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Contents NOVEMBER 2007 I VOLUME 40 NUMBER 11

F E AT U R E S
PROCESS IMPROVEMENT

18 Exercise a Process Improvement

Approach for Your Own Wellness
The process thinking and process management at the heart of
any fitness plan will help you achieve your goals and maintain
a healthy lifestyle.
JEAN HARVEY, professor at the University of Quebec, Montreal

25 Eight Steps to Sustain Change

Perhaps the most important step in any improvement project
occurs after the fact—making sure the improvements stick.
JOHN R. SCHULTZ, management consultant, West Bend, WI

AUDITING

32 Improving the Internal Audit Experience

Internal audits can be strange and stressful if employees don’t
know what to expect. One company trained its employees
to handle these activities.
THERESA WASCHE, lead internal auditor, Cerner Corp., Kansas City, MO

NANCY SCIORTINO, senior regulatory affairs specialist and audit leader, Cerner Corp.

37 Turbocharge Your Preventive Action System

A layered process audit amplifies the power of problem solving
systems. From there, continuous improvement becomes routine.
MURRAY J. SITTSAMER, president, Luminous Group, Farmington Hills, MI
C H E C K O U T
MICHAEL R. OXLEY, quality manager, BorgWarner, Muncie, IN
The ASQ website!
VISIT WILLIAM O’HARA, consultant, Canton, MI

www.asq.org
TEAMS
• Web Watch.
• Author guidelines. 43 Quality Tools, Teamwork Lead to
• Searchable database of ASQ A Boeing System Redesign
abstracts.
A project team at Boeing used various quality tools to redesign
• Index of back issues. the C-17’s fuel system and make the Air Force’s plane more
For ASQ members only: dependable.
• Salary surveys from 1995 to 2006. NICOLE ADRIAN, contributing editor

• Complete feature articles since 1995.

• QP Discussion Board.
• Back to Basics in Spanish
D E PA R T M E N T S QualityProgress
6 Up Front TABLE OF CONTACTS
Quality gets personal.
Mail
Quality Progress/ASQ
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Telephone Fax
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E-mail
10 Keeping Current Voting standards guidance sent
Follow protocol of first initial and full last name
followed by @asq.org (for example, vfunk@
ISO tells Microsoft ‘no’ ... ASQ to Election Commission p.15 asq.org).
conference speakers announced
Article Submissions
... Voting standards reviewed ... Quality Progress is a peer-reviewed publication
more. with 85% of its feature articles written by quali-
59 QP Toolbox ty professionals. For information about submit-
ting an article, call Valerie Funk at 800-248-1946

51 Quality in the First x7373, or e-mail manuscripts@asq.org.

Person 64 QP Reviews Free QP Live

Subscribe to our free electronic newsletter,
One person’s quality journey
begins in the insurance 66 QP Calendar
QP Live, for a summary of each issue’s
contents. Visit www.asq.org/keepintouch.html,
industry. or contact ASQ customer care at help@asq.org.

72 Back to Basics Photocopying Authorization

53 Measure for Measure Zero defect sampling.
Authorization to photocopy items for internal or
personal use or the internal or personal use of
Calibration—the good, the bad specific clients is granted by Quality Progress pro-
vided the fee of $1 per copy is paid to ASQ or the
and the ugly. Copyright Clearance Center, 222 Rosewood Dr.,
SPECIAL FEATURE: Danvers, MA 01923, 978-750-8400. Copying for
other purposes requires the express permission
55 Career Corner 60 ASQ’s Organizational and
of Quality Progress. For permission, write Alice
Haley, PO Box 3005, Milwaukee, WI 53201-3005,
Turning the tables: Six Sustaining Members call 414-272-8575 x7406, fax 414-272-1734 or
questions to ask your e-mail ahaley@asq.org.
interviewer.
Photocopies, Reprints
And Microform
Next Month:
56 Standards Outlook
Article photocopies are available from ASQ at
800-248-1946. To purchase bulk reprints (more
Auto industry drives to
Salary Survey than 100), contact Barbara Mitrovic at ASQ,
800-248-1946. For microform, contact ProQuest
improve healthcare.
Information and Learning, 300 N. Zeeb Road,
Ann Arbor, MI 48106, 800-521-0600 x2888, inter-
national 734-761-4700, www.il.proquest.com.

Membership and Subscriptions

For more than 60 years, ASQ has been the
worldwide provider of information and learning
ASQ’s Vision • By making quality a global priority, an organizational imperative and opportunities related to quality. In addition, ASQ
a personal ethic, the American Society for Quality becomes the community for everyone membership offers information, networking, cer-
who seeks quality technology, concepts or tools to improve themselves and their world. tification and educational opportunities to help
quality professionals obtain practical solutions to
Student, Associate, Canadian includes
ANNUAL SUBSCRIPTION and Forum/Division Forum/Division Forum/Division first-class delivery. the many problems they face each day. Sub-
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ed with a regular ASQ tion on p. 50 of this issue.
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List Rentals
Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203. Orders for ASQ’s member and nonmember
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Postmaster: Please send address changes to the American Society for Quality, PO Box 3005, Milwaukee, WI 53201-3005. Printed in USA.

4 I NOVEMBER 2007 I www.asq.org

UPFRONT
QualityProgress

Quality Gets Personal Publisher

WILLIAM A. TONY

Editor
n ounce of prevention is worth a pound of cure.” SEICHE SANDERS
“A The author of this month’s cover story leads off with the adage, Associate Editor
MARK EDMUND
appropriate for an article that draws a cogent parallel between process
Assistant Editor
improvement applied to quality and good health. BRETT KRZYKOWSKI
Process improvement as part of a physical health and fitness plan works Manuscript Coordinator
similarly to how those same concepts and tools are applied in business. VALERIE FUNK

Setting SMART (specific, measurable, attainable, realistic and timely) Editor at Large
SUSAN E. DANIELS
goals, measuring progress, modifying inputs and
Contributing Editor
tweaking processes all help lead to the desired re- NICOLE ADRIAN
sults—dropping 15 pounds or finishing a 10K race, Copy Editors
for example. SUSAN GRONEMUS
KELLY SULLIVAN
Implementing good behaviors before problems
crop up is a vital component of good health. Jean Art Director
MARY UTTECH
Harvey’s article, titled “Exercise a Process
Graphic Designer
Improvement Approach for Your Own Personal SANDY WYSS
Wellness,” (p. 18) includes a sidebar in which the Production
CATHY SCHNACKENBERG
author describes diabetes as a complex process control problem (CPCP).
And, like with any CPCP, steps can be taken to prevent unwanted out- Advertising Production
BARBARA MITROVIC
comes—in this case symptoms, or worse.
Digital Production Specialists
So, suppose you reach your fitness goal. In fact, you’ve lost 20 pounds. ERIC BERNA, LAURA FRANCESCHI

Now what? Once you make healthy lifestyle changes, your focus needs to
shift to maintenance. Another QP article can help with that. Turn to p. 25 Account Executives
ANGELA M. MITCHELL
for “Eight Steps to Maintain Change,” by John R. Schultz. He details an MITCHELL PEZANOSKI
eight-step action plan for implementing and sustaining change. Classified/Recruitment Advertising
We all know how difficult it can be to muster the will, energy and ambi- RAMONA GARCIA

tion needed to exercise and eat well. Quality professionals are one step Marketing Administrator
ahead—you possess the tools and knowledge to plan the activities and MATT MEINHOLZ

manage the processes that produce the intended results. Editorial and Advertising Offices
414-272-8575 fax 414-272-1734
The author of the cover story also includes a handy “Getting Started”
ASQ ADMINISTRATION
plan in his article. And, looking forward to the deleterious effects of
Executive Director
Thanksgiving pumpkin pie and other holiday goodies on your usually PAUL E. BORAWSKI

(right?) healthful personal processes (and waistline), there’s no time like Managing Directors
CHRISTOPHER D. BAUMAN
the present to take the author’s advice—and run with it.
BRIAN J. LEHOUILLIER
MICHELLE MASON
LAUREL NELSON-ROWE

To promote discussion of issues in the field of quality and ensure

coverage of all responsible points of view, Quality Progress pub-
lishes articles representing conflicting and minority views.
Opinions expressed are those of the authors and not necessarily
of ASQ or Quality Progress. Use of the ASQ logo in advertisements
Seiche Sanders does not necessarily constitute endorsement of that particular
product or service by ASQ.
Editor

6 I NOVEMBER 2007 I www.asq.org

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 QP
MAILBAG
Quality vs. Quantity
I just finished reading the article
“Qualitative Indications From
Quantitative Instruments” by Graeme
C. Payne (September 2007, p. 76).
The first mistake I noticed in the arti-
cle was in the schematic symbol. In the
old days, “+” would be on the cathode,
not the anode. This made sense in
power supply rectification circuits but
was misleading, so the convention for
a diode schematic representation today
does not use any polarizing symbols.
In the article, Mr. Payne also
describes the forward voltage drop
measurement of a diode as a qualita-
tive measurement. I disagree with this
statement. It is a quantitative measure-
ment, as it is frequently used to mea-
sure forward voltage drops of silicon
diodes (approx 0.7V) or Shottkey
diodes (approx 0.2V). If the voltage
compliance of the current source is
high enough, the zener voltage of low
voltage zeners can also be measured.
I agree that full characterization of a
diode with a curve tracer (not an oscil-
loscope and current source) is the best
method. As with many types of com-
ponent test instruments, some instru-
ments can provide basic quantitative
measurements while others can pro-
vide more exhaustive quantitative
measurements. Our choice in instru-
ment is determined by the application.
BRUCE PETERSON
Accolade Engineering Solutions
Irvine, CA
Author’s Response
Mr. Peterson is correct to say the sym-
bol for a diode does not have polarity
symbols. In technical and engineering
Mr. Pareto Head
8 I NOVEMBER 2007 I www.asq.org
literature, it would not be appropriate
because the audience is expected to
know and understand the symbol.
However, the level of technical elec-
tronics knowledge among the Quality
Progress audience is unknown. Thus,
the placement of the polarity symbols
with the negative symbol at the cath-
ode end, where the bar of the symbol
represents the n-doped material and
electron flow enters the device.
Mr. Peterson is also correct that the
voltage drop across a diode junction is
a crucial parameter. This is particularly
true in an engineering context. A study
of the device’s current-voltage (I-V)
characteristic curve is an excellent visu-
al method for learning how it works.
However, that part of the column
addressed the practical aspects of testing
a diode in a service shop or field repair
environment. There, a technician is gen-
erally using portable instruments, with
an emphasis on economy and produc-
tivity. A trained technician can distin-
guish types of diodes from the reading
on the meter, but their primary empha-
sis is on the quality attributes of good
versus bad by using a “diode test” func-
tion on a digital multimeter (DMM).
For that indication (a voltage) to be
quantitative, the output of the current
source must be known and well regulat-
ed. On a typical DMM, the current
source output in the diode test function
rarely is included in the performance
specifications, and the function rarely is
calibrated. Since the source current is
unknown, there is no fast and easy way
to relate the DMM reading to the diode’s
I-V curve beyond “conducting” or “not
conducting.” There are assumptions that
can be made, but assumptions should
not be the sole basis of quality decisions.
GRAEME C. PAYNE
by Mike Crossen
CHAIR OF THE BOARD
Ronald D. Atkinson, General Motors
PRESIDENT
Michael D. Nichols, Nichols Quality Associates
PRESIDENT-ELECT
Roberto M. Saco, Aporia Advisors
TREASURER
E. David Spong, Boeing (retired)
PARLIAMENTARIAN
James J. Rooney Jr., ABS Consulting
DIRECTORS
Jochen Amelsberg, Juran Institute
Belinda Chavez, United Space Alliance
Brenda M. Fisk, Software Quality Solutions
Richard A. Gould, RG Management Solutions
Kamla P. Gupta, Continuous Improvement Technology
Stephen K. Hacker, Transformation Systems International
Gary L. Johnson, U.S. Environmental Protection Agency
Kay A. Kendall, Sun Microsystems
William H. LaFollette, Humana Inc.
Lou Ann Lathrop, General Motors
David B. Levy, Levy Quality Consulting
Richard A. Litts, Litts Quality Technologies
Richard F. McKeever, D2 Quality Associates
Aimee H. Siegler, Benchmark Electronics
Donald C. Singer, GlaxoSmithKline
Steven E. Wilson, U.S. Department of Commerce
Seafood Inspection Program
QP EDITORIAL REVIEW BOARD
Randy Brull, chair
Administrative Committee
Roger Berger, Brady Boggs, Randy Brull, Jane
Campanizzi, Larry Haugh, Jim Jaquess, Gary MacLean,
Christine Robinson, Richard Stump
Technical reviewers
I. Elaine Allen, Andy Barnett, David Bonyuet, John
Brown, Bernie Carpenter, Ken Cogan, Linda Cubalchini-
Travis, Ahmad Elshennawy, Tim Folkerts, Eric Furness,
Mark Gavoor, Kunita Gear, Lynne Hare, Ron Kenett, Ray
Klotz, Tom Kubiak, William LaFollette, Shin Ta Liu,
Pradip Mehta, Gene Placzkowski, Paul Plsek, Tony
Polito, Peter Pylipow, Philip Ramsey, R. Dan Reid,
Wayne Reynolds, John Richards, James Rooney, Anil
Sengupta, Sunil Thawani, Joe Tunner, John Vaks, Manu
Vora, Jack Westfall, James Zurn
BALDRIGE EXAMINERS WANTED

The Malcolm Baldrige National Quality Award, the nation’s premier

recognition for performance excellence, is seeking experts in the business,
nonprofit,
education, and
health care
sectors to
volunteer on
the 2008 Board
of Examiners.

As a Baldrige Examiner you will

• learn how leading organizations achieve performance excellence
• network with some of the nation’s foremost quality professionals
• use your expertise to improve America’s competitive position

See what it’s all about!

For more information,
visit www.baldrige.nist.gov/Examiners/qp.htm,
call us at (301) 975-2036, or e-mail nqp@nist.gov.

Online Examiner Application Available November 2007

KEEPING
CURRENT
STANDARDS

ISO/Microsoft Standard
Document Format Defeated
Microsoft’s request to have its proprietary document posal will fail, and the fast-track procedure will be termi-
format, Office Open XML (OOXML), become an interna- nated. Microsoft could lose revenue from the profitable
tional standard was soundly defeated when put to vote government market if OOXML is rejected next year,
in early September. according to a PC World article, because some govern-
ISO/IEC Draft International Standard (DIS) 29500, ments have mandated the use of document formats that
Information Technology—Office Open XML File comply with open international standards.
Formats, failed on two accounts required by the voting According to an ISO press release, Microsoft proposed a
process. Approval requires at least 66.66% of the votes standard for word processing documents, presentations and
cast by national bodies participating in International spreadsheets that is intended to be implemented by multi-
Organization for Standardization (ISO)/International ple applications on many platforms. One of the objectives of
Electrotechnical Commission (IEC) Joint Technical achieving the standard is to ensure long-term preservation
Committee (JTC) 1—ISO/IEC DIS 29500 received 53%. of documents that were created using programs that are
Additionally, no more than 25% of the total number of becoming incompatible with new IT programs.
the national body votes can cast negative votes. For this According to Microsoft’s website, the company’s
proposal, 26% of the OOXML is part of Microsoft Office 2007, which makes
votes were negative. sharing data more efficient and guarantees IT profes-
The five-month ballot sionals high standards of interoperability.
process for the draft The relevant subcommittee of ISO/IEC JTC 1 will meet
standard was open to in February 2008 for a ballot resolution meeting, where
the ISO and IEC they will review the comments from the votes and seek
national member agreement on possible changes. The standard could pro-
bodies. ceed into publication if the proposed modifications are
If the votes are not such that national bodies wish to withdraw their nega-
NO overturned, the pro- tive votes at that time.

ASQ

World Conference
Speakers Announced
The astronaut who played a key role in the return of the Apollo 13 astronauts from
the near-disastrous lunar mission in 1970 will be a featured speaker at ASQ’s 2008
World Conference on Quality and Improvement.
In his keynote address, T.K. “Ken” Mattingly will share his experiences in terms of
teamwork and leadership. Mattingly, who retired as a U.S. Navy rear admiral in 1989, Mattingly
was also a member of the space shuttle development team and the commander of two
shuttle missions. He is currently the president of the Rocket Development Co., which develops
commercial rockets for space transportation.
Gregory S. Babe, the president and CEO of Bayer Corp. MaterialScience, will also speak at the world
conference. Babe has held several management positions with Bayer since 1980, including vice president
of corporate quality.
For conference updates, go to http://wcqi.asq.org.

10 I NOVEMBER 2007 I www.asq.org

ASQ
QP Print, Online Redesigns
To Launch in January
This January, Quality Progress readers won’t just be turn-
ing the page of their calendars; they’ll turn a page on anoth-
er chapter in Quality Progress’ design history.
The redesigned Quality Progress will feature a clean, mod-
ern look and design features to enhance readability and con-
tribute to readers’ overall experience with the magazine.
“The new design is the culmination of extensive research
into what readers expect from media today,” says Seiche
Sanders, editor of the 40-year-old flagship publication of ASQ.
“People are bombarded with so much information on a daily
basis that the way information is presented becomes almost as
important as the content itself. This new presentation of QP
content addresses our need to remain competitive given read-
ers’ limited time.”
In preparation for the redesign, the voice of the customer
was captured in a number of ways, from surveys to focus
groups to phone interviews.
“What our research showed was how much readers trust
and value QP content, including the peer reviewed articles,”
Sanders says. “One request we heard over and over, however,
was the need for real-world answers to your specific quality
questions or challenges. This resulted in the development of a
new department called ‘Expert Answers,’ which gives readers
the expert advice they seek in a Q&A format.” The depart-
ment will debut in January.
The 2006 readership study also revealed readers’ desire to
be able to search for and browse QP contents topically. This
request was addressed with the redesigned QP website,
Sanders says, which will also launch in January and will fea-
ture a new URL, www.qualityprogress.com.
“The new functionality of www.qualityprogress.com
addresses this need perfectly. Users will be able to browse
by topic, sort, store and send articles quickly and easily,”
she explains.
The redesigned website will also include web-only con-
tent, daily news headlines, and new tools and interactive
features.
“The Quality Progress staff is excited to be able to bring
these changes to our readers,” Sanders says. “I believe they
demonstrate our deep commitment to enhancing our readers’
experience while providing them the valuable tools they need
to excel and succeed in their careers.”
W h o ’s
Name: David Steinberg
Q
Residence: Tel Aviv, Israel
Who in
Education: Doctorate in statistics from the University of
Wisconsin-Madison, 1983.
Current job: Professor of statistics at Tel Aviv University.
Previous jobs: I have spent my entire
career in academics, first as a student at
UW-Madison, then with post-doctoral
work at Stanford University and as a fac-
ulty member at Tel Aviv University for
more than 20 years.
Introduction to quality: While a student
in the department of statistics at UW-
Madison, I became familiar with quality. In particular, the
work of William G. Hunter attracted me to this area.
ASQ activities: I am the editor-elect of Technometrics, a
leading journal on statistical methodology in the engineer-
ing, physical and information sciences. Technometrics is a
joint venture of ASQ and the American Statistical Assn.
Other activities/achievements: One of the things I like best
about statistics is that I’m able to contribute to research in a
wide variety of disciplines. In addition to working with
industrial colleagues, mostly on the design of experiments,
I have collaborated on many medical research projects and
have been involved in research on implementation of the
Comprehensive Nuclear Test Ban Treaty.
Published works: I have published about 70 research
articles.
Recent honor: My paper with Dror Hovav, a recent doc-
toral graduate, was presented at the Technometrics session
at a spring research conference in May.
Personal: Married, three daughters.
Favorite ways to relax: Bicycling, listening to classical
music and jazz.
Quality quote: Quality is most obviously measured down-
stream, when products or services reach their customers. So
we are often led to focus on downstream activities related
to quality: trouble-shooting problems or weeding out
defective products. But the most important determinants of
quality are usually upstream, when the processes that gen-
erate products and services are defined. There is great
reward in moving quality improvement efforts to those
upstream stages and designing quality into the processes.
QUALITY PROGRESS I NOVEMBER 2007 I 11
KEEPING
CURRENT

ASQ

Thirty-Eight Teams Enter

Excellence Competition
The Team and Workplace Excellence Forum has announced
that 38 teams have entered the 2008 International Team
Excellence Competition:
• ALCOA, Newburgh, IN
• Allegheny Energy Inc., Greensburg, PA
• Baxter Productos Medicos Ltd., Cartago, Costa Rica
• Bayer MaterialScience LLC, Pittsburgh (two teams)
• Boeing Co., Long Beach, CA (four teams)
• City of Miami Beach, FL
• CSX, Jacksonville, FL
• Delphi Electronics & Safety, Kokomo, IN
• DENSO Manufacturing Tennessee Inc.,
Maryville, TN
• FRCSE Mayport, Mayport, FL
• Healthways, Nashville, TN
• Housing & Development Board, Singapore (three entries)
• Kaiser Permanente, Denver (two teams)
• Lockheed Martin Aeronautics, Fort Worth, TX
• Medrad Inc., Warrendale, PA
• Naval Surface Warfare Center Crane Division,
Crane, IN (two teams)
• New Breed, Swedesboro, NJ
• PricewaterhouseCoopers, New York
• Prodapt, Chennai, Tamilnadu, India
• R. L. Polk & Co., Southfield, MI
• Sanden International, Wylie, TX (two teams)
• Sterlite Industries India Ltd., Silvassa, Dadra and
Nagar Haveli, India
• Sterlite Industries India Ltd., Tuticorin, Tamil Nadu,
India (two teams)
• Stoller, Grand Junction, CO
• Tobyhanna Army Depot, Tobyhanna, PA
• U.S. Naval Ship Repair Facility and Japan Regional
Maintenance Center, Yokosuka, Japan
• U.S. Naval Ship Repair Facility and Japan
RegionalMaintenance Center Detachment, Sasebo,
jJapan
Judging of the preliminary round entrants at seven sites
across the United States ends Nov. 9.
The final competition will take place during ASQ’s
World Conference on Quality and Improvement, May 5-7,
in Houston.

ASQ

Women in Quality
Network Established
A recently created ASQ network geared toward women in the
quality profession has attracted more than 330 members.
The ASQ Women in Quality Network was formed in early
September to offer a forum for women to discuss jobs, careers and
gender based issues in the workplace, such as work-life balance. The
enthusiastic response from members reflects the largest participation
during the launch of a network since ASQ started its network program.
The women’s network plans to offer connections to discussion boards
and articles. The network will partner with the Leadership Institute—
Women with Purpose Inc., for content in some areas. For more informa-
tion about the women’s network and registration details, visit
www.asq.org/communities/women-in-quality/index.html.

12 I NOVEMBER 2007 I www.asq.org

HEALTHCARE

Hospital
Deficiencies
Persist, Recent
Report Says HEALTHCARE

Eighty-seven percent of U.S. hospitals do not

take recommended steps to prevent avoidable
infections, according to a recent survey by the
Leapfrog Group.
Over half of the responding hospitals indicated
they have adopted the Leapfrog Never Events poli-
cy, a list of actions hospitals pledge to take when
rare medical errors occur that were preventable.
Conversely, the Leapfrog Group has recognized
41 hospitals for their quality and safety best prac-
tices, based on the results from another recent sur-
vey conducted by the organization.
Leapfrog asked 1,285 hospitals to respond to a
quality and safety survey and rated the hospitals in
four areas: computerized physician order entry,
intensive care unit physician staffing, evidence
based hospital referral and other safe practices.
The Leapfrog Group is a coalition of corpora-
tions and public agencies to improve patient safety.
For more information on the survey results, visit
www.leapfroggroup.org/news.
Study
Highlights
Pharmaceutical, Medical
Device Quality Practices
A study by Best Practices LLC shows best-in-class pharmaceuti-
cal and medical device companies have a ratio of quality person-
nel to total manufacturing employees between 1:4 and 1:7.
The report, “The Quality Function: Structure, Staffing and
Execution,” uncovers best practices in quality taken from survey
responses and interviews with seven top pharmaceutical and
medical device company leaders, including Abbott, Johnson &
Johnson and GlaxoSmithKline. Best Practices LLC examined the
systems, approaches and practices of the companies and com-
pared their structure, staffing, roles and responsibilities of the
quality function.
A report excerpt is available at www3.best-in-class.com/rr851.htm.

