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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)
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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」。
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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…。
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「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。
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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
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至整個組織內 。)
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 organization’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」(「知識創新」
e.g. 7.3– Design & Development)。
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「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。
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企業要靠什麼來創造價值?
1. 行銷( 即了解與掌握顧客的需求 Input)與
2. 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…
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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 9001:1994→auditor-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.
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Structure changes

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:
a) Maintained (Example-purchasing)
b) Simplified (Example-calibration)
c) Eliminated (Example-documentation)
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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)
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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”
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新版 ISO 9001:2000 稽核方式 (Assessment
Philosophy) 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」 。
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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」!)
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-※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)。
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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!)
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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！
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* ISO 9001:2000 各個「子條文」之process (subclause process) 之執行效果將被用來決定4 個主要 processes
(條文5~8) 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):
1. 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
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enhancing customer satisfaction.
Remarks: 並不表示Top Mgm’t需要親自參與「合
約/訂單審查」。重點是Top Mgm’t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。
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2. 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 can’t 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 longand 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
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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」。
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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)」! GE’s “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 can’t measure it, you can’t manage it !」
(如果你不能衡量它，就無法管理它!)
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e.g. Piles and piles of records gathered but sit there to collect dust….
。
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。
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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。
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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….。
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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
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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 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 organization’s ability, or
responsibility, to provide product that meets customer and
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applicable regulatory reqmts.

-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….)
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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…?)
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-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。
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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)
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-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。
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Design and development
ISO 9000:2000 definition (Clause 3.4.4)
Set of processes that transforms requirements into specified
characteristics
Distinguishing feature
Need or expectation that
is stated, generally
implied or obligatory.
(Physical, sensory,
behavioural,Temporal,
ergonomic, functional)
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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 supplier’s product does not
waive the supplier’s 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 supplier’s
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
41
開發」!
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 : Input -Throughput「生產/Activities」Output
• 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
46
為一個 “流程”「process」)
• 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
a)
b)
c)
d)
a)
b)
c)
d)
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
PROCEDURE
(“Specified way to carry out an activity or
a process” – may be documented or not)
INPUT
(Includes
Resources)
PROCESS
EFFECTIVENESS OF
PROCESS = ABILITY TO
ACHIEVE DESIRED
RESULTS (Focus of ISO
9001:2000)
OUTPUT
(“Set of interrelated or
interacting activities”)
MONITORING AND MEASUREMENT
OPPORTUNITIES
(Before, during and after the process)
Focus of TS-2: Effectiveness+Efficiency
PRODUCT
(“Result of a
process”)
EFFICIENCY OF
PROCESS=Results
acieved vs resources
used (Focus of ISO
9004:2000)
50
PDCA/PDSA (Plan-Do-Check-Act 或 Plan-Do-StudyAct: 計劃-執行-檢討-改善):
- Process approach 是遵循 PDCA管理/改善循環:
* Define the work (Plan 計劃)
* Execute the work (Do 執行)
* Measure the results (Check 檢討)
* Identify improvements (Act 改善): 含CI , CA & PA
ISO 9001:2000 更強調 “Plan” 和 “Act”, 此兩項是
多數公司較弱之地方。
(e.g. 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
Better (Q)
Cheaper (C)
Faster (D)
Act
●How to improve
Next time?
Check
●Did things happen
according to plan?
Plan
“The
objective w/o
method is
useless”
●What to do ?
●(“Objective”)
●How to do it?
●(“Procedure/method”)
Do
●Do what was planned
Check:
“Monitor and measure processes and product against policies,
52
objective and requirements for the product and report the results.
PDCA vs. Process Approach/Interaction
E
X
T
E
R
N
A
L
A
P
C
D
Output A
Input A
Input E
Output E
PROCESS E
PROCESS A
A
P
C
D
Input C
PROCESS C
A
P
C
D
Input D
PROCESS D
Output C
A P
A
C
C D
C
PROCESS B
U
Input B
Output B
S
Output F
A P
Internal
Internal
T
PROCESS
F
C D
Customer
Customer
O
A P
Input
F
M
C D
E
R New process: 從PDCA的P開始轉
Existing process: 從PDCA的C開始轉
Output D
E
X
T
E
R
N
A
L
C
U
S
T
O
M
E
R
P
D
Feedback
53
PROCESS CONTROL SYSTEM MODEL
WITH FEEDBACK
VOICE OF THE PROCESS
STATISTICAL
METHODS
MEN
CUSTOMERS
MACHINES
MATERIALS
METHODS
ENVIRONMENT

INPUTS
THE WAY WE WORK/
BLENDING OF
RESOURCES

PROCESS/SYSTEM
IDENTIFYING
CHANGING NEEDS AND
EXPECTATIONS

OUTPUTS
VOICE OF CUSTOMERS
54
Process Approach Model
Continual Improvement of the Quality
Management System
C
C
MANAGEMENT
RESPONSIBILITY
U
S
T
O
M
R
e
q
u
i
r
e
m
e
n
t
RESOURCE
MANAGEMENT
Input
E
R
PRODUCT
REALIZATION
Measurement,
Analysis,
improvement
PROCESS
Output
S
a
t
i
s
f
a
c
t
i
o
n
U
S
T
O
M
E
Product
R
55
5. TOP Management Processes
Examples:
4.1 Quality
Manageme
nt System
Processes
•Process to define quality policy and
objectives
•Communication process
•Management review
8. Measurement, Analysis
6. Resource Management
Processes
and Improvement Processes
Examples:
Examples:
•Determination and provision of
resources
•Processes to demonstrate:
(Fig 1)
•Conformity of product
•Human resources
•Conformity of
•Infrastructure definition
management system
•Work environment definition
•Continual improvement
7. Product Realization Processes
Examples: • Planning
•Customer related processes
•Design & development process
•Purchasing process
•Production & service provision
•Control of monitoring and measuring devices
56
Correct
NO
Improve?
OK?
YES
C
A
Identify Core Processes (COP’s)
Check Results
D
Customers
P
Process Design
Needs & Expectations
Product Design
57
• ISO 9001: 2000 8.2.3 Monitoring and measurement of
processes (流程之監督與量測)
The organization 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.
(組織必須使用適當之方法來監督和 , 必要時 , 量測QMS之
流程。這些方法必須能展示這些流程能達成既定/預期之結
果。當達不到既定/預期之結果時 , 組織 必須採取適當之改
正及矯正措施 , 以確保產品能符合規定)。
58
• ISO 9004: 2000 8.2.2 Measurement and
monitoring of processes (流程之量測與監督)
The organization should identify measurement
methods and should perform measurements to
evaluate process performance. The organization
should incorporate these measurements into processes
and use the measurements in process management.
(組織應該鑑別量測方法 , 而且應該執行量測 , 用以評
估流程之績效。組織應該將這些量測溶入流程之中 ,
並且使用這些量測來做流程管理)。
59
意即:「If you can’t measure it, you can’t manage it !
(如果你不能衡量它，就無法管理它!) 」。如果某一個
量度缺乏支持的資料 (i.e. missing measurements)，問
題可能是某一個主要策略目標的管理流程未臻完善
(robust) 或根本不存在。既然某一缺乏量測資料
(missing measurements) 之“關鍵績效量度指標”
(Key Measurable/KPI) 是組織之 senior management
共同決議產生的，則組織必須建立一個新流程來產生
這些KPI’s 所需要之data， 千萬不可陷入錯誤的迷思:
「We can’t measure what we want, so we have decided
to want what we can measure!」
另 , GE Jack Welch名言:「What you measure is what
you get — what you reward is what you get!」 60
Measurements should be used for managing
daily operations, for evaluation of the
processes that may be suitable for small-step or
ongoing continual improvements, as well as for
breakthrough projects, according to the vision
and strategic objectives of the organization.
(根據所訂之願景和策略目標 , 組織應該使用量
測來管理日常作業 , 來評估流程 , 不管該流程
是適合逐步漸進式的持續改善,或突破式的流
程/企業再造工程)。
61
Measurements of process performance should cover the needs and
expectations of interested parties in a balanced manner (e.g. BSC).
Examples include
以追求各個不同構面之間之平衡，流程績效之量測應該涵蓋相關利
益團體之需求和期望。可能之量測指標有:
-capability, (製程能力, e.g. Cpk)
-reaction time, (反應/回覆時間)
-cycle time or throughput e.g. 製造週期效能(manufacturing cycle
effectiveness, MCE)=
加工時間(Processing Time)
產出時間(Throughput Time)
-measurable aspects of dependability, (可靠度)
-yield, (良率)
-First-pass yields (第一次成功率)
62
-the effectiveness and efficiency of the
organization’s people, (人員之績效)
-utilization of technologies, (科技之使用率)
-waste reduction, and (減廢)
-cost allocation and reduction. (降低成本)
Determine Process Effectiveness
ISO 9000:2000 3.2.14 defines effectiveness as
“Extent to which planned activities are
realized and planned results achieved”
63
In determining process effectiveness, the assessor should
verify that the processes of the QMS result in:
-Results of (specific) process audit
-Internal Audit Results
-Financial measures (e.g.失敗成本failure costs.)
-Self-assessment (不同於internal audit)
-Achievement of the quality policy and objectives
(departmental/sectional goals)
-Achievement of planned arrangements
-Achievement of customer satisfaction (含
Internal Customer:下一工站之user: those
receiving the output of the process)
-Achievement of continual improvement
64
其實，從ISO 9001:1994開始，UL一直都是以
process approach在執行audit (例如APQP或
Quality Planning)
觀念: 品質看得見，「過程」是關鍵。
 linked/interacted/interrelated (交互作用/環環相
扣) 觀念:
The revised ISO 9001:2000 standard now follows a
process approach: 大體上分為Clause 7之Product
Realization Processes 「產品實現流程(e.g.直線作
戰單位/功能)」& Clauses 4, 5, 6 & 8 之
Associated Support Processes「相關之支援流程
(e.g.後勤支援單位/功能)」兩大類
65
過程(流程)管理:
過程管理意指完成某項任務，需要透過一連串活動的完成，才能
達到目的。
過去習慣上我們會只問結果，不管它是如何達成的，因此我們可能
投機取巧，留下甚多的後遺症。而日式的過程管理係著重為了要達
成任務有那些事情是必須要做的，日本人深信只要盡力去完成該做
的事，那麼結果自然不會太差。
而美式的過程管理則強調溝通，亦即將要完成的事情透過充分的溝
通，讓下一階段執行任務的人充分掌握，然後盡全力完成，最後所
追求的結果也會呈現，而過程管理強調將整個任務以各階段必要輸
出的完成，作為下一階段執行的輸入，一旦能確保各階段輸出與輸
入以系統化的完整處理，自可確保整個任務的有效達成。
COP:Customer Oriented/Focused Process/Procedure(替顧客加值
之流程):
程序/流程是手段，目的是為顧客創造價值，因此任何程序之設計要
66
「從顧客需要著手」，而非企業的需要。
A)「三部曲」/ISO 9001:1994, clause 4.2-(1). Intent/Adequacy of Procedures 「程序書之適合性/
“精神”或“意涵” 」?
(2). Implementation 「執行 or 落實」?
(3). Effectiveness 「效果」 ?
(ISO 9004 : 2000 QMS—Guidelines for performance
improvements更強調Efficiency “效率” 以達到
Interested Parties “利害關係者” 之滿意 : 含客戶,
員工, 股東/投資者, 供應商/夥伴, 社區團體…等.)
67
B) 「四部曲」/ISO 9001:2000, Clause 4.1—
1) A process/plan/method/approach?
2) Implemented?
3) Effective/achievement of planned/desired
results (outcome)?
4) Continual improvement?
指第一部曲之process 之持續改善, e.g. 「簡
化流程」, 因為
68
4.1 f The organization shall implement
actions necessary to achieve planned results
(第三部曲) and continual improvement of
these processes (第四部曲)。
觀念澄清: 關於第四部曲之CI是指 ISO
9001:2000 標準要求要做持續改善 , 但並非
是指每個各別之流程(process)都要做持續
改善。Assessor要看的是「能否看到當地的
(local)或中央的(centralized)所努力而獲之
CI 之證據」。
69
Effectiveness : Extent to which planned activities are realized
and planned results achieved (Focus of ISO 9001:2000)
Efficiency : Relationship between the result achieved and the
resources used (Focus of ISO 9004:2000)

Focus of TS-2: Effectiveness + Efficiency
* “說” ”寫” “做” 一致
(a). Do what you write.“做 (執行)”你所“寫”的(Common AR:
The procedure does not reflect the current practice in that….)
(b). Do what you say.“做 (執行)” 你所“說”的
(c). Write what you do/say.“寫下”你所“做/說”的
70
•Be
careful on (c) → ISO 9001:2000 只
剩九個強制性文件要求
Auditor 要有process mapping &
flowcharting概念。Company
procedure如果用flowcharting方式來寫，
更簡單易懂，people-friendly and
simple to audit! 如下例:
71
採購下單程序 (Procedure 12)
Procedure owner: 採購經理
Routine
requirements
generated from
system to
收到「採購需求」
(Form PR 001)
採購員
採購員
採購經理核准「採購需求」
(authorized signatory list: Form AS
001) 採購員
72
Request entered on system
(purchasing system software instruction
manual) 採購員
Suitable supplier located
(approved vendore list: Form 015)
(supplier appraisal procedure: Procedure
15) 採購員
Order reviewed
採購經理
73
Order correct
Suspect order discrepancy
Request returned to originator System processing completed
採購員
Purchase order produced (Form PO001)
採購員
74
Copy to
supplier
Copy to
accountants
採購員
採購員
Copy to file
Copy to
Incoming
Material
Receiver (接
到下一實例:
「How to
audit IQC?」
也是process
interaction
with IQC)
採購員
75
Input: BOM或轉至採購部之PR (Purchase Requisition 採購
需求)→一種「Stimulus」(刺激物)/ 「trigger」(扣板機)
Activities: 採購員check這些PR’s是否符合「核准/金額權限」
(list of authorized signatories: AS001)之人員核准，否則需
經過採購經理之核准；之後，採購員將PR’s鍵入電腦之
Purchasing System，並且開始由AVL (合格供應商名冊Form 015)之中去找適合之供應商，或者follow「新供應商
評估與選擇程序書-Procedure 15」去尋找一家新的供應商。
訂單(PO)開出經過採購經理審查之後，採購員就開始透過
Purchasing System 進行下單作業 (採購員已非常熟悉如何
操作這套採購系統，必要時也可check Purchasing System
Software Instruction Manual」)。
Output: 採購員將PO (訂單-Form PO001) 發出去給供應商，
copy各一份給會計及收料員 (Warehousing)，copy一份存檔。
76
如何effectively/efficiently用「三部曲」/ 「四部曲」
Approach結合Process Approach/Sequence/Interaction
(ISO 9001:2000 clauses 4.1b & 4.2.2c)/PDCA來執行新
版ISO 9001:2000之稽核？(Product Realization
Process/core process interacted with support processes
or other core processes之實例)
e.g. How to audit IQC 「進料檢驗」
Process/Activity/Function (clauses 7.4.3 & 8.2.4)？
比較有效的之稽核方式:
-先從第二部曲「Implementation」(D) 切入！(Note:
Highly-qualified auditor不會一開始就從第一部曲
「Adequacy of Procedure」, 埋頭苦讀公司之IQC77
Procedure/SOP/SIP, 或邊讀邊問…)
-Incoming Inspection is triggered by Material Receiver’s
Request→Input (everything begins with some kind of
「stimulus」刺激物) /Process Interaction
-從Critical Materials List (Input)上面sample足夠之
critical materials來稽核。
-請IQC Inspector開始demonstrate如何(Random)
Sampling (抽樣計劃)，如何用足夠capable (accuracy &
precision)之gage來執行檢驗by checking gage’s
precision/resolution 「精度/解析度」and calibration
record (bias/accuracy「準度」) against
Specs/Drawing/Acceptance Criteria established. (One-man
team或focusing on calibration/support process當地之local
activities)
-別忘了sample “worst-case” specification來測試該gage之
capability (clause 7.6)
78
-注意“calibration range” (校正範圍) 要能cover “usage
range” (使用範圍)
-或稽核 process/production path的auditor別忘了將sample
到的gage所量測之spec. (尤其是worst-case spec.) 及其他相
關資料 (e.g. gage number, location, 校正日，下次校正日
期…等) pass給另一組稽核儀校之auditor用以verify前述之
accuracy & precision。 (2-, or 3-man team)
-再看看Inspector如何填寫檢驗記錄 (如何修改inspection
data)? 檢驗不合格時如何處理 (clause 8.3)? 碰到
Reject/Critical NCP時有無follow clause 8.5.2 Corrective
Action by using e.g. Vendor CAR「悔過書」?
-檢驗合格 (output) 時如何link到Material Warehousing
(Process Interaction with Warehousing)?
79
-「檢驗結果」(output) 如何link到clause 7.4.1 Purchasing Process
當中之“Criteria for selection, evaluation and 「re-evaluation」
shall be established ” (e.g. Vendor Rating) 。 (也是Process
Interaction with Purchasing)。
-如果該Inspector對上述所有activities (throughput) 都做的很好
→clause 6.2.2 Competence, Awareness and Training & 第三部曲
「Effectiveness」。
-最後，Auditor才花2~3分鐘「速讀」(C)一遍IQC
procedure/plan/method to see if practices observed (D) match
procedure descriptions or plan/method established (P) (「第一部
曲」)，並且稽核clause 8.2.3 (Monitoring & measurement of
processes)。
同時看看有無Continual Improvement之証據 (「第四部曲」): e.g.
any changes to documents, designs or the way business is
conducted? 或「針對第一部曲之 process , 是否可以簡化該
80
process (工作/作業流程)」(A) ?
-當然，如果時間允許，Auditors應順便audit一些
company-wide clauses e.g. clauses 4.2.2 (Quality
Manual), 4.2.3 (Control of Documents), 4.2.4
(Control of Records)， 5.1 (Mgmt Commitment當中
之a. Communicating to the org. the importance of
meeting customer reqmts), 5.3 (Quality Policy ),
5.4.1 (Quality Objectives), 5.5.1 (Responsibility and
Authority), 5.5.3 (Internal Communication), 6.3
(Infrastructure), 6.4 (Work Environment), 7.5.3
(Identification and Traceability), 8.2.2 (Internal
Audit), 8.2.3 (Monitoring and Measurement of
Processes), 8.4 (Analysis of Data), 8.5.1 (Continual
Improvement), 8.5.3 (Preventive Action)….。
81
-必要時 ,也可以召集採購人員，IQC人
員，QA人員， 物管人員…等相關人員
來執行「跨功能稽核」, 達到「一次稽
核就能同時涵蓋 Purchasing 和 IQC 兩
個 Processes」, 對於稽核Process
Interaction而言 , 此方式之效果可能更
好!
82
UL是如何用「三部曲」/「四部曲」 及
Process Approach來稽核 Corrective
Action System? (Associated Supporting
Process之實例)
笑話一則: UL日本主管曾經interviewed過
一位某家Registrar之Assessor，詢問他如
何稽核Corrective Action，這位老兄回答
他們只看 CAR最下方之「效果確認」欄
位有人簽名(代表結案) 就可以了。當然，
這位老兄最後是沒有被錄取。
83
-「Show me CAR Tracking Log & 前半年/一年之
CAR’s」
-開CAR之時機 (e.g. critical NCP’s, 客戶報怨，IQC
reject trigger vendor CAR/不能只做退貨處理…)?
(Input/Process Interaction with 8.3 Control of NCP)
-Sample幾個代表性之CAR’s，開始稽核root-cause
identification，臨時對策，corrective action(s)
recommended (不可以只做「加強檢驗」)，有效結案…。
(throughput)
-If 「有效結案/Action taken was tested to be effective」
leads to 標準化→output/Process Interaction.
84
trigger
-- Pattern/trend of CAR’s
Preventive Action/ Mgm’t by
(Quality) Objective /C.I. Target…。 (output/process interaction
with 8.4 Analysis of Data/8.5.3 PA/5.4.1 Quality Objectives/8.5.1
C.I.)
-- 如果以上都做的很好(throughput)，代表「第二部曲」和「第三
部曲」沒問題，最後才花2~3分鍾做「第一部曲」&「第四部
曲」 ….。
Remarks: 在Business Processes當中，process interactions are
normally occurred via the usage of forms，會議/會簽…等. e.g. 連
絡單，流程卡，CFT meeting minutes…)→例如「客訴連絡單/處
理單 triggers CAR」， 「CAR triggers ECN」，「CAR triggers
FMEA review & update」，「CAR triggers increasing internal
audit frequency」，及「Pattern of CAR’s triggers PA」…。
85
ISO 9001: 2000
4.1 General requirements
The organization shall
a) identify the processes needed for the quality
management system and their application throughout
the organization ,
b) determine the sequence and interaction of these
processes,
…….
4.2.2 Quality manual
…….
c) A description of the interaction between the processes of
86
the quality management system.
ISO 9001:2000 Agenda (稽核行程) 之排法:
- 要用 “Process-based” 之排法 , 而不要用 “Clause-based” 之
排 法。
- Ensure the availability of top management:
Must UL request that all members of Top Management be
available for the audit?
It is highly recommended but not required that all members of
Top Management be available for the audit. The new standard
has placed considerable emphasis on the role of Top
Management, and it is in the client’s best interest to have as
many members of Top Management present during the audit as
possible.
87
-Auditor需在兩週前取得 Quality Manual，由其中之「a
description of the interaction between the processes of the QMS 」
，配合工廠之部門/功能/職掌說明 (via phone call)來排一個 userfriendly之agenda.
FAQ: 組織之一階品質手冊內並沒有描述「the interaction between
the processes of the QMS」，但是在個別之二階程序書(或三階作
業指導書)上面卻有描述 process interactions，可以嗎?
Ans: No! (see 4.2.2 c & 4.1 NOTE 之 4 大processes)，除非一階&
二階文件兩者合而為一。
注意: 一個沒有事先充分準備去瞭解「 org.之business是什麼?
Processes/process sequence & interaction是什麼? 」的新版之audit
是很容易被 「唬」過的!
請看下列實例:
88
品質手冊之「 Process sequence/interaction之描述」之實例:
附件一：
品質系? 流程圖
總經理室
管理課
管理
責任1
資源管
理11—1
生技課
業務部
資材
生產
客户
先期產品
品質規劃 2- 1
訂單
接收 3-1
物 料
申購4- 1
設備維護
6- 2
工程
品管
OK 來料檢驗5- 1
製 造
6- 1
擬訂生產
計劃 3-3
訂單審
查 3- 2
NG
經理? 以上人
員裁? 10-1
全檢/ 特採
客户供
應品4- 2
作業變更2- 2
NG
退回廠商
9—1
OK
反箱/重工
NG
特採
過程檢驗 5- 2
OK
成品檢驗 5- 3
NG
客户满意
14—4
反箱/ 重工
经理级以上人
員裁决10- 2
特采
OK
出貨 9- 2
NG
出貨檢驗 5- 4
儀器校驗7—1
產品標識與追溯及檢驗
與測試狀態 8—1
客户抱怨
處理14—2
客户抱怨
接收14—1
統計 15- 1
文件與資料管制及記錄
内部稽核
13—1
持續改善
14—3
12—1
89
過程、程序ISO/QS/TL關聯圖
? 子有限公司
附件二
系統過程
ISO9001
2000年條文
文件编号 責任單位
系統過程名稱
管理審查過程
流程名稱
管理審查
流程编號
1
先期產品品質規劃 2—1
設計與研發過程
XXP0101 總經理室
XXP0401
XXP0402
XXS0401
工程
作業變更
2—2
訂單接收
訂單審查
擬定生產計劃
物料申購
客户供應品
進料檢驗
過程檢驗
成品檢驗
出貨檢驗
3—1
3—2
3—3
4—1
4—2
5—1
5—2
5—3
5—4
XXP0301
XXP0301
XXP0301
XXP0601
XXP0701
製造
6—1
XXP0901 製造
設備維護
6—2
XXP0902
XXP0903 生技
檢驗量測與測試校驗過程 儀器校驗
7—1
XXP1101 品管
合约審查過程
原物料採購過程
檢驗過程
生產製造過程
頁次：1 OF 2
產品標識與追溯性及檢 產品標識與追溯及
8—1
驗測試狀態過程
檢驗與測試狀態
4.1+4.2.1+4.2.2+5.1+
5.2+5.3+5.4+5.5+ 5.6
7.1+7.2.1+7.3.1+
7.3.2+7.3.3+7.3.4+
7.3.5+7.3.6+7.3.7
7.2.1+7.2.2+7.2.3
業務
資材/工程
資材
7.4.1+7.4.2+7.5.4
資材
資材/客户
7.4.3+8.2.3+8.2.4
XXP1001
品管
XXS1001
XXP0801 生產
XXP1201 品管
文件? 號：XXQ0001
QS 條文及
TL條文
ISO9001 94版條文
4.1.1+4.1.2+4.1.3+
4.1.4+4.1.5
4.2.3.1+4.2.3.2+
4.2.3.3+4.2.3.4+
4.2.3.5+4.2.3.6+
4.2.3.7+4.2.4+
4.2.4.3+4..4+4.5.2.1
541C1+542C1+553C1+
衡量指標
71C1+71C2+71C4+731C1
+731C3+732C1+732H1+
732C2+732C1+737C1+
737C2+737H1+737HS1+
752HV1+ 753H2 +542C3
4.3.1+4.3.2+4.3.3+
4.3.4+Sec. II
4.2.4.2+4.6.1+4.6.2 741C1
+4.6.3+ 4.7
4.10.1+4.10.2+
4.10.3+4.10.4+
4.10.5+4.10.6+
4.10.7
755HS1+823C1+824HV1
+824HV2+824H1+824H2
+824H3
7.5.1a+7.5.1b+7.5.1c 4.9
+7.5.1d+7.5.1e+7.5.2 4.2.6
71C3+755C1
7.6
4.11
76H1
7.5.3
4.8
71HS1+753H1+731C2
4.12
90
頁次：2 OF 2
過程、程序ISO/QS/TL關聯圖
? 子有限公司
附件二
系统過程
流程名稱
系统過程名稱
流程编號
ISO9001
2000年條文
文件编號 責任單位
7.5.5+7.5.1f
退回廠商
9—1
出貨
9—2
經理级以上
人員裁决
10—1
10—2
產品搬運，包装，貯存
交貨過程
不合格品管制過程
資源管理過程
資源管理
文件? 號：XXQ0001
QS 條文及
ISO9001 94版條文
4.15
755H1
XXP1501 資材
XXP1502
XXP1503
XXP1504
XXP1505 資材
XXP1506
8.3
XXP1301 品管
4.13.1+4.13.2+
4.13.3+4.13.4
6.1+6.2.1+6.2.2+6.3+ 4.18
6.4
11—1
XXP1801 管理課
4.2.3+4.2.4
文件資料管制及記錄過
程
文件與資料管制及
12—1
記錄
内部稽核過程
内部稽核
13—1
客户抱怨接收
14—1
業務
客户抱怨處理
14—2
XXP1401
品管
XXP1402
矯正預防/持續改善過程 持續改善過程
14—3
統計
XXP1701 所有部門 8.1+8.2.2
8.5.1+8.5.2+8.5.3
4.17
4.14.1+4.14.1.1+
4.14.2+4.14.2.1+
4.14.2.2+4.14.3
723C2+723C3+723C4+
84C1+851C1+851C2
4.2.5+4.13.2.1
所有部門
4.1.6+4.19
52C1+52C2+542C2+
751C1+751C2+751HS1+
751HS2+ 821C1
4. 20
84H1
14—4
15—1
622C1+622C2+622C3+
622C4+622C5+622C6+
622HV1+ 64C1
4.5.1+4.5.2+4.5.3+ 423C1
4.16
XXP1901 業務
統計技術過程
723C1+723H1+824H4
XXP0501 所有部門
8.2.1
客户導向
TL條文
8.4
XXP2001 品管/ 資材
91
Process-based agenda實例:
Tentative Agenda
Date
Time
9/24/01 09:00
09:20
09:40
Path 1
Path 2
Opening Meeting 稽核前會議
Plant Tour 工廠巡視
設計與研發過程
Lunch
12:00
13:00
17:30
Path 3
--Continue--
原物料採購過程
生產製造過程
午餐
產品搬運，包装，
貯存 , 交貨過程
--Continue--
Daily Briefing 當日報告
92
09/25/01 09:00
合約審查過程
Lunch
12:00
13:00
檢驗過程
不合格品管制過程
午餐
--Continue--
生產製造過程
( Night Shift)
19:4021:00
13:00
17:30
--Continue--
Daily Briefing 當日報告
17:30
09/26/01 09:00
--Continue--
矯正預防/持續改善 檢驗量測與測試校
過程
驗過程
内部稽核過程
--Continue--
資源管理過程
文件資料管制及記
錄過程
產品標示與追溯性
及檢驗測試狀態過
程
統計技術過程
Daily Briefing 當日報告
93
09/26/01 09:00 --Continue--
--Continue--
--Continue--
午餐
12:00
Lunch
13:00
Report Writing 寫報告
15:00
Closing Meeting 結束會議
10/02/01 09:00 合约審查過程
(Off-site in Taipei)
13:00 --Continue--
17:30
Daily Briefing 當日報告
94
 「可稽核性」(Auditability) of ISO 9001:2000
– 大多數條文是prescriptive/traceable/ verifiable/specific
requirements, e.g. clause 8.2.2 Internal audit (內部稽核)
requirements包含了:
1. A documented procedure.
2. Auditing at planned intervals.
3. Audit planning based on status and importance.
4. Reporting of results.
5. Maintaining of records.
6. Taking Action on detected nonconformities & their causes.
7. Verifying of actions.
8. Reporting of verification results.
95
–多數這些prescriptive clauses/requirements ( i.e. hard
clauses/requirements)之Auditability是非常清楚，不易受到
質疑。可採用之稽核技巧，如多用open-ended interview
questioning technique: 「Show me the document, record,
procedure, plan, schedule, material or activity.」 , 配合前述
之「三部曲」/ 「四部曲」/Process Approach / PDCA…技
巧。
–但是少數一些Nonprescriptive or less prescriptive (soft
clauses/ requirements) 的Auditability就受到一些 「圈內人」
之質疑: e.g. 6.3 Infrastructure, 6.4 Work Environment & 7.5.5
Preservation of product: The organization shall preserve the
conformity of product during internal processing and delivery
to the intended destination。…因為這些條文並沒有要求要
有procedure, schedule, inspection, plan, method or record…等。
96
– 這些Nonprescriptive條文是如此地general，以致於有可
能Auditor會碰到「刁民」Auditee說 (或反問auditor):
「我們公司目前都已符合規定了，請你告訴我，我們那
個地方有違反規定！」這就好比要Auditor 「在乾草堆
中去找一根針」一般 (looking for a needle in a haystack)。
– 但是，有技巧之Auditor應反問Auditee: 「Show me why
there is no needle in the haystack!」by進行前述之「四
部曲」 /Process Approach / PDCA之稽核方式。例如，
Auditor可問下列open-ended questions:
1. Is there a plan or method (or process) for conforming to
the requirements? What is it? Has it been established?
(是否有建立一個plan或method或process來符合規定？)
97
–Has it been implemented (deployed)? (是否已
執行/已展開該plan, method/process?)
–Have planned results (outcomes) been
achieved? (是否達到預期/計劃之結果？)
–Is there improvement? Has the system/
process been changed? (是否做到持續改善？
System/process有變更嗎？)
*上述「四部曲」/ Process Approach / PDCA
是比較「積極」之稽核技巧 (亦可採用下述
之「負面表列法」), Auditor應善加利用!
98
*開 AR一定要清楚寫明發現之事證/樣本:
常用句子有 e.g.:
「No assurance (process/system in place)
that …..as evidenced by (寫上事證/樣本)」
「There was no objective evidence to indicate
that ….(寫上事證) 」。
「The procedure does not reflect the current
practice in that….(寫上事實) 」
99
*負面表列法之 AR , 事實俱在 , 非常具體 , 開這種AR通
常auditee 無話可說 e.g.
 Those famous last words like “as appropriate”, “as
applicable”, “where appropriate”, “as practicable”, and
“…appropriate…” indicated in ISO 9001:2000
requirements, 如Clauses 7.3.6/7.3.7/7.4.2/ 7.5.1…等.
 工廠常用self-developed sampling plan without
statistical validity, 而不用 MIL-STD-105E (AQL), 但是
assessors 不能開 “The sampling plan used by ….is not
statistically valid” (雖然你明知其抽樣計劃是很顯然沒有
統計基礎的)
100
6.3 Infrastructure
The organization shall determine, provide and
maintain the infrastructure needed 「to
achieve conformity to product
requirements」. Infrastructure includes, as
applicable
a) Buildings, workspace and associated
utilities,
b) Process equipment (both hardware and
software), and
c) Supporting services (such as transport or
101
Assessor只能開adversely affect conformity to
product requirements/unable to achieve conformity
to product requirements且沒有採行Corrective
Action Plan之事實/事証之AR。完全是company
management之責任，要去identify the root cause of
the AR看看是不是lack of infrastructure…。諸如
「xx設施不足」「沒有提供/維護xxx設備」之AR不
能開，這些是consultant之工作。
Where to assess: 1. APQP (Planning of Product Realization)
2. Management Review
3. Business Planning
4. Internal Audit
5. Customer Complaint
Handling / Customer
Satisfaction…..等
102
 6.4 Work
Environment: The
organization shall determine and manage
the work environment needed 「to
achieve conformity to product
requirements」.
•
Assessors 覺得工廠又髒又亂, 但能據此
開AR說工廠很髒亂嗎 ? (不一定吧!除非
assessor發現「adversely affect
conformity to product requirements」且
沒有採行CA Plan之事實！)
103
• ISO 9004:2000 6.4 Work Environment (含「身體方面」
及「人性方面」, 隱含「員工滿意度」之intent)
Management should ensure that the work environment
has a positive influence on motivation , satisfaction and
performance of people in order to enhance the
performance of the organization. Creation of a suitable
work environment, as a combination of human and
physical factors, should include consideration of
-creative work methods and opportunities for greater
involvement to realize the potential of people in the
organization.
-safety rules and guidance, including the use of
protective equipment,
-ergonomics (人體工學),
104
-workplace location,
-social interaction,
-facilities for people in the organization,
-heat, humidity, light, airflow, and
-hygiene, cleanliness, noise, vibration and pollution.
 6.4 Work Environment: ISO 9001:2000稽核需要考慮到
工安衛(Health & Safety)嗎？
答:Health and safety regulations should be considered to
the extent that they impact the conformity and quality of
an organization’s product/service.
e.g. For a sausage maker, does cutting finger affect
“product” quality ? 此情況可能不只是OHS之問題，也可
能是ISO 9001之問題，對不對 ?
105
負面表列法 之觀念是: 除非assessors 很
明顯發現上述情況已造成adversely
affect quality and/or delivery, or
customers are dissatisfied 「造成產品
品質不良，交期延誤，或客戶不滿意」
之事實，而且沒有採行 corrective
action plan, 才能開AR! 而且AR之寫法
是寫明“發現之事實/事證”。
(注意: 但是如果工廠有採取或正在執行
CI/CA/PA等，則不構成AR !)
106
Process approach

