FSSC 22000 Version 5 Audit Checklist

Use the FSSC 22000 Version 5 Audit Checklist for comprehensive food safety audits, ensuring compliance with industry safety standards and regulations.

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FSSC 22000 Version 5 Audit Checklist

12.1 General Requirements

12.2 Pest Control Programmes

12.3 Preventing Access

12.4 Harbourage And Infestations

12.5 Monitoring And Detection

1. Do pest-monitoring programs include placing detectors and traps in key locations to identify pest activity, maintaining a map of detectors and traps, and ensuring detectors and traps are of robust, tamper-resistant construction and appropriate for the target pest?

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12.6 Eradication

2. Is pesticide use and application restricted to trained operatives and controlled to avoid product safety hazards, with records of pesticide use maintained to show the type, quantity, and concentrations used; where, when, and how applied; and the target pest?

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13.1 General Requirements

13.2 Personnel Hygiene Facilities And Toilets

4. Do personnel hygiene facilities have the following: • employee hygiene facilities that do not open directly onto production, packing, or storage areas • have adequate changing facilities for personnel • have changing facilities sited to enable personnel handling food to move to the production area in such a way that risk to the cleanliness of their workwear is minimized.

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13.3 Staff Canteens And Designated Eating Areas

13.4 Workwear And Protective Clothing

13.5 Health Status

13.6 Illness And Injuries

13.7 Personal Cleanliness

1. Are personnel in food production areas required to wash and, where required, sanitize hands for the following: • before starting any food-handling activities • immediately after using the toilet or blowing the nose • immediately after handling any potentially contaminated material

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13.8 Personal Behavior

2. Are control measures presented for permitted jewelry, permissibility of personal items in designated areas only, prohibition of certain cosmetic practices, prohibition of carrying of writing implements behind the ears, maintenance of personal lockers, and prohibition of storage of product contact tools and equipment in personal lockers?

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14.1 General Requirements

14.2 Storage, Identification, And Traceability

14.3 Rework Usage

15.1 General Requirements

15.2 Product Recall Requirements

16.1 General Requirements

16.2 Warehousing Requirements

16.3 Vehicles, Conveyances, And Containers

17. Product Information And Consumer Awareness

18.1 General Requirements

18.2 Access Controls

2.5.1 Management Of Services And Purchased Materials

1. In addition to clause 7.1.6 of ISO 22000:2018, does the organization ensure that where laboratory analysis services are used for the verification and/or validation of food safety, these shall be conducted by a competent laboratory (including both internal and external laboratories as applicable) that has the capability to produce precise and repeatable test results using validated test methods and best practices? (e.g. successful participation in proficiency testing programs, regulatory-approved programs, or accreditation to international standards such as ISO 17025)

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2. For food chain categories C, D, I, G, and K, do the following additional requirements apply to ISO 22000:2018 clause 7.1.6? Does the organization have a documented procedure for procurement in emergency situations to ensure that products still conform to specified requirements and the supplier has been evaluated?

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3. In addition to ISO/TS 22002-1:2009 clause 9.2, does the organization have a policy for the procurement of animals, fish, and seafood that are subject to control of prohibited substances? (e.g. pharmaceuticals, veterinary medicines, heavy metals, and pesticides)

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4. For food chain categories C, D, I, G, and K, do the following additional requirements apply to ISO /TS 22002-1 clause 9.2; ISO/TS 22002-4 clause 4.6 and ISO/TS 22002-5 clause 4? Does the organization establish, implement, and maintain a review of product specifications to ensure continued compliance with food safety, legal, and customer requirements?

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2.5.2 Product Labeling

1. n addition to clause 8.5.1.3 of ISO 22000:2018, does the organization ensure that finished products are labeled according to all applicable statutory and regulatory requirements in the country of intended sale, including allergen and customer-specific requirements?

