ISO9000-ISO16949-QS9000讲义

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,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,外顯知識,是指可,以,以有系統,的,的語言來,表,表示的知,識,識 (,e.g.,企業的內,部,部,ISO,文件&記,錄,錄等),，,， 內,隱,隱知識,則,則指無,法,法以正式,的,的方法表,達,達 及溝,通,通的知識,。,。(,e.g.,隱藏在個,別,別員工腦,袋,袋裡的專,門,門技術或,經,經驗)。,由於外顯,知,知識才能,被,被傳播、,擷,擷取和再,使,使用，因,此,此如何將,內隱知,識,識 轉,化,化成外,顯,顯知識,是,是企業或,個,個人知識,管,管理的重,要,要課題之,一,一，尤其,是,是對一些,知,知識型產,業,業，知識,型,型工作者,，,，高附加,價,價值製造,業,業。,3,知識管,理,理之終,極,極目的是,知識創,新,新創值:,實施知識,管,管理所倚,重,重的不是,資,資訊科技,，,，而是一,套,套鼓勵員,工,工不斷創,新,新創值的,制,制度與文,化,化，如讓,基,基層員工,參,參與研發,，,，允許工,作,作人員犯,錯,錯(但不,可,可第二次,犯,犯相同的,錯,錯)，其,對,對員工的,尊,尊重，使,得,得該公司,能,能得以從,知,知識管理,進,進入知識,創,創造的境,界,界，自然,能,能不斷的,創,創新。,組織不陷,入,入僵化的,做,做法，就,是,是在創新,的,的精神下,創,創造一個,環,環境，讓,企,企業內能,發,發生創造,性,性的摩擦,和,和建設性,的,的對立，,如,如此則可,有,有良性循,環,環產生，,企,企業有源,源,源不絕的,創,創新觀念,和,和行動，,使,使企業永,遠,遠具有競,爭,爭力。而,創,創新是必,須,須注意到,人,人文面，,才,才是成功,。,。,4,ISO/TS 16949:2002 6.2.2.4,之 :,Employeemotivationandempowerment(,員工激勵,與,與授/賦,權,權),Theorganizationshall havea process tomotivate employeesto achieve quality objectives, to make continualimprovements, and to createanenvironmentto promote innovation.Theprocessshall include the promotionof quality and technologicalawareness throughout the wholeorganization. (,組織必須,有,有一流程,來,來激勵員,工,工 ,以,以達成品,質,質目標, 進行,持,持續改善, 以,及,及建立一,個,個能鼓勵,創,創新之環,境,境。此流,程,程需包括,將,將品質及,科,科技意識,推,推廣至整,個,個組織內,。,。),5,Data(8.4),Information,Knowledge (is power):,ISO9004:2000Managementshould treat,data (8.4Analysisofdata) asa fundamental resourceforconversion toinformation and the continualdevelopmentof an organizations,knowledge, whichisessential for making factual decisions,(7,th,QualityManagement Principle-Factualapproachtodecisionmaking/Managementby (quality)Objective /CI/CA/PA) and can stimulate,innovation(,知識創新,e.g.7.3, Design& Development)。,6,創,新,新,:,並,並,非,非,指,指,技,技,術,術,研,研,發,發,和,和,知,知,識,識,本,本,身,身,，,，,而,而,是,是,指,指,取,取,得,得,和,和,應,應,用,用,知,知,識,識,和,和,技,技,術,術,能,能,將,將,其,其,轉,轉,變,變,為,為,市,市,場,場,價,價,值,值,的,的,能,能,力,力(,i.e.,市場價值,之,之創造)。,這,這種,市場價值,乃,乃經由,市場競爭,比,比較而來, 而其最,後,後之抉擇則,在,在於滿足顧,客,客需要的能,力,力(,i.e.,目前政府大,力,力推動之,Innovalue,創新價值,)。,郭台銘說，,對,對於一家公,司,司而言，創,新,新指的是速,度,度、彈性、,價,價格與品質,的,的更佳化。