QUALITY PROGRESS | JULY 2015
Putting Best Practices to Work
www.qualityprogress.com | July 2015
Strumming Up Business:
Quality Guitar Strings
QUALITY PROGRESS QUALITY SS
ISO 9001:2015’S EFFECT ON OTHER STANDARDS
Change on the
Plus: Flip the switch to quality p. 30 Test your improvement theory p. 36
VOLUME 48/NUMBER 7
The Global Voice of Quality
ISO 9001:2015 precipitates revisions to other standards p. 18
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The Global Voice of Quality
Contents Putting Best Practices to Work | July 2015 | www.qualityprogress.com
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
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
Turning on the Light Bulb
Seven critical reflection methods to help quality newcomers understand and fully embrace quality principles.
by John Robert Dew
What‘s Your Theory?
A new way to develop, test and refine theories to improve a process, redesign a service or create new products.
by Brandon Bennett and Lloyd Provost
• Stay Connected
Subscribe to ASQ’s 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.
14 58 60
• Removing the silo effect. • Can quality slow innovation? • Switching ANSI standards.
• Automakers‘ use of common parts can compound problems. • Argentinian team takes gold at WCQI.
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Quality Progress is a peer-reviewed publication with 85% of its feature articles written by quality professionals. For information about submitting an article, call Valerie Ellifson at 800-248-1946 x7373, or email [email protected]
COLUMNS 5 44 46
Measure for Measure Metrological traceability to non-SI units.
Quality in the First Person Dealing with substandard ISO 9001 training.
Hiring manager offers advice to job interviewees. Wrongly rejecting the null hypothesis in statistical trials.
One Good Idea
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 ASQ’S CONTINUING EDUCATION AND PROFESSIONAL DEVELOPMENT DIRECTORY p. 56
- 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.
ASQ’s Vision: By making quality a global priority, an organizational imperative and a personal ethic, the American Society for Quality becomes the community for everyone who seeks quality technology, concepts or tools to improve themselves and their world. Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203. Editorial and advertising offices: 414-272-8575. Periodicals postage paid at Milwaukee, WI, and at additional mailing offices. Institutional subscriptions are held in the name of a company, corporation, government agency or library. Requests for back issues must be prepaid and are based on availability: ASQ members $17 per copy; nonmembers $25 per copy. Canadian GST #128717618, Canadian Publications Mail Agreement #40030175. Canada Post: Return undeliverables to 2835 Kew Drive, Windsor, ON N8T 3B7. Prices are subject to change without prior notification. © 2015 by ASQ. No claim for missing issues will be accepted after three months following the month of publication of the issue for domestic addresses and six months for Canadian and international addresses. Postmaster: Please send address changes to the American Society for Quality, PO Box 3005, Milwaukee, WI 53201-3005. Printed in USA.
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EXECUTIVE EDITOR AND ASSOCIATE PUBLISHER
ISO 9001 revision impacts other standards
ASSOCIATE EDITOR ASSISTANT EDITOR
SHORTLY AFTER I joined the QP staff in late 2006, discussion began heating up about
the 2008 revision of ISO 9001. Almost nine years later (and a bit older and wiser), I
understand much better the true impact—and related angst—about 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 we’ve published and will continue to publish on the topic, ASQ offers: • The ASQ Standards Channel: http://videos.asq.org/asq-standards-channel.
COPY EDITOR Susan E. Daniels
CONTRIBUTING EDITOR Tyler Gaskill
ART DIRECTOR Mary Uttech
GRAPHIC DESIGNER Sandy Wyss
• The Standards Connection enewsletter: http://asq.org/standardsconnection.
• The International Conference on Quality Standards: http://asq.org/conferences/
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 standard’s 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 chains—at 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 isn’t making any of the same mistakes. Finally, the Standards Outlook column, p. 54, outlines the revision of the AS9100 series standards.
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ASQ ADMINISTRATION Every July, we ask readers to participate in our Salary Survey of quality professionals. Your input is essential to collecting the data and providing useful salary-related guidelines to the quality community. Please visit www.asq.org/2015-qp-salarysurvey and take a few minutes to complete the survey. Thank you for your help! QP
Seiche Sanders Editor
William J. Troy
Senior Leadership Andrew Baines Michael Barry Lynelle Korte Brian J. LeHouillier Lindsey Linder Laurel Nelson-Rowe
To promote discussion of issues in the field of quality and ensure coverage of all responsible points of view, Quality Progress publishes articles representing conflicting and minority views. Opinions expressed are those of the authors and not necessarily of ASQ or Quality Progress. Use of the ASQ logo in advertisements does not necessarily constitute endorsement of that particular product or service by ASQ.
