IATF16949 中英文对照版 201710 - 图文(8)

和FTA； e） 产品定义，包括三维模型、技术数据包、产品制造信息，以及几何尺寸与公差（GD&T）； f） 二维图纸、产品制造信息以及几何尺寸与公差（GD&T）； g） 产品设计评审结果； h） 服务诊断指南及修理和可服务性说明； i） 服务件要求； j） 运输的包装和标签要求。 注：临时设计输出应当包含通过权衡过程正在解决的过程问题。 8.3.5.2制造过程设计输出 组织应对制造过程设计输出形成文件，采用的方式应能够对照制造过程设计输入进行验证。组织应对照制造过程设计输入要求对输出进行验证。制造过程设计输出应包括但不限于： a） 规范和图纸； b） 产品和制造过程的特殊特性； c） 对影响特性的过程输入变量的识别； d） 用于生产和控制的工装和设备，包括设备和过程的能力研究； e） 制造过程流程图/制造过程平面布置图，包括产品、过程和工装的联系； f） 产能分析； g） 制造过程FMEA; h） 维护计划和说明； i） 控制计划（见附录A）； j） 标准作业和工作指导书； k） 过程批准的接收准则； l） 质量、可靠性、可维护性和可测量性的数据； m） 适用时，防错识别和验证的结果； n） 产品/制造过程不符合的快速探测、反馈和纠正的方法。 technical data packages, product manufacturing information, and geometric dimensioning & tolerancing（GD&T）； f）2D drawings, product manufacturing information, and geometric dimensioning & tolerancing（GD&T）； g）product design review results； h）service diagnostic guidelines and repair and serviceability instructions； i）service part requirements； j）packaging and labeling requirements for shipping. NOTE Interim design outputs should include any engineering problems being resolved through a trade-off process. 8.3.5.2 Manufacturing process design output The organization shall document the manufacturing process design output in a manner that enables verification against the manufacturing process design inputs. The organization shall verify the outputs against manufacturing process design input requirements. The manufacturing process design output shall include but is not limited to the following: a）specifications and drawings； b）special characteristics for product and manufacturing process； c）identification of process input variables that impact characteristics； d）tooling and equipment for production and control，including capability studies of equipment and process（es）； e）manufacturing process flow charts/layout，including linkage of product，process，and tooling； f）capacity analysis； g）manufacturing process FMEA； h）maintenance plans and instructions； i）control plan（see Annex A）； j） standard work and work instructions； k）process approval acceptance criteria； I） data for quality，reliability，maintainability，and measurability； m）results of error-proofing identification and verification，as appropriate； n）methods of rapid detection，feedback，and correction of product/manufacturing process nonconformities. 8.3.6 Design and development changes See ISO 9001:2015 requirements. The organization shall identify, review and control changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements. The organization shall retain documented information on: a) design and development changes; b) the results of reviews; c) the authorization of the changes; d) the actions taken to prevent adverse impacts. 8.3.6设计和开发更改 见ISO 9001:2015要求。 组织应对产品和服务设计和开发期间以及后续所做的更改提供适当的识别、评审和控制，以确保这些更改对满足要求不会产生不利影响。 组织应保留下列方面的成文信息： a) 设计和开发更改 b) 评审的结果； c) 更改的授权； d) 为防止不利影响而采取的措施。 8.3.6.1 Design and development changes - supplemental 8.3.6.1 设计和开发更改——补充 The organization shall evaluate all design changes after initial product approval，including those 组织应评价初始产品批准之后的所有设计更改，包proposed by the organization or its suppliers，for 括组织或其供应商提议的更改，评价这些更改对可form，function，performance，装配性、外形、功能、性能和/或耐久性的影响。这potential impact on fit，些更改应对照顾顾客要求进行确认，并在生产实施之前得到内部批准。 如顾客有要求，组织应在生产实施之前，从顾客处获得形成文件的批准和弃权。 对于带有嵌入式软件的产品，组织应对软硬件的版本级别形成文件，作为更改记录的一部分。 and/or durability. These changes shall be validated against customer requirements and approved internally，prior to production implementation. If required by the customer，the organization shall obtain documented approval，or a documented waiver，from the customer prior to production implementation. For products with embedded software，the organization shall document the revision level of software and hardware as part of the change record. 