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PAM9005:Issue5andModuleself-assessmenttool BRCGlobalStandardforPackagingandPackagingMaterials,Issue5Issue2:December2016 Page1of41

BRCGLOBALSTANDARDSSELF-ASSESSMENTTOOL

Module9–BRCAuditOneWelcometotheBRCGlobalStandardsSelf-Assessmenttool

WehopethatyouwillfindthisusefulwhenpreparingyoursiteforanauditagainsttheBRCGlobalStandardforPackagingandPackagingMaterialsIssue5andAuditOnerequirements.ThistoolwillbeapplicableforallBRCGlobalStandardforPackagingandPackagingMaterialsissue5auditsintheHighHygieneCategorywhenusingtheAuditOnemodule.

HowtousetheBRCGlobalStandardsSelf-Assessmenttool

ThistoolisdesignedtohelpyouassessyouroperationagainsttherequirementsoftheStandardandtheModuleandhelpprepareyouforyourcertificationaudit.Modulerequirementsaredenotedintintedboxes.

ThechecklistcoverseachoftherequirementsoftheStandardandtheModuleandmaybeusedtocheckyoursite’scompliancewitheachoftheserequirements.Thechecklistalsoallowsyoutoaddcommentsoridentifyareasofimprovementintheemptyboxesprovidedattheendofeachsection.

Whilewehopethatthistoolisusefulinhelpingyouprepareforyouraudititshouldnotbeconsideredasevidenceofaninternalauditandwillnotbeacceptedbyauditorsduringanaudit.

Training

TheBRCTrainingAcademyhascoursesavailabletoimprovetheunderstandingoftherequirementsfortheBRCGlobalStandardforPackagingandPackagingMaterialsissue5andmaybeusefulforthepersonusingtheBRCGlobalStandardsSelf-AssessmentTool.Forfurtherinformationonthecoursesavailablepleasevisitwww.brctrainingacademy.com

FurtherInformation

Ifyouhaveanyfurtherquestionsaboutthisself-assessmenttoolorIssue5pleasedonothesitatetocontacttheBRCGlobalStandardsteam.

Email–[email protected]

Telephone–02078548939


Ref. Clause

1 SeniorManagementCommitment

1.1 SeniorManagementCommitmentandContinualImprovement

SOI Thecompany’sseniormanagementshalldemonstratethattheyarefullycommittedtotheimplementationofrequirementsoftheGlobalStandardforPackagingandPackagingMaterials.Thisshallincludeprovisionofadequateresources,effectivecommunicationandsystemsofreviewtoensurecontinualimprovement.Opportunitiesforimprovementshallbeidentified,implementedandfullydocumented.

1.1.1 Thesiteshallhaveadocumentedpolicywhichstatesthesite’sintentiontomeetitsobligationtoproducesafeandlegallycompliantproductstothespecifiedquality,andconfirmsitsresponsibilitytoitscustomers.Thisshallbe:

• signed by the person with overall responsibility for the site

• communicated to all staff.

1.1.2 Thesite’sseniormanagementshallestablishclearobjectivestomaintainandimprovethequality,safetyandlegalityofproductsmanufactured,inaccordancewiththeproductsafetyandqualitypolicyandthisStandard.Theseobjectivesshallbe:

• documentedandincludetargetsorclearmeasuresofsuccess

• clearlycommunicatedtorelevantstaff

• monitored,andtheresultsreportedatasuitablepredeterminedfrequencytothesite’ssenior

• management

• reviewedatleastannually.

1.1.3 Thecompany’sseniormanagementshallprovidethehumanandfinancialresourcesrequiredtoeffectivelyimplementtheprocessesofthequalitymanagementsystemandproductsafetyprogrammeandmaintaincompliancewiththisStandard.

1.1.4 Thecompany’sseniormanagementshallhaveasysteminplacetoensurethatthesiteiskeptinformedofandreviews:

• scientificandtechnicaldevelopments

• industrycodesofpractice

• allrelevantlegislationapplicableinthecountryofmanufactureand,whereknown,thecountry

• wheretheproductwillbeused

• anychangestotheStandardorprotocolpublishedbytheBRC.

1.1.5 Thesiteshallhaveagenuine,currenthardcopyorelectronicversionoftheStandardavailable.

1.1.6 WherethesiteiscertificatedtotheStandard,itshallensurethatrecertificationauditsoccuronorbeforetheauditduedateindicatedonthecertificate.


1.1.7 ThemostseniorproductionoroperationsmanageronsiteshallparticipateintheopeningandclosingmeetingsoftheauditfortheGlobalStandardforPackagingandPackagingMaterialscertification.Relevantdepartmentalmanagersortheirdeputiesshallbeavailableasrequiredduringtheaudit.

1.1.8 Thesite’sseniormanagementshallensurethattherootcausesofnon-conformitiesidentifiedatthepreviousauditagainsttheStandardhavebeeneffectivelyaddressedtopreventrecurrence.

Asystemshallbeinplacetocloseoutnon-conformitiesraisedininternal,second-partyandthirdpartyaudits,withconsiderationoftherootcause.

Notes

1.2 ManagementReview

SOI Thesite’sseniormanagementshallensurethatamanagementreviewisundertakentoensurethattheproductsafetyandqualitysystemisbothfullyimplementedandeffective,andthatopportunitiesforimprovementareidentified.

1.2.1 Managementreviewmeetingsattendedbythesite’sseniormanagementshallbeundertakenatappropriateplannedintervals;asaminimumannually.

1.2.2 Thereviewprocessshallincludetheevaluationof:

• previousmanagementreviewdocuments,actionplansandtimeframes

• resultsofinternal,second-partyandthird-partyaudits

• customerperformanceindicators,complaintsandfeedback

• reviewofthehazardandriskmanagement(HARM)system

• incidents,correctiveactions,out-of-specificationresultsandnon-conformingmaterials

• resourcerequirements

• thesite’sperformanceagainsttheStandardandtheobjectivesset

• theeffectivenessofrootcauseanalysisandcorrectiveactions.

1.2.3 Themeetingshallbedocumentedandusedtorevisetheobjectives.Thedecisionsandactionsagreedwithinthereviewprocessshallbeeffectivelycommunicatedtoappropriatestaff,andactionsimplementedwithinagreedtimescales.

1.2.4 Thesiteshallhaveademonstrablesysteminplacewhichenablesproductsafety,legalityandqualityissuestobebroughttotheattentionofseniormanagementandallowsfortheresolutionofissuesrequiringimmediateaction.


Notes

1.3 Organisationalstructure,responsibilitiesandmanagementauthority

SOI Thecompanyshallhaveaclearorganisationalstructureandlinesofcommunicationtoenableeffectivemanagementofproductsafety,legality,regulatorycomplianceandquality.

1.3.1 Thesiteshallhaveacurrentorganisationchartdemonstratingthemanagementstructureofthecompany.

Theresponsibilitiesforthemanagementofactivitieswhichensureproductsafety,qualityandlegalityshallbeclearlyallocatedandunderstoodbythemanagersresponsible.Itshallbeclearlydocumentedwhodeputisesintheabsenceoftheresponsibleperson.

1.3.2 ClearcommunicationandreportingchannelsshallbeinplacetoreportonandmonitorcompliancewiththeStandard.

1.3.3 Thesite’sseniormanagementshallensurethatallemployeesareawareoftheirresponsibilities.Wheredocumentedworkinstructionsexistforactivitiesundertaken,therelevantemployeesshallhaveaccesstotheseandbeabletodemonstratethatworkiscarriedoutinaccordancewiththeinstructions.

Notes

1.4 Businessrecoveryplan

SOI Thecompany’sseniormanagementshallensurethatthecontinuingoperationofthecompanyisassuredthroughabusinessrecoveryplan

9.1.4.1 Electronicfiles,records,dataandsystemsshallbesuitablyprotectedandbackedup.

Atestofthesystemshallbecarriedoutatleastonceperyear,orwhenanysignificantchangesaremadetothesystem.

2 Hazardandriskmanagementsystem

2.1 Hazardandriskmanagementteam

SOI Amultidisciplinaryhazardandriskmanagementteamshallbeinplacetodevelopandmanagethehazardandriskmanagementsystemandensurethesystemisfullyimplementedandevaluatedforitseffectiveness.

2.1.1 Thehazardandriskmanagementsystemshallbedeveloped,reviewedandmanagedbyamultidisciplinaryteamthatincludesthoseresponsibleforquality,technical,engineering/maintenance,productionoperationsandotherrelevantfunctions.

Intheeventthatthesitedoesnothavetheappropriateexpertisein-house,externalexpertisemaybeusedtoanalyseanyhazardsandtheriskofthemoccurring,and/or


developandreviewthehazardandriskmanagementsystem.However,theday-to-daymanagementofthesystemshallremaintheresponsibilityofthesite.

2.1.2 Themultidisciplinaryteamshallhaveadesignatedteamleaderwhoshallbesuitablytrainedandabletodemonstratecompetenceandexperienceofhazardandriskanalysis.

2.1.3 Theteamshallbeabletodemonstratecompetenceinhazardandriskanalysisprinciplesandbekeptuptodatewithfactorychangesandcustomerrequirementsastheyoccur.

Notes

2.2 Hazardandriskanalysis

SOI Adocumentedhazardandriskmanagementsystemshallbeinplacetoensurethatallhazardstoproductsafety,qualityandlegalityareidentifiedandappropriatecontrolsestablished.

2.2.1 Thescopeofthehazardandriskanalysisshallbeclearlydefinedanddocumentedandshallcoverallproductsandprocessesincludedwithintheintendedscopeofcertification.

2.2.2 Thehazardandriskanalysisteamshallmaintainawarenessofandtakeintoaccount:

• historicalandknownhazardsassociatedwithspecificprocesses,rawmaterialsorintendeduseoftheproduct(whereknown)

• knownlikelyproductdefectsthataffectsafetyorquality

• relevantcodesofpracticeorrecognisedguidelines

• legislativerequirements.

2.2.3 Afulldescriptionoftheproductshallbedeveloped,whichincludesallrelevantinformationonproductsafety,qualityandintegrity.Asaguidethismayinclude:

• composition(e.g.rawmaterials,inks,varnishes,coatingsandotherprintchemicals)

• originofrawmaterials,includinguseofrecycledmaterials

• intendeduseofthepackagingmaterialsanddefinedrestrictionsonuse;forexample,directcontactwithfoodorotherhygiene-sensitiveproducts,orthephysicalorchemicalconditions.

