What is Failure Modes and Effects Analysis (FMEA)?

Failure Modes and Effects Analysis (FMEA) is a systematic method developed by the U.S. military in the 1940s to proactively identify and prioritize potential failures in products, processes, systems, or services, and to implement actions that mitigate associated risks. It analyzes failure modes, causes, and effects, assigning a Risk Priority Number (RPN) based on severity, occurrence, and detectability, targeting the highest risks first. FMEA is used across various industries, such as manufacturing, automotive, aerospace, and healthcare, to enhance quality, safety, reliability, and customer satisfaction while reducing costs linked to defects and downtime. It is integral to quality standards like ISO 9001 and IATF 16949 and has evolved to address modern challenges in areas like software development and business processes. Despite being resource-intensive and reliant on subjective judgment, FMEA's structured approach to risk management supports continuous improvement and cross-functional collaboration, making it an essential tool in developing robust systems and preventing costly failures.