Version 6 FSSC 22000

Implementing an FSSC 22000 Version 6
Compliant Food Safety Management System

Tony Connor
Chief Technical Advisor, IFSQN
FSSC 22000 Certification Scheme
FSSC 22000 was developed to facilitate broader acceptance of ISO 22000 Food
safety management systems - Requirements for any organization in the food
chain and recognition by the Global Food Safety Initiative (GFSI).
The FSSC 22000 Food Safety System Certification Scheme provides a

framework for food safety management based on ISO Standards.
The FSSC 22000 Scheme was first published in 2009 and there are currently
over 34,000 FSSC 22000 certified organizations worldwide.
Source: https://www.fssc.com/schemes/fssc-22000/
In order to clarify the requirements for PRPs and to allow for
recognition by the Global Food Safety Initiative (GFSI) of the Consumer
Goods Forum, industry stakeholders have developed detailed technical
specifications covering sector pre-requisite programs (PRPs) which are
used in addition to ISO 22000.
FSSC 22000 provides a certification scheme for such industry sectors
where such a technical specification for sector PRPs has been integrated
into the category scope.
FSSC 22000 SCHEME VERSION 6
The audit requirements for FSSC 22000 certification consist of:
1) ISO 22000:2018 food safety management system requirements;
2) sector specific prerequisite program (PRPs) requirements
(ISO/TS 22002-x series or other specified PRP standard) and;
3) FSSC 22000 Additional requirements.
FSSC 22000 Additional requirements fill the gaps between the GFSI
Benchmark requirements and ISO 22000/ISO/TS 22002-x standards
thus enabling the FSSC 22000 Certification Scheme to be
recognised by GFSI.
The FSSC 22000 Certification Scheme is
recognised by GFSI.
FSSC 22000 Requirements - Prerequisite programmes
for Supply Chain Sector
ISO/TS 22002-1:2009 Prerequisite programmes on food safety -- Part 1: Food
manufacturing
ISO/TS 22002-2:2013 Prerequisite programmes on food safety -- Part 2:
Catering
Farming (Note: Category A Farming removed from Scope of FSSC 22000 V6)
ISO/TS 22002-4:2013 Prerequisite programmes on food safety -- Part 4: Food
packaging manufacturing
Transport and storage
ISO/TS 22002-6:2016 Prerequisite programmes on food safety -- Part 6: Feed
and animal food production
BSI/PAS 221:2013 Prerequisite programmes for food safety in food retail
The FSSC 22000 Scheme Version 6
was published in April 2023.
The FSSC 22000-Quality program is being

discontinued.
From 1 April 2024, no further FSSC
22000-Quality audits shall be delivered.
FSSC 22000 Food Categories
(Note: Category A Farming

removed from the Scope of
FSSC 22000 V6)
FSSC 22000 SCHEME VERSION 6 | APRIL 2023
Part II: REQUIREMENTS

FOR ORGANIZATIONS TO
BE AUDITED
Part II: REQUIREMENTS FOR ORGANIZATIONS TO BE AUDITED
2 REQUIREMENTS
2.1 GENERAL
2) sector specific prerequisite program (PRPs) requirements (ISO/TS
22002-x series or other specified PRP standard) and;
FSSC 22000 Version 6 Requirements
ISO/TS 22002-1 Prerequisite programmes on food
safety -- Part 1: Food manufacturing is applicable
to Food Sector Categories/Sub-categories:
BIII Pre-process handling of plant products

C0 Animal – Primary conversion
CI Processing of perishable animal products
CII Processing of perishable plant-based products
CIII Processing of perishable animal and plant products (mixed products)
CIV Processing of ambient stable products
K Production of Bio/chemicals
What is ISO 22000?
ISO 22000 is an international standard that specifies
requirements for a food safety management system where an
organization in the food chain needs to demonstrate compliance
with food safety requirements.
About ISO 22000
ISO 22000 combines generally recognized key elements to
ensure food safety along the food chain :
✓ Interactive Communication
✓ HACCP Principles
✓ System Management
✓ Prerequisite programmes
Interactive Communication
Clear communication along the food chain is essential to ensure
that all relevant food safety hazards are identified and
adequately controlled at each step.
HACCP Principles
ISO 22000 combines the Codex Alimentarius HACCP (Hazard
Analysis and Critical Control Points) principles and application
steps, developed by Codex Alimentarius, with prerequisite
programmes.
Prerequisite Programmes
The effective production of safe products requires a detailed
Hazard Control Plan and the integration of Prerequisite
Programmes.
Management Principles common to ISO Management
System Standards
In addition, ISO 22000 is based on management principles that are common
to ISO management system standards:
✓ Customer Focus
✓ Leadership
✓ Engagement of People
✓ Process Approach
✓ Improvement
✓ Evidence-Based Decision Making
✓ Relationship Management
4 Context of
4 Context of the
the organization
organization
10
10 5 Leadership
5 Leadership Improvement
Improvement
ISO 22000 ISO 9001

9 Sections 9
Performance
Sections 6 Planning
Performance 6 Planning evaluation
evaluation
8 Operation 7 Support
8 Operation 7 Support
System Management
ISO 22000 aligned with ISO 9001
ISO 22000 is aligned with the requirements of ISO 9001 in order
to enhance the compatibility of the two standards and to ease
their joint or integrated implementation.
ISO 9001:2015 Quality management systems — Requirements vs. ISO 22000:2018 Food
safety management systems — Requirements for any organization in the food chain
International ISO Standard 9001:2015 Quality management systems — Requirements vs. International ISO Standard 22000: 2018 Food safety management systems —
Requirements for any organization in the food chain
ISO 9001:2015 ISO 22000:2018
4 Context of the organization 4 Context of the organization
4.1 Understanding the organization and its context 4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties 4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management 4.3 Determining the scope of the food safety management system
4.4 Quality management system and its processes 4.4 Food safety management system
5 Leadership 5 Leadership
5.1 Leadership and commitment 5.1 Leadership and commitment
5.1.1 General
5.1.2 Customer focus
5.2 Policy 5.2 Policy
5.2.1 Establishing the quality policy 5.2.1 Establishing the food safety policy
5.2.2 Communicating the quality policy 5.2.2 Communicating the food safety policy
5.3 Organizational roles, responsibilities and authorities 5.3 Organizational roles, responsibilities and authorities
6 Planning 6 Planning
6.1 Actions to address risks and opportunities 6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them 6.2 Objectives of the food safety management system and planning to achieve them
6.3 Planning of changes 6.3 Planning of changes
7 Support 7 Support
7.1 Resources 7.1 Resources
7.1.1 General 7.1.1 General
7.1.2 People 7.1.2 People
7.1.3 Infrastructure 7.1.3 Infrastructure
7.1.4 Environment for the operation of processes 7.1.4 Work environment
7.1.5 Monitoring and measuring resources 7.1.5 Externally developed elements of the food safety management system
7.1.6 Organizational knowledge 7.1.6 Control of externally provided processes, products or services
ISO 9001:2015 ISO 22000:2018
7.2 Competence 7.2 Competence
7.3 Awareness 7.3 Awareness
7.4 Communication 7.4 Communication
7.4.1 General
(8.2.1 Customer communication) 7.4.2 External communication
7.4.3 Internal communication
7.5 Documented information 7.5 Documented information
7.5.2 Creating and updating 7.5.2 Creating and updating
7.5.3 Control of documented information 7.5.3 Control of documented information
8 Operation 8 Operation
9 Performance evaluation 9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation 9.1 Monitoring, measurement, analysis and evaluation
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation 9.1.2 Analysis and evaluation
9.2 Internal audit 9.2 Internal audit
9.3 Management review 9.3 Management review
9.3.2 Management review inputs 9.3.2 Management review input
9.3.3 Management review outputs 9.3.3 Management review output
10 Improvement 10 Improvement
10.1 General
10.2 Nonconformity and corrective action 10.1 Nonconformity and corrective action
10.3 Continual Improvement 10.2 Continual improvement
10.3 Update of the food safety management system
ISO 9001:2015
8 Operation
8.1 Operational planning and control
8.2 Requirements for products and services
8.2.1 Customer communication
8.3 Design and development of products and services
(8.5.2 Identification and traceability)
8.4 Control of externally provided processes, products and services
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes
8.6 Release of products and services
8.7 Control of nonconforming outputs
ISO 22000:2018 Section 8 Operation
8 Operation 8.5.3 Validation of control measure(s) and combinations of control
8.1 Operational planning and control measures
8.2 Prerequisite programmes (PRPs) 8.5.4 Hazard control plan (HACCP/OPRP plan)
8.3 Traceability system 8.5.4.1 General
8.4 Emergency preparedness and response 8.5.4.2 Determination of critical limits and action criteria
8.4.1 General 8.5.4.3 Monitoring systems at CCPs and for OPRPs
8.4.2 Handling of emergencies and incidents 8.5.4.4 Actions when critical limits or action criteria are not met
8.5 Hazard control 8.5.4.5 Implementation of the hazard control plan
8.5.1 Preliminary steps to enable hazard analysis 8.6 Updating the information specifying the PRPs and the hazard control
8.5.1.1 General plan
8.5.1.2 Characteristics of raw materials, ingredients and product contact materials 8.7 Control of monitoring and measuring
8.5.1.3 Characteristics of end products 8.8 Verification related to PRPs and the hazard control plan
8.5.1.4 Intended use 8.8.1 Verification
8.5.1.5 Flow diagrams and description of processes 8.8.2 Analysis of results of verification activities
8.5.1.5.1 Preparation of the flow diagrams 8.9 Control of product and process nonconformities
8.5.1.5.2 On-site confirmation of flow diagrams 8.9.1 General
8.5.1.5.3 Description of processes and process environment 8.9.2 Corrections
8.5.2 Hazard analysis 8.9.3 Corrective actions
8.5.2.1 General 8.9.4 Handling of potentially unsafe products
8.5.2.2 Hazard identification and determination of acceptable levels 8.9.4.1 General
8.5.2.3 Hazard assessment 8.9.4.2 Evaluation for release
8.5.2.4 Selection and categorization of control measure(s) 8.9.4.3 Disposition of nonconforming products
8.9.5 Withdrawal/recall
Plan
Plan Do Check Act Cycle 4 Context of the
organization
5 Leadership
Overall framework of the Food 6 Planning
7 Support *
Safety Management System and
corresponding ISO 22000:2018
Sections
Act Do
10.
8. Operation **
Improvement
* Plus control of external processes,

products & services
** See Operational PDCA Cycle Check
9. Performance
evaluation
ISO 22000 Section 4 Context of the organization
4.1 Understanding the organization and its context
Section 4 Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of
interested parties
Section 4 Context of the organization
4.3 Determining the scope of the food safety

management system – Also considering 4.1 & 4.2
4.4 Food safety management system
ISO 22000 Section 5 Leadership
5.1 Leadership and commitment
Section 5 Leadership includes:
5.2 Policy
5.2.1 Establishing the food safety policy
5.2.2 Communicating the food safety policy
5.3 Organizational roles, responsibilities and authorities
5.3 Organizational roles, responsibilities and authorities
ISO 22000 Section 6 Planning
Section 6 Planning includes:
6.1 Actions to address risks and opportunities
6.2 Objectives of the food safety management system and
planning to achieve them
6.3 Planning of changes
6.2 Objectives of the food safety management system and planning to achieve them
The objectives of the FSMS shall:

a) be consistent with the food safety policy;
b) measurable
c) take into account applicable food safety requirements,
including statutory, regulatory and customer requirements;
d) monitored and verified;
e) communicated;
f) maintained and updated
6.2 Objectives of the food safety management system and planning to achieve them
When planning how to achieve its objectives for the

