快速反應(yīng)程序：解決質(zhì)量問題反應(yīng)模式

1、快速反應(yīng)程序：解決質(zhì)量問題反應(yīng)模式 是一個體系運用可視的方法顯示重要的信息以解決重大的外部的、內(nèi)部的質(zhì)量失效問題?？焖俜磻?yīng)是否存在一個每天的領(lǐng)導層會議？ 快速反應(yīng)會議可以是一個1020 分鐘的站立式會議，地點可以在車間或生產(chǎn)會議室。 過程的責任人必須來自制造部門。 在一天的開始，質(zhì)量小組應(yīng)該識別前24小時所發(fā)生的重大質(zhì)量問題 ，可以從一下幾個方面考慮:- 客戶關(guān)注的問題- 供應(yīng)商所關(guān)注的問題- 造成停線的 (內(nèi)部/客戶)問題- 出廠審核 / 審核問題- 其他內(nèi)部質(zhì)量問題研討會小組首先應(yīng)該定義什么樣的質(zhì)量問題是重大的質(zhì)量問題。當業(yè)務(wù)經(jīng)理不在場時，會發(fā)生什么呢？ 在每天的制造評估會議上領(lǐng)導層應(yīng)該審

2、核一下方面:- 和小組成員一起審核重大的質(zhì)量問題- 指定相關(guān)人員負責問題的解決- 指派下次會議報告的責任人要求 (續(xù)): 責任人應(yīng)該負責保證所有的問題及時被解決并且滿足退出標準。 責任人的報告應(yīng)包含以下幾個方面的更新：- 快速反應(yīng)跟蹤表- 標準化操作指導書- 問題解決表 - 過程失效模式分析- 控制計劃- 層級審核- 全員通告 Workforce Notification - 其他適用文件必要時在快速反應(yīng)跟蹤表上必要時，按照快速反應(yīng)跟蹤表的規(guī)定匯報給管理層 快速反應(yīng)跟蹤表 (Example)要評估的要點:責任人退出標準全面情況優(yōu)化目視管理，將這個表格盡可能大的顯示在會議室( ex.: 4 x

3、8 dry erase board )(舉例)領(lǐng)導層將展示一個可視的質(zhì)量狀況要求 (continued):不合格產(chǎn)品的控制遏制Establish a method to ensure that product that does not conform to specified requirements is:防止無意識使用或安裝 Prevented from unintended use or installation 用統(tǒng)一的標簽清楚識別 Clearly identified using consistent labeling 用目視管理方法建立統(tǒng)一的識別程序 (Example) 用明亮色

4、彩作為首選的識別方法 - 紅色廢品 - 黃色可疑品 - 綠色合格品不合格產(chǎn)品的控制標簽內(nèi)容IN THIS SECTION IS AT LOCAL DISCRETION標簽內(nèi)容IN THIS SECTION IS AT LOCAL DISCRETIONPLT001可疑品或待處理品半成品或合格品紅標簽表示廢品。 黃色標簽表示可疑產(chǎn)品或待處理的材料，需要返工的材料或需要進一步檢查的材料綠色或其他顏色的標簽表示產(chǎn)品是可接受的 (紅色和黃色除外). .廢品PLT002PLT003標簽內(nèi)容IN THIS SECTION IS AT LOCAL DISCRETION要求:不合格產(chǎn)品的控制 領(lǐng)導層應(yīng)開發(fā)，組織

5、并維護一個統(tǒng)一的體系來控制不合格品. 將不合格產(chǎn)品隔離. 隔離區(qū)域?qū)⒈粯俗R - 廢料箱- 返工臺- 返工產(chǎn)品標簽- 溢出遏制區(qū)域 遏制工作表將被完成并用于：提供一個系統(tǒng)的方法遏制全部可疑品 確定不合格產(chǎn)品的檢查范圍What if potentialquantitydoes not equal total found? When do you call the customer?要求 (續(xù)): 分界點檢驗采用:- 對于遏制范圍內(nèi)的產(chǎn)品100檢查- 在根本原因找到之前，持續(xù)時間由領(lǐng)導層決定 對于產(chǎn)品遏制問題，箱子將標識成 :- 紅色不合格產(chǎn)品 - 黃色可疑品- 綠色分界點后的合格產(chǎn)品 從被認可的工

