sample_iso_22000_manual.pdf

7/30/2019 SAMPLE_ISO_22000_Manual.pdf

1/84

Important aspects to be kept in mind while preparing Food Safety &

Quality Manual:

Policy: Organizations policies to be framed

Organizations overall and departmental Quality Objectives in measurable terms to beframed

Identifying the positions and competencies (education ,relevant experience) neededfor performing the work to be documented

Recruiting the personnel meeting the requirements as documented above Organization chart and roles & responsibilities to be documented Total layout of the plant in building to be kept including men and material movement Identifying each machine in plant and preparing inputs to the machine and output

from the machine to be documented

Process flow chart for manufacturing process from raw material inputs to the finishedproducts and its storage and dispatch to be documented

Training programs needed to the personnel as per manufacturing processes andprocessing of training as per these documented requirements to be ensured Handling of customer complaints on the products and its mechanism to be

documented

Ensure that all the requirements of the respective standard is addressed in themanual. To ensure this it is better to prepare a matrix indicating the requirements on

the one side and compliance documents in the manual can be given

Normally the following procedures will be documented irrespective of the standardbeing implemented.

Document control


2/84

Control of records Recruitment of personnel Training of personnel Management review meeting Internal audits Handling customer complaints Corrective action Preventive action

Handling of potentially unsafe product / non conforming product

Verification & validation Raw material and finished product specifications has to framed Procedure for supplier evaluation

eFresh Portal made an effort to prepare a Food Safety Manual Structure based

on HACCP guidelines, which is generic and the same can be considered as a first

step towards preparation of the Food Safety Manual and incorporating the

requirements as applicable in individual case.


3/84

SAMPLE -FOOD SAFETY

MANAGEMENT SYSTEM MANUAL

ISO 22000:2005

Prepared by: Approved by:

Effective from:

TABLE OF CONTENTS

S. No Documents Document No Clause No. Pages

1 Contents FSMS C -

2 Abbreviations FSMS-A -

3 Company Profile FSMS C P -

4 Declaration FSMS D -

5 Distribution List FSMS DL -

6 Amendment List FSMS AL -

7 Recognitions/Licenses by Govt. Agencies FSMS R -


4/84

8 Scope of the FSMS FSMS S 01

9 References FSMS R 02

10 Terms and Definitions FSMS TD 03

11 Documentation Requirement FSMS DR 4.2

12 Control of Documents FSMS CD 4.2.2

13 Control of Records FSMS CR 4.2.3

14 Management Responsibility FSMS MR 5.015 Food Safety Policy FSMS FSP 5.2

16 FSMS Planning FSMS FSMSP 5.3

17 Responsibility & Authority FSMS RA 5.4

18 Food Safety Team Leader FSMS FSTL 5.5

19 Communication FSMS C 5.6

20 Emergency Preparedness & Response FSMS EPR 5.7

21 Management Review FSMS MR 5.8

22 Resource Management FSMS RM 6.0

23 Competence Awareness & Training FSMS CAT 6.2.2

24 Training & Training Plan FSMS T&TP 6.2.2.325 Infrastructure & Work Environment FSMS IWE 6.3-6.4

26 Planning & Realization of Safe Product FSMS PRSF 7.0

27 Pre- Requisite Programs FSMS PRP 7.2

28 Pre. Steps to Enable Hazard Analysis FSMS PSEHA 7.3

29 Product Characteristics FSMS PC 7.3.3

30 Intended Use FSMS IU 7.3.4

31 Flow Diagram FSMS FD 7.3.5

32 Hazard Analysis FSMS HA 7.4

33 Hazard Assessment FSMS HA 7.4.3

34 Control Measures FSMS CM 7.4.4

35 Operational PRPs FSMS OPRP 7.5

36 HACCP Plan FSMS HP 7.6

37 Updating-Verification- Traceability FSMS UVT 7.7-7.8-7.9

38 Control of Non-Conforming Product FSMS CNCP 7.10

39 Validation, Verification & Imprv. of FSMS FSMS VVIF 8.1-8.2

40 Control of Monitoring and Measurement FSMS-CMM 8.3

41 FSMS verification FSMS-FSMSV 8.4

42 Improvement FSMS-I 8.5


5/84

ABBREVIATIONS

ABBREVIATION EXPANSION

ACCT ACCOUNT

ADMN ADMINISTERATION

AMDT AMMENDMENT

AMT AMOUNT

ANNX ANNEXURE

APPX APPENDIX

ATT ATTACHMENT

BAL BALANCE

B/F BROUGHT FORWARD


6/84

BIO BIOLOGICAL

C CONSEQUENCES

CP CONTROL POINT

CCP CRITICAL CONTROL POINT

CHEM CHEMICAL

CONTD CONTINUED

DT DATE/ DATED

EFF EFFECTIVE

ENCL ENCLOSURE/ ENCLOSED

FSM FOOD SAFETY MANUAL

FSMS FOOD SAFETY MANAGEMENT SYSTEM

FSSP FOOD SAFETY STANDARD PROCEDURES

FSTL FOOD SAFETY TEAM LEADER

GMP GOOD MANUFACTURING PRACTICES

/C INCHARGE

HACCP HAZARD ANALYSIS AND CRITICAL CONTROL POINT

HR HUMAN RESOURCE

DEN IDENTIFICATION

NFRA INFRASTUCTURE

SO INTERNATIONAL ORGANIZATION FOR STANDARDIZATION

L LIKELIHOOD

MAINT MAINTENANCE

MAX MAXIMUM

MIN MINIMUM

OPRP OPERATIONAL PRE-REQUISITE PROGRAMS


7/84

PHY PHYSICAL

PRP PRE-REQUISITE PROGRAMS

PREP PREPERATION

P & S PROCUREMENT & SUPPLIES

PROD PRODUCTION

QC QUALITY CONTROL

QMS QUALITY MANAGEMENT SYSTEMS

QTY QUANTITY

R RISK

SOP STANDARD OPERATING PROCEDURES

SSOP STANDARD SAFETY OPERATING PROCEDURES

STD STANDARD

SUPVSR SUPERVISOR

TPT TRANSPORT

VR VOUCHER

WE WORK ENVIRONMENT

WT WEIGHT

YR YEAR


8/84

AMENDMENT LIST

l.

No

Document

Name

Document

Number

Date of

Amendment

Clause No. Reason for Change Authorization


9/84

COMPANY PROFILE

About Company: Should cover Geographical details Number of branches if any About production facility

At this hotel, all three meals are served Breakfast, Lunch and Dinner. Variety of cuisines - SouthIndian, North Indian and International with both Vegetarian and Non-Vegetarian options are

prepared at the Kitchen and served in the Cafe. The Kitchen also has a live counter where Pizzasand Pastas are made to order with options. The Menus are displayed in the restaurant so that

guests get to know the options available for the day.

At this hotel, we are committed to making constant improvements to the quality and hygienestandards of the food served to our guests.


10/84

DECLARATION

XYZ Hotels brings out this Food Safety Management System Manual as part of the food safety system under

he authority of the Manager. This Manual is the original and authenticated one and the activities detailed

n this Manual are true and correct. This FSMS Manual is in compliance with the international standard, ISO

22000:2005 which it is based on. The criteria outlined in this Manual are mandatory and shall be complied

with by all the facility staff of this hotel.

Any changes or modifications to be incorporated in this manual shall be made only upon authorization by

he MR and the details of the modifications by the food safety team leader will be indicated in the record ofAmendments.

Date:

Signed by: MR

Signature:


11/84

DISTRIBUTION LIST

The Controlled copies of the FSMS Manual are distributed to the following holders:

Controlled copy no. Authorized Holders

01 Executive Chef

02 Manager QC03 Manager (F & B)

The MR holds the Master Copy of the FSMS Manual.

AMENDMENT LIST

Sl.

No

Document

Name

Document

Number

Date of

Amendment

Clause

No.

Reason for

Change

Authorization

1

2

RECOGNITIONS / LICENSES BY GOVERNMENT AGENCIES


12/84

a. Form of License No. (PFA)

SCOPE OF THE FSMS

The FSMS system in xyz is applicable to the activities undertaken in the food service establishment at,

Hyderabad. The scope is as follows:

Food Production and service

ISO 22000:2005 SYSTEM

We have developed an ISO 22000 based Food Safety Management System which assures the safety of mealsprepared at xyz premises .Process control plans developed and operated for all aspects that are applicable

o the safety of foodstuffs are described/ referenced in the appropriate ISO 22000 Food Safety Systemdocumentation.

The Scope of the ISO 22000 System at xyz has been defined as per the position within the food chain, as perprocess location and line, and per product and includes all classes of hazards viz. Physical, Chemical &

Biological.

