膳食补充剂生产检查表 dietary-supplements-manufacturing-checklist-edition-10

,DietarySupplementsManufacturingEdition10Checklist,,,

Clause,Item,PrimaryResponse,Evidence,SupplierOnsiteCorrection/CorrectiveAction

OpeningMeeting,PeoplePresentattheOpeningMeeting(PleaselistnamesandrolesinthefollowingformatName:Roleseparatedbycomas),,,

ClosingMeeting,PeoplePresentattheClosingMeeting(PleaselistnamesandrolesinthefollowingformatName:Roleseparatedbycomas),,,

FacilityDescription,"AuditorDescriptionofFacility(Pleaseprovidefacilitydescriptioninclude#ofemployees,size,productionschedule,generallayout,andanyadditionalpertinentdetails",,,

AuditorRecommendation,AuditorRecommendation,,,

,SQFSystemElementsforFoodManufacturing,,,

2.1,ManagementCommitment,,,

2.1.1,ManagementResponsibility(Mandatory)(CoreClause),,,

,"Afoodsafetypolicy,signedbytheseniorsitemanagershallbeestablishedandmaintainedthatoutlinesataminimumthecommitmentofallsitemanagementto:

i.Supplysafeproductsincompliancewithallcustomerandregulatoryrequirements;

ii.Establishandmaintainapositivefoodsafetyculturewithinthesite;

iii.Establishandcontinuallyimprovethesite'sfoodsafetymanagementsystem;and

iv.

Effectivelycommunicatethispolicytoallpersonnelinalanguage(s)theyunderstand.",,,

,"SitemanagementshallbuildapositivefoodsafetyculturewithinthesitethatensuresthatallrequirementsoftheSQFFoodSafetySystemareimplementedandmaintained.

Allpersonnelshall:

i.Understandandfulfilltheirfoodsafetyandregulatoryresponsibilities;

ii.Notifymanagementaboutactualorpotentialfoodsafetyissues;

iii.Acttoresolvefoodsafetyissueswithintheirscopeofwork;and

iv.Demonstratecommitmenttotheproductionandsafehandlingoffood.",,,

,"Afoodsafetycultureassessmentplantodrivecontinuousimprovementshallbedocumented,implemented,andmaintained.

Thisplanshalladdressataminimum:

i.Effectivecommunicationstrategiestoensureallpersonnelareinformedandengagedinfoodsafetypractices;

ii.Comprehensivetrainingprogramsforallpersonnelincludingsitemanagement;

iii.Mechanismtocollectandaddressfeedbackfromallpersonnelregardingfoodsafetypractices;and

iv.Regularmeasurementandevaluationoffoodsafety-relatedactivities.",,,

,"Sitemanagementshallestablish,document,andcommunicatetoallpersonnelfoodsafetyobjectivesandperformancemeasures.Theywillensuredepartmentsandoperationsareappropriatelystaffedandorganizationallyalignedwithadequateresourcestomeetthesefoodsafetyobjectives.

Thereportingstructurewill:

i.Documentthejobfunctionsforkeypersonnelwhoseactivitiesaffectfoodsafety,regulationandqualitycontrol,andtheperformancemeasuresandassociatedregulatorylicensing;

ii.Identifyabackup(s)forthesekeypersonnel;and

iii.Ensuretheintegrityandcontinuedoperationofthefoodsafetysystemintheeventoforganizationalorpersonnelchanges.",,,

,"AprimaryandsubstituteSQFPractitionershallbedesignatedwithresponsibilityandauthorityto:

i.Overseethedevelopment,implementation,review,andmaintenanceoftheSQFSystemthroughanunderstandingoftheSQFFoodSafetyCode(s)relevanttothesite'sscopeofcertification;

ii.TakeappropriateactiontoensuretheintegrityoftheSQFSystemandescalatetositemanagementkeyfoodsafetyissuesorevents;

iii.CommunicatetorelevantpersonnelallinformationessentialtoensuretheeffectiveimplementationandmaintenanceoftheSQFSystem,includingparticipationintheannualmanagementreviewandmonthlymanagementupdates;

iv.EnsuretheproperuseoftheSQFlogo,accordingtotherequirementsintheSQFLogoRulesofUse;and

v.EnsurerelevantblackoutdatesareprovidedtotheCertificationBodyaminimumofninety(90)dayspriortothestartoftheauditwindowthatpreventanauditfromoccurringoutofseasonorwhenthesiteisnotoperatingforlegitimatebusinessreasons.

