【正文】 ent 識(shí)別關(guān)鍵過(guò)程設(shè)備 ? Develop total preventive maintenance system 制定全面預(yù)防維護(hù)體系 Documented procedure 文件化的程序 Scheduled maintenance activities 定期維修活動(dòng) Predictive maintenance methods 預(yù)知 /預(yù)計(jì)的維修方法 + Packaging, preservation of equip. tooling and gaging 設(shè)備、工裝和檢具包裝防護(hù) Replacement parts availability 關(guān)鍵設(shè)備可替換零件 + Documenting, evaluating and improving objectives 文件化、評(píng)估和改進(jìn)維護(hù)目標(biāo) 53 QS 9000 53 3/15/2023 QS9000 Section I 第一部分 Prescriptive Interpretations of ISO 9001 ISO 9001 規(guī)定的要求 Process Monitoring and Operator Instructions 過(guò)程監(jiān)控 /作業(yè)者指導(dǎo)書(shū) ? Documented Instructions 文件化的程序 ? For all employees 對(duì)所有操作人員 ? Accessible at work stations 在工作站易於取得 ? From the sources listed in APQP 來(lái)源于 APQP ? Various forms and formats 各種表單和格式 ? Include or reference contents 包括或參考內(nèi)容 About 13 items 計(jì) 13項(xiàng) 54 QS 9000 54 3/15/2023 QS9000 Section I 第一部分 Prescriptive Interpretations of ISO 9001 ISO 9001 規(guī)定的要求 + Maintaining Process Control 初期制程能力要求 ? Maintain process capability via PPAP 保持 PPAP規(guī)定過(guò)程能力 ? Implement Control Plan 保證控制計(jì)劃的執(zhí)行 Measurement technique 測(cè)量技術(shù) Sampling plans 抽樣方案 Acceptance criteria 接收標(biāo)準(zhǔn) Reaction plan 反應(yīng)計(jì)劃 ? Big event note on control chart 顯著過(guò)程事件反映在控制圖上 ? May revise Control Plan if high capability 能力過(guò)高可控制計(jì)劃 ? Reaction plan if the characteristics are unstable or noncapable特性不穩(wěn)定或不可接受時(shí)，制定反映計(jì)劃 55 QS 9000 55 3/15/2023 QS9000 Section I 第一部分 Prescriptive Interpretations of ISO 9001 ISO 9001 規(guī)定的要求 Modified Process Control Requirements 過(guò)程控制要求的修改 – Control plan annotated if different requirements required by client 如顧客要求不同于控制計(jì)劃，在控制計(jì)劃中注釋出來(lái) Verification of Job Setups 作業(yè)準(zhǔn)備的驗(yàn)證 – Verified whenever a setup is performed 確定后需驗(yàn)證 – Job instructions is available for setup person 應(yīng)有指導(dǎo)書(shū) – Lastoff part parison remended 建議進(jìn)行末件部件比較 – Statistical verification when applicable 如需要可進(jìn)行統(tǒng)計(jì)性驗(yàn)證 + Process Changes 過(guò)程更改 – Maintain records of process change effective dates 保存過(guò)程更改生效日期記錄 56 QS 9000 56 3/15/2023 QS9000 Section I 第一部分 Prescriptive Interpretations of ISO 9001 ISO 9001 規(guī)定的要求 Appearance Items 外觀項(xiàng)目 ? For appearance items, Supplier shall have : 對(duì)指定外觀件，供應(yīng)商應(yīng)： Appropriate lighting, 合適的照明 Master s for gloss, metallic brilliance, distinctness of image 光亮、金屬色澤、影象差異標(biāo)準(zhǔn)件 Maintenance of masters and equipment 標(biāo)樣和評(píng)定用設(shè)備的維護(hù) Qualified verification personnel 已驗(yàn)證合格的驗(yàn)證人員 57 QS 9000 57 3/15/2023 QS9000 Section I 第一部分 Prescriptive Interpretations of ISO 9001 ISO 9001 規(guī)定的要求 ? Inspection and Testing 檢驗(yàn)和試驗(yàn) ? General 總則 4 . Acceptance Criteria 計(jì)數(shù)數(shù)據(jù)接收標(biāo)準(zhǔn) – Zero defect for attribute data sampling plans 