55準(zhǔn)

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成ChangeHistory更錄___________________________________________RevisionEffectiveDateOriginatorReasonsforChange本效期2.02018.03.21

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___________________修原___________________新增定必將校標(biāo)簽在器的本上3.0-2020.11.05ACId454.3andUPdate6.11.0PUrPOSe目的1.1describestheactionstoensuremeasuringequipmentusedtodetermineproductqualityisoftherequiredaccuracy.Itdescribesidentificationmethod,checkingplan,statusandrecordingsystem.為確關(guān)系品品的監(jiān)測量備達(dá)足夠精度求本程介紹對這設(shè)備行標(biāo)，設(shè)定檢查計，以狀態(tài)及記的系。2.0SCOPe范圍2.1Thiscoversallmeasuringtools,equipment,goldensamplesandstandards,whichrequirescalibrationand/orverificationatMMK.本程包含本公所有需要驗或證的量工，備，準(zhǔn)樣以及準(zhǔn)片3.0DefinitiOnS義3.1MeasuringEquipments:measuringinstrument,software,measurementStandardreferencematerialorauxiliaryapparatusorcombinationthereofnecessarytorealizeameasurementprocess.Todetermineaphysicalquantity,magnitudeordimensionandthenjudgetheobjectmeettherequirements.測量備：實現(xiàn)量過所必的測儀器軟件測標(biāo)準(zhǔn)標(biāo)準(zhǔn)質(zhì)或助設(shè)或它的組合，一般于確物理、規(guī)大小者尺的大，根其果判被測對象否符規(guī)定要求。3.2MonitoringEquipment:observingandsupervisingdevices.Monitoringimpliesobserving,supervising,underreview(usingmonitoringdevices).監(jiān)視器：于生過程態(tài)確的儀設(shè)備監(jiān)視觀、監(jiān)、處評審（通使用視裝置）

3ProcedureandFlowchart程流圖4.1Responsibilityandauthority職責(zé)與限4.1.1LabTechnicianisresponsibleformanagetheequipments*calibrationsystem.由實驗技員負(fù)維護(hù)備校系統(tǒng)4.1.2Eachdepartmentisresponsibleforthecontrolofmonitoringandmeasuringdevicesusedintheirareas.各部負(fù)責(zé)本區(qū)內(nèi)使的監(jiān)和測設(shè)備行控；4.1.3engineer（forproduction）andlaboratoryTechnician（lab）shallcarryoutinternalcalibrationofmeasuringequipment.Andtheymustbetrainedabouttherelatedinternalcalibrationmethods.工藝程師生產(chǎn)用檢儀器以及驗室術(shù)員實室用測儀）執(zhí)內(nèi)部驗，們須經(jīng)相關(guān)儀器驗技培訓(xùn)4.1.4Methodchecki∩g∕calibrateisdescribedintherelevantSOP.檢查/校驗方法具體操作程。4.1.5測量儀由質(zhì)部統(tǒng)一請請，質(zhì)部門寫《購申單》詳注明格、號、求，批后采購門尋相應(yīng)應(yīng)廠進(jìn)行購。

殊要4.1.6QualitydepartmentvalidatethemeasuringequipmentsandregisterintoTS-405.01<Calibrationdevicescontrolandlist>afterpurchase,takecalibration.測量器采入庫質(zhì)量驗收《備驗單登記計量具管臺及校計4.1.7

實驗保存廠合證或證書使用明書4.2Traceabilityandqualificationcalibrationstandards檢驗標(biāo)的可溯以及威性4.2.1Externaltraceofstandards:Thestandardsofcalibrationmustbesentoutforcalibrationperiodically,andmusttraceableto∩ational∕i∩ternationalstandard.標(biāo)準(zhǔn)外部源：來內(nèi)校驗標(biāo)準(zhǔn)須定送到部權(quán)威構(gòu)進(jìn)校驗其校可溯源國家國際準(zhǔn)；4.2.2Specialtraceinstruction:Forspecialmeasuringequipmentthatexternalcalibrationlabalsocannotdoduetolackofequipmentorproperstandard,calibrationpeoplemaythespecialcalibrationinstructionorformulatocalibrateitdescribeitintodocument.特殊溯：一特殊的設(shè)，由缺乏當(dāng)?shù)臏?zhǔn)設(shè)或校標(biāo)準(zhǔn)外部構(gòu)無法行校驗的，驗人可以行設(shè)計定的驗指書或用規(guī)來實校驗并在件說明