8.4 Control of externally provided processes，products and services 8.4.1 General See ISO 9001:2015 requirements. 8.4外部提供的过程、产品和服务的控制 8.4.1总则 The organization shall ensure that externally provided processes, products and services conform to requirements. 见ISO 9001:2015的要求。 组织应确保外部提供的过程、产品和服务符合要求。 The organization shall determine the controls to be applied 在下列情况下，组织应确定对外部提供的过程、产品和服务实施的控制： a) 外部供方的产品和服务构成组织自身的产品和服务的一部分； b) 外部供方代表组织直接将产品和服务提供给顾客； c) 组织决定由外部供方提供过程或部分过程。 组织应基于外部供方按照要求提供过程、产品和服务的能力，确定并实施外部供方的评价、选择、绩效监视以及再评价的准则。对于这些活动和由评价引起的任何必要的措施，组织应保留成文信息。 to externally provided processes, products and services when: a) products and services from external providers are intended for incorporation into the organization’s own products and services; b) products and services are provided directly to the customer(s) by external providers on behalf of the organization; c) a process, or part of a process, is provided by an external provider as a result of a decision by the organization. The organization shall determine and apply criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements. The organization shall retain documented information of these activities and any necessary actions arising from the evaluations.. 8.4.1.1 General-supplemental The organization shall include all products and 8.4.1.1总则——补充 services that affect customer requirements such as 组织应将影响顾客要求的所有产品和服务，例如子sub- assembly，sequencing，sorting，rework，and 总成、排序、挑选、返工和校准服务，纳入其对外calibration services in the scope of their definition of 部提供的产品、过程和服务的定义范围。 externally provided products，processes，and services. 8.4.1.2 Supplier selection process 8.4.1.2供应商选择过程 The organization shall have a documented supplier 组织应有一个形成文件的供应商选择过程。选择过selection process. The selection process shall include: 程应包括： a）an assessment of the selected supplier's risk to a） 对所有供应商产品符合性以及组织向其顾product conformity and uninterrupted supply of the 客不间断产品供应的风险评估； organization's product to their customers； b） 相应质量和交付需求； b）relevant quality and delivery performance； c） 对供应质量管理体系的评价； c）an evaluation of the supplier's quality d） 多方论证决策；以及 e） 对软件开发能力的评估，如适用。 management system； 应当考虑的其它供应商选择标准则包括： ——汽车业务量（绝对值，以及包括占总业务量的百分比）； ——财务稳定性； ——采购的产品、材料和服务的复杂性； ——所需技术（产品和过程）； ——可用资源（如：人员、基础设施）的充分性； ——设计和开发能力（包括项目管理）； ——制造能力； ——更改管理过程； d）multidisciplinary decision making； and e）an assessment of software development capabilities，if applicable. Other supplier selection criteria that should be considered include the following: - volume of automotive business（absolute and as a percentage of total business）； - financial stability； - purchased product，material，or service ——业务连续性规划（如：防灾准备、应急计划）； ——物流过程； ——顾客服务。 8.4.1.3顾客指定的货源（亦称“指向性购买”） 顾客指定时，组织应从顾客指定的货源处采购产品、材料和服务。 第8.4条的所有要求（除了IATF16949第8.4.1.2条中的要求）适用于组织对顾客指定货源的控制，除非组织与顾客之间的合同另有特殊约定。 complexity； - required technology（product or process）； - adequacy of available resources（e.g.，people，infrastructure）； - design and development capabilities（including project management）； - manufacturing capability； - change management process； - business continuity planning（e.g.，disaster preparedness，contingency planning）； - logistics process； - customer service. 8.4.1.3 Customer-directed sources（also known as “Directed-Buy”） When specified by the customer，the organization shall purchase products，materials，or services from customer-directed sources. All requirements of Section 8.4（except the requirements in IATF 16949，Section 8.4.1.2）are applicable to the organization's control of customer-directed sources unless specific agreements are otherwise defined by the contract between the organization and the customer. 