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

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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至整個組織內。 )

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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….”」

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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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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)

Structure changes

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Features of ISO 9001:2000Features of ISO 9001:2000Most 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 PDCAComparison (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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新版新版 ISO 9001:2000 ISO 9001:2000 稽核方式稽核方式 ((AssessmentAssessmentPhilosophy) Philosophy) 有那些變更有那些變更 ??

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 (sub-

clause 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 enhancing customer satisfaction.

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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 long- and short-term quality planning.

• QS-9000 APQP各階段之收尾所要求的“Mgmt Support”.

• QMS 之推動絕非只是 QA 之責任

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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 & linkagescreate “synergy(綜效 )” & integration( 整合 )– the whole exceeds the sum of the parts. 打破functional & departmental barriers/silos/boundaries (via communication..): 「打破藩籬 ( 內牆及外牆 ) 」 ! 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 !)

e.g. Piles and piles of records gathered but sit there to collect dust….。

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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 systematic approach to management.)。

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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 applicable regulatory reqmts.

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-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

(Physical, sensory, behavioural,Temporal, ergonomic, functional)

Need or expectation that is stated, generally implied or obligatory.

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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) 。

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-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 )

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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」

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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.

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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。

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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。

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FAQ: 本公司並沒有設計開發部門 (R&D) , 而且多年來一直都是生產非常成熟之 UL線種 SPT-1 和 SPT-2(根據UL 62電線標準 ) , 此情況是否可將 ISO 9001:2000 之 7.3( 設計和開發 ) 排外 ? If not, 在未來幾年 , 我們也可能無任何新設計案 !?

Ans: 1. 問題不在有無 R&D 部門之設立 , 想一想 product “characteristics”(distinguishing features)/product specs (design output) 是誰訂的 ? UL62 電線標準只告訴你一些 safety requirements (design input) , 它並沒有告訴你其他 non-safety requirements(e.g. 顏色、外觀、花紋… )! 如果組織必需根據客戶 /UL安規要求 (customer/UL safety requirements:design input) 來定義 (define) 這些線種之產品特性 /規格 (product characteristics/specs:design outpout) ，或稱「開規格」，則該組織是有從事 7.3 「 ( 產品 ) 設計與開發」 !

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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 !

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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!

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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」。

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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.

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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為一個 “流程”「 process」 )

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• 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」。

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• 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」。

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When used within a QMS, such an approach emphasizes the importance of

a) Understanding and fulfilling the requirements,

b) The need to consider processes in terms of added value,

c) Obtaining results of process performance and effectiveness, and

d) 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 :

a) 瞭解及滿足 (符合 )規定 ,

b) 需要以是否能提高附加價值來思考流程 ,

c) 取得流程績效 / 表現及效果之結果 , 和d) 依據客觀量測而進行之流程之持續改善。

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PROCESSPROCESS(“Set of interrelated (“Set of interrelated or interacting or interacting activities”)activities”)

INPUTINPUT OUTPUTOUTPUT

MONITORING AND MONITORING AND MEASUREMENT MEASUREMENT

OPPORTUNITIESOPPORTUNITIES

(Before, during and after the (Before, during and after the process)process)

PRODUCT PRODUCT (“Result of a

process”)

PROCEDUREPROCEDURE

(“Specified way to carry out an activity or a process” – may be documented or not)

EFFECTIVENESS OF PROCESS = ABILITY TO ACHIEVE DESIRED RESULTS (Focus of ISO 9001:2000)

EFFICIENCY OF PROCESS=Results acieved vs resources used (Focus of ISO 9004:2000)

(Includes Resources)

Focus of TS-2: Effectiveness+Efficiency

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PDCA/PDSA (Plan-Do-Check-Act 或 Plan-Do-Study-Act: 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!)

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Act●How to improve

Next time?

Plan●What to do ? ●(“Objective”)

●How to do it? ●(“Procedure/method”)

Check●Did things happen according to plan?

Do ●Do what was planned

“The objective w/o method is useless”

Better (Q)

Cheaper (C)

Faster (D)

“Monitor and measure processes and product against policies, objective and requirements for the product and report the results.

