DETOXIFY YOUR

WORK ENVIRONMENT 14
REDUCE RESISTANCE
TO CHANGE 26
QUALITY PROGRESS
CAN YOUR CAPA SYSTEM
BE MORE EFFECTIVE? 40
T H E O F F I C I A L P U B L I C AT I O N O F A S Q

J U N
QUALITYPROGRESS.COM

2 02 1
Building engagement
to achieve quality
outcomes
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A THANK YOU TO OUR SPONSORS!
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CONTENTS
June 2021  VOLUME 54 NUMBER 6

COVER STORY

16 || Engineering
Engaged
Employees
If you engage and take
care of your employees,
they will take care of your
business and customers.
by Santosh Mishra
and Dennis Delgado

40 || Essential
Evaluation
Don’t overlook evaluating
the effectiveness of your
corrective and preventive action

FEATURES
32 || Course of Action
There’s a basic four-step process to begin
enterprise strategic planning, which must
consider organizational culture.
by Casey Bedgood
plan to ensure the solutions
implemented are effective
and working.
by José Rodríguez-Pérez and
DIGITAL EDITION Manuel E. Peña-Rodríguez
QP is now available in
a new digital format to
make it easier to access
the quality information
you need on the go.
Make sure to log in
to view the link.

26
Fear of the Unknown
Learn the keys for successful
change management—which
include addressing organizational
culture—and advice for better
managing resistance to change.
by Santosh Mishra and
Natella Isazada

qualityprogress.com || QP || 3
CONTENTS
June 2021 VOLUME 54 NUMBER 6

05 || Foreword 13 || Mr. Pareto Head

06 || Seen & Heard 14 || Career Coach

Editor in Chief and Publisher Design
Removing toxicity and hostility Seiche Sanders GLC glcdelivers.com
08 || Expert Answers from your workplace and your life. ssanders@asq.org
Media Sales
Taking on missing training records. Senior Editor SmithBucklin
46 || The Download Mark Edmund 866-277-5666
10 || Progress Report Data quality is the cornerstone of 4.0. medmund@asq.org
Editorial Offices
Quality could help boost Assistant Editor 414-272-8575
Lindsay Pietenpol
election integrity. 51 || Field Notes lpietenpol@asq.org
Mail
Quality Progress/ASQ
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57 || Standard Issues
The major revisions to the aerospace Article Submission Process
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4 || QP || June 2021
 F O R EW O R D TH E QUAL IT Y INSIDE
QUAL IT Y PROGRE SS

Sue Peiffer, HSHS Sacred Heart

Hospital

Culture
L S T R AT EGY
O RG A N IZ ATI O N A

L S TR AT EGY
O RG A N IZ ATI O N A

Grace Duffy JUST THE FACTS

Management & Performance

When developing
strategic plans,
organizations must
look well beyond the
next three to five
years. At the same
time, organizations
must be able to
pivot and evolve

Systems
their strategic plans
in real time (within
reason) to remain
viable.
Enterprise Strategic planning
strategic must be methodical,
well thought out,
planning for inclusive of the
the 2020s and right stakeholders
and aligned with
beyond requires customer expecta-
a heavy dose of tions. There’s a basic
transformation  four-step process
to begin strategic
by Casey Bedgood planning.
An important
element to
this planning is

Jane Keathley
organizational
culture. Strategy
is just a theory
CHAN
GE MA
NA GEME
unless interwoven
NT into organizational
culture. Long-term
organizational
change will only be
achieved through

FEAR
culture transfor-
mation, which is
predicated on vision,
mission, values and

Keathley and Company, LLC

trust.

CHAN
GE MA
NA GEME
NT

qualityprogress.com
|| QP || 33

32 QP || June 2021

Shock
||

Frank Murdock JUST THE

FACTS

ASQ’s Vision
In today’s world
of
volatility, uncertainly,

FKM Consulting, LLC

complexity
ambiguity, and
is inevitable.change
many changeBut
initiatives are
with employee met
tance. The resis-
comfortablemore
and
invested employees
are in the
state, the current
OF THE

ASQ will be the thought

they are tomore likely

UNK
anything that resist
GEME
NT change that. may
ENGA
OYEE
EMPL
Resistance
eliminated, can’t
but it
be
can be reduced
the right approach. with

Allen Wong
The authors
the key componentaddress
of successful
management,change
provide tips and

leader and community

advice for and
managing better
to change. resistance

NO
G
EERIN
NT
GEME
OYEE
ENGA Managing
employee

ENGIN
EMPL
resistance

Getty Images
by Santosh to change
Mishra and
Natella Isazadainitiatives 

AKW Consulting, LLC

MirageC via
26

WN
|| QP || June 2021

of choice for individuals

GED
ENGA

YEES
EM PLO
qualityprogress

and organizations seeking

.com || QP || 27

GCC
to add strength
your people  
Power to your quality programDelgado
to and Dennis
Mishra

excellence through quality.

by Santosh

FACTS
JUST THE

Nancy Nouaimeh
outlines
The authorcorrelation
of the high quality
return 120%in value
are your their salary between
Employees and employee and
most important to the organiza-
take tion. Employeealso engagement,
asset. If you they what you can
do
care of them, engagement
to ensure your
of
will take care and is key to a strong
culture are
sustainableand the employees con-
your business emotionallytheir work.
customers. of quality, services
of nected to
that quality
Research shows and products.
engaged employees

Abela & Co.

Images
via Getty
Dimitri Otis
17

ASQ Administration
||
|| QP
ss.com
qualityprogre

Leigh Ann Schildmeier

|| June 2021

CHIEF EXECUTIVE
16 || QP

OFFICER Ann Jordan Park Avenue Solutions

Edwin Garro
Ride the tide of change by forging a rock-solid culture
CHIEF OPERATING
OFFICER PXS Performance Excellence
Sid Bhatnagar Solutions or most people, the So while culture transcends clear

CHIEF FINANCIAL
OFFICER Jim Monnat
CHIEF COMMERCIAL
OFFICER
Andrew Schroeder
CHIEF MEMBER
SERVICES OFFICER
Kristen Spriggs
ASQ EXCELLENCE,
INC. CEO
Jim Templin
Senior Leadership
CHAIR
Janet Raddatz, Sargento
Foods (retired)
CHAIR-ELECT
A. Blanton Godfrey, North
Carolina State University
PAST CHAIR
Austin Lin, Google
TREASURER
Wayne Brown, retired
aerospace executive
and industry advisor/
consultant
Directors at Large
Linda Andrade Gonzalez
KSR International
Jami Kovach
University of Houston
Paulo Sampaio
University of Minho
Glenn Walters
New Mexico Small
Business Development
Center Network
TCC
Wanda Sturm, RGP
Michael Kirchner
Retired
Therese Steiner
LexisNexis
John Conner
DRT Aerospace
QP Editorial Review Board
Randy Brull, CHAIR
Administrative Committee
Brady Boggs, Randy Brull,
Jim Jaquess, Scott Laman,
Lou Ann Lathrop, R. Dan Reid,
Richard Stump
Technical Reviewers
Naveen Agarwal, Ashraf Ali, Suresh
Anaganti, Zubair Anwar, M. Onur Artan,
N.T. Balakrishnan, Aditya Bansal, Andy
Barnett, Matthew Barsalou, Brooks
Carder, Bernie Carpenter, L.N. Prabhu
Chandrasekaran, Ken Cogan, Rucha
Deshpande, Ahmad Elshennawy, Brian
Galli, Sureshchandar G.S., Brenda
Georgensen, T. Gourishankar, Tolga
Göcer, Roberto Guzman, Lynne Hare,
Gary Jing, Trevor Jordan, T.M. Kubiak,
William LaFollette, Denis Leonard, Pradip
Mehta, Arvind Parthasarathy, Stephanie
Parker, Larry Picciano, Gene Placzkowski,
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Rana, Narahari Vittal Rao, James Rooney,
Ayman Sakr, Anusha Selvakumar, Abhijit
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Sille, A.V. Srinivas, Herman Tang, Tiea
Theurer, B. Vaithiyanathan, Manu Vora,
Denise Wrestler, Doron Zilberstein
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.
F
COVID-19 pandemic
profoundly altered
the way they work,
especially for those
who started or still are working from
home. And you’d think—based on all
the sourdough-making, pet-adopt-
ing, family road tripping and puzzle
piecing—that people would have a
lot more time on their hands. While
that may be the case (is it just me,
or does dressing from the waist up
cut your morning routine in half?),
it turns out people still are stressed.
And the cause might surprise you.
A new survey reveals that 41%
of U.S. workers feel exhausted,
overwhelmed and burnt out from
chronic workplace stress. You can
find more results from the study on
page 12, but what struck me about
the findings is that the root cause
of most of the stress leads back to
organizational culture—the heart
of any organization and theme of
this month’s issue.
“Engineering Engaged Employ-
ees,” p. 16, stresses the importance
of ensuring employees are tended
to and cared for. Employees, in turn,
will take better care of custom-
ers, driving improved results.
The authors contend that quality
is a direct byproduct of engaged
employees, and these efforts are
propagated by strong leadership.
definition, there are very decided
steps you can take toward improv-
ing your organization’s culture.
This article explains exactly how.
“Fear of the Unknown,”
p. 26, addresses another cul-
ture-​centric topic: change
management—​something every
organization is grappling with
these days. All levels within an
organization must be actively
engaged in any change initiative or
it will undoubtedly fail. This article
includes helpful advice and guid-
ance for overcoming resistance and
engineering successful outcomes.
“Course of Action,” p. 32, details
a four-step process for strategic
planning, which forms the under-
pinnings of your organizational
culture and change efforts. While
long-term strategic plans serve as
a necessary roadmap for continued
success, organizations must remain
agile and change course constantly
to accommodate a rapidly changing
environment.   QP
Seiche Sanders
Editor in Chief
and Publisher

qualityprogress.com || QP || 5
SEEN HEARD &
READER REACTIONS FROM AROUND THE WORLD

A CLOSER LOOK
In response to “Expert Answers: April 2021” (p. 6):

Unfortunately, the answer [to whether W. Edwards

Deming invented the plan-do-check-act cycle] is
neither full nor exact. Walter A. Shewhart’s cycle
had three steps: specification, production and the plan-do-check-act (PDCA) cycle,
inspection. But it was just Shewhart who gave a they gave names (letters) to the steps
sound explanation as to why the variability of all of Deming’s wheel.
processes requires a cycle instead of a straight line. The difference between PDCA
So, in the quality world, Shewhart is the inventor. and plan-do-study-act is the interpre-
Deming drew a four-step cycle in his famous 1950 tation of what’s most important. The
lecture, but—as the expert outlined—the letters letter “C” (check) could be interpreted
“PDCA” were absent from that drawing. However, as closer inspection, while Deming
the essence of the corresponding actions were insisted on studying the results.
presented there. So the Japanese did not invent Vladimir Shper, Moscow

THE REACTION GAUGE

THIS MONTH’S QUESTION
According to a recent survey, 41% of U.S. workers feel exhausted,
overwhelmed and burnt out by chronic workplace stress. For about
one-third of employees, their work-related stress is so extreme it
affects their personal lives, too. While a supportive organizational
culture can help employees maintain a healthy work-life balance,
many organization ignore the issue. How do you manage workplace
stress? What does your organization do to foster a healthy work-
life balance?
. It’s been almost a year now that I have been working from home,
MARCH’S QUESTION
When the COVID-19 pandemic hit, many organizations transitioned
to remote work. Some already had the infrastructure in place to
make the switch, but many didn’t and had to figure it out on the fly.
Prepared or not, working remote for an extended period of time can
be difficult when you’re used to working face to face. What are some
of the challenges of remote work? What are some benefits? How has it
changed the way you communicate and interact with your coworkers/
managers/employees? How has it impacted productivity?
Sameer Choughule, Dubai, writes:
Honestly, I am not a fan of working from home, or remote working.
In the initial few months, it was nice to be near family more, work
from the comfort of my home and have the liberty to do other chores
that usually don’t get my time. Eventually, though, I missed meeting
colleagues for healthy face-to-face discussions and being able to
concentrate better in the workplace.
and it is getting increasingly frustrating for me. Personally, I would
jump at the chance to return to the workplace.
Join the discussion on myASQ at my.asq.org,
or on LinkedIn at www.linkedin.com/company/asq.

6 || QP || June 2021
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EXPERT ANSWERS
S U B J E C T M AT T E R E X P E R T S TA K E O N YO U R Q U A L I T Y- R E L AT E D Q U E R I E S

new training, document the training

and monitor its effectiveness.
THIS MONTH’S QUESTION This is where I would draw a line,
though. Management systems should
not be implemented to superficially meet
What is a best practice for requirements or just to obtain ISO 9001
addressing missing training records certification—organizations should real-
for existing employees? My organization ize financial and economic benefits from
will be seeking ISO 9001 certification this year, and departments implementing the management system.
often hold informal training for their processes but don’t generate If your product, process and system are
training records. New employees aren’t an issue because measures ineffective and are not meeting goals
have been implemented to ensure training records are generated and objectives, you should be willing to
and retained for new hires. go above and beyond ISO 9001 require-
ments to meet your business goals.
After you get past this issue and
operationalize your management
If the missing training records are system, and in the spirit of having an
OUR RESPONSE
for product, process or system-related effective management system, explore
knowledge, you could explore a few ways to make training administration
his is a common situation. options. One commonly used approach and record keeping simple and easy to

T
Even mature, well-established
organizations fail to capture
training records. When
an organization applies
for ISO 9001 certification, there is
an agreed-on effective date for the
implementation. If you started imple-
menting ISO 9001 requirements in the
past six months or year, for example,
the starting point is when your effec-
tive implementation starts. You do not
have to demonstrate your compliance
to management system requirements
beyond this starting period.
That said, there may be other legal,
regulatory or statutory requirements that
are independent from whether you have
implemented ISO 9001. These require-
ments might necessitate training records
for a retention period that must be met.
I suggest evaluating the following
for experienced employees with miss-
ing training records: If the missing
is grandfathering. As long as the indi-
viduals who are missing records have
the required qualifications and experi-
ence to perform their responsibilities
effectively, you may exempt them from
the training record requirement for
a certain period. You cannot exempt
them from documenting training
records in perpetuity, though. This may
be applied as a one-time correction of
the situation. Future training would
require documented training records
consistent with organization manage-
ment system requirements.
The other approach is more fact
based. If you can retrieve the outputs
of the experienced employees and
analyze their product and process
quality records, you may be able to
assess whether they require training
irrespective of satisfying ISO 9001 or
organizational system requirements.
If your product and process quality
implement. For example, offer group
training for experienced employees
and issue one record that provides
proof of training for all attendees
instead of creating individual records.
You also could create a self-reporting
training and professional development
portal where employees report their new
skills and knowledge acquisition. Shar-
ing the names of the high-performing
employees in a newsletter or on the
organization’s intranet may motivate
others to follow suit.  QP
BIBLIOGRAPHY
International Organization for Standardization
(ISO), ISO 10014:2021—Quality management
systems—Managing an organization for quality
results—Guidance for realizing financial and
economic benefits.
ISO, ISO 9001:2015—Quality management systems—
Requirements.
iStock.com/TarikVision

training records are required for legal, records indicate that quality, safety,
regulatory or statutory requirements, productivity and other key perfor- This response was written by Govind Ramu,
conduct a group training and generate mance indicators are not meeting manager business process excellence, Google LLC,
a record of evidence. goals and expectations, conduct a Mountain View, CA.

