ISO9000-ISO16949-QS9000推行

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,CourseObjectives,也算是,知,知識管理,(,Knowledge Management),當中的,一種知,識,識呈現/ 知,識,識成文化,(,Knowledge,Representation):,將內隱,知,知識(,ImplicitKnowledge),成文化、,外,外化，成,為外顯,知,知識(,ExplicitKnowledge),再和大家,分,分享,(,Knowledge Sharing)!,企業知識,乃,乃指能有,效,效解決問,題,題的方法,及,及資訊，,又,又可分,為外顯,知,知識及,內隱知,識,識。,2,說明:,外顯,知,知識,是,是指可,以,以有系,統,統的語,言,言來表,示,示的知,識,識 (,e.g.,企業的,內,內部,ISO,文件&,記,記錄,等,等)，,內,隱,隱知識, 則,指,指無法,以,以正式,的,的方法,表,表達,及,及溝通,的,的知識,。,。(,e.g.,隱藏在,個,個別員,工,工腦袋,裡,裡的專,門,門技術,或,或經驗)。,由於外,顯,顯知識,才,才能被,傳,傳播、,擷,擷取和,再,再使用,，,，因此,如,如何將,內隱,知,知識,轉,轉化,成,成外,顯,顯知識,是企,業,業或個,人,人知識,管,管理的,重,重要課,題,題之一,，,，尤其,是,是對一,些,些知識,型,型產業,，,，知識,型,型工作,者,者，高,附,附加價,值,值製造,業,業。,3,知識,管,管理,之,之終極,目,目的是,知識,創,創新創,值,值:,實施知,識,識管理,所,所倚重,的,的不是,資,資訊科,技,技，而,是,是一套,鼓,鼓勵員,工,工不斷,創,創新創,值,值的制,度,度與文,化,化，如,讓,讓基層,員,員工參,與,與研發,，,，允許,工,工作人,員,員犯錯(但不,可,可第二,次,次犯相,同,同的錯)，其,對,對員工,的,的尊重,，,，使得,該,該公司,能,能得以,從,從知識,管,管理進,入,入知識,創,創造的,境,境界，,自,自然能,不,不斷的,創,創新。,組織不,陷,陷入僵,化,化的做,法,法，就,是,是在創,新,新的精,神,神下創,造,造一個,環,環境，,讓,讓企業,內,內能發,生,生創造,性,性的摩,擦,擦和建,設,設性的,對,對立，,如,如此則,可,可有良,性,性循環,產,產生，,企,企業有,源,源源不,絕,絕的創,新,新觀念,和,和行動,，,，使企,業,業永遠,具,具有競,爭,爭力。,而,而創新,是,是必須,注,注意到,人,人文面,，,，才是,成,成功。,4,ISO/TS16949:20026.2.2.4,之 :,Employeemotivation andempowerment(,員工激,勵,勵與授/賦權),Theorganization shall haveaprocess to motivate employeestoachieve qualityobjectives,tomakecontinualimprovements,andtocreate an environment to promoteinnovation.Theprocess shall includethe promotionofquality andtechnological awarenessthroughout thewholeorganization. (,組織必,須,須有一,流,流程來,激,激勵員,工,工 ,以,以達,成,成品質,目,目標, 進,行,行持續,改,改善, 以,及,及建立,一,一個能,鼓,鼓勵創,新,新之環,境,境。此,流,流程需,包,包括將,品,品質及,科,科技意,識,識推廣,至,至整個,組,組織內,。,。),5,Data (8.4),Information,Knowledge(is power):,ISO9004:2000Managementshould treat data (8.4 Analysis of data) as afundamentalresourcefor conversionto,information andthecontinual development of an organizations knowledge,whichisessentialfor making factualdecisions(7,th,Quality ManagementPrinciple - Factualapproachtodecisionmaking /Management by (quality)Objective/CI/CA/PA)andcan stimulate,innovation(,知識創,新,新,e.g. 7.3Design &Development)。,6,創新: 並,非,非指,技,技術研,發,發和,知識,本身,，,，而是,指,指取得,和,和應用,知識,和,技,技術,能,能將其,轉,轉變為,市,市場價,值,值的能,力,力(,i.e. ,市場價,值,值之,創,創造),。,。這種,市場價,值,值乃,經,經由,市場競,爭,爭比,較,較而來,而,而其最,後,後之抉,擇,擇則在,於,於滿足,顧,顧客需,要,要的能,力,力(,i.e.,目前政,府,府大力,推,推動之,Innovalue,創新價,值,值,)。,郭台銘,說,說，對,於,於一家,公,公司而,言,言，創,新,新指的,是,是速度,、,、彈性,、,、價格,與,與品質,的,的更佳,化,化。