質(zhì)量管理系統(tǒng)QMS推行手冊(cè)

1、1質(zhì)量管理系統(tǒng)/QMS推行手冊(cè)2Course Objectives 也算是知識(shí)管理( Knowledge Management) 當(dāng)中的一種知識(shí)呈現(xiàn)/ 知識(shí)成文化(Knowledge Representation): 將內(nèi)隱知識(shí)(Implicit Knowledge)成文化、外化，成 為外顯知識(shí)(Explicit Knowledge) , 再和大家分享 (Knowledge Sharing)! 企業(yè)知識(shí)乃指能有效解決問(wèn)題的方法及資訊，又可分 為外顯知識(shí)及內(nèi)隱知識(shí)。3說(shuō)明:外顯知識(shí)是指可以有系統(tǒng)的語(yǔ)言來(lái)表示的知識(shí) (e.g. 企業(yè)的內(nèi)部 ISO 文件&記錄等)， 內(nèi)隱知識(shí) 則指無(wú)法以正式的方法表

2、達(dá) 及溝通的知識(shí)。(e.g.隱藏在個(gè)別員工腦袋里的專(zhuān)門(mén)技術(shù)或經(jīng)驗(yàn))。由于外顯知識(shí)才能被傳播、汲取和再使用，因此如何將內(nèi)隱知識(shí) 轉(zhuǎn)化成外顯知識(shí)是企業(yè)或個(gè)人知識(shí)管理的重要課題之一，尤其是對(duì)一些知識(shí)型產(chǎn)業(yè)，知識(shí)型工作者，高附加價(jià)值制造業(yè)。4知識(shí)管理之終極目的是知識(shí)創(chuàng)新創(chuàng)值:實(shí)施知識(shí)管理所倚重的不是資訊科技，而是一套鼓勵(lì)員工不斷創(chuàng)新創(chuàng)值的制度與文化，如讓基層員工參與研發(fā)，允許工作人員犯錯(cuò)(但不可第二次犯相同的錯(cuò))，其對(duì)員工的尊重，使得該公司能得以從知識(shí)管理進(jìn)入知識(shí)創(chuàng)造的境界，自然能不斷的創(chuàng)新。組織不陷入僵化的做法，就是在創(chuàng)新的精神下創(chuàng)造一個(gè)環(huán)境，讓企業(yè)內(nèi)能發(fā)生創(chuàng)造性的摩擦和建設(shè)性的對(duì)立，如此則可有良性

3、循環(huán)產(chǎn)生，企業(yè)有源源不絕的創(chuàng)新觀(guān)念和行動(dòng)，使企業(yè)永遠(yuǎn)具有競(jìng)爭(zhēng)力。而創(chuàng)新是必須注意到人文面，才是成功。5ISO/TS 16949:2002 之 :Employee motivation and empowerment (員工激勵(lì)與授/賦權(quán))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 pr

4、ocess shall include the promotion of quality and technological awareness throughout the whole organization. (組織必須有一流程來(lái)激勵(lì)員工 , 以達(dá)成質(zhì)量目標(biāo) , 進(jìn)行持續(xù)改善 , 以及建立一個(gè)能鼓勵(lì)創(chuàng)新之環(huán)境。此流程需包括將質(zhì)量及科技意識(shí)推廣至整個(gè)組織內(nèi) 。)6Data (8.4) Information Knowledge (is power):ISO 9004:2000 Management should treat data ( 8.4 Analysis of data) as a

5、 fundamental resource for conversion to information and the continual development of an organizations 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 inn

