工廠概括部分(Factory Profile)

1、工廠簡介 Brief introduction of factory

2、營業執照 Business license

3、公司組織架構圖 Organization chart

4、(公司)廠區/廠房平面圖 Factory’s plane figure-factory floor plans

5、生產工序流程圖 Production process chart

質量管理體系(Quality management system)

6、ISO9000證書及最近一次外審報告ISO 9000 certificate and the last external audit reports

7、質量手冊 Quality manual

8、程序文件 Procedure

9、質量計劃 Quality program

10、文件更改收發記錄 Documents control records

管理職責(Management responsibility)

11、質量方針政策 Quality Polity

12、管理評審記錄 Management review records

13、客戶滿意度評估流程 Customer satisfaction evaluation procedure

14、客戶投訴處理記錄 Complaint handling procedure and records

資源管理(Resource management)

15、員工培訓計劃 Worker training plan

16、員工質量培訓記錄 Worker quality training records

產品實現(Planning of product realization)

17、先期產品質量策劃運行相關文件 APQP implemented documents

18、針對勞氏產品的過程潛在失效模式及后果分析 PFMEA for Lowe’s products

19、控制計劃 Control Plan

20、標準樣板流程程序(Documented process of master sample)

21、作業指導書 Working instructions

客戶相關流程(Customer-related processes)

22、訂單評審和客戶關注程序及記錄 Order review and customer focus procedure and records

設計和開發(Design and development)

23、開發設計控制程序Design control procedure

24、設計計劃或任務書及審核記錄 Design planning and input review record

25、驗證和確認記錄 verification and validation records

26、設計產品檢測報告 design testing and record

27、設計輸出（技術文件，物料單， 包裝、使用說明）Design output (technical file, BOM, Packing and using description)

28、設計變更記錄 （ECN）

采購(Purchasing)

29、供應商評審程序及記錄Monitoring procedure and records of suppliers

30、供應商清單/合格供應商清單Suppliers list and qualified supplier list

31、采購單、采購合同 Purchase orders and purchase contracts

32、來料中免檢產品的質量保證書Quality guaranty for exempt from inspection of incoming material/Receiving and distribution

33、來料驗貨標準及規格書IQC standard and specifications

34、來料檢查、測試報告 IQC reports

35、來料收發記錄Incoming material/Receiving and distribution records

生產和服務的提供(Production and service provision)

36、設備維護計劃流程 Equipment planed maintainence process

37、設備維護時間表及記錄 Equipment maintainence schedule and records

38、儀器，設備，量具包裝及保存程序 Procedure providing for packaging and preservation of Equipment, tooling, gaging

39、巡拉記錄 In line inspection records

40、IPQC檢驗測試標準、記錄 IPQC inspection standard and records

41、終檢檢驗測試標準、記錄 FQC/OQC inspection standard and reports/ Defect goods control records

42、發貨記錄 Release records

監視和測量設備的控制(Control monitoring and measuring equipment)

43、儀器設備校驗程序 Testing/measuring equipment calibration procedure

44、儀器設備校驗計劃 Testing/measuring equipment calibration plan

45、儀器設備清單、內外校記錄報告 Testing/measuring equipments calibration records

46、測量系統分析相關文件/記錄 Document and record of MSA

47、條碼掃描儀及條碼檢查程序及記錄 Barcode scanners and barcode verification procedure and record

監控和測量(Monitoring and measurement)

48、內部審核計劃、記錄 Internal audit plan and records

49、過程變更或作業變更相關記錄 Process change or changeover related records

50、關鍵產品/過程特性測量、控制、改進計劃及相關記錄 The plan and records for measurement, control, improvement of key Product/Process Characteristics (KPCs)

51、關鍵產品/過程特性統計控制圖表 SPC charts of Key Product/Process Characteristics

52、安全/可靠性測試報告 Safety / Reliability Testing reports/records

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

53、第三方年度檢測報告 Third party annual testing report

54、不良品處理記錄 Rejected goods control records

55、不良品退貨、讓步接收記錄 Control procedure and concession records for defect goods

持續改進(Improvement)

56、糾正與預防措施記錄/報告 Records/Reports of corrective actions and preventative action

社會責任(Social Accountability)

57、招聘政策 Recruitment policies

58、人事記錄/員工入廠登記/花名冊 Employees’ personalfiles/ Employment registration/roster

59、急救人員資格證書(如適用) Trained first aidercertificate(if applicable)

60、食堂衛生許可證/食堂員工健康證 Sanitation Permit forKitchen/ Health Certificate of kitchen employee