2.2.4 Aflowdiagramshallbepreparedforeachproduct,productgrouporprocess.Thisshallsetouteachprocessstepfromthereceiptofrawmaterialstodispatchtothecustomer.Asaguidethisshallinclude,asrelevant:

• receiptandapprovalofartwork

• receiptandpreparationofrawmaterialssuchasadditives,inksand


adhesives

• eachmanufacturingprocessstep

• in-linetestingormeasuringequipment

• theuseofreworkandpost-consumerrecycledmaterials

• anysubcontractedprocesses

• customerreturns.

Theaccuracyoftheprocessflowshallbevalidatedbythehazardandriskanalysisteam.

2.2.5 Thehazardandriskanalysisteamshallidentifyandrecordallpotentialhazardsthatarereasonablyexpectedtooccurateachstepinrelationtotheproductandprocess.Thehazardsconsideredshallinclude,whererelevant:

• microbiological

• foreignobjects

• chemicalcontamination(e.g.taint,odour,allergen,componenttransferfrominks,varnishesandglues)

• potentialproblemsarisingfromtheuseofrecycledmaterials

• legality

• defectscriticaltoconsumersafety

• hazardsthatmayhaveanimpactonthefunctionalintegrityandperformanceofthefinalproductinuse

• potentialforunintendedmigrationofsubstancesfromthepackagingmaterialintofoodorotherhygiene-sensitiveproduct

• potentialformaliciousintervention.

2.2.6 Thehazardandriskanalysisteamshallidentifycontrolmeasuresnecessarytoprevent,eliminateorreduceeachhazardtoacceptablelevels.

Controlsforidentifiedhazardstoproductqualityshallbeappropriatelymanagedthroughtheprerequisiteprogramme,assetoutinsection5.

Wherecontrolisthroughprerequisiteprogrammestheseshallbereviewedtoensuretheyadequatelycontroltheriskidentifiedand,wherenecessary,improvementsimplemented.

2.2.7 Foreachhazardthatrequirescontrol,otherthanbyanexistingprerequisiteprogramme(assetoutinsections4–6),thecontrolpointsshallbereviewedtoidentifythosethatarecritical.Thisprocessshallincludeanassessmentoftherisklevelforeachhazardbasedonthelikelihoodoftheoccurrenceandtheseverityoftheoutcome.

Criticalcontrolpointsshallbethosecontrolpointsthatarerequiredtoprevent,eliminateorreduceaproductsafetyorintegrityhazardtoacceptablelevels.

Whereacontrolpointisnotclassifiedascriticalandcontrolmaybeachievedthroughaprerequisiteprogramme,aprogrammeshallbedevelopedthatissufficientlyspecifiedtoeffectivelycontroltheidentifiedhazard(s).

2.2.8 Foreachcriticalcontrolpoint,theappropriatecriticallimitsshallbedefinedinordertoidentifyclearlywhethertheprocessisinoroutofcontrol.Criticallimitsshallbe


measurable,wherepossible,andtherationalefortheirestablishmentclearlydocumented.Relevantlegislationandcodesofpracticeshallbetakenintoaccountwhenestablishingthelimits.

2.2.9 Foreachcriticalcontrolpoint,amonitoringsystemshallbedefinedinordertoensurecompliancewithcriticallimits.Recordsofthemonitoringshallbemaintained.DocumentedproceduresrelatingtothemonitoringofcriticalcontrolsshallbeincludedininternalauditsagainsttheStandard(seeclause3.3).

2.2.10 Thecorrectiveactionthatshallbetakenwhenmonitoredresultsindicateafailuretomeetthecontrollimitshallbeestablishedanddocumented.Thisshallincludetheproceduresforquarantiningandevaluatingpotentiallyout-of-specificationproductstoensuretheyarenotreleaseduntiltheirsafety,qualityandlegalitycanbeestablished.

2.2.11 Areviewofthehazardandriskmanagementsystemandprerequisiteprogrammesshallbecarriedoutatleastonceperyearandfollowinganysignificantincidentsorwhenanyprocesschanges.

Thereviewshallincludeaverificationthatthehazardandriskanalysisplaniseffectiveandmayincludeareviewof:

• processchanges

• productcompositionchanges

• complaints

• productfailures

• finishedproductrecallsfromconsumers(includingsystemtests)

• productwithdrawals

• resultsofinternalauditsofprerequisiteprogrammes

• resultsfromexternalandthird-partyauditors

• newdevelopmentsinindustryassociatedwithmaterials,processorproduct.

Notes

2.3 Exemptionofrequirementsbasedonriskanalysis

SOI Thehazardandriskanalysisstudyshallbefullysupportedbytheimplementationoftheprerequisitessetoutinrequirementsclauses4to6.However,thehazardandriskanalysismayindicatethatsomeoftherequirementsmaybeexempted.

2.3.1 Exemptionsshallbedocumentedandregardedasproposedexemptionsforreviewataudit.Acceptanceorrejectionoftheproposedexemptionsshallberecordedintheauditor’sreport.

2.3.2 ThesiteshallkeeprecordedexemptionstotheStandardunderreviewandprovide


documentedevidenceofthisreviewatsubsequentaudit.

Notes

3 Productsafetyandqualitymanagement

3.1 Productsafetyandqualitymanagementsystem

SOI Thesite’sprocessesandprocedurestomeettherequirementsofthisStandardshallbedocumentedtoallowconsistentapplication,facilitatetraining,andsupportduediligenceintheproductionofasafeandlegalproduct.

3.1.1 Thesite’sdocumentedprocedures,workingmethodsandpracticesshallbecollatedinanavigableandreadilyaccessiblesystem,withconsiderationbeinggiventotranslationintoappropriatelanguages.

3.1.2 Thesystemshallbefullyimplemented,reviewedatappropriateplannedintervalsandimprovedwherenecessary.

9.3.1.3 Thesiteshalldefineanddocumenthownewprocedures,workingmethodsandpracticesarecommunicatedtorelevantpersonnel.

Notes

3.2 DocumentationControl

SOI Aneffectivedocumentcontrolsystemshallensurethatonlythecorrectversionsofdocuments,includingrecordingforms,areavailableandinuse.

3.2.1 Thecompanyshallhaveadocumentedproceduretomanagedocumentswhichformpartoftheproductsafetyandqualitysystem.Thisshallinclude:

• alistofallcontrolleddocumentsindicatingthelatestversionnumber

• themethodfortheidentificationandauthorisationofcontrolleddocuments

• arecordofthereasonforanychangesoramendmentstodocuments

• thesystemforthereplacementofexistingdocumentswhentheseareupdated.

3.2.2 Wheredocumentsandrecordsareinelectronicformtheseshallbesuitablyprotectedtopreventlossormaliciousintervention.


Notes

3.3 Recordkeeping

SOI Thesiteshallmaintaingenuinerecordstodemonstratetheeffectivecontrolofproductsafety,legalityandquality.

3.3.1 Recordsshallbelegible,appropriatelyauthorised,retainedingoodcondition,andretrievable.Whererecordsareinelectronicformtheseshallbesuitablybackeduptopreventloss.

3.3.2 Anyalterationstorecordsshallbeauthorisedandjustificationforthealterationshallberecorded.

3.3.3 Thecompany’sseniormanagementshallensurethatdocumentedproceduresareestablishedandimplementedfortheorganisation,review,maintenance,storageandretrievalofallrecordsrelatingtoproductsafety,legality,regulatorycomplianceandquality.

3.3.4 Theperiodofretentionforrecordsshallrelatetotheusablelifeofthepackagingandproductsitisdesignedtocontainandshallrespectanycustomerrequirements.

9.3.3.5 ApolicyshallstatethatProductionrecordsandallotherrecordsassociatedwithproductsafety,qualityandlegalityshallbewrittenindelibly.Anyalterationstorecordsshallbeauthorisedandjustificationforthealterationshallberecorded.

Notes

3.4 Specifications

SOI Appropriatespecificationsshallexistforrawmaterials,intermediateandfinishedproducts,andforanyproductorservicewhichcouldaffectthequalityofthefinishedproductandcustomerrequirements.

3.4.1 Specificationsshallbesuitablydetailedandaccurate,andshallensurecompliancewithrelevantproductsafetyandlegislativerequirements.

3.4.2 Thecompanyshallseekformalagreementofspecificationswithrelevantparties.Wherespecificationsarenotformallyagreedthenthecompanyshallbeabletodemonstratethattheyhavetakenstepstoputanagreementinplace.


3.4.3 Adeclarationofcomplianceshallbemaintainedwhichenablesusersofthepackagingmaterialstoensurecompatibilitybetweenthosematerialsandtheproductwithwhichtheymaybeincontact.

Thedeclarationofcomplianceshallcontainasaminimum:

• thenatureofthematerialsusedinthemanufactureofthepackaging

• confirmationthatthepackagingmaterialsmeetrelevantlegalrequirements

• theinclusionofanypost-consumerrecycledmaterials.

Thisshallidentifyanylimitationsofuseoftheproductandtheusablelifeofthepackagingmaterial(whererelevant).

Productsshallmeetatleastminimumlegalrequirementsinthecountryofmanufacture,anduse,whereknown.

3.4.4 Thepresenceofmanufacturer’strademarksorlogoonpackagingmaterialsshall,whereappropriate,beformallyagreedbetweenrelevantparties.

3.4.5 Aspecificationreviewprocessshallbeoperatedwhereproductcharacteristicschangeoratanappropriatepredeterminedinterval.

3.4.6 Wherespecificationsareinelectronicformtheseshallbesuitablyprotectedtopreventlossormaliciousintervention.

Notes

3.5 Internalaudits

SOI ThecompanyshallbeabletodemonstratethatitverifiestheeffectiveapplicationoftherequirementsoftheGlobalStandardforPackagingandPackagingMaterialsthroughinternalaudits.

3.5.1 Thereshallbeascheduledprogrammeofinternalauditsthroughouttheyearwithascopewhichcoversthehazardandriskmanagementsystem,prerequisiteprogrammesandallproceduresthathavebeenimplementedtoachievethisStandard.Allactivitiesshallbecoveredatleastannually.

Theinternalauditprogrammeshallbefullyimplemented.

3.5.2 Thescopeandfrequencyoftheauditsshallbeestablishedinrelationtotherisksassociatedwiththeactivityandpreviousauditperformance.

