Principle

Suppliers should be selected on their ability to supply product or service that meets defined requirements. The exact nature of the supplier approval and performance monitoring undertaken will depend on the effect of the purchased product or service on the finished product. The control of incoming products and services is a key prerequisite within a good manufacturing practice (GMP) system.

General

23.1 The management team should develop a supplier quality assurance and performance monitoring procedure that defines the criteria for selection, approval, review and ongoing approval of suppliers and the materials and services they supply to ensure that purchased products and services consistently meet the manufacturing organisation’s requirements. The extent, scope and nature of the procedure will relate to the food products produced and the interface of materials and services purchased with the ability of the manufacturer to produce safe and legal product(s) to the required food safety, integrity and quality standards.

Supplier Quality Assurance

23.2 The quality control manager should have an advisory role in the choice of suppliers of raw materials, packaging, equipment and services. This should include determining if the supplier possesses certification to third‐party assurance technical/management standards or internal company standards, certificates of analysis/conformity and/or in‐house checks. She/he should liaise with actual or potential suppliers in agreeing the relevant material or service specifications, including the assessment of their ability to consistently meet those specifications. The quality control manager should have authority to exclude any actual or potential supplier of material, packaging, equipment or services on the grounds of inability to meet the relevant specification or of unsatisfactory performance or inadequate food safety, integrity or quality control resulting in unreliability of product or service. Assessment of the current status of the supplier’s food safety management system (FSMS), hazard analysis critical control point (HACCP) plan, food integrity management system (FIMS) and their quality management system (QMS) should also be undertaken as relevant to the materials and services supplied. There should be continuous surveillance of supplier performance and internal review of the outputs of that surveillance at designated intervals. The intervals determined for monitoring and/or verification checks should reflect the supplier’s history of conformance with the food manufacturer’s requirements. An approved supplier list should be developed, maintained and routinely reviewed (see 23.7), and this activity should be defined in the supplier quality assurance and performance monitoring procedure.

23.3 The purchasing manager should have authority to place orders with suppliers on the approved suppliers list for raw material lots and services that conform to the relevant specifications. For those raw materials customarily sold on ‘buying sample’, the quality control manager should examine and report on the buying sample, and the purchasing manager should not have authority to disregard adverse findings. Where a delivery of a purchased raw material is found not to conform to the relevant specification or the buying sample, the purchasing manager should initiate and pursue appropriate action with the supplier as defined in the supplier quality assurance and performance monitoring procedure.

23.4 The materials, packaging, equipment and services that should be within the scope of the supplier assurance and performance monitoring procedure include:

1. raw material and ingredient suppliers, both direct suppliers, which could include agents and distributors, and, if required, primary producers;
2. packaging and food contact materials suppliers, including primary and secondary packaging suppliers;
3. water suppliers;
4. equipment suppliers;
5. contract services such as maintenance and servicing, calibration, contract cleaning and retail tray washing services, product testing and laboratory services, transport and distribution services, training providers, contract labour and agency staff, pest control, laundry and catering services, hygiene and waste management and disposal services;
6. subcontracted or outsourced manufacturing and storage operations; and
7. processing aids.

23.5 Ingredient and direct food contact materials (including equipment) will require specific risk or HACCP‐based assessment to determine the areas that are critical to ensure food safety, legality and quality. This assessment will include, but is not limited to, the food safety hazards addressed in Chapters 3, 8, 24 and others. Any exceptions to standard procurement and approval procedures and what actions will be taken should be identified on a case‐by‐case basis, for example where raw material suppliers are prescribed by retail customers, where products are purchased from cooperatives, marketing organisations or agents and where emergency procedures have meant that an alternative supplier is required at short notice to ensure continuity of supply and the timescale does not afford full compliance with the supplier approval and performance monitoring procedure. Factory trials and product development ingredients may also be deemed as exceptions; however, adequate procedures must be in place to ensure that food safety, legality and quality are fully maintained.

23.6 Supplier approval and performance monitoring should be developed on a risk basis and can include, but are not limited to, the following:

