Full Issue

QUALITY PROGRESS | SEPTEMBER 2015
Putting Best Practices to Work
www.qualityprogress.com | September 2015
The Ishikawa
Family Legacy
p. 46
QUALITY
IS0 9001:2015
KEEP
CALM
AND
PREPARE FOR
ISO 9001:2015
Let our experts help
Plus:
VOLUME 48/NUMBER 9
How to select
an ISO 9001
consultant p. 8
The Global Voice of Quality
TM
Retool audits
using the Kano
model p. 38
p. 18
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Contents
Putting Best Practices to Work | September 2015 | www.qualityprogress.com
FEATURES
18
STANDARDS
Keep Calm and Prepare for ISO 9001:2015
SOFTWARE QUALITY
A Hard Look at Software Quality
A pilot project proved how the ISO/IEC 25000 family of standards can
be used to evaluate software quality and let developers better address
maintenance issues.
by Moiss Rodrguez, Mario Piattini and Carlos Manuel Fernndez
38
AUDITING
A new approach that incorporates the Kano model can help you
evaluate the performance of your quality audit programs.
HISTORY
Like Father, Like Son
A look back at the lasting contributions Ichiro Ishikawa and

Kaoru Ishikawa made to total quality management and the
world of quality.
by Gregory H. Watson
38
AND
PREPARE FOR
ISO 9001:2015
ONLY @
www.qualityprogress.com
Amazing Audits
by Lance B. Coleman Sr.
46
KEEP
CALM
Standards experts provide basic analyses and map out five key changes
included in ISO 9001:2015 to help make sense of what they mean, what
your organization must do to meet the new requirements, and resources
available to help you navigate the transition.
by Bill Aston, Susan L.K. Briggs, Charles A. Cianfrani, Deann Desai,

Allen Gluck, Paul C. Palmes, Denise Robitaille and John E. Jack West
30
18
Small Business Challenge

A sidebar for this months

cover story (Keep Calm and
Prepare for ISO 9001:2015,
pp. 18-28) examines the resources
that small organizations can use
to help with the transition to
ISO 9001:2015.
More figures to illustrate how

to evaluate your audit programs,
the subject of Amazing Audits,
pp. 38-45.

Audit Add-Ons
Stay in the Loop
Subscribe to the new Standards

Connection enewsletter and stay
on top of the latest ISO 9001:2015
developments.
Back to Basics
Translated into Spanish.
Talk Back
Rate and comment on this months

four feature articles.
QP
DEPARTMENTS
6
LogOn
Expert Answers
12
Advice on developing
high-quality suppliers.
12
QUALITY PROGRESS
Tips on initial ISO 9001

implementation.
Choosing the right ISO 9001
consultant or registrar.
Mail
Quality Progress/ASQ
600 N. Plankinton Ave.
Milwaukee, WI 53203
Telephone
Fax
800-248-1946 414-272-1734
414-272-8575
Keeping Current
Dealing with drones.
Email
14
Mr. Pareto Head
Follow protocol of first initial and full last

name followed by @asq.org (for example,
vellifson@asq.org).
66
QP Toolbox
Article Submissions
68
QP Reviews
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
manuscripts@asq.org.
COLUMNS
5
53
56
Up Front
Stress relief.
Measure for Measure
Updates needed to the occupation

classification list.
Quality in the First Person

Learning early on to always do
things rightnot just when others
are watching.
58
Author Guidelines
58
Career Corner
In job searches, do your homework

on prospective employers.
To learn more about the manuscript review

process, helpful hints before submitting a
manuscript and QPs 2016 editorial planner,
click on Author Guidelines at www.
qualityprogress.com under Tools and
Resources.
60
Statistics Roundtable
Photocopying Authorization
71
One Good Idea
72
Including nuisance factors during

experimentation.
Using fault data spectrums
to check corrective actions.
BONUS
Back to Basics
Are standard certifications always

necessary?
Authorization to photocopy items for

internal or personal use or the internal or
personal use of specific clients is granted by
Quality Progress provided the fee of $1 per
copy is paid to ASQ or the Copyright Clearance Center, 222 Rosewood Drive, Danvers,
MA 01923, 978-750-8400. Copying for other
purposes requires the express permission
of Quality Progress. For permission, write
Quality Progress, PO Box 3005, Milwaukee,
WI 53201-3005, call 414-272-8575 x7406, fax
414-272-1734 or email reprints@asq.org.
Photocopies, Reprints
And Microform
SPECIAL SECTION
ASQS STANDARDS AND
AUDITING GUIDE p. 62
NEXT MONTH
- STRUCTURED DECISION MAKING

A new five-step process to evaluate
and balance competing objectives.
- SUPPLIER DEVELOPMENT
How one energy company uses an automotive

standard to assess and manage its suppliers.
ASQs Vision: By making quality a global priority, an organizational imperative and

a personal ethic, the American Society for Quality becomes the community for everyone
who seeks quality technology, concepts or tools to improve themselves and their world.
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
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Agreement #40030175. Canada Post: Return undeliverables to 2835 Kew Drive, Windsor, ON N8T 3B7. Prices are subject to change without
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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.
QP www.qualityprogress.com
Article photocopies are available from ASQ

at 800-248-1946. To purchase bulk reprints
(more than 100), contact Barbara Mitrovic at
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ProQuest Information and Learning, 300 N.
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www.il.proquest.com.
Membership and Subscriptions
For nearly 70 years, ASQ has been the

worldwide provider of information and learning opportunities related to quality. In addition, ASQ membership offers information,
networking, certification and educational
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to Quality Progress are one of the many
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application on p. 65.
List Rentals
Orders for ASQs member and nonmember

buyer lists can be purchased by contacting
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UPFRONT
QP
QUALITY PROGRESS
Stress Relief
EXECUTIVE EDITOR AND

ASSOCIATE PUBLISHER
Handy primer on the ISO 9001 revision
Mark Edmund
Seiche Sanders
ASSOCIATE EDITOR
ASSISTANT EDITOR
ITS FINALLY HERE: the release of ISO 9001:2015. For months, many have been anx-
Amanda Hankel
iously awaiting this moment and all of the changes that come with it. And though the
MANUSCRIPT COORDINATOR
wait is over, now the clock starts tickingorganizations have three years to transition
their quality management systems (QMS) to the new edition of the standard.
The transition raises many questions, such as: What is the new clause structure and
why? What does it mean to understand your organizations context? And how does
your QMS address risk-based thinking?
Let us help. QP has been covering the revision process and providing information
to help you prepare all along. With the standards release, we went all out to assemble
the best how-to guide available. In Keep Calm and Prepare for ISO 9001:2015, p.
18, eight key experts weigh in on what you need to know about transitioning to the
Valerie Ellifson
COPY EDITOR
Susan E. Daniels
CONTRIBUTING EDITOR
Tyler Gaskill
ART DIRECTOR
Mary Uttech
GRAPHIC DESIGNER
Sandy Wyss
PRODUCTION
standard right now. Share this article with your colleagues, teams and bosses. The
Cathy Milquet
standard may just now be final, but this is when the real work begins.
ADVERTISING PRODUCTION
This months Expert Answers department, p. 8, addresses some other important

questions many have about getting started with ISO 9001 and hiring a consultant or
registrar to transition to the standard.
Also, could your audit program stand to improve? Read Amazing Audits, p. 38, for
some helpful tricks and tools to improve your audits using the Kano model. An evaluation form is provided to produce a ranking that is incorporated into the Kano model
and used to improve internal audit performance.
Barbara Mitrovic
DIGITAL PRODUCTION SPECIALISTS

Julie Stroik
Julie Wagner
MEDIA SALES
Naylor LLC
Lou Brandow
Krys DAntonio
Norbert Musial
MEDIA SALES ADMINISTRATOR

I was listening to a radio segment this week about Chicagos Air and Water Show
and the newscasters were talking about what you couldnt bring to the lakeside event,
including alcohol and pop-up tents. New to the banned list this year: drones. Drones
have the potential to offer great efficiencies and capabilities to organizations, yet as
Kathy Thomas
MARKETING ADMINISTRATOR
Matt Meinholz
EDITORIAL OFFICES
businesses wait for approvals, consumer use of drones speeds along, creating dan-
Phone: 414-272-8575
Fax: 414-272-1734
gerous circumstances in the skies. In July, for instance, forest-firefighting aircraft in
ADVERTISING OFFICES
California were grounded because of drones flying above the blazes. Numerous pilots
Phone: 866-277-5666
have reported drone sightings within airspace near airports. Regulation seems to be
ASQ ADMINISTRATION
lagging. Read more about the scary situation in Drone Dilemma (p. 12). QP
William J. Troy
CEO
Senior Leadership
Andrew Baines
Michael Barry
Lynelle Korte
Brian J. LeHouillier
Lindsey Linder
Laurel Nelson-Rowe
Seiche Sanders
Editor
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.
September 2015 QP
LOGON
Seen&Heard
Helping suppliers improve
next year when an auditor finds that one
In response to Back to Basics: Sufficient
clause everyone else overlooked.
Evidence (August 2015, p. 64): In my ca-
Tom Fessenden
reer as a computer components software
Putting Best Practices to Work
QUALITY PROGRESS | AUGUST 2015
quality engineer, I developed

and used an audit checklist
to identify risks. This created
Cypress, TX
www.qualityprogress.com | August 2015
Driving
Creativity
With DoE
p. 20
QUALITY PROGRESS
CREATIVITY SPARKS INNOVATION
a profile of the prospective

suppliers strengths and
weaknesses. We then worked
with the chosen supplier to
Person: Substandard Training

Plus:
Restaurants
ramp up table-side
technology p. 10
Quality and social
responsibility
cross paths p. 26
VOLUME 48/NUMBER 8
strengthen its weaknesses.
Clearing up
misunderstandings
In response to Quality in the First
Cultivating
Creativity
Organizational
restructuring
to optimize
innovation p. 14
(July 2015, pp. 46-47): Very good

description of a (continuing)
misapplication of the idea of
TM
We also put in place incoming
standardization of quality processes.
inspections and testing as contingency
Even now, I am dismayed at the number of
measures to protect our organization
offerings to help people avoid mistakes in
from the suppliers weaknesses.
interpretation of the new version of the ISO
The results from our inspections and

testing were communicated back to the
supplier to further drive its improvement
9001 standard. If the standard isnt selfevidently clear, it isnt written well.
Certification will require agreement
efforts. The supplier, in turn, communi-
with the auditorso if you need any help
cated its testing results to help identify
at all, you should ask the auditor. Indepen-
any test correlation issues.
dent verifications are fine, but I still believe
As our inspection and test data im-
the market is the best indicator of quality
proved, we reduced, then dropped, our
success. If you satisfy the customers (with
incoming inspections. We only monitored
whatever your system is), you will do better
the final system test results and our
than your competition.
customer feedback to verify acceptable
Steven Cooke
quality and reliability. It was a lot of work,
Charlotte, NC
but it resulted in developing low-cost,

high-quality suppliers.
Jargon included

Duane Briggs
In response to Blank-Slate State (May
Lexington, SC
2015, pp. 50-51): This matches my style

exactly when creating a quality management
Plenty still unknown
system. The only thing I do differently is
Open to Change (July 2015, pp. 18-23)
regarding regulatory vomit. I include this
provided good but incomplete information
jargon so the person being audited will not
on an unknown entity (ISO 9001:2015).
be intimidated when the auditor uses it.
The author has provided a little more light
For example, Show me your procedure for
onto the shadowed outline of this critical
product realization.
subject. I dont think we will really know
Rick Paul
what this new revision is until sometime
Escondido, CA
Tune In
The latest episode of ASQ TV dives
deep into root cause analysis, covering how quality tools helped save
a deteriorating national monument
and the benefits of using the scientific method approach. Watch for
two new episodes this month: one
on standards and auditing (Sept. 8)
and another on ISO
9001:2015 certification (Sept. 29). Visit
http://videos.asq.
org to access the
full video library.
StayConnected
Find the latest news, quips and targeted
content from QP staff.
Executive Editor & Associate

Publisher Seiche Sanders:
@ASQ_Seiche
Associate Editor Mark Edmund:

@ASQ_Mark
Assistant Editor Amanda Hankel:
@ASQ_Amanda
Contributing Editor Tyler Gaskill:
@ASQ_Tyler

editor@asq.org

www.facebook.com/
groups/43461176682
www.linkedin.com/groups/qualityprogress-magazine-asq-1878386
QP
ONLINE
EXTRAS@
QP
QUALITY PROGRESS
www.qualityprogress.com
Videos feature ISO 9001:2015 experts
Most of the authors of this months cover story, Keep Calm and Prepare for ISO
9001:2015 (pp. 18-28), appear on ASQs Standards Channel, where they discuss
key changes in ISO 9001:2015 and offer advice for implementing it. Tune in to watch
informational videos at videos.asq.org/asq-standards-channel.

Dont be a victim
In his Standards Connection enewsletter article, Avoiding Misinterpretation Quicksand,

expert John Guzik clears up potential misunderstandings in the new version of ISO 9001.
Read the article at http://tinyurl.com/iso9001quicksand and subscribe to the enewsletter
at asq.org/standardsconnection.
QUICK POLL RESULTS
Each month at www.qualityprogress.com, visitors can take an informal survey. Here are
the numbers from last months Quick Poll:
What is your organizations biggest barrier to creativity?
9%
40.9%
13.6%
36.3%
A hierarchical structure that isnt

conducive to ideas rising up.
Organizational silos prevent collaboration.
Lack of an innovation strategy.
Large team sizes hinder communication.
Visit www.qualityprogress.com for the latest question:

What gives you the most anxiety about implementing ISO 9001:2015?
Adopting risk-based thinking.
Enhancing leaderships role in quality.
Defining the context of your organization.
Dealing with documentation.
Understanding the new clause structure.
QualityNewsTODAY
Recent headlines from ASQs global news service

(All URLs case sensitive)
First 3-D-Printed Drug Approved by FDA

3-D printing allows the pill to deliver a higher dosage of medicineup to 1,000 milligramswhile being porous enough to dissolve quickly. These attributes can particularly
benefit patients who have difficulty swallowing their medication and miss doses of treatment. (http://tinyurl.com/3ddrug)
New Breed of Software Engineers Join Automotive Industry
To cope with the software engineer shortage in the automotive industry, suppliers such
as Visteon Corp. are turning to unconventional sourcessuch as the movie and video
game industriesto recruit people. (http://tinyurl.com/autosofteng)
PAST CHAIR
Stephen K. Hacker, Transformation Systems

International, LLC
CHAIR
Cecilia Kimberlin, Kimberlin LLC (retired Abbott)
CHAIR-ELECT
Patricia La Londe, CareFusion
TREASURER
Eric Hayler, BMW Manufacturing
SECRETARY
William J. Troy, ASQ
PARLIAMENTARIAN
Sue Campbell, ASQ
DIRECTORS
Donald Brecken, Ferris State University

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

Randy Brull, chair
Administrative Committee
Brady Boggs, Randy Brull, Jane Campanizzi,

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

David Burger, Bernie Carpenter, L.N. Prabhu
Chandrasekaran, Ken Cogan, Linda Cubalchini-Travis, Ahmad Elshennawy, Mark Gavoor, Kunita Gear,
Daniel Gold, T. Gourishankar, Roberto Guzman,
Ellen Hardy, Lynne Hare, Ray Klotz, Tom Kubiak,
William LaFollette, Pradip Mehta, Larry Picciano,
Gene Placzkowski, Tony Polito, Peter Pylipow,
Imran Ahmad Rana, John Richards, James Rooney,
Brian Scullin, Amitava Sengupta, Mohit Sharma,
A.V. Srinivas, Joe Tunner, Manu Vora, Keith
Wagoner, Jack Westfall, Doron Zilbershtein
WANT THE LATEST QUALITY-RELATED NEWS AND ANALYSIS? The QNT Weekly
enewsletter, available exclusively to ASQ members, delivers it every Friday.
Subscribe now at http://email.asq.org/subscribe/qntwk.
September 2015 QP
EXPERTANSWE
Business success with ISO 9001
tion. Often, organizations dont account for
Selecting consultants, registrars
Q: If an organization wants to implement ISO

9001 for the first time, what is the first step?
these costs because they are less likely to
Q: What are the qualities to look for when
get caught by a regulatory body. This isnt
selecting an ISO 9001 consultant and
a sustainable business practice, however,
registrar?
A: Use the organizations purpose as a
because when it comes time to pay for
starting point. Too often, organizations try
one of these expenses, the money needed
A: This question is timely because the
to appease or conquer requirements as
hasnt been accounted for in the budget or
ISO 9001 and ISO 14001 revisions are
if the end-goal is to satisfy those require-
pricing structure.
scheduled to be released in September
ments.
After you have accounted for everything
2015. Many organizations planning to
to run your business, think in terms of
use external-expert help in implementing
primary purpose (for example, to make
planning to succeed. Risk-based thinking,
their management systems and that are
money through the product or service
management review and data analysis are
planning to find a registrar to register their
offered or to effectively use the available
great for this because they are intended
management systems will find this answer
resources to promote educational excel-
to help you assess actions already taken
useful. This is an important question
lence) means the organization may create
to determine whether further action is
because choosing the right consultant is
a competition between the requirements,
needed. In essence, the organization is
critical to accomplishing organizational ob-
such as those in ISO 9001, and its organiza-
either already suitably established, ad-
jectives on time and on budget. Choosing
tional purpose.
equately addresses all requirements, and
the right registrar is even more important
is effectively driving behavior, or it has the
because you likely will stay with the same
information and action plan to get there.
registrar for several years to come.
cused on what is important without getting
Q: How should an organization approach ISO
Choosing a consultant
lost in the euphoria of becoming certified to
9001:2015 to make it work for its business?
ISO 10019:2005 defines a quality manage-
Not staying true to the organizations
Using who you are as a business as the

reference point for implementing requirements will help the organization stay fo-
ment system (QMS) consultant as a per-
ISO 9001.
A: Look at the standard through the eyes of
son who assists the organization on QMS
Q: How do you determine what is nec-
the business instead of trying to make the
realization, giving advice or information.1
essary for a business to continue to be
business fit the standard. In other words,
This standard further recommends the
successful in the future? How can ISO
many organizations usually take the stan-
following attributes be considered when
9001:2015 be helpful in doing this?
dard and go through it clause by clause. To
selecting QMS consultants:
see the standard from a business perspective, lay out the organization as it functions,
tributes recommended by the standard,
function as a business (organization) to
and plug in the standards clauses where
being ethical is a key attribute. An unethi-
make money or receive funding today.
they apply to the organization.
cal consultant can cause more damage to
After you understand this, you can evaluate

the true cost of sustaining this.
This may mean a clause is accounted
the organization than an incompetent
for in more than one place in the docu-
consultant. Organizations should check the
mented system. That is actually a good
consultants past projects with clients to
facilities, materials and labor to produce
thing because you are dealing with the
ensure there isnt any unfavorable feedback.
your product or service, dont forget about
organizations reality instead of simply ap-
Other personal attributes to look for include:
less-frequent expenses, such as main-
peasing the standard.
observant, perceptive, versatile, tenacious,
While some costs are obvious, such as
tenance costs, licenses or certifications

required to do business, and any other
costs related to sustaining the organiza-
Ethics. Among the many personal at-
A: Start by considering what it takes to
Robert Freeman
President, Practical Perspectives
McKinney, TX
decisive, self-reliant, communicative, practical, accountable and facilitative.