REFERENCES

Food Safety Management Systems Requirements for organizations through out the food chain. ISO22000 : 2005

Joint FAO/WHO Codex Alimentarius Commission


13/84

General Principles of Food Hygiene, CAC/RCP 1-1969, Rev. 4 (2003), amended 2003. Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application,

Annex to CAC/RCP 1-1969, Rev. 4 (2003).

The Prevention of Food Adulteration [PFA 1954 Act]

TERMS AND DEFINITIONS

Action-limit value - A value for the product or process parameter under consideration, deducedfrom the critical limit value, which indicates that an intervention in the process is required.

Aspect- An element of the food business operation (products, processes, PRP, services) that caninteract with the food safety.

Cleaning - Removal of soil, food residue, dirt, grease or other objectionable matter


14/84

Contaminant - Any biological or chemical agent, foreign matter, or other substances notintentionally added to food which may compromise food safety or suitability

Contamination - Introduction or occurrence of a contaminant in food or food environment. Control (verb) - To take all necessary actions to ensure and maintain in compliance with criteria

established in the Food Safety Plan.

Control (noun)- The state wherein correct procedures are being followed and criteria are beingmet.

Control measure- Any action and activity that can be used to prevent or eliminate a food safetyhazard or reduce it to an acceptable level.

Control measure, general- A measure to control a specific part of the PRP. Control measure, specific- A measure to control a CCP.

Corrective Action - Any action to be taken when the result of monitoring at the CCP indicate a lossof control.

Critical Control Point (CCP) - A step at which it is essential that a specific control measure isapplied to prevent or eliminate a Food Safety Hazard or reduce the risk to an acceptable level.

Critical Limit- A criterion, which separates acceptability from unacceptability. Note- This criterion defines the limiting values for the product or process parameters under

consideration for monitoring (see action- limit vales and target value).

Disinfection - The reduction, by means of chemical agents and/or physical methods, of the numberof micro-organisms in the environment, to a level that does not compromise food safety or

suitability

Establishment- Any building or area in which food is handled and the surroundings, under thecontrol of the same management.

Flow Diagram - A systematic representation of the sequence of steps or operations used in thepreparation, processing, manufacturing, packaging, storage, transportation, distribution, handling

or offering for sale of a particular food item.


15/84

Food business operator- The person or persons responsible for ensuring that the requirements ofthe food legislation are met within the food business under his/ their control.

Food handler - Any person who directly handles packaged or unpackaged food, food equipmentand utensils, or food contact surfaces and is therefore expected to comply with food hygiene

requirements

Food Hygiene All conditions and measures necessary to ensure the safety and suitability of foodat all stages of the food chain.

Food safety - Assurance that food will not cause harm to the consumer when it is prepared and/oreaten according to its intended use.

Food suitability - Assurance that food is acceptable for human consumption according to itsintended use.

HACCP- A system, which identifies, evaluates and controls hazards which are significant for foodsafety.

HACCP audit- A systematic and independent examination to determine whether the HACCP system,including the HACCP plan and related results, comply with planned arrangements, are implemented

effectively and are suitable for the achievement of its objectives.

Note- Examination of the Hazard Analysis is an essential element of the HACCP audit.

Food safety Plan- A document prepared in accordance with the principles of HACCP to ensurecontrol of hazards, which are significant for food safety in the segment of the food chain under

consideration.

HACCP based food safety system (a HACCP system) - The organizational structure, procedures,processes and resources needed to execute the HACCP plan and meet its objectives.

Food Safety Team- Group of individuals (multi- disciplinary) who develop, implement andmaintain a Food Safety Management system.

Hazard - A biological, chemical or physical agent in or condition of, food with the potential to causean adverse health effect.

Hazard Analysis - The process of collecting and evaluating information on hazards and conditionsleading to their presence to decide which are significant for food safety and therefore is addressed

in the Food safety plan.


16/84

Monitoring - The act of conducting a planned sequence of observations or measurements of controlparameters to assess whether a CCP is under control.

Pre-Requisite Program (PRP)- Any specified and documented activity or facility implemented inaccordance with the Codex General Principle of food hygiene, good manufacturing practices and

appropriate food legislation, in order to establish basic conditions that are suitable for the

production and handling of safe food at all stages of the food chain.

Preventive action- Any measure or activity that will be used to prevent, to eliminate or to reducethe recurrence of causes for existing deviations, defects or any other undesired situation with

respect to food safety.

Primary production - those steps in the food chain up to and including, for example, harvesting, Products, unprocessed- Foodstuffs which have not undergone a treatment, including products

which have been, for example, divided, parted, severed, boned, minced, skinned, ground, cut,

cleaned, trimmed, husked or milled, chilled, frozen or deep frozen.

Product, processed- Foodstuffs resulting from the application to unprocessed products of atreatment such as heating, smoking, curing, maturing, pickling, drying, marinating, extraction,

extrusion, etc or combination of these processes and or products; substances necessary for their

manufacture or for giving specific characteristics to the products may be added.

Risk- The probability of causing an adverse health effect caused by the occurrence and the severityof a particular hazard in food when prepared and consumed according to its intended use.

Target value- The value of the product or process parameter(s) to be monitored, targeted withinaction- limit values (the range of acceptable variations) and certainly within critical limit values,

thus securing a safe product.

Step - A point, procedure, operation or stage in the food chain including raw materials, fromprimary production to final consumption.

Validation - Obtaining evidence (in advance) that the specific and general control measures of theFood Safety plan are effective.

Verification - The application of methods, procedures, tests and other evaluation, in addition tomonitoring to determine compliance with the specification laid down in the HACCP Plan and the

effectiveness of the HACCP based food safety system.


17/84

Food Safety Management System Documentation Structure: The documentation structure

onsists of different hierarchical levels as follows:

Food Safety Policy Manual Standard Operating Procedures Work Instructions / operating Rules HACCP Principles related documents Miscellaneous documents Formats and Records

LOGIC SEQUENCE FOR THE APPLICATION OF HACCP


18/84

4.0FOOD SAFETY MANAGEMENT SYSTEM

4.1General requirements:

4.1.1 The Food Safety Management System (FSMS) documented by XYZ in this Food Safety

Management System Manual is established, implemented, maintained and updated as and


19/84

when required and also its effectiveness is continually improved in accordance with the

requirements of ISO 22000:2005.

4.1.2 XYZ has defined the scope of the FSMS as in FSMS Manual Clause1.0 and has identified the

product categories, processes and production sites where this FSMS is implemented.

4.1.3 As part of the FSMS, XYZ has

Ensured that all food safety hazards expected to occur in the products or processes within thescope of activities of the system are adequately identified, evaluated and controlled based on

the HACCP system developed so that the products produced are safe and do not harm the

consumer.

Proper communication (external) throughout the food chain within its scope of activities andpurview with respect to the food safety issues of the products it produces.

Proper communication (internal) throughout the organization regarding the FSMSdevelopment, implementation and updating as required by the standard ISO 22000:2005.

In place FSMS review meetings (once a year) to evaluate and update it on a regular basisand/or whenever required to incorporate the latest information on the hazards associated with

its products and processes which need to be controlled.

4.1.4 XYZ has outsourced some of the processes like external lab services, pest control, water and

other materials and calibration of testing and monitoring devices for machine testing of food

that are identified and are under the control of XYZ.

4.2 DOCUMENTATION REQUIREMENTS

4.2.1 General

The Food Safety Management System documentation consists of

Documented statements of Food Safety Policy and Food Safety Objectives in this FSMS Manual. Food Safety Management System Manual Documented Food Safety Management System Procedures/Food Safety Manual as required by

ISO 22000:2005 and other procedures needed to ensure effective planning, operation and control of

the processes by the organization are included in this FSMS Manual or referenced here as to where

such procedures are documented. Forms and Formatted registers needed to generate records are


20/84

indicated. List of records maintained meeting the requirements of ISO 22000:2005 are also part of

the XYZ documentation requirements.

The FSMS Manual is prepared covering

- Scope of FSMS, covering the exclusions, if any, with justification.Reference to Food Safety Management System Proceduresand Food Safety Manual.

4.2.2 Control of documents

Procedure for Document control is established for effective control of documents defining thefollowing controls

- To approve the documents for adequacy prior to the use.- To review and update as necessary and re approve documents - To ensure that changes and the current revision status of documents are identified.- To ensure that relevant versions of applicable documents are available at points of use.

- To ensure that documents remain legible and readily identifiable.- To ensure that documents of external origin are identified and their distribution

controlled and

To prevent the unintended use of obsolete documents, and to apply suitable identificationto them if they are retained for any purpose.