ASQ News
ADVISORY COUNCIL
FORMED The ASQ Public Policy
Advisory Council has been formed
to counsel the office of the president
and the board of directors on issues
facing ASQ. Two existing groups—
the Issue Action Committee and the
Washington Presence—have been
combined to form the new advisory
council. Kay Kendall, ASQ board
member, chairs the new council.
SOCIETY CO-HOSTS NON-
PROFIT FORUM To expose more
nonprofit organizations and associa-
tions to quality, ASQ recently
partnered with the American Society
of Association Executives’ Center for
Association Leadership and the
Association Forum of Chicagoland
to host the first Nonprofit Quality
Forum. Retired Boeing CEO E. David
Spong, who led two Boeing divi-
sions to Malcolm Baldrige National
Quality Awards, was the featured
speaker at the daylong event.
CGW GRANT AWARDED ASQ
has awarded a $15,000 Community
Good Works grant to the Partnership
for Education in Ashtabula County
(PEAC) in Ohio. PEAC plans to use
the grant to enhance its outreach
program and engage more parents
and families on different issues
related to the quality of education
in the five school districts it covers.
PACT FORMED WITH THAI-
LAND ASQ has agreed to offer
its body of knowledge to small and
mid-sized enterprises in Thailand
through Thailand’s Department of
Industrial Promotion. Gary
Bargenquast, ASQ’s country coun-
cilor in Thailand, spoke at an event
marking the signing of the agree-
ment.

QUALITY PROGRESS I NOVEMBER 2007 I 13

KEEPING
CURRENT

short
runs close at the end of 2007. To order, call
800-248-1946 or 414-272-1946, or go
to www.asq.org/quality-press/
display-item/index.html?item=T852E
(case sensitive) and ask for item
tutes, including the American
National Standards Institute at
www.ansi.org, and ISO at
www.ISO.org.

DRAFT INTERNATIONAL T852e. THE SUPPLY-CHAIN COUNCIL

STANDARD ISO/Draft International
Standard (DIS) 9001 Quality
Management Systems—Requirements
is now available for purchase from
ASQ. No new requirements are
being added to ISO 9001 during this
revision. Instead, the emphasis is on
clarifying language. The period for
submission of public comments will
A NEW FOOD SAFETY STAN-
DARD has been released by the
International Organization for
Standardization (ISO). ISO 7218:2008
provides requirements and guidance
for microbiological examinations of
food and animal feed. It is available
from ISO’s national member insti-
recently debuted a members only
benchmarking portal based on the
Supply Chain Reference Model. The
portal provides global benchmark-
ing insights for setting performance
goals, calculating performance
gaps and developing company spe-
cific roadmaps. For more informa-
tion, go to www.supply-chain.org.

Web Watch
This month’s Web Watch focuses on process improvement.
For more quality related websites, visit www.asq.org/links.

www.ispi.org social service sector. The comprehensive resources

The International Society for Performance
Improvement (ISPI) is an international association
dedicated to improving productivity and perfor-
mance in the workplace. The website offers informa-
tion about the organization’s mission, educational
opportunities, members and conferences. The ISPI’s
free electronic newsletter can also be downloaded.
deming.eng.clemson.edu
The Continuous Quality Improvement Server
includes the Deming electronic network, community
quality electronic network and public sector net-
work, all of which support quality improvement and
education in quality. Maintained by the Clemson
University Department of Industrial Engineering,
most files in this server are free to download.
include information on meeting accreditation stan-
dards, developing teams, improving processes and
measuring outcomes. Other features include discus-
sion groups and a calendar.
www.quality-control-plan.com/spc-definitions.htm
This site leads you to a range of statistical process
control definitions from 3 sigma to zones. You will
find more quality information under the Free Guides
drop down menu. There are links to other websites
and opportunities to buy quality related documents.
More websites. Links to and descriptions of these
sites and past Web Watch sites can be found in the
cumulative Web Watch listing online. Click on the
Quality Progress link at www.asq.org.

www.loebigink.com/qnet Found an interesting quality site? If you

Lutheran Children and Family Services of Eastern come across a noncommercial site that
Pennsylvania’s comprehensive site is for quality could be useful to other quality profes-
improvement professionals in the public and private sionals, e-mail it to medmund@asq.org.

14 I NOVEMBER 2007 I www.asq.org

 NEW SIDE IMPACT SAFETY
REQUIREMENTS for all vehicles
STANDARDS
were recently developed by the
National Highway Traffic Safety
Administration. For the first time, Voting Standards
the standard requires auto manufac-
turers to provide head protection in
Guidance Sent
side impact crashes. To view the
new rule, go to www.nhtsa.gov/
To Election
staticfiles//DOT/NHTSA/Rulemaking/
Rules/Associated%20Files/214_Side_
Commission
Impact_final_Aug_30_2007.pdf (case
Recommendations for a new set
sensitive).
of requirements intended to make
future voting systems more secure,
THE AMERICAN NATIONAL
reliable and easier for all voters to
STANDARDS INSTITUTE has
use have been submitted by an
agreed to strengthen standards
advisory panel to the Election
collaboration with the national stan-
Assistance Commission (EAC).
dards bodies of Brazil, Saudi Arabia
The recommendations are a rewrite of similar guidelines issued in 2005
and Thailand. The goal is to achieve
by the advisory Technical Guidelines Development Committee, which is
common objectives and encourage
chaired by the director of the National Institute of Standards and
international trade. For more details,
Technology (NIST), with technical support provided by NIST staff.
go to http://web.ansi.org/news_
Key recommendations include guidelines that:
publications/latest_headlines.aspx?
• Allow auditing of voting system records independent from the voting
menuid=7.
system’s software.
• Allow each voter to verify the accuracy of a vote before leaving the
THE OFFICE OF THE U.S.
polling station.
TRADE REPRESENTATIVE is
• Improve voting system reliability and reduce problems with machine
seeking comments regarding
failure on election days.
instances in which standards, certifi-
• Tighten security measures through digital signatures and other
cations or self-declarations of con-
means to protect voting system software against unauthorized alter-
formance issues have been barriers
ations.
to trade. Comments are due no later
• Ensure voting systems are relatively easy to use accurately, based on the
than Nov. 9. They can be e-mailed to
results of laboratory tests in which participants vote in mock elections.
FR0717@ustr.eop.gov or faxed to
EAC is expected to conduct public reviews of the recommendations
Gloria Blue at 202-395-6143.
before issuing a final version, most likely in 2009. For more information, go
to www.nist.gov/public_affairs/techbeat/tb2007_0913.htm#tgdc.
THE ANSI-ASQ NATIONAL
ACCREDITATION BOARD (ANAB)
has acquired Assured Calibration
and Laboratory Select Services LLC, Commission, an accreditor of health enrolled in 767 health plans improved
expanding ANAB’s range of confor- care management organizations, spent in 2006, but the gains were smaller
mity assessment services to include more than a year developing the stan- than in past years, according to a new
accreditation of testing and calibra- dard and testing for the program. For report by the National Committee for
tion laboratories. For more informa- more information on the accreditation Quality Assurance (NCQA). NCQA is a
tion, go to www.anab.org. for this specialty health service, visit nonprofit that accredits and certifies a
www.urac.org/press/cmsDocument. wide range of healthcare organizations
A NEW ACCREDITATION aspx?id=526. and recognizes physicians in key clini-
PROGRAM for drug therapy manage- cal areas. “The State of Health Care
ment services has been unveiled. THE QUALITY OF HEALTHCARE Quality 2007” report is available at no
The Utilization Review Accreditation for more than 80 million Americans cost at www.ncqa.org. QP

QUALITY PROGRESS I NOVEMBER 2007 I 15

PROCESS IMPROVEMENT
Exercise a Process
Improvement
Approach for Your
Own Wellness
T
urning 40 can be a wake-up call for some-
one who has not seriously invested in per-
sonal wellness.
After all, “wellness is a positive, day-to-day
approach to a long, healthful and active life. One
crucial tenet is that preventing illness is even more
important than treating it, especially since many
chronic diseases are incurable.”1
This should ring a bell for quality practitioners:
In 50 Words
Or Less
• The human body can be viewed as a system of processes
in which the output of one process is an input to another.
• One quality practitioner applied the concepts of systems
thinking, process thinking and process management to
improve his own health, prevent future ailments and
maintain a healthy lifestyle.
18 I NOVEMBER 2007 I www.asq.org
by Jean Harvey
An ounce of prevention is worth a pound of cure in
our field as well.
Is there anything more important than putting the
tools of our trade and our passion for quality to good
use? If we can contribute to organizational wellness
with these tools and passion, why shouldn’t we be
able to take care of ourselves in the same way?
Achieving a healthy lifestyle—and maintaining
it—is reason enough to explore new ways to lever-
age well-honed professional skills to improve your
own quality of life.
First, we must show how systems thinking is
essential to understanding personal processes.
Then we need to realize the applicability of statistical
thinking in this context before turning to evidence
based process management. Finally, we must con-
sider how to scope improvement projects and
improve personal processes.
Systems and Process Thinking
Quality practitioners understand that an organi-
zation is a system of processes in which the output
of one process is input to another. It’s not a stretch
to say that the human body is such a system (see
“Diabetes as a Complex Process Control Problem,”
p. 21). Figure 1 depicts one possible FIGURE 1 Simplified Systemic Vision of Body and Mind System
representation of a person’s processes.
Eating and drinking (process one Food, A. Energy Personal
3. Lead professional life
and two of the system) requires food, drinks, satisfaction
1. Eat 2. Drink
drinks and productive time as inputs. time Professional
4. Lead personal life
and energy satisfaction
It produces energy and has a health
impact. The latter affects our stock of B. Productive
health and fitness (process C), which time
increases our supply of productive
time (process B). We can draw on this C. Health and
as needed to lead our personal and Health and fitness
professional lives (processes three and fitness impact
four), work out (process five), eat 5. Work out
(process one), sleep (process six) or
any other pursuit. 6. Sleep
High level processes, such as “lead Selected health Health and Legend
7. Treat ailments Transformation
professional life” (process three), con- related processes fitness impact
sist of many lower level processes, such 8. Perform leisure activities Input Output

as “visit supplier” or “plan ISO 9001 9. Monitor and improve health

audit” (both not shown in Figure 1).
These processes work as a system
because changes in one process can
have systemwide impacts through positive and neg-
ative feedback loops.
While each person’s life goals vary, let’s assume
the goal is to maximize personal and professional
satisfaction. Health and fitness (process C) are criti-
cal means to that end.
Statistical Thinking
As changes occur in process variables, the out-
put of any repetitive process varies. Some changes
are significant and provide important clues to how
the process works. Other changes are not impor-
tant and can be misleading.
Thus, rigorously measuring and analyzing varia-
tion is essential to understanding a process and
improving it. Statistical thinking is the reflex we
develop to interpret variation data in probabilistic
terms. Without statistical thinking, it is easy to
jump to conclusions, resulting in endless tinkering
with the process.
One quality professional working for 3M used
statistical thinking to help his spouse control her
diabetic condition2—a challenging process control
problem.
This person’s husband measured variation in the
glucose level and correlated it with variables that
are known to affect it. Variables were both control-
lable and uncontrollable, such as different foods,
Stock
exercise, illness, infections and especially emotion-
al stress. From there, he was able to gain a much
better understanding of factors affecting his wife’s
glucose level.
As a result, the wife was able to exert more con-
trol of her condition. This resulted in less testing,
less insulin, better health and a better quality of
life. Achieving such results is possible only when
you take a rigorous, active and take-charge
approach to your own health.
“The real value of control charts and statistical
thinking is to help us learn about our processes,”
the husband wrote. “Failure to introduce the charts
essentially guarantees that one will continue to be
ignorant of how to control the process.”3
Managing Health
Information—Rigorously
Information is power, and health information is
power over your health. This applies first to gener-
ic health information, such as what’s likely to keep
you healthy and what’s likely to cure illness.
Just as in business, finding the right information
is done through mining data (only it’s health relat-
ed) and extracting useful information from it.
Because missing important new health facts (for
example, news that a medication you have been
taking has unforeseen side effects) can be detrimen-

QUALITY PROGRESS I NOVEMBER 2007 I 19

PROCESS IMPROVEMENT

tal, the personal process that addresses this step
(process nine in Figure 1) is critical. Unfortunately,
few people go about this systematically.
Consider the following example: In 2005, a study
published in a reputable medical journal conclud-
ed that being a little overweight was associated
with a somewhat lower death rate.4 This prompted
a New York Times editorial writer to jump to conclu-
sions, dismissing decades of medical research. “For
those of us lacking six-pack abs, this week’s report
that the overweight live longer is the greatest med-
ical news in history.”5
The study was conducted by the U.S. Centers for
Disease Control and was based on epidemiological
data spanning about 30 years. Extracting useful
information from such data points requires asking

Getting Started
There isn’t one correct way to start paying attention to personal wellness. If you never have, though, there is a
rule of thumb about when to get started: the sooner, the better.
Here is one way to get started.
1. Set high level, realistic, personal goals (for example, “the Big Y’s” in Six Sigma that refer to business results
that matter). Decide how you are going to monitor progress toward these goals.
2. Try to view your activities as processes with discrete starting and ending points. Use action verbs to name them.
3. Draw a simple process model, such as the one shown in Figure 1 (p. 19). There is no right answer. We are all
different. Try it. There will be holes and incoherence. Let it be.
4. Design a systematic process for monitoring health news. Keep it simple at first. Make sure it is not excessive-
ly time consuming and fits well in your schedule. Get into the habit of going beyond headlines and exploring the
source and validity of the data. When a piece of information draws your attention, look for other sources.
Gradually decide what sources you should trust. Build a watch list of health news that
you consider relevant (RSS feeds provide a convenient way for doing this).
5. Formulate a specific, measurable, achievable, relevant and timely
(SMART) goal when a major worrying fact emerges, which highlights an
important gap between the way you do things and what is required to get
closer to your goal. Do not go for the home run. Make sure the first project is
a success, and future wins will certainly follow.
6. Look at your process map and identify the most important culprit or
leverage point. Refine your process model as you do so.
7. Rigorously and simply start measuring the performance of the process.
Use variation as a guide to learn about processes. Think statistically. A spreadsheet
or your favorite statistical process control software will come in handy.
8. Pick one or two simple tools from the process improvement toolkit, such as process mapping, failure mode
effects analysis or value added analysis. Use tools that are best suited for the job and get to work on process
improvement.
When the process is fixed and the goal achieved, think back on the lessons learned about your improvement
process. This is called double-loop learning: If every time you improve a process (single-loop learning) you find a
way to do it better the next time (double-loop learning), and you will soon excel at it. Capture the lessons you
learned on a spreadsheet and revisit them every time you embark on a new project. –J.H.

20 I NOVEMBER 2007 I www.asq.org

questions quality practitioners are quite familiar
with, such as:
• Was the measurement system valid? Maybe
not. The body mass index (BMI) used in the
study is not a good indicator of body fat in
elderly people. Being lean for an adult might
mean being muscular. It probably means
being frail for an elderly person, as we lose
muscle over the years. The ratio of one’s
waist to one’s hips would have been a better
indicator of body fat in the elderly, but that is
also more difficult to measure correctly.
• Could the correlation be spurious? For exam-
ple, could smokers and people who are ill—
two factors often associated with a shorter
lifespan—also be leaner than others? Is their
number large enough to explain the observed
correlation?
• What is the underlying rationale that would
explain this study’s conclusion? The study’s
results fly in the face of everything known in
health sciences today, prompting an expert to
ask, “What yet to be discovered factor is so
powerful that it not only counteracts the
higher risks of diabetes, cardiovascular dis-
ease and cancer in the overweights, but also
makes being overweight beneficial?” No one
could provide a satisfactory answer.6
Based on the credibility of its authors and the
general soundness of the method the study is too
serious to be brushed aside. A rigorous person con-
cerned about weight gain might pay some atten-
tion to this study and save it for future reference.
However, based on the earlier discussion, he or
she would mark the study as doubtful and not
take any immediate action.
Information on your own state of health (for
example, regular test results such as cholesterol
level) is also vital. Ongoing measurement of other
important health parameters, such as blood pres-
sure, weight and waistline can be interpreted
using appropriate statistical process control (SPC)
charts and can allow for early detection of signifi-
cant changes, prompting us to search for a root
cause and the appropriate corrective action.
Doing the Right Thing: Scoping
Personal Improvement Projects
Economist John Maynard Keynes once report-
edly answered a journalist’s pointed question
with the quip: “When the facts change, I change
my mind. What do you do, sir?” 7
Once you conclude that the relevant facts as you
know them have changed, it is time to act. This
action must first be guided by a specific, measurable,
achievable, relevant and timely (SMART) statement
such as “I have a 38-inch waist; it should be 36. I’ll
reach this goal before I hit the beach next summer.”
The target relates to something important and is
well grounded in health evidence. The SMART
Diabetes as a
Complex Process
Control Problem
Our body is a system of processes. For instance, eating
involves taking food from one’s plate, processing it through
the hands, mouth and esophagus, and delivering masticat-
ed food to the stomach. The gastrointestinal tract takes this
as input, digests it and delivers various types of nutrients to
the blood.
For instance, blood transports glucose to various body sys-
tems that either store it or burn it as fuel, which in turn pro-
duces the energy the body needs. For the body to function
well, one’s glycemia level, or the quantity of glucose in blood,
must remain within a given tolerance.
For diabetics, maintaining and controlling this process is
a permanent challenge. The system produces feedback,
which they can use to assist in that pursuit. Excess sugar
produces symptoms such as blurred vision, fatigue and
weight loss. Lack of sugar produces different symptoms
such as heavy sweating, shakiness, headache and trouble
with speech.
Diabetics must learn to interpret these symptoms and
decide whether corrective action is required and when to
act. Injecting insulin increases the glucose output from the
blood into body cells, thereby reducing the glycemia level.
Drinking orange juice, on the other hand, quickly raises the
input of sugar into the blood. –J.H.
QUALITY PROGRESS I NOVEMBER 2007 I 21
PROCESS IMPROVEMENT
statement could provide an appropriate timeframe
and create a sense of urgency. Progression toward
the goal can be measured and help you learn what
works and what does not.
Then you must identify the process or processes
you must change to fix the problem. Processes such
as “eat dessert” (a subprocess within process one
in Figure 1, p. 19), “drink alcoholic beverages”
(part of process two) or “work out” (process five)
are all potential candidates based on what is
known about the effect they have on cholesterol
and waistline.
Of course, the choice depends on the current
functioning of these processes and an assessment
of the very personal and subjective level of effort
required to modify deeply rooted habits.
As you get into the habit of scoping8 and fixing
personal processes, Figure 1 can become more per-
sonalized, and the depiction of personal processes
can become increasingly specific and accurate. As
the contours of discrete processes emerge, what ini-
tially appears as a jumbled flow of loosely related
activities gradually shapes up.
Just as each business should evolve its own
process model, so should each individual. To make
sure yours is real and meaningful to you, start with
a simple representation and let the pattern of
processes emerge over time.
As you learn to recognize different processes
and deal with them as distinct units interacting
with each other, it is better to draw up an explicit
model. The drawing forces you to recognize inco-
herence and refine your understanding. As the res-
olution of your personal process model increases, it
becomes easier to pinpoint the right thing to do
when unsettling new wellness facts emerge.
Doing Things Right:
Making the Process Work
From a technical standpoint, this is probably the eas-
iest part of a quality professional’s drive toward well-
ness. Whichever is your favorite approach—the
Deming wheel (plan-do-check-act cycle or PDCA),
the Six Sigma improvement (define, measure, ana-
lyze, improve and control) and design (define, mea-
sure, analyze, design and verify) methods, lean
techniques, the Five S’s—it can be readily trans-
ferred to personal processes.
Depending on your situation and need, you can
22 I NOVEMBER 2007 I www.asq.org
decide to incrementally improve the way you eat or
innovate and go for radical change.9, 10 While the
personal context does not require the same degree
of formality as the business context, it does require
discipline as a core component.
This is particularly challenging to many people,
like some of the amusing and insightful characters
in Who Moved My Cheese?11 The sidebar, “From
Jogging to Walking—A Rundown” recounts a per-
sonal process change that took place over a six-
month period. It presents the basic change forces
required to overcome resistance: motivation, vision,
sense of urgency and means.
Another Quality Progress author once wrote how
he used a process based approach to switch from
driving a minivan to riding a bicycle to and from
work. He achieved health improvement while
securing financial gains.12 He flowcharted his
process in detail and used the PDCA cycle—chang-
ing his travel route and installing new bicycle
tires—to gradually close all performance gaps
between planned and actual output.
“If this Spartan, yet highly sophisticated, quality
management tool was so successful in helping me
improve my commute to work, perhaps it will bene-
fit others who desire to make improvements in their
business or daily lives as well,” the author wrote.13
Don’t Wait for a Catastrophe
Just as some organizations’ leaders think of quali-
ty approaches as a last resort before going under, all
too often dramatic health circumstances—such as a
heart attack or cancer—provide the motivation and
sense of urgency to make a change. Better late than
never, of course.
Quality leadership, however, requires the build-
ing and communication of a vision that pulls peo-
ple into action rather than waiting for catastrophic
events to push them into it. A vision of personal
excellence performs much the same service for
wellness. Since many diseases cannot be complete-
ly cured, prevention and staying proactive are cen-
tral tenets of personal wellness.
You are not only what you eat, but you are also
what you do. Choosing to see that through the
process improvement lens is a natural connection
for quality practitioners to make. They should not
only be among the most personally rigorous people,
they should also be advocates of personal rigor. It
From Jogging to
Walking—A Rundown
Facts: Why change? After 25 years of jogging an average of five hours each week, my knees were beginning
to hurt. Though I had been reading headlines about it, it was an orthopedist who finally got my attention.
“Another five years of this regimen and even walking will be painful,” the orthopedist told me.
Vision: Change for what? The front cover of Time magazine (“The Science of Staying Healthy”)1 several years
ago set me in motion, searching for a mental image of a different and attractive reality. Specifically, an article
titled “Walk, Don’t Run,” along with hard data and solid support, convinced me there were better and more sus-
tainable ways to reach my goals. I started to search for more informa-
tion—reading articles, talking with experts and comparing notes
(benchmarking) with friends and acquaintances.
Sense of urgency: When should I change? As I approached my 50th birth-
day and looked for ways to celebrate the event, I promised myself I would
never run again after that day. Commitments to yourself are very much a
part of what personal process management is about. That left me six
months to experiment with various alternative training strategies and make
sure I had a viable training program ready for “the day after.”
Means: How should I change? Now that I was motivated, held a vision
and felt the pressure to get started, all that was missing was a plan of
action and the means—the time, equipment and know-how—to get started. I found just enough information on
the web to answer questions like, “How do you do race walking?” and “What make and model of rollerblades
work best?” These were ingredients for the sport cocktail I envisioned.
Eventually, I experimented with many sports in various mixes and dosages. I ended up with an eclectic mix of
race walking, bicycling, stationary bicycling, swimming and walking on a treadmill with a 15% inclination. I set a
standard of one hour a day (which I can fraction as required), noted it in my daily agenda and transferred it to
process improvement software every month.
The new process is much more flexible and stimulating than the old one. Key health indicators (blood pressure,
weight and cholesterol) have not budged, which are important clues to the effectiveness of the program.
I discussed this with a business acquaintance, who responded that he intentionally refused to introduce any
sort of structure in his personal life as a reaction to what he felt was an overstructured professional life. I respect
that. I certainly keep many parts of my life spontaneous and intuitive as well.
However, systematically disregarding wellness knowledge and know-how comes at a price. Since personal
life choices are, well, personal, a reasonable person might decide to forego these benefits in exchange for
immediate freedom of care. It strikes me, however, that most people act out of blatant disregard for inconve-
nient truths. Quality practitioners, of all people, should not be included that number. –J.H.
REFERENCE

1. “The Science of Staying Healthy,” Time, health and medicine section, Jan. 21, 2002.

