Failure Mode and Effects Analysis (FMEA)

Failure Mode and Effects Analysis (FMEA) is the logical capability of systematically identifying potential failure modes of a product (DFMEA) or a manufacturing process (PFMEA), evaluating their severity, likelihood of occurrence, and detectability, and prioritizing mitigations. The output is a structured worksheet — failure mode → effect → cause → control → action — typically scored by Risk Priority Number (RPN) or, in AIAG-VDA 2019, by Action Priority.

What it covers

• Design FMEA (DFMEA) — failure modes of the product itself, traced to functions and requirements.
• Process FMEA (PFMEA) — failure modes of each manufacturing or assembly operation.
• Severity / Occurrence / Detection rating with cross-team consensus.
• Risk Priority Number (RPN) or AIAG-VDA Action Priority for ranking.
• Linkage to design changes, control plans, work instructions, and CAPAs.

Relationships (see sidebar)

• Supports the Risk Management, Quality Management, and Detailed Design processes.
• Has part the Risk Matrix — a key visualization of the FMEA dataset.
• Conforms to the ISO 14971 risk-management framework for medical devices and complementary AIAG-VDA / IEC 60812 references.