PPAP PFMEA Assessment and Process Risk Control

01How to use this chapter

This chapter separates the uploaded assessment criteria from practical KEVOS implementation guidance. The section titled Source-derived assessment criteria preserves the intent, terminology and checklist detail supplied in the uploaded PPAP Assessment. The surrounding handbook guidance explains how a manufacturing or supplier-quality team can organise evidence, perform a readiness review and spot gaps before formal submission. Where the uploaded source states a numeric threshold, edition reference or customer-specific expectation, it is identified as source-derived rather than presented as a universal rule.

Use the chapter in three passes. First, read the purpose and workflow to understand what the element is meant to prove. Second, work through the source-derived prompts against the actual part number, engineering revision and production process. Third, close the red flags and collect objective evidence before the package is released. For large PPAPs, record the evidence location beside each source prompt so another reviewer can repeat the assessment without relying on verbal explanation.

02Handbook workflow

1. Align PFMEA to the process flowUse the same process-step identities and ensure every normal, alternate and subcontract step that can affect product is assessed.
2. Bring design intent into process riskUse DFMEA and the confirmed special-characteristic lists so process risk analysis reflects product function and customer concerns.
3. Prioritise meaningful riskAddress top severity and occurrence concerns and the highest remaining risk priorities using executable actions rather than generic monitoring.
4. Prefer prevention and mistake-proofingThe source explicitly expects FMEA to drive process improvement with emphasis on error/mistake-proofing solutions.
5. Carry actions into the control systemFailure modes requiring action should create corresponding changes in the process, control plan, work instruction, gaging, maintenance, training or supplier controls.
6. Include subcontract riskIdentify special characteristics affected by subcontract suppliers, communicate them and verify that appropriate specific controls exist.
7. Recalculate and reviewComplete action-taken fields and updated risk values, then revisit PFMEA after product, design or process change and after customer problems.

03Evidence package to retain

The assessment is stronger when each conclusion points to a controlled record rather than a statement that the requirement is “covered”. The following evidence set is a practical minimum for this chapter; actual customer and contractual requirements govern the live submission.

• Approved PFMEA(s) with correct part number and engineering change
• Relevant tier-supplier PFMEA or evidence of their controlled risk process
• Confirmed special required/design/process characteristic lists
• Recommended-action register and action-taken evidence
• Cross-reference to process-flow steps
• Cross-reference to control-plan controls and reaction plans
• Evidence of trained cross-functional team participation
• Capability/SPC evidence for special characteristics
• Subcontract supplier characteristic communication and controls
• Revision/change history showing PFMEA is updated

