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1、Summary Sheet68e793faa6ceca0c98da4c59bd6501f8.xlsx1 / 8Version: 10.0Revision date: 19/2/2018* *评评价价方方法法 :/ / HowHow toto ScoreScore : :绿色:建立了完善、有效的质量系统或过程,并按要求运行,系统或过程不会使SGM面临不必要的风险;Green: A mature, well-defined, quality system or process is in place, being followed/utilized as directed, and the sys

2、tem or process does not place GM at unnecessary risk.黄色:质量系统或过程不完善或未完全按要求运行;Yellow: Quality system or process is in place, but is not followed/utilized as intended.红色:质量系统或过程定义有缺失,或目前的系统或过程会使SGM面临重大风险;Red: Quality system or process is not evident, or the current system or process in place puts GM at

3、 significant risk.Safety is not used to calculated BIQS Level score.供供应应商商/Supplier/Supplier:0DUNs #:0#模模块块/Statement/StatementAUDITSCORE纠纠正正措措施施/Countermeasures/CountermeasuresTargetDateDateCompleted优优先先级级PRIORITYPRIORITYBIQS -1合格/不合格物料区分Nonconforming Material / Material IdentificationGBIQS-2分层审核La

4、yered AuditGBIQS-3PFMEAsGBIQS-4PFMEAs - 风险降低和年度回顾PFMEAs -Risk Reduction & Annual ReviewGBIQS-5临时替代/偏差管理Bypass / Deviation Management GBIQS-6防错验证Error proofing/ Detection VerificationGBIQS-7量具校准及测量系统分析Gage Calibration / Measurement System AnalysisGBIQS-8快速响应Fast Response ProcessGBIQS-9团队合作解决问题Tea

5、m Problem Solving ProcessGBIQS-10质量关注点检查Quality Focused Checks GBIQS-11标准化操作Standardized WorkGBIQS-12变更管理Process Change Control GBIQS-13质量门(验证岗位/终检/CARE/GP12)Inspection Gates (Verification station /Final Inspection/ CARE/ GP12) GBIQS-14变更管理-生产试运行Change Control - Production Trial Run (PTR)GBIQS-15暗灯系

6、统Andon System ImplementationGBIQS-16报警与升级Alarm and EscalationGBIQS-17感官检验(目视/触摸/听等)Visual Controls GBIQS-18感官检验标准-沟通和理解Visual Standards - Communicated and UnderstoodGBIQS-19过程控制管理 - PFMEA过程控制计划-作业指导书Development Of Process Controls (PFMEA-PCP-SW)GBIQS-20按过程控制计划要求实施Process Control Plan ImplementedYBIQ

7、S-21过程能力研究Process Capability ReviewYBIQS-22返工返修Rework / Repair ConfirmationYBIQS-23前馈后馈Feedback / FeedforwardYBIQS-24培训TrainingYBIQS-25异物管理Contamination RequirementsYBIQS-26维护保养MaintenanceYBIQS-27先进先出/物料搬运过程FIFO / Material Handling ProcessYBIQS-28认可的发运包装Shipping Approved Packaging YBIQS-29分供方管理Suppl

8、y ManagementYBIQS Audit Pg 168e793faa6ceca0c98da4c59bd6501f8.xlsx2 / 8Version: 10.0Revision date: 19/2/2018GM 1927-30 BIQS AssessmentVersion: 10.0Issue Date: 19/2/2018供供应应商商名名称称:Supplier:Supplier:安安全全评评审审:SafetySafety Concerns:Concerns:*BIQS*BIQS 3030 不不计计入入BIQSBIQS 审审核核评评分分*BIQS 30 is not used to c

9、alculate BIQS ScoreBIQSBIQS审审核核评评分分等等级级:BIQSBIQSAuditAudit Level:Level:工工厂厂地地址址:Location:Location:审审核核员员:AuditorAuditor Name:Name:3制制造造地地SUNsSUNs:DUNS:DUNS:Y审审核核日日期期:AuditAudit Date:Date:BIQS Score:66%Total Elements:29Number of Green:19Number of Yellow:10Number of Red:0问问题题解解决决有有效效性性:(查查阅阅相相关关看看板板或或

