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General – The supplier shall establish and maintain documented procedures to control and verify the design of the product in order to ensure that the specified requirements are met. Use of Design Data – The supplier shall have a process to deploy information gained from Previous design projects to current and future projects of a similar nature.Design and Development Planning – The supplier shall prepare plans for each design and development activity. The plans shall describe or reference these activities, and define responsibility for their implementation. The design and development activities shall be assigned to qualified personnel equipped with adequate resources. The plans shall be updated, as the design evolves. Required Skills – The supplier’s design activity should be qualified in the following skills as appropriate:l Geometric dimensioning and tolerancing (GDamp。顧客對供貨商產(chǎn)品的核準,并不豁免供貨商的設(shè)計責(zé)任。設(shè)計管制 備注:本要項僅適用于供貨商負有設(shè)計責(zé)任者。記錄 合約審查的記錄應(yīng)予維持()。 d) 能夠違成顧客所有的要求,包括本文第2節(jié)的部份。備注:除非顧客特別規(guī)定,領(lǐng)應(yīng)商不需簽回采購訂單承認書。如果任何這方面的的工作系屬外包者,則需有一套追蹤和跟摧違些工作系統(tǒng)。 b) any difference between the contract or order requirements and those in the tender are resolved。Tooling Management – The supplier shall establish and implement a system for tooling management including:l Maintenance and repair facilities and personnel l Storage and recovery Setup l Tool change programs for perishable tools l Tool modification, including tool design documentationThe supplier shall provide appropriate technical resources for tool (see Glossary) and gage design, fabrication and full dimensional inspection. the supplier shall implement a system to track and followup on these activities if any of this work is subcontracted.NOTE:Tooling Management () is not required of warehouses or distributors.Contract Review – Element General – The supplier shall establish and maintain documented procedures for contract review and for the coordination of these activities.NOTE:The supplier is not requires to return signed Purchase Order Acknowledgements unless otherwise specified by the customer.Review – Before the submission of a tender, or the acceptance of a contract or order (statement of requirement), the tender, contract or order shall be reviewed by the supplier to ensure that :a) the requirements are adequately defined and documented。應(yīng)制定評估目前作業(yè)和制程有效性的方法,并考慮下列因素:總體工作計劃、適當(dāng)?shù)淖詣踊?、人體工學(xué)和人性因素、作業(yè)員和生產(chǎn)線的平衡、儲存和庫存量多寡及增值人工成份。持續(xù)改善的技術(shù) – 供貨商應(yīng)展示具有下列衡量和方法論的知識,并加以適當(dāng)應(yīng)用之:備注:以下所列為可能運用的各種技術(shù)例子,可能存有其它的方法更能貼切滿足供貨商的特定需要:1. 管制圖(計量值,計數(shù)值,累積總和圖)2. 實驗計劃法(DOE)3. 限制理論4. 設(shè)備綜合效益5. 零組件百萬分不良分析6. 價值分析7. 競爭標(biāo)竿8. 動作分析/人體工學(xué)9. 錯誤防止設(shè)施與工模具管理 設(shè)施、設(shè)備及制程規(guī)劃和效益 – 供貨商應(yīng)采用跨功能小組并結(jié)合先期品質(zhì)規(guī)劃流程的做法,以制定制程、設(shè)施及設(shè)備計劃。備注:制程能力不足或續(xù)效不佳時,需執(zhí)行矯正行動()品質(zhì)和生產(chǎn)力的改進 – 供貨商應(yīng)明確定出對品質(zhì)和生產(chǎn)力改進的機會,并報行適當(dāng)?shù)母倪M計劃。對于那些只能用計數(shù)值數(shù)據(jù)來評估的產(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,如果計數(shù)質(zhì)的結(jié)果不是零缺點時,則依定此為不合格產(chǎn)品(,)在此情況下,所謂改善意指矯正行動而非持續(xù)改善。備注:成本因赤或價格需是持續(xù)改善系統(tǒng)中的重要指針之一。備注:需將持續(xù)改善的理念全面地展開到整個組織。持續(xù)改善 – 概述 – 供貨商應(yīng)為所有的顧客持續(xù)不斷地改善品質(zhì)、服務(wù) (包括時效、交貨)及價格。工程變更的認認 – 供貨商負責(zé)驗證工程變更被適當(dāng)?shù)拇_認。分包商的要求 – 供貨商需對其分包商業(yè)(參閱詞匯)導(dǎo)入零零件核準程序。對于外部供貨商,也可包括顧客的采購、品質(zhì)、產(chǎn)品工程、顧客工廠人員和分包商的人員。供貨商應(yīng)運用跨功能團的方式以發(fā)展管制計劃。n 量產(chǎn)前─說明介于原型樣品和全面量產(chǎn)之間,所發(fā)生的各項尺寸量測、材料及性能測試等。管制計劃需列出制程管制()所使用的各項管制,管制計劃應(yīng)涵括下列三種不同階段:n 原型樣品─說明在原型樣品試制期間,所發(fā)生的各項尺寸量測、材料及性能測試等(參閱APQP參考手冊)。除了穩(wěn)健制程的開發(fā)以外,管制計劃亦是先期品質(zhì)規(guī)劃流程的結(jié)果。管制計劃包含附錄J管制計劃表格內(nèi)的所有信息(細項)。錯誤防止 – 供貨商應(yīng)于制程,設(shè)施,儀器,工模具等規(guī)劃過程中,使用適當(dāng)?shù)腻e誤防止方法論。某些顧客要求在產(chǎn)品認可核準前要先完成FMEA審查及核準(參閱雇客特定要求章節(jié))。供貨商需在內(nèi)部推廣對其產(chǎn)品安全性考量的認知。可行性審查結(jié)果的記載須使用先期產(chǎn)品品質(zhì)規(guī)劃和管制計劃參考手冊里的小組可行性承諾書??尚詫彶?– 供貨商在簽定合約以生產(chǎn)產(chǎn)品之前,應(yīng)對所規(guī)劃的產(chǎn)品探討及確認制造的可行性。備注:初期時,顧客可能會確定管制特性并加以標(biāo)識。但也可采用能達成本項意圖的類似技術(shù)。供貨商須召集內(nèi)部的跨功能小組,以準備新產(chǎn)品或變更產(chǎn)品的量產(chǎn)。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: l Development/finalization of special characteristics (see Appendix C)l Development and review of FMEAsl Establishment of actions to reduce the potential failure modes with high risk priority numbers l Development or review of Control PlansSpecial 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(zhì)記錄之鑒別與調(diào)制(參閱 )備注8:上述之品質(zhì)計劃成參閱 ()其形式可以構(gòu)成供貨商品質(zhì)系統(tǒng)之適當(dāng)書面程序?qū)φ盏?