6、藝流程上拿走的產(chǎn)品返回時應(yīng)在離開點或之前. 全部控制計劃都要執(zhí)行檢查和測試. 注意： 如果不可能在離開點或之前返回，使用經(jīng)認可的重做流程以保證一致性. 要明確脫離返工，返修和遏制區(qū)產(chǎn)品的程序與授權(quán). 產(chǎn)品遏制問題要經(jīng)領(lǐng)導層評估. 標準化工作(方法和順序)“標 準 化 是 通 往 不 斷 改 進 之 路.”W.E. Deming,七月 15, 1992(舉例)目的: 對所有的操作實施標準化的方法和順序。標準化工作 (方法& 順序)范圍: 裝配區(qū) 制作過程 發(fā)運 / 收料 返修/返工區(qū) 所有的操作 其他支持功能 (例如：檢查) 職責: 一個或兩個責任人- 制造工程人員- 生產(chǎn)經(jīng)理 精益組織. 識別

7、那些能增值的工作. 一個有效的生產(chǎn)順序. 持續(xù)改進. 在過程內(nèi)部減少變差. 減少浪費，解決問題和質(zhì)量控制. 審核操作員與工作指導書一致 層級審核. 確保操作者統(tǒng)一履行相同任務(wù)和程序.標準化的工作提供了一個基礎(chǔ): 多功能小組應(yīng)確定并列出所有要實施標準化的工序Multi-disciplinary team(s) shall identify and list all operations to implement standardized work怎樣劃分優(yōu)先順序的例子:- 涉及客戶質(zhì)量的問題 - 定義工作順序和方法的必要性- 離線返工Off-line Rework- 高的RPN- 員工流動Emp

8、loyee Flow-through多功能小組定出標準化工作的指導書并張貼到每一工位.新員工要被培訓使用標準化工作（標準操作員培訓）要求:標準化操作Standardized Operations客戶周期時間工作順序在制品的標準化標準化操作步棸TAKT TIME 生產(chǎn)出一個單位的時間Time in which a singleunit is to be produced操作工的移動OperatorMovements相同順序相同動作每一循環(huán)工作需要的最小庫存Minimum stock necessaryto do work in the samesequence with the same mov

9、ements, every cycle列出客戶周期時間的理由: 使領(lǐng)導層確信業(yè)務(wù)如批準的那樣在運轉(zhuǎn)Assures leadership that operation is running as approved 可減少生產(chǎn)過剩 Overproduction can be reduced 改進生產(chǎn)調(diào)度 Improves production scheduling 操作員可介入到?jīng)Q策過程Operator involved in decision making process 設(shè)備顯示出磨損跡象時操作員能知道Operator knows if equipment is showing signs o

10、f wear. 安排維護與修理時間 Maintenance and repair time allocated 清掃成為生產(chǎn)流程的一部分Clean-up becomes part of the production process 質(zhì)量檢查變成日常事務(wù)Quality checks built into the daily routine 為實施分層審核而安排時間Time allocated for conducting Layered Audits 目視管理元素 顯示工作順序的理由: 所有的操作每次都以相同的方式完成All operations are performed the same w

11、ay every time 減少組分被遺漏的風險Reduces the risk of components being left out 沒有操作被遺漏或忽略No operations are skipped or omitted 提醒進行質(zhì)量檢查及頻率Quality checks and frequency are called out 很容易確定方法改進Process improvements are easily identified 新手培訓更一致Training new operators is more consistent顯示標準工作程序的原因: 操作員控制再填充箱柜的頻率Op

12、erator controls frequency of refilling bins 警告材料管理員短缺或過量庫存Alert material handler of shortages or excess inventory 減小由于原料儲運損耗而造成的設(shè)備停工期Reduces equipment downtime due to stock outages 工作區(qū)域減少混亂 減少在制品 允許材料管理員處理他們的時間Allows material handler to manage their time Standardized Operations Worksheet And Layout標

