Failure Mode and Effects Analysis (FMEA) is a structured approach to anticipating what can go wrong before it does. For each step in a manufacturing process (Process FMEA) or each component in a design (Design FMEA), the team identifies potential failure modes, assesses the severity of each failure's effect, the likelihood of occurrence, and the ability of current controls to detect the failure before it reaches the customer.
Each failure mode receives a Risk Priority Number (RPN) calculated as Severity x Occurrence x Detection, each scored 1-10. High-RPN failure modes are prioritized for corrective action. After improvements are implemented, the FMEA is updated with new ratings to verify that risk has been reduced.
FMEA is required by IATF 16949 for automotive suppliers, expected by AS9100 for aerospace, and considered best practice across regulated manufacturing. The exercise is most valuable when performed by a cross-functional team — design engineers, process engineers, quality engineers, and production operators — who collectively understand how failures actually manifest. Living FMEAs that are updated with real production data become increasingly powerful risk management tools over time.