FSMS, the organization shall determine:
a) what will be done;
b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated.
6.3 Planning of changes
ISO 22000 Section 7 Support
Section 7 Support includes:
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Work environment
7.1.5 Externally developed elements of the food
safety management system
7.1.6 Control of externally provided processes,
products or services
7.2 Competence
7.3 Awareness
7.4 Communication
7.4.1 General
7.4.2 External communication
7.4.3 Internal communication
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented information
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented information
Operational Planning and Control
This PDCA Cycle for Section 8 Operation includes:
8.2 Prerequisite programmes (PRPs)
8.3 Traceability system
8.4 Emergency preparedness and response
8.4.1 General
8.4.2 Handling of emergencies and incidents
8.5 Hazard control
8.5.1 Preliminary steps to enable hazard analysis
8.5.1.1 General
8.5.1.2 Characteristics of raw materials, ingredients and product contact materials
8.5.1.3 Characteristics of end products
8.5.1.4 Intended use
8.5.1.5 Flow diagrams and description of processes
8.5.1.5.1 Preparation of the flow diagrams
8.5.1.5.2 On-site confirmation of flow diagrams
8.5.1.5.3 Description of processes and process environment
8.5.2 Hazard analysis
8.5.2.1 General
8.5.2.2 Hazard identification and determination of acceptable levels
8.5.2.3 Hazard assessment
8.5.2.4 Selection and categorization of control measure(s)
8.5.3 Validation of control measure(s) and combinations of control measures
8.5.4 Hazard control plan (HACCP/OPRP plan)
8.5.4.1 General
8.5.4.2 Determination of critical limits and action criteria
8.5.4.3 Monitoring systems at CCPs and for OPRPs
8.5.4.4 Actions when critical limits or action criteria are not met
8.5.4.5 Implementation of the hazard control plan
8.6 Updating the information specifying the PRPs and the hazard control plan
8.7 Control of monitoring and measuring
8.8 Verification related to PRPs and the hazard control plan
8.8.1 Verification
8.8.2 Analysis of results of verification activities
8.9 Control of product and process nonconformities
8.9.1 General
8.9.2 Corrections
8.9.3 Corrective actions
8.9.4 Handling of potentially unsafe products
8.9.4.1 General
8.9.4.2 Evaluation for release
8.9.4.3 Disposition of nonconforming products
ISO 22000 Section 8 Operation
Section 8 Operation includes requirements for:

8.2 Prerequisite programmes (PRPs)
8.4.1 General
8.4.2 Handling of emergencies and incidents
BACK TO: 8.2 Prerequisite programmes (PRPs)

Prerequisite Programmes
Prerequisites programmes are established, implemented, maintained, reviewed,
improved and updated to assist in:
✓ Controlling or preventing the introduction of food safety hazards through the
work environment.
✓ To eliminate, prevent or reduce to an acceptable level the biological, chemical
and physical contamination of the product(s) including cross contamination
between products.
✓ To control, minimize and/or prevent food safety hazard levels in the finished
product, ingredients and product processing environment.
ISO 22000 Requirement for Prerequisite programmes
ISO 22000 requires that effective control measures should be in place to
reduce the risk of contamination of the food, when establishing PRP(s)
the organization shall consider:
a) construction, lay-out of buildings and associated utilities;

b) lay-out of premises, including zoning, workspace and employee
facilities;
c) supplies of air, water, energy and other utilities;
d) pest control, waste and sewage disposal and supporting services;
e) the suitability of equipment and its accessibility for cleaning and
maintenance;
ISO 22000 requires that effective control measures should be in place to
reduce the risk of contamination of the food, when establishing PRP(s) the
organization shall consider:
f) supplier approval and assurance processes (e.g. raw materials,

ingredients, chemicals and packaging);
g) reception of incoming materials, storage, dispatch, transportation and
handling of products;
h) measures for the prevention of cross contamination;
i) cleaning and disinfecting;
j) personal hygiene;
k) product information/consumer awareness;
l) others, as appropriate.
8.2.1 The organization shall establish, implement, maintain and update PRP(s)
to facilitate the prevention and/or reduction of contaminants (including food
safety hazards) in the products, product processing and work environment.
8.2.2 The PRP(s) shall be:
a) appropriate to the organization and its context with regard to food safety;
b) appropriate to the size and type of the operation and the nature of the
products being manufactured and/or handled;
c) implemented across the entire production system, either as programmes
applicable in general or as programmes applicable to a particular product or
process;
d) approved by the food safety team.
8.2.3 When selecting and/or establishing PRP(s), the
organization shall ensure that applicable statutory,
regulatory and mutually agreed customer
requirements are identified.
The organization should consider:

a) the applicable part of the ISO/TS 22002 series;
b) applicable standards, codes of practice and
guidelines.
Training - Prerequisite programmes
Training
All food handlers should be trained in personal hygiene, as well as in the
specific operation with which they are working, to a level commensurate
with their duties.
An ongoing training programme for key personnel is paramount to the
success of a Food Safety Management System.
8.2.3 a) The organization should consider the applicable part of the ISO/TS 22002 series.
This standard will be replaced

by ISO/CD 22002-1 which is
under development
ISO/TS 22002-1 requirements
ISO/TS 22002-1 specifies detailed requirements to be specifically considered in relation to
ISO 22000 clause 8.2.4:
ISO 22000:2018 Clause 8.2.4 ISO/TS 22002-1:2009 Sections
a) construction, lay-out of buildings and associated utilities; 4 Construction and layout of buildings
b) lay-out of premises, including zoning, workspace and 5 Layout of premises and workspace
employee facilities;
c) supplies of air, water, energy and other utilities; 6 Utilities – air, water, energy
d) pest control, waste and sewage disposal and supporting 7 Waste disposal
services; 12 Pest control
e) the suitability of equipment and its accessibility for cleaning 8 Equipment suitability, cleaning and maintenance
and maintenance;
f) supplier approval and assurance processes (e.g. raw materials, 9 Management of purchased materials
ingredients, chemicals and packaging);
g) reception of incoming materials, storage, dispatch, 16 Warehousing
transportation and handling of products;
h) measures for the prevention of cross contamination; 10 Measures for prevention of cross contamination
i) cleaning and disinfecting; 11 Cleaning and sanitizing
j) personal hygiene; 13 Personnel hygiene and employee facilities
k) product information/consumer awareness; 17 Product information/consumer awareness
l) others, as appropriate. 14 Rework
15 Product recall procedures
TS ISO 22002-1 Prerequisite Programme Requirements
4. Construction and layout of buildings:
✓ 4.1 General requirements

✓ 4.2 Environment
✓ 4.3 Locations of establishments
4. Construction and layout of buildings:

✓ 4.2 Environment
✓ 4.3 Locations of establishments
Requirements for appropriate buildings in terms of construction

including durable materials, design and maintenance.
Requirements to control any environmental risks.
Requirements to maintain the site and control access.
5. Layout of premises workspace:

✓ 5.2 Internal design, layout and traffic patterns
✓ 5.3 Internal structures
✓ 5.4 Location of equipment
✓ 5.5 Laboratory facilities
✓ 5.6 Temporary/mobile premises and vending machines
✓ 5.7 Storage of food, packaging materials, ingredients and non food
chemicals
5. Layout of premises workspace
Internal layouts need to be designed, constructed and maintained to
facilitate good hygiene and manufacturing practices.
Requirements for appropriate internal structures and fittings including
ceilings, doors, drains, floors and walls.
Requirements for equipment design, maintenance and location such that its
operation is hygienic.
Requirements for laboratory facilities, storage facilities and temporary
structures.
5. Layout of premises workspace
Internal layouts need to be designed, constructed and maintained to

facilitate good hygiene and manufacturing practices.
Requirements for appropriate internal structures and fittings
including ceilings, doors, drains, floors and walls.
Requirements for equipment design, maintenance and location such
that its operation is hygienic.
Requirements for laboratory facilities, storage facilities and
temporary structures.
6. Utilities – air, water, energy
✓ 6.2 Water supply
✓ 6.3 Boiler chemicals
✓ 6.4 Air quality ventilation
✓ 6.5 Compressed air and other gases
✓ 6.6 Lighting
6. Utilities – air, water, energy
Utility supplies and distribution routes to and around processing and

storage areas need to minimize the risk of product contamination.
Appropriate treatments such as filtration should be in place.
The quality of utility supplies needs to be monitored to minimize
product contamination risk.
Lighting should be adequate and fittings not represent a risk of
product contamination.
7. Waste disposal
✓ 7.2 Containers for waste and inedible or hazardous substances
✓ 7.3 Waste management and removal
✓ 7.4 Drains and drainage
TS ISO 22002-1
Prerequisite Programme Requirements
7. Waste disposal
Systems should ensure that waste materials are identified,

collected, removed and disposed of in a manner that
prevents contamination of the facility and products.
8. Equipment suitability, cleaning and maintenance

✓ 8.2 Hygienic design
✓ 8.3 Product contact surfaces
✓ 8.4 Temperature control and monitoring equipment
✓ 8.5 Cleaning plant, utensils and equipment
✓ 8.6 Preventive and corrective maintenance
TS ISO 22002-1
8. Equipment suitability, cleaning and maintenance
Food contact equipment must be of hygienic design

and constructed to facilitate cleaning, disinfection and
maintenance.
Risks of indirect contact should be managed.

