ISO-TS16949trainingforlineleaderrev3

1、EEMS - CONFIDENTIALJenny / 2010ISO/TS16949 Basic TrainingEEMS - CONFIDENTIAL课程内容第一章: ISO/TS16949质量管理体系背景第二章: ISO/TS16949质量管理体系要求 * 条款4. 质量管理体系 * 条款6. 资源管理 * 条款7. 产品实现 * 条款8. 测量,分析和改进第三章: 质量管理体系过程方法的审核EEMS - CONFIDENTIAL第一章: ISO/TS16949质量管理体系背景EEMS - CONFIDENTIAL质量体系的趋势质量优秀模式如TQM, 6SIGMA行业特殊标准如汽车行业(T

2、S16949), 航空业(AS9100), 电信业(TL9000)等等基础质量体系模式如ISO9001更基础EEMS - CONFIDENTIALISO 9000质量管理体系标准 ISO 9000:2005 质量管理体系: 基础和术语 ISO 9001:2008 质量管理体系: 要求 ISO 9004:2009 - 质量管理体系:组织持续成功的管理 - 一种质量管理方法 ISO 19011:2002 质量和环境审核指南EEMS - CONFIDENTIALISO 9000 :2005以过程为导向鼓励组织: -分析顾客的要求 -规定过程, 以提供满足质量要求的产品 -保持这些过程受控股顾客满意帮

3、助组织增强顾客满意持续改进提供: -一个持续改进的框架 -信任, 证明组织能够持续满足顾客要求EEMS - CONFIDENTIAL以过程为基础的质量管理体系模式EEMS - CONFIDENTIALISO/TS16949 旨在成为国际汽车标准 与顾客特殊要求配套, 应用于汽车供应链 要求独立的第三方认证 第一版, 1999; 第二版, 2002; 第三版, 2009EEMS - CONFIDENTIALISO/TS16949:2009质量管理体系汽车生产和相关服务零件组织应用ISO9001:2008的特别要求国际汽车推动小组(IATF)和日本汽车制造商协会(JAMA)制定ISO/TC 176

4、 质量管理和质量保证技术委员会支持基于ISO9001(质量管理体系要求), ISO9004(质量管理体系业绩改进指南), AVSQ(意大利), EAQF(法国), QS-9000(美国)和VDA6.1(德国), 但并不替代这些要求, 取决于顾客的要求全球主要汽车制造商参与EEMS - CONFIDENTIALISO9001与ISO/TS16949的相互关系EEMS - CONFIDENTIAL第二章: ISO/TS16949质量管理体系要求EEMS - CONFIDENTIALISO9001:2008的内容(ISO/TS16949:2009)1. 范围2. 引用标准3. 术语(供方 组织 顾客

5、)4. 质量管理体系5. 管理职责6. 资源管理7. 产品实现8. 测量,分析和改进EEMS - CONFIDENTIAL4.2.3 文件控制 Document Control 文件控制 Document Control-确保在正确的时间正确的地点得到正确版本的正确文件.(包括外来文件) To ensure that right version of application document are available at right time and right place. (Including external document)条款4. 质量管理体系EEMS - CONFIDENTI

6、AL1. 内部文件控制Internal document controlEEMS文件控制流程条款4. 质量管理体系EEMS - CONFIDENTIALComplete the work instructions with the following headers in respective order.1. Purpose2. Scope3. Equipment and Materials4. Reference Documents5. Requirements6. AppendixUse ARIAL Font with Size 10 and all letters of Doc.tit

7、le should be capital XNote 1: Specify the responsibility for each instruction in the flow chart (eg. 1.1, 1.2, 2.1, 3.1) Guidelines for the flowchart symbols as shown:An activity or operation A decision matrix A connector (X denotes an alphabet) (used when continuous flow goes into the next page)Not

8、e 2: Form Numbering System Assign according to the document number eg. CM-TE-QC-001 / 01A Where 01 number of forms A Form revision numberComplete the Quality Procedure with the following headers in respective order.1. Purpose2. Scope3. Equipment and Materials4. Responsibility and References5. Proced

9、ures and Requirements6. AppendixUse ARIAL Font with Size 10 and all letters of Doc. Title should be capital条款4. 质量管理体系EEMS - CONFIDENTIALNote 3: The Work Instructions need to be written in English. For Work Instructions to be used by operators on the manufacturing floor will require the Chinese vers

10、ion to be included. Work Instructions on Equipment Maintenance and Equipment Buyoff are generally excluded. The final decision to have the Work Instructions in Chinese is to be decided by the relevant Module Manager. Note 4: The “Document Title” content must be written using capital fonts (i.e. IN P

