1、,Corrective Action Process & Problem Solving,糾正措施程序和問題的解決,2,Introduce the corrective action process Improve participation Build consensus Improve the implementation of corrective actions Problem identification Root-Cause analysis Develop communication strategy Assist implementation,Objectives 目的,介紹糾
2、正行動程序,改善參與性,建立共識,改善糾正行動的推行,分辨問題,分析問題根源,發展溝通策略,協助推行,3,The Process,Audit,Returns,Warehouse,End-of-Line,Report,CAR*,ID the problem,Root Cause,Verify,Permanent Fix,Prevent,Contain,Solutions,抑制,審核,防止,退貨,貨倉,成品,報告,糾正申請單,分辨問題,解決問題,驗證,根源,問題解決辦法,4,Purpose Identify defects Implement Corrective Actions Types En
3、d-of-Line Audit Warehouse Returned Product,Audits,審核,目的,找出問題,推行糾正措施,種類,成品審核,貨倉,退貨,5,End-of-Line Audit At manufacturing plants in accordance with product quality plans Close to source Lowest expense to correct a defect “100% audit 80% effective” Shift from end-of-line to “Line” Everyone is responsibl
4、e for Quality,Audits Types,審核種類,成品審核,依產品品質計劃在制造廠審核,接近貨源,糾正缺陷的最低成本,100%審核 80%有效,改“成品審核”為“生產線上審核”,每一個人都有品質責任,6,Warehouse Consumer focus Address transportation/handling damage Very little to no technical assessment Third party Damaged product segregated for further analysis Limited sample Springboard t
5、o deeper understanding,Audits Types (cont.),審核種類,貨倉,客戶為主,糾正付運時損傷,很少技術評估,用第三者,隔離損壞產品以便分析,有限樣本,作為跳板以進一步了解,7,Returned Product Failure analysis Closest representation of warranty issues 保證期退貨問題的最佳代表性 Team approach Engineering Marketing Quality Manufacturing NAD identification and analysis Cost of return
6、s assessment Follow-on investigation at Mfg plants,Audits Types (cont.),退貨,故障分析,團隊模式,工程,品質,業務,制造,NAD識別及分析,退貨成本評估,跟蹤調查制造廠家,8,Content Executive summary Defect details Sample size Date Code Digital pictures PPM Examples Internal Externals,Audits Reports,內容,總述,問題描述,樣品量,生產日期,數據圖片,例子,內部,外部,9,What is a CAR
7、? Communication tool Who,What, When, Where, Why, How, How many Tracking method What are the plans and contingencies? 有何計劃和后備計劃Assignment of responsibility Who is leading the effort? Do we need more assets? Status report Where are we with respect to our plan?,Corrective Action Request (CAR),CAR是什么?,溝
8、通工具,誰 什么 何時 哪里 為何 怎么 多少,跟蹤方法,職責分配,誰是領導?是否需其它資源,狀態報告,根據計劃,我們的進度如何,10,CAR The Form,11,CAR The Form (cont.),12,Boiler plate stuff Site, Coordinator, Model & Type, Date Code, Date issued Where does it originate from Need to add Plant, Team Leader, and members of the team Here is where the defect is stat
9、ed - Symptom,CAR The Form (cont.),燃爐板事宜,場地,協調者,模型和型號,生產日期,分發日期,需加上廠家,團隊領導和團隊成員,源自于哪里?,此處闡述問題在哪里 - 預兆,13,CAR The Form (cont.),Describe the Problem Specify the problem by identifying, in quantifiable terms, the who, what, when, where, why,how and how many for the problem. Failure to properly identify
10、the problem will surely lead us to solve something else Do not wait until all the questions are answered to start the process,描述問題,通過5W 1H使問題能夠量化與識別,未能正確地識別問題的性質將導致我們解決其他列無關的問題,不要等到所有問題都有答案之后才啟動這個程序,14,CAR The Form (cont.),Corrective Actions taken Define containment actions to isolate the effects of
11、 the problem. Need to know the number contained and where. Any results from a sort and how these were identified Dates and responsibilities must be included,采取糾正措施,介定遏制行動以隔離問題的影響,需知道被抑制的數目或地方,從某一種類中的任何結果和怎樣識別,必須包括期限與責任,15,CAR The Form (cont.),Root Cause Analysis Identify all potential causes. Isolat
