ML24159A618
| 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: |
| References | |
| Download: ML24159A618 (1) | |
Text
1 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,
Thankyouforyourquesons.ToclarifyourproposalwithrespecttoaudingourQAProgramforTransport,Ioerthe
followingexplanaon.Pleaseletmeknowhowyoufeelaboutthis.
Thereare13QualityElementsthatapplytoNordionsQAProgramasprovidedtotheNRC.Noteourlimitedscopedoes
notincludeDesignnorSpecialProcesses.ThequalityelementsidenedinIN/QA2697Z000addressspecic
compliancewith10CFR71SubpartH.ThereferencedprocedureswithinthatqualityplanarepartofNordionsoverall
qualityprogram.Someofthesearespecictoourtransportprogram,whereasothersapplyacrossallacviesat
Nordion.
Afurthercomplexitysurroundsourtransportprogram.GivenourlocaoninCanada,wearesubjecttobothCNSCand
NRCregulatoryrequirementsformanagementsystems.Toaddressthis,wehaveelectedtodocumenttwoconnected
butdisncttransportaonmanagementsystems;ourgeneraloverallprogramasdenedinIN/QA0224Z000whichis
submiedtotheCNSCaspartoftheirtransportcercaonprocessandaU.S.focusedprogramasdetailedinIN/QA
2697Z000thatisintendedtospeakto10CFRPart71SubpartHrequirements.
SpecictoaudingtheelementsinIN/QA2697Z000,ourproposalistoassesscomplianceofthefollowingelements
(specictotransport)onanannualbasis:
ControlofPurchasedMaterial,EquipmentandServices
IdentificationandControlofMaterials,PartsandComponents
InternalInspection
ControlofMeasurementandTestEquipment
Handling,StorageandShippingControl
Inspection,TestandOperatingStatus
Non-conforming Materials, Parts or Components
Corrective Action Wenotethatinexecungourcommitmentstotheabovequalityelements,wewillgeneraterecordsandaconsthat
aredirectlyauditable.OurannualauditofIN/QA2697Z000willfocusonUSbasedtransportacvies.
Weproposetoauditthesystemacelementslistedbeloweverythreeyears:
x DocumentControl x
QualityAssuranceRecords x
Audits Ourraonalebehindthe3yearcyclefortheseelementsisthatthesearewellestablished,stacprogramsat
Nordion.Wefollowanelectronicqualitymanagementprogramthatensuresallprocedures,documentaonand
drawingsarecontrolledandapprovedaccordingtoapredesignatedstructure.Thissystemalongwithourchange
controlprogramandrecordretenonproceduredeneshowwemeettheelementsofDocumentControlandQA
Records.Similarlyourinternalauditprogramsarewellestablishedanddened.Inaccordancewithourotherquality
systems(ISO9001,ISO/IEC17025andCSAN299.2)wecurrentlyperformanauditofourinternalauditprogramevery3
years.Wefeelthatassessingthesethreeelementsonatriennialbasisfallswithinagradedapproachtothe
program.Webelievethatthisauditfrequencydoesnotprovideanyaddionalrisktothesystem.
2 Addionally,IwouldaddthatNordionissubjecttoanannualexternalauditaspartofourISO9001cercaon.BSI
Group,anaccreditedthirdparty,willauditNordionsQualityManagementSystems/QMSInfrastructure(Audits,
complaints,NCMRs,customerfeedback,ManagementReview,CAPAs,andperformancemetrics))eachyear.
Ifyouhavefurtherquesonsorwouldliketodiscusspleasedonthesitatetoreachouttome.
Regards,
GregFulford
ManagerRadiationProtectionandNuclearTransportation
Nordion
447MarchRd.
Ottawa,Ont.K2K1X8
6135923400x2658