Experience. The consultant should be
RS
Look at the standard through the eyes of the
business instead of trying to make the business
fit the standard.
able to understand the organizations
knowledge and overall work experience,
organization operates and your customer
context and situation and provide creative
including previous roles in quality and
prefers. Most importantly, your registrar
solutions. This comes from experience
operations management.
should have local auditors who have
in working with different-sized organiza-
solid industry knowledge and experience
tions, in various industry segments and
Choosing a registrar
in addition to proven audit experience.
geographic locations, and on projects with
Organizations do not frequently change
If they must send auditors to you from
varying complexity such as providing low-
registrars, so selecting one requires a care-
other regions and geographies to meet
cost, high-value solutions for resource-
ful review. Knowledgeable customers care
auditor skill requirements, it will cost the
constrained small business clients.
about who issued your QMS certification,
organization hefty travel and administra-
so it is important to consider the registrars
tive expenses year after year.
Education and knowledge. The

consultant should not only have the right
reputation. Reputation of an organization is
level of education, he or she also should
often an indirect measure of the quality of
quality of the registrars audit and the
have the necessary skills to understand
its products and services over time.
value added to the organization.
products and services. They should have
If your organization has several locations
Ask customer references about the
Finally, consider overall audit cost. Ask
knowledge of all the relevant management
in a country or around the world, ensure
for the cost breakdown to understand the
systems standards and other international
that the registrar has branches and a global
typical estimated cost for an audit cycle
standards required to implement the sys-
presence to support your needs. If your
(typically three years). This should include
tem well. Examples include sector-specific,
organization plans to become certified to
details such as the audit fee, annual file
accreditation and product standards, as
additional management systems stan-
maintenance, audit cancellation fee, annual
well as safety-related standards.
dards, such as ISO 14001, OHSAS 18001 or
escalation fee and auditor travel expenses.
The consultant should have expertise
industry standards, ensure that the registrar
The registrar should be responsive to the
or working-level experience in project
carries these certifications and that the
clients needs and provide flexibility with
management and quality management
auditors are qualified to audit to multiple
scheduling audits. It may be a good idea to
principles, methods and techniques.
standards. This will allow you to conduct an
ask the shortlisted registrar to conduct a
Implementing the project may require the
integrated management systems audit with
pre-assessment to verify its capability be-
use of quality engineering tools, statistical
the help of a single registrar.
fore committing to a long-term relationship.
techniques, problem solving, risk management and change management.

Other aspects to consider are industry
The registrars accreditation body also
Govind Ramu
matters. Find out if the accreditation body
Director, quality assurance
is recognized in the regions where your
SunPower Corp.
San Jose, CA
AT YOUR SERVICE
Let QPs subject matter experts help you solve your toughest quality-related
problems. Simply submit your question at www.qualityprogress.com, or send it to
editor@asq.org, and we will find an answer for you.
REFERENCE
1. International Organization for Standardization, ISO
10019:2005Guidelines for the selection of quality management system consultants and use of their services.
September 2015 QP
QUALITY COUNCIL OF INDIANA

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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.
SOLUTION TEXTS
Quality Council of Indiana offers detailed solutions to all

questions presented in the corresponding Primer.
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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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PRIMER
QUALITY COUNCIL OF INDIANA
Jurans Quality Handbook

by Juran & De Feo
The essential quality reference
for most ASQ exams
En Espaol
CSSGB
PRIMER
Implementing Six Sigma

by Forrest W. Breyfogle, III
A great CSSBB reference
CSSYB Primer
by Wortman & Richardson

The lastest ASQ exam.
Spanish
Green Belt
Quality
Dictionary
The Spanish version of the

CSSGB Primer.
by Tracy Omdahl
More than 2500 definitions.

Great for any ASQ certification.
RAM
Dictionary
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
ISO
Presents a thorough treatment

of the ISO implementation and
documentation process.
There are generic manuals on
the CD.
Quality System
Handbook
by Edenborough
QSH
Details the selection,

organization, and writing
of quality documents.
The disk contains
procedures and work
instructions.
KEEPINGCURRE
TECHNOLOGY
Drone Dilemma?
Opportunities abound, but safety concerns have some looking for more regulations
Since Amazon made a splash a few years
Farmers want to operate them to moni-
authorities, such as police, firefighters and
ago with plans to incorporate unmanned
tor crops and tailor their use of pesticides,
other first responders, also are expected to
aircraft systems (UAS) into its package
herbicides, fertilizers and other applications.
invest in the technology.5
delivery service, all sorts of industries have
Utilities are considering them to inspect
been abuzz about drones and brainstorm-
electric and gas lines in remote areas.
ing innovative ways to use this burgeoning

technology.
To me, the diversity of industries that
Addressing safety concerns

Along with the excitement and enthusiasm
are coming forward in this initial phase [of
over drones, concerns about aviation safety
applying for FAA special permits] and saying
surrounding this advancing technology
ing too fast for the U.S. Federal Aviation Ad-
wed like to fly using [drones] is the most sig-
persist.
ministration (FAA) to keep up with concerns
nificant element, said Brian Wynne, CEO of
over safety?
the Association for Unmanned Vehicle Sys-
amples of disruptive drone activity:
tems International, a trade group. We think
Pilots at New Yorks John F. Kennedy In-
But is interest and usage in drones mov-
The FAA has to act and toughen up the
Consider just a couple of recent ex-
rules before a tragedy occurs, be-
ternational Airport reported four
cause if a drone were sucked into
drone sightings within a three-
a jet engine of a plane filled with
day stretch in late July and early
passengers, untold tragedy could
August. Other reports of near
result, and we do not, do not, do
collisions between drones and
not want that to happen, said Sen.
airplanes have been reported in
Charles Schumer, D-N.Y., a law-
Austin, TX, and Minneapolis in
maker who wants the FAA to speed
recent months. FAA rules pro-
efforts to update regulations and

close loopholes covering the use of drones.1
hibit drones from flying within

theres a ready-made market out there.3
After the FAA establishes the guidelines
five miles of an airport and no higher

than 400 feet.6
High commercial interest
for commercial use, the drone industry said
Already, the FAA has granted special permits
it expects more than 100,000 jobs to be
above flames and smoke from the for-
while it develops comprehensive rules to
created and nearly half a billion dollars in
est fires in July in California, forcing fire
govern how commercial drones should share
tax revenue to be generated collectively by
crews to ground water-dropping aircraft.
the sky with passenger planes. Proposed
2025.4
The delays allowed the fires to spread,
Unmanned devices were spotted flying
rules for commercial drones were released
Its also predicted that drone activity
resulting in devastating property losses.7
in February, and officials are now reviewing
could be worth tens of billions of dollars
FAA spokeswoman Elizabeth Isham Cory
thousands of public comments that were
to U.S. companies over the next decade as
said the agency receives about 60 reports
submitted. The FAA has granted 944 com-
demand for this technology rises. Organi-
from pilots each month alerting the agency
mercial drone permits as of July 28with
zations are expected to spend money on
of drones flying too close to airports, air-
thousands more applications pending.2
drones to use for surveillance activities,
planes or helicopters.8
For instance, real estate businesses want
agriculture, weather and environmental
Some state and federal-level lawmak-
to use commercial drones to showcase
monitoring, oil and gas exploration, and
ers, as well as private companies, are
properties with videos taken from the air.
aerial imaging and mapping. Government
looking to take action to protect the skies
12 QP www.qualityprogress.com
NT
and further regulate drones:
State: Proposed state legislation in California
would allow firefighters and law enforcement
personnel to take down drones hindering emergency operations. The proposed law would give
firefighters and other first responders immunity
if they damage drones that are interfering during a fire or other emergency. Another piece of
legislation would make it a misdemeanor to fly
a drone over a forest fire. Drone operators could
face up to $2,000 in fines.9
Federal: In addition to the FAA finalizing
guidelines around commercial drones, a big
piece of legislation in Washington, D.C., the
Consumer Drone Safety Act, would address
concerns around consumer, or recreational,
Whos Who in
NAME: Himanshu Trivedi.
RESIDENCE: Ahmedabad, India.
EDUCATION: Doctorate from the Birla Institute of Technology and Science in Pilani,
India.
INTRODUCTION TO QUALITY: Trivedi learned from his parents
and teachers at CN Vidyalaya school in Gujarat, India, that
quality is to achieve perfection. He was formally introduced to
quality by professors at Shantilal Shah Engineering College in
Gujarat, India, and the Birla Institute of Technology and Science
in Pilani, as well as his doctoral guide. While working at Crompton Greaves and Bosch Rexroth, his mentors also guided him to
explore different aspects of quality management.
drones. The act would create federal regulations
CURRENT JOB: Vice president and technical plant manager at Bosch Rexroth India.
regarding when, where and how consumer
PREVIOUS JOBS: Responsible for quality management and methods at Bosch

Rexroth in India and South East Asia Pacific. He was also responsible for Bosch
Production Systems (lean), and health safety and environment at Bosch Rexroth
India. When he worked at Crompton Greaves, he learned about the planning and
operational aspects of quality management. Also, working in an international environment at Bosch Rexroth further enhanced his understanding of quality not only as
operational, but also as strategic and cultural.
drones can be operated, while requiring new

safety technologies be built into all new drones.
This includes collision-avoidance technology, transponders that signal a drones location
to air traffic controllers and other aircraft, and
geo-fencingtechnology that creates a virtual
global-positioning system fence around no-fly
zones that would prevent drones from entering
areas near airports or other restricted airspace.
The bill also calls for anti-tampering safeguards
that would prevent users from modifying consumer drones after they are purchased.10
Private companies: Amazon, too, has proposed a blueprint for a low-altitude air-traffic system, said Gur Kimchi, a vice president who heads
the companys drone-delivery division. Trafficking
the skies is essential before the worlds largest
online retailer can revolutionize how packages
are delivered using drones, he said.11
The only way drones can dart across the skies
ASQ ACTIVITIES: Trivedi has been an ASQ member since 2001 and helped establish
ASQs Ahmedabad local member community in 2010 when ASQ India started its
operation. Since then, he has served as chair of the ASQ Ahmedabad chapter and
has been actively involved in spreading quality knowledge.
OTHER ACTIVITIES/ACHIEVEMENTS: Nominated as member of the board of
studies for a few institutes in Ahmedabad. Awarded Fellow of the National Center
of Quality Management, India. Senior member of the Indian Institute of Industrial
Engineers, India.
PUBLICATIONS: Co-editor of Quality Management for Zero Defect and Zero Effect
(ASQ India, 2014). Authored, co-authored and presented several papers at referred
journals, and national and international conferences.
RECENT HONORS: Elected to ASQs 2014 class of Fellows. Named one of 40 New
Voices of Quality by QP in 2011. ASQ-certified manager of quality/organizational
excellence.
PERSONAL: Wife, Dhara; daughter, Isha; and son, Jignasu.
without hitting each other or threatening tradi-
FAVORITE WAYS TO RELAX: Reading and spending time with family.
tional aircraft is by requiring the equivalence of
QUALITY QUOTE: Quality is creating the right mindset and passionately working
toward excellence through a proactive approach and effective systems.
flight plans to be filed and ensuring that drones

(continues on p. 14)
September 2015 QP 13
KEEPINGCURRENT
Mr. Pareto Head
BY MIKE CROSSEN
Dealing with drones (continued from p. 13)

communicate their positions to a centralized
REFERENCES
computer system available to all operators, ac-
1. Sullenberger: Drone Aircraft a Grave Threat to

Aviation Safety, Aug. 3, 2015, CBS-DC, http://
tinyurl.com/drone-safety-threat.
2. Bart Jansen, Study Finds Showcasing Real Estate
Most Popular Business Use for Drones, USA
Today, July 31, 2015, http://tinyurl.com/moredrone-uses.
3. Ibid.
4. Christopher Doering, Growing Use of Drones
Poised to Transform Agriculture, USA Today,
March 23, 2014, http://tinyurl.com/agriculturaldrones.
5. Clay Dillow, What is the Drone Industry Really
Worth? Fortune, March 12, 2013, http://fortune.
com/2013/03/12/what-is-the-drone-industryreally-worth.
6. Sullenberger: Drone Aircraft a Grave Threat to
Aviation Safety, see reference 1.
7. Matt Hamilton and Veronica Rocha, $75,000 in
Rewards Offered to Catch Operators Who Flew
Drones Above Fires, Los Angeles Times, July 28,
2015, http://tinyurl.com/drones-over-fires.
8. Nick Ferraro, Drone, Airliner in Close Encounter
Near Twin Cities Airport, St. Paul Pioneer Press,
Aug. 5, 2015, http://tinyurl.com/twin-citiesdrones.
9. Matt OBrien, Drone Traffic Control? NASA, Amazon and Google Partner to Manage Self-Driving
Swarms, San Jose Mercury News, July 28, 2015,
http://tinyurl.com/amazon-google-drones.
10. Clay Dillow, Is Congress New Drone Safety
Act an Innovation Killer? Fortune, June 23, 2015,
http://fortune.com/2015/06/23/congress-dronesafety.
11. Alan Levin, Amazon Envisions Distinct Drone
Zones for Future Delivery Fleet, Bloomberg
Business News, http://tinyurl.com/amazon-fleetplans.
12. Ibid.
13. Ibid.
14. Grant Gross, U.S. to Begin Talks on Drone Privacy Standards, PC World, July 13, 2015, http://
tinyurl.com/drone-privacy-standards.
cording to Kimchi.12
Its completely doable, Kimchi said. We can
only be safe and efficient if everybody else is
safe and efficient.
13
Privacy and quality of life

Aside from the concerns about collisions, some
drone doubters bring up privacy and quality of life
issues, envisioning swarms of drones interrupting
sunsets while delivering packages or swooping
across backyards to snap photos of unsuspecting
sunbathers.
Those concerns have the U.S. National
Telecommunication and Information Administration hosting discussions on developing voluntary
privacy standards for drones.
From enhancing news gathering, improving agribusiness and equipping new delivery
models, to providing internet in remote areas,
the possibilities for UAS are staggering, said
Angela Simpson, the agencys deputy assistant
secretary for communications and information.
Consumer trust and responsible operation are
keys to fully tapping the transformative potential
of unmanned aircraft.14
compiled by Mark Edmund,

associate editor
ASQNEWS
UPCOMING DIVISION EVENTS Three
September and October conferences are
being organized by ASQ divisions. ASQs
Inspection Division will host its annual
conference Sept. 10-11 in Dayton, OH.
Visit http://asq.org/inspect for more
details ASQs Biomedical Division is planning its Design DoJo: Keeping Design
Controls Practical and Compliant conference Sept. 29-30 in Boulder, CO. Go
to http://asq.org/biomed for information
on the event. Finally, the second annual
Joint Technical Communities Conferencewhich involves 10 ASQ divisions
will be held Oct. 22-23 in Orlando, FL.
Visit http://asqtcconference.com.
NEW CASE STUDY ASQs Knowledge
Center has released a new case study
about a team at a medical facility in
Dubai that uses the find-organize-clarifyunderstand-select (FOCUS)/plan-docheck-act (PDCA) model to determine
root causes of unreported medication
errors and identify potential improvements. Read the case study at http://tiny.
cc/dubai-asq-case-study.
HEALTHCARE
ASQ JOURNAL SPOTLIGHT

QP occasionally highlights an open-access article from one of ASQs
seven other journals.
This month, read Finding Threats and Hazards Simultaneously in
the Concept Phase of System Development, which appeared in the
June edition of the Software Quality Professional
(SQP).
Author Masao Ito focuses on finding hazards
and threats to assure system safety and security.
He uses the item sketch and goal model and applies guidewords.
Masao also uses standards and the example
of the automobile for explanation purposes, but
thinks this method applies to various domains.
To access the 10-page article in PDF format, click on the Current
Issue link on SQPs webpage at http://asq.org/pub/sqp. From there,
you also can find a link to information about subscribing to the quarterly
publication.
Software Quality
Professional
V O L U M E
S E V E N T E E N
I S S U E
T H R E E
J U N E
2 015
Implementing Functional Safety Standards
Richard Messnarz, Christian Kreiner, Andreas Riel,

BernhardSechser, Klaudia Dussa-Ziegert, Risto Nevalainen, and
SergeTichkiewitch
Taking a Fully Integrated Approach to Implementing

Functional Safety According to ISO 26262 Successfully
Serge Tichkiewitch, Andreas Riel, Richard Messnarz, and
Christian Kreiner
A GSN Approach for Risk Management

in Structured Assurance Cases
Xabier Larrucea and Izaskun Santamaria
The AQUA Automotive Sector Skills Alliance: Best

Practice in an Integrated Engineering Approach
Christian Kreiner, Richard Messnarz, Andreas Riel,
SergeTichkiewitch, and Dick Theisens
Finding Threats and Hazards Simultaneously in

the Concept Phase of System Development
Masao Ito
www.asq.org
DATEINQUALITYHISTORY
QP occasionally looks back on an event or person that made a difference
in the history of quality.
Sept. 17, 2013

Eiji Toyoda died at the age of 100 on this date. The well-known industrialist helped propel his familys automobile companyToyota Motor
Corp.into a worldwide force and changed the way automobiles are
made.
Eijis cousin, Kiichiro Toyoda, created the automaker but resigned in
1948. Eiji Toyada became involved in the company and was sent to the
United States in 1950 to study the auto industry and American manufacturing methods. He returned and redesigned Toyotas plants with advanced assembly techniques and machinery.
The unique Toyota management approach had three main objectives: keeping inventory to a minimum through kanban or a just in time
system, ensuring each assembly step is performed correctly the first time,
and reducing the amount of human labor that went into assembling each
vehicle.
In 1967, Toyoda was named president of the automaker. Under his
watch, Toyota sold an all-time high 1.7 million vehicles in Japan and
1.7 million vehicles overseas in 1985, and profits peaked at $2.1 billion.
Toyoda stepped down as chairman of Toyota in 1994 at age 81.
SOURCE: www.notablebiographies.com/St-Tr/Toyoda-Eiji.html (case sensitive).
BALDRIGE RECIPIENTS
SCORE HIGH QUALITY
MEASUREMENTS
Healthcare organizations that received the
Baldrige National Quality Award matched or exceeded the measurements of healthcare quality
and patient experience of their nearby competitors, according to a recent study.
Thirty-four organizations that received the
award were compared with 153 of their competitors located within a 25 to 50-mile radius. Researchers examined data for 39 measurements
that U.S. hospitals publicly report to the Centers
for Medicare and Medicaid Services (CMS).
The patient-experience
results data come from
Hospital Consumer Assessment of Healthcare Providers and Services (HCAHPS)
surveys of patients.
The HCAHPS patient
survey results were the
most significant findings
in this study, wrote Ron
Schulingkamp and John
R. Latham, the research
authors.
Hospitals that used the
(Baldrige Healthcare Criteria
for Performance Excellence, [abbreviated by the
authors as HCPE]) had higher means and lower
standard deviations (indicating a measurable
positive patient experience) than the non-HCPE
hospitals in all 10 measures, the researchers
wrote.
The differences were statistically significant
for nine of those 10 measurements, the authors
wrote, showing there is a definite positive effect on patient experience with the use of the
criteria.
For more on the study, which was featured
in the recent Quality Management Journal
article Healthcare Performance Excellence: A
Comparison of Baldrige Award Recipients and
Competitors, visit http://tinyurl.com/baldrigehealthcare.
KEEPINGCURRENT
SHORTRUNS
will be held in Washington, D.C., on Oct. 1.
Oct. 19-23 in Cincinnati. For more informa-
THE DEADLINE TO submit nominations
For more information about the celebration,
tion about the five-day event, visit www.
for next years Harry S. Hertz Leadership
visit http://tinyurl.com/world-standards-day.
ame.org/cincinnati.
for the long-time leader of the Baldrige
TO MARK WORLD Statistics Day on Oct.
THE ANSI-ASQ National Accreditation
Performance Excellence Program. For more
20, a data visualization competition is be-
Board has become the first accreditation
details about the award, the nomination
ing held by StatisticsView.com and John Wi-
program to offer the new international
process, award criteria and a list of the 11
ley & Sons Ltd. For more information about
featured standards (IFS) Food Store third-
selection committee members, visit www.
the competition, visit www.statisticsviews.
party retail inspection standard in the
baldrigefoundation.org.
com/view/WorldStatsDayComp.html (case
Americas. The IFS Food Store standard is
sensitive).
the only third-party inspection program
Award is Sept. 20. The award is named
THE U.S. CELEBRATION of World Standards
based on ISO/IEC 17020, which is currently
Day, an event that recognizes the critical
THE ASSOCIATION FOR Manufacturing
available from a leading global scheme
role of various stakeholders across the stan-
Excellence (AME) announced the eight key-
owner. For more information about the
dards community, including business lead-
note speakers who will be featured at its
accreditation, visit http://tinyurl.com/food-
ers, industry, academia and government,
annual AME Excellence Inside Conference
store-inspection.
Looking for Your Typ e

