GUIDELINES FOR COACHING ON FOOD SAFETY CONTENTS (i). Introduction 3 1. Prerequisite Programs 1.1. The Construction and Layout of Buildings 6 1.2. The Layout of Premises and the Workspace 7 1.3. Utilities: Air, Water, Energy 8 1.4. Waste Management 9 1.5. Equipment Suitability, Cleaning, and Maintenance 10 1.6. Management of Purchased Materials 11 1.7. Measures for the Prevention of Cross-Contamination 12 1.8. Cleaning and Sanitizing 13 1.9. Pest Control 14 1.10. Personal Hygiene and Employee Facilities 15 1.11. Rework 16 1.12. Product Withdrawal and Recall 17 1.13. Warehousing 18 1.14. Product Information and Consumer Awareness 19 1.15. Food Defence, Bio-vigilance, and Bioterrorism 20 1.16. Food Fraud 21 2. Food Safety Management System 2.1. Context of the Organization 23 2.2. Needs and Expectations of Interested Parties 24 2.3. Scope of the Food Safety Management System 25 2.4. Food Safety Management System 26 2.5. Food Safety Policy 27 2.6. Organizational Role, Responsibility, and Authority 28 2.7. Risks and Opportunities 29 2.8. Food Safety Objectives 30 2.9. Change Management 31 2.10. Competence 32 2.11. Infrastructure 33 2.12. Work Environment 34 2.13. Communication 35 2.14. Documented Information 36 2.15. Traceability 37 2.16. Emergency Preparedness and Response 38 2.17. Control of Monitoring and Measurement 39 2.18. Nonconformity and Corrective Actions 40 2.19. Withdrawal and Recall 41 2.20. Performance Evaluation 42 2.21. Internal Audit 43 2.22. Management Review Meeting 44 3. Hazard Analysis Critical Control Points 3.1. Development of the HACCP Plan 46 3.2. HACCP System Requirements 47 Annex 1: Tips for Virtual Training and Coaching 49 Annex 2: Scheduling and Project Tracking 51 2 INTRODUCTION This document provides guidelines for food safety In general, there are three phases in coaching a client food specialists and consultants on coaching client food safety team, as follows: (1) use the initial assessment as safety teams. The main objective of the document a guide and analyze the current situation and condition is to ensure a consistent approach across all food underlying each element of the prerequisite program safety projects. The guidelines are not intended to (PRP) or FSMS, (2) adopt a step-by-step approach to the replace engagement with experienced specialists or implementation of specific elements of the PRP or FSMS consultants during the project. and to additional requirements, and (3) maintain and update the FSMS that has been implemented by the food Assess, train, coach, and reassess is the approach of the safety team. These three phases are explained under each International Finance Corporation (IFC) in providing food topic by relying on a color-coded format, as follows: safety advisory services. To ensure that all specialists and consultants have the same understanding, each activity is clearly defined. Brief explanations are as follows: • Assessment involves the use of a set of criteria or a food safety standard, making a judgment on which of the requirements are fulfilled and which are not yet fulfilled. An initial food safety assessment report usually covers any gaps identified in the effort to meet the food safety standard and a relevant implementation plan. • Training involves an established curriculum that is delivered on a one-to-many basis. The focus is on building skills or individual behavioral change. • Coaching involves a personalized plan that has been devised by the coach and the protégée and that is delivered on a one-to-one or one- to-few basis. While the focus may be on building skills, it is more often viewed as an opportunity for strategizing or for the coach to serve as a thinking partner. Because the competency and capability of each client food safety team and the complexity of each process vary, no single solution should be considered better for coaching every team. This document is best used as a compass while walking the client through the journey during implementation. It is not necessary to follow every step mentioned under every heading. The topics in this document have been selected to conform to the Global Food Safety Initiative’s (GFSI) Global Markets Program (GMaP), the International Organization for Standardization (ISO) 22000 food safety management standard, and the ISO 22002-1 technical specification (TS). It is thus the consultant’s responsibility to understand the client’s needs, make necessary adjustments during implementation by, for example, providing coaching on additional requirements, achieve the targeted certification, and meet applicable local norms, exporting country regulations, and • The title of each page may refer to a PRP, an element the requirements of customers. of the FSMS, or a key item in the hazard analysis critical control point (HACCP). The food safety specialists and consultants should coach • The bar above describes the phases: assessment the client’s food safety team according to these guidelines, and implementation, system requirements, and explain the reasons behind each procedure, and clarify all maintenance and update. The phases are also color- documented information. A good understanding of the coded. why will help the team not only establish a viable food • A description in bold or a step in dark blue are the safety management system (FSMS), but also maintain intermediate level requirements of the GMaP; the and update the system as required. Every IFC Food Safety reader may also refer to the clause number. Advisory Project begins with an initial assessment and • The numbers in the right columns refer to the an implementation plan, which may then be followed clauses of the GMaP or the ISO 22000 and ISO/TS by a project tracker. A template for tracking the progress 22002-1 requirements. of a project and for checking if all items are addressed is • Food fraud is also covered. It has become provided in annex 1. These guidelines can be used in face- more important to protect food products from to-face or virtual coaching. There are some differences contamination or adulteration that is aimed at between in-person and virtual deliveries. Appropriate tips causing public health problems or business losses. on virtual training and coaching are provided in annex 2 to assist the consultant in delivering the services effectively. 3 INTRODUCTION GENERAL GUIDELINES FOR COACHING CLIENT FOOD SAFETY TEAMS In this phase, the consultant Baseline study or gap assessment - walk the factory, collect data, gets to know the details of the Assessment & Implementation interview management and employees, and so on. specific food business more clearly by walking the factory and having conversations with Define specifications, criteria, roles, and responsibilities, and so on. management and employees. Conduct risk assessments as needed. The consultant’s role is to identify gaps between the current conditions and the Develop and document procedures, programs, plans, policies, requirements of the standard. schedules, standard operating procedures (SOPs), and forms The output of earlier steps feeds into the next steps. Implement procedures, programs, and plans and record activities and results The requirements of the GMaP and ISO22000 Description GMaP ISO or ISO/TS 22002-1: The clauses can be seen in the columns or separately in the color-coded format. The Implementation requirements Ref clause Ref clause consultant needs to ensure that the client’s FSMS meets the targeted food safety certification requirements, local and export country regulations, and customer Requirements Record requirement needs. Documented record requirements are shown in italics. GMaP System requirements Clause ... no. ISO 22000 Clause 4.1 no. This shows what the food Training of respective department (or) all staff safety team needs to do to sustain the FSMS implemented at their site. Client involvement Monitoring, recording, and evaluation Maintain & Update beginning at the assessment phase is key to sustaining the system after the Monthly trends and corrective action and preventive actions consultant has completed (CAPA), if needed the implementation and departed from the client’s team. Report trends and significant changes at the management review meeting (MRM) Periodic review of the PRP 4 PREREQUISITE PROGRAMS INTRODUCTION 1.1. THE CONSTRUCTION AND LAYOUT OF BUILDINGS Assess the current situation: the external environment, fences, entrances, roof, building design Assessment & Implementation and layout, employee facilities, external lighting, drainage, wastewater system, surroundings of buildings, external cleaning and maintenance, waste collection areas Develop – (1) improvement plan (if needed) and (2) external cleaning and maintenance program Follow up on progress; Implement the external cleaning and maintenance program Description GMaP ISO • No source of contamination next to the factory B.B.2 4.1 • Complete fence 4.2 • Clearly defined gates with control of access (for example, a guardhouse) 4.3 • Solid buildings that are properly designed 4.3 • No trees or soil next to building 6.6 • No construction sites in the compound unless properly isolated or barricaded • Sufficient lighting in the compound • Light fixtures to be protected (related PRP Control of Cross-contamination–GMaP: B.B.4 Requirements and ISO:10.4) • Food-contact structures: surfaces and materials that come into contact with food are easy to maintain, clean, and, where appropriate, disinfect • Properly sloped and well-maintained drains • Free of waste and debris in the compound (related PRP Waste Management–GMaP: B.B.8 and ISO:7.1-7.4) • Changing rooms provided for staff B.B.7 • Sufficient number of toilets provided, operational, accessible, and adequatelysegregated from processing and food handling areas • Suitable and sufficient hand-washing facilities provided and accessible • Lunch room facilities provided away from production, packaging, and storageareas • Review of contamination prevention procedures conducted at least annually Records required 4.2 - Access control records (vehicles, employees, contractors, visitors) - Site cleaning and maintenance records - Contamination prevention program review record Training of respective department (or) all staff Maintain & Update Regular monitoring, cleaning and maintenance, and inspection Report incidents (if any) at the MRM Periodic review of the facility environment 6 INTRODUCTION 1.2. THE LAYOUT OF PREMISES AND THE WORKSPACE Check the internal environment: walls, floors, ceilings, doors and windows, storage areas, drain Assessment & Implementation points, drains, equipment design and layout; review the locations of high- vs. low-risk zones; review production lines Define risk zones; develop pathways of materials and people; develop an improvement plan (if any changes are required); develop building cleaning & maintenance program; develop environmental monitoring program (sampling, testing, reporting, trending) Follow up on progress; implement building cleaning & maintenance program Description GMaP ISO Related FSMS element 2.11. infrastructure – ISO: 7.1.3. B.B.4. Proper doors, windows, screens, physical barriers (for example, shoe change bench) or effective proce- dures in place Internal layout design is available. 