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 broderick@wmep.org

PegDorn,FoodSafetyConsultant920.850.6590 dorn@wmep.org

LindseyTrickey,FoodSafetyConsultant920.277.4861trickey@wmep.org