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1、Vishay Customer Corrective Action Request (CAR) GuidelinesVishay客户纠正措施要求CAR应用指南5/30/2002 Rev. Orig8D TrainingWhat is a CAR/ 8D?何谓CAR/8D ?A CAR/8D Report is a method to document, communicate, track and drive resolutions for quality issues.CAR/8D是针对品质问题而进行文件化、沟通、追踪及解决问题的方法。An 8D report is Ford Motor C
2、ompanys format for problem solving. It is the preferred method used throughout our industry.CAR/8D报告是福特公司解决问题的格式。它是我们所有行业首选的解决问题的方法。5/30/2002 Rev. Orig8D TrainingImmediate Containment. 采取迅速的围堵措施(短期对策)Clear identification of Root Cause. 真正识别问题产生的根本原因(真因)Robust Corrective Actions. 充分的纠正措施Verified Corr
3、ective Actions. 验证纠正措施System fixes. 系统化(即纠正措施标准化或文件化)100% On-time response. 100%准时反应(即及时解决问题,准时回复客户)Eliminate the problems the first time. 做到第一次就消除问题所在Prevention of future problems. 实现潜在问题的预防CUSTOMER 8D EXPECTATION客户应用8D的期望5/30/2002 Rev. Orig8D TrainingCAR/8D Report Problems完成CAR/8D报告存在的问题Not identi
4、fying the true processes, escape, and system root causes. 没有识别出过程、流出(逃脱)及系统的根本原因(真因)Not implementing system corrective actions. 没有实施系统性纠正措施Not properly containing entire pipeline of product. 没有针对产品的所有流程采取正确的围堵措施Unclear or ambiguous wording. 对问题采取的不明确或模棱两可的描述Not meeting customer expectations regardin
5、g content and cycle time. 不符合客户关于内容及回复时间的要求5/30/2002 Rev. Orig8D TrainingCAR/8D RequirementsCAR/8D的要求All corrective action requests must be completed using an 8D report (unless a different method is required by Customer). 所有的纠正措施要求必须采用8D报告形式(除非客户要求采用不同的方法Must use Corporate format. 必须采用Vishay公司的格式Mus
6、t use 8D checklist as a guideline in completing the 8Ds. 在完成报告的过程中必须采用8D检查表进行检查5/30/2002 Rev. Orig8D Training8 Disciplines to Problem Solving解决问题的8个准则D1 Establish a Team 组建问题解决小组D2 Describe the Problem 描述问题D3 Contain the problem 采取围堵措施(即短期对策)D4 Identify the root causes 识别/确认根本原因(真因)D5 Corrective Act
7、ions 确认纠正措施D6 Implement Corrective Actions 实施纠正措施(即长期对策)D7 Prevent Recurrence 防止再发D8 Congratulate the Team 小组庆祝5/30/2002 Rev. Orig8D TrainingD1 Establish TeamD1 组建问题解决小组Establish Cross Functional Team. 建立跨功能小组Identify a Champion. 确定小组长Members should be from all affected areas, not just quality! i.e.
8、 Sales, Logistics, Marketing, Engineering, Line Operators, Production Mgmt., etc 小组成员应来自于所有被涉及区域,并非只是质量部!如销售、物流、市场、工程、生产线操作工、生产管理等等The Team should ask themselves do they have the correct skill mix to solve the problem? 小组应询问自己是否具有解决问题所必需的能力?5/30/2002 Rev. Orig8D TrainingD2 Describe the ProblemD2 描述问
9、题Clearly Identify and Define the Problem. 明确识别和定义问题In many cases Problems are ambiguous or imprecise. 在许多案例中,问题是模棱两可或不明确的Clarity ensures that everyone is trying to solve the same Problem. 明确问题可确保任何人将尽力去解决问题5/30/2002 Rev. Orig8D TrainingD2 Describe the Problem ElementsD2 描述问题要素What is the Problem? De
10、scribe the failure mode. 问题是什么? 描述失效模式Where was it detected? 问题是在哪里被发现?When was it detected? 问题是什么时候被发现?What lots/date codes are affected? 被影响的批次/日期码是那些?How many pieces are affected? 被影响的数量是多少?Is the Customer information included? 是否包含客户信息?5/30/2002 Rev. Orig8D TrainingD2 Describe the Problem Exampl
11、esD2 描述问题案例Poor Problem Description 差劲的问题描述“Customer received wrong part.”客户接收到错误零件Good Problem Description 完美的问题描述“Customer received incorrect value CRCW-0603 resistors on 4/1/02. Customer P.O. 441960 (Vishay P.O. X765644-30) specified CRCW-0603, 8.2K ohm and received CRCW-0603, 82K ohm parts.”客户在4
12、/1/02接收到阻值错误的CRCW-63电阻。客户订单号码441960( Vishay订单号码X765644-30)指定的CRCW-63电阻的阻值为8.2欧姆,而收到的CRCW-63电阻的阻值为82欧姆。5/30/2002 Rev. Orig8D TrainingD3 ContainmentD3 围堵措施(短期对策)Containment is similar to quarantine. Quarantine does not cure a disease, but it keeps it from spreading. 围堵相似于病人隔离。隔离虽不能医好疾病,但可以防止疾病的传播Find
