ISO Food Safety Management System Implementation Workbook

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This FSSC 22000 Implementation Workbook compliments our comprehensive FSSC 22000 Packaging Food Safety Management System package and guides you on the path to achieving FSSC 22000 Certification. We have written this workbook to assist in the implementation of your food safety management system. The workbook is divided into 9 steps that are designed to assist you in implementing your food safety management system effectively: Step One: ISO 22000 & PAS 223 Familiarisation Step Two: GAP Analysis Step Three: Senior Management Implementation Step Four: Project 22000 Step Five: Food Safety Quality Management System Step Six: HACCP Implementation Step Seven: Internal Auditing Training & Checklists Step Eight: Review and Updating Step Nine: Final Steps to FSSC 22000 Certification 1

Training: Understanding ISO 22000 The one hour Understanding ISO 22000 interactive PowerPoint training guide supplied can be used to aid your staff in understanding the ISO 22000:2005 standard. It includes: The key elements to ensuring food safety An explanation of prerequisite programmes The principles of HACCP ISO 22000 definitions The documents required to meet the standard And much more... 3

Training: ISO 22000 Document Requirement Guide The ISO 22000 Document Requirement Guide PowerPoint presentation supplied explains to the Food Safety Team the documentation required in an ISO 22000 compliant Food Safety Management System. 4

Step Two: Gap Analysis At this stage an assessment should be made by the most senior technical member of the management team to decide what requirements of PAS 223:2011 (Prerequisite programmes and design requirements for food safety in the manufacture and provision of food packaging) and ISO 22000:2005 (Food safety management systems - Requirements for any organization in the food chain) the facility meets and also identify areas which are not compliant. The nominated manager should read through the requirements in PAS 223:2011 and ISO 22000:2005 and assess for compliance using the checklist to record their findings. PAS 223:2011 CONFORMANCE ANALYSIS 4. Construction and Layout of Buildings PAS 223 Requirements 4.1 General requirements 4.2 Environment 4.3 Locations of establishments Compliant Yes No Comments 5. Layout of Premises Workspace PAS 223 Requirements 5.1 General requirements 5.2 Internal design, layout and traffic patterns 5.3 Internal structures and fittings 5.4 Equipment 5.5 Temporary/mobile structures 5.6 Storage PAS 223 Requirements Compliant Yes No 6. Utilities Compliant Yes No Comments Comments 6

ISO 222000 Food Safety Management System Requirements Internal Audit ISO 22000 Section Audit Findings 4.1 General Requirements Has an effective food safety management system been documented and implemented? Is the FSMS maintained and updated? Has the scope of the food safety management system been defined including the products or product categories, processes and production sites? Does the FSQMS ensure that food safety hazards are identified, evaluated and controlled? Is there communication of appropriate information throughout the food chain regarding safety issues? Is there communication of information regarding development, implementation and updating of the food safety management system throughout the organization? Does the FSQMS incorporate the most recent information on the food safety hazards subject to control? Is control of outsourced processes identified and documented within the food safety management system. 4.2 Documentation Requirements Is there a documented food safety policy and objectives? Is there sufficient documentation to ensure the effective development, implementation and updating of the food safety management system. Are food safety management system documents controlled? 4.2.2 Control of Documents 11

Ensure any areas requiring action are identified Areas requiring improvement identified in the assessment of compliance with PAS 223 & ISO 22000 should be logged. Date PAS 223 or ISO 22000 Clause Details of Non Compliance Corrective Action Required Responsibility Target completion Date Date Completed 40

Step Three: Senior Management Implementation An 11 step Senior Management Implementation checklist is provided that establishes your Food Safety Management System fundamentals including Food Safety Policies and Objectives. The checklist guides Senior Management: in planning the establishment of the FSMS in providing adequate support to establish the FSMS in ensuring there is adequate infrastructure and work environment in allocating responsibility and authority This stage requires the Senior Management to meet and establish the foundations for the Food Safety Management System: Formulating a checklist of Customer, Regulatory, Statutory and other relevant Food Safety requirements Decide which Food Safety requirements the company should address and develop relevant policies. Based on the Food Safety Policy Management Policies establish Food Safety Objectives Define the scope and boundaries of the FSMS Plan the establishment of the FSMS using the project planner Provide adequate support to establish the FSMS Ensure there is adequate infrastructure and work environment Allocate responsibility and authority Assess, plan and establish appropriate internal and external communication (including the food chain) channels A meeting should now be co-ordinated involving all the Senior Management Team. 41

