M AY 2 0 1 7 | Q U A L I T Y P R O G R E S S .

C O M

Upgrading Harness the Is it Time for

Service Power of Lean Six
Quality With Collective Sigma
Gaps Model Knowledge Version 2.0?
page 16 page 44 page 50
| M AY 2 0 1 7

The official publication of ASQ

ROOT CAUSE ANALYSIS

Effective root cause

analysis starts with
a strong hypothesis

SOLID
FOOTING
VOLUME 50 | NUMBER 5
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FEATURES
16 Mind the Gaps 30 Are These the Same?
Using the gap model, an Arizona Be strategic when error proofing
hospital recovered from poor service devices in workflows so you get
quality, improved process efficiencies things right every single time.
and boosted patient satisfaction by Liem Ferryanto
scores.
by Denise M. Kennedy 36 New Tricks for an Old Tool
Introducing marginal risk and the risk
24 Solid Footing sensitive priority number to FMEA.
Incorporating the five virtues of a by Eugene R. Bukowski
good hypothesis will get your root
cause analysis off on the right foot.
by Matthew Barsalou

INSIDE
May 2017
VOLUME 50 NUMBER 5

EXCLUSIVES
at qualityprogress.com

Experience More
An additional sidebar, as well as more
figures and tables, to illustrate this months
Career Coach (Are You Experienced?
pp. 47-49).

Reaction Gauge
Weigh in on this months question of the
month.

News and Updates

Check Quality News Today for the latest
quality-related headlines.

qualityprogress.com May 2017 QP 3

INSIDE
May 2017

7 8 47 58

6 Seen and Heard 44 Innovation Imperative 64 Back to Basics

Finding alternative answers Passing along past lessons for the
7 Expert Answers throughout collective knowledge. future.
Advantages of an auditing
certification. 47 Career Coach
Assessing your career with the help
8 Progress Report of a modified Ishikawa diagram.
Challenges around chip card
technology. 50 Statistics Spotlight
PLUS Lean Six Sigma version 2.0?
Getting to Know Charles C.
Roberts 54 Standard Issues
Integrate your management systems
9 Mr. Pareto Head while transitioning to ISO 9001:2015.

12 Field Notes 58 Marketplace

Making sense of medical device risk
management. 60 Footnotes
60

Director of Knowledge and
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@ASQ_Seiche
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4 QP May 2017 qualityprogress.com

FOREWORD
The quality inside Quality Progress

Close the Gaps

another feature article in
this months edition. Solid
Footing (p. 24) offers advice
on one way to jump-start your
root cause analysis (RCA):
Incorporate conservatism,
No matter what side of the Affordable Care Act you stand on, modesty, simplicity, generality and refutability when formulating
you can probably agree to this: Everyone seems to be spend- a good hypothesis.
ing more of their own money on medical care these days. A hypothesis that fulfills all of these virtues would be simple,
And when people spend more of their hard-earned paychecks general and make few assumptions, and it shouldnt contradict
on somethingdoctor visits, airline tickets, you name itthey pay what is already known to be true, wrote Matthew Barsalou, who
more attention to what theyre getting in return, and naturally, it seems has become QPs unofficial resident RCA expert. It also
they usually expect more. should be possible to test the hypothesis.
Thats what the Mayo Clinic Arizona faced: services falling short of Still, this doesnt guarantee that a hypothesis is correct, he
patient expectations. So, as an organization that provides a service, explained. Proper application of these virtues can lead to a more
how do you ensure you set reasonable expectationsand meet robust hypothesis that can push the analysis forward and pro-
themto satisfy your customers and keep them coming back? vide the RCA investigator a starting point for the investigation.
Patients are apt to shop for services more discriminately, using A worthwhile reminder for us allwhatever the situation
publicly available data to choose organizations with the best qual- about the importance of building in sufficient time to step back
ity and patient satisfaction scores, wrote Denise M. Kennedy, the and prepare before a needless rush to
author of Mind the Gaps (p. 16). Healthcare organizations must judgment that could push matters in the
improve service quality. wrong direction.
Using the gaps model, managers did just that and improved
customer satisfaction scores by being better at identifying, cate-
gorizing and analyzing the likely causes of poor healthcare quality
and making the necessary changes to close the gaps. Mark Edmund
A better way to pinpoint root causes is the centerpiece of Associate Editor

TCC Heather Crawford, Apollo Endosurgery Administrative Committee

ASQs 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.
ASQ Administration
CEO William J. Troy
Senior Leadership
Andrew Baines
Kalleen Bruch
Dick Palmersheim
Shontra Powell
Chair Eric Hayler, BMW Manufacturing
Chair-Elect Elmer Corbin, IBM
Past Chair Patricia La Londe (retired CareFusion)
Treasurer Francisco Paco Lopez, Metalsa
SAC Sylvester (Bud) Newton, Jr., Alcoa
Secretary William J. Troy, ASQ Brady Boggs, Randy Brull, Jane Campanizzi,
Larry Haugh, Jim Jaquess, Gary MacLean,
Directors R. Dan Reid, Richard Stump
Donald Brecken Ferris State University
Jim Creiman Northrop Grumman Corp. Technical Reviewers
Ha C. Dao Emerson Climate Technologies Naveen Agarwal, Ashraf Ali, Suresh Anaganti,
David Levy Boyce Technologies M. Onur Artan, Andy Barnett, Matthew
Barsalou, David Bonyuet, David Burger,
Austin S. Lin Google
Brooks Carder, Bernie Carpenter, L.N. Prabhu
Raul Molteni Molteni Consulting
Chandrasekaran, Ken Cogan, Linda Cubalchini-
Luis G. Morales Daimiler Trucks North America Travis, Ahmad Elshennawy, Mark Gavoor,
Mark Moyer CAMLS Kunita Gear, Daniel Gold, T. Gourishankar,
Daniella A. Picciotti Veridiam Roberto Guzman, Ellen Hardy, Lynne Hare,
Barrie Simpson Genentech Access Solutions Victoria Jones, Trevor Jordan, Ray Klotz, T.M.
JoAnn Sternke Pewaukee School District Kubiak, William LaFollette, Scott Laman, Pradip
Sunil Thawani Quality Indeed Consulting Mehta, N.S. Narahari, Arind Parthasarathy,
John Vandenbemden Q-Met-Tech Larry Picciano, Gene Placzkowski, Tony
Polito, Peter Pylipow, Imran Ahmad Rana,
Allen Wong Abbott
John Richards, James Rooney, Ayman Sakr,
Administration Manboubeh Samghabadi, Brian Scullin,
William J. Troy, CEO Abhijit Sengupta, Amitava Sengupta, Mohit
Seiche Sanders, Publisher Sharma, A.V. Srinivas, Adrian Tan, Joe Tunner,
B. Vaithiyanathan, Manu Vora, Keith Wagoner,
QP Editorial Review Board Jack Westfall, Doron Zilbershtein
Randy Brull, Chair
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 minority views. Opinions expressed are those of the
authors and not necessarily of ASQ or Quality Progress. Use of the ASQ logo in advertisements does not necessarily
constitute endorsement of that particular product or service by ASQ.

qualityprogress.com May 2017 QP 5

SEEN&HEARD
Reader reactions from around the world

7
REVISIT A GOOD REFRESHER
In response to Statistics Spot-
light: Revisiting the Old
Seven (April 2017, pp. 42-45):
You have succeeded in finding
a very user-friendly approach
for these tools, keeping them
fresh for readers to continue to
apply them. Thank you!
Catalina Tutulea
Dambovita County, Romania

AUDIT APPRECIATION
I liked this One Good Idea: Rethink-
ing Audit Reports (December 2016,
p. 79). The authors message that an
audit should not be just a fault-finding
exercise and should result in improve-
ment applies to every auditor of every
discipline such as finance, quality man-
agement systems and environmental
management systems. As a manage-
ment representative, I used to impress
on internal and external auditors that an
indication of a good audit is the thankful
acknowledgement by the auditee that the
audit and the nonconformances raised
will really improve them.
Ramaswamy Ganesan
Pondicherry, India
POINTS ON PDCA
After digging deep into the contents of
the article (Back to Basics: The Gravity of
PDCA, January 2017, p. 64), Im con-
vinced that theres science and logic
behind the plan-do-check-act (PDCA)
cycle. Using PDCA is similar to conducting
scientific research and proving the theory
behind it. Whether we label it or not,
we are using it in our daily lives, but not
always in a conscious way. This is a good
article worth reading.
Nayel Altarawneh
Doha, Qatar

THE REACTION GAUGE

this month's question Drones continue to be touted as the new game-changing
technology that will affect how retailers deliver packages,

farmers monitor crops and livestock, developers access

Despite some recent accidents and
concerns during testing, manufacturers
and companiessuch as Ford, General
Motors, Tesla, Alphabet and Applecon-
tinue to move forward with self-driving
vehicles.
Are self-driving vehicles ready for the
road? Would you feel safe in traffic as a
passenger in a self-driving vehicle or a
fellow driver sharing the road with one?
Are manufacturers and companies rushing
this emerging technology to market too
quickly?
Send us your take at editor@asq.org.
properties and engineers survey projects, for example.
last month's question What concerns you most about the advancing drone
technology? Are government agencies doing enough to
regulate drone usage?
Franz Todt, Peoria, IL, writes: Muthuraman Annamalai,
The drone issue is going to be a prob- Charlotte, NC, says:
lem. We sit back and delight in our use Air safety is going to be a cause of
of drones to kill people overseas. But concern with the operation of drones.
what about when these come home as A commonly referred statistic is that
is already happening? Think about law odds of a commercial plane crash are
enforcement in our own country using one for every 1.2 million flights. With
drones constantly patrolling, watch- falling prices of drones, there is going to
ing and ready to respond. You present be a vast number of drones in the air in
commercial applications, which will help the coming years. Capt. Chesley Sully
give acceptance by the public, but what Sullenberger has been quoted as saying,
is the real plan? Government control of It is not a matter of if it will happen. It is
everyone. a matter of when it will happen.

6 QP May 2017 qualityprogress.com

 Subject matter experts take on your quality-related queries
THIS MONTH'S QUESTION
Im new to auditing and would like more
information pertaining to its substance. What
I mean is: What can be done with an auditing
certification? Where can I generally use it and in
what industry? How far can I go with it?
OUR RESPONSE
Speaking from personal experience,
theres a lot that can be done with an
auditing certification. An excellent place
to start is with ASQs quality auditor certi-
fication. As a certified quality auditor, you
will have fundamental auditing knowledge
and be familiar with audit processes,
auditor competencies, audit program
management, and quality tools and tech-
niques. Conducting quality and process
audits will allow you to apply what you
have learned, meet people across the
organization and learn about many of the
organizations processes. That knowledge
will expand if you conduct supplier audits.
In addition to the quality auditor
certification, other auditor certifications
are available. For example, Exemplar
Global and the International Register
of Certificated Auditors provide lead
auditor certifications, which can be used
to become an auditor with an accredited
ISO 9001 certification body (for exam-
ple, British Standards Institute, Lloyds
Register Quality Assurance, National
Quality Assurance and TV).
Working as an auditor with one
of these organizations will
provide you with even
more opportunities
to audit a variety of
organizations and to
travel. There are also
industry-specific auditor
certifications for hazard analysis, critical
control points (food production), medical
devices and biomedical systems, as well
as for software (TickITplus) and automo-
tive (Automotive Industry Action Group
International Automotive Task Force).
Having an industry-specific certification
will improve your credibility as an auditor
in that industry.
Where you can use it
Quality and process audits are conducted
in nearly every manufacturing and service
industry around the world. For example,
think about all the organizations that have
achieved ISO 9001 certification. Those
certifications span all industries.
Each of those certified
organizations is
audited by
its own
internal
auditor as well as certification body
auditors.
How far you can go
As an auditor, you will develop skills
related to planning, team management,
leadership, interviewing, time manage-
ment, data and information analysis,
problem solving, root cause analysis,
decision making, reporting, presenting
and conflict resolution. Many of the skills
developed as an auditor can be trans-
ferred to other careers, such as quality
engineer, Six Sigma Black Belt, process
improvement specialist, project manager
and quality manager. Many organizations
value the skills, experience and broad
exposure you will have as an auditor.
How far you go is up to you.
This months response was
written by Ken Cogan, project
manager, MaxtenaInc.,
Rockville, MD. Visit them at
www.maxtena.com.
qualityprogress.com May 2017 QP 7
 A digest of
trends, research
& late-breaking
news

TECH N O LOGY

False Sense
of Security?
Despite hiccups, chip cards reduce
in-store fraud, but online hacks persist

If youre like most U.S. consumers, you use your credit or debit card regularly While chip card technology has helped
possibly daily. At some point in the last two years, its likely you were issued new reduce fraudulent activity in stores, experts
cards with chip technology. When you go to pay for items at a store, you now may be say it may be giving consumers a false
required to insert your card into the chip reader, rather than swipe the magnetic strip sense of security because it has spawned a
on the cards back. new rise in online fraud.7 So much so that in
That little chip is known as Europay, MasterCard, Visa (EMV) technology. EMV is the 2016, online fraud rose 40%.8
global standard for credit and debit cards that use computer chips to authenticate
transactions.1 Its meant to make point-of-sale transactions more secure to prevent Physical fraud made
identity and card fraud. Unlike the magnetic strip, the chip creates a unique transaction more difficult?
code that cant be reused. 2 The good news is that EMV technology
Of course, you may have dealt with some of the hiccups that come with chip card seems to help curb in-store, or card-present,
adoption. First, retailer migration to the technology has been slow. Major credit card fraud. Chips are safer and encrypt informa-
companies gave retailers an Oct. 1, 2015, deadline to install chip card readers in their tion more securely than magnetic strips.
point-of-sale terminals. After that date, if a counterfeit credit card was swiped in a store For retailers who upgraded to EMV card
that didnt have a chip card reader, the liability fell on the merchant. Previously, the readers, Visa reported a 47% decline in
liability belonged to the credit card company. 3 card fraud in May 2016 when compared to
By October 2016, just one-third of retailers had migrated to EMV point-of-sale read- May 2015. According to MasterCard, mer-
ers.4 Some of this lag time was due to a slower testing and certification process: Every chants who had adopted EMV technology
EMV-enabled terminal must be certified by EMVCo, which manages the EMV specifica- or were close to implementing it experi-
tions and the credit card brands the business accepts for payment. 5 enced a 54% decline in counterfeit card
Furthermore, faulty chips and chip readers, and slow processing times left many fraud in April 2016 compared to April 2015.9
customers frustrated by longer checkout lines and caused some retailers to resist the Also, merchant adoption is beginning to
move to a new chip-reading system.6 pick up. Researchers say that in the next
So, have the growing pains been worth it? Has EMV technology helped resolve card three to four years, 84% of merchants will
and identity fraud in the United States? have made the migration.10 Even some

8 QP May 2017 qualityprogress.com

 Tune In
ASQTVs latest episode examines a new approach
to five whys and root cause analysis, and gives a
refresher on is/is not analysis. Visit http://videos.
asq.org to access the full video library.

of the user complaints are being tended to: In March, for example, Square, a NEWS BRIEFS
financial payments firm, introduced an update to increase payment speed.11
Still, experts say, chip cards havent stopped fraud. Theyve just forced crim-
inals to find new methods. FALL CONFERENCES SET
The American Statistical Asso-
Card-not-present fraud on the rise ciation will host its Symposium
While EMV technology seems to be effective at preventing card numbers and on Statistical Inference Oct. 11 in
information from being stolen from point-of-purchase terminals, it is not used Bethesda, MD. For more informa-
for online transactions, which means fraudsters are moving to the web and
tion, visit https://ww2.amstat.org/
committing whats called card-not-present fraud.
meetings/ssi/2017.
One study predicts that between 2016 and 2020, up to $10 billion in fraud
will be committed. The majority of that, researchers estimate, will be from
credit card numbers stolen online and through mobile channels. Because
The Association for Manufac-
youre not required to enter a PIN or provide a signature when making turing Excellences lean and
online purchases, all hackers generally need to commit online fraud is a card continuous improvement confer-
number.12 ence will take place Oct. 9-13 in
There are other types of card-not-present fraud consumers should be aware Boston. Visit www.ame.org/boston
of, too. for more details.
Application fraud happens when hackers steal your information to open
new credit card accounts. An example is the Anthem health insurance breach The Institute of Electrical and
in 2015. Researchers estimate this type of fraud will account for $2.1 billion in Electronics Engineers fourth
fraud by 2020. annual international conference
Another type of fraud is account takeover. This occurs when hackers find on data science and advanced
ways to log in to consumer and business accounts online and empty money
analytics will be Oct. 19-21 in
from the accounts. Researchers suspect this type of fraud to reach $1 billion
by 2020.13
Tokyo. For more information, visit
continued on page 10 www.dslab.it.aoyama.ac.jp/dsaa2017.

Mr. Pareto Head by Mike Crossen

qualityprogress.com May 2017 QP 9

False Sense A C C R E D I TAT I O N

of Security? ACG-ANAB Unveil Plans

continued from page 9
Online fraud
As EMV technology continues
to help defend consumers from
point-of-purchase security
breaches, how are retailers and
credit card companies working
to combat soaring rates of
online fraud? Could EMV tech-
nology move online?
Some retailers have explored
The Allergan Control Group Inc. (ACG) has announced
requirements for ACG-recognized certification bod-
2. Sienna Kossman, 8 FAQs About ies (CB) to transition to ANAB accreditation. This is in
EMV Credit Cards, Creditcards. keeping with the previously announced plan to sep-
com, http://bit.ly/1jtE51p (case
arate ACG as the Gluten-Free Certification Program
sensitive).
3. Herb Weisbaum, One Year On,
(GFCP) standard owner from the accreditation of CBs
in the program. For more information, visit http://
Are Chip Cards EffectiveOr
Just Very Annoying? NBC News, tinyurl.com/acg-anab-accredit.
Oct. 10, 2016, http://nbcnews.
to/2dLjXsi (case sensitive).
4. Ibid. ISO S TA N D A R D S
5. QuickBooks, EMV Costs,
Certifications and More: What
You Need to Know Before New ISO/IEC 80000
Secretary-
the Migration, http://intuit.

UNDER REVIEW
ways to boost online payment me/2onJMEW (case sensitive).
security, including fraud detec- 6. Weisbaum, One Year On, Are

tion softwaresuch as 3-D
Secure or tokenization, which
don't require retailers to store
sensitive customer information
on their networks.
You also may soon see verifi-
cation systems that require two
steps when checking out. How-
ever, as Avivah Latin, research
vice president for Gartner, a
technology research corpora-
tion, said, he expects Visa and
MasterCard to eventually direct
retailers to adopt EMV online
because credit and debit cards
arent going anywhere."14
compiled by Amanda
Hankel, contributing editor
REFERENCES
1. SquareUp.com, http://squ.
re/2oUcSw7 (case sensitive).
General
Chip Cards EffectiveOr Just
Very Annoying? see reference 3.
The ISO/IEC 80000
7. Maggie Overfelt, Hackers Rush quantities and units
to Cash in on $14 Billion in Fraud
Before Chip Cards Take Over,
cnbc.com, May 6, 2016, http://
Named
The International
series of standards
is currently under
revision. The series
cnb.cx/1O488f2 (case sensitive).
8. Jeff Bukhari, That Chip on Your Organization for consists of 13 differ-
Credit Card Isnt Stopping Fraud
After All, Fortune.com, Feb. 1,
Standardization ent parts, featuring
2017, http://for.tn/2kAAOSF (case (ISO) has appointed 11 from the Interna-
sensitive). Sergio Mujica as its tional Organization
9. Weisbaum, One Year On, Are
Chip Cards EffectiveOr Just
new secretary-gen- for Standardization
Very Annoying? see reference 3. eral, effective in (ISO) and two from
10. Overfelt, Hackers Rush to Cash July. Mujica has the International
in on $14 Billion in Fraud Before
Chip Cards Take Over, see been the deputy Electrotechnical
reference 7. secretary-general of Commission (IEC).
11. Ethan Wolff-Mann, Squares Chip
the World Customs Some of these
Credit Card Readers Just Got 14%
Faster, Yahoo Finance, March Organization for the standards are
24, 2017, https://yhoo.it/2n1TCsp last seven years. approaching a cru-
(case sensitive). cial and final stage
12. Overfelt, Hackers Rush to Cash in
on $14 Billion in Fraud Before Chip
of their revision. For
For more information, visit
Cards Take Over, see reference 7. www.iso.org/news/
more information,
13. Ibid.
Ref2176.html (case visit http://tinyurl.com/
14. Ibid.
sensitive). iso-iec-standards.

