Advancing Performance Excellence

www.asq.org OCTOBER 2007

What’s in Your
Grocery Bag?
How ISO 22000 and HACCP
Ensure Safe Food p. 21

PLUS:
Medical Device
DMAIC Case Study p. 28
Lean in the Office p. 54
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Contents OCTOBER 2007 I VOLUME 40 NUMBER 10

F E AT U R E S
FOOD SAFETY

21 A Recipe for Safe Food: ISO 22000 and HACCP

Recent high profile food recalls highlight how these essential quality
ingredients can make a food safety management system effective.
JOHN G. SURAK, principal, Surak and Associates, Clemson, SC

SIX SIGMA

28 Achieve Compliance Through CI

A medical device company incorporated Six Sigma’s DMAIC process
as part of its continuous improvement efforts to meet FDA regulations.
ALAN F. CHOW, instructor Mitchell College of Business, University of South Alabama, Mobile

RONALD BOWMAN, director of quality and regulatory affairs, Optical Integrity Inc.,
Panama City, FL

LEONARD C. WITTENBERG, program leadership office Six Sigma lead, Raytheon, Dallas

SARBANES-OXLEY ACT

34 ASQ Team Says QMS and EMS

Standards Support SOX
ASQ experts offered advice to the federal government on ways
to infuse quality into SOX management and compliance processes.
SANDFORD LIEBESMAN, consultant, Morristown, NJ

CASE STUDY

40 Agency Files Away Inefficiency,

Saves Taxpayers a Bundle
C H E C K O U T Quality tools helped a Florida social services agency revamp its
The ASQ website! document storage system and save millions of dollars.
VISIT

www.asq.org SUSAN E. DANIELS, editor at large

• Web Watch. QUALITY FUNCTION DEPLOYMENT

• Author guidelines.
• Searchable database of ASQ
abstracts.
• Index of back issues.
For ASQ members only:
• Salary surveys from 1995 to 2006.
• Complete feature articles since 1995.
• QP Discussion Board.
45 DFX and DFSS: How QFD Integrates Them
A QFD system offers manufacturers a way to combine these two
powerful design methods and build better quality products.
JUI-CHIN JIANG, associate professor, department of industrial engineering, Chung Yuan
Christian University (CYCU), Taiwan
MING-LI SHIU, recent doctoral graduate, department of industrial engineering, CYCU
MAO-HSIUNG TU, president, D&N Business Consulting Co., Hsin-Chu City, Taiwan
D E PA R T M E N T S QualityProgress
6 Up Front TABLE OF CONTACTS
Inspections aren’t the answer.
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UPFRONT
QualityProgress
Inspections Aren’t the Answer
Publisher
n this month’s cover, we ask, “What’s in your grocery bag?” In light WILLIAM A. TONY

O of recent events, we could have just as easily asked, “What’s in your

pet’s food dish?” Or in your kids’ toy boxes, for that matter?
Editor
SEICHE SANDERS

Associate Editor
The recent flurry of recalls—on everything from toothpaste to Barbie MARK EDMUND
accessories—has been a black eye for some of the world’s largest producers Assistant Editor
of consumer products. These widespread events—and the resulting media BRETT KRZYKOWSKI

attention—underscore the need for quality and improvement in the food Manuscript Coordinator
VALERIE FUNK
supply chain and beyond. It will take significant
Editor at Large
progress in this arena before we see the desired re- SUSAN E. DANIELS
sults. Until then, the already record number of Contributing Editor
recalls will continue to escalate. NICOLE ADRIAN

At press time, several large companies with palpa- Copy Editors

SUSAN GRONEMUS
ble clout—think Disney and Wal-Mart—responded KELLY SULLIVAN
to toy quality issues by announcing aggressive plans
Art Director
to inspect or institute third-party inspections of the MARY UTTECH
toys they sell. Certainly, this is not the best solution to Graphic Designer
the problems, but given the significant costs involved, producers will likely SANDY WYSS
Production
be spurred to action when they are held acccountable for that expense.
CATHY SCHNACKENBERG
Quality Progress continues to cover the stories behind the recalls in the
Advertising Production
Quality News Today online daily news postings (available at www.asq.org) BARBARA MITROVIC
and within the pages of this magazine. This month, we highlight food Digital Production Specialists
ERIC BERNA, LAURA FRANCESCHI
safety in John Surak’s article, “A Recipe for Safe Food: ISO 22000 and
HACCP” (p. 21). The article explains how these two approaches work
Account Executives
together to create an effective food safety management system, and how ANGELA M. MITCHELL
their proper implementation can contribute to quality throughout the MITCHELL PEZANOSKI

entire supply chain. Classified/Recruitment Advertising

RAMONA GARCIA
Stepping up inspections won’t address the real cause of today’s recalls.
This point is neatly recapped in the June 2007 Quarterly Quality Report, Marketing Administrator
MATT MEINHOLZ
“Food Safety—A Quality Management Systems Approach,” released by
Editorial and Advertising Offices
ASQ (www.asq.org/quality-report/reports/index.html). 414-272-8575 fax 414-272-1734
“The problem is, the science of quality has told us that more inspection
ASQ ADMINISTRATION
is not going to inspect the defect out of the product,” said Steve Wilson, Executive Director
PAUL E. BORAWSKI
chief quality officer for the U.S. Commerce Department’s Seafood
Managing Directors
Inspection Program and an ASQ board member. “Asking, ‘Do we need
CHRISTOPHER D. BAUMAN
more inspectors?’ is a loaded question, because usually you do need more BRIAN J. LEHOUILLIER
MICHELLE MASON
inspectors—but only because of the way the current system is designed.”
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
does not necessarily constitute endorsement of that particular
Seiche Sanders product or service by ASQ.

Editor

6 I OCTOBER 2007 I www.asq.org

 QP
MAILBAG
Six Sigma, Innovation
Can and Do Co-exist
A very important question was
raised in the “Up Front” col-
umn (August, p. 6)—one that is mis-
understood by many people who
overzealously adopt a single improve-
ment process, tool or other technique.
The editor asked, “Can Six Sigma and
innovation work within the same four
walls?” I believe the answer is
unequivocally, “Yes.”
This discussion, which is far from
new, always reminds me of a pam-
phlet that was written by former ASQ
President Dana Cound in 1986 for
National Quality Month. The theme
was that “control is the antithesis of
improvement.” Although this pam-
phlet is far from the only publication
available that addresses this balance, I
always have considered it one of the
best sources for a brief discussion of
this all-important topic for quality
practitioners. The writings of Dr.
Joseph Juran, in particular, present
much more in-depth information on
this concept.
Fundamentally, it is important for
us to understand that sustainable
business success requires the ongoing
cyclical combination of periods of
breakthrough, where the focus is on
changing the process mean to achieve
more effective and efficient perfor-
mance (either for customers, for the
business, or for both) followed by
periods of incremental improvement
and control, where the focus is on sta-
bilization and variability reduction.
Lean and Six Sigma methods pri-
marily are associated with the incre-
mental improvement and control
phase of the process’s life cycle.
Although there are adaptations of the
Six Sigma process intended to be used
in association with the design of new
products, services and processes,
which often involve innovation, these
methods certainly are not intended to
be major factors in driving innova-
tion. On the other hand, the Six Sigma
methods certainly do not stand in the
way of innovation, either.
The key, of course, is to use Six
Sigma methods in conjunction with
other approaches to provide a com-
prehensive set of tools that create an
upward spiral of breakthrough and
incremental improvement, as
described by Dr. Juran. It appears that
8 I OCTOBER 2007 I www.asq.org
the BusinessWeek author, and quite
possibly the researchers and scientists
from 3M, had fallen into the famous
trap described by noted industrial
psychologist Abraham Maslow, “He
that is good with a hammer tends to
think everything is a nail.” Hopefully,
they’ll consider adding some tools to
their kit, so they can work with nuts,
bolts and other hardware, too.
Deborah Hopen
Deborah Hopen Associates, Inc.
Federal Way, WA
debhopen@nventure.com
Innovation Must Address
Business Goals
I have lived on both sides of the Six
Sigma for innovation fence. One
thing is certain: the discipline of design
for Six Sigma (DFSS) and the creativity
of raw innovation both have a rightful
place in many corporate environments.
The problem arises when the two are
mixed in the wrong manner. DFSS
essentially focuses on the correct pro-
jects done correctly; there are scores of
books describing great ideas that
enjoyed no sales and crummy ideas that
were executed flawlessly.
Conversely, raw innovation is very
important as well, but eventually
must be tied back to a business goal
(or two). One leaves invention for the
sake of invention to the universities.
Corporate innovation must have at
least some semblance of accountabili-
ty; the balance is difficult—but
rewarding—to achieve.
Proper (for profit) innovation rests
not on any one “methodology;” one
must take a holistic view of product
development.
The writer of the BusinessWeek article
was a typical journalist: seeing what he
wanted to see through his blinders.
Joe Finan
Genesis Innovation
jdfinan@genesis-innovation.com
Six Sigma Can Impede
Innovation
agree that Six Sigma can slow the
I pace of innovation when a compa-
ny has systemic weaknesses for evalu-
ating and implementing riskier ideas
that are essential for quick break-
throughs. If a risk averse corporate
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
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 QP
MAILBAG
culture only implements process
improvements through the deep div-
ing and consensus building exercise
that Six Sigma entails, innovation will
be slower. If companies are dependent
on quick high impact fixes, they may
have some brilliant innovations, but
the risk can be ruinous to their long-
term business plan. The most innova-
tive and successful corporations must
have systems that separately analyze
and accept the risk each of these two
disparate methods involves. The
foundation for business success usual-
ly comes down to what amount of
risk a corporate culture is willing to
accept and how they manage that
risk, not a single methodology in their
tool box.
Ed Cataldo
Diversified Machine
Bristol, IN
Practical Advice
On Youden Plot
K udos to Lynne B. Hare for writ-
ing an excellent and simple-to-
understand explanation of the Youden
Plot (Statistics Roundtable, August 2007,
p. 64). In the spirit of the article “It’s Not
Always What You Say, But How You Say
It,” I would suggest the term “expected
value” (center of the Youden circle) be
replaced with “consensus value” for
interlaboratory data, because it’s a term
that’s easily understood and commonly
accepted by industrial chemists as
opposed to a statistical expectation. Of
course, strictly speaking, to be statistical-
ly correct, the mode and not median
should be used to arrive at the “consen-
sus” value. However, the assumption
Mr. Pareto Head
10 I OCTOBER 2007 I www.asq.org
that the data isn’t bimodal or multi-
modal is a reasonable assumption, so the
median will likely suffice in more than
95% of the situations encountered.
Besides, use of the median will also
alert the analyst to bimodal data
because the plot will essentially have
two distinctly separate clusters lying
on the parity line.
I always enjoy reading Lynne’s arti-
cles because they’re so down to earth
and practical.
Alex Lau, CQE
Chairman, ASTM D02.94 Coordinating
Subcommittee on Quality and Statistics
Author’s Response
agree. In the specific case of the data
I in the example, though, I chose to use
the “known” value of the samples,
which were made up to a specific
Vitamin A content. Of course, in the
world of statistics, nothing is really
known. And in actuality, these samples
were subject to drift in value depending
on the date of analysis, which we tried to
keep constant. It is correct that the
“expected value” is not the best lan-
guage to use because it will be confused
with mathematical expectation. That, of
course, was not my intent.
Lynne B. Hare
Kraft Research
East Hanover, NJ
Case Study Confusing
ost statistical material pre-
M sented in QP is quite good,
but I found the case study article in
the August issue (“Retrospective
Analysis of a Designed Experiment,” p.
23) very confusing. How can Figure 4
(interactions) have any meaning if only
eight runs were conducted?
Or were additional runs carried
out—as implied by Table 3—to aug-
ment the original design in Table 2? If
so, what were the average F-50 val-
ues? And it seems highly unlikely
the stated results are “optimal.”
More careful proofreading should
also have addressed a number of quality
issues: for example, R is never defined
(same as F-50?), “experiment” is fre-
quently used instead of “runs,” etc.
Tom Doerfler
Doerfler.Thomas@TIAXLLC.com
Author’s Response
hese observations are relevant
T from the theoretical perspective
or in an experiment being conducted
in a perfect laboratory setting. One
has to analyze the whole issue in the
backdrop of knowledge level avail-
able at that time and place. The article
is about the retrospective analysis of
the experiment conducted in 1995 in
India. The knowledge level at that
time was Orthogonal Arrays and
empirical local knowledge. The inter-
action is always there between the
variables even in a single run. The
issue is that we cannot optimize.
Only eight runs were conducted. Yes,
the debatable issue is the level of res-
olution and the reliability of outcome.
The experiment never claimed to
achieve an ideal DoE solution—the
concluding part is relevant.
Bhupinder Yadav
by Mike Crossen
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make sense out of this

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KEEPING
CURRENT
INTERNATIONAL

ASQ Member Among Keynote Speakers

At Iran Conference
Grace Duffy, former vice president of ASQ, was a keynote
speaker at the recent 8th International Conference of Quality
Managers in Tehran, Iran.
Duffy was invited by Hesam Aref Kashfi, president of the
Iranian Society for Quality Managers, which sponsors the
conference. The two had met when Duffy represented ASQ
at the Turkish Quality Society’s 2006 conference in Istanbul.
After being asked to speak at the conference, Duffy was
concerned about traveling to a fundamentalist Islamic coun-
try with which the United States has an uneasy relationship.
To allay those concerns, her host, Kashfi, put her in touch
with people who had attended in 2006. ASQ past president
Chuck Aubrey, a keynote at the 2006 conference, was one of
those who assured her she would be well received and safe.
Getting there was a bit of a challenge, says Duffy, because
the United States has broken off diplomatic relations with
Iran. Pakistan’s embassy in Washington, DC, had to arrange
her visa, and the time-consuming process had to be initiated
by Kashfi. Once she arrived, however, it was smooth sailing.
“Not only was I well received at the Iranian conference,
but I was also treated like royalty,” Duffy says. “Many of the
attendees wanted to have their pictures taken with the
‘speaker from America’ and were eager to practice their
English, a language they learned in high school.”
While in Iran, Duffy respected laws of Islam and wore the
hijab, a headscarf to cover her hair, whenever she was in
SPEAKER FROM AMERICA: Duffy is shown during her
conference address in Iran.
public. She also received some tips on attire prior to the
trip—Kashfi sent her photos of professional women in
appropriate attire. “I and all the other professional women
who attended the conference were well received,” she says.
Despite scarce resources, the business community in Iran
is working to improve quality in products and services, ac-
cording to Duffy. “But there is a disconnect between the busi-
ness community and the current government of the
country,” she explains. “A good bit of infrastructure devel-
opment and construction is visible in Tehran, although pro-
ject management of these ventures
does not appear to be well orga-
nized.”
Duffy reports the conference
was well designed, with interest-
ing technical content and exhibits.
“The Iranian business community
is very strong,” she says. “The
4,237 attendees represented a
broad base of individuals from 36
countries. It was truly an interna-
tional event.”

SIGHTSEEING: Duffy visited

archaeological ruins at Persepolis
during her visit to Iran.

12 I OCTOBER 2007 I www.asq.org

ASQ
ASQ Launches Free
Healthcare Quality Webinars
Issues related to healthcare quality and delivery will be
the focus of a new series of four sponsor supported semi-
nars offered via the web by ASQ.
The first, “Measure, Manage, Monitor, and Improve:
Case Study on Improving Hand Washing Compliance,” is
scheduled for 1-2 p.m. CST, Wednesday, Oct. 10. It is spon-
sored by Statit Software.
During the webinar, Colleen O’Brien, quality resource
team leader at Bellin Hospital in Green Bay, WI, will dis-
cuss the process Bellin underwent while preparing for a
visit from the Joint Commission on Accreditation of
Healthcare Organizations.
Each webinar in the ASQ series will last one hour and
will include a 45-minute presentation followed by 15 min-
utes of Q&A. Future topics will include: establishing and
tracking effective measures; Six Sigma basics; the plan-do-
study-act cycle; failure mode effects analysis and value
added analysis.
Healthcare professionals can register for the free webi-
nar or learn about future programs in the series at www.
asq.org/healthcareqps/index.html.
ASQ
Team Competition
Judging Starts
The International Team Excellence Award judging
begins this month. Finalists will be notified of their
selection Dec. 3. The live final round of competition
will be featured during next year’s ASQ’s World
Conference on Quality and Improvement May 5-7 in
Houston.
ASQ members from the United States and across
the globe responded to a recent call for team com-
petition judges. The 334 applications came from
Argentina, Brazil, Canada, China, Costa Rica, Dubai,
Egypt, India, Italy, Iran, Mauritius, Mexico, the
Philippines, New Zealand, Saudi Arabia, Trinidad
and Tobago, and the United Kingdom.
This year’s simplified team competition application
process allowed online uploading of entry materials.
Access a detailed timeline of the process and other
information at http://wcqi.asq.org/team-competition/
index.html.
C A P I TA L Q
ASQ Tells Congress
Inspection Not the Answer
ASQ recently warned Congress that increased
inspection is not the answer to growing food safe-
ty concerns.
In a written statement to the House of
Representatives’ committee on energy and com-
merce’s subcommittee on oversight and investi-
gations, Paul Borawski, ASQ’s executive director
and chief strategic officer, said, “Congress and the
FDA [Food and Drug Administration] should be
wary of the drumbeat calling for more inspection,
as this is a complex situation and an expensive
approach that cannot work.”
According to ASQ’s statement, the subcommit-
tee should focus on other areas in its assessment
of the FDA’s ability to ensure safe food, including:
• System and process.
• Supply chain management.
• An international data system for traceability.
• Joint agency activities to reduce fragmented
oversight.
• Government/industry partnerships to focus
on weak areas.
• Labeling to identify foods treated with carbon
monoxide.
• Implementation of the Institute of Medicine’s
recommendations in a 2003 report,
“Scientific Criteria to Ensure Safe Food.”
• Congressional and Health and Human
Services Department support and funding of
past FDA proposals that have demonstrated
innovative approaches to food safety.
To view ASQ’s full statement, visit www.asq.
org/about-asq/what-we-do/issues-actions/
20070817-food-safety.html. ASQ also discussed
specific food safety issues in its most recent
“Quarterly Quality Report,” which can be found at
www.asq.org/quality-report/index.html.
QUALITY PROGRESS I OCTOBER 2007 I 13
KEEPING
CURRENT
short
runs THE LATEST UPDATE of
the online Quality Compass,
published by the National
Committee for Quality
Assurance, includes com-
parative performance information on several new mea-
sures of care and service for commercial health plans.
Notable among the new measures are those that look at
how well medications are managed. For details, go to
http://web.ncqa.org/tabid/522/default.aspx.
Web Watch
Along with food safety and medical devices—the subject of feature articles in
this issue of QP—toy recalls have been a hot media topic recently. So, this
month’s Web Watch focuses on quality in all three of these areas.
FOOD SAFETY
www.asq.org/fdc
ASQ’s Food, Drug and Cosmetics Division
recently developed a new Certified HACCP [Hazard
Anal-ysis and Critical Control Point] Handbook.
The division’s website provides updates on other
ac-complishments, programs, events and courses.
www.cfsan.fda.gov/list.html
The site of the Food and Drug Administration’s
(FDA’s) Center for Food Safety and Applied Nutri-
tion is filled with information and links pertaining
to recent media coverage, national food safety
programs, documents, food defense and terror-
ism, inspection, compliance, recalls, and HACCP.
www.foodsafety.gov
This website brings together food safety infor-
mation from several different federal departments
and agencies, including the Centers for Disease
Control and Prevention, the Environmental
Protection Agency, the FDA’s Food Safety and
Inspection Ser-vice, and the Partnership for Food
Safety Educa-tion, known as Fight Bac.
www.iso.org/iso/iso_catalogue/management_
standards/specific_applications.htm#food
The International Organization for Standardiza-
tion (ISO) now offers three documents related to
food safety: ISO 22000:2005 (a standard contain-
ing requirements for food safety management
systems); ISO/TS 22004:2005 (a standard with
requirements for entities providing audit and cer-
tification of food safety management systems);
and ISO/TS 22004:2005 (guidance for using ISO
14 I OCTOBER 2007 I www.asq.org
SEVEN LEADING RETAILERS, including Wal-Mart, have
agreed to rely on certified food safety and quality manage-
ment systems for production, preparation, transport, stor-
age and handling. For details about this and the global
food safety initiative, go to http://web.ansi.org/news_
publications/news_story.aspx?menuid=7&articleid=1562.
THE INTERNATIONAL ORGANIZATION FOR STAN-
DARDIZATION recently issued ISO/TR 27809, a technical
report aimed at reducing the number of patients harmed
22000:2005). Links to information on the docu-
ments are provided on this website.
MEDICAL DEVICES
www.iso.ch/iso/en
ISO also offers three documents related to med-
ical devices: ISO 13485:2003, a standard covering
quality management system requirement for regu-
latory purposes; ISO/TR 14969:2004, which provides
guidance of applying ISO 13485; and Guide 63:1999
on inclusion of safety aspects in standards for med-
ical devices. ISO’s search engine can be used to find
information on each of these documents.
TOY SAFETY
www.astm.org
While ISO 9001 can be used to develop quality
management systems for toy manufacturing,
ASTM International is publisher of most of the
product standards on toy safety, including ASTM
F734-84, which focuses on risk based safety
assessments. Using the word “toy,” the site’s
search engine can lead visitors to information and
news items about these standards.
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.
Found an interesting quality site? If you
come across a noncommercial site that
could be useful to other quality profes-
sionals, e-mail it to sdaniels@asq.org.
by the misuse or malfunction of healthcare software.
The report says standards, including those related to
quality and risk management, should be used for the con-
ception, design, production and deployment of health
software. For more information, go to www.iso.org/iso/
pressreleases.htm?refid=Ref1068 (case sensitive).
THE NATIONAL INSTITUTE OF STANDARDS AND
TECHNOLOGY’S new calibration service for phasor mea-
surement units provides calibrations for the instruments
that measure the magnitude and phase of voltage and
current signals in a power system. The data is reported in
terms of coordinated universal time, also known as the
official world atomic time. For more information, go to
www.nist.gov/public_affairs/techbeat/tb2007_0816.htm.
ISPE, a society of pharmaceutical manufacturing pro-
fessionals, has released the ISPE Good Practice Guide:
Development of Investigational Therapeutic Biological
Products. It is designed as a one-source document for
pharmaceutical professionals looking for initial guidance
on planning, production, packaging, distributing and fil-
ing considerations for biologics. For information, go to
www.ispe.org.
THE AUTOMOTIVE INDUSTRY ACTION GROUP has
issued new guidelines aimed at improving auto parts
quality. The guidelines assist in meeting standard audit
requirements for heat treat, coatings and plating process-
es for parts such as seat belts, steering gears and interior
and exterior painted parts. They are available for pur-
chase at www.aiag.org.
ASQ
Nominations Sought for
President-Elect, Treasurer
And National Director
The ASQ nominating committee is currently accepting
applications for president-elect (three-year progression
through president and chair), treasurer (one-year term) and
national director (two-year term). Terms for all positions
will begin July 1, 2008. Nomination applications can be sub-
mitted through Oct. 15.
After logging on as a member at www.asq.org, go to
“ASQ Seeks Candidates for its Board of Directors” at the
bottom of the page to find requirements and details on the
nomination process, applications, policies and other sup-
porting information. Contact Karla Reisinger at 800-248-
1946 x7253 or kriesinger@asq.org with any questions.
Q
W h o ’s Who in
Name: Tim Solso
Residence: Indianapolis
Education: Bachelor’s degree in psychology
from DePauw University, Greencastle, IN; MBA
from Harvard.
Current job: CEO and chair-
man, Cummins Inc.; has been
with Cummins since 1971.
Quality connection: Six Sigma
was launched at Cummins in
early 2000, the same time
Solso became chair and CEO.
ASQ connection: Cummins is one of ASQ’s first
organizational members.
Recent honors and achievements: Named Six
Sigma CEO of the year by the Worldwide
Conventions and Business Forum’s Global Six
Sigma Awards; chaired the recent U.S. represen-
tation at the U.S.-Brazil CEO Forum; named one
of the top 100 corporate citizens in the United
States for the last eight years and No. 1 in 2005
by CRO [corporate responsibility officer] maga-
zine; one of Cummins’ first belt trainees.
Personal: Married; three grown children and
two young grandchildren.
Favorite ways to relax: Fishing; spending time
with his family.
Quality quote: Six Sigma has changed the way
Cummins approaches problem solving and quali-
ty improvement efforts. We have worked hard to
make Six Sigma a part of our DNA at Cummins.
It has played a key role in the company’s turn-
around in the past few years by helping us cut
costs, strengthen our processes and more quick-
ly improve the quality of our products and ser-
vices.
QUALITY PROGRESS I OCTOBER 2007 I 15
KEEPING
CURRENT

