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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 be
framed
 Identifying the positions and competencies (education ,relevant experience) needed
for 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 finished
products and its storage and dispatch to be documented
 Training programs needed to the personnel as per manufacturing processes and
processing 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 the
manual. 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 standard


being implemented.
Document control

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.

SAMPLE -FOOD SAFETY


MANAGEMENT SYSTEM MANUAL
ISO 22000:2005

Prepared by:

Approved by:

Effective from:

TABLE OF CONTENTS
S. No
1
2
3
4
5
6
7

Documents
Contents
Abbreviations
Company Profile
Declaration
Distribution List
Amendment List
Recognitions/Licenses by Govt. Agencies

Document No
FSMS C
FSMS-A
FSMS C P
FSMS D
FSMS DL
FSMS AL
FSMS R

Clause No.
-

Pages

8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42

Scope of the FSMS


References
Terms and Definitions
Documentation Requirement
Control of Documents
Control of Records
Management Responsibility
Food Safety Policy
FSMS Planning
Responsibility & Authority
Food Safety Team Leader
Communication
Emergency Preparedness & Response
Management Review
Resource Management
Competence Awareness & Training
Training & Training Plan
Infrastructure & Work Environment
Planning & Realization of Safe Product
Pre- Requisite Programs
Pre. Steps to Enable Hazard Analysis
Product Characteristics
Intended Use
Flow Diagram
Hazard Analysis
Hazard Assessment
Control Measures
Operational PRPs
HACCP Plan
Updating-Verification- Traceability
Control of Non-Conforming Product
Validation, Verification & Imprv. of FSMS
Control of Monitoring and Measurement
FSMS verification
Improvement

FSMS S
FSMS R
FSMS TD
FSMS DR
FSMS CD
FSMS CR
FSMS MR
FSMS FSP
FSMS FSMSP
FSMS RA
FSMS FSTL
FSMS C
FSMS EPR
FSMS MR
FSMS RM
FSMS CAT
FSMS T&TP
FSMS IWE
FSMS PRSF
FSMS PRP
FSMS PSEHA
FSMS PC
FSMS IU
FSMS FD
FSMS HA
FSMS HA
FSMS CM
FSMS OPRP
FSMS HP
FSMS UVT
FSMS CNCP
FSMS VVIF
FSMS-CMM
FSMS-FSMSV
FSMS-I

01
02
03
4.2
4.2.2
4.2.3
5.0
5.2
5.3
5.4
5.5
5.6
5.7
5.8
6.0
6.2.2
6.2.2.3
6.3-6.4
7.0
7.2
7.3
7.3.3
7.3.4
7.3.5
7.4
7.4.3
7.4.4
7.5
7.6
7.7-7.8-7.9
7.10
8.1-8.2
8.3
8.4
8.5

ABBREVIATIONS
ABBREVIATION

EXPANSION

ACCT

ACCOUNT

ADMN

ADMINISTERATION

AMDT

AMMENDMENT

AMT

AMOUNT

ANNX

ANNEXURE

APPX

APPENDIX

ATT

ATTACHMENT

BAL

BALANCE

B/F

BROUGHT FORWARD

BIO

BIOLOGICAL

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

I/C

INCHARGE

HACCP

HAZARD ANALYSIS AND CRITICAL CONTROL POINT

HR

HUMAN RESOURCE

IDEN

IDENTIFICATION

INFRA

INFRASTUCTURE

ISO

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION

LIKELIHOOD

MAINT

MAINTENANCE

MAX

MAXIMUM

MIN

MINIMUM

OPRP

OPERATIONAL PRE-REQUISITE PROGRAMS

PHY

PHYSICAL

PRP

PRE-REQUISITE PROGRAMS

PREP

PREPERATION

P & S

PROCUREMENT & SUPPLIES

PROD

PRODUCTION

QC

QUALITY CONTROL

QMS

QUALITY MANAGEMENT SYSTEMS

QTY

QUANTITY

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

AMENDMENT LIST
Sl.
No

Document
Name

Document
Number

Date of
Amendment

Clause No.

Reason for Change

Authorization

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 - South
Indian, 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 Pizzas
and 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 hygiene
standards of the food served to our guests.

DECLARATION

XYZ Hotels brings out this Food Safety Management System Manual as part of the food safety system under
the authority of the Manager. This Manual is the original and authenticated one and the activities detailed
in 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
the MR and the details of the modifications by the food safety team leader will be indicated in the record of
Amendments.

Date:

Signed by: MR

Signature:

DISTRIBUTION LIST

The Controlled copies of the FSMS Manual are distributed to the following holders:
Controlled copy no.

Authorized Holders

01
02
03

Executive Chef
Manager QC
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

RECOGNITIONS / LICENSES BY GOVERNMENT AGENCIES

Authorization

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 meals
prepared at xyz premises .Process control plans developed and operated for all aspects that are applicable
to the safety of foodstuffs are described/ referenced in the appropriate ISO 22000 Food Safety System
documentation.
The Scope of the ISO 22000 System at xyz has been defined as per the position within the food chain, as per
process 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. ISO
22000 : 2005

Joint FAO/WHO Codex Alimentarius Commission

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, deduced
from 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 can
interact with the food safety.

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

Contaminant - Any biological or chemical agent, foreign matter, or other substances not
intentionally 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 being
met.

Control measure- Any action and activity that can be used to prevent or eliminate a food safety
hazard 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 loss
of control.

Critical Control Point (CCP) - A step at which it is essential that a specific control measure is
applied 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 number
of 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 the
control of the same management.

Flow Diagram - A systematic representation of the sequence of steps or operations used in the
preparation, processing, manufacturing, packaging, storage, transportation, distribution, handling
or offering for sale of a particular food item.

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

Food handler - Any person who directly handles packaged or unpackaged food, food equipment
and 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 food
at all stages of the food chain.

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

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

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

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 ensure
control 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 and
maintain a Food Safety Management system.

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

Hazard Analysis - The process of collecting and evaluating information on hazards and conditions
leading to their presence to decide which are significant for food safety and therefore is addressed
in the Food safety plan.

Monitoring - The act of conducting a planned sequence of observations or measurements of control


parameters to assess whether a CCP is under control.

Pre-Requisite Program (PRP)- Any specified and documented activity or facility implemented in
accordance 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 reduce
the 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 a


treatment 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 severity
of 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 within
action- 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, from
primary production to final consumption.

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

Verification - The application of methods, procedures, tests and other evaluation, in addition to
monitoring to determine compliance with the specification laid down in the HACCP Plan and the
effectiveness of the HACCP based food safety system.

Food Safety Management System Documentation Structure: The documentation structure


consists 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

4.0 FOOD SAFETY MANAGEMENT SYSTEM


4.1 General 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

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 the
scope 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 and
purview with respect to the food safety issues of the products it produces.

