建立有效的食品安全风险因素的监测体系

BuildingtheInfrastructureforEffectiveMonitoringofFoodSafetyRiskFactorsPresentedby:DouglasL.Marshall,Ph.D.ChiefScientificOfficerEurofinsMicrobiologyLaboratoriesInc.ChinaInternationalFoodSafetyandQualityConference&ExpoShanghai,ChinaNovember8,2012Eurofins’MissionisHealthandSafetyFood#1worldwideEnvironment#1worldwidePharmaceuticalsTop10worldwideOurMission:Tocontributetoglobalhealthandsafetybyprovidingourcustomerswithhigh-qualitylaboratoryandadvisoryserviceswhilecreatingopportunitiesforouremployeesandgeneratingsustainableshareholdervalue2CompanyOverview•TheEurofinsGroupisthegloballeaderinthebioanalyticaltestingmarket(revenuesoverUS$1billion;12,000employees)•Over170laboratoriesin33countriesinEurope,AmericaandAsia•Greaterthan100,000differentanalyticalmethods•Indepthindustryexpertiseintechnical®ulatorymatters•Focusontheprotectionofourcustomers’products&valuablebrands•InvestmentsinR&Dandstate-of-the-artequipment•Rapidreactioncapabilitiesandlargecapacity34:22/06/2009TraditionalTestingSchemesvs.ManagementFocusTraditionalTestingSchemesContaminants(e.g.Pesticides,Mycotoxins,GMO,Dioxins,Vet.-residues)NutritionalAnalysesMicrobiologicalAnalysesToday’sManagementFocusRiskManagementBrandProtectionRoutineAnalysisValueAddedComponents5OldSchoolPillarsofFoodSafety•GoodManufacturingPractices(GMPs)•SanitationStandardOperatingProcedures(SSOPs)•HazardAnalysisCriticalControlPointProgram(HACCP)6NewSchoolPillarsofFoodSafety•EnvironmentalMonitoringProgram(EMP)–pathogens&allergens•SupplierVerificationPrograms–don’tinherityoursuppliersproblems•Audits–naivetyinuse7AdditionalPreventiveControlPrograms•Trainingprogramsformanagersand/orworkers•Auditprograms•Writtenrecords,e.g.,batchrecords,sanitationrecords•Validationofcontrolmeasures•Foodlabelreviewandcontrolprogram•Testingofin-comingrawmaterials,in-processmaterials,finishedproducts,andprocessingenvironment8CostofNotTesting•Potentialforinjuringorkillingyourcustomer•Intrinsicandextrinsiccostsassociatedwithrecalls•Damagedbrandreputation•Noliabilityprotection–doesliabilityincreaseduetolackofprudence?9WhatIsAThirdPartyLaboratory“Ifthelaboratorywishestoberecognizsedasathirdpartylaboratory,itshouldbeabletodemonstratethatitisimpartialandthatitspersonnelarefreefromanyunduecommercial,financialandotherpressureswhichmightinfluencetheirtechnicaljudgment”“Organisationsexternaltothelaboratorycannotinfluencetheresultsoftestscarriedout”FromENISO/IEC1702510WhatIsAThirdPartyLaboratoryTobeatruethirdpartylaboratory,therearetwoessentials:IndependenceImpartialityIndependence+Impartiality=Credibility11Retail&DistributionComprehensiveScopeofFood&FeedTestingAgriculturalproduction,productdevelopmentProductionOrganicResiduesMicrobiologySensoryAuthenticityPesticidesDioxinsVeterinaryDrugResiduesPopsHeavyMetalsIrradiationVitaminsQualityControlLabelingGMONutritionalSeedTestingMycotoxinsAllergens12Eurofins’CompetenceCentersDepthofKnow-how&ServiceofferTypicalLaboratoriesEurofins-NetworkofCompetenceCenters(CC)EurofinsoffersroutineanalysisaswellasmanyspecialistservicesthroughitsnetworkofCompetenceCentersSpecialistinoneareaXYGeneralistBreadthofserviceSpecialistinmanyareas‘Multi-Specialist’BreadthofservicesRoutineAnalysisSpecialistGeneralistDepthofKnow-how&ServiceofferBreadthofservice13TestingTrendsTheGood•LabAccreditation–insourceoroutsourcelabperformanceandqualityexpectations•Moreemphasisoncontrollinghazardsatreceivingstepsupplierverificationtesting•Moreemphasisonvalidatingcontrolprograms•Moreemphasisonenvironmentalmonitoringtesting•Newdetectionplatformsandmethods•Strainsourcetracking•Electronicdataaccessandmanagementtools14TestingTrendsTheBad•Reducedemphasisonendproducttesting•Lackofretailerinterestintestingweaklink!•Lackofimporter,processor&distributorunderstandingoftestmethodsandabilitytointerpretresults•Overrelianceonauditingforpurchasedecisions•Lackofwell-trainedtechniciansintheindustry•Academiccommunitydevelopinggoodbench-topmolecularbiologistswithlittlepracticalunderstandingoffoodprocessing15TestingTrendsTheUgly•Toomanylaboratoriesperformingteststheyknowlittleabout•Toomanyshortcutsbeingusedinlaboratoriestosavemoneyandincreaseprofits•ToomanycompaniescreatingfalseCOAs•Toomuchconflictofinterestwithinternallaboratoriesandsomegovernment-sponsoredlaboratories16BuildingaRobustAnalyticalServicesInfrastructure•Technicalexpertise•Technologyplatforms•Qualitycontrolprograms•Informationtechnology•Logistics•Customerservice17TechnicalExpertise•Doyourlaboratorymanagerspossessacademicdegreesappropriatetomanagementresponsibility?-Chemistsrunningchemistrydepartments-Microbiologistsrunningmicrodepartments•Doyourbenchtoptechnicianshaveacademictrainingappropriateforjobtasks?-Mathskillstododilutionproblems,analytequantifications,resultsinterpretation-Testplatformoperationalknowledge•Doyouhaveregulartrainingprogramsforalllaboratorystaff?18TechnologyPlatforms(kits&instruments)•Istheplatformvalidatedformatrixandanalyte?•Areyoureallymeasuringtheanalyteofinterest?•