Are Initial Process Capability study available for all Critical Characteristics ( KPC & PQC )? 11. Initial Process Studies If no Critical Characteristics, are features called out by customer available ? Are the capability results within specification for initial capability study ? 12. Qualified Laboratory Do all third-party laboratories conform to ISO/IEC 17025 or equivalent? Doc. 13. Appearance Approval Report, if applicable Is a separate Appearance Approval Report completed ? Is the Appearance Approval Report approved ?
Do the results represent all manufacturing processes, cells, cavities and molds? 9. Dimensional Results Are all dimensions (except reference dimensions), characteristics and specifications recorded (min 5 parts)? Is there a copy of the drawing with each dimension, test, and or specification identified with a unique number?
Are all gages approved? 8. MSA Are the gage R&R studies conducted? (Repeatability & Reproductibility studies) Variable gauge study - Ensure that the gauge R&R is acceptable (<10%= measurement system is acceptable, 10-30%= measurement system may be acceptable based upon KCDS / FMEA severity )
14. Sample Product
Has 2 (default) sample parts been submitted (check need for Matching parts)?
Is a Master Sample available for all cavities (when applicable)? 15. Master Sample Is the Master Sample approved? Are the Master Samples correctly identified and stored?
5. Process Flow Diagrams
Does the Process Flow Diagram exist for all process steps starting from incoming inspection until finished parts incl all sub-processes, transports, handling, rework and scrap flow? Are all critical characteristics clearly identified in the Process Flow Diagram? Is there a link to FMEA and Control Plan?
10. Material, Performance Test Results
Are all Validation tests completed according to VAP and signed by Design resp. ? Are all records of material results approved? (IMDS - MDS report ). When applicable, is CCC approved (Chinese certification) ?
PPAP
Topic 1. Design Record 2. Engineering Change Documents, if any Copy of latest specification(s). Check items Comment
Specifications incorporated on Product but not yet i. Part Submission Warrant (PSW)
Is Part Submission Warrant filled in in a correct way? If PSW signed off as interim PPAP, is there an approved Part deviation request?
Is PFMEA according to AIAG FMEA Handbook? Is there a clear link to the DFMEA? 6. Process FMEA Is there a clear link to the Process Flow Diagram and Control Plan? Are all special process controls (if applicable) identified? Are the critical characteristics identified? Are actions identified to eliminate Severity, reduced Occurence and increased Detection?
16. Checking Aids
Is a list available for all equipment available?
17. Records of compliance with Specific When applicable, specific requirements and results are to be documented and verified. Requirements
3. Customer Engineering Copy of Design Approval / Design Validation Approval Only for Development Suppliers Approval
Is DFMEA according to the AIAG FMEA Handbook? 4. Design FMEA (Design Development Suppliers) Are potential critical characteristics identified? Are actions identified to eliminate Severity, reduce Occurence and increase Detection?
Is the Control Plan according to AIAG APQP and Control Plan Handbook? Is there a clear link to the Process Flow Diagram and PFMEA? 7. Control Plan Are all special process controls (if applicable) identified? Are the critical characteristics listed? Are all critical characteristics transferred into the Operator instructions?