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Putting Best Practices to WorkQu
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www.qualityprogress.com | March 2012
QHow one company took
control using a quality assurance framework p. 16
Email Matters
QUALITY PROGRESSPP
Plus:Web-based Software In Regulated Industries p. 24
Orkin Stomps Out Inefficiency p. 38
Problem solving With Design Thinking p. 32
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Putting Best Practices to Work | March 2012 | www.qualityprogress.com
ContentsFEATURES
• Email Attachments More on the savings one company realized by taming its email in an audio interview with Alec Milton, author of “Email Matters,” p. 16. Also check out an exclusive online sidebar that expands on this month's cover article.
• Orkin Extras Two additional figures to accompany “Eradicating Inefficiency,” p. 38.
• Back to Basics Translated in Spanish.
www.qualityprogress.comOnly @
TECHNOLOGY Email MattersLearn how one company used quality to develop an orderly, structured system that corrals unwieldy emails and makes content more manageable.
by Alec Milton
A Tangled WebInternet-based software is growing in popularity, but FDA-regulated organizations should beware before tapping into this technology.
by Jim Dougherty and Wylene Lengel
PROBLEM SOLVING Rethinking Design Quality professionals should draw from design thinking to enhance problem solving and process improvement efforts.
by Tom Gattiker
CASE STUDY Eradicating InconsistencyA pest management company ridded itself of service problems and customer cancellations by setting up an ISO 9001-certified quality management system and internal audit process.
by Mark Udell and Mike Buffington
16
24
32
38
16
38
QP • www.qualityprogress.com4
Inbox • FMEA and risk.• Shoring up supplier relationships.
Keeping Current • Apple’s supplier struggles.• Students shy away from STEM.
Mr. Pareto Head
QP Calendar
QP Toolbox
QP Reviews
DEPARTMENTS 7
10
12
55
56
58
Up FrontTaming technology.
Innovation ImperativeInnovation first, then technology.
Measure for MeasureFive steps to a first-rate calibration program.
Statistics RoundtableAvoid the right answer to the wrong question.
Standards OutlookThe sometimes rocky road for a regulatory professional.
Career CornerFirst fulfill the basics.
One Good IdeaDeciding on discrete distributions.
Back to BasicsClassifying causes of variation.
Mail Quality Progress/ASQ600 N. Plankinton Ave.Milwaukee, WI 53203Telephone Fax 800-248-1946 414-272-1734414-272-8575
Email Follow protocol of first initial and full last name followed by @asq.org (for example, [email protected]).
Article Submissions Quality Progress is a peer-reviewed publica-tion with 85% of its feature articles written by quality professionals. For information about submitting an article, call Valerie Ellifson at 800-248-1946 x7373, or email [email protected].
Author GuidelinesTo learn more about the manuscript review process, helpful hints before submitting a manuscript and QP’s 2012 editorial planner, click on “Author Guidelines” under “Tools and Resources” at www.qualityprogress.com.
Photocopying Authorization Authorization to photocopy items for internal or personal use or the internal or personal use of specific clients is granted by Quality Progress provided the fee of $1 per copy is paid to ASQ or the Copyright Clear-ance Center, 222 Rosewood Drive, Danvers, MA 01923, 978-750-8400. Copying for other purposes requires the express permission of Quality Progress. For permission, write Quality Progress, PO Box 3005, Milwaukee, WI 53201-3005, call 414-272-8575 x7406, fax 414-272-1734 or email [email protected].
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Membership and Subscriptions For more than 60 years, ASQ has been the worldwide provider of information and learn-ing opportunities related to quality. In addi-tion, ASQ membership offers information, networking, certification and educational opportunities to help quality profession-als obtain practical solutions to the many problems they face each day. Subscriptions to Quality Progress are one of the many benefits of ASQ membership. To join, call 800-248-1946 or see information and an application on p. 31.
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QUALITY PROGRESS
Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203. Editorial and advertising offices: 414-272-8575. Periodicals postage paid at Milwaukee, WI, and at additional mailing offices. Institutional subscriptions are held in the name of a company, corporation, government agency or library. Requests for back issues must be prepaid and are based on availability: ASQ members $15 per copy; nonmembers $23 per copy. Canadian GST #128717618, Canadian Publications Mail Agreement #40030175. Canada Post: Return undeliverables to 2835 Kew Drive, Windsor, ON N8T 3B7. Prices are subject to change without prior notification. © 2012 by ASQ. No claim for missing issues will be accepted after three months following the month of publication of the issue for domestic addresses and six months for Canadian and international addresses.Postmaster: Please send address changes to the American Society for Quality, PO Box 3005, Milwaukee, WI 53201-3005. Printed in USA.
ASQ’s Vision: By making quality a global priority, an organizational imperative and a personal ethic, the American Society for Quality becomes the community for everyone who seeks quality technology, concepts or tools to improve themselves and their world.
- SECOND SET OF SEVENThe new management and planning tools.
- WINNING STRATEGY? A closer look at Moneyball analytics.
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This report from the American Productivity and Quality Center explores ways to fi nd knowledge and expertise through Web 2.0 tools such as wikis, blogs, social networking, and social tagging. Included are in-depth case studies from best-practice organizations.
Access this month’s featured content and more Web-exclusives in the ASQ Knowledge Center at asq.org/knowledge-center/featured.html.
upfront
E rulesHarnessing technology’s efficiencies
We think of technology as the backbone for creating efficiencies, for doing our jobs bet-
ter and for making information sharing near-immediate. To this day, it amazes me that I can
snap a photo of my daughter and instantly share it with friends and family spread out across
the country. That’s just one minor (but life-altering) example of the power of technology.
Yet, for all its benefits, technology is not a panacea. It’s actually a little surprising more
computers aren’t hurled out office windows when systems crash, programs lock up or you
can’t remember one of the 27 different username/password combinations you have for 85
different programs and websites.
This month, we feature a lineup of articles geared toward improving efficiency and un-
derstanding the impact—and limitations—of technology in your organization.
Emails fall into the 80% of what’s considered “unstructured” company data, explains the
author of this month’s cover story, “Email Matters,” p. 16. Citing its unwieldiness—and the
fact it exposes companies to risk—the author goes on to describe a tool one company used
to get email systems under control.
Managers spend up to two hours per day searching for information, he writes, citing a
study from Accenture; that’s pure waste! The author describes how Arup, a consulting firm,
designed an email management software plug-in to address compliance, improve productiv-
ity, eliminate costly project errors and reduce IT storage costs. The lesson? Take a quality
assurance approach when it comes to technology.
Technological advancements in the form of software as a service applications (SaaS) are
growing in popularity for many obvious reasons, yet this technology poses a particular set
of challenges to FDA-regulated industries. In the article “A Tangled Web,” p. 24, the authors
detail how important it is to have a handle on these vendors to ensure security, proper
backup and communication, among other reasons.
“Pre-selection and ongoing audits are of greater significance to SaaS suppliers than con-
ventional software vendors because greater reliance is placed on a SaaS supplier’s quality
systems,” the authors write.
And don’t miss this month’s “Innovation Imperative” column, in which Peter Merrill
discusses the capricious relationship between technology and innovation. He gives his opin-
ions on which is the cart between the two, and which is the horse. QP
Seiche Sanders
Editor
PublisherWilliam A. tony
executive editor andassociate PublisherSeiche Sanders
associate editorMark Edmund
assistant editorBrett Krzykowski
manuscriPt coordinatorValerie Ellifson
contributinG editorAmanda Hankel
coPY editorSusan E. Daniels
art directorMary uttech
GraPhic desiGnerSandy Wyss
Production Cathy Milquet
advertisinG ProductionBarbara Mitrovic
diGital Production sPecialistLaura franceschi
media salesnaylor LLCLou BrandowKrys D’Antonionorbert Musialrob Shafer
media sales administratorKathy thomas
marketinG administratorMatt Meinholz
editorial officesphone: 414-272-8575fax: 414-272-1734
advertisinG officesphone: 866-277-5666
asQ administrationceo paul E. Borawski
managing directorsChristopher D. BaumanJulie GabelmannBrian J. LeHouillierMichelle MasonLaurel nelson-rowe
to promote discussion of issues in the field of quality and ensure coverage of all responsible points of view, Quality Progress publishes articles representing conflicting and minor-ity 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 product or service by ASQ.
QualitY ProGress
QP
QP • www.qualityprogress.com6
Use with cautionAs a member of the committee
that developed the medical de-
vice risk management standard
ISO 14971 and an adjunct fac-
ulty member at Virginia Tech’s
Health Products Risk Manage-
ment Graduate Program, I find
I often need to caution those
using failure mode and effects
analysis (FMEA) to remember it was de-
signed as a reliability tool.
FMEA is not risk analysis, but it is a good
tool to use after the product is designed to
determine whether all of the hazards in the
fault condition are identified as required in
ISO 14971. Pharmaceutical guidance ICH
Q9, which was derived from ISO 14971,
also uses FMEA to aid in risk management.
It is important to identify the definition of
risk as it is used in a variety of contexts. In
ISO 14971 and ICH Q9, direction is provided
for product safety, but it is not intended to
address business, compliance or other types
of risk. ISO 31000 provides definitions and
direction for those types, as well as others.
Because FMEA identifies the hazard
and its effect, it operates on a different
level than risk analysis, which analyzes
the severity of harm and the probability
of the harm’s occurrence. This provides a
different result than FMEA. ISO 14971 also
requires identifying all of the normal condi-
tion hazards, which FMEA does not. Normal
condition hazards are usually identified in
the usability engineering activities.
Regulators require the identification
of safety requirements using risk analysis
early in the design process, during design
input. Because FMEA requires
some design to be complete,
it is not typical to have inputs
from this tool at the design
input stage. As inputs are
revised later, the inputs from
FMEA can be applied.
If an effective risk analysis
is performed at the beginning
of product design, many of the
risks can be identified and input into the
design stage, reducing the impact of costly
late-stage design changes. While FMEA is
a valuable tool when used properly, it can
reduce the effectiveness of risk manage-
ment when used improperly.
“Fail-Safe FMEA” (January 2012, pp. 30-
36) provides good information on the use
of FMEA, but the warnings I have provided
may guide the reader toward using the tool
for effective product risk management.
Edwin Bills
Sumter, SC
Mutual benefit“Lead On” (January 2012, pp. 37-41) is truly
insightful and reinforces the type of cultural
change we are trying to instill at our com-
pany: a greater concern for our customer
and a clear understanding of our customer-
supplier interfaces.
By creating empathy with suppliers and
understanding their needs and expectations,
we will open the door to improved customer
service while helping suppliers perform at
optimal capacity and at the same time cre-
ating a mutual, trust-based relationship.
Cynthia Van-Dunem
Luanda, Angola
INBOx QPQUALITY PROGRESS
In Your own wordsLet us know what you think about the topics in this month’s feature articles or anything else on your mind by emailing [email protected].
PAST CHAIRE. David Spong, The Boeing Co. (retired)
CHAIRJames J. Rooney, ABS Consulting
CHAIR-ELECTJohn C. Timmerman, Marriott International Inc.
TREASURERWilliam B. (Bo) McBee, Hewlett-Packard Co. (retired)
PARLIAMENTARIANKarla Riesinger, ASQ
DIRECTORSJ. Michael (Mike) Adams, Allegheny Energy Inc. (retired)Belinda Chavez, United Space AllianceDarlene Stoddard Deane, Automotive Components
Holding LLCHerbert Goldstein, Ortho-Clinical Diagnostics (retired) Alexis P. Goncalves, Pfizer Inc.Kathleen Jennison Goonan, Goonan Performance
StrategiesRichard A. Gould, RG Management SolutionsHarold P. Greenberg, American Certification Corp.Marc P. Kelemen, NanoSynopsis LLCLou Ann Lathrop, Chrysler LLCJoanne D. MayoElias Monreal, Industrial Tool Die & EngineeringRichard A. Perlman, Bayer HealthCareArt Trepanier, Lockheed MartinJ. Eric Whichard, JE Whichard & AssociatesSteven E. Wilson, U.S. Department of Commerce
Seafood Inspection Program
QP EDITORIAL REVIEW BOARDRandy Brull, chair
Administrative Committee Brady Boggs, Randy Brull, Jane Campanizzi, Larry Haugh, Jim Jaquess, Gary MacLean,R. Dan Reid, Christine Robinson, Richard Stump
Technical reviewersI. 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 J. Rooney, Anil Sengupta, Sunil Thawani, Joe Tunner, Jeffrey Vaks, Manu Vora, Jack Westfall, James Zurn
March 2012 • QP 7
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QP • www.qualityprogress.com10
In January, the world may have received the most convincing evi-
dence yet of how difficult—and perhaps impossible—it is to know
everything that occurs in a supply chain that spans the globe.
The lesson came courtesy of consumer electronics giant Apple
Inc., which, in a span of two weeks, saw its reputation swing from
an organization that carefully oversees its suppliers to one that
struggles to keep its partners in line.
The socially responsible side of that duality stepped to the fore
Jan. 13, when for the first time ever the notoriously clandestine com-
pany pulled back the curtain on its list of global suppliers. The move
would have been unlikely at best under former CEO Steve Jobs but
was viewed by many as a signal that new leader Tim Cook would be
operating in a spirit of greater transparency.
According to the report, Apple increased its number of supplier
audits conducted by 80% from the previous year for a total of 229 in
2011, including more than 100 at factories it had not visited before.1
“With every year, we expand our program, we go deeper in our
supply chain, we make it harder to comply,” Cook told Reuters News
Agency. “All of this means that workers will be treated better and
better with each passing year. It’s not something (where) we feel like
we have done what we can do; much remains to be done.”2
Less than two weeks later, an article in
the New York Times revealed that Cook
wasn’t kidding. The article detailed
worker safety shortcomings at sev-
eral suppliers, including one of the
biggest cogs in the chain, Foxconn
Technology.
The report described safety issues
at Foxconn’s plant in Chengdu, China,
including workers exceeding Apple’s
mandated work limit of 60 hours per week
and company dorms with as many as 20 people in a three-bedroom
unit.3 But the centerpiece of the report was an explosion last May
that killed four and injured another 18 at the iPad plant in Chengdu.
Highly combustible aluminum dust fueled the blast, after which
Apple said it immediately contacted “the foremost experts in pro-
cess safety” and created a plan to prevent future incidents.4 Seven
months later, however, another explosion injured 59 workers at an
iPad plant in Shanghai.
In its supplier report, Apple said the causes of the blasts were
different, as were many of the corrective actions demanded by the
company, which included ventilation requirements, ductwork inspec-
tions and the use of vacuums “rated explosive proof to prevent
ignition.” At the time the report was released, Apple said all suppliers
but one had the new measures in place and that the outlier would
remain shut down until it complied.5
The report shines a light on nearly every facet of Apple’s supply
chain and provides statistics for compliance with safety measures—
from prevention of underage labor (97% compliance) to working
hours (38%). It also outlines Apple’s response in the form of correc-
tive actions it requires to improve the situation.6
But according to the Times article, that watchful eye hasn’t been
enough to deter suppliers from doing whatever it takes to deliver
the cost-effective solutions Apple demands. “We’re trying really hard
to make things better,” one former Apple executive told the Times
while requesting anonymity because of confidentiality agreements.
“But most people would still be really disturbed if they saw where
their iPhone comes from.”7
That uphill battle hasn’t deterred Apple from becoming the first
technology company to join the Fair Labor Association (FLA). The
group will compare the performance of Apple’s suppliers with the
FLA’s “Workplace Code of Conduct” and post the results on www.
fairlabor.org, adding another level of transparency to the Apple sup-
ply chain.8
“We care about every worker in our worldwide supply chain,”
Cook wrote in a letter to his employees shortly after the Times ar-
ticle was published. “Any accident is deeply troubling, and any issue
with working conditions is cause for concern. Any suggestion that
we don’t care is patently false and offensive to us. As you know bet-
ter than anyone, accusations like these are contrary to our values.
It’s not who we are.”9
—Brett Krzykowski, assistant editor
REFERENCES1. Apple Inc., “Apple Supplier Responsibility: 2012 Progress Report,” http://images.apple.com/
supplierresponsibility/pdf/Apple_SR_2012_Progress_Report.pdf (case sensitive).2. Poornima Gupta, “Apple Reveals Supply Chain, Details Conditions,” Jan. 13, 2012, www.reuters.
com/article/2012/01/13/us-apple-suppliers-idustre80c1kq20120113.3. Charles Duhigg and David Barboza, “In China, Human Costs Are Built Into an iPad,” New York
Times, Jan. 25, 2012, www.nytimes.com/2012/01/26/business/ieconomy-apples-ipad-and-the-human-costs-for-workers-in-china.html?_r=1.
4. Apple Inc., “Apple Supplier Responsibility: 2012 Progress Report,” see reference 1.5. Ibid.6. Ibid.7. Duhigg, “In China, Human Costs Are Built Into an iPad,” see reference 3.8. Apple Inc., “Apple Supplier Responsibility: 2012 Progress Report,” see reference 1.9. Anand Krishnamoorthy, “Apple’s Cook Won’t Turn ‘Blind Eye’ to Problems With Suppliers’
Conditions,” Bloomberg, Jan. 27, 2012, www.bloomberg.com/news/2012-01-27/apple-won-t-turn-blind-eye-to-supply-chain-problems-cook-says.html.
kEEPINgCuRRE NT SuPPLy CHAIN MANAgEMENT
Bruised, Not BeatenApple’s supplier issues reveal challenges of global partnerships
March 2012 • QP 11
kEEPINgCuRRE NTQWho’s Who in
NAME: James L. Bossert
RESIDENCE: Fort Worth, TX
EDUCATION: Doctorate in technology management specializing in qual-
ity systems from Indiana State university in Terre Haute.
CURRENT JOB: Process design manager in the pro-
cess optimization group of the legacy asset services
organization at Bank of America.
INTRODUCTION TO QUALITY: Bossert built model
cars when he was growing up. The hobby shop
where he purchased the models had competitions
in which those who built the best-looking models
won gift certificates. The hobby forced Bossert to pay close attention to
detail, use different tools and techniques, look for ways to make every-
thing fit together and build the best possible item.
PREVIOUS QUALITY EXPERIENCE: Americas region vice president for
quality at Nokia in the late 1990s.
ASQ ACTIVITIES: Bossert has been an active member for more than 30
years. He currently is on Six Sigma Forum Magazine’s editorial review
board and participates in the Ask a Standards Expert program. Bossert
is a member of ISO/technical committee 69, which deals with standard-
ization in the application of statistical methods. He contributes to the
development of the Six Sigma Master Black Belt exam.
OTHER ACTIVITIES: He was the first member of the John D. Hromi Cen-
ter for Quality and Applied Statistics Academy at Rochester Institute of
Technology in Ny. He has also served as a Baldrige examiner.
PUBLISHED WORKS: Editor for the Supplier Management Handbook for
the past 20 years. Co-author of Supplier Certification, and the glossary
and tables in Statistical Quality Control. Contributor to Six Sigma Forum
Magazine and QP.
RECENT HONORS: ASQ’s Distinguished Service Medal, which he will re-
ceive at this year’s ASQ World Conference on Quality and Improvement.
PERSONAL: Wife, Terri, two daughters, two stepsons and five grandchil-
dren.
OTHER ACTIVITIES: Playing the guitar, spending time with his grandchil-
dren, reading, golfing and brewing beer.
QUALITY QUOTE: Take a chance and try something new. your learning
will make you a more knowledgeable and interesting person.
Teenagers seem to like the idea of having a career in sci-
ence, technology, engineering and math (STEM), but many
worry about obstacles that might block their pursuit of pro-
fessions in those areas, according to a recent ASQ-Harris
Interactive survey.
Sixty-seven percent of sixth through 12th-graders who
said in the survey they were interested in pursuing a STEM
career also expressed concern about factors that might
hold them back from doing so, which include perceptions
such as:
• The cost and time to get a degree in STEM seems too
high compared with other subjects (26%).
