Laboratory Quality/Management: A Workbook with an Eye on Accreditation

By Kenneth N. Parson

This book should be of interest to the management of all types of laboratories supporting
all types of scientifi c disciplines. Even though the scientifi c processes may be different the
overall approach to management is very similar including how technical processes should be
managed and controlled. The book addresses principal elements of laboratory management,
technical and support operations and offers several detailed how to procedures designed to
help laboratory management to establish and maintain control through a continuous low level
internal audit, (self assessment) process. This activity enables management to take prompt
corrective action, maintain control and provides the ability to measure improvement over time
toward achieving a higher, more effi cient, cost effective level of quality services to its assigned
customers. The objective of this book is to expand on the knowledge and understanding of
laboratory quality/management system process.

• Language: English
• Publisher: Xlibris US
• Release date: Dec 29, 2012
• ISBN: 9781479753963

Kenneth N. Parson

Kenneth N. Parson is a consultant in metrology management systems. He served as a principle technical representative for planning, design, start-up and operation for navy calibration facilities for Polaris through Trident missile and submarine operations. He holds a master’s degree in business administration from Pepperdine University and has extensive background in the organizational design and startup of laboratories and practical bench experience in the calibration and repair of most types of test and measuring equipment. He is an instrument-rated commercial pilot.

Book preview

Copyright © 2012 by Kenneth N. Parson.

Kenneth N. Parson

Office: [phone] e-mail [e-mail]

Library of Congress Control Number:   2012922052

ISBN:       Hardcover       978-1-4797-5395-6

                 Softcover         978-1-4797-5394-9

                 Ebook               978-1-4797-5396-3

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Contents

Preface

Acknowledgments

Contributions

Disclaimer

Chapter 1 Scope

Chapter 2 References

Chapter 3 Terms and Definitions

Chapter 4 Document Hierarchy

Chapter 5 Quality Manual

Chapter 6 Purpose of the Quality Manual

Chapter 7 Getting Started

Chapter 8 How to Prepare a Quality Manual

Chapter 9 Administrative Elements

Organization

Management system

Documentation

Contracting

Procurement—Services and Supplies

Customer Relations

Complaints

Nonconformity

Corrective Action

Preventive Action

Improvement

Records Management

Internal Audit

Management Review (Strategic Planning)

Chapter 10 Technical Operations

Introduction (General)

Personnel

Facilities

Methods

Equipment

Measurement Traceability

Sampling

Transportation and Handling

Outgoing Product Quality

Final Reports

Conclusion

About the Author

Subject Matter Index

To my wife Joanna and our children–

Phil, Gary, Ray and Teri

To those individuals who operate laboratories. To the management and staff of organizations who have committed the resources, time, and effort needed to improve on their methods for laboratory operation.

Preface

To develop, document, and implement a well-designed management system for laboratories is one of the most difficult and frustrating activities that can be undertaken by management. There has not been much information available on how one might approach such an effort.

This book should be of interest to the management of all types of laboratories supporting all types of scientific disciplines. Even though the scientific processes may be different, the overall approach to management is very similar, including how technical processes should be managed and controlled. The book addresses principal elements of laboratory management, technical and support operations, and offers several detailed how-to procedures designed to help laboratory management maintain control through a continuous low-level internal-audit (self assessment) process. This activity enables management to take prompt corrective action, maintain control, and provides the ability to measure improvement over time toward achieving a higher, more efficient, cost-effective level of quality services to its assigned customers.

The objective of this book is to expand on the knowledge and understanding of the laboratory management process. It should be helpful to those laboratories considering accreditation, those accredited, and those simply interested in improving on their management processes and methods of operation.

Acknowledgments

Much of the knowledge I have gained over the years has been acquired through my association with many distinguished organizations and individuals within the fields of management, quality assurance, and the design, set-up, and operation of laboratories. Some of the more significant activity that has influenced my way of thinking and approach to management was gained working with the following:

Contributions

To John Lange—thanks for all your help in the way of technical review, commentary, and for the suggestions offered during my development of this work. Your input has been most helpful.