從流程著手稽核而非條文，重點在於每個流程
的有效性，再判斷單一條文的符合性。
順著流程稽核，不要被條文或文件主導。
PDCA(plan, do, check & act)的循環
例1：品質目標或改善方案(P)→執行流
程及現況(D) →時程追蹤及成效確認(C)→
未達成目標的矯正、標準化或進一步改善
(A) 。
例2：檢驗規範的要求(P) ←由FQC人員
的面談及以往的檢驗記錄(D及C) →不良
品的處理及矯正措施(A) 。
107
Automotive Value-Added Assessment vs. CSPMdriven Audit Planning
Best Practice #Auto 1: Effective Automotive Sector
Auditing - Using Customer Satisfaction
Performance Metrics to Guide On-site Audit Focus.
It was important that the OEMs see an improvement
in supplier performance - and that the supplier
performance metrics should be a first item on any
audit. If these were beneath expectations, they
should be used as a guide for auditing potentially
non-conforming systems. Auditors should look at
each OEM’s metrics relevant to a site (not just one
chosen for contract review) at every audit event.
108
“Output matters” - use Customer Satisfaction
Performance Metrics, CSPM, as an indicator of
QMS effectiveness and implementation;
 Request current CSPM before the audit, perhaps
in the audit plan;
Review the CSPM as the first item of the audit;
Include a notice to the client of the flexibility of
the auditor to change the audit track or timing
based on the results of the initial review of CSPM;
109
RAB supports a less rigid audit plan to handle
this variability;
Auditor should maintain an awareness of the
applicable CSPM requirements by each OEM;
Poor CSPM results should guide the auditor
towards evaluations of potential source
deficiencies in the QMS;
If auditor is not satisfied, system deficiencies can
become a documented basis for issuing nonconformance;
The CSPM and revised audit trail are
documented;
110
Insufficient
coverage of required surveillance
items - because of unplanned auditing resulting
from evaluating CSPM and related system nonconformities - is not acceptable; added effort
should be planned.
TS-2 Rule:
The organization shall provide the following
documentation to the CB for review, and for use in
planning the audit:
111
Quality manual (for each site to be audited)
Internal audit and management review planning and results from
previous twelve months
List of qualified internal auditors
List of customer specific requirements
 Customer complaints status
Operational performance trends for the previous 12 months,
minimum.
QS-9000 4.1.5 Analysis and Use of Company Level Data
The supplier shall document trends in quality, operational
performance (productivity, efficiency , effectiveness, cost of poor
quality) and current quality levels for key product and service
112
features.
These should be compared with those of competitors
and/or appropriate benchmarks.
Trends in data and information should be compared with
progress toward overall business objectives and lead to
action to support:
1) Development of priorities for prompt solutions to
customer-related problems,
2) Determination of key customer-related trends and
correlations to support status review, decision-making
and longer-term planning.
113
TS-2 8.4.1 Analysis and use of data
Trends in quality and operational performance shall be
compared with progress toward objectives and lead to
action to support the following:
 Development of priorities for prompt solutions to
customer-related problems;
 Determination of key customer-related trends and
correlation for status review, decision-making and longer
term planning;
 An information system for the timely reporting of
product information arising from usage.
NOTE Data should be compared with those of competitors
and/or appropriate benchmarks.
114
IATF Guidance to TS-2:
8.4.1 Analysis and use of data
Operational performance may include productivity, cost of
poor quality , process efficiency and effectiveness,
production output, quality performance, and equipment
utilization.
TS-2 Rule:
2.10 The audit plan shall include evaluation of all of the
organization’s QMS requirements for effective
implementation of ISO/TS 16949:2002 as well as for
effectiveness in practice. Assessment shall evaluate the
effectiveness of the system, its linkages, its performance
and its requirements.
115
Note: Effectiveness of the system should consider
how well the system is deployed, as demonstrated
by the measures defined by the organization to
meet customer satisfaction and company
objectives.
Initial certification audit activities shall be
conducted according to the following rules:
Review effectiveness of the implementation of
the ISO/TS 16949:2002 requirements and for
effectiveness in practice, related to planned and
achieved quality performance.
116
The Automotive Industry’s (IATF) Categorization of
QMS Processes are:
1. Customer Oriented Processes (COPs): 常見之10
COP’s
Market Analysis/Customer Requirements
Bid/Tender
Order/Request
Product and Process Design
Product and Process verification / validation
Product Production
Delivery
117
Payment
Warranty/Service
Post Sales/Customer Feedback
2) Support Processes:
常見之Support Processes:
Sales & Marketing, Customer Services,
Calibration/Maintenance, Purchasing, Human
Resources, IT (Info. Technology), Procedures,
Finance (i.e.生產要素: 人、機、料、方法、環境、量測…)
3) Management Processes (Mgmt decisions/actions):
Planning ( i.e. Business planning , Quality
planning/APQP , QMS planning…), Resource allocation,
budgeting, periodic reporting, management meeting
118
(management review)…。
TS-2
8.2.1.1 Customer satisfaction-Supplemental
Customer satisfaction with the organization shall
be monitored through continual evaluation of
performance of the realization processes.
Performance indicators shall be based on
objective data and include, but not be limited to:
Delivered part quality performance,
Customer disruptions including field returns,
119
Delivery schedule performance (including
incidents of premium freight), and
Customer notifications related to quality or
delivery issues.
The organization shall monitor the
performance of manufacturing processes to
demonstrate compliance with customer
requirements for product quality and
efficiency of the process.
120
QS-9000 APP. I:
Customer Performance Requirements
Effectiveness of a company’s system must be
measured by indicators which directly correlate and
meet customer performance requirements, such as
customer satisfaction (4.1.6), on-time delivery (4.14.6)
or continuous improvement (4.2.5), and tracked by
the use of these indicators. The presence of continued
poor trends in these indicators, audit to audit, will
jeopardize continued QS-9000 registration.
121
Customer Satisfaction
To satisfy the QS-9000 requirement for
determining customer satisfaction (4.1.6),
customers such as Chrysler, Ford, GM provide
suppliers with performance reports either on-line,
e.g. Chrysler’s “PASS” report and GM’s PRR
system, or monthly, e.g. GM’s “quad” report for
North American suppliers listing the relevant
performance data. Certification bodies/registrars
should ask suppliers for copies of such reports to
determine customer satisfaction during the
registration audit and during surveillance.
122
Misrepresentation of Information
Misrepresentation of customer complaint information
(for customers subscribing to QS-9000) by a supplier to
a certification body/registrar shall result in the
certification body/registrar immediately invoking their
delisting process for that supplier and immediately
notifying the customer(s) involved.
123
先從「PDCA循環」當中
之C & A Segments
“C”「檢討」和 “a”「改
善」
[“A”: Correction , CI, CA & PA ]
開始談!
124
8.2.2 Internal Audit (內部稽核)目的: 用以
量測/決定QMS effectiveness
•如何確認內部稽核是完整且深入(thorough
& comprehensive)?
－4.2.4 Records (e.g. audit schedule/agenda,
reports/detail notes，缺失報告…等)是否完
整?

(ISO 9001:2000 An audit program...the
results of previous audits)
－6.2.2 Auditors資格?
125
(ISO 9001:2000 Auditors shall not audit their own work。
較寛鬆)
－8.5.2/8.5.3/8.2.2 缺失報告＆有效結案?
(ISO 9001:2000增加…actions taken to eliminate detected
nonconformities and their causes）
－ 可用detail notes, 但也不表示只用「總結報告＋質量深
入之缺失報告」就不夠thorough.
－甚至可直接interview內部稽核員或observe其實際執行稽
核來確認Auditor competency(6.2.2)
-- 建立確保不同質之製程／流程（dissimilar process areas）
及所有條文(clauses) ，甚至所有班別都能被定期被稽核的
機制。
126
ISO/TS 16949: 2002
8.2.2.1 QMS audit
The organization shall audit its QMS to verify compliance with this
Technical Specification and any additional QMS requirements.
8.2.2.2 Manufacturing process audit
The organization shall audit each manufacturing process to
determine its effectiveness.
8.2.2.3 Product audit
The organization shall audit products at appropriate stages of
production and delivery to verify conformance to all specified
requirements, such as product dimensions, functionality, packaging,
labeling, at a defined frequency.
127
8.2.2.4 Internal audit plans
Internal audits shall cover all quality management
related processes, activities and shifts, and shall be
scheduled according to an annual plan. When
internal/external nonconformities or customer
complaints occur, the audit frequency shall be
appropriately increased.
NOTE Specific checklists should be used for each audit.
8.2.2.5 Internal auditor qualification
The organization shall have internal auditors who are
qualified to audit the requirements of this Technical
Specification
128

常見的內部稽核之Failure Modes
公司自己的內部稽核結果是零缺點，但外部稽核
(驗証單但或客戶) 卻發現許多缺點甚或嚴重缺失，
則可推論公司內部稽核無效。

由稽核記錄可以明顯看出內部稽核不夠
comprehensive，例如：公司規定以Check-lists
(稽核查檢表)作為主要記錄，但Check-lists上面
的項目都是一些通則性問題，而沒有實際稽核所
得的客觀証據如部門、人、sample size．．．等。

129
稽核計畫以不變應萬變，負責規劃的主導者
無法說明如何將被稽單位的重要性以及以往
的稽核成果納入考慮，例如因為客訴而增加
頻率。


其他容易造成內稽失效的原因如：
公司高層不夠重視
稽核員不懂被稽者之工作/業務流程，對
ISO 9000標準了解不夠
稽核技巧及後續之“Auditor
Qualification Maintenance”不夠
130
除了加強訓練Audit Skills之外，何妨考慮
a) 將內稽結果和個人/部門考績掛勾。
b) 將Auditors至少分為行政組和技術組兩
組，再由各組之組內互稽，同時由Lead
Auditor根據個人背景不同來排
Schedule，避免造成「外行稽核內行」
之情況 ; 或以「後製程人員稽核前製程」
(Internal Customer之觀念)
131
c) 儘量採用「精兵制」或委外給專業人
士來執行，而且要嚴格執行後續之
“Auditor Qualification Maintenance”
之規定(可參閱 ISO 10011-1,-2 & -3)。
試想絕大部分之公司都採用「多兵
制」，平均每年每人做不到1~2次稽核
，這種內稽會有成效才怪?！
d) 執行unannounced audit (i.e. ISO 9001
所規定之…..importance and status…)，
讓auditee沒機會「彩排」。
132
e) FAQ: Element 8.2.2. Internal Audit (內部稽核)，甚
或採用2nd-party (vendor) audit 來滿足 element
7.4.1 Purchasing process 或 TS-2 7.4.1.1 Supplier
QMS development 之 2nd-party audit 一定要由組織
(organization)內部之人員來執行而不能委外
(outsource)嗎?
答: 不一定，ISO 9001:2000 & TS-2並沒有規定說「內
稽」和「供應商稽核」不可以委外! 因為:
•
ISO 9000:2000 2.8.2 First-party audits are
conducted by, or “on behalf of”, the organization
itself for internal purposes and can form the basis
for an organization’s self-declaration of conformity
133
•ISO 9001:2000 4.1 “…where an organization
chooses to outsource…”
• QS-9000 4.6.2.1 …由3rd-party 來做
但是，要注意:
• TS-2 4.1.1 … & Guidance…:不可以delegate
technical leadership…
(註: 雖然ISO 9001:2000及 TS-2說任何process –甚
至包括7.3之Design & Development & 7.5 之
Production & Service provision均可以委外，但是
以QS-9000或TS-2而言，不可以將production全部
134
委外… )
(笑話一則: 某家registrar自己規定說內稽一定要用公司本身自
己人員來做。If so，請問世界紀錄取得ISO 9001:2000之
one-man company如何滿足內稽規定?)
Audit Checklist 之使用 :
 可能造成 「見樹不見林」，迷失方向 (i.e. 看不到Big
Picture) 之情況!
 並非萬靈丹 , 要小心使用!
 各種稽核用表單(或checklist)之設計應避免限制了auditor進
行必要的調查/稽核。
 Automotive Process Approach to auditing for ISO/TS
16949:2002 must not be driven by a “clause” or a “section”
driven checklist. Instead the checklist should be a tool to
verify the completeness of the audit, which means that the
auditor shall audit all applicable requirements to an
135
identified COP.
稽核時可考慮的課題(ISO 9004)

各種流程的effectiveness及efficiency
持續改善的機會
各種流(製)程(process)的能力
統計技術的使用成效
資訊科技(IT)的使用
品質成本分析
各項流程及產品績效(performance)的成果與
期望
各種績效的評量是否充分及正確
各種改善活動
與各種利害相關者(interested parties)之關係

136
以符合客戶要求的績效作為QMS有效
性的衡量指標(QS-9000) ，並在內部
稽核中追蹤這些指標的趨勢 --- 連續的
不良趨勢可能代表了品質管理系統的
失敗，常見的指標如：
客戶滿意度
準時交貨績效
持續改善成效

137
歷次稽核結果的分析(trending)

Remarks: 如果上述兩項都顯示
downward/unfavorable trends，公
司的Top Management要非常小心了!
鼓勵稽核員將重點放在所稽核的
對象(過程或流程)“是否有效” 及
“是否持續改善(該流程)”，而非
“是否符合”。

