ISO 22000:2005-

UNIT 9 ISO 22000:2005 - STRUCTURE Structure

Structure
9.0 Objectives
9.1 Introduction
9.2 Economic Loss due to Food Borne Illness
9.3 ISO 22000: 2005 Clauses
9.4 FSMS Documentation Structure
9.4.1 Food Safety Manual
9.4.2 Mandatory Procedures
9.4.3 Standard Operating Procedures (SOP)/ Work Instructions
9.4.4 HACCP Pre-steps Related Documents
9.4.5 HACCP Principles Related Documents
9.4.6 Miscellaneous Documents
9.4.7 Formats and Records
9.5 Food Safety Team Structure
9.6 Let Us Sum Up
9.7 Key Words
9.8 Answers to Check Your Progress Exercise
9.9 Suggested Reading

9.0 OBJECTIVES
After studying this unit, we shall be able to:
• outline the elements of structure of ISO 22000: 2005,
• specify the functionality of each element and their interrelationships, with
each other, and
• state the applicability of the standard to different players in the food chain.

9.1 INTRODUCTION
ISO 22000:2005 is first in family of food safety management system standards
designed to ensure safe food supply worldwide. ISO 22000:2005, requirements
for any organisation in the food chain, provides a framework of internationally
harmonized requirements for the global approach that is needed. The standard
has been developed by ISO with the help of experts from the food industry,
along with representatives of specialized international organisations and in
close cooperation with the Codex Alimentarius Commission, the body jointly
established by the Food and Agriculture Organisation (FAO) and World Health
Organisation (WHO) to develop food standards. A major benefit is that ISO
22000 make it easier for organisations worldwide to implement the Codex
HACCP (Hazard Analysis and Critical Control Point) system for food hygiene
in a harmonized manner, which does not vary with the country of origin of
food product.
Food reaches consumers via supply chains that may link many different types
of organisation and that may stretch across multiple borders. One weak link
can result in unsafe food that is dangerous to health – and when this happens,
the hazards to consumers can be serious and the cost to food chain suppliers
may be considerable. As food safety hazards can enter the food chain at any
stage, adequate control and communication throughout is essential.
Food safety is a joint responsibility of all the players in the food chain and
requires their combined efforts. ISO 22000 is therefore designed to allow all
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ISO 22000:2005 types of organisations within the food chain to implement a food safety
management system. These range from feed producers, primary producers,
food manufacturers, transport and storage operators and subcontractors to retail
and food service outlets – together with related organisations such as producers
of equipment, packaging material, cleaning agents, additives and ingredients.
The standard has become necessary because of the significant increase of
illnesses caused by infected food in both developed and developing countries.
In addition to the health hazards, food borne illnesses can give rise to
considerable economic losses covering medical treatment, absence from work,
insurance payments and legal compensation. As a result, a number of countries
have developed national standards for the supply of safe food and individual
companies and groupings in the food sector have developed their own
standards or programmes for auditing their suppliers. The plethora of more
than 20 different such schemes worldwide generates risks of uneven levels of
food safety, confusion over requirements, and increased cost and complication
for suppliers that find themselves obliged to conform to multiple programmes.

9.2 ECONOMIC LOSS DUE TO FOOD BORNE

ILLNESS
ISO 22000, backed by international consensus, harmonizes the requirements
for systematically managing safety in food supply chains and offers a unique
solution for good practice on a worldwide basis. In addition, food safety
management systems that conform to ISO 22000 can be certified which
answers the growing demand in the food sector for the certification of
suppliers although the standard can be implemented without certification of
conformity, solely for the benefits it provides.

