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Transcript of This document has been created by Kerry Global Supply Quality.

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This document has been created by Kerry Global Supply Quality.

This document has been approved by the VP Global Supply Quality.

This document has been authorized by the Global Food Safety & QHSE Officer and the Global Chief Procurement & Risk Management Officer.

Kerry Supplier Requirements Manual is effective as of May 2021.

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Contents

Introduction 5

A Quality Management System (QMS) 71. Management Commitment 82. Document and Record Control System 83. Regulatory Compliance 94. SystemVerification/InternalAudits 105. CustomerComplaintsProcedure 106. ManagementofSeriousIssues 117. Training Programme 118. Food Safety Culture 12

B Food Safety Management System (FSMS) 13 1. FoodSafetySystem–HACCP 141.1 HACCPProgramme 151.2 HACCPTeam 151.3 Product Description 151.4 Flow Diagram 161.5 Principle1:HazardAnalysis 161.6 Principle 2: Critical Control Points (CCPs) Identification 161.7 Principle3:CriticalLimitsIdentification 161.8 Principle 4: CCP Monitoring 171.9 Principle5:CorrectiveActions 171.10 Principle6:VerificationProcedures 171.11 Principle 7: Record-keeping 171.12 MonitoringAdherencetothePlan 181.13 HACCPReview 181.14 HACCPInternalAudit 18

2. Good Manufacturing Practices (GMP) 192.1 GMPprogramme 202.2 Hand-washingFacilities 212.3 GMPProgrammeAdherence 212.4 StaffandVisitorHealthAssessment 222.5 Waste Management 222.6 GMPInspections 232.7 Laundry 23

3. Facility, Grounds and Operations 243.1 Grounds and Building Exterior 253.2 BuildingInterior 253.3 Equipment and Utensils 263.4 Hygienic Zoning 263.5 Preventive Maintenance 283.6 Corrective Maintenance 293.7 Walkways, Permanent Ladders and Conveyors 293.8 StaffFacilities 293.9 VehiclesandMovingEquipment 303.10 ContainerLabelling 30

4. Receiving, Storage and Distribution 314.1 ReceptionofIncomingMaterials 324.2 MaterialsandPackagingIdentification 334.3 Raw Materials and Packaging Storage 334.4 StorageofFinishedGoods 344.5 TransportInspectionandVerification 344.6 SupplierApprovalProgramme 37

5. Good Laboratory Practices (GLP) and Testing Programme 395.1 GLPProgramme 405.2 Testing Programmes and Procedures 415.3 In-housePathogenTesting 415.4 Third-partylaboratories 41

6. Cleaning and Sanitation 426.1 Master Sanitation Programme 436.2 UseofCleaningChemicals 436.3 CleaningChemicalsDocumentation 446.4 Pre-operationalSanitationInspection 446.5 Environmental Monitoring Programme 456.6 Cleaning Equipment Storage 46

7. Pest Management Programme 477.1 Pest Control Programme 487.2 Pesticides 48

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7.3 InspectionReports 497.4 Pest-control Devices 497.5 Pest-activityTrendAnalysis 507.6 PestActivity 50

8. Product Control 518.1 Temperature Control 528.2 Contamination Control 528.3 AllergenControl 558.4 SensitiveProducts,ClaimsandChainof

Custody 568.5 Water Contamination 568.6 Control of Non-conforming Product 578.7 FinishedProductRelease 578.8 Operations Control 578.9 Quantity Control 588.10 CalibrationProgramme 58

9. Food Fraud 599.1 FoodFraudDocument 609.2 DocumentAssessment 609.3 Claims 609.4 TestingProcedure 609.5 AssessmentReviewandChangeManagement 60

10. Food Defence and Security Programme 6110.1 FoodSecurityProgramme 6210.2 FoodSecurityProgrammeReview 62

11. Traceability and Product Recall 6311.1 TraceabilityProcedure 6411.2 TraceabilityCodingandIdentification 6411.3 Product Recall Programme 6511.4 Mock Recall 6511.5 Traceability(ChainofCustody)Verification Programme 66

12. Shelf-life of product Delivered to Kerry 6712.1 Shelf-lifeofFoodproductDeliveredtoKerry 68

13. Certificate of Analysis for Product Delivered to Kerry 6913.1 CertificateofAnalysisRequirements 70

14. Sustainability or Corporate Social Responsibility 71

Glossary 77

Annex 83AnnexI:SupplierCodeofConduct 84AnnexII:CertificateofAnalysis(CoA)Requirements 86AnnexIII:GMPgeneralrequirements 90AnnexIV:Communicablediseases 93AnnexV:Environmentaltesting 95AnnexVI:Palletconfiguration 98AnnexVII:Sanitationverificationparameters 100AnnexVIII:Formulasformassbalancecalculation 102

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SUPPLIER REQUIREMENTS MANUAL | KERRY GROUP | 5

Thisdocument,theKerryGroupSupplierRequirementsManual(SRM),outlinesKerry’srequirementsofitssuppliersofrawmaterials(ingredientsandpackaging)andprovidersofoutsourcedprocessesorservicessuchasthird-partymanufacturers.

Itisbasedon,andinlinewith,therecognizedschemesofGlobalFoodSafetyInitiatives(GFSI)1, and conforms to good manufacturing standards and regulations.

AsacurrentorpotentialsuppliertotheKerryGroup,itisyourresponsibilitytomeettheserequirementsatalltimes,andtoupdatealltheappropriateverificationdocumentationatleastannually.

Theseareessentialrequirementstoassurefoodsafety,fooddefence,chainofcustody(seeGlossary)andcompliancewithregulations.TheyarenotintendedtoalteroreliminateanyrequirementsthatmaybesetforthinanycontractsorproductspecificationsissuedbyanyKerryGroupbusinessunit.TheserequirementstaketheplaceofanygeneralsupplierrequirementspreviouslyissuedbyunitsoftheKerryGroupandarecommonthroughoutalloftheKerryGroup.Byreference,theserequirementsbecomepartofourpurchasingcontracts.

KerrymaymodifytheSRM2documentfromtimetotime.Itisyourresponsibilityasasuppliertoperiodicallycheckthatyouhavethemostup-to-dateversion.Pleaserefertokerrygroup.cominordertoconfirmthatyouhavetheup-to-dateversion.

Thedocumenthasthreemainsections: > SectionA:QualityManagementSystem(QMS)

> Section B: Food Safety Management System (FSMS)

> SectionC:Sustainability/CorporateSocialResponsibility(CSR)

ThesethreesectionsoutlinewhatKerryexpectsandrequiresofitssuppliers.

SectionAhas8sub-sections,from‘ManagementCommitment’to‘FoodSafetyCulture’.

SectionBhas13sub-sections: > FoodSafetySystem–HACCP

> Good Manufacturing Practices (GMP)

> Facility, Grounds and Operations

> Receiving,StorageandDistribution

> GoodLaboratoryPractices(GLP)&TestingProgramme

> Cleaning&Sanitation

> Pest Management Programme

> Product Control

> Food Fraud

> Food Defence and Security Programme

> TraceabilityandProductRecall

> Shelf-LifeofProductDeliveredtoKerry

> CertificateofAnalysisforProductDeliveredtoKerry

SectionChas12sub-sections,from‘BusinessConductsStandards’to‘Environment’.

TheremainderofthedocumentconsistsofaGlossary,andAnnexItoAnnexVIII.

Introduction

1 These include hazard analysis and critical control points (HACCP), threat analysis critical control points (TACCP), and vulnerability assessment and critical control points (VACCP). 2 This document is Supplier Requirements Manual May 2021 v1.1

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DefinitionsofNon-conformanceKerrydefinesnon-conformanceasthenon-fulfilmentofarequirementspecifiedintheKerrystandard.ANon-conformancecanbecategorizedasminor,majororcriticalnon-conformance.

Thetermclausebelowreferstoanyseparateclauseorparagraphinthismanual,typicallyoutliningasinglerequirement.

Minornon-conformance:Thisiswhenaclausehasnotbeenfullymetbutthefoodsafetyriskisminimal.

Majornon-conformance:Thisiswherethereisasubstantialfailuretomeettherequirements,orsignificantevidencethatraisesdoubtaboutproductconformity.Itimplieshighfoodsafetyriskortheineffectivenessofarequired system.

Criticalnon-conformance:Thisiswherethereisacriticalfailuretocomplywithafoodsafetyorlegalissuethatposes an imminent risk.

Timeperiods:Alltimeperiodsmentionedinthedocument–suchas“inanappropriatetimeframe”–refertothespecifictimeperiodgiventothesuppliertoclosethenon-conformances.

* Disclaimer: Both Kerry’s and third-party-nominated auditors will use their professional judgement when applying the acceptance criteria in a holistic manner, taking into consideration factors such as the nature of the product, further mitigation processes, and intended use.

Further requirements not detailed in this document may apply according to the nature of the product and the facilities being audited. The auditor will apply both judgement and experience.

Note: To return to the List of Contents at any stage, click on ‘List of Contents’ in the footer of the page.

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AQuality Management System

(QMS)

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1. Management CommitmentSummary:Managementshowscommitmenttofoodsafetyandqualityinquantifiableways,includingadocumented policy, a food safety and quality manual, provision of adequate resources, and support for continuing improvement of food safety culture.

Requirements > Thecompanyhasadocumentedpolicystatingitsintentionstomeetitsobligationtoproducesafeand

legalproducts,andtocomplywithitscustomerrequirements.

> Thecompany’sprocessesandproceduresaredocumentedinafood-safetyandqualitymanualtoenableconsistency and training, and to support due diligence.

> Site senior management attend management review meetings.

> Managementreviewmeetingsincludereviewdate&frequency,managementreviewrepresentativename,review agenda (e.g. review of food safety policy) and capital plan to support food safety initiatives.

> Managementprovidestheresources(humanandfinancial)neededtoproducefoodsafely,incompliancewiththelawandKerry’srequirements.

> Managementenablesandensuresthatnon-conformancesraisedduringKerry’sauditareaddressedassoonasisreasonablypossible.

> ManagementensuresthatcompanystaffcollaborateandallowKerry’sauditorstoverifytheiradherencetotheagreedstandard.

> SupplyChainmanagementisaccountableandresponsibleforcommunicatingKerrysupply-chainqualitystandards.TheStandardandProcedureisprovidedtoeverydivisionaldirectorandqualitymanagerforimplementationatthesitelevel.

> Suppliersofingredients,foodproductsandfoodpackagingitemsmustnotifytheKerryGroupofanychangethatmayaffectthequalityorintegrityoftheproducts.

2. Document and Record Control SystemSummary:Adocumentcontrolprocedureshallbeestablishedthatdefinesthecreation,control,retention,reviewandobsolescenceofallfoodsafetyandqualitydocumentsandrecords,suchasprocesses,procedures,formulasandspecifications.Recordsshallbemaintainedforallfoodsafetyandqualityrecordstoprovideevidenceoflegalityandconformitytoproductsafetyandqualityrequirements.Allnecessarydocumentsneededtodemonstratethequalitymanagementinplacemustbecurrent.

Requirements > Thecompanyshalloperateadocumentandrecordcontrolsystemtoensurethatthecorrectversionsofall

documentsareusedintheplant.

> Documentsandrecords,notlimitedtothefollowing,shallbecreatedaspartofthecontrolsystem:– Policies

– Manuals, including Quality and Food Safety manuals

– Specificationsandformulas

– Standard operational procedures (SOPs)

– Formsandchecklists

– Supportingdocumentsneededtodemonstratethatthesupplychainisunderstrictcontrol

> Recordsshallbeclear,unambiguousanddetailedasrequired.

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> Recordsshallbecontrolled,retainedandstoredappropriately,allowingretrievalwithoutunduedelay.

> DocumentsandrecordscontainingKerryIntellectualProperty(IP)shallbecontrolledandmaintainedinasecured environment.

3. Regulatory ComplianceSummary:Suppliersshallcomplywithalllawsandregulationsthatapplytofoodproductsandpackaging.Adocumentedprocedureshallbemaintained.

Requirements > Suppliersshallcomplywithalllawsandregulationsthatapplytofoodproductswheretheyare

manufactured and delivered.

> Inrelationtothelawthatappliestospecificfoodproductsandtheirpackaging,thesuppliershallmaintainadocumentedprocedurecoveringthefollowing:– Listofrelevantregulationsinthecountrywheretheproductsaremanufactured

– Listofrelevantregulationsinthecountrieswheretheproductsareusedorconsumed

– Theappointmentofpersonnelresponsibleforupdates

– Anoutlineofthemethodusedtoensurelistsofregulationsarekeptuptodate

> Evidenceoflocalregistrationorapproval,whichcoversalltheactivitiesonsite,shallbeavailable.

> SpecificationsofthefoodproductsandpackagingsuppliedtoKerryshallbecommunicatedandagreedwithKerryandtoprovideafoundationforinspectionandapproval.

> SupplierstoKerryshallberesponsibleforcompletingKerry’sRawMaterialQuestionnaire(RMQ)fornewitems.Thiswillfacilitatethecreationofrawmaterialspecificationsandenableotherregulatoryrequirements.TheCertificateofAnalysis(COA)istobeprovidedtoKerryinaccordancewiththerequirementsoutlinedinAnnexII.

> WhereKerryrawmaterialspecificationsareprovided,theyformpartofthebuyingcontract.Inthiscontract,itisclearlyindicatedthatthesupplieracknowledgesandunderstandsthespecifications;thesupplieragreestoallowanaudittobeperformedbeforethestartofsupply,andagreestocomplywithspecifications.Theappropriatethird-partyverificationdocumentationmustbeprovidedaspartofthespecificationagreement.

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4. SystemVerification/InternalAuditsSummary:Thecompanyshalloperateaninternalauditingprogrammethroughwhichitcanverifythatthequalityandfoodsafetyplanisbeingoperatedeffectively.

Requirements > Thecompanyshallimplementaninternalauditingprogrammethatcoversallsectionsofthefoodsafety

management system.

> Throughthissystem,thesuppliershallverifythatthequalityandfoodsafetyplanisbeingoperatedeffectively.– Theprogrammeincludestheareastobeauditedandthefrequencyoftheaudits.

– Every area is audited at least once annually.

– Externalresourcesmaybeusedforinternalauditing(e.g.consultantorsubcontractedexperts).

– Evidenceisgatheredtoshowthatanyrequiredcorrectiveactionshavebeenimplementedandverified.

– Allinternalauditorsaretrained:theleadauditorrequiresformaltraining;theleadauditormaytraintheotherauditors,usingsupportingtoolssuchaschecklists.

– Anauditorneverauditshisorherownwork.

– Non-conformancesidentifiedintheinternalauditsareaddressedwithappropriatecorrectiveactionstopreventreoccurrences.Thesecorrectiveandpreventiveactions(CAPAs),alongwithverificationoftheirefficiency,arecompletedassoonasisreasonablypossible.

5. Customer Complaints ProcedureSummary:Awrittenprogrammeshallbeinplacetoensureeffectiveresponsetocustomercomplaintsandconcerns,andtominimizethenumberofrecurringcomplaints.

Requirements > Awrittencustomercomplaintsprogrammeshallbeinplacetoreceiveandinvestigatecustomer

complaints,andenablethefacilitytorespondtocustomerconcerns.

> Customercomplaintsshouldbehandledeffectively.Theinformationassembledshouldbeusedtoreducethelevelofrecurringcomplaints.– Thecomplaintsprogrammeincludesaclearlydefinedmethodofdistributingcomplaintstothe

relevant departments to ensure immediate response, especially in cases involving food safety issues.

– Allcomplaintsreceivedarerecordedandinvestigated,andtheirrootcauseisidentified.

– Actionsappropriatetotheseriousnessandfrequencyofthecomplaintaretakenpromptlyandeffectively.

– Thecomplaintdataisanalyzed,andusedtoimplementongoingimprovementtoavoidrecurrenceofcomplaints.

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6. ManagementofSeriousIssuesSummary:Thecompanyshallhaveadocumentedmanagementplantoeffectivelymanagethreatstofoodsafety, legality or quality.

Requirements > ThecompanyshallhaveadocumentedSeriousIssuesManagementPlantoeffectivelymanageincidents

andemergencysituationsthatmightaffectfoodsafety,legalityorquality.

> Theplanshouldincludedetailedmeasuresonhowtomanage:– Disruption of key services

– Fire,floodornaturaldisaster

– Malicious contamination

– Disease pandemic

> Alistofkeystaffandkeyexternalcontacts(governmentinspectors,keycustomers,certificationbodies,etc)shallbedrawnupandshallbekeptuptodate.

7. Training ProgrammeSummary:Thecompanyshallhaveadocumentedtrainingprogramme,whichincludesdetailsofthetypeandfrequencyoftrainingforallstaff.

Requirements > Thecompanyshallhaveadocumentedtrainingprogramme,whichcoversinductiontraining(fornewand

temporarystaff),foodsafety,GMPandpersonalhygiene,sitesecurityandrelevantSOPs.

> Allstaff,includingtemporarystaff,shallbetrainedatapredeterminedfrequency.

> TheprogrammeshallincludespecifictrainingforemployeesinvolvedinFSMSsuchasGMPandpersonalhygiene,HACCPPlan,allergenmanagement,foodfraudvulnerabilityassessment,foodsafetyculture,etc.

> Emergingissuesinthemarketshallbeconsideredintrainingprogramme.

> AnyemployeeresponsibleformonitoringCCPshallreceiveCCPtrainingbeforestartingtoworkattheCCPworkstation.

> UponcompletingtheirtrainingforCCPmonitoring,employeesshallbeawareofthefollowing:– Whatiss/hemonitoring?

– Whatisthecriticallimit?

– Whatactionistobetakenincaseofcriticallimitdeviation?

– Trainingforqualifyingsanitizingcrewshallinclude:– Topicscovered,whoconductedthetraining,andexitcriteriausedtoverifyskillrequirements– Jobskills,jobsafety(i.e.safechemicalhandling,emergencyresponseandfoodsafety)– Cleaningassignmentsbasedonskillqualification– Keepingofcurrenttrainingrecordsandrecordingofon-the-jobtraining

> Ifacontractproductioncleaningcompanyisappointedforcarryingoutthesanitationprogramme,theappointedcompanymustmaintaincopiesofthetrainingrecordsoftheirentiresanitationcrewatthesupplier’ssite.Theirtrainingprogrammemustcovertheaforementionedprogramme.

> Anytrainingcarriedoutshallberecordedappropriately.

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> Recordsofalltrainingthathastakenplaceshallbekept,includingadescriptionofalltheinformationconveyedinthetrainingsessions.

> Trainingeffectivenessshouldbeverifiedanddocumented.Verificationmaybeintheformofanexam,observationandcommentsbythedirectmanager,etc.

8. Food Safety CultureSummary:Aclearplansupportingthedevelopmentandcontinuingimprovementofthefoodsafetyandqualitycultureshallbeestablishedandmaintained.

RequirementsThedocumentedfoodsafetycultureplanshallinclude:

> Definedactivitiesinvolvingallsectionsofthesitethathaveanimpactonproductsafety.

> Anactionplanindicatinghowtheactivitieswillbeundertakenandmeasured,andtheintendedtimescales.

> Areviewoftheeffectivenessofcompletedactivities.

> Examplesofrelevantactivitiesthatcouldbeincorporatedintothefoodsafetyculturedevelopmentplan,butarenotlimitedto:

– Trainingreviewandstaffdevelopment– Annualstaffreviewsandrecognitionprogrammes– Employee surveys on company values and culture– Teamworkthatpromotesengagementandreinforcesfoodsafetypractice(e.g.staffinvolvementin

settingproductsafetyobjectives)

– Effectivecommunicationstrategies(e.g.townhallmeeting,relevantGMP&foodsafetyposters,KPIsposters to promote employee engagement)

– Confidentialfeedbackandreportingsystemenablingemployeestoreport/shareconcernsrelatingtoproductsafety,integrityandquality.Thefeedbackandreportingmechanismisclearlycommunicatedtothestaff.

– Proactivitytochange,innovationorinvestmentinfoodsafetyandqualityculture

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BFood Safety Management

System (FSMS)

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1FoodSafetySystem(HACCP)

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1. FoodSafetySystem–HACCP1.1 HACCP ProgrammeSummary:AdocumentedHazardAnalysisandCriticalControlPoints(HACCP)systemshallbeestablishedandsignedbyseniormanagement.

Requirements > Adocumented,effectiveHACCPplanshallbeestablished..

> TheHACCPplanshallcovertheCodexAlimentariusHACCPprinciples.

> TheHACCPplanshallincludefoodsafetypolicyandobjectives,andshallbeendorsedbyseniormanagement..

1.2 HACCP TeamSummary:AmultidisciplinaryHACCPteamshallbeestablishedandteammembersshallbeformallytrained.

Requirements > TheHACCPteamshallincludepersonnelfromanappropriaterangeofdisciplines–i.e.quality/technical,

production,engineeringandotherrelevantfunctions.

> Theteamleadershallbeappropriatelytrained,haveundergoneformaltrainingontheHACCPsystem,andbequalifiedtoleadtheHACCPteam.Arecordofformaltrainingshallbeavailable.

