sample_iso_22000_manual.pdf
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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
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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.
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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 -
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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
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ABBREVIATIONS
ABBREVIATION EXPANSION
ACCT ACCOUNT
ADMN ADMINISTERATION
AMDT AMMENDMENT
AMT AMOUNT
ANNX ANNEXURE
APPX APPENDIX
ATT ATTACHMENT
BAL BALANCE
B/F BROUGHT FORWARD
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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
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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
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AMENDMENT LIST
l.
No
Document
Name
Document
Number
Date of
Amendment
Clause No. Reason for Change Authorization
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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.
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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:
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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
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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
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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
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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.
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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.
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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.
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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
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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
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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
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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
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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
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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.
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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
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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
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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
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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
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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.
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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.
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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
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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.
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- 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
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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.
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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.
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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.
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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
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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.
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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.
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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.
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- 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
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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
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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
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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.
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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
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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.
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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
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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.
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- 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
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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
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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 //////////////////////
///////
//////////////////////
///////
//////////////////////
///////
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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
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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
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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.
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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
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- 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).
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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
Absent Absent Absent
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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
Absent Absent Absent
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.
receiving the items from the suppliers
1.3 Handling,
Storage, and
Transport
Not applicable
Justification : Inspection & testing of incoming stores & rawmaterials by XYZ commence from receiving stage only; i.e.
receiving the items from the suppliers
1.4 Cleaning, maintenance and personal Not applicable
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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
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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
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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.
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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:
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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:
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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
top related