【正文】 67 ?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 : 2022 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 .) 68 ?B) 「 四部曲」 /ISO 9001:2022, 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 69 f The anization shall implement actions necessary to achieve planned results (第三部曲 ) and continual improvement of these processes (第四部曲 )。 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。 Clauses 4, 5, 6 amp?？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 ) 63 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 9000:2022 defines effectiveness as “Extent to which planned activities are realized and planned results achieved” 64 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 65 ?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!」 61 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 )。 60 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 !) 」。 59 ? ISO 9004: 2022 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 /預期之結果。 service provision ?Control of monitoring and measuring devices (Fig 1) Quality Management System Processes 57 Correct Identify Core Processes (COP’s) Needs amp。 (. SPC/Control Charts, FMEA 等手法之使用 : ―Nice chart, but no action‖ ※ 或有“ s (statistics)‖， 沒有“ PC (Process Control)‖? Useless!) 52 Act ● How to improve Next time? Plan ● What to do ? ● (―Objective‖) ● How to do it? ● (―Procedure/method‖) Check ● Did things happen according to plan? Do ● Do what was planned “ The objective w/o method is useless‖ Better (Q) Cheaper (C) Faster (D) “ Monitor and measure processes and product against policies, objective and requirements for the product and report the results. Check: 53 PDCA vs. Process Approach/Interaction A C P D E X T E R N A L C U S T O M E R E X T E R N A L C U S T O M E R P A D C PROCESS A PROCESS B P A D C P A D C PROCESS C P A D C PROCESS E P A D C PROCESS D P A D C PROCESS F Internal Customer Internal Customer Feedback Output D Output E Input A Input B Output A Output B Input C Input F Output F Output C Input D Input E New process: 從 PDCA的 P開始轉 Existing process: 從 PDCA的 C開始轉 54 PROCESS CONTROL SYSTEM MODEL WITH FEEDBACK THE WAY WE WORK/ BLENDING OF RESOURCES STATISTICAL METHODS VOICE OF THE PROCESS ? MEN MACHINES MATERIALS METHODS ENVIRONMENT VOICE OF CUSTOMERS CUSTOMERS IDENTIFYING CHANGING NEEDS AND EXPECTATIONS ? INPUTS ? PROCESS/SYSTEM ? OUTPUTS 55 Pro cess Ap pr oa ch M od elP RO CE S SPR O DU CT RE ALI ZATI O NRE SO UR CE M AN AG EM EN TCUSTOMERCUSTOMERM AN AG EM EN T RE SPONSI BI LI TYM easur em ent ,Anal ysi s,i m pr ovem entSatisfactionPr od uc tO ut putIn putRequirementCon ti nu al Impr ov ement of the Q ualit yM anag ement S ys tem56 8. Measurement, Analysis and Improvement Processes Examples: ?Processes to demonstrate: ?Conformity of product ?Conformity of management system ?Continual impro