【正文】 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。 註 :(常見錯(cuò)誤 )誤將工業(yè)標(biāo)準(zhǔn) /規(guī)格，安規(guī) /法規(guī)規(guī)定，客戶招標(biāo)規(guī)定當(dāng)成 Product specifications (design output)。 ? 據(jù)聞過去有些認(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)」。 48 ? 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(dǎo)向」其中一個(gè)好處是 , 它能針對(duì)「流程系統(tǒng)內(nèi)的各個(gè)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 」 。 (. 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(zhuǎn) Existing process: 從 PDCA的 C開始轉(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。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。 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 !) 」?？赡苤繙y(cè)指標(biāo)有 : capability, (製程能力 , . Cpk) reaction time, (反應(yīng) /回覆時(shí)間 ) cycle time or throughput . 製造週期效能 (manufacturing cycle effectiveness, MCE)= 加工時(shí)間 (Processing Time) 產(chǎn)出時(shí)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(jī)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 9000:20xx 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(shí)，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。 過去習(xí)慣上我們會(huì)只問結(jié)果，不管它是如何達(dá)成的，因此我們可能投機(jī)取巧，留下甚多的後遺癥。 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(shí) 」