ISO-TS16949培訓(xùn)教材(共134頁(yè)).ppt

1、DNV - June 19991ISO/TS16949:2002課程課程 Quality & Satisfy 2Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999ISO/TS16949ISO/TS16949課程課程學(xué)員自我介紹包括學(xué)員自我介紹包括:姓名姓名公司及產(chǎn)品公司及產(chǎn)品在公司負(fù)責(zé)之工作在公司負(fù)責(zé)之工作對(duì)本課程之期望對(duì)本課程之期望 Quality & Satisfy 3Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999課堂要求 歡迎閣下參加本次課程

2、，本課程將為您打下一個(gè)良好的基礎(chǔ)，歡迎閣下參加本次課程，本課程將為您打下一個(gè)良好的基礎(chǔ)，提高您的能力和水平提高您的能力和水平.請(qǐng)注意以下的幾點(diǎn)：請(qǐng)注意以下的幾點(diǎn)：1、手提電話傳呼機(jī)、手提電話傳呼機(jī) 上課期間請(qǐng)將您的手提電話上課期間請(qǐng)將您的手提電話 和和 傳呼機(jī)開(kāi)為振動(dòng)或關(guān)閉傳呼機(jī)開(kāi)為振動(dòng)或關(guān)閉.2、吸煙、吸煙 在課堂內(nèi)請(qǐng)不要吸煙在課堂內(nèi)請(qǐng)不要吸煙.3、其它、其它 課期間請(qǐng)不要大聲喧嘩課期間請(qǐng)不要大聲喧嘩, 舉手提問(wèn)舉手提問(wèn), 不要隨意走動(dòng)不要隨意走動(dòng). Quality & Satisfy 4Q Qu ua al li it ty yS Sa at ti is sf fy yDNV -

3、June 1999引引 言言 一個(gè)公司的質(zhì)量問(wèn)題一個(gè)公司的質(zhì)量問(wèn)題- 94%歸咎于體系或管理原因歸咎于體系或管理原因 6%歸咎于偶發(fā)性原因歸咎于偶發(fā)性原因-戴明博士戴明博士 Quality & Satisfy 5Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999ISO/TS 16949:2002 ISO 9001:2000在汽車(chē)生產(chǎn)和相關(guān)服務(wù)件組織應(yīng)用的特殊要求在汽車(chē)生產(chǎn)和相關(guān)服務(wù)件組織應(yīng)用的特殊要求ISO/TS 16949：2002 隨著汽車(chē)產(chǎn)業(yè)日漸國(guó)際化，單一且可以被所有汽車(chē)制造業(yè)者接受的質(zhì)量管理系統(tǒng)愈顯重要。ISO/

4、TS 16949：2002的目標(biāo)就是創(chuàng)造一個(gè)整合現(xiàn)有汽車(chē)業(yè)質(zhì)量要求的管理系統(tǒng)。通過(guò) ISO/TS 16949：2002將可使廠商免去多重驗(yàn)證的麻煩。 ISO/TS 16949：2002是國(guó)際汽車(chē)推動(dòng)小組 (International Automotive Task Force ,IATF, ) 根據(jù)ISO 9001：2000對(duì)汽車(chē)產(chǎn)業(yè)供應(yīng)商所草擬的特定質(zhì)量系統(tǒng)要求。本標(biāo)準(zhǔn)的版權(quán)所有歸意大利ANFIA、法國(guó)CFA/FIEV、德國(guó)VDA以及美國(guó)的戴姆勒克萊斯勒、福特與通用等汽車(chē)廠所持有。 ISO/TS 16949：2002為一國(guó)際標(biāo)準(zhǔn)，但其目的與QS 9000和VDA6.1

5、等類似。 Quality & Satisfy 6Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999從從19961996年起，年起，IATF (International Automotive Task Force) IATF (International Automotive Task Force) 國(guó)際汽車(chē)工業(yè)行動(dòng)小組國(guó)際汽車(chē)工業(yè)行動(dòng)小組開(kāi)始著手協(xié)調(diào)汽車(chē)行業(yè)的質(zhì)量體系要求，開(kāi)始著手協(xié)調(diào)汽車(chē)行業(yè)的質(zhì)量體系要求， 19991999年發(fā)布了年發(fā)布了ISO/TS 16949ISO/TS 16949第一版，供汽車(chē)行業(yè)試行，并搜集第

