ts內(nèi)審總結(jié)報告范本
201*年XXXXXXXXX有限公司內(nèi)審總結(jié)報告
一、審核目的:
確保公司質(zhì)量管理體系建立符合TS16949:201*標(biāo)準(zhǔn)的要求,及時發(fā)現(xiàn)體系運(yùn)行中的問題,并持續(xù)改善。二、審核范圍:
1、體系審核:TS涉及到的公司所有的職責(zé)部門,TS涉及到380V5HP馬達(dá)生產(chǎn)線。
2、過程審核:①XXXX馬達(dá)生產(chǎn)線②XXXX馬達(dá)生產(chǎn)線3、產(chǎn)品審核:①XXXX
②XXXX
三、審核日期:
1、體系審核:201*/6/5~201*/6/6
2、過程審核:①XXXX馬達(dá)生產(chǎn)線:201*/6/2②XXXX馬達(dá)生產(chǎn)線:201*/6/33、產(chǎn)品審核:①XXXX:201*/4/7②XXXX:201*/5/7四、審核員:
1、體系審核:XXXXXXXXXXXXX,由XXXX擔(dān)任此次審核的審核組長。2、過程審核:XXXXXXXXXXXXX3、產(chǎn)品審核:XXX五、審核依據(jù):
1、TS16949:201*版標(biāo)準(zhǔn)2、公司程序文件;3、作業(yè)指導(dǎo)書;4、相關(guān)法律法規(guī);
5、重要的客戶合同和要求;6、VDA6.3過程審核檢查表;
6、XXXXXXXX產(chǎn)品圖紙、包裝方法圖等。
六、內(nèi)部審核綜述
本次審核是公司的質(zhì)量管理體系建立以來的第二次正式、全面的的內(nèi)部審核。審核組由8人組成,對全公司的管理層、TS推進(jìn)室、總務(wù)人事、營業(yè)部、品證課、購買課生產(chǎn)、生產(chǎn)技術(shù)、物流課、設(shè)計開發(fā)等部門進(jìn)行了為期二天的審核。
本次內(nèi)部審核得到了總經(jīng)理及各部門主管的重視和支持,使審核工作進(jìn)展順利,按計劃完成了全部審核任務(wù)。體系審核過程中共發(fā)現(xiàn)不符合項(xiàng)13項(xiàng)(具體見不符合項(xiàng)分布情況表);過程審核平均總符合率為:97.25%;產(chǎn)品審核得分:100分。
另外需指出的是,由于本次審核使用的是抽樣的方法,而且內(nèi)審員的審核經(jīng)驗(yàn)和技巧都會有所欠缺,在內(nèi)審過程中沒發(fā)現(xiàn)不符合項(xiàng)的部門并不代表該部門不存在不符合項(xiàng),發(fā)現(xiàn)不符合項(xiàng)的部門也并不是說明該部門做得很差。但不論是發(fā)現(xiàn)有不符合的部門還是未發(fā)現(xiàn)不符合的部門,都應(yīng)該認(rèn)真總結(jié)在內(nèi)審過程中存在的一些不足之處,并對自己部門進(jìn)行定期的檢查,以維持過程的持續(xù)有效性,并不斷改進(jìn)。
綜上所述,本公司的質(zhì)量管理體系已經(jīng)進(jìn)入正常有效的運(yùn)行狀態(tài),由于本公司建立管理體系的時間不是很長,各部門依然會存在有不少問題。這需要通過全體員工的共同努力,持續(xù)改善公司的產(chǎn)品質(zhì)量,使公司的整體管理水平更上一個臺階。
內(nèi)審總結(jié)報告擬訂人:XXXX日期:201*年6月7日
擴(kuò)展閱讀:審核報告(TS)V
審核報告
高頂科技(無錫)有限公司
報告編輯人鄒超剛審核開始日期19/05/201*
審核報告
綜述
報告編輯人鄒超剛相關(guān)的審核活動如下:
SMO/審核類別/審核日期/審核時間7208712再認(rèn)證審核(重審方式)19/05/201*4人天員工人數(shù)82
ToverifythatyourqualitymanagementsystemcontinuestomeettherequirementsofISO/TS16949:201*andanyapplicableadditionalcustomerspecificrequirements,andisbeingeffectivelymaintained.