9. Management of purchased materials

✓ 9.2 Selection and management of suppliers
✓ 9.3 Incoming material requirements (raw/ingredients/packaging)
TS ISO 22002-1
Systems should be in place for the purchase and

verification of materials which impact food safety are
controlled to ensure that the suppliers and materials
supplied meet specified requirements.
Systems should be in place for the purchase and verification of
materials which impact food safety are controlled to ensure that the
suppliers and materials supplied meet specified requirements.
Incoming Materials
10. Measures for prevention of cross contamination
✓ 10.2 Microbiological cross contamination
✓ 10.3 Allergen management
✓ 10.4 Physical contamination
Systems should be in place to prevent, control and

detect product contamination including allergen,
microbiological and physical contamination.
TS ISO 22002-1
Systems should be in place to prevent, control and detect

product contamination including allergen, microbiological
and physical contamination.
Allergen Management Tools
Allergen Management – Validation & Verification of Cleaning
Performance
Food Contact Surface – Filler Nozzle
Verification Monitoring method:

ATP Swab after cleaning before Start Up
Validation/Verification Monitoring method
Action Limits:
< 10 rlu – Okay to Start Up
10 – 20 rlu – Sanitise and Re-Swab
> 20 rlu – Full Clean and Re-Swab
11. Cleaning and sanitizing
✓ 11.2 Cleaning and sanitizing agents and tools
✓ 11.3 Cleaning and sanitizing programmes
✓ 11.4 Cleaning in place (CIP) systems
✓ 11.5 Monitoring sanitation effectiveness
TS ISO 22002-1
11. Cleaning and sanitizing
Cleaning and sanitizing programmes should ensure that food-

processing equipment and environment are maintained in a
hygienic condition. The effectiveness of cleaning should be
monitored.
ISO/TS 22002-1 requirements
12th April 2023 12th April 2023 12th April 2023

11.5 Monitoring sanitation effectiveness
Acceptable and Unacceptable Cleaning Performance
Monitoring method:
ATP Swab after cleaning before Start
Up
Action Limits:
10 – 30 rlu – Sanitise and Reswab
> 30 rlu – Full Clean and Reswab
11.5 Monitoring sanitation effectiveness
12. Pest control
✓ 12.2 Pest control programmes
✓ 12.3 Preventing access
✓ 12.4 Harbourage and infestations
✓ 12.5 Monitoring and detection
✓ 12.6 Eradication
12. Pest control
Pest prevention measures should be in place to minimize the risk

of pest infestation by ensuring the environment is hygienic,
inspecting incoming materials and preventing access/harbourage.
Systems for monitoring and detection of pest should be in place
such that any infestation is eradicated.
13 Personnel hygiene and employee facilities
✓ 13.2 Personnel hygiene facilities and toilets
✓ 13.3 Staff canteens and designated eating areas
✓ 13.4 Work wear and protective clothing
✓ 13.5 Health status
✓ 13.6 Illness and injuries
✓ 13.7 Personal cleanliness
✓ 13.8 Personal behaviour
Personal Hygiene
Personal Hygiene
Documented
hygiene
Control of policy
Hand-
Personal
washing
Items
Control of
Protective
Clothing Personal Boils, Cuts,
Grazes
Hygiene
Control of
Illness
personal
Notification
medicines
Health Control of
Status Visitors
Personal Hygiene
Medical Screening
There should be:
✓ Illness notification procedures for employees

✓ Illness notification procedures for visitors
✓ Documented infectious disease procedure
Medical Screening
Conditions which should be reported to management so that any need for medical
examination and/or possible exclusion from food handling can be considered,
include:
• jaundice
• diarrhoea
• vomiting
• fever
• sore throat with fever
• visibly infected skin lesions (boils, cuts, etc.)
• discharges from the ear, eye or nose
Protective Clothing:
Employees and Visitors to Production Areas
Protective Clothing:
Employees and Visitors to Production Areas
Hygiene Policy
The company should have a documented hygiene policy that is

followed at all times:
TS ISO 22002-1
Personal hygiene and behaviors should be established

proportional to the hazard posed to the process area or product.
Appropriate standards of facilities, toilets and work wear should
be provided.
TS ISO 22002-1
Personal hygiene and behaviors should be established

proportional to the hazard posed to the process area or product.
Appropriate standards of facilities, toilets and work wear should
be provided.
14. Rework

✓ 14.2 Storage, Identification and traceability
✓ 14.3 Rework usage
TS ISO 22002-1
14. Rework

✓ 14.2 Storage, Identification and traceability
✓ 14.3 Rework usage
Systems should be in place to ensure that rework is stored,

handled and used such that product safety, traceability and
regulatory compliance are maintained.
15. Product recall procedures

✓ 15.2 Product recall requirements
Product recall procedures should ensure that

products can be identified, located and removed
from all necessary points of the supply chain.
16. Warehousing

✓ 16.2 Warehousing requirements
✓ 16.3 Vehicles, conveyances and containers
Materials and products need to be stored in clean, dry, ventilated

spaces and protected from dust, condensation, fumes, odors or
other sources of contamination.
16. Warehousing


16. Warehousing


17. Product information /consumer awareness
✓ 17.1 Product information
✓ 17.2 Labelling of pre-packaged foods
Product information should be presented to consumers in such
a way as to enable them to understand its importance and
make informed choices.
17. Product information /consumer awareness
✓ 17.1 Product information

✓ 17.2 Labelling of pre-packaged foods
Product information should be presented to consumers in such

a way as to enable them to understand its importance and
make informed choices.
18. Food defence, biovigilance and bioterrorism

✓ 18.2 Access controls
Management should assess the hazard to products

posed by potential acts of sabotage, vandalism or
terrorism and put in place proportional protective
measures including access controls.

Management should assess the hazard to products posed by

potential acts of sabotage, vandalism or terrorism and put in
place proportional protective measures including access controls.

Management should assess the hazard to products posed by

potential acts of sabotage, vandalism or terrorism and put in
place proportional protective measures including access controls.
When selecting and/or establishing PRP(s), the food safety team will need to consider
and utilize appropriate information such as statutory and regulatory requirements,
customer requirements, recognized guidelines, Codex Alimentarius Commission (Codex)
principles and codes of practices, national, international or sector standards.
Section 8 Operation 8.5 Hazard control

8.5 Hazard control
8.5.1.2 Characteristics of raw materials, ingredients
and product contact materials
The organization shall ensure that all applicable
statutory and regulatory food safety requirements
are identified for all raw materials, ingredients and
product contact materials.
The organization shall maintain documented
information concerning all raw materials, ingredients
and product contact materials …
Section 8 Operation 8.5.1.2
The organization shall maintain documented information concerning all raw materials,
ingredients and product contact materials to the extent needed to conduct the hazard
analysis (see 8.5.2), including the following, as appropriate:
a) biological, chemical and physical characteristics;
b) composition of formulated ingredients, including additives and processing aids;
c) source (e.g. animal, mineral or vegetable);
d) place of origin (provenance);
e) method of production;
f) method of packaging and delivery;
g) storage conditions and shelf life;
h) preparation and/or handling before use or processing;
i) acceptance criteria related to food safety or specifications of purchased materials
and ingredients appropriate to their intended use.
8.5.1.2 Characteristics of raw materials, ingredients and
product contact materials
The organization shall ensure that all applicable
statutory and regulatory food safety requirements
are identified for all the end products intended to
be produced.
The organization shall maintain documented
information concerning the characteristics of end
products to the extent needed to conduct the
hazard analysis (see 8.5.2)
The organization shall maintain documented information concerning the
characteristics of end products to the extent needed to conduct the hazard
analysis (see 8.5.2), including information on the following, as appropriate:
a) product name or similar identification;
b) composition;
c) biological, chemical and physical characteristics relevant for food safety;
d) intended shelf life and storage conditions;
e) packaging;
f) labelling relating to food safety and/or instructions for handling,
preparation and intended use;
g) method(s) of distribution and delivery.
8.5.1.4 Intended use
The intended use, including reasonably expected
handling of the end product and any unintended use
but reasonably expected mishandling and misuse of
the end product, shall be considered and shall be
maintained as documented information to the extent
needed to conduct the hazard analysis (see 8.5.2).
Where appropriate, groups of consumers/users shall
be identified for each product.
Groups of consumers/users known to be especially
vulnerable to specific food safety hazards shall be
identified.
8.5.1.5 Flow diagrams and description of processes
8.5.1.5.1 Preparation of the flow diagrams
8.5.1.5.2 On-site confirmation of flow diagrams
8.5.1.5.3 Description of processes and process environment
The food safety team shall describe, to the extent needed to
conduct the hazard analysis:
a) the layout of premises, including food and non-food
handling areas;
b) processing equipment and contact materials, processing
aids and flow of materials;
c) existing PRPs, process parameters, control measures (if
any)
d) external requirements
The variations resulting from expected seasonal changes or
shift patterns shall be included as appropriate.
8.5.2.1 General
8.5.2.2 Hazard identification and determination
of acceptable levels
8.5.2.1 General
8.5.2.2 Hazard identification and determination
of acceptable levels
ISO 22000 HACCP Application – CODEX Reference
CODEX General Principles of Food Hygiene
are listed in ISO 22000 Bibliography
HACCP Principles
HACCP stands for Hazard Analysis and Critical Control Point. It was
developed by the Codex Alimentarius Commission. HACCP is a system used
to identify, prevent, and control food safety hazards.
The HACCP system and guidelines for its application are defined by the
Codex Alimentarius Commission in the CODEX Recommended International
Code of Practice General Principles of Food Hygiene CXC 1-1969 last
amended in 2022.
HACCP Application – CODEX Section 19
Refer to CODEX
Recommended International
Code of Practice General
Principles of Food Hygiene
Section 19 for more
information
HACCP Application vs. ISO 22000:2018 Relevant Clauses
Step CODEX HACCP Application CODEX Principles ISO 22000:2018
2022 2022 Relevant Clauses
Step 1 19.1 Assemble HACCP Team and Identify Scope (Step 1) 5.3 Food safety team
19.2 Describe product (Step 2) 8.5.1.2 Characteristics of raw materials, ingredients and
Step 2 product-contact materials
Step 3 19.3 Identify intended use and users (Step 3) 8.5.1.4 Intended use
Step 4 19.4 Construct flow diagram (Step 4) 8.5.1.5 Flow diagrams and descriptions of processes
Step 5 19.5 On-site confirmation of flow diagram (Step 5)
19.6 List all potential hazards that are likely to occur and Principle 1 8.5.2 Hazard analysis
associated with each step, conduct a hazard analysis to Conduct a hazard analysis and identify control measures 8.5.3 Validation of control measure(s) and combinations of
Step 6
identify the significant hazards, and consider any measures control measure(s)
to control identified hazards (Step 6/ Principle 1)
19.7 Determine the Critical Control Points (Step 7/ Principle Principle 2 8.5.4 Hazard control plan
Step 7
2) Determine the Critical Control Points (CCPs).
19.8 Establish validated critical limits for each CCP (Step 8/ Principle 3 8.5.4 Hazard control plan
Step 8 Principle 3) Establish validated critical limits. 8.5.3 Validation of control measure(s) and combinations of
control measure(s)
19.9 Establish a Monitoring System for Each CCP (Step 9/ Principle 4 8.5.4.3 Monitoring systems at CCPs and for OPRPs
Step 9
Principle 4) Establish a system to monitor control of CCPs.
19.10 Establish corrective actions (Step 10/ Principle 5) Principle 5 8.5.4 Hazard control plan 8.9.2 Corrections
Establish the corrective actions to be taken when 8.9.3 Corrective actions
Step 10
monitoring indicates a deviation from a critical limit at a
CCP has occurred.
19.11 Validation of the HACCP Plan and Verification Principle 6 8.5.3 Validation of control measure(s) and combinations of
Procedures (Step 11/ Principle 6) Validate the HACCP plan and then establish procedures for control measure(s)
Step 11 19.11.1 Validation of the HACCP Plan verification to confirm that the HACCP system is working as 8.7 Control of monitoring and measuring
19.11.2 Verification Procedures intended. 8.8 Verification related to PRPs and the hazard control plan
9.2 Internal Audit
19.12 Establish Documentation and Record Keeping (Step Principle 7 7.5 Documented information
12/ Principle 7) Establish documentation concerning all procedures and
Step 12
records appropriate to these principles and their
application.
7 Principles of a HACCP System
The HACCP system, which is science-based and systematic, identifies
specific hazards and measures for their control to ensure the safety of
food. HACCP is a tool to assess hazards and establish control systems
that focus on control measures for significant hazards along the food
chain, rather than relying mainly on end-product testing.
The HACCP system is designed, validated and implemented in