11、RINT FORM)Note 5: Form Alignment Requirements a. For section with boxes for signature, ensure that the boxes contain 5 signature columns, and the column last vertical line is aligned to the change description last line. Space the signature boxes evenly. For spaces that are unfilled, leave them blank

12、. An example is listed below - SignatureNameDateDesignationNote 6: Change Description Limit the change description to no more than 10 recent revision change description summary. For example, if the change revision is at 18, the revision change description summary must contain revision 9 to 18 inform

13、ation only.Note 7: Submit WI to DCC requirement Originator must submit the work instructions that Complete the sign off to DCC before 2 days of effected. For example, if the effective date is 08-Oct-07, originator must submit work instruction to DCC before 06-Oct-07.条款4. 质量管理体系EEMS - CONFIDENTIAL条款4

14、. 质量管理体系EEMS - CONFIDENTIALControl of Reference documents Remark: All MSDS must be send to DCC control. 条款4. 质量管理体系EEMS - CONFIDENTIALTemporary Engineering Change Notification (TECN) EEMS - CONFIDENTIAL Confidential Documents Definition - Confidential documents are defined as documents containing in

15、formation, the unauthorized disclosure of which poses a threat to the customer or the company. Examples of confidential documents include quotations, patents, payroll and selected customer documents. Quotations and Payroll documents are kept by the relevant department manager. For customer documents

16、 which have been classified as confidential, they need to be stamped with the word “CONFIDENTIAL” on every page of the document. The “CONFIDENTIAL” documents need to be stored in a ledger / folder which have traceability of the documents. The documents can only be withdrawn by a department manager f

17、or reference only with the approval of the General Manager. No copies of the documents will be allowed. The “CONFIDENTIAL” documents must be kept under lock and key. 条款4. 质量管理体系EEMS - CONFIDENTIAL 4.2.3.1 工程规范(Engineering specifications) 组织应有一个过程，以保证按顾客要求的时间安排及时评审、发放和实施所有顾客工程标准/规范及其更改。及时评审应当尽快进行，不应超

18、过两个工作周。 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. 组织应保存每

19、项更改在生产中实施的日期的记录。实施应包括对文件的更新。 The organization shall maintain a record of the date on which each change is implemented in production. Implementation shall included documents. 条款4. 质量管理体系EEMS - CONFIDENTIAL2. 客户文件控制Customer document ControlRemark: All specifications are to be translated into internal

20、specifications within 5 working days. This does not apply to customers whose product or process is still in the engagement stage.EEMS - CONFIDENTIAL条款4. 质量管理体系EEMS - CONFIDENTIAL4.2.4 记录控制(Control of records)应建立并保持记录，以提供符合要求和质量管理体系有效运行的证据。记录应保持清晰、易于识别和检索。应编制形成文件的程序，以规定记录的标识、贮存、保护、检索、保存期限和处置所需的控制。Rec

21、ords shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed fo

22、r the identification, storage, protection, retrieval, retention time and disposition of records. 4.2.4.1 记录保存(Records retention)记录控制应满足法规和顾客要求。The control of records shall satisfy regulatory and customer requirements. 条款4. 质量管理体系EEMS - CONFIDENTIAL 6.2.2 能力, 意识和培训a) 确定从事影响产品与要求的符合性工作 的人员所必要的能力.b) 适用

23、时, 提供培训或采取其他措施以获得所 需要的能力c) 评价所采取措施的有效性d) 确保组织的人员认识到所从事活动的相关 性和重要性, 以及如何为实现质量目标作出 贡献.e) 保持教育, 培训, 技能和经验的适当记录.条款6. 资源管理EEMS - CONFIDENTIAL 6.2.2.2 培训 组织应建立并保持形成文件的程序, 识别培训需求并使所有从事影响产品要求符合性活动的人员具备能力. 承担特定任务的人员应具备要求的资格, 在满足顾客要求方面给予特别的关注. 6.2.2.3 岗位培训 对影响产品要求符合性的岗位, 组织应对新上岗或调整工作的人员提供岗位培训, 包括合同工和代理工作人员. 应

24、将不符合质量要求给顾客带来的后果告知对质量有影响的工作. 条款6. 资源管理EEMS - CONFIDENTIAL6.3.2 应急计划(Contingency plans) 组织应制定应急计划，以便在紧急情况下（如公用事业的供应中断、劳动力短缺，关键设备故障和外部退货等）满足顾客的要求。 The organization shall prepare contingency plans to satisfy customer requirements in the event of an emergency such as utility interruptions, labor shortag

