ISO 22000 Clauses Requirements and Documentation training ISO 22000 RS 184 HACCP

ISO 22000:2018
FOOD SAFETY MANAGEMENT
SYSTEMS — REQUIREMENTS FOR
ANY ORGANIZATION IN THE FOOD
CHAIN
& DOCUMENTATION
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MMC/INTAS- ISO 22000:2018 FSMS & PRPS Awareness Training Course
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ISO 22000:2018
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MMC/INTAS- ISO 22000:2018 AND RS 184 HACCP REQUIREMENTS AND DOCUMENTATION TRAINING
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WHAT IS ISO?
 International Organization for Standardization (ISO) - a
world wide federation of National standards bodies from
over 163 countries. (Rwanda- RSB)
 It is based in Geneva – Switzerland (established in 1947)
The Mission of ISO is to:
 Promote standardization
 Facilitate the international exchange of goods and
services
(www.iso.org )
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RWANDA ISO MEMBERSHIP AND BENEFITS
Rwanda is a member of the regional and international
standards setting bodies such as :
 International Organization for Standardization (ISO),
 International Organization for Legal Metrology (OIML),
 Codex Alimentarius Commission,
 International Measurement Confederation (IMEKO)
 African Organization for Standardization (ARSO),
 African Electro technical Standardization Commission
(AFSEC),
 ITU,
 East African Community (EAC), and
 AFRIMET.
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BENEFITS OF ISO MEMBERSHIP
• Right to access to a collection of international
standards which can be adopted at the national
level free of charge,
• Enable the country to be a standards setter
• Participation in conformity assessment and
metrology fora
• Technical assistance programmes upon which
the policy implementation can build.
Issue : Apr 2020 MMC/INTAS- ISO 22000:2018 AND RS 184 HACCP REQUIREMENTS AND DOCUMENTATION TRAINING

ISO22000:2018
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▸The first edition of ISO 22000 was published in
2005 by the International Organization for
Standardization (ISO).
▸It has since been revised and the current edition is
ISO 22000:2018, released in June 2018
History of the standard

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The ISO 22000 series comprises of the following:
ISO 22000:2018 Food safety management systems —
Requirements for any organization in the food chain
ISO/TS 22002-1:2009 PRP on food safety - Food
manufacturing
ISO/TS 22002-2:2013 PRP on food safety - Catering
ISO/TS 22002-3:2011 PRP on food safety - Farming
ISO/TS 22002-4:2013 PRP on food safety - Food
packaging manufacturing
ISO 22004:2014 - Guidance on the application of ISO
22000
ISO 22005:2007 Traceability in the feed and food chain -
General principles and basic requirements for system
design and implementation
ISO 22000 Family

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• ISO/TS 22002-6:2016 PRP on food safety - Feed and
animal food production
• ISO/TS 22003:2013 FSMS - Requirements for bodies
providing audit and certification of Food Safety
Management Systems
• ISO 10012:2003 Measurement management systems -
Requirements for measurement processes and measuring
equipment
• ISO/TR 10013:2001 - Guidance for quality management
system documentation
• ISO 1015:1999 Quality Management - Guidelines for
training
• ISO 19011:2018 - Guidelines for auditing management
systems
• ISO 31000:2018 Risk management - Guidelines
ISO 22000 Family cont’d

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Food Safety Systems Certification (FSSC 22000) -ISO
22000 +BSI PAS 220)
Global Food Safety Initiative(GFSI) –The below are
benchmarked to GFSI
British Retail Consortium (BRC) Technical Standards
BRC/IOP International Organization for Packaging
BRC Global Standard for Safety Standard
Global-GAP (Good Agricultural Practices)
Safe Quality Food –SQF
International Featured Standard for Food Safety (IFS)
Codex Hygiene Principles
Local /regional /national/international/regulatory/
statutory
Note (see handout on list of RS and other standards)
Other food safety related standards/Codes

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GFSI Benchmarked schemes International
standards
BRC IFS SQF 2000 FSSC
22000
GlobalGAP SQF 1000
ISO
22000
CODEX
Hygiene
Principles
& other
relevant
codes
Geogra
phic
focus
British
market
German,
French
and
Italian
market
US and
Australi
an
market
Europe Internatio
nal
(mainly
Europe)
US and
Australian
market
Internatio
nal
Internatio
nal
Owner
s
British
retail
members
and trade
associations
German,
French
and
Italian
retail
associatio
ns
US
retailer
associatio
ns
Foundatio
n for Food
Safety
Certificati
on
European
retail
associatio
ns
US retailer
association
s
Internation
al
Standards
Organizati
on
FAO/WHO
End users
(who apply
the std)
Food
manufacturer
s
Food
manufactur
ers
Food
manufactur
ers
Food
manufacture
rs
Primary
producers
Primary
producers
entire food
chain
entire food
chain

Application and Scope
ISO 22000:2018 specifies requirements for a food
safety management system where an organization in
the food chain:
 Needs to demonstrate its ability to control food safety
hazards in order to ensure that food is safe at the time
of human consumption
 Aims to enhance customer satisfaction through the
effective control of food safety hazards, including
processes for updating the system
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Application and Scope cont’d
Requirements are:
 generic and
 applicable to all organizations in the food
chain regardless of size and complexity.
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The Four pillars of ISO 22000
Interactive communication :
Internal and external (throughout the food
chain)
System Management:
Policy, commitment, organization, resources
(incorporated into overall management
activities of the organization)
Prerequisite programmes:
HACCP principles:
management of critical control points
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You can purchase the domesticated copy of the
standard from Rwanda Standards Board
RS no: RS ISO 22000:2018
Contact: info@rsb.gov.rw

Session 1:
ISO 22000:2018
REQUIREMENTS IN DETAILS
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ISO 22000:2018
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Clause 1 – Scope
Clause 2 – Normative References
Clause 3 – Terms and Definitions
Clause 4 – Context of The Organization
Clause 5 – Leadership
Clause 6 – Planning
Clause 7 –Planning
Clause 8- Operation
Clause 9- Performance Evaluation
Clause 10- Improvement
ISO 22000:2018 STANDARD CLAUSES AT A GLANCE

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Clause 3
Terms and Definitions
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Significant food safety hazard- Food safety hazard
identified by an organization through the hazard assessment
that needs to be controlled by specific control measures
Control measures= Action or activity used to prevent a
significant food safety hazard or reduce it to an acceptable
level
Acceptable level - Level of a food safety hazard that must
not exceed in the finished product
Action criterion- Measurable or observable specification for
the monitoring of an operational prerequisite programme
(OPRP). This action criterion is established to assess whether
the OPRP is under control
Some selected Terms and Definitions

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Competence- Ability to apply knowledge and skills to get
intended results ‘
Interested party-Person or organization that can affect, be
affected by, or perceive itself to be affected by a decision or
activity
Outsource - Arrangement made where an external company
(outside the scope of the management system) performs part of a
function or internal process within the scope
Some selected Terms and Definitions Cont’d

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Risk- Effect of uncertainty; whereas effect means a deviation
from the expected (positive or negative), uncertainty is in fact a
state, even partial, of deficiency of information related to the
understanding or knowledge of an event, its consequence, or
likelihood.
Risk is no longer only applicable to the operational level of the
organization, but it is implied in all aspects of the system that
could affect food safety
Critical Control Point (CCP)- Step in a process at which a
control measure can be applied and it is essential to prevent or
reduce a significant food safety hazard to an acceptable level.
Critical limits and measurement enable the application of
corrections. Both, CCPs and OPRPs require monitoring,
validation and verification