6、ovation(知識(shí)創(chuàng)新e.g. 7.3 Design & Development)。7創(chuàng)新: 并非指技術(shù)研發(fā)和知識(shí)本身，而是指取得和應(yīng)用知識(shí)和技術(shù)能將其轉(zhuǎn)變?yōu)槭袌?chǎng)價(jià)值的能力( i.e. 市場(chǎng)價(jià)值之創(chuàng)造)。這種市場(chǎng)價(jià)值乃經(jīng)由市場(chǎng)競(jìng)爭(zhēng)比較而來(lái) , 而其最后之抉擇則在于滿(mǎn)足顧客需要的能力( i.e. 目前政府大力推動(dòng)之Innovalue 創(chuàng)新價(jià)值 )。郭臺(tái)銘說(shuō)，對(duì)于一家公司而言，創(chuàng)新指的是速度、彈性、價(jià)格與質(zhì)量的更佳化。8企業(yè)要靠什么來(lái)創(chuàng)造價(jià)值?行銷(xiāo)( 即了解與掌握顧客的需求 Input)與 創(chuàng)新(即為顧客提出有效的解決方法 Output): Process approach!個(gè)人覺(jué)得 Learn

7、ing 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 為何有新版 ISO 9001:2000? 目的? 應(yīng)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(yè) (ISO 9001:1994 年版傾向于制造業(yè)之用) 更簡(jiǎn)單易懂 1994年版20個(gè)條文之問(wèn)題: ISO

8、 9001:1994auditor-friendly (easy to audit but difficult for org.)vs. ISO 9001:2000 organization-friendly 和 ISO 14001 相容 質(zhì)量管理系統(tǒng) (QMS) 和作業(yè)流程 (Business Processes) 相結(jié)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.

9、 舊版20個(gè)條文: “The supplier shall.” 910更強(qiáng)調(diào) 持續(xù)改善 和 客戶(hù)滿(mǎn)意 幾乎是向 QS-9000 靠攏強(qiáng)調(diào)高階管理階層之參與 (Emphasis on Top Management ): 條文5強(qiáng)調(diào)一張證書(shū)涵蓋總公司/旗下多廠(chǎng)之認(rèn)證模式 (Emphasis on Corporate Registration/Certification): 更c(diǎn)ost & QMS effective! UL不會(huì)為了多一些income而故意隱瞞此點(diǎn)! Beyond certification towards performance improvement.11New structur

10、e 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)

11、Eliminated (Example-documentation)Structure changes12Features of ISO 9001:2000Most requirements come from either:8 Quality Management Principles1994 version of ISO 9001ISO 14001:1996QS-9000 (Automotive industry)13Single requirements standard (no more ISO 9002/3) Need for clear scope statementsClause

12、 1.2 “Application” (ISO/TC 176 Guidance Document + IAF Communique)Special significance of “Design & Development”P(pán)rocess approach and PDCAComparison (Maybe a little unfair on ISO 9001:1994!)ISO 9001:1994 “Documented procedures evidenced by records”ISO 9001:2000 “Defined and managed processes evidence

13、d by results”新版 ISO 9001:2000 審核方式 (AssessmentPhilosophy) 有那些變更? 文件化要求大幅減少 只剩九項(xiàng)強(qiáng)制要求和公司自覺(jué)有必要之文件: 書(shū)面化之質(zhì)量政策 , 質(zhì)量目標(biāo)質(zhì)量手冊(cè), 文件管制, 記錄管制, 內(nèi)部審核, 不良品管制, 矯正措施和預(yù)防措施 。1415注: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 p

14、rocedure 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(guī)定 : 彈性更大 ! QMS driven by quality policy, quality objectives and continuous improvement targets (由質(zhì)量政策, 質(zhì)量目標(biāo)及持續(xù)改善目標(biāo)來(lái)驅(qū)動(dòng)質(zhì)

15、量管理系統(tǒng)!)16TL 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.注: QMS代表 Quality Management System (質(zhì)量管理系統(tǒng))。 QMS 和 作業(yè)流程 (Business Processes) 相結(jié)合.:所以, AR (缺點(diǎn)Action Request) 如 “The practice of .is n