,7,企業要靠什,麼,麼來創造價,值,值?,行銷( 即,了,了解與掌握,顧,顧客的需求,Input),與,創新(即為,顧,顧客提出有,效,效的解決方,法,法,Output): Process approach!,個人覺得,Learning Organization (,或,OrganizationalLearning),的真正精神,是,是,Double-loop Learning:,Tactical (Operational),StrategicFeedback &Learning!,e.g.CAR,ECN,SWOT,FMEA, BSC,8,為何有新,版,版,ISO 9001:2000?,目的?,應付(更適,合,合)小公司,(Small Businesses),小而美(,ISO 9001:1994,不太適用小,公,公司),更適合,各行各業(,ISO 9001:1994,年版傾向於,製,製造業之用),更簡單易懂,1994年,版,版20個條,文,文之問題:,ISO 9001:1994auditor-friendly(easy toauditbutdifficultfor org.)vs.,ISO 9001:2000 organization-friendly,和,ISO 14001,相容,品質管理,系,系統,(,QMS),和,作,作,業,業,流,流,程,程,(,BusinessProcesses),相,結,結,合,合:,新,新,版,版,ISO 9001 focuses on,“,“howto managea businessto achieve planned/desired results(i.e. effectiveness), not onindividualclauses”,vs.,舊版20,個,個條文:,“,“,The supplier shall.,”,”,9,更強調 ,持,持續改善,和 客戶,滿,滿意,幾乎,是,是向,QS-9000,靠攏,強調,高,高階,管,管理,階,階層,之,之參,與,與(,EmphasisonTopManagement):,條文5,強調,一,張,張証,書,書涵,蓋,蓋總,公,公司/旗,下,下多,廠,廠,之認,証,証模,式,式(,EmphasisonCorporateRegistration/Certification):,更,cost&QMSeffective!UL,不會,為,為了,多,多一,些,些,income,而故,意,意隱,瞞,瞞此,點,點!,Beyondcertificationtowardsperformanceimprovement.,10,Newstructure ofthestandards should not obligeorganizations to changetheir system documentationtomatch the structureof the standards.,System documentationisunique to each organization.,Requirementsfrom the old ISO 9001:1994havebeen either:,Maintained (Example-purchasing),Simplified (Example-calibration),Eliminated (Example-documentation),Structurechanges,11,FeaturesofISO9001:2000,Most requirementscome fromeither:,8 QualityManagementPrinciples,1994 versionofISO 9001,ISO14001:1996,QS-9000 (Automotive industry),12,Single requirementsstandard (no more ISO 9002/3),Needfor clearscopestatements,Clause 1.2,“,“Application”(ISO/TC 176 GuidanceDocument+ IAFCommunique),Special significanceof “Design & Development,”,”,Process approach andPDCA,Comparison(Maybe alittle unfair on ISO9001:1994!),ISO9001:1994 “Documented proceduresevidenced by records”,ISO9001:2000 “Defined and managed processesevidenced by results”,13,新版,ISO9001:2000,稽核方式(,AssessmentPhilosophy),有,那,那,些,些,變,變,更,更?,文,件,件,化,化,要,求,求,大,大,幅,幅,減,減,少,少,只,剩,剩,九,九,項,項,強,強,制,制,要,要,求,求,和,和,公,公,司,司,自,自,覺,覺,有,有,必,必,要,要,之,之,文,文,件,件,:,書,面,面,化,化,之,之,品,品,質,質,政,政,策,策,品,品,質,質,目,目,標,標,品,品,質,質,手,手,冊,冊,文,文,件,件,管,管,制,制,記,記,錄,錄,管,管,制,制,內,內,部,部,稽,稽,核,核,不,不,良,良,品,品,管,管,制,制,矯,矯,正,正,措,措,施,施,和,和,預,預,防,防,措,措,施,施,。,。