，，4.2.3Theprecisionofstandardmustbe10timesormorethancalibratedequipment.Ifthestandardasampleforcomparison.用來驗的準(zhǔn)的度必為被驗設(shè)的倍以上如果準(zhǔn)樣是用進(jìn)比對，其少與驗設(shè)的精等級同。4.2.4Mustbetraceabletonational/internationalstandard.所有驗標(biāo)必須溯源國家國際標(biāo)準(zhǔn)4.2.5Shouldstoredunderstatedcondition.儀器備必在規(guī)的環(huán)條件存放4.3IdentificationandRegistrationofmeasuringequipment.監(jiān)視量設(shè)的標(biāo)和登4.3.1LabTechniciancombinealltheequipmentsthatmustbecalibrationandbuildupaCalibrationMasterListtomanage實驗技術(shù)對所需要驗的備進(jìn)整理并建設(shè)檢驗單來行管；Measuringequipmentthataredirectlyandindirectlyrelatedtoproductshouldbeincludein<Calibrationdevicescontrolandcheckoutlist>.Thereare3kindsofcalibrationtobedefined.OutsidecalibrationInsidecalibrationandexemptcalibration.所有接或接相最終品質(zhì)的設(shè)必須含在計器具理臺及校計劃內(nèi)。公內(nèi)量分為校量、內(nèi)量具免校具三.Outsidecalibration外部校Allmonitoringmeasurementequipmentspurchasedexternalandusedtoproductsandprocesscharacteristic,likecaliper,dialindicator,threadgauges,micrometers,CMMetc.needtocalibratedbyoutsideintelligenceorganizationwithcalibrationreport.Calibrationcycleisnormallyoneyearifhavespecialrequirementwillfollowit.Detailedpleasegaugelist.外部買的于測產(chǎn)品過程性有的通檢測具如卡、百表、紋規(guī)千分尺、坐標(biāo)量機(jī)。均外部資質(zhì)機(jī)構(gòu)行校，并供驗報。校周期般為一年如有殊要依要執(zhí)行具體《計器具理臺及校計》。Insidecalibration內(nèi)部校Inspectionjigsmadeinternalarecalibratedbyqualifiedinspectorfollowingrelateddrawings.Cycle

timeofinternalcalibrationdependingontheusageofjig.Detailedpleaseseegaugelist公司部制測量品的測量公內(nèi)部有資的人依據(jù)應(yīng)圖紙范檢量具相關(guān)尺寸內(nèi)部驗周視具的量使用況而。具見計量具管臺帳校驗計劃。Nocalibrationrequiredifequipmentis無校驗設(shè)備：-Productionequipment,notmeasuringortestingequipment.非監(jiān)和測的生設(shè)備.-Equipmentisonlyforcomparison.Butitisnecessarytocheckperiodically.僅用參照設(shè)備但其須定檢查.-Theequipmentthatitsmeasurementjustreference,ithasanotherprocesstocontroltheresult.為檢設(shè)備其檢結(jié)果用作考，終判由另的程來制.-Environmentcontrolfacilities,itmakesnodifferencewithproductquality.環(huán)境制設(shè)，其產(chǎn)品量無響1.1.2Informationofequipmentswillbestoredandmaintainedincomputerized<Calibrationdevicescontrolandlist>.所有驗設(shè)的信在電的《量器管理帳及驗劃》進(jìn)行儲和理。1.1.3Numberingdeviceaccordingtothecodingprinciple.根據(jù)碼原進(jìn)行號；附件Appendix11.1.4ListofitemsthatrequiredcalibrationcouldbefoundinCalibrationMasterList.設(shè)備驗清上顯設(shè)備編號1.1.5HistoryandcalibrationduedateforeachequipmentaremaintainedtheCalibrationMasterList.Thereviewoftheequipmentdueforcalibrationwillbeperformedmonthlybasis.校驗史記以及次校時間應(yīng)在驗清上注.每個月設(shè)備校驗況進(jìn)審.1.1.6Ifequipmentistobeoutsideofpermissiblerangeandbecalibrate/fixinternally,itshouldbesentouttothevendorforrepairandcalibration.Ifequipmentisbroken,ithastobereplacednewitem.Productsbyrejectinstrumentshouldbepremeasuredusingeligibleinstruments,andhandleasnonconformanceprocess,keeprelatedrecordalso.