• Their grades in STEM subjects aren’t good enough
(25%).
• STEM-degree careers involve too much work and study
compared with other careers (25%).
“It’s encour-
aging to see that
more students
see the value of
STEM careers
like engineering,
but clearly STEM professionals and educators can be doing
more to support students along this career path,” said Jim
Rooney, ASQ chair and quality engineer with ABS Consult-
ing in knoxville, TN.
The survey included responses from 713 youths. A
complementary survey of 327 parents of children aged 10
to 17 also was conducted. More than half of the parents
who had children interested in STEM careers said they had
concerns about their children pursuing a STEM-related
career.
Twenty-six percent of parents said they believed their
child was not being prepared enough in STEM subjects by
teachers, and 18% said they worried about their child’s
grades not being good enough in STEM subjects.
For more details on the survey, visit www.asq.org/
media-room/index.html.
ENgINEERINg
SURVEY: STUDENTS WORRY ABOUT BARRIERS TO ENgINEERINg PROfESSION
67% of youth are reluctant to pursue STEM careers.
“ ”
QP • www.qualityprogress.com12
kEEPINgCuRRENT
QPONLINE ONPAPER
QuiCk Poll RESulTS Each month at www.qualityprogress.com, visitors
can take an informal survey. Here are the num-
bers from a recent Quick Poll:
“What type of customer survey do you find
most annoying?”
• Phone 42.8%
• Website pop-up 37.6%
• In person 12.9%
• Email 5.1%
• Snail mail 1.2%
Visit www.qualityprogress.com for the latest
question:
“How would you describe your email use?”
• Can’t keep up with my overloaded inbox.
• keeping up, but it takes too much time.
• Totally in control.
MoRE iNSiGHT oN iNBoXESThis month, listen to an interview with Alec Milton,
author of “Email Matters,” pp. 16-23, discussing
how an organization incorporated quality assur-
ance principles to better manage email content.
Only one in seven errors, accidents and other events that harm Medicare pa-
tients in hospitals are recognized and reported by hospital employees, federal
investigators wrote in a recent report.
Even after hospitals investigate preventable injuries and infections that
have been reported, hospitals rarely change their practices to prevent ad-
verse events from recurring, according to the study.
Adverse events include medication errors, severe bedsores, infections that
patients acquire in hospitals, delirium resulting from overuse of painkillers
and excessive bleeding linked to improper use of blood thinners.
The study was issued by Daniel R. Levinson, inspector general of the u.S.
Department of Health and Human Services.
SouRCERobert Pear, “Report Finds Most Errors at Hospitals Go Unreported,” New York Times, Jan. 6, 2012, www.
nytimes.com/2012/01/06/health/study-of-medicare-patients-finds-most-hospital-errors-unreported.html?_r=2&ref=health.
Mr. Pareto Head By MIKE CRoSSEn
HEALTHCARE
fEDERAL STUDY: MOST ERRORS AT HOSPITALS gO UNREPORTED
More than 40% of new-vehicle buyers who avoid a particular model because of
quality or reliability concerns said their opinions were based on conventional
wisdom or common knowledge rather than personal experience, reviews, rat-
ings or recommendations, according to a recent J.D. Power and Associates study.
Among buyers who avoid a particular model due to concerns about quality
and reliability, the study determined that a sizable proportion—43%—said their
avoidance was because “the brand’s vehicles, in general, are known to have
poor quality/reliability.”
For more details on the study, visit http://businesscenter.jdpower.com/
news/pressrelease.aspx?id=2012003.
AuTOMOTIVE
PRECONCEPTIONS KEEPSOME CAR BUYERS AWAY
March 2012 • QP 13
kEEPINgCuRRENTASQ
WORLD CONfERENCE KEYNOTE SPEAKERS ANNOUNCEDExecutives from two high-profile Fortune 100 companies are among
the keynote speakers who will address audiences at ASQ’s World Con-
ference on Quality and Improvement (WCQI) May 21-23 in Anaheim, CA.
James Albaugh is executive vice president of
the Boeing Co. and president and CEO of Boe-
ing Commercial Airplanes. A member of Boeing’s
executive council, Albaugh is responsible for the
company’s commercial airplanes programs and
services, and is Boeing’s senior executive in the
Pacific Northwest. He is scheduled to speak at
7:45 a.m. Monday, May 21.
Carletta Ooton is vice president and chief
quality, safety and sustainable operations officer
for the Coca-Cola Co. Ooton oversees policies and
standards, audits, analytical services, food safety,
customer quality, performance measures and
operations support delivered by Coca-Cola’s global
quality organization. She is scheduled to speak at
12:15 p.m. Monday, May 21.
Other keynote speakers scheduled to appear at
the three-day conference are:
Simon Sinek, leadership expert and author of
Start With Why: How Great Leaders Inspire Everyone
to Take Action. Sinek’s presentation is slated for 8
a.m. Tuesday, May 22.
Majora Carter, president of MCg Consulting,
a firm that advises organizations about climate
adaptation, urban micro-agribusiness and leader-
ship development strategies. She also hosts “The
Promised Land,” a public radio series that show-
cases leaders and visionaries making a difference in
their communities. Carter is scheduled to appear at
10:45 a.m. Wednesday, May 23.
Joseph A. Defeo, president and CEO of the Ju-
ran Institute, and a leading authority on transforma-
tional change systems and breakthrough manage-
ment principles. He will be the featured speaker at
1:15 p.m. Tuesday, May 22.
Visit http://wcqi.asq.org/index.html for more
about the speakers, the 100-plus conference ses-
sions and a complete schedule of events and details. There’s also
information on the other miniconferences sponsored by different
ASQ divisions that will take place concurrently with WCQI, including
the Quality Institute of Healthcare Conference, the Institute for Soft-
ware Excellence, the Institute for Continual Quality Improvement
and Quality in Sustainability.
ASQ
SIX NEW ASQ OffICERS NOMINATED TO BOARDASQ’s Board of Directors will vote on six board
candidates named by ASQ’s nominating commit-
tee earlier this year. The nominated officers are:
• Chair: John C. Timmerman, vice president of
global guest experience and rooms operations,
Marriott International Inc., Bethesda, MD.
• Past chair: James J. Rooney, director of quality
management and lean Six Sigma services, ABS
Consulting, knoxville, TN.
• Chair-elect: Stephen k. Hacker, CEO and co-
founder, Transformation Systems International,
Portland, OR.
• Treasurer: Chava Scher, vice president of qual-
ity, Rafael Advanced Defense Systems, Haifa,
Israel.
• Director: Alejandra Vicenttin, director of hotel
operations, L’auberge Casino Resort, Baton
Rouge, LA.
• Director: Bharat Wakhlu, resident director for
public affairs, Tata Services Ltd., New Delhi,
India.
Election results are scheduled to be announced
during ASQ’s annual business meeting, which will
be held at the World Conference on Quality and
Improvement from May 21-23 in Anaheim, CA.
ALBAUgH
OOTON
SINEK
CARTER
DEfEO
use your smartphone
and a free QR app
to scan this code
and visit the WCQI
website. Closer to the
conference, a mobile-
friendly site will
allow attendees to
browse sessions and
other details.
QP • www.qualityprogress.com14
kEEPINgCuRRENTaSQNEWSFElloW HoNoRED Manu k. Vora, an
ASQ fellow who has served on the ASQ
Board of Directors, has been awarded
the IIT Alumni Medal from the Illinois
Institute of Technology in Chicago.
An awards ceremony on the school’s
campus is scheduled in April.
OTT APPLICATIONS Applications for
the 2012-2013 Ellis R. Ott Scholarship
are now available through ASQ’s Statis-
tics Division. The $7,500 scholarships
are for students in master’s degree or
higher programs with a concentration
in applied statistics or quality manage-
ment. Last year’s recipients were Shilpa
Shinde from Arizona State university,
Wade Henning from Florida State
university and kristopher Hoover from
North Carolina State university. For
more information and an application
form, visit www.asqstatdiv.org. Applica-
tions are due April 1. Direct questions
about the scholarship to Lynne B. Hare
fREUND SCHOLARSHIP Applications
for the Richard A. Freund Interna-
tional Scholarship are due April 1. This
scholarship recognizes graduate study
in the theory and application of qual-
ity control, quality assurance, quality
information and total quality manage-
ment. The approximate amount of the
yearly award is $5,000. Last year’s
recipient was David Zepeda, a Juran
fellow who is pursuing a doctorate in
operations and management science at
the Carlson School of Management at
the university of Minnesota. For more
information and an application form,
visit http://asq.org/about-asq/awards/
freundscholar.html.
SHORTRUNSTHE JURAN INSTITUTE has acquired
Baldrige.com, an online community for
Baldrige supporters and others inter-
ested in learning about the Baldrige
Performance Excellence Program. For
more information, visit www.baldrige.
com/sector/business/juran-institute-
acquires-baldrige-com-2.
NATIONAL HEALTHCARE QUALITY
WEEK is slated for Oct. 14-20 to high-
light the need to influence professionals
to improve patient care outcomes and
healthcare delivery systems. The event
is sponsored by the National Association
for Healthcare Quality. For more informa-
tion, visit www.nahq.org/membership/
content/celebratehealthweek.html.
THE COMMITTEE Of SPONSORINg
Organizations of the Treadway Commis-
sion, commonly referred to as COSO, has
released for public comment an updated
“Internal Control—Integrated Frame-
work” intended to help organizations
improve performance with greater agil-
ity, confidence and clarity. The revised
framework contains quality manage-
ment inputs, such as requirements that
objectives be measurable and organiza-
tions exhibit a commitment to compe-
tence. To access the complete frame-
work and submit comments, visit www.
ic.coso.org. Comments are due March
31. For more information, contact Sandy
Liebesman at [email protected].
THE BRITISH STANDARDS Institution
has revised publicly available specifi-
cation (PAS) 2050. PAS 2050 provides
a method for assessing the life cycle
greenhouse gas emissions of goods and
services, the standard used to calculate
the carbon footprint of an organization’s
goods and services. For more informa-
tion, visit www.bsigroup.com/pas2050.
THE AMERICAN SOCIETY for Non-
destructive Testing (ASNT) is seeking
applicants for its certification manage-
ment council. The council is responsible
for developing and managing ASNT’s
certification programs. For more infor-
mation, visit www.asnt.org/latestnews/
cmcappl09.htm.
Certifications for management system
standards for quality, environment, medi-
cal devices, food safety and information
security from the International Organiza-
tion for Standardization (ISO) increased
6.23% in 2010, according to a recent ISO
survey.
The largest certification increas-
es occurred in sector-specific ISO
22000:2005—Food safety management
systems, which jumped 34%, and issue-
specific ISO/International Electrotechnical
Commission 27001:2005—Information
security management systems, which
increased 21%.
“Indicating nearly a million and a half
users at the end of 2010, these figures il-
lustrate the continuing attraction of the ISO
management system model pioneered by
ISO 9001 for quality management and since
extended to meet other challenges faced
by public and private sector organizations,”
said Rob Steele, ISO secretary-general.
For more information, visit www.iso.
org/iso/pressrelease.htm?refid=Ref1491
(case sensitive).
STANDARDS
ISO CERTIfICATIONS ON THE RISE
March 2012 • QP 15
kEEPINgCuRRENT
Months after federal funding to the Baldrige Performance Excel-
lence Program was eliminated, a new study was released that touts
the significant benefits the program has for individual organizations
as well as the entire u.S. economy.
The National Institute of Standards and Technology’s (NIST)
economic study shows the benefit-to-cost ratio of Baldrige Award
applicants was 820:1. NIST says this and other study results “sup-
port the belief that the Baldrige program creates great value for the
u.S. economy.”
The latest study follows up on a 2001 analysis of potential
benefits versus costs of the Baldrige program. Ten years ago, the
authors—economists Albert N. Link and John T. Scott—estimated
the total potential economic benefits of the Baldrige program to
the u.S. economy at nearly $25 billion and its total operational cost
at $119 million, or a 207-to-1 cost-to-benefit ratio. Last year, the
authors estimated the benefits outweigh the overall cost of the
program by a ratio of 820-to-1.
“The Baldrige Performance Excellence Program, with the
imprimatur of national leadership and a prominent national award
presented by the president, creates great value that could not be
replicated by private-sector actions alone,” the authors wrote.
Last year, Congress and President Obama approved a bill that
eliminated $9.6 million in federal funding to the program for 2012.
The Baldrige Foundation, a private, nonprofit organization that sup-
ports the program, agreed to maintain the program’s operations
through this year.
The program had already started making contingency plans and
has begun looking at business and funding models to keep the
Baldrige program sustainable without federal funding for the long
term.
The latest study surveyed 273 award applicants since 2006.
From the results of the 45 organizations that responded, the econo-
mists used a counterfactual evaluation method to measure three
categories of social benefits to come up with a net social value of
the program. The categories were:
• Savings to the applicants in investment costs to achieve the
same level of benefits from their performance excellence strate-
gies as they realized from the Baldrige program.
• gains by consumers in greater satisfaction from higher quality
products and services.
• gains to the economy from saving scarce resources through use
of the Baldrige criteria.
Benefit-to-cost ratios were calculated using alternative mea-
sures of benefits, and each category was separately compared to
the entire operating cost of the program. The 820-to-1 benefit-to-
cost ratio uses only the benefits for the survey group of applicants
for the award since 2006, but uses all the social costs of the
program.
To download a PDF version of the report, visit www.nist.gov/
director/planning/upload/report11-2.pdf.
SouRCESGeorge, Steve, “Benefit-to-Cost Ratio for Baldrige: 820-to-1,” Baldrige.com, Jan. 19, 2012, www.
baldrige.com/tag/baldrige-award.Link, Albert n., and John T. Scott, “Planning Report11-2: Economic Evaluation of the Baldrige
Performance Excellence Program,” national Institute of Standards and Technology, Dec. 16, 2011.
nIST Tech Beat, “Economic Study Shows Value of Baldrige-Based Performance Excellence,” Jan. 18, 2012, www.nist.gov/baldrige/baldrige-011812.cfm.
BALDRIgE PROgRAM
STUDY: BALDRIgE BENEfITS fAR OUTWEIgH THE COSTS
BYTHENUMBERSThe number of world-class winners of the global Perfor-
mance Excellence Awards from the Asia Pacific Quality
Organization (APQO). They are:
• goodbaby International Holdings Ltd., Jiangsu Province, China.
• Singapore Technologies Engineering Ltd., StarHub Centre, Singapore.
• Shanghai No.7 Construction Co. Ltd., Shanghai.
• global Indian International School Singapore, Queenstown Campus, Singapore.
• PuB, Singapore National Water Agency, Singapore.
• Housing and Development Board, Singapore.
Twelve other organizations received Best in Class Awards and Quest for Ex-
cellence Awards from APQO at a ceremony in Singapore. For more information
about the honorees, visit www.apqo.org or www.begcapqc.com.
WORDTOTHEWISETo educate newcomers and refresh practi-
tioners and professionals, QP occasionally
features a quality term and definition:
Consumer’s riskPertains to sampling and the potential risk that
bad products will be accepted and shipped to
the consumer.
SouRCE “Quality Glossary,” Quality Progress, June 2007, p. 43.
6
Email Matters
How one company tamed email and turned it into a time-saving, cost-cutting project management tool
by Alec Milton
In 50 Words Or Less • Manyorganizationsface
timeandcostinefficien-cies,aswellashigherrisk,duetopooremailman-agement.
• Oneglobalfirmdevelopedsoftwareusingaqualityassuranceframeworktomeetthedemandsofitsemailusers.
• Thefirm’ssoftwaredevel-opmentprocessprovidesinsightforotherorganiza-tionswishingtoimproveemailmanagement.
technology
IN A RECENT survey of 1,237 email management product users across a
variety of disciplines, 96.5% of respondents said they believed their companies
should place medium to high priority on the quality assurance (QA) of email.
One in five said they believed their company faces high risk due to poor email
management.1
It is commonly accepted that 80% of data within an organization is unstruc-
tured and that most companies are working with only the 20% of structured,
easily accessible data. Unstructured data refers to content that does not lend
itself to standard storage and retrieval methods. Emails are considered a part of
the definition of unstructured data. But with the right processes, it is possible to
get email under control.
March2012•QP 17
QP•www.qualityprogress.com18
Better management neededIn the architecture, engineering and construction
(AEC) industries, the likelihood of needing to produce
all-electronic correspondence regarding a project for
litigation purposes is higher than in most other indus-
tries. Some companies store the content of email mes-
sages for this simple purpose. But this can still leave
an organization exposed, as was the case in Williams
v. Sprint, when the court ruled electronic data must be
produced in native format.2
Additionally, AEC projects involve participants
from multiple locations and companies on and off site,
and communication must be transparent to keep the
workflow of a project on track.
With the expansion of globalization comes an in-
crease in technology-based communication that will
only continue to grow. If organizations do not address
how to create solutions for email management, there
will continue to be staggering losses of pertinent infor-
mation, costly errors and even more costly fines when
confronted with a court-ordered retrieval process.
Even the mighty Microsoft was not immune. It was
ordered to pay $25 million when certain email evidence
had not been produced during e-discovery.3
Tony Broomhead of BL Consult, a firm that handles
dispute avoidance in construction, summed it up aptly
when he said, “The ability to instantly put your hand
on any email not only saves a tremendous amount
of time in day-to-day operations, it also protects you
from unfounded litigation. In the construction busi-
ness, capturing communication is critical to the suc-
cess of a project and is absolutely necessary in order
to have full records available for the inevitable dis-
putes that occur in this industry. Too many businesses
fail to realize the need for good email filing until it is
too late.”4
That is why software developers at Arup, a global
firm of consulting engineers with more than 10,000
staff members in 33 countries, decided it was time to
proactively create a solution for turning unstructured
email data into structured, accessible information.
The resulting multifaceted email management soft-
ware plug-in exceeded expectations by transforming
compliance assurance, increasing productivity, elimi-
nating costly project errors and reducing IT storage
costs. The lessons learned in the process of developing
the product were as important as the final product itself,
which is now used in multiple industries worldwide.
Pay laterAn Accenture survey reported that managers spend up
to two hours each day searching for information. In
addition, 45% of the managers surveyed for the report
stated that gathering information about the activities
of other parts of their company is a big challenge due,
in part, to the way information is gathered and stored.
The majority of managers said they store their most
valuable information on their computer or in their indi-
vidual email accounts, with only 16% using a collabora-
tive option.5
If the information is required to support a legal pro-
ceeding, the pressure is high and costs can rise dramat-
ically if a complete set of electronic documents must
be found under a court-ordered deadline. The Interna-
tional Data Corp. estimated the cost to U.S. business
to identify, preserve, collect, process, review, analyze
and produce information for litigation (e-disclosure) to
be $12 billion, reaching as high as $22 billion in 2011.6
Gartner Inc., an IT research and advisory compa-
ny, estimated the average e-disclosure event, includ-
ing regulatory investigations and lawsuits, costs $1.5
million for an average U.S. company with $1 billion
revenue. Those same companies can face more than
500 lawsuits at any given time. The main factor driv-
ing these costs is the amount of data that must be col-
lected, reviewed, analyzed and produced.7
Yet few organizations take steps to structure their
email data for easy retrieval. For an organization to
solve this problem, it needs to get email under QA con-
trol in a way that doesn’t hinder the fluid nature of the
medium or place costly demands on IT departments.
Five solutions to the same problemIn 2002, Arup had well-defined QA procedures for pa-
per documents, but fragmented methods for email.
Arup had been developing commercial software for
the AEC markets for many years, however, and thus
had the capability to address the problem through soft-
ware.
Arup realized it needed a QA-compliant way to man-
age email correspondence with the same care as paper
documents. The problem was not which tool to buy,
but rather how to tame the process of unifying the five
internally developed tools into one globally adopted
tool.
There was an opportunity to unify project corre-
spondence and improve team communication, while at
March2012•QP 19
the same time addressing existing concerns about the
speed of data retrieval and the limited storage capacity
of the email systems.
