BRC检查表第四版.docx
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BRC检查表第四版
BRCGLOBALSTANDARDFOOD
ISSUE4-CHECKLIST
NOTES
Inthe'Met'columnthereareonlythreepossibletypesofentry:
∙'Y'(atickisanacceptablealternative)indicatingYesforcompliance
∙'N'(acrossisanacceptablealternative)indicatingNoforanoncompliance
∙'NA'indicatingthatthatrequirementisnotrelevanttothistypeofoperationandsoneither'Y'or'N'ismeaningful
Forall'N'orcrossentriesindicatinganon-conformityagainstarequirementatthelevelbeingsoughttheremustbeaCARissued.
Forall'NA'anentrymustbemadeinthechecklistandtheEvaluationReportexplainingthereasonforbeingnotapplicable.
Forclausesincompliance,itmaybeconsideredthereareopportunitiesforimprovementthatshouldbereported..
ThecommentscolumnshouldbeusedtoindicateCRITICAL/MAJOR/MINORCAR.
Clause
Requirement
M
e
t
Comments&Observations
1.
HACCPSYSTEM
Thebasisofthecompany’sfoodsafetycontrolsystemshallbeaHACCPPlanwhichshallbesystematic,comprehensive,thorough,fullyimplementedandmaintainedandshallbebasedontheCodexAlimentariusHACCPprinciplesandreferenceshallbemadetorelevantlegislation,codesofpracticeorguidelines.
FUNDAMENTAL
SeniorManagementcommitment&implementationinQMS
HACCPsystem–multidisciplineteam
Useofconsultants
Daytodaymanagement
TeamLeadercompetence
Teammemberstrainingandexperience
Supportprogrammes.QAandGMP
HACCPprinciplesused
analysis
limits
controlofCCPs
actions
andverification
Clause
Requirement
M
e
t
Comments&Observations
Riskanalysis
andseverity.
andorquantitativeevaluation
practical,effectiveandreviewed
Conformanceandcorrectiveactionrecords
2.
QUALITYMANAGEMENTSYSTEM
QualityManagementSystem-GeneralRequirements
ThecompanyshallhaveadefinedQualityManagementSysteminrelationtotheStandardthatisestablished,documented,implemented,maintained,reviewedandwhereappropriate,improved
FUNDAMENTAL
QualityPolicyStatement
Thecompanyshallhaveaclearlydefinedanddocumentedauthorisedqualitypolicystatement.
intentions
managementcommunication
ofpolicy
andreview
QualityManual
ThecompanyshallhaveaQualityManualwhichstatesthecompany’scommitmenttoqualityandhasascopewhichcoverstherequirementsofthisStandard.
methodsandpractices
Clause
Requirement
M
e
t
Comments&Observations
OrganisationalStructure,ResponsibilityandManagementAuthority.
Thecompanyshallhaveanorganisationalstructurewhichensuresjobfunction,responsibilityandreportingrelationshipsofthosestaffwhoseactivitiesaffectproductsafety,legalityandqualityareclearlydefinedanddocumented.
responsibilities
levels&jobdescriptions
Absenceofkeystaff
support&monitoringofQMS
onlegislation,foodsafety,technicaldevelopmentsetc
ofdutiesorworkinstructions
ManagementCommitment
Thecompany’sseniormanagementshallbefullycommittedtothedevelopment,implementationandimprovementoftheQualityManagementSystem.
objectives
foridentificationofsafetyorlegalissues
Documentation
CustomerFocus
Thecompany’sseniormanagementshallensurethatprocessesareinplacetodeterminetheircustomer’sneedsandexpectations,toclearlydefinetheirrequirementsandensurethattheserequirementsarefulfilled.
indicators
ManagementReview
Thecompany’sseniormanagementshallreviewtheeffectivenessoftheQualityManagementandHACCPSystemsatplannedintervals.ThereviewshallensureacriticalevaluationoftheSystems’suitability,adequacyandeffectiveness,andidentifytheneedforchange.
ofdecisions&actions
Clause
Requirement
M
e
t
Comments&Observations
toinclude
∙Audits
∙Customerfeedback
∙Processperformance
∙Productconformity
∙Preventative&correctiveactions
∙Reviewofmanagementreviews
∙ChangesonQMS
∙Recommendations
ResourceManagement
Thecompany’sseniormanagementshallprovidealltheresourcesrequiredtoimplementandimprovetheprocessesoftheQualityManagementandHACCPsystems.
