【正文】 documented to ensure that the plan is followed and municated throughout the anization as appropriate. 追蹤、檢討、更新及修訂計(jì)劃的方法應(yīng)以明文規(guī)定，以確保該計(jì)劃在整體組織中被適當(dāng)?shù)呢瀼嘏c溝通。 Trends in data and information should be pared with progress toward overall business objectives, and lead to action to support: 數(shù)據(jù)和資訊中所顯示之趨勢(shì)應(yīng)與整體經(jīng)營目標(biāo)的進(jìn)展相比較，並轉(zhuǎn)化成據(jù)以行動(dòng)的資訊以支持： 1) Development of priorities for prompt solutions to customerrelated problems, 顧客相關(guān)問題解決方案的優(yōu)先須序。這些趨勢(shì)需與競爭廠商，或適當(dāng)?shù)钠髽I(yè)標(biāo)竿來比較，並經(jīng)高層管理階層審查。39。 NOTE 6: Guidance on quality manual is given in ISO 10013. 備注 6：品質(zhì)手冊(cè)的指導(dǎo)綱要請(qǐng)參閱 ISO 10013. Quality System Procedures 品質(zhì)系統(tǒng)程序 The supplier shall a) prepare documented procedures consistent with the requirements of this International Standard and the supplier39。 Quality Planning 品質(zhì)規(guī)劃 The supplier shall determine and document how the requirements for quality will be met. Quality planning shall be consistent with all other requirements of a supplier39。供應(yīng)商應(yīng)適當(dāng)考量下列活動(dòng)以達(dá)成產(chǎn)品、專案或合約的規(guī)定要求： a) the preparation of qualify plans: 擬定各項(xiàng)品質(zhì)計(jì)劃； 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. 鑑定與取得為達(dá)成需求品質(zhì)所需之任何管制、流程、設(shè)備（含檢驗(yàn)及測試設(shè)備）、治具、資源及技術(shù)； c) Ensuring the patibility of the design, the production process, installation, servicing, inspection and test procedures and the application documentation. 確保設(shè)計(jì)、生產(chǎn)流程、安裝、服務(wù)、檢驗(yàn)與測試等企業(yè) ()大量管理資料下載 Page : 11 / 46 程 序，與適用文件間彼此之一致性； d) The updating, as necessary, of quality control, inspection and testing techniques, including the development of new instrumentation. 必要時(shí) ，得更新品質(zhì)管制、檢驗(yàn)與測試技術(shù)、含新儀器的開發(fā)； e) The identification of any measurement requirement involving capability that exceeds the known state of the art, in sufficient time for the needed capability to be developed. 鑑定任何量測需求其能力超出現(xiàn)有已知技術(shù)水準(zhǔn)者，應(yīng)有充裕的時(shí)間以開發(fā)所需的能力； f) The identification of suitable verification at appropriate stages in the realization of product。但也可採用能達(dá)成本項(xiàng)意圖的類似 技術(shù)。s special characteristic symbol (or the supplier39?？尚行允侵冈诩榷ǖ慕y(tǒng)計(jì)制程能力，產(chǎn)能且符合所有工程要求的前提下， 評(píng)定某特定產(chǎn)品其設(shè)計(jì)、材料或生產(chǎn)制程的適切性。s product. 供應(yīng)商的設(shè)計(jì)管制（ ）及制程管制（ ），其政策與實(shí)務(wù)應(yīng)考量關(guān)注產(chǎn)品的安全性。參考潛在失效模式與效應(yīng)分析參考手冊(cè)。 The Control Plan requirement enpasses processes producing bulk materials (. steel, plastic resin, paint) as well as those producing parts. 此項(xiàng)管制計(jì)劃要求含蓋生產(chǎn)散裝材料的制程（譬如：鋼鐵、 塑料 樹脂、油漆）及零組個(gè)生產(chǎn)。顧客如是 要求時(shí)， 供應(yīng)商應(yīng)有原型樣品管制計(jì)劃。供應(yīng)商應(yīng)運(yùn)用跨功能團(tuán)隊(duì)的方式以發(fā)展管制計(jì)劃。對(duì)於外部供應(yīng)商，也可包括顧客的採購、品質(zhì)、產(chǎn)品工程、顧客工廠人員和分包商的人員。 Production Part Approval Process 量產(chǎn)零組件核準(zhǔn)程序 General 概述 The supplier shall fully ply with all requirements set forth in the Production Part Approval Process (PPAP) manual. 