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PFMEA Document Control

PFMEA document is current and revision-controlled critical (required)

Yes No N/A

Process scope and boundaries are clearly defined critical (required)

Yes No N/A

Cross-functional review and approval are documented

Yes No N/A

Reference documents and process flow links are included

Yes No N/A

Latest process changes have been incorporated critical (required)

Yes No N/A

Failure Mode and Effect Analysis

Process steps are complete and in correct sequence critical (required)

Yes No N/A

Failure modes are specific and measurable

Yes No N/A

Effects of failure are clearly described

Yes No N/A

Potential causes are identified for each failure mode

Yes No N/A

Current prevention and detection controls are documented critical (required)

Yes No N/A

Risk Rating Validation

Severity ratings are assigned using the approved scale critical (required)

Occurrence ratings are justified by data or history

Detection ratings reflect current control effectiveness critical (required)

RPN values are calculated correctly critical (required)

Yes No N/A

High-risk items are prioritized for action critical (required)

Yes No N/A

Action Plan and Follow-Up

Action items are defined for high-risk failure modes critical (required)

Yes No N/A

Each action item has an assigned owner

Yes No N/A

Due dates are realistic and documented

Yes No N/A

Planned actions address root cause or control gaps critical (required)

Yes No N/A

Effectiveness verification method is defined

Yes No N/A

Review Outcome

Overall PFMEA review status critical (required)

Reviewer comments

Reviewer signature critical (required)

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Run: Process FMEA Review Audit

PFMEA Document Control

Failure Mode and Effect Analysis

Risk Rating Validation

Action Plan and Follow-Up

Review Outcome

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