葵花宝典品质管理系统QMS

按一下以編輯母片標題樣式,*,按一下以編輯母片,第二層,第三層,第四層,第五層,葵花寶典:品質管理系統/,QMS (e.g. ISO 9001/9004:2000 , QS-9000 , ISO/IEC 17025 , ISO/TS 16949,等),之推行 & 稽核,(Conceptual Application & Assessor Handbook),Presented by Rock Chang,Country Manager,Underwriters Laboratories Inc. (Taiwan),Issued: May 28, 2001,Revised: October 15, 2002,(,簡),1,Course Objectives ,也算是知識管理(,Knowledge Management),當中的,一種知識呈現/ 知識成文化(,Knowledge,Representation):,將內隱知識(,Implicit Knowledge),成文化、外化，成,為外顯知識(,Explicit Knowledge) ,再和大家分享,(,Knowledge Sharing)!,企業知識乃指能有效解決問題的方法及資訊，又可分,為外顯知識及內隱知識。,2,說明:外顯知識是指可以有系統的語言來表示的知識 (,e.g.,企業的內部,ISO,文件&記錄等)， 內隱知識 則指無法以正式的方法表達 及溝通的知識。(,e.g.,隱藏在個別員工腦袋裡的專門技術或經驗)。,由於外顯知識才能被傳播、擷取和再使用，因此如何將內隱知識 轉化成外顯知識是企業或個人知識管理的重要課題之一，尤其是對一些知識型產業，知識型工作者，高附加價值製造業。,3,知識管理之終極目的是知識創新創值:,實施知識管理所倚重的不是資訊科技，而是一套鼓勵員工不斷創新創值的制度與文化，如讓基層員工參與研發，允許工作人員犯錯(但不可第二次犯相同的錯)，其對員工的尊重，使得該公司能得以從知識管理進入知識創造的境界，自然能不斷的創新。,組織不陷入僵化的做法，就是在創新的精神下創造一個環境，讓企業內能發生創造性的摩擦和建設性的對立，如此則可有良性循環產生，企業有源源不絕的創新觀念和行動，使企業永遠具有競爭力。而創新是必須注意到人文面，才是成功。,4,ISO/TS 16949:2002 6.2.2.4,之 :,Employee motivation and,empowerment (,員工激勵與授/賦權),The organization shall have a process to motivate employees to achieve quality objectives, to make continual improvements, and to create an environment to promote innovation. The process shall include the promotion of quality and technological awareness throughout the whole organization. (,組織必須有一流程來激勵員工 , 以達成品質目標 , 進行持續改善 , 以及建立一個能鼓勵創新之環境。此流程需包括將品質及科技意識推廣至整個組織內 。),5,Data (8.4),Information,Knowledge (is power):,ISO 9004:2000 Management should treat ,data, ( 8.4 Analysis of data) as a fundamental resource for conversion to,information, and the continual development of an organizations ,knowledge, which is essential for making factual decisions(7,th,Quality Management Principle - Factual approach to decision making /Management by (quality) Objective /CI/CA/PA) and can stimulate ,innovation,(,知識創新,e.g. 7.3 Design & Development)。,6,創新: 並非指技術研發和知識本身，而是指取得和應用知識和技術能將其轉變為市場價值的能力(,i.e. ,市場價值之創造)。這種,市場價值乃經由,市場競爭比較而來 , 而其最後之抉擇則在於滿足顧客需要的能力(,i.e.,目前政府大力推動之,Innovalue ,創新價值,)。,郭台銘說，對於一家公司而言，創新指的是速度、彈性、價格與品質的更佳化。,7,企業要靠什麼來創造價值?,行銷( 即了解與掌握顧客的需求,Input),與,創新(即為顧客提出有效的解決方法,Output): Process approach!,個人覺得,Learning Organization (,或,Organizational Learning),的真正精神是,Double-loop Learning:,Tactical (Operational), Strategic Feedback & Learning!,e.g. CAR, ECN, SWOT, FMEA, BSC,8,為何有新版,ISO 9001:2000?,目的?,應付(更適合)小公司,(Small Businesses),小而美 (,ISO 9001: 1994,不太適用小公司),更適合,各行各業 (,ISO 9001:1994,年版傾向於製造業之用),更簡單易懂,1994年版20個條文之問題:,ISO 9001:1994auditor-friendly (easy to audit but difficult for org.)vs.,ISO 9001:2000 organization-friendly,和,ISO 14001,相容,品質管理系統,(,QMS),和作業流程,(,Business Processes),相結合:,新版,ISO 9001 focuses on “how to manage a business to achieve planned/desired results (i.e. effectiveness), not on individual clauses” vs.,舊版20個條文: “,The supplier shall.”,9,更強調 持續改善,和 客戶滿意,幾乎是向,QS-9000,靠攏,強調高階管理階層之參與 (,Emphasis on Top Management ):,條文5,強調一張証書涵蓋總公司/旗下多廠,之認証模式 (,Emphasis on Corporate Registration/Certification):,更,cost & QMS effective! UL,不會為了多一些,income,而故意隱瞞此點!,Beyond certification towards performance improvement.,10,New structure of the standards should not oblige organizations to change their