3.5.3 Internalauditsshallbecarriedoutbyappropriatelytrained,competentauditors.Auditorsshallbesufficientlyindependentfromtheprocessbeingauditedtoensureimpartiality(i.e.theymustnotaudittheirownwork).

3.5.4 Internalauditreportsshallidentifyconformityaswellasnon-conformity.

Resultsshallbenotifiedtothepersonnelresponsiblefortheprocessaudited.Root


causeanalysisshallbeusedtodetermineappropriatecorrectiveactions.Correctiveactionsandtimescalesfortheirimplementationshallbeagreedandcompletionoftheactionsverified.

Notes

3.6 Supplierapprovalandperformancemonitoring

SOI Thecompanyshalloperateeffective,documentedproceduresforapprovalandmonitoringofitssuppliers.

3.6.1 Thesiteshallhaveadocumentedsupplierapprovalprocedureandcontinualassessmentprogrammeinplace,baseduponriskanalysis.Theseshallapplytosuppliersof:

• materials

• subcontractedprocesses

tothesiteandensurethatmaterialsandservicesprocuredconformtodefinedrequirements,wherethereisapotentialimpacttoproductsafety,qualityorlegality.

3.6.2 Theproceduresshallincludeclearcriteriafortheassessmentandapprovalofnewsuppliers.Assessmentmaytaketheformof:

• suppliercertificationwithascopecoveringtheproductssupplied(e.g.againsttheappropriateBRCGlobalStandard,orotherGFSIbenchmarkedscheme)

• supplierquestionnaires

• supplieraudits.

Thesiteshallhaveanup-to-datelistofapprovedsuppliers.

3.6.3 Recordsofsupplierassessmentandnecessaryactionsshallbemaintainedandreviewed.

3.6.4 Theproceduresshalldefinehowexceptionsarehandled;forexample,theuseofproductsorserviceswhereauditormonitoringhasnotbeenundertaken.Assessment(onabatchordeliverybasis)maytaketheformof:

• certificateofanalysis

• declarationofcompliance.


Notes

3.7 Managementofsubcontractedprocesses

SOI Whereanyprocessstepsinthemanufactureofthepackagingmaterialaresubcontractedtoathirdpartyorundertakenatanothersite,thisshallbemanagedtoensureitdoesnotcompromisethequality,safetyorlegalityoftheproduct.

3.7.1 TheuseofsubcontractorsandthestatusofthesubcontractorwithrespecttotheStandardshallbenotifiedtothebrandownerand/orcustomer.

3.7.2 Whereanyprocessesaresubcontracted,includingartworkorpre-pressactivity,theriskstothequalityandsafetyoftheproductshallformpartofthehazardandriskanalysisandthecompany’sevaluationofthesystemshallbeheldonrecord.

3.7.3 Clearspecificationsshallbeagreedforallworkoutsourcedtoasubcontractor.

3.7.4 Whereanyprocessstepsinthemanufactureofthepackagingorpackagingmaterialaresubcontracted,finalreleaseoftheproductshallremaintheresponsibilityofthesite.

Controlsshallbeinplaceforchecksonfinishedworktoensureproductsafetyandqualitymeetsspecificationpriortodispatchtothefinalcustomer.

Notes

3.8 Managementofsuppliersofservices

SOI Thecompanyshallbeabletodemonstratethatwhereservicesareoutsourced,theserviceisappropriateandanyriskspresentedtoproductsafety,qualityorlegalityhavebeenevaluatedtoensureeffectivecontrolsareinplace

3.8.1 Thereshallbeadocumentedprocedurefortheapprovalandmonitoringofsuppliersofservices.Suchservicesmayinclude,butarenotlimitedto:

• pestcontrol

• laundryservices

• transportanddistribution

• storageanddispatch


• sortingorrework

• laboratoryservices

• calibrationservices

• wastemanagement.

Providersofutilitiessuchaswater,electricityorgasmaybeexcludedonthebasisofrisk.

3.8.2 Documentedagreementsshallexistwiththesuppliersofserviceswhichclearlydefineserviceexpectationsandensurepotentialrisksassociatedwiththeservicehavebeenaddressed.

Notes

3.9 Traceability

SOI Thesiteshallbeabletotraceandfollowallrawmaterialsthroughprocessingtothedistributionofthefinishedproduct(packagingmaterial)tothecustomerandviceversa.

3.9.1 Thesiteshallhaveasystemwhichhastheabilitytotraceandfollowallrawmaterialsfromthesupplierthroughallstagesofprocessinganddistributionofthefinishedproductandviceversa.Wherecontinuousprocessesareusedorrawmaterialsareinbulksilos,traceabilityshallbeachievedtothebestpracticallevelofaccuracy.

3.9.2 Identificationofrawmaterials,intermediateproducts,finishedproducts,non-conformingproductandquarantinedgoodsshallbeadequatetoensuretraceability.

3.9.3 Anappropriatesystemshallbeinplacetoensurethecustomercanidentifyaproductorproductionlotnumberfortheproduct,forthepurposesoftraceability.

3.9.4 Thesystemshallbetestedtoensuretraceabilitycanbedeterminedfromrawmaterialstothefinishedproductandviceversa.Recordsshallberetrievableinatimelymanner.

Thisshalltakeplaceonapredeterminedfrequency,atleastonanannualbasis,andresultsretainedforinspection.

3.9.5 Wherereworkoranyreworkingoperationisperformed,traceabilityshallbemaintained.


Notes

3.10 CustomerFocusandContractReview

SOI Thecompany’sseniormanagementshallensurethatprocessesareinplacetodeterminecustomerneedsandexpectationswithregardtoquality,safetyandlegality,andensurethesearefulfilled.

3.10.1 Thecompanyshallclearlyidentifythosejobtitlesresponsibleforcommunicationwithcustomersandshallhaveaneffectivesystemforcommunication.

3.10.2 Customerneedsandexpectationsshallbedocumentedandreviewedonasuitablefrequency.Anychangestoexistingagreementsorcontractsshallbeagreed,documentedandcommunicatedtoappropriatedepartments.

3.10.3 Wherecustomershavesetparticularperformancecriteriaorindicatorsformonitoring,theserequirementsshallbecommunicatedtorelevantstaff,adheredto,andreviewedatappropriateintervals.

Notes

3.11 Complainthandling

SOI Customercomplaintsrelatingtoproducthygiene,safetyorqualityshallbehandledeffectivelyandtheinformationusedtoreducecomplaintlevels.

3.11.1 Allcomplaintsshallberecordedandinvestigated(includingrootcauseanalysis)andtheresultsoftheinvestigationdocumented.

Actionsappropriatetotheseriousnessandfrequencyoftheproblemsidentifiedshallbecarriedoutpromptlyandeffectivelybyappropriatelytrainedstaff.

3.11.2 Complaintdatashallbeanalysedtoidentifysignificanttrends.Wheretherehasbeenanincreaseorrepetitionofacomplainttype,rootcauseanalysisshallbeusedtoimplementongoingimprovementstoproductsafety,legalityandquality,andtoavoidrecurrence.Thisanalysisshallbemadeavailabletorelevantstaff.

9.3.11.3 Allcomplaintsregardingrawmaterialdefectsidentifiedbythesiteshallberecordedandinvestigated(includingrootcauseanalysis)andtheresultsoftheinvestigationdocumented.


Notes

3.12 Managementofproductwithdrawals,andincidentsandproductrecalls

SOI Thesiteshallhaveaplanandsystemsinplacetoeffectivelymanageanyproductwithdrawalsorreturnsfromcustomers,incidentsandproductrecallsinordertoensurethatallpotentialriskstothehygiene,quality,safetyorlegalityofproductsandthefinalconsumerarecontrolled.

3.12.1 Aproductwithdrawalprocedureshallbedocumentedandshallincludeasaminimum:

• identificationofthekeypersonnelinvolvedinassessingpotentialproductwithdrawalsorreturns,withtheirresponsibilitiesclearlydefined

• acommunicationsplanincludingmethodsofinformingcustomers

• rootcauseanalysisandcorrectiveactiontoimplementappropriateimprovementsasrequired.

3.12.2 Thewithdrawalprocedureshallbecapableofbeingoperatedatanytimeandwilltakeintoaccountnotificationtothesupplychain,stockreturn,logisticsforrecovery,storageofrecoveredproductanddisposal.

3.12.3 Thedesignatedmanagershallberesponsibleforensuringthatrootcauseanalysisisusedtodetermineandimplementpreventiveactionandimprovementsasnecessary.

3.12.4 Thecompanyshallprovidewrittenguidanceandtrainingforrelevantstaffregardingthetypeofeventthatwouldconstituteanincident.Adocumentedincidentreportingprocedureshallbeinplace.

3.12.5 Thecompanyshalldetermineanddocumenttheactivityrequiredtoeffectivelymanageanincidenttopreventreleaseofproductwherehygiene,safetyorqualitymayhavebeenaffected.

3.12.6 Aproceduretomanageproductrecallsinitiatedbythebrandownerorspecifiershallbedocumentedandshallincludeasaminimum:

• identificationofthekeypersonnelinvolvedinassessingpotentialrecalls,togetherwithclearlydefinedresponsibilities

• acommunicationsplanthatincludesmethodsofinformingcustomersand(wherenecessary)regulatorybodiesinatimelymanner

• correctiveactionandbusinessrecovery

• reviewofanyrecallsinordertoconductrootcauseanalysisandimplementappropriateimprovementsasrequired.

3.12.7 Whereasite’sproductsareinvolvedinaproductrecall,thesiteshallassistwithprovisionofinformation(suchastraceability)asrequired.


3.12.8 Theproductwithdrawalprocedureshallbetested,atleastannually,inawaythatensuresitseffectiveoperation.Resultsofthetestshallberetainedandshallincludetimingsofkeyactivities.

Theresultsofthetest,andofanyactualwithdrawals,shallbeusedtoreviewtheprocedureandimplementimprovementsasnecessary.

Notes

4 SiteStandards

4.1 Externalstandards

SOI Thesiteshallbeofsuitablesizeandconstruction,inasuitablelocation,andmaintainedtoanappropriatestandardtoreducetheriskofcontaminationandfacilitatetheproductionofsafeandlegalproducts.

