPs to ensure proper implementation of control measures

Take corrective action when parameter monitoring indicates failure of control measure

HACCP principles 4 and 5

Application steps 9-10

HACCP principles 2 and 3

Application steps 7-8

HACCP principle 1

Application step 6

Application steps 1-5

System to be reviewed confirmed and audited

Records must be generated for the system to be documented

HACCP principles 6 and 7

Application steps 11-12

Stage 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP (Principle 3)

The HACCP team shall establish specific and measurable critical limits appropriate for each CCP Critical limits that can be measured quickly and easily shall be used Measurements can include sensory examination mass measurements temperature measurements time moisture level PH value and chemical analysis

Records shall be kept

Establish critical limits for each CCP

Critical limits must be specified and validated for each CCP Criteria often used include measurements of temperature time moisture level pH water activity and sensory parameters such as visual appearance In the case of mycotoxins for example they may include the moisture content or the temperature of the commodity All critical limits and the associated permissible tolerances must be documented in the HACCP Plan Worksheet and included as specifications in operating procedures and work instructions

ie Critical limits have to be established for all critical components associated with each hazard that is controlled by a CCP

Critical Limits must meet or exceed relevant regulatory and program requirements Some establishments set critical limits to exceed regulatory requirements This is acceptable but the establishment should be made aware that if these limits are the ones written into the HACCP plan the inspection will be conducted against these more stringent limits

Critical limits normally include measurements such as temperature time moisture level pH aw available chlorine and sensory attributes When applicable compare the critical limits found the establishment HACCP plan to those considered standard industry practice

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For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

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upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

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8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 37 of 45 Rev 0

81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 39 of 45 Rev 0

HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 43 of 45 Rev 0

acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 44 of 45 Rev 0

process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 45 of 45 Rev 0

Page 19: BLANK HACCP STUDY

Stage 6 LISTING OF OUR FOOD SAFETY HAZARDS AND MEASURESTO CONTROL THE HAZARD

(Principle 1)

871 The HACCP team shall use the confirmed flow diagram including all the technical data as a guide to identify all the potential food safety hazards (inherent and introduced) that might reasonably be expected to occur at each step of the food handling process Relevant legislation related to the food safety hazards and their control shall be considered The hazards shall be considered in the light of the significance likelihood and severity of such a hazard in terms of the safety of the consumer

872 Control measures for each identified food safety hazard shall be established in order to control such a hazard More than one hazard and control measure might be applicable to one step in the process and more than one control measure might be necessary to control a particular hazard

873 Records shall be kept

Identify and analyse hazard(s)

Effective hazard identification and hazard analysis are the keys to a successful HACCP Plan All real or potential hazards that may occur in each ingredient and at each stage of the commodity system should be considered Food safety hazards for HACCP programmes have been classified into three types of hazards

Biological typically foodborne bacterial pathogens such as Salmonella Listeria and E coli also viruses algae parasites and fungi

Chemical There are three principle types of chemical toxins found in foods naturally occurring chemicals eg cyanides in some root crops and allergenic compounds in peanuts toxins produced by micro-organisms eg mycotoxins

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and algal toxins and chemicals added to the commodity by man to control an identified problem eg fungicides or insecticides

Physical contaminants such as broken glass metal fragments insects or stones

The probability that a hazard will occur is called a risk The risk may take a value from zero to one depending on the degree of certainty that the hazard will be absent or that it will be present After hazard identification a hazard analysis must be conducted to understand the relative health risk to man or animal posed by the hazard It is a way of organizing and analyzing the available scientific information on the nature and size of the health risk associated with the hazard The risk may have to be assessed subjectively and simply classified as low medium or high Only those hazards considered by the HACCP team to present an unacceptable risk of being present are taken forward to Stage 7 Principle 2

Once a food safety hazard has been identified then appropriate control measures should be considered These are any action or activity that can be used to control the identified hazard such that it is prevented eliminated or reduced to an acceptable level The control measure may also include training of personnel for a particular operation covered by Good Manufacturing Processes ( GMP)

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

To identify all biological chemical physical and allergen hazards associated with the purchasing delivering storing usage and sale of BLANKrsquos services

Biological Hazards

The following biological hazards were covered by the terms of reference of our HACCP study

1 Yeast amp Moulds2 Coliforms3 E coli4 Listeria5 Salmonella6 Enterobacteriaceae7 Aerobic Mesophile8 Salmonella spp

Chemical Hazards

The following chemical hazards were covered by the terms of reference of our HACCP study

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 20 of 45 Rev 0

1 Cleaning residues2 Printing inks lacquers from packaging3 Chemical contaminants and residues in raw materials

Physical Hazards

The following physical hazards were covered by the terms of reference of our HACCP study

1 Metal2 Glass3 Hair4 Wooden splinters5 Dust dirt particles6 Plastic7 Insects

Allergen Hazards

All the following common allergens were considered as part of our HACCP study

1 Milk2 Egg3 Nuts4 Soya5 Gluten6 Crustaceans7 Fish8 Peanuts9 Celery10 Mustard11 Sesame Seeds12 Sulphites13 Lupin14 Molluscs and products thereof

CHEMICALS USED IN FOOD PROCESSINGPoint of use Type of chemicalGrowing crops Pesticides herbicides defoliants Raising livestock Growth hormones antibiotics Production Food additives processing aids Plant maintenance

Lubricants paints solvents

Plant sanitation Cleaners sanitizing agents pesticides

SOME FOOD-BORNE BIOLOGICAL HAZARDS

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 21 of 45 Rev 0

Bacteria Parasites Seafood toxinsAeromonas hydrophila

Anisakis spp Ciguatera fish poisoning

Bacillus cereus Ascaris lumbricoides Gempylotoxin Brucella spp Cyclospora

cayetanensisTetrodotoxin

Campylobacter jejuni

Cryptosporidium parvum

Scombrotoxin ( histamine )

Clostridium botulinum

Diphyllobothrium spp Paralytic neurotoxic and

Clostridium perfringens

Entamoeba histolytica Diarrhetic shellfish poisoning

Listeria monocytogenes

Giardia lamblia

Pathogenic Escherichia coli

Taenia spp

Plesiomonas shigelloides

Viruses

Salmonella spp Hepatitis A virusShigella spp Mycotoxigenic moulds PoliovirusesStaphylococcus aureus

Aspergillus spp Norwalk virus group

Streptococcus pyogenes

Fusarium spp

Vibrio cholera Penicillium sppV parahaemolyticusV vulnificusYersinia enterocolitica

EXAMPLES OF PHYSICAL HAZARDS amp THEIR SOURCESPhysical hazard

Source

Metal Bolts nuts screws screens sieves steel woolGlass Light bulbs watch crystals thermometers etcWood splinters Pallets equipment bracing overhead structureInsects Environment electrocution traps incoming ingredients Hair Meat ingredients employees clothing rodentsMould Poor sanitation inadequate cleaning of equipmentRodents droppings

Inadequate rodent controls incoming ingredients

Dirt rocks Raw materials poor employee practices Paint flakes Equipment overhead structureBand-aid Poor employee practicesPen caps Poor employee practicesCarcass ID tags Slaughterhouse

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 22 of 45 Rev 0

Hypodermic needles

Veterinarian

Bullets shot BBs

Animals shot while in fields

Feathers Poor sanitation inadequate pest ( bird ) controls Gasket material Inadequate preventive maintenance of equipment Grease Poor equipment maintenance programme

NB Please refer to the generic Hazard Analysis Questionnaire ( under CHECKLISTS ) ndash this checklist is for PER PRODUCT USED

INFO can also be obtained from the productsrsquo MSDS ( MATERIAL SAFETY DATASHEET ) AND OR The Productsrsquo Ingredients Listing

EXAMPLE 1 OF HACCP DECISION TREE

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Q1 Does this step involve a hazard of sufficient likelihood of occurrence and severity to warrant its control

Q3 Is control at this step necessary to prevent eliminate or reduce the risk of hazard to consumers

Modify step process or product

Yes

Is control at this step necessary for safety

Q2 Does a control measure for the hazard exist at this step

Yes

Yes

Yes

No

No

No

No

Not a CCP

This is a critical control point

Not a CCP

Not a CCP

EXAMPLE 2 OF HACCP DECISION TREE

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Q2 Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level

No

Yes

Q1 Do control measure(s) exist for the identified hazard

Modify step process or product

Q4 Will a subsequent step prior to consuming the food eliminate the identified hazard(s) or reduce the likely occurrence to an acceptable level

Q3 Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable level(s)

Yes

Yes

Yes

Yes

No

No

No

Is control at this step necessary for safety

Not a CCP

Not a CCP

This is a critical control point

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

Biological Hazards123456789101112131415

Chemical Hazards123456789101112131415

Physical Hazards12

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 25 of 45 Rev 0

3

456789101112131415

Allergen Hazards123456789101112131415

Stage 7 DETERMINING CRITICAL CONTROL POINT (CCPS) (DECISION TREE)

(Principle 2)

The HACCP team shall determine whether a particular step in the food handling process is a CCP

The method by which a CCP is determined shall be recorder

NOTE The decision tree in annex B can be as a guideline

INTRODUCTION

A Critical Control Point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level

If a hazard has been identified at a step where control is necessary for safety and no control measure exists at that step or any other then the product or process should be modified at that step or at any earlier or later stage to include a control measure

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 26 of 45 Rev 0

Determine the Critical Control Points (CCPs)

Each step in the commodity flow diagram within the scope of the HACCP study should be taken in turn and the relevance of each identified hazard should be considered It is also important to remember the stated scope of the HACCP analysis at this stage The team must determine whether the hazard can occur at this step and if so whether control measures exist If the hazard can be controlled adequately and is not best controlled at another step and is essential for food safety then this step is a CCP for the specified hazard A decision tree can be used to determine CCPs However the HACCP teams judgement expertise and knowledge of the process are the major factors in establishing CCPs

If a step is identified where a food safety hazard exists but no adequate control measures can be put in place either at this step or subsequently then the product is unsafe for human consumption Production should cease until control measures are available and a CCP can be introduced

The proper identification of Critical Control Points (CCPs) is crucial to the ultimate effectiveness of a HACCP plan The plan must specify where each identified hazard will be controlled

Hazards that cannot be controlled by the operator must be identified on the HACCP plan The plan must indicate how these hazards will be addressed outside the establishment (ie purchasing pre-frozen fish where the supplier is responsible for the freezing requirements as specified by regulation)

Note The evaluation for completeness of the written CCPs will ensure that all relevant information dealing with critical limits monitoring corrective actions verification procedures and record keeping is specified for each identified hazard

D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S ( C C P S )( C C P S ) (HACCP principle 2)