5.1 Good hygiene a n d manufacturing practices are followed. Internal layout and traffic patterns and routes (raw materials, products, waste, personnel) and entry and 5.2 exit points are available. Suitable materials and design in construction, curved wall-floor junctions, dry or drainable floors,ceil- 5.3 ings, screened windows, vents are in place. Doors are closed when not in use. Hygienic design and appropriate location of equipment. 5.4 Requirements Laboratory activities are controlled in designated areas. 5.5 Design and location are assessed; additional assessments are conducted if there are hazards associated 5.6 with temporary or mobile premises and vending machines. Storage areas are identified and marked. 5.7 All items are placed off the floor by using pallets, and sufficient space is maintained for inspections. Chemical and other hazardous substances are stored in designed storage areas only. Bulk storage procedures are established and followed. Records required - Assessment records - Temperature, relative humidity records on storage areas A documented building maintenance program is established I.B.10 An effective building maintenance program is implemented Hygiene and clearance procedures for all maintenance activities are in place Hygiene procedures for maintenance activities are reviewed and their effectiveness has been verified Suitable materials are used for maintenance and repair Maintenance records - Building maintenance program review record - Hygiene control records and area clearance records - Review records on hygiene procedures for maintenance activities Training of all staff Maintain & Update Regular monitoring, cleaning and maintenance, and inspection Report incidents and changes (if any) at the MRM Periodic review of premises and workspaces 7 INTRODUCTION 1.3. UTILITIES: AIR, WATER, ENERGY Check existing air and water supply: from source to point of use; product contact air vs. ventilation Assessment & Implementation vs. compressed air; portable vs. technical water supply vs. return lines; treatment (if any); stagnation; differential pressure; flow disturbance; user point treatment, filtration, cleaning; air and water quality monitoring program; check electricity lines and backup energy system Develop a maintenance program (such as drain water lines, air filter cleaning and replacement); air and water quality monitoring program (sampling, testing, reporting, trending, and review) Implement quality monitoring program and maintenance program Description GMaP ISO Control measures implemented to ensure the quality of water and guarantee that B.B.6.1 6.1 steam and ice do not compromise the safety of food products 6.2 Potable water is physically segregated from non-potable water, and lines are color-coded B.B.6 6.2 orlabelled; water quality requirements are specified and met Ingredient water, cleaning water, product contact air, and room air are monitored 6.1/6.4 through the respective programs; residual chlorine is checked at the point of use 6.2 Water that may come indirectly into contact with products are identified and checked to 6.2 ensure it meets specified quality and micro requirements (Recommendation) potable water pipes should be accessible to disinfection 6.2 Boiler chemicals should include only approved additives, stored separately, and secured 6.3 Requirements Filtration, relative humidity and micro requirements are established; controls are in place 6.4 on air that comes into contact with products Sufficient ventilation should be provided; correct air flows from high- to low-risk zones, systems are cleanable; periodic inspections are carried out of external filters and air intakes Quality monitoring and control and correct pressure differentials in room air are maintained Compressed air and other gases: construction and maintenance to prevent 6.5 contamination;food grade; filtered; use of oil-free compressors or food grade oil Records required Water, steam, and ice test records and results List of approved chemicals Air monitoring test records and results, room temperature and relative humidity records, differential pressure records, filter cleaning and replacement records Certificate of analysis or test results of compressed air and other gases Training of all staff Maintain & Update Regular monitoring, cleaning and maintenance, and inspection Report incidents and changes (if any) at the MRM Periodic review of facility environment 8 INTRODUCTION 1.4. WASTE MANAGEMENT Identify waste generation points and temporary storage locations Assessment & Implementation Define the waste transfer route(s) Develop storage, transfer and disposal methods based on waste types Implement a waste management program Description GMaP ISO Identified waste generation points B.B.8 7.1 Waste bins have lids and are color-coded and labeled 7.2 Waste bins are located in designated areas Waste bins are properly utilized and cleaned 7.3 A waste transfer route has been defined (related PRP: Layout of building Requirements premises and workplace GMaP: B.B.4, ISO: 5.2), and waste is transferred over this route The temporary waste collection bin is at least 10 feet from the building and regularly cleaned Waste disposal by a third party has been organized A procedure for managing ‘waste containing labels and packaging materials’ has been established 7.4 Drains are properly designed (sufficient to handle flow, only to flow from high- to low-hygiene zones, and so on), maintained, and cleaned Waste disposal record Training of all staff Monitoring, recording, and inspection Maintain & Update Monthly record of CAPA (if any) Report at the MRM (if necessary) Periodic review of the waste management system 9 INTRODUCTION 1.5. EQUIPMENT SUITABILITY, CLEANING, AND MAINTENANCE Identify and prepare a list of equipment Assessment & Implementation Ensure the suitability of construction materials, lubricants, and hygienic design Prepare preventive maintenance master plans Identify roles and responsibilities Identify maintenance methods and tools Description GMaP ISO Documented cleaning procedures (facility, utilities, and equipment) are in place. B.B.3.1 8.5 The effectiveness of cleaning is verified. A cleaning master plan for equipment, including cleaning tools, is available. Cleaning tools are color-coded and clearly marked. B.B.3.2 Cleaning chemicals are marked and stored separately. Personnel who undertake cleaning and disinfection have been trained. B.B.3.3 8.6 Requirements Food contact surfaces are made of suitable materials (can be cleaned and disinfected). 8.1 Hygienic design requirements f o r equipment have been met. 8.2 Food contact surfaces are made of suitable materials (impermeable, free of rust and 8.3 corrosion, fit for temperature and holding conditions). 8.4 A preventive maintenance program is in place. 8.6 Corrective maintenance procedures are available. Temporary vs. permanent repair and the priorities of maintenance requests are identified. Lubricants and heat transfer fluids are food grade. Post-maintenance cleaning, sanitizing, and release; the pre-use inspection of processes and equipment are undertaken. Records required Equipment cleaning and maintenance records Hygiene control records for maintenance activities Food grade certificates for lubricants Post-maintenance inspection record and verification records; test results (where necessary) of maintenance Training of Training all staff and all staff Monitoring, Cleaning, recording, preventive andand inspection corrective maintenance activities Maintain & Update record of CAPA Monthlymanagement, Incident (if any) CAPA, and change control records at the Report at Report MRM (if the MRM necessary) (if necessary) Periodic review Periodic of maintenance review of program effectiveness the waste management system 10 INTRODUCTION 1.6. MANAGEMENT OF PURCHASED MATERIALS Assess current purchasing practices and norms Assessment & Implementation Make a list of all existing suppliers of both material and services Collect data on receiving criteria for materials and service agreements and contracts Review sampling, testing, and receive and reject processes Determine appropriate supplier selection processes and develop approved supplier list Plan to improve sampling, testing, and receive and reject processes (if needed) Develop a supplier performance appraisal program Implement a supplier selection program and conduct performance reviews Description GMaP ISO 9.3 Incoming material requirements: the condition of delivery vehicles is checked; materials areinspected and tested or are covered by certificates of analysis. A documented verification method has been established. Risk assessment and the frequency of inspection are defined. A procedure for handling materials that are out of specification is in