快速反應(yīng)程序：解決質(zhì)量問(wèn)題的反應(yīng)模式(ppt-84頁(yè))課件

1、快速反應(yīng)程序解決質(zhì)量問(wèn)題的標(biāo)準(zhǔn)化反應(yīng)模式 是一個(gè)體系運(yùn)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(wèn)題?？焖俜磻?yīng)是否存在一個(gè)每天的領(lǐng)導(dǎo)層會(huì)議？ 快速反應(yīng)會(huì)議可以是一個(gè)1020 分鐘的站立式會(huì)議，地點(diǎn)可以在車(chē)間或生產(chǎn)會(huì)議室。 過(guò)程的責(zé)任人必須來(lái)自制造部門(mén)。 在一天的開(kāi)始，質(zhì)量小組應(yīng)該識(shí)別前24小時(shí)所發(fā)生的重大質(zhì)量問(wèn)題 ，可以從一下幾個(gè)方面考慮:- 客戶關(guān)注的問(wèn)題- 供應(yīng)商所關(guān)注的問(wèn)題- 造成停線的 (內(nèi)部/客戶)問(wèn)題- 出廠審核 / 審核問(wèn)題- 其他內(nèi)部質(zhì)量問(wèn)題研討會(huì)小組首先應(yīng)該定義什么樣的質(zhì)量問(wèn)題是重大的質(zhì)量問(wèn)題。當(dāng)業(yè)務(wù)經(jīng)理不在場(chǎng)時(shí)，會(huì)發(fā)生什么呢？ 在每天的制造評(píng)估會(huì)議上領(lǐng)導(dǎo)層

2、應(yīng)該審核一下方面:- 和小組成員一起審核重大的質(zhì)量問(wèn)題- 指定相關(guān)人員負(fù)責(zé)問(wèn)題的解決- 指派下次會(huì)議報(bào)告的責(zé)任人要求 (續(xù)): 責(zé)任人應(yīng)該負(fù)責(zé)保證所有的問(wèn)題及時(shí)被解決并且滿足退出標(biāo)準(zhǔn)。 責(zé)任人的報(bào)告應(yīng)包含以下幾個(gè)方面的更新：- 快速反應(yīng)跟蹤表- 標(biāo)準(zhǔn)化操作指導(dǎo)書(shū)- 問(wèn)題解決表 - 過(guò)程失效模式分析- 控制計(jì)劃- 層級(jí)審核- 全員通告 Workforce Notification - 其他適用文件必要時(shí)在快速反應(yīng)跟蹤表上必要時(shí)，按照快速反應(yīng)跟蹤表的規(guī)定匯報(bào)給管理層 快速反應(yīng)跟蹤表 (Example)要評(píng)估的要點(diǎn):責(zé)任人退出標(biāo)準(zhǔn)全面情況優(yōu)化目視管理，將這個(gè)表格盡可能大的顯示在會(huì)議室( ex.: 4

3、 x 8 dry erase board )(舉例)領(lǐng)導(dǎo)層將展示一個(gè)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(wú)意識(shí)使用或安裝 Prevented from unintended use or installation 用統(tǒng)一的標(biāo)簽清楚識(shí)別 Clearly identified using consistent labeling 用目視管理方法建立統(tǒng)一的識(shí)別程序 (Example) 用

4、明亮色彩作為首選的識(shí)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(biāo)簽內(nèi)容IN THIS SECTION IS AT LOCAL DISCRETION標(biāo)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(biāo)簽表示廢品。 黃色標(biāo)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(jìn)一步檢查的材料綠色或其他顏色的標(biāo)簽表示產(chǎn)品是可接受的 (紅色和黃色除外). .廢品PLT002PLT003標(biāo)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(dǎo)層應(yīng)開(kāi)發(fā)

5、，組織并維護(hù)一個(gè)統(tǒng)一的體系來(lái)控制不合格品. 將不合格產(chǎn)品隔離. 隔離區(qū)域?qū)⒈粯?biāo)識(shí) - 廢料箱- 返工臺(tái)- 返工產(chǎn)品標(biāo)簽- 溢出遏制區(qū)域 遏制工作表將被完成并用于：提供一個(gè)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(diǎn)檢驗(yàn)采用:- 對(duì)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(shí)間由領(lǐng)導(dǎo)層決定 對(duì)于產(chǎn)品遏制問(wèn)題，箱子將標(biāo)識(shí)成 :- 紅色不合格產(chǎn)品 - 黃色可疑品- 綠色分界點(diǎn)后的合格產(chǎn)品 從被認(rèn)