> TherestoftheteamshallhaveHACCPtraining,eitherinternallybytheteamleaderorexternally.Theirtrainingrecordsshallbeavailable.

> TheHACCPplanshalldocumenteachteammember’sspecificknowledgeofHACCPandrelevantknowledgeofproduct,processandassociatedhazards.

> Ifthecompanylacksappropriatein-houseknowledge,externalexpertisemaybeused.However,day-to-daymanagementoftheHACCPprogrammeremainstheresponsibilityofthecompany.

1.3 Product DescriptionSummary:Productdescriptionandintendeduseshallincludeallrelevantinformationonfoodsafety..

Requirements > Thedescriptionshallincludeataminimum::

– Raw materials and ingredients (including origin of)

– Importantproductcharacteristics–i.e.biological,chemicalandphysical

– Storage condition

– Shelf-life

– Packaging type

– Methodofdistribution

– Intendeduseandintendedconsumers

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1.4 Flow DiagramSummary:Aprocessflowdiagramorchartshallbecreatedforeachproduct.

Requirements > Aprocessflowdiagramorchartforeachproductshallbecreated,coveringallaspectsofthefoodprocess

operationwithintheHACCPscope,fromreceivingrawmaterialstoprocessing,reworks,packing,storageanddistribution.

> Thechartshallbedated,signedandverifiedasaccurate.

1.5 Principle 1: Hazard AnalysisSummary:Hazardanalysisandriskassessmentshallbecarriedoutforeachrawmaterialandprocessstep,including control measures.

Requirements > Hazardanalysisandriskassessmentshallbeconductedforallrawmaterialsandprocesssteps,toidentify

significantfoodsafetyhazardsandmeasurestocontrolthesehazards.

> Thehazardanalysisandriskassessmentshallbebasedonscientificortechnicaldata,andshallcoverspecifichazardsrelevanttoproductsandprocesses,includingallergencross-contaminationwhereapplicable.

– Thehazardanalysisshallanalyzemicrobiological,physical,chemical(includingradiological)andintrinsichazards.Generally,intrinsichazardsareallergens,butthesemaybeconsideredaschemical.Still,itisimportanttorecognizethatallergenshavebeenconsideredinthehazardanalysis.Forbiologicalhazards,notonlygenericbutspecificmicro-organismsofconcernfortheproductmustbedetailed(e.g.inthecaseofeggs,analyzetheriskofnotonlypathogensbutalsoofsalmonella).

– Considerationshallalsobegiventotheformofthehazardthatpresentsthebiologicalhazard(whethervegetativecell,sporeortoxin)..

1.6 Principle2:CriticalControlPoints(CCPs)IdentificationSummary:Allstepsshallberigorouslyreviewedtoidentifycriticalcontrolpoints..

Requirements > Everystepshallbereviewedtoidentifythosepointsthatarecritical.Alogicalapproachisrequired.For

example,usingaCCPdecisiontreecanhelp.

CCPsarethecontrolpointsrequiredinordertoprevent,eliminateorreducetoanacceptablelevelthehazardsidentified.

1.7 Principle3:CriticalLimitsIdentificationSummary:Criticallimitsshallbeidentifiedandshallbevalidatedscientifically.

Requirements > AnappropriatecriticallimitshallbeestablishedforeveryCCPinordertospecifyclearlywhetherthe

processisincontroloroutofcontrol.Thecriticallimitshouldbe:

– Measurablewhereverpossible–time,temperature,pH,etc

– Supportedbyclearguidanceorexamplewherethemeasuresaresubjective–e.g.byuseofphotographs

– Scientificallyestablishedandvalidated–e.g.throughtesting,byscientificorlegalreference(bibliography)

> Theperformanceobjectiveofallprocessesortechnologiesusedtoeliminateortargetpathogenicorganismsshallbedefinedandvalidated.

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The performance objective is the number of logarithmic reduction for the pathogen of concern; for example, peanut processors in the Americas must validate their thermal process/roasting to ensure they are able to achieve a five-log reduction of salmonella.

> FormicrobiologicalCCP,revalidationisrequiredforanychangestotheprocessorproductrangethatmayaffectfoodsafety.

1.8 Principle 4: CCP MonitoringSummary:ACCPmonitoringprocedureshallensurecompliancewiththecriticallimits.

Requirements > AmonitoringprocedureshallbeestablishedforeachCCPtoensurecompliancewiththecriticallimit.The

monitoringprocedurecandetectprocessesoutofcontrolofCCP.Itcovers:

– Whattomonitor:

– Frequencies– Personnelresponsibleforthemonitoring– Personnelresponsiblefordealingwithnon-conformances.

1.9 Principle 5: Corrective ActionsSummary:Correctiveactionsshallbeestablishedincaseofdeviationincriticallimit.

Requirements > AppropriatecorrectiveactionsforeachCCPshallbeestablished.Theseshalldescribeallstepsneededto

identify,quantifyandsegregateaffectedproductswhenmonitoredresultsindicatelossofcontrolorfailureto meet critical limit.

> Recordsofcorrectiveactiontakenwhencriticallimitsarenotmetshallbemaintained.

1.10 Principle6:VerificationProceduresSummary:VerificationproceduresshallbeestablishedtoconfirmthattheHACCPplaniseffective.

Requirements > VerificationproceduresshallbeestablishedtoconfirmthattheHACCPplan,includingthecontrols

managedbytheprerequisiteprogrammes,iseffective.

> Examplesofverificationactivitiesare(thelistisnotexhaustive):

– Reviewofrecords:CCPrecords,IPQCrecords,etc

– SigningofCCPrecordsbyanauthorizedpersoncapableofverifyingthatthepersonundertakingthecheckhasbeenproperlytrainedandhascompletedtherecordscorrectly

– Internalaudits

– Reviewofcomplaintsornon-conformancesraisedbyanenforcementauthorityorcustomers

– Reviewofincidentssuchasproductwithdrawalorrecall

> Recordsofrelatedverificationactivitiesshallbemaintained.

1.11 Principle 7: Record-keepingSummary:Recordsshallbekeptofmonitoring,deviationandverificationactivities.

Requirements > Recordsshallbekeptofmonitoring,deviationandverificationactivities.Thesearesufficientto

demonstrateandtoenablethecompanytoverifythattheHACCPcontrolsareinplaceandmaintained.

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Theserecordsarewellmaintainedandlegible.

> Recordsassociatedwithmonitoringshouldinclude,asaminimum:

– Date– Time – Resultofthemeasurement– Signingbythepersonwhoundertookthecheck

> Whererecordsarerecordedelectronically,thereshouldbeevidencethatthesehavebeenmonitoredandverifiedataprescribedfrequency.

1.12 Monitoring Adherence to the PlanSummary:TheCCPsidentifiedshallbemonitored.

Requirements > TheCCPsidentifiedshallbemonitoredaccordingtothemonitoringprocedureestablishedtoensure

compliancewithcriticallimits.

> TherecordsofCCPmonitoringshallbeincompliancewiththemonitoringprocedure(asper1.8‘Principle4:CCPmonitoring’,above).

> Recordsofcorrectiveactiontakenincasesofdeviationofcriticallimitshallbekept.

1.13 HACCP ReviewSummary:AprogrammeforreviewingtheHACCPplanshallbeestablished.

Requirements > AwrittenprogrammeforreviewingtheHACCPplanshallbeinplace.

> Areviewshallbecarriedoutatleastannually,orwhenevertherearechangessuchasequipment,processes, products or ingredients.

> TheHACCPteamshallcarryouttheHACCPreview.Itisacceptabletoseekconsultationorexternalhelp.

> Areviewshallbecarriedoutwhenthereis:

– Changeinrawmaterialorsupplierofrawmaterial

– Changeiningredientsorrecipe

– Changeinprocessingconditionorequipment

– Changeinpackaging,storageordistributionconditions

– Changeinconsumeruse

– Emergence new risk – e.g. adulteration of an ingredient

– Developmentinscientificinformationthatrelatestoingredients,processorproducts,orachangeinregulatory requirements

> Theresultsofthereviewshallbedocumentedandrecorded.Arevisionhistoryshallbemaintained.

1.14 HACCP Internal AuditSummary:HACCPverificationshallbecarriedouttoconfirmtheefficiencyandsuitabilityoftheplan.

Requirements > HACCPverification(internalaudit)shallbecarriedoutatleastannually–preferablybeforetheannual

HACCPreview–sothatresultscanbefedintothereviewforconsideration.

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2Good Manufacturing Practices

(GMP)

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2. Good Manufacturing Practices (GMP)2.1 GMP ProgrammeSummary:AGMPprogrammeshallbeestablished.

Requirements > AwrittenGMPprogramme,whichappliestoallemployees,visitorsandcontractors,shallbeestablished.It

coversthefollowing:

> TheGMPprocedureshallcoverappropriatedresscodeandpersonalhygiene:

– Outergarmentspolicy:personnelwhoworkindirectcontactwithfood,foodcontactsurfacesorfoodpacking materials must:

– Wearcleanoutergarmentstocoverstreetclothingwhileworking– Wearprotectivecoveringswherebareskinmaycomeincontactwithexposedfoodorfoodcontact

surfaces (e.g. arm sleeve covering)– Removeprotectivegarmentswhenleavingaworkstation(e.g.whengoingtotherestroom,goingfor

abreak,goingoutsidethebuilding),andputtheprotectivegarmentsbackonwhenre-enteringtheworkstation

– Userestraintsforhairandbeard(includingmoustache),unlessclean-shavedortrimmednearskin.

– Do’sanddon’tsinsidemanufacturingarea:

– Nogum-chewing– No eating– No smoking– Nojewelleryorwristwatches,includingexposedbodyjewellery(piercing)– Restrictiononmake-up(seeAnnexIII),falseeyelashes,long/falsefingernails,bodyglitter,strong

perfumes, etc Exceptions: Items worn for medical or religious purposes and plain wedding bands are allowed as long as the company has a daily control in place to monitor.

– Thehand-washingprocedureisadequatelydefined.

> TheGMPrequirementsshouldbepostedinappropriateGMPzones(includingentrances)foremployees,visitors and contractors to refer to.

> Signagethatdefinespersonalhygienerequirementsapplicabletoemployeesmustbeinalanguageorlanguagesthatemployeescanunderstand.

> AllemployeesshallundergoGMPtrainingatleastannually(seeA7:Trainingprogramme)..

> Thecriteriaforpre-employmentmedicalscreeningshallbeclearlydefined(differentcountrieshavedifferentlegislationrequirements).Acommunicablediseasepolicy,includingmanagementofopenlesions,shallbeimplemented.Personnelhealthcardsshallbecurrent.

> Workgarmentsmustnothavebuttonsorexternalpocketsatwaistlevelorabove.

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2.2 Hand-washing FacilitiesSummary:Adequatehand-washingfacilitiesshallbeprovided.

Requirements > Theemployershallprovideadequatehand-washingfacilitiesinallrestrooms,atproductionentrancesand

inhigh-riskareas,toinclude:

– Hands-free operation – i.e. foot pedals, knee pedals or automated– Dryingdevice–i.e.disposablehandpapertowel– Antibacterialandunscentedliquidhandsoapspecificallydesignedforthefoodindustry– Handdisinfectantspecificforthefoodindustry–useofbleachisstrictlyprohibited– Asufficientquantityofpotable(drinkingquality)wateratasuitabletemperature– Binsthatdonotrequirelidstobeopenedbyhand

> Hand-washsinksshallbeusedforhand-washonly,andnotforotheruse.Papertoweldispensersshouldnotrequirehandstotouchthedispenserfortowelretrieval.Clothtowelsofanysortarenotacceptable.

2.3 GMP Programme AdherenceSummary:Allemployees,visitorsandcontractorsshallcomplywiththeGMPrequirements.

Requirements > Employees,visitorsandcontractorsshallcomplywith:

– theoutergarmentpolicy– thehand-washingprocedure– thedo’sanddon’tsinsidethemanufacturingarea

> Personalitemsshallbestoredawayfromprocessingareas–e.g.caps,coats/jackets,radios,fans,etc

> Anyemployeewithanopenlesionoranyotherabnormalsourceofmicrobialcontaminationshallbeexcludedfromanyoperation.Bandagesarecoveredwithanon-porouscoveringsuchaslatexorplasticgloves.

> Hand-washsignsshouldbeposted,asappropriate.

> Toolsandprocessingsupplies(includingcleaningtoolsandsupplies)shallbeproperlystoredwhennotinuse.

> Areasshallbekeptfreeofcluttertoenableworkerstoperformtheirdutiesefficiently.

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2.4 StaffandVisitorHealthAssessmentSummary:AllvisitorsshallhaveahealthassessmentsignedbeforeenteringtheplantandhavebeentrainedinGMP requirements.

Requirements > Anypersonenteringtheplant(speciallycontrolledareas)shallhaveahealthassessmentcarriedout

beforehand:

– Allstaff(permanentortemporary)havehadahealthassessmentcarriedoutinadvance,statingtheirsuitabilitytoworkincontactwithfood.Thisassessmentispreferablyrenewedannually.

– Allvisitorssignahealthassessmentinwhichtheirsuitabilitytoaccesstheplanthasbeenevaluated.Thereviewandauthorizationtoentertheplantaredocumentedtoo.

See Annex IV: Communicable Diseases

> Ifthevisitor/contractorisfrequentlyon-site,anannualrecordmaybesufficientprovidedcompletionofyearly training is recorded.

> A‘backtoworkaftersickness’procedureshallbeinplace.

2.5 Waste Management Summary:Awastemanagementprogrammeshallbeimplemented.

Requirements > Wastecontainersshallbeidentified(e.g.colour-codedorlabelled)andwaste(e.g.paper,plastic,

biodegradable)shallbecollectedandstoredinappropriatecontainersandshallbedifferentfromthoseused for food products.

> Anadequatenumberofwastecontainersshallbeavailableinthemanufacturingfacilityandbekeptingood repair.

> Wastecontainersshallbeemptieddailyataminimum.

> Whenremovedfromproductionandstorageareas,wasteshallbekeptindesignatedwastecontainers,shallbecovered,andshouldnotattractpests.

> Substandard,trademarkedmaterialsshouldbedestroyed(arenotreusable),preferablybyaspecialistthirdparty,toensuretheydonotreturntothefoodchaineitherbychanceorbecauseoffraud.

> Recordsthatstatethequantityofwastecollectedanddisposedofshallbeavailable.

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2.6 GMP InspectionsSummary:Self-auditonGMPelementsshallbeconductedatleastquarterly.Afacilityinspectionprogrammeshallbeestablishedatapredeterminedfrequencybasedonriskassessment.Auditresultsandcorrectiveactionstakenshallbeavailableonfile.

Requirements > Aself-auditonGMPelementsshallbeconductedatleastquarterlytocheckforanydeviationfromthe

required standards.

> Theself-auditGMPchecklistshallcoverallelementsspecifiedintheGMPprogramme.

> Facilitiesinspectionprogramestablishedshallincludeproductionareas,non-productionareasandsurroundinggroundswithdefined

– Frequency of inspection.

– Personnelresponsibleforconductingtheinspections(maybeindividualorgroup).– Checklistofareasinspected.

> Anycorrectiveactionsneededshallbetakenandtheirstatusshallberecorded.

> Arecordoftheauditresultsandofanycorrectiveactions–includingtheirstatus,verificationoftheireffectiveness,andtheircompletion–shallbeavailableonfile.

2.7 Laundry Summary:Aneffectivelaundryprogrammeorsubcontractedlaundryserviceshallbeinplace.

Requirements > Launderingcanbesourcedouttoanapprovedlaundryprovider.Anin-houselaundryisacceptableif

criteriatovalidatetheeffectivenessofthelaunderingprocessaredefined,anditseffectivenessisverifiedaccordingly:

– Ifoutsourced:– Nameandcontactdetailsoftheappointedcontractor– Methodofdeliveringcleanedgarments–i.e.useofcoversofbags– Contractor’son-siteinspectionandreportmaintained

In-houselaundry:– Thelaundryproceduredefinesthemethodofdirty-garmentcollection,washinganddrying,the

methodofdeliveringcleanedgarments,andthepersonnelresponsible.– Washingofprotectiveclothingbyemployeesisacceptablewhereitisworninlow-riskareasor

wheretheproductisinanenclosedsystem.

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3Facility, Grounds and Operations

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3. Facility, Grounds and Operations3.1 Grounds and Building ExteriorSummary:Theplantgroundsandbuildingexteriorshallbeadequatelymaintainedsoastoprotectagainstpests,andavoidcontaminationoffoodorofthefacility..

Requirements > Groundsandbuildingexterior:

– Theplant’sexteriorperimeters(roads,yards,grounds,parkinglots)shallbemaintainedingoodcondition.Theareasarecleanandlitter-free.

– Theareawithintheimmediatevicinityofthebuilding(asareference:6metres/20feet)shouldbefreefromweeds,tallgrassoranyidleequipment.Thisistopreventharbourageofpests.

– Idleequipmentandpipesshallbestoredoutsidethe6-metre(20-foot)area,inacleanandorganizedcondition,andatleast15cm(6inches)abovethegroundtopreventrodent/pestbreedingandharbourage.Pipeendsshallbesealed.

– Areasshallbefreefromstandingorpoolingwaterthatcanserveasasourceofcontaminationandbreedingplaceforpestsorinsects.Thereisadequatedrainage.

– Loadingdocksshallbefreefromdebrisandspilledproducts.Anyitemsorequipmentstoredinthisareamustbecleanandarrangedinanorganizedway.

– Thebuildingshallbepest-proof.Anyopeningsorgaps(e.g.gapsunderdoors)aresealedorscreened adequately.

– Doorsandwindowsshallbeclosedatalltimes.

– Cracksandcrevicesshallbesealed

> Neighbouringactivitiesmustnotposeanyriskofproductcontaminationorcompromiselegalstatus,suchasHalal,KosherorGMO-free.

3.2 Building InteriorSummary:Theinteriorsofbuildingsshallbedesigned,constructedandmaintainedsoastofacilitateGMP.Interiorhousekeepingshallbemaintainedtoensurecleanliness.Allareasshallbeproperlymaintainedtoprevent product contamination.

Requirements > Wallsandceilingsshallbeconstructedwithmaterialsthatpermiteasycleaning,andbekeptingood

repair:

– Thewallsandceilingsarenotconstructedofwood.– Anycracks,crevicesorotheropeningsaresealed.– Floorsaresmooth,cleanable,non-slipandadequatelyslopedtodrains.– Thereisnoevidenceofcondensationonceilingsorwalls,orofstandingorpooledwateronfloors..

– Walls,floors,drainsandceilingsarecleanandfreefromanybuild-upofoldanddustycobwebs..

> Thereshallbeadequatelightinginallareasofthemanufacturingfacility:receiving,processing,storage,packing,shipping,locker-rooms,restrooms,breakareas,etc.

> Nooverflowingwastecontainersandnooffensiveodoursshallbeevident.Anyspillageshallbepromptlycleaned up.

> Agediceorfrostbuild-upinfreezers,andmouldormildewinchillersorcoolersshallnotbeevident.

> Aislesandworkspacesbetweenprocessingequipmentshallbekeptunobstructedandofadequatewidthtoallowemployeestoperformtheirdutiesandprotectagainstcontamination.

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> Adequateventilationshallbemadeavailable.Theventilationunits,suchasfansandairconditioners,shallbeproperlymaintainedandkeptcleantominimizethepotentialforcontaminatingfoodproducts,packagingmaterialsandotherprocessingequipment.

> Extractorfansandcanopiesshallbeprovidedinareaswherecookingoperationsarecarriedoutoralargeamount of steam is generated.

3.3 Equipment and UtensilsSummary:Equipmentandutensilsshallbedesignedandconstructedsoastopreventcontaminationoffoodproducts.

Requirements > Equipmentandutensilsshallbesystematicallyverified.Thelifecycleofeachutensilshouldbeidentified

foreachapplication.

> Woodenequipmentandwoodenfoodsurfacesarenotusedinfoodprocessingareas.Onlyflour-millprocessingequipment–suchaspurifiers,siftercomponentsincludingboxesandsieves,roll-standcabinet,etc–areexemptedfromthe‘nowood’requirement,aslongasthewoodusedisingoodconditionandlacks any cracks or splinters.

> Equipmentandutensilsshallbekeptingoodrepair.Theyshallbefreefromrust,notbrokenanddonothaveanypiecesthatmayfallintoaproduct.

> Mouldorrustshouldnotbeevidentonequipment.Contactsurfacesshallbecorrosionresistant.

> Equipmentshallbeconstructedfromfood-gradematerials–e.g.food-gradestainlesssteel(304/316).Beltshaveafood-gradestatementprovidedbytheirsupplier.

> Equipmentshallbeusedforthetaskitisintendedfor.

> Equipmentshallbeplacedsoastoallowenoughroomforcleaningandmaintenance.

> Equipmentandfoodcontactsurfacesshallhavesmoothseamstoavoidproductresiduesorthegrowthofmicro-organisms.

> Equipmentandutensilsshallbeingoodcondition,cleaned,driedandstoredappropriately.

