insights into the st.gallenopex and quality metrics research · 2018-01-23 · insights into the...

InsightsintotheSt.Gallen OPEXandQualityMetricsResearchGSIASSPI– NewYearEvent&NewMemberWelcomeDrink

January23,2018

Prof.Dr.ThomasFriedliNicolasPonce

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Agenda

Introduction1

St.Gallen OPEXModel&Benchmarking2

InsightsfromFDAQualityMetricsResearch3

QCLabOPEXBenchmarking4

Contact4

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TheUniversityofSt.Gallen

§ 4professorsforProductionMgmt.,InnovationMgmt.,OperationsMgmt.andEntrepreneurshipwith40+researchassociates

§ BiggestInstituteattheUniversityofSt.Gallen

§ Foundedin1898§ Ranked1stintheGermanspeakingareaintheHandelsblattrankingforbusinessmanagementresearch,Ranked4th inFTRankingEuropeanBusinessSchools

§ 39institutesand5schools(Management,EconomicsandPoliticalScience,Finance,Law,HumanitiesandSocialSciences)

§ 8.020students(25%internationalstudents),719researchassociates,93professors

UniversityofSt.Gallen(HSG)

§ LedbyProfDr. ThomasFriedli§ Currently12researchassociates§ CompetenceCenters:GlobalProductionNetworks,OperationalExcellence,andSmartManufacturing&Services

§ Highindustryfocuswith20+industry-,4+benchmarking- and4+industryrelatedresearchprojectsperyear

ProductionManagement(ITEM-PM)

ProductionManagementattheInstituteofTechnologyManagement

InstituteofTechnologyManagement(ITEM-HSG)

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DivisionofProductionManagementProf.Dr.ThomasFriedliProfessorofManagementwithspecialfocusonProductionManagement' +41(0)712247261* thomas.friedli@unisg.ch

Dr.LukasBuddeProjectLeader' +41(0)712247219* lukas.budde@unisg.ch

ManuelaLandertPersonalAssistant' +41(0)712247260*manuela.landert@unisg.ch

MichaelWiechResearchAssociate' +41(0)712247262*michael.wiech@unisg.ch

ChristianElbeResearchAssociate' +41(0)712247259* christian.elbe@unisg.ch

GlobalProduction

MarianWenkingResearchAssociate' +41(0)712247274*marian.wenking@unisg.ch

ChristophBenninghausResearchAssociate' +41(0)712247265* christoph.benninghaus@unisg.ch

DominikKohrResearchAssociate' +41(0)712247263* dominik.kohr@unisg.ch

SmartManufacturing&Services

PhilippOsterriederResearchAssociate' +41(0)712247317* philipp.osterrieder@unisg.ch

LorenzStähleResearchAssociate' +41(0)712247267* lorenz.staehle@unisg.ch

OperationalExcellence/Pharma

NicolasPonceResearchAssociate' +41(0)712247269* nicolas.ponce@unisg.ch

PaulBuessResearchAssociate' +41(0)712247272* paul.buess@unisg.ch

JulianMacuveleResearchAssociate' +41(0)712247264* julian.macuvele@unisg.ch

StephanKöhlerResearchAssociate' +41(0)712247271* stephan.koehler@unisg.ch

SteffenEichResearchAssociate' +41(0)712247273* steffen.eich@unisg.ch

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Industry

FormerandCurrentResearchandProjectPartners

Research

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Agenda

Introduction1

St.Gallen OPEXModel&Benchmarking2

InsightsfromFDAQualityMetricsResearch3

QCLabOPEXBenchmarking4

Contact4

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OurDefinitionofOperationalExcellenceTheSt.GallenunderstandingTheDivisionofProductionManagementattheUniversityofSt.GallendefinesOperationalExcellenceasaphilosophy directinganorganizationtowardscontinuousimprovement.

Itisthebalancedmanagementofcost,qualityandtimefocusingontheneedsofthecustomer.

Itcomprisesstructural&behavioralchangestosupporttheneededactivitiesthebestwaypossible.

TobesustainableithastobepushedbyTopManagementandtobedesignedtoengageeverysingleemployee.