9.3 ISO 22000: 2005 CLAUSES

The standard is divided into eight main clauses as listed below:
1. Scope
2. Normative references
3. Terms and definitions
4. Food Safety Management System
5. Management Responsibility
6. Resource Management
7. Planning and realization of safe products
8. Validation, Verification and improvement of the food safety management
system
These eight clauses are further sub-divided into sub-clauses as listed below:
Main Sub- Sub-Sub- Heading
Clause Clause Clause No.
No. No.
1 - - Scope
2 - - Normative References
3 - - Terms and definitions
4 Food Safety Management System
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Main Sub- Sub-Sub- Heading ISO 22000:2005-
Structure
Clause Clause Clause No.
No. No.
4.1 - General Requirements
4.2 Documentation requirements
4.2.1 General
4.2.2 Control of documents
4.2.3 Control of records
5 Management Responsibility
5.1 - Management Commitment
5.2 - Food Safety Policy
5.3 - Food Safety Management System Planning
5.4 - Responsibility and Authority
5.5 - Food Safety Team Leader
5.6 Communication
5.6.1 External Communication
5.6.2 Internal Communication
5.7 - Emergency Preparedness and Response
5.8 Management Review
5.8.1 General
5.8.2 Review Input
5.8.3 Review Output
6 Resource Management
6.1 - Provision of Resources
6.2 Human Resources
6.2.1 General
6.2.2 Competence, Awareness and Training
6.3 - Infrastructure
6.4 - Work environment
7 Planning and Realization of safe Products
7.1 - General
7.2 Prerequisite programmes (PRPs)
7.2.1 Establish implement and maintain PRPs to control
the likelihood of food safety hazard.
7.2.2 Appropriateness of PRPs and statutory regulatory
requirements related to PRPs.
7.2.3 PRPs as per the information given in various
requirements like statutory, customer’s
requirement, codex requirements etc. and
verification of the PRPs.
7.3 Preliminary steps to enable hazard analysis
7.3.1 General
7.3.2 Food safety team
7.3.3 Product characteristics
Raw materials, ingredients and product-contact
7.3.3.1
materials
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ISO 22000:2005 Main Sub- Sub-Sub- Heading
Clause Clause Clause No.
No. No.
7.3.3.2 Characteristics of end product
7.3.4 Intended use
7.3.5 Flow diagrams, process steps and control measures
7.3.5.1 Flow diagrams
7.3.5.2 Description of process steps and control measures
7.4 Hazard analysis
7.4.1 General
7.4.2 Hazard identification and determination of
acceptance levels
7.4.2.1 Identification of hazards is based on preliminary
information collected, experience and from food
chain.
7.4.2.2 While identifying hazards give consideration to
steps preceding and following the specified
operation, processing equipment, environment,
preceding and following food chain links.
7.4.2.3 Determination of acceptable level of hazard in the
end product aiming at elimination or reduction of
the hazard identified.
7.4.3 Hazard assessment
7.4.4 Selection and assessment of control measures
7.5 - Establishing the operational prerequisite programs
(PRPs)
7.6 Establishing the HACCP plan
7.6.1 HACCP plan
7.6.2 Identification of critical control points (CCPs)
7.6.3 Determination of critical limits for control points
7.6.4 System for the monitoring of critical points
7.6.5 Actions when monitoring results exceed critical
limits.
7.7 - Updating of preliminary information and
documents specifying the PRPs and the HACCP
plan
7.8 - Verification planning
7.9 - Traceability system
7.10 Control of non-conformity
7.10.1 Corrections
7.10.2 Corrective Actions
7.10.3 Handling of potentially unsafe products
7.10.3.1 General
7.10.3.2 Evaluation for release
7.10.3.3 Disposition of non-conforming products
7.10.4 Withdrawals
8 Validation, verification and improvement of the
food safety management system

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Main Sub- Sub-Sub- Heading ISO 22000:2005-
Structure
Clause Clause Clause No.
No. No.
8.1 - General
8.2 - Validation of control measure combinations
8.3 - Control of monitoring and measuring
8.4 Food safety management system verification
8.4.1 Internal audit
8.4.2 Evaluation of individual verification results
8.4.3 Analysis of results of verification activities
8.5 Improvements
8.5.1 Continual improvement
8.5.2 Updating the food safety management system

9.4 FSMS DOCUMENTATION STRUCTURE

The documentation structure consists of different hierarchical levels as
follows:
1. Food Safety Manual
2. Mandatory Procedures
3. Standard Operating Procedures/Work Instructions
4. HACCP Five Pre-steps related documents
5. HACCP Seven Principles related documents
6. Miscellaneous documents
7. Formats and records

9.4.1 Food Safety Manual

Food safety manual is a document which explains how the requirements of
ISO 22000: 2005 are planned to be fulfilled by the Food Processor taking into
consideration the type of food processed, complexity of processing methods,
competence of operating personnel and number of sites where the food safety
management system is implemented.

Food safety manual

Mandatory Procedures

Standard Operating Procedures

HACCP Pre-steps related documents

HACCP Principles related documents

Miscellaneous documents

Formats and records

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ISO 22000:2005 The contents of different hierarchical levels is as follows:
The manual also contains the general information about the Organisation like:
• Establishment and evolution over the years
• The position in the food chain
• The suppliers and customers in the food chain
• The site related details
• Food safety policy and related objectives
• Organisation chart
• Applicable statutory and regulatory requirements
• The structure of FSMS documentation
• The site map from external and internal point of view
• Roles and responsibilities (including food safety team composition)
• Details of external resources utilized
The manual gives reference to or contains all the elements of the FSMS
documentation. It acts as a reference document for training of new team
members of the Organisation, communicating the FSMS overview to National
and International customers and as a supporting document during any statutory
and regulatory interaction.
The manual is required to be reviewed periodically by the top management and
Food Safety Team members in management review meetings. The relevant
inputs to be reviewed in the meeting are required to be collected from different
processes constituting the food safety management system.

