TS16949 Training

单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,*,ISO/TS16949:2002 Training,Prepared By,Chriss Zheng,Site QA,Jul. 2005,质量管理体系汽车生产和相关维修零件组织应用ISO9001：2000的特别要求,1,Agenda,History,Quality System Basic Knowledge,TS16949 Additional Requirements,2,ISO/TS 16949,:2002,BS 5750,ISO 9000,:1994,VDA6,QS-9000,AVSQ,EAQF,ISO/TS 16949,:1999,ISO 9001:2000,ISO/TS 16949: 2002 Roadmap,3,ISO/TS 16949:2002,Finalization,ISO/TS 16949:2002,是由下列单位起草,:,国际汽车行动小组 (,IATF),日本车辆制造者协会(,JAMA),ISO/TC 176,所支持,取代初版,1999,ISO/TS 16949:2002,整合,所有,ISO9001:2000,之要求,4,Membership,O,f,T,he IATF,Registrar scheme administered by IATF.,Certification delegated to National Trade associations;,5,QS9000,Difference Between ISO9001/TL9000/QS9000/TS16949,ISO/TS 16949,TL9000:R3.0,ISO9001:2000,6,ISO/TS 16949:2002,Goal,Continual improvement,持续改进,Emphasizing defect prevention,强调缺陷预防,The reduction of variation and waste,减少变差和浪费,Including customer specific requirements,7,ISO/TS 16949:2002 OEM Requirement,8,Eligibility for ISO/TS16949:2002,任何汽车供应链内组织均符合本规范所指具认证资格,任何由发动机驱动之车辆均可考量视为汽车业,汽车相关之零件,适用于生产或服务零件制造场所,场所的定义为增值制造流程产生的地点,制造的定义为制作生产原料,零件或组装,或热处理,涂装与电镀服务,9,Continual,I,mprovement,O,f,T,he,Q,uality,M,anagement,S,ystem,Customer,Customer,Requirements,Satisfaction,Management,responsibility,Resource,Management,Measurement,analysis and,improvement,Product,realization,Product,output,input,Q,uality,M,anagement,P,rocess,M,odel,10,输入,输出,活动,（加资源）,Basic Process Model,11,Output,Input,Resources,(Equipment/ Capital),Resources,(People),How,如何做,What result,量度方法,能力/技能/资格,机器/设备/装置,方法/程序/指导书/技术,测量/评估/绩效/指标,Process Model,Analysis,龟形图,Process,12,Process And Process Approach,Customer Oriented Processes,客戶,导向过程,Support,Oriented,Processes,支,持性导向过,程,Management,Oriented,Processes,管理导向过程,13,Market Analysis/Customer Requirement,Tender/Bid,Order/Request,Product and Process Design,Product and Process Verification/Validation,Product Manufacturing,Delivery,Payment,Warranty/Service,Post Sales/Customer Feedback,Customer Oriented Processes,组织,活动1,活动2,活动3,支援过程,输入,输出,客户,In,Out,1,2,3,14,Out,In,7,6,5,4,3,2,8,1,In,In,In,In,In,In,In,Out,Out,Out,Out,Out,Out,Out,客戶要求,报价,客户拿到,报价单,Customer Oriented Processes,章鱼图,15,Management,review,Customer focus,Quality policy,and objectives monitor,Quality management system planning,Management Oriented Processes,16,Certificate Process,创建体系并实施至少,12个月确认所有客户,要求已实施,向,IATF,认可之认证,单位提出申请,全球只有48家被认可,到厂进行文件审查,三个月内进行正式评鉴,(事先提报到,IATF),文审后三个月内,需正式评鉴,评估纠正措施,核发具,IATF,序号,之认证证书,依续审规定进行,延期不得超过一个月,第三年为重新评鉴,重新评估证书再发,17,Customer Focus,以客户为关注焦点,Quality Management System Principles,Leadership,领导作用,Involvement Of People,全员参与,Process Approach,过程方法,System Approach To Management,系统化管理,Factual Approach To Decision Making,基于事实的决策方法,Mutually Beneficial Supplier Relationships,与供方互利的关系,Continual Improvement,持续改进,18,Customer Focus,以客户为关注焦点,Organizations depend on their customers and therefore should understand,current and future customer needs, should meet customer requirements and,strive to exceed customer expectations。,组织依赖于他们的客户，因此应该了解客户当前和未来的需求，应该满足客,户的要求，并应该致力于超越客户的期望。