Process FMEA Review Audit

An inspection template for reviewing Process FMEA (PFMEA) documents, including severity, occurrence, detection, RPN, and action item tracking.

PFMEA Document Control

• PFMEA identifies the correct process, product, and scope
• Document revision, date, and owner are clearly listed
• Cross-functional review team is documented
• PFMEA is linked to the current process flow diagram and control plan
• Required customer, regulatory, or internal requirements are reflected

Failure Mode and Effect Analysis

• Failure modes are specific, observable, and process-step aligned
• Effects of failure are documented at the process, downstream, and customer level
• Causes are identified and tied to the failure mode
• Current prevention and detection controls are listed for each cause
• Special characteristics or critical process steps are identified where applicable

Risk Rating Validation

• Severity ranking is assigned using the approved ranking scale
• Occurrence ranking is assigned using the approved ranking scale
• Detection ranking is assigned using the approved ranking scale
• RPN is calculated correctly from severity, occurrence, and detection
• High-risk items are prioritized for action based on the organization’s threshold

Action Plan and Follow-Up

• Recommended actions are specific and linked to the relevant failure mode
• Action owner and due date are assigned for each open item
• Action status is current and overdue items are identified
• Residual risk is reassessed after action implementation
• Evidence of closure is attached or referenced for completed actions

Review Outcome

• Overall PFMEA review result
• Summary of deficiencies and required follow-up actions