Title Page

  • Site Location
  • Site Name

  • Audit Carried Out By

  • Conducted on

  • Scoring: For New Suppliers, the site will be graded as to their overall suitability to manufacture M&S products based on the auditor’s interpretation of the findings.

  • Answers stating 'Compliant' Indicate no actions are required. Answers stating 'Actions Raised - Suitable to Supply' mean the site is suitable to supply M&S but has short-term or long-term findings raised which will need closing out in a stated time frame in the notes.

  • Answers stating Unacceptable = Not suitable to supply M&S – A critical food safety/integrity issue or several areas requiring substantial improvement/change. Re-audit required to formally verify suitable standards achieved before production can commence.

  • In an M&S New Supplier Audit, all short-term actions must be closed off by the site and approved by the 3rd party audit body before first production. Long term actions will be completed up to 6 months later, in time to show evidence of compliance by the next audit.

Leadership and Management (Learning and Development)

  • The site must have a documented and effective learning and development programme in place to ensure that all employees, including agency, are fully trained and competent to carry out their role. The programme must cover: o Induction to provide details about the company, products and hazards o Food Safety qualifications o All procedures and Critical Control Points (CCP’s) in the food production process o Practical guidance / training for Specific product risks e.g., microbiological, foreign matter and allergens, and the role of personnel in preventing product contamination. o Specific requirements for the prevention of cross contamination e.g., low risk/high care segregation. o Customer complaint performance o Requirements of the factory food safety management systems e.g., HACCP, work instructions and procedures (e.g., for cleaning, metal detection, equipment testing), quality systems o The site Personal Hygiene policy

  • Before commencing work in the factory, all employees, including agency workers, must be taken through an Induction program

  • All employees (including agency) must pass Level 2 Food Safety training (or equivalent) within 12 weeks of starting work. Delegates must be individually assessed on their understanding of the course content.

  • As a minimum, roles relating to Critical Control Points and product key quality attributes must be filled with trained workers which have been assessed as competent to carry out the task. CCP training is refreshed annually.

  • Additional training must be implemented for staff working in High Care (HC) or High-Risk (HR) areas, including all HC/HR procedures such as barrier control, i.e., the importance of preventing cross contamination of the HC/HR area, etc.

Food safety management & HACCP

  • The site must be able to explain and demonstrate the measurement and control of food safety parameters for all products manufactured. This must include what processes and intrinsic properties make their products safe during production and throughout their shelf life. The two distinct areas that should be explored and understood in terms of microbiological risk are survival and growth. Different hurdles will be needed depending on which of these you are trying to prevent. E.G. What are the risks identified in the HACCP plan that need mitigation, chemical, physical, microbial etc. Swabbing, PPE etc.

  • The HACCP flow diagrams must be accurate and capture all process steps, and include all inputs/outputs from raw materials to the point of handover to M&S. This must include work in-progress, rework (where permitted), waste, and offline operations. Where storage and distribution activities are contracted to non-M&S third parties, these activities must be included in the HACCP study.

  • Critical Control Points (CCPs) must be validated according to the worst-case scenario by conducting a scientific or detailed study based on product and processing variables. e.g., cooking validations with worst case parameters.

Food Safety Prerequisites

  • Factory Buildings and Equipment • The design and construction of the factory and equipment must be appropriate to the specific manufacturing operation, must support high standards of good manufacturing and engineering practices (GMP) and must protect against food safety hazards. • The process flow must deliver segregation between areas that have a clear difference in microbiological loading i.e., raw proteins and cooked proteins. This must include the segregation of people, raw material/ingredients and finished product. • Equipment must be hygienically designed to allow for effective dismantling and cleaning and be sited to prevent the risk of cross contamination from product, people, and the factory environment. • Where appropriate, there must be sufficient temperature-controlled handling and storage facilities subject to continuous temperature recording and suitably alarmed to allow management intervention at any time of the day. • Ventilation and air handling systems must be installed that are appropriate to the factory environment. • Drains must be adequate for the volume of water and be laid to flow from clean to dirty areas. They must be managed to prevent contamination of clean areas at all times. • An appropriate number of non-hand touch hand wash facilities must be in place at entrances and key areas of production.