QPs 2016 editorial calendar has been released. Now,
were looking for authors to write on these topics:
2016 Quality Progress Editorial Calendar

January
Back to Basics: Best Of Edition
February
Lean and Six Sigma
March
The Multi-Generational Workforce
April
The Cost of Quality
May
Risk
June
Change and Change Management
July
The QP Career Guide
August
Supply Chain and Stakeholders
September Benchmarking
October
Standards and Auditing
November
40 Under 40
December
Salary Survey
If you want to write for a specific issue,

make sure to submit your article three to
six months before the issue date. That
allows time for the article to be reviewed,
revised and prepped for publication.
Dont worry if you miss that deadline. Send
the article anyway. All accepted articles
will be published.
Be sure to visit www.qualityprogress.com
and click on Author
Guidelines at the
bottom of the
page for more
details.
QUALITY PROGRESS
Get Your ASQ Certification

ASQ certification is a cornerstone of your career growth. You immediately establish yourself as a
recognized expert in your field, resulting in promotions, higher salaries, greater demand for your
services, and an advantage over your competition. Invest in your career and your future with an
ASQ certification. Apply for the upcoming December 2015 exam!
Upcoming Application Deadline: October 16, 2015

Exam Date: December 5, 2015
For more information or to apply for an exam, visit asq.org/cert.
TRAINING
CERTIFICATION
CONFERENCES
MEMBERSHIP
PUBLICATIONS
TM
KEEP
CALM
AND
PREPARE FOR
ISO 9001:2015
Eight experts outline key changes
and how to handle them
ISO 9001:2015
REVISIONS OF ISO management systems are often accompanied by

a bit of anxiety. More than 1 million organizations have been certified to ISO
9001:2008, the international quality management system (QMS) standard, and
they now must embark on implementing a revised version to be published later
this month.
Most organizations are on pins and needles: What are the key changes we
must be aware of? When and how should we introduce the required changes?
What resources will we need?
The international technical advisory groups (TAG) to ISO Technical Committee 176, the group responsible for writing ISO 9001, have toiled to achieve
the highest caliber revision. You can imagine how challenging it is to achieve
a consensus among hundreds of individuals in dozens of countries, with multiple languages and cultures. This is why a betteralthough not perfectISO
9001:2015 is on track for finalization.
The following pages are meant to calm your anxieties by helping you to
understand five of the key changes in ISO 9001:2015, what they mean, what you
must do to meet the new requirements and the resources available to you during the transition process.
Certainly, not every change can be fully detailed in this article, and youll
find most of the changes relate to one another. Risk-based thinking, for example, which arguably may be the most impactful change in ISO 9001:2015, is
engrained in several aspects of the standard.
In a perfect world, a revision for an established, internationally accepted
standard such as ISO 9001 should be easier to read, learn and implement. It
should provide noncontroversial, improved tools for quality management.
Although our world is not yet perfect, ISO 9001:2015s new features do provide
promise for improved quality.
Allen Gluck
Editors note: This following article was written by several standards experts before the
release of the final version of ISO 9000:2015. Information presented here was based on the
draft international standard (DIS) and final draft international standard (FDIS) versions
of ISO 9001:2015.
THE PANEL OF EXPERTS

BILL ASTON is managing director of Aston Technical Consulting Services LLC in Kingwood, TX, and worked 40
years in the oil, gas and chemical industries. A senior member of ASQ, Aston is an ASQ-certified quality auditor,
an Exemplar Global-certified quality management system (QMS) auditor and a Professional Evaluation and Certification Board-certified trainer and lead auditor. He is also a voting member of the U.S. Technical Advisory Group
to ISO Technical Committee 176 (TAG 176) and the American Petroleum Institute Quality subcommittee 18.
SUSAN L.K. BRIGGS is a member of the task force in the Joint Technical Coordination Group that wrote Annex
SL and the associated guidance. She is the chair of TAG 207 on environmental management and the convener
of the international working group revising ISO 14001:2015. She has a bachelors degree in natural science
from Harvard University in Cambridge, MA. Briggs is an ASQ-certified quality/organizational excellence manager, auditor and engineer.
CHARLES A. CIANFRANI is a principal consultant for Green Lane Quality Management Services in Green Lane,
PA. An ASQ fellow, Cianfrani is a U.S. expert representative to ISO Technical Committee 176 (ISO/TC 176). He has
an MBA from Drexel University in Philadelphia and a masters degree in applied statistics from Villanova University in Pennsylvania. Cianfrani has implemented ISO 9001-compliant processes on six continents.
DEANN DESAI is a project manager for Georgia Techs Enterprise Innovation Institute in Atlanta. She has a
masters degree in statistics and polymers from the Georgia Institute of Technology in Atlanta. An ASQ member,
Desai is an Exemplar Global-certified QMS lead auditor, energy management lead auditor and environmental
management systems lead auditor. Desai is a member of multiple ISO standards committees, including TAG 176
and the task force in the Joint Technical Coordination Group that wrote Annex SL and the associated guidance.
ALLEN GLUCK is president of ERM31000 Training and Consulting in Spring Valley, NY, and an adjunct professor
at Manhattanville School of Business in Purchase, NY. He has a masters degree in leadership from Bellevue
University in Nebraska. Gluck is an ASQ member and a member of TAG 176, which develops ISO 9001, and TAG
262, which develops ISO 31000.
PAUL PALMES is president and principal consultant with Business Systems Architects Inc. in Fargo, ND, and
Prescott, WI. He is a member of TAG 176 and chair of international ISO/TC 176, subcommittee 1, responsible for
the revision of ISO 9000. He has been international ISO/TC 176 liaison to the International Accreditation Forum
(IAF), co-chair of the IAFs ISO 9000 advisory group, and member of the Auditing Practices Group and the Accreditation Council of the ANSI/ASQ National Accreditation Board. Palmes is an ASQ-certified quality manager,
British Standards Institution-certified ISO 9001 auditor and has a masters degree in administration from Gonzaga University in Spokane, WA.
DENISE ROBITAILLE is the author of 12 books, including ISO 9001:2008 for Small and Medium-Sized Businesses (ASQ Quality Press, 2010), and an internationally recognized speaker and trainer. She is an active member
of TAG 176, where she has participated in the revision of multiple standards. Robitaille is an ASQ fellow, an
Exemplar Global-certified lead assessor and an ASQ-certified quality auditor.
JOHN E. JACK WEST is a member of Silver Fox Advisors in Houston. He is past chair of TAG 176 and lead
delegate of the committee responsible for the ISO 9000 family of quality management system standards. He is
an ASQ fellow and has co-authored several ASQ Quality Press books.
ISO 9001:2015
Prepare for a New Structure

by Deann Desai and Susan L.K. Briggs
What is the change?
a unifying and agreed-on high-level structure, identical
The structure of ISO 9001 has been revised. Clauses and
core text, and common terms and core definitions.
subclauses are retitled and reordered according to a
There are 10 elements in the Annex SL high-level
high-level structure that allows for all management sys-
structure:
tem standards (MSS) to be aligned.
1. Scope.
To fully understand this change, some background
2. Normative references.
explaining why it was done should be helpful. From the
3. Terms and definitions.
early 1990s, the International Organization for Standard-
4. Context of the organization.
ization (ISO) technical committee for quality manage-
5. Leadership.
ment (ISO/TC 176) and its technical committee for en-
6. Planning.
vironmental management (ISO/TC 207) worked together
7. Support.
to enhance compatibility and avoid conflicting require-
8. Operation.
ments between ISO 9001 and ISO 14001, the internation-
9. Performance evaluation.
al environmental MSS.
10. Improvement.
In 2003, the ISO General Assembly received advice
These elements have driven the changes that users
from advisory and user groups that greater alignment of
will find in ISO 9001, including the restructuring of the
the structureincluding clause sequence and require-
standard from eight clauses in the 2008 version to 10
ments in the standardswas desirable and achievable,
clauses in the 2015 version.3
and that this would benefit organizations implementing

more than one MSS.
What do I need to do?
In 2005, the ISO Technical Management Board estab-
A frequently asked question about this change is: Must
lished a technical advisory group to fulfill this task, and a
organizations renumber their documents and other rel-
joint vision and high-level structure for all MSSs was de-
evant items based on the new structure of the standard?
veloped. Building on this, the group developed the MSS
The short answer is: No, you do not need to renumber,
requirements, which were published as Annex SL in the
but many organizations will choose to do so as a tracking
ISO/IEC Directives1, 2 in 2011.
mechanisma way to keep things straight and ensure
Annex SL defines the high-level structure including
they are able to do a full review and cover the require-
common text, terms and definitions along with guidance on
ments. Keep in mind that there is no guarantee the num-
how they should be applied. The impact of Annex SL is that
bering will remain the same in future revisions.
all ISO management system requirements standards will be
Some of the main changes in ISO 9001:2015, includ-
aligned, and ISO will seek to enhance the compatibility of
ing introduction of context of the organization and risk,
these standards through the promotion of identical:
came from the use of the high-level structure.
Clause titles.
One of the key responses in the user survey conduct-
Sequence of clause titles.
ed prior to writing the revision was that the connection
Text.
with the larger, strategic view of the organization was
Terms and definitions.
missing. The introduction of a clause related to a con-
These items are permitted to diverge among standards only where necessitated by specific differences in
managing the individual fields of application.
cept called the context of the organization addressed

this concern.
The intent of this clause is for organizations to have a
high-level (strategic) understanding of the important is-
What does it mean?
sues that can affect a management systempositively or
The aim of Annex SL is to enhance the consistency and
negatively. Part of an organizations context also includes
alignment of existing and future ISO MSSs by providing
relevant needs and expectations of interested parties that
apply to its QMS. Knowledge of the issues and inter-
prevents or reduces undesired effects, and achieves
ested party requirements is used to guide the efforts to
continual improvement. Annex SL calls for actions to
plan, implement and operate a QMS.
address risks and opportunities in subclause 6.14 but
The issues identified by an organization and the relevant requirements of interested parties are linked to
does not require risk management, risk assessment or

risk treatment.
the section on planning. The organization plans how
The addition of these two strategic business pro-
it will address any negative or positive consequence
cesses were included to encourage an organizations
posed by these issues and requirements in a prioritized
top management to become more actively engaged,
fashion in its QMS.
ensuring the QMS takes a more strategic view and is
The purpose of planning is for an organization to
integrated into its business processes, with the overall
anticipate potential scenarios and consequences, and
intent to promote improved performance of the QMS.
as such, is preventive in addressing undesired effects

before they occur. Similarly, organizations should look
for favorable conditions or circumstances that can offer a potential advantage or beneficial outcome, and
include planning for those worthy of pursuit.
An organization has the authority and autonomy to
decide which risks and opportunities it must address
to ensure its QMS achieves its intended outcome,
REFERENCES AND NOTE

1. International Organization for Standardization and International Electrotechnical Commission, ISO/IEC Directives, Part 1, Consolidated ISO Supplement, Procedures specific to ISO, sixth edition, 2015, Annex SL, Appendixes
2 and 3.
2. For additional guidance on the intent of Annex SL, review Appendix 3 of
Annex SL in the ISO/IEC Directives, see reference 1.
3. Sandford Liebesman, Work in Progress, Quality Progress, November 2013,
pp. 52-53.
4. International Organization for Standardization and International Electrotechnical Commission, ISO/IEC Directives, see reference 1, subclause 6.1.
Understand Your Context

by John E. Jack West and Charles A. Cianfrani
What is the change?
direction, and to monitor and review information re-
The latest edition of ISO 9001 contains content that will
lated to these external and internal issues.
appear new to some users. The newness of the content
These requirements inject a QMS into an organiza-
will vary widely among organizations depending on
tions strategic planning process. At a minimum, to de-
their existing QMSs. An organizations prior compli-
termine external and internal issues that are relevant to
ance could have ranged from the absolute minimum
its purpose and its strategic direction,2 an organization
to deployment of processes that address the explicit
must know its strategic direction.
requirements and the intent of the latest requirements.
This clause introduces the concept of requiring an
ISO 9001:2015s clause 4, dealing with context of the
organization to think at strategic and tactical levels
organization, therefore may require a widely different
when it develops and deploys its QMS. Neither big-pic-
range of attention by organizations transitioning to the
ture strategic thinking nor detailed analysis and tacti-
new version.
cal thinking is sufficient by itself.
Clause 4 introduces some new language and ex-
The standard mandates consideration of internal
pands concepts related to defining requirements. A few
and external issues that affect the ability of the organi-
of the more notable changes include:
zation to achieve its intended results. The requirements
Understanding the organization and its context.
also say the organization shall monitor and review the
External and internal issues.
issues it considers to be relevant to its purpose.
Understanding the needs and expectations of relevant interested parties.
What does it mean?
Subclause 4.1 contains requirements for an organi-
The requirements for understanding an organization
zation to determine external and internal issues that
and its context mean an organization must know itself
can affect and are relevant to its purpose and strategic
and the external organizations and factors that do or
ISO 9001:2015
can affect it. Achieving such an understanding can result
considered for serious attention. Self-assessments can
from activities such as performance of competitive anal-
be complex, using criteria such as those of the Malcolm
ysis, assessment of existing and emerging technology,
Baldrige National Quality Award, the European Founda-
and evaluation of its impact on the environment.
tion for Quality Management or the ASQ guidelines for
Such activities and assessments are elements of over-
performing a QMS self-assessment.
all strategic and tactical planning for an organization and
Assessment also can be simplified by using the seven
its associated QMS. It also forms a context for develop-
quality management principles as a guide.4 It is up to
ing, implementing, maintaining and improving a QMS.
each organization to determine how detailed the analy-
This subject is a normal topic for top managers and is

interrelated with subclause 5.1.1 on leadership and commitment,3 which requires top management to ensure a
sis should be and what follow-up action, monitoring and

review is needed.
External issues can be found through several tech-
quality policy and quality objectives are compatible with
niques such as analysis of:
an organizations strategic direction and context. This is
Economic environment and trends.
a key top management role in the development of a QMS.
International trade conditions.

Competitive products and services.
Opportunities and conditions related to outsourcing.
What is meant by determine external and internal is-
Technology trends.
sues? What should be considered? How far should you
Raw material availability and prices.
go?
Potential changes in statutes and regulations.
One suggested approach is to have a formal process

for deciding what to consider and why. This approach
makes sense for several reasons:
Benchmarking best-in-class performers in and outside the current marketplace.

Also consider the potential interactions with other
1. It formalizes the process to ensure it is invoked.
processes of your QMS. For example, subclause 4.1 may
2. It precludes going overboard on determining pertinent
have direct or indirect interactions with your processes
external and internal issues.

3. If certification is an organizational objective, it pre-
dealing with interested parties, risks and opportunities,

or with clauses 8, 9 and 10.
empts disputes with external auditors regarding
These new requirements related to the organization
compliance. The notes to subclause 4.1 provide guid-
and its context should provide the organization an op-
ance.
portunity to expand the breadth and depth of its QMS,
An organization, for example, could develop a list of
integrate the QMS with the strategic and tactical manage-
areas in which issues could exist and perform periodic
ment of the organization, and align objectives throughout
evaluations of any existing or emerging problems that
the organization.
might affect meeting requirements.

Examples of internal issues that could be considered
include:
Internal audit results and self-assessment results.
Analysis of quality cost data.
Analysis of technology trend information.
Competitive analysis.
Results of customer reviews, audits, complaints and
feedback.
Actual versus intended internal values and culture.
Organizational performance.
Best practices of the organization and comparisons
with industry benchmarks.
Employee satisfaction data analysis.
One process that is underused but powerful in identifying internal issues is a self-assessment. It should be
REFERENCES
1. International Organization for Standardization, ISO/FDIS 9001:2015Quality
management systemsRequirements, clause 4.
management systemsRequirements, subclause 4.1.
management systemsRequirements, subclause 5.1.1.
management.
SMALL BUSINESS
CHALLENGE
Are you a small business trying to navigate the transition to ISO

9001:2015? Read about the unique obstacles small business face in
implementing ISO 9001 and the resources available to help in Denise
Robitailles online sidebar Resources: The Small Business Challenge,
on this articles webpage at www.qualityprogress.com.
Consider Risk
by Denise Robitaille
What is the change?
Many of the changes in ISO 9001:2015 will involve a
ISO 9001:2015 disperses language relating to risk
paradigm shift across all functions. The most prevalent
throughout the standard. The logical segue is that be-
of these relates to the concept of risk-based thinking.
cause the QMS touches most processes and departments, the need to engage in risk-based thinking is
What does it mean?
similarly expanded to encompass multiple functions
The idea of risk-based thinking isnt particularly dif-
throughout the organization.
ficult. Whenever an organization decides to change
What happens if you change the design of your most
something or to respond to an impending change, there
popular product? You improve your position in the
are choices, consequences, opportunities and risks.
marketplace and beat the competition. You also incur
ISO 31000 GUIDES RISK-BASED THINKING

ISO 9001 includes two new and related requirements: under-
popular internationally, and it will be helpful in implementing ISO
standing the organization and its context, and risk-based think-
9001:2015. As a guidance document, it allows for tailoring to
ing. The latter is a term that is nonexistent in current quality and
various systems including the management of quality. It is help-
risk nomenclature. How should you understand, implement and
ful for understanding the organization and its context, which
audit to this requirement?
is sparsely defined in ISO 9001:2015, but more fully detailed in
Fortunately, you dont have to reinvent the wheel. These

concepts and their implementation are detailed in ISO 31000,1
the international risk management standard. Although ISO
sections 4 and 5 of ISO 31000. These sections explain the how

and why of establishing the context.
Like ISO 9001, ISO 31000 is more clearly understood after
31000 uses different terms, referring to that standard can help
professional training. Quality professionals who master ISO
organizations implement risk-based thinking in the context of
31000 will be able to identify how detailed an organizations
ISO 9001.
risk-based thinking implementation must be to satisfy the re-
The writers of ISO 9001:2015 state that risk-based thinking

has always been implicit in ISO 90012 and chose not to require
quirements of ISO 9001:2015.

