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ISO 22000:2018 (Food Safety Management Systems) Awareness Training

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ISO 22000:2018 (Food Safety Management Systems) Awareness Training

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  1. ISO 22000:2018 Food Safety Management Systems © Operational Excellence Consulting © Operational Excellence Consulting. All rights reserved.

  2. NOTE: This is a PARTIAL PREVIEW. To download the complete presentation, please visit: https://www.oeconsulting.com.sg LEARNING OBJECTIVES Describe the audit approach and learn useful tips for handling an audit session Provide background knowledge on ISO 22000 Gain an overview of the ISO 22000:2018 structure Define the ISO 22000:2018 certification process 2 © Operational Excellence Consulting

  3. CONTENTS 02 03 04 05 01 OVERVIEW OF ISO 22000 ISO 22000:2018 STRUCTURE ISO 22000:2018 CERTIFICATION PROCESS HANDLING AN AUDIT SESSION AUDIT APPROACH 3 © Operational Excellence Consulting

  4. ISO STANDARDS CONTRIBUTE DIRECTLY TO THE U.N. SUSTAINABLE DEVELOPMENT GOALS (SDGs) Some examples of popular ISO standards that are adopted by various companies and organizations: ISO 9001:2015 ISO 14001:2015 ISO 45001:2018 ISO 26000:2010 Quality Management Systems Environmental Management Systems Occupational Health & Safety Management Systems Social Responsibility ISO/IEC 27001:2022 ISO 37001:2016 ISO 50001:2018 ISO 22000:2018 Anti-Bribery Management Systems Energy Management Systems Food Safety Management Systems Information Security Management Systems 4 © Operational Excellence Consulting

  5. 600 M Or almost 1 in 10 people around the world fall ill after eating contaminated food, leading to over 420,000 deaths every year. 5 Source: World Health Organization (WHO), 2022 © Operational Excellence Consulting

  6. MORE THAN 200 DISEASES ARE SPREAD THROUGH FOOD Unsafe food can have severe health consequences, so it's crucial for organizations in the food supply chain to take steps to ensure their processes and products are safe. 6 © Operational Excellence Consulting

  7. WHAT IS ISO 22000? ISO 22000 is a food safety standard for businesses in the global food chain ● Specifies requirements for a Food Safety Management System (FSMS) ● Combines and supplements the core elements of ISO 9001 and HACCP to provide an effective framework for food safety management ● Covers organizations across the whole food chain, from the farm to the table © Operational Excellence Consulting ● 7 © Operational Excellence Consulting

  8. KEY FEATURES OF ISO 22000:2018 Enables a common understanding of what a food safety management system is Harmonizes the voluntary international standards Employs proven management system principles Global food safety standard Requires legal compliance checking Internal and external monitoring Integrates existing good practice 8 © Operational Excellence Consulting

  9. PRIMARY ELEMENTS OF AN FSMS Interactive System management that includes documentation Prerequisite programs, which ensure a clean, sanitary environment HACCP principles, which help identify, prevent and remove food safety hazards communication across the organization 9 © Operational Excellence Consulting

  10. BENEFITS TO AN ORGANIZATION FOR IMPLEMENTING AN FSMS Improves health and safety Conformance to legal and regulatory requirements Improves transparency Increase credibility and reputation Improves customer satisfaction Increase in profitability of the company 10 © Operational Excellence Consulting

  11. ADVANTAGES OF CERTIFICATION Certification to ISO 22000 is voluntary ● Independent check of conformity by a third party ● Indicates an effective FSMS ● National/International recognition ● Provides competitive advantage ● Improves company image ● © Operational Excellence Consulting © Operational Excellence Consulting 11 11

  12. RISK-BASED THINKING Scope, Context, Criteria Identifying potential risks, likelihood and consequences ● Risk Assessment MONITORING & REVIEW COMMUNICATION & CONSULTATION Risk Documenting assumptions and criteria ● Identification Risk Analysis Identifying activities by risk classification in order of priority ● Risk Evaluation Allocating necessary resources to risk management plan ● Risk Treatment RECORDING & REPORTING Documenting results and develop a Risk Management Action plan ● 12 © Operational Excellence Consulting

  13. ANNEX L IS A FRAMEWORK FOR A GENERIC MANAGEMENT SYSTEM Annex L High-level structure Identical core text Common definition However, it requires the addition of discipline-specific requirements to make a fully functional standard. 13 © Operational Excellence Consulting

  14. ISO 22000:2018 IS BASED ON THE ISO HIGH-LEVEL STRUCTURE FOR MANAGEMENT SYSTEM STANDARDS 1. Scope 6. Planning 2. Normative References 7. Support 3. Terms & Definitions 8. Operation 4. Context of the Organization 9. Performance Evaluation 5. Leadership 10. Improvement 14 © Operational Excellence Consulting

  15. HLS –THE SAME CORE ELEMENTS Environment ISO 14001 Quality Management ISO 9001 THE SAME CORE ELEMENTS Occupational Health & Safety ISO 45001 Food Safety ISO 22000 15 © Operational Excellence Consulting