accordance with the following seven principles which are shown in the
next 7 slides.
PRINCIPLE 1
Conduct a hazard
analysis and
identify control
PRINCIPLE 7
measures.
PRINCIPLE 2
PRINCIPLE 1
Conduct a hazard
CODEX HACCP 2022
HAZARD ANALYSIS AND
CRITICAL CONTROL
analysis and identify
POINT (HACCP) SYSTEM
PRINCIPLE 6
AND GUIDELINES FOR ITS
APPLICATION PRINCIPLE 3 control measures.
PRINCIPLE 5 PRINCIPLE 4
PRINCIPLE 1
Determine the
PRINCIPLE 7
Critical Control Determine the
Points (CCPs).
CODEX HACCP 2022
HAZARD ANALYSIS AND
Critical Control Points
CRITICAL CONTROL
(CCPs).
APPLICATION
PRINCIPLE 1
PRINCIPLE 7 PRINCIPLE 2 PRINCIPLE 3

CODEX HACCP 2022
Establish validated
HAZARD ANALYSIS AND
CRITICAL CONTROL
POINT (HACCP) SYSTEM PRINCIPLE 3
critical limits.
AND GUIDELINES FOR ITS Establish
PRINCIPLE 6
APPLICATION
validated critical
limits.
PRINCIPLE 1
PRINCIPLE 4
CODEX HACCP 2022
HAZARD ANALYSIS AND
Establish a system to
CRITICAL CONTROL
POINT (HACCP) SYSTEM monitor control of
PRINCIPLE 6
APPLICATION PRINCIPLE 3
CCPs.
PRINCIPLE 4
PRINCIPLE 5 Establish a system
to monitor control
of CCPs.
PRINCIPLE 1
PRINCIPLE 5
Establish the
corrective actions to
CODEX HACCP 2022
HAZARD ANALYSIS AND
CRITICAL CONTROL
be taken when
PRINCIPLE 6
monitoring indicates
PRINCIPLE 5 a deviation from a
Establish the
corrective actions to
be taken when PRINCIPLE 4
critical limit at a CCP
monitoring indicates
a deviation from a
critical limit at a CCP
has occurred.
has occurred.
PRINCIPLE 6
PRINCIPLE 1
Validate the HACCP

plan and then
PRINCIPLE 6
CODEX HACCP 2022
HAZARD ANALYSIS AND
establish procedures
CRITICAL CONTROL
Validate the HACCP
plan and then
establish procedures
POINT
AND
(HACCP) SYSTEM
GUIDELINES FOR ITS
for verification to
PRINCIPLE 3
APPLICATION
for verification to
confirm that the
HACCP system is
confirm that the
working as intended.
HACCP system is
working as intended.
PRINCIPLE 7
PRINCIPLE 7
Establish
documentation
PRINCIPLE 1
Establish
concerning all
procedures and
PRINCIPLE 2
documentation
records appropriate
to these principles
and their applicationCODEX HACCP 2022
HAZARD ANALYSIS AND
concerning all
CRITICAL CONTROL
procedures and
PRINCIPLE 6
records appropriate
to these principles
and their application
ISO 22000 Implementation
Hazard Analysis
Food Safety Hazards can be identified and recorded based on:

✓ Experience (Food Safety Team knowledge)
✓ External and Internal Information such as scientific information epidemiological
studies and other historical information relating to the product food safety
✓ Information from the food chain on food safety hazards related to the safety of
the end products, intermediate products and the food at the time of consumption
✓ Statutory, regulatory and customer requirements.
✓ Customer complaints
✓ Previous internal non conformances
HACCP – CODEX PRINCIPLE 1
Conduct a hazard analysis
Biological hazards are living organisms that can make food
unsafe to eat. Biological hazards may be bacterial, parasitical,
or viral.
Chemical hazards may be the result of something naturally
occurring in ingredients or food or accidentally added during
the process. Harmful chemicals have been associated with both
acute and chronic illness.
A Physical hazard is a physical component of a food that is
unexpected and may cause illness or injury to the person
consuming the food.
Food safety hazards also include Allergens and Radiological

substances
HACCP PRINCIPLE 1
Conduct a Hazard Analysis
ISO 22000 Clause 8.5.2.2.2
The organization shall identify step(s) (e.g. receiving raw materials, processing,
distribution and delivery) at which each food safety hazard can be present, be
introduced, increase or persist.
When identifying hazards, the organization shall consider:
a) the stages preceding and following in the food chain;
b) all steps in the flow diagram;
c) the process equipment, utilities/services, process environment and persons.
Preliminary Hazard List
For each Food Safety Hazard Identified, the acceptable level of the hazard in the end
product is determined, justified and recorded taking into account regulatory and
statutory requirements, customer food safety requirements, historic information,
scientific literature, professional experience, intended use of end products and other
relevant information.
This hazard list is referred to as a Preliminary Hazard List and covers all hazards that
could potentially occur in the product.
Each potential food safety hazard is risk assessed to determine whether its
elimination or reduction to acceptable levels is required to produce a safe product
and also any controls required to achieve the acceptable levels.
For each step grades of impact (the severity of its adverse health effects in relation
to the intended use) and probability (the likelihood of its occurrence in the end
product prior to application of control measures) are allotted and the combined
matrix used to judge the significance and priority for elimination or minimisation of
the hazard.
Likelihood
Not Likely Possible Highly Likely
S
e
Not Severe 1 2 3
v
e
r
Possible Illness 2 4 6
i
t
y Severe Illness 3 6 9
ISO 22000 Implementation 8.5.2.3 Hazard assessment
3 x 3 Hazard Risk Assessment
Severity of adverse health effects x
Likelihood of a food safety hazard
occurring
Likelihood
Not Likely Possible Highly Likely
S
e
Not Severe 1 2 3
v
e
r
Possible Illness 2 4 6
i
t
y Severe Illness 3 6 9
ISO 22000 Implementation Hazard Assessment
The food safety team assess the food safety hazards
First, the Food Safety Team assess the likelihood of the hazard
Significance
Probability
Severity
occurring: Step
Step Name Hazards Identified
Number
1 for Highly Unlikely 1 Delivery of Ingredient A Bone 1 3 3
2 for Possible 1
1
Delivery of Ingredient A Campylobacter spp.
Delivery of Ingredient A Contamination with Bacteria from pests
2
3
3
3
6
9
3 for Likely 1
1
Delivery of Ingredient A Pesticides
Delivery of Ingredient A Salmonella spp. (S. typhimurium, S. enteriditis)
3
3
1
3
3
9
1 Delivery of Ingredient A Bacteria (spore-forming) General 2 2 4
1 Delivery of Ingredient A Pest control chemicals 1 1 1
Then, the Food Safety Team assesses the severity of the hazard:
1 for Not Severe
2 for Could possibly cause illness
3 for Severe (Could be fatal)
ISO 22000 Implementation Hazard Assessment
The Food Safety team factor in the vulnerability of the targeted consumer, the
survival and multiplication of any biological hazards and any likely toxin production,
the presence of chemicals or foreign bodies, contamination at any stage in the
process and possible deliberate contamination or adulteration to the severity score to
determine all the Significant Food Safety Hazards.
In this example the food safety hazards that score a 9 are regarded as significant and
form the Significant Food Safety Hazard List.
Significance
Probability
Severity
Step
Step Name Hazards Identified
Number
1 Delivery of Ingredient A Bone 1 3 3

