Risk Management: How to Assess and Control Risk Related to Human Error in Products and Systems

Risk Management is a practical guide to applying risk management tools such as FMEA (failure modes and effects analysis) and FTA (fault tree analysis) to products and systems with a focus on user interactions and human error (aka “use error”). Unlike some books on the topic, Risk Management includes step-by-step instructions, advice, and caveats while illustrating the methods using hypothetical case studies. The authors also offer tips on how to avoid common pitfalls.

Risk Management provides the tools for

• planning and conducting use error FMEAs and FTAs, from the beginning stages of setting goals, to creating a team, executing the plan, and documenting findings;
• understanding other use-related risk management tools, including URRA (use-related risk analysis), fishbone diagrams, and bowtie diagrams; and
• understanding the unique application of use-related risk management for regulatory approval of medical products.

The book offers useful tools for user interface designers, human factors practitioners, engineers, quality and regulatory personnel, product regulators, and product development managers, as well as serving as an instructional guide for faculty and students. Novices with no experience to those who are knowledgeable about general risk management methods but need a refresher in applying them to use-related risk will benefit.

Risk Management can inform practitioners in a broad range of areas, including consumer, medical, and industrial products, as well as transportation, power stations, aerospace, and the military.

About the Series

The Users’ Guides to Human Factors and Ergonomics Methods series aims to instruct and guide researchers, practitioners, students, and others in how to employ HF/E methods to accomplish their goals. They serve as an “expert over your shoulder,” with concise descriptions and examples in a step-by-step format.

Titles include

• Usability Assessment, Kortum
• Workload Assessment, Matthews & Reinerman-Jones
• Questionnaire Design, Moroney & Cameron
• Task Analysis, Stuster
• Situation Awareness Measurement, Endsley

About the Authors

Edmond W. Israelski is the retired director of human factors at the biopharmaceutical firm AbbVie, where he led a cross-company team to embed best-practice human factors engineering design methods into all of the firm’s products. In his current role as a consultant, Israelski provides strategic advice to medical product developers to ensure compliance with international standards and regulatory requirements of the U.S. Food and Drug Administration. A Certified Human Factors Professional, Ed holds 30 patents, is a Fellow of the Human Factors and Ergonomics Society, and is a past member of the National Academy of Sciences Board on Human-Systems Integration. He received a BS in electrical engineering from NJIT, an MS in operations research from Columbia University, and a PhD in industrial and engineering psychology from Stevens Institute of Technology.

William H. Muto retired after 22 years as a principal human factors engineer at Abbott Labs. During his tenure, while playing a key role in the design and evaluation of a wide variety of medical products, he helped establish human factors as a core discipline in the company and assisted in the development of corporate-wide human factors policies a d procedures. He holds a PhD in industrial engineering (with a human factors specialty) from Virginia Tech. He is a Certified Professional Ergonomist and Fellow of the Human Factors and Ergonomics Society. Muto served for more than 15 years on the Association for the Advancement of Medical Instrumentation’s Human Factors Engineering Committee and is a past director and officer of the Board of Certification in Professional Ergonomics.