FMEA (Failure Mode and Effects Analysis) is a systematic risk analysis that, before the failure occurs, identifies possible failure modes in a product or process, assesses severity, occurrence and detectability, and prioritises preventive actions.
FMEA is carried out in cross-functional teams: design FMEA on the product, process FMEA on manufacturing. The AIAG-VDA harmonisation (2019) replaced the classic Risk Priority Number (RPN) with Action Priority (AP), which weights severity more heavily.
An FMEA is a living document: it is updated on changes, complaints and new failure modes — an FMEA made once for the customer’s audit is wasted work.