Proper communication (internal) throughout the organization regarding the FSMS


development, 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 basis
and/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

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 Procedures and Food Safety Manual.

4.2.2

Control of documents
Procedure for Document control is established for effective control of documents defining the
following 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 identification
to them if they are retained for any purpose.

4.2.3

The documents are updated with PRPs and HACCP plan

Control of records

Records are considered to be a special type of document, which provide objective evidence to
fulfillment 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 of
the effective operation of the Food Safety Management System. The records are maintained in such
a 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

5.0 MANAGEMENT RESPONSIBILITY


5.1 Management 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 statutory


and regulatory requirements through meetings.

5.2

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.

Food Safety Policy

XYZ has defined and documented its policy with regard to food safety, thereby demonstrating the
organizations 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 levels
of the organization. This is done through suitable means like displaying on boards and conducting
meetings, via departmental heads, etc. Employees are advised of the policy & objectives on joining
the 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
Meetings once in 6 months to ensure their continuing suitability.

Review

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 best
practices
Reflects continual improvement in the Food Safety Standards.

This commitment to Food Safety Policy will be demonstrated by the management conforming to
Food Safety Management System based on ISO 22000:2005 requirements and the following
objectives as mentioned in the table on the next page.

Electrician

Organization Chart

Managing Director

Production
Manager

Plant
Operators

Maintenance
in charge

Microbiologist

pervisor
Supervisor

Manager
Procurement

Manager QA

Supervisor

Hygiene
Supervisor

Highlighted is the HACCP team

Stores in
charge

HR
Manager

Ripening shed
in charge

Competency of each position in the organization can be documented in the below


format. 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
the people complying with this requirement.

Format for COMPETENCY MATRIX

Sl. Name of
No. Employee

Function
/
Designati
on

REQUIRED
Academic
Total
Skill
Qualification Experien set
ce

ACTUAL
Academi Total
c
Experien
Qualifica ce
tion

Skill
set

FOOD SAFETY AND QUALITY OBJECTIVES AT FUNCTIONAL LEVELS FOR THE PERIOD OF
2011-2012
S .N O

FUNCTION

OBJECTIVE

RESPONSIBILITY LEVEL
(Functional Heads)

HR

To give employees, a minimum

Manager QC

of one training program in a


month in handling, processing,
and serving of the safe food.
2

Purchase / Stores

Nonconforming input materials


not more than 5% per supplier
of the total consignment per
month

Production / Manufacturing To bring down the wastage of

Manager Stores

Executive Chef

the food to 5 % of the total


production.
4

Production / Manufacturing To monitor and maintain safe

Executive Chef

temperatures (>63C) while hot


holding of food.

Quality Assurance

Customer complaints: Not more


than 5% per month

Manager F & B

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 the
requirements of ISO 22000 standard and Food Safety/Quality Objectives.

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

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

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

On conducting a hazard analysis and Determination of the Critical Control Points (i.e., meeting the
first two HACCP principles), the HACCP Plan becomes the input for planning activities with focus on
what 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 specified
requirements and manufacturing aids

5.4 Responsibility and Authority

The Organization Chart included in this manual shows the relationships between the respective
functions.
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 the
work 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 of
management, for subsequent delegation, as appropriate.

Food Safety Team Responsibilities

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

Ensuring
that
the
HACCP
system
XYZ as per the ISO 22000:2005 standards.

Providing adequate guidance and training to all for carrying out their duties in the raw material
reception, 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 in
the XYZ

This is in addition to their existing responsibilities.

is

operating

and

maintained

in

Validation Team Responsibilities

Ensuring the adequacy, completeness, and (scientific) basis of the potential hazards identified and
analysed.
Ensuring that the aspects considered while determining the significance of hazards are evaluated
using sound scientific and technical knowledge
Ensuring that the control measures (general or specific) are appropriate and adequate to control the
hazards
Ensuring that the fluctuations of the control parameters (equivalent to process criteria) within the
defined 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

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 System
and 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.

Customer complaints and feedback are documented and Corrective and Preventive Actions are
taken accordingly.

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

5.6.2 Internal Communication

XYZ ensures that appropriate communication processes are established within the organization and
that 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 the
related 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 the
FSMS:
-

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

5.7. EMERGENCY PREPAREDNESS AND RESPONSE

Objectives of the Plan


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

emergency

Potential Emergency Situations.

Location
Raw/packing
Material
storage

Factors leading to
emergency
Electrical Fire
Bidi/Cigarette Fire

Electrical
Control
Panel Area

Flash due to short


Circuiting
Overloading and water
Spillage

Production
Area

Fire
Manual handling of
chemicals
Accidental spray of hot CIP
Solutions
Steam burns

Hazard

Preventive measures

Injury to human
Beings
Air pollution
Land Pollution
Fire
Injury to human
beings
Air Pollution

Proper connections
NO SMOKING sign is displayed.
Fire extinguishers & pipelines are
provided
Proper connections
Proper load distribution
Area to be kept dry
NO SMOKING sign is displayed.

Water Pollution
Air pollution
Injury to human
beings

Proper maintenance of pipe


Fittings
Use of safety wears etc.

Kitchen area

Fire
Leakage of LPG
Electrical sparks
Fittings & electrical short
Circuit
Lighted cigarette, match
Sticks.

Fire & explosion


Air pollution
Property damage
Injury to human
Beings.

Regular maintenance of gas


Pipe fittings.
NO SMOKING sign is
Displayed.
Fire extinguishers& Pipelines are
provided.
Monitoring of LPG

Admn.block.
Sites of high rise
Building
Painting/
Construction /
Civil work
Cleaning of
glasses

Slip or fall may lead to an


accident

Injury to human
beings

Safety belt, proper ladder,


Proper scaffolding

Slip or fall may lead to an


Accident
breakage of glass

Injury to human
beings

Safety belt, proper ladder

Potential Food Safety Emergency

Location

Factors leading
to emergency

Hazard

Production/
Kitchen Area

Bio-terrorism,
Injury to
sabotage, Bird flu Human Beings

Service center
Premises

Energy Failure

Preventive measures

Entry restricted to Production / kitchen area


Security Arrangements in the premises round the
clock.
Raw materials/commodities are accepted only
after proper checking.
Finished Product is released only after proper
checking.
Microbiology lab is in the premises; however
routine bacteriological used media / culture are
disposed off only after auto-claving.
Emergency Lights provided at the potential areas.
Accidents
Product Loss & Standby Generator/Transformer.
Timely
Delivery
effects

Service center
Premises

Flooding

Unhygienic
Conditions and
hindrances to
production.

Proper Maintenance of drainage system &


periodically cleaning.
Additional pumps provided around the premises
to throughout storm water / additional water
outside the premises.
All the premises is covered with solid brick walls
and entry gates are raised, then the road level to
stop 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 are
maintained.
For Product recall from customer please refer clause 7.10.3 (handling of potentially unsafe products)of this
manual
The Food Safety will act as an emergency team in such situations.