New @ ASQ AWARD ANNOUNCED Shawn Armstrong was named this

years recipient of ASQs Customer-Supplier Divisions
What's on our minds
Charles E. Meadows Award, which recognizes individuals
who have demonstrated outstanding service to the cus-
tomer-supplier field.
NOMINATIONS SOUGHT ASQs Statistics Division is now
accepting nominations for this years William G. Hunter
Award. The award, named for the divisions founding
chair, recognizes outstanding leaders in the field of
applied statistics. Deadline to submit nominations is June
30. For more information, visit http://asq.org/statistics/
about/william-g-hunter-award.
WEBINAR PLANNED The ASQ Reliability Division is host-
ing a webinar on the design and analysis
of experiments in Minitab. The webinar
takes place 11 a.m. CDT May 11. For more
information and to register, visit www.
asqrd.org/webinars/203.

10 QP May 2017 qualityprogress.com

 RESEARCH

QMD STUDIES
ORGANIZATIONAL GETTING TO KNOW

EXCELLENCE Charles C. Roberts

MEMBER PARTICIPATION ENCOURAGED
current position education
ASQs Quality Management Division is researching
the current state of organizational excellence and is U.S. Air Force lead metrology Bachelors degree in business
laboratory evaluator. quality management from
asking ASQ members to provide feedback. Southwestern College in
The study is being conducted by the divisions Winfield, KS.
organizational excellence technical committee and
Dawn Ringrose of Organizational Excellence Spe- What was your U.S. Air Force Metrol- ASQs International
cialists, who is using an integrated excellence model ogy and Calibration Team Excellence
introduction to Center in Heath, OH. Award.
and automated assessment and reporting tool. The quality? I also serve as a lead
research is endorsed by the Global Benchmarking evaluator, leading
small teams and Do you have
Network and International Organization for Standard- As a calibration
ization technical committee 176. training the evaluation amentor?
technician, I was cadre while aligning
introduced through inspections with the
the quality programs Early in my career
inspector general
located at all U.S. in the military, my
construct.
Air Force metrology first two supervi-
ASQ members can participate in an abbre- labs. The programs sorsBilly Potts and
viated assessment (http://tinyurl.com/ have developed over Any recent honors Mickie Greenhelped
org-assess-teaser) or full assessment (http:// the years, but the or awards? me to be successful
tinyurl.com/org-assess-full). Individual principles of process and develop work
improvement have habits that are still
results will remain confidential and only always remained at I received the ASQ with me today. More
aggregate results will be shared at www. the forefront. Inspection Divisions recently, Cheree
linkedin.com/groups/4369749. Chuck Carter Inspec- Lewis has helped
Respondents can download a copy of the tor of the Year Award. me to maintain my
Previous note motivation and make
integrated model in English and Spanish at worthy jobs? small adjustments
http://organizationalexcellencespecialists.ca. What were the last as new opportuni-
books your read? ties have presented
Throughout my themselves.
20-plus years in the
Air Force, I held many Gemba Kaizen
positions such as (McGraw-Hill, 1997) Personal
calibration technician by Masaaki Imai, and
and supervisor, and Genghis: Birth of an I have a wife, Carolyn,
leadership instructor. Empire (Delacorte and three children:
H E A LT H C A R E Press, 2007) by Conn two sons, 17 and 18,
Iggulden. My favorite
Whats the best and a daughter, 16.

Patient Advocacy Groups Merge

authors are Iggulden
career advice you and Stephen King.
What do you do
ever received?
The Institute for Healthcare Improvement and the National Have you ever for fun?
Patient Safety Foundation will merge this month. The two Success doesnt come written an article?
patient advocacy organizations together will continue to raise to the smartest per- Reading and watch-
awareness about safety issues and educate son in the room, but ing TV, including
Chasing the Check-
the healthcare workforce about best rather the hardest- sports, The Big Bang
list, Quality magazine,
working person in the Theory and Game
practices. For more information, visit March 2016.
room. You create your of Thrones.
www.npsf.org/news/333839/ own opportunities
institute-for-healthcare- to grow and succeed Are you active Quality quote
improvement-and-npsf- through devotion and inASQ?
hard work.
agree-to-merger.htm. Dont strive for per-
I am the voice of the fection, but strive for
Outside activities? customer chair for improvement. Many
ASQs Measurement small steps will take
Im a member of the Quality Division and you much farther
evaluation team at the served as a judge for than a leap.

qualityprogress.com May 2017 QP 11

 Zooming in on industry-specific issues

eld Notes
FDA REGULATION

Sorting It
Out Making sense of the many guidance
documents, standards related to medical
device risk management
by Scott A. Laman

Medical device risk management is an interesting and decisions regarding the ISO 14971 basics
rewarding profession because we perform critical analy- application of risk manage- The basic deliverables of
ses throughout a products life cycle to protect patients ment are often not black and ISO 14971 are clear: a risk
and users from harm. Risk management also can be a chal- whitethere are many ways management plan, a risk
lenging subject as a technical field and as a topic that elicits to demonstrate compliance. analysis or analyses of various
many opinions and emotions regarding specific implemen- In addition, risk manage- types that meet the detailed
tation details. ment is intuitive because requirements, a risk manage-
In 2012, the European standard, EN ISO 14971 Risk man- we apply the concepts in ment report, and a system
agement for medical devices,1 was revised and has become most areas of our lives. For to collect and review pro-
the standard for organizations throughout much of the example, we routinely and duction and post-production
world. However, ISO 14971Medical devicesapplication subconsciously estimate the information, all of which are
of risk management to medical devices2 (no EN) was last severity of some form of harm to be documented in the risk
revised in 2007 and remains the standard for organizations and the probability of some management file. None of
in the United States. type of cause, whether the that changed with EN ISO
Within the last few years, there have been several U.S. subject is medical, financial, 14971:2012. However, the
guidance documents and technical information reports relational or driving a car. 2012 revision goes above and
(TIR) issued that solely recognize ISO 14971:2007, which Therefore, we are all experts beyond in several areas.
further muddies the waters with respect to how a global in the general application The purpose of EN ISO
organization can best demonstrate compliance to the EN of risk management, which 14971:2012 was to establish
and non-EN version of ISO 14971 within the confines of a can make it difficult to obtain consistency with European
simple quality system. consensus in a medical device Union Medical Device Direc-
Compounding that duality challenge is the people side business across all geogra- tive, 93/42/European
of medical device work. Unlike some technical subjects, phies and divisions. Economic Community (EEC),3

12 QP May 2017 qualityprogress.com

commonly known as the Med-
ical Device Directive (MDD).
Annex ZA describes the
changes in the form of what
are called content deviations.
Briefly, the new or clarified
requirements of EN ISO
14971:2012 are:
++ Each individual residual
risk and the overall residual
risk must be reduced as
far as possible (AFAP)
even risks identified as
negligible.
++ Risk-benefit analysis must
be conducted for each
individual risk, as well as for
the overall risk (weighing all
risks combined against the
benefit).
++ If as low as reasonably
practicable (ALARP)
terminology is used in the
risk management file, eco-
nomic considerations must
not be used to justify risk
acceptability.
++ All the control options must
be applied and not stopped
if the first or second control
option has reduced the risk
to an acceptable level.
++ No additional risk reduction
may be attributed to infor-
mation given to the users.
To address the changes,
organizations have imple-
mented any or all of the
following fixes, although there
are many different approaches
with respect to specific
details that may demonstrate
compliance:
++ Eliminate ALARP termi-
nology. Document the
reduction of all risks AFAP
If an organization
proactively and
comprehensively
documents device
benefits as well
as risks in the risk
management file,
post-market decisions
that affect product
availability can be
more objective and
fact based, and less
judgment based.
in individual risk analyses
and the risk management
report.
++ Document risk-benefit
analyses for each individual
risk (that is, line item) in the
risk analysis. Document the
overall risk-benefit analysis
in the risk management
report.
++ State in the governing
internal standard operating
procedure and in the risk
management report that
all the control options have
been applied and no risk
reduction credit was given
for residual risk disclosure,
such as warnings and
precautions.
Ultimately, in a global
organization, it is desirable
to create and maintain risk
management files to com-
ply with EN ISO 14971:2012
because the requirements
generally include those of ISO
14971:2007.
Differences of opinion
Revisiting the people side of
the job, all of these imple-
mentation details provide
opportunities for differences
of opinion to develop. For
example, a risk-benefit analysis
on an individual risk may be:
++ A general, repeated state-
ment on each line of a risk
analysis.
++ A comprehensive statement
specific to each particular
risk.
++ A reference to where the
risk-benefit statement
can be found, such as in a
clinical evaluation or risk
management report.
To work through the inev-
itable differences of opinion
regarding exactly how to
implement the details of any
standard, two questions must
be asked:
1. Do we want to
standardize?
2. Is there consensus
regarding best practice to
standardize on?
Depending on the answers
to these questions, details
regarding next steps have
been previously introduced in
a 2 x 2 matrix called a consen-
sus chart.
While ISO 14971 is the
foundation for medical device
Do you have a suggestion on a topic or industry that
Field Notes should focus on? Let us know your thoughts
by sending us a note at editor@asq.org.
qualityprogress.com May 2017
risk management, several
related guidance documents,
reports and standards build
on the concepts. In the United
States, current hot subjects
include the application of ISO
14971 to usability and human
factors, cybersecurity and
risk-benefit determination.
Last December, the U.S.
Food and Drug Administration
(FDA) guidance document
Factors to Consider Regard-
ing Benefit-Risk in Medical
Device Product Availability,
Compliance and Enforcement
Decisions was issued. If there
was any doubt the FDA does
not recognize the EN version,
appendix A clearly states ISO
14971 is an FDA-recognized
standard ...5
While this guidance was
written for post-market non-
conforming or noncompliant
product issues, the principles
can be applied proactively in
developing an EN ISO 14971
risk management file. While
it is simple to systematically
document risks in a hazard
analysis performed early in
product design, benefits can
be less clear at that time.
As a potential mind-jog-
ging tool, the FDA guidance
describes the following factors
that may be considered to
QP 13
Field Notes

characterize device benefits: impact on patient health and 62366:2015-Part 1Applica- In summary, the prolifer-
clinical management, magnitude of benefits, likelihood of tion of usability engineering ation of related guidance
patients experiencing the benefits, duration of effect, patient to medical devices,11 a stan- documents and standards, the
perspective, benefits for healthcare givers and medical neces- dard that all risk management need to demonstrate com-
sity. These are the types of benefits that must be considered professionals should under- pliance to ISO14971 and EN
and balanced against each individual risk and all risks taken as stand and apply. Those of ISO 14971, and the countless
a whole. us who work with medical ways in which details can be
If an organization proactively and comprehensively docu- equipment also should be implemented all make medical
ments device benefits as well as risks in the risk management familiar with IEC 60601-1- device risk management a
file, post-market decisions that affect product availability can 6:2010, General requirements challenging career, but it is
be more objective and fact based, and less judgment based. for basic safety and essential also a fantastic opportunity to
performance.12 do good for many people.
Cybersecurity threats
In our fast-changing world of increasing computer capabilities,
REFERENCES
cybersecurity is another hot topic. The FDA issued the guid-
1. European Committee for 7. Association for the Advancement
ance document Postmarket Management of Cybersecurity in Standardization (CEN), EN ISO of Medical Instrumentation
Medical Devices in December 2016.6 The guidance applies to 14971Risk management for (AAMI), AAMI/Technical
medical devices, 2012. Information Report (TIR)
devices that contain software or programmable logic, or soft-
2. International Organization for 57:2016Principles for
ware that is itself a medical device. Devices that are networked Standardization (ISO), ISO 14971 medical device securityRisk
are particularly vulnerable. Medical devicesapplication management, June 2015.
of risk management to medical 8. CEN, EN ISO 14971 Risk
In this guidance, a link is made between cybersecurity risk
devices, 2007. management for medical devices,
and overall risk to health, with the foundation for cybersecu- 3. European Commission, European Annex ZA, 2012.
rity risk management coming from 21 CFR 820. A more direct Union Medical Device Directive, 9. AAMI, AAMI/TIR 57:2016
93/42/European Economic Principles for medical device
parallel between cybersecurity and ISO 14971 can be found in
Community (EEC), June 14, 1993. securityRisk management, see
Association for the Advancement of Medical Instrumentation 4. Scott A. Laman, Building a reference 7.
(AAMI) TIR 57:2016Principles for medical device secu- Consensus, Quality Progress, 10. FDA, Applying Human Factors
October 2009, p. 72. and Usability Engineering to
rityRisk management.7 Consistent with U.S. philosophy, the
5. U.S. Food and Drug Medical Devices, guidance
introduction states This document does not address content Administration (FDA), Factors document, Feb. 3, 2016.
deviations included in Annex ZA of EN ISO 14971:2012.8 to Consider Regarding Benefit- 11. International Electrotechnical
Risk in Medical Device Product Commission (IEC), IEC
Specifically, the AFAP requirement is not included in the
Availability, Compliance and 62366:2015-Part 1Application of
evaluation of security risks. TIR57 recommends that a security Enforcement Decisions, guidance usability engineering to medical
risk process be developed that is separatenot integrated document, Dec. 22, 2016. devices, 2015.
withthe safety risk process.9 Cybersecurity does have its own 6. FDA, Postmarket Management 12. IEC, IEC 60601-Parts 1-6:2010,
of Cybersecurity in Medical General requirements for basic
terminology, including identification of threats, vulnerabilities Devices, guidance document, safety and essential performance,
and assets. Cybersecurity risks that affect patient and user Dec. 28, 2016. 2010.
safety, however, also should be documented in the safety risk
management file. In a global organization, the full requirements
of EN ISO 14971 should be addressed.
Device use risk also continues to receive much focus.
The FDA guidance Applying Human Factors and Usability
Engineering to Medical Devices was issued in February
2016.10 Although user error has long been part of the tril- Scott A. Laman is senior manager of
quality engineering and risk management
ogy of design, process and use risks identified in a top-level for Teleflex Inc. in Reading, PA. He
hazard analysis, the guidance provides more details regarding earned a masters degree in chemical
identifying and analyzing critical tasks, and applying usabil- engineering from Syracuse University
in New York. Laman is an ASQ fellow
ity failure mode and effects analysis and fault tree analysis. and a certified manager of quality/
A particularly detailed section on human factors validation organizational excellence, quality
testing is helpful. engineer, reliability engineer, Six Sigma Black Belt, quality
auditor, supplier quality professional and biomedical auditor. He
The usability engineering process is shown in parallel to is also an ASQ fellow, a past chair of the ASQ Professional Ethics
ISO 14971 in International Electrotechnical Commission (IEC) and Qualifications Committee.

14 QP May 2017 qualityprogress.com

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F E AT U R E
SERVICE QUALITY

A new perspective on a classic model

helps healthcare organizations better
understand patient expectations,

M ind
service deficiencies

the
Ga ps by Denise M. Kennedy

16 QP May 2017 qualityprogress.com

Surveys of customers across various economic influence service-quality ratings. When evaluating a
sectors, including healthcare, indicate decreas- service, customers consider five basic dimensions:
ing satisfaction with service.1 Delivering better 1. Reliability.
service requires an understanding of three unique 2. Responsiveness.
characteristics: 3. Empathy.
1. Services are intangible performances. 2, 3 A bell- 4. Assurance.
hop who smiles and willingly helps hotel guests is 5. Tangible evidence, such as facility and amenities.6
performing a service. The bellhops service is not Reliability is most important to customers who sim-
evaluated by touch or quantifiable means, but by ply want service organizations to deliver what they
how he or she makes guests feel. promise.7 Responsiveness, empathy and assurance
2. Services are provided by people, and this human refer to how a service is provided.
element introduces variability into service If an outpatient clinic, for example, advertises
processes. 4 Service providers behav- its cardiology services, prospective
iorsand therefore, the quality of their patients expect to receive appointments
Just the
servicesvary hourly, daily and from when they call the clinic. While tangible
Facts
customer to customer, depending on evidencesuch as beautifully designed
the situation. Service quality can be The gaps model facilities and glossy marketing brochures
negatively affected by an employees can help orga- can offer clues to service quality, it cannot
nizations define
physical and emotional well-being. how customers support a clinics service reputation if a
This is especially true of labor-inten- evaluate service core servicesuch as providing appoint-
by comparing
sive healthcare services, in which their preservice mentsis unreliable.
demands on doctors and staff can be expectations to While these service principles can
their perceptions
overwhelming. during and after be applied to all service organizations,
3. Services are simultaneously produced the experience. understanding how customers rate
and consumed. 5 During a medical Mayo Clinic Ari-
service quality is especially important to
appointment, a doctor provides a zona (MCA) used healthcare organizations because the total
servicerecording medical history and the gaps model experience is multifaceted. Most patients
to help managers
symptoms, ordering tests, determining identify, catego- lack the technical knowledge to evaluate
a diagnosis and developing a treatment rize and analyze the quality of their medical care, so they
likely causes of
planas the patient consumes it. poor healthcare often rely on familiar service clues if asked
These three characteristicsintan- service quality. to rate overall quality. 8
gibility, variability, and simultaneous Applying the Patients also are customers of retail
production and consumptionmake it model improved service giants such as Southwest Airlines,
MCA patient sat-
difficult for customers to evaluate service isfaction ratings from which they routinely experience
quality. for physician and excellent service. Service excellence out-
nurse interactions,
turnaround time side of healthcare can influence service
Understanding perceptions for test results,
and perception of
expectations in a clinical setting where
To improve a service, you must under- efficiency in the patients ratings of healthcare quality can
stand customers perceptions and internal medicine be influenced by factors such as:
department.
expectations and how these factors ++ A staffs level of caring, compassion

qualityprogress.com May 2017 QP 17

 F E AT U R E
SERVICE QUALITY
and friendliness.
++ The quality of communication.
++ Concern for patient privacy.
++ Facility cleanliness.
Positive patient experiences generate better
satisfaction scores, which increase revenue under
value-based payment models. Better service also
generates more positive word-of-mouth advertising,
increasing patients willingness to pay as they assume
more personal financial responsibility for their health-
care.9, 10
The gaps model of service quality
The gaps service-quality model was published in
1985 as a result of in-depth interviews with executives
and focus-group interviews with customers from
four national service firms.11 The model helped define
service quality and contributed to an emerging body
of knowledge about how customers evaluate service.
Consumers compare their preservice expectations
to their perceptions of the overall experience. If the
experience exceeds expectations, the result is a positive
FIGURE1
Likely causes of poor service quality
and impact on patient experience
Adapted from A. Parasuraman, Valarie A. Zeithaml and Leonard L. Berry, A
Conceptual Model of Service Quality and its Implications for Future Research,
Journal of Marketing, Vol. 49, No. 4, Autumn 1985, pp. 41-50.
18 QP May 2017 qualityprogress.com
customer gap, and excellent service is perceived. Con-
versely, if the experience falls short of expectations, the
result is a negative gap, and poor service is perceived.
This overall customer gap (gap five) is a func-
tion of four service discrepancies (or gaps) in an
organization:
1. Gap onenot understanding customer
expectations.
2. Gap twonot designing processes and perfor-
mance standards around customer expectations.
3. Gap threenot hiring, educating and training ser-
vice-minded people to ensure service is delivered
as designed.
4. Gap fournot communicating accurately
about service delivery to set realistic customer
expectations.
The gaps model defined service quality at the orga-
nizational level from the perspectives of customers,
service executives and service marketers. Although
this exploratory study did not include healthcare
organizations, the model has use for improving the
quality of medical services.
The gaps model can help managers
identify, categorize and analyze likely causes
of poor healthcare service quality at the
department levelwhere there is control over
people and processes. Many teams at Mayo
Clinic Arizona (MCA) used the gaps model to
focus on service deficiencies from the clinical
operations managers perspective.
Finding service deficiencies
MCA is an integrated, multispecialty, phy-
sician-led, academic medical practice that
employs 450 physicians, 5,000 allied health
employees and serves 110,000 patients annu-
ally. Like most service organizations, MCAs
operations managers are accountable for their
departments key performance indicators, such
as financial and operational measures, and
patient satisfaction.12
MCAs service lead partners with oper-
ations managers to provide consultation,
such as data analysis and interpretation,
assessment of front-line service performance,
identification of opportunities for improve-
ment, service education for physicians and
staff, and design of monitoring and control
processes to improve service.13
Many of a clinical managers operational
dutiessuch as aligning appointment capac-
ity with patient demand, streamlining patient
flow, implementing service performance standards
and ensuring that staff performs to standards
directly affect patient satisfaction. The gaps model
was adapted for operations managers by restating
the four organizational service gaps as questions that
influence the total patient experience:
++ Gap oneDo we understand patient expectations
of MCA? If not, why? What is the effect on clinical
operations and the patient experience?
++ Gap twoDo we design processes and develop
service standards to meet patients expectations
of MCA? If not, why? What is the effect on clinical
operations and the patient experience?
++ Gap threeDo we hire, educate and train the
right people to deliver service that meets MCA
patient-defined standards? If not, why? What is
the effect on clinical operations and the patient
experience?
++ Gap fourDo marketing communications appro-
priately set patient expectations for MCAs service
delivery? If not, why? What is the impact on clinical
operations and the patient experience?
++ Gap five (the patient experience gap)Do
we consistently provide a healthcare
experience that meets MCAs patient
expectations? If not, why? What is the
effect on the patients perception of the
organization?
Gaps one and four are related to marketing
research, and advertising and communications,
respectively. Gap two (process design and service
standards development) and Gap three (hiring ser-
vice-minded people and ensuring service is delivered
as designed) are more closely aligned with operations
management.
By categorizing service deficiencies as either
related to external marketing or internal operations,
we preserve the models original intent: to distinguish
between factors inside and outside the organization.
Figure 1 illustrates the gaps model, adapted for
healthcare service consultation to help managers
see the four organizational gaps as potential service
deficiencies in their departments. It also shows them
how these deficiencies can contribute to a patient
experience that falls short of patient expectations.
Satisfaction and the patient
experience gap
MCA uses a national vendor to conduct ongoing sur-
veys of patient satisfaction. Patients are asked to rate
service quality related to physicians and mid-level
providers (physician assistants and nurse practi-
tioners), allied health staff (nurses, technicians and
nonclinical staff), the facility, overall quality and the
likelihood of recommending MCA to others on a five-
point scale (excellent, very good, good, fair or poor).