對(duì)計(jì)數(shù)型數(shù)據(jù) , 采用零缺陷的抽樣計(jì)劃 – All other situations documented by supplier and approved by customer 其它情形供應(yīng)商需開(kāi)成文件 ,并需經(jīng)顧客批準(zhǔn) ? Receiving Inspection and Testing 進(jìn)貨檢驗(yàn)和試驗(yàn) + Ining Product Quality 進(jìn)貨產(chǎn)品的質(zhì)量 – Receipt and evaluation of statistical data 統(tǒng)計(jì)數(shù)據(jù)記錄單和評(píng)估 – Receiving inspection test 進(jìn)貨檢驗(yàn)和試驗(yàn) – 2nd. or 3rd. party audits of subcontractor sites 第二、三方審核 – Part evaluation by accredited lab. 認(rèn)可試驗(yàn)室進(jìn)行的零件評(píng)價(jià) 58 QS 9000 58 3/15/2023 ? Inprocess Inspection and Testing 過(guò)程檢驗(yàn)和試驗(yàn) ? Final Inspection Testing 最終檢驗(yàn)和試驗(yàn) 4 . Layout Inspection and Functional Testing 全尺寸檢驗(yàn)及功能試驗(yàn) – For all products at a frequency 對(duì)所有產(chǎn)品以一定的頻次 – Results is available for customer review 可供顧客評(píng)定 + Final Product Audit 最終產(chǎn)品審核 – For packaged final product at an appropriate frequency 對(duì)包裝后最終產(chǎn)品 ,適當(dāng)?shù)念l次 – Verify conformance to all specified requirements 驗(yàn)證符合全部要求 ? Final Inspection Testing 最終檢驗(yàn)和試驗(yàn) QS9000 Section I 第一部分 Prescriptive Interpretations of ISO 9001 ISO 9001 規(guī)定的要求 59 QS 9000 59 3/15/2023 + Supplier Laboratory Requirements 供方試驗(yàn)室要求 + Laboratory Quality System 試驗(yàn)室質(zhì)量體系 – Laboratory scope 要有試驗(yàn)室業(yè)務(wù)范圍 – Documented all polices, system, programs, procedures, findings. 文件化體系 + Laboratory Personnel 試驗(yàn)室人員 – Have appropriate background and experience 要有適當(dāng)?shù)慕?jīng)歷和經(jīng)驗(yàn) + Laboratory Product Identification and Testing 試驗(yàn)室產(chǎn)品標(biāo)識(shí)及試驗(yàn) ? Have procedure for test samples and calibration equipment ? 對(duì)樣品和校驗(yàn)設(shè)備接收、搬運(yùn)、防護(hù)和處理期限要有程序 ? Retain and enable traceability 保存并保證追溯性 QS9000 Section I 第一部分 Prescriptive Interpretations of ISO 9001 ISO 9001 規(guī)定的要求 60 QS 9000 60 3/15/2023 + Laboratory Process Control 試驗(yàn)室過(guò)程控制 – Monitor, control and record environmental condition 監(jiān)視、控制和記錄環(huán)境狀況 + Laboratory Testing and calibration Method 試驗(yàn)室試驗(yàn)和校驗(yàn)方法 – Use test/calibration method which meet needs of client/standards 使用滿足顧客或標(biāo)準(zhǔn)要求的方法 – Verify the capability 確認(rèn)按標(biāo)準(zhǔn)執(zhí)行的能力 – Agree with client if no standard specification 無(wú)標(biāo)準(zhǔn)規(guī)定需協(xié)商 + Laboratory Statistical Methods 試驗(yàn)室統(tǒng)計(jì)方法 – Apply to verification activities whose deliverable are data 對(duì)于輸出是數(shù)據(jù)驗(yàn)證活動(dòng)可使用統(tǒng)計(jì)技術(shù) + Accredited Laboratories 認(rèn)可試驗(yàn)室 ? Use accredited laboratory 使用認(rèn)可試驗(yàn)室 QS9000 Section I 第一部分 Prescriptive Interpretations of ISO 9001 ISO 9001 規(guī)定的要求 61 QS 9000 61 3/15/2023 QS9000 Section I 第一部分 Prescriptive Interpretations of ISO 9001 ISO 9001 規(guī)定的要求 ? Control of I, MT Equipment 檢驗(yàn) , 測(cè)量和試驗(yàn) (IMT)設(shè)備控制 ? general 總則 ? Control Procedure 控制程序 + Calibration Services 校準(zhǔn)服務(wù) ? By qualifi