【正文】 區(qū)團(tuán)體 … 等 .) 67 ?B) 「 四部曲」 /ISO 9001:2023, Clause — 1) A process/plan/method/approach? 2) Implemented? 3) Effective/achievement of planned/desired results (oute)? 4) Continual improvement? 指第一部曲之 process 之持續(xù)改善 , . 「 簡化流程」 , 因?yàn)? 68 f The。 而 美式的過程管理 則強(qiáng)調(diào) 溝通 ，亦即將要完成的事情透過充分的溝通，讓下一階段執(zhí)行任務(wù)的人充分掌握，然後盡全力完成，最後所追求的結(jié)果也會呈現(xiàn)，而 過程管理 強(qiáng)調(diào)將整個(gè)任務(wù)以各階段必要 輸出 的完成，作為下一階段執(zhí)行的 輸入 ，一旦能 確保各階段 輸出 與 輸入 以系統(tǒng)化的完整處理 ，自可確保整個(gè)任務(wù)的有效達(dá)成?？赡苤繙y指標(biāo)有 : capability, (製程能力 , . Cpk) reaction time, (反應(yīng) /回覆時(shí)間 ) cycle time or throughput . 製造週期效能 (manufacturing cycle effectiveness, MCE)= 加工時(shí)間 (Processing Time) 產(chǎn)出時(shí)間 (Throughput Time) measurable aspects of dependability, (可靠度 ) yield, (良率 ) Firstpass yields (第一次成功率 ) 62 the effectiveness and efficiency of the anization’s people, (人員之績效 ) utilization of technologies, (科技之使用率 ) waste reduction, and (減廢 ) cost allocation and reduction. (降低成本 ) Determine Process Effectiveness ISO 9000:2023 defines effectiveness as “Extent to which planned activities are realized and planned results achieved” 63 In determining process effectiveness, the assessor should verify that the processes of the QMS result in: Results of (specific) process audit Internal Audit Results Financial measures ( failure costs.) Selfassessment (不同於 internal audit) Achievement of the quality policy and objectives (departmental/sectional goals) Achievement of planned arrangements Achievement of customer satisfaction (含 Internal Customer:下一工站之 user: those receiving the output of the process) Achievement of continual improvement 64 ?其實(shí)，從 ISO 9001:1994開始， UL一直都是以process approach在執(zhí)行 audit (例如 APQP或Quality Planning) ?觀念 : 品質(zhì)看得見，「過程」是關(guān)鍵。 59 意即 :「 If you can’ t measure it, you can’ t manage it ! (如果你不能衡量它，就無法管理它 !) 」。這些方法必須能展示這些流程能達(dá)成既定 /預(yù)期之結(jié)果。 47 ? An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as their bination and interaction. 「流程導(dǎo)向」其中一個(gè)好處是 , 它能針對「流程系統(tǒng)內(nèi)的各個(gè)流程之間之 連結(jié) , 組合 以及 交互作用 提供 持續(xù)性之控管 」 。 ? 據(jù)聞過去有些認(rèn)証公司 (Registrars) “鼓勵(lì) ” 有「 設(shè)計(jì)責(zé)任 」或「有從事產(chǎn)品設(shè)計(jì)與開發(fā)」之公司去申請ISO 9002？！ ? Applicable design interfaces to be assessed at plant level →OEM vs. Remote Design Center 之情況 Remarks: “ Assessing interfaces” starts with determining responsibilities and the munication channels between the locations. Assess the inputs/outputs using the process approach. 45 ?Activities (Steps) vs. Process (流程 ) vs. Process Approach (流程導(dǎo)向 /方式 )觀念 : ? 3 puts : Input Throughput「 生產(chǎn) /Activities」 Output ? Set of interrelated or interacting ACTIVITIES (steps) which transforms inputs into outputs. (將 輸入 轉(zhuǎn)換成 輸出 之交互作用之活動(dòng) ) ? A PROCESS is any set of associated ACTIVITIES (steps) having inputs and generating outputs. (具有 輸入 , 並且能產(chǎn)生 輸出 之任何交互作用之活動(dòng)稱為一個(gè) “流程”「 process」 ) 46 ? For an anization to function effectively and efficiently, it has to identify and manage numerous linked activities. An activity using resources, and managed in order to enable the transformation of inputs into outputs, is considered as a process. Often the output from one process directly forms the input to the next. (一個(gè)組織之有效運(yùn)作在於它需鑑別及管理眾多之「環(huán)環(huán)相扣之活動(dòng)」。 