TheprimaryandsubstituteSQFPractitionersshall:

i.Beemployedatthesite(whiledesignatedastheprimarySQFPractitioner);

ii.HavesuccessfullycompletedaHazardAnalysisandCriticalControlPoint(HACCP)-basedtrainingcourse;and

iii.Becompetenttoimplementandmaintainthesite'sfoodsafetyplans.",,,

2.1.2,ManagementReview(Mandatory)(CoreClause),,,

,"TheSQFSystemshallbereviewedbysitemanagementatleastannuallyandinclude:

i.Changestofoodsafetymanagementsystemdocumentation(e.g.,policies,procedures,specifications,foodsafetyplan,foodsafetypolicy);

ii.Resultsofannualsystemtests(e.g.,fooddefense,crisismanagement,recall,andproducttrace);

iii.Trendsrelatedtothefoodsafetymanagementsystem(e.g.,auditandinspectionfindings,complaints,pestpreventionprogram);

iv.Performancetowardsfoodsafetycultureassessmentplan;

v.Performancetofoodsafetyobjectivesandmeasures;

vi.Reviewofrecallsandregulatoryissues;

vii.Updatestoallhazardanalysesandriskassessments;and

viii.Follow-upactionitemsfrompreviousmanagementreviews.",,,

,"Sitemanagementshallbeupdatedatleastmonthlyandinclude:

i.MattersimpactingtheimplementationormaintenanceoftheSQFSystem(e.g.,deviationsofCCPs,labelchanges,regulatoryissues,adversetrends);

ii.Corrections,andcorrectiveandpreventativeactions;

iii.Resultsfrominternalandexternalaudits;and

iv.Foodsafetycomplaints.",,,

2.1.3,ComplaintManagement(Mandatory)(CoreClause),,,

,"Themethodsandresponsibilityforhandling,investigating,andresolvingfoodsafetycomplaintsfromcustomers,consumers,andauthorities,arisingfromproductsmanufacturedorhandledon-siteorco-manufactured,shallbedocumentedandimplemented.

Itshallminimallyinclude:

i.Thequalifiedpersonresponsibleforreviews,approvals,andfollow-upactivities;and

ii.Requiredactionswhencomplaintsdeterminethatproductsarepotentiallynotmeetingfinishedproductspecifications.",,,

,Trendsofcomplaintdatashallbeinvestigatedandanalyzed.Rootcauseanalysisandthecorrectiveactionprocessshallbecompletedforalladversetrendsandseriousincidentsasoutlinedin2.5.3.,,,

2.2,DocumentationandRecords,,,

2.2.1,FoodSafetyManagementSystem(Mandatory),,,

,"ThesiteshallensurethatalldocumentationusedtomeettherequirementsoftheSQFFoodSafetyCoderelevanttothescopeofcertificationareestablished,implemented,maintained,keptcurrent,andmadeavailabletotherelevantpersonnel.Documentationshallincludeproductionandandprocesscontrolproceduresandspecificationssupportingorimpactingregulatorylimits/claimsandfoodsafety.Documentationmaybeinelectronicand/orhardcopyform.",,,

2.2.2,DocumentControl(Mandatory),,,

,Themethodsandresponsibilityformaintainingdocumentcontrolandensuringpersonnelhaveaccesstocurrentrequirementsandinstructionsshallbedocumentedandimplemented.Currentfoodsafetydocumentsshallbemaintainedandchangescommunicatedtorelevantpersonnelwhendocumentshavebeenrevised.,,,

2.2.3,Records(Mandatory),,,

,"Thesiteshallmaintainrelevantandappropriaterecords,asnecessary,todemonstratetheeffectiveimplementation,maintenance,andcontinuousimprovementofthefoodsafetymanagementsystem.Themethodsandresponsibilityformaintainingandretainingrecordsshallbedocumentedandimplemented.",,,