InternalAudit
Thecompanyshallauditthosesystemsandprocedures,whicharecriticaltoproductsafety,legalityandqualitytoensuretheyareinplace,appropriateandcompliedwith.
offrequency
ofauditors.
ofinternalaudits,correctiveactionsandverification
tothoseconcernedcorrectiveactionsandtimescales
todemonstratecompliance
Purchasing
Thecompanyshallcontrolallitspurchasingprocesses,whicharecriticaltoproductsafety,legalityandqualitytoensureproductandservicesprocuredconformtodefinedrequirements.
ApprovalandPerformanceMonitoring
Thecompanyshalloperateproceduresforapprovalandthemonitoringofitssuppliers
supplierapprovalprocedure
Clause
Requirement
M
e
t
Comments&Observations
andstandards.
∙In-housechecks
∙Certificatesofanalysis
∙Supplierinspection
review
GeneralDocumentationRequirements
ThecompanyshalldocumentprocedurestodemonstratecompliancewiththeStandardandshallensurethatalldocumentsnecessarytodemonstratetheeffectiveoperationandcontroloftheprocessesunderpinningthiscomplianceareinplace.
Control
Thecompanyshallensurethatalldocuments,recordsanddatacriticaltothemanagementofproductsafety,legalityandqualityareinplaceandeffectivelycontrolled.
andversion
unambiguous,detail,correctapplicationandaccessible
forchangesoramendmentrecorded
documentation
ofdocumentsandrecords
companyshallensurethatappropriatespecificationsexistfor:
∙rawmaterials(includingpackagingmaterials)
∙finishedproducts
∙intermediate/semiprocessedproducts(whereappropriate)
∙anyproductsorservicewhichcouldaffecttheintegrityofthefinishedproduct
&accuracy
agreements
Clause
Requirement
M
e
t
Comments&Observations
companyshallhave,andoperateinaccordancewithwrittendetailedprocedures,instructions,andreferencedocumentstocoverallprocessescriticaltoproductsafety,legalityandquality.
unambiguousandaccessibledocument
Keeping
Thecompanyshallmaintainrecordstodemonstratetheeffectivecontrolofproductsafety,legalityandquality.
andgenuine.
review,maintenance,storageandretrieval
authorisation
CorrectiveAction
Thecompanyshallensureproceduresexisttoinvestigatethecauseofsignificantnon-conformityagainststandards,specificationsandprocedures,whicharecriticaltoproductsafety,legalityandquality.
FUNDAMENTAL
actionstaken
responsibility
responsibilityandaccountability.
Traceability
Thecompanyshallhaveasystemwiththeabilitytotracematerials(includingprimarypackagingmaterials)fromsourcethroughallstagesofprocessinganddistributionofthefinishedproducttothecustomer.
FUNDAMENTAL
AuditorNote:
UndertakeTraceabilityChallenge
testing
preservation
Clause
Requirement
M
e
t
Comments&Observations
ManagementofIncidents,ProductWithdrawalandProductRecall
Thecompanyshalleffectivelymanageincidentsandhaveeffectiveproductwithdrawalandproductrecallproceduresinplace.
guidanceonwhatconstitutesan“incident”andreportingprocedure
notification
‘ProductRecall’procedure
Appropriateness,formalisationandreview
ofprocedure
actionandreview
ComplaintHandling
Thecompanyshallhaveasystemforthemanagementofproductcomplaints.
actions
ofcomplaintdata
3.
FACTORYENVIRONMENTSTANDARDS
.
ExternalEnvironmentStandards
siteshallbelocatedandmaintainedsoastopreventcontaminationandenabletheproductionofsafeandlegalproducts.
activities
boundaries.
andGrounds
Allgroundswithinthesiteshallbefinishedandmaintainedtoanappropriatestandard.
orderandwellmaintained
andunobstructedarea.Procedures
Outsidestorage
Clause
Requirement
M
e
t
Comments&Observations
InternalEnvironmentStandards
ProductFlowandSegregation
Premisesandplantshallbedesigned,constructedandmaintainedandproceduresshallbeinplacetocontroltheriskofproductcontaminationandtocomplywithallrelevantlegislation.
FUNDAMENTAL
securityandauthorisedaccess
flow
orproceduresforcontamination
ofworking
design
segregationforspecifichandlingrequirements
riskareas
careareas
pointshighrisk/lowrisk
ofonsitelaboratory
andcleaningsegregationoftraysandutensils
space
RawMaterialHandling,Preparation,Processing,PackingandStorageareas.
Thefabricationofthesite,buildingsandfacilitiesshallbesuitablefortheintendedpurpose.
Walls
design,construction,finishandmaintenance
Floors
imperviousandmaintenance
designandmaintenance
fromlaboratories
falls
Clause
Requirement
M
e
t
Comments&Observations
Ceilings/overheads
andoverheadsdesign,construction,finishandmaintenance
tofalseceilings
Windows
windowdesign
forglasswindowbreakage.