ASQ

Education Conference to Feature Team Excellence Award

The 15th annual National Quality
Education Conference (NQEC) will
be held Nov. 11-13 in St. Louis. The
conference will feature its first Team
Excellence for Education Award, with
live presentations by teams from both
higher education and K-12 school dis- of No Person Left Behind:
tricts. Leading With and to Meaning,
Three keynote speakers are also will discuss how educators can
scheduled for NQEC: become catalysts for change.
• Alex Pattakos, a principal with • Ian Jukes, director of the Info
the Innovation Group and author Savvy Group, will explore learn-
ing strategies of high-tech stu-
dents and provide new teaching
strategies for the digital genera-
tion.
• Cyndi Laurin, author of Catch!
A Fishmonger’s Guide to
Greatness and founder of Guide
to Greatness LLC, will present
creative ways teachers can
inspire greatness in students.
This year’s NQEC will feature 40
sessions, five half-day workshops and
scheduled networking opportunities.
For more information on the event
and registration, go to http://nqec.asq.org.

ProFicient is InfinityQS’ latest release

TM

of its industry-leading SPC software with

new features and enhancements. ASQ News
ENERGY AND ENVIRONMEN-
ProFicient automates data collection and analysis on the plant
TAL CONFERENCE IN NOVEM-
BER The 34th National Energy
floor, helping operators and quality professionals make intelligent and Environmental Conference
decisions to improve their processes in real-time, dramatically will take place Nov. 4-7 in
reducing scrap and rework. This software release offers new Providence, RI. The event is co-
sponsored by the Energy and
features and upgrades including Job Controlled Data Entry, Environmental Division and the
Hierarchical Corporate Grouping, a Performance Buffer, increased Design and Construction
database security, support of ANSI/ISA 95 Requirements, Division. There will be several
speakers, a postconference ses-
and many other enhancements. For more information and a
sion and 22 technical sessions,
free trial CD, call 1-800 -772-7978. including a track on nuclear
power. Registration materials,
Efficient manufacturing. ProFicient software. along with program and speaker
information, can be found at
www.asq.org/ee.

2008 SIX SIGMA CONFER-

ENCE SCHEDULED Planning is
www.infinityqs.com 1.800.772.7978
underway for the 8th Annual Six
Sigma Conference Feb. 11-12 at

16 I OCTOBER 2007 I www.asq.org

EDUCATION

Higher Education Community Studies Quality 101

Members of ASQ’s new Higher ment; in-depth measuring tech- ductory quality
Education Community were recently niques; survey design; the balanced courses, visit the
surveyed about what they believe to scorecard; and process participant education community
be the critical components of an intro- roles, such as HR, suppliers or part- at www.asq.org/
ductory quality course. The survey is nerships. members/communities/
part of a study being conducted by To read more about this and par- higher-education/
the community. ticipate in a discussion about intro- index.html. QP
Topics at the top of the list of
responses included:
• Basic definitions of quality.
• An overview of some quality
models.
• An overview of quality’s histo-
ry.
• The importance and definition
of variation.
• Focus on the customer.
• Cost of quality.
Respondents listed the use of
case studies, best practices and
class activities—preferably using
real business data—as important.
On the other hand, areas the
respondents considered too
advanced for an introduction to
quality include steps and require-
ments for total quality manage-

the Pointe Hilton Tapatio Cliffs

Resort in Phoenix. For more
details and updates, go to
www.asq.org/conferences/six-
sigma/index.html.

OTT SCHOLARSHIPS PRE-

SENTED The 2007-08 recipients
of the Statistics Division’s Ellis R.
Ott Scholarship for applied sta-
tistics and quality management
are Michelle Quinlan of the
University of Nebraska, Lincoln,
and Shannon Fraker of Virginia
Tech. Both are in the doctorate
category. Applications for the
2008-09 year are now available
at www.asqstatdiv.org and will
be accepted between Jan. 1 and
April 1, 2008. For more informa-
tion, contact Lynne B. Hare at
lynnehare@patmedia.net.

QUALITY PROGRESS I OCTOBER 2007 I 17

 Advance Quality
in Higher Education

ASQ’s Higher Education Community allows you

to access and contribute to:
• MATERIALS AND CURRICULUM: Faculty are teaching quality
within their courses and have developed materials and
curriculum that other higher education professionals would
benefit from. Share materials you have developed or are
using and view examples from others.
• CASE STUDIES/ARTICLES: ASQ has a growing body of
knowledge, including case studies and articles, around higher
education. You can use these case studies in your class or
offer a case study of your own to the rest of the community.
• HOT ISSUES: A number of hot issues are being discussed in
higher education right now and quality can play a role in the
solution. Members of the community have the opportunity to
discuss these topics, learn from each other, and join together
to be part of the solution.
• ADVISORY COMMITTEE: A higher education advisory
committee has been formed to oversee developments in the
areas of higher education and ASQ’s role. These members
are a reference to you in your journey.
• EVENTS: Events, whether face-to-face or virtual, can help
quality professionals come together. ASQ offers an area to
share planned events, or you can submit an idea for an event
for ASQ to plan that will help keep this community connected.
• PRODUCTS/SERVICES: ASQ has a number of courses,
certifications, publications, books, and other products that
serve the higher education community. This community can
share what ASQ products have been beneficial to them as
well as recommend new products or services.

Get Involved
ASQ MEMBERS CAN LEARN MORE OR JOIN THE COMMUNITY AT www.asq.org/HEC.

Priority Code EDHFB18

FOOD SAFETY
A Recipe for Safe
Food: ISO 22000
and HACCP
by John G. Surak
F
ood safety experts insist that the U.S. food
supply is one of the safest in the world.
However, the Centers for Disease Control
and Prevention (CDC) estimate that more than
76 million people get sick from food related ill-
nesses each year.1 This results in more that 300,000
In 50 Words
Or Less
• Three recent major recalls highlight the
importance of food safety, particularly in
a global food chain.
• ISO 22000 incorporates and strengthens the
hazard analysis and critical control point
system to create an effective food safety
management system.
• It is designed for the entire chain, starting
with producers.
hospitalizations and 5,000 deaths.
Recently, there have been several high profile
food recalls. These incidents include three national
recalls: spinach contaminated with a pathogenic
strain of E. coli, peanut butter contaminated with
Salmonella, and tainted pet food.
In the spinach incident, 199 people in 28 states
were infected. As a result, 141 individuals were
hospitalized, 31 developed a type of kidney failure,
and three died.2
When tainted peanut butter turned up on store
shelves, 425 people were infected with Salmonella,
and 71 of them were hospitalized. This contamina-
tion produced no known deaths.3
The tainted pet food recall began this May and
involved a long list of both store and major brands
containing melamine in product imported from
China. The exact number of deaths is unknown, but
it has been estimated that more than 20 pets died.
It can be estimated that more than 1 billion meals
are consumed each day in the United States, and
each meal contains multiple opportunities to con-
sume a food safety hazard like pathogenic bacteria.
These statistics are further influenced by changes
in the dietary patterns of Americans. They are con-
suming fresher and minimally prepared foods. The
QUALITY PROGRESS I OCTOBER 2007 I 21
FOOD SAFETY
typical preparation process for these foods
might not remove or destroy all pathogens
that could be present. In addition, the consoli-
dation and globalization of the food industry
has allowed Americans to consume these pro-
ducts year-round rather than in season. Thus,
if there is a food safety incident, it will affect
more consumers.
As a result, serious questions are raised:
• How can food supplies remain safe in a
global environment?
• How can the food system be improved?
Ensuring safe food is a responsibility of
everyone in the food chain. Food safety starts
on the farm, continues with the food manufac-
turers and distributors, and ends with the con-
sumer (see Figure 1).
HACCP
Hazard analysis and critical control point
(HACCP) is an effective tool to prevent food
from being contaminated. HACCP is not a new
concept. The Pillsbury Co. developed it for
NASA in the late 1950s to prevent food safety
TABLE 1 Five Preliminary Steps
And Seven Principles of HACCP
Step Description
Preliminary step one Assemble the HACCP team.
Preliminary step two Describe the product.
Preliminary step three Identify intended use of the product.
Preliminary step four Construct a flow diagram.
Preliminary step five Conduct an on-site verification of the flow diagram.
Principle one Conduct a hazard analysis.
Principle two Determine critical control points (CCPs).
Principle three Establish critical limits for CCPs.
Principle four Establish a monitoring system for CCPs.
Principle five Establish corrective actions.
Principle six Establish verification procedures.
Principle seven Establish documentation and recordkeeping.
22 I OCTOBER 2007 I www.asq.org
FIGURE 1 Food Chain
Suppliers
Food producers Pesticides fertilizers
and veterinary drugs
Food manufacturers Ingredients and
food additives
Wholesalers Equipment
Regulatory
agencies Distributors Cleaning and
sanitizing supplies
Food Packing
Retailers
service Other services
Consumers
Adapted from ISO 22000:2005, Food Safety Management
Systems—Requirements for Any Organization in the Food
Chain, International Organization for Standardization, 2005.
incidents on manned space flights (see “HACCP in
a Nutshell”).
The original concept of HACCP consisted of
three principles:4
1. Identify and assess hazards associated with
food, from growing to marketing.
2. Determine critical control points (CCPs) to
control any hazard.
3. Establish a system to monitor CCPs.
As various food safety practitioners implement-
ed these concepts, HACCP evolved from the
original three principles to five preliminary
steps and seven principles listed in Table 1
that are supported by prerequisite programs
(PRPs) detailed in Table 2.
The first U.S. HACCP standard was pub-
lished in 1989 by the National Advisory
Committee on the Microbiological Criteria
for Foods and was revised in 1992 and 1997.
In 1993, the Codex Alimentarius Commission
published the first international HACCP
standard, which was revised in 1997.
Both of these are guidance standards,
rather than auditable standards. They are
designed to help organizations implement
HACCP.
HACCP has been slowly incorporated into
the food safety system. In the early 1970s, the
Food and Drug Administration (FDA) incor-
porated HACCP principles into the regulations
that govern the production of low acid canned
foods. These regulations have successfully pre-
vented outbreaks of foodborne disease caused by
Clostridium botulinum toxin in commercially
canned foods.
In 1985, the Food Protection Committee of the
National Academy of Sciences issued a report
stating that HACCP was the most effective sys-
tem for ensuring the safety of the food supply.5
As a result, U.S. regulatory agencies incorpo-
rated HACCP requirements into the regulations
that govern the processing of red meats (pri-
marily beef and pork), poultry (primarily chicken
and turkey), fruit and vegetable juices, and sea-
food.
As of Jan. 1, 2006, the European Union man-
dated all food manufacturing facilities that
produce food for the European market to incor-
porate HACCP into their food safety systems.
Starting in the 1990s, various customers in the
food chain required their suppliers to have certi-
fied HACCP systems. Therefore, a number of
countries, including Australia, Denmark,
Germany, Ireland, the Netherlands and the
United States, developed auditable national food
safety management standards (FSMSs).
In addition, some private organizations devel-
oped standards. The national and private stan-
dards provided auditable standards that could be
used for third-party certifications. All of these
TABLE 2 Prerequisite Programs
Prerequisite programs (PRPs) provide the foundation for hazard
analysis and critical control point (HACCP) to function. Food safety
experts have found that well-functioning PRPs simplify and
strengthen the HACCP plan. The PRPs are based on good manufac-
turing practices or good hygienic practices.1
PRPs include:
• Facilities, including construction and layout of buildings, asso-
ciated utilities, premises, workspace and employee facilities.
• Supporting utilities including air, water and energy.
• Supporting services including waste and sewage disposal.
• Suitability of equipment and accessibility of equipment for
cleaning and maintenance.
• Management and control of purchased materials.
• Prevention of cross contamination.
• Cleaning and sanitizing.
• Pest control.
• Personal health and hygiene.
• Environmental monitoring.
• Chemical control.
• Glass and hard plastic control.
• Product trace and recall.
• Complaint investigation.
• Labeling.
• Employee training and competencies.
REFERENCE
1. V.N. Scott and K. E. Stevenson, HACCP—A Systematic Approach to Food Safety,
Food Products Assn., 2006.

HACCP in a Nutshell
Hazard analysis and critical control point (HACCP) is a food safety system designed to prevent
biological, chemical and physical hazards in food.
The process starts with identifying the food safety hazards most likely to occur in a specific food
product manufactured by a specific process. Next, the food safety team determines the likelihood of
occurrence of the hazard and its severity.
Hazard analysis has the same roots as failure mode effects analysis. A strategy is developed to
prevent the occurrence of the food hazards by controlling the environment and processes that keep
food safe. The strategy is summarized in the HACCP plan.
The success of a food safety management system depends on ensuring a safe environment to
produce food, implementing a proper HACCP program and having management commitment to
food safety and the HACCP approach. —J.S.

QUALITY PROGRESS I OCTOBER 2007 I 23

FOOD SAFETY

TABLE 3 General Structure of ISO 22000:2005

Element Description
4 Food safety management system
4.1 General requirements
Documentation requirements:
4.2 • Control of documents
• Control of records
standards and audit programs are similar 5 Management responsibility
but vary slightly . 5.1 Management commitment
5.2 Food safety policy
Addition of ISO 22000 5.3 Food safety management system planning
5.4 Responsibility and authority
An international effort developed to har-
5.5 Food safety team leader
monize the food safety standards into a Communications
single International Organization for Stan- 5.6 • External
dardization (ISO) standard. ISO 22000— • Internal
5.7 Emergency preparedness and response
Food Safety Management Systems—Require-
Management review
ments for Any Organization in the Food Chain6 5.8 • Review input
was published in 2005 (see Table 3). • Review output
6 Resource management
The standard defines a state-of-the-art
6.1 Provision of resources
FSMS as having the following characteris- Human resources
tics: 6.2 • Competence, awareness and training
• Can be used by all organizations in the 6.3 Infrastructure
food chain. 6.4 Work environment
• Incorporates the five preliminary steps 7 Planning and realization of safe products
7.1 General
and seven principles of HACCP.
7.2 Prerequisite programs
• Provides an auditable standard that Preliminary steps to enable hazard analysis
can be used as part of third-party certi- • Food safety team
7.3 • Product characteristics
fication. • Intended use
• Ensures that the process to control food • Flow diagrams, process steps and control measures
safety is validated, verified, imple- • Hazard analysis
7.4 • Hazard identification and determination of acceptable levels
mented, monitored and managed. • Hazard assessment
• Focuses only on food safety. • Selection and assessment of control measures
ISO 22000 strengthens the HACCP sys- 7.5 Establishing the operational prerequisite programs
Establishing the hazard analysis and critical control point (HACCP) plan
tem in several ways. It is a management • Identification of critical control points
standard; therefore, it shares the following 7.6 • Determination of critical limits for critical control points
• System for the monitoring of critical control points
common elements with other management • Actions when monitoring results exceed critical limits
system standards: Updating of the preliminary information and documents specifying the
7.7 prerequisite programs and the HACCP plan
• Policy.
• Planning. 7.8 Verification planning
7.9 Traceability system
• Implementation and operation.
Control of nonconformity
• Performance assessment. • Corrections
• Improvement. 7.10 • Corrective actions
• Handling of potentially unsafe products
• Management review. • Withdrawals
The standard is fully compatible with 8 Validation, verification and improvement of the food safety management
other ISO management system standards system
8.1 General
such as ISO 9001. However, there are differ-
8.2 Validation of control measure combinations
ences between the two standards. 8.3 Control of monitoring and measuring
The focus of ISO 9001 is quality, while the Food safety management system (FSMS) verification
focus of ISO 22000 is food safety. ISO 22000 8.4 • Internal audit
• Evaluation of individual verification results
assumes a food product exists alongside a • Analysis of results of verification activities
process to manufacture that product. This Improvement
includes having an effective purchasing sys- 8.5 • Continual improvement
• Updating the FSMS