OperationalExcellenceisnotonlyaboutperformance,itisalsoaboutthewayanorganizationachievessuperiorperformanceandabouthowit

continuouslyimprovesitself

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TheSt.GallenOperationalExcellenceModelAFrameworkforthinkingaboutOPEX

The St.GallenOPEXmodelconsistsofatechnicaland a socialsub-system

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NewTechnology-specificPerformanceAssessmentNewsegmentationbytechnologiesofpharmaceuticalmanufacturing

DrugSubstance DrugProduct&PrimaryPackaging SecondaryPackaging

Solids

Creams

Suppositories

SterileLiquids

Non-SterileLiquids

Patches

Inhalers

ChemicalAPI

Biologics

Packaging

Anaggregatedaverageoveralltechnologiesbecomesnolongernecessary!

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KeyPerformanceIndicatorsintheBenchmarkingDifferentKPIsareusedinordertogetaholisticpictureofthestatusquo

SplitintoFormulation,PrimaryPackagingandSecondaryPackaging:§ SetupandCleaning§ DedicatedEquipment§ UnplannedMaintenance§ ShiftModel&Length,LineStaffing§ OEE§ MaintenanceCostsperConversionCosts

TotalPreventativeMaintenanceKPIs

SplitintoFormulation,PrimaryPackagingandSecondaryPackaging:§ Yield§ Releasetime§ DeviationsperBatch§ DeviationClosureTime§ ReoccurringDeviation§ Cpks§ ComplaintRate(Customer)§ ComplaintRate(Supplier)§ RightFirstTime§ RejectedBatches§ Meantimebetweenfailure§ ScrapRate§ Numberoftests§ CriticalTOQuality(CTQ)§ QualityCostsperConversionCosts

TotalQualityManagementKPIs

SplitintoFormulation,PrimaryPackagingandSecondaryPackaging:§ OrderLeadTime§ ProductionLeadTime(Waiting,Production&QC/QA)

§ ReplacementTimetoCustomer§ DaysonHand(DOH)§ ServiceLevel– Delivery(OTIF)§ ServiceLevel– Supplier§ ForecastAccuracy§ ProductionScheduleAccuracy§ Priorityorders§ ProductionFreezePeriod§ NumberofStockouts§ CycleTime§ MaterialTurns(RawMaterial;Work-in-Progress;FinishedGoods)

§ ChangeoverTime(Country,Format&ProductChange)

§ NumberofChangeovers(Country,Format&ProductChange)

JustinTimeKPIs

§ ManagementLayers§ ManagementSpanofControl§ Groupwork§ FunctionalIntegration§ QuantityofSuggestions

§ QualityofSuggestionsperemployee§ EmployeeFluctuation§ SickLeave§ Overtime§ Training

§ LevelofQualification§ LevelofSafetyEffective

ManagementSystem

KPIsinthetechnicalandsocialsub-system

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WhatWeAlsoInvestigate– Enabler

TotalProductiveMaintenance

TotalQualityManagement Just-In-Time

PreventativeMaintenance

TechnologyAssessment&

Usage

Housekeeping

EffectiveManagementSystem

BasicElements

Sub-Categories

Categories

Categories,sub-categoriesandEnabler

Enabler

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ABalancedApproachforthePerformanceCalculationConsiderationofavarietyofKPIstocapturetheperformanceholistically

PerformanceCalculation

Sample Normalization Calculation

KPI1

KPI2

KPI3

…

KPIn

AllsiteKPIs AllsiteKPIsnormalized

Absolutevalues

Categorization

Perform-ance

TPM

TQM

JIT

OverallPerformancescore

PercentileRank

Categoryscores

Relativevalue(%) Scores(%) Overallscore(%)

KPI1(%)

KPI2(%)

KPI3(%)

KPI4(%)

KPI5(%)

KPIn(%)

…(%)

…(%)

….(%)

Addition*

Addition*

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OPEXBenchmarkingReport

Foreachelement(TPM,TQM,JIT,andEMS)thepersonalizedreportcomprisesmultipleKPIscomparing

youwithyourpeer-groupforeachtechnology.