The determination of a CCP in the HACCP system shall be facilitated using a decision tree ndash as is shown in the following diagram

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 27 of 45 Rev 0

HACCP concept element Application step amp principle

Define the food and the processes involved in production

Break down the process into steps

Determine possible hazards associated with each step and probability of hazard persistence in end product if no affective preventive measures are implemented

Specify control measures

Consequently determine critical control points ( CCPs )

Establish critical limits

Monitor CCPs to ensure proper implementation of control measures

Take corrective action when parameter monitoring indicates failure of control measure

HACCP principles 4 and 5

Application steps 9-10

HACCP principles 2 and 3

Application steps 7-8

HACCP principle 1

Application step 6

Application steps 1-5

System to be reviewed confirmed and audited

Records must be generated for the system to be documented

HACCP principles 6 and 7

Application steps 11-12

Stage 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP (Principle 3)

The HACCP team shall establish specific and measurable critical limits appropriate for each CCP Critical limits that can be measured quickly and easily shall be used Measurements can include sensory examination mass measurements temperature measurements time moisture level PH value and chemical analysis

Records shall be kept

Establish critical limits for each CCP

Critical limits must be specified and validated for each CCP Criteria often used include measurements of temperature time moisture level pH water activity and sensory parameters such as visual appearance In the case of mycotoxins for example they may include the moisture content or the temperature of the commodity All critical limits and the associated permissible tolerances must be documented in the HACCP Plan Worksheet and included as specifications in operating procedures and work instructions

ie Critical limits have to be established for all critical components associated with each hazard that is controlled by a CCP

Critical Limits must meet or exceed relevant regulatory and program requirements Some establishments set critical limits to exceed regulatory requirements This is acceptable but the establishment should be made aware that if these limits are the ones written into the HACCP plan the inspection will be conducted against these more stringent limits

Critical limits normally include measurements such as temperature time moisture level pH aw available chlorine and sensory attributes When applicable compare the critical limits found the establishment HACCP plan to those considered standard industry practice

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For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 29 of 45 Rev 0

upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

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8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 32 of 45 Rev 0

Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 34 of 45 Rev 0

NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

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81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

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acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 45 of 45 Rev 0

Page 20: BLANK HACCP STUDY

and algal toxins and chemicals added to the commodity by man to control an identified problem eg fungicides or insecticides

Physical contaminants such as broken glass metal fragments insects or stones

The probability that a hazard will occur is called a risk The risk may take a value from zero to one depending on the degree of certainty that the hazard will be absent or that it will be present After hazard identification a hazard analysis must be conducted to understand the relative health risk to man or animal posed by the hazard It is a way of organizing and analyzing the available scientific information on the nature and size of the health risk associated with the hazard The risk may have to be assessed subjectively and simply classified as low medium or high Only those hazards considered by the HACCP team to present an unacceptable risk of being present are taken forward to Stage 7 Principle 2

Once a food safety hazard has been identified then appropriate control measures should be considered These are any action or activity that can be used to control the identified hazard such that it is prevented eliminated or reduced to an acceptable level The control measure may also include training of personnel for a particular operation covered by Good Manufacturing Processes ( GMP)

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

To identify all biological chemical physical and allergen hazards associated with the purchasing delivering storing usage and sale of BLANKrsquos services

Biological Hazards

The following biological hazards were covered by the terms of reference of our HACCP study

1 Yeast amp Moulds2 Coliforms3 E coli4 Listeria5 Salmonella6 Enterobacteriaceae7 Aerobic Mesophile8 Salmonella spp

Chemical Hazards

The following chemical hazards were covered by the terms of reference of our HACCP study

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 20 of 45 Rev 0

1 Cleaning residues2 Printing inks lacquers from packaging3 Chemical contaminants and residues in raw materials

Physical Hazards

The following physical hazards were covered by the terms of reference of our HACCP study

1 Metal2 Glass3 Hair4 Wooden splinters5 Dust dirt particles6 Plastic7 Insects

Allergen Hazards

All the following common allergens were considered as part of our HACCP study

1 Milk2 Egg3 Nuts4 Soya5 Gluten6 Crustaceans7 Fish8 Peanuts9 Celery10 Mustard11 Sesame Seeds12 Sulphites13 Lupin14 Molluscs and products thereof

CHEMICALS USED IN FOOD PROCESSINGPoint of use Type of chemicalGrowing crops Pesticides herbicides defoliants Raising livestock Growth hormones antibiotics Production Food additives processing aids Plant maintenance

Lubricants paints solvents

Plant sanitation Cleaners sanitizing agents pesticides

SOME FOOD-BORNE BIOLOGICAL HAZARDS

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Bacteria Parasites Seafood toxinsAeromonas hydrophila

Anisakis spp Ciguatera fish poisoning

Bacillus cereus Ascaris lumbricoides Gempylotoxin Brucella spp Cyclospora

cayetanensisTetrodotoxin

Campylobacter jejuni

Cryptosporidium parvum

Scombrotoxin ( histamine )

Clostridium botulinum

Diphyllobothrium spp Paralytic neurotoxic and

Clostridium perfringens

Entamoeba histolytica Diarrhetic shellfish poisoning

Listeria monocytogenes

Giardia lamblia

Pathogenic Escherichia coli

Taenia spp

Plesiomonas shigelloides

Viruses

Salmonella spp Hepatitis A virusShigella spp Mycotoxigenic moulds PoliovirusesStaphylococcus aureus

Aspergillus spp Norwalk virus group

Streptococcus pyogenes

Fusarium spp

Vibrio cholera Penicillium sppV parahaemolyticusV vulnificusYersinia enterocolitica

EXAMPLES OF PHYSICAL HAZARDS amp THEIR SOURCESPhysical hazard

Source

Metal Bolts nuts screws screens sieves steel woolGlass Light bulbs watch crystals thermometers etcWood splinters Pallets equipment bracing overhead structureInsects Environment electrocution traps incoming ingredients Hair Meat ingredients employees clothing rodentsMould Poor sanitation inadequate cleaning of equipmentRodents droppings

Inadequate rodent controls incoming ingredients

Dirt rocks Raw materials poor employee practices Paint flakes Equipment overhead structureBand-aid Poor employee practicesPen caps Poor employee practicesCarcass ID tags Slaughterhouse

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Hypodermic needles

Veterinarian

Bullets shot BBs

Animals shot while in fields

Feathers Poor sanitation inadequate pest ( bird ) controls Gasket material Inadequate preventive maintenance of equipment Grease Poor equipment maintenance programme

NB Please refer to the generic Hazard Analysis Questionnaire ( under CHECKLISTS ) ndash this checklist is for PER PRODUCT USED

INFO can also be obtained from the productsrsquo MSDS ( MATERIAL SAFETY DATASHEET ) AND OR The Productsrsquo Ingredients Listing

EXAMPLE 1 OF HACCP DECISION TREE

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Q1 Does this step involve a hazard of sufficient likelihood of occurrence and severity to warrant its control

Q3 Is control at this step necessary to prevent eliminate or reduce the risk of hazard to consumers

Modify step process or product

Yes

Is control at this step necessary for safety

Q2 Does a control measure for the hazard exist at this step

Yes

Yes

Yes

No

No

No

No

Not a CCP

This is a critical control point

Not a CCP

Not a CCP

EXAMPLE 2 OF HACCP DECISION TREE

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Q2 Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level

No

Yes

Q1 Do control measure(s) exist for the identified hazard

Modify step process or product

Q4 Will a subsequent step prior to consuming the food eliminate the identified hazard(s) or reduce the likely occurrence to an acceptable level

Q3 Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable level(s)

Yes

Yes

Yes

Yes

No

No

No

Is control at this step necessary for safety

Not a CCP

Not a CCP

This is a critical control point

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

Biological Hazards123456789101112131415

Chemical Hazards123456789101112131415

Physical Hazards12

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 25 of 45 Rev 0

3

456789101112131415

Allergen Hazards123456789101112131415

Stage 7 DETERMINING CRITICAL CONTROL POINT (CCPS) (DECISION TREE)

(Principle 2)

The HACCP team shall determine whether a particular step in the food handling process is a CCP

The method by which a CCP is determined shall be recorder

NOTE The decision tree in annex B can be as a guideline

INTRODUCTION

A Critical Control Point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level

If a hazard has been identified at a step where control is necessary for safety and no control measure exists at that step or any other then the product or process should be modified at that step or at any earlier or later stage to include a control measure

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 26 of 45 Rev 0

Determine the Critical Control Points (CCPs)

Each step in the commodity flow diagram within the scope of the HACCP study should be taken in turn and the relevance of each identified hazard should be considered It is also important to remember the stated scope of the HACCP analysis at this stage The team must determine whether the hazard can occur at this step and if so whether control measures exist If the hazard can be controlled adequately and is not best controlled at another step and is essential for food safety then this step is a CCP for the specified hazard A decision tree can be used to determine CCPs However the HACCP teams judgement expertise and knowledge of the process are the major factors in establishing CCPs

If a step is identified where a food safety hazard exists but no adequate control measures can be put in place either at this step or subsequently then the product is unsafe for human consumption Production should cease until control measures are available and a CCP can be introduced

The proper identification of Critical Control Points (CCPs) is crucial to the ultimate effectiveness of a HACCP plan The plan must specify where each identified hazard will be controlled

Hazards that cannot be controlled by the operator must be identified on the HACCP plan The plan must indicate how these hazards will be addressed outside the establishment (ie purchasing pre-frozen fish where the supplier is responsible for the freezing requirements as specified by regulation)

Note The evaluation for completeness of the written CCPs will ensure that all relevant information dealing with critical limits monitoring corrective actions verification procedures and record keeping is specified for each identified hazard

D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S ( C C P S )( C C P S ) (HACCP principle 2)

The determination of a CCP in the HACCP system shall be facilitated using a decision tree ndash as is shown in the following diagram

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 27 of 45 Rev 0

HACCP concept element Application step amp principle

Define the food and the processes involved in production

Break down the process into steps

Determine possible hazards associated with each step and probability of hazard persistence in end product if no affective preventive measures are implemented

Specify control measures

Consequently determine critical control points ( CCPs )

Establish critical limits

Monitor CCPs to ensure proper implementation of control measures

Take corrective action when parameter monitoring indicates failure of control measure

HACCP principles 4 and 5

Application steps 9-10

HACCP principles 2 and 3

Application steps 7-8

HACCP principle 1

Application step 6

Application steps 1-5

System to be reviewed confirmed and audited

Records must be generated for the system to be documented

HACCP principles 6 and 7

Application steps 11-12

Stage 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP (Principle 3)

