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© Operational Excellence Consulting. All rights reserved.
© Operational Excellence Consulting. All rights reserved.
ISO 22000:2018
Awareness
© Operational Excellence Consulting. All rights reserved. 2
Learning Objectives
1.  Provide background knowledge of ISO 22000:2018
2.  Gain an overview of ISO 22000:2018 structure
3.  Understand the ISO 22000:2018 certification process
4.  Learn useful tips on handling an audit session
NOTE: As this is a PREVIEW, only selected
slides are shown. To download the complete
presentation, please visit:
http://www.oeconsulting.com.sg
© Operational Excellence Consulting. All rights reserved. 3
Contents
2	
3	
4	
ISO 22000:2018 Structure
ISO 22000 Certification Process
Handling an Audit Session
1	 Overview of ISO 22000:2018
© Operational Excellence Consulting. All rights reserved. 4
About ISO
§  Non-governmental organization (NGO) established in
1947, based in Geneva, Switzerland
§  Has a membership of 160 national standards institutes
from countries in all regions of the world
© Operational Excellence Consulting. All rights reserved. 5
Introduction to Food Safety
§  Current world food trade is valued at $300-400 billion
§  With the demand for food rising to meet the ever growing
world population, food safety is becoming, even more,
important
§  The reason why food safety has such an important role
in the manufacturing process is to ensure the products
delivered to consumers do not interfere with a person’s
health
§  Failing to comply to food safety regulations can result in
the transmission of foodborne illnesses
© Operational Excellence Consulting. All rights reserved. 6
The Food Supply Chain
FOOD
SUPPLY
CHAIN
Storage
Processing
Logistics
Farming &
Agriculture
Retail &
Food
Service
© Operational Excellence Consulting. All rights reserved. 7
More than
200
diseases are
spread
through food
Source: WHO
© Operational Excellence Consulting. All rights reserved. 8
Global Toll – Foodborne Diseases
§  2 million deaths occur every year from contaminated food or
drinking water
§  582 million cases of 22 different foodborne enteric diseases and
351,000 associated deaths
§  Salmonella Typhi, the most deadly of the enteric diseases agents,
was responsible for 52,000 deaths
§  The African region recorded the highest disease burden for enteric
foodborne disease, followed by South-East Asia
§  Over 40% people suffering from enteric diseases caused by
contaminated food were children aged under 5 years
Source: World Health Organization (WHO), April 2015
© Operational Excellence Consulting. All rights reserved. 9
What is ISO 22000?
§  ISO 22000 is a global standard
for Food Safety Management
Systems (FSMS)
§  Designed to enable
organizations to control food
safety hazards along the food
chain
§  Applies to all types and sizes
of organizations participating
in the food chain
© Operational Excellence Consulting. All rights reserved. 10
Key Changes to ISO 22000:2018
High Level
Structure
The new version of ISO
22000 will follow the
same structure as all
the other ISO
management system
standards.
Risk-based
Approach
The new standard will
now include a different
approach to
understanding risk.
Plan-Do-Check-Act
(PDCA) Cycle
The standard clarifies
the PDCA cycle, by
having two separate
cycles in the standard
working together: one
covering the
management system
and the other, covering
the principles of
HACCP.
The Operation
Process
A clear description is
given of the differences
between key terms
such as: Critical Control
Points (CCPs),
Operational
Prerequisite Programs
(OPRPs) and
Prerequisite Programs
(PRPs).
© Operational Excellence Consulting. All rights reserved. 11
Benefits to an Organization for Implementing
a Food Safety Management System
§  Preventive approach to food
safety
§  Conformance to legal and
regulatory requirements
§  Increase credibility and reputation
§  Improves customer satisfaction
§  Increase in profitability of the
company
© Operational Excellence Consulting. All rights reserved. 12
Advantages of Certification
§  Compliance with customer
requirements specifying
certification
§  Independent check of
conformity
§  Indicates an effective Food
Safety Management System
§  Worldwide recognition
§  Provides competitive advantage
§  Improves company image
© Operational Excellence Consulting. All rights reserved. 13
Overview of Annex SL
§  Although Annex SL is a framework for a generic
management system, it requires the addition of
discipline-specific requirements to make a fully functional
standard.