此次審核目的是“驗(yàn)證公司質(zhì)量管理體系持續(xù)符合TS16949:201*的要求及客戶的特定要求,并有效執(zhí)行”
證書號/認(rèn)證標(biāo)準(zhǔn)TS508229ISO/TS16949:201*地點(diǎn)地址高頂科技(無錫)有限公司中國無錫市國家高新技術(shù)產(chǎn)業(yè)開發(fā)區(qū)珠江路40號214028管理總結(jié)
2NCsbefoundinthisvisitandthisRe-assessmenthasresultedinanOPENverdict.2個一般不符合項(xiàng)被發(fā)現(xiàn),本次審核的結(jié)論待確定(OPEN)。
Rootcauseanalysisisrequiredforeachnonconformityidentifiedwithinthisreport,andcorrespondingcorrectiveactionsdefined.The
organizationshallapplytoothersimilarprocessesandproductsthecorrectiveaction,andcontrolsimplemented,toeliminatethecauseofanonconformitytopreventthesamenonconformityoccurringelsewherewithintheorganization.
針對本次審核發(fā)現(xiàn)的不符合需進(jìn)行根本原因分析并制定對應(yīng)的糾正措施。組織應(yīng)將已采取的糾正措施和實(shí)施的控制應(yīng)用于其他類似的過程和產(chǎn)品中存在的不符合原因,以防止類似不符合項(xiàng)的再次發(fā)生。
Pleasesubmitacorrectiveactionplan,whichidentifiesactionsproposedtoresolveeachnonconformityandtimescalesfortheseactionstobecompleted,toKaneZouforreviewbefore12thJun.201*.
在201*年6月12日前,貴公司需針對已發(fā)現(xiàn)的不符合項(xiàng)提交糾正措施計劃,明確整改完成時間。
Pleasealsosubmitacorrectiveactionpackbefore7thAug.201*,whichidentifiestherootcauseanalysisandactionstakento100%resolveeachnonconformity,alongwithfullsupportingevidencetodemonstrateeffectivenessofactionstakeninresolvingthenonconformityandpreventingrecurrencetoBSIClientManagerforreviewandacceptancewithinthe90daysfromthedateoftheclosingmeetingofthisre-assessment,asprescribedinISO/TS16949:201*Schemerules.
請于201*年8月7日前提交糾正措施整改的全部資料,包括根本原因分析、100%解決的措施及措施已有效實(shí)施證據(jù)等等。
PlanandcorrectiveactionpackshouldbesentposttoBSIBeijingofficeMr.KaneZou
faxto86-021-54660556orbye-mailtoKane.zou@bsi-global.comandreferencetheaboveJobnumber/s.上述整改措施計劃及整改資料包請交到BSI上海代辦處鄒超剛傳真:86-021-54660556郵箱:Kane.zou@bsi-global.com
Theassessmentteambelievesacorrectiveactionsubmissioncouldgivesufficientdetailtoverifyclosureofanyminornonconformitiesraised,sotheeffectivennessofcorrectiveactionswillbeverifiedremotelyandfinalverificationwillbeconductedduringnextsurveillanceaudit.針對本次審核發(fā)現(xiàn)的一般不符合項(xiàng)所提交的整改資料請務(wù)必詳實(shí),在此基礎(chǔ)上,BSI審核組將對糾正措施的有效性進(jìn)行文件驗(yàn)證,進(jìn)一
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步的驗(yàn)證將在下次監(jiān)督審核時進(jìn)行。
ThiscanbeconvertedtoaRECOMMENDEDverdictby100%resolutionofallnonconformitiesdetailedinthisreport,andverificationofeffectivenessofactionsbyBSI,withina90-dayperiodfromoftheclosingmeetingofthisre-evaluation,asprescribedinISO/TS16949SchemeRules.
根據(jù)ISO/TS16949認(rèn)可規(guī)則要求,在本次審核結(jié)束后90天內(nèi),如果審核發(fā)現(xiàn)的不符合項(xiàng)已得到100%解決并經(jīng)BSI確認(rèn),本次審核的結(jié)論將轉(zhuǎn)化為推薦(RECOMMENDED)。
However,ifallnonconformitiesarenotverifiedas100%resolvedwithinthe90-dayperiod,theOPENverdictwillbedowngradedtoNOTRECOMMENDED,andacompletecertificationaudit,Stage1and2willberequired.否則,本次審核的結(jié)論將轉(zhuǎn)化為不推薦注冊(NOTRECOMMENDED)。
TherecommendationmadebytheAuditTeamissubjecttoindependentreviewatBSIbyanIATFapprovedreviewer.Followingapprovalbytherevieweryourcertificatecanbeissued.
