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CAC/GL69-2008Page1of16GUIDELINESFORTHEVALIDATIONOFFOODSAFETYCONTROLMEASURESCAC/GL69-2008I.INTRODUCTIONThecontrolofhazardspotentiallyassociatedwithfoodstypicallyinvolvestheapplicationofcontrolmeasuresinthefoodchain,fromprimaryproduction,throughprocessing,toconsumption.Inthecurrentenvironmentofsystems-basedfoodsafetycontrolsthatprovideflexibilitywiththeselectionofcontrolmeasures,validationofthesecontrolmeasuresacquiresincreasedimportance.Itisthroughthevalidationprocessthatonedemonstratesthattheselectedcontrolmeasuresareactuallycapable,onaconsistentbasis,ofachievingtheintendedlevelofhazardcontrol.Itisimportanttomakeacleardistinctionbetweentheroleofindustry1andtheroleofthecompetentauthorityinvalidatingcontrolmeasures.Industryisresponsibleforvalidationofcontrolmeasures,whilethecompetentauthorityensuresthatindustryhaseffectivesystemsforvalidationandthatcontrolmeasuresareappropriatelyvalidated.Governmentsmayprovideguidancetoindustryonhowtoconductvalidationstudiesandhowvalidatedcontrolmeasuresmaybeimplemented.Governmentsorinternationalorganizationsmayalsoconductvalidationstudiesinsupportofriskmanagementdecisionsorprovideinformationoncontrolmeasuresconsideredtobevalidated,especiallywheretheresourcesarenotavailabletoconductsuchstudies(e.g.smallandless-developedbusinesses).Theseguidelinespresentinformationontheconceptandnatureofvalidation,taskspriortovalidation,thevalidationprocess,andtheneedforre-validation.Theseguidelinesalsoaddressthedifferencebetweenvalidation,monitoringandverification.AnnexIprovidesexamplesofvalidationscenarioswhichareforpurposeofillustrationonlyandwhichdonotrepresentactualvalidationofcontrolmeasuresandwhichdonothaveglobalapplication.II.SCOPETheseguidelinesapplytovalidationofcontrolmeasuresatanystageofthefoodchain2.Theseguidelinesareintendedasguidancetoindustryandgovernmentsonthevalidationofindividualcontrolmeasures,alimitedcombinationofcontrolmeasures,orsetsofcontrolmeasurecombinationsformingafoodsafetycontrolsystem(e.g.HACCP,GHP).Thetools,techniques,andstatisticalprinciplesthatwouldbeusedtovalidatespecificfoodsafetycontrolmeasuresarebeyondthescopeofthecurrentdocument.Adviceonspecificapplicationsshouldbeacquiredfromscientificorganizations,competentauthorities,processcontrolexpertsorrelatedsourcesofscientificexpertisethatcanprovidethespecificprinciplesandbestpracticesuponwhichthevalidationofaspecificcontrolmeasureshouldbebased.1Forthepurposesofthisdocument,itisunderstoodthatindustryincludesallrelevantsectorsassociatedwiththeproduction,storageandhandlingoffood,fromprimaryproductionthroughretailandfoodservicelevel(adaptedfromWorkingPrinciplesforRiskAnalysisforApplicationintheFrameworkofCodexAlimentariusandtakenfromPrinciplesandGuidelinesfortheConductofMicrobiologicalRiskManagement(CAC/GL63-2007).2Thefocusofthisdocumentisthevalidationofelementsofafoodsafetycontrolsystem;however,therecommendationsinthisdocumentalsomaybeappliedinthevalidationofotherfoodhygienemeasures.CAC/GL69-2008Page2of16III.DEFINITIONS3ControlMeasure:Anyactionandactivitythatcanbeusedtopreventoreliminateafoodsafetyhazardorreduceittoanacceptablelevel.4FoodSafetyControlSystem:Thecombinationofcontrolmeasuresthat,whentakenaswhole,ensuresthatfoodissafeforitsintendeduse.Monitoring:Theactofconductingaplannedsequenceofobservationsormeasurementsofcontrolparameterstoassesswhetheracontrolmeasureisundercontrol.5Validation:Obtainingevidencethatacontrolmeasureorcombinationofcontrolmeasures,ifproperlyimplemented,iscapableofcontrollingthehazardtoaspecifiedoutcome.6Verification:Theapplicationofmethods,procedures,testsandotherevaluations,inadditiontomonitoring,todeterminewhetheracontrolmeasureisorhasbeenoperatingasintended.7IV.CONCEPTANDNATUREOFVALIDATIONValidationfocusesonthecollectionandevaluationofscientific,technicalandobservationalinformationtodeterminewhethercontrolmeasuresarecapableofachievingtheirspecifiedpurposeintermsofhazardcontrol.Validationinvolvesmeasuringperformanceagainstadesiredfoodsafetyoutcomeortarget,inrespectofarequiredlevelofhazardcontrol.8Validationisperformedatthetimeacontrolmeasureorafoodsafetycontrolsystemisdesigned,orwhenchangesindicatetheneedforre-validation(seesectionVII).Validationofcontrolmeasuresis,wheneverpossible,performedbeforetheirfullimplementation.3Inmanycases,existingdefinitionssuchasthosecontainedintheSPSAgreement,theGeneralPrinciplesofFoodHygiene,HACCPAnnexandtheCCFHRiskManagementdocument,weresuitableforuseinthisdocument.Inothercases,whereadefinitionwastoolimitingoutsideofitsoriginalcontext(e.g.someHACCPAnnexdefinitions),anotherdefinitionwasdevelopedthatwasmoresuitableforusewithinthecontextoftheseguidelines.4InternationalRecommendedCodeofPractice-GeneralPrinciplesofFoodHygiene(CAC/RCP1-1969),HACCPAnnex.5DerivedfromRecommendedInternationalCodeofPractice-GeneralPrinciplesofFoodHygiene(CAC/RCP1-1969),HACCPAnnex,butwasmodifiedtoapplytoallcontrolmeasures,whetherornotaHACCPsystemisemployed.6Ibid.7Ibid.8SeePrinciplesandGuidelinesfortheConductofMicrobiologicalRiskManagement(CAC/GL63-2007)andPrinciplesfortheEstablishme