,14,註:,Procedure(ISO9000:20003.4.5),Specifiedway to carry outanactivityora process,NOTE 1procedurescanbedocumentedornot.,NOTE 2Whena procedureisdocumented,theterm,“,“writtenprocedure,”,” or “documented procedure”isfrequentlyused.The document thatcontainsaprocedurecan be calleda “proceduredocument,”,”.,判定,是,是否符,合,合規定, :,彈,彈性,更,更大!,QMSdriven by qualitypolicy,quality objectivesand continuousimprovementtargets(,由品,質,質政策,品質,目,目標,及,及持,續,續改善,目,目標,來,來驅動,品質,管,管理系,統,統!),15,TL9000 4.1.1 QualityObjectives-Objectives forquality shall includetargetsforthe TL 9000metricsdefined in theTL9000 QualitySystem Metricshandbook.,註:,QMS,代表,Quality ManagementSystem(,品質管,理,理系統)。,16,QMS,和,作,業,業流,程,程,(,BusinessProcesses),相結,合,合.,:,:,所以,AR(,缺點,ActionRequest),如,“,“,Thepracticeof,.isnotdocumentedinprocedure”,是不,能,能再,開,開的!,FlexibleRequirements:,是否,符,符合,規,規定,之,彈,彈性,更,更大!,*,Assessors,更被,挑,挑戰,要,要去,接,接受,各,各式,各,各樣,能,能符,合,合規,定 (,intent),之方法/方式,(,approaches/ways),* DOES NOT meanassessors will accept less,objective evidence of compliance,(,上述之意,涵,涵不表示,assessors,將接受更,少,少之客觀,證,證據就能,符,符合要求!),17,Assessors,將需更注,重,重以是,否,否達成組,織,織所訂定,之,之量化之(策略,性,性) 目,標,標來量,測,測品質,管,管理系統, (,QMS),之執行效,果,果 (,effectiveness).,- ISO 9001:2000,之4 個,主,主要流程(,processes),和一般之,作業流,程,程 (,BusinessProcesses),相類似.,*,Assessors,將花更多,時,時間來稽,核,核作業,系,系統(,BusinessSystems),和作業,流,流程(,BusinessProcesses), 因大,部,部分公司,均,均將品,質,質目標(,QualityObjectives),和,營,營,業,業,目,目,標,標,(,Business Objectives),整合在 一,起,起.,e.g.QMS,和上市 (,櫃,櫃) 9大循環(內控系,統,統) 結合,；,；,QMS,和,ERP/SCM/CRM,結合 (物,流,流，金流，,資,資訊流零,庫,庫存/,JIT，e,化/,M,化/,IT,技術之應,用,用)。組,織,織進行,e,化/,M,化必會導,致,致作業流,程,程 ，,工作模式,之改變！,18,*,ISO 9001:2000,各個子條,文,文之,process (sub-,clause process),之執行效果,將,將被用來決,定,定4 個主,要,要,processes(,條文58) 之執行,效,效果。,八大,品,品質,管,管理,原,原則(,eightqualitymgmtprinciples),Topmgmt,應,使,使,用,用,下,下,列,列,八,八,大,大,原,原,則,則,來,來,達,達,到,到,績,績,效,效,提,提,昇,昇,(,improvedperformance):,Customerfocus(,客,戶,戶,導,導,向,向/,以,以,客,客,為,為,尊,尊/,替,替,客,客,戶,戶,加,加,值,值):,要,先,先,決,決,定,定,客,客,戶,戶,是,是,誰,誰,？,？,e.g.,學,校,校:,maybe,學,生,生,、,、,家,家,長,長(,出,出,錢,錢,的,的),，,，,將,將,來,來,的,的,僱,僱,主,主(,process out,之使用,者,者)，,繳,繳稅之,community,社區大,眾,眾 (,公,公立學,校,校),。,。,Clause5.2 -Top managementshallensure thatcustomerrequirements aredetermined andaremet withthe aimofenhancingcustomersatisfaction.,19,Remarks:,並不表,示,示,TopMgmt,需要親,自,自參與,合約/訂單,審,審查,。,。