Senior Management FSMS Implementation Meeting Date Time Venue Agenda 1. Formulating a checklist of Customer, Regulatory, Statutory and other relevant Food Safety requirements 2. Decide which Food Safety requirements the company should address and develop relevant policies. 3. Based on the Food Safety Policy Management Policies establish Food Safety Objectives 4. Define the scope and boundaries of the FSMS 5. Plan the establishment of the FSMS using the project planner 6. Provide adequate support to establish the FSMS 7. Ensure there is adequate infrastructure and work environment 8. Allocate responsibility and authority 9. Assess, plan and establish appropriate internal and external communication (including the food chain) channels Attendees: Senior Management Team Job Title Name Role in Team Managing Director Site Director Operations Manager Technical Manager Planning Manager Distribution Manager Maintenance Manager Finance Manager Human Resources Manager Chairman Deputy Chair Operations Reporting Food Safety and Quality Reporting Management Representative Planning and Capacity Reporting Distribution Reporting Services and Engineering Provision Financial Reporting Resource reporting 42

Senior Management FSMS Implementation Checklist The Senior Management FSMS Implementation Meeting should follow the guidelines of the Senior Management Implementation Checklist: Senior management formulate a checklist of Customer, Regulatory, Statutory and other relevant Food Safety requirements Customer/Regulatory/Statutory/Other Record Details Action (i) Senior Management decides which Food Safety requirements the company should address and develop relevant policies. Requirement Policy Details Action (ii) 43

Senior Management Establish the Project Plan Using the Excel Project Planner Senior Management adapt the template supplied with the system to establish a Project Plan. 51

- Ensuring that the Food Safety team are fully qualified and trained to meet the company requirements. - Promotion of the awareness of customer requirements throughout the company. - External communication and liaison regarding the management systems. Site and Departmental Annual Objectives and targets are agreed and documented in the Management Review minutes. Key Personnel and Nominated Deputies Job Title Job Holder Nominated Deputy Emergency Response Coordinator Food Safety Team Leader Management Representative Site Director Operations Manager Production Manager Warehouse Manager Maintenance Manager Factory Safety Manager Human Resource Manager Quality Manager Production Supervisor Packing Manager Technical Manager Planning Manager Goods Receipt Manager Design and Development Manager Planning Manager Customer Service Manager Laboratory Manager Distribution Manager Project Manager 55

The Food Safety Team Training Introduction to ISO 22000 Presentation Understanding ISO 22000 Training: ISO 22000 Document Requirement Guide Prerequisite Training The Prerequisite Programme PowerPoint presentation supplied explains the part that prerequisites play in an ISO 22000 compliant Food Safety Management System. Training: Food Safety Team: ISO 22000 Implementation Guide The Food Safety Team: ISO 22000 Implementation Guide PowerPoint presentation supplied with the system explains to the Food Safety Team exactly how to implement an ISO 22000 compliant Food Safety Management System. 68

Project Planning Tasks Responsibility Comments 1) Senior management demonstrate a commitment to food safety 2) Senior management issue a food safety policy 3) Senior management establish food safety objectives 4) Senior management define the scope and boundaries of the FSMS. 5) Senior management plan the establishment of the FSMS. 6) Senior management provide adequate support to establish the FSMS. 7) Senior management ensure there is adequate infrastructure and work environment. 8) Senior management appoint a food safety team leader 9) Senior management appoint the food safety team. 10) FSMS responsibilities and authorities are documented and communicated 11) Food safety communication systems are put in place Senior Management Team Senior Management Team Senior Management Team Senior Management Team Senior Management Team Senior Management Team Senior Management Team Senior Management Team Senior Management Team Senior Management Team Senior Management Team Due Date for Completion Date Completed Completed in Step 3 10/8/13 9/8/13 Completed in Step 3 10/8/13 9/8/13 Completed in Step 3 10/8/13 9/8/13 Completed in Step 3 10/8/13 9/8/13 Completed in Step 3 10/8/13 9/8/13 Completed in Step 3 10/8/13 9/8/13 Completed in Step 3 10/8/13 9/8/13 Completed in Step 3 10/8/13 9/8/13 Completed in Step 3 10/8/13 9/8/13 Completed in Step 3 10/8/13 9/8/13 Completed in Step 3 10/8/13 9/8/13 74

Step Five: Food Safety Quality Management System The Food Safety Management System templates provided with the package contain comprehensive FSSC 22000 documentation including: Food Safety Quality Manual containing a set comprehensive procedures and record templates. HACCP manual containing food safety procedures and our unique ISO HACCP Calculator. Laboratory manual including sample procedures and records. Prerequisite Programmes Manual. Operational Prerequisite Programmes Templates. At this stage you can choose to totally implement the procedures supplied or pick those that are applicable to your process. Food Safety Quality Manual The Food Safety Quality Manual contains comprehensive top level procedures templates that form the foundations of your Food Safety Management System so you don't have to spend 1,000's of hours writing compliant procedures: FSSC 22000 Food Safety Management System Section 4.1 Introduction to the Food Safety Management System Communication Overview The Food Safety Management System Senior Management Responsibility Document Hierarchy Food Safety System Process Diagram Documentation Requirements Section 4.2 Document Control Procedure Record Control Procedure Management Responsibility Section 5.1 Section 5.2 Senior Management Commitment Food Safety and Quality Policy 81