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2.5.3 Food Defense - 2.5.3.1 Threat Assessment

2.5.3 Food Defense - 2.5.3.2 Plan

2.5.4 Food Fraud Mitigation - 2.5.4.1 Vulnerability Assessment

2.5.4 Food Fraud Mitigation - 2.5.4.2 Plan

2.5.5 Logo Use

3. Is the certified organization not allowed to use the FSSC 22000 logo, and is any statement or reference to its certified status on: • a product • its labeling • its packaging (primary, secondary, or any other form) • in any other manner that implies FSSC 22000 approves a product, process, or service

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2.5.6 Management Of Allergens (Food Chain Categories C, E, FI, G, I & K)

2.5.7 Environmental Monitoring (Food Chain Categories C, I & K)

1. Does the organization have the following in place: • Risk-based environmental monitoring program • Documented procedure for the evaluation of the effectiveness of all controls on preventing contamination from the manufacturing environment and this shall include, at a minimum, the evaluation of microbiological and allergen controls present • Data of the monitoring activities including regular trend analysis

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2.5.8 Formulation Of Products (Food Chain Category D)

2.5.9 Transport & Delivery(Food Chain Category FI)

2.5.10 Storage & Warehousing (All Food Chain Categories)

2.5.11 Hazard Control & Measures For Preventing Cross-Contamination (Food Chain Categories C & I)

2.5.12 PRP Verification (Food Chain Categories C, D, G, I & K)

2. The organization shall establish, implement, and maintain routine (e.g. monthly) site inspection/PRP checks to verify that the site (internal and external), production environment, and processing equipment are maintained in a suitable condition to ensure food safety.

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3. The organization shall establish, implement, and maintain routine (e.g. monthly) site inspection/PRP checks to verify that the site (internal and external), production environment, and processing equipment are maintained in a suitable condition to ensure food safety.

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2.5.13 Product Development (Food Chain Categories C, D, E, F, I & K)

2. Does this include the following: • Evaluation of the impact of the change on the FSMS taking into account any new food safety hazards (incl. allergens) introduced and updating the hazard analysis accordingly • Consideration of the impact on the process flow for the new product and existing products and processes • Resource and training needs • Equipment and maintenance requirements • The need to conduct production and shelf-life trials to validate product formulation and processes are capable of producing a safe product and meet customer requirements

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2.5.14 Health Status (Food Chain Category D)

2.5.15 Requirements For Organizations With Multi-Site Certification (Food Chain Categories A, E, FI, & G) - Central Function

1. Does the management of the central function ensure that sufficient resources are available and that roles, responsibilities, and requirements are clearly defined for management, internal auditors, technical personnel reviewing internal audits, and other key personnel involved in the FSMS?

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Nternal Audit Requirements

4. Do internal auditors meet at least the following requirements and this shall be assessed by the CB annually as part of the audit: • Work experience - 2 years of full-time work experience in the food industry including at least 1 year in the organization • Education - completion of a higher education course or in the absence of a formal course, have at least 5 years of work experience in the food production or manufacturing, transport, and storage, retailing, inspection, or enforcement areas • Training - For FSSC 22000 internal audits, the lead auditor shall have successfully completed FSMS, QMS, or FSSC 22000 Lead Auditor Course for 40 hours. • Other auditors in the internal audit team shall have successfully completed an internal auditor course of 16 hours covering audit principles, practices, and techniques. The training may be provided by the qualified internal • Lead Auditor or through an external training provider. • FSSC scheme training covering at least ISO 22000, the relevant prerequisite programs based on the technical specification for the sector (e.g. ISO/TS 22002-x; PAS-xyz), and the FSSC additional requirements - minimum 8 hours. • Internal audit reports shall be subject to a technical review by the central function, including addressing the non-conformity resulting from the internal audit. • Technical reviewers shall be impartial, have the ability to interpret and apply the FSSC normative documents (at least ISO 22000, the relevant ISO/TS 22002-x, PAS-xyz, and the FSSC additional requirements), and have knowledge of the organization's processes and systems. • Internal auditors and technical reviewers shall be subject to annual performance monitoring and calibration. • Any follow-up actions identified shall be suitably actioned in a timely and appropriate manner by the Central function.