,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.,ISO9001:2000,organization-friendly,和,ISO14001,相容,品,質,質管,理,理系,統,統,(,QMS),和,作,作業,流,流程,(,BusinessProcesses),相結,合,合:,新,版,版,ISO9001focuseson,“,“howtomanageabusinesstoachieveplanned/desiredresults(i.e.effectiveness),notonindividualclauses,”,”,vs.,舊,版,版20個,條,條文:,“,“,Thesuppliershall,.,”,”,9,更強,調,調,持,持續,改,改善,和,客,戶,戶滿,意,意,幾乎是向,QS-9000,靠攏,強調高階,管,管理階層,之,之參與(,EmphasisonTopManagement ):,條文5,強調一張,証,証書涵蓋總,公,公司/旗下,多,多廠,之認証模式(,Emphasis on Corporate Registration/Certification):,更,cost& QMSeffective! UL,不會為了多,一,一些,income,而故意隱瞞,此,此點!,Beyond certificationtowards performanceimprovement.,10,New structure of thestandardsshould not oblige organizations tochange their systemdocumentationto matchthe structure of thestandards.,System documentationis uniqueto each organization.,Requirements from the oldISO9001:1994havebeeneither:,Maintained(Example-purchasing),Simplified(Example-calibration),Eliminated(Example-documentation),Structurechanges,11,Features of ISO9001:2000,Mostrequirements come from either:,8 QualityManagementPrinciples,1994version ofISO9001,ISO 14001:1996,QS-9000 (Automotiveindustry),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!),ISO 9001:1994 “Documentedprocedures evidenced byrecords”,ISO 9001:2000 “Defined and managedprocessesevidencedby 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,少,只剩九項,強,強制要求,和,和公司自,覺,覺有必要之,文,文件:,書面化之,品,品質政策, 品,質,質目標,品質手冊, 文,件,件管制,記錄管,制,制, ,內,內部稽核, 不良,品,品管制,矯正措,施,施和預,防,防措施,。,。,14,註:,Procedure(ISO9000:20003.4.5),Specifiedway to carry out anactivity or a process,NOTE1 procedures can bedocumentedor not.,NOTE2 When a procedure is documented, the term “written procedure” or,“,“documented procedure” is frequently used.The document that contains a procedure can becalled a,“,“proceduredocument”.,判定是否,符,符合規定: 彈性,更,更大 !,QMS drivenby quality policy,quality objectives and continuous improvementtargets (,由品質政,策,策, ,品,品質目標,及,及持續改,善,善目標來,驅,驅動品質,管,管理系統!),15,TL 9000 4.1.1 Quality Objectives -Objectives forquality shallinclude targetsforthe TL 9000 metricsdefined intheTL 9000 QualitySystem Metricshandbook.,註:,QMS,代表,Quality Management System, (,品質管理系,統,統)。,16,QMS,和 作業,流,流程,(,Business Processes),相結合.,:,:,所以,AR (,缺點,Action Request),如 “,The practice of,.isnotdocumented inprocedure”,是不能再開,的,的!,Flexible Requirements: ,是否符合規,定,定之彈性,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,方法/方,式,式,(,approaches/ways),*DOESNOTmeanassessorswillacceptless,objectiveevidenceofcompliance,(,上述,之,之意,涵,涵不,表,表示,assessors,將接,受,受更,少,少之,客,客觀,證,證據,就,就能,符,符合,要,要求!),17,Assessors,將需,更,更注,重,重以,是,否,否達,成,成組,織,織所,訂,訂定,之,之量,化,化之(,策,策略,性,性),目,目,標,標,來,來量,測,測,品,品質,管,管理,系,系統,(,QMS),之執,行,行效,果,果(,effectiveness).,-ISO9001:2000,之4,個,個,主,主要,流,流程(,processes),和一,般,般之,作,業,業流,程,程(,BusinessProcesses),相類,似,似.,*,Assessors,將,花,花,更,更,多,多,時,時,間,間,來,來,稽,稽,核,核,作,作,業,業,系,系,統,統,(,BusinessSystems),和,作,作,業,業,流,流,程,程,(,BusinessProcesses),因,因,大,大,部,部,分,分,公,公,司,司,均,均,將,將,品,品,質,質,目,目,標,標,(,QualityObjectives),和,營,營,業,業,目,目,標,標,(,BusinessObjectives),整,合,合,在,在,一,一,起,起.,e.g.QMS,和,上,上,市,市(,櫃,櫃),9,大,大,循,循,環,環,(,內,內,控,控,系,系,統,統),結,結,合,合,；,；,QMS,和,ERP/SCM/CRM,結,合,合(,物,物,流,流,，,，,金,金,流,流,，,，,資,資,訊,訊,流,流,零,零,庫,庫,存,存/,JIT,，,，,e,化/,M,化/,IT,技,術,術,之,之,應,應,用,用,),。,。,組,組,織,織,進,進,行,行,e,化/,M,化,必,必,會,會,導,導,致,致,作,作,業,業,流,流,程,程,，,，,工,工,作,作,模,模,式,式,之,之,改,改,變,變,！,！,18,*,ISO9001:2000,各,個,個,子,子,條,條,文,文,之,之,process(sub-,clauseprocess),之,執,執,行,行,效,效,果,果,將,將,被,被,用,用,來,來,決,決,定,定4,個,個,主,主,要,要,processes(,條文58),之,之執,行,行效果,。,。,八大品,質,質管理,原,原則(,eightquality mgmtprinciples),Topmgmt,應使用,下,下列八,大,大原則,來,來達到,績效,提,提昇,(,improvedperformance):,Customerfocus(,客戶導,向,向/以,客,客為尊/替客,戶,戶加值):,要先決,定,定客,戶,戶是,誰,誰？,e.g.,學校:,maybe,學生、,家,家長(出錢,的,的)，,將,將來的,僱,僱主(,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,確定,(,ensure,可以,delegation,授權,),有,有一,個,個,process,存在,用,用以,確,確定,組,組織,內,內之,人,人員,都,都知,道,道,客,客戶,需,需求,之,重,重要,性,性，,並,並且,要,要符,合,合,客,客戶,需,需求,7.2Customer-relatedprocess,7.2.3Customercommunication,8.2.1Customersatisfaction,e.g.,豐田,汽,汽車,及國,外,外一,些,些兒,童,童玩,具,具公,司,司之,讓,消,消費,者,者全,程,程參,與,與商,品,品開,發,發,讓,讓消,費,費者,成,成為,研,研發,團,團隊,之,之“,Customer-in”,概念,之,落,落實,。,。,20,Leadership(,領導,統,統御/領,導,導風,格,格):,e.g.,麥克,波,特,特,大師,主,主張,策,略,略競,爭,爭,，,，強,調,調,貫,貫徹,策,策略,的,的唯,一,一辦,法,法就,是,是要,有,有非,常,常強,的,的領,導,導！,clause5,的,TopMgmtInvolvement.,5.1Mgmtcommitment:Orgcan,thireaconsultanttowriteaprocedurefor(top)mgmtcommitment!,3.Involvementofpeople(,全員,參,參與),TL90004.1.1.C.1Mgmtwithexecutiveresponsibilityshoulddemonstratetheiractiveinvolvementinlong-andshort-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,向,向)更能有,效,效監督企業,內,內部各流程,之,之運作及有,效,效性。,22,5.,System approachto 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,管理 &,linkages,create “synergy(,綜效)”&,integration(,整合),the wholeexceeds the sumof the parts.,打破,functional& departmentalbarriers/silos/boundaries (via communication.):,打破藩籬(,內,內牆及外牆)!,GEs,“,“Boundaryless (,無界限)概,念,念”!,6. Continual improvement(,持續改善):,“,Good-Better-Best”,“Better(Q)-Cheaper(C)- Faster(D)”,7. Factualapproachto decision making (,以事實/資,料,料為根據之,決,決策):,Clause 8,e.g.A saying:,Ifyou cantmeasure it, youcant manage it !,(,如果你不能,衡,衡量它，就,無,無法管理它!),e.g.Pilesandpilesof records gatheredbutsit thereto collectdust,.,。