3.4 Hygienic ZoningSummary:Thehygieniczoningprogrammeshallbedesignedanddocumentedtoreducethepotentialforcross-contamination of materials and products.

Requirements > High-careandhigh-riskzonesshallbephysicallysegregatedorseparated.

> Thesuppliershallcarryoutariskassessmenttoidentifypotentialsourcesofcross-contaminationbetweenprocessingareasand/orproducts(e.g.producthandlingareas,storageareas,processingareas,rawmaterials),anddocumentthefindings.

> Theoutcomeoftheriskassessmentshallbedocumentedinasiteplanofthefacility.Thesiteplanshouldindicate:

– Accesspointsandtravelroutesforpersonnel:employeesarenotallowedtomovefreelyfromlow-risk/low-carezonestohigh-risk/high-carezones(orviceversa)unlesstheychangeoutergarmentstoavoid any risk of cross-contamination.

– Locationofstafffacilitiesandroutestothefacilitiesfromplacesofwork:thelocationoftransferpoints must not compromise segregation or pose any risk of contamination. Materials and packaging transfershouldinvolveadisinfectionprocessifnecessary.

– Productionprocessflow(rawmaterials,workinprocess,packaging,finishedproduct)

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– Routes for removal of waste– Routesforthemovementofrework– High-risk/high-carezonesandhygienejunctions:itisrecommendedthatareaswhereuseofwoodis

bannedbealsoindicatedinthesiteplan.

> High-riskzonesshallbesuppliedwithsufficientchangeoffilteredair(seeAnnexV:EnvironmentalTesting–‘Airqualityrequired’).

> Thefollowingitemsshallbedocumented:

– Specificationoffilterused– Frequencyoffilterchange– Theriskassessment– Minimumairchangesrequiredperhour– Airqualitystandard(seeAnnexV:EnvironmentalTesting–‘Airqualityrequired’)

Zonesdefinition > Non-manufacturing zone: Low-care

– Thereisnoopenproductinthiszone.– Productmaybestoredbutnotmanufacturedhere.– Thiszonemayincludeoffices,cafeteria,locker-room,laboratory,utilitiesroom,etc.

> Low-risk zone

– Thiszoneincludesareasforreceivingandstoringrawmaterialsthathavebeenpotentiallycontaminatedandrequirecontrolstopreventcontaminationofhigher-hygienezones.

– Theseareasmayhavededicatedemployeesandmaybephysicallyseparatedfromcontrolledorhigh-control zones.

> Controlledzone:High-care

– Productthatisnothighlysensitivecanbeexposedtotheenvironmentandtheoperators.– GMP practices are implemented. – Thecontrolledzonemayalsoserveasatransitionfromnon-manufacturingandhigh-riskzonesto

high-controlzones.– Productsofhighersensitivitymaybepresentiftheyarecompletelyenclosed.

> High-controlzone:High-risk

– Productofhighsensitivitycanbeexposedtotheenvironmentand/ortheoperators.– AdditionalGMPpractices,suchascaptivefootwearandclothing,shouldbenecessary,andmore

stringentequipmentandbuildingsanitarydesignrequirementsshouldbeapplied.

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Examples of production zones

Product Low-Risk Zone High-Care Zone High-Risk Zone

Milkprocessing/dairy plant

Raw milk receiving Processing area after pasteurization

Cold-filledarea

Peanut and tree nuts processing

Raw nut receiving and handling

Processingandfillingafterkillstep

n/a

IQFvegetables Rawvegetablereceivingarea

Processing/packingaftermicrobialreductionstep(e.g.finalrinse,validatedblanching)

n/a

Spices Spice receiving Processingandfillingafterkillstep

n/a

RTE meat Raw meat receiving and handling

Processing after kill step Packing area

3.5 Preventive MaintenanceSummary:AwrittenPreventiveMaintenanceprogrammeshallbeestablishedtoensureproperpreventivemaintenanceofallequipmentandofrelevantareasofthefacility.

Requirements > ThePreventiveMaintenanceprogrammeshouldinclude:

– Aproceduretoensurethepropercleaningandsanitizingofequipmentaftermaintenanceactivity,beforeitisusedinproductprocessing

– Notificationtosanitationcrewbyproductionpersonneloftheneedforcleaningandsanitizingaftermaintenance work is completed

– Aprocedureforreconcilingpartsandtoolsaftermaintenanceisperformed.Allpartsandtoolsmustbeaccountedfor(bycheckingagainstalisttoensureallpartsandtoolsarereconciled)

– Verificationandsign-offbydesignatedpersonnel(operationsstaff,productionstafforqualitystafftakingtheresponsibilityfrommaintenancestaff)thatfoodcontactzoneshavebeenclearedofanypartsandtoolsbeforebeingreleasedtoproduction.Managementmustbenotifiedimmediatelyifanyparts,toolsorpiecesofequipmentarefoundtobemissing.Correctiveaction(s)aredocumented.Nolooseorunaccounted-forpartsortoolsarefoundintheprocessingareas.

– Aproceduretoprotectexposedandnon-exposedproductsduringmaintenanceactivitiesisdocumented.

– Guidelinesmustbeinplacetoremoveproductsknowntohavebeencontaminatedbyanymissingpartsortools,topreventtheirentranceintothefinalproduct.

– Recordsthatmustbeavailabletoreview:– Recordsofequipmentpartsandtoolsreconciliationchecklistfollowingmaintenanceactivities

(beforeandafter)– Recordsofnotificationtosanitationcrewofcleaningandsanitizingrequiredaftermaintenance

work is completed– Recordsoffoodcontactzonesthathavebeencleanedandsanitizedbeforebeingreleasedto

production– Records of corrective actions (if any).

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3.6 Corrective MaintenanceSummary:Equipmentandstructurerepairsshallbeproperlycompleted.

Requirements > Thecorrectivemaintenancesystemmustensure:

– Allequipmentandstructuresareproperlymaintained.– Equipmentrepairsormodificationsareprofessionallycompletedwithouttheuseofstring,tape,wire

orotherimprovisedmaterials.– Shouldtemporaryrepairberequiredtocompletetheshift’sproductionrun,thetemporaryrepair

doesnotposeanyrisktofoodsafety.Permanentrepairshouldbecompletedwithinonemonthorasearlyaspossible.

– Ifarepairmustbecompletedduringproductiontime,preventivemeasuresaretakentopreventproduct contamination (e.g. use of screens). .

3.7 Walkways, Permanent Ladders and ConveyorsSummary:Allwalkways,permanentladdersandconveyorsoverexposedproductsoropenbinsoringredientsshallbeshieldedtoprotectproductandpackingmaterialsfrompossiblecontamination.

Requirements > Atleast10cm(4-inch)kickplatesshouldbeusedtoshieldwalkwaysandladdersoverproductconveying

beltsoropenbinsofingredients,topreventdirtorforeignmatterfromfallingontofoodorfoodcontactsurfaces, or into packing materials.

> Plantrefrigerationunits–includinghigh-velocityair-conditioningunits(HVACs)shallhavecatchpansforcondensate control.

> Electricmotorslocatedoverexposedproductshallbeshielded.

> Nocondensateshallbeobserveddrippingontofoodorfoodcontactareas.

3.8 StaffFacilitiesSummary:Breakareas,locker-rooms,restroomsandwashstationsshallbemaintainedinacleanandsanitarycondition.

Requirements > Allareasarekeptclean,withnorubbishorspillageresidue,andmouldshallnotbeevidentonwalls,

ceilingsandfloors.

> Breakareasshallbeseparatedfromprocessingareas,andemployeesshallcomplywiththeouter-garmentpolicy.

> Brought-to-workmealsshallnotbekeptinlockers.Temperature-controlledrefrigerationunitsandreheatingunitsshallbeprovided.

> Drainsfunctionproperlyandshallbefreeofstandingwater.

> Hand-washingstationslocatedatbreakareasandinrestroomsshallbesufficientlystockedwithantibacterialliquidhandsoap,waterofasuitabletemperature,papertowels,ahandsanitizer,andarubbishbin.

> Nooffensiveodoursshallbepresent.

> Women’srestroomsshallhavecoveredsanitaryreceptacles.

> Lockersandstorageinthelocker-roommustallowstreetclothingandpersonalbelongingstobecompletelysegregatedfromworkclothesandshoes.

> Properventilationshallbeavailable,androomsshallbeequippedwithself-closingdoors.

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3.9 Vehicles and Moving EquipmentSummary:Vehiclesandequipment–usedformovingrawmaterials,finishedproductsandpackagingmaterialssuchasforklifts–shallbekeptcleanandmaintainedingoodcondition.

Requirements > Forkliftsusedinsideandoutsideofthefacilitiesshouldnotposeanyriskofcontamination.

> Forkliftsshallbewellmaintained.Batteriesshallbeproperlystored

> Storageandchargingstationsshallbelocatedawayfromfoodproductsandpackagingmaterials(atleast2m/6feetaway)andmaintainedinacleancondition.

> Noleakingbatteriesorotherfluidsshallbepresent.

> Accessforpest-controlmonitoringshallbemadeavailablebehindbatterystorageareas.

> Gasoline-(petrol)ordiesel-poweredforkliftsshallnotbeusedindoors.

3.10 Container LabellingSummary:Allcontainersinthemanufacturingfacilityshallbeproperlylabelled.

Requirements > Allcontainersformanufacturinguse,includingwastecontainersandspraybottles,shallbeproperlyand

legiblylabelled,andshallspecifytheintendedcontents.

> Wherecolour-codingisusedforidentification,adequatesignageshallbepostedinrelevantareas,indicatingthecolour-codinginterpretation.Kerrypreferscolour-coding,butacceptsanyothersystemiffullidentificationispossibleandthereisnoriskofmistakes.

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4Receiving, Storage and

Distribution

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4. Receiving,StorageandDistributionSummary:Receiving,storageanddistributionmethodsshallbeusedtoprotectfoodfromcontaminationthroughfoodsafetyhazards,pestsorobjectionablesubstances.

4.1 Reception of Incoming MaterialsSummary:Awrittenprocedureonthereceivingofincomingmaterialsshallbeestablished.

Requirements Theprogrammeforthereceptionofincomingmaterialshallinclude:

> Definedproceduresoninspectionanddocumentationofincomingrawmaterials(ingredientsandpackaging materials).

– Allofthetruck,sealingandpackagingintegritymustbeinspectedanddocumented.– Thepersonnelresponsibleforinspectionmustbeidentified.– Thecriteriaforinspectingthedeliveryvehicleandloadmustbedefined:cleanliness,signsofpest

infestation,temperature,physicalcondition,quality,tamperevidence,off-odours,etc.

> Labellingofpackedincomingrawmaterialsshouldincludethefollowing:

– Supplier details (name, address, contact details, supplier manufacturing site address, etc)– Product (name and code)– Quantity– Lot code– Dates(manufacturing,shelflife)

> VerificationofcompliancewithspecificationeitherbyCertificateofAnalysis(CoA)furnishedbythesupplierforeachbatchofmaterialorbyconductinginternaltestingforkeyattributesuponreceiptofeverybatch

> Whichevermethodisused,compliancewiththeagreedspecificationmustbedeterminedpriortoarrivalandrelease.SpecialcareisgivenasregardsGMO,Kosher,HalalorAllergenscompliancedeclarations.

> Incomingmaterialsamplingplan,frequencyandtestingmethods(thisispartoftherawmaterialtestingprogramme)

> Minimumlifeonreceipt(MLOR)–apercentageoftheoriginalshelf-lifeavailableattheendofmanufacture

– Localproducts–75%ofmanufactureshelf-life– Internationalproduct–50%ofmanufactureshelf-life

> Thereshouldbeateamresponsibleforcarryingoutacomplianceverificationcheckuponreceivingofrawmaterials,andthatdecidesdispositionbyacceptingorrejecting,andraisingnon-conformance(NC)incaseof deviation.

Requirements:

– Anysensitivematerialautomaticallygoesonholdandrequiresthemanager,ordesignate,torevieweachCertificateofAnalysis(CoA)orapplicableverificationdocumentationpriortouse.

– Parcelshipment:anyshipmentreceivedisplacedinthequarantineareauntilverificationdocumentationhasbeenreceived,reviewedandaccepted.MaterialwillnotbeplacedintoinventoryuntiltheacceptedCoAisonfile.

– Procedureforproduct‘onhold’:thisisarequiredmethodtopreventreleasepriortoverificationofcompliancewithapprovedspecification.

– Procurementand/orrelevantstakeholdersmustbenotifiedofallshipmentswithouttheappropriateverificationdocumentation.

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– AnyCoAisverifiedagainstthepackingslipandbilloflading(BL)formaterialdetailse.g.materialname,materialcode,batchnumber,productiondate,etc.

– VerificationisneededtoensurethatanyCoAmatchesthespecificationsforbothtestsandresults.– Sensoryandlaboratoryanalysismustbecarriedout,whenapplicable.– Dairyrawmaterialsmustoriginatefromnon-FMD(foot-and-mouthdisease)andapprovedcountries

only,andappropriateverificationdocumentationand,wherelegislatedfor,veterinarycertificatesmustbeprovided.

> Appropriatecontrolshouldbeinplaceifingredientsarereceivedinbulk(suchasbytanker,rail,etc).Atransferprocedureisinplacetoprotectproductfromcontamination;hosesareclean,cappedandstoredabovetheground,andconnectionportsintothebuildingarecappedandlockedwhennotinuse.

> Allliquidbulkrawmaterialsarefilteredwithaninlinefilterstrainer.

> TheCertificateofAnalysis(CoA)mustaccompanyeachloadifitisusedforspecificationcompliance.

> Contactpackagingmusthaveafoodcontactcertificate,MaterialSafetyDataSheet(MSDS)andmigrationtestresultsforthetypeofmaterialtobepackedin;e.g.migrationsfrompackagingtoproductmayvarydependingonwhethertheproductissolid,liquid,oil,colourants,flavours,etc.

4.2 MaterialsandPackagingIdentificationSummary:Rawmaterialsandpackagingmaterialsshallbeidentifiedandclearlylabelled.

Requirements > Allrawmaterialsandpackagingmaterialsareidentifiedandclearlylabelled.

> Thereceivingdateisrecorded,orthereisaverifiablesysteminplacethatensures‘firstinfirstout’(FIFO)or‘firstexpiredfirstout’(FEFO)productrotation.

> Ingredientsandprimarypackagingaretraceablebythesupplier’slotnumberorbytheprocessingfacility’sassigned system.

4.3 Raw Materials and Packaging StorageSummary:Allmaterials(includingWIP,intermediateproductsandrework)shallbekeptincleanstorageareasandaccordingtotheproduct’sstoragerequirement.

Requirements > Allrawmaterials(includingpackaging,WIP,intermediateproductsandrework)storedshallbeingood

condition – intact, clean, protected and free from contamination or spoilage.

> Allmaterialsshallbecoveredtopreventcontamination.

> Allmaterialsshallbestoredinappropriatestorageconditionsandatthecorrecttemperature,accordingtomanufacturerinstructions,whichgenerallyareasfollows:

– Drystorage:ambienttemperature– Freezer:minus18C(0.4F)andbelow

– Chiller:0C(32F)to4C(39F)

> Anyproductonholdforspecificationcomplianceverificationthatisrejectedduetodamagedpackage,isoutofspecification,outofshelf-lifeordoesnotconforminquality,etc,shallbeproperlysegregated,clearlyidentifiedandlabelled,andheldinappropriatecondition.

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> Storageareasshallbekeptinacleanandsanitarycondition,withnoevidenceofspillsorotherlitterwithinthefacility.Spillagesshallbeimmediatelycleanedup.

> Aninspectionperimetershallbemaintainedalongallstoragewalls(46cmor18inchesfromthewall)toallowforinspectionofpest-activitycleanliness.Inaddition,materialsarestoredoffthefloor(atminimumof15cmor6inches,orpalletheight).

> Ifaninspectionperimeter(asspecifiedabove)isphysicallyimpossible(e.g.smallstorageroom),theareashallbecleanedandinspectedatleastmonthly,andtheinspectionisrecorded..

> Part-usedingredientsorpackagingshallbekeptcleanandprotectedagainstdustandotherformsofcontamination.

4.4 Storage of Finished GoodsSummary:Thereshallbeaprocedureforadequatemanagementandcontroloffinishedproductduringstorageanddispatch(FIFO,expiredproductcontrolandFEFO).

Requirements > Aprocedureshallbesetuptoensurethatfinishedproductisadequatelymanagedandcontrolledduring

storageanddispatch,toavoidanyproductsafetyrisk,orqualityrisk.

> Ataminimum,theprocedureduringfinishedproductstorageshallinclude:

– Temperaturecontrolofstorageareaswhennecessary– Segregationofproductswherenecessarytoavoidcross-contamination– Storingofmaterialsoffthefloor

– Specifichandlingorstackingrequirementstoavoidproductdamage

4.5 TransportInspectionandVerificationSummary:Carriersandtransporters,includingvehicles,shallbeinspectedforloading,palletizing,sealingandtraceabilitytoensurefoodsafety.

VehiclesandtrailersorcontainersdeliveringtoKerryshallbeingoodcondition,roadworthy,compliantwithalllocalregulations,fitforpurpose(e.g.roadtankerscarryingfoodareusedexclusivelyforfood),fittedwithallnecessaryequipmenttoprovidesecurityofvehicle(e.g.lock-ingates,restraints,sealsandothermethods),fullyoperational (refrigeration systems or controlled temperature conditions), clean and sanitary.

Acontract/specificationshallbeagreedwiththecarrierthatdetailstheapplicablefoodsafetyandqualityexpectations and requirements. Carriers are audited as necessary to verify compliance. Carrier performance is scoredbysupplychainandcommunicatedtomanagement.

Requirements > Allvehiclesshallbeinspectedbeforeloading,andtheinspectionisdocumented.Containersshallbe

inspectedinternallyandexternallyforholes,dents,excessiverust,anddamageinsealsorlocks.Theyarefreefromodours,soil,mud,debris,pest,anynon-foodorfooditemthatmaycontaminatetheload(allergen,rawmeat,etc),andanyotherformofcontamination.

> Theinspectionshallinclude:

– Cleanliness – Lackofodoursorotherresidues– No evidence of pests and pest resistance– Suitabilitytoavoiddamagetotheload

– Temperaturecontrolequipmentwhennecessary

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> Ataminimum,theprocedureduringloadingandpalletizingshallinclude::

– Useofcoveredbaysforvehicleloadingandunloading– Securingoftheloadonpalletstoavoidmovementanddamageintransit– Inspectionofloadsandpackagingintegritybeforedistribution– Palletizingisdoneusingslip-sheets,andavoidsanykindofcross-contaminationordamageto

product

> Pallets

– Palletsshallbeingoodconditiontoavoidanyhealthandsafetyorproductcontaminationrisk.Goodpalletizingpracticesareinplacetophysicallysecuretheloadandenableeasyidentification.Thecriteria for wooden pallets are: – Allboardsareintactandsecuredtobearers.– Therearenobrokenboards,missingboards,orprotrudingnails.– Noforeignobjectsarepresent,suchassoil,oil,chemicals,powdersorothercontaminants.

– Palletweight– Toensuresafehandling,transportationandstorage,maximumpalletweightsarespecified(unless

mutuallyagreedotherwise):– 1,250kg(grossweightofpallets,packagingandproduct)

– Palletheight

– Maximumpalletheightissetat:– Unitinthepallet>16kg(andchilled/frozenfood)–1.3m– Unitinthepallet<16kg–1.8m

– Palletconfiguration– TheconfigurationTIxHIisusedforstockcontrolandefficient,safestorage:– Ti=numberofunitsperlayer– Hi=numberoflayers– Thepalletmustbeinterlocked,unlessspecificallyrequirednottobe–inwhichcase,orwhen

columnstackingisunavoidable,itisrecommendedtousecardboardsheetsatinternalsthroughthepallettoimprovestability(seeAnnexVI).

– Palletuseandoverhang– Forsafetyandefficiency,thepalletconfigurationshouldbedesignedtousethewholesurfaceof

thepallet,withoutproductprotrudingoverthepallet.– Underusedoroverhangingpalletspresentariskduringtransportationorstorage,anddonot

allowforsafedouble-stacking.– Wrapping

– Whenwrappingisusedtosecuregoods,itshouldbedoneinasafemanner,withclearstretchfilmthatallowsthegoodstobeseen.Ifairflowneedstobemaintainedtokeepthegoodsinoptimumconditions,perforatedstretchfilmcanbeused.

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Ingeneral,thewrappingshould:– befirmlysecured,notbelooseortrailing,butthetensionshouldnotriskdamagetothegoods– beappliedinasufficientnumberofpassestoholdthegoods– anchortheproducttothepallet,allowingsufficientbindingarea– Palletlabelsmustbeappliedafterthepalletiswrapped..