註 :(常見錯(cuò)誤 )誤將工業(yè)標(biāo)準(zhǔn) /規(guī)格，安規(guī) /法規(guī)規(guī)定，客戶招標(biāo)規(guī)定當(dāng)成 Product specifications (design output)。 . OEM: Original Equipment Manufacturer (原始設(shè)備製造商 ) ODM: Original Design Manufacturer (原始設(shè)計(jì)製造商 ) EMS: Electronics Manufacturing Service (電子製造服務(wù) /電子代工業(yè) ): 臺灣已是全球之佼 佼者。 Product Spec. (產(chǎn)品規(guī)格 ) vs. Process Spec. (製程規(guī)格 ) . 電鍍廠 /車體塗裝烤漆廠之認(rèn)証範(fàn)圍 “ The (design and) provision of electroplating (或 painting)” ISO/TS 16949:2023 The only permitted exclusions for this Technical Specification relate to where the anization is not responsible for product design and development. Permitted exclusions do not include manufacturing process design. (製程設(shè)計(jì)不可以被排外 ) 36 附註 : i) 傳統(tǒng)之「設(shè)計(jì)與開發(fā) 」 (design and development) 是針對有形之「產(chǎn)品 」 (product)， 但亦適用於服務(wù) service (無形之產(chǎn)品 )。換言之，條文 (設(shè)計(jì)與開發(fā) ) 不可以排外。 Regulatory/Customer Permission to exclude applicable requirements not valid justification.: 「 法規(guī) 或 客戶 允許可以將某些 該適用 之條文 排外 」 並非有效之「排外」理由。 Customer Property 「客戶財(cái)產(chǎn)」 ?假如客戶提供「原始設(shè)計(jì)」給工廠製造，此即構(gòu)成所謂的「智慧財(cái)產(chǎn)」 (IP: Intellectual Property) 而算是「客戶財(cái)產(chǎn)」，必需納入組織之 QMS之中。 Remarks: 許多通過 ISO 9001:1994之公司之 QMS常被詬病為「由 20個(gè)不怎麼相關(guān)之活動(dòng)之鬆散結(jié)合，而不是緊密環(huán)環(huán)相扣之系統(tǒng)性結(jié)合 /管理」 (many ISO 9001:1994 pliant systems were actually a loose collection of 20 semirelated activities rather than a systematic approach to management.)。因?yàn)檫@些公司一開始就都很專注於 「 流程導(dǎo)向 /方式」 「 持續(xù)改善」， 「 高階管理階層參與」，有很好之 process來瞭解 「 客戶需求」及有效監(jiān)控及量測是否符合 「 客戶需求」，甚至將其結(jié)合至有效之 「 品質(zhì)目標(biāo)」及 「 客戶滿意度」管理 …. 。 23 8. Mutually beneficial supplier relationships (互利之中衛(wèi)體系關(guān)係 ): 打破「外牆」 ! Not strongly incorporated in ISO 9001:2023, but in ISO 9004:2023. 但可以延伸看成 interdepartments/internal customers之關(guān)係 : breaking the barriers between departments.(打破「內(nèi)牆」 !) . 英航 將外包作業(yè)發(fā)揮的淋漓盡致； 「企業(yè)合併」是為了達(dá)到預(yù)期之「綜效」 (Synergy): 1+1 ? 2 ? What if 內(nèi)鬥 /內(nèi)耗，勾心鬥角而形成「空轉(zhuǎn)」 …? ( a story: … interviewee 反問 interviewer:「 你要多少 ?」結(jié)果他被錄取了 !) 以上八大原則構(gòu)成 ISO 9000系列標(biāo)準(zhǔn)之基礎(chǔ)。 3. Clause Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction. 19 Remarks: 並不表示 Top Mgm’ t需要親自參與「合約 /訂單審查」。 14 註 : Procedure (ISO 9000:2023 ) Specified way to carry out an activity or a process NOTE 1 procedures can be documented or not. NOTE 2 When a procedure is documented, the term ―written procedure‖ or ―documented procedure‖ is frequently used. The document that contains a procedure can be called