【正文】 If you can’t measure it, you can’t manage it ! (如果你不能衡量它，就無(wú)法管理它 !) 」。 (. SPC/Control Charts, FMEA 等手法之使用 : ―Nice chart, but no action‖ ※ 或有“ s (statistics)‖， 沒(méi)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(kāi)始轉(zhuǎn) Existing process: 從 PDCA的 C開(kāi)始轉(zhuǎn) 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(jù)聞過(guò)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(kāi)發(fā)」之公司去申請(qǐng)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(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」 ) 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(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)」。 即使客戶核準(zhǔn) (認(rèn)可 ) 了具有設(shè)計(jì)責(zé)任之供應(yīng)商之產(chǎn)品 (a design responsible supplier’s product) 也不能免除該供應(yīng)商之設(shè)計(jì)責(zé)任。 Customer/regulatory/product requirements:design input (客戶 /法規(guī) /產(chǎn)品要求 :設(shè)計(jì)輸入 ) vs. product characteristics/specifications:design output(產(chǎn)品特性 /規(guī)格 :設(shè)計(jì)輸出 ) 假如組織沒(méi)有被 (客戶 ) 提供 產(chǎn)品特性 (product characteristics) 或產(chǎn)品規(guī)格 (product specifications) 用以規(guī)劃其 產(chǎn)品實(shí)現(xiàn)過(guò)程 (product realization processes)， 並且組織必須根據(jù) 客戶或法規(guī)要求 (customer and/or regulatory body requirements) 來(lái)定義 (define) 這些產(chǎn)品特性 (或 product specifications)， 此意為「產(chǎn)品設(shè)計(jì)與開(kāi)發(fā)」(product design and development) 。假使是委外給通過(guò) Accredited ISO 9000之公司時(shí) , Scope 之寫法可以寫成「 The design and manufacture of XXX (產(chǎn)品名稱 ) 」。 Remarks: 許多通過(guò) 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.)。 Involvement of people)是屬於 soft requirements (harder to audit!) * 21世紀(jì)強(qiáng)調(diào)「顧客第一，員工第二，服務(wù)第三，老闆最後」的領(lǐng)導(dǎo)觀念。重點(diǎn)是 Top Mgm’t要「確定」(ensure→ 可以 delegation「 授權(quán)」 )有一個(gè)process存在用以確定組織內(nèi)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(guó)外一些兒童玩具公司之「讓消費(fèi)者全程參與商品開(kāi)發(fā) —讓消費(fèi)者成為研發(fā)團(tuán)隊(duì)之“ Customerin‖概念」之落實(shí)。 Learning! . CAR, ECN, SWOT, FMEA, BSC… 9 ?為何有新版 ISO 9001:2022? 目的 ? ?應(yīng)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(jiǎn)單易懂 ? 1994年版 20個(gè)條文之問(wèn)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(zhì)管理系統(tǒng) 」 (QMS) 和「作業(yè)流程 」 (Business Processes) 相結(jié)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(gè)條文 : “ The supplier shall….‖ 」 10 ?更強(qiáng)調(diào) 「 持續(xù)改善 」 和 「客戶滿意 」 ?幾乎是向 QS9000 靠攏 ?強(qiáng)調(diào)高階管理階層之參與 (Emphasis on Top Management ): 條文 5 ?強(qiáng)調(diào)「一張?jiān)^書涵蓋總公司 /旗下多廠 」 之認(rèn)証模式 (Emphasis on Corporate