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ManagementReview toDriveQualityandBusiness
Improvement
RonStellonVicePresident,QualityAssuranceAmericasRegionAstraZenecaPharmaceuticalsWilmington,DE
KathyDiemertSeniorDirector,Strategyand
Systems,GlobalQualityOperationsAstraZenecaPharmaceuticalsAlderleyPark,UK
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SessionObjectives
1.
TosharehowAstraZenecahasimplemented,viaQualityCouncils,the
ManagementReviewaspectsofICHQ10.
2.
Tosharethreereallifeexamplesofqualityandbusinessimprovementsmade
throughtheexecutionofdecisionsmadeatQualityCouncils.
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ManagementCommitment
QualityPolicy
QualityPlanning
ResourceManagement
InternalCommunications
ManagementReview
ManagementofOutsourcedActivitiesandPurchasedMaterials
ICHQ10 III:ManagementResponsibility
Leadershipisessentialtoestablishand
maintainacompanywidecommitmenttoqualityandfortheperformanceofthe
pharmaceuticalqualitysystem
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ICHQ10
III.F:ManagementReview
(a)Seniormanagementshouldberesponsibleforpharmaceuticalquality
systemgovernancethroughmanagementreviewtoensureitscontinuing
suitabilityandeffectiveness.
(b)Management
shouldassesstheconclusionsofperiodicreviewsof
processperformanceandproductqualityandofthepharmaceuticalquality
system.
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ICHQ10 IV.B.4:ManagementReviewofProcessPerformanceandProduct
Quality
Managementreviewshouldprovideassurancethatprocessperformanceand
productqualityaremanagedoverthelifecycle.Dependingonthesizeand
complexityofthecompany,managementreview
canbeaseriesofreviewsat
variouslevelsofmanagementandshouldincludeatimelyandeffective
communicationandescalationprocesstoraiseappropriatequalityissuesto
seniorlevelsofmanagementforreview.
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ProcessPerformanceandProductQualityMonitoringSystem
CorrectiveActionandPreventativeAction(CAPA)System
ChangeManagementSystem
ManagementReviewofProcessPerformanceandProductQuality
ICHQ10 IV.B:ContinualImprovementofProcessPerformanceandProduct
Quality
PharmaceuticalQualitySystemElements
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19 sites 15 countries
Supply AmericasSupply Europe, Middle East & AfricaSupply Asia Pacific & JapanSweden Operations
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ManagementOversight:AstraZenecaInterpretationofManagementReview
Element ThreeLevelsofQualityCouncils
ManagementOversighttoQualitySystemHealth/Performance
Strategic
Tactical
Status/Escalation
Manage/Monitor
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SiteQualityCouncil
RegionalQualityCouncil
GlobalQualityCouncil
QualityCouncilMembership
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Challenge:
Unfavorabletrendinlaboratorydeviations
ManagementReviewProcess:
Linemanagementescalatedtrenddataandpossiblerootcausesto
siteQuality
Council
ActionTaken:
QualityCouncilsanctionedtheformationofacrossfunctionalteamtoidentifytrue
rootcauses
Institutedawarenessoflabdeviationsimmediatelytoallstaff,
notjustafter
investigationwascompleted
Establishedavisualboardinlabtohighlightandtrackalllab
deviations
Establishedateamtofocusonerrorproofinglabdocumentation
OngoingMonitoring:
ActionplantrackedbysiteQualityCouncil
Performancemetricsreportedmonthly
Laboratorylinemanagementaccountableforsustainingandimprovingperformance
BusinessBenefit:
Improvedcycletimes/efficiencyinlab
Reductioninsiteinventorycosts(lessstockonholdduetodeviationinvestigations)
ManagementReviewCaseStudy:ImprovementinLaboratoryOperations
SiteQualityCouncil
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Challenge:
Customercomplaintprofileforkeyproductidentifiedpatientuserimprovement
opportunities
ManagementReviewProcess:
Identifiedwithinaparticularregionasanopportunityandalso
escalatedtotheglobal
QualityCouncilasaglobalopportunity
ActionTaken:
Fullreviewofcustomerfeedbackperformedresultinginimproved
patientinformation
andeducation
Proactiveworkinsomeregionswithmoreextensiveeducation
Productdesignreviewandimprovementsimplemented
Encouragementofbettercustomerfeedbackwhencomplaintsarereceived
OngoingMonitoring:
Productcomplaintprocessprovidesforevaluationofperformance
globally,regionally,
permarket,etc.
Complaintdataisregularlyreviewedandevaluatedtoensureimprovementmeasures
arebeingrealizedinthefield;reportingtoQualityCouncilis
routine
BusinessBenefit:
Retentionofcustomers
Reducedcomplaintinvestigationcosts
ManagementReviewCaseStudy:ImprovementofCustomerSatisfactionvia
ComplaintProcessReview
RegionalQualityCouncil
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Challenge:
Shippingprocessperformanceidentifiedtrendinproductlossduetotemperature
excursions
ManagementReviewProcess:
IncludedescalationtoglobalQualityCouncilforvisibilityand
supporttodriveacross
functionalglobalinitiativeforimprovement
ActionTaken:
Endtoendreviewofprocessforimprovementopportunitiesandintroductionof
moreconsistentprocesses
Globalshippingprocedureintroducedresultinginclearownershipand
accountabilitiesforexecution,oversightandperformanceevaluation
Simpleproductprotectionoptionsintroduced
Shippingrouteriskassessmentsintroduced
OngoingMonitoring:
Periodicbusinessreviewsinternallyandwithexternalproviders
andbestpractice
sharingintroduced
BusinessBenefit:
Reducedwasteandcosts
Improvedcustomerservice
ManagementReviewCaseStudy:ImprovementofthePrimaryShippingProcess
GlobalQualityCouncil
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AstraZenecaQualityCouncils
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Conclusions
Thestructureandcomplexityofyourcompanyshouldbeconsideredasyou
defineappropriatemanagementreviewmechanismsasrequiredbyICHQ10
Seniorleadershipsupportandengagementiscriticalforsuccess
ofthe
managementreviewprocess
TheICHQ10managementreviewprocesshelpsdrivecontinuous
improvementandbusinessbenefits
Management Reviewto Drive Quality and Business ImprovementSlide Number 2Slide Number 3Slide Number 4Slide Number 5Slide Number 6Slide Number 7Slide Number 8Slide Number 9Slide Number 10Slide Number 11Slide Number 12Slide Number 13Slide Number 14
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