Using Lean Six Sigma to

Reduce Costs and Improve Process Performance

Ronald D. Snee

ASQ Philadelphia Section
Six Sigma Panel Discussion
January 21, 2009
2008 All rights reserved. No part of this document may be redistributed or reproduced in any form or by any means, without the prior written permission from Tunnell Consulting, Inc.
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Business Strategy and Methodology that increases
process performance resulting in:
Enhanced customer satisfaction and
Improved bottom line results ($$)
Leadership Development Tool:
"Perhaps the biggest but most unheralded benefit of Six
Sigma is its capacity to develop a cadre of great leaders
Jack Welch
What is Six Sigma?
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Deployment
Improvement
Breakthrough
Systematic,
Focused Approach
Right People:
Selected &Trained
Results:
Process &
Financial ($$)
Communication
Recognition and
Reward
Six Sigma Initiative
Reviews
Projects
Right Projects:
Linked to Business
Goals
Project Portfolio
Management
Projects:
Execution
Reviews
Closure
Sustain the Gains:
New Projects
Project Tracking and
Reporting
Methods and Tools
Process Thinking
Process Variation
Facts, Figures, Data
Define, Measure, Analyze,
Improve, Control
8 Key Tools:
Sequenced and Linked
Statistical Tools
Statistical Software
Critical Few Variables
Key Aspects of Improvement
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Management
Team
Project
Champion
Improvement
Master(MBB)
Team Leader
(BB/GB)
And Team

Functional Groups
HR, Finance, IT
Eng, QA, etc.

Improvement Project Leaders
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THE PROCESS
PROCESS
OUTPUTS
CONTROLLED
VARIABLES
CUSTOMER
PROCESS
INPUTS
UNCONTROLLED
NOISE
VARIABLES
Schematic of a Process and Its Variables
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Blend Compress Coat Package
Process Variables
Environmental Variables
API

Excipients
Ambient Temperature and Humidity
Blending and Compression Rooms
Raw Material Lot
Operators
Equipment
Blending Time and Temperature
Compression Speed and Force
Coating Air Temperature and Moisture
Water Addition
Dissolution
Content
Uniformity
Yield
Waste
Tableting Process and Its Variables
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Process
Inputs
Controlled
Variables
Uncontrolled
Variables
Critical Few Variables
Process Control and Optimization
Are Enhanced
Measure
Analyze
Improve
Control
Finding the Critical Few Variables
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Blend Compress Coat Package
Process Variables (Xs)

Environmental Variables (Xs)

API

Excipients
Ambient Temperature and Humidity
Blending and Compression Rooms
Raw Material Lot
Operators
Equipment
Blending Time and Temperature
Compression Speed and Force
Coating Air Temperature and Moisture
Water Addition
Dissolution
Content
Uniformity
Yield
Waste
Process Inputs (Xs)
Process Outputs (Ys)
Y = f (X)
Tableting Process and Its Variables
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Sense
of
Urgency
Define
Improve
Control
Results ($$)
Measure
Analyze
Data
Leadership
Teamwork
Stakeholder Building
Project Management
Six Sigma
Tools
DMAIC Process Improvement Framework
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Tool Define Measure Analyze Improve Control
Project Charter
Maps
Cause and Effect
Matrix
Capability
Analysis
Gage R&R
Failure Modes &
Effects Analysis
Multi-Vari Studies
Design of
Experiments
Control Plans and
SPC
Key Improvement Tools
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Lean Manufacturing
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Lean is a documentation of the key attributes
of the Toyota Production System
Set of principles for efficient operations
Set of tools
Focus is on:
Process improvement by
reducing waste and cycle time
Improving process flow
Lean Manufacturing
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I
WEIGHING
468Kg
BLENDING COMPRESSION COATING
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3
days
MBR REVIEW
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4 hours
65 hours
11.5 hrs 4 hrs 40 mins
44 hours
13 hours
6 hours
15 hours
10 hours

email
2-3 day
lead time 18 month
rolling forecast

Average #
of Lots per
month
= 200
Manufacturing
Daily Schedules
4-5
days
Daily Ship
Schedule
BPX
300mg
Building 5

