ISO-TS16949培训教材(-134张)课件.ppt

QualitySatisfy,ISO/TS16949:2002课程,DNV - June 1999,1,ISO/TS16949:2002课程DNV - June,ISO/TS16949课程,学员自我介绍包括:姓名公司及产品在公司负责之工作对本课程之期望,DNV - June 1999,ISO/TS16949课程学员自我介绍包括:DNV - Ju,课堂要求,欢迎阁下参加本次课程，本课程将为您打下一个良好的基础，提高您的能力和水平.请注意以下的几点：1、手提电话传呼机 上课期间请将您的手提电话 和 传呼机开为振动或关闭.2、吸烟 在课堂内请不要吸烟.3、其它 课期间请不要大声喧哗, 举手提问, 不要随意走动.,DNV - June 1999,课堂要求DNV - June 1999,引 言,一个公司的质量问题- 94%归咎于体系或管理原因 6%归咎于偶发性原因,-戴明博士,DNV - June 1999,引 言 -戴明博士DNV - Ju,ISO/TS 16949:2002 ISO 9001:2000在汽车生产和相关服务件组织应用的特殊要求,ISO/TS 16949：2002随著汽车产业日渐国际化，单一且可以被所有汽车制造业者接受的质量管理系统愈显重要。ISO/TS 16949：2002的目标就是创造一个整合现有汽车业质量要求的管理系统。通过 ISO/TS 16949：2002将可使厂商免去多重验证的麻烦。ISO/TS 16949：2002是国际汽车推动小组 (International Automotive Task Force ,IATF, www.iaob.org) 根据ISO 9001：2000对汽车产业供应商所草拟的特定质量系统要求。本标准的版权所有归意大利ANFIA、法国CFA/FIEV、德国VDA以及美国的戴姆勒克莱斯勒、福特与通用等汽车厂所持有。ISO/TS 16949：2002为一国际标准，但其目的与QS 9000和VDA6.1等类似。,DNV - June 1999,ISO/TS 16949:2002 ISO 9001:20,从1996年起，IATF (International Automotive Task Force) 国际汽车工业行动小组开始着手协调汽车行业的质量体系要求， 1999年发布了ISO/TS 16949第一版，供汽车行业试行，并搜集使用中的信息和经验。经过三年的试用，并在各国汽车组织的积极推动下，IATF成员组织共同对ISO/TS 16949:1999进行了修订，并提交ISO组织批准和出版。第二版ISO/TS 16949:2002于2002年3月1日发布。ISO/TS 16949:2002是基于ISO 9001:2000, AVSQ（意大利）, EAQF（法国）, QS-9000（美国）, VDA 6.1（德国）而制定的，ISO/TS 16949:2002 与顾客特定要求一起构成为汽车供应链的质量体系要求。,一.IATF与ISO/TS 16949的产生,DNV - June 1999,从1996年起，IATF (International Au,二.ISO/TS16949是什么?,汽车业之工业标准由IATF、JAMA及ISO/TC 176支持所制定各地之监督机构:ANFIA(Italy)，IAOB （USA）,FIEV/CCFA (France),SMMT(UK), （VDA-QMC(Germany).整合ISO9001：2000之要求于2002-Mar-1发新版以配合ISO9001：2000架构条文将涵盖QS-9000、EAQF94、AVSQ94及 VDA6.1等各国汽车工业标准（非百分之百涵盖）,DNV - June 1999,二.ISO/TS16949是什么?DNV - June 19,ISO/TS16949是什么?,汽车制造厂亦可认证TS16949QS-9000将于2006-12-15失效，届时许多公司将无法转成TS16949产品未交入汽车供应链，汽车顾客未要求TS16949之工厂，After Market工厂皆不能认证TS16949（eligibility)AVSQ及EAQF将于2003-12-15失效将协调各国汽车工业标准和欧洲ISO GROUP及美国QS-9000而成为全球汽车工业之共同标准Ford，GM，Daimler Chrysler，BMW，Fiat，PSA Peugeot-Citroen，Renault SA and Volkswagen 已支持TS16949,DNV - June 1999,ISO/TS16949是什么?DNV - June 1999,三. Benefit of ISO/TS16949,Provide additional 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 efficiency6.Common language to improve understanding of quality requirements7.Improved product and process quality,DNV - June 1999,三. Benefit of ISO/TS16949DNV -,实施ISO/TS 16949:2002可带来以下好处：,ISO/TS 16949:2002注册要求,为供应链中的供应商/分承包商的持续改进和一致性提供了共通的质量管理体系方法减少为满足不同客户的要求而进行的第三方重复认证,提高产品质量和过程质量增强全球采购的信心有助于重新选定供货源以提高质量,全球的汽车制造商们已纷纷制订了注册计划要求,DNV - June 1999,实施ISO/TS 16949:2002可带来以下好处：ISO,四.ISO/TS16949相关标准,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 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/IEC17025:1999,General requirements for the competence of testing and calibration laboratories,DNV - June 1999,四.ISO/TS16949相关标准ISO/TS16949Qu,五.OEM厂对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, 