25、es, key equipment failure and field returns. 条款6. 资源管理EEMS - CONFIDENTIALEEMS contingency plan条款6. 资源管理EEMS - CONFIDENTIAL 6.4 工作环境 组织应确定和管理为达到产品符合要求所需的工作环境 6.4.1 与产品质量相关的人员安全 组织应强调产品安全性和方法, 以最大程序地降低对员工造成的潜在风险, 特别是在设计和开发过程, 制造过程活动中. 6.4.2 生产现场的清洁 组织应保持生产现场处于与制造的需求相协调的有序, 清洁和维护的状态. 条款6. 资源管理EEMS - CO

26、NFIDENTIAL7产品实现(Product realization) 87.1 产品实现的策划(Planning of product realization) 97.2 与顾客有关的过程(Customer-related processes) 7.3 设计和开发 (对产品设计不适用, 仅适用过程设计)(Design and development) not available for product design, but still available for process design)7.4 采购(Purchasing)7.5 生产和服务提供(Production and ser

27、vice provision)7.6 监视和测量装置的控制(Control of monitoring and measuring devices)条款7. 产品实现EEMS - CONFIDENTIAL生产过程放行产品交付交付后活动顾客适用的设备工作指导监视和测量装置监视和测量产品特性的信息7.5.2确认7.5.3标识和可追溯性7.5.4顾客财产7.5.5产品防护7.5 生产和服务提供(Production and service provision)条款7. 产品实现EEMS - CONFIDENTIAL7.5.1 生产和服务提供的控制组织应策划并在受控条件下进行生产和服务提供. 适用时,

28、 受控条件应包括: 获得表述产品特性的信息 必要时, 获得作业指导书 使用适宜的设备 获得和使用监视和测量设备 实施监视和测量 放行, 交付和交付后活动的实施EEMS - CONFIDENTIAL7.5.1.1 控制计划 系统, 子系统, 部件和/或材料 投产前的正式生产 考虑设计FMEA和过程FMEA 控制内容 特殊特性控制方法 反应计划 评审和更新(更改时)EEMS - CONFIDENTIAL7.5.1.2 工作指导书 文化化 现场 转自质量计划, 控制计划和产品实现过程EEMS - CONFIDENTIAL7.5.1.3 作业准备的验证 作业准备的验证用于:- 首次运行- 材料转变-

29、工作转变 工作指导书(验证人员用) 适用时使用统计技术EEMS - CONFIDENTIAL7.5.1.4 预防和预知性维护包括关键设备, 工具和仪表: 计划维护活动 包装和防护 备件 评估改进目标EEMS - CONFIDENTIAL7.5.1.5 生产工装管理 设计, 制造和验证(包括外包) 维护设施和人员 储存和修复及/准备 更换方案 设计更改文件 修改/标识及状态EEMS - CONFIDENTIAL7.5.1.6 生产进度计划 满足顾客要求, 如JIT 关键过程订单驱动 关键阶段的生产信息的获取EEMS - CONFIDENTIAL7.5.1.7 服务信息的反馈 确保组织意识到外部的

30、不合格 服务关注反馈制造, 工程和设计EEMS - CONFIDENTIAL7.5.1.8 与顾客的服务协议 与顾客有服务协议时 验证有效性:- 服务中心- 专用工具或测量设备- 服务人员培训EEMS - CONFIDENTIAL7.5.2 生产和服务提供过程的确认 确认取得策划结果的过程能力 确定审批准则 设备和人员鉴定 特定方法 记录的要求 确认/再确认7.5.2.1 生产和服务提供过程的确认-补充 适用于所有生产和服务过程EEMS - CONFIDENTIAL7.5.3 标识和可追溯性 简单地说: - 标识-这是什么- 追溯-如何一步一步产生的 标识是必须的, 追溯按需要时进行, 控制并

31、记录产品的唯一 性标识 EEMS - CONFIDENTIAL7.5.4 顾客的财产 对(控制/使用)顾客的财产应给予爱护 包括知识产权和”硬件”EEMS - CONFIDENTIAL7.5.4.1 顾客所有的工装 包括工装, 制造, 试验, 检验工装和设备 永久性标识EEMS - CONFIDENTIAL7.5.5 产品防护 本要求适用于交付给顾客前的各阶段 防护包括标识, 搬运, 包装, 贮存和保护EEMS - CONFIDENTIAL7.5.5.1 储存和库存 按计划间隔检查库存产品 库存管理系统 优化库存周转, 如FIFO 陈旧产品类似不合格品EEMS - CONFIDENTIAL8

