Igor Renato Bertoni Olivares
Laboratory
Quality Management Translated from Portuguese by Beverly Victoria Young
GENERAL DIRECTOR Wilon Mazalla Jr. EDITORIAL COORDINATION Marídia R. Lima REVIEW AND COORDINATION COPYDESK Catarina C. Costa DESKTOP PUBLISHING Fabio Diego da Silva Tatiane de Lima COVER Leonardo Paiva Cataloguing in-Publication Data (CIP) (Câmara Brasileira do Livro, SP, Brasil) Olivares, Igor Renato Bertoni Laboratory quality management / Igor Renato Bertoni Olivares. - Campinas, SP: Editora Átomo, 2016. Bibliography. 1. Laboratories - Quality control I. Title. 06-0234
CDD-001.4
Scores for regular catalog: 1. Laboratory: quality management 001.4 2. Laboratory: quality systems 001.4 ISBN 978-85-7670-267-2 All rights reserved to
Grupo Átomo e Alínea Rua Tiradentes, 1053 - Guanabara - Campinas-SP CEP 13023-191 - PABX: (19) 3232.9340 e 3232.0047 www.atomoealinea.com.br Printed in Brazil
EDITORIAL BOARD Area | Chemistry Aécio Pereira Chagas Universidade Estadual de Campinas – UNICAMP
Célio Pasquini Universidade Estadual de Campinas – UNICAMP
Flávio Leite T & E Analítica
José de Alencar Simoni Universidade Estadual de Campinas – UNICAMP
Mário Sérgio Galhiane Universidade Estadual Paulista – UNESP
Pedro Faria Universidade Estadual de Campinas – UNICAMP
Robson Fernandes de Farias Universidade Federal do Rio Grande do Norte – UFRN
Considering that life is a mission accomplished through our daily experiences, if devoid of a solid foundation, after every storm it will certainly have to be rebuilt. And with a foundation based on a solid family concept, I believe that storms can be overcome and I can therefore persevere to build my own mission. So I dedicate this book to my family, and in particular to the love of my life – My wife and son. This book is also dedicated to all who at some point have participated or to some degree still participate in my life and who have contributed to my personal and professional development – either with a word, sometimes with hours of conversation or with special attitudes – and especially those I am proud to call my friends.
Contents Foreword......................................................................................................9 Introduction................................................................................................13 Chapter 1 Quality: evolution of concepts...................................................................15 Quality and quality management system – definitions........................25 Chapter 2 Why Should a Quality Management System be Implemented in a Laboratory?..............................................................27 Accreditation system of Cgcre/Inmetro...............................................28 IBAMA requirements...........................................................................32 ANA requirements................................................................................32 MAPA requirements.............................................................................33 ANVISA requirements.........................................................................35 Requirements of the São Paulo State Environment Secretariat...........37 Laboratory Quality Management Systems – implementation in university environment..........................................37 Conclusion............................................................................................40 Chapter 3 Requirements and Operation of a Laboratory Quality Management System..................................................43 Structuring the Quality Management System......................................43 Procedures and records of Quality Management System.....................46 Quality management system manual....................................................92 Conclusions..........................................................................................93
Chapter 4 Quality Indicators.......................................................................................95 Application of indicators and quality index as a tool for critical analysis and continuous improvement of laboratories accredited against ISO/IEC 17025...................................97 Chapter 5 Analytical Quality Assurance Cycle (AQAC).........................................103 Chapter 6 Types of Laboratory Quality Management Systems................................107 ISO/IEC 17025...................................................................................108 GLP....................................................................................................113 Chapter 7 Comparison Between Laboratory Quality Management Systems (GLP x ISO/IEC 17025)......121 Chapter 8 Difficulties and Advantages in Implementing a Laboratory Quality Management System......................125 References................................................................................................133