16、ot documented in procedure” 是不能再開(kāi)的! Flexible Requirements: 是否符合規(guī)定之彈性更大!* Assessors 更被挑戰(zhàn)要去接受各式各樣能符合規(guī) 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(guān)證據(jù)就能符合要求!)17Assessors 將需更注重以是否達(dá)成組織所訂定之量化之 (策略性) 目標(biāo)來(lái)量測(cè)質(zhì)量管理系統(tǒng) (Q

17、MS) 之執(zhí)行效果 (effectiveness).- ISO 9001: 2000 之4 個(gè)主要流程 (processes) 和一般之作業(yè)流程 (Business Processes) 相類(lèi)似.* Assessors 將花更多時(shí)間來(lái)審核作業(yè)系統(tǒng)(Business Systems) 和作業(yè)流程 (Business Processes), 因大部分公司均將質(zhì)量目標(biāo) (Quality Objectives) 和 營(yíng)業(yè)目標(biāo) (Business Objectives) 整合在 一起. e.g. QMS和上市 (柜) 9大循環(huán) (內(nèi)控系統(tǒng)) 結(jié)合；QMS和 ERP/SCM/CRM 結(jié)合 (物流，金流，資

18、訊流零庫(kù)存/JIT，e化/M化/IT技術(shù)之應(yīng)用)。組織進(jìn)行e化/M化必會(huì)導(dǎo)致作業(yè)流程 ， 工作模式之改變！ 1819* ISO 9001:2000 各個(gè)子條文之process (sub- clause process) 之執(zhí)行效果將被用來(lái)決定4 個(gè)主要 processes (條文58) 之執(zhí)行效果。八大質(zhì)量管理原則(eight quality mgmt principles)Top mgmt 應(yīng)使用下列八大原則來(lái)達(dá)到績(jī)效提升(improved performance):Customer focus (客戶(hù)導(dǎo)向/以客為尊/替客戶(hù)加值): 要先決定客戶(hù)是誰(shuí)？ e.g. 學(xué)校: maybe 學(xué)生、家

19、長(zhǎng) (出錢(qián)的)，將來(lái)的雇主 (process out之使用者)，繳稅之community社區(qū)大眾 (公立學(xué)校)。 Clause 5.2 - Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction.20Remarks: 并不表示Top Mgmt需要親自參與合約/訂單審查。重點(diǎn)是Top Mgmt要確定(ensure可以delegation授權(quán))有一個(gè)process存在用以確定組織內(nèi)之人員都知道客戶(hù)

20、需求之重要性，并且要符合客戶(hù)需求7.2 Customer-related process7.2.3 Customer communication8.2.1 Customer satisfactione.g. 豐田汽車(chē)及國(guó)外一些兒童玩具公司之讓消費(fèi)者全程參與商品開(kāi)發(fā)讓消費(fèi)者成為研發(fā)團(tuán)隊(duì)之“ Customer-in”概念之落實(shí)。21Leadership (領(lǐng)導(dǎo)統(tǒng)御/領(lǐng)導(dǎo)風(fēng)格):e.g. 麥克波特大師主張策略競(jìng)爭(zhēng)，強(qiáng)調(diào)貫徹策略的唯一辦法就是要有非常強(qiáng)的領(lǐng)導(dǎo)！clause 5的Top Mgmt Involvement. 5.1 Mgmt commitment: Org cant hire a cons

21、ultant 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(dòng)絕非只是QA之責(zé)任224. Process approach 流程(

22、過(guò)程)導(dǎo)向或方式: 質(zhì)量看得見(jiàn)，過(guò)程是關(guān)鍵！e.g. 組織進(jìn)行e化/M化(Mobilize化: 行動(dòng)商務(wù)M Commerce)改變作業(yè)流程 也是一種C.I.ISO 9001: 2000版與舊版ISO 最大不同處在于新版是以流程為導(dǎo)向的質(zhì)量管理系統(tǒng)，使管理者易于采取監(jiān)控、量測(cè)、分析與改善等管理手法( i.e.更著重于作業(yè)流程之管理、改善與創(chuàng)新)，比起舊版ISO(以條文為導(dǎo)向)更能有效監(jiān)督企業(yè)內(nèi)部各流程之運(yùn)作及有效性。235. System approach to mgmt (管理 interrelated processes之系統(tǒng)管理): e.g. 4 大 processes (mgmt, re

