GMP Inspection Checklist

Use this GMP Inspection Checklist to conduct an internal audit of your procedures, to ensure compliance with HACCP and GMP standards.

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Food & Hospitality
GMP Inspection Checklist

Management Commitment

1. Does senior management demonstrate commitment to safe food production and handling through: • Promoting food safety awareness throughout the organization? • Facilitating communication relating to food safety issues and incidents? • Providing adequate resources to fully implement the HACCP system to achieve compliance with the BSI HACCP & GMP Certification Criteria?

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Continual Improvement

1. Has the effectiveness and continual improvement of the HACCP system been demonstrated through the review of internal verification activities, non-conforming product actions, corrective actions, and the results of external audits? New scientific developments, advances in technology, and industry best practices should also be considered.

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Food Safety Policy

1. Will the organization develop a policy that states the organization’s commitment and measurable objectives for the supply of safe and suitable food products that meet customer expectations and legal requirements in the country of manufacture and the country of sale? Will a program to measure and improve food safety culture be established and maintained?

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Roles, Responsibilities And Authorities

Controls For Documented Information

1. Has a system to manage documented information (electronic and hardcopy) been implemented to ensure the currency of documentation in use and provide a system for records to be retained and readily retrieved? Documentation and record keeping should be appropriate to the nature and size of the organization and sufficient to verify that the HACCP controls are in place and being maintained. This may include, but is not limited to: • The responsibilities for the development, maintenance, and authorization of all documentation within the HACCP system • Methods of ensuring obsolete documents are removed from use • Responsibilities for the communication of changes to documentation within the HACCP food safety system • Methods for ensuring the security of the documented HACCP food safety system • The method of destruction and control of customer-owned/branded/trademarked documentation, product, and packaging

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Document Register

1. Has a document register (list) of the documents referenced in the HACCP system been developed? This may include, but is not limited to the following: • HACCP team composition • Product description and intended use • Hazard analysis, including risk assessment and associated scientific references • CCP determination • Critical limit validation • HACCP audit table • Specifications (raw materials and finished product) • Formulations (recipes) • Prerequisite programmes • Standard operating procedures and work instructions • Policies • Forms

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2. Does the organization have access to, and control of, external documents or references required to maintain the HACCP system? This may include but is not limited to food safety statutory and regulatory requirements, codes of practice, guidelines, and standards appropriate to the country in which the food products are manufactured and sold.

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HACCP System

The HACCP Team

Scope And Purpose Of The HACCP Plan

2. Will the purpose of the HACCP system include the intent that all food safety hazards will be identified and controlled? Food safety hazards may include but are not limited to: biological, chemical, physical (foreign matter), allergen, and radiological hazards as appropriate to the products in the scope of the HACCP plan.

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Product Description And Intended Use

2. Are ‘Like’ products that are processed in similar ways grouped together in one product description? Are products that are processed using different food safety controls, processing techniques or packaging methods have a separate product description?

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3. A product description for each product or group of products shall detail the following information: Composition (e.g. formulation/ingredients) Physical and chemical characteristics (e.g. final product aW, pH, addition of preservatives) Production methods and technologies (e.g. heat treatment, high-pressure processing (HPP), freezing, drying, brining, etc.) Primary and secondary packaging (e.g. type of packaging used, durability, functional effect on food safety such as the extension of shelf life, etc.) Storage, handling, and distribution methods (e.g. refrigerated/ambient transport requirements) Shelf life (including best-before or use-by-date coding) Intended use of the product(s) Labeling requirements including any claims as per local legislation in the country of sale Allergens as per local legislation in the country of sale Sensitive consumers Some or all of this information may be contained within finished product specifications.

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Process Flow Diagram

1. Is a process flow diagram documented for each product or group of products? Is every step in the process(es) identified and sufficiently detailed to include the sequence and interaction of steps, inputs, outsourced processes, intermediate products, rework, end products, waste, and by-products relevant to the process? Complex manufacturing operations may be broken into a series of linked flow diagrams to provide a clear and accurate representation of the process flow.

