【正文】 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 development)， 或將該設計 /開發(fā)外包 (委外 ) 出去 (outsource) 執(zhí)行，那麼條文 (設計和開發(fā) ) 必須納入 品質管理系統(tǒng) (QMS) 之內。 35 簡言之，只要看「產品規(guī)格 (Product Spec.) 制定者」是誰即可很清楚釐清設計責任及「設計是否可以排外」之問題。此情況表示條文clause (Design and Development) 之某些 「 子條文」 (subclauses) 可能不適用，但不能將整個 clause 。 40 FAQ: 本公司並沒有 設計開發(fā)部門 (RD) , 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 9001:2023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 RD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 …)! 如果組織必需根據客戶 /UL安規(guī)要求 (customer/UL safety requirements:design input) 來定義 (define) 這些線種之產品特性 /規(guī)格 (product characteristics/specs:design outpout)，或稱 「開規(guī)格」，則該組織是有從事 「 (產品 ) 設計與開發(fā)」 ! 41 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 ! 42 一般產品設計工程師所產出的 Product specification產品規(guī)格 (design output)是為了下列用途 : ? 採購、生產 /製造、檢驗、包裝、安裝、及使用 … 。 44 4. 稽核 auditor必須具備行業(yè)背景 , 瞭解產品 (特性 ) , 才能正確判斷是否有設計責任 /排外。 ? 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」。 (. 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 Existing process: 從 PDCA的 C開始轉 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。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 )。 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。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