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1、Document No: 11QR- 002 Date of Occurrence: 01/21/2011 Date Initiated: 01/21/2011 Date Closed: Vehicle Family Affected: 1500825-0005-01 Source of Complaint: HNS Other Reference Number (specify): 1500825-0005-01 Discipline12345678Issue Identification & AssessmentContainment & Interim ActionRoot Cause
2、AnalysisImplement Permanent Corrective ActionVerify Corrective Action PlanControls & PreventionsVerify Corrective Action Resolves IssueLessons Learned1:Issue Identification and Assessment (Must be completed within 24 hours)1.1:Problem Description Describe the problem with a well-thought-out Problem
3、Statement. The Problem Statement communicates the scope of the problem that the team is working on and gets the team focused. Provide information relevant to the problem to help the team get started and clarify what is expected from the team. Consider the following, as applicable, in developing the
4、problem statement: What is the problem or actual condition? - state in terms of object and defect Where was the problem found first? How was the problem detected? How is the issue measured? Current status how many vehicles or parts are affected? VIN number, etc.;Questions & Considerations: Responses
5、: Identify the problem? 1/21 HNS found one LNB（SN：K10S0066050L）with a loose internal screw. It rattled noticeably. Show a picture(s) of the issue as applicable (i.e. a s/w issue would not require a picture) What data is available to confirm and diagnose the problem? 利用MES 查找厂内测试记录。SN：K10S0066050L 厂内
6、生产记录Pass，组装投料时间9/29，测试完成时间9/30，出货时间10/13。 What is the level of urgency and impact of the problem? Use 5 whys to assist in developing the problem statement.为什么 MTIW 厂内IPQC未检查到螺丝脱落？为什么螺丝脱落会流到厂外？为什么 QC 未检到螺丝脱落？为什么MTI未检查到螺丝脱落？ Develop a Problem Statement? Note: The Problem Statement communicates the nat
7、ure of the problem to the team, focuses the team on the scope of the problem, provides data and information on what the problem is AND what it isnt and lets the team know what they are expected to do.) 1 HNS 1/21 反映KA 1ea产品（SN K10S0066050L）有异响，查厂内生产记录，为各站PASS。2 2/17 产品寄到 MTI 后，MTI 进行 X-ray照射，发现有一颗螺丝
8、脱落。3 2/17 拆开产品后发现产品漏点螺丝胶。3 FRB Review 生产流程，涉及到锁Spacer螺丝的制程有2处（组装线锁螺丝/回常温后加锁螺丝），可卡住的制程有3处（组装线IPQC/点螺丝胶后IPQC/包装线IPQC）1.2:Team FormationWhen setting up a problem-solving team, consider team membership, roles of the members, boundaries of freedom for the team and the team start-up process. Questions & C
9、onsiderations: Responses: Who are the project team members? Listed in the table as below What is the role of each team member? Production Engr. Find out the root cause Production & Production Engr. - Support root cause analysis and implement modificationQA - Verify modification effectiveness, reassu
10、re the quality remain meet all the requirements and control all document changesLeader Control overall schedule and integrate all functions to reach the fastest and best solutionTeam MembersNameEmailFunctionPhone NumberLeaderBrand xiexie_brandProduction86-510-85228800 #4513ScribeLei LiuLiu leiQA86-5
11、10-85228800 #4068MembersJing YangYang_Jing QA86-510-85228800 #3163Haiyan wangwang_haiyanProduction86-510-85228800 #4509Bangkai laoBangkai_lao Production86-510-85228800 #4509Liu weiweiLiu weiwei Production Eng86-510-85228800 #5033 What are the boundaries of freedom for the team? (Lets the team know w
12、hat they can do and what they cannot do)All changes must meet HNS specifications。 What are the team ground rules?Find Root cause and Corrective action。 Do the expectations clarify the role the team should play (determine root causes and implement or recommend a solution), specify the deadline and in
13、clude monetary limits for the team? The problem-solving team is expected to:1. Find out the root cause of the problem 2. Provide effective correction and come out preventive actions2:Containment and Interim Action (Must be completed within 24 hours)Interim containment means that a “band-aid” is put
14、in place to prevent the effect of the problem or to prevent the full effect from impacting customers and/or employees while a permanent solution is being developed and implemented. Interim containment may include: sorting bad parts from good ones, adding operations, using additional labor on the pro
15、cess and additional inspection. Interim Containment tools:1. Brainstorming: come up with short-term containment ideas.2. Mistake-proofing: ensure problem does not get to the customer. Some short-term Band-aid ideas: Sorting bad parts from good parts Added operation Using addition labor on the proces
