ISO-TS16949培訓(xùn)教材(-134張)課件

1、QualitySatisfyISO/TS16949:2002課程DNV - June 19991ISO/TS16949:2002課程DNV - June ISO/TS16949課程學(xué)員自我介紹包括:姓名公司及產(chǎn)品在公司負(fù)責(zé)之工作對(duì)本課程之期望DNV - June 1999ISO/TS16949課程學(xué)員自我介紹包括:DNV - Ju課堂要求 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.請(qǐng)注意以下的幾點(diǎn)：1、手提電話傳呼機(jī) 上課期間請(qǐng)將您的手提電話 和 傳呼機(jī)開(kāi)為振動(dòng)或關(guān)閉.2、吸煙 在課堂內(nèi)請(qǐng)不要吸煙.3、其它 課期間請(qǐng)不要大聲喧嘩, 舉手提問(wèn), 不要隨意走動(dòng).DN

2、V - June 1999課堂要求DNV - June 1999引 言 一個(gè)公司的質(zhì)量問(wèn)題- 94%歸咎于體系或管理原因 6%歸咎于偶發(fā)性原因-戴明博士DNV - June 1999引 言 -戴明博士DNV - JuISO/TS 16949:2002 ISO 9001:2000在汽車生產(chǎn)和相關(guān)服務(wù)件組織應(yīng)用的特殊要求ISO/TS 16949：2002隨著汽車產(chǎn)業(yè)日漸國(guó)際化，單一且可以被所有汽車制造業(yè)者接受的質(zhì)量管理系統(tǒng)愈顯重要。ISO/TS 16949：2002的目標(biāo)就是創(chuàng)造一個(gè)整合現(xiàn)有汽車業(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

3、 16949：2002是國(guó)際汽車推動(dòng)小組 (International Automotive Task Force ,IATF, ) 根據(jù)ISO 9001：2000對(duì)汽車產(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等類似。DNV - June 1999ISO/TS 16949:2002 ISO 9001:20從1996年起，IATF (International Automotive Task Fo

4、rce) 國(guó)際汽車工業(yè)行動(dòng)小組開(kāi)始著手協(xié)調(diào)汽車行業(yè)的質(zhì)量體系要求， 1999年發(fā)布了ISO/TS 16949第一版，供汽車行業(yè)試行，并搜集使用中的信息和經(jīng)驗(yàn)。經(jīng)過(guò)三年的試用，并在各國(guó)汽車組織的積極推動(dòng)下，IATF成員組織共同對(duì)ISO/TS 16949:1999進(jìn)行了修訂，并提交ISO組織批準(zhǔn)和出版。第二版ISO/TS 16949:2002于2002年3月1日發(fā)布。ISO/TS 16949:2002是基于ISO 9001:2000, AVSQ（意大利）, EAQF（法國(guó)）, QS-9000（美國(guó)）, VDA 6.1（德國(guó)）而制定的，ISO/TS 16949:2002 與顧客特定要求一起構(gòu)成為汽車

5、供應(yīng)鏈的質(zhì)量體系要求。一.IATF與ISO/TS 16949的產(chǎn)生DNV - June 1999從1996年起，IATF (International Au二.ISO/TS16949是什么?汽車業(yè)之工業(yè)標(biāo)準(zhǔn)由IATF、JAMA及ISO/TC 176支持所制定各地之監(jiān)督機(jī)構(gòu):ANFIA(Italy)，IAOB （USA）,FIEV/CCFA (France),SMMT(UK), （VDA-QMC(Germany).整合ISO9001：2000之要求于2002-Mar-1發(fā)新版以配合ISO9001：2000架構(gòu)條文將涵蓋QS-9000、EAQF94、AVSQ94及 VDA6.1等各國(guó)汽車工業(yè)標(biāo)準(zhǔn)（

