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Failure Mode and Effect Analysis and Risk Analysis for Medical Applications
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>> 100s of books, vhs, dvd at our FMEA shop <<
Product Development, Quality Assurance, Risk Management and many more

Failure Mode and Effect Analysis : FMEA from Theory to Execution  Author : D.H. Stamatis

This book is The Reference for FMEA.

It is a complete guide to failure mode and effect analysis (FMEA) - the process of understanding and applying a methodological approach to problems, errors, and failures. Author D.H. Stamatis explains the process of conducting system, design, process, and service FMEAs, and provides the rationale for doing so. Issues that are completely addressed include: What an FMEA is, how an FMEA is used, if FMEA can be applied to all industries, how FMEA applies to service industries, how it applies to the ISO 9000 series of quality standards, and more. This text also establishes the legal need for an FMEA and its relationship to product liability. A variety of examples of FMEA forms, checklists, and sample guidelines is another unique feature of this book. A summary of mathematical formulae and tools used in FMEA is also presented. The more than 10 real-world examples and how-to specifics show how FMEA can work for any organization.

Guidelines for Failure Modes and Effects Analysis (FMEA) for Medical Devices by Dyadem Press

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. These guidelines focus 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. Guidelines for Failure Modes and Effects Analysis for Medical Devices is written as a practical guide to achieving corporate consistency while dramatically cutting the time required for studies. It will help you prevent patient injuries, costly product recalls, and production department down-time. 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.

 FMEA Author's Edition  Author : Paul Palady

Introducing exclusive new developments adopted by the industry standard for design and process risk analysis and risk management. These new developments, along with several other new strategies, were developed over the past nine years in approximately 200 seminars conducted at 14 universities and 45 corporations by the author. The developments and strategies presented in this book will restore FMEA as the universal tool for risk analysis and risk management for both design and process.

Hardcover Published 1997


The Basics of FMEA by Robin E. McDermott, Raymond J. Mikulak, Michael R. Beauregard

The FMEA Best Seller

Explains failure mode and effect analysis simply and concisely. Discusses when to use FMEAs (e.g., during design, manufacturing, etc.). Shows how to perform FMEAs step-by-step. The book also discusses the QS-9000 requirement and is an ideal hands-on team resource, training supplement, and reference.

This book provides simple, easy to read and understand of the concept of FMEA. Although it is use to determine the possibility of a failure and the consequence but it is also useful for risk assessment.

The step-by-step examples bring the readers to the final picture on how to complete the FMEA cycle will surely benefit all of us!

The FMEA Pocket Handbook by Kenneth Dailey

The Cheapest FMEA handbook, a must have.

Speak the Language - Understand the Concepts - Know the Techniques "The FMEA Pocket Handbook" is intended as a reference guide covering the terms, concepts and techniques involved in the FMEA system.

It is written in an easy to understand fashion making it useful to both the seasoned Professional and the Novice.

Paper Back - .166" x 3 ¾" x 5 ½" - 40 Pages - 30 Visuals - 6 Tables - 33 Definitions

Root Cause Failure Analysis  by R. Keith Mobley

A guide for evaluating most recurring and serious incidents that may occur in a chemical plant. It introduces the RCFA method to define deviations from acceptable performance levels, isolate the root causes of equipment failures, and develop cost-effective corrective actions that prevent recurrence. The three parts present analysis techniques used to investigate and resolve reliability-related problems; specific design, installation, and operating parameters for particular types of plant equipment; and a troubleshooting guide for most of the machine types found in a chemical plant.

The Root Cause Analysis Handbook: A Simplified Approach to Identifying, Correcting, and Reporting Workplace Errors by Max Ammerman

This handbook offers an effective and integrated approach to the root cause identification and problem solving process.
An excellent source of information that explains the 'how-to' from cradle to grave. 
What You Can Learn From Things that Go Wrong : a Guidebook to the ROOT CAUSES of Failure
by C. Robert Nelms

None of us really know anything until we invade the areas of our lives in which we are ignorant and discover for ourselves the truth of our existence.
A 186 page "textbook", this book is a refreshing alternative to the typical, boring, "black - and - white style" textbooks written about Root Cause Failure Analysis. Full of stories, clip art, humor and passion, this book is a practical cookbook, a moral lesson and a philosophical journey all-in one. In addition to explaining HOW to arrive at "root cause", the author also explains, through numerous examples, WHY he has developed the methods he uses. This most popular of Fail safe's publications is the basis for its four day course entitled "The Root Cause Experience."


Guidelines for Failure Mode and Effects Analysis (FMEA), for Automotive, Aerospace, and General Manufacturing Industries by Dyadem Press

These guidelines form a comprehensive overview of Failure Mode and Effects Analysis (FMEA) and examine 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 ensure safety and regulatory compliance. They will obtain sound advice on selecting a study team, stetting 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.

Root Cause Analysis : A tool for Total Quality Management

A practical guide for Root Cause Analysis as a tool for improvement.

The QFD handbook

A book/disk how-to guide for companies planning to initiate a QFD program, and for those that already have one in place. Explains basic and advanced QFD principles and practices, such as Taguchi methods, FMEA, TRIZ, and Business Process Reengineering. Covers traditional areas as well as QFD in ISO 9000, QS 9000, environmental life cycle, service design, robust design, and software design. The companion disk contains interactive software that helps QFD teams develop, deploy, and manage a program. For executives, managers, engineers, and R&D professionals. Includes a glossary and forms.