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Hazard Analysis And Control Measures

1. Will a hazard analysis be undertaken and documented for each step of the process and process inputs as identified in the flow process? Will the HACCP team reference the verified process flow diagram in the hazard analysis to identify all potential food safety hazards (as identified in the purpose of the HACCP plan) which need to be prevented, eliminated, or reduced to accepted levels?

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3. Are identification and assessment of hazards ungrouped? (e.g. foreign matter which shall be separated into wood splinters, packaging materials, hair, etc.). Is the identification of potential hazards also taken into consideration of the hazards reported in food recalls and outbreaks of foodborne illness as appropriate to the product, process, and global supply chains?

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5. Will hazards that are reasonably likely to occur in the absence of control and reasonably likely to cause illness or injury if present be identified and controlled by measures designed to prevent or eliminate these hazards or reduce them to an acceptable level?

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7. When determining significant hazards, does the HACCP team consider the following as applicable to the product and process? • Hazards known to be associated with the type of food, ingredients used in the product, and process steps • Likelihood of occurrence of hazards, taking into consideration prerequisite programs, in the absence of additional control •Likelihood and severity of adverse health effects associated with the hazards in the food in the absence of control • Identified acceptable levels of the hazards in the food (e.g. permissible additives and maximum residue limits defined by regulations in the country of sale) • The food-handling environment and equipment used to produce the food product • The likelihood of survival and/or growth of pathogenic microorganisms • The potential for the presence of toxins (e.g. mycotoxins), chemicals (e.g. pesticides, drug residues), or foreign matter (e.g. glass, metal, soft plastic) • The intended use and/or probability of the product being mishandled by potential consumers that may cause the food to become unsafe Guidance note: There is no specific methodology required to be used to determine the significance of hazards.

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8. For all hazards determined to be significant, is there at least one control measure designed to prevent or eliminate the hazard, or reduce the hazard to an acceptable level? Control measures may reference the application of a pre-requisite program to reduce, prevent or eliminate a significant hazard (e.g. cleaning of equipment to prevent cross-contact of food allergens from one food to another food that does not contain that allergen). In other instances, the control measures shall be applied within the process at critical control points (CCPs).

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Critical Control Points

1. Will the HACCP team determine the critical control points for hazards identified in the hazard analysis as significant hazards? Will CCPs be established at steps where control is essential to safe food production and where a deviation could result in potentially unsafe food? There may be more than one CCP in a process in which control is applied to address the same hazard. If no control measures exist at any step for an identified significant hazard, then is the product or pro- cess modified? Guidance note: There is no specific methodology required to be used to determine CCPs.

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HACCP Audit Table

1. Will a HACCP audit table be developed, documented, and applied which includes all steps of the process where CCPs have been identified? Will the corresponding monitoring activities, corrective actions in the case of deviations, and verification activities be documented for each CCP?

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Validated Critical Limits

2. Are critical limits measurable or observable? There may be multiple critical limits identified for a CCP, (e.g. heat treatments may include critical limits for time at temperature). Are critical limits for control measures at each CCP specified and scientifically validated to obtain evidence that they are capable of controlling hazards to an acceptable level if properly implemented? Guidance note: Critical limit criteria may include minimum and/or maximum values (e.g. temperature, time, pH, available chlorine, contact time, conveyor belt speed, flow rate, etc.).

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3. Is validation of critical limits considered if the appropriate critical limit has been determined and the capability of the organization to consistently achieve the limit(s)? Validation data shall be documented. Guidance note: validation data may include, but is not limited to: regulations, industry codes of practice, guidance from competent authorities, studies conducted by equipment manufacturers, and site-specific information confirming their capability to consistently achieve the critical limit(s).

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System To Monitor Control Of CCPs

3. Will the monitoring procedures for CCPs be capable of timely detection of a deviation from the critical limit to allow non-conforming products to be isolated? The monitoring of CCPs should be continuous, where possible. If monitoring is not continuous, then is the frequency of monitoring sufficient to ensure that the CCP is under control? (e.g. critical limits based on observation such as the application of the correct label to a product containing allergens, needs a monitoring frequency based on the capability of the organization to prevent the distribution of non-conforming products). Guidance note: physical and chemical measurements are usually preferred to microbiological testing because physical and chemical tests can be done rapidly and can often indicate the control of microbial hazards associated with the product and/or the process.

