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11/12/2012
1
Personalized Medicine’s Path from Concept to Reality: How Our Lab Uses Lean to Speed the Transformation
Anthony Carter, Ph.D.Director of OperationsADx LaboratoriesNational Jewish Health
National Jewish Health and ADx Laboratories
Mycobacteriology
Pharmacokinetics
Immunology
Beryllium
ComplementMolecular Diagnostics
Microbiology
Core
ADx
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2
The Road to Personalized Medicine
• Multi-disciplinary approach
• IS-intensive
• R&D-intensive
Lean Concepts
5‐SAndonBottleneck AnalysisGemba (The Real Place)Heijunka (Level Scheduling)Hoshin Kanri (Policy Deployment)Jidoka (Autonomation)Just‐In‐Time (JIT)Kaizen (Continuous Improvement)Kanban (Pull System)Key Performance Indicator (KPI)Muda (Waste)
PDCA (Plan, Do, Check, Act)Poka‐Yoke (Error Proofing)Root Cause Analysis (RCA)Single Exchange of Die (SMED)Six Big LossesSMART GoalsStandardized WorkTakt TimeTotal Productive Maintenance (TPM)Value Stream Mapping (VSM)Visual FactoryOveral Equipment Effectiveness (OEE)
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Achievements
1.What we have accomplished in ~6 months
2.Alternate Lean approach
3.Development and creative use of Lean tools
4.Creating operational control and transparency
5.Driving continuous improvement
6.Do’s and Don’ts
Our journey begins.
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Once upon a time…..
Core
Mycobacteriology Complement Microbiology Beryllium
Immunology Pharmacokinetics MDx
Anthony Carter, Ph.D. Director of Operations
• Older LIS• Manual processes• Little automated metric collection• Individualized processes• No centralized operational visibility• Limited scalability• Limited resources
ADx Growing Pains
PRODUCTION PROBLEM
Problem: Current processes and systems lack sufficient scalability (malleability).Solution: Implement more automation….focus on LIMS.
R&D PROBLEM
Problem: R&D resources taxed at the expense of production.Solution: Devote more staff resources to R&D efforts.
Roadblock: Fixed FTE capacity….so, we can’t hire.
R&DProduction
$$
Deliverables
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Approach of LEAN
Non-value added25-45%
Value added
Non-value added
Step 3Step 2Step 1 Step 4 Step 5 Step 6
Process X
High Impact Primary Goals
1. Gain operational visibility
2. Find 10-15% FTE capacitya. Find in Productionb. Fuel the R&D engine
3. Create control systems and operational transparency
4. Drive quality and service through development of KPIs
5. Drive kaizen (continuous improvement)
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Our approach.
Traditional DMAIC Approach
Project Charter
Collect Data
Analyze DataPilot Studies
Control System
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Novel MADIC Approach
Measure, Analyze, Define, Improve, Control
• Shotgun approach • High impact in short time• Multiple areas involved• Gain quick operational visibility• Use data to target low-hanging fruit• Involve entire staff
MADIC Approach
Measure: VSM, Process Map, SWCS, Spaghetti diagram, DOWNTIME
Analyze: Analyze data to find targets
Define: Define project charter based on all data
Improve: Design pilot studies, calculate and truly understand delta
Control: Develop control systems and develop transparency
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Evolutionary stages of introduction of Lean
Measure
Spaghetti Map-motion waste-transportation waste-feet=seconds=t=$
Process Map-process flow-touchpoints-redundancies-problem areas-IS variability
SWCS-time spent/step-time bottlenecks
VSM-cycle time-queue time-lead time-FPY% (reruns)-bottlenecks-% capacity
DOWNTIME -Categorizes waste
Metrics-TAT-Failure rate/batch/sample-Control failures-Reasons for failures-Root cause for reasons-Equip, vendor, person-Operational transparency
BigDIL ReWork
0.00%
0.50%
1.00%
1.50%
2.00%
2.50%
3.00%
3.50%
4.00%
1 /26/ 20
10
1/ 27/ 2
010
1 /28/ 20
1 0
1/ 29/ 2
010
1 /30/ 20
1 0
1/31/ 2
010
2/1/2 0 10
2 /2/2 01
0
2/3/2 01
0
2 /4/2 0 10
2/5/2 01
0
2/ 6/2 0 10
2/7/2 01
0
2/ 8/2 0 10
2/9/2 01
0
2/10/ 2
0 10
2/ 11/ 2
010
2/12/ 2
0 10
2/ 13/ 2
010
2/14/ 2
0 10
2/ 15/ 2
010
2/16 / 20
10
2/17/ 2
010
2 /18/ 20
10
2/19/ 2
010
2 /20/ 20
1 0
2/21/ 2
010
2 /22/ 20
1 0
2/23/ 2
010
2 /24/ 20
1 0
2/25/ 2
0 10
% BigDIL ReWork
avg= 2.09%
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Analyze
BigDIL ReWork
0.00%
0.50%
1.00%
1.50%
2.00%
2.50%
3.00%
3.50%
4.00%
1 /26/ 20
10
1/ 27/ 2
010
1 /28/ 20
1 0
1/ 29/ 2
010
1 /30/ 20
1 0
1/31/ 2
010
2/1/2 0 10
2 /2/2 01
0
2/3/2 01
0
2 /4/2 0 10
2/5/2 01
0
2/ 6/2 0 10
2/7/2 01
0
2/ 8/2 0 10
2/9/2 01
0
2/10/ 2
0 10
2/ 11/ 2
010
2/12/ 2
0 10
2/ 13/ 2
010
2/14/ 2
0 10
2/ 15/ 2
010
2/16 / 20
10
2/17/ 2
010
2 /18/ 20
10
2/19/ 2
010
2 /20/ 20
1 0
2/21/ 2
010
2 /22/ 20
1 0
2/23/ 2
010
2 /24/ 20
1 0
2/25/ 2
0 10
% BigDIL ReWork
avg= 2.09%
Define (and begin Control)
D O W N T I M E
Project Charter(s)
Option: Categorize each PC according to Waste – similar teams and approach
Develop operational transparency and design Quality and Control Boards
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Improve
Current State Future State
vs. = ROI
Control and Quality Dashboards
Control Board: Centrally located manual magnetic board that contains a snapshot of all WIP (Work In Progress). Huddles are held.
