3.1 Quality Policy 質量方針
3.1.1 Does the management demonstrate commitment to following an appropriate quality process? 管(guan)理層是否能證明他們嚴格執行了相應的質量(liang)管(guan)理體系(xi)？ 3.1.2 Does the factory have ISO 9000 accreditation? 工廠是否經過ISO9000的認可？ 3.1.3 Does the factory have an appropriate documented quality policy which has been communicated, understood and is used by the factory? 工廠是否制定了恰(qia)當的質量方針手(shou)冊，該手(shou)冊經過與員工的溝通并且得到員工的理解和使用？ 3.2 Implementation of Quality System 質量管理體系的實行
3.2.1 Is the quality management system documented, used and monitored? 該質量管理體系是(shi)否有(you)書(shu)面記錄、執行并得到有(you)效監督(du)？ 3.2.2 Is there an effective quality manual in place and used? 是否制定并使用了質量管理手冊？
3.2.3 Does the factory have appropriate quality procedures in place and used? 工廠是否制定(ding)并使用了恰當的質量管(guan)理程序？ 3.2.4 Are there suitable document control processes in operation? 在(zai)操作中是(shi)否有(you)恰當的文件控制程(cheng)序(xu)？ 3.3 Competency, Training and Responsibility 能力、培訓和責任
3.3.1 Are responsibilities in the factory defined and known by the necessary people? 是(shi)否在(zai)工廠(chang)內部進行了(le)清楚的職責劃分并將其告知有關人員？ 3.3.2 Is there an effective, empowered manager with QA authority? 工廠內是否(fou)有(you)一個有(you)效的(de)、有(you)力(li)的(de)質(zhi)保負責人？ 3.3.3 Are the workforce suitably educated, trained, capable and experienced for the jobs they are required to do? 工人是否(fou)經過合適的教育、培(pei)訓，并能勝任(ren)他們(men)所要做的工作？ 3.3.4 Do the workforce understand their part of the manufacturing process, are they trained, is training recorded and updated? 工人們(men)(men)是(shi)否理解他(ta)們(men)(men)所操(cao)作部(bu)分的制造工藝(yi)，他(ta)們(men)(men)受過相關(guan)培訓(xun)嗎(ma)？培訓(xun)是(shi)否得(de)到記(ji)錄并時常(chang)更新？ 3.4 Measurement and Improvement 衡量和改進
3.4.1 Are the procedures used assessed and reviewed, so that they are consistent with the quality policy of the factory? 工(gong)廠(chang)目前使用的(de)(de)程序(xu)是否經過評估和(he)審(shen)查，這(zhe)樣(yang)它可以和(he)工(gong)廠(chang)的(de)(de)質量(liang)管理(li)方(fang)針(zhen)保(bao)持(chi)一(yi)致(zhi)性？ 3.4.2 Are effective internal audits and necessary corrective actions implemented in appropriate timescales? 是否進行(xing)定期的(de)企業內審并采取了(le)相(xiang)應(ying)的(de)整改措施？ 3.4.3 Is an appropriate calibration process in place which is traceable and documented? 是否(fou)制定了一個恰(qia)當的校準程序(xu)，該程序(xu)可被查詢(xun)并(bing)可被書面(mian)記(ji)錄(lu)？ 3.4.4 Does the factory have a customer feedback/complaint process which identifies problems and non-conformances? If so, are suitable corrective and preventative actions taken? 工廠是否制定了客戶意見反饋/投訴程序來識別問題和違規？如果有的話，有沒有制定合適的改正、預防方案？
3.5 Customer Focus 客戶
3.5.1 Do processes exist which ensure customer needs, specifications and requirements are understood and met? 是否制定了相應的程序來確保客戶的需求和要求被正確的理解并能得到滿足？
3.5.2 Is customer feedback monitored, reviewed and action taken? 客(ke)戶的反饋是否得到關注(zhu)、時常回顧(gu)并采取相應(ying)措(cuo)施(shi)？ 3.6 Design & Development 設計和發展
3.6.1 Are product requirements and technical details reviewed to ensure they meet customers safety, suitability, standards and specification requirements, before and during production? 是否在生(sheng)產前及生(sheng)產的過(guo)程中，對產品的要求及工藝過(guo)程進行審核，以確保達到客戶在產品安(an)全性、恰當性以及產品標準(zhun)和規格方面(mian)的要求？ 3.6.2 Do appropriate 'Technical Files' exist? 是(shi)否制定了相應的技(ji)術文件？ 3.6.3 Is pack wording reviewed for suitability before production? 生產前是(shi)否(fou)對包裝(zhuang)上的文字正確(que)性進行(xing)了檢查？ 3.6.4 Are instructions reviewed for suitability before production? 生產前是否對說明書的正確性(xing)進行了檢查？ 3.6.5 Is there appropriate safety certification available for products being manufactured? 產(chan)品制造前是否獲得(de)相關的安全證書？ 3.6.6 Is there an effective design validation process in place for products being manufactured? 正在生產(chan)的(de)產(chan)品(pin)是否有一(yi)個見效的(de)設計(ji)確認程序(xu)？ 3.6.7 Are processes suitable to prevent design changes without appropriate checks and authorisation? 程序中是否可以有效阻止未經檢查和授權的設計變更？
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