Principle

The full significance of a food safety, integrity or quality complaint may only be appreciated by certain responsible persons, and then possibly only with the knowledge of other related complaints. A procedure must therefore be provided for the appropriate channelling of all complaint reports and the analysis of complaint data. A product defect coming to the manufacturer’s attention, whether through a complaint or otherwise, may lead to the need for a product withdrawal from the retail distribution system, or a public product recall also involving return of products by members of the public. There should be a predetermined written plan, clearly understood by all concerned. It should address the withdrawal or recall of a product, or a known batch or batches of product known or suspected to be hazardous or otherwise unfit, or the withdrawal or recall of wholesome but substandard product that the manufacturer wishes to withdraw or recall. A crisis management procedure should be established should such a situation arise and the members of a crisis management team should be defined within the procedure. This procedure is a key prerequisite of good manufacturing practice (GMP).

Complaints

27.1 The system for dealing with complaints should follow documented procedures that indicate the responsible person, and their deputy, through whom the complaints must be channelled.

27.2 If the responsible person is not the quality control manager, the latter should be fully informed and closely consulted. The responsible person should have the appropriate knowledge and experience, and the necessary authority to decide the action to be taken in the event that a complaint arises.

27.3 Where possible, product food safety, legality and quality complaints should be thoroughly investigated by the quality control manager, with the cooperation of all relevant personnel, and a report prepared as a basis for action and for the records. This report could be analysed as part of the management review process (see 11.2). This process should be robust enough to differentiate between one‐off incidents and an ongoing trend.

27.4 Corrective action should include responding to the complainant, and if required responding to any enforcement authority involved. Where the complaint is justified, steps to remove or overcome the cause and thus prevent recurrence should be taken, and the defective material that the complaint sample might represent should be dealt with as necessary, including possibly a product withdrawal or recall. Root cause analysis should be undertaken to identify the factors that have caused the incident so that appropriate preventive and corrective action is implemented and is effective (see 28.10–28.12).

27.5 Complaint reports should be regularly analysed, summarised and reviewed for any trends or indication of a need for a product recall or of any specific problem requiring attention. It is strongly recommended that appropriate summaries that include comparative data are developed and that they are regularly distributed to directors and senior management and subject to formal management review (see Chapter 11). Trend analysis should relate the number of complaints to volume produced to give a better reflection of performance, such as complaints per 100,000 units or complaints per million units sold/produced. Whether the complaints should be related to products sold or produced will depend on the seasonal variation of production and also the products’ indication of durability. Fluctuations in production levels/purchasing levels could, if not taken into consideration, potentially skew the trend analysis for a given month or quarter. Measurable indicators such as complaints per million units sold, percentage compliance with agreed service level or rating of types of complaint should be developed and form part of the management review process.

Product Withdrawal and Recall

27.6 The type of occurrence that constitutes a product incident should be determined. As there are so many types of incident that could occur, it is not possible in this publication to give a definitive list or be specific on the actions to be taken in each instance. The type of product incident likely to occur will be specific to the product and its ingredients, the process employed in preparing, storing and manufacturing the product, and the frequency of reworking or regrading activities, which in turn will reflect ongoing supplier performance at meeting material specifications and the overall effectiveness of the quality management system (QMS), the food integrity management system (FIMS) and the food safety management system (FSMS). An incident could be contamination due to an allergenic, biological, chemical or physical hazard whether accidental or malicious, human contamination such as blood or other material, adulteration and/or any other incident that could affect the quality, safety or legality of the product, such as incorrect labelling or incorrect use of ingredients.

27.7 A responsible person, with appropriate named deputies, should be nominated by senior management to initiate and coordinate all withdrawal and recall activities, to liaise with retailers and to be the point of any contact on withdrawal and recall matters with regulatory authorities as applicable to the incident.

27.8 The design of manufacturing records systems and distribution records systems, and the marking of outer cartons and of individual packs should be such as to facilitate effective withdrawal or recall if necessary. A good system of lot or batch marking will pinpoint the suspect material and help avoid excessive recall. Lot and/or batch marking of food ingredients and products is a requirement of regulatory and market requirements (see Chapter 14).

