BRC检查表第四版.docx
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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
HACCPSYSTEM
Thebasisofthecompany’sfoodsafetycontrolsystemshallbeaHACCPPlanwhichshallbesystematic,comprehensive,thorough,fullyimplementedandmaintainedandshallbebasedontheCodexAlimentariusHACCPprinciplesandreferenceshallbemadetorelevantlegislation,codesofpracticeorguidelines.
FUNDAMENTAL
1.1
SeniorManagementcommitment&implementationinQMS
1.2
HACCPsystem–multidisciplineteam
Useofconsultants
Daytodaymanagement
1.3
TeamLeadercompetence
1.4
Teammemberstrainingandexperience
1.5
Supportprogrammese.g.QAandGMP
1.6
HACCPprinciplesused
1.6.1
Hazardanalysis
1.6.2
CCPs
1.6.3
Criticallimits
1.6.4
MonitoringcontrolofCCPs
1.6.5
Correctiveactions
1.6.6
Validationandverification
1.6.7
Documentation
Clause
Requirement
M
e
t
Comments&Observations
1.7
Riskanalysis
1.7.1
Occurrenceandseverity.
1.7.2
Qualitativeandorquantitativeevaluation
1.7.3
Micro-organisms
1.8
Applicability,practical,effectiveandreviewed
1.9
Conformanceandcorrectiveactionrecords
QUALITYMANAGEMENTSYSTEM
2.1
QualityManagementSystem-GeneralRequirements
ThecompanyshallhaveadefinedQualityManagementSysteminrelationtotheStandardthatisestablished,documented,implemented,maintained,reviewedandwhereappropriate,improved
FUNDAMENTAL
2.2
QualityPolicyStatement
Thecompanyshallhaveaclearlydefinedanddocumentedauthorisedqualitypolicystatement.
2.2.1
Company’sintentions
2.2.2
Seniormanagementcommunication
2.2.3
Understandingofpolicy
2.2.4
Communicationsandreview
2.3
QualityManual
ThecompanyshallhaveaQualityManualwhichstatesthecompany’scommitmenttoqualityandhasascopewhichcoverstherequirementsofthisStandard.
2.3.1
Implementation
2.3.2
Workingmethodsandpractices
2.3.3
Availability
Clause
Requirement
M
e
t
Comments&Observations
2.4
OrganisationalStructure,ResponsibilityandManagementAuthority.
Thecompanyshallhaveanorganisationalstructurewhichensuresjobfunction,responsibilityandreportingrelationshipsofthosestaffwhoseactivitiesaffectproductsafety,legalityandqualityareclearlydefinedanddocumented.
2.4.1
Directorsresponsibilities
2.4.2
Responsibilitylevels&jobdescriptions
Absenceofkeystaff
2.4.3
Informationsupport&monitoringofQMS
2.4.4
Updatesonlegislation,foodsafety,technicaldevelopmentsetc
2.4.5
Descriptionofdutiesorworkinstructions
2.5
ManagementCommitment
Thecompany’sseniormanagementshallbefullycommittedtothedevelopment,implementationandimprovementoftheQualityManagementSystem.
2.5.1
Qualityobjectives
2.5.2
Processforidentificationofsafetyorlegalissues
Documentation
2.6
CustomerFocus
Thecompany’sseniormanagementshallensurethatprocessesareinplacetodeterminetheircustomer’sneedsandexpectations,toclearlydefinetheirrequirementsandensurethattheserequirementsarefulfilled.
2.6.1
Performanceindicators
2.7
ManagementReview
Thecompany’sseniormanagementshallreviewtheeffectivenessoftheQualityManagementandHACCPSystemsatplannedintervals.ThereviewshallensureacriticalevaluationoftheSystems’suitability,adequacyandeffectiveness,andidentifytheneedforchange.
2.7.1
Records
2.7.2
Communicationofdecisions&actions
Clause
Requirement
M
e
t
Comments&Observations
2.7.3
Reviewtoinclude
∙Audits
∙Customerfeedback
∙Processperformance
∙Productconformity
∙Preventative&correctiveactions
∙Reviewofmanagementreviews
∙ChangesonQMS
∙Recommendations
2.8
ResourceManagement
Thecompany’sseniormanagementshallprovidealltheresourcesrequiredtoimplementandimprovetheprocessesoftheQualityManagementandHACCPsystems.
2.9
InternalAudit
Thecompanyshallauditthosesystemsandprocedures,whicharecriticaltoproductsafety,legalityandqualitytoensuretheyareinplace,appropriateandcompliedwith.
2.9.1
Appropriatenessoffrequency
2.9.2
Competencyofauditors.
2.9.3
Recordofinternalaudits,correctiveactionsandverification
2.9.4
Resultstothoseconcernedcorrectiveactionsandtimescales
2.9.5
Recordtodemonstratecompliance
2.10
Purchasing
Thecompanyshallcontrolallitspurchasingprocesses,whicharecriticaltoproductsafety,legalityandqualitytoensureproductandservicesprocuredconformtodefinedrequirements.
