快速反应程序：解决质量问题的反应模式(ppt-84页)课件

1、快速反应程序解决质量问题的标准化反应模式 是一个体系运用可视的方法显示重要的信息以解决重大的外部的、内部的质量失效问题。快速反应是否存在一个每天的领导层会议？ 快速反应会议可以是一个1020 分钟的站立式会议，地点可以在车间或生产会议室。 过程的责任人必须来自制造部门。 在一天的开始，质量小组应该识别前24小时所发生的重大质量问题 ，可以从一下几个方面考虑:- 客户关注的问题- 供应商所关注的问题- 造成停线的 (内部/客户)问题- 出厂审核 / 审核问题- 其他内部质量问题研讨会小组首先应该定义什么样的质量问题是重大的质量问题。当业务经理不在场时，会发生什么呢？ 在每天的制造评估会议上领导层

2、应该审核一下方面:- 和小组成员一起审核重大的质量问题- 指定相关人员负责问题的解决- 指派下次会议报告的责任人要求 (续): 责任人应该负责保证所有的问题及时被解决并且满足退出标准。 责任人的报告应包含以下几个方面的更新：- 快速反应跟踪表- 标准化操作指导书- 问题解决表 - 过程失效模式分析- 控制计划- 层级审核- 全员通告 Workforce Notification - 其他适用文件必要时在快速反应跟踪表上必要时，按照快速反应跟踪表的规定汇报给管理层 快速反应跟踪表 (Example)要评估的要点:责任人退出标准全面情况优化目视管理，将这个表格尽可能大的显示在会议室( ex.: 4

3、 x 8 dry erase board )(举例)领导层将展示一个可视的质量状况要求 (continued):不合格产品的控制遏制Establish a method to ensure that product that does not conform to specified requirements is:防止无意识使用或安装 Prevented from unintended use or installation 用统一的标签清楚识别 Clearly identified using consistent labeling 用目视管理方法建立统一的识别程序 (Example) 用

4、明亮色彩作为首选的识别方法 - 红色废品 - 黄色可疑品 - 绿色合格品不合格产品的控制标签内容IN THIS SECTION IS AT LOCAL DISCRETION标签内容IN THIS SECTION IS AT LOCAL DISCRETIONPLT001可疑品或待处理品半成品或合格品红标签表示废品。 黄色标签表示可疑产品或待处理的材料，需要返工的材料或需要进一步检查的材料绿色或其他颜色的标签表示产品是可接受的 (红色和黄色除外). .废品PLT002PLT003标签内容IN THIS SECTION IS AT LOCAL DISCRETION要求:不合格产品的控制 领导层应开发

5、，组织并维护一个统一的体系来控制不合格品. 将不合格产品隔离. 隔离区域将被标识 - 废料箱- 返工台- 返工产品标签- 溢出遏制区域 遏制工作表将被完成并用于：提供一个系统的方法遏制全部可疑品 确定不合格产品的检查范围What if potentialquantitydoes not equal total found? When do you call the customer?要求 (续): 分界点检验采用:- 对于遏制范围内的产品100检查- 在根本原因找到之前，持续时间由领导层决定 对于产品遏制问题，箱子将标识成 :- 红色不合格产品 - 黄色可疑品- 绿色分界点后的合格产品 从被认

6、可的工艺流程上拿走的产品返回时应在离开点或之前. 全部控制计划都要执行检查和测试. 注意： 如果不可能在离开点或之前返回，使用经认可的重做流程以保证一致性. 要明确脱离返工，返修和遏制区产品的程序与授权. 产品遏制问题要经领导层评估. 标准化工作(方法和顺序)“标 准 化 是 通 往 不 断 改 进 之 路.”W.E. Deming,七月 15, 1992(举例)目的: 对所有的操作实施标准化的方法和顺序。标准化工作 (方法& 顺序)范围: 装配区 制作过程 发运 / 收料 返修/返工区 所有的操作 其他支持功能 (例如：检查) 职责: 一个或两个责任人- 制造工程人员- 生产经理 精益组织.

