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Rating:NA=NotApplicable,NI=NeedsImprovement,AD=Adequate,ER=ExceedsRequirementsQUALITYMANAGEMEA NTTheQAorganization'sresponsibilitiesareA-1clearlydefinedinwriting,reflectedinaQualityManualandhasclearauthoritytowithholditemsnot
SUPPLIERAUDITCHECKLIST
Page2of____ComDegreplianeofceImpleRatinmentagFulltionWeightedScore None NI AD ER ScoreYes No NA (FS)15 0 4 6 8 9 11 13 14 15meetingacceptablequalitystandards品质保证组织的职责以书面形式明确定义,并反映在品质手册中;品质保证组织有权停止不符合质量标准的项目。ThereisQAManualandrevisionhistoryA-2reveals100345678910continuouupdateandreviewwithinthe品质保证手册和历史版本能体现出一年内的持续更新和评审。TheQAorganizationoperatesadefectA-3preventioprogramthatincludesdefectanalysisandthe20068101214161820generationofimprovementactions品质保证组织推行包括了缺陷分析和改善行动的缺陷预防计划TheQAorganizationpreparesandissuesA-4periodicreportsandmaintainsrecordsrelativetoprocess20068101214161820controlandoutgoinginspectionyields,topqualityproblemsanditscountermeasures,customercomplaintanddefectratesinPartsPerMillionterms品质保证组织准备和发行定期的报告和维护与过程控制、出货检验、主要的品质问题和对策、客户投诉、PPM不良率相关的记录QualityperformancetargetsareA-5clearlyandcontinuouslydevelopedandmonitoredfor20068101214161820improvements质量目标明确定义并持续提高,并为改善而监控。TOTALRATIN85PROCUREMENTCONTRBOLThereisaprocedureandrecordstoshowthatB-1thereis20068101214161820anadequatesupplierqualificationprocess.有程序文件和记录表明存在适当的供应商评估过程。AnApprovedVendorList(AVL)isavailableB-2and20068101214161820properlycontrolledandhassysteminplacetopreventunauthorizedpurchasefromunapproved有完全受控的AVL,并有系统防止未经授权从非合格供应商处采购的行为。ThereisaprocedureandrecordsavailableB-3showing20068101214161820anadequatesupplierratingsystem.有程序文件和记录表明存在适当的供应商分级系统。ThereisasystemforsuppliercorrectiveB-4action150468911131415requestsandtherearerecordstoshowthatsupplierresponsesareanalyzedandcloselymonitored.有系统支持供应商改善行动要求并有记录表明对供应商的反馈进行了分析和有效监控。TOTALRATIN75INCOMINGMATERIALCONTRC OLAlegitimateandformalisedreceivinginspectionC-1isavailablethatchecksincomingshipmentsto20068101214161820purchaseorderrequirements,referencequalityspecifications,andapplicabledrawings.有合理和规范的来料检验,根据定单要求、相关质量规范和图纸对来料进行检查。SUPPLIERAUDITCHECKLISTRating:NA=NotApplicable,NI=NeedsImprovement,AD=Adequate,ER=ExceedsRequirementsINCOMINGMATERIALCONTRC OLRequiredinspectionandtestarebeingdoneC-2includinguseofappropriateequipmentsandinstruments.要求的检验和测试已严格执行,包括使用适当的仪器和设备。InspectedmaterialisadequatelyC-3identifiedacceptancorrejectionandtraceabletoreceiving
Page3of____ComDegreplianeofceImpleRatinmentagFulltionWeightedScore None NI AD ER ScoreYes No NA (FS)25 0 8 10 12 14 18 22 23 2520 0 6 8 10 12 14 16 18 20inspectionreport.检验过的物料状态(接收/拒收)能明确区分并能追溯到检验报告。ControlsareadequatetoprevententryofuninspectC-4edstockand/orrejectedmaterialintostock.有充分的控制措施防止未经检验或拒收的物料进入库房。TherearerecordsavailabletoindicatethatC-5incomingmaterialqualityperformanceisbeingmeasuredandanalyzedandevidenceshowingactionsarebeingtakentocontinuouslyimproveperformance.有记录证明来料的质量表现已经过测量和分析,并有证据证明已采取持续改善表现的行动。ReceivinginspectionpersonnelhaveQAC-6controlled
