FMEA Review Checklist for DFMEA and PFMEA (Free)

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10 critical items still open - these are the highest-risk gaps.

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Scope and team

Scope, boundaries and part or process revision are statedCRITICALTeam is cross-functional (design, process, quality, production, maintenance)Customer requirements and special characteristics are listed as inputsCRITICALFMEA type and method are named (DFMEA, PFMEA, AIAG-VDA or earlier)Related documents are referenced: process flow, control plan, drawingsDocument has a revision history and approval

Structure and function

Every process step in the flow diagram appears in the FMEACRITICALFunctions are written with a verb and a measurable requirementRework, repair, transport and storage steps are includedInterfaces between steps or components are addressedLessons learned and field issues from similar products are reviewedOutsourced steps and supplier processes are covered

Failure chain

Failure modes are stated as loss of function, not as causesCRITICALEffects are described for next operation and end customerEach failure mode has at least one cause at root levelCauses are specific enough to be controlled (not just operator error)Safety and regulatory effects are identifiedNo lines are marked not applicable without a reason

Ratings

Severity, occurrence and detection use a controlled, documented scaleCRITICALSeverity relates to the effect and is not lowered by controlsCRITICALOccurrence ratings are supported by data or historyDetection ratings are based on controls that exist todayRatings are consistent between similar linesLines with severity 9 or 10 have actions or documented justificationCRITICALRisk ranking (RPN or action priority) is calculated correctly

Actions and follow-up

Every high-priority line has an owner and target dateCRITICALActions prevent causes first, detection secondRe-rating happens only after the action is implemented and verifiedOpen actions are tracked in a visible logManagement reviews overdue actions

Links and maintenance

Control plan includes the controls listed in the PFMEACRITICALSpecial characteristics match drawings and the control planFMEA is updated after customer complaints, scrap trends and process changesCRITICALFMEA is reviewed at least annually even without changeRecords link to part number and revision in PLM or ERPPrevious revisions are retained and obsolete copies removed

Count the items you can answer yes to. Fix every unchecked critical item before the FMEA goes to a customer or auditor.

Get an expert read of your FMEA process

Optional: ask for feedback on how FMEA, control plans and ERP records fit together.

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How to use the checklist

Open the FMEA and the process flow side by side and go through the groups in order. Tick each item you can verify from the documents, not from memory. Mark gaps and note owners. The critical items are the ones that most often cause audit findings or customer rejection: missing steps, causes written as modes, ratings that lack evidence and unclosed severity 9 and 10 lines. Run the review with someone who did not write the FMEA.

Review with the flow diagram and control plan open
Sample at least ten lines in depth
Trace three actions from open to verified evidence
Record findings and re-review after fixes

What reviewers should look for

Start with scope and flow completeness, since all later quality depends on it. Then test the failure chains: can each cause actually produce the stated mode and effect? Check ratings against the agreed scale and against data such as scrap, returns or capability studies. Finally follow the thread into actions and the control plan. An FMEA with perfect formatting but no connection to the real process is the commonest hidden failure.

Reading your score

A high yes rate with all critical items passed means the FMEA is ready for review. Many unchecked critical items suggest the FMEA was written as a paperwork exercise and needs a team session. If only the links group fails, the FMEA may be sound but disconnected from the control plan and routing. Prioritise fixes by effect on customers: safety lines, then special characteristics, then the rest.

Common mistakes

Typical findings include copied FMEAs not adapted to the new part, detection ratings based on inspection that is not actually performed, and RPN arithmetic that does not match the ratings. Another is an FMEA that is never updated after a customer complaint. Keep a living document, review it in each quality meeting, and tie updates to corrective action closure so lessons are captured permanently.

Frequently Asked Questions

Who should review an FMEA?

Someone independent of the author, ideally a quality or reliability engineer with process knowledge, plus a representative from production. Customer or auditor reviews come on top of the internal review.

How often should an FMEA be reviewed?

At least annually, and whenever there is a design or process change, a customer complaint, a nonconformance trend or a new customer requirement. Treat the FMEA as a living record.

What are the most common FMEA audit findings?

Missing process steps, causes written as failure modes, unsupported ratings, high severity lines without action, and a control plan that does not match the PFMEA are the most frequent.

Does this checklist work for AIAG-VDA FMEAs?

Yes. The items cover scope, structure, function and failure analysis, ratings and action tracking, which apply to both the older format and the seven step AIAG-VDA method.

If you want FMEA, nonconformance and ERP records reviewed together, Netray can discuss a read-only data review. The checklist is free and stands alone.

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