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7 steps to avoid unannounced audits at

suppliers
Published on January 29, 2016

Dr. Peter Drechsler Following

5 0 0
General Manager/MEB - qtec services GmbH

Alittleguidelineformedicaldevicemanufacturersandtheircritical
subcontractorsandcrucialsupplierstominimizeandreducetheprobabilityand
theriskofunforeseeableoutcomesofunannouncedauditsbyNotifiedBodiesor
RegulatoryAuthorities.

Introduction

LegalbasisforunannouncedauditsaregivenintheEuropeanMedicalDevice
Directives(1)(2)(3).Therecommendationofthecommission2013/473/ECoutlines
how,whereandhowoftentheseunannouncedauditsneedtobeperformedbyNotified
Bodies.Inordertoassurethemosteffectivesafetyofmedicaldevices,theunannounced
auditscanbeconductedevenonthepremisesofcriticalsubcontractorsorcrucial
suppliers.ItisupontheNotifiedBodytodecidewheretogo(4).

Forthesakeofsimplicityafinishedproductthatoughttobeplacedonthemarketis
referredasmedicaldevice,whereasapart,semifinishedproduct,rawmaterial,service
orevenafinishedproductthatissuppliedbyacriticalsubcontractororcrucialsupplier
iscalledaproduct.The7stepsexcludesthePLMOEMsituation,becausethatis
anotherstory.

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ThepresentedwayincludessevenmajorstepsthatmightshowRegulatoryAuthorities
andNotifiedBodiesthatamanufacturerofmedicaldeviceshasfullcontrolofhis
outsourcedprocessesasrequiredbythedirectivesaswellasbyISO13485(5).
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Development of product specifications

Themanufacturermustdevelopsubstantialspecificationsoftheproductandharmonize
itwithitssuppliers.Thespecificationshouldcontainfollowingprovisionsaccordingto
ISO/FDIS13485section7.4.2(6):productspecifications,requirementsfor
productacceptance,procedures,processesandequipment,requirementsfor
qualificationofsupplierpersonnelandqualitymanagementsystem
requirements

Goal:establishholisticspecifications.

Development of Quality Assurance Agreements

BesureyouhaveQualityAssuranceAgreementswithyoursuppliers.Theformatis
free,butthereissomecontenttoconsider.Annex2ofNBOGsbestpracticeguidelists
minimumprovisionsinQAAs(7).NotifiedBodyauditorsareencouragedtoevaluate
againstthoserequirements.Inadditiondontforgettoaddprovisionsforunannounced
audits.Ifyourproductsrequirecertainprovisionsformanufacturing,storageetc.the
QAAmightbeagoodplacetodefinethoserequirements.Thisshouldbeinlinewith
yourDeviceMasterRecord.

Goal:implementsustainableandeffectiveagreements.

Auditing of relevant production processes at the supplier

Goaloftheinternalauditatthesupplieristoassurethattheregulatoryrequirementsof
thelegalmanufactureraremet.AnimplementationofaQMSaccordingtoISO13485
mightnotneeded,however,thewholeproductionchainmustcomplywiththe
regulations,ifappropriate.Consideratleastthefollowingprocessestoaudit:Goods
Incomeinspection,productionincludingIPC,finaltesting,storageanddelivery.

Goal:evidenceofcompliantproductionprocesses.

Harmonizing of final testing at the supplier with Goods-Income-Inspection of the

manufacturer

Insurethatspecificationparametersarenottestedtwiceandmaybesomeimportantor
riskassociatedparametersofthedeliveredproductsnotatall.Therefore,thefinal
testingatyoursupplierandgoodsincomeinspectionshouldbeharmonized.Thiscanbe
outlinedintheQAAortheproductspecification.

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Goal:increasethesafetyoftheproductandreducecosts.