13、and segregate nonconforming products to prevent shipment to Customer. 查找和隔离不良品,防止发往客户Shutdown processes/equipment that is producing bad product. 停止正在制造不良的加工或装配Make sure containment actions are effective. 确保围堵措施是有效的5/30/2002 Rev. Orig8D TrainingD3 Containment ElementsD3 围堵措施要素Has an effective contain
14、ment method been identified and documented? 是否有有效的围堵方法已经被确定和文件化?Have dates (or date codes) for temporary containment actions been identified? 是否已经确定了临时围堵措施实施的日期(日期码)?Have actions been verified with before and after data? 是否已经验证了围堵措施实施前后的效果?Has the entire pipeline been contained (production, warehous
15、e, distributors)? 是否对产品的所有流程采取了围堵措施(如生产线、仓库及发 货员)?Has detailed instructions on containment been issued to people responsible for containment? 是否给负责实施围堵措施的人员发放了详细的围堵作业指导书?5/30/2002 Rev. Orig8D TrainingD3 Containment ExampleD3 围堵措施案例Poor Containment 差劲的围堵措施“Operator was alerted of the failure.”让操作工提防/
16、注意此不良Good Containment 完美的围堵措施“Production and warehouse material was inspected on 4/1/02 by J. Smith (quality assurance personnel) and there were 0 lots out of 320 containing mixed devices.”J. Smith(质量保证人员)于4/1/02检查了生产线及仓库材料5/30/2002 Rev. Orig8D TrainingD4 Root CauseD4 根本原因(真因)Root cause is the disea
17、se (starting point) that sets in motion the cause and effect chain that creates the problem or problems. 根本原因是产生问题或问题群的原因和影响开始发作的病 因(发作点)Be wary of selecting symptoms instead of root causes If you fix a symptom you wont solve the problem. 必须提防以症状代替病因,如果你仅仅关注一个症状,你将不能 解决问题Poor root cause selection re
18、sults in poor corrective actions. 选择不正确的根本原因将导致不正确的纠正措施Use tools such as 5 Why analysis to ensure that the root cause has been identified. 应用象“5个为什么”分析法,确保根本原因被识别和确定5/30/2002 Rev. Orig8D TrainingD4 Root Cause ElementsD4 根本原因要素Has the process root cause been identified and established? 制程根本原因是否已经被识别和
19、确定?Has the escape root cause been identified and established? 流出(逃脱)根本原因是否已经被识别和确定?Has the system root cause been identified and established? 系统根本原因是否被识别和确定?Do the three root causes explain all we know about the problem (timing, failure mode, failure amount, etc)? 三种根本原因是否可以解说我们所知道的问题所有方面(如时 间、失效模式、
20、失效数量等等) ?Was the root cause analysis performed using the 5 why technique? 根本原因分析是否使用了“5个为什么”方法?5/30/2002 Rev. Orig8D TrainingD4 Root Cause ExamplesD4 根本原因案例Poor Root Cause Statement 差劲的根本原因“Operator placed wrong label on Package. It was an Operator Error.”操作工在包装箱上贴错了标签,是操作工的错。 Good Root Cause Statem
21、ent 完美的根本原因“Process Root Cause: An incorrect label was placed on the package because the current system allows for multiple lots to be processed (batch printing) at one workstation.”制程根本原因:目前的系统允许在同一个岗位加工种类不同的批次,导 致错误的标签被贴在包装箱上“Escape Root Cause: The mis-labeled product escaped because there was no
22、verification step at or after the label process. ” 流出根本原因:贴错标签的产品流出是因为在该岗位或后续过程没有标 签验证步骤5/30/2002 Rev. Orig8D TrainingD5 Corrective ActionsD5 纠正措施Corrective actions should fix the disease or root cause. 纠正措施必须是针对病因或根本原因(真因)Corrective actions should address process, escape, and system root causes. 纠正
23、措施必须致力于制程、流出(逃脱)及系统的根本原因 (真因)Negative effects of corrective actions should be considered. 必须考虑纠正措施带来的负面影响(即边界效应)Retraining of operators is not a corrective action. 操作工的再教育不属于纠正措施范畴Increased inspection is not a corrective action. 增加检查(人员、数量、频次等)也不属于纠正措施范畴5/30/2002 Rev. Orig8D TrainingD5 Corrective Ac
24、tions ElementsD5 纠正措施要素Have primary and alternative corrective actions been identified? 是否已识别和确定首选及多选的纠正措施Do corrective actions address process, escape, and system root causes? 纠正措施是否是针对制程、流出(逃脱)及系统的根 本原因Have negative effects of corrective actions been considered? 是否考虑了纠正措施的负面影响(即边界效应)5/30/2002 Rev.