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Operational Prerequisite Programme (OPRP)- Control
measures identified through the hazard analysis as essential to
prevent or reduce to an acceptable level the probability of
introducing risks and/or contamination or proliferation of a
significant food safety hazard in food products or in the work
environment. Action criterion and measurement or observations
enable effective control of these processes. (These are more
specific to each organization than the PRPs)
Monitoring- Planned sequence of observations or
measurements to evaluate whether a process is operating as
intended. Monitoring shall be applied during an activity and
provides information for action during a specified time frame
(“present assessment”)

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Validation -Obtaining evidence that a control measure will be
capable of effectively controlling a significant food safety
hazard. Validation shall be applied prior an activity and
provides information about the capability to deliver intended
results (“future assessment”)
Verification- Confirmation, through the provision of objective
evidence, that specified requirements have been fulfilled.
Verification shall be applied after an activity and provides
information for confirmation of conformity (“past assessment”)

ISO 22000:2018
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Clause 4
Context of the
Organization
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4.1.
4.2.
4.3.
Understanding the organization and
its context
Understanding the needs and
expectations of interested parties
Determining the scope of the FSMS
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4.4 Food Safety Management System

4.1 Understanding the organization and its
context
The organization shall determine external and internal
issues that are relevant to its purpose and that
affect its ability to achieve the intended result(s) of its
FSMS.
The organization shall identify, review and update
information related to these external and internal issues.
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CONTEXT OF THE ORGANIZATION
External Issues
• Cultural, social, political, legal, financial, technological,
economic and natural surroundings including the environment
in which the organization operates
• Who the competitors are and any contractors,
subcontractors, suppliers, partners and providers
• National and international law
• Industry drivers and trends which have influence on the
organization
• The organization products and services and their influence
on food safety
• Availability and variety of external providers of services/
products
• Changes in consumption patterns
• Capacity of changes regarding premises (landlord)

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Internal Issues
• Governance, organizational structure, roles and
accountabilities
• Policies, objectives and the strategies in place to achieve
them
• Competence of personnel
• Food Safety culture within the organization and the
relationship with workers
• Process for the introduction of new products, materials,
services, tools, software, premises and equipment
• Working conditions
• Resources (under-utilisation of resources)
• Retention of skilled employees
• Number and variety of clients/ customers
• Linkage to a certain activity, location and/or period

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PRIORITY INTERNAL EXTERNAL (INTERNATIONAL,
NATIONAL, REGIONAL OR LOCAL)
H VALUES LEGAL
L CULTURE TECHNOLOGICAL
L KNOWLEDGE COMPETITIVE
H PERFORMANCE OF THE
ORGANIZATION
MARKET
M CULTURAL
H INTENTIONAL
CONTAMINATION?
SOCIAL
H CYBERSECURITY? ECONOMIC
FOOD FRAUD/FOOD DEFENCE
• Issues include both positive & negative
• These issues must be monitored & reviewed…

4.2 Understanding the needs and expectations
of interested parties
IQA TRAINING
The organization shall determine:
a) the interested parties that are relevant to the FSMS;
b) the relevant requirements of the interested parties of the FSMS.
The organization shall identify, review and update information
related to the interested parties and their requirements.
Def: The interested party can be anybody: regulators, customers,
employees, landlords, consumers, distributors, trade suppliers,
shareholders, etc.
Some of the interested parties’ expectations and needs are mandatory;
hence, they are enshrined into the regulatory requirements and laws.
For that reason, they must be considered at all costs.
All the identifiable interested parties and their expectations and needs
must be reviewed once they’ve been defined and after the organization has
applied some changes.
ISO 22000:2018
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IQA TRAINING
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Examples of Interested Parties and their needs and expectations
Interested Party Needs and Expectations
Customers/
End -Users
 Safe, price and delivery performance of
products
 Quality food products prepared in hygienic
conditions in the absence of all health hazards
Owners/shareholders  Sustained profitability/dividends
 Reliable and long term cooperation, and
 Minimal risk of supply chain disruptions.
 Legal and financial compliance
 Avoiding fines and penalties
 Recording excellent performance.
People in the
organization/
Employees
 Healthy, hygienic, and safe working
environment that poses no occupational
infections or injuries
 Recognition and reward

IQA TRAINING
ISO 22000:2018
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Examples of Interested Parties and their needs and expectations
Interested Party Needs and Expectations
Suppliers and partners  Mutual benefits
 Continuous orders
 Prompt payments
 Long working relationship
Society/community  Improve human health,
 Minimize the risk of poisoning
 Contribute to the local population
Legislative and Regulatory
Authorities/ Bodies (can
be international, national,
provincial/regional or
local)
 Collective health of the people and their
longevity – part of the country’s
sustainable development plan
 Compliance with international
standards, regulations, and national
laws

4.3 Determining the scope of the food safety management
system
IQA TRAINING
The organization shall determine the boundaries and
applicability of the FSMS to establish its scope.
When determining this scope, the organization shall consider:
a) the external and internal issues referred to in 4.1;
b) the requirements referred to in 4.2.
The scope shall specify:
• products and services,
• processes and
• production site(s) that are included in the FSMS.
The Scope shall be available and maintained as documented
information.
(Refer to workshop no 1)
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4.4 Food safety management system
The organization shall establish, implement, maintain,
update and continually improve a FSMS, including the
processes needed and their interactions, in accordance
with the requirements of this document.
 Material sourcing
 Sales
 Production
 QC/QA
 Storage
Interactions?
ISO 22000:2018
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Exercise No.1 –Understanding the Context of the organization
ISO 22000:2018
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PURPOSE:
The purpose of this workshop is to understand how to determine the context
of the organization (clause 4.1 and clause 4.2)
INSTRUCTIONS FOR DELEGATES:
1. In groups of 3-5 members, scan the environment in which your
organization operates and identify the internal and external factors
affecting its ability to achieve the intended result(s) of its FSMS.
2. Identify at least five interested parties and their needs and expectations.
OUTPUT
1. Be prepared to give your feedback to the whole class
TIME ALLOWED
Workshop 40 minutes
Feedback 20 minutes

Clause 5.
Leadership
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5.1 Leadership & Commitment
5.2 Policy
5.3 Organizational roles,
responsibilities and authorities
5. Leadership
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5 Leadership
5.1 Leadership and commitment
Top management shall demonstrate leadership and
commitment with respect to the FSMS by:
 Taking accountability
• Establishing the food safety policy and objectives of
FSMS
• Ensuring integration of FSMS into business
processes
• Ensuring resources needed are available
1/21/2021
ISO 22000:2018
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5.1 Leadership and commitment cont’d
• Communicating the importance of effective food
safety management through food safety policy
• ensuring that the FSMS is evaluated and maintained
to achieve its intended result(s) through
management reviews
• Directing and supporting persons to contribute to the
effectiveness of the FSMS through trainings
• Promoting continual improvement
• Supporting other relevant management roles
1/21/2021
ISO 22000:2018
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5.2 Policy
5.2.1 Establishing the food safety policy
Top management shall establish, implement and maintain a
food safety policy that:
a) is appropriate to the purpose and context of the
organization;
b) provides a framework for setting and reviewing the
objectives of the FSMS;
c) includes a commitment to satisfy applicable food safety
requirements, including statutory and regulatory
requirements and mutually agreed customer requirements
related to food safety;
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5.2.1 Establishing the food safety policy cont’d
d) addresses internal and external
communication;
e) includes a commitment to continual
improvement of the FSMS;
f) addresses the need to ensure competencies
related to food safety.
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ISO22000:2018
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5.2.2 Communicating the food safety policy
The food safety policy shall:
a) be available and maintained as documented
information;
b) be communicated, understood and applied at all
levels within the organization;
c) be available to relevant interested parties, as
appropriate.
Communication tools: Meetings • Recruitment packs •
Induction packs • Supplier evaluations • Supplier contracts •
Notice boards on site • Website / intranet site • Annual staff
appraisals etc
1/21/2021
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1/21/2021
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EXAMPLE OF A FOOD SAFETY POLICY– WORKSHOP 8
FOOD SAFETY POLICY STATEMENT
XYZ is committed to offer fine, safe, food ingredients and new ingredient technology across
the whole food sector to all countries in sub-Saharan Africa from our international network of
expertise and from our business enterprises . In pursuit of this commitment, we shall:
 Implement and maintain a Food Safety Management System in accordance with ISO
22000: 2018 International standard and continually improve its effectiveness,
 Identify, evaluate and control all potential food safety hazards within the defined scope,
 Ensure all staff are competent in their area of expertise.
 Incorporating the risk-based thinking principles in our work.
 Ensure effective communication to responsible parties on food safety related issues.
 Conform to applicable statutory and regulatory requirements and mutually agreed food
safety requirements of the intended users,
 Establish, review and update food safety objectives.
This policy shall be reviewed during management reviews for continued suitability and
communicated to all employees and other relevant interested parties.
Signed: General Manager Date:

