Document List - QMS - Chinese Version - Rev 01 - 18Nov2014

1、1.1. ManagementManagement OperationOperation OfficeOffice管管理理运运行行办办公公室室Clause #条条款款号号2.12.22.33.1.13.2.13.2.23.3.13.3.23.3.33.4.13.4.23.5.13.9.13.9.23.11.13.11.24. 3. 14. 6. 15. 1. 15. 1. 22. Raw Material Warehouse原原材材料料仓仓库库ClauseClause # #条条款款号号1.3.33.7.13.7.23.8.13.8.33.8.43.10.13.11.23. 5. 24. 3.

2、 14. 3. 24. 3. 34. 4. 14. 5. 14. 5. 36. 1. 13. Production- Line生生产产线线ClauseClause # #条条款款号号1.3.31.7.11.7.21.7.51.7.63.8.13.10.13.11.24. 3. 24. 5. 14. 5. 24. 5. 35. 2. 25. 2. 35. 2. 46. 2. 47. 2. 24.4. QCQC & & ComplianceCompliance DeptDept质质量量控控制制& &合合规规性性部部门门ClauseClause # #条条款款号号1.

3、7.11.7.21.7.31.7.41.7.63.6.13.6.23.7.13.7.23.8.53.9.33.12.14. 1. 14. 5. 24. 6. 15. 2. 25. 2. 35. 2. 45. 3. 15. 4. 27. 1. 37. 2. 15.5. PackagingPackaging / / FinishingFinishing包包装装/ /加加工工ClauseClause # #条条款款号号1.3.31.7.43.8.13. 10. 13.11.24. 4. 14. 4. 24. 5. 35. 3. 15. 4. 26.6. FinishedFinished Produc

4、tProduct WarehouseWarehouse成成品品仓仓库库ClauseClause # #条条款款号号1. 3. 34. 3. 27.7. ShippingShipping运运输输ClauseClause # #条条款款号号3. 8. 33. 8. 48.8. LaboratoryLaboratory实实验验室室Clause #条条款款号号5. 1. 16. 2. 16. 2. 26. 2. 37. 1. 29.9. MachineMachine MaintenanceMaintenance机机器器维维护护ClauseClause # #条条款款号号1. 4. 16. 2. 16.

5、 2. 26. 2. 36. 2. 410.10. PestPest ControlControl虫虫害害控控制制ClauseClause # #条条款款号号1. 5. 11. 5. 21. 5. 311.11. WasteWaste DisposalDisposal废废物物处处理理ClauseClause # #条条款款号号1. 6. 11. 6. 212.12. ChemicalChemical ControlControl化化学学品品控控制制ClauseClause # #条条款款号号4. 2. 14. 2. 24. 2. 313.13. HRHR人人力力资资源源ClauseClause

6、 # #条条款款号号7. 1. 17. 2. 17. 2. 214.14. TrainingTraining培培训训ClauseClause # #条条款款号号7. 1. 3Quality Management System FA - 质质量量管管理理系系统统审审核核 - Document List by Location 文文件件列列表表Vesion 09 06Oct2014第第9版版 2014年年10月月6日日Management Operation OfficeFactory: 工厂Document 文文件件名名称称_1. CAP of a previous audit 以前审核的纠正措

7、施计划_1. Written Procedure showing for managing and communicatingpotential late delivery with clients_2. KPI measuring on-time delivery performances. _1.管理和客户沟通潜在延迟交货的程序_ 2.按时交付的出货统计. _1. Quality Improvement Meeting Recap_2. Procedures for quality improvement process_1.质量改进会议总结_2.质量改进的程序_1. Quality Ma

8、nual_1.质量手册_1. Quality Policy_1.质量方针_1. Management Memo/ E-mails on Quality Policy Statement_2. Attendance Record for Employee Orientation on CompanyPolicy_3. Meeting Agenda on Company Policy between Management& Employees._1.质量方针传递沟通的证据：管理备忘录和电子邮件_2.公司政策培训的员工出勤记录_3.公司管理层和员工之间的公司政策会议议程.1.1. Manag

9、ementManagement OperationOperation OfficeOffice管管理理运运行行办办公公室室_1. JD of Manager/Supervisor Responsible_ Production Dept._ QA Dept._Finishing Dept._ Shipping Department_Others, pls specify_2. Organization Chart_3. Written Procedure on the accountability公司的经理/主管的岗位职责描述_生产部_质量部_加工部_运输部_其他，请注明_2.组织结构图_3.