place. Accessing, sampling, testing, and release procedures exist for bulk materials (if needed). Requirements 9.2 A supplier selection process is in place. I.A.13 An approved supplier list is available. I.A.14 Raw material specifications and receiving procedures are available and applied. A procedure for handling materials that are out of specification has been designated. The verification of supplier performance is conducted. Records required Incoming vehicles inspection records Raw materials inspection and testing records Sampling and testing records Out of specification handling records Test results and release records Updated, approved supplier list Supplier performance review records of staff Training of Training all staff involved in purchasing, receiving, and warehousing Maintain & Update Monitoring, Receiving, recording, sampling, andand inspection testing are ongoing as specified by procedures record of CAPA Monthlymonitoring Regular (if any)performance (at least annually) of supplier of the Report at Review MRM supplier (if necessary) performance and update of approved supplier list 11 INTRODUCTION 1.7. MEASURES FOR THE PREVENTION OF CROSS-CONTAMINATION Assess the hazards in each building, zone, and area; review and evaluate if barriers and routes are sufficient for the prevention of cross-contamination Review the potential of physical, chemical, microbial, and allergen cross-contamination through movement and the use of materials, including tools Develop an improvement plan for segregation and contamination control (if needed) Implement contamination control procedures Description GMaP ISO The risk of physical, chemical, and microbiological contamination of products is B.B.4 minimized 10.1 Physical barriers are established where needed (see also the PRP Layout of Premises 10.4 and the Workspace, GMaP: B.B.4, ISO: 5.1) The separation of raw materials from in-process and finished products Physical contamination control procedures (glass policy, inspection, breakagemanagement, and so on) The management of wooden pallets, tools, rubber seals, and personal protective Requirements clothing and equipment Zoning map and traffic routes (see also the PRP Layout of Premises and the Workplace, 10.2 GMaP: B.B.4, ISO: 5.1) A contamination hazard assessment is conducted in each area The access to high-risk zones is controlled A documented allergen management procedure is in place (related PRP: 1.14. Product B.C.2 10.3 Information and Consumer Awareness, GMaP: B.A.2.4; ISO: 1.7) Records required Glass, brittle materials inspection records Wooden pallet inspection records Allergen management records (for example, allergen cleaning record) of all Training of Training staff all staff Maintain & Update Monitoring, Regular recording, monitoring, and inspection cleaning and maintenance, and inspection Monthly Report record of incidents any) (if CAPA (if at any) the MRM Report at Periodic the MRM review (if necessary) control procedures of contamination 12 INTRODUCTION 1.8. CLEANING AND SANITIZING Assess current cleaning practices – Define types of cleaning: dry vs. wet; equipment cleaning in place vs. cleaning out of place Prepare cleaning and disinfection master plans Define roles and responsibilities Develop and implement cleaning methods Verify cleaning and sanitization program effectiveness Implement cleaning and sanitization program Description GMaP ISO Cleaning and sanitation master plan, including cleaning the cleaning tools, is established. Cleaning in place lines are separated from product lines. B.B.3.1 11.1 Cleaning in place and cleaning out of place plans, including cleaning parameters and criteria 11.4 to trigger cleaning, have been defined. Requirements Cleaning and sanitization verification program is in place. Equipment monitoring plan has been established (critical surfaces). 11.1 B.B.3.1 Post-cleaning inspections and pre–start-up inspections are set up. 11.3 Cleaning verification procedures are in place. 11.5 Cleaning tools are color-coded and marked. The storage of cleaning tools and cleaning and sanitation chemicals has been provided B.B.3.2 11.2 Methods for cleaning tools are defined. Trained, qualified people are involved in cleaning and disinfection. B.B.3.3. Records required Cleaning and sanitation records Cleaning in place and cleaning out of place records Cleaning verification records Cleaning validation records Training records Tool cleaning records Cleaning tools and cleaning and sanitation chemical inventory records Training of all staff of all staff Trainingcleaning, Regular sanitation, and inspection Maintain & Update Monitoring, recording, Environmental inspection and trends monitoring and CAPA Monthly Report atrecord of CAPA (if any) the MRM Report at Periodic the MRM review necessary) (ifcleaning of the and sanitation program 13 INTRODUCTION 1.9. PEST CONTROL Assess site situations (process, pest presence, site cleanliness, people’s behavior, and staff capability) and choose one option that is outsourced or in-house Outsourced In-house Identify pests at the site Identify pests at the site Conduct pest risk assessment Conduct pest risk assessment Assign person in charge of pest control Identify target pests Get quotation (including service specifications) Assign pest control team and leader Interview and select suppliers Train staff and acquire licenses Sign contracts Develop and implement solutions Description GMaP ISO B.B.5.1 12.1 Pest control procedures are in place, and there is no evidence of pest infestation on site A pest monitoring program that includes monitoring methods and devices, schedule, trap B.B.5.2 12.2 maps, records, trends, inspections, and actions is available. 12.5 Pest proofing and other harborage and infestation preventive measures are in place. 12.3 Regular inspections on the breach of pest proofing and signs of pest infestation are Requirements 12.4 conducted, and the findings lead to rectification. 12.6 Control procedures, including chemical controls, such as on baits and pesticides, have been established. Eradication is conducted if any infestation occurs, eradication records are maintained. List of approved chemicals, product information, and material safety data sheets are available. B.B.5.3 12.2 An inspection program is undertaken by a trained person at an appropriate frequency B.B.5.4 Licensing and legislative requirements on the use of chemicals are met. Records required Training records, licensing for pest controllers and in-house pest control team Pest risk assessment and list of target pests; pest trap layout map Daily or weekly monitoring records and monthly trends List of approved chemicals, product information, material safety data sheets Site inspection records, findings, CAPA, and closure of findings Training of all staff to ensure awareness and to report pest sightings Training of all staff Recording, trend reporting for the pest monitoring program, recommended actions (if needed) Maintain & Update Monitoring, recording, and inspection Regular site inspections, findings, and follow-up eradication actions Monthly record of CAPA (if any) Report at the MRM (if any significant issues) arise Report at Periodic the MRM review (if necessary) of pest management system effectiveness 14 INTRODUCTION 1.10. PERSONAL HYGIENE AND EMPLOYEE FACILITIES Assess whether employee facility requirements are fulfilled Assessment & Implementation Conduct risk assessments on hygiene Identify gaps and develop hygiene control procedures Implement procedures Description GMaP ISO Personal hygiene measures are applied for relevant contractors, visitors, and others. B.B.1.1 13.1 Sufficient dedicated handwashing stations with hands-free features, rest rooms with 13.2 handwashing and sanitizing facilities, changing facilities, eating and personal food storage areas are available. Personal hygiene requirements comply with legal requirements (if applicable). B.B.1.2 Hygiene procedures are communicated to employees, contractors, and visitors. B.B.1.3 Personnel are informed about how to report cases of Illness or injury. 13.6 A qualified person is assigned to manage health and hygiene controls on individuals. B.B.1.4 Requirements Pre-employment medical examinations and regular checkups on health status are 13.5 conducted. Personal hygiene requirements are communicated through visitor hygiene control forms, B.B.1.5 visual instructions, briefings, training, and refresher courses. Personal cleanliness is inspected regularly. 13.7 Procedures for checking and taking action, including retraining, are observed if 13.8 any improper personal behaviors (smoking, eating, and so on). Employees, contractors, and visitors are informed about requirements and procedures on B.B.1.6 uniforms and protective clothing. 13.4 Protective clothing (uniforms, shoes, gloves, and so on) meet hygiene requirements. Staff canteens and designated eating areas are located properly. 