fami qs v5 codeofpractice

FAMIQSCodeofPractice

EuropeanCodeofPracticefor

FeedAdditiveandPremixtureOperators

1 IntroductionThisEuropeanCodeofPracticeforAnimalFeedAdditiveandPremixtureOperators(Code)isinlinewiththeRegulationof theEuropeanParliamentand theCouncil layingdown requirements for feedhygiene,(183/2005/EC),inparticulararticles20to22whichencouragethedevelopmentofguidestogoodpracticeonhygieneandtheapplicationofHACCPprinciples.

Implementation of the Code aims to encouragemeasures to be put in place to ensure the safety andqualityoffeedadditivesandpremixtures;theoperationofbusinesses inaccordancewithEuropeanfeedhygienerequirements,andimprovedtraceability.TheCodeappliesequallytoimportfromthirdcountriesoffeedadditivesandpremixtures.

InordertoaligntheCodewithcurrentanimalfeedlegislationandvariousactivitiesonnational,industrialand/or association levels, it takes into account theprinciplesof feed and food safety aswell asHACCPprinciplesthataresetoutinvariousinternationaldocumentsfurtherdownandEClegislation,inparticular:

TheEuropeanCommissionsWhitePaperonFoodSafety(COM(1999)719final)http://europa.eu.int/comm/dgs/health_consumer/library/pub/pub06_en.pdf

Regulation (EC)No183/2005of theEuropeanParliamentandof theCouncilof12 January2005laying down requirements for feed hygiene (and repealing Council Directive 95/69/EEC andCommission Directive 98/51/EEC (apart from article 6 on Interim measures), laying downconditionsandarrangements forapprovingand registeringestablishmentsand intermediaries intheanimalfeedsector).(Regulation(EC)No183/2005)

http://eurlex.europa.eu/LexUriServ/site/en/oj/2005/l_035/l_03520050208en00010022.pdf

Regulation(EC)No1831/2003oftheEuropeanParliamentandoftheCouncilonadditivesforuseinanimalnutrition.(Regulation(EC)No1831/2003).

http://europa.eu.int/eurlex/pri/en/oj/dat/2003/l_268/l_26820031018en00290043.pdf

Regulation (EC)No178/2002of theEuropeanParliamentandof theCouncilof28 January2002layingdownthegeneralprinciplesandrequirementsoffood law,establishingtheEuropeanFoodSafetyAuthority.(Regulation(EC)No178/2002).

http://europa.eu.int/eurlex/pri/en/oj/dat/2002/l_031/l_03120020201en00010024.pdf

Regulation (EC)No882/2004of theEuropeanParliamentandof theCouncilof29April2004onofficialcontrolsperformedtoensuretheverificationofcompliancewithfeedandfoodlaw,animalhealthandanimalwelfarerules.(Regulation(EC)No882/2004)

http://eurlex.europa.eu/LexUriServ/site/en/oj/2004/l_191/l_19120040528en00010052.pdf

Otherdocuments:

TherelevantCodesofpracticeoftheCodexAlimentarius.http://www.Codexalimentarius.net/

Version5,1April2009

Page1/39


TheprinciplesofHACCP,re.CodexAlimentarius,GeneralprinciplesofFoodHygiene,(CAC/RCP11969, Rev. 42003Amd. (1999),Annex onHazardAnalysis and Critical Control Point (HACCP)SystemandGuidelinesforitsApplication)

http://www.Codexalimentarius.net/

Management systemsdevelopedbyassociations indifferentMemberStates, forexample,otherCodesofPracticeandQualityAssuranceSchemes:

CodeofPractice(FEFAC,EU)

http://www.fefac.org/Code.aspx?EntryID=265

FEMAS(AIC,UK)

http://www.agindustries.org.uk/content.template/30/30/Home/Home/Home.mspx

GMP(OVOCOM,B)

http://www.ovocom.be/

GMP+(PDV,Nl)

http://www.pdv.nl/index_eng.php?switch=1

Q+S(DVT,D).

http://www.qs.info/

Thecombinationoftheaboveprinciplesprovidesguidanceforfeedadditiveandpremixtureoperators inimplementingthemeasuresnecessarytoensurefeedsafetyinEuropeanand internationalmanufacturingand trade. In order to facilitate implementation of the Code, the structure of ISO 9001:2000, QualityManagementSystems,isused.

In theexceptionalcasewhereadirector indirect risk tohumanoranimalhealth is related toaproductmanufacturedandmarketedunder theCode, the informationand recallprocedures (including the rapidalertsystem)definedinRegulation(EC)No178/2002shallapply.

ThetextoftheCodeisdesignedtosetoutgeneralrequirementsandtobeusedbyoperatorsasatooltodeveloptheirownprocedures.

AcompilationofguidanceisprovidedasannextotheCode.Thiscoverstopicsofspecialimportance.Whilethe requirementsof theCodearemandatory foreveryoperator, theGuidanceprovides informationonhowtodealwithspecific issuesinamoredetailedandpracticalwayandmayserveasfurthersupportinginformationtotheCode. Iftheoperatordecidestofollowtheproceduresdescribed intheGuidance,thiswillbecomeapartofitsSafetySystem.Incasethat,forgoodreasons,differentproceduresareused,theoperatormustbeabletoprovideevidenceuponrequestthatheiscomplyingwiththerequirementsoftheCodeaswell.

Both theCodeandGuidancewillbe submitted toperiodical review in linewithemerging/new relevanttechnological,scientificandlegislativedevelopmentsorstatutorymodificationinthesector.

Note:FAMIQSCodeofPractice isapublicdocumentand itscontentscanbefreelyfollowedbyanyfeedadditiveorpremixtureoperator.

RunningsidebysidewiththeCodeFAMIQSAsblhasdevelopedaparalleland independentcertificationsystem that isdescribed in theRules forCertificationdocuments.Participation in theFAMIQSauditablesystemisbasedonvoluntarycommitment.

Please, consult the FAMIQSwebpagewww.famiqs.org to have access to these documents and learnmoreabouthowtoensurecompliancewiththisCodeofPractice.

Version5,1April2009

Page2/39


TABLEOFCONTENTS

1 Introduction .............................................................................................................................................1

2 Scope........................................................................................................................................................5

3 Termsanddefinitions ..............................................................................................................................6

4 ManagementSystem(MS).....................................................................................................................10

4.1. Generalrequirements.................................................................................................... 10

4.2. Managementprinciples................................................................................................. 10

4.3. Generaldocumentationrequirements.......................................................................... 10

5 ManagementResponsibility ..................................................................................................................13

5.1. Managementcommitment............................................................................................ 13

5.2. Qualityandsafetypolicy ............................................................................................... 13

5.3. Responsibility,authorityandcommunication............................................................... 13

5.4. Managementrepresentative......................................................................................... 14

5.5. Managementreview...................................................................................................... 14

6 Resourcemanagement ..........................................................................................................................16

6.1. Provisionofresources ................................................................................................... 16

6.2. Humanresources........................................................................................................... 16

6.2.1. Competence,awarenessandtraining .............................................................................16

6.2.2. Personalhygiene..............................................................................................................16

6.3. Infrastructure................................................................................................................. 17

6.3.1. Basicrequirements ..........................................................................................................17

6.3.2. Requirementsforfacilities,productionareasandequipment........................................17

6.3.2.1. Facilitiesandproductionareas ........................................................................................17

6.3.2.2. Equipment........................................................................................................................18

6.4. Maintenanceandcontrolofmonitoringandmeasuringdevices ................................. 18

6.5. Cleaning ......................................................................................................................... 19

6.6. Pestcontrol.................................................................................................................... 20

6.7. Wastecontrol ................................................................................................................ 21

7 Productrealisation.................................................................................................................................22

7.1. Productrequirements.................................................................................................... 22

7.1.1. Determinationofrequirementsrelatedtotheproduct..................................................22

7.1.2. Complianceoftheproducttotherequirements.............................................................22

7.1.3. Customercommunication................................................................................................22

7.2. HACCPProgram ............................................................................................................. 23

7.3. Designanddevelopment............................................................................................... 24

7.3.1. Developmentofnewproductsandprocesses ................................................................24

Version5,1April2009

Page3/39


7.3.2. Changecontrol.................................................................................................................24

7.4. Handlingofincomingmaterials..................................................................................... 25

7.4.1. Sourcingofincomingmaterials .......................................................................................25

7.4.2. Verificationofincomingmaterials...................................................................................26

7.5. Productionoffinishedgoods......................................................................................... 27

7.5.1. Qualitycontrolandproduction .......................................................................................27

7.5.2. Verificationofprocessesforproduction .........................................................................29

7.5.3. Identificationandtraceability..........................................................................................30

7.5.4. Preservationofproduct ...................................................................................................30

7.6. Transport ....................................................................................................................... 30

7.6.1. Generalrequirements......................................................................................................30

7.6.2. Transportofpackagedgoods...........................................................................................31

7.6.3. Transportofbulkproducts ..............................................................................................31

8 SystemReview .......................................................................................................................................33


8.2. Internalaudits................................................................................................................ 33

9 Controlofnonconformingproducts .....................................................................................................35


9.2. Complainthandlingsystem ........................................................................................... 36

9.3. Recall.............................................................................................................................. 37

9.4. CrisisManagement ........................................................................................................ 38

10 Statisticaltechniques .............................................................................................................................39

Version5,1April2009

Page4/39


2 ScopeTheaimofthisEuropeanCodeofPracticeistoensuresafetyoffeedadditivesandpremixturesby:

minimizingtheriskofadulteratedfeedadditivesandpremixturesenteringthefeed/foodchain; enablinganoperatorto implementtheobjectivesofthefeedhygieneRegulation(Regulation(EC)

No183/2005);and

providingmeasurestoensurethatotherapplicableregulatoryfeedsafetyrequirementsaremet.Feedisconsideredunsafeforitsintendeduseifitislikelytoposeariskto(hasadverseeffecton)humanoranimal health, or if the food derived from foodproducing animals fed the feed is unsafe for humanconsumption.