Yourbenefit:Apersonalizedbenchmarkingreport

Tableof Content

TPMPerformance TQMPerformance JITPerformance

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Agenda

Introduction1

St.Gallen OPEXModel&Benchmarking2

InsightsfromFDAQualityMetricsResearch3

QCLabOPEXBenchmarking4

Contact4

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QualityMetrics

Goals§ Identify situationsinwhichtheremaybeariskfordrugsupplydisruption§ ImproveFDA’sevaluationofdrugmanufacturingandcontroloperations§ Improvetheefficiencyandeffectivenessofestablishedinspections§ FurtherdeveloptheFDA’srisk-basedinspectionscheduling

Goalsdefined/QuestionsaskedbytheFDA

Source:PresentationonDraftGuidanceforIndustry:RequestforQualityMetrics

FDAquestionstobeanswered…§ Whatisthestateofqualityinthepharmaindustry?§ Whichsitesarethehighestrisk?§ Whichproductsareatriskofshortage?§ Howdowebestutilizeourresources?§ Howdoweoptimizeinspections?§ Howdoweencouragecompaniestoimprove?

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FDAFundedQualityResearchofUniversityofSt.GallenLearningfromtheSt.GallenOPEXBenchmarkingdatabase

§ Initially,a1-yearresearchprojectonqualitymetrics

§ UniversityofSt.GallenistheonlyawardedinstitutiontodoqualityresearchforFDA

§ St.GallenOPEXBenchmarkingdatabasecomprisesnumerousqualitymetricsandstructuralfactorsforcomprehensiveanalysisthattakesintoaccountcontextcharacteristicsofdifferentPharmaCos

§ IndustryAdvisoryBoardallowsSt.Gallenprojectteamtodiscussintermediateoutcomesthroughouttheresearchperiod

WP4:Testing&Refiningofproposedmetrics- Useaccesstoindustrytocheckpracticability- Discussimplementationhurdles

WP2:STGQualityMetricsEvaluation- Developmentofa“research-driven”setofqualitymetrics- GapanalysisbetweenSt.GallenandFDAmetrics

WP1:FDAmetricsAnalysis- In-depthexaminationofcurrentFDAmetrics- Statisticalevaluationofhypotheses

WP3:Alignoutcomesanddrawconclusions- Derivemodifiedsetofmetrics- Examinationofimplementationchallenges

IndustrialAdvisoryBoardMeetings

ProjectfundofFDAwasawardedtoSt.Gallenforasecond-year tocontinueanddeepenourresearchinthefieldofQualityMetrics

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FDAFinalReportYear1

FinalReport

FinalReportforindustrywasrecentlymadeavailableduringtheISPEAnnualMeetingend-October2017

Reportavailableat

§ ManagementSummarywithkeyfindings

§ Detailedexplanationofresearchapproach,scopeandfindings

§ Outlookonsecond-yearresearchfocus

http://tectem.ch/institute/opex/fda

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PharmaceuticalProductionSystemModel- House

CAPA:CorrectiveAndPreventiveActionPQS:PharmaceuticalQualitySystem

CulturalExcellence

CAPA Effectiveness

OperationalStabilitySupplierReliability LabQuality&Robustness

PQSEfficiencyPQSEffectiveness

PQSExcellence

CustomerComplaintRate

LotAcceptanceRate/1-RejectedBatches

InvalidatedOOS

StructuralFactors

APQRon-timerate

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PharmaceuticalProductionSystemModelNextStep:ImprovingtheunderstandingofPQSExcellence

CAPA:CorrectiveAndPreventiveActionPQS:PharmaceuticalQualitySystem

CAPAEffectiveness§ NumberofCAPAs§ NumberofcriticaloverdueCAPAs§ Numberofnon-criticaloverdueCAPAs

CulturalExcellence:QualityBehavior§ Preventivemaintenance[4]§ Housekeeping[1]§ Processmanagement[1]§ Crossfunctionalproductdevelopment[1]

OperationalStability:§ UnplannedMaintenance§ OEE(average)§ Rejectedbatches§ Deviation§ Yield§ Scraprate§ Releasetime(formerlyDQ)§ Deviationclosuretime(formerlyDQ) LabQuality&Robustness:

§ AnalyticalRightFirstTime§ LabInvestigations§ InvalidatedOOS§ TotalOOS§ LabDeviationEvents§ RecurringDeviation§ CAPAsOverdue§ CustomerComplaints