Arup’s London office had started to develop an
email management tool to gain QA control of business
email. Quickly, it heard that other parts of the firm
were trying to solve the same problem. An internal in-
vestigation revealed five offices (Moscow, Sydney, and
London, Newcastle and Bristol in England) were all
developing their own solutions.
Each developer had a vested interest in its own tool,
which was typically targeted at regional or national
needs. The initial QA challenge was to get everyone to
agree on one solution that would meet the needs for
the whole business.
The key players first met by phone and screen shar-
ing to discuss and evaluate the different approaches to
a solution. A show-and-tell session allowed each prod-
uct to be reviewed. The decision was quickly made to
proceed with the London development as a base model
and integrate some of the ideas from the other prod-
ucts. To provide continuity, the other tools remained
in use until the London tool reached the required level
of maturity.
The following basic criteria were agreed on:
• BuildtheinterfaceintoMicrosoftOutlooktomake
it accessible to users.
• Enablemessagestobestoredinthesamelocation
as other project documents to streamline team col-
laboration and project management communica-
tion.
• Havetheabilitytosearchformessagesbasedonthe
project they relate to and their contents.
Because QA drove the tool, Arup set up an interna-
tional client committee of mostly QA professionals to
handle the process. One concern that quickly surfaced
from the committee was that no one wanted to put his
or her data into a system that might not be around in
the distant future. At this point, the project could have
failed because all software has a limited lifecycle. In-
stead, it gave birth to a new approach.
Rather than create a database with the contents
of the messages, which was a common and popular
approach, it was agreed to store the emails in na-
tive Microsoft message (MSG) format and in regular
file system folders. If the software was later super-
seded, the data would still be accessible by normal
methods.
Managing feedbackEarly versions of the software were made available to
a select group of users, where opinions were gathered.
Following these successful trials, the software was
made available to all Arup offices.
Because Arup operates in an open market even with
its in-house developed products, uptake depended on
user demand rather than policy. Uptake was high,
which created another QA challenge of managing the
large quantity of feedback from all offices.
In the early stages, developers maintained simple
lists of user requests and bugs. As the volume grew,
so did the need to have a better way to manage it.
After exploring options, which included commercial
products or developing its own tools, the development
technology
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QP•www.qualityprogress.com20
team decided to adopt a well-established and free
open-source tool, Bugzilla, to track bugs and requests.
The initial adoption of Bugzilla led to a sharp rise
in entries to the system. Arup also sold the software
to external organizations, which created even more
feedback to manage. So the team decided to limit the
number of people who could add items to the system
and filtered all incoming requests.
With the tool’s global growth, the original internal
client committee was ultimately no longer an appro-
priate vehicle for feedback and was disbanded. A new
regional client panel was formed with locally selected
representatives from each of Arup’s five global regions:
the Americas; the United Kingdom, the Middle East
and Africa; Europe; East Asia; and Australasia. For
commercial customers, focus groups were organized
to garner views.
Managing demandFeedback from the regional client panel showed the
initial attempt for global roll-out to more than 10,000
staff members was slow and frustrating, so the team
developed a deployment tool allowing the software to
be pushed to thousands of machines from one work-
station. This tool enabled another kind of QA to be im-
posed in the area of configurations.
To meet the large variety of user requirements, the
software had become very configurable, but at the cost
of consistency. So the developers also included the
ability to deploy a configuration and lock it down in
the development of the tool. This gave local managers
the ability to define, set and enforce local policy.
When Microsoft later improved its software deploy-
ment tools, the in-house tool was retired, but the abili-
ty to regionally define and enforce policy was retained.
Mail Manager search tool / figure 3
1
10/08/2011 19:21:54 Harry Becket
10/08/2011 15:47:12 Tom Jones
10/08/2011 03:38:16 Tom Jones
22/07/2011 11:40:26 Alan Rogers
22/07/2011 10:12:51 Alec Milton
20/07/2011 17:50:14 Harry Becket
13/07/2011 11:17:18 Stuart Mason
22/06/2011 19:34:52 Tom Jones
22/06/2011 07:41:28 Alec Milton
21/06/2011 19:04:45 Tom Jones
02/06/2011 23:40:38 Allison James
13/05/2011 17:57:52 Jonathan Troy
10/01/2011 17:38:12 Alec Milton
08/01/2011 02:15:11 Allison James
1
1
CSV
RE: Quality Progress articleAlec MiltonSent: 06/01/2011 08:54:16To: Allison JamesCc: Simon Martin; Tom JonesFolder:\\global\london\stg\jobs\oasys\business\5-04relationships\ABC Corp\email
Thanks Allison,
I hope the Quality Progress article proves to beuseful.
Quality
Quality
Search status: 110 item(s) found
Indexing status: Finished
Ranking Sent Date From
ClearqualityABC Corp
Op
tio
ns
File
Date Range
Edit View Tools Help
31
Oasys Mail Manager - Search
March2012•QP 21
Exceeding expectationsArup’s resulting tool, Mail Manager, con-
sists of a plug-in to Microsoft Outlook that
provides access to the main features via a
“ribbon” menu, shown in Figure 1 (p. 19).
The plug-in suggests a filing location based
on the user’s previous behavior.
After a location is selected, the mes-
sage is flagged for filing and tagged with
its destination. A separate background filer
component completes the process. This
separation ensures the software is always
responsive to the user and enables filing
from a mobile device and the ability to
work offline.
The background filer component (Fig-
ure 2, p. 19), which sits in the tray, looks for
work to do every few seconds and under-
takes the filing tasks from Outlook, a mobile
phone, tablet device or Outlook Web Access.
There is no server component to Mail
Manager. This important design decision removes con-
cerns about destabilizing the email server and greatly
eases acceptance by users and IT personnel.
The search tool, shown in Figure 3, includes key-
word highlighting and near-instantaneous results,
maintaining a local copy of its index in the user profile
that only contains data from filing locations the user
has searched. This keeps the index small and allows
the user to search while offline.
Recently, Arup developed a new capability that al-
lows users to produce a diagram from the search re-
sults (Figure 4). The diagram shows the names and
email addresses of the contacts from the search results
in boxes, with the size of each box representing the
number of emails sent by that contact. This has proved
useful in discovering communication gaps and identi-
fying who is maintaining client relationships.
If Microsoft Exchange is the email server and it
contains staff photos, they are incorporated in the dia-
gram. This capability provides a human dynamic to the
function and highlights the key people involved in the
communication.
Capturing a portion of the screen and marking it
up as part of an exchange was found to be a frequent
but convoluted process. So a snap ‘n’ send function
was created to provide easy screen capture, markup
and creation of the content as a PDF attachment to
an outgoing email.
The success and acceptance of the tool can be at-
tributed to:
• As a plug-in to Outlook, user adoption is quicker
due to seamless integration with a familiar and fre-
quently used interface.
• By building technology that remembers the filing
habits of each user and provides logical prompts for
filing locations, the percentage of incorrectly filed
emails is greatly reduced.
• Integratingfilingintotheroutineofsendingandre-
ceiving an email creates a natural flow for users to
file emails immediately and eliminates the psychol-
ogy that managing emails is a separate and time-
consuming task.
• TheabilitytofileemailsinMicrosoftnativeformat
in project folders dramatically decreases IT storage
costs and increases QA on project documentation
and e-discovery.
• Afast,powerfulandeffectivesearchandretrieval
tool was essential in building user appreciation and
trust in the system.
• By avoiding the creation of a proprietary storage
system and filing emails to native file system folders
in Microsoft native MSG format, all concerns about
the long-term viability and accessibility of the data
are removed.
technology
Diagram of search results / figure 4
Oasys Mail Manager - Email Relationships
2.63x
1.1
Fill
Simon [email protected]
Harry [email protected]
Allison [email protected]
Stuart [email protected]
Alan [email protected]
Alana [email protected]
Robert [email protected]
Jonathan [email protected]
Dwight [email protected]
Eric [email protected]
Alec [email protected]
QP•www.qualityprogress.com22
The Arup developers created a popular software
tool because they listened and responded to user
needs. QA provided a framework for them to do so.
The system has changed significantly over time to
integrate new technologies and support new devices.
Advances in the capabilities also evolved with time.
These include updating the search tool to return re-
sults in less than one second and to highlight keywords
in its own preview window. Intelligence continues to
be added so the software learns and adapts to individ-
ual user behavior.
Measured savingsThe intent behind the software was to treat email com-
munications with greater care and ensure messages
can be found when needed. But in creating and licens-
ing the software, other benefits have been realized by
the tool’s users:
• MessageskeptinOutlookconsumemorediscspace
than when stored as MSG files. Stephen Dexter, a
chartered accountant in Oxford, England, found
that moving his data from Outlook to file system
folders reduced his disc space usage to 39% of its
previous size. To a company of Arup’s size, this rep-
resents a huge saving in storage costs.
• MorganCareyArchitects,afirmbasedinEngland,
claims that using Arup’s approach to email manage-
ment has cut the company’s paper use by 33%.
• ArrisContractingCo. inPoughkeepsie,NY, said it
believes it is avoiding thousands of dollars in stor-
age costs and about 70 man hours per month of
searching for information.
• Gensler Architect’s quality manager, Monica Par-
rott, said she believes the global architecture, de-
sign, planning and consulting firm has reduced
more than 280 man hours per week of administra-
tive work by using Arup’s approach.
• Bruce Sobocinski, IT manager for Highland As-
sociates, an architecture, engineering and interior
design firm headquartered in Pennsylvania, said
he now saves six to eight hours per week due to
eliminating the need to search former employee and
project files for critical emails. Before implement-
ing Arup’s model, Sobocinski said he received a
minimum of two requests a week requiring him to
perform this tedious task.
• MichaelKenealy,acertifiedpublicaccountantand
vice president and chief financial officer of Nitsch
Engineering in Boston, estimates his company
has saved more than $10,000 in storage costs and
continues to save staff countless hours associated
with e-discovery.
Lessons learnedFrom the development and implementation of Arup’s
email management software, seven key lessons have
been learned:
1. If everyone’s ideas were adopted, the final product
would have been complex and potentially unusable.
Although it was important to listen to everyone,
there must be measures in place for filtering ideas.
2. It is important to keep people informed, even when
there is no progress. If a problem, such as a bug,
arises, let them know what is happening, even when
you have hit a brick wall in terms of solving it. If you
are silent, the users will assume you are ignoring
them. If you keep them informed, they are usually
incredibly tolerant.
3. While QA procedures and project management pro-
cesses can be taught, it is not wise to assume every-
one involved is in tune with QA. Because software
developers tend to be creative thinkers, they need
the balance of those using the product for practi-
cal application. It is important to introduce the right
mix of skills and opinions into the process for the
optimum result.
4. Although it is tempting to jump right into develop-
ment, it is more cost effective to take time to stand
back, listen and plan well. This will result in less re-
work throughout the project and ultimately a better
product.
5. When adding technical staff to the process, fine-tune
the recruitment process. Test skills with exams, and
balance that with open questions to gauge the can-
didate’s ability to solve problems with appropriate
solutions.
It is important to keep people informed, even when there is no progress.
March2012•QP 23
6. Address the whole problem, not just the one in
front of you. If Arup’s developers had not produced
their deployment tool, widespread adoption would
have been thwarted.
7. Well-designed systems and processes save time.
Prior to adopting the Arup tool, 34.1% of commer-
cial users reported spending two or more hours per
day finding email. After adopting the tool, that fig-
ure was reduced to 0.9%.8
The QA answerNot every company has the capabilities to create soft-
ware to address issues with unstructured email data.
But every company has the capacity to use QA guide-
lines to approach a solution and determine which
ones are actually solving the entire problem.
Continuing to look at the issue as a whole while
enlisting experts, users and commonly available tools
to microscopically manage each step typically garners
the best results. Every piece of the process is vitally
important, and establishing open communication
within a realm of structure is the only way for the best
ideas to come to fruition.
In searching for tools and systems to tame and
implement email management, be sure to ask these
basic questions:
• Will this make email data more accessible and
transparent?
• Willteamsincreaseproductivitybyusingthissys-
tem?
• Is it likely employeeswill easily adopt this solu-
tion?
• Isthisgoingtosavetimeandmoneyfortheorgani-
zation?
• WillthisreduceITcostsandproblemscausedby
email-related issues?
• Willmy data be available tome in five, 10 or 15
years if this technology is no longer available?
If you answer no to any of those questions, stop
and rethink your approach. Assemble a diverse and
knowledgeable committee—preferably not just peo-
ple who volunteer to be on a committee—and take
time to ensure you are still committing to a solution
that will ultimately be an asset—not a hindrance—to
business objectives. QP
NOTEoasys, Arup’s software house, achieved ISo 9001 plus tickIt certification in
March 2004 through lloyds Register. this status continues to be maintained.
REFERENCES1. oasys ltd., “oasys: 96% of employees Say Poor email Management exposes
their company to legal Risk,” oct. 25, 2011, http://www.oasys-software.com/media/press/oasys%20Mail%20Manager%20Survey%20Release%20(october%202011).pdf (case sensitive).
2. Kevin F. Brady, “Should Metadata Automatically Be Produced?” www.cgoc.com/files/Brady_Metadata.pdf (case sensitive).
3. eric J. Sinrod, “the new e-Discovery Burden,” oct. 17, 2007, http://news.cnet.com/the-new-e-discovery-builder/2010-1030_3-6213845.html.
4. Alec Milton, “5 email tips that can Save Millions of Dollars,” Construction Executive, January 2012.
5. Accenture, “Managers Say the Majority of Information obtained for their Work Is Useless, Accenture Survey Finds,” Jan. 4, 2007, http://newsroom.accenture.com/article_display.cfm?article_id=4484.
6. craig carpenter, “Information Risk—how Much Is it Worth to you?” http://www.bcs.org/content/conwebdoc/22457.
7. Ibid.8. oasys ltd., “oasys: 96% of employees Say Poor email Management ex-
poses their company to legal Risk,” see reference 1.
technology
A growing investigational drug management provider has multiple openings in Frederick, MD, for the following positions:
Managers, Packaging & Labeling. Plan, coordinate, supervise, and control packaging and labeling activities in compliance withapplicable regulatory standards, cGMP regulations, and applicableSOPs. Design and develop container closure system for pharmaceutical formulations packaging. Maintain and monitorpackaging and labeling facility. Requires B.S./M.S. (or equivalent) in pharmaceutical science or chemistry. Code #102.
Facility Engineer, QA/QC (Validation/Calibration). Develop procedures for validation, quali cation, calibration, and maintenance of various test and operating equipment. Perform facility temperature mappings and equipment validations/calibration. Maintain hardware of data acquisition systems, calibrate DAS boards. Design and maintain data acquisition and instrument control using VB 6.0, ASP, COM+, JSP, J2EE, VBActiveX, ADO, SQL Server 2000. Requires B.S./M.S. (or equivalent) in science or engineering. Knowledge of cGMP regulations; federal/state/local regulations pertaining to operations, administration, maintenance, and safety of test and operating equipments. Code #104.
Requires 3-5 years experience in job offered or related technical or analytical role. Employer will accept any suitable combination of education/training/experience for some positions.
Mail résumés referring code number to:HR, EMINENT Services Corporation
7495 New Technology WayFrederick, MD 21703
EOE
ALEC MILTON is CEO of Oasys Ltd. in London, a fellow of the British Computer Society and a member of the Institution of Engineering Designers. He earned a bach-elor’s degree in engineering design from London South Bank University.
Anyone fAmiliAr with purchasing and
implementing business application software for organizations
regulated by the U.S. Food and Drug Administration (FDA)—
pharmaceutical, medical device or biotechnology companies
in particular—knows the effort is not a small one.
After an application has been selected and purchased,
the validation approach required for conventional software
implementation can take weeks or even months of effort
from IT and other resources. These requirements, however,
are well-known and understood.
In 50 Words Or Less • Softwareasaservice
(SaaS)applicationsaregrowinginpopularitybecauseoftheireaseofuse,buttheypresentsignificantissuesforFDA-regulatedorganiza-tions.
• BymanagingSaaSprovidersastheywouldotheroutsourcedser-vices,FDA-regulated
organizationscanensurecompliance.
Doesinternet-basedsoftwarehave a place inhighly regulated industries?
byJimDoughertyandWyleneLengel
March2012•QP 25
Technology
QP•www.qualityprogress.com26
Some companies are moving away from conven-
tional software and adding software as a service (SaaS)
applications, which use a software distribution model
in which applications are hosted by a vendor or service
provider and made available to customers over the in-
ternet.
Developed and maintained by the software vendor
at its locations, SaaS applications are typically pur-
chased as a subscription based on the number of users
or number of transactions.
In simple terms, SaaS is on-demand access to soft-
ware via the internet. It seemingly eliminates the in-
stallation and testing of the software by the custom-
er—or does it?
And how do FDA-regulated organizations prove
they have validated these systems when the installa-
tion and testing are done at the software vendor’s site?
How do those organizations provide the proper docu-
mentation to regulatory authorities for SaaS-supported
operations?
SaaS benefitsThe breadth of available SaaS applications is rapidly
expanding to encompass a variety of business applica-
tions, including many that fall under FDA regulations.
Examples of SaaS applications that typically don’t fall
under FDA regulations include project management,
customer relationship management, HR management
and sales automation.
Examples that fall under FDA regulations include
electronic laboratory notebooks, clinical trial data
management, employee training, inventory control,
distribution and pharmacoviligance—the study of data
surrounding a drug’s adverse effects. In addition, many
organizations are now using SaaS applications for
backup storage of their network data, some of which
fall under FDA regulation.
Given their compelling business case, it’s no sur-
prise that SaaS applications are growing in popularity.
Customers are shifting to SaaS for a variety of benefits,
such as:
• Easyleveragingoftheapplicationfromtheinternet
to support a mobile workforce or a workforce lo-
cated in multiple locations.
• Immediateavailabilityofthelatestversionforall
customers, eliminating the need for multiple in-
stallations or to roll out upgrades across multiple
sites.
• Advantages of scalability with subscription use,
which makes it easier to accommodate changing
business needs.
Perhaps the most significant benefit is lower overall
cost of ownership to each customer because of:
• Acceleratedsoftwaredeployment.
• Hardwarerequirementshandledbythevendor.
• Operationalandmaintenancecostsincurredbythe
vendor.
• FewerITandqualityassuranceresourcesrequired
for deployment, testing and maintenance.
on the riseAs SaaS rapidly increases in popularity—Information-
Week Analytics recently found that 60% of companies
use SaaS solutions, 13% more than last year1—the ques-
tion of validation presents challenges to firms in FDA-
regulated industries. Can regulated companies take
advantage of this new wave in business applications?
FDA-regulated organizations are responsible for en-
suring that any software used to help manufacture or
manage data about a product—or other software used
in any regulated application—is typically validated us-
ing the approach in Figure 1.
This validation approach puts in place documenta-
tion that can be audited by the FDA or other regula-
tory agencies. The documentation provides evidence
the software meets applicable regulations, such as
part 11 of the FDA’s Code of Federal Regulations Title
21.2
For example, one requirement is that an audit trail
can be generated to record all changes made in the
system, including the change itself, the user who made
the change and the date of the change. A test proto-
col would be written and executed to verify that this
requirement could be met and the actual test result
matches the expected result defined in the test proto-
col. This provides evidence that the audit-trail require-
ments are indeed met.
outsourcing comparisonA significant concern for organizations regulated by
the FDA—or any comparable international agency—is
the loss of direct control that occurs with the imple-
mentation of a SaaS system. Similar concerns exist
regarding the outsourcing of other activities, such as
engaging with a contract manufacturer.
These regulated organizations typically conduct
March2012•QP 27
an initial validation and subsequent related activities,
such as change control and upgrades in their own fa-
cilities with their own trained personnel so the activi-
ties can be closely controlled and documented.
