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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* [email protected]
Dr.LukasBuddeProjectLeader' +41(0)712247219* [email protected]
ManuelaLandertPersonalAssistant' +41(0)712247260*[email protected]
MichaelWiechResearchAssociate' +41(0)712247262*[email protected]
ChristianElbeResearchAssociate' +41(0)712247259* [email protected]
GlobalProduction
MarianWenkingResearchAssociate' +41(0)712247274*[email protected]
ChristophBenninghausResearchAssociate' +41(0)712247265* [email protected]
DominikKohrResearchAssociate' +41(0)712247263* [email protected]
SmartManufacturing&Services
PhilippOsterriederResearchAssociate' +41(0)712247317* [email protected]
LorenzStähleResearchAssociate' +41(0)712247267* [email protected]
OperationalExcellence/Pharma
NicolasPonceResearchAssociate' +41(0)712247269* [email protected]
PaulBuessResearchAssociate' +41(0)712247272* [email protected]
JulianMacuveleResearchAssociate' +41(0)712247264* [email protected]
StephanKöhlerResearchAssociate' +41(0)712247271* [email protected]
SteffenEichResearchAssociate' +41(0)712247273* [email protected]
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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
37 |©ITEM-HSG
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
38 |©ITEM-HSG
§ 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
39 |©ITEM-HSG
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
41 |©ITEM-HSG
Agenda
Introduction1
St.Gallen OPEXModel&Benchmarking2
InsightsfromFDAQualityMetricsResearch3
QCLabOPEXBenchmarking4
Contact4
42 |©ITEM-HSG
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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Thankyouverymuchforyourattentionandcontributions!
Source:srf.ch(2017)
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