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Lean Six Sigma in Lean Six Sigma in Pharmaceutical QC Laboratories
Heather LongdenHeather Longden
©2011 Waters Corporation 1
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Topicsp
Lean Six Sigma in the Pharmaceutical Industry
L Si Si i h A l i l L bLean Six Sigma in the Analytical Laboratory
Case Study – Improvement of Workflow and Documentation
ELN for Lean Six Sigma ProjectsELN for Lean Six Sigma Projects
Summary
©2011 Waters Corporation 2
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Lean Six Sigma in Pharmaceutical Manufacturingg
Pharmaceutical ManufacturingPharmaceutical Manufacturing
Independent & isolated functions, divisions and geographical units
Complex processes, many non-value added activities
Focus on end product, not on process -> high rework rates
Processes to be validated
Need to focus on reducing waste and variability
©2011 Waters Corporation 3
Need to focus on reducing waste and variability
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Manufacturing and QC Cycle Times g Q y
25
20
15Time(Days)
Process Times
QC Testing Times
5
10( y ) QC Testing Times
0A CB ED F
Process Case Study
©2011 Waters Corporation 4
Raju, G.K., New Opportunities for Pharmaceutical Manufacturing, a 2001 presentation to FDA’s Science Board, www.pharmamanufacturing.com/whitepapers/2004/118.html
y
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A Typical Pharmaceutical Processyp
Steps Steps In Process/Plant In QA/QCIn Process/Plant In QA/QC
Cycle Time Components
Steps Steps In Process/Plant In QA/QCIn Process/Plant In QA/QCProcess/Unit Operation
Interruption of the process
Securing of sample from process
Holding of sample in plantHolding of sample in plant
Documentation & verification of sampling
Transferring of samples to QC Lab
Batching of samples in QC
Preparation of test samplesPreparation of test samples
Actual test-separation
Actual test-measurement
Test data collection and processing
Documentation & verification of testingDocumentation & verification of testing
Transferring results for review
Decision regarding impact on process
Process Step Testing and DocumentationInventory HoldManual Operation
©2011 Waters Corporation 5
Raju, G.K., New Opportunities for Pharmaceutical Manufacturing, a 2001 presentation to FDA’s Science Board, www.pharmamanufacturing.com/whitepapers/2004/118.html
Process Step Testing and DocumentationInventory HoldManual Operation
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Strategies to Increase Efficiency and Qualityy Q y
LeanIncreasing efficiency by eliminating unnecessary Increasing efficiency by eliminating unnecessary steps within a process and reducing waste.
Si SiSix SigmaImprove processes by eliminating defects and reducing variability.
©2011 Waters Corporation 6
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Lean & Six Sigmag
Lean Management
Eli i l dd d i i i ( )Eliminate non-value added activities (waste)
Reduce complexity
Improve flowp
Improve Speed
Six Sigma
Reduce variationReduce variation
Reduce defects
Reduce Cost of Poor Quality (COPQ)
©2011 Waters Corporation 7
Improve Quality
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Lean Labs?
Much more than just applying Spaghetti Diagrams…
Sample PreparationBalance
Computer Station & Desk
Substances
Printer
©2011 Waters Corporation 8
Analyzers Parts Bench
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General Approach - Six Sigma DMAICpp g
DefinitionDefinition
Measurement
Analysis
Measurement
Analysis
I tImprovement
C t l
©2011 Waters Corporation 9
Control
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Roche - Area of Impact: Laboratoriesp
©2011 Waters Corporation 10
Champaneria, Nitin J., Lean Six Sigma and Operational Excellence at Roche, WCBF’s Lean & Six Sigma Summit – Chicago,June 2009 http://www.sixsigmazone.com/presentations/lean-six-sigma-and-operational-excellance-at-roche
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Roche – List of Selected Projects j
©2011 Waters Corporation 11
Champaneria, Nitin J., Lean Six Sigma and Operational Excellence at Roche, WCBF’s Lean & Six Sigma Summit – Chicago,June 2009 http://www.sixsigmazone.com/presentations/lean-six-sigma-and-operational-excellance-at-roche
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Lean Six Sigma in the Analytical Labg y
Pharmaceutical ManufacturingPharmaceutical Manufacturing
QC is the bottleneck
Includes repetition
Easy to be streamlined and improved by standardization
High degree of reduction of manual steps and automation
“Lean Labs” will improve the overall productivity
©2011 Waters Corporation 12Altria, Kevin D., Dufton, Ann M., Carleysmith, Stephen W., Learning from Lean Sigma, PharmTech, February 1 2009
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Case Study -
Workflow and Documentation
©2011 Waters Corporation 13
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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 Corporation 14
Low efficiency due to duplication efforts and data loss due to manual data transfer processesDefinition
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Case Study –Measurement/Analysis and Improvementy p
Measurement/ Lack of integration of lab workflows / informatics Analysis systems , non-value added steps and variability
Introduction of Electronic Laboratory Notebook Improvement Introduction of Electronic Laboratory Notebook for 300 scientists at different sites
©2011 Waters Corporation 15
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Why Electronic?y
Increased Efficiency and Productivityy y
Improved Quality of Documentation…thus additional project capacity
lessens burden for compliance and IP protection
Cross Functional Area Searching
…lessens burden for compliance and IP protection
…retrieve or compile information and datap