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CCP Corrective Actions

1. Are specific written corrective actions developed for each CCP in the event that critical limits are not achieved to prevent the release of potentially unsafe food? Will actions be taken to segregate the affected product and assess the safety of the food product to ensure the appropriate disposition?

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Validation Of The HACCP Plan And Procedures For Verification - Verification Procedures

1. Will validation of the entire HACCP plan be completed prior to implementation to ensure the elements of the HACCP plan are capable of ensuring control of the significant hazards? This includes validation of the identified hazards, critical control points, critical limits, control measures, frequency and type of monitoring of CCPs, corrective actions, frequency and type of verification and the type of information to be recorded. Guidance note: validation of control measures and their critical limits is completed during the development of the HACCP plan. Validation may include a review of scientific literature, in-house validation studies, and/or using guidancedeveloped by external authorities.

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2. Will verification procedures be established to confirm that the HACCP system is working effectively? Do these include procedures to verify that the HACCP plan is being followed, that the HACCP system is able to control hazards on an ongoing basis, and show that the control measures are effective to control the hazards as intended?

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Validation Of The HACCP Plan And Procedures For Verification - HACCP System Review

1. Will verification activities be completed on a planned, ongoing basis to ensure that the HACCP system remains capable of safe food production? Verification activities may include but are not limited to: • Review of monitoring records to confirm that CCPs are under control • Review of corrective action records, including specific deviations, product disposition, and root cause to determine the cause(s) of the deviation • Calibration or confirmation of the accuracy of instruments used for monitoring and/or verification activities • Observation to confirm control measures are conducted in accordance with the HACCP plan • Product sampling and analysis (e.g. microbiological hazards such as pathogen testing, chemical hazards such as mycotoxins, or physical/foreign matter hazards such as metal fragments), to verify product safety • Environmental monitoring (e.g. Listeria and/or Salmonella) • Review of the HACCP system, including the hazard analysis and the HACCP plan (e.g. internal and/or third-party audits)

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2. Will verification include a comprehensive review of the HACCP system annually or when changes occur, to confirm the efficacy of all elements of the HACCP system? The review of the HACCP system shall confirm the following: • Appropriate significant hazards have been identified • Control measures and critical limits are adequate to control the hazards • Monitoring and verification activities occur as planned and are capable of identifying deviations • Corrective actions are appropriate for deviations that have occurred Guidance note: this review can be carried out by individuals within a food business or by external experts.

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5. Will the organization monitor the pre-requisite programs and control measures applied to control hazards? Do procedures include a description of the monitoring methods, responsible personnel, frequency and sampling (as applicable), and monitoring records to be kept? Is the frequency of monitoring appropriate to ensure consistent process control?

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6. Will the organization undertake verification activities to confirm that GMP procedures have been effectively implemented and that monitoring is occurring as planned and appropriate corrective actions are taken when requirements are not met? Examples of verification activities may include but are not limited to the following: • Review of GMP procedures, monitoring, corrective actions, and records • Review when any changes occur to the product, process, and other operations associated with the organization • Validation of the cleaning program to meet the required cleaning standards • Records of GMP verification activities shall be retained

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Validation Of The HACCP Plan And Procedures For Verification - Microbiological And Chemical Testing

Validation Of The HACCP Plan And Procedures For Verification - Shelf-life Testing