6、可的工藝流程上拿走的產(chǎn)品返回時(shí)應(yīng)在離開(kāi)點(diǎn)或之前. 全部控制計(jì)劃都要執(zhí)行檢查和測(cè)試. 注意： 如果不可能在離開(kāi)點(diǎn)或之前返回，使用經(jīng)認(rèn)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(wèn)題要經(jīng)領(lǐng)導(dǎo)層評(píng)估. 標(biāo)準(zhǔn)化工作(方法和順序)“標(biāo) 準(zhǔn) 化 是 通 往 不 斷 改 進(jìn) 之 路.”W.E. Deming,七月 15, 1992(舉例)目的: 對(duì)所有的操作實(shí)施標(biāo)準(zhǔn)化的方法和順序。標(biāo)準(zhǔn)化工作 (方法& 順序)范圍: 裝配區(qū) 制作過(guò)程 發(fā)運(yùn) / 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(zé): 一個(gè)或兩個(gè)責(zé)任人- 制造工程人員- 生產(chǎn)經(jīng)理 精益組織.

7、 識(shí)別那些能增值的工作. 一個(gè)有效的生產(chǎn)順序. 持續(xù)改進(jìn). 在過(guò)程內(nèi)部減少變差. 減少浪費(fèi)，解決問(wèn)題和質(zhì)量控制. 審核操作員與工作指導(dǎo)書(shū)一致 層級(jí)審核. 確保操作者統(tǒng)一履行相同任務(wù)和程序.標(biāo)準(zhǔn)化的工作提供了一個(gè)基礎(chǔ): 多功能小組應(yīng)確定并列出所有要實(shí)施標(biāo)準(zhǔn)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(wèn)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(dòng)

8、Employee Flow-through多功能小組定出標(biāo)準(zhǔn)化工作的指導(dǎo)書(shū)并張貼到每一工位.新員工要被培訓(xùn)使用標(biāo)準(zhǔn)化工作（標(biāo)準(zhǔn)操作員培訓(xùn)）要求:標(biāo)準(zhǔn)化操作Standardized Operations客戶周期時(shí)間工作順序在制品的標(biāo)準(zhǔn)化標(biāo)準(zhǔn)化操作步棸TAKT TIME 生產(chǎn)出一個(gè)單位的時(shí)間Time in which a singleunit is to be produced操作工的移動(dòng)OperatorMovements相同順序相同動(dòng)作每一循環(huán)工作需要的最小庫(kù)存Minimum stock necessaryto do work in the samesequence with the same

9、movements, every cycle列出客戶周期時(shí)間的理由: 使領(lǐng)導(dǎo)層確信業(yè)務(wù)如批準(zhǔn)的那樣在運(yùn)轉(zhuǎn)Assures leadership that operation is running as approved 可減少生產(chǎn)過(guò)剩 Overproduction can be reduced 改進(jìn)生產(chǎn)調(diào)度 Improves production scheduling 操作員可介入到?jīng)Q策過(guò)程O(píng)perator involved in decision making process 設(shè)備顯示出磨損跡象時(shí)操作員能知道Operator knows if equipment is showing sign

10、s of wear. 安排維護(hù)與修理時(shí)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(shí)施分層審核而安排時(shí)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 sam

11、e way every time 減少組分被遺漏的風(fēng)險(xiǎn)Reduces the risk of components being left out 沒(méi)有操作被遺漏或忽略No operations are skipped or omitted 提醒進(jìn)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(jìn)Process improvements are easily identified 新手培訓(xùn)更一致Training new operators is more consistent顯示標(biāo)準(zhǔn)工作程序的原因: 操作員控制再填充箱柜的頻

12、率Operator controls frequency of refilling bins 警告材料管理員短缺或過(guò)量庫(kù)存Alert material handler of shortages or excess inventory 減小由于原料儲(chǔ)運(yùn)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(shí)間Allows material handler to manage their time Standardized Operations Worksheet And Layo

13、ut標(biāo)準(zhǔn)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(biāo)準(zhǔn)化的操作工作表和計(jì)劃應(yīng)包括Standardized Operation