23、source, production/service-provision, MAI等)之有效管理 & linkagescreate “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(nèi)墻及外墻)! GEs “Boundaryless (無(wú)界限)概念”!6. Continual improvement (持續(xù)改善):“Good-Better-Be

24、st”“Better(Q) -Cheaper(C)- Faster(D)”7. Factual approach to decision making (以事實(shí)/資料為根據(jù)之決策): Clause 8e.g. A saying: If you cant measure it, you cant manage it ! (如果你不能衡量它，就無(wú)法管理它!)e.g. Piles and piles of records gathered but sit there to collect dust.。248. Mutually beneficial supplier relationships (互

25、利之中衛(wèi)體系關(guān)系): 打破外墻!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(guān)系: breaking the barriers between departments.(打破內(nèi)墻!) e.g. 英航將外包作業(yè)發(fā)揮的淋漓盡致； 企業(yè)合并是為了達(dá)到預(yù)期之綜效(Synergy): 1+1 2 ? What if 內(nèi)斗/內(nèi)耗，勾心斗角而形成空轉(zhuǎn)? (a story: interviewee 反問(wèn) interviewer:你要多

26、少?結(jié)果他被錄取了!)以上八大原則構(gòu)成 ISO 9000系列標(biāo)準(zhǔn)之基楚。25注意: 前3項(xiàng)(Customer focus, Leadership & Involvement of people)是屬于soft requirements (harder to audit!)* 21世紀(jì)強(qiáng)調(diào)顧客第一，員工第二，服務(wù)第三，老板最后的領(lǐng)導(dǎo)觀(guān)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

27、should be demonstrated and cascaded through the organization by top management. 備注 八項(xiàng)質(zhì)量管理原則（參考ISO 9000:2000和ISO 9004:2000）的知識(shí)和應(yīng)用，應(yīng)由高階管理階層加以示范并由上而下展開(kāi)至整個(gè)組織。 26FAQ: ISO 9001:1994轉(zhuǎn)換至ISO 9001:2000會(huì)增加很多成本嗎？答: a)對(duì)于一些原先QMS之推行就很扎實(shí)，健全之公司 (e.g. 一些體質(zhì)良好之High-tech Industry)而言，不是大問(wèn)題。因?yàn)檫@些公司一開(kāi)始就都很專(zhuān)注于流程導(dǎo)向/方式& 持續(xù)改善，高階

28、管理階層參與，有很好之process來(lái)了解客戶(hù)需求及有效監(jiān)控及量測(cè)是否符合客戶(hù)需求，甚至將其結(jié)合至有效之質(zhì)量目標(biāo)及客戶(hù)滿(mǎn)意度管理.。27b) 但是對(duì)于一些平常就欠缺流程導(dǎo)向(Process Focus) 之公司，可能就有問(wèn)題。這些公司可能僅有將ISO 9001:1994之20個(gè)條文做成文件，并不真正了解這20個(gè)條文如何和作業(yè)流程(Business Processes)之間之連結(jié)及交互作用；換言之，他們沒(méi)有真正了解及落實(shí)clause 4.1: 組織必需先管理其流程(the organization must start managing its processes)。同時(shí)，他們距離達(dá)到上述 a)

29、之水準(zhǔn)還有一大段距離.。Remarks: 許多通過(guò)ISO 9001:1994之公司之QMS常被詬病為由20個(gè)不怎么相關(guān)之活動(dòng)之松散結(jié)合，而不是緊密環(huán)環(huán)相扣之系統(tǒng)性結(jié)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.)。新版ISO 9001:2000只剩ISO 9001，不像1994年版的有分ISO 9001, ISO 9002 & ISO 90