In a SaaS environment, most of these activities are
conducted at the supplier’s site with supplier person-
nel and without client personnel present. This loss of
direct control is new and disconcerting to most regu-
lated organizations.
Using and overseeing a SaaS system is analogous to
overseeingotherregulatedoutsourcedactivities.Out-
sourcing across the value chain has been increasing
among life-sciences companies, and many regulated
companies are moving toward virtual manufacturing,
providing a framework for SaaS.
The general concept is that experts in a given arena
provide the services they do best. The critical part is
how these regulated companies leverage and manage
the expertise. It is important to note that the regulated
company—not the SaaS provider—is ultimately respon-
sible for compliance with the applicable regulations.
Do your homeworkA common practice among regulated companies is
to perform an audit of the potential supplier’s quality
systems prior to the selection of a software system for
traditional implementation.
Pre-selection and ongoing audits are of greater sig-
nificance to SaaS suppliers than conventional software
vendors because greater reliance is placed on a SaaS
supplier’s quality systems. So, in addition to the pre-
selection audit criteria, a SaaS supplier audit should
emphasize areas in which the SaaS supplier maintains
control of specific processes, such as:
• Locationandcontrolofdatacentersusedtostore
the software and client data.
• Changecontrolofhardwareandsoftwareforongo-
ing updates or upgrades.
Technology
Computer system validation model/Figure1
Backupand
archiving
• User requirements• Vendor evaluation
• Vendor report• Vendor documentation
• cGMP assessment• 21 CFR Part 11
assessment and report
Validationmaster plan
Validationsummary report
Userrequirements
PQ plan andPQ report
OQ plan andOQ report
SOP creationand system
training
IQ plan andeducation
IQ report
Configure and customize
Functional requirements and design specifications
cgMP=currentgoodmanufacturingpracticesiQ=installationqualificationOQ=operationalqualificationPQ=performancequalificationSOP=standardoperatingprocedure
Source:internationalSocietyforPharmaceuticalengineering,The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture, version5,January2008.
QP•www.qualityprogress.com28
• Data security—protection of data used by more
than one organization from corruption and unau-
thorized access.
• Physicalandlogicalsecurity,suchasuseridentifi-
cation, passwords, and roles and privileges.
• Backupandrecovery.
• Communicationmethodsandtimelinesforcustom-
er notification of software updates or upgrades.
The history and past performance of the SaaS
supplier also should be considered, along with the
number and types of other customers successfully
using the system. This is often a challenge because
most SaaS applications for regulated operations are
relatively new and therefore don’t have an extensive
history.
Procedural updatesSite and corporate computer system validation proce-
dures should be reviewed for compatibility with the
SaaS model well in advance of initiating a SaaS project.
These procedures would have been written to address
conventional software applications and likely contain
elements that are incompatible with a SaaS project and
lack elements necessary for the validation of a SaaS
system.
Procedures should be revised to include a frame-
work for the management of SaaS providers and vali-
dation requirements for SaaS applications based on a
risk assessment. Ample time must be allocated for re-
vision, review and approval of the procedures to avoid
a state of noncompliance with approved procedures.
Validation considerationsIn many respects, the validation approach for a SaaS
system is similar to that of a conventional system. The
organization would still apply an overall risk-based ap-
proach, documenting business and regulatory risks,
and areas needing more robust validation.
Factors contributing to the risk analysis include re-
sults of the vendor audit, criticality of the data and pro-
cesses captured in the SaaS system, and the degree of
customization—as opposed to configuration—of the
SaaS application.
Perhaps the most significant concern regarding
the validation and ongoing maintenance of SaaS sys-
tems is software updates. In FDA-regulated organiza-
tions, changes are reviewed and made, the version
number of the software is advanced, and the testing
is completed to maintain the validated state of the
software.
The testing is performed using a computer system
validation method depicted in Figure 1. Industry prac-
tice is to update software in a development environ-
ment, perform validation testing in a quality assurance
environment and transfer the update to the production
environment after successfully completing testing.
It’s common for this process to occur annually for a
specific software upgrade because it is a large under-
taking. In contrast, SaaS suppliers commonly perform
periodic software updates, often at specified times.
For example, minor changes are made to the software
weekly, while major changes are made quarterly.
out of the loopThe reality of SaaS systems is that upgrades are per-
formed by the supplier at the supplier’s facilities, and
they often occur with no regard for any validation ac-
tivities that may be required by the client.
Indeed, the client typically does not have any input
intowhenorhowoftenupgradesareperformed.Be-
cause of this, procedures must be established describ-
ing the update process, and should include how and
when proposed changes are communicated to the cli-
ent prior to the upgrade.
The procedure also should include a description of
how the evaluation of proposed changes will be han-
given their compelling business case, it’s no surprise that SaaS applications are growing in popularity.
March2012•QP 29
dled and documented by the client, and how feedback
regarding supplier testing of the proposed changes will
be handled. Test results can be either directly shared
with the client, shared only if there was an issue or be
available for review during an audit.
Oneareathatmayresultinacontentioussituation
is customer evaluation of proposed software changes.
Many SaaS providers are accustomed to operating in an
environment in which changes are designed, planned
and implemented internally with no or minimal com-
munication with their customers. FDA-regulated or-
ganizations will require that the proposed change be
reviewed and tested, and the results documented in a
manner that complies with the applicable regulations
and supporting procedures.
Many SaaS providers have a variety of customers,
most of which are not regulated by the FDA and are
not accustomed to meeting these requirements. The
SaaS suppliers may view the specific requirements of
one—or a very small percentage—of their customers
to be excessively burdensome and may resist.
in complianceOrganizations thatmustcomplywithasetof regula-
tions must have some degree of creativity and mutual
understanding to reach an agreement that satisfies the
SaaS provider and the regulated customer.
In most cases, qualification of infrastructure—hard-
ware such as servers and cables—can be performed
in a manner similar to that of traditional applications.
Many SaaS suppliers maintain a robust infrastructure
qualification and change-control system, but potential
red flags for FDA-regulated clients include cases in
which the provider does not and will not perform ad-
equate infrastructure qualification.
For example, the supplier may move data from one
server to another at a different loca-
tion without proper qualification or
may not maintain adequate docu-
mentation. These types of issues
present challenges similar to those
encountered when dealing with
suppliers of conventional software
systems that do not understand the
needs of regulated customers.
Physical and logical security,
backup, recovery and disaster recov-
ery can be addressed in the same way
as conventional software validation. The important dis-
tinction is that these elements be addressed at all rel-
evant locations and properly documented. Some SaaS
suppliers use secondary or backup locations in addi-
tion to their primary location, and there can be a ten-
dency to overlook procedures at the backup locations.
Conventional software validation occurs when an
organization’s personnel follows its procedures at its
own facility. SaaS validation typically occurs off site
with SaaS supplier personnel performing much of the
work. Diligence must be exercised to ensure the SaaS
supplier personnel are properly trained in the applica-
ble validation procedures, whether these procedures
are provided by the SaaS supplier or the client.
For situations in which SaaS supplier procedures
are used, the adequacy of these procedures should
be verified during the vendor audit. These procedures
should be referenced in the project validation plan.
working togetherOnelastvalidationconsiderationistheinterfacesbe-
tween a SaaS system—regardless of whether it con-
tains FDA-regulated information—and a customer’s
validated systems. These interfaces must be identified
and validated.
For example, an organization may interface its
own learning management system with a SaaS human
capital management application. The learning manage-
ment system contains employee training records, and
because maintaining employee training records is a re-
quirement for FDA-regulated organizations, the learn-
ing management system is fully validated.
In this case, the nonvalidated SaaS human capital
management system transfers employee data to the
learning management system through an interface that
must be validated to ensure data integrity. This can be
Technology
SaaS validation approach/Figure2
• User requirements
• Vendor evaluation
• Vendor report
• Vendor documentation
• cGMP assessment
• 21 CFR Part 11assessment and report
SOP creation andsystem training
Ongoing vendormanagement
cgMP=currentgoodmanufacturingpracticesSOP=standardoperatingprocedure
QP•www.qualityprogress.com30
accomplished in a similar fashion as for conventional
software systems.
It’s all too easy to overlook the validation of inter-
faces, particularly when the SaaS system being de-
ployed is classified as nonregulated but still interfaces
with validated systems.
The validation approach for SaaS is similar to that
for a conventional software system (see Figure 2, p.
29). An assessment of applicability of FDA regulations
to the system—known as a current good manufactur-
ing practices assessment—is performed to confirm
that the system falls under the regulation and requires
formal validation.3 User requirements are defined and
used as criteria for choosing the software.
The vendor audit becomes more significant because
it will be leveraged for ongoing management of the
vendor. Most, if not all, of the typical validation deliv-
erables—such as installation, operational and perfor-
mance qualifications—may take on a different format
because testing will be handled by the SaaS provider.
An exception is interfaces, which the organization
must address. Management tools specific to the organi-
zation, such as a quality agreement, would be included
in the ongoing vendor management, as is typical for
managing outsourced activities.
The introduction of a new validated system requires
introducing supporting standard operating procedures
andprovidingtrainingfortheusers.Ongoingmonitor-
ing of the SaaS supplier’s quality systems and periodic
audits also are part of the process.
Adapting for the futureSaaS applications are here to stay. Their presence in
the marketplace will continue to grow as more compa-
nies leverage the applications’ advantages. This means
SaaS providers interested in marketing their applica-
tions to companies in FDA-regulated industries will
need to understand regulatory requirements and take
the proper steps to ensure compliance.
In addition, regulated organizations must expand
their computer systems integration and validation per-
spectives beyond conventional applications to include
management of SaaS applications vendors.
To put it simply, organizations must manage SaaS
providers to ensure the delivery of reliable and secure
services just as they would manage other third-party
services, such as raw-material procurement, contract
manufacturing or product distribution.
These new relationships will require some under-
standing and education by the SaaS suppliers and the
firms purchasing their services. The upside is that the
technologies for compliant software systems already
exist, as do the validation methods to support them.
It’s just a matter of the suppliers and the purchasers
adapting them to the SaaS model. QP
RefeRenCeS1. PR newswire, “new InformationWeek Analytics Research Finds 60% of
companies Using Applications in the cloud,” April 19, 2011, www.prnewswire.com/news-releases/new-informationweek-analytics- research-finds-60-of-companies-using-applications-in-the-cloud-120196859.html.
2. U.S. Food and Drug Administration, “code of Federal Regulations Title 21,” www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=11.
3. International Society for Pharmaceutical engineering, The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture, version 5, January 2008.
BIBLIOgRaphyU.S. Food and Drug Administration, “general Principles of Software Validation;
Final guidance for Industry and FDA Staff,” Jan. 11, 2002, www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/ guidancedocuments/ucm085371.pdf.
JiM douGherTy is a director at Clarkston Consulting in durham, NC. he earned an MBA from the university of North Carolina-Greensboro. A senior member of ASQ, dougherty is an ASQ-certified quality engineer.
WyleNe leNGel is a director at Clarkston Consulting. She earned an MBA from Wichita State university in Kansas. lengel is a senior member of ASQ and an ASQ-certified quality auditor and engineer.
Technology
SaaS applications are here to stay. Their presence in the marketplace will grow as more organizations leverage the applications’ advantages.
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Rethinking Design
In 50 Words Or Less • Althoughdesignthink-
ingisn’trootedinthequalityworld,thestrate-gysharesmanysimilari-tieswithpopularqualitymethods.
• Byadoptingthisthree-phaseapproach,it’spossibletosolveavarietyofproblemsandmakequalityagreateremphasisatanyorgani-zation.
Embracingdesign thinkingcanhelporganizationsboosttheirprocess improvement efforts
byThomasGattiker
March2012•QP 33
Rethinking Design
Problem Solving
Design Thinking Began as an approach
to designing products and services. More accurately, it’s an
approach that involves designers early in the process—dur-
ing concept development—rather than having them focus
merely on the aesthetic aspects of already developed ideas.
Compared with conventional design practices, design
thinking also concentrates heavily on the subjective expe-
rience of the end user. Practitioners of the approach con-
sider themselves to be designers of experiences rather than
designers of products and services.
Design thinking’s roots lie in commercial design firms
and design schools. More recently, it has transcended the
boundaries of the product design profession and has been
embraced by a variety of organizations and thought lead-
ers. Design thinking has made its way into the curriculum
of major business schools, such as Harvard University and
the Massachusetts Institute of Technology, and has been
championed by prestigious consulting firms and managers
of other influential organizations.1
QP•www.qualityprogress.com34
For example, IDEO, one of the leading practitioners
of design thinking, was highlighted in Businessweek
for its efforts to show “global corporations how to
change their organizations to focus on the customer.
... Indeed, [IDEO] is now a rival to the traditional pur-
veyors of corporate advice: the management consult-
ing companies such as McKinsey, Boston Consulting
and Bain.”2
Currently, organizations employ design thinking as
an approach for solving an array of problems, includ-
ing the design and improvement of business process-
es, especially service processes. Because of that, you
might expect that design thinking has diffused far into
the realm of the quality professional, especially in the
area of services, where the creation and consumption
processes—or, to put it another way, the customer ex-
perience—are often inseparable.
But there is a notable lack of spillover into the qual-
ity world. Here’s why it’s time to change that:
• Design thinking offers several tools and concepts
that can complement problem-solving approaches
normally taught and used by quality professionals.
• Althoughdesignthinkingdiffersfromthemethods
and mindset of the quality profession in significant
ways, the similarities between the two worlds are
even more significant. Therefore, quality profes-
sionals are good candidates to start or lead design
thinking initiatives in their organizations.
inspiration strikesTim Brown, one of the major developers of design
thinking, said, “The design process is best described
metaphorically as a system of spaces rather than a pre-
defined series of orderly steps.”3 Despite that, articles
and training materials for design thinking outline a se-
ries of phases and activities in these phases.
Design thinking is most commonly described as
consisting of three steps: inspire, ideate and imple-
ment. Table 1 provides an overview of those phases
and the activities in each phase.
The inspire phase begins with defining the chal-
lenge or creating a project brief—a broad problem
or opportunity statement. For example, a major bank
stateditsdesignchallengeas:“Attractnewcustomers
with an emphasis on boomer women with kids.”4An
internal medicine practice working with facilitators at
Boise State University stated its design challenge as:
“Provide better care for geriatric patients.”
One characteristic of a well-structured design chal-
lenge is that it is focused on the user experience and
the benefit to the user. It should also be broad enough
that it doesn’t preclude unexpected solutions or unan-
ticipated areas of inquiry.
The second step in the inspire phase is observing
processes and people, such as users or potential cus-
tomers. Design thinking offers many observational tech-
niques. Some of these—such as focus groups, surveys
and shadowing—are already familiar to most individu-
als who are involved in analyzing business processes.
But design thinking is unusual in its embrace of distinc-
tive ethnographic techniques. Some examples include:
• Guided tours—subjects take observers on a nar-
rated tour of relevant spaces and activities.
• Camera journal—subjects keep a visual record
of their role in a process or their experience with a
product.
• Personal inventory—subjects describe the ob-
jects that are most important to them, which helps
the problem-solving team understand participants’
experiences.5
When it comes to information gathering, design
thinkers often strive to observe uncharacteristic indi-
viduals, such as the handicapped or someone who has
never used a common household product, and fringe
users, such as those who use products for purposes
other than they were intended. It’s important to gather
information from such groups in addition to typical us-
ers because they may be particularly attuned to defi-
ciencies in current processes and products.
inspiration
1. Definetheproblem.
2. Gatherandsynthesizedatathroughdirectobservationandothermeans.
ideation
1. Frameopportunities.
2. Brainstorm.
implementation
1. Prototypeandtest.
2. Rolloutthesolutionandsellinternally.
Adaptedfrom“DesignThinking”byTimBrown,Harvard Business Review,June2008,http://hbr.org/2008/06/design-thinking/ar/1.
Design thinking process summary/TABlE1
March2012•QP 35
got an idea?The ideate phase begins with framing opportunities,
which serves as a bridge between the information
gathering that occurred during the inspire step and
idea generation, which comes later. The goal of op-
portunity framing is to distill the problem down to a
one-sentence statement. “How might we” and “I want”
statements are two useful ways to approach this task.
For example, after learning about the anxiety of tar-
get customers struggling to manage and save money,
the team from the bank mentioned previously crafted
this statement: “How might we integrate savings into
people’s everyday lives to help them save effortlessly?”
Customer point-of-view statements or “I want”
statements are an alternative means of framing oppor-
tunities. For example, after learning about patient and
caregiver difficulties stemming from the fragmented
nature of care, an internal medicine team devised this
customer want statement: “After being discharged
from the hospital, I want one point of contact for my
chronic care needs.”
Important outcomes from crafting opportunity
statements include the identification of the customer,
the customer need and the time or circumstances un-
der which the need occurs. This last consideration
deserves special mention because the circumstances
often define or bound potential solutions. For exam-
ple, the need for nutritious food when having dinner at
home is likely to be different than the need for nutri-
tious food when driving or at the office.
Opportunity statements should be broad enough
to allow a large number of solutions to be considered.
In the healthcare setting, statements such as “I want a
website to manage my chronic care needs” or “I want
a case manager” would be unnecessarily restrictive.6
The second step in the ideate phase is brainstorm-
ing—a tool used in many types of problem-solving ef-
forts. It is important to point out that design thinking
reserves brainstorming until relatively late in the pro-
cess, after extensive efforts to collect data, frame the
problem and refine how the problem is phrased.
Carrying out the planThe last of the three phases is implementation, which
includes synthesizing the output of brainstorming using
well-known tools, such as affinity grouping and multi-
voting. If this process is done effectively, several ideas
will emerge that can be carried forward as prototypes.
Design thinking approaches prototypes differently
than many other strategies by producing prototypes
earlier, more frequently and more cheaply. Generally,
prototypes are models or actual examples of prod-
ucts that are soon to be manufactured and sold. De-
sign thinking employs a “quick and dirty” approach by
building solutions cheaply using materials such as card-
stock, masking tape and Legos.
The belief is that investing too much time and re-
sources into prototypes can result in people becoming
overinvested in a particular idea, which can lead to the
failure to consider other solutions that may be better.
For example, when developing a new incubator
for infants, a team created more than 100 prototypes.
Design thinkers prototype processes using skits, sto-
ryboards and other methods. In one well-known case,
a team working on designing a new hotel concept for
business travel mocked up an entire guest room and
lobby using foam core. With this approach, prototyping
is a means to communicate and receive feedback from
others and refine the idea as it is implemented.
Common groundThe quality profession has several product and process
improvement methods at its disposal. In their authori-
tative quality management text, James R. Evans and
William M. Lindsay identify four dominant approaches:
1. TheDemingcycle(plan-do-check-actorPDCA)and
Shewhartcycle(plan-do-study-act).
2. Juran’s Breakthrough Sequence.
3. Creative problem solving.
4. Design, measure, analyze, improve and control
(DMAIC).7
There are differences among these methods to be
sure, but they’re outweighed by their similarities.8 In
fact, other authors have pointed out that these strate-
gies are “simple variations of each other.”9 Table 2 (p.
37)summarizesthecontentofthetwomajorproblem-
solvingprocessesinthequalityparadigm—PDCAand
DMAIC—andcomparesthemwithdesignthinking.
As the table shows, there are many similarities
among the modern quality paradigms and design think-
ing. For example, all of them follow the same general
logic, which can be characterized as consisting of
problem definition, data gathering, solution search, so-
lution evaluation and implementation.
They also place a heavy emphasis on understand-
ing process flow. Flow charts and process mapping are
Problem Solving
QP•www.qualityprogress.com36
common tools quality practitioners use to help under-
stand how processes actually occur in the organization
and to identify improvement opportunities. Similarly,
design thinking initiatives often include the creation of
a “customer journey” map.
Other techniques to understand process flow are
also used by design thinkers—for example, an initia-
tive at a financial services organization included doc-
umenting the life of a bill. Moving to a greater level
of detail, the traditional quality methods and design
thinking share some of the same tools—for example,
brainstorming.