July 2015 • QP
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-
Otin Presley Meggisson
I would add a quality engineer compe-
tent in each respective discipline (process, mechanical, civil/structural, instrumentation and electrical) to the respective
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
“It’s in quality” many departments outside
to respond to positive reviews, as well as
the quality department reject.
negative ones. Andrew Cox
Rio Rancho, NM
Great idea from ‘One Good Idea’
I used the table in “One Good Idea: The
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
an actual exercise. Nikki Swopes
QP • www.qualityprogress.com
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 world’s 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 [email protected]
www.facebook.com/ groups/43461176682 www.linkedin.com/groups/qualityprogress-magazine-asq-1878386
ONLINE [email protected]
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 [email protected]
or comment on the article’s webpage. Your comments could appear in an upcoming edition of LogOn.
Stephen K. Hacker, Transformation Systems International, LLC
Cecilia Kimberlin, Kimberlin LLC (retired – Abbott)
Patricia La Londe, CareFusion
Eric Hayler, BMW Manufacturing
QUICK POLL RESULTS
Each month at www.qualityprogress.com, visitors can take an informal survey. Here are the numbers from last month‘s Quick Poll:
William J. Troy, ASQ
PARLIAMENTARIAN Sue Campbell, ASQ
DIRECTORS What efforts most enhance an organization’s culture? 4.6% 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. Gabaldón, 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, Escritório de Engenharia G. Geoffrey Vining, Virginia Tech, Department of Statistics
QP EDITORIAL REVIEW BOARD Randy Brull, chair
Recent headlines from ASQ’s 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 Joes—the people who actually buy iPhones—can 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
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 management—such 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
sis—have direct application in innovation.
Each phase has two essential steps.
marketing side of the organization—they
However, there are additional tools—in-
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, it’s important that marketing and
ing—available 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 it’s what quality professionals
tion. This is where the quality profession
speed of change in today’s 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
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 customer’s 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
QP • www.qualityprogress.com
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 time—it
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 system—and that’s 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
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
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 process—Baldrige criteria,
Can you switch from a variable plan (Z1.9) to an attribute plan (Z1.4) for your inspection to align with your supplier’s use of Z1.4? Though I do not believe harmonizing with the supplier’s use of Z1.4
REFERENCE AND NOTES 1. Use the ASQ Innovation Division’s 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
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
Don’t 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,
competition and economy and finding
A: The ANSI/ASQ Z1.4 standard is for in-
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 [email protected]
, and our subject matter experts will help you find a solution.
July 2015 • QP
QUALITY COUNCIL OF INDIANA CQIA PRIMER
PRIMERS New CBA
Our Primers contain study material for the current ASQ bodies of knowledge plus sample questions and answers. The Primers may be taken into the exam. The completeness of our materials makes them the most widely used texts for Certiﬁcation Training.
Quality Council of Indiana offers detailed solutions to all questions presented in the corresponding Primer.
QCI offers user-friendly interactive software to assist students preparing for ASQ examinations. Each CD contains 1000 total questions. Examinations are timed and summarized graphically. A help ﬁle provides explanations and references. The CDs run on Windows XP and newer.
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Juran’s Quality Handbook by Juran & De Feo The essential quality reference for most ASQ exams En Español
Implementing Six Sigma by Forrest W. Breyfogle, III A great CSSBB reference
by Wortman & Richardson The lastest ASQ exam.
Spanish Green Belt
The Spanish version of the CSSGB Primer.
by Tracy Omdahl
More than 2500 deﬁnitions. Great for any ASQ certiﬁcation.
LSS Primer The Lean Six Sigma Primer is written to a QCI BoK. There are more case studies and lean content than in any other QCI products. 400 questions are included. A solution text is also available.
by Tracy Omdahl
Contains 2800 deﬁnitions. Helpful for Reliability and Quality Engineers.
ISO 9001 Internal Auditing Primer
ISO Primer by Bensley & Wortman
by Greg Wies & Bert Scali
A convenient book for training internal auditors to the ISO 9001 expectations. An instructor CD is available.
Reliability & Maintenance Analyst CD by Bryan Dodson
Solve your Weibull, reliability, warranty, Bayesian & Maintenance, prediction & estimation problems.
Measurement Analyst CD Performs all measurements required in the AIAG manual. Contains ANOVA methods and excellent graphs. Site and global license available!!!
Used by Chrysler, ITT, FedEx, Ford, TRW, GM, HP, U.S. Postal Service
Presents a thorough treatment of the ISO implementation and documentation process. There are generic manuals on the CD.
Quality System Handbook by Edenborough
Details the selection, organization, and writing of quality documents. The disk contains procedures and work instructions.
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
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
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-
worldwide—the largest auto recall
form—its 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
hasn’t 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
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
the risks of a growing trend within the
The adoption of global platforms means
auto industry among others—globaliza-
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 don’t have to do everything for each vehicle, you can
NAME: Minda Chiang.