RequiringInvestigation§ ProductRe-Testsdueto

Complaints§ RoutineProductRe-tests§ AnnualProductQuality

Reviews(APQR)§ APQROnTimeRate§ StabilityReports§ Audits

SupplierReliability§ Servicelevelsupplier(OTIF)§ Complaintratesupplier

CulturalExcellence:QualityMaturity§ Preventivemaintenance[3]§ Housekeeping[2]§ Processmanagement[6]§ Crossfunctionalproductdevelopment[3]§ Customerinvolvement[2]§ Supplierqualitymanagement[5]§ Set-uptimereduction[1]

PQSEffectiveness:§ Service LevelDelivery(OTIF)§ CustomerComplaintRate

PQSEfficiency:§ MaintenanceCost/TotalCost§ QualityCost/TotalCost§ CostforPreventiveMaintenance/TotalCost§ FTEQC/TotalFTE§ FTEQA/TotalFTE§ Inventory

PQSExcellence:ScorebuildfromPQSEffectiveness &PQSEfficiency

EngagementMetrics§ Suggestions(Quantity)

§ Suggestions(Quality)§ Employeeturnover

§ Sickleave§ Training§ Levelofqualification§ Levelofsafety(Incidents)

MarketComplianceKPIs:Numberofrecalls,numberofsupplystops,others(e.g.withdrawals)Regulatoryactions:Numberofwarningletters,numberof483’s,Others(e.g.FieldAlertReports),Observationofhealthauthorities

No.ofObservations:- From internal audit

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OverviewofAnalysesCompletedtoDate

PQS:PharmaceuticalQualitySystem,CAPA:CorrectiveAndPreventiveAction

PharmaceuticalProductionSystemModel- House

CulturalExcellence

CAPA Effectiveness

OperationalStabilitySupplierReliability

LabQuality&Robustness

PQSEfficiencyPQSEffectiveness

PQSExcellenceCustomerComplaintRate

LotAcceptanceRate/1-RejectedBatches

QualityBehaviorQualityMaturity

InvalidatedOOS

StructuralFactors

FDAMetrics

Intra-categoryanalysis

Inter-categoryanalysis

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ManagementSummaryofYear1FinalReport

§ PQSExcellence comprises both,PQSEffectivenessandPQSEfficiency.ApositivecorrelationbetweenthesetwoelementsofthePPSMexists.

§ ThekeyperformanceindicatorServiceLevelDelivery(OTIF)hasbeenidentifiedassuitablesurrogatefortheeffectivenessofthePharmaceuticalQualitySystem.

§ LotAcceptanceRate andCustomerComplaintRatearereasonablemeasuresforOperationalStabilityandPQSEffectiveness

§ OperationalStabilityhasasignificantimpactonPQSEffectiveness.§ SupplierReliability hasasignificantimpacton OperationalStability.§ PQSEffectivenesshighperformingsiteshaveasignificantlyhigherCulturalExcellencecomparedtoPQS

Effectivenesslowperformingsites.§ ThedevelopedStability-InventoryMatrix(ISM)allowsforabetterunderstandingoftheimpactof

inventory§ Highlevelofinventory(DaysonHand)cancompensateforstabilityissues butmaycoveraninsufficient

processcapability.§ OperationalStabilityhighperformingsites haveasignificantlylowerlevelofCustomerComplaints anda

significantlylowerlevelofRejectedBatchescomparedtoOperationalStabilitylowperformingsites.§ SiteswithlowstabilityandlowinventoryhavethehighestriskprofileregardingRejectedBatches,

CustomerComplaintRateand ServiceLevelDelivery(OTIF).

Retrievereportfrom:http://tectem.ch/institute/opex/fda

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OTIF,aSuitablePQSEffectivenessSurrogate!

1. St.Gallen BenchmarkingOn-Time-In-FulldefinitionincludesaTime,Qualityand Quantitydimension2. StatisticalconfirmationofasignificantdifferenceoftheaggregatedPQSEffectivenessbetweenOTIF

HighandLowPerformers1

1HighPerformer(HP):Top10%forOTIF,LowPerformer(LP):Bottom10%forOTIFPQS:PharmaceuticalQualitySystem

Modelinterrelations:PQSEffectivenessistheaggregationofSupplierReliabilityandOperationalStability.