2004-12-15)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/QS9000Nissan,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 certified,DNV - June 1999,五.OEM厂对TS16949之要求Daimler Chrys,六.ISO/TS 16949:2002 标准的沿革Reduced expenditure for a supplier with a QS9000 and VDA6.1-certificates,DNV - June 1999,六.ISO/TS 16949:2002 标准的沿革Redu,ISO/TS 16949:2002 标准的沿革,DNV - June 1999,SMMT (GB)BS 5750ISO 9000QS-900,七.ISO/TS16949的目标,强调缺失预防减少变异及浪费持续改进,DNV - June 1999,七.ISO/TS16949的目标强调缺失预防DNV - Ju,八.ISO/TS16949架构,More Specific,DNV - June 1999,八.ISO/TS16949架构Fundamental（ISO,九.谁可以执行TS16949之评审及发证,IATF所认可的认证机构，全球共48家，可在www.iaob.org上网查询QS-9000证书全球共发出22000张（500 in PRC,500 in Taiwan),TS16949：99证书为1700张（most in Europe）IATF严格限制新的认可机构，除非有人被除权否则难以进入此认可的认证机构名单BSI、DNV、TUN、BVQI、UL、Lloyds、SGS、Intertek、Entelaetc皆有资格发证,DNV - June 1999,九.谁可以执行TS16949之评审及发证IATF所认可的认证,十.ISO/TS16949提出的发现,主要缺点：（1）体系崩溃（2）丧失对制程的控制能力（3）将不合格品送交顾客次要缺点改进机会审核结论无主要或次要缺点：建议发证任何缺点：须提供书面纠正预防报告或进行跟进评审，审核通过才宣布建议发证。,DNV - June 1999,十.ISO/TS16949提出的发现主要缺点：（1）体系崩溃,十.ISO/TS16949之评审流程,符合Eligibility Requirement之工厂12个月之TS16949/QS-9000/VDA体系绩效记录至少一次之管理评审及内部审核，并确认体系之绩效与效率可接受提出申请？报价？召集评审小组？文件评审（须为现场评审，正审3个月前）？预评（可选择）？建立评审计划？现场评审？提出评审报告？缺失改进？评审小组确认？总部否决权审核？发出证书,DNV - June 1999,十.ISO/TS16949之评审流程符合Eligibilit,汽车业之特点,汽车零件80%之质量问题及70%之成本低减取决于设计与开发汽车制造厂（OEM）80%之问题为一阶供货商（Tier-1 supplier）所造成，一阶供货商80%之问题为二阶供货商（Tier-2 supplier）所造成开发期越来越短（18 months）？共享底盘，车厂合并,DNV - June 1999,汽车业之特点汽车零件80%之质量问题及70%之成本低减取决于,ISO/TS16949条文说明,ISO9001：2000之条文不在此描述下标字者为TS16949特有要求不再使用“Should”字眼，所有要求皆为“Shall”之强制要求文件化程序之要求包括训练,DNV - June 1999,ISO/TS16949条文说明DNV - June 1999,与QS-9000之不同点,ISO9001：2000架构及过程方法（process approach）更强调顾客导向员工激励与质量意识目标成本，降低成本之要求提升供货商制程绩效之监督可靠度目标更多地方体现精实生产之精神,DNV - June 1999,与QS-9000之不同点ISO9001：2000架构及过程方,顾客导向,过程方法之顾客导向,Organization,顾 客,顾 客,Organization,DNV - June 1999,顾客导向过程方法之顾客导向Organization顾 客顾,顾客导向流程,顾客拿到报价单,顾客要求报价,DNV - June 1999,顾客导向流程顾客拿到DNV - June 1999,小组COP练习,请列出一家修车厂会有哪些顾客导向流程？,DNV - June 1999,小组COP练习请列出一家修车厂会有哪些顾客导向流程？DNV,Different Types of Processes不同类型的过程,Key Processes 关键过程Support Processes 支持性过程Management Processes管理过程,DNV - June 1999,Different Types of Processes不,Key Processes 关键过程,Any process which directly relates to an interface between an organization and its customer 任何与组织及其顾客的接口直接相关的过程Critical to the achievement of Customer Satisfaction 实现顾客满意的过程Involves an input from the customer and an output to the customer 与从顾客的输入到对顾客的输出有关的过程,DNV - June 1999,Key Processes 关键过程Any pro,Support Processes支持性过程,Each Key Process will be supplemented by one or more support processes 每一个关键过程都会有一个或多个支持过程来补充Support processes would generally have internal customers and suppliers 支持性过程一般都有内部的顾客和供方Examples of support processes could be: 支持性过程举例： Training培训 Document Control文件控制,DNV - June 1999,Support Processes支持性过程Each Key,Management Processes管理过程,May be Support Processes 