16、s Additional inspectionQuestions & Considerations: Responses: Have the interim containment measures been verified to work? What is the quantity of good parts the plant needs to keep running? (today, tomorrow, next day and so on)1.产线针对厂内所有WIP 1824 ea进行全检螺丝是否松动，结果未发现不良-1/21 done2.产线对所有成品 560 ea进行3个轴向的
17、晃动，未发现不良 -1/21 done2.IPQC检查螺丝的后站“锁cover”人员追加工作内容：检查螺丝是否松动-1/21 done Has the impact of the interim containment measures been tested to ensure that additional problems are not created? 已驗證，没有再发现类似的问题。 Are the actual additional costs of the containment measures known and been verified that they are “wo
18、rth” it? 产生额外的检查费是值得的。3:Root Cause Analysis Defining the root causes is the core of the 8-Step problem-solving process. This is normally the toughest aspect of the problem-solving process; if the root causes of the problem were obvious, then the problem would have been solved already. There are usua
19、lly two families of causes at work when we know there is a problem. The first, the causes that appears to be the problem, are frequently symptoms, not root causes. The specific cause or causes that allowed the apparent causes or symptoms to occur are the root causes, often buried deep in the process
20、. See “The Memory Jogger Library for assistance with implementing specific quality tools. Location of memory jogger is: mfg on EMC-SNAS (Styx)O:ISO_INFOMemory JoggersThe memory jogger library.pdf.Partial list of tools & techniques to use: Cause and Effects Diagram Run Chart Flowchart Scatter Diagram
21、 Process Capability Measures Charts & Graphs Histogram Pie Charts Checklists Pareto Analysis Surveys Data Collection Forms Force Field AnalysisQuestions & Considerations: Responses: What techniques have been used to discover the root causes? (e.g.: The 5-Whys, What isWhat isnt Analysis, Timeline Ana
22、lysis, Failure Analysis, Simulations, Statistical Analysis) (see guidelines for more information)1 有实物作为分析依据。2 Flowchart Have you asked the Root Cause Question: “Do these causes explain all that is known about what the problem is, as well as all that is known about what the problem isnt?” This is re
23、ally a two-part question: make sure the root causes found fits both the “is” and the “isnt” sections of the question. If the causes being tested dont fit both, then they are probably not the root causes. Ka LNB production assembler not re-tighten screw well after temperature test working area among
24、glue-applying, IPQC and cover assembly not clearly separated,It made the concern LNB has chance escaping both glue-applying and IPQC processes before cover installed and caused the problem as reported. Have the root causes identified been verified? Verification may require a series of confirmation r
25、uns. NA4:Permanent Corrective Action Plan Often the solution or solutions become obvious once the root causes are known. However, sometimes, a systematic approach is needed to use the root cause analysis to develop a solution. If the solution is obvious, select the best solution or mix of solutions
26、that will lead to a robust, yet cost-effective, resolution. If solutions are not yet evident, follow the data trail. When solutions are not obvious, often the root cause has not been found/Partial list of tools & techniques to use: Brainstorming Run Chart Voting & Ranking Problem Statement ROI Calcu
27、lations Histogram Histograms Workflow Diagrams Affinity GroupingQuestions & Considerations: Responses: What is the permanent corrective action? Has the solution passed the tests of practicality, feasibility and cost-effectiveness? When will it start? When will parts resulting from the permanent corr
28、ective action arrive at the plant?Method Applying a mask marking screw in sequence, to remind assembly technician to strictly follow procedure requirements to tighten the screw.) - Wuxi Engineering by 1/17 To clearly separate working area among glue-applying, IPQC and cover assembly.Wuxi production
29、by 2/24 To modify MES routing for IPQC process added to prevent any unit escape the IPQC test before shipment .Wuxi production by 3/15 Sampling check, 7ea per hour, screw torque and glue-applying during in process audit.- Wuxi QA by 2/28Man Re-training and re-qualify the technicians - Wuxi Productio
30、n by 1/17 Assign a dedicated IPQC stamp for all IPQCs - Wuxi Production by 2/25 How has the permanent corrective action been Error or mistake proofed? Have you designed it out?FRB相关成员集体讨论并达成一致意见。 What is the first plant sequence number to receive parts resulting from permanent corrective action?MTIW
31、 KA BAND 组装线。 Will any parts produced prior to the permanent corrective action be sorted, reworked, or scrapped? 厂内所有半成品与成品做返工筛选，未发现不良品。 Has a process change request been issued and approved indicating the change or changes being made?是5:Corrective Action Plan Verified Once the solution and its impl
