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Quality Management (QMS) 15 items

Process FMEA (PFMEA) Review Checklist

Reviews a Process Failure Mode and Effects Analysis for completeness and rigor following the AIAG-VDA seven-step approach.

AIAG-VDA FMEAIATF 16949:2016

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Planning & Structure (Steps 1–2)

  • Is the PFMEA scope, team, and timing defined (Step 1 Planning & Preparation)? *
  • Is a structure/process flow analysis established identifying process steps and work elements (Step 2)? *
  • Process / part reference *

Function & Failure Analysis (Steps 3–4)

  • Are functions and requirements defined for each process step (Step 3)? *
  • Are failure modes, failure effects, and failure causes identified and linked (Step 4)? *
  • Do failure effects reflect impacts at the plant, ship-to plant, and end user? *

Risk Analysis (Step 5)

  • Are Severity, Occurrence, and Detection rated using the current AIAG-VDA rating tables? *
  • Are current prevention and detection controls documented for each cause? *
  • Is Action Priority (High/Medium/Low) assigned instead of relying solely on RPN? *

Optimization (Step 6)

  • Are actions defined for all High and Medium Action Priority items? *
  • Are action owners and target completion dates assigned? *
  • Are Severity/Occurrence/Detection re-evaluated after actions are completed? *

Linkage & Documentation (Step 7)

  • Are special characteristics flowed to the control plan and work instructions? *
  • Is the PFMEA a living document updated on change or new failure information? *
  • Reviewer signature *

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