,Quality Management System Principles,19,Leadership,领导作用,Leaders establish unity of purpose and direction of the organization. They,should create and maintain the internal environment in which people can,become fully involved in achieving the organizations objective.,领导者建立其组织的方向和统一的目标，他们应该创造并维护内部环境以使,组织中的人们能充分参与到实现组织的目标的活动中去,。,Quality Management System Principles,20,Involvement of People,全员参与,People at all levels are the essence of an organization and their full,involvement enables their abilities to be used for the organizations benefit.,组织中所有层次的员工是组织的基本，他们的充分参与能使他们的才能被用,于使组织的获利。,Quality Management System Principles,21,Process Approach,过程方法,A desired result is achieved more efficiently when activities and related,resources are managed as a process.,当活动和有关资源被作为一个过程管理起来时，期望的结果能被更有效的实现。,Quality Management System Principles,22,System Approach To Management,系统化管理,Identifying, understanding and managing interrelated processes as a system,contributes to the organizations effectiveness and efficiency in achieving its,objectives.,作为一个系统识别、了解并管理相互关联的过程，致力于组织的效益和效率,以实现组织的目标。,Quality Management System Principles,23,Continual Improvement,持续改进,Continual improvement of the organizations overall performance should be,a permanent objective of the organization.,持续改进组织的各个方面的表现应该是组织永恒的目标。,Quality Management System Principles,24,Factual Approach To Decision Making,基于事实的决策方法,Effective decisions are based on the analysis of data and information.,有效的决策应基于对数据和信息的分析的基础上。,Quality Management System Principles,25,Mutually Beneficial Supplier Relationships,与供方互利的关系,An organization and its suppliers are interdependent and a mutually beneficial,relationship enhances the ability of both to create value.,组织及其供应商之间应是相互依赖的，并且互利的关系能提高两者创造价值的,能力。,Quality Management System Principles,26,ISO/TS16949:2002,Document Procedure,七个需要文档化的程序,：,文档管制(4.2.3),记录管制(4.2.4),培训(6.2.2.2),内部稽核(8.2.2),不合格品控制(8.3),纠正措施(8.5.2),预防措施(8.5.3),27,七个必需的程序，但未必文档化,：,员工激励与强化(6.2.2.4),变更管制(7.1.4),来料品质(7.4.3.1),服务信息的反馈(7.5.1.7),监控与测量装置的控制(7.6),内部实验室(7.6.3.1),持续改进(8.5.1.1),ISO/TS16949:2002,Document Procedure,28,4Quality Management System,29,Ensuring control over,outsourced processes,shall,not absolve the,organization of the responsibility of conformity to all customer,requirements.,确保对,外包过程,的控制不能免除组织符合所有顾客要求的责任。,NOTE: See also 7.4.1,Purchasing process,7.4.1.3,Customer-approved sources,4.1.1 General Requirements Supplemental,总要求补充,30,The organization,shall,have a process to assure the timely review, distribution,and implementation of all customer engineering standards/ specifications and,changes based on customer-required schedule. Timely review should be as,soon as possible, and shall not exceed,two working weeks.,The organization,shall,maintain a,record,of the date on which each change is,implemented in production.,Implementation shall include updated documents.,组织应有一个过程以便确保根据顾客要求的日程及时评审、发放和实施所有顾客,工程标准/规范及更改。及时评审应尽快并且不超过,两个工作周,。,组织应保存每项更改在生产中实施日期的,记录,。实施应包括文件的更新。,注：当设计记录引用这些规范或这些规范影响生产件批准过程的文件,（例如Control Plan, FMEA等）时，这些标准、规范的更改要求对客户的,生产件批准记录进行更新。,4.2.3.1Engineering Specifications,工程规范,31,注1：上述处置包括,处理,；,注2：记录也包括,顾客规定,的记录。,4.2.4 Control Of Records,记录控制,32,The control of records,shall,satisfy,regulatory and customer requirement,.,记录的控制,应,满足,法律和顾客要求,。