5.3 Organizational roles, responsibilities and
authorities
Top management shall ensure that the responsibilities and
authorities for relevant roles are assigned, communicated
and understood within the organization.
Examples include organizational charts (authority) and
employees’ job descriptions (responsibilities)
Example of a statement: All the employees working at the Feed
Production are responsible for reporting any food safety hazard
to FST identified during routine activities--------------
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Who is responsible for what?
.All personnel must know what it is expected from them
(responsibilities) and what top management allows them to do
(authorities).
This can be easily implemented through an organogram and job
descriptions of all staff of the organization with their duties and
authorities described.
ISO 22000 does specify a requirement for a nominated food safety
team leader that ensures the system is established, implemented,
maintained and updated when required.
This person must have suitable authority to manage the system,
ensure the work is managed as well as the relevant training and
competencies of the food safety team, report on the effectiveness
and suitability of the FSMS and make continual improvements as
determined by top management.
1/21/2021
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5.3 Organizational roles, responsibilities and authorities (Cont’d )
Top management shall assign the responsibility and
authority for:
a)ensuring that the FSMS conforms to the requirements of
this document;
b)reporting on the performance of the FSMS to top
management;
c)appointing the food safety team and the food safety team
leader;
d)designating persons with defined responsibility and
authority to initiate and document action(s).
1/21/2021
ISO 22000:2018
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5.3 Organizational roles, responsibilities and authorities (Cont’d )
The food safety team leader shall be responsible for:
a) ensuring the FSMS is established, implemented, maintained and
updated;
b) managing and organizing the work of the food safety team;
c) ensuring relevant training and competencies for the food safety
team (see 7.2);
d) reporting to top management on the effectiveness and
suitability of the FSMS.
All persons shall have responsibility to report problem(s) with the
food safety management system to identified person(s).
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Clause 6
Planning
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6.1 Actions to address risks &
opportunities
6.2 Objectives of the food safety
management system and
planning to achieve them
6.3 Planning of changes
6. Planning
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6.1 Actions to address risks and
opportunities
When planning for the FSMS, the organization
shall consider its context and determine the
risks and opportunities that need to be
addressed to:
a) give assurance that the FSMS can achieve its
intended result(s);
b) enhance desirable effects;
c) prevent, or reduce, undesired effects;
d) achieve continual improvement.
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ISO 22000:2018
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RISK-BASED THINKING

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Risk-Based Thinking
Risk is the effect of uncertainty on objectives,
and any such uncertainty can have positive or
negative effects

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By considering risk throughout the organization
 the likelihood of achieving stated FSMS objectives
is improved,
 output is more consistent and
 customers can be confident that they will receive
the expected product or service
Why use risk-based thinking?

ISO 22000:2018
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Risk-based thinking-how is it done?
Identify what your risks are - it depends on context,
interested parties
prioritize the way you manage your processes
balance risks and opportunities
Analyse and prioritize your risks
what is acceptable? what is unacceptable? What advantages or
disadvantages are there to one process over another?)
Evaluate - Plan actions to address the risks
how can I avoid, eliminate or mitigate risks?
Treat / Address - Implement the plan; take action
reduce the probability
Monitor / Review
check the effectiveness; does it work?
learn from experience; improve

6.1 Actions to address risks and opportunities (cont’d)
The organization shall plan:
a) actions to address these risks and opportunities;
b) how to:
1) integrate and implement the actions into its FSMS
processes;
2) evaluate the effectiveness of these actions.
Note: Public authorities are responsible for addressing public
health risks.
Organizations are required to manage food safety
hazards (see 3.22) and the requirements related to this
process that are laid down in Clause 8.
1/21/2021
ISO 22000:2018
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The actions taken by the organization to address risks and
opportunities shall be proportionate to:
a) the impact on food safety requirements;
b) the conformity of food products and services to
customers;
c) requirements of interested parties in the food chain.
By addressing organizational risks, businesses can act to
prevent undesirable effects and take advantages of
opportunities aimed at improving overall performance.
ISO 22000:2018
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When identifying risks, organizations should consider:
 Context of the organization (internal and external issues)
 Scope of the food safety management system
 Requirements of interested parties
Organizational risks can be addressed by
 mitigation,
 sharing,
 transfer,
 acceptance by informed decision or
 taking a risk to pursue an opportunity.
Examples of opportunities: Technology change/new
practices, Modification of products or processes…..
ISO 22000:2018
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Def: Organizational risks relate to any events that could
potentially impact on the performance and effectiveness of the
FSMS. *Ref to clause 4.1/4.2
Examples of these events may include but are not limited to:-
 Resource availability,
 Changes to Regulatory/Statutory requirements,
 Reliance on sole/key suppliers,
 Changing customer needs,
 Competitors,
 Ageing equipment,
 Organizational culture and behaviour,
 Reliance on small number of key customers..
Examples of organizational risks
ISO 22000:2018
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ISO22000:2018
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PURPOSE: The purpose of this workshop is to practice using an appropriate framework in
conducting risk assessment when processes and FSMS deviates from planned results. It also
gives a learning curve on proposing opportunities.
1. Form teams of 3-5 people per group.
2. Choose one of these Processes:
 Recruitment of catering personnel
 Customer care at manufacturing factory
 Purchasing of storage premises
3. Using the format provided, name at least four risks that must be addressed to ensure
efficiency of the process and analyze them. Propose one opportunity for each risk.
4. Prepare to share your work in class.
Time Allowed:
Workshop: 40 minutes
Feedback: 20 minutes per team
Workshop 2: Risk Analysis
Issue : Apr 2020

6.2 Objectives of the food safety management system
and planning to achieve them
The organization shall establish objectives for
the FSMS at relevant functions and levels.
The organization shall retain documented information
on the objectives for the FSMS.
1/21/2021
ISO 22000:2018
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and planning to achieve them (Cont’d)
The objectives of the FSMS shall::
a) be consistent with the food safety policy;
b) be measurable (if practicable);
c) take into account applicable food safety requirements,
including statutory, regulatory and customer
requirements;
d) be monitored and verified;
e) be communicated;
f) be maintained and updated as appropriate.
1/21/2021
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1/21/2021
ISO 22000:2018
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PURPOSE: The purpose of this exercise is to have an understanding SMART
FSMS objectives in an organization.
INSTRUCTIONS FOR DELEGATES: Review the listed objectives and decide
whether are SMART
S- Specific, as precise as possible•
M- Measurable, quantifiable so we can monitor progress
A- Achievable, failure shall not be built into objectives
R• Realistic, possible for your organization
T- Timely, with a completion date established
a. To reduce rework by 5% from the previous year.
b. To ensure that we respond to customer complaints within 4 hours.
OUTPUT : Be prepared to give your feedback to the whole class
TIME ALLOWED
Exercise 30 minutes Feedback 10 minutes
Exercise 3 SMART Food safety Objectives