4.1.1 Considerationshallbegiventolocalactivitiesandthesiteenvironment,whichmayhaveanadverseimpactonthesafetyorqualityofthefinishedproductorrawmaterials,andmeasuresshallbetakentopreventcontamination.Wheremeasureshavebeenputinplacetoprotectthesite,theyshallberegularlyreviewedtoensuretheycontinuetobeeffective(e.g.floodcontrols).

4.1.2 Theexternalareasshallbemaintainedingoodorder.Anygrassedorplantedareassurroundingbuildingsshallberegularlytendedandwellmaintained.Externaltrafficroutesundersitecontrolshallbesuitablysurfacedtoavoidcontaminationoftheproduct.

4.1.3 Thebuildingfabricshallbemaintainedtominimisepotentialforpestentry,ingressofwaterandothercontaminants.Externalsilos,pipeworkorotheraccesspointsfortheproductand/orrawmaterialsshallbeappropriatelysealedandsecured.Wherepossible,acleanandunobstructedareashallbeprovidedalongtheexternalwallsofthebuildingsusedforproductionand/orstorage.

4.1.4 Wherenaturalexternaldrainageisinadequate,additionaldrainageshallbeinstalled.Drainsshallbeproperlyprotectedtoprevententryofpests.

4.1.5 Whereexternalstorageofrawmaterialsisnecessary,theseshallbeprotectedinordertominimisetheriskofcontamination.

9.4.1.6 Whereproductionandstorageareasaresurroundedbygrassedorplantedareas,thereshallbeavegetationfreezonearoundthebuildings.


Notes

4.2 Buildingfabricandinteriors

SOI Theinternalsite,buildingsandfacilitiesshallbesuitablefortheintendedpurposeandshallbedesigned,constructed,maintainedandmonitoredtoeffectivelycontroltheriskofproductcontamination.

4.2.1 Walls,floors,ceilingsandpipeworkshallbemaintainedingoodconditionandshallfacilitatecleaning.

4.2.2 Wheresuspendedceilingsexisttheyshallbeconstructed,finishedandmaintainedtopreventtheriskofproductcontamination,andaccessibleforcleaningandinspectionforpestsunlessthevoidisfullysealed.

4.2.3 Allinternaldrainopeningsshallbesuitablyprotectedagainsttheentryofpestsanddesignedtominimiseodour.

4.2.4 Wheretheyconstitutearisktoproduct,andbasedonthelikelihoodandriskofcontamination,windowsandroofglazingshallbeprotectedagainstbreakage.

4.2.5 Wheretheyconstitutearisktoproduct,andbasedonthelikelihoodandriskofnon-productionglasscontamination,allbulbsandstriplights,includingthoseonflying-insectcontroldevices,shallbeadequatelyprotected.

4.2.6 Suitableandsufficientlightingshallbeprovidedtoensureasafeworkingenvironment,correctoperationofprocesses,effectiveinspectionoftheproductandcleaning.

4.2.7 Suitableandsufficientventilationshallbeprovided.

Notes

4.3 Utilities

SOI Allutilitiestoandwithintheproductionandstorageareasshallbedesigned,constructed,maintainedandmonitoredtoeffectivelycontroltheriskofproductcontamination.

4.3.1 Allwaterusedintheprocessingoftheproductsorequipmentcleaningshallbe


potableorsuitablytreatedtopreventcontamination.

4.3.2 Basedonriskassessment,themicrobiologicalandchemicalqualityofwater,steam,ice,air,compressedairorothergaseswhichcomeintodirectcontactwithpackagingshallberegularlymonitored.Theseshallpresentnorisktoproductsafetyorqualityandshallcomplywithrelevantlegalregulations.

Notes

4.4 Security

SOI Securityarrangementsshallbeassessedtoensuretheintegrityofproductsandprocesses.

4.4.1 Thecompanyshallundertakeadocumentedriskassessmentofthesecurityarrangementsandpotentialriskstotheproductsfromanydeliberateattempttoinflictcontaminationordamage.Areasshallbeassessedaccordingtorisk;sensitiveorrestrictedareasshallbedefined,clearlymarked,monitoredandcontrolled.

Identifiedsecurityarrangementstoreducerisksshallbedocumented,implementedandreviewedatleastannually.

4.4.2 Measuresshallbeinplacetoensureonlyauthorisedpersonnelhaveaccesstoproductionandstorageareas,andaccesstothesitebyemployees,contractorsandvisitorsshallbecontrolled.

Avisitorreportingsystemshallbeinplace.Staffshallbetrainedinsitesecurityproceduresandencouragedtoreportunidentifiedorunknownvisitors.

4.4.3 Externalstoragetanks,silosandanyintakepipeswithanexternalopeningshallbesufficientlysecuretopreventunauthorisedaccess.

Notes

4.5 Layoutandproductflow

SOI Thefactorylayout,flowofprocessesandmovementofpersonnelshallbesufficienttopreventtheriskofproductcontaminationandtocomplywithallrelevantlegislation.

4.5.1 Thereshallbeaplanofthesitewhichdefines:


• accesspointsforpersonnel

• travelroutes

• stafffacilities

• processflow

• storageareas.

4.5.2 Theprocessflowfromintaketodispatchshallbearrangedtominimisetheriskofcontaminationordamagetotheproduct.

4.5.3 Premisesshallallowsufficientworkingspaceandstoragecapacitytoenablealloperationstobecarriedoutproperlyundersafeandhygienicconditions.

4.5.4 Sortingorotheractivitiesinvolvingthedirecthandlingoftheproductshalltakeplaceinareasthathave,asaminimum,thesamestandardsasproductionareas.

4.5.5 Activitiesthatcouldproduceacontaminationrisk,suchastheremovalofouterpackaging,shallbecarriedoutinadesignated,segregatedarea.

4.5.6 Ifitisnecessarytoallowaccessthroughproductionareas,designatedwalkwaysshallbeprovidedthatensurethereisadequatesegregationfrommaterials.

4.5.7 Wherepossible,allfacilitiesshallbedesignedandpositionedsothatmovementofpersonnelisbysimple,logicalroutes.

Notes

4.6 Equipment

SOI Equipmentshallbesuitablydesignedfortheintendedpurposeandshallbemaintainedandusedsoastominimisetherisktoproductsafety,legalityandquality.

4.6.1 Equipmentshallbedesignedfortheintendedpurposeandshallminimisetheriskofcontaminationtotheproduct.

Equipmentshallbeconstructedofsuitablematerialsandbedesignedtoensureitcanbeeffectivelycleanedandmaintained.

4.6.2 Newlyinstalledequipmentshallbeproperlyspecifiedbeforepurchase.Newequipmentshallbetestedandcommissionedpriortouseandamaintenanceandcleaningprogrammeestablished.

4.6.3 Woodenequipmentincludingdesks,chairs,tables,etc.shallbeproperlysealedtoenableeffectivecleaning.Thisequipmentshallbekeptclean,ingoodconditionandfreefromsplintersorothersourcesofphysicalcontamination.

4.6.4 Noticesonequipmentshallbecleanableandsecure.


9.4.6.5 Lubricationpointsandapplicationmethodsofanylubricantshallnotbeabletocontaminatetheproduct.

Notes

4.7 Maintenance

SOI Aneffectivemaintenanceprogrammeshallbeinoperationforplantandequipmenttopreventcontaminationandreducethepotentialforbreakdowns.

4.7.1 Adocumentedprogrammeofmaintenanceshallbeoperated,coveringallitemsofproductionequipmentandplant,topreventcontaminationandreducetheriskofbreakdown.

4.7.2 Acondition-basedorpreventivemaintenanceprogrammeshallbeinplace,coveringallitemsofequipmentandplantthatarecriticaltoproductsafety,legalityandquality.

4.7.3 Inadditiontoanyplannedmaintenanceprogramme,wherethereisariskofproductcontaminationbyforeignbodiesarisingfromequipmentfailureordamage,theequipmentshallbeinspectedatpredeterminedintervals,inspectionresultsdocumentedandappropriateactiontaken.

4.7.4 Maintenanceworkshallnotplaceproductsafety,qualityorlegalityatrisk.Maintenanceworkshallbefollowedbyadocumentedclearanceprocedurewhichrecordsthatcontaminationhazardshavebeenremovedandequipmentclearedtoresumeproduction.

4.7.5 Toolsandothermaintenanceequipmentshallbeclearedawayafteruseandappropriatelystored.

4.7.6 Temporaryrepairs/modificationsusingtape,cardboard,etc.,shallonlybepermittedinemergenciesandwhereproductcontaminationisnotatrisk.Suchmodificationsshallbesubjecttoatimelimitandshallberecordedandscheduledforcorrection.

4.7.7 Engineeringworkshopsshallbecontrolledtopreventtransferofengineeringdebristoproductionorstorageareas(e.g.byprovisionofswarfmats).

4.7.8 Contractorsinvolvedinmaintenanceorrepairshallbesuitablymonitoredbyastaffmemberwhoshallberesponsiblefortheiractivities.


Notes

4.8 Housekeepingandcleaning

SOI Housekeepingandcleaningsystemsshallbeinplacewhichensurethatappropriatestandardsofhygienearemaintainedandthatriskofcontaminationtotheproductisminimised.

4.8.1 Goodstandardsofhousekeepingshallbemaintained,whichshallincludea‘cleanasyougo’policy.

4.8.2 Documentedcleaningproceduresshallbeinplaceandmaintainedforbuildings,equipmentandvehicles.Thefrequencyandmethodsofcleaningshallbebasedonrisk.Cleaningschedulesandproceduresshallincludethefollowinginformation:

• responsibilityforcleaning

• item/areatobecleaned

• frequencyofcleaning

• methodofcleaning

• cleaningmaterialstobeused

• cleaningrecordandresponsibilityforverification.

4.8.3 Cleaningchemicalsshallbefitforpurpose,suitablylabelled,andusedinaccordancewithmanufacturers’instructions.Theyshallbestoredinasecured,designatedlocation,inclosedcontainers.Chemicalsthatarestronglyscentedorcouldgiverisetotaintandodourcontaminationshallnotbeused.

Cleaningequipmentshallbekeptinasuitabledesignatedlocation.

4.8.4 Materialsandequipmentusedforcleaningtoiletsshallbesegregatedfromthoseusedelsewhere.

9.4.8.5 Theconditionsrequiredinproductionandstorageareasshallbespecified.Thereshallbearegulardocumentedcheckthatconditionsmatchthoserequired,andactivityundertakenwhererequired.

