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(yàn)廠審核過(guò)程中,審核員將會(huì)要求工廠提供以下相關(guān)文件:
1. Business License 營(yíng)業(yè)執(zhí)照
2. Organization Chart – Please supply prior to audit with Factory Profile. 組織結(jié)構(gòu)圖
3. ISO9000 / 14000, SA8000, HACCP, BRC等認(rèn)證證書(shū)(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(shè)備清單
6. Machines Maintenance Plan & Records設(shè)備保養(yǎng)計(jì)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(biāo)
9. Quality Manual– Please supply prior to audit with Factory Profile. 質(zhì)量手冊(cè)
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(xiǎn)和風(fēng)險(xiǎn)管理系統(tǒng)(包括危害和風(fēng)險(xiǎn)管理體系小組、產(chǎn)品信息關(guān)鍵參數(shù)、預(yù)期用途、工藝流程、關(guān)鍵控制點(diǎn)的選擇、關(guān)鍵限值、檢測(cè)系統(tǒng)和糾正措施計(jì)劃、驗(yàn)證程序、記錄、危害和風(fēng)險(xiǎn)管理體系的評(píng)審)
11. Management Review Procedure and Record 管理評(píng)審程序/記錄
12. Internal Audit Plan & Records 內(nèi)審計(jì)劃/記錄
13. Training records including work skill, GMP & personal hygiene 員工的培訓(xùn)記錄(包括工作技能、GMP及個(gè)人衛(wèi)生等)
14. Legal Statutes and Mandatory Standards Applicable to Products/ Materials 產(chǎn)品,物料相關(guān)的擬銷售地區(qū)的法律法規(guī)和強(qiáng)制性標(biāo)準(zhǔn)
15. Personal hygiene standards 個(gè)人衛(wèi)生標(biāo)準(zhǔn)
16. Contract Review Record 合同評(píng)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(yīng)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(jì)量/ 測(cè)試儀器臺(tái)帳
22. Measuring Equipment Calibration Certificate and Records 計(jì)量?jī)x器校驗(yàn)證書(shū)/記錄
23. Master Reference Standards Calibration Certificate 標(biāo)準(zhǔn)塊的校驗(yàn)證書(shū)(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(gòu)程序,采購(gòu)合同
26. Quality control Instructions (Incoming Materials/ Sub-contracting Product Inspection, In-process Inspection & Finished product inspection Instructions) 檢驗(yàn)規(guī)范(進(jìn)料檢驗(yàn)、過(guò)程檢驗(yàn)、外發(fā)工序/產(chǎn)品以及成品檢驗(yàn))
27. Production Plan 生產(chǎn)計(jì)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(jiān)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(cè)有效運(yùn)作、日常監(jiān)測(cè)、檢測(cè)及校準(zhǔn)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(yù)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(shè)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(xué)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(shè)備清潔包括過(guò)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(xiǎn)廢棄物的文件和記錄)
45. Pest Control Procedure And Relevant Record 防蟲(chóng)害控制程序和相關(guān)的控制記錄
46. Product Start-Up And Change-Over Procedure 產(chǎn)品開(kāi)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(guān)檢驗(yàn)程序和報(bào)告;生產(chǎn)進(jìn)度報(bào)表;成品測(cè)試報(bào)告包括微生物、化學(xué)檢測(cè)、水質(zhì)測(cè)試、安全測(cè)試、壽命可靠性測(cè)試、功能測(cè)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(guān)記錄,年度演練記錄
上海勵(lì)奧質(zhì)量技術(shù)服務(wù)有限公司
地址:上海市青浦區(qū)滬青平公路2799弄8號(hào)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(jī):13524968276
江蘇地區(qū):
聯(lián)系人:劉經(jīng)理
手機(jī):13524551252
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