Annex SL
High-level
structure
Identical
core text
Common
definition
© Operational Excellence Consulting. All rights reserved. 14
The ISO 22000:2018 Structure is Aligned to the
Common Structure for MSS
1.  Scope
2.  Normative References
3.  Terms & Definitions
4.  Context of the Organization
5.  Leadership
6.  Planning
7.  Support
8.  Operation
9.  Performance Evaluation
10.  Improvement
© Operational Excellence Consulting. All rights reserved. 15
ISO 22000:2018 Approach is Based on the
Plan-Do-Check-Act (PDCA) Model
C
A D
P
Planning
(6)
Support (7) &
Operation (8)
Improvement
(10)
Performance
evaluation
(9)
Leadership
(5)
Scope of the food safety management system (4.3/4.4)
Intended outcomes of
the food safety
management system
Internal and
external issues
(4.1)
Needs and expectations
of workers and other
interested parties
(4.2)
Context of the organization
(4)
© Operational Excellence Consulting. All rights reserved. 16
The PDCA Cycle at the Two Levels
DO (FSMS)
8.  Operation
PLAN (FSMS)
4.  Context of the
organization
5.  Leadership
6.  Planning
7.  Support (including
control of externally
provided processes,
products or services)
CHECK (FSMS)
9.  Performance
evaluation
ACT (FSMS)
10.  Improvement
Organizational planning and control
ACT (food safety)
Updating of preliminary
information and documents
specifying the PRPs and the
hazard control plan
PLAN (food safety)
PRPs
Traceability System
Emergency preparedness & response
Hazard
analysis
Validation
of control
measures
Validation
planning
Hazard control plan
(HACCP/OPRP
plan)
Operational planning and control
CHECK (food safety)
Verification activities
Analysis of results of verification
activities
DO (food safety)
Implementation of the
PLAN (food safety)
Control of monitoring
and measuring
Control of product and
process nonconformities
© Operational Excellence Consulting. All rights reserved. 17
ISO 22000:2018 Clause Structure (4-10)
PLAN DO CHECK ACT
4. Context of the
organization
5. Leadership 6. Planning 7. Support 8. Operation 9. Performance
evaluation
10. Improvement
4.1 Understanding the
organization and its
context
5.1 Leadership and
commitment
6.1 Actions to address
risks and opportunities
7.1 Resources 8.1 Operational planning
and control
9.1 Monitoring,
measurement, analysis
and evaluation
10.1 Nonconformity and
corrective action
4.2 Understanding the
needs and expectations
of interested parties
5.2 Policy 6.2 Objectives of the
FSMS and planning to
achieve them
7.2 Competence 8.2 Prerequisite
programmes (PRPs)
9.2 Internal audit 10.2 Continual
improvement
4.3 Determining the
scope of the FSMS
5.3 Organizational roles,
responsibilities and
authorities
6.3 Planning of changes 7.3 Awareness 8.3 Traceability system 9.3 Management review 10.3 Update of the
FSMS
4.4 FSMS 7.4 Communication 8.4 Emergency
preparedness and
response
7.5 Documented
information
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
© Operational Excellence Consulting. All rights reserved. 18
2021
Full conformance
with the new
standard
Recertification
audits to new
standard
2018-
2021
2018
Transition to full
compliance
Published ISO
22000:2018
ISO 22000:2018
Certification Transition Timeline
Recertification
audits to new
standard
2019
Companies that are currently
certified to ISO 22000:2005
have to transition to the 2018
version within 3 years of the
publication of the new standard
2020
© Operational Excellence Consulting. All rights reserved. 19
ISO 22000:2018 Certification Process
Request for
Registration
Document
Review
Pre-assessment
The Registration
Audit
Take Corrective
Action
Registration
Decision
Certification &
Publicizing Your
Registration
Maintaining
Registration &
Surveillance
Audits
© Operational Excellence Consulting. All rights reserved. 20
Audit Findings
Minor Non-conformity
Observation
Major Non-conformity
© Operational Excellence Consulting. All rights reserved. 21
Auditee’s Conduct
§  Polite
§  Professional
§  Positive / Receptive
§  Sincere
§  Commitment
§  Formal but not overly serious