10、 书面的管理权限要求_1. Organizational Chart_2. Job description of Manager/Supervisor and workerInterviewed_1.组织结构图_2.受访经理/主管和工人的岗位职责描述_1. Most updated development, legislation and codes ofpractice (i.e.; CPSIA, EN 581 -1 , EN 581-2 , etc.) applicable toproduct being produced and to following countries of des

11、tination._ EU_ America_Asia/Japan_2. Updated legislation information for the existing product in thefactory for at least 2 countries of destination_ EU_ America_Asia/Japan._1适用于产品的生产国和销售国最新的法规和实施规范文件（即；CPSIA，EN 581 - 1，EN 581-2，等）_欧盟_美国_亚洲 /日本_2 工厂现有产品至少适合2个销售国家的新立法信息_欧盟_美国_亚洲 /日本. _1. Procedure use

12、d by staffs to obtain clients order, requirement,and how it is communicated down to the workers._2. Customer Satisfaction KPI_1.内/部信息交流沟通程序._2.顾客满意指标_1. Specifications for raw materials_2. Specifications for Semi-finished Products_3. Specifications for finished products_1.原材料的规格_2.半成品的规格_3.成品的规格 _1.

13、 Management System Review Procedure_2. Management system review Records_1.管理评审程序_2.管理评审记录 _1. Customer notification procedure for issues related to productquality_2. Customer notification records for product quality issues_1.产品质量相关问题的客户通知程序_2.与产品质量问题相关的客户通知记录 _1. Customer Complaint Records_2. Root C

14、ause Analysis & Investigation Reports_1.客户投诉记录_2.根本原因分析和调查报告Written Procedure for control of documents:_1 . Formulas,_2. Specifications,_3. BOM,_4. Procedures_5. Work instructions,文件控制程序：_1.配方_2.规格，_3.物料清单，_4.程序_5.作业指导书_1. Master List of Controlled documents._1.受控文件总清单._1. Procedure for preventi

15、on of raw materials, packaging andfinished product contamination._2. Working Instruction for prevention of raw materials, packagingand finished product contamination._1.原料，包装和成品污染的预防程序._2.原料，包装和成品污染的预防工作指令_1. Procedure for retaining reference samples_2. Record of Sample Retention & Control_3. Re

16、cord of Sample Disposal_ 1.保留参考样品的程序_2.样品保留及控制的记录_3.样品处理的记录_1. Testing/Analysis procedure_2. Customer testing/analysis requirements_3. List of test item (in-house and/or subcontract)._4. Raw Material + Finished Products Test reports_1.测试/分析程序_2.客户测试/分析的需求_3.测试项目列表（内部和/或分包）._4.原材料+成品测试报告_1. Lab Certi

17、fication_2. List of Certified Lab Technician or Engineer_3. List of Accredited Testing Capability_1. 工厂内部实验室被认可证书_2.被认可的实验室技术员或工程师名单_3.认可的测试能力清单DocumentDocument 文文件件名名称称_1. Temperature control register_2. Humidity control register_1.温度控制记录_2.湿度控制记录 _1. Supplier approval & Performance monitoring

18、procedure_2. Clients approved supplier list for raw materials, packagingand utilities._1.供应商的批准和绩效监控程序_2.客户批准的原材料，包装和设备供应商列表 _1. Procedure for supplier approval and on-going performancemonitoring_2. On-going monitoring Reports_1.对供应商的批准和绩效监控程序_2.绩效监控报告_1. Procedure showing lot identification methods