9.4.2 Mandatory Procedures

The following documented procedures are required to be established and
maintained.
• Control of documents
• Control of records
• Emergency preparedness and response
• Control of non-conformity (it is covered in corrective action)
• Corrective actions
• Internal audit
• Withdrawals
Contents of the documented procedures are as follows:
• Control of documents
This procedure contains information related to approval of documents, re-
approval of documents, identification of changes, identification of current
revision status, availability of relevant versions at points of use, legibility,
documents of external origin and management of obsolete documents.

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 A master list of documents is prepared which gives details like document ISO 22000:2005-
Structure
name, document number, issue date, current revision number and date,
information about preparation, review and approval of the documents.
• Control of records
This procedure defines controls needed for the identification, storage,
protection, retrieval, retention time and disposal of records. A master list
of records is prepared which gives details like - record name, associated
format number and issue date, version of record (soft/hard), record
originating process etc.
• Emergency preparedness and response
This procedure contains the information about potential emergency
situations relevant to the food processing Organisation and the accidents
which are likely to happen in case the preparedness and response is not
adequate.
• Control of non-conformity
This procedure contains the information about the identification and
assessment of potentially unsafe end products to determine their proper
handling and review of the corrections carried out. It also specifies the
records required to be maintained.
• Corrective actions
This procedure contains information related to review of non-conformities
(including customer complaints), review of trends in monitoring results,
determination of causes of non-conformities, evaluating the need for the
action, determining and implementing the actions needed, recording the
results and reviewing corrective actions taken.
• Internal audits
This procedure contains the responsibility and requirements for planning
and conducting audits, and for reporting results and records. It also
contains the details of competence of the internal audit team members.
• Withdrawl
This procedure contains information related to timely withdrawl of lots of
end products which have been identified as unsafe, with responsibilities for
executing the withdrawl.

9.4.3 Standard Operating Procedures (SOP)/ Work

Instructions
The following SOPs are required to be maintained:
• Procedure for training
• Procedure for internal communication
• Procedure for external communication
• Procedure for maintenance
• Procedure for verification planning
• Procedure for traceability
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ISO 22000:2005 • Procedure for handling potentially unsafe products
• Procedure for withdrawal and recall
• Procedure for Purchase
• Procedure for verification of purchased product
• Procedure for raw material stores
• Procedure for finished goods stores
• Procedure for dispatch
• Procedure for handling customer complaints

9.4.4 HACCP Pre-steps Related Documents

Following documents are required to give evidence of following of HACCP
pre-steps.
• Formation of HACCP team
• Product description (raw material, ingredients and product contact
materials)
• Product description (characteristics of end product)
• Intended use of end product
• Preparation of flow diagram
• Description of process steps and control measures (including prerequisite
program)

9.4.5 HACCP Principles Related Documents

Following documents are required to give evidence of following of HACCP
principles.
• Hazard identification and determination of acceptable levels
• Hazard assessment
• Selection and assessment of control measures
• Establishing Operational Prerequisite program
• Establishing HACCP plan
• Identification of Critical Control Points
• Determination of Critical Limits for Critical Control Points
• System for monitoring Critical control points
• Validation support for established FSMS

9.4.6 Miscellaneous Documents

Following miscellaneous documents are required to be maintained:
• Statutory and regulatory requirements
• Documents of external origin
• Food safety policy
• Food safety objectives
• List of available resources

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• List of role-wise necessary competence ISO 22000:2005-
Structure
• Customer requirements
• Country specific requirements
• Technical documents (research articles etc.)

9.4.7 Formats and Records

Following records are required to be maintained in pre-determined formats:
• Current competence of all concerned (including food safety team members)
• Calibration of measuring and monitoring instruments
• Outcome of internal audits
• Output of management review
• Verification of FSMS
• Verification of flow-chart
• Effectiveness of withdrawal program
• Corrective actions
• Analysis of results of verification activities
• Training and effectiveness of training given
• Monitoring of CCPs
• Corrections of non-conforming products
• Verification of purchased product
• Release of end product
• Receipt and issue of material in stores
• Maintenance (breakdown and preventive)
• Food safety objective tracking
• Document change control
• Document distribution

