INTRODUCTION “FOOD SAFETY

MANAGEMENT SYSTEM”
ISO 22000:2018

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Objectives of the day
This briefing will :
 Understand the basic concept of a Food Safety
Management System
 Interpret
the ‘High Level Structure’ approach to
management systems
 Review the intent of ISO 22000:2018

 Lay a foundation of knowledge food Safety management

system implementation based on ISO
22000:201822000:2018
 Understand the ISO 22000:2018 certification process
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FOOD SAFETY MANAGEMENT
SYSTEM OVERVIEW

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Food safety management systems —
Requirements for any organization in the
food chain.
(ISO 22000:2018)

 A set of requirements for a Food Safety

Management System (FSMS)
 It was developed to fill the need for a worldwide
Food Safety Standard

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Management System Standards
Common attributes of management systems include:

• Policies and planning

• Goals and objectives

• Leadership responsibilities and authorities

• Process approach and managing risk

• Performance evaluation

• Monitoring and improvement

High level structure enables integration of

management systems
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High level structure

 A new common format has been developed for use in
all management system standards:
 standardised core text and structure for multiple ISO
management systems for integration
 standardised core definitions
Organisations implementing multiple
management systems (e.g. quality, environmental,
information security) can achieve better
integration and easier implementation

The high level structure and common text is public information and can be found in
Annex SL of the www.iso.org/directives

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 Annex SL – How it works

Annex SL Discipline
Discipline
Common Specific
Specific
Structure Standard
Standard
Terms and (ISO9000)
(ISO22000)
Text

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 Key Change to
ISO 22000:2018

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Change due to the adoption of HLS
 Business Context and interested parties
 Strengthened emphasis on leadership and
management commitment
 Risk management
 Strengthened focus on objectives as drivers for
improvements
 Extended requirements related to communications
 Less strict requirements for a food safety manual

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Other changes that are specific to
ISO 22000 and food safety management
 The PDCA cycle
 The scope now specifically includes animal food:
 Some important changes in the definitions:
 Communicating the food safety policy.
 Food Safety Management System Objectives:
 Control of externally-provided processes, products
or services

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Introduction, Scope, Normative
References, & Terms and
Definitions

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 Overview
The potential benefits to an organization of implementing a
FSMS based on this document are:
a) the ability to consistently provide safe foods and products
and services that meet customer and applicable statutory
and regulatory requirements;
b) addressing risks associated with its objectives;
c) the ability to demonstrate conformity to specified FSMS
requirements

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 Overview
FSMS key elements:
 interactive communication;
 system management;
 prerequisite programmes;
 hazard analysis and critical control point
(HACCP) principles

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 Clause 1 - Introduction
The management principles are:
 customer focus;
 leadership;
 engagement of people;
 process approach;
 improvement;
 evidence-based decision making;
 relationship management.

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 Clause 1 : Scope
a. to plan, implement, operate, maintain and update a FSMS providing
products and services that are safe, in accordance with their intended
use;
b. to demonstrate compliance with applicable statutory and regulatory
food safety requirements;
c. to evaluate and assess mutually agreed customer food safety
requirements and to demonstrate conformity with them;
d. to effectively communicate food safety issues to interested parties
within the food chain;
e. to ensure that the organization conforms to its stated food safety
policy;
f. to demonstrate conformity to relevant interested parties;
g. to seek certification or registration of its FSMS by an external
organization, or make a selfassessment or self-declaration of
conformity to this document.
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 Clause 2 ; 3
a. Normative Reference
b.Term and Definition

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Section 4 - Context of the
Organization

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 What’s in Section 4 - Context of the
Organisation
This section is aimed at
 4.1 Understanding the organisation
providing a key insight into
and its context
the organisation - why the
 4.2 Understanding the needs and
organisation is here.
expectations of interested parties
 4.3 Determining the scope of the
food safety management system
It requires that you define
the ‘external and internal
 4.4 Food Safety management system
issues’ that are relevant
to your purpose
Unless you define these areas how will you be able to carry
out a meaningful risk assessment which will then form the
basis of all of your controls?
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 INTERNAL
STRENGTHS :
 Capabilities
 Resources Including Asset and people
 Competitive Advantage
 Data, Knowledge and experiences advantage
 Financial Reserves
 Processes or IT System driving value
 Market Research abilities
Weakness :
 Lack of capabilities
 Unfocused competitive strength
 Deadline, pressure and time limits
 Cash Drain or cash limitations
 Supply Chain continuity and delivery issues
 Inefficient management structure and lack
of succession planning
 Business reputation, reach or awareness
level issue.
EXTERNAL
Opportunities
 Development in technology and innovation
 New or better target markets
 New Partnership and contract
 Business or new product development
 Industry, market and lifestyle trends
 Global influences and import / export
 Economics of scale and production volumes
Risks / Threat :
 New legislation regulation
 Political, environment and economical effect
 Development in the IT and Communication
Industry
 Loss of resources and partners
 Change in market demands
 Shift in competitive atmosphere
 Unavoidable circumstance like natural
Calamities
Interested Parties’ Needs and
Expectations
1. Identify interested parties