9.4.8.6 Thesiteshallensurethatequipment,in-processandfinishedarticlesaresubjecttosufficientsegregationtoreducetheriskofmixing.


Notes

4.9 Productcontaminationcontrol

SOI Allpracticablestepsshallbetakentoidentify,eliminate,avoidorminimisetheriskofforeignbodyorchemicalcontamination.

4.9.1 Glass,brittleplastics,ceramicsandsimilarmaterialscontrol

4.9.1.1 Thereshallbenounnecessarynon-productionglass,ceramicsorbrittleplastic,whichmayposeariskofcontamination.

4.9.1.2 Allglassorbrittleplasticsotherthantheproductshallbecontrolledandrecordedonaregisterwhichshallincludeasaminimum:

• alistofitemsdetailinglocation,number,typeandcondition

• recordedchecksofconditionofitems,carriedoutataspecifiedfrequencythatisbasedonthelevelofrisktotheproduct

• detailsoncleaningorreplacingitemstominimisepotentialforproductcontamination.

Glassorbrittleplasticsnotintheproductionorstorageareasshallbeincludedintheregisteronthebasisofrisk.

4.9.1.3 Wherenon-productionglassorbrittleplasticbreakageoccurs,aresponsiblepersonshallbeplacedinchargeoftheclean-upoperationandshallensurethatnootherareaisallowedtobecomecontaminatedduetothebreakage.Anyproductthathasbecomecontaminatedshallbesegregatedanddisposedof.

Allbreakagesshallberecordedinanincidentreport.

Notes

4.9.2 Sharpscontrol

4.9.2.1 Thereshallbeadocumentedpolicyforthecontroloftheuseofsharps.

4.9.2.2 Sharpblades,equipmentandtoolsshallnotbeleftinapositionthatallowsthemtocontaminatetheproduct.

4.9.2.3 Sharpcuttinginstrumentsusedinthemanufactureofpackagingmaterialsshallbe


controlledtopreventproductcontamination.Thisshallincludecontrolintoandoutofthefactory.

4.9.2.4 Snap-offbladeknivesshallnotbeused.

4.9.2.5 Whereopennoticeboardsarepresentinproduction,packingandstorageareas,loosefastenings,suchasdrawingpinsandstaples,shallnotbeused.

Notes

4.9.3 Chemicalandbiologicalcontrol

4.9.3.1 Processesshallbeinplacetomanagetheuse,storageandhandlingofnon-productionchemicals,topreventchemicalcontamination.Theseshallincludeasaminimum:

• alistofapprovedchemicalsforpurchase

• availabilityofmaterialsafetydatasheetsandspecifications

• avoidanceofstronglyscentedproducts

• thelabellingand/oridentificationofcontainersofchemicalsatalltimes

• designatedstorageareawithaccessrestrictedtoauthorisedpersonnel

• usebytrainedpersonnelonly.

4.9.3.2 Hazardandriskanalysisshallbeusedtoidentify,controlandmanageanypotentialrisksfrommicrobiologicalcontaminationandanypotentialallergens.

Notes

4.10 Wasteandwastedisposal

SOI Suitablefacilitiesshallbeprovidedforthestorageanddisposalofprocessandotherwaste.

4.10.1 Wherelicensingisrequiredbylawfortheremovalofwaste,itshallberemovedbylicensedcontractorsandrecordsofremovalshallbemaintainedandavailableforaudit.

4.10.2 Suitableandsufficientrefuseandwastecontainersshallbeprovided,whichshallbeemptiedatappropriatefrequenciesandmaintainedinanadequatelycleancondition.


4.10.3 Whereappropriate,wasteshallbecategorisedaccordingtolegislativerequirementsbasedontheintendedmeansofdisposal(suchasrecycling),andsorted,segregatedandcollectedinappropriatedesignatedwastecontainers.

4.10.4 Substandardtrademarkedmaterialsshallberenderedunusablethroughadestructiveprocess.Allmaterialsdisposedofshallberecorded.

4.10.5 Ifsubstandardtrademarkedmaterialsaretransferredtoathirdpartyfordestructionordisposal,thatthirdpartyshallbeaspecialistinappropriatewastedisposalandshallproviderecordsofmaterialdestruction.

4.10.6 Externalstorageofrefuseshallbeindesignatedareasanddesignedormaintainedtominimisetheriskofpestharbourage.

Notes

4.11 Pestcontrol

SOI Inordertominimisetheriskofinfestationandpreventrisktoproducts,thewholesiteshallhaveaneffectivepreventivepestcontrolprogrammeinplaceandtheresourcesavailabletorespondimmediatelytoanyissueswhichoccur.

4.11.1 Apreventivepestcontrolprogrammeshallbemaintained,coveringallareasofthesiteunderthesite’scontrol.

4.11.2 Thesiteshalleithercontracttheservicesofacompetentpestcontrolorganisationorshallhaveappropriatelytrainedstafffortheregularinspectionandtreatmentofthesiteinordertodeteranderadicateinfestation.Thefrequencyofinspectionsshallbedeterminedbyriskassessmentandshallbedocumented.Wheretheservicesofapestcontrolcontractorareemployed,theservicecontractshallbeclearlydefinedandreflecttheactivitiesofthesite.

4.11.3 Whereasiteundertakesitsownpestcontrol,itshallbeabletodemonstratethat:

• pestcontroloperationsareundertakenbytrainedandcompetentstaffwithsufficientknowledgetoselectappropriatepestcontrolchemicalsandproofingmethodsandunderstandthelimitationsofuse,relevanttothebiologyofthepestsassociatedwiththesite

• staffundertakingpestcontrolactivitiesmeetanylegalrequirementsfortrainingorregistration

• sufficientresourcesareavailabletorespondtoanyinfestationissues

• thereisreadyaccesstospecialisttechnicalknowledgewhenrequired

• legislationgoverningtheuseofpestcontrolproductsisunderstood

• dedicatedlockedfacilitiesareusedforthestorageofpesticides.

4.11.4 Pestcontrolequipmentsuchasbaitstations,trapsorelectricfly-killingdevicesshall


beappropriatelylocatedandoperational.

4.11.5 Effectiveprecautionsshallbeinplacetopreventpestsenteringthepremises.Thebuildingshallbesuitablyproofedagainsttheentryofallpestsviadoors,windows,ductsandcableentrypoints.

4.11.6 Intheeventofinfestation,immediateactionshallbetakentoeliminatethehazard.Actionshallbetakentoidentify,evaluatethepotentialforcontaminationordamage,andauthorisethereleaseofanyproductpotentiallyaffected.

4.11.7 Intheeventofaninfestation,andatappropriateintervals,thesiteshallrequestacatchanalysisfromflying-insectcontroldevicestohelpidentifyproblemareas.

Intheeventofincreaseinactivity,thesiteshalluseriskassessmenttodeterminetheactivityrequiredtoeliminatethehazard.

4.11.8 Documentedproceduresanddetailedrecordsofpestactivity,pestcontrolinspectionsandrecommendationsshallbemaintained.Theseshallincludeasaminimum:

• anup-to-date,signedandauthorisedsiteplanidentifyingnumberedpestcontroldevicelocations

• identificationofthebaitsand/ormonitoringdevicesonsite

• clearlydefinedresponsibilitiesforsitemanagementandthecontractor

• detailsofpestcontrolproductsusedandinstructionsfortheireffectiveuse

• detailedrecordsofpestcontrolinspections,recommendationsandofanypestinfestation.

Itshallbetheresponsibilityofthesitetoensurethatalltherelevantrecommendationsmadebythecontractororin-houseexpertareimplementedinatimelymannerandmonitoredforefficacy.

4.11.9 Employeesshallunderstandthesignsofpestactivityandbeawareoftheneedtoreportanyevidencetoadesignatedmanager.

9.4.11.10 Thesiteshallassessthesuitabilityofitspestcontrolprogrammetoaddressvariationinpestactivitythroughdifferentseasons,andconsideranyadditionalpreventativeactivityrequired.

Thesiteshalldocumentandimplementthisadditionalactivity.

9.4.11.11 Riskassessmentandongoingdatashouldbeusedtodeterminewhetherlightingtypeorpositioningisadverselyattractinginsectsand/orhighlightinganymitigationwhererequired.

Internalandexternallightingforproductionandstoragebuildingsshallbedesignedandconstructedtoavoidattractinginsectsthroughwindowsorotheropenings.

9.4.11.12 Thesiteshalluseadocumentedriskandongoingassessmenttodetermineifdoubledoorsetsarerequiredwhenmovingfromexternaltointernalareas.

Thesiteshallconductongoingassessmenttodetermineiftheclosingsystemsareeffective,whereimplemented.


Notes

9.4.12 AmbientEnvironment

SOI Thesiteshallensurethatlocalenvironmentalfactorssuchastemperatureandhumiditydonotaffectproductqualityfromrawmaterialstofinishedproducts.

9.4.12.1 Thesiteshallevaluatethetypicallocalenvironmentalconditionssuchastemperatureandhumidityonthequalityandprocesscharacteristics(e.g.machinesettings).Evaluationofhazardsidentifiedshallbedocumented,andmeasuresestablishedtomanagethisimpactshallbedocumentedandvalidated.

5 Productandprocesscontrol

5.1 Productdevelopment

SOI Documentedproductdevelopmentormodificationproceduresshallbeinplacetoensuretheproductionofsafeandlegalproductstodefinedqualityparameters.

5.1.1 Customerrequirementsrelatingtothedesign,development,specification,manufactureanddistributionoftheproductshallbedocumentedandagreedwiththecustomer.

Thisshalltakeintoconsiderationprocessrequirementsandenduse,wherepossible.

Anycritical-useparametersshallbeidentifiedanddefined;forexample,barrierrequirements,max/minusetemperature,machinerunning,useofrecycledmaterials,andtestingrequirements(includingmigration,whererelevant).

Specialattentionshallbepaidtoanymaterialsthatarerequiredorrequestedtobemanufacturedfromrecycledmaterials,toensurethattheyarebothappropriateandlegal.

5.1.2 Thesiteshallclearlydefineanddocumentwhenaproductiontrialisrequired.

Whereappropriate,productiontrialsshallbecarriedoutandtestingshallvalidatethatmanufacturingprocessesarecapableofproducingasafeandlegalproducttotherequiredquality.

5.1.3 Thecompanyshallensurethatproductioniscarriedoutusingdefinedoperatingconditionsthatresultinsafeandlegalproductsoftheprescribedquality.