Surrogatereasoning:InordertoderiveconclusionsoftheimpactofSupplierReliabilityandOperationalStabilityonPQSEffectivenessasurrogateisneeded.

Objective:IdentifyasuitableKPIasasurrogateforPQSEffectivenessthathasthesamecharacteristics.

KPIs Aggregation1 Aggregation2

§ ComplaintRateSupplier§ ServiceLevelSupplier

⬇⬆

SupplierReliability Score

AggregatedPQSScore

§ UnplannedMaintenance§ OEE§ Rejectedbatches§ Yield§ ScrapRate§ ReleaseTime§ DeviationClosureTime

⬇⬆⬇⬆⬇⬇⬇

OperationalStabilityScore

Surrogate

On-Time-In-Full (OTIF)

“Perfectorderfulfillment(percentageofordersshippedintimefromyoursite(+/- 1daysoftheagreedshipmentday)andintherightquantity(+/- 3%oftheagreedquantity)andrightquality)to

yourcustomer.”

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2DeliveryReliabilityDrivers:StabilityandInventory

Low High

High

Low

1High stability, low

inventory

2High stability, high

inventory

3Low stability, low

inventory

Stability

Inventory

4Low stability, high

inventory

Whatimpacthasinventoryontheservicedeliverylevel(OTIF)?

Inventory

§ Days-on-Hand Level(DOH) ⬆

OperationalStability

§ UnplannedMaintenance§ OEE§ Rejectedbatches§ Yield§ ScrapRate§ ReleaseTime§ DeviationClosureTime

⬇⬆⬇⬆⬇⬇⬇

DOH=30days

OS=50%

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ImpactofInventoryonServiceLevelDeliveryInventory-StabilityMatrix

Inventory(DaysonHands)

ServiceLevelDelivery(OTIF)

LowStability,LowInventorysites(3)haveasignificantlylowerServiceLevelDelivery(OTIF)comparedtoallotherpeer-groups(1,2,4)

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CustomerComplaintRateRelationInventory-StabilityMatrix

Custom

erCom

plaintRate(CCR)

OperationalStability

HighStabilitysites(1,2)havesignificantlowerCCRcomparedtoLowStabilitysites(3,4).

LowStability,LowInventory sites(3)havethehighestcomplaintrate.1

1StatisticallysignificantlyhigherCCRcomparedtoallotherpeer-groups(1,2,4).

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PQSEffectiveness– OperationalStabilityRelation

OperationalStability

PQSEffectivenessSurrogate:

ServiceLevelDelivery(OTIF)

Make-to-Stock(MtS)sitesdonotshowadependabilityonOperationalStabilitytoachieveahighPQSEffectiveness1.

Make-to-Ordersites(MtO)demonstrateanhigherPQSEffectiveness1whenthereisagreaterlevelofOperationalStability.

Doesthemake-to-strategyimpacttheeffectivenessofthePQS?

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OperationalStability,SupplierReliabilityRelationWhatistherelationbetweenOS,SRandPQSEffectiveness?

OS:OperationalStabilitySR:SupplierReliabilityTools:CorrelationAnalysis,LinearRegression

Surrogate

On-Time-In-Full (OTIF)

“Perfectorderfulfillment(percentageofordersshippedintimefromyoursite(+/- 1daysoftheagreedshipmentday)andintherightquantity(+/- 3%oftheagreedquantity)andrightquality)to

yourcustomer.”

OperationalStability

§ UnplannedMaintenance§ OEE§ Rejectedbatches§ Yield§ ScrapRate§ ReleaseTime§ DeviationClosureTime

⬇⬆⬇⬆⬇⬇⬇

SupplierReliability

§ Complaintrate(supplier)§ Servicelevelsupplier

⬇⬆

Positiverelationbetweenthesedimensions

Nodirectrelationbetweenthesedimensions

Therelationrepresentstheorderofthevaluechainfromsupplythroughoperations todelivery.

