Arthrex requires category A and B contract manufacturer suppliers to submit PPAP evidence for any new production part. PPAP may also be required in other scenarios as required by your Global Supplier Quality representative.
The purpose of the PPAP is to:
- Provide evidence that all Arthrex engineering design records and specification requirements are properly understood by the manufacturer
- Demonstrate that the manufacturing process has the potential to produce parts consistently meeting these requirements during an actual production run
As part of the PPAP plan, the Arthrex Supplier Quality Engineer (SQE) will complete the PPAP Initiation Form and submit it to the supplier. This form will outline the elements of the PPAP that the supplier will be required to submit to the SQE. The supplier then submits the signed PPAP Initiation Form, completes the required elements of the PPAP, and provides all evidence along with the Part Submission Warrant (PSW) to the SQE. Once the SQE has reviewed and found all submission documents acceptable, approval will be granted for full production.
The possible elements of a PPAP may include, but are not limited to:
- Process flow diagram
- PFMEA (Process Failure Mode and Effect Analysis)
- Control Plan/inspection Plan
- MSA (Measurement System Analysis)
- Dimensional results/FAIR
- Performance test records
- Capability studies
- Validation/process studies
- Material analysis (C of A)
- Certificate of Conformance (C of C)
- Declaration of Hazardous Substances
- Sample production label