8.4.2 Type and extent of control See ISO 9001:2015 requirements. The organization shall ensure that externally provided processes, products and services do not adversely affect the organization’s ability to consistently deliver conforming products and services to its customers. The organization shall: a) ensure that externally provided processes remain within the control of its quality management system; b) define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output; c) take into consideration: 1) the potential impact of the externally provided processes, products and services on the organization’s ability to consistently meet customer and applicable statutory and regulatory requirements; 2) the effectiveness of the controls applied by the 8.4.2控制的类型和程度 见ISO 9001:2015要求。 组织应确保外部提供的过程、产品和服务不会对组织稳定地向顾客交付合格的产品和服务的能力产生不利影响。 组织应： a) 确保外部提供的过程保持在其质量管理体系的控制之中； b) 确定对外部供方的控制及其输出结果的控制； c) 考虑： 1) 外部提供的过程、产品和服务对组织稳定地满足顾客要求和适用的法律法规要求的能力的潜在影响； 2) 外部供方实施控制的有效性。 d) 确定必要的验证或其他活动，以确保外部提供的过程、产品和服务满足要求。 8.4.2.1控制的类型和程度----补充 组织应有一个形成文件的过程，以识别外包过程并选择控制的类型和程度，用于验证外部提供的产品、过程和服务对内部（组织的）要求和外部顾客要求的符合性。 该过程应包括根据供应商绩效和产品、材料和服务风险评估，增加或减少控制类型和程度以及开发活动的准则和措施。 当特性或零件未经验证或者控制在组织的质量管理体系“传递”时，组织应确保其在制造过程中适当位置的适当控制。 8.4.2.2 法律法规要求 组织应有形成文件的过程，确保所采购的产品、过程和服务符合收货国、发运国和顾客确定的目的国（如有提供）的现行适用法律法规要求。 如果顾客为特定产品符合法律法规要求确定了特殊控制，组织应确保按照规定实施并保持这些控制，包括在供应商处。 8.4.2.3 供应商质量管理体系开发 组织应要求其汽车产品和服务供应商开发、实施并改进质量管理体系(QMS)，最终目标是通过本汽车QMS标准的认证。 采用基于风险的方式，组织应为每个供应商定义质量管理体系开发的最低可接受水平和目标质量管理体系的开发水平。 得到顾客授权，质量管理体系初始最低要求是通过第三方认证的ISO9001。基于当前的绩效以及对顾客external provider; d) determine the verification, or other activities, necessary to ensure that the externally provided processes, products and services meet requirements. . 8.4.2.1 Type and extent of control - supplemental The organization shall have a documented process to identify outsourced processes and to select the types and extent of controls used to verify conformity of externally provided products，processes，and services to internal（organizational）and external customer requirements. The process shall include the criteria and actions to escalate or reduce the types and extent of controls and development activities based on supplier performance and assessment of product，material，or service risks. Where characteristics or components “pass through” the organization’s quality management system without validation of controls, the organization shall ensure that the appropriate controls are in place at the point of manufacture. 8.4.2.2 Statutory and regulatory requirements The organization shall document their process to ensure that purchased products，processes，and services conform to the current applicable statutory and regulatory requirements in the country of receipt，the country of shipment，and the customer-identified country of destination，if provided. If the customer defines special controls for certain products with statutory and regulatory requirements，the organization shall ensure they are implemented and maintained as defined，including at suppliers. 8.4.2.3 Supplier quality management system development The organization shall require their suppliers of automotive products and services to develop，implement，and improve a quality management system (QMS) with the ultimate objective of becoming certified to this Automotive QMS Standard. Using a risk-based model, the organization shall define a minimum acceptable level of QMS development and a target QMS development level for each supplier.