25、 Orig8D TrainingD5 Corrective Action ExamplesD5 纠正措施案例Poor Corrective Action 差劲的纠正措施“Re-train operator.” 操作工再培训Good Corrective Action 完美的纠正措施“Process Corrective Action: Change workflow to a serial process whereby only one lot is at the printing station at all times. This will eliminate the chance of
26、 mixing the product labels.” 制程纠正措施:变更流程,在任何时间标签印刷岗位只加工单一批次“Escape Corrective Action: Implement a barcode verification step to ensure that customer label matches the factory label.”流出(逃脱)纠正措施:实施标签验证步骤,确保工厂标签和客户 标签一致5/30/2002 Rev. Orig8D TrainingD6 Implement Corrective ActionsD6 实施纠正措施(长期对策)Step wher
27、e we monitor /validate that the corrective actions have eliminated the root cause(s). 确定我们监控/验证纠正措施是否已经消除了根本原因的步骤Dates for the start and completion of the corrective action should be identified along with the responsible person. 和纠正措施实施责任人一起确定纠正措施开始实施和完成的日期5/30/2002 Rev. Orig8D TrainingD6 Implement
28、Corrective Actions Elements纠正措施实施要素Have corrective action dates along with responsible individual been identified? 是否已经确定纠正措施实施日期和责任人?Have corrective actions been validated to eliminate root cause(s)? 对纠正挫伤是否进行了验证,它能否消除根本原因?5/30/2002 Rev. Orig8D TrainingD6 Implement Corrective Actions ExamplesD6 纠正措
29、施实施案例Poor Corrective Action 差劲的纠正措施“Complete.” 已完成Good Corrective Action 完美的纠正措施“Corrective actions stated in D5 were completed on 4/1/02 by J. Smith. Post labeling inspection has discovered 0 failures out of 400 lots inspected as of 5/1/02.” J. Smith已于4/1/02完成了D%中描述的纠正措施。 5/1/02在标签检查岗位共检查了400个批次,没有
30、发现一批标签不良5/30/2002 Rev. Orig8D TrainingD7 Prevent RecurrenceD7 防止再发Prevent the problem from returning by addressing production, business, management, or engineering processes. 通过向生产、业务、管理层、工程传达,以防止问题再发5/30/2002 Rev. Orig8D TrainingD7 Prevent Recurrence ElementsD7 防止再发要素Do preventive actions address b
31、asic system issues? 预防措施阐述是否基于基本的系统问题Have FMEAs, control plans, and/or procedures been updated to ensure that the systems will prevent issues from re-occurring? FMEA、控制计划及/或程序是否已经被更新,以确保系统可以防止问题再发Have preventive actions been agreed upon by all affected areas? 预防措施是否已经征得被影响区域的认可Do unfinished preventi
32、ve actions have a champion and a projected completion date? 未完成预防措施是否确定了组长和其完成日期 5/30/2002 Rev. Orig8D TrainingD7 Prevent Recurrence ExamplesD7 防止再发案例Poor Preventive Action 差劲的预防措施“Same as corrective actions.” 预防措施同于纠正措施Good Preventive Actions 完美的预防措施“Work instruction and control plan have been chan
33、ged on 4/1/02 to eliminate batch processing and to add barcode verification processes” 作业指导书及控制计划已于4/1/02进行变更,以消除批次处理问题及增加标签验证过程“Corrective and Preventive actions were also applied to Vishays sister factories in China on 4/1/02.”纠正/预防措施已于4/1/02应用于Vishay在中国的兄弟工厂“Audit checklist was modified on 4/1/02
34、 to include monthly checks to ensure single lot processing.”检查表已于4/1/02修订,包括月检以确保单一批次被加工5/30/2002 Rev. Orig8D TrainingD8 Congratulate TeamD8 小组庆祝Varies by facility but most often overlooked. 5/30/2002 Rev. Orig8D TrainingOther Comments其他内容8D should supply facts not emotions. 8D应该提供事实,不应带有感情色彩Avoid u
35、sing internal acronyms. 避免使用公司内部缩写Be complete in your descriptions. 叙述应该完整It is our responsibility to fix Vishay problems even if we do not have traceability information. 即使没有可追溯的信息,但关注Vishay问题是我们的责任5/30/2002 Rev. Orig8D Training8D ExampleHeart Inc, a manufacturer of Heart defibulators, returned 25
36、shorted parts with multiple date codes on 5/1/02. Heart stated that the 25 parts failed at there final test. Hearts failure rate is 10 PPM. They expressed concern that failed defibulators might reach their customers.Internal analysis by Vishay indicates that the 25 parts are indeed shorted and they