本次審核的資料需要得到IATF認(rèn)可的BSI評審員的評審確認(rèn)。
Onsuccessfulcompletionofthisreview,yourISO/TS16949:201*certificatewillbeissued.上述事項(xiàng)全部完成后,貴公司的認(rèn)證證書才能發(fā)放。
Webelieveinapartnershipapproachthatprovidesandaddedvalueservice.基于戰(zhàn)略伙伴的合作,我們將為貴公司提供更加增值的服務(wù)。
The0.5MDforfollowingupNCsraisedandthenextauditdurationwillbe3.5MDs.
后續(xù)的監(jiān)督審核將每12個月進(jìn)行一次,每次3人天。下次審核將增加0.5人天用于不符合項(xiàng)的跟蹤,下次審核時間將為3.5人天。
Withinthreeyearsofthisauditare-certificationauditwillberequiredtofacilitateongoingcertification.ThedurationoftherecertificationwillbeasspecifiedinAnnex3oftheschemerules.證書有效期為3年,到期后將安排重新認(rèn)證審核。針對上次審核提出的輕微不符合所采取的糾正措施已被評審并確認(rèn)實(shí)施有效。2個需要跟進(jìn)的不符合及其它發(fā)現(xiàn)點(diǎn)將在后面的報告中提出。
輕微不符合為偶然的缺失,并不意味著管理體系的相關(guān)流程失控。應(yīng)調(diào)查導(dǎo)致不符合的根本原因以確定相應(yīng)的糾正措施。糾正措施是否被有效實(shí)施將在下次審核中確認(rèn)。
請向BSI提交糾正措施計劃包括不符合內(nèi)容,原因分析,相應(yīng)的糾正措施及其責(zé)任人和實(shí)施計劃。請于12/06/201*前通過電子郵件或者傳真的方式將糾正預(yù)防措施計劃提交至以下聯(lián)系方式,并請在計劃上注明相關(guān)報告號碼。
被審核區(qū)域和審核發(fā)現(xiàn)
Processauditcommentary
TopManagement-Overviewofsystemstructure(COP/SP/MP)/Keyperformanceindicators/Customerspecificrequirements/M1-StratagemPlanning/M2-Managementreview/M3-internalAudit/M4-continualimprovement/ReviewofperformanceoftheQMSoverthecertificationlifecycle/Allpreviousauditreports/closeoflastNCRsfromCAV2audit(NCR-KZ-1,NCR-AQ-1~3(4.1/4.2.1/4.2.2,5.1-5.6,6.1)
ThemainresponsiblepersonnelMr.ZhangandM.R.Mr.SunshowstheirrelevantplanningandimplementingprocessofTS-QMS,andwiththebigeffortsinordertogetitseffectiveperformance.
LastcompletecycleofmanagementreviewwascarriedoutaccordingtoISO/TS16949-201*on8thDec.201*,evidenceverifiedforlastoneyearshowsgoodperformance/compliance.
Customersatisfactionindicatorsandcorrespondingcorrectiveactionsshowtohavesignificantpositivetrend.ManagementreviewInputs,outputandconclusionsareproperlyaddressed,documentedinverydetailedcorrectiveaction/andcontinuousimprovementPlans.
Theinternalauditsystemiswelldeterminedanddocumentedinit’scorrespondingprocedure;EvidenceverifiedoflastInternalqualityaudit
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cycleon20thMar.to28thApr.09showedthatthesehavebeenexecutedinaneffectivemanner,coveringalltheprocesses,threeexistingmanufacturingshifts,andalltheexistingcustomersrequirement,themanufacturingprocessandproductauditwasconductedaspertheannualplan.AdequatecorrectiveactionsareinplaceforeliminationofN.C.ItwasverifiedaproperInternalauditorsqualificationandindependencyalso.Adequatesystemisinplaceforcontinuousimprovementactivities;Form201*yearuntiltoday,someproject
Improvementcaseswereimplemented.Acceptablelevelwasobservedregardingtheactivitiesforcontinuousimprovementonprocesseswhichhavedemonstratedtobecapableandstable.Thepoorqualitycostwasaccountedandanalysedbyfinancedept.regularly.
Businessplanwasdevelopedbaseonthecustomerrequirementsandexpectations,KPIsandrelevantdatawascollectedandreviewedregularlybytopmanagement,andledtoimprovement.sampledevidenceshowedtheeffectiveness.