14、s Worksheets And Layout shall include:- 工作原理Work Elements- 操作員動(dòng)作Operator Movement- 操作周期時(shí)間Operation Cycle Time(Example)(Example)要求（續(xù)）: 標(biāo)準(zhǔn)化的工作說(shuō)明書(shū)應(yīng)通過(guò)分層審核檢驗(yàn)任何操作在持續(xù)12個(gè)月里由于缺乏堅(jiān)持標(biāo)準(zhǔn)化的工作說(shuō)明出現(xiàn)的不一致Standardized work instructions shall be verified through Layered Audits for any operation which shipped a non-confor

15、mance 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(jìn)行的質(zhì)量成績(jī)對(duì)標(biāo)準(zhǔn)化的工作說(shuō)明書(shū)做持續(xù)的改進(jìn)Multi-disciplinary team(s) shall continuously develop/improve standardized work instructions based on ongoing quality performance.操作員培訓(xùn)的標(biāo)準(zhǔn)化操作員的培訓(xùn)是否經(jīng)過(guò)驗(yàn)證并記錄在案？ 操作員標(biāo)準(zhǔn)化培訓(xùn)要求Stand

16、ardized Operator TrainingRequirements多功能小組決定每一道工序至少的培訓(xùn)內(nèi)容A cross functional team shall define the minimum training content for each operation.此組織決定誰(shuí)來(lái)實(shí)施培訓(xùn)The organization shall identify who will conduct training.培訓(xùn)員監(jiān)督新操作員的行動(dòng)，必要時(shí)重新培訓(xùn)以確保標(biāo)準(zhǔn)工作指導(dǎo)被遵循Trainers shall monitor new operators activities and retrai

17、n if necessary to assure Standard Work Instructions are being followed.培訓(xùn)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(xùn)者應(yīng)指導(dǎo)操作員使用標(biāo)準(zhǔn)操作員培訓(xùn)表Trainers shall instruct operators u

18、sing the standard operator training sheet. (Example)標(biāo)準(zhǔn)化操作培訓(xùn)記錄(Example)Application: 運(yùn)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(biāo)準(zhǔn)化的工作指導(dǎo)Standardized work / job instructions要填充的質(zhì)量記錄Quality records to be filled out (eg. Check sheets

19、)示范操作和問(wèn)題回答Demonstrate the operation and answer questions示范測(cè)量和回答問(wèn)題Demonstrate gaging and answer questions新員工是否進(jìn)行操作并回答問(wèn)題Have new employee run operation and answer questions講授過(guò)去的問(wèn)題Teach past problems (eg. FMEA, Top Problems List)檢驗(yàn)首次生產(chǎn)，培訓(xùn)作為必須Verify first units produced, coach as needed換班時(shí)報(bào)告，重新檢驗(yàn)標(biāo)準(zhǔn)化的工作與

20、產(chǎn)品質(zhì)量Return within the shift, verify std work & product quality again大約1天報(bào)告，重新檢驗(yàn)標(biāo)準(zhǔn)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(bào)潛在缺陷Notify downstream operations of potential defects雇員簽名Employee Signature _ 培訓(xùn)員簽名Trainer Signature _Operation Name and # _零件（產(chǎn)品）功能Part (p

21、roduct) function安全/設(shè)備操作 Safety/ Equipment Operation(Example)標(biāo)準(zhǔn)化的操作培訓(xùn)記錄 標(biāo)準(zhǔn)化操作員培訓(xùn)要求操作員跟蹤表應(yīng)張貼在每一操作位置通過(guò)分層審核檢驗(yàn)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(gè)月內(nèi)沒(méi)有

22、經(jīng)過(guò)培訓(xùn)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(xùn)者應(yīng)定期檢驗(yàn)質(zhì)量以確保達(dá)到所有的標(biāo)準(zhǔn)。最起碼培訓(xùn)者應(yīng)在一個(gè)換班與一天內(nèi)報(bào)告。The trainer shall verify quality at a frequency determined necessary to assure all standards are met. At a minimum the trainer shall return wi

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

24、n Rev. Date標(biāo)準(zhǔn)化的培訓(xùn)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(xùn)負(fù)責(zé)人。保證操作員培訓(xùn)通過(guò)“操作員培訓(xùn)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(guò)分級(jí)審核檢驗(yàn) post operator Tracking Sheets at each operation, and verify through Layered Audits.schedule refresher training for assigned ope

25、rators at local site discretion.降低風(fēng)險(xiǎn)的程序積極主動(dòng)RPN 降低程序:降低潛在質(zhì)量失效被動(dòng)對(duì)已發(fā)生的質(zhì)量失效建立防錯(cuò)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(shí)別和排除方法A structured procedure for identifying and eliminating process related failure modes.識(shí)別每一個(gè)過(guò)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(dá)到要求的情形 Ways that a proces