,"Recordsshallbelegible,readilyaccessible,retrievable,andsecurelystoredtopreventunauthorizedaccess,loss,damage,anddeterioration.Retentionperiodsshallbeinaccordancewithcustomer,legal,andregulatoryrequirements,atminimumtheproductshelflife,oriflonger,thedeliverymedium(e.g.,capsules,coatings,sachets)shelflife,orestablishedbythesiteifnoshelflifeexists.",,,

,"Recordstosupportthecompletionofallannualrequirements,includingrelevantdocuments(e.g.,rootcausemethodology,corrections,andcorrectiveandpreventativeactions)shallbemaintainedandincludeataminimum:

i.Managementreview(referto2.1.2);

ii.Internalaudits(referto2.5.4);

iii.Fooddefensethreatassessmentandpreventionplanreview(referto2.7.1);

iv.Fooddefensetest(referto2.7.1);

v.Foodfraudvulnerabilityassessmentandmitigationplanreview(referto2.7.2);

vi.Traceabilitytest(referto2.6.2);

vii.Crisismanagementtest(referto2.6.4);

viii.Recalltest(referto2.6.3);and

ix.Foodsafetyplanreview,includingprocessflow(referto2.4.3).",,,

,"Whereapplicable,recordsdemonstratingtheimplementationofthefoodsafetymanagementsystemshallbemaintainedandinclude:

i.Monthlymanagementupdates(referto2.1.2);

ii.Productdevelopmentapprovals(referto2.3.1);

iii.Supplierapprovals(referto2.3.4);

iv.Rootcauseanalysisandthecorrectiveactionprocess(referto2.5.3);

v.Validationandverificationrecords(referto2.5.1and2.5.2);

vi.Processchanges(referto2.3.5);

vii.Complaints,investigations,andresolutions(referto2.1.3);and

viii.Contractualagreements(referto2.3.3).",,,

,"Whereapplicable,recordstosupportthefoodsafetyprogramsshallbemaintainedandinclude:

i.Productrework(refer2.4.6);

ii.Inspectionandanalysis(referto2.4.4);

iii.Productrelease(referto2.4.7);

iv.GoodIndustryPractices(GIP)inspections(referto);

v.Productchangeover(referto2.6.1);

vi.Labelreconciliation(referto2.6.1);

vii.Criticalcontrolpointmonitoring(referto6);

viii.Non-conformingmaterialsandproducts(referto2.4.5);

ix.Environmentalmonitoring(referto2.4.8);and

x.Producttraceabilityandrecall(referto2.6.2and2.6.3).",,,

2.3,"Specifications,ProductDevelopment,andSupplierApproval",,,

2.3.1,ProductDevelopment,,,

,"Themethodsandresponsibilityfordesigning,developingandimplementingnewproductsintoproductionthroughcommercializationshallbedocumentedandimplemented.

Reintroducingproductsnotinproductionformorethanayearshallbeassessedtoensurecontrolsarestilleffectiveforchangesthathaveoccurredtoprocessesorprocedures.",,,

,"Productformulationsshallbedevelopedbyauthorizedpersonneltoensurethattheymeettheintendeduse.Wherenecessary,trialsshallbeconductedtoensureproductsmeetfoodsafetyrequirements.Considerationshallbegiven,whereapplicable,to:

i.Pre-consumerandconsumerpreparation,storageandhandlingrequirements,includingtheestablishmentof“useby,”“bestbeforedates,”orequivalentterminology;

ii.Microbiologicalcriteria;

iii.Foodcontactpackagingadequacy;

iv.Customerrequirements;

v.Labelingrequirements;and

vi.Ensuringingredientsareconsidered""food""orrecognizedassafebyregulatorybodiesinthecountryofmanufactureandthecountryofuseorintendedsale.",,,