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 & stores
Manager 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

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 FSMS
and 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 to
control 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.

6.0

6.1

RESOURCE MANAGEMENT

Provision of Resources :

Resources (Human resources, Equipment resources and Work environment needs) required for
implementation & 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 and
continually 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 RESOURCES

6.2.1

General

XYZ provides competent personnel for performing work affecting product quality. Competency of
the 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 adequately
trained in hygiene procedures.

6.2.2

Competence, Awareness and Training

a. Competence of personnel for performing the activities having Quality, Safety and Environment
impacts 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 technical
knowledge 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
organization.

working

with

the

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 to
identified institutions outside or by organizing in house training by engaging trainers from
outside agencies or from within the organization.

- The technical personnel have been trained on principles of ISO: 22000-2005 and are also on
the 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 on
the 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
GMPs facility issues, food
flow, people flow, waste
flow, building and
structural issues,
segregation, cross
contamination due to

Jan

Feb


Mar

Apr May Jun




Jul

Aug Sep


Oct


Nov Dec


facility issues


SSOPs cleaning of all


areas/equipments/utensils
etc, personal hygiene, cross
contamination, pest
control, water safety,
health issues etc


CCP related
identification, critical
limits, monitoring,
corrective action, record
keeping, verification and
validation

Process related Nonconformity, corrective


actions, internal audits,
unsafe product handling,
control of documents and
records, traceability,
product recall and
emergency situations.

Production related
receiving, issuing, storage,
cooking, steaming, baking,
frying, 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,
reporting illness and
medical health
HACCP as per Codex
ISO 22000:2005 Awareness Training




ISO 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 product
requirements.

Infrastructure at XYZ includes :


- Building, workspaces and associated utilities like UPS, generators, airconditioners, aircompressors, 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) and
Good Laboratory Practice (GLP)

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

6.4

Work environment

Work environment needed to achieve conformity to product requirements is provided at all


working places in the organization.

To ensure safety of personnel, activities related to safety is carried out like periodic medical
checkup 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 Product
Realization 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 the
critical areas and shows the correct directions. The results from Food Safety Planning give an
indication 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 as


desired 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 food
product and the criteria for the product acceptance.

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

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
the organization. The PRPs establish

(PRP) of

- 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 operational
and product manufacture along the production system. And PRPs are approved by Food Safety Team in
compliance with PFA too.
7.2.3 XYZ has made available

The procedures belonging to the PRP are well established (specified and documented), fully
operational 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 legislation
are to be included into its PRP.

7.3 PRELIMINARY STEPS TO ENABLE HAZARD ANALYSIS


7.3.1 General

The products and the processes, (the procedures belonging to) and the PRP are subjected to hazard
analysis 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 22000
System. 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 and
maintained with the FSTL, and is reviewed & updated periodically.

The assignment (including tasks, responsibilities and authorities) are documented for the team
members 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 end
products

The quality specifications are defined for raw materials and ingredients. The product description for
various 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 food
safety 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.

7.3.4. INTENDED USE

The intended use of the product is identified and documented for the product groups. Since this has
a 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 flow
diagrams (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 in
sufficient detail to provide the Food Safety Team with adequate information for the ISO 22000. They
take 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 areas
and 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

Prior to the execution of changes in the production process and layout that could adversely affect
food 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 for
compliance 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

7.4.2.2

XYZ Food Safety Team has identified and registered all potential (biological, chemical and
physical) 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 of
the legal owner of the products

FS Team Members shall identify and record all the potential hazards during food
preparation, processing and delivering (biological, chemical and physical) that may have an
adverse 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.

- Production processes, like: purchasing, cleaning and disinfection, packaging, maintenance, pest
control, 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 is
biological, 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/ reduction
of the risk is the risk management.

RISK MANAGEMENT PROCESS


Hazard Identification
Resp: 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

Risk Control / Reduction


Resp: FS Team Members
- programme
- control measures(Refer Hazard Analysis worksheets

Hazard analysis serves to identify the potential sources and specific points of contaminants by
analysis 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 Very
High, High, Medium or Low and likelihood of occurrence, as follows:

LIKELIHOOD/ PROBABILITY

CONSEQUENCES/ SEVERITY

RISK / LEVEL

Improbable (eg. 5- 10 years)


1

1-4/very Low
Rarely

Unlikely (eg. yearly)


2

Minor (eg. Light injuries etc.)


1

5-6/Low

Occational (eg. Monthly/4-6


Monthly)
3
Likely (eg. Weekly/Monthly)
4

Medium (eg. Injuries, stomach


pain, uneasiness )
2
Major(eg. Illness, Hospitalization)
3

7-9/ Medium

10-12/ High

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 occurrence
Very 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
MINOR

MEDIUM

MAJOR

CRITICAL

PROBABIL
ITY
LOW

XXXXX

XXXXX

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

MEDIUM

XXXXX

XXXXX

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

HIGH

XXXXX

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


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

SIGNIFICANCE:

VERY
HIGH

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

XXXXX

NO:
////////////////

YES:

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


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

7.4.3 Hazard 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 with
the severity of impact), and the classification of the identified hazard into significant or nonsignificant 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
LOW
(unlikely)
2
MEDIUM
(occasionally) 3
HIGH
(Likely)
4
VERY HIGH
(Frequently) 5

MINOR
1

MEDIUM
2

MAJOR
3

CRITICAL
4

10

12

10

12

15

12

15

17

12

15

17

20

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

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

7.4.4. Selection and assessment of control measures

XYZ food safety team has identified and documented the control measures that are to be applied or
implemented when the hazard identification and risk analysis exercise concludes that the risk of an
identified 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 aspects
have been identified in the Hazard Analysis Worksheet and HACCP Plan. The reasons for deciding
whether 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 identified
the significant hazards through the use of control measure assessment matrix. The assessment is
based 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

High
Continuous
Medium
At defined Frequency
Low
Once during the process
Is 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. If
the 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 production
shall 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 be
controlled by a specific control measure.

The control measures shall be identified through the Pre-requisite Program/Operational Prerequisite Programs. Any additional measures shall be identified during the HACCP implementation
to 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
to prevent the hazard.
INFORMAL CONTROL: Informal control is monitoring or checks of the process with out formal recording.

FORMAL CONTROL: Formal control is management of the condition of an operation to maintain the
complaisance 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 Program
and operational Pre- requisite Program, to achieve control at acceptable levels.
CONTROL MEASURES

Available knowledge & data

ACCEPTABLE PRACTICE

Hazard analysis

Validation

Prerequisite

Operational
PRPs

HACCP Plan

Data & information

Updation

Verification

System Verification

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

The Diagrammatic representation for control measure is

Refer:

- 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 Food
Safety 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 critical
points 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 the
identified 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. All
hazards 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-line
process 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 Operational
PRPs. 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 the
HACCP 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).