10、内内外外部部问问题题清清单单,选选择择1-31-3个个已已关关闭闭的的问问题题,按按如如下下清清单单条条款款进进行行核核查查)PROBLEM SOLVING CLOSURE EFFECTIVENESS: ( Review board or log file and select 1-3 closed issues as per below details )供供应应商商处处案案例例编编号号QUALITYQUALITY ISSUEISSUE # #案案例例内内容容摘摘录录ISSUEISSUE DESCRIPTIONDESCRIPTION1快快速速响响应应FASTFAST RESPONSERESP

11、ONSE PROCESSPROCESS USEDUSED2遏遏制制表表应应用用DEPTDEPT CONTAINMENTCONTAINMENT WORKSHEETWORKSHEET USEDUSED3发发布布质质量量警警示示QUALITYQUALITY ALERTALERT POSTEDPOSTED4加加入入CARE/GP12CARE/GP12ADDEDADDED TOTO CARECARE / / GP12GP125完完成成问问题题解解决决PROBLEMPROBLEM SOLVINGSOLVING FORMFORM COMPLETECOMPLETE6加加入入分分层层审审核核ADDEDADDED

12、 TOTO LAYEREDLAYERED AUDITAUDIT7问问题题解解决决有有效效性性CORRECTIVECORRECTIVE ACTIONACTION EFFECTIVENESSEFFECTIVENESSMONITOREDMONITORED8防防错错应应用用ERRORERROR PROOFEDPROOFED9防防错错验验证证ERRORERROR PROOFINGPROOFING VERIFICATIONVERIFICATIONCOMPLETECOMPLETE10FMEAFMEA 更更新新FMEAFMEA UPDATEDUPDATED 11控控制制计计划划更更新新CONTROLCONTR

13、OL PLANPLAN UPDATEDUPDATED12标标准准化化操操作作更更新新STANDARDIZEDSTANDARDIZED WORKWORK UPDATEDUPDATED13培培训训实实施施TRAININGTRAINING COMPLETEDCOMPLETED14区区域域标标识识/ /不不合合格格品品隔隔离离GENERALGENERAL AREAAREA TAGGINGTAGGING / / NCNC MATLMATLSEGREGATIONSEGREGATION15工工程程变变更更/ /工工程程变变更更实实施施ENGINEERINGENGINEERING CHANGECHANGE R

14、EQUESTREQUEST / /PROCESSPROCESS CHANGECHANGE REQUESTREQUEST16PTRPTR 实实施施PTRPTR CONDUCTEDCONDUCTED17横横向向展展开开READREAD ACROSSACROSS TOTO SIMILARSIMILAR LINESLINES / /PROCESSESPROCESSES18再再发发风风险险CHANCESCHANCES OFOF RECURRENCERECURRENCE * * 说说明明 - - 抽抽取取3 3个个已已关关闭闭的的问问题题(来来源源于于供供应应商商不不同同工工厂厂/ /产产品品),按按上上

15、表表要要求求通通过过逐逐项项核核查查来来确确认认问问题题解解决决的的有有效效性性;* 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.* *供供应应商商 - - 需需要要预预先先准准备备好好相相关关问问题题清清单单、所所有有对对应应问问题题的的完完整整解解决决报报告告(

16、含含问问题题解解决决过过程程和和关关闭闭的的所所有有证证明明材材料料),以以支支持持对对问问题题解解决决过过程程有有效效性性的的评评审审;* Supplier: Be prepared to show documentation/evidence that supports completion of the key components of effective problem solving identified in the chart above.X= 不符合/Noncompliant O= 符合/CompliantN/A= 不适用/Not ApplicableBIQS Audit P

17、g 268e793faa6ceca0c98da4c59bd6501f8.xlsx3 / 8Version: 10.0Revision date: 19/2/2018BIQSItem #BIQSBIQS 要要求求/ / RequirementRequirementBIQSBIQS 审审核核参参考考(核核查查内内容容)/Calibrator/Calibrator GuidelinesGuidelines (Look(Look For)For)结结论论ScoreScore记记录录/Comments/Comments* * HowHow toto ScoreScore / / 评评价价方方法法 :Gr