Duringthisvisit,Performanceofsystemovercertificationcycleincludingthereviewofthepreviousauditreportswasreview.relevantperformanceandtendofqualityobjectivesandtargetswasreviewed.
C1-Marketing&Sales/C4-delivering/C5-service
TheKPIrelatedsalesprocesswasmonitoredandgenerallyacceptable.Thecustomers"contractwasreviewedbymulti-departments.Customerrequirementswereaddressed.Thecustomerfeedbackisgood.Thedeliveryprocessoperatingeffectively.customerfeedbackinformationwastimelynotifiedtorelevantfunctionandreplybacktocustomer.Customersatisfactionwasconductedonceperyearandanalyzedforcontinualimprovementsandtheresultsofsatisfactionwereacceptable.
C2-Processdesign(7.1,7.2,7.3)
Organizationhaveadocumentedprocedureforprocessdesign,andformthecustomerrequirementidentification,tospecialcharacterisitcs,PFMEA,controlplanandSOP/SIPdocumentsreviewanddevelopment.includedrelevantexperimentsfordesignverification,equipmentandtoolingverification,andpreliminerycapabilitystudy.
butoneNCraisedinthisareaagainstsepcialcharacteristicidentificationandreview.detailpls.seeNC-KZ1Therecordofengineeringchangesin201*yearwasreviewed,releantchangesrecordmaintainedwell.
S4-Purchasing/Suppliermanagement/S5-ProductPreservation/Customerproperty(7.4/8.2.4/5.4.1)
Themethodandcriteriaforselection,evaluationofsupplierhavebeenestablished.Re-evaluationwasconductedonceperyearasper
requirement.Thepurchasingperformancewasgenerallygood.PurchaseorderandshippinginformationinERPsystemareworkedoutbypurchserduetosafestock,customer"sforecast,productionplananditisapprovedbyplantmanager.theinspectioncriteriaofforIQCwereestablishedaspercustomerrequirement,Therelevantinspectionrecordsmaintainedwell.
C3-Manufacture/processcontrolincludingID&traceability/sitemgt.&safetymgt.TwoShift:08:00-17:00&20:00-03:00
TherelevantKPIsetforproductionprocessestablishedandverifiedasgenerallyacceptable.Themanufactureprocessesinclude2shifts.Mostoftheoperationsandcontrolparameteradjustmentwereimplementedbytheelectroplatingline.Requirementsaredeployedinthemanufactureprocesstomeettheproducts’specification.Controlplanandrelativeworkinstructionsareavailableinworkstation.Theoperationsareimplementedastheplannedrequirements.Thewrong-proofmethodwasusedinrelatedprocessforprocesssteps.The
identificationfortheproductsandnonconformingproductsismadeclearly,therelevantprocessmonitoringrecordsmaintainedwell.butoneNCraisedagainsttheprocessmonitoring.detailpls.seeNC-KZ2.
S3-equipment/toolingmaintenance
Documentedprocedureswereimplemented.Keyprocessequipmentswereidentifiedandrelevantmaintenanceactivitieswereconducted.Thereareplanstoperformtheseactivitiesandtheyaremetasplanned.Asystemforproductiontoolingmanagementwasconducted,thetoolingweremanagedandmaintainedgood.ISO14001EMShadbeencertificatedandoperatingwell.
S6-ProductInspectionincludingprocessmonitor,NCproductcontrol/S7-MonitoringandMeasurementDevicesManagement/lab.Management/M5-CAPA(7.4.3/8.2.3/8.2.4/8.5.2/8.5.3/7.6)
Finalinspectionandin-processcontrolwereimplementedduringthemanufacturingprocess.TherelevantinspectionrecordssampledandverifiedasOK.
ProductfunctionaltestwerecarriedoutaccordingtocontrolplanandinspectioninstructionbyLab.,relevantLab.manualandtestcriteria
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wasestablished,andrelevantinspectionrecordmaintainedwell;thelaboratoryengineerswerequalified.Thescopeofthelaboratorywasdefinedtoo.