Why should your organization embrace risk management as
a full, formal and systemic risk management method, such as
part of your quality system? The answer is stated in ISO 31000:
ISO 31000. The risk-based thinking requirement allows organiza-
All organizations manage risk to some degree.3 In laymans
tions the flexibility to choose either a basic approach or a more
terms, managing risk is simple: Make decisions while consider-
extensive formal risk management process based on what is
ing how the potential consequences of unknown factors can
appropriate for an organization.
help or hinder your organizations objectives.
Explicit in the new standard, however, is the requirement that
This idea is not new. The management of uncertainty is
some minimal risk management be integrated into an organiza-
something you do each day in your personal and professional
tions quality system. Indeed, the writers deliberately created
lives to ensure you achieve your objectives. The requirement
the term risk-based thinking to encompass the varying, ac-
that consideration of uncertainty be part of formal and auditable
ceptable degrees in which organizations may choose to manage
processes will serve to further quality and corporate objectives.
risk. Employing the term risk management may have implied

full adherence to the ISO 31000 standard is required, a suggestion defeated in early international revision negotiations.
While using ISO 31000 is not required in ISO 9001:2015,
the existing risk management standard already has become
Allen Gluck
REFERENCES
1. International Organization for Standardization, ISO 31000:2009Risk management
Principles and guidelines.
2. International Organization for Standardization, ISO/FDIS 9001:2015Quality management
systemsRequirements.
3. Ibid.
ISO 9001:2015
the need to carry inventory of replacement parts be-
ses and implementing sophisticated risk management
cause youve made a commitment to your customers
programsall slick with data, pretty charts and graphs
to continue to support older versions of the product.
printed on high-gloss paper. This is hardly a capabil-
How about signing a contract that will double your

business? Youll make a ton of money if you can: Get
ity for a small delivery service organization or a fiveperson machine shop.
suppliers to ship extra raw material, hire 15 more
To help an organization of any size get over this
techs, put on a second shift and maintain the produc-
hurdle, look no further than clause 4 of ISO 9001:2015.1
tion schedule to keep your other customers happy.
All of the language about the context of the organization is directly relevant to the conversation about risk.
To understand your risks, you must understand your
All organizations, but especially small companies,
organizationits internal and external issues, the in-
must apply risk-based thinking in their internal envi-
terested parties that can have an effect on it and its
ronments. A small amount of effort along these lines
ability to fulfill customer expectations.
can lead to big results. ISO 9001:2015 allows organiza-
These concepts also can be parsed into smaller
tions the flexibility to apply as little effort as is needed.
components. For smaller organizations, issues can be
When implementing risk-based thinking, parse
as simple as the retirement of one person, the loss of a
things out into manageable chunks. The benefit is that
supplier, a change in cash flow, a major road repair out-
youll have fewer unpleasant surprises resulting from a
side their entrance or change in the local schools cal-
failure to adequately assess the risk associated with a
endar affecting parents who need daycare. All of these
change. The change can be as small as substituting an
events carry risks that must be managed properly.
epoxy or as overwhelming as moving the business to a

new facility.
There are other changes that must be understood

and implemented. All the changes carry some benefit.
One of the side benefits of the inclusion of risk-
The transition process itself carries its own benefit
based thinking in ISO 9001:2015 is that it eliminates the
because implicit in the transition is the opportunity to
ineffectual and cumbersome preventive action process
objectively assess a system and sweep away what isnt
included in ISO 9001:2008.
working.
Often, risk is presumed to be within the purview

of large companies with loads of quality technicians
and MBAs performing failure mode and effects analy-
REFERENCE
management systemsRequirements, clause 4.
Leaders, Step Up
by Paul C. Palmes
What is the change?
ed issueswith primary top management interaction
The 2015 revision of ISO 9001 contains several impor-
through management review.
tant improvements regarding top management. Specifi-
Thats about to change. According to subclause 5.1.1,
cally, subclause 5.1.1 on leadership and commitment
top management is required to demonstrate leadership
for the QMS1 includes 11 requirements designed to en-
and commitment with respect to the QMS by:
sure top management is involved and committed more
1. Taking accountability of the effectiveness of a QMS.
than ever before to the QMS.
2. Ensuring the quality policy and quality objectives
Observers of ISO 9001 throughout the years have
are established for a QMS and that they are compat-
consistently and correctly commented that QMS imple-
ible with the strategic direction and the context of
mentation results suffer without real top management

support. As a result, organizations are left to install
bolt-on quality systems limited to production relat-
an organization.
3. Ensuring the quality policy is communicated, understood and applied in an organization.
4. Ensuring the integration of the QMS requirements

into an organizations business processes.
If you can clearly imagine the best outcome of each

meeting, you can work backward to imagine everything
5. Promoting awareness of the process approach.
you may need to achieve a successful set of results.
6. Ensuring the resources needed for a QMS are avail-
After all, for many organizations, effective implemen-
able.
7. Communicating the importance of effective quality
management and of conforming to QMS requirements.
tation of subclause 5.1.1 will require a fundamental

paradigm shift in which top management participates
rather than observes.
There is, for example, a new requirement to promote
8. Ensuring a QMS achieves its intended results.
awareness of the process approach. No doubt, this may
9. Engaging, directing and supporting persons to con-
become a teachable moment for many organizations,
tribute to the effectiveness of a QMS.

10. Promoting continual improvement.
requiring prepared materials to explain this fundamental concept to top management during these meetings.
11.
Supporting other relevant management roles to
Take your time. Be prepared and professional in
demonstrate leadership as it applies to leaders re-
your approach. Develop appropriate action items and
spective areas of responsibility.
venues for each requirement. Perhaps your organization routinely schedules an all-organization business
What does it mean?
status meeting conducted by top management. This
From the perspective of an organization that is already
may be the perfect place to communicate the impor-
implementing ISO 9001 and looking to transition to the
tance of effective quality management and of conform-
new version of the standard, some will proudly affirm
ing to QMS requirements.3
the existing link between quality and business goals,
Others requirements in subclause 5.1.1 are also fair
while others face a major realignment of their existing
game for such events, and if you use PowerPoint to
systems.
present, you now have a record of compliance. (The
Yes, some of the above requirements, such as en-
correct term is now documented information, but its
suring that the quality policy is communicated, un-
still acceptable to use terms to which youve become
derstood and applied within the organization, are
accustomed).
management responsibility-related holdovers from
Naturally, to just proclaim support is not enough,
the 2008 revision. Several additional requirements in
and similarly no one expects top managers to move
the 2015 revision, however, affirm a fundamental shift
into the quality department. The real work will be
from having top management simply provide direction
somewhere in between when it becomes obvious to
and support to its becoming a key participant.
everyone that top management actually is using the
The QMS now must consider how to manage ensur-
quality system to guide and validate its decisions and
ing the integration of the QMS requirements into the
to encourage the discovery of new areas of improve-
organizations business processes. They are now one
ment throughout the organization.
and the same, requiring quality objectives to support

the achievement of the organizations business goals.
Fundamentally, clause 5.1.1 in ISO 9001:2015 is a

call for top management involvement in the QMS. In-
Who better to ensure business success than top
tegration of the QMS requirements into the organiza-
management? After all, top management also is tasked
tions business processes requires analysis and collab-
in the new version of ISO 9001 with engaging, direct-
oration on both sides. As the two become one, working
ing and supporting persons to contribute to the effec-
together to support common goals, the organization
tiveness of the QMS.
develops deeper purpose, strength and success.
wish to achieve when you begin with the end in mind.
Thats the vision you must encouragethe goal you

Given the importance of the material, explaining all
these changes to top management will best be accomplished through several meetings. It may be constructive to use the second of Stephen R. Coveys seven
habits by beginning with the end in mind.2
REFERENCES
2. Stephen R. Covey, The Seven Habits of Highly Effective People, Free Press,
1989.
3. International Organization for Standardization, ISO/FDIS 9001:2015Quality management systemsRequirements, see reference 1.
ISO 9001:2015
Determine Your
Documentation Needs
by Bill Aston
What is the change?
lowing 18 records to be retained:
One of the more notable changes in ISO 9001:2015 will
1. Monitoring and measurement of resources (sub-
be the nonexistance of any reference to requirements
clauses 7.1.5.1 and 7.1.5.2, a).
for a quality manual, documented procedures and re-
2. Personnel competency (subclause 7.2, d).
cords to be maintained. Does this mean documented
3. Operational planning and control (subclause 8.1, e).
procedures, records and other QMS documents are not
4. Review of requirements related to products and services (subclause 8.2.3.2).
necessary?
No, that is not the case. Consider the requirements
5. Design and development inputs (subclause 8.3.3).
of ISO/FDIS 9001:2015, subclause 4.4.2.1 This sub-
6. Design and development controls (subclause 8.3.4, f).
clause requires an organization to maintain document-
7. Design and development output (subclause 8.3.5).
ed information (procedures) to support the operation
8. Design and development change (subclause 8.3.6).
of its processes and to retain documented information
9. Externally provided product and services (sub-
(records) to have confidence that processes were per-
clause 8.4.1).
10. Traceability (subclause 8.5.2).
formed as planned.
Annex A, section A.6, provides guidance regarding
the references made to requirements throughout the
11. Property belonging to customers or external parties

(subclause 8.5.3).
standard to maintain documented information (such
12. Control of change (subclause 8.5.6).
as procedures, quality plans and a quality manual) as
13. Release of product and services (subclause 8.6).
well as to retain documented information (records).
14. Control of nonconforming process output, products
How are an organizations requirements for QMS

documents determined? Every organization will be
responsible for determining the level of documented
and services (subclause 8.7.2).

15. Monitoring, measurement, analysis and evaluation
(subclause 9.1.1).
information, such as procedures, needed to support its
16. Internal audit (subclause 9.2.2).
QMS, processes, product and services.
17. Management review (subclause 9.3.3).
ISO 9001:2015 will specifically require risk-based

thinking to be a part of every organizations process
18.
Nonconformity and corrective action (subclause
10.2.2).
approach to quality. Risk-based thinking is not a new

activityits a regular part of an organizations QMS
What does it mean?
and product planning processes, which includes ensur-
Concerning requirements for documented information
ing controls, such as procedures or instructions, are
to be maintained (procedures), ISO 9001:2015 will be
established to address identified risks.
less prescriptive. This increased flexibility will sup-
ISO/FDIS 9001:2015 requires the following docu-
port requirements for documented information to be
mented information to be maintained by every organi-
scaled to be appropriate to the complexity and criti-
zation:
cality of the products produced or services provided.
Scope of the QMS (subclause 4.3).
The greater the risk or potential consequences of the
Information needed to support the operation of its
nonconformance, the more control (procedures) re-
processes (subclause 4.4.2, a).

Quality policy (subclause 5.2.2, a).
Quality objectives (subclause 6.2.1).
Control of product and services (subclause 8.5.1).
Furthermore, ISO/FDIS 9001:2015 identifies the fol-
quired to address the probability of the risk and its

potential impact.
Documented information may include procedures, work instructions, drawings, checklists, data
sheets, media or records as deemed appropriate for
ISO 9001:2015
an organizations operation.
ISO 9001:2015 will provide an organization in-
Risk-based thinking is essential for identifying risk
creased flexibility to maintain a QMS specific to its
and the resources, such as personnel competencies,
particular processes and product. Risk-based thinking
equipment, facilities, product and services design, ma-
will drive the organizations need to ensure document-
terials, process procedures and instructions required
ed information, such as procedures, instructions and
to address those risks. ISO 9001:2015 will not require
other QMS documents, are available to address risks
formal risk assessments. The organization will deter-
and opportunities. ISO 9001:2008 certifications will not
mine whether a formal risk assessment is required and
be valid after three years from the publication date of
if so, select a risk assessment method that best suits
ISO 9001:2015.
its needs.
The International Accreditation Forum Informa-
Future QMS audits will require auditors, consul-
tive Document 9: 2015 Transition Planning Guid-
tants and other interested parties to use a different ap-
ance for ISO 9001:20155 provides general guidance to
proach to determining an organizations conformance
organizations, certification bodies and accreditation
with ISO 9001:2015 requirements. Auditors must be
bodies for preparing to transition from ISO 9001:2008
knowledgeable about the risks associated with the
to ISO 9001:2015.
products, services and processes being audited, and be
Future QMS auditing will need a different approach
able to assess the effectiveness of the controls used to
to determining an organizations conformance with
manage those risks.
ISO 9001:2015 requirements. Techniques and skills

for auditors, consultants and other quality profession-
als must change to meet the new challenges of ISO
Consider the following actions to prepare for transi-
9001:2015. QP
tioning to ISO 9001:2015:

1. Obtain a copy of ISO FDIS 9001:2015 and become
familiar with its requirements.
2. Attend ISO 9001:2015 training via your registrar, the
Professional Evaluation and Certification Board,
Exemplar Global College, ASQ or other accredited
training providers.
3. Consider training on ISO 31000:2009Risk man-
REFERENCES
management systemsRequirements, Annex A, section A.6.
3. International Organization for Standardization, ISO 31000:2009Risk managementPrinciples and guidelines.
4. International Organization for Standardization, Technical Committee 176,
Subcommittee 2 (ISO TC/176/SC2) homepage, http://tinyurl.com/TCSC2.
5. International Accreditation Forum (IAF), IAF Informative Document 9: 2015
Transition Planning Guidance for ISO 9001:2015, Issue 1, Jan. 12, 2015.
agementPrinciples and guidelines to ensure familiarization with basic risk-management practices

and terms.3
4. Download free copies of risk-based thinking documents and PowerPoint slides via the ISO website.4
This information may be helpful for promoting and
understanding risk-based thinking.
5. Conduct a gap analysis of your existing QMS. Ask
your registrar to provide a checklist suitable for this
purpose.
6. Contact your registrar to determine its timeline
and requirements to transition clients with existing QMS certifications from ISO 9001:2008 to ISO
9001:2015.
7. If your organization is currently planning or in the
process of obtaining an ISO 9001 certification, contact your registrar to determine their timing to begin
issuing ISO 9001:2015 as opposed to ISO 9001:2008
certifications.
REVISION
RESOURCES
ISO 9001:2015 is scheduled to be released later

this month and will be available for purchase at
asq.org. Find out more about the new standard by:
Tuning in to the ASQ Standards Channel (videos.
asq.org/asq-standards-channel) to watch
experts discuss changes and transition advice.
Subscribing to the Standards Connection
enewsletter at asq.org/standardsconnection to
have information delivered to your inbox every
month.
Visiting Standards Central at asq.org/standards,
where you can find updates, articles and more.
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TRAINING
CERTIFICATION
CONFERENCES
MEMBERSHIP
PUBLICATIONS
at Software
Quality
In 50 Words
Or Less
Software products are

more scrutinized today
than ever because problems can be costly.
One pilot program used
the ISO/IEC 25000 family of standards as a
framework to evaluate
software product quality.
The structure let developers address maintenance issues, as well
as product quality and
issues related to development processes.
Pilot program uses ISO/IEC

25000 family to evaluate,
improve and certify
software products
by Moiss Rodrguez, Mario Piattini
and Carlos Manuel Fernndez
SOFTWARE QUALITY
SOFTWARE QUALITY IS a key challenge for organizations because of its impact on final costs. At the same time, software
quality can be a competitive differentiator an organization can offer
to its customers.
The importance of software quality is accentuated when you consider the
losses organizations can incur when quality problems arise in software development projects. In fact, only 39% of software projects finish on time with the
planned resources and with acceptable quality, according to the Standish Groups
latest report The CHAOS Manifesto.1 See Figure 1 (p. 32).
To highlight the importance of software quality, a laboratory in Spain performed a pilot program to evaluate, improve and certify the quality of software
products.
Software evaluation
with Alarcos Quality Center (AQC), a spin-off of the Uni-
Activities related to software quality have become in-
versity of Castilla-La Mancha, conducted the evaluation
creasingly important, especially as more organizations
and certification pilot project using the new ISO/IEC
outsource their software functions. This means client
25000 family of standards.
organizations must assess and monitor the quality of the
AQC and AENOR are independent organizations. AQC
products they receive from software development orga-
is responsible for evaluating software product quality,
nizations. In turn, these software development organiza-
thus permitting organizations to meet a quality level and
tions must have the necessary resources to ensure the
improve their software products. AENOR, as an auditing
products developed will meet client expectations.
entity, is responsible for certifying the software product
Despite the proliferation of software quality process

certifications (for example, ISO/IEC 15504 Informa-
in cases in which organizations, in addition to improving

their products, wish to become certified.
Initially, this pilot project mostly focused on the qual-
tion technologyProcess assessment and certifications

from the Capability Maturity Model Integration Insti-
ity characteristic of maintainability because:
tute), there is little evidence conformance to process
Maintenance is one of the most expensive phases in
standards actually guarantees good products. In fact,
the software life cycle and, in some cases, can reach

up to 60% of costs.
critics suggest process standards guarantee only the uniformity of output and can possibly institutionalize the
Maintainability is one of the features most frequently

requested by software customers. It must be possible
production of mediocre or bad products.2
for customers to evolve software products they ac-
The idea that software evaluations should be based
quireeither by themselves or via a third party.
on direct evidence about a products attributes rather

than circumstantial evidence about processes used to
Maintenance work on products with little maintain-
build a product3 is becoming more widespread. An ever-
ability is more likely to introduce new bugs into soft-
increasing number of organizations therefore are con-
ware products.
cerned not only about the quality of the processes, but
The evaluation and certification based on this family
also the quality of the products they develop and acquire.
of standards provides software development organiza-
This is because they may have serious quality problems
tions and organizations that acquire such software a set
after the product has been implanted into their servers.
of benefits, which are shown in Figure 3 (p. 34).
The new ISO/IEC 25000 family of standards, also

known as SQuaRE (Software Product Quality Require-
Five activities
ments and Evaluation), appears to meet these needs.
For this project, it was first necessary to create the AQC
ISO/IEC 25000 aims to create a common framework to
Lab using an agile approach,6 responsible for carrying
evaluate software product quality, replacing ISO/IEC
out the software product quality evaluation process. This
9126 and ISO/IEC 14598 and becoming the cornerstone
laboratory performs evaluations by conducting the five
of this area of software engineering.
activities proposed in ISO/IEC 25040:
ISO/IEC 25000 is composed of several parts: ISO/IEC
1. Establish evaluation requirements: This activitys
250404 defines the process of evaluating software prod-
aim is to establish an agreement between the labora-
uct quality, and ISO/IEC 250105 determines the software
tory and client about which purpose and quality re-
product characteristics and subcharacteristics that can
quirements will be considered for the product evalu-
be evaluated (see Figure 2).
ated. To this end, parts of the software product that
The Spanish Associa-
will be evaluated are identified, and the rigor of the
Project resolution
results / FIGURE 1
39%
43%
18%
and
Certification
(Aso-
The results are an initial version of the evaluation
ciacin Espaola de Nor-
plan along with a list of requirements. The pilot proj-
Successful
malizacin y Certificacin,
ects scope was the complete software products.
Failed
or AENOR), which is a
Although some organizations had defined quality re-
Challenged
member of the Internation-
quirements for their software products (such as low
al Certification Network
complexity or good documentation), a decision was
(IQNet), in collaboration
made to expand them to the requirements associated
Results from 2012 CHAOS research
evaluation that will be performed is clearly defined.
tion for Standardization
SOFTWARE QUALITY
Software product quality model from ISO/IEC 25010
/ FIGURE 2
Product quality model

Functional
suitability
Performance
efficiency
Compatibility
Usability
Reliability
Appropriateness
recognizability
Functional
completeness
Functional
correctness
Functional
appropriateness
Time behavior
Resource use
Capacity
Learnability
Maturity
Coexistence
Operability
Availability
Interoperability
User-error
protection
Fault tolerance
User-interface
aesthetics
Recoverability
Security
Maintainability
Portability
Confidentiality
Modularity
Integrity
Reusability
Nonrepudiation
Analyzability
Installability
Accountability
Modifiability
Replaceability
Authenticity
Testability
Adaptability
Accessibility
ably, and the evaluation results are stored in a secure
with the laboratory model.
repository, which can be accessed via a web applica-
2. Specify the evaluation: This activitys objective is
tion that allows visualization and analysis.
to select the quality metrics that will be measured in

the software product (that is, to create the evaluation
module). The decision criteria that establish thresholds for metrics and indicators used to assign values
to the subcharacteristics and quality characteristics
of the product also are defined.