Check:

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PDCA vs. Process Approach/Interaction

A

C

P

D

EXTERNAL

CUSTOMER

EXTERNAL

CUSTOMER

PA

DC

PROCESS A

PROCESS B

PA

DC

PA

DC

PROCESS C

PA

DC

PROCESS E

PA

DC

PROCESS D

PA

DC

PROCESS FInternal

CustomerInternal

CustomerFeedback

Output D

Output EInput A

Input B

Output A

Output B

Input C

Input F

Output F

Output C

Input D

Input E

New process: 從 PDCA的 P開始轉Existing process: 從 PDCA的 C開始轉

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PROCESS CONTROL SYSTEM MODEL

WITH FEEDBACK

THE WAY WE WORK/ BLENDING OF RESOURCES

STATISTICAL METHODS

VOICE OF THE PROCESS

MEN

MACHINES

MATERIALS

METHODS

ENVIRONMENT

VOICE OF CUSTOMERS

CUSTOMERS

IDENTIFYING CHANGING NEEDS AND EXPECTATIONS

INPUTS

PROCESS/SYSTEM

OUTPUTS

PRODUCTS OR SERVICES

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Process Approach Model

PROCESSPRODUCT REALIZATION

RESOURCE MANAGEMENT

C

U

S

T

O

M

E

R

C

U

S

T

O

M

E

R

MANAGEMENT RESPONSIBILITY

Measurement,Analysis,improvement

Satisfaction

Product

OutputInput

Requirement

Continual Improvement of the QualityManagement System

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8. Measurement, Analysis

and Improvement Processes

Examples:

•Processes to demonstrate:

•Conformity of product

•Conformity of

management system

•Continual improvement

5. TOP Management Processes

Examples:

•Process to define quality policy and objectives

•Communication process

•Management review

6. Resource Management Processes

Examples:

•Determination and provision of resources

•Human resources

•Infrastructure definition

•Work environment definition

7. Product Realization Processes

Examples: • Planning

•Customer related processes

•Design & development process

•Purchasing process

•Production & service provision

•Control of monitoring and measuring devices

(Fig 1)

4.1 Quality Management System Processes

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Correct

Identify Core Processes (COP’s)

Needs & Expectations

Improve?

Process Design Product Design

A

NO

D

YES

Customers

OK?C

Check Results

P

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• 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 ) 。

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• 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 ) 。

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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!」

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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 ) 。

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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 )

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-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”

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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

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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

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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「從顧客需要著手」，而非企業的需要。

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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 .)

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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　

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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」。

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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

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•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 :

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採購下單程序 (Procedure 12)

Procedure owner: 採購經理

Routine requirements generated from system to

採購員

收到「採購需求」

(Form PR 001)

採購員

採購經理核准「採購需求」

(authorized signatory list: Form AS 001) 採購員

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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

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Order correct

Request returned to originator System processing completed採購員

Suspect order discrepancy

Purchase order produced (Form PO001)

採購員

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Copy to supplier

採購員

Copy to file採購員Copy to

accountants

採購員

Copy to Incoming Material Receiver ( 接到下一實例 :「 How to audit IQC? 」也是 process interaction with IQC)

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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。

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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IQC Procedure/SOP/SIP, 或邊讀邊問… )

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-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)

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- 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)?

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-「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 process ( 工作 / 作業流程 ) 」 (A) ?

81

-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)….。

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- 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 !

83

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。

84

-「 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 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.

trigger

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-- 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 …」。

trigger

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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 the quality management system.

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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.

88

-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 user-friendly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 :

89

附件一：總經理室管理課生技課業務部資材生產品管客户

OK

NG

/全檢特採

NG

OK NG 反箱/重工

OK

NG

/反箱重工特采 NG

OK

特採

工程 ?品質系流程圖

先期產品品質規劃 2-1訂單審

3-2查物料申購4-1 5-1來料檢驗

擬訂生產計劃 3-3 ?經理以上人

? 10-1員裁

退回廠商 9—1 5-2過程檢驗

成品檢驗 5-3

2-作業變更 2

5-4出貨檢驗出貨 9-2

客户供4-2應品

客户抱怨處理14—2

客户抱怨接收14—1

经理级以上人員裁决10-2

製造 6-1

管理責 1任

持續改善 14—3

訂單接收 3-1

内部稽核 13—1

資源管理11—1

文件與資料管制及記錄 12—1

客户满意 14—4

產品標識與追溯及檢驗與測試狀態 8—1

儀器校驗7—1

統計 15-1

設備維護 6-2

品質手冊之「 Process sequence/interaction 之描述」之實例 :