26、s may fail to meet requirements內(nèi)在/外部消費(fèi)者的嚴(yán)重度Consequences to the internal / external customer (嚴(yán)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(dāng)前控制的效果Effectiveness of current controls (預(yù)防核可探測(cè)度)原因和結(jié)果的排隊(duì)Ranking of causes and effects (風(fēng)險(xiǎn)順序數(shù))會(huì)出現(xiàn)什么問(wèn)題What can go wrong?它是怎樣影響客戶的How does it af

27、fect customer?多久發(fā)生一次How often does this cause happen?如果問(wèn)題發(fā)生，有多大可能我們會(huì)注意道它How likely are we to notice if this happens?風(fēng)險(xiǎn)程度有多高How high is the risk?PFMEA: 過(guò)程失效模式及影響Process Failure Mode & Effects (example)(AIAG PFMEA Third Edition)嚴(yán)重度分級(jí)Severity Rankings(AIAG PFMEA Third Edition)發(fā)生頻率分級(jí)Occurrence Ranking(A

28、IAG PFMEA Third Edition)可探測(cè)性分級(jí)Detection Rankings(AIAG PFMEA Third Edition) 風(fēng)險(xiǎn)順序數(shù)是嚴(yán)重度，發(fā)生頻率與可探測(cè)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(yán)重度Severity x 發(fā)生頻率Occurrence x 覺(jué)察可能Detection = RPN風(fēng)險(xiǎn)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

29、能如接受檢查、材料處理、分類(lèi)與發(fā)運(yùn)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(dòng)態(tài)文件） 所有的生產(chǎn)線/產(chǎn)品號(hào)都有相應(yīng)的PFMEA 包含所有過(guò)程和工序 應(yīng)用于持續(xù)改

30、進(jìn) 準(zhǔn)確定義嚴(yán)重度/頻率/可探測(cè)度的等級(jí)主動(dòng)降低風(fēng)險(xiǎn)的要求Site Leadership 領(lǐng)導(dǎo)層最起碼每年一次評(píng)估PFMEA培訓(xùn)需要Leadership should review the need for PFMEA training at least once per year. 領(lǐng)導(dǎo)層應(yīng)支持RPN減少活動(dòng)并提供必需的資源Leadership shall support RPN reduction activities and provide necessary resources. 領(lǐng)導(dǎo)層應(yīng)評(píng)估RPN減少跟蹤表RPN reduction tracking charts shall be

31、reviewed by leadership. 領(lǐng)導(dǎo)層應(yīng)確保PFMEA的準(zhǔn)備與評(píng)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(dòng)降低風(fēng)險(xiǎn)的要求主動(dòng)降低風(fēng)險(xiǎn)的要求 根據(jù)過(guò)程的穩(wěn)定性，顧客的反饋等，供應(yīng)商領(lǐng)導(dǎo)層決定PFMEA評(píng)估的頻率（如每月一次）Based process stability, customer feedback, etc and supplier leade

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

33、and accurate.通過(guò)數(shù)據(jù)分析了可能性排隊(duì)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(cè)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 Lay

34、ered Audit results) 評(píng)估完成后，根據(jù)新的數(shù)據(jù)列出最高的5個(gè)風(fēng)險(xiǎn)減小機(jī)會(huì)Upon completion of the review, the Top 5 (RPN) Risk Reduction Opportunities are revised based on the new data. 對(duì)最高的5個(gè)機(jī)會(huì)考慮評(píng)估所有的RPN失效模式與檢測(cè)方法The Top 5 list shall consider review all RPN failure modes for common causes and Detection methods. PFMEA評(píng)估選擇標(biāo)準(zhǔn)Select

35、ion criteria for PFMEA review:獲得的產(chǎn)品或者來(lái)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(mén)間參與得到的PFMEA。 PFMEA developed without adequate cross-functional involvement 對(duì)那些有PR/R歷史的零件，顧客抱怨，擔(dān)保或FTQ問(wèn)題的PFMEA PFMEA for part(s) with history of PR/R, Customer complaints, Warranty or

36、FTQ issues 可能性排隊(duì)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(dòng)降低風(fēng)險(xiǎn)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(dòng)降低風(fēng)險(xiǎn)的要求 應(yīng)利用多部門(mén)小組來(lái)解決問(wèn)題Multi-disciplinary team(s)