Who’s Who in
RESIDENCE: Hong Kong. EDUCATION: Master’s 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 scale—I’m 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 Kong’s first sterile-injection production line, which met the health department’s 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 ASQ’s 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 can’t 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.
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
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-
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 Architectures—But 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, “Toyota’s 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: VW’s 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
14 QP • www.qualityprogress.com
ASQ TEAM EXCELLENCE AWARDS
ARGENTINIAN TEAM REACHES GOLD STATUS Argentina’s Movistar-Telefónica de Argentina “Weaving a Quality Network” team was awarded gold-level status at ASQ’s International Team Excellence Awards after showcasing how it improved its organization’s quality and efficiency. ASQ announced the achievement—along with other winners—at its World Conference on Quality and Improvement in Nashville, TN, which was attended by nearly 3,000 people, the conference’s largest attendance since 2000. In the award’s 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: • Alcoa—Power and Propulsion, “APP Process Management” team, Whitehall, MI. • BNY Mellon International Operations Private Ltd., GAMO, Pune, ARGENTINA’S MOVISTAR-TELEFÓNICA de Argentina “Weaving a Maharashtra, India. Quality Network” team celebrates achieving gold-level status at • Movistar—Telefónica de Argentina “You Can Do It!” team, ASQ’s 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 Program’s 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.
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 Technology’s 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 center’s 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 ASQ’s Grant and Lancaster awards in 1987 and 1996, respectively, its Edwards Medal in 1993 and its Distinguished Service Medal in 2001. For more about Hromi’s 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 [email protected]
Nominations are due by Oct. 1. INSPECTION CONFERENCE SET ASQ’s 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 ASQ’s 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 ASQ’s Nightingale Scholarship.
29TH SALARY SURVEY OPENS QP’s 29th annual salary survey is being conducted the entire month of July. Visit www. qualityprogress.com and follow the link to take this year’s 10-minute survey. Results will be published in December’s QP.
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
16 QP • www.qualityprogress.com
weren’t 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.
STANDARDS CHANNEL ADDS 4 NEW VIDEOS TO COLLECTION The ASQ Standards Channel has released four new
revision. More bundles of videos are scheduled to
videos—this time interviews with experts discuss-
be unveiled in the coming months as the revision’s
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.
year—already 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 ASQ’s 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 SSFM’s 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
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 (Gilbreth’s term) to a surgeon by handing surgical instruments to the surgeon as called for. Gilbreth’s 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 9001:2015—including those related to new definitions and requirements—will certainly affect how individual sectors, such as automotive, aerospace and medical devices, handle upcoming revisions to their own guidance documents.
EDITOR’S NOTE: This article was ﬁnalized before the ISO 9001 ﬁnal 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.
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by Author Name
In 50 Words Or Less
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QP • www.qualityprogress.com
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July 2015 • QP 19
Some sector-specific documents were already cre-
The words “procedure” and “record” are not in-
ated by that time—for 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-
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 it’s 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 ISO’s 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 ISO’s
national standard (FDIS, which is now optional), and
best-selling standards,” and they “give a base-level con-
finally the document’s release as an international stan-
fidence in an organization’s ability to provide conform-
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 chains—at 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
ISO standards in clause 3, which are the terms and defi-
20 QP • www.qualityprogress.com
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 term’s
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-
dards—for example, 1987 and 1994—offered a QMS
dence in the organization’s 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 organization—not
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 organization’s 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
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 standard—ISO 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
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 organization’s context,
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 methods—for 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
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 organization’s 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 organization’s 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
ganization’s 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 10.2.1—Nonconformity and Corrective
organizations “shall consider,” so organizations must
Action, and DIS Clause 8.7—Handling 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 apply—for 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
22 QP • www.qualityprogress.com
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 Overview—Quality 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 Beyond—Preparing 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 Standard—Quality management systems—Requirements. 6. Croft, “ISO 9001:2015 and Beyond—Preparing for the Next 25 Years of Quality Management Standards,” see reference 3. 7. International Organization for Standardization, ISO 9001:2008, Quality management systems—Clause 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 Standard—Quality management systems—Clause 6.1 Actions to Address Risks and Opportunities. 10. International Organization for Standardization, ISO 9001:2015 Draft International Standard—Quality management systems—Clause 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 What’s in their wallets? You know you’re 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 people who take it, the more representative the results will be. To thank you for your participation, at the end of the survey you can enter a drawing to win one of five $50 Amazon gift cards. The survey runs through the entire month of July. We’ll publish the results in our December issue. Remember, the survey is anonymous, and the results are reported in aggregate. But it will let you know what others on your level, in your particular area of expertise, are making on average. Do your part! And thanks!
QP SALARY SURVEY
July 2015 • QP 23
Passion PROJECT by Luke T. Foo In 50 Words Or Less
• A small manufacturer, D’Addario, 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 D’Addario’s improvement efforts.
