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Page1

Qualitysystem

foodsafety

Inordertoensure(HACCP)and

Accreditationoflaboratories

MICRO575Food
andenvironmentalhygiene,and
surveillance

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Guidelinesandlegislation

CodexAlimentarius,theInternationalFoodStandards/
internationalfoodstandards
EClegislation,inparticularthehygieneoffoodstuffsEC
852/2004,ArticleAnalysisandCriticalControl5Risk
ControlPoints
Nationallegislation
GeneralFoodHygieneRegulationEC852/2004AnnexII:All
hygienerequirementsapplicabletofoodbusinessoperators
thatyouhavereceivedthisAnnex,theRegulation!
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See.Contents.
ClaimsMAFDcr37/EEO/2006foodstuffsofanimalorigin
thehygieneoffoodstuffs,inparticular,annexes15
MAFDcr28/2009ofcertainfoodestablishments
thehygieneoffoodstuffs
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HACCPguidelines

CodexAlimentarius

EuropeanCommission:Guidancedocument.HACCP
theimplementationofproceduresbasedontheprinciplesof
andfacilitatingtheimplementationofHACCPprinciples
incertainfoodbusinesses
http://ec.europa.eu/food/food/biosafety/hygienielegislation
/guidance_doc_haccp_fi.pdf

TheHACCPsystem,principlesandapplication(Evira's
Help10002/1)
Www.evira.fi

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HACCPguidelines

FoodAssociationHACCPbased
selfregulatinginstructions
Www.etl.fi
Ageneralpart
Fishingindustry
Vegetablesandberries,industrial
BakeryIndustry
Meatandconveniencefoodindustry
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MilkProcessingIndustry
Confectioneryindustry
Magazinearticles
FoodandHealth
Developingfood

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Danger=thefoodofthebiological,
physicalorchemicalfactorthatmay

jeopardizethesafetyofthefood

Risk=Hazardtohealthcausedby

theadverseimpactofthelikelihoodand
strength

(EPNAs178/2002Article3)

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Scientificriskassessment

Riskassessment(inenglish.Riskassesment)

meansaninternationalscientificwork

EFSA(EuropeanFoodSafetyAuthority)

thescientificriskassessmentsandstatements
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Thedevelopmentoflegislation

Nationalscientificriskassessments

nationallegislation,programsandguidelines

Someoftheriskanalysis(seefollowingfigure).

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Riskanalysis
(CACCodexAlimentarius
Comission)

Source:Maijala,R.2007workKorkealaFoodHygiene(ed.)

Riskassessment:
Hazardidentification
Hazardcharacterization
Exposureassessment

R
hit

Riskcharacterization

message

onColorado

Riskmanagement:
OverallRiskAssessment
Evaluationofoptions
Applicationoptions
Monitoringand
Reassessment

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!Practicalriskassessment!

Inhousecontrolplanningrequiresreliable
andsystematicinformationonthefoodbusinessoperator
thedangersofariskassessmentoftheproduction

Productionfacilities
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Identifythehazards
Assesstherisksinvolved,and
Beabletochoosetherightriskmanagementmeasures.

RegionalStateAdministrativeAgenciesandmunicipal
controlplansarebasedmostly
practicalriskassessmentcontrol
targeting,forecastingandresource
contingencysituations
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Themostsignificantfoodpoisoning

Inrecentyears,causesof

2004

1.Tooslowcooking
cooling

2.Insufficient
heatingfood

3.Invalid
storagetemperature

2005

2006

Infected

Incorrect

employee

storagetemperature

Incorrect

Inadequate

storagetemperature

cooling

Contaminatedraw

Inadequate

substance

heating

Source:FoodpoisoningsinFinlandreports,Evira

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Selfcontrolandriskmanagement

Thelegislation
basedon
selfcontrol
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Selfassessmentplan
GHPGoodHygienic
PracticesLadies
hygienepractices
GMPGood
ManufacturingPractices
Goodproductionpractices
HACCPHazard
AnalysisandCritical
ControlPoint