ThisCodeshallapplytofeedadditivesandpremixtureoperatorsatallstagesoffeedproductionfromthefirstplacingonthemarketoffeedadditivesandpremixturesbasedoncurrentEUlegislation.Thereforeitalso applies to the placing on the market of feed additives and premixtures after import from thirdcountries.

Compliance with FAMIQS does not exonerate the operator from meeting the statutory or regulatoryrequirementsineachcountryinwhichtheoperatorisactive.TheregulatorystatusoffeedadditivescanbecheckedontheCommunityRegisterofFeedAdditives:

(http://europa.eu.int/comm/food/food/animalnutrition/feedadditives/registeradditives_en.htm)

publishedandfrequentlyupdatedbytheEuropeanCommission.

Version5,1April2009

Page5/39


3 TermsanddefinitionsThefollowingtermsanddefinitionsareusedinthisguideandassociatedannexes:

Adequate:The terminologiesadequate,whereappropriate,wherenecessary,orsufficientmeanthat it is up to the business operator in first instance to decide whether a requirement is necessary,appropriate, adequate or sufficient to achieve the objectives of the Code. In determining whether arequirement isadequate,appropriate,necessary,orsufficient,accountshouldbe takenof thenatureofthefeedandofitsintendeduse.(adoptedfromECGuidanceDocument2005onRegulation852/2004/ECandmodified).

Agent:An individualor firmauthorizedtoactonbehalfofanoperatorsuchasbyexecutingcommercialtransactionswithoutevertakinglegalresponsibilityoftheproductandthewayitissuppliedandprovidedintothefeedchain.

Authorisedpersonnel:Personswhohaveskills,permissionandpurposeasspecifiedby jobdescriptions,processdescriptionsormanagement.

Batch:unitofproduction fromasingleplantusinguniformproductionparametersoranumberofsuchunits,whenproduced in continuousorderand stored together. It consistsofan identifiablequantityoffeedand isdetermined tohavecommoncharacteristics, suchasorigin,variety, typeofpacking,packer,consignororlabelling.(COM(2008)124final)

Calibration: The demonstration that a particular instrument or device produces resultswithin specifiedlimitsbycomparisonwiththoseproducedbyareferenceortraceablestandardoveranappropriaterangeofmeasurements.

Carrier:Substanceusedtodissolve,dilute,disperseorotherwisephysicallymodifyafeedadditiveinordertofacilitateitshandling,applicationorusewithoutalteringitstechnologicalfunctionandwithoutexertinganytechnologicaleffectthemselves.(COM(2008)124final)

Carryover:Contaminationofamaterialorproductwithanothermaterialorproductthatoriginatesfromprevioususeofequipmentandwouldalterthequalityandsafetybeyondtheestablishedspecifications.

Check/control:Monitorandmeasureprocessesandproductagainstpolicies,objectivesandrequirementsfortheproductandreportresults.

CIP:Cleaninginplace.

CodeofPractice:Documentidentifyingtheprinciplesoffeedhygieneessentialtoensurethesafetyoffeedforanimalsandinturnthesafetyofanimalproductsintendedforhumanconsumption.

Compound feed: Mixture of feed materials, whether or not containing feed additives, for oral animalfeedingintheformofcompleteorcomplementaryfeed.(COM(2008)124final)

Contamination: The undesired introduction of impurities of a chemical ormicrobiological nature or offoreignmatter, intoorontoarawmaterial, intermediate,feedadditiveorpremixtureduringproduction,sampling,packagingorrepackaging,storageortransport.

Corrective Action: Action to eliminate the cause of a detected nonconformity or other undesirablesituation.Correctiveaction is taken topreventrecurrencewhereaspreventiveaction is taken topreventoccurrence.(ISO9000:2005)

CrossContamination:Contaminationofamaterialorproductwithanotherproduct.

Crisis: An event that represents an immediate and significant threat to animal and/or human healthresulting from the production or supply of unsafe or illegal product; where the product has left theimmediatecontrolofthefeedbusinessoperator.(synopsesfromarticles15&19,Regulation178/2002/EC).

Establishment:Anyunitofafeedbusinessthatcarriesoutthemanufacture/productionand/ortheplacingonthemarketoffeedadditivesandpremixtures.(Regulation183/2005/ECandadapted).

Version5,1April2009

Page6/39


Export:ThereleaseforfreecirculationofaproductortheintentiontoreleaseaproductforfreecirculationintoanonEUmemberstate,whichismanufacturedinanEUmemberstate.

Feedadditives:Substances,microorganismsorpreparations,other than feedmaterialandpremixtures,which are intentionally added to feed orwater in order to perform, in particular, one ormore of thefollowingfunctions:

favourablyaffectthecharacteristicsoffeed;

favourablyaffectthecharacteristicsofanimalproducts;

favourablyaffectthecolourofornamentalfishandbirds;

satisfythenutritionalneedsofanimals;

favourablyaffecttheenvironmentalconsequencesofanimalproduction;

favourably affect animal production, performance or welfare, particularly by affecting the gastro intestinalfloraordigestibilityoffeedingstuffs;or

haveacoccidiostaticorhistomonostaticeffect.

(Regulation1831/2003/ECandRegulation183/2005/EC)

Feedbusiness:Anyundertakingwhetherforprofitornotandwhetherpublicorprivate,carryingoutanyoperation of production, manufacture, processing or distribution of feed additives and premixtures.(Regulation178/2002/ECandadapted).SeeStagesofproduction,processinganddistribution

Feedbusinessoperator: Thenaturalor legalpersons responsible forensuring that the requirementsoffood lawaremetwithinthefeedbusinessundertheircontrol. (Regulation178/2002/ECandadapted).See Feedbusiness.

Feedhygiene:Themeasuresandconditionsnecessarytocontrolhazardsandtoensurefitnessforanimalconsumptionofafeedadditiveorapremixture,takingintoaccountitsintendeduse.(Regulation183/2005/EC).

Feedmaterial:Variousproductsofvegetableoranimalorigin,intheirnaturalstate,freshorpreserved,andproductsderivedfromtheindustrialprocessingthereof.Organicorinorganicsubstances,whetherornotcontaining additives,which are intended for use inoral animal feeding either directly as such,or afterprocessing, in the preparation of compound feedingstuffs or as carriers of premixtures. (Regulation1831/2003/EC)

Feedsafety:High levelofassurancethatthefeed(feedingstuff,feedadditive,orpremixture)willneithercauseharmtothefarmanimalswhenpreparedorconsumedaccordingtotheintendeduse,ortothefinalconsumer.ThroughouttheCode,thewordsafetyistakentohavethesamemeaningasfeedsafety.

Firstplacingonthemarket:TheinitialplacingontheEuropeanUnionmarketofanadditiveorpremixtureafter itsmanufactureorthe importofanadditiveorpremixture. (Seeplacingon themarket). (Regulation1831/2003/EC)

Flowdiagram:Asystematicrepresentationofthesequenceofstepsoroperationsusedintheproductionormanufactureofaparticularfooditem.(CodexAlimentarius)

HACCP (HazardAnalysis and Critical Control Point):A systemwhich identifies, evaluates, and controlshazardstofeedsafety.(CodexAlimentariusandmodified)

Hazardanalysis:Theprocessofcollectingandevaluatinginformationonhazards,andconditionsleadingtotheir presence, to decidewhich are significant for feed safety and therefore shall be addressed in theHACCPplan.

Hazard: Biological, chemicalorphysical agent in the feed chainwith thepotential to cause an adversehealtheffectforanimalsorconsumers.(Regulation178/2002/EC)

Homogeneity: The degree to which a property or a constituent is uniformly distributed throughout a

Version5,1April2009

Page7/39


quantityofmaterial.(PAC,1990)

Import: The release for free circulation of a product or the intention to release a product for freecirculation into an EU member state, which is manufactured in a non EU member state. (Regulation882/2004/ECandmodified)

Incoming material: A general term used to denote raw materials delivered at the beginning of theproductionchain(e.g.reagents,solvents,processingaids,feedmaterials,feedadditivesandpremixtures).

Intermediate:Anymaterialwhichhasbeenprocessedbytheoperatorbeforethefinalproductisobtained.

Manufacture/production: All operations encompassing receipt of materials, processing, packaging,repackaging, labelling,relabelling,qualitycontrol,release,storage,anddistributionof feedadditivesandpremixturesandrelatedcontrols.

Minerals: Feed materials may include minerals mentioned in Annex Part B, chapter 11, of Directive96/25/EC.

Operator:Seefeedbusinessoperator.

Placingon themarket:Holdingproducts for thepurposesof sale, includingoffering for saleor for thepurposesofanyother formof transfer,whetherornot freeofcharge,tothirdparties,andthesaleandotherformsoftransferthemselves.(Regulation178/2002/EC)(Seefirstplacingonthemarket).

Plan: To establish the objectives and processes necessary to deliver results in accordance with theoperatorspoliciesregardingqualityandsafety.

Premixtures:Mixturesoffeedadditivesormixturesofoneormorefeedadditiveswithfeedmaterialsorwaterusedascarriers,notintendedtodirectfeedingtoanimals.(Regulation1831/2003/EC)

Preventive Action: Action to eliminate the cause of a potential nonconformity or other undesirablepotentialsituation.Preventiveactionistakentopreventoccurrencewhereascorrectiveactionistakentopreventrecurrence.(ISO9000:2005)

Procedure:Operations tobeperformed,precautions tobe takenandmeasures tobeapplieddirectlyorindirectlyrelatedtothemanufacturingofamaterial,feedadditiveorpremixture.(ModifiedfromICHQ7A).