Control measures not related to CCPs and Operational PRPs have been classified as Prerequisite
Programmes. In general, these measures achieve control at acceptable levels.
Prerequisite programmes are documented in the FSM Manual, specifications (including raw
materials, products, etc), instructions (for process, control and operation) and procedures or plans,
e.g. purchase procedures, hygiene procedures (including personal), 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 at
pre-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


S.No. Product
Name
1

Non
Veg.
Curry

Process Step

Incoming
material
inspection at
receiving
stage.
Washing

Cleaning of
cutting tools &

Hazard Type

Biological
(Possibility of
microbial growth)

Biological
(Possibility of
microbial growth at
low level of chlorine)
Biological
(Microbial flora)

Parameter
Target
value
-

Critical Limit
Acceptable
level
-

Critical
limit
-

External Lab
Report (Pathogenic
m.o.)

Absent

Absent

Absent

Chlorine level
(ppm)

15-20

20

< 15 &
>20

Swab test for


pathogenic Micro

Absent

Absent

Absent

Visual inspection

chopping
boards
Cooking

Portioning
Serving

organisms
Biological
(Microbial
contamination)
Biological
(Microbial flora)
Biological
(Microbial
Contamination)

Cooking Temp oC

80-100

95

Cooking time
minutes
Visual inspection

60

60

<80 &
>100
< 60

Swab test for


Pathogenic Micro
organisms
Temperature oC

Absent

Absent

Absent

50-60

55

< 50

PRE-REQUISITE PROGRAM

GOOD MANUFACTURING PRACTICES


I
Primary production
1.1
Environmental hygiene

1.2

Hygienic production of food sources

1.3

Handling,
Storage, and
Transport

1.4

Cleaning, maintenance and personal

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
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
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
Not applicable

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)
2.1.2

Equipment / Machinery (DESIGN)

2.2
Premises and rooms
2.2.1
Design and layout

2.2.2

Internal structures and fittings

2.2.3

Temporary / mobile premises;


vending machines
2.3
Equipment
2.3.1
Food control and monitoring
equipment

2.3.2
2.3.3

Containers for waste and inedible


substances
Containers for waste and inedible
substances

2.4
Facilities
2.4.1
Water supply

2.4.2

Drainage and waste disposal

2.4.3

Cleaning (by cleaning detergent /

Plant located in a non polluted, environmentally clean area


Refer :Facility(Kitchen) Layout
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 layout
ii. Cleaning Schedules
iii. Equipment Maintenance Records
Process areas are clearly demarcated and separated from
each other. Where ever there is an opening / door self-closing
doors with air curtain facility provided.
Refer: Facility Layout
Buildings and walls are built in such a manner that there is no
physical and chemical hazard with this.
Not applicable

Thermometers, humidity meters and pressure gauges will be


provided to check the control measures.
Refer :
(i) Records of calibration
(ii) Temperature measuring Records
Plastic bags of wastes are disposed off daily from the location
to distant place away from food processing area.
Containers / Disposers for waste, by-products and inedible or
hazardous substances shall be designed / constructed

Water storage at different points is installed with RO and UV


System to prevent micro contamination and under strict
supervision & control.
Refer:
(i) External lab reports.
(ii) In house Water analysis reports
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
Adequate facilities are provided for cleaning food utensils and

sanitizer) with surfactant

equipment.
Refer :
Equipment cleaning and sanitation procedures
Toilets, change rooms etc are provided away from the
process block.
Toilets are provided with Hand wash facility, disinfectant
soap solution and drier (Hand).
Facilities for heating, cooling or freezing food products, or
storing refrigerated or frozen foods are suitable to meet the
specified condition for ensuring food safety.

2.4.4

Personnel hygiene facilities and toilets

2.4.5

Temperature control

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
3.1

Control of operation
Control of food hazards

3.2
Key aspects of hygiene control systems
3.2.1
Time and temperature control

3.2.2

Specific process steps

3.2.3

Microbiological and other


specifications

3.2.4

Microbiological cross - contamination

FS System is being implemented


Refer :
ISO:22000-2005

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
Cooking is the important/ major process step which is to be
considered.
PFA specifications for physical and chemical parameters,
general specifications for micro organisms are being
followed.
Refer: HACCP Plan and Hazard analysis worksheet
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

3.2.5

Physical and chemical contamination

3.3
Incoming materials requirements
3.3.1
Specifications (of Limit of
Microbiological organisms)

3.3.2

Control at Receiving stage (of


Pathogens and Toxins)

3.3.3

Stock rotation

3.4
Packaging
3.4.1
Design and materials
3.4.2

"Food grade" materials and gases

3.4.3

Reusable packaging

3.5
Water
3.5.1
Water in contact with food

3.5.2

Reuse of re-circulated, treated water

3.5.3

Reuse of re-circulated, non - treated


water
As an ingredient (Potable water)

3.5.4

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

Supplies are XYZ approved; Raw materials are tested and


accepted as per the specifications. A well- defined program on
incoming 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
All the raw materials and ingredients are being tested and
accepted only they are found satisfactory.
Refer : Incoming material Inspection Report
All raw materials and ingredients received are labeled with
lot numbers and a first in first out system is followed for the
rotation.

Not Applicable because packaging operation is not in the


system.
Not Applicable because packaging operation is not in the
system.
Not Applicable because packaging operation is not in the
system.
Water is purified with RO/ U V water purification system, and
then used in the production.
Refer : In house Water Analysis Report
Not applicable, because re-circulated water is not in use.
Not applicable, because re-circulated water is not in use.
Refer : In house water analysis report

3.5.5
Ice and steam
3.6
Management and supervision
3.6.1
Type of control and supervision

In house analysis report

3.6.2

All the managerial and supervisory staff is trained and aware


of food safety and hygiene.

Knowledge required

3.7
Documentation and records
3.7.1
Retain records

Well defined organization structure is in place. Roles and


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

One- year period; after which on revision further retention


will be decided.