如果備經(jīng)校驗出允的范并且能進(jìn)內(nèi)部準(zhǔn)和修,必送去進(jìn)維修校準(zhǔn).如果設(shè)備經(jīng)損，必立即換新備。有產(chǎn)被不格量具測過需要已檢測產(chǎn)品取應(yīng)的施進(jìn)重新認(rèn)，依不格品理流處理保相關(guān)記錄4.4ExternalCalibration外部校驗4.4.1Measuringequipmentthatbecalibratedinternallyshouldbesenttoaccreditedcompanyforcalibration.無法行內(nèi)校驗設(shè)備須送外部構(gòu)進(jìn)校驗4.4.2ThestandardofexternalcalibrationlabmustbetraceabletoclassIlormorehighclassindependentlab.外部準(zhǔn)實室的準(zhǔn)必能溯到二實驗或更等的實室。4.4.3FiIlinthequalifiedlabelandpasteitonthedevice,UpdatethecalibrationinformationinCalibrationMasterList.校驗填寫部的格標(biāo)并貼量測器本上，更校驗備清上的息。4.4.4AllexternalcertificatesshouldberetainedinExternalCalibrationCert,filerecords.保持有部校驗報告書，資記。4.5InternalCalibrationmanagement.內(nèi)部驗管4.5.1Selectsuitablemeasuringequipment選合適測試備Allequipmentsbeusedformeasuring,usermusttakeequipmentmanual,specification,tolerance,environmentcondition,traceability,precision,accuracyforreference.AndQAmakesurethatitmustbecalibratedornot,inordertomeettheproductspecification.用來測的備，用者該取設(shè)備冊，范，量差，存環(huán)，追標(biāo)識，精以及參準(zhǔn)確。工程師確定否進(jìn)校準(zhǔn)判斷否符其產(chǎn)規(guī)范4.5.2Confirmcalibrationperiod確校驗期Calibrationpeoplebuildupperiodofequipmentsaccordingtoitsstability,precision,frequencyofuse,conditionandmanual.Calibrationcycleisnormallyoneifspecialrequirement,willfollowit.Detailedpleaselist.校驗根據(jù)備的定性精度使用率、存環(huán)及用手來確其校周期。驗周期般為年，有特要求要求行。體見驗具清；

Calibrationpeoplecanadjustcalibrationperiodaccordingtocalibrationreport.檢驗可以據(jù)校報告當(dāng)對驗周進(jìn)行整。4.5.3Calibrationimplementation實施驗Calibrationpersonwhodoesinternalcalibrationmustgetrelatedskilltrainingorcertificate.Andshouldbetrainedperiodically.內(nèi)部驗人必須過相的技培訓(xùn)證書并且訓(xùn)定期進(jìn)行Shouldestablishcalibrationoperationprocedure.建立應(yīng)的驗規(guī)。Writedownthecalibrationreportcalibrationfinished.檢驗后寫《具收報》。Alltheitemsthatarecalibratedshouldbelabelledwithcalibrationsticker.Informationsuchasequipmentnumber,checkdate,duedateandcheckbyshouldbevisibleonthecalibrationsticker.校驗的設(shè)應(yīng)在備本上貼校驗格標(biāo)，注設(shè)號碼校驗期，次校驗日等。Ifcalibrationfails,calibrationpeoplemuststicktheStopusing”LabelontheequipmentissuetheAbnormalNoticetouser.Theuserandrelevantdepartmentshoulddocorrectiveactions,andTraceproductinthepassingtime,andasnonconformanceprocess,keeprelatedrecordalso.如果驗失，校人貼“停使用標(biāo)簽提交常告給用者使用以及相關(guān)部門采取正措，對前使過此具檢過的品行追確認(rèn)并不合品理流程理，存相的記；Ifthemasterequipmentisoutofcalibration.Calibrationpeopleadjustorrepairandcalibratetheequipment,thencheckotherequipmentthatcalibratedbythismasterequipment.Ifresultoutofspecification.Calibrationpeopleshouldadjustorrepairandcalibrateagain.Keeprecordandinformuserandrelevantdept.如果用的準(zhǔn)設(shè)超出范，驗人對其行調(diào)、復(fù)和新校，并其校驗過其他備進(jìn)重新查。果這設(shè)備出規(guī)，檢人必要它們次驗。持錄