Manufacturer’s dedicated employees, TQM and quality culture make sweet musical strings
A SMALL MANUFACTURER is producing guitar strings for some of music’s 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 D’Addario and Co., located in Farmingdale, NY, a town with population of a little more than 8,000 people. The organization’s history traces back to the 1600s when the D’Addario 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, D’Addario 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 instrument’s 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
continually increasing customer satisfaction at continu-
4. The quality of the strings.
ally lower costs. It works horizontally across functions
In today’s world of million-dollar instruments, few
and departments, and it involves every employee.2
people would guess that strings—which are relatively in-
TQM stresses learning and adapting to continual
expensive—play such a significant role in sound quality.
change as keys to organizational success, and it includes
My interest in learning how D’Addario was able to
systems, methods and tools.3 This perfectly describes
maintain its status as a world-class operation came from
the philosophy at D’Addario. It was no surprise to learn
my personal avocations of music and musical instru-
that the personnel at D’Addario live and breathe TQM,
ments. I’ve been a quality professional for 20 years, but
and it was evident in my first few minutes of speaking
I’ve 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 D’Addario’s
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 D’Addario’s employees
with members of the organization’s 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 employee’s 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.
In 2007, 12 management personnel were selected to take a year and a half of training in lean Six Sigma. In
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 D’Addario brand well for
versatile by cross training in other departments.
its quality. They describe D’Addario strings as being the
Operators are empowered to make on-the-spot decisions on the manufacturing floor to prevent defects.
DEMING’S 14 POINTS
W. Edwards Deming provided 14 principles for improving an organization’s 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 Deming’s 14 points and Joseph M. Juran’s trilogy. “This isn’t 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 D’Addario was receiving many customer complaints
SOURCE: The W. Edwards Deming Institute, “Theories & Teachings,” www.deming.org/theman/theories/fourteenpoints.
26 QP • www.qualityprogress.com
about missing guitar strings. They are packaged with six strings to a set—each string at a different gauge size.
THE D’ADDARIO MANAGEMENT team from left to right: Liz Crew, Angela Zammit, Brian Johnson, Dan Damon and Fan-Chia Tao. (Photos courtesy of D’Addario 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
D’Addario. Jim is chairman and CEO,
the primary tool used to identify the source of the
and John is vice chairman. Because the
organization is privately held and family
The solution was simple and effective: It reduced
owned, the brothers don’t 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
rather than a missing individual coil. Today, D’Addario
THE PRINCIPAL OWNERS of D’Addario and Co., John (left) and Jim D’Addario.
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 Deming’s 14 points (see the sidebar “Deming’s 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
floor have been custom built, costing millions of dollars,
the ball is to help anchor the string to the saddle end of
and the organization’s lean manufacturing largely relies
the stringed instrument.
on automation that helps save jobs. D’Addario 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
Babylon—where Farmingdale is located—and the state
The three principles of Juran’s quality trilogy are:
of New York contributed funds to assist it in further ex-
1. Quality planning—identifying customer needs.
pansion of the factory to help employ additional staff.5
2. Quality control—measuring performance and
D’Addario isn’t afraid to experiment and invent, and it makes some of world’s best nylon strings for classical guitars. I learned that the development of those strings took more than seven years—and ongoing development continues.
sources of variation. 3. Quality improvement—making breakthrough changes. In one situation, D’Addario implemented the quality trilogy after customers had reported they experienced
“The D’Addario 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 world’s best nylon strings,” Johnson said.
D’Addario 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
D’Addario listened to the customer, experimented with
Jim D’Addario is a musician, as are many of the organiza-
product and process improvements, monitored the
tion’s employees, but it’s 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 D’Addario
is passion before profit, which starts at the top of the organization and trickles down to the every level.
This small organization’s success stems from the strong leadership exhibited by Jim D’Addario 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: “It’s a passion, not a job,” “It’s intensely positive here,” and “Our opinions matter.” These comments speak volumes about the organization’s leadership. Showing that a positive environment leads to long-term stability and job satisfaction, the average employee’s 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 D’Addario’s 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
28 QP • www.qualityprogress.com
REFERENCES AND NOTES 1. Learn more about the history of D’Addario 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. “D’Addario & Company Moves Wire Mill to Farmingdale, NY, Creating Long Island Jobs,” Daddario.com, http://tinyurl.com/daddariojobs. 6. See the back story of D’Addario’s NYXL manufacturing process at www. nyxlstory.com/story.
BIBLIOGRAPHY DeFeo, Joseph A., and William W. Barnard, Juran Institute’s 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 master’s 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.
What’s 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 month’s featured content and more Web exclusives in the ASQ Knowledge Center at asq.org/knowledge-center/featured.html.
