【正文】 vement 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。 50 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 9001:2022) EFFICIENCY OF PROCESS=Results acieved vs resources used (Focus of ISO 9004:2022) (Includes Resources) Focus of TS2: Effectiveness+Efficiency 51 ? PDCA/PDSA (PlanDoCheckAct 或 PlanDoStudyAct: 計(jì)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(jì)劃 ) * Execute the work (Do 執(zhí)行 ) * Measure the results (Check 檢討 ) * Identify improvements (Act 改善 ): 含 CI , CA amp。 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 」 。通常一個(gè)流程之 輸出 直接構(gòu)成了下一個(gè)流程之 輸入 。 ? 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)」。經(jīng)驗(yàn)告訴我們 , 一些傳統(tǒng)中小企業(yè)事實(shí)上有「開規(guī)格」生產(chǎn) , 但較不習(xí)於保留「設(shè)計(jì)記錄」。 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)。D) , 而且多年來一直都是生產(chǎn)非常成熟之 UL線種 SPT1和 SPT2(根據(jù) UL 62電線標(biāo)準(zhǔn) ) , 此情況是否可將 ISO 9001:2022之 (設(shè)計(jì)和開發(fā) ) 排外 ? If not, 在未來幾年 , 我們也可能無任何新設(shè)計(jì)案 !? Ans: 1. 問題不在有無 Ramp。 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。 . OEM: Original Equipment Manufacturer (原始設(shè)備製造商 ) ODM: Original Design Manufacturer (原始設(shè)計(jì)製造商 ) EMS: Electronics Manufacturing Service (電子製造服務(wù) /電子代工業(yè) ): 臺(tái)灣已是全球之佼 佼者。 iv) 雖然 「 原始設(shè)計(jì)」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。 Product Spec. (產(chǎn)品規(guī)格 ) vs. Process Spec. (製程規(guī)格 ) . 電鍍廠 /車體塗裝烤漆廠之認(rèn)証範(fàn)圍 “ The (design and) provision of electroplating (或 painting)‖ ISO/TS 16949:2022 The only permitted exclusions for this Technical Specification relate to where the anization is not responsible for product design and development. Permitted exclusions do not include manufacturing process design. (製程設(shè)計(jì)不可以被排外 ) 37 附註 : i) 傳統(tǒng)之「設(shè)計(jì)與開發(fā) 」 (design and development) 是針對(duì)有形之「產(chǎn)品 」 (product)， 但亦適用於服務(wù) service (無形之產(chǎn)品 )。 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)與開發(fā)」(product design and development) 。換言之，條文 (設(shè)計(jì)與開發(fā) ) 不可以排外。 認(rèn)證範(fàn)圍 (Scope of Registration) 可以只包含 部分產(chǎn)品 (limited scope) 33 Design and Development ? 看 IAF Guidance 2. 假如組織對(duì)於認(rèn)証範(fàn)圍之內(nèi)之產(chǎn)品具有設(shè)計(jì) /開發(fā)責(zé)任 (design responsible)， 並且執(zhí)行 (perform) 該設(shè)計(jì) /開發(fā) (design amp。 32 . A廠為取得 ISO 9002:1994之一生產(chǎn)某種 risk class之醫(yī)療器材廠，法規(guī)並沒有強(qiáng)制要求生產(chǎn)此種醫(yī)療器材之製造商一定要將 設(shè)計(jì)管制 納入其 QMS之中。假使是委外給通過 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 ) 」。 (Minor AR if QM addresses N/A for…) Use of Measuring and Monitoring Devices 「量測(cè)與監(jiān)控儀器之使用」 (例如一些服務(wù)業(yè)不需用到量具時(shí) , but how about加油站 ， 葬 x社， x儀館 …?) 31 Where the overall responsibility for product realization belongs to an anization, process outsourcing (某些 “流程” 外包 ) is not valid justification for exclusion: 「當(dāng)組織對(duì) 產(chǎn)品實(shí)現(xiàn) 負(fù)全責(zé)時(shí)，將某些過程 /流程 (processes) 外包出去」 並非有效之「排外」 (exclusions) 之理由。 Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to reqmts within clause 7, and such exclusions do not affect the anization’s ability, or responsibility, to provide product that meets customer and applicable regulatory reqmts. 29 該「排外」 (exclusions) 只限制適用於「條文 7」 (clause 7) : “ 產(chǎn)品實(shí)現(xiàn) Product Realization‖之條文，且該「排外」不能影響到組織為供應(yīng)能符合客戶和法規(guī)要求之產(chǎn)品之該組織之「能力」 (ability) 或 「責(zé)任」 (responsibility). ?和 QS9000 觀念一致 . ? 常見之「排外」 (Exclusions) : Design and Development 「設(shè)計(jì)與開發(fā)」 : (Major AR if QM addresses N/A for….) 30 Valida