24 I OCTOBER 2007 I www.asq.org

tem and a product quality assurance system. In addi-
Food Safety
tion, there are small differences in the organizational
structure between the two standards.
In the Home
Other additions to ISO 22000 beyond ISO 9001
include: Most consumers believe the primary cause of
• No exclusions in the requirements are permitted. foodborne illness is unsafe food handling practices
• The FSMS must conform to appropriate statuto- in food processing plants or restaurants.
ry and regulatory requirements.
In contrast, most food safety experts believe the
• The organization must demonstrate that food
safety is supported by the business objectives. biggest source of foodborne illness is unsafe food
• The organization must develop an emergency handling practices in the home. Therefore, food
preparedness procedure. safety is also the responsibility of individuals who
• The infrastructure or prerequisite programs
prepare food in the home.
(PRPs) needed for a FSMS are defined in detail.
These programs provide the environment for the The Partnership for Food Safety Education is an
production of safe food. association of industry, government and academia
• PRPs are recognized as being managed in differ- with a mission to educate the public on safe food
ent ways. For example, different protocols are
handling practices. This partnership developed the
needed to implement and maintain training and
competencies, facilities, cleaning and sanitation, Fight BAC (Fight Bacteria) program.1
and personal hygiene. Fight BAC consists of the following four princi-
• Analysis for food safety hazards must be con- ples:
ducted as a part of the process for planning the
1. Clean: Wash hands and food preparation sur-
safe realization of food production.
• There is an assumption that it is possible for an faces often.
unsafe product to enter the food chain; therefore, 2. Separate: Do not
organizations must have recall or product with- create an environ-
drawal procedures.
ment in which
• The traceability system requires organizations to
trace all ingredients and components for food potentially patho-
products from the immediate suppliers through genic bacteria can
the manufacturing processes. In addition, it spread through
requires the traceability of end products to the
cross contamination.
immediate customers.
• If the organization produces an unsafe product, 3. Cook: Cook all foods
the hazard must either be eliminated or reduced to the proper tem-
to an acceptable level before the product enters perature.
the food chain.
4. Chill: Chill food
• Concessions cannot be made if the product is
unsafe or contains a food safety hazard. quickly because cold
ISO 22000 does not have a requirement for a pre- temperatures slow
ventive action procedure. HACCP is inherently a sys- the growth of all
tem to prevent food safety hazards. However, ISO
bacteria, including pathogenic bacteria. —J.S.
22000 recognizes that new food hazards emerge and
new technologies are developed to control food safety
REFERENCE
hazards. Therefore, ISO 22000 uses a systems 1. Partnership for Food Safety Education, Fight BAC program,
approach (continual updating of the FSMS) to prevent www.fightbac.org.
new hazards from occurring in the food products.
When compared with other food safety standards,
ISO 22000 strengthens a number of the management
related elements with the following:
• The organization must first effectively plan for

QUALITY PROGRESS I OCTOBER 2007 I 25

FOOD SAFETY

ASQ’s Food, Drug and

Cosmetic Division
ASQ’s 5,600-member Food, Drug and Cosmetic (FDC) Division published the new Certified HACCP
[hazard analysis and critical control point] Auditor Handbook through ASQ Quality Press this spring.
The division is also currently in the process of developing a new pharmaceutical certification called
certified pharmaceutical good manufacturing compliance professional, or CPgmpCP. It also is working
with other divisions on a risk management book.
June M. Morita of Prospect Heights, IL, is chair of the division, and Diane G. Kulisek of Simi Valley,
CA, is chair elect. The Midwest Conference on Feb. 20, 2008, is the FDC Division’s next major event.
Additional information on the division, its activities and accomplishments can be found at
www.asq.org/fdc/index.html. —Susan E. Daniels, editor at large

the realization of safe food and then imple-
ment the plans to ensure the production of
safe food.
• The standard requires that food safety be
supported by the organization’s business
objectives.
• The standard defines the inputs and outputs
to the senior management review process.
• The standard strengthens the internal and
external food safety communication require-
ments.
• The standard requires the development of an
emergency response procedure.
• The standard requires that responsibilities of
the food safety team leader (traditionally the
HACCP coordinator) be expanded to include
continual management of the FSMS, manag-
ing the food safety team and reporting to top
management on the status of the FSMS.
• The standard requires the training element be
strengthened to include competencies.
• The standard requires PRPs to be verified.
• The standard formally accepts that an FSMS
might not have a CCP.
• The standard requires continual improvement
and updating of the FSMS.
ISO 22000 is designed to be used by any organi-
zation in the food chain, including producers, sup-
pliers, manufacturers, distributors, retailers and
food service organizations.
Using Other ISO Standards
ISO technical committee 34, which deals with food
products, recognized the need to ensure a creditable
certification process for FSMSs. Thus, technical com-
mittee 34 and the ISO Committee on Conformity
Assessment developed a standard that defines the
requirements of accreditation bodies, certification
bodies and auditors that will be involved in the ISO
22000 certification process.
On Feb. 15, 2007, ISO published TS 22003:2007,
Food Safety Management Systems—Requirements for
Bodies Providing Audit and Certification of FSMSs.7
The working group intends to use ISO 22003, ISO
170218 and ISO 190119 to define the fundamental
principles for the accreditation, certification and
auditing processes for ISO 22000 certification.
ISO TS 22003 defines the specific competency
requirements FSMS auditors must demonstrate in
the following areas:
• Management system audits.
• Applicable laws and regulations.
• HACCP and food safety, including the
identification and evaluation of food safety

26 I OCTOBER 2007 I www.asq.org

 hazards linked to the supply chain.
• Methods to determine, implement and man-
age control measures for HACCP plans and
PRPs.
• Knowledge of products, processes and prac-
tices in the food sectors they will audit.
The food chain is quite diverse. Thus, different
technical competencies are needed to conduct food
safety audits. It will be unlikely any one auditor
will be able to effectively demonstrate competency
in all areas of the food chain.
Strengthening Food Safety
The Institute of Medicine of the National Acade-
my of Sciences10 convened a special committee to
develop recommendations to Congress and the
two national agencies that regulate the production
of food: the FDA and the FDA’s Food Safety and
Inspection Service. The recommendations include:
• Food safety regulatory agencies must contin-
ue to emphasize prevention, reduction or
elimination of foodborne disease hazards.
• HACCP plans that are specific to a product
and a processing line should be developed.
• Statistical process control linked to continu-
ous improvement must be a part of food safe-
ty regulations. The concept of continuous
improvement is central to food safety.
• Imported produce should follow the same
good agricultural practices required for
domestic produce.
• Microbiological samples provide organiza-
tions and the regulatory agencies with a score-
card of performance. Future significant gains
in the safety of the U.S. meat and poultry sup-
ply can be realized only by implementing
more effective process control measures.
• The U.S. food processing industry must move
from an inspection based system to a process
control based one to ensure the production of
safe food.
The report makes additional recommendations
to improve the regulations governing the safety of
seafood, dairy products, fruits and vegetables. In
addition, it makes specific recommendations for
improving the process used for disease surveillance
and monitoring microbial contamination of food.
U.S. consumers expect their food supply to be
safe. ISO 22000 strengthens HACCP by linking the
plan to PRPs and defining management’s respon-
sibilities.
REFERENCES
1. Centers for Disease Control and Prevention (CDC),
www.cdc.gov/foodsafety.
2. CDC, www.cdc.gov/ecoli/2006/september/updates/
100606.htm.
3. CDC, www.cdc.gov/ncidod/dbmd/diseaseinfo/
salmonellosis_2007/outbreak_notice.htm.
4. V.N. Scott and K. E. Stevenson, HACCP—A Systematic
Approach to Food Safety, Food Products Assn., 2006.
5. Ibid.
6. ISO 22000:2005—Food Safety Management Systems—
Requirements for Any Organization in the Food Chain, ISO, 2005.
7. ISO TS 22003: 2007—Food Safety Management Systems—
Requirements for Bodies Providing Audit and Certification of Food
Safety Management Systems, ISO, 2007.
8. ISO/IEC 17021:2006—Conformity Assessment—
Requirements for Bodies Providing Audit and Certification of
Management Systems, ISO, 2006.
9. ISO 19011:2002, Guidelines for Quality and/or
Environmental Management Systems Auditing, ISO, 2002.
10. National Academy of Sciences, Scientific Criteria to
Ensure Safe Food, National Academies Press, 2003,
www.nap.edu/catalog/10690.html?se_side.
BIBLIOGRAPHY AND NOTE
ASQ Certified HACCP Auditor, www.asq.org/certification/
haccp-auditor/index.html.
Food Safety Gateway, www.foodsafety.gov. This site pro-
vides links to food safety organizations.
JOHN G. SURAK is the principal of
Surak and Associates, which provides
consulting for food safety and quality
management systems, designing and
implementing process control systems,
and implementing Six Sigma and busi-
ness analytics systems. Surak is a
fellow of ASQ and an ASQ certified quality engineer, man-
ager of quality/organization excellence, quality auditor and
HACCP auditor. He is the ASQ standards committee liai-
son from the Food, Drug and Cosmetics Division.
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.
QUALITY PROGRESS I OCTOBER 2007 I 27
SIX SIGMA
Achieve
Compliance
Through CI
by Alan F. Chow, Ronald Bowman and Leonard C. Wittenberg
In 50 Words
Or Less
• Six Sigma’s continuous improvement
philosophy and tools can support efforts
to meet FDA requirements.
• Optical Integrity Inc., a medical device
manufacturer, used the define, measure,
analyze, improve and control process to
comply with regulations.
• This achievement showcases the synergy
that’s possible between continuous
improvement and current good manufacturing
practice requirements.
28 I OCTOBER 2007 I www.asq.org
ompliance with regulatory requirements
C takes planning, understanding and com-
mitment. For medical devices, the Food
and Drug Administration (FDA) has established
laws and regulations. Many other countries have
either adopted the ISO 9001 requirements or
developed their own similar regulations for med-
ical devices.
Continuous improvement using Six Sigma tools
is a time proven operating philosophy used by
General Electric, Motorola, Allied Signal and a host
of other successful corporations. The Six Sigma
operating philosophy can be a method for meeting
and exceeding regulatory requirements.
Many see a conflict between having a strong and
encompassing quality management system and a
dedication to continuous improvement.1 But the
requirements encoded in the FDA concept of cur-
rent good manufacturing practice (cGMP) and ISO
9001 requirements can dovetail perfectly with the
Six Sigma continuous improvement operating phi-
losophy.
 The requirements of cGMP cover the entire orga-
nization, including:
• Management responsibility and commitment.
• Benchmarking and best practices.
• Design of products and processes.
• Employee skills and training requirements.
For each of these areas, Six Sigma continuous
improvement can support the regulatory compli-
ance efforts, and a compilation of Six Sigma tools
will help meet those requirements. Optical Integrity
Inc., a company that develops and manufactures
minimally invasive medical devices such as fiber
optic cables used in urology or vascular procedures,
used the define, measure, analyze, improve and
control (DMAIC) process to comply with medical
device regulations. This manufacturer’s achieve-
ment showcases the synergy that can exist between
continuous improvement and cGMP requirements
Detailed Documentation
Most regulated industries share similarities in
requirements for a compliant quality system. Such
basic requirements are not much different from
implementing an ISO 9001 system, but the devil is
in the details.
Expectedly, regulated industries tend to have far
more required details in their systems than compa-
nies in less regulated or unregulated commercial
industries. Implementing a solid Six Sigma philos-
ophy and system of continuous improvement will
require a system of tracking, measuring and
improving every aspect of the operation.
When developed with the regulatory require-
ments in mind, the documentation of a Six Sigma
system will provide a viable recording system of
all processes, products and systems in the organi-
zation. Accordingly, this helps the organization
meet the documentation requirements.
Management Responsibility
And Commitment
A solid Six Sigma system requires that manage-
ment play the same proactive and participative
role as required with cGMP. The first part of ensur-
ing that your company is on its way to a compliant
quality system is for top level management to
embrace the concept that quality is not just the
inspection department, and a quality system is not
a minimal activity that can be cut short when time
is of the essence or costs are higher than expected.
The quality system defines the work experience
for every person in a company who is involved in
the design, manufacture, distribution and service
of a medical device, for instance. Management
must stress to all levels of the organization that the
quality system is the keystone to the long-term sur-
vival of the operation.
Top management must make a complete com-
mitment in words, actions and support. Support
A quality system’s
requirements always
encourage, and sometimes
mandate, that each
manufacturer continually
compare itself with other
manufacturers.
must be in the form of resources—both personnel
and funding—so all employees understand and
believe that operating to Six Sigma improvement is
the top operating philosophy. By flowing down the
commitment to Six Sigma, management shows that
Six Sigma is a requirement of the operation.
The Six Sigma charter is an important and valuable
document and must clearly define the company’s
position on Six Sigma and provide the direction for
the organization to follow. The Six Sigma charter
should be signed by the top company official and dis-
tributed throughout the organization, as well as the
supplier base and customers.
Benchmarking the Quality System
Benchmarking is the process of evaluating, com-
paring and measuring the products, services and
processes of other organizations. Benchmarking is
a valuable tool in continuous improvement.
Organizations use benchmarking to identify areas
QUALITY PROGRESS I OCTOBER 2007 I 29
SIX SIGMA

that need improvement by showing where others
are doing a better job of meeting customer needs.2
A quality system’s requirements always encour-
age, and sometimes mandate, that each manufac-
turer continually compare itself with other
manufacturers.
If one manufacturer devises a new practice that
lowers the risk of unsafe products reaching con-
sumers, the FDA could promote that practice and
eventually require it as part of cGMP. When an
FDA auditor evaluates a company’s quality sys-
tem, that auditor brings a unique experience based
on other companies and their quality systems.
If any aspect of a system fails to meet the same
level of control that the auditor has seen in other
companies, the system could fail to meet the
requirement of cGMP in the eyes of the auditor. In
other words, with each audit or visit, a company’s
quality system is subjected to an ever-increasing
benchmark and threshold of minimum acceptability.
Through benchmarking, a company must search
out and identify those companies leading the way
in quality system and continuous improvement
fields. From there, a company can develop a quali-
ty system that compares favorably against those
benchmarked systems.
Optical Integrity
Starting from scratch is not an easy task and can
be nearly impossible if a company does not have
FIGURE 1 Cause and Effect Diagram for
Optical Integrity Clean Room Bioburden
Machine Method Material
Product cleaning Pouches
Pouch sealer Packaging Hoops
Room preparation Fibers
Excessive
Ceiling bioburden
Manufacturing
Walls
Test lab Maintenance
Floor
Quality
Air supply
Measurement People Environment
sufficient experience in regulated industries.
Recently at Optical Integrity, a regulatory audit
revealed the company did not have documented
procedures for maintaining and monitoring its
final cleaning and packaging facility for a sterile
medical device.
In response to this finding, the company orga-
nized a team to develop and implement the required
procedures. However, once the procedures were
completed, the owner asked, “Will this pass the
audit?” To answer that question, the team decided to
find out what other companies making similar med-
ical devices were doing. In other words, the team
benchmarked the company’s process.
Compliance Through Design
Design control is another area in which Six Sigma
can play a vital role in the compliance equation.
Organizations often fail when there’s a communica-
tion breakdown in the transition from design and
development to production and operations.3 In prod-
uct design, regulations demand planned reviews and
updates. Each revision must be identified and main-
tained as a record so the sequence of changes can be
tracked. The approval process must be fully defined
in a written, management approved procedure.
Incorporating Six Sigma into the design process
using design for Six Sigma (DFSS), quality function
deployment (QFD), the Pugh concept diagram,
Monte Carlo analysis and robust design will pro-
vide the framework for ensuring every
aspect of the design process is improved
and that customer needs and desires are
incorporated into each new design.4
DFSS is a way of ensuring that the
product design process is optimized and
the resulting design is robust and efficient.
QFD translates the voice of the customer
into design and production requirements
and provides the framework for ensuring
that all customer wants and needs are
evaluated throughout the design and
planning stages to improve customer sat-
isfaction.
QFD also ensures that regulatory
requirements are built into the design
process. Incorporating the tools of contin-
uous improvement into your design

30 I OCTOBER 2007 I www.asq.org

process will enable the company to monitor, mea-
sure and ensure that the design process is handled
in an efficient and effective manner, while provid-
ing a documentation path for each step of the
process.
Training Personnel
Another obstacle of cGMP compliance is increas-
ing the knowledge and understanding of responsi-
ble personnel through training. This might include
industry sponsored seminars, workshops and con-
ferences—which the FDA supports by providing
speakers—as well as in-depth research of require-
ments and other available outside training.
The better the understanding of the regulations,
the better the chances of developing a compliant sys-
tem. With Six Sigma, continuous improvement is not
just for products and processes, but also for all other
aspects of the operation, including knowledge man-
agement and professional development systems.
Optical Integrity has used Six Sigma methods in
job and training analysis to identify both training
and personnel shortfalls to assist in medical device
manufacturing compliance. Others have included
the use of experimental design in the evaluation of
training and instructional programs.5 Another
application is to develop a training requirements
matrix to identify all personnel and their required
training, and then use the matrix to ensure that
each person gets all of the training needed.
The DMAIC Cycle
The FDA is not concerned with the efficiency or
cost of the system or practice to the manufacturer.
The FDA wants to be sure the quality system has
the same level of assurance of safe products as
other manufacturers with good practices. Thus, to
remain compliant with the cGMP requirements of
the FDA, a company must implement within its
own system a continuous, on-going review and
refinement of that system.
Through the DMAIC cycle, Six Sigma provides a
dependable method for a continuous improvement
system.
Define: The define stage is where projects are
identified, the project charter is defined (or rede-
fined) and the project team is established. The
team verifies and validates not only the problem
statement, but also the goals and financial benefits
expected from the project. The team develops the
scope of the project and creates the process map.
Project plans are created in the define stage to pro-
vide team direction in meeting the goals while
staying focused on the specific project objectives.
The better the understanding
of the regulations, the better
the chances of developing a
compliant system.
Six Sigma tools used in this stage include the affin-
ity diagram, tree diagram, process flow chart,
nominal group technique and matrix analysis.
At Optical Integrity, an affinity diagram and
matrix analysis revealed that the facility in use was
inadequate for the operations planned. This finding
resulted in constructing a new facility for the activity.
Measurement: In this stage, the team moves for-
ward and identifies the specific inputs, outputs
and process variables for the project. Data collec-
tion relevant to the goals begins in this stage. The
team develops a plan for what data will be collect-
ed, how the data will be collected and how the
data will be analyzed.
Process capability studies are included in this
stage to determine the ability of the process to
maintain consistent, acceptable production of
product. Tools applicable to this stage include
checksheets, statistical sampling, events logs and
defect maps.
Optical Integrity applied statistical sampling of
the environment and product, along with events
logs, to determine the activities and controls neces-
sary to meet the product specifications for viable
and nonviable particulates. These actions allowed
Optical Integrity to establish and validate required
procedures for the ongoing monitoring of the
process.
QUALITY PROGRESS I OCTOBER 2007 I 31
SIX SIGMA

Analyze: The analyze stage identifies specific refers to the amount of viable microorganisms in or
causes affecting the key variables of the process or on a medical device. During the follow-up audit,
project. This stage identifies the root causes of vari- the auditor determined that the company clearly
ation in processes. Root cause analysis uses many had control of the bioburden on the product and
tools for the detection and understanding of caus- the company complied with regulations.
es, and helps sort those causes that most impact the Improve: The real benefits of the DMAIC cycle
outcome of the process or project. begin to unfold during this stage. Implementation
The tools used in the analyze stage might include of corrective actions and process improvements
cause and effect analysis, Pareto analysis, his- lead to bottom-line advantages, improved customer
tograms, failure modes and effect analysis/failure satisfaction and enhanced regulatory compliance.
modes effects criticality analysis (FMEA/FMECA), In this stage, tool applications might include
trend analysis, design of experiments and gap process redesign, value engineering, design for
analysis. manufacturability and lean manufacturing.
In the clean room at Optical Integrity, product Optical Integrity found that the most significant
and environmental samples submitted to a micro- improvement to the clean room process was realiz-
biology lab provided data for cause and effect ing that entries and exits to the clean room envi-
analysis, as shown in Figure 1. Trend analysis of ronment had the largest impact on the clean room’s
clean room entry and exit activity allowed for com- bioburden.
parison of bioburden results for the product, envi- A change in the frequency of room disinfection
ronment and activities in the room. Bioburden and cleanup—from a time based schedule to an
activity count based sched-
ule—ensured the room would
stay in control when usage
was high. This change also
FIGURE 2 Compliance Requirements Matrix
allowed for reduced disinfect-
Optical Integrity’s compliance requirements matrix provides cross reference of system ing and cleanup during peri-
requirements to procedures. ods of low activity, saving the
company money while ensur-
Section Description Document ID Document topic ing better quality and compli-
4 Quality management system Title only ance.
4.1 General requirements P001 Quality system and policy Control: In this final stage
4.2 Documentation requirements Title only of the DMAIC cycle, the team
4.2.1 General P001 Quality system and policy implements methods to main-
4.2.2 Quality manual P001 Quality system and policy tain the improvements that
P002 Quality system definitions have been accomplished. The
4.2.3 Control of documents P003 Document control team incorporates changes
P004 Change control and improvements into the
P005 Document development operating procedures of the
P006 Quality system numbering organization.
P007 Document distribution and retrieval Additional systems of mea-
4.24 Control of records P042 Quality system records surement might be included
5 Management responsibility Title only to monitor processes or oper-
5.1 Management commitment P001 Quality system and policy ations to ensure compliance
P008 Management responsibility to the newly implemented
5.2 Customer focus P008 Management responsibility changes. Statistical control
P014 Project planning and design input charts and policy deployment
P053 Contract review are some of the tools used in
5.3 Quality policy P001 Quality system and policy this stage.

