Asqm Asqm0715 PDF

QUALITY PROGRESS | JULY 2015
Putting Best Practices to Work
www.qualityprogress.com | July 2015
Strumming
Up Business:
Quality Guitar
Strings
p. 24
QUALITY PROGRESS
QUALITY
SS
ISO 9001:2015S EFFECT ON OTHER STANDARDS
Change on the
Horizon
Plus:
Flip the switch
to quality p. 30
Test your improvement
theory p. 36
VOLUME 48/NUMBER 7
The Global Voice of Quality
TM
ISO 9001:2015 precipitates

revisions to other
standards p. 18
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Contents
Putting Best Practices to Work | July 2015 | www.qualityprogress.com
FEATURES
18
18
STANDARDS
Open to Change
The ISO 9001 revision is scheduled for release in September. Find

out how business sectors will handle revisions to their own guidance
documents in the coming years.
by R. Dan Reid
24
SMALL BUSINESS
Passion Project
Quality concepts such as total quality management struck a chord

with a musical strings manufacturer and help it continually tune up
operations.
by Luke T. Foo
30
BEST PRACTICES
Turning on the Light Bulb
Seven critical reflection methods to help quality newcomers understand

and fully embrace quality principles.
by John Robert Dew
36
ORGANIZATIONAL IMPROVEMENT
Whats Your Theory?
A new way to develop, test and refine theories to improve a process,

redesign a service or create new products.
ONLY @
www.qualityprogress.com
by Brandon Bennett and Lloyd Provost
Stay Connected
30
Subscribe to ASQs latest free

enewsletter, Standards Connection,
for the latest ISO 9001 revision news
and expert standards information.
Volviendo a los
Fundamentos
Back to Basics translated

into Spanish.
Read All About It
Get the latest Quality News

Today (QNT) headlines.
DEPARTMENTS
6
LogOn
Expert Answers
12
14
58
60
12
Removing the silo effect.

Can quality slow innovation?
Switching ANSI standards.
QUALITY PROGRESS
Mail
Automakers use of common

parts can compound problems.
Argentinian team takes gold at WCQI.
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COLUMNS
5
44
46
Author Guidelines
Up Front
Ripple effect.
Measure for Measure

Metrological traceability
to non-SI units.
Quality in the First Person

Dealing with substandard
ISO 9001 training.
54
48
Career Corner
51
Statistics Roundtable
Hiring manager offers advice

to job interviewees.
Wrongly rejecting the null
hypothesis in statistical trials.
54
Standards Outlook
63
One Good Idea
64
BONUS
The revision of AS9100 series

standards ready for takeoff.
12 principles to create more
product value in less time.
Back to Basics
Hypothesis testing for unbiased

problem solving.
SPECIAL SECTION
ASQS CONTINUING
EDUCATION AND
PROFESSIONAL
DEVELOPMENT DIRECTORY p. 56
NEXT MONTH
- CREATIVITY BY DESIGN
Pairing design of experiments with creativity

leads to more efficient and effective testing.
- ALL THE RIGHT MOVES
Innovation strategies improve patient flow

and access to care at an Ontario hospital.
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UPFRONT
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QUALITY PROGRESS
Ripple Effect
EXECUTIVE EDITOR AND

ASSOCIATE PUBLISHER
ISO 9001 revision impacts other standards
Mark Edmund
Seiche Sanders
ASSOCIATE EDITOR
ASSISTANT EDITOR
SHORTLY AFTER I joined the QP staff in late 2006, discussion began heating up about
Amanda Hankel
the 2008 revision of ISO 9001. Almost nine years later (and a bit older and wiser), I
MANUSCRIPT COORDINATOR
understand much better the true impactand related angstabout the forthcoming
ISO 9001:2015 standard, especially with this revision being so much more significant
than the 2008 version.
The rewarding part of what we do is the ability to provide the quality community
impacted by the standard with the resources and information needed to help ease the
transition.
Beyond the many QP articles weve published and will continue to publish on the
topic, ASQ offers:
The ASQ Standards Channel: http://videos.asq.org/asq-standards-channel.
Valerie Ellifson
COPY EDITOR
Susan E. Daniels
CONTRIBUTING EDITOR
Tyler Gaskill
ART DIRECTOR
Mary Uttech
GRAPHIC DESIGNER
Sandy Wyss
PRODUCTION
The Standards Connection enewsletter: http://asq.org/standardsconnection.
Cathy Milquet
The International Conference on Quality Standards: http://asq.org/conferences/
ADVERTISING PRODUCTION
quality-standards/2015/index.html.
Standards Central: http://asq.org/standards/index.html.
Take advantage of these resources. Being prepared will give you an edge leading into
the standards release.
Standards take center stage in this issue of QP. Open to Change, p. 18, explains how
various business-sector standards will be influenced by ISO 9001.
... the best a sector can do if it elects to use ISO 9001 at all is to take the document as
the starting point for a more complete set of requirements needed to achieve the desired
quality levels, typically aimed at its supply chainsat least for the highest-risk suppliers, the author writes in this article. Find out why ISO 9001 is only the beginning.
Substandard Information, p. 46, shows the negative effect to individuals and organizations when ISO 9001 is misapplied or quality staff does not receive proper training.
Ensure that your organization isnt making any of the same mistakes.
Finally, the Standards Outlook column, p. 54, outlines the revision of the AS9100
series standards.
Barbara Mitrovic
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Seiche Sanders
Editor
CEO
William J. Troy
Senior Leadership
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Michael Barry
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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
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July 2015 QP
LOGON
Seen&Heard
Tune In
Integrating quality
Partnering tools
In response to Change in Flow (June
The statement in the headline of the
2015, pp. 38-46): When I worked as a qual-
article Back to Basics: 1+1 = Zero
ity engineer for an engineering, procure-
Defects (June 2015, p. 72), which refers
ment and construction company, the
the need to partner your control plan
main issues I dealt with involved ensuring
with process failure mode and effects
design specifications included the ad-
analysis (PFMEA), is very true, and I have
equate technical and quality requirements,
personally confirmed it.
and that design changes were adequately
Control is designed to support
and correctly integrated within the design
PFMEA and not to replace it. PFMEA
specifications and approved by the cus-
is championed by the manufacturing
tomer. Those changes correctly flowed
engineer, while the control plan is led by
down to the purchase order documenta-
quality.
tion.
Otin Presley Meggisson
I would add a quality engineer compe-
Ypsilanti, MI
tent in each respective discipline (process,

mechanical, civil/structural, instrumentation and electrical) to the respective
Good reminders
departments. This may help to remove
In response to Like Abilities (June 2015,
the silo effect by integrating quality into
pp. 24-29): I enjoyed the reinforcement
the departments rather than the historical
of managing social media and the need
Its in quality many departments outside
to respond to positive reviews, as well as
the quality department reject.
negative ones.
Andrew Cox
Lee Butler
Charlotte, NC
Rio Rancho, NM
Great idea from One Good Idea
I used the table in One Good Idea: The
On-the-job opportunities
Statement Problem (June 2015, p. 71) to
In response to Outside Influence (May
assist in writing clear and concise problem
2015, pp. 28-32): I wish I could have had
statements during the notification of event
the same type of opportunity as these
process, a process my organization uses
high school students had when I was
to identify an unexpected incident or
in school. The application of hands-on
deviation before opening a full investiga-
experience coupled with some class
tion. Everyone thought it was a great idea
time is more impactful. I believe that you
and loved having a visual to use as a tool
retain the information better because
versus a blank form with a section labeled
you can relate the classroom training to
problem statement.
an actual exercise.
Nikki Swopes
Sharon Poole
Lexington, SC
Marietta, GA
The latest episode of ASQ TV focuses on teams. Learn how to work

effectively with a remotely based
team, discover the project prioritization matrix and get advice from
the worlds best teams. Watch for
two new episodes this month, one
on sustainability available July 7
and another on cost
of quality available
July 28. Visit http://
videos.asq.org to
access the full video
library.
StayConnected
Find the latest news, quips and targeted
content from QP staff.
Executive Editor & Associate

Publisher Seiche Sanders:
@ASQ_Seiche
Associate Editor Mark Edmund:
@ASQ_Mark
Assistant Editor Amanda Hankel:
@ASQ_Amanda
Contributing Editor Tyler Gaskill:
@ASQ_Tyler
editor@asq.org
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groups/43461176682
www.linkedin.com/groups/qualityprogress-magazine-asq-1878386
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EXTRAS@
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QUALITY PROGRESS
www.qualityprogress.com
Learn more about ISO 14001 revision
Videos related to ISO 14001, the environmental management system standard, have been
posted to the ASQ Standards Channel. ISO 14001 is being revised in 2015 and will align
with ISO 9001:2015. Access the videos at http://videos.asq.org/asq-standards-channel.
Get published in LogOn
Submit comments, questions or opinions about articles in QP to editor@asq.org or

comment on the articles webpage. Your comments could appear in an upcoming edition
of LogOn.
PAST CHAIR
Stephen K. Hacker, Transformation Systems

International, LLC
CHAIR
Cecilia Kimberlin, Kimberlin LLC (retired Abbott)
CHAIR-ELECT
Patricia La Londe, CareFusion
TREASURER
Eric Hayler, BMW Manufacturing
SECRETARY
QUICK POLL RESULTS
Each month at www.qualityprogress.com, visitors can take an informal survey. Here are
the numbers from last months Quick Poll:
William J. Troy, ASQ
PARLIAMENTARIAN
Sue Campbell, ASQ
DIRECTORS
What efforts most enhance an organizations culture?
4.6%
11.6%
39.5%
20.9%
11.6%
11.6%
Involving the entire workforce in improvement initiatives.

Leadership engaging with frontline staff.
Encouraging risk-taking.
Offering benefits, such as training and tuition reimbursement.
Providing frequent opportunities for employees feedback.
Hosting fun, team-building activities.
Visit www.qualityprogress.com for the latest question:

How will your organization be most affected by the revision to ISO 9001?
We must transition to ISO 9001:2015 and other aligned standards, such as ISO 14001.
We plan to be certified to ISO 9001 for the first time.
We are unaffected by the ISO 9001 revision.
Donald Brecken, Ferris State University

Heather L. Crawford, Apollo Endosurgery
Raymond R. Crawford, Parsons Brinckerhoff
Ha C. Dao, Emerson Climate Technologies Inc.
Benito Flores, Universidad de Monterrey
Julia K. Gabaldn, Quality New Mexico
Edwin G. Landauer, Clackamas Community College
David B. Levy, Boyce Technologies, Inc.
Sylvester (Bud) M. Newton, Jr., Alcoa
Daniella A. Picciotti, Bechtel
Steven J. Schuelka, SJS Consulting
Kush K. Shah, General Motors
James B. Shore, Quality Lean Solutions, LLC
Jason Spiegler, Camstar Systems Inc.
Joal Teitelbaum, Escritrio de Engenharia
G. Geoffrey Vining, Virginia Tech, Department of
Statistics
QP EDITORIAL REVIEW BOARD

Randy Brull, chair
Administrative Committee
QualityNewsTODAY
Recent headlines from ASQs global news service

Just Another Day at the Crash Factory
The Insurance Institute for Highway Safety crashes about $4 million worth of vehicles
each year in the quest to identify the cars and light trucks that are safest to drive.
It does so independently, funded by insurers who support its research. Automakers
are not involved in selecting tested vehicles, nor do they provide them. (http://bit.ly/
dayatcrashfactory)
Apple Finally Opens Up, Letting You Test iOS 9
Opening up its beta software to the public is a smart, forward-thinking move. It means
that average Joesthe people who actually buy iPhonescan toy around with the
software and offer Apple feedback. (http://bit.ly/applefinallyopens)
Brady Boggs, Randy Brull, Jane Campanizzi,

Larry Haugh, Jim Jaquess, Gary MacLean,
R. Dan Reid, Richard Stump
Technical Reviewers
Andy Barnett, Matthew Barsalou, David Bonyuet,

David Burger, Bernie Carpenter, L.N. Prabhu
Chandrasekaran, Ken Cogan, Linda Cubalchini-Travis, Ahmad Elshennawy, Mark Gavoor, Kunita Gear,
Daniel Gold, T. Gourishankar, Roberto Guzman,
Ellen Hardy, Lynne Hare, Ray Klotz, Tom Kubiak,
William LaFollette, Pradip Mehta, Larry Picciano,
Gene Placzkowski, Tony Polito, Peter Pylipow,
Imran Ahmad Rana, John Richards, James Rooney,
Brian Scullin, Amitava Sengupta, Mohit Sharma,
A.V. Srinivas, Joe Tunner, Manu Vora, Keith
Wagoner, Jack Westfall, Doron Zilbershtein
WANT THE LATEST QUALITY-RELATED NEWS AND ANALYSIS? The QNT Weekly
enewsletter, available exclusively to ASQ members, delivers it every Friday.
Subscribe now at http://email.asq.org/subscribe/qntwk.
July 2015 QP
EXPERTANSWE
Integrating quality, innovation
is why innovation is so important. There
Q: Will integrating quality concepts nega-
will always be some customer needs
process. It starts with identifying unmet
tively impact the speed of innovation?
organizations cannot meet. It is these
needs or changing requirements using
How can an organization integrate quality
unmet needs that innovators must focus
techniques such as gemba, the Kano
management and innovation?
on and see as opportunities. This is why
diagram and the environmental scan.
the ASQ Innovation Division describes in-
But this phase also requires a different
novation as quality for tomorrow.
mode of thinking. You must be open-
A: If used correctly, quality concepts can

significantly enhance the speed of innova-
The creative phase also follows a
So how do organizations integrate
minded and think outside the box to see
tion. Many of the tools and techniques
quality with innovation? First, think of in-
opportunities others will miss. The qual-
used in quality managementsuch as the
novation as a process. It has two phases:
ity profession is short of these people,
Kano diagram, gemba and risk analy-
a creative phase and an execution phase.
but you can find many of them on the
sishave direct application in innovation.
Each phase has two essential steps.
marketing side of the organizationthey
However, there are additional toolsin-
The creative phase consists of seeing
are called creators. So for the creative
cluding forms of creative problem solv-
the opportunity of unmet needs and ide-
phase, its important that marketing and
ingavailable to innovate.
ating to find conceptual solutions.
quality people collaborate.1
Quality has increasingly revolved
The execution phase is where the
The next process step in the creative
around meeting customer requirements
working solution is developed and deliv-
phase is finding the conceptual solu-
by reducing internal errors. But with the
ered, and its what quality professionals
tion. This is where the quality profession
speed of change in todays business
do best. Developing and delivering the
comes in because it has many people
world, these requirements often quickly
working solution requires engineering
who are good at solving problems.
become redundant, and organizations can
efficient and effective processes and
Remember, however, that innovation is
be blind to new market opportunity. This
products.
different from improvement.

Innovators go beyond the status quo
and get radical new ideas that break the
mold. If you change steps in a process to
have the same output with greater efficiency, you are improving, not innovating.
Innovators will create an entirely new process with a radically new offering to meet
unmet customer needs. The new offering
will make the customers life much easier
and will stun the competition.
To innovate, quality professionals must
draw from the collective knowledge of
the organization and use ideation techniques beyond traditional brainstorming.
Whether by data mining, knowledge management or ideation, organizations must
extract the untapped knowledge that they
have in huge quantities. The lonely genius
is a myth.
Quality professionals also must change
their behavior to innovate. Instead of the
RS
If you change steps in a process to get the
same output with greater efficiency, you are
improving, not innovating.
proverbial banging your head against the
Organization for Standardization is devel-
measurement, it is appropriate to use
wall, give yourself thinking space and
oping an innovation management system
ANSI/ASQ Z1.9. Both plans are indexed
relax. This is not inefficient use of timeit
standard that will integrate with ISO 9001.
by the acceptable quality limit (AQL), but
is smart use of time.
Ultimately, to innovate, you must think in
have different sample size requirements
terms of a systemand thats what qual-
based on the level of protection you are
ity management provides you.
looking to maintain.
To integrate quality management and

innovation, be conscious of two different
sets of behavior in the creative phase
Peter Merrill
and the execution phase. Define your
Chair, ASQ Innovation Division
innovation process and allow the higher
President, Quest Management Systems
degree of freedom that is needed in the
Burlington, Ontario
creative phase while your traditional quality management system (QMS) gives you
the structure you need in the execution
phase. Finally, let a system guide you
through the processBaldrige criteria,
Can you switch from a variable plan

(Z1.9) to an attribute plan (Z1.4) for your
inspection to align with your suppliers
use of Z1.4? Though I do not believe harmonizing with the suppliers use of Z1.4
REFERENCE AND NOTES

