Argos品質(zhì)驗(yàn)廠審核過程中的驗(yàn)廠審核清單-僅供參考
1. Quality Manual (including quality
policy, bives, organization chart, job debion, reference to /
procedures for the Quality Management System)
品質(zhì)手冊(cè)（包括質(zhì)量方針，質(zhì)量目標(biāo)，組織架構(gòu)圖，工作職責(zé)描述，及與品質(zhì)管理體系相關(guān)的程序）
2. Management Review (procedure,
agenda, report)
管理評(píng)審（程序，議題，報(bào)告）
3. Internal audit documents
(procedure, plan, audit report)
內(nèi)審文件（程序文件，計(jì)劃，評(píng)審報(bào)告）
4. Supplier Control documents (supplier
approval control procedure / criteria, list of approval supplier list, supplier
buation records)
供應(yīng)商管控文件（供應(yīng)商評(píng)估控制程序/標(biāo)準(zhǔn)，合格供應(yīng)商明細(xì)，供應(yīng)商評(píng)估報(bào)告）
5. Document Control procedure
(including that for record keeping)
文件控制程序（包括記錄文件）
6. Inspection Specification /
Instruction (including IQC, In-process, Final)
檢驗(yàn)標(biāo)準(zhǔn)/指導(dǎo)（包括來料檢驗(yàn)，制成檢驗(yàn)及終檢）
7. Work Instruction for each
manufacturing process
作業(yè)指導(dǎo)：所有生產(chǎn)工序的指導(dǎo)
8. Procedure for definition and
reporting of “incident”
事故定義及報(bào)告程序
9. Product recall procedure
產(chǎn)品招回程序
10. Customer complaints procedure and
complaint records
客戶投訴程序及記錄
11. Corrective Action reports (related
to incident, internal audit, complaint, etc)
改善措施報(bào)告（與事故，內(nèi)審及投訴等相關(guān)的）
12. Test records on Traceability
system
追溯體系的測(cè)試記錄
13. Equipment maintenance documents
(plan, procedure, record)
設(shè)備保養(yǎng)文件（保養(yǎng)計(jì)劃，保養(yǎng)程序及保養(yǎng)記錄）
14. Calibration of monitoring &
measuring devices (plan, procedures, records)
監(jiān)控及測(cè)量儀器的校驗(yàn)（計(jì)劃，程序文件，記錄）
15. Written procedure for handling
glass and hard b plastic breakages Cleaning
schedule and procedure
書面玻璃及利器管控程序和清理安排
16. Waste handling / storage procedure
or record
廢品控制/存儲(chǔ)程序及記錄
17. Pest control documents (list of
trained pest control staff, contract with external pest control agency, pest
control inspection record, bait documentation)
蟲害控制文件（專業(yè)蟲害控制人員名單，與外部蟲害控制公司的合同書，蟲害控制記錄等）
18. Process flow documentation
工藝流程文件
19. Record / plan for “Hazard
Analysis” of the entire production processes
全部流程的風(fēng)險(xiǎn)評(píng)估計(jì)劃及記錄
20. Hazards Assessment records during
product design and development
產(chǎn)品設(shè)計(jì)及開發(fā)過程中的風(fēng)險(xiǎn)評(píng)估記錄
21. Monitoring records of foreign body
detectors (e.g. daily sensitivity records of bl detectors)
外來物品探測(cè)器（比如：每日金屬探測(cè)記錄）
22. Broken needle procedure &
records (if applicable)
斷針控制程序及記錄（如果適用）
23. Sharp tool control procedure &
records (if applicable)
利器控制程序及記錄（如果適用）
24. Nonconbing product control
procedure
不良品控制程序
25. Guidance on quantity checking
產(chǎn)品數(shù)量檢查指導(dǎo)
26. Approved reference samples
合格樣品
27. Control procedure for equipment
failure and process deviation
不良儀器的管控程序及隔離控制
28. Factory’s own training program
(plan, procedure, records)
工廠內(nèi)部的培訓(xùn)計(jì)劃（計(jì)劃，程序，記錄）