30、03，因此需特別注意7.3 Design and Development (設(shè)計(jì)與開(kāi)發(fā))有無(wú)被排外(exclusion)之問(wèn)題。Exclusion (排外) of ISO 9001:2000 requirements“Not Applicable” due to the nature of an organization and its product: 由于組織及其產(chǎn)品之性質(zhì) (nature) 不同之關(guān)系，可能新的ISO 9001:2000標(biāo)準(zhǔn)有某些條文可以不適用，那么這些不適用之情況可以被考處當(dāng)成排外 (exclusion)。Where exclusions are made, claim

31、s 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.2829該排外 (exclusions

32、) 只限制適用于條文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(hù)和法規(guī)要求之產(chǎn)品之該組織之能力 (ability) 或責(zé)任 (responsibility).和 QS-9000 觀(guān)念一致 . 常見(jiàn)之排外 (Exclusions) : 7.3 Design and Development 設(shè)計(jì)與開(kāi)發(fā):(Major AR if QM addresses N/A for.)307.5.2 Validation of Processes (Special Processes) 特殊制(流)程7.5.3 Identifi

33、cation 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，并沒(méi)有特定之追溯要求時(shí)，則Traceability可排外。7.5.4 Customer Property 客戶(hù)財(cái)產(chǎn) 假如客戶(hù)提供原始設(shè)計(jì)給工廠(chǎng)制造，此即構(gòu)成所謂的智慧財(cái)產(chǎn)(IP: Intellectual Property) 而算是客戶(hù)財(cái)產(chǎn)，必需納入組織之QMS之中。(Minor AR if QM addresses N/A for)7.6 Use of Measurin

34、g and Monitoring Devices 量測(cè)與監(jiān)控儀器之使用 (例如一些服務(wù)業(yè)不需用到量具時(shí), but how about加油站，葬x社，x儀館?)31Where 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(dāng)組織對(duì)產(chǎn)品實(shí)現(xiàn)負(fù)全責(zé)時(shí)，將某些過(guò)程/流程 (processes) 外包出去 并非有效之排外 (exclusions)

35、 之理由。(參閱后續(xù)之Appriopriate Control之item H 和 Stronger Purchasing Control兩部分之詳細(xì)說(shuō)明)Remarks: 假如公司將 design 委外給沒(méi)有通過(guò) ISO 9000 之公司時(shí), Scope為T(mén)he Management of subcontracted (或outsourced) XXX (產(chǎn)品名稱(chēng)) design. The manufacture of XXX (產(chǎn)品名稱(chēng)) 。假使是委外給通過(guò) Accredited ISO 9000之公司時(shí) , Scope 之寫(xiě)法可以寫(xiě)成The design and manufacture o

36、f XXX (產(chǎn)品名稱(chēng)) 。Regulatory/Customer Permission to exclude applicable requirements not valid justification.: 法規(guī)或客戶(hù)允許可以將某些該適用之條文排外 并非有效之排外理由。32e.g. A廠(chǎng)為取得ISO 9002:1994之一生產(chǎn)某種risk class之醫(yī)療器材廠(chǎng)，法規(guī)并沒(méi)有強(qiáng)制要求生產(chǎn)此種醫(yī)療器材之制造商一定要將設(shè)計(jì)管制納入其QMS之中。在挑戰(zhàn)ISO 9001:2000 Upgrade時(shí)，因A廠(chǎng)本身確實(shí)有從事此種產(chǎn)品之設(shè)計(jì)與開(kāi)發(fā)活動(dòng)，而且此種活動(dòng)確實(shí)也會(huì)影響其符合客戶(hù)要求之能力 (the