The HACCP team shall establish specific and measurable critical limits appropriate for each CCP Critical limits that can be measured quickly and easily shall be used Measurements can include sensory examination mass measurements temperature measurements time moisture level PH value and chemical analysis

Records shall be kept

Establish critical limits for each CCP

Critical limits must be specified and validated for each CCP Criteria often used include measurements of temperature time moisture level pH water activity and sensory parameters such as visual appearance In the case of mycotoxins for example they may include the moisture content or the temperature of the commodity All critical limits and the associated permissible tolerances must be documented in the HACCP Plan Worksheet and included as specifications in operating procedures and work instructions

ie Critical limits have to be established for all critical components associated with each hazard that is controlled by a CCP

Critical Limits must meet or exceed relevant regulatory and program requirements Some establishments set critical limits to exceed regulatory requirements This is acceptable but the establishment should be made aware that if these limits are the ones written into the HACCP plan the inspection will be conducted against these more stringent limits

Critical limits normally include measurements such as temperature time moisture level pH aw available chlorine and sensory attributes When applicable compare the critical limits found the establishment HACCP plan to those considered standard industry practice

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For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 29 of 45 Rev 0

upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

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8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

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81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

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acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

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Page 21: BLANK HACCP STUDY

1 Cleaning residues2 Printing inks lacquers from packaging3 Chemical contaminants and residues in raw materials

Physical Hazards

The following physical hazards were covered by the terms of reference of our HACCP study

1 Metal2 Glass3 Hair4 Wooden splinters5 Dust dirt particles6 Plastic7 Insects

Allergen Hazards

All the following common allergens were considered as part of our HACCP study

1 Milk2 Egg3 Nuts4 Soya5 Gluten6 Crustaceans7 Fish8 Peanuts9 Celery10 Mustard11 Sesame Seeds12 Sulphites13 Lupin14 Molluscs and products thereof

CHEMICALS USED IN FOOD PROCESSINGPoint of use Type of chemicalGrowing crops Pesticides herbicides defoliants Raising livestock Growth hormones antibiotics Production Food additives processing aids Plant maintenance

Lubricants paints solvents

Plant sanitation Cleaners sanitizing agents pesticides

SOME FOOD-BORNE BIOLOGICAL HAZARDS

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Bacteria Parasites Seafood toxinsAeromonas hydrophila

Anisakis spp Ciguatera fish poisoning

Bacillus cereus Ascaris lumbricoides Gempylotoxin Brucella spp Cyclospora

cayetanensisTetrodotoxin

Campylobacter jejuni

Cryptosporidium parvum

Scombrotoxin ( histamine )

Clostridium botulinum

Diphyllobothrium spp Paralytic neurotoxic and

Clostridium perfringens

Entamoeba histolytica Diarrhetic shellfish poisoning

Listeria monocytogenes

Giardia lamblia

Pathogenic Escherichia coli

Taenia spp

Plesiomonas shigelloides

Viruses

Salmonella spp Hepatitis A virusShigella spp Mycotoxigenic moulds PoliovirusesStaphylococcus aureus

Aspergillus spp Norwalk virus group

Streptococcus pyogenes

Fusarium spp

Vibrio cholera Penicillium sppV parahaemolyticusV vulnificusYersinia enterocolitica

EXAMPLES OF PHYSICAL HAZARDS amp THEIR SOURCESPhysical hazard

Source

Metal Bolts nuts screws screens sieves steel woolGlass Light bulbs watch crystals thermometers etcWood splinters Pallets equipment bracing overhead structureInsects Environment electrocution traps incoming ingredients Hair Meat ingredients employees clothing rodentsMould Poor sanitation inadequate cleaning of equipmentRodents droppings

Inadequate rodent controls incoming ingredients

Dirt rocks Raw materials poor employee practices Paint flakes Equipment overhead structureBand-aid Poor employee practicesPen caps Poor employee practicesCarcass ID tags Slaughterhouse

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Hypodermic needles

Veterinarian

Bullets shot BBs

Animals shot while in fields

Feathers Poor sanitation inadequate pest ( bird ) controls Gasket material Inadequate preventive maintenance of equipment Grease Poor equipment maintenance programme

NB Please refer to the generic Hazard Analysis Questionnaire ( under CHECKLISTS ) ndash this checklist is for PER PRODUCT USED

INFO can also be obtained from the productsrsquo MSDS ( MATERIAL SAFETY DATASHEET ) AND OR The Productsrsquo Ingredients Listing

EXAMPLE 1 OF HACCP DECISION TREE

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Q1 Does this step involve a hazard of sufficient likelihood of occurrence and severity to warrant its control

Q3 Is control at this step necessary to prevent eliminate or reduce the risk of hazard to consumers

Modify step process or product

Yes

Is control at this step necessary for safety

Q2 Does a control measure for the hazard exist at this step

Yes

Yes

Yes

No

No

No

No

Not a CCP

This is a critical control point

Not a CCP

Not a CCP

EXAMPLE 2 OF HACCP DECISION TREE

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Q2 Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level

No

Yes

Q1 Do control measure(s) exist for the identified hazard

Modify step process or product

Q4 Will a subsequent step prior to consuming the food eliminate the identified hazard(s) or reduce the likely occurrence to an acceptable level

Q3 Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable level(s)

Yes

Yes

Yes

Yes

No

No

No

Is control at this step necessary for safety

Not a CCP

Not a CCP

This is a critical control point

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

Biological Hazards123456789101112131415

Chemical Hazards123456789101112131415

Physical Hazards12

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3

456789101112131415

Allergen Hazards123456789101112131415

Stage 7 DETERMINING CRITICAL CONTROL POINT (CCPS) (DECISION TREE)

(Principle 2)

The HACCP team shall determine whether a particular step in the food handling process is a CCP

The method by which a CCP is determined shall be recorder

NOTE The decision tree in annex B can be as a guideline

INTRODUCTION

A Critical Control Point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level

If a hazard has been identified at a step where control is necessary for safety and no control measure exists at that step or any other then the product or process should be modified at that step or at any earlier or later stage to include a control measure

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Determine the Critical Control Points (CCPs)

Each step in the commodity flow diagram within the scope of the HACCP study should be taken in turn and the relevance of each identified hazard should be considered It is also important to remember the stated scope of the HACCP analysis at this stage The team must determine whether the hazard can occur at this step and if so whether control measures exist If the hazard can be controlled adequately and is not best controlled at another step and is essential for food safety then this step is a CCP for the specified hazard A decision tree can be used to determine CCPs However the HACCP teams judgement expertise and knowledge of the process are the major factors in establishing CCPs

If a step is identified where a food safety hazard exists but no adequate control measures can be put in place either at this step or subsequently then the product is unsafe for human consumption Production should cease until control measures are available and a CCP can be introduced

The proper identification of Critical Control Points (CCPs) is crucial to the ultimate effectiveness of a HACCP plan The plan must specify where each identified hazard will be controlled

Hazards that cannot be controlled by the operator must be identified on the HACCP plan The plan must indicate how these hazards will be addressed outside the establishment (ie purchasing pre-frozen fish where the supplier is responsible for the freezing requirements as specified by regulation)

Note The evaluation for completeness of the written CCPs will ensure that all relevant information dealing with critical limits monitoring corrective actions verification procedures and record keeping is specified for each identified hazard

D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S ( C C P S )( C C P S ) (HACCP principle 2)

The determination of a CCP in the HACCP system shall be facilitated using a decision tree ndash as is shown in the following diagram

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HACCP concept element Application step amp principle

Define the food and the processes involved in production

Break down the process into steps

Determine possible hazards associated with each step and probability of hazard persistence in end product if no affective preventive measures are implemented

Specify control measures

Consequently determine critical control points ( CCPs )

Establish critical limits

Monitor CCPs to ensure proper implementation of control measures

Take corrective action when parameter monitoring indicates failure of control measure

HACCP principles 4 and 5

Application steps 9-10

HACCP principles 2 and 3

Application steps 7-8

HACCP principle 1

Application step 6

Application steps 1-5

System to be reviewed confirmed and audited

Records must be generated for the system to be documented

HACCP principles 6 and 7

Application steps 11-12

Stage 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP (Principle 3)

The HACCP team shall establish specific and measurable critical limits appropriate for each CCP Critical limits that can be measured quickly and easily shall be used Measurements can include sensory examination mass measurements temperature measurements time moisture level PH value and chemical analysis

Records shall be kept

Establish critical limits for each CCP

Critical limits must be specified and validated for each CCP Criteria often used include measurements of temperature time moisture level pH water activity and sensory parameters such as visual appearance In the case of mycotoxins for example they may include the moisture content or the temperature of the commodity All critical limits and the associated permissible tolerances must be documented in the HACCP Plan Worksheet and included as specifications in operating procedures and work instructions

ie Critical limits have to be established for all critical components associated with each hazard that is controlled by a CCP

Critical Limits must meet or exceed relevant regulatory and program requirements Some establishments set critical limits to exceed regulatory requirements This is acceptable but the establishment should be made aware that if these limits are the ones written into the HACCP plan the inspection will be conducted against these more stringent limits

Critical limits normally include measurements such as temperature time moisture level pH aw available chlorine and sensory attributes When applicable compare the critical limits found the establishment HACCP plan to those considered standard industry practice

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For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

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upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

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8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

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81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

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acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

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Page 22: BLANK HACCP STUDY

Bacteria Parasites Seafood toxinsAeromonas hydrophila

Anisakis spp Ciguatera fish poisoning

Bacillus cereus Ascaris lumbricoides Gempylotoxin Brucella spp Cyclospora

cayetanensisTetrodotoxin

Campylobacter jejuni

Cryptosporidium parvum

Scombrotoxin ( histamine )

Clostridium botulinum

Diphyllobothrium spp Paralytic neurotoxic and

Clostridium perfringens

Entamoeba histolytica Diarrhetic shellfish poisoning

Listeria monocytogenes

Giardia lamblia

Pathogenic Escherichia coli

Taenia spp

Plesiomonas shigelloides

Viruses

Salmonella spp Hepatitis A virusShigella spp Mycotoxigenic moulds PoliovirusesStaphylococcus aureus

Aspergillus spp Norwalk virus group

Streptococcus pyogenes

Fusarium spp

Vibrio cholera Penicillium sppV parahaemolyticusV vulnificusYersinia enterocolitica

EXAMPLES OF PHYSICAL HAZARDS amp THEIR SOURCESPhysical hazard

Source

Metal Bolts nuts screws screens sieves steel woolGlass Light bulbs watch crystals thermometers etcWood splinters Pallets equipment bracing overhead structureInsects Environment electrocution traps incoming ingredients Hair Meat ingredients employees clothing rodentsMould Poor sanitation inadequate cleaning of equipmentRodents droppings

