IATF16949 中英文对照版 201710 - 图文(7)

8.3.2.2 产品设计技能 组织应确保负有产品设计职责的人员有能力达成设计要求，并具备适用的产品设计工具和技术技能。适合的工具和技术应得到组织的识别。 注：基于数学的数字化数据的应用便是一种产品设计技能。 8.3.2.3 带有嵌入式软件的产品的开发 组织应有一个质量保证过程，用于其带有内部开发的嵌入式软件的产品。应采用软件开发评估方法来评估组织的软件开发过程。组织应按照风险和对顾客潜在影响的优先级，为软件开发能力自评估保留形成文件的信息。 组织应将软件开发纳入其内部审核方案的范围（见第9.2.2.1条）。 achieve design requirements and are skilled in applicable product design tools and techniques. Applicable tools and techniques shall be identified by the organization. NOTE An example of product design skills is the application of digitized mathematically based data. 8.3.2.3 Development of products with embedded software The organization shall use a process for quality assurance for their products with internally developed embedded software，A software development assessment methodology shall be utilized to assess the organization's software development process. Using prioritization based on risk and potential impact to the customer，the organization shall retain documented information of a software development capability self-assessment. The organization shall include software development within the scope of their internal audit programme（see Section 9.2.2.1）. 8.3.3 Design and development inputs See ISO 9001:2015 requirements. The organization shall determine the requirements essential for the specific types of products and services to be designed and developed. The organization shall consider: a) functional and performance requirements; b) information derived from previous similar design and development activities; c) statutory and regulatory requirements; d) standards or codes of practice that the organization has committed to implement; e) potential consequences of failure due to the nature of the products and services. Inputs shall be adequate for design and development purposes, complete and unambiguous. Conflicting design and development inputs shall be resolved. The organization shall retain documented information on design and development inputs. 8.3.3 设计和开发输入 见ISO 9001:2015的要求。 组织应针对所设计和开发的具体类型的产品和服务，确定必需的要求，要求应考虑： a) 功能和性能要求； b) 来源于以前类似设计和开发活动的信息； c) 法律法规要求； d) 组织承诺实施的标准或行业规范； e) 由产品和服务性质所导致的潜在失效后果。 针对设计和开发的目的，输入应是充分和适宜的，且应完整、清楚。 相互矛盾的设计和开发输入应得到解决。 组织应保留有关设计和开发输入的成文信息。 8.3.3.1 Product design input The organization shall identify，document，and review 8.3.3.1 产品设计输入 组织应对作为合同评审结果的产品设计输入要求进行识别、形成文件并进行评审。产品设计输入要求包括但不限于： a） 产品规范，包括但不限于特殊特性（见第8.3.3.3条）； b） 边界和对接要求； c） 标识、可追溯性和包装； d） 对涉及的替代选择的考虑； e） 对输入要求风险的评估，以及对组织缓解/管理风险（包括来自可行性分析的风险）的能力的评估； f） 产品要求符合性的目标，包括防护、可靠性、耐久性、可服务性、健康、安全、环境、开发时程安排和成本等方面； g） 顾客确定的目的国（如有提供）的使用法律法规要求； h） 嵌入式软件的要求。 组织应有一个过程，将从以前的设计项目、竞争产品分析（标杆）、供应商反馈、内部输入、使用现场数据和其他相关资源中获取的信息，推广应用于当前和未来相似性质的项目。 注：使用权衡曲线是考虑设计的替代选择的一种方法。 8.3.3.2 制造过程设计输入 组织应对制造过程设计输入要求进行识别、形成文件并进行评审，包括但不限于： a） 产品设计输出的数据，包括特殊特性； b） 生产力、过程能力、时程安排及成本的目标； c） 制造技术替代选择； d） 顾客要求，如有； e） 以往的开发经验； f） 新材料； g） 产品搬运和人体工学要求；以及 h） 制造设计和装配设计。 product design input requirements as a result of contract review. Product design input requirements include but are not limited to the following: a）product specifications including but not limited to special characteristics（see Section 8.3.3.3）； b）boundary and interface requirements； c）identification，traceability，and packaging； d）consideration of design alternatives； e）assessment of risks with the input requirements and the organization's ability to mitigate/manage the risks，including from the feasibility analysis； f）targets for conformity to product requirements including preservation，reliability，durability，serviceability，health，safety，environmental，development timing，and cost； g）applicable statutory and regulatory requirements of the customer-identified country of destination，if provided； h）embedded software requirements. The organization shall have a process to deploy information gained from previous design projects，competitive product analysis（benchmarking），supplier feedback，internal input，field data，and other relevant sources for current and future projects of a similar nature. NOTE One approach for considering design alternatives is the use of trade-off curves. 