2. Determine their key requirements

3. Evaluate the importance of each requirement

4.Establish a set of criteria

Outcome will inform the design and development

of the system

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 Discussion :
Context of the Organisation
An organisation is required to identify, analyse and
determine how external and internal issues can
impact its ability to achieve the expected outcomes
of its Food Safety Management System.

What are some of the potential internal

and external issues for the organizations
specified?

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Section 5 - Leadership

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What’s in Section 5 - Leadership
 5.1 Leadership and commitment

 5.2 Policy

 5.3 Organisational roles, responsibilities and authorities

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ISO 22000:2018 Requirement
ISO 22000:2018 places emphasis on top management engagement,
including the following clause example :

 Required to promote the process approach

 Policy and objective linked the organization strategic
 Required to ensure risk are managed
 Accountable for the effectiveness of the FSMS

Please note, a management representative is no longer explicitly

mentioned

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 Discussion :
Leadership Requirements
Identify the aspects of leadership and commitment
expected to be demonstrated by management with
respect to the food Safety management system.

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Developing Policies
Role of policy documents is to:
 Translate principles into statements of intent
 Ensure compliance with applicable requirement
 includes a commitment to satisfy applicable food safety requirements,
including statutory and regulatory requirements and mutually agreed
customer requirements related to food safety
 Commitment to Continual Improvement of FSMS
 Guide the organization towards the achievement of its strategic plan
 Improve the management of risk

Quality Policy provides a framework and commitment to support

the organization’s food Safety management system
Roles, Responsibilities and authorities ;
Top Management shall assign the responsibility and
authority for ensuring:
 FSMS meet requirements
 Processes are delivering their intended outputs
 Reporting of the FSMS performance
 Promotion of the Customer Focus
 Integrity of the FSMS
Section 6 - Planning

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What’s in Section 6 - Planning
 6.1 Actions to address risks and opportunities

 6.2 Quality objectives and planning to achieve them

 6.3 Planning of changes

• Risk is the subject of an explicit requirement of the

standard
 The risks and opportunities identified will lead to
policies and objectives
 Clause 6 puts a great emphasis on the organisation’s
planning which is integral to the business
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ISO 22000:2018 Requirement
The Planning for the food safety management system , the organization
shall consider the issues referred to in 4.1 and the requirement referred to
in 4.2 and determine the risks and opportunities that need to be
addressed
a. Give assurance that food safety management system can be achieve
its intended result(s)
b. Prevent, or reduce, undesired effects
c. Achieve continually improve
The organization shall plan :
a. Action to address these risk and opportunities, and
b. How to :
1. Integrate and implement the actions into its food safety management
system processes (4.4), and
2. Evaluate the effectiveness of these actions
Any action taken to address risks and opportunities shall be
proportionate to the potential effects on conformity of goods and services
and customer satisfaction.
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 Discussion :
Risk Requirements
Understanding what the standard says about risk, taking
your own organisation as an example, come up with five
areas of greatest risk to your business, and how you
would take steps to mitigate these.

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Objectives and Planning to achieve them
The Objectives ;
 Relevant function and level
 Be consistent with the quality policy
 Take into account applicable requirement
 Be relevant to conformity of products and services
 Be monitored
 Be communicated
 Be updatedof the FSMS
Objectives and Planning to achieve them
When planning how to achieved its Objectives ;
 What will be done
 What resources will be required
 Who will be responsible
 When it will be completed
 How the result will be evaluated
Planning of change :
Determine the need of changes of the FSMS and shall
be in a planned manner ;
 The purpose of the change and their potential
consequences
 The integrity of the FSMS
 The availability of resources
 The allocation of reallocation of responsibilities and
authorities
Section 7 : Support

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What’s in Section 7 - Support
• This section includes -
 7.1 Resources resources, competence,
 7.2 Competence awareness, communication
& documented information
 7.3 Awareness

 7.4 Communication The support required to

 7.5 Documented information
meet the organisation’s
goals

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What’s in Section 7 - Support
 People
 Infrastructure
 Work Environment
Resources  Externally developed elements of
the food safety management
7.1 system
 Control of externally provided
processes, products or services
Documented
Information Competence
7.5 7.2
 Polices  Competency
 Procedures Requirement
 Records 7. Support  Evident
 Competency Record

Communication Awareness
 Internally & Externally 7.4 7.3  Controlled Conditions
 What - When  Contribution
 Who - How  Effectiveness

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 Discussion :
What, no documents?

