[PDF] Measurement Process Qualification eBook

Author : Edgar Dietrich
Publisher : Hanser Gardner Publications
Page : 431 pages
File Size : 29,66 MB
Release : 2011
Category : Technology & Engineering
ISBN : 9781569905050

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In production, measurement process capability studies are required. This requirement is obligatory according to several international standards, guidelines and company guidelines of the automotive industry. Due to this requirement, the risk of product liability is to become appreciable and controllable. While the automotive industry implemented gage capability studies during the last years, today, the determination of the extended measurement uncertainty serves as an alternative to capability studies or to the applicability of measurement processes. This book gives a comprehensive overview and assists you in dealing with these requirements in industrial production. Several guidelines contained in this book (Bosch, DaimlerChrysler, General Motors Powertrain) apply the procedures described here. The acquired experience confirms the great benefit of these procedures in practice. The following standards are considered " DIN EN ISO 9001:2000 and ISO/TS 16949 " QS-9000, MSA Third Edition " VDA 6.1, VDA 5 "Measurement Process Capability" " DGQ 13-61 "Gage Management" " GUM / DIN EN V 13005 " DIN EN ISO 14253 " DIN EN ISO 10012:2003 " VDI/VDE/DGQ 2618

Author : Mark Allen Durivage
Publisher : Quality Press
Page : 129 pages
File Size : 33,51 MB
Release : 2016-07-14
Category : Business & Economics
ISBN : 0873899369

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For the past decade, process validation issues ranked within the top six of Food and Drug Administration (FDA) form 483 observation findings issued each year. This poses a substantial problem for the medical device industry and is the reason why the authors wanted to write this book. The authors will share their collective knowledge: to help organizations improve patient safety and increase profitability while maintaining a state of compliance with regulations and standards. The intent of this book is to provide manufacturing quality professionals working in virtually any industry a quick, convenient, and comprehensive guide to properly conduct process validations that meet regulatory and certification requirements. It will aid quality technicians, engineers, managers, and others that need to plan, conduct, and monitor validation activities.

Author : Alain Abran
Publisher : Springer Science & Business Media
Page : 359 pages
File Size : 27,51 MB
Release : 2009-11-02
Category : Computers
ISBN : 3642054145

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This book constitutes the refereed proceedings of two joint events - the International Workshop on Software Measurement, IWSM 2009 and the International Conference on Software Process and Product Measurement, Mensura 2009, held in Amsterdam, The Netherlands, in November 2009. The 24 revised full papers presented were carefully reviewed and selected from numerous submissions for inclusion in the book. This book considers issues such as the applicability of measures and metrics to software, the efficiency of measurement programs in industry and the theoretical foundations of software engineering.

Author : Chee Kai Chua
Publisher : Academic Press
Page : 270 pages
File Size : 26,58 MB
Release : 2017-06-03
Category : Technology & Engineering
ISBN : 0128134909

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Standards, Quality Control and Measurement Sciences in 3D Printing and Additive Manufacturing addresses the critical elements of the standards and measurement sciences in 3D printing to help readers design and create safe, reliable products of high quality. With 3D printing revolutionizing the process of manufacturing in a wide range of products, the book takes key features into account, such as design and fabrication and the current state and future potentials and opportunities in the field. In addition, the book provides an in-depth analysis on the importance of standards and measurement sciences. With self-test exercises at the end of each chapter, readers can improve their ability to take up challenges and become proficient in a number of topics related to 3D printing, including software usage, materials specification and benchmarking. Helps the reader understand the quality framework tailored for 3D printing processes Explains data format and process control in 3D printing Provides an overview of different materials and characterization methods Covers benchmarking and metrology for 3D printing

Author : Giulio Barbato
Publisher : Società Editrice Esculapio
Page : 249 pages
File Size : 39,26 MB
Release : 2013
Category : Technology & Engineering
ISBN : 887488575X

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In the technical-scientific field, many decisions are supported by measurements. However, it is essential to assign to measurement results their actual meaning to achieve a correct decision. This aspect is particularly important and formally required when operating in Quality Systems. Therefore, measures management must be rigorous and it can find a concrete support in the topics discussed in this volume, because of the attention to metrological part and the removal of unnecessary restrictions.

Author : Chung Chow Chan
Publisher : John Wiley & Sons
Page : 363 pages
File Size : 15,77 MB
Release : 2011-03-01
Category : Science
ISBN : 1118060318

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Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirements Complementing the authors' first book, Analytical Method Validation and Instrument Performance Verification, this new volume provides coverage of more advanced topics, focusing on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testing. Readers will gain new and valuable insights that enable them to avoid common pitfalls in order to seamlessly conduct analytical method validation as well as instrument operation qualification and performance verification. Part 1, Method Validation, begins with an overview of the book's risk-based approach to phase appropriate validation and instrument qualification; it then focuses on the strategies and requirements for early phase drug development, including validation of specific techniques and functions such as process analytical technology, cleaning validation, and validation of laboratory information management systems Part 2, Instrument Performance Verification, explores the underlying principles and techniques for verifying instrument performance—coverage includes analytical instruments that are increasingly important to the pharmaceutical industry, such as NIR spectrometers and particle size analyzers—and offers readers a variety of alternative approaches for the successful verification of instrument performance based on the needs of their labs At the end of each chapter, the authors examine important practical problems and share their solutions. All the methods covered in this book follow Good Analytical Practices (GAP) to ensure that reliable data are generated in compliance with current Good Manufacturing Practices (cGMP). Analysts, scientists, engineers, technologists, and technical managers should turn to this book to ensure that analytical methods and instruments are accurate and meet GMP standards and requirements.

Author : Gregory K. McMillan
Publisher : ISA
Page : 593 pages
File Size : 28,22 MB
Release : 2010
Category : Technology & Engineering
ISBN : 1936007231

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Aims to increase awareness of the opportunities afforded by measurement instruments and final elements. This title shows how to get maximum benefit from the revolution in smart technologies. It builds an understanding of the fundamental aspects of measurements, measurement instruments, and final elements for applications in the process industry.

Author : Douglas B. Relyea
Publisher : CRC Press
Page : 215 pages
File Size : 31,52 MB
Release : 2011-04-15
Category : Business & Economics
ISBN : 1439884641

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Creating a universal language for problem solving, The Practical Application of the Process Capability Study: Evolving from Product Control to Process Control delineates the process capability study, a powerful tool that, when understood and implemented, provides benefits to every department within a manufacturing organization. With easy to read, step-by-step flow diagrams on how to perform process capability studies and measurement process analyses, the book’s coverage includes: The benefits of statistical process control over statistical product control Real-world industrial examples and case studies illustrating how to use the techniques Ways for management to determine if the investment in process capability studies is providing an appropriate return Methods to correct lack of stability and capability once either condition has been identified, such as the ANOVA technique and the simple three-factor designed experiment A flow chart that enables machine operators to execute a process capability study without interfering with productivity A great deal of information is available on the technical concepts of the process capability study, much of it emphasizing the mathematics. Unfortunately, concentrating on the math and fine distinctions, such as the difference between alpha- and beta-type errors, has created barriers preventing many from fully appreciating the basic concepts, the simplicity, and the usefulness of the tool. This book shows you how to use the process capability study to increase return on investment from your statistical process control/Six Sigma effort and make your company more competitive.