Processing aids: Any substance not consumed as a feedingstuff by itself, intentionally used in theprocessing of feedingstuffs or feed materials to fulfil a technological purpose during treatment orprocessingwhichmayresultintheunintentionalbuttechnologicalunavoidablepresenceofresiduesofthesubstanceor itsderivatives in the finalproduct,provided that these residuesdonothave any adverseeffectonanimalhealth,humanhealthortheenvironmentanddonothaveanytechnologicaleffectsonthefinishedfeed.(Regulation1831/2003/EC)

Quality:Degreetowhichasetofinherentcharacteristicsfulfilsrequirements.(ISO9000:2005)

QualityManual:Documentspecifyingthequalitymanagementsystemofanorganisation.(ISO9000:2005)

Rawmaterial:Anymaterialwhichentersthemanufacturingprocessofthefeedadditiveand/orpremixture.

Recall:Anymeasureaimedatachievingthereturnofadangerousproductthathasalreadybeensuppliedormadeavailabletoconsumersbytheoperator.(RegulationNo2001/95/EC)

Record:Writtendocumentscontainingactualdata.

Reworking: Any appropriate manipulation steps in order to ensure a feed additive or premixture willconformtospecifications.

Risk:Afunctionoftheprobabilityofanadversehealtheffectandtheseverityofthateffect,consequentialtoahazard.(Regulation178/2002/EC)

Safety:Seefeedsafety.

Version5,1April2009

Page8/39


Shall:Compliancewitharequirementwhichismandatoryforcompliancewiththisstandard.(ObligationtofollowtheexactrequirementasstatedbythisCode).

Shelf life: A defined time period for which a product fully complies with it is specification if storedappropriately.

Should:Meansmustandtheactivities,descriptionsorspecificationsaccompaniedbythewordshouldareintendedtobemandatory,unlessthemanufacturerisabletodemonstratethattheactivity,descriptionorspecificationisinapplicableorcanbereplacedbyanalternativewhichmustbedemonstratedtoprovideatleastanequivalentlevelofqualityandsafetyassurance.(OperatorsareobligatedtoachievethegoaloftheCodebyappropriatemeans).

Sign/signature:Confirmationofanauthorisedperson inwritingorbyelectronicmeanswithcontrolledaccess.

Specification:A listoftests,referencestoanalyticalprocedures,andappropriateacceptancecriteriathatarenumerical limits, ranges,orother criteria for the testdescribed. Itestablishes the setof criteria towhich a material shall conform to be considered acceptable for its intended use. Compliance tospecificationmeans that thematerial,when testedaccording to the listedanalyticalprocedures,meetsthelistedacceptancecriteria.

Subcontracting The delivery of a service, pertaining to the product, provided by a third party to theoperatorwherenochangeinownershipoftheproducttakesplace.

Sufficient:SeeAdequate.

Stages of production, processing and distribution:Any stage, including import, from and including theprimaryproductionofafood,uptoandincludingitsstorage,transport,saleorsupplytothefinalconsumerand,where relevant, the importation,production,manufacture,storage, transport,distribution,saleandsupplyoffeed.(Regulation178/2002/EC)

Traceability:Theabilitytotraceandfollowafood,feed,foodproducinganimalorsubstance intendedtobe,orexpected tobe incorporated intoa foodor feed throughall stagesofproduction,processinganddistribution.(Regulation178/2002/EC)

Verification:Applicationofmethods,procedures,testsandotherevaluations,inadditiontomonitoring,todeterminecompliancewitharequirement.

Whereappropriate:Seeadequate.

Wherenecessary:SeeAdequate.

Writtendocuments:Paperprinteddocuments.Thesemaybesubstitutedbyelectronic,photographic,orotherdataprocessingsystemsprovidedthatthedatawillbeappropriatelystoredduringtheanticipatedperiodofstorage(archive)andcanbemadereadilyavailableinalegibleform.

Version5,1April2009

Page9/39


4 ManagementSystem(MS)4.1. Generalrequirements

Theoperatorshallestablish,document,implementandmaintainamanagementsysteminaccordancewiththerequirementsofthisCode.

TheMSshallbecontinuallyadaptedinlinewithregulatorydevelopmentsandcustomerrequirements.

Thestructureof theMSshallbespecific to theorganisationof theoperatorandshould includepolicies,requirementsandprocessdocumentsthatreflectcommitmenttofeedsafety.

TheMSshallensurethatallactivitiescarriedoutbytheoperatorthatcouldimpactonthequalityandfeedsafetyoftheproductareconsistentlydefined,implementedandmaintainedatalllevelsintheorganisation.

The MS shall include quality procedures to ensure that the product consistently conforms to theauthorizationofthefeedadditiveandthespecificationofthepremixture(s)thereof.

Ensurethat:

AdocumentedMSisinplace; TheMSincludesregulatory,safetyandcustomerrequirements; TheMSiscoveringalltheoperatorsactivities; Otheractivitiesarenotconflictingwiththefeedsafetyrequirements.

4.2. Managementprinciples

OperatorsshouldbeabletodemonstratethatitsemployeesareawareoftheircontributiontofeedsafetyandrelevantEUlegislationassociatedtotheirvarioustasks.

Each operator shall perform and record the evaluation of risks associated with processes within hisoperationsandsubsequentlydefinecontrolstobeappliedtothesebasedonHACCPprinciples.

Effective change control and investigative procedures shall be in place tomanage product history anddeviationsfromplannedprocedure.

Proceduresshallexistforthetimelynotificationoftheappropriatemanagementofoccurrencesthatmightposea threat toproductqualityand safety. These include forexample,complaints,product recall,andauditfindings.

Formoredetailed informationontherelevant legislationonfeedadditivesandpremixturesseeAnnex8GuidanceoncompliancewiththeEUlegislationonfeedadditivesandpremixturesforproductrealisation.

Ensurethat:

Employeescommitmenttofeedsafetyandqualitycanbedemonstrated; HACCPprinciplesareapplied; Aneffectivechangecontrolsystemisimplemented; Managementareinformedincaseofthreatstoproductqualityandfeedsafety; A system is inplace toensure thatmanagement iskeptupdatedonall relevant legislation, feedand food safety

issues,andotherrelevantguidelines.

4.3. Generaldocumentationrequirements

TheoperatorshallhaveasystemofdocumentationwhichreflectsallaspectsofthisCode.ThesystemofdocumentationshallreflectinparticulartheapplicationofHACCP.

Version5,1April2009

Page10/39


Recordsshallcontainallrelevantdatathatwillpermitinvestigationofanynonconformanceordeviation(s)fromplannedprocedure(s).

Allqualityandsafetyrelatedactivitiesshallberecordedimmediatelyaftertheyhavebeenperformed.

Thedesignandnatureofuseofrecordsisatthediscretionoftheoperator.

MSdocumentationshouldinclude:

a) awrittenqualityandsafetypolicy;

b) aQualityManual;

c) documentedproceduresandrecords;and

d) informationneededbytheoperatortoensuretheeffectiveplanning,operation,andcontrolofitsprocesses.

TheQualityManualshouldinclude:

a) thescopeoftheMS,includingdetailsofandjustificationforanyexclusion;

b) qualityproceduresestablishedaspartoftheMS,orreferencetothem;

c) qualityproceduresinsupportoftheHACCPprogram;

d) HACCPprocedurestoensurefeedsafety.

Minimumdocumentsrequiredinclude:

a) specificationsandtestingproceduresforincomingmaterialsandfinishedproduct;

b) masterformulaeandoperatinginstructionsforeachproductorgroupofproducts;

c) batchprocessingrecordsforeachproduct;and

d) StandardOperatingProcedures(SOPs).

Documentsshould:

a) haveunambiguouscontents:thetitle,natureandpurposeshallbeclearlystated;

b) beapproved,signedanddatedbyappropriateauthorisedpersons.Nodocumentshallbechangedwithoutauthorisation;and

c) bekeptuptodate.

Version5,1April2009

Page11/39


Ensurethat:

Awrittenqualityandsafetypolicyexists; AQualityManualisinplace; Documentedproceduresandrecordsareavailable; ThescopeoftheMSisdefined; QualityproceduresareestablishedaspartoftheMS; QualityprocedurescovertheprerequisiteprograminsupportoftheHACCPprogram; HACCPproceduresaresufficienttoensurefeedsafety; Specificationsandtestingproceduresforincomingmaterialsandfinishedproductsaredocumented; Masterformulaeandoperatinginstructionsforeachproductorgroupofproductsareinplace; Processingrecordsforeachbatchofproductareavailable; StandardOperatingProcedures(SOPs)forallactivitiesunderthescopeoftheMSaredocumented; Documentsareunambiguousandincludetitle,natureandpurpose; Documentsareapproved,signedanddatedbyappropriateauthorisedpersons. Alldocumentsarekeptuptodate.

Version5,1April2009

Page12/39


5 ManagementResponsibility5.1. Managementcommitment

Management shall be committed to the implementation of the Code and the companies own specificqualityrequirementsinordertoensurefeedsafetyandpredefinedqualityofproducts

Ensurethat:

Managementcommitmenttofeedsafetyandqualitycanbedemonstrated

5.2. Qualityandsafetypolicy

Managementshall:

a) Establishandput inplaceaqualityand safetypolicyandensure thatobjectivesareestablishedclearlystatingthecompaniesobligationtoproducesafe, legalfeedadditivesandtorespecttheircustomersrequirements.

b) Thispolicyshallbecommunicatedthroughouttheorganisationandunderstoodbyallstaffinvolvedintheproductionoffeedadditives.

c) Providethenecessaryresourcesforthefulfilmentofthequalityandsafetypolicy.

d) EnsureallkeyaspectsoftheManagementandHACCPsystemsaredocumented,reviewed,updatedandcommunicatedtokeystaffasfrequentlyasmightbenecessary.