1 Delivery of Ingredient A Campylobacter spp. 2 3 6
1 Delivery of Ingredient A Contamination with Bacteria from pests 3 3 9
1 Delivery of Ingredient A Pesticides 3 1 3
1 Delivery of Ingredient A Salmonella spp. (S. typhimurium, S. enteriditis) 3 3 9
1 Delivery of Ingredient A Bacteria (spore-forming) General 2 2 4
1 Delivery of Ingredient A Pest control chemicals 1 1 1
The HACCP team must then consider what control measures, if any, exist which can be
applied for each hazard. More than one control measure may be required to control a
specific hazard(s) and more than one hazard may be controlled by a specified control
measure.
Selection and categorization of control measure(s)
For significant hazards decide what control measures are in place for the hazard.
8.5.2 Hazard Analysis
When developing your hazard analysis it is important to keep supporting documentation such as
regulations, scientific papers, study, or in-plant study, and historical information about the
process for the decisions reached by the team.
When applying HACCP to a given operation, consideration should be given to steps preceding and
following the specified operation.
When applying HACCP to a given operation, consideration should be given to steps preceding and
following the specified operation.
This will help you with a due diligence defence in demonstrating how you have conducted your
hazard analysis.
Remember to list the actual hazard or organism rather than just a general hazard whenever
possible.
ISO 22000 Implementation Assessing Control Measures
Using a systematic approach the Food Safety Team categorise the selected identified
control measures to be managed as OPRPs or at CCPs.
For Significant Hazards scoring

9 proceed to Assessment of
Control Measures
Selection and Categorisation of Control Measures
8.5.2.4.1 For each of the control measures selected, there needs to be an assessment of:
a) the likelihood of failure of its functioning
b) the severity of the consequence in the case of failure of its functioning
b) (1) including the effect on identified significant food safety hazards
b) (2) including the location in relation to other control measures
b) (3) including whether it is specifically established and applied to reduce the hazards to an
acceptable level
b) (4) including whether it is a single measure or is part of combination of control measures
8.5.2.4.2 For each of the control measures selected, there needs to be an assessment of:
a) the feasibility of establishing measurable critical limits and/or measurable/observable action
criteria
b) the feasibility of monitoring to detect any failure to remain within critical limit and/or
measurable/observable action criteria
c) the feasibility of applying timely corrections in case of failure
Selection and Categorisation of Control Measures
Selection and categorization of control measures includes the following assessments in the Hazard
Analysis Calculator worksheet:
The Control Measure Assessment section of the Hazard Analysis Calculator is Colour Coded.
Control Measures that are Not likely to be Effective are highlighted by a Black Box.
Control Measures that are likely to be PRPs are highlighted by a Green Box.
Control Measures that are likely to be Operational PRPs are highlighted by a Orange Box.
If all Boxes are Red after Assessment the team are to continue and use the Decision Tree Section.
If a mixture of Red and Orange Boxes are highlighted then the HACCP team consider if to proceed to the
Decision Tree Section or implement as an Operational PRP.
Significant Hazards which proceed to the Decision Tree Section are Categorised as Critical Control Points
if they are highlighted in Red by the Hazard Analysis Calculator otherwise they are implemented as
Operational PRPs.
Document Reference FSSC 22000 HACCP Calculator Instructions

Revision 2 2023
Written by: Tony-C
Selection and Categorization of Control Measures
a) What is the likelihood of failure

of its functioning?
Consider if:
Never fails
Slight risk of failure
Possible failure
Likely failure
Guaranteed failure
b) What is the severity of the

consequences in the case of failure
in its functioning?
Consider would failure mean a:
Very severe life-threatening event
Severe injury or trauma requiring
urgent hospital treatment
Immobilising injury or trauma
requiring hospital treatment
Non-immobilising injury or trauma
but requiring hospital treatment
Minor non-immobilising injury or
trauma not requiring hospital
treatment
b) (1) What is the effect on identified

significant food safety hazards?
Eliminates the hazard

Significant reduction
Some reduction
Little effect
Based on the above select from the

drop-down list if it is likely to be a CCP,
OPRP, PRP or Not Effective.
If Not Effective Modify or look for a

different Control Measure
b) (2) What is the location in

relation to other control
measures?
At the end of the process

Near the end of the process
Mid process
Start of process
b) (3) Is the Control Measure

specifically established to reduce
the hazards to an acceptable
level?
Specifically designed to Control

the Hazard
Not specific but Effective
Not specific partly effective
Not specific not effective
b) (4) Is the control measure a single

measure or is part of combination of
control measures?
Single Measure and Effective

Combination and Effective in
Combination
Single Measure not Effective
Combination not Effective in
Combination
Feasibility a) What is the feasibility of

establishing measurable critical limits
and/or measurable/observable action
criteria?
Likely to be able to establish measurable
critical limits
Likely to be able to establish
Not likely to establish measurable critical
limits
Not likely to establish
Not likely to establish establish measurable
critical limits or measurable/observable
action criteria
Feasibility b) What is the feasibility of

monitoring to detect any failure to
remain within critical limit and/or
measurable/observable action criteria?
Can be monitored to detect any failure

100% of the time
Good proportion of product monitored
Some monitoring
Very little monitoring
Feasibility c) What is the feasibility

of applying timely corrections in
case of failure?
Timely corrections can be applied

100% of the time
most of the time
some of the time
Timely corrections can’t be applied
Make notes of your findings from

Assessment of Control Measures
Complete the Hazard Assessment using

the Decision Tree
FSSC 22000 HACCP Calculator Instructions
You are now ready to complete the Hazard

Analysis Calculator Decision Tree Section
* Consider the significance of the hazard (i.e., the likelihood of

occurrence in the absence of control and the severity of impact
of the hazard) and whether it could be sufficiently controlled by
prerequisite programs such as GHPs. GHPs could be routine GHPs
or GHPs that require greater attention to control the hazard (e.g.
monitoring and recording).
** If a CCP is not identified at questions 2-4, the process or
product should be modified to implement a control measure and
a new hazard analysis should be conducted.
***Consider whether the control measure at this step works in
combination with a control measure at another step to control
the same hazard, in which case both steps should be considered
as CCPs.
****Return to the beginning of the decision tree after a new
hazard analysis.

Revision 2 2023
Written by: Tony-C
You are now ready to complete the Hazard

Analysis Calculator Decision Tree Section
* Consider the significance of the hazard (i.e., the likelihood of

occurrence in the absence of control and the severity of impact
of the hazard) and whether it could be sufficiently controlled by
prerequisite programs such as GHPs. GHPs could be routine GHPs
or GHPs that require greater attention to control the hazard (e.g.
monitoring and recording).
** If a CCP is not identified at questions 2-4, the process or
product should be modified to implement a control measure and
a new hazard analysis should be conducted.
***Consider whether the control measure at this step works in
combination with a control measure at another step to control
the same hazard, in which case both steps should be considered
as CCPs.
****Return to the beginning of the decision tree after a new
hazard analysis.

Revision 2 2023
Written by: Tony-C
Question 1
Can the significant hazard be controlled This step is not a Critical
to an acceptable level at this step by Control Point (CCP)
prerequisite programs (e.g. GHPs) *?
No
Question 2 This step is not a Critical If a CCP is not identified at questions

2-4, the process or product should be
Do specific control measures for an Control Point (CCP). modified to implement a control
identified significant hazard exist at this Subsequent steps should measure and a new hazard analysis
step? should be conducted.
be evaluated for a CCP.
Yes
Question 3
Will a subsequent step prevent or
This step is not a Critical The subsequent step
eliminate the identified significant
hazard or reduce it to an acceptable Control Point (CCP). should be a CCP.
level?
No
Question 4 This step is not a Critical
Can this step specifically prevent or Control Point (CCP). Return to the beginning of the
eliminate the identified significant Modify the step, process or decision tree after a new hazard
hazard or reduce it to an acceptable product to implement a analysis.
level? *** control measure.
Yes
This step is a Critical

Control Point (CCP)
CODEX CCP Decision Tree 2022
Question 1: Can the significant hazard be
controlled to an acceptable level at this
step by prerequisite programs (e.g.
GHPs)*?
Enter Y for Yes or N for No
Do not leave blank
Stop at this point if the cell turns Orange.
This step is not a CCP.
If No, the cell turns Green. Proceed to
Question 2.

Revision 2 2023
Written by: Tony-C
Question 2: Do specific control measures for an
identified significant hazard exist at this step?
Do not leave blank
Stop at this point if the cell turns Orange.
This step is not a CCP.
Subsequent steps should be evaluated for a CCP**.
If Yes, the cell turns Green. Proceed to Question 3.

Revision 2 2023
Written by: Tony-C
Question 3: Will a subsequent step
prevent or eliminate the identified
significant hazard or reduce it to an
acceptable level?
Do not leave blank
If yes, the cell turns light red.
That subsequent step should be a CCP.
If No, the cell turns green. Proceed to
Question 4.

Revision 2 2023
Written by: Tony-C
Question 4: Can this step specifically
prevent or eliminate the identified
significant hazard or reduce it to an
acceptable level? ***
Do not leave blank
If No, the cell turns yellow.
Modify the step, process or product to
implement a control measure ****
If Yes, the cell turns dark red.
*** Consider whether the control measure
This step is a Critical Control Point (CCP) . at this step works in combination with a
control measure at another step to control
the same hazard, in which case both steps
should be considered as CCPs.
****Return to the beginning of the decision
tree after a new hazard analysis.

Revision 2 2023
Written by: Tony-C
FSSC 22000 HACCP Calculator - HACCP Decision Tree
*** Consider whether the control measure at this step works in combination with a
control measure at another step to control the same hazard, in which case both steps
should be considered as CCPs.

Revision 2 2023
Written by: Tony-C
Confirm your decisions if Control
Measures are to be implemented as
CCP, OPRP or PRPs by ticking the
appropriate box.