8 || QP || June 2021
 A digest of trends, research & late-breaking news

ASQ

Electo ral QMS Needed to

Boost Election Integrity
laims of election fraud, assertions of suspi-

C
cious recounts and charges of vote dumps.
Cyberthreats to the election process, partisan
litigation disenfranchisement, gerrymandering
and misinformation campaigns.
There’s no question that the controversies surrounding
U.S. elections since 2000, as well as last year’s historic U.S.
presidential election, have created an unprecedented level of
public mistrust around U.S. elections and contributed to the
perceived decline in the integrity of the U.S. electoral system.
For instance: iStock.com/samiph222/SergeiKorolko/Vladyslav Bobuskyi/johnwoodcock

– A survey by researchers from a university consortium of

Northwestern, Harvard, Northeastern and Rutgers late last
year found that, overall, 38% of Americans said they lacked
confidence in the fairness of the 2020 presidential election.1
– A Gallup poll before the November elections found that
59% of Americans said they didn’t have confidence in the
honesty of elections.2
Members of the ASQ Election Excellence Group know
the gravity of the situation and think there’s at least one
way to address these difficulties and restore some faith
in U.S. elections: quality management.
“When a democracy works well, it can foster greater levels
of peacekeeping, human development, economic growth,

10 || QP || June 2021

human rights, civic engagement,
and the exchange of new and innova-
tive ideas,” the group’s authors wrote
in a recently released position paper.
“There is an urgent need to address
the shortcomings and risks that cur-
rently afflict U.S. electoral processes.
Quality management provides an
effective and proven solution.”
In the position paper, the group
outlines the risks impeding the
integrity of U.S. elections and advo-
cates for the adoption of an election
quality management system (QMS)
in U.S. jurisdictions based on ISO/
TS 54001 and ISO 9001.
“A standardized electoral QMS
can improve election procedures
and operations, thereby bringing
transparency to, and restoring con-
fidence in, election results,” wrote
the paper’s authors, who include
prominent ASQ members, subject
matter experts and representatives
of the ASQ Government Division.
“Increasing public mistrust of
U.S. elections is a significant threat
to democracy. The pursuit of elec-
tion excellence through an electoral
QMS based on ISO/TC 54001:2019
would foster greater election integ-
rity and bolster the legitimacy of
democratic processes in the U.S.,”
the authors wrote.
 Visit asq.org/quality-resources/
research to download the 10-page paper,
titled “Advancing a Quality Management
System for U.S. Elections.” There, you also
can access other ASQ original research,
including “Quality’s Impact on the Global
Pandemic Response.”
REFERENCES
1. Stephanie Kulke, “38% of Americans
Lack Confidence In Election Fairness,”
Northwestern Now, Dec. 23, 2020,
https://tinyurl.com/3zskkh43.
2. Alexa Lardieri, “Majority of Americans
Don’t Trust Elections, Poll Finds,”
U.S. News, Feb. 13, 2020,
https://tinyurl.com/k6hku8n7.
AUTOMOTIVE
Chip Shortage
Causes Automakers
To Hit Pause
As the global semiconductor shortage
continues, several automakers—including
General Motors, Toyota and Ford—have sus-
pended production and extended downtime.
Semiconductor chips are used throughout
vehicles for things such as in-car entertain-
ment, driver assistance and warning systems,
navigation and battery management.
Dan Hearsch, managing director at the
global consulting firm AlixPartners, said
automakers are trying to protect their truck
and SUV plants, which typically bring in the
most revenue.
“All the [original equipment manufacturers]
are working very hard to try and keep the
pickup trucks, large SUVs, the high-value,
STEM
WEST IS BEST FOR WOMEN
LOOKING FOR STEM JOBS
Western U.S. cities seem to be the best spots
for women to land science, technology, engi-
neering and math (STEM) jobs, according to
a recent ranking. New York City took the top
spot and Chicago came in at No. 7, but cities
out west rounded out the top 10, including:
– San Francisco.
– Seattle.
– San Jose, CA.
– Fremont, CA.
– San Diego.
– Oakland, CA.
– Oxnard, CA.
– Los Angeles.
high-revenue, high-profit models running,”
Hearsch said. “And when you see that they
can’t do that, that is your indication of just
how difficult this is.”
According to the Alliance for Automotive
Innovation, a lobby group and trade associ-
ation, 1.3 million vehicles could be lost due
to the shortage. AlixPartners estimates the
crisis will cost the auto industry $61 billion.
 Read more at https://tinyurl.com/
chip-shortage-automakers.
The cities were ranked after reviewing
median income data for female STEM
employees, the share of women in manage-
ment positions, unemployment rates, as well
as many other variables. The full ranking
includes the 120 U.S. cities with a population
of at least 200,000.
 For further details on how the
rankings were compiled, more specific
results and a regional break-
down of top cities—which was
compiled by CommericalCafe,
a real estate research group—
visit https://tinyurl.com/j2km5t5d.
qualityprogress.com || QP || 11

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QP wants to showcase the best and brightest young talented
quality leaders and trailblazers of tomorrow. If you or someone
you know is young, passionate and a rising quality leader who is push-
ing boundaries and making a difference in quality—let us know.
Nominate your boss, an employee, a colleague—or yourself. Submit
your nomination at asq.org/quality-progress/under-40-nomination
before June 30.
In the nomination form, be sure to present the most significant
accomplishments and attributes of your nominee, along with
other observations. Nominees must be 40 or younger and display
professionalism, potential and a passion for quality.
Individuals will be highlighted in the November issue of QP.
SURVEY
Workplace Stress Hits U.S. Employees Hard
More than a year after the pandemic started, COVID-19 has
taken a toll on so many parts of people’s lives. Now, a new survey
finds that 41% of U.S. workers are feeling exhausted, overwhelmed
and burnt out by chronic workplace stress.
The research found that 87% of employees said their job affects
their mental health, yet only 17% of workers feel their organiza-
tions make mental health a priority.
The survey of 1,000 Americans (working from home
for an organization that has office space or working in
an office most of the time) also found that work-
ers were reluctant to take off days using their
allotted time. Just 14% of workers took all of
their vacation days in 2020, despite the fact
that 28% can’t roll unused days into the new
year. Other findings include:
– 37% of employees are experiencing job
stress that’s so intense that it frequently
affects their personal life.  mental-health-2021.
12 || QP || June 2021
NEWS BRIEFS
There’s a new ASQ conference focused on building leadership skills for
quality professionals. The inaugural ASQ Leadership Conference, which
takes place virtually on July 15, explores how quality professionals at any stage
of their career can seek to influence, affect and inspire creation of meaningful
change and lasting improvements in an organization’s culture and operations.
The conference will offer insights into individual value, keys to leadership,
methods of inclusivity and empowerment, and adapting to change.
 For more details, visit www.asq.org/events.
More than half of all manufacturers will be
testing or using fifth-generation cellular wire-
less technology (5G) in some way by the end
of 2021, according to a new study from the
Manufacturing Institute. Other results from
the survey include:
– 91% of manufacturers said they believe 5G connectivity
will be important to the overall future of their businesses.
– 91% of manufacturers indicate the speed of 5G deployment
will have a positive impact on their ability to compete globally.
– 88% of manufacturers indicate 5G connectivity will allow engi-
neers to troubleshoot remotely.
The institute surveyed 105 manufacturers to develop the whitepaper,
titled “How 5G Is Transforming the Manufacturing Landscape.”
 Visit https://tinyurl.com/86v4w2a4 to download the 44-page report.
– 40% of people agree that remote work supports better work-life
balance—yet remote workers struggle to prevent work from
bleeding into nights and weekends. 
– 60% of people agree taking mental health days is important,
but the average worker left seven days of unused
vacation time at the end of 2020. 
Without a supportive organizational
culture, burnt-out employees are
iStock.com/IIIerlok_Xolms/bagotaj/Alina Kvaratskhelia
unlikely to enact the work-life balance
they need, researchers wrote. Orga-
nizations that ignore this problem
can face costly losses, disruptive
turnover and an ailing workforce
that struggles to remain productive.
 For more from this survey, developed by
Clever, visit https://listwithclever.com/research/
GETTING TO KNOW…

Jon McLaughlin Dedhia Tabbed

CURRENT
POSITION
Field services manager, East Coast Metrology (ECM),
Topsfield, MA.
As Professional
Bachelor of science degree in mechanical Of the Year
EDUC ATION engineering, University of Massachusetts
(UMass)-Lowell. Long-time ASQ contributor and quality
thought leader Navin S. Dedhia has been
named this year’s Quality Magazine Professional
During college, there was a machine shop class in which we learned to machine of the Year. Over the course of his illustri-
Introduction
parts on a Bridgeport milling machine. Next, we checked the parts using hand
to quality: ous 50-plus years in quality, the ASQ fellow
tools such as calipers and micrometers.
has published two books and more than 50
Peter Avitable was a mechanical engineering professor of mine at UMass-Lowell technical papers and 100 articles, given more
A teacher who
who influenced me because he stressed the importance of paying attention to than 75 presentations and taught many quality-​
influenced you
detail. He instilled in me the importance of presenting a report in an organized related courses.
more than others:
and meaningful way, always making sure that attention is paid to the details.
He adds this latest honor to his collection
A mentor who has of 20 prominent awards, including two ASQ
Gary Confalone gave me my first career opportunity after college and has set
made a difference medals (the Distinguished Service Medal and
me up for success in the metrology industry.
in your career: the Lancaster Medal),
Best career advice: Money is not everything. Feeling fulfilled and challenged is more important. the Asian Pacific
Noteworthy Quality Organization
I am Coordinate Metrology Society level-one certified. Harrington-Ishikawa
outside activities:
Medal, the ASQ Inspec-
“Tracking the Tokamak—The Holy Grail of Renewable Energy,”
Published work: tion Division’s Lessig
a case study published by ECM detailing one of the longer jobs I worked on.
Award, the ASQ Los
Recent award: ASQ Inspection Division’s 2021 Inspector of the Year. Angeles Section’s Simon
Favorite ways Watching movies or NFL games, going on nature walks and hikes, Collier Quality Award,
to relax: and hanging out with family and friends. and the Kachchhi Oswal
Books currently I am reading Dune, the 1965 science-fiction novel by Frank Herbert. Jain Association in
reading: My favorite authors include J.R.R. Tolkien and Philip K. Dick. North America Lifetime
Achievement Award.
“Don’t lose sight of the fact that your quality findings can have massive
repercussions. As routine as some inspections may appear, the instant
Quality quote:  Read more about Dedhia’s award
you become complacent, mistakes will be made, and in this line of work,
mistakes cannot happen.” at https://tinyurl.com/ke8nc3w6.

Mr. Pareto Head b y M i k e C r o s s e n

qualityprogress.com || QP || 13
CAR EER COACH
Be the
Change You
Want to
See
he COVID-19 pandemic has
T
changed some people’s behav-
ior and attitude toward others.
In some situations there were
positive changes; in others, the
changes were damaging or destructive.
It often is unclear why situations
such as a pandemic can change people.
Whether out of fear of risk or liability,
many groups that used to help the com-
munity stopped. Soup kitchens and meal
delivery services, for example, were
limited or nonexistent. Community clos-
ets, which provide warm, clean clothing,
weren’t open. Even compassion for oth-
ers seemed to dwindle. In communities
and workplaces, human behavior spun
180 degrees in the opposite direction.
14 || QP || June 2021
A DV I C E TO A DVA N C E YO U R C A R E E R
WORKPL ACE ENVIRONMENT
Surviving hostility in
an unpleasant world 
by Teresa Whitacre
Stressors related to the pandemic,
and the changes those stressors forced,
really can wear on you. Organizations
and employees have had to adapt in
ways never before seen. And quality
professionals aren’t immune to the
stressor effects. People in leadership
roles, especially, must be cognizant
of how behaviors affect them, and
those who report to them. If you once
were pleasant to be around but now
are a miserly grouch, you must look
at why. How has your situation or life
been affected to create such a drastic
change in your behavior or personality?
Over the past year, the world has
experienced a swift change toward
hostility and toxicity. The pressures
and changes of the pandemic affected
many of us in ways we aren’t used
to. Have you been in a toxic situation,
whether personal or professional? Did you
or could you recognize whether you were?
What is going on around us and how we
are treated by others often changes our
behaviors without us realizing it.
The focus of this column is on hostile
and toxic workplace situations, but most
of these examples also apply outside of
the workplace.
iStock.com/Anzhelika Poltavets
Pay attention to yourself
We often experience changes in our-
selves without realizing it because they
happen subtly. Are you sleeping more or
less than usual? Have there been major
changes in your diet? Has your mood
or thought process changed signifi-
cantly and remained that way? Ask your
coworkers if they've noticed changes in
you. If you can’t see the changes in your-
self, those close to you often can.
If you see signs that you have
changed, seek the appropriate pro-
fessional or medical assistance. Early
intervention can help rectify the issue.
Break it down with root cause
analysis and five whys
If you have identified changes in
yourself, next look at why those things
happened. Perhaps you are in a toxic,
hostile or bad environment. Being
subjected to such environments
can cause mental, physical and
emotional health issues.
Research shows that tak-
ing certain types of actions,
or being subjected to
those actions, can con-
tribute to health issues.
These actions include:
– Not providing the needed
feedback to timely correct
a problem or solve an issue.
– Being excluded from meetings
that you should be part of.
– Being the subject of, or partic-
ipating in, peer group gossip
about performance.
– Being completely exhausted
and having no energy for pursuits
you used to enjoy.
– Publicly humiliating your staff
or group members, or allowing
it to happen.
– Giving or getting only criticism,
never praise for something well done.
– Having or being a micromanager.
– Finding it difficult to get up in
the morning.
– Playing the blame game.
Teresa Whitacre is a senior quality engineer and principal at Marketech Systems in Pittsburgh. She holds a bachelor’s degree in organizational
leadership from Ashford University (now called the University of Arizona Global Campus) in San Diego, CA. She is an ASQ-certified quality
auditor, engineer, Six Sigma Green Belt, and manager of quality/organizational excellence. An ASQ fellow, Whitacre is an instructor for ASQ’s
Pittsburgh Section’s certified quality inspector refresher course and past deputy regional director for ASQ Region 8.
– Participating in or being a victim
of gaslighting.
– Finding that whatever you do is never
good enough, in any situation, even if
you do it exactly as you were asked to.
Gather data and look for
solutions
Have you experienced any of the
situations in the break-it-down stage
as an employee? Have you taken any of
these actions as a manager? Have these
Detach from the toxicity
through social time,
getaways, hobbies,
exercise or volunteering,
for example.
things happened to you as a participant
or leader in an organization? If you saw
yourself in any of those actions, think
like a quality professional: Gather data
and look for solutions.
Document everything. No matter
how small you think the item is, write
it down. In times of stress, we often
don’t remember everything. Writing
things down can help you gather your
thoughts and serves as documenta-
tion for later events, such as personnel
reviews, committee meetings
or investigative reports.
Detail and report specific inci-
dents. As you are documenting
things, list as many details as you
can, such as times, dates, places
and people—just like you would in
an audit report. Who, what, when,
where, why and how are all import-
ant facts when looking for solutions.
Look introspectively. After you have
gathered data, what changes would you
recommend? What solutions do you see?
Research shows that emphasizing respect
and professional interactions helps.
Regardless of your role in the organi-
zation, set the stage: Treat others as
you want to be treated, and realize
that what you promote is what
you permit. What you allow
to happen is what occurs.
The most difficult thing
is to stop negative self-talk.
Stop telling yourself you
deserve this kind of behavior.
Instead, tell yourself what you
are worth. Review what you
wrote out and set clear, actionable
goals for talking yourself into trying
something or working on something
rather than out of it. Instead of believ-
ing that you are not good at something,
try it and prove to yourself that you are.
Take care of yourself in whatever
way works best for you. Detach from the
toxicity through social time, getaways,
hobbies, exercise or volunteering, for
example—anything that changes your
thoughts and provides positive change.
Work on an exit strategy to remove
the toxicity or hostility from your life.
Remember the most important solution
is the outcome that is best for you.  QP
EDITOR’S NOTE
A bibliography of resources used for this column can be
found on this column's webpage at qualityprogress.com.
qualityprogress.com || QP || 15
 EMPLOYEE ENGAGEMENT

Dimitri Otis via Getty Images

16 || QP || June 2021
 EMPLOYEE ENGAGEMENT

ENGINEERING

ENGAGED

E M P LOY E E S

Power to your people to add strength

to your quality program 
by Santosh Mishra and Dennis Delgado

JUST THE FACTS

Employees are your return 120% of The author outlines

most important their salary in value the high correlation
asset. If you take to the organiza- between quality
care of them, they tion. Employee and employee
will take care of engagement also engagement,
your business is key to a strong and what you can
and customers. sustainable culture do to ensure your
of quality, and the employees are
Research shows that quality of services emotionally con-
engaged employees and products. nected to their work.

qualityprogress.com || QP || 17
 EMPLOYEE ENGAGEMENT

T wo quotes highlight the importance of employee engage-

ment in an organization. One is from Richard Branson:
“Clients do not come first. Employees come first. You take
care of your employees, they will take care of the clients.”1
The other is from Jack Welch: “There are only three
measurements that tell you nearly everything you need to
know about your organization’s performance: employee engagement,
customer satisfaction and cash flow.”2
Furthermore, the relationship between quality and employee
engagement is highly correlated, and the quality of any service
or product depends greatly on how engaged employees are.
Creating an emotional connection to the work is at the heart
of taking employees from simply being satisfied to being engaged.
That is a far cry from what employers
really want: engaged employees. Engaged
employees go beyond what simply is
required for the job and expend energy
to solve problems, delight customers and
reach organizational goals. And the best
part is they do it because they want to.
In this article, we draw from our expe-
riences and exposure to quality, and from
observing the direct consequences of services
and products provided to customers from
engaged and disengaged employees—the
latter having catastrophic consequences for
According to Brent Gleeson, “Today, more than ever, organizations businesses. Supported by data, we dwell on
rely on the energy, commitment and engagement of their workforce to what employee engagement means, why it is
survive in the 21st century. As a former Navy SEAL, I can assure you so important for quality and what can be done
that one of the fundamental reasons we continue to dominate our bat- to develop the workforce to be fully engaged,
tlefields is due to the fact that we have 100% employee engagement.”3 which leads to a superior quality culture.
To understand the importance of employee engagement to qual-
ity, we first must understand what an engaged employee means. What is employee engagement?
An engaged employee is different from a satisfied employee. A satisfied First, we must understand what employee
employee may like his or her job a lot and have no intention of leaving it, engagement is. Only then can we explore its
but he or she does only what is necessary to keep it. importance to quality and what we can do
about it. The best way to explain employee
engagement is by using Abraham Maslow’s hierarchy of employee
engagement model—from being disengaged (survival) up to being
highly engaged (self-actualization). (See Figure 1, p. 20.)
Employee engagement has been and is being talked about
animatedly the world over as if it is the newfound key to
business success. So, where did it start? The first pub-
Engaged employees go lished mention of the term “employee engagement” was
beyond what simply is in William Kahn’s 1990 paper, “Psychological Condi-
required for the job tions of Personal Engagement and Disengagement.”4
The best organizations build and sustain a cul-
and expend energy to ture of engagement, led by CEOs who understand
solve problems, delight that employee engagement is not just nice to have,
customers and reach but critical to achieving business results. Leaders
in these elite organizations also understand that
organizational goals. employee engagement primarily is their responsibility.
Employee engagement is a heightened emotional
connection that employees feel for the organization,
which influences them to exert greater discretionary effort
to their work. Employee engagement rates go up exponentially
when there is a clear correlation between employee action and