The documents are updated with PRPs and HACCP plan

4.2.3 Control of records


21/84

Records are considered to be a special type of document, which provide objective evidence tofulfillment of requirements of the Food Safety Management Systems. Effort would be to maintain the

records in the electronic media

Records are established and maintained to provide evidence of conformity to requirements and ofthe effective operation of the Food Safety Management System. The records are maintained in sucha way that they are legible, readily identifiable and retrievable.

At XYZ, the Procedure for Control of records has been established with regard to :- identification- storage- protection- retrieval- retention time- disposition

5.0MANAGEMENT RESPONSIBILITY

5.1Management commitment

The Management of XYZ demonstrates good commitment to the FSMS development and

implementation and continually improve its effectiveness

By communicating the importance of meeting the customer requirements as well as statutoryand regulatory requirements through meetings.

By ensuring establishment of Food Safety Policy By ensuring that Food Safety/Quality Objectives are established By conducting Management Review Meetings. By ensuring that all necessary resources are available to carry out the operations.

5.2 Food Safety Policy


22/84

XYZ has defined and documented its policy with regard to food safety, thereby demonstrating theorganizations commitment to safe food. It is focused on the safety of foodstuffs, and responds to the

expectations and needs of its consumers.

XYZ ensures that the policy & objectives are understood, implemented and maintained at all levelsof the organization. This is done through suitable means like displaying on boards and conductingmeetings, via departmental heads, etc. Employees are advised of the policy & objectives on joiningthe company and/or during trainings. Food Safety Policy forms the basis for formulation of Food

Safety/Quality Objectives.

Food Safety Policy and Food Safety/Quality Objectives are reviewed in Management ReviewMeetings once in 6 monthsto ensure their continuing suitability.

FOOD SAFETY POLICY

Policy statement:

The Food Safety Team in M/S.XYS Company is committed to serving food to its guests prepared under

hygienic and safe conditions.

Our Food Safety Practices shall:

Ensure that only Trained and Skilled staff are inducted into the kitchen Reflect Food Safety Standards in relation to safety practices, premises and equipment

standards

Reinforce consistent food safety practices in the service Aim at providing Safe and Hygienic food Reduce the risk of potential food-borne illnesses Comply with legislative requirements while maintaining a flexible approach to meet the bestpractices Reflects continual improvement in the Food Safety Standards.

This commitment to Food Safety Policy will be demonstrated by the management conforming toFood Safety Management System based on ISO 22000:2005 requirements and the following

objectives as mentioned in the table on the next page.


23/84

Organization Chart

Highlighted is the HACCP team

ManagingDirector

Production

ManagerManager QA Manager

Procurement

Plant

Operators Microbiologist Stores in

charge

visorHygiene

Supervisor

rician Maintenance

in chargeRipening sh

in charg

HR

Manager

SupervisorSupervisor


24/84

Competency of each position in the organization can be documented in the belowformat. Any of the employees working in the organization is not complying with the

requirements set by the organization as per the standard if any, and the

organizations operational requirements, then the position is not confirming to the

requirement.

Therefore it is very important that the organization first determines the competency

requirement of the personnel, as per the operational requirement and then recruit

he people complying with this requirement.

Format for COMPETENCY MATRIX

Sl.

No.

Name of

Employee

Function

/

Designati

on

REQUIRED ACTUAL

Academic

Qualification

Total

Experience

Skill

set

Academi

cQualifica

tion

Total

Experience

Skill

set


25/84

FOOD SAFETY AND QUALITY OBJECTIVES AT FUNCTIONAL LEVELS FOR THE PERIOD OF2011-2012

SS..NNOO FFUUNNCCTTIIOONN OOBBJJEECCTTIIVVEE RREESSPPOONNSSIIBBIILLIITTYY LLEEVVEELL

((FFuunnccttiioonnaall HHeeaaddss))

11 HHRR To give employees, a minimum

of one training program in a

month in handling, processing,

and serving of the safe food.

MMaannaaggeerr QQCC

22 PPuurrcchhaassee // SSttoorreess Nonconforming input materialsnot more than 5% per supplier

of the total consignment permonth

MMaannaaggeerr SSttoorreess

33 PPrroodduuccttiioonn // MMaannuuffaaccttuurriinngg To bring down the wastage of

the food to 5 % of the total

production.

EExxeeccuuttiivvee CChheeff

44 PPrroodduuccttiioonn // MMaannuuffaaccttuurriinngg To monitor and maintain safe

temperatures (>63C) while hot

holding of food.

EExxeeccuuttiivvee CChheeff

66 QQuuaalliittyy AAssssuurraannccee CCuussttoommeerr ccoommppllaaiinnttss:: NNoottmmoorree

tthhaann 55%% ppeerr mmoonntthh

MMaannaaggeerr FF && BB


26/84

5.3

Food Safety Management System Planning

The Top Management of XYZ ensures that

The Planning of the Food Safety Management System is carried out in order to meet therequirements of ISO 22000 standard and Food Safety/Quality Objectives.

The FSMS Planning of XYZ ensures that the requirements (inputs) are clearly documented toultimately meet the acceptance criteria (output).

The FSMS Planning includes or refers to the Flowchart, Worksheets, Quality Control Plans, FoodProduct Specifications/Recipes and Hazard Identification.

The integrity of the Food Safety Management System is maintained when changes to the Food SafetyManagement System are planned and implemented.

On conducting a hazard analysis and Determination of the Critical Control Points (i.e., meeting thefirst two HACCP principles), the HACCP Plan becomes the input for planning activities with focus onwhat areas need control and to what level.

The requirements of the product are analyzed and defined with regard to :- Documentation: Flowchart, Worksheets, Quality Control Plans, Food Product

Specifications/Recipes and Hazard Identification with Critical Control Points

- Equipment: includes the manufacturing / food production equipment- Human resources: All staff has the appropriate skills for the jobs / tasks

- Purchased materials: Availability of the raw materials, ingredients to the specifiedrequirements and manufacturing aids


27/84

5.4Responsibility and Authority

The Organization Chart included in this manual shows the relationships between the respectivefunctions.

All staff and managers are responsible for the quality of their own work and for advising

their respective workers of their work responsibilities, when satisfactory operation of the

FSMS is adversely affected. Staff and managers are responsible and have the authority

within their defined areas of control for:

- The quality of work carried out- Initiating action to prevent the occurrence of product non-conformance- Identifying and recording quality problems- Initiating, recommending and providing solutions to quality problems- Verifying that solutions are effective- Controlling further processing until all conditions are satisfactory

Further details of responsibilities and authorities for personnel who manage and perform thework can be found in the relevant job descriptions or related documents.

In the event of absence, responsibility and authority passes to the next higher level ofmanagement, for subsequent delegation, as appropriate.


28/84

Food Safety Team Responsibilities

Making of the flow charts, their hazard analysis and determination of CCP, conduction of HACCPVerification and Validation.

Ensuring that the HACCP system is operating and maintained inXYZ as per the ISO 22000:2005 standards.

Providing adequate guidance and training to all for carrying out their duties in the raw materialreception, pre-preparation areas, processing areas, raw material stores and all other sections as per

XYZ approved HACCP Plans, procedures, and operating methods.

Effective implementation and monitoring of cleaning schedule and strict personnel hygiene measures inthe XYZ

This is in addition to their existing responsibilities.


29/84

Validation Team Responsibilities

Ensuring the adequacy, completeness, and (scientific) basis of the potential hazards identified andanalysed.

Ensuring that the aspects considered while determining the significance of hazards are evaluatedusing sound scientific and technical knowledge

Ensuring that the control measures (general or specific) are appropriate and adequate to control thehazards

Ensuring that the fluctuations of the control parameters (equivalent to process criteria) within thedefined critical limits will not affect the safety of the product

Ensuring the appropriateness of the control measures monitoring system Ensuring the appropriateness of the corrective action systems defined, w.r.t. preventing the release

of unsafe products, and that they provide evidence that the situation can be corrected immediately.

Ensuring that the Food Safety System is validated first and every time prior to issue. Ensuring that all the validated activities are carried out in time and records of the same are

maintained.

This is in addition to their existing responsibilities.

5.5 FOOD SAFETY TEAM LEADER

Executive Chef of M/s.XYZ Company is the nominated FS Team Leader having responsibility and

authority to


30/84

Ensure that processes needed for the Food Safety Management System are established,implemented, maintained and updated.

Report to the top management on the performance of the Food Safety Management Systemand any need for improvement

Ensure the promotion of awareness of customer requirements throughout the organization. Liaison with external agencies on matters relating to the Food Safety Management System First ensure relevant training and education to FST members To organize internal food safety audits for FSMS and review corrective action if required,

through follow up audits.

