Polaroid驗(yàn)廠之設(shè)計(jì)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(lái)驗(yàn)廠之設(shè)計(jì)控制要求（中）：

1. 有程序來(lái)控制，評(píng)審，驗(yàn)證產(chǎn)品的設(shè)計(jì)以確保它滿足所有要求？

2. 是否有計(jì)劃程序，確定每個(gè)設(shè)計(jì)和開(kāi)發(fā)活動(dòng)的職責(zé)？

3. 規(guī)劃設(shè)計(jì)是否隨著發(fā)展而更新？

4. 是否從應(yīng)用領(lǐng)域中刪除過(guò)時(shí)的設(shè)計(jì)文件？

5. 設(shè)計(jì)和驗(yàn)證活動(dòng)計(jì)劃是否并分配給有資格的設(shè)計(jì)人員？

6. 項(xiàng)目經(jīng)理是否有足夠的管理能力，我們可以從項(xiàng)目進(jìn)度看軌道上的計(jì)劃里程碑（例如，工程樣品，采樣工作，試點(diǎn)運(yùn)行，PP，MP）？

7. 定期復(fù)查不同群體之間的組織和技術(shù)接口的識(shí)別，記錄和傳播？

8. 是否對(duì)所確定的產(chǎn)品設(shè)計(jì)要求保持記錄和適當(dāng)性審查？

9. 對(duì)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(shè)計(jì)輸出文件的相關(guān)要求，計(jì)算和分析

11. 在整個(gè)開(kāi)發(fā)周期到批量生產(chǎn)中供應(yīng)商是否有建立階段評(píng)審過(guò)程來(lái)驗(yàn)證設(shè)計(jì)的有效性？

12. 定義階段有可量化的度量退出/進(jìn)入標(biāo)準(zhǔn)嗎?

13. 以上的標(biāo)準(zhǔn)，驗(yàn)證和記錄的數(shù)據(jù)/報(bào)告是否有適當(dāng)?shù)慕Y(jié)果證實(shí)？

14. 設(shè)計(jì)驗(yàn)證計(jì)劃，建立，記錄和分配給主管審核人員？

15. 供應(yīng)商是否擁有足夠的測(cè)試設(shè)備/工具和程序設(shè)計(jì)驗(yàn)證，以確保設(shè)計(jì)輸出滿足設(shè)計(jì)輸入？

16. 是否有程序來(lái)識(shí)別，記錄，所有的變更和修改審核批準(zhǔn)？

17. 批量生產(chǎn)之前是否有一個(gè)程序確認(rèn)產(chǎn)品符合設(shè)計(jì)的規(guī)格？（例如，設(shè)計(jì)評(píng)審/驗(yàn)證）

18. 設(shè)計(jì)控制評(píng)審，驗(yàn)證和確認(rèn)是否有適當(dāng)?shù)挠涗浐途S護(hù)？

19. 設(shè)計(jì)評(píng)審是否包括來(lái)自相關(guān)部門(mén)/機(jī)構(gòu)的參與？