– Palletlabelling– Palletlabelsmustcontaintheminimuminformation: (a) Supplier details (name, address, contact details, supplier manufacturing site address, etc) (b)Product(nameandcode) (c) Quantity (d) Lot code (e)Dates(manufacturing,shelflife)– Labelsshouldbeprintedonwhite,non-glossy/non-reflectivelabels,befreefromprintingdefects

andbepositionedcorrectly.– Whenbarcodesareused,thosemustbeinhigh-qualityprint,toallowthemtobescanned.Labels

needtobeappliedsmoothly,notwarpedorfoldedover,andqualitystockshouldbeappropriateforthetemperatureenvironment(chilledandfrozenchambers).

– Twolabelsshouldbeappliedperpallet,oneateachforkentryside.Thelabelsshouldbeataheightofbetween40cmand80cm(16and31inches).

– Multi-SKUpallet(consolidationofpallets)– Multiple-partlayerpalletsarenotsafeorefficient.Itisacceptabletoconsolidatedifferentproducts

intoonepalletifthefollowingcriteriaaremet: (a)Alloftheproductshavebeenorderedinless-than-layerquantities. (b)Alloftheproductsarepartofthesamepurchaseorder. (c)Eachoftheproductsoritemsisclearlysegregated,toallowforeasyidentification. (d)Eachproducthasitsown‘pallet’label. (e)Palletsarestretch-wrapped. (f)Nomorethan4productsaretobeconsolidatedinasinglepallet. (g)High-visibilitylabelsareappliedtothefinishedpallet(forkentrysides),indicating‘MixedPallet’’.

– Multi-lot pallets– Consolidatingproduct(2ormorelotnumbersofthesameproduct)intoasinglepalletis

permitted,ifthefollowingrulesareapplied:– Buildthepalletinthecorrectstockrotationorder–withfresherstock(longerexpirydate)atthe

bottomandoldest(shortestexpirydate)atthetop.– Thecombinedquantityofunitsshouldbeindicatedinasinglepalletlabel(notdifferentlabels

fordifferentcodes).– EnsurethattheTIxHIisnotexceeded.– ApplyalabelindicatingMulti-LotPallet.– Ensurethattraceabilityofalldates/lotscanbemaintained.

– Palletslip-sheets,padsandcorners– Useofcardboardslip-sheetsandpalletpadsispermittedandisagoodpractice.Theseslip-sheets

mustbemadeofcardboardorpaperonly.Plastic,woodoranyothermaterialisnotpermitted.Theslip-sheetsmustremainconfinedtothepalletfootprint.

– Cardboardcornerpostsarealsopermittedtoimprovestability,but,sincetheyleadtoextrawaste,theyshouldonlybeusedwhennecessary.

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> Ataminimum,theprocedureforsealingtrucksandcontainersinvolvesinspectiontoensurethatthetruckandcontainerhavebeencorrectlyloadedandsealed,includinginthoseinstanceswhereKerryhasarrangedthefreightandthecarrierisunderaKerrycontract.

> Traceabilityshouldbeensuredduringtransportation.Distributionrecordsdemonstratingsufficientchecksare completed and kept current.

> Thetransportcompanyshouldbeprovidedwithavehiclebreakdownproceduretoensurecorrectproducthandlingshouldanincidentoccur.Evidenceofthisconsistsoftransportcompanysign-offorcontract.Driversign-offisrequiredwheninternaltransportisinvolved.

> Coldchainmanagement

– Theterm‘coldchain’shallcoverallthemeansusedtomaintainthetemperatureoftemperature-sensitiveproductsastheymovethroughthechainofcustody,fromproductiontofinaluser.– Toensurethesafetyandqualityofthetemperature-sensitiveproducts,thesuppliermustensure

thatthecoldchainismaintainedateverypointofthechainofcustody.– Chilledproductshouldnotexceed5Cor41F(avoidingformationofcrystals)atanypointinthe

chainofcustody.– Frozenproductshouldnotexceed-18C(-0.4F)atanypointinthechainofcustody.– Productrejectedduetotemperaturebreachesmustnotberedelivered.– Whendeliveringtemperature-controlledproducts,thevehiclerefrigerationunitmustremain

running until directed to unload. – Theuseofdataloggersisrequiredtoverify,atleastannually,thatthecoldchainisunbroken.

4.6 Supplier Approval ProgrammeSummary:Asupplierapprovalprogrammeshallbeestablishedforallrawmaterialsandpackagingmaterials,clearlydefiningprocessesbywhichasupplierisapproved.

Requirements > Thesuppliershallhaveinplaceawrittensupplierapprovalprogramme,whichshallinclude:

– Acurrentandaccuratelistofapprovedsuppliers– Supplier evaluation and selection criteria

– Asupplierauditprogrammethatincludesthefollowingfoodsafetyelements:– HACCPprogramme– Cleaning&sanitation– Pest control programme– GMP– Process control– Traceabilityandrecall– Food security

> Third-partyauditisacceptable;preferably,GFSIbenchmarkedcertification.

> Thefrequencyofthesupplierperformanceevaluationandsupplierauditshallbedeterminedbasedonproductrisktothefacility.

> Thesupplierperformancecriteriashallinclude:

– Numberofcomplaints– Delivery performance– Specificationcompliance– Correctiveactionswhenissuesareidentified

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– Definedmethodofsuppliermonitoringandtracking

– Criteriafordisqualification

> Inthecaseofagricultural-basedrawmaterials:

– Theuseofpesticidesshallbedocumented,withfulltraceabilityperfield.– Thereshallbeadocumentedandup-to-datelistofpesticidesandfertilizerspermitted,and

documentedproofthatallagriculturalsuppliersareinformedaboutthisrequirement.– Itmustbedemonstratedthatagriculturalsuppliershandleagrochemicalsaccordingtolocal

regulationsandsecurity(includingdoses,harvestintervals,quantityineachapplication).

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5GoodLaboratoryPractices

(GLP) and Testing Programme

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5. GoodLaboratoryPractices(GLP)andTestingProgramme5.1 GLP ProgrammeSummary:AwrittenGLPprogrammeshallbeestablished.Onlyapprovedofficialtestmethodsorestablishedmethodsthathavebeenvalidatedshallbeused.Alltestmethodsshallbedocumented.

* This section is not applicable to a manufacturing site that does not have an in-house laboratory.

Requirements > IfthelaboratoryisISO17025orCLAS(Campden)-certified,itcanbeacceptedascomplyingwiththewhole

section;onlygenerallaboratorypracticesneedtobeverified.Theprogrammeshallincludeorcoverthefollowing:

– Awrittenstandardoperatingprocedureforalltestmethodsused.Approvedofficialtestmethods(e.g.AOAC)arefollowed.

– Handlingandstorageofreagents,media,preparedmediaandchemicals–tobeusedwithintheirshelf-life,labellingofallcontainers(primaryandsecondary)includingdistilledwater,labellingofbottle/containeropeneddate,prepareddateanduse-bydate

– Awrittenprocedureforinternalandexternalcalibration,whichincludescalibrationschedule,methodsandfrequencyofcalibration,identifyingappropriatereferencestandards

– Awrittenprocedureforcontrollingcross-contaminationbetweenlaboratoryandmanufacturingareas(applicableifthelaboratoryistestingforprocedures)

– Assessmentofthecompetencyofthelaboratorytechnician,atleastannually,foreachoftheteststhats/heperforms

– Atrainingprogrammeforalllaboratorystaff,includingsamplingtechnique

> Laboratorycompliance:

– Thelaboratoryhassufficientworkingandstoragespaceandoverallfacilitiestohandleworkload.– Thelaboratoryshallbewellorganized,cleanandfreefromclutter.– Nopersonalitems,foodandbeverageshallbestoredinthelaboratory.Noeating,gum-chewing,

drinkingorsmokingtakesplaceinthelaboratory.– Themicrobiologicalandchemicallaboratoriesshallbesegregated,andmeasuresareinplaceto

avoidcross-contaminationofmicrobiologicallabstaffintoproduction.– Especiallyinmicrobiologicallaboratorieswherepathogensaretested,accesstostaffshallbe

controlled,andentryislimitedtoauthorizedpersonnelonly.– Designatedlaboratorycoatsand/orotherprotectiveclothingforlaboratoryuseshallbewornin

thelaboratory.Microbiologicallabgarmentsareclearlydifferentiatedfromgarmentsworninthechemicalorproductionareas(e.g.redcollar).

– Calibrationresultsshallberecorded.

– Laboratoryresultsshallbedocumentedandsigned.

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5.2 Testing Programmes and ProceduresSummary:Thetestingprogrammesandproceduresdevelopedshallbecomprehensive,andallimportantelementsshallbeincluded.

Requirements > Testingproceduresforthefollowingprogrammes(ifapplicable)shallbeestablished,incorporatingtest

parameters,acceptablelimits,frequency,personnelresponsible,etc:

– RawMaterial,Ingredients,PackagingTestingprogramme:otherthanmicrobialtest,otherparameterstobeconsideredareallergens,GMO,pesticidesandheavymetals.

– FinishedProductTestingprogramme:testingparametersshallincludeallthosestipulatedintheagreedspecifications.

– EnvironmentalTestingprogramme:thisshouldbeuniquetotheproductandproductionenvironment,andincludeswabbingoffoodcontactsurfaces(aftersanitization),ofanyrelevantsurfacesinhigh-careorhigh-riskzones,andworkers’handswab(duringfoodhandling)(seeAnnexV).

– Utilities Testing programme (water, gas, steam and ice)

> Shelf-lifeassessmentsshallbecarriedoutregularly.

> Watertestingshalltakeplaceatleastonceayear,fromdifferentsamplingpoints.Thewateranalysisresultsshallmeetthelocalregulatorystandard.Ataminimum,watershallbeanalyzedfor:

– Total plate count– Coliforms– E coli (not necessary if none detected in coliform count)– Heavy metals: lead and mercury– Off-flavoursandodours

> Retentionsamplesshallbekeptforeverybatchproducedforatleast1.5timestheshelf-lifetimeinordertosetupandverifytheshelf-lifeofproducts.

5.3 In-house Pathogen TestingSummary:Controlmeasuresshallbeestablishedforplantsthattestpathogenson-site.

Requirements > Strictcontrolsshallbeinplace,forbothentriestoandexitfromthelaboratory;e.g.airshower,negativeair

pressureinthelaboratoryandfilteredoutlet,completegarmentchange,showerchange,fullhand-wash,etc.

5.4 Third-party LaboratoriesSummary:Appointedthird-partylaboratoriesthatperformcriticalanalysisshallbeaccredited,andoperateinaccordancewithISO17025orequivalent.

Requirements > Appointedthird-partylaboratoriesthatperformanalysisthatiscriticaltoproductsafetyand/orlegality

shallbeaccredited,andoperateinaccordancewiththerequirementsandprinciplesofISO17025.

> Thescopeofaccreditationshallbeavailable,andshallcoverallthecriticaltestsperformedonproductqualityandsafety(ISO17025certifieseachtest,notthewholelaboratorysystem).

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6Cleaning and Sanitation

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6. Cleaning and Sanitation6.1 Master Sanitation ProgrammeSummary:Awrittenmastersanitationprogrammeshallbeestablishedandallcriticalelementsshallbeadequatelyaddressedtopreventcross-contamination.Thisprogrammeshalllistallequipment,utensilsandareas requiring cleaning and sanitizing.

Requirements > Themastersanitationprogrammeshallspecifythefollowing:

– Allareasandequipmenttobecleaned– Frequencyofcleaningandwhentoinitiatecleaning(e.g.productchangeover,aftereveryshift)– Themethodsandproceduresforeachcleaningtask–theseareadequatelydefinedintheSanitation

Standard Operating Procedure (SSOP)– Thecleaningproductsused,theconcentrationrequired,andinstructionsforuse– Thepersonnelresponsibleforthedesignatedtasks– Theindividualaccountabilityforeachtask,withsigning-offforeachcompletedtask

> Cleaningequipmentandutensilsshallbespecifictoonearea(e.g.rawvs.cooked)orshallbethoroughlycleanedandsanitizedbeforetheyaremovedtoadifferentarea.

> FortheClean-In-Place(CIP)system,thesanitationprogrammeandrecordsshallincludethefollowing:

– Monitoringofallautomaticcleaningsystems,withcleaningchemicalsandconcentrationsdocumented

– ACIPsystemisdefinedby4parameters:– Temperatureofthewaterorsolution– Mechanicalagitation(m/s)– Chemicalconcentration– Circulation time

– Frequencyandmethodtomonitortemperature,flowratesorvelocityinopensystems,andpressureand/orcycletimesinclosedsystems

– ThedosageoftheCIPchemicalisverifiedandrecorded.

– Corrective or follow-up actions are documented.

> Whereexternalserviceprovidersareemployedforcleaninganddisinfection,theyshallfulfilalloftheaboverequirements.

> Recordsandtrendsofthecleaningvalidationreportandtestingrecordssupportingtheeffectivenessofthesanitationprogrammeshallbemaintained.

6.2 Use of Cleaning ChemicalsSummary:Theconcentrationofsanitizerandcleaningchemicalshallbeverified,andcomplieswiththemanufacturer’srecommendedconcentration.

Requirements > Thedilution,concentrationandapplicationofsanitizerandcleaningchemicalusedshallcomplywiththe

manufacturer’srecommendationforeffectivecleaningandsanitation.

> Theautomaticcleaningchemicalmixingstationshallberoutinelycalibrated.Thechemicalconcentrationshallbeverifiedbythesystemsupplier.Aservicereportthatindicatessystemfunctionalityandconcentrationverificationshallbemaintainedonfileandkeptcurrent.

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> Thedilutionofcleaningchemicalaswellasthedilutionandconcentrationofsanitizershallberecorded,signedanddatedeachtimeamanualmixtureismade.

> Toverifytheconcentrationofasanitizingsolution,asampleofalreadymixedsolutionshallbeobtainedandbetestedwithteststripsoratestkit.

> Ifteststripsortestkitarenotmadeavailablebythesupplieratthepointofconcentrationverification,thiswillbeinterpretedas“systematicfailuretousecorrectconcentration”.

6.3 Cleaning Chemicals DocumentationSummary:AMaterialSafetyDataSheet(MSDS)andacopyoflabels,forallcleaningchemicalsandsanitizersused,shallbemaintained.

Requirements > Thelabelsandanyothersupportingdocumentsmuststateclearlythatallcleaningandsanitizing

chemicalsareapprovedforuseinafoodmanufacturingfacility,and/orthattheymeetregulatoryguidelines.

> AcopyoflabelsandtheMSDSshallbekeptonfile,andkeptcurrent,forallcleaningandsanitizingchemicalsinuse.

6.4 Pre-operational Sanitation InspectionSummary:APre-operationalSanitationInspectionprogramme,whichincludesallproduction-relatedareas,shallbeestablished.Recordsofpre-startupinspectionsshallbemaintained.

Requirements > ThePre-operationalSanitationInspectionprogrammeshallbeavailableandshallincludeallproduction-

related areas.

> ThePre-operationalSanitationInspectionprogrammeshallinclude(butnotbelimitedto)thefollowing:

– Thelimitsofacceptableandunacceptablecleaningperformance,basedonthepotentialhazardrelevanttotheproductorprocessingarea(e.g.microbiological,allergen,foreign-bodycontamination,chemicalcontaminationorproduct-to-productcontamination)

– Thelimitsshallbedefinedforbothfoodcontactsurfaceandprocessingequipment.–Acceptablelevelsofcleaningshouldbeverifiedthroughvisualappearancechecking,ATP

bioluminescencetechniques,microbiologicaltesting,allergentestingorchemicaltesting,asappropriate.

– Thesiteshalldefinethecorrectiveactiontobetakenwhenverificationresultsareoutsideoftheacceptablelimits.

– Theresultofthecleaningeffectivenessverificationandanycorrectiveactiontaken,whenverificationsresultsareoutsidetheacceptablelimits,shallberecorded.

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6.5 Environmental Monitoring ProgrammeSummary:AnEnvironmentalMonitoringprogramme(EMP)shallbeestablishedandshallbemonitored.

Requirements > AnEnvironmentalMonitoringprogrammeshallbeestablishedandmonitored.

> RecordsandtrendsoftheEnvironmentalMonitoringprogramme,demonstratingitseffectiveness,shallbemaintainedaspartoftheMasterSanitationprogramme.

> TheEnvironmentalMonitoringprogrammefocusesonspecificpathogens;forexample,Salmonellaspp.andListeriamonocytogenes,usingindicatororganisms(seeAnnexV).

> Theprogrammeshallinclude:

– Asystematicsamplingplantotestallfoodcontactsurfacesonallfood-processingequipment.Theplancoversthefollowingzones:– Zone 1 – direct or indirect product contact surfaces Direct product contact surfaces are surfaces exposed to product during normal equipment

operation. Indirectproductcontactsurfacesaresurfacesfromwhichliquids,dustorothermaterialmaydrain,

drop,diffuseorbedrawnintotheproductorintothecontainer,andothersurfacesthattouchproductcontactsurfacesorthecontainer.

Examplesinclude(butarenotlimitedto):conveyorsurfaces,productchutes,pipelineinteriorandstoragefillhoppers,nozzles,formers,cut&wrapequipment,productscrappers/utensils,productcontactglovedhands,etc.

– Zone 2–non-productcontactsurfacesbutadjacenttoproductcontactsurfaces Suchsurfacesareclosetoproductcontactsurfacesand,undernormaloperatingprocedures,do

notdirectlycontacttheproductortheproductcontactsurfacesofthecontainer,includingtheexterior of processing equipment.

Examplesinclude(butarenotlimitedto):non-productcontactgloves,equipmentsupports,frames,outsideoftunnels,outsideofenclosedfillingcabinetsorbelowfillingequipment,controlpanels,weightscales,motorhousings,catwalks,scrapcarts,HVACvents,vacuumcleanersifusednearproductcontactsurfaces,airfilters,etc.

– Zone 3–non-productcontact;environmentalsurfacesintheprocessingroomthataremoreremote from product contact surfaces

Examplesinclude(butarenotlimitedto):handtrucks,forklifts,walls,drains,floors,equipmentlegs,ductwork,ceilings,forktruckandcartwheels,tools,brooms,squeegees,floorscrubbers,debrisfromvacuumcollectionpoints,floordebris,trashcans,trafficpathwaysintoprocessingarea,ceilingdrainpipes,wall/floorjunctures,washstations,ingredientstorageareas,etc..

– Zone 4 –sitesthatareremotefromproductcontactsurfacesoutsidetheprocessingroombutcouldaffectprocessingareasthroughthemovementofpeople,equipmentormaterials

Examplesinclude(butarenotlimitedto):warehouses,hallways,breakareas,lockerrooms,maintenancerooms,offices,cafeteria,restrooms,coolers,floors,wheeledvehiclesandmaterials,waste/recyclecollectionareas,etc.

– Frequencyofswabandwhentoswab–e.g.afterCIP– Amastersamplingplantodetermineareasforswabbing– Descriptionofmediaandspongesusedforswabbing–e.g.spongewithneutralizingbuffer,cotton

swab– Methodforswabbing,includinghowtohandleswabsoncetaken,howlongbeforeswabsare

processed,howswabsarecollectedspecifictothesizeofareasswabbed– Confirmationmethodifgrowthofindicatororganismispositive– Finalrinsewaterreferencesamples(justbeforeinlet)– Definitionofacceptablecriteriaorstandards

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– Recordingofcorrectiveactionsandfollow-upactions,withplansforretestingifresultsdonotcomplywithstandards

– Methodofinvestigationincaseofpathogenbeingdetected– Procedure for recommissioning a processing room or a piece of equipment– Trainingoftechnicalstaffonswabbingaswellastrainingandqualificationofindividualsoverseeing

theEMP(i.e.microbiologist,foodtechnologistorscience-based);keepingofrecords,andrefreshertraining conducted at least annually

– Recordsaremaintainedandresultsarereviewedandtrendedonaroutinebasistoidentifyareasforcontinuous improvement.

– Wheneverproductsurfacesaretestedforpathogens,theaffectedproductlot(s)isplaced‘onhold’pendingthetestresults.

> Theverificationofthecleaningproceduresmaybevisual(whentheproductcannotsupportmicro-organismsandevidenceofthiscanbeprovided)ormayneedtobedonebasedonallergensresidues(seeAnnexVII:SanitationVerificationParameters).

6.6 Cleaning Equipment StorageSummary:Storageofcleaningequipmentshallbeadequatetopreventcross-contamination.

Requirements > Allcleaningequipmentandchemicalsshallbeneatlystoredandorganized.

> Mopsshallbestoredinadrycondition.

> Allcleaningequipmentshouldbecolour-codedaccordingtoitsdesignatedareaoruse,andstoredinahygienicmanner,offthefloorandsegregatedbydifferentareasoruses.

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7Pest Management Programme

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7. Pest Management Programme7.1 Pest Control ProgrammeSummary:APestControlprogrammeshallbeestablished..

Requirements > AdocumentedPestControlprogrammeshallbeimplemented.Thepest-controlserviceshallbealicensed

andcertifiedPestControlOperator(PCO)oralicensed,insuredandcertifiedPestControlService(PCS).

> APCOwithinthesupplier’sorganizationwhoislicensedandcertifiedshallapplypesticides,oraPCOtraineemayapplypesticidesifauthorizedunderlocallawstodoso.