7、 识别那些能增值的工作. 一个有效的生产顺序. 持续改进. 在过程内部减少变差. 减少浪费，解决问题和质量控制. 审核操作员与工作指导书一致 层级审核. 确保操作者统一履行相同任务和程序.标准化的工作提供了一个基础: 多功能小组应确定并列出所有要实施标准化的工序Multi-disciplinary team(s) shall identify and list all operations to implement standardized work怎样划分优先顺序的例子:- 涉及客户质量的问题 - 定义工作顺序和方法的必要性- 离线返工Off-line Rework- 高的RPN- 员工流动

8、Employee Flow-through多功能小组定出标准化工作的指导书并张贴到每一工位.新员工要被培训使用标准化工作（标准操作员培训）要求:标准化操作Standardized Operations客户周期时间工作顺序在制品的标准化标准化操作步棸TAKT TIME 生产出一个单位的时间Time in which a singleunit is to be produced操作工的移动OperatorMovements相同顺序相同动作每一循环工作需要的最小库存Minimum stock necessaryto do work in the samesequence with the same

9、movements, every cycle列出客户周期时间的理由: 使领导层确信业务如批准的那样在运转Assures leadership that operation is running as approved 可减少生产过剩 Overproduction can be reduced 改进生产调度 Improves production scheduling 操作员可介入到决策过程Operator involved in decision making process 设备显示出磨损迹象时操作员能知道Operator knows if equipment is showing sign

10、s of wear. 安排维护与修理时间 Maintenance and repair time allocated 清扫成为生产流程的一部分Clean-up becomes part of the production process 质量检查变成日常事务Quality checks built into the daily routine 为实施分层审核而安排时间Time allocated for conducting Layered Audits 目视管理元素 显示工作顺序的理由: 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 减少组分被遗漏的风险Reduces the risk of components being left out 没有操作被遗漏或忽略No operations are skipped or omitted 提醒进行质量检查及频率Quality checks and frequency are called out 很容易确定方法改进Process improvements are easily identified 新手培训更一致Training new operators is more consistent显示标准工作程序的原因: 操作员控制再填充箱柜的频

12、率Operator controls frequency of refilling bins 警告材料管理员短缺或过量库存Alert material handler of shortages or excess inventory 减小由于原料储运损耗而造成的设备停工期Reduces equipment downtime due to stock outages 工作区域减少混乱 减少在制品 允许材料管理员处理他们的时间Allows material handler to manage their time Standardized Operations Worksheet And Layo

13、ut标准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)标准化的操作工作表和计划应包括Standardized Operation

14、s Worksheets And Layout shall include:- 工作原理Work Elements- 操作员动作Operator Movement- 操作周期时间Operation Cycle Time(Example)(Example)要求（续）: 标准化的工作说明书应通过分层审核检验任何操作在持续12个月里由于缺乏坚持标准化的工作说明出现的不一致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. 多功能小组应根据正在进行的质量成绩对标准化的工作说明书做持续的改进Multi-disciplinary team(s) shall continuously develop/improve standardized work instructions based on ongoing quality performance.操作员培训的标准化操作员的培训是否经过验证并记录在案？ 操作员标准化培训要求Stand

16、ardized Operator TrainingRequirements多功能小组决定每一道工序至少的培训内容A cross functional team shall define the minimum training content for each operation.此组织决定谁来实施培训The organization shall identify who will conduct training.培训员监督新操作员的行动，必要时重新培训以确保标准工作指导被遵循Trainers shall monitor new operators activities and retrai

17、n if necessary to assure Standard Work Instructions are being followed.培训员通知下道工序潜在的缺陷The trainer shall notify downstream operations of potential defects.此组织应建立必要的文件及跟踪方法The organization shall establish required documentation and tracking methods.培训者应指导操作员使用标准操作员培训表Trainers shall instruct operators u

18、sing the standard operator training sheet. (Example)标准化操作培训记录(Example)Application: 运用：任何新操作员都应完成下表The following shall be completed with any new operator (for any given operation).审核Review 完成Complete标准化的工作指导Standardized work / job instructions要填充的质量记录Quality records to be filled out (eg. Check sheets

19、)示范操作和问题回答Demonstrate the operation and answer questions示范测量和回答问题Demonstrate gaging and answer questions新员工是否进行操作并回答问题Have new employee run operation and answer questions讲授过去的问题Teach past problems (eg. FMEA, Top Problems List)检验首次生产，培训作为必须Verify first units produced, coach as needed换班时报告，重新检验标准化的工作与

20、产品质量Return within the shift, verify std work & product quality again大约1天报告，重新检验标准化的工作与产品质量Return in approx. 1 day, verify std work & product quality again向下游业务通报潜在缺陷Notify downstream operations of potential defects雇员签名Employee Signature _ 培训员签名Trainer Signature _Operation Name and # _零件（产品）功能Part (p