Revision 2 2023
Written by: Tony-C
appropriate box.
CODEX Table 1: Example of a CCP determination worksheet
appropriate box.
ISO 22000: 8.5.3 Validation of control measure(s) and
combinations of control measures
The food safety team need to validate that the selected
control measures are capable of achieving the intended
control of the significant food safety hazards.
Validation must be completed prior to implementation of
control measures and combinations of control measures to
be included in the hazard control plan.
When the result of validation shows that a control measures
is not capable of achieving the intended control, the food
safety team need to modify and re-assess the control
measures and/or combination of control measures.
The food safety team should document the validation
methodology and evidence of capability of the control
measures to achieve the intended control.
Validation
Supporting validation documentation can consist of information from:
✓ Regulatory limits or Industry Code of Practice Guidelines

✓ Scientific journals
✓ Documented challenge studies
✓ In-house data
8.5.3 Validation of control measure(s)
8.5.4 Hazard control plan (HACCP/OPRP plan)

8.5.4.1 General
8.5.4.2 Determination of critical limits and action criteria
ISO 22000 8.5.4 Hazard control plan (HACCP/OPRP plan)
The hazard control plan needs to include for each control measure at each
CCP or OPRP:
✓ Food safety hazard(s) to be controlled at the CCP or by the OPRP
✓ Critical limit(s) at CCP or action criteria for OPRP
✓ Monitoring procedure(s)
✓ Correction(s) to be made if critical limits or action criteria are not met;
✓ Responsibilities and authorities
✓ Records of monitoring
Critical Control Points (CCPs)/OPRPs
Many control measures are commonly applied in food processing and production to control
significant hazards including:
✓ Chilling or Freezing to temperatures that minimize microbial growth
✓ Cooking to specific temperatures for exact times in order to destroy microbial pathogens
✓ Product Acidification such as the addition of cultures or chemicals to reduce pH
✓ Product Drying or water reduction to remove available water
✓ Processes such as sealing
✓ Addition of Preservatives to prevent microbial growth
✓ Metal Detection
✓ Filtration
HACCP PRINCIPLE 3 Establish Critical Limit(s)
A critical limit is the maximum or minimum

value to which a physical, biological, or
chemical hazard must be controlled at a
critical control point to prevent, eliminate, or
reduce to an acceptable level the occurrence
of the identified food safety hazard.
ISO 22000 Clause 8.5.4.2 Determination of critical
limits and action criteria
ISO 22000 requires that as well as Critical Limits at CCPs that Action criteria for
Operational Prerequisite Programmes need to be specified. The rationale for
their determination shall be maintained as documented information.
Action criteria for OPRPs shall be measurable or observable. Conformance
with action criteria shall contribute to the assurance that the acceptable level
is not exceeded.
When monitoring an OPRP is based on subjective data from observations (e.g.
visual inspection), the method shall be supported by instructions or
specifications.
ISO 22000 Clause 8.5.4.3 Monitoring systems at CCPs and for OPRPs
Monitoring should ideally provide information in time to make

adjustments to ensure control of the process.
Where possible, process adjustments should be made when monitoring
results indicate a trend towards loss of control at a CCP or OPRP.
ISO 22000 Clause 8.5.4.4
Actions when critical limits or action criteria are not met
PRINCIPLE 5 Establish the corrective actions to be taken when monitoring indicates a
deviation from a critical limit at a CCP has occurred.
The corrective action planned needs ensure:

✓ the cause of the deviation has been identified and eliminated
✓ the CCP reverts to a controlled state after the corrective action has been taken
✓ measures to prevent recurrence of the deviation have been established
✓ product is quarantined until it is established that it is safe.
The organization shall implement and maintain the hazard

control plan, and retain evidence of the implementation as
documented information.
Hazard Control Plan (CCP/OPRP Plan)
Hazard Control Plans should include:

Process Step
Hazard
Control Measure
Action Criteria/Critical Limits
Monitoring Procedures
Corrections/Corrective Action
Responsibilities
Reference to relevant Records
Hazard Control Procedure
Hazard Control Record
8.6 Updating the information specifying the PRPs and the
hazard control plan
Following the establishment of the hazard control plan,
the Food Safety Team update the following, if necessary:
✓ Characteristics of raw materials, ingredients, product-

contact materials and end products
✓ Intended use
✓ Flow diagrams
✓ Descriptions of processes and process environment

8.8.1 Verification
8.9.1 General
8.8.1 Verification
Verification activities shall confirm that

a) the PRP(s) are implemented and effective;
b) the hazard control plan is implemented and effective
Prerequisite Programme Verification
Records generated from prerequisite programs should be reviewed by

the establishment.
Records generated from prerequisite programs should be monitored by
inspection personnel.
A non-compliance exists if insanitary conditions are created and a Food
Safety Hazard is created.
Repeated failures may indicate that decisions made in the Hazard
Analysis are not supported.
Documentation should verify proper implementation of Prerequisite
Programmes.
Verification records PRPs and the hazard control plan need to be

reviewed.
The food safety team shall conduct an analysis of the results of
verification that shall be used as an input to the performance evaluation
of the FSMS (see 9.1.2).
Corrective Action Form
Corrective Action
Request
Completed
Example
ISO 22000 Section 9 Performance evaluation
Section 9 includes requirements for:
9.1 Monitoring, measurement, analysis and evaluation

9.1.1 General
9.1.2 Analysis and evaluation
9.2 Internal audit
9.2.1 The organization shall conduct internal audits at planned
intervals to provide information on whether the FSMS:
a) conforms to:
1) the organization’s own requirements for its FSMS;
2) the requirements of the standard;
b) is effectively implemented and maintained.
9.2.2 The organization shall:

e) retain documented information as evidence of the
implementation of the audit programme and the audit results;
9.2 Internal audit
9.2 Internal audit
ISO 22000 Section 9 9.3 Management review
Section 9 Performance evaluation:
9.3 Management review

9.3.1 General
9.3.2 Management review input
9.3.3 Management review output
ISO 22000 Section 9 9.3 Management review
ISO 22000 Section 10 Improvement
Section 10 Improvement includes requirements for:
10.1 Nonconformity and corrective action

10.2 Continual improvement
10.3 Update of the food safety management system
FSSC 22000 Version 6 Additional Requirements
2) sector specific prerequisite program (PRPs) requirements*
(ISO/TS 22002-x series or other specified PRP standard) and;
* The Scheme specifies mandatory application of technical

specifications detailing the pre-requisite programs (PRPs) as
referenced in clause 8.2 of ISO 22000:2018, with the exception of
sub-category FII. Food chain category FII applies to Food brokering,
trading, and E-commerce activities.
2.5 FSSC 22000 Additional Requirements
The following specific additional FSSC requirements for the food safety management
system are included in the Scheme (All Food Chain Categories) unless stated:
2.5.1 Management of Services and Purchased Materials
2.5.2 Product Labelling and Printed Materials
2.5.3 Food Defense
2.5.4 Food Fraud Mitigation
2.5.5 Logo Use
2.5.6 Management of Allergens
2.5.7 Environmental Monitoring (Food Chain Categories BIII, C, I & K)
2.5.8 Food Safety and Quality Culture
2.5.9 Quality Control
2.5.10 Transport, Storage and Warehousing
2.5 FSSC 22000 Additional Requirements
The following additional FSSC requirements for the food safety management system
are included in the Scheme (all Food Chain Categories) unless stated:
2.5.11 Hazard Control and Measures for Preventing Cross-contamination (All
excluding FII)
2.5.12 PRP Verification (Food Chain Categories BIII, C, D, G, I & K)
2.5.13 Product Design and Development (Food Chain Categories BIII, C, D, E, F, I & K)
2.5.14 Health Status (Food Chain Category D)
2.5.15 Equipment Management (All excluding FII)
2.5.16 Food Loss and Waste (All excluding I)
2.5.17 Communication Requirements
2.5.18 Requirements for Organization with Multi-Site Certification (Food Chain
Categories A, E, F & G)
In addition to clause 7.1.6 of ISO 22000:2018, the organization
shall ensure that where laboratory analysis services are used for
the verification and/or validation of food safety, these shall be
conducted by a competent laboratory (including both internal and
external laboratories as applicable) … using validated test
methods and best practices …...
(e.g. successful participation in proficiency testing programs,
regulatory approved programs or accreditation to international
standards such as ISO 17025).
Laboratory Manual compliant with ISO/IEC 17025
ISO/IEC 17025 is an ISO standard for General Requirements
for the Competence of Testing and Calibration Laboratories.
ISO/IEC 17025 enables laboratories to demonstrate that they
operate competently and generate valid results.
ISO/IEC 17025 is an ISO standard for General Requirements
for the Competence of Testing and Calibration Laboratories.
ISO/IEC 17025 enables laboratories to demonstrate that they
operate competently and generate valid results.
Management of Services and Purchased Materials
ISO 22000:2018 7.1.6 Control of externally provided processes, products or services
requires organisations to:
a) establish and apply criteria for the evaluation, selection, monitoring of
performance and re- evaluation of external providers of processes, products and/or
services;
b) ensure adequate communication of requirements to the external provider(s);
c) ensure that externally provided processes, products or services do not adversely
affect the organization's ability to consistently meet the requirements of the FSMS;
d) retain documented information of these activities and any necessary actions as a
result of the evaluations and re-evaluations.
In addition to clause 7.1.6 of ISO 22000:2018, the organization needs
to have a documented procedure for procurement in emergency
situations to ensure that products still conform to specified
requirements and the supplier has been evaluated.
In addition to ISO/TS 22002-1:2009 clause 9.2, Selection and

management of suppliers, where applicable the organization shall
have a policy for the procurement of animals, fish and seafood that
are subject to control of prohibited substances such as veterinary
medicines and pesticides.
For food chain categories C, D, I, G and K, the following additional requirement
applies: The organization shall establish, implement, and maintain a review process
for product specifications to ensure continued compliance with food safety, legal and
customer requirements.
A compliant FSSC 22000 Food Safety Management System needs to include
documentation for managing the process of purchasing materials and services
including supplier assessment, approval and monitoring.
A compliant FSSC 22000 Food Safety Management System needs to include documentation
for managing Purchasing Materials and Services.
In addition to clause 8.5.1.3* of ISO 22000:2018, the organization shall ensure
that finished products are labelled according to all applicable food safety
(including allergens and customer specific requirements) statutory and
regulatory requirements in the country of intended sale.
ISO 22000:2018 8.5.1.3 * Characteristics of end products
Where product is unlabelled, all relevant product information shall be made
available to ensure the safe use of the food by the customer or consumer.
Where a claim (e.g. allergen, nutritional, method of production, chain of
custody, raw material status, etc.) is made on the product label or packaging,
the organization shall maintain evidence of validation to support the claim and
shall have verification systems in place, including traceability and mass balance,
to ensure product integrity is maintained.
Verification Systems including Traceability and Mass Balance
2.5.3 Food Defense
Threat Assessment
a) Conduct and document a food defense threat assessment, based
on a defined methodology, to identify and evaluate potential threats
linked to the processes and products within the scope of the
organization; and
b) Develop and implement appropriate mitigation measures for
significant threats.
2.5.3 Food Defense
2.5.3 Food Defense
2.5.3 Food Defense
Plan
a) The organization shall have a documented food defense plan,
based on the threat assessment, specifying the mitigation measures
and verification procedures.
b) The food defense plan shall be implemented and supported by the
organization’s FSMS.
c) The plan shall comply with applicable legislation, cover the
processes and products within the scope of the organization and be
kept up to date.
2.5.3 Food Defense
2.5.4 Food Fraud Mitigation
Vulnerability assessment
a) Conduct and document the food fraud vulnerability assessment,