18 || QP || June 2021
 EMPLOYEE ENGAGEMENT

Signs of Engagement
Tell-tale signs of an engaged workforce include:
– A shared vision of the organization across the
business and goal congruence at all levels.
– High growth and profits.
– Delighted and happy customers;
customer concerns are resolved quickly.
– A high level of trust and mutual respect.
– Faster decision making.
– Absence of fear.
– High-performing teams.
– A focus on continual improvement.
– Innovative ideas are encouraged and acted upon.
– Transparent operation and internal communication;
employees find ways to save resources.
– High energy all around.
– High accountability in operations.
– No favoritism.
– No water cooler gossip.
– Low employee turnover.
– Employees volunteer to take on extra work.
– “That is not my job” is not heard.
– Volunteering in the community is fostered.
—S.M. & D.D.

organizational success. The bottom line is that employee engagement affects any
organization’s bottom line (see Figure 2, p. 21).
An engaged employee is defined as one who is fully absorbed by and enthusiastic
about work, and who takes positive, proactive actions to further the organization’s
reputation and interests. Engaged employees work with passion and care deeply about
the organization’s success. They drive innovation and are emotionally invested in
committing their time, talent and energy to add value to their team and advance the
organization’s initiatives.5
As author and inspirational speaker Simon Sinek said, “No customer will ever love
a company until the employees love it first.”6
Creating an emotional connection to the work is at the heart of taking employees
from being satisfied to being engaged. In many ways, an engaged workforce is the holy
grail of the business world and has proven just as elusive. So, this begets the question:
Are we attacking the symptoms rather than the root cause?
According to Axero, an intranet software company, a 5% increase in employee
engagement is linked to a 3% increase in revenue growth in the subsequent year. Also,
65% of employees in the United States and 87% of employees worldwide are engaged
in their work. Engaged employees give 3.9 times the earnings per share. On the flip side,
David Crockett via Getty Images

unhappy U.S. workers cost U.S. businesses $550 billion annually in lost productivity.7, 8
Furthermore, employee turnover costs U.S. organizations $1 trillion,9 and Deloitte
found that organizations with effective recognition programs reduced their voluntary
turnover by 31%.10 (See Figure 3, p. 22.)
According to the Canada Human Resource Centre, 89% of Candidian employers
believe that employees leave their organization for more money, when in reality,

qualityprogress.com || QP || 19
 EMPLOYEE ENGAGEMENT

only 12% of employees actually do leave because they want
more money.11
Also, fully engaged employees return 120% of their salary
in value, partly engaged employees return 100%, somewhat
disengaged employees return 80% and disengaged employ-
ees return 60%.12
The 2014 Deloitte Global Human Capital Trends report
found that 87% of business leaders rate retention and
employee engagement as urgent or important, and employee
experience represents the biggest opportunity for HR today.13
See the sidebar, “Signs of Engagement,” for the characteris-
tics of engaged employees.
What does quality have to do with it?
When Gallup researchers compared teams in the top quar-
tile to those in the bottom quartile on the measurement of
engagement, they found median differences in performance,
as reflected in the bar chart in Online Figure 1, which can be
found on this article's webpage at qualityprogress.com.14
Combining these performance metrics into an overall
composite performance metric, teams in the 99th percentile
had four times the odds of success (or above-average perfor-
mance) compared with those in the first percentile.
Though team performance isn’t perfectly predictable,
these results provide strong evidence that it is possible to
measure the cultural elements of a team that predict how
well that team will perform. In other words, team culture
is, indeed, “stat-able.” Businesses that measure and manage
those elements can increase performance and improve their
chances of success.
Engagement has accelerated the most over the past
decade, with a seven-point improvement in the percentage
of engaged employees and a five-point drop in actively dis-
engaged employees. This represents about 10 million more
people with engaging jobs over the past decade.15 A truly
engaged employee is a truly committed employee. However,
investing in a superlative employee experience requires
discipline and hard work, and it takes time to fructify.

FIGURE 1

Maslow’s hierarchy of employee engagement

On average, less than

1 HIGHLY ENGAGED 15% reach this level. HIGH FLYER

• What can I do for others? • I love working here. SELF-

ACTUALIZATION
• I inspire others to do their best. • I'm a high flyer. 2 and 3 have a
direct impact and
can be moved up
2 ENGAGED by the 4 enablers
IMPORTANCE of engagement
• I'm a vital part of the business. • I'm an achiever.
• I feel important at work. • I'm really busy and likely stressed.

3 ALMOST ENGAGED
• I might leave if I'm tempted. MOTIVATIONS
• I know I'm part of something bigger. • There are no career
BELONGING
• I'm proud to work here. development opportunities.

4 NOT ENGAGED

• I'm not interested in overtime. • I don't like my job much. SECURITY

• I take more sick days than I should. • I read job ads.

5 DISENGAGED

• I'm here for the money. • I'm a clock watcher. SURVIVAL

• I am leaving when I can. • I'm a jobs-worth.

Source: “Employee Engagement,” SlideModel, https://slidemodel.com/?s=employee+engagement

20 || QP || June 2021

FIGURE 2
Employee engagement
Service
Employee Customer
engagement satisfaction
Retention
Source: www.forbes.com
Long before employee engagement became a trend,
American statistician and business philosopher W. Edwards
Deming formulated the 14 principles of effective man-
agement. Deming’s principles laid the foundation for the
modern total quality management (TQM). The 14 points first
appeared in Deming’s 1986 book, Out of the Crisis.16 A closer
look at these 14 principles reveals that many are linked to
improving employee engagement. The principles are foun-
dational to a robust quality culture and are highly dependent
on employee engagement.
ISO 9001—from the 2000 revision onward—is based on
seven principles, one of which is people engagement. Creat-
ing value occurs when people in the organization feel engaged
and understand how they contribute to creating and deliver-
ing value.
In addition, the newly released ISO 10018:2020 Quality
management—Guidance for people engagement provides
guidelines on how an organization might build, develop,
cultivate and nurture the kind of culture that gives strength
to the roots of people engagement.17 When people engage-
ment is nurtured, it feeds further development of an
organization’s quality culture.
Why is culture so important?
According to Dwayne W. Lehman, “Culture is an important
aspect of any institution and yet, it is difficult to find a single,
unified definition of culture.” 18 Organizations start with
individuals wanting to achieve a common goal, followed by
establishing artifacts (roles and rules), and creating norms
and values among members.19
Among the three levels of organizational culture—namely
artifacts, espoused beliefs and values—and basic underly-
ing assumptions, the latter is an invisible dimension of the
organization not easily expressed in concrete ways.20 These
invisible and visible elements of an organization are shaped
by the organization’s culture.21 A strong culture is manifested
EMPLOYEE ENGAGEMENT
Growth
Customer
loyalty
Profit
Productivity
by common values and norms (positive culture) with
a high degree of consensus among organizational members
(cohesive culture).22
Many authors consider TQM to be the ideal way to manage
quality in organizations.23-25 According to a research article on
TQM and organizational culture, quality management “should
be studied as a cultural phenomenon with a coherent set of
underlying assumptions that form an ideal quality culture.”26
This research also suggests that quality managers must under-
stand the existing organizational culture and bridge any gaps
for it to be compatible with quality culture.
Gil Luria presented the psychological explanation for
employees’ behaviors toward quality and the importance of
leadership in managing those behaviors.27 Transformational
leadership—that is, the actions of leaders who raise the needs
and motivations of followers, and promote dramatic change
in individuals, groups and organizations—is important in
the journey toward a strong quality culture.28, 29
Survey-based research to understand the obstacles to
TQM success found the second most significant barrier was
“inadequate human resources development and management.”
Elements of this particular barrier include:30
– Employees aren’t trained in quality improvement skills.
– Employees, teams or both aren’t recognized
for quality improvement achievements.
– Employees aren’t trained in prob-
lem identification techniques.
– Employees aren’t trained in group discus-
sion and communication techniques.
– Employees aren’t empowered to imple-
ment quality improvement efforts.
– Cross-functional teams aren’t employed.
On the other hand, other research revealed that
empowerment and contingent reward, charisma
and intellectual stimulation are important factors
for successful implementation.31
qualityprogress.com || QP || 21
 EMPLOYEE ENGAGEMENT

FIGURE 3

U.S. employee engagement trend (annual averages): 2019

% Engaged % Actively disengaged

34 35
32 33
30 30 30
28 28
26 26

20
18 17 18 18 17
16 15 14 13 13

'00 '01 '02 '03 '04 '05 '06 '07 '08 '09 '10 '11 '12 '13 '14 '15 '16 '17 '18 '19

Note: 2018 results are for January through June

Source: Jim Harter, “4 Factors Driving Record-High Employee Engagement in U.S.,” Gallup, Feb. 4, 2020,
www.gallup.com/workplace/284180/factors-driving-record-high-employee-engagement.aspx

22 || QP || June 2021
 EMPLOYEE ENGAGEMENT

TA B L E 1 In short, organizational culture forms

abstract and concrete aspects of organizations.

BEST principles Organizations are run by people with common

values and goals. Organizations with a positive
culture have a high degree of consensus among

–
–

Create an enabling culture at work.
Demand excellence.
their members and possess a strong culture.
A strong quality culture (that is, the quality
– Ugoals
nderstand the organization’s mission and strategic
as critical drivers of engagement. aspect of a strong organizational culture) is
–
–

Live the values—zero tolerance for violations.
Strive to be a leader in the domain.
built by transformational leaders who provide

– Don’t micromanage.
– L(theeadsingle
by example as a leader, not a manager. Walk the talk
the mechanisms for employee participation
and consultation, thus encouraging a highly
Business most effective employee engagement strategy
leaders have at their disposal). engaged workforce.
–
–

Overcommunicate—daily updates/huddles.
Keep every promise made.
Improving employee engagement
–
–

Make decisions based on data.
Make policies and processes lean and not restrictive. The following includes some practical ways to
– Share results. Employee engagement skyrockets when there is
a clear, positive correlation between employee action and the improve employee engagement. For the quality
organization’s success. aspect of the organizational culture to be sus-
– Parerovide clarity on goals at an individual level; ensure they
aligned to the business. Clarity is the first step to inspiring
tainable, there must be:
Senior management leadership and com-
ownership and commitment.
–
–

Remove obstacles to achieve goals.
Provide challenging assignments.
mitment. Senior management or the owner—​or
both—must show quality leadership and com-
Employee
– Create a hassle-free work environment.
– LDon’t
isten to employees and encourage frequent feedback. mitment by providing the necessary resources
let feedback drop off your radar. to manage quality in the organization. Quality
–
– Maintain job rotation and job enrichment programs.

–
Ensure trust and respect. leadership is shown by having a quality policy,
Have state of engagement meetings by group leaders
and supervisors.
leading by example, following the quality policy
– Focus more on soft skills, attitude and culture fit during hiring. and fostering a no-blame environment.
Moreover, commitment is manifested by
–
–

Provide an open work environment.
Provide collaborative platforms. monitoring quality key performance indicators
– Use public displays of appreciation freely and often.
As Mother Teresa said, “There is more hunger for love
(KPI), budgeting for quality training, establish-
and appreciation in this world than for bread.”1 ing mechanisms for employee participation and
–
– Encourage creativity. consultation, and implementing a suitable QMS.
–
Provide tools for efficiency and productivity.
Provide opportunities to bond after work hours,
such as at a social club.
Employee participation and consulta-
tion. Employees performing the task know the
–
–

Hold an annual awards night.
Offer work-life balance activities, flexible work hours essence of quality problem risk reduction and
Support and wellness programs. continual quality improvement. It is good prac-
–
– Share success stories.

–
Encourage open sharing of bad news, such as employee complaints. tice to involve employees when:
Have an ombudsman employees believe and respect, and can go to
for any issue. – Reviewing quality policies and procedures,
– Measure the employee pulse every quarter to maintain and sustain
employee engagement through tools such as ask.com, about.com,
particularly when formulating work instruc-
tions and standard operating procedures.
jivesoftware.com, cultureamp.com, qualtrics.com, kainexus.com,
meetoo.io, successfactors.com, ultimatesoftware.com, w, 6Q, etc.
Use technology to connect and measure.
– Establishing quality targets and action
plans to attain them.
– Support frameworks for giving back to society and corporate social
responsibility activities. Sponsor a charitable event. – Discussing quality problems and action plans
to correct and prevent them from recurring.
– Oandffercareer
continuous training and upskilling per business needs
development. (Good companies’ full-time employees – Formulating plans to improve overall prod-
receive 110 hours of training per year per person). uct and service quality.
Training –
–
Establish a formal mentoring or buddy program for all new hires.
Ddaysevelop an effective induction program. Make employees’ first
Quality management system (QMS)
memorable. implementation. QMS implementation must
– Build a knowledge repository or how-to guide. be suitable to the organization’s operation.
Dimitri Otis via Getty Images

It goes beyond having documented informa-

tion, such as a quality policy, procedures and
BEST = business, employee, support, training instructions. The system is a management
REFERENCE tool for lowering the risk of quality issues,
1. Mother Teresa, Quotable Quote, https://tinyurl.com/mother-teresa-love-quote. communicating quality requirements and

qualityprogress.com || QP || 23
 EMPLOYEE ENGAGEMENT
IoE Report: Leadership Is Key
Employee engagement is crucial to an organization’s
success—that’s why it’s so important for organizations
to invest in their workforces. When employees are happy,
they are engaged and emotionally connected to their work,
which improves product and service quality, and builds a
sustainable quality culture.
According to the authors of “You Get What You Give,”
employee engagement is leadership’s responsibility: “The best
organizations build and sustain a culture of engagement,
led by CEOs who understand that employee engagement is
not just nice to have, but critical to achieving business results.”
Last year, Forbes Insights, in partnership with ASQExcel-
lence (ASQE) and ASQ, examined how quality initiatives are
progressing in the digital era, based on the views and experi-
ences of 1,036 executives and quality professionals from global
enterprises. The results from ASQE’s Insights on Excellence
(IoE) Benchmarking Data allow ASQE to bring real-world
metrics and quality insights to ASQE and ASQ members.
performance, and enhancing quality KPI performance.
It should apply consistently with its purpose, and reflect
the organization’s activities and practices. Everyone in
the organization must know the system’s requirements,
and conformance to requirements must be monitored
regularly. New client and regulatory requirements,
and advancements in technology and quality improvement
plans must be reflected in the QMS, and everyone must be
notified of the changes. Also follow the business, employee,
support and training principles laid out in Table 1 (p. 23).
LEVERAGE LEAN
Although typically associated with manufacturing,
lean also can help improve culture and engagement
in organizations. Learn how eliminating waste and
nonvalue-​adding activities can improve employee
engagement—and the organization’s bottom line—
in the ASQTV episode, “Leveraging Lean to Improve
Engagement and Culture.” See the episode at videos.
asq.org/leveraging-lean-to-improve-engagement-
and-culture.
24 || QP || June 2021
To deliver actionable guidance to our member communities
to pursue best practices in organizational excellence and oper-
ations, the IoE 2020 Annual Research Report gathered data
on current leadership practices that may be surprising to some:
eight in 10 respondents indicated their leaders are on board
with quality to some degree, but this commitment does not
run deep. Only four in 10 said their leaders are fully open to
change and dialogue on quality engagements.
Considering the past year's challenges, the need for
guidance within this constant quality journey is even more
paramount. The IoE foundational data set provides members
with real-world insights on this topic and acts as a maturity
model of performance levels to inspire the advancement
of organizational excellence best practices.
Visit https://insightsonexcellence.org to learn more about
the ASQE Insights on Excellence and view the 2020 IoE Annual
Research Report.
The key to a culture of quality
People are your most important asset. If you take care of
your employees, they will take care of your business. Engaged
employees are the most effective evangelists and ambassa-
dors of your brand.32 Employee engagement is key to a strong
sustainable culture of quality. Nurture employee engagement
in whatever way you can. That will never fail.  QP
EDITOR’S NOTE
References listed in this article can be found on the article’s webpage
at qualityprogress.com.
Santosh Mishra is a quality leader at Saab Technologies
Ltd. in Burnaby, British Columbia. He received a master’s
degree in electronics and telecommunication from Pune
University in India. A senior member of ASQ, Mishra is
an active member and past chair of the ASQ Vancouver
Section and is a certified Black Belt.
Dennis Delgado is an occupational health and safety
professional at Athabasca University in Edmonton,
Alberta. He received an MBA from the University of the
Philippines Diliman in Quezon City. A senior member of
ASQ, Delgado is the treasurer, past chair and past vice
chair of the ASQ Vancouver Section. He also is an ASQ-certified manager
of quality/organizational excellence.
How Can You Achieve
Excellence in Quality?
It all starts with MasterControl Quality Excellence™ —
the most complete and connected quality
management system on the market today.

