Lean Six Sigma in Pharmaceutical QC Laboratories - · PDF file · 2011-09-16Lean...

Lean Six Sigma in Lean Six Sigma in Pharmaceutical QC Laboratories

Heather LongdenHeather Longden

©2011 Waters Corporation 1

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


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


Need to focus on reducing waste and variability

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


Raju, G.K., New Opportunities for Pharmaceutical Manufacturing, a 2001 presentation to FDA’s Science Board, www.pharmamanufacturing.com/whitepapers/2004/118.html

y

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


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

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.


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)


Improve Quality

Lean Labs?

Much more than just applying Spaghetti Diagrams…

Sample PreparationBalance

Computer Station & Desk

Substances

Printer


Analyzers Parts Bench

General Approach - Six Sigma DMAICpp g

DefinitionDefinition

Measurement

Analysis

Measurement

Analysis

I tImprovement

C t l


Control

Roche - Area of Impact: Laboratoriesp


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

Roche – List of Selected Projects j


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

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

Case Study -

Workflow and Documentation


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)


Low efficiency due to duplication efforts and data loss due to manual data transfer processesDefinition

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


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


3/16/2011 McCune_PittCon

Company ConfidentialCopyright © 2000 Eli Lilly and Company

Situation Before Lean Six Sigma ProjectDrag and Drop of Data g jg p


Drag and Drop of Data g p


Define: Best Practices Lab Workflow(removal of variability)( y)

Log-In

LIMS

Notebook

Analysis

SDMS

l




19

External Communication

Measure & Analyzey



Company ConfidentialCopyright © 2000 Eli Lilly and

Company

20

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




** 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,

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?




Improve: the Desired Lab Workflowp




Define: Best Practices Lab Workflow(removal of variability)( y)




24

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




•trace samples and link results (current analysis )

•find samples (future searching and data mining)

•create lab metrics (resource & project management)

The Build eLN – Vision PublisherThe Build eLN – Vision Publisher

LIMSLIMS(Nautilus)Serial

Instruments

(Balances pH)(Balances, pH)

CDS(Empower)

SDMS(NuGenesis)




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


• Repetitive Searching• eLogbook



>$3M/year

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




The Unexpected: Much longer documents

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


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”


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