ML24159A618

Nordions Response Email

ML24159A618
Person / Time
Site:	07100703
Issue date:	05/31/2024
From:	Fulford G Nordion
To:	Earl Love NRC/NMSS/DFM/IOB
Shared Package
ML24159A615	List: ML24159A616 ML24159A617 ML24159A618
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Download: ML24159A618 (1)

Text

From:GregFulford<Greg.Fulford@nordion.com>

Sent:Friday,May31,202412:55PM

To:EarlLove<Earl.Love@nrc.gov>

Cc:ErinColeman<Erin.Coleman@nordion.com>;RichardWassenaar<Richard.Wassenaar@nordion.com>

Subject:

[External_Sender]UpdatetoNordion'sQAProgram

HelloEarl,

Thankyouforyourques ons.Toclarifyourproposalwithrespecttoaudi ngourQAProgramforTransport,Io erthe

followingexplana on.Pleaseletmeknowhowyoufeelaboutthis.

Thereare13QualityElementsthatapplytoNordionsQAProgramasprovidedtotheNRC.Noteourlimitedscopedoes

notincludeDesignnorSpecialProcesses.Thequalityelementsiden edinIN/QA2697Z000addressspeci c

compliancewith10CFR71SubpartH.ThereferencedprocedureswithinthatqualityplanarepartofNordionsoverall

qualityprogram.Someofthesearespeci ctoourtransportprogram,whereasothersapplyacrossallac vi esat

Nordion.

Afurthercomplexitysurroundsourtransportprogram.Givenourloca oninCanada,wearesubjecttobothCNSCand

NRCregulatoryrequirementsformanagementsystems.Toaddressthis,wehaveelectedtodocumenttwoconnected

butdis ncttransporta onmanagementsystems;ourgeneraloverallprogramasde nedinIN/QA0224Z000whichis

submi edtotheCNSCaspartoftheirtransportcer ca onprocessandaU.S.focusedprogramasdetailedinIN/QA

2697Z000thatisintendedtospeakto10CFRPart71SubpartHrequirements.

Speci ctoaudi ngtheelementsinIN/QA2697Z000,ourproposalistoassesscomplianceofthefollowingelements

(speci ctotransport)onanannualbasis:

ControlofPurchasedMaterial,EquipmentandServices IdentificationandControlofMaterials,PartsandComponents InternalInspection ControlofMeasurementandTestEquipment Handling,StorageandShippingControl Inspection,TestandOperatingStatus Non-conforming Materials, Parts or Components Corrective Action

Wenotethatinexecu ngourcommitmentstotheabovequalityelements,wewillgeneraterecordsandac onsthat

aredirectlyauditable.OurannualauditofIN/QA2697Z000willfocusonUSbasedtransportac vi es.

Weproposetoauditthesystema celementslistedbeloweverythreeyears:

x DocumentControl x QualityAssuranceRecords x Audits Ourra onalebehindthe3yearcyclefortheseelementsisthatthesearewellestablished,sta cprogramsat

Nordion.Wefollowanelectronicqualitymanagementprogramthatensuresallprocedures,documenta onand

drawingsarecontrolledandapprovedaccordingtoapredesignatedstructure.Thissystemalongwithourchange

controlprogramandrecordreten onprocedurede neshowwemeettheelementsofDocumentControlandQA

Records.Similarlyourinternalauditprogramsarewellestablishedandde ned.Inaccordancewithourotherquality

systems(ISO9001,ISO/IEC17025andCSAN299.2)wecurrentlyperformanauditofourinternalauditprogramevery3

years.Wefeelthatassessingthesethreeelementsonatriennialbasisfallswithinagradedapproachtothe

program.Webelievethatthisauditfrequencydoesnotprovideanyaddi onalrisktothesystem.

1 Addi onally,IwouldaddthatNordionissubjecttoanannualexternalauditaspartofourISO9001cer ca on.BSI

Group,anaccreditedthirdparty,willauditNordionsQualityManagementSystems/QMSInfrastructure(Audits,

complaints,NCMRs,customerfeedback,ManagementReview,CAPAs,andperformancemetrics))eachyear.

Ifyouhavefurtherques onsorwouldliketodiscusspleasedonthesitatetoreachouttome.

Regards,

GregFulford

ManagerRadiationProtectionandNuclearTransportation

Nordion

447MarchRd.

Ottawa,Ont.K2K1X8

6135923400x2658

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