3.7.2

Effectiveness and credibility

3.8
Recall procedures
3.8.1
Effective procedures

3.8.2

Tracing and tracking

3.8.3

Destroy or reprocess

Documents are maintained & verified regularly by


appointments at various sections of operation.
A well defined Product Recall Program is in place.
Refer :
SOP on Product Recall, Tracing & tracking, Destroying.
Disposal/ Reprocessing
Where a product has been withdrawn because of an
immediate health hazard, other products which are produced
under 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
Recalled products shall be held under supervision until they
are destroyed/ disposed off
Refer:
SOP on Product Recall, Tracing & tracking, Destroying.
Disposal/ Reprocessing

4
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 defined
4.2.2
Monitoring and verification
Equipment cleaning program- frequency , area, responsibility
Refer : check list for supervisors
4.3
Pest control
4.3.1
General

4.3.2

Preventing access

4.3.3

Harborage and infestation

4.3.4

Monitoring and detection

(i)GHP
Refer : Standing orders on subject
(ii)Effective Pest control
Refer: pest control programme.
(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.
(i) Air tight S.S containers are provided to store the food
items.
(ii) Pest free walk in cooler & refrigerator are there for
storing food stuff & raw materials
(iii) Good house keeping practices in place.
Pest control activity records are available
Refer :
Program on Pest Control:

4.3.5

Eradication

4.4
Waste management
4.4.1
Removal, storage
4.4.2
Cleaning
4.5
Sanitation systems
4.5.1
Monitoring

4.5.2

Verification

4.5.3

Review

GOOD HYGIENE PRACTICES


5
Establishment : personal hygiene
5.1
Health status
5.1.1
Access prevention

5.2
Illness and injuries
5.2.1
Conditions to be reported

5.3
Personal cleanliness
5.3.1
Protective clothing

5.3.2

Cuts and wounds

Use of Non residual chemical Process areas excluded from use


of chemicals
Refer :
Program on Pest control;
Waste is collected in bags and immediately shifted to garbage
area, which is being cleared by MCH every day.
Cleaning is in place.
Sanitation systems are in place.
Refer : Cleaning schedules;
Daily check lists of KST Supervisors;
Sanitation systems shall be periodically verified by inspection
or, where appropriate, by microbiological sampling of
environment and food contact surfaces and regularly
reviewed and adapted to reflect changed circumstances.
Remarks:
Verification by monthly microbiology monitoring. In case of
changes required in procedures only division can change
after due validation
Refer : In house lab Reports
Program on microbiological Monitoring
Sanitation system shall be regularly reviewed and adapted to
reflect changed circumstances.

Regular Medical Check up to all the associates and Production


workers in twice in a year basis. Onsite observation by area
supervisors
Appropriate procedures are in place
Refer :
(i) Medical reports
(ii) Informatory Sign Boards at places of work
(iii) Illness & Injuries Report Register
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
Protective equipment like shoes, head caps are mandatory
where ever applicable inside the Kitchen.
Refer:
Program on personnel hygiene:
Area supervisor will act on these issues as and when arises
Refer : program on personnel hygiene:

5.3.3

Washing hands

5.4
Personal behavior
5.4.1
Smoking, eating, sneezing

5.4.2

Jewellery

5.5
5.5.1

Visitors
Cleanliness and behavior

6.0
6.1

Transportation
General

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:
Smoking , spitting, chewing & eating activities are strictly
prohibited inside the plant and process areas except
designated areas
Refer :
(i) Program on personnel hygiene / habits
(ii) Program on good Manufacturing practices:
Personal working in the process areas are not allowed to
wear loose jewellery
Refer:
Program on personnel hygiene / habits
Visitors wear caps; sanitize hands and then only lead to the
production area.
Refer:
Visitors policy procedures
Closed SS containers are being used during food Serving &
Food Dispatch/Serving.

6.2

Requirements

Where necessary, conveyances and bulk containers shall be


designed and constructed so that they :
- do not contaminate foods
- can be effectively cleaned and, where necessary, disinfected;
- permit effective separation of different foods or foods from
non- food items where necessary during transport
(Dispatch/Serving)
- provide effective protection from contamination, including
dust and fumes ;
- can effectively maintain the temperature, humidity,
atmosphere and other conditions necessary to protect food
from harmful or undesirable microbial growth and
deterioration likely to render it unsuitable for consumption;
- allow any necessary temperatures, humidity and other
conditions to be checked.

6.3

Use and maintenance

Regular cleaning of food carrying SS containers is being done.

7
7.1
7.2
7.3
7.4

Product information and consumer awareness


Batch identification
Not applicable
Product information
Not applicable
Labeling
Not applicable
Consumer education
Being done as on need basis.

8
8.1

Training
Awareness and responsibilities

Associates are trained on food safety and their roles and


responsibilities in handling food products to prevent any
contamination or deterioration.

8.2

Training programs

8.3

Instruction and supervision

8.4

Refresher training

Training on Food Safety to all associates is being conducted.


Refer :
Program on Training:
The training on FSMS includes all the requirements
Refer :
Program on Training
A well defined training program is in place and the
effectiveness of the training is being assessed periodically.
Supervisory and Managerial level Staff is aware of FSMS.
Refer :
Program on Training:
Training programs shall be routinely reviewed and updated
where necessary.
Systems shall be in place to ensure that food handlers remain
aware of all procedures necessary to maintain the safety and
suitability of food.
Remarks:Based on the skill Gap Analysis the associates are evaluated.
Based on the Skill Matrix, the associates being provided with
a required awareness/ refreshers training.

HACCP PLAN:
S Product
.
Name
N
o
1 Chicken
biryani

Step

cooking

Hazard

Micro
biological
; survival
of
pathogeni
c Microorganism
s

Critical limit
Parameter Value

Cooking
time,
cooking
temp

Min 1
hr,
80 1000c

Procedu
re
Checking
cooking
time
with
stop
watch,
and
tempera
ture
with
digital
thermo

Monitoring
Freque
Resp
ncy
As and
when
cooked
as per
menu

chef

Record

Refer:
Time
and
Temp
of food
items

Corrective action
Procedure
Record

i)if found
undercooke
d increase
the cooking
time
ii)if found
over
cooked
discard the
item

Time &
Temp
record

meter(S
S Probe)

Plain
rice

Cleaning
of rice

Physical:
presence
of foreign
particles

Extraneou
s matter/
foreign
particles

7.6.

i)inspect
ion of
stock
arrived
ii)superv
ising
rice
cleaning

As and
when
done

store man

Refer:
Raw
material
data
sheet

i)Get the
rice
cleaning
redone
ii)Return to
supplier if
foreign
matter is
more

ESTABLISHMENT OF HACCP PLAN

7.6.1 HACCP Plan

The HACCP plan is documented for each CCP which includes food safety hazard critical limit
monitoring procedure and corrective actions required with responsibilities and authorities.
Refer HACCP Plan

7.6.2 Identification of CCP

For each food hazard that is to be controlled by HACCP plan CCPs are determined by CCP decision
tree. The CCP decision includes
1. Do preventive measure exist?

i.Reject
on
record
ii.Vendo
r,
compla
nts
record

2. Is the step specially designed to eliminate/reduce the likely occurrence of an acceptable level?
3. Could contamination with identified hazard(s) occur in acces acceptable level(s) or could

increase to an unacceptable?
4. Will a subsequent step eliminate identified hazard (s) or reduce likely appearance to an
acceptable level?
(Refer: CCP-Decision Tree as Annex 7.6.2 of this Manual on next page)

EXAMPLE OF DECISION TREE TO IDENTIFY CCPS

CCP DECISION WORKSHEET:

S.No

Step

CCP Decision(yes/ No)

Procurement
Perishable items

Physical
Chemical
Biological

Yes
Yes
Yes

2
Is the step specially
designed to
eliminate/reduce
the likely
occurrence of an
acceptable level?
Yes
Yes
Yes

Non- perishable
items.