8.3.3.2 Manufacturing process design input The organization shall identify，document，and review manufacturing process design input requirements including but not limited to the following: a）product design output data including special characteristics； b）targets for productivity，process capability，timing，and cost； c）manufacturing technology alternatives； d）customer requirements，if any； e）experience from previous developments； f）new materials； g）product handling and ergonomic requirements；and h）design for manufacturing and design for assembly. 制造过程设计应包括，针对问题适当的重要性程度，和所遭遇到的风险相称的程度来使用防错方法。 8.3.3.3 特殊特性 组织应采用多方论证方法来建立、形成文件并实施用于识别特殊特性的过程，包括顾客确定的以及组织风险分析所确定的特殊特性，应包括： a) 将特殊特性记录进产品和/或生产文件（按要求）、相关风险分析（例如过程FMEA）、控制计划和标准的工作/操作说明书；特殊特性用特定的标记进行标识，并且记录在创建的生产文件中，或者对于这些特殊特性要求的控制； b) 为产品和生产过程的特殊特性开发控制和监视策略； c) 顾客规定的批准，如有要求； d) 遵循顾客规定的定义和符号或组织的等效符号或标记，如符号转换表所示。如有要求，应向顾客提交符号转换表。 The organization shall apply controls to the design and development process to ensure that: a) the results to be achieved are defined; 8.3.4 设计和开发控制 b) reviews are conducted to evaluate the ability of the results of design and development to meet requirements; 见ISO9001：2015的要求 c) verification activities are conducted to ensure that the 组织应对设计和开发过程进行控制，以确保： design and development outputs meet the input a) 规定拟获得的结果； b) 实施评审活动，以评价设计和开发的结果满足要requirements; d) validation activities are conducted to ensure that the 求的能力； c) 实施验证活动，以确保设计和开输出满足输入的resulting products and services meet the requirements for the specified application or intended use; 要求； d) 实施确认活动，以确保产品和服务能够满足规定e) any necessary actions are taken on problems determined during the reviews, or verification and 的使用要求或者预期用途； e) 针对评审、验证和确认过程中确定的问题采取必validation activities; f) documented information of these activities is retained. 要措施； NOTE Design and development reviews, verification and The manufacturing process design shall include the use of error-proofing methods to a degree appropriate to the magnitude of the problem（s）and commensurate with the risks encountered. 8.3.3.3 Special characteristics The organization shall use a multidisciplinary approach to establish，document，and implement its process（es）to identify special characteristics，including those determined by the customer and the risk analysis performed by the organization，and shall include the following: a）documentation of special characteristics in the product and/or manufacturing documents（as required）， relevant risk analysis（such as Process FMEA），control plans，and standard work/operator instructions；special characteristics are identified with specific markings and are documented in the manufacturing documents which show the creation of , or the controls required, for these special characteristics； b）development of control and monitoring strategies for special characteristics of products and production processes； c）customer-specified approvals，when required； d）compliance with customer-specified definitions and symbols or the organization's equivalent symbols or notations，as defined in a symbol conversion table. The symbol conversion table shall be submitted to the customer，if required. 8.3.4 Design and development controls See ISO 9001:2015 requirements. f) 保留这些活动的成文信息。 validation have distinct purposes. They can be 注：设计和开发的评审、验证和确认具有不同的目conducted separately or in any combination, as is suitable for 的。根据组织的产品和服务的具体情况，可单独或the products and services of the organization. 以任意组合的方式进行。 8.3.4.1 监视 产品和过程的设计和开发期间特定阶段的测量应被确定、分析，以汇总结果的形式来报告，作为对管理评审的输入（见第9.2.2.1条）。 在顾客有要求时，应在顾客规定或同意的阶段向顾客报告对产品和过程开发活动的测量。 注：在适当的情况下，这些测量可包括质量风险、成本、前置期、关键路径和其它测量。 8.3.4.2 设计和开发确认 应根据顾客要求，包括适用的行业和政府机构发布的监控标准，对设计和开发进行确认。设计和开发确认的时程安排应与顾客规定的时程相符。 在与顾客有合同约定的情况下，设计和开发确认应包括评价组织的产品，包括嵌入式软件在最终顾客产品系统内的相互作用。 