,4.2.4.1 Records Retention,记录保存,33,5Management responsibility,34,Top management,shall,review the product realization processes and the,support processes to assure the,effectiveness and efficiency,.,最高管理者,应,评审产品实现过程和其支持过程以确保它们的,有效性和效率,。,5.1.1 Process Efficiency,过程有效性,35,Top management shall define quality objectives and,measurements,that,shall,be included in the,business plan,and used to deploy the quality policy.,最高管理者,应,规定质量目标和,测量方法,并应被包括在,经营计划,中,并用于展开,质量方针.,注: 质量目标,应,表述顾客期望并且在,规定时间阶段,内可完成.,5.4.1.1 Quality Objectives Supplemental,质量目标 补充,36,Managers with responsibility and authority for corrective action,shall,be,promptly informed,of products or processes which do not conform to,requirements.,Personnel responsible for product quality,shall,have the authority to,stop,production,to correct quality problems.,Production operations across,all shifts,shall,be staffed with personnel in,charge of, or delegated responsibility for, ensuring product quality.,应,迅速,把不符合规定要求的产品或过程,通报,给负责纠正措施的管理者。,负责产品质量的人员,应,有权停止生产以纠正质量问题。,跨,所有班次,的生产操作,应,配备人员负责或指派职责，以确保产品质量。,5.5.1.1 Responsibility For Quality,质量职责,37,Top management,shall,designate personnel with responsibility and authority,to ensure the customer requirements are addressed.,This includes selection of special characteristics, setting quality objectives,and related training, corrective and preventive actions, product design and,development.,最高管理者,应,指派人员有职责和权限确保顾客要求被阐述。,这包括：选择特殊特性、确定质量目标和相关培训、纠正和预防措施，,产品设计和开发。,SLR Customer representative is PM,5.5.2.1 Customer Representative,客户代表,38,These reviews,shall,include all requirements of the quality management,system and its performance trends as an essential part of the continual,improvement process.,Part of the management review,shall,be the monitoring of,quality objectives,and the regular reporting and evaluation of the,cost of poor quality.,These results,shall,be recorded to provide, as a minimum, evidence of the,achievement of :the business plan quality objectives,customer satisfaction with product supplied.,作为持续改进过程的一个重要部分,这些评审,应,包括质量管理体系的所有要求及,其业绩的趋势。,管理评审的部分内容,应,是,质量目标的监视和不良质量成本,（见8.4.1和8.5.1）,的定期报告和评估。,这些管理评审的结果,应,被记录以便提供达到以下结果最基本的证据:,-在经营计划中规定的质量目标,-顾客对提供产品的满意程度.,5.6.1.1 Quality Management System Performance,质量管理体系业绩,39,Input to management review,shall,include an analysis of actual and potential,field-failures,impact on quality, safety, or the environment.,管理评审输入应包括实际和潜在,外部,失效,以及它们对质量、安全或环境的影,响的分析。,5.6.2.1 Review Input Supplemental,评审输入-补充,40,6 Resource Management,41,The organization,shall,ensure that,personnel with product design,responsibility are competent to achieve design requirements and are skilled in,applicable tools and techniques.,Applicable tools and techniques,shall,be identified by the organization.,组织,应,确保负有产品设计职责的人员有能力达到设计要求并且熟练掌握适用的,工具和技术。,适用的工具和技术,应,被组织识别。,6.2.2.1Product Design Skills,产品设计技能,42,The organization,shall,establish and maintain,documented procedures,for identifying training needs and achieving competence of all,personnel performing specific assigned tasks shall be qualified, as,required with particular attention to the satisfaction of customer,requirements.,组织,应,建立并保持,形成文件的程序,识别培训需求和达到所有从事影响产品质,量工作的人员能力。从事特殊指派任务的人员应被资格考核，如要求对顾客,要求的满意程度予以特别关注。,注1：此要求适用于组织所有影响质量的,所有层次上的员工,。,注2：顾客规定要求的一个例子是数字化的,数学数据,的应用。