13.3 Records required Training and communication records Posters on handwashing and other hygiene controls Health and hygiene checkup records on employees Hygiene controls and personal property control forms that are to be completed before contractors and visitors enter the premises Copy of local regulations (if applicable) Employee health examination records (pre-employment and regular examinations) of all Training and Training staff communication among all staff, contractors, and visitors on health and hygiene requirements Maintain & Update Monitoring, Regular recording, monitoring, and inspection inspection, and follow-up actions for violations Monthly record of Report incidents any)(if CAPA (if atany) the MRM Report at Periodic the MRM reviews (if necessary) of program effectiveness 15 INTRODUCTION 1.11. REWORK Identify points of rework generation Define labelling requirements for rework Review storage, transport, expiration, and rework usage guidelines and develop an improvement plan (as needed) Implement rework procedures Description GMaP ISO Specifications are available for all product inputs (raw materials, ingredients, additives, B.A.1.1 14.1 packaging materials, rework) and finished products. Rework procedures with traceability for work in progress, post-treatment, and B.A.2.2 14.2 rework are established Storage areas have been assigned for rework. Labeling requirements for rework—label color and detailed information requirements on label (classification, date of generation, reason for rework, designation)—are defined and being implemented. Requirements Recording procedures for the generation, storage, and use of rework are in place. B.A.2.3 Handling procedures for the removal and segregation of packaging materials and 14.3 contamination controls while rework is being generated from packed products are active. Instructions for reuse (acceptable quantity, process steps, methods of addition, and 14.3 preprocessing if required) are clearly defined and communicated to personnel. Records required Specifications Training records on rework procedures Records of generation, storage, testing, and reuse or rejection of rework Hygiene and packaging materials control records for rework generated from packed products Training of Training all staff of all staff on awareness of rework handling Training ofgeneration, Recording all staff storage, and use of rework (ongoing) Maintain & Update Follow-up Training all inspection offor staff findings Report incidents Training (if any) at the MRM of all staff Training review Periodic of the waste management system of all staff 16 1.12. PRODUCT WITHDRAWAL AND RECALL Review if any withdrawal and recall procedures are in place and effective Develop and refine procedures and the roles and responsibilities of individuals for incidents Management Team Implement revised withdrawal and recall procedure Verify traceability and test effectiveness by conducting a mock recall Description GMaP ISO Affected products can be withdrawn and recalled. B.A.3 - Related FSMS Element 2.14. Traceability–GMaP: B.A.2, I.A.2; ISO: 8.3 B.A.2 - The effectiveness of the traceability system is tested at least annually and the I.A.2 system is updated I.A.3 - Related FSMS Element 2.19 Withdraw and Recall Records of incidents are maintained. Documented incident management system that addresses incident reporting, product I.A.3.3. withdrawal, and product recall is in place. 15.1 Products failing to meet required food safety standards can be identified, located, and removed Requirements from any point of the supply chain. Communication plan with designated responsible persons identified to provide information to I.A.3.4 15.2 customers, consumers, and regulatory authorities has been established. A list of key contacts in the event of a recall is available. Mock recall and internal and external incident communication have been tested. The incident management system is reviewed, tested, and verified at least once a year I.A.3.5 All incidents are recorded; their severity and consumer risks are assessed. I.A.3.6 15.2 If products are withdrawn because of immediate health hazards, the safety of other products produced under the same conditions must be evaluated. The need for public warnings should also be considered. Records required Incident reports (Incident management system) review record Mock recall reports Training of staff on withdrawal and recall procedures Maintain & Update Conduct a mock recall annually and maintain a record Report on the mock recall exercise at the MRM Periodic review of the effectiveness of the procedure 17 1.13. WAREHOUSING Review warehouse procedures and storage practices (including vehicles) Develop an implementation plan on good warehousing practices as needed Implement good warehousing practices Description GMaP ISO Facilities for the storage of food and ingredients are adequate. B.B.9.1 Food storage facilities are constructed of materials that can be cleaned and maintained. B.B.9.2 16.2 Separate storage areas for waste materials and chemicals has been established. 16.2 Separate areas or segregation of nonconforming materials. Appropriate transport is used to transport foods. B.B.9.3. 16.2 Warehouse temperature, humidity, and other environmental conditions are controlled. 16.3 Lower layers are protected (limiting stacking height, using pallets for ventilation, and so on) Specify first in, first out; first expired, first out. 16.2 Requirements A documented product transport procedure is available and effectively implemented. I.B.9.1 A documented transport vehicle procedure is available and effectively implemented. I.B.9.2 16.2 Gasoline- or diesel-powered fork-lifts are not allowed in food ingredient or food product areas. Documented maintenance and hygiene processes for vehicles and equipment for loading and I.B.9.3 unloading are available and effectively implemented. 16.3 Vehicles, conveyors, and containers are to be well-maintained and protect products against damage and contamination. 16.3 (Where the same vehicle is used for food and nonfood items), cleaning is carried out before use with food items. Dedicated bulk containers are used for food. Records required Records of food storage (with location ID) and transport Records on material receiving, storage, and use Records of temperature, humidity, and so on, for storage and food transport (as appropriate) Cleaning records (where necessary) Good warehousing practice review records Training of warehouse and related staff (dispensing, purchasing sections, and so on) Maintain & Update Regular monitoring, cleaning and maintenance, and inspection of storage areas and vehicles Report incidents (if any) at the MRM Periodic review of good warehousing practices 18 1.14. PRODUCT INFORMATION AND CONSUMER AWARENESS Review all labels and revise if necessary Review the label management process Develop an improvement plan for meeting labelling requirements and for label and information management Implement proper checks to ensure labelling requirements are met and label information is well managed Description GMaP ISO Clear labeling procedures are in place and ensure continuous B.A.2.4 identification of products through all stages of production and delivery. - Related FSMS Element 2.14. Traceability–GMaP: B.A.2, I.A.2; ISO: 8.3 - Related PRP 1.13. Warehousing–GMaP: B.A.9; ISO: 16 - Related PRP 1.7. Measures for the prevention of cross- contamination - (Allergen Control–GMaP: B.B.4.; ISO: 10.3) Requirements Labeling guidelines are available and meet legislative requirements 17 (if any). The information to be communicated with customers or consumers is clearly defined. Information is communicated with customers and consumers though labels and descriptions on contracts. Records required Bin cards, labels, and so on for raw materials through all stages up to finished product Finished product labels Samples of communication with customers through contracts Training of relevant staff (production, warehouse, procurement, marketing, and so on) Maintain & Update Regular controls on labelling Report incidents (if any) at the MRM Periodic review of labelling requirements 19 1.15. FOOD DEFENCE, BIO-VIGILANCE, AND BIOTERRORISM Establish a food defence team and define roles and responsibilities Identify threats in the environment and the process Perform a threat assessment and critical control point (TACCP) analysis and develop a relevant action plan Implement action plan Description GMaP ISO Assess the hazard to products posed by potential acts of sabotage, vandalism, or I.C.4.1 18.1 terrorism and implement proportional protective measures, such as the following: - The compound is well protected. - Access to the workplace is controlled by security guards at entrances. - Security patrols and closed-circuit television systems are active. Potentially sensitive areas within the establishment should be identified, mapped, 18.2 andsubjected to access controls. Requirements Where feasible, access should be physically restricted by use of locks, electronic card keys, or alternative systems. Points in the process that are vulnerable to intentional product tampering or I.C.4.2 intentionalcontamination have been identified and subjected to additional access controls. Control measures are in place to address what to do with products if I.C.4.3 prohibitedaccess has taken place and the product may have been tampered with or intentionally contaminated. Records required Threat assessment critical control point Hygiene and personal property control forms to be completed by contractors and visitors before they enter the premises (see also: 1.10 Personal Hygiene and Employee Facilities) Security personnel duty roster Training of food defence team and all staff Maintain & Update Regular security checks and ad hoc inspection if necessary Report incidents (if any) at the MRM Periodic review of effectiveness of the action plan 20 1.16. FOOD FRAUD Establish the food fraud team Map and verify the food supply chain Conduct a vulnerability assessment and critical control point (VACCP) analysis Determine VACCP points and mitigation actions Implementation and verification Documented information Description GMaP ISO List of members of the food fraud team 4.1 Supply chain flow chart Records of vulnerability assessment Records of risk assessment List of VACCP points Food fraud mitigation plan Food fraud review schedule Review food fraud program Record corrective action Verification and testing records Records required Vulnerability assessment Risk assessment Verification and testing records Records of corrective actions Training of food fraud team and related staff Maintain & Update Mitigation plan implementation, monitoring, and testing Root cause analysis and corrective action implementation Periodic review and updating 21 FOOD SAFETY MANAGEMENT SYSTEM 2.1 CONTEXT OF THE ORGANIZATION Identify internal and external context and issues Organizational context analysis tools Activity planning Monitoring and review Context of the organizational system requirements - A process for understanding key issues - Internal and external issues - Strengths, weaknesses, opportunities, and threats (SWOT) analysis - Relevancy to those that affect the intended results of the FSMS - Strategy and action plan to address issues Requirements - Monitoring and review of context - Update information - Record of the MRM GMaP ISO Clause ... 