Approvedby:_______________Date:______________________QP4DocumentandDataControl1.PurposeofthisprocedureThisproceduresetsoutthemethodsbywhichqualitysystemdocumentsanddatawillbecontrolledtoensurecompliancewithABC’squalityrequirements.2.ScopeThisprocedurecoversallqualitysystemdocuments.3.ResponsibilityTheresponsibilityforensuringcompliancewiththedocumentedproceduresrestswiththequalitymanager.4.Keyqualityproceduresa.Thequalitymanagerwillinitiallyissuequalitysystemdocumentstotheappropriatepersonnel.b.TheQualityManual,QualityProcedures,andCalibrationsProcedureshavetheirsectionsidentifiedbyauniquenumber.EachsectionincludesitsqualitysystemelementVersionnumberandRevision“number.”AlsoeachsectionhasanApprovedBy:“signature”andDate.ThequalitymanagerapproveseachsectionbysigningtheApprovedBy:“signature”andcompletingtheDate.c.Workinstructionshaveauniqueworkinstructionnumber.TheyalsohaveanApprovedBy:“signatureandDate.TheQualityManagerapproveseachworkinstructionbysigningtheApprovedBy:“signature”andcompletingthedate.d.MostotherqualitysystemelementswhicharequalityrecordsareidentifiedbyauniqueExhibit“number”orQR“number”.EachofthequalityrecordshasarevisiondatethatisdocumentedinAppendix1oftheQualityProceduresManual.Ifappropriate,thequalityrecordswillincludeadocumentorrecordthathasanapplicableauthorizationorapproval.Ifthequalityrecordisoneofourpreprintedmultipartforms,distributionofthepartsareexplainedontheformsorintheapplicablequalitysystemelementsection.SEW-QP-4Version1Revision0Page1of2ISO-1Document&DataControl5/4/20255/4/2025QP4DocumentControle.Exceptionstob.,c.ord.areexternalrecords(i.e.calibrationsrecordsdocumentedbyandoutsideserviicgroup).Externalrecordsarecontrolledbybeingfiledtogetherintheappropriatelocation.f.ItistheresponsibilityofallpersonneltoinformthequalitymanagerofchangesinthequalitysystembycompletingaCorrectiveActionform.However,itistheresponsibilityofthequalitymanagertomakesurethatchangesinthequalitysystemareproper.Also,he/sheshouldreviewthedocumentedchangeswiththepersonnelinthedesignatedareatomakesurehe/shehasdocumentedthechangesproperly.g.Whenchangesoccurtothesystem,thequalitymanagerwillreissueallsectionsofqualitysystemdocumentsthathavechanged.Eachholderoremployeeresponsibleforthequalitysystemdocumentisresponsibleforensuringthatalloutdatedsectionsaregiventothequalitymanagerattheappropriatetime.He/sheorapersondesignatedbythequalitymanager,willsigntheChangeinQualityDocumentationAcknowledgementReceipts(QR4-1)fortheupdatedsectionandgivetheoutdatedsectiontothequalitymanager.Itistheresponsibilityofthesignee(i.e.,holderoremployeeresponsibleforthequalitysystemdocument)tomakesuretheupdatedsectionisproperlyplacedinhis/herqualitysystemelement.Itistheresponsibilityofthequalitymanagertodisposeofallobsoletesections.ThequalitymanagernotifiesABCemployeesthataqualitysystemdocumentupdatehasoccurredbypostingaNoticeofQualityDocumentationChangeForm(QR4-2)inthewarehouseandthefrontoffice.h.Changestoanysectionofaqualitysystemdocumentareidentifiedbybeingunderlined.Revisionwithinasectionwillrequirere-issueoftheentiresection.i.ThequalitymanagerwillreissueanewversionoftheQualityManual,QualityProceduresManual,JobDescriptionsManual,orCalibrationsManualafterasignificantnumberofchangeshaveoccurredorsoonerifdeemedappropriatebythequalitymanager.Itistheresponsibilityofthequalitymanagertomakesureallholdersreceivenewversionsandtodisposeofallobsoleteversions.j.Thequalitymanagerkeepsamasterlistingofallqualitysystemdocumentstoidentifythecurrentissuesandifapplicable,versions.SEW-QP-4Version1Revision0Page2of2
