An Overview of Lean
and
How to Adopt Lean to Biotech
Manufacturing
ISPE
16th Annual Vendor Night Exhibit Show
March 1, 2007
Dr. Fadel Hamed
Process Owner, Operational Excellence Training and Methodology
Genentech Inc.
Presentation Objective
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Provide an overview of Lean
Introduce the 5 Principles of Lean
Review the 7 Wastes
Discuss how to adapt Lean to
Biotech
Let’s Start with a Baseline
Genesis of the Toyota Production System
Standard
Costing
Interchangeabl
e Parts
Model Variety
Eli Whitney
Mass / Batch
Jidoka
Alfred P. Sloan
S. Toyoda
Assembly Line
Waste
Elimination
System
Synchronizatio
n
Time & Motion
Division of
Labor
F. Taylor
Mass
Production
TOYOTA
PRODUCTION
SYSTEM
Taiichi Ohno
Henry Ford
Just - In - Time
Supermarket
Replenishment
Systems
K. Toyoda
Quality
E. Deming
J.M. Juran
Employee
Partnership
P. Drucker
Toyota vs. Lean- The Dinner Story
Lean is the elimination of anything not absolutely required to deliver a
quality product or service, on time, to our customers.
Some Common Opinions about Lean
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It’s a factory thing
Our business is different
We tried something like it before
It won’t work here
We are already Successful without it
It’s an excuse to take our jobs away from us
Zero inventory
Zero Defects
Is this Part of Lean Cuisine!
The Five Principles of Lean
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Specify value in the eyes of the customer
Identify the value stream and eliminate waste
Make value flow at the pull of the customer
Involve and empower employees
Continuously improve in pursuit of perfection
Lean is Customer Focused
People
Lean
Customer
Process
Strategy
Value Added Activity
 An Activity that changes the
size, shape, fit, form, or
function of material or
information (for the first time)
to meet customer demands
and requirements.
Non-Value Added Activity
 Those activities that
consume time or resources,
but do not satisfy customer
demands and requirements
The Seven Wastes (Muda)
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There are (Seven + 1) Types of Waste
Defects
Over production
Transportation
Waiting
Inventory
Motion
Non-Value Added Processing
• + People
What is a Value Stream
Sales &
Marketing
R&D
Order Entry
Engineering & Planning
Operation
MATERIAL FLOW
Finance
CUSTOMER
SUPPLIERS
INFORMATION FLOW
Balancing Push and Pull
TAKT
•The rate at which end product or
service must be produced and
delivered in order to satisfy a
defined customer demand within a
given period of time.
KANBAN
•A small card, or other visual cue,
that regulates “Pull” in the
production system by
•signaling upstream production and
delivery.
Empowering Employees
If we, as leaders, believe that our competitive success is directly related
to the output of our employees, then we are bound to the effort to
maximize the innovative potential of value driven opportunities
for our organization
Ralph Larsen
CEO J&J
Continuous Improvement
JIT
Goal:
Continuous
Improvement
Elimination
of Waste
Goal:
Customer
Satisfaction
Standard Work
Visual Factory
Standardizing
Sorting
5S
Shining
Sustaining
Storage
Lean and Capacity
The capacity of this process
DEMAND
is
here!
Where is the Capacity of
This Process?
PROCESS STEP
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2
3
4
5
6
7
 Understanding The Constraints Is Crucial To Plan Meaningful Actions
Removing Defects May not Solve Demand Issues
DEMAND
= capacity consumed by defects
PROCESS STEP
1
2
3
4
5
6
Identifying your Constraint is Key to Success
7
Stand Alone Lean and DMAIC Activities Enable us to Attack Variation and
Waste
Suppliers
Process Development
Finance
Operations
6σ
6σ
Procurement
6σ
Global
Initiatives
n
Lea
HR
Supply Chain
6σ
6σ
Distribution
5S
6σ
n
Lea
6σ
6σ
Quality
CIT
Customer
6σ
6σ
6σ
6σ
Customer Service
Lean DMAIC Integration Creates a value chain to our Customers and
Shareholders
Supply Chain
Suppliers
6σ
Quality Procurement
6σ
Finance
6σ
6σ
PD Operations CIT
6σ
Materials
6σ
Support
Global
Initiatives
6σ
6σ
Distribution
6σ
HFF/FOF
Customer
Lean in Biotech
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What Purists Say
zero defects
Zero lot size
Zero set ups
Zero lead time
Zero handling
Zero breakdowns
Zero surging
Zero Inventory
What is Real
Zero re-occurring and major defects
Optimized Lot size to meet demand
Reduce Setup time to enable efficient flow
Remove NVA and White Space to Focus on
VA
Handling between ops is minimized
Control unplanned downtime 80-20
Planned Predictable performance
Minimum inventory needed to support
business strategy
Some Final Thoughts