HACCPPrinciples

1.
2.
3.
4.
5.
6.
7.

Principle6:
EstablishingVerificationProcedures

Chapter 13 Verification Procedures

HACCP A Systematic Approach to Food Safety

ConductaHazardAnalysis(HA)
IdentifyCriticalControlPoints(CCPs)
EstablishCriticalLimits(CLs)
EstablishCCPMonitoringRequirements
EstablishCorrectiveActions(CA)
EstablishVerificationProcedures
EstablishRecordKeepingProcedures

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HACCPPrinciple6:
EstablishVerificationProcedures

Validation
DefinitionofValidation Thatelementofverification
focusedoncollectingandevaluatingscientificand
technicalinformationtodetermineiftheHACCP
plan,whenproperlyimplemented,willeffectively
controlthehazards

DefinitionofVerification Thoseactivities,otherthan
monitoring,thatdeterminethevalidityoftheHACCP
planandthatthesystemisoperatingaccordingto
theplan

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VerificationandValidation

Verification
Dowedowhatwesayandsaywhatwedo?

Validation
Isittherightthingtodo?

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Validation
InitialValidation
Initialvalidationisconductedduringimplementationofthe
HACCPplan.
Includesareviewofthehazardanalysis
HACCPteamalsoreviewsCCPs,CLs,andmonitoring
Informationneededtovalidateincludes
Expertadvice
Scientificstudies
Inplantobservations

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Validation

Questionstoaskduringreassessment

Revalidation
Subsequentvalidationwhenchangesaremadeto
theprocessthatcouldimpacthazardanalysis
Annualreassessmentrequiredinseafood(21CFR
123)andmeatandpoultry(9CFR417)regulations
Asnewinformationbecomesavailable

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FSMAAnimalFeedValidation

II.

2.

Priortotheimplementationofthefoodsafetyplanor,when
necessary,duringthefirst6weeksofproductionand
Wheneverareanalysisofthefoodsafetyplanrevealstheneed
todoso.

Mustincludecollectingandevaluatingscientificand
technicalinformationtodeterminewhetherthepreventive
controls,whenproperlyimplemented,willeffectivelycontrol
thehazardsthatarereasonablylikelytooccur

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10

VerificationofCCPs Calibration

Involvesthedaytodaycomplianceoftheactivities
ateachCCPtodetermineiftheycomplywiththe
HACCPplan
VerificationactivitiesdevelopedbytheHACCPteam

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VerificationofPrerequisitePrograms
VerificationofCCPs
Calibration
Recordsreview
Independentcheck
VerificationofHACCPPlan

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VerificationofCCPs

Verification threeitems

Thevalidationofthepreventivecontrols:
1.
Mustbeperformedbyaqualifiedindividual:
I.

Arethereadditionalhazardsthatshouldbe
addressedintheHACCPplan?
Haveanychangesoccurredoristhereanynew
informationforthehazardanalysis?
AretheCCPsandcontrolmeasuresstill
appropriate?
AretheCLsadequatebasedoncurrent
information?
Aretheactivitiesineachsectionoftheplanstill
adequateandappropriateforidentifiedhazards?

11

HACCPplansrelyonaccuratemeasurements(e.g.
temperature,pressure,pH,flowrate,wateractivity)
Specifyinstrumentsorequipmentandtheir
calibrationfrequencyandindividualresponsiblein
theplan.
Goal,accuratemeasurements
Recordsforcalibrationactivities

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VerificationofCCPs CorrectiveAction
RecordsReview

VerificationofCCPs RecordsReview
Purposeofrecordreviewistoverifythat:
Recordswerepreparedcorrectly
Monitoringactivityandfrequencywere
performedasrequiredintheHACCPplan
Nomonitoringactivitiesweremissed
AllmonitoringresultswerewithintheCLsandany
deviationwasidentified

Purposeofcorrectiveactionrecordsreview
CArecordforeachdeviation
Documentationofthedeviation(magnitude)
Affectedproductwasidentifiedandisolated
CAwereconductedaccordingtotheHACCPplan
Finalproductdisposition
IndividualswhoperformedCAwereidentified
Alldecisionsjustified
Reportwaspreparedcorrectly
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IndependentCheck

MicrobialTestingtoVerifyCCPs

Independentchecksprovideasecondlevelof
assurancethattheCCPisprovidingadequate
controlofthehazardand/orthatthehazardis
beingcontrolledasintended.

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15

Usefulfor
periodicCCP
verification

Example
verifymicrobial
safetyof
ingredients

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HACCPPlanVerification

16

HACCPPlanVerification Records

Conductedperiodically
Recordreview
OnsiteAudit

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17

CurrentHACCPplan
Auditreportsofprerequisiteprograms
Product/processdescription,flowdiagram
Monitoring,CCPverification,calibrationandCA
records
PreviousHACCPauditreports

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HACCPPlanVerification
OnsiteAudit

FSMAAnimalFeedVerification
Theowner,operator,oragentinchargeofthefacilitymust
verifythat:
1.
Monitoringisconductedasrequired,
2.
Appropriatedecisionsaboutcorrectiveactionsarebeing
madeasrequired,
3.
Thepreventivecontrolsareconsistentlyimplementedand
areeffectivelyandsignificantlyminimizingorpreventingthe
hazardsthatarereasonablylikelytooccur,
4.
Theactivitiesconductedmustcalibrationofprocess
monitoringandverificationinstruments.

ConfirmoperationattheCCP
ConfirmoperatorsknowledgeofCCPsoperation,
theCLs,andthemonitoringandCArecord
keepingactivitiesrequiredbytheHACCPplan
Observetheoperatorperformmonitoring
Examineinprocessmonitoringrecords

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FSMAAnimalFeedVerification

20

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IdentifyingRecordkeepingandVerification
ProductCategory:CattleProtein/MineralMedicatedSupplement
Process
Step CCP

Verifythatthepreventivecontrolsareconsistently
implementedandareeffectivelyandsignificantlyminimizing
orpreventingthehazard
Establishandimplementwrittenprocedures,asappropriate
tothefacilityandtheanimalfood,forthefrequencyof
calibratingprocessmonitoringandverificationinstruments
Conductareanalysisforthefoodsafetyplanatleastone
every3years,orwheneverasignificantchangeismade,or
newinformationismadeavailableaboutahazard,or
wheneverapreventivecontrolisnotproperlyimplemented
orfoundtobeineffective,orwheneverFDArequires
reanalysis.
Allverificationactivitiesmustbedocumented

Bulk
Receiving

Record

Responsibility

CCP Verification

Short Term
Daily review of receiving log
and paperwork by QA/QC
department

Long Term
Operational audit performed
by designated management
personnel to make sure
Receiving Bulk Ingredients
SOP is followed

Approved:____________________________ Date:_______________
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Hazard

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22

END

Dr. Tim Herrman

Professor, State Chemist & Director
Office of the State Chemist
Texas A&M University
(979) 845-1121
tjh@otsc.tamu.edu

OFFICE OF THE TEXAS STATE CHEMIST

Texas Feed and Fertilizer Control Service

Agriculture Analytical Service