system documentation to match the structure of the standards.,System documentation is unique to each organization.,Requirements from the old ISO 9001:1994 have been either:,Maintained (Example-purchasing),Simplified (Example-calibration),Eliminated (Example-documentation),Structure changes,11,Features of ISO 9001:2000,Most requirements come from either:,8 Quality Management Principles,1994 version of ISO 9001,ISO 14001:1996,QS-9000 (Automotive industry),12,Single requirements standard (no more ISO 9002/3),Need for clear scope statements,Clause 1.2 “Application” (ISO/TC 176 Guidance Document + IAF Communique),Special significance of “Design & Development”,Process approach and PDCA,Comparison (Maybe a little unfair on ISO 9001:1994!),ISO 9001:1994 “Documented procedures evidenced by records”,ISO 9001:2000 “Defined and managed processes evidenced by results”,13,新版,ISO 9001:2000,稽核方式 (,AssessmentPhilosophy),有那些變更?,文件化,要求大幅減少,只剩九項強制要求和公司自覺有必要之文件:,書面化之品質政策 , 品質目標,品質手冊, 文件管制, 記錄管制, 內部稽核, 不良品管制, 矯正措施和預防措施 。,14,註:,Procedure (ISO 9000:2000 3.4.5),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”.,判定是否符合規定 : 彈性更大 !,QMS driven by quality policy, quality objectives and continuous improvement targets (,由品質政策, 品質目標及持續改善目標來驅動品質管理系統!),15,TL 9000 4.1.1 Quality Objectives - Objectives for quality shall include targets for the TL 9000 metrics defined in the TL 9000 Quality System Metrics handbook.,註:,QMS,代表,Quality Management System (,品質管理系統)。,16,QMS,和 作業流程,(,Business Processes),相結合.,:,:,所以,AR (,缺點,Action Request),如 “,The practice of .is not documented in procedure”,是不能再開的!,Flexible Requirements: ,是否符合規定之彈性更大!,*,Assessors,更被挑戰要去接受各式各樣能符合規,定 (,intent),之方法/方式,(,approaches/ways),* DOES NOT mean assessors will accept less,objective evidence of compliance,(,上述之意涵不表示,assessors,將接受更少之客觀證據就能符合要求!),17,Assessors,將需更注重以是否達成組織所訂定之量化之 (策略性) 目標來量測品質管理系統 (,QMS),之執行效果 (,effectiveness).,- ISO 9001: 2000,之4 個主要流程 (,processes),和一般之作業流程 (,Business Processes),相類似.,*,Assessors,將花更多時間來稽核作業系統(,Business Systems),和作業流程 (,Business Processes), 因大部分公司均將品質目標 (,Quality Objectives),和 營業目標 (,Business Objectives),整合在 一起.,e.g. QMS,和上市 (櫃) 9大循環 (內控系統) 結合；,QMS,和,ERP/SCM/CRM,結合 (物流，金流，資訊流零庫存/,JIT，e,化/,M,化/,IT,技術之應用)。組織進行,e,化/,M,化必會導致作業流程 ， 工作模式之改變！,18,*,ISO 9001:2000,各個子條文之,process (sub-,clause process),之執行效果將被用來決定4 個主要,processes (,條文58) 之執行效果。,八大品質管理原則(,eight quality mgmt principles),Top mgmt,應使用下列八大原則來達到績效提昇,(,improved performance):,Customer focus (,客戶導向/以客為尊/替客戶加值):,要先決定客戶是誰？,e.g.,學校:,maybe,學生、家長 (出錢的)，將來的僱主 (,process out,之使用者)，繳稅之,community,社區大眾 (公立學校)。,Clause 5.2 - Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction.,19,Remarks:,並不表示,Top Mgmt,需要親自參與合約/訂單審查。重點是,Top Mgmt,要確定(,ensure,可以,delegation,授權)有一個,process,存在用以確定組織內之人員都知道客戶需求之重要性，並且要符合客戶需求,7.2 Customer-related process,7.2.3 Customer communication,8.2.1 Customer satisfaction,e.g.,豐田汽車,及國外一些兒童玩具公司之讓消費者全程參與商品開發讓消費者成為研發團隊之“,Customer-in”,概念之落實。,20,Leadership (,領導統御/領導風格):,e.g.,麥克波特,大師主張策略競爭，強調貫徹策略的唯一辦法就是要有非常強的領導！