Polaroid验厂-设计控制

Polaroid验厂之设计控制要求（英）：

1.  Are there procedures to control, review, verify, and validate the design of the product to ensure it is meeting all requirements?

2.  Are there plans that identify the responsibility for each design and development activity?

3.  Are the plans updated as the design evolves?

4.  Are obsolete design documents removed from the application area?

5.  Are the design and verification activities planned and assigned to qualified design personnel?

6.  Does Project Manager have adequate management skills where we could see from the project schedule is on track with the planned milestones (e.g., Engineering sample, working sample, pilot run, PP, MP)?

7.  Are organizational and technical interfaces between different groups identified, documented, transmitted and reviewed regularly?

8.  Are design input requirements relating to the product identified, records maintained and reviewed for adequacy?

9.  Is there a procedure for resolving incomplete or conflicting requirements with those responsible for drawing up the requirements?

10.  Are design outputs documented and expressed in terms of requirements, calculations and analyses?

11.  Has the supplier established Phase Review Process to verify the design effectiveness throughout the entire development cycle till mass production?

12.  Are there quantifiable measurements defined for phase exit/entry criteria?

13.  Have the above criteria been verified and confirmed with documented data/report with adequate results?

14.  Has the design verification been planned, established, documented and assigned to competent verification personnel?

15.  Does the supplier own enough test equipment/tools and procedures for design verification to ensure the design output meet the design input?

16.  Are there procedures for the identification, documentation, review and approval of all changes and modifications?

17.  Is there a requirement to verify the product meets design specifications prior to mass production? (e.g., design review/verification)

18.  Are the records for design control, review, verification, and validation properly documented and maintained

19.  Does design review included the inputs from related departments/parties?

Polaroid/宝丽来验厂之设计控制要求（中）：

1. 有程序来控制，评审，验证产品的设计以确保它满足所有要求？

2. 是否有计划程序，确定每个设计和开发活动的职责？

3. 规划设计是否随着发展而更新？

4. 是否从应用领域中删除过时的设计文件？

5. 设计和验证活动计划是否并分配给有资格的设计人员？

6. 项目经理是否有足够的管理能力，我们可以从项目进度看轨道上的计划里程碑（例如，工程样品，采样工作，试点运行，PP，MP）？

7. 定期复查不同群体之间的组织和技术接口的识别，记录和传播？

8. 是否对所确定的产品设计要求保持记录和适当性审查？

9. 对于那些不完整或相互矛盾的制定要求是否有解决程序？

10. 设计输出文件的相关要求，计算和分析

11. 在整个开发周期到批量生产中供应商是否有建立阶段评审过程来验证设计的有效性？

12. 定义阶段有可量化的度量退出/进入标准吗?

13. 以上的标准，验证和记录的数据/报告是否有适当的结果证实？

14. 设计验证计划，建立，记录和分配给主管审核人员？

15. 供应商是否拥有足够的测试设备/工具和程序设计验证，以确保设计输出满足设计输入？

16. 是否有程序来识别，记录，所有的变更和修改审核批准？

17. 批量生产之前是否有一个程序确认产品符合设计的规格？（例如，设计评审/验证）

18. 设计控制评审，验证和确认是否有适当的记录和维护？

19. 设计评审是否包括来自相关部门/机构的参与？