IS/IS0 22000 : 2018

FOOD SAFETY MANAGEMENT SYSTEMS — REQUIREMENTS FOR

ANY ORGANIZATION IN THE FOOD CHAIN

1
 Introduction
• Food safety is related to the presence of food-borne hazards in
food at the point of consumption (intake by the consumer).
• As the introduction of food safety hazards can occur at any stage
of the food chain, adequate control throughout the food chain is
essential.
• Food safety is ensured through the combined efforts of all the
parties participating in the food chain.

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 FOOD SUPPLY CHAIN

Farming Retail &

and Processing Logistic Storage food
Agriculture Service

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 WHY FOOD SAFETY MANAGEMENT?
– Significant increase of illnesses caused by infected food in
both developed and developing countries.

– In addition to the health hazards, food-borne illnesses can

give rise to considerable economic costs covering
• medical treatment,
• absence from work,
• insurance payments
• legal compensation.

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 What is IS/ISO 22000

• Global standard for Food Safety Management

System
• Designed to enable organizations to control
food safety hazards along the food chain
• Applies to all types and sizes of organizations
participating in food chains

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 APPLICABILITY
The requirements of IS/ISO 22000:2005 are generic and are intended to be
applicable to all organizations in the food chain regardless of size and
complexity.
This includes organizations which are involved:
 directly in one or more steps of the food chain (such as, feed producers,
harvesters, farmers, food manufacturers, retailers, food services,
catering services, organizations providing cleaning and sanitation
services, transportation, storage and distribution services);
 indirectly in the food chain (for example, suppliers of equipment,
cleaning and sanitizing agents, packaging materials and other food
contact materials).

Food Safety Management System

 Key Changes
High Level Structure Risk based Approach
New Version follow
the same structure as 01 02 and ‘Hazard Control Plan’
rather than OPRP and/or
all other ISO HACCP Plan
Mananagement system
Standards Key Changes
to ISO
22000:2018
PDCA Cycle
clarified to one for Operations –
the FSMS and one clearer differences
for the principles
of HACCP
03 04 between
OPRPs and PRPs
CCPs,

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 System Management
Communication Evaluation
Management System

Prerequisites

POLICY

HACCP
Resources
Verification &
Process Management
Validation

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 FSMS PRINCIPLES
• adequate control throughout the food chain through interactive communication, system
management, prerequisite programmes and HACCP principles
• principles common to ISO management standards:

customer focus

Leadership

engagement of people

process approach

Improvement

evidence-based thinking

relationship management

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 Process approach

• adoption of process approach

• managing inter-related processes as a System
• recognition of role and position within the food chain is
essential to ensure effective communication
• PDCA cycle –see over.

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PDCA cycle at two levels

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 Prerequisite programs

ISO/TS 22002-1:2009, Food manufacturing

ISO/TS 22002-3:2011, Farming

ISO/TS 22002-2:2013, Catering

ISO/TS 22002-4:2013, Food packaging manufacturing

ISO/TS 22002-6:2016, Feed and animal food production

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Benefits of FSMS
Increased
international
acceptance of
food products
Helps to meet Reduces
applicable risk of
statuary & product/ser
regulatory vice liability
requirements claims

FSMS
conformance Satisfies
to customer
international contractual
standards requirements

Ensures safety
Greater health
of food
protection
products

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Common structure for MSS
1.Scope
2.Normative references
3.Terms and definitions
4.Context of the organisation
5.Leadership
6.Planning
7.Support
8.Operation
High
9.Performance evaluation
Level 10.Improvement
Structure

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 Section 4: Context of the Organisation

• Understanding organisation and its context (4.1)

Requirement: determine external and internal issues that are relevant to the
purpose of the organisation and that affect its ability to achieve the intended
outcome(s) of the FSMS.

• Understanding need and expectation of interested

parties (4.2)
Requirement: determine

(a) the interested partiesthat are relevant to the FSMS

(b) their relevant requirements

Food Safety Management System

 Section 4: Context of the Organisation
• Determining the scope of the FSMS(4.3)
determine the boundaries and applicability of the FSMS:
shall specify the products and services, processes and production site(s) that are included
in the FSMS and shall include the activities, processes, products or services that can have an
influence on the food safety of its end products

• Food safety management system (4.4.)