可以是支持性过程Are generally processes which manage the organisation or its quality 一般是对组织或其质量体系进行管理的过程Examples of management processes could be: 管理过程举例: Business Pianning经营计划 Management Revies管理评审,DNV - June 1999,Management Processes管理过程May be,流程型态,Support Processes,Management Processes,Core Processes,DNV - June 1999,流程型态Support ProcessesManagemen,流程型态之范例,Quality Maintenance Information Assurance Management,Design,Purchasing,Service,ProductionPlanning,Distribution,Personnel Management Finance Planning by Objectives Planning,Production,DNV - June 1999,流程型态之范例Quality Maintenance,小组“过程鉴别”练习,请列出贵公司质量管理体系之过程，并标示其为关键，支持或管理过程,DNV - June 1999,小组“过程鉴别”练习请列出贵公司质量管理体系之过程，并标示其,以流程为基础之质量管理体系模式,质量管理体系持续改进,管理职责,资源管理,产品实现,测量、分析与改进,产 品,顾客,要求,顾客,满意度,信息,输入,输出,信息,增值活动,增值活动,DNV - June 1999,以流程为基础之质量管理体系模式质量管理体系持续改进管理职责资,流程解析,顾客导向流程CustomerOrientedProcess,管理流程ManagementProcess,支持流程Support Process,DNV - June 1999,流程解析顾客导向流程管理流程支持流程Support Proc,以流程为基础之质量管理体系模式,质量管理体系持续改进,管理职责,资源管理,产品实现,测量、分析与改进,产 品,顾客,要求,顾客,满意度,信息,输入,输出,信息,增值活动,增值活动,DNV - June 1999,以流程为基础之质量管理体系模式质量管理体系持续改进管理职责资,ISO/TS16949第4章,通则：在TS16949体系，仅可排除7.3设计控制制程设计不得排除有关TS16949之运用，另可参考“IATF Guidance to ISO/TS16949:2002”TS16949亦可运用于协力厂商链中之所有工厂4.1.1(一般要求-补充)对于外包制程之控制的确保，外包不能免除组织提供符合顾客所有要求之产品的责任,DNV - June 1999,ISO/TS16949第4章通则：DNV - June 19,ISO/TS16949第4章,建立书面程序之需求将于各章节规定4.2.3.1(工程规范)组织必须建立过程以保证按照顾客要求的时间表及评审、发放和实施所有顾客的工程标准/规范及基于顾客要求时间进度的更改。应该尽快进行及时的评审，时间必须不能超过两个工作周。保存每项更改在生产中实施的日期的记录。包括对所有适当文件的更新（p.s ECN from customer,C/P action,field failure?timely review?Re-PPAP?update document?introduce in production?OJT?obsolete product quarantined in warehouse?p.s.在生产中实施的日期是指生产日期或台数,非变更发布日期4.2.4.1(记录保存)质量记录之保存期需符合法规及顾客要求,DNV - June 1999,ISO/TS16949第4章建立书面程序之需求将于各章节规定,何谓过程方法？,Process Approach,With what用哪些,With who跟谁做,Output输出,Process过程,How如何做,Input输入,What result量度方法/指标,DNV - June 1999,何谓过程方法？Process ApproachWith wh,过程方法演练,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,Engineering,Bank,Accountant,HR,QA,Legislation expert,Financial,CustomerWhat result:Response cycle,error rate,Conversion rate with good profit,Quotation case,DNV - June 1999,过程方法演练Quotation process:DNV -,小组“过程方法”练习,请以过程方法分析车厂安全气囊设计过程,DNV - June 1999,小组“过程方法”练习请以过程方法分析车厂安全气囊设计过程DN,过程方法演练,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,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.,DNV - June 1999,过程方法演练Process:Air conditioning,过程方法演练,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 result:Lead time,Product cost,Design cost,reliability,Durability,Maintainability,ppm,First pass rate,Error on spec.,DNV - June 1999,过程方法演练How:Design control proce,过程之量度指标（1）,Quotation:Reply 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.Production:Production efficiency,poor quality cost,Kaizen cases,OJT achievement,Cpk,DNV - June 1999,过程之量度指标（1）Quotation:Reply