,"Newproductformulations,manufacturingprocesses,andthefulfillmentofproductrequirementsshallbeestablished,validated,andverifiedbysitetrialsandproducttestingasrequiredtoensure:

i.Productsafety,regulatorylimits(e.g.,potency,strength,homogeneity,andpurity),andclaimsaremaintainedtotheendoftheshelflife;

ii.Manufacturingprocessesandinstructionsensureproducthomogeneity,flushingsequences,specialinstructions,andcleanoutprocedures;

iii.Productformulationsaredevelopedbyauthorizedpersons;

iv.Shelflifestudiesaccountforpre-consumerhandlingandstoragerequirementsincludingtheestablishmentof“useby,”“bestbeforedates,”orequivalentterminology;and

v.Instructionsforconsumerpreparation,whereapplicable,andstorageandhandlingrequirements.",,,

2.3.2,Specifications,,,

,"Themethodsandresponsibilityfordeveloping,managing,andapprovingrawmaterial,finishedproduct,andpackagingspecificationsshallbedocumented.",,,

,"Specificationsforallrawmaterialsandpackaging,including,butnotlimitedto,ingredients,additives,hazardouschemicals,processingaids,andpackagingthatimpactfinishedproductsafetyshallbedocumentedandkeptcurrent.

Thespecifications,whereapplicable,shallensurethatwhenrawmaterialsareusedaccordingtoformulationorrecipethatthepurity,strength,andcompositionofthefinishedproductmeetlabeldeclarationsandregulatoryrequirements.",,,

,"Rawmaterial,packaging,andingredientspecificationsshallbereviewedandconfirmedtoensureproductsafetyisnotcompromisedandthematerialarefitfortheirintendedpurpose.",,,

,"Sitemanagementshallrequirerawmaterialssupplierstonotifythesiteofchangesinproductcompositionthatcouldhaveanimpactonproductformulation(e.g.,proteincontent,moisture,aminoacidprofiles,contaminantlevels,allergens,and/orotherparametersthatmayvarybycroporbyseason).",,,

,"Finishedproductlabelsshallbeaccurate,complywiththerelevantlegislation,andbeapprovedbyqualifiedpersonnel.",,,

,"Finishedproductspecificationsshallbedocumented,current,accessibletorelevantpersonnel,andshallinclude,whereapplicable:

i.Microbiological,chemical,andphysicallimits;

ii.Purity,strength,andcompositionsupportingregulatoryandqualitylabelclaims;

iii.Limitsorlevelsofpossibleadulterants;

iv.Labelingandpackagingrequirements;

v.Storage,distribution,andhandlingconditions;and

vi.Theshelflifeoftheproduct.

Allfinishedproductspecificationsshallbeapprovedbythesite,and,whenrequired,byitscustomer.",,,

2.3.3,ContractualAgreements,,,

,"Allagreementswithcontractmanufacturers,third-partystorageanddistributionfacilities,andcontractserviceprovidersthathaveanimpactonproductsafetyshallbedocumentedandinclude:

i.Informationtoensureallfoodsafetyrequirementsaremet;and

ii.Afulldescriptionoftheproductandservicestobeprovided.

Theseagreementsshallbeapprovedbybothparties,communicatedtorelevantpersonnel,andkeptcurrent.",,,

,"Forproductsandprocessesofco-manufacturersandthird-partystorageanddistributionfacilities,thesiteshallensurethattheyareconfirmedtobeincompliancewiththerelevantSQFFoodSafetyCode.Confirmationisdeterminedrelevanttotherisklevel,throughanauditbythesite,athird-partyagency,orothersuitablemeans.Thesiteshalldetermineanddocumentthefoodsafetyrisklevelofcontractmanufacturedand/orcontractstoredproduct.",,,

2.3.4,ApprovedSupplierProgram(Mandatory)(CoreClause),,,

,"Themethodsandresponsibilityforselecting,evaluating,approving,andmonitoringsuppliers,includingemergencysuppliersandsuppliersunderthesamecorporateownership,shallbedocumented,implemented,andinclude,ataminimum:

i.Pastperformanceofasupplier;

ii.Risklevelofthesuppliedproduct(e.g.,allergencontaining,ready-to-eat,foreignsupplier);

iii.Agreedspecifications;

iv.Summaryofthefoodsafetycontrolsimplementedbythesupplier;

v.Methodsforgrantingapprovalandreviewingsupplierstatus;

vi.Methodsandfrequencyofmonitoringsupplierperformance;

vii.Methodsandfrequencyofverificationofsuppliedproductincludingpackaging;and

viii.Suppliercontactdetails.",,,

,Supplierauditsshallbebasedonriskandshallbeconductedbypersonnelknowledgeableofapplicableregulatoryandfoodsafetyrequirements.,,,

2.3.5,ChangeManagement,,,

,"Thesiteshalldocumentandimplementaproceduretoevaluateanychanges,includingtemporary,emergency,unplanned,orthosemadeasaresultofthecorrectiveactionprocess,thatcouldimpactfoodsafetyorthefoodsafetysystemtoensurethatcontrolsarestilleffective.