2.10.1
SupplierApprovalandPerformanceMonitoring
Thecompanyshalloperateproceduresforapprovalandthemonitoringofitssuppliers
2.10.1.1
Documentedsupplierapprovalprocedure
2.10.1.2
Exceptions
Clause
Requirement
M
e
t
Comments&Observations
2.10.1.3
Criteriaandstandards.
∙In-housechecks
∙Certificatesofanalysis
∙Supplierinspection
2.10.1.4
Performancereview
2.11
GeneralDocumentationRequirements
ThecompanyshalldocumentprocedurestodemonstratecompliancewiththeStandardandshallensurethatalldocumentsnecessarytodemonstratetheeffectiveoperationandcontroloftheprocessesunderpinningthiscomplianceareinplace.
2.11.1
DocumentationControl
Thecompanyshallensurethatalldocuments,recordsanddatacriticaltothemanagementofproductsafety,legalityandqualityareinplaceandeffectivelycontrolled.
2.11.1.1
Authorisedandversion
2.11.1.2
Legible,unambiguous,detail,correctapplicationandaccessible
2.11.1.3
Reasonsforchangesoramendmentrecorded
2.11.1.4
Obsoletedocumentation
2.11.1.5
Retentionofdocumentsandrecords
2.11.2
Specifications
Thecompanyshallensurethatappropriatespecificationsexistfor:
∙rawmaterials(includingpackagingmaterials)
∙finishedproducts
∙intermediate/semiprocessedproducts(whereappropriate)
∙anyproductsorservicewhichcouldaffecttheintegrityofthefinishedproduct
2.11.2.1
Adequacy&accuracy
2.11.2.2
Formalagreements
2.11.2.3
Reviews
Clause
Requirement
M
e
t
Comments&Observations
2.11.3
Procedures
Thecompanyshallhave,andoperateinaccordancewithwrittendetailedprocedures,instructions,andreferencedocumentstocoverallprocessescriticaltoproductsafety,legalityandquality.
2.11.3.1
Legibility,unambiguousandaccessibledocument
2.11.4
RecordKeeping
Thecompanyshallmaintainrecordstodemonstratetheeffectivecontrolofproductsafety,legalityandquality.
2.11.4.1
Legibilityandgenuine.
2.11.4.2
Collation,review,maintenance,storageandretrieval
2.11.4.3
Amendmentauthorisation
2.12
CorrectiveAction
Thecompanyshallensureproceduresexisttoinvestigatethecauseofsignificantnon-conformityagainststandards,specificationsandprocedures,whicharecriticaltoproductsafety,legalityandquality.
FUNDAMENTAL
2.12.1
Correctiveactionstaken
2.12.2
Planresponsibility
2.12.3
Documentedresponsibilityandaccountability.
2.13
Traceability
Thecompanyshallhaveasystemwiththeabilitytotracematerials(includingprimarypackagingmaterials)fromsourcethroughallstagesofprocessinganddistributionofthefinishedproducttothecustomer.
FUNDAMENTAL
AuditorNote:
UndertakeTraceabilityChallenge
2.13.1
Systemtesting
2.13.2
Identitypreservation
2.13.3
Rework
Clause
Requirement
M
e
t
Comments&Observations
2.14
ManagementofIncidents,ProductWithdrawalandProductRecall
Thecompanyshalleffectivelymanageincidentsandhaveeffectiveproductwithdrawalandproductrecallproceduresinplace.
2.14.1
Writtenguidanceonwhatconstitutesan“incident”andreportingprocedure
2.14.2
Customersnotification
2.14.3
Documented‘ProductRecall’procedure
Appropriateness,formalisationandreview
2.14.4
Testingofprocedure
2.14.5
Correctiveactionandreview
2.15
ComplaintHandling
Thecompanyshallhaveasystemforthemanagementofproductcomplaints.
2.15.1
Appropriateactions
2.15.2
Useofcomplaintdata
3.
FACTORYENVIRONMENTSTANDARDS
3.1.
ExternalEnvironmentStandards
3.1.1
Location
Thesiteshallbelocatedandmaintainedsoastopreventcontaminationandenabletheproductionofsafeandlegalproducts.
3.1.1.1
Localactivities
3.1.1.2
Siteboundaries.
3.1.2
PerimeterandGrounds
Allgroundswithinthesiteshallbefinishedandmaintainedtoanappropriatestandard.
3.1.2.1
Goodorderandwellmaintained
3.1.2.2
Cleanandunobstructedarea.Procedures
3.1.2.3
Outsidestorage
3.1.2.4
Drainage
Clause
Requirement
M
e
t
Comments&Observations
3.2
Intern
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