6、一版，供汽車(chē)行業(yè)試行，并搜集使用中的信息和經(jīng)驗(yàn)。使用中的信息和經(jīng)驗(yàn)。經(jīng)過(guò)三年的試用，并在各國(guó)汽車(chē)組織的積極推動(dòng)下，經(jīng)過(guò)三年的試用，并在各國(guó)汽車(chē)組織的積極推動(dòng)下，IATFIATF成員成員組織共同對(duì)組織共同對(duì)ISO/TS 16949:1999ISO/TS 16949:1999進(jìn)行了修訂，并提交進(jìn)行了修訂，并提交ISOISO組織批組織批準(zhǔn)和出版。第二版準(zhǔn)和出版。第二版ISO/TS 16949:2002ISO/TS 16949:2002于于20022002年年3 3月月1 1日發(fā)布。日發(fā)布。ISO/TS 16949:2002ISO/TS 16949:2002是基于是基于ISO 9001:2000, A

7、VSQISO 9001:2000, AVSQ（意大利）意大利）, , EAQFEAQF（法國(guó)）法國(guó)）, , QS-9000QS-9000（美國(guó)）美國(guó)）, , VDA 6.1VDA 6.1（德國(guó)）而制定的德國(guó)）而制定的，ISO/TS 16949:2002 ISO/TS 16949:2002 與與顧客特定要求顧客特定要求一起構(gòu)成為汽車(chē)供應(yīng)鏈一起構(gòu)成為汽車(chē)供應(yīng)鏈的質(zhì)量體系要求。的質(zhì)量體系要求。一.IATF與ISO/TS 16949的產(chǎn)生 Quality & Satisfy 7Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999二二

8、.ISO/TS16949是什么是什么? 汽車(chē)業(yè)之工業(yè)標(biāo)準(zhǔn)汽車(chē)業(yè)之工業(yè)標(biāo)準(zhǔn) 由由IATF、JAMA及及ISO/TC 176支持所制定支持所制定 各地之監(jiān)督機(jī)構(gòu)各地之監(jiān)督機(jī)構(gòu):ANFIA(Italy)，IAOB （USA）,FIEV/CCFA (France),SMMT(UK), （VDA-QMC(Germany). 整合整合ISO9001：2000之要求之要求 于于2002-Mar-1發(fā)新版以配合發(fā)新版以配合ISO9001：2000架構(gòu)架構(gòu) 條文將涵蓋條文將涵蓋QS-9000、EAQF94、AVSQ94及及 VDA6.1等各國(guó)汽車(chē)工業(yè)標(biāo)準(zhǔn)（非百分之百涵蓋）等各國(guó)汽車(chē)工業(yè)標(biāo)準(zhǔn)（非百分之百涵蓋） Q

9、uality & Satisfy 8Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999ISO/TS16949是什么是什么? 汽車(chē)制造廠亦可認(rèn)證汽車(chē)制造廠亦可認(rèn)證TS16949 QS-9000將于將于2006-12-15失效，屆時(shí)許多公司將無(wú)法轉(zhuǎn)成失效，屆時(shí)許多公司將無(wú)法轉(zhuǎn)成TS16949 產(chǎn)品未交入汽車(chē)供應(yīng)鏈，汽車(chē)顧客未要求產(chǎn)品未交入汽車(chē)供應(yīng)鏈，汽車(chē)顧客未要求TS16949之工之工廠，廠，After Market工廠皆不能認(rèn)證工廠皆不能認(rèn)證TS16949（eligibility) AVSQ及及EAQF將于將于2003-12

10、-15失效失效 將協(xié)調(diào)各國(guó)汽車(chē)工業(yè)標(biāo)準(zhǔn)和歐洲將協(xié)調(diào)各國(guó)汽車(chē)工業(yè)標(biāo)準(zhǔn)和歐洲ISO GROUP及美國(guó)及美國(guó)QS-9000而成為全球汽車(chē)工業(yè)之共同標(biāo)準(zhǔn)而成為全球汽車(chē)工業(yè)之共同標(biāo)準(zhǔn) Ford，GM，Daimler Chrysler，BMW，F(xiàn)iat，PSA Peugeot-Citroen，Renault SA and Volkswagen 已支持已支持TS16949 Quality & Satisfy 9Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999三三. . Benefit of ISO/TS16949Provide add

11、itional confidence in Global sourcing1.Reduction in 2nd party audits2.Reduction in multiple 3rd party registrations3.Common quality system approach in the supply chain for development and consistency4.Freeing up of supplier resources for other quality activities5.Reduction of variation and increased