Inadequate rodent controls incoming ingredients

Dirt rocks Raw materials poor employee practices Paint flakes Equipment overhead structureBand-aid Poor employee practicesPen caps Poor employee practicesCarcass ID tags Slaughterhouse

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Hypodermic needles

Veterinarian

Bullets shot BBs

Animals shot while in fields

Feathers Poor sanitation inadequate pest ( bird ) controls Gasket material Inadequate preventive maintenance of equipment Grease Poor equipment maintenance programme

NB Please refer to the generic Hazard Analysis Questionnaire ( under CHECKLISTS ) ndash this checklist is for PER PRODUCT USED

INFO can also be obtained from the productsrsquo MSDS ( MATERIAL SAFETY DATASHEET ) AND OR The Productsrsquo Ingredients Listing

EXAMPLE 1 OF HACCP DECISION TREE

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Q1 Does this step involve a hazard of sufficient likelihood of occurrence and severity to warrant its control

Q3 Is control at this step necessary to prevent eliminate or reduce the risk of hazard to consumers

Modify step process or product

Yes

Is control at this step necessary for safety

Q2 Does a control measure for the hazard exist at this step

Yes

Yes

Yes

No

No

No

No

Not a CCP

This is a critical control point

Not a CCP

Not a CCP

EXAMPLE 2 OF HACCP DECISION TREE

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Q2 Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level

No

Yes

Q1 Do control measure(s) exist for the identified hazard

Modify step process or product

Q4 Will a subsequent step prior to consuming the food eliminate the identified hazard(s) or reduce the likely occurrence to an acceptable level

Q3 Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable level(s)

Yes

Yes

Yes

Yes

No

No

No

Is control at this step necessary for safety

Not a CCP

Not a CCP

This is a critical control point

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

Biological Hazards123456789101112131415

Chemical Hazards123456789101112131415

Physical Hazards12

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 25 of 45 Rev 0

3

456789101112131415

Allergen Hazards123456789101112131415

Stage 7 DETERMINING CRITICAL CONTROL POINT (CCPS) (DECISION TREE)

(Principle 2)

The HACCP team shall determine whether a particular step in the food handling process is a CCP

The method by which a CCP is determined shall be recorder

NOTE The decision tree in annex B can be as a guideline

INTRODUCTION

A Critical Control Point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level

If a hazard has been identified at a step where control is necessary for safety and no control measure exists at that step or any other then the product or process should be modified at that step or at any earlier or later stage to include a control measure

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 26 of 45 Rev 0

Determine the Critical Control Points (CCPs)

Each step in the commodity flow diagram within the scope of the HACCP study should be taken in turn and the relevance of each identified hazard should be considered It is also important to remember the stated scope of the HACCP analysis at this stage The team must determine whether the hazard can occur at this step and if so whether control measures exist If the hazard can be controlled adequately and is not best controlled at another step and is essential for food safety then this step is a CCP for the specified hazard A decision tree can be used to determine CCPs However the HACCP teams judgement expertise and knowledge of the process are the major factors in establishing CCPs

If a step is identified where a food safety hazard exists but no adequate control measures can be put in place either at this step or subsequently then the product is unsafe for human consumption Production should cease until control measures are available and a CCP can be introduced

The proper identification of Critical Control Points (CCPs) is crucial to the ultimate effectiveness of a HACCP plan The plan must specify where each identified hazard will be controlled

Hazards that cannot be controlled by the operator must be identified on the HACCP plan The plan must indicate how these hazards will be addressed outside the establishment (ie purchasing pre-frozen fish where the supplier is responsible for the freezing requirements as specified by regulation)

Note The evaluation for completeness of the written CCPs will ensure that all relevant information dealing with critical limits monitoring corrective actions verification procedures and record keeping is specified for each identified hazard

D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S ( C C P S )( C C P S ) (HACCP principle 2)

The determination of a CCP in the HACCP system shall be facilitated using a decision tree ndash as is shown in the following diagram

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HACCP concept element Application step amp principle

Define the food and the processes involved in production

Break down the process into steps

Determine possible hazards associated with each step and probability of hazard persistence in end product if no affective preventive measures are implemented

Specify control measures

Consequently determine critical control points ( CCPs )

Establish critical limits

Monitor CCPs to ensure proper implementation of control measures

Take corrective action when parameter monitoring indicates failure of control measure

HACCP principles 4 and 5

Application steps 9-10

HACCP principles 2 and 3

Application steps 7-8

HACCP principle 1

Application step 6

Application steps 1-5

System to be reviewed confirmed and audited

Records must be generated for the system to be documented

HACCP principles 6 and 7

Application steps 11-12

Stage 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP (Principle 3)

The HACCP team shall establish specific and measurable critical limits appropriate for each CCP Critical limits that can be measured quickly and easily shall be used Measurements can include sensory examination mass measurements temperature measurements time moisture level PH value and chemical analysis

Records shall be kept

Establish critical limits for each CCP

Critical limits must be specified and validated for each CCP Criteria often used include measurements of temperature time moisture level pH water activity and sensory parameters such as visual appearance In the case of mycotoxins for example they may include the moisture content or the temperature of the commodity All critical limits and the associated permissible tolerances must be documented in the HACCP Plan Worksheet and included as specifications in operating procedures and work instructions

ie Critical limits have to be established for all critical components associated with each hazard that is controlled by a CCP

Critical Limits must meet or exceed relevant regulatory and program requirements Some establishments set critical limits to exceed regulatory requirements This is acceptable but the establishment should be made aware that if these limits are the ones written into the HACCP plan the inspection will be conducted against these more stringent limits

Critical limits normally include measurements such as temperature time moisture level pH aw available chlorine and sensory attributes When applicable compare the critical limits found the establishment HACCP plan to those considered standard industry practice

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For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

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upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

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8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

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81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

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acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

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Page 23: BLANK HACCP STUDY

Hypodermic needles

Veterinarian

Bullets shot BBs

Animals shot while in fields

Feathers Poor sanitation inadequate pest ( bird ) controls Gasket material Inadequate preventive maintenance of equipment Grease Poor equipment maintenance programme

NB Please refer to the generic Hazard Analysis Questionnaire ( under CHECKLISTS ) ndash this checklist is for PER PRODUCT USED

INFO can also be obtained from the productsrsquo MSDS ( MATERIAL SAFETY DATASHEET ) AND OR The Productsrsquo Ingredients Listing

EXAMPLE 1 OF HACCP DECISION TREE

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Q1 Does this step involve a hazard of sufficient likelihood of occurrence and severity to warrant its control

Q3 Is control at this step necessary to prevent eliminate or reduce the risk of hazard to consumers

Modify step process or product

Yes

Is control at this step necessary for safety

Q2 Does a control measure for the hazard exist at this step

Yes

Yes

Yes

No

No

No

No

Not a CCP

This is a critical control point

Not a CCP

Not a CCP

EXAMPLE 2 OF HACCP DECISION TREE

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Q2 Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level

No

Yes

Q1 Do control measure(s) exist for the identified hazard

Modify step process or product

Q4 Will a subsequent step prior to consuming the food eliminate the identified hazard(s) or reduce the likely occurrence to an acceptable level

Q3 Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable level(s)

Yes

Yes

Yes

Yes

No

No

No

Is control at this step necessary for safety

Not a CCP

Not a CCP

This is a critical control point

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

Biological Hazards123456789101112131415

Chemical Hazards123456789101112131415

Physical Hazards12

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 25 of 45 Rev 0

3

456789101112131415

Allergen Hazards123456789101112131415

Stage 7 DETERMINING CRITICAL CONTROL POINT (CCPS) (DECISION TREE)

(Principle 2)

The HACCP team shall determine whether a particular step in the food handling process is a CCP

The method by which a CCP is determined shall be recorder

NOTE The decision tree in annex B can be as a guideline

INTRODUCTION

A Critical Control Point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level

If a hazard has been identified at a step where control is necessary for safety and no control measure exists at that step or any other then the product or process should be modified at that step or at any earlier or later stage to include a control measure

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Determine the Critical Control Points (CCPs)

Each step in the commodity flow diagram within the scope of the HACCP study should be taken in turn and the relevance of each identified hazard should be considered It is also important to remember the stated scope of the HACCP analysis at this stage The team must determine whether the hazard can occur at this step and if so whether control measures exist If the hazard can be controlled adequately and is not best controlled at another step and is essential for food safety then this step is a CCP for the specified hazard A decision tree can be used to determine CCPs However the HACCP teams judgement expertise and knowledge of the process are the major factors in establishing CCPs

If a step is identified where a food safety hazard exists but no adequate control measures can be put in place either at this step or subsequently then the product is unsafe for human consumption Production should cease until control measures are available and a CCP can be introduced

The proper identification of Critical Control Points (CCPs) is crucial to the ultimate effectiveness of a HACCP plan The plan must specify where each identified hazard will be controlled

Hazards that cannot be controlled by the operator must be identified on the HACCP plan The plan must indicate how these hazards will be addressed outside the establishment (ie purchasing pre-frozen fish where the supplier is responsible for the freezing requirements as specified by regulation)

Note The evaluation for completeness of the written CCPs will ensure that all relevant information dealing with critical limits monitoring corrective actions verification procedures and record keeping is specified for each identified hazard

D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S ( C C P S )( C C P S ) (HACCP principle 2)

The determination of a CCP in the HACCP system shall be facilitated using a decision tree ndash as is shown in the following diagram

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HACCP concept element Application step amp principle

Define the food and the processes involved in production

Break down the process into steps

Determine possible hazards associated with each step and probability of hazard persistence in end product if no affective preventive measures are implemented

Specify control measures

Consequently determine critical control points ( CCPs )

Establish critical limits

Monitor CCPs to ensure proper implementation of control measures

Take corrective action when parameter monitoring indicates failure of control measure

HACCP principles 4 and 5

Application steps 9-10

HACCP principles 2 and 3

Application steps 7-8

HACCP principle 1

Application step 6

Application steps 1-5

System to be reviewed confirmed and audited

Records must be generated for the system to be documented

HACCP principles 6 and 7

Application steps 11-12

Stage 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP (Principle 3)

The HACCP team shall establish specific and measurable critical limits appropriate for each CCP Critical limits that can be measured quickly and easily shall be used Measurements can include sensory examination mass measurements temperature measurements time moisture level PH value and chemical analysis

