BRCGLOBALSTANDARDFOODISSUE4-CHECKLISTNOTESInthe'Met'columnthereareonlythreepossibletypesofentry:l'Y'(atickisanacceptablealternative)indicatingYesforcompliancel'N'(acrossisanacceptablealternative)indicatingNoforanoncompliancel'NA'indicatingthatthatrequirementisnotrelevanttothistypeofoperationandsoneither'Y'or'N'ismeaningfulForall'N'orcrossentriesindicatinganon-conformityagainstarequirementatthelevelbeingsoughttheremustbeaCARissued.Forall'NA'anentrymustbemadeinthechecklistandtheEvaluationReportexplainingthereasonforbeingnotapplicable.Forclausesincompliance,itmaybeconsideredthereareopportunitiesforimprovementthatshouldbereported..ThecommentscolumnshouldbeusedtoindicateCRITICAL/MAJOR/MINORCAR.ClauseRequirementMeComments&Observationst1.HACCPSYSTEMThebasisofthecompany’sfoodsafetycontrolsystemshallbeaHACCPPlanwhichshallbeFUNDAMENTALsystematic,comprehensive,thorough,fullyimplementedandmaintainedandshallbebasedontheCodexAlimentariusHACCPprinciplesandreferenceshallbemadetorelevantlegislation,codesofpracticeorguidelines.SeniorManagementcommitment&implementationinQMSHACCPsystem–multidisciplineteamUseofconsultants1.11.2Daytodaymanagement1.3TeamLeadercompetenceTeammemberstrainingandexperienceSupportprogrammese.g.QAandGMPHACCPprinciplesused...61.6.7HazardanalysisCCPsCriticallimitsMonitoringcontrolofCCPsCorrectiveactionsValidationandverificationDocumentationClauseRequirementMeComments&Observationst1.7Riskanalysis.1.92.Occurrenceandseverity.QualitativeandorquantitativeevaluationMicro-organismsApplicability,practical,effectiveandreviewedConformanceandcorrectiveactionrecordsQUALITYMANAGEMENTSYSTEM2.1QualityManagementSystem-GeneralRequirementsThecompanyshallhaveadefinedQualityManagementSysteminrelationtotheStandardthatisestablished,documented,implemented,maintained,reviewedandwhereappropriate,improvedFUNDAMENTAL2.2QualityPolicyStatementThecompanyshallhaveaclearlydefinedanddocumentedauthorisedqualitypolicystatement..22.2.3Company’sintentionsSeniormanagementcommunicationUnderstandingofpolicyCommunicationsandreviewQualityManualThecompanyshallhaveaQualityManualwhichstatesthecompany’scommitmenttoqualityandhasascopewhichcoverstherequirementsofthisStandard..22.3.3ImplementationWorkingmethodsandpracticesAvailabilityClauseRequirementMeComments&Observationst2.4OrganisationalStructure,ResponsibilityandManagementAuthority.Thecompanyshallhaveanorganisationalstructurewhichensuresjobfunction,responsibilityandreportingrelationshipsofthosestaffwhoseactivitiesaffectproductsafety,legalityandqualityareclearlydefinedanddocumented.Directorsresponsibilities.2Responsibilitylevels&jobdescriptionsAbsenceofkeystaff.Informationsupport&monitoringofQMSUpdatesonlegislation,foodsafety,technicaldevelopmentsetcDescriptionofdutiesorworkinstructionsManagementCommitmentThecompany’sseniormanagementshallbefullycommittedtothedevelopment,implementationandimprovementoftheQualityManagementSystem..2QualityobjectivesProcessforidentificationofsafetyorlegalissuesDocumentation2.6CustomerFocusThecompany’sseniormanagementshallensurethatprocessesareinplacetodeterminetheircustomer’sneedsandexpectations,toclearlydefinetheirrequirementsandensurethattheserequirementsarefulfilled.PerformanceindicatorsManagementReviewThecompany’sseniormanagementshallreviewtheeffectivenessoftheQualityManagementandHACCPSystemsatplannedintervals.ThereviewshallensureacriticalevaluationoftheSystems’suitability,adequacyandeffectiveness,andidentifytheneedforchange.2.7.1RecordsClauseRequirementMeComments&Observationst2.7.3ReviewtoincludelAuditslCustomerfeedbacklProcessperformancelProductconformitylPreventative&correctiveactionslReviewofmanagementreviewslChangesonQMSlRecommendations2.82.9ResourceManagementThecompany’sseniormanagementshallprovidealltheresourcesrequiredtoimplementandimprovetheprocessesoftheQualityManagementandHACCPsystems.InternalAuditThecompanyshallauditthosesystemsandprocedures,whicharecriticaltoproductsafety,legalityandqualitytoensuretheyareinplace,appropriateandcompliedwith.Appropriatenessoffrequency..0Competencyofauditors.Recordofinternalaudits,correctiveactionsandverificationResultstothoseconcernedcorrectiveactionsandtimescalesRecordtodemonstratecompliancePurchasingThecompanyshallcontrolallitspurchasingprocesses,whicharecriticaltoproductsafety,legalityandqualitytoensureproductandservicesprocuredconformtodefinedrequirements.2.10.1SupplierApprovalandPerformanceMonitoringThecompanyshalloperateproceduresforapprovalandthemonitoringofitssuppliersDocumentedsupplierapprovalprocedureExceptionsClauseRequirementMeComments&ObservationstCriteriaandstandards.lIn-housecheckslCertificatesofanalysislSupplierinspectionPerformancereview2.11GeneralDocumentationRequirementsThecompanyshalldocumentprocedurestodemonstratecompliancewiththeStandardandshallensurethatalldocumentsnecessarytodemonstratetheeffectiveoperationandcontroloftheprocessesunderpinningthiscomplianceareinplace.2.11.1DocumentationControlThecompanyshallensurethatalldocuments,recordsanddatacriticaltothemanagementofproductsafety,legalityandqualityareinplaceandeffectivelycontrolled.AuthorisedandversionLegible,unambiguous,detail,correctapplicationandaccessibleReasonsforchangesoramendmentrecordedObsoletedocumentationRetentionofdocumentsandrecords2.11.2SpecificationsThecompanyshallensurethatappropriatespecificationsexistfor:lrawmaterials(includingpackagingmaterials)lfinishedproductslintermediate/semiprocessedproducts(whereappropriate)lanyproductsorservicewhichcouldaffecttheintegrityofthefinishedproductClauseRequirementMeComments&Observationst2.11.3ProceduresThecompanyshallhave,andoperateinaccordancewithwrittendetailedprocedures,instructions,andreferencedocumentstocoverallprocessescriticaltoproductsafety,legalityandquality.2.11.4Legibility,unambiguousandaccessibledocumentRecordKeepingThecompanyshallmaintainrecordstodemonstratetheeffectivecontrolofproductsafety,legalityandquality.Legibilityandgenuine.Collation,review,maintenance,storageandretrieval2.12AmendmentauthorisationCorrectiveActionThecompanyshallensureproceduresexisttoinvestigatethecauseofsignificantnon-FUNDAMENTALconformityagainststandards,specificationsandprocedures,whicharecriticaltoproductsafety,legalityandquality.CorrectiveactionstakenPlanresponsibilityDocumentedresponsibilityandaccountability.Traceability2.13Thecompanyshallhaveasystemwiththeabilitytotracematerials(includingprimarypackagingmaterials)fromsourcethroughallstagesofprocessinganddistributionofthefinishedproducttothecustomer.FUNDAMENTALAuditorNote:UndertakeTraceabilityChallengeSystemtestingIdentitypreservationReworkClauseRequirementMComments&Observationset2.14ManagementofIncidents,ProductWithdrawalandProductRecallThecompanyshalleffectivelymanageincidentsandhaveeffectiveproductwithdrawalandproductrecallproceduresinplace.2.14.1Writtenguidanceonwhatconstitutesan“incident”andreportingprocedure4.3CustomersnotificationDocumented‘ProductRecall’procedureAppropriateness,formalisationandreviewTestingofprocedureCorrectiveactionandreviewComplaintHandling4.52.15Thecompanyshallhaveasystemforthemanagementofproductcomplaints.AppropriateactionsUseofcomplaintdata5.23.FACTORYENVIRONMENTSTANDARDS.1ExternalEnvironmentStandardsLocationThesiteshallbelocatedandmaintainedsoastopreventcontaminationandenabletheproductionofsafeandlegalproducts.LocalactivitiesSiteboundaries.3.1.2PerimeterandGroundsAllgroundswithinthesiteshallbefinishedandmaintainedtoanappropriatestandard.GoodorderandwellmaintainedCleanandunobstructedarea.ProceduresOutsidestorageDrainageClauseRequirementMeComments&Observationst3.2InternalEnvironmentStandards3.2.1Layout,ProductFlowandSegregationPremisesandplantshallbedesigned,constructedandmaintainedandproceduresshallbeinplacetocontroltheriskofproductcontaminationandtocomplywithallrelevantlegislation.FUNDAMENTALSitesecurityandauthorisedaccessProcessflowBarriersorproceduresforcontaminationSystemsofworkingSegregationdesignEffectivesegregationforspecifichandlingrequirementsHighriskareasHighcareareasTransferpointshighrisk/lowrisk0Impactofonsitelaboratory1Washingandcleaningsegregationoftraysandutensils2Sufficientspace3.2.2Fabrication-RawMaterialHandling,Preparation,Processing,PackingandStorageareas.Thefabricationofthesite,buildingsandfacilitiesshallbesuitablefortheintendedpurpose.Walls.Walldesign,construction,finishandmaintenanceFloors.Design,imperviousandmaintenance.Drainagedesignandmaintenance.Drainsfromlaboratories.Floorfalls4ClauseRequirementMeComments&ObservationstCeilings/overheads.Ceilingsandoverheadsdesign,construction,finishandmaintenance.AccesstofalseceilingsWindows.Openwindowdesign.Protectionforglasswindowbreakage.Doors.ExternaldoorsLighting.Lightingforworkareas.Protectionofbulbsandstriplights.AirConditioning/Ventilation.Adequateventilation.Maintenanceofscreenedorfilteredairequipment.Positiveairpressure33.3ServicesAllservicestoandwithintheproductionandstorageareasshallbedesigned,constructed,maintainedandmonitoredtocontroltheriskofproductcontamination.WatersupplyEquipmentEquipmentshallbesuitablydesignedfortheintendedpurposeandshallbeusedsoastominimisetheriskofcontaminationofproduct.Equipmentspecification,maintenanceandoperationEquipmentaccess.2ClauseRequirementMeComments&Observationst3.5MaintenanceAsystemofplannedmaintenanceshallbeinplacecoveringallitemsofequipmentwhicharecriticaltoproductsafety,legalityandquality.ProgrammefornewequipmentandplantImpactofmaintenanceTemporaryrepairs.Cleaningorreplacinglightfittingsandglass..43.6StaffFacilitiesStafffacilitiesshallbedesignedandshallbeoperatedsoastominimisetheriskofproductcontamination....63.6.7Designatedchangingfacility,andclothingHandwashingfacilitiesToiletsSmokingareasCateringfacilitiesStorageofstafffoodSitingofchangingfacilities.93.7SpeciallydesignatedchangingfacilitiesforhighriskareasOutdoorclothingandpersonalitemsstorage.PhysicalandChemicalProductContaminationRiskAppropriatefacilitiesandproceduresshallbeinplacetocontroltheriskofphysicalorchemicalcontaminationofproduct..2StoragefacilitiesforchemicalsContaminationauditsandcorrectiveaction.4AllglassandsimilarmaterialregisterWrittenproceduresforhandlingglassandhardclearplasticbreakage.6IncidentreportsIncompatiblematerials3.7.7UseofwoodClauseRequirementMeComments&Observationst3.8HousekeepingandHygieneHousekeepingandcleaningsystemsshallbeinplacewhichensureappropriatestandardsofhygienearemaintainedatalltimesandtheriskofcontaminationisminimised.DocumentedcleaningschedulesFUNDAMENTAL...63.9CleaningpracticesCleaningandhousekeepingpracticeandrecordsCleaningchemicalsVerificationofcleaningandsanitationeffectivenessDisinfectionprocessesWaste/WasteDisposalThereshallbeadequatesystemsforthecollection,collationanddisposalofwastematerial.MinimisationofaccumulationofwasteMeetlegislativerequirements.UseoflicensedcontractorsExternalwastecollectioncontainersandcompactorsThirdpartyusagefortrademarkedmaterials..43.10PestControlTheCompanyshallberesponsibleforminimisingtheriskofpestinfestationonthesite.3.10.1CompetentpestcontrolPestcontrolplan/diagramIdentificationandcheckingofprocessequipmentUseofresultsdataDetailedrecordsElectricflykillersand/orpheromonetrapsScreensandtrapsondrains0.9CheckingforpestinfestationonincomingrawmaterialsStorageareas3.10.10DocumentationonsafeuseClauseRequirementMeComments&Observationst3.11TransportAllvehiclesusedforthetransportationofrawmaterials(includingpackaging)tothepremises,andthedispatchofintermediate/semiprocessedproductandfinishedproducttothecustomerorfurtherstoragefacilitiesshallbesuitableforthepurpose,maintainedingoodrepairandinahygieniccondition.Whereacompanyemploysthird-partycontractors,alltherequirementsspecifiedwithinsection3.11shallbedefinedwithinacontractandeffectivelymanaged.DocumentedmaintenanceandhygienicproceduresProceduresforsecureconditionsProceduresforcrosscontaminationAdequacyofrefrigeratedtransportProceduresformcontractrefrigeratedtransportRefrigeratedtransporttemperaturedataloggingdevicesProceduresfortaintuptakeProtectionofmaterialduringloading/unloading4.BreakdownproceduresPRODUCTCONTROL4.1ProductDesign/DevelopmentAhazardanalysisstudyshallbeundertakenduringtheproductdesign/developmenttoidentifyandassessallpotentialsafetyhazardsandassociatedrisks.Factorytrialsandtesting..44.1.5LegallabellingDocumentedproductdesign/developmentprocessEstablishmentofshelflifeDocumentedshelflifetrialsClauseRequirementMeComments&Observationst4.2HandlingRequirementsforSpecificMaterialsWhererawmaterialsandfinishedproductrequirespecialhandlingprocedures(e.g.knownallergies,productcertifiedtoorganicorassuredstandardstatus),handlingrequirementsshallbeinplacetoensurethatproductsafety,legalityandqualityaremaintained.RiskassessmentFUNDAMENTAL.2CrosscontaminationReworkproceduresimplementedMetalDetection/ForeignBodyDetectionThecompanyshallensureallnecessarystepsaretakentoidentify,avoid,eliminateorminimisetherisksofmetalorforeignbodycontamination.CCPdeterminationofneedandsituation.2Bestpracticeandcriticallimits4.3.3Detectorincorporatesoneofthefollowing:1.Alarmorbeltstop2.Automaticrejection3.LocationandsegregationCorrectiveactionproceduresfollowingdetectionProceduresforoperation,monitoringetc.Proceduresfollowingfailureofdetector.54.4ProductPackagingProductpackagingshallbeappropriatefortheintendeduseandstoredunderconditionstominimisetheriskofcontaminationanddeterioration.Specificationprocedures.2Compliancewithfoodsafetylegislation.4StorageHandlingprocedures.Recordsoffailures.64.4.7Part-usedmaterialColouredlinersProductcontaminationduetopresenceofstaplesClauseRequirementMeComments&Observationst4.5ProductInspectionandAnalysisThecompanyshallundertakeorsubcontractinspectionandanalyseswhicharecriticaltoconfirmproductsafety,legalityandquality,usingappropriateprocedures,facilitiesandstandards.4.5.1RiskassessmentforincomingmaterialsDocumentedproceduresSuppliersevidence.PrinciplesofISO17025forlaboratoryProceduresforreliabilityoftestresults.CompetencyoftesterStockRotationProceduresshallbeinplacetoensurematerialsandproductsareusedinthecorrectorderandwithintheallocatedshelflife.Receiptdocumentsand/orproductlabellingcorrectstockrotationProductReleaseThecompanyshallensurethatproductisnotreleasedunlessallreleaseprocedureshavebeenfollowed.Productreleasedbyauthorisedpersonnel.ControlofNon-ConformingProductTheCompanyshallensureallout-of-specificationproductisclearlyidentified,labelledandquarantined...4Proceduresforthecontrolofnon-conformingmaterialControlofcontaminatedproductCorrectiveactionsNon-conformingproducthandlingClauseRequirementMeComments&Observationst5.PROCESSCONTROLThecompanyshallbeabletodemonstrateeffectivecontrolofalloperationsundertaken.ControlofOperations5.1Thecompanyshalloperateproceduresthatverifythattheprocessesandequipmentemployedarecapableofproducingconsistentlysafeandlegalproductwiththedesiredqualitycharacteristics.FUNDAMENTAL5.1.1Initialworstcaseconditionsvalidation..5OngoingvalidationControl,monitoringandrecordingofphysicalandchemicalcontrolOnlineprocessmonitoringUseofrecordinglinkedfailurealertsystemorcontinuousrealtimemeasurementslinkedtoautomaticalarmsystemRe-establishmentafterchanges.75.2ProceduresforequipmentfailureorprocessdeviationtoensureproductsafetyQuantityControlThecompanyshalloperateaquantitycontrolsystemwhichconformstolegalrequirements(whereproductissold)andanyadditionalrecognisedindustrysectorcodesorspecifiedcustomerrequirement..25.2.3FrequencyandmethodologyofquantitycheckingImportedpre-packedmaterialcomplianceMeetingcustomerspecificrequirementsClauseRequirementMeComments&Observationst5.3CalibrationandControlofMeasuringandMonitoringDevicesThecompanyshallidentifymeasuringequipmentusedtomonitorcriticalcontrolpointsandproductsafetyandlegality.Theidentifiedmeasuringequipmentshallbecalibratedtoarecognisednationalstandard.Whereatraceablecalibrationisnotpossiblethecompanyshalldemonstratethebasisbywhichstandardisationiscarriedout.CalibrationoradjustmenttoensureaccuracyRecordsofcalibrationandverificationIdentificationandmarkingofdevicesPreventionofunauthorisedadjustmentProtectionfromdamageetc...66.Proceduresduring