Root Cause Analysis  by Robert Latino

Undesirable outcomes, chronic failure, incidents, and accidents… The cost of such events to corporations is high, generally adding up to tens and hundreds of millions of dollars in "accepted" losses. Why accept these losses? What if you could understand why these errors occur and eliminate chronic events from occurring altogether? Root Cause Analysis: Improving Performance for Bottom-Line Results, Second Edition shows how to identify, understand, and prevent chronic problems that hinder the attainment of organizational goals using Root Cause Analysis (RCA). The PROACT software, voted "Product of the Year" by Plant Engineering Magazine, and the steps outlined in this text teach you how to automate the RCA process. Used effectively, the information in Root Cause Analysis will improve the reliability of your plant assets and save your company precious time and money.

Management Systems and Organizational Performance : The Search for Excellence Beyond ISO9000 by Martin F. Stankard

Martin's book is an excellent tool for organizations beginning the journey to performance excellence. While many performance excellence experts and consultants discuss the complexities and linkages of the Baldrige model, Martin focuses on the simple parts of a system that improve an organization - the four cycles of high performance. In addition to the cycles discussion, Martin also provides a nice overview of organizational assessment, the options available for assessment, and recommendations. Throughout the book, Martin relates the four cycles and assessments to the PDCA cycle as a way of ensuring continual improvement. A must read for anyone in an organization considering adopting a performance excellence model for improvement or is already on the pathway to performance excellence!

Design of Experiments Using The Taguchi Approach by Ranjit K. Roy

Explains Dr. Taguchi's approach to making the design of experiments more effective and consequently improve the quality of products and processes. The book begins with techniques for designing simple experiments, followed by steps applying the same methodology to study interactions between factors and mixed-level factor designs. Advanced techniques to analyze experimental results and Taguchi robust design strategy are covered in the last several steps. Topics include orthogonal arrays, analysis of variance, combination designs, and analysis using signal-to-noise ratios. Case studies are provided. The CD-ROM contains Qualitek-4 software for automatic experiment design and analysis.

Apollo Root Cause Analysis - A New Way Of Thinking by Dean L. Gano, Vicki E. Lee, Wendy C. Mitchell

Apollo Root Cause Analysis is about effective problem solving. It is truly a new way of thinking that will ensure you find an effective solution to almost any kind of problem. You will discover new communication tools that are revolutionizing the way people all around the world think, communicate, and make decisions together. This is a life changing book that will enable you and your organization to effectively communicate without the usual conflicts. Apollo Root Cause Analysis creates a common reality that everyone can see and understand. With this common reality, communications becomes crystal clear for everyone involved. Everyone can clearly see how the solutions will prevent recurrence, are within their control and will accomplish their goals and objectives. Imagine your next meeting without the usual arguments and power politics.
Nothing happens without a cause. You will learn more about the cause and effect principle than has ever been documented before. Most notable is the fact that every time we ask why? we should find at least two causes and when we continue to ask why? we discover that there is an infinite set of causes limited only by our lack of knowledge. By documenting these branched causes we are able to create a visual dialog that ensures an effective solution every time.

You will learn why 70% to 80% of the general population are ineffective problem solvers and why conventional problem solving methods don't work. You will also learn the secrets of highly effective problem solvers.

The book opens with a chapter on the pitfalls of problem solving and why 70% to 80% of the population are ineffective problem solvers. Chapter 2 provides a complete description of the cause and effect principle to include a new discussion on why our linear language causes linear thinking which prevents effective problem solving. Chapter 3 provides a complete description of the Apollo tools to include a completely new way of looking at evidence. Chapter 4 is all about effective solutions. Chapter 5 discusses how to institutionalize the Apollo methodology and chapter 6 covers how to facilitate an investigation. Included in this discussion is how to avoid the common traps of ineffective problem solving. The book also includes an Appendix that compares the different root cause analysis methods.

Amdec. guide pratique by G. Landy

L'AMDEC Produit et l'AMDEC Procédé se généralisent aujourd'hui dans les entreprises. Après le secteur automobile, chacun peut faire sa propre démarche d'analyse de problème potentiel avec l'outil AMDEC.

Cet ouvrage présente «comment mettre en œuvre vos amdec... ». Essentiellement pratique, il a été conçu comme un guide de mise en place de la méthode : des pré-requis à l'animation de vos groupes AMDEC, jusqu'au suivi des actions correctives, ou préventives...

Cette nouveauté, par son approche originale, prouve que la logique AMDEC s'intègre parfaitement à une culture d'amélioration continue.

Les actions préventives qui seront menées à la suite de votre analyse AMDEC participent à la mise en œuvre de l'amélioration continue dans le cadre d'un projet de certification ISO 9001 version 2000.

Manufacturing Insights: Failure Mode Effects Analysis (FMEA)  Video !

This video was produced in cooperation with Robert Bosch Corporation in Farmington Hills, Michigan. The program is an introduction to the quality methodology Failure Mode Effects Analysis (FMEA). As every new product is being designed, most manufacturing companies are developing FMEA documents to reduce the risk of product failures. In addition, quality standards like ISO9000 and QS9000 require an FMEA on all new products. To shorten development cycles, many different experts are involved in the design and testing phases of new products. After viewing this tape, every person on your design team will have a good understanding of the importance of risk reduction and how the FMEA will keep track of these responsibilities. This video was design to quickly bring all the team members up to speed on how the FMEA methods and procedures will impact them. Learning Objectives: A general understanding of why companies do FMEAs; What is the difference between a product and a! process risk?; What can companies do to minimize risks?; See how FMEA documents track responsibilities to reduce risks; How an FMEA is used within Robert Bosch Corporation.

100s of books, vhs, dvd at our FMEA shop <<
Product Development, Quality Assurance, Risk Management and many more


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Failure Mode and Effect Analysis and Risk Analysis for Medical Applications
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