The result of this activity is a set of values obtained

for all metrics, indicators, subcharacteristics and
quality characteristics.
5. Conclude the evaluation: This activitys purpose is

to analyze the results obtained in the previous activ-
The result of this activity is a refined version of the
ity to ensure no errors occurred during the evaluation
evaluation plan with metrics and defined criteria.
and to generate the final evaluation report. This re-
In the pilot project, all the properties of the quality
port is the main output of the evaluation process and
laboratory model (covered later) were selected as the
will be delivered to the customers to allow them to
thresholds established by the laboratory to certify the
review it and, if necessary, express disagreement.
product.
Figure 4 (p. 34) shows sections of this evaluation re-
3. Design the evaluation: This activitys purpose is to
port for one of the pilot project products. During this ac-
plan the measurement and evaluation activities that
tivity, the laboratory also performs the disposition of the
must be conducted, taking into account the prespeci-
evaluation datathat is, all records that no longer need
fied scope and availability of laboratory resources.
to be maintained (for example, product source codes)
The result of this activity is the final version of the
are removed. This also occurs for confidentiality reasons
evaluation plan, with details of the dates of evaluation
because any data that the client does not wish to remain
activities and the specific resources involved.
in the laboratory after the completed evaluation are re-
In the pilot project, an initial assessment was
turned or eliminated.
planned for each product. This assessment lasted
It is also necessary to consider that the family of ISO/
two weeks. Each organization requested a month to
IEC 25000 standards defines models and processes to as-
correct its software products. Finally, the laboratory
sess the quality of software products, but it does not es-
planned a second evaluation of each product, which
tablish a correlation between the metrics and thresholds
took one week.
needed to identify the specific level of quality a software
4. Execute the evaluation: This activitys purpose is
product has.
to perform measurements on the software product
The laboratory, therefore, has defined not only a mod-
and apply the decision criteria specified in the second
el and a quality process that are aligned with ISO/IEC
activity. Thanks to the automated laboratory environ-
25000, but it also has identified a set of measurable qual-
ment, this activity can be performed quickly and reli-
ity properties from the software products source code.
Quality properties
structure of a system at any level (for example, sub-
The objective of identifying these quality properties was
systems, packages and classes) facilitates develop-
not to form the largest set of these quality properties pos-
ment and maintenance.
sible, but rather to assemble a whole group that was not
Method sizeThe size of a system directly affects
controversial, based on previous studies and research,
its maintainability because a larger system obviously
and accepted by the scientific community. The main
requires more maintenance. It is considered more ap-
properties are:
propriate to evaluate the size of the elements at a low-
Violation of encoding rulesThis property is
er level by using, for example, methods that directly
based on encoding rules for each language (such as
evaluate the overall size of the system. This is because
Java code standard) and the percentage of violations.
a change does not usually affect the entire system, but
A set of related rules are checked for each quality subcharacteristic.
rather a set of elements.

Duplicate codeThis property refers to code frag-
Code documentationThis property refers to com-
ments repeated in different parts of the system. Du-
ments in the code that are used to explain the codes
plicate code makes it difficult to modify a software
functionality. Well-documented code helps develop-
application because solving a bug or making an im-
ers understand what it does. Comments also may in-
provement to the code requires changes to all parts of
fluence the ability to reuse software because if you
the system where the duplicate code appears.
know the functionality of a module, you can reuse

that module in another system.
CouplingThis property indicates the degree of interdependence among software units (modules, func-
Cyclomatic complexityThis property is related to
tions, classes and libraries, for example). Generally,
the difficulty involved in implementing, testing, under-
the lower the coupling in a software application, the
standing, maintaining or modifying a program. As this
better its design is considered because low coupling
definition shows, the complexity is related to the fol-
improves maintainability (if there is no coupling,
lowing subcharacteristics: analyzability, modifiability
changes to one unit do not affect other units) and in-
and testability. In applications with high complexity,
creases the reusability of software units.
maintenance tasks require more effort and, therefore,

are more costly.
CyclesThis property refers to the existence of cycles of dependence among the system packages. The
StructuringThis property refers to dividing the
acyclic dependencies principle states there must be no
system into smaller parts. The quality of the system
cycles in the dependency structure of a system. The ex-
design is closely related to this property: The correct
istence of cycles in a system has a negative effect on its

maintainability because a change that is made to one
Benefits of evaluating software

product quality / FIGURE 3
packet affects all the packets in the cycle.7

CohesionThis property indicates the degree of relationship between the elements in a module. A class
has low cohesion when it performs several unrelated
Software
development
companies
Control software product quality.
functions. The functionality provided by its methods
Improve product characteristics.
thus has little in common with them. The analyzabil-
Ensure customers receive the appropriate

level of quality.
ity, modularity and, in general, maintainability are
Compare among competitors products.

Place the product on the market.
Increase product sales.
negatively affected because these systems are more

difficult to understand. They provide features that are
unnecessary and changes in requirements that affect
several modules.
Know the quality of the product purchased.
Organizations
that acquire
software
The evaluation process, the quality model and the
Compare between alternatives.
properties, along with a measurement environment,
Establish service-level agreements.
allow a laboratory to evaluate a software product and
Attain vendor independence.
calculate its quality values. The measurement environ-
Minimize production failures.
ment automates the evaluations by up to 90% and has
Reduce the final cost of acquiring software.
three different levels:
SOFTWARE QUALITY
1. Measuring toolsThese constitute the

first level. Their mission is to analyze the
source code and generate files (usually
Example of evaluation report

results / FIGURE 4
XML) containing information about metrics

and violations of programming rules.
The advantage of this level is that it can
easily be expanded by adding new tools
(an organizations own or via a third party)
that analyze new programming languages or
compute new metrics for other quality characteristics.
2. Evaluation systemThis involves the intermediate level of the environment. Its objective is to analyze all the files generated by
the lower level and apply criteria with which
to evaluate the quality model. The result is
the values for quality properties, subcharacteristics and characteristics.
3. Visualization environmentThis represents the top level of the environment. Its
objective is to present the information ob-
tained after the software product evaluation in an un-
the organization will obtain a quality evaluation report
derstandable manner.
(shown in Figure 4). Based on the reports results, the
Besides showing the values of quality properties,
organization may choose to become certified (if the
subcharacteristics and characteristics, this environ-
level is good) or to refactor the product to meet estab-
ment also allows you to obtain a historical report for

multiple versions of a product, compare different prod-
lished quality thresholds.

Step threeWhen the organization has an evaluated
ucts and even generate predefined reports.
product with an adequate level of quality, it can request
Thanks to this framework, the laboratory has achieved
certification from AENOR by providing its data and the
accreditation as a laboratory for quality software prod-
product to be certified.
uct evaluation as it relates to the ISO/IEC 25000 family
Steps four and fiveAENOR will contact the ac-
of standards from Entidad Nacional de Acreditacin, a
credited laboratory (step four) to check whether the
member of the International Laboratory Accreditation
organization really has evaluated its software product
Cooperation under ISO/IEC 17025.
and the level obtained is adequate for the certification.

In this case, the laboratory will provide AENOR with
Six steps to certify products
the evaluation report (step five) for it to review and
After organizations have evaluated and improved their
continue the certification process.
software products, they can choose to certify these prod-
Step sixFinally, AENOR will carry out the certi-
ucts. To do this, the certification entity (in this case, AE-
fication audit using information from the evaluation
NOR) has developed a six-step process for product certi-
laboratory and information obtained after a visit to the
fication and has defined the communication flow, shown
developer. As a result, AENOR creates an audit report
in Figure 5 (p. 36).
with the results and presents the certificate of product
Step oneIf interested organizations wish to certify
quality when applicable (see Figure 6, p. 36).
the quality of a software product, the first step is to
Several assessments and refactoring cycles were
contact an accredited laboratory and request an evalu-
necessary during the pilot project. Three organizations
ation report. At this point, the five evaluation activities
eventually attained quality certifications for their soft-
will begin.
ware products: a document management system, a digi-
Step twoAs a result of product quality evaluation,
tal library for mobile platforms and supplier application
SOFTWARE QUALITY
REFERENCES
software for healthcare centers.

The chief information officers of the organizations
that achieved certification noted the main benefits for
their certified software:
The amount of code developed was reduced 40%.
The execution and load speed of applications increased.
The corrective maintenance effort was reduced 90%.
Product quality evaluations were incorporated into
the software development life cycle.
1. The CHAOS Manifesto: Think Big, Act Small, Standish Group, 2013.
2. Barbara Kitchenham and Shari Lawrence Pfleeger, Software Quality: The
Elusive Target, IEEE Software, Vol. 20, No. 1, 1996, pp. 12-21.
3. Tom Maibaum and Alan Wassyng, A Product-Focused Approach to Software
Certification, Computer, Vol. 41, No. 2, 2008, pp. 91-93.
4. International Organization of Standardization (ISO), ISO/IEC 25040 Systems and
software engineeringSystems and software quality requirements and evaluation (SQuaRE)Evaluation process, 2011.
5. ISO, ISO/IEC 25010, SQuaRESystem and software quality models, 2011.
6. Javier Verdugo, Moiss Rodrguez and Mario Piattini, Using Agile Methods to
Implement a Laboratory for Software Product Quality Evaluation, presentation
at the 15th International Conference on Agile Software Development, Rome,
May 26-30, 2014.
7. Diomidis Spinellis, Code Quality: The Open Source Perspective, first edition,
Addison-Wesley Professional, 2006.
This pilot project has gained widespread acceptance

MOISS RODRGUEZ is CEO of the Alarcos Quality Center
(AQC) and director of AQC Lab in Ciudad Real, Spain. He
has a masters degree in computer science from the
University of Castilla-La Mancha in Ciudad Real. Rodrguez
is an Information Systems Audit and Control Association
(ISACA)-certified information system auditor, Asociacin
Espaola de Normalizacin y Certificacin (AENOR)-certified ISO/IEC 15504 chief auditor and Test management
approach (Tmap) Next Certified.
by the participating organizationsthose that succeeded in certifying their products and those that did
notbecause they were able to detect the principal
maintenance problems so they wouldnt repeat them in
the future.
This pilot project also has shown that the software development sector can address certification as it relates
not only to the quality of the processes, but also to the
quality of the software product by using a scheme of international standards such as the ISO/IEC 25000 family.
Finally, after this first pilot project, the scope of laboratory evaluations is now being broadened to include
new quality characteristics of ISO/IEC 25000, such as
MARIO PIATTINI is a full professor at the University of

Castilla-La Mancha, where he leads the Alarcos Research
Group. He is also founder and scientific director of ACQ
in Ciudad Real. He has a doctorate in computer science
from the Technical University of Madrid in Spain. Piattini
is a certified information systems auditor (CISA), certified
information security manager (CISM), certified in the
governance of enterprise IT (CGEIT) and certified in risk
and information systems control (CRISC)all from ISACA. He is a senior ASQ
member.
functionality, usability and performance. Furthermore,

AENOR also will support the certification of the new
quality characteristics, and it will work to align the software product certification with the software process
certification. QP
Flow followed during the pilot

software product certification
/ FIGURE 5
1. Request for evaluation of product quality

3. Request for certification
Company interested
in software product
quality
4. Request for evaluation report
AENOR
Asociacin Espaola de
6. Audit results and

certificate of product quality
5. Evaluation results
2. Quality evaluation report

AENOR = Asociacin Espaola de Normalizacin y Certificacin,
or Spanish Association for Standardization and Certification
AQC = Alarcos Quality Center
CARLOS MANUEL FERNNDEZ is manager of information

and communications technology (ITC) and ITC auditor
leader at AENOR. He has been an associate professor at
Pontific University of Salamanca in Madrid since 1987.
Fernndez has a masters degree in computer science
from the Technical University of Madrid. He is a CISA and
CISM from ISACA and has been certified by the Information Technology Infrastructure Library Foundations.
Example of
software product
certificate / FIGURE 6
Whats Online in the

ASQ Knowledge Center?
CASE STUDY
Lack of Reported Medication Errors Spurs
Hospital to Improve Data Focus, Patient Safety
A cross-functional team at Medcare Hospital in
Dubai used a plan-do-check-act (PDCA) approach
to improve medication error reporting.
ASK THE EXPERTS

ISO 9001 and TQM
Ask the Experts panelist Bill Aston discusses the
relationship between the ISO 9001 internal audit
process and total quality management (TQM).
WEBCAST
Triggers: Becoming the Person You Want to Be
Marshall Goldsmith presents research findings on
leadership development, coaching, and engagement,
and introduces a process for changing individual
behaviors and increasing employee engagement.
Access this months featured content and more Web exclusives in the
ASQ Knowledge Center at asq.org/knowledge-center/featured.html.
TRAINING
CERTIFICATION
CONFERENCES
MEMBERSHIP
PUBLICATIONS
TM
Amazing
Audits
Evaluating an audit programs

performance with a standardized
approach and the Kano model
by Lance B. Coleman Sr.
In 50 Words
Or Less
A process and form allows organizations to

evaluate the performance
of their audit programs.
The evaluations score is
applied to the Kano model, determining whether
the program satisfies the
organizations needs.
The process allows organizations to track their
audit programs status
over time and the effectiveness of implemented
improvements.
A QUALITY AUDIT program could

be considered a service for an organization thats provided by the quality department. Because of this, the Kano model can
be the ideal lens for analyzing the performance of an organizations quality audit
program.
In the 1980s, Noriaki Kano created the
model as a theory of how to align product
development with customer needs. Kano
AUDITING
focuses on customer service and the benefits of delivering exceptional value to the
customer, whether internal or external,
through service that delights the customer.
The Kano model recognizes four states:
nonperforming (failure), basic must haves
(cost of entry into the marketplace), performing (more is better) and exciting or
delightful service (surprises and delights
the customer).1
September 2015 QP X39
The model (see Figure 1) stresses the pursuit of delightful service delivery as a driver for continuous im-
having the best plan in the world is worthless if that

plan isnt properly implemented.
provement and business success. It also can be used as
The ability to support corporate and site goals is
a powerful visual for displaying progress in customer
an often-overlooked segment of an internal audit pro-
satisfaction, and it reminds staff of the of the organiza-
gram. It also should be seamlessly integrated into a
tions ultimate goaldelivering outstanding (delight-
risk management program and play an integral role.

The next area of the form addressed reporting and
ful) performance.
When I looked at this model, I asked myself: What
would be attributes of a delightful audit program?
A delightful program would excel in monitoring
compliance, managing risk and driving continuous im-
record keeping. For data to become information, it

must be used, which was why data analysis was added
to this area. Reporting, records and data analysis account for another 30% of the base score.
provement while the program itself continues to im-
The reporting strategy for audit results was ad-
prove. To know whether you have an excellent audit
dressed to ensure critical and major concerns were im-
program, an assessment must take place, but complet-
mediately reported to the appropriate parties. Safety,
ing a quantifiable, accurate and objective assessment
legal and functional issues are examples of findings
of an internal quality audit program is easier said than
that might be reported to a wider group of managers.

The final 30% of the score relates to having adequate
done.
I started by creating an evaluation form (see Figure
resources, organizational structure, variability and
2, p. 43) to produce a ranking that could be incorpo-
breadth of the audit programs impact. Some questions
rated into the Kano model, which provides a needed
that determine whether an audit program has the nec-
framework for evaluating the service of an internal au-
essary resources are:
dit program.
Are there enough auditors to complete the number

of comprehensive audits required within the given
Evaluation forms
timeframe?
The evaluation form assesses critical areas of an audit

program, and it weights audit planning as the largest
Do auditors have the experience, skills and education to evaluate the areas theyre auditing?
component, allotting it 40% of the base score. Planning
Is the required infrastructuresuch as office space,
is a critical element in any endeavor, ensuring all as-
computers and suppliesneeded to manage the
pects of an organization that must be monitored are
program in place?
consistently reviewed, and the evaluation form awards

points for conducting the audits as scheduled. After all,
Is there a budget for travel if off-site audits are required?

Are there authority and management support to con-
Kano model
duct audits?
/ FIGURE 1
After a base score has been attained, you will evaluate how the audit program provides value beyond
Satisfaction
verifying compliance and fulfilling requirements. This
gives the program credit for acting on opportunities for

improvement (see Table 1). If those opportunities had
potential financial savings attached to them, the audit
Delighters
program received additional points.
(excitement factors)
Primary satisfiers
Service
not
functional
Service
fully
functional
Must-be
(basic requirements)
Dissatisfaction
The next step is called the reality check (see Table

2). Each major finding against the audit program found
during external audits, including findings previously
identified by the internal audit program that did not
have successful corrective action implemented, subtracts points from the base score. Finally, there are
point deductions for findings related to issues not previously noted by the internal audit program and repeat
AUDITING
findings from the previous year. An organization also

should include repeat findings that resulted from an
external audit.
Points added for value-add

findings / TABLE 1
These points are added or subtracted from the base

score (see Tables 1 and 2) using a five-point rating
scale:
Five is very good or the best possible.
Four is above average.
Three is minimally acceptable.
Value add
Points
Description
+5
Observation that lead directly to $1,000+ lean savings.
+2
Observation that lead directly to $1-$1,000 lean savings.
+0.5
Two needs improvement.
Opportunity for improvement that is implemented by area

management.
One is very poor.

Zero is nonexistent or almost nonexistent.
These definitions should be used to help score each
category. The sum of these scores is converted to a
100% scale where 80% or greater meets the goal, 60% is
Points deducted based on results

of external audits / TABLE 2
minimally passing and 90% or greater (a minimum rating of three out of five in every category) is considered
excellentor delightful on the Kano model.
Reality check
Points
Description
Each major finding against audit program from outside audit.
Each major finding from outside audit that was previously

identified internally.
Each major finding against quality management system from

outside audit.
resources needed to carry out the mandates of their
Each minor finding against audit program from outside audit.
programs. After an organization defines its ratings,
Each repeat finding from previous year.
This assessment model allows an organization to

define each rating according to its guidelines. Similarly, the users decide what is adequate or more-thanadequate training for auditors, including the level of
the model should be consistently applied to provide

results that can be analyzed and used as input to the
continuous improvement program.
After my audit program went through this rating
The audit cycle
process, I looked at the score and found the initial rat-
An audit program manager (APM) develops plans
ing reflected my first impression of the program when
based on organizational, site and audit program goals,
I arrived at the site. The improvements I made during
which include various aspects of compliance, improve-
my first year resulted in a better score, and it supported
ment and risk management. The APM may receive indi-
my anecdotal and subjective opinion of the programs
vidual audit plans for review and approval, but this de-
status at that time.
pends on an organizations policy and the experience

of the lead auditor.
The APM drives the audits execution phase by pro-
The evaluation forms elements were chosen because theyre as objective as possible and likely to be
consistent on a yearly basis.
viding policies, procedures, resources and credentialing requirements, and he or she will include this in the
Other factors
auditors assignments. APMs receive reported audit
Note that there are other important measures of an
results from lead auditors, and they analyze those find-
audit programs success not included in this model.
ings and report them to site management.
This is because there are factorsbeyond how robust
Responses to the audit are included as input in de-
an audit program isthat might be involved in its im-
velopment of future plans. This entire cycle (see Online
provement: for example, a yearly reduction in custom-
Figure 1, which can be found on this articles webpage
er audit findings.
at www.qualityprogress.com) is repeated with momen-
Other possible reasons for improvement that are
tum from ongoing revisions of goals and objectives,
unrelated to an audit programs performance include:
including analysis of data provided by the audit results.
different auditors, stricter clients, improvement in the
quality management system or luck of the draw (an au-
components to meet your organizations needs, and use
dit only takes a sample after all).
it as an assessment of your assessment program. QP
Even other factors, whether theyre minor or major,

can contribute to a reduction of internal audit findings,
REFERENCE
1. Kano Model Tutorial, ASQ.org, http://tinyurl.com/kanomodelasq.
and its difficult to consistently quantify monetary savings from findings.