12、e and verify the root cause by testing. Can you turn the problem “On and Off” Again dates and responsibilities must be included,根源分析,識別潛在的原因,通過測試分離和驗證根源,你是否可以把問題復制,必須包括期限與責任,16,CAR The Form (cont.),Preventive Actions These are the permanent corrective actions designed to preclude the problem from re
13、surfacing 這是永逸行動以排除問題的重生 Plan of action and milestones Need to quantitatively confirm that these actions will solve the problem and will not create new ones! Control plan Our actions must address standardization (systems & procedures),預防措施,措施的計劃和里程碑,須確保這些措施能解決問題且不會引發新的問題,控制計劃,我們的措施需有標準(系統和步驟),17,CAR
14、 The Form (cont.),Closing the loop Need to work to a plan when will actions be completed and when they are accomplished. Coordination with Product Hold Process Collection of lessons learned into a company wide database,需按計劃工作,措施應于什么時候完成,是何時完成的,與產品暫停付運相協調,在整個公司範圍內收集經驗教訓,掃尾工作(解決問題必須有頭有尾),18,A DEFECT I
15、S NOTED,SUBMIT DEFECTTO CAR COORD,SUBMIT CAR TO PLANT COORD.,PLANT COORD ASSIGNS TO TEAM LEADER,TEAM LEADER ORGANIZES TEAM 團隊領導組織團隊,DEVELOP CONTAINMENT PLAN,CONDUCT PROBLEM SOLVING,EXECUTE PERMANENT CA PLAN,TEST & VERIFY,CLOSE CAR AND SEND BACK TO CAR COORD.,INCORPORATE INTO DATABASE,AUDIT,HOLD,FEED
16、BACK,CAR LIFECYCLE,提交問題給CAR協調者,問題被發現,審核,提交LAR給廠方協調者,廠方協調者分 配給團隊領導,問題定義,存入資料庫,關閉CAR并送回給CAR協調者,測試和驗證,執行永久性的CA計劃,反饋,指導問題的解決,創建遏制計劃,根源分析,永久糾正措施計劃,19,Objective Assist in the identification, solution and prevention of recurring problems,PROBLEM SOLVING,解決問題,目標,協助識別,解決和預防問題再發生,20,Problem Described Incorrec
17、tly Problem Solving Effort Expedited Poor Team Participation No Logical Process Lack of Technical Skills Managements Impatience Potential Cause Confused with Root CausePermanent CA not Implemented,PROBLEM SOLVING INHIBITORS,解決問題的抑制因素,問題描述不正確,解決問題過于從速,缺乏團隊參與,沒有邏輯性的程序,缺乏技術技能,管理層過於急躁(或沒有耐心),潛在原因與根源混淆,永
18、久性的CA沒有推行,21,Designate a team Describe the problem Define and implement containment Define and verify root-cause Define and verify contingency actions Define and implement permanent CA Determine a plan to prevent recurrence Disseminate to the rest of the organization,PROBLEM SOLVING PROCESS,8Ds,問題解決
19、程序,指定一個團隊,描述問題,明確并推行遏制政策,介定并驗證根源,介定并驗證偶然的行動,介定并實施永久性糾正措施,決定一個計劃以防問題復發,向組織的其他部分宣傳,22,ESTABLISH A TEAM LEADER,Is the team size correct?,Are all persons with process/product knowledge and work experience represented who can resolve the problem?,Select individuals to participate on the team,Establish th
20、e time and authority required to work on the problem,Establish team advisors to assist in problem solving,DESCRIBE THE PROBLEM,NO,NO,YES,YES,USE TEAM APPROACH,建立一個團隊領導,選擇個體來參與團隊,所有參加的人都有程序 或產品知識及經驗嗎? 誰能解決問題?,團隊規模正確嗎?,為解決問題要求 建立的時間和權威,建立團隊顧問以協助解決問題,描述問題,23,Objective Establish a small group of people
21、with the right tools to solve the problem and implement CA.Team Members Are the people affected by the problem represented?What should the membership consist of? Does everyone belong? Are responsibilities clear? Product/Process Knowledge What is the main issue? Who is affected by the problem,DESIGNA
22、TE A TEAM,指定一個團隊,目標,建立一個擁有正確工具的小團體來解決問題并實施CA,團隊成員,是否是被出現的問題影響的人,成員應包括哪些人?,是否每一個人都有代表性?,職責明確嗎?,產品或程序知識,主要問題是什么?,誰被這個問題所影響?,24,Team Administration Decision making authority at lowest level?決定權是否在基層人員手里? Is the Customer viewpoint represented?How will information be communicated internally & externally?
