Principle

The operations and processes used in manufacture should, with the premises, equipment, materials, personnel and services provided, be capable of consistently producing finished products that conform to their specifications and are suitably protected against contamination or deterioration. Defined manufacturing procedures that address manufacturing operations and associated activities and necessary precautions are required to ensure that all individuals concerned understand what has to be done, how it is to be done, who is responsible and how to avoid mistakes that could affect food safety or quality. For each product, this is provided in the master manufacturing instructions (see Chapter 13).

General

10.1 This chapter deals with those aspects of manufacturing operations and activities that are of general application to any food or drink manufacture. There are, of course, particular additional points and problems concerned with manufacture involving specific types of processing, materials or products. These are the subjects of the chapters in Part II.

Process Evaluation

10.2 Before the introduction of master manufacturing instructions for a product, trials should be carried out to establish whether the formulation and new product brief, and the proposed methods and procedures specified therein, are suitable for factory production and are capable of consistently yielding product that complies with the finished product specification. Validation of food safety process parameters and the effectiveness of prerequisite programmes (PRPs) should also be undertaken at this point and as necessary further amendments and trials should be completed until these conditions are fully satisfied (see Chapters 3 and 12).

10.3 Similar evaluation, and revalidation, should be carried out in connection with any significant proposed change of raw material, equipment or production and/or inspection methods (see Chapters 3 and 12).

10.4 Similar evaluation and review should be carried out periodically to check that the master manufacturing instructions are being followed (see 10.40), that they still represent an effective and acceptable way of achieving the specified product and that they are still capable of consistently doing so (see Chapter 11).

Production

10.5 Adequate resources should be provided in the way of premises, equipment, materials, suitably trained personnel, services, information and documentation, in each case of appropriate quantity and quality (see Chapters 2, 13, 14, 17, 19–24, 26, 28–30, 32–35 and 37–39) to enable the requisite quantity and quality of finished products to be produced.

10.6 Production should be carried out in full compliance with the master manufacturing instructions from which no departure should be permitted except by written instructions from the production manager and the quality control manager, indicating the nature and duration of the departure, and agreed and signed by them. This is often termed a ‘concession’.

10.7 Incentive bonus schemes can create potential hazards and, viewed from the standpoint of food safety and quality, are best avoided. If, however, the provision of an incentive bonus scheme is company policy, it should be so designed as to discourage operators from taking unauthorised shortcuts, for example by building into the formula for bonus calculation a ‘quality factor’ and/or penalty for observed deviation. In general, prevention of unauthorised short cuts is primarily a task for management through supervision. Where operators have ideas for process improvement, they should be encouraged to raise them (e.g. through suggestions schemes) so that they may be properly evaluated.

Operator Procedures

10.8 Operating instructions for production operators should be written in clear, unambiguous, instructional form, and should form a key part of operator training. Due regard should be given to the reading or language difficulties of some operators.

10.9 Particular attention should be paid to problems that may arise in the event of stoppages, breakdowns or emergencies, and written instructions should be provided for the corrective action to be taken in each such case.

Raw Materials

10.10 Each raw material should comply with its written specification.

10.11 Each delivery or batch should be given a reference code to identify it in storage and processing, and the documentation should be such that, if necessary, any batch (see definition) of finished product can be traced back to the deliveries of the respective raw materials used in its manufacture and correlated with the corresponding inspection, testing, laboratory and/or supplier records. Deliveries should be stored and marked in such a way that their identities do not become lost. Procedures should comply with EC Regulation No. 178/2002 of the European Parliament and the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Standards Authority and laying down procedures in matters of food safety (OJ L 031, 01/02/2002 P. 001 – 0024) and Article 11, Traceability, which came into mandatory force on 1 January 2005.¹ Guidance on the general principles and basic requirements for traceability system design and implementation is contained in ISO 22005:2007 (see Chapter 14) and Commission Regulation (EU) No. 931/2011 on the traceability requirements set by Regulation (EC) No. 178/2002 of the European Parliament and of the Council with regard to food of animal origin.