These key performance indicators should, however,
improve yearly as your audit programs rating and the
program itself improve. Learn how to use this evaluation tool, and read the sidebar Case In Point, which
illustrates an example of an audit program before and
after improvements were made using this model. You
can use the evaluation form in Figure 2 as a guide. Adjust the ratings weights and add, change or remove
CASE IN POINT
Here is an example of how to assess an audit program based

on existing records. Newly certified organization ABC was having trouble getting its internal audit program off the ground.
A consultant was hired to improve the internal quality audit
program after the organization received findings (one major and
one minor) against it in each of its two customer audits during
the preceding year. The auditors had received formal training,
and there were no dedicated auditors; auditing was a secondary job function.
After reviewing ABCs records, the consultant noted the following:
1. The audit schedule for the previous year was not completed
until June.
2. Only seven of 17 scheduled audits were conducted.
3. There was objective evidence that only one of two opportunities cited was followed up on.
4. The status of scheduled audits was not tracked.
5. Audit forms were completed inconsistently from person to
person.
6. Auditor meetings were not held.
7. Audit results were not regularly reported.
8. Training records were available only for four of six current
auditors.
9. Audit forms were poorly designed and did not logically flow.
10. Audit procedures were unclear and insufficiently detailed.
The consultant interviewed the existing auditors, and many
expressed dissatisfaction with their levels of training. All
confessed to occasional confusion about how to classify audit
findings, how to complete various audit working papers and
when to pursue formal corrective action. They said it was due to
unclear work instructions and poorly designed forms. Some were
concerned with having too many audits to do along with their
regular workloads.
LANCE B. COLEMAN SR. is a quality engineer and lean

program coordinator at The Tech Group in Tempe,
AZ. Coleman holds a degree in electrical engineering technology from the Southern Polytechnical
University in Marietta, GA. A senior member of ASQ,
Coleman is an ASQ-certified quality engineer, Six
Sigma Green Belt, quality auditor, biomedical auditor
and an Exemplar Global quality management system
principal auditor. Coleman is the author of Advanced Quality Auditing: An
Auditors Review of Risk Management, Lean Improvement and Data Analysis
(ASQ Quality Press, 2015). He is an instructor for ASQs quality auditor
certification refresher course and is the newsletter editor for ASQs Lean
Enterprise and Audit Divisions.
Before beginning a root cause and corrective action process analysis, the consultant rated ABCs internal quality audit
program to provide an objective baseline for comparison after
improvements were implemented. Figure 3 (p. 44) shows the
results of the assessment. A score of 60 is minimally acceptable,
80 or better is the goal and a score of 90 or higher is delightful.
With a rating of 23% (based on the information from ABCs
records), ABCs audit program was in the dissatisfaction quadrant
of the Kano model (see Online Figure 2, which can be found on
this articles webpage at www.qualityprogress.com).
The next year, the following changes were implemented:
Two new auditors were trained, and one worked on off shifts.
Two of the existing auditors received refresher training.
Portions of two audits were conducted during off shifts.
The standard operating procedure for audits was completely
rewritten.
Audit forms were revised, and auditors were trained to address previously cited deficiencies.
These changes led to the following results from subsequent
customer audits. There were no major audit findings against the
quality management system, and there wasnt any nonconformance issued against the audit program itself. Figure 4 (p. 45)
shows the results of the following years audit program evaluation.
The improvements made to the audit program were substantial, and as expected, they were reflected in the greatly improved
score. The new rating was more than three times greater than the
original scorewell above minimally acceptable requirements
and within the margin of error for attaining the goal of 80%.
The score was in the must-be quadrant of the Kano model
(see Online Figure 2). There were still improvements that could
be made, and some areas low scores could easily be used as
a roadmap for improvement and delightful performance in the
future. L.C.
AUDITING
Audit system evaluation form
/ FIGURE 2
Audit system evaluation

Date:
Planning (40%)
___ 5%All audits are scheduled that should be scheduled (per requirements of the standard, regulation or internal policies).
___ 5%All scheduled audits were conducted.
___ 5%Percentage that were on time.
___ 5%All nonscheduled audits (not on the annual schedule, but scheduled to address a concern that was identified)
wereconducted.
___ 5%Annual audit plan was approved by site management.
___ 5%Audit program is tied to quality management system (QMS) evaluation metrics and corporate goals.1
___ 5%Individual audit plans were approved by lead auditor or quality management with input from process owners.
___ 5%Audit program is well integrated within the risk management program.
Reporting, records and analysis (30%)
Reporting10%
___ Reported to site-level management.
___ Reported to quality manager.
Data analysis10%
___ Reported data regularly analyzed and acted on.
Records10%
___ Records maintained (audit reports).
___ Records maintained (training records).
___ Records maintained (quarterly or annual summary reports).
Implementation and results (30%)
___ 5%Do we audit across all operating shifts?
___ 5%Is there an appropriate level of auditor training (requirements + actual)?
___ 5%Are an appropriate amount of audits dedicated to improvement activities?2
___ 5%Is a documented and structured method for evaluating the validity and classification of findings?
___ 5%Are there adequate resources?
___ 5%Are varying types of audits used, such as process, product, trace, system or element?

Subtotal = potentially 100%
Value add percentage
Reality check percentage
Total
Notes
1. ISO 9001:2008 and ISO 13485:2003 requires an audit program to monitor the effectiveness of a QMS, but it isnt explained how you
know whether the QMS is effective. Its not enough to simply state that a lack of findings demonstrates that the QMS is effective.
Metrics should be developed to assess the QMS, and the audit program should monitor those metrics in addition to compliance to
policies and procedures.
2. Improvement auditing is assessed against criteria that could be driven by compliance or a desired future state. It also could evaluate an
area for muda (nonvalue-add wastes) or monitor project results against predetermined milestones.
Organization ABCs pre-improvement evaluation
/ FIGURE 3

Date:mm/dd/yyyy
17% Planning (40%) 17 of possible 40 total rating x 40% = (17/40) x 0.4 = 0.17 = 17%
3 5%All audits are scheduled that should be scheduled (per requirements of the standard, regulation or internal policies).
Yes, but were points deducted because the schedule wasnt released until June.
1 5%All scheduled audits were conducted. Only seven of 17 scheduled audits were conducted.
0 5%Percentage that were on time.
5 5%All nonscheduled audits (not on the annual schedule and scheduled to address a concern that was identified)
wereconducted. There were no nonscheduled audits (full credit).
3 5%Annual audit plan was approved by site management. It was developed by the quality assurance manager.
0 5%Audit program is tied to quality management system (QMS) evaluation metrics and corporate goals. Not done.
3 5%Individual audit plans were approved by lead auditor or quality management with input from process owners.
No input was provided from process owner.
2 5%Audit program is well integrated within the risk management program. Its informally tied to the risk management program.
13% Reporting, records and analysis (30%) 13 of possible 30 total rating x 30% = (13/30) x 0.3 = 0.13 = 13%
Reporting10%
1 Reported to site-level management. Only the number of audits conducted were reported during the management review.
5 Reported to quality manager. Results were reported to the process owner, and the quality manager signs each report for closure.
Data analysis10%
0 Reported data regularly analyzed and acted on.
Records10%
5 Records maintained (audit reports). Hard and electronic copies of audit reports and schedule were maintained.
2 Records maintained (training records). Some training records were missing.
0 Records maintained (quarterly/annual summary reports). Not done.
10% Implementation and results (30%) 10 of possible 30 total rating x 30% = (10/30) x 0.3 = 0.10 = 10%
0 5%Do we audit across all operating shifts? Auditors work and audit only during the day shift.
2 5%Is there an appropriate level of auditor training (requirements + actual)?
Auditors were trained, but requirements were not specified.
0 5%Are an appropriate amount of audits dedicated to improvement activities?
Only compliance-based audits were conducted.
3 5%Is a documented and structured method for evaluating the validity and classification of findings? They could be clearer.
3 5%Are there adequate resources? There were adequate resources to implement the program.
2 5%Are varying types of audits used, such as process, product, trace, system or element? Only element audits were done.
40% Subtotal = potentially 100%
+ 1% Value add percentage One point was added to score for an identified opportunity that was implemented.
18% Reality check percentageFive points were deducted for one major audit program finding, -12 for six major QMS findings,
and -1 for one minor audit program finding.
23%Total
AUDITING
Organization ABCs post-improvement evaluation
/ FIGURE 4

Date:mm/dd/yyyy
31% Planning (40%) 31 of possible 40 total rating x 40% = (31/40) x 0.4 = 0.31 = 31%
5 5%All audits are scheduled that should be scheduled (per requirements of the standard, regulation or internal policies).
5 5%All scheduled audits were conducted.
4 5%Percentage that were on time. 80% of audits conducted on time; including overflow from previous year.
5 5%All nonscheduled audits (not on the annual schedule and scheduled to address a concern that was identified)
wereconducted. There were no nonscheduled audits (full credit).
4 5%Annual audit plan was approved by site management. Attachment in standard operating procedures was approved by
sitemanagement.
1 5%Audit program is tied to quality management system (QMS) evaluation metrics and corporate goals.
Improvement in this area was initiated.
4 5%Individual audit plans were approved by lead auditor or quality management with input from process owners.
Now they are input from process owner.
3 5%Audit program is well integrated within the risk management program. Findings are now classified by risk.
26% Reporting, records and analysis (30%) 26 of possible 30 total rating x 30% = (26/30) x 0.3 = 0.26 = 26%
Reporting10%
4 Reported to site-level management. They provided quarterly and annual summary reports, and input to management review.
5 Reported to quality manager. Results were reported to process owner, and quality manager signed each report for closure.
Data analysis10%
2 Reported data regularly analyzed and acted on. Improvement in this area was initiated.
Records10%
5 Records maintained (audit reports). Hard and electronic copies of audit reports and schedule were maintained.
5 Records maintained (training records). All training records were current and available.
5 Records maintained (quarterly/annual summary reports).
16% Implementation and results (30%) 16 out of possible 30 total rating x 30% = (16/30) x 0.3 = 0.16 = 16%
2 5%Do we audit across all operating shifts? Parts of two audits conducted on off shift.
4 5%Is there an appropriate level of auditor training (requirements + actual)?
1 5%Are an appropriate amount of audits dedicated to improvement activities? Improvement in this area was initiated.
3.5 5%Is a documented and structured method for evaluating validity and classification of findings?
3.5 5%Are there adequate resources? There were adequate resources to implement the program.
2 5%Are varying types of audits used, such as process, product, trace, system or element? Only element audits were done.
73% Subtotal = potentially 100%
+ 6% Value add percentage Six points were added to the score for identified opportunities that were implemented.
0% Reality check percentage
79%Total
Like
Father,
Like
Son
Looking back at the Ishikawa
familys contributions to
qualitys heritage
In 50 Words
Or Less
Ichiro Ishikawa and

Kaoru Ishikawathe
father-son quality duo
from Japanmade lasting contributions that
changed the world of
quality.
Both influenced thought
leaders and the quality
community and helped
establish a foundation
for Japanese total quality management, as well
as quality thinking and
methods worldwide.
THERES SOMETHING UNIQUE and

and special about the contributions the Ishikawa family
made to the global quality movement and its advancement in the development and applications of quality
thinking and methods.
Kaoru Ishikawa (1915-1989) is universally known and
revered within the quality community. Lesser known are
the significant contributions made by his father, Ichiro
Ishikawa (1885-1970), to the establishment of a modern
quality movement in the period after World War II.
HISTORY
by Gregory H. Watson
This article provides the history of these contributions by the Ishikawa father and son duo and positions
their contributions as important components in establishing a foundation for Japanese total quality management (TQM).
Exceptional father
The Ishikawa familys roots are in Tokyo where Uichiro
Ishikawa (1862-1919), father of Ichiro Ishikawa, managed the Kanto Sanso (Kanto Acid and Soda) company.
After Ichiro Ishikawa graduated from the Imperial
During these pioneering years of JUSE, Ichiro Ishika-
University of Tokyo and served there as an assistant pro-
wa played an important role in convincing senior manag-
fessor in applied chemistry for several years, he joined
ers of major Japanese companies to pursue quality as a
his fathers company to begin a long management ca-
top-priority strategy for the reconstruction of Japanese
reer in the Japanese chemical industry, where he even-
industry. In recognition of his lifetime contributions to
tually became an industry leader during the war years
Japan and its industry, Ichiro Ishikawa was decorated
and served as president of Nissan Chemical Industries
with the Grand Cordon of the Order of the Paulownia
and director of the Japanese Association for Chemical
Flowers of the Rising Sun by the emperor.

Ichiro Ishikawas role as JUSE chairman was not
Industries.
Following this period, he transitioned into a cross-
merely an honorary position without real responsibility.
industry leadership role; first as chairman of the Japan
His focus was to convince Japanese business leaders of
Industrial Association (JIA) in 1946, and then as the first
their responsibility to pursue quality as a key business
president of the Keidanren (Japanese Federation of Eco-
objective for the recovery of Japans economy during the
nomic Organizations, or JFEO), a position he held from
postwar reconstruction years. In many ways, he acted as
1948 to 1956.
the kuroko, or the player who is dressed in black clothing
When the Union of Japanese Scientists and Engineers
in Japanese kabuki dramas to facilitate the actions on
(JUSE) was established in mid-1946, the executive com-
the stage by the primary actors who are the visible focus
mittee was initially organized with Yoshitomo Tatumi
of the onlookers.
as the founding president. From the start, it was JUSEs
My belief in Ichiro Ishikawas role has been deduced
intention to maintain a close relationship with industry
through a logical examination of evidence presented
by inviting a recognized leader to serve as its chairman.
through the Deming Prize records.
JUSE top management then invited Ichiro Ishikawa
The effectiveness of Ichiro Ishikawas interventions
to serve as its initial chairman. On July 20, 1947, he met
and a measure of his influence has been solidified by the
with Kenichi Koyanagi, the first managing director of
fact that he served as the first chairman of the Deming
JUSE (1946-1965), and accepted the nomination. Since
Prize Committee (established in 1951) and at the first
the initial installation of Ichiro Ishikawa as the founding
Deming Prize Award Ceremony in September 1951. There,
JUSE chairman, JUSE has traditionally requested that
the Deming Application Prize was awarded to four major
the chairman of the Keidanren or JFEO serve concur-
Japanese organizations: Fuji Iron & Steel Co., Showa Den-
rently as its chairman based on this precedent.
ko K.K., Tanabe Seiyaku Co. and Yawata Iron & Steel Co.
KAORU ISHIKAWA
Career milestones
President, Japanese
Assistant professor,
Society for Quality
faculty of engineering,
Control (two-year
University of Tokyo.
term).
BORN: JULY 13, 1915
1939
1947
Doctorate, department
of applied chemistry,
faculty of engineering,
University of Tokyo.
1960
President, Musashi
Institute of Technology
(currently Tokyo City
University).
1974 1976 1978 1981
Professor, faculty
of engineering,
University of
Tokyo.
Professor
emeritus,
University of
Tokyo.
Professor,
Tokyo
University of
Science.
President,
International
Academy for
Quality (IAQ),
three-year
term.
QC Circle Koryo, General

Principle of the
QC Circle, QC Circle
Headquarters, Union
of Japanese
Scientists and
Engineers (JUSE).
1980
1982
What Is Total
Quality Control?
The Japanese
Way, Prentice
Hall Inc.
1985
Guide to Quality Control (fourth edition),

Asian Productivity Organization.
Books
published
in English
HISTORY
In the following year, eight additional organizations
leaders involved in industry and academia is clear when
received this award: Asahi Chemical Co., Furukawa
examining the list of individual awardees of the Deming
Electric Co., Nippon Electric Co., Shionogi & Co., Shion-
Prize in 1952. Seven members of the JUSE Quality Re-
ogi & Co., Takeda Chemical Industries, Toyo Spinning
search Group, chaired by Shigeru Mizuno, were recog-
Co. and Kyushu Cloth Industry Co.
nized with this award: Tetsuichi Asaka, Kaoru Ishikawa,
During the remainder of Ichiro Ishikawas tenure as
Masao Kogure, Masao Goto, Hidehiko Higashi, Shin Mi-
JUSE chairman, three to four organizations received
ura and Eizo Watanabe. Encouraging these individuals,
this award each year. Many of these recipients came
and, in particular, Ichiro Ishikawas son Kaoru Ishikawa,
from the chemical industry, and were major Japanese
to dedicate their intellect and energy to developing qual-
organizations that you would expect to be active in the
ity in Japan was an exceptionally important strategy that
Keidanren, or were critical infrastructure industries that
led to efficient management.
were necessary for the reconstruction of a broad-based
While my arms length observations of the actual activ-
manufacturing capability for rebuilding the Japanese
ities of this time are perhaps not totally accurate, it seems
economy.
there was a strong role for an executive leader of the stat-
In the year following his term as chair, there were no
ure of Ichiro Ishikawa to serve in a persuading way to
Deming Prize Award recipients. While no strong conclu-
engage industry and individuals to support Japans fledg-
sion can be drawn from this information, it appears that
ling quality movement. It is clear, however, that the father
there might have been an invisible hand operating be-
influenced his son to serve in this capacity. Perhaps, in
hind the scenes that caused company executives to pur-
the future, a researcher will search the JUSE archives to
sue quality in the same way as Adam Smiths invisible
determine the validity of this personal belief.
hand guides the benefits to the whole of society based on
Exceptional son
the actions of an individual.1

Another component of Japans quality effort was the
I have expressed my deep respect for the contribu-
engagement of top-level executives, which was combined
tions of Kaoru Ishikawa in an earlier article2 in which
with a strategy adopted by JUSE of providing knowledge
I explained how my initial introduction to quality came
and expertiseexternally through the lectures by qual-
through the study of his approach to reviewing projects
ity gurus W. Edwards Deming and Joseph M. Juran, and
for quality improvement in a series of videos produced
through developing internal experts on quality.
by Hewlett-Packard in the early 1980s.
Evidence of this strategy to get Japanese thought
Introduction to
Quality Control
(third edition),
3A Corp.
1989
Although I never met him, Kaoru Ishikawa became a
Blue Ribbon Medal

of Honor, Japanese
government.
Eugene L. Grant
Award, ASQ.
Walter A. Shewhart
Medal, ASQ.
1952 1971 1977 1982 1983
Deming Prize
for Individuals,
Deming Prize
Committee.
Honorary Member,
Japanese Society
for Quality Control.
Academician
Emeritus,
IAQ.
Establishment of
the QC Circle Kaoru
Ishikawa Award, QC
Circle Headquarters,
JUSE.
Honorary member, IAQ.
1986 1987 1988 1990 1993 1994 2007
Honorary
member,
ASQ.
Order of Sacred
Treasure, Gold
and Silver Star,
Japanese
government.
Establishment
of the Kaoru
Ishikawa Medal,
ASQ.
DIED: APRIL 16, 1989
Establishment
of the Founders
Medal, IAQ.
EDITORS NOTE
Honors and awards
For more information about Kaoru Ishikawas life compared to the parallel development of quality control, see
Postscript: A Parallel Chronology of Dr. Ishikawas Life
and Japans TQC at www.juse.or.jp/english/archives/.
virtual mentor to me because I realized how profoundly
systemic effects of quality and its cultural adaptation
he shaped how I formulated my own approach to quality
by focusing on the core components that are universal
consulting. He has greatly advanced the development of
elements and may be applied in any industrial concern
quality by managing its transition across generations and
or cultural context.
Kaoru Ishikawas professional life was dedicated to
across cultures.
Through the development of a collective system of
developing and guiding the fledgling Japanese quality
qualitytotal quality management (TQM) the Japa-
movement and sharing with the rest of the world the les-
nese wayhe demonstrated an appreciation for the
sons learned during its quality journey.
1915
JAPAN CELEBRATES CENTENNIAL

OF KAORU ISHIKAWAS BIRTHDATE
This year, Kaoru Ishikawa would have turned 100, and Japan is
mittees, along with the three non-Japanese recipients of the W.
honoring his legacy.
Edwards Deming Distinguished Service Award for Dissemination
In recognition of this anniversary and to memorialize his

lifelong quality career, the Union of Japanese Scientists and
Engineers (JUSE) has joined with the Japanese Standards As-
sociation (JSA) and the Overseas Human Resources and Industry

Development Association (HIDA) and others in a Birth Centenary
Commemoration Project. This project is resolved to preserve
and communicate his legacy and exceptional contribution to the

quality movement that had substantial impact on the industrial
management in Japan and the rest of the world during his illustrious career.
This project has two objectives:
1. Transfer Kaoru Ishikawas achievements and philosophy to
the next generations around the world.
2. Demonstrate how his philosophy, ideas, methods and activities can be effective today and will continue to be relevant
tomorrow.
Three major activities are planned this year:
1. The 1993 book Kaoru IshikawaThe Man and Quality Control,
and Promotion of Japanese Total Quality Management (over-
seas): Janak Mehta (India), Kan Trakulhoon (Thailand) and the
author of this article (United States and Finland), who was the
first recipient of this award.
Some of Kaoru Ishikawas accomplishments include:

