Polaroid验厂-文件控制

Polaroid/宝丽来验厂-文件控制

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

   (a) a Quality Manual? 质量手册？

   (b) Procedures to support Quality System defined in Quality Manual ?
       质量体系的程序支持定义的质量手册？

   (c) Design documents and technical spec./ drawings? 设计文件和技术规范/图纸？

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

   (e) Work instructions? 作业指导书？

   (f) Audit documents? 审核文件？

2. Have the procedures and work instructions been consistently and effectively implemented?
   这些程序和工作指南是否一致和有效的执行？

3. Are there documents to specify the guidelines for design doc./ technical spec. drawings/ process control doc./ procedure and W/I preparation?
   是否有文件规定设计指导方针。/技术规格图纸/过程控制/程序？

4. Does the document control procedure ensure that relevant versions of applicable documents are available at points of use?
   文件控制程序是否确保适用文件的有关版本在使用时可获得？

5. Does the procedure ensure that documents remain legible, readily identifiable?
   是否有程序控制来确保文件保持清晰，易于识别？

6. Does the procedure ensure that documents of external origin are identified and the distribution controlled?
   是否有程序确保外来文件得到识别和分布的控制？

7. Does the procedure ensure that all obsolete documents are promptly removed from all points of issue or use?
   是否有程序确保所有作废的文件及时从所有发放处或使用中删除？

8. Does the procedure ensure suitable identification of obsolete documents if they are retained for any purpose ?
   如果因某种需要而保留的作废文件是否标有适当的标识？

9. If paperless documents used, does the system ensure that their version, identification, storage and distribution are well controlled?
   如果使用无纸化文件，系统是否能确保他们的版本，识别，储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?
   质量文件在发布前是否经授权人员审查和批准？

11. Is there a procedure to govern engineering changes? 是否有一个程序来管理工程变更？

12. Are engineering changes reviewed and approved by authorized personnel prior to implementation?
    工程变更在执行前是否被授权人员审查和批准？

13. Are the engineering change notifications distributed to all affected functional areas once approved?
    如果有工程变更通知一旦批准是否分发到所有受影响的地区？

14. Is there a system to ensure engineering change notifications are being implemented?
    是否有程序来确保工程变更通知被执行？

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?
    是否有程序文件来验证和反馈工程变更的有效性

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