90

　　附件二

QS 條文及

系統過程名稱流程名稱流程编號 ISO9001 94版條文

管理審查過程管理審查 1 XXP0101 總經理室4.1+4.2.1+4.2.2+5.1+5.2+5.3+5.4+5.5+ 5.6

4.1.1+4.1.2+4.1.3+4.1.4+4.1.5

541C1+542C1+553C1+

衡量指標

先期產品品質規劃 2—1

作業變更 2—2

訂單接收 3—1 XXP0301 業務訂單審查 3—2 XXP0301 資材/工程擬定生產計劃 3—3 XXP0301 資材物料申購 4—1 XXP0601 資材客户供應品 4—2 XXP0701 資材/客户進料檢驗 5—1

過程檢驗 5—2

成品檢驗 5—3

出貨檢驗 5—4

製造 6—1 XXP0901 製造 4.9 71C3+755C1

設備維護 6—2 XXP0902XXP0903 生技

4.2.6

檢驗量測與測試校驗過程儀器校驗 7—1 XXP1101 品管7.6 4.11 76H1

XXP0801 生產 7.5.3 4.8 71HS1+753H1+731C2

XXP1201 品管 4.12

XXP1001XXS1001

755HS1+823C1+824HV1+824HV2+824H1+824H2+824H3品管

過程、程序ISO/QS/TL關聯圖

71C1+71C2+71C4+731C1+731C3+732C1+732H1+732C2+732C1+737C1+737C2+737H1+737HS1+752HV1+ 753H2 +542C3

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

XXP0401XXP0402XXS0401

工程

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

頁次：1 OF 2

?文件號：XXQ0001

TL條文ISO9001

2000年條文

產品標識與追溯及檢驗與測試狀態

系統過程

設計與研發過程

? 子有限公司

產品標識與追溯性及檢驗測試狀態過程

檢驗過程

741C1原物料採購過程

生產製造過程

4.10.1+4.10.2+4.10.3+4.10.4+4.10.5+4.10.6+4.10.7

7.4.3+8.2.3+8.2.4

合约審查過程

7.5.1a+7.5.1b+7.5.1c+7.5.1d+7.5.1e+7.5.2

文件编号

4.3.1+4.3.2+4.3.3+4.3.4+Sec. II

責任單位

4.2.4.2+4.6.1+4.6.2+4.6.3+ 4.7

7.2.1+7.2.2+7.2.3

7.4.1+7.4.2+7.5.4

8—1

91

附件二QS 條文及

系统過程名稱流程名稱流程编號 ISO9001 94版條文

退回廠商 9—1 資材

出貨 9—2 資材

不合格品管制過程經理级以上人員裁决

10—110—2 XXP1301 品管

8.3 4.13.1+4.13.2+4.13.3+4.13.4

723C1+723H1+824H4

資源管理過程資源管理 11—1XXP1801 管理課

6.1+6.2.1+6.2.2+6.3+6.4

4.18 622C1+622C2+622C3+622C4+622C5+622C6+622HV1+ 64C1

文件資料管制及記錄過程

文件與資料管制及記錄

12—1

XXP0501 所有部門

4.2.3+4.2.4 4.5.1+4.5.2+4.5.3+4.16

423C1

内部稽核過程内部稽核 13—1 XXP1701 所有部門 8.1+8.2.2 4.17

客户抱怨接收 14—1 業務

客户抱怨處理 14—2 品管

持續改善過程 14—3 所有部門 4.2.5+4.13.2.1

客户導向 14—4

XXP1901 業務

8.2.1 4.1.6+4.19 52C1+52C2+542C2+751C1+751C2+751HS1+751HS2+ 821C1

統計技術過程統計 15—1 XXP2001 /品管資材 8.4 4. 20 84H1

XXP1401XXP1402

TL條文

723C2+723C3+723C4+84C1+851C1+851C2

頁次：2 OF 2

8.5.1+8.5.2+8.5.3

責任單位

755H1

矯正預防/持續改善過程

產品搬運，包装，貯存交貨過程

? 子有限公司過程、程序ISO/QS/TL關聯圖

4.14.1+4.14.1.1+4.14.2+4.14.2.1+4.14.2.2+4.14.3

4.15

?文件號：XXQ0001

7.5.5+7.5.1f

系统過程文件编號

XXP1501XXP1502XXP1503XXP1504XXP1505XXP1506

ISO90012000年條文

92

Tentative Agenda

Date Time Path 1 Path 2 Path 3

9/24/01 09:00 Opening Meeting 稽核前會議

09:20 Plant Tour 工廠巡視

09:40 設計與研發過程原物料採購過程生產製造過程

12:00 Lunch 　午餐

13:00 --Continue-- 產品搬運，包装，貯存 , 交貨過程

--Continue--

17:30 Daily Briefing 　當日報告

Process-based agenda 實例 :

