BIQS审核检查表中英文

#DIV/0!0 0 0 0PROBLEM SOLVING CLOSURE EFFECTIVENESS:QUALITY ISSUE # FAST RESPONSE PROCESS USED PROBLEM SOLVING FORM COMPLETE QUALITY ALERT POSTED DEPT CONTAINMENT WORKSHEET USED FMEA UPDATED (NEW RPN) CONTROL PLAN UPDATED STANDARDIZED WORK UPDATED TRAINING COMPLETED ERROR PROOFED ERROR PROOFING VERIFICATION COMPLETE ADDED TO CARE / GP12 ADDED TO LAYERED AUDIT GENERAL AREA TAGGING / NC MATL SEGREGATION CORRECTIVE ACTION EFFECTIVENESS MONITORED ENGINEERING CHANGE REQUEST / PROCESS CHANGE REQUEST PTR CONDUCTED READ ACROSS TO SIMILAR LINES / PROCESSES CHANCES OF RECURRENCE ISSUE DESCRIPTION* Instructions - Get 3 Closed Problem Solving Issues from the Supplier (different plant/product) and review each with the above check list to measure the effectiveness of the problem solving.* Supplier: Be prepared to show documentation/evidence that supports completion of the key components of effective problem solving identified in the chart above.X= NoncompliantO= CompliantLocation: BIQS Score:DUNS:Supplier: Audit Date:Auditor Name:Total Elements: Number of Green: Number of Yellow: Number of Red:GM CONFIDENTIAL Revision: 03/10/15BIQSItem # BIQS Requirement BIQS要求 BIQS Calibrator Guidelines (Look For) 审核指引 Score Comments 评价BIQS -1Nonconforming Material / Material IdentificationTeam members have standardized work and understand what todo with non conforming / suspect material.Conforming material is handled, stored and identifiedappropriately.Non conforming / suspect material is clearly identified and/orsegregated for review/disposition (i.e. appropriate color coding forfoot printing red, yellow, green).A containment method is in place to ensure that an effectivebreakpoint has been established. Containment activities andresults are documented.Traceability is applied according to the traceability methods of thefinished product.1.有不合格零件的处理流程，员工理解如何处理不合格 /可疑零件。2.合格物料得到正确的处理，存储和识别。3.对不合格 /可疑品进行清晰的标识 /隔离，以进行评价和处理。（例如 红 /黄 /绿颜色）4.有相应的遏制方法来确认有效的断点已经被建立，遏制行动和结果要保留记录。5.零部件的追溯要求Sample audit to verify that team members understand what to do withnonconforming / suspect material.Confirm that conforming material is handled, stored and identified appropriately.Confirm that nonconforming / suspect material is clearly identified and/orsegregated. Red, Yellow, Green stoplight approach is adhered to for footprinting, containerization, table marking and tagging.Audit that all parts removed from the process are identified, accounted for(FTQ), and reconciled to eliminate mishandling of material.Verify use of Department Containment Worksheets, with potential partslocations by operation identified to ensure no parts are missed during acontainment and all parts are reconciled. The containment worksheets mustcover from the incoming material, process and shipment.Scrap or Suspect parts/containers clearly segregated from other parts.Auto Reject stations with Locked reject bins, with controls on how bins areemptied to ensure all parts are reconciled.Parts should be physically tagged or painted for identification purposes and todrive a physical act during handling, which will reduce the chances ofmishandling parts.Overall WPO use 5S* How to Score -Green: A mature, well-defined, quality system or process is in place, being followed/utilized as directed, and the system or process does not placeGM at unnecessary risk.Yellow: Quality system or process is in place, but is not followed/utilized as intended.Red: Quality system or process is not evident, or the current system or process in place puts GM at significant risk.Nonconforming Material / Material Identification 不合格物料 /物料标识管理Layered AuditGM CONFIDENTIAL 3/10/15BIQS -2Layered AuditLayered audits are in place to assess compliance to standardizedprocesses, identify opportunities for continuous improvement , andprovides coaching opportunities.Layered audit process is owned by Management. Audit plan shallinclude multiple levels of Management.Audits are tracked and their results recorded.Follow up to address non compliance is in place.1.有分层审核流程以确认标准化作业的实施，识别持续改善机会，并对员工提供现场指导2.领导层负责分层审核的实施，分层审核计划应该包含每一级管理层。3.跟踪分层审核的实施并记录审核结果。4.对审核发现的不符合项需要改进对策。