,6.2.2.2Training,培训,43,The organization,shall,provide,on-the-job training,for personnel in any,new or modified job affecting product quality including contract or,agency personnel. Personnel whose work can affect quality,shall,be,informed about the consequences to the customer of non-conformity,to quality requirements.,组织,应,为包括合同工或代理在内的从事新的或更改的影响产品质量的工作的人,员提供,岗位培训,。对于,不符合质量要求对顾客造成的后果,应,通知,其工作影响质,量的人员。,6.2.2.3Training On The Job,岗位培训,44,The organization,shall,have a process to,motivate employees,to achieve,quality objectives, to make continual improvements, and to create an,environment to promote innovation. The process shall include the promotion,of quality and technological awareness throughout the whole organization.,The organization,shall,have a process to,measure,the extent to which its,personnel are,aware of,the relevance and importance of their,activities,and,how they,contribute,to the achievement of the quality objectives see 6.2.2 d).,组织,应,建立一个,激励员工,达到质量目标的过程，以进行持续改进并创建一个促,进革新的环境。过程应包括在整个组织内促进质量和技术意识。,组织,应,有一个过程以,测量,员工,认识,到所从事活动的,相关性和重要性的程度,，以,及如何,为实现质量目标做出贡献,（见6.2.2 d）。,6.2.2.4Employee Motivation And Empowerment,员工激励和授权,45,The organization,shall,use a,multidisciplinary approach,(see 7.3.1.1) for,developing plant, facility and equipment plans. Plant layouts shall optimize,material travel, handling and value-added use of floor space, and,shall,facilitate synchronous material flow. Methods,shall,be,developed and,implemented to evaluate and monitor,the effectiveness of existing,operations.,组织,应,采取,多方论证,的方法（见7.3.1.1）开发工厂、设施和设备计划。工厂的,布局应最大限度地减少材料的交转和搬运，便于材料的同步流动，以及最大限,度地使场地空间得到增值使用。,应,开发并实施评价和监视,现有操作和过程有效,性的方法。,注：这些要求应以“,精益生产,”原则和,质量管理体系,的有效性的联系为关注焦点。,6.3.1 Plant, Facility And Equipment Planning,工厂、设施和设备策划,46,The organization,shall,prepare,contingency plans,to satisfy customer,requirements in the event of an emergency such as utility interruptions,labour shortages, key equipment failure and field returns.,组织应制定,应急计划,以便在紧急情况(如供应中断、劳动力短缺，关键设备,故障和现场退货)下满足顾客需求。,6.3.2 Contingency Plans,应急计划,47,Product safety and means to minimize potential risks,to employees,shall,be addressed by the organization, especially in the design and development,process and in manufacturing process activities.,组织,应,阐述产品安全和最小化对员工的潜在风险的方法,，特别是在设计和开发,过程和在制造过程活动中。,6.4.1 Personnel Safety To Achieve Product Quality,与实现产品质量相关的人员安全,48,The organization,shall,maintain its premises in a state of order, cleanliness,and repair consistent with the product and manufacturing process needs.,组织,应,保持生产现场处于与产品和制造过程的需求相协调的有序、清洁和维护,的状态。,6.4.2 Cleanliness Of Premises,生产现场的清洁,49,7Product Realization,50,注:,有些顾客将项目管理或产品先期质量策划作为一种完成产品实现的方法。产品先期质量策划包含着,防错和持续改进的概念,，与找出错误不同，而且是基于,多方论证,的方法。,7.1 Planning Of Product Realization产品实现的策划,51,Customer requirements and references to its technical specifications,shall,be included in the planning of product realization as a component of the,quality plan.,作为质量计划的一部分，产品实现策划,应,包括,顾客要求和对其技术规范的引用,。,7.1.1Planning of product realization Supplemental 产品实现的策划补充,52,Acceptance criteria,shall,be defined by the organization and, where required,approved by the customer.,For,attribute data,sampling, the acceptance level shall be,zero defects,.,接受准则,应,由组织规定并且在要求时由顾客批准。