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4.1 General Requirements

4.2 Environment

4.3 Locations Of Establishments

5.1 General Requirements

5.2 Internal Design, Layout, And Traffic Patterns

5.3 Internal Structures And Fittings

5.4 Location Of Equipment

5.5 Laboratory Facilities

5.6 Temporary Or Mobile Premises And Vending Machines

5.7 Storage Of Food, Packaging Materials, Ingredients And Non-food Chemicals

6.1 General Requirements

6.2 Water Supply

6.3 Boiler Chemicals

6.4 Air Quality And Ventilation

6.5 Compressed Air And Other Gases

6.6 Lighting

7.1 General Requirements

7.2 Containers For Waste And Inedible Or Hazardous Substances

1. Are containers for waste and inedible or hazardous substances meet the following: • clearly identified for their intended purpose • located in a designated area • constructed of impervious material that can be readily cleaned and sanitized • closed when not in immediate use • locked where the waste may pose a risk to the product

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7.3 Waste Management And Removal

2. Are labeled materials, products, or printed packaging designated as waste disfigured or destroyed to ensure that trademarks cannot be reused, with removal and destruction carried out by approved disposal contractors, and do organizations retain records of destruction?

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7.4 Drains And Drainage

1. Are drains designed, constructed, and located so that the risk of contamination of materials or products is avoided, with drains having sufficient capacity to remove expected flow loads, not passing over processing lines, and drainage direction not flowing from a contaminated area to a clean area?

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8.1 General Requirements

8.2 Hygienic Design

1. Does the equipment meet the following established principles of hygienic design: • smooth, accessible, cleanable surfaces, self-draining in wet process areas • use of materials compatible with intended products, and cleaning or flushing agents • framework not penetrated by holes or nuts and bolts? • piping and ductwork which is cleanable, drainable, and with no dead ends? • equipment designed to minimize contact between the operator's hands and the products?

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8.3 Product Contact Surfaces

8.4 Temperature Control And Monitoring Equipment

8.5 Cleaning Plant, Utensils And Equipment

2. Do the cleaning programs specify what is to be cleaned, including drains, the responsibility, the method of cleaning (e.g., CIP, COP), the use of dedicated cleaning tools, removal or disassembly requirements, and methods for verifying the effectiveness of the cleaning?

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8.6 Preventive And Corrective Maintenance

9.1 General Requirements

9.2 Selection And Management Of Suppliers

2. Does the process for supplier selection include an assessment of the supplier's ability to meet quality and food safety expectations, requirements, and specifications, with examples such as an audit of the supplying site prior to accepting materials for production or appropriate third-party certification?

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9.3 Incoming Material Requirements (Raw/ingredients/Packaging)

10.1 General Requirements

10.2 Microbiological Cross-contamination

2. Is a hazard assessment carried out to determine potential contamination sources, susceptibility of the product, and control measures suitable for these areas: • separation of raw from finished or ready-to-eat (RTE) products • structural segregation — physical barriers, walls, or separate buildings • access controls with requirements to change into required workwear • traffic patterns or equipment segregation — people, materials, equipment, and tools (including the use of dedicated tools) • air pressure differentials

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10.3 Allergen Management

2. Are products protected from unintended allergen cross-contact by cleaning and line change-over practices and/or product sequencing, with rework containing allergens used only in products containing the same allergens by design or through a process demonstrated to remove or destroy the allergenic material?

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10.4 Physical Contamination

2. Based on hazard assessment, are measures put in place to prevent, control, or detect potential contamination, including adequate covers over equipment or containers for exposed materials or products, use of screens, magnets, sieves, or filters, and use of detection or rejection devices such as metal detectors or X-ray?

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11.1 General Requirements

11.2 Cleaning And Sanitizing Agents And Tools

11.3 Cleaning And Sanitizing Programmes

2. Do cleaning and/or sanitizing programs specify the following: • areas, items of equipment, and utensils to be cleaned and/or sanitized • responsibility for the tasks specified • cleaning/sanitizing method and frequency • monitoring and verification arrangements • post-clean inspections • pre-start-up inspections

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11.4 Cleaning In Place (CIP) Systems

11.5 Monitoring Sanitation Effectiveness

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FSSC 22000 Version 5 Audit Checklist

Use the FSSC 22000 Version 5 Audit Checklist for comprehensive food safety audits, ensuring compliance with industry safety standards and regulations.

1. Are hygiene, cleaning, incoming materials inspection, and monitoring procedures implemented to avoid creating an environment conducive to pest activity?

1. Does the establishment have a nominated person to manage pest control activities and/or deal with appointed expert contractors?