32、ementation are approved, the next step is to create an Action Plan. The Action Plan outlines what steps are needed to implement the solution, who will do them, and when they will be completed. An Action Plan documents what needs to be done, who will do it, and when will it be done by. Partial list o
33、f tools & techniques to use: Problem Statement To review the solutions against the objectives Activity Plan Used to generate a full listing of the task. Microsoft Project chart Used to manage project resources and schedules.Questions & Considerations: Responses: Attach Action Plan (who will do what
34、by when), include criteria, choose the indicators and record baseline data. Apply tests and appropriate statistical data to assess the corrective actions. Determine if the corrective action solved the problem and avoided new problems. Applying a mask marking screw in sequence, to remind assembly tec
35、hnician to strictly follow procedure requirements to tighten the screw.) - Wuxi Engineering by 1/17 To clearly separate working area among glue-applying, IPQC and cover assembly.Wuxi production by 2/24 To modify MES routing for IPQC process added to prevent any unit escape the IPQC test before shipm
36、ent .Wuxi production by 3/15 Sampling check, 7ea per hour, screw torque and glue-applying during in process audit.- Wuxi QA by 2/28 Re-training and re-qualify the technicians - Wuxi Production by 1/17 Assign a dedicated IPQC stamp for all IPQCs - Wuxi Production by 2/25 Part of implementing a soluti
37、on is to document new procedures or changes to procedures as well as any changes that relate to the organizations quality system; has this been done? List any new or revised procedures that were implemented.NA Has training to support the new system(s) been developed and provided? 改善注意事项均已向相关岗位人员宣导 。
38、 After people use the new or revised process a few times, they most likely will have some improvement ideas. Have the suggestions been assessed, and have corresponding adjustments been made to the process, has the documentation been updated, and has retraining been provided? N/A6:Controls and Preven
39、tion The job of a problem-solving team is not complete once the solution is implemented. Preventing recurrence is an important part of a problems solution. To prevent recurrence of the problem, the team must verify that the outcome of their Action Plan works and they must validate that the outcome i
40、s on-target. Controls refers to processes used to ensure that the corrective actions solutions are working the way they were expected to work and that the solutions continue working even after it has been verified. Prevention involves modifying management systems, operating systems, practices, proce
41、dures to prevent problem from re-occurring. What systems are depending on this information?Partial list of tools & techniques to use: Testing for robust solution Ensures mistake-proofing has been used to prevent recurrence, Process Capability Measures Did we improve our ability to meet customer? SPC
42、, audits, etc., PFMEA / DFMEA Have we reduced our relative risks?Questions & Considerations: Responses: Has the outcome of the Action Plan been verified to work 以上改善计划将在整个生产过程中持续跟踪。 Has the outcome been validated to be on-target?Yes Have Action Plan results been documented, related procedures update
43、d, and corresponding changes to any affected quality system elements made?All related documents will be updated before 2/25/2011 Have audits been established to assess the use and effectiveness of the solution to ensure that the gains are held?Regular internal audit will be established to check the
44、implementation and effectiveness of the solutions. Have the results been leveraged to prevent occurrences of like problems in all similar operations? FRB全面review组装和测试线的作业流程，避免类似由于人员疏忽导致失效的问题再次发生。 What follow up activity will be conducted to confirm the effectiveness of all countermeasures?1 线长每日巡线查看
45、电动扭力起子使用是否符合要求，工位区分是否清晰。2 QC巡线每日稽核电动扭力起子使用是否符合要求，工位区分是否清晰。 Has the Control Plan, PFMEA, and DFMEA been updated to reflect this issue?NA7:Verify Corrective Action Resolves Issue Confirm that the selected corrective actions will resolve the problem and will not cause undesirable side effects. Cover co
46、ntingency actions, if necessary, based on the potential severity of the side effects. Verification involves conducting experiments, tests, etc., to ensure that the corrective actions already in place are solving the problem at the plant.Partial list of tools & techniques to use: Process Changes Ensure process changes have been implemented to prevent recurrence Design Changes ECNs have been implemented Questions & Considerations: Responses: Has the changes to the appropri