Hiring service-minded people and providing ongoing

education and training to ensure service is delivered
as intended is a method for closing gap three, the
service-delivery gap.

MCAs operations managers monitor patient

satisfaction and manage to the best-possible score
(excellent) on the survey rating scale. In Figure 1, the
customer gap (the middle circle) was restated as
the difference between the 90th percentile patient
satisfaction target, which reflects leaderships under-
standing of patients expectations that MCA will be
among the best, and patient satisfaction ratings of
the service experience.
If a departments patient satisfaction scores are
below target, categorizing the service deficiencies
by gapsuch as people, process or marketing
(Figure 1s four corners)can help manager and staff
identify the likely causes of patient dissatisfaction.
Feedback on the clarity and simplicity of this tool
was positive.

qualityprogress.com May 2017 QP 19

 F E AT U R E
SERVICE QUALITY

TA B L E 1

Patient satisfaction with service

Key points in the internal medicine patient experience before
and after service intervention

Patient satisfaction before service Patient satisfaction six months after

intervention service intervention
Percentage Percentage
Survey question Percentage change
excellent excellent
Thoroughness of 65 72 7
medical exam
Spending enough time/ 69 87 18
not seeming rushed
Listening to patient 71 75 4
concerns
Involving patient in 66 75 9
decisions about care
Being courteous and
Provider

77 81 4
caring
Explaining medical 68 76 8
condition
Overall quality of care 73 81 8
from the provider
I feel [that] all the doctors are
I would have liked more time spent with extremely capable. They are
the doctor and been less rushed. exceptionally good at listening to me
Verbatim patient and following through.
comments My doctor could improve her bedside
manner. She does not have much I like the fact [the doctors] are on time
patience. and they dont seem rushed when you
know they are.
Instructions for caring 59 70 11
for self at home
Promptly informing 49 59 10
patient of test results
Overall quality of 61 67 6
nursing care
Allied health staff

Access to appointments 48 52 4
when needed
Perception of efficiency 57 68 11
Teamwork among 53 60 7
doctors, nurses and staff
Overall quality of care 65 71 6
from the practice
I like ... the way they run the facility.
I don't like how they schedule They are efficient and they try to work
Verbatim patient appointments. They just schedule with my schedule.
comments without asking if it's OK with me or if it's
convenient. If you need an appointment, they will
do everything they can to get it for you.

N = 140 patients

20 QP May 2017 qualityprogress.com

Closing gap one
MCAs ongoing market research has consistently
shown that patients have extraordinarily high
expectations of the Mayo brand. MCAs operations
managers understand patient expectations and try to
manage them proactively, beginning with scheduling
of the first appointment.
Staff ask questions up front to truly understand
a patients needs and expectations. Education is
provided to patients when it is necessary to reset
unrealistic expectations and close this gap. At MCA,
patient dissatisfaction is often related to processes
and standards that do not meet patient expectations,
which is the focus of gap two.
Closing gap two
Even healthcare organizations that conduct regular
market research to understand patients expectations
of their brands do not consistently design processes
and set service standards to meet them. MCAs market-
ing director presents quarterly brand-monitor survey
results at meetings of executive and clinical leaders to
help them understand evolving patient expectations.
MCAs operations managers and business process
analysts receive lean Six Sigma training and incorpo-
rate the voice of the customer into process design
and improvement.14 They also incorporate the voice of
the frontline staffemployees with rich insights into
patient expectations, process bottlenecks and work-
aroundsand likely causes of patient dissatisfaction.
Closing gap three
Hiring service-minded people and providing ongoing
education and training to ensure service is delivered
as intended is a method for closing gap three, the
service-delivery gap. MCAs operations managers
are involved in the hiring process, from reviewing the
candidate pool to selecting the final candidate.
Multidisciplinary interview panels use behavioral
interviewing techniques to select candidates most
likely to fit in MCAs service culture. The service lead
works with staff to develop role-specific service perfor-
mance standards, which help a manager communicate
service-delivery expectations and evaluate the staffs
service performance against consistent criteria.
Closing gaps four and five
Another key gap researchers identified was that ser-
vice marketers do not always understand the frontline
challenges to delivering quality service. To prevent
discrepancies between external advertising and
communication promiseswhich help shape patient
expectations and are under the service marketers
control, and people and process capabilities, which
are under the operations managers controlthe two
functional areas should work together.
MCAs marketing director regularly attends
meetings of clinical operations leaders to better
understand frontline physician and staff challenges
and ensure accurate advertising messages.
An experience that falls short of expectations is
a function of service gaps in an organization. When
an organization closes the four preceding gaps, the
result is closure of gap five (the customer gap), a bet-
ter experience and improved overall satisfaction.
Improving service in internal medicine
Service consultation in MCAs internal medicine
department began with reviewing complaint, patient
satisfaction and telephone data with physicians and
allied health staff. The gaps model was used to focus
the discussion on service-quality deficiencies that
likely contributed to patient dissatisfaction.
The staff identified these causes:
++ Gap onePatients expect the best at Mayo Clinic.
They expect appointments to be available when
needed, physicians to be unhurried, a thorough
medical examination to be conducted and test
results to be promptly reported.
++ Gap twoProcesses for scheduling and canceling
appointments and for reporting test results were
not designed with patient expectations in mind.
++ Gap threePatient satisfaction ratings and
verbatim comments indicated variable service
performance, specifically related to physicians
courtesy and caring and front-desk staff friend-
liness. Service performance standards for the
frontline staff had not been established.
++ Gap fourA facilitated discussion of messages
in MCAs advertisements and other promotional
materials helped staff understand how marketing
activities were likely to influence the patient expec-
tations, noted in gap one.
Results
Targeted interventions to close the gaps and improve
service quality included:
++ Discussing patient satisfaction ratings, patient
comments, and opportunities for improvement at
monthly department meetings.
++ Providing service-quality education to staff.
++ Partnering with staff to develop job-specific service
performance standards aligned with MCAs service
valuessolutions focused, empathetic, reliable,
qualityprogress.com May 2017 QP 21
F E AT U R E
SERVICE QUALITY
The shift to value-based
payment has altered the
dynamics of the healthcare
market. Patients are
paying more out of their
own pockets for medical
care, which heightens their
service expectations.
valuing others and exceeding expectations.
++ Providing a peer-facilitated, communication
skills-building workshop for physicians.
++ Promoting use of the online patient portal for
accessing test results.
++ Standardizing nurses results-reporting processes
for patients not using MCAs portal.
++ Resetting patients expectations by communicating
how and when they would receive their test results.
++ Standardizing appointment scheduling and cancel-
lation processes.
Patient satisfaction data before and six months
after these interventions are summarized in Table 1 (p.
20). The greatest improvements in patient perception
of excellent service quality were realized in physi-
cians spending enough time and not seeming rushed,
nurses instructions to the patient for caring for
themselves at home, nurses prompt reporting of test
results and perception of practice efficiency. Patient
comments about service quality from physicians and
staff also reflected desired improvements.
Three takeaways
Service quality improvement is a journey. Three
key lessons MCA learned may help other
22 QP May 2017 qualityprogress.com
service organizations enhance their customers
experiences:
1. Improve service by clarifying roles and respon-
sibilities. MCAs service model is a partnership
between the service lead, who has specialized
knowledge of the science of service quality and
factors affecting the patients service experience,
and managers, who have specialized knowledge of
operations and factors affecting a patients clinical
experience.
Like an internal auditor, the service lead is a man-
agement consultant with a highly visible, dotted-line
reporting relationship to the governing board and
CEO.15 The CEO, a champion for the patient experi-
ence, is visibly supportive and repeatedly clarifies
roles and responsibilities for service quality in the
organization.
2. Use customer feedback to guide service pro-
cess design and improvement. The only way to
measure perception of service quality is to ask
the customer. Compiling service-related metrics
from several sources creates a more complete
picture of service quality.16 Verbatim patient
comments from satisfaction surveys often provide
details about operations that give meaning to the
 quantitative ratings and clues to help prioritize
improvement projects.
3. Review marketing messages. Service marketers
should partner closely with clinical-practice leaders
to fully understand operational limitations so their
advertising messages set appropriate patient
expectations. Medicine is not an exact science, and
there are no guaranteed outcomes.
Sometimes, there are no additional treatment
options available. This MCA patient comment illus-
trates how advertising can unintentionally heighten
expectations and contribute to disappointment:
Excellent help finding answers for undiagnosed
patients was advertised. Wish I could have gotten
better answers. A little disappointed.
A new wave of healthcare
consumerism
Even the best service organizations have gaps
between the service they intend to provide and the
quality of the service delivered to their customers.
Healthcare organizations are no exception.
The shift to value-based payment has altered
the dynamics of the healthcare market. Patients
are paying more out of their own pockets for
medical care, which heightens their service
expectations.17
Payments to healthcare organizations are
decreasing, which creates a need to serve more
patients, further straining the system and con-
tributing to dissatisfaction. All of these factors
have the potential to increase any or all of the
service-quality gaps.
With this new wave of healthcare consumerism,
patients are apt to shop for services more discrim-
inately, using publicly available data to choose
organizations with the best quality and patient
satisfaction scores. They will be less tolerant of poor
service and more quickly leave providers that dont
satisfy their needs.
Investing in facilities is not enough. Healthcare
organizations must improve service quality. Doing
so requires market research to understand patient
expectations of the brand; processes and standards
designed to meet those expectations; the right
people hired, educated and trained to deliver service
as designed; and a partnership between marketing
and clinical operations to avoid advertisements that
overpromise.
Providing a better patient experience is the right
thing to do, and with the spread of value-based pay-
ment models, it helps sustain service organizations
for the future.
REFERENCES
1. American Customer Satisfaction Index (ACSI), ACSI
Utilities, Shipping, and Healthcare Report 2015,
May 2015, www.theacsi.org/news-and-resources/
customer-satisfaction-reports/reports-2015/
acsi-utilities-shipping-and-health-care-report-2015.
2. John E. G. Bateson, Do We Need Service Marketing? in
Marketing Consumer Services: New Insights, Science
Institute, 1977.
3. Lynn G. Shostack, Breaking Free from Product Marketing,
Journal of Marketing, Vol. 41, April 1977, pp. 73-80.
4. Bernard H. Booms and Mary J. Bitner, Marketing Strategies
and Organization Structures for Services Firms, in
Marketing of Services, James H. Donnelly and William R.
George, eds., Chicago: American Marketing, 1981, pp. 47-51.
5. Christian Gronroos, A Service-Oriented Approach to
Marketing of Services, European Journal of Marketing, Vol.
12, No. 8, 1978, pp. 588-601.
6. A. Parasuraman, Valarie A. Zeithaml and Leonard L. Berry,
A Conceptual Model of Service Quality and Its Implications
for Future Research, Journal of Marketing, Vol. 49, 1984, pp.
4150.
7. Ibid.
8. Michael R. Darby and Edi Karni, Free Competition and the
Optimal Amount of Fraud, Journal of Law and Economics,
Vol. 16, No. 1, 1973, pp. 67-86.
9. Frederick F. Reichheld, The One Number You Need to
Grow, Harvard Business Review, Vol. 81, No. 12, 2003, pp.
46-54.
10. A. Parasuraman, Leonard L. Berry and Valarie A. Zeithaml,
Understanding Customer Expectations of Service, Sloan
Management Review, Spring 1991, pp. 39-48.
11. Parasuraman, A Conceptual Model of Service Quality and
Its Implications for Future Research, see reference 6.
12. Denise M. Kennedy, Roshanek Didehban and John
P. Fasolino, Creating and Sustaining a Culture of
Accountability for Patient Experience, Patient Experience
Journal, Vol. 1, No. 2, 2014, http://pxjournal.org/journal/vol1/
iss2/9.
13. Denise M. Kennedy, Creating and Integrating a New Patient
Experience Leadership Role: A Consultative Approach for
Partnering with Executive and Clinical Leaders, Patient
Experience Journal, Vol. 2, No. 1, 2015, http://pxjournal.org/
journal/vol2/iss1/21.
14. Michael L. George, Lean Six Sigma for Service: How to Use
Lean Speed and Six Sigma Quality to Improve Services and
Transactions, McGraw-Hill, 2003.
15. Kennedy, Creating and Integrating a New Patient
Experience Leadership Role, see reference 13.
16. Denise M. Kennedy, Richard J. Caselli and Leonard L. Berry,
A Roadmap for Improving Healthcare Service Quality,
Journal of Healthcare Management, Vol. 56, No. 6, 2011, pp.
385-402.
17. Parasuraman, Understanding Customer Expectations of
Service, see reference 10.
Denise M. Kennedy is a clinical assistant
professor at Arizona State Universitys
School for the Science of Health Care
Delivery. She earned an MBA at Northern
Illinois University in DeKalb and is an ASQ
member.
qualityprogress.com May 2017 QP 23
F E AT U R E
ROOT CAUSE ANALYSIS

24 QP May 2017 qualityprogress.com

 Just the
Facts
The ability to form a good working hypothesis is an new information may have been gained while evaluat-
essential part of any thorough root cause analy- Forming a good
ing the hypothesis.
sis (RCA), but is a subject that has garnered little hypothesis is an Suppose machined parts are found to be rusted.
previous attention. important part of An investigator may hypothesize that the parts are
performing any
When performing RCA, it can be helpful to first empirical root wet with coolant when sent to the warehouse. This
form a tentative hypothesis to give investigators cause analysis hypothesis can be evaluated by determining whether
because it gives
something concrete that can be evaluated and poten- investigators a parts are indeed wet when sent to the warehouse.
tially move the investigation forward. Knowing the starting point for If the failure is sporadic, a simple experiment can be
problem solving.
five characteristics that make a good hypothesis will performed by intentionally wetting sample parts with
provide investigators even stronger footing on which To form a more coolant and storing them in the warehouse. The parts
robust hypoth-
to move their work forward. esis, you must would be checked periodically to see whether they
A tentative hypothesis, also known as a working incorporate five have rusted.
virtues, or char-
hypothesis, provides a starting point for an investi- acteristics, into A working hypothesis can be used to move an
gation.1 Granted, the hypothesis may be wrong, but it: conservatism, issue forward when the problems cause is unknown.
modesty, simplic-
having a working hypothesis gives you something ity, generality and Remember, its OK for a hypothesis to be wrong. It is
that can be evaluated. The hypothesis can be rejected refutability. better to quickly discard many incorrect hypotheses
if it is found to be incorrect, of course, and ideally, and reach the correct concussion than to insist with

