Principle

It may not necessarily be enough to assume that the description of a consignment of a raw material on the packages or on the corresponding invoice is accurate. Where the identity is not absolutely obvious beyond question, the identity of each consignment of raw material should be checked to verify that it is what it purports to be. Product identification and traceability systems must be able to trace materials from source to finished product and also from product to source. The system should be routinely tested to demonstrate that it is implemented and effective. Product identification and traceability procedures are a key prerequisite to ensuring good manufacturing practice (GMP).

Product Identification

14.1 Examples of raw materials whose identity may be obvious beyond question are many fruits and vegetables (although where a particular variety or cultivar is specified, the manufacturer receiving a consignment will need to determine that it is of the cultivar specified).

14.2 Major examples illustrating the dangers of simply assuming that raw materials are what they are supposed to be are common. The inadvertent use, by some manufacturers, of what subsequently was revealed to be unfit raw materials can lead to contaminated food batches that are then subject to recall or, where an animal feed manufacturing operation is involved, the slaughter of animals in the supply chain who have been potentially fed contaminated feed, for example the problems that have occurred in the past with dioxin‐contaminated feed.

14.3 In evaluating a supplier’s premises and operations, attention should be paid to, and account taken of, the safeguards operated by the supplier against mistaken identity of materials supplied to them and then subsequently materials leaving their facilities.

14.4 In some instances, checking a raw material delivery for compliance with its specification will also establish its identity. Where this is not the case, consideration should be given to building into the inspection schedule a check to verify the identity of the material received. It would be a mistake to assume that because an ingredient may be a clearly defined chemical entity, supplied by a reputable supplier who gives assurances as to compliance with legal purity requirements, that its identity may be taken for granted. Chemical manufacturers who manufacture food additives often also manufacture other chemical substances for non‐food use and thus are not food grade, and mistakes or mislabelling or ill‐intent could occur. Due to the seriousness of the potential food safety hazard or food integrity threat (see 5.1) involved in such an occurrence, it is all the more important that each consignment of an additive or ingredient should also be checked to verify its identity and that it is food grade and it is what it purports to be. In the instance that fruits and vegetables are imported, then on receipt it is important to assess that the designated country of origin (COO) is recorded and it is verified that it is indeed correct. Where imported food is processed in establishments approved through either legislative means or third‐party certification, it is important that product identity and traceability to a given processing unit are established on physical labelling and/or the associated documentation and verified by staff at the manufacturing unit on receipt. If it is not possible to verify this at receipt verification must occur before use, for example if container consignments cannot be broken down on receipt for verification of all pallets, boxes or other net units of supply contained within the batch the identity of the units must be determined at the start of production activities, when it is practicable to check and verify such information.

Traceable Resource Units

14.5 It is important for the manufacturer to have a clear communication strategy for the terminology used to determine traceability and describe how traceability is embedded within their systems and procedures. The term traceable resource unit (TRU) is often used. This has been described as a unique batch of material or product that, using a specific set of traceability characteristics, is readily distinguishable from other batches of material. A batch is therefore an identifiable amount of product or material that has undergone a given treatment or process at a given time in a given location. ISO 20005:2007 defines a lot as ‘a set of units of a product which has been produced and/or processed or packaged under similar circumstances’. Alternatively, vocabulary is used in the manufacturing sector such as lot (a group of items defined by the manufacturer; see also 14.9), trade unit (a quantity defined at its lowest repeatable unique unit, e.g. jar, box, pack, bag) and logistic unit (a quantity defined at its lowest repeatable unique unit for storage or transportation, e.g. tray, box, pallet or container).

14.6 The challenge for the food manufacturer is that a given TRU is constantly changing in terms of physical and traceability characteristics within the manufacturing process. The manufacturing activities employed, including mixing, addition, separation, splitting, aggregation, joining, storing, transfer, rejection and reassembly, mean that continuously new TRUs are created. Many manufacturing operations are not in themselves discrete, i.e. individual batches produced one at a time that can be identified by time and location (e.g. bin or tank number or time of cleaning between one day of production and the next), instead they are continuous and cannot be differentiated. An example of continuous batches is the ongoing refilling of a bulk bin with a raw material, e.g. milling wheat on receipt in a bulk bin in a flour mill or a bulk ingredient silo in a manufacturing unit. Thus each manufacturer needs to be very clear as to which of their processes are discrete and which are continuous, and as a result how they are going to develop a product identification and traceability procedure that is appropriate, implemented, monitored and verified on a regular basis to ensure its efficacy.

14.7 Traceability has two aspects: first, the ability to trace a product back to the start of the production process and, second, to track a product from a given point in the manufacturing process to despatch, then subsequent stages and ultimately to the consumer. This means that together with the physical movement of material from stage to stage in the process there also needs to be an associated information system. The information system can create transparency within the manufacturing process and capture a number of details about the product. These criteria include material and product history, the time the material spends at different stages of the supply chain and in whose ownership, who was involved with making the product, how the product has been stored, which is especially important if temperature control is critical (e.g. the cool‐chain), the diverging of product flows if materials are used in different products and the destination of by‐products, waste (e.g. if it is used in animal feed) and details of provenance such as country of origin, method of production on farm (such as organic, conventional production), geographic origin etc.