18、een: A mature, well-defined, quality system or process is in place, being followed/utilized as directed, and the system or process does not place GM at unnecessary risk.绿色:建立了完善、有效的质量系统或过程,并按要求运行,系统或过程不会使SGM面临不必要的风险;Yellow: Quality system or process is in place, but is not followed/utilized as inten

19、ded.黄色:质量系统或过程不完善或未完全按要求运行;Red: Quality system or process is not evident, or the current system or process in place puts GM at significant risk.Safety is not used to calculated BIQS Level score.红色:质量系统或过程定义有缺失,或目前的系统或过程会使SGM面临重大风险;BIQS 30 is not used to calculated BIQS Level score.BIQS 30 不计入评分;合合格格

20、/ /不不合合格格物物料料的的区区分分 NonconformingNonconforming MaterialMaterial / / MaterialMaterial IdentificationIdentificationBIQS -1合合格格/ /不不合合格格物物料料的的区区分分NonconformingNonconforming MaterialMaterial / / MaterialMaterial IdentificationIdentification有不合格物料的处理流程,员工理解如何处理不合格/可疑物料并遵守。Team members have standardized w

21、ork and understand what to do with nonconforming / suspect material.合格物料的堆放、存储和标识符合要求。Conforming material is handled, stored and identified appropriately.不合格品/可疑品被清晰的标识和/或有效的隔离( 如 红、黄、绿颜色标识的有效使用)。Non conforming / suspect material is clearly identified and/or segregated forreview/disposition (i.e. ap

22、propriate color coding for foot printing red, yellow,green).有发布的遏制流程来确保建立有效的遏制断点。有相关的遏制行动和结果记录。A containment method is in place to ensure that an effective breakpoint hasbeen established. Containment activities and results are documented.按照产品的追溯要求建立了追溯方法,对返工件也有相应追溯(如需)。Traceability is applied accord

23、ing to the traceability methods of the finishedproduct , and reworked parts when needed .现场核查确认员工理解如何处理不合格/可疑零件。Sample audit to verify that team members understand what to do with nonconforming / suspect material.确认合格物料的堆放、存储和标识是有效的。Confirm that conforming material is handled, stored and identified

24、appropriately.确认不合格/可疑物料被清晰的标识和/或有效的隔离,有效应用红黄绿色标进行标识、定位和隔离。Confirm that nonconforming / suspect material is clearly identified and/or segregated. Red, Yellow, Greenstoplight approach is adhered to for foot printing, containerization, table marking and tagging.确认过程中所有被移出的产品都被有效标识和/或隔离,能避免被错误使用并记入FTQ,

25、。Audit that all parts removed from the process are identified, accounted for (FTQ), and reconciled to eliminatemishandling of material.确认使用区域遏制工作表,对零件可能存储的所有区域(包含临时存储区域)进行了遏制。遏制范围必须涵盖从进料,加工到发运的全部过程。Verify use of Department Containment Worksheets, with potential parts locations by operation identifie

26、d toensure no parts are missed during a containment and all parts are reconciled. The containment worksheetsmust cover from the incoming material, process and shipment.报废或可疑物料与正常物料必须有效隔离。Scrap or Suspect parts/containers clearly segregated from other parts.自动剔除工位剔除的零件不能被随意取出,隔离物料的取出须有相应的管控方法以避免被错误使用

27、。Auto Reject stations with Locked reject bins, with controls on how bins are emptied to ensure all parts arereconciled.物料应该被物理性标记(如贴标签、划标识等)或喷漆,除非能通过其他方法(如电子系统)有效识别,避免被错误使用。Parts should be physically tagged or painted unless ensured by different process such as e-system foridentification purposes an