- establish, implement, maintain, update and continually improve a FSMS,
- including the processes needed and their interactions

Food Safety Management System

 Section 5: Leadership
• Leadership and commitment (5.1)
Top management shall demonstrate leadership and commitment with respect to the FSMS by ensuring :

a) that the food safety policy and the objectives of the FSMS are established and are compatible with the
strategic direction of the organization;

b) ensuring the integration of the FSMS requirements into the organization’s business processes;

c) ensuring that the resources needed for the FSMS are available;

d) communicating the importance of effective food safety management and conforming to the FSMS
requirements, applicable statutory and regulatory requirements, and mutually agreed customer
requirements related to food safety;

e) ensuring that the FSMS is evaluated and maintained to achieve its intended result(s)

f) directing and supporting persons to contribute to the effectiveness of the FSMS; g)

g) promoting continual improvement; and supporting other relevant management roles

Food Safety Management System
 Section 5: Leadership

• Food Safety Policy (5.2) Appropriate

to Purpose
Be
communic Provide
ated framework
within the for FSMS
organizati Objectives
on
Food
Safety
Be available policy Commit to
as shall
documented satisfy FSMS
requirements
information

Commit to Address
continual Communicati
improvement on
of FSMS

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 Section 5: Leadership
• Organizational roles, responsibilities and authorities (5.3)
Roles and responsibilities

Top-management Food Safety Team Leader All personnel

a) Responsibility for Implementation Ensuring that FSMS is established ,

of and Compliance with FSMS implemented , maintained and updated Shall be responsible to
report problem to
identified person

Managing and organizing work for food safety

team
b) Ensure that responsibility
and authority are assigned
and communicated.
Relevant Training and Competency and reporting
to top management

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Section 6: Planning
• Actions to address risks and
opportunities (6.1)
determine the risks and opportunities that
need to be addressed to-

- achieving intended results of the FSMS

- Enhance desirable effects
-preventing or reduce undesired effects, and
-preforming continual improvement of the
FSMS

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 Section 6: Planning
• The organization shall plan:(6.1.2)
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.
The actions taken by the organization to address risks and
opportunities shall be proportionate to (6.1.2):
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
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 Section 6: Planning

Consisted with Policy

• Objectives and planning to
Measurable achieve them (6.2)
The organization shall establish
Relevant to applicable Food objectives for the FSMS at relevant
Safety , statutory , regulatory
requirements functions and levels (6.2.1)

Objectives
Monitored
Shall be

Communicated

Updated

Documented

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 Section 6: Planning
• Planning of Changes (6.3)
When the organization determines the need for changes to the FSMS, including
personnel changes, the changes shall be carried out and communicated 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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 Section 7: Support
Awareness (7.3)
The organization shall ensure that all relevant persons doing work under the
organization’s control shall be aware of:

food objectives of
the FSMS
safety relevant to
policy their task(s)

their individual implications

contribution to of not
the
effectiveness conforming
and benefits of with the
FSMS FSMS

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 Section 7: Support
Communication (7.4)
The organization shall ensure that the requirement for effective communication is
understood by all persons whose activities have an impact on food safety

7.4.2 External communication

external customers Statutory and Other

organizations
providers and and/or regulatory that have an
contractors consumers authorities impact on FSMS

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 Section 7: Support
7.4.3 Internal communication
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;
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;
l) complaints and alerts indicating food safety hazards associated with the end product;
m) other conditions that have an impact on food safety

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 Section 7: Support
Documented information (7.5)

7.5.1 General

The organization’s FSMS shall include:

a) documented information required by this document;
b) documented information determined by the organization as being necessary
for the effectiveness of the FSMS;
c) documented information and food safety requirements required by statutory,
regulatory authorities and customers)

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 Section 7: Support
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

7.5.3 Control of documented information

7.5.3.1 Documented information required by the FSMS and by this document 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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 Section 8: Operations
Operational planning and control (8.1)
The organization shall plan, implement, review and control operational processes needed
to meet requirements of theFSMS:
- establishing criteria for the processes;
- implementing control of the processes in accordance with the criteria;
- keeping documented information to have confidence that processes have
been carried out as planned.

Prerequisite programmes (PRPs)(8.2)

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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 Section 8: Operations
PRP shall be (8.2.2)
appropriate to
implemented
the size and type
across the entire
of the operation
production
and the nature of
system
the products

appropriate to approved by the

the context
PRP food safety team

Shall
be
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 Section 8: Operations
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.

