【文章內(nèi)容簡(jiǎn)介】 技巧與訓(xùn)練等因素而定。備注7：書面程序可參考對(duì)應(yīng)那些界定作業(yè)如何執(zhí)行的工作指導(dǎo)書。品質(zhì)規(guī)劃 供貨商應(yīng)界定與書面化各項(xiàng)品質(zhì)要求是如何違成。品質(zhì)規(guī)劃應(yīng)與供貨商品質(zhì)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(yīng)適當(dāng)考量下列活動(dòng)以達(dá)成產(chǎn)品、項(xiàng)目或合約的規(guī)定要求：a. 擬定各項(xiàng)品質(zhì)計(jì)劃；b. 鑒定與取得為違成需求品質(zhì)所需之任何管制、流程、設(shè)備(含檢驗(yàn)及測(cè)試設(shè)備)、治具、資源及技術(shù)；c. 確保設(shè)計(jì)、生產(chǎn)流程、安裝、服務(wù)、檢驗(yàn)與測(cè)試等程序，與適用文件間彼此之一致性；d. 必要時(shí)，得更新質(zhì)量管理、檢驗(yàn)與測(cè)試技術(shù)，含新儀器的開發(fā)；e. 鑒定任何量測(cè)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)間開發(fā)所需能力；f. 在產(chǎn)品實(shí)現(xiàn)的各適當(dāng)階段鑒定其適切的驗(yàn)證；g. 厘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 )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： 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(jì)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盏姆绞奖硎?。先期產(chǎn)品品質(zhì)規(guī)劃 – 供貨商應(yīng)建立和實(shí)施先期產(chǎn)品品質(zhì)規(guī)劃流程。供貨商須召集內(nèi)部的跨功能小組，以準(zhǔn)備新產(chǎn)品或變更產(chǎn)品的量產(chǎn)。這些小組須采用規(guī)定在先期產(chǎn)品品質(zhì)規(guī)劃和管制計(jì)劃參考手冊(cè)的各種適當(dāng)?shù)募夹g(shù)。但也可采用能達(dá)成本項(xiàng)意圖的類似技術(shù)。小組的工作須包括：／定案(見(jiàn)附錄C)。管制特性 – 當(dāng)顧客的設(shè)計(jì)記錄(參閱詞匯)有標(biāo)明管制特性時(shí)，供貨商的各項(xiàng)制程管制指導(dǎo)書及類似的檔(FMEA、管制計(jì)劃，操作說(shuō)明)，使用顧客指定的管制特性符號(hào)(或者供貨商對(duì)等的符號(hào)或標(biāo)記)來(lái)標(biāo)明那些會(huì)影響管制特制的制程步驟(參見(jiàn)附錄C)。備注：初期時(shí)，顧客可能會(huì)確定管制特性并加以標(biāo)識(shí)。管制特性可能來(lái)自任何產(chǎn)品特性的種類，即尺寸、材質(zhì)、外觀,功能?？尚詫彶?– 供貨商在簽定合約以生產(chǎn)產(chǎn)品之前，應(yīng)對(duì)所規(guī)劃的產(chǎn)品探討及確認(rèn)制造的可行性?？尚行允侵冈诩榷ǖ慕y(tǒng)計(jì)制程能能力，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)制程的迫切性?？尚行詫彶榻Y(jié)果的記載須使用先期產(chǎn)品品質(zhì)規(guī)劃和管制計(jì)劃參考手冊(cè)里的小組可行性承諾書。產(chǎn)品安全性 – 供貨商的設(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。供貨商需在內(nèi)部推廣對(duì)其產(chǎn)品安全性考量的認(rèn)知。Process Failure Mode and Effects Analysis (Process 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 Control Plan shall cover three distinct phases as appropriate：l Prototype – A description of the dimensional measurements and materialand performance tests that will occur during Prototype build (see APQP reference manual). The supplier shall have a prototype control plan if there are required by the customer.l Prelaunch – A description of the dimensional measurements and material and performance tests that will occur Prototype and before full Production.l Production – Documentation of product/process characteristics, process controls, tests, and measurement systems that occur during mass production. The supplier shall use a multidisciplinary approach to develop Control Plans.NOTE：A multidisciplinary approach typically includes the supplier’s Design, manufacturing, engineering, quality, production, and other Appropriate personnel. For external suppliers, it may include the customer’s Purchasing, quality, Engineering customer plant personnel as well as subcontractors.Control Plans shall be reviewed and updated as appropriate when any of thefollowing occur：l The product is changed. l The processes are changed. l The pro