37、activity does affect its ability to meet customer requirements)，因此A廠(chǎng)決定不將7.3 (Design and Development) 排除在QMS之外。認(rèn)證范圍 (Scope of Registration) 可以只包含部分產(chǎn)品(limited scope)33Design and Development 看 IAF Guidance 2.假如組織對(duì)于認(rèn)證范圍之內(nèi)之產(chǎn)品具有設(shè)計(jì)/開(kāi)發(fā)責(zé)任(design responsible)，并且執(zhí)行 (perform) 該設(shè)計(jì)/開(kāi)發(fā) (design & development)，或?qū)⒃撛O(shè)計(jì)

38、/開(kāi)發(fā)外包 (委外) 出去(outsource) 執(zhí)行，那么條文7.3 (設(shè)計(jì)和開(kāi)發(fā)) 必須納入質(zhì)量管理系統(tǒng) (QMS) 之內(nèi)。換言之，條文7.3 (設(shè)計(jì)與開(kāi)發(fā)) 不可以排外。34Design and developmentISO 9000:2000 definition (Clause 3.4.4)Set of processes that transforms requirements into specified characteristicsDistinguishing feature(Physical, sensory, behavioural,Temporal, ergonomic

39、, functional)Need or expectation that is stated, generally implied or obligatory.35NOTE 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(yè)等習(xí)慣用development這個(gè)字，而不用design這個(gè)字

40、。Customer/regulatory/product requirements:design input (客戶(hù)/法規(guī)/產(chǎn)品要求:設(shè)計(jì)輸入) vs. product characteristics/specifications:design output(產(chǎn)品特性/規(guī)格:設(shè)計(jì)輸出)- 假如組織沒(méi)有被 (客戶(hù)) 提供產(chǎn)品特性 (product characteristics) 或產(chǎn)品規(guī)格 (product specifications) 用以規(guī)劃其產(chǎn)品實(shí)現(xiàn)過(guò)程 (product realization processes)，并且組織必須根據(jù)客戶(hù)或法規(guī)要求 (customer and/or r

41、egulatory body requirements) 來(lái)定義 (define) 這些產(chǎn)品特性 (或product specifications)，此意為產(chǎn)品設(shè)計(jì)與開(kāi)發(fā)(product design and development) 。36-簡(jiǎn)言之，只要看產(chǎn)品規(guī)格 (Product Spec.) 制定者是誰(shuí)即可很清楚厘清設(shè)計(jì)責(zé)任及設(shè)計(jì)是否可以排外之問(wèn)題。-Product Spec. (產(chǎn)品規(guī)格) vs. Process Spec. (制程規(guī)格) e.g. 電鍍廠(chǎng)/車(chē)體涂裝烤漆廠(chǎng)之認(rèn)證范圍 “The (design and) provision of electro-plating (或pai

42、nting)”ISO/TS 16949:2002The 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. (制程設(shè)計(jì)不可以被排外)37附注:i) 傳統(tǒng)之設(shè)計(jì)與開(kāi)發(fā) (design and development) 是針

43、對(duì)有形之產(chǎn)品 (product)，但亦適用于服務(wù) service (無(wú)形之產(chǎn)品)。 e.g. 我看過(guò)國(guó)泰人壽之大幅廣告寫(xiě)著ISO 9002認(rèn)證，這樣對(duì)嗎？答: Yes, 假如認(rèn)證范圍只是國(guó)泰一個(gè)營(yíng)業(yè)所 , 負(fù)責(zé)拉保險(xiǎn) , 收費(fèi) , 客服等 No, 假如認(rèn)證范圍是整個(gè)國(guó)泰集團(tuán)之作業(yè) meaning 有涵蓋新保單(其 Service product) 之 產(chǎn)品設(shè)計(jì)與開(kāi)發(fā)ISO 9001: 1994 4.4 設(shè)計(jì)管制38ii) 組織可以選擇將設(shè)計(jì)與開(kāi)發(fā)流程 (design and development process) 外包出去 (outsource)，這種情況就需符合ISO 9001:2000之