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PQSEffectiveness,EfficiencyRelationPQSEfficiency

AggregatedPQSEffectivenessPositiverelationbetweenPQSEffectiveness

andPQSEfficiencyconfirmingtheory1.

AggregatedPQSEffectiveness

§ OperationalStability§ SupplierReliability

⬆⬆

PQSEfficiency

§ MaintenanceCost/TotalCost§ QualityCost/TotalCost§ CostforPreventiveMaintenance/TotalCost§ FTEQC/TotalFTE§ FTEQA/TotalFTE

⬇⬇⬇⬇⬇

1 Ferdows andDeMeyer(1990)

Modelinterrelations:PQSEffectivenessistheaggregationofsupplierreliabilityandoperationalstability. PQSEfficiencyisdefinedbyCostandFTEEfficiency.TogetherthesedimensionsdefinePQSExcellence.

Objective:IdentifyiftheSt.Gallen dataconfirmsthetheorythatahigheffectivenessisaccompaniedwithahighefficiency. 1

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CulturalExcellenceIntroductionQualityMaturityandQualityBehaviorRelation

TPM:TotalPreventiveMaintenance,TQM:TotalQualityManagement,JIT:JustInTime,EMS:EffectiveManagementSystem

Objective:ImprovetheunderstandingofqualitymaturityandqualitybehaviorwithinpharmaceuticalcompaniesacrosstheindustryusingSt.Gallen OPEXBenchmarkingdatabase.

Researchquestion:WhatistherelationbetweenQualityMaturityandQualityBehavior?

Approach:MatchingSt.Gallen OPEXenablertoPDAdefinedcategoriesQualityMaturityandQualityBehavior.

QualityMaturity

QualityBehavior

TPMEnabler TQMEnabler JITEnabler EffectiveManagementSystem BasicElements

§ PreventiveMaintenance§ TechnologyAssessment

andUsage§ Housekeeping

§ ProcessManagement§ Cross-functionalProduct

Development§ CustomerInvolvement§ SupplierQuality

Management

§ Set-uptimeReduction§ PullProduction§ LayoutOptimization§ PlanningAdherence

§ Directionsetting§ ManagementCommitment

andCompanyCulture§ EmployeeInvolvementand

ContinuousImprovement§ FunctionalIntegrationand

Qualification

§ StandardizationandSimplification

§ VisualManagement

St.GallenEnabler

PDA

Categories

Intotal59ofmorethan100enablerswereassignedtoqualitybehaviororqualitymaturity.

Definitions

Quality Behavior:“Specificbehaviorsofindividualsintheorganizationoronsitesupportingapositivequalityculture.”QualityMaturity:“Objectivecharacteristicsofaqualitysystemthatcanbeobservedorverifieduponinspectionthathaveapositiverelationwithqualitybehavior.”

QualityBehavior QualityMaturity EngagementMetrics

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R2=0.34 AdjustedR2 =0.66

PDASurveyAnalysis20141 St.Gallen Analysis2017

QualityMaturityandBehaviorRelationTheRoleofCulturalExcellenceinthePPSM

325pharmaceuticalsitesofdifferentsizeandfocuswithinSt.Gallen databaseconfirmPDAanalysisresults.

AhigherQualityBehaviorisaccompaniedwithahigherQualityMaturity.

1 Patel,P.,Baker,D.,Burdick,R.,Chen,C.,Hill,J.,Holland,M.,&Sawant,A.(2015).QualityCultureSurveyReport.PDAJournalofPharmaceuticalScienceandTechnology,69(5),631–642.https://doi.org/10.5731/pdajpst.2015.01078

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Top10St.GallenMaturityAttributesTheseMaturityAttributesdriveQualityBehavior1. Optimizedset-upandcleaningproceduresaredocumentedasbest-practiceprocess

androlled-outthroughoutthewholeplant.2. Alargepercentageofequipmentontheshopflooriscurrentlyunderstatisticalprocess

control (SPC).3. Forrootcauseanalysiswehavestandardizedtoolstogetadeeperunderstandingof

theinfluencingfactors(e.g.DMAIC).4. Goalsandobjectivesofthemanufacturingunitarecloselylinkedandconsistentwith

