ISO 22000-2018- international standars organization.pdf

ISO 22000:2018

1. Mahmoud Yosry
1
Food Safety Management System
ISO 22000 : 2018

2. 2
Your Trainer
Mahmoud Yosry

3. Jhon Dee / General Manager
1.Name
2. Background
3.Job Title
5.Why you come to this
course ?
4.Experince
3Mahmoud Yosry

4. 4
Outline PDCA Approaches at Management & Operational Level
Comprehending ISO 22000:2018 Requirements:
Implementing a Food Safety Management System (FSMS)
Learning Objectives
The origin & purpose of Food Safety Management System
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5. MODULE I: THE ORIGIN & PURPOSE OF FOOD SAFETY
MANAGEMENT SYSTEM
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6. 6Mahmoud Yosry
International HACCP
Alliance formed
1994
BRC Formed
1998
GFSI Formed
2000
IFS Formed
2003
Foundation of food safety
certification formed
2004
FSMS ISO 22000 1
st

edition
2005
FSMS ISO 22000 2
nd

edition
2018

7. 7
❑(FSMS) is a collaborative and systematic approach to effectively manage food safety risks. FSMS helps companies to improve food safety
performance continually. FSMS also provides a framework for companies to comply food safety ordinances, regulations, state laws and other
obligations.
➢What is Food Safety Management System (FSMS)?
➢Food Safety Management System (FSMS) Principle?
Interactive
communication
System Approach
Prerequisite “PRPs”
Program
HACCP principle
1. Customer Focus2. Leadership3. Engagement of People4. Process Approach5. Improvement6. Evidence Based
Decision Making
7. Relationship
Management
Control Food Safety HazardsSystem management
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The same 10 clause titles for
management systems
High Level
Structure
Annex SL
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0 Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Context of the organization
4.1 Understanding of the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the FSMS
4.4 FSMS & its processes
5 Leadership
5.1 Leadership and commitment
5.2 Food Safety Policy
5.2.1 Establishing Food Safety Policy
5.2.2. Communicating the food safety policy
5.3 Organizational roles, responsibilities and authorities
6 Planning
6.1 Actions to address risks and opportunities
6.2 Objectives of FSMS and planning to achieve them
6.3 Planning of Changes
7 Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
8 Operation
8.1 Operational planning and control
8.2 PRPs
8.3 Traceability
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 & process nonconformities
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review
10 Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
Annex A:Cross reference between the Codex HACCP and ISO 22000:
Annex B: Comparison of ISO/DIS 22000 Versus ISO 22000:2005
Bibliography

10. 10
PDCA
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12. MODULE 2: CONTEXT OF THE ORGANIZATION
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4 Context of organization
4 Context of
organization
4.1 Understanding
the organization
and its context
4.2
Understanding
the needs and
expectations of
interested
parties
4.3 Determining
the scope of
FSMS
4.4
FSMS & its
processes
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4.1 Understanding the organization and its context
4 Context of organization
The organization shall determine external and
internal issues ;
relevant to its purpose and
That affect its ability to achieve the intended
results(s) of its FSMS
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15. 4.2 Understanding the needs and expectations of interested parties
Who are the relevant parties ?? , What are there requirements ??
4 Context of organization
The organization shall determine:
the other interested parties, in addition to workers, that
are relevant to the FSMS;
the relevant needs and expectations (i.e. requirements)
of the interested parties of FSMS;
which of these needs and expectations are or could
become legal requirements and other requirements.
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When determining this scope, the organization
shall:
a) consider the external and internal issues
referred to in 4.1;
b) take into account the requirements referred
to in 4.2
The organization shall determine the
boundaries and applicability of the FSMS to
establish its scope..
4.3 Determining the scope of the FSMS
4 Context of organization
FSMS
Food safety management system shall include the activities, processes, products services that can have an influence on the
food safety of its end products.
The scope shall be available as documented information
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4.4 FSMS & its processes
4 Context of organization
The organization shall establish, implement, maintain and
continually improve a FSMS, including the processes needed
and their interactions, in accordance with the requirements
of this document.
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5 Leadership
5 Leadership
5.1
Leadership and
commitment
5.2
Food Safety
Policy
5.3 Organizational
roles,
responsibilities
and authorities
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5.1 Leadership and commitment
The purpose of these requirements is to
demonstrate leadership and commitment
by leading from the top.
Top management now in FSMS has greater
involvement in the management system as a
leader.
5 Leadership
Taking
accountability of
Effectiveness of
the FSMS
Ensure Policy &
Objectives in
place
Ensure FSP & FS
objectives are
compatible with
the context of
the organization
Ensure the
integration of
FSMS with
business
processes
Mahmoud Yosry