5.6. COMMUNICATION

5.6.1 External Communication

XYZ has ensured that appropriate communication processes are established with the customer,Legal Authorities and External Certifying Agencies.

XYZ communicates with the customers in relation to:- Product information.- Customer feedback, including customer complaints through e-mail or verbal means.


31/84

- Customer complaints and feedback are documented and Corrective and Preventive Actions aretaken accordingly.

All the data required for Legal authorities and External certifying agencies is recorded andmaintained separately.

5.6.2 Internal Communication

XYZ ensures that appropriate communication processes are established within the organization andthat communication takes place regarding the effectiveness of the FSMS through:

- Management Review Meetings, minimum once in six months- Notices/Mail.- Circulars

The preventive actions identified under hazard analysis and the food product deviations with therelated dispositions are made known by communicating at the appropriate levels and functions.

At XYZ communication takes place with regard to the following to promote effective operation of theFSMS:

- recipe improvisations / new recipes- changes in raw materials, ingredients- changes in food production, manufacturing systems, equipment and surrounding environment- changes in the requirements (customer, statutory / regulatory)- changes in personnel qualification level and responsibilities- New food safety hazards with the new ways of handling and controlling measures.- Changes in cleaning and sanitation programmes, storage and distribution systems- Complaints indicating food safety hazards associated with the products.

The food safety team ensures that this information is included in the updating of the FSMS. Top management shall ensure that relevant information is included as input to the management

review

The minutes of the Management Review Meetings are maintained by the MR.(Refer Minutes of Management Review meetings) The minutes of meetings are communicated to the participants of the meeting for taking effective

actions and demonstrating continual improvement


32/84

5.7. EMERGENCY PREPAREDNESS AND RESPONSE

Objectives of the PlanTo identify the possible hazard/ risk this can lead to environmental emergency, property damage

and injury to human beings

- To prevent, identified potential environmental, food safety related emergencyscenarios

- To minimize /mitigate consequences wherever possible.- To provide relief to injured persons.- To control the emergency as early as possible.

Potential Emergency Situations.

Location Factors leading toemergency

Hazard Preventive measures

Raw/packingMaterial

torage

Electrical FireBidi/Cigarette Fire

Injury to humanBeings

Air pollutionLand Pollution

Proper connectionsNO SMOKING sign is displayed.

Fire extinguishers & pipelines areprovided

Electrical

ControlPanel Area

Flash due to short

CircuitingOverloading and water

Spillage

Fire

Injury to humanbeings

Air Pollution

Proper connections

Proper load distributionArea to be kept dry

NO SMOKING sign is displayed.

Production

Area

Fire

Manual handling ofchemicalsAccidental spray of hot CIP

SolutionsSteam burns

Water Pollution

Air pollutionInjury to humanbeings

Proper maintenance of pipe

FittingsUse of safety wears etc.


33/84

Kitchen area Fire

Leakage of LPG

Electrical sparksFittings & electrical shortCircuit

Lighted cigarette, match

Sticks.

Fire & explosion

Air pollution

Property damageInjury to humanBeings.

Regular maintenance of gas

Pipe fittings.

NO SMOKING sign isDisplayed.

Fire extinguishers& Pipelines are

provided.

Monitoring of LPG

Admn.block.

Sites of high rise

BuildingPainting/Construction /

Civil work

Slip or fall may lead to an

accident

Injury to human

beings

Safety belt, proper ladder,

Proper scaffolding

Cleaning ofglasses

Slip or fall may lead to anAccident

breakage of glass

Injury to humanbeings

Safety belt, proper ladder

Potential Food Safety EmergencyLocation Factors leading

to emergencyHazard Preventive measures

Production/

Kitchen Area

Bio-terrorism,

sabotage, Bird flu

Injury to

Human Beings

Entry restricted to Production / kitchen area

Security Arrangements in the premises round theclock.Raw materials/commodities are accepted onlyafter proper checking.

Finished Product is released only after properchecking.

Microbiology lab is in the premises; howeverroutine bacteriological used media / culture are

disposed off only after auto-claving.

Service centerPremises

Energy Failure AccidentsProduct Loss &

TimelyDeliveryeffects

Emergency Lights provided at the potential areas.Standby Generator/Transformer.


34/84

Service center

Premises

Flooding Unhygienic

Conditions and

hindrances toproduction.

Proper Maintenance of drainage system &

periodically cleaning.

Additional pumps provided around the premisesto throughout storm water / additional wateroutside the premises.

All the premises is covered with solid brick walls

and entry gates are raised, then the road level tostop entry of water from outside.

Emergency Preparedness:- To deal with fire, the whole premises are equipped with fire extinguisher pipelines and

fittings etc... Which are installed at various locations as per the law.- Majority of the persons in the service centre trained in fire fighting and first aid is displayed

prominently in every department.

- All security guards are trained in fire fighting.- Adequate number of first aid boxes are installed and maintained in the service centre.- All inflammable materials are stored in isolated place and labeled accordingly.- NO SMOKING signs are displayed at all important locations- Intercom facilities are available all over the building for communication with security

department.- Personal protective are kept near potential area by the concerned Section In charge such as hand

gloves, masks etc.

- List of emergency telephone numbers is available in each department. All types of wastages like raw material, packaging material etc is taken by an external agency for disposal of

the same.

Other waste like cooked leftover food items are taken by an external agency for disposal and records aremaintained.

For Product recall from customer please refer clause 7.10.3 (handling of potentially unsafe products)of thismanual

The Food Safety will act as an emergency team in such situations.


35/84

5.8 MANAGEMENT REVIEW

5.8.1 General

Top management reviews the organizations Food Safety Management System at least once in every six

months to ensure its continuing suitability, adequacy and effectiveness. The review includes assessing

opportunities for improvement and the need for changes to the Food Safety Management System,

including the Food Safety Policy and Food Safety Objectives. Records of management review are

maintained.

The members of the Management review committee include:Manager QC

Manager Purchase & storesManager Production

5.8.2 Review input

The input to the Management review meeting includes the following information.

Follow-up actions from previous management reviews Analysis of results of verification activities Changing circumstances that can affect food safety Emergency situations, accidents and withdrawals


36/84

Results of review and system updating activities Communication activities including customer feedback and is reviewed monthly. External audits or inspections

5.8.3 Review output

Output of the management review contains the decisions and actions related to

Assurance of food safety

Improvement of the effectiveness of the Food Safety Management System Resource needs Revision of organizations food safety policy and objectives

Management Representative

The Management Representative, ensures the following: As per standard- To establish, implement and maintain the FSMS as per ISO22000: 2005 Standards.- To ensure that processes needed for the FSMS are established, implemented and maintained

understanding the current and future needs of the customers / clients

- To report to the top management on the continuing suitability and effectiveness of the FSMSand the scope for improvement

- To promote awareness of customer requirements throughout the organization- To plan, schedule and conduct Internal Audits for FSMS- To select qualified Internal Auditors- To review the Audit Report and follow-up Corrective Action / Preventive Action Reports- To initiate modifications of documents based on Corrective action / Preventive Action and tocontrol all the documents related to the FSMS- To schedule management review meetings at the defined intervals and record minutes of

management review meetings for subsequent reporting on the performance / improvements

of the FSMS

- To liaison with the external agencies related to the FSMS Implementation and Certification The Management Representative convenes the management review meetings after preparation of

the agenda and maintains the minutes of the meeting.


37/84

6.0 RESOURCE MANAGEMENT

6.1 Provision of Resources :

Resources (Human resources, Equipment resources and Work environment needs) required forimplementation & maintaining of Food Safety Management System are identified, and determined

by MR for carrying out various activities as per budgeted plan.

Resources are provided to implement and maintain the Food Safety Management System andcontinually improve its effectiveness and enhance customer satisfaction by meeting customer

requirements. Resource requirements are reviewed in Management Review meetings.

The resources include :- Adequate trained personnel for management, performance and verification activities.- input materials of the requisite quality- Suitable process equipment, process control equipment and other infrastructure to meet the

requirements for the quality of the product.- Work environment (physical and human) suitable for operation / processes to meet up

Quantified Quality Objectives.

6.2 HUMAN RESOURCES6.2.1 General

XYZ provides competent personnel for performing work affecting product quality. Competency ofthe personnel is based on appropriate education, training, skills and experience and is established in

line with the Food Safety and Quality Policy and Plans. All staff working in food areas is adequatelytrained in hygiene procedures.