93

09/25/01 09:00 合約審查過程檢驗過程 --Continue--

12:00 Lunch 　午餐

13:00 不合格品管制過程 --Continue-- --Continue--


19:40-21:00

生產製造過程( Night Shift)

09/26/01 09:00 矯正預防 / 持續改善過程

檢驗量測與測試校驗過程内部稽核過程

13:00 --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


94

09/26/01 09:00 --Continue-- --Continue-- --Continue--

12:00 Lunch 　午餐　

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--


95

「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.

96

–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。

97

– 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？ )

98

–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 !

99

* 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 ) 」

100

*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 )

101

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 communication).

102

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

103

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！ )

104

• 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 ),

105

-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 ?

106

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 !)

107

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) 。

108

Automotive Value-Added Assessment vs. CSPM-driven 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.

109

“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;

110

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 non-conformance;

The CSPM and revised audit trail are documented;

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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.

TS-2 Rule:

The organization shall provide the following documentation to the CB for review, and for use in planning the audit:

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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 features.

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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.

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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.

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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.

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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.

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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

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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

(management review)…。

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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,

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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.

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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.

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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.

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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.

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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 !

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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 ?

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(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。

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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.

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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

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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。

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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

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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 )

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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」。

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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

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•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全部委外… )

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(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 identified COP.

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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

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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

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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”。

139

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。

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－ 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。

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Process oriented auditingProcess oriented auditing

IATF expects TS-2 auditors to audit Customer Owned IATF expects TS-2 auditors to audit Customer Owned Processes (COPProcesses (COP ，，也有人稱為也有人稱為 Customer Oriented Customer Oriented Processes Processes 或或 Core Processes). The COP is a model that Core Processes). The COP is a model that was introduced by ISO 9001:2000 and refers to the fact was introduced by ISO 9001:2000 and refers to the fact that any organization needs customer input to comply to that any organization needs customer input to comply to specified and expected needs of the customer (output). This specified and expected needs of the customer (output). This is accomplished by value adding processes of product is accomplished by value adding processes of product realization and appropriate support processes, both realization and appropriate support processes, both enabled by management activities and provided resources. enabled by management activities and provided resources.

The audit approach of TS-2 must not be driven by an The audit approach of TS-2 must not be driven by an “element” or a “section” driven checklist. Instead the “element” or a “section” driven checklist. Instead the checklist shall be a tool to identify the completeness of checklist shall be a tool to identify the completeness of the audit, which means that the auditor shall audit all the audit, which means that the auditor shall audit all applicable requirements to an identified COP.applicable requirements to an identified COP.

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Automotive Value-Added Assessment vs. CSPM-driven 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.

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“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;

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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;

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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.

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•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”

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GlossaryCorrection (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.

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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.

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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 )

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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.

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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.

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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.) 。

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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 ):

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條文說明

Immediate/Interim/Remedial

Action(s) e.g. rework/repair,

regarde/downgrade,

containment, scrap/reject,

concession, G8D之 D3

(Develop the Interim

Containment Action) ,

「治標」 e.g. 打「退燒針」 , 頭痛

(只是 syndrome): 吃「普拿

疼」 , 但 root-cause 可能

是腦瘤……

C8.3

(8.2.2& 8.2.3)

QS-9000 4.9.2 & TS 16949 8.2.3.1之Reaction Plan in Control Plan

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CA 8.5.2,

PA 8.5.3

8.4

QS-9000 4.9.2 & TS 16949 8.2.3.1之 CA Plan 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

Root-Cause(s) elimination , 「治

本」 i.e. 對症下「對」葯，把病因

( 腦瘤 )徹底根除 !…

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Kaizen (Kai 「改」 means change and Zen 「善」 means good): continual improvement of all areas of a company, not just quality.

Is there a way that is Better (Q), Cheaper (C) & Faster (D)?

