【正文】 II Customer Specific Requirements第二部分：顧客的特殊要求 ? Big3 and other OEMspecific Requirements 三大車(chē)廠及其他整車(chē)場(chǎng)各自的特殊要求21QS 9000 21 3/15/2023Structure of QS9000 2nd. Ed. QS9000的結(jié)構(gòu)的結(jié)構(gòu) (第二版第二版 )X Section I ISO 9001 Based 第一部分：基于 ISO 9001? ISO 9001 (1994) with automotiveprescriptive interpretationsISO 9001 (1994)加上汽車(chē)行業(yè)所規(guī)定的要求X Section II Automotive Sector 第二部分：汽車(chē)行業(yè)部分? Production Part Approval Process (PPAP) 生產(chǎn) 件 批準(zhǔn) 程 序 ? Continuous Improvement 持續(xù)改進(jìn)? Manufacturing Capability 制造能力X Section III Customer Specific 第三部分：顧客的特殊要求22QS 9000 22 3/15/2023 Note /說(shuō)明 SHALL mandatory requirements 強(qiáng)制要求SHOULD a preferred approach 推薦采用的方法，選用其它方法應(yīng)滿(mǎn)足 QS的要求 TYPICAL EXAMPLE the appropriate alternative for particular modity or process should be chosen 對(duì)特別的產(chǎn)品或過(guò)程應(yīng)采取的適宜方法NOTE for guidance 用于指導(dǎo)作用 + different from QS9000 2nd. Ed. different from ISO9001 與 QS9000第二版不同 與 ISO9001不同 23QS 9000 23 3/15/2023QS9000 : PrescriptiveInterpretations of ISO 9001ISO 9001規(guī)定的要求Section I Individual Element Requirements 第一部分 各個(gè)要素的要求24QS 9000 24 3/15/2023QS9000Section I 第一部分Prescriptive Interpretations of ISO 9001 ISO 9001 規(guī)定的要求X Management Responsibility 管理職責(zé)X Quality Police 質(zhì)量方針X Organization 組織X Responsibility and Authority 職責(zé)和權(quán)限 + f) Represent needs of customer in internal function 代表顧客需求X Resources 資源X Management Representative 管理者代表25QS 9000 25 3/15/2023QS9000Section I 第一部分Prescriptive Interpretations of ISO 9001 ISO 9001 規(guī)定的要求 Organizational Interfaces 組織接口? Ensure management of activities :確保下述階段活動(dòng)的管理During : concept development 概念策劃: prototype 樣品 /機(jī)生產(chǎn) : production 正式生產(chǎn)? Multidisciplinary decision making 多方 論 證 決 策 的 制 定 ? Customer prescribed format 顧客要求的形式? Typical functions 典型功能 (部門(mén) ) + Information to Management 通報(bào)管理層 ? Inform management of nonconforming product or process 出現(xiàn)不符合要迅速通報(bào)管理層26QS 9000 26 3/15/2023QS9000Section I 第一部分Prescriptive Interpretations of ISO 9001 ISO 9001 規(guī)定的要求X Management Review 管理評(píng)審 Management Review 管理評(píng)審? Include all element 要包括整個(gè)體系所有要素+Note: with a multidisciplinary approach 用多方論證方法 Business Plan 業(yè)務(wù)計(jì)劃? Control document 受控文件? 12 items may be included 可包括 12個(gè)方面? 12 and over 3 year goal 包括長(zhǎng)短期目標(biāo)? Based on analysis 以競(jìng)爭(zhēng)產(chǎn)品，業(yè)內(nèi)外廠家分析為基礎(chǔ)? Determine current future expectations 確定顧客希望? Document to track, update, revise review 規(guī)定方法27QS 9000 27 3/15/2023QS9000Section I 第一部分Prescriptive Interpretations of ISO 9001 ISO 9001 規(guī)定的要求 Analysis / Use of CompanyLevel Data 公司級(jí)資料的分析和利用? Document trends in : 把下列 Y果的走勢(shì)作出報(bào)告4 Quality 質(zhì)量4 Operational performance 作業(yè)表現(xiàn)4 Current quality levels 現(xiàn)行質(zhì)量水平 ? Compare with petitor or benchmarks 同競(jìng)爭(zhēng)對(duì)手比較? Compare with business objectives 