Physical

Yes

Yes

No

No

Chemical

Yes

Yes

No

No

Biological
Physical

Yes
Yes

Yes
Yes

No
No

No
No

Chemical

Yes

Yes

No

No

Biological

Yes

Yes

No

No

Physical
Chemical
Biological

Yes
Yes
Yes

Yes
Yes
Yes

No
No
No

No
No
No

Storage a)
Storage of
perishable items
freezer, walk in
cooler
b) Storage of nonperishable items in
dry storage area.

6.3

Type of
Hazard

1
Do
preventi
ve
measure
exist?

3
Could contamination
with identified
hazard(s) occur in
acceptable level(s) or
could increase to an
unacceptable?
No
No
No

4
Will a subsequent
step eliminate
identified hazard (s
or reduce likely
appearance to an
acceptable level?
No
No
No

Determination of critical limits for critical control points

XYZ has defined the critical limit(s), which must be met at all times during the operation for the
various parameters. Also, normal operational target values have been indicated are the various
parameters, as well as the action limit values which indicate when intervention in the operation is
required in order to continuously meet the critical limits.

The critical limit(s), action limit(s) and target value for each parameter have been documented in
the OPRP & HACCP Plan associated with each CCP and or Operational PRP.

When determining the critical limits and the deduced action limits and target value, the
requirements of the relevant legislation and regulations and/or internal risk analysis for the safety
of foodstuffs has been considered as requirements. These have been identified / referenced in the
HACCP Plan associated with each CCP.
(Refer: HACCP Plan tables)

7.6.4 SYSTEM FOR THE MONITORING OF CCPs


Monitoring is the scheduled measurement or observation of a CCP relative to its critical limit.
Monitoring details has been elaborated below, through which answer for following four questions
are obtained:
- What is being monitored? (say temperature)
- How the monitoring is done? (say digital thermometer with SS probe,
recording thermometer, digital time/temperature data logger or similar device and visual
check on time)

- How often the monitoring is being done (frequency)? (in case of digital recording- continuous
monitoring, with visual check at least once in cycle/batch but not less than once per day, in
case of other type of device- visual check at least once in cycle/batch but not less than once
per day)
- Who is doing monitoring? (Ex. Chef/Chef/Manager QC /Manager Store)

Measurement/ observation for each product and for each CCP has been identified and indicated in
HACCP plan. Records associated with the monitoring have been indicated in relevant Column.

The Monitoring Devices shall be identified though the list of Monitoring Devices, The methodology
for calibrating the monitoring devices shall be calibrated
(Refer Records of calibration of Monitoring Devices)

The results of monitoring process parameters (with the calibrated instruments shall be recorded)

7.6.5 ACTIONS WHEN MONITORING RESULTS EXCEEDS CRITICAL LIMITS

For the identified CCPs, it is ensure that Corrective Actions are initiated and implemented in case
action limit value or a critical value is exceeded the cause of the deviations shall be analyzed and
documented with the justification for the corrective action initiated and responsibilities and
authorities of the personnel involved

The corrective action may include:


- With respect to the product- temporary hold of the product/batch, blockades to product
recall, identification of nonconforming product, rework, disposal/ destruction of
product/batch.
- With respect to process- adjusting the process, adjustment/ correction of process conditions.

Specific corrective actions have been established for each CCP in order to deal with deviations
when they may occur. The actions taken ensure that the CCP has been brought under control.
(Refer: HACCP Plan tables)

7.7

UPDATING OF THE PRELIMINARY INFORMATION AND DOCUMENTS SPECIFYING THE PRPS


AND HACCP PLAN)

The organization has updated the following information:


Product characteristic
Intended use
Flow diagram
Process steps
Control measures

Prior to application of HACCP, it has been ensured that:

- The general principles of Food Hygiene as per Codex Standard for the food sector referred in the
scope are in place. An audit checklist based on Codex Standard prepared to conform to food
hygiene, personnel hygiene and good manufacturing practices for the applicable food sector.
- The compliance of which is being ensured during internal audit by the assigned auditor.
Note-Like the products and the process, the PRP is subjected to the hazard analysis in order to identify
potential hazards and to decide in which way the hazards (risk) need to be controlled.

Food Safety Legislation [Prevention of Food Adulteration Act] is implemented.

The FS Team Members have been trained on the steps, principles and application of HACCP and
Food Hygiene. Training has also been provided to personnel at various levels on principles of
maintaining cleanliness and hygiene and this is an on-going activity. As an aid in developing specific
training, work instruction and procedures have been prepared.

XYZs Food Safety team updates the information of the PRP, Operational PRPs and HACCP Plan
whenever new products are introduced or any new equipment are installed or any change of
control measures or process flow or any change in intended use would be required

7.8. VERIFICATION PLANNING

The main function of verification is to determine compliance with the specification of the FS System
and to confirm that the FS System is working effectively through the application of auditing,
procedures and tests including random sampling and analysis. The frequency of verification activity
which inter-alia include the following should be sufficient to confirm that the FS System is working
effectively:
- review of the FS System and its records,
- review of non-conformities and product disposition, and
- Confirmation that CCPs are kept under control.

Verification of CCP Monitoring - In-charge quality assurance reviews the performance of CCP
operation with respect to the following:

- Critical Control Limits- This review is to ensure that the records are complete and to verify that
the documented values are within the critical limits. This review is done at regular intervals, for
each product and is submitted on prescribed format. This report is reviewed by FS Team Leader.
- Conducting Test/Analysis- This is to verify that the results of test or analysis corroborate the
purpose or intent of the CCPs. This verification is done at regular intervals specified in for each
product and records maintained.
VERIFICATION LOG FOR CRITICAL CONTROL POINTS
Date/Time

Product

CCP No.

Observation/measurements

Comments

Signature

On Going Verification to Show Compliance with Plan


FS Team reviews the performance of operation of FS System on quarterly basis. This review
includes verification of following records to ensure that FS System is in place and working
satisfactorily:
- Monitoring activities have been performed at the locations specified in the HACCP plan
- Monitoring activities have been performed at the frequencies specified in the HACCP plan
- Corrective actions have been taken whenever monitoring indicated deviation from critical
limits and also taking into consideration internal and external audit results
- Equipment has been calibrated at the frequencies specified in the in quality system
procedures
- Confirmation that CCPs are kept under control.
- Review of Consumer Complaints that have relevance to the performance of FS System
- Review of Sanitation Records and GMP
- Review of the result of periodic in-process and final product testing.

Comprehensive Food Safety System Verification (Reassessment)

This verification answers the questions, whether Food Safety plan is controlling hazards? and is the
Food Safety Plan still controlling hazards? It is a thorough review of hazard analysis to address
specific hazards to determine if they are controlled. A reassessment of the adequacy of the plan is
done on any changes that could affect the hazard analysis or alter the plan in any way such as raw
materials, source of raw materials, product formulation, processing methods or system, intended
use or consumers of the product, product distribution system etc, or at least annually.