8.5.1

不僅僅是「客戶抱怨處理」和

GS (Good Service): 「好的服務」而已 !!8.2.1

CI/

Innovation

CS

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ISO 9004,

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」

CD

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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)?

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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QS-9000 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 ) 」。

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舉例如下 :

Acceptance Spec.

•Surface should be free from flaws.

( 表面不可以有瑕疵 .)

•Surface should conform to master standard in color, texture, brightness and imperfection.

( 表面必須符合顏色 /光澤比對標準 )

Comment

•What is a flaw?

-Do inspectors agree?

-How measured?

Conform to what degree?

•How measured?

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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 ( 執行外觀比對人員之資格証明 )

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-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 ) 」。

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- 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」

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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」

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-- 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?!)

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--- 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 ?

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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.

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--- 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」…。

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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 :

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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

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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 causes producing 80% of a problem」

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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

過程如下 :

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“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)

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UNITS, HOURS OR DOLLARS

0

20

40

60

80

100

EFFECTS CATEGORIES

(圖 1)

Pareto Analysis of Effects

(圖 2)

Cause-and- Effect Diagram

A B C D E

EFFECT “A”

METHODS MANPOWERPOSSIBLE CAUSES OF EFFECT “A”

MATERIALS MACHINES

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0

100

200

300

400

500

600

CAUSES CATEGORIES

圖 3

Pareto Analysis of Causes

100

85

69

46

「 the 20/80 rule of thumb( 經驗法則 )…20% of the causes producing 80% of a problem」

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0

20

40

60

EFFECTS CATEGORIES

0

20

40

60

EFFECTS CATEGORIES

DIFFERENCE BETWEEN TWO TIME PERIODS



BEFORE CHANGEBEFORE CHANGE

圖 4

Before-and-After Measurement

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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」。

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--( 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」 3. 也可以將上述二原則合併採用。

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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 SOP( 標準作業流程 ) ，毫無彈性可言。

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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，如火辣辣的巴掌打到顧客臉上 (服務業 ) 。

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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.

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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.

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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… ) 。

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-- 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.

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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 documented.

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--( 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.

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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.

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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 below illustrate the Paynter Chart.

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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.

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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.

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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.

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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, and Process Sheets.

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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?

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QS-9000 4.17.1 When internal/external nonconformances or customer complaints occur, the planned audit frequency should be increased.

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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 Actions

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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

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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)

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--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)

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--- 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.

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--- 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)

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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.」

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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 !

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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.

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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 !

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--- Reliability Prediction ( 可靠度預測 ) 之使用

--- Processes that provide early warning of approaching out-of-control 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).

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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.

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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 proficiency-testing results.

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範例 :

CORRECTIVE ACTION PREVENTIVE ACTION ( 再發防止 ) (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

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CORRECTIVE ACTION

--Reactive ( 被動反應 )

--Single Occurrence (單一事件 )

(existing nonconformity/out -of-

-specification occurrence)

--Action is required usually

( 通常需要對策 )

PREVENTIVE ACTION

--Proactive (主動積極 )

--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

--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 )

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CORRECTIVE ACTION PREVENTIVE ACTION

-- 個案 CAR/G8D 之有效處理 -- CAR 處理之延伸 :

&結案 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 )

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-- 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)…。

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Same idea like SPC

UCL

CL

LCL

trend

(Real-time action taken)

(Just like control chart, the effectiveness for PA taken can be demonstrated in the trend chart)

0

5

10

15

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

每月客戶報怨件數

Example:

time

Keep monitoring the trend

PA taken

Root Cause:Poor training

PA effective


--Local Action --Management Action / Judgement ( 一般是當地 / 部門之對策 )( 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:

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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 」 !

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CA

Examples of Existing Nonconformities

進料檢驗發現有 26% 的原料是不良品。

今天一部機器生產的產品有30% 不符合客戶規格。

一個月之內有 20% 之交貨批遲交給某一特定客戶。

3 個月之內有 5 個客訴沒有處理。

PA

Examples of Potential Examples of Potential NonconformitiesNonconformities

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。

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 , 其他好幾個做同樣工作之操作員也會有同樣之潛在問題。

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CA Procedures

Accurately define an existing problem

( 正確定義現行 /已發生之問題 )

Investigate all root causes

(調查所有根本原因 )

Identify most probable cause(s)

(找出 /鑑別最可能之根本原因 )

