Quality Management Systems for the Food Industry

Transcription

1 Quality Management Systems for the Food Industry

2 Quality Management Systems for the Food Industry A guide to ISO 9001/2 Andrew Bolton Quality Management Consultant Tunbridge Wells, UK A Chapman & Hall Food Science Book An Aspen Publication Aspen Publishers, Inc. Gaithersburg, Maryland 1999

3 The author has made every effort to ensure the accuracy of the information herein. However, appropriate information sources should be consulted, especially for new or unfamiliar procedures. It is the responsibility of every practitioner to evaluate the appropriateness of a particular opinion in in the context of actual clinical situations and with due considerations to new developments. The author, editors, and the publisher cannot be held responsible for any typographical or other errors found in this book. Aspen Publishers, Inc., is not affiliated with the American Society of Parenteral and Enteral Nutrition. Originally published: New York: Chapman & Hall, Includes bibliographical references and index. (Formerly published by Chapman & Hall, ISBN ) ISBN CIP Copyright 1997, 1999 by Aspen Publishers, Inc. All rights reserved. Aspen Publishers, Inc., grants permission for photocopying for limited personal or internal use. This consent does not extend to other kinds of copying, such as copying for general distribution, for advertising or promotional purposes, for creating new collective works, or for resale. For information, address Aspen Publishers, Inc., Permissions Department, 200 Orchard Ridge Drive, Suite 200, Gaithersburg, Maryland Orders: (800) Customer Service: (800) About Aspen Publishers For more than 35 years, Aspen has been a leading professional publisher in a variety of disciplines. Aspen's vast information resources are available in both print and electronic formats. We are committed to providing the highest quality information available in the most appropriate format for our customers. Visit Aspen's Internet site for more information resources, directories, articles, and a searchable version of Aspen's full catalog, including the most recent publications: Aspen Publishers, Inc. The hallmark of quality in publishing Member of the worldwide Wolters Kluwer group Editorial Services: Ruth Bloom Library of Congress Catalog Card Number: 9 6 ~ ISBN: I

4 Contents Preface Acknowledgements ix xi 1 Introduction Introduction The Food Safety Act The statutory defences - Due Diligence What is BS EN ISO 9001? Summary 5 2 Quality management principles - why BS EN ISO 9001? Quality management principles What is BS EN ISO 9001? Results and benefits The administration of BS EN ISO Summary 12 3 Preparation for the programme - management commitment Strategic objective and scope Is it the right time? Management commitment and understanding Management Representative A consultant or not? Appointment of assessors Project costs Project plan and timescale Summary 18 v

5 Contents 4 Management responsibility Introduction Quality policy Responsibility and authority Management Representative Management review Complaint management Summary 23 5 The quality system and document control Introduction The quality policy statement The quality manual and procedures The quality plan The document system Management of documentation Computer access and security Summary 40 6 Buying and selling - purchasing and contract review Introduction Purchasing Contract review Summary 46 7 Design and development Introduction Project plan Project management plan Design documentation Design specifications Summary 54 8 Process control Introduction Planning Specification and controls Dress and hygiene Special processes Cleaning Nonconforming product Work in progress Waste management Customer-supplied product 60 vi

6 Contents 8.11 Handling, storage, packaging, preservation and delivery Product identification and traceability Pest control Corrective and preventive action Production trials Quality records Summary 64 9 Inspection, measuring and testing - calibration Introduction Inspection and testing Control of inspection, measuring and test equipment - calibration Inspection and test status Summary Internal quality audit Introduction Internal audit procedure The audit schedule Selection and training of auditors Preparation of the auditees The internal audit training programme Company awareness Summary Training Introduction Induction training Job descriptions/work instructions General training Personal records Summary The assessment process Introduction Appointment of assessors Document review The assessment Surveillance visits Summary Achievement of the standard - what next? Introduction 101 vii

7 Contents 13.2 Total quality management Performance indices and quality costs Quality improvement teams and quality circles Quality tools The cult of continuous improvement Other accreditation/certification systems Introduction Industry schemes National and international schemes Guidelines and codes of practice Codex Alimentarius Confidence marks Distributors' own brands and contracts In conclusion Contact addresses 112 Appendix A Model quality manual: QFS Quality Food Services 113 Appendix B Accredited third-party certification bodies 145 Appendix C Guidance notes for the application of BS EN ISO 9001: 1994 for the food and drink industry 147 Appendix D Guidance notes for the application of ISO 9002/EN29002/BS 5750: Part 2 To the hotel and catering industry Appendix E New Zealand Q-Base code: quality management systems for small and medium-sized enterprises - general requirements TB 004:1995 Appendix F Glossary References Index viii

8 Preface In recent years there has been growing pressure for consistent product quality, and a need for companies to demonstrate sound quality management practices in order to meet 'Due Diligence' requirements of both legislation and the quality assurance practices of customers. It has become accepted that operating to the requirements of the international standard for quality management - BS EN ISO goes a long way towards meeting these needs. The objective of this book is to explain the requirements of the standard, to offer advice about achieving those requirements and to indicate what the assessors will look for at assessment time. It is important that certification to the standard is sought to support achievement of company objectives and not the reverse, and of course the standard can apply to organizations and services, just as much as to companies. Thus the word' company' in the text should be treated accordingly. lllustrative material has been presented under the logo of a fictitious company 'Quality Food Services' - in this context QFS does not bear any relationship whatsoever to any identically or similarly named business that may exist. Readers will find it helpful to read the book with a copy of the standard to hand, and are strongly encouraged to read the complete text before taking any steps to prepare for certification to the standard. Andrew Bolton Tunbridge Wells June 1996 ix