10.12 Deliveries of raw materials should be quarantined until inspected, sampled and tested in accordance with the quality management system (QMS) and the requirements outlined in Chapter 35, and released for use only on authority of the quality manager, taking account of any certificate of analysis or conformity accompanying a delivery. Particular care should be taken where a delivery of containers appears from markings to include more than one batch of the supplier’s production, or where the delivery is of containers repacked by a merchant or broker from a bulk supply. Where appropriate, immediate checks should be carried out for off‐flavours, off‐odours or taints and, particularly in the case of additives, testing should include test of identity, that is, establishing that the substance is what it is purported to be. (NB: In a multi‐container delivery, it is impracticable to check the identity of the contents of every container on arrival, but operators should be trained and encouraged to report immediately anything unusual about the contents when a fresh container is brought into use.)

10.13 Temporarily quarantined material should be located and/or marked in such a way as to avoid risk of its being used accidentally. Material found to require pretreatment before being acceptable for use should be suitably marked and remain quarantined until pretreatment. Material found totally unfit for use should be suitably marked and physically segregated pending appropriate disposal.

10.14 In the case of a bulk delivery by tanker, preliminary quality assessment should be made before discharge into storage is permitted.

10.15 All raw materials should be stored under hygienic conditions and in specific conditions (e.g. of temperature, relative humidity) appropriate to their respective requirements, as indicated in their specifications, and with due regard to the requirements of legislation on substances hazardous to health, for example, in the UK, the Control of Substances Hazardous to Health (COSHH) legislation.

10.16 Stocks of raw materials in store should be inspected regularly and sampled/tested where appropriate to ensure that they remain in acceptable condition and compliant with the appropriate raw material specifications.

10.17 When issuing raw materials from store for production use, correct stock rotation should normally be observed, unless otherwise authorised or specified by the quality control manager. This process is very often termed ‘FIFO’, that is, first‐in‐first‐out stock rotation.

10.18 A formal procedure and associated documentation should be established and followed for the issue of raw materials from store. The personnel responsible for issuing raw materials should be formally defined.

10.19 When a raw material has been issued but not used as planned (e.g. because of a plant (equipment) or production stoppage), the quality control manager or designate should advise as to its disposition. This is critical where items require specific storage conditions such as temperature control in order to maintain food safety or quality.

10.20 Depending on the product being manufactured, the ingredients involved and the nature of the process and equipment, dispensing of the required quantities of ingredients could take various forms, including manual dispensing by weight or volume, automatic dispensing of batch quantities by weight or volume, or continuous metering by volume; the form(s) actually taken will be stated within the master manufacturing instructions. In each case, the weighing and/or measuring equipment should have the capacity, accuracy and precision appropriate to the purpose, and the accuracy should be regularly checked (see Chapter 34).

10.21 Where batch quantities of a raw material have to be dispensed manually into containers in advance, this should be done in a segregated area. Where manual pre‐dispensing of relatively small and accurate quantities (e.g. additives) is required, this should be done by, or under direct supervision of, competent staff.

10.22 Records should be kept to enable the quantities of materials issued to be checked against the quantity or number of batches of product manufactured.

10.23 Where an operator controls the addition of one or more raw material to a batch, the addition of each ingredient should be recorded at the time of inclusion on a batch manufacturing record to minimise risk of accidental omission or double addition. Ingredients with key health and safety implications may need to be formally signed off before addition to the batch, for example allergens or preservatives.

Packaging Materials

10.24 Each item of packaging material should comply with its specification (including any legal requirements). The specification should be such as to ensure that:

1. the product is adequately protected during its expected life under normally expected conditions (with a safety margin for adverse storage);
2. in the instance of packaging coming into immediate contact with the product, there is no significant adverse interaction between product and packaging material. In the European Union (EU), this includes compliance with the EU Framework Regulation (EC) No. 1935/2004,² which defines general requirements for all food contact materials, and a number of specific directives that cover single groups of materials and articles listed in the framework regulation, as well as directives on individual substances or groups of substances used in the manufacture of materials and articles intended for food contact;
3. where the packaged product undergoes subsequent treatment, whether by the manufacturer, caterer or consumer, the packaging will adequately stand up to the processing conditions and no adverse packaging/product interaction occurs;
4. the packaging is capable of providing the necessary characteristics and integrity where the preservation of the product depends on the pack; and
5. the finished pack will carry the statutory and other specified information in the required form and location.

10.25 Where packaging material (e.g. labels, printed packages, lithographed cans) carries information required by law, the quality control manager should ensure that the specification is updated as required to comply with new legal provisions. In some organisations this responsibility may be within the product development department. The quality manager should ensure that stocks of packaging materials that no longer comply are quarantined for modifications (if possible and desired) or destruction. Similar provisions and precautions should apply in the case of contract packing for a customer where the latter requires changes to other label information (see Chapter 33). The requirements under good manufacturing practice (GMP) for smart packaging, including active and intelligent packaging, are included in Chapter 25.