138
不符合事項

清楚地陳述事實的內容及違反的標準
確認受稽核單位的主管瞭解不符合事項
的內容
系統性的缺失或是獨立事件？


稽核的報告
內容包括完成的稽核計畫、觀察及不符
合事項、品質管理系統是否有效。也可
包括優異的表現，以鼓舞士氣、使管理
者注意。

139
－QS-9000 4.17.1 ：…cover all shifts (包含所有班
次: 含graveyard shift，因通常較多NCP)。 When
internal/external nonconformances or customer
complaints occur, the planned audit frequency
should be increased (當重大不良/客訴發生時，應
增加稽核頻率)（vs. ISO 9001:2000之…the status
and importance of the processes and areas to be
audited…)。注意: Mechanism (system) for
assuring this should be in place. e.g.在CAR上面多
一個欄位「Audit frequency increased?」; 或授權
以Internal audit planner/scheduler責任，在每次排
audit schedule/agenda時，必需review先前所開之
CAR’s決定是否要增加稽核頻率。
140
Process oriented auditing
IATF expects TS-2 auditors to audit Customer Owned
Processes (COP，也有人稱為Customer Oriented
Processes 或 Core Processes). The COP is a model that
was introduced by ISO 9001:2000 and refers to the fact
that any organization needs customer input to comply to
specified and expected needs of the customer (output). This
is accomplished by value adding processes of product
realization and appropriate support processes, both
enabled by management activities and provided resources.
The audit approach of TS-2 must not be driven by an
“element” or a “section” driven checklist. Instead the
checklist shall be a tool to identify the completeness of
the audit, which means that the auditor shall audit all
141
applicable requirements to an identified COP.
Automotive Value-Added Assessment vs. CSPMdriven Audit Planning
Best Practice #Auto 1: Effective Automotive Sector
Auditing - Using Customer Satisfaction
Performance Metrics to Guide On-site Audit Focus.
It was important that the OEMs see an improvement
in supplier performance - and that the supplier
performance metrics should be a first item on any
audit. If these were beneath expectations, they
should be used as a guide for auditing potentially
non-conforming systems. Auditors should look at
each OEM’s metrics relevant to a site (not just one
chosen for contract review) at every audit event.
142
“Output matters” - use Customer
Satisfaction Performance Metrics, CSPM, as
an indicator of QMS effectiveness and
implementation;
 Request current CSPM before the audit,
perhaps in the audit plan;
Review the CSPM as the first item of the
audit;
Include a notice to the client of the flexibility
of the auditor to change the audit track or
143
timing based on the results of the initial review
RAB
supports a less rigid audit plan
to handle this variability;
Auditor should maintain an
awareness of the applicable CSPM
requirements by each OEM;
 Poor CSPM results should guide the
auditor towards evaluations of
potential source deficiencies in the
QMS;
144
 If auditor is not satisfied, system
deficiencies can become a documented basis
for issuing non-conformance;
 The CSPM and revised audit trail are
documented;
 Insufficient coverage of required
surveillance items - because of unplanned
auditing resulting from evaluating CSPM and
related system non-conformities - is not
acceptable; added effort should be planned.
145
•MONITOR:
–“Observe, supervise, keep under
review, measure or test at intervals,
especially for the purpose of regulation
or control”
•MEASURE:
–“Ascertain or determine the spatial
magnitude or quantity of something, by
the application of some object of known
size or capacity or by comparison with
some fixed unit”
146
Glossary
Correction (C):
Action to eliminate a detected nonconformity
NOTE 1 A correction can be made in conjunction with a corrective
action
NOTE 2 A correction can be, for example, rework or regrade
Corrective Action (CA):
Action to eliminate the cause of a detected nonconformity or other
undesirable situation
NOTE 1 There can be more than one cause for a nonconformity.
147
NOTE 2 Corrective action is taken to prevent recurrence whereas
preventive action is taken to prevent occurrence.
NOTE 3 There is a distinction between correction and
corrective action.
Preventive Action (PA):
Action to eliminate the cause of a potential nonconformity or other
undesirable potential situation
NOTE 1 There can be more than one cause for a potential
nonconformity.
NOTE 2 Preventive action is taken to prevent occurrence whereas
corrective action is taken to prevent recurrence.
148
Continual Improvement (CI):
Recurring activity to increase the ability to fulfill requirements (ISO 9000)
NOTE The process of establishing objectives and finding
opportunities for improvement is a continual
process through the use of audit findings and
audit conclusions (8.2.2), analysis of data (8.4),
management reviews (5.6) or other means and
generally leads to corrective action (8.5.2) or
preventive action (8.5.3).
說明:「建立目標」和「尋找改善之機會」(CI)是一透過使用ISO 9001之3工具
(i. e. 管審 , 稽核和資料分析)或其他方式之持續不斷之流程 , 並且通常會導致於
CA和PA。因此 , 此概念也說明了新版ISO 9001之條文編排順序: MR IA
AOD
CI CA PA
想一想: ISO 9001 是一個大的 tool kit , 裡面有各種不同之tools (e.g. MR, IA,
AOD…等)
149
含“small-step, on-going improvement activities ( i.e.
continuous/incremental/local improvement on existing
processes)”「逐步漸進式的持續改善」和
“breakthrough projects (i.e. discontinuous improvement
it will usually reveal entirely new business processes at
which an organization must excel)”「突破式的流程/企業
再造工程, e.g. 6-sigma strategies, Re-engineering… 」
(QS-9000: CI requirement does not replace the need for
innovative improvement「(流程/技術/知識)創新」)
ISO/TS 16949: optimization of characteristics and
parameters of a product or process at a target value
NOTE Continual improvement is only applicable where
conformance has been established.
150
Customer Satisfaction (CS):
Customer’s perception of the degree to which the
customer’s requirements have been fulfilled
NOTE 1 Customer complaints are a common
indicator of low customer satisfaction but their
absence does not necessarily imply high customer
satisfaction.
NOTE 2 Even when customer requirements have
been agreed with the customer and fulfilled, this
does not necessarily ensure high customer
satisfaction.
151
Customer Delight (CD):
ISO 9004: Organizations depend on
their customers and therefore should
understand current and future customer
needs, should meet customer
requirements and strive to exceed
customer expectations (i.e. 「顧客喜悅」
customer delight.) 。
152
試由下列三條文來區分Correction和CA之差異:
8.2.3 Monitoring and measurement of processes: … when
planned results are not achieved,「correction」and
「corrective action 」shall be taken, as appropriate, to
ensure conformity of the product.
8.2.2 內部稽核
8.3 不良品管制
「Problem Resolution
CD」 Progression (演進):
153
條文
說明
Immediate/Interim/Remedial
C
8.3
Action(s) e.g. rework/repair,
(8.2.2
& 8.2.3)
regarde/downgrade,
containment, scrap/reject,
concession, G8D之D3
QS-9000 4.9.2
(Develop the Interim
& TS 16949
Containment Action) ,
8.2.3.1之
Reaction Plan 「治標」e.g. 打「退燒針」, 頭痛
in Control Plan
(只是syndrome): 吃「普拿
疼」, 但root-cause 可能
是腦瘤……
154
Root-Cause(s) elimination , 「治
CA
8.5.2,
(腦瘤)徹底根除!…
QS-9000
4.9.2 & TS
16949 8.2.3.1
之CA Plan
PA
本」 i.e. 對症下「對」葯，把病因
8.5.3
8.4
eliminating the cause(s) of a potential
nonconformity, 打預防針/疫苗
《 養生秘笈》午睡有防止心臟病的
發生作用，凡堅持每天有三十分鐘
午睡 習慣的人，他們的心臟病發生
率減少30 %。 Best approach:
均衡及充分之飲食 / 運動 / 睡眠/來
提高自身免疫系統
155
CI/
8.5.1
Is there a way that is Better (Q), Cheaper
(C) & Faster (D)?
Innovation
CS
Kaizen (Kai「改」means change and
Zen「善」means good): continual
improvement of all areas of a company,
not just quality.
8.2.1
不僅僅是「客戶抱怨處理」和
GS (Good Service):「好的服務」而已!!
156
ISO 9004,
CD
6-sigma
strategies,
Excellence
Models…
超越滿足顧客: 顧客喜悅!
P.O.S ( Positively Outrageous
Service):超出預期的「非常服務」
157
時常被問 (FAQ):「ISO 9001有規定所有的量測數據
actual values for measurements都需要寫在Inspection
Report上面嗎？例如，有時我們抽50個樣品量測厚度，
但只記錄前10個樣品之量測數據或只記錄“OK”或
“合格”，可以嗎？
→答案在8.2.4—Evidence of conformity with the
acceptance criteria shall be maintained. Records shall
indicate the person(s) authorizing release of product. 甚
至只記錄“OK”或“合格”亦可以，但需確定defined
acceptance criteria (所定義之允收標準) 清楚否？
Inspectors會不會執行required inspection (i.e. inspectors
之competence/qualification)?
158
Acceptance criteria之訂定原則: “Subjective terms are
not acceptable; objective criteria must be defined to
ensure consistent inspections.”(主觀性用詞不好，必須
訂定客觀性基準用以確保一致性之檢驗結果)。尤其
是碰到一些外觀檢驗 (visual inspections)，或QS9000所謂的外觀件 (Appearance Items) 之
Controls/Inspections，需做到「The
conformance/acceptance criteria must be clearly defined
and the procedure for deciding if these criteria are met
must produce consistent results over time)允收/符合基
準必須定義清楚，而且用來決定是否符合這些基準
之“程序”必須都能產出一致性之結果)」。
159
舉例如下:
Acceptance Spec.
Comment
•Surface should be free
from flaws.
•What is a flaw?
(表面不可以有瑕疵.)
•Surface should conform to
master standard in color,
texture, brightness and
imperfection.
-Do inspectors agree?
-How measured?
Conform to what degree?
•How measured?
(表面必須符合顏色/光澤
比對標準)
160
QS-9000 4.9.6 (Appearance Items外觀件) 要求工廠
必須提供:
• Appropriate lighting for evaluation areas (執行外觀
檢驗之區域要有適當的亮度)
•Masters for color, grain, gloss, metallic brillance,
texture, distinctness of image (DOI) as appropriate (適
當之外觀比對標準)
•Maintenance and control of appearance masters and
evaluation equipment—See ISO 9001:1994 4.11.2b
(比對標準/設備之維護及管制)
•Verification that personnel making appearance
evaluations are qualified to do so (執行外觀比對人員
161
之資格証明)
-另外，出現在條文8.2.4 這個字 “the acceptance
criteria”也表示「values with tolerances or
minimum/maximum values must be specified (公差
或最大/最小值必須訂清楚)」
(Common AR: 檢驗用之尺寸圖面沒有訂公差 ,
Max.值或 Min.值).
-Assessor對於前述之「檢驗報告沒有記上實測值，
只show “checked OK”」之情況，最好
「investigate further by witnessing tests to validate
records (親自抽樣請工廠之inspector表演他是如何
進行檢驗，用以驗證他填上“checked OK”之有效
性)」。
162
-當然，記錄實測值之目的大部分是為了執行「製程/產品
能力分析&改善」，即所謂的Variable Data (計量值)觀念
(vs. 前述之“checked OK”/“GO-NO GO”—Attribute
Data計數值觀念).
-如何稽核「consistent inspections (一致性之檢驗結果)」?
方法之一: kind of “隔離訊問/interview” 不同人(2人以上)
從事同樣之外觀檢驗。
重點說明:「Interview Techniques 」vs. 「“Qualitative”
Objective Evidence/ “ Quantitative” Objective Evidence 」
vs. 「Training/Competency can replace Work/Job
Instructions, but Training/Competency can not replace
Specifications」
163
Scenario: 「如何有效維持一個只有 3-4人規模之加
油站之 ISO 9001:2000-based QMS?」
--「減紙化QMS」, 甚至「無紙化QMS」(paperless
QMS) ! How?
(此處之papers包含「文件」和「記錄」)
-- 可能方法有: 「Training/Competency can replace
work instructions→減少文件」, 儘量提供“定性的”
客觀證據 , e.g. ISO 9001:2000 新版的一些
communications 之規定→減少記錄」「電腦化作業
→減少文件&記錄」
164
-- 甚至全公司之 QMS Documentation 只有一本
10~20 頁左右之品質手冊 , 其內容大部分只是將ISO
9001: 2000標準之規定重新用不同之語法重寫 , 但意思
一樣(為避開copy right) , 加上一些「process
sequence/interaction之描述」和常用之作業表單 , 可
以嗎?
-- World record: 有一家one-man company取得ISO
9001証書, 如何做ISO 9001:2000 5.5.3 Internal
communication 呢？ (想一想: 太多的 documented
procedures是否可能會阻礙communication?!)
165
--- 然而 , ISO 9001:1994 之 4.1~
4.20 之 20個 條文都要求要 建立
documented procedure , 加上
audit evidences 都似乎 focus 在
“ Quantitative(定量的)”
Objective Evidences , 試想像這種
3~4人之小公司如何 maintain ISO
9001/2: 1994-based QMS 呢 ?
166
QS-9000 4.10.1.1
Acceptance Criteria for 「Attribute
Characteristics」--Acceptance criteria for
attribute data sampling plans shall be
「zero defects」. Appropriate acceptance
criteria for all other situations (e.g. visual
standards) shall be documented by the
supplier and approved by the customer.
167
---此 “Zero Defect” (零缺點/0收1退) 是一種 “Cost Down” 之
檢驗方式 , 其合理之呈現過程應如「Tightened Inspection
Normal Inspection
Reduced Inspection
“Zero Defect”
“Dock-to-Stock/Ship-to-Stock practice”(免檢)」
---為降低風險考量，通常適用於 highly stable & capable 之
processes/products 或一些 visual inspections.
---指 attribute characteristics(計數值特性之抽樣計劃), 如
「Go/No-Go, Yes/No」之data ，並非指 attribute sampling
plan, 如 Mil-STD-105E表。
--- 可用「Zero Acceptance Number Sampling Plans ( 0收1退抽
樣計劃表)」, 或「降低AQL至0收1 退之抽樣計劃 (e.g. 使用
Mil-STD-105E 時)」 , 或「refine/redefine /加嚴 conformance
criteria用以將原先非0收1退之抽樣計劃變成0收1退之抽樣計
劃」…。
168
但是碰到檢驗不合格時，就需要記錄
詳細之實測值，why? 答: 8.3 不良品
管制—Records of the nature of
nonconformities and any subsequent
actions taken, including concessions
obtained, shall be maintained (“不良
品”/“不良狀況”之性質以及任何後
續採取之行動/對策，包括特採等，均
需保留記錄)，其目的為:
169
1) 8.4 Analysis of Data (資料分析)
2) 8.5.1 Continual Improvement (持續改善)
3) 8.5.2 Corrective Action (矯正措施)
4) 8.5.3 Preventive Action (預防措施)
5) QS-9000 4.13.2.1 Prioritized Reduction Plan: The
supplier shall quantify and analyze nonconforming
product and establish a prioritized reduction plan.
Progress toward the plan should be tracked: 供應商需
量化和分析不良品，並且要建立一個優先降低 (不良)
計劃。對於此計劃之進展狀況應該要追蹤。
:
:
等
170
另有人問 (FAQ):「是不是大大小小之不良都要記錄？」
Ans: 最好要 (value/contribution consideration) ，雖然
不見得每一個大大小小之 nonconformity都要開 CAR。
ISO 9004:2000有一句話「The org. can also consider
recording information on those nonconformities that are
corrected in the normal course of work. Such data can
provide 「valuable」 information for improving the
effectiveness and efficiency of processes 」，再看看8.3
「 不良品管制」，8.5.2 Corrective Action , 8.5.3
Preventive Action…怎麼說。
e.g. Pareto Analysis (柏拉圖分析):「to separate the vital
(critical) few causes from trivial many」meaning 「to
look for the 20/80 rule of thumb(經驗法則)…20% of the
171
causes producing 80% of a problem」
過程如下:
Check Sheet (用次數分配表/查檢表來收集前述「大大小小之不良」
及 causes之historical data)
Pareto Analysis of Effects/ “Effect” Pareto Chart:( 圖1)
Cause-and-Effect Diagram/ “魚骨圖”或“要因分析圖”: ( 圖
2)
Pareto Analysis of Causes/ “Cause” Pareto Chart: ( 圖3)
CA/PA determined and taken
172
“Effect” Pareto diagrams may be
used to compare results before and
after a change (CA) was made (taken)
to show progress :( 圖4)
Case closed if showing progress
(evidence of verifying CA effectiveness)
173
UNITS, HOURS OR DOLLARS
100
(圖1)
80
Pareto
Analysis of
Effects
60
40
20
0
A
B
C
D
EFFECTS CATEGORIES
METHODS
E
MANPOWER
(圖2)
POSSIBLE CAUSES
OF EFFECT “A”
EFFECT “A”
MATERIALS
MACHINES
Cause-andEffect
Diagram
174
UNITS, HOURS OR DOLLARS
600
100
500
85
400
69
300
46
200
圖3
Pareto Analysis
of Causes
100
0
CAUSES CATEGORIES
「 the 20/80 rule of thumb(經驗法則)…20% of the causes
producing 80% of a problem」
175
圖4
Before-and-After Measurement
UNITS, HOURS OR
DOLLARS
UNITS, HOURS OR
DOLLARS
60
60
DIFFERENCE
BETWEEN TWO TIME
PERIODS
40
40
20
20
0
0
EFFECTS CATEGORIES
BEFORE CHANGE
EFFECTS CATEGORIES
BEFORE CHANGE
176
8.5.2
Corrective Action (矯正措施)—再發防止。
CA’s shall be appropriate to the effects of the nonconformities
encountered.
--視問題大少/嚴重不一程度(risk level)？成本能降多少 (改善成本
與回收效益之比較)？如不改善，風險有哪些 (無形的也要評估)？
再施以適當之CA , i.e. 尋求最佳之解決方案 among all possible
solutions by透過「影響力/執行力矩陣」(X軸是影響力
, 亦即方案執行後的影響程度 , Y軸是執行力 , 亦即方案推行的難
易程度) , 篩選出最佳的解決方案。如果方案落在「影響力最大
, 推行度最容易」的象限 , 那就應該當機立斷 ，馬上針對此方案
定行動計劃。總不能說花100萬之CA，只有10萬之「投資報酬
率」。
177
--(新)….to define requirements for
--a) reviewing nonconformities including customer
complaints:
說明 1: 要先決定需要review那些sources of
information (e.g. 客訴報告，內稽報告，不合格品
報告….等)，再找出那些cases需要採取CA , 亦即
「決定需要採行CA之時機」，並予以prioritize(排
序)。
說明 2: 訂定「時機」原則有三
1. 標準化(法治): 缺點為「僵化」, 「無彈性」
2. 靠“人”做決定(人治): 缺點為「濫權」, 「誤
判」
178
請思考一下下列二則新聞報導:
1) PCB廠健鼎董事長王景春認為，由於韓國廠商技術面較台灣廠
商強勢，「而國內廠商對SOP(標準作業程序)規定常不按部就
班，直接影響產品良率」，因此，廠商對於產品品質的控管仍
須強化，以便在歐美廠商釋單的過程中取得先機(製造業)。
2) 紐約國際顧問公司GM陳文敏說:「建立SOP有助於員工遵守
流程，但也要給予應變的空間與彈性。」她說了一則故事:我
的朋友在上星期六(21號) 打到國內一家航空公司去訂北高機位。
一位訂位小姐問她:「請問你要訂哪一天?」朋友: 「下個星期
一」訂位 : 「請問你是要訂幾號?」朋友: 「就下星期一，我不
知道是幾號」訂位 : 「你不知道幾號，我就不能幫你訂。」朋
友: 「那你知道今天是幾號嗎?」訂位 : 「知道啊，是21號」朋
友:「如果你知道今天是21號，那下星期一不就是23號嗎?為什
麼不能訂?」這段無厘頭的對話下來，你可以想見結局是:我朋
友憤而掛斷電話改訂其他家去了。為什麼訂位小姐會失去這位
顧客？原因不在於她的態度不禮貌，而在於她太過於嚴守
179
SOP(標準作業流程)，毫無彈性可言。
所以企業要問自己的是:
服務的邏輯是什麼?公司應要求大家緊抱SOP不放，謹守
分寸?還是將SOP「僅供參考」?還是根本不需要什麼
SOP?
若企業想將服務落實，建立SOP 是絕對必要的，更需要所
有同仁都確實遵守。但是重點有二:
1. SOP是否「量身訂做」? 確實可行?簡單、明瞭而易行?
2. 在遵守SOP與臨場應變中間，企業容許員工有多少空
間?
在美國有項服務調查顯示:最容易讓顧客火大的一句話是:
「對不起，這是公司規定」，若是口氣冰冷，面無表
情，那麼這句話便如尖利的劍劃過顧客的喉，如火辣
180
辣的巴掌打到顧客臉上(服務業)。
e.g. 1) ISO/TS 16949之8.2.3.1及8.5.2.4硬性規定CA之時機: 
當「管制計劃」(control plan)上面所列的產品 (製程) 特性 (參
數) 出現unstable或 non-capable 時，必須先執行reaction plan
(反應計劃: containment或100% inspection) , 之後再執行CA
plan (矯正措施計劃); 當客戶退貨時，必須執行 Root-Cause
Analysis 和 CA process!
ISO/TS 16949 8.2.3.1:
The organization shall initiate a reaction plan from the control
plan for characteristics that are either unstable or non-capable.
These reaction plans shall include containment of product and
100% inspection as appropriate. A 「 corrective action plan」
shall then be completed by the organization, indicating specific
timing and assigned responsibilities to assure that the process
becomes stable and capable. The plans shall be reviewed with
and approved by the customer when so required.
181
ISO/TS 16949 8.5.2.4 Rejected product test/analysis
The organization shall analyse parts rejected by the
customer’s manufacturing plants, engineering facilities
and dealerships. The organization shall minimize the cycle
time of this process. Records of these analyses shall be
kept and made available upon request. The organization
shall perform analysis and, initiate 「corrective action」
to prevent recurrence.
NOTE Cycle time related to rejected product analysis
should be consistent with determination of root cause,
corrective action and monitoring the effectiveness of
implementation.
182
e.g. 2): 有時「客戶報怨」是客戶找碴或錯不在工廠，
雖然 「Rule #1: Customer is always right. Rule #2: If
customer is wrong, go to rule #1」。但是碰到“澳洲
來的客戶”「ㄠˋ客」怎麼辦呢？
注意 : 此處所指之nonconformities包含nonconforming
incoming materials/parts(進料不良)，所以不能只用
8.3 Control of nonconforming product來處理進料不良
(例如只做「退貨處理」)。甚至也要考慮QS-9000/TS
16949: 2002所規定的“Product with unidentified or
suspect status shall be classified as nonconforming
product (「檢驗狀態不明」或「處於懷疑狀態」之產
品均需視同不良品)” (e.g. 逾期品，前一次校驗合格
距離本次校驗NG之gage所量測過之產品…)。 183
-- b) determining the causes of nonconformities,
-- c) evaluating the “need for action” to ensure that nonconformities
do not recur,
說明: 觀念同前述對 “CA’s shall be appropriate to the effects of the
nonconformities encountered”之說明。
-- d) determining and implementing “action needed”,
-- e) records of the results of action taken,
e.g. Root-Cause Analysis:
Root Cause Analysis is a logical, systematic approach to identifying
the basic reasons (causes, mechanisms, etc.) for a problem, failure,
non-conformance, process error, etc. Whenever a significant
problem occurs (i.e. low frequency of occurrence with high cost in
time and/or money, or high frequency of occurrence), Root Cause
Analysis should be implemented.
184
The result of Root Cause Analysis should always
be the identification of the basic mechanism by
which the problem occurs and a
recommendation for corrective action. “No
corrective action required” is an acceptable
recommendation for corrective action when
properly justified. Root Cause Analysis cannot
be closed out until all required corrective action
has been developed and implemented. When
Root Cause Analysis is performed, all of the
investigation, analysis, and results (including
corrective action) must be completely
185
documented.
--(新)…to define requirements for (f) reviewing CA taken:
含「CA之效果確認」之意。
ISO/IEC 17025 4.10.2 (Root-) Cause analysis
The procedure for corrective action shall start with an
investigation to determine the root cause(s) of the
problem.
Note: (Root-) Cause analysis is the key and sometimes the
most difficult part in the corrective action procedure.
Often the root cause is not obvious and thus a careful
analysis of all potential causes of the problem is
required. Potential causes could include client
requirements, the samples, sample specifications,
methods and procedures, staff skills and training,
consumables, or equipment and its calibration. 186
Paynter Chart- The Paynter Chart is used to
demonstrate the effectiveness of corrective actions.
It has the same categories as the Pareto Chart and
identifies when changes have been made.
In some situations, problems may be connected.
Therefore, the corrective action applied to a
problem on the Pareto Chart may have an
influence on other sub-problems. The corrective
action may either improve another problem or have
a negative effect. The Paynter Chart provides a
means of evaluation, not only the problem that was
the primary focus for Problem-Solving, but also
others that might be affected.
187
The Paynter Chart
Abstract
The Paynter chart is similar to a Pareto Chart except that
each Pareto bar is split up into subgroups. This enables
you to look at what subgroups are going into the makeup
of the pareto bar and you can use it to spot trends or
troublespots. Keywords: Paynter, gpaynter, pareto
Product: Statit, 4.3 5.2
The Paynter Chart is a tool that goes beyond a Pareto. A
Pareto shows the problems with the most frequency. A
Paynter Chart shows the Pareto information but breaks
the Pareto Bars into subgroups. The Subgroups could be
days, hours or subgroups from a p chart. The examples
188
below illustrate the Paynter Chart.
This Paynter was run by restricting the number of groups to 5 and
the number of subgroups to 4. In this case it took the last 4
subgroups to plot.
189
ISO/IEC 17025
4.10.3 Selection and implementation of corrective actions
Where corrective action is needed, the laboratory shall identify
potential corrective actions. It shall select and implement the
action(s) most likely to eliminate the problem and to prevent
recurrence (i.e. 最佳解決方案)。
Common AR: 「CA/PA case was prematurely closed」，例如
「對策: 加強檢驗或訓練。效果確認: yes/結案」。
--QS-9000 4.14.1.1:
Problem Solving Methods
A Supplier shall use disciplined problem solving methods when
an internal or external nonconformance to specification or
requirement occurs.
190
When external nonconformance occur, the supplier shall
respond in a manner prescribed by the customer. Refer
to the customer documents
.e.g. DC-7D, Ford-G8D(Global 8D Analysis),
GM- Problem Reporting & Resolution (PR/R)
Procedure
--QS-9000 4.14.1.2: Mistake Proofing
The supplier shall use mistake proofing methodology in
their corrective and preventive action process to a degree
appropriate to the magnitude of the problems and
commensurate with the risks encountered.
191
Corrective Action Impact – 4.14.2.2:「也算是一種 ISO 9001:
2000之 PA」
Where applicable, the supplier shall apply the corrective
action taken, and controls implemented, to eliminate the
cause of a nonconformity to other similar processes and
products.
--(QS-9000) linked to PFMEA review/update , Control Plan &
Operators Instruction(Process Sheet) updates & “increasing
internal audit frequency” (i.e. 一種operational feedback &
learning). 詳細說明如下:
﹝Ford G8D:… ensuring that the CAP (Corrective Action Plan)
has been transposed into the FMEA , Control Plan , and
Process Sheets… Verifying that the resulting data are
brought forward into the Supplier’s FMEA, Control Plan,
192
and Process Sheets.
D7: (Prevent Recurrence)
Strategic Questions
• Was the Process Failure Mode Effects
Analysis (PFMEA) reviewed?
• Was the PFMEA revised adequately?
• Were the Control Plans revised?
• Were the Process Sheets revised?
193
QS-9000 4.17.1 When
internal/external nonconformances
or customer complaints occur, the
planned audit frequency should be
increased.
194
GLOBAL 8D
D0. Prepare for the Ford G8D Process
D1. Establish the Team
D2. Describe the Problem
D3. Develop the Interim Containment Action
(Common AR: 將此階段之Interim Containment Action 當成
Containment FMEA)
D4. Define and Verify Root Cause and Escape Point(流出點 )
(Remarks: Containment FMEA 之 Containment Controls要對
付之containment failures就是這些Escape Points)
D5. Choose and Verify Permanent Corrective Actions for Root Cause
and Escape Point
D6. Implement and Validate Permanent Corrective Actions195
D7. Prevent Recurrence
 The PFMEA was not reviewed.
 The PFMEA was not adequately revised.
 Control Plans were not revised.
Process sheets were not revised.
D8. Recognize Team and Individual Contributions
196
8.5.3 Preventive Action (預防措施)— 未發防止。
--- ISO 9001:1994之 PA被打散到ISO 9001:2000
之 8.5.3 (Preventive Action)和 8.4 (Analysis of
Data)。換言之, 原先舊版之「執行資料分析(i.e.
trending) 用以identify 是否有潛在不良/問題
(potential nonconformities), 如果有才施以對策」
之規定不變, 只是放在8.4 (Analysis of Data)。e.g.
repeated CAR’s 。
--- Trend/Pattern Analysis (evaluation of
historical data for trends and criticality)
197
--QS-9000 4.13.2.1 Prioritized Reduction Plan: The
supplier shall quantify and analyse nonconforming
product and establish a prioritized reduction plan.
Progress toward the plan should be tracked.
(considered as PA)
--QS-9000 4.1.5 Analysis and use of company level data:
The supplier shall document trends in quality,
operational performance (productivity, efficiency,
effectiveness, cost of poor quality) and current quality
levels for key product/service features…
Trends...compared with those of competitors….with
progress toward overall business objectives and lead to
action…(也是一種PA)
198
--- UL早在ISO 9001:1987至ISO 9001:1994便已清楚將
Trend Analysis歸入PA，而非CA (許多人分不清楚CA
& PA之差異).
--- the development of D/PFMEA’s 不見得就是P.A.,除非工
廠能展示有一documented system whereby data is
analysed to develop and update FMEA’s ( e.g. a
procedure and evidence of the analysis of TGW— a
review of past Things-Gone-Wrong/Lessons
Learned(e.g. high warranty, campaigns, etc.)—data to
support development of a FMEA), 那FMEA’s 之應用可
視為符合P.A.之intent.
--- the FMEA must be done before a product or process
failure mode has been incorporated into a product or
process.
199
---理論上, a before-the-event, up-front, thoroughly
thought-out and well-developed FMEA will
eliminate/minimize late change crises, ECN’s,
CAR’s….。
---FMEA是living document，但我們時常發現工廠
並沒有將後續發生的critical
nonconformities/customer complaints/TGW
reports所開之CAR連結到FMEA review & update
(common AR!)。為避免此AR之較理想之系統性做
法是在CAR form上面加一欄位“FMEA review &
update required?” ; 亦適用於QS-9000 4.17.1 之
「增加內稽頻率」…。(i.e. operational feedback &
learning)
200
Semiconductor Supplement 要求要做Containment
FMEA (CFMEA):「An FMEA which identifies critical
failure mechanisms which due to low detectability
and/or high criticality require a containment screen.」
& 「4.14.3.S(PA): The supplier should use containment
FMEA’s to facilitate and document containment
actions.」
201
Note: CFMEA是用來對付/預防 Potential
containment failure(s) 「阻隔不良流出去給客戶
之潛在失效」
e.g. IC之混料
Note: High Criticality = High Severity + High
Occurrence
 笑話一則: 某一家 IC 封測廠通過非UL 認証之
QS-9000証書，並沒有apply 「QS-9000
Semiconductor Supplement」。聽說這個現象很
普遍!
202
說明:
1) QS-9000 之 Applicability:
QS-9000 applies to providers of :
1) Semiconductors in conjunction with the
Semiconductor Supplement…
2) QS-9000 and this Semiconductor Supplement applies
to the internal and external suppliers of production and
service semiconductor parts and materials.
Every element of QS-9000 and this Semiconductor
Supplement applies to semiconductor suppliers with the
possible exception of design and /or service element.
203
3). QS-9000 Certificate Requirements:
Certificates for semiconductors shall include wording that
indicates that the requirements of the QS-9000
Semiconductor Supplement were included.
笑話一則: 某些半導體廠之QS-9000證書，沒有cite這些
wording!
4). 舉凡diodes(二極體) , transistors(電晶體) , IC’s(積體電
路) , 甚至TFT-LCD都是Semiconductors; in short, SIC
Code 3674(Semiconductors & Related Devices)所涵蓋之產
品項目都算!
204
--- Reliability Prediction (可靠度預測) 之使用
--- Processes that provide early warning of approaching out-ofcontrol operating conditions (應用一些早期預警之processes) e.g.
SPC/control charts之使用。
--- 生活中之例子: 保全系統，紅綠燈，防止 (先天遺傳) 心臟病。
FMEA:《養生秘笈》午睡有防止心臟病 (potential failure mode:
high severity ranking) 的發生作用，凡堅持每天有三十分鐘午睡
(recommended action) 習慣的人，他們的心臟病發生率
(occurrence ranking) 減少30 %。
--- Don’t expect to see or require separate procedures marked
“Preventive Action”. It is often integrated into other procedures e.g.
通常用臨時性之「專案管理」編組(Project Management)，任務
結束，小組就解散。例如一般組織常見之QIT (Quality
Improvement Team) 之編組運作。
---甚至，PA (Preventive Action) 也可以是C.I. (Continual
Improvement).
205
ISO/IEC 17025:1999
4.11 Preventive action
4.11.1 Needed improvements and potential
sources of nonconformances, either technical or
concerning the quality system, shall be
identified. If preventive action is required,
action plans shall be developed, implemented
and monitored to reduce the likelihood of the
occurrence of such nonconformances and to
take advantage of the opportunities for
improvement.
206
4.11.2 Procedures for preventive actions shall
include the initiation of such actions and
application of controls to ensure that they are
effective.
Note 1: Preventive action is a pro-active process to
identify opportunities for improvement rather than a
reaction to the identification of problems or
complaints.
Note 2: Apart from the review of the operational
procedures (也是一種 PA), the preventive action
might involve analysis of data, including trend and
risk analyses (也是一種 PA) and proficiency207
testing results.
範例:
CORRECTIVE ACTION
(再發防止)
PREVENTIVE ACTION
(未發防止)
--Eliminate an existing
-- Eliminate a potential
nonconformity
nonconformity
-- Don’t let it happen again
-- Don’t let it happen at all
-- Local in nature
-- Global in nature
-- Prevent recurrence
-- Prevent potential occurrence
-- Eliminate the cause of
-- Eliminate the cause of a
a detected nonconformity
a potential nonconformity
208
CORRECTIVE ACTION
PREVENTIVE ACTION
--Reactive (被動反應)
--Proactive (主動積極)
--Single Occurrence (單一事件)
--Data Analysis / Trend or
Risk Analysis (資料/趨勢或風
險分析) (e.g. using ---Trend
Chart—looking at trend over
time to see if there is any
potential nonconformity )使
用推移圖
(existing nonconformity/out -of-specification occurrence)
--Action is required usually
(通常需要對策)
--Action is required only
when there is unfavorable
trend. NO ACTION is
required for favorable trend.
(趨勢不好時，才需要對策)
209
CORRECTIVE ACTION
--個案CAR/G8D之有效處理
&結案
PREVENTIVE ACTION
-- CAR 處理之延伸:
CA Impact Analysis could
create an opportunity for PA–
applying the CA taken, and
controls implemented, to
eliminate the cause of a (potential)
nonconformity to other areas, or
other similar processes and
products (有效CA對策之
「水平/橫向展開」至其他地方,
或其他類似產品和製程)
210
CORRECTIVE ACTION
PREVENTIVE ACTION
-- Periodic/systematic review of current
processes or practices/operational
procedures/documentation….。
(定期/主動審查現行作業/流程/程
序書/文件…)
-- 「有效」並「活用」
Problem/Nonconformity Prevention
Tools, e.g. FMEA, Reliability
Prediction, Control Charts (SPC)…。
211
CORRECTIVE ACTION
PREVENTIVE ACTION
--Local Action
般是當地/部門之對策)
--Management Action / Judgement (一
(管理面之決策)(e.g. judgement
made & responsibility assigned during
Management Review-“Who will do
What by When”: Case closed & PA
Team dissolved when PA done).
Example:
Same idea like SPC
PA taken
(Real-time action taken)
UCL
trend
CL
LCL
15
Example:
Root Cause:
Poor training
每
月
客 10
戶
報
怨 5
件
數
0
Keep monitoring the trend
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
PA effective
Sep
Oct
Nov
Dec
time
(Just like control chart, the effectiveness for PA taken can be
demonstrated in the trend chart)
212
Remarks: Auditors add fuel to
the fire! 因為auditors本身都
不瞭解CA和PA定義及觀念之
差異 , 結果造成「The very
people who should be
correcting the users of ISO
9001 are instead validating the
error」 !
213
CA
PA
Examples of Existing
Nonconformities
Examples of Potential
Nonconformities
進料檢驗發現有26%的原料是
不良品。
生產設備A的電路板在操作
200小時之後失效 , 同時間購
買回來還有另外四部同型設備
也會有同樣之潛在失效。
今天一部機器生產的產品有
30%不符合客戶規格。
內部稽核時發現一位機器操
作員不知道如何正確填寫一份
比較複雜之品質驗收單 , 其他
3個月之內有5個客訴沒有處理。 好幾個做同樣工作之操作員也
會有同樣之潛在問題。
一個月之內 有20%之交貨批遲
交給某一特定客戶。
214
CA Procedures
PA Procedures
Accurately define an existing
problem
Accurately define a potential
problem
(正確定義現行/已發生之問題)
(正確定義“潛在問題”)
Investigate all root causes
Investigate all potential causes
(調查所有根本原因)
(調查所有潛在原因)
Identify most probable cause(s) Identify most probable potential
cause(s)
(找出/鑑別最可能之根本原因)
(找出/鑑別最可能之潛在原因)
Determine appropriate CA
(決定適當之CA)
Determine appropriate PA
(決定適當之PA)
215
CA Procedures
PA Procedures
Implement CA
Implement PA
( 執行/落實CA)
( 執行/落實PA)
Follow-up to verify
effectiveness of CA prior to
closure
Follow-up to verify
effectiveness of PA prior to
closure
(關案前之CA效果確認追查)
(關案前之PA效果確認追查)
Verify a minimum of twice
prior to closure
Verify a minimum of three
times prior to closure (PAs take
longer to effectively verify and
close)
(關案前至少效果確認二次)
(關案前至少效果確認三次:PA
需要更長時間來做效果確認)
216
CA Procedures
PA Procedures
Allow at least 1 month
between each verification
for CA effectiveness.
Allow at least 1 month between
each verification for PA
effectiveness.
(CA效果確認間隔時間至
少一個月 )
(PA效果確認間隔時間至少一個
月)
217
 Continual
-
-
(Continuous) Improvement:
“Good-Better-Best” 觀念
Is there a way that is: Better(Q), Cheaper(C) &
Faster(D)? (How can org do it better, cheaper and
faster?)
需主動積極地/持續地尋找 CI 機會，rather than wait
for a problem to reveal opportunities for improvement.
含 Breakthrough Projects (用 CFT), 如 6-sigma
Breakthrough Strategies, Re-engineering「企業再造
工程」, the use of BSC(平衡計分卡)…等之
discontinuous improvement(跳躍改善); 及 smallstep, ongoing improvement activities 之continuous
improvement(持續改善)
218
9001:2000 之 C.I. 和 QS-9000 之 C.I. 之比較.
-ISO 9001:2000 8.5.1 C.I.—The org. shall continually
improve the effectiveness of the QMS through the use of the
quality policy, quality objectives, audit results, analysis of
data, corrective and preventive actions and management
review.
-ISO
Shall develop a prioritized action plan for C.I. in
processes that have demonstrated stability, acceptable
capability and performance. (Unstable/non-capable
processes 屬於C.A.,非 C.I.)
--所以 C.I.是「好,還要更好!」。 stable/capable processes還
要更好的 Cpk (PPAP要求Cpk=1.67 時,還要C.I.); For
attribute data, C.I. 指”縮緊規格”之後之C.I.
219
PPAP要求Cpk ≥ 1.67 , 但是當Cp≥3時 , QS-9000 4.9.2
「When process/product data indicate a high degree of
capability (e.g. Cp≥3), the supplier may revise the Control Plan,
as appropriate」by 「 reducing inspection/sampling (cost) 」
也是C.I.
 4.9.3 Modified Process Control Requirements: 「In some
cases, the customer may require either higher or lower
capability or performance (see 4.9.2) requirements. In these
cases, the Control Plan shall be annotated accordingly (i.e., in
the Product/Process specification/Tolerance column of the
suggested APQP Control Plan)」。 此情況該如何 C. I.呢?
答: 以「當初和客戶PPAP核准之Capability/良率」為準 , 從事
提昇Capability/良率所做之effortsC.I.
220
Why C.I.? 其中一個原因是field failure較少，或田口的
Loss Function Mentality中的「Loss to customer and/or
society」較小 (e.g. 美國製和日本製汽車傳動軸之故事)
另，QS-9000 SPC Manual Sec. 6: ….for some processes, the
customer will be sensitive even to variation within
engineering specifications. In these instances, the value of
C.I. will not be realized until variation is reduced. 此時可能
要用到DOE及更高階之管制圖….。但這些觀念並不表示所
有不同之processes 都要如此之C.I.例如近幾年來日本工業界
已開始認真思考:「日本製」之品質是否好過頭了？用都用
不壞？！最明顯的例子是一部電視機壞了，裡面的許多
「日本製」的電子零件還好的很！(換言之，應該要的是
「適當品質」，而不是「好過頭的品質」吧！)
221
QS-9000之 C. I. 之 intent是 “好,還要更好!”(good-betterbest):
對象: Q.C.D. ;但也不能忽略innovative improvement
優先對象: Special Characteristics(管制特性)
key indicators 含 cost elements or price (e.g. 4.1.5 之”失敗
成本”, 4.9.2當長時間 Cpk3時,工廠may revise the Control
Plan)
當前述之Special Char.為variable data (計量值) 時, C.I.
means “optimizing(更佳化) the characteristics and parameters
at a target value and reducing variation around that value” 。
當前述之Special Char. 為attribute data (計數值) 時, C.I. is not
possible until characteristics are conforming. (If attribute222data
8.2.1 Customer Satisfaction (顧客滿意) & 7.2.3c
Customer Communication (…customer feedback,
including customer complaints):
-- A saying: 要讓一家飯店倒閉最簡單的方法是在櫃
檯擺幾張臭臉!「The importance of Receptionist/CS
personnel」.
-- Proactive ! (主動/積極!)
-- Customer complaints indicate low customer
satisfaction; absence of them does not imply high
customer satisfaction (亦即No news 不一定是 good
news , 也許客戶正在物色別家supplier來把你幹掉!)
223
－光靠顧客報怨和退貨 (customer complaints & returns)
資料用來量測顧客滿意度通常是不恰當也不夠的，因
為complaint data may fall short both in MAGNITUDE (a
higher proportion of dissatisfied customers exists than is
reflected in returns and complaint data通常不滿意之客戶
之數字/比率會比真正反應在退貨及報怨之數字/比率更
高) and in CONTENT (the compilation and analysis of
returns and complaints by reason may not parallel (等
同)actual customer experience客戶退貨及報怨之原因分
析及收集並不全然反應客戶真正感受/經驗)；除非
substantiated with objective evidence to demonstrate the
validity. 如果很明顯這些現成隨手可得之CS data(i.e.
complaints & returns)時常不能真正反應CS，那麼公司
就需考慮建立“顧客反應/回饋”補助系統了。
224
-當一個消費者對某一產品品質不滿意時，他可能不
會向原購買之商店或生產廠商報怨，而思將來「到
別家買」，或「買另一種品牌」，i.e.「the
merchandise does not return and neither does the
customer」
-ISO 9001 : 2000 Clauses 7.2.3 / 8.2.1 和 QS-9000
Clause 4.1.6 之比較:
a) ISO 9001:2000 7.2.3 Customer
Communication—The org. shall determine and
implement effective arrangements for
communicating with customers in relation to…c)
customer feedback, including customer
complaints.
225
b) ISO 9001:2000 8.2.1 Customer Satisfaction: As one of
the measurements of the QMS, the org. shall monitor
information relating to customer perception (心理感受)
as to whether the org. has met customer reqmts. The
methods for obtaining and using this information shall
be determined.
(Monitoring of customer satisfaction requires the
evaluation of information relating to customer
perception as to whether the organization has met the
customer requirements).
注意: 規定要monitor (i.e. observe, supervise and control,
maybe by measuring) ，就不一定非要measure不可！
226
c) QS-9000 4.1.6 Customer Satisfaction：
The supplier shall have documented process
for determining CS including frequency of
determination, and how objectivity and
validity are assured. Trends in CS and key
indicators of customer dissatisfaction shall be
compared to those of competitors, or
appropriate benchmarks, and reviewed by
senior mgm’t.
Note：Consideration should be given to
internal, external and final customer.
227
-Fulfilling
customer requirements
does not necessarily ensure high
customer satisfaction.
-Assessors must see : Process that
goes beyond customer complaint
handling alone.
228
-
Assessors might see : (The collection of customer-related
information may be ACTIVE or PASSIVE)
* Customer Satisfaction Surveys, e.g. 連鎖店(服務業)常用
* Periodic phone calls
之“Mystery Shopper”
* Customer Report Cards
(神秘顧客)
* “Customer Focus Group” Report
* Customer Visits/Meetings
(最好由senior managers去做)
* Monitor「回客率」， 收集「笑臉/苦瓜臉」，「客戶
量」， 「沒有吃完」 : e.g. Hotel、餐飲等服務業。
* Complaints/Returns
* Warranties/Service Reports
* Toll-Free Telephone Calls Report
229
CUSTOMER SATISFACTION SURVEY(客戶滿意度調查) :
(1)「…the results are usually not representative of a normal
population. This result occurs because the only people who will take
the time to fill out a survey are those who feel very strongly about a
subject and , therefore, tend to be biased:調查結果經常不能代表真
正之群體，蓋因願意花時間來填寫調查表的人往往都是一些對特定
主題感受最強烈 (i.e. 最 「爽」或最「賭爛」)之人，因而造成偏差
現象。」
(2) Survey 是一種介於 ABC (Almost Being Certain)「幾乎很確實」
和 PBC (Pretending to Be Certain) 「假裝很確實」之間的東西。
其結果會在 ABC 和 PBC 的鴻溝間擺盪 , 主要是受限於Survey的抽
樣方式 , 調查方法 , 問題的設計和樣本的大小等 , 這些執行過程若控
制不當 , 會使得調查結果產生偏誤。
230
e.g. 最近民調「是否支持一國兩制」，陸委
會及國民黨所做之長期民調結果幾乎一模一
樣:支持10%~15%，反對75%；反觀另一些
媒體所做的結果是:支持33%，甚至高達50%。
為什麼會有那麼大的差異呢？(聽說差異在問
題設計上是否有加註說明: 所謂一國兩制是指
中華民國被“吞”了！)
(3) 試想一個客戶有500個供應商，每個供應
商都要求此客戶填 CS survey，客戶可能會
說什麼？「是啊！我對你們的交貨及服務都
很滿意，但我受不了你們每家都要我填寫 CS
survey！」
231
FYI:
(1). As a minimum, 暢通的投訴渠道是滿足顧客的有效手段。如
果企業能夠迅速地受理並解決客戶的投訴，這位顧客再度購買
的機率高達95%。如果沒有投訴的渠道，企業當然省了很多麻
煩，顧客當然也無從抱怨，可是他們再也不是客戶了。
(2). 根據統計，減少5%的顧客流失，可增加100%的獲利；完全
滿意的顧客再光顧是一般顧客的6倍；獲得一個新顧客的成本是
留住舊的5倍；一位滿意的顧客會將愉快的經驗告訴另外5位，
而一位不滿意的顧客卻會將不愉快的經驗告訴另外9位。另有所
謂「口碑式推銷的3-33法則」每當有3位消費者願意將美好的購
物經驗與別人分享時，也會有33位消費者會將他們痛苦難過的
消費過程告訴他人。而根據Pareto的80/20法則，企業80%的獲
利 (or 業績 ) 來自20%的 顧客。因此如何“服侍”好existing
customers , 如何做好顧客關係管理 CRM(Customer
Relationship Management)，是優質企業刻不容緩的議題。
232
( Remarks: 何謂 CRM?客戶關係管理著重在認識
客戶，唯有瞭解客戶的往來狀況、習慣及動態，才
能提供最客製化的服務與產品。組織資源有限，應
妥善將人力、物力，分配於有貢獻度的客戶身上。
即是要落實所謂的Pareto的80/20法則，將80%資
源運用於有貢獻的20%客戶。客戶關係管理是講方
法的，傳統管理已無法滿足大量客戶資料分析的需
求，必須利用資訊科技的資料倉儲(Data
warehouse)技術，有系統的執行客戶關係管理
(CRM; customer relationship management)工作。
簡單的說就是企業為了滿足顧客的需要 , 運用
233
「資料庫管理」的技術 , 研究顧客的購買行為 與習
慣 , 採取一對一的行銷方式 , 在最適當的時間 , 透過
最適當的管道 , 以最適當的價格 , 提供最適當的產
品或服務 ; 換言之 , 只要能夠把偶然交易的顧客變
成長期忠誠的顧客所做的一切努力和活動均包括在
內。 CRM不僅讓企業能夠降低成本 , 推出更有價
值的商品或服務 , 以及更有效的行銷活動 。 更重要
的 , CRM能夠讓企業快速的抓住市場的變化 , 滿足
顧客的需求 , 獲得持續領先的競爭優勢 , 如果結合
BSC之使用，因CRM而top-down下來的「願 景
(Vision) → 策略 (Strategy) → 目標 (Objectives) →
量度 (Measures) → 伸張指標 (Stretch Targets) →
行動方案 (Initiatives)」策略規劃/ 管理會更「知行
合一」)。
234
(3). 了解顧客: 最了解商品與服務的專家並非企業
內部的員工，而是顧客，唯有以他們的觀點去了
解他們的世界，才能與顧客們建立長久的夥伴關
係。
(4). 在管理上，先追求滿意的員工，再同時追求
顧客的滿意，以達到股東滿意與社會滿意之全方
位經營策略境界。
亦即，ISO/TS 16949:2002 6.2.2.4之 規定如下:
235
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 。)
236
The organization shall have a process to
measure the extent to which its personnel are
aware of the relevance and importance of
their activities and how they contribute to the
achievement of the quality objectives.(組織需
有一流程來量測其員工知悉他們所從事工作
之相關性及重要性之程度 , 並且要量測他們
是如何貢獻至品質目標之達成)
簡單地說，“No happy employees (internal
customers), no happy customers (外部客戶)!!”
「有快樂的員工才有滿意的顧客!」
237
e.g. 激勵員工參與提案改善: (a) 建立一套完
整之提案獎勵辦法，(b) 塑造認同感，(c) 提供
改善技巧訓練 & (d) 借用競爭的壓力來刺激。
e.g. BSC 或 BOS 之願景 / 策略目標展開 (toptown)至個人目標 (personal objectives) 或
personal scorecard 之deployment process: To
make strategy everyone’s everyday job。
e.g. 員工滿意度調查.
e.g. 內部稽核.
e.g. R.M./G.M. Briefing & Award……
238
張忠謀曾說: 培養人才是很重要的做法，而獨立且
具批判性的思考能力、終身學習、以及通識教育
等 , 都有助於創新人才的培養。至於企業中的實際
做法 , 除了持續獎賞創新並有成效者外 , 對於嘗試
創新卻不成功的人則不應處罰 , 因為他們也可能有
成功的時候。張忠謀表示 , 事實上 , 在競爭激烈的
產業環境中 , 因為創新不成功 , 導致的虛度光陰 ,
對這些人而言 , 不罰也已經是罰了。真正該罰的是
長期不願創新的人。
但是當員工和顧客的利益發生衝突時，怎麼辦？
(“A航空公司優先送出員工的行李” vs. “B航空公
司優先讓顧客辦理check-out”之小故事)
239
Customer Delight (CD):
•現今美國還想有更進一步的突破`，就是企
業希望完全了解「顧客」，受到「顧客」的
支持，使「顧客」成為FANS，這種顧客主義
的想法將會以「超越滿足顧客」的形態展開。
為了顧客，它企圖呈現一切創意，而卓越的
智慧與商品樣式都是因顧客而存在，企業之
間激烈的競爭將開始，不再只是以所謂的顧
客滿意度 (CS) 為目標。為了讓顧客選擇該企
業的商品，並進而對企業產生忠誠度，各大
企業無不大展身手。
240
•在競爭激烈的今天， 「重視服務」已是大
家的共識。 「做好服務」只是讓企業生存的
要件。但企業若想成功，更需要「非常服務」
才能出類拔萃。這也是美國目前企業界最流
行的服務概念，稱為「P.O.S-Positively
Outrageous Service」。到底什麼是P.O.S.?
簡單的說: 客戶所得到的服務是完全的出乎意
料(unexpected)，甚至是終生難忘的。 「滿
意的客戶」(via GS-Good Service) 不具有實
際價值 (只是基本條件)，只有「忠誠的客戶」
才是公司真正的資產(Satisfied customer is
worthless. Royal customer is a real asset)。
241
ISO 9004: Organizations depend on
their customers and therefore
should understand current
and future customer needs,
should meet customer
requirements and strive to
exceed customer
expectations (i.e. 「顧客喜悅」
customer delight.) 。
242
再談「PDCA循環」當中
之
“d” Segment「執行」!
243
文件架構 (Clause 4.2 of ISO 9001:1994 & ISO
9001:2000) :
Quality
Manual
(品質手冊)
Procedures
(程序書)
Job Instructions
Instructions
Job
(工作說明書／作業指導書)
(工作說明書/作業指導書)
Other Documentation
(其他文件)
Level 1 (一階)
Defines Approach & responsibility (定義“
方式”和 “權責”)
Quality
Manual
(品質手冊)
Level 2 (二階)
Defines Who, What, When (定義“誰
”,“什麼”＆“何時”)
Level 3 (三階)
Answers How (回答“如何做”)
Level 4 (四階)
Prompts recording of information, e.g.
forms, tags, labels. Once recorded, the
item may become a quality record (未
填上資料／記錄之前之空白表單，標
籤，一旦填上資料/記錄之後，就變成
品質記錄)
244
文件和品質記錄之差異
- ISO 9001:1994/QS-9000 對 Documents 和 Quality
Records 區分的較清楚: 常用之四階文件架構中 之
第四階文件之空白表單, 標籤等 (forms, tags, labels
等) 是為了執行 QMS 時，常用來記錄資料之用之
文件“Documents” (尤其是一些所謂的“說明書式
的表單” Self-Instructional Forms, 例如表單本身
含有三階 Work Instruction, 內容如
Sampling/Acceptance criteria 之檢驗記錄表); 當這
些空白之 Forms, Tags 或 Labels 一旦填上資料, 就
變成了Quality Records.
245
- ISO 9001:2000 對文件 及 記錄之區分較為模糊,
例 如  Clause 4.2.1 – The QMS documentation
shall include….e) records required by
this International Standard
 Clause 4.2.3 – ……Records are a special
type of document ….
e.g. 常見的有 Business Plan (經營計劃),
FMEA’s, Design Records (設計記錄),
ECN’s (工程變更通知單), PPAP Records (“生產
性零組件核准程序”相關記錄), Meeting Minutes,
AVL (供應商核准名冊) ….等既像記錄 , 又像文件!

