【正文】 ISO 9004:2023 Management should treat 「 data 」 ( Analysis of data) as a fundamental resource for conversion to「 information 」 and the continual development of an anization’s 「 knowledge 」 , which is essential for 「 making factual decisions」 (7th Quality Management Principle Factual approach to decision making /Management by (quality) Objective /CI/CA/PA) and can stimulate 「 innovation」 (「 知識(shí)創(chuàng)新」. – Design Development)。 八大品質(zhì)管理原則 (eight quality mgmt principles) Top mgmt 應(yīng)使用下列八大原則來(lái)達(dá)到「績(jī)效提昇」 (improved performance): 1. Customer focus (客戶導(dǎo)向 /以客為尊 /替客戶加值 ): 2. 要先決定「客戶」是誰(shuí)？ . 學(xué)校 : maybe 學(xué)生、家長(zhǎng) (出錢的 )，將來(lái)的僱主 (process out之使用者 )，繳稅之munity社區(qū)大眾 (公立學(xué)校 )… 。 25 FAQ: 「 ISO 9001:1994轉(zhuǎn)換至 ISO 9001:2023」會(huì)增加很多成本嗎？ 答 : a)對(duì)於一些原先 QMS之推行就很扎實(shí)，健全之公司 (. 一些體質(zhì)良好之 Hightech Industry)而言，不是大問(wèn)題。 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. 28 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….) 29 Validation of Processes (Special Processes) 「特殊製 (流 )程」 Identification and Traceability 「識(shí)別與追溯」 ?這個(gè) clause可能是 partially applicable， 亦即 “ Identification‖部分是 applicable (不能排外 )，但如果對(duì)組織之產(chǎn)品而言，並沒有特定之追溯要求時(shí)，則 Traceability可排外。 認(rèn)證範(fàn)圍 (Scope of Registration) 可以只包含 部分產(chǎn)品 (limited scope) 32 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 development)， 或?qū)⒃撛O(shè)計(jì) /開發(fā)外包 (委外 ) 出去 (outsource) 執(zhí)行，那麼條文 (設(shè)計(jì)和開發(fā) ) 必須納入 品質(zhì)管理系統(tǒng) (QMS) 之內(nèi)。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(gè) clause 。 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(shè)計(jì)責(zé)任 /排外。 (. 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(cè) ) 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(dāng)之方法來(lái) 監(jiān)督 和 , 必要時(shí) , 量測(cè) QMS之流程。 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(gè)不同構(gòu)面之間之平衡， 流程績(jī)效之量測(cè) 應(yīng)該涵蓋相關(guān)利益團(tuán)體之需求和期望