2. Are pest management programs documented, identifying target pests and addressing plans, methods, schedules, control procedures, and training requirements?

3. Do programs include a list of chemicals approved for use in specified areas of the establishment?

1. Are buildings maintained in good repair, and are holes, drains, and other potential pest access points sealed?

2. Are external doors, windows, or ventilation openings designed to minimize the potential for entry of pests?

1. Are storage practices designed to minimize the availability of food and water to pests, and is the material found to be infested handled in a way that prevents contamination of other materials, products, or the establishment?

2. Is potential pest harbourage, such as burrows, undergrowth, and stored items, removed?

3. If outside space is used for storage, are stored items protected from weather or pest damage, such as bird droppings?

1. Do pest-monitoring programs include placing detectors and traps in key locations to identify pest activity, maintaining a map of detectors and traps, and ensuring detectors and traps are of robust, tamper-resistant construction and appropriate for the target pest?

2. Are detectors and traps designed and located so as to prevent potential contamination of materials, products, or facilities?

3. Are detectors and traps inspected at a frequency intended to identify new pest activity, and are the results of inspections analyzed to identify trends?

4. Are the results of the inspections analyzed to identify trends?

1. Are eradication measures put in place immediately after evidence of infestation is reported?

2. Is pesticide use and application restricted to trained operatives and controlled to avoid product safety hazards, with records of pesticide use maintained to show the type, quantity, and concentrations used; where, when, and how applied; and the target pest?

1. Are requirements for personal hygiene and behaviors established and documented, proportionate to the hazard posed to the process area or product?

2. Are all personnel, visitors, and contractors required to comply with the documented requirements for personal hygiene?

1. Are personnel hygiene facilities available to ensure the degree of personal hygiene required by the organization can be maintained?

2. Are the facilities located close to the points where hygiene requirements apply and are clearly designated?

3. Do personnel hygiene facilities include adequate numbers, locations, and means of hygienically washing, drying, and sanitizing hands, along with appropriate toilets, changing facilities, and designated sinks for hand washing?

1. Are staff canteens and designated areas for food storage and consumption situated to minimize the potential for cross-contamination of production areas?

2. Are staff canteens managed to ensure hygienic storage of ingredients and the preparation, storage, and serving of prepared foods, with specified storage conditions and temperatures?

3. Are employees’ own food stored and consumed in designated areas only?

1. Is work clothing worn in areas where exposed products and/or materials are handled fit for purpose, clean, and in good condition?

2. Is clothing mandated for food protection or hygiene purposes and not used for any other purpose?

3. Does workwear not have buttons? Are zips or press stud fastenings acceptable? Does workwear not have outside pockets above waist level and is fully enclosed to ensure adequate coverage and prevent contamination?

4. Is workwear laundered to standards and at intervals suitable for the intended use of the garments?

5. Are hair, beards, and mustaches protected (i.e. completely enclosed) by restraints unless hazard analysis indicates otherwise?

6. Where gloves are used for product contact, are they clean and in good condition? Are the use of latex gloves avoided where possible?

7. Are shoes for use in processing areas fully enclosed and made from non-absorbent materials?

8. Is personal protective equipment, where required, designed to prevent product contamination and maintained in a hygienic condition?

1. Are employees required to undergo a medical examination prior to employment in food contact operations, unless a documented hazard or medical assessment indicates otherwise?

2. Are additional medical examinations, where permitted, carried out at intervals defined by the organization?

1. Are employees required to report specified conditions to management for possible exclusion from food-handling areas, and are those known or suspected to be infected with a disease or illness transmissible through food prevented from handling food?

2. In food-handling areas, are personnel with wounds or burns required to cover them with specified dressings? Is any lost dressing reported to supervision immediately?

3. Are dressings brightly colored and metal detectable where appropriate?

1. Are personnel in food production areas required to wash and, where required, sanitize hands for the following: • before starting any food-handling activities • immediately after using the toilet or blowing the nose • immediately after handling any potentially contaminated material

2. Are personnel required to refrain from sneezing or coughing over materials or products and is spitting prohibited?

3. Are fingernails kept clean and trimmed?

1. Is personal behavior in processing, packing, and storage areas governed by a documented policy that covers the permissibility of smoking, eating, and chewing in designated areas only?

