Change Control Statement Sample Clauses

Change Control Statement. Supplier will not make any change to the product, process, materials, formulation, packaging, labeling, software, environment conditions, quality assurance processes, equipment, production location or subcontractor that could in anyway affect the quality of the finished device, without prior written notification and where appropriate, approval from Stryker. [Redacted** (24 pages)] Scope: Development & Manufacturing Responsibilities Name Signature Date Revision: 1 Status: o in Process o Released Distribution: STRYKER INSTRUMENTS R&D AME Materials SQE QA/RA Distribution: SUPPLIER QA/RA Manufacturing Other __________ Other _______________ QA/RA Reviewed & Approved: Name: Signature: Date: Manufacturing Reviewed & Approved: Name: Signature: Date: Other __________: Reviewed & Approved: Name: Signature: Date: Other __________: Reviewed & Approved: Name: Signature: Date: R&D Reviewed & Approved: Name: Signature: Date: QA/RA Reviewed & Approved: Name: Signature: Date: Manufacturing Reviewed & Approved: Name: Signature: Date: Supplier Quality Reviewed & Approved Name: Signature: Date: Materials/Purchasing Reviewed & Approved: Name: Signature: Date: Rev. Nr. Comments Date Author 1 Goals/Objectives 2 3 Manufacturing Requirements 3 4 Packaging Requirements 11 5 Purchase Orders 11 6 Order Acknowledgement 11 7 Delivery Documentation 11 8 Delivery Rejection 12 9 Product/Process Changes 12 10 Financial Responsiblities 13 11 Record Retention 13 12 Formal Problem-Solving 14 13 Quality Performance Expectations 15 14 Contact Information 15 1 Goals/Objectives