5.1.4 Atechnicalproductspecificationshallbepreparedand,wherepossible,agreedwiththecustomerorbrandownerbeforetheproductionprocessbegins.

5.1.5 Samplesasagreedwiththespecifiershallberetainedforfuturereference.

9.5.1.6 Adocumentedprocedureshallbeplacetoaddressthetransferofcustomerspecificationtothesite’sownsystems.Thisshallinclude(butisnotlimitedto):


• validationofaccuracyofdatatransferred• howchangestocustomerspecificationsareupdatedandcommunicated• howcustomertestingmethodrequirementsaremet• evaluationofhowchangesmadetocustomerspecificationaffectthe

technicalproductspecification(5.1.1)

9.5.1.7 Newproductsorproductchangesshallbesubjecttosuitabletestingtoensurethatrequiredqualityparameterscanbeachieved.

9.5.1.8 Thesiteshalldeterminetheoutputsandsuccesscriteriarequiredfromaproductiontrial,changesand/oradditionsmadetomaterials,processingcharacteristicsorequipment.

9.5.1.9 Settingsderivedfromsuccessfullyqualifiedproductiontrialsorequipmentinstallationsshallbetransferredaccuratelytoprocesscontroldocumentation.

9.5.1.10 Thesite’stestmethodsusedinbothon-lineandoff-linetestingshallbevalidatedtoensuretheirvalidity,sensitivity,reproducibilityandrange,inadditiontoanyotherrelevantcriteria.

Notes

5.2 Graphicdesignandartworkcontrol

SOI Artworkandallpre-pressprocessesconductedbythesiteshallbemanagedtoensurelossofinformationandvariationfromcustomerspecificationiseliminated.

5.2.1 Thesiteshallhaveadocumentedartworkmanagementprocedurecoveringtheactivitiesforwhichthesitehasresponsibility.Thismayinclude,butisnotlimitedto:

• collationofinformationtobeincludedintoartwork

• receiptofartworkfilesfromthecustomer

• verificationofcompletedartworkandapprovalbythecustomer.

5.2.2 Aprocessshallbeinplacetoseekformalacceptanceandapprovaloffinalproductconceptsandartworksbythespecifier.

Theoutcomeshallbedocumented.

5.2.3 Whereappropriate,printtrialsshallbecarriedoutandtestingshallvalidatethattheagreedproductqualityandprintstandardscanbeconsistentlyachieved.

5.2.4 Printingequipmentsuchasplates,silkscreens,aniloxrollers,cylindersandblanketsshallbeverifiedasbeingcorrecttospecificationandartworkversionoragreedmasterpriortouse,andfullytraceabletothecustomer’sapprovedoriginationmaterial.

5.2.5 Customer-approvedreferencematerial,includingartworkmastersandcolour


standardsusedduringprintruns,shallbecontrolledtoensureminimisationofdegradationandshallbereturnedtoappropriatestorageafteruse.

Thesiteshallhaveapolicytoaddressrequirementsforrenewalofapprovedmasters,asnecessary.

5.2.6 Thesiteshallhaveadocumentedprocedureformanagingchangestoartworkandprintspecificationstomanageobsoleteartworkandprintingmaterials.

5.2.7 Whereartworkfilesandapprovedmastersareinelectronicform,theseshallbesuitablyprotectedtopreventlossormaliciousintervention.

Notes

5.3 Packagingprintcontrol

SOI Wherepackagingmaterialsareprintedordecorated,proceduresshallbeinplacetoensurethattheinformationisfullylegibleandcorrectlyreproducedtocustomerspecificationandanyapplicablelegalrequirements.

5.3.1 Anassessmentshallbecarriedoutofthepre-pressactivity,printprocessandhandlingofprintedpackaging(product)toidentify:

• risksoflossofessentialinformation

• mixingofprintedproduct.

Controlsshallbeestablishedandimplementedtoreducetherisksidentified.

5.3.2 Printingplates,cylinders,cuttingdies,printblanketsandanyotherprintingequipmentshallbeappropriatelystoredtominimisedamage.

5.3.3 Eachprintrunshallbeapprovedagainsttheagreedstandard(ormastersample).Thisshallberecorded.

5.3.4 Asystemshallbeinplacetodetectandidentifyprintingerrorsduringtherunandtosorttheseerrorsfromtheacceptableprintedmaterial.

5.3.5 Wherecompositeprintisused(amixtureofdifferentdesignsprintedtogether),aprocessshallbeinplacetoensureeffectivesegregationofdifferingprintvariants.

5.3.6 Samplesofprintedpackagingshallberetainedtogetherwithproductionrecordsforaperiodoftimetobeagreedwiththecustomer/specifier/brandowner.

5.3.7 Anyunusedprintedproductshallbeaccountedforandeitherdisposedoforidentifiedandappropriatelystored.

5.3.8 Lightinginprintinspectioncabinetsandothermeansofprint/colourcheckingshallbeagreedwiththecustomerorconformtoacceptedindustrystandards.


Notes

5.4 Processcontrol

SOI Documentedproceduresshallbeinplacetoensureeffectivequalityassuranceofoperationsthroughouttheprocess

5.4.1 Areviewofthemanufacturingand,whereapplicable,printingprocessshallidentifymanufacturingprocesscontrolpointsthatcouldsignificantlyaffectthequalityoftheproductsproduced.

5.4.2 Foreachmanufacturingprocesscontrolpoint,machinesettingsorprocesslimitsshallbeestablishedanddocumented–theprocessspecification.

5.4.3 Abillofmaterialsandprocessspecification(includingmanufacturingprocesscontrolpoints)shallbeavailableforeachbatchorlotduringproduction.

5.4.4 Documentedprocesschecksshallbeundertakenatstart-up,followingadjustmentstoequipmentandperiodicallyduringproduction,toensureproductsareconsistentlyproducedtotheagreedqualityspecification.

5.4.5 Adocumentedclearanceprocedureshallbeinplacetoensurethatatstart-upthelineisclearofallpreviousworkandproductiondocuments.

5.4.6 Intheeventofchangestoproductcomposition,processingmethodsorequipment,thesiteshall,whereappropriate,re-establishprocesscharacteristicsandvalidateproductdatatoensureproductsafety,legalityandqualityareachieved.

9.5.4.7 Thedocumentedlineclearanceprocedureshallinclude:

• therolesofpersonsinvolvedinlineclearance• areaswherematerialscanbecometrapped• validationofthelineclearance• sign-offforcontinuingproduction

Thelineclearanceprocedureshallbefullyimplementedforeachproductionrun.

Notes

5.5 Calibrationandcontrolofmeasuringandmonitoringdevices


SOI Thesiteshallbeabletodemonstratethatmeasuringandmonitoringequipmentissufficientlyaccurateandreliabletoprovideconfidenceinmeasurementresults.

5.5.1 Thesiteshallidentifyandcontrolin-lineandoff-linemeasuringequipmentusedtomonitorcriticalcontrolpoints(whereapplicable)andproductsafety,qualityandlegality.Thisshallincludeasaminimum:

• adocumentedlistofequipmentanditslocation

• anidentificationcodeandcalibrationduedate

• preventionfromadjustmentbyunauthorisedstaff

• protectionfromdamage,deteriorationandmisuse.

5.5.2 Allidentifiedmeasuringequipmentshallbecheckedandadjustedatapredeterminedfrequency,basedonriskanalysis.Thisshallbecarriedoutbytrainedstafftoadefinedmethodtoensureaccuracywithindefinedparameters.Allresultsshallbedocumented.

Wherepossible,calibrationshallbetraceabletoarecognisednationalorinternationalstandard.Whereatraceablecalibrationisnotpossible,thesiteshalldemonstratethebasisbywhichstandardisationiscarriedout.

5.5.3 Correctiveactionandreportingproceduresshallbeestablishedanddocumentedintheeventofthemonitoringandtestingprocedureidentifyinganyfailureofproductinspection,testingormeasuringequipment.Anysuchfailuresshallbesubjecttoanassessmentofpotentialrisk;subsequentactionmayincludeacombinationofisolation,quarantineandre-inspectionofproductsproducedsincethelastacceptancetestoftheequipment.

Thesiteshallconductarootcauseanalysisintotheequipmentfailureandimplementtheappropriatecorrectiveaction.

Notes

5.6 Productinspection,testingandmeasuring

SOI Thecompanyshalluseappropriatedocumentedproceduresandfacilitieswhenundertakingorsubcontractinginspectionandanalysescriticaltoproductsafety,legalityandquality.

5.6.1 Qualitychecksshallbecarriedouttodemonstratethatthefinishedproductiswithinthetoleranceslaiddownintheagreedproductspecificationandconformstoanycriticaltechnical/legalrequirements.

Thefrequencyofchecksshallbeinaccordancewithindustry-acceptedpracticeorcustomerrequirementsandbasedonriskanalysis.

5.6.2 Hazardandriskanalysisprinciplesshallbeusedtodeterminetheneedforin-lineproducttestingequipmenttoensureproductsafety,qualityandlegality.


5.6.3 Theaccuracyofin-lineequipmentshallbespecified(withpermittedtolerances),havingdueregardtotheproductparameterbeingcontrolled.

5.6.4 Thecompanyshallestablish,documentandimplementproceduresfortheoperation,routinemonitoringandtestingofallequipmentusedinproductinspection,testingandmeasurement.Thisshallinclude:

• frequencyandsensitivityofchecks

• authorisationoftrainedpersonneltocarryoutspecifiedtasks

• documentationoftestresults.

5.6.5 Routineoff-linequalitychecksshallbecarriedoutatappropriatestagesinproductiontodemonstratethattheproductiswithinthetoleranceslaiddownintheagreedproductspecification.

Asystem,whichincludesoff-lineorrandomisedqualitychecks,shallbeinplacetoidentifyandremovenon-conformingproductfromtheproductionlotandensurethatanyappropriateactionistakeninconsiderationoftherootcause.

5.6.6 In-linetestingequipmentcriticaltoproductqualityorsafetyshallincorporateasystemtoidentifynon-conformingproductforremovalordivertitoutoftheproductflow.