10.26 Each delivery or batch of packaging should be given a reference code to identify it in storage and processing, and the documentation should be such that, if necessary, any batch of finished product can be traced to deliveries of the respective packaging materials used in its manufacture and correlated with the corresponding laboratory records. Deliveries should be stored and marked in such a way that their identities do not become lost (see Chapters 14 to 16).

10.27 Deliveries of packaging material should be quarantined until inspected, sampled and tested in accordance with the QMS and Chapters 28 and 30, and released for use only on authority of the quality manager. Deliveries of packaging should be adequately inspected to confirm that they comply with the relevant specification and that the external packaging is intact and unopened. Damaged, previously opened or dirty cartons of packaging must not be accepted due to the risk of contamination. Operators should be trained and encouraged to report immediately anything unusual about the appearance, odour or behaviour of packaging materials issued, especially colour differences, changes in print quality or problems with sealing.

10.28 Temporarily quarantined packaging material should be located and/or marked in such a way as to avoid risk of its being accidentally used before release. The personnel responsible for the decision on its disposition should be formally defined. Material found totally unfit for use in packaging operations should be suitably marked and physically segregated pending appropriate disposal.

10.29 All packaging materials should be stored in hygienic conditions and as indicated in their respective specifications.

10.30 Stocks of packaging materials in store should be inspected regularly to ensure that they remain in acceptable condition, and appropriate infestation/pest control procedures must be in place for storage areas (see Chapter 22).

10.31 In issuing packaging material from store for production use, stock rotation should normally be observed, unless otherwise authorised or specified by the quality control manager. This process is very often termed FIFO stock rotation.

10.32 A formal procedure and associated documentation should be established and followed for the issue from, and the return of, part‐used batches of packaging to store. The procedure should address the need to reseal part‐used boxes of packaging to prevent foreign body contamination. The personnel responsible for issuing and reconciling packaging stocks should be formally defined.

10.33 Where a company manufactures more than one product, or more than one version of a single product, the greatest care should be taken to check that the correct packaging is issued for the product to be manufactured, and that no incorrect packaging materials left over from a previous production run of a different product or a different version are left in the production area, where they might accidentally be used. This is especially important when products are placed on promotion and the packaging specification is amended, and then after a given duration the product is packed in the original packaging. Particular attention should be paid to controlling adhesive, flash and price labels, especially where the design of the labels is very similar.

10.34 Under no circumstances should primary food packaging be used for anything other than its intended purpose.

10.35 Where packaging is reference coded, priced or date marked for use, care should be taken to ensure that only material carrying the correct production date is used. Surplus material left from earlier production runs and no longer bearing a valid reference or date should not be left in the production area. Where the reference and/or date is applied during the manufacturing operation, care should be taken to check and ensure that the marking machine is set for the correct reference and date. Where packaging or labels are generated in an off‐line print room, procedures need to be in place to sign off/verify that the print details are correct when released from the print room and when accepted by the production line. A protocol should be in place to ensure that any unused packaging or labels are suitably controlled so that they cannot be inadvertently used in production. Label approval, monitoring and verification activities must be formally defined and appropriate training given to those personnel assigned these tasks so they understand the meticulous inspection required and the consequences if an incorrect label is not identified and used within production. Crisis management, product recall and product withdrawal procedures must be in place that address the procedures to be followed in the event that incorrect product labelling has occurred, especially if the product is known to, or may potentially, contain an allergen that is then not identified on product labelling/packaging (see Chapter 27).

Processing and Packaging

10.36 Where a company manufactures more than one product or more than one version of a product, and there is more than one production line, production layout should be such that confusion and possible cross‐contamination are avoided (see 9.6).

10.37 Whether in single‐line or multiple‐line production, particular care should be taken in terms of production layout and practices to avoid cross‐contamination of one product by another (see 9.6).

10.38 On a production line, in order to avoid confusion, the name and appropriate reference to the product being processed or packaged should be clearly displayed or otherwise communicated.

10.39 Before production begins, checks should be carried out to ensure that the production area is clean and free from any products, product residues, waste material, raw materials, packaging materials or documents not relevant to the production to be undertaken, and that the correct materials and documents have been issued and the correct machine settings have been made. All plant and equipment should be checked as clean and ready for use. A formal form or checklist may be designed for this purpose.