12、 efficiency6.Common language to improve understanding of quality requirements7.Improved product and process quality Quality & Satisfy 10Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999 實(shí)施實(shí)施ISO/TS 16949:2002ISO/TS 16949:2002可帶來(lái)以下好處：可帶來(lái)以下好處：ISO/TS 16949:2002ISO/TS 16949:2002注冊(cè)要求注冊(cè)要求為供應(yīng)鏈中的

13、供應(yīng)商為供應(yīng)鏈中的供應(yīng)商/分承包商的分承包商的持續(xù)改進(jìn)和一致性提供了共通的質(zhì)量管持續(xù)改進(jìn)和一致性提供了共通的質(zhì)量管理體系方法理體系方法減少為滿足不同客戶的要求而進(jìn)行減少為滿足不同客戶的要求而進(jìn)行的第三方重復(fù)認(rèn)證的第三方重復(fù)認(rèn)證提高產(chǎn)品質(zhì)量和過(guò)程質(zhì)量提高產(chǎn)品質(zhì)量和過(guò)程質(zhì)量增強(qiáng)全球采購(gòu)的信心增強(qiáng)全球采購(gòu)的信心有助于重新選定供貨源以提高質(zhì)量有助于重新選定供貨源以提高質(zhì)量z全球的汽車(chē)制造商們已紛紛制訂了注冊(cè)計(jì)劃要求 Quality & Satisfy 11Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999四四.ISO/TS1694

14、9相關(guān)標(biāo)準(zhǔn)相關(guān)標(biāo)準(zhǔn)ISO/TS16949Quality management systems,2002-03-01IATF Guidance to ISO/TS16949:2002,edition 1Quality system assessment checklist to ISO/TS16949:2002,ed 1Automotive certification scheme for ISO/TS16949,2002-3-19ISO9004:2000,Guidelines for performance improvementsISO19011,Guidelines on quality

15、and/or environmental managements auditingISO10012-1:1992,quality assurance requirements for measuring equipment-part 1:Metrological confirmation system for measuring equipment ISO10012-2:1997,Quality Assurance for measuring equipment part 2:Guidelines for control of measurement processesISO/IEC17025

16、:1999,General requirements for the competence of testing and calibration laboratories Quality & Satisfy 12Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999五五.OEM廠對(duì)廠對(duì)TS16949之要求之要求Daimler Chrysler require certification to ISO/TS16949:2002 by all suppliers by 2004-7-1Ford &GM require ce

17、rtification to ISO/TS16949:2002 by 2006- 12-15PSA Peugeot-Citroen require certification to ISO/TS16949:2002 by 2004-7-1.(TS1 to TS2, 2004-12-15)Renault require certification to ISO/TS16949:2002 by 2004-7-1. (TS1 to TS2, 2004-12-15) Fiat require certification to ISO/TS16949:1999 or ISO/TS16949:2002 f

18、rom now.Volkswagen require certification to either ISO/TS16949:2002 or VDA6.1BMW require compliance to either ISO/TS16949:2002or VDA6.1/QS9000Nissan,because of their link with Renault,require compliance to ISO/TS16949:2002 Other Japanese manufacturers dont require ISO/TS16949:2002 as a supplier appr

19、oval process,but may reduce second party audits if an supplier is ISO/TS16949:2002 certified Quality & Satisfy 13Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999六六.ISO/TS 16949:2002 標(biāo)準(zhǔn)的沿革標(biāo)準(zhǔn)的沿革Reduced expenditure for a supplier with a QS9000 and VDA6.1-certificates意大利AVSQ法國(guó)EAQF德國(guó)VDA6.1美國(guó)

20、 QS-9000ISO/TS 16949技術(shù)規(guī)范ISO/TS 16949:2002質(zhì)量管理體系 - 汽車(chē)行業(yè)生產(chǎn)件與相關(guān)服務(wù)件的組織實(shí)施ISO 9001：2000的特殊要求ISO 9001:2000以ISO 9001:2000為框架基礎(chǔ),綜合了AVSQ, EAQF, VDA6.1, QS-9000，制定了ISO/TS 16949:2002技術(shù)規(guī)范。 Quality & Satisfy 14Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999SMMT (GB)BS 5750ISO 9000QS-9000VDA (Germany

21、)1970198019902000VDA 6AIAG (USA)9487797299ANFIA (Italy)CCFA / FIEV (France)AVSQEAQFISO 9000IATFISO/ TS 169499602ISO/ TS 16949:2002ISO 9000JAMAISO/TC176 ISO/TS 16949:2002 標(biāo)準(zhǔn)的沿革標(biāo)準(zhǔn)的沿革 Quality & Satisfy 15Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999七七.ISO/TS16949的目標(biāo)的目標(biāo)v強(qiáng)調(diào)缺失預(yù)防強(qiáng)調(diào)缺失預(yù)防v減少變異