同業(yè)務(wù)目標(biāo)比較+Lead to action to support 轉(zhuǎn)化成行動(dòng)以支持：4 Solve clientrelated problems 解決與顧客相關(guān)的問(wèn)題4 Support decisionmaking 支持決策28QS 9000 28 3/15/2023QS9000Section I 第一部分Prescriptive Interpretations of ISO 9001 ISO 9001 規(guī)定的要求 Customer Satisfaction 顧客滿(mǎn)意程度? Documented process 文件化的過(guò)程? Trends key indicators 記錄顧客不滿(mǎn)意的要因及滿(mǎn)意趨勢(shì) ? Compare with petitor or benchmark 同競(jìng)爭(zhēng)對(duì)手比較? Reviewed by senior management 高層管理者評(píng)審+ Registrar Notification 通知認(rèn)證機(jī)構(gòu)? Notify registrar in 5 days if: 顧客提出如下問(wèn)題， 5日內(nèi)通知4 Chrysler Need Improvement4 Ford Q1 Revocation4 GM Level 2 Containment 29QS 9000 29 3/15/2023QS9000Section I 第一部分Prescriptive Interpretations of ISO 9001 ISO 9001 規(guī)定的要求X Quality Systems 質(zhì)量體系X General 總則X Quality System Procedures 質(zhì)量體系程序X Quality Planning 質(zhì)量策劃+ APQP 產(chǎn)品先期質(zhì)量策劃 ? Establish and implement APQP 建立和執(zhí)行 APQP ? Convene multidisciplinary teams 召集多方論證小組 ? For production of new or changed product 針對(duì)新產(chǎn)品及更改產(chǎn)品? Develop./finalization of special characteristics 特殊特性開(kāi)發(fā)與確定? Develop. And review of FMEAs FMEA開(kāi)發(fā)與評(píng)審? Reduce potential failure modes with high risk number 減少風(fēng)險(xiǎn)大的模式? Develop. Or review of Control Plan 控制計(jì)劃的評(píng)審與制定30QS 9000 30 3/15/2023QS9000Section I 第一部分Prescriptive Interpretations of ISO 9001 ISO 9001 規(guī)定的要求+ Special Characteristics 特殊特性? If SCs are identified on client design record, related procedure documents of supplier marked with SC symbol 當(dāng)顧客設(shè)計(jì)記錄表明特殊特性時(shí)，供方過(guò)程控制指南及類(lèi)似文件應(yīng)將顧客特殊特性符號(hào)標(biāo)識(shí)出來(lái) Feasibility Review 可行性評(píng)審– Investigate and confirm manuf. feasibility prior to contracting 供方簽訂合同之前，應(yīng)分析確定制造該產(chǎn)品的可行性? Review should be documented 應(yīng)形成文件+ Product Safety 產(chǎn)品安全性? Consider in design control and process control police and practices 在供方設(shè)計(jì)和過(guò)程控制政策制定及實(shí)施過(guò)程中考慮安全性? Promote internal awareness 應(yīng)鼓勵(lì)內(nèi)部認(rèn)知31QS 9000 31 3/15/2023QS9000Section I 第一部分Prescriptive Interpretations of ISO 9001 ISO 9001 規(guī)定的要求 Process FMEAs 過(guò)程失效模式及后果分析– Consider all special characteristics 考慮所有特殊特性– Defect prevention rather than defect detect 缺陷預(yù)防不是找缺陷 – Meet prior to production part approval 在生產(chǎn)件批準(zhǔn)前滿(mǎn)足顧客 Mistake Proofing 防錯(cuò)方法? Utilize the methodologies during planning of process, tooling, etc. 在過(guò)程 設(shè)施 設(shè)備 工裝的策劃中，供方要利用適當(dāng)?shù)姆厘e(cuò)方法32QS 9000 32 3/15/2023QS9000Section I 第一部分Prescriptive Interpretations of ISO 9001 ISO 9001 規(guī)定的要求 The Control Plan 控制計(jì)劃? Develop the plan at system, subsystem, ponent or material level 包括系統(tǒng)、子系統(tǒng)、 部件和材料各層次? Control Plan form in Appendix J. 有表樣，見(jiàn)附錄 J? Enpasses bulk materials and parts 包括原材料和零件生產(chǎn)? Output of advanced quality planning process 是產(chǎn)品質(zhì)量先期策劃過(guò)程的結(jié)果? Cover three phases 包括三個(gè)階段：