23、Authority Who is the designated Champion of the team,DESIGNATE A TEAM (cont),團隊管理,顧客的觀點被考慮了嗎?,信息的內外溝通怎樣進行?,權威,誰被指派為團隊的先鋒,25,Keep size small (4-10 )Ensure the right knowledge is presentEvaluate need for advisors (special skills)Identify expected commitment (time, etc.)Designate frequency of meeting a
24、nd reportsRe-evaluate performance and new needs constantly,DESIGNATE A TEAM (cont),確保團隊里有相應的知識,評估是否需顧問(特別技能),識別期望的承諾(時間等),確定會議和報告的頻率,重新評估運作和不斷的新需求,維持小團隊,26,Establish the data base that exist for problem description,Can the problem be subdivided?,Collect current and historical data as needed to furth
25、er quantify the problem,Prepare a process flow diagram for all product stages,Describe the problem in terms of an operational definition,Have the extent and distribution of problem been established?,Ask who, what, when, where, how, how much,NO,YES,Describe the Problem,Analyze similar situations,Cons
26、ider a second team,Implement Interim corrective actions,建立描述問題的資料庫,準備所有產品 的制程流程圖,為進一步量化問題收集 所需的現存和歷史資料,考慮第二個團隊,問題可否細分,以操作性的定義 述語描述問題,問題的範圍的分 布狀態建立了嗎?,問誰,什么,何時,哪里,怎樣,多少,分析類似的情形,推行臨時糾正措施,27,Objective Specify the problem by identifying in quantifiable terms who, what, when, where, why, how, how many (5
27、w2h)Type of problem Type (field complaint, quality audit, etc.) Resources & documents that can help specify Are there more than one problem? (subdivision) Is/ Is Not Have we seen this problem before? Has it appeared in another plant or line?,Describe the Problem,目標,通過大量的術語來詳細說明問題,如:誰,什么,何時,哪里,為什么,怎樣
28、,多少,問題的類型,類型(客戶投訴,質量審核等),是否不止一個問題,是/否,以前是否見過此類問題?,是否出現在其它廠或生產線,28,Questions What is the extent of the problem? Has the problem been increasing, decreasing or constant?Is the process stable? What indicators are available to quantify the problem?Can you determine severity? Do we have physical evidence
29、? Have failed parts been analyzed? Who, What, When, Where, Why, How, How Many,Describe the Problem,問題,問題的範圍是什么?,問題在增長,縮減還是保持不變?,程序穩定嗎?,量化問題可獲得的指標是什么?,你能決定嚴重性嗎?,是否有有形的證據?,故障部件有沒有分析過?,誰,什么,何時,哪里,為何,怎樣,多少,29,Who? Identify customers complaining 誰 -識別顧客投訴 Internal and External 內部和外部的 What? Describe the p
30、roblem adequately 什麼 -充分描述問題 Severity; operational definitions 嚴重性,操作性解說 Measurement system (Gage R Cyclical nature? What has changed?換班時還是循環時?什麼改變了? Why? identify known explanations 為何 - 識別已知的解釋 How? In what mode or situation did it occur 怎樣:發生模式和狀態怎樣 How many? Quantify the problem 多少:問題的數量,5Ws&2Hs
31、,30,Identify containment actions 識別遏制措施,Implement and verify actions on a test basis (collect Data) 在測試的基礎上實施和驗證措施(收集資料),Has the effect been isolated from the customer? 影響是否已與顧客隔離,Establish Action Plan 建立 措施計劃,Is the effect eliminated? (Collect Data) 影響是否消除?,Implement action Plan 措施實施計劃,NO,NO,YES,YE