,对于,计数型,数据的抽样，接受准则应是,零缺陷,（见8.2.3.1).,7.1.2 Acceptance Criteria接受准则,53,The organization,shall,ensure the confidentiality of,customer-contracted,products and projects under development, and related product information.,组织,应,确保,顾客合同,中在开发的产品和项目以及相关产品信息的保密性.,7.1.3 Confidentiality保密,54,7.1.4 Change Control更改控制,The organization,shall,have a process to control and react to changes that,impact,product realization,. The effects of any change, including those changes caused by any,supplier, shall be assessed, and verification and validation activities shall be defined, to,ensure compliance with customer requirements. Changes shall be validated before,implementation.,For proprietary designs, impact on form, fit and function (including performance and/or,durability) shall be reviewed with the customer so that all effects can be properly evaluated.,When required by the customer, additional verification/identification requirements, such as,those required for new product introduction, shall be met.,组织,应,有一个过程对影响产品实现的更改进行控制和反应。包括由任何供方引起的任何更改,的影响应进行评估。应规定更改的验证和确认活动以确保符合顾客要求。,更改应在实施之前,进行确认,。对有专利权的设计，影响形状、配合和功能（包括性能和/或耐久性）应会同顾,客进行评审，以便所有影响能被正确地评估。,当顾客要求时，应满足附加的验证/标识要求(如：引入新型号)。,注1：影响顾客要求的任何产品实现更改要求通知顾客并且,取得顾客同意,。,注2：以上要求适用于产品更改和制造过程更改。,55,7.2.1 Determination Of Requirements Related To The Product 与产品有关的要求的确定,NOTE 1: Post-delivery activities include any after-sales product service provided,as part of the customer contract or purchase order.,NOTE 2: This requirement includes recycling, environmental impact and,characteristics identified as a result of the organizations knowledge of the product,and manufacturing processes (see 7.3.2.3).,NOTE 3: Compliance to item c) includes all applicable government, safety and,environmental regulations, applied to acquisition, storage, handling, recycling,elimination or disposal of materials.,注1：交付后的活动包括顾客合同或采购定单中要求提供的任何售后产品服务。,注2：此要求包括回收再利用、环境影响以及由于组织对产品和制造过程的知识而,确定的特性（见7.3.2.3）。,注3：符合项目c)的要求包括所有适用的政府、安全和环境法规，适用于材料的,获得、储存、搬运、回收、销毁和处理。,56,7.2.1.1 Customer-Designated Special Characteristics顾客指定的特殊特性,The organization,shall,demonstrate conformity to customer requirements for,designation, documentation and control of,special characteristics,.,组织,应,证明符合顾客关于,特殊特性,的指定,、,文件化和控制的要求,。,57,7.2.2.1 Review Of Requirements Related To The Product Supplemental 相关产品要求的评审 补充,Waiving the requirement stated in 7.2.2 for a formal review (see note,),shall,require,customer authorization,.,7.2.2中规定的正式评审要求（见注）的免除,应,经,顾客授权,。,58,7.2.2.2 Organization Manufacturing Feasibility组织制造可行性,The organization,shall,investigate, confirm and document the manufacturing,feasibility of the proposed products in the contract review process, including,risk,analysis.,组织,应,在包括,风险分析,的合同评审过程中,，,调查、确认建议产品的制造可行性并,文件化,。,59,7.2.3.1 Customer Communication Supplemental 客户沟通补充,The organization,shall,have the ability to communicate necessary information,including data, in a,customer specified language and format,(e.g. computer-,aided design data, electronic data exchange).,组织,应,有能力按照,顾客规定的语言和格式沟通,包括数据的必要的信息（例如计算,机辅助设计数据、电子数据交换）。,60,7.3 Design And Development设计和开发,NOTE: The requirements of 7.3 include product and manufacturing process,design and development, and,focus on error prevention,rather than detection,.,注：7.3的要求包括产品和制造过程设计和开发,，应以,错误预防为关注焦点,而不是,探测,。