Jump-start your root cause analysis with a good hypothesis that

incorporates five essential virtues | by Matthew Barsalou

qualityprogress.com May 2017 QP 25

 F E AT U R E
ROOT CAUSE ANALYSIS
absolute certainty a hypothesis is correct, thereby
prolonging an investigation.
The first hypothesis in an investigation may be
little more than an educated guess. Accepting
the first plausible-sounding hypothesis without
empirical support is no different than brainstorm-
ing and declaring the favorite candidate cause to
be the problems true root cause.
Using available data to brainstorm and find a
tentative hypothesis, however, doesnt need to be
a problem if empirical data are used to verify it.
Jeroen de Mast assures us that hypothesis gen-
eration is speculative in nature, and the pursuit
of objectivity or certainty is inappropriate in this
context. He says objectivity and correctness are
guaranteed by the way hypotheses are tested
and verified.2
No matter how plausible a hypothesis might
sound, it cant be simply accepted without the
support of empirical evidence. A good hypothe-
sis, however, has a better chance of being correct.
Willard Van Orman Quine and J.S. Ullian offer five
virtues of a good hypothesis:3
1. Conservatism.
2. Modesty.
3. Simplicity.
4. Generality.
5. Refutability.
A hypothesis that fulfills all of these virtues
would be simple, general and make few assump-
tions, and it shouldnt contradict what is already
known to be true. It also should be possible to
test the hypothesis.
Strive for conservatism
A hypothesis may have to conflict with some of
our previous beliefs, but the fewer the better, de
Mast wrote,4 because conflicting beliefs must be
rejected or revised if the hypothesis is correct.
This requires more work because forming the
hypothesis in this case must disprove what is
No matter already known or believed to be true.
how plausible Suppose a team investigating scratches on
a hypothesis a machine units housing hypothesized they
might sound, occurred during transport. The team believed,
it cant be simply however, the packaging was sufficient to pro-
accepted without tect the housing during transport. The belief
the support that the packaging was sufficient would need
of empirical to be discarded if scratches did happen during
evidence. transport.
26 QP May 2017 qualityprogress.com
A second possible belief could be that the
incoming inspection would have detected the
scratches if they were present after transport.
Now, the hypothesis would need to contradict
two previously held beliefs, and this makes the
hypothesis less likely to be correct.
Changing beliefs due to information isnt a
problem. The likelihood of the hypothesis being
correct, however, decreases as the number of
conflicting beliefs increases. A good hypothesis is
conservative when it conflicts with the least-pos-
sible number of previously held beliefs. This virtue
may not always be necessary, such as when there
are no pre-existing beliefs for the hypothesis to
contradict.
Modesty with Occams razor
A hypothesis should be modest. A hypothesis
is more modest than another if it is weaker in a
logical sense, wrote Amos Tversky and Daniel
Kahneman.5 A modest hypothesis makes few
assumptions, and a hypothesis has a bet-
ter chance of being correct if it makes fewer
assumptions.
Consider this hypothesis: Parts were rusted
in the warehouse because they were wet with
coolant when sent there. They were wet because
the machine that blows off the coolant was not
set properly. The machine was not set properly
because the work instruction was not clear.
This may be the actual chain of causality, but
starting from the final effect and reasoning back-
ward can result in too many assumptions. Only
one assumption needs to be wrong to break this
chain of causality. Each item could be an individ-
ual, separate hypothesis to investigate, but the
entire chain would be weak as a hypothesis.
The problems with a complex hypothesis
are well-illustrated by Tversky and Kahnemans
Linda problem:
Linda is 31 years old, single, outspoken and
very bright. She majored in philosophy. As a
student, she was deeply concerned with issues
of discrimination and social justice, and also
participated in anti-nuclear demonstrations.6
The authors asked if it is more likely that Linda is a
bank teller, or both a bank teller and feminist.
Based on the description, it would be easy to
imagine Linda is a feminist, so many people con-
clude she is a bank teller and a feminist. The odds
of Linda being a bank teller, however, are higher
than the odds of Linda being both a bank teller
and a feminist.
Think of it this way: If the odds of Linda being
a bank teller are 40%, and the odds of Linda
being a feminist are 70%, the odds of Linda being
both a bank teller and a feminist are only 28%,
while the odds of her being a bank teller are still
40%. The more complex hypothesis (Linda is a
bank teller and feminist) requires more assump-
tions that must be true for the hypothesis to be
correct.
There is a simple solution to the problem of
overly complex hypotheses: Occams razor, which
states that when faced with two hypotheses that
explain the data equally well, you should choose
the simpler.7 The hypothesis that makes fewer
assumptions is more likely to be correct than one
that makes many assumptions, as illustrated in
the Linda problem.
This does not mean additional assumptions
cant be evaluated as different hypotheses. One
of many hypotheses could and should be correct.
Combining the assumptions into one convoluted
hypothesis, however, risks the hypothesis being
wrong.
Keep it simple
Modesty in a hypothesis transitions into simplic-
ity.8 A hypothesis should be simple in that it does
not go far beyond the data at hand.
Suppose parts are being detected with a devi-
ation in length. The hypothesis that the operator
needs retraining would not be a simple hypothe-
sis without any prior evidence of operator training
being related to the problem.
It would make more sense to use the simpler
hypothesis that a setting on the cutting machine
is wrong. If the setting on the machine is wrong, a
new hypothesis could be that the operator made
a mistake. Only if the second hypothesis is correct
would the hypothesis that the operator needs
retraining be appropriate.
Even then, the second hypothesis should
be evaluated because there could be other
reasonssuch as an incorrect work orderto
explain why a well-trained operator might
make a mistake. Simplicity in a hypothesis can
be achieved by avoiding extrapolating too far
beyond the data at hand.
TA B L E 1
5 virtues of a hypothesis as applied
to root cause analysis
Virtue Description
Conservatism Should conflict with few pre-existing beliefs.
Modesty Should make few assumptions.
Simplicity Does not go far beyond the data at hand.
Generality Applies to a wider range of situations.
Refutability Must be testable.
Source: William Van Orman and J.S. Ullian, The Web of Belief, 10th edition,
McGraw-Hill Education, 1978.
Generality is preferable
A general hypothesis is one that applies to a wide
range of situations.9 The virtue of generality is
more applicable to hypothesis-forming in science,
but it does have some relevance to RCA.
Although a hypothesis should be simple and
modest, it also must be general enough to be
applied. A hypothesis that is valid only under con-
trolled test conditions, for example, would not be
useful for an RCA in which the failure is happen-
ing under real-world conditions.
A sufficiently general hypothesis can be used
for making predictions. A hypothesis that units
are failing due to variation, for example, leads to
the prediction that units without variation will not
fail. A hypothesis that does not make a prediction
cant be tested, and an untestable hypothesis
should not be trusted.
Refutability required
For a hypothesis to be valuable, it must be possi-
ble to refute it. An irrefutable hypothesis serves
little purpose because there is no way to tell
whether it is correct. This is comparable to Karl
Poppers falsification, which requires a hypothesis
to be falsifiable,10 meaning it must be possible to
prove a hypothesis wrong.
Popper believed a hypothesis also can be dis-
proved at a later date if more evidence becomes
available and a new hypothesis is supported by
much corroborating evidence.
A hypothesis can be refuted by testing it.
John R. Platt recommended, Devise a crucial
qualityprogress.com May 2017 QP 27
F E AT U R E
ROOT CAUSE ANALYSIS
experiment that excludes, if possible, other hypothe-
ses.11 An experiment may be complex and expensive,
but it doesnt always need to be.
For example, consider an accelerometer, which is a
small device that generates a signal based on move-
ment. An investigator analyzing the failure of multiple
accelerometers hypothesized that they were failing
due to a dent in the casing, which was caused by the
mounting screw.
This hypothesis was refuted easily by intention-
ally denting the case of a functioning accelerometer
with a hammer. The device functioned even with a
large hammer dent, and the screw dent hypothesis
was quickly rejected. Had the hypothesis not been
rejected so quickly, more time and resources may
have been spent investigating a potential failure
cause that was not the actual cause.
The five virtues
The five virtues of a hypothesis (see Table 1, p. 27)
should be applied when forming a hypothesis during
an RCA. It is possible these virtues will conflict with
one another. When this happens, the highest priority
should be based on refutability. It does not matter
how conservative, modest, simple and general a
hypothesis is if it cant be refuted.
The virtues of modesty and simplicity help to ensure
the hypothesis is correct, so they also should be priori-
ties when forming a hypothesis during an RCA.
The virtues alone cant ensure a hypothesis is
correct. Proper application of these virtues, however,
can lead to a more robust hypothesis that can push
the analysis forward. New knowledge will be gained as
each hypothesis is evaluated.
This knowledge may include the problems root
cause, or it may simply be knowledge of what isnt the
problems root cause. Such negative knowledge can be
helpful because the investigation no longer must dig
deeper into what has been found to be a dead end.
Observations made while evaluating the hypothe-
sis also may be useful in forming a new hypothesis. A
new hypothesis should be formed after the previous
Matthew Barsalou is a statistical problem resolution Master
Black Belt at BorgWarner Turbo Systems Engineering GmbH in
Kirchheimbolanden, Germany. He has a masters degree in business
administration and engineering from Wilhelm Bchner Hochschule
in Darmstadt, Germany, and a masters degree in liberal studies from
Fort Hays State University in Hays, KS. Barsalou is an ASQ member
and holds several certifications.
28 QP May 2017 qualityprogress.com
hypothesis has been rejected. The new hypothesis also
should conform to the five virtues, and it also may be
ultimately rejected and replaced with a new hypothesis.
George E.P. Box, Stuart Hunter and William G. Hunter
referred to the process of hypothesizing and evaluating
as the iterative-inductive-deductive process.12 New
knowledge will be gained as the process repeats. Each
cycle of hypothesizing and evaluating should bring the
RCA investigator closer to the root cause.
A good hypothesisone in conformance with the
five virtuesdoes not guarantee the hypothesis will
be correct. It will, however, provide the RCA investiga-
tor a starting point for the investigation.
Remember, many hypotheses may be needed
before the root cause is found. There is no shame in
rejecting a strong hypothesis because it is unsup-
ported by a test; the final objective is the root cause
of the problem and not simply a good hypothesis.
A good hypothesis, however, can help lead the
investigator to the cause.
REFERENCES
1. Peirce Edition Project, ed., The Essential PeirceSelected
Philosophical Writings, Volume 2 (1893-1913), Indiana
University Press, 1998.
2. Jeroen de Mast, Integrating the Many Facets of Six Sigma,
Quality Engineering, 2007, Vol. 19, No. 4, pp. 353-361.
3. Willard Van Orman Quine and J.S. Ullian, The Web of Belief,
10th edition, McGraw-Hill Education, 1978.
4. de Mast, Integrating the Many Facets of Six Sigma, see
reference 2.
5. Ibid.
6. Amos Tversky and Daniel Kahneman, Judgments of and by
Representativeness, which appears in Daniel Kahneman,
Paul Slovic and Amos Tversky, eds., Judgment Under
Uncertainty: Heuristics and Biases, Cambridge University
Press, 1983.
7. Carl Sagan, The Demon Haunted World: Science as a Candle
in the Dark, Ballantine Books, 1996.
8. de Mast, Integrating the Many Facets of Six Sigma, see
reference 2.
9. Ibid.
10. Karl Popper, The Logic of Scientific Discovery, Routledge,
2007.
11. John R. Platt, Strong Inference, Science, Vol. 146, No. 3,642,
1964, pp. 347-353.
12. George E.P. Box, Stuart Hunter and William G. Hunter, Statistics
for Experimenters: An Introduction to Design, Data Analysis and
Model Building, second edition, John Wiley & Sons, 2005.
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F E AT U R E
STATISTICS

Are These
The Same?
Examining the need for equivalence testing in the verification
of a new product design | by Liem Ferryanto

30 QP May 2017 qualityprogress.com

How can we prove the performance of a newly designed
product is equivalent to the performance of a standard,
already-available product or a new-performance target? How
do we verify that the life of a newly designed, lightweight and
slim smartphone battery, for example, is equivalent to the life of
the heavier battery currently on the market?
Traditional hypothesis testing looks for differences, but if we
need to prove equivalence, we need a different type of test.
Equivalence testing is a method sometimes used in industries
regulated by the U.S. Food and Drug Administration, but it can
apply to any new product design. It is done during design veri-
fication and completed prior to the design being transferred to
manufacturing.
Equivalence testing is reviewed by specialists and cross-func-
tional teams within the design and final development stage to
confirm the design or to detect and correct any deficiencies early
on. In executing equivalence testing in design verification, manu-
facturers establish techniques based on a valid statistical rationale.

Traditional hypothesis testing

In the verification phase, manufacturers must demonstrate the
performance of a product is good enough to meet its target with
a specific confidence level while staying within its specification.
It therefore is assumed that the requirements have not been met
unless testing demonstrates otherwise.
The common statistical test used to demonstrate product per-
formance is the null hypothesis significance test (NHST). NHST
is a method used to test the quality level
that would be accepted (such as 95% of Just the
the time) by estimating a performance of Facts
the product population through a sample.
The NHST is set up like this: Design verifi-
cation using
hypothesis testing
H 0: ND SD = 0 vs. HA: ND SD 0 looks for differ-
ences between
two designs.
The null hypothesis, H 0 , means the new
design is good. The alternative hypothe- Just because
a hypothesis
sis, HA , means the new design is rejected. test shows two
ND is the mean of product performance designs arent
different does not
collected from the newly designed mean they are the
productsthe mean daily lives of a new same.
lightweight smartphone battery, for exam- Equivalence
ple. SD is a mean of product performance testing using a
two one-sided
collected from standard or targeted avail- test ensures a new
able products in the market. design is the same
or better than one
Under traditional hypothesis testing, we currently on the
assume the null hypothesis, so we assume market.
a statement such as, There are no mean

qualityprogress.com May 2017 QP 31

 F E AT U R E
STATISTICS

differences of the new batterys life and the life of a stan- designs are the same.
dard battery on the market, is true right from the start. Just because there is Traditional hypothesis
In practice, the difference is small and has no practical not enough evidence tests are designed to prove
significance but will virtually never be zero. We then col- to prove the designs there is a difference; they are
lect data to reject the null hypothesis. Figure 1 shows how are different does not designed to prove the
NHST works as the single two-sided test. As the sample not automatically two designs are the same.
size in NHST increases, the test will inevitably show a mean the designs are So, if we want to claim they
difference between the two samples. This will reject the the same. are equivalent, we need a
determination that the new design meets its target (H 0) different hypothesis test.
because the confidence intervals collapse as the area of It is not enough to do the
H 0 decreases (two broken lines in Figure 1) and the area of traditional hypothesis test and just not reject.
HA increases when the sample size increases. Also, its commonly known that as the sample size
In many cases, when the test shows the null hypothesis increases, the NHST will inevitably show a difference
is not rejected at the certain alpha () significance level between the two samples because the confidence intervals
(for example, 5%), or 1 (95%) confidence level, we are collapse as the sample size increases.
content or even happy. In reality, we want to find signifi-
cance and also show the performance of a newly designed Equivalence testing
product is on target. Verification of a newly designed product is done to demon-
When we do not reject the null hypothesis, however, strate there is no practically or functionally significant
what can be said about the design performance means? difference between a new product designs performance
Failure to reject the null in the NHST shows there is no and its standard or target. The study is designed with
statistically significant evidence the means are different. the desired outcome being equivalence in efficacy, while
Without more information, we usually consider these long-term adverse effects (such as safety and health),
groups equivalent, but this is based on the idea that we are robustness, quality or costs may be demonstrated to be
looking for evidence they are different. advantageous for the new product design.
The typical method of traditional hypothesis testing Examples of the use of equivalence testing include:
that looks for differences between groups does not ++ The lifetime comparison of data from a newly designed
technically allow us to conclude equivalence just because lightweight battery for a smartphone to the existing
we do not reject null due to absence of evidence.1 In other batteries on the market or to new lifetime target.
words, just because there is not enough evidence to prove ++ Efficacy of compression force between products
the designs are different does not automatically mean the designed from material A and material B.
++ A study of shipments of temperature-sensitive products
using insulated packaging (new design) and packed in
FIGURE1 dry ice (existing design) to measure effectiveness and
robustness.
NHST as single 2-sided test If manufacturers want to demonstrate how well their
newly designed product performs, they must first assume
the requirements have not been met and then try to gather
evidence to the contraryevidence that suggests the prod-
Probability of occurrence

0.4
uct is at least equivalent to the targeted requirements:2
0.3
New design New design H 0: ND SD vs. HA: ND = SD
0.2 doesnt meet doesnt meet
its target: its target:
HA: ND SD 0 HA: ND SD 0 If the performance difference between the two
0.1 products is small, then the difference has no practical
New design
meets its target: significance or impact on the customer. Then, if and only
H0: ND SD = 0
0 if the difference in performance is small, the two products
6 4 2 0 2 4 6
are functionally equivalent, which means that the function
Product performance
of both products perform with no significantly different
NHST = null hypothesis significance test impact on the customer. We incorporate the difference

32 QP May 2017 qualityprogress.com

into the hypothesis structure as follows:
H 0: ND SD < and ND SD > + (not equivalent) If the test doesn't reject the null hypothesis, we can't
vs.
HA: < ND SD < + (equivalent) when the hypothesis is false indicates the power of the
The threshold delta () represents a range of difference
that is not large enough to have any clinical or functional
implications. The idea is that small differences in product
performance are not always functionally important.
In many cases in early product development, we know
the target of our product performance, but we rarely know
its specification until after our manufacturing capability in
producing the product is developed.
If the specifications are known in advance, delta must be
smaller than the original specification so the entire distri-
bution of the new product performance still falls within
specification. The delta must capture the probability of in
product performance risk at the certain significance level
that may cause some dissatisfaction or harm to users if the
product performance does not conform to its specification.
We can now restate H 0 as follows:
H 0-1: ND SD < and H 0-2: ND SD > +
to reject or pass the equivalency (HA: < ND SD < +, or
the area between broken lines), respectively.
claim equivalency. The probability that the test will reject
TOST. This probability increases with sample size. We want
this to happen, but it might not reject the null if the sample
size is too small, therefore sample size is important.
Sample size calculation also depends on the effect size,
such as the ratio between delta and standard deviation.
Choose a sample size between 30 to 50 samples for each
group to have good test power (>80%), but beyond that is
probably an unnecessary use of resources.3 Larger samples
are needed if the effect size is small.
The appropriate statistical method to verify a new
designs product performance is therefore to use equiva-
lence testing in the following six steps:
1. Determine the equivalence value, delta (), so that if
FIGURE2
Equivalence test designed to reject

To prove equivalency of two designs, we reject H 0-1 to

a null regarding a difference
That is, ND SD < , then to reject a difference of the
determine the difference of two product performances opposite kind, that is, ND SD > +. Having rejected both, the
is larger than the minimum allowable difference (). We small difference < ND SD < + is the negligible effect size.
reject H 0-2 to determine the difference of two product
performances is smaller than the maximum allowable
0.4
difference (+). If we reject both of these hypotheses, then
the difference falls between the minimum and maximum 0.3
allowable difference. 0.2
H0 1: ND SD <
In practice, the difference will almost never be zero. We HA 1: ND SD >
0.1
then can say that the difference is small and has no practi-
Probability of occurrence

cal significance or no significantly different impact on the 0

customers who use the product. 0.4
This leads to the most basic form of equivalence 0.3
testingthe two one-sided test (TOST) shown in Figure 2 0.2
which means we essentially must compute TOST statistics. H0 2: ND SD > +
HA 2: ND SD < +
0.1
Because we perform a series of tests, we must reduce the
error in each individual test so the cumulative error of the 0
overall result is still within the alpha significance level. 0.4
HA:
We declare the two group means equivalent at the delta < ND SD < +
0.3
level if and only if both are rejected. If, under a certain
0.2
confidence interval, the difference is completely contained H0 1: ND SD < H0 2: ND SD > +
in the interval with endpoints and +, then we declare 0.1
equivalence. Unlike classical testing, we want to be able 0
to say the difference is very likely zero (beyond random 6 4 2 0 2 4 6
Product performance +
chance). If the delta decreases or increases, the test tends

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F E AT U R E
STATISTICS

ND SD < and ND SD > +, the means will be TA B L E 1

Lifetime data of 30 batteries

considered equivalent.
2. Determine the signicance level () of the test, such as
= 5%.
3. Gather data to calculate sample means and standard Obtained from validation testing of two groups of
deviations. designs and the capabilities of each designs.
4. Construct the 100(1 /2)% lower confidence interval for
Mean Standard SNR (/
ND SD < , and the 100(1 /2)% upper confidence Sample size (hours) deviation Cpk standard
level for ND SD > + . For example, if we want to be (hours) deviation)
5% or overall confidence to be 95%, then use /2 = 2.5% Standard 18.45 0.35 4.23 52.71
design= 30
significance, or 97.5% confidence interval, for each of
TOST, and overall, is 5%, for 95% confidence. New design = 30 16.10 0.15 4.66 107.33
5. If the interval is contained entirely between and +,
SNR = signal to noise ratios
then ND and SD can be declared equivalent at the level
of signicance.
6. Test basic capability (C pk) of the design if the specifi-
cations are known, or test robustness by comparing equivalence test rejects
the signal-to-noise ratios (SNR), so poor processes or the null hypothesis that ND Market data show
capability should not be approved even if delta passes SD > 2.5 and ND SD smartphone users
the hypothesis tests. < 2.5 by comparing these are satisfied if their
t-statistics with the critical daily battery life is
Case study values at the 2.5% level. at least 14 hours per
Consider the verification of the daily life (after being fully Thus, we can conclude the day for normal use
charged) of a newly designed smartphone battery. The two designs are equivalent after the battery is
battery is equivalent to the heavier battery currently avail- at a 95% confidence level fully charged.
able on the market, but the new design is more lightweight because 2.23 hours < ND
and slim. SD < 2.47 hours, which is
Market data show smartphone users are satisfied if their contained entirely between 2.5 hours and +2.5 hours.
daily battery life is at least 14 hours per day for normal ++ With a traditional NHST, such as one two-sided,
use after the battery is fully charged. The data with 95% two-sample t-test, H 0: ND = SD and HA: ND SD with
confidence level also reveal users dont notice a 2.5-hour 95% confidence level, we can obtain the results shown
difference in battery life. in Table 4. The NHST rejects the null hypothesis that SD
The test results from 30 batteries of each group are = ND as the p-value < 0.05 and concludes that average
shown in the second and third columns of Table 1. The data performance of a new design among the samples is sig-
came from a normal and stable manufacturing process. nificantly different from the performance in the standard
We can say that if the difference of battery life is = 2.5 group at a 95% confidence level, as 2.2094 < ND SD <
hours, the quality of both battery lives is equivalent. We can 2.4906, which does not contain zero value.
run this test using TOSTs in Minitab for equivalence testing The result from the NHST gives a different conclusion
as the following: from the one obtained from the equivalence test method,
++ For a one-sided, two-sample t-test for H 0: ND SD < which is more appropriate for performing verification
2.5 with 97.5% confidence level, or = 2.5%, and HA: ND of a newly designed product. Using a traditional com-
SD > 2.5, we obtain the results shown in Table 2. The parative test to ensure a product is properly functioning
test rejects the null hypothesis that ND SD < 2.5 as and meeting specified application, intended use and
p-value = 0, which is less than = 0.025. safety requirements could frequently lead to incorrect
++ For a one-sided, two-sample t-test for H 0: ND SD > 2.5 conclusions.
with 97.5% confidence level, or = 2.5%, and HA: ND SD
< 2.5, we obtain the results shown in Table 3. The test Incorporating equivalence
rejects the null hypothesis that ND SD > 2.5 as p-value testing in process capability
= 0.019, which is less than = 0.025. Because users are satisfied if their daily battery life is at
++ From the two one-sided, two-sample t-tests, the least 14hours per day for normal use after the battery is