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Foodsafetyand

Qualitysystems

QualityManagement,TQM

GMP,GHP,ieGood

HACCP

Productionand
hygienepractices

Qualitymanagementsystem,forexample.ISO9000,
ISO22000

SupportPrograms
PRSPs,

Selfassessmentplan

selfmonitoring
foundation

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HACCPsystemand

prerequirements(supportprograms)

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Foodhygienerequiresthat
foodbusinessestoimplementHACCP
prerequisiterequirementsandbasedontheprinciples
procedures
Em.Thepurposeoftherequirementsisthegeneralrisks
control

HACCP

Theaidscheme,or
prerequisites:
Staff
training

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Ownchecks/

supportsystem

Prerequisiteprograms,PRSPs

alloftheHACCPsystemprerequisite
Thesystemsandrulesthataimat
foodsafety

supportsystemconsistsoffoodhygiene
thegeneralprinciples(GeneralPrinciplesofFood
Hygiene)basedprograms
Ks.HACCPsystem,principlesandapplication
(Evira'sinstruction10002/1)p.67

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Prerequisites

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Infrastructureandequipmentrequirements
Requirementsfortherawmaterials
Safehandlingoffood(packagingand
transportationincluded)
FoodProcessing
Tuholaistorjuntamenettely
Sanitationprocedures(cleaninganddisinfection)
WaterQuality
Maintainingthecoldchain
EmployeeHealth
Personalhygiene
Education

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HACCPprinciple

HAzardAnalysisCriticalControlPoints
Theobjectiveofmanufacturingandprocessingoffood
potentialmicrobiological,chemicalandrelated
Preventionofphysicalrisks
applicablethroughoutthefoodprocessingchain
Primaryproductionoffood,industrialmanufacturing,transportation,
storage,marketing,cateringandlargeeconomiesEVENT
cooking
HazardAnalysisassessmentofrisk,ietheriskof
CriticalControlPointscritical,oressential
managementofcredit
Suchworkingorprocessingstage,wheretheriskcanbeseenandits
progressioncanbehaltedandtowhichmanagementmeasurescanbe
target
Ofvitalimportanceoffoodsafetythreat,
inordertoprevent,eliminateorreducetoanacceptable
level
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HACCPprocedures

Requiresawiderangeofexpertisetobeconsidered
rawmaterials,manufacturedproducts,
theproductionprocess,distributionchain,maintenanceand
sanitation,qualitycontroland
thehygieneoffoodstuffs(microbiological,chemicaland
physicalhazardsandtheirmanagement)
HACCPgroup,whichmayalsobeused,ifnecessary,
externalexpertise
Mayalsobe,forexample,subgroupsofproductsHACCP.
TheHACCPsystemfunctionalityrequirescommitmentand
trainingintheprinciplesofthesystem(trainingwillbe
recorded)

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ProductDescriptions

Product...
ProductName
Features
Preparationandadditives
Thecharacteristicsandoriginoftherawmaterial
Manufacturingmethod
TypeofpackagingandSupplies
Labeling
Shelflife
Storage
Distribution
anditsuseofthedescription
Ausergroup(generalconsumption,orsomespecificgroup)
Operatingmode

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Flowcharts

Productorgroupofproductsprocessingand
thepreparationstagesofthework
inchronologicalorderofrawmaterials
thereceptionofthepackinganddistribution

ProductSafetyrelevantdata
Temperatures,thedurationofthestagesofproductionandresidence

Transferstoanotherroomspace

Possibleproductretreatment

(Ifnecessary,theroomofthehygienelevel)

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HACCPsevenprinciples

1.

Riskassessment

2.

Determinationofcriticalcontrolpoints

3.

Determinationofcriticallimits

4.

CCPmonitoringpractices
compilation

5.

Determinationofremedialmeasures

6.

EstablishmentofverificationprocessandHACCPprogram
Validation

7.

HACCPdocumentsandrecords

Theprinciples2to5aremanagedbyidentifiedhazards!