  • Engineering and Maintenance • There must be a robust and documented planned preventative maintenance system (PPM) in place that delivers good equipment maintenance in order to limit wear and tear and to effectively manage factory fabrication to prevent foreign body or microbiological risks. • Procedures must be in place to ensure engineering working practices and facilities do not introduce microbiological, chemical, or foreign body risks. These procedures must include food safety risk assessments for reactive or high-risk work being done during production, and a documented procedure for hand back between Engineering, Hygiene/Technical, and Operations to positively release the environment back to Operations after Engineering work. • Temporary engineering solutions (e.g., fixes using tape, wire or tack welds) must not be used. Instead, repairs and fixes must be made quickly and to a high standard, so they do not pose a foreign body risk.

Cleaning and disinfection

  • Cleaning • An effective housekeeping and “Clean as You Go” policy must be implemented for the internal and external areas of the factory. • The site must demonstrate they consistently clean their factory to a good standard of hygiene. • Sites must have the knowledge, tools and capability to dismantle their equipment as much as necessary to enable good standards of hygiene throughout their site. • In–process hygiene must be managed to prevent cross contamination risks to equipment and product.

  • Equipment Washing Areas • Facilities for cleaning production equipment must be appropriately located, of suitable construction and easily cleanable. Drainage must be effective and extraction sufficient to remove steam and prevent excessive condensation. • There must be a logical flow to a washroom so that it is easy to identify clean and dirty equipment, and whether it is ready for use or in need of cleaning. • Where manual cleaning is carried out, suitable racks, tables or frames must be provided to prevent equipment being washed directly on the floor. • Manual cleaning must follow a 3-sink system with gross debris being removed before being put in sink 1. o Detergent o Rinse o Disinfectant. o It is most hygienic for items to then air dry

  • Cleaning Management Systems • The site must demonstrate that it fully implements an effective cleaning management system which includes: o a documented schedule for all internal and external cleaning tasks across the site o detailed and validated Cleaning Instruction Cards (CIC) for each cleaning task o Hygiene team sign-off sheets per piece of equipment/area o daily records of cleaning verification checks of factory environments and associated production equipment. o Hygiene operative training records for each relevant CIC. • Cleaning methods must be validated according to the worst-case scenario to demonstrate they will reliably achieve their purpose e.g., the removal of allergens, removal of microbiological risk etc. • The equipment used for cleaning must be hygienically designed, well maintained, easily cleanable, and easily identifiable to enable appropriate segregation. • High-pressure hoses must NOT be used for cleaning in any open food rooms.

  • Cleaning Verification and Continuous Improvement • The site must implement a planned swabbing programme to verify that equipment cleaning standards/methods are effective as microbiological and allergenic controls and must act promptly to understand and remedy the cause of out of specification results. • All M&S chilled and high care/high risk manufacturers must use an approved M&S terminal disinfectant in daily open plant cleaning. See Appendix 1: M&S Approved Disinfectants below. • Pine, perfumed or phenolic-based chemicals must not be stored or used on site, including in amenity/toilet areas, as these materials have the potential to taint food products, even at very low levels.

People

  • Fitness to Work • Sites must have systems in place to ensure all employees, including agency workers, are fit to work with food. • There must be an effective return to work process in place which confirms the fitness to work of all employees, including agency staff, before they are allowed to enter food handling areas following illness (including during weekends or bank holidays) or any absence from work outside of their normal working pattern i.e., due to medical conditions other than illness or following annual leave. • The site must have a system in place to ensure employees who have suffered from diarrhoea and/or vomiting are excluded from work for 24 hours for isolated cases, or 48 hours symptom free where infection has occurred.

  • Personal Hygiene • Personnel hygiene rules/standards must be documented and adopted by all personnel at all times, including visitors and contractors.

  • Personal Protective Equipment (PPE) • There must be adequate provision of suitable PPE, to be used by all staff, contractors, and visitors, which is put on in accordance with the site’s documented changing procedure. • Effective laundering must be carried out in-house or by an external company. An external company must have been audited by a competent auditor at a pre-determined frequency to assess hygiene standards, including adequacy of clean/dirty clothing segregation, effectiveness of cleaning (including allergen removal and segregation where appropriate), garment repair/maintenance systems, and freedom from hazardous items e.g., pins, needles.

  • Changing and Entry Procedures • Changing areas and factory entrances must be designed to ensure the correct changing procedures are followed by all people that enter the factory. • Hands must be thoroughly washed and disinfected on entry.