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 CHANGE MANAGEMENT

FE A R

MirageC via Getty Images

Managing employee resistance to change initiatives 

by Santosh Mishra and Natella Isazada

26 || QP || June 2021
 CHANGE MANAGEMENT

JUST THE FACTS

In today’s world of
volatility, uncertainly,
complexity and
ambiguity, change
is inevitable. But
many change
initiatives are met
with employee resis-
tance. The more
comfortable and
invested employees
are in the current
state, the more likely
they are to resist
anything that may
change that.
Resistance can’t be
eliminated, but it

OF THE
can be reduced with

U NK
the right approach.
The authors address
the key component
of successful change
management, and

N
provide tips and
advice for better
managing resistance
to change.
OW
N

qualityprogress.com || QP || 27
 CHANGE MANAGEMENT
C “People are not stressed because there is too much change
in organizations but because of the way change is made.”
hange management (CM)
has been the talk around
boardrooms for more than
two decades. In today’s world of volatility, uncertainly,
complexity and ambiguity, change is inevitable; it’s our new
normal. Table 1 (p. 30) summarizes the top forces stimulating
organizational change.2
According to a PricewaterhouseCoopers survey, 76% of
CEOs said their ability to adapt to new changes will be a key
source of competitive advantage in the future. 3 Change is
something that can't be wished away, yet there is no perfect
way to introduce and manage change. It also is reported that
70% of CM projects are unsuccessful.4 There are many vari-
ables and moving parts, and unless all are aligned, success is
unlikely. This trend will continue if we keep focusing on the
symptoms of the problem rather than the root cause.
One of the strongest human emotions is fear, and the old-
est and strongest kind of fear is fear of the unknown. Change,
by definition, brings with it many unknowns. So, we must
look more closely at the human fear of uncertainty and find
ways to address it.
One study reported that 39% of change failures are due to
employee resistance to change.5 Human behavior in organi-
zations does not work the way many executives think it does.
So, seeing change as an oversimplified version of Kurt Lew-
in’s well-known unfreeze-change-refreeze model, shown in
Figure 1 (p. 31), doesn’t consider that change is not always a
rational process. It’s true that firm before-change and after-
change points exist, but everything in between is nonlinear.
So, how can we explain resistance?
This article addresses what we see as the key component
of successful CM, namely managing resistance. We focus on
practical aspects based on our experiences, and provide tips
and advice on better managing resistance to change.
Is it psychological or physiological?
Research on brain function shows that resistance is not only
a psychological reaction to change, but also a physiological
reaction. We must understand the physiological connection
to appreciate why we resist.
Located above the orbitofrontal cortex—the eyes—where
error signals are generated, there is a small organ called the
28 || QP || June 2021
—Peter Drucker1
amygdala, which controls the brain’s fear circuitry. Error
detection signals can push people to become emotional and
act more impulsively. Animal instinct takes over. Trying to
change a routine behavior causes the brain to send a strong
message that something is not right. This message grabs the
individual’s attention and can overpower rational thought.6
Anatomy of resistance
Resistance originates from fear, prejudice, anxiety and
ignorance. People fear the unknown and are comforted by
the familiar. The more comfortable and invested employees
are in the current state, the more likely they are to ignore
or sabotage the reasons for change.
When people resist change, they resist the prospect of
losing what they have and hold dear—whether it’s losing
the control they currently hold, their comfort zone, their
job security or opportunities. They may fear an increased
workload with unrealistic new demands and tight timelines.
It does not help if past failures cause employees to distrust
the champion of the current initiative.
To better understand the anatomy, the entire process
is laid out in Online Figure 1, which can be found on this
article's webpage at qualityprogress.com.
Change is a process, not an event. Time will elongate if it
is not managed properly, and the process may never reach
the upslope predicted in Online Figure 1. Resistance can-
not be brought to zero, no matter how hard you try, but it
can be reduced with the right approach. Discussed later
are suggested practices based on our experience in leading
change initiatives.
Emotional baggage
People experience change on an individual level well before
they begin seeing it at an organizational level. Sometimes,
the fear of the unknown makes people cling to the old meth-
ods without questioning their effectiveness, efficiency
or even adequacy.
Overtaken by anxiety, employees are quick to resist the
change without giving it a chance or fully understanding
the benefits it offers. This often originates from a lack of
clear communication around the subject. Lack of leadership
communication on the vision and strategy leaves room for
 CHANGE MANAGEMENT

rumors, which in turn Middle

feed into people’s neg- Building a culture of management
ative emotions toward holds the key
the change. This espe-
open communication and Middle managers
cially affects people employee engagement are pivotal to any
who bring into the is an important piece of change initiative,
workplace heavy bag- the puzzle, and is highly and therefore,
gage of past failures and they require spe-
unresolved resentment.
correlated to the success cial attention. For
For example, we once of the change initiative. middle managers,
had a manufacturing change is neither
employee who saw any sought after nor wel-
change as an immediate come. It is disruptive
threat to his job. You may and intrusive, and upsets
call it an overreaction, but with the balance.
any change to company processes, Though often unwritten,
written procedures, equipment or the psychological dimension
technology, he suspected there would be underpins a manager’s personal
personnel cuts and that he would be the first commitment to individual and organiza-
one out the door. tional objectives. This gives a different message
A change to the company’s job traveler process threw him to their subordinates who take the cue readily.
off completely. He panicked and started a series of rumors— As helpful as it would be to have middle managers on
and backed up those rumors with vivid stories of disregard board with promoting the change to the rest of the team,
and mistreatment he had just experienced at his previous job, the amount of work they already have on their plates cannot
which was going through a similar change. be underestimated. They must manage daily operations
Only through numerous discussions and coaching ses- and allocate resources to ensure the timely progress of all
sions did it become clear that the damaging experience this existing projects and uninterrupted workflow throughout
person kept referring to had taken place at least 15 years ear- the organization. The change initiative creates extra work
lier. But to him, those memories were still fresh. This person for them, and they must manage it without any additional
relived the effects of his past trauma every time a change in resources. Is this extra workload manageable, or is it putting
the workplace triggered him. It took a lot of effort to help unreasonable strain on middle management?
him get over his fears and anxieties about change. If nothing comes off their workload, middle managers
It requires a lot of work and dedication from leaders to may still say yes to the executives, but when they flounder,
understand what’s behind the resistance, especially when the consequence eventually will show. If they cannot resist
it emanates from past experiences. Speaking about those openly, there always will be a risk of stalling progress in
experiences helps. other ways. For a while, there could be a false impression
Steve Zaffron and Dave Logan, authors of The Three Laws of things going well—and senior executives will believe it.
of Performance, point out that people are constrained by But in reality, things will not be moving in the right direction
what they aren’t saying. When they can address and articu- to realize the intended benefits of the change.
late what has been holding them back, space begins to open.7 Resistance to change from mid-level managers directly
A change in organizational culture is paramount to contributes to employee resistance. When workers see their
creating a safe space to discuss the underlying issues behind managers give a half-hearted effort to the change, they will
resistance. Building a culture of open communication and have a hard time taking the change seriously. Commitment
employee engagement is an important piece of the puzzle, from management must come first because managers are
and is highly correlated to the success of the change initia- directly responsible for implementing the change. All stake-
tive. Cultural change must involve and engage all layers of holders of affected processes must demonstrate that the
the organization because they each carry an important role proposed change is beneficial and, at a bare minimum,
in ensuring the change initiative succeeds. not harmful to the business.

qualityprogress.com || QP || 29
 CHANGE MANAGEMENT

System approach IMPROVE ENGAGEMENT Exercising a system approach

Because effects of the change thoroughly analyzes what and
may spread inside and outside For more on improving employee engagement, who will be affected by the
the organization, any new check out the ASQ webcast “Lean Tools to change, and how. What are the
initiative must be reviewed Improve Employee Engagement.” Lonnie Wilson, repercussions of the change on
from the perspective of con- a lean manufacturing and cultural transforma- other processes? This includes
straints it may impose on the tion expert, presents a mini-workshop on how direct and indirect processes,
to leverage lean tools and the catchall method
organization or its parts. This as well as those spreading
to substantially improve strategic deployment.
also includes constraints due beyond the boundaries of the
Watch the webcast at https://tinyurl.com/
to existing agreements, such employee-engagement-webcast. organization. What are some
as union contracts, vendor of the potential conflicts
contracts and commitments with the existing priorities?
to existing policies. The easiest way to adopt this
A system is a set of interconnected parts forming a complex approach is by reviewing change from the perspective of
whole. It’s also a set of detailed methods, procedures and rou- resource allocation. Start by asking yourself: Are there any
tines created to perform a specific activity or resolve a specific parallel projects that will be affected by or have an effect on
issue. An organization is a system relating to other systems, the change I am managing? Will we have to pull resources
contained within its industry and society. Any proposed from those projects to accommodate the change? Pulling
change usually is aimed at changing a business process to resources and forcing people to stretch thin is a definite
increase value for the business and its customers. A change way to fuel resistance.
in any one process has complex consequences for various The initial changes usually bring the most tangible results.
parts of the system. After the most apparent problems are solved, further changes
will be incremental, resulting in less visible benefits. With this,
TA B L E 1
you may start paying less attention to the possible implications
of the changes in other areas. But you must follow through

Six forces for stimulating

with the systems approach until the end to remain aware of
any potential bottlenecks.

organizational change Tips and advice for managing resistance

For the change to become a permanent part of the corporate
culture, resistance must be controlled by accounting for
all factors that contribute to it. Unless people rally behind
Force Examples the change and feel the desire to support it, results will be

Nature of the – Aging

More culture diversity half-hearted. Change only happens if you can create that

workforce – Increased
population conviction and desire. That is where you should focus your
– immigration and outsourcing efforts—explaining the burning platform behind the change.
– computers
Faster, cheaper and more mobile
and handheld devices
To overcome their indecision and confusion, people need
a clear destination. Create that crystal-clear picture of the
Technology – Emergence and growth of social
media networking sites
desired future state so your valuable time and resources

– Deciphering of the human genomic code aren’t wasted.

– Rise and fall of global housing market
Economic shocks – Global recession
Financial sector collapse
– mation. Don’t assume that all the right people will somehow
– Global competitors
Competition – Increased
Mergers and consolidations
– government regulation of commerce
– Increased environmental awareness
Social trends – Liberalization of attitudes toward gay,
lesbian and transgender people
– More multitasking and connectivity
– Rising healthcare costs
If the change initiative fails because of communication
breakdown, develop a strategy for communicating key infor-
find out everything they must know regarding the change.
If you don’t manage the communication channels prop-
erly, people will rely on the grapevine for information.
Over-communicating the vision always is preferred to
under-communicating.
People often resist because they are more focused on what
they might lose as a result of the change. It’s the job of leaders

World politics – Negative social attitudes toward

business and executives
to reorient the focus and show people what can be gained
instead. Bumps in the road are expected, but here are some
– Opening of markets in China helpful tips to effectively manage the change:

30 || QP || June 2021

FIGURE 1
Kurt Lewin’s change management model
Unfreeze Change
– Engage the right resistance managers, sponsors
and champions. Increase their awareness skills
(58% of sponsors do not understand their roles8).
– Engage middle managers in particular. Demonstrate
your commitment to the change by removing barriers
and providing resources.
– Focus on identifying, creating
and rewarding new desired behaviors.
– Ensure constant feedback from resistors;
create that framework and safe space.
– Share success. Over-communicate
the vision and small wins.
– Explain why (the business need) repeatedly, including
the consequences of maintaining the current state.
– Invest time and effort on desire. The awareness, desire,
knowledge, ability and reinforcement model/sequence
is important.9
– Provide simple, clear choices and consequences
so ownership shifts to the individual.
– Try to convert the strongest dissenters, but do not focus
time and energy on only them because the outcome is
limited. Instead, focus on those who are enthusiastic
about the change and see value in the change.
– Keep up hope and a positive spirit, and make
a personal appeal.
Managing success
Change can be difficult, hard and arduous, nonlinear and
unpredictable. In practice, it is far from the unfreeze-
change-refreeze process. Resistance to change is a normal,
human, physiological reaction that is to be expected. About
70% of change initiatives fail. One of the key contributors to
failure is the half-hearted acceptance of middle managers
and close to no involvement from top management.
But all is not lost—this reality can be reversed. With some of
the tips provided, change initiatives can be managed to succeed.
CHANGE MANAGEMENT
Refreeze
According to research from Prosci, senior management partici-
pation and involvement have been consistently at the top of the
success criteria for the past 20 years.10
The top three aspects that make any change initiative
a success are:
1. Management explaining the “why” behind the change
and outlining the consequences of not taking action
toward the change effort.
2. Focusing on one change at a time and creating that desire.
Change happens at individual levels only.
3. Treating all change initiatives like a formal project,
with continuous communication and sustenance in mind.
With even a single successful project under your belt,
you can navigate other changes with fewer impediments.  QP
EDITOR’S NOTE
References contained in this article can be found on the article’s webpage
at qualityprogress.com.
Santosh Mishra is a quality leader at Saab Technologies
Ltd. in Burnaby, British Columbia. He received a master’s
degree in electronics and telecommunication from Pune
University in India. A senior member of ASQ, Mishra is
an active member and past chair of the ASQ Vancouver
Section, and is an ASQ-certified Black Belt.
Natella Isazada is an environmental, health and safety
manager at Treehouse Foods in Delta, British Columbia.
She received a master’s degree in public administration
from the University of Nebraska Omaha. A senior
member of ASQ, Isazada is chair of the ASQ Vancouver section, an ASQ-certified
manager of quality/organizational excellence and a trained ISO 9000 lead auditor.
She is the author of Quality 4.0: Are You Prepared? (2018).
qualityprogress.com || QP || 31
 O RG A N IZ ATI O N A L S T R AT EGY

32 || QP || June 2021
 O RG A N IZ ATI O N A L S T R AT EGY

JUST THE FACTS

When developing
strategic plans,
organizations must
look well beyond the
next three to five
years. At the same
time, organizations
must be able to
pivot and evolve
their strategic
plans in real time
(within reason) to
remain viable.
Enterprise Strategic planning
strategic must be methodical,
planning for well thought out,
inclusive of the
the 2020s and right stakeholders
beyond requires and aligned with
a heavy dose of customer expecta-
tions. There’s a basic
transformation  four-step process
by Casey Bedgood to begin strategic
planning.
An important
element to
this planning is
organizational
culture. Strategy
is just a theory
unless interwoven
into organizational
culture. Long-term
organizational
change will only be
achieved through
culture transfor-
mation, which is
predicated on vision,
mission, values
and trust.

qualityprogress.com || QP || 33
A
O RG A N IZ ATI O N A L S T R AT EGY
s strategists consider strategic
planning options for the 2020s and
beyond, the million-dollar question
becomes, “What are the ideal focus
areas?” Will strategies of the past
work in the new decade? Or is a
new prescription needed?
The market is constantly
evolving, and new horizons will
require innovative strategies to
ensure organizations can com-
pete, remain viable and grow
their footprints as the evolution
continues. All good strategies
begin with a reflection of
where the market has been,
where it is currently and
where it is projected to pivot.
One common misstep for organizations is to focus
solely on improving the current state of operations during
a three to five-year period. The new world, particularly in
healthcare, will require improvement plus a heavy dose
of transformation. Subsequently, a new strategic prescrip-
tion—laden with innovative ideas, speed to execution and
customer-centric foci—is needed to help organizations plan
for the road ahead beyond the next three to five years.
In healthcare, for example, there have been several stra-
tegic pivots in the past decade or so that have reshaped the
operating landscape. For years, healthcare organizations
were focused on outperforming local competitors. The main
strategy was to magnify brand loyalty by providing the high-
est quality services in the local community. This was mainly
a bricks-and-mortar strategy in which enterprises succeeded
by meeting operational goals tied to cost, service and quality.
If hospitals could outpace the local competition, customer
word of mouth all but ensured their market dominance for
years to come.
In recent years, however, the market shifted from a local
to a regional focus. Depending on the organizational foot-
print, regional could mean a state or country. Moreover, the
healthcare market leaped toward high performance in which
newly emerging regional competition required enterprises
to meet and exceed goals tied to service, cost and quality.
Thus, there was a massive influx of process improvement
methods and experts into the healthcare industry. Many
organizations began training lean Green Belts or Six Sigma
Black Belts as internal consultants to reduce and elimi-
nate process-related waste. Improvement strategies were
34 || QP || June 2021
centered on reducing costs, improving service and magnify-
ing customer satisfaction.
Some organizations created continuous improvement func-
tions that focused on cyclical process improvement initiatives
centered mainly on incremental improvements. The good
news is that incremental process improvement can produce
great return. But the downside is these mechanisms take time
to realize those returns.
While many organizations were focused on creating
regional improvement roadmaps for their high-performance
journeys, the market shifted again with a renewed customer
focus on innovative thinking and disruptive activities. This
new market paradigm shifted focus away from regional oper-
ations to the national healthcare stage. Moreover, the new
market required fast-paced transformational change instead
of incremental improvements. This shift also placed custom-
ers into the driver’s seat, where all facets of healthcare must
be customer-centered.
Masters of excellence
In this market environment, healthcare organizations
are required to master five elements of excellence: service,
cost, quality, people and value. Service, cost and quality are
self-explanatory and common across all industries. The peo-
ple factor relates to initiatives such as workforce engagement,
turnover and employee satisfaction. The general industry
consensus is that higher levels of workforce engagement
and satisfaction are correlated with higher levels of orga­
nizational performance.
Value is the new norm in which many organizations are
struggling to crack the code.1 Simply stated, value is anything
related to accuracy and timeliness. Customers are unwilling
to pay for or tolerate delays or errors in the current health-
care setting. In addition, revenue sources for healthcare
are quickly becoming dependent on value and organiza-
tions’ abilities to meet and exceed customer expectations.
Hospitals are being financially incentivized to become
masters of excellence.
After high-performance health systems reach this new
threshold of excellence, the market now dictates they maintain
a continuous improvement culture. All facets of the orga-
nization’s fabric must be targeted for magnifying customer
satisfaction, creating innovative access points for customers
to receive care and realizing continued cost reductions.
iStock.com/francescoch
This new operating environment has spawned a renewed
interest for some enterprises to invest in talent, such as
strategy and innovation officers. Some health systems have
created internal innovation centers and hubs to traverse the