34 QP May 2017 qualityprogress.com

TA B L E 2 TA B L E 3 TA B L E 4

One-sided 2-sample One-sided 2-sample Traditional NHST

t-test for H 0 t-test for H 0 One two-sided 2-sample t-test,
H0:ND = SD and HA: ND SD with 95%
confidence level.
ND SD < 2.5 with 97.5% confidence ND SD > 2.5 with 97.5% confidence
level or =2.5%, and HA:ND SD > 2.5. level or =2.5%, and HA:ND SD < 2.5. Sample N Mean StDev SE mean

Sample N Mean StDev SE mean Sample N Mean StDev SE mean 1 30 18.450 0.350 0.064

1 30 18.450 0.350 0.064 1 30 18.450 0.350 0.064 2 30 16.100 0.150 0.027

2 30 16.100 0.150 0.027 2 30 16.100 0.150 0.027 Difference = mu (1) mu (2)

Difference = mu (1) mu (2) Difference = mu (1) mu (2) Estimate for difference: 2.3500

Estimate for difference: 2.3500 Estimate for difference: 2.3500 95% CI for difference: (2.2094, 2.4906)

95% lower bound for difference: 2.2329 95% lower bound for difference: 2.4671 T-test of difference = 0 (vs not =):
T-value = 33.80; P-value = 0.000;
T-test of difference = 2.5 (vs >): T-test of difference = 2.5 (vs <): DF = 39.
T-value = 69.76; P-value = 0.000; T-value = 2.16; P-value = 0.019;
DF = 39. DF = 39. CI = confidence interval
DF = degrees of freedom
DF = degrees of freedom DF = degrees of freedom mu = mean
mu = mean mu = mean N = sample size
N = sample size N = sample size NHST = null hypothesis significance test
SE = standard error SE = standard error SE = standard error
StDev = standard deviation StDev = standard deviation StDev = standard deviation

fully charged, this value can be set as the lower specifica-
tion limit of the battery life. We can then calculate the Cpk
with a one-sided specification as the ratio between the dif-
ference of the mean and the lower specification limit (LSL),
which is 14 hours, to three standard deviations.4
The Cpk results of the designs are shown in Table 1. Cpk for
the new design and the standard design are 4.23 and 4.66,
respectively. These results show the new design is capable
relative to the specifications and as good or even better
than the standard design. The robustness, as measured by
their SNR, is also better for the new design (SNR = 52.71)
than the standard design (SNR = 107.33).
If the LSL were 16, Cpk for the new and standard designs
would be 0.22 and 2.3, respectively. Apparently, the new
design was not capable but still would pass the TOST. In
this example, if the manufacturers had started production,
they would have had a very high percentage of rejected
batches because the new process was simply not capable.
This shows the inherent weakness of the TOST method
when it is applied as a standalone test. It is incorrect to
accept a new design if the test acceptance standards are
not set right in the first place.
This example also shows the sensitivity of the delta.
If it is too wide, it will accept processes that should not
be approved, even if it passes the hypothesis tests. So,
to make a TOST meaningful for the verification of a new
product design, it must always be supplemented with basic
capability tests.
This ensures poor processes are not approved and pre-
vents rejected products, which can cost millions of dollars
per year and lead to product shortages due to an inability
to ship.
REFERENCES
1. Douglas G. Altman and J. Martin Bland, Absence of Evidence Is Not
Evidence of Absence, British Medical Journal, Aug. 19, 1995, pp.
311-485.
2. Scott Pardo, Equivalence and Noninferiority Test for Quality,
Manufacturing and Test Engineers, CRC Press, 2014.
3. Carmen R. VanVoorhis and Betsy L. Morgan, Understanding Power
and Rules of Thumb for Determining Sample Sizes, Tutorials in
Quantitative Methods for Psychology, Vol. 3, No. 2, 2007, pp. 43-50.
4. Richard E. Devor, Tsong-how Chang and John W. Sutherland,
Statistical Quality Design and Control: Contemporary Concepts and
Methods, Macmillan Publishing Co., 1992.
Liem Ferryanto is the director of
technical continuous improvement
at Applied Materials in Santa Clara,
CA. He has a doctorate in industrial
statistics from Technische Universitt
Kaiserslautern in Germany. Ferryanto is
a senior member of ASQ.

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36 QP May 2017 qualityprogress.com

 Newfor Tricks
an Old Tool
Introducing marginal risk and the risk sensitive
priority number to FMEA | by Eugene R. Bukowski

Failure mode and effects analysis (FMEA) is a popular risk assessment

tool used to manage potential process and design risk. Not surpris-
ingly, there might be failure modes associated with the activity of
conducting an FMEA.
Accurate results require accurate input rankings, but
complete and accurate information is not always
available. When FMEA input rankings are
based on collective intelligence that are
skill-based and sometimes subjec-
tive, there must be a method of
assessing the sensitivityitized
risk associated with ranking
uncertainty.
Just the There is an out
Facts
Its possible for
input rankings of a
failure mode and
effects analysis
(FMEA) to be
underestimated,
resulting in a low
risk priority num-
ber (RPN).

Calculating the
RPNs sensitivity
to input ranking
errors and the
marginal risk
resulting from
these errors
allows for a
more accurate
FMEA and better
risk-mitigation
decision making.

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 F E AT U R E
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There is an outcomes-based solution for FMEA practi-
tioners to accomplish this, and it involves introducing the
concepts of marginal risk and risk sensitivity to the current
FMEA practice. This approach:
++ Offers immediate utility by providing additional
insight that helps teams make better decisions for risk
mitigation.
++ Clearly identifies potential failure modes and risk assess-
ments that might be sensitive to marginal change related
to input ranking uncertainty.
++ Illuminates the critical-few risk sensitive priority num-
ber (RSPN) values versus the many less-sensitive risks
already mitigated sufficiently.
++ Might allow teams to rationalize a lower frequency for
refreshing the FMEA for many less-sensitive risks.
++ Leverages the standard FMEA spreadsheet to clarify
marginal risk by using a few simple formulas and two
easy column additions.
Using FMEA and the RPN to mitigate risk
FMEA has been used since the mid-1960s when it was first
introduced by the aerospace industry. It is a popular tool
because it offers a proactive approach to risk mitigation,
which can prevent potential quality problems. FMEA might
be used in a variety of applications involving processes,
products and services. It is often used to develop manufac-
turing process controls.
For production processes, the tool guides the user to
dissect and document the process, identify potential failure
modes, assess current risks associated with failure modes,
prioritize potential failures based on relative risk and take
action to mitigate high potential risk. When revisited and
refreshed periodically, it becomes an effective catalyst for
continuous improvement.
Failure modes are the manner in which a design or
process could potentially fail to meet the design intent or
process requirement. It is a description of a nonconfor-
mance in a particular operation. The effect a failure might
have on a customer is key, and it is described in terms of
something the customer might notice or experience. The
cause or mechanism of failure describes how it is physically
possible for the failure mode to occur.
FMEA teams could make decisions based on a risk prior-
ity number (RPN), which is the product of three factors that
take on discrete rankings. The three variables use standard
ranking scales often ranging from one to 10. A ranking of
one is most favorable (low risk), and a score of 10 is least
favorable (high risk).
Severity (Sev) characterizes what level of impact the
effect could have on the customer. Occurrence (Occ) rep-
resents the frequency of the mechanism of failure or cause.
Detection (Det) indicates how well the current process
controls can detect a process weakness. Process controls
might detect both defects and the process errors that
cause defects.
The RPN value is easily formulated using any spreadsheet
tool. A spreadsheet formula for RPN will resemble:
RPN = Sev * Occ * Det
Spreadsheet templates for FMEA come in a variety
of forms. It is acceptable for the ranking criteria to vary
from one application to another and from one analysis to
another, as long as the standards are documented and
remain consistent within a single FMEA. For the 10-point
scale, the lowest possible RPN value is equal to one (= 1 1
1) and the highest possible value is equal to 1,000 (= 10
10 10).

TA B L E 1

Partially completed row from an illustrativeFMEA

Potential Potential cause(s)/
Process Potential Current process
effect(s) Sev mechanism(s) Occ Det RPN
function failure mode controls
offailure offailure
Driving to a Car from
destination opposite Head-on
on a two-lane direction collision Driver distraction
undivided crosses into at 55 mph
highway your lane

Sev = severity FMEA = failure mode and effects

Occ = occurrence analysis
Det = detection RPN = risk priority number

38 QP May 2017 qualityprogress.com

Potential failures of FMEA TA B L E 2

Potential FMEA tool failure modes

Conducting an FMEA sometimes can be more challenging
than what is inferred from the instructions. Consider the
partially completed entry from an illustrative FMEA shown
in Table 1. Nearly everybody is familiar with the process (Not intended to be a complete list)
of driving and staying in your lane, which has become a
metaphor to describe the avoidance of overreaching ones
own bounds. Potential failure Potential effect Potential cause
mode of failure
One important failure mode while driving on a two-lane
Inadequate Insufficient customer focus
undivided highway is when a car from the opposite lane or incomplete Unrecognized
crosses over into your lane. Potentially, this can cause a FMEA and
documentation unmitigated Improper identification of the
head-on collision at 55 mph. There are several potential (failure to be risk mechanism of failure
causes for this failure mode, one of which is driver dis- comprehensive)
traction. In many cases, the only process control is visual Severity is scored based on
identification using the painted yellow line between lanes. failure mode (incorrect) rather
than effect of failure (correct)
Usually, such detection provides more anxiety than conso-
Subjective correlation of
lation to customers of the highway. severity with occurrence and/
Even when presented to groups that have the necessary or detection
skills to use the FMEA tool independently, the RPN results Occurrence is scored based
can vary significantly. These observations might indicate on effect of failure (incorrect)
rather than mechanism of
the tool depends on the prerequisites of clear standards, failure (correct)
Inaccurate RPN
meaningful instructions, effective training and the partici- value (failure to Unmitigated Probability of detection is
pation of process subject matter experts. be accurate and risk overestimated
objective)
You might perform an FMEA to identify failure modes Detection score is based on an
related to conducting an FMEA. Such analysis immediately ambiguous customer
suggests a potential failure mode related to inadequate or Subjective correlation of
incomplete FMEA documentation. detection with occurrence
There is a chance the team might omit potential failure Detection score is improved
byusing more visual
modes, their potential effects on particular key customers inspection alone
and potential causes. The potential effect this might have
Detection score is improved by
on the organization is unrecognized or unmitigated risk using random quality checks
because the FMEA team might fail to recognize particular
key process risk and thereby fail to take appropriate action. FMEA = failure mode and effects analysis
Potential causes for this failure mode are listed in Table 2.
Insufficient customer focus is one mechanism of failure
that might cause inadequate FMEA documentation. When
an embedded operation focuses too much on the end user, ones sunglasses, for example, is not a mechanism of
for example, you can lose focus on the customer at the next failure when a car from the opposite lane crosses over into
stage of operation. your lane. Environment is not an adequate description
It can be problematic when a team is willing to deliberate because it is too vague. Specifically, sun glare can be a
at length about the needs of an end user with no actual valid cause, but not the lack of sunglasses, for which there
data from that voice of the customer (VOC) while simul- is a potential solution.
taneously dismissing the needs of the next operation step Performing an FMEA or using the FMEA tool also sug-
when firsthand VOC data is within walking distance. gests a potential failure mode related to inaccurate RPN
Improper identification of the mechanism of failure is values. There is a chance any particular Sev, Occ or Det
another potential cause of inadequate FMEA documen- ranking might be inaccurate, which can result in an inaccu-
tation. Causes should be described in terms of something rate RPN value.
that can be corrected or controlled. Ambiguous phrases The potential effect this might have on an organization
should be avoided. is unmitigated risk because the FMEA team might under-
The absence of a solution is not a cause. Forgetting estimate a particular key risk and fail to take appropriate

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 F E AT U R E
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action. Potential causes for this failure mode are also listed
in Table 2.
Sev is intended to focus on the customer. Sev applies
only to the potential effect the failure could have on the
customer, but some confuse effect of failure with potential
failure mode. Using the potential failure mode to score
Sev is misguided and most often will underestimate risk
because it alone does not comprehend the effect on the
customer.
Sev should be determined independent of Occ and Det.
It is incorrect to suggest Sev automatically improves as the
result of advancement in Occ or Det. Grooved pavement
under the yellow centerline on a highway offers an audible
alarm, which improves Det for the distracted driver, but
the potential effect of failure still remains a possibility and
death still remains the worst-case scenario. Therefore,
Sev does not improve along with Det as a result of adding
grooved pavement.
Occ is intended to focus on the mechanism of failure
or cause. Developing a ranking for Occ is best performed
with actual data, but good data is not always available or
practical. Occ applies only to the frequency of the cause,
but some confuse cause with effect of failure.
Using the effect of failure to score Occ most often will
underestimate risk because the frequency of the effect
is less than or equal to the frequency of the cause. The
frequency of an actual head-on collision caused by driver
distraction, for example, is less than the frequency of all
occasions of driver distraction. Driver distraction occurs
much more often than many want to admit.
The capability of process controls to detect failures is
easily overestimated when using FMEA because estimates
can be somewhat subjective. Det is intended to focus on
the likelihood that the existence of a defect will be detected
by process controls before it leaves the operation.
Process controls that aim to detect failures after they
occur should have less-favorable rankings than those that
can detect failure mechanisms and prevent defects before
they occur.
Defects might be thought of as individual harmful risk
reserves. It is therefore remarkable when a team is willing
to assign an initial favorable ranking for Det when process
controls rely on some form of downstream inspection
beyond the control of the operation under analysis.
Det rankings are intended to focus on current capabil-
ities of process controls within ones own operation. The
customer at the next stage of the operation must be con-
sidered in all risk assessment that includes Det.
A Det ranking should not be made more favorable just
because a related Occ ranking has improved. Consider, for
example, when a government entity conducts a no texting
while driving awareness campaign. Perhaps studies can
demonstrate a change in driver behavior that results in an
actual decrease in the frequency of driver distraction. This
might improve the Occ ranking for driver distraction.
The capability of process controls to detect and ticket
texting drivers, on the other hand, remains unchanged,
therefore the success of the awareness campaign should
not influence the Det ranking. Process controls remain
muted by police force capacity.

TA B L E 3

Example of how potential marginal error affects RPNvalue

Potential
Potential Current
Process Potential cause(s)/
effect(s) Sev mechanism(s) Occ process Det RPN
function failure mode offailure controls
of failure
Driving to a Car from
destination opposite Head-on Driver Visual No
on a two-lane direction collision 10 8 1 80
distraction identification action
undivided crosses into at 55 mph
highway your lane
Marginal error 100
Driving to a Car from
destination opposite Head-on Driver Visual Action
on a two-lane direction collision 10 8 2 160 required
distraction identification
undivided crosses into at 55 mph
highway your lane

Sev = severity Det = detection

Occ = occurrence RPN = risk priority number

40 QP May 2017 qualityprogress.com

 Although visual inspection and random quality checks
have their purposes, these forms of process control have
limited impact on the Det ranking for risk assessment. Nei-
ther can detect the mechanism of failure to systematically
prevent all failures.
When defects are created, eventually some will find a
way to escape the operation and reach the customer. When
visual inspection acts as the only method of Det, the prob-
ability of detecting failures before they leave the operation
remains limited.
Adding a third or a fourth human visual inspector, for
example, might not actually improve the probability that
visual inspection alone will detect significantly more fail-
ures. Random quality checks are unlikely to detect isolated
defects and should not influence the Det ranking.
A potential effect of an inaccurate RPN value is unmit-
igated risk because an FMEA team might underestimate
particular key risks and fail to take appropriate action.
Some organizations still employ an arbitrary RPN threshold
value beyond which action is required and below which no
action is needed.
It is important to note that recent industry thought
leadership does not recommend the use of an RPN thresh-
old to initiate the need for action. Inaccurate RPN values
below an arbitrary action threshold might lead teams to be
complacent with particular failure modes.
A marginal error in Sev, Occ or Det might Driver distraction
significantly decrease the RPN, perhaps occurs much more
decreasing its value below an action often than many
threshold value. Table 3 provides an illus- want to admit.
trative example of how input ranking error
might affect the RPN.
The example uses an arbitrary RPN action threshold
value of 100 and a scenario in which Sev = 10, Occ = 8, and
an inaccurate ranking of Det = 1. This results in an RPN value
of 80 (= 10 8 1). Because 80 is less than 100, the team
might defend a decision for no action.
Consider the possibility the inaccurate Det ranking
requires a marginal correction of plus one (+1) unit. By
substituting Det = 2 instead of Det = 1, the RPN value
changes from 80 to 160 (= 10 8 2). This change is further
illustrated in Table 4.
Note that this particular correction causes a 100%
increase in the RPN value. Since 160 is greater than 100,
action now would be required by the team. This is the
opposite of the previous decision.
RPN sensitivity
It is important to recognize that some RPN values are more
sensitive to input ranking errors than others. Sensitivity

TA B L E 4 TA B L E 5

Graphical example of how Partially completed RSPN/RPN

potential marginal error matrix for Sev = 10
affects RPN value 10
9
200/100
180/90
300/200
270/180
400/300
360/270
500/400
450/360
600/500
540/450
Original Marginal change 8 160/80 240/160 320/240 400/320 480/400
Sev 10 10 7 140/70 210/140 280/210 350/280 420/350
Occ 8 8 6 120/60 180/120 240/180 300/240 360/300
Det 1 Error +1 2 5 100/50 150/100 200/150 250/200 300/250
RPN 80 RSPN 160 4 80/40 120/80 160/120 200/160
Min 3 60/30 90/60 120/90

1 100 240 2 40/20 60/40

Sev = severity Det = detection 1 20/10

Occ = occurrence Min = minimum 1 2 3 4 5
RPN = risk priority number
RSPN = risk sensitive priority number
RSPN/RPN RSPN > 100/RPN < 100
RPN = risk priority number
RSPN = risk sensitive priority number

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TA B L E 6
involves the marginal relationship between dependent and
independent variables.
In general, RPN sensitivity is the recalculated RPN value Illustrative FMEA
caused by a one-unit change to any one of the three input
rankings: Sev, Occ or Det. Even when marginal error does
not decrease an RPN value below an action threshold value,
sorted by RPN values
Sev Occ Det RPN RSPN MRPN
FMEA teams still might be misguided by inaccurate action
priorities. 10 7 2 140 210 70
Sensitivity analysis can help teams understand the 9 2 6 108 162 54
effects potential input ranking errors might have on 8 6 2 96 144 48
computed risk numbers. The RSPN is one specific way
10 3 3 90 120 30
to measure the sensitivity of RPN values to potentially
9 5 2 90 135 45
inaccurate low input rankings. It is the recalculated RPN
value based on a +1 unit change to the 7 2 5 70 105 35
minimum of the three input rankings. 7 3 3 63 84 21
Of course, input This approach is designed to 8 7 1 56 112 56
rankings can be identify maximum potential increases
9 1 6 54 108 54
more than just mar- to RPN values, and it can be shown
ginally inaccurate, 7 2 3 42 63 21
that this always occurs with a mar-
meaning at times, ginal change to the minimum of the RSPN/RPN Either RSPN or RPN > 100
ranking uncertainty three input rankings. The RSPN value Sev = severity
may be more sig- easily can be formulated with any Occ = occurrence
nificant than just Det = detection
spreadsheet tool. A column for RSPN FMEA = failure mode and effects analysis
marginal. can be added right next to the tra- RPN = risk priority number
RSPN = risk sensitive priority number
MRPN = marginal risk priority number
TA B L E 7