  • Managing Visitors and Contractors • All visitors and contractors must be made aware of the company’s personal hygiene rules and allergen status/rules and must sign to indicate their understanding and acceptance of these rules

Management of Allergens

  • Allergen risk assessment • Suppliers must complete a fully documented site allergen risk assessment. If Allergens Handled On Site: The site allergen risk assessment (RA) must cover the below steps as a minimum – o Step 1a – Raw Material Allergen Matrix o Step 1b – Finished Product Allergen Matrix o Step 2 – Factory Process Flow Risk Assessment o Step 3 – Verification of Risk Assessment o Step 4 – Allergen Improvement Summary o Step 5 – Alibi decision tree

Foreign body detection and prevention

  • Raw materials • Raw material specifications must specify the permitted tolerance for foreign bodies. This level must be realistic for the raw material being purchased, and the capabilities of the industry and the source/supplier of the raw material. Specifications must also specify the preventative measures and controls in place to minimise these risks to the specified level.

  • Raw material intake and handling • As set out in the Hazard Analysis and Critical Control Point (HACCP), raw materials must undergo validated processes (e.g., deboxing, debagging, sorting, cleaning, sieving and/or filtration, magnets, metal detection or X-Ray) to eliminate foreign body risks to the final M&S product. These processes must have documented procedures that are trained to all relevant staff and fully implemented. • Where raw materials are decanted from plastic bags, sites must fully implement their documented bag opening procedure which is designed to prevent and identify any plastic foreign body contamination.

  • Factory environment • The fabric of the factory and equipment must be clean, robust, hygienically designed, and well maintained. • In the event of a foreign body incident in production areas, e.g., glass breakage or pot crush, documented procedures must be implemented to: o Stop production o Isolate potentially affected product and packaging o Restrict personnel in and out of the area o Report breakage to senior management o Remove the hazard by cleaning/removing PPE o Verify the clean has been thorough o Technical release the area back to production o Record actions taken

  • Finished Product Foreign Body Detection • There must be appropriate foreign body detection equipment in place to inspect all finished products, unless indicated otherwise by detailed risk assessment. • The detection equipment must work to the highest possible sensitivities, using the smallest test piece sizes that are the most relevant to the specific product and process. These sensitivities and operational parameters must be validated. • Any finished product rejected by metal detection/X-ray equipment must not be packed for M&S after retesting, regardless of whether it is rejected again. All rejected products must be fully investigated to determine if a foreign body is present and to determine its likely source.

Supplier approval and raw material management

  • Raw Material Management • Raw materials and ingredients must be clearly labelled to allow for easy, unambiguous identification, and use within their shelf life.

Management of water

  • Water Requirements • All water used in the factory as a food ingredient, or for food washing, equipment cleaning, or personal hygiene purposes must be of a potable standard. This means that it must be free from coliforms and E. coli and must comply with the limits for other parameters as set out in the Water Framework Directive. • Water must be classified as low risk or ‘At risk’. ‘At risk’ water must be free from pathogenic microbiological contamination or levels of micro-organisms which may affect product quality and food safety. This can be achieved through filtration or heat/chemical treatment. ‘At risk’ water must be tested weekly

  • • All water supplied by a borehole must be wholesome and clean, and suitable for its intended use. This may require a series of treatments to ensure microbiological, physical, and chemical parameters are met. The necessary treatments must be based on valid methods that address the microbiological, chemical, and physical status of the untreated water. • The complete borehole chamber must be in a secure location, protected from contamination and safeguarded against tampering.

Pest prevention and control

  • Pest Control • If there is any evidence of rodent activity inside factory buildings, as a minimum the area concerned, and its immediate surroundings must be inspected on alternate days (including non-working days) until there have been three consecutive clear inspections. A further follow up inspection must be carried out 1 week later to confirm that eradication has been achieved. • Where raw materials are a known source of infestation, such as flour, these must be sieved to 1 millimetre. All tailings must be inspected and sieved to 1 millimetre daily to check for evidence of stored product insects (SPI).

  • Pest Prevention Contract/Internal Specification • Sites must have a suitable pest prevention and control system in place that covers the whole site and any external storage buildings. This can be provided internally or by and external pest contractor. It must include: o Details of the pests covered by the contract. The inspections must cover all pests liable to infest foodstuffs and packaging materials. o The elimination measures to be used. o Pests excluded from the contract. o The frequency and purpose of all planned visits. o Certain pest species, where encountered, may require separate additional treatment outside the scope of the basic contract e.g., booklice, mites, birds, flying insects, exotic species of ants, cats, and wildlife. Details of these treatments must be included where relevant. o Formal agreement between the supplier and the contractor on who is responsible for removing old evidence of pests (e.g., droppings). o Expected time required to carry out routine inspections by the Technician and Biologist.

  • Pesticide Usage • Internal rodent monitoring stations in open food areas must be non-toxic unless treating an active infestation. Trap-to-kill methods must be considered before internal rodenticides are deployed. Rodenticide used must be so sited as to prevent either accidental food contamination or ingestion by humans or non-target animals.