Ensurethat:

Thequalityandsafetypolicyspecifiestheoperatorsobjectivesincludingregulatoryandcustomerrequirements; Thepolicyisadequatelycommunicated; Theoperatorhasthebasicresourcesnecessarytofulfilthestatedobjectives; ManagementandHACCPsystemsaredocumented,reviewed,updatedandcommunicatedtokeystaff.

5.3. Responsibility,authorityandcommunicationManagementshall:

a) appointaHACCPteamandteamleader;

b) define the scope of the HACCP system, by identifying the products/product categories andproduction sites which are covered by the system and ensuring that safety objectives areestablishedaspartofthesystem;

c) EnsureJobdescriptionsareavailablethatclearlydefinetheresponsibilitiesofallstaff involved intheproductionoffeedadditivesandpremixtures;

d) identifyandrecordanyproblemsandremedialactionswithregardtoproductsquality,safetyandtheoperatorsmanagementsystem;

e) Initiate action(s) to prevent the occurrence of nonconformities relating to product quality andsafety;and theoperator shallprovideadequate resources for the implementation,managementandcontroloftheHACCPsystems.FurtherdetailsonHACCPrequirementscanbefoundinsection7.2;

Version5,1April2009

Page13/39


f) Assigntheresponsibilityandauthorityforensuringcompliancewithregulatoryrequirementsandindustrycodesofpracticetoclearlyidentifiedcompetentpersons;

g) Issue,maintainandmakeavailabletotheoperationsstaffandexternalbodiesanorganisationalchartoftheoperationandjobdescriptions.

Ensurethat:

AsuitablyqualifiedHACCPteamleaderisappointed; ThescopeoftheHACCPsystemisclearlydefined; Jobdescriptionsexistforeachindividualorgroupofindividuals; AsystemisinplacetoidentifyandcorrectproblemswithinthemanagementandHACCPsystems; Asuitablyqualifiedpersonisappointedtoensurecompliancewithregulatoryrequirements; Anorganisationalchartisavailable.

5.4. Managementrepresentative

Seniormanagementshouldappointamemberofmanagementwhoshallhaveresponsibilityandauthoritythatincludes:

a) ensuring that processes needed for the management and HACCP systems are established,implementedandmaintained;

b) reportingtotopmanagementontheperformanceofthemanagementsystemsandanyneedforimprovement;and

c) ensuringthepromotionofawarenessofcustomerrequirementsthroughouttheoperator.

Ensurethat:

Amanagementrepresentativewithresponsibilityforqualityandsafetyisappointed. Themanagementrepresentativereportstotopmanagement. Theresponsibilityincludespromotionofawarenesstowardscustomerrequirements.

5.5. Managementreview

Management shall review the effectivenessof theManagement andHACCP systems at regulardefinedintervals:

a) Recordsofthisreviewshallbemaintained;

b) Theneed toupdateorchange theManagementandHACCPSystemsshallbeevaluatedat thesereviews;

c) Resultsfromexternalandinternalauditsshallbereviewed;

d) Customercomplaintsandrequestshallbereviewed;

e) Internalproblemsandchangestotheoperationprocessesmustbereviewed;

f) Decisions made to change any aspect of the Management and HACCP Systems shall becommunicatedtokeystaff;

Version5,1April2009

Page14/39


g) ManagementshallensureasystemisinplacetoaudittheManagementandHACCPSystems.

Ensurethat:

AdocumentedprocedureexistsformanagementtoreviewthesuitabilityandeffectivenessoftheMSandHACCP; Recordsofthisreviewareavailable; Thereviewisdoneperiodicallyatpredefinedintervals; Conclusionsdrawnandactionstakenaredocumentedaspartofthereview; Anyactionsarecommunicatedtokeypersonnelwithintheorganisation.

Version5,1April2009

Page15/39


6 Resourcemanagement6.1. Provisionofresources

Managementshallidentifyandprovidethenecessaryresourcesinorderthatthemanufacture,processing,storageandtransportofproductsarecarriedoutinanefficientandsafemanner.

Feed businesses must have sufficient staff possessing the skills and qualifications necessary for themanufactureoftheproductsconcerned.

Managementshallprovidesufficientandappropriatelydesignedinfrastructure,workenvironmentfacilities,productionareasandequipment.

Providewater of a suitable quality, e.g. potablewater, so that the product complieswith feed safetyrequirements.

Ensurethat:

Anorganisationalchartexistsandisupdated; Appropriatepersonshavebeenassignedresponsibilitiestocomplywithexternalrequirements; Thedesignisappropriate.

6.2. Humanresources

6.2.1. Competence,awarenessandtraining

Employees andmanagers shall have the necessary skills, competencies, qualifications and training andawareness to be able to effectively execute their respective tasks, thereby ensuring the conformity ofproduct(s)totheexpectedqualityandfeedsafety(specificallytheHACCPteam).

Educationandtrainingofpersonnelshallbedocumentedandmaintained.

Staffshallbetrained inappropriatestandardsofhygienicbehaviour inordertocontributetotheoverallfeedsafetypartofthefoodchain.

Ensurethat:

Thestaffissufficientandskilledtocomplywithexpectedtasksandrequirements; Jobdescriptionsareavailableandupdated.

6.2.2. PersonalHygiene

Ensurethatpersonnelhygienefacilitiesareclearlyandsuitablydesignated,locatedandmaintained.

Provideappropriateworkwearsuchasprotectiveclothingandsafetyfootwear,andmaintaintheminhygienicconditions.

Ifglovesareworn,controlthatthereisnoriskofcontaminationofthefinishedproductfromthem.

Establishclearrulesonsmokingandeating/drinkingonsite.Ifnecessary,provideseparatefacilitiesforthese.

Version5,1April2009

Page16/39


Ensurethat:

Necessarycompetenceisavailableindisciplinesconcerning:o Feedsafety;o HACCP(see7.2HACCPprogram);o Hygiene;o Quality;o Healthandsafety;o Environment.

Levelofcompetenceisdocumentedandmaintained. Thereisasufficientlevelonpersonalhygienefacilitiesandpersonelhygiene.

6.3. Infrastructure

6.3.1. Basicrequirements

Whereapplicable,theoperatorshallprovideappropriateworkenvironment in linewith localRegulationstoachieveproductconformity.

Adequate ventilation; controlable humidity and temperature temperature setting; lighting and hygienicdesignofplantsandequipmentshallbeprovided.

6.3.2. Requirementsforfacilities,productionareasandequipment

Thelayout,design,constructionandsizeofthefacilitiesandequipmentshall:

a) permitadequatecleaningand/ordisinfection;

b) besuchastominimisetheriskoferrorandtoavoidcontamination,crosscontaminationandanygenerallyadverseeffectsonthesafetyandqualityofthefeeds.

6.3.2.1. Facilities&productionAreas

Wherenecessary,ceilingsandoverheadfixturesmustbedesigned,constructedandfinishedtopreventtheaccumulation of dirt and to reduce condensation, the growth of undesirable microorganisms and thesheddingofparticlesthatcanaffectthesafetyandqualityoffeed.

Ventilation systems and devices shall be sufficient in number and capacity to prevent grease orcondensationfromcollectingonwallsandceiling.

Ifnecessarytokeeproomsfreeofexcessivesteamandcondensation,mechanicalventilationofsufficientcapacityshallbeprovided.

Ifnecessary,heating,coolingorairconditioningsystemsshallbedesignedand installedsothatairintakeorexhaustventsdonotcausecontaminationofproducts,equipmentorutensils.

Lightingmustbeofsufficient intensity toensurethathygienicconditionsaremaintained throughouttheproductionandstorageareas,aswellaswhereequipmentandutensilsarecleaned,inhandwashingareasandtoilets.

Waterusedinfeedmanufactureshallbeofsuitablequality.

Version5,1April2009

Page17/39


Itshouldbeensuredthatdrainagelinesandsewagesystemsarewatertightandofsufficientcapacity.

Drainagefacilitiesmustbeadequateforthepurposeintended;theymustbedesignedandconstructedtoavoidtheriskofcontamination.

6.3.2.2. Equipment

Manufacturing equipment should be located, designed, constructed and maintained to suit themanufactureoftheproductsconcerned.

The equipmentmust be designed to facilitatemanual or Cleaning In Place (CIP) and/or disinfection byhavingsurfacesthataresmooth,freeofsharpangles,corners,crevicesorsmoothwelds.

Whereapplicable,equipmentmustbeplacedaway fromwalls toalloweasyaccess for cleaningand topreventpestinfestation.

Ensurethat:

Thefacilityisdesignedtofacilitateagoodenvironmentasdescribedin6.3.2.1; Thefacilityisdesignedto,ifnecessary,makeiteasytoclean; Thefacilityissuitabletominimizefeedsafetyrisks; Necessaryutilitiesareavailable,e.g.:

o Potablewaterorotherwaterquality;o Steam;o Pressuredair;o Heatingsystem;o Extractionunits;o Otherrelevantutilitysystem.

6.4. Maintenanceandcontrolofmonitoringandmeasuringdevices

Adocumentedmaintenanceprogramformanufacturingoperationsshallbeimplemented.

Recordsshallbekeptofworkcarriedout.

Theoperatorshallestablishprocessestoensurethatmonitoringandmeasurementcanbecarriedoutinamannerconsistentwithdocumentedprocedures.

All scales andmeteringdevicesused in themanufactureof feeds shallbe appropriate for the rangeofweightsorvolumestobemeasuredandshallbetestedforaccuracyregularlyaccordingtotherisks.