Records shall be kept

Establish critical limits for each CCP

Critical limits must be specified and validated for each CCP Criteria often used include measurements of temperature time moisture level pH water activity and sensory parameters such as visual appearance In the case of mycotoxins for example they may include the moisture content or the temperature of the commodity All critical limits and the associated permissible tolerances must be documented in the HACCP Plan Worksheet and included as specifications in operating procedures and work instructions

ie Critical limits have to be established for all critical components associated with each hazard that is controlled by a CCP

Critical Limits must meet or exceed relevant regulatory and program requirements Some establishments set critical limits to exceed regulatory requirements This is acceptable but the establishment should be made aware that if these limits are the ones written into the HACCP plan the inspection will be conducted against these more stringent limits

Critical limits normally include measurements such as temperature time moisture level pH aw available chlorine and sensory attributes When applicable compare the critical limits found the establishment HACCP plan to those considered standard industry practice

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For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

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upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

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8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

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81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

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acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

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Page 24: BLANK HACCP STUDY

EXAMPLE 2 OF HACCP DECISION TREE

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Q2 Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level

No

Yes

Q1 Do control measure(s) exist for the identified hazard

Modify step process or product

Q4 Will a subsequent step prior to consuming the food eliminate the identified hazard(s) or reduce the likely occurrence to an acceptable level

Q3 Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable level(s)

Yes

Yes

Yes

Yes

No

No

No

Is control at this step necessary for safety

Not a CCP

Not a CCP

This is a critical control point

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

Biological Hazards123456789101112131415

Chemical Hazards123456789101112131415

Physical Hazards12

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 25 of 45 Rev 0

3

456789101112131415

Allergen Hazards123456789101112131415

Stage 7 DETERMINING CRITICAL CONTROL POINT (CCPS) (DECISION TREE)

(Principle 2)

The HACCP team shall determine whether a particular step in the food handling process is a CCP

The method by which a CCP is determined shall be recorder

NOTE The decision tree in annex B can be as a guideline

INTRODUCTION

A Critical Control Point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level

If a hazard has been identified at a step where control is necessary for safety and no control measure exists at that step or any other then the product or process should be modified at that step or at any earlier or later stage to include a control measure

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Determine the Critical Control Points (CCPs)

Each step in the commodity flow diagram within the scope of the HACCP study should be taken in turn and the relevance of each identified hazard should be considered It is also important to remember the stated scope of the HACCP analysis at this stage The team must determine whether the hazard can occur at this step and if so whether control measures exist If the hazard can be controlled adequately and is not best controlled at another step and is essential for food safety then this step is a CCP for the specified hazard A decision tree can be used to determine CCPs However the HACCP teams judgement expertise and knowledge of the process are the major factors in establishing CCPs

If a step is identified where a food safety hazard exists but no adequate control measures can be put in place either at this step or subsequently then the product is unsafe for human consumption Production should cease until control measures are available and a CCP can be introduced

The proper identification of Critical Control Points (CCPs) is crucial to the ultimate effectiveness of a HACCP plan The plan must specify where each identified hazard will be controlled

Hazards that cannot be controlled by the operator must be identified on the HACCP plan The plan must indicate how these hazards will be addressed outside the establishment (ie purchasing pre-frozen fish where the supplier is responsible for the freezing requirements as specified by regulation)

Note The evaluation for completeness of the written CCPs will ensure that all relevant information dealing with critical limits monitoring corrective actions verification procedures and record keeping is specified for each identified hazard

D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S ( C C P S )( C C P S ) (HACCP principle 2)

The determination of a CCP in the HACCP system shall be facilitated using a decision tree ndash as is shown in the following diagram

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HACCP concept element Application step amp principle

Define the food and the processes involved in production

Break down the process into steps

Determine possible hazards associated with each step and probability of hazard persistence in end product if no affective preventive measures are implemented

Specify control measures

Consequently determine critical control points ( CCPs )

Establish critical limits

Monitor CCPs to ensure proper implementation of control measures

Take corrective action when parameter monitoring indicates failure of control measure

HACCP principles 4 and 5

Application steps 9-10

HACCP principles 2 and 3

Application steps 7-8

HACCP principle 1

Application step 6

Application steps 1-5

System to be reviewed confirmed and audited

Records must be generated for the system to be documented

HACCP principles 6 and 7

Application steps 11-12

Stage 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP (Principle 3)

The HACCP team shall establish specific and measurable critical limits appropriate for each CCP Critical limits that can be measured quickly and easily shall be used Measurements can include sensory examination mass measurements temperature measurements time moisture level PH value and chemical analysis

Records shall be kept

Establish critical limits for each CCP

Critical limits must be specified and validated for each CCP Criteria often used include measurements of temperature time moisture level pH water activity and sensory parameters such as visual appearance In the case of mycotoxins for example they may include the moisture content or the temperature of the commodity All critical limits and the associated permissible tolerances must be documented in the HACCP Plan Worksheet and included as specifications in operating procedures and work instructions

ie Critical limits have to be established for all critical components associated with each hazard that is controlled by a CCP

Critical Limits must meet or exceed relevant regulatory and program requirements Some establishments set critical limits to exceed regulatory requirements This is acceptable but the establishment should be made aware that if these limits are the ones written into the HACCP plan the inspection will be conducted against these more stringent limits

Critical limits normally include measurements such as temperature time moisture level pH aw available chlorine and sensory attributes When applicable compare the critical limits found the establishment HACCP plan to those considered standard industry practice

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For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

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upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

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8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

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81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

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acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

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Page 25: BLANK HACCP STUDY

I D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D SI D E N T I F I C A T I O N O F B L A N K rsquo s H A Z A R D S

Biological Hazards123456789101112131415

Chemical Hazards123456789101112131415

Physical Hazards12

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3

456789101112131415

Allergen Hazards123456789101112131415

Stage 7 DETERMINING CRITICAL CONTROL POINT (CCPS) (DECISION TREE)

(Principle 2)

The HACCP team shall determine whether a particular step in the food handling process is a CCP

The method by which a CCP is determined shall be recorder

NOTE The decision tree in annex B can be as a guideline

INTRODUCTION

A Critical Control Point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level

If a hazard has been identified at a step where control is necessary for safety and no control measure exists at that step or any other then the product or process should be modified at that step or at any earlier or later stage to include a control measure

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Determine the Critical Control Points (CCPs)

Each step in the commodity flow diagram within the scope of the HACCP study should be taken in turn and the relevance of each identified hazard should be considered It is also important to remember the stated scope of the HACCP analysis at this stage The team must determine whether the hazard can occur at this step and if so whether control measures exist If the hazard can be controlled adequately and is not best controlled at another step and is essential for food safety then this step is a CCP for the specified hazard A decision tree can be used to determine CCPs However the HACCP teams judgement expertise and knowledge of the process are the major factors in establishing CCPs

If a step is identified where a food safety hazard exists but no adequate control measures can be put in place either at this step or subsequently then the product is unsafe for human consumption Production should cease until control measures are available and a CCP can be introduced

The proper identification of Critical Control Points (CCPs) is crucial to the ultimate effectiveness of a HACCP plan The plan must specify where each identified hazard will be controlled

Hazards that cannot be controlled by the operator must be identified on the HACCP plan The plan must indicate how these hazards will be addressed outside the establishment (ie purchasing pre-frozen fish where the supplier is responsible for the freezing requirements as specified by regulation)

Note The evaluation for completeness of the written CCPs will ensure that all relevant information dealing with critical limits monitoring corrective actions verification procedures and record keeping is specified for each identified hazard

D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S ( C C P S )( C C P S ) (HACCP principle 2)

The determination of a CCP in the HACCP system shall be facilitated using a decision tree ndash as is shown in the following diagram

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HACCP concept element Application step amp principle

Define the food and the processes involved in production

Break down the process into steps

Determine possible hazards associated with each step and probability of hazard persistence in end product if no affective preventive measures are implemented

Specify control measures

Consequently determine critical control points ( CCPs )

Establish critical limits

Monitor CCPs to ensure proper implementation of control measures

Take corrective action when parameter monitoring indicates failure of control measure

HACCP principles 4 and 5

Application steps 9-10

HACCP principles 2 and 3

Application steps 7-8

HACCP principle 1

Application step 6

Application steps 1-5

System to be reviewed confirmed and audited

Records must be generated for the system to be documented

HACCP principles 6 and 7

Application steps 11-12

Stage 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP (Principle 3)

The HACCP team shall establish specific and measurable critical limits appropriate for each CCP Critical limits that can be measured quickly and easily shall be used Measurements can include sensory examination mass measurements temperature measurements time moisture level PH value and chemical analysis

Records shall be kept

Establish critical limits for each CCP

Critical limits must be specified and validated for each CCP Criteria often used include measurements of temperature time moisture level pH water activity and sensory parameters such as visual appearance In the case of mycotoxins for example they may include the moisture content or the temperature of the commodity All critical limits and the associated permissible tolerances must be documented in the HACCP Plan Worksheet and included as specifications in operating procedures and work instructions

ie Critical limits have to be established for all critical components associated with each hazard that is controlled by a CCP

Critical Limits must meet or exceed relevant regulatory and program requirements Some establishments set critical limits to exceed regulatory requirements This is acceptable but the establishment should be made aware that if these limits are the ones written into the HACCP plan the inspection will be conducted against these more stringent limits

Critical limits normally include measurements such as temperature time moisture level pH aw available chlorine and sensory attributes When applicable compare the critical limits found the establishment HACCP plan to those considered standard industry practice

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For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

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upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

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8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

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81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

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acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

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Page 26: BLANK HACCP STUDY

3

456789101112131415

Allergen Hazards123456789101112131415

Stage 7 DETERMINING CRITICAL CONTROL POINT (CCPS) (DECISION TREE)

(Principle 2)

The HACCP team shall determine whether a particular step in the food handling process is a CCP

The method by which a CCP is determined shall be recorder

NOTE The decision tree in annex B can be as a guideline

INTRODUCTION

A Critical Control Point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level

If a hazard has been identified at a step where control is necessary for safety and no control measure exists at that step or any other then the product or process should be modified at that step or at any earlier or later stage to include a control measure

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Determine the Critical Control Points (CCPs)

Each step in the commodity flow diagram within the scope of the HACCP study should be taken in turn and the relevance of each identified hazard should be considered It is also important to remember the stated scope of the HACCP analysis at this stage The team must determine whether the hazard can occur at this step and if so whether control measures exist If the hazard can be controlled adequately and is not best controlled at another step and is essential for food safety then this step is a CCP for the specified hazard A decision tree can be used to determine CCPs However the HACCP teams judgement expertise and knowledge of the process are the major factors in establishing CCPs

If a step is identified where a food safety hazard exists but no adequate control measures can be put in place either at this step or subsequently then the product is unsafe for human consumption Production should cease until control measures are available and a CCP can be introduced