Provision of a risk management summary report

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Haveariskmanagementsummaryreportaboutrisksassociatedwiththeproductionof
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yourproductsatyoursupplier.Describemitigationmeasuresandcontrolactivities.The
reportcanbepreparedbyyourselfduringdesigntransferorbyyourpartner.Ifitisdone
byyoursupplieryoushouldacknowledgethereport.ENISO14971requiresinsection
3.4:Thisplanshallincludeatleastthefollowing:[]f)activitiesrelatedto
collectionandreviewofrelevantproductionandpostproductioninformation
(8).

Goal:completeriskassessmentasrequiredbyENISO14971.

Guided audits

Ifyouhaveoutsourcedproductionprocesseswithhighrisktoyourmedicaldevice,it
mightbeagoodidea,toinvitetheNotifiedBodytoconsideryoursupplierduring
regularaudits.

Goal:nosurprises.

Provision of a client specific Device-History-Record

Theusualdocumentsthatweredeliveredwiththegoodsaredeliverypapersandsome
statementofcompliance.AsummaryDeviceHistoryFile,asdescribedin
21CFR820.184,fromthesuppliershowingthenecessaryinformationisafurtherstep
showingthatoutsourcedprocessesareundercontrol(9).Emphasizetraceability.

Goal:havepaperworkinhouseshowingcompliancetoyourspecifications.

If all else fails

Therearesomecaseswereyoucantavoidunannouncedauditsatsuppliers.Prominent
casesareOEMorentirelyoutsourcedproduction.

Justinthatcase,developandestablishaSOPforunannouncedauditsatyoursupplier.
Content,notexclusive:

Informationoftheclient

Assessmentofthelegitimacyoftheauditors

Suspectedsequenceoftheaudit

Handlingoftheauditors

Provisionofdocuments
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Trainingofpersonnel

Andmore

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Summary
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Thislittlearticleattemptstogivesomeguidancetosuppliermanagementinorderto
reducetheprobabilityofunannouncedauditsatyourcriticalsubcontractorsorcrucial
suppliers.Offcourse,thereamanymorethingstodoforarealgoodsupplier
management.Implementingthesevenstepsisthebeginningandyouareontheright
way.

Feel free to ask

Dr.PeterDrechsler,qtecgroup,+49173/2462720,peter.drechsler@qtecgroup.com
Dr.MichaelSchoppol,Xpuls,+49151/44041135,michael.schoppol@xpuls.de

References

1.EU.COUNCILDIRECTIVE93/42/EECof14June1993concerningmedical
devices.OJL.1993,Vol.169,p.1.

2..COUNCILDIRECTIVEof20June1990ontheapproximationofthelawsof
theMemberStatesrelatingtoactiveimplantablemedicaldevices.OJL.1990,Vol.
189,p.17.

3..DIRECTIVE98/79/ECOFTHEEUROPEANPARLIAMENTANDOFTHE
COUNCILof27October1998oninvitrodiagnosticmedicaldevices.OJL.1998,
Vol.331,p.1.

4..COMMISSIONRECOMMENDATIONof24September2013ontheauditsand
assessmentsperformedbynotifiedbodiesinthefieldofmedicaldevices.OJL.
2013,Vol.253,p.27.

5.CEN/CENELEC.ENISO13485:2012MedicaldevicesQualitymanagement
systemsRequirementsforregulatorypurposes.2012.

6.ISO/TC210.ISO/FDIS13485:2015(E)MedicaldevicesQualitymanagement
systemsRequirementsforregulatorypurposes.2015.

7.NBOG.NBOGsBestPracticeGuide:GuidanceforNotifiedBodiesauditing
suppliers.www.nbog.eu.[Online]2010.[Cited:0118,2016.]
http://www.nbog.eu/resources/NBOG_BPG_2010_1.pdf.NBOGBPG20101.

8.CEN.ENISO14971:2012MedicaldevicesApplicationofriskmanagementto
medicaldevices.2012.

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9.CodeofFederalRegulations.Title21,Volume8.01.04.2015.PART820
QUALITYSYSTEMREGULATION.21CFR820.

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