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Riskassessment

Identifyhazardsthatmustbeprevented,

a)

eliminatedorreducedtoanacceptablelevel
(EPNAs852/2004of5art.)
Flowchartsandproductdescriptionsunderlying
Hazardsidentification
Allmanufacturingandproductadditives,
inpackaging,laborandproductionphases,
storageanddistributionofmedicinesbiological,
chemicalandphysicalhazards
Takesintoaccountusergroups
Makinguseofresearchdata,information
foodpoisoning,controldata

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Riskassessment

Riskassessmentoftheprobabilityandseverityof
Useoffoodproductsandtheirrawmaterialsrelatedto
epidemiologicalstatistics,theresultsofthenationalcontrolprograms
andscientificpublications,informationonselfevaluation,
customercomplaints
Seriousnessreferstothehealthriskposedbyaparticularhazard
degrees(thefocushereisspecificallydetrimentalhealtheffects,noother
qualitydefects)
Basedontheseverityandtheprobabilityofdecidingwhether
identifiedariskofsignificant
Controlofmeansofidentification
Identifythemeansbywhichsignificantriskscanbemanaged,ie
toprevent,eliminateorreducetoanacceptablelevel
Forexample,heating,cooling,decreaseinpH,ortherawmaterial.
Requirementsprocurementrequirements
Hazardscanalsobemanagedusingthesystemofaidprograms
(eg.,hygienicworkingmethods,productionspacetemperaturecontrol,
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labeling)

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Microbiologicalhazards

Themicrobescancause
Foodcontamination
Foodpoisoning(intoxication,infetktiot)
ProcessProblems

Pollution,iecontamination
Crosscontamination
Introducingsecondary

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ChemicalRisks

Thefoodnaturaltoxins
Thepreparationoffoodprocessingborn
toxins,forexample.PAH
Mycotoxins,iemycotoxins(canalsobe
Themicrobiologicalrisk)
Thepreparationoffoodprocessingborn
toxins,forexample.PAH
Additivestoomuchinmetered
EnvironmentalToxins
Pesticideresidues
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Residuesofveterinarymedicinal
Transferredtothefoodpackagechemicals

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Physicalhazards

Cancontaminatethefoodmechanically

Foodstuffsappeartothenakedeye
seeninforeignobjects
Dust,dirt,mud,mold
Thestones,buttons,nails,woodandmetalpiecesetc.
Hair,plasters,cigarettebutts,etc.
Deadinsects,otherpestsaswellastheir
droppings
Equipmentusedinthemanufactureoffood
detachedparts,fragmentsetc.ofthepackagingmaterial.
Othernonfooditems

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Criticalcontrolpoints(critical

ControlPointCCP)Setting

b)

identifythecriticalcontrolpointsatthestepor
stages,whichcontrolisessentialhazard
combat,eliminateorreduceitto
toanacceptablelevel(EPNAs852:2004art.5)
Thestartingpointisalwaysahealthrisk,noproduct
Qualityfeatures
Theriskcanbedetectedbymeasuringorestimating
Theriskcanbecontrolled

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Hallssatisfyingaboutittodeterminethecriticallimits
Thecriticallimitisexceeded,thesafetycanbeguaranteed
correctivemeasures

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CriticalControlPoint(CriticalControl

PointCCP)

TheMinistryofEmploymentandtheproductionphase,inwhichfoodsecurity
controlledbymeansofanaidscheme,shouldnotbeselectedasacritical
managementpoint
TheCCPmaybe
Theheatingoftheproduct,whereinthemicrobialpestsharmfulto
Coolingandfreezingstepinwhichmicrobialgrowthisprevented
Productionphasewherethesafetyoftheproductoftheactive
thecompositioniscontrolled(pH,a

Productionphase,usingametaldetectoror
fluoroscopy
CCPcanbeusedtodeterminethe
decisionmakingtree(SancoandtheCodexAlimentarius)

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Determinationofcriticallimits

c)