44、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.39iii) 一個(gè)組織不一定對(duì)QMS所涵蓋范圍之內(nèi)之所有產(chǎn)品都有設(shè)計(jì)/開(kāi)發(fā)責(zé)任。iv) 雖然原始設(shè)

45、計(jì)不屬于某一組織，但該組織可能有責(zé)任及權(quán)力來(lái)變更產(chǎn)品規(guī)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(gè)clause 7.3完全排外。e.g.OEM: Original Equipment Manufacturer (原始設(shè)備制造商)ODM: Original Design Manufacturer (原始設(shè)計(jì)制造商) EMS: Electronics Manufacturing Service (電子制造服務(wù)/電子代工業(yè)): 臺(tái)灣已是全球之佼 佼者。 40v) QS-9000 4.4

46、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(duì)于交運(yùn)給客戶(hù)之產(chǎn)品而言，

47、如果該供應(yīng)商具有權(quán)力 (authority) 來(lái)建立該(新)產(chǎn)品之規(guī)格，或變更該產(chǎn)品之現(xiàn)行規(guī)格，均稱(chēng)該供應(yīng)商具有設(shè)計(jì)責(zé)任 (design responsible)。 即使客戶(hù)核準(zhǔn) (認(rèn)可) 了具有設(shè)計(jì)責(zé)任之供應(yīng)商之產(chǎn)品 (a design responsible suppliers product) 也不能免除該供應(yīng)商之設(shè)計(jì)責(zé)任。41 FAQ: 本公司并沒(méi)有設(shè)計(jì)開(kāi)發(fā)部門(mén)(R&D) , 而且多年來(lái)一直都是生產(chǎn)非常成熟之UL線(xiàn)種SPT-1和 SPT-2(根據(jù)UL 62電線(xiàn)標(biāo)準(zhǔn)) , 此情況是否可將ISO 9001:2000之7.3(設(shè)計(jì)和開(kāi)發(fā)) 排外? If not, 在未來(lái)幾年 , 我們也可能無(wú)

48、任何新設(shè)計(jì)案!?Ans: 1. 問(wèn)題不在有無(wú)R&D部門(mén)之設(shè)立 , 想一想 product “characteristics”(distinguishing features)/product specs (design output)是誰(shuí)訂的? UL62 電線(xiàn)標(biāo)準(zhǔn)只告訴你一些safety requirements (design input) , 它并沒(méi)有告訴你其他non-safety requirements(e.g. 顏色、外觀(guān) 、花紋)! 如果組織必需根據(jù)客戶(hù)/UL安規(guī)要求 (customer/UL safety requirements:design input) 來(lái)定義 (defin

49、e) 這些線(xiàn)種之產(chǎn)品特性/規(guī)格 (product characteristics/specs:design outpout)，或稱(chēng) 開(kāi)規(guī)格，則該組織是有從事 7.3 (產(chǎn)品) 設(shè)計(jì)與開(kāi)發(fā)! 422. 想一想 , 7.3.3之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 approv

50、ed prior to release. Design and development outputs shalla) 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, andd) specify the characteristics of the pr

51、oduct that are essential for its safe and proper use.上述之 design outputs是誰(shuí)訂的? 如果是組織本身，那么我們可以說(shuō)組織俱有設(shè)計(jì)責(zé)任/能力，不能將 7.3排外!43一般產(chǎn)品設(shè)計(jì)工程師所產(chǎn)出的 Product specification產(chǎn)品規(guī)格(design output)是為了下列用途: 采購(gòu)、生產(chǎn)/制造、檢驗(yàn)、包裝、安裝、及使用。注:(常見(jiàn)錯(cuò)誤)誤將工業(yè)標(biāo)準(zhǔn)/規(guī)格，安規(guī)/法規(guī)規(guī)定，客戶(hù)招標(biāo)規(guī)定當(dāng)成 Product specifications (design output)。事實(shí)上，這些通常是design input亦即 c