6、非百分之百涵蓋）DNV - June 1999二.ISO/TS16949是什么?DNV - June 19ISO/TS16949是什么?汽車制造廠亦可認(rèn)證TS16949QS-9000將于2006-12-15失效，屆時(shí)許多公司將無(wú)法轉(zhuǎn)成TS16949產(chǎn)品未交入汽車供應(yīng)鏈，汽車顧客未要求TS16949之工廠，After Market工廠皆不能認(rèn)證TS16949（eligibility)AVSQ及EAQF將于2003-12-15失效將協(xié)調(diào)各國(guó)汽車工業(yè)標(biāo)準(zhǔn)和歐洲ISO GROUP及美國(guó)QS-9000而成為全球汽車工業(yè)之共同標(biāo)準(zhǔn)Ford，GM，Daimler Chrysler，BMW，F(xiàn)iat，PSA

7、Peugeot-Citroen，Renault SA and Volkswagen 已支持TS16949DNV - June 1999ISO/TS16949是什么?DNV - June 1999三. Benefit of ISO/TS16949Provide additional confidence in Global sourcing1.Reduction in 2nd party audits2.Reduction in multiple 3rd party registrations3.Common quality system approach in the supply chain

8、 for development and consistency4.Freeing up of supplier resources for other quality activities5.Reduction of variation and increased efficiency6.Common language to improve understanding of quality requirements7.Improved product and process qualityDNV - June 1999三. Benefit of ISO/TS16949DNV -實(shí)施ISO/T

9、S 16949:2002可帶來(lái)以下好處：ISO/TS 16949:2002注冊(cè)要求為供應(yīng)鏈中的供應(yīng)商/分承包商的持續(xù)改進(jìn)和一致性提供了共通的質(zhì)量管理體系方法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)的信心有助于重新選定供貨源以提高質(zhì)量全球的汽車制造商們已紛紛制訂了注冊(cè)計(jì)劃要求DNV - June 1999實(shí)施ISO/TS 16949:2002可帶來(lái)以下好處：ISO四.ISO/TS16949相關(guān)標(biāo)準(zhǔn)ISO/TS16949Quality management systems,2002-03-01IATF Guidance to ISO/TS16949:2002

10、,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 and/or environmental managements auditingISO10012-1:1992,quality assurance requirements fo

11、r 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/IEC17025:1999,General requirements for the competence of testing and calibration laboratoriesDNV -

12、 June 1999四.ISO/TS16949相關(guān)標(biāo)準(zhǔn)ISO/TS16949Qu五.OEM廠對(duì)TS16949之要求Daimler Chrysler require certification to ISO/TS16949:2002 by all suppliers by 2004-7-1Ford &GM require certification to ISO/TS16949:2002 by 2006- 12-15PSA Peugeot-Citroen require certification to ISO/TS16949:2002 by 2004-7-1.(TS1 to TS2, 2004

13、-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 from now.Volkswagen require certification to either ISO/TS16949:2002 or VDA6.1BMW require compliance to either ISO/TS16949:2002or VDA6.1/Q

14、S9000Nissan,because of their link with Renault,require compliance to ISO/TS16949:2002 Other Japanese manufacturers dont require ISO/TS16949:2002 as a supplier approval process,but may reduce second party audits if an supplier is ISO/TS16949:2002 certifiedDNV - June 1999五.OEM廠對(duì)TS16949之要求Daimler Chrys

15、六.ISO/TS 16949:2002 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) QS-9000ISO/TS 16949技術(shù)規(guī)范ISO/TS 16949:2002質(zhì)量管理體系 - 汽車行業(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。DNV -

16、 June 1999六.ISO/TS 16949:2002 標(biāo)準(zhǔn)的沿革ReduSMMT (GB)BS 5750ISO 9000QS-9000VDA (Germany)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DNV - June 1999SMMT (GB)BS 5750ISO 9000QS-9

17、00七.ISO/TS16949的目標(biāo)強(qiáng)調(diào)缺失預(yù)防減少變異及浪費(fèi)持續(xù)改進(jìn)DNV - June 1999七.ISO/TS16949的目標(biāo)強(qiáng)調(diào)缺失預(yù)防DNV - Ju八.ISO/TS16949架構(gòu)Fundamental（ISO9001）PartCommodityDivisionCompany（Ford Q-1）Sector（ISO/TS16949）More SpecificDNV - June 1999八.ISO/TS16949架構(gòu)Fundamental（ISO九.誰(shuí)可以執(zhí)行TS16949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

