Usability Challenges of Failure Mode and Effects Analysis

This technical report discusses the usability challenges associated with Failure Mode and Effects Analysis (FMEA) within the V-model framework in systems engineering. FMEA has been a widely adopted tool for predictive failure analysis and reliability assessment for over 70 years, particularly in regulated industries like medical devices. Despite its extensive use, FMEA faces criticism regarding its usability and effectiveness. The report reviews the methodology of FMEA in relation to the V-model, identifying systemic challenges that practitioners encounter when integrating these two processes. It outlines the historical context of FMEA, including its origins and evolution across various industries, and emphasizes the importance of user interfaces in preventing use errors. The authors propose systematic solutions to enhance the usability of FMEA within the V-model, aiming to improve its application in complex systems. The report concludes with a summary of findings and suggests future research directions to address the identified challenges.