1. Use the ASQ Innovation Divisions self-assessment tool
to identify creators in your team and organization at asq.
org/innovation-group.
2. For more information, read Peter Merrill, Embracing
Change, Quality Progress, September 2014, pp. 44-45.
ISO 9001 or the European Foundation for
for your acceptance testing is necessary,

it is possible to use Z1.4 by redefining the
variable measurements as either good or
not.
Choosing to move to Z1.4 from Z1.9 will
Quality Management excellence model
Switching standards
increase your sample size for the same
are good examples.
Q: We are using ANSI/ASQ Z1.9 for a
level of protection and same lot size. For
Dont get caught up in the stodgy ISO
dimension test of packaging components.
example, a lot size of 5,000 would have a
9001 implementation of the 1990s. Your
Because dimension is a variable measure-
sample size of 70 in Z1.9 and 200 for Z1.4
QMS can be agile if you want it to be. ISO
ment, can we switch to ANSI/ASQ Z1.4
for a general inspection level II plan. Both
9001:2015 will enable you to integrate
to align with our supplier who is using
plans give approximately the same AQL
innovation into your QMS. It starts with
it? Is this switch acceptable? If yes, what
and lot tolerance percentage defective,
defining the context of the organization
should be considered?
though the Z1.4 will require 2.67 times
in clause 4 and looking at the market,
more samples.
competition and economy and finding
A: The ANSI/ASQ Z1.4 standard is for in-
opportunity.2
coming inspection of attribute character-
At the same time, the International
istics. Because measurement is a variable
Steven Walfish
Chair Z1, U.S. TAG to ISO/TC 69
Staff statistician, Becton Dickinson
Wayne, NJ
ASKED AND ANSWERED
Let QP help you solve those tough quality-related questions. Submit your question
at www.qualityprogress.com, or send it to editor@asq.org, and our subject matter
experts will help you find a solution.
July 2015 QP
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KEEPINGCURRE
AUTOMOTIVE
Common Parts, Common Problems
Takata recall magnifies risks of global automotive platforms, use of same suppliers
General Motors (GM), Ford, BMW, Honda,
product commonality in vehicles and the
amount of vehicle architectures, or plat-
Toyota, Fiat Chrysler Automobiles (FCA),
use of the same suppliers among auto-
forms, on which they build their models,
Subaru, Mitsubishi, Diamler Trucks, Mazda
makers.
meaning more models contain common
and Nissan: 11 of the largest, most well-
A recall of this scope illustrates the
known automakers in the world continue
potential for massive automaker expense
to add models to a growing list of vehicles
and consumer inconvenience when a
Andreas Radics, 24% of all manufactured
that contain potentially dangerous air bag
common, mass-produced part is defec-
vehicles in 2014 were built on 10 big plat-
inflators manufactured by auto parts sup-
tive, said Karl Brauer, a senior analyst at
forms worldwide. That percentage could
plier Takata Corp.
parts.
According to research by consultant
climb to 30% by 2020 and further
Japan-based Takata acknowledged
increase the need for common parts
last month its air bag inflators could
that can be interchanged among vari-
explode when deployed and spew
ous models.
metal shrapnel at drivers and pas-
Volkswagen was the first major
sengers. This admission resulted in a
OEM to adopt this concept on a large
recall of 33.8 million vehicles in the
scale. The automaker can build more
United States and another 7 million
than 40 vehicle models on one plat-
worldwidethe largest auto recall
formits front-wheel drive modular
in history and one of the largest con-
transverse matrix (MQB) architecture.
sumer products recalls ever.
The MQB platform standardizes the
The problem already has been
engine position and the distance
blamed for six deaths and 100 inju-
between the front axle and pedal box.
ries, and a definitive root cause still
The width, length and wheelbase can
hasnt been identified. The focus of
change based on the model.
the investigation, however, has been
GM is moving from 30 core and
on a propellant in the air bag inflators
regional platforms in 2010 to 26 in
called ammonium nitrate, which can
2015, and eventually to four flexible
degrade over time and explode in certain
Kelley Blue Book. Ironically, the use of
platforms by 2025, according to a report
conditions, such as high humidity. Takata
common parts across markets and manu-
by consulting firm Strategy&. Toyota,
said its analyses show a majority of cases
facturers is meant to save money, yet a
too, is rethinking and simplifying how it
involved the use of a batwing-shaped
recall of this size will cost the industry
builds its vehicles by adopting a modular
propellant wafer.
billions.1
platform called the Toyota New Global
The widespread impact of the recall
Architecture, which maximizes the use of
on so many makes and models points to
Modularization, consolidation
the risks of a growing trend within the
The adoption of global platforms means
auto industry among othersglobaliza-
automotive original equipment manufac-
cost savings by adopting global platforms
tion and adoption of global manufacturing
turers (OEM) are increasing the number
because sharing common components
platforms, which have resulted in greater
of models they offer while reducing the
enhances flexibility, increases volume,
12 QP www.qualityprogress.com
common parts.
The thought is that OEMs can achieve
E NT
streamlines product development, and
allows for the costs of product development and manufacturing tools to be
spread across more vehicles.
There are significant savings in material costs, engineering costs, installation, investment and validation, said
Volvo R&D chief Peter Mertens. If you
have one architecture and dont have to
do everything for each vehicle, you can
NAME: Minda Chiang.
Whos Who in
RESIDENCE: Hong Kong.

EDUCATION: Masters degree in quality and reliability at the
University of Warwick in Coventry, England.
INTRODUCTION TO QUALITY: Quality was introduced to Chiang during a food technology course in which a few modules mentioned quality and enlightened her about the
importance of quality in food manufacturing.
CURRENT JOB: Quality assurance manager at HealthBaby Biotech Co.
save a lot.2
Last year, FCA said it will derive
95% of its vehicle production in 2018
from nine global platforms. It had 12
platforms in 2013. Sharing purchasing
and engineering, FCA expects to save
about $2 billion.
The savings come in all these
buckets, said Chrysler purchasing
chief Scott Kunselman. For [product]
development, common platforms, common suppliers, economies of scaleIm
seeing [savings] in every instance.3
Another aspect of global platforms
is the use of common suppliers across
models and automakers. According
to the Strategy& report, Ford plans to
reduce its supplier base from 1,150 to
750, and other OEMs plan to do the
same.
While using common parts and
reducing suppliers can result in savings,
Ltd. in Hong Kong, which adopts advanced storage and processing

equipment to ensure the life-long storage of customers stem cells.
PREVIOUS JOBS: Deputy quality assurance manager at Jean-Marie
Pharmacal Co. Ltd. in Hong Kong. There, Chiang started her journey
in developing, training, validating, maintaining and auditing good
manufacturing practices (GMP) for manufacturing drugs in all major
therapeutic categories, including injection products. She helped establish Hong Kongs
first sterile-injection production line, which met the health departments GMP requirements. As a result, Hong Kong GMP certification was obtained for sterile and nonsterile
operations in 2002. This experience led to an opportunity to lead a team to establish a
quality system for a new biological drug and to pursue international qualification, including Pharmaceutical Inspection Cooperation/Scheme requirements.
ASQ ACTIVITIES: Chiang is honorary secretary of Hong Kong Society for Quality (HKSQ),
assisting in organizing seminars and technical visits for members of HKSQ and ASQ in
Hong Kong. She also acts as an assistant proctor for ASQ exams held in Hong Kong.
OTHER ACTIVITIES/ACHIEVEMENTS: In 2008, Chiang was named chartered quality professional by the Chartered Quality Institute. She also has taught quality management at
universities for more than 10 years and has developed a short course on GMP and quality assurance for the pharmaceutical industry in Hong Kong, which she has conducted
since 2013.
air bag market, defective air bag infla-
PUBLICATIONS: Chiang has co-authored two articles about water quality: A Continuous
Improvement Process at Severn Trent Water, TQM Magazine, 2002, Vol. 14, No. 5, pp.
284-292, and The Use of MUG Supplement to Detect Escherichia Coli by the Multiple
Tube Method in Marine Waters of Hong Kong, Marine Pollution Bulletin, 1999, Vol. 38, No.
10, pp. 921-924.
tors mass produced and placed in sev-
RECENT HONORS: Elected to ASQs 2014 class of fellows.
it also means quality problems can have

a larger impact. In the case of Takata,
which controlled more than 30% of the
eral models among 11 automakers have

resulted in a huge and complex recall
that could take years to complete.
PERSONAL: Married.
FAVORITE WAYS TO RELAX: Having a hot cup of coffee outdoors.
QUALITY QUOTE: Ethics is the cornerstone of quality.
(continues on p. 14)
July 2015 QP 13
KEEPINGCURRENT
Takata recall (continued from p. 13)
Takata has said it can make millions
of new air bags in a year but likely cant
produce the tens of millions needed to
al quality director at Valeo, an automotive

supplier in Germany.4
Radics said quality involvement
replace all the defective ones. As a result,
must be taken even one step further as
some automakers have had to turn to
global platforms become the future of car
other suppliers for replacements.
manufacturing.
In addition, about 400,000 replacement air bags that had been installed to
repair previously recalled vehicles will
need to be replaced again because they
contain the batwing-shaped propellant
wafer that could be causing the problem.
Quality is paramount
of increased globalization, modularization
BIBLIOGRAPHY
While using common parts

and reducing suppliers
can result in savings, it
also means quality
problems can have
a larger impact.
To prevent more recalls like this in an era
Common parts with the same speci-
and consolidation among automakers and
fications from various countries and on
suppliers, consultant Radics said auto-
different tools must be manufactured in
makers and tier-one suppliers must inte-
a way that they are absolutely identical in
grate their quality managers even more
quality, he said, so that they can be in-
into the product development process.
stalled at any other factory at any time.5
In addition, OEMs must work closely
compiled by Amanda Hankel,
with suppliers to maintain quality stan-
assistant editor
dards. When there are new product

launches, we train our suppliers in the appropriate methods and processes when
necessary and go into their factories to
make sure there is a stable production
process, said Sabine Woytowicz, region-
Mr. Pareto Head
3. David Sedgwick, Carmakers Bet on Big Global Platforms to Cut Costs, Automotive News, Aug. 4, 2014,
http://bit.ly/1QEZhvv (case sensitive).
4. Wilhelm Missler, With the Push for Standard Parts,
Quality Is Key, Automotive News, Aug. 6, 2014, http://
bit.ly/1HWzkmH (case sensitive).
5. Ibid.
REFERENCES
1. Drew Harwell, Flawed Takata Air Bags in 34 million
Vehicles Lead to Biggest Recall in History, Washington
Post, May 19, 2015, http://wapo.st/1KksMmQ (case
sensitive).
2. Nick Gibbs, VW Extends Lead in Common ArchitecturesBut There Are Risks, Automotive News Europe,
June 6, 2013, http://bit.ly/1IpCZfo (case sensitive).
Agence France-Presse, Takata Still Searching for Root

Cause of Deadly Airbags, June 3, 2015, http://yhoo.
it/1F44pTs (case sensitive).
Atiyeh, Clifford and Rusty Blackwell, Massive Takata
Airbag Recall: Everything You Need to Know, Including
Full List of Affected Vehicles, Car and Driver, June 5,
2015, http://bit.ly/1tnc5yX (case sensitive).
ConsumerReports.org, Everything You Need to Know
About the Takata Airbag Recall, June 5, 2015, http://bit.
ly/1E8HOaC (case sensitive).
Greimel, Hans, Toyotas Massive Engine Overhaul,
Automotive News, July 14, 2014, http://bit.ly/1IpDg23
(case sensitive).
Isidore, Chris, Takata Recall Shock: Replacement Airbags
Must be Replaced, CNNMoney, June 2, 2015, http://
money.cnn.com/2015/06/02/autos/takata-airbagrecall.
Ivory, Danielle and Hiroko Tabuchi, Takata Says it Will
No Longer Make Side Inflater Linked to Airbag Defect,
New York Times, June 1, 2015, http://nyti.ms/1FErRrZ
(case sensitive).
Krisher, Tom, General Motors, Subaru Models Added to
Massive Takata Air Bag Recall, Associated Press, May
29, 2015, http://bit.ly/1FLs5fN (case sensitive).
Krisher, Tom, Mazda Adds 540,000 Vehicles to Takata Air
Bag Recall, Associated Press, http://abcn.ws/1GlyPG1
(case sensitive).
Rogers, Christina, Volkswagen Plans 4 Million Cars From
One Platform: VWs Modular Unit Will Be the Basis for
More Than 40 Models Worldwide, Autoweek, April 11,
2012, http://bit.ly/1F9ejmy (case sensitive).
Strategy&, 2015 Auto Industry Trends, www.strategyand.pwc.com/perspectives/2015-auto-trends.
Woodyard, Chris, Automakers Add Millions More Cars
to Takata Air Bag Recalls, USA Today, May 29, 2015,
http://usat.ly/1KBX5GC (case sensitive).
BY MIKE CROSSEN
ASQ TEAM EXCELLENCE AWARDS
ARGENTINIAN TEAM REACHES GOLD STATUS

Argentinas Movistar-Telefnica de Argentina Weaving a Quality
Network team was awarded gold-level status at ASQs International
Team Excellence Awards after showcasing how it improved its organizations quality and efficiency.
ASQ announced the achievementalong with other winnersat
its World Conference on Quality and Improvement in Nashville, TN,
which was attended by nearly 3,000 people, the conferences largest
attendance since 2000. In the awards 30th year, 36 finalist teams
from 12 countries competed for gold, silver and bronze status.
Four other teams were recognized after achieving bronze-level
status:
AlcoaPower and Propulsion, APP Process Management
team, Whitehall, MI.
BNY Mellon International Operations Private Ltd., GAMO, Pune,
ARGENTINAS MOVISTAR-TELEFNICA de Argentina Weaving a
Maharashtra, India.
Quality Network team celebrates achieving gold-level status at
MovistarTelefnica de Argentina You Can Do It! team,
ASQs International Team Excellence Awards.
Buenos Aires.
Wipro, Wipro PEX, Pune, Maharashtra, India.
For more information about the award recipients, the team excellence award process and how to participate in the 2015-2016
process, visit http://asq.org/wcqi/team-award.
BALDRIGE
26 ORGANIZATIONS
APPLY FOR 2015
BALDRIGE AWARD
The 26 organizations that have applied for the 2015 Malcolm Baldrige National Quality Award include two small
businesses, four educational organizations, 16 healthcare
organizations and four nonprofits.
Working in teams over the summer, members of the
volunteer board of Baldrige examiners will evaluate applicant organizations against the seven categories of the
2015-2016 Baldrige Criteria for Performance Excellence:
leadership, strategic planning, customer focus, measurement, analysis and knowledge management, workforce
focus, operations focus and results.
In late August, the Baldrige Performance Excellence Programs judges panel will determine which organizations will
receive site visits by examiner teams to verify information
in the application and clarify questions that come up during
the review. From those site-visited organizations, the 2015
Baldrige Award recipients will be selected in November.
For more information about the award and program, visit
www.nist.gov/baldrige.
ASQ
HROMI, ASQ PAST PRESIDENT

AND HONORARY MEMBER, DIES
John D. Hromi, an ASQ former president and honorary member, has died.
He was 94.
Hromi was a professor emeritus for Rochester Institute of Technologys Quality and Applied
Statistics Center, which was named after him in
1992 because of his well-established reputation
as an international authority in industrial statistics
and quality control. He had worked at the New York
university since 1981, having served as professor
and the centers executive director.
HROMI
Hromi was named an honorary ASQ member in
2004 for his exemplary service as a practitioner, educator and consultant
in the field of quality management and applied statistics principles and
techniques. Hromi was named an ASQ fellow in 1961 and served as ASQ
president in 1981. He was the recipient of the ASQs Grant and Lancaster
awards in 1987 and 1996, respectively, its Edwards Medal in 1993 and its
Distinguished Service Medal in 2001.
For more about Hromis selection as an ASQ honorary member, visit
http://tinyurl.com/asq-hromi. For a complete obituary, visit http://tinyurl.
com/hromi-obit.
July 2015 QP 15
KEEPINGCURRENT
ASQNEWS
NEW BALDRIGE JUDGES Two of the
three new judges recently appointed
by the U.S. Secretary of Commerce to
the Baldrige Panel of Judges are ASQ
members Miriam Kmetzo, executive vice
president of Welding Technology Corp. in
Farmington Hills, MI, and John Timmerman, a senior strategist for customer
experience and innovation at Gallup in
Washington, D.C. Timmerman is also a
past ASQ chair. Kmetzo and Timmerman
were named to the panel in May. For
information about the panel and the appointments, visit www.nist.gov/baldrige/
new_judges_2015.cfm.
LEADERSHIP SCHOLARSHIP Katie Berman, vice president of implementation
for an education technology
company, has
been awarded
the first Paul
Borawski Scholarship to support
her participation
in a year-long
BERMAN
ASQ leadership
development program. With the award,
Berman, of Curriculum Advantage Inc.
in Lawrenceville, GA, will be part of a
21-member cohort in the ASQ Emerging Quality Leaders Program, which will
include corporate visits, leadership seminars, virtual coursework, mentor support
and team projects. The scholarship is
named for Borawski, who retired last

year after leading ASQ in various roles
for 27 years. For more information about
the award, visit http://bit.ly/leadershipscholarship.
TCC EVENT SCHEDULED The second annual Joint Technical Communities Conference will be held Oct. 22-23 in Orlando, FL.
The theme of the event is Expanding the
Gift of Quality. For details about keynote
speakers and conference programs, visit
http://asqtcconference.com.
AWARD APPLICATIONS AVAILABLE
Nomination forms are now available
for ASQ awards and scholarships to be
presented at the 2016 ASQ World Conference on Quality and Improvement May
16-18 in Milwaukee. ASQ has established
many awards to recognize individuals for
superior achievements in the development, promotion, implementation and
communication of quality information
and technology. For more information,
visit http://asq.org/about-asq/awards/
index.html or email Karen Prosser at
kprosser@asq.org. Nominations are due
by Oct. 1.
INSPECTION CONFERENCE SET ASQs
Inspection Division will hold its annual
conference Sept. 10-11 at the University
of Dayton in Ohio. Topics such as risk
management, gage repeatability and
reproducibility, calibration, and geomet-
ric dimensioning and tolerancing will be

covered. For more information about the
event, visit www.asq.org/inspect.
SCHOLARSHIP RECIPIENT ASQs
Healthcare Division awarded its annual
$2,000 Nightingale Scholarship to Erin Van
Landingham, a graduate student studying dementia and aging at Texas State
University in San Marcos. Van Landingham was recognized for demonstrating
an outstanding commitment to pursuing
quality improvement in the healthcare
field. Visit http://bit.ly/asq-nightingale for
more information about Van Landingham
and the award.
ASQ HEALTHCARE Division Chair Bill

Dunwoody (left) presents Erin Van
Landingham with ASQs Nightingale
Scholarship.
29TH SALARY SURVEY OPENS QPs 29th

annual salary survey is being conducted
the entire month of July. Visit www.
qualityprogress.com and follow the link to
take this years 10-minute survey. Results
will be published in Decembers QP.
HEALTHCARE
SURVEY EXAMINES NURSING PRACTICES IN HOSPITALS

About 40% of hospitals do not comply
with specific industry-endorsed safe
practices related to the nursing workforce.
The 21 National Quality Forum (NQF)endorsed safe practices on nursing
werent always followed by the hospitals surveyed by the Leapfrog Group, a

healthcare advocacy organization. The
percentage of hospitals that achieved
full compliance on the 21 nursing workforce safe practices did grow from 52%
in 2013 to 60% in 2014.