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.
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and planning to achieve them (Cont’d)

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OBJECTIVE (state the objective)
To reduce the number of food safety related customer complaints
by 40% (from 5 to ) from the previous year 2019.
Strategy (Actions/Activities required to achieve the objective
1. Training staff on food safety aspects
2. Procurement of safe and quality raw materials including packaging
materials
3. Ensure proper handling and storage of raw materials and end products
4. Implement PDCA cycle
RESPONSIBILITY RESOURCES
REQUIRED
TIMELINE MEASURE OF
SUCCESS (KPIs)
FSTL Personnel
Finance
Infrastructure
Quarterly 3 complaints
Review dates: 31st December , 2020
Example: Food Safety Objective

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PURPOSE: The purpose of this workshop is to understand how to establish
measurable food safety objectives that are aligned to the strategic direction of the
organization.
1. Form teams of 3-5 people per group.
2. Using the format provided, establish at least one objective from any of the
three themes below: Strategic Themes
 People
 Business leadership
 Image and reputation
3. Prepare to share your work in class.
Time Allowed:
Workshop: 40 minutes
Feedback: 20 minutes per team
Workshop 3: Food Safety Objectives

When the organization determines the need for changes
to the FSMS, the changes shall be carried out in a
planned manner.
The organization shall consider:
a) the purpose of the changes and their potential consequences;
b) the continued integrity of the FSMS;
c) the availability of resources to effectively implement the
changes;
d) the allocation or re-allocation of responsibilities and authorities.
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Managing change process
When there is change in the system, your organization must
maintain the integrity of the FSMS, so the changes must be
considered and a revision conducted to implement them.
Note: Take into account
 The extent of the changes deemed necessary,
 The potential impact on the existing system,
 How you will resource the changes and
 Any effect this may have on current roles,
responsibilities and authorities.

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Change managing process cont’d
 Clearly define the change and align it to
business goals
 Determine impacts and those affected
 Develop a communication strategy
 Provide effective training
 Implement a support structure
 Measure the change process

CLAUSE 7
SUPPORT
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7. Support
7.2
7.5
7.3
7.4
7.1
Resources
Competence
Awareness
Documented
Information
Communication
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7.1 Resources
7.1.1 General
The organization shall determine and provide the
resources needed for the establishment, implementation,
maintenance, update and continual improvement of the
FSMS.
The organization to consider
a) the capability of, and any constraints on, existing internal resources;
b) the need for external resources.
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7.1.2 People
The organization shall ensure that persons necessary to
operate and maintain an effective FSMS are competent
External experts can be used for the development,
implementation, operation or assessment of the FSMS.
Evidence to be retained as documented information.
Competence is based on education, training, skills and
experience
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7.1.3 Infrastructure
The organization shall provide the resources for the
determination, establishment and maintenance of the
infrastructure necessary to achieve conformity with the
requirements of the FSMS.
Infrastructure can include:
 land, vessel, buildings and associated utilities;
 equipment, including hardware and software;
 transportation;
 information and communication technology..
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7.1.4 Work environment
The organization shall determine, provide and maintain the
resources for the establishment, management and maintenance of
the work environment necessary to achieve conformity with the
requirements of the FSMS.
Environment can be a combination of human and physical factors
such as:
a) social (e.g. non-discriminatory, calm, non- confrontational);
b) psychological (e.g. stress-reducing, burnout prevention,
emotionally protective);
c) physical (e.g. temperature, heat, humidity, light, air flow, hygiene,
noise).
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7.1.5 Externally developed elements of the food safety management system
When an organization establishes, maintains, updates and continually
improves its food safety management system by using externally
developed elements of a food safety management system including PRPs
and the hazard control plan, the organization shall ensure that the
provided elements are:
a) developed in conformance with requirements of this document;
b) applicable to the sites, processes and products of the organization;
c) specifically adapted, by the food safety team to the processes and
products of the organization; and,
d) implemented, maintained and updated as required by this document;
e) retained as documented information.
IQA TRAINING
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7.1.6 Control of externally provided processes, products or services
The organization shall:
a) establish and apply criteria for the evaluation, selection,
monitoring of performance and reevaluation 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..
IQA TRAINING
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Supplier Evaluation Sheet
HANNJO NUTS LIMITED
1. Mode of production
Acreage of the farm (where applicable)
Number and location of collection
centers ( Please Attach List)
Type and frequency of chemicals used
(where applicable)
Mode of harvesting
Storage of produce before delivery
Packaging of produce during transit
Mode of transport (indicate whether
own or outsourced)
2. Are the employees trained on good agricultural and hygienic
practices?
If yes, provide evidence.
3. Which other companies/processors are you currently supplying?
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
4. What are the expected delivery times?
______________________________________________________________________________________________________

7.2 Competence
a) determine the necessary competence of person(s), including external
providers, doing work under its control that affects its food safety
performance and effectiveness of the FSMS;
b) ensure that these persons, including the food safety team and those
responsible for the operation of the hazard control plan, are competent
on the basis of appropriate education, training and/or experience;
c) ensure that the food safety team has a combination of multi- disciplinary
knowledge and experience in developing and implementing the FSMS
(including, but not limited to, the organization’s products, processes,
equipment and food safety hazards within the scope of the FSMS);
d) where applicable, take actions to acquire the necessary competence, and
evaluate the effectiveness of the actions taken;
e) retain appropriate documented information as evidence of competence.
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Competence can include consideration for
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 Capability to fulfil the task based on defined job roles and
clear understanding of the consequences of its
performance in food safety
 Knowledge and experience of the food safety team
 Defined methods of recruitment with consideration for
temporary or agency employees
 Awareness of food safety hazards associated with the
products and processes
 Legal requirements
 Individual capabilities including experience, language
skills, literacy and diversity