13、準化操作工作表和布局STEPNO.WORKSTATION AREA DRAWN TO SCALEOPERATION: FROM:_QUANTITY PER SHIFT:_CUSTOMER CYCLE TIME:_ TO: _SHIFT:_OPERATOR CYCLE TIME:_WORK ELEMENTELEMENT TIMESTANDARD IN-QUALITYCRITICALHAND WORKMACHINEWALKPROCESS STOCKCHECKOPERATIONSAFETYCQTOTAL(Example)標準化的操作工作表和計劃應(yīng)包括Standardized Operations W

14、orksheets And Layout shall include:- 工作原理Work Elements- 操作員動作Operator Movement- 操作周期時間Operation Cycle Time(Example)(Example)要求（續(xù)）: 標準化的工作說明書應(yīng)通過分層審核檢驗任何操作在持續(xù)12個月里由于缺乏堅持標準化的工作說明出現(xiàn)的不一致Standardized work instructions shall be verified through Layered Audits for any operation which shipped a non-conforman

15、ce within the last 12 months due to a failure to adhere to standardized work instructions. 多功能小組應(yīng)根據(jù)正在進行的質(zhì)量成績對標準化的工作說明書做持續(xù)的改進Multi-disciplinary team(s) shall continuously develop/improve standardized work instructions based on ongoing quality performance.操作員培訓的標準化操作員的培訓是否經(jīng)過驗證并記錄在案？ 操作員標準化培訓要求Standard

16、ized Operator TrainingRequirements多功能小組決定每一道工序至少的培訓內(nèi)容A cross functional team shall define the minimum training content for each operation.此組織決定誰來實施培訓The organization shall identify who will conduct training.培訓員監(jiān)督新操作員的行動，必要時重新培訓以確保標準工作指導被遵循Trainers shall monitor new operators activities and retrain i

17、f necessary to assure Standard Work Instructions are being followed.培訓員通知下道工序潛在的缺陷The trainer shall notify downstream operations of potential defects.此組織應(yīng)建立必要的文件及跟蹤方法The organization shall establish required documentation and tracking methods.培訓者應(yīng)指導操作員使用標準操作員培訓表Trainers shall instruct operators usin

18、g the standard operator training sheet. (Example)標準化操作培訓記錄(Example)Application: 運用：任何新操作員都應(yīng)完成下表The following shall be completed with any new operator (for any given operation).審核Review 完成Complete標準化的工作指導Standardized work / job instructions要填充的質(zhì)量記錄Quality records to be filled out (eg. Check sheets)示范

19、操作和問題回答Demonstrate the operation and answer questions示范測量和回答問題Demonstrate gaging and answer questions新員工是否進行操作并回答問題Have new employee run operation and answer questions講授過去的問題Teach past problems (eg. FMEA, Top Problems List)檢驗首次生產(chǎn)，培訓作為必須Verify first units produced, coach as needed換班時報告，重新檢驗標準化的工作與產(chǎn)品質(zhì)

20、量Return within the shift, verify std work & product quality again大約1天報告，重新檢驗標準化的工作與產(chǎn)品質(zhì)量Return in approx. 1 day, verify std work & product quality again向下游業(yè)務(wù)通報潛在缺陷Notify downstream operations of potential defects雇員簽名Employee Signature _ 培訓員簽名Trainer Signature _Operation Name and # _零件（產(chǎn)品）功能Part (prod

21、uct) function安全/設(shè)備操作 Safety/ Equipment Operation(Example)標準化的操作培訓記錄 標準化操作員培訓要求操作員跟蹤表應(yīng)張貼在每一操作位置通過分層審核檢驗Operator Tracking Sheets shall be posted at each operation and verified through Layered Audits.Scheduling of refresher training for assigned operators is at local site discretion.追加的雇員如果在最近三個月內(nèi)沒有經(jīng)過培

22、訓不能執(zhí)行工作Supplemental employees shall not perform the job unless they have been trained within the last three months.培訓者應(yīng)定期檢驗質(zhì)量以確保達到所有的標準。最起碼培訓者應(yīng)在一個換班與一天內(nèi)報告。The trainer shall verify quality at a frequency determined necessary to assure all standards are met. At a minimum the trainer shall return withi