Quality DashboardElectronic KPI board that has both leading and lagging indicators.
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Control Board – Example
Pre-Analytical Analytical Post-Analytical
Test Step 1 Step 2 Step 3 Step 1 Step 2 Step 3 Step 1 Step 2 Step 3 Metrics
1
‐Ct‐Rerun‐Reasons‐Equip issues‐FTE issues
‐Ct‐Rerun‐Reasons‐Equip issues‐FTE issues
‐Ct‐Rerun‐Reasons‐Equip issues‐FTE issues
‐Ct‐Rerun‐Reasons‐Equip issues‐FTE issues
‐Ct‐Rerun‐Reasons‐Equip issues‐FTE issues
‐Ct‐Rerun‐Reasons‐Equip issues‐FTE issues
‐Ct‐Rerun‐Reasons‐Equip issues‐FTE issues
‐Ct‐Rerun‐Reasons‐Equip issues‐FTE issues
‐Ct‐Rerun‐Reasons‐Equip issues‐FTE issues
‐TAT‐Rerun‐Reasons‐Equip issues‐FTE issues
2
3
4
5
VALUE STREAM MAPs
TB/PK Lab
MDx Lab
Control Boards
Beryllium
Complement Lab
Immunology
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Quality Dashboards
Immunology
Core
Client Services MDx
MycobacteriologyMicrobiology Beryllium
Primary Operations Dashboard
Control Board
VSM
Process Gauges
Dashboard
Control and Transparency
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How we use our Lean tools.
KPI’s, Process Maps and Root Cause Analysis
Track Frequency and Root Cause
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Process Map Permutations
And the winner is…
4 Levels of Information
1. Who is involved with the step2. What software each step touches3. Where the process takes place4. Steps/decisions in the process
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Capacity Planning….use VSMs
Total FTE Time Total Equipment
Time+ =
Total Resource Time
FTE TimeClin Process 1
FTE TimeClin Process 2
FTE TimeClin Process 3
FTE TimeClin Process 4
Equipment TimeClin Process 1
Equipment TimeClin Process 2
Equipment TimeClin Process 3
Equipment TimeClin Process 4
FTE TimeR&D
Equipment TimeR&D
+ =Total Resource Time devoted
to Clinical
+ Total Resource Time left over
for R&D
=
VSMs
-Reruns (FPY%)-Cycle Time-Queue Time-Automation
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Development of complete operations picture using VSMs will allow for appropriate resource allocation to R&D projects and drive scheduled innovation
Production: 80%
R&D: 20%
ETA on deliverables
Buy
HireBuy Buy
Hire
Operations and Innovation Initiatives
Operational Control/Process Improvements
Quality Control/Operational
Transparency
Continuous Improvement Cultural Change
Lean Six-Sigma Initiative
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LEAN Six-Sigma CultureTB
PK
MDx
Micro
Ber
Immuno
Phleb
CS
Complement
# Projects
Time
$$ Savings
Time
Mission
Vision
Strategy
Tactics
Goals
Targeted, Quantifiable, Time-Bound Goals
Departmental MAPs -time bound-measurable ROI-sets accountability
Overall Operations MAPs
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v
Do’s and Don’ts.
Things we learned
Do1. Allow creativity to flow and find new ways to use your Lean tools2. Pick and choose your metric collection wisely…don’t tax the group 3. Create timelines for delivery4. Quantitate ROI5. Perform Gemba walks6. Find your stars
Don’t1. Think of DMAIC steps as completely uni-directional (MADIC)2. Underestimate entropy3. Limit personnel involvement in Lean4. Lose momentum…celebrate small victories5. Get hung up on jargon
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Thank you very much.
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