【正文】 features and requirements, including those which contain a subjective element。 通知認證團體 當 顧客將處所 (site)置于下列狀態(tài)時，供貨商應(yīng)于 (5)個工作天內(nèi)以書面通知他的認證團體： 1) Chrysler “Needs Improvement” 2) Fork Q1 Revocation 3) General Motors Level II Containment 433 Quality System – Element General – The supplier shall establish, document and maintain a quality system as amines of ensuring that product conforms to specified requirements. The supplier shall prepare a quality manual covering the requirements of this International Standard. The quality manual shall include or make reference to the quality system procedures and outline the structure of the documentation used in the quality system. NOTE 6： Guidance on quality manuals is given in ISO 10013. Quality System Procedures – The supplier shall a) prepare documented procedures consistent with the requirements of the International Standard and the supplier’sstated quality policy, and b) effectively implement the quality system and its documented procedures. For the purposes of this International Standard, the range and detail of the procedures that form part of the quality system shall be dependent upon the plexity of the work, the methods used, and the skills and training needed by personnel involved in carrying out the activity. NOTE 7： Documented procedures may make reference to work instructions that define how an activity is performed. Quality Planning – The supplier shall define and document how the requirements for quality will be met. Quality planning shall be consistent with all other requirements of a supplier’s quality system and shall be documented in a format to suit the supplier’s method of operation. The supplier shall give consideration to the following activities, as appropriate, in meeting the specified requirements for products, projects or contracts： a. the preparation of quality plans： b. the identification and acquisition of any controls, processes, equipment (including inspection and test equipment), fixtures, resources and skills that may be needed to achieve the required quality： c. ensuring the patibility of the design, the production process, installation, servicing, inspection and test procedures and the applicable documentation。 顧客滿意 供貨商應(yīng)制定一套決定顧客滿意的書面程序，程序包括決定的頻次及如何確保其客觀性和有效性。 公司層級數(shù)據(jù)的分析和應(yīng)用 供貨商針對品質(zhì)，作業(yè)績效 (生產(chǎn)力、效率、效益、低劣品質(zhì)的成本 )及產(chǎn)品和服務(wù)主要特性目前的品質(zhì)水準，明文記載其趨勢。應(yīng)采用客觀的流程來定義范圍及收集信息，包括收集信息的頻次及方式。經(jīng)營計劃的內(nèi)容不提供了第三者稽核。 管理審查 本項管理審查應(yīng)包括整 體品質(zhì)系統(tǒng)的所有要項，而非僅限于如 (預防行動 )要項中所特別指定者。供貨商決策時應(yīng)采用跨功能群組討論模式，且有能力使用顧客規(guī)定格式溝通必要的信息和數(shù)據(jù)。 f) 在內(nèi)部組織機能中代表顧客的需 求以對應(yīng)QS9000 的要求 (即管制特性的選擇，設(shè)定品質(zhì)目標，訓練，矯正與預防行動，產(chǎn)品設(shè)計與發(fā)展 )。該品質(zhì)政策必須相關(guān)于供貨商之組織目標與顧客需求與期望。 preventive actions, product design and development). The supplier shall identify resource requirements and provide adequate resources, including the assignment of trained personnel (see ).for management, performance of work and verification activities including internal quality audits. Management The supplier’s management with executive responsibility shall appoint a member of the supplier’s own management who, irrespective of other responsibilities, shall have defined authority for a) ensuring that a quality system is established, implemented and maintained in accordance with this international Standard, and b) reporting on the performance of the quality system to the supplier’s management for review and as a basis for improvement of the quality system. 管理責任─ 品質(zhì)政策─ 供貨商負經(jīng)營責任之管理階層應(yīng)界定并明文記載其對品質(zhì)所持之政策，包含品質(zhì)目標與對品質(zhì)之承諾。 b) 鑒定并記錄任何有關(guān)產(chǎn)品、流程及品質(zhì)系統(tǒng)的問題： c) 循既定管道發(fā)起、建議或提供解決 d) 驗證解決方案之執(zhí)行； e) 管制不合格產(chǎn)品被進一步加工、交貨或安裝，直到缺點或不滿意情況被矯正為止。 D plans, projections, and projects with appropriate funding 備注 5： 管理代表的責任亦可包含就供貨商品質(zhì)系統(tǒng)有關(guān)事務(wù)與外界團體的聯(lián)系 組織聯(lián)系接口 供貨商于概念研發(fā)直到生產(chǎn)等階段，應(yīng)建立系統(tǒng)確保對各項適當活動的管理 (參考先期產(chǎn)品品質(zhì)規(guī)劃和管制計劃參考手冊 )。此項審查的記錄應(yīng)予維持 (參閱 )。此項經(jīng)營計劃為管制文件。須建立衡量目前 和未來顧客期望的方法。 備注： 供貨商為達成經(jīng)營目標可賦予員工充分的授權(quán)。 2) 決定與顧客相關(guān)的重要趨勢和對等比較以支持現(xiàn)狀檢討、決策及長規(guī)劃。 備注： 顧滿意考量可顧及內(nèi)部，外部和最終顧客。 f. the identification of suitable verification at appropriate stages in the realization of product。品質(zhì)手冊應(yīng)包含或照品質(zhì)系統(tǒng)的書面程序，并對品質(zhì)系 統(tǒng)所采用文件其架構(gòu)予以概要說明。 品質(zhì)規(guī)劃 供貨商應(yīng)界定與書面化各項品質(zhì)要求是如何違成。 先期產(chǎn)品品質(zhì)規(guī)劃 – 供貨商應(yīng)建立和實施先期產(chǎn)品品質(zhì)規(guī)劃流程。 小組的工作須包括： ／定案 (見附錄 C)。 管制特性 – 當顧客的設(shè)計記錄 (參閱詞匯 )有標明管制特性時，供貨商的各項制程管制指導書及類似的檔(FMEA、管制計劃，操作說明 )，使用顧客指定的管制特性符號 (或者供貨商對等的符號或標記 )來標明那些會影響管制特制的制程步驟 (參見附錄C)?？尚行允侵冈诩榷ǖ慕y(tǒng)計制程能能力，產(chǎn)能且符合所有工程要求的前提下，評定某特定產(chǎn)品其設(shè)計、材料或生產(chǎn)制程的迫切性。 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