【正文】 ?COP:Customer Oriented/Focused Process/Procedure(替顧客加值之流程 ): 程序 /流程是手段，目的是為顧客創(chuàng)造價值，因此任何程序之設計要「從顧客需要著手」 ，而非企業(yè)的需要。 8 之 Associated Support Processes「 相關(guān)之支援流程( /功能 )」兩大類 66 過程 (流程 )管理 : ?過程管理 意指完成某項任務，需要透過一連串活動的完成，才能達到目的。 62 Measurements of process performance should cover the needs and expectations of interested parties in a balanced manner (. BSC). Examples include 以追求各個不同構(gòu)面之間之平衡， 流程績效之量測 應該涵蓋相關(guān)利益團體之需求和期望。組織應該將這些量測溶入流程之中 , 並且使用這些量測來做流程管理 )。 Expectations Improve? Process Design Product Design A NO D YES Customers OK? C Check Results P 58 ? ISO 9001: 2022 Monitoring and measurement of processes (流程之監(jiān)督與量測 ) The anization shall apply suitable methods for monitoring and, where applicable, measurement of the QMS processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure conformity of the product. (組織必須使用適當之方法來 監(jiān)督 和 , 必要時 , 量測 QMS之流程。 PA ISO 9001:2022 更強調(diào) “ Plan‖ 和 “ Act‖, 此兩項是 多數(shù)公司較弱之地方。 ? The application of a system of processes within an anization, together with the identification and interactions and managing of these processes can be referred to as the ―process approach‖. 那麼 , 何謂「流程導向 /方式」呢 ? 一個組織內(nèi)之所有流程之有系統(tǒng)之結(jié)合與運作 , 加上對這些流程之 鑑別 , 交互作用 及 管理 , 稱之為「流程導向 /方式」。 45 4. 稽核 auditor必須具備行業(yè)背景 , 瞭解產(chǎn)品 (特性 ) , 才能正確判斷是否有設計責任 /排外。D部門之設立 , 想一想 product ―characteristics‖(distinguishing features)/product specs (design output)是誰訂的 ? UL62 電線標準只告訴你一些safety requirements (design input) , 它並沒有告訴你其他nonsafety requirements(. 顏色、外觀 、花紋 …)! 如果組織必需根據(jù)客戶 /UL安規(guī)要求 (customer/UL safety requirements:design input) 來定義 (define) 這些線種之產(chǎn)品特性 /規(guī)格 (product characteristics/specs:design outpout)，或稱 「開規(guī)格」，則該組織是有從事 「 (產(chǎn)品 ) 設計與開發(fā)」 ! 42 2. 想一想 , Design and development outputs有那些規(guī)定 : The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release. Design and development outputs shall a) meet the input requirements for design and developments, b) provide appropriate information for purchasing, production and for service provision, c) contain or reference product acceptance criteria, and d) specify the characteristics of the product that are essential for its safe and proper use. 上述之 design outputs是誰訂的 ? 如果是組織本身，那麼我們可以說「組織俱有設計責任 /能力」，不能將 ! 43 一般產(chǎn)品設計工程師所產(chǎn)出的 Product specification產(chǎn)品規(guī)格 (design output)是為了下列用途 : ? 採購、生產(chǎn) /製造、檢驗、包裝、安裝、及使用 … 。 40 v) QS9000 — A supplier is defined as designresponsible if it has the authority to esbablish a new, or change an existing product specification for any product shipped to a customer. Customer approval of a design responsible supplier’s product does not waive the supplier’s design responsible status.:對於交運給客戶之 產(chǎn)品 而言，如果該供應商具有 權(quán)力 (authority) 來建立該 (新 )產(chǎn)品之規(guī)格，或變更該產(chǎn)品之現(xiàn)行規(guī)格，均稱該供應商具有 設計責任 (design responsible)。 . 我看過 國泰人壽 之大幅廣告寫著 ISO 9002認証，這樣對嗎？ 答 : Yes, 假如認証範圍只是 國泰 一個 營業(yè)所 , 負責拉保險 , 收費 , 客服 … 等 No, 假如認証範圍是整個 國泰 集團之作業(yè) … meaning 有涵蓋「新保單」 (其 Service product) 之 產(chǎn)品設計與開發(fā) 「 ISO 9001: 1994 設計管制」 38 ii) 組織可以選擇將「設計與開發(fā)流程 」 (design and development process) 外包出去 (outsource)， 這種情況就需符合 ISO 9001:2022之 clause 之 ―where an anization chooses to outsource any process that affects product conformity with requirements, the anization shall ensure control over such processes. Control of such outsourced processes shall be identified within the QMS. 39 iii) 一個組織不一定對 QMS所涵蓋範圍之內(nèi)之所有產(chǎn)品都有設計 /開發(fā)責任。 34 Design and development ISO 9000:2022 definition (Clause ) Set of processes that transforms requirements into specified characteristics Distinguishing feature (Physical, sensory, behavioural,Temporal, ergonomic, functional) Need or expectation that is stated, generally implied or obligatory. 35 NOTE 1 the terms ―design‖ and ―development‖ are sometimes used synonymously and sometimes used to define different stages of the overall design and development process. . software, 治金業(yè)等習慣用 development這個字，而不用 design這個字。在挑戰(zhàn) ISO 9001:2022 Upgrade時，因 A廠本身確實有從事此種產(chǎn)品之 設計與開發(fā)活動，而且此種活動確實也會影響其符合客戶要求之能力 (the activity does affect its ability to meet customer requirements)， 因此 A廠決定不將 (Design and Development) 排除在 QMS之外。 (參閱後續(xù)之 Appriopriate Control之 item H 和 Stronger Purchasing Control兩部分之詳細說明 ) Remarks: 假如公司將 design 委外給沒有通過 ISO 9000 之公司時 , Scope為「 The Management of subcontracted (或 outsourced) XXX (產(chǎn)品名稱 ) design. The manufacture of XXX (產(chǎn)品名稱 ) 」。 ? Exclusion (排外 ) of ISO 9001:2022 requirements ―Not Applicable‖ due to the nature of an anization and its product: 由於組織及其產(chǎn)品之「性質(zhì) 」 (nature) 不同之關(guān)係，可能新的 ISO 9001:2022標準有某些條文可以不適用，那麼這些不適用之情況可以被考慮當成「排外 」 (exclusion)。 同時，他們距離達到上述 a)之水準還有一大段距離 …. 。因為這些公司一開始就都很專注於 「 流程導向 /方式」 amp。 25 注意 : 前 3項 (Customer focus, Leadership amp。 linkages?create ―synergy(綜效 )” amp。 Clause Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction. 20 Remarks: 並不表示 Top Mgm’t需要親自參與「合約 /訂單審查」。 15 註 : Procedure (ISO 9000:2022 ) Specified way to carry out an activity or a process NOTE 1 procedures can be documented or not. NOTE 2 When a procedure is documented, the term ―written procedure‖ or ―documented procedure‖ is frequently used. The document that contains a procedure can be called a ―procedure document‖. 判定「是否符合規(guī)定」 : 彈性更大 ! QMS driven by quality policy, quality objectives and continuous improvement targets (由「品質(zhì)政策」 , 「品質(zhì)目標」及「持續(xù)改善目標」來驅(qū)動「品質(zhì)管理系統(tǒng)」 !) 16 ※ TL 9000 Quality Objectives Objectives for quality shall include targets for th