Example FMEA template augmented with

RSPN and MRPN columns
ditional RPN column in the
FMEA template of choice. A
spreadsheet formula for RSPN
Failure mode and effects analysis (FMEA) will resemble:
Item: Drill hole Responsibility: J. Doe
RSPN = max(Sev,Occ,Det) *
Model: Current Prepared by: J. Doe
med(Sev,Occ,Det) * (1 + min(-
Core team: J. Doe (engineering), J. Smith (production), B. Jones (quality) Sev,Occ,Det))

Potential Based on the RSPN formula,

Potential Potential Current
Process cause(s)/ you can build matrixes of
failure effect(s) Sev mechanism(s) Occ process Det RPN RSPN MRPN
function mode offailure controls RSPN and RPN values based
of failure
Break on various Sev rankings. Table
Improper Operator
Drill blind Hole too through 7 machine 4 training and 3 84 112 28 5 (p. 41) shows a partially
hole deep bottom of
plate setup instructions completed RSPN/RPN matrix
for Sev = 10. This particular
Hole not Incomplete Improper Operator
deep thread 5 machine 4 training and 3 60 80 20 example assumes an arbi-
enough form setup instructions trary RPN action threshold
5 Broken drill 2 None 9 90 135 45 value of 100. These matrixes
demonstrate many scenarios
Sev = severity Det = detection RSPN = risk sensitive priority number for which the RPN is less than
Occ = occurrence RPN = risk priority number MRPN = marginal risk priority number
the action threshold value

42 QP May 2017 qualityprogress.com

concurrent with the RSPN being greater than the action
threshold value.
A more conservative team approach is to define action
plans for all RSPN values greater than the RPN action
threshold value. Teams might perform sensitivity analysis
using the FMEA tool, similar to analysis using the RSPN/
RPN matrix, simply by data sorting on the new RSPN
column. This approach can identify failure modes with
risk numbers that might be sensitive to particular input
rankings.
Table 6 shows an example of several rows from an
illustrative FMEA sorted by the RPN values from highest
to lowest, using an arbitrary RPN action threshold value
of 100. This example demonstrates several RPN scenarios
for which the sensitivity to inaccurate input rankings might
reverse the team decision from no action is defensible to
action required.
The RSPN value represents the recalculated risk number
when the FMEA team unintentionally makes a worst-case
marginal error while computing the original risk number.
Of course, input rankings can be more than just mar-
ginally inaccurate, meaning at times, ranking uncertainty
might be more significant than just marginal. The RSPN
method simply offers a standardized approach to compare
the relative sensitivity of RPN values to potential marginal
errors across multiple failure modes.
MRPN values, for example those with high Sev rankings.
Table 7 illustrates how the RSPN and the MRPN indexes
might be added to existing FMEA templates. These
columns can be hidden when not in use. Augmenting the
FMEA tool in this manner requires very little effort.
Sensitivity analysis has the potential to produce signif-
icant benefit by offering additional insight for particular
failure modes that might lead to more effective risk
mitigation.
Eugene R. Bukowski is a senior engineering
manager for General Electric Healthcare in
Noblesville, IN. He has a masters degree in
electrical engineering from Duke University
in Durham, NC, and a masters degree in
manufacturing management from Kettering
University in Flint, MI. A senior member of ASQ,
Bukowski is an ASQ-certified Six Sigma Black Belt.
The Government Excellence System

Calculating for marginal risk ing me

nt
Shap nage
In the context of the RSPN approach, the marginal risk Fut
ure
tion
Ma
ova
priority number (MRPN) is the change in magnitude of the Inn Innovation
RPN value associated with a +1-unit change to the mini- 20%
mum of the three input rankings. It is simply the difference Enablers nda
Age
between the RSPN value and the RPN value. o nal
20% Na ti
tion
s
The MRPN value easily can be formulated with any a in F
unc
ces
M ervi
spreadsheet tool. A column for MRPN can be added right ta rs S
en S nment
Sev
next to the RSPN column in the FMEA template of choice. A rt G
ove
r
Hum a
spreadsheet formula for MRPN will resemble: an Sm
Cap
Res ital
our
ces
Gov &A
sset
MRPN = RSPN RPN ern
anc sM
ana
Vision
e gem Achievement
ent
The MRPN value is significant because it represents the 60%
actual magnitude of change in the risk number based on
potential marginal error. For the 10-point scale, it can be
shown that the lowest possible MRPN value is one (1 1), Sheikh Khalifa Government Excellence Program (SKGEP)
and the highest possible value is 100 (10 10). strives through its mission statement to reach excellent
performance outcomes of the UAE public sector. SKGEP
Data-sorted MRPN values provide another form of sensitiv- has been instrumental in enhancing organizational
ity analysis for FMEA teams. This additional information might system act to induce transformational thinking in
influence teams to further mitigate risk for particular failure government initiatives, enhancing the culture of
modes. Teams might choose to reconsider the potential effec- innovation, and shaping the future of Government.

tiveness of action plans for those failure modes with higher

qualityprogress.com May 2017 QP 43

Seeking innovation through tools, techniques and approaches

Innovation mperative
PROBLEM SOLVING

Finding
Learn from the experiences
of people who suffer from the
problemwhether they are
internal or external customers
and be prepared to make a shift

Solutions
as new discoveries occur. This
is the preferred hierarchy of the
learning interface:
++ Analyze data.
++ Talk to the customer.

Creatively
++ Observe the customer.
++ Be the customer.
++ Involve the customer in the
solution.
Both internal and external
customers will express their
pain in terms of:
Collective knowledge is a powerful way ++ Cost and time.
++ Effort and emotion.
to find alternative answers
++ Risk and worry.
++ Obstacles.
by Peter Merrill
Connecting to
the solution
Albert Einstein was so insightful when he said, No problem can be solved with the Creative techniques called
same level of consciousness that created it.1 ideation or idea creation can
Typically, we start problem solving by collecting data to understand the problem, and unlock the subconscious
we process map to get a picture of the processes concerned. The shortcoming is that mind, and you become more
we analyze the data and get solutions that are within the context of the status quoa creative.
broken step in the process or an inadequate understanding of requirements. Somewhere, someone
Traditional problem solving tends to focus on immediate cause and effect. Creative probably has already thought
problem solving, on the other hand, recognizes that in a complex environment, there are of the solution youre looking
many degrees of separation of an effect from the original causes. for, but in a different con-
The innovator recognizes the butterfly effectthat is, a butterfly flapping its wings text. This means connecting
in Singapore can cause a hurricane in the Caribbean. Problem solvers in the innovation to other business environ-
process find solutions in completely new environments. ments, and networking is
Henry Ford saw meat hanging on hooks, for instance, as the transfer of material one important way of doing
between work stations. This visual gave Ford the solution to transferring car parts this. The fundamental point is
between work stations at his own factory. that breakthroughs occur at
Innovators, like Ford, must step out of the box and look for a completely new process the intersection of bodies of
compared with the present process. knowledgethe spark of inge-
nuity. That is the power behind
Defining the problem networking for collective
The first step in solving any problem is defining the problem. Quoting Einstein again, If knowledge.
I had an hour to save the world, I would spend 55 minutes defining the problem and five Another interesting fact
minutes finding the solution.2 about problem solving is that

44 QP May 2017 qualityprogress.com


there is no correlation between
intelligence and problem solv-
ing. (There is hope for us all,
thankfully.)
Scott Page, a Caltech pro-
fessor, researched this in the
1990s. He assembled a group
of Mensa-level people as well
as a group of ordinary people
he called the brown socks
group.
Both groups were given
a series of problems to
solve. The Mensa group was
repeatedly beaten by the
brown socks group, which
was diverse and had additive
knowledge. The Mensa group
had identical knowledge,
which was not additive.3 This
suggests having diversity is a
must.
There are several techniques
available to harness collec-
tive knowledge, and the best
known is brainstorming.
Ideation
Over the years, the brain-
storming process has been
developed and flows thus.
Loosening up is the first step in
creating what Edward de Bono
calls lateral thinking.4
I like to use the improvisa-
tion approach that you find
in theater. Someone makes
a statement such as, Its a
great day out there. Impor-
tantly, this is not a question.
The next person replies, Yes
and I think I will go for a
walk. A third person might
add, Yes and I think I will
wear my new shoes. And so
it continues. Each statement
builds on the previous one and
each statement is positive,
which creates a great mood of
creativity.
Research shows the average
adult thinks of three to four
alternatives for any given
problem. Get 12 to 20 people
and have them first write three
or four ideas on their own.
Then have everybody turn to
their right and share ideas with
their neighbor on that side.
Have them add ideas to their
lists. Next, have everybody do
the same with neighbors to the
left. Finally, everybody turns
back to the person to the right
and builds a final list.
From perhaps originally
struggling to find three ideas,
every pair of people now has
a minimum of 10 ideas, and
some have as many as 12 to
18. We then capture the ideas
of everyone in the room. To
be successful, it is essential
that team members listen to
others ideas. By listening well,
we allow other peoples ideas
to trigger subconscious ideas
and experiences of our own.
We will have 30 to 40 ideas
qualityprogress.com May 2017
compared to the original list of
about three per person.
The key issue with all of this
work is volume. Linus Pauling
said, The best way of having
a good idea is to have a lot of
ideas.5
There are many variations,
such as BrainWriting, word
association and the technique
of the Japanese Broadcasting
Corp. NHK that involves the
use of cards or spreadsheets.
The commonality for these
methods is that they allow
people to make crazy sugges-
tions in private and perhaps
avoid ridicule, but gradually
they can share those ideas and
build on them.
To be successful with ide-
ation, we need:
++ KnowledgeDo people
know the problem?
++ DiversityWill solutions get
challenged?
++ DisruptionAre disruptors
present?
We also should include cus-
tomers and suppliers. It is like
the old think-tank technique
of mixing disciplines to create
that spark of genius.
Ideation searches the sub-
conscious, and this takes time.
An important component is
soak time: Relaxing between
sessions is essential, and often,
the epiphany will come unex-
pectedly. Thats why ideation
is not a one-off 20-minute ses-
sion done once a year. In fact,
epiphanies are the last piece to
the jigsaw puzzle and they arise
from previously working on a
problem. Archimedes famous
QP 45
Innovation Imperative
exclamation Eureka! came after working
for a long time on how to establish the
density of the gold in the kings crown.
You also must determine what aspects
of your present product or service could
be blocking the solution. Organizations
that have developed successful innova-
tions had the courage to remove sacred
attributes of their existing products.
As noted earlier, Pauling said the best
way to have a good idea is to have lots of
ideas. One is not enough. At this stage, you
must find alternative solutions. You will stay
with the concept and evaluate the concept.
Call it prototyping if you like, but at a very
conceptual level. You are not yet develop-
ing a working process, product or service.
Selecting the solution
Having generated volume, we now must
identify solutions most likely to fulfill
customer needs and, at the same time, be
most difficult for competitors to copy. Still
working as a group, we use old-fashioned
storyboards (which still work for group
critique) and sticky notes. We must collect
data to support our choices, however.
W. Edwards Deming said, In God we
trust, all others (must) bring data.6 This is
not easy to follow for some creative people,
so include developers who are data people.
Some of the areas in which we need data
(and most wont be crisp) include:
++ The time needed to develop a working
solution. At this stage, we are only at
concept.
++ The probability of being able to produce
a working solution.
++ The cost of producing a working
solution.
++ Do we have the in-house competencies
to produce the solution?
++ Which new suppliers are needed, and
what is the risk attached to those
suppliers?
++ What are the delivery chain choices and
the attendant risk?
It is critical that the attached risk is
measured and managed.
There is a key lesson here for the
46 QP May 2017 qualityprogress.com
innovator: People can copy your offering and even steal your technology, but it is much
more difficult for them to steal your unique competencies. Always choose solutions in
your area of greatest competency.
Test your ideas
After you have short-listed your solutions, you will follow with testing, information gath-
ering and changes in direction (pivoting) as the solution is revised to arrive at the final,
validated version. Typically, the conceptual solution changes radically as testing unfolds.
Fail early. Clearly, the more you can weed out weak offerings in the creative phase, the
better the cost outcome. You find what works, stop the things that dont and resource
the things that do.
The future of problem solving
We are increasingly seeing virtual ideation software as workgroups operate remotely.
Artificial intelligence (AI) has developed rapidly since 2000 as computing power has
increased.
AI will accelerate problem solving. Humans, however, are still far more capable of fast,
intuitive judgement because of one remarkable attribute: common sense. And this unique
trait is based on the enormous body of knowledge and experience a person carries.
The World Economic Forums report on the Future of Jobs shows some interesting
trends from 2015-2020 in skills needed.7 Creativity is in 10th place in 2015 and third in
2020. Complex problem solving remains at No. 1 on both charts. This is what employers
will want in their employees. Both of these skills are attributes of an innovator.
Sow the seeds
Connectors are those who find conceptual solutions and must include developers who
can build a working solution. Using collective knowledge is the most powerful way of
finding alternative solutions and is built on previous experiences.
Somebody will be sure to say, You cant do that, so be prepared to sacrifice sacred
aspects of your current process or product. Ideation, even though it is loose, follows a
definite process, and an epiphany is really the last piece to the jigsaw puzzle.
Sow the seeds of creative problem solving at a level where you know you can suc-
ceed.
REFERENCES
1. Albert Einstein, BrainyQuote, www.brainyquote.com/quotes/quotes/a/alberteins130982.html.
2. Albert Einstein, AZ Quotes, www.azquotes.com/quote/811850.
3. Peter Merrill, Innovation Never Stops, ASQ Quality Press, 2015.
4. Edward de Bono, Lateral Thinking: Creativity Step by Step, Harper Colophon, 2015.
5. Linus Pauling, BrainyQuote, www.brainyquote.com/quotes/quotes/l/linuspauli163645.html.
6. W. Edwards Deming Institute Blog, Large List of Quotes by W. Edwards Deming, https://blog.
deming.org/w-edwards-deming-quotes/large-list-of-quotes-by-w-edwards-deming.
7. World Economic Forum, The Future of Jobs: Employment, Skills and Workforce Strategy for the
Fourth Industrial Revolution, January 2016, www3.weforum.org/docs/WEF_Future_of_Jobs.pdf.
Peter Merrill is president of Quest Management Inc., an innovation
consultancy based in Burlington, Ontario. Merrill is the author of
several ASQ Quality Press books, including Innovation Never Stops
(2015), Do It Right the Second Time, second edition (2009), and
Innovation Generation (2008). He is a member of ASQ, previous
chair of the ASQ Innovation Division and current chair of the ASQ
Innovation Think Tank.
 Advice to advance your career

GOAL SET TING

Are You
Experienced?
Modified Ishikawa diagram provides career
self-assessment tool, helps achieve goals

by Lance B. Coleman Sr.

One of the best pieces of advice Ive received during my realistic assessment of your
career was: Look above, behind and beside you as you travel abilities and credentials. This
along your career path. In other words, cultivate relationships is an important distinction to
with those who have traveled the path that youre aspiring to make because you may not
experience. Seek their counsel when needed, use their success as always be allowed to attempt
an inspiration, and take advantage of positive peer pressure. everything you are capable
Its important to have people in your professional life who are of doing. If your credentials
at or near the same point in their careers as you, and are striving dont tell your current or
to move forward. These relationships can provide support, inspi- potential employer that there
ration, counsel and a positive competitiveness. is minimal risk in assigning you
You also should try to help people who are following your the job or project, you wont
path. Mentoring benefits mentors as well as those being men- get the opportunity. So, the
tored. Mentoring, teaching or otherwise sharing knowledge helps keys to success are to deepen
develop a more profound understanding of your own expertise. and broaden your levels of
Sharing lessons learned from your experiences prompts valuable expertise, and ensure your
reflection on your past triumphs, lessons learned and profes- credentials reflect your ability.
sional growth. Additionally, helping people is just a good thing to Networking is still incredi-
do. Make known your willingness and ability to assist, and provide bly important, though. Being
assistance when asked. You can offer help, but dont force it on recognized individually or
anyone even if they seem to truly need your help. as part of a respected and
recognized organization can
What and who you know give job candidates a leg up
A popular piece of wisdom shared in the professional world is: on their competition. Without
Its not what you know. Its who you know. Not trueits both an accurate assessment of
who and what you know that counts. In an increasingly com- the gap between your current
petitive global market, instances of obvious nepotism are not as abilities and the position you
prevalent as in the past. Having the right skills and credentials are desire, you wont know which
the most important factors in securing the job of your dreams. resources you need or how
The first step in moving your career forward is conducting a your contacts could assist you.
Generally speaking
Here are some general tips Ive
practiced and benefited from
during my career:
1. Master your job function:
Become excellent at it. This
builds good habits and is the
first step in getting noticed
positively by management.
2. Become the best at some
aspect of your job: to the
point that people come to
you for help or training;
management will take
notice.
3. Acquire knowledge and
learn a skill pertaining
to the position that you
desire.
4. Learn to do something
outside of your job func-
tion that will make your
managers life easier: Even
being helpful in a small way
when you dont have to will
be remembered and can
provide great returns.
5. At each stage of your
career, look for help: This

qualityprogress.com May 2017 QP 47

 could include mentors and upwardly mobile peers FIGURE1

Inverse Ishikawa diagram

along with those aggressively progressing the
career ladder behind you.
6. Avoid the naysayers and complainers: Typically,
no good will come of these conversations. Organization Injection Met/Insp/QT
Regulatory 2.0
7. Embrace continuous improvement: Continually industry 2.0 molding 1.0 3.0
strive to expand your knowledge and skill set. Dont Resource(s) Resource(s) Resource(s) Resource(s)
be afraid to look to unconventional sources for
learning opportunities.
Action(s) Action(s) Action(s) Action(s)
Practical application
My tips sound nice in theory, but you must know how Resource(s) Resource(s) Resource(s) Resource(s)
Promotion
to successfully put them into practice. Ill use a real- to quality
Action(s) Action(s) Action(s) Action(s) engineer
life example to explain how to do this.
Start by using the tools of your profession to help
advance your career. Figure 1 illustrates what I call an Resource(s) Resource(s) Resource(s) Resource(s)
inverse Ishikawa diagram (IID). Instead of identifying
possible root causes of an adverse event, the IIDs
head represents a desired event, and the bones are Action(s) Action(s) Action(s) Action(s)
inputs needed to drive toward the desired future
state. The name is an intentional misnomer because Resource(s) Resource(s) Resource(s) Resource(s)
the Ishikawa diagram was always meant to be both a
Action(s) Action(s) Action(s) Action(s)
planning and root cause analysis aid; its just predom-
inantly used to determine root causes. Lean and Technical
RCA/CAPA 4.0 Auditing 4.0
Six Sigma 1.0 writing 4.0
To learn about actions and resources needed to
advance your career, read the online sidebar article,
CAPA = correction and preventive action Met = metrologist
Determining Career Action and Resource Needs, on RCA = root cause analysis Insp = inspector
this columns webpage at www.qualityprogress.com. QT = quality technician