22、及浪費(fèi)減少變異及浪費(fèi)v持續(xù)改進(jìn)持續(xù)改進(jìn) Quality & Satisfy 16Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999八八.ISO/TS16949架構(gòu)架構(gòu)Fundamental（ISO9001）PartCommodityDivisionCompany（Ford Q-1）Sector（ISO/TS16949）More Specific Quality & Satisfy 17Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999九.誰(shuí)可以執(zhí)行TS

23、16949之評(píng)審及發(fā)證 IATF所認(rèn)可的認(rèn)證機(jī)構(gòu)，全球共48家，可在上網(wǎng)查詢 QS-9000證書(shū)全球共發(fā)出22000張（500 in PRC,500 in Taiwan),TS16949：99證書(shū)為1700張（most in Europe） IATF嚴(yán)格限制新的認(rèn)可機(jī)構(gòu)，除非有人被除權(quán)否則難以進(jìn)入此認(rèn)可的認(rèn)證機(jī)構(gòu)名單 BSI、DNV、TUN、BVQI、UL、Lloyds、SGS、Intertek、Entelaetc皆有資格發(fā)證 Quality & Satisfy 18Q Qu ua al li it ty yS Sa at ti is sf fy yDNV -

24、June 1999十十.ISO/TS16949提出的發(fā)現(xiàn)提出的發(fā)現(xiàn) 主要缺點(diǎn)：（主要缺點(diǎn)：（1）體系崩潰（）體系崩潰（2）喪失對(duì)制程的）喪失對(duì)制程的控制能力（控制能力（3）將不合格品送交顧客）將不合格品送交顧客 次要缺點(diǎn)次要缺點(diǎn) 改進(jìn)機(jī)會(huì)改進(jìn)機(jī)會(huì) 審核結(jié)論審核結(jié)論 無(wú)主要或次要缺點(diǎn)：建議發(fā)證 任何缺點(diǎn)：須提供書(shū)面糾正預(yù)防報(bào)告或進(jìn)行跟進(jìn)評(píng)審，審核通過(guò)才宣布建議發(fā)證。 Quality & Satisfy 19Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999十十.ISO/TS16949之評(píng)審流程之評(píng)審流程 符合符合Eligib

25、ility Requirement之工廠之工廠 12個(gè)月之個(gè)月之TS16949/QS-9000/VDA體系績(jī)效記錄體系績(jī)效記錄 至少一次之管理評(píng)審及內(nèi)部審核，并確認(rèn)體系至少一次之管理評(píng)審及內(nèi)部審核，并確認(rèn)體系之績(jī)效與效率可接受之績(jī)效與效率可接受 提出申請(qǐng)？報(bào)價(jià)？召集評(píng)審小組？文件評(píng)審（文件評(píng)審（須為現(xiàn)場(chǎng)評(píng)審，正審須為現(xiàn)場(chǎng)評(píng)審，正審3個(gè)月前）？個(gè)月前）？預(yù)評(píng)（可選擇）？建立評(píng)審計(jì)劃？現(xiàn)場(chǎng)評(píng)審？提出評(píng)審報(bào)告？缺失改進(jìn)？評(píng)審小組確認(rèn)？總部否決權(quán)審核？發(fā)出證書(shū) Quality & Satisfy 20Q Qu ua al li it ty yS Sa at ti is sf fy yDNV -

26、 June 1999汽車(chē)業(yè)之特點(diǎn)汽車(chē)業(yè)之特點(diǎn) 汽車(chē)零件汽車(chē)零件80%之質(zhì)量問(wèn)題及之質(zhì)量問(wèn)題及70%之成本低減取之成本低減取決于設(shè)計(jì)與開(kāi)發(fā)決于設(shè)計(jì)與開(kāi)發(fā) 汽車(chē)制造廠（汽車(chē)制造廠（OEM）80%之問(wèn)題為一階供貨之問(wèn)題為一階供貨商（商（Tier-1 supplier）所造成，一階供貨商所造成，一階供貨商80%之問(wèn)題為二階供貨商（之問(wèn)題為二階供貨商（Tier-2 supplier）所造成所造成 開(kāi)發(fā)期越來(lái)越短（開(kāi)發(fā)期越來(lái)越短（18 months）？）？共享底盤(pán)，共享底盤(pán)，車(chē)廠合并車(chē)廠合并 Quality & Satisfy 21Q Qu ua al li it ty yS Sa at ti i