246
笑話一則: 曾有一家PCB材料廠，雖然經本
人三顧茅廬，還是不敢找UL做QS-9000認
証。最後，他們還是決定沿用原ISO 9000發
証單位做QS-9000認証，結果竟然「只有一
個缺點」就過關了！閣下想知道是何缺點
嗎？ 是「某一個部門使用了一張過期之表
單！」更妙的是，他們的客戶之一(取得UL
QS-9000認証之某PCB廠)到他們工廠去執行
QS-9000 4.6.2.1 Subcontractor Development
(供應廠商評鑑) 時，發現他們的APQP實在
有夠爛！
247
我有話要說: UL是如何看待「用錯表單」之缺點？
「在某一部門稽核了老半天只發現一張表單用錯，UL
auditor會進一步看看新舊表單之差異是什麼？如果差
異只是一些無傷大雅之Typo error或表單格式稍微變
更，完全和此表單會產出之output (i.e. 品質) 無關，則
UL通常不開AR (充其量也不過是observation 或“道
德勸說”一下而已)。如果硬是要開AR，恐會落得
“overkill/nit-pick”之名！但是如果有好幾個部門都被
發現了這種「用了舊版之表單」之缺點，則會構成AR
(i.e. 文件之distribution /revision control有問題)。當然，
如果新舊表單之差異會影響output (品質)，e.g.常見之
Self-instructional Forms上面之criteria或作業步驟/重
點變更時，則亳無疑問UL會開AR。」
248
--“How detailed does such documented procedure have to be?”
→答案在4.2.1之 NOTE 1和 NOTE 2
NOTE 1: “Documented procedure” means that the procedure is
established, documented, implemented and maintained.
NOTE: 2: 不同公司間之「文件化」深淺程度(the extent of QMS
documentation)不一，因為~~
a). 公司大小，產品/活動種類不一
b). processes & their interactions之複雜程度不一
c). 人員之資格，訓練，勝任程度不一(the competence
of personnel)
e.g. Nuclear power plant vs. 小麵館
Hint: New process
Existing process
PDCA…
CAPD…
249
ISO/IEC
17025:1999 International, regional or national
standards or other recognized specifications that contain
sufficient and concise information on how to perform the
tests and/or calibrations do not need to be supplemented
or rewritten as internal procedures if these standards are
written in a way that they can be used as published by
the operating staff in a laboratory. It may be necessary
to provide additional documentation for optional steps in
the method or additional details.(外來文件只要operators
看得懂/會使用 , 不需重寫成內部文件)
ISO/IEC 17025 4.3.2.2 「…. Documents are
periodically reviewed…」(需要定期審查文件…:可視為
250
一種PA , 雖然ISO 9001無此要求)