Definethefightagainsttheidentifiedrisks,
eliminationorreductionofcritical
criticallimitsatcontrolpointsacceptable
leveltoseparatelevels,whichcannotbe
approve

(EPNAs852:2004art.5)

Theminimumandmaximumvalues
withinwhichcritical

Controlpointsofthehealthhazardsremainwell
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controlledorpreventedaltogether
Justifiedandmeasurable

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Determinationofcriticallimits

Maybebasedonlegislation,regulatoryguidance,
literature,food,andthetestreports
expertsviews
Criticallimitscanbesettoatemperatureperiod,
watercontent,wateractivities,pH,
salinity,preservatives,andthenumberof
Sensorycharacteristics
Thealarmlimittheupperorlowerthanthecriticallimit,
acrossing/undercuttingsuggeststhat
approachedthecriticallimit

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Establishmentofmonitoringpractices

Establisheffectivecriticalcontrolpoints

d)

proceduresformonitoringandimplementing
(EPNAs852:2004art.5)
EachCCPwillbemonitoredasplanned
Monitoringpracticesaredescribed

Whatwillbemonitored

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MonitoringMethod

MonitoringFrequency

monitoringsupplier

towhombenotifiedifadiscrepancyiscriticallimitsor
anyalarmlimits

howtofollowuparerecorded
NecessaryfollowupformsorthesystemCCP
automaticmonitoring

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Establishmentofmonitoringpractices

TrackingMethod
Theresultsshouldbemade
quickly,inordertoappropriatecorrectivemeasures,

totakeimmediate
Inmostcaseschemicalandphysicalmeasurements(pH,
temperatureandtimemeasurements,theuseofametaldetector,fluoroscopy)
Sensoryevaluation
Microbiologicalandchemicalanalyzesforthispurposeisoftentooslow
Monitoringfrequency
SufficienttoestablishthebasisofwhetherthemanagementoftheCCPornot
Executionandfollowupmeasures
Record:date,time,productidentification,monitoringresults
Inthemanualfollowupverificationofthemonitoringprovider
Monogrammed/signature
Automaticfollowupmonitoringtocheckonaregularbasis(eg.
daily,batchbybatch)recordedtheresultsandrecordsoftheautomaticequipment
thedateoftheinspectionandinitials/signature
Thedeviationsareclearlymarked
Deviationsindicatethepersonwhoisresponsibleforthecorrectivemeasures
theexecutionof
Conductsthemonitoringrecordstheiractions

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Determinationofremedialmeasures

e)

Establishcorrectiveactionswhenmonitoring
indicatesthatacriticalcontrolpointisnot
undercontrol

(EPNAs852:2004art.5)

themonitoringofthesupplierdetectsadiscrepancyofthecritical
limitsorpossiblealarmlimitsshouldtake

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correctivemeasures
Remedialmeasuresshallbedeterminedforallcritical
allcriticalcontrolpointsatthebordersand
potentialalarmlimits
Bedesignatedasthesupplieroftheremedialmeasuresdescribed
Recognitionanddevelopingmeasuresused
Forms
Forexample,thetemperaturecorrectionofpH.Adjusters,
additionalcleaningmeasures,thefunctioningofequipmentmaintenanceand
correctionsintheproductionprocess
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Correctivemeasuresshouldbe

comprises:

Themeasuresrelevanttotheproductthatare

1.

dependingonthecase:
a)thecontinuationofprocessing(eg.thedirectheating,
Continuation)
b)theproductlotofuseof(oftenthefirst
measure)
c)investigationofthehygienicqualityofthebatch(forallother
asthecasesofaparagraph)
d)Retraction(Ifaconsignmentofproductsalreadyonthemarket,thisisanindication
thefactthattheHACCPsystemhasbeenbetrayed)
e)Theproductreprocessingevenwhentheproductisstill
foodpremises
2.

Correctingthedeviationsothatacriticalcontrolpoint
willagaincontrol

3.

Thedeviationdetectionandeliminationofthecause

4.