Wherenecessarytoensurevalidresults,measuringequipmentshall:

a) be calibrated or verified at specified intervals or prior to use, against measurement standardstraceabletointernationalornationalmeasurementstandards.Wherenostandardsexist,thebasisforcalibrationorverificationshallberecorded;

b) beadjustedorreadjustedasnecessary;

c) beidentifiedtoenablethecalibrationstatustobedetermined;

d) besafeguardedfromadjustmentsthatwouldinvalidatethemeasurementresult;and

Version5,1April2009

Page18/39


e) beprotectedfromdamageanddeteriorationduringhandling,maintenanceandstorage.

Inaddition, theoperatorshallassessandrecord thevalidityof thepreviousmeasuringresultswhen theequipment is foundnot toconform to requirements. Theoperator shall takeappropriateactionon theequipment and any product that might have been affected. Records of the results of calibration andverificationshallbemaintained.

When used in the monitoring and measurement of specified requirements, the ability of computersoftwaretosatisfytheintendedapplicationshouldbeverified.Thisverificationshouldbeundertakenpriortoinitialuseandreconfirmedasnecessary.

Ensure that:

A formal calibration system is in place; This includes items to be calibrated; Appropriate calibration intervals are defined; Calibration results are documented; A formal preventive maintenance system exists; Appropriate maintenance intervals are defined; Maintenance work is documented; Maintenance work does not interfere with product safety.

6.5. Cleaning

Acleaningand inspectionprogrammeshallbe introducedanddocumented.Effectivenessoftheprogramshallbedemonstrated.

Ensurethatallinsideandoutsideareas,buildings,facilitiesandequipmentarekeptcleanandingoodstatetofunctionasintendedandtopreventcontamination.

Containersandequipmentusedforthetransport,storage,conveying,handlingandweighingoffeedshallbekeptclean.

A schedule shall be implemented with method, agents used and frequency of cleaning includingresponsibilitiesforthetasks.

Cleaning canbe carriedoutby e.g.physicalmethods like scrubbing and vacuum cleaning and chemicalmethodsusingalkalineoracidicagentsandmethodswithouttheuseofwater.

Whereappropriatedisinfectionmaybenecessaryaftercleaning,buttracesofdetergentsanddisinfectantsshallbeminimised.

Agentsshallbeusedandstoredaccordingtothemanufacturersinstruction(s),clearlylabelled,separatelystored from rawmaterials and finishedproducts and applied properly to avoid contaminationof rawmaterialsandfinishedproducts.

Afterawetcleaningprocedure,themachinerycoming intocontactwithfeedshallbedryenoughforthenextproduction

Version5,1April2009

Page19/39


Ensurethat:

Aformalcleaningprogramexists,covering:o Dailyhousekeeping;o Periodicdeepcleaning;o Cleaningaftermaintenance;

Theprogramdefinesresponsibility. Postevaluationiscovered. Cleaningrecordsarefilledincurrently. Proceduresoncleaningofequipmentexist,andsupporthygieneandfeedsafety. Employeesaretrainedincleaningproceduresandthetrainingisdocumented.

6.6. Pestcontrol

Thereshouldbeawrittenplanforpestcontrolincludingdescriptionofperiodicinspections.Effectivenessoftheplanshallbedemonstrated.

Ascheduleshallbeimplementedwithareas,facilitiesandequipmenttobeinspectedincludingfrequencyaswellasdetailsofpesticides,fumigationagentsortrapsusedaswellasresponsibilitiesforthetasks.

Pesticides,fumigationagentsortrapsusedshallbesuitableandcomplywithlocalRegulationsforthepurposeconcerned,usedandstoredaccordingtothemanufacturersinstruction,clearlymarkedandseparatelystoredfromrawmaterialsandfinishedproductsandappliedproperlytoavoidcontaminationofrawmaterialsandfinishedproducts.

Thepositionsoftrapsandbaitstationsshallbemapped.

TheHACCPplanshallconsidertheriskofcontaminationduetoinfestationoruseofpesticides.

Spoilageanddustshallbecontrolledtopreventpestinvasion.

Theresultsofthepestcontrolarepartoftheyearlymanagementreview.

Windowsandotheropeningsmust,wherenecessary,beproofedagainstpests.Doorsmustbeclosefittingandproofedagainstpestswhenclosed.

Ensurethat:

Aformal(documented)preventivepestcontrolsystemisinplace. Theresponsibility:Inhouseorcontracted. Ensurethatrelevantpreventivemeasuresaretaken,re.:

o Rodents,outsideandinside;o Insects,flyingandcrawling;o Birds;o Otherrelevantpests.

Ensureamaporschematicsofpreventivemeasuresshowingthelocationsexistandisupdated. Pestactivitiesaredocumented. Appliedpesticides/chemicalsaresuitableforthepurpose(ProductDataSheet). Ensurelegalityofthepesticide/chemicals. Theplantismaintainedreasonablyclearofinfestation.

Version5,1April2009

Page20/39


6.7. Wastecontrol

Wasteandmaterialsnotsuitableasfeedshouldbeisolatedandidentified.Anysuchmaterialscontaininghazardouslevelsofveterinarydrugs,contaminantsorotherhazardsshallbedisposedofinanappropriatewayandnotusedasfeed:

a) Identifywasteclearlyanddisposeinamannerwhichavoidscontaminationofrawmaterialsandfinishedproducts;

b) Storewasteinclosedorcoveredcontainersatdefinedwasteaccumulatingareas;

c) Cleanwasteaccumulatingareasregularly;

d) Wastecontainersshouldbeclearlymarkedanddesignatedforthatpurposeonly;

e) Sewage,wasteandrainwatershallbedisposedofaccordingtolocalRegulationsandinamannerwhichensuresthatequipmentandthesafetyandqualityoffeedisnotaffected.

Ensurethat:

Wastematerialsareproperlyidentifiedtoavoidmixupwithproductionmaterials; Wasteishandledproperlytoavoidrisksforworkersorenvironment,bothinternallyandexternally.

Version5,1April2009

Page21/39


7 Productrealisation7.1. Productrequirements

7.1.1. Determinationofrequirementsrelatedtotheproduct

Theoperatorshalldetermine:

a) statutoryandregulatoryrequirementsrelatedtotheproduct;

b) requirementsspecifiedby thecustomer, includingrequirementsrelated todeliveryandpostdeliveryactivities;and

c) requirementsnotstatedby thecustomerbutnecessary forspecifiedor intendeduse,whereknown.

Ensurethat:

Asystemtoidentifyexternalrequirementsisimplemented; Theexternalrequirementsarecommunicatedandcompliedwith; Requirementsandcompliancearedocumented; Requirementsspecifiedbycustomersarecontrolledandimplemented.

7.1.2. Complianceoftheproducttotherequirements

Theoperatorshallmonitorthecomplianceofproductswiththerelevantproductrequirementsandshallensurethat:

a) productrequirementsaredefined;

b) theoperatorhastheabilitytomeetthedefinedrequirements;and

c) theexistenceandhandlingofproducts forexportoutside theEUandwhich cannot, fromaregulatorypointofview,beplacedontheEUmarket,isdescribedintheoperator'sMS.Iftheoperator markets such nonEU compliant products, the operator should maintain a list ofproductswhichmaybemarketedintheEUandthosewhichmaybemarketedoutsidetheEUonly.

Shouldproductrequirementschange,theoperatorshallensurethatrelevantdocumentsareamendedandthatrelevantpersonnelaremadeawareofthechangedrequirements.(Seealsosection7.3.2).

Ensurethat:

Proceduresareinplacetocomplywithidentifiedrequirements.

7.1.3. Customercommunication

Theoperatorshalldetermineandimplementeffectivearrangementsforcommunicatingwithcustomersinrelationto:

a) productinformation;

b) enquiries,contractsororderhandling,includingamendments;and

c) customerfeedback,includingcomplaints.

Version5,1April2009

Page22/39


Ensurethat:

Relevantproductinformationisinplace; Theinformationiscommunicatedtothecustomer; Informationprovidedbycustomersisreceivedandimplemented.

7.2. HACCPProgram

ThepurposeoftheHACCPprogram istoensureproduct(feed)safety inacontrolledmannerbasedonasystematicprocedure.Theprogramcomprisesanyactivitiesandprocesssteps ranging frompurchaseofrawmaterialstotransportofthefinishedproducts.

Inthehazardanalysisasurveyshouldbeconductedtoidentifyallpotentialhazards.Basedonthisanalysis,hazardsshallbeclassifiedaccordingtorisk,andpossibleCriticalControlPoints (CCPs)shallbe identifiedandcontrolproceduresestablished.

Specialattentionshallbepaidtohazardsrequiringspecificcontrolmeasures.

It is recommended that operators follow the guidance for application ofHACCP provided in the CodexAlimentariusGuidelines,whicharebasedonthefollowing7principles:

1. Conductahazardanalysis.

2. Determinethecriticalcontrolpoints(CCPs).

3. Establishcriticallimits.

4. EstablishasystemtomonitorthecontrolofeachCCP.

5. Establishthecorrectiveactiontobetakenifcontrolsshouldfail

6. Establish a procedure to verify that all the aspects of the HACCP system are workingeffectively.

7. Document all procedure and records to demonstrate the HACCP system is workingeffectively.

For more detailed information on how HACCP principles can be applied see the Guidance on theimplementationofHACCP(Annex1).SeealsothisAnnexfor informationonHACCPanalysisandhowtostudytherisksassociatedtovariousproductionprocesses.

Among the risks to be considered during a HACCP analysis are issues such as homogeneity and/ormicrobiology.Formore informationseetheGuidanceonhomogeneity(Annex4)andtheGuidanceonbiologicalhazards(Annex7).