,clause 5,的,Top Mgmt Involvement.,5.1 Mgmt commitment: Org cant hire a consultant to write a procedure for (top) mgmt commitment!,3. Involvement of people (,全員參與),TL 9000 4.1.1.C.1 Mgmt with executive responsibility should demonstrate their active involvement in long- and short-term quality planning.,QS-9000 APQP,各階段之收尾所要求的“,Mgmt Support”.,QMS,之推動絕非只是,QA,之責任,21,4. Process approach,流程(過程)導向或方式: 品質看得見，過程是關鍵！,e.g.,組織進行,e,化/,M,化(,Mobilize,化: 行動商務,M Commerce),改變作業流程 也是一種,C.I.,ISO 9001: 2000,版與舊版,ISO,最大不同處在於新版是,以流程為導向,的品質管理系統，使管理者易於採取,監控,、,量測,、,分析,與,改善,等管理手法(,i.e.,更著重於,作業流程,之,管理,、,改善,與,創新,)，比起舊版,ISO(,以條文為導向)更能有效監督企業內部各流程之運作及有效性。,22,5.,System approach to mgmt (,管理,interrelated processes,之系統管理):,e.g. 4,大,processes (mgmt, resource, production/service-provision, MAI,等)之有效管理 &,linkages,create “synergy(,綜效)” &,integration(,整合),the whole exceeds the sum of the parts.,打破,functional & departmental barriers/silos/boundaries (via communication.):,打破藩籬(內牆及外牆)!,GEs “Boundaryless (,無界限)概念”!,6. Continual improvement (,持續改善):,“,Good-Better-Best”,“Better(Q) -Cheaper(C)- Faster(D)”,7. Factual approach to decision making (,以事實/資料為根據之決策):,Clause 8,e.g. A saying: If you cant measure it, you cant manage it !,(,如果你不能衡量它，就無法管理它!),e.g. Piles and piles of records gathered but sit there to collect dust.,。,23,8. Mutually beneficial supplier relationships (,互利之中衛體系關係): 打破外牆!,Not strongly incorporated in ISO 9001:2000, but in ISO 9004:2000.,但可以延伸看成,inter-departments/internal customers,之關係:,breaking the barriers between departments.(,打破內牆!),e.g.,英航,將外包作業發揮的淋漓盡致； 企業合併是為了達到預期之綜效(,Synergy): 1+1, 2 ? What if,內鬥/內耗，勾心鬥角而形成空轉? (,a story: interviewee,反問,interviewer:,你要多少?結果他被錄取了!),以上八大原則構成,ISO 9000,系列標準之基礎。,24,注意: 前3項(,Customer focus, Leadership & Involvement of people),是屬於,soft requirements (harder to audit!),* 21,世紀強調顧客第一，員工第二，服務第三，老闆最後的領導觀念。,TS 16949:2002 NOTE The knowledge and use of the eight quality management principles referred to in ISO 9000:2000 and ISO 9004:2000 should be demonstrated and cascaded through the organization by top management.,備註,八項品質管理原則（參考,ISO 9000:2000,和,ISO 9004:2000,）,的知識和應用，應由高階管理階層加以示範並由上而下展開至整個組織。,25,FAQ: ISO 9001:1994,轉換至,ISO 9001:2000,會增加很多成本嗎？,答:,a),對於一些原先,QMS,之推行就很扎實，健全之公司 (,e.g.,一些體質良好之,High-tech Industry),而言，不是大問題。因為這些公司一開始就都很專注於,流程導向/方式&,持續改善，,高階管理階層參與，有很好之,process,來瞭解,客戶需求及有效監控及量測是否符合,客戶需求，甚至將其結合至有效之,品質目標及,客戶滿意度管理.。,26,b),但是對於一些平常就欠缺,流程導向(,Process Focus),之公司，可能就有問題。這些公司可能僅有將,ISO 9001:1994,之20個條文做成文件，並不真正了解這20個條文如何和,作業流程(,Business Processes),之間之連結及交互作用；換言之，他們沒有真正了解及落實,clause 4.1:,組織必需先,管理其流程(,the organization must start managing its processes)。,同時，他們距離達到上述,a),之水準還有一大段距離.。,Remarks:,許多通過,ISO 9001:1994,之公司之,QMS,常被詬病為由20個不怎麼相關之活動之鬆散結合，而不是緊密環環相扣之系統性結合/管理(,many ISO 9001:1994 compliant systems were actually a loose collection of 20 semirelated activities rather than a systematic approach to management.)。,27,新版,ISO 9001:2000,只剩,ISO 9001，,不像1994年版的有分,ISO 9001, ISO 9002 & ISO 9003，,因此需特別注意7.3,Design and Development (,設計與開發)有無被,排外,(,exclusion),之問題。,Exclusion (,排外),of ISO 9001:2000 requirements,“Not Applicable” due to the nature of an organization and its product:,由於組織及其產品之性質 (,nature),不同之關係，可能新的,ISO 9001:2000,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)。