The findings are based on data taken
from the 2014 Leapfrog Hospital Survey of
1,501 U.S. hospitals.
For more specific information from the
survey, visit www.leapfroggroup.org/cp.
ASQ TV
STANDARDS CHANNEL ADDS 4 NEW VIDEOS TO COLLECTION

The ASQ Standards Channel has released four new
revision. More bundles of videos are scheduled to
videosthis time interviews with experts discuss-
be unveiled in the coming months as the revisions
ing the revision of the ISO 14001 environmental
formal release, slated for later this year, nears.
management standard.
The channel (http://videos.asq.org/
asq-standards-channel)launched earlier this
Those who watch the videos can earn 0.025

recertification units for every 15 minutes of footage
they view.
yearalready has more than 20 videos of stan-
Nonmembers cost is $30 per video, or $179 for
dards experts discussing the basics and key chang-
a year of full access to the channel. ASQ members
es of the ISO 9001 quality management standard
have full access to all of the videos.
ASQ JOURNAL SPOTLIGHT

QP occasionally highlights an open-access article from one of
ASQs seven other journals.
This month, read Offshore Output,
which appeared in the May edition of
Six Sigma Forum Magazine (SSFM).
Authors Vijaya Sunder and Jiju
Antony describe how a bank used lean
Six Sigma to increase employee utilization in offshore operations.
To access the 13-page article in PDF
format, click on the Current Issue link
on SSFMs webpage: http://asq.org/
pub/sixsigma.
From there, you also can find a link to information about subscribing to the quarterly publication.
FROM THE BASICS TO THE BOARDROOM
www.sixsigmaforum.com
WORDTOTHEWISE
To educate newcomers and refresh practitioners and professionals, QP occasionally features a quality term and definition.
Advanced product
quality planning
High-level automotive process for product realization, from
design through production part approval. Arranging machines in
the correct process sequence, with operators remaining within
the cell and materials presented to them from outside.
SOURCE
Quality Glossary, Quality Progress, June 2007, p. 40.
DATEINQUALITYHISTORY
QP occasionally looks back on an event or person that
made a difference in the history of quality.
July 7, 1868
Frank Bunker Gilbreth Sr., an early advocate of scientific management and pioneer of motion study, was
born on this date in Fairfield, ME.
When he was a young building contractor, Gilbreth
looked for ways to make bricklaying faster and easier.
Later, he studied the habits of manufacturing and
clerical employees in all sorts of industries to increase
output and make their jobs easier.
He and his wife, Lillian Moller Gilbreth, founded a
management consulting firm, Gilbreth Inc., to teach
managers that all aspects of the workplace should be
constantly questioned and improvements constantly
adopted.
Gilbreth is known as the first to propose that a
surgical nurse serve as caddy (Gilbreths term) to a
surgeon by handing surgical instruments to the surgeon as called for. Gilbreths work is often associated
with that of Frederick W. Taylor.
Taylor, however, focused on reducing process time,
while the Gilbreths sought to make processes more
efficient by reducing the motions involved.
Gilbreth is also remembered as the father and central figure in the book Cheaper by the Dozen, written
by his son, Frank Jr. The book inspired two films of the
same name.
SOURCE
Absolute Astronomy, www.absoluteastronomy.com/topics/frank_bunker_gilbreth.
July 2015 QP 17
CHANGE
How expected revisions
to ISO 9001:2015 may affect
sector-specific standards
by R. Dan Reid
In 50 Words
Or Less
Sector-specific standards
often include language
from ISO 9001 to address
quality management systems requirements.
Changes expected to
ISO 9001:2015including those related to new
definitions and requirementswill certainly
affect how individual sectors, such as automotive,
aerospace and medical
devices, handle upcoming revisions to their own
guidance documents.
EDITORS NOTE: This article was nalized before the ISO 9001 nal
draft international standard (ISO/FDIS 9001:2015) was completed in
July. Some issues covered in the article may have been resolved since
this edition of QP went to press in June.
ISO 9001, THE international consensus standard for quality

management systems (QMS), has long been the core supplier of QMS
requirements for several large sectors, including automotive, aerospace and medical devices. In the years after the release of the first
version of ISO 9001 in 1987, many in the International Organization
for Standardization (ISO) were opposed to the deproliferation of standards, resisting the sectors needs for more prescriptive requirements
than could be agreed to in the international consensus standard.
STANDARDS
Headline Goes
In This Area
Deck goes here
by Author Name
In 50 Words
Or Less
Text for 50 words or

less is Vectora Roman
9 on 11 with hanging
indents.
indents.
indents.
indents.
FIRST THREE WORDS are Vectora Bold 18 pt all

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se venis ad dunt lum ip ea facidunt ea am, veleniam volortinit
July 2015 QP 19
Some sector-specific documents were already cre-
The words procedure and record are not in-
ated by that timefor example, QS-9000 for the au-
cluded in the mandatory text for the QMS require-
tomotive industry. International voluntary standards
ments from ISO Directives Part One, Annex SL.2 They
developed by ISO must go through the same open and
are replaced with the term documented information
transparent process to achieve the highest level of con-
to provide more flexibility in the QMS documentation
sensus possible, which is not so for the sector docu-
needed.
ments. ISO standards are generic, which means they
The problematic issue of exclusions from the last
are intended to be used by any type and size of organi-
revision is replaced with text indicating that where a
zation. Existing standards are reviewed at least every
requirement in the standard can be applied, it must be
five years for continuing suitability and effectiveness.
applied. There could be some difference of interpreta-
When its decided to revise an ISO standard, it starts
tion regarding what this means.
a long iterative process of drafting, circulating for comment, revising, voting and progressing the document
How will manufacturing sectors react?
through various draft stages: First comes a working
Posted on ISOs website is an article about the upcom-
draft, then a committee draft, followed by the draft
ing ISO 9001 revision that rightly claims documents
international standard (DIS), then a final draft inter-
in the ISO 9000 family have consistently been ISOs
national standard (FDIS, which is now optional), and
best-selling standards, and they give a base-level con-
finally the documents release as an international stan-
fidence in an organizations ability to provide conform-
dard (IS).
ing products.3
This process ensures almost anything controversial
In the ISO user survey administered to determine
or innovative gets separated out to a guidance docu-
whether a revision to the QMS was needed, users in-
ment or is rejected outright. The released IS represents
dicated the main reason for seeking ISO 9001 certifica-
the lowest common denominator agreed to by the vot-
tion was customer satisfaction.
ing ISO members. It is the minimum set of require-
The success of ISO 9001 sales, therefore, seems
ments for, in the case of ISO 9001, a functional QMS for
to be driven by the manufacturing sectors use of the
all types of organizations. As such, it cannot and will
standard as the core requirement in their supplier re-
not have best-in-class requirements or methods from
quirements documents, to which they require their
various sectors because these are neither generic nor
suppliers to be third-party certified.
applicable to all.
Standards writers then must strike an acceptable
Hence, the best a sector can do if it elects to use ISO
balance between the needs of existing interested par-
9001 at all is to take the document as the starting point
ties and needs of new ones they are courting. So how
for a more complete set of requirements needed to
have they done so far?
achieve the desired quality levels, typically aimed at its

supply chainsat least for the highest-risk suppliers.
Management system defined

In the first versions of ISO 9001, there was no consen-
Reaching out to new sectors
sus definition for the word quality, even though the
ISO indicated one of the reasons for developing the
standard was released as a QMS. There is now a defi-
new revised QMS standard is to ensure that the new
nition for the term management system in the DIS,
standard reflects the needs of all interested parties.1
which is the remaining part of the QMS that has to
There is a concerted effort for the latest revision to
date been undefined. This definition introduces what
appeal to and be adopted by service sectors, with the
is likely to be an unacceptable provision to customers
broader healthcare sector being chief among them.
of ISO 9001 users.
In an effort to attract service sectors, there are sev-
Before we examine this definition in detail, know
eral changes in the revision. First, the word product
that the ISO directives say that notes to entry fol-
previously was intended to include service, but this
low different rules from notes integrated in the text ...
was not always clear to some. The new QMS standard
they provide additional information that supplements
will have a separate definition for service, distinct
the terminological data.4 Notes to entry are used in
from product.
ISO standards in clause 3, which are the terms and defi-
STANDARDS
In the ISO user survey administered to determine

whether a revision to the QMS was needed,
users indicated the main reason for seeking ISO 9001
certification was customer satisfaction.
nitions. Thus a note to entry becomes part of a terms
not know how much of an organization is covered by
definition. It is not just informative as is a note in
third-party certification without examining the scope
the other clauses of ISO standards.
statements on one or more certifications, then trying
Why is this significant? There is a note to entry

found for the definition of management system in the
to determine from these certifications whether all appropriate functions have, in fact, been covered.
DIS which indicates that the scope of a management
It would seem this provision would need to be ad-
system can be limited to specific and identified func-
dressed in sector-specific documents going forward to
tions5 or sections of the organization, or one or more
make it easier for customers to determine whether a
functions across a group of organizations.
supplier or potential supplier has a certified QMS for
The early versions of the ISO 9000 family of stan-
an entire organization so the customer can have confi-
dardsfor example, 1987 and 1994offered a QMS
dence in the organizations ability to consistently pro-
standard for three types of organizations:
duce conforming products or services.6
1. ISO 9001 for organizations with design and manufacturing capability.

2. ISO 9002 for organizations with manufacturing capability.
3. ISO 9003 for distributors.
Statistical methods
There is a requirement in the current standard for organizations to determine applicable methods, including
statistical techniques, and the extent of their use when
In these documents, the scope of the QMS was al-
planning and implementing monitoring, measurement,
ways expected to include the entire organizationnot
analysis and improvement processes.7 In the DIS, this
constituent functions or departments.
mention of statistical techniques is removed.
In the 2000 version of the ISO 9000 family, the three
The automotive sector first issued a statistical pro-
options of the requirements standards were dropped
cess control reference manual in 1992. It is still one
for customers and potential customers. Since then, if
of the core tools used by suppliers. For manufacturing
they were interested in doing business only with orga-
sectors, there are appropriate statistical methods to be
nizations with QMS certification, they needed to obtain
used at various stages of the product life cycle.
a copy of the certified organizations certificate to see
Kaoru Ishikawa indicated the majority of prob-
what was included in the certified QMS scope (for ex-
lems in manufacturing could be solved with seven
ample, design and manufacturing, or just manufactur-
basic quality tools (cause and effect diagrams, check
ing).
sheets, control charts, histograms, Pareto charts, scat-
The 2000 version introduced the notion of permis-
ter diagrams and stratification). They are called basic
sible exclusions for organizations, but offered only
because they are suitable for people with little formal
one certifiable standardISO 9001.
training in statistics and because they can be used to
With the new revision for 2015, it now appears
solve the vast majority of quality-related issues.8
an engineering center, for example, can obtain ISO
The automotive sector will likely continue to insist
9001:2015 certification apart from a manufacturing
on a QMS well-grounded in data analysis and statistical
function and other functions inside an organization, or
methods.
vice versa.
This means customers and potential customers may
There is an explicit requirement in the QMS DIS for

an organization to determine the risks and opportuni-
July 2015 QP 21
ties that need to be addressed ...9 The guidance in the
ally has third-party auditors prepare a report for each
DIS introduction indicates that what is needed is risk-
QMS requirement indicating what objective evidence
based thinking, which means considering risk quali-
the auditor used to verify conformance or nonconfor-
tatively (and, depending on the organizations context,
mance.
quantitatively) when defining the rigor and degree of

formality needed to plan and control the QMS 10
Who and what is relevant?
Manufacturing sectors have addressed risk in earli-
The DIS has expanded the scope of customer needs
er sector documents to varying degrees, but they do re-
and expectations to those of interested parties. The
quire quantitative methodsfor example, failure mode
DIS defines this term as a person or organization that
and effects analysis (FMEA). A proper FMEA will
can affect, or be affected by, or perceive themselves
quantitatively provide enough discrimination among
to be affected by a decision or activity. These include
the relative risks to help organizations prioritize work.
suppliers, people in the organization, society and even
Qualitative analysis for risk alone would likely be in-
competitors, in addition to customers. This will likely
sufficient for sectors going forward.
be a concern to some organizations.
To consider or not to consider
organizations can:
There are many things the DIS requires organizations
Determine which interested parties are relevant to
The guidance in DIS Annex A.3, however, indicates
to consider, including:
Context of an organization and the needs of interested parties when determining the scope of the
QMS and what risks need to be addressed.
Integrity of a QMS when planning and carrying out
changes.
Capabilities of and constraints on existing internal
resources when providing QMS resources.
Current knowledge in an organization when addressing changing needs and trends.
Required design and development verification and
validation when determining the stages and con-
their QMSs.
Determine which of the interested party requirements are relevant.
This means a customer requirement is subject to an
organizations determination of whether it is relevant
and, if not, it would not be obligated to address it. This
interpretation is more consistent with the environmental management system (EMS) technical committee
(TC) 207 use of the term requirement in ISO 14001.
The only EMS requirements that must be addressed
are regulatory.
For the QMS DIS, the guidance indicates that rele-
trols for design and development.
vance depends on whether something has an impact on
The issue of concern here is that consider means
an organizations ability to consistently provide prod-
the organization can opt out of addressing the subject.
ucts and services that meet specified requirements or
Consider is contrasted with the term take into ac-
enhance customer satisfaction. There could be some
count, which means an organization cannot opt out
debate about which customers are relevant to an or-
of addressing the subject. The quality objectives, for
ganizations QMS or which customer requirements are
example, must take into account applicable require-
relevant. This may be another area where sectors act
ments. Sector standard writers may view some of the
in their documents to avoid any such debate.
items to be considered earlier as requirements.

Further, auditing conformance to the revision will
Other potential areas of sector concern
be more difficult. There are now requirements that
DIS Clause 10.2.1Nonconformity and Corrective
organizations shall consider, so organizations must
Action, and DIS Clause 8.7Handling of noncon-
have evidence that they have considered these things
forming products make the requirements subject to
where they have opted not to address them. Auditors
the term as applicable. Some organizations may inter-
will have to judge the effectiveness of these decisions
pret this as providing flexibility when it comes to what
in light of the QMS performance.
requirements applyfor example, segregation of non-
Sectors may elect to change some of the DIS items
conforming material and obtaining customer approval.
to be considered to be items that must be addressed
The DIS requires an organization to react to noncon-
in their sector documents. The aerospace sector actu-
formity and, as applicable, make corrections, evaluate
STANDARDS
the need for corrective action to eliminate the cause

of the nonconformity, implement any action needed,
review the effectiveness of the corrective action and
make changes to the QMS.
This could be interpreted by some as not actually requiring root cause analysis and corrective action, but only
requiring evaluation of the need for it and opting out. Sectors have long had prescriptive requirements for a formal
corrective action process, which is likely to continue, at
least for suppliers that determine these to be relevant requirements from a relevant interested party.
More discussion inevitable

This article was based on a review of the ISO/DIS
9001:2015. Changes were made to the FDIS in July,
based on international comments received on the DIS.
After this edition of QP went to press in June, some of
REFERENCES AND NOTE

1. International Organization for Standardization Technical Committee 176
Subcommittee 23, Revision OverviewQuality Experts, presentation, July
2014, http://bit.ly/revision-overview.
2. R. Dan Reid, Into the Future, Quality Progress, March 2014, pp. 55-57.
3. Nigel H. Croft, ISO 9001:2015 and BeyondPreparing for the Next 25 Years
of Quality Management Standards, International Organization for Standardization, http://bitly.com/next25years, Aug. 28, 2012.
4. International Organization for Standardization and International Electrotechnical Committee, ISO/IEC Directives Part 2 Rules for the Structure
and Drafting of International Standards, edition 6, April 2011, clause D.4.8, p.
59, http://bit.ly/structure-and-drafting.
5. Function is defined as a role to be carried out by a designated unit of
the organization in ISO 9001:2015 Draft International StandardQuality
management systemsRequirements.
6. Croft, ISO 9001:2015 and BeyondPreparing for the Next 25 Years of Quality Management Standards, see reference 3.
7. International Organization for Standardization, ISO 9001:2008, Quality
management systemsClause 8.1 Planning, Measurement and Analysis.
8. Wikipedia, Seven Basic Tools of Quality, http://bit.ly/seven-basic-tools, May
4, 2015.
9. International Organization for Standardization, ISO 9001:2015 Draft International StandardQuality management systemsClause 6.1 Actions to
Address Risks and Opportunities.
10. International Organization for Standardization, ISO 9001:2015 Draft International StandardQuality management systemsClause 0.5 Risk-based
thinking.
the issues covered in this article may no longer exist.

