Arthrex expects a Certificate of Compliance to accompany each package with every shipment. The Certificate of Compliance certifies that all parts were manufactured and inspected to the purchase order and drawing specifications and all materials and processes conform to the manufacturing specification listed on the drawing. Special process certifications are also required for any special processes performed by an outsourced vendor.
Arthrex expects the Certificate of Compliance to include a minimum of:
- Packing list number
- Purchase order number
- Quantity shipped
- Part number
- Part name
- Revision
- Lot/batch number
- Country of origin (COO)
- For material that has a laser etch, both lot number and laser etch number
- Batch numbers and quantity for subcontract purchase order subcomponant, if applicable
- Statement of conformance for any critical characteristics, if applicable
- Test data for each AQL sample, if applicable
- Certificate of analysis results when required per drawing, if applicable
- Certificate should state FAIR is included, if applicable
- Signature and date from reviewer