Thisprocedure,ataminimum,shallincludechangesin:

i.Productformulationsandmanufacturingprocessesforproductsincludedinthescopeofcertification;

ii.Materials,ingredients,labels,otherinputs,orequipment;

iii.Specificationsforrawmaterialsandpackaging,chemicals,processingaids,contractservices,andfinishedproducts;and

iv.Thefoodsafetyplanincludingcriticalcontrollimits.

Changesshallbeconfirmedorvalidated,documentedandcommunicated,asnecessary,inatimeframethatensuresfoodsafetyismaintained.",,,

2.4,FoodSafetySystem,,,

2.4.1,FoodLegislation(Mandatory),,,

,"Thesiteshallensurethatatthetimeofdeliverytocustomersfinishedproductsshallcomplywith:

i.Foodsafetylawsandregulationsapplicableinthelocality,countryofmanufacture,andintendedsale,ifknown;and

ii.Customerandcompanyrequirements.

iii.Compliancewithregulatorylicensingrequirementsforthesiteand/oritssuppliersandcustomers;

Thisincludescompliancewithlegislativerequirementsapplicabletomaintainingsanitaryconditionsduringprocessing,maximumresiduelimits,foodsafety,packaging,productdescription,netweights,nutritional,allergen,andadditivelabeling,labelingofidentitypreservedfoods,purity,strength,andcompositionclaims,anyothercriterialistedunderfoodlegislation,andtorelevantestablishedindustrycodesofpractice.",,,

,"Themethodsandresponsibilityforensuringthesiteiskeptinformedofchangestorelevantlawsandregulations,scientificandtechnicaldevelopments,emergingfoodsafetyissues,andrelevantindustrycodesofpracticeshallbedocumentedandimplemented.",,,

,"SQFIandtheCertificationBodyshallbenotifiedinwritingwithintwenty-four(24)hoursasaresultofaregulatorywarningletteroraction,ornamedinanoutbreak.NotificationtoSQFIshallbevia/regulatory.",,,

2.4.2,GoodIndustryPractices(Mandatory),,,

,"TheGoodIndustryPractices,asidentifiedinModule17oftheSQFFoodSafetyCode,applicabletothescopeofcertificationoutlininghowfoodsafetyiscontrolledandassuredshallbedocumentedandimplemented.

Thesiteshallprovideawrittenriskassessmentoutliningthejustificationfornon-applicabilityorevidenceoftheeffectivenessofalternativecontrolmeasuresthatensurefoodsafetyisnotcompromised.",,,

2.4.3,FoodSafetyPlan(Mandatory)(CoreClause),,,

,AfoodsafetyplanshallbepreparedinaccordancewiththestepsidentifiedinthelatestversionofCodexAlimentariusCommission'sGeneralPrinciplesofFoodHygiene.ThefoodsafetyplanshallbeeffectivelyimplementedandmaintainedandshalloutlinehowthesitecontrolsandassuresfoodsafetyoftheproductsorproductgroupsincludedinthescopeoftheSQFcertificationandtheirassociatedprocesses.Morethanonefoodsafetyplanmayberequiredtocoverallproductsincludedinthescopeofcertification.,,,

,"Thefoodsafetyplanorplansshallbedevelopedandmaintainedbyamultidisciplinaryteamthatincludesthosepersonnelwithtechnical,production,andengineeringknowledgeoftherelevantrawmaterials,packaging,processingaids,products,andassociatedprocesses.Wheretherelevantexpertiseisnotavailableon-site,advicemaybeobtainedfromothersourcestoassistthefoodsafetyteam.