21、roduct) function安全/设备操作 Safety/ Equipment Operation(Example)标准化的操作培训记录 标准化操作员培训要求操作员跟踪表应张贴在每一操作位置通过分层审核检验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.追加的雇员如果在最近三个月内没有

22、经过培训不能执行工作Supplemental employees shall not perform the job unless they have been trained within the last three months.培训者应定期检验质量以确保达到所有的标准。最起码培训者应在一个换班与一天内报告。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.操作员培训应记录在“操作员培训跟踪表”里Operator training shall be tracked on “Trained Operator Tracking Sheets”. (Example)已培训操作员跟踪(Example)Operation Name / # _DEPT. ASSIGNED EMPLOYEESUPPLEMENTAL EMPLOYEELATEST TRAINING DATE AND TRAINER INITIALSLatest Job Instructio

24、n Rev. Date标准化的培训小结组织应该建立必要的文件和跟踪方法确定操作员培训负责人。保证操作员培训通过“操作员培训跟踪表”跟踪 ensure operator training is being tracked on “Trained Operator Tracking Sheets”. 在每一操作位张贴操作员跟踪表，通过分级审核检验 post operator Tracking Sheets at each operation, and verify through Layered Audits.schedule refresher training for assigned ope

25、rators at local site discretion.降低风险的程序积极主动RPN 降低程序:降低潜在质量失效被动对已发生的质量失效建立防错装置定义PFMEA结构化程序适合于与失效模式有关的识别和排除方法A structured procedure for identifying and eliminating process related failure modes.识别每一个过程步骤的分析技术 An analytical technique that identifies for each process step程序可能不能达到要求的情形 Ways that a proces

26、s may fail to meet requirements内在/外部消费者的严重度Consequences to the internal / external customer (严重度)失效可能发生的频率Frequency that the failure will/could happen (发生频率)当前控制的效果Effectiveness of current controls (预防核可探测度)原因和结果的排队Ranking of causes and effects (风险顺序数)会出现什么问题What can go wrong?它是怎样影响客户的How does it af

27、fect customer?多久发生一次How often does this cause happen?如果问题发生，有多大可能我们会注意道它How likely are we to notice if this happens?风险程度有多高How high is the risk?PFMEA: 过程失效模式及影响Process Failure Mode & Effects (example)(AIAG PFMEA Third Edition)严重度分级Severity Rankings(AIAG PFMEA Third Edition)发生频率分级Occurrence Ranking(A

28、IAG PFMEA Third Edition)可探测性分级Detection Rankings(AIAG PFMEA Third Edition) 风险顺序数是严重度，发生频率与可探测性结合在一起的结果Risk Priority Number (RPN) is the result of Severity, Occurrence and Detection rankings.(Example)严重度Severity x 发生频率Occurrence x 觉察可能Detection = RPN风险顺序数Risk Priority Number (RPN)所有的质量管理体系要求的制造步骤与支持功

29、能如接受检查、材料处理、分类与发运等都要完成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 必须: 与AIAG的原则和客户的要求相一致 定期更新（动态文件） 所有的生产线/产品号都有相应的PFMEA 包含所有过程和工序 应用于持续改

30、进 准确定义严重度/频率/可探测度的等级主动降低风险的要求Site Leadership 领导层最起码每年一次评估PFMEA培训需要Leadership should review the need for PFMEA training at least once per year. 领导层应支持RPN减少活动并提供必需的资源Leadership shall support RPN reduction activities and provide necessary resources. 领导层应评估RPN减少跟踪表RPN reduction tracking charts shall be

31、reviewed by leadership. 领导层应确保PFMEA的准备与评估利用了正规的多功能小组Leadership shall ensure that formal multi-disciplinary teams are utilized in the preparation and ongoing review of PFMEAs.主动降低风险的要求主动降低风险的要求 根据过程的稳定性，顾客的反馈等，供应商领导层决定PFMEA评估的频率（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应经历完整的评估包括以下内容：PFMEAs shall undergo a complete review including the following: 确认所有的操作/步骤都被包括进去而且准确Verification that all operations/processes are included and accurate. 所有操作控制都被包括进去而且准确All process controls are included