10 0 3 4 5 6 7 8 9 1020 0 6 8 10 12 14 16 18 20instructionsdefiningcharacteristics,equipmen100345678910andmethodsusedduringinspection.检验员有受控的作业指导书指导,指导书内容包括了检验的项目、设备和方法。TOTALRATIN105NON-CONFORMINGMATERIALCONTROLThereisanadequatesystemtoensureproperD-1control20068101214161820ofpartsfailedorrejectedinproductionincludingre-inspectionorre-testingofreworkedparts.有适当的系统确保生产中的失效和拒收品完全受控,包括对返工品的重新检验和测试。Non-conformingmaterialsfoundinProductioD-2nareverified,analyzedandimprovementactionsare20068101214161820generatedonacontinuousbasis.在生产中发现的不合格物料经过确认、分析并在持续的基础上推进改善活动。Non-conformingmaterialsareproperlyD-3identified20068101214161820andsegregatedfromgoodmaterial.不合格物料能明确区分并与合格物料隔离。AdequatecontrolsareinplacetopreventunauthoriD-4zeuseofsensitiveorcriticalnon-conformingraw20068101214161820materials.有充分的控制措施防止未经授权而使用敏感或重要的不合格原材料。Useofnon-conformingmaterialisdocumentD-5edunderaformalwaiverorconcessionsystemandcovered20068101214161820byaformalprocedure.对不合格物料的使用必须按规范的程序取得让步接收的正式文件。ThereisaMaterialReviewBoardorequivalentD-6body150468911131415thatregularlymeetstomakedispositionsonnon-conformingmaterials.有物料评审会议或相当的实体有规律的处理不合格物料。Thereisasystemin-placetoensureproductD-7records300812161821262830traceabilitythatwillfacilitateproblemandcorrectiveactions.有系统保证产品记录的可追溯性便于问题的评估和改善。TOTALRATIN145SUPPLIERAUDITCHECKLISTRating:NA=NotApplicable,NI=NeedsImprovement,AD=Adequate,ER=ExceedsRequirementsINPROCESSCONTRE OLManufacturingorQCpersonnelhaveavailableE-1ateachoperationsuptodateinstructionsthatandidentifiesthecharacteristicstobemonitoredbysamplesize,frequencyandmethod.制造和检验人员的所有操作均有最新的作业指导
Page4of____ComDegreplianeofceImpleRatinmentagFulltionWeightedScore None NI AD ER ScoreYes No NA (FS)30 0 8 12 16 18 21 26 28 30书,作业指导书有时间规定并明确了项目和监控的抽样数、频次和方法。ThereisaProcessQualityControlPlanthatE-2showsthecompleteprocess,criticalinspectionpoints,20068101214161820frequencytypeofrecords,responsibility,testandproductionequipment.有过程控制计划标明所有的过程、关键检验点、频次、记录种类、职责、测试和生产设备。Thesystemhasbatchrecords,tags,stamps,E-3travellers,tocontrolandindicatetheinspectionorprocess20068101214161820statusduringwork-in-process.系统中有批次记录、标签、图章、传送器等控制和标识生产中的检验和过程状态。In-processcontroldataisrecordedandmaintaineE-4dtoquantifydefectratesforcritical在线控制数据有记录并用于计算关键工序的缺陷率。In-processqualitydefectratesareingeneralE-5withinnormalacceptabllimitsindicativeofastableandconsistentqualityproductsandprocesses.在线缺陷率一般在正常可接受范围内并能体现产品和过程的稳定和一致。Reworksandscrapratesaretracked,E-6identifiescausalfactorsandhasinplacecorrectiveactionproceduretocontinuallymonitorprogress跟踪返工和清线的比例,确定产生原因并有适当的改善程序持续监控和推进。