37、are not the device type (PN# V123) that Vishay sells to Heart Inc. In fact, the 25 parts are a mixture of different Vishay devices spanning the last 3 months of production (February, March, and April). All returned devices had a lower power rating than what is supplied to Heart, which is why they sh
38、orted in Hearts application. Additional analysis, points to the fact that the parts were mixed at marking. The marking equipment has a known defect in which the last few parts might get stuck in the track due to random but frequent sticking of the pushpin mechanism when the bowl feeder becomes empty
39、. To combat this issue, the engineer during the initial discovery of the issue instructed the operators to inspect the track prior to starting a new lot. In the event that parts were left over the operator was to remove the devices and call the technician to repair the pushpin. In addition to the ch
40、ange in procedure, production implemented a sample outgoing electrical test (200 pieces per 20,000 piece lot) to eliminate mixed lots. The operator on the marking equipment was new (approximately working for Vishay for 3 months) and was not performing the inspection as required by the procedure. 5/3
41、0/2002 Rev. Orig8D Training8D Example 8D案例 D1 Establish Team D1建立小组NameFunctionChampionJ. SmithProduct Eng ManagerTeam LeaderJ. DoeQuality EngineerMembersR. NeilProduction SupervisorB. DellProduction EngineerV. ChambersLogistic SupervisorA. MayMaintenance EngineerN. PhillipsTraining SupervisorS. Rob
42、inSales5/30/2002 Rev. Orig8D Training8D Example 8D案例 D2 Describe Problem D2 描述问题Heart Inc. returned 25 V123 parts on 5/1/02 with the following datecodes that failed short at their final test. Heart 公司在 5/1/02返回25个V123产品,产品日期码如下,这些产品是其产品终检时发现短路的# of Parts Date Code 10 0202 10 0203 5 0204The estimated
43、 failure rate is 10PPM and the customer is concerned about field reliability.估计失效率为10PPM,而且客户非常担心已流入市场5/30/2002 Rev. Orig8D Training8D Example 8D案例D3 Containment Actions D3 围堵措施All product in production and in Vishays warehouses was quarantined (by V. Chambers on 5/2/02) and 100% electrically tested
44、 (by B. Dell on 5/4/02) to eliminate the mixed product. 12 mixed parts were removed out of 60,000 parts tested. All retested lots will be marked with a “green” sticker to identify that they have been retested.所有在线及在库品全部隔离( V. Chambers 已于5/2/02完成),并进行100%电性测试以消除混入产品( B. Dell已于5/4/02完成) ,从60,000个中剔除出1
45、2个异类产品。所有重测的产品批均用“绿色”标签标识以示重测。5/30/2002 Rev. Orig8D Training8D Example 8D案例 D4 Process Root Cause D4制程根本原因Problem: Shorted Parts问题:短路Why? Wrong parts were sent to Customer and the parts were underrated for the application. 为什么:错误的元件发给客户及其用途被低估Why? Residual parts were left in the marking equipment ca
46、using the subsequent lot to contain mixed parts.为什么:残留的元件被遗留在打标机上导致其混入后续的批次Why? The push pin failed to clear the residual parts.为什么:推针失效而无法清除残留元件5/30/2002 Rev. Orig8D Training8D Example 8D案例 D4 System Root Cause D4 系统根本原因Problem: Shorted Parts问题描述:短路Why? Wrong parts were sent to Customer and the par
47、ts were underrated for the App. 为什么:错误的元件发给客户及其用途被低估Why? Residual parts were left in the marking equipment causing the subsequent lot to contain mixed parts.为什么:残留的元件被遗留在打标机上导致其混入后续的批次Why? The push pin failed to clear the residual parts.为什么:推针失效而无法清除残留元件Why? The actuators on the push pin are old and
48、 need to be replaced.为什么:推针执行器老化而需要更换Why? We do not have a detail preventive maintenance plan for replacement of worn-out /old equipment.为什么:我们没有一个详细的针对替换破损/老化设备的维护计划5/30/2002 Rev. Orig8D Training8D Example 8D案例 D4 Escape Root Cause D4 流出根本原因Problem: Mixed Parts Escaped to Customer问题描述:混入产品流到客户Why?