7.3 Awareness
The organization shall ensure that all relevant persons
doing work under the organization’s control are aware of:
a) the food safety policy;
b) the objectives of the FSMS relevant to their task(s);
c) their individual contribution to the effectiveness of
the FSMS, including the benefits of improved food
safety performance;
d) the implications of not conforming with the FSMS
requirements.
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7.4 Communication
The organization shall determine the internal
and external communications relevant to the
FSMS, including::
a) on what it will communicate;
b) when to communicate;
c) with whom to communicate;
d) how to communicate;
e) who communicates.
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7.4.2 External communication
The organization shall ensure that sufficient information
is communicated externally and is available for
interested parties of the food chain.
The organization shall establish, implement and
maintain effective communications with:
a) external providers and contractors;
b) customers and/or consumers, in relation to:
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The organization shall establish, implement and maintain
effective communications with customers and/or consumers, in
relation to:
1) product information related to food safety, to enable the
handling, display, storage, preparation, distribution and use
of the product within the food chain or by the consumer;
2) identified foods safety hazards that need to be controlled by
other organizations in the food chain and/or by consumers;
3) contractual arrangements, enquiries and orders, including
their amendments;
4) customer and/or consumer feedback, including complaints;
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maintain effective communications with:
c) statutory and regulatory authorities;
d) other organizations that have an impact on, or will be
affected by, the effectiveness or updating of
the FSMS.
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Designated persons shall have defined responsibility and
authority for the external communication of any
information concerning food safety.
Where relevant, information obtained through external
communication shall be included as input for
management review (see 9.3) and for updating the FSMS
(see 4.4 and 10.3).
Evidence of external communication shall be retained as
documented information.
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7.4.3 Internal communication
maintain an effective system for communicating issues
having an impact on food safety.
To maintain the effectiveness of the FSMS, the
organization shall ensure that the food safety team is
informed in a timely manner of changes in the following:
a) products or new products;
b) raw materials, ingredients and services;
c) production systems and equipment;
d) production premises, location of equipment and
surrounding environment;
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e) cleaning and sanitation programmes;
f) packaging, storage and distribution systems;
g) competencies and/or allocation of responsibilities
and authorizations;
h) applicable statutory and regulatory requirements;
i) knowledge regarding food safety hazards and control
measures;
j) customer, sector and other requirements that the
organization observes;
k) relevant enquiries and communications from external
interested parties;
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l) complaints and alerts indicating food safety hazards associated
with the end product;
m) other conditions that have an impact on food safety.
The food safety team shall ensure that this information is included
when updating the FSMS (see 4.4 and 10.3).
Top management shall ensure that relevant information is included as
input to the management review (see 9.3).
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PURPOSE:
1. The purpose of this exercise is to have an understanding how an effective and
efficient internal and external communications are the “key” to running a FSMS.
2. To understand the framework depict the communication process/ matrix of
the organization
1. In groups of 3-5 members, refer to clauses nos 4.2, 7.4.1 and 7.4.2
2. Use the format to come up with a communication matrix
OUTPUT
1. Be prepared to give your feedback to the whole class
TIME ALLOWED
Workshop 30 minutes
Feedback 10 minutes
Exercise 2: Internal and external communication

7.5 Documented Information
7.5
General
Creating &
Updating
Control of
Documented
Information
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7.5 Documented information
7.5.1 General
The organization’s FSMS shall include:
a) documented information required by this document;
e.g. FSMS Policy, scope of the fsms and fsms objectives
a) documented information determined by the organization as
being necessary for the effectiveness of the FSMS;
e.g. HACCP plan, SOPs, Work instruction.
a) documented information and food safety requirements
required by statutory, regulatory authorities and customers.
E.g. First Aid Training, fire safety inspection records, Hygiene training
records, food handlers medical records,
See annex 3
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7.5.2 Creating and updating
When creating and updating documented information,
the organization shall ensure appropriate:
a) identification and description (e.g. a title, date,
author, or reference number);
b) format (e.g. language, software version, graphics)
and media (e.g. paper, electronic);
c) review and approval for suitability and adequacy.
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7.5.3 Control of documented information
Documented information shall be controlled to
ensure:
a) it is available and suitable for use, where and
when it is needed;
b) it is adequately protected (e.g. from loss of
confidentiality, improper use, or loss of
integrity
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For the control of documented information, the
organization shall address the following activities,
as applicable:
a) distribution, access, retrieval and use;
b) storage and preservation, including
preservation of legibility;
c) control of changes (e.g. version control);
d) retention and disposition.
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Documented information of external origin
determined by the organization to be necessary for
the planning and operation of the FSMS shall be
identified, as appropriate, and controlled.
Documented information retained as evidence of
conformity shall be protected from unintended
alterations.
Examples: ISO standards, RS standards, Codes,
Legal requirements, etc
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Clause 8
Operation
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8.1 Operational planning and control
8.2 Prerequisite programmes (PRPs)
8.3 Traceability System
8.4 Emergency preparedness and response
8.5 Hazard control
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
8.9 Control of product and process nonconformities
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8.1 Operational planning and control
The organization shall plan, implement, control, maintain and update
the processes needed to meet requirements for the realization of safe
products, and to implement the actions determined in 6.1, by:
a) establishing criteria for the processes;
b) implementing control of the processes in accordance with the
criteria;
c) keeping documented information to the extent necessary to have
the confidence to demonstrate that the processes have been
carried out as planned.
The organization shall control planned changes and review the
consequences of unintended changes, taking action to mitigate any
adverse effects, as necessary.
The organization shall ensure that outsourced processes are
controlled (see 7.1.6).
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Workshop 4: Operational Controls -Outsourced
Purpose
To develop learners’ understanding of the requirements of operational
planning and controls for outsourced processes, products and services
Form teams of 3-5 people per group.
Choose one of these Processes or Product or Service
Certification
Maintenance
Catering services
Additives
Pest Control
Name at least 4 controls to ensure efficiency of the process, product or
service. .
Prepare to share your work in class.
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8.2 Prerequisite programmes (PRPs)
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.
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Prerequisite programmes (PRPs)
8.2.2 The PRP(s) shall be:
a) appropriate to the organization and its context with
regard to food safety;
b) 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.
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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.
Which series in D, E, G?------------
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8.2.4 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;
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8.2.4 When establishing PRP(s) the organization shall
consider:
d) pest control, waste and sewage disposal and supporting
services;
e) the suitability of equipment and its accessibility for
cleaning and maintenance;
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;
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h) measures for the prevention of cross
contamination;
i) cleaning and disinfecting;
j) personal hygiene;
k) product information/consumer awareness;
l) others, as appropriate.
Documented information shall specify the
selection, establishment, applicable monitoring
and verification of the PRP(s).;
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8.3 Traceability system
The traceability system shall be able to uniquely identify
incoming material from the suppliers and the first stage of the
distribution route of the end product.
When establishing and implementing the traceability system, the
following shall be considered as a minimum:
a) relation of lots of received materials, ingredients and
intermediate products to the end products;
b) reworking of materials/products;
c) distribution of the end product.
The organization shall ensure that applicable statutory,
regulatory and customer requirements are identified..
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8.4 Emergency preparedness and response
8.4.1 General
Top management shall ensure procedures are in place to
respond to potential emergency situations or incidents that
can have an impact on food safety which are relevant to the
role of the organization in the food chain.
Documented information shall be established and
maintained to manage these situations and incidents.
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(e.g bioterrorism, fire, flooding, fraud,
environmental, new and emerging hazards, natural
disasters, an earthquake, sabotage, blockage of
main utilities, environmental accidents, etc)

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a) respond to actual emergency situations and incidents by:
1) ensuring applicable statutory and regulatory
requirements are identified;
2) communicating internally;
3) communicating externally (e.g. suppliers, customers,
appropriate authorities, media);
b) take action to reduce the consequences of the emergency
situation, appropriate to the magnitude of the emergency or
incident and the potential food safety impact;
c) periodically test procedures where practical;
d) review and, where necessary, update the documented
information after the occurrence of any incident, emergency
situation or tests.
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
To carry out the hazard analysis, preliminary documented
information shall be collected, maintained and updated by
the food safety team.
This shall include, but not be limited to:
a) applicable statutory, regulatory and customer
requirements;
b) the organization’s products, processes and equipment;
c) food safety hazards relevant to the FSMS.
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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.
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8.5 Hazard control cont’d
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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);

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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.