based on a defined methodology
b) Develop and implement appropriate mitigation measures for
significant vulnerabilities.
Food Fraud Mitigation
Plan
a) The organization shall have a documented food fraud mitigation

plan, based on the output of the vulnerability assessment,
b) The food fraud mitigation plan shall be implemented and
supported
c) The plan shall comply with the applicable legislation, cover the
processes and products within the scope of the organization and be
kept up to date.
2.5.5 Logo Use
Certified organizations are entitled to use the FSSC 22000 logo

for marketing activities.
The FSSC 22000 logo may be used on the organization’s

printed matter, website and other promotional material but is
subject to prescribed design specifications.
There are specified restrictions where the logo cannot be used

such as on product, labels, packaging, COAs & COCs.
The organization shall have a documented allergen management plan that includes:
a) A list of all the allergens handled on site, including in raw materials and finished
products
b) Risk assessment covering all potential sources of allergen cross-contamination
c) Identification and implementation of control measures to reduce or eliminate the
risk of cross-contamination …
d) Validation and verification of these control measures
Allergen Management – Validation & Verification of Cleaning
Performance
Verification Monitoring method:

ATP Swab after cleaning before Start Up
Validation/Verification Monitoring method
Action Limits:
10 – 20 rlu – Sanitise and Re-Swab
> 20 rlu – Full Clean and Re-Swab
The organization shall have a documented allergen management plan that includes:
e) Precautionary or warning labels shall only be used where the outcome of the risk
assessment identifies allergen cross-contamination as a risk to the consumer, even
though all the necessary control measures have been effectively implemented.
f) All personnel shall receive training in allergen awareness and specific training on
allergen control measures associated with their area of work
g) The allergen management plan shall be reviewed at least annually, and following any
significant change that impacts food safety, a public recall or a product withdrawal by
the organization as a result of an allergen/s, or when trends in industry show
contamination of similar products relating to allergens.
2.5.7 Environmental Monitoring (Categories BIII, C, I & K )
The organization shall have in place:
a) Risk-based environmental monitoring program for the relevant pathogens,
spoilage, and indicator organisms;
b) Documented procedure for the evaluation of the effectiveness of all
controls on preventing contamination from the manufacturing environment
and this shall include, at a minimum, the evaluation of microbiological
controls present and comply with legal and customer requirements.
c) Data of the environmental monitoring activities including regular trend
analysis.
2.5.7 Environmental Monitoring (Categories BIII, C, I & K )
2.57 Environmental Monitoring
2.5.7 Environmental Monitoring
d) The environmental monitoring program shall be reviewed for continued
effectiveness and suitability, at least annually, and more often if required,
including when the following triggers occur:
i. Significant changes related to products, processes, or legislation;
ii. When no positive testing results have been obtained over an extended
period of time;
iii. Trend in out of specification microbiological results, related to both
intermediate and finished products, linked to environmental monitoring;
iv. A repeat detection of pathogens during routine environmental monitoring;
and
v. When there are alerts, recalls or withdrawals relating to product/s
produced by the organization.
2.57 Environmental Monitoring
a) In accordance with and in addition to clause 5.1 of ISO 22000:2018, as part of
the organizations’ commitment to cultivating a positive food safety and quality
culture, senior management shall establish, implement and maintain a food
safety and quality culture objective(s) as part of the management system.
The following elements shall be addressed as a minimum:
Communication, Training, Employee feedback and engagement, and Performance
measurement of defined activities covering all sections of the organization
impacting on food safety and quality.
ISO 22000:2018 clause 5.1 Leadership and Commitment

Top management shall demonstrate leadership and commitment with respect to
the FSMS by:
a) ensuring that the food safety policy and the objectives of the FSMS are
established and etc.
b) – h) …..
Senior
Management
Monitoring & Policies &

Feedback Standards
Food Safety
Visible
Culture
Communication
Support
Education/
Resources
Training
a) In accordance with and in addition to clause 5.1 of ISO 22000:2018, as part of
the organizations’ commitment to cultivating a positive food safety and quality
culture, senior management shall establish, implement and maintain a food
safety and quality culture objective(s) as part of the management system.
The following elements shall be addressed as a minimum:
Communication, Training, Employee feedback and engagement, and Performance
measurement of defined activities covering all sections of the organization
impacting on food safety and quality.
The FSSC 22000 Food Safety Management System Implementation
Package includes documentation for developing and managing a
Food Safety and Quality Culture also covering these additional
requirements in documents:
FSMS 5.1 Leadership and commitment
FSMS 5.1 Food Safety Culture Planning
FSMS 5.1 FS Culture - Expected Behaviours
FSMS 6.2 Food Safety & Quality Objectives
b) The objective(s) shall be supported by a documented food safety and quality
culture plan, with targets and timelines and included in the management review
and continuous improvement processes of the management system.
2.5.9 Quality Control (All Food Chain Categories)
a) The organization shall:
i. In addition to, and aligned with, clauses 5.2 and 6.2 of ISO 22000:2018, establish,
implement and maintain a quality policy and quality objectives.
ii. Establish, implement and maintain quality parameters in line with finished
product specifications, for all products and/or product groups within the scope of
certification, including product release that addresses quality control and testing.
iii. In addition to, and aligned with, clauses 9.1 and 9.3 of ISO 22000:2018, undertake
analysis and evaluation of the results of the quality control parameters, as
defined above, and include it as an input for the management review; and
iv. In addition to, and aligned with, clause 9.2 of ISO 22000:2018, include quality
elements as defined in this clause, within the scope of the internal audit.
Package includes documentation for managing quality also covering
these additional requirements in documents:
FSMS 5.2 Food Safety & Quality Policy
Product Specifications
FSMS 9.2 Internal Audits & Inspections
ISO 22000 and ISO 22002 Audit Plan with Risk Rating
FSMS 5.2 Food Safety & Quality Policy
Product Specifications
ISO 22000 and ISO 22002 Audit Plan with Risk Rating
b) Quantity control procedures, including for unit, weight, and volume, shall be
established, and implemented, to ensure products meet the applicable customer and
legal requirements. This shall include a program for calibration and verification of
equipment used for quality and quantity control.
c) Line start-up and change-over procedures shall be established and implemented to

ensure products, including packaging and labelling, meet applicable customer and
legal requirements. This shall include having controls in place to ensure labelling and
packaging from the previous run have been removed from the line.
FSMS 8.1 Operational planning and control
FSMS 8.7 Control of monitoring and measuring
FSMS 9.1 Monitoring, measurement, analysis and evaluation
PRP 17.2 Product Labelling Controls
FSMS 8.7 Control of monitoring and measuring
FSMS 9.1 Monitoring, measurement, analysis and evaluation
PRP 17.2 Product Labelling Controls
(All Food Chain Categories)
A requirement to establish, implement, and maintain a procedure and
specified stock rotation system that includes FEFO (First Expired, First Out)
principles in conjunction with the FIFO (First In, First Out) requirements.
For food chain category C0, in addition to ISO/TS 22002-1:2009 clause 16.2
Warehousing requirements, where applicable, there needs to specified
requirements in place that define post-slaughter time and temperature for
chilling or freezing of the products.
For food chain category FI Retail /Wholesale/ E-commerce, in addition to
BSI/PAS 221:2013 clause 9.3, the organization shall ensure that product is
transported and delivered under conditions which minimize the potential
for contamination.
The FSSC 22000 Food Safety Management System Implementation Package
includes:
PRP 16.1 Warehousing Prerequisites
PRP 16.2 Warehousing Procedures
PRP 16.3 Dispatch and Distribution Prerequisites
PRP 16.3 Appendix - Dispatch and Distribution Procedure
includes:
PRP 16.1 Warehousing Prerequisites
PRP 16.2 Warehousing Procedures
PRP 16.3 Dispatch and Distribution Prerequisites
PRP 16.3 Appendix - Dispatch and Distribution Procedure
d) Where transport tankers are used, the following shall apply in addition to
clause 8.2.4 of ISO 22000:2018:
i) Organizations that use tankers for transportation of their final product
shall have a documented risk-based plan to address transport tank cleaning.
….
ii) For organizations receiving raw material in tankers, the following shall be
included in the supplier agreement as a minimum to ensure product safety
and prevent cross-contamination: tanker cleaning validation, restrictions
linked to prior use and applicable control measures relevant to the product
being transported.
2.5.11 Hazard Control and Measures for Preventing Cross-
contamination
(ALL FOOD CHAIN CATEGORIES, EXCLUDING FII)
For food chain categories BIII, C and I, Production of food packaging and packaging
materials, there are SPECIFIC requirements for packaging used to impart or provide a
functional effect on food such as shelf life extension.
For food chain category C0, Processing of perishable animal products, in addition to
ISO/TS 22002- 1:2009 10 Measures for prevention of cross-contamination clause 10.1
General requirements there needs to be specified requirements for an inspection process
at lairage and/or at evisceration to ensure animals are fit for human consumption.
For food chain category D Animal Feed Production, the following requirement applies in
addition to ISO/TS 22002- 6:2016 clause 4.7: The organization shall have in place
procedures to manage the use of ingredients/additives that contain nutrients components
that can have an adverse animal health impact.
2.5.11 Hazard Control and Measures for Preventing Cross-
contamination
d) For all food chain categories, excluding FII, the following requirements relating to
foreign matter management apply, in addition to clause 8.2.4 (h) of ISO 22000:2018:
i. The organization shall have a risk assessment in place to determine the need and
type of foreign body detection equipment required. Where the organization
deems no foreign body detection equipment is necessary, justification shall be
maintained as documented information. Foreign body detection equipment
includes equipment such as magnets, metal detectors, X-ray equipment, filters,
and sieves.
ii. A documented procedure shall be in place for the management and use of the
equipment selected.
iii. The organization shall have controls in place for foreign matter management
including procedures for the management of all breakages linked to potential
physical contamination (e.g., metal, ceramic, hard plastic).
2.5.11 Hazard Control and Measures for Preventing
Cross-contamination
Package includes documentation for Hazard Control also covering
FSMS 8.1 Operational Planning and Control
PRP 2 HACCP Prerequisite Programmes
PRP 10.1 Prevention of Contamination
PRP 10.4 Prevention of Physical Contamination
Operational Prerequisite Programmes
Cross-contamination
Cross-contamination
Package includes Operational Prerequisite Programmes to prevent
foreign body contamination
Cross-contamination
Package includes Operational Prerequisite Programmes to prevent
foreign body contamination
2.5.12 PRP Verification
(Food Chain Categories BIII, C, D, G, I & K)
The following additional requirement applies to ISO 22000: 2018 clause 8.8.1*:
There needs to be routine (e.g. monthly) site inspections/PRP checks to verify that
the site (internal and external), production environment and processing equipment
are maintained in a suitable condition to ensure food safety.
The frequency and content of the site inspections/PRP checks based on risk (high
risk and open product areas are normally the priority) with defined sampling
criteria and linked to the relevant technical specification.
ISO 22000 8.8 Verification related to PRPs and the hazard control plan
Clause 8.8.1 Verification:
The FSSC 22000 Food Safety Management System
Implementation Package includes:
FSMS 9.2 Plans & Checklists Folder
PRP Verification Records
Internal Audit & Inspection Training Presentations

