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FOODSAFETYCULTUREANDCOMPETENCIES
PEGDORN,WMEP
LINDSEYTRICKEY,WMEP
WhatisaFOODSAFETYCULTURE?§Anawarenessofthehazardsandrisksassociatedwithmanufacturingaproductforhumanconsumption.Wouldyoueatthis?
§FoodSafetyisrecognizedasacorevaluebybothmanagementandemployees.
§PartofManagementResponsibility
StrongFoodSafetyCulturevsWeakFoodSafetyCultureSTRONG
Foodsafetyexpectationsandvaluesclearlycommunicated.
Standardoperatingproceduresareclearlycommunicatedandfollowed.
WEAK
Corevaluesarenotwellestablishedanddonotincludefoodsafety.
Tribalknowledgeisthenorm.
BenefitsofaFoodSafetyCultureBrandProtection
Consistentoutput
Pro-activevsReactiveatmosphere◦ Nolongerputtingoutfiresconstantly◦ Owners,Managers,andDirectorscanconcentrateonstrategicvisioninsteadofday-to-daycrises
HowtoAttainaFoodSafetyCultureItstartswithMANAGEMENTCOMMITMENTManagementmustleadbyexample◦ Followallfoodsafetyregulations◦ Training◦ Establishafoodsafetycompanypolicy◦ Setgoalsandcelebratesuccesses
Competencies– WhatDoesitTaketoHaveaStrongFoodSafetyCulture?
ManagementCommitment◦ Managementmustbededicatedtofoodsafety.
FoodSafetyTeam◦ Acrossfunctionalteamtaskedwithriskanalysisandpreventivecontrols.◦ ThisistypicallytheHACCPteam.
StrongFoodSafetyTeamLeader◦ Backgroundoreducationinfoodsafety◦ Authoritytomakedecisionsandimplementprograms
KnowledgeableEmployeeso Employeesmustunderstandtheirroleinfoodsafety
HowdoIgetstarted?Don’tre-inventthewheel◦ GFSIandFSMAhaveprovidedguidelinestocreatingandmaintainingtheproperculture.◦ TheGlobalFoodSafetyInitiative(GFSI)◦ Foodsafetymanagementprogramsgloballyapprovedandproventobeeffective.◦ CertificationProgram◦ Multipleoptions(SQF,BRC,FSSC22000)– Choosetheonebestsuitedforyou.
◦ FoodSafetyModernizationAct(FSMA)◦ FDArequirementsforfoodmanufacturers.◦ Includepreventivecontrols,recallprocedures,andallergenawareness.
HazardAnalysisCriticalControlPoint(HACCP)RiskBasedApproachtofoodsafety
• Assesshazardsassociatedwithingredientsandprocesses
• Identifypointsintheprocesswherehazardscanbemitigated(controlpoints)
• Definelimitsforthosecontrolpointsandmonitorthem
• Identifycorrectiveactionsifsomethinggoeswrong
• DOCUMENT,DOCUMENT,DOCUMENT
• Validateandverify
Pre-requisiteProgramsDocumentedProceduresfor:• Building,Premise,Equipment,andWarehousing• UtilitiesandWasteDisposal• PurchasedMaterial• Crosscontamination• SanitationandPestControl• PersonnelhygieneandGMPs• Rework• FoodDefense
ManagementSystemsBepreparedwithdocumentedproceduresfor:◦ EmergencyPreparedness◦ BusinessContinuity◦ Recall◦ ProductDevelopment◦ VendorControl◦ Holdandrelease◦ EnvironmentalMonitoring◦ PreventiveMaintenance◦ DocumentControl
TrainingEmployeesmusthavetrainingon:
◦ FoodSafetyPolicyStatement(ManagementCommitment)◦ HACCP◦ PersonalHygieneandGMPs◦ Sanitation◦ Allergens◦ FoodDefense
BasicGoodManufacturingPracticesforFood
DevelopmentofFoodGMP1906PureFoodandDrugsAct
1933OverhaulAct
1938Food,Drug&CosmeticAct◦ Insanitaryconditionssufficienttoproveadulterated◦ Section402(a)(3)specifiesthatfoodhasbeenmanufacturedundersuchconditionsthatitisunfitforconsumption.◦ Section402(a)(4)considersthatfoodmaybeadulteratedifitisprepared,packed,orheldunderinsanitaryconditionswhereby itmayhavebecomecontaminatedwithfilthorrenderedinjurioustohealth.
ImplementationofGMPs21CFRPart117(originallypart128until1969)◦ 21CFR106NutrientsforInfantFormula◦ 21CFR113Thermalprocesslow-acidcanning◦ 21CFR114AcidifiedFoods◦ 21CFR129BottledDrinkingWater
GMPGeneralProvisions(subpartA)
BuildingsandFacilities(subpartB)
Equipment(subpartC)
ProductionandProcessControl(subpartE)
DefectActionLevels(subpartG)
GeneralProvisions(A)Sections◦ Terminology“shall”vs.“should”◦ Personnel◦ Hygiene/Cleanliness,Clothing,Jewelry,GloveMaintenance,HairRestraints,Personnelitemstore,Eating/Drinking
◦ Education/Training◦ Supervisorypersonnelensurecompliance
◦ ExemptionstosectionA◦ harvest,storeordistributerawagriculturalcommodities
BuildingsandFacilities(B)MaintenanceandGrounds
SanitaryOperations
SanitaryFacilities/Control
Requirementsrangefromspecifictogeneral
Equipment(C)Design
Construction
MaintenanceofEquipment
MaintenanceofUtensils
Automatictemperaturecontrolregulationw/Alarm
ProductionandProcessControls(E)GeneralSanitationProcess/Controls
MonitoringofPhysicalFactors◦ CriticalControlPoints(time,temp,humidity,pH,flowrateandacidification)
WarehousingandDistribution◦ Conditionstoprevent
Dependsontheriskoftheproduct
DefectActionLevels(G)FilthandExtraneousMaterialsetbyFDA◦ Insects◦ Mold◦ Presenceofrodent
Mixingcontaminatedfoodwithsuitablebatchrendersbothbatchesasadulterated.
ElementsofaSuccessfulFoodSafetyManagementSystem
HACCPPlan
Pre-requisitePrograms◦ GMPs,PestControl,Etc.
PreventiveControls◦ AllergenControl,VendorControl,ProcessControl,SanitationControl
ManagementSystems◦ Training,Recall,BusinessContinuity,PreventiveMaintenance
MANAGEMENTCOMMITMENT
ResourcesHaveaconsultantperformagapanalysis◦ CheckwithyourStateManufacturingExtensionPartnership◦ Wisconsin– WMEP◦ Illinois– IMEC
◦ CertificationBodies◦ SGS
ContactInformationAndyBroderick,BusinessDevelopmentLeader608.630.4028 [email protected]
PegDorn,FoodSafetyConsultant920.850.6590 [email protected]
LindseyTrickey,[email protected]