• approval of pre‐supply samples, including product performance standards;
• determination of the volume of material supplied and the inherent food safety hazards associated with the material;
• assessment of supplier history and their level of historic compliance with requirements;
• pre‐audit of suppliers’ premises to ensure they meet the required standards, especially in terms of hygiene and the implementation of prerequisite programmes (PRPs) as well as the standards defined within this guide or designated system or customer standard;
• pre‐audit of supplier QMS, FSMS or FIMS from either documentary evidence or completion of a supplier questionnaire. In some cases, both may be necessary. The timescale for reissuing of questionnaires should be determined in the supplier approval and performance monitoring procedure and be based on risk assessment. Suppliers should be required to advise the manufacturer if there is a change to the responses they have made to the ‘live’ questionnaire, for example a loss of certification, product withdrawal or recall, so that the manufacturer can continue to review performance on the basis of all available facts;
• monitoring of their performance during a ‘trial’ period to determine the supplier’s ability to deliver products and services that comply with specified requirements;
• monitoring of their performance over time in complying with the appropriate specifications;
• demonstration by means of a current certificate that the company is certified to a recognised management system standard, for example BS EN ISO 22000:2005 or the British Retail Consortium (BRC) Global Standard for Food Safety;
• certification to an appropriate QMS or FSMS standard for distribution, transport, forwarding, shipping and air transport companies, for example ISO 9000 or relevant BRC standard;
• certificates of analysis or conformity with each delivery;
• development of material sampling and verification procedures to check the veracity of supplier information and pre‐supply samples on an ongoing basis. This could include pesticide residue analysis, heavy metal analysis and microbiological analysis. These sampling and verification activities may be undertaken by the manufacturer or supplier as formally agreed;
• review in the event of the identification of an emerging food safety hazard as a result of new scientific or technical information or a food safety incident that has been identified within the food supply chain;
• follow‐up of instances of non‐conformity of materials and/or service;
• history of supplier in terms of food integrity and more specifically risk of food fraud, a food defence issue or associated illegal behaviour (see Chapter 5); and
• supplier audits and/or inspection checks, where practical, periodically made on suppliers based on risk assessment.

This information is crucial to ensure that suppliers behave with integrity and provide materials and/or services of the correct and consistent quality and that they have addressed any potential food safety, integrity, quality or health and safety issues specific to the materials, equipment and services they supply. This information also provides input into the management review process, ensuring that any non‐conformity is reviewed and then appropriate action taken if required (see Chapter 11).

Supplier audits must be undertaken by competent individuals. An associated audit report must document the audit findings and where necessary any agreed preventive or corrective action. Records showing how the competency of company auditors and/or third‐party auditors has been determined, validated and routinely verified should be retained for a prescribed time period by the quality control manager. The completion of preventive and corrective actions by the supplier, when requested, must be verified to ensure that they have been completed in a timely fashion and that they have been effective.

23.7 The supplier approval and performance monitoring procedure should address the actions to be taken in the event of material, packaging, equipment, finished product and/or service non‐conformity, including supplier delisting procedures. A formal annual supplier review should be undertaken where each supplier’s level of performance is reviewed and any actions required are determined and implemented. Questionnaires should be reviewed and updated at designated intervals to ensure that they continue to reflect supplier standards and third‐party certification status. Responsibilities and timescales for completion should be developed for any resultant actions, which should be followed up at the appropriate time interval to ensure that they have been implemented and have been effective.

23.8 The frequency of testing or verification of purchased materials, packaging, equipment and/or service should be determined by the quality control manager. Materials should be inspected on receipt to ensure compliance with specifications and that traceability has been maintained from the original source. On‐receipt certificates of analysis, certificates of conformity and pre‐acceptance testing (positive release testing) may be required depending on the initial risk assessment undertaken. Packaging that does not undergo quality checks on receipt should be monitored as part of the production quality control checks. Material and supplier risk assessments must be reviewed on a minimum of an annual basis and whenever non‐conformity is identified. Appropriate action must be undertaken to ensure that any changes to procedures and specifications are validated and implemented, and are effective.

Use of Outside Services

23.9 As previously mentioned in 23.4, the supplier approval and performance monitoring procedure also needs to address the range of outside services that could be purchased under contract. These include:

• building repair and maintenance;
• laundering;
• waste disposal;
• specialist engineering maintenance;
• warehousing;
• computer services; and
• advisory services such as business consultants, technical consultants, marketing consultants and legal consultants.

23.10 The contract giver should fully satisfy themselves that a contract acceptor has the appropriate knowledge, skill, facilities, equipment, staff and so on to be able to provide the service in such a way as to contribute to the objectives of GMP. Except in the case of purely advisory service, if the work is carried out away from the contract giver’s premises, the contract giver should have and should exercise the right to visit and inspect any location where the work is performed.

23.11 A contract acceptor should not pass on to a third party any of the work commissioned by the contract giver except with the prior knowledge and consent of the latter.

23.12 In the absence of specific authorisation to the contrary by the contract giver, the contract acceptor should treat as confidential any direct or incidental knowledge gained about the contract giver’s business.

23.13 Arrangements between a contract giver and a contract acceptor should be in writing and should include adequate indication of the agreed respective responsibilities of the parties, and of any special hazards of which either party is aware, and record the authority for the contract acceptor to conduct the work.

Illicit Behaviour

23.14 In agreeing to purchase materials or services from a supplier the manufacturer should consider the potential for illicit behaviour. The scope for illicit behaviour is vast within the food sector so the organisation needs to undertake a focused risk assessment. The scope needs to be defined and should include the materials or products that pose the most risk, the potential types of threats and perpetrators, and how the risk can be effectively mitigated (see Chapters 6 and 7).

23.15 Potential issues that can arise are detailed in Chapter 5, such as product adulteration, substitution, counterfeiting and misrepresentation among others.