Principle

Ensuring the safety, legality and quality of products requires the development of testing and inspection procedures to ensure that the food products are safe, wholesome, comply with relevant legislation and meet consistently designated specifications. Testing and inspection procedures should enable the relevant parameters to be monitored so that corrective action can be taken if results fall outside specified limits. The term ‘quality control staff’ is used below, but it should be recognised that individuals with alternative job titles may undertake these tasks within the manufacturing environment depending on the specific allocation of tasks. This chapter should be read bearing this caveat in mind.

General

35.1 Quality control staff need to be aware of the specified target levels and tolerances, critical limits and control limits for the raw material, ingredient or product being tested. Good laboratory practice is addressed in Chapter 38. Any external laboratory services used must be monitored as per the supplier approval and performance monitoring procedure (see Chapter 23).

35.2 Quality control personnel should have the authority to hold product considered to be outside specified parameters or limits. They must then refer the matter to the appropriate manager for his/her formal decision on disposal.

35.3 Product control, testing and inspection checks should be scheduled throughout the manufacturing process, including intake, on‐line and despatch checks. Quality control and/or process records must be completed for all batches/consignments at the time the test, check or inspection is undertaken and should be held on file for both internal reference and customer or third‐party auditor review. Historical control and process records should be held according to the controlled records list (see 13.10). Any changes to these records must be authorised by an appropriate individual and the reasons for the change recorded as well as the name of the individual who approved the change.

35.4 Quality control procedures should be developed by the quality control manager considering the following:

• the product characteristics to be assessed and the acceptance criteria;
• the ‘volume’ of product that constitutes a batch and the information that can be used to identify that batch and where it should be recorded;
• the sampling accuracy and whether the sample is indicative of the whole batch;
• the equipment required, the appropriate measurements to be taken and the degree of accuracy required for the equipment;
• the skills, training and qualifications required by quality control personnel;
• the points in the process where the measurements will be undertaken and the frequency of checks;
• the actions to be taken in the event of non‐conformance;
• the documentation to be completed that records the results of inspection; and
• the requirements for verification of the results of product testing.

35.5 Product characteristics/criteria to be assessed at each process stage should be defined in a quality plan, food safety plan or equivalent. Product characteristics/criteria may also be described in individual customer specifications and could include:

• sample size, which may be determined by legislation, customer requirements or internal procedures. It is important to ensure that the sampling is large enough to be representative of the batch being tested;
• product temperature, especially where it is critical to control food safety;
• traceability as required by the specification;
• provenance: origin, livestock breed and variety. If there are varietal differences such as with produce, especially where there is a legal requirement to label the product with varietal declaration, this must be adequately controlled. The material must be checked to ensure that it is from an approved source, is of the correct provenance if this has been determined as a requirement and is as specified in accompanying documentation. If the material is specified as being from a certified source, for example organic, kosher or farm assured, then identity preservation must be maintained through the manufacturing process;
• quality and appearance. The product must be assessed as per internal/customer specification, including, as appropriate, intrinsic standards such as smell, colour, size and shape, maturity, eating quality, freshness, firmness and cleanliness or level of soiling;
• specific product characteristics that are applicable to individual ingredients and products, for example pH, water activity (a_w), sugar content (% Brix), salt content and preservative levels; and
• packaging in terms of compliance with specification, signs of damage, correct labelling and product information (see 35.11).

35.6 Any material or product failing to meet criteria defined within the specification must be placed on hold and suitably marked and/or held in a quarantine area awaiting a decision on its disposition.

35.7 If the material or product fails to meet the specification at any stage in the process, then it should be held and the quality control manager informed. (S)he should decide, with other members of the management team as necessary, the final product disposal. Disposal will be to reject, to use under concession, to supply to an alternative customer whose specifications it meets or to reprocess or rework material. The appropriate action should be taken only on the written authority of the quality control manager. Causes of non‐conformance should be recorded and analysed, and corrective action initiated to prevent recurrence. Corrective action needs to be documented and followed up to ensure that it has been completed and is effective (see Chapter 28).

Quantity Control

35.8 Quantity control systems can be based on average quantity or minimum quantity. The procedure for quantity control should meet the minimum requirements of legislation and also the customer requirements as defined in the product specification. Quality control and production personnel must be aware of the minimum gross pack weight/volume required for each individual pack/production line (including stated product weight/volume, packaging tare weight and any weight loss allowance for product that could dehydrate over its shelf‐life duration). Packed product may also be sold to a specific count. Where bulk product is not subject to legislative requirements, it must conform to the relevant specification.