Preventionofarecurrenceofthedeviation

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Preparationandverificationprocess

HACCPplanvalidation

f)

Establishingprocedures,whichshalltake
atregularintervals,aesubparagraph
theeffectivenessofthemeasuresreferredto

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revision

(EPNAs852:2004art.5)

,VerificationensurestheHACCP
effectivenessandadequacyofthesystem

Monitoringandrecordsarisingfromtheremedialmeasures
andsummariesofinspection

Monitoringandcorrectivemeasuresforpersonsperforming
Auditactivities

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Preparationandverificationprocess

HACCPplanvalidation

Thefunctioningofmeasurementinstrumentsusedininspection

Potentialmeasurementsmade
bytheverifierhimself

Samplingproducts(microbiological,chemicaland
physicalexaminations)orsensoryevaluation
Authenticationisdoneonaregularbasistheagreedschedule
inaccordancewith
Theverificationshallbecarriedouttoadifferentpersonthanthefollowup
Verificationisdocumented

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HACCPplanvalidation

IstheHACCPprogramdrawnupcorrectly?
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Cantheimplementationofaprogramtoensuretheproduct
thesecurityorwhethertheprogramneedtochange?
AlkuvalidointibeforetheintroductionoftheHACCPprogram
Thereassessmentannuallyor
Youchangetheprocess,therawmaterialsorproduct
Newinformationonpossiblehealthhazards
Thisproductcanbefoundpathogens
Theproductshavecausedfoodpoisoning
Thecriticallimitsareexceededrepeatedly
Validationisdoneinadocumented

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HACCPdocumentsandrecords,aswellas

theirmanagement

g)

Elaboratefoodcompanysizeandnature
inaccordancewiththedocumentsandrecordsofthe
demonstratethatreferredtoinsubparagraphf
measuresareeffectivelyapplied
HACCPdocumentsincludeplansandinstructions,
arisingfromtheHACCPsystempreparation
andtoguidetheimplementationofthesystem
HACCPrecordsareentriesandinformation,which
bornoftheimplementationoftheHACCPprogram

Mustbeidentifiableandtraceable,andmade
sothattheyarenot

canchange

HACCPrecordsarekeptfortwoyears,and
atleast6monthsthantheproductofthesalesperiod

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EL23/200620

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"Inhousecontrolshouldbeaccompanied,ifnecessary

samplingandanalysisplanaswellas
Datalaboratories,whereselfmonitoring
Samplestobeanalyzed."

inparticular,arerequiredbylaw

omavalvontatutkimuksetismade

approvedlaboratory

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Classificationoflaboratories

RegulatoryLaboratories
Accredited

Omavalvontanlaboratoriot
Theexaminationsprovidedforlegalacts

Othersupervisoryauthorityordered

studies(VnA321/2006)
EstimatedforapprovalbyEvira,theassessment

takeFINASAccreditation

MeatInspectionBodies

VnAlaboratories
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EL23/200620
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"Inhousecontrolshouldbeaccompanied,ifnecessary

samplingandanalysisplanaswellas
Datalaboratories,whereselfmonitoring
Samplestobeanalyzed."

inparticular,arerequiredbylaw

omavalvontatutkimuksetismade

approvedlaboratory

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Classificationoflaboratories

RegulatoryLaboratories
Accredited

Omavalvontanlaboratoriot
Theexaminationsprovidedforlegalacts

Othersupervisoryauthorityordered

studies(VnA321/2006)
Estimated

MeatInspectionBodies

ComingVnAlaboratories

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Accreditation

TestingandcalibrationlaboratoriesGeneral
ontherequirementsofthestandardSFSENISO/IEC
17025:2005
MIKESCentreforMetrologyandAccreditation/FINAS
Accreditation
Akkreditointikausi4years
Every4thyearreaccreditation
Theintervals,asarule,periodicassessmentseveryyear
LeadAuditorFINASista
TechnicalReviewerstendtootherlaboratories
AccreditedPtevyysalueessamethods

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