19、 andtraceability system covering Incoming raw materials/components,_1.来料/部件的标识和可追溯系统程序_1. Raw material/ components traceability records/reports _1.原材料/部件的追溯记录/报告_1. #1 Raw material/ components Records Traceable to thisclient._1.# 1原材料/零部件可追溯到客户的记录._1. Written operating procedures,_2. Work Instructio

20、ns and_3. Reference Documents_1.书面操作程序_2.作业指导书_3.参考文献_1. Controlled Documents in use at the workplace现场作业的受控文件记录2. Raw Material Warehouse原原材材料料仓仓库库_1. Pest control Service Records_2. List of pest control check point points (Rodents points etc.)_1.虫害控制记录_2.虫害控制检查点列表（啮齿动物等）_1. Procedure for the preven

21、tion of raw materials, packaging andfinished product contamination._2. Working Instruction for prevention of raw materials, packagingand finished product contamination._1.原材料，包装和成品污染的预防程序._2.原料，包装和成品污染的预防工作指令._1. Raw materials checking, usage and storage records_1.原材料检验，使用和存储记录_1. Bill of Materials

22、of materials for running order_2. Material First In - First Out stock records of the running order_3. Material Shelf Life Record of running order_1.在线生产订单的材料清单_2.在线生产订单材料先进先出库存记录_3.在线生产订单材料保质期记录_1. Raw Materials Inspection report_2. Finished Products Inspection reports_1.原材料检验报告_2.成品检验报告_1. Procedur

23、es for the identification, segregation, investigationand disposition of non-conforming raw materials (includingpackaging), work-in-progress and finished products._2. Disposition Report of non-conforming raw materials/ products._1.不合格的原材料（包括包装），半成品及成品的标识，隔离，调查和处理程序_ _2.不合格的原材料/产品处理报告._1. Record of NC

24、 products_1.不合格品记录_1. Inspection plan for incoming materials and component _1.来料和部件的检验计划DocumentDocument 文文件件名名称称_1. Temperature control register_2. Humidity control register_1.温度控制记录_2.湿度控制记录_1. Written procedure for the control of production items._2. List of controlled items used in production.1.

25、控制生产项目的书面程序.2.生产中使用的受控项列表_1. Control records (eg. sharp tools in-out records or brokenneedle control log) of a production item.1.外来物控制记录（如锋利工具的进出记录或断针控制日志）3. Production- Line生生产产线线_1. Procedure for corrective actions and reporting of lost/brokenproduction items_2. Record of lost/broken production it

26、em incident_1.报告丢失/损坏生产使用项目如利器和纠正措施程序_2.丢失/损坏生产使用项目记录_1. Procedure for corrective actions and reporting of metal orforeign body detector failure_2. Record of a metal or foreign body detector failure incident_3. Detector calibration and maintenance records of the selectedincident_1.报告金属探测仪器失效事故和纠正措施程

27、序_2.金属探测仪器失效事故的记录_3.金属探测仪器的校准维护记录（针对已发事故）_1. Procedure showing lot identification methods andtraceability system covering Semi-finished products and Final orfinished products_1.半成品和成品的的标识和可追溯系统程序_1. Written operating procedures,_2. Work Instructions and_3. Other Reference Documents_1.书面的操作程序，_2.指导工作

28、_3.其他参考文献_1. Controlled Documents in use at the workplace现场作业的受控文件记录_1. Raw materials, packaging and finished products checking,usage and storage records_1.原材料，包装和成品检验，使用和存储的记录_1. Procedures for the identification, segregation, investigationand disposition of non-conforming raw materials (includingp

29、ackaging), work-in-progress and finished products._2. Disposition Report of non-conforming raw materials/ products._1.不合格的原材料（包括包装），半成品及成品的标识，隔离，调查和处理程序_ _2.不合格的原材料/产品处理报告._1. Non-conformance material Corrective Action & PreventiveAction Report_2. Implementation Report/Plan_1.不合格材料的纠正预防措施报告_2.执行