1. Will new and re-developed products with a shelf life of less than two (2) years, have a schedule of shelf-life testing documented and implemented? Will the shelf-life testing schedule include the type of testing to be undertaken and shall be carried out after the expiry date of the product? (i.e. not on the date of expiry)? Considerations for shelf-life testing may include, but are not limited to the following: • Where the product can be frozen, as part of the storage instructions, the end-of-shelf-life testing shall be carried out after the end of the frozen period has been reached • Shelf-life tests may include chemical, microbiological, organoleptic, and physical testing (e.g. weight loss during storage) • Where shelf-life limits are being established for new products, the process for determining the shelf life and any assumptions shall be clearly documented • End-of-shelf-life testing results shall demonstrate that the parameters of the product at the end of shelf life continue to meet the finished product specification. If this is not met, corrective action shall be taken

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Validation Of The HACCP Plan And Procedures For Verification - Finished Product Assessments

Validation Of The HACCP Plan And Procedures For Verification - Monitoring And Corrective Actions Of Verification Activities

Validation Of The HACCP Plan And Procedures For Verification - Customer Complaints

Establish HACCP Plan Documentation

1. Is a system of record-keeping relevant to the HACCP system documented and implemented? Are all records associated with the HACCP system retained including: • Monitoring of CCPs • Corrective actions taken regarding CCPs • Changes to the HACCP system • Pre-requisite programmes • Procedures for verification • Validation of critical limits

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Personal Hygiene

1. Will a personal hygiene policy and procedure be developed, documented, and implemented? As a minimum, will the following elements be included: Personnel illness and injury (it may be appropriate for personnel to be excluded for a specific time after symptoms resolve or to obtain medical clearance before returning to work): • Eating, drinking, smoking and vaping restrictions • Hand-washing requirements • Hygienic behaviours when sneezing, coughing and blowing of nose • Protection of cuts and wounds and bandage requirements • Clothing and Personal Protective Equipment (PPE) requirements • Jewellery restrictions (including watches and piercings) • Control of personal items including medication and mobile phones • False nails (including acrylics) and false eyelashes • Personnel movement restrictions • Control of visitors and contractors • Procedures to ensure the storage of protective clothing worn in areas of different hygiene risks is not contaminated • Protocols for returning to work after breaks • Use of signs in the language spoken by employees, located in prominent and sensible locations and made of suitable materials to prevent the risk of product contamination

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Cleaning

1. Will the organization develop, document, implement and maintain a cleaning program to remove food residues that may be a source of contamination, including allergens? Will cleaning be carried out using wet or dry cleaning methods, (e.g. heat, scrubbing, turbulent flow, vacuum) and chemical methods using solutions of detergents, alkalis, or acids? Will cleaning methods and materials be appropriate to the food type and the surface to be cleaned? The program shall identify the following (where appropriate): • Areas within and outside the building that require cleaning • Equipment that requires cleaning (including cleaning equipment and waste) • Between batch cleaning • Method of cleaning and, where required, sanitation (disinfection) • Frequency of cleaning • Chemicals used, if applicable (all cleaning chemicals shall be approved for use within a food production facility) • Chemical concentrations, contact time and temperature • Persons responsible for cleaning • Records of the monitoring of cleaning • Appropriate training for cleaning personnel

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2. Will the cleaning program state how monitoring of cleaning is undertaken, the frequency of monitoring, and corrective action to be taken if monitoring reveals that the cleaning is not effective? Guidance note: Microorganisms may become tolerant to sanitizing (disinfecting) agents over time. A periodic review with the organization’s chemical supplier(s) should be completed to ensure the sanitizer(s) (disinfectant(s)) used are effective to ensure the inactivation of different types of microorganisms (e.g. bacteria and fungi).

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4. Is environmental monitoring (e.g. protein and allergen test swabs or microbiological testing for indicator organisms) to validate the effectiveness of the cleaning program undertaken commensurate with product and process risk? Are records of sampling locations, methodology, corrective actions, and retests of sampling locations maintained?