18、 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DNV - June 1999九.誰(shuí)可以執(zhí)行TS16949之評(píng)審及發(fā)證IATF所認(rèn)可的認(rèn)證十.ISO/TS16949提出的發(fā)現(xiàn)主要缺點(diǎn)：（1）體系崩潰（2）喪失對(duì)制程的控制能力（3）將不合格品送交顧客次要缺點(diǎn)改進(jìn)機(jī)會(huì)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

19、核通過(guò)才宣布建議發(fā)證。DNV - June 1999十.ISO/TS16949提出的發(fā)現(xiàn)主要缺點(diǎn)：（1）體系崩潰十.ISO/TS16949之評(píng)審流程符合Eligibility Requirement之工廠12個(gè)月之TS16949/QS-9000/VDA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（須為現(xiàn)場(chǎng)評(píng)審，正審3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)DNV - June 1999十.ISO/TS16949之評(píng)審流程符合Eligibilit汽車業(yè)之特點(diǎn)汽車

20、零件80%之質(zhì)量問(wèn)題及70%之成本低減取決于設(shè)計(jì)與開(kāi)發(fā)汽車制造廠（OEM）80%之問(wèn)題為一階供貨商（Tier-1 supplier）所造成，一階供貨商80%之問(wèn)題為二階供貨商（Tier-2 supplier）所造成開(kāi)發(fā)期越來(lái)越短（18 months）？共享底盤(pán)，車廠合并DNV - June 1999汽車業(yè)之特點(diǎn)汽車零件80%之質(zhì)量問(wèn)題及70%之成本低減取決于ISO/TS16949條文說(shuō)明ISO9001：2000之條文不在此描述下標(biāo)字者為TS16949特有要求不再使用“Should”字眼，所有要求皆為“Shall”之強(qiáng)制要求文件化程序之要求包括訓(xùn)練DNV - June 1999ISO/TS169

21、49條文說(shuō)明DNV - June 1999與QS-9000之不同點(diǎn)ISO9001：2000架構(gòu)及過(guò)程方法（process approach）更強(qiáng)調(diào)顧客導(dǎo)向員工激勵(lì)與質(zhì)量意識(shí)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)督可靠度目標(biāo)更多地方體現(xiàn)精實(shí)生產(chǎn)之精神DNV - June 1999與QS-9000之不同點(diǎn)ISO9001：2000架構(gòu)及過(guò)程方顧客導(dǎo)向過(guò)程方法之顧客導(dǎo)向Organization顧 客顧 客OrganizationDNV - June 1999顧客導(dǎo)向過(guò)程方法之顧客導(dǎo)向Organization顧 客顧顧客導(dǎo)向流程顧客拿到報(bào)價(jià)單顧客要求報(bào)價(jià)DNV - June 1999顧客導(dǎo)向流程

22、顧客拿到DNV - June 1999小組COP練習(xí)請(qǐng)列出一家修車廠會(huì)有哪些顧客導(dǎo)向流程？DNV - June 1999小組COP練習(xí)請(qǐng)列出一家修車廠會(huì)有哪些顧客導(dǎo)向流程？DNV Different Types of Processes不同類型的過(guò)程Key Processes 關(guān)鍵過(guò)程Support Processes 支持性過(guò)程Management Processes管理過(guò)程DNV - June 1999Different Types of Processes不Key Processes 關(guān)鍵過(guò)程Any process which directly relates to an interfa

23、ce between an organization and its 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DNV - June 1999Key Processes 關(guān)鍵過(guò)程Any proSupport Processes支持性過(guò)程Each Key Process will be sup

24、plemented 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DNV - June 1999Support Processes支持性過(guò)程Each KeyManagement Processes管

25、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DNV - June 1999Management Processes管理過(guò)程May be流程型態(tài)Support ProcessesManagement Proce

26、ssesCore ProcessesDNV - June 1999流程型態(tài)Support ProcessesManagemen流程型態(tài)之范例Quality Maintenance Information Assurance ManagementDesignPurchasingServiceProductionPlanningDistribution Personnel Management Finance Planning by Objectives PlanningProductionDNV - June 1999流程型態(tài)之范例Quality Maintenance小組“過(guò)程鑒別”練習(xí)請(qǐng)列出

