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Lean Six Sigma inPharmaceutical QC LaboratoriesHeather Longden 2011 Waters Corporation1

Topicsp Lean Six Sigma in the Pharmaceutical Industry LeanLSixSi SigmaSiini theh AnalyticalA l i l LaboratoryL b Case Study – Improvement of Workflow and Documentation ELN for Lean Six Sigma Projects Summary 2011 Waters Corporation2

Lean Six Sigmain Pharmaceutical ManufacturinggPharmaceutical Manufacturing Independent & isolated functions, divisionsand geographical units Complex processes, many non-value addedactivities Focus on end product, not on process - high rework rates Processes to be validatedNeed to focus on reducing waste and variability 2011 Waters Corporation3

Manufacturingg and QQC CycleyTimes2520Time((Days)y )15Process TimesQC Testing Times1050ABCDEFProcess Case StudyyRaju, G.K., New Opportunities for Pharmaceutical Manufacturing, a 2001 presentation to FDA’s Science /118.html 2011 Waters Corporation4

A TypicalypPharmaceutical ProcessCycle Time ComponentsStepsIn Process/PlantIn QA/QCProcess/Unit OperationInterruption of the processSecuring of sample from processHolding of sample in plantDocumentation & verification of samplingTransferring of samples to QC LabBatching of samples in QCPreparation of test samplesActual test-separationActual test-measurementTest data collection and processingDocumentation & verification of testingTransferring results for reviewDecision regarding impact on processProcess StepManual OperationInventory HoldTesting and DocumentationRaju, G.K., New Opportunities for Pharmaceutical Manufacturing, a 2001 presentation to FDA’s Science /118.html 2011 Waters Corporation5

Strategies toIncrease Efficiencyy and QualityQyLeanIncreasing efficiency by eliminating unnecessarysteps within a process and reducing waste.Si SigmaSiSixImprove processes by eliminatingdefects and reducing variability. 2011 Waters Corporation6

Lean & Six SigmagLean Management EliminateEli inon-valueladdeddd d activitiesi i i ((waste)) Reduce complexitypflow ImproveImprove SpeedSix Sigma Reduce variation Reduce defects Reduce Cost of Poor Quality (COPQ)Improve Quality 2011 Waters Corporation7

Lean Labs?Much more than just applying Spaghetti Diagrams BalanceComputerStation& DeskSamplePreparationSubstancesPrinterAnalyzers 2011 Waters CorporationParts Bench8

General Approach- Six menttC t lControl 2011 Waters Corporation9

Roche - Area of Impact:LaboratoriespChampaneria, Nitin J., Lean Six Sigma and Operational Excellence at Roche, WCBF’s Lean & Six Sigma Summit – Chicago,June 2009 -sigma-and-operational-excellance-at-roche 2011 Waters Corporation10

Roche – List of Selected ProjectsjChampaneria, Nitin J., Lean Six Sigma and Operational Excellence at Roche, WCBF’s Lean & Six Sigma Summit – Chicago,June 2009 -sigma-and-operational-excellance-at-roche 2011 Waters Corporation11

Lean Six Sigmain the AnalyticalLabgyPharmaceutical Manufacturing QC is the bottleneck Includes repetition Easy to be streamlined andimproved by standardization High degree of reduction of manualsteps and automation“Lean Labs” will improve the overall productivity 2011 Waters CorporationAltria, Kevin D., Dufton, Ann M., Carleysmith, Stephen W., Learning from Lean Sigma, PharmTech, February 1 200912

Case Study Workflow and Documentation 2011 Waters Corporation13

Case Study –DefinitionLean Six Sigma Project in Development at Eli Lilly and Company( l b l company / US HQ / approx. 38,000(global38 000 employeesl/ 23 B Rev)R )Definition 2011 Waters CorporationLow efficiency due to duplication efforts and dataloss due to manual data transfer processes14

Case Study –Measurement/Analysisyand ImprovementpMeasurement/AnalysisLack of integration of lab workflows / informaticssystems , non-value added steps and variabilityImprovementIntroduction of Electronic Laboratory Notebookfor 300 scientists at different sites 2011 Waters Corporation15