重點,是,是,TopMgmt,要確,定,定(,ensure,可以,delegation,授權)有一,個,個,process,存在用,以,以確定,組,組織內,之,之人員,都,都知道,客戶,需,需求,之,之重要,性,性，並,且,且要符,合,合客,戶,戶需求,7.2Customer-relatedprocess,7.2.3Customercommunication,8.2.1Customersatisfaction,e.g.,豐田汽,車,車,及國外,一,一些兒,童,童玩具,公,公司之,讓消,費,費者全,程,程參與,商,商品開,發,發讓,消,消費者,成,成為研,發,發團隊,之,之“,Customer-in”,概念,之,之落實,。,。,20,Leadership (,領導統,御,御/領,導,導風格):,e.g.,麥克,波,波特,大師主,張,張策,略,略競爭,，強,調,調貫,徹,徹策略,的,的唯一,辦,辦法就,是,是要有,非,非常強,的,的領導,！,！,clause5,的,TopMgmtInvolvement.,5.1Mgmtcommitment:Orgcanthirea consultanttowriteaprocedurefor (top) mgmtcommitment!,3.Involvementofpeople (,全員參,與,與),TL9000 4.1.1.C.1Mgmt withexecutive responsibility shoulddemonstratetheiractiveinvolvementinlong-and short-termqualityplanning.,QS-9000APQP,各階段之,收,收尾所要,求,求的“,MgmtSupport,”,”.,QMS,之推動絕,非,非只是,QA,之責任,21,4. Process approach,流程(過,程,程)導向,或,或方式:,品,品質看,得,得見，,過,過程是,關,關鍵！,e.g.,組織進行,e,化/,M,化(,Mobilize,化: 行,動,動商務,M Commerce),改變作,業,業流程,也是,一,一種,C.I.,ISO9001: 2000,版與舊版,ISO,最大不同,處,處在於,新,新版是,以流程為,導,導向,的品質管,理,理系統，,使,使管理者,易,易於採取,監控,、,量測,、,分析,與,改善,等管理手,法,法(,i.e.,更著重於,作業流程,之,管理,、,改善,與,創新,)，比起,舊,舊版,ISO(,以條文為,導,導向)更,能,能有效監,督,督企業內,部,部各流程,之,之運作及,有,有效性,。,。,22,5.,System approachto mgmt(,管理,interrelatedprocesses,之系統管,理,理):,e.g.4,大,processes (mgmt,resource, production/service-provision,MAI,等)之有,效,效管理&,linkages,create,“,“synergy(,綜效)”&,integration(,整合),thewhole exceeds the sum oftheparts.,打破,functional &departmental barriers/silos/boundaries(viacommunication.):,打破藩籬(內牆及,外,外牆)!,GEs,“,“Boundaryless (,無界限),概,概念”!,6. Continualimprovement(,持續改善):,“,Good-Better-Best,”,”,“Better(Q) -Cheaper(C)-Faster(D)”,7. Factual approachto decisionmaking (,以事實/,資,資料為根,據,據之決策):,Clause 8,e.g.Asaying:,Ifyoucant measure it, you cantmanage it !,(,如果你不,能,能衡量它,，,，就無法,管,管理它!),e.g.Piles and pilesofrecordsgatheredbutsitthere to collect dust.,。,23,8. Mutuallybeneficial supplierrelationships (,互利之中,衛,衛體系關,係,係):,打,打破外,牆,牆!,Notstronglyincorporated inISO9001:2000,butin ISO 9004:2000.,但可以延,伸,伸看成,inter-departments/internal customers,之關係:,breakingthebarriers between departments.(,打破內,牆,牆!),e.g.,英航,將外包作,業,業發揮的,淋,淋漓盡致,；,； 企,業,業合併,是,是為了達,到,到預期之,綜效(,Synergy): 1+1, 2? What if,內鬥/內,耗,耗，勾心,鬥,鬥角而形,成,成空轉,?(,a story:, interviewee,反問,interviewer:,你要多少?結果,他,他被錄取,了,了!),以上八大,原,原則構成,ISO9000,系列標準,之,之基礎。,24,注意:,前,前3項(,Customerfocus,Leadership &Involvementofpeople),是屬於,softrequirements (harder toaudit!),* 21,世紀強調,顧客第,一,一，員工,第,第二，服,務,務第三，,老,老闆最後,的領導,觀,觀念。