32 I OCTOBER 2007 I www.asq.org

 Through policy deployment, Optical Integrity
established a monthly review of the laboratory data
with the personnel involved in the lab. Optical
Integrity has been able to maintain the compliance
of the operation to the regulatory requirements, as
well as improve the efficiency of the operation by
maintaining an appropriate environment for the
manufacture of its medical devices.
Building the Quality System
As you develop your quality system, keep in
mind that if you do not include each section of the
regulation, you will need to address or justify those
decisions. One good idea for ensuring that you
have addressed all sections is to develop a compli-
ance requirements matrix. This matrix should
identify each section of your requirements and a
reference to specific paragraphs of your company’s
quality system that clearly covers that section.
Optical Integrity uses a compliance requirements
matrix—shown in Figure 2—as part of its quality
system to ensure that all compliance requirements
are met.
Remember that merely having a compliant qual-
ity system manual is not the end of the line; you
still have to perform to the system. In other words,
do what you say, and say what you do.
Consider the following: If Six Sigma is, as we
believe, a better way to run any operation, then
under the philosophy of cGMP we should expect
the continuous improvement philosophy to be
interpreted as current.
Adopting a Six Sigma philosophy provides a
compliant quality management system and more
importantly, a strategy for continuous improve-
ment. The entire scope of Six Sigma as outlined in
the ASQ Body of Knowledge for Six Sigma Black
Belt Certification—from management commitment
of enterprisewide deployment, to the DMAIC
process, to DFSS and lean manufacturing—pro-
vides a perfect match for meeting both the regula-
tory requirements and international quality
standards.
REFERENCES
1. Dale K. Gordon, “Quality Management Systems vs.
Quality Improvement—What to Tell the CEO,” Quality
Progress, Vol. 35, No. 11, pp. 86-88.
2. Jack B. ReVelle, Quality Essentials from A to Z,
Quality Press, 2004.
3. Jack E. West, “Implementing ISO 9001:2000—Early
Feedback Indicates Six Areas of Challenge,” Quality Progress,
Vol. 34, No. 5, pp. 65-68.
4. Shihab Asfour, Eleftherios Iakovou and Gilbert A. Cortes,
“A Synthesis of Quality Function Deployment and Robust
Design and its Application in the Medical Device Industry,”
Quality Engineering, Vol. 12, No. 1, pp. 37-45.
5. I.L. Goldstein and J.K. Ford, Training in Organizations,
Wadsworth-Thomson Learning, 2002.
ALAN F. CHOW is an instructor at the
Mitchell College of Business at the University
of South Alabama in Mobile. He earned his
master’s degree in quantitative business
analysis at Louisiana State University in
Baton Rouge. Chow is a certified Six Sigma
Black Belt and a senior member of ASQ.
RONALD BOWMAN is director of quality
and regulatory affairs at Optical Integrity
Inc., Panama City, FL. He earned a master’s
degree in business management from Lake
Forest College’s school of management in
Lake Forest, IL.
LEONARD C. WITTENBERG is the program
leadership office Six Sigma lead for Raytheon
Co.’s space and airborne systems business.
He earned a master’s degree in engineering
and production management from Loyola
Marymount University in Los Angeles and
is a certified Six Sigma Black Belt.
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.
QUALITY PROGRESS I OCTOBER 2007 I 33
SARBANES-OXLEY ACT

ASQ Team Says

QMS and EMS
Standards Support
SOX by Sandford Liebesman

In 50 Words
Or Less
• The Securities and Exchange Commission and the
Public Company Accounting Oversight Board asked
for comments on management guidance for internal
controls and Sarbanes-Oxley (SOX) auditing stan-
dards.
• The ASQ SOX Team educated them on how quality
and environmental management systems can sup-
port the design, management and auditing of SOX.
T
he Corporate and Criminal Fraud
Accountability Act of 2002, also known as
the Sarbanes-Oxley Act (SOX), increases
penalties for corporate fraud and imposes greater
oversight on accounting firms.1
SOX was passed in response to the accounting
scandals at Enron, WorldCom, Tyco and other
organizations. SOX’s goal is to protect investors by
improving the accuracy and reliability of corporate
disclosures, including quarterly and annual finan-
cial reports.
The law’s intent was to make the financial system
of control more transparent and to reduce the inci-
dence of corporate fraud. Congress expected the law
to protect the interests of investors through more
appropriate valuation of public company stocks.
The act established the Public Company

34 I OCTOBER 2007 I www.asq.org

Accounting Oversight Board (PCAOB) as a sub-
sidiary of the Securities and Exchange Commission
to oversee the auditing and preparation of audit
reports by public companies. In 2003, SEC adopted
rules requiring stock issuer’s annual reports to
include an assessment of the company’s internal
control over financial reporting (ICFR) in addition
to an auditor’s report on that assessment.
PCAOB’s New Auditing Standard
In 2004, the PCAOB created Auditing Standard
No. 2 (AS No. 2) to apply to the newly required
external audits.2
It soon became evident that compliance to the
auditing requirements of the act was very costly,
especially for smaller firms. PCAOB and the SEC
gathered information from public auditing firms,
held two roundtables and received feedback on
auditing small businesses.
This information highlighted significant benefits
from the focus on corporate governance, but at a
significant cost. There was concern that AS No. 2
encouraged auditors to perform procedures not
necessary to satisfy the intent of the act.
In response, the PCAOB proposed a new stan-
dard,3 and the SEC proposed a guidance document
for management to use in complying with SOX.4
The PCAOB and SEC asked for public comments
by Feb. 26, 2007.
Ron Atkinson, ASQ president at the time, and
the ASQ SOX Team each submitted comments on
the proposed documents.5 After receiving the pub-
lic comments, the PCAOB published the final ver-
sion of the standard on May 24,6 and the SEC
QUALITY PROGRESS I OCTOBER 2007 I 35
SARBANES-OXLEY ACT
published the final version of the guidance docu-
ment on June 20.7
The PCAOB proposal is designed primarily to
accomplish the following:
• Focus the audit on a risk based, top-down
approach. The auditor should direct testing to
the most important controls and emphasize
the importance of risk assessment.
• Eliminate unnecessary procedures, such as the
requirement to evaluate management’s report-
ing process.
• Allow a reduced number of walkthroughs
during audits. Walkthroughs are procedures
to evaluate the flow of transactions.
• Permit consideration of knowledge obtained
during previous audits and remove barriers to
using the work of others.
• Scale the audit for smaller and less complex
companies.
• Simplify the requirements by reducing detail
and specificity, which should result in better
readability and an improved sequential flow
of the audit.
• Align the key terms and concepts with those
found in the SEC guidance document.
• Discuss fraud risk and antifraud controls at the
beginning of the standard to emphasize the
importance of these matters in assessing risk.
• Explain the effect entity level controls have on
selecting and testing other specific controls.
Entity level controls test functions at the top
of the organization.
SEC’s Interpretive Guidance
The SEC’s interpretive guidance for manage-
ment to use in its evaluation of ICFR as required
by section 404 of SOX focuses on conducting a top-
down, risk based evaluation and is intended to
help companies of all sizes complete their annual
evaluations effectively and efficiently. An evalua-
tion that complies with the guidance is one way to
satisfy the SEC requirements.
The SEC set two broad principles for conducting
the evaluation:
1. Management should evaluate whether it has
implemented controls that adequately address
the risk that a material misstatement of the
financial statements would not be prevented
or detected in a timely manner.
36 I OCTOBER 2007 I www.asq.org
2. Management’s evaluation of evidence about
the operation of its controls should be based
on its assessment of risk.
In addition, the guidance relies on general prin-
ciples rather than being prescriptive. This allows
an organization to tailor its responses to their struc-
ture and circumstances.
The 2003 SEC rules implementing SOX Section
404 required management to use a framework for
evaluating ICFR. The rules do not mandate a spe-
cific framework, but they do identify the “Internal
Control—Integrated Framework” created by the
Committee of Sponsoring Organizations of the
Treadway Commission (COSO) as an example.8
As SOX was implemented, many management
teams used the prescriptive AS No. 2 auditing
standard instead of COSO. This resulted in dupli-
cation and high implementation costs. The SEC
guidance is expected to bring organizations back
to using COSO.
Comments on AS No. 5
And the Interpretive Guidance
In 2003, four members of ASQ9 recognized the
opportunities for quality management systems
(QMSs) and environmental management systems
(EMSs) to support the financial managing organi-
zations in satisfying SOX. They formed the ASQ
SOX Team, and the SOX Community was created
later as the first ASQ community of interest.
The SOX team comments are intended to identify
parts of the two documents that can be supported
by specific quality and environmental management
principles, tools and techniques. The team used the
ISO 9001 and ISO 14001 standards to illustrate its
comments.
The use of monitoring, measurement and data
analysis to identify and correct potential risks: AS
No. 5 requires company level controls that include
controls to monitor the results of operations.
Clauses 8.2.3 and 8.2.4 of ISO 9001 and 4.5.1 of ISO
14001 require monitoring and measurement of
products and processes on a regular basis.
ISO 9001, clause 8.4, requires analysis of data
generated by clauses 8.2.3 and 8.2.4 as well as cus-
tomer satisfaction and supplier data. This analysis
can provide information to auditors on the early
identification of risks by the organization.
Maintenance of records: AS No. 5 requires the
company’s ICFR to include policies and proce-
dures pertaining to records that accurately and
fairly reflect the assets of the company and provide
reasonable assurance that transactions are recorded
to permit ICFR.
ISO 9001, clause 4.2.4, requires that records be
legible, readily identifiable and retrievable, and
that a documented procedure be established to
define controls needed for identification, storage,
protection, retrieval, retention time and disposition
of records. These controlled records can be used by
external auditors.
Personnel competence: AS No. 5 discusses com-
petence in several places. For example, it says,
“The impact of the work of others on the auditor’s
work also depends on the relationship between the
risk and the competence and objectivity of those
who performed the work.”
It also says, “The auditor should test the operat-
ing effectiveness of a specified control by determin-
ing whether the specified control operated as
designed and whether the person performing the
control possesses the necessary authority and qual-
ifications to perform the control effectively.”
ISO 9001, clause 6.2.2, and ISO 14001, clause
4.4.2, require determination of competence, provi-
sion of training and evaluation of the effectiveness
of the training.
With respect to qualifications of internal quality
and environmental auditors, RABQSA and ASQ
provide certification of these auditors, so their
work can be used by SOX auditors.
Clarification of management’s roles and
responsibilities: AS No. 5 requires the auditor to
assess whether management’s philosophy and
operating style promote effective ICFR.
ISO 9001, clause 5.1 on management commit-
ment, requires top management to provide evidence
of its commitment to the development, implementa-
tion and continual improvement of the QMS.
AS No. 5 also says the auditor should test the
design effectiveness of controls by ensuring that
they are operated by persons with the necessary
authority and competence and can prevent or
detect errors or fraud.
ISO 9001, clause 5.5.1, and ISO 14001, clause
4.4.1, require top management to define responsi-
bilities and authorities, and communicate them
within the organization.
Using the work of others: AS No. 5 says that for
auditing of internal control, the auditor can use the
work performed by, or receive direct assistance from,
internal auditors, company personnel (in addition to
internal auditors), and third parties working under
the direction of management or the audit committee.
AS No. 5 also says the auditor should under-
stand the flow of transactions related to the rele-
vant assertions, including how these transactions
With respect to qualifications
of internal quality and envi-
ronmental auditors, RABQSA
and ASQ provide certification
of these auditors, so their
work can be used by SOX
auditors.
are initiated, authorized, processed and recorded.
The auditor can perform walkthroughs to test
design effectiveness. A walkthrough consists of a
mix of inquiry of appropriate personnel, observa-
tion of the company’s operations, inspection of rel-
evant documentation and retesting of controls.
It is clear from these comments that robust
QMSs and EMSs can provide valuable support for
compliance to AS No. 5, particularly because of the
standard’s numerous references to using the work
of others.
Team Comments on the
New SEC Guidance
The SOX team also commented on the various
areas of support QMSs and EMSs can provide top
management in ensuring the effectiveness of a sys-
tem of internal control, as covered by the SEC’s
guidance for reporting ICFR.
Preventive and corrective action: The guidance
says management can identify preventive controls,
detective controls or a combination of both, as
adequately addressing financial reporting risks.
QUALITY PROGRESS I OCTOBER 2007 I 37
SARBANES-OXLEY ACT
Preventive controls stop the occurrence of errors
or fraud that could result in a misstatement of the
financial statements, while corrective controls
detect and correct errors or fraud that have
already occurred.
ISO 9001, clauses 8.5.2 and 8.5.3, and ISO 14001,
clause 4.5.3, provide best practices and require doc-
umented procedures for dealing with actual and
potential risks, and also for taking corrective or
preventive actions.
The use of monitoring, measurement and data
analysis to identify and correct potential risks:
Organizations effectively
using the SEC guidance
should be able to satisfy the
requirements of the PCAOB
standard and pass the audit
performed by their external
auditor.
The guidance says monitoring activities must
assess the quality of internal control performance
over time.
ISO 9001, clauses 8.2.3 and 8.2.4, require moni-
toring and measurement of products and process-
es, and clause 8.4 requires analysis of data obtained
as a result of these clauses, as well as customer sat-
isfaction and supplier data. The results of the
analysis identify risks to the organization’s objec-
tives and provide inputs to the corrective and pre-
ventive action processes.
ISO 14001, clause 4.5.1, requires monitoring and
measurement of operations, and clause 4.5.2 requires
evaluation of compliance to legal requirements.
Controls to manage the organization’s docu-
ments and records: The guidance says manage-
ment’s assessment must be supported by evidence
that provides reasonable support for its assessment.
The nature of the evidential matter might vary
38 I OCTOBER 2007 I www.asq.org
based on the assessed level of ICFR risk of the
underlying controls.
ISO 9001, clause 4.2, on documentation require-
ments, provides a method for controlling the doc-
umentation and records associated with the
procedures of the organization.
Clarification of management’s roles and respon-
sibilities: The guidance says management is respon-
sible for designing and maintaining ICFR and
performing an annual evaluation that provides a rea-
sonable basis for its assessment of whether ICFR is
effective as of fiscal year-end. Management uses its
knowledge of the business, its operations and
processes as part of the evaluation.
ISO 9001 aligns operational compliance with
financial evaluations in clauses 5.6 on management
review, 8.2.2 on internal audit and 8.4 on analysis
of data. ISO 14001 does this in clauses 4.6 on man-
agement review, 4.5.5 on internal audit and 4.5.2 on
evaluation of compliance.
Using the work of others: The guidance notes
that both the COSO framework and the Turnbull
report10 say that determining whether a system of
internal control is effective is a subjective judgment
resulting from an assessment of whether the five
components (control environment, risk assessment,
control activities, monitoring, and information and
communication) are present and functioning effec-
tively.
The quality and environmental management
systems provide support for the five COSO compo-
nents through compliance to ISO 9001 and ISO
14001. This support is described in detail in my QP
September 2005 article, “Mitigate SOX Risk With
ISO 9001 and 14001.”11
Why Two Documents?
The effort by the SEC and PCAOB to refocus
SOX to a risk based, top-down approach will result
in organizations concentrating on the key controls
that can indicate the possibility of material mis-
statements in financial statements.
This focus will reduce the cost of compliance,
allow organizations to emphasize their important
business processes and foster the use of quality
improvement tools. The result will be more effec-
tive operations.
The reason there are two documents covering
the same basic process is that they deal with two
different aspects of the SOX compliance effort:
1. The PCAOB standard is aimed at the external
auditing process. This compliance based docu-
ment provides prescriptive requirements for the
auditor and the organizations being audited.
2. The principles based SEC document is non-
prescriptive and defines a method for ensur-
ing that management’s system of internal
control is operating effectively and is accept-
able to the SEC.
Of course, there are many similarities in the two
documents, and organizations effectively using the
SEC guidance should be able to satisfy the require-
ments of the PCAOB standard and pass the audit
performed by their external auditor.
The SOX team found opportunities in the two
documents for building quality into the SOX com-
pliance process. This includes the following key
practices of the quality and environmental commu-
nities:
• Preventive and corrective action techniques.
• The use of monitoring, measurement and data
analysis to identify and correct potential risks.
• Methodology for ensuring personnel compe-
tence.
• Controls to manage an organization’s docu-
mentation and records.
• Clarification of management’s roles and
responsibilities.
• The use of the work of QMS and EMS person-
nel in a SOX audit.
The bottom line is that QMSs and EMSs and the
involved personnel can support financial manage-
ment in compliance to SOX. This was made clear in
the SOX team’s full set of comments to the SEC
and PCAOB.
REFERENCES AND NOTES
1. The Corporate and Criminal Fraud Accountability Act
of 2002, also known as the Sarbanes-Oxley Act (Public Law
107-204), U.S. Congress, 2002; see the frequently asked ques-
tions at www.asq.org/communities/sarbanes-oxley/
faq.html for a link to a copy of the law.
2. Auditing Standard No. 2, An Audit of Internal Control Over
Financial Reporting Performed in Conjunction With an Audit of
Financial Statements (AS No. 2), PCAOB, 2004.
3. Public Company Accounting Oversight Board, PCAOB
Release No. 2006-007, PCAOB Rulemaking Docket Matter
No. 021, Proposed Auditing Standard—An Audit of Internal
Control Over Financial Reporting That Is Integrated With an
Audit of Financial Statements and Related Other Proposals, 2006,
www.asq.org/communities/sarbanes-oxley/abstracts/
team-comments.html
4. Securities and Exchange Commission, File No. S7-24-06,
Management’s Report on Internal Control Over Financial
Reporting, 2006, www.asq.org/communities/sarbanes-oxley/
abstracts/team-comments.html
5. Letters dated Feb. 23, 2007, www.asq.org/communities/
sarbanes-oxley/abstracts/team-comments.html.
6. Public Company Accounting Oversight Board, PCAOB
Release No. 2007-005, An Audit of Internal Control Over
Financial Reporting That Is Integrated With an Audit of Finan-
cial Statements and Related Independence Rule and Conforming
Amendments, 2007.
7. Securities and Exchange Commission, 17 CFR Part 241,
Commission Guide Regarding Management’s Report on Internal
Control Over Financial Reporting, 2007.
8. COSO, “Internal Control—Integrated Framework,”
1992. This is commonly called the COSO guidance.
9. The four team members were Sandford Liebesman,
Paul Palmes, John Walz and Donna Spencer. Marty Jaeger
and Chad Kymal joined the team later.
10. Internal Control, Guidance for Directors on the Combined
Code, Institute of Chartered Accountants in England and
Wales, 1999.
11. Sandford Liebesman, “Mitigate SOX Risk With ISO
9001 and 14001,” Quality Progress, September 2005, pp. 91-93.
SANDFORD LIEBESMAN had more than 30 years of experi-
ence in quality at Bell Laboratories, Lucent Technologies
and Bellcore (Telcordia) before becoming a consultant. He is
an ISO 9000 subject matter expert and author of the books
TL 9000, Release 3.0: A Guide to Measuring Excellence
in Telecommunications, second edition, and Using ISO
9000 to Improve Business Processes. He is a member of
ISO technical committee 176 and the ANSI Z-1 committee
on quality assurance. Liebesman is certified by the
RABQSA International as an ISO 9000 and TL 9000 lead
auditor. He is an ASQ fellow.
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.
QUALITY PROGRESS I OCTOBER 2007 I 39
CASE STUDY
Agency Files Away
Inefficiency, Saves
Taxpayers a Bundle
by Susan E. Daniels, editor at large
O
ne of the three silver medal winners in
the 2007 International Team Excellence
Competition created a solution that has
the potential to save Florida taxpayers more than
$18 million over time.
The competition is sponsored by ASQ’s Team
and Workplace Excellence Forum, and team pre-
In 50 Words
Or Less
• A social service agency’s document storage system
required nearly 11,000 square feet of leased space and
cost more than $300,000 a year to maintain.
• A team’s effort exceeded expectations and could save
Florida taxpayers more than $18 million.
• The solution has been benchmarked extensively.
40 I OCTOBER 2007 I www.asq.org
sentations are judged annually at ASQ’s World
Conference on Quality and Improvement.
Caseworkers for the SunCoast Region of the
Florida Department of Children and Families gen-
erate more than 1.5 million paper documents annu-
ally. The region’s goal was to redesign its paper
based document filing and retrieval system and
bring it into the digital age.
Tools the region was already using to achieve its
mission and vision were:
• Florida’s Sterling Award management model,
which is based on the Malcolm Baldrige
National Quality Award criteria for perfor-
mance excellence.
• Self-directed teams.
• A cascading performance management and
review approach.
• Automated data dashboards to track and
monitor performance levels and trends daily.
• The plan-do-check-act cycle to conduct evalu-
ation and improvement efforts.
• Listening and learning mechanisms, such as a
complaint management process, client sur-
veys, brainstorming, and cause and effect
analysis, to identify, prioritize and align
improvement initiatives.
Identifying the Problem
One team, Team Redesign, used process analysis
data to identify the document filing and retrieval
system as a potential target for savings and effi-
ciencies. The existing system was paper driven,
costing more than $300,000 a year to maintain,
including the cost of leasing nearly 11,000 square
feet of space to house these documents.
The process of identifying and validating stake-
holders and requirements showed customer com-
plaint data that described delays directly related to
the paper process and reported increased frustra-
tions of internal and external customers.
This led to the creation of Team ScanIt, a sub-
team of the larger Team Redesign. It was clear that
Team ScanIt’s efforts would directly impact organi-
zational goals: dramatically improve service to cus-
tomers, improve performance by consistent data
driven management and continue modernization
and reform.
The team’s work would also affect several orga-
nizational goals and performance measures, in-
cluding timeliness, accuracy, number of office
visits, cycle time, cost and efficiency.
The team’s members (see photo on p. 43) repre-
sented a cross section of staff from operations, pro-
grams, quality management and administration.
Team ScanIt started by reviewing each step of the
document storage and retrieval process to ensure
the validity of stakeholder impact. It looked at the
data related to the number of days it took to process
documents. The team soon realized that eliminating
the time spent looking for cases and moving paper
through the process would impact stakeholders by
allowing them instant access to information.
For example, clerical staff—the key internal
stakeholders—would replace a cumbersome pro-
cess with electronic filing and retrieval. The new
process would redefine their job duties and im-
prove their work environment.
Among external stakeholders, the region’s cus-
tomers would be affected the most. They would no
longer have to return information to the agency
more than once and would receive their benefits
more quickly.
Electronic Solution
After completing an efficiency matrix comparing
the current system with available electronic filing
systems, it was obvious to the team that an elec-
Stakeholders were involved
in each step of the process,
and concerns were eliminated
as they had a firsthand view
of the system’s capabilities
and potential.
tronic filing system was the way to go. Now the
question became, what type of electronic system?
To answer that question, the team first did some
benchmarking, reviewed and tested vendors of
off-the-shelf systems and researched other possi-
bilities online. Data flow diagrams verified that an
electronic system would result in savings and im-
proved services.
The team posted a request for vendor proposals
for off-the-shelf systems. Using the project require-
ments criteria, the team evaluated each proposal
and compared it with an internally developed
solution. The requirements matrix led the team to
choose the vendor route—a decision that ultimate-
ly would be abandoned when that method didn’t
meet needs.
While the vendor solution wasn’t a success, it did
validate the team’s plan for an electronic system.
Not only would the system eliminate all paper case
files, allow instant access, reduce cycle time and
save money, it would also provide intangible bene-
fits, such as the ability to shift workload rather than
staff and manage mandated staff reductions.
Stakeholder groups, including the 15 (now nine)
service centers, IT, program office and quality
assurance (QA) staff were involved in selecting
and developing the in-house solution.
The team used various methods to validate the
prototype: user feedback, comparisons with indus-
try standards and predesigned audit processes,
including manual and electronic log audits and IT
system tools. QA staff did daily audits to ensure
compliance with required functionality, accuracy
and efficiency.
Because of the demand for speed, an equipment
vendor designed a high-speed scanner, the first of
its type in the United States, for the SunCoast
QUALITY PROGRESS I OCTOBER 2007 I 41
CASE STUDY

