工厂概括部分(Factory Profile)

1、工厂简介 Brief introduction of factory

2、营业执照 Business license

3、公司组织架构图 Organization chart

4、(公司)厂区/厂房平面图 Factory’s plane figure-factory floor plans

5、生产工序流程图 Production process chart

质量管理体系(Quality management system)

6、ISO9000证书及最近一次外审报告ISO 9000 certificate and the last external audit reports

7、质量手册 Quality manual

8、程序文件 Procedure

9、质量计划 Quality program

10、文件更改收发记录 Documents control records

管理职责(Management responsibility)

11、质量方针政策 Quality Polity

12、管理评审记录 Management review records

13、客户满意度评估流程 Customer satisfaction evaluation procedure

14、客户投诉处理记录 Complaint handling procedure and records

资源管理(Resource management)

15、员工培训计划 Worker training plan

16、员工质量培训记录 Worker quality training records

产品实现(Planning of product realization)

17、先期产品质量策划运行相关文件 APQP implemented documents

18、针对劳氏产品的过程潜在失效模式及后果分析 PFMEA for Lowe’s products

19、控制计划 Control Plan

20、标准样板流程程序(Documented process of master sample)

21、作业指导书 Working instructions

客户相关流程(Customer-related processes)

22、订单评审和客户关注程序及记录 Order review and customer focus procedure and records

设计和开发(Design and development)

23、开发设计控制程序Design control procedure

24、设计计划或任务书及审核记录 Design planning and input review record

25、验证和确认记录 verification and validation records

26、设计产品检测报告 design testing and record

27、设计输出（技术文件，物料单， 包装、使用说明）Design output (technical file, BOM, Packing and using description)

28、设计变更记录 （ECN）

采购(Purchasing)

29、供应商评审程序及记录Monitoring procedure and records of suppliers

30、供应商清单/合格供应商清单Suppliers list and qualified supplier list

31、采购单、采购合同 Purchase orders and purchase contracts

32、来料中免检产品的质量保证书Quality guaranty for exempt from inspection of incoming material/Receiving and distribution

33、来料验货标准及规格书IQC standard and specifications

34、来料检查、测试报告 IQC reports

35、来料收发记录Incoming material/Receiving and distribution records

生产和服务的提供(Production and service provision)

36、设备维护计划流程 Equipment planed maintainence process

37、设备维护时间表及记录 Equipment maintainence schedule and records

38、仪器，设备，量具包装及保存程序 Procedure providing for packaging and preservation of Equipment, tooling, gaging

39、巡拉记录 In line inspection records

40、IPQC检验测试标准、记录 IPQC inspection standard and records

41、终检检验测试标准、记录 FQC/OQC inspection standard and reports/ Defect goods control records

42、发货记录 Release records

监视和测量设备的控制(Control monitoring and measuring equipment)

43、仪器设备校验程序 Testing/measuring equipment calibration procedure

44、仪器设备校验计划 Testing/measuring equipment calibration plan

45、仪器设备清单、内外校记录报告 Testing/measuring equipments calibration records

46、测量系统分析相关文件/记录 Document and record of MSA

47、条码扫描仪及条码检查程序及记录 Barcode scanners and barcode verification procedure and record

监控和测量(Monitoring and measurement)

48、内部审核计划、记录 Internal audit plan and records

49、过程变更或作业变更相关记录 Process change or changeover related records

50、关键产品/过程特性测量、控制、改进计划及相关记录 The plan and records for measurement, control, improvement of key Product/Process Characteristics (KPCs)

51、关键产品/过程特性统计控制图表 SPC charts of Key Product/Process Characteristics

52、安全/可靠性测试报告 Safety / Reliability Testing reports/records

不合格品的控制 (Control of nonconforing product)

53、第三方年度检测报告 Third party annual testing report

54、不良品处理记录 Rejected goods control records

55、不良品退货、让步接收记录 Control procedure and concession records for defect goods

持续改进(Improvement)

56、纠正与预防措施记录/报告 Records/Reports of corrective actions and preventative action

社会责任(Social Accountability)

57、招聘政策 Recruitment policies

58、人事记录/员工入厂登记/花名册 Employees’ personalfiles/ Employment registration/roster

59、急救人员资格证书(如适用) Trained first aidercertificate(if applicable)

60、食堂卫生许可证/食堂员工健康证 Sanitation Permit forKitchen/ Health Certificate of kitchen employee