Failure Mode and Effects Analysis (FMEA)

Failure mode and effects analysis is a structured, team-based method for identifying how a product or process could fail, what the effects would be, and what causes and controls exist, so that risks can be prioritised and reduced before failures occur.

An FMEA examines each function or process step in turn, listing potential failure modes, their effects on the customer or the next process, their causes, and the current prevention and detection controls. Each failure is rated for severity, occurrence and detection, traditionally on scales of one to ten. The traditional risk priority number is the product of the three ratings; the AIAG and VDA FMEA Handbook introduced action priority tables, which weight severity most heavily, as an alternative to ranking by RPN. Actions are then defined to reduce the highest risks.

Design FMEA analyses a product design, while process FMEA analyses manufacturing and assembly processes; variants exist for systems, software and machinery. FMEA originated in military and aerospace practice in the United States and is now a core quality tool in the automotive industry, where it is linked to APQP and control plans, and it is widely used in medical devices, electronics and process industries. Failure modes, effects and criticality analysis extends the method with a criticality assessment.

FMEA works best when started early and maintained as a living document, updated after design changes, failures and lessons learned. Its value depends on cross-functional input and honest ratings. Multiplying ordinal ratings into an RPN has known weaknesses, since very different risks can share the same number. IEC 60812 describes procedures for both FMEA and FMECA.

Key points

Rates failure modes for severity, occurrence and detection.
Design FMEA covers products; process FMEA covers manufacturing processes.
The AIAG and VDA handbook uses action priority instead of ranking by RPN.
A living document linked to APQP and control plans.
IEC 60812 describes FMEA and FMECA procedures.

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Related terms

Terms that refer to Failure Mode and Effects Analysis (FMEA)

Corrective and Preventive Action (CAPA)Industry 4.0 & Manufacturing Operations