QUALITY PROGRESS I NOVEMBER 2007 I 23

Harvey-1107 10/22/07 1:02 PM Page 7
PROCESS IMPROVEMENT
can be fun and rewarding in a very personal way. It
can also transform a mere job into a lifelong passion.
REFERENCES
1. Berkley Wellness Newsletter, “What is Wellness?”
www.wellnessletter.com/html/wl/wlAbout.html.
2. Tom Pohlen, “Statistical Thinking: A Personal
Application,” ASQ’s Annual Quality Congress Proceedings, 1999,
pp. 230-236.
3. Ibid.
4. Katherine M. Flegal, Barry I. Graubard, David F.
Williamson and Mitchell H. Gail, “Excess Deaths Associated
With Underweight, Overweight and Obesity,” The Journal of
the American Medical Assn., Vol. 293, No. 15, 2005, pp. 1,861-
1,867.
5. John Tierney, “Fat and Happy,” The New York Times,
April 23, 2005.
6. Bonnie Liebman, “The Weight Debate,” Nutrition Action
Healthletter, Vol. 32, No. 8, October 2005.
7. Quotations by John Maynard Keynes, www-groups.
dcs.st-and.ac.uk/~history/Quotations/Keynes.html.
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24 I NOVEMBER 2007 I www.asq.org
8. Jean Harvey, “Scoping Improvement Projects in
Professional Services—A 10-Step Approach,” Quality Progress,
August 2004, pp. 64-72.
9. Jean Harvey, Managing Service Delivery Processes: Linking
Strategy to Operations, ASQ Quality Press, 2006.
10. Jean Harvey, “Switching from Improvement to Innovation
—On the Fly,” Quality Progress, January 2007, pp. 53-63.
11. Spencer Johnson and Kenneth Blanchard, Who Moved
My Cheese? Putnam Publishers, 2000.
12. J.M. La Lopa with R.F. Marecki, “Quality Management
Hit the Road,” Quality Progress, April 2000, pp. 59-64.
13. Ibid.
JEAN HARVEY is a professor at the
University of Quebec at Montreal. He
holds a doctorate in business from the
University of Western Ontario in
London, Ontario. Harvey is a member
of ASQ.
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Mfbo!Tjy!Tjhnb!Pomjof!Usbjojoh!'!Dpbdijoh
PROCESS IMPROVEMENT
Eight Steps
To Sustain Change
by John R. Schultz
I
mprovement projects, although well intentioned
and defined, often bog down in their latter stages
because team members and sponsors can lose
focus once a solution is found. Efforts naturally center
on the problem, measurement and analysis, and poten-
tial solutions, but they often fail to consider factors
affecting how improvements will be permanently inte-
grated into daily work.
Problem solving and improvement methods are nor-
mally accomplished in two phases: The first deals with
problem identification and solution finding and the
In 50 Words
Or Less
• Successful problem solving and improvement
require more than problem identification and the
discovery of a workable solution.
• The results need to become engrained in daily
work routines.
• Eight steps can eliminate resistance and secure
the improvements and changes.
second with implementing a corrective action.
These activities often operate under time con-
straints, with energy focused on the preliminary
stage as team members grapple with issues and
resolutions. Implementation then becomes a rush
in which thoughtfulness about people and process
impacts get shortchanged. This progression is char-
acterized in Table 1 (p. 26).
Once a solution is found, there is a temptation to
push new ideas on the system, only to find actions
foundering as participants come to grips with unfa-
miliar concepts. Largely out of frustration, the people
who manage and work in the system become grous-
ing skeptics, procrastinators and active resistors.
Even when the need is recognized and the solu-
tion is acknowledged as technically sound, work
activities may stubbornly continue as if nothing
new had been proposed. Getting people on board
and involved can be terribly frustrating and in-
crease the cost of transition.
Example of Poor Integration
The following case is based on a consulting
experience with a company implementing the
ISO 9001 quality management system:
A customer required compliance, but not reg-
istration. A documented system was in place, and
the president chaired an active steering committee.
Members were department heads, including the
QUALITY PROGRESS I NOVEMBER 2007 I 25
PROCESS IMPROVEMENT

quality manager, and the union president.
System upgrades were made using a seven-step
approach. Time was a factor because noncompliant
product had been reaching the customer despite
assurances protocols were being followed.
Much of the documentation had been written by
the quality manager and edited by the president.
Review by managers and supervisors, who were
asked to implement applicable elements in their
departments, was minimal.
Consequently, many of the procedures and instruc-
tions did not reflect work realities. They depicted an
ideal and were ultimately challenged as supervisors
and process operators tried to implement them. But,
since the clock was ticking and the customer was
threatening to cancel orders, implementation proceed-
ed with promises of revision once improvements were
in place.
Making the quality system operable was chaotic.
Managers, not wanting to appear unsure of their
changed responsibilities and authority, clung to the
status quo. Training—when done—focused on lower
level employees, which left supervisors without a
good understanding of new requirements. They were
caught saying one thing but doing another.
Interfaces between departments and individuals,
although described in an organizational chart and
statements of authority and responsibility, were not
truly functional. System workflow faltered because
new relationships and interdependencies encoun-
tered old departmental barriers. Audit reports and
corrective actions languished because the president
periodically overrode the quality manager’s authori-
ty, fearing delivery promises might be compromised.
Early implementation steps were handled well.
Gaps and shortfalls were identified, and proposed
solutions recommended. But, because of time, it
was assumed that acceptance and adoption would
be automatic.
Steering committee members rationalized that
everyone knew what needed to be done because
solution finding had been such a fervent effort.
However, like many improvement projects, con-
cluding steps were inadequately thought through
and poorly managed. Proposed solutions were not
completely integrated into daily activities.
The realization phase lacked a comprehensive plan
that would make system changes truly operational.
This created indecision at supervisory levels, inade-
quate coordination and dissatisfaction by those trying
to make changes workable. In time, due to frustra-
tion, the proposed improvements were resisted.
People tried to maintain a sense of order and get their
work done by falling back on customary routines.
Reasons for Resistance
Systems and processes exist in their current state
because someone got them to that level of refine-
ment. As flawed and inconsistent as they may now
appear, at some point in the past, an effort—possi-
bly heroic—was made to coordinate activities and
relationships to create a sense of order.
Then, over time, those involved learned to com-
pensate for gaps and made the system operational.
In turn, they built a mental model about who they
were and what they could do based on this config-
uration for getting work done.
Proposed improvements can threaten these men-
tal pictures and create self-doubt because the new
way for operating often requires unfamiliar skills
and social structures. Uncertainty then produces
anxious feelings about loss of identity, position and
face that give rise to guarded behavior.
These fears might take many forms—from nega-

TABLE 1 Typical Problem Solving and Improvement Model

Problem identification and solution finding
1. Identify and define the problem.
2. Describe and measure the process affected.
3. Identify and analyze causes.
4. Develop a solution that addresses causes.
Solution implementation and corrective action
5. Plan and implement process improvements.
6. Evaluate outcomes and make modifications if required.
7. Standardize and integrate into daily work.
Actions are often readily and enthusiastically accomplished. However:
• Finding a solution, not corrective action, becomes the goal.
• Energy is exhausted on solution finding.
• Problem solvers retire mentally once a solution is found.
Actions are often insufficiently thought through and hastily done
• Time becomes a factor and there is a rush to conclude the project.
• Impacts on people get shortchanged.
• Standardization and integration are incomplete.

26 I NOVEMBER 2007 I www.asq.org

tive attitudes to active sabotage—and manifest
through reduced productivity, decreased quality,
increased absenteeism and more grievances. The
sources for resistance are summarized in Table 2.
Dealing With Resistance
Fear and anxiety are natural responses to
change. They can be dealt with, but this requires an
atmosphere of openness in which people can speak
their minds and be heard.
The key to coping with resistance is to under-
stand the needs of people who are affected by
change and actively take steps to address their
issues. Resistance to a proposed improvement
should be a signal that something may have been
missed: Mistakes might have been made, concerns
not satisfactorily handled or a proposal inadequate-
ly presented and consequently misunderstood.
The choice of responses and techniques that might
be applied are multiple and somewhat dependent on
the personal perspective of the individual agent for
change and the challenges encountered. Whatever
the case, John Kotter and Leonard Schlesinger sug-
gest strategies for dealing with resistance to change.1
Any or all can be used depending on the situation.
• Education and communication. Used when
there is the assumption that information is
lacking, inaccurate or poorly analyzed.
• Participation and involvement. Ensures those
affected by the change have input into the
design and realization activities.
• Facilitation and support. Special attention is
paid to people’s needs and concerns through
team building, confidence building, training
and removal of barriers.
• Negotiation and compromise. Through a
process of negotiation, modifications are made
to the proposed change, or some form of com-
pensation is provided to reduce losses that
result from the change.
In addition, two more approaches can be used to
overcome and reduce resistance. These two
approaches deserve separate consideration since
they are coercive and top-down in nature and often
used as a last choice rather than a first alternative:
• Manipulation and co-optation. Involves
covertly managing and distorting information,
as well as systematically controlling resources,
rewards and key individuals through sub-
terfuge and deception.
TABLE 2 Sources of Resistance to Change
• Doubt about the causes and consequences of the proposed improvement:
There is uncertainty about the intention behind the change and how it will
impact existing work structures and relationships.
• Concern over the loss of existing benefits: There is fear about how potential
changes will impact power, prestige, salary, quality of work or other per-
ceived benefits attributed to the current system.
• Realization that the proposed improvement is flawed: There is awareness
that the new way of operating has problems that will create difficulties in the
current system or adjacent process.
Source: Paul R. Lawrence, “How to Deal With Resistance to Change,” Harvard
Business Review, January-February 1969, p. 47.
• Explicit and implicit coercion. Blatantly uses
power with the threat of adverse conse-
quences and punishment to force compliance
with the proposed objectives.
When these approaches are used, continuing
relations between levels of authority can become
adversarial because they produce compliance
rather than buy-in.
Any time there are alterations to established rou-
tines, no matter how inconsequential, someone has
invested time and energy in the existing operations
and will find proposed revisions unsettling. So,
including steps in the problem solving method that
explain “what’s in it for me” and accommodate
stakeholder needs can secure process modifications.
Table 3 (p. 28) illustrates an approach to
improvement and change that will ensure a suc-
cessful conclusion while minimizing resistance.
Steps to Secure Improvement
The following action steps for change describe
how to implement and secure process improvements.
S T E P : Define the need and necessity for mak-
ing improvements. The objective is to reduce com-
placency and ambivalence. But the effort should be
more than an awareness campaign, yet not so dog-
matic that people immediately tune out. Consider
using some of these resources as a basis for making
the need obvious:
• Benchmark shortcomings against competitors
or leaders in the organization’s market.
• Document and display information about
complaints from customers, clients and stake-
holders.
• Document and display data related to rejects,
QUALITY PROGRESS I NOVEMBER 2007 I 27
PROCESS IMPROVEMENT

rework, scrap or the routine failure to main- STEP : Identify formal and informal work
tain process control. alliances and ensure their participation. Although
• Question waste caused by complexity, bureau- there is an overwhelming tendency for problem
cracy, overproduction, excess inventory, trans- solvers to charge ahead because of familiarity with
portation, waiting time and unnecessary the situation, doing so can leave out critical voices.
motion. Time should be spent preserving relationships and
• Expose excesses in spending and the inappro- creating opportunities for involvement. Don’t
priate use of resources. assume that acceptance will be automatic.
• Rationalize the benefits of improvement by Support can be secured by using some of these
explaining the ease of future operations and approaches:
the rewards that are derived through change. • Communicate with groups impacted by the
change with assurance that their input is wel-
S T E P : Create and communicate a unifying comed and desired.
purpose. This should be more than a set of well- • Invite work groups and stakeholders, particu-
crafted words or an announcement seeking com- larly those who did not have direct involve-
mitment. It should convey a sense of reason that ment, to an informational meeting where
allows others to have a stake in the future. purpose is reviewed, questions are answered
Understand and describe what customers, clients and input is accepted.
and stakeholders expect from the organization, and • Build trust by displaying management behav-
link it to proposed improvements or changes. ior that is open, fair, accommodating to feed-
Analyze and portray the desired end using terms back and true to promises.
with market appeal. • Look for opportunities for stakeholders, par-
A well-stated goal should have the following ticularly informal leaders, to participate in the
characteristics: process of change and improvement.
• It is brief and well focused so it can be easily • Let work groups and stakeholders know how
communicated and explained. they are appreciated and how they can sup-
• It conveys a picture of the future or desired end. port the project.
• It says something enabling and appealing to
both stakeholders and customers. STEP : Create a plan for action. This is when
• It is realistic in its purpose so the end appears the details for making the improvement operational
obtainable. and permanent are worked out. Planning is not dif-
ficult and is fairly straightfor-
ward. Individual approaches and
TABLE 3 Steps for Securing Improvement techniques can be used, but the
completed plan should sequence
Problem solving framework Change steps and schedule tasks.
1. Identify and define the problem. This is also the step in which
2. Describe and measure the process affected. methods for reducing and
3. Identify and analyze causes. accommodating resistance
4. Develop a solution that addresses causes.
should be considered and incor-
5. Plan and implement process improvements. 1. Define the need and necessity for change. porated. A typical plan should
2. Create and communicate a unifying purpose. contain these elements:
3. Identify formal and informal work alliances,
and ensure their involvement.
• A method for determining
4. Create a plan for action. constraints or issues that
might become barriers to
6. Evaluate outcomes and make any required 5. Empower people to take action.
modifications. 6. Create opportunities for small, meaningful implementation.
accomplishments. • Requirements for neces-
7. Standardize and integrate into daily work. 7. Expand accomplishments by completing
sary equipment, materials,
unfinished change activities. people and training so
8. Reinforce the new approach. implementation tasks

28 I NOVEMBER 2007 I www.asq.org

 are considered and scheduled.
• A sequence of steps that will map out tasks
required for completing the transformation.
• An estimate of time for the completion of each
task so deadlines become apparent.
• An assignment of responsibilities for tasks so
activities are realized and completed.
STEP : Empower people to take action.
Empowerment is the process of power sharing
between work groups and their leaders. It is
defined by a relationship in which members are
granted authority to make changes and accept the
responsibility for decisions related to those actions.
Empowerment implies there is a defined purpose,
freedom to make choices and sufficient support to
complete assigned activities. Disempowerment, on
the other hand, fosters ambivalence, stifles momen-
tum and increases resistance. Table 4 identifies barri-
ers to empowerment.
The following activities support empowerment
and advance the process of change.
• Ensure skills are sufficient by providing train-
ing so people are capable of operating in a
new environment.
• Provide a mechanism for addressing injustices
and providing political clout to deal with power
structures that undercut change activities.
• Ensure that decisions made by work groups
are not reversed without member consultation
and consent.
• Place responsibility for the nitty-gritty details
of getting work done in the hands of informal
leaders and process operators who have the
insight and capability to complete transforma-
tion activities.
STEP : Create opportunities for small,
meaningful accomplishments. Transition activities
of moderate importance create a sense of satisfac-
tion when completed. By itself, the result might
seem to be of minimum importance, but as these
small achievements accumulate, they show
advancement that can win allies and soften resis-
tance.
When people can begin to measure progress and
visualize a successful conclusion, forces activate
that are more favorable to completing another step.
Success tends to attract more success. Here are
some reasons small improvements work:
TABLE 4 Barriers to Change and
Empowerment
• Lack of a clear focus or purpose.
• Decisions that are detached from solid information or facts.
• Plans that are self-serving and undermine proposed goals.
• Requests without explanation.
• Questioning without listening.
• Saying one thing and doing another (not walking the talk).
• Increasing responsibility without granting full authority.
• Demanding changes without providing sufficient resources.
• Not providing a method of recourse for injustice.
• Not sharing the rewards with those who produced the results.
• They are more attainable because risks and
costs are low and the fear of failure is reduced.
• They reinforce the idea that effort will pro-
duce results.
• They provide a sense of achievement and sat-
isfaction.
• They enhance the feeling of competence and
ability.
• They reinforce the feeling of individual con-
trol under difficult circumstances.
• They create interest and optimism in the next
set of activities.
STEP : Expand the accomplishments and
complete the unfinished change activities. This is
the point when new structures, work operations,
communication links and relationships are formed.
It is the stage when old interdependencies are dis-
rupted and new ones established.
However, as these separations and connections
are made, resistance can reassert pressure to main-
tain old and familiar alliances. Maintaining momen-
tum, re-establishing focus and ensuring support are
critical at this point so the project doesn’t bog down
or derail. This can also be the time when people
want to prematurely declare success, but the job is
not complete and backsliding is possible.
Here are activities that can keep the transforma-
tion process on track and ensure completion:
• Managers and supervisors must begin to lead
by example and exemplify how the new way
will work.
• Continue to stay the course, but be flexible
QUALITY PROGRESS I NOVEMBER 2007 I 29
PROCESS IMPROVEMENT

and ready to make adjustments when new
patterns prove unworkable.
• Redesign and begin to shift formal and infor-
mal structures, including communication
processes, so they are compatible with new
objectives.
• Redesign and begin to shift individual work
activities so they support structural changes
and new objectives.
• Maintain control through guidance by acting
as a mentor or coach, but allow people to
experience the change by identifying and seiz-
ing on opportunities in which new skills,
behaviors and relationships can be tried out.
STEP : Reinforce the new approach. Al-
though the job of improving the system or related
process might appear successful, some things still
need to be done to keep people from reverting to
familiar patterns of behavior and work. Here are
techniques for locking the new approach in place:
• Acknowledge and celebrate the accomplish-
ments and hard work of all supporters and
stakeholders.
• Continue to monitor and measure system out-
puts for efficiency and quality.
• Continue to monitor system decision making
and how people relate to one another.
• Initiate problem solving if outputs or behav-
iors fall below acceptable expectations.
• Acknowledge and reward those who continue
to ensure system performance and supportive
relationships.
Table 5 shows an example of how these steps
and actions were applied.
Standardizing the Results
Successful problem solving and improvement

TABLE 5 Case Study on Securing Change

Steps
Define the need
and necessity for
improvement.
Create and communicate
a unifying purpose.
Identify formal and informal
work alliances and ensure
their participation.
Create a plan for action.
Empower people
to take action.
Create opportunities
for small meaningful
accomplishments.
Expand accomplishments
and complete unfinished
projects.
Reinforce the new
approach.
Actions
1. The president sent a letter to all employees explaining the benefits and reasons for a quality system
meeting ISO 9001 standards.
2. The customer letter requesting compliance to ISO 9001 standards was posted on bulletin boards.
3. A letter of noncompliance from the customer and reject information were posted on bulletin boards.
1. The steering committee affirmed the meaning, purpose and direction of the company mission and vision statements.
2. The steering committee crafted a statement defining the ISO 9001 implementation project.
1. The steering committee identified critical department linkages and connections based on ISO 9001
clause requirements.
2. Supervisors and informal leaders met with the steering committee to determine how department
linkages and connections would be structured.
1. The steering committee revised the implementation plan.
2. Due dates were established.
3. Work teams were established, and responsibility for plan activities was assigned.
1. Work teams received training on ISO 9001 clause requirements and team techniques.
2. Responsibility and authority for project decisions and actions were given to work teams with the steering
committee acting as the arbiter for disputes.
3. Work teams picked their leaders and created project charters for assigned tasks.
4. Progress reporting dates were established.
1. Customer measurement, analysis and improvement issues were fast-tracked as a project.
2. Procedures and work instructions were reviewed and corrected by work teams.
3. Processes began to operate accordingly.
1. The steering committee addressed issues of responsibility, authority and communication for the quality
management system.
2. Functional areas began operating under the new structure, with the president and steering committee
acting as the arbiter for disputes.
1. The steering committee monitored team activities, behaviors and outputs.
2. The steering committee monitored new functional structures for effectiveness.
3. Accomplishments were acknowledged and celebrated.

30 I NOVEMBER 2007 I www.asq.org

require more than the discovery of a workable
solution. At some point, the results need to become
part of daily routines and locked into place so new
practices don’t revert to familiar, less productive
habits. Using action steps during the solution im-
plementation phase to secure change will ensure
results become standardized.
The expression “Change would be easy if it
wasn’t for the people” is often used by agents for
improvement. However, the energy for making
things work and getting things done is supplied by
those affected by process alterations.
Equitably addressing concerns and fears should
become a matter of practice when reordering oper-
ations. Simply providing information and exhort-
ing modified behavior is seldom successful. People
rarely change because they are pushed, told or
warned. Such appeals typically serve to heighten
tension and prolong resistance.
The goal of improvement is more than resolution.
It is the triumphant installation of a corrective action.
This happens when the latter steps of problem solv-
ing include activities that fix changes in place so oth-
ers in the future will not face the same old problem.
REFERENCE
1. John P. Kotter and Leonard A. Schlesinger, “Choosing
Strategies for Change,” Harvard Business Review, January-
February 1979, p. 57.
JOHN R. SCHULTZ is a management con-
sultant based in West Bend, WI. A retired
college professor, he administered an
advanced technical certificate program in
quality management. Schultz earned a
master’s degree in management from
National-Louis University, Evanston, IL.

