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Highlights from ExL Pharma’s 3rd Lean Sigma &
Kaizen for Life Sciences R&DMarch 23-24, 2010
Philadelphia, PA
Examining How Lean Concepts Help Create a Strong Company Culture:
Examples from the Healthcare Sector
Lean Healthcare is a Global Movement
Data source: visitors to www.leanhospitalsbook.com
Lean is Fundamentally About:
People doing work
People managing other people
People facing
problems
No waiting
No waste
Zero harm
Why Lean for Healthcare?
Source: an NHS hospital, UK
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Improving Radiology /MRI Access Time
Source: Children’s Medical Center, Dallas TX
The Iceberg of Lean
CultureManagement System
Philosophy
5S Kaizen
Std Work HeijunkaVSMs A3
“Equally Important Pillars” of The Toyota Way
Leader’s Job is to Develop People
Source: John Shook and Toyota
Six Sigma
Adapted from: “The Toyota” Way Fieldbook, Liker and Meier
Very fewLarge problems
FewMedium problems
ManySmall problems
MgmtKaizen
KaizenEvent
Daily Kaizen
Different Types of Kaizen
Top Down and Bottom Up
Source: Lean Hospitals, Graban
Hoshin = “compass”◦ Pointing the direction
Kanri = “management” or “control”
Hoshin Kanri◦ A process for embedding strategy and aligning an
organization toward common goals Developed by Yoji Akao (non-Toyota) Using PDCA cycles to:
◦ Create goals◦ Choose measurement points◦ Link daily activities to high level goals
Hoshin Kanri
Purpose: What’s True North?
Decrease Defects and Waiting Time by 50% each year
No. of Suggestions Implemented
Increase Productivity 10% each year
Business Engagement
Quality
Customer
Improve Safety
Inpatient
Med/Surg Telemetry
Outpatient
Clinics
Clinic A
Physician A Physician B
Clinic B
Surgery
EmergencyDept
Align Measures @ Each Level Patient &
Employee
Sprains & Strains
Patient Falls
Mindset◦ Extreme customer focus (patient)◦ Striving for perfection, not just beating benchmarks◦ Process focus, not just results◦Value Stream Map Breaking down silos◦Focus on reducing batches & delay to improve flow, not
on “working faster”◦Standardized Work Consistent, but not constraining◦Lean as “way of being” not a project or event
Management◦ Leaders as mentors and coaches, not “bosses”◦ Manager as process improver, not fire fighter◦Hoshin Kanri / Strategy Deployment Alignment of
work / goals at all levels
For Real Lean Transformation
Staffing◦ Leveling workloads, not just “dealing with it”◦ Staffing based on workload & processes, not benchmarks
(right staffing levels, not too many, not too few) Problem Solving
◦ “No problems is a problem”◦ Root cause, not workarounds◦ Suggestion System True daily kaizen and employee
engagement◦ Everyone a problem solver every day using the scientific
method (PCDA)◦ A3 Structured problem solving◦ Blame-free culture◦ Mistake proofing Culture of prevention, not
punishment
For Real Lean Transformation
Identifying Non-Value and Strengthening Clinical Processes to
Reduce Variability
What are the major challenges to the deploying Lean Sigma in clinical operations and what are effective strategies to address these challenges?
Where are the prerequisites that need to be in place before Lean Sigma becomes established in clinical operations?
3
Key Questions for theAudience and Panel
A. What are the pre-requisites?
I. Compelling Business Case “A Burning Platform”
II. Leadership SupportIII. Support OrganizationIV. Methodology to Assess Benefits
4
Response to Key Questions
The Burning Platform
The pharmaceutical industry is faced with a number of significant challenges
Increasing Cost Increasing Cycle Times Decreasing Probabilities of Success Nowhere is this more evident than in
the clinical area
5
I. Compelling Business Case
The strong, unwavering support of senior leadership is
an essential pre-requisite
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II. Leadership Support
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III. Six Sigma Organizational Structures
Six Sigma Champion
BB BB BB
Corporate Financial
Organization
Financial Analyst
Six Sigma Center of
Excellence
Master Black Belt
Independent Project
Evaluation
Six Sigma Project Execution
Consultant on Six Sigma
Methodology
ManagersEmployees
Sponsor and Staff Project
Business Function
Roles◦ Project Sponsor / Process Owner◦ Master Black Belt◦ Six Sigma Champion◦ Finance Representative
8
Six Sigma Roles and Responsibilities
In order to consistently evaluate the benefits of Six Sigma projects, you need◦ Independent evaluators that have
Appropriate training Finance/business basics Six Sigma methods
A consistent set of rules◦ Cost of running a project to measure rate of
return on Six Sigma inestment
9
IV. Methodology to Assess Benefits
B. What are the major challenges?
I. Organizational Bandwidth
II. Resistance to change
10
Response to Key Questions
Most organizations are busy with the “real work” of drug development
Difficult to find the time or energy to work on important projects
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What are the major challenges?I. Organizational Bandwidth
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No time for Six Sigma?
Too busy to change We have always done it this way This is a regulated business - you can’t just
change things
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What are the major challenges?II. Resistance to Change
All Black Belts are trained in OCM methodology
Use business sponsor to help remove these barriers
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What are the major challenges?Resistance to Change
Right Message/Messenger Acceptance across the organization that Six Sigma will address critical parts of Lilly strategy
Right People Staffing key roles with full-time, high potential leaders
Right Infrastructure IT tracking system and guidelines for HR, Finance prior to launch
Right Projects and Governance Project selection and execution aligned with company priorities and managed by accountable line organizations
Right results Robust measurement and reporting that reinforces the message and supports appropriate project selection
15
Critical Success Factors
Still have any questions? For additional information on ExL Pharma’s Lean Sigma &
Kaizen for Life Sciences R&D Conferences, please visit www.exlpharma.com
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