The proper identification of Critical Control Points (CCPs) is crucial to the ultimate effectiveness of a HACCP plan The plan must specify where each identified hazard will be controlled

Hazards that cannot be controlled by the operator must be identified on the HACCP plan The plan must indicate how these hazards will be addressed outside the establishment (ie purchasing pre-frozen fish where the supplier is responsible for the freezing requirements as specified by regulation)

Note The evaluation for completeness of the written CCPs will ensure that all relevant information dealing with critical limits monitoring corrective actions verification procedures and record keeping is specified for each identified hazard

D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S ( C C P S )( C C P S ) (HACCP principle 2)

The determination of a CCP in the HACCP system shall be facilitated using a decision tree ndash as is shown in the following diagram

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HACCP concept element Application step amp principle

Define the food and the processes involved in production

Break down the process into steps

Determine possible hazards associated with each step and probability of hazard persistence in end product if no affective preventive measures are implemented

Specify control measures

Consequently determine critical control points ( CCPs )

Establish critical limits

Monitor CCPs to ensure proper implementation of control measures

Take corrective action when parameter monitoring indicates failure of control measure

HACCP principles 4 and 5

Application steps 9-10

HACCP principles 2 and 3

Application steps 7-8

HACCP principle 1

Application step 6

Application steps 1-5

System to be reviewed confirmed and audited

Records must be generated for the system to be documented

HACCP principles 6 and 7

Application steps 11-12

Stage 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP (Principle 3)

The HACCP team shall establish specific and measurable critical limits appropriate for each CCP Critical limits that can be measured quickly and easily shall be used Measurements can include sensory examination mass measurements temperature measurements time moisture level PH value and chemical analysis

Records shall be kept

Establish critical limits for each CCP

Critical limits must be specified and validated for each CCP Criteria often used include measurements of temperature time moisture level pH water activity and sensory parameters such as visual appearance In the case of mycotoxins for example they may include the moisture content or the temperature of the commodity All critical limits and the associated permissible tolerances must be documented in the HACCP Plan Worksheet and included as specifications in operating procedures and work instructions

ie Critical limits have to be established for all critical components associated with each hazard that is controlled by a CCP

Critical Limits must meet or exceed relevant regulatory and program requirements Some establishments set critical limits to exceed regulatory requirements This is acceptable but the establishment should be made aware that if these limits are the ones written into the HACCP plan the inspection will be conducted against these more stringent limits

Critical limits normally include measurements such as temperature time moisture level pH aw available chlorine and sensory attributes When applicable compare the critical limits found the establishment HACCP plan to those considered standard industry practice

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For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

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upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

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8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

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81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

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acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

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Page 27: BLANK HACCP STUDY

Determine the Critical Control Points (CCPs)

Each step in the commodity flow diagram within the scope of the HACCP study should be taken in turn and the relevance of each identified hazard should be considered It is also important to remember the stated scope of the HACCP analysis at this stage The team must determine whether the hazard can occur at this step and if so whether control measures exist If the hazard can be controlled adequately and is not best controlled at another step and is essential for food safety then this step is a CCP for the specified hazard A decision tree can be used to determine CCPs However the HACCP teams judgement expertise and knowledge of the process are the major factors in establishing CCPs

If a step is identified where a food safety hazard exists but no adequate control measures can be put in place either at this step or subsequently then the product is unsafe for human consumption Production should cease until control measures are available and a CCP can be introduced

The proper identification of Critical Control Points (CCPs) is crucial to the ultimate effectiveness of a HACCP plan The plan must specify where each identified hazard will be controlled

Hazards that cannot be controlled by the operator must be identified on the HACCP plan The plan must indicate how these hazards will be addressed outside the establishment (ie purchasing pre-frozen fish where the supplier is responsible for the freezing requirements as specified by regulation)

Note The evaluation for completeness of the written CCPs will ensure that all relevant information dealing with critical limits monitoring corrective actions verification procedures and record keeping is specified for each identified hazard

D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S D E T E R M I N I N G C R I T I C A L C O N T R O L P O I N T S ( C C P S )( C C P S ) (HACCP principle 2)

The determination of a CCP in the HACCP system shall be facilitated using a decision tree ndash as is shown in the following diagram

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HACCP concept element Application step amp principle

Define the food and the processes involved in production

Break down the process into steps

Determine possible hazards associated with each step and probability of hazard persistence in end product if no affective preventive measures are implemented

Specify control measures

Consequently determine critical control points ( CCPs )

Establish critical limits

Monitor CCPs to ensure proper implementation of control measures

Take corrective action when parameter monitoring indicates failure of control measure

HACCP principles 4 and 5

Application steps 9-10

HACCP principles 2 and 3

Application steps 7-8

HACCP principle 1

Application step 6

Application steps 1-5

System to be reviewed confirmed and audited

Records must be generated for the system to be documented

HACCP principles 6 and 7

Application steps 11-12

Stage 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP (Principle 3)

The HACCP team shall establish specific and measurable critical limits appropriate for each CCP Critical limits that can be measured quickly and easily shall be used Measurements can include sensory examination mass measurements temperature measurements time moisture level PH value and chemical analysis

Records shall be kept

Establish critical limits for each CCP

Critical limits must be specified and validated for each CCP Criteria often used include measurements of temperature time moisture level pH water activity and sensory parameters such as visual appearance In the case of mycotoxins for example they may include the moisture content or the temperature of the commodity All critical limits and the associated permissible tolerances must be documented in the HACCP Plan Worksheet and included as specifications in operating procedures and work instructions

ie Critical limits have to be established for all critical components associated with each hazard that is controlled by a CCP

Critical Limits must meet or exceed relevant regulatory and program requirements Some establishments set critical limits to exceed regulatory requirements This is acceptable but the establishment should be made aware that if these limits are the ones written into the HACCP plan the inspection will be conducted against these more stringent limits

Critical limits normally include measurements such as temperature time moisture level pH aw available chlorine and sensory attributes When applicable compare the critical limits found the establishment HACCP plan to those considered standard industry practice

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For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

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upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

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8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

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81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

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acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

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Page 28: BLANK HACCP STUDY

Stage 8 ESTABLISHING CRITICAL LIMITS FOR EACH CCP (Principle 3)

The HACCP team shall establish specific and measurable critical limits appropriate for each CCP Critical limits that can be measured quickly and easily shall be used Measurements can include sensory examination mass measurements temperature measurements time moisture level PH value and chemical analysis

Records shall be kept

Establish critical limits for each CCP

Critical limits must be specified and validated for each CCP Criteria often used include measurements of temperature time moisture level pH water activity and sensory parameters such as visual appearance In the case of mycotoxins for example they may include the moisture content or the temperature of the commodity All critical limits and the associated permissible tolerances must be documented in the HACCP Plan Worksheet and included as specifications in operating procedures and work instructions

ie Critical limits have to be established for all critical components associated with each hazard that is controlled by a CCP

Critical Limits must meet or exceed relevant regulatory and program requirements Some establishments set critical limits to exceed regulatory requirements This is acceptable but the establishment should be made aware that if these limits are the ones written into the HACCP plan the inspection will be conducted against these more stringent limits

Critical limits normally include measurements such as temperature time moisture level pH aw available chlorine and sensory attributes When applicable compare the critical limits found the establishment HACCP plan to those considered standard industry practice

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For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

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upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

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8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

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81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

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acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

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Page 29: BLANK HACCP STUDY

For Critical Limits without regulatory or program requirements the company must validate that the critical limits in its plant specific HACCP plan are appropriate This could include product sampling and laboratory analysis and should be relevant to the hazard being addressed

Stage 9 ESTABLISHING A MONITORING SYSTEM FOR EACH CCP (Principle 4)

The HACCP team shall establish a monitoring system to ensure that control of the CCP is effective

The control measures established as part of the monitoring system shall be such that they can confirm that all CCPs are under control

The following shall be addressed in establishing the monitoring system

a) Responsible person or equipment Responsibilities and authorities for the monitoring of a specific CCP shall be identified This person or equipment shall have the knowledge or compatibility to ensure effective monitoring of the CCP A person shall be given the responsibility and authority to take the necessary corrective action when the specified critical limit of the CCP is exceeded A responsible person other than the person doing the monitoring shall verify records associated with the monitoring of a CCP Equipment used for the monitoring of a CCP shall be calibrated

b) Frequency of monitoring The frequency of monitoring shall be specified The frequency shall be adequate to ensure the control of the CCP

c) Monitoring methodology A detailed description shall be given to indicate precisely haw the monitoring shall be done

Records shall be kept to prove effectiveness of the monitoring system

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs owing to the fact that it can be time consuming and that there are problems related to the detection of contaminants

Establish a monitoring procedure

Monitoring is a scheduled observation or measurement of a CCP and its limits The purpose of monitoring is two-fold to assess whether a CCP is under control and to generate data that will be used to produce an accurate record for future verification Monitoring procedures should be accurate and done at appropriately established frequency

Monitoring can be carried out by observation or by measurement on samples taken in accordance with a statistically based sampling plan Monitoring by visual observation is basic but gives rapid results and can therefore be acted

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upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

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8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

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81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

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acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

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Page 30: BLANK HACCP STUDY

upon quickly The most common measurements taken are time temperature and moisture content

Visual observations are usually based upon a predetermined inspection checklist which usually involves observing temperatures or cleanliness of equipment Chemical testing may include measuring pH or acidity or sanitizer levels Sensory monitoring involves examining raw materials for off doors presence of moulds or other defects

Microbiological testing has a limited but important role due to the time delay involved for results While it is not possible to use microbial data to stop a process on the spot or to bring a CCP under control microbial testing is used to setmaintain acceptance standards on raw materials and ingredients in hazard analysis Microbial data may also be used in HACCP verification (see Principle 7)

Stage 10 ESTABLISHING CORRECTIVE ACTION PLANS (Principle 5)

The HACCP team shall establish corrective action plan for each CCP when monitoring of the critical limits indicates deviation from the limits The responsibilities for and manner of disposal of the unsafe service shall be clearly identified

Records shall be kept of all corrective action

Establish corrective action

If monitoring indicates that critical limits are not being met thus demonstrating that the process is out of control corrective action must be taken immediately The corrective action should take into account the worst case scenario but must also be based on the assessment of hazards risk and severity and on the final use of the product Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action

Corrective actions must ensure that the CCP has been brought back under control They must also include appropriate disposition of any affected commodity or product Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition

Ref Please refer to the BLANK CORRECTIVE ACTION PROCEDURE ndash (HACCP MASTER MANUAL)

Stage 11 ESTABLISHING VALIDATION VERIFICATION AND REVIEW PROCEDURES(Principle 6)

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8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