2.5.13 Product Design and Development
(Food Chain Categories BIII, C, D, E, F, I & K)
Requirements for a product design and development procedure for new
products and changes to product or manufacturing processes to ensure safe and
legal products are produced including:
✓ Evaluation of the impact of the change taking into account any new food
safety hazards (including allergens)
✓ Resource and training needs
✓ Equipment and maintenance requirements
✓ The need to conduct production and shelf-life trials
✓ On-going shelf-life verification must be in place, at a frequency based on risk.
✓ Where a ready-to-cook product is produced, the cooking instructions
provided on the product label or packaging must be validated to ensure food
safety is maintained.
Package includes:
FSMS 8.1 Product Development Folder – NPD Documents
FSR Product Change Approval Records
Package includes:
Package includes:
Package includes:
2.5.14 Health Status
(Food Chain Category D Production of Animal Feed)
2.5.14 Health Status (Food Chain Category D)

In addition to ISO/TS 22002-6 clause 4.10.1, the organization shall
have a procedure to ensure that the health of personnel does not
have an adverse effect on the feed production operations.
2.5.15 Equipment Management
(All Food Chain Categories, Excluding FII)
In addition to clause 8.2.4 of ISO 22000:2018, the organization shall:
a) Have a documented purchase specification in place, which addresses hygienic
design, applicable legal and customer requirements, and the intended use of the
equipment, including product handled. The supplier shall provide evidence of
meeting the purchase specification prior to installation.
b) Establish and implement a risk-based change management process for new
equipment and/or any changes to existing equipment, which shall be adequately
documented including evidence of successful commissioning. Possible effects on
existing systems shall be assessed and adequate control measures determined and
implemented.
Package includes documentation for managing New Equipment also
covering these additional requirements in documents:
PRP 8.1 Equipment Prerequisite Programmes PRPs
PRP 8.2 Equipment Hygienic Design
FSR Equipment Commissioning Checklist
FSR Process Change Approval
2.5.16 Food Loss and Waste
(All Food Chain Categories, Excluding I)
In addition to clause 8 of ISO 22000:2018, the organization shall:
a) Have a documented policy and objectives detailing the organization’s strategy to
reduce food loss and waste within their organization and the related supply chain.
b) Have controls in place to manage products donated to not-for-profit
organizations, employees, and other organizations; and ensure that these products
are safe to consume.
c) Manage surplus products or by-products intended as animal feed/food to
prevent contamination of these products.
d) These processes shall comply with the applicable legislation, be kept up to date,
and not have a negative impact on food safety.
includes documentation for managing Waste also covering these additional
PRP 7 Waste Management Overview including FLW

PRP 7.1 Waste Management PRPs
PRP 7.5 Management of Surplus Food and Products for Animal Feed
PRP 7 Food Loss and Waste Analysis
FLW Strategies Priority Ranking
1. Reduction at Source – Reduce Total Volume/Weight
2. Food Redistribution – Donations
3. Animal Feed – Food downgrade recovered for animal feed
4. Industrial Uses and Fertilizers
The FSSC 22000 Food Safety Management5.System
Anaerobic Digestion
Implementation Package
6. Composting
7. Landfill – last resort for disposal

PRP 7.5 Management of Surplus Food and Products for Ani

PRP 7.5 Management of Surplus Food and Products for Animal Feed
In addition to clause 8.4.2 of ISO 22000:2018, the organization shall inform the
certification body within 3 working days of the commencement of the events or
situations below and implement suitable measures as part of their emergency
preparedness and response process:
a) Serious events that impact the FSMS, legality and/or the integrity of the
certification including situations that pose a threat to food safety, or certification
integrity as a result of a Force majeure, natural or man-made disasters (e.g., war,
strike, terrorism, crime, flood, earthquake, malicious computer hacking, etc.);
The FSSC 22000 Food Safety Management System Implementation Package includes
comprehensive documentation for Crisis/Incident Management also covering these
additional requirements in documents:
FSMS 7.4 Communication
FSMS 8.4 Emergency preparedness and response
FSMS 8.9.5 Withdrawal/recall
In addition to clause 8.4.2 of ISO 22000:2018, the organization shall inform the
certification body within 3 working days of the commencement of the events or
situations below and implement suitable measures as part of their emergency
preparedness and response process:
b) Serious situations where the integrity of the certification is at risk and/or where
the Foundation can be brought into disrepute. These include, but are not limited to:
Public food safety events (e.g., public recalls, withdrawals, calamities, food safety
outbreaks, etc.)
Actions imposed by regulatory authorities as a result of a food safety issue(s)
where additional monitoring or forced shutdown of production is required
Legal proceedings, prosecutions, malpractice, and negligence
Fraudulent activities and corruption.
2.5.15 Requirements for Organizations with Multi-Site Certification
(Food Chain Categories E, F & G)
2.5.15.1 – Central function

Requirements for the management of the central function to ensure that
sufficient resources are available, and that roles, responsibilities and
requirements are clearly defined
2.5.15.2 - Internal Audit Requirements
An internal audit procedure and program shall be established by the central
function covering the management system, central function, and all sites.
Food Safety Management System
End
Tony Connor
Food Safety Friday
September 2019
https://www.ifsqn.com/food_safety_videos.html/_/ifsqn-videos/food-safety-
fridays/implementing-an-iso-220002018-compliant-food-safety-management-system
FSSC 22000 Food Safety Management
System for Food Manufacturers - Version 6
Implementation Package
Website link www.ifsqn.com

✓ Food Safety Management System
Procedures & Records
✓ Prerequisite Programmes Manual
✓ HACCP Documentation & Tools including the
FSSC 22000 HACCP Calculator
✓ Laboratory Quality Manual
✓ A set of PowerPoint Training Presentations
covering ISO 22000, GMPs, Prerequisites,
HACCP and Internal Audits
✓ ISO 22000/22002-1/FSSC 22000 Additional
Requirements Gap Analysis Checklists
✓ New FSSC 22000 Implementation Workbook to
guide you through the implementation of your
FSSC 22000 compliant Food Safety Management
System
✓ Start Up Guide
✓ Free online support via e-mail
Food Safety Management System
Any Questions
Tony Connor

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Implementing an FSSC 22000 Version 6

Compliant Food Safety Management System

The FSSC 22000 Food Safety System Certification Scheme provides a

The FSSC 22000-Quality program is being

(Note: Category A Farming

Part II: REQUIREMENTS

BIII Pre-process handling of plant products

ISO 22000 ISO 9001

* Plus control of external processes,

4.3 Determining the scope of the food safety

The objectives of the FSMS shall:

When planning how to achieve its objectives for the

8.1 Operational planning and control

BACK TO: 8.2 Prerequisite programmes (PRPs)

a) construction, lay-out of buildings and associated utilities;

f) supplier approval and assurance processes (e.g. raw materials,

The organization should consider:

This standard will be replaced

✓ 4.1 General requirements

✓ 4.1 General requirements

Requirements for appropriate buildings in terms of construction

✓ 5.1 General requirements

5. Layout of premises workspace

Internal layouts need to be designed, constructed and maintained to

6. Utilities – air, water, energy

Utility supplies and distribution routes to and around processing and

Systems should ensure that waste materials are identified,

✓ 8.1 General requirements

Food contact equipment must be of hygienic design

Risks of indirect contact should be managed.

✓ 9.1 General requirements

Systems should be in place for the purchase and

Systems should be in place to prevent, control and

Systems should be in place to prevent, control and detect

Verification Monitoring method:

Validation/Verification Monitoring method

Cleaning and sanitizing programmes should ensure that food-

12th April 2023 12th April 2023 12th April 2023

12. Pest control

Pest prevention measures should be in place to minimize the risk

✓ Illness notification procedures for employees

The company should have a documented hygiene policy that is

Personal hygiene and behaviors should be established

Personal hygiene and behaviors should be established

✓ 14.1 General requirements

✓ 14.1 General requirements

Systems should be in place to ensure that rework is stored,

✓ 15.1 General requirements

Product recall procedures should ensure that

✓ 16.1 General requirements

Materials and products need to be stored in clean, dry, ventilated

✓ 16.1 General requirements

Materials and products need to be stored in clean, dry, ventilated

✓ 16.1 General requirements

Materials and products need to be stored in clean, dry, ventilated

17. Product information /consumer awareness

✓ 17.1 Product information

Product information should be presented to consumers in such

✓ 18.1 General requirements