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QUALITY PROGRESS I NOVEMBER 2007 I 31

AUDITING
Improving the
Internal Audit
Experience
by Theresa Wasche and Nancy Sciortino
W
hen your company prepares for an
audit, do you feel as if everyone is on
the same page?
Sure, the people engaged in the process—and
representing the organization during the audit—
are qualified individuals who do their jobs very
well and positively contribute to the whole of the
organization.
But do they know what’s coming in an audit and
In 50 Words
Or Less
• Employees don’t always understand how audits relate to
ensuring the use of sound business processes.
• Many don’t realize the significant process improvement
benefits that can be achieved from an internal audit
experience.
• Cerner Corp. developed training to help its employees
understand and better prepare for the auditing process.
32 I NOVEMBER 2007 I www.asq.org
what signification process improvements could
result from it? Are they fully prepared for what the
auditors will ask and request?
Regardless of the industry, most quality manage-
ment system (QMS) regulations or standards
require the development and maintenance of an
internal monitoring process to ensure ongoing
compliance with the regulations or standards.
Internal process or compliance audits are one of
the key processes many corporations use as their
internal monitoring system to determine whether
groups are in compliance with their QMS. Internal
auditors might find, as we did, that personnel par-
ticipating in audits usually are not familiar with
why an audit is being conducted, and the person-
nel are not fully prepared to participate in the
audit.
Our theory is that employees don’t understand
how the audit relates to ensuring the use of good
business processes. Employees don’t realize the
process improvement benefits that can be achieved
through the internal audit experience.
Employee Survey Says
At Cerner Corp., a healthcare IT company head-
quartered in Kansas City, MO, we decided to ask
our employees about their audit experiences. In
2004, our internal audit group began surveying
audit participants after internal audits. The survey
consisted of a list of questions related to the per-
son’s level of satisfaction and the overall audit
experience.
The overriding question was this: Did groups
benefit from audit preparation, including the audit
meeting and the audit report?
In short, the answer was, “Not really.”
Initial results from the survey indicated personnel
were not satisfied with their level of audit prepara-
tion and did not believe the audit was a beneficial
experience overall. Clearly, our methods were not
meeting the needs of the corporation.
We conducted a root cause analysis of the problem
and determined that the lack of any audit prepara-
tion training was one thing that required corrective
action. We determined we needed a training course
that would:
• Increase personnel’s understanding of the
audit process.
• Set expectations related to each employee’s
role in the audit.
• Provide insights into the benefits of the audit
process as a whole.
In researching staff educational needs, we found
that most external training available emphasizes
the how-to’s of conducting audits as opposed to
how to effectively participate in an audit.
It is important to note that the training was intend-
ed to be geared toward closing the existing knowl-
edge gap, not teaching them how to pass an audit.
Educating personnel to be professional, exude con-
fidence, be on time and review documentation prior
to submitting it to the auditor does not jeopardize an
auditor’s objectivity in performing an internal audit.
It only makes the auditor’s job more effective by
allowing him or her to spend more time on the com-
plicated or sophisticated processes and do a much
more thorough assessment of overall compliance.
Results of Employee Training
As the result of our research, we designed, con-
ducted and monitored the results of the course to
determine its overall effectiveness. What we found
indicated that groups audited after completing the
training course were proactively conducting their
own reviews of internal processes and were imple-
menting corrective actions prior to the actual audit.
Data from our internal audit system conducted
between 2004 and 2005 showed a 29% reduction in
the number of hours auditors needed to prepare
for and conduct internal audit meetings when par-
ticipants received the audit preparation training
and prepared appropriately.
Audit meetings that had normally taken eight
hours to complete were now taking only an aver-
age four to six hours due to group preparedness.
Today, personnel provide thorough explanations of
processes during internal audits and are able to
provide documentation as evidence to support
their compliance with the process.
Groups that do not have personnel complete the
education course prior to the internal audit meeting
continue to struggle today with audit preparation
and participate minimally in the internal audit
process. They are unable to adequately provide evi-
dence or documentation to support compliance to
processes. Simple requests, such as asking the group
to provide a documented organizational chart, con-
tinue to be a challenge for these groups.
Following the rollout of the introduction to
auditing course, we found that groups began
requesting internal audits and soliciting consult-
ing advice from our regulatory affairs/quality
assurance consulting group. This new trend indi-
cated that groups were beginning to comprehend
that the audit experience could be a valuable vehi-
cle for identifying improvement activities.
Additionally, internal audit survey data since
2004 has consistently shown that 93-95% of person-
nel audited now report satisfaction with the inter-
nal audit experience.
Beyond Just the Audit
The introduction to auditing course has provided
benefits beyond just preparing personnel for inter-
nal audits. Personnel who have participated in the
course are now prepared, confident and profession-
al when interviewed during external regulatory
inspections and surveillance accrediting audits.
Personnel’s preparation contributes to our ability to
maintain corporate compliance and accreditation
with ISO 9001 and ISO 13485 standards.
In addition, groups are not waiting for an internal
audit to be scheduled for their group before they take
action. Since 2004, there have been several instances
(continued on p. 36)
QUALITY PROGRESS I NOVEMBER 2007 I 33
AUDITING

Introduction to Auditing Course

Figure 1 illustrates how Cerner so be sure your objectives emphasize material presented prior to a specific
Corp. used the plan-do-check-act using audit preparation as an appro- audit event at their convenience.
(PDCA) process approach to success- priate defense for anticipated anxiety. Design the course content around
fully design and develop the introduc- An example of a course objective your course objectives. Audit method-
tion to auditing course. The following might be to provide personnel with ology can be a dry subject, so use a
breaks down each step in the the knowledge and skills required to variety of educational techniques to
approach and offers some lessons effectively participate in an audit. increase interest and relevance.
learned. Consider using one or more of the
Do: Create and conduct the course following in your course design:
Plan: Define course objectives Determine the most effective train- • Slide presentations.
• Assess the demographics of your ing medium based on your organiza- • Process diagrams or flow dia-
target audience and identify the ben- tion’s business processes and your grams.
efits of completing an audit prepara- course objectives. Consider corporate • Video or audio clips demonstrat-
tion course. Be prepared to create a hours of operation and personnel ing best practices or sharing typ-
course in which personnel can open- locations. Will you need to develop a ical audit experiences. (Person-
ly face and overcome their audit anxi- web based course in addition to an nel enjoy seeing other people in
eties, fears and concerns. Consider instructor led class to maximize avail- the corporation poking fun at
those factors as parts of your learn- ability? What resources will person- corporate nuances.)
ing requirements. nel use in the course? Are those • Frank and open discussions
Define the objectives of the course resources readily available? What with the auditor. For example,
based on your learning require- course format will best suit the learn- we included discussions on
ments. Keep in mind that your audi- ing needs, and which format will best both positive and negative
ence will probably experience some present the course content? audit perceptions. We dis-
level of trepidation in any situation, At Cerner Corp., developing a web cussed the emotions partici-
based training module in pants experience when they
FIGURE 1 Plan-Do-Check-Act Cycle addition to instructor led hear the word “audit.”
And Audit Course classes was necessary to • Role-playing activities that in-
maximize the availability volve the course participants as
of the course for person- both the auditor and auditee.
Define course nel at all of our global This activity provides partici-
objectives (plan)
locations. pants the opportunity to experi-
• Identify audience
• Identify benefits The advantages for us ence the audit in a safe
of having a web based environment and practice how
Create/conduct
the course (do)
Correct/improve
version of the course they would respond to an audi-
• Define course content Introduction the course (act) included: personnel were tor’s questions.
and format to auditing
• Define delivery modes education Update course able to complete the train- • Competency review or a quiz to
• Define competency course content as needed
method ing course anytime, day or assess each participant’s under-
• Present the course
night; the need for instruc- standing of the material.
Monitor course tors and training room • Pocket-sized reference guide of
effectiveness (check)
• Conduct surveys facilities at all locations the audit life cycle (see Figure 2).
• Review audit findings
• Review audit was eliminated; and per- Conduct the course. We recom-
related metrics sonnel were able to repeat mend you present the course to a
the course or reference the pilot group to obtain initial feedback

34 I NOVEMBER 2007 I www.asq.org

on course material and to assess the
perceived value of the course. From
there, you should allow ample time
to improve the course material based
on the feedback received from the
pilot group. Schedule the course at
various times throughout the year to
allow groups many opportunities to
complete it prior to participating in
an audit.
Advertise your course. Use existing
corporate media and online commu-
nication tools, such as corporate
newsletters, published articles, corpo-
FIGURE 2 Audit Life Cycle
Understand corporate and group processes
Policies, procedures, regulations
and accreditation standards.
Prepare for the audit
Gather documentation, review documentation,
determine attendees, understand
scope and review audit checklist.
Conduct audit follow-up session
Opening meeting, requirements review, data
review, discussion and closing meeting.
Analyze and report findings
Audit report issued and reviewed
by audited group and executives.
Carry out corrective and preventive actions (CAPA)
CAPA records created, follow-up
meetings conducted and action
plan identified and documented.
Complete audit closure
Response to CAPA accepted and approved
and management notified.
rate training catalogs FIGURE 3 Nonconformance Trends
and internal audit
notifications to adver- 18
tise the course’s avail- 16
14
ability. Also consider
12
adding the course as
10
part of the overall
8
quality management
6
system training cur-
4
riculum for your orga- 2
nization. 0
2004 2005 2006 2004 2005 2006
If audit preparation
Documentation Training
meetings are conduct-
ed with the groups,
the availability of the trolled.
course should be included on the Another area at Cerner that
meeting agenda. showed marked improvement since
2004 was corporate and role based
Check: Monitor course effectiveness education.
Develop methods to assess the Before 2004, groups often were
effectiveness of the course in achiev- unable to provide documented evi-
ing your training objectives. Consider dence that personnel had been
the following: trained to perform their current roles.
• Survey audit participants to Since 2004, the number of noncon-
assess the perceived value. formances identified in internal
• Review audit survey and audit audits relating to training has
program metrics to ensure par- dropped by 100%, as shown in
ticipant satisfaction levels are Figure 3.
acceptable or increasing.
• Review internal and external Act: Continually improve the course
audit report findings for groups Update course design and content
that have participated in the periodically based on your review
course and compare to audit and assessment of the effectiveness
findings for groups that have indicators. Review the course annual-
not. Document the gaps identi- ly to ensure the content is current,
fied. relevant, fresh and interesting.
At Cerner, we found that between Report course effectiveness and
2004 and 2006, the number of non- data to executive management on a
conformances related to documenta- periodic basis to show the overall
tion management decreased by 88%, positive impact audit preparation
which indicated that groups were training has on the state of overall
spending more time ensuring docu- corporate quality compliance. –T.W.
mentation was completed and con- and N.S.
QUALITY PROGRESS I NOVEMBER 2007 I 35
AUDITING

(continued from p. 33)

when groups have contacted the regulatory that they were continuing to maintain compliance with
affairs/quality assurance group voluntarily and corporate standards.
requested that their group be audited. Most of these Management and maintenance of an effective
groups were newer groups that either expanded or internal audit program should not only provide
changed their scope of responsibility or drastically trained staff to conduct audits, but also should
changed their processes. The groups want to verify ensure that employees understand what audits entail
and why they are important to the
business. Successful internal audi-
tors will spend the time required to
effectively educate and prepare
their organizations for positive
audit experiences.

FRESH
By providing awareness of what
to expect from the internal audit
experience, auditors take away the
mystery and confusion associated
with audits while still maintaining
SPC charts their objectivity and credibility as
internal auditors.

Instantly
BIBLIOGRAPHY
from any data ANSI/ISO/ASQ Q9000-2000, Quality
source Management Systems Requirements, ASQ
Quality Press, 2000.
“Developing the Facilitator in You,”
Cerner Corp. internal training course,
2003.
Point,
P i click,
li k chart Russell, J.P., The Quality Audit Handbook,
second edition, ASQ Quality Press,
Download a 30-day trial at www.pqsystems.com 2000, pp. 137-173.

CHARTrunner is SPC software that fetches data from Excel, Access,

Oracle, SQL Server, and other databases to generate up-to-the-minute THERESA WASCHE is lead internal audi-
charts. It is the only process charting software that always provides tor for Cerner Corp. She earned a bache-
fresh charts with no lor’s degree in medical technology from
importing, exporting, Northern Michigan University in
copying, or pasting. Marquette. Wasche is certified as an
You’ve really got to RABQSA quality management systems
see it to believe it. lead quality auditor, ASQ quality audi-
tor—biomedical and quality systems lead
auditor. She is a senior member of ASQ.

NANCY SCIORTINO is a senior regulato-

Call 800-777-3020
ry affairs specialist and audit leader for
Cerner Corp. She has a bachelor’s degree
in medical technology from Creighton
University in Omaha, NE. Sciortino is a
North and South America Australia and Asia Europe and Africa certified quality management systems
800-777-3020 03-9770-1960 01704-871465
RABQSA lead auditor and a member of
ASQ.

36 I NOVEMBER 2007 I www.asq.org

AUDITING
Turbocharge Your
Preventive
Action System
by Murray J. Sittsamer, Michael R. Oxley and William O’Hara
In 50 Words
Or Less
• A layered process audit is an ongoing chain of
simple verification checks that ensure a defined
process is followed correctly.
• This powerful management tool can improve
safety, quality and cost savings by amplifying
problem solving systems and making continuous
improvement almost routine.
ith increased global competition, U.S.
W manufacturers are relentlessly looking
for new ways to improve quality and
productivity and to lower costs. One quality tool—
originally launched as a quality improvement initia-
tive—can be used to do all three.
A layered process audit (LPA) goes beyond inspec-
tion of work by actually transforming a company’s
culture into one that embraces continuous improve-
ment.
Accepted quality systems, such as ISO 9000 and
the Baldrige criteria, specify that management is
responsible for establishing and maintaining systems
and procedures that effectively produce quality
QUALITY PROGRESS I NOVEMBER 2007 I 37
AUDITING
results. An LPA is one way to engage leadership in
verifying that the systems they assume are in place
are indeed present and effective. Beyond verifica-
tion, LPAs—conducted by all layers of leadership—
demonstrate top leadership’s personal commitment
to quality.
Hundreds of automotive suppliers have imple-
mented LPAs. General Motors initially introduced
LPAs to suppliers in 2002. DaimlerChrysler made
LPAs a supplier requirement in 2004. To reduce
variation in interpretation of requirements, the
Automotive Industry Action Group (AIAG) pub-
lished CQI-8—Layered Process Audits Guideline in
December 2005.
Start With the Basics
In short, an LPA is an ongoing chain of simple
verification checks. Through observation, evalua-
tion and conversations on the manufacturing floor,
these checks ensure key work steps are performed
properly. These interactions are also an excellent
way for managers to show respect for frontline
workers.
Unlike management, accounting or quality sys-
tem audits that result in reports to leadership, LPAs
are intended to verify for operators and frontline
supervisors that things are going right. If they’re not
going right, the audits guide correction of the find-
ing (nonconformance) on the spot.
If the problem recurs or is found in other work
areas, then the problem might be viewed as sys-
temic and on an exception basis, bubbling up for
management review and problem solving activities.
Most often, the quality department develops the
LPA checklists in conjunction with the operations
TABLE 1 Layered Process Audits at BorgWarner
ppm Percentage of improvement
Calendar year defective (year-to-year)
2002 591 NA
2003 66 89%
2004 36 45%
2005 22 39%
2006 (through June) 14 36%
ppm=parts per million
38 I NOVEMBER 2007 I www.asq.org
or manufacturing staff. It’s helpful to use a team
approach and include those who carry out the work.
In LPAs, only the top risk items for safety and
quality are incorporated into the checksheets, plac-
ing focus where it is needed most. LPA checks
should be performed only on conditions that vary
daily, such as the presence of machine guarding,
operator craftsmanship, condition of tools and
effectiveness of fail-safe devices.
Different layers of management and various staff
should perform LPAs for any given line on a set
An LPA is nothing more
than a disciplined way
to verify that work is
performed the way it
was intended.
schedule. This ensures that many sets of eyes from
all levels of management can view the process.
LPAs help protect operators from injury and also
protect customers and plants from shipping non-
conforming products. But that’s only the tip of the
iceberg. It’s less costly to have fewer injuries and
manufacture products correctly the first time, and
LPA checksheets that focus on process inputs will
help achieve first-time quality.
In every organization, things get in the way of
people doing their best. For operators performing
repetitive tasks, it’s sometimes difficult to repeat
motions without error. Some operators might
become careless, make simple mistakes or take
well-intended shortcuts that change a process.
Machines are also prone to error. Left unvalidated,
tools can wear, machines might malfunction, and
settings are adjusted needlessly.
The positive outcomes of LPAs are that you
know the processes were run correctly because you
were able to personally verify them. You weren’t
taking anyone else’s word for it—you actually saw
and touched the process. LPAs also let top manage-
ment systematically become more familiar with
shop floor activities and build a relationship
between management and shop floor personnel.
LPAs are not the typical audit of the product.
Instead, they are an audit of the process. In a process
audit, you check to see that the operator is following
the defined process. LPAs ensure that the critical
process parameters, such as machine settings, tem-
peratures, flow rates and gages, were set correctly. If
the defined parameters were set correctly, the
process will make good parts. In a product audit, you
only check to see if the part was within specification.
One Manufacturer’s Success
BorgWarner’s powertrain plant in Muncie, IN,
implemented LPAs in early 2003. In time, the plant’s
original equipment manufacturer (OEM) customer
assembly plant reject rate for a specific new assembly
line, measured in parts per million defective (ppm),
quickly dropped almost 90%, from 591 to 66. From
2003 to 2006, the rate continued to drop and its ppm
fell below 15 (see Table 1). The average ppm reduction
during the past three years was 40% year-to-year.
When used effectively, LPAs can find and reduce
the variation prevalent in any production workplace.
When variation of product is reduced, operations
flow more smoothly, and customer satisfaction and
employee morale increase. This, in turn, can lead to
significant cumulative cost savings.
During the past two years, many automotive
parts suppliers have implemented LPAs. OEMs
see LPAs as one of the most powerful activities to
make good suppliers better, or take great suppliers
and prevent their quality metrics from declining.
Many customer quality concerns are caused by not
following the process or by having a false sense of
security that the error proofing in place still works.
By eliminating errors that would otherwise be caught
during inspection—or worst-case scenario, by the
customer—LPAs have a significant impact on reduc-
ing wasteful costs of rework, sorting and tending to
customer quality concerns. With higher yield rates
and less downtime, throughput productivity mea-
sures also are improved.
This can be clearly seen in the BorgWarner pow-
ertrain plant. Using the final assembly line as an
example, the line supervisor conducts audits dur-
ing each shift daily. Each week, the area manager
audits the same line using the same checksheet the
supervisor used. Each month, the plant manager
TABLE 2 Example of Audit Layers
And Frequencies
Layer Example Audit frequency
1 Supervisor One per shift every day
2 Area manager Two per week
3 Plant manager One per week
does the same using the same checksheet as the
supervisor and area manager.
Other companies might choose different audit lay-
ers and frequencies. Be sure to check with your cus-
tomers to determine whether they have specific
requirements. Table 2 provides the audit layers and
the frequencies used most often by DaimlerChrysler
suppliers.
People Respect What You Inspect
Though relatively new in name, the concept of
LPAs will not be foreign to plant floor management.
An LPA is nothing more than a disciplined way to
verify that work is performed the way it was intend-
ed. When supervisors and managers are too busy or
distracted to verify work and provide feedback,
there are some potentially negative consequences.
These consequences are costly because:
• Errors and omissions might occur without
correction.
• Poor habits develop and can become the de
facto standard.
• Employees might become frustrated and
unmotivated when they receive no feedback
on performance for extended periods of time.
It’s been said that people will listen to what you
say, but they’ll do what you inspect. By nature,
human beings are flexible, innovative and error
prone. Regardless of an operator’s experience,
knowledge and attentiveness, the lack of timely,
relevant and accurate feedback is sure to have a
negative impact on performance.
LPAs give operators subtle but well-deserved
recognition. LPAs show respect for operators by
telling them whether they are complying.
Nothing Is Immune to Variation
LPAs are not as technically sound as error proofing,
so LPAs should never be counted on as a detection
QUALITY PROGRESS I NOVEMBER 2007 I 39
AUDITING
control. But even error proofing is not always shielded
from variation and failure. Though sometimes called
fail-safes, these devices can be misaligned, damaged,
miscalibrated or even turned off. Also, human error
can undo almost any system or safeguard. According
to Meta Group, a technology consultancy, using tech-
nology to combat errors is only 20% of the solution.
The company culture that interacts with the technolo-
gy makes up the other 80%.
When the requirement is zero defects, the only way
to ensure no shipment of nonconforming product is to
develop a culture in which each person works toward
“the right way the first time, every time.” An orga-
nization’s quality culture is just as important—if not
more so—than its quality system (for example, its
equipment, procedures and training).
Auditors must evaluate observations against
established standards and requirements. Since a
person unfamiliar with a process cannot indis-
putably judge whether a setting or task is proper
or correct, LPA questions must include a descrip-
tion of the specific requirement.
For example, rather than verifying that the tool
was set up correctly, a checksheet question might
verify that the drill bit was “fully seated in the
pocket and rotates without wobble.”
Conducting LPAs is easy. Developing LPA ques-
tions takes careful thought and effort.
TABLE 3 Sample Layered Process Audit (LPA)
Checksheet Questions
LPA check item Yes No Comments
Is nonconforming product contained and separate
from conforming product?
Does the press stop when the cup plug is omitted
(error proofing verification)?
Are machine settings consistent with those specified
on the setup sheet?
Are employees wearing the proper personal protec-
tive equipment (safety glasses, shoes and ear plugs)?
Is all product in the cell identified with a part
number and production status?
Does the part meet specification, using go/no-go
gage 555748 (deep hole drill)?
Checking part, does the gage read less than
0.004 test-in reliability?
40 I NOVEMBER 2007 I www.asq.org
Front Line, Not Front Office
Truth be told, it’s really the front line, not the
front office, that impacts quality minute by minute.
Let’s look at how an audit can be carried out on
the plant floor. A work area might have a checklist
with five to 12 questions specific to the related work
processes. Every shift of every day, the area’s super-
visor will walk the line and check all the items on
the checksheet. This will usually take 10 to 15 min-
utes each shift, or it can be completed during the
supervisors’ regular walks around the department
throughout the day.
A checksheet question might be, “Is the press
temperature set between 190 and 195 degrees
Fahrenheit?” The question might appear if the tem-
perature setting was deemed critical to the quality
of the product.
If an LPA checksheet item is found to be noncom-
pliant (for example, the temperature was found to
be too low at 187 degrees), the situation should be
fixed immediately. LPAs should verify conformance
to process specifications and remedy any discrep-
ancies found. LPAs should not be used solely to cre-
ate lists of findings and recommended actions.
If the problem is caught early, there might be no
impact to the part’s quality and the root cause
could be fixed immediately.
During every shift, many work elements were
verified at the BorgWarner plant. When
possible, noncompliances were correct-
ed immediately. If they could not be
fixed, additional checks were made to
verify product conformance, and action
items were communicated to the
responsible individuals. Sample ques-
tions from the Muncie plant’s LPA
checksheets are in Table 3.
Specifically at the BorgWarner plant,
extensive errorproofing was built into
press fixtures with a variety of sensors.
The LPA auditors ran several checks of
each fixture daily to verify that the
press would fault when any of the
required components were omitted.
Turbocharge Preventive
Actions
Implementing an LPA is like putting
a turbocharger on both a plant’s pre-
ventive and corrective action systems. An LPA can
amplify the power of problem solving systems so
solutions are put into place—and stay in place.
Then continuous improvement becomes a way of
life. Benefits can be significant without additional
manpower.
Daily LPAs identify problems far upstream, per-
haps days or weeks before a customer might other-
wise identify a problem. Management involvement
in the LPAs and regular reviews of the most fre-
quent nonconformances help guide the appropri-
ate resources to fix the problem.
A well-executed LPA makes management’s
presence on the plant floor commonplace. When
managers routinely take the time to understand
operators’ concerns, operators become more will-
ing to volunteer suggestions for improvement and
question potentially detrimental situations. That’s
why LPAs can make such a significant impact on
people and operations.
Before every flight, an aircraft’s pilot has a
checklist to make sure all systems work before
heading down the runway to take off. An LPA
checklist is similar in that it identifies the impor-
tant items in the process to ensure a quality prod-
uct. It can be used at start-up or, more commonly,
throughout the day. When the flight, or day, goes
smoothly, managers and operators can use the time
saved to work on improvement of marginal pro-
cesses and further preventive action.
Verify, Verify, Verify
Like any other change effort, implementation of an
LPA requires high level management commitment,
awareness, understanding and thoughtful planning
to ensure connection to other systems. If any of these
are missing or shortchanged, it’s likely you’ll be
pushing uphill. The effort to implement and even
conduct daily audits will far exceed any benefit.
The simple action of a plant manager completing
a 15-minute LPA checksheet for one assigned area
of the plant each week broadcasts the message that
verification of proper process control as priority.
In the big picture, LPAs are part of the checks
and balances needed to ensure that defined sys-
tems are followed. During the audits, leadership is
checking that people are following the systems,
and at the same time they’re getting feedback to
ensure that the systems are effective.
Getting to the Heart of the Matter
The law of entropy tells us that systems deterio-
rate over time. Even corrections put into place
today might be ignored, forgotten or misplaced
tomorrow, next week or next month. A working
LPA system would add a new question to a plant’s
existing checksheet related to holding a new cor-
rective action in place.
For example, a new question might be, “Misbuild
Like any other change effort,
implementation of an LPA
requires high level management
commitment, awareness,
understanding and thoughtful
planning to ensure connection
to other systems.
one casing by omitting the bracket. Does the [new]
errorproofing device at station 15 detect a missing
bracket and guide the casing onto the rework table?”
In this example, if the error proofing is known
to be working on every shift, it’s unlikely a casing
will be built and shipped without the bracket ever
again. As previously experienced problems are
prevented from recurring and risks are controlled
through LPA verification, managers and operators
have more time to do the work at hand without
the frustration and distraction of investigation,
downtime and consequences imposed by the cus-
tomer.
With LPAs verifying that desired methods stay
in place, firefighting is reduced and more time is
left for project work and continuous improvement
activities. Like a turbocharger, LPAs can give more
power to your preventive action system with no
outside energy required.
More Than Just a Single Audit
You can’t expect to find all problems by doing a
15-minute check once each shift. But conducting
QUALITY PROGRESS I NOVEMBER 2007 I 41
AUDITING
brief LPAs every day on elements critical to
quality that are most likely to vary can have a
tremendous impact on safety, quality and cost.
An LPA is a tool to help manage a work
process and keep it from going off course. A
consistently performed process creates a stable
product, reduces costs and increases produc-
tive work time.
Companies that see the value of the LPA
strategy choose to perform LPAs for their own
benefit, not to satisfy a customer requirement.
Targeted questions, adherence to daily audits
and management follow-through on issues
found during daily audits are key indicators
of a plant’s genuine commitment to its cus-
tomers and its employees, and of its ability to
get better.
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42 I NOVEMBER 2007 I www.asq.org
By ensuring that standardized procedures are in
place, an organization will move from one that mini-
mally complies to one that has quality, conformance to
product, and process requirements as its top priorities.
Improvements in customer quality can save thou-
sands of dollars in sorting, containment and corrective
actions. Within a few months of properly implement-
ing LPAs, improvements can be seen in customer
quality, repair and rework, productivity, safety and
even employee morale.
BIBLIOGRAPHY
Automotive Industry Action Group, CQI-8 Layered Process Audit
Guideline, December 2005.
Bafna, Sudhir, “The Process Audit: Often Ignored but Never
Insignificant,” Quality Progress, December 1997, pp. 37-40.
Banham, Russ, “The Enemy Within,” CFO Magazine, October
2004.
Craig, Darin J., “Stop Depending on Inspection,” Quality
Progress, July 2004, pp. 39-44.
Grove, Andrew S., One-on-One With Andy Grove, Penguin
Books, 1987.
Read, Robin, “A Checklist for Managers,”
www.improve.org/mbwa.html, 1999.
MURRAY J. SITTSAMER is president of the
Luminous Group in Farmington Hills, MI.
He holds a master’s degree in industrial
administration from Carnegie Mellon
University in Pittsburgh. Sittsamer is a
senior member of ASQ.
MICHAEL R. OXLEY is a quality manager
at BorgWarner in Muncie, IN. He earned
a bachelor’s degree in mechanical engi-
neering from Purdue University in West
Lafayette, IN. He is a member of ASQ and
a certified quality systems auditor.
WILLIAM O’HARA is a consultant based in Canton, MI. He
earned a bachelor’s degree in mechanical engineering from
Hatfield Polytechnic in London.
TEAMS
Quality Tools,
Teamwork Lead
To a Boeing
System Redesign
by Nicole Adrian, contributing editor
T
he Boeing C-17 On-Board Inert Gas Generating
System (OBIGGS) II improvement project team
completely redesigned a system that prevents
fuel tanks from exploding if struck by enemy gunfire.
This project resulted in one of the strongest systems
on the C-17.
In 50 Words
Or Less
• A team from Boeing worked to fix an inert gas generating
system that previously needed constant repairs.
• Team members used several quality tools to identify
causes and find solutions.
• The outcome was a 7,400% increase in system reliability
and reduced initialization time.
Photo courtesy U.S. Air Force
The group was one of three teams to earn a silver
medal in the 2007 International Team Excellence
Competition, sponsored by ASQ’s Team and
Workplace Excellence Forum. The team presentations
are judged annually at ASQ’s World Conference on
Quality and Improvement.
While the previous system, OBIGGS I, success-
fully protected the fuel tanks, it required frequent
maintenance. The low system reliability caused
high repair costs, many labor hours and airplanes
that were not mission capable (see Figure 1, p. 38).
OBIGGS prevents the tanks from exploding by
injecting inert nitrogen gas into the space above
the fuel. These systems are found on C-17 military
cargo planes, which carry huge payloads—includ-
ing supplies and troops—over long distances.
The Air Force council that sets funding priori-
ties for projects like this rated OBIGGS reliabili-
ty improvement as the No. 1 priority for future
C-17 funding. The team realized that improving
the OBIGGS reliability would have more impact
on the airplane’s reliability than almost any
other system. From here, a team was created
and the process began.
The team that developed OBIGGS II—the name for
QUALITY PROGRESS I NOVEMBER 2007 I 43
TEAMS

