Application of ISO IEC 17025 Technical Requirements in Industrial Laboratories
Method Validation
by M.L. Jane Weitzel and Wesley M. Johnson

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The book introduces the new concepts of target measurement uncertainty and decision rules and explains how to use them to demonstrate a method is fit-for-purpose. As well, they can be used to set the acceptance criteria for a method validation clearly and quantitatively. Examples are given that illustrate the concepts so that the reader can easily apply decision rules and target measurement uncertainty to their methods. The book covers all aspects of method validation from stating the purpose of the method using a Decision Rule, calculating the target measurement uncertainty, deciding the required parameters that need to be included in the method validation, estimating the measurement uncertainty, and setting the acceptance criteria. With this approach the reader will fully understand the method, what its critical control points are and what to control and monitor during routine use. This approach fits in well with the lifecycle approach to analytical methods. The book covers the basics and advanced aspects of method validation so that it is useful for people new to method validation and those with experience. The book is applicable for laboratories in many industries, from mining to pharmaceutical manufacturing to food analysis.

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Jane Weitzel and Dr. Johnson have developed and presented numerous workshops on Quality Control/Quality Assurance, Method Validation, Estimating Measurement Uncertainty, Basic Statistics, Traceability, and Accreditation to ISO/IEC Standard 17025 in many industries around the world. Jane Weitzel has worked in analytical chemistry for over 35 years in highly regulated, fast paced companies, with the last 5 years at the director/associate director level. She is currently a full time consultant and assessor. Jane has conducted audits internationally for pharmaceutical companies, including audits for cause, and has conducted third party audits for accreditation to ISO 17025. Jane is active on the “Analytical Laboratory Accreditation Criteria Committee” (ALACC) of AOAC International which publishes “AOAC INTERNATIONAL Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food and Pharmaceuticals”. Dr. Johnson has many years of experience in commercial, industrial and government laboratories as an analyst, manager and Quality Control/Quality Assurance officer. He is retired from teaching Analytical and Environmental Chemistry at Okanagan University College. He has served as an auditor for industry and for laboratory accrediting bodies in over 50 accreditation visits. His consulting engagements included assistance in attaining accreditation to ISO/IEC Standard 17025, general consulting concerning analytical problems, laboratory efficiency and method development.

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Contributors

Author

M.L. Jane Weitzel

Author

Wesley M. Johnson

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