The Global Voice of Quality
Turning on the Light Bulb Critical reﬂection 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 reﬂection to embrace new perspectives. • Reﬂective practice methods can help managers ﬂip the switch in employees’ minds and help them understand quality.
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 education—that 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
expectations of the organization in which we work.
Philip B. Crosby’s 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.
ics—it 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.
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 one’s 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 attempted—is 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
32 QP • www.qualityprogress.com
tive transformation about quality:
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-
tions—This approach is based on the theory and ex-
3. Critical incidents discussion—Educator 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.
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 discussions—Most 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 analysis—The 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 organization—with a common set of
cilitator guides the discussion to bring out important
experiences—together to examine their organization
points about meaning perspectives and meaning trans-
from the perspective of a metaphor.
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 It’s 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 exercises—Leah 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
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 department’s staff to work in small groups
Regardless of the specific method employed—
of four or five people—each 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
analysis, fault-tree analysis and other options—the
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
bring out the unstated beliefs that are shared in an organization that may not be at all consistent with the
organization’s 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 analysis—The 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 accomplished—or 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 analysis—As a method, root cause analysis has its origins in the U.S. Navy’s nuclear program, with the insistent expectation for questioning everything that was the hallmark of Admiral Hyman Rickover’s leadership style.16 Most root cause analysis methods were developed by engineers and officers engaged in designing and
34 QP • www.qualityprogress.com
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 ASQ’s Education and Training Board, past chair of the ASQ Energy and Environmental Division, and past chair of ASQ’s Education Division. He has served as a judge for the Malcolm Baldrige National Quality Award Program.
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The Global Voice of Quality
What’s 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 improvement—his system of profound knowledge.2 Deming outlined four elements—appreciation of the system, understanding variation, psychology and the theory of knowledge—which provide insight into how improvement can occur.
July 2015 • QP 37
Completed driver diagram Aim
/ FIGURE 1 Specific change ideas Use assessment of risk tool to identify patients and other factors that may influence patient populations
Provide 90% of high-risk adult and surgical patients with a medication management service at discharge and in the immediate postdischarge period (7 days)
High-risk patient discharge process
Discharge planning processes
Notification process—magnets on patients’ boards (enroll patients), pharmacist
Identify patients at greatest risk of harm and greatest potential for benefits
Collaboration Referral mechanism
Integration and coordination of services with primary care Pharmacist resource
Modify electronic discharge summary (EDS) template to identify high-risk patients
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
A theory of knowledge can be defined as a view
38 QP • www.qualityprogress.com
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 team’s shared
tool derives its name are intended to identify the ele-
theory of knowledge—which is developed by consen-
ments in the system that are necessary and sufficient
sus—and 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
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 system’s 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 improvement—with a direct link to an outcome measurement of interest.
Conceptual view of a driver diagram / FIGURE 2 Outcome
• A timeframe for completion.
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 change ideas Ideas: 1 2 3 4 5 6 7 8 9 · · · · · · · · N
Change concepts Concept 1
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-
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 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
40 QP • www.qualityprogress.com
Specific change ideas Ideas: 1 2 3 4 5 6 7 8 9 · · · · · · · · N
Change concepts Concept 1
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?
Specific ideas, concepts and bundles that could generate the desired state
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 reminder—a specific change idea—will 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-
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-
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
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 idea’s 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
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-
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
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
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-
EDITOR’S NOTE The authors thank Tom Nolan for his original work in the creation of this tool. They also recognize Cincinnati Children’s 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
42 QP • www.qualityprogress.com
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 120 minutes to 90 minutes.
Revised theory of improvement
Aim: A more effective morning management meeting. Reduce time of meeting from 120 minutes to 90 minutes.
Final theory of improvement
Aim: A more effective morning management meeting. Reduce time of meeting from 120 minutes to 90 minutes.
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: 1. Make decisions by voting. 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. 5. Give assignments to prepare for the meeting.
Change ideas: 1. Make decisions by voting. Change ideas: 2. Prepare and use an agenda. 3. Give assignments to prepare for the meeting.
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 master’s 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 master’s 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
/ 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
44 QP • www.qualityprogress.com
This requirement is identified in ISO/IEC 17025 Section 22.214.171.124.2.3 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
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 126.96.36.199.2.
DILIP SHAH is president of E = mc3 Solutions in Medina, OH. He is the past chair of ASQ’s 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.
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The Global Voice of Quality
July 2015 • QP 45
QUALITY IN THE FIRST PERSON
BY T. DAN NELSON
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 didn’t pay close attention to ISO 9001, not having any idea how familiar I’d 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 he’d
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 was—you guessed it—writing
individual requirements of ISO 9001, and
documentation for a company in pursuit
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.
was—you guessed it—writing work in-
Most of the principles of quality man-
a consultant trainee.
structions for another company in pursuit
agement contained in ISO 9000—from
of ISO 9001 certification. I did that for a
which the requirements of ISO 9001 are
few months before I was called back to
derived—are straightforward and don’t
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.