Founding the Japanese Society for Quality Control (JSQC) in
1970 with Shigeru Mizuno and Tetsuichi Asaka with Yasusaburo Hara as its first president.
Establishing JUSE and JSQC programs for the Deming Prize,
three monthly academic journals on quality, and various
quality conferences and symposiums, which continue to be
conducted.
Founding the International Academy for Quality with Armand
V. Feigenbaum (United States) and Walter A. Masing (Germany).
Organizing international activities for quality circles (QC). He is
known as the father of the QC.
Kaoru Ishikawa served as the leader of overseas QC study
published by Keiko Ishikawa, Kaoru Ishikawas widow, has
teams of Japanese executives and contributed to international
been translated into English by a number of volunteers and is
cooperation in quality control under the sponsorship of various
now available for download at: www.juse.or.jp/english/
Japanese organizations.
archives.
2. A new collection of papers about Kaoru Ishikawa will be published electronically on the same JUSE website.
3. A commemorative symposium Sept. 28 at the University of
He visited China, Taiwan, Korea, Thailand, India, the United

States, Czechoslovakia, Finland, France, Sweden, Switzerland,
Brazil and the United Kingdom to conduct seminars and conferences to transfer Japanese TQM to other countries. He wrote 31
Tokyo to celebrate the centennial anniversary of his birth.
books and more than 600 papers on various topics related to
The chairman of the executive committee is Noriaki Kano,
quality. G.H.W.
Kaoru Ishikawas principal disciple and an honorary member of

ASQ. Serving as vice chairs are Ichiro Kotsuka (Managing Director
and Secretary General, JUSE) and Kazuyuki Suzuki (past President of the Japanese Society for Quality Control).
In addition, many Japanese business leaders and former
students of Kaoru Ishikawa are members of the organizing com-
EDITORS NOTE
For more information about Kaoru Ishikawas teachings, see these ASQ open-access
articles:
Kondo, Yoshio, Kaoru Ishikawa: What He Thought and Achieved, a Basis for Further Research, Quality Management Journal, July 1994, pp. 86-91. http://asq.org/data/
subscriptions/qmj_open/1994/july/qmjv1i4kondo.pdf.
Watson, Gregory H., The Legacy of Ishikawa, Quality Progress, April 2004, pp. 54-57,
http://asq.org/data/subscriptions/qp/2004/0404/qp0404watson.html.
HISTORY
Furthermore, through his own writings and publica-
faith. In this tradition, each person should leave the
tions and through the research that he encouraged oth-
world a better place as a way of honoring the wisdom
ers to pursue, Kaoru Ishikawa assured that learnings
that has been gathered by ancestors, by passing on and
from Japan would be transferred to the West because
preserving this knowledge for future generations.
the Japanese TQM research and study committees of the
Each person will contribute to the continual cultiva-
1980s translated their final reports into English to share
tion and nurturing of this knowledge to create an ever-
with the rest of the world.
more refined state of being. The responsibility of each

of us is to leave the world a better place as a result of
Collaborative leadership
our experience as humans. Perhaps this implicit cultural
It also is clear that Kaoru Ishikawa was not solely re-
mindset of Japanese thinking is best described in a guid-
sponsible for all of these results. Early development of
ing precept of Japanese business:
quality in Japan was indeed a collaborative effort. The
Contribute to developing the welfare of the country
founding generation of Japanese quality thought leaders
by working together, regardless of position, in faithfully
included three men who served as prime movers within
fulfilling your personal duty and show gratitude for the
the early Japanese quality community: Shigeru Mizuno,
contributions of others in things that are both great and
Tetsuichi Asaka and Kaoru Ishikawa.
small; in both thought and deed. In such a system of liv-
Shigeru Mizuno led the initial Quality Research
ing, the responsibility of each generation is to develop
Group, which interpreted the words of Deming and Ju-
the following generation so that it is capable of fulfill-
ran to help structure a uniquely Japanese approach to
ing its own responsibility and extending the tradition of
companywide quality control.
learning and doing.
Tetsuichi Asaka served as a consultant and quality
This was accomplished by Kaoru Ishikawa because he
coach who guided Japanese industry leaders and their
was a mentor for a second generation of Japanese qual-
companies in a disciplined approach to quality.
ity thought leaders: Yoshio Kondo, Takanori Yoneyama
Kaoru Ishikawa contributed to the development
and Genichi Taguchi. The current generation of Japanese
of quality methods and shaped the formal structure of
quality thought leaders also have been his disciples, stu-
Japanese quality infrastructure through his leadership in
dents or colleagues. They include Hitoshi Kume, Noriaki
JUSE and development of a national and global structure
Kano, Shoji Shiba and Yoji Akao.
for the encouragement and promotion of Quality Control (QC) Circle activities.
Kaoru Ishikawa became Japans representation when
speaking about quality through his international activities and by interpreting the Japanese total quality philosophy, tools, methods, success stories and case studies.
In this way, from one generation to the next, the

Ishikawa family contribution has enriched the global
quality community and, in turn, improved the quality of
life for much of humanity.
Exceptional father, exceptional son: Quality professionals remember your contributions and thank you with
His achievements in global quality consulting, backed
deep gratitude for your gifts to our current knowledge
by the exceptional performance of Japanese companies
and capability, which would not have been achieved
that were supported by his national quality colleagues,
without your diligent efforts. To paraphrase Isaac New-
created Japans strong reputation for quality perfor-
ton, If we have been able to see further, it is because we
mance.
have stood on the shoulders of giants. QP
This collaborative approach to quality has served Japan well. Clearly, the pivotal role in the global dissemination of Japanese quality was the key personal contribution of Kaoru Ishikawa.
The ongoing legacy

New science is built on the contributions of past scientists. The same is true in the global quality movement.
REFERENCES
1. Adam Smith, The Wealth of Nations, 1776.
2. Gregory H. Watson, The Legacy of Ishikawa, Quality Progress, April 2004,
pp. 54-57.
GREGORY H. WATSON is chairman of Business Excellence

Solutions Ltd. in Espoo, Finland. He is an ASQ past chair
and fellow, and a past president and honorary member
of the International Academy for Quality.
What is the responsibility of one generation for the next?

This question is a focus that is inherent in the Shinto
WORLD
QUALITY
MONTH
2015
November
worldqualitymonth.org
Get Involved!
Highlight
Your Success
A time to show efforts
and achievements!
Spread the Word
Learn From Others
Raise the global voice

of quality!
Join the celebration!
Visit worldqualitymonth.org
MEASURE FOR MEASURE
BY CHRISTOPHER L. GRACHANEN
Where Do You Fit?

Updating the U.S. Standard Occupational Classification System
MANY READERS may not be familiar
U.S. censuses. This disparity prompted a
used to determine which occupations are
with the U.S. Department of Labors Stan-
partnering of ASQs Measurement Qual-
included in the majority of those publica-
dard Occupational Classification (SOC)
ity Division, the National Conference of
tions. One of the major publications used
System. According to its website, the SOC
Standards Laboratories International and
by educators for this purpose is the Oc-
is a:
the Measurement Science Conference to
cupational Outlook Handbook (OOH). The
create a submission for calibration and
following is from the OOH Teachers Guide
system used by federal statistical agencies
metrology job titles and descriptions to be
webpage:
to classify workers into occupational catego-
added to the 2010 SOC.
ries for the purpose of collecting, calculating

or disseminating data. All workers are classified into one of 840 detailed occupations
according to their occupational definition. To
facilitate classification, detailed occupations
are combined to form 461 broad occupations, 97 minor groups, and 23 major groups.
Detailed occupations in the SOC with similar
Unfortunately, SOC administrators ulti-
The Occupational Outlook Handbook (OOH)
mately rejected this submittal on the basis
is an online career guidance resource that
of insufficient substantiation of:
provides information on hundreds of occupa-
1. Unique tasks performed
tions in the United States. Updated every
2. Sufficient population numbers warranting recognition in the SOC.

Because the SOC does not contain job
job duties, and in some cases skills, educa-
titles and descriptions for calibration and
tion, and training, are grouped together.1
metrology practitioners, there are
two years by the Bureau of Labor Statistics,

the OOH allows students to explore different
aspects of occupations by clicking on the
following tabs:
What workers do on the job.
essentially no standardized
Discovering disparity
definitions for these oc-
The SOC is updated about every 10 years
cupations. Standard-
(the last update was in 2010), with the
ized occupational
next update slated for 2018. I first became
definitions are used
aware of the SOC in 2002 when I was look-
to homogenize titles
ing for demographic information regarding
and descriptions
the population of calibration and metrolo-
across civil and
gy practitioners in the United States to es-
governmental con-
timate the number of potential candidates
tracts, pay grades
who may elect to become certified if an
scales and position
ASQ calibration and metrology certifica-
qualifications.
tion program existed. The numbers were
It is also important
needed to justify a proposal for creating
to note that to assist
the program. The proposal was eventually
young adults in making
accepted by ASQs Board of Directors and
well-informed career
culminated in the creation of the certified
decisions, educators
calibration technician program in 2003.
frequently reference the
After examining the SOC, I learned it
U.S. Department of Labor
does not recognize job titles and de-
publications to provide
scriptions for calibration technicians,
information about oc-
calibration engineers or metrologists,
cupations and forecasts
which means information about these
on future job growth. The
occupations is not being collected via
SOC listing is frequently
MEASURE FOR MEASURE

Work environment.
Education, training and other qualifications needed to enter the occupation.
Standard Occupational Classification

System search / FIGURE 1
Pay.
Projected employment change and job
prospects from 2012 to 2022.
Similar occupations.
Contacts for more information.
Quality Engineer
As a teacher, you are in a position

to help your students plan their future.
Through the OOH, students can access
valuable occupational information that
can help them make career choices. By
familiarizing yourself with the features of
the OOH, you will be in a position to quickly
Results for quality engineer
/ FIGURE 2
and effectively help your students use this

valuable tool.2
Many, such as those in the calibration

and metrology fields, are faced with large
numbers of baby boomers retiring from
the workforce along with a critical short-
Results for quality technician
/ FIGURE 3
age of young adults entering the field. It

is this dire situation that prompted a new
submittal of calibration and metrology
titles and job descriptions for inclusion
in the 2018 SOC, taking into consideration lessons learned from the 2010
submittal. It is anticipated that later this
year, the U.S. federal register will publish
the SOCs decision on adding calibration
and metrology occupations for the 2018
yields a single result, shown in Figure 2.
quality profession, and arguably, this
A query of the SOC website for quality
warrants a call for action by ASQ leaders
Bigger quality picture
technician yields two results, shown in
to rectify this disparity. QP
Some readers may be asking what the
Figure 3.
SOC.
SOC position on inclusion of calibration
Furthermore, the alphabetical list of
and metrology job descriptions has to
SOC occupations does not list job titles
do with mainstream quality occupations.
or descriptions for quality engineer,
To answer that question, all you need to
engineer, quality, quality technician,
do is search the SOC website for quality
and technician, quality. You can deduce
engineer, shown in Figure 1. The search
the implications of this situation on the
MORE ON MEASUREMENT
Read more Measure for Measure columns by Christopher L. Grachanen

and other metrology experts by visiting the Departments & Columns tab
at www.qualityprogress.com.
REFERENCES
1. Standards Occupational Classification System, Bureau
of Labor Statistics, U.S. Department of Labor, www.bls.
gov/soc/home.htm.
2. Bureau of Labor Statistics, U.S. Department of Labor,
Teachers Guide, Occupational Outlook Handbook,
www.bls.gov/ooh/about/teachers-guide.htm.
CHRISTOPHER L. GRACHANEN is
a distinguished technologist and
operations manager at HewlettPackard Co. in Houston. He earned
an MBA from Regis University in
Denver. Grachanen is a co-author
of The Metrology Handbook (ASQ
Quality Press, 2012), an ASQ fellow,
an ASQ-certified calibration technician and the treasurer of
the Measurement Quality Division.
Subscribe to Standards Connection

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Standards Connection will keep you a step ahead. By subscribing to Standards
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TRAINING
CERTIFICATION
CONFERENCES
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PUBLICATIONS
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QUALITY IN THE FIRST PERSON
BY DEREK PURDY
Who Cares?
A brothers lesson resonates in doing jobs right the first time
A SOLID WORK ethic is especially impor-
first time. On this occasion, he was in a
workers. What happened to doing a job
tant for anyone in the quality profession.
hurry and didnt bother to use fall protec-
right because its the right thing to do?
Because the word quality is in your job
tion.
What about taking pride in your work?

I realized some people never learned
title, people hold your quality of work to a
He ended up accidently stepping on a
higher standard. This is true for big things,
fiberglass skylight and falling 30 feet be-
the importance of a work ethic. I learned
of course, but also for day-to-day items.
fore an upward-facing handle of a butterfly
that lesson early in lifehelping my
valve impaled his lower leg. If that valve
brother fix his run-down, old car.
Do you follow up on tasks and track

them to completion? Do you proofread
had been mounted just a few inches lower,
emails before hitting send? Do you take the
hed have died instead of just being injured.
time to really understand the documents
Another time, a worker was dispatched
Setting the example

When I was in grade school, my brother
you sign? Do you show up and choose to
to the manufacturing floor to weld a leak-
Craigs first car was a clunker he borrowed
be present in the meetings you attend? All
ing catch pan. When I went to verify the
from my grandfather. It was 1954 Pontiac
of these things send a message about you
job was complete, I saw a quality of work
that had been rusting in a barn. The deal
as a quality professional, and they either
that wouldnt have survived the scrutiny of
was: Craig could use it as long as he liked,
bolster or tarnish your image.
my eighth-grade shop teacher. Besides the
but he had to return it in working condition.
I once worked in a 60-year-old manu-
hideous, wandering weld bead, there were
It didnt take long to see hed gotten a
facturing facility. In its heyday, it was
visible holes in the seam, and the pan was
lousy deal. The transmission was on its
state of the art, but when I arrived, it was
still leaking. The workers whod asked for
last leg, the brakes were going and the car
dilapidated. Upper management was unin-
the repair rightly complained that they still
had countless other problems.
terested in investing in it, and that attitude
had a mess to deal with. Nonetheless, the
was reflected in the crews demeanor.
welder had signed off on the work ticket.
One day, a maintenance worker was
Where does this attitude come from?
One evening, I went outside and saw

it in the driveway with an extension cord
snaking from the garage to the car. The
assigned to repair equipment on the roof.
I understood how demotivating upper
1954 Pontiacs had three-on-the-tree gear-
Hed been up there many times to fix the
managements view could be, but these
shifts (one thats mounted to the steering
same piece of equipment, and you have to
examples of laziness affected the safety
column), and there was an issue with the
wonder why it wasnt fixed properly the
of the workers themselves and their co-
linkage. Because the cars inner workings

always interested me, I settled in to help
my brother.
After pulling out the steering wheel,
we found an array of electrical wires connecting to the horn, turn signal and other
areas. The wires didnt have modern,
color-coded plastic insulation. They were
uniformly insulated with the same dirty,
cream-colored cloth.
Because the car was a junker, I figured
wed just snip the wires and move on.
Whod care that the horn and turn signals
didnt work? Instead, my brother methodically labeled each wire on either side of
the cut. Eventually, we gained access to
the trouble spot; it took only minutes to
fix the actual gearshift problem.

Daylight faded to full darkness, and the
say Ill do something, Ill do itand do it
tive example so I can pass the lesson on to
well. I take pride in that and in the cred-
a new generation. QP
temperature dropped. Our T-shirts were
ibility it builds. Its something that should
filthy and we were shivering. I held the
be intrinsicnot just for quality profes-
light as my brother put lengths of heat-
sionals, but for everyone.
shrink tubing on the wires, and painstak-
These same principles apply on the
ingly twisted a wire back together and
home front. Now that I have my own kids,
soldered it. He slid the heat-shrink tubing
I feel its especially important to set a posi-
DEREK PURDY is a senior quality

engineer at SI-Bone in San Jose, CA. He
holds a masters degree in engineering management from Old Dominion
University in Norfolk, VA. An ASQ senior
member, Purdy has served as membership chair and vice chair of ASQs Silicon
Valley Section. He is an ASQ-certified
quality engineer and quality improvement associate.
over the joint and shrunk it with a hairdryer. He then slid the cloth insulation over
the tubing and held it with electrical tape.
Anyone whos tried holding a soldering
gun to a free-floating wire with one hand
while feeding solder with the other can understand how this felt like a never-ending
chore.
I noticed the cuts in the wires were
staggered to prevent the bulge created by
the repairs from piling up in one spot. As
a result, the wire bundle fit back down the
steering column and avoided chafing during operation.
After the job was done, Craig tested the
signals and horn to make sure they worked
properly. It was well past 11 p.m. when we
finished. I looked up and asked, Whyd
you go through all that? Grandpa doesnt
care about this car. Hes just gonna put it
No entrance or comprehensive exams
back in the barn. And youre only driving it
Small, interactive classes
until you get something else anyway.
Accelerated, accredited degrees
Doing the right thing when someones

watching is no big deal, Craig said. Its
what you do when nobodys looking that
Degrees include options for LSS

certificate
counts. This isnt my car. Grandpa just let
Innovative, project-based learning
me borrow it. And I agreed to take care of
Weekly interaction with faculty and

fellow students
it. That means returning it at least in the

same condition as I got it. Take pride in your
work; if youre going to do a job, do it right.
Im certain Ive heard that advice many
times before and sinceif its worth doing, its worth doing well. But having such
a naked display of integrity at an early
age helped drive the message home with
greater force than anything I experienced
afterward.
This early lesson has served me well in
my personal and professional life. People
tell me they appreciate knowing that if I
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CAREER CORNER
BY ROSEMARIE CHRISTOPHER AND PAUL DIONNE
Truth Detective
Tips for investigating prospective employers, avoiding duds
WHEN YOURE SEARCHING for a job,
truly valued integrity. CEO intervention
advanced search feature and select the
you dont want to end up working for
will be required to improve ethical deci-
past company category to find people
an organization thats a dud. The U.S.
sion making, and dont delude yourself
who previously worked at the organiza-
by believing you would be immune.
tion. View each profile to get a sense of
unemployment situation has improved,

and the tables are turning back in favor
CheapTheres not much value in tak-
of employees. Even people whove ex-
ing a job if youre not going to receive
employers, use the location, title or other
perienced long-term unemployment are
the resources you need to accomplish
criteria to narrow your search to a par-
re-engaging in their job hunts.
anything meaningful. Research the orga-
ticular department. Good signs include
nizations finances and look for signs of
long stays, promotions and people who
tions as part of employee recruitment
poor pay or a lack of funds. A CFO or
left but came back. Its a bad sign when
and retention. Here are four potential
CEO might be able to reverse the situa-
you see a high number of people who
tion, but few others can.
worked there less than a year.
Employers must consider their reputa-
problems you should investigate at any

organization thats offering you a second-
Bad cultureSymptoms of a bad cul-
how long they stayed there. For large
Interview past employees. You can
round interview:
ture appear in many forms. Its possible
send messages to previous employees via
High turnoverThis can be the result
that people are too busy creating fief-
LinkedIns InMail feature, and ask about
of multiple issues. A strong HR leader
doms that inhibit change, or everyones
their experience at the organization.
might be able to fix a turnover problem
input is required, creating meeting after
Theres a pretty low chance of getting a
but only with sustained support of the
meeting and preventing anything from
response. Few people want to badmouth
CEO.
being accomplished. Poor ethics and fi-
a previous employer, and you can assume
nances may contribute to a bad culture,
a lack of response means the organiza-
organizations leadership will trickle
too. It can cause employees to blame
tion is below average. On the other hand,
down. If you see poor ethical decisions
others for their problems rather than
if you hear back from someone, you may
being made, theyre likely happening
rolling up their sleeves and collaborat-
receive make-or-break information you
throughout the organization. Lower-
ing to reverse the bad situation. Unless
couldnt get elsewhere.
level employees practicing unethical
youre the CEO, youre not going to fix a
behaviors would be fired if their leaders
bad culture.
Poor ethicsThe ethics of an
Check out the organization on Google