20 0 6 8 10 12 14 16 18 2040 0 12 16 20 24 28 32 36 4020 0 6 8 10 12 14 16 18 20TOTALRATIN150STATISTICALPROCESSCONTRF OLThereareprocedureandrecordsavailableF-1toindicatethatacompany-wideSPCprogramisadequatelyand20068101214161820effectivelybeingimplementedtoensureconsistentandreliableproducts.有程序和记录证明全公司范围的SPC技术运用充分和有效的实施,从而确保产品的一致和可靠。CriticalpartandprocessparametersareF-2being250810121418222325identifiedandappropriatestatisticalchartsarebeingusedtomonitorandcontrolprocessvariations明确了关键部件和过程的参数并通过适当的统计图表监控过程变化。WrittenplansforimprovementarebeingF-3generatedtoreducesourcesofvariation.已制定针对减少变化诱因的书面改善计划。Out-of-controlconditions(includingdataF-4pointsoutsidethenormaldistributionthatarewithinspecificationlimits)arebeingnotedonchartsdocumentedcorrectiveactionistakentobringtheprocessbackintocontrol.失控的情况(包括参数未超限但分布异常)在图中明确标注,并有文件化的改善措施使过程恢复受控状态。SUPPLIERAUDITCHECKLIST
20 0 6 8 10 12 14 16 18 2020 0 6 8 10 12 14 16 18 20Rating:NS=NotSatisfactory,NI=NeedsImprovement,AD=Adequate,ER=ExceedsRequirementsSTATISTICALPROCESSCONTRF OLMachineorprocesscapabilitystudiesF-5(Cpk)arebeingconductedonaregularbasisusing1.33Cpkorbetterasminimumtarget.定期进行设备或过程能力Cpk)进行分析,使用1.33或更好的指标作为最低目标。
Page5of____ComDegreplianeofceImpleRatinmentagFulltionWeightedScore None NI AD ER ScoreYes No NA (FS)20 0 6 8 10 12 14 16 18 20SuppliercanprovidecontinuousparametricF-6statistical250810121418222325dataasrequestedonaperiodicorlot/batchbasisthatwillshowthatthepartswereproducedunderstatisticallycontrolledprocessconditions.供应商能按要求提供连续的参数统计数据,定期或按批次的数据表明部件的生产处于稳定或统计受控的过程状态下。SPCandProcessCapabilityStudiesrecordsF-7are20068101214161820availableincludingdemographiclistofallCriticalParametersofacompleteprocessandshowingCpkvaluesupdatedregularly.能提供统计过程控制和过程能力分析记录,包括一个完整过程中所有关键参数的清单和Cpk值的定期更新。TOTALRATIN150SPECIFICATIONASSURANCEGANDRELIABILITYTESTINGTherequiredtestsorinspectionsarebeingdoneG-1under300812161821262830requiredconditionsandhasin-housecapabilityorequipmentstoperformsuchtestsorinspections.要求的测试和检验均在规定的条件下实施,有能力和设备实施要求的测试和检验。AreliabilitytestplanperproductisavailableG-2and300812161821262830adequatetomeetAvansys'srequirements.有每一产品的可靠性试验计划,计划满足安圣要求。ComponentreliabilitytestdataisavailableG-3upon20068101214161820requestandhistoricaltestperformancedatashowsahighlystableprocessandcomponentdesign.可提供按要求实施的元器件可靠性测试数据,历史测试表现表明过程和元器件设计的高度稳定性。ReliabilitytestfailuresareanalyzedandpermanenG-4t250810121418222325correctiveactionsaregeneratedtoimproveand/orcomponentdesign.可靠性测试失效样品经过了分析并据此进行了持久的改善活动改进过程或元器件设计。TOTALRATIN105CALIBRATIONCONTRH OLThereisaprocedureforinstrumentandH-1equipmen20068101214161820calibratiotoensureproductandprocessparametricmeasurementaccuracy.有仪器和设备的校准程序确保产品和过程参数测量的准确性。GagesandtestequipmentoutofcalibratioH-2n150468911131415aresegregated,andcontrolledtoprecludetheiruse.超过计量精度要求的量具和测试设备进行隔离,有控制措施防止其使用。GagesandtestequipmenhavestickersH-3affixedorequivalentmethod,indicatinglastdateofcalibration100345678910andduedateofcalibration量具和测试设备有标签或其他方法标识其上次校准日期和下次应校准的日期。GagesandtestequipmentarecalibratedH-4againstmeasuringstandardstraceabletolocalorforeign20068101214161820recognizedcalibratioagencyandcertifieddocumentsarekeptonfile.量具和测试设备的校验标准可溯源到国家和国际认可的机构,鉴定文件归档保存。SUPPLIERAUDITCHECKLISTRating:NS=NotSatisfactory,NI=NeedsImprovement,AD=Adequate,ER=ExceedsRequirements