37、shall be utilized for Problem Solving 小組確定每一RPN 的PFMEA嚴(yán)重性，可能性與可檢測(cè)性Team(s) identify true PFMEA Severity, Occurrence and DetectionRating for each RPN. 小組定出行動(dòng)計(jì)劃來(lái)防范5個(gè)最多的故障 Team(s) shall develop an action plan to Error Proof top 5 failures. 推薦的行動(dòng)是減少或防止失效模式的進(jìn)步Recommended Actions are improvements that will

38、 reduce or prevent the Failure Mode. 指定一名小組成員來(lái)負(fù)責(zé)確保推薦的行動(dòng)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(biāo)完成日期Reasonable target completion dates shall be established.被動(dòng)降低風(fēng)險(xiǎn)的要求 當(dāng)防止錯(cuò)誤不可行時(shí)，應(yīng)建立改進(jìn)檢測(cè)的計(jì)劃Where Error Proofing is not feasible,

39、a plan to improve detection shall be established.錯(cuò)誤防止應(yīng)通過(guò)“防止錯(cuò)誤確認(rèn)程序”來(lái)檢驗(yàn)Error proofing shall be verified per the Error Proofing Verification Process.當(dāng)制定了糾正行動(dòng)后，小組應(yīng)驗(yàn)證新的可能性與可檢測(cè)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 resul

40、tant RPN.制造場(chǎng)所領(lǐng)導(dǎo)層應(yīng)確定定期進(jìn)步評(píng)估Manufacturing site leadership shall schedule regular progress reviews.風(fēng)險(xiǎn)減小總結(jié)主動(dòng)地Proactive積極減小潛在質(zhì)量失效地風(fēng)險(xiǎn)Actively reduce the risk of potential quality failures .領(lǐng)導(dǎo)層應(yīng)評(píng)估并支持風(fēng)險(xiǎn)減小行動(dòng)Site leadership shall review and support the risk reduction activities.PFMEA 應(yīng)遵照AIAG標(biāo)準(zhǔn)并相應(yīng)更新PFMEAs shall

41、 conform to AIAG standards and be updated accordingly.PFMEA最少應(yīng)每季度評(píng)估一次A minimum of one PFMEA shall be reviewed per quarter.被動(dòng)Reactive多部門(mén)小組應(yīng)確定最高5個(gè)問(wèn)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 act

42、ion measures.防錯(cuò)裝置確認(rèn)防錯(cuò)裝置被驗(yàn)證過(guò)嗎？把事情第一次做對(duì)99.9把事情第一次做對(duì)99.9意味著 每月一小時(shí)不安全的飲用水 每天有兩次不安全的著陸在OHare 機(jī)場(chǎng)。 每小時(shí)16,000 件郵件丟失。 每年有20,000 藥方有錯(cuò) 美星期500 外科手術(shù)出錯(cuò) 每天50 新出生嬰兒被醫(yī)生丟掉。 每小時(shí)22,000 支票從錯(cuò)誤地帳號(hào)扣除 每人每年錯(cuò)過(guò)了32,000心跳Failure mode: Burr Cause: dull tool Control: Visual InspectionSeverity: Defect caught at GM Assembly Line (sc

43、rap): 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 fun

44、ctioning 10 RPN = 5 x 4 x 10 = 200防錯(cuò)裝置失效：帶有防錯(cuò)裝置功能：放錯(cuò)裝置確認(rèn)的目的： 確保用于生產(chǎn)和裝配的放錯(cuò)裝置的功能運(yùn)行正常To ensure error proofing devices used in the manufacture and assembly of product are functioning properly.放錯(cuò)裝置的確認(rèn)注意: 這不是一個(gè)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(guò)已知的好的/壞的零件來(lái)檢查的 It

45、 is sending a known good/bad part through. 裝配區(qū)域Assembly Area 制造工序Manufacturing Operations 發(fā)運(yùn)/接收Shipping / Receiving 所有的工序All Operations 其他支持功能Other support functions范圍： 責(zé)任: 專(zhuān)人負(fù)責(zé)（一個(gè)責(zé)任人） 定義: 防錯(cuò)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 assem

46、bly of non-conforming product. 錯(cuò)誤檢測(cè)設(shè)備（不能通過(guò)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(cè)設(shè)備）Devices which prevent the transfer of non-conforming product 所有可能失效，磨損，未對(duì)準(zhǔn)或沒(méi)有校正的防止錯(cuò)誤/檢測(cè)設(shè)備最起碼每天要檢驗(yàn)一次。All error proofing/detection devices with the potential to fail, wear, misalign, or otherwise become out-of-adjustment shall be