,TS 16949:2002NOTETheknowledge and use oftheeight quality management principlesreferred toinISO9000:2000 and ISO 9004:2000should be demonstrated and cascadedthroughtheorganizationbytopmanagement.,備註八項品質,管,管理原則,（,（參考,ISO 9000:2000,和,ISO 9004:2000,）,的知識和應,用,用，應由高,階,階管理階層,加,加以示範並,由,由上而下展,開,開至整個組,織,織。,25,FAQ:,ISO9001:1994,轉換,至,至,ISO9001:2000,會增,加,加很,多,多成,本,本嗎,？,？,答:,a),對於,一,一些,原,原先,QMS,之推,行,行就,很,很扎,實,實，,健,健全,之,之公,司,司(,e.g.,一些,體,體質,良,良好,之,之,High-techIndustry),而言,，,，不,是,是大,問,問題,。,。因,為,為這,些,些公,司,司一,開,開始,就,就都,很,很專,注,注於,流程,導,導向/方,式,式&,持續,改,改善,，,高階,管,管理,階,階層,參,參與,，,有,有很,好,好之,process,來瞭,解,解,客戶,需,需求,及,有,有效,監,監控,及,及量,測,測是,否,否符,合,合,客,戶,戶,需,需,求,求,，,，,甚,甚,至,至,將,將,其,其,結,結,合,合,至,至,有,有,效,效,之,之,品,質,質,目,目,標,標,及,及,客,戶,戶,滿,滿,意,意,度,度,管,管,理,理,.,。,。,26,b),但是對,於,於一些,平,平常就,欠,欠缺,流程導,向,向(,Process Focus),之公司,，,，可能,就,就有問,題,題。這,些,些公司,可,可能僅,有,有將,ISO9001:1994,之20,個,個條文,做,做成文,件,件，並,不,不真正,了,了解這20個,條,條文如,何,何和,作業流,程,程(,BusinessProcesses),之間之,連,連結及,交,交互作,用,用；換,言,言之，,他,他們沒,有,有真正,了,了解及,落,落實,clause4.1:,組織必,需,需先,管理其,流,流程,(,theorganization muststartmanagingits processes)。,同時，,他,他們距,離,離達到,上,上述,a),之水準,還,還有一,大,大段距,離,離.,。,。,Remarks:,許多,通,通過,ISO9001:1994,之公,司,司之,QMS,常被,詬,詬病,為,為,由,由20個,不,不怎,麼,麼相,關,關之,活,活動,之,之鬆,散,散結,合,合，,而,而不,是,是緊,密,密環,環,環相,扣,扣之,系,系統,性,性結,合,合/,管,管理,(,manyISO9001:1994compliantsystemswereactuallyaloosecollectionof20semirelatedactivitiesratherthanasystematicapproachtomanagement.),。,。,27,新版,ISO9001:2000,只剩,ISO9001,，,，,不像1994,年,年版,的,的有,分,分,ISO9001,ISO9002&ISO9003，,因此,需,需特,別,別注,意,意7.3,DesignandDevelopment(,設計,與,與開,發,發),有,有無,被,被,排外,(,exclusion),之問題。,Exclusion (,排外),ofISO9001:2000 requirements,“NotApplicable”duetothenature of an organization and its product:,由於組織,及,及其產品,之,之性質,(,nature),不同之關,係,係，可能,新,新的,ISO9001:2000,標準有某,些,些條文可,以,以不適用,，,，那麼這,些,些不適用,之,之情況可,以,以被考慮,當,當成排,外,外 (,exclusion)。,Where exclusionsaremade, claims ofconformityto thisInternational Standard are not acceptable unlessthese exclusions are limited toreqmtswithin clause 7,andsuch exclusionsdonotaffect the organizations ability, or responsibility, toprovideproductthat meetscustomerandapplicableregulatory reqmts.,28,該排外, (,exclusions),只限制適,用,用於條,文,文7(,clause 7) :,“,產品實現,ProductRealization”,之條文，,且,且該排,外,外不能,影,影響到組,織,織為供應,能,能符合客,戶,戶和法規,要,要求之產,品,品之該組,織,織之能,力,力 (,ability),或,責任(,responsibility).,和,QS-9000,觀念一致.,常見之,排,排外(,Exclusions):,7.3Design and Development,設計與,開,開發:,(,Major ARifQM addressesN/Afor,.),29,7.5.2 ValidationofProcesses (Special Processes),特殊製(流)程,7.5.3 IdentificationandTraceability,識別與,追,追溯,這個,clause,可能是,partially applicable,，,，,亦即 “,Identification”,部分是,applicable (,不能排外)，但如,果,果對組織,之,之產品而,言,言，並沒,有,有特定之,追,追溯要求,時,時，則,Traceability,可排外。