The PFMEA (Process FMEA) is the risk analysis that identifies, for each manufacturing step, how the process can fail to deliver the product characteristic, what the effect of that failure is for the plant, for the customer and for the end user, and which controls prevent or detect the failure. In IATF 16949:2016 it is required as an output of the manufacturing process design (clause 8.3.5.2), it has to consider the special characteristics (8.3.3.3), it supports the control plan (8.5.1.1) and it must be reviewed whenever there is a quality problem, a customer complaint or a change (10.2.3 and 8.5.6.1). The current reference manual is the AIAG-VDA FMEA Handbook (1st edition, 2019).

The AIAG-VDA format organizes the work in 7 steps: 1) planning and preparation (scope, team, schedule — the 5T), 2) structure analysis (process item, process step, 4M work elements), 3) function analysis, 4) failure analysis (the effect-mode-cause chain), 5) risk analysis, 6) optimization and 7) results documentation. The big change compared with the AIAG 4th edition is the end of the RPN (S x O x D) as the prioritization criterion. In its place comes Action Priority (AP), read from tables in the handbook that combine S, O and D and give more weight to severity, then to occurrence and last to detection. AP High (H) requires action to improve prevention or detection, or a documented justification of why the current controls are adequate; AP Medium (M) must have an action or a justification; AP Low (L) may have an action. For example, severity 9-10 with occurrence 4 or higher results in H even with detection between 2 and 4; whereas S 9-10 with O 2-3 and D 2-4 results in L.

The most common findings raised by third-party auditors are: a generic PFMEA, copied from another part, that does not reflect the real flow; special characteristics on the drawing with no link to the PFMEA and the control plan; occurrence rated without data (complaints, scrap, capability history); a detection rating of 2 or 3 assigned to visual inspection; a PFMEA not updated after the 8D of a customer complaint; and error-proofing devices quoted as a control without periodic verification that they work (10.2.4).

To fill it in, start from the process flow diagram, break each step down into 4M work elements (machine, man, material, method, and environment where applicable) and write the failure chain in objective language. Rate S by the worst effect, O considering the effectiveness of the prevention control and D considering the real capability of the detection control to catch the cause or the failure mode before shipping. Then look up the AP table and record actions with an owner and a due date, re-rating S/O/D after implementation.

The example below is a progressive stamping process with projection nut welding, a typical Tier-2 supplier process, and it shows AP values consistent with the AIAG-VDA tables.