Pfmea Process Fmea Drafter
v0.1.0Use when a quality engineer, manufacturing engineer, supplier-quality engineer, process engineer, or APQP / PPAP lead at an automotive, aerospace, medical-device, or industrial supplier needs to draft a Process Failure Mode and Effects Analysis (PFMEA) aligned to the AIAG-VDA FMEA Handbook (2019, current 2026 edition) seven-step approach. Guides scoped intake of programme, customer, regulatory frame (IATF 16949 / AS9100 / 21 CFR 820 / MIL-STD-1629 / customer-specific), prior PFMEA / DFMEA / control plan / process flow, cross-functional team roster, and scope IN / OUT; walks Step 1 planning and preparation, Step 2 process structure analysis (Process Item → Process Step → Process Work Element with 4M / 6M categorisation), Step 3 function analysis (three-tier function tree), Step 4 failure analysis (Failure Effect → Failure Mode → Failure Cause chain), Step 5 risk analysis (Severity 1–10 of effect at the end customer, Occurrence 1–10 of cause given current prevention control, Detection 1–10 of current detection control, with current prevention and current detection controls identified separately), Step 6 optimisation (preventive and detective actions with single named owner and effectiveness-verification method, with S / O / D and AP re-scored after verification), Step 7 results documentation; assigns the AIAG-VDA Action Priority (AP) — High / Medium / Low — that **replaces** the Risk Priority Number, and produces a DRAFT PFMEA worksheet with a Top-N High-AP action list, optimisation action plan, reanalysis-trigger list, and cross-functional-team review-and-sign-off block — for cross-functional team review before any control-plan update, PPAP package, customer Source-Inspection submission, or audit. Never finalises a PFMEA, never signs or submits PPAP, never authorises production, never opines on customer Source-Inspection waivers, never substitutes RPN for AP when the AIAG-VDA Handbook applies, and never overrides the cross-functional team's or the responsible engineer's judgement.
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