48 QP May 2017 qualityprogress.com

Case study:
Career reset
The case study in Figure 1 was
a situation in which a quality
professional was hired for a job
as a quality control inspector
after spending years away from
the industry and his or her last
job was a quality manager. The
person had to restart his or her
quality career from scratch. The
initial goals set were to become
a quality engineer within 18
months and double his or her
starting salary in 36.
A critical assessment was
conducted to identify how the
person rated in each category.
A table was created that listed
key quality engineer attributes,
and it included a column for
rating the persons ability and
another column to document
his or her credentials (see Table
1). The key quality engineer
attributes were determined
by reviewing the employers
job description for the quality
engineer as well as the body of
knowledge for ASQs quality
engineer certification.
The key attributes along with
the associated assessment
ratings were used to label
the bones of the IID. For each
branch, actions were identi-
fied that needed to be taken
and the resources needed or
available to improve the self-
assessment rating in that area.
The goal was to have a self-
assessment rating of three or
higher in each category. Table
1 shows a listing of eight iden-
tified critical quality engineer
attributes, plus the columns for
the self-assessment ratings and
credentials.
You can use the self-assess-
ment for any position. Start by
rating yourself in each of the
critical attributes of the position
you hope to attain on a scale of
one to five based on these five TA B L E 1
definitions:
OneNovice.
TwoSome experience,
Quality engineer self-assessment
confident in the basics. Ranking
ThreeExperienced and Quality engineer attributes
Expertise Credentials
competent, might provide
1. Auditing knowledge 4.0 CQA
novices on-the-job training.
FourHighly skilled, could Root cause analysis and corrective
2. 4.0
action knowledge
train others in a formal setting.
FiveExpert, could serve as 3. Standards and regulations knowledge 2.0
external consultant or expert 4. Industry/organization knowledge 2.0
trainer. 5. Lean and Six Sigma knowledge 1.0 AAS-EET
The next step is to plug into 6. Technical expertise (injection molding) 1.0
your IID, and use the plan-do-
7. Technical writing/communications 4.0 AAS-EET
check-act cycle to go through
an iterative process. 8. Metrology/inspection/quality tools 3.0
Project goals: Promotion to quality engineer within 18 months and
salary doubled within 36 months.
Plan: Project results: Promoted to quality engineer within 14 months and
++ Determine the IID categories. salary doubled within 30 months.
++ Populate the IID with
CQA = certified quality auditor
actions and resources. AAS-EET = associate of applied scienceselectronics engineering
++ Identify any failure risks that technology
must be addressed.
Do: Charting your path
++ Put in place any needed risk A combination of experience, training and education is needed
mitigations. for a successful quality professional to gain expertise. Creden-
++ Implement the plan. tials are what lend credence to that expertise in the professional
world. Take into account the advice and experiences of others,
Check: but only as inputs to your own decision making.
++ Reassess your skills every Always chart your own path, and find a good work-life
six months. balance. Understand that at some point in your life, one may
++ Check and plan milestones. take precedence over the other due to shifting priorities. Life
is ever-changing and you must remain flexible. The key is that
Act (based on check- your work-life schedule must return to a balanced state, and it
phase results): shouldnt take years to do so.
++ Revise the plan if its not Knowledge can come from many sourcessuch as formal edu-
working appropriately. cation, classroom training, on-the-job training, knowledge from
++ If the plan is working as networking and mentoring, volunteer experience or industry
planned, continue forward. research. Expanding and applying that knowledge is crucial to
++ If the plan is complete and successful career advancement. I will conclude with the following
successful, identify new wish for all of you: May the boundaries of your potential never be
goals. framed by the limits of your knowledge.
Lance B. Coleman Sr. is quality audit program manager at Ultradent
Products Inc., South Jordan, UT. He earned an associate degree in electrical
engineering technology from Southern Polytechnical University in Marietta,
GA. A senior member of ASQ, Coleman holds the following ASQ certifications:
quality auditor, biomedical auditor, quality engineer and Six Sigma Green
Belt, along with the Exemplar Global quality management systems principle
auditor certification. He is the author of Advanced Quality Auditing: An
Auditors Review of Risk Management, Lean Improvement and Data Analysis
(ASQ Quality Press, 2015).
qualityprogress.com May 2017 QP 49
Solving quality quandaries through statistics

Statistics Spotlight
1213231315447133415341545721157945495241262
124345464755497541275299949514654237204317
91545154134541213231315447133415341545721157945495241262
124345464755497541275299949514654237204317
91545154134541213231315447133415341545721157945495241262
124345464755497541275299949514654237204317
91545154134541213231315447133415341545721157945495241262
124345464755497541275299949514654237204317
91545154134541213231315447133415341545721157945495241262
124345464755497541275299949514654237204317
91545154134541213231315447133415341545721157945495241262
124345464755497541275299949514654237204317
9154515413454

LEAN SIX SIGMA

Time for Lean

Six Sigma 2.0?
Quality improvement must adopt a new paradigm to
respond to todays challenges
by Ron Snee and Roger Hoerl

One of the primary roles of statisticians and quality professionals

is to help their organizations solve problems and improve their
performance. Lean Six Sigma has proven over decades to be an
effective approach to improvement. The question is whether a
better approach to achieve even higher levels of improvement
is needed. Does lean Six Sigma warrant a version 2.0?

Huge impact of lean Six Sigma

The history of Six Sigma goes back to Motorola in 1987.1
Facing stiff foreign competition in the pager market,
Motorola desperately needed to improve quality and
lower costs to stay in business. Through Six Sigma, it
could do both. Other electronics manufacturing compa-
nies, such as Honeywell and AlliedSignal, saw Motorolas
success and soon launched their own initiatives.
In 1995, General Electric (GE) CEO Jack Welch
announced that Six Sigma would be the biggest initiative in
GEs history, and would be his personal No. 1 priority for the
next five years.2 GE reported billions of dollars of savings over
the next several years, resulting in a much larger pool of organi-
zations adopting Six Sigma, not to mention significant growth in
GE stock price.
Honeywell, GE and others realized that a different approach was
needed when designing new products and services. When designing
a new process, there is nothing to improve because the process doesnt
exist yet. Based on earlier design work by Honeywell, GE developed the

50 QP May 2017 qualityprogress.com

define, measure, analyze, design and verify
(DMADV) approach to design for Six Sigma
(DFSS).3
Several major health networks launched
Six Sigma initiatives, including Common-
wealth Health Corp., which reported $1.6
million in savings in its radiology depart-
ment alone in the first year.4 Among other
innovations to Six Sigma, GE developed an
approach to applying Six Sigma outside
of manufacturing, including to financial
processes at GE Capital. Bank of America
became the first major bank to launch a Six
Sigma initiative in 2001.5
As early as 2003, practitioners were
noticing Six Sigmas limitations. Toyota had
developed generally accepted principles
of manufacturing excellence over several
decades of intense improvement efforts on
the assembly line. These principles, often
referred to as lean manufacturing, were often
overlooked in Six Sigma projects because
they were simply not well known. Michael L.
George suggested integrating lean princi-
ples with Six Sigma to create the broader
improvement initiative lean Six Sigma.6 GE
and others quickly transitioned their Six
Sigma initiatives to lean Six Sigma. Results
continued to roll in.
Dramatic change since 1987
While lean Six Sigma has been a tremendous
success, the world has changed considerably
since 1987. Table 1 lists a few of these
macro-societal shifts.
Obviously, there have been massive shifts
in the global economy since 1987. While
Motorola was already facing stiff global
competition, globalization has accelerated
even more dramatically since then. India has
become globally recognized for its IT prow-
ess, China has become a dominant player
in manufacturing, and large numbers of call
centers supporting global customers have
sprung up in developing countries such as
the Philippines.
The world also has recognized the need to
collectively address large, com-
plex and unstructured problems. A different paradigmholistic
The issue of global climate change improvementis needed to
cannot be addressed by any one take continuous improvement
organization or even one country. to a new level in todays world.
It is simply too big of an issue.
Security has always been a con-
cern to societies and to businesses. Prior to the Sept.
11, 2001 terrorist attacks, many in the United States
and some western European counties believed that
terrorism was something that occurred elsewhere, not
in their counties.
Beyond terrorism, individuals and businesses have
serious security concerns over computer hacking.
Protecting against identity theft has become a
billion-dollar industry in the United States alone.
It is clear that we live in a different worldsome
would say a much more dangerous worldthan
in 1987. How should you think about continuous
improvement in such a world? Is lean Six Sigma the
best approach to take for all problems, including
large, complex and unstructured problems, such as
climate change?
TA B L E 1
Macro-societal shifts since 1987
++ Accelerated globalization.
++ Massive immigration into North America and Europe.
++ Growth of IT and big data analytics.
++ Recognition of uniqueness of large, complex unstructured problems.
++ Modern security concerns (for example, terrorism and computer hacking).
TA B L E 2
Versions of Six Sigma to date
++ 1.0: Original roll-out at Motorola1987.
++ 1.1: General Electric enhancementscirca 2000.
++ 1.2: Lean Six Sigmacirca 2005.
++ 1.3: Lean Six Sigma and innovation (ambidextrous organizations)circa 2010.
qualityprogress.com May 2017 QP 51
Statistics Spotlight 1213231315447133415341545721157945495241262
124345464755497541275299949514654237204317
91545154134541213231315447133415341545721157945495241262
124345464755497541275299949514654237204317
91545154134541213231315447133415341545721157945495241262
124345464755497541275299949514654237204317
91545154134541213231315447133415341545721157945495241262
A different paradigmholistic improvementis
needed to take continuous improvement to a new
level in todays world.7,8 The best method to deploy
it would be a new version of Six Sigma called lean
Six Sigma 2.0.
The evolution of lean Six Sigma
What does lean Six Sigma 2.0 mean exactly? Over
the lifetime of Six Sigma there has been consider-
able evolution. These enhancements (see Table 2,
p. 51) have been primarily incremental and have not
rethought the fundamental paradigm of Six Sigma.
The development of Six Sigma at Motorola is
referred to as Six Sigma 1.0. This method focused on
manufacturing and improving existing processes.
GE made several enhancements to Six Sigma, such
as adding the define stage, developing the DMADV
approach to design projects and broadening the
effort beyond manufacturing to commercial qual-
ity,9 including finance, healthcare and administrative
processes, producing version 1.1.
The first major effort at integration of lean and
Six Sigma occurred when lean manufacturing
principles were integrated with Six Sigma, creating
lean Six Sigma,10 which we call version 1.2. A major
advantage of lean Six Sigma is that it minimized
competition between lean and Six Sigma practi-
tioners, and put both sets of proponents on the
same team. It also broadened the scope of prob-
lems that could be tackled effectively.
More recently, researchers and practitioners
have investigated the relationship between lean Six
TA B L E 3
Limitations of
lean Six Sigma 1.3
++ Still not appropriate for all problems.
++ Simple problems.
++ Large, complex unstructured problems.
++ Does not incorporate routine problem solving.
++ Not a complete quality management system.
++ Does not take advantage of big data analytics.
++ Does not address modern risk management issues.
52 QP May 2017 qualityprogress.com
Sigma and innovation. Brian Hindo evaluated issues in Six Sigma
deployment at 3M and suggested that Six Sigma and innovation
were antagonistic.11 Hindo contended that deploying Six Sigma,
while making important incremental improvements, would dam-
age a creative and innovative culture, such as that at 3M, because it
was too rigorous and disciplined.
Roger Hoerl and Martha Gardner demonstrated that lean Six
Sigma could actually enhance the innovation of an organiza-
tion, producing version 1.3.12 They pointed out that the scientific
method, upon which lean Six Sigma is based, has sparked cre-
ativity and accelerated innovation for centuries.
For long-term success, organizations must be able to be
operationally efficient, continuously improve existing operations
and innovate to develop new products and services, wrote Julian
Birkinshaw and Cristina Gibson.13 They refer to organizations that
can optimize operations (exploitation) and innovate (explo-
ration) as ambidextrous. Six Sigma does help organizations
achieve ambidexterity by helping them continuously improve
existing operations and enhance, rather than stifle, creativity and
innovation.14-16
Lean Six Sigma 1.3 limitations
There is much to commend about lean Six Sigma 1.3. It covers a
diverse array of application areas, from internet commerce and
other high-tech industries to healthcare, finance and, of course,
manufacturing. It has incorporated key lean principles from the
Toyota Production System.
Research has documented a clearer, synergistic relationship
between lean Six Sigma and disruptive innovation, and demon-
strates how to use DFSS projects to take innovative concepts
to market. Despite these advantages, there are still important
limitations (see Table 3).
Lean Six Sigma 1.3 is not the most appropriate approach for all
projects. For example, Hoerl was asked years ago to help a GE
computer scientist with his Six Sigma project. When Hoerl asked
him about the project, he stated that it involved the installation of
an Oracle database. Hoerl asked if he knew how to install an Ora-
cle database, and he replied, Yes. Hoerl asked if he had done
this before successfully, and he again replied, Yes. Hoerl, now
with a puzzled look on his face, asked what the problem was that
required solution. The computer scientist replied that there was
no problem to be solved, but that his boss had told him to use Six
Sigma on this installation, so this is what he was going to do.
This is a classic case of a solution-known problem.17 That is,
you have a problem, but the solution is already known. This does
not necessarily mean that the solution is easy to implement
installing databases is not trivial. However, there is no need to
analyze data to search for a solution. Rather, you just need to
ensure that the people doing the work have the right skills, expe-
rience and procedures to properly implement the known solution.
The question of whether
the solution is known or Thomas Kuhn noted that the
unknown is a key con- need for a new paradigm
sideration in choosing a is recognized when the list
method. of problems not solved by
The important point is existing paradigms becomes
that Six Sigma was not too large to ignore.
needed, and perhaps
not even helpful, for this
installation. Some type of formal project management system
and possibly database protocols were needed to ensure success.
The integration of lean into Six Sigma helps avoid force-
fitting Six Sigma because lean may be an appropriate method
for a given problem when Six Sigma is not. For example, lean
has proven principles that provide excellent guidance on
solution-known problems.18 However, just as Six Sigma is not
appropriate for all problems, neither is lean.
Any time you select the problem-solving method before you
have clearly documented the problem, you are prone to force
fitting. Shouldnt you learn about the problem first, and only then
determine the best approach to finding a solution? Who would
continue to see a physician who recommends treatment prior to
learning about the patients condition?
Similarly, lean Six Sigma 1.3 does not incorporate routine prob-
lem solving. That is, suppose a manufacturing line begins leaking
oil at 3:30 a.m. This is not the time to put together a Six Sigma
team to gather data and study the problem for a few months;
someone needs to stop the leak ASAP. By routine problem solv-
ing we mean the day-to-day problem solving that occurs in all
organizations, typically in real time.
Some problems are not easily solved on a routine basis.
For example, suppose this is the fifth time this year one of the
machines in the plant has begun leaking oil. Why is this problem
recurring? Is the fundamental root cause the oil itself, the equip-
ment, the way we are operating the equipment, the way we are
maintaining the equipment, or something else?
To solve this higher-level problem, a team and some formal
method, perhaps Six Sigma, will likely be needed. The point is
that routine problem solving is an important aspect of contin-
uous improvement; however, you typically do not need lean
Ronald D. Snee is president of Snee
Associates LLC in Newark, DE. He has a
doctorate in applied and mathematical
statistics from Rutgers University in
New Brunswick, NJ. Snee has received
ASQs Shewhart, Grant and Distinguished
Service Medals. He is an ASQ fellow and an
academician in the International Academy
for Quality.
Six Sigmanor is there timeto conduct a lengthy
project. Immediate solutions are needed.
Fundamentally, lean Six Sigma 1.3 is a project-based
method for driving improvement, but it is not a com-
plete quality management system (QMS). That is, it
does not replace ISO 9000 quality systems or provide
the same breadth as national quality awards, such as
the Baldrige award. For example, individual Six Sigma
projects may lead to calibrating measurement equip-
ment in a lab in the measure phase, but they would
not provide an overall lab calibration system.
In our view, minor adjustments to lean Six Sigma
1.3 will not address these limitations. Rather, a new
paradigm will be needed. Thomas Kuhn noted that
the need for a new paradigm is recognized when the
list of problems not solved by existing paradigms
becomes too large to ignore.19 For the reasons noted
earlier, we feel lean Six Sigma 1.3 is now at this place.
Time to make the leap?
Some time has passed since Six Sigma was intro-
duced and lean Six Sigma was developed. In the
meantime, the world and its needs have changed.
As a result, quality improvement must adopt a new
paradigmone of holistic improvement called lean
Six Sigma 2.0.
This approach must incorporate various improve-
ment methods for different types of problems,
integrate with an overall QMS, and address the other
limitations of lean Six Sigma 1.3 noted in Table 3.
Next months Statistics Spotlight will elaborate
on what such a system might look like, including
consideration of large, complex and unstructured
problems, the emergence of big data analytics, and
the increased importance of risk management in
todays world.
2017 Ronald D. Snee and Roger W. Hoerl
EDITORS NOTE
The references listed in this article can be found on the Statistics
Spotlights webpage at www.qualityprogress.com.
Roger W. Hoerl is a Brate-Peschel assistant
professor of statistics at Union College
in Schenectady, NY. He has a doctorate
in applied statistics from the University
of Delaware in Newark. Hoerl is an ASQ
fellow, a recipient of ASQs Shewhart
Medal and Brumbaugh Award, and an
academician in the International Academy
for Quality.
qualityprogress.com May 2017 QP 53
 Standards-related developments and activities

Standard Issues
INTEGRATED MANAGEMENT SYSTEMS

All Together Now

Integrate management systems during your ISO 9001:2015 transition

by Govind Ramu

Even though my organization focused on integrating quality Another example might
management systems (QMS, ISO 9001), environmental man- be when a new blend of
agement systems (EMS, ISO 14001) and occupational health a chemical ingredient in a
and safety management systems (OHSAS 18001), other orga- new technology can help to
nizations also could integrate relevant management systems significantly improve product
to their business, including energy management system (ISO performance, but at the same
50001), food safety management system (ISO 22000) and time, be harmful to the environ-
information security management system (ISO 27001).1 ment if not carefully discarded
There are several benefits to having an integrated manage- or hazardous to users if they
ment system (IMS). In the long term, an IMS helps improve are not properly trained. An
efficiency by removing redundancies of different management organization that just looks to
systems. Thanks to the high-level structure established for improve product performance
management systems standards, 2 it is now possible for key may not consider the perspec-
requirements and processes to be integrated without having to tives of other management
add a cross-reference matrix of documented information. systems.
Several requirements and processes in an organization can This is why its important
benefit from integration, as shown in Table 1 (p. 56). Any orga- that all relevant information be
nization aspiring to set up an IMS should consider a phased monitored and reviewed, and
implementation approach. As the organizational management positive and negative factors
system matures and addresses challenges, the organization can or conditions considered. In
gradually integrate other requirements and processes. Forcing an a larger organization, this is
integration all at once isnt a good idea because your organiza- performed during the strategic
tion simply may not be ready. planning process. In small and
medium-sized organizations,
Context of the organization this can be done during a peri-
Defining the context of the organization involves determining odic integrated management
external and internal issues relevant to its purpose, strategic review meeting.
direction and ability to achieve the intended results3 of the IMS. During this review, an
An organizations strategic direction might involve the organization identifies new
introduction of new products. Technology, for example, can interested parties and evalu-
help with innovation. At the same time, it can be disrup- ates the relevance of current
tive and require consideration of external issues, such as interested parties and their
compatibility with other products in the market, market needs and expectations. An
acceptance, safety concerns and the impact on the environ- organization with an IMS takes
ment and local community. advantage of such a meeting
to explore issues, needs and
expectations of interested par-
ties without having to replicate
the efforts for each manage-
ment system separately.
Addressing risks
and opportunities
Risk assessments are per-
formed by organizations
formally and informally to
determine risks and oppor-
tunities. An organization may
formally call for a meeting with
a cross-functional team and
invite other interested parties
(such as the supplier or cus-
tomer) to identify issues that
affect the organization.
There also are times when
organizational members come
together periodically to discuss
issues relevant to their business
process or deliverable and
to identify issues that affect
their ability to meet needs and
expectations. These meetings
tend to be smaller and less
formal. Examples include a
weekly yield review, supplier
performance review and safety
committee meetings.
The cross-functional
approach tends to have
broader participation and