NCproductsincludingtheprocess,final,andreturnproductwereanalysed;Defectproductwasclearlyandstrictlyidentifiedateachprocess,reworkedorrepairedpartswerere-inspected.relevantcorrectiveandpreventiveactionswerehandledaccordingtodefinedprocedures.Measurementdeviceswerecalibratedandcontrolledregularlybyinternalcalibrationlab.andexternallicensedbody.TheMSAwasperformedaccordingtotheannualplanning
S1-Documentandrecordcontrol(4.2.3,4.2.4):
Masterlistfordocumentsincludingexternaldocumentsandrecordsareestablished.Alldocumentshavebeenreviewedandapprovedbeforeissuedtotherelateddepartments.Theobsoletedocumentsarecontrolledby"Justforreferencestamp"onthedocuments.
S2-HR/motivation(6.1,6.2)
Thecompetenceofemployeeisdefinedinthe"PositionDescriptionSheet"foreachJobtype.Relatedemployeearereviewedtomeettherequirements.Annualtrainingplanhadbeendevelopedandrelatedtrainingrecordshadbeenkept.Onthejobtraininghavebeengiventoproductionpersonnel.theemployeesatisfationsurveywasconductedinNov.201*,relevantimprovementplanofsatisfactionwasimplemented.OFI
1.Presentlytheequipmentmanagementprocesskepteffectiveness,theKPIresultsofequipmentkeptsatisfied.buttheidentificationofkeyequipmentshouldbemoreclear.Itwouldbebeneficialtousethepredictivemaintenancemethodtosomekeyequipment.當(dāng)前設(shè)備維護(hù)過程保持有效,關(guān)鍵過程績效保持良好,但關(guān)鍵設(shè)備的識別應(yīng)加強(qiáng),針對關(guān)鍵設(shè)備實(shí)施預(yù)見性維護(hù)將是有益的.
上次審核提出的不符合
序號A176956/1內(nèi)容區(qū)域/流程Manufacture/NCR-KZ-1條款7.1.4DescriptionofNonconformity:Thechangecontrolprocesswasnotimplementedeffectively。更改控制過程不能保證有效實(shí)施。Requirement:7.1.4Changecontrol更改控制Theorganizationshallhaveaprocesstocontrolandreacttochangesthatimpactproductrealization.Theeffectsofanychangeshallbeassessed,andverificationandvalidationactivitiesshallbedefined.組織應(yīng)有對影響產(chǎn)品實(shí)現(xiàn)的更改進(jìn)行控制并作出反應(yīng)的過程。任何更改的影響都必須被評定,驗(yàn)證和確認(rèn)的活動必須被定義。Evidenceobserved:checkplating-Sntanksite,thetemporaryprocessstandardSpecforSn-ionwaschangedfrom60to64,buttheverificationandvalidationactivitieswasnotdefined.查核『鍍純錫槽』作業(yè)點(diǎn),臨時工藝標(biāo)準(zhǔn)值:錫離子由60改為64,但相關(guān)的驗(yàn)證和確認(rèn)的活動未被定義。ActionrelatedtothisNCRwasaddressedeffectively.itwas100%closed.是行動是否關(guān)閉?序號A176956/2內(nèi)容區(qū)域/流程measurmen&monitoring/NCR-AQ-1條款8.1.1/8.1.2DescriptionofNonconformity:-Theorganization’sprocessforundertakingthemeasuringandmonitoringwasnoteffectiveinensuringappropriatestatistictoolsbeusedtomeetcustomerrequirement.報告編輯人鄒超剛
審核開始日期19/05/201*
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檢驗(yàn)和監(jiān)控活動未能有效確保使用合適的統(tǒng)計工具以符合客戶要求.Requirement:-1.appropritatestatistictoolsforeachprocessesshallbedeterminedandincludedinthecontrolplan.應(yīng)當(dāng)確定每個工序所適用的統(tǒng)計工具并規(guī)定在控制計劃里.2.Basicstatisticalconcepts,suchasvariation,control…shallbeunderstoodandutilizedthroughouttheorganization.基本的統(tǒng)計概念,包括變差,受控..等應(yīng)當(dāng)在組織內(nèi)被理解和運(yùn)用.Evidenceobserved:-1.CutomerrequiredthicknessCPK>1.5,notbeenincludedincontrolplan.客戶要求厚度CPK>1.5,但SPC要求沒有列在控制計劃中.2.therelatedpersonneldidn’tunderstandprocesscapabilityandcan’tconductprocessstudycorrectly.相關(guān)人員不理解過程能力的概念且未能正確進(jìn)行過程研究行動是否關(guān)閉?序號A176956/3內(nèi)容區(qū)域/流程Measurementdevicesmgt./NCR-AQ-2條款7.6ActionrelatedtothisNCRwasaddressedeffectively.itwas100%closed.是Descriptionofnonconformity:Theorganization’smeasurementdevicemgt.processwasnoteffectivelyconductedtoensuremetrequirementofcalibrationandMSA.測量設(shè)備管理過程沒有有效確保符合校準(zhǔn)和MSA的要求.Requirement:1.statisticalstudiesshallbeconductedtoanalysethevariationpresentintheresultsofeachtypeofmeasurementsystemincontrolplan.控制計劃中的所有測量系統(tǒng)都應(yīng)當(dāng)進(jìn)行統(tǒng)計研究來分析其變差.2.…internallabfacilityshallhaveadefinedscopethatincludesitscapability….內(nèi)部實(shí)驗(yàn)室應(yīng)當(dāng)有規(guī)定的范圍以確認(rèn)其能力.3.…externallabfacilitiesusedforinspection,testorcalibrationservicesshallhaveadefinedlabscope….andshallbeevidencethattheexternallabisacceptabletocustomerorbeaccreditedtoISO/IEC17025ornationalequivalent..提供檢驗(yàn),試驗(yàn),校準(zhǔn)活動的外部實(shí)驗(yàn)室必須有確定的實(shí)驗(yàn)室范圍包括實(shí)施要求的檢驗(yàn),試驗(yàn),校準(zhǔn)活動的能力,而且必須有證據(jù)證實(shí)該實(shí)驗(yàn)室被客戶接受或是通過了ISO/IEC17025或等同標(biāo)準(zhǔn)的認(rèn)可.Evidenceobserved:1.sometypemeasurementsystemincontrolplanhadnotbeanalyzedcorrectly,suchas:visualinspection.一些控制計劃提到的測量系統(tǒng)未進(jìn)行分析,如:目視檢查.2.nointernallabscopedefined.無內(nèi)部實(shí)驗(yàn)室范圍.3.noevidencethatsomecalibrationbeconductedbyexternallabwithcapability.Suchas:scale.部分校驗(yàn)活動的外部實(shí)驗(yàn)室無具備能力的證據(jù).ActionrelatedtothisNCRwasaddressedeffectively.itwas100%closed.是行動是否關(guān)閉?序號A176956/4內(nèi)容區(qū)域/流程Documentcontrol條款4.2.3.1DescriptionofNonconformity:Theorganization’sprocesstoreviewandimplementationallcustomerspecificationsandchangeswasnoteffectivelytoensureupdatedralateddocuments.組織評審和實(shí)施客戶技術(shù)規(guī)范和變化的過程未能有效確保更新了所有相關(guān)文件.Requirement:asper4.2.3.1.見標(biāo)準(zhǔn)4.2.3.1要求報告編輯人鄒超剛
審核開始日期19/05/201*
第6頁,共12頁審核報告
Evidenceobserved:Customerspecification508-9314,Rev:E,thicknessrequirementtoSOTtype:7~15um,buttheinspectionstandardhadn’tbeenupdated.WI080520,Rev:H,4~12um.客戶技術(shù)規(guī)范508-9314,(E)的厚度要求:SOT,7~15um,但產(chǎn)品檢驗(yàn)規(guī)范WI080520,(H)為4~12um,沒有更新.行動是否關(guān)閉?ActionrelatedtothisNCRwasaddressedeffectively.itwas100%closed.是此次審核提出的輕微不符合
序號A297346/1內(nèi)容區(qū)域/流程ProcessDevelopment條款7.3.2Nonconformitydescription:(不符合描述)Thenewproductprocessdevelopmentwasnoteffectivetoensureallspecialcharacteristicsbeingidentifiedandreviewedasthedesigninput.新產(chǎn)品的過程開發(fā)不能有效確保作為開發(fā)輸入的特殊特性得到充分的識別和評審Requirements:(要求與依據(jù))7.3.2DesignanddevelopmentinputsInputsrelatingtoproductrequirementsshallbedeterminedandrecordsmaintained7.3.2.3SpecialcharacteristicsTheorganizationshallidentifyspecialcharacteristics.[see7.3.3d]NOTE:Specialcharacteristicscanincludeproductcharacteristicsandprocessparameters.7.3.2設(shè)計和開發(fā)輸入必須確定與產(chǎn)品要求有關(guān)的輸入,并保持記錄(見4.2.4)。7.3.2.3特殊特性組織必須識別特殊特性(7.3.3d))注:特殊特性可能包括產(chǎn)品特性和過程參數(shù)。