38/84

6.2.2 Competence, Awareness and Training

a.Competence of personnel for performing the activities having Quality, Safety and Environmentimpacts has been established on the basis of appropriate education, training and or experience.

b.Enhancement of competence is done through training, education and learning involving technicalknowledge and skills, management skills and tools, social skills, knowledge of markets and

customer needs and expectations, relevant statuary and regulatory requirements, internal and

appropriate external standards, and documentation for performing the work as appropriate.

Efforts are made to increase the awareness and involvement of personnel through programs which covers:

- the vision for the future of the organization,- the Organizations policies and objectives,- organizational change and development,- The initiation and implementation of improvement activities,- introductory programs for new personnel, and- Periodic refresher programs for personnel already working with the

organization.

c. Identification of training needs- The Organization analyses the development needs of all its personnel and design training plan

for them. This is to provide personnel with knowledge which, together with skills and

experience, leads to competence.

Preparation of training plan

For identified training, training plans are prepared. The training plan covers:

-food safety training,-personnel hygiene,-hygiene and sanitation,-pest control,-Operation of equipment(Refer: Training Plan Tables in this Manual)

d.Imparting training and keeping records

- In coordination with concerned function training is imparted either by deputing persons toidentified institutions outside or by organizing in house training by engaging trainers from

outside agencies or from within the organization.


39/84

- The technical personnel have been trained on principles of ISO: 22000-2005 and are also onthe use of documentation related to the Organization's FSMS.

- Competence and training records of personnel are maintained on prescribed formats.Effectiveness of the training is assessed and records are maintained.

e. It is the responsibility of the Department Heads to identify the training needs of their personnel onthe basis of work performance, introduction of new process and technology and recommend them

for training such as external training, seminars, workshops etc. The workers have also been trained

on basic quality concepts, food hygiene and good manufacturing practices and food safety.

f. The food handlers have the necessary knowledge of food handling and preservation principles

and practices to be able to judge potential risks and take the necessary actions by effective

communications to remedy deficiencies.

g. Training Plan for Professional Skills for the Year 2011

Topics to be covered Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

GMPs facility issues, food

low, people flow, waste

low, building and

tructural issues,

egregation, cross

ontamination due to


40/84

acility issues

SOPs cleaning of all

reas/equipments/utensils

tc, personal hygiene, cross

ontamination, pest

ontrol, water safety,health issues etc

CCP related

dentification, critical

imits, monitoring,

orrective action, record

keeping, verification and

validation

Process related Non-

onformity, correctivections, internal audits,

unsafe product handling,

ontrol of documents and

ecords, traceability,

product recall and

mergency situations.

Production related

eceiving, issuing, storage,

ooking, steaming, baking,

rying, dispatch, hot/cold

holding, etc

Basic food hygiene basic

principles of handling food

Personal hygiene Hand

wash procedures, Uniform,

personal grooming, proper

use of accessories,

eporting illness and

medical health

HACCP as per Codex

SO 22000:2005 -

Awareness Training


41/84

SO 22000:2005 Internal

Auditors training

Basic Fire Safety Training

Basic First Aid Training

6.3 Infrastructure :

XYZ determines, provides and maintains the infrastructure needed to achieve conformity to productrequirements.

Infrastructure at XYZ includes :- Building, workspaces and associated utilities like UPS, generators, airconditioners, air-

compressors, etc.- Calibrated process equipment.- Supporting services like telephones, fax m/c, computers, etc.- Appropriate design and maintenance of the work area, which has a major effect on food safety.

The maintenance of the equipment complies with the Good Manufacturing Practice (GMP) andGood Laboratory Practice (GLP)

Infrastructure is maintained to ensure their suitability. Equipment maintenance is carried out as perschedule established.

6.4 Work environment


42/84

Work environment needed to achieve conformity to product requirements is provided at allworking places in the organization.

To ensure safety of personnel, activities related to safety is carried out like periodic medicalcheckup and safety awareness trainings, hygiene training programmes etc.

PLANNING AND REALIZATION OF SAFE PRODUCT

7.1 General

XYZ Plans and develops the processes needed for Product Realization. Planning of ProductRealization is consistent with the requirements of the other processes of the FSMS. The processes

are clearly defined with the measurement criteria and the interfacing with the other processes.

The results of HACCP study is taken as input to Process Planning / Food Safety Planning, with thecritical areas and shows the correct directions. The results from Food Safety Planning give anindication of the typical controls needed within a process. Food Safety Planning is linked to the

HACCP Plan in which the CCPs were identified.

To ensure Product Realization, consideration is given to associated support functions as well asdesired outputs, materials, methods, equipment, control measures, information, training needs and

other resources. Support functions include :- Training of people- Availability of infrastructure-

Application of Industrial safety / Protective Equipment

XYZ determines the following while planning for product realization:- Food Safety & Quality Objectives and requirements for the product.- The need to establish processes and documents and provide the resources specific to the

manufacturing of the food product.

- The required verification, validation, monitoring, inspection and test activities of the foodproduct and the criteria for the product acceptance.


43/84

Records needed to provide evidence that the realization processes and the resulting product meetrequirements.

In planning, the following problems / risks are considered which can occur during processing :- Risk of contamination for raw materials, additives. Work-in-progress, final products

and packaging materials

.

7.2 PRE-REQUISITE PROGRAMS

7.2.1 XYZ has made available a complete and actual description of the pre-requisite program (PRP) of

the organization. The PRPs establish

- The likelihood of introducing food safety hazards to the product through the work environment.- All classes of hazards (biological, physical and chemical) of the product/process, including cross

contamination between the products.

- The level of food safety hazards in the product and product processing environment.

7.2.2 XYZ has identified the PRPs as per the organizational needs, appropriate to the type of operationaland product manufacture along the production system. And PRPs are approved by Food Safety Team inompliance with PFA too.

7.2.3 XYZ has made available

The procedures belonging to the PRP are well established (specified and documented), fullyoperational and integrated with the ISO 22000:2005 system, and verified. Their verification is

addressed as a part of the Internal Audits and Verification activities.

XYZ has decided which food hygiene principles, good manufacturing practices and food legislationare to be included into its PRP.

7.3PRELIMINARY STEPS TO ENABLE HAZARD ANALYSIS

7.3.1 General


44/84

The products and the processes, (the procedures belonging to) and the PRP are subjected to hazardanalysis in order to identify potential hazards and to decide which way the hazards (risk) need to be

controlled. This is demonstrated in the Hazard Identification and Risk Analysis of related

products/processes, in the related HACCP/Food Safety Plans, as applicable. All the relavant

information is collected, maintained, updated and documented. Records are available for the same.

7.3.2 Food safety team

XYZ has assembled a Food Safety Team in order to develop, implement and maintain the ISO 22000System. The team definition is available in the Food Safety Team document maintained with the

FSTL. The team members have the knowledge, expertise and cover different disciplines available

which are required to develop, implement and maintain a Food Safety Management System covering

the entire scope of their operation. The competency of Food Safety Team Members is available andmaintained with the FSTL, and is reviewed & updated periodically.

The assignment (including tasks, responsibilities and authorities) are documented for the teammembers of the Food Safety Team as a part of the Responsibility and Authority document

maintained with the FSTL.

7.3.3. PRODUCT CHARACTERISTICS

7.3.3.1& 7.3.3.2 Raw materials, ingredients and product contact materials & characteristics of endproducts

The quality specifications are defined for raw materials and ingredients. The product description forvarious food groups is specified and documented. The description of the safety of the product group

encompasses the food chain, ranging from raw materials used to the distribution of the finished

products. This is further documented through the Flow Diagrams and Hazard Analysis Work Sheets

for the product group respectively

An extensive specification of the end products ensures a comprehensive assessment of the foodsafety procedures. This specification clearly defines the following product characteristics: Product identification and general product description. Raw materials used and composition. General product specifications as per recipe. Specific requirements such as appropriate legislation. General control of (chemical, microbiological and physical) for food safety. Packaging, storage conditions, labeling. Identification of potential mishandling of the product.


45/84

7.3.4. INTENDED USE

The intended use of the product is identified and documented for the product groups. Since this hasa direct influence on the required product characteristics.

The intended use of the product is continually reviewed.

7.3.5. FLOW DIAGRAMS, PROCESS STEPS AND CONTROL MEASURES

7.3.5.1 Flow diagrams

XYZ has made available a complete and actual description of the operation in the form of flowdiagrams (process steps), which are included in Food Safety Manual for the Flow Diagram, and

layouts (production facilities), which are available with the FST Leader. When applying ISO 22000

to a given operation, consideration is given to steps preceding and following the specified operation,

which is evidenced in the flow diagrams and Hazard Identification & Risk Analysis worksheet. These

descriptions are drawn up and verified by the Food Safety and Validation Teams.