FIGURE 1
Strategic planning cycle
Fast track pulse check
1 2
Organizational
performance review
– Gap analysis
– Strengths, weaknesses,
opportunities and threats
– Improvement hot spots
– Organizational risk
assessment
4 3
– Measure results
– Control wins
new market expectations. In some instances, the innovation
hubs focus on merging continuous improvement, research and
new technologies.
The innovation models and success potential depend on
the organizational scope, resources and market. In retro-
spect, some of these models have succeeded while others
have failed. The real question is whether healthcare inno-
vation will be a fad or fashion. Fads tend to be short lived
and morph into a distant memory. On the contrary, fashions
evolve and retain a long-term market presence.
As the market is currently idling around excellence,
transformation and continuous daily improvement culture,
the next pivot is just around the corner. The market always
forecasts its next step. The next evolution point will be cen-
tered on price transparency, consumerism and fee-for-value.
These have been extremely hot topics as of late on the national
stage and momentum is gaining.
In layman’s terms, this means that hospitals and health
systems must be the high-quality, low-cost provider of health
services when compared to other enterprises across the country.
Also, these institutions must be more transparent with their
costs by making this information readily available to consumers.
Anything else will be unacceptable to customers.
O RG A N IZ ATI O N A L S T R AT EGY
Roadmap planning
– Regulatory requirements
– Market forces
– Vision, mission and values
– Three-year plan
– Goals and objectives
Implementation
– Roadmap
– What, who and when
The result will be organizational disruption because the
traditional local and regional focuses are no longer relevant.
The only question is, “How many healthcare enterprises will
be able to pivot and survive?”
The road forward (strategic process)
By definition, a strategy is “a careful plan or method for
achieving a particular goal usually over a long period of
time.”2 All organizations should consider long and short-term
strategies. Common strategic focus areas historically have
included topics such as revenue growth, cost containment
and transforming the quality of services provided. In many
organizations, traditional strategic planning initiatives occur
annually, and effectiveness tends to be measured at year’s
end each year.
Will strategies of the past work in the new decade?
The most prevalent answer is, “Probably not.” What needs
to change? Essentially, everything related to the process,
focal points and frequency of strategic planning. A simple
four-step basic strategic planning process is a good start-
ing point.
Step one: Assess the organization and current market
space. This step answers, “Where are we now?” Focal points
qualityprogress.com || QP || 35
 O RG A N IZ ATI O N A L S T R AT EGY
FIGURE 2
Strategic planning focus areas
Operations Talent Regulatory
must center on the organization’s financial performance
(that is, costs and revenues), internal strengths and weak-
nesses, along with external opportunities and threats.
The assessment also should include a deep-dive root cause
analysis for weaknesses, opportunities and threats. Leaders
must view the assessment with the customer at the center of
the process. What does the customer require now and will
it potentially require soon? Market data and projections are
vital to making accurate current and future-state predictions.
Next, the enterprise should focus on the roadmap
planning stage. This stage answers, “Where do we need to
go?” Leaders must review vision, mission and values during
this phase. Vision is simply where the organization must go
compared to where it is. The mission answers, “Why are
we here?” Values represent the cultural expectations of the
organization. Does the vision statement and culture of the
organization align with the current and future market direc-
tion? If not, recharter the course quickly
by updating vision and values.
Step two: Leaders should craft the
three-year operating plan for the
organization related to technology,
talent, finances and improvement
goals for the enterprise at min-
imum. The three-year plan
must be pliable and nimble
because the market likely
will change annually,
if not more frequently.
It’s imperative to note
again that the three-year
plan must align with the
future direction of the market.
If not, the organization will sail
in the wrong direction.
After the vision and direction
are decided, tactical goals and objec-
tives should be solidified. The goals and
36 || QP || June 2021
objectives must be aligned directly to the vision and multiyear
organizational strategy. If not, the organization’s final desti-
nation will not coincide with the next market pivot.
Leaders must focus on micro, divisional and enterprise
goals during tactical planning. Enterprise goals alone will not
move the ship in the right direction. Frontline leaders and
staff must understand how their micro goals connect directly
to the organization’s vision and strategy. The divisional lead-
ers are the conduit that will ensure this process is effective.
If not, organizational culture will erode the strategic plan at
its core. Communication cascade is one of the most important
aspects of the planning stage.
Step three: Craft the implementation plan. This stage
answers the question, “How do we get there?” Implementation
should include tangible plans to activate the organizational
roadmap. This includes a simple what, who and when. In other
words, what is to be done, who owns it and when will it be done.
Progress should be tracked and any implementation items not
on track should be elevated to the senior leaders and board
for correction.
Step four: Measure and control. This answers the ques-
tion, “Did we make it?” to the ideal destination. In years past,
healthcare organizations, for example, implemented annual
strategic goals and measured the outcomes typically at year’s
end. In the new market environment, periodic pulse checks
should be conducted throughout the year. Frequency depends
on organizational scope, resources and analytics capabilities.
But the market is moving too quickly to wait until the year’s
end to assess how the organization is performing. An annual
pulse check may not prevent an organizational misstep as
market pivots occur.
Strategy focal points
The strategy process must ensure
the plan is aligned with customer
expectations and current market
requirements, and is agile enough
to pivot with future market
shifts. The basic recipe for
the new healthcare market
is to focus on operations,
people and regulatory
requirements during the
strategic planning process
(see Figure 2).
Operations is the traditional
focal point in which organiza-
tions primarily ensure revenues
iStock.com/francescoch
exceed costs. It’s a good idea to proj-
ect cost and revenue streams three to
five years out to ensure enough capital
will be available to fund strategy. Without

– Lack of organizational awareness. As it has been said,
“Ignorance is bliss.” Unfortunately, in today’s operating
environment, organizations cannot afford to be unaware
of the market’s current state and next projected pivot.
Lack of perspective as to organizational alignment with
current and future market requirements is detrimental.
Thought leaders must scan the horizon, think several
years ahead and measure organizational performance
frequently along the journey. Strategic pulse checks,
corrections and pivots are the new norm.
– Lack of communication. Communicate to executives,
divisional leaders, and frontline leaders and staff effectively
and regularly. Overcommunicate the organization’s mission,
vision, values and guiding objectives. Incorporate goals and
objectives into a performance-based incentive program.
Reward high performers and incentivize low performers to
change. Long-term organizational change will be achieved
only through culture transformation, which is predicated
on vision, mission, values and trust. Strategy is just a theory
unless interwoven into organizational culture. Goals will not
be attained if no one knows what they are.
– Bad strategic process. The strategic planning process
should include a minimum of four steps: assessment,
planning, implementation and measurement. After goals
are attained, control mechanisms must be in place to
prevent operational slippage. The process must be as
nimble as the market. If the market is pivoting every one
to two years or sooner, three-to-five-year strategic plans
may be irrelevant. Strategy leaders must understand the
current market state, its volatility and destination for the
next pivot with reasonable certainty. If not, the enterprise’s
aim will be off target. Strategic plans must be visionary
at the core, but moldable to the market shifts and rate
of change.
funding, strategy will remain an elusive theory with minimal
impact on organizational outcomes long term.
Another crucial piece of operational strategy focus is ser-
vice. In the healthcare industry, service essentially equates to
customer experience. In years past, the lingo was “customer
satisfaction,” which organizations measured how satisfied
customers were with the organization’s performance overall
during a service interaction.
Now, healthcare organizations have shifted to the tag line
of “customer experience,” which measures the service-level
O RG A N IZ ATI O N A L S T R AT EGY
– Excluding regulatory experts in strategic planning.
Strategy leaders must include all the relevant stakeholders
during the assessment and planning phases. Healthcare is
one of the most highly regulated industries, and regulations
tend to change often. A good example is a health system
that attains ISO 9001 certification, which requires the orga-
nization to have a continuous improvement method, tools
and outcomes. If continuous improvement is not included
in the strategic plan, the organization will not be compliant,
thus, jeopardizing its revenue stream and market relevance.
– Lack of understanding or focus on value. Regardless of
industry, all customers expect to receive value from each
transaction with any organization. Value is essentially any-
thing a customer is willing to pay for. If the organization is
laden with delays or errors, for example, the customer will
look elsewhere for that good or service. Value add is the
new norm and the minimum expectation for service indus-
tries, particularly healthcare. Organizations that add value
will thrive while those that don’t will shrivel on the vine.
– Focusing on the new shiny models, concepts and
technology. The basics must be in place for the shiny
to work. A good example is an organization that invests
in a new technology that the workforce does not under-
stand or support. Years ago, a healthcare system invested
in an internal social media platform. The leaders and staff
already used more than a dozen communication plat-
forms such as cell phones, work phones, pagers, e-mail,
external social media and many others. The internal
platform was seen as just another time zapper and was
not accepted or used by the leaders and staff. Thus,
the new technology was not worth the investment and
did not improve organizational performance or customer
satisfaction. Master the basics before leaping toward
new shiny objects. —C.B.
satisfaction each customer has with each touchpoint during
his or her service journey. A touchpoint is anywhere the cus-
tomer touches the organization and vice versa. This is a more
holistic approach to assessing, measuring and improving the
overall customer experience while providing service recovery
in as real time as possible.
The second and arguably most important strategic
focal point is people. Peter Drucker and other thought leaders
have alluded to the fact that “Culture eats strategy for break-
fast”3 or lunch. Thought leaders must consider the talent
qualityprogress.com || QP || 37
 O RG A N IZ ATI O N A L S T R AT EGY
pool currently available,
organizational culture
and learning when
crafting strategic plans.
As previously noted,
organizational culture
is the way work is done in
the enterprise. Is the culture
change-resistant? Or does the
culture accept change? Strate-
gists can create amazing plans that
ultimately will sink like a lead balloon
if culture is not aligned properly.
Another important aspect is the
current talent pool and learning strategy. It’s imperative
to know whether the organization’s talent pool is equipped
and aligned with the strategy. A good example includes the
adoption of new technology over a three-year period. If the
strategic plan includes tactics to implement the new tech-
nology in year one, the leaders must have talent skilled prior
to the implementation. If the talent pool needs two years of
training to upskill, the strategy will not be successful as
planned. Timing, talent and strategy execution are not mutu-
ally exclusive. In reality, they are intermingled and required
elements of successful strategic execution.
The final focal point of strategic planning is regulatory.
We have experienced this many times in healthcare organi-
zations in which regulatory experts are not included in the
strategic planning process. Subsequently, strategies must be
adjusted or reworked after the fact as regulatory require-
ments emerge. Thus, strategies become fractured and less
effective. Ultimately, operating plans instead of visionary
canvases transform the organization.
The main regulatory focal point should be risk. By defi-
nition, risk “is the possibility of loss or injury.”4 The new
lingo used in many progressive healthcare organizations is
risk-based thinking.5 Risk-based thinking requires enterprise
leaders and strategists to identify, control and improve risks
during organizational planning. The goal is to be proactive,
not reactive. The questions strategists should answer are:
“What are the risks if we don’t change?” and, “What are the
risks if we do change?” Mitigation plans for all risk types
should be included in the strategic canvas.
Casey Bedgood is the system accreditation optimization officer and Six Sigma Black Belt at Navicent Health in Macon, GA. He received
a master’s degree in public administration from Georgia College and State University in Milledgeville. Bedgood is an Institute of Industrial
and Systems Engineers-certified Lean Green Belt, Six Sigma Green Belt and Six Sigma Black Belt, and a member of the American College
of Healthcare Executives.
38 || QP || June 2021
Sample risks may include
turnover, succession
planning, transferring
knowledge throughout the
organization, implementing
new technologies, partner-
ships, emergency management
plans, capital funding and many
others. Don’t wait until the risk
becomes a reality. Reward leaders for
thinking outside the box and mitigat-
ing risks early. Leaders must understand
that risk to the organization is a risk for the
customer, and vice versa. All risks should be
controlled and mitigated before affecting the customer.
The new prescription
The new norm and only constant in today’s market is change.
As the market changes, so must organizational strategic plan-
ning processes. Strategic planning must be methodical, well
thought out, inclusive of the right stakeholders and aligned
with customer expectations.
The old prescription focused solely on improving organi-
zational performance over long periods no longer will suffice.
The new prescription must include a heavy dose of transfor-
mation where the organization’s future state will become
radically different quickly.
Moreover, as the market continues to pivot, organizations
must evolve their strategic plans in real time (within reason)
to remain viable. Ultimately, more does not always equate to
better. If an organization focuses on the new shiny innovative
foci when fundamentals, such as culture, process and struc-
ture, are missing, there is a good probability that the shiny
will become a distant memory sooner than later.  QP
REFERENCES
1. Atrium Health, “Redefining Value for Healthcare,” Institute of Industrial & Systems
Engineers, IM Magazine, April 2019.
2. Merriam-Webster, “Strategy,” www.merriam-webster.com/dictionary/strategy.
iStock.com/francescoch
3. Bertrand Ross, “Culture Eats Strategy for Breakfast,” Management
Centre, www.managementcentre.co.uk/culture-eats-strategy-for-breakfast.
4. Merriam-Webster, “Risk,” www.merriam-webster.com/dictionary/risk.
5. International Organization for Standardization (ISO), ISO 9001:2015—
Quality management systems—Requirements, www.iso.org/standard/62085.html.
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 C APA SYSTEM

JUST THE FACTS

Don’t overlook assessing the

effectiveness of your CAPA Corrective and Often, organizations The authors offer
system and your solutions  preventive action don’t thoroughly advice on evaluating
(CAPA) systems are evaluate the the system and
by José Rodríguez-Pérez and widely used in many effectiveness of the verifying the solu-
Manuel E. Peña-Rodríguez industries to assess CAPA plan, as well tions implemented
how a quality man- as the actions being are effective and
agement system is taken to eliminate working.
performing. the problems.

Jorg Greuel via Getty Images

40 || QP || June 2021
 C APA SYSTEM

qualityprogress.com || QP || 41
 C APA SYSTEM
M
ost organiza-
tions devote an
important part
of their resources
to dealing with
incidents, investigations, and corrective and preventive action
(CAPA) systems. Figure 1 shows the closed-loop CAPA system,
which consists of three phases: investigation, the CAPA plan
implementation and effectiveness evaluation.
The third phase—effectiveness evaluation—is a critical
part of the CAPA system, but unfortunately, this phase often
is overlooked. This article addresses that and presents many
common pitfalls you may encounter when using CAPAs,
as well as some best practices to help you make your next
CAPA system most effective.
A robust quality management system (QMS) must moni-
tor its processes continually to identify existing or potential
sources of nonconformities. Investigations are performed to
find the root causes of any nonconformities. Next, corrective
or preventive actions are identified and implemented. Finally,
it’s time to determine the effectiveness of the corrective
or preventive actions. Talking in terms of problems and
solutions, we must verify that the solutions actually work.
Two main elements here are how and when the verification
is accomplished.
Verifying the solutions worked
One of our favorite things to do at the beginning of a CAPA
training session is to ask participants what and how they
evaluate the effectiveness of implemented actions. Most
participants mention that an action is effective if the problem
does not recur. Rarely does someone define it correctly as the
lack of recurrence of the same root causes.
After we define what a corrective or preventive action is
(the action that addresses the root cause), everyone under-
stands that the effectiveness relates to the causes—not to
symptoms or problems. If similar symptoms are observed,
don’t jump to the conclusion that the action was ineffective.
To be able to conclude this, you must first identify the
root causes of this repeated symptom. If you reach the same
root cause, you can conclude that the previous action was
ineffective. If you discover that, this time, the problem
was the result of a different root cause—which is a common
situation—the effectiveness of your previous action is not
in question.
42 || QP || June 2021
Within the same line of reasoning, sometimes you inves-
tigate a new problem and discover the situation was created
by a root cause that you already fixed. In this case, you have
evidence that the previous corrective or preventive action
was ineffective.
Figure 2 (p. 45) shows the interrelationships between the
corrective or preventive actions, and the root cause(s) they
are addressing directly. It is always important to specify
which root cause(s) each corrective or preventive action is
addressing. Otherwise, you will have actions not linked to any
root cause(s) not addressed with any action.
There also are some misunderstandings related to verifying
the effectiveness of the actions implemented. Some organiza-
tions document that the action was implemented—not whether
the action worked. If the action is not implemented, it does not
have a chance to be effective. The implementation verification
is a different concept.
At this point in the CAPA cycle, the QMS requires evidence
that the implemented corrective or preventive action was
effective, and the intended objective was indeed accomplished.
Root causes are detected through the symptoms they
produce. Therefore, to determine whether a corrective
action was effective, analyze the process that root cause
acted upon. A typical question here is, “How long does it
take to verify the effectiveness of the actions?” Some orga-
nizations have a fixed period (three months, six months or
one year), while others take the correct approach by linking
that period to the frequency of the process being fixed.
A rule of thumb we recommend using is the “double-digit”
rule. It requires having at least 10 repetitions of the process
in which the corrective or preventive action was applied prior
to establishing whether the action was effective. If you use a
fixed period (for example, one month) and the process is per-
formed weekly, you have only four or five results (in the best
case) to determine such effectiveness.
Statistically, there is a large probability that those first four
or five repetitions are fine simply by chance—even though the
action did not work. By extending the evaluation to at least 10
repetitions, you increase the confidence level. With 10 good
results, you can be confident that the action worked.
The documentation of the effectiveness evaluation should
be generated along with the rest of the CAPA plan. After
documenting the implementation of the action, the only
remaining (open) task from the plan is the effectiveness
evaluation. The vast majority of CAPA effectiveness plans
are totally reactive. We always recommend establishing
Jorg Greuel via Getty Images
a verification method that proactively looks for measures
of effectiveness.
A typical situation is implementing a corrective action after
receiving several complaints on a product. In this scenario,
the action is considered effective if no complaints are received
 C APA SYSTEM

FIGURE 1

Closed-loop CAPA process

Existing or potential
nonconformity

Correction(s)
Investigation

(containment)

Investigation

No
Root cause?

Yes Product disposition

(correction)
CAPA plan

CAPA plan

Permanent
Permanent
Interim actions preventive action
corrective action
(if applicable)
Effectiveness evaluation

No Was
effective?

