FMEA

Failure Modes and Effects Analysis (FMEA) is a structured, proactive risk assessment technique used to identify where and how a product or process might fail, assess the relative impact of different failures, and develop actions to mitigate or eliminate them. The goal is to improve reliability, safety, and quality by addressing potential failures before they occur.

Origin and scope: FMEA originated in mid-20th century manufacturing and aerospace practice and is now widely used across industries such as automotive, electronics, and medical devices. It is guided by standardized methodologies from organizations such as AIAG and VDA, and it is applied in design, development, and manufacturing contexts.

Process: FMEA is typically conducted by a cross-functional team. It involves listing potential failure modes for each function or step, identifying their causes and effects, and assigning severity (S), occurrence (O), and detection (D) ratings. The Risk Priority Number (RPN) is calculated as S × O × D to help prioritize actions. Teams define mitigation measures, assign owners, set deadlines, and update the analysis as changes occur.

Variants and outputs: The main variants are Design FMEA (D-FMEA) and Process FMEA (P-FMEA). Some organizations use related approaches such as FMECA (Failure Modes, Effects, and Criticality Analysis) or alternative risk metrics to emphasize critical issues. Deliverables typically include a FMEA worksheet, action plans, and documentation of changes.

Applications and limitations: FMEA is widely used to reduce risk in product design and process development, prevent field failures, and support continuous improvement. Limitations include reliance on team expertise, potential subjectivity, and criticisms of the traditional RPN metric, which has prompted the development of alternative prioritization approaches.