Layered Audit is an effective tool to confirm the processes are operating atstandard, and enhance continuous improvement.Leadership utilizes an audit process by going and seeing on the shop floor tocheck process compliance, employee behavior and knowledge. Leadershipuses Layered Audit as an opportunity for coaching. Recognition is used toreinforce the right behaviors.Ask Leadership how Layered Audit works in the organization, who is involvedin the layered audit process, what is the frequency of layered audits.Is the layered audit sheet content relevant for the user (have each principlecalibrator review respective part of the audit sheet)? Layered audit questionsare reviewed from time to time to focus on the plant weaknesses.Check that all findings are recorded on the audit sheet and those not solvedwithin the shift are transferred to countermeasure sheets.0GM CONFIDENTIAL 3/10/15BIQS -3PFMEAsAll operations have been analyzed for risk using a PFMEA.PFMEA workshops must be done by cross functional teams,including manufacturing team member input. Risk Priority Number(RPN) values must be consistently applied using Severity,Occurrence and Detection ranking tables.Failure modes are comprehended in the PFMEA (i.e. wrong parts,mixed parts, containment control, etc.).1.运用 PFMEA来辨识所有操作存在的风险。 PFMEA workshop 应由跨功能小组完成，包括制造团队的输入，严重度，频度和探测度打分严格遵循 SOD表要求。2.FMEA中的失效模式要完整（比如装错件，混料等）Look for PFMEAs to be available for all operations within the plant. ConfirmPFMEA workshops are done by cross functional teams, including mfg. teammember input. Confirm RPN values are consistently applied using Severity,Occurrence and Detection ranking tables.Confirm material handling failure modes are comprehended in the PFMEA (i.e.wrong parts, mixed parts, containment control, etc.)0BIQS -4PFMEAs - Risk Reduction & Annual ReviewMonthly RPN risk reduction reviews by product focused onpreventing defects from leaving the work station are held to drivecontinuous improvement. Action plans for top issues mustinclude: 1. Recommended actions, 2. Responsibility, 3. Timing.Reverse PFMEA process is in place to identify new potentialfailure mode in the shop floor1.按照产品类别定期开展 PFMEA风险降低评审，预防缺陷离开加工工位，进行持续改善。对高风险项要有风险降低对策，对策包含建议措施，责任人，完成时间。2.实施主动风险降低活动（反向 PFMEA）以识别新的过程失效模式。Look for evidence of monthly cross functional risk reduction reviews focused onpreventing defects from leaving the work station. Confirm action plans for topissues include: 1. Recommended actions, 2. Responsibility, 3. Timing.Plant Management shall be included in top risk reporting and approval ofcountermeasures.Verify if Reverse PFMEA (On-station reviews) findings are driven back into theProcess Flow, PFMEA, Control Plan, and Work Instructions as applicableBest practice cross functional line site review for RPN reductions0Managing RiskGM CONFIDENTIAL 3/10/15BIQS -5Bypass / Deviation ManagementThe plant shall identify manufacturing processes and errorproofing devices which can be bypassed or placed in deviation.Risk Priority Number (RPN) for all approved Bypass / deviationprocesses are evaluated and risks are reviewed. Standard workinstructions are available for each Bypass / deviation process.Implemented bypasses/deviations are reviewed in dailyLeadership Meeting with the goal to reduce or eliminatebypassed/deviated operations. Processes/devices in bypass /deviation must have a quality focused audits performed. Supplierlocations that have a process in bypass/deviation shall have thebypass/deviation process checked on the daily LPA. Restartverification is documented for defined period. It should be 100%checked for all features1.工厂应识别可屏蔽的制造过程和防错装置 .对所有批准的屏蔽过程，要评估替代方案的 RPN值和风险 .每一个屏蔽过程的替代方案都应有相应的标准化作业指导书 (JES/TIS)。2.对正在实施的屏蔽应在每日分层审核中进行质量关注评审，并在管理层会议上进行回顾以减少或者消除屏蔽。屏蔽解除或正常工序重启时，要按照规定频次对重启工序进行验证 .(例如：对于连续缺陷重启时要连续确认 5件 /对间歇性缺陷在一定时间内进行 100%检查）Look for the plant list of manufacturing processes and error proofing deviceswhich can be bypassed or placed in deviation. Confirm that Risk PriorityNumber (RPN) for all approved bypass / deviation processes are evaluated andthat Standardized Work is available for each bypass/deviation process. Supplierlocations shall have a written and approved bypass/deviation procedure thatincludes customer notification.Ensure implemented bypasses/deviations are reviewed in Fast Response withthe goal to reduce or eliminate bypassed/deviated operations. Look forevidence of the bypass / deviation checklist being used for processes/devices inbypass.0GM CONFIDENTIAL 3/10/15BIQS -6Error proofing VerificationAll Error Proofing Devices are checked for function (failure orsimulated failure) at the beginning of the shift. Otherwise accordingto the process control plan. Error Proofing Masters/Challengeparts (when used) are clearly identified. Records of verification areavailable.When applicable the rabbits part are calibrated.