10.40 Processing should be strictly in accordance with the master manufacturing instructions subject to any variations approved (as in 10.6), and by detailed procedures set out for operators in the plant operating instructions. Master manufacturing instructions, product or process specifications should define the following:

1. pre‐startup, close‐down and product changeover checks to ensure the line is cleared for production and closed down correctly at the end of the shift;
2. the product recipe in terms of ingredients and proportions;
3. mixing instructions, including machinery to be used, duration of mixing and processing requirements;
4. equipment settings and processing parameters (time, pressure and temperature);
5. the control of in‐process monitoring devices and divert systems if minimum processing parameters are not reached;
6. filling requirements in terms of volume or weight;
7. criteria for in‐process foreign body inspection or detection;
8. inspections to ensure processing conditions are consistent throughout the batch being processed;
9. packaging and labelling requirements, especially at start‐up and product changeover;
10. sampling criteria in terms of parameters to be checked and the frequency of sampling; and
11. additional food safety and quality criteria.

10.41 Process conditions should be monitored and process control carried out by suitable means, including, as appropriate, sensory, instrumental and laboratory testing, and on‐line checking of correct packaging and date marking. Where checkweighers, filler systems, continuous recorders or recorder/controllers are in use, the data produced should be checked by quality control and charts or printouts retained in either electronic or paper form as process records. This is particularly important at process steps that are deemed by the manufacturer as a critical control point (CCP) for a food safety hazard (see Chapter 3).

10.42 There should be regular and recorded checks by appropriate personnel on the accuracy of all instruments used for monitoring processes (e.g. temperature probes/gauges, pressure gauges, flow meters, checkweighers, colour measurement devices, metal detectors and X‐ray machines). The frequency of checks should be established to ensure that instruments are always correctly calibrated, with an accuracy related to national standards (see Chapter 34).

10.43 Effective cleaning of production premises and equipment must be carried out (see Chapter 21).

10.44 All persons working in or visiting the production area must comply with the requirements of personal hygiene and adequate facilities must be provided, as summarised in Chapter 17.

10.45 General ‘good housekeeping’ should be practiced, including prompt removal of waste material, precautions to minimise spillage or breakage, prompt removal and clean‐up of any spillage or broken packaging, and the removal of any articles that might enter the product as foreign matter, otherwise known as a ‘clean‐as‐you‐go’ policy (see Chapter 21).

10.46 Where appropriate, foreign matter detectors should be used (see Chapter 9).

Intermediate Products

10.47 After its preparation, an intermediate product should be held until checked and approved by quality control for compliance with its specification. If required to be stored before further processing, it should be stored as designated in the specification, and suitably reference marked and documented so that it can be traceable and correlated with the lots of the raw materials from which it was made and the batch(es) of finished product in which it is subsequently incorporated (see Chapter 14).

10.48 A batch of intermediate product found to be defective should be quarantined pending re‐working or recovery of material or outright rejection as the case may be. The personnel responsible for the decision on its disposition should be formally defined (see Chapter 29).

Finished Product

10.49 Packed finished products should be quarantined until checked and approved by quality control for compliance with the appropriate finished product specification.

10.50 An approved batch of finished product should be suitably marked to identify it, and stored under the appropriate conditions (e.g. of temperature or relative humidity) stated in the finished product specification. Under the traceability requirement of EU Regulation No. 178/2002, an identification mark must be provided linked to a traceability document to any retailer to whom part of that batch is sold.

10.51 Where a batch of finished product fails to meet the specification, the reasons for failure should be thoroughly investigated. Defective finished product should remain quarantined pending re‐working or recovery of materials or disposal as the case may be. The personnel responsible for the decision on its disposition should be formally defined (see Chapter 28).

Storage

10.52 Desirable features of storage premises are outlined in Chapters 19 and 26. Aspects of storage of goods in the distribution system are dealt with in Chapter 32.

Transport

10.53 Materials or products should be transported within the factory premises in such a way that their identities are not lost; that there is no mixing of materials or products approved for use or despatch with those that are quarantined; that by‐products, particularly those not intended for human food use, do not lead to contamination of other materials; that spillage is prevented; no breakage or other physical damage is caused to the goods being transported; and that goods being transported are not left in adverse conditions or otherwise allowed to deteriorate. Aspects of transport of goods in the distribution system are dealt with in Chapter 32.