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首页 Supplier Questionnare - Section E Quality Q._mo…

Supplier Questionnare - Section E Quality Q._modified.doc

Supplier Questionnare - Section…

放羊的老虎
2018-09-10 0人阅读 举报 0 0 0 暂无简介

简介:本文档为《Supplier Questionnare - Section E Quality Q._modifieddoc》,可适用于医药卫生领域

SupplierQualityQuestionnaireSupplierQuestionnareSectionEExtendedQualityQuestionnairePageofEExtendedQualityQuestionnaireMaterialBrandNameChemicalName(ifapplicable)ProductCode               GeneralInformationArecustomerauditsandorinspectionsbyagenciespermittedYesFORMCHECKBOXNoFORMCHECKBOXIsthedecisiontoreleaseorrejectaproductforsaleindependentfromproductionYesFORMCHECKBOXNoFORMCHECKBOXWhoissigningtheCertificateofAnalysis(AnalyticalReport)     Whoisresponsibleforthefinalproductrelease     Whoisresponsibleforcontactswithusconcerningqualitymatters     Whatkindofproductdoyoumanufacture·BulkrawmaterialsYesFORMCHECKBOXNoFORMCHECKBOX·BulkrawmaterialsforpharmaceuticalsYesFORMCHECKBOXNoFORMCHECKBOX·ActivepharmaceuticalingredientsYesFORMCHECKBOXNoFORMCHECKBOX·TechnicalproductsYesFORMCHECKBOXNoFORMCHECKBOX·PackagingmaterialYesFORMCHECKBOXNoFORMCHECKBOX·OthersYesFORMCHECKBOXNoFORMCHECKBOXPlease,specify:Please,giveabriefflowdiagramoftheprocess,includinginformationaboutwhereinprocesscontrolsareperforlYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·IsthereaprocedureconcerningchangeofsoftwareanditscopyingYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·IsthesecurityofsoftwarecontrolledYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyoucontractoutanyofthefollowingservicesInstrumentCalibrationYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXPreventativeBreakdownMaintenanceYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXProductionandProcessControlIsyourmanufacturingprocessvalidatedYesFORMCHECKBOXNoFORMCHECKBOXIfnot,doyouhaveplanstodosoYesFORMCHECKBOXNoFORMCHECKBOXIfyoudo:whatisyourtargetdateforcompletion     HowdoyoudefineyourlotbatchHowandbywhomarelotbatchnumbersassignedWhatisyournormallotbatchsizeDoeseachlotbatchhaveanidentificationnumberYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIf,forcapacityreasons,youcombinematerialcomingfrommorethanoneparticularpieceorpartofprocessequipmentintoonelotbatch:IsthelotbatchbeinghomogenisedpriortopackagingYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIsthehomogenisationoperationvalidatedYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyoumanufactureaccordingtoawrittenprocedureforeachproductsuppliedtothemarketYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXAretheseproceduresapprovedbyQAYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyouhaveabatchrecordforeachbatchlotmanufacturedYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIfyes,dothebatchrecordsdetailthefollowing:·Description,LotNumberQuantitiesofMaterialusedYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·ProcessingConditions(Temperature,Timesetc)YesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·TheidentificationofthePersonwhoperformedtheparticularstepYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·ResultsofanyInprocesstestsYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·AlldeviationsfromstandardconditionsYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·AllcleaningoperationscarriedoutbeforeafterbatchmanufactureYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIfyes,forhowlongdoyoukeepthebatchrecordsYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIfyes,aretheserecordsformallycheckedandapprovedbyQAYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyoumaintainlotseparationduring·ManufacturingYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·PackagingYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·StorageYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyoumaintainrecordsofuse,maintenanceforprocessequipment,inordertodemonstratethetraceabilityinbatches,productprocessedandpersonnelYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXArecomputersusedtostorerecordsofmanufacture,testing,storageordistributionfortheproductyousupplyYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIfyes,havethesecomputersystemsbeenvalidated(iehavethecompletelifecyclesofthesystemsbeenassessedanddocumentedincludingstagesofplanning,specifications,programming,testing,commissioning,documentation,operation,monitoringandmodifying)YesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoallproductcontainersbearidentificationlabels,egstatingbatchlotnumber,productnameetcYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIsthereexpiryorretestdatesdefinedforallmaterialYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIstherestorageconditionsdefinedforallmaterialYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIstheproductidentifiablethroughoutthemanufacturingprocessYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIstraceabilityofallrawmaterialsused,maintainedthroughoutmanufactureYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIsthereaprocedureinplacetopreventcrosscontaminationYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXArelineclearancesundertakenbetweenproductchangesduringmanufacturingandlabelling(ieWhereavarietyofproductsaremanufacturedononesite,doyoucarryoutanindependent,recordedcheck,immediatelypriortoaproductionruntoverifytheareasarefreefrompreviousstartingmaterials,productsdocumentationandwasteandthatitisfitforuse)YesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyouusededicatedequipmentfortheproductionoftheproductinquestionYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIfno,pleaseprovidedetailsofotherproducttypesmanufacturedusingthisequipment:     IstestingorinspectionperformedbetweenprocessesormanufacturingstagesYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIstestingorinspectionperformedonfinishedproductsYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXArerejectedlotsidentifiedassuchandseparatedYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyouperformafailureinvestigationincaseofarejectYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIsreprocessingofrejectedlotsdocumentedYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyouhaveaprocedurecoveringreworkreprocessingorrecoveryofmaterialYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIsnonconformingfinalproducteverblendedwithconformingproducttobringitintospecificationYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIsthereadocumentedprocedurethatclearlydefineswhenblendingofnonconformingproductisallowedYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXHowlongdoyoukeeptheanalyticalandproductionrecords(numberofyears)YearsDoyouhaveplantshutdowns(holidays,maintenance)YesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIfyes,whichone(s)FORMCHECKBOXmainFORMCHECKBOXholDoyouhavemanufacturingalternativesfallbackYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXHowmanyweeksofinventorydoyouhavefortheproduct(s)involved:·Rawmaterials·Semifinishedproduct··FinishedproductMaterialsControlDoyouhaveanapprovedsupplierlistYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyouhaveagreementsinplacewithallyoursuppliersthatrequirethemtonotifyyouofanychangeinrawmaterialorthemanufacturingprocessoftheproductsuppliedYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyouhavewrittenspecificationsforallincomingrawmaterialYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXWhoisresponsibleforestablishingandapprovingthespecificationsofrawmaterials     Doyourequireamanufacturer’scertificateofanalysisforallmaterialreceivedinthecompanyYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXAreCertificatesofAnalysisroutinelycomparedagainstawrittenspecificationYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyouroutinelytestreceiptedmaterialstoverifyconformancewiththesuppliercertificationYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyouhaveproceduresforthecontrolofrawmaterialsYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXArerecordskeptthatshowfulltraceabilityofrawmaterialsYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyoumaintaininformationrecordsforrawmaterialswhichincludethefollowing:·YourlotIdentityYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·SuppliersLotNoYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·DateofReceiptYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·QuantityYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·SuppliersnameYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·ShelfLifeYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·TestResultsYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·SpecificationYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·AcceptedRejectedYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·RetainedSampleYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXPleasedescribehowmaterialisissuedfromstock:     DoyouhavedefinedareasforReceipt,Identification,SamplingandQuarantineofincomingmaterialsYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXArescheduledstockchecksperformedYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyouhaveareworkreprocesspolicyYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXQualityControlIsQualityControl(QC)independentofProductionYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXPleasedescribetheQClaboratoryfacilitiesandtheteststheselaboratoriesarecapableofperforming:     ArerecordskeptofallsamplesthataresubmittedtothelaboratoriesYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIfso,dotheserecordsincludethefollowing:·DatesamplereceivedYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·IdentityofsamplesYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·ResultsoftestingYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·DatesampletakenYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXArethereformalwrittenproceduresforallperformedtestsYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXAretheanalyticalmethodsvalidatedYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXArecontrolsamplesroutinelyrunwithassaysYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXAreanalyticalcalculationscheckedbyasecondpersonYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyouperformtrendanalysisonanalyticalresultsYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXAretheresultsofreferencestandardtestingmaintainedonfileYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIsthereaprocedurefordocumentingandinvestigatingoutofspecificationresultsYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyouuseanycontractlaboratoriesYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXHaveyouqualifiedevaluatedthesecontractlaboratoriesYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXWhattypesoftestingiscontractedout     Arequalitystandardsorwrittencontrolproceduresavailablefor:·StartingmaterialsYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·InprocesscontrolYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·Physicalidentificationatallstages(eglabellingofsemifinishedproducts)YesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·FinishedproductsYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·MicrobiologicalcontrolYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXArerecordskeptofallcontrolresultsYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIfyes,forhowlongdoyoukeepthoserecordsYearsIsyourcriticalanalyticallaboratoryequipmentfullyqualifiedYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIsthereamaintenanceplanprocedureforlaboratoryequipmentYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIfyes:DoyouhaveacalibrationschemeYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyouhavecalibrationinstructionsYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyoukeepallrecordsofcalibrationperformancesYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoesanylaboratoryequipmenthavesoftwarecontrolYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIfyes:IsthesoftwarevalidatedYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXAremodificationsofsoftware(oritsuse)implementedbylaboratorypersonnelYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIsthereaprocedureconcerningchangeofsoftwareanditscopyingYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIsthesecurityofsoftwarecontrolledYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXAresamplesofendproducttakenbyappropriatetrainedpersonnelYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXWhichsamplingplandoyouuse:·Forstartingmaterials·ForfinishedproductsDoyouanalyseeachsampleYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyoukeepretainsamplesofeachlotYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXForhowlongdoyoukeepretainsamplesYearsIsthereaprocedureinplacetoestablishandmanagereferencestandardsYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXQualityAssuranceIsthereanindependentQualityAssurance(QA)departmentwithinthecompanyYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXWhoisresponsibleforevaluationandapproval:·ofspecificationsofendproducts     ·ofcriticalmanufacturingprocessparameters     DoyouhaveprocedurescoveringthereleaseorrejectionofmaterialYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXWhoisresponsibleforreleaseandrejectofyourendproduct     Onwhichqualitydatadoyoubasethereleaseoftheproduct     ArebatchrecordsreviewedapprovedbeforethebatchisdispatchedYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXAredeviationsandnonconformancesinvestigated,documentedandfiledYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyoucommunicatedoubtsregardingthequalityoftheproducttothecustomersYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXEvenwhentheproductisstillwithinspecificationYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXWouldyounotifyyourCustomerofanysignificantdeviationsthatoccurduringmanufacturingYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyouintroducechangesaccordingtoawrittenprocedureYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyouinformyourcustomersaboutchangesYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIfyes,howdoyouinformthem     DoyouwaitforapprovalofcustomersonmajorchangesYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXWouldyounotifyyourCustomerinwritingpriortoimplementingsignificantchangesinanalyticaltestmethods,specificationsormanufacturingproceduresprocess,useofrawmaterialsourceformanimal,humanorvegetableoriginYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXWouldyounotifyyourCustomerinwritingpriortoimplementingmajorchangesinplant,siteofproductionorcontractmanufacturingYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDescribehowseniormanagementisinformedofqualityrelatedissues:     DoyousupplyaCertificateofAnalysiswitheachbatchYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIf‘YES’,willtheCertificateofAnalysisincludeactualanalyticalresultsYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXWillyousupplyaCertificateofSterilizationwitheachbatchYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXPackaging,LabellingandShippingIfcontainersarereused,aretheycleanedviavalidatedcleaningproceduresandinspectedbeforeuseYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXArecontainerlabelsreconciledandthenumberoflabelsprinted,usedanddestroyedrecordedYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIseachbagcontainerlabelledwiththelotbatchnoYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXWilleachbagcontaineronapallethavethelotbatchnoandordescriptionclearlyvisibleonitYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyoukeeprecordsofallshipmentstocustomers,includingbatchnumberandquantityYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyouuseyourowntransportforshippingtocustomersordoyouuseacontractorSupplierOwnedFORMCHECKBOXContractorFORMCHECKBOXNAFORMCHECKBOXIfyouuseacontractor,DoyouhaveanagreedcontractbetweenpartieswhichspecifiesrequiredshippingconditionsformaterialsYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIfyes,havetheybeenevaluatedYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIstheshippingtemperaturecontrolledYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXHavestabilitystudiesfortemperaturecontrolledshipmentsbeenperformedYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXArewritteninstructionsavailableforPackagingcomponentsYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXPackagingoperationYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXLabelsandlabellingYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoesthelabellingprocedureemphasisespecialprecautionstopreventunintentionalmixuporsubstitutionYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyoumaintainlotseparationduringpackagingYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXAreyoupreparedtomeetpackagingandlabellingrequirementsfromyourcustomersYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoesyourlabellingindicate:·NameandqualityYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·ThesiteofmanufacturingYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·ThelotnumberYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·OurordernumberYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOX·OurcodenumberYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyouusereusablecontainersYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIfyes:DoyouhaveprocedurestotakespecialprecautionstoavoidcrosscontaminationinthiscaseYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyouhaveyourowntransportationsystemYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIfyes:DoyouhaveaSQASassessmentreportYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXValiddateoftheSQASreport:               DoyouhaveaQualitySafetyselectionsystemforcontractingcarriersYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyouhavearegularcarrierforyourgoodsYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIfyes:Whatisthenameofthiscompany     Whoisthecarrier'sagent     DoyoucontactyourcustomerincaseofdelayYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoesyourtransportsystemmakeuseofatrackingreportYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoesyourcarrierhaveaQualityManualYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXTowhichnormisthisqualitysystemrelated     IsthissystemcertifiedbyanaccreditedthirdpartyauditingbodyYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIfyes,whichone(s)     DoesyourcarrierhaveaSQASassessmentreportYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIfyes,validdateoftheSQASreport:               DoesyourcarrierprovidedocumentedevidenceofproperstorageconditionsduringtransportationYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXAretransportationsinsuredYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyouhaveoneormoresubstitutecarriersYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIfyes,whichone(s)YesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoesthesubstitutecarrier(s)haveaSQASassessmentreportYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXValiddateoftheSQASreport:               Doesyoursubstitutecarrierhaveacertifiedperson:“Safetyadvisortransportdangerousmaterials(roadrail)”YesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXPleaseencloseacopyofthecertificate:Ref:     DoestheSafetyadvisormakeannuallyreportstothehighestmanagementaboutthetransportactivitiesofthecompanywithrespecttodangerousmaterialsYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXIncaseofliquidproductsYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyouusededicatedtankersYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXDoyourequirecleaningofroadtankersaftereveryuseYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXArecleaningcertificateskeptbythedriverYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXArecleaningcertificatesavailableforinspectionbyusYesFORMCHECKBOXNoFORMCHECKBOXNAFORMCHECKBOXSafety,HealthandEnvironment(SHE)Doyouhaveanoperationalmanagementsystem(s)forSafety,HealthandEnvironment(SHE)YesFORMCHECKBOXNoFORMCHECKBOXIfso,arethesesystemsabasedonaninternationalstandard(ISO)YesFORMCHECKBOXNoFORMCHECKBOXbcertifiedbyaaccreditedthirdpartyauditingbodyYesFORMCHECKBOXNoFORMCHECKBOXDoyouhaveadedicatedorganisationforsafety,healthandenvironmentYesFORMCHECKBOXNoFORMCHECKBOXHowmanypeopleareemployedinthisorganisationHaveyouidentifiedallrelevantSHEaspectsofyouractivitiesandallrelevantlegalrequirementsyouhavetocomplywithYesFORMCHECKBOXNoFORMCHECKBOXDoyouhaveastructuredSHEprogram,whichisregularlymonitoredandupdatedYesFORMCHECKBOXNoFORMCHECKBOXDoesyoursitecomplywithalllicensesunderrelevantlaws(NuisanceAct,EnvironmentalProtectionAct,IntegratedPollutionPrevention,HazardousWaste,etc)YesFORMCHECKBOXNoFORMCHECKBOXArethefollowingsubjectsregulatedbylawandorspecificstandards:·emissionstoairYesFORMCHECKBOXNoFORMCHECKBOX·dischargeofwastewaterYesFORMCHECKBOXNoFORMCHECKBOX·disposalofhazardouswasteYesFORMCHECKBOXNoFORMCHECKBOX·protectionagainstremediationofsoilpollutionYesFORMCHECKBOXNoFORMCHECKBOX·riskcontrolandreductionYesFORMCHECKBOXNoFORMCHECKBOX·nuisancebynoiseodourYesFORMCHECKBOXNoFORMCHECKBOX·occupationalsafetyYesFORMCHECKBOXNoFORMCHECKBOXDoesyoursiteoperateitsownwastewatertreatmentinstallationYesFORMCHECKBOXNoFORMCHECKBOXIsyoursitecontrolledbyregularinspectionsofauthoritiesinthefieldofsafety,healthandenvironmentYesFORMCHECKBOXNoFORMCHECKBOXPleasespecifyIsyourpersonnelinstructedonthehandlingofanykindofhazardousmaterialsthatyouuseandonhowtoactincaseofunwantedeventsYesFORMCHECKBOXNoFORMCHECKBOXDoyouhaveanadequateemergencyresponseplanandorganisationYesFORMCHECKBOXNoFORMCHECKBOXDoyourunSHE(complianceperformance)auditsYesFORMCHECKBOXNoFORMCHECKBOXDoyouhaveacertifiedperson:“Safetyadvisortransportdangerousmaterials(roadrail)”YesFORMCHECKBOXNoFORMCHECKBOXPleaseencloseacopyofthecertificateRef:DoestheSafetyadvisormakeannuallyreportstothehighestmanagementaboutthetransportactivitiesofthecompanywithrespecttodangerousmaterialsYesFORMCHECKBOXNoFORMCHECKBO
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