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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

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