Determine appropriate CA

( 決定適當之 CA)

PA Procedures

Accurately define a potential problem

( 正確定義“潛在問題” )

Investigate all potential causes

(調查所有潛在原因 )

Identify most probable potential cause(s)

(找出 /鑑別最可能之潛在原因 )

Determine appropriate PA

( 決定適當之 PA)

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CA Procedures

Implement CA

( 執行 /落實 CA)

Follow-up to verify effectiveness of CA prior to closure

(關案前之 CA 效果確認追查 )

Verify a minimum of twice prior to closure

(關案前至少效果確認二次 )

PA Procedures

Implement PA

( 執行 /落實 PA)

Follow-up to verify effectiveness of PA prior to closure

(關案前之 PA 效果確認追查 )

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三次 :PA 需要更長時間來做效果確認 )

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CA Procedures

Allow at least 1 month between each verification for CA effectiveness.

(CA 效果確認間隔時間至少一個月 )

PA Procedures

Allow at least 1 month between each verification for PA effectiveness.

(PA 效果確認間隔時間至少一個月 )

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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 small-step, ongoing improvement activities 之 continuous improvement( 持續改善 )

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-ISO 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.

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.

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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 effortsC.I.

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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！ )

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QS-9000 之 C. I. 之 intent 是 “好 ,還要更好 !”(good-better-best):

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 Cpk3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 attribute data results do not equal zero defects 屬於 NCP/C.A., 非 C.I.)

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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 !)

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－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。

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-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.

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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！

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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.

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-Fulfilling customer requirements does not necessarily ensure high customer satisfaction.-Assessors must see : Process that goes beyond customer complaint handling alone.

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- 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

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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。

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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！」

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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。

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( 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

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「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」 )。

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(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 :

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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。 )

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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 ! 」

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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 (top-town) 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……

239

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 )

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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。

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•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)。

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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.) 。

ISO 9004:

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再談「 PDCA 循環」當中

之

“ d” Segment 「執行」 !

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文件架構 (Clause 4.2 of ISO 9001:1994 & ISO 9001:2000) :

Job Instructions( 工作說明書／作業指導書 )

Quality Manual

( 品質手冊)

Level 1 ( 一階 )Defines Approach & responsibility (定義“方式”和 “權責” )

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 )

Quality Manual

( 品質手冊 )

Procedures( 程序書 )

Other Documentation ( 其他文件 )

Job Instructions

( 工作說明書 / 作業指導書 )

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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.

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- 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 !

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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！

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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。」

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--“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 PDCA…

Existing process CAPD…

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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… : 可視為一種 PA , 雖然 ISO 9001 無此要求 )

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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 ?

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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.

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* 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代表何意。 )

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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。

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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」

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→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。

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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

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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？ )

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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 , 也無法開啟瀏覽 !! 」

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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… )

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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… . 」 )

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(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!)

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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…。

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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 不一致！

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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！

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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)

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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 QS-9000 Implementation 部分有一段話 : All requirements of QS-9000 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auditor最常犯之錯誤— read too much!

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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！」

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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)

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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。

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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 inspectionsAuditor判定該 instruments 不必校正！ (Answer to (b) is NO)

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--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」

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--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 Set-Up), 自動檢測 (Auto testers)等需要放入 Control Plan 嗎？Yes, normally , 因為 High detectability (detection ranking 為2).

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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 !

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-- 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)。

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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 / 或現場稽核…等 )

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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 in-house 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!

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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)。

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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 !

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認證範圍認證範圍 ((Scope of Registration /Certification)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) 和服務 (service) 等。

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-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，必須去審查確認該排外之有效及正當性 (validity)。

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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這句話 !

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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。

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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 ﹝Sales Office﹞」。

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* 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。

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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。

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* 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off-sites/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」… .

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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 SIC code 為 7389)

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* 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.

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- 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。

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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

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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。 )

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-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” )

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-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 (輕微缺點 )嗎？

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• 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)

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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 re-evaluation shall be established. (ISO 9001:1994對 re-evaluation criteria 之規定很模糊 )

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•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？！）

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•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？

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•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pre-

existing 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

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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廠之案例 ) 。

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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 (QS-9000 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 FMEAs-

Process 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.

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ISO 9001: 1994 4.10.3 In-process Inspection and Testing-

The 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 Setups) rather than defect detection.

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QS-9000 4.9.4 Verification of Job Setups-

Job 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).