46 QP • www.qualityprogress.com
Nobody at the shop liked the ISO 9001 procedures that were created. They were
actual organizational processes—not the standard’s clauses and subclauses.
Until that time, I thought ISO 9001 required 20 procedures. That’s 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 that’s what everyone else
viewing ISO 9001 incorrectly. Unlike my
tion. Some systems are properly defined
was doing. It wasn’t even a question.
previous training courses, my new em-
by 10 procedures, others by 30. That’s 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 processes—pur-
able for guidance on the standard. None
number of procedures. The approach
suant to plan-do-check-act cycles—rather
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 organization’s QMS
contradicts the standard’s 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
I’ve been using and promoting the
an organization’s 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 ASQ’s 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.
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15-03-09 1:49 PM
July 2015 • QP 47
BY JOSEPH D. CONKLIN
Behind the Interview Curtain Effective interviewing techniques from an experienced manager WHEN MY FRIEND Al—an interview-
Rehearsing the interview
If the job requires writing, bring
ing manager—heard I was applying for
His first suggestion wasn’t 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 you’re seeking. Don’t be
your organization. Bring more than one to
government, starting out as coworkers
over the top—stand out, don’t be ruled
show you communicate well in a variety
and continuing as friends after I moved
of settings and styles. They don’t need to
to another agency. We’re both statisti-
A successful interviewer has stories
be more than a few pages.
cians, but Al is more of an extroverted,
ready that substantiate what’s on his or
Even if there’s not enough time to
people person, and his way with people
her résumé. They should be rehearsed
discuss all the samples, they’re good to
helped him ascend the management
well enough to sound smooth but not
leave behind to remind the interviewer of
memorized. You don’t 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 you’ve written.
benefited him on both sides of inter-
offered these questions:
views. Knowing Al as I do, I trusted he’d
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
applicant’s 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 applicant’s first reference contradicted a claim on his résumé. That’s
impossible and you didn’t
always a no-no. He claimed credit for a
know where to start, what
master’s 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
completed for one professor—not a full
how did you handle the
thesis—and he had not taught the appli-
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
applicant created electronic spreadsheets
Even if you don’t end
to help him run the business, but he
up needing it, bring a copy
couldn’t speak to the applicant’s skills as
of your résumé to demon-
strate you’re organized and
48 QP • www.qualityprogress.com
The right referrals
The third reference was difficult to
prepared—qualities that are
track down. The contact information
always in demand.
provided by the applicant was outdated,
helpful and useful curiosity are:
and he hadn’t worked at the company that
qualifications. As you answer the inter-
was listed for more than a year. Al spent
viewer’s 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?
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
I qualify for?
ability to meet the job’s requirements and
Standing out from other applicants is
4. If I am hired and do well, what other
Al’s final point showed his experience
your challenge. In Al’s experience, appli-
as an actor. He said to not be discouraged
cants didn’t always ask about the impor-
if you don’t 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
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. I’m qualified.
ough study and consideration of the job
2. I’m available.
requirements. Asking about and suggest-
3. I want to fit in.
ing future goals communicates your inter-
The stories you’ve 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 master’s 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.
Real-World Quality Improvement Visit ASQ™ TV’s 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. TRAINING
The Global Voice of Quality
July 2015 • QP 49
October 27-29, 2015
Donald E. Stephens Convention Center Rosemont, IL QualityShow.com
3 GREAT REASONS TO ATTEND
er t s i g e R EE R F r o f Today!
The Quality Show is the only trade show focused exclusively on quality education, technology, equipment and products.
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Exhibit Hall • 15+ hours of exhibit ﬂoor time with exhibitors, spanning 3 days • Over 150 solution providers demonstrating cutting-edge products and technologies in quality management • Explore alternative products/ solutions that are more efﬁcient and cost effective
G ol d S po ns o r
Register Today at
Networking Network with thousands of quality professionals and decision-makers and buyers: • 3 Days and 15 Networking Hours! • Welcome Reception on Day 1 to kick off your show experience • Networking Reception on Day 2 to continue conversations off the show ﬂoor
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
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 = α type I error
True negative = power
Do not reject null hypothesis
True positive = confidence interval
False negative = β 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.
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 α), and it means you’ve found a
and the lower the variability, the higher a
underpowered, the most direct issue that
difference between two groups when re-
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 β). 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
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
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 α and β
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 α = 0.05 and 80%
using investigator-chosen prespecified
tor the minimal detectable effect in the
levels of significance and power. These
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 α = 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-β (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 α and
you have the greatest movement with the
1, this means you may wish to be 90%
β, 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
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 α, a value of 1−β 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 α and β.