35.9 All weighing scales and weighing equipment should be tested daily against standard test weights that have themselves been calibrated and are traceable to national standards. The results should be recorded on the appropriate record. Before commencing work, the production and/or quality control personnel, as applicable, should ensure that the equipment they are using is working correctly and is suitable for use. At the end of the production shift, they should ensure that the equipment is left in good working order. In the event that equipment is broken, the quality control manager, or designate, should be informed so that (s)he can arrange for the equipment to be repaired and determine the need for product to be held, withdrawn or recalled.

35.10 The use of statistical process control (SPC), especially with automatic filling machines or checkweighers, can assist in the minimisation of ‘giveaway’ and ensure effective control of product weights and thus productivity. The roles and responsibilities for quality control and production personnel in implementing the quantity control systems need to be formally defined and routinely assessed to ensure compliance with legislative requirements and product specifications.

Label Control

35.11 Product labels should be kept in a designated area until required by production. Procedures should be in place to prevent unauthorised use of labels and the risk of fraudulent activity associated with a given product. Labels should be issued from this area to authorised personnel, and any unused/returned labels should be signed back in and accounted for at the end of production. During product changeovers, all packaging and labelled materials, especially flash or promotional labels, should be removed from the line and the line should be approved by the line supervisor or designate that it is ready to start manufacture of the next product. In the event that labels from previous production runs are found on the production line, the quality control manager should be informed immediately and appropriate action taken, including the potential withdrawal of product from the distribution system. All actions taken should be documented.

35.12 Quality control personnel should approve labels prior to use. The label should be checked by at least two and preferably three competent individuals before it is approved for production. This should be recorded on the appropriate quality record. The quality checks should include as applicable to the label and relevant product specification:

• label format (portrait or landscape) and position on the pack, especially in relation to additional flash or promotional labels;
• product label design and descriptions, including brand owner’s name and address, quantitative ingredient declaration, nutrition labelling and claims;
• print registration and quality;
• colour coding (where applicable, e.g. on box end or tray labels);
• product, variety and country of origin;
• volume, weight, size or count;
• bar code (readability to be confirmed by use of an approved bar code scanner and verifier);
• customer department/commodity number (where applicable);
• processing plant/supplier identification number/code;
• durability date: use by, display until or best before, or a combination of the latter two, depending on specific customer requirements;
• price (where applicable); and
• print clarity through the production run and correct size of print.

The first and the last label of product, pack and tray end should be checked from each batch (reel) of label, signed off and affixed to the quality control record. If film is printed on‐line, then samples of printed film should be retained. Labels should be checked at designated intervals during the production run for continued conformance. The frequency of checks could relate to a period of production time or production volume, for example every 30 minutes, every hour or every pallet.

Shelf‐life Assessment

35.13 Samples should be held for the designated time period and tests carried out as detailed in individual internal/customer specifications. If any rapid deterioration of the product occurs, this should be referred to the quality control manager or designate so that appropriate action can be taken. Shelf‐life samples may be held at different temperatures, including frozen, chilled, ambient or accelerated storage. Shelf‐life records should be retained and analysed for potential trends. In the event of failure of a given batch to meet safety or quality criteria during the duration coding of the product, appropriate corrective action should be implemented.

Despatch Quality Control Procedures

35.14 Quality checks and the temperature of all products must be taken prior to despatch and noted on the appropriate record. If the finished product is subject to positive release checks, then these must all be undertaken, recorded and signed off if fully compliant so that the batch/load can be formally released for distribution. Positive release procedures should be documented and implemented, and only authorised personnel may formally release a product as specified in the procedure(s). The traceability information on these records should concur with those on the delivery and despatch notes.

Food Safety Monitoring and Verification

35.15 Food safety monitoring and verification activities will be undertaken in line with the prescribed requirements of the food safety management system (FSMS) and/or hazard analysis critical control point (HACCP) plan. The testing undertaken at both control points and critical control points (CCPs) should demonstrate that the process or product complies with the required critical limits and/or target levels and tolerances where these have been defined. Verification activities will also include product inspection and testing activities such as shelf‐life testing, testing of products from the retail shelf and other tests as identified by the FSMS.