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PFMEA Document Control

PFMEA identifies the correct process, product, and scope critical (required)

Yes No N/A

Document revision, date, and owner are clearly listed

Yes No N/A

Cross-functional review team is documented

Yes No N/A

PFMEA is linked to the current process flow diagram and control plan critical (required)

Yes No N/A

Required customer, regulatory, or internal requirements are reflected

Yes No N/A

Failure Mode and Effect Analysis

Failure modes are specific, observable, and process-step aligned critical (required)

Yes No N/A

Effects of failure are documented at the process, downstream, and customer level

Yes No N/A

Causes are identified and tied to the failure mode

Yes No N/A

Current prevention and detection controls are listed for each cause critical (required)

Yes No N/A

Special characteristics or critical process steps are identified where applicable

Yes No N/A

Risk Rating Validation

Severity ranking is assigned using the approved ranking scale critical (required)

Occurrence ranking is assigned using the approved ranking scale critical (required)

Detection ranking is assigned using the approved ranking scale critical (required)

RPN is calculated correctly from severity, occurrence, and detection critical (required)

Yes No N/A

High-risk items are prioritized for action based on the organization’s threshold

Yes No N/A

Action Plan and Follow-Up

Recommended actions are specific and linked to the relevant failure mode critical (required)

Yes No N/A

Action owner and due date are assigned for each open item critical (required)

Yes No N/A

Action status is current and overdue items are identified

Yes No N/A

Residual risk is reassessed after action implementation

Yes No N/A

Evidence of closure is attached or referenced for completed actions

Yes No N/A

Review Outcome

Overall PFMEA review result critical (required)

Note (optional)

Summary of deficiencies and required follow-up actions

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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

Get your results