Yes

Close effectiveness
evaluation

CAPA = corrective and preventive action

qualityprogress.com || QP || 43
 C APA SYSTEM

during the next three months. READ MORE However, nothing is said about train-
Lack of complaints does not nec- ing effectiveness: Did they like the
essarily mean that the issue was training? Did they learn something?
For more details on CAPAs, see José
fixed because most complaints Are they using what was learned? Has
Rodríguez-Pérez’s Handbook of Inves-
are delayed by many weeks or the organization benefited from the
tigation and Effective CAPA Systems,
even many months. second edition, Quality Press, 2016. training efforts?
A more adequate way to Additional information about the book
determine the effectiveness can be found at asq.org/quality-press/ Common pitfall: lack of
of the corrective action is display-item?item=H1504. effectiveness evaluation of
monitoring the next five or 10 action taken
batches produced using an A corrective action is consid-
appropriate sampling plan. ered effective if it can avoid the
This statistically sound sampling plan can provide an ade- recurrence of the cause. Therefore, the evaluation of the
quate confidence level about the effectiveness of the action. effectiveness cannot be tied to the presence or absence of the
And yes, it is fine if you also include as a second element symptom because:
of this effectiveness verification some criterion regarding – The same symptom can be produced by different
a reduction in customer complaints associated with this root causes.
root cause. – The same root cause can create different symptoms.
There also are misunderstandings related to the verifica-
Training effectiveness tion of effectiveness. Some organizations document that the
Most corrective or preventive actions require some sort of action was implemented rather than provide evidence that
training or retraining. Measuring training effectiveness, how- the action worked as intended. From our experience, the two
ever, is not a task that many organizations perform. Training is major flaws in the effectiveness verification are:
a critical component in any organization’s strategy, but organi- 1. Actions are not clear enough.
zations rarely evaluate the impact of their training programs. 2. There’s a lack of adequate metrics.
The management of effective training provides the overall One way to analyze the effectiveness verification state-
structure needed to ensure that training programs have pro- ments during investigation and CAPA expert certification
cesses in place to support the operations. Organizations that is to determine whether those statements have these three
monitor training effectiveness and strive to improve weak- elements: actions, a timeframe and metrics.
nesses are consistently the best performers. It is important Examples of inadequate verification of effectiveness
to develop methods to measure, evaluate and continuously include: “The corrective action was implemented,” or,
improve training. “The problem did not appear during the past three months.”
Often, the training function is seen as an expenditure An example of an adequate verification of effectiveness is:
center rather than as one of the most critical activities in “During the next two months, a performance evaluation of 15
any organization, especially in highly regulated environ- associates (five from each shift, randomly selected) will be
ments in industries such as nuclear, aerospace, medical and performed to verify compliance with the procedure related
pharmaceutical. In these industries, training results must to the use of personal protective equipment. Corrective action
be measured. Incorporating selected training metrics into will be considered effective if all evaluated operators were
a reporting strategy can help demonstrate the real value of following the procedure.”
training. Measurements that consider performance improve- Note that this effectiveness verification statement has
ments can provide a benchmark for training effectiveness. actions (the performance evaluation), timeframe (two
An important consideration is that most of the corrective months) and metrics (all operators follow the procedure).
or preventive actions are related to some training efforts,
and therefore, the effectiveness of these training actions must Best practices
be evaluated. For most organizations, however, the only record When structuring your CAPA system, we strongly suggest
generated from training activities is simply the attendance clearly defining the evaluation of the effectiveness of the
sheet itself. corrective or preventive actions. Also establish statistically
Jorg Greuel via Getty Images

When evaluating the possible impact of training during
nonconformance investigations, these sheets merely deter-
mine whether the personnel involved in the failure signed
the corresponding training roster. If so, they conclude that
training can be discarded as a root cause of the situation.
sound verification plans, or at least use the double-digits rule
of thumb—that is, allow enough time to permit the evaluation
of at least 10 repetitions of the process under evaluation.
For a daily process, for instance, one month is a good
amount of time to establish effectiveness. If the process is

44 || QP || June 2021
 C APA SYSTEM

FIGURE 2

Interrelationships between CAPAs and root causes

Corrections
Corrective and/or
preventive actions
Causal Root
factor cause
Corrective and/or
preventive actions
Existing or
potential
nonconformance

Causal Root Corrective and/or

factor cause preventive actions

Corrections

CAPA = corrective and preventive action

WATCH OUT
performed about every week, three months should be enough.
If the process runs about every month, one year should be See a two-part webcast on the basics of
a reasonable period to determine whether the corrective root cause analysis, including corrective and
action was effective. preventive actions, with James J. Rooney,
Assessing the effectiveness of your CAPA system will an ASQ fellow and quality veteran with
ensure you get answers to your questions around nonconfor- more than 30 years of experience. To access
mances, and you’re able to make the appropriate adjustments the recording, visit https://videos.asq.org/
to your QMS in a timely manner.  QP keyword/preventive-action.

José Rodríguez-Pérez is president of Business Excellence Consulting Inc. in Guaynabo, Puerto Rico. He has a doctorate in biology from the
University of Granada in Spain. Rodríguez-Pérez is a senior member of ASQ and an ASQ-certified auditor, biomedical auditor, hazard analysis
and critical control points auditor, engineer, manager of quality/organizational excellence, pharmaceutical good manufacturing practices
professional and Six Sigma Black Belt. He is also the author of the best-selling books Handbook of Investigation and Effective CAPA Systems,
second edition, Quality Risk Management in the FDA-Regulated Industry, second edition, The FDA and Worldwide Current Good Manufacturing
Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals, and Human Error Reduction in Manufacturing, all available from Quality Press.

Manuel E. Peña-Rodríguez is a consultant at Business Excellence Consulting Inc. He earned a Juris Doctor from Pontifical Catholic University
in Ponce, Puerto Rico, and a master’s degree in engineering management from Cornell University in Ithaca, NY. Peña-Rodríguez is a senior
member of ASQ and an ASQ-certified quality engineer, auditor, manager of quality/organizational excellence, Six Sigma Black Belt, biomedical
auditor, and hazard analysis and critical control points auditor. He also is the author of the books Statistical Process Control for the FDA-Regulated
Industry and Process Monitoring and Improvement Handbook, second edition, both available from Quality Press.

qualityprogress.com || QP || 45
THE DOWNLOAD
DATA Q UA L IT Y
The Cornerstone
Of 4.0 When leveraging digital systems to improve quality,
data quality directly affects quality of outcomes
by Nicole Radziwill
n January, I preregistered for
I
my COVID-19 vaccination
appointment. A chronic med-
ical condition since childhood
puts me at a higher risk of com-
plications, so I was jubilant when the
email finally arrived with a link to sign
up for my time slot. (I’m glad it wasn’t a
phishing email because I clicked on that
link with lightning speed.)
But there was a problem: There
weren’t actually any appointments
available. That didn’t stop me from
trying the link every waking hour or
so, expending not only time but also
emotional energy, and getting more and
more disappointed with every dead end.
The email told me it was my time,
so my appointment had to be in that
system somewhere! I was determined
to stick with what would ultimately be
a fruitless search.
A few days later, the same link took
me to a new webpage. Finally, I was able
to enter a date to request an appoint-
ment. My current company provides
software and data quality assurance,
46 || QP || June 2021
Quality 4.0 and the Digital Revolution
so (of course) the first thing I did was
request an appointment date of Jan. 1,
2016 to see what would happen. What
better way to beat a pandemic than to
be prepared far in advance?
No luck, though: No appointments
available for that date. The system gave
me the option to request a vaccination
on any of the 4,017 days between then
and Dec. 31, 2026, so surely something
would be available next week, or even
next month. But there was nothing.
Eventually, I found another way
to get a vaccination appointment:
Completely bypass this system. It’s
good that they didn’t attempt a more
sophisticated artificial intelligence
(AI)/machine learning (ML) system
to match people with the right brand
of vaccine and the best time to receive
it because they would have fallen far
short of that goal.
Why was my experience so frustrat-
ing? Why did I look for different ways to
iStock.com/NB_Factory
get the job done? Why was the vaccine
distribution effort ill-prepared to drive
value through AI or ML? Because each
of the problems I encountered shares
a root cause: issues with data quality. 
What’s good enough?
Data quality is challenging in many
ways. Problems can be introduced and
exacerbated in so many places, and can
compound over time as people manipu-
late and interact with the data—or let it
gather dust.
For example, a typo or slipped finger
might affect data quality right at the
point of entry. The software’s user inter-
face might be programmed to accept
values that aren’t legitimate (such as
the date selector I encountered try-
ing to get my vaccination), or may
not have adequate validation.
The interface might be pro-
grammed to accept values
that the database hasn’t
been prepared to receive.
The way the values were
measured can make them
useful or useless. A business
user accessing data through a
dashboard or business intelli-
gence system (BIS) might choose
the wrong field for the problem he
or she is solving, or misunderstand
what that field actually represents.
Also, people on the business side
think about data quality differently
than those in IT. If you’re on the busi-
ness side, you’re asking: “Can I use this
data? Do I trust it?”
If you’re on the technology side,
you’re concerned with whether the
right constraints or triggers are on your
database, or whether completeness, con-
sistency and uniqueness requirements
are met. You’re naturally attuned to dif-
ferent perspectives and languages that
describe what “good” actually means.
To make things even more com-
plicated, not all people have the same
requirements for “good” data.
Consider customer records. Market-
ing departments might need to ensure
that email addresses connect with
real people who are part of your target
market. Account executives might care
about whether the customer record
When you leverage dig-
ital systems to improve
quality, the quality of
the data directly will
affect the quality of
the outcomes.
represents someone who’s interested in
buying more. A product manager might
care only whether the customer records
for people in focus groups are accurate,
complete and not duplicated.  for the business.
Can I use it? Can I trust it? Are these
data fit for use? Key stakeholders will
have their own unique answers to these
questions. Figuring out what “good”
means—and making sure data quality is
good enough for everyone’s needs to be
met—doesn’t have to be overwhelming
and doesn’t require a multimillion-dollar
investment in a chief data officer (CDO)
and a specialized staff.
At any sized company, you
might feel powerless to be a
champion for change in which
data quality is concerned.
But whether your data
quality initiatives are
enterprise-wide or grass-
roots, you personally can
take steps that will help you
(and your CDO, if you have
one) advance data quality at your
organization:
– Think like a CFO—When
data quality improves, what busi-
ness outcomes do you want to see?
Why do you need better accuracy,
consistency, completeness or valid-
ity? Don’t invest in improving data
quality just to make the data better.
Data quality also should drive spe-
cific, measurable quality outcomes
qualityprogress.com || QP || 47
THE DOWNLOAD
– Apply the Pareto principle—Focus
on data quality for the most import-
ant data sources and data flows. For
many organizations, only a small part
of the data ecosystem drives the bulk
of the business value. But first, you
have to find it.
– Promote visibility—To find them,
data flows must be visible to the
businesspeople and engineers
who use them, and there must
be a shared understanding of the
concepts and high-level process.
Map the links between the incom-
ing raw data, the tasks to clean
and process it, the reports or other
locations where the processed data
appear, and the business questions
the stakeholders ask when they
examine them.  to benefit from improved data quality,
– Shorten time to interpretability—
Shared data dictionaries are essential,
but too often, they are difficult to
understand. Make sure it’s easy for
anyone who works with data to find
out exactly what that data mean,
how they were collected or created,
and who is responsible for them.
– Eliminate one-way streets—Being
able to go back and recover from
errors is important, so make sure
that your raw data, clean data
and processed data are preserved.
Especially for audits that require the
ability to get a snapshot of your data
at a point in time, make sure that your
processes don’t delete or overwrite
data that may be needed later. Some
data lakes come with these capabili-
ties built in.
– Don’t archive everything—Storage
is cheap, and there are bound to be
48 || QP || June 2021
earth-shattering insights in all
the data you can collect right now
… when you can get around to
mining it. Even though it might
be tempting to save everything,
don’t. 
– Establish lean governance—
Knowing the rules that govern
how people and data interact is
essential. Who can interact with
your data under what circumstances
and when? Where is the data coming
from? Why is it being produced? How
is it monitored and controlled?
– Recognize that data quality soft-
ware is not an instant win—Don’t
fall into the trap of deciding to
improve data quality by purchasing
an expensive system that makes big
promises. Without the other points in
place—and especially data governance
processes that make sense to the peo-
ple who interact with the data—the
software only will be a placebo.
It’s always about data quality
Here’s an example of how these
fit together:
I’ve been working with an organi-
zation that wants to migrate and test
nearly 200 reports and the automated
tasks that produce them.
By shifting from a legacy BIS to one
that’s more flexible and maintainable,
the organization hopes it will have
more control over data quality.
Rather than leaping into migration,
we made the data flows more visible
and traced backward from the business
questions to the parts of the system that
supported them.
Taking this approach showed that
only 15 reports and a subset of the data
sources in the organization’s data eco-
system were essential. 
PLAN TO ATTEND
ASQ’s Quality 4.0 Summit is scheduled
for Oct. 25–27 in San Antonio, TX.
The theme of the event is “Quality
4.0: Advances, Adoption and Advo-
cacy.” Visit asq.org/conferences/
quality-4-0 for further details.
For the past few years, I’ve been help-
ing organizations of all sizes get ready
for digital transformation initiatives.
These organizations are anxious to
automate—and even more eager to use
data science and ML to catalyze contin-
uous improvement.
But without a solid foundation in
data quality and data management,
their initiatives are bound to deliver
less than expected or fall flat. 
Data quality is the cornerstone. When
you leverage digital systems to improve
quality, the quality of the data directly
will affect the quality of the outcomes.
You don’t need to invest millions
but you do need to treat it as a busi-
ness problem rather than a technology
problem.  QP
Nicole Radziwill is senior
vice president of quality
and strategy at Ultranauts
Inc. in New York. She holds
a doctorate in technology
management (quality systems) from Indiana State
University in Terre Haute. She is an ASQ fellow and
an ASQ-certified Six Sigma Black Belt and quality
manager. Radziwill is the author of Connected,
Intelligent, Automated: The Definitive Guide to Digital
Transformation and Quality 4.0 (Quality Press, 2020)
and the former editor of Software Quality Professional.
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 FIELD
Zooming in on industry-specific issues
COVID -19
Authorization vs.
Approval
he COVID-19 pandemic
T
has negatively affected
the entire world, causing
historic social and economic
disruption. The metrics of
confirmed cases and confirmed deaths,
especially in the United States, are
certainly depressing and make us all
wonder when this will end and what
the new normal will look like.
In this fight against COVID-19,
measures such as social distancing
and wearing masks reduces the chances
of being exposed to the virus, but they
are not enough. More robust solutions,
such as vaccines, are necessary.
Among the responsibilities of the
U.S. Food and Drug Administration
(FDA), the federal regulatory body
charged with protecting public health,
is reviewing lab data and clinical trials
to ensure vaccines, such as the ones
developed to combat COVID-19, meet
safety, efficacy and quality require-
iStock.com/Dmitrii_Guzhanin
ments—in terms of purity and potency.
The extreme urgency that surrounds
developing a vaccine to fight COVID-19
and bringing the world back to some
type of normalcy has brought to light
the differences between formal FDA
A rundown of the process of issuing an
emergency use authorization for vaccines
by Ajit Basrur
approval of a vaccine and the FDA’s
emergency use authorization (EUA).
This column walks through the differ-
ent stages of EUA taken by the FDA,
helps differentiate between authori-
zation and approval, and describes
the controls the FDA has established
to ensure the vaccine’s safety, effec-
tiveness and quality. The Centers for
Disease Control and Prevention (CDC)
and the FDA say the processes in place
make the vaccine safe and effective.
What does EUA mean?
The EUA is part of the Project BioShield
Act of 2004 that was designed in the
wake of the Sept. 11, 2001 terror attacks.
The measure provides additional and
more flexible authorities and funding
to financially support the development
and procurements of medical counter-
measures (MCM) against chemical,
biological, radiological and nuclear
(CBRN) threats.
The act also gives the FDA Commis-
sioner the authority to issue EUAs to
allow the use of unapproved medi-
cal products or unapproved uses of
approved medical products (including
vaccines) during CBRN emergencies.
NOTES
The EUA process is an expedited one
and is different than an FDA approval.
Under an EUA—given the urgency due
to the pandemic—the FDA makes a
product available to the public based
on the best available evidence without
waiting for all the evidence that would
be needed for a regular FDA approval.
In the case of vaccine approval, the
manufacturers must submit a biolog-
ics license application (BLA). For its
COVID-19 vaccine, for example, Pfizer
submitted its EUA with only a couple of
months of data. Usually, a BLA requires
several months of data to ensure
continued safety, purity and potency.
To issue an EUA, the FDA evaluates
the chemistry, manufacturing and
controls information for the vaccine,
using all its available tools and infor-
mation—including records review, site
visits and previous compliance history—
to assess compliance with current good
manufacturing practices. In short, the
FDA ensures the vaccine’s safety, effec-
tiveness and quality, and works with
the vaccine developers and undertakes
a rigorous evaluation of the scientific
information through all phases of
clinical trials, which continues after
qualityprogress.com || QP || 51
FIELD NOTES
a vaccine has been approved by the FDA
or authorized for emergency use.
Summary of EUA issuance
process
The process of issuing an EUA involves
four steps.1
1. Determination of an emergency:
This is issued either by the Depart-
ment of Defense Secretary for
military emergency or significant
potential for military emergency;
the Department of Homeland Secu-
rity (DHS) Secretary for domestic
emergency or significant potential
for domestic emergency; the Depart-
ment of Health and Human Services
(HHS) Secretary for public health
emergency or significant potential
for public health emergency; or the
DHS Secretary for a material threat.
In the case of COVID-19, the
Secretary of Health and Human
Services (HHS) on Feb. 4, 2020,
determined—pursuant to his author-
ity under section 564 of the Federal
Food, Drug and Cosmetics (FD&C)
Act—that there was a public health
emergency that had a significant
potential to affect national security
or the health and security of U.S.
citizens living abroad. This threat,
of course, involved a novel (new)
coronavirus (nCoV) first detected
in Wuhan City, Hubei Province,
China in 2019 (2019-nCoV).2
2. Declaration of an emergency:
Based on the determination of the
public health emergency on Feb.
4, 2020, the HHS Secretary also
declared that circumstances existed
to justify the authorization of emer-
gency use pursuant to section 564
of the FD&C Act, on the same day.3
This declaration is specific to EUAs
and is not linked to other types of
emergency declarations.
3. Issuance of EUA: The FDA Com-
missioner, in consultation with the
HHS Assistant Secretary for Pre-
paredness and Response, the CDC
and the National Institutes of Health,
issued the EUA. The FDA publishes
52 || QP || June 2021
public notice of each issued EUA
in the Federal Register.
Currently, there are three
COVID-19 vaccines authorized by
the FDA. On Dec. 11, 2020, the FDA
issued the first EUA that allows the
Pfizer-​BioNTech COVID-19 vaccine
to be distributed in the United
States.4 On Dec. 18, 2020, the FDA
issued an EUA that allows the
Moderna COVID-19 vaccine to be
distributed in the United States for
use in individuals 18 years of age and
older.5 On Feb. 27, a third EUA was
issued to Johnson & Johnson.6
“We recognize the urgent need
to develop a safe and effective
vaccine to prevent COVID-19 and
continue to work collaboratively
with industry, researchers, as well
as federal, domestic, and interna-
tional partners to accelerate these
efforts. While the FDA is committed
to expediting this work, we will not
cut corners in our decisions and are
making clear through this guid-
ance what data should be submitted
to meet our regulatory standards,”
said FDA Commissioner Stephen
M. Hahn, M.D. “We have not lost
sight of our responsibility to the
American people to maintain our
regulatory independence and ensure
our decisions related to all medical
products, including COVID-19 vac-
cines, are based on science and the
available data.”7
4. Termination of declaration of
EUA: In most cases, an EUA will
remain in effect until it is revised or
revoked by a subsequent FDA order.
The FDA may specify a duration (for
example, one year) for an emergency
dispensing order, but it also may
extend the order as appropriate.
As a result of the continued conse-
quences of the COVID-19 pandemic,
and after consultation with public
health officials as necessary, the
HHS Secretary on Jan. 7 renewed
the determination that a public
health emergency exists.8 This
was the fourth determination with
previous ones issued on April 21,
2020; July 23, 2020 and Oct. 2, 2020.9
Future EUAs
The FDA published a guidance docu-
ment to provide sponsors of requests
for EUAs for COVID-19 vaccines with
recommendations regarding the data
and information needed to support the
issuance of an EUA under section 564
of the FD&C Act (21 U.S.C. 360bbb-3)
for an investigational vaccine to pre-
vent COVID-19 for the duration of the
COVID-19 public health emergency.10
Robust oversight process
A lot has changed since the pandemic
hit us in early 2020. Being a well-knit
globalized community, the COVID-19
virus spread rapidly and affected sev-
eral countries and citizens around the
world. This prompted the World Health
Organization, regulators and several
agencies from different countries to
authorize and support the development
and procurement of MCMs to contain
the growing pandemic.
The FDA, in particular, could not
have responded so quickly without its
robust oversight process that ensures
these unapproved but authorized
MCMs comply with safety, efficacy
and quality requirements. Through
these efforts, let’s hope we can put
the pandemic behind us as soon as
possible.   QP
EDITOR’S NOTE
References listed in this article can be found
on this column’s webpage at qualityprogress.com.
Ajit Basrur is the manager
of quality systems at Bose
Corp. in Framingham,
MA. He holds a bachelor’s
degree in microbiology from
Mumbai University in India. Basrur is a senior member
of ASQ and an ASQ-certified medical device auditor
and pharmaceutical GMP professional.
New ASQ
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S TAT I S T I C S S P OT L I G H T
Solving quality quandaries through statistics