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Product description
Product Name
Important characteristics, PH, etc
Packaging
How to be used
Shelf life
Special target groups
Labelling instructions
Special distribution controls

8.5.1.3 Characteristics of end products
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), including information on the following,
as appropriate:
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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.
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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).
Plenary question 1: unintended use?
Plenary question2: misuse of the end product?
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8.5.1.4 Intended use cont’d
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
Examples: the sick/ill, aged, children , pregnant
women/breastfeeding mothers, diabetics, chicks, broilers,
calves,
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8.5.1.5 Flow diagrams and description of processes
8.5.1.5.1 Preparation of the flow diagrams
The food safety team shall establish, maintain and update flow
diagrams as documented information for the products or
product categories and the processes covered by the FSMS.
8.5.1.5.2 On-site confirmation of flow diagrams
The food safety team shall confirm on-site the accuracy of the
flow diagrams, update the flow diagrams
where appropriate and retain as documented information.
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Workshop 9a: Product description and Flow Diagram
PURPOSE:
The purpose of this workshop is to practice on product description and
appropriate flow diagram for product/process of an organization.
Choose one of these product /process
Storage of tomatoes
Production of chicken feed
Preparation of Noodles
Using the format provided, describe the characteristics of raw or
finished product
Using the format provided prepare a draft flow diagram from start to
end.
.
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8.5 Hazard control
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:
8.5.2 Hazard analysis
8.5.2.1 General
The food safety team shall conduct a hazard analysis, based on
the preliminary information, to determine the hazards that need
to be controlled.
The degree of control shall ensure food safety and, where
appropriate, a combination of control measures shall be used.
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8.5 Hazard control
8.5.2.2 Hazard identification and determination of
acceptable levels
8.5.2.2.1 The organization shall identify and document all food
safety hazards that are reasonably expected to occur in relation
to the type of product, type of process and process environment.
8.5.2.3 Hazard assessment
The organization shall conduct, for each identified food safety
hazard, a hazard assessment to determine whether its
prevention or reduction to an acceptable level is essential.
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8.5 Hazard control
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HAZARD
Physical, chemical, biological agent in, or condition of,
food with a potential cause of harm to the consumer.
Chemical Pesticides residues, heavy metals
Cleaning detergents/ Lubricants, chemical
residues
Physical Metal, glass, wood, blades, soil, bolts, nuts
etc.
Biological Bacteria, fungi/ afltatoxins, virus, parasites,
Live Pests, Clostridium, Yeast, Moulds
.

8.5 Hazard control
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. SOURCES OF HAZARDS
1. Physical contamination/hazards
A. Inherent
(i) In containers
• Heavy metals. • Dust, • Iron filings from
equipment
(ii) Dried products
• Grit; • Insects
B. Introduced
(i) From the environment
Glass fragments; Metal pieces i.e. nuts, bolts, screws
and pins
Stones
Paint chippings Rust
Pieces of wood & plastic

8.5 Hazard control
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. SOURCES OF HAZARDS
Introduced
From handlers
• Jewellery
• Buttons
• Hair
• Nail fragments and nail varnish
• Cigarettes etc.

8.5 Hazard control
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.
Example – Manufacture of Feed
i) Chemical Cleaning detergents, lubricants, grease,
Heavy Metals,
ii) Physical Glass, metal, plastic, hair, paper, nuts,
iii) Biological Salmonella, Escherichia coli, Staphylococcus.
aureus, coliforms, etc.

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.
4. List of product ingredients and associated materials
i.e. compressed air
Ingredients Other ingredients
5.A detail process flow diagram needs to be available
6. Plant layout and positioning of machinery
7. List of hazards at each process step
Process
step
Nature of
hazard
Hazard Control measure
Grinding Physical Metal Use of magnet sieve

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8. Hazard Analysis processes
Seve
rity
Likeli
-
hood.
Impact Signific. HACCP
Team
recm
Process step Hazard
Grinding P 3 2 High S CCP
Mixing
Etc….

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Risk Assessment Table
Likelihood
of
occurrenc
e
Severity (Level of control)
1 (Low) 2 (Medium) 3 (High)
1
(Remote)
1 2 3
2 (Low) 2 4 6
3
(Medium)
3 6 9
4 (High) 4 8 12

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Risk Assessment
Decisions made at a certain level of R,
If R is 1- 2 Negligible (NS)----------PRP
3-4 Minor impact (NS)-------OPRP
6- 9 Major impact (S)……….CCP
12- Severe impact (S)……….CCP

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S- Determine where to control the hazards
NS- Controlled at this step and records kept
Hazard Analysis involves Risk Assessment
Risk –Estimation of Hazard occurrence extent
Risk is a function of Likelihood of hazard occurrence and
control level (severity level)
R=L×C(S)

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Risk Assessment- Impact
R SEVERITY POSSIBLE CONSQUENCES RMKS
1 Negligible Unnoticed PRP
2 No impact Will go unnoticed PRP
3 Minor
impact
Irritate customer or boss OPRP
4 Signif.
impact
Formal complaint, breach of
trust
OPRP
6 Major
impact
Loss of customer acc,damage
company image
CCP
9 Major
impact
May lead to considerable
material/financial loss or
litigation
CCP
12 Severe
impact
Death/ business closure CCP

ISO 22000:2018
2
Issue : Apr 2020
Risk Assessment in Feed Production process
Process
Step
Hazard Critical
Limit
Prob
able
level
Contr
Level
Risk Level
Ingredi
ents
Loading
Foreign
matter
-Nil 2 1
2
2 (PRP)
2 (PRP)
Grindin
g
-Foreign
matter
-Nil 2 2 4 (OPRP)

ISO 22000:2018
2
Issue : Apr 2020
Risk Assessment in the Feed Production process
Process
Step
Hazard Critical Limit Probab.
Level
Control
Level
Risk Level
Mixing. Chemical
-Metal
-Micro
personnel
-As per spec
- Nil
-As per spec
1
3
3
2
1
1
4 (OPRP)
3 (PRP)
3 (PRP)
Temperin
g
-Lubr oil
-Dust
-Person
micro
- MSDS
- Nil
-As per spec
3
2
3
1
1
1
3 (PRP)
2 (PRP)
3 (PRP)

ISO 22000:2018
2
Issue : Apr 2020
Risk Assessment in the Feed Production process
Process
Step
Hazard Critical
Limit
Probab
.level
ContrLe
vel
Risk
Level
Wareho
use
-Micro
-Hair,etc
Dust
≤104cfu/
ml
Nil
Nil
2
2
3
1
1
1
2 (PRP)
2 (PRP)
3 (PRP)

ISO 22000:2018
2
Issue : Apr 2020
9. Determine CCPs- Decision Tree
Process
step
Signfic.
hazard
Q1 Q2 Q3 Q4 Q5 CCP HACCP Team
Notes
Y Y N Y Y CCP Why CCP
Not
CCP
Hazard
control at
step……

ISO 22000:2018
2
Issue : Apr 2020
CCP CONTROL TREE
PROCESS STEP:
HAZARD: CAUSE:
HAZARD - BRAIN STORMING

8.5 Hazard control
8.5.2.4 Selection and categorization of control
measure(s)
8.5.2.4.1 Based on the hazard assessment, the
organization shall select an appropriate control
measure or combination of control measures that will
be capable of preventing or reducing the identified
significant food safety hazards to defined acceptable
levels.
ISO 22000:2018
2
Issue : Apr 2020

8.5 Hazard control
8.5.3 Validation of control measure(s) and
combinations of control measures
The food safety team shall validate that the selected
control measures are capable of achieving the intended
control of the significant food safety hazard(s).
This validation shall be done prior to implementation
of control measure(s) and combinations of control
measures to be included in the hazard control plan
ISO 22000:2018
2
Issue : Apr 2020

8.5 Hazard control
8.5.4 Hazard control plan (HACCP/OPRP plan)
8.5.4.1 General
maintain a hazard control plan.
The hazard control plan shall be maintained as
documented information and shall include the
following information for each control measure at
each CCP or OPRP:
ISO 22000:2018
2
Issue : Apr 2020

8.5 Hazard control
a) food safety hazard(s) to be controlled at the CCP
or by the OPRP;
b) critical limit(s) at CCP or action criteria for
OPRP;
c) monitoring procedure(s);
d) correction(s) to be made if critical limits or
action criteria are not met;
e) responsibilities and authorities;
f) records of monitoring
ISO 22000:2018
2
Issue : Apr 2020