30、报告/计划_1. Record of NC products_1.不合格品记录_1. Work-in-process Inspection procedure_2. WIP inspection records / reports_1.半成品检验程序_2.半成品检验 记录/报告_1. Inspection procedure_2. Inspection Schedule & sampling plan._3. Inspection report formats. (incoming/WIP/Pre-final, Finalinspection reports)_1.检查程序_2.检查频

31、次和抽样计划._3.检验报告的格式.（来料/半成品/近成品，成品检验报告）_1. Clients updated quality manuals_2. Company quality manuals on defect classification,specifications_3. Inspection records (Inline, end line, pre-final & finalinspection)_1.客户更新的质量手册_2.缺陷分类和质量规格书_3.检查记录（在线，下线，近成品，成品检验）_1. Procedures showing re-evaluation of

32、 released productsmeasured by the defected equipment since last acceptedcalibration date, quarantine of affected products_2. CAPA report showing action taken on affected products dueinaccurate measurements._3. Records of Product Recall or specific handling records fordefect equipment issue._1.对被缺陷仪器

33、放行的产品的再评估记录_2.纠正预防措施报告_3.缺陷设备事件中的产品召回记录或特定处理记录_1. Companys policy for employee jewelry control_1.员工佩戴饰品的管理政策DocumentDocument 文文件件名名称称_1. Written procedure for the control of production items._2. List of controlled items used in production.1.控制生产项目的书面程序.2.生产中使用的受控项列表_1. Control records (eg. sharp too

34、ls in-out records or brokenneedle control log) of a production item.1.生产项目控制记录（如锋利工具的进出记录或断针控制日志）_1. Procedure for calibration, maintenance and application ofdetectors_2. List of detectors used in production._3. Calibration and maintenance records of detector_1.探测器的校准，维护和使用程序_2.生产中使用的探测器列表._3.探测器的校准

35、和维护记录4.4. QCQC & & ComplianceCompliance DeptDept质质量量控控制制& &合合规规性性部部门门_1. Metal/foreign-body detector inspection record + Customerorder record_1.金属/异物探测器检查记录+客户订单记录_1. Procedure for corrective actions and reporting of metal orforeign body detector failure_2. Record of a metal or forei

36、gn body detector failure incident_3. Detector calibration and maintenance records of the selectedincident_1.报告金属探测仪器失效事故和纠正措施程序_2.金属探测仪器失效事故的记录_3.金属探测仪器的校准维护记录（针对已发事故） _1. Internal audit procedure on the factory management_2. Objective Evidence records_3. Detailed internal audit & implementation

37、 plan_4. Objective Evidence records_1.内审程序_2.客观证据的记录_3.详细的内部审核和实施计划_4.客观证据的记录_1. Audit Non-Conformity Report_2. CAPA Report_1.不符合项报告_2.纠正预防措施报告 _1. Supplier approval & Performance monitoring procedure_2. Clients approved supplier list for raw materials, packagingand utilities._1.供应商的批准和绩效监控程序_2.

38、客户批准的原材料，包装和设备供应商列表 _1. Procedure for supplier approval and on-going performancemonitoring_2. On-going monitoring Reports_1.对供应商的批准和绩效监控程序_2.绩效监控报告 _1. Procedure for testing of traceability system_2. Reports for traceability testing_3. Corrective Action records_1.对于可追溯系统的测试程序_2.可追溯性测试报告_3.纠正措施记录 _1.

39、 Procedure of a system for investigating the cause ofsignificant non-conformity against Manufacturing relatedoperation procedures which are critical to product safety, legalityand quality._1.与产品安全，合法性和质量相关的重大违反制造操作规程的原因调查程序._1. QC Reports_2. Production Reports_ 3. Others, pls specify : _1.质检报告_2.生产报

40、表_ 3.其他，请注明：_1. Procedure for prevention of glass contamination _1.玻璃污染的预防程序_1. Corrective Action & Preventive Action Report for non-conformance identified._2. Corresponding Implementation Report/Plan_1.已查明不合规事件的纠正和预防措施报告._2.相应的实施报告/计划_1. Procedure for retaining reference samples_2. Record of Sa