27.9 There should be written withdrawal and product recall procedures, and they should be capable of being put into operation at short notice, at any time, inside or outside working hours. To ensure this is possible, an out‐of‐hours contact list should be maintained and include contact details for staff, contractors, suppliers, customers, emergency services, specialist laboratories, legal advisers, certification bodies and government and enforcement regulatory bodies. Procedures should also include a communication plan, which details the communication levels both internal and external to the organisation as well as media communication that would be used in a full product recall.

27.10 The procedures should be shown to be practicable and operable within a reasonable time by carrying out suitable testing of the procedures. The product withdrawal/recall and management of incidents system must be tested at least annually to determine the effectiveness of the system both for traceability from the finished product to raw materials and packaging materials used and tracking from a batch of raw material to the individual batches of products that it was used to make.

27.11 It is important to test the product withdrawal/recall procedure for a range of incidents. For example, a test could be undertaken for glass contamination, metal contamination or an instance of contamination at the supplier and a number of other scenarios. Each type of incident will require a different audit trail, and only by rotating the type of incident that is tested will the organisation be able to demonstrate the true effectiveness of the product recall and withdrawal procedure across a range of potential incidents that could occur. If the product recall test is only undertaken to test the ability to trace a production code to a retail depot or from depot to supplier, it is in effect only a traceability test. Thus, in the event of a glass contamination incident, the ability of the organisation to collate the data and records required will never be tested and could be fundamentally flawed. This will then only become apparent in a ‘live’ situation. Product recall/withdrawal tests should be documented and records retained. Corrective action identified as a result of non‐compliance during a test must be verified to ensure that it has been implemented and has been effective.

27.12 The length of time for a product withdrawal/recall test between initiation and completion should also be recorded to ensure that a potential withdrawal/recall would be carried out in an appropriate timescale.

27.13 The procedures and documentation should be reviewed regularly to check whether there is a need for revision in the light of changes in circumstances, resources or who is deemed to be the responsible person. This could include changes to telephone numbers, contact details or specific customer procedures such as an amendment for the time limit for notification.

27.14 Product withdrawals or recalls may arise in a variety of circumstances, which fall into three main categories:

1. where the food enforcement authorities become aware of a hazard or suspected hazard, and information and cooperation from the manufacturer or importer is necessitated;
2. where the manufacturer, importer, distributor, retailer or caterer becomes aware of a hazard or suspected hazard;
3. where there is no hazard or suspected hazard involved, but there is some circumstance (e.g. substandard quality, mislabelling) that has come to light and that prompts the manufacturer, importer or retailer to decide to withdraw or recall the affected product.

In case (c), the company will itself have to organise the withdrawal or recall operation. In cases (a) and (b), consideration may be given to issuing a public food hazard warning. Generally, this would be done in consultation with the manufacturer or importer, the distributor or retailer, and any relevant enforcement authority interest. The UK FSA issues Allergy Alerts and Food Alerts based on recalls from the retail stage of the supply chain. The FSA issues a Product Withdrawal Information Notice or a Product Recall Information Notice to let the general public, the food supply chain and local authorities know about problems associated with food. A Food Alert for Action is issued where formal intervention by enforcement authorities is required. Normally any arrangements for recall would be discussed so that the most appropriate methods could be effected or endorsed by the relevant authorities, and would also take into account any requirements for or arising from the information indicated below.

27.15 Although a defect or a suspected defect leading to withdrawal or recall may have come to light in respect of a particular batch or batches or a particular period of production, urgent consideration should be given to whether other batches or periods may have also been affected (e.g. through use of a faulty material, or a plant or processing fault) and whether these should also be included in the withdrawal/recall.

27.16 The procedures should lay down precise methods for notifying and implementing a withdrawal or recall from all distribution channels, retailers and goods in transit, that is, wherever the affected product might be. It should also include a procedure to prevent any further distribution of affected goods. The recall procedure should also provide for the method of public notification.