These similarities suggest many quality profession-
als interested in design thinking will not find them-
selves on unfamiliar ground. They could appropriate
individual aspects of design thinking without exces-
sively burdensome startup costs.
The level of similarity also suggests that most qual-
ity professionals would be good candidates to lead
design thinking initiatives if their organizations do not
employ individuals or consultants who are already de-
sign thinking experts.
spotting the differencesThere are also noteworthy differences between de-
sign thinking and traditional quality strategies. Design
thinking’s information-gathering strategies tend to be
rooted in ethnographic methods as opposed to the data
gathering typical of other problem-solving methods.
Examples include shadowing customers and taking on
the role of the customer to build customer empathy.
For example, in a design thinking initiative aimed
at improving emergency room care, team members
playedtheroleofpatients.Akeyfindingwasrealizing
how much of the patient experience was spent lying on
a gurney awaiting care. Had team members not actu-
ally experienced this, it’s likely they would have not
understood the impact of this part of the process on
the overall customer experience.
Aswithmoretraditionalproblem-solvingtechniques,
quantitative data are a part of the mix—for example, re-
cording time spent in various stages of the service de-
livery process. But most design thinking initiatives also
include data gathering that is radically qualitative. For
example, bank customers were asked to draw pictures
of their money to elicit deeply or unconsciously held
feelings and beliefs about managing their finances.
Other differences can be thought of as differences in
emphasis. One of these is design thinking’s exception-
ally holistic conceptualization of a product or process.
For example, a team was tasked with redesigning
a train seat forAmtrak. Itdiscovered that frommost
customers’ points of view, the experience of train travel
included planning the trip, making a reservation, travel-
ing to the station, parking, waiting in line for the ticket
andthenboardingthetrain.Asaresult,thesolutions
they pursued went beyond the seat itself and encom-
passed elements such as the layout of the train station.10
In another example, a problem-solving team was
tasked with designing an incubator for infants that would
cost less than $250—1% of the cost of other incubators
on the market at the time—to help address mortality of
low birth-weight babies in hospitals in the developing
world. Consistent with design thinking’s ethnographic
emphasis, the team visited hospitals to observe users.
In doing so, it found that the hospitals already had many
incubators. More importantly, the team discovered that
many of the incubators were not being used.
The team was told that a large number of low birth-
weight babies never make it to the hospital and instead
dieonthewaytothehospital.Atthispoint,theteam
expanded its conceptualization of the process and be-
gan studying the practices and problems of mothers
caring for infants in rural villages and on their way to
urban hospitals, rather than focusing narrowly on what
happened in the hospitals.
The solution the team settled on was essentially an
insulated pouch that contains a removable pad that can
be heated in boiling water and deployed by mothers in
their home villages long before arrival at the hospital.11
By expanding the boundaries of the problem, the team
identified and solved the core problem.
Take the leadAt many organizations, the buzz surrounding design
thinking originates from top management or other ar-
eas outside of quality. But quality professionals should
not shy away from stepping up, participating in or even
leading design thinking initiatives. After all, a great
deal of the content of design thinking is already famil-
iar to most quality professionals based on their knowl-
edge of total quality management, Six Sigma and lean.
In doing so, quality professionals can increase the
influence of the quality function within their organiza-
tions while also contributing in new ways. More mod-
estly, many quality professionals will discover there is
Design thinking process* PDCa cycle** DMaiC method**
inspiration
•Definetheproblem.
•Gatherandsynthesizedatathroughdirectobservationandothermeans.
ideation
•Frameopportunities.
•Brainstorm.
implementation
•Prototypeandtest.
•Rolloutthesolutionandsellinternally.
Plan
•Defineordescribetheprocess.
•Describetheproblem.
•Determinewhatdataareavailableandwhatdataneedtobecollected.
•Identifyprimarycausesoftheproblem.
•Developpotentialchangesorsolutions.
•Selectthemostpromisingsolutions.
Do
•Conductapilotstudy.
•Identifymeasurestogaugewhethersolutionsweresuccessful.
Check
•Examinetheresultofthepilotstudy.Determinewhetherfurtherexperimentationisneeded.
act
•Selectandimplementthebestchangeorsolution.
•Createaprocesstomonitorandcontroltheprocess.
Define
•Identifycustomersandqualitycharacteristicsthatareimportanttothem.
•Describecurrentandexpectedperformance.
•Estimatecostandrevenueimplications.
Measure
•Collectdata.
•Estimaterelationshipbetweenprocesscharacteristicsandcustomersatisfaction.
analyze
•Conductrootcauseanalysis.
•Conductexperimentstovalidaterootcauses.
improve
•Generatepossiblesolutions.
•Evaluatepotentialsolutions.
•Implementsolutions.
Control
•Monitorandcontroltheprocess.
Colorsindicateparallelelements.PDCa =plan-do-check-actDMaiC=define,measure,analyze,improveandcontrol
*Adaptedfrom“DesignThinking”byTimBrown,Harvard Business Review,June2008,http://hbr.org/2008/06/design-thinking/ar/1.**AdaptedfromManaging for Quality and Performance Excellence,eighthedition,byJamesR.EvansandWilliamM.lindsay,Cengagelearning,2010.
March2012•QP 37
a lot to be gained from incorporating select elements
of design thinking into their process improvement tool
kit—for example, qualitative and ethnographic data
gathering.
Design thinking may overlap particularly well with
the needs of quality professionals when it comes to
improving service processes—whether they involve
external or internal customers. True quality profes-
sionals are always looking for ways to increase their
effectiveness, and design thinking offers the perfect
opportunity to do so. QP
RefeRences anD nOtes1. bruce nussbaum, “Design Thinking battle—managers embrace Design
Thinking, Designers reject it,” Bloomberg Businessweek, July 10, 2009, www.businessweek.com/innovate/nussbaumonDesign/archives/2009/07/design_thinking_3.html (case sensitive).
2. bruce nussbaum, “The Power of Design,” Bloomberg Businessweek, may 17, 2004, www.businessweek.com/magazine/content/04_20/b3883001_mz001.htm.
3. Tim brown, “Design Thinking,” Harvard Business Review, June 2008, http://hbr.org/2008/06/design-thinking/ar/1.
4. Scott D. Anthony, mark W. Johnson, Joseph v. Sinfield and elizabeth J. Altman,
Innovator’s Guide to Growth, Harvard business School Publishing, 2008.5. Design and innovation consulting firm iDeo publishes a set of method
cards, which is a deck of 51 cards that describe a method of gathering in-formation, analyzing or prototyping. The methods described in this section appear on these cards.
6. For more information on creating effective statements, see the Design Thinker workshop from experience Point, www.experiencepoint.com/sims/DesignThinker (case sensitive).
7. James r. evans and William m. lindsay, Managing for Quality and Perfor-mance Excellence, Cengage learning, 2010.
8. roger g. Schroeder, Kevin linderman, Charles liedtke and Adrian S. Choo, “Six Sigma: Definition and Underlying Theory,” Journal of Operations Man-agement, vol. 26, no. 4, pp. 536-554.
9. Anthony, Johnson, Sinfeld and Altman, Innovator’s Guide to Growth, see reference 4, p. 657.
10. ritesh bhavnani and manuel Sosa, “iDeo: Service Design (A),” european Case Clearinghouse, 2006.
11. greg Warman, “Design Thinking in Action: embrace global,” Feb 16, 2010, http://blog.experiencepoint.com/2010/02/16/design-thinking-in-action-embrace-global.
Problem Solving
comparing design thinking and problem solving/TABlE2
THOMas GaTTIkER is an associate professor at Boise state University in Idaho. He earned a doctorate in operations management from the University of Georgia in athens.
Inconsi st encyEradicating
Orkin’s internal audit process fosters more reliable service, reduces customer churn
March 2012 • QP 39
WHEN MOST PEOPLE imagine the Orkin
man, they visualize a uniformed technician driving a white
truck from house to house. What’s probably not as widely
known is that the technicians stop at many places other
than homes. In fact, about one-third of Orkin Inc.’s revenue
comes from its commercial business, which provides pest
control for food processing plants, hospitals, hotels and
other commercial facilities that have an extremely low
tolerance for pests.
As Orkin’s commercial business began to grow more
rapidly in the mid-1990s, the Atlanta-based company,
which employs more than 8,000 people and operates more
than 400 branch offices, realized its commercial services
were struggling with quality and consistency, which result-
ed in customer cancellations.
In 50 Words Or Less • Orkin was losing com-
mercial customers be-cause it struggled with consistency in service and quality.
• Orkin decided to focus on its audit process and formed a team to inspect and monitor internal activities.
• As a result, Orkin improved customer ser-vice, leading to higher retention rates.
case study
by Mark Udell and Mike Buffington
Inconsi st ency
QP • www.qualityprogress.com40
To address the issue, Orkin has spent the past de-
cade establishing and maintaining an ISO 9001-certi-
fied quality management system and internal audit pro-
cess. Along the way, Orkin overcame many challenges
to build a consistent, reliable quality system through-
out the organization that has measurably benefited its
business.
Starting with business customersAs more organizations around the world adopted ISO
9001 in the 1990s, Orkin’s commercial customers be-
gan asking whether Orkin was ISO 9001-certified.
Some of Orkin’s largest business customers had al-
ready earned ISO 9001 certifications, and they wanted
to partner with suppliers that subscribed to the same
quality management standard.
At the same time, Orkin’s leaders were looking for
new ways to create a more consistent, high-quality,
end-to-end service experience for its business custom-
ers—from every sales call to every service visit. This,
along with increasing customer demand for ISO 9001
certification in certain business segments, led Orkin to
require each of its dedicated commercial branches—
the 15 to 20-person local offices that served commer-
cial customers exclusively—to seek ISO 9001:2000
certification.
Each of Orkin’s commercial branches worked indi-
vidually to achieve ISO 9001 certification. A costly and
complex process, it required one internal Orkin audi-
tor to travel across the United States to evaluate each
of the 48 commercial branch offices operating at the
time.
The branch managers were expected to complete
tremendous amounts of paperwork as part of the pro-
cess. Orkin also retained an external auditor who in-
spected at least 25% of the branches every year, adding
to the expense.
As the commercial-only branches attained certifica-
tion, they began promoting the certification to busi-
ness customers and prospects. Left behind were the
locations that serviced commercial and residential
accounts, some of which had substantial numbers of
commercial accounts.
Admittedly, the patchwork of certified and noncerti-
fied branches might have been confusing to some cus-
tomers and prospects, who therefore could not expect
to see consistent ISO 9001 certification across Orkin
branches.
Shift in strategyIn late 2002, the limitations of a branch-by-branch ISO
9001 certification approach became apparent when
Orkin lost one of its largest and most prominent retail
customers: a national account with store locations in
all 50 states. Having individual branches attain ISO
9001 certification simply wasn’t helping Orkin achieve
the national consistency it sought.
The company moved quickly, and by early 2003,
under the direction of Vice President Chris Gorecki,
Orkin formed a formal quality assurance (QA) depart-
ment that would monitor all of Orkin’s branches and
business lines.
This new QA team was responsible for developing
and documenting a companywide quality manage-
ment process that would earn ISO 9001 certification.
By certifying its quality process rather than individ-
ual branches, Orkin could improve quality in every
branch, cut costs and retain its commercial customers
longer.
The first step was to create a comprehensive quality
policy manual that set forth—once and for all—clear
policies and procedures for each branch to follow with
every customer.
After the manual was published, the team launched
a full quality audit of all branches to assess perfor-
mance against these standards, which included:
• Orkin’s employee training requirements and
other operational standards. Covering course-
work from AIB International and three universities,
in-branch training, driver certification and more,
these standards ensure a higher level of profession-
alism and allow Orkin to meet customer needs more
consistently, especially in audited facilities.
• State and federal pest-control regulations.
These regulations vary by state and change periodi-
cally, so regular assessments of compliance are cru-
cial.
• Orkin’s service documentation protocols. Driv-
en by regulations and, in some cases, by customer
requirements, detailed service documentation is a
big part of delivering high-quality service.
• Agreed-on service protocols. Naturally, it’s man-
datory to deliver the service the customer con-
tracted Orkin to provide, and every quality audit
assesses the local branch’s delivery of Orkin’s stan-
dard commercial scope of service, plus any other
agreed-on service requirements.
March 2012 • QP 41
Compliance with individual customer require-
ments could be evaluated only through on-site audits
at customer locations. These inspections would assess
things such as whether the property was serviced with
the agreed-on frequency, a comprehensive inspection
was completed during each scheduled visit and the
appropriate number of insect traps were placed at the
business.
Overcoming obstaclesNot surprisingly, this first companywide quality audit
uncovered a need for greater consistency. Also, the
new QA team’s work was met with a lukewarm initial
response from branch personnel.
Some branches were creating and following their
own rules and policies when servicing an account, or
setting ISO 9001 certification goals that were easy to
attain and document. Others complained about “big
brother” monitoring their work.
Many branch managers argued that as long as they
responded to customer calls quickly and resolved pest
problems to a customer’s satisfaction, it shouldn’t mat-
ter whether they followed a written scope of service
to the letter.
Over time, the QA team—which was largely com-
prised of Orkin field veterans—was able to build trust
with the branches and help them see how a commit-
ment to consistency and process would actually allow
them to keep more of their customers happy for longer
periods of time.
Today’s quality management processIn 2005, Orkin earned ISO 9001 certification for its
companywide quality management system. This
change shifted the burden of responsibility for qual-
ity from individual branches to the QA department,
which improved quality while yielding significant cost
savings.
Shifting ISO 9001 certification from its commer-
cial branches to the audit process also eliminated the
need for a commercial ISO 9001 coordinator position
and the 16 external ISO 9001 audits that were required
each year to certify branches. This saved the company
nearly $125,000 per year.
In the meantime, implementation cost little be-
cause Orkin’s quality and compliance inspectors for
its termite business were already conducting quality
audits and could be cross-trained to perform commer-
cial quality audits as well. In addition, by eliminating
the branch downtime caused by the local ISO 9001
audits, Orkin regained some long-term operational ef-
ficiency.
Today, Orkin’s QA team is comprised of seven ex-
perienced quality professionals who have worked at
Orkin for an average of 30 years. Their long histories
with the company and deep familiarity with branch
operations has earned them the trust and respect of
branch teams across the country. Beyond experience,
the team also has completed technical courses and ISO
9001 internal audit coursework.
The QA team conducts at least 200 commercial
branch audits per year out of Orkin’s total of more than
400 U.S. branches. A typical branch audit is completed
by one auditor in four business days, during which
time the auditor must conduct at least:
• Nine administrative reviews (training records and
other important documentation) at the branch.
• Four company-owned vehicle inspections at the
branch.
• Tenon-sitecustomerinspectionsfromacrosssec-
tion of commercial accounts (hotels, office build-
ings, restaurants and hospitals) that are serviced
by a variety of pest specialists. The goal is to avoid
inspecting only high-performing accounts and thus
getting an inaccurate picture of the branch’s service
quality.
The auditor completes a QA audit workbook (see
Online Figure 1, found on this article’s webpage at
www.qualityprogress.com), which helps the auditor
assess each branch’s compliance with:
case study
The quality assurance team helped branches see how a commitment to consistency would allow them to keep more of their customers happy.
QP • www.qualityprogress.com42
• Orkinemployeetrainingrequirementsandotherop-
erational standards.
• Stateregulations.
• Orkinservicedocumentationrequirements.
• Agreed-on scope of service protocols (evaluated
through on-site audits at customer locations).
Categories are weighted to reflect their relative
importance in Orkin’s quality assessment model and
scored on a scale of one to four. Any score below 97%
requires follow-up processes. See more about the scor-
ing in the sidebar, “Scoring System.”
Auditors then use the two-page audit summary re-
ports to document their findings to the branches (see
OnlineFigure2).Eachbranchreceivesascoreonthe
following items:
• Administration(recordsanddocumentation).
• Employeetraining.
• On-siteserviceevaluationsatcommercialcustomer
locations.
Branches that serve termite and residential custom-
ers can also be reviewed and evaluated using this re-
porting tool.
On the last day of the audit, the auditor convenes a
branch training meeting for all employees. There, the
auditor shares the audit results, and highlights areas
in which the branch is excelling and areas in which
improvements are needed. Even branches that receive
very high ratings are given three to five areas of im-
provement to work on.
The quality team is committed to ensuring the
employees in the branch offices have a voice in the
process. Therefore, after an audit is completed, the
quality team director emails branch and region man-
agement asking for feedback and suggestions on the
audit process.
In accordance with ISO 9001:2008, if a branch fails
any portion of an audit, there is a formal corrective
process that requires the completion of specific ac-
tion steps.
Forexample,ifanauditrevealscertainpestspecial-
ists aren’t properly completing all paperwork, the qual-
ity team may require additional training for employees.
This process is administered and documented by the
appropriate Orkin region or division management, and
the branch must document the completion of its pre-
scribed action steps.
Finally, the QA team conducts a follow-up audit,
typically within 90 to 120 days, at branches that fail the
on-site inspection portion of the audit.
What’s good for the gooseThe quality team undergoes an audit of its own qual-
ity management process, too. Twice a year, Orkin’s ISO
9001 manager completes an exhaustive management
review of the QA team’s performance against its own
quality goals. Table 1 shows the QA team’s goals and
results for 2010.
If the QA team is not on track to meet its goals, it fol-
lows a corrective process similar to the one imposed
on branches, setting specific action steps that must
be taken and documented. In some cases, the branch
imposes preventive action recommendations on itself.
Forexample,itmightaddnewstepstoitsbranchaudit
process in anticipation of changes in service or train-
ing protocols.
Its 2010 scorecard showed that Orkin’s quality team
met its objectives for the year. The most important of
these objectives was the reduction in customer cancel-
lations. Between 2005—when the ISO 9001 certified
quality management system and internal audit process
was adopted—and 2010, Orkin’s commercial customer
cancellation rate dropped from 2.09% to 1.84%.
ForacompanyofOrkin’ssize,evenchangeassmall
as 0.1% in cancellations can have a significant impact
on revenue and profitability. By decreasing the cancella-
tion rate by 0.25% during the five-year period, Orkin pre-
served about $660,000 in customer revenue each year.1
ScOrIng SySTemWhen the Orkin auditor reviews administrative records and inspects
vehicles, the following scoring system is used to rate each branch:
• Commendable: 3.61-4.
• Above average: 3.21-3.6.
• Average: 2.81-3.2.
• Below average: 2.41-2.8.
• Unsatisfactory: 0-2.4.
Points are allocated based on the following guidelines:
• 4: Full compliance with company policy, no errors detected.
• 3: Minor exceptions noted, exceptions rate between 1 and 10%.
• 2: Number of exceptions reaches rate between 11 and 25%.
• 1: High amount of exceptions, including total disregard for company
policy.
For on-site customer service audits, anything below 97% requires
follow-up processes. —M.U. and M.B.
March 2012 • QP 43
Orkin’s internal audit process de-
creased cancellations by involving all
levels of management, including top ex-
ecutives. It fostered a culture of quality
in Orkin’s commercial operation. It paired
this quality mindset—which emphasized
measurable performance standards—with
consistent oversight and compliance, help-
ing the company to better meet customer
needs and avoid common service short-
falls that had contributed to cancellations.
Beyond the bottom-line benefits of re-
duced cancellations, Orkin’s ISO 9001 pro-
cess and QA audits helped Orkin:
• Establish service and quality consis-
tency across the entire organization, as
shown in Table 2.
• Bettermeetcustomerneedsinachang-
ing marketplace.
• Create an internal culture that fosters
quality, accountability and ongoing pro-
cess improvement, intangibly boost mo-
rale and add long-term value.
• Improve customer satisfaction from
2007to2009.Forexample,thepercent-
age of customers who rated Orkin’s ser-
vice as excellent or good increased from 95.8% to
97.7%. In 2010, when the company switched to a net
promoter satisfaction metric, 97.1% of Orkin’s cus-
tomers said they would recommend the company to
others.2
Employee and customer buy-inToday, employees in the branch offices value the QA
audits and view the quality team as a true internal part-
ner. Branch offices are appreciative of how the team
has helped them improve their business practices,
which has led to better customer retention.