ObservedEvidence:(證據(jù))Intheprocessdevelopmentofnewproductspec#SOT2316UP,itwasfoundthespecialcharacteristicswasnotidentifiedandreviewedadquencyaspertherequirementofthecustomerproductspecification,i.e.Thickness/AnnealingBake/Solderability在件號為SOT23UP16過程開發(fā)中發(fā)現(xiàn),特殊特性未能充分地識別.如:鍍層厚度/可焊性,及相關(guān)的工藝參數(shù)等序號A297346/2內(nèi)容區(qū)域/流程ProcessMonitoring條款8.2.3DescriptionofNonconformity:Theorganization’sprocessforassuringthemanufactureprocessmonitoringwasnoteffectiveinensuringprocessparameterwasconformitywiththeworkspecification.組織的制造過程監(jiān)控?zé)o效,無法確保制造過程參數(shù)符合作業(yè)規(guī)范的要求.Requirement:8.2.3MonitoringandmeasurementofprocessesTheorganizationshallapplysuitablemethodsformonitoringand,whereapplicable,measurementofthequalitymanagementsystemprocesses.Thesemethodsshalldemonstratetheabilityoftheprocessestoachieveplannedresults.Whenplannedresultsarenotachieved,correctionandcorrectiveactionshallbetaken,asappropriate,toensureconformityoftheproduct.Evidenceobserved:報告編輯人鄒超剛
審核開始日期19/05/201*
第7頁,共12頁審核報告
Inprocessofrackplatingline,thetemperatureofhotDIwatershouldbe50°C-70°casperrequirementofworkinstructions,butonsitefoundtheactualtemperatureis40°C.在掛鍍線上發(fā)現(xiàn)熱純水洗的溫度只有40度,而作業(yè)指導(dǎo)書上規(guī)定的是50-70度TS16949的附加范圍要求
每個地點(diǎn)已被審核的客戶特別要求:Nodocumentedcustomerspecificrequirement
由OEM客戶指定給每個地點(diǎn)供應(yīng)商的代碼(適用時):Infineon:70291Amertron:181每個地點(diǎn)允許的刪減:productdesignanddevelopment在認(rèn)證范圍內(nèi)是否有任何支持場所:否
TS16949輪班情況
地點(diǎn)輪班1輪班2輪班3輪班4夜班周末所有場所員工數(shù)82WuxiMfgplantExists?Audited?審核參加人員
被認(rèn)證組織代表:姓名Mr.WenruiZhangMr.BoBoSunMs.LijuanLiu
BSI參加審核人員:姓名鄒超剛職位審核組長職位GeneralManagerGMAssistant,MRQC/QAsupervisor報告編輯人鄒超剛
審核開始日期19/05/201*
第8頁,共12頁審核報告
監(jiān)督審核
具體的監(jiān)督審核方案如下.
地點(diǎn)地址高頂科技(無錫)有限公司中國無錫市國家高新技術(shù)產(chǎn)業(yè)開發(fā)區(qū)珠江路40號214028
在每個審核周期結(jié)束時,或在需要時提前,將對全部體系進(jìn)行復(fù)評。
證書號/審核周期TS508229審核間隔審核時間下次重審12月21小時01/05/201*重審計劃
業(yè)務(wù)區(qū)域/地點(diǎn)日期(mm/yy)時間(人天)C1-Marketing&Sales/C4-delivering/C5-serviceincludingcustomersatisfactionandComplaintsC2-processdesignC3-Manufacture/processcontrol/ID&traceability/on-sitemgt.&safetymgt.S4-Purchasing/SuppliermanagementS5-ProductPreservation/CustomerpropertyS6-ProductInspectionincludingprocessmonitor,NCproductcontrolS3-equipment/toolingmaintenanceS1-Doc./recordcontrolS2-HR/motivationM5-CAPAactionS7-MonitoringandMeasurementDevicesManagement/lab.ManagementM5-CAPAactionM3-InternalAudits/M2-ManagementReviewM4-ContinualImprovementM1-StratagemPlanning審核105/103.5審核205/113.0審核305/124審核4審核5審核6報告編輯人鄒超剛
審核開始日期19/05/201*
第9頁,共12頁審核報告
-Organization/CustomerChanges-ManagementSystem&Changes-Effectivenessoflastvisitcorrectiveactions-customerspecificrequirement-Re-certificationaudit-threeyearcycle下次審核計劃
審核目的
AssessmentoftheeffectiveimplementationoftheQualityManagementSystemoforganization.
inmeetingtherequirementsofISO/TS16949:201*&ISO9001:201*,plusassociatedsupportdocumentationandadditionalcustomerrequirements,companyobjectives,policiesandprocedures.審核范圍
ThemanagementsystemimplementedtosatisfytherequirementsofISO/TS16949:201*,plusassociatedsupportdocumentationandadditionalcustomerrequirements(asappropriate).