并通使用和相部門Calibrationmustfinishcalibrationwithin7workingdays.+/-7daysallowedbetweenforcalibrationdue校驗員必在7個工作內(nèi)成校。所校驗期允偏差+/-7天Whencalibrationfinished,CalibrationMasterListshouldbeupdatedfollowtheresult.校驗成后時更校驗理清的信。Allrelatedrecords,reports,documentsshouldbekeptuntilequipmentscraped.所有關(guān)記、報、文應(yīng)保至設(shè)報廢4.5.4UseandMaintainMeasurementinstruments計器具使用保養(yǎng)TheusershallapplythemeasuringinstrumentsqualitydepartmentandfillinFN-QA-026Equipmentregistratio∩∕receiveform使用門到質(zhì)部領(lǐng)測儀器填寫《FN-QA-026量具領(lǐng)登記》。Theusershallchecktheeffectivedateandtheinstrumentsworkwellbeforeuse.使用部門在使前應(yīng)確認(rèn)器在效期，且常工。.Alloftheanomalycaseappearoftheinstrumentmusthavetoverifybygaugerforexampleincludingdroponthefloor,impactwithothermetalandetc.所有量器出現(xiàn)異常況都須經(jīng)計量的核確方可用，如包掉落在地或與他金發(fā)生撞等響。Theusershallusetheinstrumentsrightlyandkeepthemintheproperplacetopreventdamage.使用門正使用器，存在當(dāng)?shù)姆椒罁p壞Theusershallcheckandmaintaintheinstrumentsdaily,andkeepthemclean.使用門負(fù)責(zé)日的保檢查保持器的潔。4.5.5RepairandscrapforMeasurementinstruments測儀器維修報廢Iffindnonconformanceincalibrationornormalproduction,theuserfillin<Equipment

∪∪Maintenanceest>andsendtoqualitydepartmenttochangeinstruments.儀器驗中日常產(chǎn)中現(xiàn)儀不良使用門填《設(shè)維修請》通知質(zhì)，更換合的量。Ifpossibledepartmentsrepairortosuppliertorepair,andthencalibrate.Ifnotrepairable,theinstrumentswillbescrapedandredIabelqualitydepartmentfillin<toscrapandupdatethecontrollist.如果維修品質(zhì)進(jìn)行單修或委外部應(yīng)商修維修經(jīng)校合格以重使用。果不維修儀器行紅標(biāo)識填寫FNQA廢，更新單。

-025《具損報廢申單》申請報Forthesuspectproducts,QualityfillsinNonconformingproductsdisposalForm>todispose.Iftheproductshavebeenshipped,Qualitycallrelateddepartmentstoevaluatetheriskanddecidetheplan,informcustomers.對因器障造的可產(chǎn)品品質(zhì)填寫不合品處單》調(diào)理。產(chǎn)品已經(jīng)貨，品質(zhì)召集關(guān)部進(jìn)行險評，確行方案必要時通知戶4.6ProductConformance產(chǎn)品一性4.6.1Intheeventofequipmentisfoundtooutsidepermissiblerange,suspectedproductshallre-inspectedre-validatedforitsconformancetotheproductspecification.Thedispositionofproductwouldbeaccordingrelatednonconformingproductsprocedures.如果測設(shè)超出許范，受影響產(chǎn)品須進(jìn)重檢驗確認(rèn)否滿產(chǎn)品范。異常品的理可考不格品理的關(guān)程。4.6.2Ifproductalreadybe