Many branch offices turn to the team as an expert
resource for questions about training and technical or
operational policies and procedures. They know the
quality team is a valuable repository of the most cur-
rent and accurate information available.
Another benefit of Orkin’s new quality management
process was its reception by customers. Overwhelm-
ingly, customers viewed the audit process and on-site
evaluations as reaffirmation that Orkin is committed
to servicing their business at or above the agreed-on
scope. According to customer surveys and feedback
reports, customers were impressed that a supplier
such as Orkin takes quality so seriously and spends
time and resources to enforce quality controls—some-
thing many customers say is rare with their other sup-
pliers.
Lessons learnedHere are a few of the lessons learned during the past
five years as Orkin shifted processes and, more impor-
tantly, its mindset to support quality. It is hoped these
can be applied in other organizations:
• InadecentralizedserviceorganizationsuchasOr-
kin, maintaining quality is difficult without a clear
set of universal procedures and a centralized over-
sight process. This may seem intuitive, but many
organizations still operate without one or both of
these elements.
• Anorganizationalshifttowardqualitycontrolscan-
not happen without the involvement and support of
regional and local management.
• Oneof thekeys to successwas thatOrkin quality
case study
Goal Result
● Complete 200 commercial account audits. ✓ 200 completed
● Average 10 or more on-site inspections per commercial audit.
✓ Averaged 11 inspections
● Average at least four vehicle inspections per commercial audit.
✓ Averaged 4.5 vehicles
● Average at least nine administrative reviews per commercial audit.
✓ Averaged 12.5 reviews
● Reduce pest control service customer cancellation rate to 1.91%.
✓ 1.84% rate achieved
Key performance metrics—2010 / TABle 1
2005 2006 2007 2008 2009 2010
Commendable 28.3% 38.4% 35% 30.8% 32% 40.4%
Above average 24.1% 19.2% 19% 21.1% 27% 15.4%
Average 17.3% 18.4% 24% 24.1% 24% 26.9%
Below average 8.4% 2.4% 6% 7.5% 6% 4.5%
Unsatisfactory 22% 21.6% 16% 16.5% 11% 12.8%
Ratings are for on-site portion of inspections only
Quality audit process compliance trend since inception / TABle 2
QP • www.qualityprogress.com44
auditors operated in good faith, without ulterior mo-
tives and in partnership—not in opposition to—lo-
cal offices. One example of this mindset: Orkin’s
post-audit evaluation surveys ask branch managers
whether solutions were offered for any deficiencies
found. This coaching mentality is part of the success.
• Havinga teamofauditorswhocame fromOrkin’s
field operations added much-needed credibility to
the change effort.
Orkin continues to evaluate and improve its quality
management system to deliver consistent, high-quality
service. Orkin’s leadership knows that the mission to
be not only the best pest-control service, but also the
nation’s best service company, is a never-ending quest.
Last year, the QA team invested time and resources
to fine-tune its database management systems as the
company rolled out some new processes and services.
The quality team is already adding this new information
to the databases to ensure the team is ready to track
branch compliance and performance from the start.
While the journey to service delivery excellence is
not fast or easy, Orkin’s experience shows how the ap-
plication of ISO 9001:2008 can help a service organiza-
tion improve its quality performance metrics and better
meet customer expectations. QP
nOTeS1. this estimate is based on the number of commercial customers and aver-
age annual customer revenue.2. these percentages are from only the years for which data are currently
available.
Stay up to date on standards-related news and activities by visiting ASQ’s Standards Central. Find what’s new, what’s important, and what’s “hot” in the world of standards.
• Key Issues Impacting Global Standardization and Conformance (white paper)
• Shall vs. Should (a Standards Central article by Cynthia Blumenthal)
• And more!
To learn more about ASQ’s Standards Central, visit asq.org/standards today.
ASQ Standard’s Central
case study
MIKE BUFFINGTON is Orkin’s quality assurance director. He holds a bachelor’s degree in business from Mississippi State University in Starkville, MS. Buffington is an ASQ-certified quality auditor.
MARK UDELL is Orkin’s manager of ISO 9001, quality assurance and remediation in Atlanta. He holds a bachelor’s degree in education from Lewis University in Romeoville, IL. Udell is an ASQ-certified quality auditor.
May 21 – 23, 2012 • Anaheim, CAAnaheim Convention Center
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This must-attend conference will demonstrate the impact that quality can have on healthcare organizations and offer relevant and clearly measured results from improvement methodologies and processes that your organization can use.
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The Healthcare Division of ASQ strives to engage stakeholders at all levels in improving the effi ciency and effi cacy of a global healthcare system.
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QP • www.qualityprogress.com46
InnovatIon ImperatIve BY Peter Merrill
UnpluggedTechnology’s ties to innovation aren’t as strong as you think
Many people think technology drives
innovation. In fact, the opposite is true.
Innovators may use technology to find
innovative solutions, but the innovation
process is driven by customer needs, not
technology.
Throughout history, the essential
creativity of people has led to incredible
achievements, such as the construction
of the pyramids, the development of the
steam engine and today’s endless digital
applications. It is important to remember
that people developed technology, and
the true genius behind these techno-
logical breakthroughs is often buried in
history.
Too frequently, a self-promoting indi-
vidual takes the credit. The invention of
the light bulb is an example. In truth, most
technological breakthroughs result from
collective knowledge or group genius.
Breakthroughs are the result of the
continual bouncing of ideas between
people. The media love to credit one
person because the story loses its impact
if credit is shared. The reality is that we
are gregarious animals, and the lone in-
novator is an attractive myth but a rare
occurrence. It is through teamwork and
networking that we arrive at many of
our best solutions. The innovative leader
pulls together that group genius.
Suppressing imaginationIronically, creativity—a natural compo-
nent of our being—has been suppressed
by the brave new world of technology
because technological solutions are often
underdeveloped. The shortcomings of a
piece of equipment or, more commonly to-
day, a piece of software are then overcome
by user workarounds.
My first summer vacation job was in a
bakery. My first task was to stand at the
end of a conveyor belt and transfer the
dough coming off one belt to another—a
mind-numbing task and the result of a
failure to fully develop the equipment.
I was a cog in the machine, and the
experience of my mind being numbed
and shrunk made me think, “This is how
revolutions start.”
Everyone has used software with an
appallingly difficult interface. The worst
example of this for me was software with
the ironic name “Concur.” The devel-
oper produced something that actually
required the use of a fax machine for the
software to fully function. I don’t think
anyone would concur with the manufac-
turer’s design of a product requiring that
much additional legwork.
Another deficiency that always annoys
me is the ridiculous software keyholes
through which you need to post thou-
sands of words of information to use soft-
ware. People who produce such failures
clearly lack an understanding of technol-
ogy’s application in the modern world.
So why must we deal with these tech-
nological failures? Usually, it’s because
we do not have a well-managed innova-
tion process, and the process that does
exist does not fit with the organization.
Two phasesThe innovation process has a creative
phase in which people find conceptual so-
lutions and an execution phase in which
those solutions are developed and made
to be more user friendly.
The creative phase requires an open
mind that creates lots of ideas. The exe-
cution phase requires focus and diligence
to create a working solution. As Thomas
Edison said, “Genius is 1% inspiration,
99% perspiration.”1
One of the biggest obstacles for an
organization delivering new technology
is caused by failing to structure itself so
it can create and deliver. We pair product
research and development for short-term
convenience.
Organizationally, we should pair market
March 2012 • QP 47
research and product research. This is the
creative work. Then, we should pair devel-
opment and delivery to make the solution
work in the user environment.
The common bond in the creative
phase is research. But the market re-
searcher and scientific researcher some-
times struggle to work together because
market research focuses more on people
and their behavior, and scientific research
focuses on the product and its behavior.
A successful organization encourages
this diversity and recognizes it is the
spark of genius. Breakthroughs occur at
the intersection of the bodies of knowl-
edge and in clashes of cultural diversity.
The marketers and scientists in this cre-
ative phase need the same work environ-
ment, so this is a feasible setup.
Both groups need space. They need
open networks in which they can interact
with diverse people. They need to behave
in similar ways. In both cases, explora-
tion, collaboration and experimentation
are essential behaviors.
Often, we give that freedom to the
marketers but fail to give it to the scien-
tists who are confined to a lab and asked
to think inside the box. It’s a foolish
approach because this is usually the low-
budget phase of the innovation process.
Falling shortBut the phase of the innovation process
in which the organization fails to deliver
more often is in the execution phase. The
mission in this phase is to make the new
offering user friendly and get it in the
hands of the user. Behavior in this phase
must be radically different because it
requires high speed and intense focus.
In 2002, Daniel Kahneman earned a
Nobel Prize in economics. Among his
work was a key finding: Developers will
overestimate the value of their new offer-
ing by a factor of three, and end users will
overestimate the value of their existing so-
lution by a factor of three. Multiply the two
numbers, and you get an obstacle of nine
times the value—or a logarithmic increase
in value—for an offering to be accepted.
That’s a major challenge for the devel-
oper of new technology who must under-
stand the end user’s behavior patterns.
Obsession with technological features is
the path to failure.
Developers need to operate in closed
networks that include customers and
suppliers while focusing on building trust
among all parties. An increased sense of
trust leads to more and faster knowledge
sharing.
Developers need the discipline of good
project management, and operations
needs a sound quality management system
to deliver quickly without rework. Ad-
ditionally, the concept work in the creative
phase often produces inadequate data,
which burdens developers with extensive
rework on a flawed concept.
Standard solutionDevelopers can do worse than clause 7.3
in ISO 9001:2008 to remedy this situation.
The discipline of development planning
and review offered by the standard sig-
nificantly strengthens development.
Half-baked solutions reach the mar-
ketplace because of a half-baked review
process. In that situation, interim deci-
sions and the reasons for those decisions
are poorly recorded. Three months after
a decision is made, it is forgotten, and the
project goes into rework mode with the
excuse that the process is “iterative.”
The development review process
also must be hardwired to the manage-
ment review process—clause 5.6 in ISO
9001:2008. The resource needs for the
new offering change constantly in the
execution phase, and resources come
from organizational leadership. Opera-
tions and sales must be closely connected
to product development because it’s their
job to deliver, and their greatest ally will
be advance notice of the new offering.
Many of us have struggled need-
lessly because of new technology that
was poorly developed. By addressing
organizational issues, it’s possible to
deliver innovative technology that doesn’t
frustrate the user. And if your organi-
zation is structured properly, you will
prevent the competition from stealing an
underdeveloped idea—and the potential
customers that idea would bring to your
organization. QP
RefeRence1. the Quotations Page, www.quotationspage.com/
quote/2054.html.
Why must we deal with technological failures? Usually, it’s because we don’t have a well-managed innovation process.
Peter Merrill is president of Quest Management Systems, an innovation consultancy based in Burlington, On-tario. Merrill is the author of several ASQ Quality Press books, including Do it right the Second time, second edi-tion (2009), and innovation Generation (2008). He is a member of ASQ and
the ASQ innovation technical Committee.
QP • www.qualityprogress.com48
Measure For Measure BY JaY L. Bucher
On Solid GroundThe basics behind establishing an effective calibration program
If they don’t have an in-house metrol-
ogy or calibration department, then most
biopharmaceutical and medical-device
organizations assign calibration responsi-
bilities to the lowest-ranking member of
either their quality assurance or facility
services departments.
That’s how it used to be done, but this
is the 21st century, and I hope times have
changed for the better.
A quality calibration program, regard-
less of whether the calibration and repair
of that test equipment is outsourced or
performed in-house, must include a train-
ing program, which is a requirement of
standards from the International Orga-
nization for Standardization (ISO) and
regulations from the U.S. Food and Drug
Administration.
There are a few fundamentals every
calibration or metrology department
should know to get moving in the right
direction. The basic parts of a training
program might include the following
topics:
• Whatthestandardsandregulations
actually say.
• Therealmeaningofcalibrationand
traceability.
• Thefivestepsofaqualitycalibration
program.
• Howtosurviveanauditorinspection.
Two of a kindLet’s start by looking at what the stan-
dards say about calibration requirements.
ISO 9001:2008 and ISO 13485:2003 are
basically identical when it comes to their
requirements:
• Measuringequipmentwillbecalibrated
atspecifiedintervalsagainstmeasure-
ment standards traceable to internation-
al or national measurement standards
(the International System of Units).
• Measuringequipmentwillhaveidentifi-
cation that makes it easy to determine
its calibration status (calibration labels
or stickers).
• Adjustmentscannotbemadetothe
equipment after calibration has been
performed (labels indicate that calibra-
tion is void if seal is broken).
• Therewillbeanassessmentand
records kept for the validity of the
previous measuring results when the
equipment is found to be out of toler-
ance (an out-of-tolerance program).
• Appropriateactionwillbetakenif
the equipment is found to be out of
tolerance, as well as any subsequent
equipment that is also affected.
• Calibrationrecordswillbemain-
tained.1, 2
The regulations state the same thing
but in more detail and are not voluntary
when it comes to compliance. The require-
mentsfrompart820.72oftheCodeof
Federal Regulations Title 21 cover the
requirements in the greatest detail by stat-
ing the following:
• Eachmanufacturershallestablishand
maintain procedures to ensure equip-
ment is routinely calibrated, inspected,
checked and maintained. The pro-
cedures shall include provisions for
handling, preservation and storage of
equipmentsoitsaccuracyandfitness
for use are maintained. These activities
shall be documented.
• Calibrationproceduresshallinclude
specificdirectionsandlimitsforac-
curacyandprecision.Whenaccuracy
and precision limits are not met, there
shall be provisions for remedial action
to reestablish the limits and to evaluate
whether there was any adverse effect
on the device’s quality. These activities
shall be documented.
• Calibrationstandardsusedforinspec-
tion, measuring and test equipment
shall be traceable to national or inter-
national standards.
• Regardingcalibrationrecords—includ-
inglabelsandstickers—theequipment
identification,calibrationdates,the
individual performing each calibra-
tion and the next calibration date shall
be documented. These records shall
be displayed on or near each piece of
equipment or shall be readily available
to the personnel using such equipment
and to the individuals responsible for
calibrating the equipment.3
Standard definitionThenexttaskisdefiningcalibrationand
traceability. These are probably the most
misunderstood words in the calibration
and metrology community, as well as with
auditors and inspectors.
In simplest terms, calibration is the
comparison of two measurement devices
orsystems—oneofknownuncertainty
(your standard) and one of unknown
uncertainty (your test equipment).
Traceability is the property of the result
of a measurement or the value of a standard
that can be related to stated references,
usually national or international standards,
through a documented unbroken chain of
calibrations—thepapertrail—allhaving
stated uncertainties, and each contributing
to the measurement uncertainty.
Both require the documentation or
displayofuncertainties.Withoutthatdata,
there can be no calibration or traceability.
March 2012 • QP 49
Examplesofmythsconcerningthesetwo
definitionsinclude:
You cannot calibrate a glass
thermometer because it cannot be
adjusted.
This is false because calibration is a
comparison; it has nothing to do with
adjustmentoralignment.
If the test instrument’s “as found”
readings are within tolerance, calibra-
tion is not required.
Thisisfalse.Everytimeacalibration
is performed, the equipment’s “as found”
readings, as well as those of the stan-
dard it was compared against, must be
recorded.
Calibrations must be traceable to
the National Institute of Standards
and Technology (NIST) in the United
States.
This is false because traceability
should be to a national or international
standard through NIST, a national me-
trology institute or a primary standards
laboratory. Your test equipment does not
need to be traceable to an institution,
but rather to the standards used by that
institution.
Calibration can only be performed
in a controlled environment, such as a
third-party calibration laboratory.
This is incorrect. A controlled environ-
ment is required only when metrics such
as temperature or humidity will have an
effectonthecalibrationresults—usually
highly accurate test equipment used as
reference standards.
Thevastmajorityoftestequipment
used within biopharmaceutical or medical
organizations can be calibrated on site for
traceability using standards that fall under
the four-to-one rule: The uncertainty of the
standard is four times more accurate than
the tolerance of the item being calibrated.
Gimme fiveIt’salsoimportanttoknowthefivesteps
of a quality calibration program:
1. Say what you do.Havewritten
procedures in place for all calibra-
tions that need to be performed at your
organization. It’s usually acceptable to
includealignment,adjustmentandrepair
procedures in your calibration procedures
if they are segregated from the actual
calibration portion of the procedure.
Keep in mind that a full calibration
must be performed and all readings re-
corded before performing any alignment,
adjustmentorrepaironthetestinstru-
ment being calibrated.
Also, if a preventive maintenance
inspection(PMI)isgoingtobeperformed
during this timeframe, you must properly
document your calibration readings,
performthePMIandthencalibrateto
ensuretheunitisstillwithinitsspecified
tolerances.
2. Do what you say. Use those proce-
dures every time a calibration is per-
formed.It’snotenoughtojusthavethem
in place; they need to be available and in
usebyyourcalibrationstaff,notjustsit-
ting on the shelf looking pretty.
3. Record what you did. You must
record what your standards are, as well
as what the item being calibrated read,
beforeandafteranyadjustmentoralign-
ment is made. That record must be kept
for a predetermined amount of time and
made available during audits or inspec-
tions.
This is one of the many reasons to
have a paperless record system for your
calibration department; it’s much easier to
be able to access the appropriate calibra-
tion record on a computer than to travel
toaspecificlocation,searchthroughfiling
cabinetstofindtherecordtheinspec-
tor has required, and then hunt through
anotherfilingcabinettolocatethecalibra-
tion records for the standards used for
that calibration.
4. Check the results. Did the item
being calibrated pass or fail?
5. Act on the difference. If the item
failedtomeetthespecifiedtolerances,
whathappened?Wasanassessmentper-
formed on the test equipment or product
affectedbythefaileditem?Wasallof
this documented according to the written
procedures you must have in place?
Brass tacksThis is an extremely high-level view of the
fivestepsofaqualitycalibrationprogram.
I’ve written entire books on this concept,
going into great detail on each step and
howtheycoverthespecificrequirements
of ISO standards and FDA regulations.
The bottom line is this: Do you have a
program in place that covers these topics
to the satisfaction of your auditors or
inspectors for the standards or regulations
that govern your organization?
It makes no difference whether you
use the same terminology I do. But if the
quality of the product going to customers
is positively affected by a quality calibra-
tion program, you can call it anything you
desire. If your program has a negative
impact on product quality, you should
reassess your calibration program.
Thefinaltopicyoushouldcoverinyour
training program is surviving an audit or
inspection. For tips on that, take a look at
mylastMeasureforMeasurecolumn.4 QP
RefeRences1. International Organization for Standardization, ISO
9001:2008—Quality management system—Requirements.2. International Organization for Standardization, ISO
13485:2003—Medical devices—Quality management systems—Requirements for regulatory purposes.
3. u.S. Food and Drug administration, “code of Federal regulations Title 21,” www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=820.
4. Jay L. Bucher, “under the Microscope,” Quality Progress, September 2011, pp. 54-56.
Jay L. BucheR is president of Bucherview Metrology Services LLc in DeForest, WI. he is the author of The Quality calibration handbook and a Paperless calibration Department That Meets Biotech, Pharmaceutical and Medical Device requirements. Bucher is a senior member of aSQ,
the secretary of the Measurement Quality Division and a certified calibration technician.
StatiSticS Roundtable BY Christine Anderson-Cook
Right answer, Wrong QueryEnsure experiments are designed to address the problem at hand
50 QP • www.qualityprogress.com
Recently, I was reminded of one of
my favorite statistics-related quotes from
John W. Tukey: “Far better an approxi-
mate answer to the right question, which
is often vague, than an exact answer to
the wrong question, which can always be
made precise.”1
I had just encountered an experimenter
with whom I had worked in the past,
and he was excited to tell me about an
experiment he had run using software to
generate an optimal design. What could be
better than that?