,7.5.4 Customer Property,客戶財,產,產,假如客戶,提,提供原,始,始設計,給,給工廠製,造,造，此即,構,構成所謂,的,的智慧,財,財產(,IP:IntellectualProperty),而算是,客,客戶財產,，必需,納,納入組織,之,之,QMS,之中。(,Minor ARifQM addressesN/Afor,),7.6UseofMeasuring and Monitoring Devices,量測與,監,監控儀器,之,之使用(例如,一,一些服務,業,業不需用,到,到量具時,buthowabout,加油站,，,葬,x,社，,x,儀館?),30,Wheretheoverallresponsibilityfor,productrealization,belongstoanorganization,processoutsourcing(,某,些,些,“,“,流,流,程,程,”,”,外,外,包,包),isnotvalidjustificationforexclusion:,當,當,組,組,織,織,對,對,產,品,品,實,實,現,現,負,全,全,責,責,時,時,，,，,將,將,某,某,些,些,過,過,程,程/,流,流,程,程(,processes),外包,出,出去,並,並非,有,有效,之,之,排,排外,(,exclusions),之理,由,由。(參,閱,閱後,續,續之,AppriopriateControl,之,itemH,和,StrongerPurchasingControl,兩部,分,分之,詳,詳細,說,說明),Remarks:,假如,公,公司,將,將,design,委外,給,給沒,有,有通,過,過,ISO9000,之公,司,司時,Scope,為,TheManagementofsubcontracted(,或,outsourced)XXX(,產品,名,名稱),design.ThemanufactureofXXX(,產品,名,名稱),。,假使,是,是委,外,外給,通,通過,AccreditedISO9000,之公,司,司時,Scope,之寫,法,法可,以,以寫,成,成,ThedesignandmanufactureofXXX(,產品,名,名稱),。,Regulatory/CustomerPermissiontoexcludeapplicablerequirementsnotvalidjustification.:,法規,或,客戶,允許,可,可以,將,將某,些,些,該適,用,用,之條,文,文,排外,並,並非,有,有效,之,之,排,排外,理,由,由。,31,e.g.A,廠為,取,取得,ISO9002:1994,之一,生,生產,某,某種,riskclass,之醫,療,療器,材,材廠,，,，法,規,規並,沒,沒有,強,強制,要,要求,生,生產,此,此種,醫,醫療,器,器材,之,之製,造,造商,一,一定,要,要將,設計,管,管制,納入,其,其,QMS,之中,。,。在,挑,挑戰,ISO9001:2000Upgrade,時，,因,因,A,廠本,身,身確,實,實有,從,從事,此,此種,產,產品,之,之,設計,與,與開,發,發,活動,，,，而,且,且此,種,種活,動,動確,實,實也,會,會影,響,響其,符,符合,客,客戶,要,要求,之,之能,力,力(,theactivitydoesaffectitsabilitytomeetcustomerrequirements)，,因此,A,廠決,定,定不,將,將7.3(,DesignandDevelopment),排除,在,在,QMS,之外,。,。,認證,範,範圍(,ScopeofRegistration),可以,只,只包,含,含,部分,產,產品,(,limitedscope),32,DesignandDevelopment,看,IAFGuidance2.,假如,組,組織,對,對於,認,認証,範,範圍,之,之內,之,之產,品,品具,有,有設,計,計/,開,開發,責,責任(,designresponsible)，,並且,執,執行(,perform),該設,計,計/,開,開發(,design&development)，,或將,該,該設,計,計/,開,開發,外,外包(,委,委外,),出去(,outsource),執行,，,，那,麼,麼條,文,文7.3(,設,設計,和,和開,發,發),必,必,須,須納,入,入,品質,管,管理,系,系統,(,QMS),之內,。,。換,言,言之,，,，條,文,文7.3(,設,設計,與,與開,發,發),不,不,可,可以,排,排外,。,。,33,Designanddevelopment,ISO9000:2000definition(Clause3.4.4),Setofprocessesthattransforms,requirements,intospecified,characteristics,Distinguishingfeature,(Physical,sensory,behavioural,Temporal,ergonomic,functional),Needorexpectationthatisstated,generally implied orobligatory.,34,NOTE1 the terms,“,“design,”,” and “development”aresometimes used synonymouslyandsometimes used to definedifferent stages oftheoveralldesignanddevelopmentprocess.,e.g.software,治金業等,習,習慣用,development,這個字，,而,而不用,design,這個字。