04Source-derived assessment criteria

• 1.The supplier shall attach approved PFMEA(s).
• 2.Other design FMEAs shall be attached to fully cascade the product a. Product Vehicle b. System / Group Level c. Assembly Level d. Component Level
• 3.Are other tier suppliers PFMEA’s included?
• 4.If proprietary, is statement attached that DFMEA is available at supplier or to be presented at Organization upon request?
• 5.Is a list of recommended actions from the PFMEA attached?
• 6.Did the supplier attach a list of confirmed Special Required Characteristics?
• 7.Did the supplier attach a list of confirmed Special Design Characteristics?
• 8.Did the supplier attach a list of confirmed Special Process Characteristics?
• 9.Is the correct part number, engineering change and other info documented?
• 10.Are top Severity & Occurrence addressed with recommended actions?
• 11.Next in line, are the top RPNs addressed with recommended actions?
• 12.Are all Special Characteristics (Required, Design and Process) identified?
• 13.Is the PFMEA provided in English or translated?
• 14.Is there evidence that all print, specification, purchase order, attribute, etc. characteristics are included?
• 15.Are adequate controls in place for all characteristics?
• 16.Are special controls / actions in place for all Special Characteristics?
• 17.Does FMEA drive Process Improvements as the primary objective, with emphasis on Error/Mistake Proofing solutions?
• 18.Does FMEA address all high-risk Failure Modes, as identified by the FMEA team, with executable Action Plans?
• 19.All other failure modes are considered?
• 20.Is there evidence that the failure modes with action are carried over to the Process Control Plan??
• 21.Is Process FMEA integrated and consistent with the Process Flow Diagram, Process Control Plan and other APQP documents?
• 22.Is FMEA completed during the “window of opportunity” where it could most efficiently impact the design of the product or process?
• 23.Did the right people participate as part of the FMEA team throughout the analysis, and are adequately trained in the procedure?
• 24.Is FMEA document completely filled out “by the book,” including “Action Taken” and new RPN values?
• 25.Are recommended actions identified as required and the actions are implemented?
• 26.Are the criteria used to determine Special Characteristics documented?
• 27.Were the appropriate personnel involved in determining the Special Characteristics?
• 28.Has all dimensional tolerances and material properties been considered?
• 29.Was the design FMEA utilized to determine the Special Characteristics?
• 30.Have Special Characteristics been identified for all products?
• 31.Has warranty and reliability data been included to determine the characteristics?
• 32.Is there evidence that all known Special Characteristics were included?
• 33.Were attribute characteristics included?
• 34.Are New Product Introductions and design changes included in identifying Special Characteristics?
• 35.Is there clear linkage to PFMEA and other APQP documents?
• 36.Have all process dimensional tolerances and material properties been considered?
• 37.Are all Special Characteristics documented for this product?
• 38.Were Special Characteristics established for assembly and packing operations?
• 39.Have the Special Characteristics been included in all other PPAP documents?
• 40.Is there evidence of Statistical Process Control for all Special Characteristics or controls as identified and approved in the Control Plan?
• 41.Have capability studies been performed to validate the control of the characteristics?
• 42.Verify the Organization supplier quality performance indicators provide evidence that sufficient methods are in-place to monitor and control all characteristics.
• 43.Are there measurable quality improvement projects in place for Special Characteristics, where required?
• 44.Have the Special Characteristics affected by sub-contract supplier been identified?
• 45.Are Special Characteristics communication to the sub-contract suppliers?
• 46.Is there evidence that sub-contract suppliers have specific controls in place?

05Common red flags

These are practical review signals derived from the relationships and controls repeatedly required by the source. A red flag does not automatically mean the submission must be rejected; it means the condition deserves documented resolution before approval.

• PFMEA process steps do not match the actual flow
• Only the highest RPN is addressed while high severity remains untreated
• Actions say “operator training” without removing the underlying error mechanism
• Special characteristics are missing or use different symbols/identities across documents
• Action taken and new risk values are blank
• Alternate/subcontract process risk is omitted
• PFMEA was created after process design decisions were already fixed, with no evidence it influenced them
• Known customer problems are not fed back into the analysis

06Cross-document interfaces

PPAP elements should not be reviewed as isolated files. Check the following interfaces for consistent part identity, revision, characteristic naming, operation numbering and control logic.

07Assessor close-out checklist

• The element is present or a controlled waiver/agreement explains why it is not required.
• The submitted record identifies the correct part number and engineering revision where applicable.
• The evidence is legible, understandable, controlled and traceable to the submitted product/process.
• Special characteristics and known customer concerns are treated consistently across related documents.
• Any nonconformance, temporary control, deviation or interim condition is visible and formally dispositioned.
• Actions have owners, due dates and objective closure evidence where the source expects corrective action.
• The final conclusion can be independently repeated by another reviewer using the package alone.

08Frequently asked questions

09Source and limitations

Primary source: uploaded Production Part Approval Process (PPAP) Assessment / PPAP Submission Assessment, 15 pages, Quality-One. Source sections used on this page: 2.2.6 Process Failure Mode and Effects Analysis. Approximate source page coverage: 5-6.

This KEVOS chapter is an educational and assessment aid. It preserves the uploaded document's criteria but does not replace controlled customer-specific requirements, engineering specifications, contractual requirements or an official PPAP/APQP manual. Where the source references “PPAP 4th edition”, AIAG methods, Organization systems or Organization-specific targets, those references are retained as source context rather than silently updated or generalized.