27、s sf fy yDNV - June 1999ISO/TS16949條文說(shuō)明條文說(shuō)明 ISO9001：2000之條文不在此描述之條文不在此描述 下標(biāo)字者為下標(biāo)字者為T(mén)S16949特有要求特有要求 不再使用不再使用“Should”字眼，所有要求皆為字眼，所有要求皆為“Shall”之強(qiáng)制要求之強(qiáng)制要求 文件化程序之要求包括訓(xùn)練文件化程序之要求包括訓(xùn)練 Quality & Satisfy 22Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999與與QS-9000之不同點(diǎn)之不同點(diǎn) ISO9001：2000架構(gòu)及過(guò)程方法（架構(gòu)及過(guò)程

28、方法（process approach） 更強(qiáng)調(diào)顧客導(dǎo)向更強(qiáng)調(diào)顧客導(dǎo)向 員工激勵(lì)與質(zhì)量意識(shí)員工激勵(lì)與質(zhì)量意識(shí) 目標(biāo)成本，降低成本之要求目標(biāo)成本，降低成本之要求 提升供貨商制程績(jī)效之監(jiān)督提升供貨商制程績(jī)效之監(jiān)督 可靠度目標(biāo)可靠度目標(biāo) 更多地方體現(xiàn)精實(shí)生產(chǎn)之精神更多地方體現(xiàn)精實(shí)生產(chǎn)之精神 Quality & Satisfy 23Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999顧客導(dǎo)向顧客導(dǎo)向過(guò)程方法之顧客導(dǎo)向過(guò)程方法之顧客導(dǎo)向Organization顧顧 客客顧顧 客客Organization Quality & S

29、atisfy 24Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999顧客導(dǎo)向流程顧客導(dǎo)向流程顧客拿到報(bào)價(jià)單顧客要求報(bào)價(jià) Quality & Satisfy 25Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999小組小組COP練習(xí)練習(xí)請(qǐng)列出一家修車(chē)廠會(huì)有哪些顧客導(dǎo)向流請(qǐng)列出一家修車(chē)廠會(huì)有哪些顧客導(dǎo)向流程？程？ Quality & Satisfy 26Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June

30、1999Different Types of Processes不同類型的過(guò)程不同類型的過(guò)程qKey Processes 關(guān)鍵過(guò)程qSupport Processes 支持性過(guò)程qManagement Processes管理過(guò)程 Quality & Satisfy 27Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999Key Processes 關(guān)鍵過(guò)程關(guān)鍵過(guò)程 Any process which directly relates to an interface between an organization and it

31、s customer 任何與組織及其顧客的接口直接相關(guān)的過(guò)程 Critical to the achievement of Customer Satisfaction 實(shí)現(xiàn)顧客滿意的過(guò)程 Involves an input from the customer and an output to the customer 與從顧客的輸入到對(duì)顧客的輸出有關(guān)的過(guò)程 Quality & Satisfy 28Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999Support Processes支持性過(guò)程支持性過(guò)程 Each Key Pr

32、ocess will be supplemented by one or more support processes 每一個(gè)關(guān)鍵過(guò)程都會(huì)有一個(gè)或多個(gè)支持過(guò)程來(lái)補(bǔ)充 Support processes would generally have internal customers and suppliers 支持性過(guò)程一般都有內(nèi)部的顧客和供方 Examples of support processes could be: 支持性過(guò)程舉例： Training培訓(xùn) Document Control文件控制 Quality & Satisfy 29Q Qu ua al li it ty yS

33、 Sa at ti is sf fy yDNV - June 1999Management Processes管理過(guò)程管理過(guò)程 May be Support Processes 可以是支持性過(guò)程 Are generally processes which manage the organisation or its quality 一般是對(duì)組織或其質(zhì)量體系進(jìn)行管理的過(guò)程 Examples of management processes could be: 管理過(guò)程舉例: Business Pianning經(jīng)營(yíng)計(jì)劃 Management Revies管理評(píng)審 Quality & Sati

34、sfy 30Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999流程型態(tài)流程型態(tài)Support ProcessesManagement ProcessesCore Processes Quality & Satisfy 31Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999流程型態(tài)之范例流程型態(tài)之范例Quality Maintenance Information Assurance ManagementDesignPurchasingServiceProduct