> Alicenceandcertificatemaybeoneandthesameinsomelocations;therelevantnamemustbeidenticaltothenamesignedonservicereports.

> Ifanon-siteemployeeiscertified,s/hemaysupervisesomeoneelseapplyingpesticides.

> Ineitherscenario,copiesofalldocumentsmustbemaintainedatthefacility.Thelicence,insuranceandcertificationmustbecurrent.

> Theprogrammeshallinclude:

– Designated PCO or designated PCS company.– PCS’sproofofliabilityinsurance.– Updated licence for PCS.– PCOcertification(internalPCOand/orexternalPCO).– Frequencyofscheduledserviceintervals–itisrecommendedthatservicestakeplaceatleast

monthly.– Labellingofallpestcontroldevicessuchastraps,baitstationandinsectlighttraps(insectzappers

thatcausetheinsectstoexplodearenotallowedinsidethefacility)toincludePCOinitialsandinspectiondateonthelabel.

– Masterlistofallapprovedpesticidesusedintheplant,includingwhereandhowtheyareapplied,andconcentration or recommended dilution.

– Up-to-dateschematicmapofallpest-controldevices,showingthelocationoftraps,baitstationsandinsectlighttraps,bothinteriorandexteriorofplant.Thedevicesareidentified–e.g.anumberingsystem – for ease of tracking and trending.

– Explanationofhowunitinspectionswillbetracked.Forexample,thedateandinitialsareonthefinalreportofelectronicscanningofunitsorpunchcards.

– Inproductionandstorageareas,nobaitdevicesareallowed.– Onlyapprovedpestcontroldevicesareplacedinsidethemanufacturingfacility.

– Nofoodbaitsareallowedinternally.

7.2 PesticidesSummary:MaterialSafetyDataSheets(MSDS),handling&mixingproceduresandpesticidelabelsshallbeavailableonfile.

Requirements > Allpesticidesusedshallmeettheapplicableregulationsandapprovals(EPA,USDA,OSHA,etc)andshallbe

approved for use in a food manufacturing facility.

– MSDSforallpesticidesusedshallbereadilyavailableandmaintainedonfile.– Acopyofthelabelforeachpesticide,indicatingthename,mixprocedureandapplicationinstruction,

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shallbemaintainedonfileandkeptcurrent.– Allpesticidesshallbestoredintherecommendedstoragecondition(asspecifiedintheMSDS),ina

locked,securedarea,andshallbeaccessibletoauthorizedpersonnelonly.– Allpesticidesstoredshallbeproperlylabelled.Anysecondarybottleorcontainershallbelabelled‘for

insecticideuseonly’.

– Pest-controlchemicalsshallbeusedintheiroriginalpackaging,andcontainersshallnotbereused.

7.3 Inspection ReportsSummary:Servicereportsorpest-controlinspectionrecordsshallbekeptonfileandarecurrent.

Requirements > Dulycompletedservicereports(byPCS)orpest-controlinspectionrecords(iftheserviceisperformed

byaninternalPCO)shallbekeptonfileandshallbecurrent.Reportsshallinclude,ataminimum,thefollowing:

– Name of pesticide applied– Quantity and concentration or dosage applied– Thenameoftheindividualconductingtheservice– Date of service– Applicationmethodused– Specificareawherepesticidewasapplied– Signsofanypestactivityobserved– Type of services performed– Corrective action(s) documented for frequent pest activity– Recordsoffollow-up,completionandverificationofactions,requestedbythepest-controltechnician

toavoidorresolveinfestationproblems–theseareavailableonfile.

7.4 Pest-control DevicesSummary:Pest-controldevicesshallbeadequatelyplacedtoavoidpestinfestationaswellascontamination.

Requirements > Thelocationsofpest-controldevicesshallbeadequatetoeffectivelycontrolpestinfestationandtoavoid

any contamination to product, packing materials or equipment.

> Thefollowingrestrictionsshallbeobserved:

– Rodent control– Allbaitstationsaresecuredtothewallorfloorandaretamper-resistant,soastominimize

movementofthedevice.– Thebaitusedmustnotbeofalooseorgranulartype.Itissecuredinsidethebaitstationbyarod

(horizontalorvertical)abovethefloorofthestationtoavoidthebaitbeingremovedbyarodentorfloatingawayintheeventofheavyrain.

– Thebaitstationislocatedatamaximumof50m/15ftintervalsaroundtheexteriorofthebuildingparameter.

– Allpestcontroldevicesarelocatedbetween7–12metres/23–40ftapart,andlocatedoneithersideofanyentranceintothebuildingfacility.Trapsarenotplacedoncurbing.

– Trapsareplacedsothatopeningsareparallelwithandclosesttothewall.– Insect control

– Insectelectrocuters(pulsedelectrocution)shouldnotbeallowedinzones2or3– Allinsectlighttrapsarefittedwithcatchtrays.

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– Insectlighttrapsarelocatedatleast1.5m/5ftfromprotectedorexposedproductorpackingmaterial.

– Insectlighttrapsarenotlocatedabovedockdoors.– Allinsecttraplightbulbsareshatterproof(withmetallicring).Coveringthebulbwithstickyplastic

isnotacceptableasitdecreasestheeffectofthelight.The above-specified intervals only serve as a guide. Pest-control evaluation is required depending on the size of the facility.

7.5 Pest-activity Trend AnalysisSummary:Pest-activitytrendanalysisshallbecarriedout.Correctiveactionsandareasforimprovementshallbeidentified.

Requirements > Pest-activitytrendanalysisshallbecarriedoutbythePCOorplant.

> Correctiveactionsandareasforimprovementshallbeidentified.

> Trendanalysisshallbecarriedoutforallpest-controldevicesintheplant.

> Trendanalysisshallbedoneatleastannually.

> Trendanalysisshallbeanalyzedaftereachservicingandreviewedaspartoftheassessment.ThisdatashallbeusedtoidentifyproblematicareasandcriteriaforimprovingthePestControlprogramme.

7.6 Pest ActivitySummary:Pestactivityshallnotbeevidenteitherinsideoroutsidethebuilding.

Requirements > Allareasshallbefreefromanyreoccurringorexistingpestactivities,including:

– Rodentactivity–evidenceofburrows,trails,excreta,tracks,gnawedbagsorcases.– Birdactivity–nestingaroundtheinteriorperimeteroftheplant,droppingsorfeathersintheinternal

areasofthewarehouse.– Liveanimalsinsidetheplantperimeter–cats,dogs,etc.– Insectactivitiesinsidetheplant–flyinginsects,cockroaches(smell,excreta),spiders(withactive

webs).– Decomposedrodent(s)ontrapsandbaitstations.

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8Product Control

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8. Product Control8.1 Temperature ControlSummary:Temperaturecontrolmeasuresfortemperature-sensitiveproductsoringredientsshallbeeffective.

Requirements > Alltemperature-sensitiveproductanditsprocessingroomsshallbemonitoredwithacalibrated

thermometerinthewarmestpartoftheroom.

> Facilitytemperature(wheretemperature-sensitiveproductsoringredientsarestored)shallbemonitoredand recorded at least twice daily.

> Docksshallbeenclosedandcooledtolessthan10C(50F)iftemperature-sensitiveitemsareshipped.

> Thawingofproductshallbeundertakeninequipmentandroomsappropriateforthepurpose.Wateroverflowshallbedirectedtothedrainageandnotontothefloor.

8.2 Contamination ControlSummary:Stepsshallbetakentopreventtheintroductionofforeignmaterialorcontaminationofanykindintotheproduct.

Requirements > Noevidenceofimminentcontamination–physical,chemicalormicrobiological–shallbeobservedduring

theaudit.

> Ifglovesareused,theyshallbesuitableforfooduse,ofadistinctivecolour(bluewherepossible),beintactandnotshedloosefibres.

> Ifsealsareusedduringwork-in-progress,sealswiththesamecolourastheproductshouldbeavoided.Theconditionofthesealsshallbeverified.

8.2.1 Foreign-body Control DevicesRequirements

> Theuseofforeign-bodycontroldevicesshallbeinplaceanddocumented.

> Thesiteshallhaveequipmentinplacetodetectorremoveforeignobjects.Theprocedureshallincludethefollowing:

– Typicalequipmenttobeconsideredasforeign-materialcontroldevicesmayinclude:– Filters– Sieve– Metal detection– Magnets– Optical sorting equipment– X-ray detection equipment– Otherphysicalseparationequipment–e.g.gravityseparation,fluidbedtechnology

> Theforeign-materialcontroldevicemustbeworkingandplacedascloseaspossibletothefinalpacking.

> Forproductspackedinfoilpackaging,anin-linemetaldetectorshallbeplacedbeforepacking,orelseanimaging system is used after packing.

> Verificationofthesensitivityofmetaldetectorsandimagingdevicesshallbeconductedbypassingmetalpiecesthroughthemiddleofthemetaldetectionarea,asitistheleastsensitive,resultingintheworst-casescenario.Itisbestpracticetopasseachtestpiecethreetimesinthenormalflowoftheproduct,with

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thestandardattheleading,middleandtrailingedgeoftheproduct,wherepossible.

> Verificationfrequencyshallnotbelessthan:

– Every8hoursiftheplantruns3x8hourshiftsaday– Atthestartandendoftheshiftiftheplantruns2shiftsadayorfewer(eveniftheyare12-hourshifts)

> Themetaldetectororx-rayequipmentshallbecalibratedexternallybyacompetentorganizationatleastannually.Magnetsshallbecalibratedatleastannually,butthiscanbedoneinternallywithaGaussmetertraceabletothenationalstandard.

> Themetaldetector(includingin-line)orimagingdevicemayincorporateoneofthefollowing:

– Anautomatedrejectiondeviceforcontinuouslinesystems,whicheitherdivertscontaminatedproductoutoftheproductflowortoasecureunitaccessibleonlytoauthorizedpersonnel

– Aprocesslineorconveyor-beltstopsystemwithanalarmwheretheproductcannotbeautomaticallyrejected(e.g.forverylargepacks)

> Thesensitivityofthedetectorissetaslowaspossibleandbasedonthelocationofthedetector,packagingsizeandanythingelsethatmayaffectthesensitivity.

– Themetaldetectionverificationshouldtargetasizeasfollows:– 1.5mm ferrous– 1.5mm non-ferrous– 2.5mm stainless steel (316 grade)

Wherethetargetisnotachievable,thesensitivityusemustbederivedfromHACCPanalysis.– UHTmilkproductsareexemptedfromthemetaldetectionstandardsaslongasrare-earthmagnets

are used.

Points for attention > Ataminimum,metaldetectionandimagingsystemtestingmustbeconducted:

– at start-up– atbreaks– after maintenance– attheendofaproductionrun

> Formetaldetectionwithoutapositiverejectiondevice,butwithanalarm,warninglightorbeltshut-offmechanism,awrittenprocedureonhowthesystemisrestartedandthedispositionofsuspectedproductsmustbeinplace.

> Aproductrejectionlogshallbekept,includinganalysisandcorrectiveactionsforanyforeignmaterials.

> Theinternalauditorshallverifythatthepositiverejectdeviceisoperatingcorrectly.Ifthemetaldetectororimagingdevicefails,theauditorshallcheckiftheproductwashandledaccordingtothewrittenprocedure.

> Theinternalauditorshallobservehowtheoperatorconductstheverificationaccordingtoprocedure,withoutmanagementinterference.

8.2.2 Metal Utensils Control and PolicyRequirements

> Aproceduretodefineaccountability,periodiccontrol(frequencyandrecords)anddisposalmeasuresshallbeimplemented.

> Specificcontrolsshallbeappliedforsharpmetalutensilsthatentailapotentialrisktohealthintheeventof contamination.

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> Theseutensilsinclude(butarenotlimitedto):knives,needles,sievewires,cuttingdevices,blades.

8.2.3 Wood PolicyRequirements

> Awoodpolicyshallbeinplace.Woodshallbebannedfromhigh-riskorhigh-carezones.Otherproductionandstorageareasmayhavewoodenpalletsunderriskassessment.

> Amapshowing‘woodallowed’and‘woodbanned’areasisrecommended.

> Someexceptionsmayexist;e.g.inflourmillsitistraditionaltohavewoodenframedsieves.Inthecaseofsuchexceptions,itisimportanttocheckthatthewooddoesnotposearisktothesafetyoftheproductand is in optimum condition (no splinters, not wet, etc).

8.2.4 Glass and Brittle/Hard Plastic Contamination ControlSummary:Awrittenprocedureonglassandbrittle/hardplasticshallbeestablished.Alllightsandglassareshieldedsoastopreventproductorpackingcontaminationintheeventofanybulborglassbreakage.

Requirements > Thepolicyorprocedureshallincludethefollowing:

– Noglassorbrittle/hardplasticsareusedinthefactory,exceptwherethisisnecessary.– Alistismaintainedofallessentialglassandbrittle/hardplasticswithinthemanufacturingfacility,

includingalllights,glassandbrittle/hardplasticsinproduction,warehousingandstorageareas.– Allglassandbrittle/hardplasticsareshieldedwithplasticfilmtopreventshatteringduringbreakage.

However,tamper-proofglassdoesnotrequireaplasticfilm.PlasticfilmshouldnotbeusedoverUVlightsformicrobiologicalloaddecreaseorelectronicflykillers,asthismaydecreaseefficiency.

– UsageofshatterproofbulbsinUVlightsorpest-controldevicesisnecessary.Amanufacturercertificateshouldbeavailable.

– Employeesarestrictlyprohibitedfrombringinginanypersonaleffectsthataremadefromglass,except for eyeglasses.

– Anybreakageofeyeglassesorlossofcontactlensesisimmediatelyreportedtomanagement.– Guidelinesareprovidedforreportinganybrokenglassorbrittle/hardplasticincidents,aswellas

instructions for disposal.– Alogofbrokenglassandhardplasticincidentsiskept,loggingwhat,where,whenandwhataction

hasbeentakentoanycompromisedproduct.– Ifanyreceptacle(suchasabottleorbeaker)isrequiredforsampling,itmustnotbemadeofglassor

hardplastic.– Abrittleandglassprogrammeisrequired.

Examples of brittle plastics are: Acrylic, Lucite, Optix, Plexiglas and Polycast. Brittle plastic shatters in a manner similar to glass. Example of soft plastics are: Polycarbonates, Lexan, Tuffak and Unicar. Soft plastic cracks but does not shatter.

8.2.5 Chemical Control (Including Cleaning Agents, Lubricants, etc.)Summary:Theuse,storageandhandlingofnon-foodchemicalsshallbecontrolledtopreventchemicalcontamination.

Requirements > Controlsshallinclude:

– Allchemicalsarekeptinlockedstoragetopreventunauthorizeduse.Thekeyiskeptbyauthorizedpersonnelonly.Storageofcleaningchemicalsissegregatedfromfoodandpackingmaterials.Thestorage area is in a clean condition.

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– MaterialSafetyDataSheets(MSDS)areavailable.– Thereisconfirmationofsuitabilityforuseinafood-processingenvironment.– Thesanitizerbottleintheproductionareaisadequatelylabelled,withtheword‘sanitizer’.– Cleaningchemicalsandsanitizersmaybeinproductionareasiftheyaresecuredanddonotpose

ariskofproductcontamination(e.g.sanitizerbottleonwallracks,drumsofchlorineonpalletsforautomaticdispensingsystemsorhanddipstations).

Lubricants > Onlyfood-gradelubricantsshallbeusedinallproductorpackingcontactsurfaces.

> Riskassessmentshallbecarriedouttoidentifywhichequipmentrequirestheuseoffood-gradelubricantorgrease,andthisisdocumented.

> Containersandgreasegunsoffood-gradelubricantsshallbeclearlylabelledorcolour-coded.

> Food-gradelubricantsshallbesegregatedfromnon-food-gradeitemstoavoidconfusionbetweenthetwo.

> Thereshallbeevidenceoffood-gradedeclaration–vialabel,MSDS,etc.

8.3 Allergen Control Summary:Anallergenmanagementandcontrolprogrammeshallbeestablishedtopreventcross-contactfrom allergenic material to non-allergenic material.

Requirements > Theallergencontrolprocedureshouldbeeffectiveandshallincludethefollowing:

– Amasterlistofingredientsidentifiedasfoodallergensshallbekept,andisupdatedwheningredientsidentifiedasfoodallergensarebroughtintothefacility.

– Ingredientsidentifiedasfoodallergensshallbeidentifiedinallrecordsofformulation,batchorrawmaterial production.

– Ataminimum,thefollowingfoodallergensshallbeaddressed:– Cerealscontainingglutenandproductsthereof– Crustaceans(includingshellfish)and/orproductsthereof– Molluscs(includingshellfish)and/orproductsthereof– Eggandproductsthereof– Fish/Seafoodandproductsthereof– Peanutsandproductsthereof– Soybeansandproductsthereof– Milkandproductsthereof– Nutsandproductsthereof– Celeryandproductsthereof– Mustardandproductsthereof– Sesameandproductsthereof– SulphurDioxide&Sulphites– Lupinandproductsthereof– Beepollen,royaljellyandproductsthereof

> Aproductionschedulingorchange-overprocedureshallbeinplacetoensurethatallergensarenottransferredtoanon-allergen-containingproduct.Verificationofchangeoveractivityshallbeconductedandrecordsofthisshallbemaintained.

> Allergencontrolshallincludeallergenseparationinstoragewithclearlabels,theclean-upprocedurefor

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allergenic ingredient spills, utensils and storage containers control, etc.

> Thereshallbespecificsanitationpracticesthatpreventcross-contaminationofallergenstonon-allergenproducts.

> Verificationofsanitationshallbeimplementedtoensurenoallergenscross-contaminate.

> Ingredienthandlingpracticesshallbeinplace–e.g.weighingdoesnotleavescopeforcross-contamination of allergens to non-allergen products and ingredients.

> Thereshallbeadefinedprocedureonthereworkhandlingofproductcontainingallergen–e.g.properlabellingofreworktoidentifyproductandtypeofallergenpresent,etc.

8.4 Sensitive Products, Claims and Chain of CustodySummary:Systemsshallbeinplacetoensurethatallproductdescriptionsandclaimsarelegal,accurateandverified.

Tosubstantiateclaims,procedureandrecordsshallbeinplacetoensurechainofcustody.

Requirements > Amasterlistofsensitiveingredientsshallbeupdatedwhensensitiveingredientsarebroughtintothe

facility.

> Whereclaimsaremadeonproductsandlabelledassuchperagreedspecificationwhicharedependentonthestatusofarawmaterial,thestatusofeachbatchoftherawmaterialshallbeverified.Theseclaimsinclude:

– Halal– Kosher– geneticallymodifiedorganism(GMO)status– identity preserved – Authenticityclaim(species,variety,organic,etc)– specificprovenanceororigin– breed/varietalclaims– assuredstatus(e.g.GlobalG.A.P.)

> Thefacilityshallmaintainpurchasingrecords,traceabilityofrawmaterialusageandfinalproductpackingrecordstosubstantiateclaims.Thesiteshallundertakedocumentedmassbalancetestsatafrequencytomeettheparticularschemerequirementsoratleastevery6monthsintheabsenceofascheme-specificrequirement.

> Whereclaimsaremadeaboutthemethodsofproduction(e.g.organic,halal,kosher)thesiteshallmaintainthenecessarycertificationstatusinordertomakesuchaclaim.

> Theprocessflowfortheproductionofproductswhereclaimsaremadeshallbedocumentedandpotentialareasforcontaminationorlossofidentityascertained.Appropriatecontrolsshallbeestablishedtoensuretheintegrityoftheproductclaims.

8.5 Water ContaminationSummary:Aprocedureshallbeinplacetopreventcontaminationfromwaterorice.

Requirements > Theproceduretopreventcontaminationfromwaterorice,whenusedasaningredientorthroughcontact

withfoodingredients,shallinclude:

– A150-micronwaterfilter(orsmaller)shallbeusedatpointofuseorearlierintheflow.

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– AllfiltrationdevicesshallbeincludedinthePreventiveMaintenanceprogramme,andrecordsaremaintained.Thereportincludes:– Dateoflastcheck– Conditionofequipmentandfilter– Correctiveactionwherefiltersneedrepairorreplacement– Namesofpersonnelwhoperformedthemaintenance

– IfUVlightisusedtosterilizewater,recordsshallbekeptofthehoursofuseofthebulbs,andthechanges.Bulbmaximumhoursofuseforefficiencyshallbecertifiedbythemanufacturer.

– Back-flowdevicesshallbeinstalledwherenecessary,especiallyinCIPsystemsandwhereprocessingwater is recycled.

– Wateroriceusedasaningredientoronadirect-contactsurfaceshallcomplywithdrinkingwaterregulations.

8.6 Control of Non-conforming ProductSummary:Controlofnon-conformingproductshallbeestablished.

Requirements > Non-conformingproductshallbeidentifiableandshallposenoriskofcontamination.Acceptablewaysof

segregating or identifying non-conforming products are:

– Redstickerswiththewording:OnHold,QuarantinedorNon-Conformingareused(ineachpalletifshrink-wrapped,otherwiseineachbox/bag).