Some will likely remain in whole or in part, and will
likely spark discussion and disposition by the sectors
in their revised supplier QMS requirements documents,
which will follow next year.
Meanwhile, talk with your organization and your
customers about the new standard in the coming
months and communicate to them what should be in
their sector revisions to best serve interested party
needs. QP
R. DAN REID is the director of standards and

consulting at Omnex Engineering and Management
in Ann Arbor, MI. He is an author of ISO Technical
Specification 16949, QS-9000/QSA, ISO 9001:2000, the
first International Organization for Standardization
international workshop agreement, the Chrysler, Ford,
GM Advanced Product Quality Planning With Control
Plan, Production Part Approval Process and Potential
Failure Modes and Effects Analysis manuals and the AIAG Business Operating
Systems for Healthcare Organizations. Reid was the first delegation leader
of the International Automotive Task Force. He is an ASQ fellow and an ASQcertified quality engineer.
Take the QP Salary Survey

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You know youre always curious what your colleagues are making. Now,
you can help us find answers for you. Take the 2015 QP Salary Survey
online today at www.asq.org/2015-qp-salarysurvey. The more
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thank you for your participation, at the end of the survey you can enter
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The survey runs through the entire month of July.
Well publish the results in our December issue.
Remember, the survey is anonymous, and the
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know what others on your level, in your
particular area of expertise, are making on average.
Do your part! And thanks!
2015
QP
SALARY
SURVEY
July 2015 QP 23
Passion
PROJECT
by Luke T. Foo
In 50 Words
Or Less
A small manufacturer,
DAddario, produces
world-recognized musical
strings with the help of
quality tools.
The organization provides
lean Six Sigma training
to every employee and
reinvests profits into
custom-made machines
to improve its processes.
Total quality management
and a philosophy of passion before profit fuel
DAddarios improvement
efforts.
Manufacturers
dedicated
employees,
TQM and quality
culture make
sweet musical strings
SMALL BUSINESS
A SMALL MANUFACTURER is producing guitar strings

for some of musics biggest stars, including Dave Matthews, Sheryl
Crow, Keith Urban, Gary Clarke Jr. and Lenny Kravitz. These artists creations and careers rely on the high-quality sound from their
guitar strings, and while they could choose strings from any manufacturer in the world, they use strings from DAddario and Co.,
located in Farmingdale, NY, a town with population of a little more
than 8,000 people.
The organizations history traces back to the 1600s when the
DAddario family began manufacturing strings from animal intestines in Salle, Italy. In 1905, two descendants moved to New York
after an earthquake rocked their village, and in 1918, the organization began manufacturing strings in a tiny garage in Astoria.1 Today,
DAddario exports to 120 countries, and its line of orchestral and
guitar strings is recognized as a world leader in many categories.
July 2015 QP 25
The role of strings
gold standard, having balanced tones, staying in tune
The four most significant attributes that contribute to a
and having a reasonable price.
stringed instruments quality of sound can be ranked as:
For any organization to produce high-quality prod-
1. The skill of the player.
ucts, it must employ quality methods in its manufactur-
2. The quality of the instrument.
ing. One definition of total quality management (TQM)
3. The quality of the bow (for orchestral stringed in-
is a people-focused management system that focuses on
struments).
continually increasing customer satisfaction at continu-
4. The quality of the strings.
ally lower costs. It works horizontally across functions
In todays world of million-dollar instruments, few
and departments, and it involves every employee.2
people would guess that stringswhich are relatively in-
TQM stresses learning and adapting to continual
expensiveplay such a significant role in sound quality.
change as keys to organizational success, and it includes
My interest in learning how DAddario was able to
systems, methods and tools.3 This perfectly describes
maintain its status as a world-class operation came from
the philosophy at DAddario. It was no surprise to learn
my personal avocations of music and musical instru-
that the personnel at DAddario live and breathe TQM,
ments. Ive been a quality professional for 20 years, but
and it was evident in my first few minutes of speaking
Ive played guitar for more than 40 years and recently
with the host management team.
started learning to play the violin.
The organization initially embarked on a lean Six Sig-
I was fortunate enough to be invited to DAddarios
ma journey about seven years ago, seeking a competitive
manufacturing and R&D facility for a rare peek into the
edge without employing the traditional cost-cutting tac-
world of string manufacturing. During my visit, I met
tics many organizations do. All of DAddarios employees
with members of the organizations management team:
are required to participate in lean Six Sigma training, and
Angela Zammit, marketing specialist; Fan-Chia Tao, di-
the degree of training depends on the employees level
rector of R&D; Brian Johnson, senior product specialist;
of responsibility. High-level management personnel are
Liz Crew, product specialist; and Dan Damon, process
expected to partake in more extensive training.
engineer.
In 2007, 12 management personnel were selected to

take a year and a half of training in lean Six Sigma. In
Quality manufacturing
addition to the required lean Six Sigma training for all
I participate in an online discussion board about guitars
employees, they also are encouraged to become more
where participants know the DAddario brand well for
versatile by cross training in other departments.
its quality. They describe DAddario strings as being the
Operators are empowered to make on-the-spot decisions on the manufacturing floor to prevent defects.
DEMINGS 14 POINTS
W. Edwards Deming provided 14 principles for improving an

organizations effectiveness.
1. Create a vision and
9. Optimize the efforts
demonstrate commitment.
of teams.
2. Learn the new philosophy.
10. Eliminate exhortations.
3. Understand inspection.
11. Eliminate numerical quotas
4. Stop making decisions based
and management by
on cost.
objectives.
5. Improve constantly and
12. Remove barriers to pride in
forever.
workmanship.
6. Institute training.
13. Encourage education and
7. Institute leadership.
self-improvement.
8. Drive out fear.
14. Take actions.
Every person understands how his or her actions affect

other departments further down the manufacturing line.
The organization convinced its suppliers to jump on
the quality bandwagon, working with them as partners
to meet its quality objectives. The management team
spoke with genuine and infectious enthusiasm about its
TQM practices, which include define, measure, analyze,
improve and control (DMAIC), 5S, principles from W. Edwards Demings 14 points and Joseph M. Jurans trilogy.
This isnt a passing fad, said Brian Johnson, a senior
product specialist. This is serious business. We continually look to improve product quality.
Reducing complaints with DMAIC

DAddario was receiving many customer complaints
SOURCE: The W. Edwards Deming Institute, Theories & Teachings,

www.deming.org/theman/theories/fourteenpoints.
about missing guitar strings. They are packaged with

six strings to a seteach string at a different gauge size.
SMALL BUSINESS
THE DADDARIO MANAGEMENT team from left to right:

Liz Crew, Angela Zammit, Brian Johnson, Dan Damon and
Fan-Chia Tao. (Photos courtesy of DAddario and Co.)
PART OF a seven-year development project, this custom-designed machine

creates nylon strings.
This process includes picking, coiling, placing and

packaging the strings.
The production line used a rotating belt with divider slots along the entire belt. Six operators sat next to
each other in a line in front of the belt. Each operator
was responsible for handling one gauge of string: He
or she picked it, coiled it and placed it in a slot on the
belt. As the belt moved, the next operator placed his or
her coiled string in the same slot. This was repeated by
six operators until the six different-sized strings filled
the same slot.
At the end of the line, the six strings were packaged
into a single plastic bag by a packaging operator, then
AN OPERATOR USES a string-winding machine.
boxed and shipped. Occasionally, an operator missed

filling a slot, so instead of packaging six strings to a
set, only five were packaged.4
Improve constantly and

forever
A DMAIC team was set up to identify the problem,
The two principal owners of the or-
determine a possible root cause, and implement cor-
ganization are brothers Jim and John
rective and preventive actions. Process mapping was
DAddario. Jim is chairman and CEO,
the primary tool used to identify the source of the
and John is vice chairman. Because the
problem.
organization is privately held and family
The solution was simple and effective: It reduced
owned, the brothers dont worry about
the number of operators on the line from six to three,
satisfying Wall Street and meeting quar-
and each operator was responsible for coiling and
terly earnings expectations. They say
placing two strings at a time into each slot. Visually, it
they owe their allegiance only to their
was easier to identify a missing pair of coiled strings
own
rather than a missing individual coil. Today, DAddario
and employees.
stakeholderstheir
customers
THE PRINCIPAL OWNERS of DAddario

and Co., John (left) and Jim DAddario.
says complaints have been reduced by several orders
They reinvest earnings into their employees and
of magnitude, and it also is closely following a number
manufacturing operations. If a piece of equipment is
of Demings 14 points (see the sidebar Demings 14
not commercially available, they custom build it them-
points, for the complete list).
selves. Many pieces of equipment on their production
July 2015 QP 27
SMALL BUSINESS
floor have been custom built, costing millions of dollars,
the ball is to help anchor the string to the saddle end of
and the organizations lean manufacturing largely relies
the stringed instrument.
on automation that helps save jobs.

DAddario invested heavily in automated equipment,
requiring it to hire additional personnel. After local poli-
The operators running these machines are empowered to perform self-inspection and stop production to
make impromptu adjustments.
ticians got wind of this, they encouraged the organization to continue growing its staff, and the township of
Quality trilogy
Babylonwhere Farmingdale is locatedand the state
The three principles of Jurans quality trilogy are:
of New York contributed funds to assist it in further ex-
1. Quality planningidentifying customer needs.
pansion of the factory to help employ additional staff.5
2. Quality controlmeasuring performance and
DAddario isnt afraid to experiment and invent, and

it makes some of worlds best nylon strings for classical
guitars. I learned that the development of those strings
took more than seven yearsand ongoing development
continues.
sources of variation.
3. Quality improvementmaking breakthrough
changes.
In one situation, DAddario implemented the quality
trilogy after customers had reported they experienced
The DAddario brothers have the patience to in-
string breakage. This occurs if excessive force is used to
vest additional time and effort on the development of
bend or stretch the strings when playing a bluesy note or
their strings to satisfy the challenging demands of their
using a whammy bar on an electric guitar.
customers and produce one of the worlds best nylon

strings, Johnson said.
DAddario solved the issue by inventing a new string

called NYXL, which has a proprietary high-carbon-steel
composition, giving it greater strength.6 In this example,
Vision and commitment
DAddario listened to the customer, experimented with
Jim DAddario is a musician, as are many of the organiza-
product and process improvements, monitored the
tions employees, but its not a prerequisite to be hired.
production process using state-of-the-art, in-line mea-
Musicians have a passion for the art of making music and
surement tools, and it permanently implemented these
the instruments. The prevailing philosophy at DAddario
breakthrough changes.
is passion before profit, which starts at the top of the

organization and trickles down to the every level.
This small organizations success stems from the

strong leadership exhibited by Jim DAddario and his
Fan-Chia Tao, director of R&D, said, Quality has to
management team, and their TQM philosophy that is
be driven from the top levels of management who set the
perfectly in tune with their passion for the art of making
culture by their actions.
beautiful music. QP
All the employees I spoke to exhibited a true passion

for quality, providing comments such as: Its a passion,
not a job, Its intensely positive here, and Our opinions matter.
These comments speak volumes about the organizations leadership. Showing that a positive environment
leads to long-term stability and job satisfaction, the average employees tenure is 16 years, and many employees
have been with the organization most of their adult lives.
A positive environment leads to long-term stability
and job satisfaction, said Liz Crew, product specialist.
Understand inspection
DAddarios main production floor has more than 100
string-winding machines with functions to attach a ball
at one end of the string and wrap another wire composed
of an alloy metal around the core wire. The function of
REFERENCES AND NOTES

1. Learn more about the history of DAddario and Co. by visiting http://tinyurl.
com/nyxlstory.
2. James R. Evans and William M. Lindsay, Managing for Quality and Performance
Excellence, eighth edition, Cengage Learning, 2010.
3. Ibid.
4. Watch a video on how orchestral strings are made at http://tinyurl.com/
daddariobowed.
5. DAddario & Company Moves Wire Mill to Farmingdale, NY, Creating Long
Island Jobs, Daddario.com, http://tinyurl.com/daddariojobs.
6. See the back story of DAddarios NYXL manufacturing process at www.
nyxlstory.com/story.
BIBLIOGRAPHY
DeFeo, Joseph A., and William W. Barnard, Juran Institutes Six Sigma Breakthrough and Beyond, McGraw-Hill Professional, 2003.
George, Michael L., David Rowlands, Mark Price and John Maxey, The Lean Six
Sigma Pocket Toolbook, McGraw-Hill, 2005.
LUKE T. FOO is the senior director of quality assurance
at Celsion Corp. in Lawrenceville, NJ. He holds a masters
degree in management systems analysis from Kean
University in Elizabeth, NJ. A senior ASQ member, Foo
is an ASQ-certified pharmaceutical good manufacturing
practices professional.
Whats Online in the

ASQ Knowledge Center?
CASE STUDY
Northrop Grumman Aerospace Systems
Global Supply Chain
This overview of the procurement approach of
Northrop Grumman Aerospace Systems details
how the global supply chain organization fosters
the production of quality products in an efficient
manner and in a collaborative environment.
QUALITY CLASSICS
The Quality Control Audit
In the January 1987 issue of Quality Progress,
Kaoru Ishikawa discusses how the quality
control audit is a broad concept with farreaching implications for organizations.
WEBCAST
Seven New Quality Tools: The Prioritization Matrix
Govind Ramu walks through how and when to use
the prioritization matrix, an L-shaped tool that can
help narrow down options through a step-by-step
approach applying selection of criteria, assigning
weights, and arriving at a conclusion through
basic mathematics.
Access this months featured content and more Web exclusives in the
ASQ Knowledge Center at asq.org/knowledge-center/featured.html.
TRAINING
CERTIFICATION
CONFERENCES
MEMBERSHIP
PUBLICATIONS
TM
Turning on
the Light Bulb
Critical reection needed
to get everyone to understand
and embrace quality
by John Robert Dew
In 50 Words
Or Less
For employees to embrace quality, managers

cannot simply introduce
and enforce quality
practices.
Managers must draw
everyone in the organization into an understanding of quality that
requires critical reection to embrace new
perspectives.
Reective practice
methods can help managers ip the switch in
employees minds and
help them understand
quality.
BEST PRACTICES
QUALITY PROFESSIONALS ARE often challenged to

help managers and employees embrace an understanding of quality
that is more about management principles, systems theory and the
broad concept of performance excellence; it goes far beyond
simply teaching someone how to use a specific quality tool. So,
how do quality managers help people turn the light bulb on when
it comes to embracing quality principles?
This type of educationthat transforms how people think
about quality and their understanding of their own organizations
requires critical reflection, which has been defined as a critique of
the presuppositions on which our beliefs have been built.1
July 2015 QP 31
Whether we are aware of it or not, each person de-
design and implement settings and experiences for
velops a set of meaning perspectives and takes actions
reflective learning that result in transforming perspec-
every day based on these perspectives. American soci-
tives about quality.
ologist Jack Mezirow described meaning perspectives
There are many examples of quality philosophies
as high-order theories, propositions and beliefs. They
that seek to generate perspective transformation that
are the ways someone interprets experiences and they
can be introduced through a reflective learning experi-
serve as the criteria for making value judgments. These
ence. While W. Edwards Deming devotedly taught the
meaning perspectives are acquired through cultural as-
control chart methods developed by his mentor, Walter
similation, but also may be intentionally learned.
Shewhart, the higher educational message he offered
While meaning perspectives are often learned in
was the concept he called profound knowledge, which
childhood, they also are strongly influenced by early
was a way to understand the world based on an under-
experiences in work settings and by the beliefs and
standing of how deeply variation influences everything
behaviors of the first supervisors and co-workers a
around us and how we must manage organizations ac-
person encounters. We learn to fit in with the cultural
cordingly.7
expectations of the organization in which we work.
Philip B. Crosbys concept that quality is free is
Over time, meaning perspectives reduce our anxiety
more than a short lesson about workplace econom-
by letting us dismiss unfamiliar experiences or ideas.
icsit offers a perspective transformation about the
The idea of meaning perspectives is the basis of the

comfortable and routine way of perceiving the world
hierarchy of the competing areas of quality, cost and

schedules in an organization.8
we refer to when we say we must get outside the box
Speaking as a former judge for the Malcolm Bal-
when seeking creative ideas. Staying inside this meta-
drige National Quality Award program, the Baldrige
phorical box is described as psychological inertia by
criteria are challenging to grasp because there are a
Genrikh S. Altshuller in the context of the theory of
variety of embedded meaning perspectives that create
inventive problem solving, or TRIZ, a method used by
a different world view that requires some reflective
many quality professionals.3
learning to appreciate.
Reflective learning
create perspective transformation also challenges a
Learning often requires new interpretations and new
quality manager to address the issue of reification in
comparisons that will either reinforce our comfortable
the workplace. Reification is the false belief that the
meaning perspectives or create new ways of seeing
circumstances around us that have been created by
the world. Reflective learning is a way of describing
people cannot be changed by people.9
Designing a reflective practice activity intended to
activities in which individuals engage to explore their

experiences to lead to new understandings.4
English mathematician and philosopher Alfred

North Whitehead referred to reification as the fallacy
One of the earliest concepts of reflective learning
of misplaced concreteness, or thinking our work-
was advanced by John Dewey, who referred to it as
places and social systems are concrete and cannot
assessing the grounds of ones beliefs. This is not
be changed.10 Many quality managers already know
about training people on how to use a specific method,
reification can run deep in an organization, and that
but rather setting the stage for people to discover and
this false belief that an organization cannot change
embrace a new way of understanding what is actually
and that change should not even be attemptedis the
happening in the world around them.
cause of many quality problems.
What is often needed for people to see the workplace experience in a new way is a reflective learning
Reflective learning methods
process that results in what the Brazilian educator
Reflective learning is not at all like a training class
Paulo Friere called perspective transformation, which
where people learn how to construct a control chart
is what we often mean when we say the light bulb
or develop an audit plan. There are at least seven prov-
comes on.6 It is the aha moment in which we see what
en methods of reflective learning that quality manag-
may be familiar from a whole new perspective.
ers can deploy in the workplace to achieve a perspec-
So, the challenge for the quality professional is to
tive transformation about quality:
BEST PRACTICES
Reification is the false belief that the

circumstances around us that have been created
by people cannot be changed by people.
1. Group discussion around structured ques-
challenge perspectives.
tionsThis approach is based on the theory and ex-
3. Critical incidents discussionEducator Ste-
tensive practice of American educator Myles Horton,
phen Brookfield has advanced the practice of using
who noted the best way to help change perspective is
real-world circumstances among peer learners to ex-
not to tell people the answers to their problems but to
amine their assumptions about many facets of life.13
get people together and to start talking.
11
In the workplace, co-workers can be assembled to
This approach may be uncomfortable for some peo-
review information about a critical incident. This could
ple because they are not accustomed to listening and
be the loss of an important customer, a quality failure
only know how to talk. The leader brings a group of
in production, a sentinel event in a healthcare setting,
people together in a comfortable setting and guides the
an industrial accident or an environmental mishap. A
group through a structured series of questions.
facilitator asks the participants to identify the operat-
The topic can be about a specific article that everyone in the group has been asked to read. It can be
ing assumptions that were in place that enabled things