FurtherrequirementsonHACCPcanbefoundinthefollowingsectionsoftheCode:

3 Termsanddefinitions

4.2 Managementprinciples

4.3 Generaldocumentationrequirements

5.2 Qualityandsafetypolicy

5.3 Responsibility,authorityandcommunication

5.4 Managementrepresentative

5.5 Managementreview

Version5,1April2009

Page23/39


6.2.1 Competence,awarenessandtraining

6.5 Cleaning

6.6 Pestcontrol

7.3.1 Developmentofnewproductsandprocesses

7.4.1 Sourcingofincomingmaterials

7.5.1 Qualitycontrolandproduction

7.5.2 Verificationofprocessesforproduction

7.6.1 Transport.Generalrequirements

9.1 Controlofnonconformingproducts.Generalrequirements

7.3. Designanddevelopment

7.3.1. Developmentofnewproductsandprocesses

Theoperatorshallplanandcontrolthedesignanddevelopmentofproductsorprocessesrelatedtosafety.

Thesafetyof feedadditivesshallbeassuredduring thedevelopmentalstagesofanewproduct throughapplicationoftheHACCPprinciples.

Ensurethat:

Developmentplansareissuedpriortorelevantphasesofthedevelopmentprocess; Thedevelopmentplanconsidersrisksrelatedtosafety; HACCPisconsidered.

7.3.2. Changecontrol

Designanddevelopmentchangesshallbeidentifiedandcorrespondingrecordsmaintained.

All changes should be reviewed, verified and validated, as appropriate, and approved beforeimplementation.

The reviewofdesignanddevelopmentchanges shall includeevaluationof theeffectof the changesonproductsafety.

Recordsoftheresultsofthereviewandanynecessaryactionsshallbemaintained.

Ensurethat:

Aformalchangecontrolprocedureexists; Changesareapprovedbeforeimplementation; Changesarecontrolledanddocumented; Changesimplementedarereviewed,verifiedandarchived; Safety,qualityandregulatoryrequirementscoveredbythechangecontrolprocedure.

Version5,1April2009

Page24/39


7.4. Handlingofincomingmaterials

7.4.1. Sourcingofincomingmaterials

Theapprovalofgoodqualitysuppliersand theselectionofexcellent ingredientsareakeyaspectofanyoperatorsqualityand safetymanagement system(s).Poor rawmaterialscan result in theproductionofpoorquality finishedproductandmayalsocompromise the safetyof theoperatorsentireprocess. Alloperatorsshould thereforeplacespecialemphasisonensuring theirsuppliersand ingredientsareof therequiredqualityandstandard.

Managementrequirements

a) Purchasing information shall describe the product to be purchased, including, where appropriate,requirementsforapprovalofpurchasedproduct.

b) Selectionandapprovalofallrawmaterialsshallincludetheirorigin,transport,storage,andhandling.

c) Anypotentialhazardassociatedwitharawmaterialshallbedocumented.

d) Each rawmaterial shallhaveawritten specification, includingqualityagreement,which isamendedwhenchangeofdocumentedparameterstakesplace.

e) Inadditiontotheanalyticalcharacteristicsoftherawmaterial,thespecificationshouldinclude,whereappropriate, details of any undesirable substance with which the raw material may typically beassociated, and anyotherhazardsor limitations associatedwith the rawmaterialwhichhavebeenconsideredintheoperatorsHACCPsystem.

f) Whereappropriate,requirementsforanalyticalmonitoringshallbedefined.

g) In case thematerial is a feed additiveorpremixture imported fromoutside the EuropeanUnion, awrittenconfirmationof itscompliancewiththecurrentEUfeedRegulations issuedbythesupplier isneeded. Documentation is required that these feed additives and premixtures are produced incompliancewiththerequirementsofAnnex8GuidanceoncompliancewiththeEUlegislationonfeedadditivesandpremixturesforproductrealizationtothisCode.

h) There shallbea listof internallyapproved suppliersandeach supplier shallbe subject toperiodicalreview.

i) Theoperatorshallevaluateandselectsuppliersbasedontheirabilitytosupplyproductsinaccordancewith the operators requirements. Criteria for selection, evaluation and reevaluation shall beestablished.

j) Recordsofany relevantanalyticalandmonitoring resultsandof theevaluationsof the supplierandnecessaryactionsarisingfromthatevaluationshallbemaintained.

Realizationrequirements

k) Every rawmaterial shallbeevaluated toassessanypotentialhazardassociatedwith it; this shallbecarriedoutaccordingtoHACCPprinciplesforallmaterialsfallingunderthescopeoftheRegulation(EC)No183/2005onFeedHygiene.

l) There shallbea check that these feedadditivesandpremixturesarebeingproduced in compliancewiththerequirementsofthisCode,seeAnnex8GuidanceoncompliancewiththeEU legislationonfeedadditivesandpremixturesforproductrealization.

Version5,1April2009

Page25/39


Ensurethat:

Newsuppliersarecoveredbyanapprovalprocess; Approvedsuppliersaredocumented,reviewed,reevaluatedandthedocumentationisuptodate; Thereviewisdoneperiodicallyatapredeterminedinterval; Purchasedincomingmaterialhasanagreedspecification; Specificationscomplywithfeedsafetytopicsandlegislativerequirements.

7.4.2. Verificationofincomingmaterials

Eachbatchenteringthesiteshallbeuniquelyregisteredbymeansofabatchnumber,fullnameofproduct,dateofreceiptandquantityreceived.Anydamageshallbereportedtoanappropriateresponsibleunit,e.g.thequalitycontrolunit.

Iftheincomingmaterialisdeliveredinbulk,areceiptandstorageproceduremustbeinplace.Ifsilosareemptied,thisshallberecordedandcleaningmustbeevaluated.

Incomingmaterialsshouldbecheckedandformallyapprovedpriortouseaccordingtowrittenprocedures.Samplesofthesematerialsshouldberetained.Whereappropriate,aretainedsampleshallbeavailableforatleasttheshelflifeofthematerial,eitheratthesuppliersortheoperators.FormoredetailedinformationonpossiblesamplingproceduresseetheGuidanceonsampling(Annex6).

Handlingof incomingproduct should be in accordancewith its status, for example, a received productwhichisdeemedunfitforusemustbeidentifiedassuchandsegregatedfromthoseproductsreleasedforuse. In the same light, perishable materials should be treated as appropriate to ensure theirwholesomenessbeforeuse.

Ifincomingmaterialsarerejectedandthusnotincorporatedforanyreasonrelatedtoproductqualityandsafety,theirdisposal,destination,orreturntosuppliershallberecorded.

Version5,1April2009

Page26/39


Ensurethat:

Awrittenprocedureonhandlingofincomingmaterialsexists. Incomingmaterialsareregistereduniquelyandinclude:

o Suppliersnameandlot/batchnumber;o Operatorslot/batchnumber;o Nameofmaterial;o Quantityanddateofreceipt;o Possibleexpirydate.

Incomingbulkmaterialsarestoredaccordingtoadequateseparationprocedures. Materialsareinspectedbefore,duringandafterunloading. Theinspectionincludescontamination,pestinfestationanddocumentationoffindings. Nonconformitiesarerecorded. Recordsofinspectionresultsaredocumentedandarchived. Recordsofsupplierguaranteesandotherrelevantsupplierdocumentationkept. Incomingmaterialsarereleasedbeforeuse. Documentationismaintainedincaseaproductisreturnedtothesupplier.

7.5. Productionoffinishedgoods

7.5.1. QualityControlandProduction

The operator shall plan and carry out production and service provision under controlled conditions.Productionareasshallbecontrolledsothataccessfornonauthorisedpersonnelcanbeprevented.

Controlledconditionsshouldinclude,asapplicable:

a) Theavailabilityofinformationthatdescribesthecharacteristicsofthefinishedproduct.

Eachproduct shallhaveawritten specification,which isamendedwhenany changetakesplace.

Eachproductshallhaveauniquenameorcode. Details of packaging and labelling shall be available. Product labelling shall be in

accordancewiththerelevantEUfeedlegislation.

Eachpackageshallbe labelledbyaunique identifier (whichcanbeacombinationofcodes) inorderthatthebatchtowhich itbelongscansubsequentlybe identifiedandtraced.

Allfinishedproductshouldbe inspectedpriortodispatch, inaccordancewithwrittenprocedures,toensureitmeetsspecification.Aretentionsampleofadequatesizeshallbetakenofeachbatchandheld,asaminimum,foratimeequivalenttothedefinedshelflifeoftheproduct.Thesamplesmustbesealedandlabelled,storedinamannerthatshouldpreventabnormalchange,andkeptatthedisposaloftheauthoritiesforaperiodappropriatetotheuse.

Formoredetailed informationonpossiblesamplingproceduresseetheGuidanceonsampling(Annex6).

Version5,1April2009

Page27/39


If products are rejected and thus not put into circulation for any reason related toproduct quality and safety, their disposal, destination, or return to supplier shall berecorded.

b) Theavailabilityofworkinstructions:

Thedifferentstagesofproductionshallbecarriedoutaccordingtowrittenproceduresaimedatdefining,controllingandmonitoring thecriticalpoints in themanufacturingprocess.

Theseshallincludeprocedurestoaddresstheriskofcarryover.c) Rulesgoverningpackaging:

Whereproductsarepackaged,careshallbe taken toavoidcontaminationandcrosscontaminationduringthepackagingprocess,andtoensurethatpackagedproductsarecorrectly identified and labelled in compliance with the provisions of relevant feedRegulations.

Packagingshallbeappropriatetoproducttype,withtheobjectiveofmaintaining thecontentsforitsintendedshelflife.PackagingshallbeconsideredunderHACCPanalysis.

Pallets shall be serviceable, clean and dry. All pallets which are returned after aparticularuseshallbeinspectedandifnecessarycleanedbeforereuse.

d) Rulescontrollingstorage:

Finishedproductsshallbeclearlyidentifiedandstoredincleandryconditions.Accesstothesematerialsshouldberestrictedtoauthorisedpersonnelonly.

