Guidelines For Failure Modes And Effects Analysis For Medical Devices
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Guidelines for Failure Modes and Effects Analysis for Medical Devices
Challenged by stringent regulations, vigorous competition, and liability lawsuits, medical device manufactures must develop safe, reliable, and cost-effective products, and managing and reducing risk is a vital element of reaching that goal. A practical guide to achieving corporate consistency while dramatically cutting the time required for studies, Guidelines for Failure Modes and Effects Analysis for Medical Devices focuses on Failure Modes and Effects Analysis (FMEA) and its application throughout the life cycle of a medical device. It outlines the major U.S. and E.U. standards and regulations and provides a detailed yet easy-to-read overview of risk management and risk analysis methodologies, common FMEA pitfalls, and FMECA-Failure Mode, Effects, and Criticality Analysis. Discover how the FMEA methodology can help your company achieve a more cost-effective manufacturing process by improving the quality and reliability of your products. This new FMEA manual from the experts at Dyadem is the ultimate resource for you and your colleagues to learn more about Failure Modes and Effects Analysis and then teach others at your facility. This comprehensive manual is sure to become a standard reference for engineering professionals.
Guidelines for Failure Mode and Effects Analysis (FMEA), for Automotive, Aerospace, and General Manufacturing Industries
These guidelines form a comprehensive overview of Failure Mode and Effects Analysis (FMEA) and examines why FMEA has become a powerful and respected analytical technique for effectively managing and reducing risks. Readers learn how to use FMEA throughout the life cycles of their product to improve customer satisfaction and assure safety and regulatory compliance. They will obtain sound advice on selecting a study team, setting up and conducting a study, and analyzing the results. Other topics include Failure Mode, Effects, and Criticality Analysis, Risk Management Planning, Advanced Quality Planning, Product Quality Control Plans, and Dynamic Control Plans.
Effective FMEAs
Outlines the correct procedures for doing FMEAs and how to successfully apply them in design, development, manufacturing, and service applications There are a myriad of quality and reliability tools available to corporations worldwide, but the one that shows up consistently in company after company is Failure Mode and Effects Analysis (FMEA). Effective FMEAs takes the best practices from hundreds of companies and thousands of FMEA applications and presents streamlined procedures for veteran FMEA practitioners, novices, and everyone in between. Written from an applications viewpoint—with many examples, detailed case studies, study problems, and tips included—the book covers the most common types of FMEAs, including System FMEAs, Design FMEAs, Process FMEAs, Maintenance FMEAs, Software FMEAs, and others. It also presents chapters on Fault Tree Analysis, Design Review Based on Failure Mode (DRBFM), Reliability-Centered Maintenance (RCM), Hazard Analysis, and FMECA (which adds criticality analysis to FMEA). With extensive study problems and a companion Solutions Manual, this book is an ideal resource for academic curricula, as well as for applications in industry. In addition, Effective FMEAs covers: The basics of FMEAs and risk assessment How to apply key factors for effective FMEAs and prevent the most common errors What is needed to provide excellent FMEA facilitation Implementing a "best practice" FMEA process Everyone wants to support the accomplishment of safe and trouble-free products and processes while generating happy and loyal customers. This book will show readers how to use FMEA to anticipate and prevent problems, reduce costs, shorten product development times, and achieve safe and highly reliable products and processes.