to go amiss.
about the results of an environmental scanning exer-
The purpose is not to identify who is at fault, but to
cise (strengths, weaknesses, opportunities and threats
understand what people thought should be happening,
analysis, for example) from a strategic planning ses-
what they thought was actually happening and wheth-
sion, or an opportunity for a group to review the feed-
er anyone realized a problem was developing.
back from a customer or employee survey. The goal
4. Case study discussionsMost readers who
is to encourage participants to think critically and to
have participated in a graduate seminar in manage-
openly share their thoughts.
ment recognize the case study as a popular method
2. Metaphor analysisThe use of organization-
for reflective learning. Everyone who will participate
domain metaphor analysis brings a group of people
in the discussion reads the same case study, and a fa-
from a common organizationwith a common set of
cilitator guides the discussion to bring out important
experiencestogether to examine their organization
points about meaning perspectives and meaning trans-
from the perspective of a metaphor.
formations.
David Deshler has suggested asking groups to think
Harvard Business Review provides many excellent
about their organization as if it were a machine, a fam-
articles that can be used as case studies, along with
ily, a Monopoly game or the military.12 Its also had suc-
numerous examples published in graduate-level text-
cess in a variety of work settings with the use of sports
books on operations management.
as a metaphor to stimulate reflective learning.
Likewise, Crosby, Deming and Joseph M. Juran in-
Manufacturing organizations often relate well to a
cluded interesting examples in their major works that
conversation about how a factory is similar to a foot-
can be used as case studies in workshops. The goal of
ball game. Office groups can relate to a fast-paced team
a case study is not to show how ignorant another or-
sport such as basketball. Individuals with similar func-
ganization was, but to stimulate discussion about the
tions who are spread across a company, such as pur-
assumptions being made in that organization and how
chasing managers and public relations managers, can
close those assumptions are to the participants orga-
reflect on their organization as if it were a game of golf.
nization when it comes to issues pertaining to quality.
In each of these cases, employees are encouraged
5. Art exercisesLeah Burns has provided many
to discuss the organization from the perspective of the
examples of how art can serve as a vehicle for dialogue
metaphor, leading to interesting revelations that will
and exploration regarding dominant meaning perspec-
July 2015 QP 33
BEST PRACTICES
tives in a community. This method can also be effective
deploying propulsion units and fuel for nuclear sub-
in a work setting.14
marines. These methods later came to be embraced
A basic exercise that can generate a surprising level
at nuclear power generation stations and in all stages
of critical examination regarding the nature of an orga-
of the nuclear fuel cycle before being adopted by the
nization is to ask a group of supervisors, team leaders
manufacturing and healthcare sectors.
or a quality departments staff to work in small groups
Regardless of the specific method employed
of four or five peopleeach group working indepen-
questioning to the void (a systematic way of asking
dently on an easel to draw a picture that interprets
questions), event and cause-factor analysis, barrier
their organization.
analysis, fault-tree analysis and other optionsthe
Each small group is asked to share its drawing with
objective is to stimulate critical thinking about a work
the larger group and explain why the group described
setting that will create new understanding and mean-
the organization in the way it did. This process can
ing perspectives.
bring out the unstated beliefs that are shared in an organization that may not be at all consistent with the
Critical reflection
organizations stated policies and practices.
To be effective, quality managers cannot simply in-
My favorite example is a group of supervisors who
troduce and enforce quality practices, but must draw
drew its workgroup as a line of ants marching toward
everyone in the organization into an understanding of
a distant mountain while a cloud labeled as manage-
quality that requires critical reflection to embrace new
ment rained down on them. This drawing crystalized
perspectives. Through reflective practice methods,
the unspoken shared perspectives in the workplace
quality managers can help flip the switch and turn on
and led to more open discussion about the trust and
the light bulb to quality. QP
communication between upper management and team

leaders.
6. Force field analysisThe field of systems
thinking was significantly influenced by the German
social scientist Kurt Lewin who invented force field
analysis.15 As a form of reflective learning, force field
analysis compels people to examine an organization
from a broader systems perspective by identifying a
specific objective to be accomplishedor a change to
be made. They do this by identifying the internal and
external forces that will support the change, and the
internal and external forces that will resist the change.
This process helps people reflect on how the status
quo is maintained by a balance of forces known as homeostasis.
To create change, participants must identify how to
upset the balance through a combination of strength-
REFERENCES
1. Jack Mezirow, Fostering Critical Reflection in Adulthood, Jossey-Bass, 1990.
2. Ibid.
3. Genrikh S. Altshuller, Creativity as an Exact Science, Gordon and Breach,
1984.
4. David Boud, Rosemary Keogh, David Walker and Kogan Page, eds., Reflection: Turning Experiences Into Learning, Routledge & Kegan Paul, 1985.
5. John Dewey, How We Think, Prometheus Books, 1991.
6. Paulo Freire, The Politics of Education, Bergin & Garvey Publishers, 1985.
7. W. Edwards Deming, Quality, Productivity and Competitive Position, MIT
Press, 1982.
8. Philip B. Crosby, Quality Is Free, New American Library, 1979.
9. Freire, The Politics of Education, see reference 6.
10. Alfred North Whitehead, Process and Reality, Macmillan Co., 1929.
11. Myles Horton, The Myles Horton Reader, University of Tennessee Press,
2003.
12. David Deshler, Metaphor Analysis: Exorcising Social Ghosts, which
appeared in Jack Mezirow, ed., Fostering Critical Reflection in Adulthood,
Jossey-Bass, 1990.
13. Stephen Brookfield, Developing Critical Thinkers, Jossey-Bass, 1987.
14. Leah Burns, Seriously Are You Really an Artist? Humour and Integrity
in a Community Mural Project, which appeared in Deborah Barndt, ed.,
Wild Fire: Art as Activism, Sumach Press, 2006.
15. Kurt Lewin, Field Theory in Social Sciences, Harper & Brothers, 1951.
16. Hyman Rickover, Education and Freedom, E.P. Dutton and Co., 1959.
ening the supporting forces and weakening the resisting forces. The process of this discussion can result in
significant perspective transformations.
7. Root cause analysisAs a method, root cause
analysis has its origins in the U.S. Navys nuclear program, with the insistent expectation for questioning
everything that was the hallmark of Admiral Hyman
Rickovers leadership style.16
Most root cause analysis methods were developed
by engineers and officers engaged in designing and
JOHN ROBERT DEW is the senior vice chancellor at

Troy University in Alabama. Prior to joining Troy University in 2007, he was director of continuous quality improvement and planning at the University of Alabama
for nine years, where he established the graduate
program in consumer quality management. Before
entering academe, Dew spent 23 years as a quality
professional with Lockheed Martin Corp. He earned a
doctorate in education at the University of Tennessee in Knoxville. Dew is an
ASQ fellow, a member of the International Academy for Quality, past chair of
ASQs Education and Training Board, past chair of the ASQ Energy and Environmental Division, and past chair of ASQs Education Division. He has served
as a judge for the Malcolm Baldrige National Quality Award Program.
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TRAINING
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TM
Whats YOUR
Theory?
Driver diagram serves as tool
for building and testing
theories for improvement
by Brandon Bennett and Lloyd Provost
In 50 Words
Or Less
A driver diagram is
an applicable tool for
many contexts, from
improving process
reliability to redesigning
a service to creating
new products to
generating enhanced
user experience.
The tool visually
represents a shared
theory of how things
might be better, building
upon knowledge
gleaned from research,
observation and
experience.
At least it appears that we must accept a kind of double

truth: There are certainties, such as those of mathematics,
which concern directly what is only abstract; and there
are the presentations of our sense-experience to which we
seek to apply them, but with a resultant empirical truth
which may be no more than probable. The nature and
validity of such empirical knowledge becomes the crucial
issue.
C.I. Lewis1
IN THE NEW ECONOMICS, W. Edwards Deming articulated a view from outside that he believed was a
high-level complement to subject matter expertise in the pursuit of improvementhis system of profound knowledge.2
Deming outlined four elementsappreciation of the system,
understanding variation, psychology and the theory of knowledgewhich provide insight into how improvement can occur.
July 2015 QP 37
Completed driver diagram

Aim
Primary
drivers
Secondary
drivers
/ FIGURE 1
Specific change ideas
Use assessment of risk tool to identify
patients and other factors that may
influence patient populations
Patient
identification
Provide 90%
of high-risk
adult and
surgical
patients with
a medication
management
service at
discharge
and in the
immediate
postdischarge
period
(7days)
High-risk
patient
discharge
process
Discharge
planning
processes
Notification processmagnets
on patients boards (enroll
patients), pharmacist
Identify patients at greatest

risk of harm and greatest
potential for benefits
Synchronize
Collaboration
Referral mechanism
Medication
process
Integration
and
coordination
of services
with primary
care
Pharmacist
resource
Modify electronic discharge

summary (EDS) template to
identify high-risk patients
Change concepts
Training
resources
Recruitment
Accuracy of medication: medication

reconciliation on discharge medication
review/EDS medication review
Access to medication: fax script,
access/transport, test safety if picked
up. Identify barriers to access
Resource pack: medication
card, patient information leaflet,
checklist, compliance aid
Follow up with patient after discharge
Focus on core process

and purpose
Focus on the outcome

to the customer
Conduct training
Follow up significant issues

with primary care physician/
community pharmacy
Use standard operating

procedures
Medication reconciliation, medicines

use review training
Create a formal process
Use checklist as prompt and

to collect information
Specific pharmacists
dedicated to service
Invest more resources

in improvement
For most practitioners of improvement, apprecia-
of what theory and ideas are empirically relevant for
tion of the system, understanding variation and psy-
managing and improving the system of interest.3, 4 In
chology of change are natural foundations for their
a practical context, this knowledge is best articulated
work, with known applicable tools and plenty of case
as a testable prediction of the activities and infrastruc-
examples in which the impact of each was important in
ture necessary to achieve a desired outcome.
achieving some organizational aim.
Knowledge becomes useful when partnered with a
Except for the widespread use of the plan-do-
method for testing and learning its validity in practice.
study-act cycle (PDSA), the theory of knowledge
For years, the PDSA cycle has been a practical method
has been applied and written about much less often.
for applying the scientific method in an operational
Instead, those tasked with improvement often move
space. Today, the model for improvement (MFI) has
forward solely from the perspective of subject matter
emerged as a key learning method, incorporating the
knowledge or with unexamined assumptions about
PDSA cycle and three questions to focus improvement
their system.
efforts:
A theory of knowledge can be defined as a view
1. Aim: What are you trying to accomplish?
2. Measurement: How will you know a change is an
driver diagram. Figure 2 shows a generic format that

will be the focus of this article.
improvement?
3. Theory of improvement: What changes can you
make that will result in an improvement?5
Key leverage points
A driver diagram serves as a tool for building the
The primary and secondary drivers from which the
testable hypothesis.6 It consists of a teams shared
tool derives its name are intended to identify the ele-
theory of knowledgewhich is developed by consen-
ments in the system that are necessary and sufficient
susand includes relevant beliefs of team members
for achieving the intended outcome.
about what must change and which ideas about how
They include three elements: structures that com-
to change may result in improved outcomes. Figure 1
prise the system, processes that represent the work
shows an example of a completed driver diagram for a
of the system and operating norms that demonstrate
healthcare improvement project.
the explicit and tacit culture of the system.10 These are
For an improvement project, the driver diagram
typically theorized by working closely with subject
illustrates what structures, processes and norms are
matter experts who work directly with the system of
believed to require change in the system as well as
interest.
how these could be changed through the application
Structures may include the physical design of a
of specific ideas. This tool has been applied to varied
space or product, technological elements (such as
contexts, from the improvement of a single process to
equipment), the overarching architecture of software,
the redesign of an existing service to the creation of
departments and other groupings in an organization
new products aimed at enhancing user experience.8, 9
and organizational policies. Management systems,

such as financial, administrative, improvement and
Setting up an improvement project
leadership structures, are also often included.
The intended outcome of an improvement project is
Processes refer to the systems workflow: how
articulated in the form of an aim statement, which typi-
things are accomplished, what steps are taken and
cally outlines the following:

Outcomes of the system desired to
be improved.
The intended magnitude of the improvementwith a direct link to an
outcome measurement of interest.
Conceptual view of a driver

diagram/FIGURE 2
Outcome
A timeframe for completion.
Primary
drivers
On a driver diagram, everything to the

right of the aim statement identifies a
Primary
driver 1
theory about what must change and how

it must change to achieve the desired
Secondary
drivers
Secondary
driver 1
Secondary
driver 2
performance or outcome. Because the

driver diagram represents an overall theory, it is essentially a broad prediction
of the changes required to accomplish a
Aim or
outcome
Primary
driver 2
Secondary
driver 3
given aim or outcome.

A driver diagram is often used because the evidence about how to accomplish the aim is not well established in
the system of interest. The driver diagram is, therefore, best used as a tool for
initiating or accelerating learning in an
improvement project.
There are a variety of formats for a
Primary
driver 3
Secondary
driver 4
Secondary
driver 5
Key leverage points

in the system
Specific changeideas
Ideas:
1
2
3
4
5
6
7
8
9
Change
concepts
Concept 1
Concept 2
Concept 3
Concept 4
Concept 5
Concept 6
Specific ideas, concepts

and bundles that could
generate the desired state
July 2015 QP 39
in what order. In some organizations, processes are
when introducing new ways of doing things, whether it
named and most employees know which processes
is replacing a tool, introducing a new step, reordering
they work in and for which steps they are responsible.
a sequence of events or maintaining a beneficial behav-
Note that these are often where the greatest improve-
ior. These second-level items can be thought of as the
ments can be made given existing resource constraints.
switches within the system that must be flipped on or
In other organizations, processes are vaguer concepts
off to achieve the outcome of interest.
that must be studied and mapped to be improved.
For some improvement efforts, moving from the
Operating norms include written and unwritten
primary to the secondary level with drivers is unneces-
rules that govern the behavior of members of the sys-
sary because the aim may be to improve a single pro-
tem. These norms reflect the organizational psychol-
cess or step within a micro system. In these cases, it
ogy of the system and are, therefore, critical elements
may be best to omit secondary drivers.
when considering the introduction of change to any
Conversely, there may be times when the theory

being developed is quite complex, which would re-
status quo.
The primary drivers are high-level elements in the
quire the addition of a third level in the driver dia-
system that must change to accomplish the outcome
gram. This adaptation is not recommended for practi-
of interest. Nested below them are secondary driv-
cal reasons: The diagram is intended as a clear and
ers, which are more actionable approaches, places or
simple visual depiction of theory, so if it includes too
opportunities within the system where a change can
many drivers or associated changes, its utility may be
occur. An overarching process is identified at the pri-
compromised.
mary level, for example, and individual steps within

that process are outlined at the secondary level.
In such circumstances, teams may instead make

multiple driver diagrams, each with only primary and
The secondary level articulates the physical places,
secondary drivers. Each respective diagram will be
time-bound moments and norms that can be acted on
more useful to teams tasked with testing change ideas.
Driver diagram informs testing, testing refines theory/FIGURE 3

Outcome
Primary
drivers
Primary
driver 1
Secondary
drivers
Secondary
driver 1
Secondary
driver 2
Aim or
outcome
Primary
driver 2
Primary
driver 3
Secondary
driver 3
Secondary
driver 4
Secondary
driver 5
Key leverage points

in the system
Specific changeideas
Ideas:
1
2
3
4
5
6
7
8
9
Change
concepts
Concept 1
Concept 2
Model for improvement

What are we trying
to accomplish?
How will we know a
change is an improvement?
What change can we make
that will result in improvement?
Concept 3
Concept 4
Concept 5
Concept 6
Specific ideas, concepts

and bundles that could
generate the desired state
Act
Plan
Study
Do
In some organizations, processes are named

and most employees know which processes
they work in.
If and when there is a need to communicate the over-
manifest through a variety of specific change ideas.
all improvement effort, these nested driver diagrams
An improvement effort focused on increasing the
can be aggregated into a parent diagram that indicates
reliability of process Y, for example, might theorize
where more detail can be found.
that setting an ongoing calendar remindera specific

change ideawill improve reliability in execution of
Specific ideas and concepts
the process by X%, but when tested, the calendar re-
The next section of the driver diagram has the specific
minder might fail to deliver the intended outcomes.
focus of listing all of the actionable changes that can
In this case, the change idea did not result in im-
be tested on the system of interest to accomplish the
proved performance. As the team considers the under-
stated aim. It consists of two parts: change ideas and
lying concept (reminders), however, it might formu-
change concepts.
late other types of reminders (other specific change
Change ideas are tangible and specific. They ar-
ideas) that might work. Other change ideas could be:
ticulate how a tangible and specific change is intended
automatically send a text message at the appropriate
to take place in a system. The statement implement
time, call someone who initiates process Y or send an
assessment X for condition A is too vague, for ex-
email.
ample, because it misses how the implementation will

actually occur.
If none of these work, the team may consider revising its theory to reflect the learning that reminders
While the underlying theory might be, If the system
of all types do not provide the intended effect before
can reliably assess X, action can be taken to create an
moving to other concepts and associated change ideas
efficacious plan to address the risk of condition A, it
that might prove more useful in achieving the outcome
still lacks clarity on how to perform and complete the
of interest.11
assessment.
In some circumstances, teams will develop driv-
The change idea must incorporate more detail, such
er diagrams that include change ideas with strong
as a description of a newly designed process that will
empirical evidence to support the ideas efficacy. In
allow the system to reliably complete the assessment
these situations, it would not make sense to include
of a given tool. It may be appropriate to include an ap-
ideas associated with change concepts, which ulti-
pendix link to a process map or flow diagram that can
mately serve the purpose of helping to identify an
be tested, refined and, ultimately, made a permanent
ever-increasing number of change ideas which might
part of business as usual.
be experimented with in the system.
Note that there may not be a one-to-one relationship
Another approach would be to use the space where
between change ideas and the drivers the ideas might
a change concept would normally sit to create a direct
affect. The complex nature of many systems means
link to the reference materials for the evidence indicat-
a single idea may affect multiple drivers. Conversely,
ing the efficacy of or need for the change idea being
many ideas may work together to affect one or more
included on the diagram.
drivers. These interactions can be captured in the diagram and subsequently tested as bundles of change
Partnering a mechanism, driver diagram
ideas.
Deming wrote:
Change concepts represent abstract forms that

underlie change ideas. They can enhance the improve-
The theory of knowledge teaches us that a statement, if it
ment journey by reflecting an abstract form that can
conveys knowledge, predicts future outcome, with risk of
July 2015 QP 41
being wrong, and that it fits without failure observations

of the past. Rational prediction requires theory and builds
diagram to illustrate a theory in a purely conceptual way.