PHILI
Yield = 99%
Setup = 150 mins
VA = 9 hrs
1 Shift
2 operators
Yield = 98%
Setup = 290 mins
VA = 8 hrs 10 mins
1 Shift
2 operators
Yield = 99%
Setup = 195 mins
VA = 705 mins
2 Shifts
2 operators
464.7Kg 454.4Kg
457.74 Kg
Building 2
Planning
Provide 3 week
projections to Mfg

WAREHOUSE
Time spent
in Bldg 2
warehouse
= 4hrs 40
mins
Yield = 100%
Setup = 60 mins
Wghing = 180 min
1 Shift
2 operators
Number of
reviews = 5

Average
Days = 5-11
68 hours
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I
I
468Kg
Planning
Setup
Batch
Record
Review
Cycle Time
Total = 289 hrs
VA = 29 hours
Value Stream Map Can Help Identify
Key Areas to Target for Improvement
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Specify value by specific product
Identify the value stream for each product
Make value flow without interruptions
Let the customer pull value from the product
Pursue perfection
Lean Principles
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Overproduction:
More than is needed and higher quality than is needed
Waiting (hang time) for machines, operators, raw
materials, etc.
Transportation of materials:
Wasted time due to unneeded product and material
movement
Process inefficiencies and waste:
Inspection, NVA Work, duplication of effort
Stock on hand (Inventory):
Work in progress and finished product used to cover for
process problems
Motion:
Unnecessary movement, multiple handoffs, continually
searching for materials, tools, supplies, etc.
Defects:
Rework, missing information, not meeting specs
Types of Waste
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Process Mapping
Value Stream
Spaghetti
Kaizen Event
5S (Sort, Store,
Shine, Standardize,
Sustain)
Mistake Proofing
Standard Work
Work Cell Design
Line Balancing
Videotaping
Rapid Changeover:
Single Minute
Exchange of Dies
(SMED)
Kanban (just in time)
Key Lean Tools
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Shift Process Average
Reduce Process
Variation
Robust Products and
Processes
Six Sigma Objectives
Lean Objectives
Improve
Process Flow
Reduce Process
Complexity
Reduce:
Waste
Non-Value
Added Work
Cycle Time
Lean Six Sigma Improves Quality, Cost, and Delivery
Improvement Objectives
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There are Opportunities Both
Within and Between Process Steps
Step A
Step B
Step C
Customer
Lean
Six Sigma
A Three Step Process
Value-Adding
Transformations
Occur WITHIN
Process Steps
Material and
Information
Flow BETWEEN
Process Steps
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Some Improvement Projects
Process Project Impact Value
BioPharm
Batch
Record
Review
Reduce Cycle
Time 35-55%
Inventory reduced $5MM
Costs reduced $200k/yr
BioPharm Improve Yield
Yield Improved
25% Market Demand Met
Solid
Dose Manuf
Improve
Quality
Process
Validated
Product Launched After
Many Year Delay
Tablet
Manuf
Reduce
Defective
Batch Rate
Batch Defect
Rate Reduced Savings $750k/yr
Tablet
Manuf
Improve
Coater
Reliability
Process
Interruptions
Reduced 67% Savings $1.7MM/yr
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Snee, R. D. (2001) Focus on Improvement, Not Training,
Quality Management Forum, Spring 2001, 7,8,16.
Snee, R. D. and R. W. Hoerl (2007) Integrating Lean and
Six Sigma A Holistic Approach, Six Sigma Forum
Magazine, May 2007, 15-21.
Snee, R. D. and R. W. Hoerl (2003) Leading Six Sigma A
Step-by-Step Guide Based on Experience with GE and
Other Six Sigma Companies, Financial Times Prentice
Hall, New York, NY. Chapters 3-4.
Snee, R. D. and R. W. Hoerl (2005) Six Sigma Beyond the
Factory Floor Deployment Strategies for Financial
Services, Health Care, and the Rest of the Real
Economy, Financial Times Prentice Hall, New York, NY.
Chapters 3-4.
References
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For Further Information, Please Contact:

Ronald D. Snee, PhD
(610) 213-5595
RonSnee@Verizon.Net