35、ionPlanningDistribution Personnel Management Finance Planning by Objectives PlanningProduction Quality & Satisfy 32Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999小組小組“過(guò)程鑒別過(guò)程鑒別”練習(xí)練習(xí)請(qǐng)列出貴公司質(zhì)量管理體系之過(guò)程，請(qǐng)列出貴公司質(zhì)量管理體系之過(guò)程，并標(biāo)示其為關(guān)鍵，支持或管理過(guò)程并標(biāo)示其為關(guān)鍵，支持或管理過(guò)程 Quality & Satisfy 33Q Qu ua al li it ty

36、 yS Sa at ti is sf fy yDNV - June 1999以流程為基礎(chǔ)之質(zhì)量管理體系模式以流程為基礎(chǔ)之質(zhì)量管理體系模式質(zhì)量管理體系持續(xù)改進(jìn)管理職責(zé)資源管理產(chǎn)品實(shí)現(xiàn)測(cè)量、分析與改進(jìn)產(chǎn) 品顧客要求顧客滿意度信息輸入輸出信息增值活動(dòng)增值活動(dòng) Quality & Satisfy 34Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999流程解析流程解析顧客導(dǎo)向流程CustomerOrientedProcess管理流程ManagementProcess支持流程Support Process Quality &

37、Satisfy 35Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999以流程為基礎(chǔ)之質(zhì)量管理體系模式以流程為基礎(chǔ)之質(zhì)量管理體系模式質(zhì)量管理體系持續(xù)改進(jìn)管理職責(zé)資源管理產(chǎn)品實(shí)現(xiàn)測(cè)量、分析與改進(jìn)產(chǎn) 品顧客要求顧客滿意度信息輸入輸出信息增值活動(dòng)增值活動(dòng) Quality & Satisfy 36Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999ISO/TS16949第第4章章 通則：通則： 在在TS16949體系，僅可排除體系，僅可排除7.3設(shè)計(jì)控制設(shè)計(jì)控制 制程設(shè)計(jì)

38、不得排除制程設(shè)計(jì)不得排除 有關(guān)有關(guān)TS16949之運(yùn)用，另可參考之運(yùn)用，另可參考“IATF Guidance to ISO/TS16949:2002” TS16949亦可運(yùn)用于協(xié)力廠商鏈中之所有工廠亦可運(yùn)用于協(xié)力廠商鏈中之所有工廠 4.1.1(一般要求一般要求-補(bǔ)充補(bǔ)充)對(duì)于外包制程之控制的確對(duì)于外包制程之控制的確保，外包不能免除組織提供符合顧客所有要求保，外包不能免除組織提供符合顧客所有要求之產(chǎn)品的責(zé)任之產(chǎn)品的責(zé)任 Quality & Satisfy 37Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999ISO/TS16

39、949第第4章章建立書(shū)面程序之需求將于各章節(jié)規(guī)定(工程規(guī)范)組織必須建立過(guò)程以保證按照顧客要求的時(shí)間表及評(píng)審、發(fā)放和實(shí)施所有顧客的工程標(biāo)準(zhǔn)/規(guī)范及基于顧客要求時(shí)間進(jìn)度的更改。應(yīng)該盡快進(jìn)行及時(shí)的評(píng)審，時(shí)間必須不能超過(guò)兩個(gè)工作周。保存每項(xiàng)更改在生產(chǎn)中實(shí)施的日期的記錄。包括對(duì)所有適當(dāng)文件的更新（p.s ECN from customer,C/P action,field failure?timely review?Re-PPAP?update document?introduce in production?OJT?obsolete product quarantined in war

40、ehouse?p.s.在生產(chǎn)中實(shí)施的日期是指生產(chǎn)日期或臺(tái)數(shù),非變更發(fā)布日期(記錄保存)質(zhì)量記錄之保存期需符合法規(guī)及顧客要求 Quality & Satisfy 38Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999何謂過(guò)程方法？何謂過(guò)程方法？qProcess ApproachWith what用哪些With who跟誰(shuí)做Output輸出Process過(guò)程How如何做Input輸入What result量度方法/指標(biāo) Quality & Satisfy 39Q Qu ua al li it ty yS

41、Sa at ti is sf fy yDNV - June 1999過(guò)程方法演練過(guò)程方法演練Quotation process:Input:Customer requirement,Regulation,Business plan,Previous experience,Customer Rep.Output:Quotation report on timeWith what:BOM,Trained staff,Spec,FMEA,Material price listHow:SOP,Risk analysis methodWith who:Top management,Purchasing,

