Food and Drink - Good Manufacturing Practice

A Guide to its Responsible Management

Louise Manning

• Publisher: Wiley-Blackwell
• Year: 2012
• Print ISBN: 9781118318201
• eBook ISBN: 9781118318232
• Edition: 6
• Topic: Technology & Engineering
• Subtopic: Food Science
• Index: Technology & Engineering

Good Manufacturing Practice (GMP) refers to advice and guidance put in place to outline the aspects of production and testing that can impact the quality and safety of a product. In the case of food and drink, GMP is aimed at ensuring that products are safe for the consumer and are consistently manufactured to a quality appropriate to their intended use. Manufacturers have for several years been driving towards such goals as Total Quality Management (TQM), lean manufacturing and sustainability – GMP is bound up with these issues. The ever-increasing interest amongst consumers, retailers and enforcement authorities in the conditions and practices in food manufacture and distribution, increases the need for the food manufacturer to operate within clearly defined policies such as those laid down in GMP. The ability to demonstrate that Good Manufacturing Practice has been fully and effectively implemented could, in the event of a consumer complaint or a legal action, reduce the manufacturer's liability and protect them from prosecution.

First launched in 1986, IFST's Good Manufacturing Practice Guide has been widely recognized as an indispensable reference work for food scientists and technologists. It sets out to ensure that food manufacturing processes deliver products that are uniform in quality, free from defects and contamination, and as safe as it is humanly possible to make them. This 6^th edition has been completely revised and updated to include all the latest standards and guidance, especially with regard to legislation-driven areas such as HACCP.

The Guide is a must have for anyone in a managerial or technical capacity concerned with the manufacture, storage and distribution of food and drink. It is also a valuable reference for food education, training and for those involved in food safety and enforcement. Food scientists in academic and industry environments will value its precision, and policy makers and regulatory organizations will find it an indispensable guide to an important and multifaceted area.

About IFST

IFST is the leading independent qualifying body for food professionals in Europe and the only professional body in the UK concerned with all aspects of food science and technology. IFST members are drawn from all over the world and from all ages and backgrounds, including industry (manufacturing, retailing and food service), universities and schools, government, research and development, quality assurance and food law enforcement. IFST qualifications are internationally recognised as a sign of proficiency and integrity.

PART I – GENERAL GUIDANCE

1

INTRODUCTION

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 catering and vending industries, it does not deal with catering and retail activities per se. The Guide is therefore particularly concerned with advice to management on:

• matters affecting product safety, including health and hygiene of personnel relating thereto;
• product manufacture in terms of product and process control and handling under hygienic conditions in conformity with product, packaging and labelling specifications; and
• associated 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 on principles, 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 product safety and integrity. In general it does not deal with matters unrelated to scientific, technological and organisational aspects affecting product quality and safety.

1.4

EU Regulation (EC) 853/2004, laying down specific hygiene rules for the hygiene of foodstuffs, requires Approval of any establishment producing foods of animal origin. Any change in production may affect the status of such Approval. This includes (although not exclusively so) changes to product range and to product descriptions, changes in the production process, changes in equipment and in establishment design and layout. In such cases re-approval may be required and FBO’s should contact their Local Food Authority.

The Leading case Allan Rich Seafoods v. Lincoln Magistrates’ Court [2009] EWHC 3391 confirmed that changes in the Food Business Operator (FBO) also require re-approval of such an establishment.

Any change in production may affect the status of Approval under Regulation (EC) 853/2004. This includes (although not exclusively so) changes to product range and to product descriptions, changes in the production process, changes in equipment and in establishment design and layout. In such cases re-approval may be required and FBO’s should contact their Local Food Authority.

1.5

The Guide will also make reference to international standards such as those developed by the Codex Alimentarius Commission. It is then the responsibility of the reader to refer to current legislation itself or review with the support of a competent adviser, and not to rely on an interpretation or an abridged version of the requirements as given in this document.

In addition to mandatory legal requirements, the Guide is concerned with advisable practices some of which may already be contained in published guidelines or codes of practice. The Guide outlines general principles and gives references that the reader is advised to consult in full.