ISO 22000:2018
2
Issue : Apr 2020
ISO 22000:2018
2
Issue : Apr 2020
HACCP CONTROL
PROCESS STEP HAZARD
CCP NO. CRITICAL LIMTS
PREVENTIVE
(CONTROL)
MEASURE
MONITORING
PROCED. FREQU.
CORRECTIVE
ACTION
RESPONSIBILITY

ISO 22000:2018
2
Issue : Apr 2020
Example Feed Production
Ingredients Loading
Crushing
Mixing
Conditioning
Pelleting
Cooling
OPRP
CCP
Metal Detector

ISO 22000:2018
2
Issue : Apr 2020
Example :Critical Control Point
Any point, step or procedure at which control can be applied
to prevent, eliminate or reduce a hazard to an acceptable
level.
Mixing and grinding (metal contaminants)- magnet sieve-
oPRP
Pelleting (micro contaminants) – Right extr. Temps- oPRP
Metal detection ( 1.2mm Fe, 1.5mm non-Fe, 1.8mm S/steel
prevented (by operator) at primary wrapping, rope sizing-
CCP

8.5 Hazard control
8.5.4.2 Determination of critical limits and action criteria
Critical limits at CCPs and action criteria for OPRPs shall be
specified.
The rationale for their determination shall be maintained as
documented information. (see decision tree and risk
assessment table)
Critical limits at CCPs shall be measurable. Conformance with
critical limits shall ensure that the acceptable level is not
exceeded.
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.
ISO 22000:2018
2
Issue : Apr 2020

8.5 Hazard control
. Establish Critical Limits
A value of physical, chemical or biological
nature which separates acceptability from
unacceptability.
CL indicate absolute tolerance for safety. Critical
limits are not necessarily equal to existing
processing parameters.
Criteria often used include measurements of
temperature, time, moisture level, pH,
activity of water, available chlorine, sensory
parameters.
ISO 22000:2018
2
Issue : Apr 2020

8.5 Hazard control
ISO 22000:2018
2
Issue : Apr 2020
DISPLAY CRITICAL LIMITS NEXT TO CCP’s
> PUBLISHED DATA > EXPERIMENTAL DATA
> EXPERT ADVICE > MATH. MODELLING
--------------------------------------------------------------------
INDICATE ABSOLUTE TOLERANCE FOR SAFETY
CRITICAL LIMITS NOT NECESSARILY EQUAL TO EXISTING
PROCESSING PARAMETERS
HOW TO SET CRITICAL LIMITS

8.5 Hazard control
8.5.4.3 Monitoring systems at CCPs and for OPRPs
At each CCP, a monitoring system shall be established
for each control measure or combination of control
measure(s) to detect any failure to remain within
the critical limits.
The system shall include all scheduled measurements
relative to the critical limit(s).
ISO 22000:2018
2
Issue : Apr 2020

8.5 Hazard control
ISO 22000:2018
2
Issue : Apr 2020
CONTINOUS MONITORING
CRITICAL LIMIT
UCL
TARGET LEVEL
LCL
TIME
CRITICAL LIMIT
AVE TEMP
UNACCEPTABLE DEVIATION (CRITICAL DEFECT)
NORMAL TEMP

8.5 Hazard control
8.5.4.4 Actions when critical limits or action criteria are not
met
The organization shall specify corrections (see 8.9.2) and
corrective actions (see 8.9.3) to be taken when critical limits
or action criterion are not met and shall ensure that:
a) the potentially unsafe products are not released (see
8.9.4);
b) the cause of nonconformity is identified;
c) the parameter(s) controlled at the CCP or by the OPRP is
(are) returned within the critical limits or action criteria;
d) recurrence is prevented.
ISO 22000:2018
2
Issue : Apr 2020

ISO 22000:2018
2
Issue : Apr 2020
PURPOSE:
The purpose of this workshop is to practice using an appropriate framework
in conducting hazard analysis and drafting a HACCP Plan and an OPRP plan for
an organization
Choose one of these Processes/activities
Storage of perishable foods
Transportation of finished animal feeds
Purchasing of raw materials for catering
Using the formats provided, name at least four hazards that must be addressed
to ensure food safety and analyze/assess them.
Using the format provided prepare a draft HACCP Plan for the organization
Using the format provided prepare a draft OPRP plan for the organization
Workshop 9b: Hazard Analysis

8.5 Hazard control
8.5.4.5 Implementation of the hazard control
plan
The organization shall implement and maintain
the hazard control plan, and retain evidence of the
implementation as documented information.
Hazard Control Plan: HACCP PLAN OR OPRP PLAN
ISO 22000:2018
2
Issue : Apr 2020

ISO 22000:2018
2
Issue : Apr 2020
HACCP CONTROL
PROCESS STEP HAZARD
CCP NO. CRITICAL LIMTS
PREVENTIVE
(CONTROL)
MEASURE
MONITORING
PROCED. FREQU.
CORRECTIVE
ACTION
RESPONSIBILITY

8.5 Hazard control
ISO 22000:2018
2
Issue : Apr 2020
RECAP: Hazard control plan must contain, as a minimum,
the following information for all identified CCPs and
OPRPs:
 what food safety hazard are you controlling with this CCP or
OPRP
 what measure have you put in place to do so
 the critical limit/s or action criteria in place that can’t be
exceed
 how do you monitor this activity
 which corrections and corrective actions will be carried out
if critical limits or action criteria is not met
 who is responsible for this activity (defined responsibilities
and authorities)
 what records do you maintain as monitoring evidence

8.6 Updating the information specifying the
PRPs and the hazard control plan
Following the establishment of the hazard control plan, the
organization shall update the following information, if
necessary:
a) characteristics of raw materials, ingredients and product-
contact materials;
b) characteristics of end products;
c) intended use;
d) flow diagrams and descriptions of processes and process
environment.
The organization shall ensure that the hazard control plan
and/or the PRP(s) are up to date.
ISO 22000:2018
2
Issue : Apr 2020

The organization shall provide evidence that the specified
monitoring and measuring methods and equipment in use are
adequate for the monitoring and measuring activities related to
the PRP(s) and the hazard control plan.
The monitoring and measuring equipment used shall be:
a) calibrated or verified at specified intervals prior to use;
b) adjusted or re-adjusted as necessary;
c) identified to enable the calibration status to be
determined;
d) safeguarded from adjustments that would invalidate the
measurement results;
e) protected from damage and deterioration.
ISO 22000:2018
2
Issue : Apr 2020

Examples of monitoring and measuring methods and
equipment
• Air flow monitors
• Testing methods
• Temperature recorders
• pH meters
• Software
Can be verified: E.g software , methods
Calibration can be done at RSB Metrology department
ISO 22000:2018
2
Issue : Apr 2020

8.8 Verification related to PRPs and the hazard control plan
8.8.1 Verification
The organization shall establish, implement and maintain
verification activities. The verification planning shall define
purpose, methods, frequencies and responsibilities for the
verification activities.
The verification activities shall confirm that:
a) the PRP(s) are implemented and effective;
b) the hazard control plan is implemented and effective;
c) hazard levels are within identified acceptable levels;
d) input to the hazard analysis is updated;
e) other actions determined by the organization are
implemented and effective.
ISO 22000:2018
2
Issue : Apr 2020

8.8.2 Analysis of results of verification activities
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
ISO 22000:2018
2
Issue : Apr 2020

8.9 Control of product and process nonconformities
8.9.1 General
The organization shall ensure that data derived from
the monitoring of OPRPs and at CCPs are evaluated by
designated persons who are competent and have the
authority to initiate corrections and corrective
actions.
ISO 22000:2018
2
Issue : Apr 2020

