Process FMEA Failure Mode Review Checklist [FREE PDF]

Process Failure Mode and Effects Analysis (PFMEA) is a structured analytical tool required by IATF 16949:2016 Clause 10.2.3 and mandated by the AIAG & VDA FMEA Handbook (2019) for automotive suppliers to proactively identify and mitigate process failure modes before they impact the customer. This checklist supports quality engineers and process teams in conducting rigorous PFMEA reviews, evaluating Risk Priority Numbers (RPNs) or Action Priority (AP) ratings, and verifying that corrective action

  • Industry: Automotive
  • Frequency: Per Event
  • Estimated Time: 60-90 minutes
  • Role: Process Engineer
  • Total Items: 42
  • Compliance: IATF 16949:2016 Clause 10.2.3 - Problem solving, IATF 16949:2016 Clause 8.5.1.1 - Control plan, ISO 9001:2015 Clause 8.5 - Production and service provision, AIAG & VDA FMEA Handbook 1st Edition 2019 - Action Priority method, AS9100 Rev D Clause 8.4 - Control of externally provided processes

PFMEA Document Control and Setup

Verify that the PFMEA document is properly controlled, current, and linked to the correct process.

  • Is the PFMEA document controlled under the document management system with a current revision?
  • Does the PFMEA header contain all required fields including part number, process name, model year, and responsible engineer?
  • Is the PFMEA linked to the associated control plan and process flow diagram?
  • Has the cross-functional team (CFT) been documented and are all relevant functions represented?
  • Attach or photograph the current PFMEA title block / header page.

Process Scope and Structure Analysis

Confirm that the PFMEA scope is complete and that all process steps are systematically covered.

  • Does the PFMEA cover all manufacturing process steps identified in the process flow diagram?
  • Are sub-processes and work element levels defined within the structure analysis?
  • Are transfer steps, inspection operations, and rework operations included in the PFMEA scope?
  • Is the process step structure aligned with the most recent process flow diagram revision?
  • How many total process steps are covered in this PFMEA?

Failure Mode and Function Analysis

Evaluate the completeness and accuracy of function, requirement, and failure mode identification.

  • Is a clear process function and requirement (intent) defined for each process step?
  • Are failure modes described as the opposite or negation of the process function?
  • Are multiple failure modes identified per process step where applicable?
  • Are failure effects documented at the next higher level and the end customer/vehicle level?
  • Are failure causes identified with sufficient specificity to drive meaningful corrective actions?
  • Are safety-related failure modes explicitly flagged with appropriate severity indicators?

Severity, Occurrence, and Detection Rating Review

Verify that SOD ratings are assigned consistently using the defined evaluation criteria.

  • Are Severity (S) ratings assigned using the approved AIAG & VDA or customer-specific rating scale?
  • Are Occurrence (O) ratings based on actual process data, historical failure rates, or validated estimates?
  • Are Detection (D) ratings reflective of the ability of current process controls to detect the failure cause or mode?
  • Have Action Priority (AP) ratings or RPN thresholds been established and applied to all failure modes?
  • What is the total number of failure modes currently rated as Action Priority High (AP-H) or RPN above threshold?
  • Are ratings peer-reviewed and approved by the cross-functional team before being finalized?

Current Process Controls Assessment

Confirm that prevention and detection controls are accurately documented and reflect actual practice.

  • Are prevention controls (PC) and detection controls (DC) listed separately for each failure cause?
  • Do listed controls match the controls actually implemented on the shop floor and documented in the control plan?
  • Are error-proofing (poka-yoke) devices referenced in the PFMEA where applicable?
  • Are statistical process control (SPC) requirements referenced for critical characteristics in the PFMEA?
  • Are control effectiveness validations or results referenced to support assigned Detection ratings?

Recommended Actions and Corrective Action Tracking

Review the status and effectiveness of actions taken to reduce high-priority failure modes.

  • Are recommended actions defined for all failure modes rated Action Priority High (AP-H) or exceeding RPN threshold?
  • Is each recommended action assigned to a responsible person with a defined target completion date?
  • Have completed actions been verified for effectiveness and resulted in updated SOD ratings?
  • What percentage of open recommended actions are past their target completion date?
  • Are lessons learned from past nonconformances and field returns incorporated as new failure modes or updated ratings?

Special Characteristics and High-Severity Review

Verify that special characteristics and safety-critical failure modes receive mandatory review and action.

  • Are all special characteristics (SC) identified in the design record reflected in the PFMEA?
  • Do all failure modes with Severity = 9 or 10 have documented mandatory special actions regardless of Action Priority rating?
  • Is there documented evidence of management review and approval for Severity = 9 or 10 failure modes?
  • Are customer-specific symbols or designations for special characteristics correctly applied throughout the PFMEA?
  • Provide any additional reviewer observations, open issues, or recommendations for PFMEA improvement.

PFMEA Maintenance and Continual Improvement

Confirm that the PFMEA is maintained as a living document and reviewed at defined trigger events.

  • Is there a documented procedure defining when the PFMEA must be updated (trigger events)?
  • Has the PFMEA been updated following any engineering changes, process changes, or quality escapes since the last review?
  • Is there evidence that warranty or field return data has been reviewed for potential PFMEA updates?
  • Is the PFMEA review frequency aligned with the organization's risk management and product lifecycle requirements?
  • Attach a photograph of the PFMEA open action item log or tracking sheet.

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Why Use This Process FMEA Failure Mode Review Checklist [FREE PDF]?

This process fmea failure mode review checklist [free pdf] helps automotive teams maintain compliance and operational excellence. Designed for process engineer professionals, this checklist covers 42 critical inspection points across 8 sections. Recommended frequency: per event.

Ensures compliance with IATF 16949:2016 Clause 10.2.3 - Problem solving, IATF 16949:2016 Clause 8.5.1.1 - Control plan, ISO 9001:2015 Clause 8.5 - Production and service provision, AIAG & VDA FMEA Handbook 1st Edition 2019 - Action Priority method, AS9100 Rev D Clause 8.4 - Control of externally provided processes. Regulatory-aligned for audit readiness and inspection documentation.

Frequently Asked Questions

What does the Process FMEA Failure Mode Review Checklist [FREE PDF] cover?

This checklist covers 42 inspection items across 8 sections: PFMEA Document Control and Setup, Process Scope and Structure Analysis, Failure Mode and Function Analysis, Severity, Occurrence, and Detection Rating Review, Current Process Controls Assessment, Recommended Actions and Corrective Action Tracking, Special Characteristics and High-Severity Review, PFMEA Maintenance and Continual Improvement. It is designed for automotive operations and compliance.

How often should this checklist be completed?

This checklist should be completed per event. Each completion takes approximately 60-90 minutes.

Who should use this Process FMEA Failure Mode Review Checklist [FREE PDF]?

This checklist is designed for Process Engineer professionals in the automotive industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.

Can I download this checklist as a PDF?

Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.

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