– Astockcontrolsystem(SAP)orsimilarisusedwhereitisimpossibletoloadnon-conformingproductas every pallet or unit is controlled

– Whensegregated,non-conformingareasexist,theyareclearlydelimitedandshallnotallowconfusion.

– Forbrandedortrademarkedproduct,proceduresshallbeinplacetodemonstratedestructionofpackagingaswellasproducttoavoidfraudormistakesinbringingitbacktothemarket.

– Decision-makingresponsibilitiesshallbeclearlydefined,andactionstakenmusthavesupportingdocumentation as evidence.

8.7 Finished Product ReleaseSummary:Aprocedureforreleaseoffinishedproductshallbeestablishedtoensureproperrelease.

Requirements > Whenproductsrequirepositiverelease,thereshallbearecordedprocedureshowingthattheproductwas

notdispatcheduntilthereleasecriteriahadbeenappliedandreleasewasauthorized.

– Therolesandresponsibilitiesforeffectiveimplementationshallbeclearlydefined.

– Allcriteriaortestparameterstobemetpriortoreleaseshallbelisted.

> ACertificateofAnalysisshallbeprovidedinaccordancewithKerryGrouppolicy.

8.8 Operations ControlSummary:Operationscontrolshallbeadequate,withworkinstructionsandprocessspecificationinplace.

Requirements > Documentedprocessspecificationsandworkinstructionsshallbeavailabletostaffasatrainingand

supporttool.Theinstructionsmustinclude:

– Recipes or formulas, mixing instructions– Equipment process settings

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– Cooking/coolingtimeandtemperatures– Labellinginstructions– Codingorbatchdefinition– Shelf-lifemarking– Anyspecificfoodsafetyrequirementsintheprocess(CCP,OPRP)– Packing procedures to ensure product is properly closed for safety and quality during at least its

shelf-life

> Whenimportanttotheprocess,parametersshallberecorded–suchastemperatures,times,pressure,conductivity, etc.

> Intheeventofspecificationsdeviation,proceduresshallbeinplacetoestablishthequalityorsafetyoftheproduct..

8.9 Quantity ControlRequirements

> Weight,volumeandnumbercontrolchecksshallbecarriedoutatapredeterminedfrequencytoensureappropriateweightlabelling(minimumweight,netweight,etc).Thechecksandmethodshallbedocumented.

8.10 Calibration ProgrammeSummary:Allinstrumentscriticaltosafety,qualityorlegalityshallbecalibrated.

Requirements > Allinstrumentscriticaltosafety,qualityorlegalityshallbecalibratedatapredeterminedfrequency,based

on risk.

> Allcalibrationsshallbetraceabletothenationalorinternationalstandard.

> Recordsofallthecalibrationsshallbekept(inascheduleorprocedure).

> Calibrationrecordsshallinclude:

– InstrumentIDorserialnumber– Rangeofcalibration– Dateofcalibration– Validityofthecertificate(ifexternalcertificateisissued)– Nameoftechnicianconductingthecalibration– Referenceinstrumentusedinthecalibration,fortraceabilitypurposes– Recordfindingsbeforeandaftercalibration

> Aqualifiedmemberofstaffmustreviewthecalibrationandverifythatitisinlinewithagreedcontractualparameters.

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9Food Fraud

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9. Food Fraud

9.1 Food Fraud DocumentSummary:AFoodFraudprogrammeisestablishedtopreventintentionaladulterationforeconomicgain.

Requirements > Theassessmentmethod,assessmentelementcover,classificationofrisklevelandmitigationapproach

versustheriskidentifiedshallbedefinedanddescribedindetail.

> ManagementshallappointadesignatedresponsiblepersontotheFoodFraudprogramme.

> Activities(includingtraining)aimedatincreasingawarenessandknowledgeoffoodfraudinrelationtotheirrawmaterialandpackagingmaterialshallbeestablished.

9.2 Document AssessmentSummary:Adocumentedfraudvulnerabilityassessmentshallbecarriedoutforallrawmaterialorgroupsofraw material in relation to potential risk of adulteration in any form.

Requirements > Therawmaterialscopeandgroupingforassessmentshallbedescribed.

> Thefoodfraudrisksshallbeidentified.

9.3 ClaimsSummary:Whereclaimsconcerningproductauthenticityaremadeonproductlabelsand/orpertaintoaspecificrawmaterial,and/ormethodsofproduction,thesiteshallmaintainnecessarydocumentation(e.g.certification)aspartofverification.

Requirements > Relevantevidence–e.g.certificationandtestingreports–shallbeavailabletosupportproductclaims.

> Recordsofthelatestcertificationdateandexpirationdateshallbeavailable.

9.4 Testing ProcedureSummary:Appropriateassuranceand/ortestingprocessesareinplacetoreducetheriskofadulterationbasedonthefoodfraudvulnerabilityassessment.

Requirements > Mitigationactionsshallbeidentifiedagainsttherisksidentified.

> Recordsofmitigationactionidentified(e.g.verificationrecord,testingreport,processcontrolprogramme,etc)shallbemadeavailable.

9.5 Assessment Review and Change ManagementSummary:AwrittenprocedureforthereviewoftheFraudVulnerabilityAssessmentprogrammeisestablishedandreviewedatleastannuallyorwhenevertherehasbeenachangeintheeconomiccircumstancesandmarketintelligencethatmayalterthepotentialrisk.

Requirements > Thelastreviewingdateandexpectednextreviewingdateshallbespecified.

> Reviewprogrammedetailonminimumreviewfrequency,triggercriteriaandevidenceoflastreviewshallbeavailable.

> Relevantactionandchangestakenshallbedocumented.Managementcontrolsindicatinghowthechangeswereimplementedshallbeavailable.Recordsshallbeavailable.

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10Food Defence and Security

Programme

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10.FoodDefenceandSecurityProgramme10.1 Food Security ProgrammeSummary:AFoodSecurityprogramme,basedonriskorthreats,shallbeestablishedtopreventintentionalharmto employees, products and processes.

Requirements > Allentrancestothefacilityshallbemonitoredtoprotectfromunauthorizedintrusion,andbeequippedwith

appropriate control devices.

– Examples of monitoring: use of security guards, CCTV system. – Controldevicesmayincludeasimplelockingmechanism,self-lockingdoor,accesscontrolsystem,etc.

> Visitors(includingcontractors)tothefacilityshallbemanagedandcontrolled.

> ItismandatorytosealtrucksandcontainersofallloadstoKerry.Allshipmentsoftruckloadsorfull-loadorders,includinganytransferbetweenfacilitiesandwarehouses,areproperlysealedwithnumberedtrailerseals.Thesealnumberisrecordedinthebilloflading,theinvoiceorothersalesdocumentaccompanyingtheload.Betweendeliveries,all‘lessthantruckload’shipments(LTLs)arerequiredtobelockedwithapadlock.

> Supplierrecords–whetherincomingingredients,packagingorfinishedproduct–shallbereceivedinlockedand/orsealedvehiclesorcontainers.Sealnumbersarerecorded.

> Stagedvehiclescontainingfoodproductsshallremainlockedwhileonthesupplier’spremises.

> Alloutboundvehiclesshallbelockedand/orsealedbeforeleavingthesupplier’sdock.

> Accesstothelaboratoryshallberestricted,includingsensitivematerialssuchasreagentsandbacteria,drugs, toxin positive control, etc.

> Accesstothecomputerprocesscontrolsystemandformulationorrecipeshallberestricted.

> Water-handlingfacilities,waterstorageandwaterwellsshallbesecuredwithlocks.

> Theinteriorandexteriorofthefacilityshallbeadequatelylit.

> Accesstoairintakepointsforfacilitieswithdirectpneumaticconveyanceofingredientsorproducts(flour,drymix,etc)shallbesecured.

> Tamper-evidentpackagingshallbeused.

> Allstaffshallbetrainedinsitesecurity,includingtheneedtoreportimmediatelytomanagementorsecurityanyunknownorsuspiciouspersononthepremises(seeA7:Trainingprogramme).

> DesignatedpersonnelshallmanagetheFoodSecurityprogramme.

10.2 Food Security Programme ReviewSummary:TheFoodSecurityprogrammeshallbereviewedatleastannually.Correctiveactionsshallberecorded.

Requirements > TheFoodSecurityself-auditprogrammeshallinclude:

– Alistofpersonnelresponsibleforthereview– Thepersonnelresponsibleforupdatingtheprogrammewhenanewriskorareaisincluded

– Achecklistthatincludesallareasrelevanttofoodsecurity

– Anannualreview.

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11TraceabilityandProductRecall

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11.TraceabilityandProductRecall11.1 Traceability ProcedureSummary:Atraceabilityprocedureshallbeestablishedforallingredients,finishedproductandproductpackaging.

Requirements > Atraceabilityprocedureshallbeestablishedthatallowsallingredients,finishedproductandproduct

packagingtobetracedtotheirlotnumbersandthroughouttheirentirehistoryfromreceivingtodistribution,enablingidentitypreservationwhenrequired.

> Thetraceabilityprocedureshallincludethefollowing:

– Allincomingmaterials,includingbulk,shallbeadequatelyidentifiedandlabelledwithmaterialname.Distinctcodesareassignedtothematerial.

– Thetraceabilitycodingsystemshallnotbelimitedtorawmaterials.Alltypesofpackaging,processingaids,intermediateorsemi-processedproducts,partlyusedmaterials,finishedproductsandmaterialspending investigation are also included.

– Typesofrecordsinvolvedandhoweachrecordisusedshallbedefined.– Thespecifictraceabilityinformationavailableoneachrecord,includingthepersonnelresponsible,

shallbedefined.– Howthecodingsystemisinterpretedshallbedefined.– Themethodtolinkeachingredientandfoodcontactpackagingmaterialtofinishedproductlotsor

identificationshallbespecified.– Themethodtotrackproductioncodesshippedtoeachexternalcustomershallbespecified.– Themethodstomaintainfulltraceabilityofreworkand/orrepackthatallowtrace-backtotheoriginal

productionlotshallbespecified.– Traceabilityshallbechallengedandrecordsshallbekept(traceabilityexercise)atleastannually,

backwardsandforwards.– Systemsoftraceabilityandidentification,whichensurethatclaimsrelatingtoprovenanceorassured

statuscanbesubstantiated,shallbemaintained.TheseclaimsorstatusmaybeKosher,Halal,GMO-free, allergens declaration, etc.

11.2 TraceabilityCodingandIdentificationSummary:Rawmaterials,workinprogress,finishedproductsandpackingmaterialsshallbeproperlyidentified.

Requirements > Allrawmaterials,workinprogress(includinganyreceptacleincontainers),finishedproductsand

packagingmaterialsshallbeclearlylabelledandidentifiedinsuchawaythattheycanbeeasilytracked.

> Thecodingcomplieswiththecodingsystemasdefinedintheproducttraceabilityprocedure(see11.1:TraceabilityProcedure).

> Allcontainersformanufacturinguse,includingwastecontainersandspraybottles,shallbeproperlylabelledwiththeintendedcontents.

> Ifcolour-codingisusedforidentification,adequatesignageshallbeplacedinrelevantareas,indicatingthecolour-coding interpretation.

> Recordsoftrainingoncolour-codingusageshallbeavailableonfile.

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11.3 Product Recall ProgrammeSummary:TheProductRecallprogrammeshalldefinethesteps,personnelandcommunicationplansforeffectiveexecution.

Requirements > AwrittenProductRecallprogrammeshallbeestablished.Itshalldefineallthesteps,personneland

communicationneededtoensureeffectiveexecution. The term ‘recall’ here includes ‘withdrawal’.

Theprogrammeshallincludethefollowing:– Keypersonnelonthesupplier’srecallteamshallbeidentified,andtheirresponsibilitiesshallbe

clearly outlined.– Guidelinesshallbeprovidedondecidingwhetheraproductneedstoberecalledorwithdrawn.– Anupdatedemergencycontactlistshallbemaintainedandreadilyavailable.Thecontactlistshall

includetherecallteam,suppliers,customersandregulatoryauthorities.– Thereconciliationanddisposalofrecoveredproductshallbespecified.– Thecommunicationplanshallincludetheprovisiontoinformcustomers,consumersandregulatory

authoritiesinatimelymanner.

11.4 Mock RecallSummary:Theproductrecallprocedureshallbetestedatleastannually,andrecordsshallbemaintained.

Requirements > Theproductrecallprocedureshallbetestedatleastannuallytoensurethatitoperateseffectively.Records

shallbekeptofthetestsandtheirresults.

The term ‘recall’ here includes ‘withdrawal’.

– Themockrecallexerciseshallbeconductedfromrawmaterialandprimarypackaging(foodcontact)tofinishedproductsdelivered.– Finishedproductscanbetracedfromlotcodebackwards,uptorawmaterialandprimary(food

contact) packaging.– Rawmaterial/primarypackagingcanbetracedfromlotcodeforwardtofinishedproduct.

– Themockrecallexerciseshallbecompletedwithinasettarget.Thesummaryofthemockrecallandtraceabilityresultsincludes:– Identificationoftherawmaterial,packagingmaterialorfinishedproducttraced– Dateandtimeofmockrecallexercise–whenstartedandcompleted– Listofrecordsreviewedtoobtaintheamountofproductsinvolved– Summary of calculation – i.e. amount of material received at plant, amount of material located in

storage, total product (disposed of, in use, etc), percentage of material recovered, total amount of product produced, total amount of product recovered, percentage of product located, etc.

– Documentedreviewbytherecallteam,includingtesteffectivenessbasedonamountofproductrecovered,anyissuesuncoveredandopportunitiestoimprovethesystem

– Listofwhoshouldbenotifiedincaseofactualproductrecall– Documentedretestwithin60daysofanymockrecallthatfails– TheformulasinAnnexVIIIareusedtocalculatethemassbalanceandcapacityofrecoveringall

theproductNote: A failure is defined as recovering <95% or >105% of the product.

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11.5 Traceability(ChainofCustody)VerificationProgrammeSummary:ATraceabilityVerificationprogrammemustbeinplacetoverifythatthesuppliercanidentify,trackandlocate100%ofrawmaterial,ingredientsandpackagingmaterialtofinishedproductsoldtoKerry.

Requirements > Atraceabilityexerciseshallbeconductedtoverifychainofcustodyforwardtocustomerandbackwardsto

asupplier/primaryprocessor/farm/grower,todemonstratethattheyareabletotracebackthrougheachstepinthechainofcustodyandtocountryoforigin.

> ForwardtraceabilitytoKerry.

> TraceabilitybackwardsmaystartfromaKerryPOalreadydelivered.Inthiscase,customersreceivingthesamebatchbeingtracedbackorsimilarmustbeidentified.

> Thetraceabilityverificationeitherbackwardsorforwardmustidentifyallrawmaterials,ingredients,packagingrework,workinprogress,productonholdornon-conforming,aswellasproductdisposedof.

> Thetraceabilityexerciseshallbecompletedwithinatargetof2hoursandamaximumof4hours.

> Supportingdocumentsarerequiredforverificationandmustincludemassbalance.TheformulasinAnnexVIIIareusedtocalculatethemassbalanceandcapacityofrecoveringorlocatingthetotalityofproduct.

Note: A failure is defined as taking longer than 4 hours.

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12Shelf-lifeofProductDelivered

toKerry

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12.Shelf-lifeofFoodProductDeliveredtoKerry12.1 Shelf-life of Food Product Delivered to KerryAttimeofdelivery,ingredientsshippedtoKerryshallnothavelessthanthefollowingminimumlifeonreceipt(MLOR),asapercentageoftheoriginalshelf-lifeavailableattheendofmanufacture:

> Localproducts–75%ofmanufactureshelf-life

> Internationalproduct–50%ofmanufactureshelf-life

> Byexception,materialoutsideoftheseparametersmaybereceivedwhereallregulatoryrequirementsarestillmetwithrespecttothegoodssuppliedtoKerry.

Forthespecificshelf-lifedetailsofsensitiveproducts,pleaserefertothepurchasingcontractandtheKerryrawmaterialspecification.

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13CertificateofAnalysisfor

ProductDeliveredtoKerry

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13.CertificateofAnalysisforProductDeliveredtoKerry13.1 CertificateofAnalysisRequirementsSummary:ACertificateofAnalysis(CoA)isamandatorydocumentissuedbythesupplierthatatteststothequalityofthesuppliedmaterialaccordingtospecifiedqualityattributesdefinedintheagreedspecification.TheCoAindicatestheresultsofspecifictestsoranalysisperformedonadefinedlotofthesupplier’sproduct.

Requirements > Asaminimum,theCertificateofAnalysismustlistallcriterialistedinAnnexII.

> Asaminimum,vendorsmustprovideahardcopyoftheCertificateofAnalysisinlinewithAnnexIIforeachdeliveryandlotnumber.

> Inaddition,thevendorscanalsoemailcopiesoftheCertificateofAnalysis.

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SustainabilityCorporateSocialReposnsibility

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SummaryThecompanyadherestoKerryrequirementsonEnvironmental,Workplace,MarketplaceandCommunitysustainability,detailedintheKerrySupplierCodeofConduct.

Requirements ThecompanyshouldensurethatthisSupplierCodeofConductiscommunicatedandreadbyallappropriatestakeholdersinordertocarryoutthesecommitments.BelowisthecurrentversionoftheSupplierCodeofConductasofthetimeofdistributingtheKerrySupplierRequirementsManual.

Introduction Aspartofourmissionwearecommittedtothehigheststandardsofbusinessandethicalbehaviour,tofulfillingourresponsibilitiestothecommunitieswhichweserveandtothecreationoflongtermvalueforallstakeholdersonasociallyandenvironmentallysustainablebasis.WearecommittedtotheresponsiblesourcingofgoodsandservicesandthisSupplierCodeofConductsetsoutourexpectationsofthosewhoprovidethesegoodsandservicestotheGroup.

Thiscodeisinformedbyanumberofinternationalstandardsandguidancedocuments,includingtheUNGuidingPrinciplesonBusinessandHumanRights,theInternationalLabourOrganisation’s(ILO)DeclarationonFundamentalPrinciplesandRightsatWork,theChildren’sRightsandBusinessPrinciples,theConventionontheProtectionoftheRightsofAllMigrantWorkersandMembersofTheirFamilies,andtheConventionontheEliminationofDiscriminationAgainstWomen.

Purpose and Scope ThisCodeofConductsetsouttheminimumstandardsweexpect,andweencourageallsupplierstogobeyondtheserequirements.Theterm‘Supplier’asusedinthiscodereferstosuppliers,vendors,contractors,consultants,agentsandotherprovidersofgoodsandserviceswhodo,orseektodo,businesswithKerryGroup worldwide.

Kerry’scommitmenttoresponsiblebusinesspracticeisclearlydefinedwithinourGroupCodeofConductandweunderstandtheneedfordialoguewithworkers,suppliersandstakeholderswhomweimpactonacrossourwidervaluechain,particularlythosewhomaybemoreatrisk.Wepursuecontinuousengagementwiththesestakeholdersandrepresentativebodiestoadoptandsharebestpracticeandensureadherencewiththerequirementssetoutbelow.

Suppliersshallapplytheserequirementstotheirownsuppliers,contractlabourproviders,andapprovedsub-contractorswithwhomtheyworktosupplygoodsandservicestoKerryGroup,ensuringcompliancewiththeletterandspiritofthiscode.Theseprinciplesformpartofthesupplierselectionprocessandaresubjecttocontinuedmonitoring.Wherethereisapre-existingrelationshipwithasupplier,therequirementsofthiscodeareinaddition,andnotinlieuof,anylegalorcontractualagreementbetweenthatsupplierandKerryGroup.

Business Conduct Standards Asaresponsiblebusiness,KerryGroupsetsthehigheststandardsforthewayweconductouroperations.Inturn,weexpectsupplierstoconductbusinessresponsibly,withintegrityandtransparency.Furthermore,weexpectsupplierstotreatallemployeesfairly,honestlyandwithrespect,infullcompliancewiththefollowingrequirements:

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Child Labour Requirements

> Suppliersshallnotpermittheuseofchildlabour.Nochildbelowtheageforfinishingcompulsoryschooling,or15yearsofage(whicheveristhegreater)maybeemployedbyasupplier,subjecttoILOexceptions.

> Whereyoungpeopleundertheageof18areemployed,supplierswillensurethattheirworkisnotlikelytobeharmfultotheirhealthand/ordevelopment,includingnoworkingunderhazardousconditionsandensuringcompliancewithallapplicablelaws.

Forced LabourRequirements

> Suppliersshallnotpermittheuseofforcedorinvoluntarylabourofanytype(i.e.forced,trafficked,bonded,indenturedorinvoluntaryprisonlabour)andworkersshallbefreetoleaveemploymentwithoutpenaltyontheprovisionofreasonablenotice.

> Suppliersmustensurenofeesorrelatedcostsarechargedtoapplicantsandworkersforrecruitmentandthatnomonetarydeposits,financialorcollateralguaranteesorpersonalpossessionsaredemandedasacondition of employment.