32、S,CONTAINMENT ACTION 遏制措施,31,Objective 目標 Define and implement efforts to isolate the effect from all customers(internal & external) until corrective actions are put in place 努力使影響從所有的客戶分離出來(內部和外部的)直到糾正措施實行了 Verification 驗證 Check all possibilities 檢查所有可能性 Designate responsibilities and identify supp
33、ort needed 指定職責並識別所需的支持 Timeliness and effectiveness (test) 適時性及有效性 Actions 措施 Stop the hurt. Dont create new problems 停止痛苦,不再創造新問題 Do these actions give enough time to implement permanent CA? 這些措施是否提供足夠的時間來實施永久性的CA Keep Customers informed 及時通知顧客,CONTAINMENT ACTIONS 遏制措施,32,Common Actions 普遍措施 100%
34、sorts 100%分類 Temporary inspection 臨時性檢驗 Temporary change of suppliers 供應商的臨時變更 Increase tool maintenance 增加工具維護 Purchase parts rather than manufacture in-house 寧願採購零部件而非自己生產 Common Pitfalls 普遍缺陷 Not timely enough 不夠適時 Mistake for permanent fix 永久性的解決辦法有誤 Delay due to cost 由於成本而耽擱 Do not completely i
35、solate customer from effect 沒有把顧客與影響完全隔離,CONTAINMENT ACTIONS 遏制措施,33,CONSTRUCT A PROCESS FLOW (ALL VARIATIONS) 創建一個程序流程(所有變量),CRITICAL DIFF. PROBLEM AND NON PBM AREAS,CAUSE & EFFECT POTENTIAL CAUSES,INPUT FROM ALL TEAM MBRS,TIME-LINE ANALYSIS,LIST THE POTENTIAL CAUSES,ANALYZE POTENTIAL CAUSESFOR LIK
36、ELY ROOT CAUSE,WHAT DATA NEEDED TO ID ROOT CAUSE,COLLECT DATA AND INFORMATION,ANALIZE DATA 分析資料,DATA ID CAUSE AS ROOT CAUSE?,ID ALTERNATIVE SOLUTIONS,IMPLEMENT SOLUTIONS ON PROTOTYPE BASIS,IS PBM LEVEL REDUCED?,IS PROBLEM ELIMINATED?,YES,YES,YES,NO,NO,NO,NO,IMPLEMENT PERMANENT CORRECTIVE ACTION),YES
37、,ROOT CAUSE ANALYSIS 根源分析,原因和影響 潛在原因,收集資料和信息,識別根源所需數據,給可能的根源 分析潛在原因,列出潛在 原因清單,在原型基礎上 實施解決辦法,問題程度是否縮減,問題是否被排除,實施永久性糾正措施,從所有團隊 成員輸入,評判不同的問題和無問題區域,分辨備選解決辦法,時間段分析,原因和根源的分辨資料,34,Objective 目標 ID all potential causes. Isolate and verify the root cause by testing each cause against pbm description and test
38、data 識別所有潛在的原因,根據問題的描述和測試數據來分離和驗證根源。 Potential Causes 潛在原因 Draw a process flow diagram and id all variation 畫一個程序流程圖並識別所有變量 Can a link be established between pbm and process 問題和過程之間是否可以建立聯繫 Multiple Whys 若干個為什麼 What changed? 改變了什麼 Why havent we seen this before? 為什麼以前沒見過?,ROOT CAUSE ANALYSIS,35,Data
39、 資料 What data is available to highlight changes in process 可有突出過程變化的數據? Root Causes 根源 How does each potential cause explain all we know about the problem 每一個潛在的原因如何解釋我們所知道的所有問題 What is the concern that each potential cause is actually occurring 每一個潛在原因是否實際上有發生? “The Switch” 開關 Can you turn the prob
40、lem “On” and “Off” by manipulation of the root cause 是否可通過對根本原因的詷控使問題復現與復失,ROOT CAUSE ANALYSIS (cont),36,Identifying Potential Causes 識別潛在原因 Use cause-and-effect diagram to brainstorm 採用原因與影響圖來集體討論 Review all data for clues to potential causes 評審所有潛在原因及線索資料 Time-line analysis can highlight important
