BRC检查表第四版.docx

BRC检查表第四版.docx

《BRC检查表第四版.docx》由会员分享，可在线阅读，更多相关《BRC检查表第四版.docx（38页珍藏版）》请在冰点文库上搜索。

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

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

2.

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