The Flow Diagrams provide a schematic overview of the operation, and describe all the steps insufficient detail to provide the Food Safety Team with adequate information for the ISO 22000. Theytake into account all relevant process steps, such as the manufacturing of the product, including

critical points like:

Disinfection of vegetables before use Pre-preparation Cooking Serving

All facilities which are part of the infrastructure of XYZ, such as the production lines, storage areasand personnel facilities are depicted in layout plans. In the layout plans, the following items have

been indicated:

The routing of material, personnel. This is shown in the PLANT Layout. The areas and facilities for personnel use. This is shown in the PLANT Layout.

7.3.5.2 Description of process steps and control measures


46/84

Prior to the execution of changes in the production process and layout that could adversely affectfood safety, these changes are reported to the Food Safety Team in order to evaluate potential

hazards to food safety, and take preventive actions accordingly. Prospective changes are reported to

Food Safety Team as per the Documentation Control Procedure and its supporting documents.

The accuracy and actuality of flow diagrams and layouts are verified by the Food Safety Team forcompliance with the documented situation on a periodic basis (at least annually), in order to

identify and document modifications to the process installation and layout. Verified flow diagrams

and layouts, with changes marked on them if applicable, are maintained with the FSTL. These

periodic verifications are a part of the Internal Audit cum Verification.

7.4 HAZARD ANALYSIS

7.4.1 General

XYZ has identified, analysed and evaluated all potential (biological, chemical and physical)hazards that can have an adverse effect on the safety of the products. Wherever XYZs

operations change in a manner that could adversely affect food safety, all relevant steps of

the Hazard Identification and Risk Analysis are updated (as necessary).

7.4.2 Hazard Identification & Determination of Acceptable Level

7.4.2.1

XYZ Food Safety Team has identified and registered all potential (biological, chemical andphysical) hazards that can have an adverse effect on the safety of the products. The

identification includes all aspects of the operation within the scope of the ISO 22000 system.

Potential hazards have been documented in the Hazard Analysis Worksheet.

The operations evaluated include all products, all processes and the pre-requisite program ofthe legal owner of the products

7.4.2.2

FS Team Members shall identify and record all the potential hazards during foodpreparation, processing and delivering (biological, chemical and physical) that may have anadverse effect on the safety and hygiene of the food product.

The hazard identification includes aspects like:- Raw materials and ingredients: specifications, vendor approval, etc;- Characteristics of end products: product specifications, etc;- The Pre Requisite Program, including OPRPs- Facilities Layout, Production Lines, Installations and Equipment- Locations of rooms, routing, storage and separation of raw materials, end products, etc.


47/84

- Production processes, like: purchasing, cleaning and disinfection, packaging, maintenance, pestcontrol, waste management, etc.

- Personnel (including arrangements for visitors and external service providers, e.g.: mechanics):hygiene, knowledge with regard to food hygiene and food safety, requirement to notify diseases

and infections, etc.- Process Parameters

The identification of hazard with details of type, source, and process step and whether it isbiological, chemical or physical hazard are defined in hazard analysis worksheet. The source of

hazards (i.e, the root cause) at each processing step is subsequently taken up for analysis for

elimination of the same.

7.4.2.3 Hazard Analysis (Risk)

FS Team Members shall identify, analyze and evaluate all potential hazards(biological/microbiological, chemical/ physical) that can have adverse effect on the safety of the

food product.- The likely occurrence of hazards and severity of their adverse health effects- The qualitative and/or quantitative evaluation of the presence of hazards,- Survival or multiplication of microorganisms of concern,- Production or persistence in foods of toxins, chemicals or physical agents, and- Conditions leading to the above.

The hazard analysis process is for identifying hazards, determining the risks and control/ reductionof the risk is the risk management.

RISK MANAGEMENT PROCESS

Hazard IdentificationResp: FS Team Members

- shall list all hazards and define its characteristics

(Refer Hazard Analysis worksheets)

Hazard Analysis (Risk Assessment)

Resp: FS Team Members

- shall estimate the magnitude of the risk


48/84

Hazard analysis serves to identify the potential sources and specific points of contaminants byanalysis of each step in the food manufacturing process. Hazard analysis shall be applied at all

points from incoming material inspection to consumer.

Hazard Analysis has been conducted by the Food Safety Team based on the Flow Diagrams.Methodology followed for arriving a hazard is as follows:

- Number all steps in the flow Diagrams- Verify each step of flow Diagrams for possible physical/chemical and Biological/Microbiological

hazards

- Assess the likelihood of the hazard- Asses the consequence / severity of the incident.- Based on the above, level or risks have been evaluated. All the risks are included with the help

of group discussions by Food Safety Team and other associates from relevant areas.

- The likely occurrence of the identified hazard, evaluated quantitatively, in terms of VeryHigh, High, Medium or Low and likelihood of occurrence, as follows:

LIKELIHOOD/ PROBABILITY CONSEQUENCES/ SEVERITY RISK / LEVEL

mprobable (eg. 5- 10 years)

1 Rarely

1-4/very Low

Unlikely (eg. yearly)

2

Minor (eg. Light injuries etc.)

1

5-6/Low

Occational (eg. Monthly/4-6

Monthly)3

Medium (eg. Injuries, stomach

pain, uneasiness )2

7-9/ Medium

Likely (eg. Weekly/Monthly)

4

Major(eg. Illness, Hospitalization)

3

10-12/ High

Risk Control/Reduction

Resp: FS Team Members

- programme- control measures(Refer Hazard Analysis worksheets


49/84

Frequently (eg. Daily/ Weekly)

5

Critical (eg. Death, Permanent

disability)

4

15-20/Very High

Refer Hazard Analysis Worksheet Annexure-7.4 of this manual on following pages)

DETERMINATION OF RISK AND SEVERITY OF HAZARDS

1. Probability of occurrenceVery High > automatically happen

High > Likely to happen

Medium > could happen

Low > Not likely to happen

2. Severity of each hazard

Critical > Will frequently result in unsafe product

Major > Will likely result in unsafe product

Medium > May result in unsafe product

Minor > Will not result in unsafe product

Determination of significance

SEVERITY

PROBABIL

TY

MINOR MEDIUM MAJOR CRITICAL

LOW XXXXX XXXXX //////////////////////

///////

//////////////////////

///////

MEDIUM XXXXX XXXXX //////////////////////

///////

//////////////////////

///////

HIGH XXXXX //////////////////////

///////

//////////////////////

///////

//////////////////////

///////


50/84

VERY

HIGH

/////////

////

//////////////////////

///////

//////////////////////

///////

//////////////////////

///////

7.4.3Hazard Assessment

The severity of the hazards adverse health effects, evaluated quantitatively, in terms of critical,major or minor impact severity, as follows:

The risk rating, in quantitative terms (arrived at by multiplying the probability of occurrence withthe severity of impact), and the classification of the identified hazard into significant or non-

significant category based on the risk-rating factor. A risk rating of 10 or above indicates that the

control measure is required to control the identified hazard.

SEVERITY

PROBABILITY

MINOR

1

MEDIUM

2

MAJOR

3

CRITICAL

4

LOW

unlikely) 2

5 9 10 12

MEDIUM

occasionally) 3

7 10 12 15

HIGH

Likely) 4

9 12 15 17

VERY HIGH

Frequently) 5

12 15 17 20

An explanation / justification for the risk rating arrived at, together with the general controlmeasures in place for that risk.

A risk level of below 10 is generally considered as permissible and the routine OPRPs and PRPs aresufficient to control the hazard.

7.4.4. Selection and assessment of control measures

SIGNIFICANCE: YES: NO: XXXXX


51/84

XYZ food safety team has identified and documented the control measures that are to be applied orimplemented when the hazard identification and risk analysis exercise concludes that the risk of anidentified hazard is significant and needs to be prevented, eliminated or reduced to an acceptable

level.

For each step, including all products, all processes and all parts of the PRP, the assessed aspectshave been identified in the Hazard Analysis Worksheet and HACCP Plan. The reasons for decidingwhether or not the assessed aspect is a CCP or an Operational PRP, or a PRP have been documented,as answers to the control measure assessment matrix.

In XYZs Food Safety System, more than one control measure may be required to control a hazard,and more than one hazard may be controlled by a control measure.

The food safety team has conducted an assessment of every step of the process, and has identifiedthe significant hazards through the use of control measure assessment matrix. The assessment isbased on, amongst other things, the varied expertise within the team, and has utilized external and

internal information (as needed).

