METHODOLOGY AND PREPARATION OF AN AUDIT Acquafondata.pdfAudit According to ISO 19011:2018 P.E.R.C....
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METHODOLOGY AND PREPARATION OF AN AUDIT
Transcript of METHODOLOGY AND PREPARATION OF AN AUDIT Acquafondata.pdfAudit According to ISO 19011:2018 P.E.R.C....
METHODOLOGYANDPREPARATIONOFANAUDIT
TheThirdQualityPillar
. Engagementofpeople:Competent, empowered and engaged people at all levelsthroughout the organization are essential to enhance theorganization’scapabilitytocreateanddelivervalue
Possibleactions:— facilitate open discussion and sharing of knowledge andexperience
ISO9000:2015
PHARMACOMITALIA
Finoal2010AuditMethodology
ISO19011:2018
CEIVPharma
EUGDP ISO13485:2016
Directive93/42/EEC(MD)/Directive98/79/EC(IVD)
SLA
QUALITYAGREEMENT
Metodologia
AuditAccordingtoISO19011:2018
P.E.R.C.
Plan
Execute
Reporting
Closeout/downfindings
6.3Preparingauditactivities
BeforeplanninganAudit
ScopeAnotherword for scope canbe«Boundary»,which setthe limits of the audit. The scope could be the entiremanagement system, or could be defined using thefollowingbroadcategories:
6.3Preparingauditactivities
Scope
Geographical:aparticularplant,officeorregion
Process:aparticularproductorservice
Temporal:Thetimeperiodcoveredbytheaudit
6.3Preparingauditactivities
BeforeplanninganAudit
Criteria
-SLAoQUALITYAGREEMENT
-EUGDP-Directive93/42/EEC(MD)/Directive98/79/EC(IVD)
-NewRegulationforMedicalDevices(MDR)EU2017/745within2020
-CEIVPHARMAoISO13485:2016
-NewRegulationforIVDDevicesIVD(IVDR)EU2017/746within2022
-Legalorregulatoryrequirements
ISO9001:2015
6.3Preparingauditactivities
BeforeplanninganAudit
ObjectiveHavingdefined the scope and criteria, theobjective ofauditistotestthesystemi.e.todeterminehowwellitmeetsthecriteriarequirementsintermsofconformity,effectiveness and efficency and could looking forimprovement
«toconducta secondpartyaudit todetermine theeffectiveimplementationofelementsofEUGDPapplicablewithintheproposed scope in accordance with quality objectivesestablishedintheSLAagreementn°XXX»
6.3Preparingauditactivities
6.3.1Documentreview
Nicetohave-QualityManual
-Organizationchart
-ManagementReview
-ExternalAuditReport/LastInternalAuditreport
6.3Preparingauditactivities
6.3.1Documentreview
TheRealworld
Atleastweneed:
OrganizationChartandProcessesflowChart
OurlastAuditreport
6.3Preparingauditactivities
6.3.2Preparingtheauditplan
Inpreparingtheplanfocuson
-RiskManagement(NewISO19011:2018)
-Auditapproach:1)“TopDown”or“downstreamaudit”2)“Upstream”
-Processestoaudit
MatrixProcessesVsRequirements(orClauses)
6.3Preparingauditactivities
6.3.2Preparingtheauditplan
Inpreparingtheplanfocuson-ProfessionalJudgment(newISO19011:2018):
1)avoidfocusingonthespecificrequirementsofeachprovisionofthestandard
2)forsomeclausesitisdifficulttofindevidenceintermsofcomparisonbetweencriteriaandcontentoftheprocedures
3)inthesesituationstheauditorshouldusehis/herprofessionaljudgmenttodetermineiftheclauseisfulfilled
6.3Preparingauditactivities
6.3.2Preparingtheauditplan
AuditTeam
Considerthescopeandmakeariskanalysisontheauditor.
AmIadequateforthisaudit?
6.3Preparingauditactivities
6.3.2Preparingtheauditplan
RISK
WhichRiskDoIhavetoconsider?
Tonotunderstandthefailures(weakness)ofthesupplier’s qualitysystem
6.3Preparingauditactivities
6.3.4Preparingworkdocument
ChecklistsBenefits:
-Ensuresauditorskeeptheprocessinmind
-Helpstomaintainthepaceofanaudit(TimeManagement)
-Assureauditeeofauditorprofessionalism
-Canbeusedasanauditcriterionforotheraudits(benchmark)
Thankyou!