ISO/IEC
17025 4.3.3.3
If the laboratory’s documentation control system allows for the
amendment of documents by hand pending the re-issue of the
documents, the procedures and authorities for such amendments
shall be defined. Amendments shall be clearly marked, initialled
and dated. A revised document shall be formally re-issued as soon
as practicable.(如果文管規定准予手寫方式變更文件內容時 , 其
程序及權限須予以規定。變更的地方要標示 , 簽名並押日期。變
更之文件需儘快正式發行。)
ISO/IEC 17025 4.3.3.4
Procedures shall be established to describe how changes in
documents maintained in computerized systems are made and
controlled.(公司文件電子化時 , 其文件變更需建立程序規定如何
進行文件變更。)
Remarks: 雖然 ISO 9001無上述一些 ISO/IEC 17025 對文件管制
之要求 , 但各位先進覺得這些要求對你們的 QMS 都不適用嗎?
251
Document/Record Control 之重要性: 君曾否聽聞
用錯舊版(過期) 文件會死人之事件 ? (美軍攻擊
科索沪, 誤炸中國大使館事件: 美方說「用錯了舊版地圖」?)
“ Quantitative” (定量的) vs. “Qualitative” (定性的)
Objective Evidence (客觀證據) :
* What we saw and what we heard 「看到的」 及
「聽到的」
* Data supporting the existence or “verity”(事實)
of something.
* Objective evidence may be obtained through
observation, measurement, test, or other means. 252
* 當然, Objective Evidence 包括 quantitative 「定量的」
information, 如 records, meeting minutes….等.
* Objective Evidence 亦包括qualitative 「定性的」
information, 即 verity (事實) of something,
如 operator/top management interview 結果,
practices observed….等。
e.g. Employees may be tested for effectiveness of company
communication programs (e.g. Clauses 5.1a/5.5.2c/5.5.3…). ※
But if employees/operators don’t understand those PPM/SPC
charts posted on the shop floor, this could be a problem. (If this
is the communication method adopted by company).
(可測試員工用以瞭解公司之溝通programs是否有效 , 例如訪
談作業員知不知道現場牆上貼出來之PPM/SPC charts代表何
253
意。)
淺談
Retrieval (救回，取回，恢復) of Records--
4.2.4 Control of Records:…Records shall remain
legible, readily identifiable and retrievable. A
documented procedure shall be established to
define the controls needed for the identification,
storage, protection, retrieval, retention time and
disposition of records.
--全盤考慮各種記錄之重要性，如該記錄遺失或毀
損了，會對公司/QMS造成那些影響，而採取適當
之storage及protection方式/措施。
Noncritical Records—貯存在一般檔案櫃也許就可
以了。
254
Critical Records—應考慮防火，防震，防水，
磁片之備份(backup of records)，該備份之
protection(總不能將重要之備份就放在電腦旁
吧？！)，甚至考慮採行Disaster Recovery
Plan(雖非ISO 9001之要求)。
e.g. 汐止東方科學園區大火時，大家都在搶救
(retrieve) 文件 & 記錄; 美國 New York 之911
恐怖攻擊造成美國証管會之文件/記錄大浩劫！
本公司電腦遭竊…
笑話一則: 某一CB對某一“準備換証給別家
CB”之工廠開一個缺點「調閱某一記錄之等待
時間過長….云」
255
→甚至可由record keeper來訂定其管
制方法，只要該方法不會對QMS之推
行造成significant/negative impact.
e.g. ABC公司在品保手冊中說“由各
個record holder/keeper自行決定適當
之記錄處置方法(disposition)”亦無不
可，只要該方法不會對QMS造成
significant/negative impact。
256
但是，e.g.如果auditor發現公司之客戶要求all design records
must be shredded，而公司並沒有如此做時，則另當別論。
→如果auditor發現公司時常找不到records，或很難找到
→Maybe an AR!
FAQ: 那些記錄需要列入4.2.4管制 (Identification of records)？
兩項基本判定準則: to provide evidence (1) of conformity to
requirements, and (2) of the effective operation of the QMS.
所以 , ISO 9001條文當中有提到的「Records …shall be
maintained」，一定要列入管制，全部列出如下:
5.6.1 管理審查記錄
6.2.2 教育訓練(技術/經驗)記錄
7.1
(必要時)產品實現流程符合要求之記錄
7.2.2 合約/訂單審查記錄
257
7.3 設計記錄(含設計輸入、設計審查、設計驗証、設計驗收與設
計變更等記錄)
7.4.1 供應商評鑑記錄
7.5.2 (必要時)特殊流/製程相關記錄
7.5.3 產品特定追溯標示之記錄
7.5.4客戶財產(客供品)遺失 , 損壞或不適用時之記錄
7.6 儀器校正記錄
8.2.2 內部稽核記錄
8.2.4 產品監督量測(是否符合允收標準)之記錄
8.3不 良品之不符合性質及後續採取對策之記錄
8.5.2 矯正措施所採取對策之結果之記錄
8.5.3 預防措施所採取對策之結果之記錄
(問: 8.2.1 CS records需列管嗎？)
258
ISO/IEC 17025: 1999
4.12.1.4 The Laboratory shall have procedures to
protect and back-up records stored electronically
and to prevent unauthorized access to or
amendment of these records.(品質記錄電子化時 ,
要有程序規定如何保護及「備份」記錄 , 以及如何
預防非法入侵或修改這些記錄。)
e.g. 最近報導之「12吋晶圓之重大技術外洩事
件」…可用「程序性保護措施: 針對技術資料進行
分級管理 , 避免不相干人員接觸業務機密 ; 和員工
簽訂工作保密契約…」,「硬體鎖定加密技術: 將機
密資料鎖定在特定之電腦硬體上 , 即使資料外流 ,
259
也無法開啟瀏覽!!」
4.12.2.1 The laboratory shall retain records of original
observations, derived data and sufficient information to
establish an audit trail, calibration records, staff records
and a copy of each test report or calibration certificate
issued, for a defined period. The records for each test or
calibration shall contain sufficient information to
facilitate, if possible, identification of factors affecting the
uncertainty and to enable the test or calibration to be
repeated under conditions as close as possible to the
original. The records shall include the identity of
personnel responsible for the sampling, performance of
each test and/or calibration and checking of results. (Lab
需要保留原始 測試/校驗數據…)
260
4.12.2.2 Observations, data and calculations shall be recorded
at the time they are made and shall be identifiable to the
specific task.(在取得「測試/校驗之數據 , 計算及觀察結果 」
當時 , 就要立刻記下來 , 而且要能鑑別出它們是為了哪個特定
工作而產生。)
4.12.2.3 When mistakes occur in records, each mistake shall be
crossed out, not erased, made illegible or deleted, and the
correct value entered alongside. All such alterations to records
shall be signed or initialled (and dated) by the person making
the correction. In the case of records stored electronically,
equivalent measures shall be taken to avoid loss or change of
original data. (修改測試或校正記錄 , 不能用立可白或塗掉 ; 必
須由修改之人將錯誤的地方「劃掉」crossed out , 並在那個地
方簽名)
(Remarks:「Why above? Why 保留原始數據/記錄?」「想一
想 , 萬一有一天因商業糾紛需打官司時之呈堂証物….」) 261
(Appropriate) CONTROL 之觀念 :
 是一種“value:confidence/risk level”
consideration.
 「過猶不及」都不好!
 Adjustable based on performance!
(hint: CA-PDCA cycle for existing process/
control!)
262
A) 懸掛現場之 「 書面式作業標準/圖片/照片」
(Documented Job Instructions/Operators
Instructions/Workmanship Criteria….等)。e.g.使
用數位相機  需符合 ISO 9001:1994 之 Clauses
4.5/4.9/4.10….等, 或 ISO 9001:2000 之Clauses
4.2.1/7.5.1….等.
笑話一則: 某家電子廠在某家ISO 9000 Registrar來
做年度追查之前，趕緊將懸掛現場之「作業標準/
圖片」收起來，因為該Registrar之auditors 不接受，
「圖面式之作業標準」懸掛於現場…。
263
另某一大型Metal Stamping廠，將作業標準用鐵線
串起來懸掛於4米高之沖床機台上，就如同晒衣服
一樣，operators需藉助堆高機才能看得到那些作
業標準之內容…。(據說是為了滿足某一OEM車廠
之要求)。更離譜的是，作業標準之內容和實際作
業方式不一致…。
又有一個工廠之生產線在某一CB之auditor來稽核
之前，匆匆忙忙將作業標準懸掛起來，auditor走
了之後，又立刻拆下那些作業標準…。
Common AR:「掛好看的」「掛給auditor看的」
→標準書上面寫的內容根本和Actual Practice不一
264
致！
QS-9000 4.9.1 Process Monitoring and operator
Instructions—
The supplier shall prepare documented process
monitoring and operator instructions for all employees
having responsibilities for operation of processes. These
instructions shall be accessible at the work station.
NOTE: Job Instructions should be available at the time
needed without disruption to the job being performed by
the operator.
※ Training/Qualification can replace work instructions,
but training can not replace specifications. e.g. if 外科醫
師開刀時 , 需要參照掛在牆上之Job Instructions , 病人不
早就「掛」了才怪！
265
B) 放置/懸掛現場之顏色/色澤之比對標準也
是一種workmanship criteria , 如色卡 ….
(Masters for colors, grain, gloss,
texture……..)
 需符合ISO 9001 : 1994 之Clause 4.11/SO
9001 : 2000 之 Clause 7.6/QS-9000 之
Clause 4.9.6 (不需要符合文件管制 , 否則會
變成overkill 或 nitpick)
266
笑話一則:
最近又一overkill之實例，某一Registrar之QS-9000 auditor開
了11個關於品質手冊之缺點，全部內容都在描述組織之品
質手冊不夠完整地描述所有QS-9000之規定(他的意思是要
詳細到如同二，三階文件一般)。因為這位仁兄看到QS9000 Implementation部分有一段話: All requirements of QS9000 are to be incorporated in the supplier’s quality system and
described in the supplier’s quality manual. QS-9000 is an input
requirement for development of a quality manual. 可是他忽略
了QS-9000 Approach部分另有一句話: “All QS-9000
requirements shall be addressed in the quality system
documentation, but not necessarily by individual procedures.”
及QS-9000 4.2.2 Quality System Procedures: The supplier shall
prepare documented procedures consistent with the
requirements of this int’l standard….,及Quality System
Documentation Progression之概念。這是新手或訓練不良之
267
auditor最常犯之錯誤—read too much!
更妙的是，工廠書面答覆給這位仁兄說這些詳細作
業都在二或三階之某些特定文件述及，這位仁兄都
不接受！茲舉兩例這位仁兄所開之缺點如下:
 手冊第X頁第X節未述及管理審查記錄應予以保存
(4.1.3)。(工廠書面答覆說「已於第二階品質記錄
管理辦法 x-xx-x述及」，但不為該仁兄所接受)
 手冊第X頁第X節未述及被核准之物料的運送容器
的標示 (4.13.4)。(工廠書面答覆情節同上…..)。
:
:
你能相信嗎？他共寫了11項這種缺點！
這位仁兄真是“殺過頭” (overkill)了！
然而工廠怎麼辦呢？「改也不是，不改也不是！」
268
C) Those famous last words, “as
appropriate”, “as practicable”, “as
applicable” or “appropriate…..”
indicated in ISO 9001 : 2000.
D) shelf-life control 之 shelf-life
limitation (儲存期限) : 以 Date of
Manufacture (非 Shipping Date ) 起算
才合理 (常見之 minor AR)
269
E) Process Monitoring Equipment (製程參數錶)需校正
嗎？
請先回答下列兩個問題:
(a). 公司是否訂定特定參數之監控範圍 (specific
process parameters stay within specified ranges, as a
means of controlling the process and preventing
nonconformances)?
(b). 假如這些參數脫離了監控範圍，會影響產品品質
(not necessarily final product quality but in-process
product quality)嗎？
如果對上述(a) 和 (b) 兩問題之答案都是 yes，那麼
可能該 process instrument就需校正了。
270
e.g. --某一工廠之metal cutting machine之壓力錶，其
SOP規定壓力需控制在200psi以下，但是當auditor問工廠
時，被告知是該machine之OEM原廠建議，壓力維持在
200psi以下，是為了更能延長機器使用年限；但如果壓力
超過200psi，並不會影響產品品質auditor判定該壓力錶
不需校正！(Answer to (a) is YES, but answer to (b) is NO).
--某一塑膠射出成型廠，其SOP規定射出機之開始溫
度和壓力需set up在某個範圍。一旦set up好， SOP要求
做首件檢驗/確認(First-article inspection)，OK之後，
operators在molding階段可以視in-process inspection狀況
而調整settings，因此工廠之method of controlling the
process is through the first article and in-process
inspectionsAuditor判定該instruments不必校正！
(Answer to (b) is NO)
271
--某一CD plating & coating process廠，SOP規
定某些critical parameters需保持在特定範圍。
Auditor問工廠:「如果parameters超出range，
會有何影響？」工廠回答說「可能會造成品質不
良，但不良品會在final inspection被挑出來」，所
以工廠 argue說不必校正。Auditor進一步assess此
狀況，並應用他對此產業之瞭解而確認「當
parameters went outside the ranges時，會對disc之
品質造成嚴重影響(雖然只是in-process product
quality)，因此判定這些控制儀錶要校正，同時他
也向工廠強調the value that this calibration will
have in assuring a controlled process」
272
--日本之自動化電線押出廠/ 塑膠射出成型廠: 在完全
environentally-controlled( i.e.在恆溫恆濕的作業環境)下生產，
一個operator負責操作多部押出機/射出機，各個不同機種之
押出/射出(操作)條件都標準化….。
--UL基本上會尊重工廠之專業，但如果工廠不願意校
正之理由是「太麻煩」，「這些參數錶太多了」，這樣不好！
正確做法是用Cross-Functional Team來針對工廠所有這些
instruments用上述原則，risk/benefit原則，做一深入之
assessment，來決定那些需要校正(i.e. QS-9000之APQP流程
中之一個stage!)
F) QS-9000:
首件檢驗/確認(First-piece inspection; verification of Job SetUp), 自動檢測 (Auto testers)等需要放入Control Plan嗎？Yes,
normally , 因為 High detectability (detection ranking 為2).273
G) 常見之安規(UL或歐規)要求之100% Hi-pot test
(Dielectric Voltage Withstand Test)之Hi-pot
Tester(耐壓測試機)，在每次開機前要做functional
check(功能點檢)。萬一不做的話，是否違反ISO
9001相關規定嗎？
答:Yes, 請看 7.2.2 Contract Review & 7.6 Calibration
兩條文之規定。
H) How to control “outsourced” processes (如何管制
“外包”的流程？)
Remarks: 似乎ISO 9001:2000所有processes (甚至包
括內部稽核) 都可以outsourcing…。但是對TS-2而言，
應該不能將所有production process外包出去!
274
--當組織對產品實現負全責時，即使組織將主要流程(e.g.
設計開發，製造….等)外包出去，也不能將這些外包作
業排除在QMS之外。相反地，組織必需要能展示有執
行充分管制，用以確保這些外包作業都有符合ISO
9001:2000相關規定。一般而言，供應商(外包商)管理/
管制之深淺程度(extent)或優先順序(prioritization)取決
於 三要素:
(a)供應商作業(外包作業)之重點/性質以及牽涉之
risk/confidence level (value) considerations,
(b) 供應商(外包商)之(品質/交期)表現(Supplier’s
quality/delivery performance)，和
(c)所供應原物料(外包作業)之重要性(the importance of
materials/services supplied)。
275
例如，管制方法可能有:
a) the specification and/or validation of
processes as part of the contractual
agreement with the supplier (在當初和外包
商簽約時就已雙方明訂外包process之規格
及/或process認可/認証)
b) Requirements for the supplier’s QMS (對
外包商之QMS之要求，如取得Accredited
ISO 9001:2000)
c) On-site inspections or verifications, and/or
audit (對外包商進行現場檢驗/驗證及/或現
276
場稽核…等)
最重要的是，不管採行那種方法，都一定要用條文7.4 (採購) 來monitor
( i.e. PDCA之C) 這些外包作業之output (輸出) adjustable based on
performance! (hint: CA-PDCA cycle for existing control/process!)。
TS-2 4.1.1 Ensuring control over outsourced processes shall not absolve the
organization of the responsibility of conformity to all customer
requirements.
IATF guidance to TS-2 4.1.1 General requirements – Supplemental
When the organization outsources, it is not permitted to delegate the
technical responsibility. Particular attention should be given to the
Product and Process Design and Development (Section 7.3). As an example,
conformance with the customer part approval process, including all inhouse or outsourced activities, is the responsibility of the organization.
FAQ: 「公司用郵寄或透過 Internet 方式將 Drawings/ Specifications 分發
給 vendors，需要 venders 簽認/寄回舊圖嗎？」
答: 不見得! 注意hint: CA-PDCA cycle for existing control/process!
277
 Centralized Control (中央管制) vs. Decentralized/
Local Control (當地/地方管制)
e.g. Corporate (Multi-site ) Registration vs. “One
site/One Certificate” situation
FAQ: 本公司之「公司組織圖」及「經營計劃」因變
動太頻繁，因此我們並沒有將它們納入DCC做文
管，可以嗎?
答: Why not?只要能符合4.2.3文件管制之intent即可，
常見之例子還有大公司之三階SOP’s，或全公司只
有一個人在使用之文件(e.g.全公司只有一位採購，
他所用之AVL…)，不見得所有文件都要放在
DCC(Centralized control)。
278
 Site
vs. Remote Location
Site : 認證範圍之主要場所 , 通常指有附加價值活
動發生之生產或服務提供之場所, e.g. 製造工廠
Remote Location : Site 之外之遠距, 支援性場所
或功能.
(e.g. R&D, Sales/Marketing, Warehousing, Tooling
Facility to Plastic Injection Molding….等)
Remarks:少用Off-site這個字來代表遠距之支援性
場所/功能，因這個字本身同時隱含著site或Remote
Location 之意!
279
 認證範圍(Scope of Registration /Certification)
IAF Guidance 3:….. 新版ISO 9001:2000之証書必須很
清楚寫出品質管理系統 (QMS) 所涵蓋之範圍 (scope)
，必須“清楚”到不可以誤導 (mislead) 客戶之程度
；而且必須確定使用者或客戶 (user) 都有明確之資料
(information) 能讓他們看出認証範圍 (scope of
certification/registration) 涵蓋了那些產品 (categories
of product) 和那些產品實現過程 (product realization
processes)。特別是認証範圍之敘述 (scope statement)
必須很清楚講出產品設計/開發之責任 (the
responsibility for product design and development) 和其
他主要之實現過程 (other principal realization
processes)，例如製造 (manufacturing)，銷售 (sales)
280
和服務 (service) 等。
-笑話一則: 某一家「知名」Registrar之QS-9000認證之認証範圍敘
述實例 –
“Mfg of automotive components & accessory parts” ,
(汽車零配件之製造)
“Mfg of plastic injection molding parts & tools”,
(塑膠射出件及模具之製造)
“Sales & mfg of automotive electric components”
(汽車電機/電裝零件之製造與銷售)
(三大問題 : too generic/general , tools 不能放入QS-9000 scope &
“Sales” 之不當使用造成 customers 之 misleading)
a)條文7相關要求之“排外” (the exclusion of clause 7
requirements)可以是適用於一部分或全部認証範圍之產品。當有
任何排外(exclusions) 成立時，組織之品質手冊 (Quality Manual)
必須清楚說明排外之情況，而且認証公司在正評 (certification
audits) 及後續之追查評鑑 (surveillance audits) 時，必須去審查確
281
認該排外之有效及正當性 (validity)。
b)當組織有責任 (has responsibility for) 並實現 (realize) 或委外
(outsource) 產品之設計與開發 (design and development process)，
那麼認証範圍之敘述 (the scope statement for
certification/registration) 必須清楚寫出 “Design of….” (“…..的
設計”)，“Development of…..” (“….的開發”)，或“Design
and development of…..” (“……的設計與開發”)
c)為了確保認証之透明度 (In order to assure transparency of
certification/registration)，下列之句子必須出現在新版ISO
9001:2000之証書上面:
“為了進一步澄清本証書之認証範圍及ISO 9001:2000相關要求
之適用性，歡迎向本公司諮詢” (“Further clarifications
regarding the scope of this certificate and the applicability of ISO
9001:2000 requirements may be obtained by consulting the
organization.”)
笑話一則:我看過幾家CB所發生之ISO 9001:2000證書沒有cite這
282
句話!
d) Corporate Design Center ( Clause 7.3)-當被認証ISO 9001:2000之製造工廠(Registered
Site)之「產品設計」是來自於(遠距之)Corporate
Design Center時 , 如果這兩個單位之「管理架構/
系統/報告架構」(Management
Structure/Reporting Structure/QMS)是完全獨立
的 ; 換言之 , 亦即 Corporate Design Center 並非
Registered Site 之QMS之一部分 , 也就是
Registered Site 對於在Corporate Design Center
所從事之「產品設計活動」並沒有任何「責任」
或「管制」, 則此製造工廠(Registered Site)之
ISO 9001: 2000認証可將Clause 7.3(設計與開發)
排外。
283
此時 , Registered Site需要負責和Corporate Design Center
之間之所有Clause 7.3 interfaces , 而UL auditors必需稽核
這些interfaces。此種情況之認証範圍之寫法為「 The
manufacture and design validation of X in accordance with
design specifications provided by ﹝Corporate Design
Center﹞」。
e) Corporate Sales Office(此Sales Office 完全負責和最終
客戶之間之interfaces)/ Clause 7.2
觀念和要求同上！
此時Registered Site 需要負責和Corporate Sale Office 之間
之所有Clause 7.2 interfaces , 而UL auditors必需稽核這些
interfaces。 Scope 寫法「 The manufacture of X in
accordance with specifications provided by ﹝Corporate
284
Sales Office﹞」。
*何謂「兩個單位之管理/報告架構是獨立或非
獨立的」? 請看下述Warehouse Location 之
「非獨立」之scenario, 即可明白:
f) Warehouse Location (Clause 7.5.5) 通過UL ISO 9001:2000認証之「製造工廠」
(Registered Site)出貨至遠距之 「發貨倉庫」
(distribution warehouse), 並且「從出貨碼頭
(shipping dock)至發貨倉庫之間之責任, i.e.
Clause 7.5.5 」是屬於此製造工廠, 當然UL就
必須稽核這部分之activity。
285
進一步 review 此製造工廠之「管理/報告架構」
(Site Management Structure/ Reporting
Structure)發現此發貨倉庫之管理及作業人員都
是直接「報告」給製造工廠之廠長, 且其「品質
管理系統規劃」(QMS planning),「品質目標及
展開之行動計劃」(Quality objectives and
strategic operation plans)都是直接由製造工廠
來控管 。
此情況代表此製造工廠負責並管理該發貨倉庫 ,
亦即「這兩個單位之間之Management
Structure/Reporting Structure/QMS並非獨立
的」, 那麼UL必須安排去稽核該發貨倉庫。286
*重點: 不管「組織之責任」(organizational
responsibility)為何 , UL強烈建議將所有
support functions/activities 納入 QMS 之
中 , 則附加價值更高(如同QS-9000
Applicability 之要求)!
笑話一則: 某家PCB廠取得某家CB之TS-1
認証，竟然是那家PCB廠配合 ISO 9000 顧
問之輔導，將本身所擁有的5個offsites/remote locations (從事PCB製程之一
部分) 全歸入 7.4 供應商/外包廠管理，
「偷吃步」….
287
下列需有stronger Purchasing Control (亦即更嚴
格之供應商評估與選擇 Supplier Selection &
Evaluation), Clause 7.4 of ISO 9001:2000 A) “The procurement, inspection, packaging,
storage and delivery of ….” (For PFR product
「買了又轉賣」 之產品)
B) “The management of outsourced (product
name) production/design activities” (外包
“outsource”大部份之主要的product
realization processes 如 design, manufacture,
installation, servicing…時，可以用這種scope
statement之寫法) (Remarks :此種 scope 之
288
SIC code 為 7389)
* 注意 : UL has always reserved the
right to visit outsourced processes.
(UL QRS Program Requirements
will be revised to include this
requirement). And UL assessment
would focus upon management of
outsourced activities.
289
Limited scope 可以被允許, 但是Quality
Manual, other publicly available documents
(如 marketing materials,
certification/registration documents) 要
清楚載明。
- Service/Installation activities 在某些情況,
可被視為是另一種 “產品” (product), 因
此, 可被從QMS scope 排外。不過 , 要是會
引起 misleading, 或 買賣雙方之contracts 明
白載明含 Service 或 Installation時, 則不能
排外。
-
290
缺點分類 :
a) Observations / OFI (Opportunity for
Improvement) –
ISO 9001: 2000 因為太 flexible, 可能會
有不少observations。
b) AR (Action Request)
- Minor
- Major or Systemic Breakdown
291
QS-9000對重大缺點之定義如下
A MAJOR NONCONFORMITY is either:
-The absence or total breakdown of a system to
meet a QS-9000 requirement. A number of
minor nonconformities against one
requirement which when combined can
represent a total breakdown of the system and
thus be considered a major nonconformity. (符
合特定QS-9000之規定之system不存在或整個
失效。對特定QS-9000規定，多數同性質之輕
微缺點累積起來亦視為重大缺點。)
292
-Any
noncompliance that would
result in the probable shipment of a
nonconforming product. A condition
that may result in the failure or
materially reduce the usability of the
products or services for their
intended purpose. (會造成可能將不
良品交到客戶手上之任何“不符
合”/“缺點”)
293
-A noncompliance that judgment and experience
indicate is likely either to result in the failure of
the quality system or to materially reduce its
ability to assure controlled processes and
products. (由判定及經驗得知，當一個「不符合/
缺點」可能會造成品質系統之失效或明顯地降低
能確保製程和產品都在管制之下之能力。這種缺
點亦視為重大缺點)。
笑話一則: 前述那位仁兄，這回又開了一個他將
之歸類為minor之缺點「產品編號xxx專案追蹤項
目，不良率達20%仍判定為允收。」各位先進，
您覺得這個缺點是minor nonconformity (輕微缺
294
點)嗎？
•
關於文件化要求: 只能開AR against 九項必要文件
需求, 不能開AR against ISO 9001 : 2000 Clause
4.2.1d…..QMS documentation shall include d)
documents needed by the organization to ensure the
effective planning, operation and control of its
processes….亦即 AR 如 “The practice of ….not
procedurally addressed “ 是不能再開了! (應該開俱
体發現有 adversely affect quality and/or delivery ，
or customers are dissatisfied 「造成產品品質不良，
交期延誤，或客戶不滿意」且沒有採行CA plan 之
事證之 AR, against ISO 9001: 2000 其他相關條文,
由工廠去做 AR / root-cause analysis, 如果 root cause
是 lack of document(s), 則才由工廠去建立所需之
Documents/Operator Instructions…等)
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Product (產品) :
Result of a process
分為 : Hardware (硬體), 例如電子零件
Software (軟體)
Services (服務)
Processed Materials
System 觀念
Set of interrelated or interacting elements
(Family of processes; QMS processes)
296
 QMS /Process / Product audits 觀念
Monitoring and Measurement (8.2)
---QMS Audit :
via Customer Satisfaction , Internal Audit, Analysis
of Data…等.
--- Processes Audit : via Quality Objectives,
Departmental Goals & Metrics , Internal Audit
Results …等，e.g. SAC Audit 專注於半導體封測之
製程稽核。
--- Product Audit : via IQC, IPQC, FQC, Final
Product Audit (Dock Audit) on product dimensions,
functionality, packaging, labelling…etc
等，e.g. UL之Follow-up Service Inspection Program.
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7.4 Purchasing 採購
•新版ISO 9001：2000沒有了”shall
evaluate and select
subcontractors….including the quality
system….” (新版ISO 9001:2000) Criteria
for selection, evaluation and reevaluation shall be established. (ISO
9001:1994對re-evaluation criteria之規定
很模糊)
298
•新版ISO 9001: 2000沒有了”the supplier shall
review and approve purchasing documents for
adequacy of specified requirements prior to release.” 改
成 ”The organization shall ensure the adequacy of
specified purchase requirements prior to their
communication to the supplier”
•笑話一則: 經濟日報6-13-2001 xx企管報導”ISO
電子化”一文：…許多通過ISO 9000的企業發現，
原本都已電子化的作業，例如訂單，合約都以電子
表單管控，但為應付認證公司定期的ISO稽核作業，
反而要「配合檢查」特別列印出來，造成人力及紙
張的浪費，效率下降。（這恐怕要問問xx企管是那
些Registrars吧？！）
299
•正確做法: ISO/IEC 17025: 1999
4.12.1.4 The Laboratory shall have procedures to protect and
back-up records stored electronically and to prevent
unauthorized access to or amendment of these records.
★Grandfathering (免除適用新的法律/規定)
•資格 (qualification/competency) 認可之另一種 (過渡性) 做法，
通常用於供應商資格 (Vendor qualification) 和人員資格
(qualification/competency of personnel) 兩方面。
•例如公司新建立一個供應商核准程序規定，new vendor在進
入AVL之前要經過survey/D&B (Dun & Bradstreet) financial
rating check (信用狀況調查)，QMS評估…等，然而，對於一
些配合已久，表現良好之pre-existing vendors，還需要重新做
前述之調查，評估…等嗎？
300
•做法：根據以前的歷史，訂定一個臨時之基準
(grandfathering criteria)：
a)
訂定一個時間/日期 (date)
b)
訂定一個資格基準 (criteria)
c)
將上述兩項寫出來 (documented)
d)
展示客觀證據證明pre-existing vendors或preexisting employees 符合上述criteria。
•e.g. 「至6/20/2001為止和本公司往來超過一年之供應商，
其前一年之IQC成績低於3批退貨，其資格予以
grandfathered。」;「於1/1/2001之前任職於本公司，考
績至少在乙等以上之員工，其資格予以
grandfathered。」
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•Do not grandfather documents！ (不可以把文件當成
阿公？) e.g.一些舊的specs，圖面，表單，SOP…等。
因為4.2.3文件管制規定文件必需被“管制” (“審
查”，“核准”…等)。
•價值不大，少用grandfathering！
 Reactive (被動反應) & Proactive (主動/積極) 觀念
Reactive : (8.5.2) Corrective Action (矯正措施)，
(8.3) NCP (nonconforming
product) Control (不良品管制) ，
(8.5.2) Customer Complaint
Handling 等
302
Proactive :
(5.4.1) Quality Objectives (品質目標管理) ，
(8.2.1) Customer Satisfaction (客戶滿意) ，
(8.4) Analysis of Data (資料分析) ，
(8.5.1) Continual Improvement (持續改善) ，
(8.5.3) Preventive Action (預防措施)
Concession/ “used-as-is”/waiver (特採)
--8.2.4 Product release shall not proceed until the
planned arrangements have been satisfactorily
completed, unless otherwise approved by a relevant
authority and, where applicable, by the customer.
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--8.3不良品管制….The organization shall deal with
NCP…by authorizing its use, release or
acceptance
under concession by a
relevant authority and, where
applicable, by
the customer.
FAQ: constituent parts (構成成品之零件) 之
concession需要客戶同意嗎？還是finished product
之concession才需要客戶同意？
答: 看看客戶之contractual requirements是什麼規
定，雖然通常客戶不會要求constituent parts之
concession (acceptance of nonconformity
disposition)需要經過他們同意。(某一家hybrid IC
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廠之案例)。
另外之例子: UL Listed產品之零件變更
需UL同意
如果沒有取得客戶之事先同意/核准，
則對於 service applications 用之產品不
得從事會影響/破壞外觀之rework (QS9000 4.13.3: There shall be no rework
visible on the exterior of the product
supplied for service applications without
prior approval of the customer service
parts organization.)
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 Defect Prevention: e.g. 1). Mistake Proofing (防呆法)
(缺點預防)
2). SPC (統計製程管制)
vs.
3). Visual Controls (視覺控制/顏色
管理)
4). Verification of Job Setups
(作業條件設定驗證/首件確認)
:
(QS-9000 : 4.2/4.9/4.10…等)
Defect Detection: e.g. 1)全檢 2)Random Quality Check
(缺點偵測) 3) 沒有統計基礎之抽檢, 例如 “用規格上
下限做為管制界限” 之“變種” Control Chart
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QS-9000強調Defect Prevention，舉數例如下:
QS-9000 4.2.3.5 Process FMEAsProcess FMEAs shall consider all Special
Characteristics. Efforts shall be taken to
improve the process to achieve defect
prevention rather than defect detection.
QS-9000 4.9.g.1 Preventive Maintenance
The supplier shall identify key process equipment
and provide appropriate resources for
machine/equipment maintenance and develop
an effective planned total preventive
maintenance system.
307
ISO 9001: 1994 4.10.3 In-process Inspection and TestingThe supplier shall:
a) Inspect and test the product as required by the quality
plan (Control Plan) and/or documented procedures;
b) Hold product until the required inspection and tests
have been completed or necessary reports have been
received and verified, except when product is released
under positive-recall procedures (see 4.10.2.3). Release
under positive-recall procedures shall not preclude the
activities outlined in 4.10.3a).
c) (QS-9000) Direct process activities toward defect
prevention methods, such as statistical process control,
mistake proofing, visual controls, (Verification of Job
308
Setups) rather than defect detection.
QS-9000 4.9.4 Verification of Job SetupsJob setups shall be verified whenever a setup
is performed (e.g. initial run of a job,
material changeover, job change, significant
time periods lapsed between runs, etc.).
重點說明: Most likely an AR/Definite OFI if
看不到FMEA上面的“Recommended
Action(s)” 和 Control Plan上面的“Control
Method”有用到Defect Prevention Method(s).
309