Other measurements designed to illustrate the voice
knowledge through systematic revision and extension of
of the system can be linked directly to the primary and
theory based on comparison of prediction with observation.12
secondary drivers. These can include specific process

measurements, financial measurements, or measure-
A driver diagram is most useful when it depicts a
ments of staff and client satisfaction. Some teams will
theory that can be tested empirically. Without learn-
place these measurements directly on the driver dia-
ing through testing and continual revision, a driver
gram as an annotation, while others might choose to
diagram becomes just an interesting picture or, at
develop a comprehensive measurement strategy in a
best, it simply represents an unproven implementa-
separate document.
tion plan.
To maximize its effectiveness, a driver diagram
must be partnered with a mechanism for learning. The
Figure 4 provides a simple example of the iteration

that takes place when a theory of improvement is tested and refined using the PDSA cycle.
MFI, which includes PDSA cycles, is one such tool for

this partnership.13
Informing improvement
PDSA cycles can be used iteratively on individual
The use of a driver diagram by improvement teams rec-
change ideas or to organize orchestrated testing of sev-
ognizes change is required to improve a system, and
eral ideas through planned experimentation. The aim
theory is used to articulate the knowledge about how
always being to learn whether the overall theory artic-
to achieve an aim of interest.
ulated by the driver diagram can generate the quality

improvement desired.
Improvement takes place in dynamic environments

where barriers, resources, cultures and attitudes are
When change ideas fail to achieve the impact pre-
often in flux and are therefore unpredictable. As such,
dicted by the diagram, either the leverage points iden-
the tool presents the best information and most in-
tified or the specific ideas articulated (or both) can be
formed beliefs a system has about why things are the
updated to reflect the learning derived from these it-
way they are right now, and how they might be im-
erative test cycles (see Figure 3, p. 40).14
proved.
The aim of bringing together the MFI and the
After being visualized, the tool can and should
driver diagram is to discover knowledge that is use-
be used to refine knowledge of a system as learning
ful for achieving ever better outcomes from a system.
takes place. QP
Through this process of prediction, testing, learning

and revision, a system can continuously evolve toward
the aim of any improvement project.
In healthcare, this might mean continuous learn-
EDITORS NOTE
The authors thank Tom Nolan for his original work in the creation of this
tool. They also recognize Cincinnati Childrens Hospital, where the driver
diagram was first used and has become a standard part of its improvement
framework.
ing about how to improve the health of a local population. In education, it could mean learning the best
REFERENCES AND NOTES
ways of increasing teacher effectiveness. In software
1. C.I. Lewis, Mind and the World Order: Outline of a Theory of Knowledge,
Dover Publications, 1929.
2. W. Edwards Deming, The New Economics for Industry, Government, Education, second edition, MIT Press, 1994.
3. Lewis, Mind and the World Order, see reference 1.
4. Deming, The New Economics for Industry, Government, Education, see
reference 2.
5. Gerald J. Langley, Ronald Moen, Kevin M. Nolan, Thomas W. Nolan, Clifford
L. Norman and Lloyd P. Provost, The Improvement Guide: A Practical Approach to Enhancing Organizational Performance, Jossey-Bass, 2009.
6. Ibid.
7. Ko Awatea, Safer Medication Outcomes on Discharge Home Collaborative, Health System Improvement Guide, The 20,000 Days Campaign 2014,
www.koawatea.co.nz.
8. Anthony S. Bryk, David Yeager, Jane Muhich, Hannah Hausman and Lawrence Morales, Practical Measurement, www.carnegiefoundation.org/
resources/publications/practical-measurement.
9. Theodore Svoronos and Kedar S. Mate, Evaluating Large-Scale Health
Programs at a District Level in Resource-Limited Countries, Bulletin of the
World Health Organization, Vol. 89, No. 11, pp. 831-837.
10. Langley, The Improvement Guide, see reference 5.
development, it could simply mean learning how to

quickly respond to the ever-more-fickle demands of
clients and users.
A driver diagram also can help craft the measurement strategy of an improvement initiative. One of the
three core questions of the MFI is, How will you know
a change is an improvement? This can be easily linked
to the primary and secondary drivers and to the aim
statement.
Outcome measurements should be embedded in the
aim statement for most driver diagrams, though this may
vary if a team is building nested diagrams or using the
Iterative refinement of a theory of improvement

using a driver diagram and PDSA/FIGURE 4
Initial theory of improvement
Aim: A more effective morning
management meeting.
Reduce time of meeting from
120minutes to 90 minutes.
Revised theory of improvement
Group norms
Meetingprocess
Act
Plan
Study
Do
Group norms

management meeting.
120 minutes to 90 minutes.
Final theory of improvement
Meetingprocess
Act
Plan
Study
Do
Group norms

management meeting.
120 minutes to 90 minutes.
Meetingprocess
11. A useful list of 72 change concepts for this purpose has been published
in The Improvement Guide: A Practical Approach to Enhancing Organizational Performance, see reference 5. While improvement teams might
like to leverage this list at times, the concepts underlying specific change
ideas may be apparent and can be identified simply through group
discussion.
12. Deming, The New Economics for Industry, Government, Education, see
reference 2.
13. Langley, The Improvement Guide, see reference 5.
14. For more detail on how this is accomplished, read Langley, The Improvement Guide, see reference 5.
BIBLIOGRAPHY
Bryk, Anthony S., Louis Gomez and Alicia Grunow, Getting Ideas into Action:
Building Networked Improvement Communities in Education, Frontiers in
Sociology of Education, Spring 2011.
Change ideas:
1)
voting
1. Make decisions by voting.
2)
2. Have the owner be more of
meeting
a dictator during meeting.
Change ideas:
3)
Prepare and
and use
use an
anagenda.
agenda
3. Prepare
4)
issues
4. Limit the number of issues.
5)
5. Give assignments to
meeting
prepare for the meeting.
Change ideas:
2. Have the owner be more of
a dictator during meeting.
Change ideas:
3. Prepare and use an agenda.
4. Limit the number of issues.
Change ideas:
Change ideas:
2. Prepare and use an agenda.
BRANDON BENNETT is an improvement advisor at

Improvement Science Consulting in Washington,
D.C., and a fellow at the Carnegie Foundation for the
Advancement of Teaching. He has a masters degree in
public health from Loma Linda University in California.
Bennett is an ASQ member.
LLOYD PROVOST is an improvement advisor at Associates in Process Improvement in Austin, TX, and a
senior fellow at the Institute of Healthcare Improvement. Lloyd has a masters degree in statistics from
the University of Florida in Gainesville. He is a senior
member of ASQ and received the ASQ Deming Medal
in 2003.
July 2015 QP 43
MEASURE FOR MEASURE
BY DILIP SHAH
Estimating Uncertainty
Metrological traceability to non-SI units
IN THE March and May 2015 Measure
Measurement process
/ FIGURE 1
for Measure columns,1, 2 there was a

discussion on measurement challenges
Uncertainty analysis
(traceable to SI units)
and how to report measurements with

a degree of confidence by reporting
measurement uncertainty to support
metrological traceability.
Input 1 (unit A)
Typical contributors:
Repeatability
Reproducibility
Sample variability
Resolution
Traceability
of unit A
Estimating measurement uncertainty

for calibration laboratories can still be
a significant effort to support metrological traceability. However, most of the
calibration laboratory parameters are
common and traceable to the International System of Units measurements,
Input 2 (unit B)
Traceability
of unit B
Test/
calibration
measurement
process
Single output
result (unit D)
commonly referred to as SI units, after

the concepts for estimation are grasped.
Not traceable
to SI units
For certain test and calibration

disciplines, the documented unbroken
chain may not be directly traceable to
SI units. This may be because there is
more than one input to the test method,
Participation in a
suitable interlaboratory
comparison program
Input n (unit C)
Traceability
of unit C
and the output is a different unit from

that of the inputs, which are expressed
end result can be quantified by traditional
in units not traceable to SI units. Figure 1
uncertainty estimation means (traceable
illustrates this measurement process.
to SI Units), the problem may not be as
There are more combinations for test

laboratories for estimating uncertainty
If the traditional estimation methods
than for calibration laboratories. There-
cannot be deployed, the lab may need to
fore, the test laboratories face other chal-
participate in a proficiency test or an inter-
lenges because they may not have all the
laboratory comparison program to claim
output test parameters that are directly
the metrological traceability (for measure-
traceable to an SI unit.
ment not directly traceable to SI units).
Take, for example, a pharmaceutical

organization that mixes the recipe for a
medication. It may mix the ingredients
difficult.
This requirement is identified in ISO/IEC

17025 Section 5.6.2.1.2.3
When there are many different units
for the recipe by weight or volume. While
of measurement, the uncertainty con-
weight and volume are metrologically
tributors may be expressed in a unit-less
traceable, the end result may not be. The
quantity, such a percentage or parts per
end result may be a qualitative or quan-
million. The output result is expressed in
titative measure in a different unit. If the
the same unit-less quantity.
In chemical metrology, there is
face the new measurement challenges.
tributors can be expressed mathemati-
another technique called the Kragten
Nanotechnology is here, and measure-
cally to the output result, the repeatability
spreadsheet approach, which can be
ments on a small scale require better tools
of several simulations with the resultant
used to estimate the uncertainty. The
with more precision and accuracy. QP
output quantity can be used to estimate
Kragten spreadsheet can be used to
uncertainty. The uncertainty estimation of
simplify the calculations of partial differ-
torque is a good example.
entials. The procedure takes advantage
If a relationship to the uncertainty con-
Torque is defined as distance x force. If
of an approximate numerical method of
the distance is defined in meters and the
differentiation and only requires knowl-
force is defined in Newtons, the resul-
edge of the calculation used to derive
tant torque is in Newton.meters (N.m).
the final result (including any necessary
Therefore, the uncertainty of torque can
correction factors or influences) and of
be quantified by repeatability of several
the numerical values of the parameters
random simulations of
and their uncertainties. A future Measure
distance (+/- distanceuncertainty) x force
for Measure column will describe and

provide an example of using the Kragten
(+/- forceuncertainty).
spreadsheet method.
In this case, all quantities, including

the output, are traceable to SI units. How-
Making and reporting a measurement
ever, the technique can be used for non-SI
with its associated measurement uncer-
unit output quantities.
tainty becomes more important as you
REFERENCES
1. Dilip Shah, Measuring Device Revolution, Quality Progress, March 2015, pp. 46-47.
2. Dilip Shah, Measuring Confidence, Quality Progress,
May 2015, pp. 46-48.
3. International Organization for Standardization and International Electrotechnical Commission, ISO/IEC 17025
General requirements for the competence of testing and
calibration laboratories, Section 5.6.2.1.2.
DILIP SHAH is president of E = mc3

Solutions in Medina, OH. He is the
past chair of ASQs Measurement
Quality Division and past chair of
Akron-Canton Section. Shah, an ASQ
fellow, is also co-author of The Metrology Handbook (ASQ Quality Press,
2012), and an ASQ-certified quality
engineer, auditor and calibration technician.
Visit
asq.org/qualitytools
to learn more.
PDSA plus QToolsTM

is your go-to resource.
Incorporate plan-do-study-act (PDSA) and the seven different quality tools to
improve your processes, resulting in higher productivity and overall greater profit.
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July 2015 QP 45
QUALITY IN THE FIRST PERSON
BY T. DAN NELSON
Substandard Information
ISO 9001 misunderstandings cause negative first impressions

I FIRST HEARD about the ISO 9001 standard as a graduate student at the University of Iowa. It was lumped in with other
acronym-ridden quality initiatives, such as
just-in-time (JIT) delivery and total quality
management (TQM). I didnt pay close
attention to ISO 9001, not having any idea
how familiar Id become with it in the
years to come.
After finishing graduate school, I
moved to Colorado. In 1994, I began my
career with ISO 9001 after a small circuit
board shop hired me to write its work
instructions. The organization was in pursuit of ISO 9002 certification and needed
to document its quality management
system (QMS).
Training was a week-long whirlwind
confusing at best. But the shop passed the
that left me with more questions after-
registration audit with flying colors. After
technical writer to develop lower-level
ward than I had going in, but I passed the
it was certified and the party was over, my
work instructions. The quality manager
final exam with no problems. I thought I
job was finished, and it was time for me to
was already working on customizing
understood the training as well as anyone
find another one. The taste of ISO 9001 in
prewritten system-level procedures hed
else and that working for a certifying body
my mouth had gone from bad to worse.
found in a popular book. If only I knew
would augment the training provided.
I was hired as a temporary, full-time
Again, as I looked for work, the best
Much of the course focused on the
job I found wasyou guessed itwriting
individual requirements of ISO 9001, and
documentation for a company in pursuit
Miseducation
it left me thinking that organizations docu-
of ISO 9001 certification, and I was hired
A year and a half later, I completed the
mented their QMSs merely to pass ISO
on a contract basis. After several months
work instructions and left the circuit
9001 audits. Years later, I would under-
of writing lower-level QMS documentation
board shop with a bad taste of ISO 9001
stand that passing audits is a secondary
and being able to show a few years of ISO
in my mouth. But the best job I could get
objective of QMS documentation.
9001 experience, I found full-time work as
then what I know now.
wasyou guessed itwriting work in-
Most of the principles of quality man-
a consultant trainee.
structions for another company in pursuit
agement contained in ISO 9000from
of ISO 9001 certification. I did that for a
which the requirements of ISO 9001 are
few months before I was called back to
derivedare straightforward and dont
Process vs. standard-based

approach
the circuit board shop.
require strenuous training. The process
My newest employer was a small British
approach, however, was a principle
consulting firm. Not only was I trained
leaving the organization, so I was asked
contained in ISO 9000 that did require
to be a management consultant, I also
to help the shop become certified, and I
further explanation for many lead auditor
learned what ISO 9001 was really about.
obliged. Following the advice of my boss
trainees, but just like the principles, it was
The basic lesson of my training was that
before his departure, I requested the orga-
only briefly addressed.
procedures were supposed to describe
The quality manager announced he was
nization send me to ISO 9001 lead auditor

training.
Nobody at the shop liked the ISO 9001

procedures that were created. They were
actual organizational processesnot the

standards clauses and subclauses.
Until that time, I thought ISO 9001

required 20 procedures. Thats what my
pends on the number of processes defined
the standard, of course.

I discovered, like many people, I was
as being needed for the system to func-
books said, and thats what everyone else
viewing ISO 9001 incorrectly. Unlike my
tion. Some systems are properly defined
was doing. It wasnt even a question.
previous training courses, my new em-
by 10 procedures, others by 30. Thats a
ployers set me straight.
feature of the process approach. Docu-
After the release of ISO 9001:2000,

there was a problem with the books avail-
ISO 9001 never required a certain
mentation is focused on processespur-
able for guidance on the standard. None
number of procedures. The approach
suant to plan-do-check-act cyclesrather
of them appeared to explain the process
promoted by popular books and my previ-
than being focused on clauses of ISO 9001.
approach promoted by ISO 9001:2000.
ous trainings was contrary to the process
The book I had previously used con-
approach promoted and required by the
process approach ever since 1998. It
tained 20 procedures, intended to be cut
standard. This standard-based approach
makes good sense in any organization.
and pasted into any organizations QMS
contradicts the standards endorsement of
Why wait until ISO 9001:2015 requires it
documentation. Why 20 procedures?
the process approach.
to reap the benefits of applying a process
There was one to address each of the 20

elements of the 1987 and 1994 versions of
The number of procedures required by
Ive been using and promoting the
approach? QP
an organizations management system de-
LOOKING FOR ISO 9001 INFORMATION?
Subscribe to Standards Connection at asq.org/standardsconnection. This monthly

enewsletter delivers the latest ISO 9001 revision updates, exclusive videos from
ASQs Standards Channel and expert answers to your standards questions.
T. DAN NELSON is the principal at

T.D. Nelson in Denver. He earned his
MBA from the University of Iowa in
Iowa City.
videos.asq.org/asq-standards-channel
ASQ Standards
Channel: All You
Need to Know About
ISO 9001:2015
Find pertinent answers to your burning
ISO 9001:2015 questions on the new
ASQ Standards Channel.
30-plus informational video interviews
with top experts
Free for ASQ members
Sponsored by
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15-03-09 1:49 PM
July 2015 QP 47
CAREER CORNER
BY JOSEPH D. CONKLIN
Behind the Interview Curtain

Effective interviewing techniques from an experienced manager
WHEN MY FRIEND Alan interview-
Rehearsing the interview
If the job requires writing, bring
ing managerheard I was applying for
His first suggestion wasnt surprising to
samples: a report from your current job,
a promotion, he sent me some helpful
hear from an actor: Dress appropriately
a presentation given to a professional
suggestions. He and I met more than 15
for the interview. Dress one level above
society or a published article from outside
years ago while working for the federal
the position youre seeking. Dont be
your organization. Bring more than one to
government, starting out as coworkers
over the topstand out, dont be ruled
show you communicate well in a variety
and continuing as friends after I moved
out.
of settings and styles. They dont need to
to another agency. Were both statisti-
A successful interviewer has stories
be more than a few pages.
cians, but Al is more of an extroverted,
ready that substantiate whats on his or
Even if theres not enough time to
people person, and his way with people
her rsum. They should be rehearsed
discuss all the samples, theyre good to
helped him ascend the management
well enough to sound smooth but not
leave behind to remind the interviewer of
ranks.
memorized. You dont want to prepare too
your abilities. If the job requires computer
much or too little. When I asked him what
programming skills, include samples of
local amateur theater. Being an actor has
kind of stories help on an interview, Al
code youve written.
benefited him on both sides of inter-
offered these questions:
views. Knowing Al as I do, I trusted hed
1. How did you handle missing a critical
In his spare time, he performs in a
researched the advice he was offering.
deadline when you knew you were going to be late?

2. How did you keep a proj-
I asked Al whether he had any thoughts

about providing references. He shared
a story from his own experience as an
ect on track while avoiding
interviewing manager, explaining how an
scope creep?
applicants references ruled him out from
3. How do you handle people

who are difficult to work
with or lead?
4. When a project seemed
being hired and illustrated some important lessons.

The applicants first reference contradicted a claim on his rsum. Thats
impossible and you didnt
always a no-no. He claimed credit for a
know where to start, what
masters thesis that was defended by a full
did you do next?
committee of professors. The first refer-
5. When actual costs far
ence explained the work was a project
exceeded expectations,
completed for one professornot a full
how did you handle the
thesisand he had not taught the appli-
situation?
cant in any of his classes.
6. How did you handle some-
The applicant was interviewing for
one trying to undercut or
a statistician position, and his second
threaten your reputation at
reference was an office manager. The
the office?
applicant created electronic spreadsheets
Even if you dont end
to help him run the business, but he
up needing it, bring a copy
couldnt speak to the applicants skills as
of your rsum to demon-
a statistician.
strate youre organized and
The right referrals
The third reference was difficult to
preparedqualities that are
track down. The contact information
always in demand.
provided by the applicant was outdated,
helpful and useful curiosity are:
and he hadnt worked at the company that
qualifications. As you answer the inter-
was listed for more than a year. Al spent
viewers questions, address when you can
1. Is this a newly created position?
hours calling three states to track down
start and how you would fit in with the
2. Why did the previous person move on?
the reference.
new organization. If time allows, summa-
3. How will I be evaluated after 90 days,

six months or a year?
The applicant was not offered the job.
rize any commitments you must complete
The important lesson about references is
at your current job before moving on. This
to make sure they are from people who
speaks to loyalty and finishing what you
opportunities in the organization might
know you personally, can address your
start.
I qualify for?
ability to meet the jobs requirements and
Standing out from other applicants is
4. If I am hired and do well, what other
Als final point showed his experience
your challenge. In Als experience, appli-
as an actor. He said to not be discouraged
cants didnt always ask about the impor-
if you dont get a job. That just means the
Are you qualified?
tant milestones expected during their first
interview was a rehearsal for your next
Al boiled down his next suggestion into
year on the job or lay out a vision for what
success. QP
three easy-to-remember points an inter-
they wanted to accomplish during the first
viewer should be convinced of:
year or two. Doing this well requires thor-
are easy to contact.
1. Im qualified.
ough study and consideration of the job
2. Im available.
requirements. Asking about and suggest-
3. I want to fit in.
ing future goals communicates your inter-
The stories youve prepared to demonstrate your experience can explain your
est and commitment to the interviewer.