27、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DNV - June 1999小組“過(guò)程鑒別”練習(xí)請(qǐng)列出貴公司質(zhì)量管理體系之過(guò)程，并標(biāo)示其以流程為基礎(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)DNV - June 1999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)資流程解析顧客導(dǎo)向流程CustomerOrientedProcess管理流程ManagementProcess支持流程Support ProcessDNV - June 1999流程解析顧客導(dǎo)向流程管理流程支持流程Sup

28、port Proc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)DNV - June 1999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ISO/TS16949第4章通則：在TS16949體系，僅可排除7.3設(shè)計(jì)控制制程設(shè)計(jì)不得排除有關(guān)TS16949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4.1.1(一般要求-補(bǔ)充)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之產(chǎn)品的責(zé)任

29、DNV - June 1999ISO/TS16949第4章通則：DNV - June 19ISO/TS16949第4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 produc

30、tion?OJT?obsolete product quarantined in warehouse?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DNV - June 1999ISO/TS16949第4章建立書(shū)面程序之需求將于各章節(jié)規(guī)定何謂過(guò)程方法？Process 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)DNV - June 1999何謂過(guò)程方法？Process ApproachWith wh過(guò)程方法演練Quota

31、tion 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,Engineering,Bank,Accountant,HR,QA,Legislation exper

32、t,Financial,CustomerWhat result:Response cycle,error rate,Conversion rate with good profit,Quotation caseDNV - June 1999過(guò)程方法演練Quotation process:DNV - 小組“過(guò)程方法”練習(xí)請(qǐng)以過(guò)程方法分析車廠安全氣囊設(shè)計(jì)過(guò)程DNV - June 1999小組“過(guò)程方法”練習(xí)請(qǐng)以過(guò)程方法分析車廠安全氣囊設(shè)計(jì)過(guò)程DN過(guò)程方法演練Process:Air conditioning systemInput:Customer requirement,Regulation,Bu

33、siness plan,Bench market(price),FMEA,Aimed market climate,Requirements from counterparts,Department/product target.Output:D-FMEA,Engineering Drawings,Test Spec,Consistency concerns with counterparts,Guidance for maintainability.With what:Competent human resource,DFM/DFA data,CAD,Testing facility,Pro

34、totype,Previous experience(TGW,TGR),Timing chart,DOE,Design skils,SPC tech,Error proofing,Problem solving tech.DNV - June 1999過(guò)程方法演練Process:Air conditioning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

35、,Service,Sales,Government expert, Doc controller,Lab,Other design teams,Production,Development,Tooling,Equipment.What result:Lead time,Product cost,Design cost,reliability,Durability,Maintainability,ppm,First pass rate,Error on spec.DNV - June 1999過(guò)程方法演練How:Design control proce過(guò)程之量度指標(biāo)（1）Quotation:Re

36、ply time,error rate.Sales:Quotation turn over,quotation case,sales volume,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.Producti

37、on:Production efficiency,poor quality cost,Kaizen cases,OJT achievement,CpkDNV - June 1999過(guò)程之量度指標(biāo)（1）Quotation:Reply time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 evalu

38、ation,Human error cases in 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.DNV - June 1999過(guò)程之量度指標(biāo)（2）Quality Assurance:Cu過(guò)程之量

39、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.Maintenance:OEE,machine down time

40、.Measuring device:%R&R target.Shipping:On-time delivery,premium freight.DNV - June 1999過(guò)程之量度指標(biāo)（3）Purchasing:Supplier ISO/TS16949第5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 measurement for each process,monitor these measurement,check performance

41、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)DNV - June 1999ISO/TS16949第5章5.1.1(過(guò)程效率)最高管理者ISO/TS16949第5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

42、)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 production 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)DNV - June 1999ISO

43、/TS16949第5章(質(zhì)量目標(biāo)-補(bǔ)充)ISO/TS16949第5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（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 includ

44、e summary result of APQP as an input)(p.s.customer focus 5.2)(p.s.why discuss internal audit&preventive action?)(p.s.monthly QA meeting can be a M-review?)(p.s.SMD design & lot-out)DNV - June 1999ISO/TS16949第5章5.6管理評(píng)審：DNV - Ju管理評(píng)審補(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