©2011 Waters Corporation 16
3/16/2011 McCune_PittCon
Company ConfidentialCopyright © 2000 Eli Lilly and Company
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Situation Before Lean Six Sigma ProjectDrag and Drop of Data g jg p
©2011 Waters Corporation 17
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Drag and Drop of Data g p
©2011 Waters Corporation 18
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Define: Best Practices Lab Workflow(removal of variability)( y)
Log-In
LIMS
Notebook
Analysis
SDMS
l
©2011 Waters Corporation 19
3/16/2011 McCune_PittCon
Company ConfidentialCopyright © 2000 Eli Lilly and Company
19
External Communication
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Measure & Analyzey
©2011 Waters Corporation 20
3/16/2011 McCune_PittCon
Company ConfidentialCopyright © 2000 Eli Lilly and
Company
20
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Projected LSS Value including Type IVj g yp
Task/transfer # manual steps Baseline cost¶ –potential for Type II
Type IV ranking◊
LIMS → CDS 56* ~$11K 4
CDS → ILIMS 12* ~$81K 5
Paper Notebook → CDS Highly varied ~$540K 4
CDS → Paper Notebook Highly varied ~$470K 1
LIMS → Paper Notebook 8* ~$46K 1
Paper Notebook → LIMS 40* ~$385K 4
SDMS → LIMS 63* ~$168K 4
CDS SDMS** 42* $17K 2CDS→ SDMS** 42* ~$17K 2
Logins eLN (3)*
Empower (10)*
ILIMS (5)*
~$22K
~$73K
~$28K
2 (all logins)
SDMS (3)*
Password re-entry due to Empower lockouts (6)*
~$33K
~$64K
TOTAL 242* $2M N/A
©2011 Waters Corporation 21
3/16/2011 McCune_PittCon
Company ConfidentialCopyright © 2000 Eli Lilly and Company
** a report with multiple chromatograms for multiple aliquots is created in CDS and sent to SDMS. This SDMS report is attached to all affected aliquots in LIMS¶ Includes some parallel processing
◊Pain /Frustration Ranking; 1= lowest, 5 = highest,
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Critical to Change: What’s in it for Me?g
Can we…
Can we…
...minimize the impact of multiple systems?
...eliminate the scientist as the data transfer step?
©2011 Waters Corporation 22
3/16/2011 McCune_PittCon
Company ConfidentialCopyright © 2000 Eli Lilly and Company
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Improve: the Desired Lab Workflowp
©2011 Waters Corporation 23
3/16/2011 McCune_PittCon
Company ConfidentialCopyright © 2000 Eli Lilly and Company
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Define: Best Practices Lab Workflow(removal of variability)( y)
©2011 Waters Corporation 24
3/16/2011 McCune_PittCon
Company ConfidentialCopyright © 2000 Eli Lilly and Company
24
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Meta Data
• Record or generate meta data only once • Transfer data from systems to auto-populate
• Harmonize common fields (presence and usage)
ELN ELN ELN
• Harmonize common fields (presence and usage)
LIMSSubmission
CDS (or Instrument) SDMS LIMS
ReportingMeta DataWhat
•the identity, condition, and state of the samples
•preparation info needed to interpret results
•the source of the samples (project, owner)
SourcesSources
•User Supplied (Recorded)
•System generated
Why
©2011 Waters Corporation 25
3/16/2011 McCune_PittCon
Company ConfidentialCopyright © 2000 Eli Lilly and Company
•trace samples and link results (current analysis )
•find samples (future searching and data mining)
•create lab metrics (resource & project management)
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The Build eLN – Vision PublisherThe Build eLN – Vision Publisher
LIMSLIMS(Nautilus)Serial
Instruments
(Balances pH)(Balances, pH)
CDS(Empower)
SDMS(NuGenesis)
©2011 Waters Corporation 26
3/16/2011 McCune_PittCon
Company ConfidentialCopyright © 2000 Eli Lilly and Company
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Value from Paper Notebook to ElectronicValue from Paper Notebook to Electronic
Measured LSS Improvements:p• Issuing, Tracking, Filming and Archival of Paper • Searching – Meta Data, Text, Structures, Spectra• Templates and Forms• Cloning Experiments• RS232 Integrations (balances, pH meters)• LIMS/ELN/CDS Integration • Create and Export Lists • Create and Export Lists • Transcription Errors
Measured productivity and ROI calculation:Measured productivity and ROI calculation:• SDMS Integration• Email• Electronic Referencing
Estimated Value >$3M/year
©2011 Waters Corporation 27
• Repetitive Searching• eLogbook
3/16/2011 McCune_PittCon
Company ConfidentialCopyright © 2000 Eli Lilly and Company
>$3M/year
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What about the Labs?
March 15, 2010 – mandated paperless for 3 labs, p pJune 30, 2010 – totally paperless in all labs
June 30 – Steady State = 1150 Documents per monthJune 30 Steady State = 1150 Documents per month
Cycle Time for Documents (Experiments) = ~11 daysith b t ti (t l t f b l with best practices (templates, forms, balance
integration)Creation to Completion: 7.62 daysReview Process: 3.75 days
The Unexpected: Much longer documents
©2011 Waters Corporation 28
3/16/2011 McCune_PittCon
Company ConfidentialCopyright © 2000 Eli Lilly and Company
The Unexpected: Much longer documents
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Case Study –Control and Additional Benefits
Control 50% time reduction for 1150 documents/monthControl 50% time reduction for 1150 documents/month
Additional Better data quality –> less compliance burden Benefits
q y pImproved communication & collaboration
©2011 Waters Corporation 29
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Summaryy
Performance of the QC Laboratory impacts overall business performance of Pharmaceutical companiesp p
Major potential improvements— Reduction of production time
— Cost savings
— Improved product & data quality
— Reduction of errorsReduction of errors
— Improved compliance
— Improved communication & collaboration
Achieving a “Lean Lab”
©2011 Waters Corporation 30