【文章內容簡介】 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。 品質系統(tǒng) 概述 供貨商應建立與維持一個書面化的品質系統(tǒng)做為確保產合規(guī)定要求的手段。供貨商應準備一份涵蓋本國際標準要求的品質手冊。品質手冊應包含或照品質系統(tǒng)的書面程序，并對品質系 統(tǒng)所采用文件其架構予以概要說明。 備注 6： 品質手冊的指導綱要請參閱 ISO 10013 品質系統(tǒng)程序 供貨商應： 政策之各項書面程序，及 。 為達到本國際標準之目的，構成品質系統(tǒng)之程序其范圍與詳細程度，端賴工作復雜性、采用的方法及執(zhí)行業(yè)務參與人員所需技巧與訓練等因素而定。 備注 7： 書面程序可參考對應那些界定作業(yè)如何執(zhí)行的工作指導書。 品質規(guī)劃 供貨商應界定與書面化各項品質要求是如何違成。品質規(guī)劃應與供貨商品質系統(tǒng)的所有其它要求一致，并以適合供貨商作業(yè)方法的格式將其文書化。供貨商應適當 考量下列活動以達成產品、項目或合約的規(guī)定要求： a. 擬定各項品質計劃； b. 鑒定與取得為違成需求品質所需之任何管制、流程、設備 (含檢驗及測試設備 )、治具、資源及技術； c. 確保設計、生產流程、安裝、服務、檢驗與測試等程序，與適用文件間彼此之一致性； d. 必要時，得更新質量管理、檢驗與測試技術，含新儀器的開發(fā)； e. 鑒定任何量測需求其能力超出現(xiàn)有已知技術水準者，應有充裕的時間開發(fā)所需能力； f. 在產品實現(xiàn)的各適當階段鑒定其適切的驗證； g. 厘清所有性能與要求的允收標準，包括那些具主觀因素者； 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. 品質記錄之鑒別與調制 (參閱 ) 備注 8： 上述之品質計劃成參閱 ()其形式可以構成供貨商品質系統(tǒng)之適當書面程序對照的方式表示。 先期產品品質規(guī)劃 – 供貨商應建立和實施先期產品品質規(guī)劃流程。供貨商須召集內部的跨功能小組，以準備新產品或變更產品的量產。這些小組須采用規(guī)定在 先期產品品質規(guī)劃和管制計劃 參考手冊的各種適當的技術。但也可采用能達成本項意圖的類似技術。 小組的工作須包括： ／定案 (見附錄 C)。 。 效模式。 。 管制特性 – 當顧客的設計記錄 (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)。 備注： 初期時，顧客可能會確定管制特性并加以標識。管制特性可能來自任何產品特性的種類，即尺寸、材質、外觀 ,功能。 可性審查 – 供貨商在簽定合約以 生產產品之前，應對所規(guī)劃的產品探討及確認制造的可行性?？尚行允侵冈诩榷ǖ慕y(tǒng)計制程能能力，產能且符合所有工程要求的前提下，評定某特定產品其設計、材料或生產制程的迫切性。 可行性審查結果的記載須使用先 期產品品質規(guī)劃和管制計劃 參考手冊里的小組可行性承諾書。 產品安全性 – 供貨商的設計管制 ()及制程管制 ()，其政策與實務應考量關注產品的安全性。供貨商需在內部推廣對其產品安全性考量的認知。 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