FMEA lists potential failure modes, their effects, causes, and existing controls, assigning severity, occurrence, and detection ratings. The resulting risk priority numbers direct mitigation effort.
It is standard practice in regulated manufacturing.
Alternative Names:
FMEA, Failure Modes Analysis
Why it Matters?
An FMEA identifying the exact failure that injured the plaintiff, with a severity rating acknowledging serious harm, is the most damaging document in a design case because the manufacturer analyzed and documented the risk in advance. The defense position depends on whether the identified mitigation was implemented and whether the residual risk was reasonable. An FMEA that did not identify the failure mode is separately problematic as evidence of inadequate analysis.
Frequently Confused with
Related terms
Frequently asked questions
Why is an FMEA damaging?
What if the failure mode was not identified?