the newest system—included more than 200 Boeing FIGURE 1 Reasons for Selecting
employees, 150 suppliers and 50 Air Force members. the Project
For this project, C-17 executives created a separate OBIGGS improvement projection vs. actual reliability
organization to perform as a single unit without
competing priorities. New facilities, with state-of-
the-art computer equipment and conferencing System objective
amenities, were constructed for the team’s use.
Projected improvement

Hours
Project leadership provided training so team mem- after incremental design Good
bers could enhance the system development. change implementation
Goal
Several OBIGGS I component design changes to Actual
improve reliability were identified during the first reliability
Improvement
few years after the C-17 became operational in 1995. projection
By 1999, all of those improvements had been incor-
Month
porated, and the OBIGGS reliability was still unsatis-
factory. At that point, a small team was formed to
brainstorm solutions and improvements, and to
quantify and document ideas, which were presented
to the Air Force. In 2003, the team received the Air

An Insider’s View
by Don Snow, OBIGGS II system architect and lead engineer

Keeping everyone on the large
team up to date and working together
was a challenge, but we scheduled
weekly coordination meetings with
each Boeing functional group, suppli-
er and customer.
Another key to communication
and teamwork was that executive
management moved everyone who
worked full time on the project to one
facility. This simplified communica-
tion among team members and pro-
moted a common vision of how each
person’s work contributed to the
overall project.
A particularly exciting time in the
project life cycle was during the relia-
bility demonstration. By that time we
had already delivered 12 airplanes
with the new OBIGGS II, and flight
tests had verified that the fuel tanks
were protected.
The demonstration lasted about
three months, and we monitored all
OBIGGS II maintenance that occurred
during that period. We held a confer-
ence call every Monday morning
with the Air Force maintainers at the
different C-17 bases to review any
jobs from the previous week. Our
excitement amplified as the weeks
went on, as it was increasingly clear
that our reliability targets were going
to be greatly exceeded.
When the project was nearing
completion, I was one of the team
members selected to document how
our team had applied ASQ team
excellence criteria during the project.
We presented our results at the
California Council of Excellence com-
petition and at the International Team
Excellence Competition at ASQ’s
World Conference on Quality and
Improvement.
In the two years since the first air-
plane was delivered with the new
system, we’ve monitored the
OBIGGS II reliability and found and
fixed a problem that would have lim-
ited the life of one of the key OBIGGS
II components. Our customer has
helped us expedite the design solu-
tion to minimize the impact, and
it is gratifying to have gained our
customer’s trust and continued
confidence.

44 I NOVEMBER 2007 I www.asq.org

Force’s approval to start the redesign, which was
conducted between 2003 and 2005.

Finding the Cause

The team used data, quality tools and concepts,
including a Pareto analysis and brainstorming, to
first select the project and then determine the root
causes of the problem (see Table 1).
Stakeholders were closely involved in the entire
process, especially in identifying the root causes and
project selection, because the project was customer
funded. Stakeholders included engineering groups,
support systems groups, Air Force customers and
BOEING TEAM MEMBERS: The OBIGGS II Boeing team members
suppliers.
who presented at the World Conference on Quality and Improvement
One of the most important tools the team used
included (back row, from left) Brent Theodore, systems engineer;
was maintenance data from the Air Force that pro-
John Watson, reliability engineer; Dan Ehlers, design manager; (front
vided the best source for identifying component
row, from left) Rick Morey, project manager; Don Snow, system
failures, because the records were generated by
architect and lead engineer; and Ben Canfield, senior manager.
pilots and maintenance crews at the time of failure.
From these records, Boeing also created a tool to
capture the time required to maintain each of the
aircraft systems.
Other methods used were: on what they had to do to fix the parts.
• Failure reporting and corrective action system • Tracking charts and in-service evaluations to
(FRACAS) to correct, sort, analyze and store monitor performance as the team implemented
data from Air Force records. fixes to the system’s components.
• Government on-line data (GOLD) from the • Step-by-step detailed analysis to examine each
Boeing database to track each component failure.
returned to the supplier for repair. The database • Pareto analysis to help the team focus efforts on
includes details received from the Air Force on the driving components for maximum benefit.
the reason for removal and from the suppliers • Brainstorming with stakeholders and subject

TABLE 1 Quality Tools in On-Board Inert Gas Generating System (OBIGGS) II Project

Method/ tool
Air Force maintenance data
FRACAS (Boeing database)
GOLD (Boeing database)
Tracking charts and in-service
evaluations
Step-by-step detailed analysis
Pareto analysis
Brainstorming
How it was used Who used it Why it was used
Collect maintenance activity of OBIGGS I Reliability engineer To have best source of field failure data
Store data from Air Force for Boeing analysis Reliability engineer To use Boeing C-17’s closed loop system
for tracking corrective actions
Collect data on component repairs Reliability and design To obtain C-17 source of supplier repair
engineers induction data
Provide weekly representation of field activity Reliability engineer To track performance of OBIGGS
Analyze each piece of data Reliability and design To determine root causes of
engineers individual failures
Rank components and failure modes Reliability, design To identify failure drivers within
engineers and suppliers the system
Provide free flow of ideas All stakeholders To formulate solutions

QUALITY PROGRESS I NOVEMBER 2007 I 45

TEAMS
matter experts to help identify root causes.
From there, the team established a list of possible
root causes for the frequent maintenance. Team
members discussed which components had inherent
design weaknesses, where maintenance malprac-
tices were occurring, why some components would
fail again shortly after being repaired and why some
trouble shooting procedures were lacking.
Additionally, the team interviewed Air Force
pilots and maintainers to fully understand what
maintenance problems were occurring. This step ver-
ified the team was on the right track. The team also
used suppliers’ repair databases to obtain detailed
information about the specific cause of each failure.
Lastly, the team used failure modes effects analysis
(FMEA) during the search for the final root cause.
The data identified all the components in the sys-
tem that failed, which were subsequently removed.
The team then studied what, when and where the
components failed, on which aircraft and what
parts were turned in for repairs.
Team members found that not only were the
system’s components failing far too often, but it
also took to long to initialize the system and
placed unnecessary stress on other systems. The
system’s drain on maintenance—both in time and
money—was significant.
The team discovered it was generally successful
in fixing the original root causes of the component
failures. However, team members also found that
when the parts lasted longer, new failure modes
A TEAM EFFORT: The entire OBIGGS II team, pictured here, included more than 200
Boeing employees, 150 suppliers and 50 U.S. Air Force members.
46 I NOVEMBER 2007 I www.asq.org
appeared and prevented the breakthrough reliabili-
ty improvement expected.
Digging Into the Data
After working through and discussing the possi-
ble root causes, the team dug deeper into the data.
Suppliers performed detailed analyses of what
failed on each of their returned components and
formulated ideas for solutions. The team involved
secondary suppliers for more detailed analysis of
how pieces were failing and had them conduct fur-
ther testing.
The team found that even after implementing
multiple component design changes, the system
was not achieving the reliability improvement
expected. Additionally, the team realized that
because the system was so complex, the reliability
goal it was shooting for would always be per-
ceived as being too low, and the Air Force would
be unhappy with its performance. Furthermore,
after conducting a FMEA of the entire OBIGGS I
using detailed analysis results, the team conclud-
ed there were far too many failure modes.
As the final root cause, the team concluded that
OBIGGS I was just too complex to fix. Even if the
reliability problem could be fixed, the time it took
to initialize the system could not be reduced due to
its design methodology. The team decided to com-
pletely redesign the system.
With the redesign, the team hoped to improve the
system’s reliability—which the Air Force deemed as
the main priority—and reduce ini-
tialization time (see Figure 2). The
team also hoped to achieve excellent
award ratings from the Air Force,
which evaluates each project it funds
semiannually. Those ratings, in turn,
determine an incentive payment to
Boeing. Additional benefits of a
redesigned system would include
reduced repair costs, less mainte-
nance labor and improvement to the
aircraft mission capable rate.
Developing the Solution
The team used a variety of quali-
ty tools to develop a possible solu-
tion for the redesign, including:
• Fault tree analysis.
 • Brainstorming. FIGURE 2 Affected Organizational Goals/Performance
• Benchmarking suppliers. Measures and Strategies
Team members analyzed four possible
solutions and defined the architecture and Achieve aggressive Strengthen Relentlessly Organizational
required performance for each. The efforts improvements in stakeholder improve and strategies
safety, quality, relationships integrate process
resulted in a set of components for each
schedule and cost
solution that would be used in further
detailed analysis.
Improve satisfaction
Also, component size and weight were
index Organizational
analyzed to meet baseline performance for
goals
each option. Component data for each sys- Improve mission Capture incentive
tem were totaled to use in comparing the capable rate award fee
options, and the team computed a system
level reliability for each solution.
Component costs were computed and Key performance Receive excellent Project
measures: award fee ratings performance
then totaled for each solution. The team then
• Improve reliability from customer measures
rated how well each option satisfied the • Reduce initialization
selection criteria received from the customer. time
Design criteria were used to evaluate each
of the possible solutions, and customers Project strategies:
were surveyed to ensure the team had cap- • Enhance customer satisfaction by developing a simpler, more reliable OBIGGS
tured and ranked the critical system level • Develop and implement innovative methods and processes to maximize return
on investment
requirements. The team also created analy-
sis tools to determine how much nitrogen
would be needed to initialize the tanks for
each architecture. program. These analyses confirmed the trade study
A quality function deployment (QFD) analysis estimates.
defined the relationship between each design criteri- A project task plan was developed by all stake-
on and the system requirements. Then the design cri- holders and approved by the Air Force. It included
teria were weighted to correlate with the system a technical overview of the project and a high level
requirement weighting factors provided by the cus- team plan. The team plan identified key project
tomer. A trade study to select the final solution was milestones with target completion dates. It was fur-
conducted following the standard Boeing systems ther developed in the integrated master schedule
engineering practice for optimizing a balanced trade- and master plan.
off of requirements among various engineering
design alternatives. Making Changes
The team expanded to include representatives of The team’s final solution—which offered the
all stakeholders, and the QFD defined the weighting largest potential return on investment, even
factors for the different design criteria that aligned though the development cost was high—was to
with the customer weighted system requirements. completely redesign the OBIGGS with:
The team scored each possible solution against the • Continuous flow.
various design criteria, and the option with the • Permeable membrane air separation.
highest score was chosen as the final solution. • A boost compressor for rapid descents.
To validate completely redesigning the OBIGGS, • A bleed air supply from the environmental
the team used various methods to confirm the control system.
solution selected. The efforts included cost as an • Open architecture control.
independent variable analysis, weight analysis, • No fuel scrubbing.
computational fluid dynamics analysis, life cost Several effective procedure and system changes
cycle analysis and an OBIGGS mission analysis that were developed to implement OBIGGS II were

QUALITY PROGRESS I NOVEMBER 2007 I 47

TEAMS
sustained throughout the project, including draw-
ing quality inspection, production tag-up database
and reliability evaluation plan. Some have even
been adopted by other projects.
The teams used both existing and new systems to
measure and sustain project results. Project specific
reports and metrics were developed to measure
parameters for such activities as engineering draw-
ing creation, technical manual creation and part
procurement.
Performance and schedule tools were integrated
into one common instrument, which the stakehold-
ers updated weekly. It was used to manage the
project and provide reports to executive leadership
and the customer.
Exceeding Expectations
After several planes with OBIGGS II were deliev-
ered, a new reliability evaluation verified that relia-
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48 I NOVEMBER 2007 I www.asq.org
bility targets were met. Each week, the team
reviewed the actual reliability data for the in-ser-
vice airplanes.
The tangible and intangible results greatly
exceeded everyone’s expectations for the system.
They were:
• Increased system reliability by 7,400%.
• Reduced initialization time by a factor of 11.
• Reduced weight by 517 pounds, allowing for
increased cargo capacity.
• A 20% system and 3:1 life cycle cost savings.
• Improved customer satisfaction and strength-
ened stakeholder relationships.
• Becoming the industry leader in inerting sys-
tem design.
• Incorporation of an open architecture design
that reduced the cost of future improvements.
• Achievement of aggressive financial improve-
ment by reducing logistic and production
costs, and of earning of excellent
ratings during all award fee periods.
The team regularly communi-
cated the results with stakehold-
ers through meetings, reviews
and flight test reports. At the end,
the team met cost, schedule and
performance targets, and the total
cost of the project came in 0.5%
under budget.
The open communication
stressed throughout the process
was key to the project’s success.
Additionally, team member com-
mitment and ownership promoted
the common goal of delivering an
OBIGGS to the customer that
would meet or exceed the required
performance measures. The result?
A sense of unity and teamwork
that enabled members to set new
benchmarks for project success.
NOTE
Look for case studies on the other
three winning projects from the 2007
International Team Excellence
Competition in past and future issues
of Quality Progress.
Professional Networking
Through Each One Reach One
Jim Smith
Joined ASQ in 1979
Fellow Member
Active participant in the Each One Reach One referral program
Dianne Smith
“Over the years, I have recruited more than 400 people, from several areas Joined ASQ in 2006
around the United States, and continue to stay in touch with many of them. Recruited by Jim Smith
At the end of the day, quality needs to be personal.”

A very important aspect of growing as a professional is the chance to build relationships with your
peers. ASQ provides its members with a great opportunity with the Each One Reach One member
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QUALITY IN THE
FIRST PERSON
One Person’s Quality Journey
Begins in the Insurance Industry
M
y quality journey began when
I discovered the Chartered
Property Casualty Underwriters
(CPCU) designation and CPCU Society.
At the time, I was a claims adjuster
trainee, and when a friend suggested I
consider the CPCU program, I was
eager to learn as much as possible.
This advice proved to be invaluable—
I am proud to say I earned my designa-
tion in 1997. Over the course of my
career, I have been a claims adjuster,
claims supervisor and litigation
manager.
After nearly 16 years in the claims
arena, I joined Goldberg Segalla LLP, a
national best practices law firm, as the
director of best practice compliance and
insurance industry liaison.
I attribute a great deal of my career
success to the knowledge I developed
studying for my designation and par-
ticipating in the CPCU. I have had the
opportunity to strengthen my quality
management and leadership skills, and
meet many great people.
The CPCU Society
The CPCU Society is a community of
insurance professionals who promote
excellence through ethical behavior
and continuing education. The soci-
ety’s mission is to “meet the career
development needs of a diverse mem-
bership of professionals who have
earned the CPCU designation, so that
they may serve others in a competent
and ethical manner.”
Today, the CPCU designation is one
of the most valued and recognized des-
ignations in the insurance industry.
There are nearly 28,000 members in the
society, as well as 151 local CPCU chap-
ters and 14 interest sections.
Each section has a committee that
produces educational programs, pub-
lishes newsletters and maintains a
website. The total quality (TQ) interest
section serves its members by assisting
them in improving, excelling and
becoming leaders in their business per-
formance and promoting total quality
management (TQM).
When I began my career at Goldberg
Segalla, I was eager to enhance my
skills in process and TQM. Although I
was familiar with the basic principles
of quality, this was the first time I was
in a role solely dedicated to quality
management and compliance. I volun-
teered for CPCU Society national ser-
Involvement in
a professional
organization opens
doors to new ideas,
initiatives.
vice and became a member of the TQ
committee. I also was inspired to com-
plete the associate in insurance ser-
vices (AIS) program.
I gained incredible insight from com-
pleting the AIS25 course and was sur-
prised by how quickly I was able to
apply that knowledge to develop a
quality management system (QMS) at
the firm.
Customer Orientation
The definition of quality can range
from conformance to requirements, and
includes achieving superior results and
producing products or services with
high specifications. Simply stated, qual-
ity starts and ends with the customer.
Prior to joining Goldberg Segalla, I
was the customer. The focus on cus-
tomer orientation led me to evaluate
my past experiences with defense
counsel and consider what they could
have done to make my job easier. It was
important that they understood my
needs and goals, and that they worked
with me to accomplish them.
I immediately set out to become thor-
oughly familiar with the guidelines of
our clients, introduce myself to them,
ask questions, secure constructive feed-
back, and understand their needs and
expectations. The course materials
helped me generate ideas to enhance
how we proactively listen to the voice
of our customers.
by Laura M. Kelly
Process Management and
Improvement
Next, I considered how we could
achieve guideline compliance for mul-
tiple customers with very different
needs and expectations. It was appar-
ent that to be successful we needed to
have a process to objectively measure
and document our results, assist staff
in understanding and fulfilling each
customer’s requirements, and continu-
ally improve efficiency and effective-
ness. Therefore, we needed to take a
process approach to managing our
compliance efforts.
Process ownership requires respon-
sibility for a plan’s design, operation
and improvement. We already had the
consensus of management, and there
was a strong commitment to improve
and deliver superior service to our
customers. The creation of my posi-
tion—devoted to compliance and
quality—demonstrated that commit-
ment.
Process planning refers to document-
ing, defining and understanding each
step of a process. During this phase, I
explored what we had done in the
past, what processes or methods were
already in place, how work flowed
through the firm and what each per-
son’s role involved. I encouraged oth-
ers to share their thoughts and ideas
with me along the way.
Process control ensures outputs are
predictable and consistent with cus-
tomer expectations. We developed a
process that allows us to monitor and
ensure the resolution of every matter
fulfills each customer’s requirements
from the time it is referred to the firm
until the matter is closed. We also
devised tools to assist in the identifica-
tion of various clients’ guideline
requirements and created firmwide
protocols to provide guidance and
make expectations clear.
Process measurement refers to map-
ping the performance attributes of the
process and establishing criteria for
evaluating them. Our file monitoring
process allows us to continuously mea-
sure and monitor the results of achiev-
QUALITY PROGRESS I NOVEMBER 2007 I 51
QUALITY IN THE
FIRST PERSON

ing compliance with guidelines.
Process improvement involves
increasing the effectiveness of the
process. Although we now have a
process established, we must continue
to enhance it. We recognize that we
might find more effective ways to
achieve desired outputs, as a cus-
tomer’s expectations might change and
issues or problems might develop that
will require us to revisit our QMS in the
future.
Employee Involvement
When an employee is enthusiastic,
energetic and cares about what he or
she does, it is obvious to the customer.
Our firm has a clearly communicated
mission, vision and values. Employees
are encouraged to develop and use
their full potential and work together
as a team to support the firm’s goals
and objectives. The firm’s leaders listen
to employee and client suggestions
and take action based on feedback.
We have conducted firmwide meet-
ings to discuss our goals, review the
processes we have established to
achieve them and encourage commu-
nication in an open forum for employ-
ees. Now that we have a process in
place, we must continue to monitor it,
test it and find ways to continuously
improve it.
We take our best practices commit-
ment seriously, and we truly care
about the way our internal and exter-
nal customers are treated. Ultimately,
it is recognized that the manner in
which employees are treated and
clients are serviced throughout the liti-
gation process is just as significant as
the ultimate outcome of the matter we
are handling.
Quite often, it is easy to miss some of
the elements while creating or manag-
ing a process and to instead concen-
trate on fulfilling internal requirements,
ultimately losing focus on the cus-
tomer. However, without the customer
there would be no reason for an organi-
zation to exist.
Today I continue on my quality jour-
ney. Wherever my journey might take
me, I will continue to apply everything
I am learning to bring value to my
firm, the CPCU Society and ASQ.
LAURA M. KELLY is the
director of best practice
compliance/insurance
industry liaison at
Goldberg Segalla LLP, a
law firm with offices in
New York, New Jersey
and Pennsylvania. A
member of ASQ, Kelly is a certified quality
improvement associate and moderates the
Insurance Industry network discussion board.
She has also earned the associate in claims and
associate in insurance services designations.
Please
comment
If you would like to comment on this
article, please post your remarks on
the Quality Progress Discussion
Board at www.asq.org, or e-mail
them to editor@asq.org.