QS-9000 之 APQP :
* Bridgestone/Firestone 之事件
* Control Plan 之Control Methods 應該多用上述之
Defect Prevention Methods (所使用之gages 要先
做MSA).
SFMEA
 (drive)
DFMEA
(drive)
PFMEA
(drive)
Control Plan (CP) :
(drive)
Operators Instructions (OI)
System FMEA

Subsystem FMEA

Component FMEA
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(Remarks: 什麼是6標準差？標準差是用來衡量流程品質
的變異或分配狀況，也就是說，控制流程的產出，讓產出
的變異控制在規格界限之內，「流程每百萬次的操作機會，
只允許出現3.4個失誤 (3.4PPM) 」。換算之，3個標準差
的品質水準，相當於1本書平均每頁出現1.5個錯字；6個
標準差的品質水準則相當於1個小型圖書館的所有藏書中，
只容許1個錯字。
「Six Sigma」活動的最終目的，就是經由設計並監控流
程日常操作，將流程操作的可能失誤減少到最低限度。
當企業的操作水平只做到介於3至4個標準差之間時，中間
因為流程操作不當導致浪費、重工、退貨、客訴及檢驗等
因素，不良品質的成本可能佔營業額25%以上。
311
當企業的經營達到Six Sigma的品質水平時，流程的操作錯誤
將接近完美，不良品的成本降至營業額的1%以下，同時能以
最短的循環時間服務顧客，真正做到顧客滿意。
六標準差原本最先在品管界被運用，如今則已成為一種作業精
神，它可以說是一個全面且具彈性的系統，其驅動要素在於洞
悉顧客之所需，嚴格使用事實、資料和統計分析，全力關注於
作業流程的管理、改善與創新。實施六標準差有五大步驟，包
括確認核心流程與關鍵顧客、界定顧客需求、衡量現有績效、
排定改進措施的優先順序並分析執行，以及擴充並整合六標準
差系統。簡而言之，六標準差的精神是透過所謂DMAIC (界
定—衡量—分析—改進—控制的模式加以完成，達到幾乎沒有
誤差的境界。而這其實是一種管理的極致要求，甚至勢必將成
為一種企業文化，怪不得GE奇異的董事長曾說，奇異的共同
語言不是英文，而是六標準差。)
想一想: 6 Sigma vs. BSC vs. Ford’s BOS vs. ISO 9001:2000?
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※Design Loop :
Concept/Feasibility Review (概念形成/可行性評估)
- Design Input
Design Plan
- Preliminary Design Review
(e.g. Gantt Chart)
- Design Verification/Tests
(Design Change)
設計驗証
(On Prototype Sample.
Purpose:check if meeting design input)
(Design Change)
- Design Review
(Design Change)
(CAR, via 連絡單/會議記錄等，
issued if problem occurred, and
re-verified)
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(Design Change)
- Design validation 設計驗收/製程驗証
(On Prelaunch/pilot sample.
Purpose :check if meeting
intended use/requirements for the
specified application e.g.送樣給
UL工程部測試，用以取得UL產
品安規認証。)
-Design Review
(Design Change)
(CAR, via DCR/DCN, issued if
problem occurred, and re-validated)
- Design Output (seeing if meeting
Design Input)
-量產移轉
314
ISO 9000:2000
Verification
Confirmation, through the provision of objective evidence, that
SPECIFIED REQUIREMENTS have been fulfilled
NOTE 1 The term “verified” is used to designate the corresponding
status.
NOTE 2. Confirmation can comprise activities such as
 performing alternative calculations,
 comparing a new design specification with a similar proven
design specification,
 undertaking tests and demonstrations, and
 reviewing documents prior to issue
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ISO 9000:2000
Validation
Confirmation, through the provision of objective evidence,
that the REQUIREMENTS FOR A SPECIFIC
INTENDED USE OR APPLICATION (USER NEEDS)
have been fulfilled
NOTE 1: The term “validated” is used to designate the
corresponding status.
NOTE 2: The use conditions for validation can be real or
simulated.
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Remarks: 通常服務業之產品 ( Service product) 是
將 Design Verification 和 Design Validation 合併一起做!
Design change: Design output released for production之
“前”與“後”都有可 能發生設計變更。量試/量產之
後發生之設計變更，一般用e.g. Customer
complaint(CAR)
(trigger)DCR/DCN (trigger) ECR/ECN.
ISO/TS 16949:2002 7.3.7 NOTE : Design and
development changes include all changes during the
product program life (設計變更含產品生命週期之中之
所有變更)。
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• Design Change (設計變更或 Product Spec Change) / R & D
vs. Engineering Change (工程變更或 Process Spec Change)/
製造工程or PE 。
• 產品規格變更叫「設計變更」
用DCR/DCN; 製程(條
件)規格變更叫「工程變更」
用 ECR/ECN。 如果要“
一單(ECN)兩用”亦可, 但最好在ECN上面分開兩個欄位勾
選( i.e. 產品&製程) , 同時先決條件是此二大 functions 之權
責及流程一定要定義清楚才行! 所以 , 區分清楚較好: 權責
/Traceability
* ISO/TS 16949:2002 7.3 NOTE:「The requirements of
element 7.3 (Design and Development) include product and
manufacturing process design and development，and focus
on error prevention rather than detection (條文7.3「設計與
開發」包含產品及製程之設計與開發，而且專注於錯誤/缺
318
點預防而不是錯誤/缺點偵測)。
7.3.2.2 Manufacturing process design input
The organization shall identify, document and review the
manufacturing process design input requirements,
including
- product design output data,
- targets for productivity, process capability and cost,
- customers requirements, if any, and
- experience from previous developments.
NOTE The manufacturing process design includes the
use of error-proofing methods to a degree appropriate to
the magnitude of the problems and commensurate with
the risks encountered.
319
7.3.3.2 Manufacturing process design output
The manufacturing process design output shall be expressed in
terms that can be verified against manufacturing process design
input requirements and validated. The manufacturing process
design output shall include
- specifications and drawings,
- manufacturing process flow chart/layout,
- manufacturing process FMEAs,
- control plan (see 7.5.1.2.),
- work instructions,
- process approval acceptance criteria,
- data for quality, reliability, maintainability and measurability,
- results of error-proofing activities, as appropriate, and
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- methods of rapid detection and feedback of
product/manufacturing process nonconformities.
7.3.4 Design and development review
NOTE These reviews are normally coordinated with the
design phases and should include manufacturing process
design and development.
7.3.5 Design and development verification
7.3.6 Design and development validation
NOTE The requirements of 7.3.5 and 7.3.6. above apply to
both product and manufacturing processes.
321
7.3.6.3 Product approval process
The organization shall conform to a product
and process approval procedure recognized
by the customer.
NOTE Product approval should be
subsequent to the verification of the
manufacturing process (製程驗證).
This product and manufacturing process
approval procedure shall also be applied to
suppliers.
322
• TC-176對 ISO 9001:2000之訂定, 從
CD1CD2DISFDIS, 就如同對
一件新產品之研發一般, 被 planned
(Design Plan), 被 reviewed (Design
Review), 經過多次對多數users之問
卷調查, 修改(Design Change), 一再
地 verified /validated (Design
verification/validation : user needs),
才告完成.
323
MSA (QS-9000) vs. Calibration :
vs. Precision 精度
e.g. spec.為 10.0 ± 0.1 mm (worst-case)
-Gage之precision (精度/最小刻度): 0.01mm (ideal)
-Gage之 accuracy/bias (準度/器差)
= 1/10 (ideal)
spec. tolerance (規格公差)
(=1/4 min.)
-Accuracy(bias)準度
324
-如果Internal Spec.
< Customer Spec. (工廠
緊縮客戶規格成為內部檢驗規格)，則上
述原則更沒問題
-可依上述1/4(minimum)或1/10(ideal) 原則
來定gage之Acceptance Criteria (允收標準/
器差) depending on importance of
application, cost of gage, cost of repairs etc.
例如，用於量測special characteristics之
gages也許1/10都還是not accurate enough
也說不定！
325
In real world,
CUSL (Customer Upper Spec Limit)
SUSL (Supplier Upper Spec Limit)
UCL
(Upper Control Limit)
CL
(Central Line)
LCL
(Lower Control Limit)
SLSL (Supplier Lower Spec Limit)
CLSL (Customer Lower Spec limit)
Customer Tolerance Band
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-QS-9000 MSA:
Guidelines for acceptance of bias, gage
R & R are:
 under 10% error: Acceptable
 10%~30% error: May be acceptable based on importance
of application, cost of gage/repairs
 over 30%: Not acceptable.
-另外，ISO 10012-1:1992 (Metrological Confirmation System
for Measuring Equipment) Clause 4.3…. The error
attributable to calibration should be as small as possible. In
most areas of measurement, it should be no more than one
third (1/3) and preferably one tenth (1/10) of the permissible
error of the confirmed equipment when in use.
MIL-STD-45662A
The uncertainty of a measurement standard does not exceed
327
25% of the acceptance tolerance of a measurand.
*QS-9000 MSA要求只需做GRR就夠了嗎？
Measuring System Analysis - 4.11.4
Appropriate statistical studies shall be conducted to
analyze the variation present in the results of each
type of measuring and test equipment system. This
requirement shall apply to measurement systems
referenced in the Control Plan (see 4.2.3.7). The
analytical methods and acceptance criteria used
should conform to those in the Measurement
Systems Analysis reference manual (e.g. bias,
linearity, stability, repeatability and reproducibility
studies). Other analytical methods and acceptance
criteria may be used if approved by the customer.
328
PPAP (3rd Edition) I.2.2.10 Measurement System
Analysis Studies
The supplier shall have applicable Measurement
System Analysis studies, e.g. gage R&R, bias,
linearity, stability studies, for all equipment used
for new or modified gages, measurement, and test
equipment.
PPAP (3rd Edition) I.2.2.18 Checking Aids
Measurement system analysis studies, e.g. gage
R&R, accuracy, bias, linearity, stability studies,
shall be conducted in compliance with customer
requirements.
329
APQP 3.9 Measurement Systems Analysis Plan
The Product Quality Planning Team should ensure that a plan to
accomplish the required measurement systems analysis is developed.
This plan should include, at a minimum, the responsibility to ensure
gage linearity, accuracy, repeatability, reproducibility, and
correlation for duplicate gages.
SAC-STD-007 Quality System Checklist 4.11.18 CI * Continuous
improvement is indicated by data demonstrating effective use of
MSA’s to improve measurement system bias, linearity,
discrimination, repeatability, reproducibility, and stability.
笑話一則:
某家廠商在TS認証時 , 除了control plan所 reference的gages有做
GRR(MSA)之外 , 因多做一些control plan 沒有 reference的一些
gages之GRR(MSA)而被開了一個AR…同時課堂上老師的答覆也很
妙…)
330
一般工廠對於gage送校時有二種做法:
a) 直接在發給外校單位之訂單(工單)上面載明
Acceptance criteria, 或
b) 不告訴calibration house (外校單位) 其acceptance
criteria，由cal. house用自己的cal. procedure來執行
校正，等cal. report送回工廠時，由工廠用既定之
acceptance criteria來判定gage是否合格或NG
(常用！)
當NG發生時，對於此gage之disposition不外乎是off-set
(補正)，downgrade(降級使用)，repair(送修)，scrap(報
廢)…等; 同時別忘了，the org. shall assess and record the
validity of the previous measuring results when the equipment
is found not to conform to requirements. (亦即，上一次校正
距這一次校正之間，經由此NG gage所量測結果之有效性
331
需評估及記錄)。
要做到這一點，需注意“(QS-9000 4.11.3) Record of
calibration activity shall include any out of specification
readings as received for calibration.”
此意即指校正記錄需包含任何超出允收標準／器差之讀
值(意即「收」到送校之gage，在未做任何「調整」或
「修理」之前的原始讀值，英文叫“as-received data”，
或叫“as-found data”)。經過「調整」或「修理」之後，
再重新校正之讀值叫“as-left data”。如果cal. record只顯
示出“as-left data”，未列出“as-received data”，則將造
成無法追溯及評估此NG gage先前量測出去之結果之有效
性。
另外，TS 16949:2002要求Records of calibration activity
shall include an assessment of the impact of out-ofspecification condition (校正記錄需包括超出允收標準之
332
情況所造成之影響之評估)。
ISO/IEC 17025:1999 4.10.4.3 也有同樣要求如下:
When an instrument for calibration has been adjusted
or repaired, the calibration results before and after
adjustment or repair, if available, shall be reported.
Remarks: 這也是呼應先前「ISO/IEC 17025 4.12.2.1….
Lab 要保留原始測試/校驗記錄…」之相同 intent.
註: 用前述之as-found data觀念來進一步闡述「公司文
件化之深淺程度或不需要」…
想一想: 有多少公司知道上述重點? What if not
documented in procedure? 靠training 及經驗來傳承
行得通嗎? (Hint: CA-PDCA一下看看…)
333
同時QS-9000 4.11.3更進一步要求“Record of
calibration activity shall include notification to the
customer if suspect material or product may have been
shipped”—意即對前述NG gage先前測量結果之有
效性評估結論為questionable時，則需通知客戶可
能已有一些“懷疑品” (suspect material/product)已
交到他那裡了。(雖是QS-9000規定，但是ISO 9001
適用嗎？當然！)
本人多年前在美國audit時看過“as-received data”
和“as-left data”都同時出現在calibration record上面
(Good example: 利用表單設計之防呆!)。
334
注意“calibration range” (校正範圍) 要能
cover “usage range” (使用範圍)
稽核 process/production path的auditor別忘
了將sample到的gage所量測之spec. (尤其是
worst-case spec.) 及其他相關資料 (e.g. gage
number, location, 校正日，下次校正日期…等)
pass給另一組稽核儀校之auditor用以verify前
述之accuracy & precision.
 “Be safeguarded from adjustments that would
invalidate the measurement result” (e.g. 校正過後
之air screwdriver封上膠帶來防止operator之不當/
不小心之adjustment)
335
當使用computer software來做產品檢測時，其能力需
在使用前被確認 (confirmed)，並視需要而被重確認
(reconfirmed)。 e.g. PCB’s/IC’s之電性測試 (如openshort) 常用golden samples/units→需能test both “good”
& “bad” parts。此時之golden samples就變成了
calibration standards，也需符合ISO 9001:2000
7.6….shall be calibrated or verified at specified intervals,
or prior to use, against standards traceable….;where no
such standards exist, the basis used for calibration or
verification shall be recorded。
 (ISO 9004:2000)工廠應考慮使用「預防製程/過程錯誤」
之方式 (例如:“fool-proofing”防呆法) 來驗證process output
(i.e.產品)，以便降低「量具管制」之需求或花費成本，並
提高對客戶之value。(觀念同先前提過之1:10:100). 336
 ISO 9001只要求到儀器校正就夠了嗎? (e.g.
Lorom之案例)
 以 ISO 9001: 1994 而言, 4.11 之 4.20 即為MSA,
而4.9.之4.20即為SPC
 QS-9000 : Control Plan 內所 reference到之gages
要先做MSA, 才用來做SPC 或 First-Article
Inspection (或 verification of Job Set-up ) 才有意
義.
就如同 ISO 9001 一開始所言明: 工廠要“先”決
定所需要量測之規格 (measurements), 然“後”
再選定有足夠 “accuracy & precision” 之 Gages.
337
FAQ: 執行生產線上之檢驗或量測(on-line QC或IPQC)之
activities需符合QS-9000 4.10.6 及QS-9000 4.11.2.b.1 之
Laboratory Requirements?
Ans: QS-9000沒有要求要做，因為
4.10.6 NOTE: Element 4.10.6 applies to supplier in-house
laboratory facilities, not inspection or testing performed
outside of a laboratory facility.
IASG Interpretation C3: Test Equipment at Work Station (QS9000, cl. 4.11.2) (01/22/99)
Individuals verifying gages at their in process work station do
not have to comply with the requirements for test laboratory
if they are not calibrating equipment at their work station.
If individuals are calibrating equipment, they shall be
338
included in the laboratory organization.
※QS-9000強調的是Big-3 Flavored SPC，而非College Flavored
SPC. (改善手法力求簡單易學，好用！用太多高深難懂手法，反
而可能太“補”，拉肚子！)