What other means of communicating requirements

to the individuals performing the task can we use?

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Section 8 : Operation

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 What’s in Section 8 - Operation
 8.1 Operational planning and control • The section covers
those aspects of the
 8.2 Prerequisite programmes (PRPs)
business that result in
 8.3 Traceability system a product or service
 8.4 Emergency preparedness and response which form the basis
of the organisation
 8.5 Hazard control output
 8.6 Updating the information specifying the • Whatever is at the
PRPs and the hazard control plan heart of the
 8.7 Control of monitoring and measuring management system
‘The Business’ then
 8.8 Verification related to PRPs and the hazard this is what is covered
control plan in clause 8
 8.9 Control of product and process nonconformities

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Operation Planning and Control
Shall plan, implement and control the processes:
 Determine Criteria of the processes and
 Determine resources
 Determine Control
 Determine Documented information
Prerequisite Program
 Prerequisite Programs:
 Basic Conditions and activities that are
necessary to maintain a hygienic
environment throughout the food chain
Traceability system
 relation of lots of received materials,
ingredients and intermediate products to
the end products;
 reworking of materials/products;
 distribution of the end product.
Emergency Preparedness & Response
 Be prepared to respond to emergency situations
Prepare an emergency plan to address potential
situations:
Fire
Flood
Accidents
Contamination
Others...
Hazard Control
 Preliminary steps to enable hazard analysis
 Hazard analysis
 Validation of control measure(s) and combinations of
control measures
 Hazard control plan (HACCP/OPRP plan)
Updating the information specifying
the PRPs and the hazard control plan
 characteristics of raw materials, ingredients and
product-contact materials;
 characteristics of end products;
 intended use;
 flow diagrams and descriptions of processes and
process environment.
Control of monitoring and measuring
 calibrated or verified at specified intervals prior to use;
 adjusted or re-adjusted as necessary;
 identified to enable the calibration status to be
determined;
 safeguarded from adjustments that would invalidate
the measurement results;
 protected from damage and deterioration.
Verification related to PRPs and the
hazard control plan
 the PRP(s) are implemented and effective;
 the hazard control plan is implemented and effective;
 hazard levels are within identified acceptable levels;
 input to the hazard analysis is updated;
 other actions determined by the organization are
implemented and effective.
Control of product and process
nonconformities
 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.
Section 9 : Performance

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What’s in Section 9 – Performance
Evaluation
 9.1 Monitoring, measurement,
analysis and evaluation
 9.2 Internal audit
 9.3 Management review
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The process of determining what
to be monitored, measured,
analysed and evaluated will
enable the organisation to
determine ‘is the management
system suitable, adequate and
effective?’
Add to this internal audit and
management review and
everything is in place to fully
understand the benefits of a
food safety management
system
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Internal Audits
planned intervals
establish, implement and maintain
frequency, methods,
responsibilities, reporting, considering
objectives and importance customer
feedback, changes results of previous audits
audit criteria and scope select auditors
Effective
conduct audits to ensure objectivity and the
impartiality ensure results are reported to
Internal Audit
relevant management take necessary
Process
correction corrective actions without delay
retain documented information as evidence
of the implementation the program and
results.
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Management Reviews
review the organisation's food safety
management system , planned intervals,
ensure continuing suitability, adequacy,
effectiveness planned and carried out
considering actions from previous reviews
changes in external and internal issues
information on the quality performance,
+ including trends and indicators for
nonconformities and corrective actions
monitoring and measurement results audit
results customer satisfaction issues
concerning external providers adequacy of
resources process performance and
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conformity of products and services
planning to consider effectiveness of
actions taken to address risks and
opportunities new potential opportunities
for continual improvement
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 Discussion:
Performance Evaluation
How is an organisation required to monitor and
measure its quality performance?

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Section 10 : Improvement

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What’s in Section 10 - Improvement
• Corrective actions shall
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10..1 Nonconformity and corrective be appropriate to the
action effects of the
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10..2 Continual improvement nonconformities
 10.3 Update of the food safety
management system
encountered

• What about preventive action? Annex SL structure and

text for all management system standards does not include
a clause and specific requirements for “preventive action”
• This is because one of the key purposes of a formal
management system is to act as a preventive tool

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