28、d to drive a physical act during handling, which will reduce the chances of mis-handling parts.G分分层层审审核核 / / LayeredLayered AuditAuditBIQS -2分分层层审审核核/Layered/Layered AuditAudit有分层审核流程并有效实施,确认过程控制的符合性,识别持续改进的机会,建立与员工间言传身教的互动。Layered audits are in place to assess compliance to standardized processes,i

29、dentify opportunities for continuous improvement , and provides coachingopportunities.管理层负责分层审核的实施,每一级管理层都应参加分层审核。Layered audit process is owned by Management. Audit plan shall includemultiple levels of Management.分层审核有效实施并有完整记录。Audits are tracked and their results recorded.审核发现的所有不符合项的整改必须被有效跟踪。Fol

30、low up to address non compliance is in place.分层审核是确认过程控制符合要求并识别持续改进机会的有效工具。 Layered Audit is an effective tool to confirm the processes are operating at standard, and enhancecontinuous improvement.管理层通过现场审核来确认过程控制有效、员工技能和行为符合,对正确有效的行为予以肯定。通过言传身教的互动加强与员工的交流。Leadership utilizes an audit process by goi

31、ng and seeing on the shop floor to check process compliance,employee behavior and knowledge. Leadership uses Layered Audit as an opportunity for coaching.Recognition is used to reinforce the right behaviors.核查分层审核实施层级、关联的人员和设定的审核频次符合要求。Ask Leadership how Layered Audit works in the organization, who

32、is involved in the layered audit process,what is the frequency of layered audits.核查分层审核表的内容是否适用(不同层级人员的审核要求设定)?通过定期不定期的更新审核要求来持续关注现场的薄弱点。Is the layered audit sheet content relevant for the user (have each principle calibrator review respective part ofthe audit sheet)? Layered audit questions are rev

33、iewed from time to time to focus on the plant weaknesses.审核发现的所有问题都必须记录在审核发现问题清单内,当班内不能解决的问题必须传递到下一班次持续解决。核查分层审核人员的审核方法并对比其审核结果与现场实际状态的一致性。Check that all findings are recorded on the audit sheet and those not solved within the shift are transferred tocountermeasure sheets. Interview auditors how the

34、y perform audit and compare results with shop floor majorfindings . G风风险险管管理理 / / ManagingManaging RiskRiskBIQS -3PFMEAs运用最新版PFMEA对所有生产过程进行风险分析。PFMEA必须由包括制造团队成员在内的多功能团队联合完成。基于严重度、发生频次和探测度建立风险评估和识别方法(不能优先使用RPN值),并用于PFMEA持续改进。All operations have been analyzed for risk using a PFMEA.PFMEA workshops mus

35、t be done by cross functional teams, includingmanufacturing team member input. The suppliers shall set up related riskevaluation sheets based on Severity, Occurrence and Detection to reduce therisk continuesly, but can not use Risk Priority Number (RPN) values first.在PFMEA中正确识别所有可能失效模式(如用错零件、混料、异物控制

36、等),PFMEA文件的描述正确。Failure modes are comprehended in the PFMEA (i.e. wrong parts, mixed parts,containment control, etc.).PFMEA has correct structure .对所有的生产操作都进行了的PFMEA分析,PFMEA是由由包括制造团队成员在内的多功能团队联合完成的。有风险评估和排序方法(不优先使用RPN值)进行PFMEA风险评估和持续改进。Look for PFMEAs to be available for all operations within the pl

37、ant. Confirm PFMEA workshops are done bycross functional teams, including mfg. team member input. Confirm use the risk evaluation sheets based onSeverity, Occurrence and Detection to reduce the risk continuesly, but can not use RPN values first.确认PFMEA文件覆盖了所有的生产操作,特别关注对标识、搬运等操作的PFMEA分析。确认PFMEA文件描述包括

38、正确的产品要求、基于失效模式的各种可能原因。严重度评估涵盖了对所有客户的影响,包括工厂内部、客户和最终用户。Confirm That PFMEA include all operations and make sure that labeling, handling, etc. are included.Check that PFMEA structure includes product requirements, multiple causes for failure modes whereapplicable. Severity is studied based on all risks

