DesignTransfer关于设计移交的介绍.docVIP

[Company Name] [Company Group, Division, Location] Document Title: Design Transfer Document Number: [Document Number] Document Filename: [Document Filename] CONTROLLED COPY/ MASTER COPY STAMP HERE OTHER STAMP HERE Revision Level Revision Date DCO/ECO Number Description of Revision Revision Author DRAFT DD/MM/YY YY-00000 Draft Author Name 1.00 DD/MM/YY YY-00000 Initial Release Author Name Table of Contents 1.0 Purpose 2 2.0 Scope 2 3.0 Definitions 2 3.1 Design History File (DHF) 2 3.2 Design Input 2 3.3 Design Output 2 3.4 Design Validation 2 3.5 Device Master Record (DMR) 2 3.6 Final Product Development Review 2 3.7 Pilot Production 2 3.8 Product 2 3.9 Production Specifications 2 3.10 Product Development 2 3.11 Quality 3 3.12 Quality System 3 3.13 Specification 3 3.14 Validation 3 3.15 Verification 3 4.0 Responsibilities and Requirements 3 4.1 Executive Management Team (EMT) 3 4.2 Product Manager 3 4.3 Regulatory Affairs/Quality Systems Director 3 5.0 References 3 6.0 Procedure 4 6.1 Objective of Design Transfer 4 6.2 Number of Final Product Development Reviews 4 6.3 Conducting Final Product Development Reviews 4 6.4 Documenting Design Transfer 4 Purpose This procedure defines the process for ensuring that the product design is correctly translated into Production Specifications and properly transferred to Manufacturing. Scope This procedure applies to all product development programs funded and managed by [Company Name]. Definitions Design History File (DHF) A compilation of records, which describes the design history of a finished product. Design Input The physical and performance requirements of a product used as a basis for product design and development. Design Output The results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the Device Master Record. The total finished design output consists of the product, its packaging