> Suppliersmustensurethatworkersarenotheldindebtbondageorforcedtoworkforanemployer,oranyotherentitytopayoffdebt.

> Suppliersshallnotrestrictworker’sfreedomofmovement,requireworkerstoremainattheworkplaceattheconclusionoftheirworkinghoursorconfinetheminanyworkeraccommodation.

Migrant WorkersRequirements

> Suppliersmustensurethatallemployeeshavethelegalrighttoworkandanymigrantworkersshouldbeinpossessionofavalidworkpermitissuedbytherelevantauthority.

> Suppliersshallimplementeffectivemeasurestoprotectmigrantemployeesagainstanyformofdiscrimination.

Freedom of Association and Collective BargainingRequirements

> Suppliersshallrespecttherightsofemployeestoorganiseandjoin,orrefrainfromjoining,workerorganisationsandtobargaincollectively.Supplierswillallowworkplaceaccessforsuchorganisationstofacilitatetheirrepresentativefunctions.

> Intheabsenceoflegalprotectionsfortherighttocollectivebargainingorfreedomofassociation,supplierswillseektoengageworkersthroughalternativelawfulmechanismsthatallowworkerrepresentation on workplace issues.

> Suppliersmustdevelopandimplementmechanismsforresolvingindustrialdisputes,includingemployeegrievances,andensureeffectivecommunicationwithemployeesandtheirrepresentatives.

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Discrimination / Fair TreatmentRequirements

> Suppliersshallnotdiscriminateinhiring,compensation,accesstotraining,promotion,terminationorretirementonthegroundsofrace,caste,religion,age,nationality,socialorethnicorigin,sexualorientation, gender, gender identity or expression, marital status, family status, pregnancy, union membership,politicalaffiliation,disabilityorotherlegallyprotectedclass.

> Suppliershallrespecttherightsofwomenandseektocreateanenvironmentinwhichtheycanaccessopportunitiestoparticipateintheworkplaceonanequalbasis.

> Theuseofphysicalabuse,verbalorsexualharassmentorintimidationofworkersshallbeprohibitedbysuppliers.

WagesRequirements

> Suppliersarerequiredtoinformworkersabouttheiremploymenttermsandconditionsinwritingandinanunderstandablemannerbeforetheyenterintoemployment.

> Suppliersshallensurethattheiremployeesarefairlycompensated.Ataminimum,compensationmustcomplywithallapplicablewageandhourlaws,orindustrystandardsapprovedonthebasisofcollectivebargaining,whicheverishigher.Suppliersshouldaimtoprovidecompensationforaregularworkweekthatissufficienttomeetworkers’basiclivingneedsandprovidesomediscretionaryincome.

> Deductionstowagesshallonlybemadeinaccordancewithapplicablelaworundercollectiveagreementandallworkerswillbeprovidedwithclearandwrittendetailsoftheirwageseachtimetheyarepaid.

Working HoursRequirements

> Suppliersmustprovideforworkinghoursthatcomplywithnationallawsandindustrystandards.Regularhoursworkedshallnottypicallyexceedsixtyhoursperweek,(includingovertime)andworkerswillbeprovidedwithonedayoffineverysevendayperiod.

> Overtimeshallbevoluntaryandcompensatedatapremiumrate.Allovertimerelatedpracticeswillbeconductedinaccordancewithapplicablelawsandregulatorystandards.

> Suppliersshallnotseektoavoidobligationstoworkersunderlabourorsocialsecuritylawsandregulationsarisingfromtheregularemploymentrelationshipthroughtheexcessiveuseoffixedtermcontracts,labour-onlycontracting,subcontracting,home-workingorapprenticeshipschemes.

Occupational Health & SafetyRequirements

> Suppliersshallensureallemployeesworkwithinsafeandhumaneconditions,includingprovidingadequatetrainingandeffectiveprotectiveequipmenttosafelycarryouttheirduties.Supplierswillalsoprovideaccesstocleantoiletfacilities,potablewaterandsanitaryfacilitiesforfoodstorage.

> Facilitiesmustbeconstructedandmaintainedinaccordancewithapplicablelawsandregulations.Accommodation,whereprovided,shallbeclean,safeandmeetthebasicneedsofworkerswhilerespectingtheirdignity.Supplierswillalsoensurethatthereareappropriateexits,proceduresandequipmentinplacetodealwithemergencysituations.

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Land RightsRequirements

> Suppliersshallrespecttherightstolandtenureoflocalcommunitiesandindigenouspeoplesimpactedbyitsoperations,includingitsrawmaterialsourcing,andwilladheretotheprincipleofFree,PriorandInformedConsent.

Business EthicsRequirements

> Inkeepingwithourcommitmenttoexercisingappropriatestandardsofprofessionalismandethicalconductinallbusinessactivities,KerryGroupwillnottoleratebriberyorcorruptioninanyform,oranyactsthatcontraveneitsAnti-BriberyPolicy.

> Suppliersandbusinesspartnersarenotpermittedtodirectlyorindirectlypromise,offerorprovideanyimproperadvantagetoanypersonorentity,includingofficialsofagovernmentoragovernment-controlledentity.KerryGroup’semployeesarenotallowedtoacceptanysuchadvantageandweexpectthesameapproachinbusinessdealingsfromourbusinesspartners,suppliersandthirdparties.

> Suppliersareexpectedtomaintainaccuraterecordsoftheiractivitiesandperformancethatclearlydemonstratecompliancewithallapplicablestandards,regulationsandKerryGrouprequirements.

> Suppliersmustdiscloseanypersonalrelationships,economicinterestorothertiestotheirbusinessheldbyanemployeeorcontractorwithKerryGroup.

> SuppliersshalltakeappropriatemeasurestosecureandprotectallconfidentialinformationrelatedtoitsrelationshipwithKerryGroupanduseitonlyforthepurposeauthorisedundercontractualagreement.Thisobligationshallremaininforceregardlessofthestatusofthebusinessrelationship.

EnvironmentRequirements

> SupplierstoKerryGroupshallcarryoutoperationswithcarefortheenvironmentandataminimumwillcomplywithallapplicableenvironmentallawsandregulations.

> KerryGroupexpectssupplierstomakeprogressiveimprovementsintheiroperationsandthroughadoptionofgoodoperatingpractices,toensuretheresponsibleuseofnaturalresources,cleanerproduction,pollutionpreventionandthecreationofproductswithlowerenvironmentalimpacts.

> Kerryrecognisestherighttowaterandsuppliersmustimplementpracticestoensuregoodwaterstewardship,includingoptimisingtheuseofwateronsite,employingadequatewastewateroreffluentcontrolstoprotectthesurroundingenvironmentandensuringwithdrawalsdonotadverselyimpactontheneedsoflocalcommunitiesandotherwaterusers.

> SuppliersarerequiredtobetransparentabouttheirrawmaterialsourcingpracticesandtoshareuponrequestrelevanttraceabilityinformationthatsupportsKerry’sbroaderresponsiblesourcinggoals.

Compliance KerryGrouprequiressupplierstoensuretheiroperationscomplywithallapplicablelawsandregulationsataminimum.Furthermore,weexpectthatallsuppliersadheretoKerryGrouprequirements,includingthestandardsaslaidoutinthisSupplierCodeofConduct.

Suppliersshallhavetheappropriateprocessesandsystemsinplacetodoso,includingameansfortheconfidentialreportingofconcernsaboutmisconductorunethicalbehaviourandanappropriatemechanismtoremedyadverseimpacts.Whereissuesareidentifiedthroughinternalreporting,whistle-blowerswillbeprotectedfromanynegativerepercussions.Similarly,suppliersshallnottoleratethreats,intimidation,physical

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orlegalattacksagainsthumanrightsdefenders.

SuppliersshallcooperatewithKerryGrouptoallowtheGroup,oranyauthorisedthirdparty,toconductauditstoverifycompliancewiththesestandardsorotherrequiredcertifications.Intheeventdeficienciesareidentified,thesupplierwilltakethestepsnecessarywithinanacceptabletimeframetocorrectanydeficiencytoKerryGroup’ssatisfaction.Suppliersshallimmediatelyreportanyconcernsaboutcompliancewithlegalrequirementsoranyaspectofthiscode,totheirdesignatedpointofcontactorthroughourconfidentialreporting facility: www.kerrygroup.ethicspoint.com.

WheresuppliersarefoundtohavecontravenedtherequirementssetoutinthisCode,KerryGroupreservestherighttoterminateanyassociatedagreementorbusinessrelationship.

ReferencesSecond-party supplier requirements or standards

> ConAgra–SupplierandCo-ManufacturersExpectationsManualversion4(April2019)

> PepsiCoGlobalSupplierCodeofConduct( June2018)

> KraftFoodsSQEManual(December2019)

> McDonald’sGlobalSQMSV4(February2017)

> McDonald’sCodeofConduct(November2012)

> Yum!GlobalCodeofConduct(April2020)

> Yum’schecklistFoodsafetyaudit(2017)

Third-party industry standards > BRC issue 8

> FSSC22000version5

> JointIPEC–PQGGoodManufacturingPracticesGuideforpharmaceuticalexcipients2006

> SQF Code Edition 8.1

Others > CodexAlimentarius,link:http://www.codexalimentarius.org/

> Subject-matterexpertsinKerry.

> Sedex, link: https://www.sedex.com/

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Glossary

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GlossaryAllergen Aknowncomponentoffoodthatcausesphysiologicalreactionsduetoanimmunologicalresponse(e.g.nutsandothersidentifiedinlegislationrelevanttothecountryofproductionorsale).

AuditAsystematicexaminationtosubstantiatewhetheractivitiesandrelatedresultscomplywithplannedarrangements,andwhetherthesearrangementsareimplementedeffectivelyandaresuitabletoachieveobjectives.

CalibrationAsetofoperationsthatestablish,underspecifiedconditions,therelationshipbetweenvaluesofquantitiesindicatedbyameasuringinstrumentormeasuringsystem,orvaluesrepresentedbyamaterialmeasureorreferencematerial,andthecorrespondingvaluesrealizedbystandards.

CertificateofAnalysis(CoA)Adocumentprovidedbythesupplierthatindicatestheresultsofspecifictestsoranalysisperformedonadefinedlotofthesupplier’sproduct.Thetestsaredoneeitherbythesupplierorbyanexternaltestingfirm,andmustbebasedonprotocolsormethodsthathavebeenapprovedandagreedbyKerrytechnicalexperts.

CertificateofAuthenticityAdocumentprovidedbythesupplierthatauthenticatesthefoodclaimsinaccordancewithcountryregulations.

Chain of CustodyThisreferstoeverylinkinthesupplychainbacktofarm,fieldorocean,coveringeverytimetherawmaterialismoved,paidfor,handled,storedorprocessed.

Reviewingthefullchainofcustodyshouldincludeasupply-chainmapdetailingalladditionalprocesses,handlers,agentsandstorage,suchasfreezinganddefrosting,payingparticularattentiontothelong,convolutedsupplychainsandwheretherawmaterialoringredientisnolongerrecognizablefromitsoriginalformat.

Cleaning in Place (CIP)Theprocessofcleaningandsanitizingfood-processingequipmentinitsassembledpositionwithouttheneedfordismantlingandcleaningtheindividualparts.

Code of ConductTheSupplierCodeofConductoutlinesthesocialnormsandrulesandresponsibilitiesof,orproperpracticesfor, an individual, party or organization.

Codex AlimentariusThebodyresponsibleforestablishinginternationallyrecognizedstandards,codesofpracticeandguidelines.HACCPisonesuchstandard.

CompetenceDemonstrableabilitytoapplyskill,knowledgeandunderstandingofataskorsubject,toachieveintendedresults.

Contamination Introductionoroccurrenceofanunwantedorganism,taintorsubstanceinfoodorthefoodenvironment.Typesofcontaminationincludephysical,chemical,biologicalandallergenic.Contaminationcanalsomeanincorrect mixing of packages.

Control MeasureAnyactionoractivitythatcanbeusedtopreventoreliminateafoodsafetyhazardorreduceittoanacceptablelevel.

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CookAthermalprocessdesignedtoheatafooditemtoaminimumof70degreesCelsiusfor2minutes,orequivalent.

Corrective ActionActiontoeliminatethecauseofadetectednon-conformitydeviation.

Country of ManufactureThecountryofmanufacture(KerryalsoreferstothisasGoodsSupplierLocation)iswherethegoodsareproduced,inaccordancewithnationallaws.

Country of OriginPlaceofprovenanceoftheprimaryingredientofaproduct.

Critical Control Point (CCP)Astepatwhichcontrolcanbeappliedthatisessentialtopreventoreliminateafoodsafetyhazardorreduceittoanacceptablelevel.

Critical Limit Acriterionthatseparatesacceptabilityfromunacceptability.

CustomerAbusinessorpersontowhomaproducthasbeenprovided,eitherasafinishedproductorasacomponentofthefinishedproduct.

FeedAnysubstanceorproduct,includingadditives,whetherprocessed,partiallyprocessedorunprocessed,intendedtobeusedfordirectorindirectfeedingtoanimals.

Feed SafetyAconceptthatfeedwillnotcauseharmtoanimalsoradverselyaffecthumanhealthwhenusedaccordingtoits intended purpose

First in First Out (FIFO) Amethodofstockrotationinwhichnewsuppliesareshelvedbehindoldsupplies,sothattheoldsuppliesareusedfirst.

First Expired First Out (FEFO) Amethodofstockhandlingofperishableproductsorproductswithaspecifiedexpirydateinwhichtheproductwiththedeadlineforthenextintakewillbethefirsttobeservedorremovedfromstock.

Flow Diagram Asystematicrepresentationofthesequenceofstepsoroperationsusedinproducingormanufacturingafooditem.

Food Handler Anyonewhohandlesorpreparesfood,whetheropen(unwrapped)orpackaged.

Food SafetyAssurancethatfoodwillnotcauseharmtotheconsumerwhenitispreparedoreatenaccordingtoitsintended use.

GeneticallyModifiedOrganism(GMO)AnorganismwhosegeneticmaterialhasbeenalteredbythetechniquesofgeneticmodificationsothatitsDNAcontainsgenesnotnormallyfoundthere.

Global Food Safety Initiative (GFSI)ManagedbytheConsumerGoodsForum,aprojecttoharmonizeandbenchmarkinternationalfoodsafetystandards: www.mygfsi.com

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Good Manufacturing Practice (GMP)Proceduresandpracticesthatareimplementedusingbest-practiceprinciples.

HazardAbiological,chemical,physicalorallergenicagentinfood,oraconditionoffood,thathasthepotentialtocauseanadversehealtheffect.

Hazard Analysis and Critical Control Points (HACCP)Asystemthatidentifies,evaluatesandcontrolshazardsthataresignificantforfoodsafety.

Heavy MetalSilver,arsenic,barium,selenium,lead,mercury,cadmiumandhexavalentchromium.Thelistisnotexhaustive.Compliancewithregulationaspercountryofmanufacturingshouldbedocumented.

High-care Area or ZoneAnareadesignedtoahighstandardwherepracticesrelatingtopersonnel,ingredients,equipment,packagingandenvironmentaimtominimizeproductcontaminationbypathogenicmicro-organisms.

High-care Product

Aproductthatrequireschillingorfreezingduringstorage,isvulnerabletothegrowthofpathogens,hasundergoneaprocesstoreducemicrobiologicalcontaminationtosafelevels(typically1-2logreduction)andisreadytoheatoreat.

High-risk Area or ZoneAphysicallysegregatedarea,designedtoahighstandardofhygiene,wherepracticesrelatingtopersonnel,ingredients,equipment,packagingandenvironmentaimtopreventproductcontaminationbypathogenicmicro-organisms.

High-risk ProductAchilledready-to-eatorready-to-heatproductorfoodwherethereisahighriskofgrowthofpathogenicmicro-organisms.

Identity PreservedAproductthathasadefinedoriginorpuritycharacteristicthatneedstoberetainedthroughoutthefoodchain(e.g.throughtraceabilityandprotectionfromcontamination).

Indicator OrganismsMicro-organismsthatmaynotthemselvesbeconsideredpathogenic,butwhosepresencemayindicateunsanitaryconditionsand/orpotentialpresenceofspecificpathogens.Forthepurposesofthismanual,indicatororganismsforsalmonellainwetenvironmentswouldincludetotalentericbacteriaorcoliforms.IndicatororganismsforL.monocytogeneswouldbeoftheListeriagenus.

Ingredient / Raw MaterialsAcomponentofafoodorfeedthathasundergoneprocessing

Internal Audit Thegeneralprocessofaudit,forallactivitiesofthecompany,conductedbyoronbehalfofthecompanyforinternal purposes.

Letter of GuaranteeAdocumentconfirmingongoingconformancetoagreedspecificationsandbusinessrequirements.

Lot or Batch (lot number)Auniqueidentitygiventoadefinedquantityofamaterial,usuallybasedontimeandlocationofmanufacture.Forcontinuousprocesses,alotmaynotexceedtheamountofmaterialproducedinone24-hourperiod.Fornon-continuousprocesses,thebatch,blend,shiftorothertimesegmentmaybeusedtoidentifyalot.Formaterialsreceivedinbulk,thelotisusuallyidentifiedasthecontentsofthebulkvehicle.

Low-risk Area or ZoneAnareawheretheprocessingorhandlingoffoodspresentsminimumriskofproductcontaminationorgrowth

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ofmicro-organisms,orwherethesubsequentprocessingorpreparationoftheproductbytheconsumerwillensure product safety.

Mock RecallAsimulatedrecallprocess.Thisexercisehelpstoensurethattraceabilityproceduresareadequateandtoidentifyopportunitiesforimprovementintheeventofarealrecallsituation.

Potable Water

Waterthatissafetodrink,isfreefrompollutantsandharmfulorganisms,andconformstolocallegalrequirements.

PrerequisiteThebasicenvironmentalandoperationalconditionsinafoodbusinessthatarenecessaryforproducingsafefood.Thesecontrolgenerichazardscoveringgoodmanufacturingpracticeandgoodhygienicpractice,andareconsideredintheHACCPstudy.

Primary PackagingAnypackagingthatisindirectcontactwiththeproduct,e.g.soft-drinkbottles,sweetwrappersortheinnerbagofcerealboxes.

ProcedureAnagreedmethodofcarryingoutanactivityorprocessthatisimplementedanddocumentedintheformofdetailedinstructionsorprocessdescription(e.g.aflowchart).

ProcessSetofinterrelatedorinteractingactivitiesthattransforminputsintooutputs.Processesinanorganizationaregenerally planned and carried out under controlled conditions, to add value.

Processing AidAnysubstancenotconsumedasafoodbyitself,intentionallyusedintheprocessingofrawmaterials,foodortheiringredientstofulfilacertaintechnologicalpurposeduringtreatmentorprocessing,andwhichmayresultintheunintentionalbuttechnicallyunavoidablepresenceoftheresiduesofthesubstanceoritsderivativesinthefinalproduct–providedthattheseresiduesdonotpresentanyhealthriskanddonothaveanytechnologicaleffectonthefinishedproduct.

Product RecallAnymeasuresaimedatachievingthereturnofanunfitproductfromcustomersandfinalconsumers.

Product Withdrawal Anymeasuresaimedatachievingthereturnofanunfitproductfromcustomers,butnotfinalconsumers.

QualityQualityconsistsofthoseproductfeaturesthatmeettheneedsofcustomers.Itisthedegreetowhichasetofinherentcharacteristicsfulfilsrequirements.Foodsafetyisanintegralpartofthequality.

Quality Management SystemAmanagementsystemthatdirectsandcontrolsanorganizationwithregardtoqualityandfoodsafety,includingtheestablishmentofqualityandfoodsafetypoliciesandobjectives,planning,control,andcontinuousimprovement.Amanagementsystemapproachencouragesanorganizationtoanalyzecustomerrequirements,todefinetheprocessesthatcontributetotheachievementofaproductthatisacceptabletothecustomer,andtokeeptheseprocessesundercontrol.

Quantity Check / Mass BalanceAreconciliationoftheamountofincomingrawmaterialagainsttheamountusedintheresultingfinishedproducts, also taking into account process waste and rework.

Ready-to-eat FoodFoodintendedbythemanufacturerfordirecthumanconsumptionwithouttheneedforcookingorotherprocessing,effectivetoeliminateorreducetoanacceptablelevelmicro-organismsofconcern.

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Recognized Laboratory AccreditationLaboratoryaccreditationschemesthathavegainednationalandinternationalacceptance,awardedbyacompetentbodyandrecognizedbygovernmentbodiesorusersofthestandard(e.g.ISO17025orequivalents).

Rework Materialleftoverfromproduction,whichisreusedtomakethesameorasimilarproduct.Thiscanbepartprocessedmaterialorfinishedproduct.

Risk AnalysisAprocessconsistingofthreecomponents:riskassessment,riskmanagementandriskcommunication.

Risk AssessmentTheidentification,evaluationandestimationofthelevelsofriskinvolvedinaprocess,todetermineanappropriate control process.

Root CauseTheunderlyingcauseofaproblemthat,ifadequatelyaddressed,willpreventarecurrenceofthatproblem.