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52 I NOVEMBER 2007 I www.asq.org

 MEASURE
FOR MEASURE
Calibration—The Good, the Bad
And the Ugly
here are good, bad and ugly
T calibration programs. Before
diving headfirst into particu-
lars, let’s define what calibration is
and what it is not.
Essentially, calibration is the compar-
ison between test equipment with an
unknown uncertainty to a standard
with a known uncertainty.
Calibration is the comparison of a
piece of test equipment and a standard,
regardless of whether the standard is:
• Kept by National Institute of
Standards and Technology (NIST).
• Used as the reference standard by a
third party calibration lab.
• Used as the working standard
everyday by your local calibration
technicians.
Calibration is a comparison. You
need something to calibrate and a
standard to compare it against. It has
nothing to do with adjusting, repair-
ing, aligning, zeroing or standardiz-
ing. All of these activities can be
incorporated into the process at some
point, depending on what the item is,
how it is used and, in some cases, at
what level it is being calibrated.
I’ve had ISO 9001 auditors tell me
you cannot calibrate a thermometer
because you cannot adjust it. Naturally,
I was obligated to inform them of the
error of their ways.
Calibration Everywhere?
There are some statements calibra-
tion technicians might make to
describe how their jobs affect our
quality of life. They might say:
• The equipment I calibrate on a
daily basis helps catch killers and
rapists all across America.
• My work was instrumental in
helping to free the innocent from
prison.
• The accuracy of my work helps
airlines reduce accidents and
mishaps.
• The highways and byways are
safer because of the due diligence
of our calibration program in
automotive manufacturing.
• The number of people helped by
the medications we manufacture
by Jay L. Bucher
using calibrated systems and mea-
surements is incalculable.
• There are discoveries of more drugs
and cures for the incurable than
ever before, in part because of the
repeatable readings and accuracy of
our calibrated test equipment.
How is any of this possible? Quality
A quality calibration
system is the foundation
for building safe, reliable
products.
calibration systems are the foundation
for improving R&D, production and
quality assurance arenas through
accurate, reliable and traceable calibra-
tions of test equipment. If quality cali-
bration is not important, then why is it
a requirement in industry, government
and the private sector?
Calibration can be, and usually is, a
critical component in any manufactur-
ing company. But, like any other part
of a quality system, calibration relies
on truth—collecting the right informa-
tion, recording it correctly and deter-
mining whether the test equipment is
in or out of tolerance.
The people performing the calibra-
tion must have integrity in all aspects
of their job performance. If they fudge
the numbers, there might be several
consequences such as:
• Bad product is produced, and cus-
tomers waste their money.
• Bad product is produced, and cus-
tomers are sickened or die.
• Bad product is produced, and a
company’s good reputation be-
comes irreparably damaged,
resulting in employee layoffs.
Does this sound far-fetched or the
figment of an overactive imagination?
Not really, especially when public
safety is part of any Food and Drug
Administration inspection.
When producing drugs, medical
devices or any other product that
impacts people’s safety, it is impera-
tive that standard operating proce-
dures are followed and the truth
about measurement and its results be
correctly recorded.
A quality product starts in the mind
of the R&D scientist and ends when a
finished product is ready for purchase
by the public. There are thousands of
steps along the way that could impact
the quality, quantity, size or value of
that product. All it takes is one untruth
to impact the final product.
One simple “Ah, this isn’t that
important” attitude from a calibration
technician (or any other person in the
manufacturing process) can easily
impact the final result.
Good, Bad and Ugly
So what is the difference between
good, bad and ugly calibration sys-
tems? Here are some examples of each
to clear up any misunderstanding.
Good calibration system: The cali-
bration technicians are honest and ethi-
cal in their endeavors. The technicians:
• Use written calibration procedures
that fall under a quality documen-
tation system.
• Record what the standard reads, as
well as both the “as found” and “as
left” readings from the unit under
calibration (UUC) when appropriate.
• Compare the results and act on the
difference.
When the UUC is found to be out of
tolerance, there should be procedures
in place to inform the user or cus-
tomer, as well as a written process for
evaluating whether the product or
process was impacted by the test
equipment found to be out of toler-
ance. This is only the tip of the iceberg
of any quality calibration program.
At a minimum, a good calibration sys-
tem will also have the following in place:
• Traceability documentation.
• Proper calibration labels.
• Uncertainty budgets.
• Calibration interval procedures.
• Good scheduling practices.
• Environmental conditions and
parameters.
• Calibration management software.
• Documented training procedures.
• Continuous process improvements.
QUALITY PROGRESS I NOVEMBER 2007 I 53
 MEASURE
FOR MEASURE
Bad calibration system: Most of the
parts are missing or misunderstood.
Calibration records are either nonexis-
tent or don’t contain the required items
to make them usable or viable. There is
no uncertainty budget or traceability
paper trail to speak of. The only reason
the company is not written up by an
auditor might be because the audit is a
“paperwork only” process, not a true
inspection against a standard.
An FDA inspector would write up a
bad calibration system without hesita-
tion. It’s very easy to identify. The
usual result is unreliable test equip-
ment that cannot produce accurate
measurements. The company is not
required to adhere to any standard or
regulation and cannot compare itself
to its competition.
Ugly calibration system: This is a
horse of a different color. It has most,
if not all, of the elements found in a
good calibration system. The major
difference comes in the lack of integri-
ty and honesty of the calibration tech-
nicians, their supervisor and upper
management. Other characteristics of
an ugly system include:
• Numbers are fudged on the cali-
bration record and are difficult to
find during an audit.
• Calibration due dates are extended
when the backlog starts to rise,
and overdue calibrations are unac-
ceptable (test equipment doesn’t
really go bad over time, does it?).
• Test equipment is said to be cali-
brated when in fact it isn’t.
By far, this last situation is the most
common characteristic and is commonly
referred to as “lick ’em and stick ’em,”
“hot stamping” or “turn and burn.”
These phrases denote placing a calibra-
tion label on equipment that has not
been correctly, competently or actually
calibrated. Or the equipment is out of
tolerance, and the technician doesn’t
want to follow the processes set in place.
Predictably, the company with an
ugly calibration system produces inferi-
or products but gets away with it by
displaying ISO 9001 or current good
manufacturing practice labels on the
products. Eventually, the customer base
goes away because of unreliable, nonre-
peatable and substandard products. It is
hoped that none of the company’s
products cause illness or death.
It’s important to note that the vast
majority of calibration technicians,
54 I NOVEMBER 2007 I www.asq.org
Defining Calibration
The following are primary and secondary definitions of the term “cali-
bration,” according to The Quality Calibration Handbook:1
Calibration is a term that has many different but similar definitions. It
is the process of verifying the capability and performance of an item of
measuring and test equipment compared to traceable measurement
standards.
Calibration is performed with the item being calibrated in its normal
operating configuration—as the normal operator would use it. The cali-
bration process uses traceable external stimuli, measurement standards
or artifacts as needed to verify the performance. Calibration provides
assurance that the instrument is capable of making measurements to its
performance specification when it is correctly used.
The result of a calibration is a determination of the performance quali-
ty of the instrument with respect to the desired specifications. This might
be in the form of making pass/fail decisions, determining or assigning
one or more values, or determining one or more corrections.
The calibration process consists of comparing test equipment with spec-
ified tolerances of unverified accuracy, to a measurement system or device
of specified capability and known uncertainty, to detect, report or minimize
by adjustment any deviations from the tolerance limits or any other varia-
tion in the accuracy of the instrument being compared. Calibration is per-
formed according to a specified documented calibration procedure, under
a set of specified and controlled measurement conditions, and with a spec-
ified and controlled measurement system.
Many manufacturers, auditors and quality assurance inspectors incor-
rectly use the term calibration to refer to the process of alignment or
adjustment of an item that is either newly manufactured, known to be out
of tolerance, or otherwise in an indeterminate state. Many calibration pro-
cedures in manufacturers’ manuals are actually factory alignment proce-
dures that only need to be performed if a unit under calibration is in an
indeterminate state because it is being manufactured, is known to be out of
tolerance, or has been repaired. When used this way, calibration means the
same as alignment or adjustments, which are repair activities and excluded
from the metrological definition of calibration.
REFERENCE
1. Jay Bucher, The Quality Calibration Handbook, ASQ Quality Press, 2007.
supervisors and upper management JAY L. BUCHER is pres-
with whom I have worked have had ident of Bucherview
the highest integrity. Their ethics are Metrology Services, a
beyond reproach, and a quality product consulting company spe-
is always on their minds. As with most cializing in quality cali-
things in life, the few bad apples get the bration systems. He is
attention. I would like to acknowledge co-author and editor of
the good apples here. The Metrology Hand-
book (ASQ Quality
The diligent calibration technician,
Press, 2004), and author of The Quality Cal-
working under a quality calibration sys- ibration Handbook (ASQ Quality Press,
tem, no matter whether private industry 2007) and Paperless Records—Designing
or government, continually produces a and Creating Your Own Electronic Forms
quality product in a timely manner. (Bucherview Metrology Services, 2007). He is
Without their due diligence, our the treasurer of the ASQ Measurement Quality
world would be a far worse place in Division. Bucher is a senior member of ASQ
which to live. and a certified calibration technician.
CAREER
CORNER
Turning the Tables: Six Questions
To Ask Your Interviewer
ime is at a premium when you’re
T interviewing for a new job. You
should expect the hiring organi-
zation to invest considerable time siz-
ing you up. But you might seek or be
given the opportunity to ask your
own questions. This is your chance to
interview the organization.
What you should ask will depend
partly on the nature of the job. In the
course of my own career, six questions
have proven helpful regardless of the
job. Here’s what to ask:
1. Is this a newly created position?
A new position probably means you
will not have to compete with some-
one else’s legacy.
If you’re looking for the best chance
to leave a new mark on an organiza-
tion, an affirmative answer to this
question will pique your interest.
This is particularly true in the quality
field, where success depends on an
organization’s willingness to change.
Consider the creation of a new position
in the quality function a positive sign.
However, the roles, expectations
and standards for a newly created
position might not be as well defined
as for an existing one.
Make sure you feel comfortable tak-
ing the initiative to define what the
roles and expectations should be. The
opportunity for stumbles could be
higher, so your moves need to be con-
sidered more carefully.
2. Was the predecessor promoted,
or did that person leave? Learning
the predecessor was promoted should
encourage you to probe further into
the history of the job.
• Have promotions been common?
• Is promotion within the organiza-
tion the rule or the exception?
There are many good reasons peo-
ple leave an organization—a spouse’s
relocation, to be closer to family or a
change of interest.
If you learn the person left but get
less than a straight answer about the
reason, your skepticism about the job
and the organization should increase.
3. Who are the other people in the
work group, and what are their
by Joe Conklin
roles? A quick and complete answer
to this question speaks well of how
the organization is structured.
When considering a new position,
Preventive action can
help you determine
whether a job is right
for you.
look for work groups that represent a
variety of age, experience and talent.
Having too few experienced people
slows down the process of finding
solutions. Too few new people could
rob the group of fresh ideas.
Before ending the interview, it’s a
good idea to note the names and
responsibilities of all the people you
would work with closely in the new job.
A big surprise of a new job is meet-
ing someone in your group you had
not been told about during the inter-
view. The surprise turns into a cruel
joke if you and your colleague suffer
clashes of style or personality.
4. How do you evaluate perfor-
mance? The answer to this question is
a good way to figure out how long
you’ll have to show results. You want
to be reasonably sure there’s enough
time to tackle the challenge for which
you are being considered.
If the new organization has a radi-
cally different evaluation system from
your current one, are you confident in
your ability to adjust quickly? Does
the system make sense for the organi-
zation’s stated goals?
If success depends on teamwork but
the rewards go only to individuals,
you could conclude the organization
has not thought through performance
evaluations sufficiently. If this critical
function is shortchanged, what about
the other key processes in the organi-
zation? Most important, does the sys-
tem as described seem fair?
5. How long has the position been
open? There are good reasons for a
job to be open for a while.
The demand for the particular type
of employee could exceed the supply.
The organization might have had to
reorganize to respond to market or
industry changes but still needs to fig-
ure out where the job fits into the new
scheme of things. Maybe it requires
such a rare combination of skills that
identifying appropriate candidates is
time consuming.
If the job has been left open for a
good reason, continue to consider it if
it interests you. However, if the orga-
nization can’t make up its mind about
what it wants, is inflexible in the stan-
dards it applies or seems more inter-
ested in finding a cheap hire instead
of the right one, think about market-
ing your skills elsewhere.
6. What are the one or two most
important things I should accom-
plish in the first six months? I find
this to be the best way to find out
whether the organization has done its
homework about what it is looking
for in a new hire. Organizations that
aren’t sure what they want seem to be
the hardest to please and normally are
not good ones for which to work.
Addressing how you would meet the
job’s goals for the first six months is a
great subject for a written or electronic
acknowledgment of the interview.
What’s most important is that you
have your own questions, ones that
might differ from mine. Interviewing
the organization allows you to employ
one of the most powerful quality
strategies ever devised—prevention.
The shortest route to the best job is
avoiding the second best ones
through the right questions.
JOSEPH D. CONKLIN
is a mathematical statis-
tician at the U.S.
Department of Energy
in Washington, DC. He
earned a master’s degree
in statistics from
Virginia Tech and is a
senior member of ASQ.
Conklin is also an ASQ certified quality man-
ager, quality engineer, quality auditor and reli-
ability engineer.
QUALITY PROGRESS I NOVEMBER 2007 I 55
STANDARDS
OUTLOOK
Auto Industry Drives to Improve Healthcare
by R. Dan Reid
he U.S. auto industry has been
T challenged by its need to com-
pete in a global marketplace
while burdened by steep healthcare
expenses for workers and retirees.
This fall, the Automotive Industry
Action Group (AIAG) released its new
hybrid healthcare standard, Business
Operating Systems (BOS): For Health-care
Organizations—Requirements for Process
Improvements to Achieve Excellence.
BOS was developed as an evolu-
tionary AIAG replacement for the
now expired ISO International
Workshop Agreement (IWA) 1, which
was solely based on ISO 9001.
BOS is based on the 2006 Malcolm
Baldrige National Quality Award per-
formance excellence criteria for health-
care, but it also includes ISO 9001
requirements. This is thought to be the
first such combination of these two
improvement models to occur in the
standards world.
In blending these two improvement
methods, the AIAG BOS standard pro-
vides both the basic requirements for a
functional quality system and the
requirements for a business system
that will drive performance excellence.
Why Baldrige?
The Baldrige criteria, which are
updated and published annually,
have resonated in the U.S. healthcare
sector. Through 2006, six healthcare
organizations have received the annu-
al award, first opened to the sector in
2002.
The Baldrige healthcare criteria are
written in a style and uses vocabulary
that is more familiar to the healthcare
audience than ISO 9001, which is an
international and generic quality man-
agement standard applicable to all
types of organizations. While applica-
ble to healthcare, ISO 9001 is not spe-
cific to healthcare. This presents
challenges for users of voluntary stan-
dards that are based on ISO 9001 but
aimed at the healthcare sector.
The AIAG BOS standard, with its
unique hybrid approach, has adopted
the best of both. It adds requirements
56 I NOVEMBER 2007 I www.asq.org
and guidance based on valuable expe-
rience from other economic sectors that
are also applicable but not specific to
healthcare. This experience includes the
use of techniques such as error-proof-
ing, inventory management, emer-
gency planning and risk management.
Making the Case
The quality of U.S. healthcare deliv-
ery services is improving but still has
AIAG’s new standard
combines Baldrige
criteria and ISO 9001.
a long way to go. Consider facts from
recent articles:
• Even though people in the United
States are living longer, the life
expectancy of Americans is now
lower than in 40 other countries,
including Japan, Jordan, Guam
and most European countries.1
• Studies indicate one of every five
admissions to American hospitals
will include some kind of error.2
The rate of wrong site, wrong
patient and wrong procedure
errors remains steady after years
of concerted efforts by hospitals
and the Joint Commission to
address the problems.3
• Studies estimate that 90,000
patients die each year because of
infections they catch while in hos-
pitals or other medical facilities.
Deadly germs gain entry through
surgical incisions and catheters
and are sometimes transmitted by
doctors and nurses who fail to
wash their hands.4
Pressure is mounting both for
providers and users of healthcare.
Several measures are set for a 2009
implementation. For example, the
Centers for Medicare and Medicaid
Services announced in August that by
late 2008 it will no longer reimburse
hospitals for conditions associated
with errors such as bedsores, in-hospi-
tal falls, objects left inside surgery
patients and certain types of infec-
tions. A Wall Street Journal blog said:
The government estimates its
direct savings at about $20 million a
year, and Medicare has said hospi-
tals can’t turn around and stick
patients with the tab. ... Other insur-
ers are likely to follow suit, and hos-
pitals may well do a better job for all
patients, not just those on Medicare.5
Organizations are also making signif-
icant changes. One Indianapolis com-
pany plans to charge employees more
for healthcare insurance in 2009 if they
allow health risks to go unchecked.
Others are likely to follow.
Sixty-two percent of 135 top execu-
tives responding to Pricewaterhouse-
Coopers’ May 1 Management Baro-
meter survey said their companies
should require employees who exhibit
unhealthy behaviors such as smoking
or overeating to pay a greater share of
their health benefit costs.6
These initiatives are expected to
have two major demands:
1. Users should become more dis-
criminating consumers of health-
care.
2. Healthcare organizations should
get into the continual improve-
ment fast lane.
BOS writers hope some healthcare
organizations will heed the advice
from the Institute of Medicine (IOM),
which several years ago recommend-
ed that healthcare organizations look
outside their sector to adopt what the
IOM called “engineering principles”
used in other industries to improve
quality.7
It’s the Culture, Stupid
These so-called engineering princi-
ples are really quality management
methods, and BOS is full of such tried
and tested principles to drive organi-
zational excellence.
Culture continues to be a big chal-
lenge to BOS adoption. Primary