5.6.7 Proceduresshallbeinplacetoensurethereliabilityoftestresults.

5.6.8 Wherethecompanyundertakesorsubcontractsanalysescriticaltoproductsafetyorlegality,thelaboratoryorsubcontractorsshallhavegainedrecognisedlaboratoryaccreditationoroperateinaccordancewiththerequirementsandprinciplesofISO17025forthetestundertaken(Generalrequirementsforthecompetenceoftestingandcalibrationlaboratories).Documentedjustificationshallbeavailablewhereaccreditedmethodsarenotundertaken.

9.5.6.9 Samplesforcheckingin-processqualityshallbeselectedaccordingtocustomerrequirementsorbyindustrystandardtestingprotocols.

9.5.6.10 Thesiteshalldefinehowsamplesusedforcheckingin-processqualityaredisposedof.Thismaybebyreturningtostock,re-grind/recycling,orsegregationanddisposal.

9.5.6.11 Testmethods,analyticalmethodsandcustomerapprovedreferencesamplesshallbeavailable,keptuptodateinthelaboratoryorwhereoff-linetestingisconducted,andshallbesuitablystoredtoavoiddegradation.

9.5.6.12 Traceabilityoftestdataandsamplestoproductionlotsshallbemaintained.

9.5.6.13 Wheretestingshowsoutofspecificationresults,thereshallbeadocumentedprocedureonhowtheseresultsareinvestigatedtodetermineifthecauseoftheoutofspecificationresultsisnon-conformingproductoratestingfailure.

(Re-testingofanoutofspecificationsampleshallbedonetodemonstrateanalyticalerror,nottoreverseapreviousresult.)

9.5.6.14 Maintenancelogsshallbemaintainedforalloff-linetestingequipment.Thisshallincludeasaminimum:

• adjustments• re-calibration


• dateofanyinterventions.

Notes

5.7 Controlofnon-conformingproduct

SOI Thesiteshallensurethatout-of-specificationproductisclearlyidentifiedandquarantined.

5.7.1 Clearproceduresforthecontrolofout-of-specificationornon-conformingmaterialsshallbeinplace,documentedandunderstoodbyallpersonnel.Theseshallincludetheeffectiveidentificationandquarantiningofmaterialsbeforeadecisionhasbeenmadeontheirfinaldisposition.

5.7.2 Non-conformingmaterialsshallbeassessedandadecisiontakentoreject,acceptbyconcession,reworkorputtoalternativeuse.Thedecisionandreasonsshallbedocumented.

5.7.3 Correctiveactions,rootcauseanalysisandpreventiveactionsshallbeimplementedtoavoidrecurrenceofthenon-conformity.Actionstakenshallbedocumented.

Notes

5.8 Incominggoods

SOI Incominggoodsshallbeappropriatelycheckedforcontents,packagingintegrityandpotentialcontamination.

5.8.1 Thesiteshalldocumentarawmaterialsandintermediateproductintakeproceduretoensurethatincominggoodsmatchpurchaseorproductspecifications.Thismaytaketheformof:

• purchaseorders

• deliverynotes.

5.8.2 Receiptdocumentsand/orproductidentificationshallfacilitatecorrectstockrotationofgoodsinstorageand,whereappropriate,ensurematerialsareusedinthecorrectorderandwithintheprescribedshelflife.

9.5.8.3 Allincomingrawmaterialsshallbeappropriatelyvalidatedortestedpriortouse.

Allrawmaterialsawaitingresultsofin-housetestingorvalidationofdatashallbe


helduntilreleasedforuse.

Notes

5.9 Storageofallmaterialsandintermediateandfinishedproducts

SOI Thestorageofallmaterialsandproductsshallminimisetheriskofcontaminationormaliciousintervention,andprotectproductsafety,qualityandlegality.

5.9.1 Allmaterials,workinprogressandproductshallbeproperlyidentifiedandprotectedduringstoragebyappropriatepackagingtoprotecttheproductfromcontamination.

5.9.2 Storage,includingoff-sitestorage,shallbecontrolledtoprotecttheproductfromcontamination,includingtaintorodourandmaliciousintervention.Whereoff-sitestorageisused,thesamesitestandardsrequirementsapplyasforon-sitestorage.

5.9.3 Inordertopreventcontamination,documentedproceduresshallbeinplacetoappropriatelysegregaterawmaterials,intermediateproductsandfinishedproducts.

5.9.4 Thesiteshallensurethathazardouschemicalsarehandledinsuchawaythatrisktoproductsafety,qualityandlegalityisminimised.

5.9.5 Materialintendedforrecyclingshallbeappropriatelyprotectedagainstcontaminationhazards.

9.5.9.6 Allrawmaterialsshallhaveanexpirationdatedefinedanddocumentedandaproceduredefininghowtheyshouldbehandledwheretheyexceedthisdate.

Whererawmaterialshavenoreasonableexpirationdate,e.g.culletforglassmanufacture,thisshallbedocumented.

9.5.9.7 Warehousingequipmentshallbekeptinagoodstateofrepairandcleanliness.

9.5.9.8 Materialsshallbestoredawayfromwallstoaidcleaningandinspectionofproductionandstorageareas.

9.5.9.9 Tominimisetheriskofmix-upsandcrosscontamination,differentmaterialsshallnotbestoredonthesamepalletunlessphysicallysegregated.

Notes


5.10 Dispatchandtransport

SOI Thedispatchandtransportofrawmaterialsandfinishedproductsshallbeundertakeninamannerthatminimisestheriskofcontaminationormaliciousinterventionandmaintainsproductsafety,legalityandquality.

5.10.1 Allproductsandmaterialsshallbeidentifiedandeitherprotectedduringdistributionbyappropriateexternalpackagingortransportedunderconditionstoprotecttheproductfromcontamination.Thisshallincludetheriskoftaintorodourandofmaliciousintervention.

5.10.2 Allpalletsshallbechecked.Damaged,contaminatedorunacceptablepalletsshallbediscarded.Woodenpalletsthatcomeintodirectcontactwithfinishedproductsorrawmaterialsshallnotbeallowedtocontaminatetheproduct.Woodenpallets,ifused,shallbesound,dry,cleanandfreefromdamageandcontamination.

5.10.3 Allcompany-ownedvehiclesusedfordeliveriesshallbeincludedinthedocumentedcleaningschedulesandkeptcleanandinaconditiontominimisetheriskofproductcontamination.

5.10.4 Alldeliveryvehiclesandshippingcontainersshallbesubjecttoadocumentedhygiene-checkingprocedurebeforeloading.

5.10.5 Wherethecompanyemploysthird-partycontractorsthereshallbeacontractoragreedtermsandconditions.AlltherequirementsspecifiedinthissectionshallbeclearlydefinedinthecontractorthecompanyshallbecertificatedtotheGlobalStandardforStorageandDistribution.

Wherethisisnotpossible,withgeneralcarriers,thepackagingshallbeadequatetoprotecttheproductagainstdamage,contaminationhazards,taintandodour.

5.10.6 VehicledriversshallcomplywiththesiterulesrelevanttothisStandard.

Accesstothesiteforthird-partytransportpersonnelshallbecontrolledand,wherepossible,facilitiesprovidedtonegatetheneedtoenterstorageorproductionareas.

Notes

5.11 Producthandling

SOI Thehandlingandmanagementofintermediateandfinishedproductsshallensuretheirqualityismaintained.

9.5.11.1 Packagingusedforstorageordespatchofintermediateorfinishedproducts,suchaspallets,shallbeappropriatelycoveredifstoredoutsideandinspectedforsignsofdamageorcontaminationpriortouse.

9.5.11.2 Finishedproductsshallnotbestoredoutside.


9.5.11.3 Thesiteshallhaveasysteminplacetovalidateallrawmaterialsandintermediateproductspriortointroductiontotheprocess.

9.5.11.4 Unloadingareasforbulkdeliveriesshallbeclearlyidentifiedanddesignedtopreventproductmix-ups.

9.5.11.5 Finishedproductstorageshallmeetcustomerrequirements(withregardstofirst-in-first-out,orFIFO,whereapplicable),withdispatchafterqualityrelease.

Notes

5.12 Productrelease

SOI Thefinalproductreleasetothecustomershallbedeterminedbyasuitablytrainedandcompetentperson.

9.5.12.1 Thesiteshallhaveaprocedurethatdefineshowthereleaseofproductsshallbeapprovedbyanauthorisedperson.

Thisprocedureshallensurethatonlyproductmeetingspecificationisshipped.

Notes

5.13 Validationandchangecontrol

SOI Thelabellingofintermediateandfinishedproductshallfacilitateidentificationthroughoutthesupplychain.

9.5.13.1 Allcodingappliedtointermediateorfinishedproductsshallbecheckedforlegibilityandaccuracyagainstproductionrecords.

9.5.13.2 Labellingoranyothertypeofidentificationshallbeappliedatthelineofmanufactureuponcompletion.

9.5.13.3 Thesiteshallhavedocumentedprocedureinplacecontrollinglabelreprintsandpalletlabelling.


Notes

6 Personnel

6.1 Trainingandcompetence

rawmaterialshandling,preparation,processing,packingandstorageareas

SOI Thecompanyshallensurethatallpersonnelareadequatelytrained,instructedandsupervisedcommensuratewiththeiractivityandthattheyarecompetenttoundertaketheirjobrole.

6.1.1 Allpersonnel,includingtemporarypersonnelandcontractors,shallbeappropriatelytrainedpriortocommencingworkandadequatelysupervisedthroughouttheworkingperiod.Inductiontrainingshallincludethecompanyhygienerules.

6.1.2 Wherepersonnelareengagedinactivitiesrelatingtoproductsafety,qualityandlegality,relevanttrainingandcompetencyassessmentshallbeinplace.Thismayinclude,butisnotlimitedto:

• productinspection,testingandmeasuring

• calibration

• printedpackagingcontrols

• operativesatmanufacturingprocesscontrolpoints.

6.1.3 Thecompanyshallroutinelyreviewanddocumentthecompetenciesofallstaffandproviderelevanttrainingasappropriate.Thismaybeintheformoftraining,refreshertraining,coaching,mentoring,oron-the-jobexperience.

6.1.4 Recordsoftrainingshallbeavailable.Theseshallinclude:

• thenameofthetraineeandconfirmationofattendance

• thedateanddurationofthetraining

• thetitleorcoursecontents,asappropriate

• thetrainingprovider(externalorinternalprovider).

Wheretrainingisundertakenbyagenciesonbehalfofthecompany,recordsofthetrainingshallbeavailable.