22000 Clause 4.1 no. no. Training of the team Monitoring, recording, reviewing, and updating Trends and CAPA Maintain & Update Report at the MRM Periodic review of the context 23 2.2. NEEDS AND EXPECTATIONS OF INTERESTED PARTIES Identify relevant interested parties Determine needs and expectations Rank interested parties in terms of power and interest Set objectives and priorities Monitoring and review Needs and expectations of interested parties: system requirements - Roles and responsibilities - Relevant interested party register - Ranking criteria; results of ranking; record - Objectives and priorities in addressing requirements - Regular review, monitoring, and updated information - Records of the MRM GMaP ISO Clause ... 22000 Clause 4.2 no. no. Training of all staff Monitoring, recording, reviewing, and updating Trends and record of CAPA Maintain & Update Report at the MRM Periodic review of interested parties 24 2.3. SCOPE OF THE FOOD SAFETY MANAGEMENT SYSTEM Determine the boundaries and applicability of the FSMS Specify the products and services, processes, and production sites Consider the context of the organization Maintain documented information Scope of the FSMS requirements - Boundaries and applicability of the FSMS - Processes, products, services, and production sites - Results of the SWOT and interested party analysis - Evaluation results on the influences of activities, processes, products, and services on food safety of end products - Documented information - Scheduled review GMaP ISO Clause ... 22000 Clause 4.3 no. no. Training of management and the food safety team Boundaries and applicability of the FSMS Updated SWOT and interested party analysis Maintain & Update Strategic directions of the organization Report at the MRM Periodic review of the scope of the FSMS 25 2.4. THE FOOD SAFETY MANAGEMENT SYSTEM Determination of FSMS processes Specify the products and services, processes, and production sites Define methods and criteria for each process Monitoring and evaluation of FSMS processes Improving FSMS processes Retain documented Information FSMS process: system requirements - Roles and responsibilities for each process - Processes and process Interactions - Process descriptions - Records of process monitoring - Key performance indicators GMaP ISO Clause 22000 I.A.10.1 Clause 4.4 no. no. Training of all process owners Process monitoring and implementation of key performance indicators Maintain & Update Implementation of corrective action Periodic review and updating 26 2.5. THE FOOD SAFETY POLICY Define food safety policy Approval and communication of the food safety policy Understanding the food safety policy Monitor and review of the food safety policy Update the food safety policy Maintain documented information Food safety policy: system requirements - Roles and responsibilities - Food safety policy - Communication plan and attendance - Records of policy communications - Records on policy understanding - Records of reviews and updates - Documented information GMaP ISO Clause 22000 ... Clause 5.2 no. no. Training of all staff Review and communication of policy Maintain & Update Periodic testing of policy understanding Periodic review and update of the policy 27 2.6. ORGANIZATIONAL ROLE, RESPONSIBILITY, AND AUTHORITY Define roles, responsibilities, and authority Approval and communication of responsibilities and authority Establishing the food safety team and the team leader Report on the performance of the FSMS Define the responsibility and authority to initiate and document actions Responsibility to report on problems in the FSMS to relevant individuals ISO 22000 Organizational role, responsibility, and authority: system requirements - Job description - Organigram/ Organization Chart - Team and team leader assignment letter - Report on FSMS performance - Letter of assignment and minutes to initiate and document action - Report on problems in the FSMS to relevant individuals GMaP ISO Clause 22000 ... Clause 5.3 no. no. Training of human resource staff, the food safety team, and the team leader FSMS performance reporting and review Maintain & Update Report problems and initiate document action Monitor, review, and update responsibilities and authority 28 2.7. RISKS AND OPPORTUNITIES Identification of risks and opportunities Evaluation and prioritization of risks and opportunities Define actions to address risks and opportunities Monitor, review, and update Documented information Risks and opportunities: system requirements - List of risks and opportunities - List of risks related to FSMS processes - Risk assessment process and methodology - Risks and opportunities mitigation action plan - Monitoring and review: records GMaP ISO Clause 22000 ... Clause 6.1 no. no. Training of management, team, and department managers Performance monitoring on risks and opportunities Management implementation Maintain & Update Corrective actions Regular review and update 29 2.8. FOOD SAFETY OBJECTIVES Establish food safety objectives which are consistent with food safety policy Establish specific, measurable, attainable (or achievable), realistic, and time-bound (SMART) food safety objectives that reflect food safety requirements Objectives should be defined at relevant functions and levels Planning to achieve food safety objectives Monitor, review, and update Documented information Food safety objectives: system requirements - Lists of FSMS objectives at relevant functions and levels - Links with food safety policy - Organizational and departmental baseline data - Action plan for achieving food safety objectives - Results of performance monitoring and evaluation GMaP ISO Clause 22000 ... Clause 6.2 no. no. Training managers Performance monitoring and evaluation of food safety objectives and Maintain & Update implementation Corrective action implementation Periodic review and update 30 2.9. CHANGE MANAGEMENT Establish the team Determine any changes in the FSMS (processes, procedures, inputs, resources, suppliers, personnel, output, interested parties, and so on) Determine the purpose and consequences of each change (risk and opportunity assessment of the changes) Planning the changes (consider the effects on the integrity of the FSMS, the allocation of resources, the staff, and so on) Communicate, implement, and monitor the changes Documented information Change management: system requirements - Changes generated by different sources - The need for the changes - Records on the risk and opportunity assessment of the proposed changes - Information for relevant interested parties - The results of implementation and monitoring - Maintain and retain documented information GMaP ISO Clause 22000 ... Clause 6.3 no. no. Training managers Risk and opportunity assessment of changes Maintain & Update Monitoring the implementations of the changes and corrective actions Periodic review and update 31 2.10. COMPETENCE Establish a process for assessing existing staff competencies and determine gaps in competence Determine the need for action Define actions to address the competence gaps, including any needs in training Implement actions Evaluate the effectiveness of the actions taken Documented information Competence: system requirements - A process to carry out competency assessment - Competence requirements for each job - Organigram - List of competence gaps - A multidisciplinary food safety team - Lists of actions to fill existing competency gaps - A list of all employees - Training needs assessments - Competency matrix, including training - Results of implementation and effectiveness evaluations - Competency evaluation records - Maintain and retain documented information GMaP ISO Clause 22000 B.A.9 Clause 7.2 no. I.A.9 no. Training of human resource and process managers Maintain & Update Implementation of a competency assessment process Monitoring the implementations and evaluation of actions Periodic review and upgrading 32 2.11. INFRASTRUCTURE Identify the infrastructure necessary for the FSMS and for process operations and control Evaluate the adequacy of the necessary infrastructure Provide the necessary infrastructure Maintain infrastructure to ensure continuing suitability Documented information Infrastructure: system requirements - Lists of necessary infrastructure - Resources plan and budget - Suitable infrastructure for FSMS and process operations - Preventive maintenance schedule - Maintenance procedures - Maintenance records - Maintenance orders - Trend analysis - Results of infrastructure monitoring and evaluation - Maintain and retain documented information See also 1.2. Layout of premises and the workspace GMaP ISO Clause 22000 ... Clause 7.1.3 no. no. Training a maintenance team Maintain & Update Implementation of preventive maintenance schedules and procedures Monitoring and corrective actions Periodic review and upgrading 33 2.12. WORK ENVIRONMENT Determine the resources needed for the establishment, management, and maintenance of the work environment necessary for the FSMS Provide and manage the work environment necessary for the FSMS and for product conformity Monitor and maintain the work environment needed Documented information Work environment: system requirements - A budget plan for the work environment - Lists of human and physical factors in the work environment - Regulations - Records of personal protective equipment provision and use - Results of monitoring and maintenance - Records on work environment inspections - Maintain and retain documented information See also 1.2. Layout of premises and the workspace and 1.10. Personal hygiene and employee facilities GMaP ISO Clause 22000 ... Clause 7.1.4 no. no. Training all staff and the occupational