TheteamleadershallbeHACCPtrained.",,,

,Thescopeofeachfoodsafetyplanshallbedevelopedanddocumentedincludingthestartandendpointsoftheprocessesunderconsiderationandallrelevantinputsandoutputs.,,,

,"Productdescriptionsshallbedevelopedanddocumentedforallproductsincludedinthescopeofthefoodsafetyplans.Thedescriptionsshallreferencethefinishedproductspecifications(referto)plusanyadditionalinformationrelevanttoproductsafety,suchaspH,wateractivity,composition,and/orstorageconditions.",,,

,"Theintendeduseofeachproductshallbedeterminedanddocumentedbythefoodsafetyteam.Thisshallincludetargetconsumergroups,thepotentialforconsumptionbyvulnerablegroupsofthepopulation,requirementsforfurtherprocessingifapplicable,andpotentialalternativeusesoftheproduct.",,,

,"Thefoodsafetyteamshalldevelopanddocumentaflowdiagramcoveringthescopeofeachfoodsafetyplan.Theflowdiagramshallinclude:

i.Everystepintheprocess;

ii.Allinputstotheprocessincludingrawmaterials,packaging,andserviceinputs(e.g.,water,steam,gases);

iii.Scheduledprocessdelays;and

iv.Allprocessoutputsincludingwasteandrework.

Eachflowdiagramshallbeverifiedbythefoodsafetyteamtocoverallstagesandhoursofoperation.",,,

,Theprocessflowsforallmanufacturingprocessesshallbedesignedtoensurethatproductismanufacturedaccordingtoapprovedproductformulationstopreventcontamination.,,,

,"Thefoodsafetyteamshallidentifyanddocumentallfoodsafetyhazardsthatcanreasonablybeexpectedtooccuriningredients,inputs,rawmaterials,andeachstepoftheprocess.",,,

,"Thefoodsafetyteamshallconductahazardanalysisforeveryidentifiedhazardtodeterminewhichhazardsaresignificant,i.e.,theireliminationorreductiontoanacceptablelevelisnecessarytocontrolfoodsafety.Themethodologyfordetermininghazardsignificanceshallbedocumentedandusedconsistentlytoassessallpotentialhazardsintheabsenceofcontrol.",,,

0,"Thefoodsafetyteamshalldetermineanddocumentthecontrolmeasuresthatmustbeappliedtoallsignificanthazards.Morethanonecontrolmeasuremayberequiredtocontrolanidentifiedhazard,andmorethanonesignificanthazardmaybecontrolledbyaspecificcontrolmeasure.",,,

1,"Basedontheresultsofthehazardanalysis(referto),thefoodsafetyteamshallidentifythestepsintheprocesswherecontrolmustbeappliedtoeliminateasignificanthazardorreduceittoanacceptablelevel(i.e.,acriticalcontrolpoint(CCP)).Ininstanceswhereasignificanthazardhasbeenidentifiedatastepintheprocessbutnocontrolmeasureexists,thefoodsafetyteamshallmodifytheprocesstoincludeanappropriatecontrolmeasure.",,,

2,"ForeachidentifiedCCP,thefoodsafetyteamshallidentifyanddocumentthelimitsthatseparatesafefromunsafeproduct(criticallimits).Thefoodsafetyteamshallvalidate(referto)allcriticallimitstoensurethelevelofcontroloftheidentifiedfoodsafetyhazard(s)andthatallcriticallimitsandcontrolmeasuresindividuallyorincombinationeffectivelyprovidethelevelofcontrolrequired(referto).Criticalfoodsafetylimitsarereviewedannually,ataminimum.",,,

3,"ThefoodsafetyteamshalldevelopanddocumentprocedurestomonitorCCPstoensuretheyremainwithintheestablishedlimits(referto2).Monitoringproceduresshallidentifythepersonnelassignedtoconductmonitoring,thesamplingandtestmethods,andthetestfrequency.",,,

4,"ThefoodsafetyteamshalldevelopanddocumentdeviationproceduresthatidentifythedispositionofaffectedproductwhenmonitoringindicatesalossofcontrolataCCP.Theproceduresshallincluderootcauseanalysis,corrections,andcorrectiveandpreventativeactionstocorrecttheprocesssteptopreventrecurrenceofthesafetyfailure.",,,