Page6of____ComDegreplianeofceImpleRatinmentagFulltionWeightedCALIBRATIONCONTRHOLScoreNoneNIADERScoreYesNoNA(FS)ThereisadequatecalibratiorecallsystemH-5includinginstrumentsandequipmentmasterliststhatare20068101214161820documentcontrolandshowingcurrentcalibrationstatusofeachinstrumentand/orequipment.有校准反馈系统,包括受控并标明所有仪器设备校准状态的仪器和设备总台帐。BothinternalandexternalcalibratioH-6nrecords20068101214161820includingthosedonebyathirdpartyareandmaintainedforrecordstraceabilityandcontrol.可提供内部和外部包括第三方的校准记录,记录的管理受控并可追溯。AllgoldensamplesorreferencetestorH-7inspection100345678910standardsarecontrolledandunderperiodiccheckormaintenance.所有的校准样品、测试检验标准受控并定期检查和维护。TOTALRATIN115FINALINSPECI TIONGeneralprocedureforFinalInspectionisI-1 availableincludingspecifictestorinspectioninstructions.可提供通用的最终检验程序包括特性测试或检验的操作指导。Finalinspectionreportsaremaintained,includedI-2 intheshipmentsasrequiredandtraceablebothtoinspectorandlotinspectedcurrentlyinstorageoralreadyshipped.最终检验报告合理保存,包括出货时要求的,可追溯到检验者和目前在库的检验批次及已出货产品。
25 0 8 10 12 14 17 22 23 2520 0 6 8 10 12 14 16 18 20Thereisasystemtocontrollow-yieldlots,I-3including20068101214161820customernotificationwhenshippedandrelatedreliabilitytestdataisavailableuponrequest.有系统对低合格率批次进行控制,包括发运后对客户的通知和按要求提供相关可靠性测试数据。AproceduretoretrievedefectivelotsthatI-4mayhave20068101214161820beenshipped,whichincludesnotificatiotocustomerisavailable.有对已发运的缺陷批次物料召回的程序,可提供发给客户的通知。AQLusedatFinalInspectionpriortoI-5 customer150468911131415shipmentsareequaltoorbetterthanthefollowingrequirements:ElectricalParameters-0.10%MechanicalParameters-0.25%在向客户出货前最终检验的AQL等于或优于以下要求:电性能参数:0.10%机械性能参数:0.25%Thereisasystemfordocuments/recordsI-6 retention150468911131415andarekepttoaminimumnumberofyears.有文件/记录的保存系统,对文件/记录有最小保存年限。TOTALRATIN115TOOLINGPREVENTIVEMAINTENANCEThereissectionwithintheorganizatiJ-1onwhois150468911131415responsibleforthepreventivemaintenanceofalltoolingsintheplant.在组织中有专门负责模具预防性维护的部门。ThereisaprocedureinplacetoproperlyJ-2maintain20068101214161820alltoolingsandtheupdateofrelateddrawings.有适当维护所有模具并更新相关图纸的程序。SUPPLIERAUDITCHECKLISTRating:NS=NotSatisfactory,NI=NeedsImprovement,AD=Adequate,ER=ExceedsRequirementsTOOLINGPREVENTIVEMAINTENANCEThereisadesignatedareafortheproperJ-3storagearrangementoftoolings