,23,8. Mutually beneficial supplier relationships(,互利之中衛,體,體系關係): 打破,外,外牆!,Not strongly incorporatedin ISO 9001:2000, but inISO9004:2000.,但可以延伸,看,看成,inter-departments/internalcustomers,之,關,關,係,係:,breakingthebarriersbetweendepartments.(,打,破,破,內,內,牆,牆,!),e.g.,英,航,航,將,外,外,包,包,作,作,業,業,發,發,揮,揮,的,的,淋,淋,漓,漓,盡,盡,致,致,；,；,企,企,業,業,合,合,併,併,是,是,為,為,了,了,達,達,到,到,預,預,期,期,之,之,綜,綜,效,效,(,Synergy):1+1,2?Whatif,內,鬥,鬥/,內,內,耗,耗,，,，,勾,勾,心,心,鬥,鬥,角,角,而,而,形,形,成,成,空,空,轉,轉,?(,astory:,interviewee,反,問,問,interviewer:,你,要,要,多,多,少,少?,結,結,果,果,他,他,被,被,錄,錄,取,取,了,了!),以,上,上,八,八,大,大,原,原,則,則,構,構,成,成,ISO9000,系,列,列,標,標,準,準,之,之,基,基,礎,礎,。,。,24,注,意,意:,前,前3,項,項(,Customerfocus,Leadership&Involvementofpeople),是,屬,屬,於,於,softrequirements(hardertoaudit!),*21,世,紀,紀,強,強,調,調,顧,顧,客,客,第,第,一,一,，,，,員,員,工,工,第,第,二,二,，,，,服,服,務,務,第,第,三,三,，,，,老,老,闆,闆,最,最,後,後,的,的,領,領,導,導,觀,觀,念,念,。,。,TS16949:2002NOTETheknowledgeanduseoftheeightqualitymanagementprinciplesreferredtoinISO9000:2000andISO9004:2000shouldbedemonstratedandcascadedthroughtheorganizationbytopmanagement.,備,註,註八,項,項,品,品,質,質,管,管,理,理,原,原,則,則,（,（,參,參,考,考,ISO9000:2000,和,ISO9004:2000,）,的,知,知,識,識,和,和,應,應,用,用,，,，,應,應,由,由,高,高,階,階,管,管,理,理,階,階,層,層,加,加,以,以,示,示,範,範,並,並,由,由,上,上,而,而,下,下,展,展,開,開,至,至,整,整,個,個,組,組,織,織,。,。,25,FAQ:,ISO9001:1994,轉,換,換,至,至,ISO9001:2000,會,增,增,加,加,很,很,多,多,成,成,本,本,嗎,嗎,？,？,答:,a),對於一,些,些原先,QMS,之推行,就,就很扎,實,實，健,全,全之公,司,司 (,e.g.,一些體,質,質良好,之,之,High-techIndustry),而言，,不,不是大,問,問題。,因,因為這,些,些公司,一,一開始,就,就都很,專,專注於,流程導,向,向/方,式,式&,持續改,善,善，,高階管,理,理階層,參,參與,，,，有很,好,好之,process,來瞭解,客戶需,求,求及,有,有效監,控,控及量,測,測是否,符,符合,客戶需,求,求，,甚,甚至將,其,其結合,至,至有效,之,之,品質目,標,標及,客戶滿,意,意度,管,管理.。,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,過,過,ISO9001:1994,之公司,之,之,QMS,常被詬,病,病為,由,由20,個,個不怎,麼,麼相關,之,之活動,之,之鬆散,結,結合，,而,而不是,緊,緊密環,環,環相扣,之,之系統,性,性結合/管理,(,many ISO9001:1994compliant systemswereactuallya loose collectionof20semirelatedactivitiesratherthana systematicapproachtomanagement.)。,27,新版,ISO9001:2000,只剩,ISO9001,，,，,不像1994年版,的,的有分,ISO9001, ISO 9002 &ISO9003，,因此需特,別,別注意7.3,Design and Development (,設計與開,發,發)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,致 .,常見之,排外, (,Exclusions):,7.3Design andDevelopment,設計,與,與開發,:,(,MajorARifQMaddressesN/A for.),29,7.5.2Validation of Processes(SpecialProcesses),特殊,製,製(流)程,7.5.3IdentificationandTraceability,識別,與,與追溯,這個,clause,可能是,partiallyapplicable，,亦即,“,“,Identification”,部分是,applicable (,不能排,外,外)，,但,但如果,對,對組織,之,之產品,而,而言，,並,並沒有,特,特定之,追,追溯要,求,求時，,則,則,Traceability,可排外。