27.17 Notification of withdrawal/recall should include the following information:

1. name, pack size and adequate description of the product;
2. identifying marks of the batch(es) concerned;
3. the nature of the defect;
4. action required, with an indication of the degree of urgency involved.

27.18 Recalled or withdrawn material should be quarantined pending a decision as to appropriate treatment or disposal.

Emergency Procedure

27.19 Regrettably the possibility of threats arising from the actions of second or third parties must be faced, for example deliberate contamination or poisoning of product or ingredient by terrorists, extremists or otherwise misguided persons (see 5.4, 6.3 and 9.21). Although some of the additional action that might be taken in such circumstances could be considered outside the scope of this Guide, it is included because those concerned in the manufacturing operation would very probably become involved in product incident assessment and, if required, isolation, withdrawal and/or a full recall.

27.20 The first intimation of a problem in this area could come from a whole variety of sources, for example a consumer complaint, the retailer, the media, the police, the enforcement authorities, employees or by telephone, email or texting, post or personal contact with any company location or any employee at any time.

27.21 It is therefore essential that any personnel engaged in manufacture should be aware of company procedures to be followed in dealing with such threats both within and outside of normal working hours, and that suitable arrangements exist for calling in key personnel out of hours in such an emergency. The extent to which any such emergency procedures may override normal lines of management should be explicitly stated. These procedures should be formally documented (see Chapter 6).

27.22 Faced with an emergency situation, the withdrawal/recall procedures described above will apply, while the expertise of those involved in quality control and other relevant functions should be put at the disposal of the crisis management team responsible for handling the emergency.

27.23 The possibility of such sabotage, vandalism, terrorism and even site invasion may indicate a need for particular security precautions in vulnerable areas, for example entrance security, closed‐circuit television (CCTV) security, code pads to open external doors to manufacturing areas, locked rooms and the use of tamper‐evident or other type of security seals to safeguard raw materials and finished product during storage or transfer (see 9.21).

27.24 Any emergency or recall situation is likely to involve retailers, wholesalers and/or food service, and a smooth and effective interface with their procedures should be achieved as early as possible during the crisis.

27.25 The risk of harm from the actions of both current and previous employees needs to be formally addressed by the manufacturer, including consideration of the need for pre‐employment screening and employment termination interviews and protocols.

Business Continuity Management

27.26 An important element of GMP is maintaining the continuity of supply in the event that an incident occurs that disrupts ‘normal’ manufacturing activity. The business operator should have developed written continuity plan(s) to identify the impact of specific incidents and what actions would be taken in the event that they occurred. Malicious damage and sabotage have been previously addressed in this chapter but the following should also be considered:

• natural disaster, for example flooding, earthquake, hurricane or other weather event;
• environmental release, for example refrigerant, gas or failure in temperature control equipment or as a result of fire on the premises; and
• disruption of major services, including water, energy, transport and logistics, communications, for example Internet and telephone, or staff availability, including a disease or food safety outbreak in the wider population.

27.27 The PAS 96:2017 Guide to protecting and defending food and drink from deliberate attack identifies steps that need to be taken to develop food protection and defence procedures and an associated emergency response and business continuity management system (BCMS) to ensure that the business can effectively manage a potential incident (see 5.6). Business continuity plans are an important element of the manufacturer’s formal management systems. They could be situated within the QMS, FSMS or the FIMS. BS 11200:2014 Crisis management. Guidance and good practice gives guidance to help plan, establish, operate, maintain, monitor, verify and review a organisation’s crisis management plan and its wider capability.

ISO 22313: 2014 Societal Security – Business continuity management systems – Guidance identifies the requirements for setting up and managing an effective BCMS that aligns with recognised best practice. ISO 22316:2017 Security and resilience: Organisational resilience – Principles and attributes provides guidance on resilience, i.e. being able as a manufacturing organisation to anticipate and respond to potential threats and opportunities and adapt to risk and the changing environment in which the business operates. A resilient business can absorb and adapt to supply chain and market shocks and still meet its organisational objectives.