【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 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. 「流程導向」其中一個好處是 , 它能針對「流程系統(tǒng)內的各個流程之間之 連結 , 組合 以及 交互作用 提供 持續(xù)性之控管 」 。通常一個流程之 輸出 直接構成了下一個流程之 輸入 。 ? 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」。經驗告訴我們 , 一些傳統(tǒng)中小企業(yè)事實上有「開規(guī)格」生產 , 但較不習於保留「設計記錄」。 註 :(常見錯誤 )誤將工業(yè)標準 /規(guī)格，安規(guī) /法規(guī)規(guī)定，客戶招標規(guī)定當成 Product specifications (design output)。D) , 而且多年來一直都是生產非常成熟之 UL線種 SPT1和 SPT2(根據 UL 62電線標準 ) , 此情況是否可將 ISO 9001:2022之 (設計和開發(fā) ) 排外 ? If not, 在未來幾年 , 我們也可能無任何新設計案 !? Ans: 1. 問題不在有無 Ramp。 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。 . OEM: Original Equipment Manufacturer (原始設備製造商 ) ODM: Original Design Manufacturer (原始設計製造商 ) EMS: Electronics Manufacturing Service (電子製造服務 /電子代工業(yè) ): 臺灣已是全球之佼 佼者。 iv) 雖然 「 原始設計」不屬於某一組織，但該組織可能有 「 責任」及 「 權力」來變更產品規(guī)格或特性。 Product Spec. (產品規(guī)格 ) vs. Process Spec. (製程規(guī)格 ) . 電鍍廠 /車體塗裝烤漆廠之認証範圍 “ 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. (製程設計不可以被排外 ) 37 附註 : i) 傳統(tǒng)之「設計與開發(fā) 」 (design and development) 是針對有形之「產品 」 (product)， 但亦適用於服務 service (無形之產品 )。 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(xiàn)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) 。換言之，條文 (設計與開發(fā) ) 不可以排外。 認證範圍 (Scope of Registration) 可以只包含 部分產品 (limited scope) 33 Design and Development ? 看 IAF Guidance 2. 假如組織對於認証範圍之內之產品具有設計 /開發(fā)責任 (design responsible)， 並且執(zhí)行 (perform) 該設計 /開發(fā) (design amp。 32 . A廠為取得 ISO 9002:1994之一生產某種 risk class之醫(yī)療器材廠，法規(guī)並沒有強制要求生產此種醫(yī)療器材之製造商一定要將 設計管制 納入其 QMS之中。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 ) 」。 (Minor AR if QM addresses N/A for…) Use of Measuring and Monitoring Devices 「量測與監(jiān)控儀器之使用」 (例如一些服務業(yè)不需用到量具時 , 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: 「當組織對 產品實現(xiàn) 負全責時，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) : “ 產品實現(xiàn) Product Realization‖之條文，且該「排外」不能影響到組織為供應能符合客戶和法規(guī)要求之產品之該組織之「能力」 (ability) 或 「責任」 (responsibility). ?和 QS9000 觀念一致 . ? 常見之「排外」 (Exclusions) : Design and Development 「設計與開發(fā)」 : (Major AR if QM addresses N/A for….) 30 Valida