20. 5.2 Food Safety Policy
5 Leadership
is appropriate to the purpose and
context of the organization
Provides a framework for setting and
reviewing FSMS objectives
Includes a commitment to continual
improvement of FSMS
Includes a commitment to satisfy
applicable food safety requirements
Address internal & external
communication
Address the needs of competences
related to food safety
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5.3 Organizational roles, responsibilities and authorities
5 Leadership
Top management shall ensure that
❖ the responsibilities and authorities for relevant roles are assigned and communicated understood within the
organization.
Top management shall assign the responsibility and authority for:
❖ ensuring that the FSMS conforms to the requirements of this document;
❖ reporting on the performance of the FSMS to top management;
❖ appointing the food safety team and the food safety team leader;
❖ designating persons with defined responsibility and authority to initiate and document action(s)..
The food safety team leader shall be responsible for:
❖ensuring the FSMS is established, implemented, maintained and updated;
❖managing and organizing the work of the food safety team;
❖ensuring relevant training and competencies for the food safety team (7.2);
❖reporting to top management on the effectiveness and suitability of the FSMS
❖All persons shall have the responsibility to report problem(s) with regards to the FSMS to identified person(s)
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6 Planning
6 Planning
6.1
Actions to
address risks
and
opportunities
6.2
Food Safety
objectives and
planning to
achieve them
6.3
Planning of
changes
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Determine the risks and opportunities that need to be addressed to:
❖ give assurance that the FSMS can achieve its intended result(s);
❖ enhance desirable effects;
❖ prevent, or reduce, undesired effects;
❖ achieve continual improvement.
Determination of risks and shall take into account:
❖ hazards
❖ Legal requirements and other requirements
❖ Planned Changes
6.1.2 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;
❖ evaluate the effectiveness of these actions.
6.1.3 The actions taken by the organization to address risks and opportunities shall be proportionate to:
❖ the impact on food safety requirements;
❖ the conformity of food products and services to customers;
❖ requirements of interested parties in the food chain.
6.1 Actions to address risks and opportunities
6 Planning
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6.2.1 FSMS objectives
❖ establish FSMS objectives at relevant functions and levels
❖ be consistent with the Food safety policy;
❖ be measurable (if practicable) or capable of performance evaluation;
❖ take into account:
❖ Applicable food safety requirements including customer requirements;
❖ be monitored;
❖ be communicated;
❖ be updated as appropriate.
6.2.2 Planning to achieve FSMS objectives
When planning how to achieve its FSMS objectives, 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, including indicators for monitoring;
The organization shall retain documented information on the FSMS objectives
6.2 Objectives of FSMS and planning to achieve them
6 Planning
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6.3 Planning of changes
6 Planning
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 the:
❖ purpose of the changes and their potential consequences;
❖ continued integrity of the FSMS;
❖ availability of resources to effectively implement the changes;
❖ allocation or re-allocation of responsibilities and authorities
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7 Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication/Information
7.5 Documented information
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ThereshouldbeadequateresourcestoensureeffectivenessoftheIMS.
Resourceconsiderationsnowinclude:
▪internalresources
▪externalproviders
▪people
▪monitoringandmeasuringresources
▪organizationalknowledgerequiredtoensuretheprocessesprovide
conformingproductsandservices
7.1 Resources
7 Support
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The organization shall determine, provide and maintain the infrastructure
necessary for the operation of its processes and to achieve conformity of
products and services.
NOTE Infrastructure can include:
a)buildings and associated utilities;
b)equipment, including hardware and software;
c)transportation resources;
d)information and communication technology
7.1.3 Infrastructure
7 Support
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7.1.4 Environment for the operation of processes (QMS)
7 Support
suitable
environment
social
psychological
physical
The organization shall determine, provide
and maintain the environment necessary
for the operation of its processes and to
achieve conformity of products and
services.
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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 FSMS by using
externally developed elements of a FSMS, including PRPs, the hazard analysis 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 to the processes and products of the organization by the food safety team;
d) implemented, maintained and updated as required by this document;
e) retained as documented information.
7.1.6 Control of externally provided processes, products or services
Retain documented information of these activities and any necessary actions as a result of the evaluations and re-
evaluations.
7 Support
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7.2 Competence
Competence
is the ability to do something successfully. Retain evidence
Acquire competence
Ensure competence
Determine competence needed
7 Support
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The organization shall ensure that
persons doing work under the
organization’s control are aware of:
7.3 Awareness
7 Support
policies
objectives
Contributions
Implication
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The organization shall determine the internal and external communications relevant to the integrated
management system
7.4 Communication / & Information
7 Support
What ?
When
?
With
whom
?
How ?Who ?
7.4.2 Internal Communication
7.4.3External Communication
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7.5 Documented information
7.5.3.2 For the control of documented information, the organization
shall address the following activities, as applicable:
7 Support
Distribution, access, retrieval and use
Storage, preservation
Control of changes
Retention and disposition
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7.5 Documented information
7 Support
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8 Operation
8.1 Operational Planning Control
8.2 Prerequisite programs PRPs
8.3 Traceability System
8.4 Emergency preparedness and response
8.5 Hazard Control
8.6 Updating the information specifying the PRPs and
hazard control plan
8.7 Control of monitoring and measuring