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Approved Supplier Programme

2. Will the approved supplier program include criteria for: • Selecting and approving suppliers and service providers • Emergency suppliers/providers • Removing suppliers/providers • Records of approval may include evidence of regulatory compliance, certificates of food safety certification, supplier questionnaires and other formal agreements

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3. Will the method of monitoring incoming products and services be documented and implemented and records maintained? Do methods of monitoring include but are not limited to: • Visual inspection to check for packages damaged during transportation, sufficient use-by-date or best-before-date, contamination with foreign matter or allergens during transit, and correct temperature for refrigerated and frozen foods • Receipt of a Certificate of Analysis or other details of compliance to specification • Reconciliation of purchasing documentation for supplier details, date of receipt, and quantity • Incoming materials that do not meet food safety criteria should not be accepted by the organization

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Specifications

Labelling

1. Will the organization ensure there is a process for the preparation and review of labels which includes: • Confirmation that the information on the label complies with food safety regulations and other applicable regulations that may apply to specific industry sectors in the country of sale • Confirmation that clear instructions have been provided to enable the next person in the food chain to handle, display, store, and use the product safely • Review of label information in the event of the following: 1. Changes in labeling laws and regulations 2. Changes in raw materials and recipes including the introduction of ingredients that contain allergens applicable in the country of sale 3. Changes in processing that may impact the food safety of the finished product (e.g. change from pasteurization to high-pressure processing) • The label shall be checked prior to production commencing to confirm the correct label, correct date coding for use by/best before date, and legibility.

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Allergen Management Program

1. Is an allergen management program documented and implemented to ensure the effective management of allergenic materials to prevent contamination and cross-contact? This program shall include but is not limited to: • A documented risk assessment of ingredients containing allergens (this may form part of the raw material food safety risk assessment) • Receipt and storage practices for ingredients containing allergens • A list of all allergenic ingredients on site • Control measures to prevent contamination and cross contact of allergens in products that do not contain the allergen • Scheduling of production to prevent contamination and cross contact of allergens through shared equipment and processing areas • Policies relating to the use of allergenic ingredients in rework • Consideration of allergens during product development • Mandatory declaration of allergens on product labels as required in the country of sale • Allergen ‘free from’ claims shall be validated and reviewed on an annual basis • Validation and verification procedures for cleaning and maintenance programmes

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Packaging

Control Of Non-conforming Product

Traceability

1. Will the organization have a documented procedure that ensures, for all stages of production from receival through to finished goods, products are clearly identified? Will this include (where applicable): • Raw material receival • Storage • Work in progress • Rework • Final product • On hold product • Reject product, quarantined/nonconforming product • Returned product, downgraded/damaged stock • Food waste designated to animal feed • Waste product(s) • Cleaning chemicals and • Packaging • New product development materials

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Corrective Action

Recall

2. Will the annual review include a test of the traceability process on at least an annual basis? Will this be performed as a component of the mock recall and will include a test of the forward and backward traceability? (this makes up part of the product traceability exercise referred to in clause 3.9 of this Criteria document).

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Design Of Facilities And Equipment - Facility Requirements

Design Of Facilities And Equipment - External Areas

Design Of Facilities And Equipment - Layout, Product Flow And Segregation

2. Will food handling areas that have different levels of hygiene control (e.g. low-risk vs. high-risk areas) shall have appropriate segregation to minimize cross-contamination? Will segregation include walls, partitions, and/or allocation of areas within an open production area and separation in time as appropriate to product and process risks?

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Design Of Facilities And Equipment - Building Fabric And Equipment

1. Will the fabrication of the buildings be suitable for the intended purpose and constructed of durable materials that are able to be maintained, effectively cleaned, and where appropriate, sanitized? (disinfected) Will building materials be constructed of non-toxic materials according to the intended use and normal operating conditions?

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3. Will floors be impervious to moisture, maintained in good condition, and easy to clean and maintained clean? Where required, will floors be graded to drains to prevent pooling? Where required for wet cleaning operations, will coving between the floor and wall be used to facilitate cleaning?

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8. Doors into production areas shall be close-fitting to prevent pest and dust ingress. Doors (including rapid roller doors) shall be kept closed at all times when not in use. Doors that operate as an airlock should not allow for both doors to be open at the same time as this would compromise airlock controls intended to minimize contamination.