41、mple Retention & Control_3. Record of Sample Disposal_1.保留参考样品程序_2.样品保留及控制的记录_3.样品处理的记录_1. Work-in-process Inspection procedure_2. WIP inspection records / reports_1.半成品检验程序_2.半成品检验记录/报告_1. Inspection procedure_2. Inspection Schedule & sampling plan._3. Inspection report formats. (incoming/W

42、IP/Pre-final, Finalinspection reports)_1.检查程序_2.检查频次和抽样计划._3.检验报告的格式.（来料/半成品/近成品，成品检验报告）_1. Clients quality manuals_2. Company quality manuals on defect classification,specifications_3. Inspection records (Inline, end line, pre-final & finalinspection)_1.客户质量手册_2.缺陷分类和质量规格书_3.检查记录（在线，下线，近成品，成品检验

43、）_1. Pre-final and final inspection procedure_2. Pre-final inspection records_3. Final Inspection records_1.近成品及成品检验程序_2.近成品检验记录_3.成品检验记录_1. Packaging configuration and labeling requirements (for thisclient)_2. Client Approved packing sample, labelling_3. Inspection reports_1.包装配置和标签要求（此客户）_2.客户认可的包

44、装样品，标签_3.检验报告_1. Quality controller/Inspector training procedure & qualificationprogram_2. List of qualified QC/Inspectors_3. Training records._1.质量控制/检查员培训程序和认可具备资质程序_2.合格的质量控制/检查人员名单_3.培训记录._1. Procedures for health and hygiene program._1.健康和卫生管理政策.DocumentDocument 文文件件名名称称_1. Temperature cont

45、rol register_2. Humidity control register_1.温度控制记录_2.湿度控制记录_1. Metal/foreign-body detector inspection record + Customerorder record_1.金属/异物探测器检查记录+客户订单记录_1. Procedure showing lot identification methods andtraceability system covering Final or finished products_1.成品的的标识和可追溯系统程序_1. Written operating p

46、rocedures,_2. Work Instructions and_3. Other Reference Documents_1.书面的操作程序，_2.工作指导_3.其他参考文献_1. Controlled Documents in use at the workplace工作场所中的受控文档_1. Finished Products Inspection reports (inline, endline and prefinal inspection reports )_1.成品检验报告（在线，下线和最终前检验报告）5.5. PackagingPackaging / / Finishin

47、gFinishing包包装装/ /加加工工_1. Finished products Final inspection reports_1.成品最终检验报告_1. Record of NC products_1.不合格品记录_1. Pre-final inspection records_2. Final Inspection records_1.近成品检验记录_2.成品检验记录_1. Packaging configuration and labeling requirements (forrunning order)_2. Client Approved packing sample, l

48、abelling_3. Inspection reports_1.包装配置和标签要求（在线生产订单）_2.客户认可的包装样品，标签_3.检验报告DocumentDocument 文文件件名名称称_1. Temperature control register_2. Humidity control register_1.温度控制记录_2.湿度控制记录_1. Finished products checking, usage and storage records_1.成品检验，使用和存储的记录DocumentDocument 文文件件名名称称_1. Final Product Outgoing

49、 Records_1.最终产品出货记录_1. #1 Raw material/ components Records Traceable to thisclient_1.# 1追溯到客户的原材料/零部件记录DocumentDocument 文文件件名名称称_1. Testing/Analysis procedure_2. Customer testing/analysis requirements_3. List of test item that can be done in-house or subcontract._4. Raw Material + Finished Products

50、Test reports_ 1.测试/分析程序_2.客户测试/分析的要求_3.内部或分包的测试项目列表_4.原材料+成品试验报告_1. Equipment calibration / recalibration record + NationalStandards Documentation_1.设备的校准/重校准记录+国家标准文件_1. Equipment calibration / recalibration record_1.设备的校准/重校准记录6.6. FinishedFinished ProductProduct WarehouseWarehouse成成品品仓仓库库7.7. Shi