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
52 QP • www.qualityprogress.com
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 and—while seldom reported in published results—can be helpful when designing
Underpowered = too small of a sample
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
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
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
significant—but these results may not be
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
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
THREE’S 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 master’s 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 bachelor’s 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
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.
• AS9100—Quality 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
systems—Requirements for aviation,
performing continuing airworthiness
space and defense organizations.
management activities in addition to
• AS9110—Quality management
existing stakeholders, such as MRO
ISO 9001 being published later this year,
systems—Requirements for aviation
and original equipment manufacturers
the IAQG five-year review cycle as well
that provide maintenance services.
as opportunities for improvement. ISO
• AS9115—Quality management
• AS9115. Revisions include adding con-
9001:2015 is scheduled for publication in
systems—Requirements for aviation,
tent to enhance cybersecurity protec-
September, and organizations currently
space and defense organizations—De-
tions for software quality management
certified to it will have a three-year transi-
systems, and recognizing cloud-based
tion period. The goal of the AS9100 series revision
• AS9120—Quality management systems—Requirements for aviation,
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 systems—Avia-
aerospace industry to continuously im-
revised to harmonize with AS9100 and to
tion, space and defense audits isn’t
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-
54 QP • www.qualityprogress.com
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.
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.
Merged current AS9100 series (operation) risk management requirements with the new ISO 9001 requirements on risk-based thinking, which permeates the entire management system.
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.
Introduced in carefully selected areas to establish basic requirements appropriate to the product.
Combined with the operation planning clause to address user interpretation issues.
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 IAQG’s 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, AS9100—Quality management systems—Requirements for aviation, space and defense organizations. 2. International Aerospace Quality Group, AS9110—Quality management systems—Requirements for aviation maintenance organizations. 3. International Aerospace Quality Group, AS9115—Quality management systems—Requirements for aviation, space and defense organizations—Deliverable software. 4. International Aerospace Quality Group, AS9120—Quality management systems—Requirements for aviation, 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 bachelor’s 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 ASQ’s Standards Channel at http://videos.asq.org/asq-standards-channel.
July 2015 • QP 55
Special Advertising Section
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600 N. Plankinton Ave. Milwaukee, WI 53201-3005 Phone: 414-272-8575 www.asq.org ASQ’s training and education puts you and your organization on the fast track to success. Its diverse range of learning topics and delivery methods are second to none. Continue your path toward success with ASQ training. Discover a broad range of course offerings from classroom, virtual, blended and web-based learning. AUDITING • CERTIFICATION • CONTINUING EDUCATION • CONTINUOUS QUALITY IMPROVEMENT • DESIGN OF EXPERIMENTS • ENGINEERING • ENGINEERING MANAGEMENT • ISO 9000 • ISO 14000 • LEAN • MANAGEMENT • METROLOGY • PERFORMANCE IMPROVEMENT • QUALITY ANALYSIS • QUALITY ASSURANCE • QS-9000 SYSTEMS • RELIABILITY • SIX SIGMA • STANDARDS TRAINING • STATISTICAL PROCESS CONTROL • STATISTICAL QUALITY CONTROL • STATISTICS • SUPPLY CHAIN MANAGEMENT • TOTAL QUALITY MANAGEMENT 56 QP • www.qualityprogress.com
In this directory you’ll find information on the educational opportunities that make sense for you right now. Not only will you be helping to ensure your employability, you’ll increase your earning potential and mobility by boosting your workplace credentials. All right, now let’s hit the books!
1200 17th St., Suite 180 Denver, CO 80202 Phone: 303-827-0010 www.bmgi.com and www.bmgi.org BMGI is a global consulting firm providing people-driven solutions to your most pressing business problems—through strategy, innovation, operational excellence and change management. CERTIFICATION • CONTINUING EDUCATION • CONTINUOUS QUALITY IMPROVEMENT • DESIGN OF EXPERIMENTS • LEAN • MANAGEMENT • ONLINE LEARNING • OPERATIONS MANAGEMENT • PERFORMANCE IMPROVEMENT • PROJECT MANAGEMENT • PUBLIC TRAINING • SELFDIRECTED LEARNING • SIX SIGMA • STATISTICAL PROCESS CONTROL • STATISTICAL QUALITY CONTROL • STATISTICS • SUPPLY CHAIN MANAGEMENT • TOTAL QUALITY MANAGEMENT
Special Advertising Section
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The Center for Corporate and Professional Development 204 Schwartz Center Kent, OH 44242 Phone: 330-672-5802 www.kent.edu/yourtrainingpartner The Corporate University 6000 Frank Ave. NW North Canton, OH 44720 Phone: 330-244-3512 www.kent.edu/stark/cucc Kent State University provides lean and Six Sigma training and process improvement consulting services to meet your continuous improvement objectives. Explore the options at www.kent.edu/leansixsigma. CERTIFICATION • CONTINUING EDUCATION • CONTINUOUS QUALITY IMPROVEMENT • DESIGN OF EXPERIMENTS • LEAN • MANAGEMENT • PROJECT MANAGEMENT • PUBLIC TRAINING • SIX SIGMA • STATISTICAL PROCESS CONTROL • STATISTICAL QUALITY CONTROL • STATISTICS • SUPPLY CHAIN MANAGEMENT • TOTAL QUALITY MANAGEMENT
UCSC SILICON VALLEY EXTENSION
2505 Augustine Drive Santa Clara, CA 95054 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. BUSINESS ADMINISTRATION • CONTINUING EDUCATION • ENGINEERING • ENGINEERING MANAGEMENT • ISO 9000 • MANAGEMENT • ONLINE LEARNING • PROJECT MANAGEMENT • QUALITY ASSURACE • TECHNOLOGY
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
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 output—reducing
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
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 Automation’s 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
58 QP • www.qualityprogress.com
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 product’s life cycle
• Email: [email protected]
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 Toledo’s 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: [email protected]
rate of up to 500 per minute. It also can
recalls due to incorrect labeling.