Detailsrefertobelowplannedarea/processes/activities:3MDs+0.5MDforcloseNCR日期01/05/201*審核員時間09:0009:3009:40區(qū)域/流程OpeningMeeting首次會議FactoryTour工廠參觀TopManagement-Overviewofsystemstructure(COP/SP/MP)/Keyperformanceindicators/Customerspecificrequirements/M1-StratagemPlanningTeammeetingCascadeprocessdeploymentM2-Managementreview/M3-internalAudit/M4-continualimprovementC1-Marketing&Sales/C4-delivering/C5-serviceC2-Processdesign/ClosedandverifiedNC-KZ1C3-Manufacture/processcontrolincludingID&traceability/sitemgt.&safetymgt.TwoShift:08:00-17:00-08:00C3-Manufacture/processcontrolincludingID&traceability/sitemgt.&safetymgt./NC-KZ2TwoShift:08:00-17:00-08:00S3-equipment/toolingmaintenanceS6-ProductInspectionincludingprocessmonitor,NCproductcontrolS7-MonitoringandMeasurementDevicesManagement/lab.條款4.1,4.2.1,4.2.2,5.402/05/201*10:3010:4009:004.1,4.2,5.1-5.6,8.2.2Logouse7.2/7.5.1/8.2.14.2.3.1/7.1/7.37.5/8.2.3/8.2.4/8.3/8.5.1.27.5/8.2.3/8.2.4/8.3/8.5.1.26.3,7.5.1.4,7.5.1.57.4.3/7.5.5/8.2.3/8.2.4/7.603/05/201*09:0003/05/201*09:00報告編輯人鄒超剛
審核開始日期19/05/201*
第10頁,共12頁審核報告
ManagementM5-CAPA
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11:3013:3014:0012:0017:30AssessorsreviewandreportpreparationClosingMeetingEndLunch&AssessorreviewDailyWashUpMeeting注
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附頁
1.ScopeofCertification
Theprovisionofsemiconductorandelectroniccomponentelectroplating.PermittedExclusions:ProductdesignandDevelopment
2.CustomerSatisfaction/ComplaintManagement
Theclientorganization"sprocessforreviewofcustomersatisfactionandcomplaintswasauditedasapartofthisauditandfoundtobeeffectiveinmeetingtherequirementsoftheTechnicalSpecification.untiltodaynoanycomplaintsandreturnedrelatedtoautomobileproductissuedbycustomer.
3.NotificationstoBSI
AspartofBSI"sTermsandConditionsandinaccordancewithISO/TS16949:201*SchemeRules,itisnecessaryforyoutonotifyBSIofanyofthefollowing:
報告編輯人鄒超剛
審核開始日期19/05/201*
第11頁,共12頁審核報告
◆MajorchangestoQSystem
◆Changeofownership,mergeroracquisition◆Significantchangetoemployeenumbers◆Introductionofnewproducts/processes◆Introductionofnewcustomers
◆Initiationofcustomerenforcedsanctions
NotificationshouldbemadetoyourClientManager,within5businessdaysofoccurrence.
YourClientManagerwillevaluatetheimpactofthenotification,reviewthiswiththeBSIschememanagerandcontactyouasnecessarytodiscussanyadditionalactivitiesrequiredasaresult.
4.CustomerSatisfactionSurvey
AtBSI,wearekeentogetfeedbackonourperformance.Pleasecompleteourcustomersatisfactionsurvey.Youwillbeaskedforyour"JustforCustomers"usernameandpasswordtocompletethissurvey.Ifyoudonotknowwhatyourusernameandpasswordis,pleasecallBSION-LINE:800-810-0045
CustomerServiceOfficer:Ms.Daisy.Qian,Daisy.qiang@bsi-global.com
報告編輯人鄒超剛
審核開始日期19/05/201*
第12頁,共12頁
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