“Closed-loop” (“無缺口之環圈”)觀念 :
a) Management Review (管理審查)
b) Design Loop (設計環圈)
c) Internal Audit(內部稽核)
d) CA/PA (矯正/預防措施), External Audit (外部稽
核), Customer Complaints Handling(客戶報怨處理)….
e) Concession (特採) via MRB (Material
Review Board 物料鑑審小組)
f) Quality Policy/Objectives, Customer Satisfaction,
Analysis of Data…等
g) AIT form …
339
*上述任何情況所開列之(Open) Action Items/Action
Plans (“WHO will do WHAT by WHEN”) 都要專人
負責 tracking “ CASE CLOSED” status (有效關案
之情況)  “Closed-loop” 概念!
* “Root-Cause Analysis” / “ Any CAR issued” can
not be closed out until all required corrective actions
have been developed, implemented and effectiveness
verified.
* Need proper justification for any open-looped
situation occurred (e.g. For CAR handling , “No
corrective action required “ is an acceptable
recommendation for corrective action when properly
justified).
340
「Common sense」in auditing “subjective”
requirements:
8大品質管理原則之前3項(I.e. Customer focus,
Leadership & Involvement of people) , 6.3 Infrastructure,
6.4 Work Environment, 7.5.5 Preservation of product….
用一解析度(最小讀值/刻度)為1/2mm(每個最小刻度
1mm還可以再切一半)之捲尺或長鋼尺來量測某一電源
線之規格10±0.1公尺…
 FAQ: 某位具有30年QA背景之美商2nd-party auditor
非常堅持說，MIL-STD-105E表內，碰到箭頭時，只要
採用箭頭下「」第一個或箭頭上「」第一個Ac(允收
數) /Re(拒收數) , 但是樣本數不變 , 這樣對嗎?
341
Ans:不對! 至少有3個理由:
1. 「=採用箭頭下第一個“抽樣計劃”」, 指的是“抽樣
計劃” , meaning 新的「Ac/Re」加新的「樣本數」，not just
「Ac/Re」alone。
2. 「=採用箭頭下第一個抽樣計劃 , 如樣本大小等於或
“超過批量時 , 則用全數檢驗”」, 此即意味著「要採用新的
Ac/Re所對應的“新的”樣本數」，因為除了箭頭朝下「」
之情況外，不可能有樣本大小超過批量之情況(e.g. Lot size為2 ,
採用一般檢驗水準II , AQL 4.0時 , 會形成新的sample size 為3)。
3.MIL-STD-105E本身當然是 statistically valid的。 It won’t
be statistically valid if 沒有採用箭頭下或上相對應之“新的”
樣本數。
……
Knowledge vs. Common Sense vs. 「看電視」?
342
Gap Analysis「差異/間隙分析」觀念
 Gap是指: 三部曲當中之「ISO 9001
requirements」和「company procedures」之
間之gap；「Implementation/practice執行面」
或「Effectiveness執行效果」和「ISO 9001
requirements/procedures」之間之gap。
 通常是透過Process Audit，Internal Audit或
Registrar’s Preassessment Visit (預評)來做gap
analysis。
 “to fill in the gap” through corrective action(s)
taken。
343
新申請ISO 9001認証之公司需多做幾次內部稽核/Gap
Analysis (一次不夠！)，直到gap縮小到最小了，才做
一次完整之Mgmt Review, 才可以向Registrar提出預評
(也是一種 Gap Analysis)/模擬考試)→正評。
所謂的「有些Registrars說: 認証至少要有３個月的記錄」
不是很好之答案。
例外1: TL 9000 Quality System Metrics, 3.4.3. The
supplier shall submit a minimum of three (3) consecutive
months worth of data to the Metrics Administrator and
receive a “Data Confirmation Report” acknowledging
valid submissions to obtain TL 9000 registration
例外2: TS 16949要求至少要12個月之「operational
performance trends」和「內稽&管審之planning &
results」，very tough!
344
笑話一則︰新申請ISO 9001之組織應多做幾次gap
analysis (e.g. internal audit)，直到gap縮小到最少
或不存在，才向Registrar申請認証。千萬不要像報
紙一天到晚都看得到的報導「xx企管公司輔導之xx
餐廳僅以四個月的時間就通過了HACCP和Nxx之
ISO 9002認証….」「xx光電科技公司只花了三個
月即通過了Kxxx之ISO 9002認証….」「xx技術學
院: 中部第一所“零缺點”通過ISO 9002認証之技
術學院…」…。早期的報紙報導更離譜:「Nxx南區
經理給予 xx 新 “零缺點” 的評價…..」「xx公司
僅以3個月時間即通過了ISO 9001/9002認証，而且
是“零缺點”過關….」，難怪聯合報曾經報導: 國
外客戶將台灣的ISO 9000認証評為「最沒品質」！
345
PDCA另解: Please Don’t Change Anything (until root
cause identified, eliminated, and recommended action
tested and effectiveness verified.)
 Root Cause(s) 可能是 4M1E 或 6M1E : Man,
Machine/Tool, Material, Method, Management,
Measurement System, Environment「人, 機, 料, 方法 ,管
理, 量測, 環境」
 Document Change (文件變更)/Design Change或 ECN –
Engineering Change (設計/工程變更)/Process
Change/ECN(製程/工程變更): Need Review & Approval
(需審查/核准), 而且是用來test (trigger) system (e.g.
PPAP) 之最佳方法與時機.
346

Traceability (追溯)觀念 :
Ability to trace the history, application or location of
that which is under consideration
Note : When considering hardware, traceability may
relate to :
- the origin of materials and parts;
- the processing history;
- the distribution and location of the product after
delivery
(1) Calibration – traceable to standards
347
(2) CAR, Customer Complaints, Field
Concerns/Problemstraced back to root
cause : e.g. 有效處理客戶報怨(8.5.2)
透過有效之追溯方法(7.5.3): 例如在Sales負責填
寫之「客訴聯絡單/處理單」上面多加一個欄位
“產品追溯號碼/Serial No.…等”，要求Sales碰
到 任何customer complaint一定要儘力向客戶問出
此Traceability ID/No., 以便接手之QA/QC等人員
能在最短時間內追溯到問題源頭。
Remarks: Customer complaint handling 吃案否
(7.2.3C)？(Why not spend some time checking
through correspondence files of Sales personnel?說不
定會有意外發現!)
348
(3)產品責任( Product Liability) vs. 產品追溯性(Product
Traceability)
Concept: 產品要做到能夠辨識出產品是那一天 ? 在那一個
機器 ? 由誰 ? 使用什麼原料製造 ? 賣給誰 ? 等等，所以在
現今的時代裡，如若某產品出了問題，真正落實ISO的公
司應該是很容易的查知問題何在，或銷售到何處，所以要
回收理論上不是問題，只是有沒有意願做。
(4) Upstreamed sampling 逆向抽樣法以驗收
追溯之有效性(e.g. rubber tire之例子)
服務 (4.19 Servicing) 適用性
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
6.2.2 Competence, Awareness and Training (勝任/教育訓
練) 之重要性 :
(Competence: demonstrated ability to apply knowledge & skills )
The organization shall
a). Determine the necessary competence for personnel
performing work affecting product quality,
b). Provide training or take other actions to satisfy these needs,
c). Evaluate the effectiveness of the actions taken,
d). Ensure that its personnel are aware of the relevance and
importance of their activities and how they contribute to the
achievement of the quality objectives, and
e). Maintain appropriate records of education, training, skills
350
and experience.
•公司要先建立”工作勝任”基準
(established criteria for competence
requirements --- not necessarily documented)。
e.g. Job Descriptions.
•The most common way for an organization
to ensure the ongoing competence of
personnel when products and processes
change is TRAINING. (當「產品/製程變更」
時，「訓練」通常是組織用來確保相關人員
是否持續勝任這些「產品/製程變更」之方
法。)
351
• Training needs can be determined/identified (for new,
existing, transferred as well as temporary/subcontract
employees) from sources such as (對於「新進/現職/轉換部
門/臨時」員工之訓練需求可由下列來源鑑別出來):
--annual assessment that takes into account changes in
technology, annual business objectives and organizational
changes.(年度評估公司之技術及營運目標更新/ 變更 ,
及組織變更)
--CAR’s (e.g. from internal/external audits)
--An employee’s performance appraisal results.(個人考績
結果)
--Customer Complaints.(客戶抱怨)
352
•7.1 Planning of Product Realization….b) the need
to establish processes, documents, and provide
resources specific to the product. (此處之resources
包含Human Resources之
competence/awareness/training)
•常用OJT 「在職訓練」
•Awareness: The training should emphasize the
importance of meeting requirements and the needs
of customer (訓練應強調符合客戶規定及需求之
重要性)。(Auditors will look for evidence: both in
documented form and by interviewing employees).
353
•
Appropriate records of education, training, skills and
experience (適當之「教育/訓練/技術/經驗」之記錄有): e.g.
-signed job application (求職/履歷表)
-Resume/CV (履歷表)
-Signed affidavits (“訓練/資格維持用”宣誓書/具結書)
-Copies of training course and other
certificates (課程DM及上課證明/證書)
-Diploma (文憑)
-Attendance lists from training courses(課程簽到簿)
(如果受訓沒有留下訓練記錄怎麼辦？恐怕要去連絡course
provider或training administrator!)
(1)
“訓練效果” 要被評估
354
•可能的方法有：
---Performance Appraisals表現/績效考核
---Internal Audit Results (interviews with employees)內稽結
果
---Pre- and post-testing 「課前課後問卷/測驗」
--- 課後內部講授
--- 用後心得報告
--- Monitoring of process performance (evaluating the output
of a process to see if the individual is competent)
--- 另找(雇用)能勝任之新人 /「換人做看看」
--- Management Review管理審查
…等。
355
•Positive trends in internal and external
quality measureables also can be an
indication that actions taken have been
effective.
內部/外部品質衡量/ 績效指標之提昇趨勢也
可以代表「所提供之訓練」或「所提供之對
策(actions)」有發揮成效!
356
• 在ISO 9001:2000 upgrade assessment 時，UL要能看到“客
觀證據”來證明為滿足“勝任需求” (competence
requirement) 之訓練 (或other actions taken)效果。包含
“現在”和“過去”所提供之訓練或other actions。(對於
“過去”的，可考慮用grandfathering 方式證明，但不是很
好。)
(1) QS-9000 4.18.1 Training Effectiveness：Training
effectiveness shall be periodically reviewed. (訓練效果要定
期評估 )
(2) It is useful to consider training as a “Just-In-Time” (JIT)
item. Training is most effective when it can be used
immediately (最好將訓練看成JIT: 「現買現賣 , 現學現用 」
最有效! Also, “learning by doing” (從實做中學習) is a
357
powerful paradigm!
(3) 團隊 (team)是最好的教育訓練工具。
(4) Training can replace work/job instructions, but
training can not replace specifications. (訓練可以取代工作
指導書 , 但訓練不可以取代規格 )
(5) TL 9000 4.18.c.2 Quality Improvement Concept.(品質
改善觀念)—Those employees that have a direct impact on
the quality of the product, including management with
executive responsibility, shall be trained in the
fundamental concepts of quality improvement, problem
solving, and customer satisfaction. (對於直接影響產品品
質之員工 , 包括實際參與經營之管理階層 , 均需要訓練他
們瞭解/熟悉「品質改善」,「問題解決」和「客戶滿意」
之基本觀念。)
(6)掃廁所的要competent嗎？Yes (e.g. hotel,
358
restaurant, 公廁..) & No.
Last but not least , 最
後談一談「PDCA循環」當中
之
“P” Segment「規劃/計
劃」!
359
「凡事豫則立 , 不豫則廢」
Clause 5.4.2之 QMS Planning
Clause 7.1之 Planning of
Product Realization
Clause 7.3.1 之 Design and
development planning
QS-9000之APQP
新版 ISO 9001:2000 更強調
PDCA cycle 之P (Plan) Segment
360
“Quality Planning - Part of quality
management focused on setting quality
objectives and specifying necessary
operational processes and related resources to
fulfill quality objectives” (5.4.2)
品質規劃 - 品質管理之一部份 , 但專注於設定
品質目標以及訂定所需實際可行之流程 & 所
需相關資源 , 用以達成品質目標。
361
The Planning Pyramid(規劃金字塔)
High level objectives
Specific objectives based
on the quality policy and
product requirements
Resources and QMS needed
to achieve quality objectives
& 4.1
Quality
policy (5.3)
(品質政策)
Quality objectives
(5.4.1)
(品質目標)
公司/上層目標
由品質政策及產品要求而
展開之部門/特定目標
Quality planning
(5.4.2)
(品質規劃)
為達成品質目標及4.1之要求所需之資源與品質管理系統
362
The Planning Pyramid
Quality policy (high level objective)

“The XYZ company is committed to continual
improvement”

Quality objective (specific objective)

Achieve organizational PPM objective of 60 for the KS
and WP product lines by 12/1/01

Quality planning (resources & QMS)

Purchase mistake proofing fixtures
Revise workmanship standards and procedures
Train personnel in workmanship standards and new
quality system procedures

363
Product Realization (產品實現)

Focus: The need to plan, implement
and control work processes to
satisfy customer requirements

From ISO 9001:1994
The intent of 4.2.3, 4.3, 4.4, 4.6, 4.7, 4.8, 4.9, 4.11,4.12,
4.15 and 4.19 remain, with various streamlining,
additional requirements and reorganization applied
throughout the clauses

364
7.1 Planning of Product Realization
(產品實現之規劃)
From ISO 9001:1994
4.2.3
4.9
4.10
Requirement to plan the processes needed for product
realization, and that this planning be consistent with the
rest of the QMS (i.e., clauses 4, 5, 6, and 8)
(規劃產品實現所須之流程之要求 , 而且此規劃作業要和其
餘之QMS相一致 , 不能相互矛盾。)




365
7.1 Planning of Product Realization
In doing this planning, the following needs to be
determined, as appropriate (做此規劃時 , 需要決定出):

a) Product quality objectives (產品品質目標)
b) The need for processes, documents, and resources
specific to the product (對此特定產品所須之流程 , 文件和資
源)
c) The need for new testing and verification activities (所須
之新的測試及驗證活動)
d) Records to be kept (所需保留之記錄)
Output determined by organization (組織所決定之輸出): e.g.
BOM’s, Process flow chart, PFMEA, Control plan, Operator
Instructions…
Remarks: 類似QS-9000之APQP & Control plan
366
7.1 Planning of Product Realization

What you must see
A process for, and evidence of, planning which addresses
(a)-(d), as appropriate:e.g. APQP/CFT


What you might see
Planning conducted by cross functional quality planning
team (由跨/多功能品質規劃小組來做規劃)
Planning conducted by departmental quality planning
teams (由部門之CFT來做規劃)
New product introduction process (新產品導入流程)
Plans called out from design process (設計流程所產出之計
劃 ) e.g. Design plan




367
7.1 Planning of Product Realization
Typical objective evidence (常見之客觀證據)
Minutes of quality planning meetings (品質規
劃會議記錄)
Quality plans (品質計劃)
Travelers, Procedures, Specifications
Process approval documentation (流程核准文
件) e.g. PPAP records
BOM’s






368
7.1 Planning of Product Realization
Remember: Planning is a living, ongoing
process to ensure changes (e.g.
mergers/acquisitions/org. restructuring ) and
additions to processes are planned (切記: 規劃是
「活的 , 持續的」流程 , 得以確保任何流程都在規劃之
下才得以變更或增加。)
Focus not on the past (i.e., “How did you plan
this process?”), but on the present, (i.e., “How
does the system assure that current and future
changes will be planned?”) 勿專注於過去(i.e. 過去
你如何規劃此流程? ) , 應該要專注於現在 (i.e. 你的系
統如何確保現在及未來之變更都將會被事先規劃?)369

規劃 (Planning)/預防(Prevention)
「規劃: 凡事豫則立，不豫則廢」。「預防: 預防勝
於治療/偵測(Detection)」
 1:7:20 觀念 (Defect in Design/Development :
Production : Field) vs. 1:10:100 觀念
(預防成本Prevention Cost:鑑定成本 Appraisal Cost:
失敗成本 Failure Cost)
 零缺點的精神: 事前預防瑕疵的發生優於事後的檢查
及重工的觀念。
 Error/Mistake Proofing: use of product and
(manufacturing) process design and development
features to prevent manufacture of non-conforming
products.

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狹義之「防錯法 (工具)」 (Error/Mistake-Proofing
Tools/Methodologies, Micro-view):
--Check Sheet/List查檢表
--Verification of Job Set-Up/Set-Up Verification/FirstArticle Inspection首件確認/檢驗 (Do it right the first
time!)
--SPC統計製程管制: 但是，「有S (Statistics)，無PC
(Process Control) 」 → 「 Nice Chart, but No Action 」
→Useless!
(Do it right every time! SPC優於Random Quality
Check/IPQC或沒有統計基礎之巡迴檢驗！品質看得見，
“過程”是關鍵—Process Approach!)

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--Design FMEA (用於設計之「潛在的失效模
式與效應分析」); Process FMEA(用於製程
之「潛在的失效模式與效應分析」) : “前事
不忘, 後事之師”.
-- 「 Dock-to-stock 」 (或稱 「 Ship-toStock 」) Practice進料免檢>Verification at
Supplier’s Premises/Source Inspection源頭
檢驗>IQC進料檢驗(最遜!)
--Preventive Maintenance預防保養
--Visual Control視覺控管 (e.g.顏色管理)
--“Fool-Proof” (Poka-Yoke)防呆法
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--Preventive Action/Loss Prevention預防措施(Sources of
Data可能的資料來源:FMEA, Reliability Prediction可靠
度預測，FTA失效樹分析，Simulation Techniques模擬
技術，市場/客戶資料，各種相關品質記錄，早期預警
裝置/系統:如管制圖…等)
--PPAP生產性零組件合淮程序
--Configuration Management
:
簡言之，亦即“源頭管理”
重點: 一開始在「品質規劃/APQP」階段時 (在“機會之窗
-Window of Opportunity”時)，就應該把前述之「缺點
預防」之工具/方法都規劃/設計進去!
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廣義之「防錯法 (工具)」 (Error/Mistake-Proofing
Tools/Methodologies, Macro-view):
--Standardization標準化/規格化
--APQP先期產品品質規劃/Project Management
--QMS品質管理系統 (e.g. ISO 9001, QS-9000, TL 9000….
等)
--Supply Chain Management (SCM), Customer
Relationship Management (CRM), Enterprise Resources
Planning (ERP).
--ISO 9004, 6-Sigma Breakthrough Methodology,
Organizational Excellence Models (e.g. National Quality
Award Models國家品質獎, Deming Quality Award戴明
獎…..等)

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
QMS之重要性: 80%之問題是QMS不良造成的，只有
20%是產品本身造成的；就如同85%之品質問題是
common cause造成的一般(special cause才佔
15%)→Mgm’t Action & C.I.之重要性
所以，品質不是『檢驗』 ,『製造』出來的；品質是
『設計』 ，『APQP』， 『ISO 9000/QS-9000』,
『ERP』, 『SCM』, 『CRM』, 『6-Sigma』, …. 『規
劃/預防』 出來的。
肯定的是，使用well-trained & highly-qualified auditors
(3rd-party registrar) providing value-added assessment
專業一流之認証機構對於協助廠商達到上述目標是絕對
有正面貢獻的。
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
方針展開(目標管理MBO)/策略規劃(Strategic Planning)與管
理:「運籌於帷幄之中，決勝於千里之外」
Vision/Mission/Value/Strategy/願景/使命/
SWOT
價值/策略

Analysis
Quality Policy/Strategic Objectives/
Measures/Targets (Stretch)
公司目標
(Deployment Process)
Departmental Policy/Goals(Objectives)
(或 Sectional Policy/Goals或 Personal goals)
部門目標