49、Sample test post marking will not always detect PPM issues.为什么:抽样检查岗位无法发现PPM级缺陷Why? Sample size is too small. 为什么:抽样量非常少5/30/2002 Rev. Orig8D Training8D Example 8D案例D5 Root Cause D5 根本原因Analysis: Vishay verified that the parts are shorted. It was determined that the shorted parts were mixed devices
50、that had lower power ratings than the ones supplied to Heart. The mix occurred at Vishays marking operation due to residual units left on the marking machine during February, March and April. Vishay had a procedure in place for the operator to verify the track was empty prior to the start of a new l
51、ot. The procedure was not followed.分析: Vishay确认产品是短路,最终原因被确定为被发给Heart公司额定功率低的产品混入到设备中,混入现象发生在Vishay的打标岗位,是在2月、三月份及四月份残留元件被遗留在打标岗位所致。 Vishay在操作岗位有作业程序,规定在开始打标新的批次时须检查轨道是干净的,但程序没有被执行。Process Root Cause: The actuator in the push pin mechanism used to flush residual units from the track stop working.制程根
52、本原因:推针执行器被用来剔除轨道停滞工作时的残留元件Escape Root Cause: The sample size for the post marking test is not sufficient enough to detect PPM mixture levels.流出根本原因:在打标岗位的抽样检查数对混入水平在PPM级的不良来说是不足的System Root Cause 1: The actuators are not included on a preventive maintenance schedule thus allowing actuator to degrade
53、 and become defective.系统根本原因1:执行器没有被纳入保养计划,这样允许执行器劣化及没有效力System Root Cause 2: Current training plan does not require training verification therefore it was not known that the operator was not following the operating procedure.系统根本原因1:目前的培训计划中没有要求进行培训效果验证,所以并不知道操作工没有遵守作业程序的规定5/30/2002 Rev. Orig8D Tra
54、ining8D Example 8D案例D5 Corrective Actions D5 纠正措施Process Root Cause: Replace actuators on all marking equipment to eliminate residual parts.制程根原因:在打标机上替换执行器以除去残留部件Escape Root Cause: Implement 100% quality test post marking to ensure that mixed parts will not be shipped to Heart.流出根本原因:在打标岗位实施100%检查确
55、保混入的部件不被发送Heart公司 System Root Cause 1: Incorporate a part replacement/refurbish program into the existing preventive maintenance schedule to ensure that parts are replace before they cause a problem.系统根本原因1:在现有的检修计划中增加部件置换/刷新项目,以确保部件产生问题时被置换System Root Cause 2: Modify training program to include a v
56、erification step prior to granting certification.系统根本原因2:修订培训程序,包含在批准合格前有一个检验步骤5/30/2002 Rev. Orig8D Training8D Example 8D案例D6 Implement Corrective Actions D6 实施纠正措施Process Root Cause: Completed by A. May on 5/10/02. Several lots were processed through the marking machine and the push pin properly r
57、emoved the residual parts.制程根本原因: A. May 于5/10/02完成打标机打标多个批次时,推针可正确的推离残留部件Escape Root Cause: Completed by B. Bell on 5/10/02. Several mixed devices were placed through the tester to verify that the test program would remove all defective units. All incorrect devices were removed.流出根本原因: B. Bell 于 5/10/02完成多台混料装置被安置在检查仪上以验证检查程序可以剔除不良品,所有不好的测量仪已被移走System Root Cause 1: Projected completion 6/1/02 by A. May.
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