CONTROL MEASURE ASSESSMENT MATRIX

Probability of Failure of Control Measure

Very High Frequently- Daily or weekly

High Likely Weekly or Monthly

Medium Occasionally Monthly or 4-6 Monthly

Low Unlikely Yearly

Consequence in case of failure of Control Measure

Very High Definitely affects the end product

High affects end product

Medium May affect end product

Low Marginal impact on end product not affecting the food safety

Feasibility / Frequency of Monitoring

Very High Continuous


52/84

High Continuous

Medium At defined Frequency

Low Once during the process

s Control measure specifically designed

Yes More than 10

No Less than 10

If the rating of the control measure assessment exceeds 10 the process step is considered as a CCP. Ifthe rating falls between 7 10 it is considered as an Operational PRP. And the rating below 7 is

considered as PRP.

On completion of the hazard analysis, the hazards associated with each step of the food productionshall be listed along with any measures to control the hazards. More than one control measure, if

required to control a hazard, shall be identified and documented and more than hazard may becontrolled by a specific control measure.

The control measures shall be identified through the Pre-requisite Program/Operational Pre-requisite Programs. Any additional measures shall be identified during the HACCP implementationto ensure that the required control is achieved to eliminate or reduce the identified hazard / risk.

The reason for deciding a CCP shall be documented.

The level of risk shall guide the Food Safety team in identifying the level of control.

Risk Level Level of Control

15-20 Very High Avoidance/ Special Process

10-12 High Physical control / Monitoring

7-9 Medium Formal Control

5-6 Low Informal Control

1-4 Very Low Training

TRAINING: Training and teaching of the staff responsible for the process about what is to be done in order

o prevent the hazard.

NFORMAL CONTROL: Informal control is monitoring or checks of the process with out formal recording.


53/84

FORMAL CONTROL: Formal control is management of the condition of an operation to maintain the

omplaisance with documented criteria.

PHYSICAL CONTROL/ MONITORING: Continuous control and monitoring of actual physical process.

The General Control Measures relate to the control measures as part of the Pre- requisite Programand operational Pre- requisite Program, to achieve control at acceptable levels.

The general control measures shall be documented in specifications, instructions and procedures orplans

The Diagrammatic representation for control measure is Refer:

CONTROL MEASURES

Available knowledge & data

Hazard analysis

Validation

Operational

PRPs

HACCP Plan Updation

Verification

System Verification

Data & information

ACCEPTABLE PRACTICE

Prerequisite


54/84

- Recipes for the food product specifications- Operations Instruction- Procedures / plans like purchase plan, hygiene plan, cleaning and disinfection plan,

maintenance plan, education and training plan, etc..

- Pest control plan- Personnel hygiene practices

The general control measures shall be validated and shall be subsequently approved by the FoodSafety Team. The effectiveness of the general control measures shall be verified at defined intervals

through the Food Safety Audits.

Food safety team will identify critical control points and parameters for maintaining the criticalpoints in the specified i.e., PH, aW, temperature, time, pressure, which ever applicable.

The Food Safety Team has identified specific control measures that is CCPs at a step for theidentified significant hazard during hazard analysis by applying the decision tree (see Annex at

7.62 of this Manual) and also general control measures related to pre-requisite programme. Allhazards that may be reasonably expected to occur, or likely be introduced at each step, have been

considered in identifying the CCPs.. While selecting CCPs, care has been exercised that on-lineprocess related parameters which does not require elaborate and time consuming testing but

ensures products safety only have been selected.

7.5 ESTABLISHING THE OPERATIONAL REQUISITE PROGRAMMES (PRPS)

The operational PRPs have been documented as under:- Food Safety hazards- Control Measures- Monitoring Procedures- Corrective action to be taken if PRPs not in control- Responsibilities and authorities- Records of monitoring

Control measures related to control of processing environment have been classified as OperationalPRPs. These are actions or activities, often measurable in terms of physical or chemical parameters

such as temperature, time, pH, and sensory parameters such as visual appearance.

Operational PRPs based on subjective parameters, as in the case of visual inspection of a product,process, handling, etc, are supported by work instructions or specifications, education and training.

The control measures in place for each identified Operational PRPS have been documented in theHACCP Plan Worksheets. Their monitoring mechanisms, corrective actions provided, validation and

verification have also been documented in the same.

(Refer to the sections on Monitoring and Measuring, Corrective Actions, Validation, and Verification

of Hazard Analysis Worksheet included in this Manual for more details).


55/84

Control measures not related to CCPs and Operational PRPs have been classified as PrerequisiteProgrammes. In general, these measures achieve control at acceptable levels.

Prerequisite programmes are documented in the FSM Manual, specifications (including rawmaterials, products, etc), instructions (for process, control and operation) and procedures or plans,

e.g. purchase procedures, hygiene procedures (includingpersonal), maintenance schedules,cleaning and disinfection schedules, and supported by training plans, supervision, etc.

The effectiveness in controlling the identified hazards of the Prerequisite Programmes is verified atpre-defined, regular intervals, as further detailed in the section on verification in this Manual.

(Refer PRP Table 1-9 of this Manual)

HAZARD ANALYSIS WORKSHEET.No. Product

NameProcess Step Hazard Type Parameter Critical Limit

Target

value

Acceptable

level

Critical

limit

1 Non

Veg.Curry

Incoming

materialinspection at

receiving

stage.

Biological

(Possibility ofmicrobial growth)

Visual inspection - - -

External Lab

Report (Pathogenic

m.o.)

Absent Absent Absent

Washing Biological(Possibility of

microbial growth at

low level of chlorine)

Chlorine level(ppm)

15-20 20 < 15 &>20

Cleaning ofcutting tools &

Biological(Microbial flora)

Swab test forpathogenic Micro



56/84

chopping

boards

organisms

Cooking Biological

(Microbialcontamination)

Cooking Temp oC 80-100 95 100

Cooking timeminutes

60 60 < 60

Portioning Biological(Microbial flora)

Visual inspection - - -

Serving Biological

(Microbial

Contamination)

Swab test for

Pathogenic Micro

organisms


Temperature oC 50-60 55 < 50

PRE-REQUISITE PROGRAM

GOOD MANUFACTURING PRACTICES

Primary production

1.1 Environmental hygiene Not applicable

Justification: Inspection & testing of incoming stores & raw

materials by XYZ commence from receiving stage only; i.e.

receiving the items from the suppliers

1.2 Hygienic production of food sources Not applicable

Justification : Inspection & testing of incoming stores & raw

materials by XYZ commence from receiving stage only; i.e.


1.3 Handling,

Storage, and

Transport

Not applicable

Justification : Inspection & testing of incoming stores & rawmaterials by XYZ commence from receiving stage only; i.e.


1.4 Cleaning, maintenance and personal Not applicable


57/84

hygiene Justification :

Inspection & testing of incoming stores & raw materials by

XYZ commence from receiving stage only; i.e. receiving the

items from the suppliers

2 Establishment : design and facilities

2.1 Location

2.1.1 Establishments (PLANT LAYOUT) Plant located in a non polluted, environmentally clean area

Refer :Facility(Kitchen) Layout

2.1.2 Equipment / Machinery (DESIGN) Equipment maintained shall

- Permit adequate maintenance and cleaning;- Function in accordance with its intended use;- Facilitate good hygiene practices, including

monitoring.Refer :

I. Plant equipment layoutii. Cleaning Schedules

iii. Equipment Maintenance Records

2.2 Premises and rooms

2.2.1 Design and layout Process areas are clearly demarcated and separated from

each other. Where ever there is an opening / door self-closingdoors with air curtain facility provided.

Refer: Facility Layout

2.2.2 Internal structures and fittings Buildings and walls are built in such a manner that there is no

physical and chemical hazard with this.

2.2.3 Temporary / mobile premises;

vending machines

Not applicable

2.3 Equipment

2.3.1 Food control and monitoring

equipment

Thermometers, humidity meters and pressure gauges will be

provided to check the control measures.Refer :

(i) Records of calibration

(ii) Temperature measuring Records

2.3.2 Containers for waste and inedible

substances

Plastic bags of wastes are disposed off daily from the location

to distant place away from food processing area.

2.3.3 Containers for waste and inedible

substances

Containers / Disposers for waste, by-products and inedible or

hazardous substances shall be designed / constructed

2.4 Facilities

2.4.1 Water supply Water storage at different points is installed with RO and UV

System to prevent micro contamination and under strictsupervision & control.Refer:

(i) External lab reports.(ii)In house Water analysis reports

2.4.2 Drainage and waste disposal Drainage system constructed so as they always flow from the

process area to out side. Solid waste will be collected in

plastic garbage bags and moved to garbage collecting area

from there collect is done by the MCH.