47、verified at a minimum of once per day.要求: 防錯(cuò)裝置確認(rèn)ERROR PROOFING VERIFICATION 放錯(cuò)裝置的主控文件應(yīng)有識(shí)別號(hào)和位置Master Document of Error Proofing devices, with identification number and location 確認(rèn)頻率Verification frequency 確定標(biāo)準(zhǔn)樣件（好的/壞的）已保證不合格品被檢測(cè)出來(lái)Identify masters (Good/Bad) and defect being checked 明確定義反應(yīng)計(jì)劃如果防錯(cuò)裝置失效Cle

48、arly defined reaction plan if device fails to detect當(dāng)防錯(cuò)裝置不能檢測(cè)出殘次，什么時(shí)候停機(jī)？品When/if shut down when device fails to detect bad part? 遏制計(jì)劃？Containment plan? (100% 檢驗(yàn)Inspection, etc.) 通過(guò)防錯(cuò)裝置的可疑品是否被返回？Are suspect parts rerun thru Error Proofing device? 怎樣/什么時(shí)候防錯(cuò)裝置被維修？“ How/when is Error Proofing device rep

49、aired? 在防錯(cuò)裝置確認(rèn)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(yàn)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 re

50、action 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(dǎo)層執(zhí)行了分層審核了嗎分層審核提供了一套系統(tǒng)來(lái)：Layered Audits provide a system to: - 檢驗(yàn)與備有證明文件的操作一致 - 灌輸紀(jì)律instill discipline - 促進(jìn)溝通improve communication - 改

51、善總體質(zhì)量improve overall quality分層審核由制造者領(lǐng)導(dǎo)層掌握.質(zhì)量和其他職能部門(mén)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(fēng)險(xiǎn)的項(xiàng)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 ri

52、sk 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(fēng)險(xiǎn)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(bǔ)充了現(xiàn)行的控制計(jì)劃和工作指導(dǎo)檢查 分層審核 應(yīng)建立分層審核時(shí)要檢驗(yàn)的高風(fēng)險(xiǎn)項(xiàng)目核對(duì)表A check list of high risk items to be verified during Layered Audits shall be establishe

53、d. 在建立核對(duì)表時(shí)要考慮的因素Elements should be considered in developing the check list. 評(píng)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)Depa

54、rtment 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 veri

55、fication 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(shí)適當(dāng)?shù)馁|(zhì)量文件Layered Audits sh

56、all 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(wèn)題應(yīng)馬上解決Non-conformities shall be addressed immediately 分層審核檢測(cè)出問(wèn)題的行動(dòng)計(jì)劃應(yīng)記錄并隨時(shí)備用Reaction plan(s) for non-conformities detected during Layered Audits shall be documented and available for use. 糾正行動(dòng)也要文件化Cor

57、rective actions shall be documented. 審核結(jié)果應(yīng)總結(jié)并交生產(chǎn)地領(lǐng)導(dǎo)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(shí)應(yīng)增加到“經(jīng)驗(yàn)教訓(xùn)”數(shù)據(jù)庫(kù)中Layered Audit results shall be added to the Lessons Learned database when appropriate. 要求 : 分層時(shí)間頻率Layered Audit frequency:- 高風(fēng)險(xiǎn)項(xiàng)目每班最少一次Hig

58、h risk items shall be verified a minimum of once per shift.- 生產(chǎn)檢查員應(yīng)(每天)確認(rèn)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(rèn)檢查員檢驗(yàn)完成The manufacturing area manager shall verify (weekly) that supervisor verification is bein

59、g completed. - 生產(chǎn)領(lǐng)導(dǎo)層應(yīng)（每月或季度）定期組織加工檢查評(píng)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(rèn)顧客滿意度總結(jié)與評(píng)估“保護(hù)顧客”C.A.R.E.CUSTOMER ACCEPTANCE REVIEW & EVAL

60、UATION顧客滿意度總結(jié)與評(píng)估 保證你的顧客無(wú)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(dòng)的信息Provides information for rapid corrective action. 補(bǔ)充控制計(jì)劃Supplements the control plan. 應(yīng)用于與零件相關(guān)的顧客滿意項(xiàng)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(dòng)行動(dòng)The Plant Ma