Audits

In addition, internal audits (Refer: FSMS Manual Doc.No.XYZ./FSMSV-8.4.1) and external audits also
provide feed back on effective implementation of the system and provide evidence for verification.

Documentation and Records

The Food Safety Team has established an efficient documentation and record keeping the relevant
FS System Procedures have been maintained separately. Records are kept from all areas, which
are critical to product safety to demonstrate that the Food Safety system is in compliance with the
documented system, some of them are indicated below:

Food Safety Team Meeting records





















Non conforming product record,


Traceability record,
CCP Monitoring Records,
CCP verification records,
Corrective Action records if any,
Hygiene Audit record
Control Measures Record (Time & temp)
Agenda & minutes of Management Review
Training & Evaluation of Training records,
Audit records,
Record of Daily check lists
Water Analysis record
Pest Control records
Preventive Maintenance record
Cleaning schedules
Staff medical reports,
In house lab analysis reports,
Record of Calibration of measuring and testing equipments

7.9

Traceability system

The product identification and traceability is required because of one or more of the following
reasons:
Status of the food products at all stages of manufacturing
Contractual requirement, wherein the food product is marked by a specific mark or
code for subsequent verification by the customer
Intended use of application

Food product identification starts with the receipt of the raw materials / ingredients and ends with
the delivery and serving of the food product, clearing of the used crockery, housekeeping of the
place and disposal of the left-over food. The identification and traceability helps in effective stock
rotation and ensures product recall, if called for.

The organization has established a traceability system that enables the identification of product lots and
their relation to raw material, processing and delivery record for identifying incoming material for the
immediate suppliers. Traceability record shall be maintained for a definite period for system assessment
to enable the handling of potentially unsafe product. Record shall be in accordance with the statutory and
regulatory requirements

7.10 CONTROL OF NON-CONFORMING PRODUCT

Products not conforming to the requirements are identified and prevented from unintended use or
delivery.

Control exercised along with the defined responsibility for handling the non-conforming product is
described in procedure for Non Conforming product.

7.10.1 Corrections
The following methods are employed if any non-conformity is detected
- Action to eliminate the detected non conformities
- Authorize its use, release under concession by relevant authority
- Preclude its original use.

Records of nonconformities subsequent corrective actions taken are maintained.

7.10.2 Corrective action

It includes:
- Necessary corrective actions are taken up by the respective chefs to prevent recurrence of
nonconformities noticed.
- Corrective actions are carried out as per procedure for corrective and preventive action which
includes:
-

Reviewing non-conformities, including customer complaints


Determining the causes of nonconformities
Evaluating the need for action to ensure that nonconformities do not re occur
Determining and implementing action needed
Records of the results of action taken
Reviewing corrective action taken

For each critical control point, in the associated OPRP & HACCP Plan, XYZ has documented (or
referenced) the corrective actions to be taken if an action limit value or critical limit is exceeded.
The procedure includes the process to investigate the cause of the deviation.

The Food Safety Team is considered as Emergency Team for responding to critical limit
deviations. The team evaluates the causes of deviation and decides which additional preventive
actions are to be taken.

7.10.3 Handling of potentially unsafe products

7.10.3.1

General

7.10.3.2

XYZ has also established arrangements that provide for recall of the products from the
market place and/or from end consumers. Proper product identification and a tracing and
tracking system are operational. These are detailed in the Handling of Potentially Unsafe
Products Procedure.
Evaluation for release

7.10.3.3

All corrective actions taken, the causes and consequences, and the individuals involved in the
corrective action are recorded. The effectiveness of the corrective action (for both process
and product) is evaluated.
Disposition of non conforming product
Any product resulting from the process while the critical limit has been exceeded is treated
as non -conforming product. The corrective actions with respect to product might include:
Actions ranging from raw material to product / batch / lot recall.
Identification of the non-conforming products / batches / lots.
Disposal / destruction of the product / batch / lot.

7.10.3.4

Withdrawals

XYZ has established a procedure for withdrawal of end product which have been identified
as unsafe
The withdrawal activity in XYZ is initiated by FST Leader.

8 VALIDATIONS, VERIFICATION & IMPROVEMENT OF THE FOOD SAFETY MANAGEMENT SYSTEM


8.1

General
Validation is done to ensure that the hazards originally identified are complete and correct and that
the hazards are effectively controlled

Necessary validations of control measures are planned and implemented to:


-

Demonstrate conformity of the product to the specified requirements


Ensure conformity to Food Safety Management System
Continually improve effectiveness of Food Safety Management System

Food Safety Team shall plan and implement the processes needed to validate control measures,
combinations and verify and improve the system.

8.2

Validation of The Control Measures Combinations

Validation is activity prior to authorizing HACCP Plan. For this, organization has constituted a
Validation team comprising of following:

It is the responsibility of the validation team to review that effectiveness after supporting evidence
used in the HACCP study i.e., control measures, monitoring system for PRP , OPRP and CCP &
corrective actions taken for any deviations
a) Initial Validation

The HACCP Plan prepared by the FS Team has been validated for its adequacy and completeness by
the validation team. Validation has been performed on the basis of the quantifiable and objective
historical results from on-line quality control monitoring, end product testing, and customer
complaints and by demonstrating that:
- the established list of potential hazards is based on sound scientific data and has
included all
hazards,
- questions used to assess the significance are answered using sound scientific and technical
knowledge,
- the control measures(general and specific) are appropriate to control the hazards,
- fluctuations of the control parameters(equivalent to process criterion) within the defined critical
limits will not affect the safety of the product,
- parameters and methods used to monitor the control measures are appropriate,
- corrective actions are appropriate and will prevent the release of unsafe products and provide
evidence that the situation can be corrected immediately

Note- Food business operators produced safe food for many years before the introduction of the HACCP
system. Therefore, historical results from on-line Quality Control monitoring, end product testing,
customer or consumer complaints are used as evidence when validating HACCP plans. It is important to
note that the data must be quantifiable and objective if it is to be useful.
b) On going validation

Critical Control limits are validated once in a quarter to confirm whether they are still valid. If not
providing the degree of confidence envisaged, new limits are established. The FS system is also
validated by the team whenever:
CCP,s are changed/modified,
Process changes takes place affecting food safety,
Equipment changes/replacement occur affecting food safety,
Major system failures occur

Validation of the CCP

REMARKS IF ANY

VERIFICATION STATUS

COMPLAINT IF ANY

CALIBRATION STATUS

MAINTENANCE STATUS

TEST STATUS

CORECTIVE ACTION IF ANY

MONITORING RECRD

MONTH & YEAR OF REVIEW

CCP OBJECTIVE

CRITICAL LIMIT

CCP

CCP NO

PRODUCT

8. VALIDATIONS, VERIFICATION AND IMPROVEMENT OF FSMS


8.1 General

Necessary validations of control measures are planned and implemented to:


- Demonstrate conformity of the product to the specified requirements
- Ensure conformity to Food Safety Management System
- Continually improve effectiveness of Food Safety Management System

8.2

Validation of control measure combinations

The objective of validation is to ensure that the hazards originally identified by the Food Safety
Team are complete and correct and that they will be effectively controlled under the proposed plan.