41、 clues 通過對時間段的分析可以突出重要提示 Customers Input 顧客意見與建議 Who has seen the problem first hand? 誰最先發現問題 Survey internal and external customers 調查內部和外部的顧客,ROOT CAUSE ANALYSIS (cont),37,Select likely potential causes選擇可能的潛在原因 Re-evaluate team membership 重新評估團隊成員資格 Each member study own processes for likelihood
42、每一個成員研究自己過程發生的可能性 Do not narrow search too much (initially) 不要有太多的局限(最初時) Considerations 深思熟慮 Are processes stable? 所有的過程是否穩定 Are measuring system reliable, repeatable and accurate 量度系統是否可靠,可重復的及精確的 Identify Alternate Solutions 識別備選的解決方法 Evaluate several approaches to solve the problem 評估幾個方法來解決問題 A
43、void Band-Aid fixes 避免權宜之計,ROOT CAUSE ANALYSIS (cont),38,ID alternative solutions 識別備選的解決方法,Implement Permanent Corrective Actions 實施永久性的糾正措施,Remove Interim Actions 撤除臨時措施,Set on-going controls to ensure permanent fix is verified 設置連續的控制以確保永久性決定被驗證,Establish implementation Action Plan with actions,
44、responsibilities, timing, and required support. ID contingency actions 建立實施措施計劃,包括措施,權責,時間,所需支持,識別後備措施,PERMANENT CORRECTIVE ACTIONS 永久性的糾正措施,39,Objective 目標 Define and implement the best permanent corrective actions. Set controls to verify root cause eliminated. Monitor long term effect to implement
45、 contingencies. 闡述並實施最佳的永久性糾正措施,設置控制以驗證根源已清除 Corrective Actions 糾正措施 Are these the best possible long term solutions? 是否為最佳的長期解決辦法 Take into consideration the cycle plan for the product 產品的循環計劃應納入考慮 Must have an Action Plan 必須有行動計劃 Defined steps 闡明步驟 Clear responsibility 職責明確 Logical timing 合乎邏輯的時限
46、Needed Support 所需支持,PERMANENT CORRECTIVE ACTIONS,40,Controls 控制 Make sure the problem will not reoccur 確保問題不會再發生 Try to eliminate audit based controls 盡量消除基於控制的審核 Test the control system by simulating the problem 通過模擬問題來測試控制系統 Other considerations 其它考慮因素 Does the customer agree with our actions? 客戶是
47、否同意我們的措施 Take into consideration the potential side effects 要考慮潛在的副作用 Try to predict outcomes - DOEs 盡量預測結果 DOEs Ensure interim corrections are removed 確保臨時糾正已被清除,PERMANENT CORRECTIVE ACTIONS,41,Process Flow of management/operating system 管理和運行系統的程序流程,Disseminate new actions to all involved personne
48、l 向所有相關人員宣傳新措施,Change management system to avoid recurrence 變更管理系統以防止再發生,Standardize new practice 使新的經驗標準化,PREVENT RECURRENCE 預防再發生,42,Objective 目標 Correct management and operating systems to preclude this or similar problem to occur again糾正管理和運行系統以防止該問題或類似問題再發生 Mopping-up掃尾工作 Communicate resolution
49、 actions交流解決措施 Take the same approach with management system as taken with manufacturing process在管理系統采取與生產程序相同的方法 Standardize practices to preclude same problem different line syndrome使操作標準化以排隊同樣問題在不同的生產線并發 There may be strong inertia to overcome poor or outdated management practices在克服落后的或過時的管理時可能會有很強的慣性,
