When Should FMEA Be Performed?
FMEA is a living tool that must be reviewed and updated in response to specific trigger cases.
Core scenarios requiring implementation or revision include:
Design or process changes.
Changes in operating conditions.
Updates to regulatory requirements or customer expectations.
Quality issues such as zero-mile or field failures.
Changes in Hazard and Risk Assessments (HARA/TARA).
Findings from product inspection or monitoring.
Lessons learned and opportunities for improvement.