To meet the objectives of validation, the effectiveness of the supporting evidence used in the HACCP
study as well as the general and specific control measures, the monitoring system and the corrective
actions have been reviewed.

Each time XYZ operation changes in a manner that could adversely affect food safety the
corresponding OPRP & HACCP Plan/s is/are updated.
Validation is performed by the Validation Teams independent review of the following:

The established list of potential hazards is based on sound scientific data and has included all
hazards.
The questions used to assess the significance are answered using sound scientific and technical
knowledge.
The control measures (OPRPs & CCPs) are appropriate to control the hazards, i.e. to prevent
or eliminate, to reduce or maintain at an acceptable level
Fluctuations between target values and action limits will not affect the safety of the product.
The parameters and methods used to monitor the control measures are appropriate

XYZ have produced safe food in their earlier assignments. Therefore, historical results from on-line
quality control monitoring, end product testing, and customer or consumer complaints have been
used as evidence when validating OPRP & HACCP Plans.

8.3 CONTROL OF MONITORING AND MEASURING

XYZ demonstrates the :


- Conformity of the food product
- Conformity of FSMS
- Continual Improvement of the effectiveness of the FSMS

XYZ has established and maintained a monitoring (and/or measuring, as appropriate) system for
effective and efficient control of the Critical Control Points.
The monitoring and measuring system is defined in the OPRP & HACCP Plan associated with each
CCP, and includes all planned measurements, observations and analysis of the control parameters
determining that the CCP is under control.

The Plan associated with each CCP documents (or references) the following aspects:
The development of the monitoring system.
The identification of monitoring (measuring) devices.
The methodology of measurement and/or the instructions for measuring and recording of
measurements.

The method for establishing the reliability of the measurements and/or the equipment (calibration).

Where measurements and product tests by subcontractors are used as a means of monitoring /
measuring, these are generally done from recognized laboratories.

The results of the monitoring are documented by means of records (as indicated in the Plan) and the
practices are described in process control plans (as referenced in the Plan).

The records include:


Monitoring Reports (dated and signed)
Records of Deviations which have occurred (action limits and critical limits) and corrective
actions taken are available.

8.4. FSMS VERIFICATION

XYZ has established and implemented procedures for the verification of the Food Safety
Management System. The main purpose of verification is to determine compliance with the
specifications of the Food Safety Management System and to confirm that the system based on ISO
22000:2005 standard is working effectively through the application of (auditing) methods,
procedures, tests (including random sampling and analysis) and other evaluation, in addition to
monitoring.

8.4.1 Internal audit:

Internal audits are conducted based on the schedule drawn up to determine whether the Food
Safety Management System
-

Conforms to the planned arrangements for meeting the product realization, ISO
22000:2005 and Food Safety Management System requirements.

Is effectively implemented and maintained

XYZ has defined an internal audit program, taking into consideration the status and importance of
the processes and areas to be audited, as well as the results of previous audits. The audit criteria,
scope, frequency and methods are defined generally in the Internal Food Safety Audits

Selection of auditors and the conduct of audits are done in such a way as to ensure objectivity and
impartiality of the audit process. Auditors do not audit their own work.

8.4.1.2

Internal Audits are planned taking into consideration the importance of the processes and

activity being audited and results of the previous audits.


8.4.1.3

Scope, audit criteria, frequency and methods of auditing are defined in procedure for internal

food safety audits.

This procedure also identifies the responsibility and requirements for planning and

8.4.1.4

conducting audits, for reporting the results and maintaining the records.
8.4.1.5

Trained personnel to ensure objectivity and impartiality conduct internal audits.

8.4.1.6

The personnel responsible for the area audited identify and implement the necessary

corrective actions to eliminate the recurrence of the reported nonconformance. The corrective
actions taken up by the auditee are verified and the verification is recorded.
XYZ determines whether the FSMS:

8.4.2

Conforms with the planned arrangements:


With the Requirements for an ISO 22000-based Food Safety System and
With the requirements established by XYZ itself, and reflected in the current food safety
system.
Is effectively implemented and maintained.

Verification aspects are covered under the Internal Food Safety Audits. The Internal Audit
Procedure describes the internal audit and verification methodologies which are carried out as per
the Verification plan at XYZ, together with the responsibilities and requirements for planning and
conducting audits, for reporting results and maintaining records.
Evaluation of individual verification results.
Each department compiles data to demonstrate the suitability and effectiveness of Food Safety
Management System and identifies improvements for effectiveness of Food Safety Management
System in respect of operation of each department.

The data includes information generated through measurements and monitoring and other relevant
sources. This includes monitoring and review of the objectives at the department level and also
includes
a. Existing procedures and communication channels
b. HACCP plan , OPRPs and hazard analysis conclusions
c. The PRPs
d. The training plan and training effectiveness of food handlers

8.4.3 Analysis of results of verification activities

The analysis of data by Food safety team including internal and external audits provides
information relating to
- Customer satisfaction
- Product conformity
- Characteristics and trends of processes and products including opportunity for preventive
action
- Suppliers

The analysis is carried out


a. To confirm overall performance of FSMS as per the established requirements by the
organization
b. To update or improve the FSMS
c. To identify trends with a higher degree of incidence for potentially unsafe products
d. To upgrade and plan internal audit program as per the status and importance of FSMS
e. To provide evidence for any corrective action as per FSMS that have been taken are effective

The results of analysis and the resulting activities are recorded

Record are maintained

8.5 IMPROVEMENT

8.5.1

Continual Improvement:

Based on the analysis of data and results of audit, areas needing improvement are identified to initiate
necessary corrective and preventive actions.

Where appropriate, the relevant Food Safety Objectives and Food Safety Policy are revised and
reviewed in meetings to focus on improvement

XYZ continually improves the effectiveness of the Food Safety Management Systems through the
use of :
-

8.5.2

Evaluation of individual verification results


Validation of control measure combination
Food Safety Policy
Food Safety Objectives
Internal Audits
Analysis of Data
Corrective Actions
Preventive Actions
Management Reviews
FSMS Updating

UPDATING OF FSMS

XYZ ensures that FSMS is continuously updated by evaluation and updating activities like
a. Inputs from communication, information with reference to FSMS
b. Input from information concerning the suitability, adequacy and effectiveness of the
FSMS and Statutory and regulatory bodies
c. Outputs from verification activities and management review.
d. Output from management review meetings

Records of these activities are reported as an input to the management review.