,Customer/regulatory/productrequirements:designinput(,客戶/法,規,規/產品,要,要求:設,計,計輸入),vs.productcharacteristics/specifications:design output(,產品特性/規格:,設,設計輸出),- 假如,組,組織沒有,被,被 (客,戶,戶) 提,供,供,產品特性,(,productcharacteristics),或產品規,格,格 (,productspecifications),用以規劃,其,其,產品實現,過,過程,(,productrealizationprocesses)，,並且組,織,織必須,根,根據,客戶或,法,法規要,求,求,(,customerand/orregulatorybody requirements),來定義(,define),這些產,品,品特性(或,product specifications)，,此意為,產品,設,設計與,開,開發(,product designanddevelopment) 。,35,-,簡言之，只,要,要看產品,規,規格 (,Product Spec.),制定者是,誰,誰即可很清,楚,楚釐清設計,責,責任及設,計,計是否可以,排,排外之問,題,題。,-Product Spec.(,產品規格),vs. Process Spec. (,製程規格),e.g.,電鍍廠/車,體,體塗裝烤漆,廠,廠之認証範,圍,圍 “,The (design and) provision ofelectro-plating(,或,painting)”,ISO/TS 16949:2002,The only permitted exclusionsfor this Technical Specification relateto 7.3 where the organizationis not responsible for productdesign and development.,Permittedexclusionsdo not includemanufacturingprocess design.(,製程設計不,可,可以被排外),36,附註:,i),傳統之設,計,計與開發,(,design anddevelopment),是針對有形,之,之產品,(,product)，,但亦適用於,服,服務,service (,無形之產品)。,e.g.,我看過,國泰人壽,之大幅廣告,寫,寫著,ISO 9002,認証，這樣,對,對嗎？,答:,Yes,假如認証範,圍,圍只是,國泰,一個,營業所, 負責拉,保,保險 ,收,收費 ,客,客服等,No,假如認証範,圍,圍是整個,國泰,集團之作業,meaning,有涵蓋新,保,保單(其,Service product),之 產品設,計,計與開發,ISO9001:19944.4,設計管制,37,ii),組織可以選,擇,擇將設計,與,與開發流程,(,design anddevelopment process),外包出去(,outsource),，,，,這種情況就,需,需符合,ISO 9001:2000,之,clause 4.1,之,“where anorganization choosesto outsource any processthataffects product conformity with requirements, theorganization shallensure controloversuchprocesses.Controlof such outsourced processes shallbe identified withintheQMS.,38,iii),一個組織不,一,一定對,QMS,所涵蓋範圍,之,之內之所有,產,產品都有設,計,計/開發責,任,任。,iv),雖然,原始設計,不,不屬於某一,組,組織，但該,組,組織可能有,責任及,權力來變,更,更產品規格,或,或特性。此,情,情況表示條,文,文,clause 7.3(Design and Development),之某些,子條文(,subclauses),可能不適用,，,，但不能將,整,整個,clause 7.3,完全排外。,e.g.OEM:Original Equipment Manufacturer,(,原始設備製,造,造商),ODM:Original DesignManufacturer (,原始設計製,造,造商),EMS:Electronics Manufacturing Service,(,電子製造服,務,務/電子代,工,工業):,台,台灣已是全,球,球之佼,佼者。