print labels that provide batch or other
• Visit: www.jotautomation.com.
interface for customization and plenty
product-specific information and comply with applicable standards. The system combines a printing mod-
Sick’s 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?
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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 Wijkström 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
control are very important. The authors
them to use the information in an efficient
explore mechanisms developed to create,
and effective manner and giving the book
manage, confirm and deliver trust in com-
an advantage over other publications cov-
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
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 trust—especially if it’s to cross
sustain and improve various processes in
borders. Trust and confidence are explored
turing and quality
in relation to different types of borders or
professionals are tasked with ensuring the
and geographical—as 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-
ability requirements. I found this book to be
Global Supply Chains: Evaluating Regions on an EPIC Framework
It is interesting to note that interna-
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 chapter’s 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
60 QP • www.qualityprogress.com
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,
markets. This chapter discusses six basic
distribution centers and retailers through
Marc A. Feldman
which materials are
functions of higher education: 1. Information dissemination. 2. Directed activities. 3. Feedback and evaluation.
ered to customers.
Innovation in Business Education in Emerging Markets
Ilan Alon, Victoria Jones and John R.
5. Content selection.
chain and reverse
McIntyre, editors, Palgrave Macmillan,
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
recommended for experts in business edu-
within the region are presented. Each coun-
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-
tion in emerging countries.
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.
• 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 ADVERTISER
(operations). Final summaries and conclu-
Quality Council of Indiana
sions listing current and future trends
The Quality Show
complete the authors’ coverage.
July 2015 • QP
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62 QP • www.qualityprogress.com
The Global Voice of Quality
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 Section’s
makes an excellent product, and they use
ers’ motivations and problems. Combine
quality seminar. It’s 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-
short—Customer 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 design—Product excellence
deployed, they can produce products that
ogy enables more sophisticated solutions
comes from an organization’s 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
10. Simplicity is essential—When 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
progress—Your customers’ needs always
analyze product or process simplicity. 11. Self-organizing teams—Techni-
1. Customer satisfaction by rapid
change. You must consistently introduce
delivery of useful products—Customer
new products to meet those needs and be
cal talent can’t 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 product’s value
5. Sustainable, rapid product de-
skills. You need leaders at every level
was in 20% of its features— mirroring the
velopment—Analyze your organization’s
in your organization and training on the
Pareto principle—and 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 circumstances—Anticipate 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 choices—one of which may be start-
ers’ needs provides them instant solutions
and creating easily produced products.
to their problems.
7. Face-to-face conversation is the
Adopting agile principles helped me
best form of communication—Great
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 customer’s 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
er’s, so you should talk it over.
By using quality tools, such as design
validated by data. 2. Welcome changing requirements, even late in development—Customers
8. Projects are built around motivated individuals who should be trusted—The best source of innovative
EDITOR’S 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 master’s 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
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 manufacturer’s 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 product’s population standard
the tube can withstand before it fractures.
Anderson-Darling test—used 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 distribution2—indicated
Data showed the mean UTS for January
normal data sets for January and February.
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 column’s 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
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
fail—the UTS specification was 200 KSI
ing element was failing and needed to be
(+/– 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
One possible cause of the problem was a
to be the tempering process—the 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.
Hypothesis test steps /
opposed to emotions and unsubstantiated
Based on the changes in UTS, hypoth-
would be expected from chance. This allows for an unbiased decision based on statistics and probability, as
2. 3. 4.
The claim Null hypothesis: (H0: µ = 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. α = 0.05 p-value.
KSI = kilopounds per square inch
64 QP • www.qualityprogress.com
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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