| 3.1 |
Quality Policy 質(zhì)量方針 |
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| 3.1.1 |
Does the management demonstrate commitment to following an appropriate quality process? 管理層是否能證明他們嚴(yán)格執(zhí)行了相應(yīng)的質(zhì)量管理體系？ |
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| 3.1.2 |
Does the factory have ISO 9000 accreditation? 工廠是否經(jīng)過ISO9000的認(rèn)可？ |
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| 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(dāng)?shù)馁|(zhì)量方針手冊(cè)，該手冊(cè)經(jīng)過與員工的溝通并且得到員工的理解和使用？ |
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| 3.2 |
Implementation of Quality System 質(zhì)量管理體系的實(shí)行 |
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| 3.2.1 |
Is the quality management system documented, used and monitored? 該質(zhì)量管理體系是否有書面記錄、執(zhí)行并得到有效監(jiān)督？ |
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| 3.2.2 |
Is there an effective quality manual in place and used? 是否制定并使用了質(zhì)量管理手冊(cè)？ |
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| 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(dāng)?shù)馁|(zhì)量管理程序？ |
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| 3.2.4 |
Are there suitable document control processes in operation? 在操作中是否有恰當(dāng)?shù)奈募刂瞥绦颍?/FONT> |
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| 3.3 |
Competency, Training and Responsibility 能力、培訓(xùn)和責(zé)任 |
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| 3.3.1 |
Are responsibilities in the factory defined and known by the necessary people? 是否在工廠內(nèi)部進(jìn)行了清楚的職責(zé)劃分并將其告知有關(guān)人員？ |
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| 3.3.2 |
Is there an effective, empowered manager with QA authority? 工廠內(nèi)是否有一個(gè)有效的、有力的質(zhì)保負(fù)責(zé)人？ |
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| 3.3.3 |
Are the workforce suitably educated, trained, capable and experienced for the jobs they are required to do? 工人是否經(jīng)過合適的教育、培訓(xùn)，并能勝任他們所要做的工作？ |
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| 3.3.4 |
Do the workforce understand their part of the manufacturing process, are they trained, is training recorded and updated? 工人們是否理解他們所操作部分的制造工藝，他們受過相關(guān)培訓(xùn)嗎？培訓(xùn)是否得到記錄并時(shí)常更新？ |
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| 3.4 |
Measurement and Improvement 衡量和改進(jìn) |
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| 3.4.1 |
Are the procedures used assessed and reviewed, so that they are consistent with the quality policy of the factory? 工廠目前使用的程序是否經(jīng)過評(píng)估和審查，這樣它可以和工廠的質(zhì)量管理方針保持一致性？ |
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| 3.4.2 |
Are effective internal audits and necessary corrective actions implemented in appropriate timescales? 是否進(jìn)行定期的企業(yè)內(nèi)審并采取了相應(yīng)的整改措施？ |
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| 3.4.3 |
Is an appropriate calibration process in place which is traceable and documented? 是否制定了一個(gè)恰當(dāng)?shù)男?zhǔn)程序，該程序可被查詢并可被書面記錄？ |
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| 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(shí)別問題和違規(guī)？如果有的話，有沒有制定合適的改正、預(yù)防方案？ |
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| 3.5 |
Customer Focus 客戶 |
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| 3.5.1 |
Do processes exist which ensure customer needs, specifications and requirements are understood and met? 是否制定了相應(yīng)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？ |
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| 3.5.2 |
Is customer feedback monitored, reviewed and action taken? 客戶的反饋是否得到關(guān)注、時(shí)常回顧并采取相應(yīng)措施？ |
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| 3.6 |
Design & Development 設(shè)計(jì)和發(fā)展 |
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| 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? 是否在生產(chǎn)前及生產(chǎn)的過程中，對(duì)產(chǎn)品的要求及工藝過程進(jìn)行審核，以確保達(dá)到客戶在產(chǎn)品安全性、恰當(dāng)性以及產(chǎn)品標(biāo)準(zhǔn)和規(guī)格方面的要求？ |
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| 3.6.2 |
Do appropriate 'Technical Files' exist? 是否制定了相應(yīng)的技術(shù)文件？ |
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| 3.6.3 |
Is pack wording reviewed for suitability before production? 生產(chǎn)前是否對(duì)包裝上的文字正確性進(jìn)行了檢查？ |
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| 3.6.4 |
Are instructions reviewed for suitability before production? 生產(chǎn)前是否對(duì)說明書的正確性進(jìn)行了檢查？ |
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| 3.6.5 |
Is there appropriate safety certification available for products being manufactured? 產(chǎn)品制造前是否獲得相關(guān)的安全證書？ |
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| 3.6.6 |
Is there an effective design validation process in place for products being manufactured? 正在生產(chǎn)的產(chǎn)品是否有一個(gè)見效的設(shè)計(jì)確認(rèn)程序？ |
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| 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(jīng)檢查和授權(quán)的設(shè)計(jì)變更？ |
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