3.1 Quality Policy 質量方針
3.1.1 Does the management demonstrate commitment to following an appropriate quality process? 管理(li)層是否(fou)能證明(ming)他們嚴格(ge)執行了相應的質(zhi)量管理(li)體系？ 3.1.2 Does the factory have ISO 9000 accreditation? 工廠(chang)是(shi)否經(jing)過ISO9000的認可(ke)？ 3.1.3 Does the factory have an appropriate documented quality policy which has been communicated, understood and is used by the factory? 工廠是否制定了恰當的(de)質量方針手(shou)冊，該手(shou)冊經過與(yu)員工的(de)溝通(tong)并且得(de)到(dao)員工的(de)理解(jie)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(ti)系是(shi)否有書面(mian)記(ji)錄(lu)、執行并得(de)到有效監督？ 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? 工廠是否制定并使用了恰當的質量(liang)管理(li)程序？ 3.2.4 Are there suitable document control processes in operation? 在操作中是否有恰當(dang)的文件控(kong)制程序？ 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? 是否(fou)在工廠內部進行了清楚的職責劃分(fen)并將其告知有(you)關人(ren)員？ 3.3.2 Is there an effective, empowered manager with QA authority? 工(gong)廠內是否有一個有效的、有力的質(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(jing)過合適的教育、培訓(xun)，并能(neng)勝(sheng)任他們所要做的工作？ 3.3.4 Do the workforce understand their part of the manufacturing process, are they trained, is training recorded and updated? 工(gong)人們(men)(men)是(shi)否(fou)理解他(ta)們(men)(men)所操作部分(fen)的制(zhi)造工(gong)藝(yi)，他(ta)們(men)(men)受過相關培訓嗎？培訓是(shi)否(fou)得到記錄并(bing)時常更新？ 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? 工廠目前(qian)使用的(de)(de)程序是否經過評(ping)估和(he)審查，這樣它可以和(he)工廠的(de)(de)質量管理方(fang)針保持一致(zhi)性？ 3.4.2 Are effective internal audits and necessary corrective actions implemented in appropriate timescales? 是(shi)否進行定期的(de)企業內審并(bing)采取(qu)了相應的(de)整改措施？ 3.4.3 Is an appropriate calibration process in place which is traceable and documented? 是否(fou)制定了一個恰當的校(xiao)準程序(xu)，該程序(xu)可被查詢并可被書面記錄？ 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? 客戶的(de)反饋(kui)是(shi)否得到關注、時常(chang)回(hui)顧(gu)并采取(qu)相(xiang)應措施？ 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)(sheng)產(chan)前及生(sheng)(sheng)產(chan)的(de)過程(cheng)中，對(dui)產(chan)品(pin)的(de)要(yao)求及工(gong)藝(yi)過程(cheng)進行(xing)審核，以確保(bao)達到客(ke)戶在產(chan)品(pin)安全性(xing)、恰(qia)當(dang)性(xing)以及產(chan)品(pin)標(biao)準和規格方面(mian)的(de)要(yao)求？ 3.6.2 Do appropriate 'Technical Files' exist? 是否制(zhi)定(ding)了相應的技(ji)術(shu)文件？ 3.6.3 Is pack wording reviewed for suitability before production? 生產(chan)前是否對包(bao)裝上的文字正確性進行(xing)了檢查(cha)？ 3.6.4 Are instructions reviewed for suitability before production? 生產前是否對說明書(shu)的正確性(xing)進行了檢查(cha)？ 3.6.5 Is there appropriate safety certification available for products being manufactured? 產品制造前是否(fou)獲得相關(guan)的安全證(zheng)書？ 3.6.6 Is there an effective design validation process in place for products being manufactured? 正在生產的產品(pin)是否有一個見效的設計確認(ren)程序？ 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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