health and safety team Managing the work environment Maintain & Update Monitoring and maintenance Periodic review and updating 34 2.13. COMMUNICATION Identify internal and external communications relevant to the FSMS Define a communication plan on what, who, when, and how to communicate Communicate the plan and make the communication process transparent Monitor and control internal and external communications Documented information Communication: system requirements - Communication process and procedures - Communication plan - Records of communications with relevant interested parties - Results of monitoring and control - Documented information GMaP ISO Clause 22000 ... Clause 7.4 no. no. Training managers Communication plan implementation Maintain & Update Monitoring and control of communications Periodic review and updating 35 2.14. DOCUMENTED INFORMATION Identify the documented information required by the FSMS standard, the organization, and statutory and regulatory requirements Define methods for creating, identifying, reviewing, indexing, retrieving, and updating FSMS documented information Control documented information Monitor documented information Maintain and retain documented Information Documented information: system requirements - Lists of documented information - Creation and updating of procedures - Master lists of FSMS documents - Distribution lists - Results of monitoring and evaluation - Records on the management and retrieval of FSMS records - Documented information GMaP ISO Clause 22000 I.A.10.1 Clause 7.5 no. I.A.10.2 no. Training all staff Consistent implementation of procedures for the creation, updating, and control Maintain & Update of documented information Monitoring the process and corrective actions Periodic review and updating 36 2.15. TRACEABILITY Define a process and procedures for traceability Implement an identification and traceability system Monitor and test the traceability system Retain documented information Traceability: system requirements - Identification and traceability process and procedures - Unique identification codes - Records of raw materials in receiving, the production process, testing, monitoring, and dispatch - Records of product status - Schedule for testing and verification - Records of traceability testing and verification - Results of monitoring and control - Documented information See also 1.12. Product withdrawal and recall GMaP ISO Clause 22000 I.A.2 Clause 8.3 no. no. Training supply chain staff Periodic testing and verification Maintain & Update Process monitoring and control Periodic review and updating 37 2.16. EMERGENCY PREPAREDNESS AND RESPONSE Establish procedures to identify and respond to emergency situations and incidents Identify potential emergency situations and incidents Take steps to reduce the consequences of emergency situations and incidents Monitoring and periodical testing of procedures to respond to emergencies and incidents Review and revise emergency preparedness and response procedures Documented information Emergency preparedness and response: system requirements - A procedure to respond to emergency situations and incidents which shall also be aligned with Workplace Safety requirements - Lists of potential emergency situations and incidents - Emergency preparedness and response plan - Results and records of monitoring and periodical testing - Documented information GMaP ISO Clause 22000 ... Clause 8.4 no. no. Training all staff Implementation of emergency preparedness and response plan Maintain & Update Monitoring and periodic testing of procedures and corrective actions Periodic review and updating 38 2.17. CONTROL OF MONITORING AND MEASUREMENT Identify monitoring and measurement methods and equipment Establish a calibration and verification plan Ensure monitoring and measurement methods and equipment are reliable Monitor and verify monitoring and measurement methods and equipment Documented information Control of monitoring and measurement: system requirements - Lists of monitoring and measurement methods and equipment - Calibration and verification plan - Records of calibration and verification - Calibration status of each piece of equipment - Results and records of monitoring and verification - Documented information GMaP ISO Clause 22000 I.A.8 Clause 8.7 no. no. Training the quality, production, and maintenance team Implementation of the calibration and verification plan Maintain & Update Monitoring and verification of calibration and verification Periodic review and updating 39 2.18. NONCONFORMITY AND CORRECTIVE ACTIONS Identification of nonconformity Define methods to react to nonconformity Evaluate the need for actions to eliminate the causes of nonconformity Implement any necessary actions Review the effectiveness of any corrective actions taken Documented information Nonconformity and corrective action: system requirements - A procedure for handling nonconformity and corrective actions - Lists of nonconformities - Area for the segregation of nonconformity and quarantine - Records of root cause analysis and corrective actions - Action plan to eliminate causes of nonconformity - Records on the effectiveness of corrective actions - Documented information GMaP ISO Clause 22000 B.A.4 Clause 10.1 no. B.A.5 no. Training all staff Root cause analysis and implementation of corrective action Maintain & Update Monitoring and review of the effectiveness of corrective actions Periodic review and updating 40 2.19. WITHDRAWAL AND RECALL Identification of potential withdrawals and recalls Convene the withdrawal and recall team Evaluate the need for product withdrawal and quarantine Identify the batches affected, isolate stocks, and identify where the product has been distributed Notify relevant bodies and conduct product withdrawal or recall Review and verify the effectiveness of a withdrawal or recall Documented information Withdrawal and recall: system requirements - A procedure for withdrawals and recalls - List of the withdrawal and recall team - Minutes on decisions and actions - Distribution route and contact lists of direct customers - Records on quarantined products - Records of root cause analysis and corrective actions - Notification letter to authorities and customers - Press release and media communication - Templates of withdrawal and recall records - Documented information See also 1.12. Product withdrawal and recall GMaP ISO Clause 22000 B.A.3 Clause 8.9 no. I.A.3 no. Training the sales and recall team Maintain & Update Root cause analysis and implementation of corrective actions Monitoring and review of the effectiveness of withdrawal and recall Periodic review and updating 41 2.20. PERFORMANCE EVALUATION Define process monitoring, measurement, analysis, and evaluation Evaluate the performance and effectiveness of the FSMS Analysis and evaluation of data and information Review the FSMS Documented information Performance evaluation: system requirements - Monitoring and measurement plan - Records of monitoring and measurement - Internal audit (related FSMS Element 2.21. Internal Audit) - Results of data and information analysis - MRM schedule (related FSMS Element 2.22. Management Review Meeting) - FSMS review minutes - Records on corrective actions GMaP ISO Clause 22000 9.1 no. ... Clause 9.2 no. 9.3 Training the management and evaluation team Monitoring, measurement, analysis, and evaluation Maintain & Update Root cause analysis and implementation of corrective actions Periodic review and updating 42 2.21. INTERNAL AUDIT Form the internal audit team Conduct IFC internal audit training among the team Develop an internal audit plan Implement an internal audit program Internal audit: system requirements - Internal audit team - Internal audit master plan - Internal audit reports - CAPA and audit closures GMaP ISO Clause 22000 ... Clause 9.2 no. no. Communicate the internal plan to the organization Conduct internal audit according to the defined schedule Ensure the CAPA are effective and then close the audit Maintain & Update Report incidents (if any) at the MRM Periodically review the effectiveness of the internal audits 43 2.22. MANAGEMENT REVIEW MEETING Assess current communications in the organization Plan the MRM Implement the MRM MRM: system requirements - List the invitees - MRM presentation format - Meeting minutes - Action plan, CAPA, and closure - Evaluation whether the FSMS conforms to the food safety policy and meets the objectives of the FSMS GMaP ISO Clause 22000 ... Clause 9.3 no. no. Communicate the MRM plan to the organization Conduct the MRM according to the schedule Record decisions and action plans Maintain & Update Follow up on CAPA closures and continuous improvement Periodic review of the effectiveness of the MRM 44 HAZARD ANALYSIS CRITICAL CONTROL POINTS 3.1. DEVELOPMENT OF THE HACCP PLAN Assemble the food safety–HACCP team Describe food and the distribution of food Describe the intended use and the consumers of the food Develop a flow diagram that describes the process Verify the flow diagram (Worksheet 3) Define the scope of the HACCP (Worksheet 1) Describe the product and ingredients (Worksheet 2) Analyze the hazards at each process step (Worksheet 4) Use a decision tree and select operational PRPs (OPRPs) and critical control points (CCPs) (Worksheet 5) Validate control measures (Worksheet 6) Finalize the HACCP plan, including identified control measures, critical limits, corrective actions, and responsibilities (Worksheet 7) Verify the HACCP plan (Worksheet 8) Refer to 3.2 for system and training requirements Train OPRP and CCP operators on control and actions Overview of HACCP training for all staff Maintain records on OPRPs and CCPs (ongoing) Corrections and corrective actions, the if/when parameter is out of critical control limits Maintain & Update Follow up with CAPA to close incidents Periodic review of HACCP plan effectiveness 46 3.2. HACCP SYSTEM REQUIREMENTS Description GMaP ISO Business is in compliance with regulatory and