54 QP May 2017 qualityprogress.com

provide more structure for
uncovering issues. The issues
captured in the weekly meetings
are still relevant, though, and these
meetings offer a sense of immediacy for
addressing issues.
The formal approach requires man-
agement commitment and a willingness by
the participants to share their inputs ahead of
designing and developing a product and service. In
an informal approach to capturing and anticipating
issues through the periodic meeting, the main objective
is to achieve a certain yield, ensure a certain level of sup-
plier performance or prevent injury to employees.
Action items from these meetings address risks and
opportunities. Although you may not necessarily call the
outcomes from these meetings risks and opportunities,
and there likely isnt severity, probability of occurrence or
prioritization assigned to them, all risks and opportunities
are equally weighted and all are addressed.
Irrespective of how structured or sophisticated the risk
assessment, the actions are required to be integrated
with the management systems, and their effectiveness
should be evaluated. Examples of these action items
include implementing new controls, updating docu-
mented information and providing additional training.
An organization with an IMS brings representation
from all management systems to the formal review
and applicable informal reviews (such as weekly
meetings) to capture risks and opportunities from all
perspectives.
Documented information
While there is no requirement for a quality, environ-
mental, and occupational health and safety manual,
organizations that find value in these materials can
continue to keep them after their transition to ISO
9001:2015 and ISO 14001:2015.
IMS organizations combine the requirements from
various management systems into one manual to
prevent redundancy.
Unfortunately, I have seen
organizations simply copy
and paste individual manage-
ment systems' content into one
document thinking that makes it
integrated. In reality, it is only com-
bined contentnot integrated.
To provide the most benefit, an IMS
manual should truly be integrated. Most
organizations start with sections that are
common to all management systems. Busi-
ness processes for managing documentation,
measurement and test equipment, internal
audits, nonconformities and corrective actions
are obvious areas to integrate first. As the orga-
nization understands the benefits of integration,
more business processes can be gradually
integrated.
An organization typically applies its QMS
for a process like an incoming quality inspec-
tion, for example. The need for doing this is
obvious because the specification requires
incoming material to meet dimensional, metal-
lurgical and visual criteria.
There are environmental and safety aspects
relevant to this process, though, too. The
incoming quality inspection could use envi-
ronmentally unsafe chemicals for cleaning the
materials prior to inspection, discard packag-
ing materials that can create environmental
impacts, or transport and handle incoming
material from warehouse to inspection in a way
that creates safety hazards.
An IMS for a process such as this covers
requirements from all applicable management
systems and ensures the control is effective
and efficient. This prevents waste caused by
having multiple forms of documented informa-
tion for the same process.
qualityprogress.com May 2017 QP 55
Standard Issues

TA B L E 1

Recommended integrations for management systems

Section Section title Nature of integration (early stages) Nature of integration (as maturity evolves)
ref #
4.1 Context of the organization Common register (and tool) for capturing all Single forum to solicit and capture internal
management systems' internal and external and external issues, risks and opportunities
Actions to address risks issues, risks and opportunity. Capture may that affect management systems (for example,
6.1 and opportunities happen in multiple forums. enterprise risk management).
Level one manual (where organization chooses
tokeep it). Every applicable business process that can
7.5 Documented information Common process for documentation, beintegrated.
measurement and test equipment, internal audit,
nonconformity and corrective actions.
Common requirements:
documentation information, management Internal auditors competent on all applicable
system tool, items common to management management systems conducting an integrated
9.2 Internal audit systems. management systems audit (use domain experts
Management system specific requirements: where required).
concurrent audits of management systems.
Integrated management reviewcommon
Integrated management reviewall issues that affect all management systems such
9.3 Management review management systems present in the same forum. as resources, audit results, corrective actions,
opportunities and results that are integrated.
Nonconformity and Integrated actions that address applicable
10.2 corrective action Documentation information, management management systems.
system tool, actions on common items between Consideration of all applicable management
10.3 Continual improvement management systems. systems while developing and implementing a
plan, and evaluating effectiveness.

Internal audit audit managers to bombard business process owners with

Organizations often conduct separate internal audits for
their QMS, EMS and occupational health and safety man-
agement system. QMS audits require an understanding of
the business and manufacturing processes. EMS and occu-
pational health and safety system audits require knowledge
of environmental aspects and significant impact, health
and safety risks, applicable regulatory, statutory and legal
requirements. It is rare to find internal auditors with skill
sets in all of these areas.
IMS organizations tackle this challenge in a way similar
to that of documentation integration. Internal auditors can
develop a process approach and cover the items that are
common to management systems. When specific knowl-
edge in an area is required, an expert can join the team.
Internal auditing is an important control, so its important
not to dilute the process. Integration shouldnt be forced by
assigning auditors who lack skills and knowledge to any of
the management systems.
In the early stages, even without an integrated audit,
efficiency can be realized by conducting management sys-
tems audit concurrently for a given process. This will reduce
the need for QMS, EMS and occupational health and safety
requests for audits at three different times.
Management review
Having a common management review for all the man-
agement systems is one of the first things an organization
should do to integrate its management systems. This saves
significant time for top management and provides an
overall picture.
Early in the integration, it is acceptable to have QMS,
EMS and occupational health and safety representatives
present their results separately in the same meeting. This,
however, is more like a consolidated or combined man-
agement review rather than an integrated management
review.
As the organizational integration matures, results from
IMS requirements can be presented as integrated outputs.
These would include common issues, such as resources,
audit results and corrective actions, which affect all
management systems. Actions and opportunities identi-
fied also should take all of the management systems into
consideration during the development of the plans and the
verification of effectiveness.

56 QP May 2017 qualityprogress.com

Dealing with opportunities software tools, training and
Documented information for processes In an IMS, when a nonconformance meetings.
related to nonconformance, corrective is identified in one of the manage- External certification bod-
action and continual improvement can be ment system implementations, ies recognize the benefits of
readily integrated during the early stages its likely the corrective action is an IMS and offer a reduction
of the integration process. applicable to all management in audit days for conducting
In an IMS, when a nonconformance system implementations. integrated audits.4
is identified in one of the management For an organization that
system implementations, its likely the has multiple sites with IMSs,
corrective action is applicable to all management system this can be a significant cost savings that can be used to
implementations. The lack of a control in one management solicit top management support. IMS audits also reduce any
system could be a systemic issue affecting all management frequent disruption of day-to-day business activities, keep
systems. the audit communication focused and improve employee
Likewise, integrated continual improvement processes awareness.
take all management system perspectives into account. Above all, an organization can benefit from having the
Improvement actions driven by the QMS are evaluated by ability to understand how all of its business process own-
asking, Are there any unintended undesirable effects on ers actions affect all management systems, opening minds
the environment and employee safety? In other words, is to think more broadly about the life cycle of products and
higher product quality coming at the cost of the environ- services.
ment or safety?
REFERENCES
Managing these processes using a tool, such as a soft-
1. Govind Ramu, Ready, Set, Transition, Quality Progress, December
ware application, can help further enhance efficiency in 2016.
maintenance of the software tool and employee training. 2. Stefan Tangen and Anne-Marie Warris, Management Makeover
New Format for Future ISO Management System Standards,
International Organization for Standardization, July 18, 2012, http://
Challenges and benefits of integration bit.ly/2n97em5.
In the initial stages of implementation, there are sit- 3. International Organization for Standardization, ISO 9001:2015
Quality management systemsRequirements.
uations in which managers responsible for individual
4. International Accreditation Forum, IAF Mandatory Document
management systems may have conflicts as they ascer- for the Application of ISO/IEC 17021 for Audits of Integrated
tain their positions and authority. They may not agree Management Systems, Dec. 16, 2013, http://bit.ly/2mosB4I (case
sensitive).
on integrating or standardizing some of the processes.
These challenges can be resolved by alleviating any con- BIBLIOGRAPHY
cerns that a managers individual authority and positions Hortensius, Dick, Integrated Management Systems, International
Organization for Standardization, Feb. 18, 2013, http://bit.ly/2nhlQiu
will be eliminated.
(case sensitive).
Each management system requires unique skills that are Kymal, Chad, Gregory Guska and R. Dan Reid, Integrated Management
not easily replicated by people managing other man- Systems, ASQ Quality Press, 2015.
agement systems. Its important for
organizations to recognize and accommo-
date this in the planning of activities such
as internal auditing.
Another challenge is that external audi- Govind Ramuis senior director, global quality
tors with multiple management system management systems, at SunPower Corp. in San Jose,
CA, and the chair of the U.S. Technical Advisory Group to
qualifications are so few that they may International Organization for Standardization Technical
not be available to conduct an audit at a Committee 176, subcommittee 1, on ISO 9000:2015
time suitable for your organization. standards. Ramu is an ASQ fellow and holds six ASQ
certifications: manager of quality/organizational
One of the biggest benefits of IMS excellence, quality engineer, Six Sigma Black Belt,
implementation is waste reduction auditor, software quality engineer and reliability engineer. Ramu is the author
achieved by eliminating redundant doc- ofThe Certified Six Sigma Yellow Belt Handbook (ASQ Quality Press, 2016),
co-author ofThe Certified Six Sigma Green Belt Handbook, second edition (ASQ
umentation, processes, actions (which Quality Press, 2015) and a contributing author ofThe Lean Handbook(ASQ
could sometimes be contradictory), Quality Press, 2012). He is also the recipient of the 2017 Crosby Medal.

qualityprogress.com May 2017 QP 57

 Newly released products and tools

Marketplace OUTLETS

Light the Way

Schurters 6600-5 series IEC outlets are available with
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distributed power applications.
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MEASURE
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The 6600-5 series offers a pull-out safety device to prevent against unintentional
Indicators
Mitutoyo America Corp. has
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58 QP May 2017 qualityprogress.com

CAMERA

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qualityprogress.com May 2017 QP 59

 The Certified Six Sigma Yellow Belt Handbook
GOVIND RAMU ASQ QUALITY PRESS 2016 312 PP. $69 MEMBER $105 LIST (BOOK).

The audience for this book is those interested in passing the ASQ-certified Six Sigma Yellow
Belt (CSSYB) exam. Also, it serves as a handy reference for those implementing Six Sigma
projects, and can be used as a college or trade school textbook.
The book is divided into five sections aligning with the CSSYB body of knowledge (BoK).
Every chapter concludes with typical exam questions that indicate understanding and compre-
hension of the subject matter.
The beginning of the book covers Six Sigma basics, including a limited view of lean, roles,
teams, tools and metrics. The book uses the define, measure, analyze, improve and control
(DMAIC) process for parts two-five. Part two, the define phase, addresses identifying a project
and how to manage it. Part three, the measurement phase, touches on statistics, data collection
and measurement system analysis. Part four, the analysis phase, dives into a lot of tools and
analysis such as process mapping, normal and binomial distributions, as well as correlation and
regressions. Part five, the improve and control phase, is relatively short but explains kaizens,
the design of experiments, cost of quality, cost of poor quality and offers many control chart
examples. The last portion of the book houses the appendixes, covers the CSSYB BoK and any
remaining charts, formulas, distributions and acronyms.
Overall, this book is a good overview of most of these tools and improvement processes for a
Yellow Belt level. I recommend it to anyone in search of a comprehensive handbook.
---Bill Baker, Speed To Excellence, Santa Fe, NM

Additions to your quality library

Footnotes
ISO Lesson Guide 2015: Pocket Guide to items included in the guide that
ISO 9001:2015 were unnecessaryfor example,
J. P. RUSSELL ASQ QUALITY PRESS 2016 102 PP. $14 MEMBER
repeating the ISO 9001 standard
$24 LIST (FOURTH EDITION, BOOK).
requirement relationship chart
at each sections beginning, and
Like most of the ASQ pocket guides, this book provides a wealth of attaching it in a larger, fold-out
information in a conveniently-sized volume. This edition translates laminated piece to the back cover,
the latest version ISO 9001 standard into easy-to-understand which was not fully visible unless
language. It covers only those standard sections with specified you detached it. Some of the
requirements. Every key concept is highlighted. Each requirement analogies and examples were not
is abstracted with one or two interpretations to explain the mean- as direct as they could have been. The space given to these items
ing. What doesnt apply or isnt relevant is skipped. could have been more effectively used to add to the minimal cov-
The author is concise and practical, providing guidance that erage of the seven quality management principles, even though
avoids long, nonvalue added information. One example is the not strictly part of the standard or purpose of this book.
assertion that your quality policy itself is likely of little value, This is one of the better treatments of the standard. It will
but the debate and activities to develop it are of great use and be easy to take materials directly from this guide and develop
importance. Similarly, the discussion of risk includes not only the training your organization will need on the ISO 9001:2015
catastrophic issues, but also common, everyday probabilities. revisions.
Given the limited amount of space, I did think there were some ---Mark A. Feldmen, Houston

60 QP May 2017 qualityprogress.com

Achieving Customer Experience Excellence Through a Quality
Management System
ALKA JARVIS, LUIS MORALES AND ULKA RANADIVE ASQ QUALITY PRESS 2016 256 PP. $30
MEMBER $50 LIST (BOOK).

Research into quality man-
agement systems (QMS)and
achieving results from these
systemsis more than moni-
toring procedures, measuring
results and taking corrective
action. The core concepts
of this book focus on the
customers experience as
tangible items. The concepts
also address as procedures
are developed, managed,
made available and delivered.
This book starts with chapter
one defining the customer
experience, and chapter two
reviewing the life cycle of
the experience. These initial
chapters provide a resource
for advanced work, including
scholarly work, in the broad
and complex fields of quality.
The customers experience
is the point of focus as quality
is delivered through created
and manufactured items. Cus-
tomer experience is explored
and procedures documented
in a research-based approach.
As strategies are presented
and procedures are facilitated,
the customer experience must
lead to measurable and man-
ageable outcomes. Procedures
for managing, delivering and
documenting the customer
experience are explored in
relation to the ISO 9001:2015
structure.
The last portion of the book
explores the QMS, customer
experience interlock, and
strategies to optimize the
customer experience. Orga-
nization and presentation of
specifics to defining, deliver-
ing, assessing and managing
customer experience are
included in these docu-
mented chapters. Included
is a detailed index that fully and team working to deliver
supports the use of this book. and confirm delivery of cus-
Organization, documenta- tomer service. This book also
tion, use of charts and tables, is an idea generator for those
graphics and writing style creating a manual of complex
place this book as a useful operations in their organization.
reference in a customer centric Finally, it should be used by
operation. quality managers researching
I recommend this book to the customer experience.
organizations with a person ---Gerry Brong, Ellensburg, WA

The ISO 9001:2015 Implementation Handbook: Using the Process

Approach to Build a Quality Management System
MILTON P. DENTCH ASQ QUALITY PRESS 2016 168 PP. $30 MEMBER $50 LIST (BOOK AND CD-ROM).

The race is on, and the Sept. 14, 2018 deadline to transition from the ISO 9001:2008 to the ISO
9001:2015 is fast approaching. There are still currently certified ISO 9001:2008 organizations, as
well those seeking certification for the first time, that have not made the change or started planning
for the transition. This book should help such organizations by providing them with a well thought
out approach for aligning their existing practices to the ISO 9001:2015 requirements efficiently,
maintaining and improving them.
Chapter one includes the history and chronology of ISO 9000, followed by chapter two in which
the author provides a concise, yet helpful, introduction to the plan-do-check-act (PDCA) method
and applying this approach in the ISO 9001:2015-based quality management system (QMS).
Chapters three through 10 cover the main clauses of ISO 9001:2015. Each chapter includes the ISO
9001:2015 requirement along with the corresponding ISO 9001:2008 requirements, followed by an
in-depth clarification of each requirement. Finally, a list of audit questions is supplied to assess the
current level of conformance to the requirements.
Chapter 11 includes interpretation guidance that could potentially reduce the ambiguities in some
clauses of the standard and clarifies the intent of the requirements. In the same chapter, the author
provides an insight into the benefits of removing the preventive action requirements with the goal
of preventing potential nonconformance to the standard. This allows organizations to use tech-
niques that have proven to be effective in addressing the preventive action requirements.
The main advantage of reading this book is that it includes comments and insights from the
author, who has extensive experience in conducting ISO 9001-based QMS audits in many organiza-
tions in a wide variety of industries.
---Herzl Marouni, Houston

qualityprogress.com May 2017 QP 61

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 Maintaining
A refresher on a quality
tool, concept or method
Knowledge
How ISO 9001:2015 is helping
organizations remember their future
by Paul E. Boyers
Those who cannot remember the past are condemned
to repeat it, George Santayana, 1905.1
Many root cause investigations end with the corrective
and preventiveaction (CAPA) of retraining the employee.
But companies are often content to see retraining as
a repeated responseto a root cause analysis (RCA). This
repetition should raise several questions:
++ What type of training program is in place?
++ Why was the training ineffective?
++ Did the employee attend the training?
++ Did the employee actually understand the training?
++ Does the organization use a method to determine the
trainees level of comprehension and competence?
++ Does the organization practice RCA or do they investi-
gate and correct incidents?
Training requires controls
The training process is like the manufacturing process and
follows similar steps:
++ Gathering raw material (information).
++ Processing raw material into an acceptable product
(training program).
++ Transferring product to the customer (trainee).
Most manufacturing process steps are subject to controls
that are monitored and evaluated. But often, organiza-
tions allow training programs to operate without controls
or standards.
As a process, training is an essential part of the quality
management system and should be subject to the same
quality controls and standards applied to the manufactur-
ing process. Even though training is an investmentin time
and resources for most manufacturers, it's often undocu-
mented, uncontrolled and unevaluated.
Internal trainers, while frequently the subject mat-
ter experts in their area of responsibility, may have
little-to-no training skills. Their skills have been devel-
oped through trial and error while mentoring other
employees. These trainers often have insufficient guid-
ance from the organization on correctly training new
employees for positions. When these trainers move to
64 QP May 2017 qualityprogress.com
other positions,organizations often lose their technical
proficiency and any training knowledge they've gained
from mentoring other employees.
Knowledge management in ISO 9001:2015
Clause 7.1.6 of ISO 9001:2015 tries to address the potential
loss of knowledge by helping the organization remember
its own past. The standard helps organizations deter-
mine the knowledge required for its daily operations and
respects that business knowledge is organization-specific.
It acknowledges that the best knowledge to achieve the
organizations objectives is often gained by experience.
But the standard goes beyond just a respectful nod by
requiring organizations to maintain that knowledge for
future use, as necessary.
The words to the extent necessary in clause 7.1.6 are
not the loophole implied. Often, an organization uses
those or similar words to avoid part of a standard require-
ment by stating it was determined unnecessary.
When an organization now enters retraining as its
CAPA for an investigation, that organization admits that
the knowledge for training employees is required for daily
operations. If that knowledge werent required, employees
could inherently perform the function, and there wouldn't
have been a failure or need to investigate.
If I was auditing an organization that had entered train-
ing as a CAPA for an investigation, I would respond:
++ You have determined that training is required to correct
and prevent recurrence of this issue. Show me the
documented knowledge determined necessary for
this operation that has been or will be provided to the
employee (to show compliance with clause 7.1.6).
++ Show me how you have or will determine the employee
is competent to perform this work (to show compliance
with clauses 7.2(a) and 7.2(c)).
Combining clauses 7.1.6 and 7.2 requires an organization
remember its past and document those lessons to pass to
its future.
REFERENCE
1. George Santayana, The Life of Reason, 1905.
Paul E. Boyers is the CEO of Quality Consultants and
Investigations in Corpus Christi, TX. He has a bachelors
degree in business management from the University of
Phoenix. A member of ASQ, Boyers is an ASQ-certified
quality auditor.
 Quality Roundtable
ENTERPRISE
MEMBERS
3M Company Deere & Company Johnson Controls Inc.
Abbott Laboratories Defense Contract L3 Technologies
Abbvie Management Agency Lockheed Martin
Adient The Dow Chemical Mattel (Fisher Price)
Altria Company Microsoft Corp.
Anheuser-Busch Inbev Defence Research NOAA National Marine
Ansell Healthcare LLC & Development Fisheries Service
Apple Inc. Organization Northrop Grumman Corp.
Baxter International FDA/CDRH Office of the Plexus
BD Center Director Procter & Gamble
Bechtel FedEx Corp. Raytheon
BMW Manufacturing Ford Motor Company Schweitzer Engineering
Co. LLC General Electric Labs Inc.
The Boeing Company General Motors Tata
Booz Allen Hamilton Hewlett Packard Enterprise TE Connectivity
Brunswick Corp. Honeywell Textron
(Mercury Marine) HP Inc. UTC
Caterpillar Inc. Intel Corp. VF Corp.
Cisco Systems Ivy Tech Community College

Congratulations to these organizations who have pledged their

commitment to quality by becoming ASQ Enterprise Quality
Roundtable members. Learn more about these membership
types, and the benefits, by visiting asq.org/organizations.
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