  16. ISO 22000:2018 IS BASED ON THE PDCA MODEL SCOPE OF THE FOOD SAFETY MANAGEMENT SYSTEM (4.3/4.4) ESTABLISH FSMS INTERNAL & EXTERNAL ISSUES (4.1) Do Plan INTENDED OUTCOMES OF THE FOOD SAFETY MANAGEMENT SYSTEM MAINTAIN & IMPROVE THE FSMS IMPLEMENT & OPERATE THE FSMS NEEDS & EXPECTATIONS OF INTERESTED PARTIES (4.2) Check Act MONITOR & REVIEW THE FSMS 16 Source: Adapted from ISO © Operational Excellence Consulting

  17. ISO 22000 –THE PDCA CYCLE AT THE TWO LEVELS Organizational planning and control CHECK (FSMS) PLAN (FSMS) Context of the organization Leadership Planning Support (including control of externally provided processes, products or services) DO (FSMS) ACT (FSMS) 4. 8. Operation 9. Performance evaluation 10. Improvement 5. 6. 7. Operational planning and control PRPs Validation of control measures Hazard control plan (HACCP/OPRP plan) Validation planning Hazard analysis Traceability System Emergency preparedness & response PLAN (food safety) Implementation of the PLAN (food safety) Verification activities Updating of preliminary information and documents specifying the PRPs and the hazard control plan Control of monitoring and measuring Analysis of results of verification activities Control of product and process nonconformities CHECK (food safety) ACT (food safety) DO (food safety) 17 Source: Adapted from ISO © Operational Excellence Consulting

  18. ISO 22000:2018KEY 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

  19. CONTINUOUS IMPROVEMENT OF THE FSMS Monitoring, Corrective Action Verification Improvement Implementation Establishing a HACCP Plan Planning, Realization of Safe Product(s) Preliminary Steps to Enable Hazard Analysis Validation of Control Measures Hazard Analysis Establishing Operational PRPs 19 Source: ISO 22004 © Operational Excellence Consulting

  20. BECOMING ISO 22000:2018 CERTIFIED The certification body examines the FSMS for conformity to the ISO 22000:2018 standard ● The FSMS audit is a compliance audit ● Certification means the organization has a documented FSMS that is fully implemented and meets ISO 22000:2018 requirements ● 20 20 © Operational Excellence Consulting © Operational Excellence Consulting

  21. ISO 22000:2018 CERTIFICATION PROCESS Conduct Internal Audit and Review Result by Top Management Confirmation of Registration Stage 1 Audit 2 4 6 1 3 5 7 Implementation of FSMS Selection of a Certification Body Stage 2 Audit Continual Improvement and Surveillance Audits 21 © Operational Excellence Consulting

  22. WHAT DOES CERTIFICATION ASSURE? Regular assessment to continually monitor and improve processes Credibility that the system can achieve its intended outcomes Consistency in the outputs designed to meet stakeholder expectations Reduced risk and uncertainty and increase market opportunities 22 © Operational Excellence Consulting

  23. WHAT IS AN ISO AUDIT? An ISO audit is an audit of your organization’s compliance with one of the standards set forth by the International Organization for Standardization (ISO). An audit measures your company’s systems against any ISO standard (e.g. ISO 22000:2018). 23 © Operational Excellence Consulting

  24. INTERNAL AUDIT To ensure the whole FSMS management system is audited to check: ● The system is being followed o The system meets ISO 22000:2018 requirements o The system is effectively implemented and maintained o 24 24 © Operational Excellence Consulting © Operational Excellence Consulting

  25. AUDIT FINDINGS MAJOR NONCONFORMITY MINOR NONCONFORMITY OBSERVATION § A minor nonconformity is an observed lapse in your systems ability to meet the requirements of the standard or your internal systems, while the overall process remains intact § An observation or opportunity for improvement relates to a matter about which the Auditor is concerned but which cannot be clearly stated as a non- conformity § A major nonconformity relates to the absence or total breakdown of a required process or a number of minor nonconformities listed against similar areas § A major nonconformity at the Registration Audit would defer recommendation for registration until that major has been closed § Observations also indicate trends which may result in a future nonconformity 25 © Operational Excellence Consulting

  26. HOW TO HANDLE AN AUDIT SESSION? Do not panic Offer evidence and explain patiently Take note of improvement areas highlighted by the auditor Ask and clarify Show internal audit report, when necessary Admit obvious non-conformities 26 © Operational Excellence Consulting

  27. AUDITEE’S CONDUCT Polite ● Professional ● Positive / Receptive ● Sincere ● Commitment ● Formal but not overly serious ● © Operational Excellence Consulting © Operational Excellence Consulting 27 27

  28. INTERACTING WITH AUDITORS –DO’S Be honest and open Turn mobile phones to silent mode ● ● Recognize they may be experts Get the right person in to answer the question ● ● Realize they may not be subject matter experts ● Listen carefully and understand each question before answering – Be sure responses are complete and accurate ● Understand the purpose of the meeting and review related records prior to interviews ● 28 © Operational Excellence Consulting

  29. “From Farm to Plate, Make Food Safe.” © Operational Excellence Consulting

  30. ABOUT OPERATIONAL EXCELLENCE CONSULTING Operational Excellence Consulting is a management training and consulting firm that assists organizations in improving business performance and effectiveness. Based in Singapore, the firm’s mission is to create business value for organizations through innovative design and operational excellence management training and consulting solutions. For more information, please visit www.oeconsulting.com.sg © Operational Excellence Consulting

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