23、n the shift and again within approximately one day.操作員培訓應(yīng)記錄在“操作員培訓跟蹤表”里Operator training shall be tracked on “Trained Operator Tracking Sheets”. (Example)已培訓操作員跟蹤(Example)Operation Name / # _DEPT. ASSIGNED EMPLOYEESUPPLEMENTAL EMPLOYEELATEST TRAINING DATE AND TRAINER INITIALSLatest Job Instruction R

24、ev. Date標準化的培訓小結(jié)組織應(yīng)該建立必要的文件和跟蹤方法確定操作員培訓負責人。保證操作員培訓通過“操作員培訓跟蹤表”跟蹤 ensure operator training is being tracked on “Trained Operator Tracking Sheets”. 在每一操作位張貼操作員跟蹤表，通過分級審核檢驗 post operator Tracking Sheets at each operation, and verify through Layered Audits.schedule refresher training for assigned operat

25、ors at local site discretion.降低風險的程序積極主動RPN 降低程序:降低潛在質(zhì)量失效被動對已發(fā)生的質(zhì)量失效建立防錯裝置定義PFMEA結(jié)構(gòu)化程序適合于與失效模式有關(guān)的識別和排除方法A structured procedure for identifying and eliminating process related failure modes.識別每一個過程步驟的分析技術(shù) An analytical technique that identifies for each process step程序可能不能達到要求的情形 Ways that a process m

26、ay fail to meet requirements內(nèi)在/外部消費者的嚴重度Consequences to the internal / external customer (嚴重度)失效可能發(fā)生的頻率Frequency that the failure will/could happen (發(fā)生頻率)當前控制的效果Effectiveness of current controls (預(yù)防核可探測度)原因和結(jié)果的排隊Ranking of causes and effects (風險順序數(shù))會出現(xiàn)什么問題What can go wrong?它是怎樣影響客戶的How does it affec

27、t customer?多久發(fā)生一次How often does this cause happen?如果問題發(fā)生，有多大可能我們會注意道它How likely are we to notice if this happens?風險程度有多高How high is the risk?PFMEA: 過程失效模式及影響Process Failure Mode & Effects (example)(AIAG PFMEA Third Edition)嚴重度分級Severity Rankings(AIAG PFMEA Third Edition)發(fā)生頻率分級Occurrence Ranking(AIAG

28、 PFMEA Third Edition)可探測性分級Detection Rankings(AIAG PFMEA Third Edition) 風險順序數(shù)是嚴重度，發(fā)生頻率與可探測性結(jié)合在一起的結(jié)果Risk Priority Number (RPN) is the result of Severity, Occurrence and Detection rankings.(Example)嚴重度Severity x 發(fā)生頻率Occurrence x 覺察可能Detection = RPN風險順序數(shù)Risk Priority Number (RPN)所有的質(zhì)量管理體系要求的制造步驟與支持功能如接

29、受檢查、材料處理、分類與發(fā)運等都要完成PFMEAs shall be completed for all manufacturing processes and support functions such as receiving inspection, material handling, labeling and shipping,etc as required by the Quality Management System. PFMEAs 必須: 與AIAG的原則和客戶的要求相一致 定期更新（動態(tài)文件） 所有的生產(chǎn)線/產(chǎn)品號都有相應(yīng)的PFMEA 包含所有過程和工序 應(yīng)用于持續(xù)改進 準

30、確定義嚴重度/頻率/可探測度的等級主動降低風險的要求Site Leadership 領(lǐng)導層最起碼每年一次評估PFMEA培訓需要Leadership should review the need for PFMEA training at least once per year. 領(lǐng)導層應(yīng)支持RPN減少活動并提供必需的資源Leadership shall support RPN reduction activities and provide necessary resources. 領(lǐng)導層應(yīng)評估RPN減少跟蹤表RPN reduction tracking charts shall be rev

31、iewed by leadership. 領(lǐng)導層應(yīng)確保PFMEA的準備與評估利用了正規(guī)的多功能小組Leadership shall ensure that formal multi-disciplinary teams are utilized in the preparation and ongoing review of PFMEAs.主動降低風險的要求主動降低風險的要求 根據(jù)過程的穩(wěn)定性，顧客的反饋等，供應(yīng)商領(lǐng)導層決定PFMEA評估的頻率（如每月一次）Based process stability, customer feedback, etc and supplier leadersh