,7.5.4CustomerProperty,客戶財產,假如客戶提,供,供原始設,計,計給工廠,製,製造，此即,構,構成所謂的,智慧財產,(,IP: Intellectual Property),而算是客,戶,戶財產，,必,必需納入組,織,織之,QMS,之中。(,MinorAR if QMaddressesN/A for),7.6Use of Measuring and Monitoring Devices,量測與監,控,控儀器之使,用,用 (例,如,如一些服務,業,業不需用到,量,量具時,but how about,加油站,，,葬,x,社，,x,儀館?),30,Wheretheoverall responsibility for,product realization,belongs toan organization, processoutsourcing (,某些 “流,程,程” 外包),is not valid justification forexclusion:,當組織對,產品實現,負全責時，,將,將某些過程/流程 (,processes),外包出去,並,並非有效,之,之排外(,exclusions),之理由。(,參,參閱後續之,Appriopriate Control,之,itemH,和,Stronger PurchasingControl,兩部分之詳,細,細說明),Remarks:,假如公司將,design,委外給沒有,通,通過,ISO 9000,之公司時,Scope,為,The Managementof subcontracted (,或,outsourced) XXX(,產品名稱),design. The manufactureof XXX (,產品名稱),。,假使是委外,給,給通過,AccreditedISO9000,之公司時,Scope,之寫法可以,寫,寫成,The designandmanufacture ofXXX (,產品名稱),。,Regulatory/CustomerPermissionto exclude applicable requirementsnotvalidjustification.:,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,認證範圍 (,Scope of Registration),可以只包含,部分產品,(,limited scope),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,generallyimpliedorobligatory.,34,NOTE1theterms,“,“design,”,”and,“,“development,”,”aresometimesusedsynonymouslyandsometimesusedtodefinedifferentstagesoftheoveralldesignanddevelopmentprocess.,e.g.software,治,金,金,業,業,等,等,習,習,慣,慣,用,用,development,這,個,個,字,字,，,，,而,而,不,不,用,用,design,這,個,個,字,字,。,。,Customer/regulatory/productrequirements:designinput(,客,戶,戶/,法,法,規,規/,產,產,品,品,要,要,求,求:,設,設,計,計,輸,輸,入,入),vs.productcharacteristics/specifications:designoutput(,產,品,品,特,特,性,性/,規,規,格,格:,設,設,計,計,輸,輸,出,出),-,假,假,如,如,組,組,織,織,沒,沒,有,有,被,被(,客,客,戶,戶),提,提,供,供,產,品,品,特,特,性,性,(,productcharacteristics),或,產,產,品,品,規,規,格,格(,productspecifications),用,以,以,規,規,劃,劃,其,其,產,品,品,實,實,現,現,過,過,程,程,(,productrealizationprocesses),，,，,並,且,且,組,組,織,織,必,必,須,須,根,根,據,據,客,戶,戶,或,或,法,法,規,規,要,要,求,求,(,customerand/orregulatorybodyrequirements),來,定,定,義,義(,define),這,些,些,產,產,品,品,特,特,性,性(,或,或,productspecifications),，,，,此,意,意,為,為,產,產,品,品,設,設,計,計,與,與,開,開,發,發,(,productdesignanddevelopment),。,。,35,-,簡,言,言,之,之,，,，,只,只,要,要,看,看,產,產,品,品,規,規,格,格(,ProductSpec.),制,定,定,者,者,是,是,誰,誰,即,即,可,可,很,很,清,清,楚,楚,釐,釐,清,清,設,設,計,計,責,責,任,任,及,及,設,設,計,計,是,是,否,否,可,可,以,以,排,排,外,外,之,之,問,問,題,題,。