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.
What is Six Sigma?

 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

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 Key Aspects of Improvement

Deployment Projects Methods and Tools

 Improvement  Right Projects:  Process Thinking
 Breakthrough  Linked to Business  Process Variation
 Systematic, Goals  Facts, Figures, Data
Focused Approach  Project Portfolio  Define, Measure, Analyze,
 Right People: Management Improve, Control
 Selected &Trained  Projects:  8 Key Tools:
 Results:  Execution  Sequenced and Linked
 Process &  Reviews  Statistical Tools
Financial ($$)  Closure  Statistical Software
 Communication  Sustain the Gains:  Critical Few Variables
 Recognition and  New Projects
Reward  Project Tracking and
 Six Sigma Initiative Reporting
Reviews

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 Improvement Project Leaders

Management
Team

Improvement Project
Master(MBB) Champion

Functional Groups Team Leader

HR, Finance, IT (BB/GB)
Eng, QA, etc. And Team

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 Schematic of a Process and Its Variables
CONTROLLED
VARIABLES

PROCESS PROCESS
INPUTS THE PROCESS OUTPUTS

UNCONTROLLED CUSTOMER
NOISE
VARIABLES
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 Tableting Process and Its Variables
Process Variables
 Blending Time and Temperature
 Compression Speed and Force
 Coating Air Temperature and Moisture
 Water Addition

Dissolution
API Content
Blend Compress Coat Package Uniformity
Excipients Yield
Waste

Environmental Variables
 Ambient Temperature and Humidity
 Blending and Compression Rooms
 Raw Material Lot
 Operators
 Equipment
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 Finding the Critical Few Variables

Process Controlled Uncontrolled

Inputs Variables Variables

Measure
Analyze
Improve
Control
Critical Few Variables
Process Control and Optimization
Are Enhanced I-9
 Tableting Process and Its Variables
Process Variables (Xs)


Blending Time and Temperature
Compression Speed and Force
Y = f (X)
 Coating Air Temperature and Moisture
 Water Addition
Process Inputs (Xs) Process Outputs (Ys)
Dissolution
API Content
Blend Compress Coat Package Uniformity
Excipients Yield
Waste

Environmental Variables (Xs)

 Ambient Temperature and Humidity
 Blending and Compression Rooms
 Raw Material Lot
 Operators
 Equipment
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 DMAIC Process Improvement Framework

Sense Six Sigma

Tools
of Results ($$)

Urgency Data Control

Improve

Analyze

Measure Leadership
Teamwork
Stakeholder Building
Define Project Management I-12
 Key Improvement Tools

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
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14
Lean Manufacturing

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Lean Manufacturing

 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

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 Value Stream Map Can Help Identify
Key Areas to Target for Improvement
2-3 day
lead time Building 2 18 month
Planning
Building 5 rolling forecast PHILI
Provide 3 week
email projections to Mfg

Cycle Time Average #

of Lots per
Manufacturing Total = 289 hrs month
Daily Schedules VA = 29 hours = 200
BPX
300mg
Daily Ship
Schedule
4-5
Planning
Setup Batch
days
Record
Review
WAREHOUSE
WEIGHING BLENDING COMPRESSION COATING MBR REVIEW
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II I II
3
468Kg 457.74 Kg
468Kg 464.7Kg 454.4Kg
days

Time spent Yield = 100% Yield = 99% Yield = 98% Yield = 99%
Number of
in Bldg 2 Setup = 60 mins Setup = 150 mins Setup = 290 mins Setup = 195 mins reviews = 5
warehouse VA = 705 mins
Wghing = 180 min VA = 9 hrs VA = 8 hrs 10 mins
= 4hrs 40 Average
1 Shift 1 Shift 1 Shift 2 Shifts
mins Days = 5-11
2 operators 2 operators
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2 operators 2 operators
65 hours 44 hours 6 hours 10 hours
4 hrs 40 mins 4 hours 11.5 hrs 13 hours 15 hours 68 hours
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Lean Principles

 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

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Types of Waste
 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

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Key Lean Tools

 Process Mapping  Work Cell Design

 Value Stream  Line Balancing
 Spaghetti  Videotaping
 Kaizen Event  Rapid Changeover:
 5S (Sort, Store,  Single Minute
Shine, Standardize, Exchange of Dies
Sustain) (SMED)

 Mistake Proofing  Kanban (just in time)

 Standard Work

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 Improvement Objectives
Six Sigma Objectives Lean Objectives

Reduce:
 Shift Process Average  Waste  Improve
 Reduce Process  Non-Value Process Flow
Variation Added Work  Reduce Process
 Robust Products and  Cycle Time Complexity
Processes

Lean Six Sigma Improves Quality, Cost, and Delivery

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 There are Opportunities Both
Within and Between Process Steps

A Three Step Process Step A

Lean Step B Six Sigma

Value-Adding
Material and Step C Transformations
Information Occur WITHIN
Flow BETWEEN Process Steps
Process Steps
Customer
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 Some Improvement Projects

Process Project Impact Value

Batch
Record Reduce Cycle Inventory reduced $5MM
BioPharm Review Time 35-55% Costs reduced $200k/yr
Yield Improved
BioPharm Improve Yield 25% Market Demand Met
Solid Improve Process Product Launched After
Dose Manuf Quality Validated Many Year Delay
Reduce
Tablet Defective Batch Defect
Manuf Batch Rate Rate Reduced Savings $750k/yr
Improve Process
Tablet Coater Interruptions
Manuf Reliability Reduced 67% Savings $1.7MM/yr

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References

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.

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For Further Information, Please Contact:

Ronald D. Snee, PhD

(610) 213-5595
RonSnee@Verizon.Net

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