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81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

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acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

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Page 31: BLANK HACCP STUDY

8121 Validation

81211 Validation activities shall include actions to confirm that

a) the established critical limits for CCPs are capable of achieving the intended control of the food safety hazards for which they are designated and

b) the control measures are effective and capable of ensuring control of the identified food safety hazards to be able to obtain end services that meet the defined levels of acceptance

81212 If validation results show that one or more of the above elements cannot be confirmed the relevant elements shall be modified and reassessed

Verify the HACCP plan

Once the HACCP plan has been drawn up and all of the CCPs have been validated then the complete plan must be verified Once the HACCP plan is in routine operation it must be verified and reviewed at regular intervals This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined and the extent and effectiveness of monitoring can be verified Microbiological andor alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date as well as representing an essential verification activity

Ways in which the system can be verified include

1 collecting samples for analysis by a method different from the monitoring

procedure

2 asking questions of staff especially CCP monitors

3 observing operations at CCPs

4 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

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81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

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acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

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Page 32: BLANK HACCP STUDY

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Key Terms Validation Validation is that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards

Verification Verification means those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 35 of 45 Rev 0

found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

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81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 43 of 45 Rev 0

acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 45 of 45 Rev 0

Page 33: BLANK HACCP STUDY

INTRODUCTION

Validation is the process of making sure that a HACCP plan as designed is effective in controlling hazards that may result in illness or injury The validation process primarily involves reviewing a plan to ensure that

1) all of the necessary components of the written plan have been included and that

2) the information and protocols are effective in preventing eliminating or significantly reducing the hazards if properly implemented

Industry has the primary responsibility for validating their HACCP plans to ensure that all components have been included in the plan and that it can effectively control the identified hazards as designed The regulatory authority is responsible for reviewing and validating mandated plans prior to implementation and approval

The Validation Process

Before validating the HACCP plan(s) the regulator should review the compliance history of the food establisment to ensure all HACCP prerequisites have been addressed (SOPs GRPs)

When validating a plan the reviewer is using the principles of HACCP to verify that items including but not limited to the following have been properly identified

1 Product or process (flow chart)2 Hazards3 Selection of CCPs4 Critical limits monitoring procedures corrective actions and verification

procedures for each CCP selected5 Verification (validation) procedures to ensure that the plan is updated and

validated as needed by the HACCP plan administrator6 Recordkeeping procedures and forms7 Employee training

In some cases it may be necessary to request additional information such as product formulation physical facility layout standard operating procedures and scientific documentation or laboratory data for performance standards

WRITTEN HACCP PLAN REVIEW

The regulatory review of the written HACCP plan should be carried out by the regulator to verify that each HACCP plan is complete The model HACCP Plan Review Application which is to be completed and signed by the operator can be used by the regulatory authority to facilitate the validation process

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In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

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NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

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found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

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81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

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81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

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The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

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HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

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An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 41 of 45 Rev 0

Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 43 of 45 Rev 0

acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 44 of 45 Rev 0

process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 45 of 45 Rev 0

Page 34: BLANK HACCP STUDY

In order for a documented HACCP plan to be considered complete it must be dated and signed by the designated person in charge or HACCP coordinator It must also meet all regulatory requirements and include all required components of a HACCP plan

When any section of the written plan is found to be incomplete the deficiencies should be described in the Comments section of the HACCP Plan Review Application Reasons for noted deficiencies (ie regulations laboratory results scientific data etc) should also be included When all the items on the HACCP plan have been evaluated the overall assessment of the written plan is complete

If the HACCP plan documentation package is found to require further information or modification the components which are not acceptable should be returned to the establishment with a cover letter explaining the deficiencies

The establishment is responsible for correcting all deficiencies and resubmitting the amended HACCP Plan to the regulator for follow-up review

When the regulator is satisfied that all deficiencies have been corrected or that the initial plan is acceptable and the operator has informed the regulatory authority of the implementation date the HACCP plan validation process is complete

Below is an example of an APPROVAL OF A HACCP PLAN ndash FLOW CHART for the process of both validation and on-going verification of the Plan

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 34 of 45 Rev 0

NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 35 of 45 Rev 0

found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 36 of 45 Rev 0

81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 37 of 45 Rev 0

81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 38 of 45 Rev 0

The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 39 of 45 Rev 0

HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 40 of 45 Rev 0

An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 41 of 45 Rev 0

Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 42 of 45 Rev 0

2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 43 of 45 Rev 0

acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 44 of 45 Rev 0

process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 45 of 45 Rev 0

Page 35: BLANK HACCP STUDY

NB Regulatory Approval = Validation + Verification

ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS

A Product Description

1 All individual products are identified by brand name andor common name in the HACCP plan (Like products are grouped in an acceptable manner)

2 Characteristics of the product(s) which are important to ensure its safety are listed eg pH and aw The characteristics must be similar for all products covered by the HACCP plan(s)

These characteristics are critical in controlling any common food safety concerns Products with different characteristics cannot be grouped For example reduced oxygen packaged foods cannot be grouped under the same HACCP plan as sushi because the product characteristics are different

3 Description of how the product is to be used eg raw ready to eat ready to cook etc

4 Packaging material and packaging conditions used for the product(s) are identified

5 Anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures

If the determined shelf life of the product exceeds industry practices laboratory data or scientific studies the establishment must provide sufficient background data to support the safety of the chosen shelf life In this case any reference documents must be made available at the time of review

6 Safe handling and usage information pertinent to the product is indicated eg ldquokeep refrigeratedrdquo best ldquouse byrdquo date etc

7 If applicable the HACCP plan includes a description of any specialcontrols required during shipping and storage ie temperature requirements

8 Labelling information for each product is available The sample label is

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 35 of 45 Rev 0

found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 36 of 45 Rev 0

81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 37 of 45 Rev 0

81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 38 of 45 Rev 0

The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 39 of 45 Rev 0

HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 40 of 45 Rev 0

An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 41 of 45 Rev 0

Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 42 of 45 Rev 0

2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 43 of 45 Rev 0

acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 44 of 45 Rev 0

process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 45 of 45 Rev 0

Page 36: BLANK HACCP STUDY

found to be consistent with Product Name Intended Use Safe Labelling Instructions and Special Distribution Control on the HACCP plan

10 When applicable recipes are available upon request to determine if the formulationmethod of preparation is consistent with those submitted with the HACCP plan

11 When applicable a floor plan showing the layout of the preparation area

12 When applicable a brief description of the lot identification system

B Incoming Materials

1 All ingredients incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed

2 Hazard analysis is one of the most important steps in developing aHACCP plan A wrong or faulty hazard analysis will significantly jeopardize the effectiveness of the HACCP plan

The establishment should evaluate hazards of significance and preventative measures needed for each food product and process All hazards associated with incoming materials and ingredients should be specifically identified as biological chemical or physical in the HACCP plan The hazards must at least include those that are commonly associated with a specific product

It may be necessary to use a variety of sources to gather information Some of those sources could include scientific literature regulations and other regulatory guidelines laboratory records and product specifications

C Validation of NewModified HACCP Plans

Where an establishment has added a new process requiring an additional HACCP plan or modification of the existing one the HACCP plan will require a full validation review

The newmodified HACCP plan must be submitted to the responsible regulator in a timely manner

As in the case of the initial validation process the newmodified HACCP plan must be in operation prior to the verification audit

8122 Verification

81221 The HACCP team shall establish a system for the verification of all HACCP procedures and records Verification and auditing methods procedures and tests including random sampling and analysis shall be used as appropriate to determine the effectiveness of the HACCP system

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 36 of 45 Rev 0

81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 37 of 45 Rev 0

81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 38 of 45 Rev 0

The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 39 of 45 Rev 0

HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 40 of 45 Rev 0

An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 41 of 45 Rev 0

Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 42 of 45 Rev 0

2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 43 of 45 Rev 0

acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 44 of 45 Rev 0

process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 45 of 45 Rev 0

Page 37: BLANK HACCP STUDY

81222 Regular internal audits shall be scheduled and conducted to ensure that the HACCP system conforms to the planned arrangements and the CCP monitoring system and that the corrective action plans are affective All processes relevant to the HACCP system shall be audited

81223 The audit criteria scope frequency and methods that form part of the audit programme shall be defined and documented Selection of auditors and conduct of audits shall be such that objectivity and impartially are ensured during the audit process

Records shall be kept of validations and verifications

8123 HACCP plan review

81231 The HACCP team shall establish a procedure for the review of the HACCP plan This procedure shall include events that will automatically trigger a HACCP plan review (internal and external factors should be considered) The HACCP plan shall be updated after such a review The review may lead to a reduction inor the addition of CCPs or the inclusion of additional critical limits in order to improve the HACCP plan

81232 The following potential events can influence food safety and shall automatically trigger a HACCP plan review

a) any report from the marketplace that indicates a health or spoilage risk associated with the service (customer and consumer complaints)

b) an anticipated change in customer and consumer use

c) a change in raw materials or service formulation

d) a change in food handling process activities

e) a change in food handling organization layout and environment

f) any modification to food handling equipment

g) a change in the cleaning and disinfection programme

h) a change in the packaging storage and distribution system

i) changes to staff levels and responsibilities

j) changes to staff levels and responsibilities

k) results of validation and verification activities and

l) any changes pertaining to PRPs

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 37 of 45 Rev 0

81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 38 of 45 Rev 0

The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 39 of 45 Rev 0

HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 40 of 45 Rev 0

An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 41 of 45 Rev 0

Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 42 of 45 Rev 0

2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 43 of 45 Rev 0

acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 44 of 45 Rev 0

process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 45 of 45 Rev 0

Page 38: BLANK HACCP STUDY

81233 Records of HACCP plan reviews shall be kept and the results shall be discussed at management reviews

INTRODUCTION

A working HACCP system is dynamic and flexible and allows for change It should have provisions for verification of its effectiveness

Verification is a process designed to

1048707 Review the HACCP plan1048707 Establish whether the CCPs and CLs are being adequately controlled and

monitored1048707 Determine if the procedures for product deviations and record keeping are being

followed correctly

Verification involves actual observation of procedures and a thorough review of records The verification team should be clearly identified and empowered On-going verification should be on a well-defined and established frequency ie once per shift daily weekly etc However a comprehensive HACCP system verification should be conducted at least annually or whenever there is a change in the HACCP system If the results of that comprehensive verification identify deficiencies the HACCP plan must be modified as necessary to ensure the HACCP plan is controlling the hazards

The Verification Process

1 Verification procedures exist for each CCP

2 Verification procedures must be complete (Who What When and How)

This may include review of operations amp records and analytical testing

3 Verification procedures ensure that the CCP is valid and effective (ie critical limits monitoring procedures and corrective action procedures are appropriate to ensure food safety)