Whyy Electronic? Increased Efficiencyy and Productivityy thus additional project capacity Improved Quality of Documentationlessens burden for compliance and IP protection lessens Cross Functional Area Searching retrieve or compilepinformation and data3/16/2011McCune PittCon 2011 Waters CorporationCompany ConfidentialCopyright 2000 Eli Lilly and Company16

SituationgProjectjDragg and BeforeDropp ofLeanDataSix Sigma 2011 Waters Corporation17

Dragg and Dropp of Data 2011 Waters Corporation18

ProjectedjLSS Value includingg Typeyp IVTask/transfer# manual stepsBaseline cost¶ –potential for Type IIType IVranking LIMS CDS56* 11K4CDS ILIMS12* 81K5Paper Notebook CDSHighly varied 540K4CDS Paper NotebookHighly varied 470K1LIMS Paper Notebook8* 46K1Paper Notebook LIMS40* 385K4SDMS LIMS63* 168K4CDS SDMS**CDS 42*eLN (3)* 17K 17K 22K2Empower (10)* 73KILIMS (5)* 28KSDMS (3)* 33KPassword re-entry due toEmpower lockouts (6)* 64K242* 2MLoginsTOTAL** a report with multiple chromatograms for multiple aliquots is created in CDS and sentto SDMS. This SDMS report is attached to all affected aliquots in LIMS¶ Includes some parallel processing3/16/2011McCune PittCon 2011 Waters CorporationCompany ConfidentialCopyright 2000 Eli Lilly and Company2 (all logins)N/A Pain /FrustrationRanking;1 lowest, 5 highest,21

Critical to Change:g What’s in it for Me? Can we Can we .minimize the impact of multiple systems?.eliminate the scientist as the data transfer step?3/16/2011McCune PittCon 2011 Waters CorporationCompany ConfidentialCopyright 2000 Eli Lilly and Company22

Meta DataRecord or generate meta data only once Transfer data from systems to auto-populate Harmonize common fields (presence and usage) ELNELNCDS (orInstrument)LIMSSubmissionMeta DataELNSDMSLIMSReportingWhat the identity, condition, and state of the samples preparation info needed to interpret results the source of the samples (project, owner)Sources User Supplied (Recorded) System generatedWhy trace samples and link results (current analysis )3/16/2011McCune PittCon 2011 Waters Corporation find samples (future searching and data mining)Confidential create lab Companymetrics (resource& projectCopyright 2000EliLilly and Companymanagement)25

Value from Paper Notebook to Electronic Measured LSS Improvements:p Issuing, Tracking, Filming and Archival of PaperSearching – Meta Data, Text, Structures, SpectraTemplates and FormsCloning ExperimentsRS232 Integrations (balances, pH meters)LIMS/ELN/CDS IntegrationCreate and Export ListsTranscription Errors Measured productivity and ROI calculation: SDMS IntegrationEmailElectronic ReferencingRepetitive SearchingeLogbook3/16/2011McCune PittCon 2011 Waters CorporationEstimated Value 3M/yearCompany ConfidentialCopyright 2000 Eli Lilly and Company27

What about the Labs? March 15,, 2010 – mandated ppaperlesspfor 3 labs June 30, 2010 – totally paperless in all labs June 30 – Steady State 1150 Documents per month Cycle Time for Documents (Experiments) 11 days withith bestb t practicesti(templates,(tl tforms,fbalanceb lintegration) Creation to Completion: 7.62 days Review Process: 3.75 daysThe Unexpected: Much longer documents3/16/2011McCune PittCon 2011 Waters CorporationCompany ConfidentialCopyright 2000 Eli Lilly and Company28

Case Study –Control and Additional BenefitsControl50% time reduction for 1150 documents/monthAdditionalBenefits Better data qqualityy – less compliancepburden Improved communication & collaboration 2011 Waters Corporation29

Summaryy Performance of the QC Laboratory impacts overall businessperformance of Pharmaceutical companiespp Major potential improvements— Reduction of production time— Cost savings— Improved product & data quality— Reduction of errors— Improved compliance— Improved communication & collaboration Achieving a “Lean Lab” 2011 Waters Corporation30

Case Study – Definition Lean Six Sigma Project in Development at Eli Lilly and Company ( l b l / US HQ / 38 000 l / 23 B R )(global company / US HQ / approx. 38,000 employees / 23 B Rev) 2011 Waters Corporat