45、何評(píng)估組織是否有落實(shí)顧客導(dǎo)向流程？DNV - June 1999管理評(píng)審補(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ISO/TS16949 第6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。

46、從事特定工作的人員的資格，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 ?)DNV - June 1999ISO/TS16949 第6章(產(chǎn)品設(shè)計(jì)技能)ISO/TS16949 第6章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

47、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 hi

48、gh 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 product

49、ion leader write number on ground)DNV - June 1999ISO/TS16949 第6章OJT對(duì)所有影響OJT-Competence Map多功能訓(xùn)練表：I：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作業(yè)#4作業(yè)#5作業(yè)#6作業(yè)員AndyILULOO作業(yè)員BenOOLUUO作業(yè)員JoeIILILUDNV - June 1999OJT-Competence Map作業(yè) #1作業(yè)#2作ISO/TS16949 第6章 (員工激勵(lì)和授權(quán))組織必須具有衡量過(guò)程，衡量員工是否意識(shí)到他們的活動(dòng)與如何達(dá)到質(zhì)量目標(biāo)所做貢獻(xiàn)之間的關(guān)系和重要性（p

50、.s.This is to measure the extent of employees are motivated.) (p.s.employee satisfaction survey?sensitive in some companies,annual interview,CAP due to human error,CI cases,in a state of order,employee know their quality objectives,s/c item aware,achievement in performance,absenteeism,job-off rate.)

51、DNV - June 1999ISO/TS16949 第6章 (員工激勵(lì)和授ISO/TS16949 第6章6.3.1.工廠、設(shè)施和設(shè)備策劃和效益須使用多方論證的方法工廠的布局應(yīng)盡量減少材料的轉(zhuǎn)移和搬運(yùn),便于材料的同步流動(dòng),并優(yōu)化對(duì)場(chǎng)地空間的增值使用(p.s. APQP layout review)制定和采用評(píng)價(jià)和監(jiān)視現(xiàn)有運(yùn)作有效性的方法(可考量以下因素:總體工作計(jì)劃,適當(dāng)?shù)淖詣?dòng)化,工效學(xué)與人的因素,生產(chǎn)線平衡,儲(chǔ)存及庫(kù)存水平,增值勞動(dòng))(p.s APQP,ECN,shall leave evidence, IE regular evaluation, turn over control, CI

52、, training,OJT,lean production spirit)DNV - June 1999ISO/TS16949 第6章6.3.1.工廠、設(shè)施和設(shè)備策ISO/TS16949 第6章6.3.2應(yīng)急計(jì)劃：包括市場(chǎng)退回（p.s.include utility interruption,labor shortage?OJT,main equipment breakdown?TPM?adjust production schedule?lead time control,all other factors,material shortage?alternative supplier ?6

53、.4.1(實(shí)現(xiàn)產(chǎn)品安全性的員工安全)組織應(yīng)體現(xiàn)對(duì)產(chǎn)品的安全性及最大程度降低對(duì)員工造成潛在風(fēng)險(xiǎn)方法的安全關(guān)注，特別是在設(shè)計(jì)和開(kāi)發(fā)過(guò)程、生產(chǎn)過(guò)程的實(shí)施中。其產(chǎn)品安全及方式須予以記載（p.s.SOP shall address,design output to id safety items,OJT,control plan,FMEA,it is not industrial safety and shall be focused on product safety,employee shall be aware of the product safety.)DNV - June 1999ISO/T

54、S16949 第6章6.3.2應(yīng)急計(jì)劃：包括市場(chǎng)退ISO/TS16949 第6章6.4.2生產(chǎn)現(xiàn)場(chǎng)的清潔供方應(yīng)保持生產(chǎn)現(xiàn)場(chǎng)處于適合所生產(chǎn)產(chǎn)品的有序.清潔的狀態(tài),并進(jìn)行適當(dāng)?shù)男拚? p.s. 5S is the typical,but not must 5S,this may effect the inspection status and visual identification for NG product?obsolete products in warehouse. P.S.First impression to survey supplierDNV - June 1999ISO/TS