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;
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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 Section 8: Operations

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.

Food Safety Management System

 Section 8: Operations
8.4 Emergency preparedness and response
8.4.1 General

8.4.2 Handling of emergencies and incidents

The organization shall:
a) respond to actual emergency situations and incidents by:
1) ensuring applicable statutory and regulatory requirements are identified;
2) communicating internally;
3) communicating externally
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

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 Section 8: Operations
8.5 Hazard control

8.5.1 Preliminary steps to enable hazard analysis

8.5.1.1 General
8.5.1.2 Characteristics of raw materials, ingredients and product contact materials
8.5.1.3 Characteristics of end products
8.5.1.4 Intended use
8.5.1.5 Flow diagrams and description of processes
8.5.1.5.1 Preparation of the flow diagrams
8.5.1.5.2 On-site confirmation of flow diagrams
8.5.1.5.3 Description of processes and process environment

8.5.2 Hazard analysis

8.5.2.1 General

Food Safety Management System

 Section 8: Operations
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
8.5.2.2.2 The organization shall identify step(s) at which each food safety hazard can be
present, be introduced, increase or persist.
8.5.2.2.3 The organization shall determine the acceptable level in the end product of each food
safety hazard identified
8.5.2.3 Hazard assessment
8.5.2.4 Selection and categorization of control measure(s)

8.5.3 Validation of control measure(s) and combinations of control measures

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 and after any change therein.

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 Section 8: Operations
8.5.4 Hazard control plan (HACCP/OPRP plan)
8.5.4.1 General
8.5.4.2 Determination of critical limits and action criteria
8.5.4.3 Monitoring systems at CCPs and for OPRPs
8.5.4.4 Actions when critical limits or action criteria are not met
8.5.4.5 Implementation of the hazard control plan

Food Safety Management System

 Section 8: Operations
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.
.
8.7 Control of monitoring and measuring
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

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 Section 8: Operations
8.8 Verification related to PRPs and the hazard control plan
8.8.1 Verification
8.8.2 Analysis of results of verification activities

8.9 Control of product and process nonconformities

8.9.1 General
8.9.2 Corrections
8.9.3 Corrective actions
8.9.4 Handling of potentially unsafe products
8.9.5 Withdrawal/recall

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 Section 9: Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation –
9.1.1 General
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

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

Food Safety Management System

 Section 9: Performance evaluation
Internal audits (9.2)
9.1.1 Conduct internal audits at planned intervals whether the FSMS
(i) conforms to stated requirements of FSMS
(ii)is effectively implemented and maintained

9.2.2 The organization shall:

a) plan, establish, implement and maintain (an) audit programme(s),
b) define the audit criteria and scope
c) select competent auditors and conduct audits
d) ensure that the results of the audits are reported to the food safety
team and relevant management
e) retain documented information as evidence of
f) the implementation of the audit programme and the audit results; f)
make the necessary correction and take the necessary corrective action
g) determine if the FSMS meets the intent of the food safety policy

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 Section 9: Performance evaluation
Management review (9.3)

Input Output

• Status of action of previous

management reviews, • Decision and actions
• Change in external and related to continual
internal issues, improvement opportunities
• Information on • Any needs for updates and
performance and changes to FSMS including
effectiveness of the the resource needs and
management systems, revision in FSMS policy and
objectives.
• Adequacy of resources,
• Opportunity of
improvements

Food Safety Management System

 Section 10: Improvement
Non-conformity and corrective actions (10.1) –
actions required!
a) react to the nonconformity
b) evaluate the need for action to eliminate the cause(s) of the nonconformity
c) implement any action needed;
d) review the effectiveness of any corrective action taken;
e) make changes to the FSMS, if necessary

10.1.2 The organization shall retain documented information as evidence of:

a) the nature of the nonconformities and any subsequent actions taken;
b) the results of any corrective action

Food Safety Management System

 Section 10: Improvement
Continual improvement (10.2) - Suitability, adequacy, effectiveness of FSMS
- information derived from reports concerning:
- internal audits (9.2)
- management reviews (9.3)
- corrective measures (10.1)

Update of the food safety management system (10.3)

The updating activities shall be based on:
a) input from communication, external as well as internal
b) input from other information concerning the suitability, adequacy and effectiveness of
the FSMS;
c) output from the analysis of results of verification activities
d) d) output from management review

Food Safety Management System