9.5 FOOD SAFETY TEAM STRUCTURE

Top Management

Corporate Food safety Team Leader

Site Food safety team leaders

Corporate deputy FS team leader

Site deputy FS team leaders

Corporate/site FS team members

Operational Personnel

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ISO 22000:2005 A food safety team is required to be appointed by top management. The team
should consist of food safety team leader, deputy leader and food safety team
members having combination of multidisciplinary knowledge and experience
in developing and implementing the food safety management system including
Organisation's products, processes, equipment and food safety hazards within
the scope of the food safety management system.
Competence of food safety management team in terms of necessary education,
training, skills and experience should be established. The available competence
should be mapped with respect to the necessary competence and ensuring gaps
should be filled in a planned manner.
The food safety team is responsible for establishing, documenting,
implementing, maintaining and reporting on necessary and possible
improvements with respect to food safety management system. External
resource having necessary competence may be inducted as invitee in the food
safety team meetings. The food safety team acts as an interface between top
management and operational food safety management system. It also acts as
liaisoning agent between food processing Organisation and external parties like
consultants, registrars and statutory and regulatory authorities.

# Check Your Progress Exercise 1

Note: a) Use the space below for your answers.
b) Compare your answers with those given at the end of the unit.
1) List the elements of structure of FSMS documentation?
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2) List any five mandatory procedures?
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3) List any five mandatory records?
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4) List any five miscellaneous documents?
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5) Explain the purpose of emergency preparedness and response procedure? ISO 22000:2005-
Structure
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6) List main elements of FS team structure?

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9.6 LET US SUM UP

Food Safety Management System Standard 22000:2005 has been jointly
formulated by FAO and WHO. A major benefit of 22000:2005 is that it make
it easier for organisations worldwide to implement the codex HACCP system
for food hygiene in a harmonized manner, which does not vary with the
country of origin of food. Food safety is the joint responsibility of all the
players in the food chain and require their combined effort. Structure of food
safety management system standard include documentation structure
consisting food safety manual, mandatory procedures, SoPs/work instructions,
HACCP Five and given principles related documents, miscellaneous
documents and formats and records. It also consist food safety team structure
which include a team leader, deeply leader and members. This team is
responsible for establishing, documenting, implementing, maintaining and
reporting on necessary and possible improvements with respect to food safety
management system.

9.7 KEY WORDS

CCP : A critical control point (CCP) is the point (or step) at which a
control measure must be applied. It is a point that is critical or
essential to safety. It is the point where a control measure can
be used to prevent or eliminate a food safety hazard or to
reduce it to an acceptable level.
FSMS : A food safety management system (FSMS) is a network of
interrelated elements that combine to ensure that food does not
cause adverse human health effects. These elements include
programs, plans, policies, procedures, practices, processes,
goals, objectives, methods, controls, roles, responsibilities,
relationships, documents, records, and resources. A FSMS is
often one part of a larger management system.
Food : A food safety policy statement formally defines an
Safety Organisation's commitment to food safety. It expresses, in
Policy general terms, what top management intends to do about food
safety and describes the direction of the Organisation wishes to
take.
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ISO 22000:2005 HACCP : HACCP stands for Hazard Analysis and Critical Control
Point. HACCP is a methodology and a management system. It
is used to identify, prevent and control food safety hazards.

# 9.8 ANSWERS TO CHECK YOUR PROGRESS

EXERCISE
Your answer should include following points:
Check Your Progress Exercise 1
1) • Food Safety Manual
• Mandatory Procedures
• Standard Operating Procedures/Work Instructions
• HACCP Five Pre-steps related documents
• HACCP Seven Principles related documents
• Miscellaneous documents
• Formats and records
2) • Control of documents
• Control of records
• Emergency preparedness and response
• Control of non-conformity
• Corrective actions
3) • Current competence of all concerned (including food safety team
members)
• Calibration of measuring and monitoring instruments
• Outcome of internal audits
• Output of management review
• Verification of FSMS
4) • Statutory and regulatory requirements
• Documents of external origin
• Food safety policy
• Food safety objectives
• List of available resources
5) • Identification of potential emergency situations relevant to the food
processing Organisation and the accidents which are likely to happen.
• Planning the preparedness with reference to identified emergencies.
• Planning of responding to emergency situations.
6) • Top management
• Food safety team leader
• Food safety deputy team leader
• food safety team members

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 ISO 22000:2005-
9.9 SUGGESTED READING Structure

www.iso.org
www.codexalimantarius.net
CAC/RCP- 1 - 1969 (Rev. 4 2003) – Recommended code of practice.
ISO 9001: 2000
Codex Alimentarius – Food hygiene basic text.

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