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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
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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.
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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.
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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
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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
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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
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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
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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.
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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.
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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
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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.
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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
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• 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.
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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.
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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.
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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.
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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
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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:
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• 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.
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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.
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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.
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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
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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.
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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
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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.
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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):
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• 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
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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.
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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
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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.
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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
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• 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
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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
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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.
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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.
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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
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• 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.
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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
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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
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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
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processtobeusedandtheseshallbereinforcedaspartofaninductionorotherin-housetrainingprogramme
• employeesshallbeprovidedwithsuitablemeanstosafelytransportwashedgarmentsfromhometotheworkplace
• thereshallbeadefinedprocesswithinthesiteformonitoringtheeffectivenessofthesystem
• thereshallbeaprocedureandsystemfordealingwithanycasewhereemployeesareunabletoperformself-laundryeffectively,throughlackofeitherdiligenceorfacilities.
6.5.10 Cleananddirtyclothingshallbesegregatedandcontrolledtopreventcross-contamination.
6.5.11 Disposableprotectiveclothing,ifused,shallbesubjecttoadequatecontroltoavoidproductcontamination.
Notes