Other questions that demonstrate a
JOSEPH D. CONKLIN is a mathematical

statistician in Washington, D.C. He
earned a masters degree in statistics
from Virginia Tech in Blacksburg and
is a senior member of ASQ. Conklin is
also an ASQ-certified quality manager,
engineer, auditor, reliability engineer
and Six Sigma Black Belt.
videos.asq.org/itea
Real-World Quality Improvement

Visit ASQ TVs new International Team Excellence Channel
and find out more about real-world quality improvement.
Access 30 recordings of quality impact sessions.
Learn from high-performing teams from around the world.
Learn techniques and strategies in a new way.
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July 2015 QP 49
October 27-29, 2015
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P r og ra m m i ng Pa r tn er s
Qu a l i ty S h o w. c o m
STATISTICS ROUNDTABLE
BY CHRISTOPHER A. SEAMAN,
JULIA E. SEAMAN AND I. ELAINE ALLEN
The Significance of Power

Avoid mistakenly rejecting the null hypothesis in statistical trials
THE CONCEPT OF power has long
been overshadowed in statistical circles
Power and statistical significance
by its big brother, significance. Both
Null hypothesis
should not be rejected
parameters, chosen before a test, dictate

the sample size and likelihood of making
an erroneous conclusion when comparing
two groups (see Table 1). The p-value or
significance threshold is the first taught
/ TABLE 1
Null hypothesis
should be rejected
Reject null hypothesis
False positive =
type I error
True negative = power
Do not reject null

hypothesis
True positive =
confidence interval
False negative =
type II error
and most commonly used statistic.

problems. A higher-power value indicates
with budget, time and project logistical
mistakenly rejecting the null hypothesis
a less likely chance for a false negative.
constraints.
that both groups are similar when the null
The power of a study is directly related to
hypothesis is indeed true. This mistaken
its sample size and effect size variability.
the study setup must reduce the risks
result is called a false positive (type I
In general, the greater the sample size
of being underpowered. If a study is
errors or ), and it means youve found a
and the lower the variability, the higher a
underpowered, the most direct issue that
difference between two groups when re-
studys power.
can arise is to refuse to reject the null
Significance sets the threshold for
ally they are not different.
Both of these study variables, however,
As power is a required part of testing,
hypothesis when, in fact, it is false. This
will increase time and cost. To completely
means that there is a real difference in the
controlling the complementary testing
eliminate any chance for false negatives
two groups being compared, but the test is
problem to reduce false negatives (type II
and for the best study, you must test every
unable to detect it.
errors or ). Power determines how likely
possible option to the absolute physical
a test is to reject the null hypothesis when
limit of measurement. In reality, therefore,
comes in the form of reproducibility of
the null hypothesis is false.
there is a balancing act between increas-
results. One study may find significant
ing power through more samples and
differences between two groups, but
more precise and accurate measurements
when others attempt to achieve the same
Power, on the other hand, focuses on
When a statistical trial is conducted

without enough power, it can lead to
A more nuanced issue with power
results, they do not find a difference. This

could be a symptom of underpowered
follow-up study.
As Figure 1 (p. 52) shows the greater
the discrimination between your type I and
type II errors, the higher the power and
lower the significance level of the study,
and the easier it is to discriminate between
the null and alternative hypotheses.
In the first test (A), there is a high
chance for type I and type II errors, as
evidenced by the high overlap between the
curves. In the second test (B), the study
was designed with higher power (increased sample size and lower measurement variability), and there is much less
overlap between the two groups.
July 2015 QP 51
STATISTICS ROUNDTABLE
Comparing the difference between

2 distinct groups with low and high
power / FIGURE 1
As the effect size (movement difference)

increases and variability decreases, the
required sample size per group decreases
from a maximum of 20 per group (with
largest variability and smallest movement
Test A
difference) to a minimum or four per
Test B
Group 1
Group 2
Group 1
Group 2
group at the opposite end of the spectrum.

Suppose you have invented an easier
appliance for orthodontic braces that
accelerates the movement of teeth. Your
hypothesis is that the new appliance will
-25 -20 -15 -10 -5
10 15 20 25
-25 -20 -15 -10 -5
10 15 20 25
show between 0.5 and 1.25 mm more

movement per month than the old appliance, and the variability will be between
Specifying and
two groups or the percentage change be-
0.20 and 0.50 mm per month. You will test
Ideally, the sample size of an experiment
tween groups. The sample size calculated
this with a two-sided paired t-test with
(or statistical trial) is calculated a priori
using these parameters gives an investiga-
a significance level of = 0.05 and 80%
using investigator-chosen prespecified
tor the minimal detectable effect in the
power.
levels of significance and power. These
study.
To achieve those set levels, you must

have four to 20 subjects per treatment. To
Because the effect size may not be
are often a significance level = 0.05 (5%

error is our threshold or 95% confidence),
fixed and the variability may not be
confidently declare that the new braces
and 1- (or power) = 80% or 90%.
known, it may be important to calculate
are better, you need the fewest patients if
a table of sample sizes for a given and
you have the greatest movement with the
1, this means you may wish to be 90%
, varying the effect size and variability
lowest variability. Conversely, you need
confident that you are rejecting the null
of measurement to optimize the study's
the most patients if there is little differ-
hypothesis when it should be rejected,
design. There are sample-size calculators
ence in movement and a lot of variability
and only allowing a false negative rate of
in most statistical packages and online
(see Table 2).
5% to reject the null hypothesis when it
(http://tinyurl.com/sample-size-calc) that
should not be rejected.
can be tailored for the exact type of test
In terms of the errors listed in Table
For a sample size calculation, a priori
being performed.
The power example that follows shows
one needs a value of , a value of 1 and
Dangers of overpowering,
underpowering
Using the braces example, suppose you
an effect-size measure. The effect size is
how you might develop a sample-size
decide that you expect the variability to be
often the difference between means of
strategy based on a fixed value of and .
0.25-0.30 mm and the movement to be 0.75

mm per month, and you enroll 10 patients
per group for the study. At the end of the
Sample size per treatment required

for movement difference and
variability within appliance / TABLE 2
study, however, the movement is only 0.50

mm per month and the variability greater
than 0.40 mm.
Using your sample-size calculations,
you needed to enroll 14 to 20 patients in
Variability
Movement
difference/month
the study. This indicates the sample size
0.20
0.25
0.30
0.35
0.40
0.45
0.50
0.5 mm
10
12
12
14
14
16
20
0.75 mm
10
10
12
12
14
18
1.0 mm
10
12
1.25 mm
was too small, and the study is underpowered. The completed 10-patient study will
not have a statistically significant result at
your set significance and power levels.
Using this example, a more likely
reason for an underpowered study is that
you only have funding for 10 patients

per group, regardless of the power and
sample size estimates. After completing a
Pitfalls of underpowering and

overpowering a study / TABLE 3
study, you can calculate the actual power
Not a statistically
significant difference
of the study given the actual effect size

and variability. This is the post-hoc power
andwhile seldom reported in published
resultscan be helpful when designing
Important difference
Underpowered =
too small of a sample
Unimportant difference
True positive
Statistically
significant difference
True negative
future studies, especially when the original
Overpowered =
too large of a sample
study is underpowered.
Overpowering a study by increasing
the sample size has been called a waste
their results are not clinically meaningful
variability. The best study will be well
of resources when it involves the use of
or actionable.
balanced among all four parameters,
humans or animals. But can too many
In some rare instances, overpower-
adjusting for the restrictions from the
ing a study can be useful for examining
reality of data availability, budgets and
Studies are increasing in size as the
outcomes more precisely. It may give
deadlines. QP
prevalence of big data is seen in all areas
investigators a result, however, that is
of investigation. If the sample size is very
statistically significant but not an impor-
large, everything may be statistically
tant difference. Table 3 illustrates these
significantbut these results may not be
pitfalls.
observations ever be a bad thing?
Studies are increasing in

size as the prevalence of big
data is seen in all areas of
investigation.
important results from the study.
As the sample size increases, the
Well-balanced power
Although overshadowed by the p-value,
effect size and variability shrink, which
power is an important aspect of study
gives the results more precision than
design, controlling the error of false
can be measured with the available tools
negatives. As many studies are carefully
or have clinical usefulness in a new
designed to avoid falsely rejecting the null
intervention.
hypothesis, these studies also must ensure
In extreme cases, investigators can

actually game the system and claim
statistical significance simply by virtue of
having an extremely large sample size, but
THREES NOT A CROWD
they do not falsely accept the null hypothesis through power.

Power is associated with significance
levels, sample sizes and effect size
Read another Statistics Roundtable column from this trio of authors. So Many
Variables, So Few Observations appeared in the September 2013 edition of QP.
Visit http://tinyurl.com/seaman-stats-round to access the article.
ADDITIONAL RESOURCES
Button, Katherine S., John P.A. Ioannidis, et al., Power Failure:
Why Small Sample Size Undermines the Reliability of
Neuroscience, Nature Reviews: Neuroscience, May 2013,
Vol. 14, pp. 365-376.
Gelman, Andrew and David Weakliem, Of Beauty, Sex and
Power, American Scientist, July-August 2009, Vol. 97, No.
4, pp. 310-316.
Hochster, Howard S., The Power of P: On Overpowered
Clinical Trials and Positive Results, Gastrointestinal
Cancer Research, 2008, Vol. 2, No. 2, pp. 108-109.
Seaman, Christopher and I. Elaine Allen, Different, Equivalent
or Both, Quality Progress, July 2006, pp. 77-79.
Seaman, Julia and I. Elaine Allen, Not Significant, But Important, Quality Progress, August 2011, pp. 58-59.
CHRISTOPHER A. SEAMAN is a data

scientist at Atlassian in San Francisco and a statistical consultant
for the Quahog Research Group
in Oakland, CA. He has a masters
degree in mathematics from the
Graduate Center of the City University of New York.
JULIA E. SEAMAN is a doctoral student
in pharmacogenomics at the University of California-San Francisco, and a
statistical consultant for the Babson
Survey Research Group at Babson
College in Wellesley, MA. She earned
a bachelors degree in chemistry and
mathematics from Pomona College in
Claremont, CA. Seaman is a member of ASQ.
I. ELAINE ALLEN is professor of
biostatistics at the University
of California-San Francisco and
emeritus professor of statistics at
Babson College. She is also director of the Babson Survey Research
Group. She earned a doctorate in
statistics from Cornell University in
Ithaca, NY. Allen is a member of ASQ.
July 2015 QP 53
STANDARDS OUTLOOK
BY L.L. BUDDY CRESSIONNIE
On-Time Departure
Revised AS9100 series standards on schedule for 2016 publication
THE INTERNATIONAL Aerospace Quality Group (IAQG) recently announced that
ed by aerospace industry stakeholders.

The AS9100 series standards include
repair and operations (MRO)-centric

and to improve consistency with
the AS9100:2016 series of standards is on
the following IAQG standards, with
civil and military aviation regulatory
track to be released for sector publication
AS9100 being the series baseline standard:
requirements. The applicability of
in April 2016.
AS9100Quality management
this standard is extended to airlines
The reason for the revision is that

the AS9100 series is based on ISO 9001,
therefore, it is affected by the revision to
systemsRequirements for aviation,
performing continuing airworthiness
space and defense organizations.
management activities in addition to
existing stakeholders, such as MRO
ISO 9001 being published later this year,
systemsRequirements for aviation
and original equipment manufacturers
the IAQG five-year review cycle as well
maintenance organizations.
that provide maintenance services.
as opportunities for improvement. ISO
AS9115. Revisions include adding con-
9001:2015 is scheduled for publication in
tent to enhance cybersecurity protec-
September, and organizations currently
space and defense organizationsDe-
tions for software quality management
certified to it will have a three-year transi-
liverable software.
systems, and recognizing cloud-based
tion period.
The goal of the AS9100 series revision
services and mobile applications.

AS9120. Revisions include improved
is to retain alignment to ISO 9001:2015,
space and defense distributors.4
coverage of quality requirements for
while also addressing specific aerospace
Table 1 shows new and revised areas in
prevention of counterfeit and unap-
industry and stakeholder needs.

Revising AS9100 standards allows the
the AS9100:2016 series of standards.

The AS9100 series standards being
proved parts. Even though AS9101

Quality management systemsAvia-
aerospace industry to continuously im-
revised to harmonize with AS9100 and to
tion, space and defense audits isnt
prove, and also allows IAQG to enhance
address stakeholder inputs are:
part of the series that uses ISO 9001 as
or add requirements that may not be in
AS9110. Revisions include updat-
a baseline, it is being revised in parallel
ISO 9001:2015 but that have been request-
ing content to be more maintenance,
with the AS9100 series to incorporate

structure changes from AS9100 and
ISO 17021. AS9101 is a crucial element
for the transition of the AS9100 series.
The schedule for the release of the
AS9100 series includes three major milestones:
1. July 2015. A coordination draft is
being released, allowing key stakeholders to provide feedback. This is the
first time the draft standard is being
circulated outside of the AS9100 series
writing teams.
2. December 2015. An IAQG ballot of
the AS9100 series of standards will be
conducted. This will be a sector review
across the three IAQG sectors (Americas, Europe and Asia Pacific). The writ-
ing team will analyze comments from the

ballot and make necessary changes. If
technical content changes, other ballots will be required until the standard
can be approved as balloted.5
New and revised areas in the

AS9100:2016 series / TABLE 1
Product safety
Added in carefully selected areas with consideration of current

AS9110 requirements to ensure product safety during the entire
life cycle.
Human factors
Added as a consideration in the nonconformity and corrective

action clause to ensure the true root cause is identified and to
ensure nonconformities do not recur.
Risk
Merged current AS9100 series (operation) risk management

requirements with the new ISO 9001 requirements on risk-based
thinking, which permeates the entire management system.
Preventive
action
Current clause requirements absorbed into risk and opportunities,

and nonconformity and corrective action clauses. The International
Aerospace Quality Group AS9100-series reinforced this concept
with several additions.
Counterfeit
parts
Introduced in carefully selected areas to establish basic

requirements appropriate to the product.
Project
management
Combined with the operation planning clause to address user

interpretation issues.
Configuration
management
Clause clarified and improved considerably to address stakeholder

needs to specify requirements in more simplified terms.
Post delivery
support
Merged current AS9100 series requirements with the new ISO

9001 requirements.
Product
realization
and planning
Clarified and enhanced planning throughout the standard.
3. April 2016. The AS9100 series

standards will be released for sector
publication.
Support materials available

IAQG publishes support materials
on the www.iaqg.org website to help
users understand standards and make
implementation easier. The significant
amount of information available for
IAQG standards includes frequently
asked questions, summary presentations, articles, specific topic discussions
on new or enhanced requirements, and
posted clarifications.
The IAQG 9100 revision team is
getting ahead of the game by populating content for AS9100:2016 to help
stakeholders in preparations and communications. Content for this purpose
includes:
AS9100:2016 series revision
overview. This presentation includes information on IAQGs ISO
9001 revision activity, AS9100 series
revision activity, benefits and application of the standards, communications materials, a summary of revision
activities and resource links.
AS9100:2016 key changes presentation. This presentation highlights
some of the significant changes from
AS9100:2009 to AS9100:2016.
AS9100:2016 comparison. This
table shows the alignment between
AS9100:2009 and AS9100:2016.
REFERENCES
1. International Aerospace Quality Group, AS9100Quality management systemsRequirements for aviation,
space and defense organizations.
2. International Aerospace Quality Group, AS9110Quality management systemsRequirements for aviation
maintenance organizations.
space and defense organizationsDeliverable software.
space and defense distributors.
5. L.L. Buddy Cressionnie, Road to Revision, Quality
Progress, July 2013, pp. 47-49.
L.L. BUDDY CRESSIONNIE is the

Americas requirement IAQG 9100
team lead and a voting member of U.S.
Technical Advisory Group to ISO/TC 176.
In these roles, he represents Lockheed
Martin Corp., where he works in the
aeronautics business area overseeing
quality management system processes.
Cressionnie is an ASQ senior member
with manager of quality/organizational excellence and quality
auditor certifications. He also is an Exemplar Global-certified
aerospace auditor and International Register of Certified Auditors lead auditor for ISO 9001 and ISO 14001. Cressionnie has
an MBA from Texas Christian University in Fort Worth and a
bachelors degree in industrial and systems engineering from
the University of Florida in Gainesville.
IAQG is seeking feedback using the

online aerospace supplier information
system regarding any need for clarification or questions users have during this
transition. QP
REVISION TIPS FROM THE EXPERTS
Watch video interviews with standards experts discussing the ISO 9001 revision
and its effect on industries such as aerospace on ASQs Standards Channel at
http://videos.asq.org/asq-standards-channel.
July 2015 QP 55
Special Advertising Section
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The Corporate University
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Kent State University provides lean and Six Sigma training and process
improvement consulting services to meet your continuous improvement
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UCSC SILICON VALLEY EXTENSION
2505 Augustine Drive

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Phone: 408-861-3700
ucsc-extension.edu
UCSC Extension is located in the heart of Silicon Valley and provides online and
in-person continuing education courses to engineers, scientists, educators and
business professionals.
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VERSE SOLUTIONS
399 Conklin St., Suite 208

Farmingdale, NY 11735
Phone: 423-388-3777
www.versesolutions.com
VERSE is a dedicated cloud-based quality management system that provides the
dynamic performance of an on-premises solution without the long-term commitment.
AUDITING CONTINUOUS QUALITY IMPROVEMENT ISO 9000
MANAGEMENT OPERATIONS MANAGEMENT PERFORMANCE
IMPROVEMENT QUALITY ASSURANCE SaaS SUPPLY CHAIN
MANAGEMENT TECHNOLOGY TOTAL QUALITY MANAGEMENT
July 2015 QP 57
QPTOOLBOX
Ultrasonic test machine
specification.
Enerpac has released the PTW-series
The ROWA-WT ultrasonic test machine
Visit: www.gemeasurement.com.
pneumatic torque wrenches. The series
for tube and pipe from GE Measurement
Call: 978-437-1272.
offers constant torque outputreducing
and Control combines signal processing
production downtime for bolting applica-
with phased-array ultrasonic technology,
Digital pressure transducers
tions in mining, power generation, and oil
which are electronically controlled to
GP:50 has unveiled its Model 611/612
and gas industries.
provide full coverage of the tube circum-
series of USB-powered digital pressure
ference and are coupled to the surface by
transducers with automatic temperature
a rotating water jacket.
and pressure output recognition. The
Pneumatic torque wrenches
The PTW-series tools provide operators with a trigger-style handle and allows
for quick accessibility to tightening and
There is no need to rotate the tube
series offers an 18-bit resolution and a 4.8
loosening control, eliminating the dangers
or move the transducers during testing.
KHz internal measurement rate. Mea-
of manual tightening.
The machine is purpose-designed for
sured pressure values in absolute, gauge,
carrying out dimensional and wall thick-
sealed gauge or vacuum formats may
regulator-lubricator so operators have
ness measurement of seamless pipe. It
be logged in real-time on PCs or mobile
the necessary components to use the
measures inside and outside diameter
devices.
wrench. The PTW-series tools are avail-
and wall thickness and checks for oval-
Available field options include a 1 to
able with custom arms, accessories and
ity, eccentricity inner-wall deformation
500 Hz adjustable response time, adjust-
come in various lengths.
and laminations. It also can detect
able baud rate, adjustable station num-
Visit: www.enerpac.com.
flaws to a level of 6.3, 6.0 and 3.2 mm
bers, and digital shunt calibration. They
Call: 262-293-1655.
flat bottom hole depending on the
are multi-drop and field configurable, with
These tools also come with a filter-
optional field re-zero functionality.