© Operational Excellence Consulting. All rights reserved. 22
Interacting with Auditors
§  Be honest and open
§  Recognize they may be experts
§  Realize they may not be subject
matter experts
§  Understand the purpose of the
meeting and review related records
prior to interviews
§  Turn mobile phones to silent mode
© Operational Excellence Consulting. All rights reserved. 23
Interacting with Auditors
§  Assume auditors are familiar with
your organization’s FSMS
§  Challenge auditors
§  Show more competence in ISO
22000
§  Argue internally
§  Express unfairness
§  Ask for solution
§  Fix non-conformities on the spot
© Operational Excellence Consulting. All rights reserved. 24
“From Farm to Plate,
Make Food Safe.”
© Operational Excellence Consulting. All rights reserved.
About		
Operational	
Excellence	Consulting
© Operational Excellence Consulting. All rights reserved. 26
About Operational Excellence
Consulting
§  Operational Excellence Consulting is a management
training and consulting firm that assists organizations in
improving business performance and effectiveness.
§  The firm’s mission is to create business value for
organizations through innovative operational excellence
management training and consulting solutions.
§  OEC takes a unique “beyond the tools” approach to enable
clients develop internal capabilities and cultural
transformation to achieve sustainable world-class excellence
and competitive advantage. For more information, please visit
www.oeconsulting.com.sg
© Operational Excellence Consulting. All rights reserved.
END OF PARTIAL PREVIEW
To download this presentation,
please visit:
www.oeconsulting.com.sg

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ISO 22000:2018 (FSMS) Awareness

  • 1. © Operational Excellence Consulting. All rights reserved. © Operational Excellence Consulting. All rights reserved. ISO 22000:2018 Awareness
  • 2. © Operational Excellence Consulting. All rights reserved. 2 Learning Objectives 1.  Provide background knowledge of ISO 22000:2018 2.  Gain an overview of ISO 22000:2018 structure 3.  Understand the ISO 22000:2018 certification process 4.  Learn useful tips on handling an audit session NOTE: As this is a PREVIEW, only selected slides are shown. To download the complete presentation, please visit: http://www.oeconsulting.com.sg
  • 3. © Operational Excellence Consulting. All rights reserved. 3 Contents 2 3 4 ISO 22000:2018 Structure ISO 22000 Certification Process Handling an Audit Session 1 Overview of ISO 22000:2018
  • 4. © Operational Excellence Consulting. All rights reserved. 4 About ISO §  Non-governmental organization (NGO) established in 1947, based in Geneva, Switzerland §  Has a membership of 160 national standards institutes from countries in all regions of the world
  • 5. © Operational Excellence Consulting. All rights reserved. 5 Introduction to Food Safety §  Current world food trade is valued at $300-400 billion §  With the demand for food rising to meet the ever growing world population, food safety is becoming, even more, important §  The reason why food safety has such an important role in the manufacturing process is to ensure the products delivered to consumers do not interfere with a person’s health §  Failing to comply to food safety regulations can result in the transmission of foodborne illnesses
  • 6. © Operational Excellence Consulting. All rights reserved. 6 The Food Supply Chain FOOD SUPPLY CHAIN Storage Processing Logistics Farming & Agriculture Retail & Food Service
  • 7. © Operational Excellence Consulting. All rights reserved. 7 More than 200 diseases are spread through food Source: WHO
  • 8. © Operational Excellence Consulting. All rights reserved. 8 Global Toll – Foodborne Diseases §  2 million deaths occur every year from contaminated food or drinking water §  582 million cases of 22 different foodborne enteric diseases and 351,000 associated deaths §  Salmonella Typhi, the most deadly of the enteric diseases agents, was responsible for 52,000 deaths §  The African region recorded the highest disease burden for enteric foodborne disease, followed by South-East Asia §  Over 40% people suffering from enteric diseases caused by contaminated food were children aged under 5 years Source: World Health Organization (WHO), April 2015