Initiatives/Tactics/ Operational (Action) Plans
(“WHO will do WHAT by WHEN”)
 策略/行動方案
Mgm’t
Project Mgm’t & Results Evaluation
Review
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專案管理 & 結果評估
※ A management review includes consideration of related
subjects at regular management meetings.
5.4.1 Quality Objectives 品質目標
－Something sought, or aimed for ,related to QUALITY
－Shall be (must be) Measurable(因此，一定要
結合到Sec. 8 Measurement，Analysis & Improvement)！
－Should be Challenging, Compromised,
Achievable, Realistic, Meaningful, Result-oriented (not
Activity-oriented)！
－可用和profitability(獲利率)，growth,
funding 等有關之營業目標做為品質目標嗎？
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答：可以有這些營業目標，但不能取代品質目標，(ISO
9000:2000 2.11….The quality objectives complement
other objectives of the organization such as those related to
growth, funding, profitability, the environment and
occupational health and safety. The various parts of an
organization’s mgm’t system might be integrated, together
with the QMS, into a single mgm’t system using common
elements…)，這也同時說明了企業「將各種不同之管理系
統 (management system)，如QMS, EMS, OHS,內控系
統…..等整合成單一之管理系統」是未來必然之趨勢!
－ 品質目標例子: Outgoing PPM, Cycle Time, Lot
Acceptance Rate (LAR), Customer Complaint Response
Time, Operating Equipment Efficiency (OEE), Percent Cpk,
First Pass Success, Yield, Uptime…等(SAC規定)
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-SMART Goals:
Specific
• Uses clear, concise language.
Measurable • Includes ways to measure achievement of the
goal and where to find supporting evidence.
Examples of evidence include documentation,
such as reports, records, and customer opinions
(e.g. through surveys).
Attainable
or
Actionable
• Aims for a realistic accomplishment, with
opportunities for better performance and new
challenges.
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• Goals should be challenging but within the
department’s/individual’s power to achieve.
Relevant
• Relates to the job and to larger goals.
Goals should be directly related to your job, to
your departmental goal(s)/corporate goal(s).
Time Frame • Sets milestone dates and final completion
dates, when appropriate.
註: 別忘了Balancing(制衡/平衡)
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-QS-9000 4.1.4 Business Plan：…Goals and plans
shall cover short-term (1- 2 years) and longer-term
(3 years or more). The goals and plans should be
based on analysis of competitive products and on
benchmarking inside and outside the automotive
industry and the supplier’s commodity…Methods to
track, update and review the plan shall be
documented to ensure that the plan is followed and
communicated throughout the org.
(註: 標竿制度之建立Benchmarking→即向優質企
業或主要競爭對手學習「最佳的作業方式」Best
Practices，以作為績效改進的外在驅動力。)
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- QS-9000 4.1.5 Analysis and use of company level data：
The supplier shall document trends in quality,
operational performance (productivity, efficiency,
effectiveness, cost of poor quality) and current quality
levels for key product and service features. These
should be compared with those of competitors and/or
appropriate benchmarks….
- 過去稽核ISO 9001:1994時，偶而會看到組織只訂定
一個品質目標:「取得ISO 9000認証」，這樣好嗎？
- 常用來訂定目標/策略＆行動方案之方法
SWOT分析:一種透過CFT之brainstorming來做“對
內”（Strengths/Weaknesses）和“對外”
（Opportunities/Threats）之分析而訂定broad
strategies之systematic, structured & disciplined tool.
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Strengths, Weaknesses, Opportunities and Threats
(SWOT) Analysis
Phase I – Brainstorming (腦力激盪)
A SWOT analysis begins by identifying organization’s
internal strengths and weaknesses as related to the subject
marketplace, and the external opportunities and threats that
exist in that marketplace. This process normally takes about
half a day, and should be conducted in comfortable
surroundings without interruptions. It is best accomplished
by a team of no more than 10 people, led by a facilitator who
is politically neutral and skilled in the SWOT analysis
process (such as a corporate business analyst or planner).
The team should include people from the functional areas
affected, who have regular contact with clients and
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competitors.
After explaining the SWOT analysis concept to the
team, the facilitator leads the brainstorming and
records the ideas. If possible, record the ideas directly
into the SWOT matrix (see below) on a lap-top PC
projected onto a screen via LCD projector. If this
equipment is not available, write the ideas on flip
charts, with a separate page for each of the elements.
It helps to have a co-facilitator to divide the work of
leading the session and recording the ideas, although
this can be done simultaneously by one facilitator. The
brainstorming session should cover the elements in the
following order, although some jumping around will
occur as the team starts generating ideas:
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1.Organization’s internal strengths
2.Organization’s internal weaknesses
3.External marketplace opportunities
4.External marketplace threats
When the brainstorming is complete, the team should
review the items and identify priorities*. They should
reach a consensus on the most important opportunities
and threats, in terms of potential impact on future
business.
(How to identify priorities: 可用check sheet， 左欄按順序
列出 Opportunities 和 Threats，上欄列出人名每人3~5票，
投票決定priorities… )
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The brainstorming part of the session
(everything up to this point) can usually be
accomplished in three to four hours, depending
upon the scope of the subject. If the session
schedule allows for a break at this point, it is
helpful to record all ideas electronically in the
SWOT matrix (see below), numbering the
strengths and weaknesses, and lettering the
opportunities and threats.
Then reorder the opportunities and threats to put
the high-priority ones at the top of each list.
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Phase II – Analysis (SWOT交叉分析)
The synthesis of the SWOT elements yields broad strategies
designed to 「leverage 」(使用) organization’s strengths and
「minimize 」(降低) its weaknesses, helping it 「pursue/capture 」
(追求/捕獲) key opportunities and 「counter」(抵抗) the major
threats.
The analysis phase is best conducted with fewer people -- ideally
by one or two business analysts and key members of the team who
are strategic, big-picture thinkers. The process is as follows:
1. Take each opportunity in turn, beginning with the highestpriority opportunities, and identify strengths organization can use
to enhance its ability to take advantage of the opportunity. Write
a brief sentence that explains how organization can 「leverage 」
(使用) the strength to position itself to 「pursue/capture 」(追求/
捕獲) the opportunity.
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SO策略:
利用存在的那些機會，配合公司的優勢，積極創造利基。(通常企業
會做市場區隔與定位的選擇，主要是為了要掌握市場的利基。所謂
市場的利基，指的是『別人不做的，我做 ; 別人沒有的，我有 ; 別
人做不到的，我做得到』; 也就是尋求為客戶創造更多價值的“差
異化”服務。)
2. Take each opportunity in turn and identify weaknesses that
will limit organization’s ability to take advantage of the
opportunity. Write a brief sentence about the impact of the
weakness on organization’s potential to 「pursue/capture 」(追
求/捕獲) the opportunity, or about what organization can do to
「minimize 」(降低) the weakness or its impact.
WO策略:
某些領域中可能有些潛在的機會，把這些領域中的劣勢加以改進，
將潛在機會化為可行的方案，創造價值。
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3. Take each threat in turn, beginning with the highestpriority threats, and identify strengths that organization
can use to 「counteract」(抵抗) the threat. Write a brief
sentence that explains how organization can「leverage 」
(使用) the strength to 「counter」(抵抗) the threat.
ST策略:
利用優勢來對抗威脅。同時，對目前有優勢的領域進行
監控，以便在潛在的威脅可能出現的時候，不會感到不
知所措。
4.Take each threat in turn and identify weaknesses that
will limit organization’s ability to defend itself against the
threat. Write a brief sentence that explains how
organization can 「minimize 」(降低) the weakness, or
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its impact, to 「counter」(抵抗) the threat.
WT策略:
在某些領域內，可能面臨來自競爭者的威脅，或者在變化的環
境中，有一種不利的威脅在這些領域或趨勢中，公司面對這些
威脅存在著一些劣勢，應該把這些劣勢降低或消除掉。
The analysis part of the session may take anywhere from four
hours to a full day, depending upon the scope and complexity of
the subject.
Phase III -- Presentation
Whenever possible, a SWOT analysis should be presented in a
table that shows the complete analysis, ideally on one page as
shown below. This helps readers understand the
interrelationships between the SWOT elements.
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內部分析
外在分析
(抓住) Opportunities
A.xyz program is a big
market, but needs
redefinition; xyz program
testing market is relevant to
our core competencies.(7)***
:
D.Big and growing market in
China (4)**
(利用優勢) Strengths
(降低/改進劣勢&劣勢產生之
影響) Weaknesses
:
6. Broad range of services. :
7. High prices vs. competition
:
:
13. Local service capacity 19. Rigid hiring/HR policies.
:
:
Strength/Opportunity
Positioning(利用這些)
:
:
D13. Leverage local
service capability to serve
Taiwanese manufacturers
in China.
:
Weakness/Opportunity
Implications (改進這些)
A7. Hire people with
appropriate skill level for
lower-level inspection work to
reduce costs without
sacrificing productivity or
quality.
:
Strength/Threat Proaction
: (監控這些)
B6. Target manufacturers
in high-tech industries,
and developing new
technologies; capture
short-term opportunities.
:
Weakness/Threat Reaction
: (消除這些)
G19. Implement effective
reward and incentive
program to improve staff
performance.
:
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:
:
(抵抗) Threats
:
B. Movement of mfg. To China
will shift some xyz and ABC
programs away from Taiwan
(9)***
:
G. Competitors are faster and
cheaper (11)***
Longer SWOTs, however, can be presented in text form, without
a table, on multiple pages. When there is a large number of
strategy statements, it can be helpful to group them according to
the area of activity they pertain to, such as marketing strategies,
operational strategies, and management/organizational strategies.
Because some of the opportunity/weakness implications may not
translate into strategy statements, they can be identified as
“issues” or “assumptions.”
Phase IV -- Application
The analysis statements from the SWOT analysis can become
the basis for marketing and business plans. It is usually helpful
to ask the team to review and comment on the completed SWOT
analysis, for a reality check, before proceeding to incorporate the
strategies and assumptions into a plan.
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※Example of Strategic Planning Process for Mfg Organization (Partial)
Vehicle/Question
Manufacturing Organization
Vision
What is the organization striving to become?
1. ABC Company will become the preferred supplier of
PCB’s to the aerospace industry worldwide.
Strategic Goals
What does the organization intend to achieve?
1. ABC will increase its share of the aerospace market to
65%.
2-4. Etc.
Mission Statement
What does the organization intend to deliver?
Through the provision of innovative solutions, the
highest quality PCB products, superior customer service
and satisfaction and the fielding of a highly competent
workforce, ABC will become the supplier of choice for
customers within the aerospace industry worldwide.
Values, Principles, Policies
How will the organization behave in achieving
its mission?
ABC will build and stake its reputation on its
responsiveness to customers’ needs, production and
delivery of defect-free products, strict adherence to the
highest ethical standards and maintenance of an
unconditional guarantee.
Deployment Process
How will the organization’s personnel know
what direction to take?
The management of ABC will deploy its Vision, Mission,
Values/Principles and Strategic Goals to every
organizational level. Responsible management at each
level will develop functional objectives and action plans
to address each strategic goal for which they have a
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pertinent linkage.
Action Plans/Project Plans
What will the organization’s personnel do to
meet the strategic objectives?
As an example, the action plan for the ISO 9001 Project
within Production, one of ABC’s functional organizations.
Commencing May 2001, Production will:
Form a cross-functional Steering Committee to guide the
ISO 9001 Project.
Appoint the management representative.
Conduct gap analysis of existing QMS (ISO 9001:1994registered) against ISO 9001:2000 and ISO 9004:2000.
Institute project management of ISO 9001 Project,
including return-on-investment (ROI) measurements of
improvements.
Add to or modify quality manual, procedures and work
instructions.
Retrain personnel and implement new and changed
procedures.
Retrain internal auditors.
Have registrar conduct ISO 9001:2000 pre-assessment;
target October 2002.
Implement corrective actions for nonconformances found in
pre-assessment.
Have registrar conduct ISO 9001:2000 registration
assessment; target December 2002.
Project Management & Results Evaluation
How will the organization know how effective
it is in meeting its objectives?
1. ABC’s ISO 9001 Project will be closely monitored and modified as
needed to achieve registration target.
2. Progress will be reported at weekly top management staff meetings.
3. Detailed reports of the progress and ROI results will be reviewed at
the quarterly QMS Review meetings.
4. Present and potential customers will be informed of ABC’s
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successful registration upgrade.
重點 :
A) 作SWOT分析以訂策略時 , 必須充分利用公司的優
勢 , 並且把劣勢減少到最小 , 意味著機會出現時 , 要知
道如何去識別他 ; 當威脅來的時候 , 要知道如何做好準
備。值得一提的是，「當你把優勢運用到競爭對手很
薄弱的領域中時 , 機會就會出現」。因此 , 若要運用到
策略的制定上 , 則光作SWOT分析是不夠的 , 必須以交
叉分析的方式才能將分析的結果運用到策略的制定上。
B) Living document: 對於企業的經營而言，唯一不變
的真理就是變，因此SWOT交叉分析並非做完後就不
變，必須隨著公司的發展及周圍環境的變化，定期修
正，且應該把SWOT交叉分析視為一個連續的過程，
把它作為企業計劃循環的一部份，反覆的加以分析。
395
C) 管理階層要擬定「能發揮競爭優勢( Competitive
Advantage)/核心競爭力(Core Competency)」的策略
(Strategies) , 同時將策略落實到行動方案(Action
Plans/Tactical Plans/Operational Plans)上。訂出策略與行
動方案其實不難，重點在於是否能貫徹做到！亦即: The
ability to execute strategy (strategy implementation) is more
important than the quality of the strategy itself (strategy
formulation)！
D) 制訂量化指標:
直線作戰單位(e.g. clause 7)成果明確，量化指標不成問題 ;
但後勤支援單位(e.g. clauses 4, 5, 6 & 8)許多工作變化大，
難以計量。若那部門、單位或職務，無法訂出「貢獻度量
化指標」，即表示不需要存在，理當裁撤。此論一出，自
然誰也不願被裁，便會爭相貢獻。不過，若直線作戰單位
效率低落、漫無標準，後勤支援單位疲於奔命救火，的確
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難以計量，故宜先改善直線作戰單位。
企業的願景及策略品質固然重要，但是該企業是否
能將策略成功的落實到日常執行的層面才是最重要。
根據調查，只有少於1/10 的策略曾經被成功的實行。
企業過度依賴財務向度的指標將導致無法朝正確的
策略方向發展， 這是因為財務的衡量是一種落後
指標(lagging indicators: financial measures of past
performance)。企業須找 出能創造未來財務成果的
關鍵性「績效驅動因素」(performance drivers)，
譬如: 顧客滿意、創新的高效率流程、新產品/ 服務
之開發，提高資訊系統之可用性，員工專業能力及
士氣 , 供應商績效(e.g.進料免檢…)等，這些相對於
財務成果而言的所謂「領先指標」(leading
indicator:measures of the drivers of future
397
performance)。
換言之，在現今知識經濟時代，如仍僅僅仰賴過去工
業時代所採用之financial measurements (lagging
indicators , e.g.財務報表 focusing on managing 僅佔
一家公司市場價值之10 – 15 %之tangible assets 
short-term outcome/performance)來做為組織之管
理工具是不足且錯誤的。
現今之組織應思考如何有效去開發，量測和管理佔一
家公司市場價值85 – 90 % 之intangible assets
(leading/non-financial indicators/performance
drivers long-term value creation & tangible
customer and financial outcomes, e.g. customer
loyalty, revenue growth & profitability)而產生之
value-creating strategies及其衡量及管理工具
398
( Measure & Manage strategy! e.g. BSC):
a) Build the franchise(經銷優勢)/: the long wave of value creation;
developing new/innovative products & services and customer
segments. Long-term value propositions for targeted customers.
b) Increase customer value/Customer intimacy: expand, deepen, or
refine relationships with existing customers (e.g. cross sell
services, become trusted advisor or consultant, transform
unprofitable customers) through multiple sales cycle. Mid-term
value propositions to targeted customers.
c) Achieve operational excellence: high-quality & responsive
operating processes. The short wave of value creation through
internal productivity management and supply chain
management that enables organizations to provide efficient, zerodefect, and timely production and delivery of existing products
and services to customers. Also the management of asset
utilization and resource capacity. Short-term value propositions
for targeted customers.
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d) Be a good corporate citizen: manage relationships with external,
legitimizing stakeholders, especially in industries subject to
regulation (e.g., utilities, health care, broadcasting,
telecommunications) or safety and environmental risk (e.g.,
petro-chemicals)
e) 強化Employee skills, knowledge, capabilities & motivation;
organizational climate that encourages innovation, team problem
solving and improvement; information technology & databases
that support the employee/workforce and link the organization
to its customers and suppliers
Remarks:「市占率」(market share)是衡量競爭優勢的適當指標?
1. 計算市場占有率的基礎乃是現有的市場需求總量，它是已經發生
的和歷史性的，並不代表未來的需求。換句話說，未來需求有
可能較目前大得多，有待開發 ;但是也有可能趨向萎縮，不管哪
一情況，針對現有之需求設定目標，並不具有實質上之前瞻意
義。
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2. 傳統上，市場占有率乃是建立在區隔市場的統計基礎上，然而今後行
銷所需要滿足的對象，已由區隔化觀念下的「市場」走向「個人化」或
「客製化」的顧客，如要再以市場做為行銷目標，已嫌過於粗糙。另一方
面，今後廠商所努力發展的競爭優勢，越來越重視「差異化」特色，國內
有人稱之為「獨占優勢」，此即謂廠商與廠商之間所針對的客戶對象以及
所提供的產品與服務是無法直接比較的。在這狀況下，計算市場占有率也
是沒有意義的。
F) e.g. 使用「平衡計分卡」來做「策略的衡量」: 企業發展其平衡計分卡
時，無論財務或非財務的目標、量度與指標，都直接來自企業的願景和策
略方向，與其策略的發展和執行合而為一。
 BSC: 用「financial 財務」「customer 顧客」  「internal business
process內部流程」  「learning and growth 學習與成長 (people人、
systems 系統與procedures程序)」四個構面(perspectives)來support組織之
「願景(vision/mission)與策略strategy 」。
平衡計分卡成功的關鍵在於它能以策略為前提整合企業資源，創造綜效
(Synergy)，並重新設計組織的管理系統與建立即時回饋機制，將策略層
層展開為具體的行動計劃，落實成為每位員工的日常工作。經歷10年演進，
如今BSC已發展成全面性的策略管理模式 strategic measurement and
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management system)。
建構策略核心組織/品質管理系統(Strategy-Focused
Organization/QMS之五大基本法則:
1. Translate the Strategy to Operational Terms(將策略轉化為執行
面的語言)
•
Strategy Maps (策略地圖)
•
Balanced Scorecards (平衡計分卡)
2. Allgn the Organization to the Strategy(以策略為核心整合組織資
源)
•
Corporate Role (企業總部角色)
•
Business Unit Synergies (事業單位的綜效)
•
Shared Service Synergies (功能單位的綜效)
•
「Focus聚焦」& 「Alignment整合」: Finite/limited resources,
initiatives, action programs, investments, budget…
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3. Make Strategy Everyone’s Everyday Job (將策略落實為每個人的日常工
作)
• Strategic Awareness (策略認知)
• Personal Scorecards (個人計分卡)
• Balanced Paychecks (激勵性的獎金制度)
4. Make Strategy a Continual Process (讓策略成為持續性的循環流程)
• Link Budgets and Strategies (預算與策略的連結)
• Analytics and Information Systems (分析與資訊系統)
• Strategic Learning (策略學習)
5. Mobilize Change through Executive Leadership (由高階領導帶動變革)
• Mobilization (有效動員)
• Governance Process (統御的流程)
• Strategic Management System (策略管理系統)
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F) CRM能夠讓企業快速的抓住市場的變化 , 滿足顧客的需求 , 獲得持續
領先的競爭優勢 , 如果結合BSC之使用，因CRM而top-down下來的「願
景(Vision) → 策略 (Strategy) → 目標 (Objectives) → 量度 (Measures) →
伸張指標 (Stretch Targets) → 行動方案 (Initiatives)」策略規劃/ 管理會更
「知行合一」)。
G) Timing之掌握非常重要，策略之展開(行動方案之執行)要在「機會之
窗」(Window of Opportunity)內完成。
H) 如何化「危機」(威脅 threats) 為「轉機」(機會opportunities) , 如何將
「威脅」化為「助力」, 在擬定策略時, 也是要慎重思考的!!
I)『管理決定企業盈虧，策略決定企業的存亡』『決策錯誤比貪污更可
怕』；但是, 好的策略 , 也要搭配好的管理 , 才能相得益彰!
J)『守、破、離』三部曲: 「守」即是固守本業 , 走向高附加價值的專業
化; 「破」就是打破傳統，利用創新的手法，建立核心的競爭力。 「離」
是將競爭對手遠遠的拋在後面。
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K) 日本有句諺語:「有願景(策略)而沒有行動力像是做白日夢；有行動力
而沒有願景(策略) 則是場惡夢!」
L) Strategies and technologies only deliver promises. People and processes
deliver results.
M) 要掌握組織自己的核心專長/能力(core competency)，並且不斷的延展
核心專長/能力。
N) Michael Porter describes the foundation of strategy as: the activities in
which an organization elects to excel: “Ultimately, all differences between
companies in cost or price derive from the hundreds of activities required
to create, produce, sell, and deliver their products or services…
Differentiation arises from both the choice of activities and how they are
per-formed.” The essence of strategy is choosing to perform activities
differently from competitors so as to provide a unique value proposition. A
sustainable strategic position comes from a system of activities, each of
which reinforces the others.
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N) Strategy describes a differentiated value proposition (差異
化價值主張)
1. Product leadership (產品優勢)
2. Operational excellence (作業優勢)
3. Customer intimacy (顧客關係)
O)「核心能力」不及「競爭優勢」(Competitive advantages):
你的「核心能力」(Core competencies)是什麼 ? 你的「競爭
優勢(Competitive advantages) /策略」是「成本領先」，
「差異化」或「專業化」?
「開源」&「節流」: 卓越的企業不以「低成本」(節流: cost
reduction , downsizing等) 為唯一的策略， 「差異化」/ 「專
業化」/ 「市場區隔」(by focusing on niches)(開源) 將成為趨
勢!!(通常之Financial strategy: Growth & Productivity)
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P) 「If you can’t measure it, you can’t manage it 」. Jack Welch of GE:
「What you measure is what you get - what you reward is what you
get.」! But difficulty in measuring the conversion of inputs to outputs in
some critical support processes like R & D should not prevent
organizations from specifying objectives and measures for such processes.
Companies should not fall into the trap of “ if you can’t measure what
you want, want what you can measure.”
Q) Michael Porter: “Strategy is not only what the organization intends to
do, but also what it decides not to do.” (策略非僅決定組織要做什麼，並
且也同時決定了不做什麼。)
R) 先找對人，再決定要做什麼(策略):
企業界有句老生常談:「員工是你最重要的資產。這句話其實說 的不對，
員工不是你最重要的資產，適合的人才，才是你最重要的資產( i.e. right
person for the right job!」
S) 強調紀律的文化:
當員工有紀律的時候，就不需要層層管轄；當思考有紀律的時候，就不
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需要官僚制度的約束 ; 當行動有紀律的時候，就不需要過多的掌控。
Business Operating System (BOS)
The Business Operating System is a disciplined system used to promote
and manage continuous improvement by assembling and analyzing data
for the Key Measurables (KPI’s). The system allows a team to quickly
review and act upon its findings.
Overview
Key Measurables (KPI’s)
Tools
• The Trend & Goal Chart
• The Pareto Chart
• The Problem-Solving Process
• The Paynter Chart Review System
Review System
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Deployment System
How to prepare for the BOS
Conduct a Situation Analysis (e.g. SWOT Analysis)
Review the Corporate Vision
Establish the Strategic Plan
Implement the BOS
How to implement the BOS
Educate Senior Management
Select the Key Measurables (KPI’s)
Establish the Measurement Plan
Review and Consolidate Trend & Goal Charts
Create the BOS Manual
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Schedule Regular Reviews
Set Performance Goals
Review and Analyze Performance Data
Plan for Problem-Solving
Internally Assess the BOS
Conduct a BOS Assessment
Estimated Timing for BOS Implementation –
Gantt Chart
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不要為ISO而ISO: 品質是一種態度，一種由上而
下的企業文化，沒有來自Top mgmt之承諾與堅持
，沒有將品質的理念內化為組織每個人的思維與行
為模式中，成為組織文化的一部份，那麼組織拿到
ISO認証又代表了什麼? (這種ISO系統就像:「有
ISO的骨架(framework)，卻沒有ISO的靈魂!」)
 ISO 9001 : 2000 之推動絕不止是「標準化」而已
, 而是 C.I. C.S.Strive to Exceed Customer
Expectations. (i.e. Customer Delight顧客喜悅)
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三管其下
: (1) Management involvement/support
(2) Good consultant
(3) Professional /thorough 3rd-party audit :
like UL
ISO
9000/QS-9000輔導顧問=QMS設計師與訓練師。
What if 貴公司用了二流或三流之顧問師呢？沒關係，
找一家一流之Registrar來做認証，則貴公司之QMS還
有機會做「設計變更」。否則，未來3~5年貴公司之
QMS就這樣一路「爛」到底。
一開始推動ISO 9000/QS-9000之前就向輔導顧問指
名要UL認証之side benefit: 你可能想不到，他一定會
更加倍賣力輔導！Why?
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Management
involvement/support之重要性
--Clause 5 of ISO 9001: 2000 & ISO 9004: 2000
--QS-9000 APQP 4大階段 (i.e. Planning, Product
Design & Development, Process Design &
Development和Product & Process Validation), 每完
成一階段，都要求Management Support。
--QS-9000 4.1.2.5 Information to management
Management with responsibility and authority for
corrective action shall be promptly informed of
products or processes which become noncompliant
with specified requirements.
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笑話一則: 台灣 ISO 9000/ISO 14000/QS-9000
等認證/輔導之奇特現象 :
(1) 某些Registrar, 早上 09:00開始 opening meeting, 下午
3:30 一定結束 audit 走人(有些中午出去吃飯, 吃到 2:00
~2:30 PM), 一天稽核時間嚴重不足 8 小時 ( QS-9000,
App. H : The number of hours per day required for an
“auditor day” shall be defined as not less than 8 hours of a
24-hour day per auditor on-site performing the audit)
(2) 同樣的, 這些Registrars 沒有看「夜班」(Graveyard
shift), 但 audit report 卻寫著有看夜班( QS-9000, App H :
Each audit shall include auditing on all shifts.)
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(3) 現在流行 “ 初評/正評很認真做, 以後年度追查
就 “青青菜菜”, 現場繞一下, 開個缺點或沒缺點,
意思一下就好 ! (最糟糕的是還跟你聊天聊個沒完)”
(4) 一張證書賣20萬元(See 經濟日報 90年1月15日 副
刊報導).
(5) 對條文要求之解讀太離譜(e.g. 4.4 Design Control
需 “創新發明”; 4.17 Internal Audit 不可以
Subcontract 出去 ; 服務業, 如補習班之認證 ------ 4.11
Calibration 是指老師之 retraining…..等)
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(6) 對認證結果之判定太離譜(e.g. 客供品管制無
procedurally addressed ------ Major Nonconformity ;
沒有正本管制 Mil-STD- 105D Major
Nonconformity；某個部門被發現用了兩本noncontrolled copies的三階文件→Major
Nonconformity…)
某一工廠之Torque driver 送至OEM校驗判定合格，
但送回工廠時，雖然不符合內部規定之Acceptance
Criteria，仍然不小心被判為合格 ------ Major
Nonconformity
某一工廠仰賴 fax 接收顧客訂單，但正評時，因傳真
機壞掉，被判Major Nonconformity!
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浮爛鬆散之ISO 9000/QS-9000認証至少有兩
點不良影響:
I. Operators想: 「原來認証是這麼回事，
隨便應付就可以了，何必做那麼好！」
II. 「有樣學樣」，internal auditors (4.17)
學到「壞榜樣」(「壞習慣」加「專開
一些沒有營養之缺點」)！
當然，最不好的影響是QMS推動成效不彰
，意即競爭力逐漸衰退了！
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優質/高檔的ISO 9000/QS-9000認証至少有
兩點良性影響
•面子: 証書公信力強, Sales拿給客戶看, 對爭取客戶訂單有助益！
(客戶會覺得能拿到UL之ISO 9000/QS-9000証書, QMS絕對有一定
之水準, 對下訂單給他們所承受之 採購風險會相對降低)。說不
定還能享受客戶之「免除audit」或「降低audit frequency/depth」。
•裡子: 「嚴謹」 「認真」 「專業」的稽核所帶來的QMS之持
續改善，績效及競爭力之提昇！
•QMS一定要和平時日常運作結合（e.g.新廠/設備要comply with
QS-9000,4.2.6之Facilities & Tooling Management, 要用APQP
concept…）, 千萬不要有「create 假資料/記錄」「QMS的推動
是QA的責任」「ISO 9000/QS-9000是負擔/包袱，以前沒有它，
公司的運作還更有效順暢」…。
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「唯一不變的真理就是『變』！ 」，時代在變，科
技日新月異，QMS也要跟著變與調整！它是「活」的，
就如同FMEA/Control Plan是“living documents”一般！
「人」可以說是QMS (Resources) 組成要素當中最重
要的一項，個人及組織之加速創新、追求速度與品質、
發揮終身學習 (Lifelong Learning) 精神與知識分享、
掌握網路化經營趨勢、有效取得與運用智慧資產等課
題。這些都是現今「學習型組織」(Learning
Organization) ，「知識管理」(Knowledge
Management) 及「知識創新」(Knowledge Innovation)
所強調的，因為Knowledge is Power。
要訣: “Learning by doing”(從實做中學習) is a
powerful paradigm.
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同時，學習改變/思維模式的改變(e.g. Paradigm
Shift / 6 Sigma /Change Management) ，才能突破
成長極限，因為個人及企業最可怕的敵人就是「習
慣的老想法」。身為Auditor是否足夠
Knowledgeable，恐怕更形重要了！有一句話說:
“You never get a second chance to make a first
impression.”(永遠只有一次機會給客戶「最佳的第
一印象」，希望所有UL auditor在每一次新的出擊，
都能讓人耳目一新，印象深刻！
想一想: 你個人「被利用的價值」是什麼? 你是公
司的「資產」或「負債」? 同時 , Among「知識」，
「行動」及「危機意識」之個人成功三要素之中，
你欠缺了那一項？
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