corporateobjectives.Thesitehasaclearfocus.5. Wehavejointimprovementprogramswithoursupplierstoincreaseourperformance.6. Allpotentialbottleneckmachinesareidentifiedandsuppliedwithadditionalspare

parts.7. Forproductandprocesstransfersbetweendifferentunitsorsitesstandardized

proceduresexist,whichensureafast,stableandcompliedknowledgetransfer.8. Charts showingthecurrentperformancestatus(e.g.currentscrap-rates,currentup-

timesetc.)arepostedontheshop-floorandvisibleforeveryone.9. Weregularlysurveyourcustomer`srequirements.10. Werankoursuppliers,thereforeweconductsupplierqualificationsandaudits.

Totalnumberofmaturityattributes:36;StatisticalTool:Multi-LinearRegression

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What’sNext?

Source:DerivedfromQualityMetricsSession- ISPEAnnualMeetingSanDiego,CA(2017)

Industry

FDAAcademia

IndividualProjectsandOPEXResearchGroup

QualityMetricsResearch

Activeinteraction

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Agenda

Introduction1

St.Gallen OPEXModel&Benchmarking2

InsightsfromFDAQualityMetricsResearch3

QCLabOPEXBenchmarking4

Contact4

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WhyQCLabBenchmarking?

Motivation§ Inthepast,performancemeasurementwasonly/mainlyfocusedonmanufacturing

§ Inrecenttime,theawarenessforQCperformanceincreasedtremendouslyandfirstinitiativesstarted

§ MeasuringQCperformanceisdemandedacrossallpharmaceuticalcompanies

Objective§ AddresstheincreasedimportanceofQCLabperformancefortheoverallOPEXperformanceofapharmaceuticalcompany

§ Developanewbenchmarkingprojectdeducedfromthewell-establishedandindustry-testedSt.Gallen OPEXBenchmarking

Needforadifferentiatedapproach

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QCLabBenchmarkingProjectstartedbackin2016Briefintroduction

Currenteffortfocusedonroll-outofbenchmarkingexerciseacrossindustrywithinterestedpharmaceuticalcompanies(already43QClabsincurrentdatabase)

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QCLabBenchmarkingModelOperationalExcellenceinQualityControlLabs

StructuralFactorsCost

Productivity Quality Service

OverallQualityControl LabPerformance

Maintenance&QualitySystem

Planning &SteeringSystem

ManagementSystem

QCLabBenchmarkingisaholisticapproachfortheassessmentofyourLabPerformancecomprisingacomprehensivesetofdifferentfocusareasforboth,KPIsandEnabler

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KeyPerformanceIndicatorsinyourReportOverviewonperformanceKPIs

Productivity§ Handledsamples/QCFTE§ Batchesprocessed/QCFTE§ Tests/DirectQCFTE1§ Tests/Batch1§ Numberofsamplesperrun§ Dedicatedequipment§ Equipmentutilizationrate§ Stock-timeforConsumables

Quality§ LabDeviations/1’000Tests§ AnalyticalRightFirstTime1§ Investigations/1’000Tests1§ InvalidatedOOS/ConfirmedOOS1§ InvalidatedOOS/100’000Tests1§ ConfirmedOOS/100’000Tests1§ RecurringDeviation§ CAPAsOverdue§ CustomerComplaintsRequiringInvestigation/100’000Tests

§ ProductRe-TestsduetoComplaints§ AnnualProductQualityReviews(APQR)/Productstested

§ APQROnTimeRate§ ChangeControls/Batchesprocessed§ Batches/Audit§ Batches/MethodTransfer§ Batches/MethodValidation§ StabilityBatches/StabilityReport

KeyPerformanceIndicators

Service§ Leadtime1§ Cycletime1§ Releasetime1§ AdherencetoSchedule(ATS) 1§ AdherencetoLeadTime(ATL)1

1SplitintoOverallandDrugSubstancetesting,Intermediatetesting,InProcessControlTesting,RawMaterialTesting,Stability Testing,DrugProductTesting,PackagedProductTesting,MicrobialEnvironmentalTesting,MicrobialProductTesting,Component&PackagingMaterialTesting