51、ppingShipping运运输输8.8. LaboratoryLaboratory实实验验室室_1. List of equipment found to have outside tolerances_2. Records for re-calibration / maintenance / adjustment +Record of replacement / scrap / return_1.有外径公差的设备清单_2.重校准/维护/调整的记录+替换/废弃/重新使用的记录_1. List of Qualified or Certified Staff/Engineers to perfo

52、rm testing_2. Training record / certificate of the qualified staff/Engineers toperform testing_1.合格或被认可的测试人员/工程师名单_2.执行测试的合格人员/工程师的培训记录/证书DocumentDocument 文文件件名名称称_1. Factory Cleaning Procedure_2. Cleaning schedules and records_1.工厂的清洁程序_2.清洁计划和记录_1. Equipment calibration / recalibration record with

53、 Calibrationdates and standards test against + National StandardsDocumentation_1.根据国家标准文档进行的带有校准日期的设备校准/重校准记录_1. Equipment calibration / recalibration record_1.设备的校准/重校准记录_1. List of equipment found to have outside tolerances_2. Records for re-calibration / maintenance / adjustment +Record of replac

54、ement / scrap / return_1.有外径公差的设备清单_2.重校准/维护/调整的记录+替换/废弃/返回记录_1. Procedures for the re-evaluation of released productsmeasured by the defected equipment_2. Corresponding CAPA report_3. Records of Product Recall_1.对被缺陷仪器放行的产品的再评估记录_2.相应的纠正预防报告_3.产品召回记录DocumentDocument 文文件件名名称称_1. Pest control procedu

55、re_2. Pest Control Contract with sub-contracted company_3. Pest control Service Records_4. Training record for the internal pest control personnel_1.虫害控制程序_2.与转包公司的虫害控制合同_3.虫害控制服务记录_4.对于内部虫害控制人员的培训记录9.9. MachineMachine MaintenanceMaintenance机机器器维维护护10.10. PestPest ControlControl虫虫害害控控制制_1. Pest cont

56、rol Service Records_2. List of pest control check point points_1.虫害控制服务记录_2.虫害控制检查点列表_1. List of pest activity in the factory premises._ 2. Pest Activity Report_1.厂房虫害活动列表_ 2.虫害活动报告DocumentDocument 文文件件名名称称_1. Procedure of waste disposal program_2. List of waste type/materials_3. Record of waste dis

57、posal_4. Approved Suppliers List for collecting & disposing wastematerials._1.废物处理程序_2.废物类型/材料清单_3.废物处理记录_4.收集和处理废物的供应商名单._1. 1. Cleaning & Maintenance schedule of the wastecontainers.(including periodic schedule)_2. List & locations of waste containers in the factory_3. Method of cleani

58、ng the waste containers to verify theappropriate cleaning practices were adopted._1.废物容器的清洁和维护时间表.（包括定期时间表）_2.工厂废物容器的列表和位置_3.清理废物容器的方法，确保使用了适当的清洗操作法.DocumentDocument 文文件件名名称称_1. Procedure for chemical control化学品控制程序_1. Manual or master list of all chemicals used in the factory_2. Material Safety Dat

59、a Sheet_1.工厂使用的所有化学品手册和列表_2. 材料安全数据表_1. List of authorized personnel to handle all chemicals types_2. Training record of authorized personnel_3. Training Materials or Agenda that authorized personnel_1.获授权处理所有化学品类型的人员名单_2. 授权人员的培训记录_3. 授权人员的培训材料或日程表11.11. WasteWaste DisposalDisposal废废物物处处理理12.12. Ch

60、emicalChemical ControlControl化化学学品品控控制制13.13. HRHR人人力力资资源源DocumentDocument 文文件件名名称称_1. Employee training records 员工培训记录_1. Procedures for health and hygiene program. _1.健康和卫生程序._1. Companys policy for employee jewelry control_1.员工佩戴饰品的管理政策DocumentDocument 文文件件名名称称_1. Quality controller/Inspector training procedure & qualificationprogram_2. List of qualified QC/Inspectors_3. Corresponding