Traceability

  • Traceability • The site must operate an effective traceability management system with robust and auditable paperwork or electronic records that suitably link each element of the process. The site must be able to successfully complete site traceability exercises on M&S products, within: o 4 hours if the ingredient is not sourced via an international supply chain. o 24 hours if the ingredient is sourced via an international supply chain. o Traceability exercises must be completed regularly, at a frequency based on risk, but at a suggested minimum of every 3 months depending on production frequencies. In addition, trace back to farm, field or boat must be completed on key, or ‘at risk’ raw materials, at least annually.

  • Complaint Handling • All customer complaints must be documented and trended. All foreign body and serious complaints must be promptly and thoroughly investigated to identify their root causes. Where foreign body complaints are received, the start of the investigation must not wait until an actual complaint has been received from a customer.

  • Raw Materials • There must be adequate storage capacity for different raw materials and WIP e.g., dry goods, chilled, packaging, and glass. • Storage areas must be clean and tidy, with all raw materials stored off the floor and away from the walls. A plan must be in place for the regular cleaning of storage areas, including high levels. • Raw materials containing allergens must be easily identifiable and stored in separate, clearly marked areas. They must be fully sealed in their packaging while in storage. • At all stages of storage and transfer, raw materials must be clearly labelled and date coded to ensure traceability. • An effective stock control system must be in place to ensure that raw materials are used within their shelf life. • The use of re-work in M&S products must be approved by the M&S Technologist.

Finished product packing

  • Finished Product Quality Assessment • There must be a documented intake procedure to ensure robust food safety and integrity intake checks are carried out on all raw materials and packaging deliveries.

  • • Suppliers must have suitable average weight systems in place, which are regularly checked in order to pass the Inspector's reference test. Adequate records must also be in place to demonstrate compliance with all aspects of the legislation.

  • • The site must have documented and detailed procedures outlining how to operate manual and automated systems for the verification of packaging and date codes, and actions to take in the event of deviation from the norm. These procedures must be trained to all relevant staff, including those involved in the management of packaging verification and date coding systems.

  • A suitably controlled system is in place for the issue to and return from line of all packaging, including promotional and tray end/outer case labels, which is completed by a trained operator. This can be achieved through a manual record or scanning to line to generate a real-time log of transactions. This process must enable the site to accurately mass balance packaging/labels to understand how many were issued and returned.

  • • Products that are dispatched chilled must be ≤ 5°C (or colder depending on legal requirements e.g., poultry, egg)

Site perimeter and security

  • • The site has appropriate and adequate security to prevent unauthorised access to the site and into factory buildings.

Staff facilities

  • • Staff facilities must be clean and adequate for the number of employees. They must provide toilet facilities, staff changing and lockers which allow for the separation of internal and external clothing. • In order to reduce the risk of chemical, biological, or physical contamination of product, the wearing of protective clothing is not allowed in staff facilities, including in internal smoking rooms and toilets.

Waste management

  • • Effective “clean as you go” procedures must be in place to minimise the build-up of waste during production. • The handling of waste, including allergenic waste, must be controlled to prevent the risk of spillage and/or cross-contamination to other products, people, or equipment.

Environmental microbiological standards and sampling

  • • Sites must have an environmental monitoring plan that has risk assessed all areas of the production facility. The monitoring plan must include: o The static sampling areas, which allow information to be trended. o A programme of investigative sampling. o Dynamic sampling points that change in response to positive and negative trends e.g., a sampling point that is always in specification may be switched to another area to focus on more challenging areas. This keeps the schedule, and the organisms being test for, appropriate to the facility and the products handled. o Food contact areas, indirect food contact areas, and non-food contact areas. o The sampling to be carried out post cleaning and during production.

Integrity Standard

  • Commitment to brand integrity • The site meets the requirements of the M&S Ethical Standard including having an Ethical audit where appropriate and linked with M&S on SEDEX.

  • Management of Supply Chain Integrity • There is a documented chain of custody for all “At Risk” raw materials which identifies every link of the end-to-end supply chain. e.g. Organic blueberry which looks the same as conventional.

  • Management of Factory Segregation • The supplier has identified the Brand Integrity, Product Compositional claims associated with their finished products. (e.g. 'Victoria' plums or county is named etc. i.e. part of a product consumers expect to be of a certain quality are at risk of being substituted for lower quality or alternatives) • Factory layout, product flow and people practices are designed to minimise the risk of segregation breakdown.

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