42、Engineering,Bank,Accountant,HR,QA,Legislation expert,Financial,CustomerWhat result:Response cycle,error rate,Conversion rate with good profit,Quotation case Quality & Satisfy 40Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999小組小組“過(guò)程方法過(guò)程方法”練習(xí)練習(xí) 請(qǐng)以過(guò)程方法分析車(chē)廠安全氣囊設(shè)計(jì)過(guò)程 Quality & Satisfy 41

43、Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999過(guò)程方法演練過(guò)程方法演練Process:Air conditioning systemInput:Customer requirement,Regulation,Business plan,Bench market(price),FMEA,Aimed market climate,Requirements from counterparts,Department/product target.Output:D-FMEA,Engineering Drawings,Test Spec,

44、Consistency concerns with counterparts,Guidance for maintainability.With what:Competent human resource,DFM/DFA data,CAD,Testing facility,Prototype,Previous experience(TGW,TGR),Timing chart,DOE,Design skils,SPC tech,Error proofing,Problem solving tech. Quality & Satisfy 42Q Qu ua al li it ty yS S

45、a at ti is sf fy yDNV - June 1999過(guò)程方法演練過(guò)程方法演練How:Design control procedure,Relative SOP,Multi-Disciplinary approach.With who:Top management,Purchasing,Supplier,HR,QA,Legislation expert,Service,Sales,Government expert, Doc controller,Lab,Other design teams,Production,Development,Tooling,Equipment.What

46、 result:Lead time,Product cost,Design cost,reliability,Durability,Maintainability,ppm,First pass rate,Error on spec. Quality & Satisfy 43Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999過(guò)程之量度指標(biāo)（過(guò)程之量度指標(biāo)（1）Quotation:Reply time,error rate.Sales:Quotation turn over,quotation case,sales volum

47、e,Profit,customer satisfaction rating,service response time.Customer complaint:Response time,reject rate,repeated problem case.Production scheduling:Production efficiency,productivity,lead time,delay rate,operation cost.Production:Production efficiency,poor quality cost,Kaizen cases,OJT achievement,

48、Cpk Quality & Satisfy 44Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999過(guò)程之量度指標(biāo)（過(guò)程之量度指標(biāo)（2）Quality Assurance:Customer complaint cases,poor quality cost,defect rate,lead time for problem solving,operation cost.Training:Training accomplishment,pass rate for evaluation,Human error cases in

49、defect.Tooling:Tooling change time,tooling defect rate,repair time.Employee motivation:Quit rate,absenteeism,Quality objective achievement in each section,employee satisfaction survey,Kaizen cases,annual interview,5S rating. Quality & Satisfy 45Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - Jun

50、e 1999過(guò)程之量度指標(biāo)（過(guò)程之量度指標(biāo)（3）Purchasing:Supplier quality/delivery performance,cost down,development achievement.R&D:Cost,lead time,critical path,quality risk,operation cost,complaint due to R&D,va/ve cases,skill training.Logistic:Stock turn over,inventory corrective rate,scrap/rework cost.Mainten

51、ance:OEE,machine down time.Measuring device:%R&R target.Shipping:On-time delivery,premium freight. Quality & Satisfy 46Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999ISO/TS16949第第5章章5.1.1(過(guò)程效率)最高管理者必須評(píng)審產(chǎn)品實(shí)現(xiàn)過(guò)程和支持過(guò)程，以確保產(chǎn)品實(shí)現(xiàn)的有效性和效率 （p.s Using process approach methodology to setup meas

52、urement for each process,monitor these measurement,check performance trend,M-Review,Boss just need numbers.) (p.s.Need to identify key processes and support processes on QMS.)5.3.(質(zhì)量方針)質(zhì)量政策需提及質(zhì)量體系之持續(xù)改進(jìn)（ISO9001：2000 clause) Quality & Satisfy 47Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June

53、1999ISO/TS16949第第5章章(質(zhì)量目標(biāo)-補(bǔ)充)業(yè)務(wù)計(jì)劃須確定質(zhì)量目標(biāo)，以開(kāi)展質(zhì)量方針（note:address customer expectation and in timely frame)(質(zhì)量責(zé)任)不符合規(guī)范要求的產(chǎn)品或過(guò)程，必須迅速通知給負(fù)有糾正措施職責(zé)和權(quán)限的管理者。負(fù)責(zé)產(chǎn)品質(zhì)量的人員，為了糾正質(zhì)量問(wèn)題，必須有權(quán)停止生產(chǎn)。所有班次的生產(chǎn)操作，必須指定負(fù)責(zé)人員（p.s.All shifts audit,lead time control,record of C/P action,FMEA,reaction plan,lean productio

