Polaroid/寶麗來驗廠-文件控制

1. Does the supplier have established and documented procedures for 供應商是否有建立成文件的控制程序

   (a) a Quality Manual? 質(zhì)量手冊？

   (b) Procedures to support Quality System defined in Quality Manual ?
       質(zhì)量體系的程序支持定義的質(zhì)量手冊？

   (c) Design documents and technical spec./ drawings? 設計文件和技術規(guī)范/圖紙？

   (d) Process control documents? 過程控制文件？

   (e) Work instructions? 作業(yè)指導書？

   (f) Audit documents? 審核文件？

2. Have the procedures and work instructions been consistently and effectively implemented?
   這些程序和工作指南是否一致和有效的執(zhí)行？

3. Are there documents to specify the guidelines for design doc./ technical spec. drawings/ process control doc./ procedure and W/I preparation?
   是否有文件規(guī)定設計指導方針。/技術規(guī)格圖紙/過程控制/程序？

4. Does the document control procedure ensure that relevant versions of applicable documents are available at points of use?
   文件控制程序是否確保適用文件的有關版本在使用時可獲得？

5. Does the procedure ensure that documents remain legible, readily identifiable?
   是否有程序控制來確保文件保持清晰，易于識別？

6. Does the procedure ensure that documents of external origin are identified and the distribution controlled?
   是否有程序確保外來文件得到識別和分布的控制？

7. Does the procedure ensure that all obsolete documents are promptly removed from all points of issue or use?
   是否有程序確保所有作廢的文件及時從所有發(fā)放處或使用中刪除？

8. Does the procedure ensure suitable identification of obsolete documents if they are retained for any purpose ?
   如果因某種需要而保留的作廢文件是否標有適當?shù)臉俗R？

9. If paperless documents used, does the system ensure that their version, identification, storage and distribution are well controlled?
   如果使用無紙化文件，系統(tǒng)是否能確保他們的版本，識別，儲存和分配得到很好的控制？

10. Are quality documents reviewed and approved for adequacy by authorized personnel prior to issue?
   質(zhì)量文件在發(fā)布前是否經(jīng)授權人員審查和批準？

11. Is there a procedure to govern engineering changes? 是否有一個程序來管理工程變更？

12. Are engineering changes reviewed and approved by authorized personnel prior to implementation?
    工程變更在執(zhí)行前是否被授權人員審查和批準？

13. Are the engineering change notifications distributed to all affected functional areas once approved?
    如果有工程變更通知一旦批準是否分發(fā)到所有受影響的地區(qū)？

14. Is there a system to ensure engineering change notifications are being implemented?
    是否有程序來確保工程變更通知被執(zhí)行？

15. Is there a system to ensure engineering change is implemented only after needed training/ tools & equipment provided and W/I updated?


16. Is there a system to verify and feedback the effectiveness of engineering changes?
    是否有程序文件來驗證和反饋工程變更的有效性

17. Is cycle time and process defined for red line document (e.g. handwriting document) control?