,。,-ProductSpec.(,產,品,品,規,規,格,格),vs.ProcessSpec.(,製,程,程,規,規,格,格),e.g.,電,鍍,鍍,廠,廠/,車,車,體,體,塗,塗,裝,裝,烤,烤,漆,漆,廠,廠,之,之,認,認,証,証,範,範,圍,圍,“,“,The(designand)provisionofelectro-plating(,或,painting),”,”,ISO/TS16949:2002,TheonlypermittedexclusionsforthisTechnicalSpecificationrelateto7.3wheretheorganizationisnotresponsibleforproductdesignanddevelopment.,Permittedexclusionsdonotincludemanufacturingprocessdesign.(,製,程,程,設,設,計,計,不,不,可,可,以,以,被,被,排,排,外,外),36,附,註,註:,i),傳,統,統,之,之,設,設,計,計,與,與,開,開,發,發,(,designanddevelopment),是針對,有,有形之,產品,(,product)，,但亦適,用,用於服,務,務,service (,無形之,產,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,沒有,設計開發,部,部門,(,R&D),而且多年,來,來一直都,是,是生產非,常,常成熟之,UL,線種,SPT-1,和,SPT-2(,根據,UL 62,電線標準) ,此,此情況是,否,否可將,ISO9001:2000,之7.3(設計和,開,開發),排,排外?,If not,在未來幾,年,年 ,我,我們也可,能,能無任何,新,新設計案!?,Ans:1.,問題不在,有,有無,R&D,部門之設,立,立 ,想,想一想,product,“,“characteristics,”,”(distinguishingfeatures)/product specs(designoutput),是誰訂的?,UL62,電線標準,只,只告訴你,一,一些,safety requirements(designinput) ,它並沒有,告,告訴你其,他,他,non-safety requirements(e.g.,顏色、外,觀,觀 、花,紋,紋)!,如,如果組,織,織必需根,據,據客戶/,UL,安規要求(,customer/ULsafety requirements:design input),來定義(,define),這些線種,之,之產品特,性,性/規格(,productcharacteristics/specs:designoutpout)，,或稱 ,開,開規格,，,，則該組,織,織是有從,事,事 7.3 (,產,產品),設,設計與開,發,發!,41,2.,想一想, 7.3.3之,Design and development outputs,有那些規,定,定:,Theoutputsof design and development shallbe providedin aform that enables verificationagainstthedesign and development inputandshall be approved priortorelease.,Design and development outputs shall,a) meettheinput requirements for design and developments,b)provideappropriateinformationforpurchasing,productionandforserviceprovision,c)containorreferenceproductacceptancecriteria,and,d) specifythecharacteristicsof the productthatareessentialfor its safe and proper use.,上述之,design outputs,是誰訂的?,如,如果是,組,組織本身，,那,那麼我們可,以,以說組織,俱,俱有設計責,任,任/能力,，,，不能將7.3排外!,42,一般產品設,計,計工程師所,產,產出的,Product specification,產品規格(,design output),是為了下列,用,用途:,採購、生產/製造、檢,驗,驗、包裝、,安,安裝、及使,用,用。,註:(常見,錯,錯誤)誤將,工,工業標準/,規,規格，安規/法規規定,，,，客戶招標,規,規定當成,Product specifications (designoutput)。,事實上，這,些,些通常是,design input,亦即,customer/product/regulatory requirements!,43,3.,重點: 簡,單,單的設計(,或,或設變),簡,簡單的7.3管制,簡,簡單,的,的設計記,錄,錄/資料(,Design Records), i.e. Design Inputs(7.3.2), DesignReview(7.3.4),Design Verification(7.3.5), DesignValidation(7.3.6),和,Design Changes(7.3.7),都規定要保,留,留記錄。經,驗,驗告訴我們, 一些,傳,傳統中小企,業,業事實上有,開規格,生,生產