【正文】 66 ?A)「 三部曲」 /ISO 9001:1994, clause (1). Intent/Adequacy of Procedures 「 程序書之適合性 / “ 精神”或 “ 意涵” 」 ? (2). Implementation 「 執(zhí)行 or 落實 」 ? (3). Effectiveness 「 效果 」 ? (ISO 9004 : 2023 QMS—Guidelines for performance improvements更強調(diào) Efficiency “ 效率” 以達到 Interested Parties “ 利害關係者” 之滿意 : 含客戶 , 員工 , 股東 /投資者 , 供應商 /夥伴 , 社區(qū)團體 … 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」 , 因為 68 f The。 而 美式的過程管理 則強調(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 強調(diào)將整個任務以各階段必要 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 ，自可確保整個任務的有效達成。 過去習慣上我們會只問結(jié)果，不管它是如何達成的，因此我們可能投機取巧，留下甚多的後遺癥?？赡苤繙y指標有 : capability, (製程能力 , . Cpk) reaction time, (反應 /回覆時間 ) cycle time or throughput . 製造週期效能 (manufacturing cycle effectiveness, MCE)= 加工時間 (Processing Time) 產(chǎn)出時間 (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，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」是關鍵。既然某一缺乏量測資料 (missing measurements) 之“關鍵績效量度指標” (Key Measurable/KPI) 是組織之 senior management共同決議產(chǎn)生的，則組織必須建立一個新流程來產(chǎn)生這些 KPI’ s 所需要之 data， 千萬不可陷入錯誤的迷思 : 「 We can’ t measure what we want, so we have decided to want what we can measure!」 另 , GE Jack Welch名言 :「 What you measure is what you get — what you reward is what you get!」 60 Measurements should be used for managing daily operations, for evaluation of the processes that may be suitable for smallstep or ongoing continual improvements, as well as for breakthrough projects, according to the vision and strategic objectives of the anization. (根據(jù)所訂之願景和策略目標 , 組織應該使用 量測 來管理日常作業(yè) , 來評估流程 , 不管該流程是適合 逐步漸進式的持續(xù)改善 ,或 突破式的流程 /企業(yè)再造工程 )。 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 !) 」。 58 ? ISO 9004: 2023 Measurement and monitoring of processes (流程之量測與監(jiān)督 ) The anization should identify measurement methods and should perform measurements to evaluate process performance. The anization should incorporate these measurements into processes and use the measurements in process management. (組織應該鑑別量測方法 , 而且應該執(zhí)行量測 , 用以評估流程之績效。這些方法必須能展示這些流程能達成既定 /預期之結(jié)果。 49 PROCESS (“Set of interrelated or interacting activities”) INPUT OUTPUT MONITORING AND MEASUREMENT OPPORTUNITIES (Before, during and after the process) PRODUCT (―Result of a process‖) PROCEDURE (―Specified way to carry out an activity or a process‖ – may be documented or not) EFFECTIVENESS OF PROCESS = ABILITY TO ACHIEVE DESIRED RESULTS (Focus of ISO 9001:2023) EFFICIENCY OF PROCESS=Results acieved vs resources used (Focus of ISO 9004:2023) (Includes Resources) Focus of TS2: Effectiveness+Efficiency 50 ? PDCA/PDSA (PlanDoCheckAct 或 PlanDoStudyAct: 計劃 執(zhí)行 檢討 改善 ): Process approach 是遵循 PDCA管理 /改善循環(huán) : * Define the work (Plan 計劃 ) * Execute the work (Do 執(zhí)行 ) * Measure the results (Check 檢討 ) * Identify improvements (Act 改善 ): 含 CI , CA PA ISO 9001:2023 更強調(diào) “ Plan” 和 “ Act” , 此兩項是 多數(shù)公司較弱之地方。 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. 「流程導向」其中一個好處是 , 它能針對「流程系統(tǒng)內(nèi)的各個流程之間之 連結(jié) , 組合 以及 交互作用 提供 持續(xù)性之控管 」 。通常一個流程之 輸出 直接構(gòu)成了下一個流程之 輸入 。 ? 據(jù)聞過去有些認証公司 (Registrars) “鼓勵 ” 有「 設計責任 」或「有從事產(chǎn)品設計與開發(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 ) ? 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稱為一個 “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. (一個組織之有效運作在於它需鑑別及管理眾多之「環(huán)環(huán)相扣之活動」。經(jīng)驗告訴我們 , 一些傳統(tǒng)中小企業(yè)事實上有「開規(guī)格」生產(chǎn) , 但較不習於