DESIGNED EXPERIMENTS

Thou Shall
Confirm Confirmation and validation using independent
data are a characteristic of good science, good
analytical studies by Ronald D. Snee

ou have completed a designed that offer brief mentions of confirma- These studies are from personal experi-

Y
experiment project, which
included some confirmation
runs that were predicted
accurately by the design of
experiment (DoE) model. There is the
nagging question: “Will the model pro-
duce accurate predictions over time?”
The statistician George E.P. Box told
us that “all models are wrong, but some
are useful.”1 Will this model be useful
in the long run?
Model validation has been of interest
for a long time.2 Many textbooks on DoE
and regression analysis check model
accuracy by performing lack-of-fit tests,
doing residual analyses and assessing
the model adjusted R-square and root
mean square error statistics. All these
checks are important and necessary,
tion runs.6-8
An old proverb states that, “The
proof of the pudding is in the eating.”
In other words, you must try food to
know whether it is good. In terms of
quality, you only can judge something’s
quality (or fitness for use) if you have
tried, used or experienced it.
In the case of problem solving, pro-
cess improvement and DoE, you must
validate findings with independent
data—particularly in the case of empir-
ical models because validation may
continue over the life of the model.
Of critical importance is the broader
question: “How do we confirm the
findings of projects that do not involve
confirmation runs?” This question
covers all types of problem solving and
ence accumulated over several years.
Model verified as it was used
A lubricant blending study was designed
to develop a model to determine the
amount of additive needed to produce
a lubricant with desired viscosity given
the composition of the blend.9
The 18 blends in a blending design
were evaluated, and a viscosity predic-
tion model was developed.
The usefulness of the model was
evaluated by analyzing the prediction
accuracy associated with formula-
tions developed for eight customers
over subsequent months. The results
were outstanding.
The model prediction accuracy was
less than 0.04% of the measured value.
iStock.com/Vectorios2016

but they are insufficient.
While there is renewed interest in
confirmation studies, 3-5 classic text-
books do not mention confirmation
runs. But there are three exceptions
improvement endeavors. Where does
the independent data come from?
What follows is a series of case
studies illustrating various types of
assessments of “problem solutions.”
Because each customer application
was based on the model prediction,
the resulting data could be used to
assess model prediction accuracy
as long as the model was in use.10

54 || QP || June 2021
Model prediction accuracy
assessed using the given data
A frequently used approach to check
the prediction accuracy of regression
models—given a set of data such as that
collected on a manufacturing process—is
to split the total data set into the estima-
tion set (sometimes call the training set),
and the prediction set is used to check
the model accuracy.
There is a better way to split the
data when the data are collected over
time, which is frequently the case: Split
the data on time of collection using the
initial data to build the model and the
latter data set to check the model pre-
diction accuracy. This simulates how
the model will be used over time.
A major question is, of course,
what time point do you use to
split the data? This point often
is easy to determine given the
data pedigree.
Donald Marquardt and
I wrote about a corn yield
study involving data col-
lected during a four-year
period covering four distinct
growing seasons.11 The data
from years one to three were
used to build the models and
prediction accuracy being deter-
mined from the year four data. Such
an approach simulates how the model
will be used over time.
Before and after studies
In almost all projects, there are “before”
and “after” phases. Indeed, every proj-
ect report should include data and plots
of what the performance was before
the recommended process change was
implemented, and what the process per-
formance looked like after the process
change. Such an approach—illustrated
with appropriate graphics—clearly
demonstrates the effect of the project
recommendations.
A case in point is the newspaper
accuracy study.12-13 The error rate in
the newspaper was too large, and a
study was initiated to identify how to
reduce the errors. A Pareto analysis
of data collected during a two-month
period identified four major sources of
errors (before phase). Process changes
in the form of new procedures were
identified and deployed. Analysis of
the next month of data (after phase one)
produced disappointing results: There
was no change in the error rate.
After investigation, it was discov-
ered that the new procedures were not
being used because it was believed that
“management was not serious about
implementing the new procedures.”
An “all-hands” meeting was held, and it
You must validate find-
ings with independent
data—particularly in
the case of empirical
models because valida-
tion may continue over
the life of the model.
was communicated in no uncertain
terms that management was serious,
and the new procedures were to be used.
The next month’s data were analyzed,
and a 40% reduction in errors was
observed (after phase two). Over the
next six months, errors were reduced by
60 to 70% (after phase three). This case
illustrated that the after phase may take
a while to become truly effective.
Look broadly for
confirmation opportunities
In some projects, you find solutions but
have no internal data to use to confirm
the results. Sometimes, it’s helpful
to look outside your organization for
opportunities to confirm your findings.
Consider these case studies that illus-
trate such opportunities.
An ambient carbon monoxide (CO)
modelling study used data collected
by government agencies in 1962—1971.14
An analysis of these data showed that in
a given year, there was a linear relation-
ship between the standard deviation
and average of the data. Such a relation-
ship is characteristic of a log-normal
distribution. This analysis used data
from six major U.S. cities involving about
82 “location-years” of data. The question
was: “Are there other data at different
locations that could support or refute
the log normal distribution finding?”
It was learned that New Jersey had
an extensive CO sampling program.
The analysis of the associated data
(99 “location-years” collected
between 1965 and 1973) demon-
strated that the log-normal
model was appropriate,
and the standard devia-
tion-average relationships
were similar. This result
led to the conclusion that
log-normal model assumption
was appropriate for CO model-
ling studies.
Earlier in my career, I worked on
another study at DuPont that involved
the analysis of the results of mutation
studies. It had been established that
many chemicals cause mutations on their
way to causing cancer.
Cancer studies are expensive and
take two years to complete in animals.
Mutation testing is done in a few days
in a lab. Mutation testing is a big deal
for chemical companies because a false
positive or false negative result could
produce erroneous conclusions regard-
ing the cancer-causing potential of the
compound. As a result, it is important
to have a good, defensible method for
analyzing the data.
You can see quickly that repeat
mutation tests have a non-normal
distribution that is skewed to the right.
Because of the importance of muta-
tion testing, it was decided that the
qualityprogress.com || QP || 55
S TAT I S T I C S S P OT L I G H T
power transformation model would
be used to identify the appropriate
transformation to be used in the anal-
ysis.15 The DuPont labs’ data analysis
indicated that a power transforma-
tion with lambda, depending on the
mutation test being used (lambda = 0
[log scale], 0.15 and 0.2), was the appro-
priate transformation.
Now, we had to figure out how to con-
firm this result. Was the result unique
to DuPont mutation testing or will this
model work in other labs? We learned
that the National Cancer Institute (NCI)
has done inter-lab studies on mutation
tests in several labs. The associated
data were obtained and analyzed
using the power transformation model.
The DuPont results were confirmed by
the labs in the NCI program.16-18
Use what you have
When analyzing study results, you must
watch for opportunities to confirm the
results of the analysis. These case stud-
ies illustrate such opportunities:
A formulation study was designed
to determine the effects of five compo-
nents on the hardness of plastic parts.19
One of the blends in the design couldn’t
be tested because the plastic part pro-
duced was too soft. The hardness of the
other 20 blends varied from four to 300
units. The quadratic blending model
fit the data well, yielding an adjusted
R-square value of 98%.
The loss of the blend that was too
soft to measure was a concern until it
was realized that the blend could be
used to check the prediction accuracy
of the model. The predicted value for
the hardness of the blend was 2.5 units,
which was smaller than the smallest
measured hardness value of four units.
Thus, a potential problem was turned
into an opportunity. In this case, it added
credibility to the prediction of the model,
at least at low hardness levels
The goal of a new product devel-
opment study was to identify a better
product—that is, a product with less
impurity than the existing product.
Three factors were studied in a 23-run
56 || QP || June 2021
optimization experiment. One factor
was found to have no effect over the
ranges studied. A combination of
the other two factors minimized the
impurity. A new product was found.
The predicted measured impurity of
this combination was about 50% lower
than that of the current product.
A bonus was that the model devel-
oped accurately predicted the impurity
of the old product, which was well out-
side the region of the experiment. This
suggested that the model could be used
in the future to identify formulations for
other applications, which could produce
low impurity levels.
Thou shall confirm
You should be a bit skeptical of proposed
problem solutions. Always ask, “Is this a
useful solution? Will it work short-term?
Long-term? Please show me the data.”
Every problem solution, process
improvement and predicted process
optimum operating conditions should
be confirmed with data collected inde-
pendently of the data used to produce
the result. Thou shall confirm!
Confirmation and validation using
independent data are a characteristic of
good science and good analytical stud-
ies. Confirmation should be considered
a best practice to be used in all analyt-
ical studies. Confirmed and validated
solutions add credibility to the results of
the problem-solving process, as well as
increasing the credibility of the team or
individual who conducted the study.  QP
© Ronald D. Snee 2021
REFERENCES
1. George E.P. Box and Norman R. Draper, Empirical
Model-Building and Response Surfaces, Wiley, 1987.
2. Ronald D. Snee, “Validation of Regression Models:
Methods and Examples,” Technometrics, Vol. 19,
1977, pp. 415-428.
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 is an honorary member of ASQ and has received ASQ’s Shewhart,
Grant and Distinguished Service Medals. He is an ASQ fellow and an academician in
the International Academy for Quality.
3. Willis A. Jensen, “Confirmation Runs in Design of
Experiments,” Journal of Quality Technology, Vol. 8,
No. 2, 2016, pp. 62-177.
4. Nathaniel T. Stevens and Christine M. Anderson-
Cook, “Design and Analysis of Confirmation
Experiments," Journal of Quality Technology,
Vol. 51, No. 2, 2019, pp. 109-124.
5. Christine M. Anderson-Cook and Lu Lu, “Statistics
Spotlight: Why Not Sequential DoEs?” Quality
Progress, November 2020, pp. 44-47.
6. Douglas C. Montgomery, Design and Analysis
of Experiments, 10th edition, Wiley, 2020.
7. Raymond H. Myers, Douglas C. Montgomery
and Christine M. Anderson-Cook, Response Surface
Methodology: Process and Product Optimization
using Designed Experiments, Wiley, 2016.
8. C.F. Jeff Wu and M.S. Hamada, Experiments:
Planning, Analysis and Optimization, Wiley, 2009.
9. Ronald D. Snee, “Designs for Quadratic Models in
Constrained Mixture Spaces,” Technometrics, Vol. 17,
1975, pp. 149-159.
10. Ibid.
11. Donald W. Marquardt and Ronald D. Snee,
“Ridge Regression in Practice,” American Statistician,
Vol. 29, 1975, pp. 3-20.
12. Ronald D. Snee and Roger W. Hoerl, Leading
Holistic Improvement With Lean Six Sigma 2.0,
FT Prentice Hall, 2018.
13. Roger W. Hoerl and Ronald D. Snee, Statistical
Thinking—Improving Business Performance,
third edition, Wiley, 2020.
14. Ronald D. Snee and J.M. Pierrard, “The Annual
Average: An Alternative to the Second Highest Value
as a Measure of Air Quality,” Journal of Air Pollution
Control Association, Vol. 27, 1977, pp. 131-133.
15. George E.P. Box and Dennis R. Cox, “An Analysis
of Transformations,” Journal of the Royal Statistical
Society, Series B, Vol. 26, No. 2, 1964, pp. 211-252.
16. Ronald D. Snee and J.D. Irr, “Design of a Statistical
Method for the Analysis of Mutagenesis at the
HGPRT Locus of Cultured Chinese Hamster Ovary
Cells,” Mutation Research, Vol. 85, 1981, pp. 77-93.
17. Joseph D. Irr and Ronald D. Snee, “A Statistical
Method for Analysis of Mouse Lymphoma L5178Y
Cell TK Locus Forward Mutation Assay: Comparison
of Results Among Three Laboratories,” Mutation
Research, Vol. 97, 1982, pp. 371-392.
18. Ronald D. Snee and Joseph D. Irr, “A Procedure
for the Analysis of Ames Salmonella Assay Results:
Comparison of Results Among Four Laboratories,”
Mutation Research, Vol. 28, 1984, pp. 115-125.
19. Ronald D. Snee and Roger W. Hoerl, Strategies for
Formulations Development: A Step-by-Step Guide
Using JMP, SAS Press, 2016.
 S TA N DA R D I S S U E S
Standards-related developments and activities
AS9104
Major
Overhaul
n early 2000, the International Aerospace
I
Quality Group (IAQG) developed the globally
harmonized industry controlled other party
(ICOP) scheme. This was meant to support
the certification of AS9100/9110/9120 avia-
tion, space and defense (ASD) organizations’
aerospace quality management systems (AQMS).
The certification scheme is built on existing
International Accreditation Forum (IAF) and Inter-
national Organization for Standardization (ISO)/
International Electrotechnical Commission (IEC)
requirements for certifying an organization’s quality
management system (QMS). ISO/IEC certification
criteria, as supplemented by unique ASD require-
ments, best summarizes this approach.
What is ICOP?
ICOP describes the IAQG and industry-managed
certification scheme for auditing and certifying
an organization’s AQMS by accredited other-party
certification bodies (CB), in accordance with the
requirements defined in the AS9104-series standards.
The objective is to support AQMS certification with
active industry participants and to hold all parties
in the scheme accountable for conformance.
IAQG established a trilogy of ASD standards to
support deploying and overseeing the ICOP scheme
(see Figure 1, p. 58). The standards are:
–
iStock.com/olegback
AS9104-1—Requirements for the certification of
aviation, space and defense quality management
system certification programs.
Significant revisions to
AS9104-1 improve the value of
AQMS certification by Tim Lee
– AS9104-2—Requirements for the oversight of avia-
tion, space and defense quality management system
certification programs.
– AS9104-3—Requirements for aviation, space and
defense auditor training, development, competence
and authentication.
Figure 2 (p. 59) shows the ICOP management process.
Change
Requirements have changed over time, and the ICOP
scheme requirements must change as well. A major
revision to AS9104-1 is coming this year. IAQG is
in the final stages of re-balloting and publishing a
revised AS9104-1 certification requirements standard.
These highly anticipated changes incorporate lessons
learned and strengthen the alignment between the
ASD industry and IAF. The ultimate objective of this
revision is to improve the value of AQMS certification
and increase stakeholder confidence.
OCAP
One key change to AS9104-1—and a real game
changer—is a new interactive organization certifica-
tion analysis process (OCAP). The process enhances
understanding of the organization's context, identifies
organization risk and ensures audit time calculation
is driven by verifiable data, which should lead to a
value-added AQMS audit and associated report.
The ICOP scheme requires CBs to use OCAP
to support management of the AQMS certifica-
tion program. In conjunction with applicants
qualityprogress.com || QP || 57
S TA N DA R D I S S U E S