  • 9. © Operational Excellence Consulting. All rights reserved. 9 What is ISO 22000? §  ISO 22000 is a global standard for Food Safety Management Systems (FSMS) §  Designed to enable organizations to control food safety hazards along the food chain §  Applies to all types and sizes of organizations participating in the food chain
  • 10. © Operational Excellence Consulting. All rights reserved. 10 Key Changes to ISO 22000:2018 High Level Structure The new version of ISO 22000 will follow the same structure as all the other ISO management system standards. Risk-based Approach The new standard will now include a different approach to understanding risk. Plan-Do-Check-Act (PDCA) Cycle The standard clarifies the PDCA cycle, by having two separate cycles in the standard working together: one covering the management system and the other, covering the principles of HACCP. The Operation Process A clear description is given of the differences between key terms such as: Critical Control Points (CCPs), Operational Prerequisite Programs (OPRPs) and Prerequisite Programs (PRPs).
  • 11. © Operational Excellence Consulting. All rights reserved. 11 Benefits to an Organization for Implementing a Food Safety Management System §  Preventive approach to food safety §  Conformance to legal and regulatory requirements §  Increase credibility and reputation §  Improves customer satisfaction §  Increase in profitability of the company
  • 12. © Operational Excellence Consulting. All rights reserved. 12 Advantages of Certification §  Compliance with customer requirements specifying certification §  Independent check of conformity §  Indicates an effective Food Safety Management System §  Worldwide recognition §  Provides competitive advantage §  Improves company image
  • 13. © Operational Excellence Consulting. All rights reserved. 13 Overview of Annex SL §  Although Annex SL is a framework for a generic management system, it requires the addition of discipline-specific requirements to make a fully functional standard. Annex SL High-level structure Identical core text Common definition
  • 14. © Operational Excellence Consulting. All rights reserved. 14 The ISO 22000:2018 Structure is Aligned to the Common Structure for MSS 1.  Scope 2.  Normative References 3.  Terms & Definitions 4.  Context of the Organization 5.  Leadership 6.  Planning 7.  Support 8.  Operation 9.  Performance Evaluation 10.  Improvement
  • 15. © Operational Excellence Consulting. All rights reserved. 15 ISO 22000:2018 Approach is Based on the Plan-Do-Check-Act (PDCA) Model C A D P Planning (6) Support (7) & Operation (8) Improvement (10) Performance evaluation (9) Leadership (5) Scope of the food safety management system (4.3/4.4) Intended outcomes of the food safety management system Internal and external issues (4.1) Needs and expectations of workers and other interested parties (4.2) Context of the organization (4)
  • 16. © Operational Excellence Consulting. All rights reserved. 16 The PDCA Cycle at the Two Levels DO (FSMS) 8.  Operation PLAN (FSMS) 4.  Context of the organization 5.  Leadership 6.  Planning 7.  Support (including control of externally provided processes, products or services) CHECK (FSMS) 9.  Performance evaluation ACT (FSMS) 10.  Improvement Organizational planning and control ACT (food safety) Updating of preliminary information and documents specifying the PRPs and the hazard control plan PLAN (food safety) PRPs Traceability System Emergency preparedness & response Hazard analysis Validation of control measures Validation planning Hazard control plan (HACCP/OPRP plan) Operational planning and control CHECK (food safety) Verification activities Analysis of results of verification activities DO (food safety) Implementation of the PLAN (food safety) Control of monitoring and measuring Control of product and process nonconformities