customer requirements related to processes B.C.1 and products The HACCP plan is in place, as follows: I.C.3 8.5.4.1 Food safety hazards are to be controlled at the OPRP and CCP 8.5.4.2 Critical limits are set at the CCP or the action criteria for the OPRP Monitoring procedures Correction to be made if critical limits or action criteria are not met Responsibilities and authorities The HACCP monitoring plan is in place, as follows: 8.5.4.3 Measurements or observations that provide results within an adequate time frame Monitoring methods or monitoring devices are used Applicable calibration methods or, for the OPRPs, equivalent methods for the verification of reliable measurements or observations Monitoring frequency Monitoring results Responsibility and authority for monitoring Responsibility and authority for the evaluation of monitoring results Action plan to ensure the following: 8.5.4.4 System & Training Requirements Potentially unsafe products are not released The cause of nonconformities is identified The parameters controlled at the CCP or by the OPRP are within the critical limits or action criteria Recurrence is prevented Updates are undertaken in the HACCP plan if/when changes occur in the following: 8.6 Characteristics of raw materials, ingredients, and product contact materials Characteristics of end products Intended use Flow diagrams and descriptions of processes and the process environment Controls and calibration of monitoring and measurement equipment are in place 8.7 A verification plan is in place 8.8 Training requirements • IFC Food Safety Handbook, HACCP training for food safety, HACCP team • CCP and OPRP training for relevant staff who deal with CCPs or OPRPs • Training in the HACCP plan for all staff • Refresher training at least annually Records required Letter of appointment for the food safety–HACCP team Product descriptions (including raw materials, packaging materials, finished products,and storage and distribution conditions), intended product use, target consumers Process flow diagram and verification record Hazard analysis HACCP plan and verification records OPRP and CCP monitoring records Corrective action records Calibration records for testing and measuring devices at the CCPs Relevant training records 47 ANNEXES ANNEX 1: TIPS FOR VIRTUAL TRAINING AND COACHING Assess, train, coach, and reassess is the model IFC • Use continuous improvement tools to support the food safety team uses in delivering advisory services. development of the developer. Specialists and consultants should ensure that they • Identify additional advisors or services the have reviewed the assessment thoroughly so that developer may need. attention is tailored during training and coaching. • Be available by e-mail and phone as needed. Because the COVID-19 pandemic has imposed travel • Review the assessment results and report on them restrictions, the modality of service delivery has prior to the first session. changed and become mostly virtual or a mixture • Provide guidance as appropriate to address of virtual and face-to-face training and coaching. questions and concerns. While virtual delivery saves on trips to the food • Track sessions and progress. business, specialists and consultants obviously need • [Add as desired] to spend additional effort and energy on thorough preparation, delivery, and summary analysis. They And the coachee will undertake the following: also need to be more flexible and adaptable in • Commit to seeking to understand and apply the managing the challenges compared with face-to- face training and coaching. continuous improvement tools. • Commit to and follow through on strategic action Virtual training plan next steps. Tips that the consultant can use in virtual training • Understand that there are no guaranteed results, are as follows: even if the work is done. • Do not create virtual relationships; create real • Provide input on coaching session agendas. relationships virtually (reference: The Modern • Be prepared for, schedule, and ensure that the Virtual Classroom Experience: Facilitating the appropriate people are present, attend, and Experience: Developing Competence and Creating actively participate in all coaching sessions. Engagement, link to Amazon provided below) • Create, update, and maintain the strategic action • Pay attention to these five competencies of a plan. trainer-facilitator—virtual classroom fluency, • Inform the coach of any changes that may impact digital literacy, cultural intelligence, time the progress toward the goals. management, and adult learning principles. • Inform the coach at least 48 hours in advance if • Manage risks—technology risks and people they cannot participate in the session. problems or behavioral risks (attached: disaster • [Add as desired] prevention tips and an infographic). • In virtual training, develop whenever possible a How to prepare technically for virtual coaching checklist for the facilitator and the producer and In coaching virtually, specialists and consultants define roles and responsibilities, including details need to consider the following: on pre-session, online session, and post-session • Choose a platform where the audience can see activities. • Maintain interactive training as much as possible. face-to-face, access the session through various • Do not forget to undertake icebreaker, stretching, audio options (phone, computer), and share or Yoga activities in the virtual classes. screens and documents. • Create a shared space (SP, OneDrive, Dropbox) where documents may be shared. • Plan to capture the discussions and action plan. https://tinyurl.com/xjspse8 Use meeting memos or a shared document to record this material, update between sessions, and follow up during the next section. • Check often throughout the call that the Virtual coaching connection is good and that the other person is This is the point at which specialists and able to view the shared screen. consultants switch roles from trainer to coach. • Use various features available on the platform to Clearly communicate with the client team that the engage the participants. specialists or consultants will now take on the role of • Log into the call early. coach and will perform the following: • Prepare agendas for coaching sessions in advance How to prepare a conducive learning and in consultation with the coachees. environment • Arrive with the materials and mindset to deliver Virtual learning requires more effort by coaches, professional coaching services. too. Consultants are also encouraged to prepare the • Attend all coaching sessions as planned. • Inform the developer at least 48 hours in advance if learning environment as much as possible. they cannot attend a session. 49 ANNEX 1: TIPS FOR VIRTUAL TRAINING AND COACHING • A coaching session that is too long will exhaust the • Set action items for the next session coaches and risk losing the focus of the sessions. • Wrap up and assess the session The recommended duration and frequency are as After sessions: follows: • Share the documentation captured during the • Twice a week for one hour a day or once a week for session two hours a day • If the session lasts for two consecutive hours, add How to engage the participants during coaching a five-minute break after one hour Start each session by asking a few check-in questions • As often and as practical as possible, allow fewer to gauge the mood and mindset of participants. people to connect individually through their Examples of check-in questions include the following: own devices to lower network connection issues • How did the last session affect you and your work? and to create a learning environment together; • What is challenging you today? for instance, use a conference room where the • What is the one accomplishment you want to majority can gather together. achieve through today’s session? • Include relevant personnel, depending on the Ask questions such as the following: subject of the coaching session (such as waste • What progress are you making on your action management, purchasing, and so on) items? • Use a platform that is user friendly, that is, it • What challenges have you faced? takes into account the limitations of some groups • Do we need to revise the plan or adjust how we of people, for instance, people with special needs. view deadlines? • What lessons have you learned in working on your How to prepare the coachees action items? Before starting the delivery of the coaching: • What continuous improvement tools did you use? • Spend time assessing the knowledge of Use features available on the platform: participants on food safety. • The chat function to comment or raise question • Ensure the coach knows which type of participants without disturbing the flow of discussion will be present and adapt the delivery form • Use the hand raising function to get the coach’s accordingly (for example, talking speed, the attention and ask or answer a question or make a mandatory use of video by the trainer in the case comment of people with special needs. • Create a poll or a multiple choice exercise for decision-making How to plan a coaching session • Use whiteboard or annotation to share comments The coaches are encouraged to have a planning and opinions, and so on session with the coachee before coaching begin to nail the following things down: In addition to the above, the four Ps help them • What are the goals of the coaching sessions? identify what participants want to achieve and why. • When and how frequently should the sessions be • Position: What position (or goal) do you want to held? achieve? • Where should the sessions be held? • Problem: What problems or challenges are you • What is the measure of success? encountering? • Who should attend? • Possibilities: What are the possible solutions to • Has everyone taken the required courses? this problem? • Plan: How do you plan to implement the chosen How to conduct a coaching session solution? Before sessions: Thinking about the problem