FIGURE 1

ICOP scheme
IAF requirements The ICOP Scheme ASD
and peer review 9104-2 oversight authorities

IAQG

IAQG-OPMT
Author Training
Accreditation bodies authentication provider approval
ISO/IEC 17011 & 9104-1 bodies bodies
9104-3 SMS
9104-3
Accredit Authenticate Approve
RMS
Accredited certification bodies Authenticated Training
ISO/IEC 17021-1, IAF MDs & 9104-1 Employ auditors Train providers

Certify Audit
9104-2
oversight
Organization certification analysis process (OCAP) and
feedback
Year 0 9100-9110-9120 Year 3
data
Surveillance–9101

Initial
Certified organizations Recertification Data Online aerospace
certification
supplier information
system (OASIS) database

Recognize, manage and oversight per 9104-1, 9104-2 and 9104-3

ASD = aviation, space and defense IEC = International Electrotechnical MD = mandatory document
IAF = International Accreditation Forum Commission OPMT = other party management team
IAQG = International Aerospace Quality Group ISO = International Organization RMS = registration management structure
ICOP = industry controlled other party for Standardization SMS = sector management structure

and certified organizations, the CB performs a com-
prehensive analysis of the organization’s QMS scope,
site structure, certification audit program and risk
analysis prior to each initial surveillance or recertifica-
tion audit. The results and supporting information are
documented and retained.
The process steps are depicted in the revised AS9104-1
standard, as shown in Figure 3.
CBs in the ICOP scheme must clearly understand the
context of the organization that is seeking AQMS cer-
tification. This ensures the correct AQMS standard is
selected and supports creation of the certification scope.
Scope statements summarize the organization’s products,
services and supporting activities (such as manufacture,
design, repair, distribution, servicing or testing, for exam-
ple), and align with the organization’s AQMS.
IAQG has simplified the certification structure require-
ments and eliminated the use of multiple certification
structure options. Going forward, the ICOP scheme no
longer will use campus or several site certification struc-
tures. The revised certification audit program is based
on single or multiple site certification structures only.
The determination and justification for the certification
structure is documented by the CB.

58 || QP || June 2021
 FIGURE 2 organization continually maintains a conforming
and effective AQMS that meets ASD customer

ICOP management process

expectations. This process replaces the IAF process
for advanced surveillance and recertification proce-
dures (IAF MD3:2008). Certified organizations are
rewarded with an appropriate reduction in audit time
9104-001
upon successful implementation and maintenance of
this process.

9100
9110
Next steps
9120 AS9104-1 was scheduled for a six-week re-ballot in
9104-003 9104-002 March. Upon successful ballot, the target for publication
ICOP industry is August. After AS9104-1 is published, a comprehensive
Auditor training
control and supplemental rule document will be available. The sup-
and authentication
oversight plemental rule will contain timelines for implementing
these revised requirements and transitioning existing
ICOP = industry controlled other party AQMS certification programs.

FIGURE 3

Organization certification analysis process steps

Organizational Certification audit AQMS risk Audit
context program analysis time

AQMS = aerospace quality management system

The use of an AQMS risk analysis is the real game changer.
The ICOP certification process uses performance-based
elements for risk analysis that include on-time delivery,
conformity of delivered product or service (such as item escape
rate), customer satisfaction and AQMS process effectiveness.
The results of this documented analysis are used
to increase audit time when risks are high, or reward
high-performing, “low-risk” organizations with audit time
reductions. In addition, if access to audit results data is
granted, this data may be available to support a customer’s
external provider control processes.
Performance-based surveillance/
recertification process
The implementation and maintenance of an optional sur-
veillance and recertification process is available in this
revision. The qualification and continued use of this pro-
cess is based on a certified organization’s performance,
including objective evidence and demonstration that the
Ultimately, the goal of the ICOP scheme is to improve
AQMS performance and increase stakeholder confidence.
Our scheme will use competent aerospace auditors with
sufficient audit time to conduct a value-added audit and
provide a comprehensive audit report to the industry
that reflects the current AQMS health of a certified ASD
organization.  QP
Tim Lee works in supplier quality at the Boeing Co.
in Kansas City, MO, and holds industry leadership
positions in the International Aerospace Quality
Group, including other-party management team
oversight chair and Americas Aerospace Quality Group registration
management committee voting member. He received a bachelor’s of
business administration degree in management. A member of ASQ,
Lee is the international document representative and project lead for
AS9104-1, and a team member on multiple standards initiatives.

qualityprogress.com || QP || 59
MARKETPL ACE Newly released products and tools

FUSES

Petite and powerful

A prominent UMT-H surface mount ceramic fuse family now includes
40 A and 50 A current ratings with a breaking capacity rating of 500 A
at 125 VAC/72 VDC.
The series was developed by Schurter, a Swiss manufacturer of electrical
and electronic components, and provides unprecedented overcurrent and
short-circuit protection performance in a package size of 5.3 x 16 mm.
The UMT-H originally was developed to provide a smaller alternative
to through-hole mounted 5 x 20 mm cartridge fuses, commonly used for
primary circuit protection. The range has since grown to include 26 rated
currents from 160 mA to 50 A.
Rated voltage is maximum 277 VAC/250 VDC, with an interrupt capacity
rating of 1,500 A for current ratings up to 6.3 A. The time-lag T character-
istic of the UMT-H withstands high inrush and pulse currents. Its 277 VAC
rating is intended for use in circuits using one of three-phase wiring schemes,
common with commercial and industrial lighting in the United States.
www.schurter.com | 707-636-3000

FORCE TESTERS

Producing easy-to-read test results

There’s a new test machine that can better perform force testing and produce test
results that are easier to read and export for further analysis.
The digital Chatillon CS2 Series of force testers can perform the most commonly
used tests in most industries—from basic static force testing to multistage testing
and cyclic. The CS2 Series force testers feature a large working area of up to
180 mm that allows the operator flexibility to not only test the product, but also
test its packaging with a simple grip change.
The CS2 Series is available in two load capacities, with the CS2-225 for testing
up to 1 kN (225 lbf) and the CS2-1100 for testing up to 5 kN (1,100 lbf). Both force
testers provide operators with an intuitive, easy-to-use touch-screen console.
The user interface makes performing tensile testing, compression testing, flexural
testing or advanced multistage testing that conforms to International Organization
for Standardization or American Society for Testing and Materials standards a breeze.
www.ametektest.com | 727-538-6000

60 || QP || June 2021
 AR SMART GLASSES A U T O M AT I O N

Eyeing Controlling
the right motion control
solution A new soft memory controller (MC) compact micro-
controller lets any original equipment manufacturer's
Touted as the new generation of augmented reality (AR) smart programmable logic controller (PLC) seamlessly con-
glasses, Epson has released its new Moverio BT-40 and BT-40S trol any motion control component—including robots,
innovative eyewear. drives and motors—to add innovation and modularity
Epson, a Japanese electronics manufacturer, said the new inno- to packaging systems.
vative smart glasses offer users a wider field of view (FOV), full HD Specifically, the new softMC lets packaging
1080p display resolution, high contrast, improved connectivity and machine-builders interface with Rockwell Automation
a more comfortable, adjustable and easy-to-wear design. PLCs and EtherNet/IP networks
With a wide 34° FOV at a comfortable position for the eyes, to add multi-axis motion control to
the Moverio BT-40 and BT-40S deliver a unique heads-up, any existing system. The controller
hands-free experience with higher resolution equivalent to delivers Industry 4.0 machine-to-
viewing a 120-in. screen from a distance of 15 ft. machine communication while
The smart glasses also feature improved connectivity in a new simplifying and reducing the overall
headset design with advanced weight distribution and optional cost of motion control system design
nose pads, which allows for enhanced comfort. An up to 500,000:1 and configuration. At the same time,
contrast ratio lets unused display space appear transparent, softMC increases the flexibility and
and an improved aesthetic design offers glasses-style form factor efficiency of automated packaging
and optional dark shades. The binocular design offers a see-through lines and expands OEMS’s capabilities
Si-OLED display. to innovate.
www.epson.com/usa  | 800-463-7766 www.stxim.com | 630-408-7033

P O W E R S U P P LY

Rugged for harsh environments

A new dual channel power supply—specific for marine engine
control—​has made a splash on the marketplace.
Called the ENMA500D24/2x27-CC, the dual channel power
supply technology can provide two 27 V/20 A isolated outputs
and a total power of 540 W. The power supply is housed in a robust
IP56 case, it is mechanically designed for efficient conduction cooling,
and it complies with DNV/GL standards.
Developed by PowerBox, a European power supply company,
the ENMA500D24/2x27-CC is powered by the low voltage 24 V
distributed supply to electronics equipment. It also can tolerate
a wide operating range of 18 to 36 V, and is able to accommodate
a large voltage drop down to 10V for 10 seconds.
In addition, the ENMA500D24/2x27-CC delivers 27 VDC/20 A
and a total power of 540 W, and has an efficiency superior to 85%.
www.prbx.com | 603-310-5200

qualityprogress.com || QP || 61
FOOTNOTES
Beyond Compliance Design
Of a Quality System
JANET BAUTISTA SMITH AND ROBERT ALVAREZ | QUALITY PRESS |  PETER MERRILL | QUALITY PRESS | 2020 | 256 PP. |
2020 | 120 PP. | $28 MEMBER | $40 LIST (BOOK).
Much has been published about how to develop a sustainable,
documented quality management system (QMS) in organizations
seeking certification to one or more of the internationally recognized
standards. Similarly, much has been published about how to prepare
an organization for maintaining its certifications that are subject to
external scrutiny and validation by auditors of the external certifica-
tion bodies.
In a concise and practical manner, the authors share a series
of best practices they developed or were involved with on how
to develop a QMS aligned with auditors' expectations.
The book is divided into 10 chapters, each of which covers a strategy
for developing a robust and sustainable QMS designed to support
the organization’s mission and business objectives. Chapter one sets
the tone for the remaining nine chapters, where topics that are aligned
with the requirements of ISO 9001 are covered.
A critical element of any QMS is risk analysis. Chapter four pro-
vides guidelines on detecting and measuring visible and hidden risks,
as well as opportunities for improvement, by applying the process grid
walk tool as an integrated part of the auditing-beyond-compliance
concept. By using a five-step process, auditing beyond compliance
provides extended benefits to the organization.
Chapter 10 highlights the difficulties some organizations have in
conducting effective management reviews, and introduces a model for
conducting the reviews to gain their intended benefits. Each chapter
includes several scenarios relevant to the covered concept followed by
lessons learned, and concludes with the authors’ perspectives. Useful
templates also are included.
This is a valuable resource for any organization embarking on imple-
menting a QMS, as well as those that are struggling with maintaining
and improving their existing QMS and are fearful of losing their
certification whenever they are audited by a certification body.
—Herzl Marouni, Houston
62 || QP || June 2021
Additions to your quality library
ISO 56000: Building an
Innovative Management System
 
$42 MEMBER | $60 LIST (BOOK).
This book provides an overview of the ISO 56000 series
of standards, but the real focus is on ISO 56002, innovation
management, which has been designed to integrate with
ISO 9001 using the high-level structure, so that an integrated
system can be developed to drive quality and innovation.
The book then addresses the key clauses of ISO 56002
by chapter, including context, leadership, planning, support,
operation, performance management and improvement.
The benefit of ISO 56000 is it gives customers, business
partners, funders and academia the confidence that an
organization can deliver innovation consistently.
The author discusses this technical and potentially dry
topic with an energy and interest deserving of innovation.
He provides an understanding of innovation in everyday
language using ISO 56002 as the guide and infrastructure.
The book is interesting and moves quickly, with quotes
from Peter Drucker, Henry Ford, W. Edwards Deming,
Peter Senge and others, and includes examples of innovation
and its challenges from Ford, General Motors, IBM, Kodak,
Apple, Lego and Zappos.
The author addresses an often-asked question about how
innovation and standards can work together, and provides
rich descriptions of how innovation can be harnessed and
managed. There also is a section on how to create a culture
of innovation, and the book includes a tool to assess innova-
tion culture. It ends with a path forward, including initial plans,
phases, ideas and suggestions.
This is an interesting and well-written book on a new,
emerging series of ISO standards that will be of partic-
ular use to those involved in innovation, management
and auditing.
—Denis Leonard, Northern Ireland
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 T R Y THIS
TO DAY
A new twist on an established quality concept
irst established in Japan by
F
Toyota, the 5S method has
grown in prominence and
is used in a wide variety of
industries. As a special project
manager at a heat-treatment plant,
I was tasked with governing our 5S
program. Using the foundations set by
5S as a guide, I created a new system
that incorporates the fundamentals
of 5S while being more accessible and
realistic for a modern heat-treatment
facility. I call it “best in SHOW.”
Sitemap and SHOWroom example
SHOW is an acronym for safety,
housekeeping, organization and work-
flow. Roughly translated from Japanese,
the pillars of 5S are sort, set in order,
shine, standardize and sustain. With
the goal of updating the method for our
needs, I started with the most important
and fundamental need of a workplace:
safety and housekeeping.
Next, while I appreciated 5S’s atten-
tion to detail with regard to labelling,
permanently demarking an area in our
job shop—which has a wide assortment
of customers and materials on the floor
at any given time—for one specific pur-
pose was unrealistic. Instead, what I took
away from the 5S pillars “sort” and “set in
order” was the importance of organiza-
tion: keeping an orderly workplace so any
64 || QP || June 2021
Best in
SHOW
tool or part can be found in moments for
the benefit of employees and customers.
When I discussed my project with
my supervisor, he recommended
workflow as another pillar of my new
system. Again, it adapts 5S principles
for our purposes by promoting a more
efficient workplace.
Safety, housekeeping, organization and
workflow: The SHOW was on the road.
Measuring success
Any initiative must be measurable and
actionable. I needed a method of mea-
suring the system’s success and how it
was affecting our plant, and I needed a
way to take action to correct problems
where they appeared.
When we first established 5S at our
plant, we divided the shop floor into six
zones. Each zone had a few employees,
or team members, assigned to it and a
zone champion to guide the employees.
For SHOW, I subdivided the zones
into smaller areas called SHOWrooms
(see Photo 1). Each employee now is
responsible for a specific part of the
plant. The last 30 minutes of every shift
are SHOWtime. Employees are expected
to ensure their areas are best in SHOW.
With the help of a graphic designer,
I created large banners for each zone.
Prototype SHOW banner
Updating 5S
principles for
a modern heat-
treatment facility
by Tim Griffin
The banners display the SHOWcase
(an example of the zone looking its best),
the SHOWman (the zone champion) and
the SHOWoff (a team member recog-
nized for outstanding performance).
(See Photo 2 and Online Photo 1, which
can be found on this column’s webpage
at qualityprogress.com.) The banners
keep the SHOW program in the forefront
of employees’ minds and also recognize
those who are making an extra effort.
Additionally, we set up a bulletin
board near our production schedule.
Each week, I pin up black-and-white
example photos of the plant not being
best in SHOW. I give color copies of the
photos to the zone champions, who in
turn give them to their team members.
This gives the champions an opportunity
to work directly with their team and take
ownership of the program. When the
problem has been fixed, the color photo is
pinned on top of the black-and-white one.
Thus, as the week progresses, the board
gradually comes to full color as we reach
best-in-SHOW status.
Upgrade
5S has stood the test of time and has
innumerable benefits to a modern work-
place. This doesn’t mean that it can’t be
updated or even upgraded. 5S is not for
everyone and not for every plant, but
everyone can be best in SHOW.  QP
Tim Griffin is a special
projects manager for
Bodycote Thermal
Processing in Covington,
GA. He received a bachelor’s
degree in music from Reinhardt University in Waleska,
GA, and is a certified Six Sigma Yellow Belt.
GLOBAL INSIGHTS SAY FUTURE LEADERS
NEED THESE SKILLS THE MOST
The foundational data set established by ASQExcellence’s Insights
on Excellence (IoE) study provides ASQE and ASQ members with
real-world insights to inspire a culture of quality.

The research identifies emerging industry trends, including data

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what skills need the most improvement in their workforce, one
in four global respondents indicated that change management,
Download the 2020 Insights on
strategic implementation and the ability to work effectively with
Excellence Annual Research Report
cross-functional teams need the most attention.
on insightsonexcellence.org,
Use the IoE research to illustrate the importance of quality’s role and discover the complete IoE
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ASQE is a trade association focused on serving organizations.

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To learn more, visit asq.org/membership