Examples of on-going verification activities include

Calibration of monitoring equipment Direct observations of monitoring activities and corrective actions Record Review

Record Keeping

The following should be identified in the written HACCP plan

bull Corrective actionsbull Records (including name and location)bull Verification

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 38 of 45 Rev 0

The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 39 of 45 Rev 0

HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 40 of 45 Rev 0

An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 41 of 45 Rev 0

Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 42 of 45 Rev 0

2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 43 of 45 Rev 0

acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 44 of 45 Rev 0

process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 45 of 45 Rev 0

Page 39: BLANK HACCP STUDY

The requirement to record events at CCPs on a regular basis ensures that preventive monitoring is occurring in a systematic way Unusual occurrences must be corrected and recorded immediately with notation of the corrective action taken

The level of sophistication of the record keeping necessary for the food establishment is dependent on the complexity of the food preparation operation

For example a sous-videacute process or cook-chill operation for a large institution would require more record keeping than a limited menu cook-serve operation The simplest effective record keeping system that lends itself well to integration within the existing operation is best

Plan Review and Revalidation

The operator is required to review the HACCP plan on a yearly basis to verify that it is effective over time Whenever significant changes are made in any of the following areas they must be incorporated into the HACCP plan the HACCP plan must be revalidated

Products added Formulations changed Processes or packaging added or changed Menu items added Suppliers customers equipment or facilities changed Regulatory requirements changed Introduction of new technologies that may impact food safety

Review procedures must be written and include

a What is reviewedb The specified frequency for the reviewc Person responsible for the reviewd Person responsible for making necessary changes to the HACCP plan

Records must be kept to show that reviews are performed as written and to identify changes made to the HACCP plan These records must include

a A description of the changesb Where the changes are located in the HACCP systemc The date changes took placed Person responsible for verifying and if necessary validating the changes

ADDITIONAL INFORMATION

Revalidation of the HACCP plan includes a documented on-site review and verification of all flow diagrams and CCPs in the HACCP plan

a On-going field verification of the HACCP plan is conducted by the regulatory authority Verification is necessary to ensure that the validated

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 39 of 45 Rev 0

HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 40 of 45 Rev 0

An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 41 of 45 Rev 0

Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 42 of 45 Rev 0

2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 43 of 45 Rev 0

acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 44 of 45 Rev 0

process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 45 of 45 Rev 0

Page 40: BLANK HACCP STUDY

HACCP plan reflects current establishment conditions and that it is functioning effectively

b The written HACCP plan must be validated and accepted as complete before the field verification inspection takes place

c The model HACCP Field Verification Report Form can be used by the regulatory agency in conjunction with the inspection report form to facilitate the verification process The form can be easily completed by the regulator while validating the plan

d In addition the HACCP plan must be in operation prior to the verification inspection In some cases the regulatory authority may feel it necessary to conduct a pre-operational inspection to verify physical facilities and equipment requirements

Such verification activities may include

1 Review of the HACCP plan

2 Record review

3 Review of corrective actions and their resolution

4 Review of critical limits to ensure adequacy for controlling hazards

5 Direct observation or measurement at a CCP

6 Sample collection and analysis to determine the product meets all safety

standards

7 On-site observations of activities carried out by the responsibleemployees

8 Review of modifications of the HACCP plan

Verification of the validated HACCP plan will be made for each CCP This assessment is made after record review and on-site observations have been completed The HACCP plan should not be accepted as final until the field inspector is confident that all requirements of the validated HACCP plan have been fulfilled Failure to comply with the approved procedures must be documented on an inspection report form

When any section of the validated HACCP plan does not comply with findings noted during the field inspection the deficiencies should be noted on the HACCP Field Verification Report Form as well as on the inspection report form cover sheet Deficiencies should also be described on the narrative section of the food establishment inspection report form which serves as an order for correction (ie regulations laboratory results scientific data etc)

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 40 of 45 Rev 0

An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 41 of 45 Rev 0

Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 42 of 45 Rev 0

2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 43 of 45 Rev 0

acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 44 of 45 Rev 0

process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 45 of 45 Rev 0

Page 41: BLANK HACCP STUDY

An emergency suspension of operations may need to be considered by the regulatory authority if significant non-compliance with monitoring of critical control points is noted

When the regulator is satisfied that all deficiencies have been corrected or that the components of the validated plan match findings noted during the field inspection the HACCP plan approval process is complete The HACCP Field Verification Report Form should be dated and signed by the reviewer for the record

An inspection frequency should then be established

Elements of the HACCP Plan Verification Procedures

1 Record Keeping Procedures

The first step in the verification process is to review the records

This is usually done in the office The approved HACCP Plan and associated records must be on file at the food establishment and available for review

Records must be kept to show that CCPs are properly controlled The establishmentrsquos HACCP plan must specify which records are in place for monitoring corrective action and verification procedures for each CCP

Records documenting the monitoring of CCPs and their critical limits could include the recording of actual times temperatures or other quantifiable values as described in the establishmentrsquos HACCP plan the calibration of monitoring instruments corrective actions including all actions taken in response to a deviation verification procedures and results and product code(s) product name or identity Each of these records shall include the date the record was made

Monitoring records should be retained at the establishment for a minimum of one year or for the extent of the shelf life of the product if it exceeds one year and are available upon request

Generally the following are examples of documents that can be included in the total HACCP system

A List of the HACCP team members and assigned responsibilities

B Description of the product and its intended use

1 IngredientsSupplier certification and letters of guarantee documenting compliance with establishment and regulatory requirements

2 PreparationRecords from all monitored CCPs

3 Packaging

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 41 of 45 Rev 0

Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 43 of 45 Rev 0

acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 44 of 45 Rev 0

process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

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Records indicating compliance with specifications of packaging materials and sealing specifications

4 Finished producta Sufficient data and records to establish the efficacy of

barriers in maintaining product safetyb Sufficient data and records establishing the safe shelf-life of

the product if age of product can affect safetyc Documentation of the adequacy of the HACCP procedures

from an authority knowledgeable of the hazards involved and necessary controls

5 Storage and distributiona Temperature recordsb Records showing no product shipped after shelf life date on

temperature-sensitive productsc Flow chart indicating CCPsd Hazards associated with each CCP and preventive

measurese Critical limits and preventive measuresf Monitoring records

All monitoring activities are recorded and signed by the person doing the monitoring on a timely basis They are up-to-date and complete for each CCP

Records show that the monitoring procedures are carried out as described in the validated HACCP plan and that they are effective

g Corrective action plans for deviations from critical limits

Validation records and modification to the HACCP plan indicating approved revisions and changes in ingredients formulations preparation packaging and distribution control as needed

All deviations and the resulting corrective actions are recorded and initialled by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the corrective action procedures are carried out as described in the validated HACCP plan and that they are effective

h Verification proceduresAll verification activities are recorded and signed by the responsible person on a timely basis They are up-to-date and complete for each CCP Records show that the verification procedures are carried out as described in the validated HACCP plan and that they are effective

i Employee trainingRecords indicating that food employees responsible for implementation of the HACCP plan understand the hazards controls and procedures These records should indicate the training courses completed by each employee

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 42 of 45 Rev 0

2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 43 of 45 Rev 0

acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 44 of 45 Rev 0

process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

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2 Flow Chart and Facility Layout Diagram

On-site verification is performed to confirm that the flow chart is accurate in relation to hazard identification and conforms to all aspects of the validated HACCP plan The facility layout diagram must also be accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns

3 RecipesFormulationsMethod of Preparation

Assessment is made for completeness of the product description and to ensure that the establishment is following its written procedure When possible this review should take place while the product is being prepared

Obtain the recipeformulationmethod of preparation that corresponds to the validated HACCP plan

If a deviation is found stop and ask the company to review all its formulationmethods of preparation for this HACCP plan

4 Incoming Materials

Compare actual ingredients and incoming materials to the establishments HACCP plan This will include raw materials product ingredients processing aids and packaging materials

5 Labels

Randomly select one or more labels covered by the HACCP plan Inspect the label(s) to ensure it matches the written product descriptionIf a deviation is found select at least one more label If an additional deviation is found stop and ask the company to review all its labels for this HACCP plan

6 Monitoring Procedures

Monitoring procedures must be defined for each critical limit at each CCP to make sure the CCP is under control Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits reason amp importance of the monitoring of this CCP and how to perform the related monitoring procedures including record keeping

Monitoring procedures are to be ongoing at all times during processing and must be done in a location that accurately reflects the critical limit In some cases the frequency of monitoring reflects regulatory requirements (eg visual examination of packaging for proper vacuum seal)

Results of monitoring procedures must be readily available and give information on a timely basis allowing a decision to be made on the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 43 of 45 Rev 0

acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 44 of 45 Rev 0

process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

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acceptability of the product and conformance to the validated HACCP plan

Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT QUESTIONNAIRE

Stage 12 ESTABLISHING RECORD KEEPING AND DOCUMENTATION (Principle 7)

8131 Document control

The HACCP team shall ensure that a procedure for document control is established The document control procedure shall address at least the following

a) Approval of documents for adequacy before being issued

b) review and update of documents as necessary and re-approval of thesedocuments

c) identification of changes to documents and the current revision status

d) ensure that the current versions of applicable documents are available atpoints of use

e) ensure that documents are legible and readily identifiable

f) ensure that documents of external origin are identified and theirdistribution controlled and

g) prevention of the unintended use of obsolete documents and applicationof suitable identification to them if retained for any purpose

A method of control for identification of the latest versions of all documents shall be established

8132 Records control

The HACCP team shall ensure the establishment of a procedure for the control of records The procedure shall address the identification collection storage protection retrieval retention times and disposal of such records

Records shall be legible easily retrievable and accessible and shall provide evidence of conformance to the requirements of the HACCP system

Keep record

Record keeping is an essential part of the HACCP process It demonstrates that the correct procedures have been followed from the start to the end of the

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 44 of 45 Rev 0

process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

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process offering product traceability It provides a record of compliance with the critical limits set and can be used to identify problem areas

Records that should be kept include all processes and procedures linked to GMP monitoring deviations and corrective actions

Documents should also include those that recorded the original HACCP study eg hazard identification and selection of critical limits but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken Record keeping can be carried out in a number of ways ranging from simple check-lists to records and control charts Manual and computer records are equally acceptable but a documentation method should be designed that is appropriate for the size and nature of the enterprise

Please refer to the Documentation Control and Records Control Procedures ( HACCP MASTER MANUAL )

~ end ~

BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 09 2010 Page 45 of 45 Rev 0