32、测量,分析和改进(Measurement, analysis and improvement)8.4 数据分析8.5.1 持续改进8.5.2 纠正措施8.5.3 预防措施8.3 不合格品控制8.2.4 产品监视和测量8.2.3 过程监视和测量8.2.2 内部审核8.2.1 顾客满意条款8. 测量,分析和改进EEMS - CONFIDENTIAL8测量,分析和改进(Measurement, analysis and improvement)98.1 总则(General) 组织应策划并实施以下方面所需的监视、测量、分析和改进过程：The organization shall plan and i

33、mplement the monitoring, measurement, analysis and improvement processes needed.a）证实产品的符合性； to demonstrate conformity of the product. b）确保质量管理体系的符合性； to ensure conformity of the quality management system, and c）持续改进质量管理体系的有效性。 to continually improve the effectiveness of the quality management system

34、. 这应包括对统计技术在内的适用方法及其应用程度的确定。 This shall include determination of applicable methods, including statistical techniques, and the extent of their use. 8.2 监视和测量(Monitoring and measurement)8.2.1 顾客满意(Customer satisfaction) 条款8. 测量,分析和改进EEMS - CONFIDENTIAL8.2.2 内部审核(internal audit)组织应按策划的时间间隔进行内部审核，以确定质量

35、管理体系是否：The organization shall conduct internal audits at planned intervals to determine whether the quality management systema） 符合策划的安排（见7.1）、本标准的要求以及组织所确定的质量管理体系的要求； conforms to the planned arrangements (see 7.1), to the requirements of this international standard and to the quality management syst

36、em requirements established by the organization, andb） 得到有效实施与保持。 is effectively implemented and maintained. 考虑拟审核的过程和区域的状况和重要性以及以往审核的结果，应对审核方案进行策划。应规定审核的准则、范围、频次和方法。审核员的选择和审核的实施应确保审核过程的客观性和公正性。审核员不应审核自己的工作。 An audit program shall be planned, taking into consideration the status and importance of th

37、e processes and areas to be audited, as well as the results of previous audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work. 策划和实施审核以及报告结果和保持记录（见4.2.4）的职责和要求应在形成文件的程序中作出规定。The responsibilities and requirements for planning and conducting aud

38、its, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure. 负责受审区域的管理者应确保及时采取措施，已消除所发现的不合格及其原因。跟踪活动应包括所采取措施的验证和验证结果的报告（见8.5.2）The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate

39、detected nonconformities and their causes, follow-up activities shall include the verification of the actions taken and the reporting of verification results (see 8.5.2)条款8. 测量,分析和改进 内审EEMS - CONFIDENTIAL8.2.2.1 质量管理体系审核(Quality management system audit) 组织应审核质量管理体系，以验证与本标准和任何附加的质量管理体系要求的符合性。The orga

40、nization shall audit its quality management system to verify compliance with this Technical Specification and any additional quality management system requirements.8.2.2.2 制造过程审核(Manufacturing process audit) 组织应对每一个制造过程进行审核以确定其有效性。The organization shall audit each manufacturing process to determine

41、its effectiveness. 8.2.2.3 产品审核(Product audit) 组织应以确定的频率，在生产和交付的适当阶段对其产品进行审核，以验证符合所有规定的要求如产品尺寸、功能、包装、标签。The organization shall audit products at appropriate stages of production and delivery to verify conformity to all specifies requirements, such as product dimensions, functionality, packaging and

42、labeling, at a defined frequency. 8.2.2.4 内部审核计划 内部审核应覆盖所有与质量管理有关的过程、活动和班次，且应按年度计划进行日程安排。 当内部外部不符合或顾客抱怨发生时，应适当增加审核频次。 注：每类审核应当使用特定的检查表。Internal audits shall cover all quality management related processes, activities and shifts, and shall be schedules according to an annual plan. When internal/extern

43、al nonconformities or customer complains occur, the audit frequency shall be appropriately increased. NOTE Specific checklists should be used for each audit. 8.2.2.5 内审员资格(Internal auditor qualification) 组织应具有有资格审核本标准要求的内部审核员（见6.2.2.2） The organization shall have internal auditors who are qualifies to audit the requirements of this Technical Specification (see 6.2.2.2)条款8. 测量,分析和改进 内审EEMS - CONFIDENTIAL条款8. 测量,分析和改进干- 内审EEMS - CONFIDENTIAL条款8. 测量,分析和改进 - 内审EEMS - CONFIDENTIAL条款8. 测量,分析和改进 内审EEMS - CONFIDENTIAL第三章质量管理体系过程方法的审核EEMS - CONFIDENTIAL1 1 过程方法的作用和目的过程方法