A risk assessment method for identifying potential failures, their causes, and their effects before production issues occur.
Failure Mode and Effects Analysis (FMEA) guides teams through brainstorming what could go wrong, prioritising risks, and implementing mitigations before customers are impacted.
Steps in an FMEA
List functions, potential failures, effects, causes and current controls. Use the prioritization method required by the program. Some methods use RPN; AIAG & VDA FMEA uses Action Priority. Do not treat an RPN calculation as mandatory for every FMEA.
Linking FMEA to other tools
Insights from Root Cause Analysis feed preventive controls back into production processes.
Documented mitigations transition into CAPA assignments that teams track to completion.
Key takeaways
- FMEA anticipates failures before they reach customers.
- Use the required prioritization method and consider severity separately.
- Integration with CAPA and RCA ensures mitigations are executed.