Disclaimer

The commentary provided in this book does not, in any way, imply that incorporating any of the procedures or tools described herein will guarantee a laboratory can gain accreditation or, for that matter, that laboratory management would care to pursue such an effort.

The discussions that follow and the thoughts and ideas presented herein are solely those of the author. There is no official position by any organization on the material presented. It is simply derived by the author through years of experience, comments and advice by many associates, and observations on how well some things have worked in laboratories while other practices did not.

Chapter 1

Scope

(About Laboratories)

1.1. Laboratories provide a unique service. They (a) measure things, (b) quantify results, and (c) document and issue reports. They calibrate, test, sample, and evaluate all types of measurement phenomenon and materials and quantify results for the good of those being served. Written results and conclusions derived by the work of laboratories can be critical to the development and operational performance of products and services. Because of the highly technical nature and specialized work performed and dependence on the integrity of documented results, it is extremely important that laboratories be designed, developed, managed, and operated in such a way as to consistently achieve and document results that are above reproach. Results produced by laboratories must be clear, concise, and must provide error-free calculations and fully documented results. Even the smallest mistakes in a report can lead to a lack of confidence and trust in the results provided by a laboratory. This level of performance can only be achieved by personnel with the highest level of technical knowledge, skills, and verifiable competence. Laboratory operations are complex and unique to the work they perform.

Chapter 2

References

2.1. The following are references that would be very helpful to those actively involved in laboratory management and operations. Latest editions should be referred to.

2.1.1. International Standard—ISO 9001:2000 Quality Management System—requirements. This standard deals with quality management systems requirements. The primary focus is on the principles of quality assurance. Certification verifies an organization is in compliance with a documented quality system. Persons selected for this type of audit process are skilled in the field of quality assurance, with a sound knowledge in auditing methods and techniques. These persons do not, per se, have to be technical experts in the type of work or services being provided by a laboratory. Working for a registrar (a certifying agency), these auditors conduct audits, and where the organization has a quality system that meets the 9001 requirements, the organization will receive a certificate from the certifying agency. This certificate will attest to the fact that the organization has been audited and found to be in compliance with the quality standard.

2.1.2. International Standard—ISO/IEC 17025 general requirements for the competence of testing and calibration laboratories. This international standard deals with the technical competence of testing and calibration laboratories and their ability to comply with specific standards, test methods, and approved procedures and to assure the validity of a laboratory’s test or calibration data.

2.1.3. NIST Handbook 150—National Voluntary Laboratory Accreditation Program—procedures and general requirements

2.1.4. ANSI/NCSL Z540-1-1994 Part 1 Calibration Laboratories and Measuring and Test Equipment—general requirements

2.1.5. ANSI/NCSL Z540-2-1997 (R2002) US Guide to the Expression of Uncertainty in Measurement

2.1.6. Handbook of requirements and agreements as issued by a selected accrediting body

Chapter 3

Terms and Definitions

3.1. Terms and definitions listed below are those used throughout this book that may be of help or provide clarification. Some are excerpts from Webster’s New Collegiate Dictionary and are so noted. In other cases, it is an elaboration, clarification, or viewpoint by the author.

3.1.1. Accreditation: To consider or recognize as outstanding, to give official authorization or approval of, to provide with credentials, to recognize or vouch for as conforming to a standard (Webster’s New Collegiate Dictionary). The NIST Handbook 150 defines the term as a formal recognition that a laboratory is competent to carryout specific tests or calibrations or types of tests or calibrations.

3.1.1.1. The goal of achieving accreditation is much like the goal of an athlete deciding to compete in high jump and clearing the bar (standard) at a competitive level. In this case, at the international level, say the Olympics. It is through accreditation that a laboratory can be formally recognized by an accrediting body through mutual recognition agreements and be able to compete and provide laboratory services at the international level.

3.1.2. Adequacy of documentation: The quality manual and related documents should adequately address and satisfy all requirements imposed by standards, regulatory agencies, and