Traceability

14.8 The EU Regulation No. 178/2002 defines traceability as the ability to trace and follow a food, feed, food‐producing animal or substance intended to be, or expected to be, incorporated into a food or feed through all stages of production, processing and distribution. The legislation requires that an item can be traceable ‘one‐step forward and one step back’, sometimes called business‐to‐business (B2B) traceability. Market requirements may mean that traceability requirements are more in‐depth, requiring businesses to trace from field to fork. This means that not only is there physical movement of product from step to step in the supply chain, there is also a data trail from the start to the end of the chain. Manufacturers need to determine what their TRU is in terms of a batch or a lot. However, with reassembly and mixing during the manufacturing process, as previously described, the definition of the batch can change and new batches are created that need to be linked to the previous steps in the chain. As a result, whilst regulation 178/2002 outlines the minimum legal requirement for traceability, market requirements are increasing the need for technology to capture wider amounts of data (see Chapter 16).

Lot Marking Regulations

14.9 The Food (Lot Marking) Regulations 1996 (as amended) set out the lot marking requirements to be applied to all foodstuffs sold for consumption (unless specifically exempted), including wines and spirits. They implement Council Directive 89/396/EEC on indications and marks identifying the lot to which a foodstuff belongs as amended by 91/238/EEC¹ and 92/11/EEC. The directive establishes a framework for a common lot (or batch) identification system throughout the EU so that a product recall can be implemented if required. It is for the manufacturer or other appropriate business in the supply chain to determine the size of a lot. It is important that the size of the lot reflects the practicality of a potential product recall. The Food (Lot Marking) Regulations 1996 (as amended) defined a lot as ‘a batch of sales units of food produced, manufactured or packaged under similar conditions’ and lot marking indication as ‘an indication which allows identification of the lot to which the sales unit of food belongs’.

Genetically Modified Organism Regulations

14.10 EC Regulation No. 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms (GMOs) requires that ‘traceability requirements for GMOs should facilitate both the withdrawal of products where unforeseen adverse effects on human health, animal health or the environment, including ecosystems, are established, and the targeting of monitoring to examine potential effects on, in particular, the environment. Traceability should also facilitate the implementation of risk management measures in accordance with the precautionary principle’.²

Traceability requirements for food and feed produced from GMOs must be established to ensure accurate labelling in accordance with the requirements of EC Regulation No. 1829/2003 on genetically modified food and feed to ensure accurate information is available to operators and consumers and to enable control and verification of labelling claims. In the UK, the provisions from these statutes have been incorporated into the Animal Feed (Composition, Marketing and Use) (England) Regulations 2015 and equivalent legislation.

Provenance, Identity Claims and Assurance Status

14.11 Where claims are made on the finished product, it is important that the ingredients or the product itself in reality comes from the said designated provenance, or has the designated identity or assurance status in practice, for example Fairtrade, organic, or designated COO. The manufacturing organisation must have a suitable identification and traceability procedure in place to demonstrate the status of raw materials, in‐process material and finished product, especially with regard to such claims. Records should be maintained to demonstrate that the materials sourced and the finished product comply with the legal requirements associated with such claims. This is discussed in more detail in Chapter 15.

Traceability Procedure

14.12 BS EN ISO 22000:2005 Food safety management systems – requirements for any organisation in the food chain states that a traceability system should establish and enable the identification of product lots and their relation to batches of raw materials, processing and delivery records. It is important to consider the scope of the product identification and traceability system, and the associated data requirement and whether the scope of the traceability system includes food safety and legislation, food quality and food integrity within its boundary of operation.

Four types of traceability systems have been defined:

• track‐and‐trace based integrity systems concerned with identity preservation through each step in the process;
• volume‐based integrity systems concerned with the ability to track by weight or volume where a given TRU has gone. These types of traceability systems are often called mass‐balance systems;
• separation‐based integrity systems concerned with segregation and the ability to isolate a given TRU from others; and
• certificate‐based integrity systems concerned with how identity and traceability can be assured by the data and documentation that accompanies the TRU. These are sometimes called book and claim systems.³

It is important for the manufacturer to be clear as to the type of traceability system they have adopted to ensure food safety, legality and quality have been maintained. A documented procedure should be developed and implemented to ensure that, throughout all stages of an organisation’s operations, raw materials and in‐process items and finished products are identified and traceable. Packaging and processing aids should also be traceable to an individual delivery and/or batch. The quality control manager is responsible for the implementation and validation of this procedure. Guidance on the general principles and basic requirements for traceability system design and implementation is contained in ISO 22005:2007.

14.13 In practical terms, for traceability to be effective, the responsibility of each organisation is to ensure the ‘link’ in the food supply chain is not broken. This requires an organisation to satisfy itself that its supplier of a food material has carried out checks to ensure that the documentation provided accurately describes the nature and substance of that material and its status. The organisation should retain that documentation and, following the manufacturing process, issue documentation/labelling to the organisation to which they in turn sell the food product which can link back to all previous processes and stages that the associated TRU has gone through. Where reworking/repacking operations are being performed, traceability must be maintained through quality control documentation.

14.14 The product identification and traceability procedure should include both internal traceability, i.e. of products and materials within the control of the manufacturer and external traceability that covers tracking and tracing at all stages of the supply chain. The quality control manager or designate should ensure that the product identification and traceability procedure is tested at prescribed intervals. These tests should interface with the crisis management, complaints and product recall proctols, and the testing of traceability should include a variety of potential scenarios (see Chapter 27). This traceability test should include a mass balance or quantity test (see above), i.e. that the volume/weight of the product in the designated TRU can be fully traced/tracked from intake to despatch or vice versa. This requires any reworked, regraded or waste product to be fully recorded within manufacturing records. As part of the management review and internal audit process each manufacturing unit should also undertake a formal assessment to determine the level of traceability achieved in practice and whether in the event of a product recall further batches should be automatically recalled. This assessment should also include a determination of the timescales that are acceptable for the traceability audit to be completed, for example what documents should be available within 2 hours, 4 hours, 8 hours and so on.