1.1 The purpose of this Guide is to outline the responsibilities of managers in relation to the efficient manufacture and control of food and drink products, thereby ensuring that such products are safe, wholesome and of the nature and quality intended. While it addresses manufacture of food and drink for use in the retail, catering and vending industries, it does not deal with catering and retail activities per se. The Guide is therefore particularly concerned with management practices associated with:
- factors affecting product safety, product legality, product integrity and product quality;
- product manufacture in terms of product and process control and handling of food under hygienic conditions in conformity with product, packaging and labelling specifications; and
- matters such as training of personnel, documentation and record keeping, supplier approval, suitability of premises and equipment and site standards, waste avoidance, recovery and reworking of materials, laboratory management, traceability, verification activities, and preventive and corrective action and the management of customer complaints and product recall.
1.2 It is emphasised that the Guide is concerned with advice based on principles of good manufacturing practice (GMP), and it is recognised that methods other than those described, but which achieve the same ends, may be equally acceptable. Personnel and premises hygiene, because of its importance, is treated as a continuous theme and a subject for consideration throughout the document.
The Guide is in three parts:
- Part I: deals with matters of general application;
- Part II: deals with guidance on specific manufacturing and/or food categories; and
- Part III: covers mechanisms for review of the Guide.
1.3 The Guide does not deal directly with such matters as operative safety and welfare, ethical matters, animal welfare or environmental issues including water and energy conservation. It refers to resource management and waste control, engineering, maintenance and transport and distribution only in respect of those aspects that have a bearing on manufacturing practices. In general it does not deal with matters unrelated to scientific, technological and organisational aspects affecting product safety, product legality, product integrity and product quality.
1.4 The Guide has been written at a time when the United Kingdom (UK) is negotiating a new relationship with the European Union (EU) in terms of legislative harmonisation and trade agreements. To this end legislation still in force at the time of writing has been referenced, but may change post publication of this Guide. This is true of any legislation and/or policy approach in a given country or trading group when referenced by a static publication. The principles of GMP are universal and in many ways transcend the specifics of one nationās current or emerging legislation. Food manufacturers supplying internationally need to be aware of not only the legislation in the country in which they are manufacturing, but also the need for the products produced to comply with the legislation in countries to which they seek to export. There are many instances of product recalls in countries as a result of food products, for example, not complying with the export countriesā requirements for food allergen labelling for ingredients such as celery, mustard or milk. It is the responsibility of the reader to refer to current legislation itself or review the contents of this Guide with the support of a competent adviser, and not to rely on an interpretation or an abridged version of legislative requirements as given in this document.
1.5 Absolute terms, such as āensure thatā, āavoidā, āpreventā, āabsence ofā and so on, have been used in various parts of the Guide. To dispense with them would detract from the intentions of the Guide or would necessitate lengthy explanations on each occasion. Accordingly, readers should note that such terms are to be interpreted in a rational and practical way, for example āensure thatā should be read as meaning āensure, so far as is reasonably practicable, thatā. Words such as āshouldā are used for nonāmandatory advice, and the imperative, for example āmustā or āshallā, is reserved for appropriate mandatory requirements.
1.6 Definitions of some of the terms used in this Guide are given in Appendix I. It is appreciated that other definitions may be equally valid or preferred, and the appendix definitions are simply intended to clarify the meanings attributed to a word or phrase when used in the compilation of the Guide.
1.7 The Guide is an advisory document with a list of supporting, supplementary references. The Guide may be particularly useful to students studying food manufacture, to new entrants to management and to general managers in smaller companies who may be responsible for a range of management functions, each of which may be the sole concern of one or more specialist senior managers in a larger company as well as regulatory officers.
1.8 GMP is not a static concept, but an evolutionary, dynamic mechanism by which overall improvements in manufacturing controls can be developed, implemented and maintained.
1.9 The Guide outlines general principles that may already be contained in published guidelines or codes of practice. As appropriate, the Guide will provide references to the original sources that the reader is then advised to consult in full. The Guide will also make reference, where appropriate, to international private standards such as those developed by the Codex Alimentarius Commission.
1.10 The initial adoption of the EC Official Control of Foodstuffs Directive and the advent of the UK Food Safety Act 1990 as well as existing provisions of the UK Trade Descriptions Act and the UK Weights and Measures Act gave increasing emphasis to the need for a manufacturer to be able to prove that (s)/he did everything necessary to comply with the law. Thus under the UK Food Safety Act 1990, and other subsequent legislation, a manufacturer, retailer or importer charged with an offence may enter the legal defence that (s)/he ātook all reasonable precautions and exercised all due diligence to avoid the commission of the offence by the accused or by a person under the control of the accusedā. In this context, it can be considered that āprecautionsā are the measures taken and ādiligenceā is the activities undertaken to ensure their effective application. The wording puts the onus of proof on the defendant, and both must be proved and the use of the word āallā implies that āsomeā or āmostā will not be enough. What constitutes āall reasonable precautions and all due diligenceā in a particular instance must relate to the nature of the offence and to other related circumstances. Nevertheless in the case of a safety or a ānature, substance or qualityā offence, a manufacturer who can prove that (s)/he has diligently installed and appropriately applied all the relevant measures in the Institute of Food Science & Technology (IFST) Guide to Good Manufacturing Practice will stand a very good chance of having a successful defence. It must also be pointed out that a manufacturer who does not employ appropriate technically competent personnel to specify the product formulation, factory processes and procedures to design and control the continuous monitoring of their correct operation and undertake such validation and verification activities cannot be said to have exercised either adequate precautions or adequate diligence and is unlikely to have a successful defence.
1.11 Responsibility for enforcement within the EU varies from country to country. In the UK it is shared between central, devolved and local government bodies. While the making of legislation in the UK is the function of central and devolved government, the enforcement of food law is primarily (but not solely) the responsibility of more than 400 local authorities (LAs) in the UK, and more specifically LA officers. LA officers can be differentiated as being environmental health officers (EHOs) and trading standards officers (TSOs). The Food Standards Agency (FSA) has a statutory requirement, in consort with other government bodies, to protect public health and consumersā interests in relation to food. Since the publication of the last version of the GMP Guide (Version 6) there has been a policy review with regard to food regulation to move to a more riskābased approach. A riskābased approach is well established in UK food regulation, for example the food establishment intervention rating schemes. This trend is also considering the use of public and private regulatory activities to develop a form of coāregulation. This would include utilisation of information from both public enforcement activities (e.g. EHO inspections) and information from private surveillance and verification activities such as thirdāparty audits and product sampling activities.
The roles and responsibilities of all the authorities and organisations in the UK involved in monitoring compliance with, and enforcement of, feed and food law, plant health and feed and food law are set out in the MultiāAnnual National Control Plan (MANCP) for the UK. It is a requirement of Regulation (EC) No. 882/2004 that all EU member states have such a national control plan in place. The MANCP is produced jointly by the FSA and the Department for Food and Rural Affairs (Defra), with contributions from national and devolved agencies. The paragraphs below are a broad overview of the UK legislative framework relating to food manufacture and specific arrangements may be different within a geographical area or industry sector so this should be considered when reading this Guide.
The Framework Agreement on Official Feed and Food Controls by LAs provides the FSA with the processes required to implement its powers under the Food Standards Act 1999. This agreement gives structure to the FSAās su...