5,Thedocumentedandapprovedfoodsafetyplan(s)shallbeimplementedinfullandreviewedannually.,,,

6,"Proceduresshallbeinplacetoverifythatcriticalcontrolpointsareeffectivelymonitoredandappropriaterootcauseanalysis,corrections,andcorrectiveandpreventativeactionsareapplied,asapplicable.",,,

7,"Criticalcontrolpointmonitoring,correctiveaction,andverificationrecordsshallbemaintainedandappropriatelyused.",,,

8,"Wherefoodsafetyregulationsinthecountryofproductionandintendedsale(ifknown)prescribeafoodsafetycontrolmethodologyotherthanthecurrentversionoftheCodexAlimentariusCommission'sGeneralPrinciplesofFoodHygiene,thefoodsafetyteamshallimplementfoodsafetyplansthatmeetbothCodexandfoodregulatoryrequirements.",,,

2.4.4,"Sampling,InspectionandAnalysis",,,

,"Themethods,responsibility,andcriteriaforsampling,inspecting,and/oranalyzingrawmaterials,work-in-progress,finishedproductandotherfoodsafety-relatedevaluationsshallbedocumentedandimplemented.Sampling,inspectionandanalysisshallbeconductedtonationallyrecognizedmethods.Alternativemethodsthatarevalidatedasequivalenttothenationallyrecognizedmethodscanbeused.

Themethodsappliedshallensure:

i.Inspectionsandanalysesarecompletedatregularintervalsasrequiredandtoagreedspecificationandlegalrequirements;

ii.Inspectionsand/ortestingareconductedtoensurerawmaterials,packaging,labels,work-inprogress,andfinishedproductscomplywiththerelevantspecifications,formulation/recipes,andregulatoryrequirements,andaretruetolabel;

iii.Samplingandtestingshallbestatisticallybased,representativeoftheprocess/batch,andensureproductionandprocesscontrolsaremaintainedtomeetspecificationsandformulation/recipe;and

iv.Retentionsamples,ifrequiredbycustomersorregulations,arestoredandmaintainedforthestatedshelf-lifeoftheproduct.",,,

,"InternallaboratoriesshalloperateinaccordancewiththeapplicablerequirementsofISO/IEC17025,includingproficiencytesting.",,,

,"On-sitechemicalandmicrobiologicalanalysesthatmayposearisktoproductsafetyshallbeconductedseparatefromanyfoodprocessingorhandlingactivityanddesignedtolimitaccessonlytoauthorizedpersonnel.

Signageshallbedisplayedidentifyingtheareaasarestrictedarea,accessibleonlybyauthorizedpersonnel.",,,

,"Provisionsshallbemadetoisolateandcontainallhazardouslaboratorywasteheldonthepremisesandmanageitseparatelyfromfoodwaste.Laboratorywasteoutletsshall,ataminimum,bedownstreamofdrainsthatservicefoodprocessingandhandlingareas.",,,

,"ExternallaboratoriesshallbeaccreditedtoISO/IEC17025,orequivalent.Thetestsperformedshallbeincludedonthelaboratory'sscopeofaccreditation.",,,

,"Retentionsamples,ifrequiredbycustomersorregulations,shallbestoredaccordingtothetypicalstorageconditionsfortheproductandmaintainedforthestatedshelflifeoftheproduct.",,,

2.4.5,Non-conformingMaterialsandProduct,,,

,"Theresponsibilityandmethodsoutlininghowtohandlenon-conformingproduct,rawmaterial,ingredient,work-in-progress,orpackaging,whichisdetectedduringreceipt,storage,processing,handling,ordelivery,shallbedocumentedandimplemented.Themethodsappliedshallensure:

i.Non-conformingproductisidentified,quarantined,assessed/evaluated,and/ordispositionedinamannerthatminimizestheriskofinadvertent,improperuse,orrisktotheintegrityoffinishedproduct;

ii.Non-conformingproductisreviewedforthenatureofnon-compliance,testedforconformancetospecifications,anddeterminationmadebyqualifiedperso