39、 such as plant risk, customer risk, and end user risk . GBIQS -4PFMEAsPFMEAs - - 风风险险降降低低和和年年度度回回顾顾PFMEAsPFMEAs - - RiskRisk ReductionReduction & & AnnualAnnual ReviewReview定期开展风险降低持续改进活动来避免缺陷流出工序。 Monthly RPN risk reduction reviews by product focused on preventing defectsfrom leaving the wo

40、rk station are held to drive continuous improvement.对优先改进项的行动方案应包括:1、建议措施,2、责任人,3、相关时间计划。Action plans for top issues must include: 1. Recommended actions, 2.Responsibility, 3. Timing.定期在生产现场进行逆向PFMEA检查以识别新的潜在失效模式。Reverse PFMEA process is in place to identify new potential failure mode in theshop flo

41、or.寻找定期开展风险降低持续改进活动来避免缺陷流出工序活动的证据。Look for evidence of monthly cross functional risk reduction reviews focused on preventing defects fromleaving the work station.确认对优先改进项的行动方案包括:1、建议措施,2、责任人,3、相关时间计划。Confirm action plans for top issues include: 1) Recommended actions, 2) Responsibility, 3) Timing.确认

42、是否有风险顺序评估/排序方法来识别优先改进项目。Check if there is a process of prioritizing high risk items such as Risk limiting method or equivalent.工厂管理层必须参与优先改进项的风险降低活动并批准相应措施。Plant Management shall be included in top risk reporting and approval of countermeasures.验证逆向PFMEA发现的问题是否已整改完成并体现在相应的过程流程图、PFMEA、控制计划和作业指导书中。Ver

43、ify if Reverse PFMEA (On-station reviews) findings are driven back into the Process Flow, PFMEA, ControlPlan, and Work Instructions as applicable.GBIQS -5临临时时替替代代/ /偏偏差差管管理理BypassBypass / / DeviationDeviation ManagementManagement工厂应识别可临时替代或偏差接受的装置。对所有批准的临时替代/偏差接受方案,要进行风险评估并建立完整的作业指导书The plant shall

44、identify manufacturing processes and error proofing deviceswhich can be bypassed or placed in deviation. Risk Priority Number (RPN) forall approved Bypass / deviation processes are evaluated and risks are reviewed.Standard work instructions are available for each Bypass / deviation process.定期回顾已实施的临

45、时替代/偏差管理活动来寻求降低或消除再次实施的可能性。Implemented Bypass is reviewed regularly and goal is reduce or eliminatebypass .核查工厂批准的可实施临时替代或偏差接受的装置清单。Look for the plant list of manufacturing processes and error proofing devices which can be bypassed or placedin deviation.确认对所有批准的临时替代/偏差接受方案都进行了风险评估,并建立了完整的作业指导书。 Conf

46、irm that Risk Priority Number (RPN) for all approved bypass / deviation processes are evaluated and thatStandardized Work is available for each bypass/deviation process. 该临时替代/偏差接受方案应得到包含顾客在内的书面批准。Supplier locations shall have a written and approved bypass/deviation procedure that includes customern

47、otification.核查是否定期回顾/检查临时替代/偏差管理方案以寻求降低或消除实施的可能性。Check how bypass is reviewed regularly and check if the has a goal to reduce or eliminate bypass .G611 16 21 261BIQS Audit Pg 268e793faa6ceca0c98da4c59bd6501f8.xlsx4 / 8Version: 10.0Revision date: 19/2/2018Error ProofingBIQS -6防防错错验验证证/Error/Error pro

48、ofingproofing /Detection/Detection VerificationVerification每班开机前对所有的防错装置进行功能(失效或模拟失效)检查,以确认防错功能有效,如失效按过程控制计划的反应计划实施。All Error Proofing Devices are checked for function (failure or simulated failure)at the beginning of the shift. Otherwise according to the process control plan.防错样件要有清晰标识,要保留防错验证的记录。防

49、错失效的行动计划应标准化并易于理解。Error Proofing Masters/Challenge parts (when used) are clearly identified.Records of verification are available. Reaction plan is standardized andunderstood in case of error proofing devices malfunction做好防错样件管理与校准(如需)。When applicable the rabbits part are calibrated.有防错装置清单。Confirm

