【正文】 – Customer approval or waiver before production 在生產(chǎn)進行前需得到顧客的批準(zhǔn)或讓步接受– Proprietary design changes require customer review 所有專利性的設(shè)計 , 其變更需要顧客評審+ Design Change Impact 設(shè)計更改的影響? Consider the impact on product is used 考慮更改對在用產(chǎn)品的影響45QS 9000 45 3/15/2023QS9000Section I 第一部分Prescriptive Interpretations of ISO 9001 ISO 9001 規(guī)定的要求+ Customer Prototype Support 客戶樣機支援– Prototype program if required by customer 在顧客要求時，有樣機計劃– Use the same subcontractors, tooling processes 使用于生產(chǎn)相同的分供方、工裝和程序– Life, reliability and durability for performance test 型式試驗要包括適當(dāng)?shù)膲勖?、可靠和耐久性試驗– Track all performance testing activities 跟蹤型式試驗完成及符合情況+ Confidentiality 保密? Ensure the confidentiality 為顧客保密46QS 9000 46 3/15/2023QS9000Section I 第一部分Prescriptive Interpretations of ISO 9001 ISO 9001 規(guī)定的要求X Document and Data Control 文件和資料控制+ General 總則X Document and Data Approval and Issue 文件和資料的批準(zhǔn)和發(fā)布+ 11 kinds of documents 標(biāo)出 11種文件 Engineering Specifications工程規(guī)范– Timely Review, distribution and implement 定期審核、發(fā)放和執(zhí)行 – Record the date of implementation of production 生產(chǎn)實施日期記錄– Update all appropriate documents 更新所有相關(guān)文件v Document and Data Changes 文件和資料的更改47QS 9000 47 3/15/2023QS9000Section I 第一部分Prescriptive Interpretations of ISO 9001 ISO 9001 規(guī)定的要求X Purchasing采購X General 總則 Approval Materials for Ongoing Production 現(xiàn) 生產(chǎn)用材料的批準(zhǔn)– Use Customer list, or approved by customer 使用顧客提供的分供方名單 , 名單外分供方需經(jīng)顧客批準(zhǔn) Government, Safety and Environmental Regulation 政府、安全和環(huán)境規(guī)定– Satisfy health and safety regulations ie : restricted, hazardous, etc. 材料應(yīng)滿足健康和安全法規(guī) , 如 : 限用的 , 危險的v .2 Evaluation of Subcontractors 分供方評估48QS 9000 48 3/15/2023QS9000Section I 第一部分Prescriptive Interpretations of ISO 9001 ISO 9001 規(guī)定的要求 Subcontractor Development 分供方開發(fā)? Use Section 1of QS9000 使用 QS9000第一部分? Assessment at specified frequencies 依規(guī)定的頻次審核? Recognize 2nd 3rd party certification 承認第二、三方審核? Supplier is in charge of customerdesigned subcontractors 顧客選定分供方不免除供方的責(zé)任 Scheduling Subcontractors 分供方的交付計劃? 100% ontime delivery 100%準(zhǔn)時交付? Supplier to provide planning info. and purchase mitment 供應(yīng)商提供計劃信息和采購承諾? Monitor delivery performance/freight costs 監(jiān)控交付表現(xiàn) /運輸成本+ Purchasing Data 采購數(shù)據(jù) v Verification of Purchased Product 采購產(chǎn)品的驗證49QS 9000 49 3/15/2023QS9000Section I 第一部分Prescriptive Interpretations of ISO 9001 ISO 9001 規(guī)定的要求X Customer Supplied Product 顧客提供的產(chǎn)品 Includes : 包括– Customer owned tooling 顧客的工具– Returnable packaging 可回收的包裝物+ Customer Owned Tooling 屬于顧客的工裝 ? Permanently marked 永久性標(biāo)識50QS 9000 50 3/15/2023QS9000Section I 第一部分Prescriptive Interpretations of ISO 9001 ISO 9001 規(guī)定的要求X Identification Traceability 標(biāo)識和可追溯性 Note : 注釋 ? the words WHERE APPROPRIATE are not applicable 當(dāng)必要時 一詞不適用于 QS900051QS 9000 51 3/15/2023QS9000Section I 第一部分Prescriptive Interpretations of ISO 9001 ISO 9001 規(guī)定的要求X Process Control 制程控制+ Cleanliness of Premises 場地清潔– Maintain premises in a state of order, cleanliness and repair 保持場地處于有序、清潔和維護狀態(tài)+ Contingency Plans 應(yīng)急計劃– Prepare contingency plan to protect the supply in the event of emergency 準(zhǔn)備應(yīng)急計劃，以便在緊急情況下合理地保證產(chǎn)品交付 Designation of Special Characteristics 特殊特性的確定? Meet all requirements for designation,documentation and control of SCs 特殊特性的確定、文件化和控制要滿足顧客的所有要求? Documented evidence of pliance 需把符合要求的證據(jù) 文件化52QS 9000 52 3/15/2023QS9000Section I 第一部分Prescriptive Interpretations of ISO 9001 ISO 9001 規(guī)定的要求 Preventive Maintenance 預(yù)防性維護? Identify key process equipment 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) 53QS 9000 53 3/15/2023QS9000Section 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54QS 9000 54 3/15/2023QS9000Section 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55QS 9000 55 3/15/2023QS9000Section 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 i