Incoming materials, active substances, carrier substances, products which meet thespecificationsand thosewhichdonotshallbestored insuitabledesignedplaces,adapted and maintained, in order to ensure appropriate storage conditions whichmanage the risks of contamination and possible infestation by harmful organisms.Packedmaterialsshallbestoredinappropriatepackaging.

Materialsshouldbestoredinamannerwhichenableseasyidentification,avoidscrosscontaminationandpreventsdeterioration.Astockrotationsystemshouldbeinplace.

The storage environment shouldbe setup in amannerwhichminimises the riskofdamagetopackagingandspillageofmaterial.

e) Rulesconcerningloadinganddelivery:

Productsshallbedeliveredwith,inmind,theprotectionofanimalandhumanhealthasprimeconsiderations.

Containersandequipmentusedforinternaltransport,storage,conveyinghandlingandweighingshallbekeptclean.Cleaningproceduresshouldconsidersuchcontainersandequipment.

Afinalinspectionshalltakeplacetoensuredeliveryofcorrectproduct.

Version5,1April2009

Page28/39


Ensurethat:

Productionareasareaccessibletoauthorizedpersonnelonly; Productionisrunaccordingtoformalproductionplanning; Theproductionplanisdistributedtorelevantpersons; Productionrecordsarekeptprovecompliancewithmasterformula; Crosscontaminationispreventedorcontrolled; Eachproducthasaspecification,uniquenameand/orCode Eachproducthasapredefinedlabel; Finishedproductsareclearlymarkedandidentified; Eachproducthasapredefinedpackaginginstruction; Thepackagingprocessiscontrolledtoavoidcontaminationandmixup; Deliveriesareinspectedpriortodispatch; Thisinspectionisdocumented; Nonconformingproductsaresegregatedandstoredinamannertopreventfailures; Storagefacilitiesareadequatetothepurpose; Storagefacilitiesareoperatedinamannertopreventfailuresduringhandling; Storagefacilitiesaresuitabletothepurpose,e.g.cleanliness,ventilation,dry,andtemperaturecontrolled; Adefinedstockrotationsystemisinplace,e.g.FIFO; Outdatedstockiscontrolledandsegregated; Loosebulkmaterialsarecontrolledandsegregatedfromotherloosebulkmaterial.

7.5.2. Verificationofprocessesforproduction

Theoperatorshallverifyanyprocessesforproductionwheretheresultingoutputcannotbecontrolledbysubsequentmonitoringormeasurement.Thisincludesanyprocesseswheredeficienciesbecomeapparentonlyaftertheproductisinuseorhasbeendelivered.

Verificationshoulddemonstrate theabilityof theseprocesses toachieveexpected results.FrequencyofverificationsshallbeconsideredundertheoperatorsHACCPsystem.Particularattentionshouldbegiventocarryoverandhomogeneity.

Theoperatorshallestablisharrangementsfortheseprocessesincluding:

a) definedcriteriaforreviewandapprovalofthemanufacturingprocesses;

b) approvalofequipment;

c) qualificationofpersonnel;

d) useofspecificmethodsandprocedures;and

e) requirementsforrecords.

Version5,1April2009

Page29/39


Ensurethat:

Awrittenverificationprocedureisinplace; Verificationdatademonstratesallproductionprocessesachieveplannedresults; Verificationdatademonstratescarryoveriscontrolled.

7.5.3. Identificationandtraceability

Toensuretraceability,theoperatorshall:

a) identifyandrecordtheproductbysuitablemeansthroughoutproductrealisation;and

b) maintainaregister,thatcontains:

the names and addresses of manufacturers of incoming materials, additives or ofintermediaries.Incomingmaterialsshallbeverifiedaccordingtosection7.4.2.

thenatureandquantityof theadditivesandpremixesproduced, the respectivedatesofmanufactureand,whereappropriate,thenumberofthebatchorofthespecificportionofproduction in thecaseofcontinuousmanufacturing,and thenameandaddressesof theintermediariesormanufacturersorusers towhom theadditivesorpremixeshavebeendelivered.

Ensurethat:

A traceabilitysystem is inplace, including tracingback from the finalproduct throughqualitycontroldataandbatchrecordstotherawmaterialsusedandthesuppliers;

Deliveriescanbetracedtocustomers,includingcustomername,date,batchandamount.

7.5.4. Preservationofproduct

Theoperatorshallestablishtheshelf lifeofaproductandpreservetheconformityoftheproductduringprocessinganddeliverytotheintendeddestination.

Preservationmeasures shall include product identification, handling, packaging, storage and protection.Preservationshallalsoapplytotheconstituentpartsofaproduct.

Ensurethat:

Astabilityprogramisdefinedandongoing; Productenvironmentiscontrolledduringstoragetopreserveconformancewithqualityandsafetyrequirements.

7.6. Transport

7.6.1. Generalrequirements

Transportationofrawmaterialandfinishedproductsarecriticalpoints intheprocess.Impuritiesthatarehazardous tohumansoranimalsmayget in contactwith the finalproduct.Measuresmustbe taken toensurethatthetransportationofrawmaterialandfinishedproductsisadequateinordertominimizetheriskofcontamination.

Two categories of finished products have to be considered: transportation of packed goods andtransportationofbulkmaterials,eitherliquidorsolid.

Version5,1April2009

Page30/39


Wheredistributionortransport isperformedbyasubcontractor,thetransportershallbeselectedonthebasisthatitcansatisfyproductsafetyandreliabilitycriteria.

The operators HACCP programme shall take transport into consideration when formulating therequirementsonsuppliersandtransporters.

Theoperatormustcommunicateitsrequirementsontransportationtothetransporter;theserequirementsshallbedocumentedandverifiedregularly.

The operators evaluation of the performance of the transporter shall confirm the effectiveness of thetransportersactionstomeettherequirements.

When transport of finished products is arranged with delivery terms and where the buyer takesresponsibility for the transport, it is theoperators responsibility tocommunicate, to thebuyer, that therequirements in this standard will be applied on the transport prior to and on loading andtransportation/delivery.

Ensurethat:

Agreementswithsubcontractedtransportersaredocumented; Selectionoftransporterstakes intoconsiderationtheirabilitytofulfilltheoperatorsrequirementsascertifiedby

thisCode;

Transportersarecontrolled,evaluatedandmeetexpectedqualityandsafetyrequirements; RequirementsinthisCodeareappliedbytheoperatoralsototransportsarrangedbythebuyer.

7.6.2. Transportofpackagedgoods

Feedadditivesorpremixturesshouldnotbetransported,evenifsealed,withgoodsthatcompromisethesafetyoftherawmaterialorthefinishedproduct.

The package for the raw material or the finished product should provide adequate protection againstdeteriorationorcontaminationthatmayoccurduringtransportation.

Ensurethat:

Proceduresareinplacetoensureproductintegrityduringtransport Packagingprovidesadequateprotectionfortherawmaterialorfinshedgoods

7.6.3. Transportofbulkproducts

AsystemshallbeinplacetosafeguardagainstcontaminantswhichmaycompromisetheintegrityoffeedadditivesandpremixturesaccordingtoapplicableexistingRegulations.

Theoperatorshallensure that the transporterofbulkproductshassufficientknowledgeabouthandlingfeedadditivesandpremixtures.Inthebestcase,thisshouldbeprovenbyatransporterscertificationtoarecognizedstandard.

Valid informationabouttheproduct tobe loadedmustbegivenbytheoperatortothetransporter.Thetransportercanthendefinethesuitablecontainertoprovidethebestprotection.

If cleaning of a container is required, the cleaningmethod shall be chosen to best clean any possiblecontaminantsfromthepreviousloads.

Thetransportershallprovidecleaningcertificate(s)withthefollowinginformation:

a) informationthatenablescontainertraceability;

Version5,1April2009

Page31/39


b) previousload(s);

c) methodofcleaning;

d) cleaningcompany;

e) ifapplicable,thecleaneddischargeequipment.

Aftercleaning,theefficiencyofthecleaningoperationmustbecheckedandrecorded.

Exceptionsfromtherequirementoncleanlinessmaybedoneifthepreviousloaddoesnotcompromisethesafetyoftheonetobeloaded.

Formoreinformationaboutcleaning,seeAnnex3Guidanceontransport.

Ensurethat:

ProceduresareinplacetocontrolallrelevantrisksfoundintheoperatorsHACCP; If cleaning is required, the cleaning certificates shall includeall relevant informationneeded toevaluate if the

suppliedcontainerissuitableforloading;

Proceduresareinplacetosafeguardagainstunwantedorforbiddencontaminants.

Version5,1April2009

Page32/39


8 SystemReview8.1. Generalrequirements

TheoperatorshalldocumentmeasurestakentoensurethattheMSisworkingefficiently.Thismayincludeplanning, implementing andmonitoring processes which demonstrate product conformity. Monitoringprocessesshouldincludecollectionofmeasurements,analysisofdata,conclusionsandifrelevant,issuingofprocedureswhichimprovetheMS.

Ensurethat:

Aformalreviewsystemexists; Thesystemincludescollectionofdata; Thesystemincludesanalysisofthedata; Thesystemincludesaconclusion; Thesystemincludesactionsforimprovementoriginatingfromtheconclusion; Timescalesforimprovementsaredefinedandmaintained.

8.2. Internalaudits

Theoperatorshallensurethatinternalauditsareperformedtoverifythatthemanagementsystemis:

a) effectivelyimplementedandmaintained;

b) incompliancewithregulatoryandotherdefinedrequirements;

c) the scope of the audits must be defined and their frequency scheduled in relation to the riskassociatedwiththeactivitytobeaudited;and

d) auditorsshallbetrained,competentandindependent.

