【正文】 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 ! 42 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 … 。 事實上，這些通常是 design input?亦即 customer/product/regulatory requirements! 43 : 簡單的設計 (或設變 ) 簡單的 簡單的「設計記錄 /資料」(Design Records), . Design Inputs(), Design Review(), Design Verification(), Design Validation()和 Design Changes()都規(guī)定要保留記錄。 44 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。假如有一項 活動 , 它使用了 資源 , 並且「被管理」 , 以至於能將 輸入 轉(zhuǎn)換成 輸出 , 我們稱該項 活動 為一過「流程」 )。 ? 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」。 48 When used within a QMS, such an approach emphasizes the importance of a) Understanding and fulfilling the requirements, b) The need to consider processes in terms of added value, c) Obtaining results of process performance and effectiveness, and d) Continual improvement of processes based on objective measurement. e) 如將 「流程導向」應用於品質(zhì)管理系統(tǒng) , 它能強化下列各項之重要性 : f) 瞭解 及 滿足 (符合 )規(guī)定 , g) 需要以是否能 提高附加價值 來思考 流程 , h) 取得流程績效 /表現(xiàn)及效果之結果 , 和 i) 依據(jù) 客觀量測 而進行之流程之持續(xù)改善。 (. 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!) 51 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: 52 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) 53 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 54 P r o c e s s A p p r o a c h M o d e lP R O C E S SP R O D U C T R E A L I Z A T I O NR E S O U R C E M A N A G E M E N TCUSTOMERCUSTOMERM A N A G E M E N T R E S P O N S I B I L I T YM e a s u r e m e n t ,A n a l y s i s ,i m p r o v e m e n tSatisfactionP r o d u c tO u t p u tI n p u tRequirementC o n t i n u a l I m p r o v e m e n t o f t h e Q u a l i t yM a n a g e m e n t S y s t e m55 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 development process ?Purchasing process ?Production service provision ?Control of monitoring and measuring devices (Fig 1) Quality Management System Processes 56 Correct Identify Core Processes (COP’s) Needs Expectations Improve? Process Design Product Design A NO D YES Customers OK? C Check Results P 57 ? ISO 9001: 2023 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。當達不到既定 /預期之結果時 , 組織 必須採取適當之改正及矯正措施 , 以確保產(chǎn)品能符合規(guī)定 )。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 )。 如果某一個量度缺乏支持的資料 (. missing measurements)，問題可能是某一個主要策略目標的管理流程未臻完善 (robust) 或根本不存在。 61 Measurements of process performance should cover the needs and expectations of interested parties in a balanced manner (. BSC). Examples include 以追求各個不同構面之間之平衡， 流程績效之量測 應該涵蓋相關利益團體之需求和期望。 ? linked/interacted/interrelated (交互作用 /環(huán)環(huán)相扣 ) 觀念 : The revised ISO 9001:2023 standard now follows a process approach: 大體上分為 Clause 7之 Product Realization Processes 「 產(chǎn)品實現(xiàn)流程 (戰(zhàn)單位 /功能 )」 Clauses 4, 5, 6 8 之 Associated Support Processes「 相關之支援流程( /功能 )」兩大類 65 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。而 日式的過程管理 係著重為了要達成任務有那些事情是必須要做的，日本人深信 只要盡力去完成該做的事，那麼結果自然不會太差。 ?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