55、16949 第6章6.4.2生產(chǎn)現(xiàn)場(chǎng)的清潔DNVISO/TS16949 第7章7.1.1產(chǎn)品實(shí)現(xiàn)策劃作為質(zhì)量計(jì)劃的組成部分應(yīng)包括顧客要求及其技術(shù)規(guī)范。（p.s.typical one is the control plan,C/P must be approved by Ford,higher/lower Cpk noted on C/P,Annual functional test can be included on C/P)DNV - June 1999ISO/TS16949 第7章7.1.1產(chǎn)品實(shí)現(xiàn)策劃作為質(zhì)量APQP(先期產(chǎn)品質(zhì)量規(guī)劃）之開(kāi)端輸入顧客的聲音（1）市場(chǎng)研究結(jié)果e.g.:

56、user survey,area survey(2)過(guò)去之檢驗(yàn)與質(zhì)量相關(guān)數(shù)據(jù)(3)小組之經(jīng)驗(yàn)業(yè)務(wù)計(jì)劃/市場(chǎng)策略產(chǎn)品/制程 標(biāo)竿策略4.1.5 level data產(chǎn)品/制程 設(shè)定e.g.:innovation,feature,process concept產(chǎn)品可靠度評(píng)估顧客輸入要求e.g.:spec,drawing,timingDNV - June 1999APQP(先期產(chǎn)品質(zhì)量規(guī)劃）之開(kāi)端輸入顧客的聲音DNV - ISO/TS16949 第7章7.1.2組織應(yīng)制定接收準(zhǔn)則.有些接收準(zhǔn)則要求顧客批準(zhǔn).計(jì)數(shù)數(shù)據(jù)抽樣計(jì)劃的接收準(zhǔn)則應(yīng)是零缺陷. (p.s.control plan shall add

57、ress this acceptance criteria when required by customers) (p.s.Ask customer representative) (p.s.If not zero defect in sampling plan,this may result in a major N/C,especially on FQC)DNV - June 1999ISO/TS16949 第7章7.1.2組織應(yīng)制定接收準(zhǔn)則.ISO/TS16949 第7章7.1.3組織應(yīng)確保顧客合同產(chǎn)品開(kāi)發(fā)項(xiàng)目和有關(guān)產(chǎn)品信息保密性(P.S.typical operation is to

58、 lock them in cabinet and control them,this requirement shall extend to protect customer patent?7.5.4 customer propertyDNV - June 1999ISO/TS16949 第7章7.1.3組織應(yīng)確保顧客合同產(chǎn)ISO/TS16949 第7章7.1.4組織應(yīng)有一個(gè)過(guò)程,以控制和處理影響產(chǎn)品實(shí)現(xiàn)的更改.評(píng)審所有更改的影響,包括任何供方引起的更改,并確定驗(yàn)證和確認(rèn)的程序(Re-PPAP),以確保符合顧客的要求.更改在執(zhí)行前必須被確認(rèn).(p.s.customer complaint o

59、r field failure?ECR?Timely review?Re-PPAP?ECN?maintain effective date?Introduce into production)和外形、性能、功能及耐久度相關(guān)之特性變更應(yīng)先與客戶共同商議,以確保影響能被適度評(píng)估,當(dāng)顧客要求時(shí)，額外的驗(yàn)證/識(shí)別要求，例如新產(chǎn)品說(shuō)明書(shū)的要求，必須被滿足P.s. engineering changeDNV - June 1999ISO/TS16949 第7章7.1.4組織應(yīng)有一個(gè)過(guò)程,以ISO/TS16949 第7章組織必須在特殊特性的選擇、文件化和控制方面證明遵守與顧客要求相一致放棄7.2.2中要求的

60、正式評(píng)審必須得到顧客授權(quán)(網(wǎng)絡(luò)下單)進(jìn)行合約評(píng)審時(shí),組織須研究、確認(rèn)并文件化該產(chǎn)品的制造可行性，包括風(fēng)險(xiǎn)分析.(p.s.risk analysis includes RPN of FMEA,Cpk,PPM,yielding trendetc and shall use multidisciplinary approach to make this decision)組織須有按顧客規(guī)定的格式傳遞必要的信息和資料的能力(e.g.CAD/CAE data,electronic data exchange,ASN,electronic communication for order receiving