FIGURE 1 Salary Savings

Region to use. Testing verified that the new system
600 reduced scanning cycle time by nearly 44%.
All position salary reduction
500 Good (12.2% reduction)
$4,095,517 Phased Implementation
400 After analyzing the results of beta testing, file
Clerical position salary reductions
300 preparation, scanning of existing documents and
(41% reduction)
$1,349,937 process improvement focus sessions, the team
200
developed an implementation action plan.
100 41%
Stakeholders expressed concerns that there
would be manpower shortages for converting files,
0
Specialist I Specialist II Supervisor Inter- Clerical difficulties in locating and retrieving case informa-
viewing tion and lack of equipment. So, the team developed
clerk
Prior to redesign implementation a resistance mitigation plan. This plan included
Redesign initial staff reductions hiring temporary staff to assist with scanning pre-
Staff reductions after technology enhancements vious case files.
To reduce potential resistance and promote buy-
in, the team also held predeployment meetings,
training and feedback forums. Stakeholders were
FIGURE 2 Cases Per Worker
involved in each step of the process, and concerns
And Cycle Time Reductions
were eliminated as stakeholders had a firsthand
Project
scanning project
redesign

20 1200 view of the system’s capabilities and potential.

types

1100
assistance

18 Process flowcharts, procedural guides and training

Regionrign

960
Implementation of Scanning
to complete applications
Average number of days

1000
16 15 manuals ensured deployment consistency.
numberofofbenefit
worker
Start of SunCoast region

14
14 13 13 13 800 Solution implementation was completed in
12 12
worker

12 11
711 stages:
per per

10 600
Averagenumber

8 • Phase one saw all service sites begin file

groups

542
6 400 preparation, including manual preparation of
Average

4 200 paper files for scanning, boxing and transport-

2 ing to off-site storage until the quality and
0 0
2003
Note: Benefit types include food stamps, temporary assistance
and Medicaid coverage.
FIGURE 3
Leased space reductions
Equipment lease reductions
Annual storage costs for newly closed cases
Annual case record creation costs
Savings for fiscal year ’05/’06
Initial investment on non-leased equipment
Fiscal year ’05/’06 savings
Fiscal year ’06/’07 savings
Savings and cost avoidance
2004 2005 April
reliability of the new system was ensured. At
2006 the same time, pilot sites began scanning
State
active files.
SunCoast Region
• Phase two focused on incoming documents
Benefit type worker
rather than active files. Work included live scan-
ning and system modifications based on stake-
holder feedback. During this time, the time to
view images decreased from 24 hours to one.
The team was now ready to roll out the long-
Enterprise Savings
term, in-house solution. One service center at a
time was converted to the new database. This
$171,131 process included testing each computer, scanner
$34,000 and service for accuracy and speed. QA checks
$12,299
ensured image quality, data integrity and system
$91,021
capability. Staff members were trained on enhance-
$308,451
ments such as automated workload distribution.
($77,708)
The team incorporated monitoring tools and
$230,743
$308,451
reports for the new system into the existing perfor-
mance management system. QA reviews measure
$539,194
the quality and integrity of the new system related

42 I OCTOBER 2007 I www.asq.org

TEAM SCANIT: Members of Team ScanIt included (from left) Denise Hicks, operations program administrator for
initial planning, system development and deployment; Lourdes Benedict, operations manager, team leader and
presentation team leader; John Palumbo, operations program administrator, quality assurance representative
and team facilitator for presentations; Vivian Padron, operations management consultant manager; and Dianna
Laffey, operations management consultant, information liaison, beta testing coordinator, technical support and
roll-out coordinator. Not pictured are Gary Stephan, web development manager, and Martin Smalley, regional
manager for IT, the two main programmers for the filing and retrieval system the team developed.

to end user activities and equipment.
To identify process issues and best practices and
evaluate adherence to the new process, the team
created a comprehensive monitoring tool. Analysis
of this data is part of the continuous improvement
cycle and is used to determine the most efficient
type and placement of equipment that will be pro-
cured in the future.
Reported Results
The system allowed the region to manage man-
dated staff reductions in spite of an increase in
workload. As shown in Figure 1, there was a more
than $4 million salary savings in the first year after
implementation, of which about $1.3 million was
due to a 41% reduction in clerical staff responsible
for file maintenance.
The region increased the number of cases per
worker by 54% while maintaining application time
standards, a key organizational measure (see Figure 2).
The annual tangible savings was nearly $540,000,
as shown in Figure 3 (p. 42). Annual paper system
costs were reduced by more than $308,000, includ-
ing about $91,000 associated with the production
of paper files. Files, which previously took a mini-
mum of 24 hours to retrieve, are now available

QUALITY PROGRESS I OCTOBER 2007 I 43

CASE STUDY

within three to five seconds. reduced copier costs.

By designing the software system in-house, the
region avoided spending an extra $300,000 or $1
million, depending on the vendor, in costs for sys-
tem development and license fees.
Finally, the region’s solution was adopted
throughout Florida, resulting in electronic storage
of nearly 1.5 million files. Documents are now
shredded on-site 90 days after they are created.
Several results exceeded expectations:
• Images are more legible than paper copies.
• Postage and courier costs for moving files
between locations, and travel expenses for
monitoring were eliminated.
• Workload distribution is automated.
• Audit trails track when an image is viewed
and by whom.
• Standardizing the hardware platform has
• There is no longer a threat of files being
destroyed by fire or natural disasters.
• Case processors can telecommute.
Team ScanIt’s effort had the desired impact on key
organizational goals and performance objectives.
The innovation in Florida’s SunCoast Region has
been recognized nationally. The U.S. Department
of Agriculture’s Food and Nutrition Service recog-
nized it as an innovative solution, and officials
from more than 40 states participated in work-
shops to benchmark the effort.
EDITOR’S NOTE
Look for case studies showcasing the accomplishments of
the other four winning teams from the 2007 International
Team Excellence Competition in future issues of Quality
Progress.

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44 I OCTOBER 2007 I www.asq.org

QUALITY FUNCTION DEPLOYMENT
DFX and DFSS:
How QFD
Integrates Them
by Jui-Chin Jiang, Ming-Li Shiu and Mao-Hsiung Tu
D
esign for excellence (DFX) and design for
Six Sigma (DFSS) have been two of the
most popular concepts in quality man-
agement in recent years, but very little has been
written comparing DFX and DFSS. This article
aims to clarify the differences between them in
concept and application and further identify how
In 50 Words
Or Less
• Quality function deployment provides an
architecture that can effectively position
and combine design for excellence and
design for Six Sigma.
• By combining these methods, manufactur-
ers can differentiate a product in terms of
quality prior to the actual production
process.
to integrate them effectively by using quality func-
tion deployment (QFD).
It is a good starting point to understand the
roots of the words “excellence,” “Six Sigma” and
“quality.” Aristotle might have been the first per-
son to talk on the subject of quality in any system-
atic way.1 In his book Metaphysics, he gave four
definitions of quality and later summarized them
with two basic meanings: “differences of real sub-
stance” and “mode of a subject in motion, of itself.”
Good (excellence) and bad (inferiority) are parts of
the latter mode.
Simply speaking, there are two aspects of quali-
ty, according to Aristotle: different quality and
good quality. Discussions of quality have revolved
around these two aspects since Aristotle’s time.2
Whether you’re creating different quality or try-
ing to achieve good quality, you must build quality
into a product when it is planned and designed.
Quality built in at this stage has the maximum
return in terms of cost benefits and customer satis-
faction. It far surpasses the improvements brought
about by relying separately on promotional efforts
in selling or detection and modification in manu-
facturing after a product is released. DFX and
DFSS both help build quality into the design stage.
QUALITY PROGRESS I OCTOBER 2007 I 45
 QUALITY FUNCTION DEPLOYMENT
Design for Excellence
DFX has evolved and is still evolving from
design for manufacturability. By manufacturability,
we mean the ease with which a product or compo-
nent can be produced. Historically, designers have
overlooked manufacturability and have concen-
trated their efforts on function, features and
appearance of their products. However, concentrat-
ing on manufacturability during product design
has great cost benefits.3
Today, a limited series of design objectives—
function, features and appearance—even when
manufacturability is added, is not enough to pro-
vide the most competitive, economical and benefi-
cial design to customers and society over the long
run.4
DFX is intended to provide designers with an
objective deployment framework and a means to
achieve all desirable dimensions of quality. DFX
can be viewed as a design approach that deals with
Aristotle’s different quality while focusing on the
right thing to design.
When we look at research in this field, two
renowned examples are the eight quality dimen-
sions David Garvin proposed5 and the internal
structure of quality Noriaki Kano proposed.6 Based
on these ideas, we propose nine dimensions of
quality, or DFX objectives:
1. Higher functional performance: Higher effect
levels of a product’s main operating character-
istics.
2. Physical performance: Dimension, volume
and weight of a product.
3. User friendliness: How easily a product is
used.
4. Reliability and durability: Reliability refers to
how free of failure a product is during a peri-
od of time. Durability refers to a product’s
lifespan.
5. Maintainability and serviceability: How easy
it is to restore a product’s usability after a fail-
ure.
6. Safety: How free of injury and hazard the pro-
duct’s user is.
7. Compatibility and upgradeability: Compati-
bility refers to the ease of combining a product
with another product. Upgradeability refers to
the ease of incorporating improved or addi-
tional features into a product.
46 I OCTOBER 2007 I www.asq.org
8. Environmental friendliness: The product’s
manufacturing process, use and disposal are
free of environmental pollution and hazards.
9. Psychological characteristics: Product aesthet-
ics as perceived by the user’s five senses and
the sensibility that relates to the user’s think-
ing, feeling and discerning about a product.
It should be pointed out that DFX objectives are
all the desirable factors a product should theoreti-
cally have. In practice, DFX objectives are met by a
company’s selective quality characteristics.
Design for Six Sigma
Six Sigma is a disciplined and highly quantita-
tive approach to improving product or process
quality. The goal is to reduce defects to no more
than 3.4 per million opportunities. Six Sigma was
introduced at Motorola and has been adopted and
generalized by numerous companies, such as
Allied Signal and General Electric.
Companies that have adopted Six Sigma have
realized that once they have hit a “five sigma wall”
and progress has come to a standstill, the only way
to surpass this wall is to apply DFSS. DFSS is a rigor-
ous approach to designing products from the begin-
ning to ensure customer requirements are met.7
DFSS can be viewed as a design approach that
deals with Aristotle’s good quality and a focus on
how to design the right thing right. DFSS follows
the define, measure, analyze, design and verify
(DMADV) phases during design projects. The core
concept of DMADV implementation is to gradual-
ly flow down new products’ critical-to-quality
characteristics to functional design, detailed design
and process control variables, and then flow up
capability to meet these requirements.8
Quality Function Deployment
QFD is a method of new product development
under the umbrella of total quality management. It
is a process for systematically converting cus-
tomers’ demands into design quality, and it
deploys quality over design targets and major
quality assurance (QA) points, or milestones, used
throughout the product development process.
QFD was conceived in Japan in the late 1960s
while Japanese industries were departing from
their postwar mode of product development,
which had essentially involved imitation and copy-
 FIGURE 1 Comprehensive Quality Function Deployment System
Finished product
quality characteristics

Market evaluation
Demanded quality
items • Competitive analysis
3
• Complaints/claims
2
3 • Planned quality
1
3 • Selling points
1. Primary 2

2. Secondary 3
• Kano’s attractive
quality survey
3. Tertiary • Competitive analysis
• Design target setting
Setting
• Specification tolerance design
target
• Key quality characteristic list
• Bottleneck engineering list

Cost deployment
Parts

• Component unit specifications

• Bottleneck engineering list
• FTA/FMEA
Subsystems • Key component/part list
• Supplier feasibility and capability survey

• Production specifications
• Bottleneck engineering list
• FTA/FMEA
Processes
• Key control item list
• Quality assurance process sheet
• Shopfloor management system design

FTA = fault tree analysis

FMEA = failure mode effects analysis

ing, and were moving toward original product
development. At that time, there was recognition
of the importance of designing quality into new
products, but there was a lack of guidance on how
to achieve it.
Companies were already inspecting for quality,
but it was happening at the manufacturing site
after new products had been produced.9
Yoji Akao first presented the QFD concept and
method to solve these problems, and QFD has con-
tinued to spread since Shigeru Mizuno and Akao
published their first book on the topic in 1978.10
To ensure smooth product development, Akao
constructed a comprehensive QFD system that
considers quality, technology, cost and reliability
simultaneously.11 The objective of each deployment
is as follows:
• Quality deployment is to systematically de-
ploy customers’ demanded quality over the
design targets and major QA milestones used
throughout the product development process.
• Technology deployment is to extract any bot-
tleneck engineering (BNE) that hinders quality
and solve it at the earliest possible time.
• Cost deployment is to achieve the target cost
while keeping a balance with quality.
• Reliability deployment is to prevent failures
and their effects through early prediction.
Figure 1 shows the concept in an integrated way.
The first step for QFD implementation is to

QUALITY PROGRESS I OCTOBER 2007 I 47

QUALITY FUNCTION DEPLOYMENT
decide on a target market and formulate a product
portfolio strategy. Then, a survey is conducted
with the market’s customers, and a demanded-
quality deployment chart is made.
According to market evaluation information
such as competitive analysis and claims analysis,
the company might conduct quality planning and
determine the new product’s individuality or sell-
ing points. Kano’s attractive quality survey helps
to conduct product planning for creating attractive
quality.12
Customers express demanded qualities by
Like product design, process
design must effectively prevent
a recurrence of the existing
process’s design problems and
the potential design problems
of the new process.
directly describing and perceiving what product
quality is. However, demanded qualities must be
converted to quality characteristics—that is, the
technical language a company’s R&D personnel
use to understand how to technically achieve the
demanded qualities. Only in this way is it possible
to materialize them through development technol-
ogy.
Therefore, it is necessary to carry out a quality
characteristics deployment of the finished product
to transform product quality from the world of the
customer into the world of technology. The compa-
ny can choose design specification values accord-
ing to competitive analysis and extract the BNE,
which hinders the realization of the design quality.
When a product is designed and developed,
rather than directly designing the entire product,
48 I OCTOBER 2007 I www.asq.org
R&D personnel view the subsystem or component
unit (also known as a building block) of the inter-
mediate layer of the product architecture as the
design unit. As a result, a subsystem’s deployment
is necessary to allocate the specification tolerance
of the finished product’s quality characteristics to
relevant component units.
In the design stage, the product must effectively
prevent a recurrence of the existing product’s design
problems as well as the new product’s potential
design problems. To that end, a fault tree analysis
(FTA) and failure mode effects analysis (FMEA) can
be employed. With respect to parts and materials
needed for constructing subsystems, deployment is
required, and an evaluation of the supplier’s feasi-
bility and capability should be conducted.
Products are made through processes and com-
pleted by assembling semifinished products.
Therefore, a semifinished product and its specifica-
tions defined by the subsystem’s deployment are
made using process deployment and design and
by deciding specifications of process conditions
(also known as production specifications).
Like product design, process design must effec-
tively prevent a recurrence of the existing process’s
design problems and the potential design problems
of the new process. This can be done by drawing
on equipment FTA and process FMEA.
Based on process deployment and FMEA infor-
mation, a QA process sheet (also known as control
plan) can be created to provide an overview of
information needed for process control. The design
of the shop floor management system needed to
execute the QA process sheet, which is part of the
process design, ensures that before a product
enters mass production, adequate preparations are
already in place to achieve manufacturing QA.
The foregoing quality deployment, which
includes technology and reliability, can realize cus-
tomers’ demanded qualities and failure free quali-
ties, yet it might increase the cost as a result. By
using market evaluation information to decide the
target cost of the finished product, and by corre-
sponding to quality deployment flows to set up
cost targets for materials and labor, a balance
between QA and cost reduction can be achieved.
Integrating DFX and DFSS
QFD’s structural integrity when dealing with
 FIGURE 2 QFD Toward DFX and DFSS Positioning and Integration

All desirable dimensions of quality

Finished product
quality characteristics

Market evaluation
DFX
Demanded quality Product target cost identification
items • Competitive analysis • Value proposition
3
• Complaints/claims development/positioning
2
3 • Planned quality • Design characterization
1
1. Primary 2
3
• Selling points and differentiation
2. Secondary 3 • Kano’s attractive
quality survey
3. Tertiary • Competitive analysis
• Design target setting
Setting
• Specification tolerance design
target
• Key quality characteristic list
• Bottleneck engineering list

Cost deployment
Parts DFSS
• Optimal (Six Sigma) product
• Component unit specifications specifications development
• Bottleneck engineering list and tolerance allocation
• FTA/FMEA • Product specifications
Subsystems • Key component/part list design verification
• Supplier feasibility and capability survey • Optimal process conditions
design and verification
• Shopfloor management system
design and verification

• Production specifications
• Bottleneck engineering list
• FTA/FMEA
Processes
• Key control item list
• Quality assurance process sheet
• Shopfloor management system design

DFX = design for excellence

FTA = fault tree analysis
FMEA = failure mode effects analysis

critical issues (quality, technology, cost and reliabil-
ity) of new product development helps position
and integrate DFX and DFSS, as illustrated in
Figure 2.
DFX is a design method that deals with
Aristotle’s different quality. It can integrate with
QFD in converting demanded qualities into quality
characteristics. In other words, it ensures that:
• In planning all desirable dimensions of
demanded quality, a value proposition is
developed based on the selection of quality
niches (one X or several Xs).
• In the design stage of demanded quality char-
acterization, the design targets that can sup-
port the value proposition are set.
• Product design for the DFX and its verifica-
tion can then be conducted downstream.
DFSS can integrate with QFD in tolerance design
and process design of a product. That is, after set-
ting the design targets (also known as nominal val-

QUALITY PROGRESS I OCTOBER 2007 I 49

QUALITY FUNCTION DEPLOYMENT

ues) of quality characteristics, reference is made to In this example, a chart is used to deploy all
specification values, actual performance and demanded qualities of the headlamp. All the
process capability of similar products developed in columns in the quality planning section are used to
the past. This is done to develop a product specifi- prioritize the demanded qualities that can support
cation tolerance with Six Sigma design quality and the company’s market positioning and that are con-
allocate the tolerance to related subsystems, com- sidered selling points. When demanded qualities
ponent units, parts and materials. are converted into substitute quality characteristics,
Moreover, DFSS also includes the design and R&D personnel must base the differentiation on tech-
verification of optimal process conditions and shop nical measures that can achieve the selling points.
floor management systems to ensure the manufac- For instance, to make sure the demanded quality
turing of semifinished products can achieve Six “lamp shines brightly” becomes a quality charac-
Sigma design quality. teristic, R&D personnel must determine a target
Using the quality deployment of a headlamp as value for the technical measure, transmissivity,
an example,13 Figure 3 shows QFD integrated with with a great difference from that of competitors’
the DFX and DFSS in Figure 2 (p. 49). headlamps and make it have significant brightness.