Foreword Most professionals working in large companies have to be well informed about Quality Management Systems, a prerequisite in today’s competitive market. Although there are specific systems for each area of activity, such as TS16949 (for the automotive parts industry), ISO 9001 (for companies in general), GLP, ISO/IEC17025 or ISO15189 (for laboratories), the basic structure of the system is very similar, with a work system that uses procedures, records, systems manual, even similar to the ISO 14001, which despite the fact it is an Environmental Management System, also uses this same structure. Therefore, this knowledge will provide the basis for professionals to be familiarized with the work system commonly used by companies. In Brazil, particularly with regards to Laboratory Quality Management System (LQMS), several federal agencies have pushed for (often mandatory) its implementation, especially for ANVISA (National Health Surveillance Agency), IBAMA (Brazilian Institute of the Environment and Renewable Natural Resources), ANA (National Water Agency), MAPA (Ministry of Agriculture, Livestock and Supply), and currently expanded to include the state government agencies such as SMA (Department of the Environment of the State of São Paulo). As a result, it has become a common practice and almost all laboratories use these systems, hence also pressing the professionals in this area to become familiarized with these systems, leading to a continued growth for the implementation
10 Foreword and accreditation of Laboratory Quality Management Systems, as shown in Figure F.1. 900
537
600
2005
2009
311
281
35
33
33
2011
2013
2
3
0
17
100
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264
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236 294
400
351
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Laboratories
700
771
ISO/IEC 17025 (RBC) ISO/IEC 17025 (RBLE) GLP ISO 15189
800
2016
Figure F.1.  Accredited laboratories in Brazil by different Management Systems based on INMETRO registration; the data available until January/2016 were considered for 2016 (RBC is the Brazilian Calibration Network and RBLE is the Brazilian Network of Test Laboratories).
This reality has global reach, as many countries have their own requirements with regards to their mandatory implementation of Laboratory Quality Management Systems, in order to ensure reliability of analytical results, mainly given that the effects of an analytical result can have major impacts on the environmental, pharmaceutical, forensic, clinical analysis, food areas, and so forth. The formal recognition of the implementation of a Laboratory Quality Management System, such as ISO/IEC17025 or ISO15189, is performed by the national accreditation bodies of different countries, which audit and assess these systems. In order to reach mutual recognition between the assessments of different countries, entities such as ILAC (International Laboratory Accreditation Cooperation) promote mutual recognition agreements with their Full Members. As for the entities from different countries which are ILAC members and associates, there are currently approximately 36.500 testing laboratories and 8.500 calibration laboratories which implement the system and are accredited in the Quality Management System according to the ISO/IEC 17025 standard, and also 4.500 accredited clinical laboratories in the ISO 15189 standard. According to Figure F.2 these numbers continue to grow.
Laboratories
Laboratory Quality Management 
50.000 45.000 40.000 35.000 30.000 25.000 20.000 15.000 10.000 5.000 0
Accredited calibration and testing laboratories (ISO/IEC 17025) Accredited medical testing laboratories (ISO 15189) Accredited inspection bodies (ISO/IEC 17020)
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
Figure F.2.  Accredited laboratories considering the accreditation bodies from approximately 114 countries that are ILAC members and associates (the calibration and testing laboratories according to ISO/IEC 17025, clinical analysis according to ISO 15189 and inspection bodies according to ISO/IEC 17020). It should be noted that in the last ten years the number of accredited laboratories has increased significantly.
Despite the professionals’ tangible need to fully understand Quality Management Systems when working in laboratories, it is often seen that undergraduate Chemistry courses in the areas of Pharmacy, Biology, Engineering, and other courses that prepare professionals to work in calibration or testing laboratories, often do not have specific materials on Laboratory Quality Management in their curriculum. Due to the common practice in laboratories, either public or private, independent or allocated in large companies (bearing in mind that the quality system implemented in a company also includes their laboratories), of using different types of Quality Management Systems, when a recently graduated professional enters the work market in a laboratory, he/she is faced with an unforeseen work system, one which was not covered by the university course. This causes an initial impact, one that forces the professional to adapt to this new work knowledge, which will be related to the specific Quality Management System of that Laboratory. Based on the scenario presented earlier, this book proposes to describe in a simple, clear and objective manner, a comprehensive universe on the implementation of Quality Management Systems in Laboratories, aimed at providing guidance to: those who work in a professional market
11
12 Foreword where this knowledge is required; those who already work with a Quality Management System for a specific area, but seek a more comprehensive understanding about its implementation; and especially to new professionals about to enter the professional market, and who will inevitably come across the Quality Management Systems.