,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 organizations 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) :,“,產品實現,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要求之產品之該組織之能力 (,ability),或,責任 (,responsibility).,和,QS-9000,觀念一致 .,常見之排外 (,Exclusions) :,7.3 Design and Development,設計與開發:,(,Major AR if QM addresses N/A for.),29,7.5.2 Validation of Processes (Special Processes),特殊製(流)程,7.5.3 Identification and Traceability,識別與追溯,這個,clause,可能是,partially applicable，,亦即 “,Identification”,部分是,applicable (,不能排外)，但如果對組織之產品而言，並沒有特定之追溯要求時，則,Traceability,可排外。,7.5.4 Customer Property,客戶財產,假如客戶提供原始設計給工廠製造，此即構成所謂的智慧財產(,IP: Intellectual Property),而算是客戶財產，必需納入組織之,QMS,之中。(,Minor AR if QM addresses N/A for),7.6 Use of Measuring and Monitoring Devices,量測與監控儀器之使用 (例如一些服務業不需用到量具時,but how about,加油站,，,葬,x,社，,x,儀館?),30,Where the overall responsibility for,product realization,belongs to an organization, process outsourcing (,某些 “流程” 外包),is not valid justification for exclusion:,當組織對,產品實現,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。(參閱後續之,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 (,產品名稱),design. The manufacture of XXX (,產品名稱),。,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),。,Regulatory/Customer Permission to exclude applicable requirements not valid justification.:,法規,或,客戶,允許可以將某些,該適用,之條文,排外, 並非有效之排外理由。,31,e.g. A,廠為取得,ISO 9002:1994,之一生產某種,risk class,之醫療器材廠，法規並沒有強制要求生產此種醫療器材之製造商一定要將,設計管制,納入其,QMS,之中。在挑戰,ISO 9001:2000 Upgrade,時，因,A,廠本身確實有從事此種產品之,設計與開發,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7.3 (,Design and Development),排除在,QMS,之外。,認證範圍 (,Scope of Registration),可以只包含,部分產品,(,limited scope),32,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/開發責任(,design responsible)，,並且執行 (,perform),該設計/開發 (,design & development)，,或將該設計/開發外包 (委外,),出去(,outsource),執行，那麼條文7.3 (設計和開發) 必須納入,品質管理系統,(,QMS),之內。換言之，條文7.3 (設計與開發) 不可以排外。,33,Design and development,ISO 9000:2000 definition (Clause 3.4.4),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.,34,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.,e.g. software,治金業等習慣用,development,這個字，而不用,design,這個字。,Customer/regulatory/product requirements:design input,(,客戶/法規/產品要求:設計輸入),vs. product characteristics/specifications:design output,(,產品特性/規格:設計輸出),- 假如組織沒有被 (客戶) 提供,產品特性,(,product characteristics),或產品規格 (,product specifications),用以規劃其,產品實現過程,(,product realization processes)，,並且組織必須根據,客戶或法規要求,(,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(,product design and development) 。,35,-,簡言之，只要看產品規格 (,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。,-Product Spec. (,產品規格),vs. Process Spec. (,製程規格),e.g.,電鍍廠/車體塗裝烤漆廠之認証範圍 “,The (design and) provision of electro-plating (,或,painting)”,ISO/TS 16949:2002,The only permitted exclusions for this Technical Specification relate to 7.3 where the organization 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),36,附註:,i),傳統之設計與開發,(,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)。,e.g.,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,meaning,有涵蓋新保單(其,Service product),之 產品設計與開發,ISO 9001: 1994 4.4,設計管制,37,ii),組織可以選擇將設計與開發流程,(,design and development process),外包出去 (,outsource)，,這種情況就需符合,ISO 9001:2000,之,clause 4.1,之,“where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the QMS.,38,iii),一個組織不一定對,QMS,所涵蓋範圍之內之所有產品都有設計/開發責任。