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Design Of Facilities And Equipment - Employee Amenities

1. Will employee amenities be suitably located and include as required, designated areas for employees to keep personal belongings, changerooms, toilets, hand-washing and drying facilities as well as areas for eating, drinking, and smoking? These facilities shall not be used for other purposes such as storage of food or items that contact food.

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Receival And Storage

1. Will procedures for the safe and suitable storage of products be implemented? Will these procedures include reference to allergen management, cleaning, stock/ inventory control, segregation of non-conforming products, and handling to minimize stock damage and cross-contamination?

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Dispatch And Transport

3. Will procedures be documented and implemented for the breakdown of transport vehicles used to transport food products requiring temperature, humidity, atmosphere, and other conditions necessary to protect food from microbial growth and deterioration?

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Control Of Water, Ice, Air And Other Gases

Control Of Foreign Materials

1. Will controls for foreign materials in food handling areas (e.g. glass, metal, hard and soft plastics, wood splinters, jewelry) shall include suitable prevention strategies including preventative maintenance and regular inspection of equipment? Will procedures for the control of foreign materials be documented, with appropriate records of compliance to procedures retained?

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Control Of Chemicals

Maintenance

4. Will maintenance employees and contractors take measures to ensure all tools are suitable for food production areas and that measures are in place to ensure tools and maintenance debris is removed when maintenance activities are completed? This is critical for intrusive maintenance activities where maintenance tools and debris will not be visible to production employees following maintenance activities.

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Calibration

Training

1. Will a food safety training program be implemented to ensure personnel handling food have the necessary knowledge and skills? Will the training program consider the food safety knowledge required for the product and process risks including: • Type of food safety hazards known to be associated with the food products handled by the site (e.g. growth of pathogenic or spoilage microorganisms, foreign matter containments, allergens) • The production and packing processes used by the organization

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Waste Management

Pest Management

4. Will the program also include: • Bait maps depicting the type and location of treatments • Bait stations shall be secured against movement and tampering • Records of the chemicals used and the concentration • Where required by local regulations, current information for pest control chemicals used or stored on site • If pest control chemicals are stored on-site, these shall be stored in a separate area away from food handling areas and chemicals used for production or maintenance purposes • Where an external pest control contractor is used, evidence of their competency to perform pest inspection and treatment activities shall be maintained • Where pest control activities are carried out by internal personnel, these personnel shall be suitably trained and records of training retained

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GMP Inspection Checklist

Use this GMP Inspection Checklist to conduct an internal audit of your procedures, to ensure compliance with HACCP and GMP standards.

2. Shall senior management provide appropriate and trained resources to ensure the safety and suitability of the food products covered under the scope of certification?

1. Are roles, responsibilities, and authorities with an impact on food safety clearly communicated in the organization?

2. Are position descriptions or equivalent, available for all positions that have a responsibility for food safety and maintenance of the HACCP system?

1. Will the organization develop, document, and implement a HACCP system based on the Codex Alimentarius General Principles of Food Hygiene?

1. Will the organization identify and document the members of the HACCP team?

2. Will the HACCP team comprise those within the organization who have the skills and knowledge to develop and maintain the HACCP plan? It is preferable to have a multi-functional HACCP team.

3. Where a consultant has been engaged by the organization to assist in the development and ongoing maintenance of the HACCP system, will the organization ensure that the consultant holds appropriate qualifications?

4. Will the organization demonstrate they are responsible for the day-to-day management of the HACCP system?

1. Will the scope of the HACCP plan be defined and documented to define the start and end point of the process(es) under consideration and the products covered in the HACCP system?

1. Will a product description be developed and documented for all products included within the scope of the HACCP system?

2. Are ‘Like’ products that are processed in similar ways grouped together in one product description? Are products that are processed using different food safety controls, processing techniques or packaging methods have a separate product description?

2. Once developed, will the HACCP team verify the accuracy of the flow diagram through a physical walk-through of the process at least annually, or when there are significant changes to the product or process?

3. Will records of this verification activity be kept?

2. Will both the hazard and the cause of the hazard be documented?

4. Does the HACCP team evaluate the hazards to identify the hazards that are essential to prevent, eliminate or reduce to acceptable levels for the production of safe food? (i.e. identify significant hazards).