8.8 Verification related to PRPs and the hazard control
plan
8.9Control of product and process nonconformities
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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) b) implementing control of the processes in accordance with the criteria;
c) 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).
8.1 Operational Planning & Control
8 Operation
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PRPs
Program
Constriction
Layout of
buildings
Supplies of
utilities
Pest Control
Stabilities off
equipment
Supplier
assurance
process
Handling of
product
Cleaning &
Disinfecting
Prevention
of cross
contaminati
on
Personal
Hygiene
Product
information
8 Operation
8.1 PRPS Programme
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8. Operation
8.3 Traceability :
The traceability system shall be able to uniquely identify incoming material from the suppliers and the
initial
distribution route of the end product.
When establishing and implementing the traceability system, the following shall as a minimum be
considered:
❖the relation of lot of received materials, ingredients and intermediate products in relation to the end
products;
❖reworking of materials/products;
❖distribution route of the end product;
❖compliance with statutory/regulatory and customer requirements .
❖ Documented information as evidence of the traceability system shall be retained for a defined period. This includes as a
minimum shelf‐life of the end product. The organization shall verify and test the effectiveness of the traceability system.
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8.4 Emergency preparedness and response
❖ Documented information shall be established and maintained to manage these situations and
incidents.
8.4.2 Handling of emergencies and incidents
The organization shall:
a) respond to actual emergency situations and incident by:
❖ complying with statutory/regulatory requirements;
❖ communicating internally;
❖ 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, in particular, after the occurrence of
any incident, emergency situation or tests.
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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:
applicable statutory, regulatory and customer requirements; the organization’s products, processes and
equipment; food safety hazards relevant to the FSMS.
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Updating Information Specifying PRPs and Hazard Control Plan (Clause - 8.6)
Following the establishment of the hazard control plan, the food organization must update the following
information, if necessary:
• Characteristics of raw materials, ingredients and product-contact materials
• Characteristics of end products
• Intended use
• Flow diagrams and descriptions of processes and process environment.
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•Control of monitoring and measuring (Clause - 8.7)
The monitoring and measuring equipment used must be:
• 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.
The results of calibration and verification must be retained as documented information. The calibration
of all the equipment must be traceable to international or national measurement standards where no
standards exist, the basis used for calibration or verification must be retained as documented
information.
The food organization must assess the validity of the previous measurement results when the
equipment or process environment is found not to conform to requirements. The food organization
must take appropriate action in relation to the equipment or process environment and any product
affected by the non- conformance.
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•Control of Product and Process Nonconformities (Clause - 8.9)
•The food organization must make sure 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.
The food organization must make sure that when critical limits at CCPs
and/or action criteria for OPRPs are not met, the products affected are
identified and controlled with regard to their use and release.
The food organization must establish, maintain and update documented
information that includes:
• a method of identification, assessment, and correction for affected
products to ensure their proper handling
• Arrangements for review of the corrections carried out.
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9 Performance evaluation
9.1.3 – Analysis and Evaluation
Evaluation of compliance overall performance of the system meets the planned
9.1 Monitoring, measurement, analysis and performance evaluation
legal and other requirements Compliance, activities and operations related to
identified hazards, risks and opportunities; FSMS objectives Progress;,
effectiveness of operational and other controls;
9 – Performance Evaluation
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9.2 Internal audit
The organization shall conduct internal audits at planned intervals to provide
information on whether the quality management system:
a)conforms to:
1)the organization's own requirements for its quality management system;
2) the requirements of this International Standard;
b) is effectively implemented and maintained.
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9.3 Management review
Decisions &
actions
Top management shall
review the organization’s
FSMS, at planned
intervals, to ensure its
continuing suitability,
adequacy, effectiveness
and alignment with the
strategic direction of the
organization.
The status of
actions from
previous
management
reviews
Changes in
external &
internal
issues
relevant to
the FSMS
Information on the performance and
effectiveness of the FSMS, including
trends. In: Customer satisfaction,
Meeting quality objectives, Process
performance, N.C. & C.A., monitoring
& measuring results, audit, the
performance of external providers
The
effectiveness
of actions
taken to
address risks
and
opportunities
The
adequacy
of
resources
Opportunities
for
improvement
Management review inputs
Management review outputs
• opportunities for improvement;
• any need for changes to the QMS
• resource needs.
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10 Improvement
10.1 General
10.2
Nonconformity
and corrective
action
10.3 Continual
improvement
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10.1 General
10 Improvement
Determine and select opportunities
for improvement
Improve products and services to meet
known and predicted requirements
Correcting, preventing or reducing
undesired effects
Improve the performance and
effectiveness of the QMS
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NCMR, CAR
React
Take Action,
Control, Correct
Deal with it
Evaluate
Action for
Cause
Review the
NCMR
Determine
Cause
Potential for
similar NC
occur
Implement
Action Needed
Review for
effectiveness
Update risks &
opportunities, if
necessary
Make changes to
QMS, if necessary
10.2 Nonconformity and corrective action
Mahmoud Yosry

51. THANKS
52Mahmoud Yosry