§ SpanofControl§ ReportingLayers§ QualifiedTechnicians

§ EmployeeFluctuation§ Cross-trainedAnalysts§ GroupWork

§ Training§ SickLeave§ ShareofDirectQCFTEs1

§ OvertimeOrganization

CostEfficiency§ TotalQC/TotalQOCost§ QOCost/PlantAbsorption§ QOCost/QOFTE§ QCCost/QCFTE§ QOCost/Test§ QCCost/Test§ QCCost/Batch

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§ PreventiveMaintenance§ TechnologyAssessment&Usage§ Housekeeping§ ProcessManagement§ Standardizationand

simplification

§ ManagementCommitmentandcompanyculture

§ Employeeinvolvementandcontinuousimprovement

§ Functionalintegrationandqualification

Enabler

Maintenance&QualitySystem

Planning&SteeringSystem

ManagementSystem

Categories,subcategoriesandexample

§ Set-upreduction§ Pullapproach§ Layoutoptimization§ Planningadherence§ Visualmanagement

PreventiveMaintenance

Towhatdegreeisthereaformalprogramformaintainingyourlabequipment?

Thereisnoformal

maintenanceprogram

Formalprogramexistsbutisnotwidelyvisible

Formalprogramexistsandisvisiblebutisadheredtounevenly

Formalprogramisregularly

adheredtobutnotregularlyupdated

Formalprogramstrictlyadheredtoandupdatedregularly

Don'tknow

Intotal,weask68differentqualitativeself-assessmentquestions!

Operationalizedexamplequestion

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PersonalizedBenchmarkingReportInsightsonyourlab’sperformancecomparedtotherelevantpeer-group

ComprehensiveReportwithfocusedPerformanceAssessment

§ Management Summary with most relevant insights for Productivity,Quality and Service Performance and Enabler implementation level

§ Heat maps showing your relative performance for all KPIs§ Comparison to your peer-group median and High Performer1

§ Detailed overview on structural factors of your lab compared to peer-group

§ Charts illustrating selected efficiency distribution (e.g. cost)

1HighPerformerrepresentpeergroupofTop-QuartileforOverallLabPerformance.

Anextractofadummyreportisavailabletogetafirstimpressionoftheprojectoutcome

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QCLabOPEXBenchmarkingDatabaseOverviewasoftodayandto-beuntillateQ1/2018

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Agenda

Introduction1

St.Gallen OPEXModel&Benchmarking2

InsightsfromFDAQualityMetricsResearch3

QCLabOPEXBenchmarking4

Contact4

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UpcomingPublicationNo ChapterTitle

1 Introduction

2 UnderstandingtheimpactoftheChangingRegulatoryEnvironmentonthecGMP’sandtheIndustry

3 QualityofPharmaceuticalsandOutsourcing:UnderstandingtheinherentriskstothePatient

4 FromCompliancetoQualityExcellence:ShiftingthePharmaceuticalIndustryParadigm

5 ManagingQualityinotherindustries:LessonsforthePharmaceuticalIndustry

6 TheSt.GallenOPEXBenchmarkingModel:Understandingtheroleofperformancemeasurementindrivingcontinuousimprovement

7 TheSt.GallenQualityBenchmarkingModel:DevelopingaQualitysystemanalysis

8 ManagingbeyondCompliance:Overcomingthedividebetweenqualityandexcellencethroughintegratedsystemmanagement

9 FosteringaHealthyCultureofQuality:AchievingCulturalExcellence/Examing anExcellenceFramework– Knowing,Doing, Being

10 ManagingEffectiveOrganizationalChange

11 MeasuringandManagingQualityProactively

12 ApplicabilityoftheSt.Gallen QualitySystem model– casestudyreflection

13 ContinuousQualityImprovement

14 Itain’t 42

15 Eisai – QualitythefoundationforOPEX

16 Thestory ofJohnandhisblackbeltproject

17 Summary

18 Outlook– TheSt.GallenPharmaceuticalProductionSystemModelanditsContribution totheFDAQualityMetricsInitiative

21cQualityManagement

21cQualtiy ManagementFriedli,T.,Basu,P.K.,Mänder,C.,&Calnan,N.(2017).21cQualityManagementinthePharmaceuticalIndustry.

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Source:srf.ch(2017)

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