所有防错设备在开班前 (或者按控制计划规定的频次）要进行功能确认（失效或者模拟失效），以确认防错有效。防错验证用样件要有清晰标识。要保留防错验证的记录。在有些情况下验证用的好件或坏件也要进行定期校准。Confirm that a list of error proofing devices is available. Confirm that themethod of the error proofing verification is defined and documented in thestandardized work.Verify that all error proofing devices are checked for function (failure orsimulated failure) at the beginning of the shift. Otherwise according to theprocess control plan.Look to see that error proofing masters (when used) are clearly identified.Confirm records of verification are available.Verify that a reaction plan is available in the event of error proofing devicefailure and is understood by the team member.0BIQS -7Gage Calibration / Measurement System AnalysisGage capability (e.g. gage R&R, bias, linearity, stability, etc.) ofmonitoring and measuring equipment is determined and theequipment is certified/calibrated at a scheduled frequency.对监控或者测量设备的能力（如测量设备的 R&R，偏移，线性，稳定性等等）进行了计算，并且量检具根据规定的周期进行定期校准。Evidence Gage R&R and certifications are completed on time per localprocedure.Check that no gages are past due for calibration.Write down 3 gage numbers at random and verify they are in the gage controlsystem and on some calibration schedule.0BIQS -8Fast Response Problem Solving ProcessMinimum criteria for initiating Fast Response is met. PlantManager ensures the applicability and the timely completion of theitems being tracked. Plant Staff level personnel actively participatein daily meeting. Required documents are reviewed (FastResponse Tracking Sheet, Problem Solving Document, PFMEA,Process control plan, standardized work, Layered audits etc.).Exit criteria with appropriate timing are defined for closing issues.There is read across of corrective actions to like operations.达到实施快速响应的最低标准。工厂经理确保被跟踪项目的适时完成情况。工厂管理层积极参与到每日例会中来。要求的文件得到回顾（快速相应跟踪表，问题解决文件， PFMEA， PCP， JES等等），在标准化文件没有修改之前，质量问题应添加到 JES背面。问题关闭的退出标准和时间要求要有明确定义纠正措施要横向展开到相似操作。Verify that the Fast Response process is used for all significant quality issues(customer/Visual Inspection station/GP12).Confirm that the Plant Management ensures the applicability and the timelycompletion of the items being tracked.Confirm that the plant staff level personnel actively participate in daily meetingVerify that the required documents are reviewed and updated (e.g. FastResponse tracking sheet, problem solving document, PFMEA, Process controlplan, standardized work, layered audits, lessons learned, etc.)Confirm that there is read across of corrective actions to like operations.0Error ProofingGage ControlFast ResponseGM CONFIDENTIAL 3/10/15BIQS -9Team Problem Solving ProcessA well developed, standardized problem solving process exists atall levels of the organization.Formal problem solving activities are initiated according to aspecified criteria.Issues are identified, root causes analyzed and robust actionscompleted in a timely manner.Problem solving is driven at the Team level and all Teams areinvolved. Leaders are actively involved coaching and guiding theprocess.1.有标准化的、完善的问题解决流程2.根据明确的标准启动正式的问题解决活动3.问题识别，根本原因分析和有效对策实施要及时4.推动问题解决的团队合作，各职能团队都加入到这个活动中。领导层也积极参与，以提供指导和帮助。To provide common methods for solving problems that are understood andused by all.A standardized problem solving process exists. A range of problem solvingactivities are conducted for different problem types and complexities, includingsingle (special) cause, common (repetitive) cause, as well as more complexmultiple-cause problems.Ask to talk through some problems with Team Leaders and Supervisors.Ask how many formal problem solving activities the team has worked on inrecent months?Look for all teams should be involved in problem solving activities.Look for a standardized process that includes: issue description and definition,containment, probable cause analysis, root cause analysis (5 Whys),countermeasures, implementation plan, verification, approval to close, andescalation or read across if needed.Look for Leadership involvement (reviews, coaching, escalation, support, readacross, etc.)0BIQS -10Quality Focused ChecksHigh risk items from Critical (Delta) operations have a QualityFocused check performed each shift.High risk quality focused items from customer feedback andproblem solving are included in the Quality Focused audit, or othersuitable checklist, and checked each shift.1.关键工艺的高风险项在每班都应进行质量关注检查。2.来自于客户反馈和问题解决的高风险项目应包含在质量关注检查中，或者其他合适的检查清单内，并且每班都进行检查。