33、and accurate.通过数据分析了可能性排队Occurrence ratings are analyzed using data (SPC, FTQ, Quality Gate, C.A.R.E, Scrap, and Layered Audit results) 用内部和外部顾客的反馈分析了可检测性排列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) 评估完成后，根据新的数据列出最高的5个风险减小机会Upon completion of the review, the Top 5 (RPN) Risk Reduction Opportunities are revised based on the new data. 对最高的5个机会考虑评估所有的RPN失效模式与检测方法The Top 5 list shall consider review all RPN failure modes for common causes and Detection methods. PFMEA评估选择标准Select

35、ion criteria for PFMEA review:获得的产品或者来源于从前供应商的业务Product from an acquisition or business from a previous supplier未经足够部门间参与得到的PFMEA。 PFMEA developed without adequate cross-functional involvement 对那些有PR/R历史的零件，顾客抱怨，担保或FTQ问题的PFMEA PFMEA for part(s) with history of PR/R, Customer complaints, Warranty or

36、FTQ issues 可能性排队发生显著变化的Occurrence rating (FTQ, scrap, etc) have changed significantly 有最老修改日期的PFMEAPFMEA with oldest revision dates主动降低风险的要求前5位高RPN值跟踪表(Proactive)(Example)Example: GM form1927-21(This is for reference only; check for latest revision) 被动降低风险的要求 应利用多部门小组来解决问题Multi-disciplinary team(s)

37、shall be utilized for Problem Solving 小组确定每一RPN 的PFMEA严重性，可能性与可检测性Team(s) identify true PFMEA Severity, Occurrence and DetectionRating for each RPN. 小组定出行动计划来防范5个最多的故障 Team(s) shall develop an action plan to Error Proof top 5 failures. 推荐的行动是减少或防止失效模式的进步Recommended Actions are improvements that will

38、 reduce or prevent the Failure Mode. 指定一名小组成员来负责确保推荐的行动被执行A team member shall be assigned to be responsible for ensuring that the recommended action is implemented. 确立合理的目标完成日期Reasonable target completion dates shall be established.被动降低风险的要求 当防止错误不可行时，应建立改进检测的计划Where Error Proofing is not feasible,

39、a plan to improve detection shall be established.错误防止应通过“防止错误确认程序”来检验Error proofing shall be verified per the Error Proofing Verification Process.当制定了纠正行动后，小组应验证新的可能性与可检测性排序以及结果RPN When corrective actions have been established, teams shall validate the new Occurrence and Detection rankings and resul

40、tant RPN.制造场所领导层应确定定期进步评估Manufacturing site leadership shall schedule regular progress reviews.风险减小总结主动地Proactive积极减小潜在质量失效地风险Actively reduce the risk of potential quality failures .领导层应评估并支持风险减小行动Site leadership shall review and support the risk reduction activities.PFMEA 应遵照AIAG标准并相应更新PFMEAs shall

41、 conform to AIAG standards and be updated accordingly.PFMEA最少应每季度评估一次A minimum of one PFMEA shall be reviewed per quarter.被动Reactive多部门小组应确定最高5个问题Multi-disciplinary teams shall identify the top 5 issues and problem solve the issues.小组应在采取纠正措施后更新PFMEA Teams shall update PFMEAs with all corrective act

42、ion measures.防错装置确认防错装置被验证过吗？把事情第一次做对99.9把事情第一次做对99.9意味着 每月一小时不安全的饮用水 每天有两次不安全的着陆在OHare 机场。 每小时16,000 件邮件丢失。 每年有20,000 药方有错 美星期500 外科手术出错 每天50 新出生婴儿被医生丢掉。 每小时22,000 支票从错误地帐号扣除 每人每年错过了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防错装置失效：带有防错装置功能：放错装置确认的目的： 确保用于生产和装配的放错装置的功能运行正常To ensure error proofing devices used in the manufacture and assembly of product are functioning properly.放错装置的确认注意: 这不是一个主要的量具。（例如：量具设定为零）This is not mastering a gage, (e.g. Setting gage to zero) 它是通过已知的好的/坏的零件来检查的 It

45、 is sending a known good/bad part through. 装配区域Assembly Area 制造工序Manufacturing Operations 发运/接收Shipping / Receiving 所有的工序All Operations 其他支持功能Other support functions范围： 责任: 专人负责（一个责任人） 定义: 防错装置（不可制造）防止制造者或装配不合格产品的设备Error Proofing Device (CAN NOT MAKE) - Devices which prevent the manufacture or assem