8.3.4.3原型样件方案 当顾客要求时，组织应制定原型样件方案和控制计划。组织应尽可能地使用与正式生产相同的供应商、工装和制造过程。 应监视所有的性能试验活动的及时性完成和要求符号性。 当服务被外包时，组织应将控制的类型和程度纳入其质量管理体系的范围，以确保外包服务符合要求（见ISO 9001第8.4条）。 8.3.4.1 Monitoring Measurements at specified stages during the design and development of products and processes shall be defined，analysed，and reported with summary results as an input to management review（see Section9.3.2.1）. When required by the customer，measurements of the product and process development activity shall be reported to the customer at stages specified，or agreed to，by the customer. NOTE When appropriate，these measurements may include quality risks，costs，lead times，critical paths，and other measurements. 8.3.4.2 Design and development validation Design and development validation shall be performed in accordance with customer requirements，including any applicable industry and governmental agency-issued regulatory standards. The timing of design and development validation shall be planned in alignment with customer-specified timing，as applicable. Where contractually agreed with the customer，this shall include evaluation of the interaction of the organization's product，including embedded software，within the system of the final customer's product. 8.3.4.3 Prototype programme When required by the customer，the organization shall have a prototype programme and control plan. The organization shall use，whenever possible，the same suppliers，tooling，and manufacturing processes as will be used in production. All performance-testing activities shall be monitored for timely completion and conformity to requirements. When services are outsourced，the organization shall include the type and extent of control in the scope of its quality management system to ensure that outsourced services conform to requirements（see ISO 8.3.4.4产品批准过程 组织应建立、实施并保持一个符合顾客规定要求的产品和制造批准过程。 在向顾客提交其零件批准之前，组织应根据ISO 9001第8.4.3条，对外部提供的产品和服务进行审批。 如顾客要求，组织应在发运之前获得形成文件的产品批准。此类批准的记录应予以保存。 注：产品的批准应当是制造过程验证的后续步骤。 9001，Section 8.4）. 8.3.4.4 Product approval process The organization shall establish，implement，and maintain a product and manufacturing approval process conforming to requirements defined by the customer（s）. The organization shall approve externally provided products and services per ISO 9001，Section 8.4.3，prior to submission of their part approval to the customer. The organization shall obtain documented product approval prior to shipment，if required by the customer. Records of such approval shall be retained. NOTE Product approval should be subsequent to the verification of the manufacturing process. 8.3.5 Design and development outputs See ISO 9001:2015 requirements. The organization shall ensure that design and development outputs: a) meet the input requirements; b) are adequate for the subsequent processes for the provision of products and services; c) include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria; d) specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision. The organization shall retain documented information on design and development outputs. 8.3.5设计和开发输出 见ISO 9001:2015要求。 组织应确保设计和开发输出： a) 满足输入的要求； b) 满足后续产品和服务提供过程的需要； c)包含或引用监视和测量的要求，适当时，包括接收准则； d) 规定产品和服务特性，这些特性对于预期目的、安全和正确提供是必需的。 组织应保留有关设计和开发输出的成文信息。 8.3.5.1 Design and development outputs —supplemental The product design output shall be expressed in terms that can be verified and validated against product 8.3.5.1设计和开发输出——补充 design input requirements. The product design output shall include but is not limited to the following，as 产品设计输出的表达方式应适合于对照产品设计输applicable: 入要求进行验证和确认。产品设计输出应包括但不a）design risk analysis（FMEA）； 限于（如适用）： b）reliability study results； a） 设计风险分析（FMEA）； c）product special characteristics； b） 可靠性研究结果； d）results of product design error-proofing, such c） 产品特殊特性； d） 产品设计防错结果，例如：DFSS、DFMAas DFSS, DFMA, and FTA； e）product definition including 3D models,