50、that a list of error proofing devices is available.有防错装置验证标准化作业文件。Confirm that the method of the error proofing verification is defined and documented in the standardizedwork.确认每班开机前对所有的防错装置进行了防错验证。Verify that all error proofing devices are checked for function (failure or simulated failure) at the

51、beginning ofthe shift. Otherwise according to the process control plan.确认防错样件被清晰标识,有效管理。Look to see that error proofing masters (when used) are clearly identified. Confirm records of verification areavailable.确认有团队成员理解的包含遏制措施的反应计划。Verify that a reaction plan is available and make sure it include con

52、tainment in the event of error proofingdevice failure and is understood by the team member.GGage ControlBIQS -7量量具具校校准准及及测测量量系系统统分分析析GageGage CalibrationCalibration / / MeasurementMeasurement SystemSystem AnalysisAnalysis受控管理测量装置,定期进行测量系统分析(如R&R、偏移、线性、稳定性等)、测量装置检定/校验。Gage capability (e.g. gage R

53、&R, bias, linearity, stability, etc.) of monitoring andmeasuring equipment is determined and the equipment is certified/calibratedat a scheduled frequency. 按管理规定有效进行MSA(如R&R)和周期检定。确认结果符合或对不符合的结果采取行动。Evidence MSA such as Gage R&R and certifications are completed on time per local procedur

54、e. Check thatresults are studied and action taken if results is not satisfactory.MSA应涵盖对应量具涉及的所有特性MSA should cover all characteristic that the gage control/measure.所有量检具在检定有效期内。Check that no gages are past due for calibration.所有量检具受控管理。Check that system in place to monitor and follow up all gauges t

55、o ensure control of all devices calibration.现场随机抽取3个量检具来验证其是否被受控管理并按周期检定合格。Write down 3 gage numbers at random and verify they are in the gage control system and on some calibrationschedule.GFast ResponseBIQS -8快快速速响响应应 / / FastFast ResponseResponse ProcessProcess符合快速响应的最低要求Minimum criteria for init

56、iating Fast Response is met.工厂管理层应确保问题被定期的跟踪。工厂管理层积极参加每日会议并跟踪审核相关文件(如快反看板、问题解决报告、PFMEA、控制计划、标准化作业文件、分层审核等)。Plant Manager ensures the applicability and the timely completion of the itemsbeing tracked. Plant Staff level personnel actively participate in daily meeting.Required documents are reviewed (F

57、ast Response Tracking Sheet, ProblemSolving Document, PFMEA, Process control plan, standardized work, Layeredaudits etc.).明确定义问题关闭的退出条件和时间计划。Exit criteria with appropriate timing are defined for closing issues.纠正措施横向展开和经验教训总结There is read across of corrective actions to like operations.所有重大质量问题上升到快反

58、会议(客户抱怨、感官检验工位、GP12)。回顾看板或问题清单,选择3个已经关闭的问题核查问题解决和关闭有效性(按Pg1要求进行评估)Verify that the Fast Response process is used for all significant quality issues (customer/Visual Inspectionstation/GP12). Review the board or the log file and select 3 closed problem to check how they are closed(Evaluate fast respons

59、e problems on Pg. 1 of this document).确认工厂管理层有效参与了问题解决过程的跟踪。Confirm that the Plant Management ensures the applicability and the timely completion of the items beingtracked.确认工厂管理层积极参加每日会议并跟踪审核相关文件Confirm that the plant staff level personnel actively participate in daily meeting and confirm that natu

60、ral owneris assigned for FR issues .确认相关文件被评审并更新(如快反看板、问题解决报告、PFMEA、控制计划、标准化作业文件、分层审核等)。Verify that the required documents are reviewed and updated (e.g. Fast Response tracking sheet, problemsolving document, PFMEA, Process control plan, standardized work, layered audits, lessons learned, etc.)确认进行了纠正措施的横向展开和经验教训总结。Confirm t

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