Look for high risk quality focused items from Fast Response, customerfeedback and problem solving to be included in the quality focused section ofthe layered audit, or other suitable checklist and checked each shift.Look for high risk quality focused items from Delta C operations to be includedin the quality focused section of the layered audit and checked each shift. 0BIQS -11Standardized WorkAll work is documented using a standard format and meets allsafety, quality and element time requirements.1.所有作业（循环重复作业和非循环重复作业）都要有文件化的标准方式以满足安全，质量和作业时间的要求。To establish a Standard to facilitate training and understanding ofdocumentation across the entire plant/organization.Use the plant approved documents to capture Standardized Work.Standardize Work Documents should include what, how & why for tasksperformed.Check if standardized work is available at the workstations and followed.0Standardized WorkGM CONFIDENTIAL 3/10/15BIQS -12Process Change ControlPlant processes are validated relative to changes in Design, Man,Machine, Material, Method and Environment. The plant follows adocumented change control process for customers and internalchanges. The PFMEA is updated to reflect any change, asrequired.与设计，人员，设备，物料，工艺和环境变化相关的过程得到充分验证。工厂遵循文件化的变化点控制流程， PFMEA根据需要结合变化点进行更新。Confirm that all plant changes are processed through the plant cross functionalprocess change approval system.Confirm if PTR is necessary.0BIQS -13Verification Station (Final Inspection /CARE / GP12)Final Inspection / GP12 must be conducted on all finished productprior to shipping. Can be 100% inspection or audit based on risk.All items checked in the Verification Station (Final Inspection/CARE / GP12) must be included in a check at an upstreamstation. Quality checks are included in standardized work. Point,touch, listen and count inspection methods are incorporated.Successive Production/Quality checks are increased in case ofhigh risks such as model launch, pass through components andcharacteristics pass through, major changes, shut down orcustomer feedback.1.要有专门的验证工位（比如工段检查工位 /终检工位/CARE/GP12）。2.根据风险可以是 100%检查，也可以是抽检。 CARE/GP12检查的项目不能是首次检查项目。检查过程要有标准化作业，可以结合用手指点、触摸、听、数数等方法。在风险较高时可能要增加检验项目或频次，比如项目开发阶段、 Pass through的零件、重要变更、停线或者有客户投诉。Confirm that Verification Station (Final Inspection /CARE / GP12) isimplemented per the local requirement.Look for point, touch, listen and count inspection methods incorporated intoquality checks. Look for increased quality checks for launch, shut down orbased on customer feedback (eg. Fast Response).0BIQS -14Change Control - Production Trial Run (PTR)The plant has regular meetings, including all departments, todiscuss upcoming changes (product engineering changes, plantprocess changes, supplier process changes) and coordinatePTRs. A reasonable sample size is used for Production Trial Run,based on risk. Changes are clearly communicated andunderstood at all levels (e.g. team level).Parts are contained, stored and clearly identified prior to and afterthe PTR build and PPAP approval.1.工厂有例会讨论近期的重要变更（设计变更，工艺变更，供应商工艺变更等），协调变更零件的生产试装。根据风险不同，确定试装零件的数量。变更内容要通知到生产相关的各个层级（比如班组），并得到充分理解。2.在 PTR前后及 PPAP批准前，变更零件要隔离存放并有明确标识。Confirm that the plant has regular meetings, including all departments, todiscuss upcoming changes and coordinate PTRs for customers or internalchanges.Look for a reasonable sample size to be used for Production Trial Run, basedon risk.Ensure changes are clearly communicated.Verify that parts are contained, stored and clearly identified prior to and after thePTR build.Confirm that for changes that require a customer PTR, all customer locationsare notified. Look to see that production breakpoints are recorded.0Managing ChangeGM CONFIDENTIAL 3/10/15BIQS -15Andon System ImplementationA well functioning Andon system is implemented in all productionareas to support the Team Member when abnormal conditionsoccur and communicate relevant information.All operational areas of the organization are using the Andonprocess as intended and this shows tangible results on the shopfloor.按灯系统在各个生产区域正常运转，目的是在出现异常时给员工提供帮助并沟通异常信息。所有区域的人员在使用按灯流程并在现场达到实际效果。The Andon system enables the Team Member to call for help and supports theconcept of “Do Not Accept, Build or Ship a Defect“. Andon calls can be radio,pager, stack lights, andon boards, etc.Check that the requirements of an effective Andon system are present in allproduction areas.Take a few operator stations in different areas as an example. Ask TeamMembers and Team Leaders how the Andon is working and validate theeffectiveness.0BIQS -16Alarm and EscalationNonconforming product has sufficie