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Operational Prerequisite Programmes Manual A set of operational prerequisite programmes including matching validation records and verification records: OPRP 1 Glass & Brittle Material Breakage Procedure OPRP 2 Metal Detection OPRP 3 Control of Knives OPRP 4 Maintenance OPRP 5 Hygiene Policy OPRP 6 Glass Policy OPRP 7 Control of Brittle Materials OPRP8 Control of Purchased Materials and Service 94

Significance Severity Probability ISO 22000 Food Safety Management System Implementation Workbook Then the Food Safety Team assess the severity of the hazard and enters: - 1 for Not Severe - 2 for Could possibly cause illness - 3 for Severe (Could be fatal) The Food Safety team should factor in the vulnerability of the targeted consumer, the survival and multiplication of any biological hazards and any likely toxin production, the presence of chemicals or foreign bodies, contamination at any stage in the process and possible deliberate contamination or adulteration to the severity score to determine all the Significant Food Safety Hazards which score a 9 as highlighted in red on the HACCP calculator. Step Number Step Name Hazards Identified 1 Delivery of Material A Heavy Metal Contamination 1 3 3 1 Delivery of Material A Campylobacter spp. 2 3 6 1 Delivery of Material A Contamination with Bacteria from pests 3 3 9 1 Delivery of Material A Pesticides 3 1 3 1 Delivery of Material A Salmonella spp. (S. typhimurium, S. enteriditis) 3 3 9 1 Delivery of Material A Bacteria (spore-forming) General 2 2 4 All of the food safety hazards that score a 9 on the HACCP calculator are regarded as significant and form the Significant Food Safety Hazard List. 107

Follow the HACCP Calculator Instructions: 110

Step Seven: Internal Audits Included in the package is an ISO 22000 Internal Auditor Training Presentation plus a set of ISO 22000 internal auditing checklists that can be used to train your Internal Auditors. The audit checklists cover the sections of the ISO 22000 standard including management responsibility, planning and realization of safe products, resources management, validation, verification and improvement. 130

Internal Auditing Training & Checklists 131

Step Eight: Review and Updating Task 47 The senior management team carry out food safety management reviews Senior management should review the company management systems, at a minimum, annually to ensure their continuing suitability, adequacy and effectiveness. The review should includes assessing opportunity for improvements and the need for amendments to the systems. The proceedings of all reviews are to be documented. The review meeting is normally chaired by the most Senior Manager and includes Senior Management from Technical, Operations, Engineering, Planning, Distribution and quality departments. Review should inputs include: - Review of the Quality and Food Safety Policy - Review of Management Changes - Minutes and Follow-up actions from previous review meetings - Outstanding Non-conformances as a result of internal and external audits - Results of external second and third-party audits - Trend analysis of Customer and Supplier complaints - Analysis of the results of verification activities including internal hygiene and HACCP plan verification audits - Quality Key Performance Indicators Review and trend analysis - Emergencies and Accidents - Process performance and product conformity - Corrective and preventive action status - Food Safety incidents including allergen control and labelling, recalls, withdrawals, safety or legal issues - Review of planning and development of the processes needed for the realisation of safe products including changes which could affect food safety and the HACCP Plan (including legislation changes and scientific information) - Changes to policies and objectives - Communication activities and effectiveness of communication - Results of review and system updating - Review of Resources and effectiveness of Training - Recommended improvements 135

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Stage 8 Final Steps to ISO 22000 Certification There a few final steps to achieving ISO 22000 Certification: Carry out an assessment of your system to make sure that it meets the requirements of the ISO 22000 standard using our ISO 22000 Checklists Ensure any areas requiring corrective action are addressed Choose your Certification Body Make contact with the Certification Body Pre-assessment Formal assessment Certification Celebrate! Communicate your success! Carry out an assessment of your system to make sure that it meets the requirements of the ISO 22000 standard using our ISO 22000 Checklists: Using our comprehensive ISO 22000 Requirements Checklists assess your food safety management system to ensure that you are satisfied that it meets the requirements of the standard: 143

Ensure any areas requiring corrective action are addressed The non-compliances identified in the assessment of compliance with ISO 22000 should be logged by the Food Safety Team Leader and the appropriate corrective action allocated and taken: Date ISO 22000 Clause Details of Non Conformance Identified by: Corrective Action Required Responsibility Target completion Date Date Completed 178