46、bly of non-conforming product. 错误检测设备（不能通过或不能接受）防止传递不合格产品的设备（如100在线检测设备）Devices which prevent the transfer of non-conforming product 所有可能失效，磨损，未对准或没有校正的防止错误/检测设备最起码每天要检验一次。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: 防错装置确认ERROR PROOFING VERIFICATION 放错装置的主控文件应有识别号和位置Master Document of Error Proofing devices, with identification number and location 确认频率Verification frequency 确定标准样件（好的/坏的）已保证不合格品被检测出来Identify masters (Good/Bad) and defect being checked 明确定义反应计划如果防错装置失效Cle

48、arly defined reaction plan if device fails to detect当防错装置不能检测出残次，什么时候停机？品When/if shut down when device fails to detect bad part? 遏制计划？Containment plan? (100% 检验Inspection, etc.) 通过防错装置的可疑品是否被返回？Are suspect parts rerun thru Error Proofing device? 怎样/什么时候防错装置被维修？“ How/when is Error Proofing device rep

49、aired? 在防错装置确认之间要生产的产品的批量大小 Lot size of parts run between Error Proofing verification 用程序的历史记录决定验证的频率 History of process to determine verification frequency 程序是否稳定 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) 分层审核 领导层执行了分层审核了吗分层审核提供了一套系统来：Layered Audits provide a system to: - 检验与备有证明文件的操作一致 - 灌输纪律instill discipline - 促进沟通improve communication - 改

51、善总体质量improve overall quality分层审核由制造者领导层掌握.质量和其他职能部门参与并支持分层审核系统Layered Audits must be owned by manufacturing leadership. Quality and other functions will participate and support the Layered Audit system.制造和装配高风险的项目应该每班最少一次分层审核Layered Audits shall be conducted for manufacturing and assembly of high ri

52、sk items at a minimum of once per shift. 分层审核的频率由生产量或者操作相关的风险水平决定Frequency of Layered Audits is based on production volume or level of risk associated with process. 分层审核补充了现行的控制计划和工作指导检查 分层审核 应建立分层审核时要检验的高风险项目核对表A check list of high risk items to be verified during Layered Audits shall be establishe

53、d. 在建立核对表时要考虑的因素Elements should be considered in developing the check list. 评论由内部审核产生（加工，安全，总务，常规管理等），包括在分层清单上可重复的不一致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. 分层审核应核实适当的质量文件Layered Audits sh

56、all verify appropriate quality documentation 分层审核的结果要记录Layered Audits results shall be recorded. 出现问题应马上解决Non-conformities shall be addressed immediately 分层审核检测出问题的行动计划应记录并随时备用Reaction plan(s) for non-conformities detected during Layered Audits shall be documented and available for use. 纠正行动也要文件化Cor

57、rective actions shall be documented. 审核结果应总结并交生产地领导层审阅Audit results shall be summarized and reviewed by the manufacturing site leadership. 分层审核结果合适时应增加到“经验教训”数据库中Layered Audit results shall be added to the Lessons Learned database when appropriate. 要求 : 分层时间频率Layered Audit frequency:- 高风险项目每班最少一次Hig

58、h risk items shall be verified a minimum of once per shift.- 生产检查员应(每天)确认操作员完成了质量文件The manufacturing supervisor shall verify (daily) all quality documentation is completed by the operators. - 生产区经理应（每周）确认检查员检验完成The manufacturing area manager shall verify (weekly) that supervisor verification is bein

59、g completed. - 生产领导层应（每月或季度）定期组织加工检查评估Site leadership shall conduct periodic process verification assessments (monthly/quarterly). Operator SupervisorMTWTFMTWTFMTWTFManagerSite LeaderLAYERED AUDIT MATRIX (Example)(Example)(Example)C.A.R.E.质量确认顾客满意度总结与评估“保护顾客”C.A.R.E.CUSTOMER ACCEPTANCE REVIEW & EVAL

60、UATION顾客满意度总结与评估 保证你的顾客无不合格和不符合产品Protects your customer from nonconforming product & discrepancies. 提供快速纠正行动的信息Provides information for rapid corrective action. 补充控制计划Supplements the control plan. 应用于与零件相关的顾客满意项目Applies to customer satisfaction items that are part related. 工厂经理和质量经理应推动行动The Plant Ma