FIGURE 3 QFD Integrated With DFX and DFSS

Quality Flux distribution value Flux of light Efficiency Quality planning
characteristics Flux Low Bright- Deman-
distri- beam/ ness of Reflec- Color Air Competi- Abso- ded
bution Lens high Aiming light Trans- tion temper- Electric tight- Filament Impor- tive Planned Level- Selling lute quality
Demanded quality value size beam angle source missivity factor ature power Voltage ness strength tance analysis quality up rate points weight weight
Quality chart (two-dimensional matrix of demanded-quality deployment

Bright enough to see well

Can see distant objects
Lamp shines brightly
chart and quality characteristics deployment chart)

Broad beam
Quality planning for the
Shines with directional stability
Light does not scatter company’s market positioning
Can see close objects well and sales proposition
Low beam is bright enough
Broad beam
Shines with directional stability
Can see well even under adverse
conditions
Can see well in poor weather
conditions
Coordinates with steering wheel Design target setting for
Can see well even when vehicle
bounces
technical differentiation that
Direction of beam correct under can communicate the
no-load condition
company’s positioning

JIS ±4º
Specification nominal value require- 160 (up/down, 7.5 37.5/ 0.2 impact
ment ϕ 1º left/rigt) cd/mm2 0.9 min 0.9 min 3000ºK 50W 12.8 V a. p. 95º min
Tolerance design for Six Sigma
Specification tolerance quality by analyzing historical
process control data and
Headlamp
capability studies
Unit holding mechanism
Left retaining ring
deployment chart

Right retaining ring

Tolerance allocation to
Subsystems

Left mounting ring

Right mounting ring lower level characteristics
Bolt
Unit
Lens
Reflector
Product and process detail
Bulb design and verification
= Low corresponding strength
= Moderate corresponding strength
= High corresponding strength
JIS = Japanese industry standard
SAE = Society of Automotive Engineers

50 I OCTOBER 2007 I www.asq.org

 Assume we set the transmissivity value to be 0.9 Society for Quality Control), Vol. 13, No. 1, 1983, pp. 61-70.
minimum. As for the decision of the specification 12. Kano, “Attractive Quality and Must-be Quality,” see
tolerance for making 0.9 minimum, the nominal reference 1.
value, we can use the data on variance and process 13. Mizuno, Quality Function Deployment: A Company-
Wide Quality Approach, see reference 10.
capability obtained from the analysis of historical
process control data to calculate the tolerance
width required for Six Sigma quality. This toler- JUI-CHIN JIANG is an associate pro-
ance is then allocated to lower level characteristics fessor in the department of industrial
by simultaneously using the subsystems deploy- engineering at Chung Yuan Christian
ment chart.
University (CYCU) in Taiwan. He is
The development of the headlamp follows the
also the chair of the university’s quali-
remaining product and process development.
ty research center. Jiang has a doctor-
Meanwhile, other quality deployment charts are
used, and the Six Sigma target values are flowed ate in industrial engineering from
down to accomplish the detail designs and their Cleveland State University in Ohio.
verifications.
DFX and DFSS are two design methods that
have been used in recent years for effective new
product development. But, more and more, new MING-LI SHIU earned a doctorate in
product development requires combining the two. industrial engineering at CYCU.
QFD offers a structure for linking and integrating
them. It uses the resultant synergy to create an
advantage for product development.

REFERENCES

1. Noriaki Kano, Nobuhiko Seraku, FumioTakahashi and

MAO-HSIUNG TU is the president of
Shimichi Tsuji, “Attractive Quality and Must-be Quality,”
Quality (Journal of the Japanese Society for Quality Control), Vol.
D&N Business Consulting Co. in
14, No. 2, 1984, pp. 147-156. Hsin-Chu City, Taiwan. He received his
2. Ibid. MBA from City University of Seattle.
3. James Bralla, Design for Excellence, McGraw-Hill, 1996. He was formerly the chief corporate
4. Ibid. consultant of the companywide quality
5. David Garvin, “Competing on the Eight Dimensions of
improvement office of Philips Taiwan and won the Deming
Quality,” Harvard Business Review, November-December
1987, pp. 101-109. Application Prize in 1991 and the Japan Quality Medal
6. Noriaki Kano, “Quality Management in Management (Nihon Quality Control Prize) in 1997.
Engineering,” Quality, Vol. 17, No. 1, 1987, pp. 23-39.
7. Jiju Antony and Ricardo Banuelas, “Design for Six
Sigma,” Manufacturing Engineer, February 2002, pp. 24-26.
8. Gerald Hahn, Necip Doganaksoy and Roger Hoerl,
“The Evolution of Six Sigma,” Quality Engineering, Vol. 12,
No. 3, 2000, pp. 317-326.
9. Yoji Akao and Glenn Mazur, “The Leading Edge in QFD:
Past, Present and Future,” International Journal of Quality & Please
Reliability Management, Vol. 20, No. 1, 2003, pp. 20-35.
comment
10. Shigeru Mizuno and Yoji Akao (eds.), Quality Function
If you would like to comment on this article,
Deployment: A Company-Wide Quality Approach, JUSE Press,
please post your remarks on the Quality Progress
1978.
11. Yoji Akao, Tadatoshi Ono, Akira Harada, Hideharu Discussion Board at www.asq.org, or e-mail
Tanaka and Kazuo Iwasawa, “Quality Deployment Includ- them to editor@asq.org.
ing Cost, Reliability and Technology (part one)—Design of
Quality, Cost and Reliability,” Quality (Journal of the Japanese

QUALITY PROGRESS I OCTOBER 2007 I 51

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governing documents.
QUALITY IN THE
FIRST PERSON
Giving Credit Where Credit Is Due
hortly after retiring from the busi-
S
ness world, I had the opportunity
to spend several semesters as an
adjunct instructor in the school of busi-
ness at a small, local private college.
Among the classes I taught were an
introductory business course and an
operations management course.
While preparing to teach these cours-
es, I noticed the authors of the text-
books didn’t treat the subject of quality
in a manner equal to its importance. I
decided this could be an excellent
opportunity to make a small contribu-
tion toward improving the quality per-
spective in business course content.
Quality Knowledge
Several statements in the introduc-
tory business course textbook demon-
strated a rather superficial treatment
of quality. For example, in defining
total quality management (TQM), the
textbook stated, “TQM is sometimes
called quality assurance.” In another
instance, “quality reliability” was
used and defined as “consistency of a
product’s quality from unit to unit.”
With my background, I was able to
point out the inconsistencies between
the uses of these terms or definitions
as presented in the textbook and those
generally accepted by ASQ and others
in the quality field.
After teaching the introductory busi-
ness course for several semesters, I was
asked to teach the operations manage-
ment course. Although I had experience
in various operations management
positions, it was my first opportunity to
teach a course on the subject.
The dean supplied the textbook and
several past syllabi as references for
what needed to be covered. After my
experience with the other textbook, I
reviewed this one very carefully. I was
pleased to see that when describing
important trends in business in the
first chapter, the textbook used the
phrase “quality is now ingrained in
business.” However, I was disap-
pointed to see quality topics weren’t
covered until chapters nine and 10.
I requested and received permission
from the dean to modify the course
slightly and present it with beefed-up
quality content. Although prior class-
es had been taught in chapter
sequence, I changed the order. After
covering the introductory chapter on
A quality pro changes
a business course’s
perspective.
operations management, I skipped to
the quality chapters next. My reason-
ing was this:
• If quality is truly to be ingrained
in business, then the concepts of
quality should be introduced and
the basics taught prior to other
topics.
• Several significant quality con-
cepts were introduced in chapters
before the quality chapters. These
included quality function deploy-
ment, the Kano Model and other
general references.
Link to History
In the operations management text-
book, a picture caption quoted the
head of Toyota during a toast in 1982:
“There is no secret to how we learned
to do what we do—we learned it at
the Rouge.”
He was referring to Ford Motor
Co.’s River Rouge plant in Dearborn,
MI, one of the oldest automobile
plants in the United States. There was
only scant explanation of this com-
ment.
The prevalent view is that American
companies learned all the best tech-
niques from Japan. In class, I explained
that other sources1, 2 describe more of
the story. The resultant view, if one
looks far enough back in history, is that
American ingenuity had a positive
influence on Japanese manufacturing.
The primary source of that influence
was Henry Ford’s book, My Life and
Work. I first learned of the book during
a conversation with one of my peers in
graduate school, and I recently read a
copy.3
I saw firsthand that TQM, just-in-
by Ronnie Foster
time (JIT) and lean really do have
roots as far back as the early years of
Ford operations. Quite simply, Ameri-
can managers had strayed from prin-
ciples developed here in America and
had forgotten the past.
Rather than using the separate case
studies in the textbook, I used the
Ford book as a giant case study. I
asked the students to record their
understanding of Ford’s comments as
they related to a list of important
methods, such as TQM, JIT and lean.
I had them arrange Ford’s concepts
in a table set up in the three core ele-
ments of TQM: the customer, team-
work and continuous improvement.
The resulting student papers provid-
ed an illuminating graphic they
should not soon forget.
Given an opportunity to teach, I
chose to do so from a quality perspec-
tive, using my quality experience to
ensure an accurate presentation of the
material. By covering quality first, I
thought it would emphasize that qual-
ity basics should be understood before
attempting to ingrain them into an
operation.
Using material describing tech-
niques developed about a century
ago, I hoped to demonstrate that each
new generation should not spend its
time redeveloping the methods of the
past. Rather, these people should
understand them and, more wisely,
use their time improving them.
REFERENCES
1. James R. Evans and William M. Lindsey, The
Management and Control of Quality, South-
Western College Publishing, 1999.
2. George Alukal, “Create a Lean, Mean
Machine,” Quality Progress, April 2003.
3. Henry Ford, My Life and Work, Pro-
ject Gutenberg, E-Text number 7213, www.
gutenberg.org
RONNIE FOSTER is an
adjunct instructor at
Emmanuel College in
Franklin Springs, GA. He
is a retired engineer, man-
ager and consultant. Foster
has a master’s degree in
business from Indiana
University in Fort Wayne. He is a senior mem-
ber of ASQ and a certified manager of
quality/organizational excellence.
QUALITY PROGRESS I OCTOBER 2007 I 53
LEAN
LESSONS
In the Office: Where Lean
And Six Sigma Converge
L
ean thinking—focused on flow
and reducing nonvalue added
activities (waste or muda) that
impede flow—and Six Sigma—focused
on reducing process variability—can
come together when redesigning busi-
ness processes.
The nature of most business process-
es found in industrial and service
organizations clearly demonstrates
how lean thinking and Six Sigma
work in powerful combination.
Many people contend that variability
prevents lean from working in an
office setting and that variability can
negatively impact flow. There are
many examples of variability in busi-
ness processes.
For example, demand on most office
resources can be very unpredictable.
In addition, people involved in busi-
ness processes tend to multitask.
There can be many interruptions in
these activities in an office, adding to
variability.
The complexity of information can
vary—orders are not orders, quotes
are not quotes, and designs are not
designs. Most of this variability is
nonactionable, many believe.
However, the various lean tech-
niques, when properly applied, can
effectively address the root causes for
much of the variability in business
processes.
Common Causes of Variability
The most common cause for process
variability is the lack of standard
work practices. People have often
argued, “Why does it matter how
work is performed as long as it gets
done?” The fact is that it does make a
difference. Process variability can con-
tribute to variability in the output of
the process.
This situation is perpetuated when
new employees are brought into an
office. Without standardized work
practices, there cannot be standard-
ized training. Learning curves will
increase with the lack of standard
work practices. Information quality
also will decline.
54 I OCTOBER 2007 I www.asq.org
by Drew Locher
FIGURE 1 Batch Processing Example
Problem encountered Problem encountered
Batch of three.
Problem at any point in time
with one will have greater
impact on the other two.
Most likely, action must be
taken on all three to correct.
A major source of variability in
business processes relates to the quali-
ty of the information.
For example, people can complete
the same forms in different ways, per-
haps omitting important information.
This is commonly observed in office
environments.
Standardized work is a foundation
of lean thinking. Therefore, an initial
focus of a lean effort is to implement
true standard work practices through-
out a business process.
Demand Variability
Existing business practices artificial-
ly create a large portion of demand
variability. There are several possible
root causes, many of which can be
addressed. One of the common causes
for demand variability is associated
with batch processing, referring to the
manner in which work is completed.
If a business process is performed
infrequently (perhaps once a month),
the volume of work to be completed
in a period of time will be greater than
if the process was performed more
frequently.
Further, batch processing can have a
ripple effect through the various steps
within a business process as piles of
work are pushed through the process
step by step. Reducing batch sizes or
increasing the frequency of a task is a
Batch of one.
Problem with one should
have less impact on the
others that have yet to be
started. Most likely, action
must be taken on just one
to correct.
primary objective of lean since it
results in improved information flow.
Lean techniques help to control the
amount of work in process at any time,
reducing the impact of problems that
might arise (as shown in Figure 1) as
well as demand variability (Figure 2).
Another source of demand variabili-
ty is associated with when particular
activities are performed. Many orga-
nizations perform certain activities at
specific times on the calendar; for
example, financial related reporting
activities at the end of fiscal periods,
such as the end of a month.
Many of these activities can be per-
formed throughout the fiscal period
and do not have to wait until the end,
thereby leveling the workload. Leveling
workloads is a key concept of lean.
When applied, leveling can reduce
variability and provide important bene-
fits to the organization such as reduced
lead time and improved information
quality.
Still another source of demand vari-
ability relates to the organization’s
attempt to meet short-term perfor-
mance measures; for example, sales
revenues.
Often, organizations wait too long to
identify and react when they are in
danger of not meeting particular goals.
Lean enterprises have short man-
agement timeframes. In other words,
they frequently review performance
through simple and visual ways, and
they react in a timely manner to
address performance issues. This
practice will result in leveling perfor-
mance and demand over time.
Another source of variability comes
in the form of interruptions. Since
people working in an office environ-
ment perform multiple tasks, the
potential for unpredictable interrup-
tions increases. This can increase the
time to perform work as a person
must stop what he or she is doing to
tend to the interruption, and then
return to the task at a later time.
There are ways to manage interrup-
tions. This can relate to batch process-
ing. For example, an interruption will
have less impact if a person is work-
ing on one order at a time, rather than
five. In all likelihood, the person can
complete the order he or she is cur-
rently working on and then attend to
the interruption.
Another approach implemented in
an office environment has been referred
to as “a plan for every process”: Each
activity a person is expected to com-
plete is scheduled at a particular time.
An example is shown in Table 1.
This includes unscheduled “drop-in”
work or interruptions. In this way, the
interruptions can be dealt with at a
more convenient time. This is a form
of leveling the mix of activities that a
person performs. As previously men-
tioned, leveling of various forms is an
important concept in lean thinking.
Organizing for Flow
Many companies simply are not
organized in a way to effectively and
efficiently perform a business process.
Many companies are organized by
functions or departments with little
regard to the overall flow of informa-
tion.
For example, consider the following
order process:
• Order entered in customer service
department.
• Order sent to accounting for credit
check.
• Order sent to planning for the
scheduling of production.
Most companies will have in place
a process with multiple hand-offs as
the order makes its way from depart-
ment to department. Each hand-off
FIGURE 2 Controlling Workflow
Demand
Process A Maximum 3 Process B
FIFO
The use of pull systems in the form of first in first out (FIFO) lanes— which control the
amount of allowable work in process at any time—can help reduce the impact of
unleveled demand on the overall system. However, the root causes of demand variability
should still be addressed.
TABLE 1 “Plan for Every Process” Example
Time Monday Tuesday
9-9:30 a.m. Check e-mails Check e-mails
9:30–10 a.m.
Enter orders Enter orders
10–10:30 a.m.
10:30–11 a.m. Unscheduled work Unscheduled work
Enter return merchandise
11–11:30 a.m. Process holds
authorization forms
gives rise to a potential queue, as well FIGURE 3 Cross Functional
as the potential for information quali- Office Cell
ty problems to occur.
Lean thinking prompts you to con-
sider an alternative approach—to Engineering Order entry
organize by value streams and service
families. In this approach, required
resources are organized in a way to
maximize flow.
Often, this takes the form of cross
functional teams, sometimes located
in a cell as shown in Figure 3, to
process information in more effective
and efficient ways. In this way,
queues can be practically eliminated
and information quality improved,
along with other benefits. Accounting Sales
My experience with industrial and
service organizations shows the
results of the successful application of
lean to business processes are impres- DREW LOCHER is a
sive—a typical 90% reduction in lead principal of Change
time and up to a 40% decrease in Management Associates,
process time. The results are achieved a Mt. Laurel, NJ, con-
using lean and other improvement sulting firm that special-
approaches. izes in lean and quality
These efforts, primarily focused on management. Locher re-
ceived a master’s degree
the reduction in process variability,
in electrical and comput-
improve the predictability of the office
er engineering from Drexel University in
environment and improve the flow of Philadelphia and an MBA from Cornell
information. University in Ithaca, NY.
QUALITY PROGRESS I OCTOBER 2007 I 55
CAREER
CORNER
Use Business Cards Effectively
I
’m shocked at the number of people
who don’t carry a business card.
Even more amazing are those who
don’t even have cards. There is no
excuse for not having a business card to
offer when the situation calls for one.
Instead, always offer a card to anyone
who gives you his or her card and,
when appropriate, to anyone who
doesn’t have one to give you. Carry a
small notepad for recording contact
information from people who have no
card to offer. Don’t ask to use the back
of another person’s card to record your
information.
Don’t force your business card on
someone who doesn’t seem to want it.
Ask first if you may exchange cards.
Never give out a damaged business
card. Keep your cards in a business card
holder. Cards kept in a person’s wallet
often become bent or frayed.
Pick the appropriate time to exchange
business cards, such as when another
person offers you his or her card or sug-
gests an exchange, when you sense it’s
appropriate to suggest an exchange or
when the conversation appears to be
concluding.
Don’t just shove cards you receive into
your pocket without looking at them.
Make a point of commenting on some-
thing you read on them. Try to avoid
writing on the face of cards given to you.
If necessary, at a later time write perti-
nent data on the back of cards received.
After the Card Exchange
At your earliest convenience, retrieve
all cards collected at an event or for the
day. Review them and make notes, such
as what was discussed and the date and
place of the encounter.
Separate the cards into two cate-
gories: those you’ll keep for a short
period in case you need them for refer-
ence and those you will use to make
further contact.
If you are shy when meeting
strangers in a social or business setting,
exchanging business cards can trigger
conversation. Networking is key to
exposing others to your knowledge,
experience, skills, aptitude and attitude
(the KESAA factors), which can give
you an advantage in advancing your
career.
56 I OCTOBER 2007 I www.asq.org
Special Situations
Get your own business cards in any
of the following situations:
• You have left your job and are cur-
rently unemployed. (It’s misrepre-
sentation to use business cards from
a former job.)
Even seasoned
professionals can
brush up on this
basic formality.
• Your organization will not provide
cards for you.
• Cards furnished by your employer
don’t reflect the work you actually
do.
Note that you’ll probably need per-
mission to use your organization’s logo
or design. If you can’t get permission,
don’t use it.
Professionally printed cards, with fea-
tures such as raised printing and heavy
card stock, are fairly expensive but pro-
vide a quality impression. Don’t use
these cards after they’ve become obso-
lete just because they were expensive.
Double-sided and four-sided folded
cards can be professionally designed to
include résumé highlights or product
lines represented on the back or inside.
People expecting to work in an environ-
ment where another language is preva-
lent often have a translation of their
information on the reverse side of the
card. Commercially printed cards on
which information is oriented vertically
can attract attention but could annoy
the recipient when the card is filed.
Print Your Own
Printing your own business cards is
an option if you have a decent color
printer connected to your computer.
You can choose business card stock
from office supply retailers and pur-
chase an inexpensive, easy-to-use soft-
ware program to create attractive cards.
In this case, the card stock will not be
quite as heavy as commercially printed
cards, and the printing won’t be raised.
But, the big advantage is flexibility. You
can experiment with several designs,
type styles, colors and layouts on a vari-
by Russ Westcott
ety of stock—all at very little cost. (I
have five different cards I use for differ-
ent purposes. I can make changes
almost instantly.)
An added advantage is that you don’t
need to produce 500 cards—a typical
minimum order for commercially print-
ed cards.
Here are some tips when printing
cards or having them printed:
• Use easy-to-read fonts that are large
enough to not require magnifica-
tion.
• Avoid excessive bolding, italicizing
and underlining.
• Avoid printing in colors that are dif-
ficult to read.
• Be sure contact information is clear
and readable.
Unemployed people might balk at
showing a title on their temporary busi-
ness cards. If you can’t invent a title
with which you are comfortable, don’t
use one. Be sure any title you use
reflects your competency and the orga-
nizational level to which you aspire.
Don’t use “consultant” unless you are
actually soliciting or doing consulting
work. The title could provoke an
inquiry, and you will want to tell the
truth. Avoid using a company name,
unless you are currently consulting
under that name.
If and how you present your business
card tells a lot about your professional
image, respect for others and networking
competence. Having your business card
available at all times is a reciprocal action,
a thoughtful gesture, a professional cour-
tesy and a worthwhile investment.
RUSSELL T. WESTCOTT
is an ASQ fellow, certified
quality auditor and certi-
fied manager of quality/
organizational excellence
(CMQ/OE). He is editor of
the third edition of the
CMQ/OE Handbook,
co-editor of the Quality
Improvement Handbook and author of
Simplified Project Management for Quality
Professionals and Stepping Up to ISO
9004:2000. Westcott is also a co-instructor of the
ASQ CMQ/OE refresher course. Based in Old
Saybrook, CT, he owns the Offerjost-Westcott
Group, a work-life planning and career coaching
firm.
STATISTICS
ROUNDTABLE

When Should You Consider

A Split-Plot Design?
by Christine M. Anderson-Cook

f you conduct experiments, a good ment in which a number of adjacent three columns of Table 1.