54、n spirit)(顧客代表)指定某一或多位人員來(lái)代表顧客，傳遞相關(guān)需求（P.S.To ask his understanding about OEM requirements,s/c definition) Quality & Satisfy 48Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999ISO/TS16949第第5章章 5.6管理評(píng)審：（1）市場(chǎng)退回及其對(duì)質(zhì)量，安全及環(huán)保之沖擊需列入討論（2）需包含評(píng)審所有質(zhì)量體系要素及其績(jī)效（持續(xù)改進(jìn)之依據(jù)）（3）需包含對(duì)質(zhì)量目標(biāo)之監(jiān)視及質(zhì)量不良成本之報(bào)告與分析

55、（4）結(jié)論需予以記錄，以證明以下之達(dá)成狀況：（a）業(yè)務(wù)計(jì)劃所定之質(zhì)量目標(biāo)（b）顧客滿意度（p.s.poor quality cost?ice mountain?window lifter module,why need review impact in safety/environment?FMEA review?)(p.s.shall include summary result of APQP as an input)(p.s.customer focus 5.2)(p.s.why discuss internal audit&preventive action?)

56、(p.s.monthly QA meeting can be a M-review?)(p.s.SMD design & lot-out) Quality & Satisfy 49Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999管理評(píng)審管理評(píng)審補(bǔ)充補(bǔ)充為何不良質(zhì)量成本要列入管理評(píng)審中做討論？是否可用質(zhì)量成本來(lái)取代?每月品管會(huì)議可不可以代替管理評(píng)審?為何市場(chǎng)退回要列入管理評(píng)審中做討論？如何評(píng)估組織是否有落實(shí)顧客導(dǎo)向流程？ Quality & Satisfy 50Q Qu ua al li it ty yS

57、Sa at ti is sf fy yDNV - June 1999ISO/TS16949 第第6章章(產(chǎn)品設(shè)計(jì)技能)必須確保負(fù)有產(chǎn)品設(shè)計(jì)職責(zé)的人員有能力達(dá)到設(shè)計(jì)要求并熟練地掌握適用的工具和技術(shù)，組織須識(shí)別適用的工具和技術(shù)（p.s tools:QFD DOE,FMEA,CAD/CAEetc,D-FMEA weak in most of companies,Technique:knowledge and experience in product.)(培訓(xùn))必須建立并保持形成文件的程序，識(shí)別培訓(xùn)需求，所有從事對(duì)產(chǎn)品質(zhì)量有影響的工作的人員具有能力。從事特定工作的人員的資

58、格，必須進(jìn)行考核。（設(shè)計(jì)人員、改進(jìn)小組、實(shí)驗(yàn)室人員、色差檢驗(yàn)員、內(nèi)審人員等）。并且這種考核應(yīng)對(duì)顧客要求的滿足特別加以關(guān)注（p.s.ask customer representative,APQP input,contract review,typical requirement of customer:the application of digitized, math-based data ?) Quality & Satisfy 51Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999ISO/TS16949 第第6章章

59、OJT對(duì)所有影響產(chǎn)品質(zhì)量的工作，組織必須對(duì)新到職或調(diào)整工作的工作人員提供適當(dāng)?shù)脑诼毰嘤?xùn)，包括合同工和代理工作人員。必須告知其工作影響質(zhì)量的人員不符合質(zhì)量標(biāo)準(zhǔn)對(duì)顧客造成的后果（p.s.APQP?PPAP?Job setup verification for new,Lean production ILU training,ECN?operation change?OJT apply) (p.s. Falling umbrella story?Top management for quality com.) (員工激勵(lì)和授權(quán))組織必須建立一個(gè)促進(jìn)員工實(shí)現(xiàn)質(zhì)量目標(biāo)、進(jìn)行持續(xù)改進(jìn)和建立促

60、進(jìn)創(chuàng)新的環(huán)境的過(guò)程。該過(guò)程必須包括促進(jìn)整個(gè)組織對(duì)質(zhì)量和技術(shù)的認(rèn)知。（p.s.Ask high level management.designer and operators,check the achievement of performance in M.review.see innovation and CI cases.training plan) (p.s.How to motivate employee?Training,reward,stock share,promotion,facility establish,good company culture.QCC campaign,morning meetingetc.) (p.s. Day/shift production leader write number on ground) Quality & Satisfy 52Q Qu ua al li it ty yS Sa at ti is sf fy yDNV - June 1999OJT-Competence Mapq多功能訓(xùn)練表：qI：未熟悉，L：可勝任，U：純熟，O：可教導(dǎo)他人作業(yè) #1作業(yè)#2作業(yè)#3