Typical applications for the Model
611/612 Series include oil and gas pipeline
and valve pressure testing; portable test
stands; in-laboratory research; hydrostatic test stands; and calibration stands.
Call: 877-774-4781.
Visit: www.gp50.com.
Software
JOT Automations JOT M10 Six Slider provides software loading for smartphones,
making it an ideal solution for mass
manufacturing. It is applicable for downloading software to assembled products or at the board level. The software
downloading process can be automated
by integrating boxes to JOT M10 handlers
without any modifications to the boxes.
The modular system architecture
enables adaptation to production volume
distribution of reflected light using

Delta-S technology, which allows
the sensor to determine the
gloss level of flat object surfaces,
differentiate between objects of
different gloss levels, and provide
reliable gloss identification regardless of color, labeling or structure.
The Glare sensor can be
configured in different operating
modes to meet the requirements
of applications such as detecting tamper-proof seals or tape,
coatings, surface treatments and
protective foil packaging.
The Glare sensor features
sensitivity adjustments that increase
legibility and completeness
operational safety, and an integrated
allowing manufacturers to see any de-
key lock that reduces the risk of operat-
viations from the specified quality.
ing errors or tampering.
The LCS prevents incorrect or illegible
variations during a products life cycle
Email: santi.clarke@sick.com.
labels from getting into circulation. This
and also between the production lines
Visit: www.sickusa.com.
protects manufacturers from the threat
and factories. The box has a clear
of contractual penalties or product
Label check station
of space for customized cabling and
Mettler Toledos label check station
Visit: www.us.mt.com.
electronics. The JOT M10 Six Slider is
(LCS) prints and verifies labels automati-
Call: 800-638-8537.
also applicable to dozens of other uses
cally. Food manufacturers can use the
beyond software downloading.
LCS to print product-specific labels at a
Email: mika.puttonen@jotautomation.
rate of up to 500 per minute. It also can
com.
recalls due to incorrect labeling.
print labels that provide batch or other
Visit: www.jotautomation.com.
Sensor
interface for customization and plenty
product-specific information and comply

with applicable standards.
The system combines a printing mod-
Sicks Glare sensor recognizes and dif-
ule with a high-resolution camera and
ferentiates objects on the basis of their
a reject system for faulty labels. After
gloss to control production processes.
the labels are printed, a high-resolution
The Glare sensor analyzes the spatial
camera checks quality factors such as
GOT A QUALITY PRODUCT?
Send your product description and photo to vellifson@asq.org.
July 2015 QP 59
QPREVIEWS
Trust and Organizations:
Confidence Across Borders
people work in organizations based on
examples on how to use the concept then
trust. Examples are institutions such as
follow. In addition, the book includes many
Marta Reuter, Filip Wijkstrm and Bengt
banks, schools, accounting firms and medi-
statistical tables used in the examples. By
Kristensson Uggla, editors, Palgrave Mac-
cal practices that must deliver confidence
including these examples in each chapter,
millan, 2013, 224 pp., $115 (book).
to customers, students and patients. The
the author has fulfilled the promise of
Exploration of trust
experience and professional expertise of
making this book a useful resource for the
within and between
the staff and systems in place for quality
aforementioned professionals, allowing
organizations, and
control are very important. The authors
them to use the information in an efficient
then between
explore mechanisms developed to create,
and effective manner and giving the book
organizations across
manage, confirm and deliver trust in com-
an advantage over other publications cov-
national borders,
panies, government, private organizations
ering the same topic.
is an important
and public administrations.
topic. This book is
By grouping the chapters and 17 statistiGerald Brong
a compilation of
Ellensburg, WA
10 papers from an
cal tables into the engineering, process and

reliability applications, the author could
have made searching for a specific concept
more efficient. In addition, in the preface, it
ated with European programs. The papers
Practical Engineering, Process,

and Reliability Statistics
are presented as chapters and investigate
Mark Allen Durivage, ASQ Quality Press,
been exposed to basic statistical concepts;
what happens to trust and confidence in
2015, 288 pp., $42 member, $70 list (book).
however, it is not clear what these basic
interdisciplinary group of academics affili-
is stated the book assumes the reader has
the unpredictable space between concep-
Since the beginning
concepts entail and whether they are cov-
tualization, theory, practice and the assess-
of the industrial
ered in the book.
ment of results.
revolution, the use
Quality is not the primary focus of
Regardless of these minor shortcomings,
of statistical tools
this book helps those readers prepare for
this book but implementation of quality
and techniques has
and take various ASQ certification exams.
programs, identification of standards and
become a neces-
It also can be beneficial to other engineer-
enforcement of requirements requires con-
sity for many engi-
ing and quality professionals who wish to
fidence and trustespecially if its to cross
neering, manufac-
sustain and improve various processes in
borders. Trust and confidence are explored
turing and quality
their organizations.
in relation to different types of borders or
practitioners. These
Herzl Marouni
boundariesinstitutional, organizational
professionals are tasked with ensuring the
and geographicalas the overlapping and
manufacturing processes they are involved
blurring of such boundaries become char-
with remain capable, and the products they
acteristics of the increasingly transnational
are responsible for meet design and reli-
world.
ability requirements. I found this book to be
Global Supply Chains:

Evaluating Regions on an
EPIC Framework
It is interesting to note that interna-
Houston
a valuable resource that could help these
Mandyam Srinivasan, Theodore Stank,
tional quality programs and standards
individuals to manage these tasks more ef-
Philippe-Pierre Dornier and Kenneth
are key points of emphasis in the papers
fectively and efficiently.
Petersen, McGraw-Hill Professional, 2013,
presented. Insights offered in the papers
The book is organized into 25 chapters,
448 pp., $70 (book).
are useful for those involved in challenging
and each chapter includes a brief state-
This book offers readers a lot of informa-
international processes requiring delivery
ment on the chapters focus and a detailed
tion. The authors give their evaluation of
of confirmed quality results.
description of a specific statistical and reli-
regional conditions and how they affect the
ability concept covered. Several practical
supply chain and the movement of goods
In all sectors, an increasing number of
within that locale. Supply chain is defined
This book will be extremely helpful for
Most chapters are descriptive and
as a worldwide network of suppliers, manu-
organizations or service providers who are
factual without in-depth synthesis except
facturers, planned infrastructure in the form
considering expanding into an unknown
for the final chapter on new ways to think
of transportation networks, availability of
area, or if a customer adds a location in a
about business education for emerging
electricity, IT infrastructure, warehouses,
faraway place.
markets. This chapter discusses six basic
distribution centers and retailers through
Marc A. Feldman
which materials are
Houston
acquired, trans-
functions of higher education:

1. Information dissemination.
2. Directed activities.
3. Feedback and evaluation.
ered to customers.
Innovation in Business
Education in Emerging Markets
Forward supply
Ilan Alon, Victoria Jones and John R.
5. Content selection.
chain and reverse
McIntyre, editors, Palgrave Macmillan,
6. Credentialing.
supply chain activi-
2013, 296 pp., $115 (book).
formed and deliv-
ties are considered.

Ten global
4. Knowledge creation.
Overall, the chapters are rather short,
This book includes
providing a high-level view, but the bibliog-
15 chapters orga-
raphies are detailed and comprehensive.
regions are identified. Short summaries for
nized into three
As indicated, the book is relevant to and
each country with a significant supply chain
parts: regional
recommended for experts in business edu-
within the region are presented. Each coun-
trajectories, content
cation and libraries in business schools and
try is then assessed on the following, using
adaptations and new
schools of education.
a weighted EPIC scale:
directions. In a sense,
Economy: wealth and resources in
it is a very special-
terms of production and consumption.
Ron S. Kenett
Raanana, Israel
ized document with
Politics: political landscape with respect
a lot of useful and
to how well it nurtures supply chain
interesting information for experts in educa-
activity.
tion in emerging countries.
RECENT RELEASE
infrastructure in the form of transporta-
massive open online course (MOOC) applica-
Coaching Green Belts for

Sustainable Success
tion networks, availability of electricity
tions and MOOC pedagogy. Chapter 11 on
Steve Pollock and Daro Mott, ASQ Quality
and power and IT infrastructure.
mobile apps in education touches on similar
Press, 2015, 204 pp., $36 member, $60 list
issues but falls short of discussing MOOCs.
(book).
Infrastructure: existing and planned
Competence: competence of workforce,
An obvious topic missing from the book is
logistics and speed of customs and security clearance.

What results is a final scorecard (A
through F) with comments for each identified country, and the region as a whole.
Additional explanations are given,
including EPIC variables and their sources,
decision uses for the EPIC variables and a
consideration of total cost of ownership
Advertisers Index
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The Quality Show
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July 2015 QP
61
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ONE GOOD IDEA
BY JIM JOHNSTONE
Agile Quality
Software-development principles create more product value
LAST YEAR, I researched agile software
are always discovering and evolving what
ideas comes from understanding custom-
development for ASQ Austin Sections
makes an excellent product, and they use
ers motivations and problems. Combine
quality seminar. Its an approach based
existing products in new ways that you
this with your employees knowledge as a
on iterative and incremental development,
did not anticipate.
resource for learning how to produce new
where requirements and solutions evolve
3. Product lead times should be
through collaboration between self-orga-
shortCustomer demand is perishable.
nizing, cross-functional teams.
The internet has created global competi-
products faster, cheaper and with better

quality.
9. Focus on technical excellence
When agile principles are properly
tion for customers, and low-cost technol-
and good designProduct excellence
deployed, they can produce products that
ogy enables more sophisticated solutions
comes from an organizations culture,
yield twice the value in half the develop-
to customer needs.
starting at the top and working its way
Apply the theory of constraints (a
down. People enjoy working in a quality-
apply these principles to help my clients im-
method for finding constraints block-
first, customer-centric environment more
prove their quality management systems?
ing the achievement of goals) to shorten
than one focused on cost.
ment time. I asked myself, How could I
development and delivery cycle times, and
Agile principles
retain customers.5
10. Simplicity is essentialWhen

you start a project, ask yourself: What is
the simplest way to accomplish my goal?
In 2001, the Agile Manifesto was created
4. New products that meet custom-
based on 12 principles. I adapted them to
ers needs are the principle measure of
Value stream mapping is a good way to
apply to any organization.2
progressYour customers needs always
analyze product or process simplicity.

11. Self-organizing teamsTechni-
1. Customer satisfaction by rapid
change. You must consistently introduce
delivery of useful productsCustomer
new products to meet those needs and be
cal talent cant succeed alone. Not every-
satisfaction is everything. Agile develop-
able to cope with the rate of change.
one has leadership and organizational
ers found that 80% of a products value
5. Sustainable, rapid product de-
skills. You need leaders at every level
was in 20% of its features mirroring the
velopmentAnalyze your organizations
in your organization and training on the
Pareto principleand developers should
processes using value stream or business
principles of organizing teams.
first focus on completing that valuable
process mapping to find bottlenecks and
20% of the product.3, 4
expand their capabilities to grow business.
From listening to customers talk about
6. Close, daily cooperation between
12. Adapt to changing circumstancesAnticipate how you can extend

or adapt your current strategy when
their problems, can you determine which
business people and developers
circumstances change, and consider your
ones they are trying to solve with your
Developers are creative. This must be
alternatives because optimization comes
product? Responding quickly to custom-
balanced with pragmatism for profitability
from choicesone of which may be start-
ers needs provides them instant solutions
and creating easily produced products.
ing over.
to their problems.
7. Face-to-face conversation is the
Adopting agile principles helped me
best form of communicationGreat
complete more useful work in less time
failure mode and effects analysis, you
customer relationships are built around
and help my clients achieve their goals. QP
reduce the risk of product flaws that could
people, not paper. Specs are important,
worsen a customers issue. When flaws
but rarely convey all the information, and
are found, respond with a rapid, thorough
they may contain conflicting information
root-cause investigation. Customers
that requires interpretation. Your interpre-
confidence in your organization can be
tation may not be the same as a custom-
restored though rapid corrections that are
ers, so you should talk it over.
By using quality tools, such as design
validated by data.
2. Welcome changing requirements,
even late in developmentCustomers
8. Projects are built around motivated individuals who should be

trustedThe best source of innovative
EDITORS NOTE
The references listed in this article can be found on the One
Good Idea webpage at www.qualityprogress.com.
JIM JOHNSTONE is the owner of
Johnstone Global Consulting Services
in Austin, TX. He earned a masters
degree in electrical engineering
from Ohio University in Athens. A
senior member, Johnstone is an ASQcertified quality engineer, auditor and
Six Sigma Black Belt.
July 2015 QP 63
BACK TO BASICS
BY JOSEPH PAUL MITCHELL
Substantiation Test
Hypothesis test provides unbiased, statistics-based solutions
HYPOTHESIS TESTING IS one of many
The process
Handbook.1 The p-value is a conditional
Six Sigma tools and techniques used for
Steel tubing is processed in a tempering
probability: In other words, if the UTS of
process improvement. Recently, it was part
oven. Following the tempering process,
tubes processed in January are the same
of a manufacturers define, measure, ana-
one tube per load is randomly selected and
as February, what is the likelihood of
lyze, improve and control (DMAIC) inves-
tensile tested. The mechanical property
observing this same data versus observing
tigation concerning a suspected variance
chosen for investigation was ultimate ten-
data that are significantly different?
of mechanical properties in steel tubing. In
sile strength (UTS)the maximum stress
A statistical software program using an
this case, the products population standard
the tube can withstand before it fractures.
Anderson-Darling testused to see whether
deviation was unknown, and consequently,

a two-sample t-test was used.
In January, a total of 80 loads were
a sample of data came from a population
processed without straightening issues.
with a specific distribution2indicated
Data showed the mean UTS for January
normal data sets for January and February.
The problem
was 210.7 kilopounds per square inch
Statistical software calculations showed
The investigation took place at an organi-
(KSI) (see Online Figure 1, which can be
(see Online Tables 1 and 2): p-value = 0.000.
zation that fabricates steel tubing for com-
found on this columns webpage at www.
mercial or industrial applications.
qualityprogress.com). Management was
esis was rejected. The result suggested a
Manufacturing specifications for steel
unsure if the mean UTS for February (see
change in UTS had occurred: It increased.
tubing ensure the material will form during
Online Figure 2) had changed because no
the fabrication process. In February, opera-
control charts or other statistical process
Test results
tors of equipment that straighten and form
control charts were used for monitoring
The results from hypothesis testing
tubing complained that the material was
the tempering oven.
prompted investigation of the tempering
difficult to form, resulting in less-efficient
The current quality system was pass/
Based on the p-value, the null hypoth-
oven, and the inspection confirmed a heat-
production due to constant equipment
failthe UTS specification was 200 KSI
ing element was failing and needed to be
adjustments.
(+/ 25). This type of quality practice is
replaced. Due to this condition, the oven
known as lot-acceptance sampling, and it
was unable to reach the correct tempering
variation in material properties. During the
does not evaluate the quality of the load
temperature, and consequently, the tubing
measurement phase of DMAIC, a process
and only provides a basis for conclud-
did not receive proper heat treatment.
map was constructed. Based on the steps
ing all parts are acceptable for further
shown, a key input variable was determined
processing.
One possible cause of the problem was a
to be the tempering processthe last heat
Management realized a significant
Hypothesis testing is a valuable tool

for determining whether the difference
between two means is greater than what
treatment the material undergoes prior to
change in UTS may contribute to straight-
straightening and forming operations.
ening difficulties.
Hypothesis
test steps /
The claim
opposed to emotions and unsubstantiated
Based on the changes in UTS, hypoth-
presuppositions. QP
would be expected from chance.

This allows for an unbiased decision
based on statistics and probability, as
1.
2.
3.
4.
TABLE 1
The claim
Null hypothesis: (H0: = 211 KSI).
H0: After tempering, mean UTS did
not change.
Alternative hypothesis: (Ha: 211 KSI).
H1: After tempering, mean UTS did change.
Level of significance.
= 0.05
p-value.
KSI = kilopounds per square inch
esis testing was proposed. Hypothesis

testing requires only a few steps: a null
hypothesis, alternative hypothesis, level of
significance and p-value. Table 1 shows the
hypothesis test used in this scenario.
The significance level is the probability of making the mistake of rejecting the
null hypothesis when it is in fact true,
states The Certified Quality Engineer
REFERENCES
1. Connie M. Borror, ed., The Certified Quality Engineer Handbook, third edition, ASQ Quality Press, 2009.
2. Anderson-Darling Normality Test, iSixSigma.com, http://
tinyurl.com/n34yb22.
JOSEPH PAUL MITCHELL is a metallurgist at True Temper Sports Inc. in
Amory, MS. He earned his MBA from
Lawrence Technological University
in Southfield, MI. A member of ASQ,
Mitchell is an ASQ-certified quality
engineer.
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QUALITY PROGRESS | JULY 2015

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www.qualityprogress.com | July 2015

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