供應(yīng)商應(yīng)完全符合量產(chǎn)零組件核準(zhǔn)程序（ PPAP）手冊(cè)裡規(guī)定的所有要求。 NOTE: This applies equally to suppliers and subcontractors. 備注：本項(xiàng)要求適用於供應(yīng)商與分包商。s anization. 備注：應(yīng)將持續(xù)改善的理念全面地展開到整個(gè)組織。對(duì)於那些隻能用計(jì)數(shù)值數(shù)據(jù)來評(píng)估的產(chǎn)品特性和制程參數(shù)，在特性不符合前，持續(xù)改善是不可能的。 NOTE: Examples of situations which might lead to improvement projects are: 備注： 可能導(dǎo)致改善專案的情況其例如下： Unscheduled machine downtime 非計(jì)劃排定的停機(jī)時(shí)間 Machine setup, die change and machine changeover times 機(jī)器設(shè)定換模及換機(jī)時(shí)間 Exces。 The supplier shall develop a prioritized action plan for continuous improvement in processes that have demonstrated stability, acceptable capability and performance. 制程一旦顯示相當(dāng)穩(wěn)定且制程能力合乎要求時(shí)，供應(yīng)商應(yīng)研擬具體優(yōu)先的持續(xù)改善計(jì)劃。 NOTE: Cost elements or price should be one of the key indicators within a continuous improvement system. 備注：成本因素或價(jià)格需是持續(xù)改善系統(tǒng)中的重要指標(biāo)之一。本項(xiàng)要求並不取代創(chuàng)新改進(jìn)的需 要。 Engineering Change Validation 工程變更的確認(rèn) The supplier shall verify that changes are properly validated. Sec 4. 12, and PPAP. 供應(yīng)商負(fù)責(zé)驗(yàn)証工程變更被適當(dāng)?shù)拇_認(rèn)。 the following occur: 當(dāng)下列任何一項(xiàng)情況發(fā)生時(shí)，管制計(jì)劃應(yīng)進(jìn)行適當(dāng)?shù)貦z討和更新： The product is changed. 產(chǎn)品變更時(shí) The processes are changed. 制程變更時(shí) The processes bee unstable. 制程不穩(wěn)定時(shí) The processes bee noncapable. 制程能力不足 時(shí) Inspection method, frequency, etc. is revised. 檢驗(yàn)方法，頻度等被變更。s design, manufacturing, engineering, quality, production, and other appropriate personnel. For external suppliers, it may include the customer39。 量產(chǎn)前 說明介於原型樣品和全面量產(chǎn)之間，所發(fā)生的各項(xiàng)尺寸量測、材料及性能測試等。當(dāng)產(chǎn)品或制程顯著不同於現(xiàn)行量產(chǎn)時(shí)，則管計(jì)劃應(yīng)加以修訂或更新。 The Control Plan 管制計(jì)劃 The supplier shall develop Control Plan at the system, subsystem, ponent and/or material level, as appropriate for the product supplied. 供應(yīng)商應(yīng)對(duì)所 供應(yīng)產(chǎn)品的系統(tǒng)、子系統(tǒng)、組件及（或）物料等各層次適當(dāng)?shù)闹贫ü苤朴?jì)劃。 Process Failure Mode and Effects Analysis (Process FMEAs) 制程的失效模式與效應(yīng)分析 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 am approval requirements that shall be met prior to production part approval (see Section II). Refer to the Potential Failure Mode and Effect Analysis reference manual. 制程的失效模式與效應(yīng)分析應(yīng)考慮所有的管制特性，應(yīng)致力於改善制程，以做到預(yù)防不良勝於找出不良。 Product Safety 產(chǎn)品安全性 Due care and product safety shall be considered in the supplier39。管制特性可能來自任何產(chǎn)品特性的種類，即尺企業(yè) ()大量管理資料下載 Page : 12 / 46 寸、材質(zhì)、外觀、功能。 Special Characteristics 管制特性 The supplier39。 釐清 所有性能與要求的允收標(biāo)準(zhǔn)，包括那些具主觀因素者； h) The identification and preparation of quality records (see ) 品質(zhì)記錄之鑑別與調(diào)制（參閱 ） Advanced Product Quality Planning 先期產(chǎn)品品質(zhì)規(guī)劃 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. 供應(yīng)商應(yīng)建立和實(shí)施先期產(chǎn)品品質(zhì)規(guī)劃流程。s method of operation. The supplier shall give consideration to the following activities, as appropriate, in meeting the specified requ