,iv),雖然,原始設計不屬於某一組織，但該組織可能有,責任及,權力來變更產品規格或特性。此情況表示條文,clause 7.3 (Design and Development),之某些,子條文 (,subclauses),可能不適用，但不能將整個,clause 7.3,完全排外。,e.g.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): 台灣已是全球之佼,佼者。,39,v) QS-9000 4.4,A supplier is defined as design-responsible 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 suppliers product does not waive the suppliers design responsible status.:,對於交運給客戶之,產品,而言，如果該供應商具有,權力,(,authority),來建立該(新)產品之規格，或變更該產品之現行規格，均稱該供應商具有,設計責任,(,design responsible)。,即使客戶核准 (認可) 了具有設計責任之供應商之產品 (,a design responsible suppliers product),也不能免除該供應商之設計責任。,40,FAQ:,本公司並沒有,設計開發部門,(,R&D) ,而且多年來一直都是生產非常成熟之,UL,線種,SPT-1,和,SPT-2(,根據,UL 62,電線標準) , 此情況是否可將,ISO 9001:2000,之7.3(設計和開發) 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,R&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,non-safety requirements(e.g.,顏色、外觀 、花紋)! 如果組織必需根據客戶/,UL,安規要求 (,customer/UL safety requirements:design input),來定義 (,define),這些線種之產品特性/規格 (,product characteristics/specs:design outpout)，,或稱 開規格，則該組織是有從事 7.3 (產品) 設計與開發!,41,2.,想一想 , 7.3.3之,Design and development outputs,有那些規定:,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 7.3排外!,42,一般產品設計工程師所產出的,Product specification,產品規格(,design output),是為了下列用途:,採購、生產/製造、檢驗、包裝、安裝、及使用。,註:(常見錯誤)誤將工業標準/規格，安規/法規規定，客戶招標規定當成,Product specifications (design output)。,事實上，這些通常是,design input,亦即,customer/product/regulatory requirements!,43,3.,重點: 簡單的設計(或設變) 簡單的7.3管制 簡單的設計記錄/資料(,Design Records), i.e. Design Inputs(7.3.2), Design Review(7.3.4), Design Verification(7.3.5), Design Validation(7.3.6),和,Design Changes(7.3.7),都規定要保留記錄。經驗告訴我們 , 一些傳統中小企業事實上有開規格生產 , 但較不習於保留設計記錄。,44,4.,稽核7.3之,auditor,必須具備行業背景 , 瞭解產品(特性) , 才能正確判斷是否有設計責任/排外。,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 communication channels between the locations. Assess the inputs/outputs using the process approach.,45,Activities (Steps) vs. Process (,流程),vs. Process Approach (,流程導向/方式)觀念 :, 3,puts : In,put,-Through,put,生產/,Activities- Out,put, 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),46, For an organization 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環相扣之活動。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,轉換成,輸出, 我們稱該項,活動,為一過流程)。通常一個流程之,輸出,直接構成了下一個流程之,輸入,。, The application of a system of processes within an organization, 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。,47,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 combination and interaction.,流程導向其中一個好處是 , 它能針對流程系統內的各個流程之間之,連結,組合,以及,交互作用,提供,持續性之控管, 。,48,When used within a QMS, such an approach emphasizes the importance of,Understanding and fulfilling the requirements,The need to consider processes in terms of added value,Obtaining results of process performance and effectiveness, and,Continual improvement of processes based on objective measurement.,如將,流程導向應用於品質管理系統 , 它能強化下列各項之重要性:,瞭解,及,滿足,(,符合,)規定,需要以是否能,提高附加價值,來思考,流程,取得流程績效/表現及效果之結果 , 和,依據,客觀量測,而進行之流程之持續改善。,49,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 9001:2000),EFFICIENCY OF PROCESS=Results acieved vs resources used (Focus of ISO 9004:2000),(Includes Resources),Focus of TS-2: Effectiveness+Efficiency,50,PDCA/PDSA (Plan-Do-Check-Act,或,Plan-Do-Study-