Page7of____ComDegreplianeofceImpleRatinmentagFulltionWeightedScore None NI AD ER ScoreYes No NA (FS)10 0 3 4 5 6 7 8 9 10有指定的场所对模具进行恰当的保存和管理。ThereisasystemofidentificationorJ-4labeling100345678910toolings.有模具标识或标签系统。ThereisasystemofmonitoringtoollifeJ-5suchas20068101214161820numberofshotsofatoolandthefrequencyofrepairforpreventivemaintenancescheduling.有模具生命周期监控系统,如模具的工作次数和维修频次等来进行预防性的维护安排。TOTALRATIN75DRAWINGANDCHANGECONTRKOLAdequatecontrolsareineffecttoK-1assureapplicableengineeringdrawings,changenoticesandspecificationsareinusebyproductioandqualityatthetimeandplaceofoperation.有效运用适当的控制方式确保生产和品质部门的20068101214161820工作场所适时的使用有效的工程图纸、更改通知和规范。Thesystempreventstheuseofmarkedup,K-2obsolete,20068101214161820orillegiblespecificationsordrawings系统可防止经涂改的、作废的和难以辨认的规范和图纸的使用。Therevisionstodrawings,specificatiK-3ons,andprocedurearerecordedsoastomaintainhistoryfiles,andthedepartmentresponsibleforthisactivityisidentified.图纸、规范和程序的修改有记录,可保证文件的20068101214161820历史连续性,有明确的责任部门负责此工作。ThereisaprocedureforCustomerProductK-4orProcessChangeNotice(PCN)involvingmajororcritical300812161821262830changesrelatedtothefollowing:(a)SpecificationorDesignchanges,(b)Rawmaterialchange,(Changeinmanufacturingsite/Producttransfers,(d)ProductObsolescence,(5)Changeintestingand/orprocessassemblyortechnology.有向客户通报产品和过程更改的程序包括与下列相关的主要和关键变化:(a)规格和设计更改;原材料的变化;生产场地的变化或产品转移;产品停产;(e)测试或组装过程或技术的变化。TOTALRATIN90CONTINUOUSIMPROVEMENTMANAGEMENTAcontinuousimprovementplanisdevelopedL-1regularlytopromoteorganizationalcommitmenttocontinuouimprovequalityandproductivityandwiththeaimtofurtherimproveinternalandexternalcustomersatisfaction.有规律的推行持续改善计划促进组织持续的改善20068101214161820质量和生产能力,从而达到提高内外部客户满意度的目的。DocumentedinternalsystemauditsareL-2performe20068101214161820periodicallybyqualifiedauditorstoassesscompliancewiththequalitysystem,andresultsarereportedandreviewedbymanagement.定期由有资格的内审员实施文件化的内部系统审核,评估体系的符合性,结果向管理层汇报和回顾。SUPPLIERAUDITCHECKLISTRating:NS=NotSatisfactory,NI=NeedsImprovement,AD=Adequate,ER=ExceedsRequirements
Page8of____ComDegreplianeofceImpleRatinmentagFulltionWeightedCONTINUOUSIMPROVEMENLTScoreNoneNIADERScoreMANAGEMENTYesNoNA(FS)ThereisasysteminplacetoresolveL-3customercomplaintsorameasurementofcustomersatisfactionandhassetgoalsforcontinuousimprovement有客户投诉处理系统或其他方法评估客户满意度,对此有持续改善的目标。ThereisacompanywidepeopleinvolvemeL-4ntsuchassmallgroupactivities,cross-functionalteams,suggestionsystems,thatgeartowardscontinuousqualityimprovements.有公司所有员工可参与的活动推进持续的质量改善:如小组活动、跨部门小组、建议系统等。
25 0 8 10 12 14 18 22 23 2510 0 3 4 5 6 7 8 9 10TOTALRATIN75TRAININGANDEDUCAM TIONtrainingprogramisinplacetotrainnewhiresM-1orcontractualswhichidentifiestheresourcesrequiredaswellasthescreeningandqualificationprocessinvolved.有培训程序对新员工实施培训确保其资格满足20068101214161820要求,其中包括了筛选和评价过程。Regularproductionpersonnelaregivenre-M-2training20068101214161820orre-orientationsonaregularbasis.正式的生产员工可受到有规律的再培训。ThereisacompanywidetrainingprogramM-3to150468911131415upgradetheskillsofemployees.有全公司范围的培训计划提高雇员的技能。ThereexistaprogramforoperatorcertificatiM4onand20068101214161820disqualification(re-training).有评价操作人员资格和不合格再培训的程序。TOTALRATIN75GENERALHOUSEKEEPING,HANDLING,STORAGE,ANDPACKAGINGThesurroundingareaaroundtheplant,N-1offices,productioarea,storage/warehouse,andotherareaswithintheplantarecleanandorderly.工厂附近区域、办公室、生产区域、库房和厂内其他区域的环境整齐干净。Allmachines/equipmenandimmediatN-2eworkareregularlycleaned.所有的机器/设备和直接生产场所定期清扫。ProperequipmentormethodisbeingN-3usedinhandlingandtransitofrawmaterial,work-in-