8.9.2 Corrections
8.9.2.1 The organization shall ensure that when
critical limits at CCP(s) and/or action criteria for
OPRPs are not met, the products affected are
identified and controlled with regard to their use
and release.
The organization shall establish, maintain and update
documented information that includes:
a) a method of identification, assessment and
correction for affected products to ensure their proper
handling;
b) arrangements for review of the corrections carried
out.
ISO 22000:2018
2
Issue : Apr 2020

8.9.2.2 When critical limits at CCPs are not met,
affected products shall be identified and handled as
potentially unsafe products (see 8.9.4).
8.9.2.3 Where action criteria for an OPRP are not met,
the following shall be carried out:
a) determination of the consequences of that failure
with respect to food safety;
b) determination of the cause(s) of failure;
c) identification of the affected products and handling
in accordance with 8.9.4.
The organization shall retain results of the
evaluation as documented information
ISO 22000:2018
2
Issue : Apr 2020

8.9.2.4 Documented information shall be retained to
describe corrections made on nonconforming
products and processes, including:
a) the nature of the nonconformity;
b) the cause(s) of the failure;
c) the consequences as a result of the nonconformity.
ISO 22000:2018
2
Issue : Apr 2020

8.9.3 Corrective actions
The need for corrective actions shall be evaluated when critical
limits at CCP(s) and/or action criteria for OPRPs are not met.
The organization shall establish and maintain documented
information that specifies appropriate actions to identify and
eliminate the cause of detected nonconformities, to prevent
recurrence, and to return the process to control after a
nonconformity is identified.
These actions shall include:
a) reviewing nonconformities identified by customer and/or
consumer complaints and/or regulatory
inspection reports;
b) reviewing trends in monitoring results that can indicate
loss of control;
c) determining the cause(s) of nonconformities;
ISO 22000:2018
2
Issue : Apr 2020

d) determining and implementing actions to ensure that
nonconformities do not recur;
e) documenting the results of corrective actions taken;
f) verifying corrective actions taken to ensure that they are
effective.
The organization shall retain documented information on
all corrective actions
ISO 22000:2018
2
Issue : Apr 2020

8.9.4 Handling of potentially unsafe products
8.9.4.1 General
The organization shall take action(s) to prevent potentially
unsafe products from entering the food chain, unless it can
demonstrate that:
a) the food safety hazard(s) of concern is (are) reduced to the
defined acceptable levels;
b) the food safety hazard(s) of concern will be reduced to
identified acceptable levels prior to entering
the food chain; or
c) the product still meets the defined acceptable level(s) of the
food safety hazard(s) of concern despite
the nonconformity.
ISO 22000:2018
2
Issue : Apr 2020

8.9.4.2 Evaluation for release
Each lot of products affected by the nonconformity shall be evaluated.
Products affected by failure to remain within critical limits at CCPs
shall not be released, but shall be handled in accordance with 8.9.4.3.
8.9.4.3 Disposition of nonconforming products
Products that are not acceptable for release shall be:
a) reprocessed or further processed within or outside the organization
to ensure that the food safety hazard is reduced to acceptable levels;
or
b) redirected for other use as long as food safety in the food chain is
not affected; or
c) destroyed and/or disposed as waste.
Documented information on the disposition of nonconforming
products, including the identification of the person(s) with
approving authority shall be retained.
ISO 22000:2018
2
Issue : Apr 2020

8.9.5 Withdrawal/recall
The organization shall be able to ensure the timely
withdrawal/recall of lots of end products that have
been identified as potentially unsafe, by appointing
competent person(s) having the authority to initiate
and carry out the withdrawal/recall.
ISO 22000:2018
2
Issue : Apr 2020

8.9.5 Withdrawal/recall
Withdrawn/recalled products and end products still in stock
shall be secured or held under the control of the organization
until they are managed in accordance with 8.9.4.3.
The cause, extent and result of a withdrawal/recall shall be
retained as documented information and reported to the top
management as input for the management review (see 9.3).
The organization shall verify the implementation and
effectiveness of withdrawals/recalls through the use of
appropriate techniques (e.g. mock withdrawal/recall or practice
withdrawal/recall) and retain documented information.
ISO 22000:2018
2
Issue : Apr 2020

ISO 22000:2018
2
Issue : Apr 2020
FOR TRAINING PURPOSES ONLY MMC
Nonconforming product/process (name) :
Internal (department) External (customer name and address)
Reported by: Time Date:
Nonconforming report (and causes of failure)
Correction: (Retained/Released/Destroyed/Rework/Recalled/Withdrawn/other (please tick)
By: : Signed: Date:
Corrective Action (root causes to prevent occurrence):
Date:
Signed:
Action Review
Signed: Date:
Authorised person comment's
Signed: Date:

ISO 22000:2018
2
Issue : Apr 2020
1. In groups of 3-5 members, refer the scenario below :
XYZ plc transports and stores various Perishable Food products. In the despatch
area the Supervisor was reviewing the materials released to the customers and
noticed that some of the paper cartons stuffed with Food products (P.O. Number
2020/007) which was kept on three pallets and was marked ‘ready for the dispatch’,
did not have the following marked on the boxes:
 Lot number/Batch No.
 Weight.
 Address
 Expiry date
Work instructions WI 001 requires that the above-mentioned information must be
printed on the paper sacks for all Perishable Food d products.
2. Use the format and suggest the nature of the nonconformity, the cause(s) of the
failure and the consequences as a result of the nonconformity
Exercise 5: Non –conforming product

Clause 9. Performance evaluation
9.1.
9.2.
9.3.
Monitoring, measurement ,
analysis and evaluation
Internal Audit
Management Review
ISO 22000:2018
2
Issue : Apr 2020

9.1 Monitoring, measurement, analysis and evaluation
The organization shall determine:
a) what needs to be monitored and measured;
b) the methods for monitoring, measurement, analysis and evaluation,
as applicable, to ensure valid results;
c) when the monitoring and measuring shall be performed;
d) when the results from monitoring and measurement shall be
analysed and evaluated;
e) who shall analyse and evaluate the results from monitoring and
measurement.
The organization shall retain appropriate documented
information as evidence of the results.
1/21/2021
ISO 22000:2018
2
Issue : Apr 2020

9.1.2 Analysis and evaluation
The organization shall analyse and evaluate appropriate data and
information arising from
monitoring and measurement, including the results of verification
activities related to PRPs and the hazard control plan (see 8.8 and
8.5.4), the internal audits (see 9.2) and external audits.
The analysis shall be carried out in order to:
a) confirm that the overall performance of the system meets the
planned arrangements and the food safety management system
requirements established by the organization;
1/21/2021
ISO 22000:2018
2
Issue : Apr 2020

9.1.3 Analysis and evaluation (contd.)
b) identify the need for updating or improving the food safety
management system;
c) identify trends which indicate a higher incidence of
potentially unsafe products or process failures;
d) establish information for planning of the internal audit
programme related to the status and importance of areas to
be audited, and
e) provide evidence that any corrections and corrective actions
that have been taken are effective.
The results of the analysis and any resulting activities shall be
retained as documented information and shall be reported to
top management and used as input to the management review
(see 9.3) and the updating of the food safety management
system (see 10.2).
1/21/2021
ISO 22000:2018
2
Issue : Apr 2020

9.2 Internal audit
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 this International Standard;
b) is effectively implemented and maintained.
1/21/2021
ISO 22000:2018
2
Issue : Apr 2020

ISO 22000 Clauses Requirements and Documentation training ISO 22000 RS 184 HACCP

ISO 22000 Clauses Requirements and Documentation training ISO 22000 RS 184 HACCP

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