32、ip shall determine the frequency for PFMEA review. ( ex.:once per month) PFMEA應(yīng)經(jīng)歷完整的評估包括以下內(nèi)容：PFMEAs shall undergo a complete review including the following: 確認所有的操作/步驟都被包括進去而且準確Verification that all operations/processes are included and accurate. 所有操作控制都被包括進去而且準確All process controls are included and

33、 accurate.通過數(shù)據(jù)分析了可能性排隊Occurrence ratings are analyzed using data (SPC, FTQ, Quality Gate, C.A.R.E, Scrap, and Layered Audit results) 用內(nèi)部和外部顧客的反饋分析了可檢測性排列Detection ratings are analyzed using external and internal customer feedback (PR/R, Warranty, SPC, Scrap reports, Quality Gate, C.A.R.E, and Layere

34、d Audit results) 評估完成后，根據(jù)新的數(shù)據(jù)列出最高的5個風險減小機會Upon completion of the review, the Top 5 (RPN) Risk Reduction Opportunities are revised based on the new data. 對最高的5個機會考慮評估所有的RPN失效模式與檢測方法The Top 5 list shall consider review all RPN failure modes for common causes and Detection methods. PFMEA評估選擇標準Selection

35、 criteria for PFMEA review:獲得的產(chǎn)品或者來源于從前供應(yīng)商的業(yè)務(wù)Product from an acquisition or business from a previous supplier未經(jīng)足夠部門間參與得到的PFMEA。 PFMEA developed without adequate cross-functional involvement 對那些有PR/R歷史的零件，顧客抱怨，擔?；騀TQ問題的PFMEA PFMEA for part(s) with history of PR/R, Customer complaints, Warranty or FTQ

36、 issues 可能性排隊發(fā)生顯著變化的Occurrence rating (FTQ, scrap, etc) have changed significantly 有最老修改日期的PFMEAPFMEA with oldest revision dates主動降低風險的要求前5位高RPN值跟蹤表(Proactive)(Example)Example: GM form1927-21(This is for reference only; check for latest revision) 被動降低風險的要求 應(yīng)利用多部門小組來解決問題Multi-disciplinary team(s) sha

37、ll be utilized for Problem Solving 小組確定每一RPN 的PFMEA嚴重性，可能性與可檢測性Team(s) identify true PFMEA Severity, Occurrence and DetectionRating for each RPN. 小組定出行動計劃來防范5個最多的故障 Team(s) shall develop an action plan to Error Proof top 5 failures. 推薦的行動是減少或防止失效模式的進步Recommended Actions are improvements that will re

38、duce or prevent the Failure Mode. 指定一名小組成員來負責確保推薦的行動被執(zhí)行A team member shall be assigned to be responsible for ensuring that the recommended action is implemented. 確立合理的目標完成日期Reasonable target completion dates shall be established.被動降低風險的要求 當防止錯誤不可行時，應(yīng)建立改進檢測的計劃Where Error Proofing is not feasible, a p

39、lan to improve detection shall be established.錯誤防止應(yīng)通過“防止錯誤確認程序”來檢驗Error proofing shall be verified per the Error Proofing Verification Process.當制定了糾正行動后，小組應(yīng)驗證新的可能性與可檢測性排序以及結(jié)果RPN When corrective actions have been established, teams shall validate the new Occurrence and Detection rankings and resultan

40、t RPN.制造場所領(lǐng)導層應(yīng)確定定期進步評估Manufacturing site leadership shall schedule regular progress reviews.風險減小總結(jié)主動地Proactive積極減小潛在質(zhì)量失效地風險Actively reduce the risk of potential quality failures .領(lǐng)導層應(yīng)評估并支持風險減小行動Site leadership shall review and support the risk reduction activities.PFMEA 應(yīng)遵照AIAG標準并相應(yīng)更新PFMEAs shall co

41、nform to AIAG standards and be updated accordingly.PFMEA最少應(yīng)每季度評估一次A minimum of one PFMEA shall be reviewed per quarter.被動Reactive多部門小組應(yīng)確定最高5個問題Multi-disciplinary teams shall identify the top 5 issues and problem solve the issues.小組應(yīng)在采取糾正措施后更新PFMEA Teams shall update PFMEAs with all corrective action