1.6

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 Food Safety Act 1990, and other subsequent legislation such as the General Food Regulations 2004 and the Food Hygiene Regulations 2006, a manufacturer, retailer or importer charged with an offence may enter the legal defence that (s)/he ‘took all reasonable precautions and exercised all due diligence to avoid the commission of the offence by himself or by a person under his control’. In this context, it can be considered that ‘precautions’ are the measures taken and ‘diligence’ 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 ‘all’ implies that ‘some’ or ‘most’ will not be enough. What constitutes ‘all reasonable precautions and all due diligence’ 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 ‘nature, substance or quality’ 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 (GMP) will stand a very good chance of 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.

1.7

Responsibility for enforcement within the EU varies from country to country. In the UK it is shared between central and local government bodies. While the making of legislation in the UK is the function of central 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 environmental health officers (EHOs) and trading standards officers (TSOs).

The responsibilities of all the enforcement authorities in the UK are set out in the Single Integrated National Control Plan for the UK; this demonstrates the complexity of structures of enforcement across the UK, and the paragraphs below are a broad overview for those in food manufacturing and arrangements may be different within your geographical area or industry sector.

The Food Standards Agency (FSA) interaction with enforcement officers is set out in the Framework Agreement on Local Authority Enforcement. This document gives a structure to the Agency’s supervision of LA enforcement work.

The Food Law Code of Practice (FLCP) sets out the way LAs should apply food law, and how they should work with food businesses. Practical guidance is also provided as a further help to enforcement officers.

The EHOs and TSOs have to be authorised by their LAs to enforce the food legislation. Once they achieve certain qualifications, detailed under the FLCP, they are authorised to carry out certain tasks and are provided with powers (under the Food Safety Act 1990) to, for example, enter premises, take samples, gather evidence, issue notices and, under certain circumstances, close premises.

Depending on the structure of the Local Government in the area in England and Wales, food visits may be from TSOs to examine labelling, compositional standards and food contaminants, and EHOs to check on food hygiene; however in Scotland, Northern Ireland and some Welsh and English authorities, EHOs are responsible for all the food legislation with TSOs responsible for weights and measures checks. Visits to manufacturing sites are to ensure compliance with legislation; the frequency of interventions (visits) is assessed according to the risk assessment system detailed in the FLCP, and most manufacturing units can expect a visit at least once a year.

The actual policy and resources allocated to the inspection premises and sampling of product will depend on the LA and therefore there are variations in delivery. However businesses should be able to benefit from a positive relationship with enforcement authorities receiving detailed written feedback following inspections and receive results of sampling exercises. Companies who develop a ‘Home Authority’ or ‘Primary Authority’ agreement with their LAs can expect a more detailed and possibly, a more supportive relationship with the benefits of the Better Regulation agenda.

1.8

Absolute terms, such as ‘ensure that’, ‘avoid’, ‘prevent’, ‘absence of … ’ 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, ‘ensure that … ’ should be read as meaning ‘ensure, so far as is reasonably practicable, that … ’. Words such as ‘should’ are used for non-mandatory advice, and the imperative, for example, ‘must’ or ‘shall’ is reserved for appropriate mandatory requirements.

1.9

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.

1.10

The Guide is an advisory document with a list of supplementary references intended to assist all grades of management. It 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.

1.11

GMP is not a static concept, but an evolutionary, dynamic mechanism by which overall improvements can be made and maintained.

1.12

Abbreviations, for example, GMP, have been used in the text but have been reconfirmed at the start of each chapter in case the chapter is read in isolation and therefore to minimise the number of times that the reader has to refer to the abbreviations list (Appendix II).

2

QUALITY MANAGEMENT SYSTEM

Principle

There should be a comprehensive quality management system (QMS), so designed, documented, implemented, reviewed and continuously improved, and so furnished with personnel, equipment and resources, as to ensure that specifications set to achieve the intended product quality standards are consistently met. The attainment of this quality objective requires the involvement and commitment of all concerned at all stages of manufacture.

Explanatory Note

2.1

A manufacturer has to comply with the legal requirements relevant to the product manufactured. While embracing these, (s)/he will have determined the market requirement that (s)/he aims to meet, and therefore t...

Table of contents

• Cover
• Title page
• Copyright page
• Foreword
• Acknowledgements
• Preface to the Sixth Edition
• Preface to the Fifth Edition
• Preface to the Fourth Edition
• Preface to the Third Edition
• Preface to the Second Edition
• Decision Makers’ Summary
• PART I – GENERAL GUIDANCE
• PART II – SUPPLEMENTARY GUIDANCE ON SOME SPECIFIC PRODUCTION CATEGORIES
• PART III – MECHANISMS FOR REVIEW OF THIS GUIDE