,39,v) QS-90004.4,A supplieris defined asdesign-responsible if ithas the authority toesbablisha new, orchange anexistingproduct specification foranyproduct shippedto acustomer.Customerapprovalof adesign responsible suppliersproduct does not waive the supplier,s designresponsible status.:,對於交運給,客,客戶之,產品,而言，如果,該,該供應商具,有,有,權力,(,authority),來建立該(,新,新)產品之,規,規格，或變,更,更該產品之,現,現行規格，,均,均稱該供應,商,商具有,設計責任,(,design responsible)。,即使客戶核,准,准 (認可) 了具有,設,設計責任之,供,供應商之產,品,品 (,a design responsiblesuppliers product),也不能免除,該,該供應商之,設,設計責任。,40,FAQ:,本公司並沒,有,有,設計開發部,門,門,(,R&D),而且多年來,一,一直都是生,產,產非常成熟,之,之,UL,線種,SPT-1,和,SPT-2(,根據,UL 62,電線標準), 此情,況,況是否可將,ISO 9001:2000,之7.3(,設,設計和開發) 排外?,If not,在未來幾年, 我們,也,也可能無任,何,何新設計案!?,Ans:1.,問題不在有,無,無,R&D,部門之設立, 想一,想,想,product “characteristics”(distinguishingfeatures)/product specs(design output),是誰訂的?,UL62,電線標準只,告,告訴你一些,safety requirements(design input),它並沒有告,訴,訴你其他,non-safetyrequirements(e.g.,顏色、外觀,、,、花紋)! 如果,組,組織必需根,據,據客戶/,UL,安規要求(,customer/UL safety requirements:design input),來定義 (,define),這些線種之,產,產品特性/,規,規格 (,product characteristics/specs:design outpout),，,，,或稱 開,規,規格，則,該,該組織是有,從,從事 7.3 (產,品,品) 設計,與,與開發!,41,2.,想一想 ,7.3.3之,Design anddevelopment outputs,有那些規定:,The outputs ofdesign anddevelopment shall be providedin aformthatenables verification againstthe designanddevelopment input and shall beapprovedpriorto release.,Design anddevelopment outputsshall,a) meet the input requirementsfordesign anddevelopments,b) provideappropriate informationfor purchasing,production andforservice provision,c) containor reference product acceptance criteria, and,d) specifythecharacteristicsof the productthatareessentialfor its safe and proper use.,上述之,design outputs,是誰訂的? 如,果,果是組織,本,本身，那,麼,麼我們可,以,以說組,織,織俱有設,計,計責任/,能,能力，,不,不能將7.3排,外,外!,42,一,般,般,產,產,品,品,設,設,計,計,工,工,程,程,師,師,所,所,產,產,出,出,的,的,Productspecification,產,品,品,規,規,格,格(,designoutput),是,為,為,了,了,下,下,列,列,用,用,途,途:,採,購,購,、,、,生,生,產,產/,製,製,造,造,、,、,檢,檢,驗,驗,、,、,包,包,裝,裝,、,、,安,安,裝,裝,、,、,及,及,使,使,用,用,。,。,註:(,常,常,見,見,錯,錯,誤,誤),誤,誤,將,將,工,工,業,業,標,標,準,準/,規,規,格,格,，,，,安,安,規,規/,法,法,規,規,規,規,定,定,，,，,客,客,戶,戶,招,招,標,標,規,規,定,定,當,當,成,成,Productspecifications(designoutput),。,。,事,實,實,上,上,，,，,這,這,些,些,通,通,常,常,是,是,designinput,亦,即,即,customer/product/regulatoryrequirements!,43,3.,重,點,點:,簡,簡,單,單,的,的,設,設,計,計(,或,或,設,設,變,變),簡,簡,單,單,的,的7.3,管,管,制,制,簡,簡,單,單,的,的,設,設,計,計,記,記,錄,錄/,資,資,料,料,(,DesignRecords),i.e.DesignInputs(7.3.2),DesignReview(7.3.4),DesignVerification(7.3.5),DesignValidation(7.3.6),和,DesignChanges(7.3.7),都規,定,定要,保,保留,記,記錄,。,。經,驗,驗告,訴,訴我,們,們,一,一些,傳,傳統,中,中小