5. Will hazards that are reasonably likely to occur in the absence of control and reasonably likely to cause illness or injury if present be identified and controlled by measures designed to prevent or eliminate these hazards or reduce them to an acceptable level?

6. Where the organization has included quality hazards in the HACCP plan, are these identified in the risk assessment? These hazards shall be considered separately from the food safety hazards.

1. Will a HACCP audit table be developed, documented, and applied which includes all steps of the process where CCPs have been identified? Will the corresponding monitoring activities, corrective actions in the case of deviations, and verification activities be documented for each CCP?

1. Will validated critical limits be determined for each CCP to separate acceptable products from unacceptable products?

1. Is a monitoring system for each CCP established? Guidance note: monitoring of CCPs is the scheduled measurement or observation at a CCP relative to its critical limits.

2. Do monitoring procedures define what is being monitored, how the monitoring is carried out, the frequency of monitoring, where the monitoring is to take place, and who is responsible for undertaking the monitoring?

4. Does the organization also ensure that personnel who conduct monitoring checks are trained in the correct method and that training for CCP monitoring activities is assessed and documented?

5. Are records of CCP monitoring maintained to demonstrate a history of compliance to critical limits?

6. Are all CCP records signed or initiated by the person performing the monitoring and reports the results and timing of the monitoring activity?

2. Will the procedures state what action is to be taken regarding the affected product, who is responsible, and what action is to be taken regarding the process?

3. Will a root cause analysis be conducted to identify and correct the cause(s) of the deviation to prevent recurrence?

3. Will records be maintained for HACCP system reviews?

4. Will verification be carried out by a person other than the individual(s) responsible for performing the monitoring and corrective actions? Verification activities may be performed by external experts or qualified third parties.

1. Are the sampling methodology and test limits documented and include the corrective actions for test results that are outside the limits?

2. Is testing conducted by suitably trained personnel or by an external laboratory that holds laboratory accreditation for the tests being completed?

3. Will the results of the tests be reviewed by a trained and responsible person within the organization and within an appropriate timeframe with respect to the purpose of the test (e.g. product clearance to release product on hold).

4. Will corrective action be taken when results indicate that limits have been exceeded? Will appropriate actions be taken to identify and isolate the product as per clause 3.8 Control of Non-Conforming Product?

5. Will records of test results and corrective actions be kept?

1. Will a schedule of finished product assessments against the finished product specifications including organoleptic, biological, chemical, and physical parameters be developed, documented, and implemented?

2. Will the results of finished product assessments be reviewed by a suitably trained and knowledgeable person within the organization to identify the need for changes to the HACCP system? Will records of the results be maintained?

1. Will the organization review the results from HACCP verification activities to ensure that the HACCP system is under control?

2. Will the scheduled verification/review processes be documented to include the monitoring of corrective actions taken to address findings from verification activities?

1. Will customer complaints relating to food safety issues be recorded and managed by suitably trained personnel to ensure adequate investigation and consideration of the issue in the context of the HACCP system?

2. Will records be retained for a minimum of 12 months, or the shelf life of the subject product(s), whichever is greater?

3. Will hardcopy and electronic records be protected from damage or loss, and will be easily accessible and securely stored?

3. Will the condition of cleaning utensils and equipment be assessed regularly to ensure any worn equipment or utensils do not pose a risk of cross-contamination to the production process?

5. Where required, do clean-in-place (CIP) systems have procedures documented and implemented to ensure there are no residual cleaning chemicals in products?

6. Does validation of the CIP system be completed to ensure that the system is capable of removing soiling and preventing contamination of food products? Is the frequency of validation based on product and process risk?

7. Will housekeeping and cleaning standards be maintained in all areas to prevent environmental contamination?

1. Will an approved supplier program be documented and implemented for products and services (ingredients, packaging, chemicals, outsourced processes, and third-party contractors) that may affect the food safety or quality of the finished product?