42、 measures.防錯裝置確認防錯裝置被驗證過嗎？把事情第一次做對99.9把事情第一次做對99.9意味著 每月一小時不安全的飲用水 每天有兩次不安全的著陸在OHare 機場。 每小時16,000 件郵件丟失。 每年有20,000 藥方有錯 美星期500 外科手術(shù)出錯 每天50 新出生嬰兒被醫(yī)生丟掉。 每小時22,000 支票從錯誤地帳號扣除 每人每年錯過了32,000心跳Failure mode: Burr Cause: dull tool Control: Visual InspectionSeverity: Defect caught at GM Assembly Line (scrap

43、): 5Occurrence: Supplier process PpK 1.10 4Detection: Error Proofing in process 3 RPN = 5 x 4 x 3 = 60Failure mode: Burr Cause: dull tool Control: Visual InspectionSeverity: Defect caught at GM Assembly Line (scrap): 5Occurrence: Supplier process PpK 1.10 4Detection: Error Proofing device not functi

44、oning 10 RPN = 5 x 4 x 10 = 200防錯裝置失效：帶有防錯裝置功能：放錯裝置確認的目的： 確保用于生產(chǎn)和裝配的放錯裝置的功能運行正常To ensure error proofing devices used in the manufacture and assembly of product are functioning properly.放錯裝置的確認注意: 這不是一個主要的量具。（例如：量具設(shè)定為零）This is not mastering a gage, (e.g. Setting gage to zero) 它是通過已知的好的/壞的零件來檢查的 It is

45、 sending a known good/bad part through. 裝配區(qū)域Assembly Area 制造工序Manufacturing Operations 發(fā)運/接收Shipping / Receiving 所有的工序All Operations 其他支持功能Other support functions范圍： 責任: 專人負責（一個責任人） 定義: 防錯裝置（不可制造）防止制造者或裝配不合格產(chǎn)品的設(shè)備Error Proofing Device (CAN NOT MAKE) - Devices which prevent the manufacture or assembly

46、 of non-conforming product. 錯誤檢測設(shè)備（不能通過或不能接受）防止傳遞不合格產(chǎn)品的設(shè)備（如100在線檢測設(shè)備）Devices which prevent the transfer of non-conforming product 所有可能失效，磨損，未對準或沒有校正的防止錯誤/檢測設(shè)備最起碼每天要檢驗一次。All error proofing/detection devices with the potential to fail, wear, misalign, or otherwise become out-of-adjustment shall be ver

47、ified at a minimum of once per day.要求: 防錯裝置確認ERROR PROOFING VERIFICATION 放錯裝置的主控文件應(yīng)有識別號和位置Master Document of Error Proofing devices, with identification number and location 確認頻率Verification frequency 確定標準樣件（好的/壞的）已保證不合格品被檢測出來Identify masters (Good/Bad) and defect being checked 明確定義反應(yīng)計劃如果防錯裝置失效Clearl

48、y defined reaction plan if device fails to detect當防錯裝置不能檢測出殘次，什么時候停機？品When/if shut down when device fails to detect bad part? 遏制計劃？Containment plan? (100% 檢驗Inspection, etc.) 通過防錯裝置的可疑品是否被返回？Are suspect parts rerun thru Error Proofing device? 怎樣/什么時候防錯裝置被維修？“ How/when is Error Proofing device repair

49、ed? 在防錯裝置確認之間要生產(chǎn)的產(chǎn)品的批量大小 Lot size of parts run between Error Proofing verification 用程序的歷史記錄決定驗證的頻率 History of process to determine verification frequency 程序是否穩(wěn)定 How robust is the process? 遏制可疑品的容易程度How easy is it to contain suspect product? Develop Log of Error Proof Verification failures with react

50、ion plan to non-conformities Document as Lessons Learned Method for getting information to management Determine how information is to be displayed *(Example) 分層審核 領(lǐng)導層執(zhí)行了分層審核了嗎分層審核提供了一套系統(tǒng)來：Layered Audits provide a system to: - 檢驗與備有證明文件的操作一致 - 灌輸紀律instill discipline - 促進溝通improve communication - 改善總體

