【正文】 cturer (原始設(shè)計製造商 ) 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。 ? 據(jù)聞過去有些認(rèn)証公司 (Registrars) “鼓勵 ‖有「 設(shè)計責(zé)任 」或「有從事產(chǎn)品設(shè)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(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 ) ? 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(yùn)作在於它需鑑別及管理眾多之「環(huán)環(huán)相扣之活動」。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?？赡苤繙y指標(biāo)有 : capability, (製程能力 , . Cpk) reaction time, (反應(yīng) /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(guān)鍵。 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(qiáng)調(diào) Efficiency ―效率” 以達(dá)到 Interested Parties ―利害關(guān)係者” 之滿意 : 含客戶 , 員工 , 股東 /投資者 , 供應(yīng)商 /夥伴 , 社區(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」 , 因為 68 f The anization shall implement actions necessary。既然某一缺乏量測資料 (missing measurements) 之“關(guān)鍵績效量度指標(biāo)” (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(biāo) , 組織應(yīng)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(jìn)式的持續(xù)改善 ,或 突破式的流程 /企業(yè)再造工程 )。 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(qiáng)調(diào) “ Plan‖ 和 “ Act‖, 此兩項是 多數(shù)公司較弱之地方。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(xí)於保留「設(shè)計記錄」。 iv) 雖然 「 原始設(shè)計」不屬於某一組織，但該組織可能有 「 責(zé)任」及 「 權(quán)力」來變更產(chǎn)品規(guī)格或特性。在挑戰(zhàn) ISO 9001:2023 Upgrade時，因 A廠本身確實有從事此種產(chǎn)品之 設(shè)計與開發(fā)活動，而且此種活動確實也會影響其符合客戶要求之能力 (the activity does affect its ability to meet customer requirements)， 因此 A廠決定不將 (Design and Development) 排除在 QMS之外。 ? Exclusion (排外 ) of ISO 9001:2023 requirements ―Not Applicable‖ due to the nature of an anization and its product: 由於組織及其產(chǎn)品之「性質(zhì) 」 (nature) 不同之關(guān)係，可能新的 ISO 9001:2023標(biāo)準(zhǔn)有某些條文可以不適用，那麼這些不適用之情況可以被考慮當(dāng)成「排外 」 (exclusion)。 TS 16949:2023 NOTE The knowledge and use of the eight quality management principles referred to in ISO 9000:2023 and ISO 9004:2023 should be demonstrated and cascaded through the anization by top management. 備註 八項品質(zhì)管理原則（參考 ISO 9000:2023和 ISO 9004:2023） 的知識和應(yīng)用，應(yīng)由高階管理階層加以示範(fàn)並由上而下展開至整個組織。組織進(jìn)行「 e化 /M化」必會導(dǎo)致「作業(yè)流程」 ，