20 0 6 8 10 12 14 16 18 2010 0 3 4 5 6 7 8 9 10processorfinishedgoods.使用适当的设备或方法操作和运输物料、半成品150468911131415和成品。ThereisaprocedureinplaceinthereceiptN-4andissuanceofstoredmaterialsthatensureFirst-In-First-Out(FIFO)compliance在库房物料的接收和发放方面,有明确的程序确20068101214161820保先进先出。PackagingmethodsbeingusedensuresN-5preventio150468911131415fromdamage,deterioration,andagainstcorrosion.使用的包装方法能防止损坏、变质和腐蚀。ThereexistpackaginginstructionsforeachN-6productthatvaryindimensions,contentpercontainer,andpackagingrequirements.包装操作指导对每一产品不同尺寸、不同容量和150468911131415不同要求均有说明。SUPPLIERAUDITCHECKLISTRating:NS=NotSatisfactory,NI=NeedsImprovement,AD=Adequate,ER=ExceedsRequirementsGENERALHOUSEKEEPING,HANDLING,STORAGE,ANDPACKAGINGPackagingtestsareconductedtoverifyeffectivenN-7ess
Page9of____ComDegreplianeofceImpleRatinmentagFulltionWeightedScore None NI AD ER ScoreYes No NA (FS)15 0 4 6 8 9 10 13 14 15ofpackagingmethodused.进行包装实验确认使用包装方法的有效性。ThereisanadequatesystemtoensureproperN-8storageandhandlingofsensitivematerialstotemperatureand/orhumidity.有适当的系统确保潮湿或温度敏感器件的合理使300812161820262830用和存储。ThereisawrittenprocedurethatclearlyN-9defines20068101214161820shelf-lifecontrolandsystemtoensurecompliance.有书面程序明确规定存储期限控制和确保执行的系统。ESDcontrolswhenapplicableareN- requiredinallareasofoperationandinvolvestheuseofwriststraps,groundedworktables,anti-staticpackagingmaterials,ESDwarningsigns.在所有应用静电敏感器件的操作区域均有静电控制要求,包括使用防静电腕带、接地工作台、防静电包装物料、防静电警示标志等。InanESDcontrolledenvironment,aN- procedureisinplacethatcoversESDAuditthatverifies,measures,andchecksESDgeneratingmaterialsresistivity/continuityofwriststraps,groundingofworktablesandequipments,andworkingconditionofESDcontroldevices.在静电控制区域,有静电稽查程序包括静电确认、测量、检查可产生静电物料的阻抗系数、防静电腕带、工作台和设备的接地,和对静电敏感器件的使用条件等。
15 0 4 6 8 9 11 13 14 1515 0 4 6 8 9 11 13 14 15TOTALRATIN190TOTALPRODUCTIVEMAINTENANCOEThereexistaformalprocedurefortheO-1preventive300812161820262830maintenanceofeachmajorproductionequipmenandcriticalparts.有正式的程序对每一重要设备和关键部件进行预防性维护AMasterPreventiveMaintenanceO-2Schedule150468911131415availableandstrictlyimplementedtoallproductionequipmentand有总的预防性维护计划并按严格计划对所有生产设备和部件实施维护AMaintenanceChecklistisavailableforeachO-3major150468911131415productionequipmentandupdatedregularly.每一主要设备均有维护查检表并例行更新ThereisasysteminplacetoensurethatO-4preventive20068101214161820maintenanceactivitiesarebeingdoneasrequired.有系统确保预防性维护工作能按要求落实TOTALRATI
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