【正文】 ent 識別關(guān)鍵過程設(shè)備 ? Develop total preventive maintenance system 制定全面預(yù)防維護體系 Documented procedure 文件化的程序 Scheduled maintenance activities 定期維修活動 Predictive maintenance methods 預(yù)知 /預(yù)計的維修方法 + Packaging, preservation of equip. tooling and gaging 設(shè)備、工裝和檢具包裝防護 Replacement parts availability 關(guān)鍵設(shè)備可替換零件 + Documenting, evaluating and improving objectives 文件化、評估和改進維護目標(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 過程監(jiān)控 /作業(yè)者指導(dǎo)書 ? Documented Instructions 文件化的程序 ? For all employees 對所有操作人員 ? 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 13項 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)定過程能力 ? Implement Control Plan 保證控制計劃的執(zhí)行 Measurement technique 測量技術(shù) Sampling plans 抽樣方案 Acceptance criteria 接收標(biāo)準(zhǔn) Reaction plan 反應(yīng)計劃 ? Big event note on control chart 顯著過程事件反映在控制圖上 ? May revise Control Plan if high capability 能力過高可控制計劃 ? Reaction plan if the characteristics are unstable or noncapable特性不穩(wěn)定或不可接受時，制定反映計劃 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劃，在控制計劃中注釋出來 Verification of Job Setups 作業(yè)準(zhǔn)備的驗證 – Verified whenever a setup is performed 確定后需驗證 – Job instructions is available for setup person 應(yīng)有指導(dǎo)書 – Lastoff part parison remended 建議進行末件部件比較 – Statistical verification when applicable 如需要可進行統(tǒng)計性驗證 + Process Changes 過程更改 – Maintain records of process change effective dates 保存過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 外觀項目 ? For appearance items, Supplier shall have : 對指定外觀件，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)樣和評定用設(shè)備的維護 Qualified verification personnel 已驗證合格的驗證人員 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 檢驗和試驗 ? General 總則 4 . Acceptance Criteria 計數(shù)數(shù)據(jù)接收標(biāo)準(zhǔn) – Zero defect for attribute data sampling plans 對計數(shù)型數(shù)據(jù) , 采用零缺陷的抽樣計劃 – All other situations documented by supplier and approved by customer 其它情形供應(yīng)商需開成文件 ,并需經(jīng)顧客批準(zhǔn) ? Receiving Inspection and Testing 進貨檢驗和試驗 + Ining Product Quality 進貨產(chǎn)品的質(zhì)量 – Receipt and evaluation of statistical data 統(tǒng)計數(shù)據(jù)記錄單和評估 – Receiving inspection test 進貨檢驗和試驗 – 2nd. or 3rd. party audits of subcontractor sites 第二、三方審核 – Part evaluation by accredited lab. 認(rèn)可試驗室進行的零件評價 58 QS 9000 58 3/15/2023 ? Inprocess Inspection and Testing 過程檢驗和試驗 ? Final Inspection Testing 最終檢驗和試驗 4 . Layout Inspection and Functional Testing 全尺寸檢驗及功能試驗 – For all products at a frequency 對所有產(chǎn)品以一定的頻次 – Results is available for customer review 可供顧客評定 + Final Product Audit 最終產(chǎn)品審核 – For packaged final product at an appropriate frequency 對包裝后最終產(chǎn)品 ,適當(dāng)?shù)念l次 – Verify conformance to all specified requirements 驗證符合全部要求 ? Final Inspection Testing 最終檢驗和試驗 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 供方試驗室要求 + Laboratory Quality System 試驗室質(zhì)量體系 – Laboratory scope 要有試驗室業(yè)務(wù)范圍 – Documented all polices, system, programs, procedures, findings. 文件化體系 + Laboratory Personnel 試驗室人員 – Have appropriate background and experience 要有適當(dāng)?shù)慕?jīng)歷和經(jīng)驗 + Laboratory Product Identification and Testing 試驗室產(chǎn)品標(biāo)識及試驗 ? Have procedure for test samples and calibration equipment ? 對樣品和校驗設(shè)備接收、搬運、防護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 試驗室過程控制 – Monitor, control and record environmental condition 監(jiān)視、控制和記錄環(huán)境狀況 + Laboratory Testing and calibration Method 試驗室試驗和校驗方法 – 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 無標(biāo)準(zhǔn)規(guī)定需協(xié)商 + Laboratory Statistical Methods 試驗室統(tǒng)計方法 – Apply to verification activities whose deliverable are data 對于輸出是數(shù)據(jù)驗證活動可使用統(tǒng)計技術(shù) + Accredited Laboratories 認(rèn)可試驗室 ? Use accredited laboratory 使用認(rèn)可試驗室 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 , 測量和試驗 (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