51、質(zhì)量improve overall quality分層審核由制造者領(lǐng)導層掌握.質(zhì)量和其他職能部門參與并支持分層審核系統(tǒng)Layered Audits must be owned by manufacturing leadership. Quality and other functions will participate and support the Layered Audit system.制造和裝配高風險的項目應(yīng)該每班最少一次分層審核Layered Audits shall be conducted for manufacturing and assembly of high risk

52、items at a minimum of once per shift. 分層審核的頻率由生產(chǎn)量或者操作相關(guān)的風險水平?jīng)Q定Frequency of Layered Audits is based on production volume or level of risk associated with process. 分層審核補充了現(xiàn)行的控制計劃和工作指導檢查 分層審核 應(yīng)建立分層審核時要檢驗的高風險項目核對表A check list of high risk items to be verified during Layered Audits shall be established.

53、在建立核對表時要考慮的因素Elements should be considered in developing the check list. 評論由內(nèi)部審核產(chǎn)生（加工，安全，總務(wù)，常規(guī)管理等），包括在分層清單上可重復(fù)的不一致Review results from internal audits (process, safety, housekeeping, management walk through, etc) and include repetitive non- conformances on the Layered Audit checklist.(Example)Departm

54、ent 953 Sprag Sub Assembly (24201145/46)Op # 30 AssemblyMONTUESWEDTHURFRISATAre the builders checking rotation and marking parts (touch point)?Have the 8-hole sprags been inspected for presence of 8 holes and identified with orange marker?Entire DepartmentMONTUESWEDTHURFRISATAre the operator verific

55、ation sheets completed daily by all shifts ?Are the tagging procedures being followed?Are there any Temporary Alert Notices posted that have expired?Dept 953 Total Non-conforming ItemsMONTUESWEDTHURFRISATLIST ANY QUALITY OR MANUFACTURING CONCERNS ON ALL OPERATIONS. 分層審核應(yīng)核實適當?shù)馁|(zhì)量文件Layered Audits shall

56、 verify appropriate quality documentation 分層審核的結(jié)果要記錄Layered Audits results shall be recorded. 出現(xiàn)問題應(yīng)馬上解決Non-conformities shall be addressed immediately 分層審核檢測出問題的行動計劃應(yīng)記錄并隨時備用Reaction plan(s) for non-conformities detected during Layered Audits shall be documented and available for use. 糾正行動也要文件化Correc

57、tive actions shall be documented. 審核結(jié)果應(yīng)總結(jié)并交生產(chǎn)地領(lǐng)導層審閱Audit results shall be summarized and reviewed by the manufacturing site leadership. 分層審核結(jié)果合適時應(yīng)增加到“經(jīng)驗教訓”數(shù)據(jù)庫中Layered Audit results shall be added to the Lessons Learned database when appropriate. 要求 : 分層時間頻率Layered Audit frequency:- 高風險項目每班最少一次High r

58、isk items shall be verified a minimum of once per shift.- 生產(chǎn)檢查員應(yīng)(每天)確認操作員完成了質(zhì)量文件The manufacturing supervisor shall verify (daily) all quality documentation is completed by the operators. - 生產(chǎn)區(qū)經(jīng)理應(yīng)（每周）確認檢查員檢驗完成The manufacturing area manager shall verify (weekly) that supervisor verification is being c

59、ompleted. - 生產(chǎn)領(lǐng)導層應(yīng)（每月或季度）定期組織加工檢查評估Site leadership shall conduct periodic process verification assessments (monthly/quarterly). Operator SupervisorMTWTFMTWTFMTWTFManagerSite LeaderLAYERED AUDIT MATRIX (Example)(Example)(Example)C.A.R.E.質(zhì)量確認顧客滿意度總結(jié)與評估“保護顧客”.CUSTOMER ACCEPTANCE REVIEW & EVALUATION顧客滿意

60、度總結(jié)與評估 保證你的顧客無不合格和不符合產(chǎn)品Protects your customer from nonconforming product & discrepancies. 提供快速糾正行動的信息Provides information for rapid corrective action. 補充控制計劃Supplements the control plan. 應(yīng)用于與零件相關(guān)的顧客滿意項目Applies to customer satisfaction items that are part related. 工廠經(jīng)理和質(zhì)量經(jīng)理應(yīng)推動行動The Plant Manager & Qu