qs9000标准中英文对照及qs9000标准理解培训(3个文件)qs9000-管理培训(编辑修改稿)

qs9000标准中英文对照及qs9000标准理解培训(3个文件)qs9000-管理培训(编辑修改稿)内容摘要：

ntation。 d. the updating as necessary of quality control, inspection and testing techniques, including the development of new instrumentation。 e. the identification of any measurement requirement involving capability the needed capability to be developed。 f. the identification of suitable verification at appropriate stages in the realization of product。 g. the clarification of standards of acceptability for all features and requirements, including those which contain a subjective element。 品质系统 概述 供货商应建立与维持一个书面化的品质系统做为确保产合规定要求的手段。 供货商应准备一份涵盖本国际标准要求的品质手册。 品质手册应包含或照品质系统的书面程序，并对品质系 统所采用文件其架构予以概要说明。 备注 6： 品质手册的指导纲要请参阅 ISO 10013 品质系统程序 供货商应： 政策之各项书面程序，及。 为达到本国际标准之目的，构成品质系统之程序其范围与详细程度，端赖工作复杂性、采用的方法及执行业务参与人员所需技巧与训练等因素而定。 备注 7： 书面程序可参考对应那些界定作业如何执行的工作指导书。 品质规划 供货商应界定与书面化各项品质要求是如何违成。 品质规划应与供货商品质系统的所有其它要求一致，并以适合供货商作业方法的格式将其文书化。 供货商应适当 考量下列活动以达成产品、项目或合约的规定要求： a. 拟定各项品质计划； b. 鉴定与取得为违成需求品质所需之任何管制、流程、设备 (含检验及测试设备 )、治具、资源及技术； c. 确保设计、生产流程、安装、服务、检验与测试等程序，与适用文件间彼此之一致性； d. 必要时，得更新质量管理、检验与测试技术，含新仪器的开发； e. 鉴定任何量测需求其能力超出现有已知技术水准者，应有充裕的时间开发所需能力； f. 在产品实现的各适当阶段鉴定其适切的验证； g. 厘清所有性能与要求的允收标准，包括那些具主观因素者； h. the identification and preparation of quality 533 records (see ) NOTE 8:The quality plans referred to [see ] may be in the form of a reference to the appropriate documented procedures that form integral part of the supplier39。 s quality system. Advanced Product Quality Planning – The supplier shall establish and implement an advanced product quality planning process. The supplier should convene internal multidisciplinary teams to prepare for production of new or changed products. These teams should use appropriate techniques identified in the Advanced Product Quality Planning and Control Plan reference manual. Similar techniques that acplish the intent are acceptable. Team actions should include：  Development/finalization of special characteristics (see Appendix C)  Development and review of FMEAs  Establishment of actions to reduce the potential failure modes with high risk priority numbers  Development or review of Control Plans Special Characteristics – The supplier’s process control guidelines and similar documents ( FMEA’s, Control Plans, Operation Instructions) shall be marked with the customer’s special characteristic symbol (or the supplier’s equivalent symbol or notation) to indicate those process steps that affect Special characteristics, when Special Characteristics are identified on the customer design record (see Glossary) (see Appendix C) NOTE： Initially, the customer may determine Special Characteristics and identify them. Special Characteristics may be identified from any product characteristics category, ( dimensional, material, appearance, performance.) Feasibility Reviews – The supplier shall investigate and confirm the manufacturing feasibility of proposed products prior to contracting to produce those products. Feasibility is an assessment of the suitability of a particular design, material, or process for production, while conforming to all engineering requirements at the required statistical process capability and at specified volumes. Feasibility reviews should be documented using the Team feasibility mitment in the Advanced Product Quality Planning and Control Plan Reference manual. Product Safety – Due care and product safety shall be considered in the supplier’s design control (element ) and process control (element ) policies and practices. The supplier should promote internal awareness of safety consideration relative to the supplier’s product. h. 品质记录之鉴别与调制 (参阅 ) 备注 8： 上述之品质计划成参阅 ()其形式可以构成供货商品质系统之适当书面程序对照的方式表示。 先期产品品质规划 – 供货商应建立和实施先期产品品质规划流程。 供货商须召集内部的跨功能小组，以准备新产品或变更产品的量产。 这些小组须采用规定在 先期产品品质规划和管制计划 参考手册的各种适当的技术。 但也可采用能达成本项意图的类似技术。 小组的工作须包括： ／定案 (见附录 C)。 效模式。 管制特性 – 当顾客的设计记录 (参阅词汇 )有标明管制特性时，供货商的各项制程管制指导书及类似的档(FMEA、管制计划，操作说明 )，使用顾客指定的管制特性符号 (或者供货商对等的符号或标记 )来标明那些会影响管制特制的制程步骤 (参见附录C)。 备注： 初期时，顾客可能会确定管制特性并加以标识。 管制特性可能来自任何产品特性的种类，即尺寸、材质、外观 ,功能。 可性审查 – 供货商在签定合约以 生产产品之前，应对所规划的产品探讨及确认制造的可行性。 可行性是指在既定的统计制程能能力，产能且符合所有工程要求的前提下，评定某特定产品其设计、材料或生产制程的迫切性。 可行性审查结果的记载须使用先 期产品品质规划和管制计划 参考手册里的小组可行性承诺书。 产品安全性 – 供货商的设计管制 ()及制程管制 ()，其政策与实务应考量关注产品的安全性。 供货商需在内部推广对其产品安全性考量的认知。 Process Failure Mode and Effects Analysis (Process 633 FMEAs) Process FMEAs shall consider all Special Characteristics. Efforts shall be taken to improve the process to achieve defect prevention rather than defect detection. Certain customers have FMEA review and approval requirements that shall be met prior to production part approval (see Section II). Refer to the Potential Failure Mode and Effects Analysis reference manual. Mistake Proofing – The supplier shall utilize appropriate mistake proofing methodologies during the planning of processes, facilities, equipment and tooling. The Control Plan – The supplier shall develop Control Plans at the system, subsystem, ponent and or material level, as appropriate for the product supplied. The Control Plan shall include the information required in the Control plan form in Appendix J. The Control Plan requirement enpasses process producing bulk materials (. steel, plastic resin, paint)as well as those producing parts. The output of the advanced quality planning process, beyond the development of robust processes, is a Control Plan. Control Plans shall be revised or updates when products or processes differ significantly from those in current production. The Control Plan should list the controls used for processes control (see ).The Co。