AS9100程序-CONTROL-OF-MONITORING-AND-MEASURING-DEVIC

Subject:CONTROLOFMONITORINGANDMEASURINGDEVICESRev.CQP1100EffectiveDate:Page1of5Approvedby:ASCProcedurePRC-DeSotoInternationalProprietary1.0PURPOSE1.1Toensurethatmonitoringandmeasurementcanbecarriedoutinamannerconsistentwithmonitoringandmeasurementrequirements.2.0SCOPE2.1Thisprocedureappliestoallmonitoringandmeasurementdevicesnecessarytoensurevalidresults,includingequipmentsuppliedbythecustomer.3.0RESPONSIBILITY3.1TheCalibrationCoordinator/QualityManagerisresponsiblefor:IdentifyingmonitoringandmeasurementdevicesEnsuringcalibrationsareperformedasprescribedEnsuringmonitoringandmeasurementdevicesarepreventedfromusewhennotcalibratedasprescribedTakingcorrectiveactionwhenmonitoringandmeasurementdevicesfailcalibration.3.2Allemployeesusingmeasuringandtestequipmentareresponsibleforsafeguardingtheequipment.Ensuringthatanitemisnotusedwhenitscalibration/verificationperiodhasexpiredandtoinformtheappropriatepersonneloftheequipment’scontinuedsuitabilityforuse.3.3TheCalibrationCoordinator/QualityManagermaintainsrecordsforeachitemscheduledforcalibration/verification,repairs,andout-of-toleranceequipmentandkeepscalibration/verificationrecordsonfile.4.0GENERAL4.1ThemajorityofASCmonitoringandmeasuringdevicesarecalibratedbyqualifiedsuppliers.4.2CalibrationsuppliersareadvisedofASCcalibrationrequirements.Subject:CONTROLOFMONITORINGANDMEASURINGDEVICESRev.CQP1100EffectiveDate:Page2of5Approvedby:ASCProcedurePRC-DeSotoInternationalProprietary4.3Performanceofcalibrationsuppliersismonitoredtoensurerequirementsarebeingfulfilled.4.4TheCorrectiveandPreventiveActionprocessisusedtoassessandrecordthevalidityofpreviousmeasuringresultswhenequipmentisfoundnottoconformtorequirements.4.5QualityControlisnotifiedwheneverapieceofequipmentrequiringcalibrationispurchased.5.0DEFINITIONS5.1Calibration–processofcheckingtheprecisionandaccuracyofmonitoringandmeasurementdevicesagainstastandard.5.2Recalibration–processofattemptingtobringmonitoringandmeasurementdevicesfailingcalibrationintocompliance.5.3CalibrationCoordinator/QualityManager-individual(s)responsibleformaintaining/schedulingand/orsupervisingthecalibrationsystemfortheASC.6.0PROCEDURE6.1TheCalibrationCoordinator/QualityManageridentifiesmonitoringandmeasurementdevicesrequiringcalibrationandprovidethefollowingforeachmonitoringandmeasurementdevice:a)Equipmenttypeb)Uniqueidentificationc)Locationd)Frequencyofcalibratione)Calibrationmethodf)Acceptancecriteriaforcalibrationresultsg)StandardtobeusedSubject:CONTROLOFMONITORINGANDMEASURINGDEVICESRev.CQP1100EffectiveDate:Page3of5Approvedby:ASCProcedurePRC-DeSotoInternationalProprietary6.2TheCalibrationCoordinator/QualityManagerensurethat:6.2.1Aregisterofmonitoringandmeasurementdevicesrequiringcalibrationismaintained,includinganymonitoringandmeasurementdevicessuppliedbyacustomer.6.2.2Allnewmonitoringandmeasurementdevicesarecalibratedbeforefirstuseandaccordingtodeterminedfrequencythereafter.6.2.3Monitoringandmeasurementdevicesarerecalledwhencalibrationisdueby:6.2.3.1Periodicallyreviewingtheregisterofmonitoringandmeasurementdevicesdueforcalibration6.2.3.2Locatingmonitoringandmeasurementdevicesdueforcalibration6.2.3.3Ensuringthatmonitoringandmeasurementdevicesarecalibratedon,orbeforetheirspecifiedduedate6.2.4Allmonitoringandmeasurementdevicecalibrationsareperformedaccordingtodocumentedcalibrationmethodsunderenvironmentalconditionssuitableforthemonitoringandmeasurementdeviceorintheareawherethedeviceisused.6.2.5Allmonitoringandmeasurementdevicesarecalibratedtonationallyrecognizedstandards,unlesssuchnationallyrecognizedstandardsdonotexist.Wherenonationallyrecognizedstandardexist,thebasisforthestandardusedisidentified.6.2.6Monitoringandmeasurementdevicesnotcalibratedbyduedateareredtagged“Donotuse–calibrationrequired”and/orRedTapedandcalibratedbeforenextuse.6.2.7Unscheduled,orspecialcalibrationsareperformedwhenanyofthefollowingconditionsexist:6.2.7.1AmonitoringandmeasurementdeviceisdroppedorotherwisesubjectedtoinfluencesoutsideitsnormalenvironmentSubject:CONTROLOFMONITORINGANDMEASURINGDEVICESRev.CQP1100EffectiveDate:Page4of5Approvedby:ASCProcedurePRC-DeSotoInternationalProprietary6.2.7.2Monitoringandmeasurementdeviceismodified,reworkedorfixed6.2.8Allmonitoringandmeasurementdevicesaretaggedtoindicatetheircalibrationstatus.Thecalibrationstatustagislocatednearthemonitoringandmeasurementdevice'sstoragelocationifthemonitoringandmeasurementdevicecan’tbephysicallytagged.Tagsinclude:6.2.8.1Identificationnumber6.2.8.2Dateoflastcalibration6.2.8.3Dateofnextcalibration6.2.8.4Individualresponsibleforlastcalibration6.2.9MonitoringandmeasurementdevicesthatarenotnecessarytoensurevalidresultsaretaggedCalibrationNotRequiredorForReferenceOnlyasapplicable.6.2.10Individualsusingmonitoringandmeasurementdevicesensurethat:6.2.10.1Monitoringandmeasurementdevicesfoundtobebeyondthenextrequiredcalibrationdatearenotbeuseduntilcalibrationisperformed.6.2.10.2Monitoringandmeasurementdeviceuse,handlingandstoragearesuchthataccuracyandfitnessforusearemaintained.6.2.10.3Monitoringandmeasurementdevic