healthcare delivery is a product of hun-
dreds of years of history. It evolved
around a craftsperson model based on
the needs of doctors in an era of low
technology. Physicians were viewed as
experts who were beyond making
errors. Not anymore.
The sector is now trying to morph
into a service industry focused on the
needs of patients in a high-tech era.8
Today, many people have experi-
enced or know somebody who has
experienced healthcare errors. The
problem of medical errors is now well
documented. So, healthcare organiza-
tions need to be re-engineered, and as
a sector they are going to need lots of
help.
ISO 9001’s Quality
Management Principles
Healthcare’s culture has made it
challenging to adopt the eight quality
management principles ISO 9001 iden-
tifies to lead organizations toward
improved performance excellence:9
1. Customer focus: One disconnect
inhibiting healthcare quality improve-
ment is that healthcare practitioners
use a unique vocabulary. They do not
widely use the word customer,
instead referring to the client, resident
of extended care facility or patient.
Standards developers have strug-
gled to address this variation by con-
solidating the terms into a generic
phrase such as “subject of care,” but
these phrases can be even more
ambiguous.
2. Leadership: The traditional hos-
pital organization consists of two sep-
arate leadership silos: the CEO for
hospital functions (the nursing staff or
the lab, for example) and medical staff
(credentialing and peer review, for
example). The only place they come
together is on the board of trustees,
which typically meets infrequently.10
While not specifying any particular
organization structure, the BOS stan-
dard focuses significant requirements
on leadership, including appointing a
person responsible for its implemen-
tation and maintenance, irrespective
FIGURE 1 Process Model
Verification
Inputs activities
Machinery and equipment
Manpower
Methods Process
Materials
Measurements
of other duties. This will ensure lead-
ership’s attention to the entire scope
of the business.
BOS can also provide the umbrella
system to incorporate healthcare
accreditation criteria and regulatory
requirements to ensure compliance all
the time, not just in advance of a peri-
odic audit.
3. Involvement of people: In the
past, hospitals had a rigid hierarchy
with well-defined silos where practi-
tioners in different silos had infrequent
interaction. Communication in the
operating room was muted.
The healthcare sector has recently
been taking a page from another high
risk service sector—aviation—by
teaching the principles of teamwork
with courses like Crew Resource
Management, which is required of air-
line pilots and included in the BOS
standard.
4. Process approach: Healthcare
practitioners also do not use the terms
nonconformance or nonconformity,
instead referring to adverse or sentinel
events. This is related to a challenge
with the process approach principle.
Healthcare practitioners do not
seem to view their work as a process,
with inputs, outputs and one or more
customers or downstream users of
their service. Fundamental quality
management science recognizes the
need for appropriate controls on the
quality of the inputs as well as con-
trols for the process itself and the out-
put (see Figure 1). The AIAG BOS
standard focuses on requirements for
process improvement and the metrics
needed to drive excellence.
5. Systems approach to manage-
ment: George Halvorson of the Kaiser
Foundation says:
We don’t really have a health-
Verification
activities
Outcomes
Feedback
care delivery system in this country
… we have an expensive plethora
of uncoordinated, unlinked, eco-
nomically segregated, operationally
limited microsystems, each inter-
acting in ways that too often create
suboptimal performance both for
the overall healthcare infrastructure
and for individual patients.11
According to David Nash, a
researcher into the causes of medical
errors, there is no simple solution.12
The BOS standard brings a number
of the processes required for excellence
into one place and uses a systems
approach for implementation and
maintenance. This provides organiza-
tions with a business management sys-
tem that is sustainable, providing for
integration of new technology, on-
boarding of new people, process design
and control, and other improvements.
6. Continual improvement: Even
though healthcare’s culture is hundreds
of years old, there is nothing to pre-
clude today’s practitioners from mak-
ing continual improvement. Certainly
the adoption of lean principles and Six
Sigma from industry, as well as imple-
mentation of electronic records, will
drive significant improvement.
7. Factual approach to decision
making: Several industries have deter-
mined failure mode effects analysis to
be an effective way to identify and
quantify risk. It is now gaining popu-
larity as a Joint Commission require-
ment and Institute for Healthcare
Improvement recommendation. BOS
also recommends this technique as a
way to manage risk.
Despite the initial cost, more organi-
zations are jumping on the IT band-
wagon. Healthcare investment in all
types of IT in 2006 was growing faster
as a percentage (nearly 5%) than in any
other field, and it is expected to be in a
QUALITY PROGRESS I NOVEMBER 2007 I 57
STANDARDS
OUTLOOK
strong growth mode through 2010.13
IT systems, such as electronic health
records and electronic physician order
entry, lead to fewer medication errors,
decreases in medication processing
time, reductions in problem medication
orders, reductions in duplicate testing,
improved turnaround time for diagno-
sis and treatment, and reduction in the
average length of patient stay.14
However, organizations should
have good business processes in place
first and then base their systems on
the business process rather than the
other way around. BOS provides con-
siderable help regarding the processes
a healthcare organization should have
in place to achieve excellence.
In addition to implementing new
forms of IT to drive improvement, the
concept of sharing patient health
information across multiple health-
care organizations in a region or state
is gaining strength.
Benefits of such sharing include
streamlined physicians’ work, facili-
tated research, better tracking of out-
breaks or epidemics, and reductions
in duplicate tests and unnecessary
medical procedures that translate into
higher costs.15
This sharing can be viewed as a form
of benchmarking—looking outside the
organization for information that can
be used for internal improvement
efforts addressed in the BOS standard.
8. Mutually beneficial supplier rela-
tionships: The healthcare industry’s
history of regulating itself does not go
far enough to protect patients.16 BOS is
written as a standard, which makes it a
document that is easily audited,
Questions About Standards
Send your general questions about quality and environmental man-
agement system standards and their derivatives to standardsques-
tions@asq.org. Include your daytime phone number and e-mail
address. The questions will be submitted to one of QP’s regular
“Standards Outlook” columnists. Look for answers to appear in
future issues of QP.
58 I NOVEMBER 2007 I www.asq.org
whether by internal or external audi-
tors or by second or third parties.
This means customers, payers and
others could require evidence of com-
pliance with the BOS requirements as
a condition of doing business or as a
preferred credential. Healthcare orga-
nizations, accreditation bodies and
trade associations could also use it as
a requirement or preferred credential
for their suppliers.
Healthcare Education and BOS
Julie Gerberding, director of the
Centers for Disease Control and
Prevention, recently stepped into the
healthcare reform debate with a call
for changing the way doctors, nurses,
veterinarians, pharmacists and den-
tists are educated.17
Not only are more schools needed,
Gerberding said, but these profession-
als also need to start their educations
together to foster cooperation and a
sense of common mission.
Use of standards like BOS needs to
be integrated into undergraduate col-
lege curricula. Business and quality
management science should incorpo-
rate lessons learned from industry.
Organizations such as AIAG and ASQ
should take proactive and leading
roles in an educational initiative
aimed at healthcare.
The easy work is now completed—
the BOS document is available from
AIAG (www.aiag.org). Now comes
the hard part—implementation. Think
about ways quality principles can
make a difference in this critical sector.
The life you save might be your own.
?
REFERENCES
1. “American Life Expectancy Longer Than
Ever,” www.cnn.com/2007/HEALTH/09/12/
life.expectancy.ap/index.html?section=cnn_
latest, Sept. 13, 2007.
2. “Expert Discusses Medical Errors,”
Telegraph Herald (Dubuque, IA), Aug. 1, 2007.
3. “Wrong Site Surgery Rates Hold Steady,”
Patient Safety Monitor, Aug. 17, 2007.
4. Stephen Smith, “Hospital Infection May
Cost $473M,” Boston Globe, Aug. 9, 2007.
5. “Medicare Won’t Pay Hospitals to Remedy
Flubs,” http://blogs.wsj.com/health/2007/08/
08/medicare-wont-pay-hospitals-to-remedy-flubs.
6. PricewaterhouseCoopers, Management
Barometer Survey, www.barometersurveys.
com/production/barsurv.nsf/barometer_
management, May 1, 2007.
7. Institute of Medicine, “Crossing the Quality
Chasm: A New Health System for the 21st Cen-
tury,” National Academy Press, 2001.
8. Martin Merry, M.D., “Healthcare’s Need for
Revolutionary Change,” Quality Progress,
September 2003.
9. ANSI/ISO/ASQ Q9000-2000 Quality Manage-
ment Systems—Fundamentals and Vocabulary, ASQ
Quality Press, 2000.
10. Martin Merry, M.D., “The Future of
Healthcare Quality,” ASQ Region 8 Health Care
Conference, Cleveland, April 10, 2003.
11. George Halvorson, “Healthcare Reform
Now—A Prescription for Change,” John Wiley
and Sons, http://healthcarereformnow.org/
docs/health_care_bklt.pdf.
12. “Expert Discusses Medical Errors,” see ref-
erence 2.
13. John Buell, “Flexing Their IT Muscles,”
Healthcare Executive, September/October 2007, p.
16.
14. Ibid, p. 19.
15. Jessica Squazzo, “Health Data Exchange on
the Rise,” Healthcare Executive, September/
October 2007, pp. 8-14.
16. “Self-Regulation Doesn’t Work in Health-
care,” Patient Safety Monitor, Aug. 17, 2007.
17. Maggie Fox, “Start From Ground Up to Fix
Health Care: CDC Head,” Reuters, July 14, 2007.
R. DAN REID, an ASQ
fellow and certified quali-
ty engineer, is a purchas-
ing manager at General
Motors Powertrain. He
is co-author of the three
editions of QS-9000 and
ISO/TS 16949; the
Chrysler, Ford, GM
Advanced Product Quality Planning With
Control Plan; Production Part Approval
Process and Potential Failure Modes and
Effects Analysis manuals; ISO 9001:2000;
and ISO IWA 1.
Please
comment
If you would like to comment on this
article, please post your remarks on
the Quality Progress Discussion
Board at www.asq.org, or e-mail
them to editor@asq.org.
 QP
TOOLBOX
Temperature Sensor
Housed in Potted Metal
Spectrum Sensors and Controls’ snap-
in temperature sensor with a clip design
allows the sensor to monitor air tempera-
ture within an enclosure. The sensor’s
response thermistor element is integrated
into a potted metal housing. It can be
snapped into a 0.30 in. diameter predrilled
hole in sheet metal.
This keeps the sensor off the sheet metal
while the plastic molded body—with strain
relief—thermally separates the assembly
from the environment on the backside. The
sensor snaps into 14 to 18 gauge sheet
metal and comes with 10 ft. insulated leads.
Call: 814-834-1541; visit: www.
atpsensor.com.
Turck Releases
Molded M27 Connectors
Turck has released molded M27 con-
nectors. The 26 and 28 pin connectors can
be used to provide power and signals to
factory automation equipment in the
automotive, semiconductor and material
handling industries.
The M27 connectors are rated for 150V
and 5 amps, and can handle up to 18 AWG
(standard method of denoting wire diame-
ter) wires. The Turck line offers male,
female, straight and right angle connec-
tors of standard and custom lengths, as
well as pigtails or extensions.
Call: 800-544-7769; visit: www.turck.com.
inProcess Captures Steps in
Graphic and Text Formats
PMC Solutions’ process mapping soft-
ware inProcess version 3.2 gives compa-
nies a way to map, share and improve
processes. The software captures steps in
both graphic and text formats, allowing
associated documents, URLs, links and
audio and video files to be attached
directly to the process website.
Additional features include a cost and
durations display for each process step,
six report templates that allow users to fil-
ter, dissect and extract information as
needed and customized e-mail templates.
Call: 505-462-3190; visit: www.
pmcsolutions.com.
Coating Process Adds
Lubricity to Fasteners
The Nycote Nycrest masking process
from Nylok coats the root and flank of the
thread without coating the crest. This
Sheldon Manufacturing has added a large
capacity incubator shaker to its line.
process eliminates material buildup and
provides metal-to-metal contact between
the thread and collet. The Nycote Nycrest
coating offers protection against thread
contamination from electrodeposited
paints, primers, coatings and adhesion of
weld spatter.
The process adds lubricity to fasteners,
reduces torque versus tension scatter and
achieves known and repeatable clamp load.
The Nycote Nycrest coating process can be
used in industries such as agricultural,
automotive, appliance, electronics, machin-
ery, marine and outdoor power equipment.
Call: 586-786-0100; e-mail: sales@
nylok.com.
Artificial Perspiration
Mimics the Real Thing
Pickering Laboratories has released a
line of artificial perspiration for the envi-
ronmental, pharmaceutical and biochemi-
cal laboratory markets. Perspiration
mimics have been used by industries to
sweat test products such as textiles, dyes,
cosmetics, credit cards, shoe leather, jew-
elry and fingerprint forensic reagents.
Usually, a sweat mimic will vary with time
and industry.
Pickering Laboratories has developed a
standardized artificial eccrine perspiration
solution to make application tests repro-
ducible. The artificial perspiration con-
tains nine minerals, three metabolites and
20 amino acids. All components are nor-
malized to the same proportions found in
natural perspiration.
Call: 800-654-3330; visit: www.
pickeringlabs.com.
Shakers Designed for
▼
Large Scale Applications
Sheldon Manufacturing has expanded
its line of incubator shakers to include the
large capacity model SI9. The SI9 is
designed for large scale applications such
as cell aeration, metabolism studies, bac-
teriology and cell culturing.
The SI9 features an internal capacity of
9.5 cu. ft. and can accommodate up to 19
one liter flasks in a single load. The shak-
ing platform is included with purchase
and can be removed without any tools.
The shaker speed ranges from 30-400
RPMs. The units are stackable and the
door opens vertically. The SI9 is available
with or without refrigeration.
Call: 800-322-4897; e-mail: catherines@
shell.com.
VeriColor Spectro Measures
Color in Real-Time
X-Rite’s VeriColor Spectro instrument
for the process controls industry provides
color measurements for factory environ-
ments. The VeriColor Spectro provides
real-time or continuous data and mea-
sures colors at a distance of 10 cm from
the test surface. It measures the color of
products with varied textures and pro-
vides an immediate signal when a process
makes parts outside of specifications.
The VeriColor Spectro is designed for
industries such as printing, packaging,
photography, graphic design, video, auto-
motive, paints, plastics, textiles, dental
and medical.
Call: 616-776-3511; e-mail: gryczan@
seyferthpr.com.
AccuVision Light Modules
Resistant to Damage
The AccuVision internal backlit convey-
ors from Conveyor Technologies feature a
translucent, light-passing belt. The light
emitting diode (LED) system penetrates
the translucent belt with a uniform light
field illuminating the part shape for auto-
matic and manual visual inspection. The
LED light modules are resistant to dam-
age from shock or vibration.
The conveyors are available in a variety
of belt widths and light field choices to
meet the inspection needs of various
industries. The LED light modules are
available in both white and red light ver-
sions for improved compatibility with dig-
ital cameras.
Call: 513-248-0663; visit: www.
conveyortechltd.com. QP
QUALITY PROGRESS I NOVEMBER 2007 I 59
ASQ Sustaining and Organizational Members
These organizations have pledged their commitment to quality by becoming ASQ Sustaining or Organizational
members. Learn more about these membership levels, and the benefits, by visiting www.asq.org/membership.

Organizational Members Analogic Corp. Brunk Industries Credit Suisse, APAC

Abbott Andersen Corporation
Alcoa Angio Dynamics
Boeing Antares Management Solutions
Cummins Apple Inc.
DuPont Appleton
Hewlett-Packard Arcelik A.S. Eskisehir Compressor
Plant
L-3 Communications
Arcor SAIC
Lockheed Martin
Arctic Cat Inc.
Raytheon
Argus Health Systems Inc.
Sun Microsystems
Army Continuing Education System
Asco Valve Manufacturing
Sustaining Members AssurX Inc.
2AM Group LLC Atlas Copco Tools and Assembly
3M Company Atomic Energy of Canada Ltd.
AAI Corporation Auto Club Insurance Association
ABB Xiamen Switchgear Co., Ltd. Avid Ratings Co.
Avnet Technology Solutions
AFLAC
BD Biosciences
AFPSL/Bionetics
BD Diagnostic-Accu-Glass
AGCO Hesston Operations
BD Diagnostics
AIB International
BJC HealthCare
AIB-Vincotte USA Inc.
BSI Management Systems
AMC, Inc.
BWX Technologies, Inc.
AQS Management Systems
Banco Central de Costa Rica
ASAIE
BankMuscat
ASC Process Systems
Barr Associates Inc.
ASI DataMyte
Barr Systems, Inc.
Absolute Technologies, Inc.
Bartush-Schnitzius Foods Co.
Accellent
Battelle Memorial Institute ESH & Q
Accreditation Council of Trinidad &
Baxter Healthcare of Puerto Rico
Tobago,The
Accurate Laboratories Beacon Converters, Inc.
Aditya Birla Management BeautiControl, Inc.
Corporation Ltd. Bechtel SAIC Co., LLC
Advanced Acoustic Concepts Becton Dickinson Critical Care
Systems
Aeronautical Systems, Inc.
Bendix CVS
AeroVironment, Inc.
Bentley Systems Inc.
Affinia Canada Corp.
Best Buy Co. Inc.
Ahresty Wilmington Corporation
Bharat Electronics Limited
Albridge Solutions
Bibb and Associates Inc.
Alcan Packaging
Bimba Manufacturing Co.
Alcan Packaging Medical Flexibles
Americas BioReliance Corporation
Alcon Laboratories, Inc. BlueCross BlueShield of Florida
Allcast, Inc. Blue Water Automotive Systems, Inc.
Alliant Techsystems Bombardier Aerospace
Allied Technology Group Inc. Booz Allen Hamilton
Altman Browning and Company Bose Corporation
American Airlines Boston Scientific Corporation
American Family Insurance Botswana Bureau of Standards
American Society of Radiologic Botswana National Productivity
Technologists Bowles Fluidics Corp.
American Technical Ceramics Boyce and Bynum Pathology Labs
Amtech LLC Briggs & Stratton
Ana G. Mendez University System Brigham Young University
Bulk Molding Compounds Credit Suisse, EMEA
Bunn-O-Matic Corporation CryoTech Inc.
CGI Technologies and Solutions Inc. Czech Society for Quality
CIBA Vision Corporation D' Addario & Company Inc.
CONEXIS DB Operations International
CSA Group DQS German American Registrar
CSA, Ltd. DST Output - East Operations Center
California Service Center Dallas County Community College
California University of Pennsylvania District
Cardinal Health Jacksonville Facility Dayco (Mark IV Automotive)
Cardinal Health Medical Products Dayton-Granger, Inc.
Manufacturing Dearborn Precision Tubular Products,
Cargill Inc. Inc.
Casa Cuevo S.A. De C.V. Decatur Memorial Hospital
Caterpillar, Inc. Decoma Nascote Industries
Caterpillar Inc. DTF Deere & Company
Caterpillar, Inc. GEC Delaware Department of Natural
Caterpillar, Inc. MEC Resources
Caterpillar Logistics Inc. Dell WWP ASEQ
Celestica International Inc. Department of Housing & Community
Cementos Lima S.A. Development
Center Quality Office Department of National Defence,
Canada
Cerveceria Polar Los Cortijos C.A.
Detroit Medical Center
Cetec-ISC Ltd.
Dey L.P.
CheckFree Corporation
Digene Corporation
Checkpoint Caribbean Ltd.
Display Pack Inc.
Chevron Oronite
Dominos Inc.
Children's Hospital of
Doncasters Inc.
Philadelphia,The
Dutch Space B.V.
Chiquita Brands International
Christian Brothers University DynMcDermott Petroleum Operations
Co.
Cigna Government Services
Dynacraft
Cincinnati Precision Instruments, Inc.
EMCOR Corporation
Cinram Inc.
EMTEQ
Cirrus Design Corp.
ESC Lille
Citizenship and Immigration Services
Eastern Research Group Inc.
Clairson Plastics
Eastman Chemical Company
Click Bond Inc.
East Penn Manufacturing Co., Inc.
Coherent Inc.
Coloplast Manufacturing US LLC Eaton Corporation
Colorado Springs Utilities Eaton Ltda. Transmission Division
Community Health Plan of Edwards Lifesciences
Washington Eli Lilly & Co.
Companhia Siderurgica Paulista El Paso Community College
Compuware Corporation El Tronic Precision, Inc.
ConAgra Foods Emerson Network Power Co., Ltd.
Conestoga Wood Specialties Corp. Energy & Environmental Res. Ctr.
Contract Management GSA/FSS EnerSys
Convergys Erickson Air Crane
Cooper Nuclear Station European Centre for TQM
Cooper Standard Automotive Evans Capacitor Company
Corpus Christi Army Depot Evans Consoles Corporation
Covansys Eveready Battery Co.
Credit Suisse Exeltech
Credit Suisse Americas Exsilon Data & Statistical Solutions

60 I NOVEMBER 2007 I www.asq.org

ASQ Sustaining and Organizational Members
ExxonMobil Business Support Center
Argentina SRL
E-Z-EM Inc.
FAA DOT
FAA Logistics Center
FEMA-Texas National Processing
Service Center
FHWA Corporate Management
FLIR Systems Inc.
FMF Cape Scott (HMC) Dockyard
FT Interactive Data
FUNDECE
Fansteel Wellman Dynamics
Federal Bureau of Investigation
Femme Comp Inc. (FCI)
Fermi National Accelerator
Laboratory
Fidelity Investments
Fite Fire & Safety
Fleet Readiness Center-Southeast
Flexfab Division of FHI
Florida Department of Health
Fluor Corporation
Ford Motor Company
Fort Hays State University
Freedman Seating Company
Freightliner Custom Chassis Co.
Fresenius Medical Care
Fundacion Navarra Para La Calidad
Fundacion Universidad de las
Americas Puebla
Furukawa Mexico S.A. de C.V.
GA Services Private Limited
GE Healthcare
GECOM Corporation
GTECH Corporation
GenCorp Aerojet
General Chem.
General Dynamics
General Dynamics C4 Systems
General Dynamics Ordnance and
Tactical Systems
General Electric Healthcare
General Systems Company
Gennum Corporation
Genworth Financial
Genzyme
Gerber Products Co.
Goodrich Corp-AIP-Propulsion
Systems
Goodrich Landing Gear
Goodwill Industries of Southeastern
WI Inc.
Gopher Resource Corporation
Greene Tweed & Co.
Guidon Performance Solutions LLC
Gulfstream
HDR Architecture, Inc.
HNC for EOQ
HSN
Hach Company
Hamilton Sundstrand de Puerto Rico
Hammond Company
Hamriyah Free Zone
Hansen Medical
Hardigg Industries, Inc.
Harland
Harrington Group, Inc.,The
Harvard Custom Manufacturing
Health Quality Partners
Heico Corporation
Hendrickson International
Hertzler Systems, Inc.
Hewitt Mobility Services
Hill Phoenix
Hindustan Aeronautics Limited
Hitachi Computer Products (America)
Honeywell
Honeywell Inc. CAS
Hospira
Hospira, Inc.
Hotels & Resorts of Halekulani
Huitt-Zollars, Inc.
Humana, Inc.
Humphrey Products
Husky Injection Molding Systems Ltd.
Hutchinson Technology
Hyundai Engineer/Construction
IMSM Inc.
ISIK Universitesi
IT Worx
IdaTech
Illinois Central College
Infonet Services Corp.
InfoSENTRY Services, Inc.
Institute of Technology Sligo
Integrated Project Management
Co.,Inc.
Integration Technologies Group, Inc.
Integrys Energy Group
Intelemedia Communication Inc.
Intellisys Technology LLC
Interactive Data (Europe)
International Immunology Corp.
Interplex Engineered Products Inc.
Intimate Fashions India Private Ltd.
JDS Uniphase Corp.
JHM Research and Development, Inc.
J.L. Herren and Associates P.C.
JTI Systems, Inc.
Jackson State Community College
Jacobs Technology
JayCat Inc. dba Carlson Products
The Jay Group
Jeppesen
Johnson Electric North America
Jones Packaging Inc.
KGS Electronics
KSM Electronics, Inc.
KalDer Mine Safety Appliances Co.
Kamehameha Schools Minitab Inc.
Kellogg Canada Inc. London Plant Minntech Corporation
Kimball Electronics Group Mirus Consulting Group Corp.
Kohler Company Misr Compressors Manufacturing Co.
Korea Hydro & Nuclear Power Co. Missouri Enterprise
Korean Air Mittal Steel Indiana Harbour
Korean Foundation for Quality ModusLink
Korean Standards Association Moore Norman Technology Center
Morgan AM&T SM Site
KraftMaid Cabinetry
Mt. Lebanon School District
Krenz & Company, Inc.
Mutual of Omaha Insurance Co.
Kuwait Airways
NASA Shared Services Center
L-3 Communications MAS (Canada)
Inc. NB Power Nuclear
LAM Research Corporation NCCI Holdings, Inc.
LMI NSF International
LMSSC Astronautics Operations Nalco Co.
Laboratorios PISA S.A. de C.V. Naperville Park District
Landoll Corporation National Center for Biomedical
Research and Training
Learjet Inc.
National Geospatial Intelligence
Lee Hecht Harrison
Agency
Lemcon Networks Ltd.
National Graduate School
Letterkenny Army Depot
National Institute for Occupational
Lifestar
Safety & Health
Liphatech, Inc.
National Institute of Standards &
Lloyd's Register Quality Assurance, Technology
Inc.
National Productivity Corp.
Logistics Company, Inc.
National Quality Review
L'Oreal USA
National Seafood Inspection Lab
Lozier Corporation
National Security Technologies
MASHAREA Project Management
National Semiconductor
MEDRAD, Inc.
Naval Air Depot North Island
MITRE Corp.
Naval District Washington
MTC Technologies, Inc.
Naval Facilities Engineering
MVA Scientific Consultants Command
Mack Truck Naval Surface Warfare Center
Malaysia Airlines Naval Under Sea Warfare Center
Manpower Nebraska Service Center
Market Probe, Inc. Neptune Technology Group Inc.
Martinez Magallenes Consultores, New Mexico Dept. of Transporation
S.C. Ngee Ann Polytechnic Library
Martinrea Nike, Inc.
Masonite Nisshinbo Automotive Corporation
Materus Nobel Biocare
Matsushita Electronics Nokia Investment Co., Ltd.
Mayo Clinic Nokia Siemens Networks
McAlester Army Ammunition Plant Nordam Group Inc.
Measurement Canada Norfolk Naval Shipyard
MedCentral Health System Norlen, Inc.
Med Exec International Northridge Hospital Medical Center
MedImmune Vaccines Inc. Northrop Grumman Space Tech
Medtronic Diabetes Novartis Vaccines and Diagnostics
Medtronic Inc. Novaxa Consulting
Mercy Memorial Hospital Novo Nordisk Pharmaceutical
Metagenics Industry Inc.
Metaldyne OAI Electronics
Mettler Toledo ODL, Inc.
Midway USA OFS
Milliken & Co. OMNEX
QUALITY PROGRESS I NOVEMBER 2007 I 61
ASQ Sustaining and Organizational Members
Office of the Comptroller (Puerto
Rico)
Office of the Comptroller of the
Currency (USA)
Oracle Corporation
Orchid Cellmark
Orion Development Group
Orthodyne Electronics
Owen's Fasteners Incorporated
PACCAR Inc.
Pacific Gas & Electric Company
Pacific Southwest Container
Packages Limited
Pall Corporation
Palmetto GBA
Panduit Corp.
Parker Hannifin Corp.
Paychex
Pearson Educational Measurement
Pella Corporation
Pentron Clinical Technologies LLC
Perfecseal
Petrobras America Inc.
Petroleum Helicopters
Petropars Ltd.
Pfizer, Inc.
Pfizer-Groton
PharmEng Technology Inc.
Pharma Tech Industries
Physicians' Clinic of Iowa P.C.
Pilot Chemical Company
Placon
Plastic Art Products
Pontificia Univ. Catolica Peru
PredictionProbe Inc.
Premier Bankcard
Prince William County Public Schools
Procter & Gamble Company
Product Action International
Productivity Quality Systems
Purdue University TAP
QMI
Qatargas Operating Company Ltd.
Quality Bolt & Screw Company
Qualiware Inc.
RAE Ingenieros SA
RDECOM-Rock Island Arsenal
RIT/CQAS
Racine Unified School District
Ramallo Bros. Printing, Inc.
Rand E. Winters Group, Inc.
Rauland-Borg Corp.
Raytheon
ReedHycalog LP
Regeneration Technologies, Inc.
Regis University
Reliance Industries Limited
Republic Polytechnic
62 I NOVEMBER 2007 I www.asq.org
Rescar Companies
Retractable Technologies, Inc.
Rhodes State College
Richland College
Rochling Automotive Duncan, LLP
Rockford Health System
Rockwell Automation
Rohmann Services
Ross Memorial Hospital
Rutland Mental Health Services, Inc.
SAI Global
SAIC
SAIC-Frederick
SAS Institute, Inc.
SC Dept. of Health & Envir. Control
SC Johnson Europlant B.V.
SED Systems
SGS
Saab Barracuda LLC
Saint-Gobain Vetrotex America, Inc.
Sanofi Pasteur Limited
SaskWater
Sauder Woodworking
Saudi Cable Co.
Saudi Electricity Company
Schaller Anderson of Tennessee LLC
Schauer Independent Insurance Corp.
Schering-Plough
Schering-Plough Consumer
Healthcare Inc.
Schering-Plough Products LLC
Schering-Plough Research Institute
Schleifring Medical Systems
School District of Lee County, The
Sedgwick Claims Management
Services Inc.
Sentara Virginia Beach General
Hospital
Serigraph Inc.
Shorewood Packaging
Sid Richardson Carbon Co.
Siemens Business Services, Inc.
Siemens Medical Solutions USA Inc.
Silvex, Inc.
Singapore Quality Institute
Sloan Valve Co.
SoBran, Inc.
Social Security Administration
Sorenson BioScience
South Texas Veterans Health Care
System
Southern California Edison
Southern Management Corp.
Space & Naval Warfare Systems
Center
Span International
Span Packaging Services LLC
Spectra-Physics
Spellman High Voltage
Sprint
Standards Council of Canada
Stat-A-Matrix
Stat-Ease Inc.
Sterlite Optical Technologies, Ltd.
St. Jude Medical Puerto Rico
Strategic Solutions, Inc.
Stryker Instruments
Sullair Corporation
Superior Air Parts, Inc.
Superior Die Set Corporation
T & S Brass and Bronze
TALX Corporation
TATA Consultancy Services
TBS Shipping Services Inc.
TEQ GmbH
TIC Gums
TQM Consulting Group Inc.
(TQMCG)
TQM Network
TSTC Harlingen
TWSCO
Talley Defense Systems
Tata Consultancy Services Ltd.
Tata Motors
Technicolor Mexicana S. de R.L. de
C.V.
Tektronix Inc.
Telmar Network Technology, Inc.
Tenneco
Teresian House Nursing Home
Texas Service Center
Thai German Specialty Glass Co.,
Ltd.
Thayer Medical
ThyssenKrupp Waupaca, Inc.
Timber Creek Consulting Group
Timken Company, The
Tobyhanna Army Depot
Toronto Public Health
Traex
TrailBlazer Health Enterprises
Transcontinental Direct
Transport Canada
Trinidad & Tobago Bureau of
Standards
TriWest Healthcare Alliance
Tube Supply, Inc.
Tyco Fire and Building Products
UAB Center for Biophysical Sciences
and Engineering
UCSF
UL-CCIC Company Ltd.
URS
US Army TACOM ARDEC
US Department of Energy
US Mint
US Naval Ship Repair Facility
Yokosuka Japan
US Office of Personnel Management
USAF Air Combat Command
USDA APHIS PPQ CPHST
USDA GIPSA CP
USE/BTCA General Universitaria
USIMINAS
Ulticom, Inc.
Union Pacific Railroad
Unisia Steering Systems Inc.
Unisia of Georgia Corp.
United Grinding Technologies, Inc.
United Space Alliance
United States Enrichment Corp.
United States Marine Corps
Universidad de Guanajuato
University of Alabama
University of Central Missouri
University of Central Oklahoma
University of Cincinnati
University of Northern Colorado
University of Texas MD Anderson
Cancer Center
University of Wisconsin-Stout
VBCPS Organizational Development
VIPS
VIP Tooling Inc.
Vasogen Inc.
Ventana Medical Systems
Veridian Homes
Verify, Inc.
Vertex Pharmaceuticals Incorporated
Vertis, Inc.
Viracon
Volvo Truck North America
Vought Aircraft Industries, Inc.
WR Grace
W. W. Grainger, Inc.
Wackenhut Services, Inc.
Wallac Oy
Wal-Mart Stores, Inc.
Washington Dental Service
Washington Mutual
Water Corporation
Watlow Winona
Waukesha Memorial Hospital
WePackItAll
Wilbur Curtis Co., Inc.
Wm. Wrigley Jr. Company
World Class Manufacturing Group
Inc.
World Wide Technology
Xandex Inc.
XICOM Technology
Ygomi, LLC
Yoder Die Casting Corp.
Yuma Regional Medical Center
Yusa Corporation
Zippo Manufacturing Co.
 SUSTAINING MEMBERSHIP APPLICATION OFFICE USE ONLY
MBHEG28
PRIORITY CODE ______________________
All employees at a single site of a Sustaining member organization are entitled to Sustaining membership
Order Number ________________________
benefits. If your organization has more than one site, each site must become a Sustaining member to
share Sustaining membership benefits with its employees. Identify one primary contact who will receive Member Number ______________________
all ASQ related information, and should disseminate this information throughout your organization.

