Polaroid驗廠之設計控制要求（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/寶麗來驗廠之設計控制要求（中）：

1. 有程序來控制，評審，驗證產(chǎn)品的設計以確保它滿足所有要求？

2. 是否有計劃程序，確定每個設計和開發(fā)活動的職責？

3. 規(guī)劃設計是否隨著發(fā)展而更新？

4. 是否從應用領域中刪除過時的設計文件？

5. 設計和驗證活動計劃是否并分配給有資格的設計人員？

6. 項目經(jīng)理是否有足夠的管理能力，我們可以從項目進度看軌道上的計劃里程碑（例如，工程樣品，采樣工作，試點運行，PP，MP）？

7. 定期復查不同群體之間的組織和技術(shù)接口的識別，記錄和傳播？

8. 是否對所確定的產(chǎn)品設計要求保持記錄和適當性審查？

9. 對于那些不完整或相互矛盾的制定要求是否有解決程序？

10. 設計輸出文件的相關(guān)要求，計算和分析

11. 在整個開發(fā)周期到批量生產(chǎn)中供應商是否有建立階段評審過程來驗證設計的有效性？

12. 定義階段有可量化的度量退出/進入標準嗎?

13. 以上的標準，驗證和記錄的數(shù)據(jù)/報告是否有適當?shù)慕Y(jié)果證實？

14. 設計驗證計劃，建立，記錄和分配給主管審核人員？

15. 供應商是否擁有足夠的測試設備/工具和程序設計驗證，以確保設計輸出滿足設計輸入？

16. 是否有程序來識別，記錄，所有的變更和修改審核批準？

17. 批量生產(chǎn)之前是否有一個程序確認產(chǎn)品符合設計的規(guī)格？（例如，設計評審/驗證）

18. 設計控制評審，驗證和確認是否有適當?shù)挠涗浐途S護？

19. 設計評審是否包括來自相關(guān)部門/機構(gòu)的參與？