1. Is rework stored, handled, and used in a manner that ensures the maintenance of product safety, quality, traceability, and regulatory compliance?

1. Are stored rework items protected from exposure to microbiological, chemical, or extraneous matter contamination?

2. Are there documented and met segregation requirements for rework, including allergen considerations?

3. Is rework clearly identified and/or labeled to allow traceability, and are traceability records maintained?

4. Is rework classification or the reason for rework designation, recorded (e.g., product name, production date, shift, line of origin, shelf-life)?

1. Are the acceptable quantity, type, and conditions of rework use specified when incorporated into a product as an "in-process" step?

2. Is the process step and method of addition, including any necessary pre-processing stages for rework use, defined?

3. Are controls in place to ensure the removal and segregation of packaging materials when rework activities involve removing a product from filled or wrapped packages, preventing contamination with extraneous matter?

1. Are systems in place to identify, locate, and remove products failing to meet required food safety standards from all necessary points of the supply chain?

1. Is a list of key contacts in the event of a recall maintained?

2. Are product recall procedures evaluated for products withdrawn due to immediate health hazards, ensuring the safety of other products produced under the same conditions?

1. Are materials and products stored in clean, dry, well-ventilated spaces protected from dust, condensation, fumes, odors, or other sources of contamination?

1. Are warehousing temperature, humidity, and other environmental conditions effectively controlled where required by product or storage specifications?

2. Are measures in place to protect lower layers when products are stacked?

3. Are waste materials and chemicals (cleaning products, lubricants, and pesticides) stored separately?

4. Is a separate area or other means of segregating non-conforming materials provided?

5. Are specified stock rotation systems (FIFO/FEFO) observed in warehousing?

6. Are gasoline- or diesel-powered forklift trucks prohibited in food ingredient or product storage areas?

1. Are vehicles, conveyances, and containers maintained in a state of repair, cleanliness, and condition consistent with requirements given in relevant specifications?

2. Do vehicles, conveyances, and containers provide protection against damage or contamination of the product, and is control of temperature and humidity applied and recorded where required?

3. Is cleaning carried out between loads when the same vehicles, conveyances, and containers are used for food and non-food products?

4. Are bulk containers dedicated to food use only, and where required, are they dedicated to a specified material?

1. Is the information presented to consumers in a manner that enables them to understand its importance and make informed choices?

2. Can information be provided by labeling or other means, such as company websites and advertisements, including storage, preparation, and serving instructions applicable to the product?

1. Is each establishment required to assess the hazard to products posed by potential acts of sabotage, vandalism, or terrorism and put in place proportional protective measures?

1. Are potentially sensitive areas within the establishment identified, mapped, and subject to access control?

2. Where feasible, is access physically restricted by the use of locks, electronic card keys, or alternative systems?

3. In addition to ISO/TS 22002-1:2009 clause 9.2, does the organization have a policy for the procurement of animals, fish, and seafood that are subject to control of prohibited substances? (e.g. pharmaceuticals, veterinary medicines, heavy metals, and pesticides)

1. n addition to clause 8.5.1.3 of ISO 22000:2018, does the organization ensure that finished products are labeled according to all applicable statutory and regulatory requirements in the country of intended sale, including allergen and customer-specific requirements?

2. Where a product is unlabelled, is all relevant product information made available to ensure the safe use of the food by the customer or consumer?

1. Does the organization have a documented procedure in place to: • Conduct a threat assessment to identify and assess potential threats • Develop and implement mitigation measures for significant threats

1. Does the organization have a documented food defense plan specifying the mitigation measures covering the processes and products within the FSMS scope of the organization?

2. Is the food defense plan supported by the organization’s FSMS?

3. Does the plan comply with applicable legislation and be kept up-to-date?

1. Does the organization have a documented procedure in place to: • Conduct a food fraud vulnerability assessment to identify and assess potential vulnerabilities • Develop and implement mitigation measures for significant vulnerabilities

1. Does the organization have a documented food fraud mitigation plan specifying the mitigation measures covering the processes and products within the FSMS scope of the organization?

2. Is the food mitigation plan supported by the organization’s FSMS?

3. Does the plan comply with applicable legislation and be kept up-to-date?