During the Audit, auditors may request any of the following documents or others to support the Audit. These should be made available within 4 Hours of the request as specified in the Morrison’s terms of business.
Morrisons驗廠審核過程中,審核員將會要求工廠提供以下相關文件:
1. Business License 營業(yè)執(zhí)照
2. Organization Chart – Please supply prior to audit with Factory Profile. 組織結構圖
3. ISO9000 / 14000, SA8000, HACCP, BRC等認證證書(如有)
4. Process Flow Diagram – Please supply prior to audit with Factory Profile. 工序流程圖
5. Machinery List– Please supply prior to audit with Factory Profile. 設備清單
6. Machines Maintenance Plan & Records設備保養(yǎng)計劃/記錄
7. Quality Policy – Please supply prior to audit with Factory Profile. 質(zhì)量方針
8. Quality Objective 質(zhì)量目標
9. Quality Manual– Please supply prior to audit with Factory Profile. 質(zhì)量手冊
10. HARMS (Hazard and Risk Management System), Principles including HARMS team, production information, intended use, process flow, CCP, monitoring System, CAPs, verification procedure, documentation and record keeping, HARMS review etc.– Please supply prior to audit with Factory Profile.
危險和風險管理系統(tǒng)(包括危害和風險管理體系小組、產(chǎn)品信息關鍵參數(shù)、預期用途、工藝流程、關鍵控制點的選擇、關鍵限值、檢測系統(tǒng)和糾正措施計劃、驗證程序、記錄、危害和風險管理體系的評審)
11. Management Review Procedure and Record 管理評審程序/記錄
12. Internal Audit Plan & Records 內(nèi)審計劃/記錄
13. Training records including work skill, GMP & personal hygiene 員工的培訓記錄(包括工作技能、GMP及個人衛(wèi)生等)
14. Legal Statutes and Mandatory Standards Applicable to Products/ Materials 產(chǎn)品,物料相關的擬銷售地區(qū)的法律法規(guī)和強制性標準
15. Personal hygiene standards 個人衛(wèi)生標準
16. Contract Review Record 合同評審記錄
17. Specifications for Incoming Materials and Final Products 原材料和產(chǎn)品的規(guī)范要求
18. Products Change Records 產(chǎn)品變更記錄
19. Suppliers / Sub-contractor Control Procedure and Assessment Record 供應商/分包商控制程序和審核記錄
20. Customer Complain Procedure 顧客抱怨處理程序
21. Measuring / Testing Equipment List 計量/ 測試儀器臺帳
22. Measuring Equipment Calibration Certificate and Records 計量儀器校驗證書/記錄
23. Master Reference Standards Calibration Certificate 標準塊的校驗證書(如適用)
24. Internal Calibration Procedure and Record,Internal Calibration Staff Qualified Certification 內(nèi)校員資質(zhì),內(nèi)校程序和記錄
25. Purchase Procedure, Purchase Order 采購程序,采購合同
26. Quality control Instructions (Incoming Materials/ Sub-contracting Product Inspection, In-process Inspection & Finished product inspection Instructions) 檢驗規(guī)范(進料檢驗、過程檢驗、外發(fā)工序/產(chǎn)品以及成品檢驗)
27. Production Plan 生產(chǎn)計劃
28. Defects Charted and Analyzed Records 質(zhì)量分析記錄
29. Packaging Instructions 包裝指示
30. Sharp Tools Control Procedure, Sharp Tools Losing Investigation Procedure (If applicable) 利器控制程序及利器丟失調(diào)查程序(如適用)
31. Daily Issuance & Return of Sharp Tools Records (If applicable) 利器日常收發(fā)/檢查記錄(如適用)
32. Broken Needle Policy/ Record (If applicable) 斷針控制程序/記錄(如適用)
33. Glass, brittle and hard plastic control procedure and relevant register list and control record 玻璃、易碎品和堅硬的塑料及類似品的控制程序、登記清單和檢查記錄
34. Procedure for the effective operation, routine monitoring, testing and calibration of metal detector and relevant control record
金屬探測有效運作、日常監(jiān)測、檢測及校準的程序和記錄
35. Non-conforming Material Control Procedure 不合格品控制程序
36. Corrective & Preventive Actions Procedure/ Records 糾正預防措施程序/記錄
37. Documents Control Procedure 文件控制程序
38. Documented Facility Inspection Procedure 定期設施檢查程序
39. Regular Hygiene And Fabrication Record 定期(至少每月)衛(wèi)生和裝備建筑檢查記錄
40. Regular Air Microbiological Monitoring Record 定期空氣微生物監(jiān)控記錄
41. Chemicals Control Procedure 化學品控制程序
42. Wood Control Procedure And Condition Checking Record If Applicable 木制品控制程序和衛(wèi)生條件檢查記錄
43. Equipment Cleaning Procedure Including Process Cleaning And CIP Cleaning 設備清潔包括過程清潔和原地清潔體系
44. Waste Handling Control Procedure 廢物處理控制程序(有資質(zhì)的承包商處理危險廢棄物的文件和記錄)
45. Pest Control Procedure And Relevant Record 防蟲害控制程序和相關的控制記錄
46. Product Start-Up And Change-Over Procedure 產(chǎn)品開線和換線控制程序
47. Packaging And Coding Control Procedure 產(chǎn)品包裝材料和編碼控制程序
48. Inspection And Test Procedure & Report For Raw Material, Packaging Material, WIPs And Finished Product Including Microbiological, Chemical Test, Water Test, Safety Test, Life/Reliability Test, Function Test
原材料、半成品和成品的相關檢驗程序和報告;生產(chǎn)進度報表;成品測試報告包括微生物、化學檢測、水質(zhì)測試、安全測試、壽命可靠性測試、功能測試等
49. Incidents, Product Withdrawals And Recall Control Procedure And Relevant Record; Annual Mock Recall Record 事故、產(chǎn)品撤回和召回控制程序和相關記錄,年度演練記錄
上海勵奧質(zhì)量技術服務有限公司
地址:上海市青浦區(qū)滬青平公路2799弄8號1樓
電話:021-36529816
Email: lm@leocorp.cn
浙江地區(qū):
聯(lián)系人:張經(jīng)理
手機:13524968276
江蘇地區(qū):
聯(lián)系人:劉經(jīng)理
手機:13524551252
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