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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 System FMEA

(drive) DFMEA Subsystem FMEA

(drive) PFMEA Component FMEA

(drive)

Control Plan (CP) :

(drive)

Operators Instructions (OI)

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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。

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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

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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)

DCR/DCN 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 ) 。

(trigger) (trigger)

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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 /缺點預防而不是錯誤 /缺點偵測 ) 。

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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.

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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.

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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.

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• TC-176 對 ISO 9001:2000 之訂定 , 從 CD1CD2DISFDIS, 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 .

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MSA (QS-9000) vs. Calibration :

-Accuracy(bias) 準度 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 )

spec. tolerance ( 規格公差 ) (=1/4 min.) = 1/10 (ideal)

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-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！

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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 25% of the acceptance tolerance of a measurand.

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*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.

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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.

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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… )

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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需評估及記錄 ) 。

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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-of-specification condition (校正記錄需包括超出允收標準之情況所造成之影響之評估 ) 。

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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… )

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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 !) 。

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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)

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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 open-short) 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).

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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.

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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 (QS-9000, 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 included in the laboratory organization.

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※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 …

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* 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).

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「 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 ?

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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」 ?

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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。

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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!

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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」！

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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 .

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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

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(2) CAR, Customer Complaints, Field

Concerns/Problemstraced 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 !)

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(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 and experience.

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•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。 )

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• 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 )

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•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).

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• 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

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•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。

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•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 !

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• 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 powerful paradigm!

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(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, restaurant, 公廁 ..) & No.

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Last but not least , 最後談一談「 PDCA 循環」當中

之“ P” Segment 「規劃 /計劃」 !

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「凡事豫則立 , 不豫則廢」

Clause 5.4.2 之 QMS PlanningClause 7.1 之 Planning of Product RealizationClause 7.3.1 之 Design and development planningQS-9000之 APQP 新版 ISO 9001:2000 更強調 PDCA cycle 之 P (Plan) Segment

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“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。

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The Planning Pyramid( 規劃金字塔 )

Quality policy (5.3)( 品質政策 )

Quality objectives (5.4.1)( 品質目標 )

Quality planning (5.4.2)( 品質規劃 )

High level objectives

Specific objectives based on the quality policy and product requirements

Resources and QMS needed to achieve quality objectives & 4.1

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

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

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The Planning PyramidQuality 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 fixturesRevise workmanship standards and proceduresTrain personnel in workmanship standards and new quality system procedures

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Product Realization (產品實現 )

Focus: The need to plan, implement

and control work processes to

satisfy customer requirements

From ISO 9001:1994The 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

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7.1 Planning of Product Realization

(產品實現之規劃 )

From ISO 9001:19944.2.3 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。 )

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7.1 Planning of Product RealizationIn 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

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7.1 Planning of Product RealizationWhat you must see

A process for, and evidence of, planning which addresses (a)-(d), as appropriate:e.g. APQP/CFT

What you might seePlanning 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

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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, SpecificationsProcess approval documentation ( 流程核准文件 ) e.g. PPAP recordsBOM’s

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7.1 Planning of Product RealizationRemember: 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?)

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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/First-

Article 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-to-Stock 」 ) 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 /

價值 /策略 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 Project Mgm’t & Results Evaluation

專案管理 & 結果評估

SWOTAnalysis

Mgm’tReview

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※ 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 • Aims for a realistic accomplishment, with

or opportunities for better performance and new

challenges.

Actionable

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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 competitors.

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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 highest-priority 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 highest-priority 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 its impact, to 「 counter 」 (抵抗 ) the threat.

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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 ( 利用優勢 ) Strengths:6. Broad range of services. :13. Local service capacity:

( 降低 / 改進劣勢 & 劣勢產生之影響 ) Weaknesses:

7. High prices vs. competition:

19. Rigid hiring/HR policies.:

( 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)**:

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.:

( 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)***:

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.::

外在分析

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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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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 pertinent linkage.

※Example of Strategic Planning Process for Mfg Organization (Partial)

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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 9001:1994-registered) 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 successful registration upgrade.

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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。

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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，的確難以計量，故宜先改善直線作戰單位。

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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 performance)。

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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( Measure & Manage strategy! e.g. BSC):

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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, zero-defect, 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 management system)。

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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。

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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

Deployment System

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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 non-controlled 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？

Documents

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

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