Microbiological Analysis of Food and Water: Guidelines for Quality Assurance This Page Intentionally Left Blank Microbiological Analysis of Food and Water: Guidelines for Quality Assurance Edited by N.F. Lightfoot Public Health Laboratory Service Newcastle upon Tyne U.K. E.A. Maier European Commission DG XII Measurement and Testing Programme Brussels Belgium ELSEVIER AmsTerdam - Boston - London - New York - Oxford - Paris San Diego - San Francisco - Singapore - Sydney - Tokyo ELSEVIER SCIENCE B.V. Sara Burgerhartstraat 25 P.O. Box 211, 1000 AE Amsterdam, The Netherlands © 1998 Elsevier Science B.V. All rights reserved. This work is protected under copyright by Elsevier Science, and the following terms and conditions apply to its use: Photocopying Single photocopies of single chapters may be made for personal use as allowed by national copyright laws. 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First edition (hardbound) 1998; Second impression 1999; Third impression 2003 Paperback edition 1999; Second impression 2003 Library of Congress Cataloging-in-Publication Data Microbiological analysis of food and water : guidelines for quality Assurance / edited by N.F. Lightfoot, E. A Maier. p. cm. Includes bibliographical references and index. ISBN 0-444-82911-3 (hardcover : alk. Paper) ~ ISBN 0-444-50203-3 (pbk. : alk. Paper) I. Food-Microbiology. 2. Water-Microbiology. 3. Food industry and trade-Quality control. 4. Water quality. 1. Lightfoot, N. F. O^igel F.), 1945- II. Maier, E. A. QR115.M46 1998 664'.00r579-dc21 98-13035 CIP ISBN: 0-444-82911-3 (hardcover) ISBN: 0-444-50203-3 (paperback) @ The paper used in this publication meets the requirements of ANSI/NISO Z39.48-1992 (Permanence of Paper). Printed in The Netherlands. Preface In 1986, the European Commission began to support research and development activities in the field of microbiological measurements. Within the BCR (Community Bureau of Reference), and later within the Measurement and Testing Programme (M & T Programme), sev eral projects were launched which covered various aspects of food and water microbiology. The main objectives of these projects were to develop adequate tools for the validation of microbiological measurement and testing methods. Two projects — food and water microbiology — included the development of representative and stable reference materials, and involved more than one hundred laboratories from the European Union in interlaboratory studies. Fundamental research on the behaviour of microbes in spray-dried milk powder was undertaken. Measurement methods and statistical treatment tools were devel oped to assess the homogeneity and stability of these reference mate rials, and the results led to the development of several reference materials used in European-wide interlaboratory studies. Several bacterial strains were studied in food (salmonella, listeria, B. cereus, S. aureus, C. perfringens, E. coli) and water (E. faecium, E. cloacae, E. coli, salmonella and C. perfringens). For each of the studied microbes, several methods of measurement or testing were com pared. Quality assurance (QA) and quality control (QC) items have been developed. The major achievements of these projects were: (i) the production and validation of several standard operating procedures for basic components of microbiological testing or measurement methods (e.g., measurement of pH of culture media, measurement of temperature in incubators, etc): vi Preface (ii) the development and validation of working tools for the proper organization of interlaboratory studies (transport of samples, analj^ical protocols, etc) and statistical treatment of the results; (iii) the production and certification of six reference materials. In addition to these two projects, the Commission has also sup ported a study on the determination of faecal contamination of sea- water. As the stability of microbes and the sea-water matrix could not be guaranteed in a large-scale interlaboratory study (instability during transport), the evaluation of the methods was organized in one central laboratory where the participants applied their own methods to common sea-water samples. Finally, research projects on the development and validation of new, rapid microbiological measurement methods were also sup ported by the Measurement and Testing Programme. Within these projects, discussions revealed the necessity of devel oping several important procedures for proper quality assurance and quality control systems in microbiological laboratories. Many of these missing procedures were already known in other fields of meas urement sciences, but had not been used in microbiology. Some QA and QC principles and tools were already known, but were not read ily available to all microbiologists. Finally, the knowledge developed in the projects by the participating laboratories needed to be made available to all testing laboratories through the development of a complete set of guidelines. The importance of these guidelines was reinforced by the implementation of national accreditation systems and their mutual recognition within the European Union following the resolution (90/Cl/Ol of 21 December 1989) of the European Council on the 'global approach to conformity assessment'. The accreditation systems are based on European Standard EN 45001, which lists several requirements to be fulfilled by laboratories. Sev eral procedures (e.g., statistical control, use of reference materials, validation of methods, proficiency testing, etc.) are still not used by microbiologists, and need to be translated into microbiological terms or adapted to the particular situation of microbiological measure ments or testing. Some participants in previous BCR projects recognized the impor tance of the task. With the help of other leading QA and QC Preface vii microbiology specialists in Europe, they decided to prepare a com plete set of guidelines on how to start and implement a quality sys tem in a microbiological laboratory. This project has been supported by the Commission through the Measurement and Testing Programme. The working group included food and water microbiologists from various testing laboratories, universities and industry, as well as statisticians and QA and QC specialists in chemistry. This book represents the outcome of their work. It has been writ ten with the express objective of using simple but accurate wording, to be accessible to all microbiology laboratory staff. To facilitate read ing, the more specialized items, in particular some statistical treat ments, have been added as an annex to the book. All QA and QC tools mentioned within these guidelines have been developed and applied by the authors in their own laboratories. All aspects dealing with ref erence materials and interlaboratory studies have been taken in a large part from the projects conducted within the BCR and M & T programmes of the European Commission. The European Commission and the editors wish to express their sincere thanks to the authors of these guidelines for their tremen dous effort. Thanks are also due to the participants and organizers of the former microbiology projects of the Commission, who produced the basic information and materials on which several aspects and conclusions of these guidelines are based. It is appreciated that with so many different quality control proce dures, their introduction in a laboratory would appear to be a formi dable task. The authors recognize that each laboratory manager will choose the most appropriate procedures, depending on the type and size of the laboratory in question. Accreditation bodies will not expect the introduction of all measures, only those that are appropri ate for a particular laboratory. N.F. Lightfoot Newcastle E.A. Maier Brussels This Page Intentionally Left Blank List of contributors N.F. Lightfoot Public Health Laboratory Service, Newcastle upon Tyne, U.K. E.A. Maier European Commission, DG XII Measurement and Testing Programme, Brussels, Belgium H. Beckers Unilever Research Laboratory, Vlaardingen, Netherlands S. Dahms Institut fur Biometrie der freien Universitdt Berlin, Berlin, Germany J.M. Delattre Institut Pasteur de Lille, Lille, France A. Havelaar National Research Institute of Public Health & Environmental Protection (RFVM), Bilthoven, Netherlands M. Michels Unilever Research Laboratory, Vlaardingen, Netherlands S. Niemela University of Helsinki, Helsinki, Finland J. Papadakis Athens School of Hygiene, Athens, Greece D. Roberts Food Hygiene Reference Laboratory, Central Public Health Laboratory, London, U.K. H. Tillett Communicable Disease Surveillance Centre, Public Health Laboratory Service Board, London, U.K. H.R. Veenendaal KIWA NV, Nieuwegein, Netherlands H. Weiss Institut fur Biometrie der freien Universitdt Berlin, Berlin, Germany
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