【正文】 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 !) 」。 (. 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 improvement 5. TOP Management Processes Examples: ?Process to define quality policy and objectives ?Communication process ?Management review 6. Resource Management Processes Examples: ?Determination and provision of resources ?Human resources ?Infrastructure definition ?Work environment definition 7. Product Realization Processes Examples: ? Planning ?Customer related processes ?Design amp。 ? 據聞過去有些認証公司 (Registrars) “鼓勵 ‖有「 設計責任 」或「有從事產品設計與開發(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. 46 ?Activities (Steps) vs. Process (流程 ) vs. Process Approach (流程導向 /方式 )觀念 : ? 3 puts : Input Throughput「 生產 /Activities」 Output ? Set of interrelated or interacting ACTIVITIES (steps) which transforms inputs into outputs. (將 輸入 轉換成 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 , 並且能產生 輸出 之任何交互作用之活動稱為一個 “流程”「 process」 ) 47 ? 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」。 即使客戶核準 (認可 ) 了具有設計責任之供應商之產品 (a design responsible supplier’s product) 也不能免除該供應商之設計責任。 Customer/regulatory/product requirements:design input (客戶 /法規(guī) /產品要求 :設計輸入 ) vs. product characteristics/specifications:design output(產品特性 /規(guī)格 :設計輸出 ) 假如組織沒有被 (客戶 ) 提供 產品特性 (product characteristics) 或產品規(guī)格 (product specifications) 用以規(guī)劃其 產品實現過程 (product realization processes)， 並且組織必須根據 客戶或法規(guī)要求 (customer and/or regulatory body requirements) 來定義 (define) 這些產品特性 (或 product specifications)， 此意為「產品設計與開發(fā)」(product design and development) 。假使是委外給通過 Accredited ISO 9000之公司時 , Scope 之寫法可以寫成「 The design and manufacture of XXX (產品名稱 ) 」。 Remarks: 許多通過 ISO 9001:1994之公司之 QMS常被詬病為「由 20個不怎麼相關之活動之鬆散結合，而不是緊密環(huán)環(huán)相扣之系統(tǒng)性結合 /管理」 (many ISO 9001:1994 pliant systems were actually a loose collection of 20 semirelated activities rather than a systematic approach to management.)。 Involvement of people)是屬於 soft requirements (harder to audit!) * 21世紀強調「顧客第一，員工第二，服務第三，老闆最後」的領導觀念。重點是 Top Mgm’t要「確定」(ensure→ 可以 delegation「 授權」 )有一個process存在用以確定組織內之人員都知道「客戶需求」之重要性，並且要符合「客戶需求」 Customerrelated process Customer munication Customer satisfaction . 豐田汽車 及國外一些兒童玩具公司之「讓消費者全程參與商品開發(fā) —讓消費者成為研發(fā)團隊之“ Customerin‖概念」之落實。 Learning! . CAR, ECN, SWOT, FMEA, BSC… 9 ?為何有新版 ISO 9001:2022? 目的 ? ?應付 (更適合 )小公司 (Small Businesses) ? 「 小而美」 (ISO 9001: 1994不太適用小公司 ) ?更適合 「 各行各業(yè)」 (ISO 9001:1994 年版傾向於製造業(yè)之用 ) ?更簡單易懂 ? 1994年版 20個條文之問題 : 「 ISO 9001:1994→auditor friendly (easy to audit but difficult for .)」 vs.「 ISO 9001:2022 →anization friendly」 ? 和 ISO 14001 相容 ? 「品質管理系統(tǒng) 」 (QMS) 和「作業(yè)流程 」 (Business Processes) 相結合 : 「新版 ISO 9001 focuses on ―how to manage a business to achieve planned/desired results (. effectiveness), not on individual clauses‖ 」 vs. 「舊版 20個條文 : “ The supplier shall….‖ 」 10 ?更強調 「 持續(xù)改善 」 和 「客戶滿意 」 ?幾乎是向 QS9000 靠攏 ?強調高階管理階層之參與 (Emphasis on Top Management ): 條文 5 ?強調「一張証書涵蓋總公司 /旗下多廠 」 之認証模式 (Emphasis on Corporate