I understanding of design of experi-

ments (DoE) can be beneficial for
maximizing the information you can
obtain on a fixed budget.
plots of land all receive the same fer-
tilizer (the whole-plot factor) and then
the particular seed type (subplot fac-
tor) is randomized and applied to
A split-plot experiment is one plots within that larger grouping. The
option to consider, especially if you
have a situation in which some factors
have levels more difficult to change
than others. In these experiments, The approach can
some of the factors (the hard-to-
change ones) are intentionally reset boost the amount of
less often than the easy-to-change fac- information extracted
tors. In a completely randomized
experiment, all factors are reset an from a designed
equal number of times.
experiment.
Split-Plot Basics
Despite their utility, split-plot
designs are frequently given only number of whole plots (#WP) corre-
superficial coverage in an introducto- sponds to the number of times you
ry statistics or DoE course. For that reset the whole plot factors, while the
reason, some background is warrant- total number of the experiments (N) is
ed. equal to the number of subplots, since
Since split-plots originated in agri- you reset the subplot factors after
cultural settings, much of the nomen- each run.
clature refers to plots of land: The In an industrial setting, the hard-to-
hard-to-change factors are called change or whole plot factors might be
whole-plot factors, while the easier-to- changing the temperature of an oven
change factors are called subplot fac- (which then needs to reach an equilib-
tors. rium temperature before being used),
Imagine an agricultural field experi- setting up complex equipment or mix-
ing up batches of ingredients. The
metric for quantifying hard-to-change
TABLE 1 A 23Full Factorial factors could be based on budget or
Experiment in time.
Standard Order
More Trouble Than It’s Worth?
Potential While these designs might seem
X1 X2 X3 much more complicated than a com-
run order
pletely randomized design, there are a
+1 +1 +1 6 number of implementation and statis-
+1 +1 -1 1 tical advantages to running this type
+1 -1 +1 5 of experiment.
Consider this simple example:
+1 -1 -1 2 Suppose you’re interested in studying
-1 +1 +1 3 the effects of three factors (X1, X2 and
-1 +1 -1 4 X3) on a response through a 2 3 full
factorial screening experiment. This
-1 -1 +1 7
design involves eight runs, which are
-1 -1 -1 8 listed in standard order in the first
Recall that for a completely ran-
domized designed (CRD) experiment,
you randomize the order of the eight
runs (a potential run order is shown
in the fourth column of Table 1). Then
between each run, the levels of each
factor are reset.
For practical purposes, the experi-
menter might sometimes fail to reset
all of the factors between runs. For
example, between runs 1 (+1, +1 and
+1) and 2 (+1, -1 and -1), the experi-
menter might just keep X1 set at its
current level since it does not change
between the two runs. Between runs 7
(-1, -1 and +1) and 8 (-1, -1 and -1), the
experimenter might not reset X1 and
X2 since they remain at the same lev-
els.
This is referred to as an inadvertent
split-plot. 1 In this case, a split-plot
experiment has actually been run, but
when it is analyzed it might be mis-
takenly treated as a CRD. This analy-
sis would treat all the runs as
independent, which is not appropriate
and could lead to misleading conclu-
sions about factor effects. The results
could either erroneously declare a fac-
tor statistically significant or not sig-
nificant when it actually is important.
Order in the Experiment
If the experimenter does not wish to
reset all of the factors between runs, it
makes more sense to intentionally
choose a desirable split-plot experi-
ment in which the same eight runs
might be used, but their order has
been carefully considered. This would
not mean that you omit the random-
ization step, but rather that the form
of the randomization would be more
structured.
Of course, it will also be important
to analyze the data as a split-plot
experiment. This will lead to valid
conclusions that give accurate infor-
mation about the effects. The new
releases of analytical packages from

QUALITY PROGRESS I OCTOBER 2007 I 57

 ARE YOU
PREPARED?
How to be Audit Ready
Being prepared for your audit
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and mean the difference in
receiving a PASS or FAIL.
BSI Management Systems
would like to help you become
better prepared by offering
you a complimentary
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This document:
• Explains the difference
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• Offers additional information
on how BSI can help
To receive this useful and
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www.bsiamericas.com/qp
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58 I OCTOBER 2007 I www.asq.org
STATISTICS
ROUNDTABLE
JMP and Design Expert make select-
ing a good split-plot experiment and
performing the appropriate analysis
trary “leave it to chance” approach
has high potential to disappoint.
Sometimes it is possible to outper-
much easier. form the estimation and prediction
The correct analysis acknowledges performance of a CRD by choosing to
that observations obtained without do the right split-plot experiment. In
resetting the whole plot factor are cor- many situations, a split-plot experi-
related with each other, as you would ment can yield more precise model
expect them to be more similar than parameter estimates than the same
observations that involved resetting sized experiment run as a CRD.3
all the factors. For example, for the one hard-to-
When determining the run order of change and two easy-to-change factor
the split-plot experiment, there are experiments discussed earlier, the
two separate randomizations: deter- design with the highest D-efficiency is
mine the order in which you run the the one shown in Table 2. Again, it
whole plots; and collect observations would be important to randomize the
within each whole plot. run order of the four whole plots, and
This leads to two error terms in the then the order of the two runs within
model, which affect not only how the each whole plot.
analysis should be performed, but
also how different designs compare Weighing the Options
depending on the relative size of the If you take the cost of the experi-
error terms. The good news is that ment into consideration, it might be
many of the classical design choices even easier to justify this type of
are quite robust to differentiate the experiment. If the hard-to-change fac-
relative size of the two error terms. tors are expensive or time-consuming
to change, then selecting a design that
contains fewer whole plots could rep-
resent a potentially large savings.
TABLE 2 The D-Optimal There are approaches for quantify-
Split-Plot Design ing the relative cost of experiments in
which the total cost is assumed to be
Whole plot proportional to a weighted sum of the
X1 X2 X3
number
number of whole-plots (#WP), and the
+1 +1 +1 1 total number of observations (N):
+1 -1 -1 1 C
#WP + rN in which r = CSP/CWP is
the relative cost of changing a subplot
+1 -1 +1 2
factor compared to changing a whole
+1 +1 -1 2 plot factor.4, 5 Included in the cost of
-1 +1 +1 3 the subplot factor is the cost of mea-
-1 -1 -1 3 suring the responses for each observa-
tion.
-1 -1 +1 4
For example, an r value of 0.5
-1 +1 -1 4 would mean that the cost of changing
the subfactor level setting would be
half of the cost of changing the whole
plot factor level. Often, it is difficult to
Researchers considered the example estimate the actual cost of these two
discussed earlier and examined how changes, but their relative costs might
likely an experimenter would be to be more easily approximated.
obtain a reasonable design in terms of The earlier cost based metric can be
good statistical properties using the used in combination with the quality
inadvertent split-plot approach.2 of estimation (D-criterion) or predic-
Depending on whether estimation tion (IV- or G- criteria) to compare
(D-optimality) or prediction (I- or G- potential designs. Sometimes the
optimality) are important, the inad- hard-to-change factors are extremely
vertent split-plot can yield a design difficult or expensive to change rela-
that is only 50% as efficient as the best tive to reseting the subplot factors
choice of groupings of observations (here r  0). In this case, adding more
into whole plots. Clearly, this arbi- observations within each whole plot is
relatively cheap, and the total cost of
the experiment is driven almost
entirely by the number of times that
the hard-to-change factors need to be
reset, namely the number of whole
plots.
In other cases, the relative difference
between the cost of changing the
hard-to-change and easier-to-change
factors is more moderate (for exam-
ple, r between 0.1 and 1). In this case,
the total cost of the experiment is a
weighted function of the number of
resets of both of these factors.
Clearly, different designs should be
considered depending on the relative
costs of changing the factors. While
combining the cost and quality of the
design into a single metric is not
always appropriate, it frequently
might allow for more realistic com-
parisons and help facilitate decision
making.
The Right Design
As with CRDs, there are a number
of different aspects that should be
considered when choosing a good
design. There is a breadth of aspects—
from qualitative characteristics (such
as balance for the number of observa-
tions per whole plot and the number
of levels of each factor) to quantitative
measures (such as good estimation of
the whole plot and subplot error
terms, and relative performance based
on optimality criteria).6
Since different experiments have
different priorities, it is important to
consider what “optimal” means for an
experiment and to focus on the crite-
ria most relevant to project goals.
There are classes of split-plot designs
called equivalent designs that allow
for estimation of parameters using
ordinary least squares instead of
restricted maximum likelihood esti-
mation.7
One of the primary advantages of
these designs is that the parameters of
the mean model can be estimated sep-
arately from the whole-plot and sub-
plot error terms, which are frequently
not easy to estimate precisely.
Split-plot designs are an important,
practical class of designs. When
strategically chosen, split-plot designs
can boost the amount of information a
practitioner can extract from a
designed experiment.
REFERENCES
1. Jitendra Ganju and J.M. Lucas, “Detecting
Randomization Restrictions Caused by Factors,”
Journal of Statistical Planning and Inference, Vol. 81,
1999, pp. 129-140.
2. Li Liang, C.M. Anderson-Cook and T.J.
Robinson, “Cost Penalized Estimation and
Prediction Evaluation for Split-Plot Design,”
Quality and Reliability Engineering International,
Vol. 23, No. 5, 2007, pp. 577-596.
3. Peter Goos and Martina Vandebroek,
“Outperforming Completely Randomized
Designs,” Journal of Quality Technology, Vol. 36,
No. 1, 2004 pp. 12-26.
4. Søren Bisgaard, “The Design and Analysis
of 2 k--p x 2 q--r Split-Plot Experiments,” Journal of
Quality Technology, Vol. 32, No. 1, 2000, pp. 39-56.
5. Li Liang, C.M. Anderson-Cook and T.J.
Robinson, “Cost Penalized Estimation and
Prediction Evaluation for Split-Plot Design,” see
reference 2.
6. P.A. Parker, C.M. Anderson-Cook, T.J.
Robinson and Li Liang, “Robust Split-Plot
Designs,” Quality and Reliability Engineering
International, Vol. 23, 2007.
7. P.A. Parker, S.M. Kowalski and G.G.
Vining, “Classes of Split-Plot Response Surface
Designs for Equivalent Estimation,” Quality and
Reliability Engineering International, Vol. 22, 2006,
pp. 291-305.
ADDITIONAL RESOURCES
Montgomery, D.C., Design and Analysis of
Experiments, Wiley, 2006.
Goos, Peter, The Optimal Design of Blocked and
Split-Plot Experiments, Springer, 2002.
CHRISTINE M. ANDERSON-COOK is a tech-
nical staff member of Los Alamos National
Laboratory in Los
Alamos, NM. She earn-
ed a doctorate in statis-
tics from the University
of Waterloo in Ontario,
Canada. Anderson-Cook
is a senior member of
ASQ.
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.
QUALITY PROGRESS I OCTOBER 2007 I 59
STANDARDS
OUTLOOK
Output Really Does Matter
by John E. “Jack” West
uditing is a key component of
A systems that provide confi-
dence in organizations’ compe-
tence, ability and honesty in meeting
requirements. For decades we have
been using audits for this purpose,
and it can be argued that the concept
has generally worked well.
Positive audit results usually reflect
reality and generate confidence. This
is true whether it relates to finances,
environmental issues, quality or other
areas.
Why then are we sometimes disap-
pointed to learn that an organization
with a quality management system
(QMS) certified to ISO 9001 has major
problems delivering products that
meet customer requirements?
Similar questions can be asked
about financial, health and safety, and
environmental auditing. The basic
question is can QMS audits reliably
predict future QMS performance?
Perhaps more broadly we might ask
whether QMS auditing ever can pro-
vide complete assurance that cus-
tomer requirements will be met.
Certainly the generic answer for many
years has been a qualified no.
The product certification process
indicates that the rigorous way to
know a product conforms is to have a
lab inspect or test a sample using
agreed upon criteria. This philosophy
tells us that if the sample meets the
criteria, we should be able to rely on
the producer’s QMS to ensure consis-
tent conformity over time. ISO 9001,
with its focus on control of processes,
is a great tool to help organizations
consistently meet requirements.
Limitations of Product
Inspection and Testing
Of course, for some products the
risks associated with potential failures
drive us to test or inspect every item.
But for the most part, we rely on more
limited inspection and testing plus the
controls of the QMS. Here’s the rub:
Even for supposedly high reliability,
high risk items, it is generally impos-
sible to inspect or test for everything
60 I OCTOBER 2007 I www.asq.org
that could cause failure.
Anyone who has ever used failure
mode effects analysis (FMEA) has
examples of this. Perhaps we are
forced by practicality and economics
to focus on potential failure causes
that have high risk priority numbers.
Even for simple products and ser-
vices, all of this seems technical and
Auditors should focus
on what affects
customers.
complicated. In my experience, most
real product failures are caused by
simple things that could have easily
been avoided during design or pro-
duction.
In fact, my experience also includes
many cases in which recalls and cata-
strophes have been prevented because
a lowly quality auditor asked a simple
question that seemed stupid to those
listening. We need more QMS audi-
tors to ask these basic questions.
Reliance on Records
Audits, like lab tests of samples, are
snapshots in time. Only a review of
records can show what happened
before the audit. So we are forced to
rely on records that might or might not
be designed to reveal problems and
that might or might not have been
competently and honestly completed.
Most audit systems are quite loose
in determining how much recorded
history is reviewed to determine
process stability. Audits of stable
processes can verify past stability and
predict future stable performance.
Audits of processes that are either
known to be unstable or not known to
be stable see performance only at the
time of the audit. They offer no ability
to predict future success or failure of
the process.
Expert auditors can recognize a
great system quickly, and easily find
the holes in any marginal system. But
such expertise is not universal, and
expert auditors seldom want to work
for the third-party auditor’s day rate.
Organizations also aren’t eager to
assign their best and brightest people
to conduct internal audits.
Even with expert auditors and real-
ly good systems, all it takes to cause
product failure or recall is for the
organization to fail to meet one key
characteristic.
Ask the Right Questions
Auditors need to ask probing but
basic questions. For a toy manufactur-
er, the question might be, “How do
you know that coating is nontoxic?”
or “How do you ensure very young
kids can’t swallow these small parts?”
The representative of the organiza-
tion being audited might think the
answer is “Isn’t it obvious?” But when
pressed for objective evidence, the
organization might be forced to
change its coating or parts design.
When this happens, chalk up anoth-
er audit-produced success. Auditors
who ask such questions should be
encouraged. The ones who force pre-
ventive change probably should be
designated heroes.
A story related to me by a course
attendee a couple of years ago illus-
trates the importance of watching for
the little things (see “Auditing Success
Story,” p. 62). Stories like this abound
when auditors use the right approach
to each audit they conduct.
Careful Planning Needed
This means auditors need to careful-
ly plan each audit. Even if an auditor
has audited the same organization
several times, conditions and pres-
sures change. Successful auditors
spend time planning so the right
questions get answered.
Data analysis in preparation for
audits is often inadequate to determine
the areas of most improvement oppor-
tunity. In fact, the data might not be
made available and, in many cases, the
auditor might not know to ask for it.
Aggregation of hard data (for exam-
ple, customer feedback, internal data
and cost data) with audit observations
(not findings) is often inadequate for
defining areas in which the data and
observations taken together demon-
strate problems or show excellent per-
formance. ISO 9001 requires a lot
more data and analysis than prior
QMS standards, so auditors should
ask for data and use it.
Rigorous system audits can provide
confidence that the system has suc-
cessfully produced conforming prod-
uct in the past, and audits can also be
good at finding problems. But with-
out a great deal of analysis, it is hard
to determine what effect the problems
will have on future product—even if
conditions don’t change.
Prediction and Change
The predictive nature of audit
results is questionable since change is
occurring all around (and within) the
system. Control of the system changes
(ISO 9001, clause 5.2.4 b) is quite diffi-
cult to audit under the best of circum-
stances and can be a source of strong
rebuttals—even heated arguments—
from auditees. So this area is often not
pursued aggressively.
Sometimes the apparently minor
problems have the most significant
future negative impact. For example,
if a job is normally done by temporary
workers who are trained each day, it
would seem to be a minor issue if the
work is being done by the most expe-
rienced permanent employee on the
day of the audit.
But after the customer complains, we
could discover that this experienced
person has never been trained to do
the particular work involved. Such
minor things might even go unreport-
ed and only become a big deal after a
major customer issue is raised.
A situation like this could easily
lead to the conclusion that audits by
themselves are not likely to be good
predictors of future system perfor-
mance. In my experience, however,
organizations that focus their systems
on achieving capable processes for
product realization and that have
strong top management involvement
seem to have better long-term records
of success.
In these situations, audits are an
ideal way to ensure ongoing process
stability and control—as long as the
auditors know how to look for signs
of deterioration.
Some argue that if this type of
observation could be validated, crite-
ria could be developed to determine a
fairly small number of system ele-
ments that are predictors of future
success. But this has proven illusive
because organizations that do these
critical few things well tend to also do
the rest of the system well.
Suggestions for Successful
QMS Audit Programs
Perhaps sustainable success is possi-
ble only by doing everything well.
What then should those who manage
QMS audit programs do? Here are
several ideas:
• Select the right people—the best
and brightest—to do the auditing.
Pick people with inquisitive minds
and enough product knowledge to
ask the right basic questions.
• Provide time prior to audits for
the auditor or team to collect and
analyze operational data on the
areas and processes to be audited.
This analysis and planning should
help focus the audit. Part of the
audit objective should be to verify
the areas being audited are them-
selves collecting and analyzing the
right data.
• Have auditors aggressively pursue
issues related to change. This
means that before the audit starts,
auditors need to have studied the
change related pressures on the
area to be audited and the nature
of changes going on there. Never
acquiesce to complaints that, “This
is not a good time for the audit. We
are in the midst of change. Come
back in six months.” The midst of
About
?
Questions
Standards
Send your general questions
about quality and environmen-
tal management system stan-
dards and their derivatives to
standardsquestions@asq.org.
Include your daytime phone
number and e-mail address.
The questions will be submit-
ted to one of QP’s regular
“Standards Outlook” colum-
nists. Look for answers to
appear in future issues of QP.
change might be the best time to
audit.
• Provide time during or after the
audit for analysis of the auditor or
audit team’s observations against
the operational data collected in
preparation for the audit. Ask
whether the organization already
knows about the concerns and is
working on them. This should
help focus findings on new issues
that are not being addressed.
• Train auditors to focus on obtain-
ing facts and supporting data.
When possible, get auditors
to state issues in terms of potential
cost savings or monetary risk.
Teach them enough statistics that
they can conduct sufficient sam-
pling and recognize whether
processes are statistically in con-
trol and capable.
QUALITY PROGRESS I OCTOBER 2007 I 61
STANDARDS
OUTLOOK
• Review or discuss auditors’ obser-
vations with them before they
write up their findings. This can
be a tricky issue because the audi-
tors could get the notion that you
want to restrain their freedom. So,
organizations should ask probing
questions and remember that the
objective is to get the stupid ques-
tions asked, not to explain the
answers.
• Perhaps most important of all,
focus observations on the product,
customer or business perfor-
mance, no matter where in the
QMS they occur. For some require-
ments, such as those related to
product realization, the link to the
customer is obvious.
But QMS standards have require-
ments in many areas, such as
management responsibility and
resource management, that are
often looked at out of context. Put
these requirements into the con-
text of how the organization
ensures conforming product, cus-
tomer satisfaction and business
performance. What will be the
potential affect on the customer if
this situation goes unchanged?
For example, management-
review records often mainly
report past activities or status of
projects. In such cases, the auditor
should ask how management
review is being used to identify
needed product improvements
that could increase sales. Any
issue related to business perfor-
mance and customers can get top
managers excited about changing
the status quo.
• Worry less about whether auditors
are experts in a particular QMS
standard than about other things
that are important. Worry more
about how well the organization is
meeting customer requirements
and satisfying customers than
about how it conforms to every lit-
tle requirement of the applicable
QMS standard.
It is said, correctly I think, that 80%
of what businesses do is common to
all, while 20% differs by individual
industry and organization. So, all audi-
tors should be able to do a good job
with the 80%. The trap lies in the 20%.
The bottom line is that audit pro-
62 I OCTOBER 2007 I www.asq.org
Auditing Success Story
An organization had outsourced the manufacture of some com-
ponents to a company in a developing country.
The process capability for making one of the components was
extremely poor. The manufacturing engineer decided to install a
second piece of equipment to perform a rework operation because
the primary operation had a defect rate approaching 50%.
This new equipment worked fine, but the engineer was not satis-
fied because the rework took three times longer than the primary
operation.
To understand why the primary operation was not capable of
meeting requirements without rework, the engineer asked the
operator to prepare a control chart of operation results.
The person running this small cell had not only been trained to
make control charts, but she had also learned about records of
conformity. An auditor from the purchasing company watched the
operator and discovered she was charting results only after rework
was completed. Naturally, this defeated the intended purpose of
the chart.
What is significant is that both the engineer and the operator’s
supervisor had noticed the data were all well within specification,
and no one had asked the operator how this could be.
After the auditor reported her findings to the plant manager, she
concluded the organization had a major communications problem
between supervisors and operators and between the manufactur-
ing engineers and production.
It took a while for this to be addressed and fixed, but this one lit-
tle auditing observation resulted in a complete turnaround in that
plant’s methods of communicating and operating. —J.W.
grams need to sweat the basic little
Please
details that impact customers. This comment
requires great auditors.
If you would like to comment on this
JOHN E. “JACK” WEST article, please post your remarks on
is a management consul- the Quality Progress Discussion
tant and business advi- Board at www.asq.org, or e-mail
sor. He served on the
board of examiners for them to editor@asq.org.
the Malcolm Baldrige
National Quality Award
from 1990 to 1993 and is
past chair of the U.S.
technical advisory group to ISO technical com-
mittee 176 and lead delegate to the committee
responsible for the ISO 9000 family of quality
management standards. He is an ASQ fellow
and co-author of several ASQ Quality Press
books.
 QP
TOOLBOX
L.J. Star’s Light Illuminates
Sanitary Equipment
The Lumi-View 35 fiber optic light from
L.J. Star is an illumination system for san-
itary processing equipment. It provides up
to 50W of illumination while allowing
viewing through the same equipment
window. This combination of sight and
light glass can be used to view the interior
of either new or existing sanitary process-
ing equipment.
The Lumi-View 35 attaches directly to
the sight glass, eliminating separate
mounting of the light source. The housing
is made of 316 stainless steel. An internal
transformer allows for a 120 volts power
supply; however other voltage supplies
are available.
Call: 330-405-3040; visit: www.ljstar.
com.
Hazardous Area Vibration
Sensors Prevent Explosions
Wilcoxon Research has introduced a
line of hazardous area vibration sensors
with intrinsic safety (IS) certification. IS
certification means the sensors can be
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Mahr Federal’s
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Digimar 817 CLM
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Call: 800-945-2696; visit:
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Digimar 817 CLM
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▼
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The Digimar 817 CLM also features an
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Call: 800-333-4243; visit: www.mahr.com.
KNF Clean Room Products
Releases Packaging Line
KNF Clean Room Products has released
a line of Ultraclean Film packaging. Its
Kenylon brand of nylon products is for
clean packaging applications, specifically
for products with sharp or protruding
parts. Kenylon’s brand of film products is
heat resistant, moisture permeable and
puncture resistant.
The Ultraclean Film packaging lines are
best suited for aerospace, semiconductor
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best suited for pharmaceutical applica-
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Call: 800-777-2532; e-mail: sales@
knfcorporation.com.
PTFE Coupling Added
To Fluor-O-Flo System
Micromold has added a cam lock,
quick connect, polytetrafluoroethylene
(PTFE) coupling to its line of Fluor-O-Flo
threaded piping system components. The
coupling is designed for applications
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The coupling provides an attachment
point for components that must be periodi-
cally removed or replaced. They are avail-
able in pipe sizes ranging from 1/2" to 4"
with male and female national pipe taper
thread connection options. The cam locking
levers are stainless steel and replaceable.
Call: 914-969-2850; visit: www.
micromold.com.
Data Loggers Monitor
Temperature and Humidity
The TandD model TR-71W and TR-72W
thermo recorders are data loggers incor-
porating an integrated ethernet and local
area network interface for monitoring
both temperature and humidity. These
capabilities allow for collection of record-
ed data and monitoring of current condi-
tions. The TR-71W can send warning
e-mails and text messages to cell phones.
The TR-71W is a temperature data logger
with a range of -40° C to 110° C with option-
al sensors available with a range from -60°
C to 155° C. The TR-72W is a temperature
and humidity data logger with a range of 0°
C to 50° C and 10% to 95% relative humidity.
Call: 518-669-9227; e-mail: inquiries@
tandd.com.
Dashboard Software
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May International, through a partner-
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Management Dashboards, a software
package specifically designed for use with
QuickBooks and other databases used by
smaller manufacturing companies. The
software can be customized so that infor-
mation is accessible by authorized users
with an internet connection.
Management Dashboards can display
and track key performance indicators and
data, including work-in-progress status,
production schedules, incoming orders,
shipping status and production backlog.
The software can also be used to track
departments such as sales, HR and cus-
tomer service.
Call: 847-993-5443; e-mail: info@
gsmdashboards.com. QP
QUALITY PROGRESS I OCTOBER 2007 I 63
 QP
REVIEWS
Introduction to
Statistical Engineering
S.J. Morrison, BookForce UK, Ltd., 2006,
209 pp., $40.96 (book).
Introduction to Statistical Engineer-
ing is a statistical textbook covering
all the concepts of basic statistics but
using applications from engineering
as its applied framework. Beyond the
examples given, Morrison grounds
the discussion of statistical and proba-
bility concepts within engineering
very well.
The book is aimed at engineers, not
statisticians; therefore, topics are cov-
ered without the need to know calcu-
lus. Early chapters’ topics include
basic statistics and important statisti-
cal distributions, quality control in
terms of cumulative sum and control
charts, and simple linear regression
and analysis of variance.
In addition, there are chapters on
design of experiments and research
and development that focus on the
types of studies important in engineer-
ing. Finally, the author covers some
topics in quality management. The
conclusion and appendixes provide
references and guidelines for further—
more advanced—study.
The book is an easy read—even for
the nonhands-on engineer—and it is
clear that the examples were chosen
carefully to illustrate both statistical
ideas and engineering applicability.
For engineers or other quality experts
who are not statisticians, this book
would make a good reference text.
The only minor flaw is that the type
quality of the book is variable. Many of
the charts and figures are quite rough-
ly drawn but other aspects such as
tables and equations are easy to read.
A new edition—should there be one—
would benefit from upgraded charts
and figures.
I. Elaine Allen
Babson College
Wellesley, MA
Applying the Science
Of Six Sigma
Michael J. Pestorius, ASQ Quality Press,
136 pp., $28.35 member, $47.25 list (book).
Any book combining statistics and
sales is sure to scare all but the most
64 I OCTOBER 2007 I www.asq.org
enlightened sales and marketing per-
son. Crossing the great divide be-
tween the left and right brain is simply
a journey many in that role are not
willing to take. However, with
Applying the Science of Six Sigma to
the Art of Sales and Marketing as their
guidebook, all but the most frightened
will be just fine.
Written in a style that does not talk
down to readers, Pestorius dedicates
a few pages to the origins and myths
surrounding Six Sigma. He then
shows the reader how to apply the
define, measure, analyze, improve
and control concept to sales and mar-
keting challenges. For example, the
chapter on sales territory planning
provides a way for sales managers to
develop customer segmentation rou-
tines based on statistical analysis.
In another chapter, Pestorius
applies the predictive nature of Six
Sigma to the sales representative hir-
ing process. The book offers different
methods to make sound, fact-based
sales and marketing decisions.
The application of statistics to the
sales process is not new. Many pow-
erful tools, including regression analy-
sis, have been used extensively to
develop successful market segmenta-
tion schemes. What Pestorius has
added to the conversation is a sound
explanation of how a process driven
approach like Six Sigma can improve
the sales performance of organiza-
tions large and small.
Tim Knight
Evergreen Park, IL
The Magic of
Self-Directed Work Teams
Paul C. Palmes, ASQ Quality Press, 2006,
128 pp., $28.35 member, $47.25 list (book).
The Magic of Self-Directed Work
Teams: A Case Study in Courage and
Culture Change is a detailed case
study charting change and develop-
ment at a real company—Northern
Pipe Products—as it introduced self-
directed work teams. This interesting,
insider narrative provides information
on financial, operating and other indi-
cators in a five-year chronological
examination of the successful intro-
duction, implementation of new man-
agement practices and how they were
sustained. The book reads like a novel
in that the reader feels as if he or she
are taking the journey along with the
author. The story is laid out in three
stages: the old culture, out of the dark-
ness and a new commitment.
The context of the story is very
detailed. The problems that Northern
Pipe Products encountered seem
overwhelming, but Palmes leads the
readers through their decisions when
addressing every issue. This involves
fascinating insights from all levels of
the organization. The tools and tech-
niques used are presented and then
followed by what worked and what
did not. Finally, the return on invest-
ment and the cost of quality is exam-
ined.
The book clearly shows the lessons
learned at Northern Pipe Products are
transferable to any organization in
any industry. This is an inspirational
and excellent case study showing
how, specifically, self-directed work
teams should be employed. But also
on a higher level, it shows how quali-
ty management can be adopted to
make a significant impact.
Denis Leonard,
Veridian Homes
Madison, WI
Accelerated Quality
And Reliability Solutions
Lev M. Klyatis and Eugene L. Klyatis,
Elsevier Science, 2006, 544 pp., $160
(book).
Are you frustrated that your reliabil-
ity testing efforts don’t seem to effec-
tively uncover product weaknesses
prior to release? Is a lack of test equip-
ment or methods to simulate field
conditions a problem in your valida-
tion process? Accelerated Quality and
Reliability Solutions provides the
tools to address these questions and
more.
This book covers various methods
of validation testing and reveals
through numerous examples the
weaknesses in many current test pro-
grams. Primary to the authors’ experi-
ences is the fact that most testing does
not account for environmental condi-
tions seen in the field, especially the
interactive effects of various factors.
Thus, most validation testing done
today is ineffective in revealing design
weaknesses.
 The authors spend a great deal of
time detailing how to develop models
for environmental conditions. Some
development of mathematical models
for interactive effects is provided,
along with discussion and examples.
I found the book to be a difficult
read. There are many sentence frag-
ments and outright grammatical
errors. There is too much repetition
and the text does not seem to follow a
logical progression.
Reliability professionals may find
this book an interesting read and may
find some valuable insight with
respect to modeling for environmen-
tal testing factors. Quality profession-
als not already familiar with reliability
and validation testing would not find
this book to be a valuable addition to
their quality tool chest.
Bryan Ruggles
Boeing Commercial Aircraft
Everett, WA
audits, and one on auditing the core
R E C E N T R E L E A S E S
automotive tools. A CD-ROM accom-
panies the book. It includes an audit
checklist for ISO 9001, ISO/TS 16949, Strategic Benchmarking
ISO 14001 and ISO 18001. These are Reloaded with Six Sigma,
some of the better checklists I have
seen for auditing, and they alone are Gregory H. Watson, John Wiley & Sons,
worth the cost of the book. 2007, 360 pp., $45 (book).
I found this book to be worthwhile
reading. It got better as I got further
into it. The book does discuss some
rudimentary subjects, but the reader
Business Process Change: A
should get beyond those and absorb Guide for Business Managers
some fresh ideas and principles the and BPM and Six Sigma Pro-
author has to offer.
fessionals, second edition, Paul
Wayne Sander Harmon, Morgan Kaufmann, 2007,
Dove Quality Consulting
548 pp., $49.95 (book).
Dousman, WI
Treasure Chest of Six Sigma
Growth Methods, Tools, and
Best Practices, Lynne Hambleton,
Prentice Hall, 2007, 995 pp., $89 (book). QP