PRIMARY CONTACT INFORMATION

K Mr. K Ms. K Mrs. K Dr. K Male K Female

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 QP
REVIEWS
The Quality Rubric
Steve Benjamin, ASQ Quality Press, 2007,
112 pp., $28.35 member, $47.25 list (book).
The Quality Rubric: A Systematic
Approach for Implementing Quality
Principles and Tools in Classrooms
and Schools is a useful reference tool
for decision makers with knowledge
of quality tools, procedures and
vocabulary to use as a rubrics guide
to teaching-learning programs.
Intended for K-12 educators deliver-
ing teaching-learning support, this
book starts with a two-page definition
section followed by an introduction to
the quality rubric.
For readers new to tools, systems
and the language of quality, Benja-
min’s book might be a challenge, but it
will definitely be an effective learning
tool. This book is a reference to deliv-
ering quality-as-process and quality-
as-result in classrooms and schools.
The book is organized into three
parts: introduction to the quality
rubric, the quality rubric in the class-
room and the quality rubric in a
school. Continuous improvement,
data driven decision making, systems
thinking, teamwork, and focus on
stakeholders and reporting of results
are topics highlighted in this book.
With a plan-do-check-act philosophy
at the core of the rubric, this book is a
tool for delivering results.
The use of graphics and figures,
lists and examples from actual
schools and classrooms make this
book a useful tool. The book is effec-
tive as a reference to a team working
to extend quality in classrooms. It is
also useful to students being intro-
duced to the quality rubric.
Jerry Brong
Ellensburg, WA
Lean Sigma: A
Practitioner’s Guide
Ian D. Wedgwood, Prentice Hall, 2007, 744
pp., $59.99 (book).
The purpose of Lean Sigma: A
Practitioner’s Guide is to provide
those using the Six Sigma method
with best practices and tool roadmaps
for completing a broad range of pro-
jects. The book is divided into three
major sections: Section one provides
64 I NOVEMBER 2007 I www.asq.org
solution roadmaps to 25 different
types of problems, section two covers
the topic of project identification, and
section three covers the explanation
and application of 55 different lean
and Six Sigma tools.
The main strength of the book lies
in the project and tool roadmaps.
They cover the common problems
Black Belts encounter. In addition,
each roadmap takes you step by step
through problem solving within the
scope of the define, measure, ana-
lyze, improve and control process.
The roadmaps allow a Black Belt to
see how the lean tools logically con-
nect with one another to solve a par-
ticular problem and why a specific
tool might be used at a specific stage.
This book is detailed enough to
enable a Black Belt who is unfamiliar
with a tool to use it in a project and
then interpret the results of using it.
If there is one weakness in the
book, it is the chapter on project dis-
covery. It was quite thin compared to
other chapters and more information
could have been provided on that
topic.
Overall, this is a book that will be
very useful for everyone from novice
Black Belts to those who are more
experienced. Master Black Belts and
champions can also use this book to
make sure Black Belts have addressed
all the steps necessary to complete a
project. Six Sigma practitioners will
find this book a welcome and fre-
quently used addition to their
libraries.
Brian Cocolicchio
Quest Diagnostics
Teterboro, NJ
Collaborative Process
Improvement
Celeste LaBrunda Yeakley and Jeffrey D.
Fiebrich, Wiley-Interscience, 2007, 178 pp.,
$59.95 (book).
Collaborative Process Improvement:
With Examples From the Software
World is a detailed and prescriptive
roadmap to the standardization of
process improvement.
Although the subtitle refers to the
software world and the focus is on
quality, the recommendations are
applicable to any process chosen for
implementation or improvement. All
that is required is some adaptation.
Yeakley and Fiebrich have efficient-
ly and effectively summarized their
experiences with improvement and
have tried to provide a single-source
training tool. They have succeeded in
doing so and have gone further by
identifying benefits, breakthroughs,
time and cost savings, collaborative
or global impact and results. Also
included are aids and exercises for
both the novice and experienced
enhancement campaigner.
Although nothing should ever be
guaranteed, this process outlines all
the steps needed for success if pre-
sented in a manner suitable to the
company culture. Diligently following
this plan will result in efforts that will
bear scrutiny by the harshest critics in
the unlikely event that improvement
aims are not fully realized.
Within each chapter there are sum-
maries, checklists, guidelines, consid-
erations and decision stimulators to
help with the implementation and fur-
therance of the improvement process.
Also included are an index, dictionary
and bibliography for further study.
Anyone assigned as an improvement
leader will benefit from reading this
book and using the provided tools.
If the book lacks anything, it is a
sufficient number and breadth of
examples. Those that are provided
have been generalized and shortened.
Details on the exact occurrences
would provide better understanding
for individuals without much experi-
ence in leading change efforts. Still, I
think this book is worth having on the
bookshelf. It provides excellent guid-
ance for any improvement champion
or implementation endeavor.
Marc A. Feldman
Solvay Chemicals
Houston
Six Sigma: Advanced
Tools for Black Belts and
Master Black Belts
Loon Ching Tang, Thong Ngee Goh, Hong
See Yam and Timothy Yoap, Wiley, 2006,
426 pp., $130 (book).
Six Sigma: Advanced Tools for Black
Belts and Master Black Belts is an inte-
grated collection of 25 chapters, bro-
ken into five parts, relating to the
define, measure, analyze, improve and
control process. The most important
feature of the book is that it is not a
how-to book. Topics are presented in a
readable style, and the chapters are
comprehensive, including an introduc-
tion followed by examples and refer-
ences. Sample topics include: a
strategic assessment of Six Sigma,
mind maps, reality trees and fishbone
diagrams.
The topics vary in their conceptual
and mathematical content. To fully
benefit from the book, the reader
must be capable of following articles
published in the Journal of Quality
Technology, Quality Technology and
Quantitative Management or Quality
and Reliability Engineering Inter-
national. Master Black Belts and most
Black Belts at that level will find the
book a good reference for addressing
nonstandard problems and introduc-
ing new ideas into their practices.
The authors have been involved in
many Six Sigma programs in the
Asia-Pacific and have provided signif-
icant added value to the companies
they worked for. The knowledge and
experience included in this book will
be useful to individuals involved in
such programs.
Ron Kenett
KPA
Raanana, Israel
and general well being of the patient. R E C E N T R E L E A S E S
This results in an emphasis on reim-
bursable procedures while neglecting
other more important prevention pro- The Team Building Toolkit:
cedures that offer little monetary Tips and Tactics for Effective
incentives.
The second part of the book pro- Workplace Teams, second edition,
vides an introduction to Six Sigma Deborah Mackin, Amacom, 2007, 223
and its applications in healthcare
pp., $17.95 (book).
industries. Six Sigma case studies
from selected healthcare organiza-
tions are featured. The last part of the
book offers implementation strategies Introduction to Distribution
for treating Six Sigma as a cultural Logistics, Paolo Brandimarte and
change.
Giulio Zotteri, Wiley-Interscience, 2007,
I strongly recommend this book to
healthcare professionals learning 587 pp., $99.95 (book).
how Six Sigma can help them oper-
ate more effective healthcare organi-
zations. Business Process Improvement
Shin Ta Liu Toolbox, second edition, Bjørn
Lynx Systems Andersen, ASQ Quality Press, 2007,
San Diego
312 pp., $37.80 member, $63 list (book).
ADVERTISERS INDEX
ADVERTISER PAGE PHONE WEB
AssurX, Inc. 5 408-778-1376 www.assurx.com

Baldrige National Quality 9 301-975-3199 www.quality.nist.gov

Program NIST
Improving Healthcare
EtQ, Inc. 1 516-293-0949 www.etq.com
Quality
Brett E. Trusko, Carolyn Pexton, H. James Manufacturing, ASQ 73 414-272-8575 www.asq.org
Harrington and Praveen Gupta, FT Press,
2007, 650 pp., $59.99 (book). Membership, ASQ 49, 50, 60-63 414-272-8575 www.asq.org

Improving Healthcare Quality and PQ Systems, Inc. 36 800-777-3020 www.pqsystems.com

Cost with Six Sigma provides a com-
pelling case for why improvement in Qualitech, Inc. IFC 248-344-9590 www.iq-fmea.com
quality and cost in healthcare fields is
needed. It further highlights Six Sigma Quality Council of Indiana 16, 17 812-533-4215 www.qualitycouncil.com
success stories, which are already
being adopted in manufacturing and SAI Global 42 800-374-3818 www.xlp.com
business fields, as the methods need-
ed to achieve this improvement. Six Sigma Institute 24 480-515-0890 www.sixsigmamindpro.com
The first three chapters present the
reasons cost cutting and quality Statistical Process Controls 2 865-584-5005 www.spcpress.com
improvement are important. The
healthcare field is unique in terms of Statit Software 48 541-738-2222 www.statit.com
its cost structure and end products
because the current reimbursement StatPoint, LLC 7 540-364-0420 www.statpoint.com
system in healthcare actually encour-
ages inefficient practices. The govern- StatSoft, Inc. 74 918-749-1119 www.statsoft.com
ment pays for curing a defined
sickness but not for the prevention Upper Iowa University 31 515-369-7777 www.uiu.edu

QUALITY PROGRESS I NOVEMBER 2007 I 65

 QP
CALENDAR
To receive information or to register for ASQ
Education Courses and Conferences, contact
Learning Offerings, ASQ, 600 N. Plankinton
Ave., Milwaukee, WI 53203, call 800-248-1946
or 414-272-8575, fax 414-272-1734 or visit
www.asq.org.
D E C E M B E R
3-4 Supply Chain Operations Reference
Training. Miami. Call the Supply-Chain
Council at 202-962-0440 or visit www.supply-
chain.org.
3-5 How to Align People and Processes
for Results. Los Angeles. Call 800-466-9953
or e-mail jan@bizmanualz.com.
4-6 Experiment Design Made Easy.
Minneapolis. Call Stat-Ease at 612-378-9449
or visit www.statease.com/training.html.
5-7 Introduction to MINITAB and Basic
Data Analysis. San Francisco. Call Kevin
Potcner at 800-930-8528 or visit www.
exsilondata.com.
6-7 Demonstrating Reliability With
Accelerated Testing. Denver. Call Hobbs
Engineering at 303-465-5988 or visit www.
hobbsengr.com.
6-7 Problem Reporting, Root Cause
Analysis and Corrective Action. Dallas. Call
Ben Marguglio at 845-265-0123 or visit
www.hightechnologyseminars.com.
7 ASQ Conference. 63rd Annual Deming
Conference on Applied Statistics. Atlantic
City, NJ.
9-12 19th Annual National Forum on
Quality Improvement in Healthcare.
Orlando, FL. Call the Institute for Healthcare
Improvement at 617-301-4800 or visit
www.ihi.org.
66 I NOVEMBER 2007 I www.asq.org
10-14 Strategic Marketing Management.
University of Chicago Graduate School of
Business. Call Amanda Felt at 312-464-8732 or
visit www.chicagoexec.net.
J A N U A R Y
14-15 International Conference on
Design of Industrial Experience. Antwerp,
Belgium. Visit www.ua.ac.be/doe or e-mail
doe@ua.ac.be.
17-18 Improving Quality, Product
Safety and Preventing Product Liability
Lawsuits. Los Angeles. E-mail Randy
Goodden at rgoodden@go.com.
21-22 ASQ Education Course. Lean
Enterprise. Toronto.
F E B R U A R Y
4-5 ASQ Education Course. Systematic
Problem Solving for Sustained Improvements
with Quality Tools. Calgary, Alberta.
4-7 ASQ Education Course. Guide to
Process Improvement and Change.
Halifax, Nova Scotia.
4-8 ASQ Education Course. Introduction
to Quality Engineering. Toronto.
5-8 The Road to Sustainability:
Implementing Green and Seeing Gold.
Houston. Call APQC at 800-776-6976 or visit
www.apqc.org.
11-12 ASQ Conference. Six Sigma
Conference: Sustainable Growth Through
Lean Six Sigma. Phoenix.
11-12 ASQ Education Course.
Systematic Problem Solving for
Sustained Improvements with Quality
Tools. Toronto.
13-14 ASQ Education Course.
Excellence in 8 Dimensions. Phoenix.
13-14 ASQ Education Course. Lean
Enterprise. Phoenix.
13-14 ASQ Education Course. Lean for
Service. Phoenix.
13-14 ASQ Education Course. Managing
and Leading in a Six Sigma World. Phoenix.
13-14 ASQ Education Course. Quality
Cost Principles. Phoenix.
17-23 Engineers Week. Alexandria, VA.
Call 703-684-2852 or visit www.eweek.org.
18-19 ASQ Education Course. Blended
ISO 9001:2000 Lead Auditor Training.
Las Vegas.
18-19 ASQ Education Course. Lean Six
Sigma for Healthcare Executives. Las Vegas.
18-19 ASQ Education Course. Using
Control Charts to Interpret Healthcare
Data. Las Vegas.
18-22 ASQ Education Course. Black
Belt/Quality Engineering Statistics.
Las Vegas.
28-29 Crafting Your Systems Portfolio
Workshop. Lisle, IL. Visit Academic Quality
Improvement Program at www.aqip.org.
Have an event you’d like
included in “QP Calendar”?
Submit information at least
three months in advance to
vfunk@asq.org. Non-ASQ
organizations may list one
event per issue.
 For information on placing an ad,

Professional Services contact Ramona Garcia at 800-248-1946,

or 414-272-8575, or e-mail rgarcia@asq.org

What does earning a degree mean to you?

Career advancement? Greater opportunities? Personal development?
With distance learning, all these things are within your reach.
California National University for Advanced Studies (CNU) is an accredited distance-learning university designed for technical and business
professionals. The CNU College of Quality and Engineering Management includes a Bachelor of Quality Assurance Science and a Master of
Engineering Management. Combining distance learning with one-on-one instruction, CNU degree programs provide maximum flexibility for maximum
growth. The Bachelor of Quality Assurance Science prepares the individual to be able to manage, plan, procure, design, and maintain an effective
Quality Assurance Program within a company. The Master of Engineering Management provides the individual with the breadth of knowledge required
for succesful project management, and with the ability to integrate knowledge from diverse disciplines.
CNU also offers seven other degree programs and courses by extension for those who prefer to begin their continued education gradually.

Let CNU help you take it to the next level.

Contact one of our admissions representatives at 800-782-2422 or e-mail cnuadms@mail.cnuas.edu.

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Email sales@qualitytng.com for brochure

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To purchase visit: www.amazon.com
Call: 847-884-1900 (or) 800-680-0700
Visit us at: www.qtcom.com
McRINK FAR EAST SERVICES
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Ph. 610-409-0168 Fax 610-409-0167
Entwining ISO, Lean, & 6σ
• Advanced Internal Auditor Training
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Downsizing inhouse Q.A.? Michael J. Micklewright, CSSBB, CQMgr, CQA, CQE
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QUALITY PROGRESS I NOVEMBER 2007 I 67

 For information on placing an ad,

Professional Services contact Ramona Garcia at 800-248-1946,

or 414-272-8575, or e-mail rgarcia@asq.org

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68 I NOVEMBER 2007 I www.asq.org

 For information on placing an ad,

Professional Services contact Ramona Garcia at 800-248-1946,

or 414-272-8575, or e-mail rgarcia@asq.org

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TM

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ACCREDITED HUMIDITY CALIBRATION

I S O / I E C 17025
NIST TRACEABLE STANDARDS
Relative Humidity.................. 0.5% to 99%
Dew / Frost Point.............. -90 °C to 70 °C
Volume Ratio, V (PPM)........ 0.1 to 250,000

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QUALITY PROGRESS I NOVEMBER 2007 I 69

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QUALITY PROGRESS I NOVEMBER 2007 I 71

BACK TO
BASICS
Zero Defect Sampling
O
ne perk of being a quality pro-
fessional is running across a sta-
tistical rule of thumb that has
application to the quality sciences.
One such gem is the rule of threes—a
paper and pencil technique that pro-
vides a simple way to add up risk
around defect-free claims.
The rule of threes is the upper
bound of a 95% statistical confidence
interval for how poor quality can be
consistent with finding zero defects in
a random sample. The formula for the
upper bound of the interval is
p = 3/ n
in which a random sample of size n is
used to determine the upper limit risk,
or p. The lower bound of the confi-
dence interval will always be zero. In
other words, the 95% confidence inter-
val would be written as 0, 3/n. What
the confidence interval generalizes is a
range of values likely to contain the
true defect rate given zero observed
defects in a random sample of size n.
The 95% simply refers to a 0.95 prob-
ability that the confidence interval con-
structed from the initial sample
captures the true defect rate. The value
Rule of 3s
For the mathematically curious,
the rule of threes can be derived
from the binomial model. Briefly
sketched, if given a sequence of n
independent trials—with a pass
or fail outcome on each trial—the
test statistic for the defect propor-
tion, p, will follow a binomial dis-
tribution with parameters n and
p. The probability of seeing zero
failures in n trials is computed
with the binomial distribution as
(1–p)n. Setting (1–p)n = 0.05 (the
5% risk level), and using natural
logarithms to solve the equation,
we have n ln(1–p) –3. For small p,
ln(1–p) – p so – np = –3 or p = 3/n.
The rule of threes works best for
sample sizes of 20 or more. A
similar derivation can be obtained
with the Poisson model. —T.G.
72 I NOVEMBER 2007 I www.asq.org
by Tony Gojanovic
of the confidence interval in quality
applications is to temper overly opti-
mistic expectations associated with
finding zero defects in a sample with a
statement of potential defect values. In
Using the rule of
threes for evaluating
defect-free claims
the instance of actually having the
worst case risk, it can be shown that the
95% implies the probability of finding
one or more defects in the sample.
The formula is only valid for ran-
domly selected samples, or if the
defects are randomly distributed
through the population under investi-
gation. The following examples show
the wide applicability of this formu-
la—each case assumes inspection
error is negligible, which might not
always be the case.
Table 1 lists some other approxima-
tions for different confidence intervals
that are useful.
Problem: What is the risk statement
for 100 randomly selected electronic
components from an assembly line
that are tested for a specific defect if
zero defects are observed?
Solution: Using n = 100 and the rule
of threes, there is an upper level risk of
3/100, or 0.03, with 95% confidence.
Given the risk level selected, the actual
failure level could be between 0% and
3%, and still be consistent with zero
observed defects in a sample of 100. If
the lot actually contains the worst case
rate of 3% defects, the likelihood of
finding one or more defects in the sam-
ple is 95%.
Problem: A beer bottle manufactur-
er informs the quality manager of a
large brewery that the bottling
process is generating a certain type of
defect, and he thinks the defect pro-
portion might be 1 in 5,000 bottles
(0.02%) or higher. You have a large
amount of suspect pallets on hold,
and you need to find out if the hold
has defective bottles in it. What sam-
ple size do you need to ensure that
you will find one or more defects with
95% confidence?
Solution: Working backward using
the rule of threes, the following facts
TABLE 1
Approximations for Different
Confidence Intervals
Upper bound or
Confidence Level
worst case risk
86.5% 2/n
95% 3/n
98.2% 4/n
99.3% 5/n
are known: p = 0.0002 (the same as
0.02%) and n is not yet known. The
rule is p = 3/n, which implies n = 3/
p. Solving for n, there is n = 3/p =
3/(0.0002) = 15,000 bottles.
At least 15,000 bottles would need
to be randomly inspected to have 95%
confidence of capturing one or more
defective bottles.
There are other situations in which
the question might address a defect
level consistent with one defect found,
and rules can also be derived for those
situations. But more commonly encoun-
tered in practice, and often more criti-
cal, is the situation when zero defects
are found in a sample and the free
claim is to be evaluated in terms of
defining the potential risk.
BIBLIOGRAPHY
Hanley, James A. and Abby Lippman-
Hand, “If Nothing Goes Wrong, Is
Everything All Right?” The Journal of the
American Medical Assn., April 1983, Vol.
249, No. 13, pp. 1,743-1,745.
Jovanovic, B.D. and P.S. Levy, “A Look at
the Rule of Three,” The American
Statistician, May 1997, Vol. 51, No. 2, pp.
137-139.
Louis, Thomas A., “Confidence Intervals
for a Binomial Parameter After
Observing No Successes,” The American
Statistician, August 1981, Vol. 35, No. 3,
p. 154.
Van Belle, Gerald, Statistical Rules of
Thumb, John Wiley & Sons, New York,
2002.
TONY GOJANOVIC is
a statistician at Coors
Brewing Co., Golden, CO.
He earned his master’s
degree in mathematics and
statistics from the University
of Colorado in Denver. He
is a member of ASQ.
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