  • 17. © Operational Excellence Consulting. All rights reserved. 17 ISO 22000:2018 Clause Structure (4-10) PLAN DO CHECK ACT 4. Context of the organization 5. Leadership 6. Planning 7. Support 8. Operation 9. Performance evaluation 10. Improvement 4.1 Understanding the organization and its context 5.1 Leadership and commitment 6.1 Actions to address risks and opportunities 7.1 Resources 8.1 Operational planning and control 9.1 Monitoring, measurement, analysis and evaluation 10.1 Nonconformity and corrective action 4.2 Understanding the needs and expectations of interested parties 5.2 Policy 6.2 Objectives of the FSMS and planning to achieve them 7.2 Competence 8.2 Prerequisite programmes (PRPs) 9.2 Internal audit 10.2 Continual improvement 4.3 Determining the scope of the FSMS 5.3 Organizational roles, responsibilities and authorities 6.3 Planning of changes 7.3 Awareness 8.3 Traceability system 9.3 Management review 10.3 Update of the FSMS 4.4 FSMS 7.4 Communication 8.4 Emergency preparedness and response 7.5 Documented information 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
  • 18. © Operational Excellence Consulting. All rights reserved. 18 2021 Full conformance with the new standard Recertification audits to new standard 2018- 2021 2018 Transition to full compliance Published ISO 22000:2018 ISO 22000:2018 Certification Transition Timeline Recertification audits to new standard 2019 Companies that are currently certified to ISO 22000:2005 have to transition to the 2018 version within 3 years of the publication of the new standard 2020
  • 19. © Operational Excellence Consulting. All rights reserved. 19 ISO 22000:2018 Certification Process Request for Registration Document Review Pre-assessment The Registration Audit Take Corrective Action Registration Decision Certification & Publicizing Your Registration Maintaining Registration & Surveillance Audits
  • 20. © Operational Excellence Consulting. All rights reserved. 20 Audit Findings Minor Non-conformity Observation Major Non-conformity
  • 21. © Operational Excellence Consulting. All rights reserved. 21 Auditee’s Conduct §  Polite §  Professional §  Positive / Receptive §  Sincere §  Commitment §  Formal but not overly serious
  • 22. © Operational Excellence Consulting. All rights reserved. 22 Interacting with Auditors §  Be honest and open §  Recognize they may be experts §  Realize they may not be subject matter experts §  Understand the purpose of the meeting and review related records prior to interviews §  Turn mobile phones to silent mode
  • 23. © Operational Excellence Consulting. All rights reserved. 23 Interacting with Auditors §  Assume auditors are familiar with your organization’s FSMS §  Challenge auditors §  Show more competence in ISO 22000 §  Argue internally §  Express unfairness §  Ask for solution §  Fix non-conformities on the spot
  • 24. © Operational Excellence Consulting. All rights reserved. 24 “From Farm to Plate, Make Food Safe.”
  • 25. © Operational Excellence Consulting. All rights reserved. About Operational Excellence Consulting
  • 26. © Operational Excellence Consulting. All rights reserved. 26 About Operational Excellence Consulting §  Operational Excellence Consulting is a management training and consulting firm that assists organizations in improving business performance and effectiveness. §  The firm’s mission is to create business value for organizations through innovative operational excellence management training and consulting solutions. §  OEC takes a unique “beyond the tools” approach to enable clients develop internal capabilities and cultural transformation to achieve sustainable world-class excellence and competitive advantage. For more information, please visit www.oeconsulting.com.sg
  • 27. © Operational Excellence Consulting. All rights reserved. END OF PARTIAL PREVIEW To download this presentation, please visit: www.oeconsulting.com.sg