The Management System

Auditor’s Handbook
Joe Kausek, ASQ Quality Press, 2006,
432 pp., $59.85 member, $99.75 list (book
and CD-ROM).

In the past I have read many audit-

ing books that have explained and re-
explained how to plan an audit,
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QUALITY PROGRESS I OCTOBER 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, 800-248-1946,
414-272-8575, fax 414-272-1734, website
www.asq.org.
N O V E M B E R
5-9 ASQ Conference. National Quality
Education Conference. St. Louis.
5-9 ASQ Education Course. Certified
Quality Engineer Exam Preparation.
Toronto.
7 SPE Automotive Innovation Awards.
Detroit. Call the Society of Plastics Engi-
neers at 248-941-9368 or visit www.4spe.
org.
8 5th Annual Conference for FDA Reg-
ulated Industries. Farmingdale, NY. Call
Rick Calabrese at 631-254-4249 x8371 or
e-mail rick.calabrese@sartorius.com.
8-9 Product Safety and Liability Pre-
vention. Milwaukee. E-mail Randy
Goodden at rgoodden@go.com or visit
http://randallgoodden.com.
12-13 ASQ Education Course. 16-hour
ISO 9001:2000 Lead Audior Training
(RABQSA International). St. Louis.
12-13 ASQ Education Course. After
the Audit: Continual Improvement From
the Audit Process. St. Louis.
12-13 ASQ Education Course. Blended
ISO 9001:2000 Lead Auditor Training.
St. Louis.
12-13 ASQ Education Course. Lean
Enterprise. St. Louis. Also offered in
Halifax, Nova Scotia on Nov. 19-20.
66 I OCTOBER 2007 I www.asq.org
12-13 ASQ Education Course. Quality
Audits for Improved Performance.
St. Louis.
12-13 ASQ Education Course. Quality
Cost Principles—Revised. St. Louis.
12-14 ASQ Education Course. Root
Cause Analysis. St. Louis.
12-15 45th Annual Reliability Engi-
neering and Management Institute.
Tucson, AZ. Call the University of Arizona
at 520-621-6120 or e-mail dimitri@u.
arizona.edu
12-16 ASQ Education Course. Black
Belt/Quality Engineering Statistics.
St. Louis.
12-16 ASQ Education Course. Design
for Six Sigma. St. Louis.
12-16 ASQ Education Course. ISO
9001:2000 Lead Auditor Training (RABQSA
International). St. Louis.
12-16 ASQ Education Course. Soft-
ware Quality Engineering. St. Louis.
14 ASQ Education Course. The Case for
Quality: Taking it to Management.
St. Louis.
14 ASQ Education Course. Corrective
Action. St. Louis.
14 ASQ Education Course. Lean Kaizen:
A Simplified Approach to Process Im-
provement. St. Louis.
14 ASQ Education Course. Process
Based Auditing. St. Louis.
14-16 ASQ Education Course. Skills for
Success for the Management Representa-
tive. St. Louis.
15-16 ASQ Education Course. Certified
Quality Auditor Refresher Training.
St. Louis.
15-16 ASQ Education Course. Cus-
tomer-Supplier Partnerships—An Intro-
duction. St. Louis.
15-16 ASQ Education Course. Failure
Modes Effects Analysis—Design and Pro-
cess. St. Louis.
15-16 ASQ Education Course.
Measuring and Managing Customer
Satisfaction and Loyalty. St. Louis.
15-16 ASQ Education Course. Sys-
tematic Problem Solving for Sustained
Improvements With Quality Tools.
St. Louis.
D E C E M B E R
4-5 Human Error Prevention. Dallas. Call
Ben Marguglio at 845-265-0123 or visit
www.hightechnologyseminars.com.
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.
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
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QUALITY PROGRESS I OCTOBER 2007 I 67

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68 I OCTOBER 2007 I www.asq.org

 For information on placing an ad,

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

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QUALITY PROGRESS I OCTOBER 2007 I 69

 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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QUALITY PROGRESS I OCTOBER 2007 I 71

ONE GOOD
IDEA
Process Optimization for Service
Organizations Isn’t Rocket Science
he following is intended for ser-
T vice industry people who are
mostly clueless about quality
improvement. (You manufacturing
people can skip the page because you
already get this, right?)
As a charter member of a group
charged with implementing a quality
management system (QMS) in a tradi-
tional service industry, I have driven
myself to the edge many times trying
to get service managers to understand
process measurement and its relation to
continuous improvement.
After years of meeting resistance on
measurement, making little headway
and not getting through to managers, I
finally came up with a one-page flow-
chart that explains the basics. It ties sup-
pliers, inputs, outputs and customers to
measurement and continuous process
improvement (Figure 1).
The beauty of this flowchart is the
measurement requirements are easily
defined. You have suppliers? Then you
better set standards and measure what
they send you. You have processes?
Then you better set performance goals,
and measure and manage them for
improvement. You have outputs? You
better check if they meet customer
requirements. You have customers?
You need to measure satisfaction to
determine if they are getting what they
FIGURE 1 Process Optimization Flowchart
For the Service Manager
Supplier
Inputs
Measure
inputs. Monitor and
improve the
Critical process.
Measure
business
performance.
process
Measure
Outputs
results. Start
over.
Measure
Customer
satisfaction.
Verify
solution
worked.
72 I OCTOBER 2007 I www.asq.org
by John Scott
want and need. By the way, service people: If you
After all this measuring, the hard
part nobody has time for (too busy
putting those service fires out, you see)
don’t do measurement, you won’t be
able to tell if you fixed a problem or
improved a process.
is what comes next: monitoring the Identify the root cause: Tools used
data to improve the process and prod- are cause and effect diagrams, check-
uct, and keeping the company in busi- sheets, interviews of people involved,
ness. You must analyze the data to see process flowcharts, process maps (easi-
if it’s bad and not meeting standards, er than flowcharts), histograms, scatter
or good and meeting standards. diagrams and the five whys method.
Figure 1 shows that if it’s bad, you Identify data related to the problem
should take corrective action. If it’s and the root cause: This is what you will
good, take preventive action and make look at to see if your solution will actual-
it better. You never know, maybe you ly work. (You’ll test the solution later.)
can avoid some of those raging fires and Although this seems simple, in my
put the firefighters to better use. industry it must be considered near to
There are many process improvement rocket science because it is rarely done.
approaches that can help you figure out You might have data already (see Figure
what to do. The continuous improve- 1), or you have to collect new data.
ment methods include define, measure, Identify the potential solutions:
analyze, improve and control, plan-do- There are many ways to do this,
study-act, Six Sigma and total quality including tree diagrams, process deci-
management. sion charts, matrix diagrams, interrela-
All of them contain one or more of tionship diagrams and common sense.
the following steps: Select the best solution: You must
Identify the problem or improve- make a decision here. All the work you
ment opportunity: Assuming you did just did should give you a clue as to
the measurement part on the flowchart, what the best solution is. Just list the
display and analyze the data using pie possibilities, analyze them and go for
charts, histograms, Pareto charts, run it. There is no way of knowing for sure
charts or control charts. (Control charts whether the solution is going to work.
in the service industry might be too However, based on the work you just
close to rocket science—ignore them if did, there is a great chance it will.
you see the potential for intense pain.) Implement the best solution: Put
the change in place. Plan for it, test it—
if you can—and make the change.
Make sure it worked: It is easy to
implement it and forget it, so you have
to make sure it worked. Is the root
cause of the problem gone? Will the fire
Customer Take need fighting again? Verify the result.
goals/all N corrective
measures action.
Update your QMS and start over: If
Identify
met? problem or you don’t have a QMS, look into it.
Take opportunity. There you have it—a one-page
preventive answer to everything that ails the ser-
Y action.
Document vice industry. (Thanks to all the manu-
root cause. facturing folks who blazed these trails
Analyze work
N for us to follow.)
processes for Identify
further Y
related
improvement. data. JOHN SCOTT is the director of
contract and quality management
for Companion Data Services in
Identify
Opportunity Columbia, SC. He earned his
possible
for improvement solutions. bachelor’s degree in management
Select best science from the University of
solution.
South Carolina-Columbia. He is
Implement an ASQ member and a certified quality manager.
solution.
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