Refer : Plant Layout

2.4.3 Cleaning (by cleaning detergent / Adequate facilities are provided for cleaning food utensils and


58/84

sanitizer) with surfactant equipment.

Refer :

Equipment cleaning and sanitation procedures

2.4.4 Personnel hygiene facilities and toilets Toilets, change rooms etc are provided away from theprocess block.

Toilets are provided with Hand wash facility, disinfectant

soap solution and drier (Hand).

2.4.5 Temperature control Facilities for heating, cooling or freezing food products, orstoring refrigerated or frozen foods are suitable to meet the

specified condition for ensuring food safety.

2.4.6 Air quality and ventilation Ventilation systems are designed and constructed so that air

does not flow from contaminated areas to clean areas and

they can be adequately maintained and cleaned.

2.4.7 Lighting The areas where food is being processed does not have any

window panes and also glass fixtures are properly covered to

avoid the contamination

2.4.8 Storage The processed food is packed in stainless steel vessels in hot

conditions with proper lid/ closures. The articles are then

transferred to Food Service area.

3 Control of operation

3.1 Control of food hazards FS System is being implemented

Refer :ISO:22000-2005

.2 Key aspects of hygiene control systems

3.2.1 Time and temperature control Control systems for temperature and time during heating,cooling and storage are in place where necessary for the

production and handling of safe food. Control systems include

critical limits, registration and testing of accuracy of

measuring equipment.

Refer : Temperature calibration record

3.2.2 Specific process steps Cooking is the important/ major process step which is to be

considered.

3.2.3 Microbiological and other

specifications

PFA specifications for physical and chemical parameters,

general specifications for micro organisms are being

followed.

Refer: HACCP Plan and Hazard analysis worksheet

3.2.4 Microbiological cross - contamination Cleaning and sanitation procedures are in place tp prevent

the microbiological cross contamination.

Refer:

(i) Facilities layout.

(ii) production area entering procedure

(iii) Cleaning Schedules


59/84

3.2.5 Physical and chemical contamination The material of construction for cutting trays & plastic crates

where unprocessed food is kept are made of non- particle

releasing. The crates are washed thoughly to remove any

leftover particles/ dust.

Refer :

(i) Decision tree, Hazard analysis worksheet and HACCP plan

3.3 Incoming materials requirements

3.3.1 Specifications (of Limit of

Microbiological organisms)

Supplies are XYZ approved; Raw materials are tested and

accepted as per the specifications. A well- defined program onincoming material inspection is in place. Monthly supplier

assessments in place to ensure supplier integrity.Refer :

(i) Program on incoming material

Inspection :

(ii) External laboratory analysis

3.3.2 Control at Receiving stage (of

Pathogens and Toxins)

All the raw materials and ingredients are being tested and

accepted only they are found satisfactory.

Refer : Incoming material Inspection Report

3.3.3 Stock rotation All raw materials and ingredients received are labeled with

lot numbers and a first in first out system is followed for the

rotation.

3.4 Packaging

3.4.1 Design and materials Not Applicable because packaging operation is not in the

system.

3.4.2 "Food grade" materials and gases Not Applicable because packaging operation is not in thesystem.

3.4.3 Reusable packaging Not Applicable because packaging operation is not in the

system.3.5 Water

3.5.1 Water in contact with food Water is purified with RO/ U V water purification system, and

then used in the production.

Refer : In house Water Analysis Report

3.5.2 Reuse of re-circulated, treated water Not applicable, because re-circulated water is not in use.

3.5.3 Reuse of re-circulated, non - treated

water

Not applicable, because re-circulated water is not in use.

3.5.4 As an ingredient (Potable water) Refer : In house water analysis report

3.5.5 Ice and steam In house analysis report

3.6 Management and supervision

3.6.1 Type of control and supervision Well defined organization structure is in place. Roles and

responsibilities of each and every associate are defined.Refer: Organization Chart and Roles & Responsibilities.

3.6.2 Knowledge required All the managerial and supervisory staff is trained and aware

of food safety and hygiene.

3.7 Documentation and records

3.7.1 Retain records One- year period; after which on revision further retention

will be decided.


60/84

3.7.2 Effectiveness and credibility Documents are maintained & verified regularly by

appointments at various sections of operation.

3.8 Recall procedures

3.8.1 Effective procedures A well defined Product Recall Program is in place.

Refer :SOP on Product Recall, Tracing & tracking, Destroying.

Disposal/ Reprocessing

3.8.2 Tracing and tracking Where a product has been withdrawn because of an

immediate health hazard, other products which are producedunder similar conditions, and may need to be withdrawn. The

need for public warnings shall be considered.Refer :

SOP on Product Recall, Tracing & tracking, Destroying.

Disposal/ Reprocessing

3.8.3 Destroy or reprocess Recalled products shall be held under supervision until theyare destroyed/ disposed off

Refer:

SOP on Product Recall, Tracing & tracking, Destroying.

Disposal/ Reprocessing4 Establishments: Maintenance and Sanitation

4.1 Maintenance and cleaning

4.1.1 General Equipment maintenance and cleaning procedures.

Refer:Check list on subject

4.1.2 Cleaning procedures and methods Well defined

Refer:Check list on subject

4.2 Cleaning programmes

4.2.1 Specifications Responsibility for Areas, Items of equipment, Utensils,

Containers, Method and frequency of cleaning, monitoring

arrangements etc are to be well defined4.2.2 Monitoring and verification Equipment cleaning program- frequency , area, responsibility

Refer : check list for supervisors

4.3 Pest control

4.3.1 General (i)GHP

Refer : Standing orders on subject

(ii)Effective Pest control

Refer: pest control programme.

4.3.2 Preventing access (i) No windowpanes in the production area.(ii) Proper air curtains and facilities are provided to prevent

access of pest in production area.

(iii) Security person will take care of animals not to enter.4.3.3 Harborage and infestation (i) Air tight S.S containers are provided to store the food

items.

(ii) Pest free walk in cooler & refrigerator are there forstoring food stuff & raw materials

(iii) Good house keeping practices in place.

4.3.4 Monitoring and detection Pest control activity records are available

Refer :Program on Pest Control:


61/84

4.3.5 Eradication Use of Non residual chemical Process areas excluded from use

of chemicals

Refer :

Program on Pest control;

4.4 Waste management

4.4.1 Removal, storage Waste is collected in bags and immediately shifted to garbage

area, which is being cleared by MCH every day.

4.4.2 Cleaning Cleaning is in place.

4.5 Sanitation systems

4.5.1 Monitoring Sanitation systems are in place.

Refer : Cleaning schedules;Daily check lists of KST Supervisors;

4.5.2 Verification Sanitation systems shall be periodically verified by inspectionor, where appropriate, by microbiological sampling of

environment and food contact surfaces and regularlyreviewed and adapted to reflect changed circumstances.

Remarks:Verification by monthly microbiology monitoring. In case of

changes required in procedures only division can changeafter due validation

Refer : In house lab Reports

Program on microbiological Monitoring

4.5.3 Review Sanitation system shall be regularly reviewed and adapted toreflect changed circumstances.

GOOD HYGIENE PRACTICES

5 Establishment : personal hygiene

5.1 Health status

5.1.1 Access prevention Regular Medical Check up to all the associates and Productionworkers in twice in a year basis. Onsite observation by area

supervisorsAppropriate procedures are in place

Refer :

(i) Medical reports(ii) Informatory Sign Boards at places of work

(iii) Illness & Injuries Report Register

5.2 Illness and injuries

5.2.1 Conditions to be reported Medical Examination reveals any diseases that are exist at

that time. Regular observations by area supervisors will lead

to further action required

Refer :(i) Medical reports

(ii) Informatory Sign Boards at places of work(iii) Illness & Injuries Report Register

5.3 Personal cleanliness

5.3.1 Protective clothing Protective equipment like shoes, head caps are mandatory

where ever applicable inside the Kitchen.Refer:

Program on personnel hygiene:

5.3.2 Cuts and wounds Area supervisor will act on these issues as and when arisesRefer : program on personnel hygiene:


62/84

5.3.3 Washing hands Wash facilities provided at toilets and at process area

entrance. Procedures to clean the hands were provided in

place.

Refer :

Program on good Manufacturing practices:

5.4 Personal behavior

5.4.1 Smoking, eating, sneezing Smoking , spitting, chewing & eating activities are strictly

prohibited inside the plant and process areas exceptdesignated areas

Refer :(i) Program on personnel hygiene / habits

(ii) Program on good Manufacturing practices:

5.4.2 Jewellery Personal working in the process areas are not