1. Will documented specifications be available for all raw materials (including packaging) and finished products to ensure compliance with relevant food safety and legislative requirements for food products handled by the site?

2. Will records of labeling reviews be maintained?

2. Will employees and contractors train in the allergen management program?

3. Is compliance with the site allergen management program maintained in all areas of operation?

1. Will all packaging be fit for purpose taking into consideration the product characteristics and handling in the supply chain?

2. Will the packaging be protected from contamination when in storage? Will the packaging be stored in a designated area separate from food ingredients, finished products, and non-food chemicals? (including cleaning materials, lubricants).

1. Will controls for non-conforming products be developed, documented, and implemented? As a minimum, will non-conforming products be segregated and identified to prevent accidental release or use?

2. Will the procedures state what action is to be taken regarding the affected product, who has responsibility for the action, the need for root cause analysis, and what actions should be taken to prevent recurrence?

3. Will records of non-conforming products for raw materials and through all stages of the process including rework be maintained to ensure full traceability? Will records include product hold, corrective actions, and disposal?

2. Will the procedure document how the product is traced to the customer (one forward) and back to the supplier? (one back).

3. Will records of traceability be maintained?

1. Will the organization demonstrate that they are able to use information from identified failures in the HACCP system to identify the root cause, make necessary corrections, and prevent re-occurrence?

1. Will the organization have a documented recall procedure in place that complies with the requirements of the local legislation in the country of sale?

3. Will clear and accurate records of the recalls, withdrawals, and mock recalls be maintained?

1. Will the facility design and construction be suitable for the type of food products handled at the site?

2. Will the facility be of an appropriate size and layout to reduce the risk of contamination and ensure the production of safe and legal food products?

3. Will a process for monitoring the condition of the facility be implemented? Will the frequency of monitoring processes be determined based on the risk documented? Will records of monitoring activities be retained?

1. Will the external areas around the facility be maintained in a clean condition with no overgrown vegetation that could compromise preventative pest controls?

2. Will smokers waste be controlled to prevent potential contamination of food products stored and handled by the facility?

1. Will the layout of premises and the flow of operations, including the movement of personnel, raw materials, utensils, packaging rework, and/or waste not compromise the food safety of products?

2. Will walls be impervious to moisture, maintained in good condition, and easy to clean and maintain cleanliness?

3. Will floors be impervious to moisture, maintained in good condition, and easy to clean and maintained clean? Where required, will floors be graded to drains to prevent pooling? Where required for wet cleaning operations, will coving between the floor and wall be used to facilitate cleaning?

4. Will drains be maintained in good condition and easy to clean and maintained clean? Will drain grates and basket traps be removable to allow for ease of cleaning?

5. In facilities where there is segregation between areas of different hygiene controls (e.g. low and high-risk areas), will wastewater not drain from low-risk to high-risk areas?

6. Will ceilings (including false ceilings) be smooth, impervious to moisture, easy to clean and maintained clean, and not allow for the entry of pest or dust ingress?

7. Will windows located in production areas with open and exposed products be kept closed or have adequate pest-proofing or screens?

9. Will light fittings be protected to ensure food is not contaminated by breakage? Will the replacement of light fittings above open product areas be scheduled to occur when production is not in process?

10. Will glass windows be protected to prevent glass contamination in the event of a breakage?

11. Will equipment used for thermal processes or to chill/freeze food be designed to achieve the process requirements to ensure food safety and suitability? Where necessary, will equipment also be designed to allow for temperature monitoring?

12. Will equipment used in food processes be industry standard and maintained in a suitable condition?

2. Will hand-washing stations be located in appropriate locations throughout the site, made of suitable materials and in good condition, and have a supply of warm, running, potable water, with liquid soap and a suitable method of drying hands?

3. Will hand-washing facilities be of an appropriate hygienic design and would have hands-free taps? Where this is not possible, are appropriate measures set to minimize contamination from taps in place?

4. Where personal protective clothing and footwear are required for employees, contractors, and visitors, will there be suitable provisions provided? (e.g. this may require multiple sizes of protective clothing and footwear to be maintained).