Internalauditsmayalsobeusedtoidentifypotentialopportunitiesforimprovements.

Correctiveactionsshallbescheduledandverifiedwhencompleted.

Thescheduleforconductinginternalauditsshallbedocumentedandincludeplanning,reportsanddetailsofsuggestedimprovements.Thedetailedauditprogramshould,asaminimum,include:

a) preparationandissueofauditplans;

b) methodsusedtoconducttheaudits;

c) reportingoffindings;

d) distributionofreports.

Version5,1April2009

Page33/39


Ensurethat:

Ascheduledauditprogramisinplace; Internalauditsarecarriedout; Thescopeofauditsisdefined; Feedsafetyissuesareincludedinthescope; Thefrequencyofauditsisdefined; Theauditorsaresuitablytrained; Auditsandnonconformitiesarereportedanddocumented; Reportsaredistributedtokeystaff; Aformalfollowupisreported; Correctednonconformitiesareverified.

Version5,1April2009

Page34/39


9 Controlofnonconformingproducts9.1. Generalrequirements

Theoperatorshallestablishadocumentedprocedurefordealingwithproductswhichdonotcomplywithintendedrequirements.

Theprocedureshouldinclude:

a) identificationofproductandbatchcode;

b) documentationofanynonconformance,correctiveaction(s)andverificationsteps;

c) evaluationofthecauseofthenonconformance;

d) segregationofaffectedbatchorbatches;

e) provisionfordisposalofproductswhereappropriate;

f) recordingofinternalinformationofrelevantparties.

Responsibilityforreviewanddisposalofthenonconformingproductshallbedefined.

Anonconformingproductshouldbereviewedinaccordancewithdocumentedproceduresandactionedinoneofthefollowingways:

a) rework;

b) reclassificationordispensation;or

c) rejectionandsubsequentdestructionordisposal.

d) Records of all nonconformances must be maintained in accordance with document controlproceduresandarchivedforanappropriatetime.

Theapprovalanduseofreworks(e.g.fromrejects,customerreturnsorspillage)shallbeconsideredwithintheHACCPsystem.Potentialreworkswhicharenotapprovedbecomewastematerialandshouldbedealtwithaccordingtowastedisposalprocedures.

Version5,1April2009

Page35/39


Ensurethat:

Aformalsystemonhowtohandlenonconformingproductsexists. Theprocedurecovers:

o Productidentification;o Documentationofnonconformities;o Evaluationofrootcauses;o Documentationofcorrectiveactionsandverificationsteps;o Segregation,handlingandassessmentofnonconformingproduct,including:

Rejectedmaterials Acceptedmaterialswithrestrictions Justificationofpotentialalternativeusewithinfeedsafetyrequirements

Thestaffisawareoftheseprocedures. Aclearmarkingorothermeansofcontrollingnonconformingproductsexists. Recordsofnonconformitiesaremaintained.

9.2. Complainthandlingsystem

Aformaliseddocumentedprocedureoncomplainthandlingshallexistandshouldincluderequirementsto:

a) allocateresponsibilityforcontrollingcomplaints;

b) recordnameofcomplainingcustomer;

c) recordproductnameandidentificationcode;

d) identifyandrecordeachcomplaint;and

e) replytothecomplainingcustomer.

Correctiveactionsshouldbecarriedoutinatimelyandeffectivemanner,withconsiderationgiventothefrequencyandseriousnessofcomplaints.

Where possible, complaint information shall be used to avoid recurrence and implement ongoingimprovements.

FormoredetailedinformationonhowacomplainthandlingsystemcanbeimplementedseetheGuidanceontheimplementationofacomplainthandlingsystem(Annex2).

Version5,1April2009

Page36/39


Ensurethat:

Aformalcustomercomplainthandlingsystemexists. Responsibilityforcontrollingcomplaintsisdefined. Thesystemincludessufficientcustomerandproductinformation. Thecomplaintsareevaluatedaccordingto:

o Cause;o Seriousness;o Customer;o Otherrelevanttopics.

Thecomplainttopicsareusedtopreventreoccurrence. Therelatedcorrectiveactionsarecarriedthrough. Feedbackisgiventothecustomer.

9.3. Recall

A formal recallprocedure shallbedocumented so that customers canbe informed immediatelyof anyirregularitiesthatmaycompromisefeedsafety.Therecallprocedureshallberegularlyreviewedtoensureconformancewiththequalitymanualandregulatoryrequirementsandtheoperatorsorganization.

Therecallprocedureshouldincluderequirementsto:

a) defineandallocateresponsibilityfortherecallprocess;

b) identifyeachbatchofnonconformingproductincludingconsequencestootherproductbatchesorrawmaterialsthroughouttheentireprocess.

c) identifythedestinationofaffectedbatches;

d) notifycustomersofaffectedbatchesandcoordinateproductreturn;

e) describeproceduresforthehandlingandreassessmentand/ordisposalofrecalledproduct(s)includingsegregationfromotherproductsandmaterials;

f) maintainrecordsofproductrecall(s)andcomponentsfromproductionand/ordistributiontotheaffectedcustomers;

Simultaneouslywiththeabovelistedactionpoints,itisimportanttolimitrecurrenceby:

- ensuringimmediatecorrectiveandpreventiveactionsareundertaken;

- verifyingthatcorrectiveandpreventativeactionsareeffective.

Feed additive andpremixturebusinessesmay also removeproducts from themarket for reasonsotherthanfoodsafety;thesecasesshouldbehandledinthesamemannerdescribedhere.

The recall procedure shall be tested at least annually to ensure functionality. Such tests shall bedocumentedandevaluatedforimprovements.

Version5,1April2009

Page37/39


Ensurethat:

Aformalrecallprocedureexists; Responsibilityisassignedtoanappropriateperson; Therecallprocessisadequatelydescribed; Therecallprocedureincludeshandling,reassessmentand/ordisposalofrecalledproduct; Effectivecorrectiveandpreventiveactionsareimplemented; Anyrecallisrecorded; Therecallprocedureistestedregularly; Thetestrecallsaredocumented; Theoutcomesofthetestrecallsareevaluated.

9.4. CrisisManagement

Ifafeedbusinessoperatorconsidersorhasreasontobelievethatafeedwhichithasimported,produced,processed,manufacturedordistributeddoesnotsatisfythefeedsafetyrequirementsitshallimmediatelyinitiateprocedures to recall the feed inquestion from themarketand inform thecompetentauthoritiesthereof.

o Thecrisismanagementprocedureshallbedocumentedo Responsibilityshallbedefinedfornotifyingcustomersandregulatoryauthoritieso Responsibilitywithintheoperationforproductrecall(s)shallbedefined

ItisimportanttoemphasizethatacrisismayresultinaRapidAlertsituationororiginatefromsuch.

SeeAnnex9 (Guidanceonproduct recallandcrisismanagement) foramoredetaileddescriptionof theprocess.

Ensurethat:

Acrisismanagementprocedureexists; Responsibilityfornotifyingcustomersandregulatoryauthoritiesisdefined; Responsibilityforconductionaproductrecallisdefined.

Version5,1April2009

Page38/39


10 StatisticaltechniquesTheoperatorshall,whereappropriate,evaluateandidentifytheneedfortheuseofstatisticaltechniques.

Wherestatisticaltechniquesareapplied,theneedforthesetechniquesshallbedemonstrated.

Theadequacyofthesetechniquesshallbedemonstrated:

standarderrorshallbecalculatedanddocumented; standarderrormustbeofanappropriateleveltosufficientlyensurefeedsafety; dataexceedingstandarderrorandtrendsshallbemonitored; correctiveactionsshallbespecifiedintheeventofabreechoferrorlimits.

Ensurethat:

Theuseofstatisticaltechniqueshasbeenevaluatedanddefined; Anoverviewofeachstatisticalmethodisavailable; Theapplicabilityofmethodsisdocumented; Theoperatorpossessesthenecessarystatisticalcompetencies.

Version5,1April2009

Page39/39

1 Introduction2 Scope3 Terms and definitions4 Management System (MS)4.1. General requirements4.2. Management principles4.3. General documentation requirements

5 Management Responsibility5.1. Management commitment5.2. Quality and safety policy5.3. Responsibility, authority and communication5.4. Management representative5.5. Management review

6 Resource management6.1. Provision of resources6.2. Human resources6.2.1. Competence, awareness and training6.2.2. Personal Hygiene

6.3. Infrastructure6.3.1. Basic requirements6.3.2. Requirements for facilities, production areas and equipment6.3.2.1. Facilities & production Areas 6.3.2.2. Equipment

6.4. Maintenance and control of monitoring and measuring devices6.5. Cleaning6.6. Pest control6.7. Waste control

7 Product realisation7.1. Product requirements7.1.1. Determination of requirements related to the product7.1.2. Compliance of the product to the requirements7.1.3. Customer communication

7.2. HACCP Program7.3. Design and development7.3.1. Development of new products and processes7.3.2. Change control

7.4. Handling of incoming materials7.4.1. Sourcing of incoming materials7.4.2. Verification of incoming materials

7.5. Production of finished goods7.5.1. Quality Control and Production7.5.2. Verification of processes for production7.5.3. Identification and traceability7.5.4. Preservation of product

7.6. Transport7.6.1. General requirements7.6.2. Transport of packaged goods7.6.3. Transport of bulk products

8 System Review8.1. General requirements8.2. Internal audits

9 Control of non-conforming products9.1. General requirements 9.2. Complaint handling system 9.3. Recall 9.4. Crisis Management

10 Statistical techniques

fami qs v5 codeofpractice

Documents

eec andcommission directive

feed hygiene

repealing council directive

account theprinciplesof

interim measures

codeof pdv

annex onhazardanalysis