time,过程之量度指标（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 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,过程之量度指标（2）Quality Assurance:Cu,过程之量度指标（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.Measuring device:%R&R target.Shipping:On-time delivery,premium freight.,DNV - June 1999,过程之量度指标（3）Purchasing:Supplier,ISO/TS16949第5章,5.1.1(过程效率)最高管理者必须评审产品实现过程和支持过程，以确保产品实现的有效性和效率 （p.s Using process approach methodology to setup measurement 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.(质量方针)质量政策需提及质量体系之持续改进（ISO9001：2000 clause),DNV - June 1999,ISO/TS16949第5章5.1.1(过程效率)最高管理者,ISO/TS16949第5章,5.4.1.1(质量目标-补充)业务计划须确定质量目标，以开展质量方针（note:address customer expectation and in timely frame)5.5.1.1(质量责任)不符合规范要求的产品或过程，必须迅速通知给负有纠正措施职责和权限的管理者。负责产品质量的人员，为了纠正质量问题，必须有权停止生产。所有班次的生产操作，必须指定负责人员（p.s.All shifts audit,lead time control,record of C/P action,FMEA,reaction plan,lean production spirit)5.5.2.1(顾客代表)指定某一或多位人员来代表顾客，传递相关需求（P.S.To ask his understanding about OEM requirements,s/c definition),DNV - June 1999,ISO/TS16949第5章5.4.1.1(质量目标-补充),ISO/TS16949第5章,5.6管理评审：（1）市场退回及其对质量，安全及环保之冲击需列入讨论（2）需包含评审所有质量体系要素及其绩效（持续改进之依据）（3）需包含对质量目标之监视及质量不良成本之报告与分析（4）结论需予以记录，以证明以下之达成状况：（a）业务计划所定之质量目标（b）顾客满意度（p.s.poor quality cost?ice mountain?window lifter module,why need review impact in safety/environment?FMEA review?)(p.s.shall include 7.3.4.1 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 1999,ISO/TS16949第5章5.6管理评审：DNV - Ju,管理评审补充,为何不良质量成本要列入管理评审中做讨论？是否可用质量成本来取代?每月品管会议可不可以代替管理评审?为何市场退回要列入管理评审中做讨论？如何评估组织是否有落实顾客导向流程？,DNV - June 1999,管理评审补充为何不良质量成本要列入管理评审中做讨论？是否可,ISO/TS16949 第6章,6.2.2.1(产品设计技能)必须确保负有产品设计职责的人员有能力达到设计要求并熟练地掌握适用的工具和技术，组织须识别适用的工具和技术（p.s tools:QFD DOE,FMEA,CAD/CAEetc,D-FMEA weak in most of companies,Technique:knowledge and experience in product.)6.2.2.2(培训)必须建立并保持形成文件的程序，识别培训需求，所有从事对产品质量有影响的工作的人员具有能力。从事特定工作的人员的资格，必须进行考核。（设计人员、改进小组、实验室人员、色差检验员、内审人员等）。并且这种考核应对顾客要求的满足特别加以关注（p.s.ask customer representative,APQP input,contract review,typical requirement of customer:the application of digitized, math-based data ?),DNV - June 1999,ISO/TS16949 第6章6.2.2.1(产品设计技能),ISO/TS16949 第6章,6.2.2.3OJT对所有影响产品质量的工作，组织必须对新到职或调整工作的工作人员提供适当的在职培训，包括合同工和代理工作人员。必须告知其工作影响质量的人员不符合质量标准对顾客造成的后果（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.)6.2.2.4(员工激励和授权)组织必须建立一个促进员工实现质量目标、进行持续改进和建立促进创新的环境的过程。该过程必须包括促进整个组织对质量和技术的认知。（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),DNV - June 1999,ISO/TS16949 第6章6.2.2.3OJT对所有影响,OJT-Competence Map,多功能训练表：I：未熟悉，L：可胜任，U：纯熟，O：可教导他人,DNV - June 1999,OJT-Competence Map作业 #1作业#2作,ISO/TS16949 第6章,6.2.2.4 (员工激励和授权)组织必须具有衡量过程，衡量员工是否意识到他们的活动与如何达到质量目标所做贡献之间的关系和重要性（p.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.),DNV - June 1999,ISO/TS16949 第6章6.2.2.4 (员工激励和授,ISO/TS16949 第6章,6.3.1.工厂、设施和设备策划和效益须使用多方论证的方法工厂的布局应尽量减少材料的转移和搬运,便于材料的同步流动,并优化对场地空间的增值使用(p.s. APQP layou