6.1.5 Thesiteshallputinplacedocumentedprogrammescoveringthetrainingneedsofrelevantpersonnel.Theseshallincludeasaminimum:

• identifyingthenecessarycompetenciesforspecificroles

• providingtrainingorotheractiontoensurestaffhavethenecessarycompetencies

• reviewingtheeffectivenessoftraining


• thedeliveryoftrainingintheappropriatelanguageoftrainees.

9.6.1.6 Theeffectivenessoftrainersshallbemonitoredandverified.

9.6.1.7 Thesiteshallensurethatthecompetencyofpersonnelresponsibleforlaboratorytestingandassessmentismaintainedanddeveloped.

Notes

6.2 Personalhygiene

rawmaterialshandling,preparation,processing,packingandstorageareas

SOI Thesite’spersonalhygienestandardsshallbedevelopedtominimisetheriskofproductcontaminationfrompersonnel.Thesestandardsshallbeappropriatetotheproductsproducedandbeadoptedbyallpersonnel,includingagency-suppliedstaff,contractorsandvisitorstotheproductionfacility.

6.2.1 Therequirementsforpersonalhygieneshallbedocumentedandcommunicatedtoallpersonnel.Theseshallinclude,asaminimum,thefollowinginstructions:

• watchesshallnotbeworn

• jewelleryshallnotbewornonexposedpartsofthebody,withtheexceptionofaplainweddingringorweddingwristbandandsleeperearrings(continuousloop).

• perfumeoraftershaveshallnotbeworn.

Compliancewiththerequirementsshallbecheckedroutinely.

6.2.2 Handwashingshallbeperformedonentrytotheproductionareasandatafrequencythatisappropriatetominimisetheriskofproductcontamination.

6.2.3 Personalitemsandbelongings,includingpersonalmobilephones,shallnotbetakenintoproductionareaswithoutthepermissionofthemanagement.

6.2.4 Proceduresandwritteninstructionsshallbeinplacetocontroltheuseandstorageofpersonalmedicines,tominimisetheriskofproductcontamination.

6.2.5 Fingernailsshallbekeptshortandclean.Falsefingernails,nailvarnish/polishornailartshallnotbepermitted.Wherevisitorscannotcomply,suitablecontrolproceduresshallbeinplace(e.g.non-handlingofproduct,useofgloves).

6.2.6 Allcutsandgrazesonexposedskinshallbecoveredbyanappropriatelycolouredplasterthatisdifferentfromtheproductcolour(preferablyblue).Theseshallbesiteissuedandmonitoredwheninvolvedinworkwithmaterialsintendedtocomeintodirectcontactwithfoodorotherhygiene-sensitiveproducts.Whereappropriate,inadditiontotheplaster,afingerstallorgloveshallbeworn.


Notes

6.3 Stafffacilities

SOI Stafffacilitiesshallbesufficienttoaccommodatetherequirednumberofpersonnelandshallbedesignedandoperatedtominimisetheriskofproductcontamination.Suchfacilitiesshallbekeptinagoodandcleancondition.

6.3.1 Lockerroomsshallbeaccessedwithouttheneedtoenterproductionareasunlessappropriatelysegregatedwalkwaysareinplace.

6.3.2 Lockersshallbeprovidedforallpersonnelwhoworkinrawmaterialhandling,processing,preparation,packingandstorageareas.Lockersshallbeofsufficientsizetoaccommodateallreasonablepersonalitemsandanyprotectiveclothingrequired.

6.3.3 Site-issuedprotectiveclothingandpersonalclothingshallnotbestoredinthesamelockerorshallbeeffectivelysegregatedwithinthelocker.

6.3.4 Eating(includingtheeatingofconfectioneryandchewingofgumortobacco),drinkingandsmokingshallnotbeallowedinlockerandchangingrooms.

6.3.5 Suitableandsufficienthand-washingfacilitiesshallbeavailabletoenablecleaningofhandsbeforecommencingwork,afterbreaks,andasnecessaryduringthecourseofwork.Suchhand-washingfacilitiesshallprovide,asaminimum:

• sufficientquantityofwateratasuitabletemperaturetoencouragehandwashing

• unscentedliquidsoaporfoam

• adequatehand-dryingfacilities

• advisorysignstopromptuse(includingsignsinappropriatelanguages).

Wherematerialsarehandledthatwillbeindirectcontactwithfoodorotherhygiene-sensitiveproducts,hand-washingfacilitiesshallbesitedattheentrancetotheproductionarea.

6.3.6 Toiletsshallnotopendirectlyintostorage,processingorproductionareasinordertopreventtheriskofcontaminationtoproduct.Toiletsshallbeprovidedwithsuitableandsufficienthand-washingfacilities.

6.3.7 Facilitiesforvisitorsandcontractorsshallenablecompliancewiththesite’shygienepolicy.

6.3.8 Allfoodbroughtintomanufacturingpremisesshallbestoredinacleanandhygienicstate.Nofoodshallbetakenintostorage,processingorproductionareas.

6.3.9 Eating(includingtheeatingofconfectioneryandchewingofgumortobacco),drinkingandsmokingshallnotbeallowedintheproductionorstorageareas.Ifitisimpracticalforpersonneltoleavetheirworkarea,localcontrolledfacilities(suchasa


fullywalledareawithhand-washingfacilities)shallbeprovided.

6.3.10 Drinkingofwaterfrompurpose-madedispensersand/orbyusingdisposableconicalcupsorspill-proofliddedcontainersmaybeallowed,provideditisconfinedtoadesignatedareaawayfromequipment.

6.3.11 Wheresmokingisallowedundernationallaw,itshallonlybepermittedindesignatedcontrolledsmokingareaswhichshallbeisolatedfromproductionandstorageareasandfittedwithextractiontotheexteriorofthebuilding.Adequatearrangementsfordealingwithsmokers’wasteshallalsobeprovidedatsmokingfacilities,bothinsidebuildingsandatexternallocations.

Theuseofelectroniccigarettesandassociatedmaterialsshallnotbepermittedinlockerrooms,orinproductionorstorageareas,andshallonlybepermittedindesignatedsmokingareas.

Notes

6.4 Medicalscreening

SOI Thecompanyshallensurethatdocumentedproceduresareinplacetoensurehealthconditionslikelytoadverselyaffectproductsafetyaremonitoredandcontrolled.

6.4.1 Wherethereishandlingofmaterialsintendedfordirectcontactwithfoodorotherhygiene-sensitiveproducts,thesiteshallmakeemployeesawareofthesymptomsofinfection,diseaseorconditionwhichwouldpreventapersonworking.Thesiteshallhaveaprocedureforthenotificationbypersonnel,includingtemporarypersonnel,ofanyrelevantinfections,diseasesorconditionswithwhichtheymayhavebeenincontactorbesufferingfrom.

Employees,contractorsandvisitorssufferingfromanyoftheaboveshallbeexcludedfromworkinvolvingthehandlingofdirect-foodcontactorotherhygiene-sensitiveproductpackagingforaslongasthesymptomspersist.

6.4.2 Wherepermittedbylaw,visitorsandcontractorsshallberequiredtofillinahealthquestionnaireorotherwiseconfirmthattheyarenotsufferingfromanysymptomswhichmayputproductsafetyatrisk,priortobeingallowedintoproduction,packingorstorageareas.

Notes

6.5 Protectiveclothing


SOI Appropriateprotectiveclothingshallbeworninproductionandstorageareastominimisetheriskofproductcontamination.

6.5.1 Hazardandriskprinciplesshallbeusedtodeterminetheneedforprotectiveclothing,includinggarmentsandfootwearinrawmaterialshandling,preparation,productionandstorageareas.

Wherenoneedforprotectiveclothinghasbeenestablishedbyriskassessmentinaparticulararea,itshallbefullyjustifiedandshallnotposeacontaminationrisktotheproduct.

6.5.2 Thecompanyshalluseriskassessmenttodetermine,documentandcommunicatetoallemployees,includingtemporarypersonnelandcontractors,therulesregarding:

• thewearingofprotectiveclothingonthejourneytowork

• thewearingofprotectiveclothinginrawmaterialshandling,preparation,productionandstorageareas

• thewearingofprotectiveclothingawayfromtheproductionenvironment(e.g.removalbeforeenteringtoilets,canteenorsmokingareas).

6.5.3 Wheretheneedforprotectiveclothinghasbeendetermined,appropriatecleanprotectiveclothingthatcannotcontaminatetheproductshallbeworn.Sufficientsetsofclothingappropriatetotheactivitiescarriedoutshallbeprovided.

6.5.4 Protectiveclothingworninproductionareasshallprovideadequatecoverageoftheuppertorso.

Wherethereishandlingofmaterialsintendedfordirectcontactwithfoodorotherhygiene-sensitiveproducts,theclothingshallhavenoexternalpocketsontheupperbodygarmentsorsewn-onbuttons.Changesofsuchclothingshallbeavailableatalltimesasrequired.

6.5.5 Basedontheassessmentofrisktotheproduct,suitablefootwearshallbewornwithinthefactoryenvironment.

6.5.6 Inproductionandpackingareas,hazardandriskanalysisshallbeusedtodeterminetheneedfor:

• snoodsforbeardsandmoustaches

• scalphaircoverings.

6.5.7 Ifglovesareusedtheyshallbereplacedregularly,bedistinctive,intactandnotcauseacontaminationrisktotheproduct.

6.5.8 Protectiveclothingshallbekeptcleanandlaundered.Launderingshallbecarriedoutbyoneofthefollowingmethods:

• professionallaundryservice

• in-house

• controlledlaunderingfacilities

• self-care.

6.5.9 Whereself-carelaundryispermitted,itshallbeensuredthat:

• employeeshavereceivedwritteninstructionsregardingthelaundering


processtobeusedandtheseshallbereinforcedaspartofaninductionorotherin-housetrainingprogramme

• employeesshallbeprovidedwithsuitablemeanstosafelytransportwashedgarmentsfromhometotheworkplace

• thereshallbeadefinedprocesswithinthesiteformonitoringtheeffectivenessofthesystem

• thereshallbeaprocedureandsystemfordealingwithanycasewhereemployeesareunabletoperformself-laundryeffectively,throughlackofeitherdiligenceorfacilities.

6.5.10 Cleananddirtyclothingshallbesegregatedandcontrolledtopreventcross-contamination.

6.5.11 Disposableprotectiveclothing,ifused,shallbesubjecttoadequatecontroltoavoidproductcontamination.

Notes