Seasonal Production SitesAproductharvestedandprocessedonasitethatisopenedspecificallyforthedurationoftheshorttermofthatharvest(typically12weeksorless)duringa12-monthcycle.

SupplierAnyperson,firm,companyorotherentitytowhomacompany’spurchaseordertosupplyfoodorfeedingredients, packaging or a service is addressed.

TACCP Threatanalysisandcriticalcontrolpoints.

Third-party manufacturersAnon-Kerrycompanysubcontractedtomanufactureorprovideanyservicetomanufactureanyproduct,whetherpartiallyorfullyprocessed.

Traceability Theabilitytotraceandfollowafood,feed,food-producinganimalorrawmaterialthatisintendedtobe,orexpectedtobe,incorporatedintoafood,throughallstagesofreceipt,production,processinganddistribution.

TrendAnidentifiedpatternofresults.

UtilityAcommodityorservice,suchaselectricityorwater,thatisprovidedbyapublicbody.

VACCPVulnerabilityassessmentandcriticalcontrolpoints.

Validation Confirmation–byprovidingobjectiveevidence–thattherequirementsforthespecificintendeduseorapplicationhavebeenfulfilled.

VerificationConfirmationbyprovidingobjectiveevidencethatspecifiedrequirementshavebeenfulfilled.

Work in ProcessPartiallyfinishedgoodswaitingforcompletion;productthatisheldoverorremovedfromthenaturalproductionflowtobeblendedlaterintoproduction.

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Annex

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IAnnex

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AnnexISupplier Code of ConductKerry’sSupplierCodeofConductmaybeupdatedfromtimetotime.Themostup-to-dateversioncanbefoundontheKerryGroupcorporatesustainabilitywebsite:http://www.kerrygroup.com/sustainability/policies-statements/

kerrygroup.com © Kerry 2020

KERRY GROUP PLC

Code of Conduct Policy Document

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IIAnnex

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AnnexIICertificateofAnalysis(CoA)RequirementsACertificateofAnalysis(CoA)isamandatorydocumentissuedbythesupplierattestingtothequalityofthesuppliedmaterialaccordingtospecifiedqualityattributesdefinedintheagreedspecification.

Thecertificateofanalysis(CoA)givestheresultsofspecifictestsoranalysisperformedonadefinedlotofthesupplier’sproduct.ACoAmusthavethefollowingminimuminformationfortheKerryGroup:

General Information

Supplier Name <<Nameofcompanyprovidingthecertificate>>

SupplierAddress <<Addressofthecompanyprovidingthecertificate>>

Contact Details

Quality Contact <<Primaryqualitycontactand/orCoAcreator>>

PhoneNumber <<Phonenumberofthecompanyprovidingthecertificate>>

EmailAddress <<EmailaddressoftheprimaryqualitycontactorCOAcreator>>

Supplier Manufacturing Site Name

<<Shouldbeidentifiedifdifferentfromthesuppliername>>

Supplier Manufacturing Site AddressandCountry

<<Addressofthemanufacturingsiteifdifferenttosupplieraddress>><<Countryofmanufacturingsite>>

ApprovedSupplierManufacturingSiteNumber

<<KerrySupplierManufacturingSiteNumberasnotedontheContract/PO>>

Customer <<Kerry’sfactorythatwillreceivethecertifiedmaterial>>

KerryPurchaseOrderNumber

<<KerryPurchaseOrdernumberforthecertifiedmaterial>>

Material Name <<Nameoftherawmaterial/finishedproduct>>

KerryMaterialNumber <<Kerrymaterialcode>>

Product Code <<Suppliermaterialcode>>

Manufacturing LOT Code <<Codeassignedtoabatchtoidentifythecertifiedmaterial>>

Quantity <<Amountofmaterialsuppliedinunits,KG,etc>>

Date of Manufacture <<Dateofmanufacturerorproductionofthematerial>>

CertifiedMinimumShelf-life <<Minimumshelf-lifeofthecertifiedmaterial>>

Best Before Date <<Datebywhichmaterialisbestbefore>>

Country of Origin <<CountryofOriginofprimaryrawmaterial>>

StabilityStatement <<Transportationandstorageconditions(e.g.storeat10degreesC)–ifrequired>>

Analysis Section

Critical Property <<Criticalqualitypropertyidentifiedintheagreedspecification>>

TestMethod <<Testmethodusedandtestmethodrevisionnumber>>

UOM <<Unitofmeasure(e.g.Kg,L)>>

Minimum Limit <<ThisacceptancerangemustbeKerrycriteriaunlessthemanufacturerrangefallswithintheKerryrange>>

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Maximum Limit <<ThisacceptancerangemustbeKerrycriteriaunlessthemanufacturerrangefallswithintheKerryrange>>

Test Result <<Actualvaluesofthebatch/lotinsamemetricsasKerryspecification>>

CertificateofCompliance/Status

<<ThismaterialcomplieswiththeKerryspecificationsetforthinreferencespecification>>

DateofApproval <<Datewhenthematerialwasapprovedbythesupplier>>

NameoftheAnalyst <<Printedname(s)andsignature(s)oftheanalyst(s)whoperformedtheanalysis/analyses>>

NameoftheApprover <<Printedname(s)andsignature(s)oftheapprover(s)orauthorizer(s)>>

<<Supplier Name>>

<<Supplier Address>>

Certificate of AnalysisGENERAL INFORMATION

Supplier Manufacturing Site Name: Supplier ABCD Co. Ltd.Supplier Manufacturing Site Address and Country: Supplier ABCD Co. Ltd.

Customer: Kerry Address: Kerry Address, PO Box, Phone Number

1. Contact DetailsQuality Contact: Assigned primary quality contactPhone number: Phone number of the company providing the certificateEmail Address: Email address of the primary quality contact

2. Purchase InformationApproved Supplier Manufacturing Site Number: XXXXXX (as noted on contract or PO)Kerry Purchase Order Number: XXXXXX

3. Material InformationMaterial Name: Pepper Black Cracker 12# HTKerry Material Number: 20008806Product Code: XXXXXXManufacturing LOT Code: 123456789Quantity: 25kgDate of Manufacture: 2 Dec 2016Minimum Shelf Life: 60% of declared shelf lifeBest Before Date: 2 Dec 2017Country of Origin: VietnamStability Statement: Temperature less than 30ºC (or 86ºF). Relative humidity less tha 60%. All products shall be stored at appropriated condition and must be transported in hygenic conditions and must be such that it protects the goods from contamination and adverse conditions.

ANALYSIS SECTION

Critical Property Test Method UOMMinimum

LimitMaximum

Limit Test ResultsWater activity FCC Ed 10 0.65 0.55Fine Ferrous Metal FCC Ed 10 ppm 20 100 65Moisture FCC Ed 10 % w/w 12 12 12Ash FCC Ed 10 % w/w 4.49 7 5.28Volatile Oil FCC Ed 10 % w/w 1 2Pinerine FCC Ed 10 % 3.9 4.5

Results: this material complies with the Kerry specification set forth in reference specification.

Signature Signature<<Name of Analyst>> <<Name of Approver>>

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Raw Material Non Conformane (RMNC)Ininstanceswhereasupplierfailstomeettherequirementsstatedabove,KerrywillraiseaRawMaterialNon-Conformance(RMNC)forCertificateofAnalysis(CoA)orGeneralInformationissues,forexample:

Defect Description

Illegible Documentcannotberead(i.e.:printisunclearonCoA)

NoCoAprovided Certificateofanalysismissingfromdelivery(e.g.:analysisorgeneral information)

Missing Supplier Plant Location Documentdoesnotincludethelocationoftheplantthatmanufacturedthematerial

IncorrectSupplierPlantLocation Documentcontainstheincorrectmanufacturingplant

Missing Material Name Documentdoesnotcontainthematerialname

IncorrectMaterialName Documentcontainstheincorrectmaterialname

MissingPONumber DocumentdoesnotcontainthePurchaseOrderNumberofthecertifiedmaterial

MissingMaterialSAPCode DocumentdoesnotcontaintheKerrySAPcode

MisalignmentofShelf-life Documentcontainsadifferentminimum/maximumshelf-lifeofcertifiedmaterialintheagreedspecification

MissingShelf-life Documentdoesnotcontainminimum/maximumshelf-lifeofthecertifiedmaterial(i.e.missingexpiry/used-by)

Parameteroutofspecification CriticalparameterisoutofspecificationonCoA

MissingSignature/SystemValidation CoAdoesnotcontainsignature/systemvalidation

MissingSpecificationProperty CoAdoesnotcontainallcriticalqualitypropertiesidentifiedintheagreedspecification

MisalignmentofTestMethods CoAcontainsanincorrecttestmethodthatwasused

Missing UOM CoAdoesnotcontainunitofmeasure(e.g.Kg,L)

Missinglot#/DOM/othersuppliergeneral information

Ingredient/rawmaterialdeliveryformatdoesnotincludelabel/dataregardinglotnumber,dateofmanufacture(DOM),suppliername, supplier address

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IIIAnnex

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AnnexIIIGMP General RequirementsActions not allowed in GMP areas

> Eatingordrinking–permittedinauthorizedareasofthefacilityonly.

> Chewinggum,candies,throatcandies,throatlozengesandtobacco.Holdingtoothpicks,matchsticksorotherobjectsinthemouth.

> Wearingfalseeyelashes,fingernailsorfingernailpolish.

> Carryingobjectsabovethebeltorwaistline(e.g.flashlight,thermometers,placingpensorcigarettesbehindtheears).

> Expectorating (spitting) in production or storage areas.

> Rings(otherthanweddingbands),watches,earrings,necklaces,orotherjewellery(includingornamentsorpiercinginexposedbodyareassuchasthetongueandthenose).

Other issues to be considered > Ifsmokingisallowedinthefacilities,onlyindesignatedareas.

> Badgesandclip-onidentificationcards,ifused,mustbewornbelowthewaisttoavoidbeingpotentialsource of contamination.

> Buttons,servicepinsorsimilararticlesarenotpermittedonuniforms,smocks,bumpcapsorhardhats.

> Lunchesmustbestoredindesignatedareas.Lunchesmustbecompletelyenclosedincleanable/reusablecontainers or in single-use packing.

> Personallockersmustbemaintainedfreeofwasteandsoiledclothing.Foodanddirectproductcontacttoolsmustnotbestoredinemployee’slockers.

Clothing and personal equipment > Allclothingmustbekeptingoodrepair.Employeeclothingshouldnotbeasourceofcontamination.

> GMPareas:EmployeeswhoworkinGMPareasmustwearonlycompany-approvedclothing.Clothingprovidesadequatecoveragethatensureshair,perspirationorotherforeignmaterialsdonotcontaminatetheproduct(e.g.noshorts,tanktops,sleevelessshirts).

> Non-productionemployees,contractorsandvisitorswhoentertheGMPareamustwearalaboratorycoat(orotherapprovedcovering)andwearappropriatefootwearconsistentwiththeplantpolicy.

> Pocketsabovethewaistmustberemovedorsewnshut.Onlyzippers,grippersorsnapsmaybeusedasthefastenersonshirts,coats,laboratoryjacketsorsmocks.

> Restricteduses:Workweardedicatedtospecificproductareasmustberestrictedtothoseareas.Suchareasmustbedefinedinlocalprocedures(typicallyhigh-careareaswhereclothingchangeisrequiredonentryandexit).Suchworkwearisnotpermittedinotherplantornon-plantareaswheretheymaybesubjecttoallergenormicrobiologicalcontamination(e.g.cafeteria,externalrestareas,anyareanotsubjecttoGMPcontrols).

> Shoes:tohelpavoidproductcontamination(andforpersonalsafety),shoesworninGMPareasshouldbedesignedandconstructedasfollows:fullyenclosed(noopentoes,openweave,orsandals)madewithleatherorvinyloutermaterial(nocanvasornylonmesh),low-heeled.Solegroovedepthmustnotbeasourceofcontamination.Shoesinwetmicrobiologicallysensitiveareasmustnotallowpassageofwaterfromthebaseoftheshoes(shouldnottraporabsorbwaterwhenwalkingthroughfootbathsatroomentrances).

> Safetyhelmets:Thesemustbemaintainedinasanitarycondition.Labelsorstickersareprohibited.Helmetsusedinmicrobiologicallysensitiveareasmustbecleanedandsanitizedatafrequencydeterminedbyplantquality.Helmetsmustnotbeusedforstoringorcarryingobjectssuchascigarettes,notepads,

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food and pens.

> Earprotectiondevices:Thesemustbesecuredtopreventproductcontamination.Theyincludeearplugsattachedbystringwornaroundtheneck,earplugswithrigidattachmentwornaroundtheneck,andearmuffsattachedbyheadband.

> Ifavailable,particularlyinfacilitieswhereproductionlinesareequippedwithmetaldetectors,itisrecommendedthatmetaldetectableearplugsbeused.Earplugsmustbecolourfulandeasilydifferentiablefromproductcolour.

> PersonnelworkinginGMPareasmustwashhandsatthefollowingtimes:beforeenteringaGMParea;uponre-enteringtheGMParea;aftereachvisittothetoiletfacility,restroom,andlunchandbreakroomfacilities;priortotouchingproductorproductcontactsurfaces;oranytimewhenhandshavebecomesoiled or contaminated.

> Personnelworkinginamicrobiologicallysensitiveareamustsanitizetheirhandsafterproperwashingandaftertouchingnon-productcontactsurfaces.Ifsoilisobservedonhands,handsmustbewashedbeforeresanitizing.

> WhenworkinginGMPareas,theuseofhandsforunsanitarypracticesmustbeavoided.Especially,handsshouldnotbeusedtoscratchheadorbody,touchfaceorwipeforehead,andfingersshouldnotbeplacedonorinthemouth,nose,orears.

> Handlotionsmustnotbeusedifhandsareindirectcontactwithproductorproductcontactsurfaces.However,approvedglovesmaybewornoverhandshavingnon-perfumedlotion,ifcompatiblewithworkconditions and regulatory rules.

> Personnelwithminorcutsorinjuriesonhandsmustbeabletoprotectthewoundandkeepitcleanandfreefrominfection.Theywillbeallowedtoworkonproductionlinesprovidedthecutsarebandagedandcoveredwithanimpermeablesanitarymaterial.Adhesivebandagesmustbemetal-detectableinfacilitieswheremetaldetectorsareused.

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AnnexIVCommunicable DiseasesPathogens and diseases from pathogensCurrentlyrecognizedpathogensordiseasesfrompathogensthatcanbetransmittedbyfoodthathasbeencontaminatedbyaninfectedperson:

Often Transmitted Occasionally Transmitted

HepatitisAvirus Campylobacter jejuni

Norwalk(-like) viruses (Norovirus) Entamoeba histolytica

Salmonella typhi Enterohemorrhagic escherichia coli

Shigella species Enterotoxigenic escherichia coli

Staphylococcus aureus Giardia lamblia

Streptococcus pyogenes Nontyphoidal

Salmonella rotavirus

Taenia solium

Vibrio cholerae 01

Yersinia enterocolitica

Cryptosporidium parvum

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AnnexVEnvironmental TestingAir quality required

ENVIRONMENTAL AIR COMPRESSED AIR

Product Category Organism Air Exposure Air Sampler

Postheattreatmentorpasteurization;productswithAw<0.65(processing,fillingandpacking)

Yeast and mould

<100cfu/15min

<1000cfu/m3

<1.4cfu/m3

Dairy powder Yeast and mould

<10cfu/15min <500cfu/m3

Postheattreatmentorpasteurization;productswithAw0.65–0.95(processing,fillingandpacking)

Yeast and mould

<10cfu/15min <500cfu/m3

Postheattreatmentorpasteurization:productswithAw>0.95(processing,fillingandpacking),hotfilled

Yeast and mould

<10cfu/15min <500cfu/m3

Postheattreatmentorpasteurization:productswithAw>0.95(processing,fillingandpacking),coldfilled

Yeast and mould <5cfu/15min <100cfu/m3

Meat products Yeast and mould <5cfu/15min <500cfu/m3

Products allowing survival of micro-organisms,butnotsupportinggrowth.

Yeast and mould <5cfu/15min <1000cfu/

m3

Pathogen environmental testingIndicators:Indicateunsanitaryconditionsandpotentialpresenceofpathogens:

> Coliforms

> E coli

> Enterobacteriaceae(asanalternativetoColiformandEcoli)Quantitative testing – enumeration of these organisms

Note

Salmonella – Pervasive2 environmental micro-organism, well adapted to dry and warm environments. High tenacity in production of products such as chocolate, dairy powders and dry mixes.Qualitative testing – presence /absence

Listeria – Ubiquitous3 environmental micro-organism, well adapted to wet and cold environments. High tenacity in dairy and meat production. Qualitative testing – presence /absence

Areas for pathogen environment testing > Direct contact surfaces

> Indirectproductcontactsurfaces–surfacesthattouchdirectproductcontactsurfacesduringnormalequipment operation, e.g. scrapers

> Non-productcontactareasadjacenttoproduct–surfacesthatundernormaloperatingproceduresdo

2 Present or noticeable in every part of a thing or place. Tendency to infiltrate or spread. Seeming to be in all places, widespread. 3 Seeming to be in all places, widespread.

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notcontacttheproductorproductcontactsurfaces,e.g.exteriorofequipment,chillunits,panelbuttons,aprons,handles,etc

> Non-productcontactareasintheprocessingroom–moreremotesurfacesfromproduct,e.g.drains,walls,floors,handtrucks,etc

> Areasremotefromproductcontactsurfacesoutsidetheprocessingroom,e.g.hallways,bathroomdoor,cafeteria, cooler, etc

Atleastfiveswabsshouldbetakenfromeachareaeachmonth.

Sampleswithinthesameareamaybeacompositeofuptofivesamplepointsinonecomposite.

Test results acceptance criteria for Indicator Organisms

Coliforms/Enterobacteriaceae E coli

Rating Cfu/100cm2 (15.5in) Rating Cfu/100m2 (15.5in)

Target <10 Target Absent

Acceptable 10–20 Acceptable <10

Notacceptable >20 Notacceptable >10

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AnnexVIPalletConfigurationTI-HI,Ti-High,Tie-High,orTibyHiisatermoftenusedinthelogisticsindustry.Itreferstothenumberofboxes/cartonsstoredonalayerortier(theTI)andthenumberoflayershighthatthesewillbestackedonthepallet(theHI).Itcanalsobeusedinreferencetothestackingpatternusedtoloadapalletinordertogeneratearelativelystablestack(refertoFigure1).

Example of Ti-HiFigure 1

Wheremanufacturersdesignandstackboxes/cartonsonpalletsinnon-standardTi-Hipatterns,thisstackingpatterndoesnotcomputelogicallytoTI-HIapplications.Palletswithnon-standardTi-Hiareunconventionalandlessstable(refertoFigure2).

Example of Non-standard Ti-HiFigure 2

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AnnexVIISanitationVerificationParametersAfter wet cleaningSwabbingshouldbeperformedaftercleaningbutbeforesanitizingprocedures.

Swabmethods,samplingsitesandsamplesize/areamustbedefinedforeachzonebasedontheHACCPstudy,whichshouldspecifycriticalpoints.

Ataminimum,thecleanequipmentswabsshouldbetakenafterthemicrobiologicalcontrolstepwherecontaminationcouldoccur(e.g.heattreatment).Ifswabsaretakenaftersanitizing,properbuffersolutionsmustbeusedtopreventinaccurateresults.

Individualsperformingswabbingmustreceivepropertraining.

Clean Equipment Swab – Post Heat treatment – taken before sanitize:

Post Heat treatment – taken before sanitize

Post Heat treatment – taken after sanitize

Cfu / 100cm2 Cfu / 40in2 Cfu / 100cm2 Cfu / 40in2

APC Target <50 <100 <5 <10

Acceptable <50 <1000 <50 <100

Coliforms Target <5 <10 N/A N/A

Acceptable <50 <100 <5 <10

Lactobacillus Target <5 <10 N/A N/A

Acceptable <50 <100 <5 <10

Yeast Moulds Target <5 <10 N/A N/A

Acceptable <50 <100 <5 <10

Meat products – others

APC (aerobic plate count) Coliform

Cfu / 100cm2 Cfu / 40in2

OperationalSwab Good <100 <1000 N/A N/A

Brine Good <1000cfu/ml Negative/100ml

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AnnexVIIIFormulas for Mass Balance CalculationA. Tracingfinishedproductbackwards:

Where:PR: product recovered %A: product delivered to customers

Whenprocessdoesnotallowtheexactcalculationfromrawmaterial,alternativeformulacanbeused,asfollows:

Where:PR: product recovered %A: product delivered to customers

B. Tracing raw material forward:

*1:Ingmasstransferredtoproduction=

%ofInginFPformulaxFPmass 100 +expected process loss

PR =

PR =

x100

x100

100

+ FP or inprocess waste

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ΣAmass+wasterecorded+expectedprocessloss

Σ ingredients mass

ΣAmass

Totalmassproducedinthespecificbatch/lot

Ingredientlocated%=

IngmassinRMstorage+Ingmassdisposedof+Ingmasstransferredtoproduction*1

MassIngreceived

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