It eventually came to light that he didn’t
know what criterion had been used: Was
this a best design for good estimation of
model parameters or good prediction of
new observations? On what model was the
optimization based?
That brings us to a broader issue re-
lated to solving the right problem. One of
the core tenets of statistical engineering2,3
is focusing on defining the problem cor-
rectly. Choosing the right problem to solve
and selecting the right path to the solution
are enormously important to the success
of the project.
At one time or another, I’m sure we’ve
all been associated with a project for
which we obtain an elegant and pleasing
solution, only to find out later it did not ap-
ply to the actual situation for which it had
been designed.
As statisticians, an excellent role to
play is as “askers of many questions.”4 This
can have a powerful impact on under-
standing, and not taking assumptions and
starting points for granted.
George Heilmeier developed a helpful
list of questions to find the right focus for
research efforts.5 The list of nine ques-
tions, shown in Table 1, have been adapted
by the NASA Langley Statistical Engineer-
ing group as the core method for triaging
and providing appropriate focus for new
projects. These questions force us to
identify:
• Precisely what we want to do.
• An important, well-
defined question worthy
of the resources that will be
spent to find the answer.
• Areas where we
might get into trouble.
On the surface,
the questions seem
straightforward and
almost obvious, but giv-
ing a quality precise answer
requires deep thought.
The NASA group has augmented
these with questions such as “How
well do you need to know?” and “What
are the consequences if you are wrong?”
to delve into the aspect of prediction and
estimation variance, as well as the power
to guide sample size issues. All these ques-
tions are important for problem selection,
quality of solution and being able to com-
municate the importance of the project to
others.
Constructing a designReturning to my friend who had run the
experiment, he had been fooled by the
label of “optimal” and had jumped in too
quickly before sorting out precisely what
the goal of the experiment was. As I have
previously noted, a good design is rarely
as simple as optimizing over a single
objective.6
Historically, the choice of designed
experiments relied heavily on classical
designs that were quite general, had good
properties for a wide range of applications
and often were designed to take into ac-
count several measures of a good design.7
With the advent of readily available
computer power, there has been a strong
movement toward optimal designs, which
selects a single objective and finds the
best design possible based on that. The
singularity of purpose of these computer-
generated designs have sometimes left
experimenters vulnerable to model mis-
specification when slight changes occur
with the scenario, or there are problems
with data collection.
Most recently, there has been a move-
ment to consider multiple objectives
when constructing a design. All of this is
predicated on thinking hard about what
the goals of the experiment are, where
things might go wrong and what repre-
sents a successful outcome. This is a
key message: Don’t solve the convenient
March 2012 • QP 51
problem. Solve the actual problem.
There are many experiments for which
the goals are quite similar: Estimate a
particular model—with some ability to
assess the assumptions of the model—and
continue to provide unbiased information
in the presence of some model misspecifi-
cation.8
But what should experimenters do if
they have a nonstandard problem?
1. Identify the objectives of the
experiment. What is really important for
the success of the data collection?
2. Find metrics or quantitative
criteria that capture the essence of
what is important. It is helpful to re-
member what a metric or statistic should
do: “A real statistic measures something
useful, not just something that is easy
to measure. In this sense, it must have
predictive value, which is the acid test
of any statistic. If what you are really
trying to measure can’t be measured by
your methods, you need to improve your
methods, not measure something else
that is less relevant.”9
The predictive value we seek in
design-of-experiment problems is good
performance based on our priorities of
the study when the data are collected.
3. After the metrics of interest
have been defined, find an experi-
ment that satisfies these priorities.
There are several strategies for translat-
ing multiple objectives into a tractable
optimization problem. One established
approach that works well—if you have
precise knowledge about how to weight
the different objectives—is a desirability
function.10
Pareto preferenceAnother approach that allows for impre-
cise knowledge of the relative importance
of the different criteria and exploration
of robustness uses Pareto fronts.11 This
approach also allows you to examine po-
tential different designs to understand the
trade-offs between the often-competing
objectives.
The key feature of these approaches is
they include the flexibility to specify the
problem the experimenter is really inter-
ested in solving, not just a “close-enough”
approximation with a readily available
solution.
The goal should be a precise answer to
the right question. If both are not possible,
then focusing on the right question should
trump the precision of the answer.
Peter Drucker summarized the take-
home message: “The most serious mis-
takes are not made as a result of wrong
answers. The truly dangerous thing is
asking the wrong questions.”12
As early as 1957, A.W. Kimball chal-
lenged applied statisticians to avoid
“errors of the third kind,” which is defined
as giving the right answer to the wrong
question.13 Investing in understanding and
articulating the key aspects of a study can
lead to vastly improved results and impor-
tant prioritization of how to best spend
resources. QP
ReFeRences anD nOte1. John W. tukey, “sunset salvo,” The American Statistician,
Vol. 40, no. 1, 1986, pp. 72-76.2. roger W. hoerl and ronald d. snee, “Closing the Gap,”
Quality Progress, May 2010, pp. 52-53.3. Christine M. Anderson-Cook, Lu Lu, Gordon Clark,
stephanie P. dehart, roger W. hoerl, Bradley Jones, r. Jock Mackay, douglas C. Montgomery, Peter A. Parker, James simpson, ronald d. snee, stefan steiner, Jennifer Van Mullekom, G. Geoff Vining and Alyson G. Wilson, “statistical engineering—Forming the Foundations” Quality Engineer-ing, Vol. 24, no. 2, March/April 2012.
4. William G. hunter, “the Practice of statistics: the real World is an idea Whose time has Come,” The American Statistician, Vol. 35, 1981, pp. 72-76.
5. Joshua shapiro, “George h. heilmeier,” IEEE Spectrum, Vol. 31, 1994, pp. 56-59.
6. Christine M. Anderson-Cook, “A Matter of trust,” Quality Progress, March 2010, pp. 56-58.
7. raymond h. Myers, douglas C. Montgomery and Christine M. Anderson-Cook, Response Surface Methodology, third edition, Wiley, 2009, p. 282.
8. Bradley Jones and Christopher J. nachtsheim, “A Class of three-Level designs for definitive screening in the Pres-ence of second-order effects,” Journal of Quality Technol-ogy, Vol. 43, 2011, pp. 1-15. this article shows a flexible class of screening designs that solve this problem well.
9. Jeffrey Ma, The House Advantage, Palgrave Macmillan, 2010, p. 116.
10. George derringer and ronald suich, “simultaneous opti-mization of several response Variables,” Journal of Quality Technology, Vol. 12, 1980, pp. 214-219.
11. Lu Lu, Christine M. Anderson-Cook and timothy J. rob-inson, “optimization of designed experiments Based on Multiple Criteria Utilizing a Pareto Frontier,” Technometrics, Vol. 53, 2011, pp. 353-365.
12. Peter F. drucker, Men, Ideas and Politics, harvard Busi-ness review Press, 2010.
13. A.W. kimball, “errors of the third kind in statistical Con-sulting,” Journal of the American Statistical Association, Vol. 68, 1957, pp. 133-142.
CHRISTINE M. ANDERSON-COOK is a research scientist at Los Alamos Na-tional Laboratory in Los Alamos, NM. She earned a doctorate in statistics from the University of Waterloo in Ontario. Anderson-Cook is a fellow of both the American Statistical Associa-tion and ASQ.
1. What are you trying to do? Articulate your objectives using absolutely no jargon. What is the problem? Why is it hard?
2. How is it done today, and what are the limits of current practice?
3. What’s new in your approach, and why do you think it will be successful?
4. Who cares?
5. If you're successful, what difference will it make? What impact will success have? How will it be measured?
6. What are the risks and the payoffs?
7. How much will it cost?
8. How long will it take?
9. What are the midterm and final exams to check for success? How will progress be measured?
critical questions for research proposals / TAble 1
QP • www.qualityprogress.com52
StandardS OutlOOk BY Les schnoLL
Complex Relationship The evolving role of the regulatory professional
As orgAnizAtions regulated by the
U.S. Food and Drug Administration have
grown and the desire to market their
products globally has increased, it is criti-
cal for regulatory professionals to keep up
with that demand.
You may think this is a relatively simple
process, but the constraints and road-
blocks set by organizations make it more
difficult than it needs to be.
In addition to being required to master
a multitude of global requirements, regula-
tory professionals must address other
issues that impede their ability to function
expeditiously, including:
• Gettingcaughtbetweenarockanda
hard place—the organization vs. the
regulatory body.
• Notknowingthelinebetweenconfor-
mance and nonconformance.
• Beingperceivedasaroadblockor
impediment to progress.
• Lackingbroadknowledgeofmanage-
ment.
• Workinginaroleatypicalofthecore
executive strategic pathway.
• Beingunabletodealcomfortablywith
gray areas.
• Fightingtheperceptionthattheirdeci-
sions are made in a regulatory vacuum.
• Workingfororganizationsthatdon’t
speak the language of regulators.
• Beingaccusedofdividedloyalties—the
organization vs. the regulatory body.
• Havinglowvisibility.
• Havingdifficultymanagingexpectations.
• Needingtoconstantlylegitimizetheir
role.
• Sufferingfromprofessionalidentity
crisis.
• Fightingtheperceptiontheirroleisnot
a value-add.
• Beingaccusedofregulatory“decision
shopping.”
• Dealingwithanincreasinglyglobal
business environment, multiple regula-
tory agencies and external forces, such
as trade associations, litigators and
customers.
• Notbeingperceivedasastrategicbusi-
ness partner.
Howcanaregulatoryprofessional
address these issues while best serving all
stakeholders? For starters, they need to
assess the current situation and determine
what can be changed, including:
• Theircommunicationwiththeorgani-
zation (not speaking only the language
of regulations).
• Personalrelationshipsandalliances.
• Theirunderstandingoftheorganization.
• Howtheymanageconflictresolution.
• Theirvisibilityandcredibility.
• Theirmissionstatementandvision.
• Howtheydevelopandsharetheir
values and beliefs.
The organization also needs to provide
assistance to regulatory professionals by
changing and improving:
• Leadership’sperceptionoftheroleof
regulatory professionals.
• Howotheremployeesareinformedand
educated about the role.
• Therecruitingprocess.
• Theamountofparticipationonteams
within the organization.
Phase shiftAs shown in Figure 1, there are five distinct
phases in the relationship between organi-
zations and regulatory professionals, and
each phase has its own impact on regula-
tory compliance.
In the dissociative phase, the organi-
zation’sobjectivesareminimalintrusion
when it comes to operations, minimal
compliance effort, comprehensive quality
inspection, minimal training costs and the
implementation of superficial processes.
In this environment, the regulatory
Synergistic
Contributionvalue/$Strategic
contribution
Integration with customer strategy/objectives
Interactive
Proactive
Reactive
Dissociative
strategic alignment process overview / figure 1
March 2012 • QP 53
professional’srolehaslittleornoinvolve-
ment in regulatory issues, protecting the
organization from enforcement activities,
using outside counsel when required and
minimizing costs.
Needlesstosay,thesearenotthehall-
marks of a healthy relationship, and the
potential consequences of operating under
this scenario can be disastrous.
In the reactive phase, the organiza-
tion’sobjectivesincludeachievingbasic
compliance, implementing rudimentary
quality assurance or quality control func-
tions, avoiding serious violations, minimiz-
ing costs, implementing basic design con-
trols, meeting basic reporting requirements
and accepting product classification risks.
Theregulatoryprofessional’sroleinthis
phase involves enforcement, identifying
areas of significant noncompliance, mini-
mizing enforcement costs, responding to
inspection findings, managing inspections
with no defined process and defending the
organization when violations occur.
The reactive phase is slightly better
than the dissociative stage, but not by
much.Thenamesaysitall:Beingreactive
isinnoone’sbestinterest.
The proactive stage provides the first
indication the relationship between the or-
ganization and the regulatory professional
is reaching solid ground.
Theorganization’sobjectivesaretoper-
form gap analysis, involve senior manage-
ment, implement an effective regulatory
and quality program, audit for compliance,
conduct training, communicate with regu-
latory agencies, solicit employee input and
demonstrate a cost-benefit advantage.
The pressures on regulatory profession-
als begin to be alleviated, and they can ac-
complish what they were hired to do. The
role now involves understanding regula-
tory requirements, anticipating regulatory
changes, recognizing regulatory issues in
other business processes, advising and
training,protectingtheorganization’sin-
terests during regulatory inspections and
keeping management informed.
Getting closerThe interactive phase is the fourth step
inthejourney.Atthisstage,theorganiza-
tion’sobjectivesinclude:
• Settingqualityandregulatoryobjec-
tives with senior management.
• Involvingdesign,manufacturingand
procurement teams early in the regula-
tory process.
• Communicatingconstantly.
• Exceedingregulatoryagencycompli-
ance standards.
• Achievingcontinuousimprovement.
• Anticipatingchange.
• Focusingonprevention.
In this phase, the regulatory profes-
sional’sroleistobeproactivelyinvolved
with the organization, to understand the or-
ganization’sstrategiesandgoals,tosecure
early involvement from all levels within the
organization, to agree on expectations for
timeliness and quality of output, and to de-
velop a compliance and prevention strategy.
The summit is the synergistic phase.
Whentheorganizationreachesthislevel,
itsobjectivesincludeensuring:
• Qualityisinternalizedatalllevels.
• Theregulatorydepartmentisaligned
with corporate strategies.
• Regulatoryandqualityconsiderations
are the top priority in mergers and
acquisitions.
• Preventioneliminatestheneedfor
quality control inspections.
• Managementviewsregulatoryagencies
as customers.
• Rootcausesofproblemsareidentified
and eliminated.
At this point, regulatory professionals
can breathe a sigh of relief because their
role now involves strategic alignment, trust-
based relationships, early participation in
new product development and mergers and
acquisitions, contracting with the organiza-
tion for performance metrics, and develop-
ing and communicating a risk or opportu-
nityprofile.Now,complianceisviewedasa
value-added activity by the organization.
Hard roadRegulatoryprofessionalsdon’thavean
easyjob.Initiallyfacedwithconstraints
and roadblocks put in place by organiza-
tions, it is almost impossible to perform
thejobexpectedbyallstakeholders,
including regulatory agencies.
As the regulatory environment evolves
within the organization, the role becomes
more palatable, and activities can be ac-
complishedmoreeasily.Buttrueprogress
can’tbemadeuntiltherelationshipreach-
es the interactive and synergistic phases.
Makesureyouassessthestatusof
the organization and determine where it
standsintheevolutionarypyramid.Ifit’s
not in the interactive or synergistic phase,
a plan should be put in place to help move
the organization in the right direction. QP
Les schnoLL is principal of Quality Docs LLc, which provides quality and regulatory consulting services to industries regulated by the U.s. Food and Drug Administration. he earned a doctorate in health law from concord University school of Law in Los Angeles. he is a senior member
of AsQ and an AsQ-certified quality engineer, auditor and manager. A member of the U.s. technical advisory group to Iso 9000 technical committee 176, schnoll wrote The Regula-tory compliance Almanac.
regulatory professionals must address issues that impede their ability to function expeditiously.
QP • www.qualityprogress.com54
Career Corner BY Teresa WhiTacre
MOST OF us will not get a golden para-
chute. But we can create our own version
of a golden parachute in the form a survival
kit—actions we can take to ensure success
at our current job or in finding a new one.
The employment process is a two-way
street. By understanding the basic needs
of an employer or organization, we can
determine how to fulfill our needs at the
same time. How you fill the needs of your
organization is just as important as how
your needs are met in performing work for
your employer.
Remember the basicsWhen thinking about basic needs in your
career, think of Abraham Maslow’s hierarchy
of needs and how it applies to succeeding at
your current job or finding a new one.
In Maslow’s hierarchy, basic needs for
survival include food, shelter, clothing and
warmth, protection, security and stability.
Higher needs are belongingness, personal
growth and fulfillment. Maslow’s theory
illustrates that if we don’t have the basics,
such as food, water and warmth, we can’t
move to the next step.
Keeping ourselves healthy—physically,
mentally, emotionally and spiritually—is
one of the important basic steps in obtain-
ing and maintaining the relationship with
an employer. If you are currently or have
been out of work for an extended period
of time, you know how draining it can
be—physically, emotionally and financially.
Think about what you can do to keep
yourself in top shape. It’s important for
your career.
Impressions are important no matter
when and where they occur. Physical
appearance aside, the way you communi-
cate with those around you is important,
no matter what the situation. Verbal or
written communication, as well as body
language, matter in personal settings.
Often, personal contacts or relationships
lead to professional opportunities.
Create what you wantIt’s tempting and quite common to blame
the economic climate for a lack of employ-
ment opportunities. Rather than blame the
economy, consider the possibility that the
techniques used in a job search don’t work
as well during difficult economic times as
they do during a thriving economy. The
economy is just a factor telling us that our
techniques need to change to meet the
conditions.
Many industries have needs to fill but
often cannot find qualified individuals
who are capable of filling those needs.
You can survive in the job search jungle
by constantly keeping your skills up with
the market. If you haven’t done that lately,
you can still be a survivor. Inventory your
skills and how you can market those skills
to prove you fit the needs of an organiza-
tion. Focus on what you have, not what
you don’t. What can you do, or what have
you done? How can you demonstrate that?
Create what you need or want to replace
what you cannot get. Your survival—
whether related to basic human needs or job
skills—is often up to you. If you cannot find
the employment opportunity you want or
need, then it is time to create your own path.
I speak from experience, having creat-
ed my own path more than once. I applied
for work with organizations, even though
I felt I was better suited for something
other than what they were advertising.
They wouldn’t have known I existed had I
not taken the chance.
Think about
your needs in
terms of an employment
relationship. Are you looking
for a career move? Career advance-
ment? A close commute? Strictly some
income to pay your bills? After you deter-
mine what you need, you can work toward
creating something to fulfill that need.
Excuses and hurdles abound if you let
them get in the way. Think about all the
reasons you allow to stand in the way of
getting what you want: too old, too young,
over or under qualified, over or under edu-
cated, physical appearance, medical history
or financial history.
Your view of yourself affects the image
you portray and how others view you.
Making sure your basic needs are met and
knowing how to use your skills to meet the
needs of the employer will help you survive
in a job search or succeed at the job you
already have. QP
TERESA WHITACRE is a quality as-surance manager in Pittsburgh and a principal in Marketech Systems. She has a bachelor’s degree in organizational management from Ashford University in Clinton, IA, as well as ASQ certifications as a quality auditor, engineer, manager and Six
Sigma Green Belt. Whitacre is the chair for ASQ’s Pittsburgh section, instructor for the section’s certified quality inspec-tor refresher course and deputy regional director for ASQ Region 8. She is an ASQ fellow.
Survival Kit for SuccessAchieve your long-term career goals by fulfilling basic needs
QPcalendarapril
2-4 Supply Chain World North amer-
ica. Miami. call the Supply chain council at
202-962-0440 or visit www.supply-chain.org.
7-May 5 lean Six Sigma and
Green Belt Training and Certification.
Southfield, MI. call SYBeQ: Systems for Bet-
ter Quality at 248-233-6104 or visit www.
sybeq.com.
9-13 Strategic Marketing Manage-
ment. chicago. call the University of
chicago Booth School of Business at
312-464-8732 or email exec.ed@
chicagobooth.edu.
16-18 The Quest for Excellence
Conference. Washington, d.c. Visit
the national Institute of Standards and
Technology at www.nist.gov/baldrige/qe/
index.cfm.