,61,7.3.1.1 Multidisciplinary Approach 多方论证方式,The organization,shall,use a,multidisciplinary approach,to prepare for product,realization, including,.,development/finalization and monitoring of special characteristics,.,development and review of FMEAs, including actions to reduce potential risks,.,development and review of control plans.,NOTE: A multidisciplinary approach typically includes the organizations design,manufacturing, engineering, quality, production and other appropriate personnel.,组织,应,使用一个,多方论证,的方法去准备产品实现,包括,:,-开发/最终确定和监视特殊特性;,-开发和评审FMEAs,包括降低潜在风险的措施;,-开发和评审控制计划。,注:一个典型的多方论证的方法包括组织的设计、制造、工程、质量、生产和其他,适当人员。,62,7.3.2.2 Manufacturing Process Design Input制造过程设计输入,The organization,shall,identify, document and review the manufacturing process,design input requirements, including,.,product design output data,.,targets for productivity, process capability and cost,.,customers requirements, if any, and,.,experience from previous developments.,组织,应,确定,、,文件化和评审制造过程设计输入要求，包括,：,-产品设计输出数据；,-生产力、过程能力和成本指标；,-顾客要求（如果有），和,-以前开发的经验。,注：制造过程设计包括防错方法的使用，防错方法的使用程度和问题的重要性,相适应并和遇到的风险相称。,63,7.3.2.3 Special Characteristics特殊特性,The organization,shall,identify,special characteristics,see 7.3.3 d) and,.,include all special characteristics in the control plan,.,comply with customer-specified definitions and symbols,.,identify process control documents including drawings, FMEAs, control plans,and operator instructions with the customers special characteristic symbol or the,organizations equivalent symbol or notation to include those process steps that,affect special characteristics.,NOTE： Special characteristics can include,product characteristics,and,process parameters.,组织,应,确定,特殊特性,（见7.3.3 d）并：,-在控制计划中包含所有特殊特性;,-符合顾客规定的定义和符号；,-把顾客特殊特性符号或组织等效符号或记号标注在过程控制文件（包括图纸、,FMEAs、控制计划和操作者指导书）上，包括那些影响特殊特性的过程步骤,。,注,：,特殊特性包括,产品特性,和,过程参数,。,64,7.3.3.2 Manufacturing Process Design Output制造过程设计输出,The manufacturing process design output shall be expressed in terms that can be verified against,manufacturing process design input requirements and validated. The manufacturing process design,output shall include,.,specifications and drawings,.,manufacturing process flow chart/layout,.,manufacturing process FMEAs,.,control plan (see 7.5.1.1),.,work instructions,.,process approval acceptance criteria,.,data for quality, reliability, maintainability and measurability,.,results of error-proofing activities, as appropriate, and,.,methods of rapid detection and feedback of product/manufacturing process nonconformities.,制造过程设计输出应能根据制造过程设计输入要求验证和确认的形式表达。制造过程设计输出应包括：,-,规范和图纸；,-,制造过程流程图/场地平面布置图；,-制造过程FMEAs；,-控制计划（见7.5.1.1）；,-作业指导书；,-过程批准的接受准则；,-质量、可靠性、可维护性和可测量性数据；,-适当时，防错活动结果；,-产品/制造过程不符合的快速探测和反馈方法。,65,7.3.4 Design And Development Review 设计和开发评审,NOTE: These reviews are normally coordinated with the design phases and,include,manufacturing process design and development,.,注,：,这些评审通常结合设计阶段并包括,制造过程设计和开发,。,66,7.3.4.1 Monitoring监控,Measurements at specified stages of design and development,shall,be defined,analysed and reported with summary results as an,input to management,review,.,NOTE: These measurements include quality risks, costs, lead-times, critical,paths