Definition:
Failure Modes and Effects Analysis (FMEA) is a classical qualitative method for identifying potential failure modes, their causes and effects on system operation.
FMEA is explicitly named in IEC 61508-7:2010, Annex B.6.6.1 (“Failure modes and effects analysis (FMEA)”). The more commonly cited method in functional safety work is the related FMEDA, which extends FMEA with failure-rate data for PFDavg calculations. Adjacent industries like pharmaceutical will use FMEA on the process side.
Key Points:
- General process to identify single points of failure.
- Generally not part of the functional safety life-cycle. This could happen very early in a facility design process, or as a precursor to the FMEDA by an equipment manufacturer.
Example:
The project team in a drug manufacturing facility performs a qualitative FMEA on a critical subsystem or interface (e.g., a new pneumatic actuator system). This would be part of the design evaluation and would occur prior to the H&RA.
See Also: FMEDA, H&RA, stated risk, QLRA
Cited Source:
- IEC 60812:2018
- ASQ article
- ENCO comparison between FMEA and FMEDA