18-23 The performance improve-
ment Conference. Toronto. Visit the
International Society for Performance
Improvement at www.ispi.org.
aSQlearnInGInSTITUTe UpCOMiNG ClaSSrOOM-BaSEd TraiNiNG
aprilGreenville, SC
16-17 16-hour ISO 9001:2008 lead auditor Training (raBQSa certified)
16-17 lean for Service
16-18 root cause analysis
16-20 Black Belt/Quality engineering Statistics
16-20 ISO 13485 lead auditor Training (raBQSa certified)
16-20 ISO 22000:2005 lead auditor Training (raBQSa certified)
16-20 ISO/Iec 17025 lead assessor Training
18-20 Implementing and auditing an ISO 9001:2008 Quality System
19-20 Measuring Process and Organizational Performance
MayMilwaukee
7-8 certified Quality auditor certification Preparation
7-9 Internal auditor Training for aS9100
7-10 Guide to Process Improvement and change
7-11 certified Quality engineer certification Preparation
7-11 Introduction to Quality Management
7-11 ISO 9001:2008 lead auditor Training (raBQSa certified)
7-11 Software Quality engineering
9-10 Systematic Problem Solving for Sustained Improvements With Quality
10-11 customer Supplier Partnerships—an Introduction
10-11 16-hour ISO 9001:2008 lead auditor Training (raBQSa certified)
ViSiT WWW.aSQ.OrG/lEarNiNGiNSTiTUTE FOr dETailS.
March 2012 • QP 55
23-24 Essentials of Strategic
alliances and partnerships. new York. Visit
the american Management association at
www.amanet.org.
26-28 deming 3-day Workshop.
austin, TX. For more information, visit the
aSQ austin website at http://asqaustin.
org/?p=1886.
30-May 4 Shingo prize inter-
national Conference. Jacksonville, Fl. For
more information, visit http://shingoprize.
org/2012conference/index.html.
May
8-10 SME Mfg4 Conference. Hartford,
cT. call the Society of Manufacturing engi-
neers at 800-733-3976 or visit http://www.
mfg4event.com/2012/public/enter.aspx.
21-23 aSQ conference. institute for
Software Excellence. anaheim, ca. Visit
http://asq.org/conferences/institute-for-
software-excellence.
21-23 aSQ conference. Quality in-
stitute for Healthcare. anaheim, ca. Visit
http://qihc.asq.org.
21-23 aSQ conference. World
Conference on Quality and improvement.
anaheim, ca. Visit http://wcqi.asq.org.
If you’d like your event included in QP
Calendar, submit information at least three
months in advance to [email protected].
Non-ASQ organizations may list one event
per issue.
SoftwareHeidenhain has released the latest version
of Quadra-Chek metrology software. The
software provides advanced functionality
for inspection measurement machines,
and allows you to perform 2D and 3D
measuring tasks.
3D-profiling capabilities provide mea-
surement and graphic evaluation of 3D
contours using multi-sensor and tactile
measuring machines. This option, used for
profile measurements, can import a 3D
CAD file and compare it with the actual
measured part.
The software features a part program-
ming support compensation for the ther-
mal behavior of products that experience
shrinkage or growth of material during the
manufacturing process. This allows you
to write a single inspection program for
measuring.
Improvements also were added to cur-
rently existing radial and palletize methods
of automatic part programming routines.
These methods help users when there
are common features or parts that repeat
angularly, around a datum, or based on a
palletized grid layout.
• Call:847-490-1191.
• Visit:www.heidenhain.us.
Helmet3M has designed an ergonomic line of
hard hats and helmets made with SABIC’s
innovative plastics business’ lightweight
Xenoy and Lexan optical quality resins.
The3MVersafloM-seriesrespiratory
headgear uses custom-colored Xenoy
polycarbonate/polybutylene terephthalate
resin for headgear shells and visor frames.
Water-clear Lexan is used for the visors
and provides optical quality and high-
impact resistance.
The3MVersafloM-serieshardhats
and helmets are designed for protection
in workplaces such as foundries, automo-
tive refinishing facilities, chemical plants
and construction sites.
• Call:413-448-7795.
• Visit:www.sabic-ip.com.
Linear position sensorsTurck’s Q-track family of linear position
sensorsnowincludestheQR14andQ17
models. The compact, non-contact induc-
tive sensors deliver repeatable measure-
ments in applications with spacing limita-
tions and harsh environments.
Turck’s linear inductive sensor op-
eration is based on the RLC resistance
inductance capacitance principle. Because
the position element does not contain a
magnet, it can be used in metalworking
QP•www.qualityprogress.com56
QPTooLBoX
March2012•QP 57
applications because it will not attract
ferrous debris.
Additionally, the inductively coupled
position element provides non-contact
position feedback ideal for use in ap-
plications with constant motion, such
as pinch rollers, cylinder position, web
tension control, pitch control, resisting
damageandworkshopfloordowntime.
• Call:800-544-7769.
• Visit:www.turck.us.
Moisture quality controlDecagonDevices’AquaLabVaporSorp-
tion Analyzer allows
scientists to better
measure moisture in
products and pinpoint
quality control issues.
The way a product
isinfluencedby
temperature and
humidity changes can
reveal details about
physical and chemical
changes that end
shelf life. This type of measure-
ment is called an isotherm.
Isotherm generation technol-
ogy tracks changes in the amount of
moisture in a product as water activ-
ity changes. Isotherms hold the key to
understanding hidden details of food and
pharmaceutical products.
TheAquaLabVaporSorptionAnalyzer
can provide insight into product develop-
ment, shelf-life estimation, packaging
calculations, temperature abuse model-
ing and component mixing models in
hours instead of weeks.
•Call:800-755-2751.
•Visit:www.aqualab.com.
Configurable counting indicatorCounterpart from Rice Lake
Weighing Systems is a con-
figurable counting indicator
that can convert almost
any scale base into an
intelligent piece-counting
device for parts of every
shape and size. Counter-
part uses a configuration
method to adjust to the parameters and
resolution of an attached scale base. It
also connects with barcode scanners,
label printers and inventory manage-
ment software.
Users can view weight, piece weight,
description and quantity all at the
same time. Counterpart only requires a
10-piecedefaultsample.Italsoprovides
features necessary for better inventory
control and record keeping.
• Call:800-472-6703.
• Visit:www.ricelake.com.
Air-pressure regulatorsMarsh Bellofram has released the Type
41high-performanceair-pressureregula-
tor series, which is designed to support
demanding industrial and original equip-
mentmanufacturingflowmonitoring
requirements.
TheType41’sdesignallowsittobe
used as a drop-in replacement for other
manufacturers’ models, particularly in
applicationswherehigh-flowcapac-
ity,lowdroopathighflow,repeatable
accuracy, fine adjustment sensitivity or
panel mounting may be required. Typi-
calapplicationsincludeconstantflow
monitoring,loworzero-flowmonitoring,
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QP • www.qualityprogress.com58
Applied Concept Mapping: Capturing, Analyzing, and Organizing Knowledge Brian Moon, Robert Hoffman, Joseph No-
vak and Alberto Cañas, CRC Press, 2011,
380 pp., $59.95 (book).
This book is about
concept discovery
and management,
the internet and a
tool to integrate it
all. This allows for
concept mapping
with a low ceiling
and a high thresh-
old.
Concept mapping implementation
was initiated in corporations around 20
years ago. Novak, the main developer of
concept mapping, was invited by Proctor
and Gamble in 1993 to present his ideas in
the context of an initiative looking for total
quality management tools. This resulted in
innovative work done by its R&D depart-
ment, as described in chapter one. Other
chapters include applications to ecological
management, product design, corporate
education and organizational learning at
the local and national level.
The book is the joint work of 37 authors
organized in three sections:
1. Practitioner’s view.
2. Recent case studies and results.
3. Pushing the boundaries.
This book provides an effective
introduction to concept mapping, which
is today even more relevant than it was
when it was first introduced. The book
is well-integrated with a combination of
abstract concepts and real-life examples
making it accessible to newcomers and of
interest to experienced concept mappers.
I highly recommended it to practitioners,
researchers and educators interested in
this topic.
Ron S. Kenett
KPA Ltd.,
Raanana, Israel
Quit Feeding the Monsters J. Kevin Cobb, Two Harbors Press, 2011,
154 pp., $15.95 (book).
This is a short,
straightforward
book that helps
identify some of
the “monsters” we
encounter in our
daily lives. These
are the monsters
that destroy our
motivation or just
plain frustrate us as we try to move for-
ward. The intent of the book is to provide
guidance on how to starve the monsters,
meaning we no longer need to contend
with the issues or results brought about by
their actions.
Each monster is showcased in an anec-
dote from Cobb’s experience by recount-
ing its general characteristics or mode of
operation. Suggestions are then made on
how to deprive it of future nourishment.
Sometimes his corrective actions worked,
and sometimes they didn’t—that’s the
way of the real world. But the loss of a
single battle shouldn’t end the war in most
cases.
Readers who are looking for a simple
way to see where problems exist or a
prescription for how to make improve-
ments will not be satisfied with this book.
People who benefit from teaching by
storytelling will enjoy this book and get
the most from its commentary.
The types of problems that are illus-
trated are the softer, more subtle people
issues that aren’t usually discovered by
data analysis or traditional quality tools.
Monsters can affect quality in the
workplace. Fortunately, the remedies are
not difficult or expensive; they just take
discipline, will and perseverance to imple-
ment.
Marc A. Feldman
Solvay Chemicals Inc.
Houston
Sustainable Business & Industry: Designing and Operating for Social and Environmental Responsibility Joseph Jacobsen, Quality Press, 2011, 216
pp., $50 member, $85 list (book).
Social responsibility
has become a topic
of growing impor-
tance and interest
with the release of
the standard ISO
26000. This book is
timely and provides
insights for those
who want to find more on this topic or
who have been tasked with its manage-
ment in their organization.
Jacobsen discusses a broad range of
social responsibility and environmental
management issues. He sets the stage
by addressing historical context, global
warming, ecological footprints and the
meaning of sustainability itself. He briefly
discusses the connections to quality, such
as the teachings of W. Edwards Deming
and Joseph Juran, as well as, ISO 9001,
ISO 14001, ISO 26000 and lean. Project
QPREvIEWS
management, measurement, plant opera-
tions and a sustainable economy are all
discussed in detail.
The book includes an appendix with an
outline of the fundamentals of statistics
and a useful survey instrument. These
support materials help even those with a
limited science or engineering background
gain better insight into the topics ad-
dressed in the text.
The book provides an engaging, value-
added website link to a lecture on each
chapter and appendix. And by contacting
the author or ASQ, readers can obtain
tests for each of the book’s chapters,
which are ideal for classes and courses.
Denis Leonard
Business Excellence Consulting
Bozeman, MT
Project Management for Healthcare Information TechnologyScott Coplan and David Masuda, McGraw-
Hill, 2011, 288 pp., $70 (book).
This book takes the
synergy that exists
among project
management, IT
and change man-
agement disci-
plines, and shows
how they can be
used to manage the
crisis associated
with access to cost-effective and qual-
ity healthcare. The introductory chapter
highlights several current strategic and
operational challenges healthcare delivery
organizations face. It then discusses how
the application of the book’s method will
increase the rate of success for healthcare
IT-based projects, which can help end the
healthcare crisis.
In chapter 2, Coplan and Masuda briefly
describe and define various components
within each of the three disciplines and
their relationship to project management
process groups that occur during the
project lifecycle.
In the remaining chapters, each disci-
pline is explored in detail in terms of their
respective knowledge areas, supporting
processes and analysis of the outputs from
each process as they occur within the five
project management process groups.
Each chapter includes testimonials
from healthcare IT project leaders on the
important role the proposed integrated
approach played in the success of their
projects. These testimonials and the les-
sons learned shared by these individuals
are critical components of the book.
The authors have done a great job of
introducing the materials in a concise
and organized manner. I considered the
supplemental information—a companion
website, a syllabus for instructors and a
PowerPoint presentation—to be highly
valuable. The only thing missing was the
authors’ final words of wisdom and recom-
mendations on the implementation of the
integrated system.
Herzl Marouni
ABS Consulting
Houston
RECEnT RElEASES
Six Sigma Green Belt, Round 2
Tracy C. Owens, ASQ Quality Press, 2011,
160 pp., $30 member, $50 list (book).
Six Sigma for SustainabilityTom McCarty, Michael Jordan and Daniel
Probst, McGraw-Hill, 2011, 304 pp., $50
(book).
lean Six Sigma for the Healthcare EnterpriseSandra Furterer, CRC Press, 2011. 331 pp.,
$79.95 (book)
March 2012 • QP 59
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Branch OutTry a decision tree to select the right discrete distribution
IT CAN BE DIFFICULT to identify the ap-
propriate discrete distribution to use when
attempting to determine probabilities in a
particular situation.
Whether in real life or for exam pur-
poses (such as for the certified quality en-
gineer exam), the decision tree in Figure
1 can help you determine the appropriate
distribution.
Let’s use the following sample test ques-
tions to demonstrate the use of the deci-
sion tree:
Question one: A process is producing
material that is 40% nonconforming. Four
pieces are selected at random for inspec-
tion. What is the probability of exactly one
good piece being found in the sample?
Solution: Here, we have count data
(the number of good pieces), and for each
piece, there are two outcomes (conform-
ing and nonconforming). We also have
independent trials—that is, four pieces se-
lected at random from a large population,
and there is a fixed number of trials (four
pieces selected). This indicates we have a
binomial distribution.
Question two: Suppose six bad parts
get mixed up with nine good parts. If two
parts are drawn simultaneously, what is the
probability both are good?
Solution: Here, we have count data
(the number of good parts), and for each
part, there are two outcomes (good and
bad). We also have dependent trials—that
is, a small set of parts, and the second draw
depends on the first. This indicates we
have a hypergeometric distribution.
Question three: An inspection plan is
set up to randomly sample three feet of a
100-foot cable and accept the cable if there
are no flaws found in the three-foot length.
What is the probability a cable with an av-
erage of one flaw per foot will be rejected
by the plan?
Solution: Here, we have count data
(the number of flaws). We are counting
the number of occurrences per unit (flaws
per three feet of cable length), and the oc-
currences are independent—that is, one
occurrence does not influence the next oc-
currence. This indicates we have a Poisson
distribution.
Question four: In a certain manufac-
turing process, it is known that an average
of one in every 100 items is nonconform-
ing. What is the probability the fifth item
inspected is the first nonconforming item
found?
Solution: Here, we have count data
(the number of items inspected), and there
are two outcomes per item (conforming
and nonconforming). We also have inde-
pendent trials—that is, items selected at
random from a large population—and an
unknown number of trials that continue
until a nonconforming item is found. This
indicates we have a geometric distribution.
Question five: Suppose that 60% of the
parts produced by a particular machine are
acceptable, 30% need to be reworked to be
acceptable, and 10% are unacceptable and
will be scrapped. What is the probability
that among 15 parts randomly selected for
audit, nine are acceptable, three will need
to be reworked, and three are scrapped?
Solution: Here we have count data
(number of parts produced), and there are
more than two outcomes per trial (accept-
able, reworked and scrapped). We also
have independent trials—that is, parts se-
lected at random from large population.
This indicates we have a multinomial dis-
tribution.
Improving proficiency, accuracyAs these examples demonstrate, with a
little practice, you can become proficient
at interpreting the test questions involv-
ing discrete distributions. The use of the
decision tree can optimize test time and
improve the accuracy of the answers. QP
EDWIN G. LANDAUER is a retired professional engineer and college instructor. He has master’s degrees in industrial engineering from the University of Central Florida in Orlando, in statistics from Montana State University in Bozeman, and in mathematics from Portland State
University in Oregon. Landauer is an ASQ fellow and an ASQ-certified quality engineer.
One GOOd Idea BY EDWIN G. LANDAUER
Decision tree example / fIGure 1
Number ofoccurences
per unit
Count data
More than twooutcomes
Two outcomes
Independenttrials
Dependenttrials
Independenttrials
Independentoccurrences
Fixed numberof trials
Unknownnumber of trials
Multinomialdistribution
Hypergeometricdistribution
Binomialdistribution
Geometricdistribution
Poissondistribution
March 2012 • QP 63
QP • www.qualityprogress.com64
Understanding Variation Analyzing cause to implement corrective action
ORGANIZATIONS WITH quality manage-
ment systems compliant to ISO 9001:2008
are required to take action to eliminate the
causes of nonconformities. Clause 8.5.2
defines steps required for corrective action
(CA), including determination of the non-
conformity cause, along with determination
and implementation of necessary action to
prevent recurrence. Similar wording is also
present in clause 8.5.3 regarding preventive
action (PA).
A cause of a nonconformance should co-
incide with a variation occurrence. With re-
gard to this variation, is its source common
cause or special cause? This question must be
answered for proper cause identification be-
cause the answers may yield different result-
ing paths for CA. Determination of variabil-
ity type is often absent from problem-solving
methods, leading to ineffective actions.
An example explains the two types of
causes of variation:
1. Common cause: It normally takes me
25-35 minutes to commute to a neighbor-
ing town. Note that it does not take me
exactly 31.5 minutes each
time because there
is attribution of com-
mon cause variation.
The value in the
range could be
affected by
factors such as
the number of
red lights I hit,
traffic volume or
weather condi-
tions, such as rain or
sun. These are a normal part of the drive.
Expected common cause variation may
be predicted by a control chart, often
with limits of the mean +/-3 standard
deviations. Common cause variation is
present in every process.
2. Special cause: One day, I arrive at the
town in two hours, which is statistically
peculiar. There is a special cause associ-
ated with this incident that is outside the
normal system: On that day, a blizzard
contributed to the delay.
Address the causeTo solve a problem with a special cause, the
team should be looking for what changed or
is different, whereas solving problems attrib-
uted to common cause will require reducing
the variance, increasing the spec range or
shifting the process mean. All of these relate
to not what is different, but rather what is the
same (intrinsic) in the process.
It is difficult to create an effective
solution if the problem and its cause are
not accurately understood. CA teams can
spend a lot of time solving a problem, only
to have it recur because the team treated a
common cause as a special cause.
To demonstrate the effects of common
cause, consider a pizza shop in my hometown
that includes the neighboring town in the
earlier example in its delivery area. This pizza
company guarantees delivery within 45 min-
utes or the pizza is free. It takes the shop 15
minutes to prepare the pizza. Then, the driver
takes 25-35 minutes to drive to the neighbor-
ing town due to common cause variation.
This results in a total delivery time of 40-50
minutes. At this rate, the driver is on track to
give away 50% of deliveries to that town.
Should the manager be giving the driver
grief for a system that is incapable due to
common cause variation? Perhaps the man-
ager could focus more on the 15 minutes of
preparation time. He or she may have more
influence over the sources of variation in the
store to reduce the process mean. Or, the
manager could change the scope of the spec
by removing the neighboring town from the
delivery area.
Fix the systemMost causes are system problems that
should have system solutions. If an operator
makes a mistake, something in the system al-
lowed the mistake to occur or go undetected.
Instead of engaging the system, a common
response by CA teams in this situation may
be to retrain the operator.
The operator’s performance may be out-
side the range of other employees, implying
an outlier, but what if the training itself is
ineffective? Why retrain with faulty train-
ing? Why was the training ineffective the
first time? Is there an aspect of the training
that needs to be changed?
I wouldn’t consider “employee was
retrained” to be a CA. If this is not a man-
agement issue—such as a blatantly defiant
employee—something in the system needs
modification. Correspondingly, each CA or
PA should have some system documenta-
tion change as a part of the record.
As all of these examples illustrate, deter-
mining the variability type—special cause
or common cause—in root cause methods
will lead to more effective CA and PA ap-
proaches within an organization. QP
BIBlIOGRApHyW. Edwards Deming, Out of the Crisis, MIT Center for Ad-
vanced Educational Services, 1992.International Organization for Standardization, ISO
9001:2008—Quality management systems.
JONATHAN D. PORT is an owner of Bea-con Quality Services LLC in Fort Collins, CO. Port earned a bachelor’s degree in engineering management from the Mis-souri University of Science and Technol-ogy in Rolla. He is a senior member of ASQ and an ASQ-certified Six Sigma Black Belt, quality engineer, quality
auditor and manager of quality/organizational excellence.
Back to Basics BY jOnAThAn D. pOrT
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Visit wcqi.asq.org to register and for up-to-date conference information.
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