52、ustomer/product/regulatory requirements!443.重點(diǎn): 簡(jiǎn)單的設(shè)計(jì)(或設(shè)變) 簡(jiǎn)單的7.3管制 簡(jiǎn)單的設(shè)計(jì)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(guī)定要保留記錄。經(jīng)驗(yàn)告訴我們 , 一些傳統(tǒng)中小企業(yè)事實(shí)上有開(kāi)規(guī)格生產(chǎn) , 但較不習(xí)于保留設(shè)計(jì)記錄。 454. 審核7.3之a(chǎn)uditor必須具備行業(yè)背景 , 了

53、解產(chǎn)品(特性) , 才能正確判斷是否有設(shè)計(jì)責(zé)任/排外。 據(jù)聞過(guò)去有些認(rèn)證公司 (Registrars) “鼓勵(lì)”有設(shè)計(jì)責(zé)任或有從事產(chǎn)品設(shè)計(jì)與開(kāi)發(fā)之公司去申請(qǐng)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 locat

54、ions. Assess the inputs/outputs using the process approach.46Activities (Steps) vs. Process (流程) vs. Process Approach (流程導(dǎo)向/方式)觀(guān)念 : 3 puts : Input -Throughput生產(chǎn)/Activities- Output Set of interrelated or interacting ACTIVITIES (steps) which transforms inputs into outputs. (將輸入轉(zhuǎn)換成輸出之交互作用之活動(dòng)) A PROCESS

55、 is any set of associated ACTIVITIES (steps) having inputs and generating outputs. (具有輸入 , 并且能產(chǎn)生輸出之任何交互作用之活動(dòng)稱(chēng)為一個(gè) “流程”process)47 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

56、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(gè)組織之有效運(yùn)作在于它需監(jiān)別及管理眾多之環(huán)環(huán)相扣之活動(dòng)。假如有一項(xiàng)活動(dòng) , 它使用了 資源 , 并且被管理, 以至于能將輸入轉(zhuǎn)換成輸出 , 我們稱(chēng)該項(xiàng)活動(dòng)為一過(guò)流程)。通常一個(gè)流程之輸出直接構(gòu)成了下一個(gè)流程之輸入。 The application of a system of processes

57、 within an organization, together with the identification and interactions and managing of these processes can be referred to as the “process approach”.那么 , 何謂流程導(dǎo)向/方式呢 ? 一個(gè)組織內(nèi)之所有流程之有系統(tǒng)之結(jié)合與運(yùn)作 , 加上對(duì)這些流程之監(jiān)別 , 交互作用及管理 , 稱(chēng)之為流程導(dǎo)向/方式。48 An advantage of the process approach is the ongoing control that it pr

58、ovides over the linkage between the individual processes within the system of processes, as well as their combination and interaction. 流程導(dǎo)向其中一個(gè)好處是 , 它能針對(duì)流程系統(tǒng)內(nèi)的各個(gè)流程之間之連結(jié) , 組合以及交互作用提供持續(xù)性之控管 。49When used within a QMS, such an approach emphasizes the importance of Understanding and fulfilling the requir

59、ements,The need to consider processes in terms of added value,Obtaining results of process performance and effectiveness, andContinual improvement of processes based on objective measurement. 如將流程導(dǎo)向應(yīng)用于質(zhì)量管理系統(tǒng) , 它能強(qiáng)化下列各項(xiàng)之重要性: 了解及滿(mǎn)足(符合)規(guī)定, 需要以是否能提高附加價(jià)值來(lái)思考流程 , 取得流程績(jī)效/表現(xiàn)及效果之結(jié)果 , 和 依據(jù)客觀(guān)量測(cè)而進(jìn)行之流程之持續(xù)改善。50PRO

60、CESS(“Set of interrelated or interacting activities”)INPUTOUTPUTMONITORING 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 T