in this order helps avoid • Ensure that the meeting logistics are clearly incorrect assumptions and incorrect conclusions. It agreed and communicated. also helps the developer learn a structured problem- • Prepare by reviewing documentation and listing solving approach. any questions. During sessions: Remember the following: • Make introductions • Be the coach. The task is to coach and mentor, not • Check in on the developer’s frame of mind using to do the work. key coaching questions—attitude, challenges, and • Celebrate success. Take time to congratulate each success other. • Clarify the objectives of the coaching session • Help identify additional resources or training • Review the outcomes and action items of the needs. You do not need to be the only resource or previous session trainer. • Address the meeting content specific to the • Above all, help leaders understand that proficiency session building is a continual process, not a one-time 50 ANNEX 2: SCHEDULING AND PROJECT TRACKING Objectives consultant, but also on the client’s ambition The IFC food safety team has prepared a tracker for certification, the resources available, and the for planning and keeping track of the project. The capacity of the assigned personnel. objective of tracking food safety projects is to • In preparing the schedule, the modality of understand the progression of projects across the training and coaching (face-to-face, virtual, or a board as well as to provide support for projects that combination) should also be considered so that an are slow in achieving progress. adequate time can be allocated for activities. • The Excel file includes two worksheets. The How to use this project tracker first is a project tracker, and the second is list of • This tool is to be used as a guideline for scheduling the documented information required for GMaP, and tracking the progress of advisory service ISO22000-2018, and ISO 22002-TS. delivery. • The tracker is prepared in the Excel format with • It is recommended that a mutually agreeable the following columns. However, the specialist or implementation plan be prepared with the client consultant may make necessary adjustments. food safety team—set a clear timeline, identify - The activities required to meet the GFSI the milestones in major activities, and update the checklist schedule regularly. - The respective GFSI clause • In case of any unforeseen circumstances that - Task leads: the consultant and food safety might cause a delay in the project or if there are team lead or designated client team member any changes in ownership of activities, the tracker - Target deadline should be updated. - (Revised deadline) • Most of the PRPs, HACCP, and FSMS elements - Status can be scheduled in parallel, but successful - Notes implementation is based not only on the • Project tracker 51 PROJECT TRACKER IFC ADVISORY TIMELINE FOR FOOD SAFETY IMPLEMENTATION Update O = Outstanding / En retard C = Completed / Acheve Task Revised GFSI Task Phase Activity Lead Deadlines deadlines Status Notes clause Lead IFC Client (if any) 1,0 Food Safety Initial Assessment 1,1 Conduct baseline assessment 1,2 Provide Food Safety Assessment report with action plan and summary 1,3 Review results of baseline assessment with Senior Management 2,0 IFC Food Safety Courses 2,1 Provide IFC Food Safety Foundation course 2,2 Provide IFC Food Safety 52 Handbook Training 2,3 Provide training for internal auditors 3,0 Develop and implement prerequisite programs (PRP) against ISO/TS 22002-1 (clauses 4-18); ISO 22000 clause 8.2 and FSSC additional req. Deadline for Deadline for Document Infrastructure Development & Upgrades Implementation Completion 3,1 Construction and layout B.B.2 of buildings/ PRP4; Clause 8.2.4.a 3,2 Layout of premises and B.B.2 workspaces; zoning/ PRP 5; Clause 8.2.4.b 3,3 Utilities - air, water, ener- B.B.6 gy; other utilities/ PRP6; Clause 8.2.4.c 3,4 Waste disposal; sewage B.B.8 disposal and supportive services/ PRP7 3,5 Equipment suitability, B.A.8; cleaning and maintenance/ I.A.8; PRP8; Clause 8.2.4.e I.B.10 PROJECT TRACKER IFC ADVISORY TIMELINE FOR FOOD SAFETY IMPLEMENTATION Update O = Outstanding / En retard C = Completed / Acheve Task Revised GFSI Task Phase Activity Lead Deadlines deadlines Status Notes clause Lead IFC Client (if any) Deadline for Deadline for Document Infrastructure Development & Upgrades Implementation Completion 3,6 Management of purchased I.A.13; materials (supplier I.A.14; approval; reception; B.A.1 specifications)/ PRP9; 8.2.4 f and g 3,7 Measures for prevention B.B.4; of cross contamination/ B.C.2; PRP10; Clause 8.2.4.h (FSSC see below-Allergen) 3,8 Cleaning and Sanitizing B.B.3 (disinfection)/ PRP11 ; Clause 8.2.4.i 53 3,9 Pest Control/ PRP12; Clause B.B.5 8.2.4.d 3,10 Personnel hygiene and B.B.1; employee facilities/ PRP13; B.B.7 Clause 8.2.4.j 3,11 Rework/ PRP14 3,12 Product recall procedures/ PRP15 3,13 Warehousing/ PRP16; B.B.9; Clause 8.2.4.g I.B.9 3,14 Product information & con- sumer awareness/ PRP17; Clause 8.2.4.k 3,15 Food defence, biovigilance I.C.4 and bioterrorism/ PRP18. FSSC 2.5.3 Food defence plan (threat assessment, Plan) 3,16 Verification of PRPs (ISO 22000 requirements - Clause 8.2.4 and 8.8) 3,17 Updating the information specifying the PRPs/ (ISO 22000; Clause 8.6) PROJECT TRACKER IFC ADVISORY TIMELINE FOR FOOD SAFETY IMPLEMENTATION Update O = Outstanding / En retard C = Completed / Acheve Task Revised GFSI Task Phase Activity Lead Deadlines deadlines Status Notes clause Lead IFC Client (if any) 4,0 Develop and implement FSMS ISO 22000: 2018 4,1 Context of the organization ( FSMS scope, interested parties)/ Clause 4.1- 4.4 4,2 Leadership and commit- B.A.6: ment/ Clause 5.1 I.A.6 4,3 Food Safety policy and it’s communication/ Clause 5.2 4,4 Organizational roles, re- sponsibilities and authori- ties/ Clause 5.3 54 4,5 Planning, Risk and Oppor- tunities, Planning changes/ Clause 6.1 and 6.3 4,6 FSMS Objective/ Clause 6.2 4,7 Support; Resources/ Clause 7.1 ( 7.1.1-7.1.6) 4,8 Competence and Aware- B.A.9; ness/ Clauses 7.2- 7.3 I.A.9 4,9 Communication (Internal, External)/ Clause 7.4 4,10 Documented Information/ B.A.7.; Clause 7.5 I.A.7; I.A.10 4,11 Operation; Planning and control/ Clause 8.1 4,12 Prerequisite programmes/ Clause 8.2; See phase 3.0 above PROJECT TRACKER IFC ADVISORY TIMELINE FOR FOOD SAFETY IMPLEMENTATION Update O = Outstanding / En retard C = Completed / Acheve Task Revised GFSI Task Phase Activity Lead Deadlines deadlines Status Notes clause Lead IFC Client (if any) 4,13 Traceability system/ Clause B.A.2; 8.3 I.A.2 4,14 Emergency preparedness B.A.3; and response/ Clause 8.4 I.A.3: 4,15 Control of Monitoring and B.A.8; Measuring/ Clause 8.7; See I.A.8 above phase 3.5 4,16 Control of product and B.A.4; process nonconformities/ I.A.12 Clause 8.9 4,17 Correction and corrective B.A.5; 55 Actions; complaints han- I.A.11 dling/ clause 8.9.2-8.9.3 4,18 Handling of potentially un- safe products/ Clause 8.9.4 4,19 Withdrawal/recall/ Clause 8.9.5; see above phase 3.12 ( PRP 15) 4,20 Performance Evaluation (Monitoring, measuring, analysis and evaluation)/ Clause 9.1 4,21 Internal audits/ Clause 9.2 4,22 Management Review/ 9.3 4,23 Improvement; Continual/ Clause 10.2 4,24 Improvement; Non-con- formity and corrective action/ Clause 10.1 4,25 Update of the FSMS/ Clause 10.3 PROJECT TRACKER IFC ADVISORY TIMELINE FOR FOOD SAFETY IMPLEMENTATION Update O = Outstanding / En retard C = Completed / Acheve Task Revised GFSI Task Phase Activity Lead Deadlines deadlines Status Notes clause Lead IFC Client (if any) 5,0 HAZARD Control; ISO 22000 Clause 8.5; Clause 8.6; Clause 8.8 5,1 Preliminary Steps to enable hazard analysis/ Clause 8.5.1 5,2 Characteristics of raw materials, ingredients, contact materials and end product; Intended Use/ Clause 8.5.1.2; Clause 8.5.1.3; Clause 8.5.1.4 5,3 Production processes 56 flow-charts and on-site verification/ Clause 8.5.1.5.1; Clause 8.5.1.5.2 5,4 Description of process and process environment/ Clause 8.5.1.5.3 GFSI 5,5 Hazard analysis; B.C.1 & Hazard identification I.C.3 and determination of acceptable level/ Clause 8.5.2; Clause 8.5.2.1; Clause 8.5.2.2 5,6 Hazard assessment/ Clause 8.5.2.3 5,7 Selection and categorization of control measure(s)/ Clause 8.5.2.4 5,8 Validation of Control measures and combination of control measures/ Clause 8.5.3 5,9 Hazard Control Plan (HACCP/OPRP Plan); CCP and OPRP/ Clause 8.5.4.1 PROJECT TRACKER IFC ADVISORY TIMELINE FOR FOOD SAFETY IMPLEMENTATION Update O = Outstanding / En retard C = Completed / Acheve Task Revised GFSI Task Phase Activity Lead Deadlines deadlines Status Notes clause Lead IFC Client (if any) 5,10 Determination of Critical Limits for each CCP and action criteria for OPRP/ Clause 8.5.4.2 5,11 Monitoring system at CCPs and OPRPs/ Clause 8.5.4.3 5,12 Action when critical limits or action criteria are not met/ Clause 8.5.4.4. 5,13 Implementation of hazard 57 control plan/ clause 8.5.4.5 5,14 Updating the information specifying the Hazard con- trol plan/ Clause 8.6 5,15 Verification of Hazard control Plan(analysis of ver- ification results)/ clause 8.8 6,0 Performance Evaluation 6,1 Conduct internal audit along with trained internal auditors/ 6,2 Conduct Management Review Meeting/ 7,0 Food Safety Final Assessment 7,1 Product labelling/ 2.5.2 - see above phase 5.2 7,2 Food defence plan (threat I.C.4 assessment, Plan)/ 2.5.3 - See above phase 3.15 PROJECT TRACKER IFC ADVISORY TIMELINE FOR FOOD SAFETY IMPLEMENTATION Update O = Outstanding / En retard C = Completed / Acheve Task Revised GFSI Task Phase Activity Lead Deadlines deadlines Status Notes clause Lead IFC Client (if any) 7,0 Food Safety Final Assessment Food Fraud (Vulnerability 7,3 assessment, Food fraud mitigation plan)/ 2.5.4 7,4 Logo use/ 2.5.5 58 B.B.4; Allergen management B.C.2; 7,5 (plan)/ 2.5.6 - See above phase 3.7 Environmental Monitoring 7,6 - Plan/ (category C, I, K) 59 © International Finance Corporation 2020. 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