Finance or Yahoo Finance. If you dont
know how to read corporate financials,
Uncovering the
issues
ask someone who doeshaving an
Use LinkedIn to see
organization experiences financial highs
how long people stay
and lows. If it doesnt look good, work to
there. When recruiters
understand why theyre in that situation
look at rsums and
and what it would take to change it.
see a string of short
Read employee review sites such
employment stints, they
as Glassdoor and Indeed. Again, most
assume the person is
people will avoid badmouthing a previ-
a job hopper. LinkedIn
ous employer. When someone does, you
gives us the power to
should take note, but read the reviews
turn the tables and
carefully. They may have been faked or
understand an organiza-
embellished. Some HR departments have
tions turnover rate.
been known to post favorable reviews
Use LinkedIns
outsiders perspective can help. Every
of their organizations. Although they
work there, too, its a bit disingenuous.
regulatorssuch as the Federal Avia-
If youre a CEO, CFO or board mem-
Conflicting reviews also may reflect that
tion Administration, National Oceanic
ber, investigate your organization. As the
some employees had good bosses and
and Atmospheric Administration, or
game of talent acquisition heats up, you
others didnt.
U.S. Securities and Exchange Commis-
dont want to be left on the sidelines. QP
Read customer review sites such as
sion. Our organization provides staffing
Yelp, Google and the Better Business Bu-
for U.S. Food and Drug Administration
reau (BBB). On these sites, customers air
(FDA)-regulated businesses. We check
their complaints and report issues with
prospective partners for warning letters
an organizations products or services.
and recalls on the FDAs website (or
Picture yourself working at that organiza-
U.S. Department of Agriculture for food
tion, and distinguish between complaints
recalls).
you would be in a position to address
Some organizations will view a recall
versus ones that would be out of your
or warning letter as a call for improve-
control. When the BBB receives com-
ment, which is good. Others will see it as
plaints, it contacts the chief executives at
government overreach that they must
each organization. On the BBB site, if you
comply with, which is bad. We do not
see a slew of issues that werent resolved
recommend directly raising an issue in
to the customers satisfaction, theres a
an interview. Instead, ask questions that
problem at the top of the organization.
will uncover whether the organization is
Search industry regulators websites. Every industry has its own set of
REFERENCE
1. Employment Situation Summary, Bureau of Labor Statis-
tics economic news release, http://tinyurl.com/t68g.
ROSEMARIE CHRISTOPHER is an
organizational communications
consultant and the president and
CEO of MEIRxRS, a family of science,
technology, engineering and math
recruitment and staffing organizations in Glendale, CA. She has a
masters degree in communication
management from the University of Southern California in
Los Angeles. Christopher is an ASQ member and past chair
of the ASQ Food, Drug and Cosmetic Division.
PAUL DIONNE is a business developer
for MEIRxRS in Glendale, CA. He holds
an MBA from Boston University in
Massachusetts.
handling its current situation, and how

its going about it.
videos.asq.org/asq-standards-channel
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15-03-09 1:49 PM
STATISTICS ROUNDTABLE
BY CONNIE M. BORROR
Blocking Benefits
Including nuisance factors during experimentation
WHEN CONDUCTING even a seemingly
millimeters. Thirty flakes were toasted,
in a designed experiment when it should
simple experimentsuch as one with
measured at five locations, and the aver-
be included, you could obtain erroneous
a single factor with several levelssig-
age of all 150 thicknesses was used as the
conclusions about the factor of interest. In
nificant care and consideration should
response. The factor of interest is toast-
addition, if the blocking factor was used
go into the design setup. It is rare for
ing time, and four times are considered
in the experiment, but the wrong analy-
the response of interest to be influenced
(in seconds): 20, 40, 60 and 80.
sis carried out, you also could reach the
only by one factor under study during the

actual experimentation.
There could be a number of other
Three replicates for each toasting

time were obtained while randomizing
wrong conclusion about the factor of interest. Lets look at the latter a little closer.
the times. You want to know whether
factors affecting the response if not
toasting time has a significant effect on
ANOVA activities
controlled or included in the experi-
flake thickness. In other words, is there a
Given the designed experiment discussed
ment. Those factors that are not the main
statistically significant difference among
earlierwith four toasting times and
factors of interest but could influence
the toasting times?
three ovensa total of 12 average thick-
the response are often referred to as nui-
nesses were obtained, as shown in Table
sance factors. If the nuisance factor can
1. An analysis of variance (ANOVA) was
be controlled during experimentation, it
carried out for the experiment, and the
is often included in the design setup as a
results are listed in Table 2. In this experi-
blocking factor.
ment:
If there is only one nuisance factor
The factor of interest is toasting time.
with several levels, you try to carry out a
The goal is to determine whether there
randomized block designgiven the main
is a statistically significant difference
factor (factor of interest) can be random-
among the four times. A final goal may
ized within each level of the blocking
be to determine the optimal or best
factor. If there is more than one nuisance
toasting time.
factor, you may be able to include them in
The oven is a blocking factor because
the design setup as well as using designs,
you think different ovens may influ-
such as the Latin square design. In this
ence the results, but it is not a main
article, the importance of blocking using
factor of interest. That is, youre inter-
one main factor (with four levels) and
ested in picking the optimal oven. You
one nuisance factor (with three levels)
will not determine which oven gives
will be illustrated.
the best results and only use that oven

In this experiment, there were three
and discard the other two.
Corn flakes and ovens
ovens that could be used for toasting,
Suppose youre interested in the thick-
so toasting time could be randomized
which provides evidence there is a
ness of corn flakes after they have been
within each oven. Because ovens may
statistically significant difference among
toasted. Toasting is just one of the
operate differently and possibly affect the
the four toasting times. Toasting time
processing steps of corn flakes for cere-
flake thickness, ovens were treated as a
appears to have a significant effect on
als and can cause several changes in the
blocking factor in the experiment. There
the average corn flake thickness. Some
corn flakes, which in turn could affect the
were other possible nuisance factors at
statistical software packages will report a
consumers view of the cereal.
play, but they were held constant for the
p-value for the blocking factor as well. As
purpose of the experiment.
stated earlier, however, youre not always
Puffiness or thickness is one

response of interest and is measured in
If you dont include the blocking factor
The p-value for toasting time is 0.031,
interested in statistical significance of the
Average corn flake

thickness / TABLE 1
Oven
Time
Analysis of variance for

corn flake thickness / TABLE 2
Source of variation
DF
SS
MS
P-value
Toasting time
1.550
0.5167
6.02
0.031
1.145
0.5725
0.0858
20
1.6
0.6
0.7
Oven
40
1.7
1.6
0.8
Error
0.515
60
1.2
1.6
Total
11
3.210
80
0.7
0.3
DF = degrees of freedom
SS = sum of squares
MS = mean square
F = (found variation of the group averages)/(expected variation of the group averages)
blocking factor (although this may provide

you with some insight as to whether some
type of maintenance may be needed). As
suspected, they may have affected the
response, which is why the factor was in-
Analysis of variance for corn flake

thickness without ovens / TABLE 3
Source of variation
DF
SS
MS
P-value
Toasting time
1.550
0.5167
2.49
0.134
The correct analysis
Error
1.660
0.2075
Now, carefully consider the importance
Total
11
3.210
cluded in the experiment in the first place.
of blocking and using the correct analysis. Suppose the experiment is run in the
exact same manner (with ovens as blocks
and toasting time randomized within the
DF = degrees of freedom
SS = sum of squares
MS = mean square
F = (found variation of the group averages)/(expected variation of the group averages)
block), but the results are incorrectly

I like to think of the error as a trash
experiment involved ovens, which was the
ovens. Table 3 provides the ANOVA for
can: Its where all quantities go that can-
appropriate design, but the wrong analysis
this situation.
not be assigned to some other factor or
carried out.
analyzed without the blocking factor:
Now, notice that toasting time is not
interactions involved in the experiment.
Any time you can include a blocking
statistically significant with a p-value
Id prefer the error not be large, but that
factor or other factors in the experiment
of 0.134. That is, toasting time does not
it could be parsed into df and SS for other
itself, you should. The next step is to
significantly affect flake thickness. What
factors. That is, when you can identify a
make sure to carry out the experiment as
happened? The degrees of freedom (df),
source of variation, the df and SS can be
planned, and if any deviation is encoun-
sums of squares (SS) and mean square
partitioned into that source (or sources if
tered, it should be recorded and reported.
(MS) for toasting time are identical to the
more than one), and you have a better idea
The type of analysis depends on the actual
previous analysis, but the F value and, of
of what role factors play in an experiment.
experiment conducted. QP
course, p-value differ. These values are not
Because in this case, the error mean
influenced by the addition or omission of
square increased, the overall F value for
other factors (such as ovens).
toasting time decreased (and resulting
The error has changed, however, and
p-value increased)giving the wrong
it is the mean square for error that is used
result that toasting time is not statistically
to obtain the F-value and thus, p-value for
significant. This is the wrong conclusion
toasting time. The error quantities now
because you know the origin of some
include all of the values once represented
of the error quantities: the ovens, which
by ovens. The df and SS for ovens dont
for some reason did not get included in
just disappear, but get lumped in with the
the analysis (I have seen this happen in
remaining error.
practice on more than one occasion). The

REFERENCE
1. B. Sumithra and Sila Bhattacharya, Toasting of Corn
Flakes: Product Characteristics as a Function of Processing
Conditions, Journal of Food Engineering, Vol. 88, No. 3,
October 2008, pp. 419-428.
CONNIE M. BORROR is a professor

in the school of mathematical and
natural sciences at Arizona State University West in Glendale. She earned
her doctorate in industrial engineering
from Arizona State University in
Phoenix. Borror is a fellow of both
ASQ and the American Statistical
Association and past editor of Quality Engineering.
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2015 INTERNATIONAL CONFERENCE

ON QUALITY STANDARDS
November 9 10, 2015 | Indianapolis, IN
BE A PART OF THE NEWEST

ASQ CONFERENCE!
It is vital to ensure products and services meet customer needs, and
there is no better way to guarantee customer satisfaction than with
quality standards and the guidance provided in management systems.
This new conference from ASQ, the global voice and leader in the
quality community, gives your company the opportunity to showcase
your resources to an invested audience of people passionate about
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There are several opportunities available, allowing you to maximize
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QPTOOLBOX
Digital amplifier
any type and size.
Mahr Federals digital IC amplifier, the
Flange Armour pro-
Millimar C1200, allows users to view the
tects flange faces
analog scale and numeric digital readings.
during
Its display range is 5000 m and reading
site delivery, instal-
resolution 0.1 m.
lation and storage.
The C1200 is powered by rechargeable
fabrication,
One of the main
batteries or an external power supply.
root causes for flange
When battery operated, the compact unit
damage is the use of
is fully portable.
hand tools during the
Operating features are set up using an
fabrication and com-
integrated five-button keypad. Features
missioning stages of
such as unit selection, normal/reverse po-
the product. Flange
larity, measuring range, preset, factor and
Armour
tolerance entry are easily set up by visual
flange face defects
menu options. When tolerances are used
and
the display shows a pass/fail status using
improves production
a green/red color on the backlit display.
performance. Flange Armour also reduces
Call: 800-343-2050.
the need for flange re-facing.
ergy to vibratory energy. The waveguides
Visit: www.mahr.com.
Call: 844-693-1073.
are designed to resonate at the frequen-
Visit: www.flangearmour.com.
cy of operation of the power supply and
damage
and
Flange protection
prevents
Flange Armour provides full flange and
Tube drawing system
raised-face protection for industries in-
Sonobond Ultrasonics has re-
volved with the production of flanges of
leased a tube drawing system
The transducer converts electrical en-
transducer.
designed to
accommodate
manufacturers
of fine metal
tubing used in
syringe needles. It is also
for medical devices and
used to produce: implantable device
tubing products used in
components; in vitro diagnostic probes;
industries that transport
bands for catheters and guidewires;
critical fluids.
heat-exchanger tubes for controlling
In an ultrasonic system,
Ultrasonically drawn fine tubing is
blood temperature during surgery; micro-
a power supply converts
surgical tools; stents; and other devices
line power to high-voltage,
requiring tubing with a fine internal
high-frequency electrical
dimension finish.
power needed to drive the
Call: 800-323-1269.
transducer.
Visit: www.sonbondultrasonics.com.
Transmitter
Videoscope
The Model 4020LT-A two-wire transmitter
Olympus has introduced the Series
from Cosasco provides enhanced resolu-
C industrial videoscope designed for
tion measurements of metal loss due to
inspections of manufactured parts,
corrosion inside pipelines. The transmit-
structures or areas that have limited
ter is designed for operation in plant
direct visual access. The Series C
locations with widely separated monitor-
videoscope features advanced ar-
ing points and a preexisting distributed
ticulation and high-resolution image
control system.
quality. It captures still images and
The Model 4020LT-A features mea-
videos with desired brightness.
surement resolution to 0.1%, allowing a
The videoscopes flexible distal tip
timely response to corrosion rate spikes.
and a proprietary spring neck design
The transmitter has an available NEMA
reduces stress when navigated
4x-rated stainless steel enclosure for op-
through tight bends or sharply curved
series is RoHS compliant and the high-
eration in harsh environments. A switch-
spaces. Articulation is made possible by
peak pulsed laser diode modules operate
able probe-type selector allows users to
the thumb-driven joystick on the unit
typically at a center wavelength.
adjust between different Corrosometer
that controls 360 articulation of the
The SCW 1430 product series are
electrical resistance probe types.
distal tip and up to 120 angulation.
intended for optical testing applications
Call: 800-635-6898.
Visit: www.cosasco.com.
A protective replaceable cap added

to the distal end tip of the insertion tube
where high-peak pulsed optical power

is required. The higher power offers
protects the LED light source
greater dynamic range capability to OTDR
and the video camera when
manufacturers.
used in harsh environments. The
Call: 732-516-6520.
Series C videoscope is suit-
Visit: www.laserdiode.com.
able for routine and specialized

inspections.
Call: 781-419-3562.
Visit: www.olympus-ims.com.
Laser diode modules
OSI Systems SCW 1430 laser

diode module series is specifically designed for optical test
applications such as optical
time-domain reflectometers
(OTDR) and optical spectrum
analyzers.
The SCW 1430 product series
features pulse drift performance
and high stability. The modules
come in four package types. The
GOT A QUALITY PRODUCT?

Send your product description and
photo to vellifson@asq.org.
QPREVIEWS
The Certified Quality
Improvement Associate
Handbook: Basic Quality
Principles and Practices
most commonly used quality tools.
dedicated to customer-supplier relation-
the analysis and math, the author guides
Russell T. Westcott and Grace L. Duffy, ASQ
ships. There is also a nice discussion
the reader from basic systems up to large,
Quality Press, 2014, 288 pp., $69 member,
about the process of supply chains, which
complex and multistate systems and uses
$105 list (third edition, book).
includes key supply chain metrics. The
a consistent set of examples based on an
This book serves
last unit on system integration discusses
iterative approach.
as a valuable
the view of the organization as a system
source of informa-
and distinguishes the process view from
large hierarchal systems, and there is a
tion pertaining to
the systems view. It emphasizes taking a
chapter on process modeling. In discuss-
quality concepts,
systems view of quality improvement.
ing large, complex systems, the author
quality improve-
We live in an era of outsourcing and

offshoring. Recognizing this, there is a unit
This book is written in simple and
system breakdowns and variations of system arrangements and performance.

Easy to read but challenging in terms of
Other systems are discussed, such as
uses the asymptotic approach along with
ment and continu-
easy-to-understand language such that
ous improvement.
readers with little or no knowledge of
The information
quality concepts can understand and apply
of mathematics and research built around
is presented in
quality tools with confidence. This book will
a logical but comprehensive bibliogra-
five units, each dedicated to an important
serve as a valuable reference for everyone
phy. Elsevier specializes in technical and
aspect of quality improvement. The book
involved in the quality engineering and
leading-edge books, and this is representa-
begins with detailed explanations of the
quality management industry.
tive of that high standard. Please note that
key concepts and definitions pertaining to
Rangarajan Parthasarathy
quality, and then discusses the benefits of
Harvard, IL
quality improvement and employee involvement in quality improvement efforts.

There is a chapter dedicated to the phi-
several examples.
The book is a highly detailed assemblage
while this is a truly challenging topic it is

also logical, highly polished and thoroughly
researched.
Reliability of Large and

Complex Systems
losophies of the quality gurus. This chapter
Krzysztof Kolowrocki, Elsevier Insights,
contains valuable information regarding
2014, 460 pp., $200 (second edition, book).
Frank Pokrop
San Diego
the way the quality leaders viewed quality
The book assumes
and continuous improvement, and it also
readers are famil-
presents their contributions to the quality
iar with a number
How to Succeed With

Continuous Improvement:
A Primer for Becoming the
Best in the World
movement.
of underlying prin-
Joakim Ahlstrm, McGraw-Hill Education,
ciples of concepts
2014, 128 pp., $25 (book).
is the key to the success of any quality
Recognizing that employee involvement
such as reliability,
Big efforts often fail because no one feels
improvement project, the books second
calculus and how
responsible for major changes. Thats why
unit has two chapters dedicated to under-
to devise formulas
the most successful companies focus on
standing how employees work in teams,
that represent
improving the small things, which together
and the key issues involved in team forma-
multifaceted
add up to major paybacks. While this book
tion and group dynamics. The third unit is
mechanical and
is comprehensive and easy to read, it does
devoted to the tools and techniques used
electrical systems. It is clearly aimed at the
in continuous improvement and process
more experienced reader and dives into
improvement projects. There are elaborate
the world of complex systems, higher-level
ous improvement. The method of problem
explanations with suitable examples for the
math, and a continuous series of analysis,
solving and achieving improvement is not
not focus on a specific industry or sector.

Simply solving a problem is continu-
important. This book discusses the FISHY

method for problem solving and provides
limitations and breaking points.
ples from the authors extensive work and
The book is broken into four sections
research to demonstrate application. The
many examples. The FISHY method entails:
building from an understanding of risk;
book also includes exercises and questions
1. Formulate the question.
to simple Monte Carlo simulations in MS
making it an excellent resource in an edu-
2. Individual work.
Excel; to applica-
cational environment. A glossary of terms,
3. Spread out the notes.
tions in fixed income
an index and reference material make this
4. Have consensus through voting.
and commodities; to
a good starting point for self-education.
5. Your to-do list is introduced.
a review of the prod-
The focus of this book is the corporate
The book includes success factors for
uct universe driving
risk-management professional. However,
improvement work and practical advice on
risk. The risk section
any person interested in using models to
how to start and
focuses on com-
better understand and manage riskpar-
maintain momen-
plexity of analysis
ticularly in the financial arenawill find this
tum. It features
versus complexity of
book interesting.
a questionnaire
models, dealing with
for determining
volatility, target accounts for managing risk
the current state
along with risk policy and risk regulation.
of a problem, a
The Monte Carlo simulation section de-
Bryan Ruggles
Everett, WA
RECENT RELEASES
reference guide
velops simplified MS Excel pricing models
for completing
and takes a layered approach to evaluate
fishbone diagrams
the effect of changes in prices on business
in 15 minutes and
and performance metrics. The fixed income
Configuration Management
For Senior Managers
and commodities section includes applica-
Frank B. Watts, Butterworth Heinemann,
tion examples that focus on identification
2015, 180 pp., $100 (book).
an additional reading list.

When you do not take time to make
improvement, you do not get better. Every
of relationships, drivers and data across
business will gain from following the
commodity markets. Finally, the last section
authors well-considered methods and
provides a broad review of the product
Quality Management in a Lean

Health Care Environment
recommendations.
universe, pricing and valuation models.
Daniel Collins and Melissa Mannon,
Marc A. Feldman
Houston
Models at Work: A
Practitioners Guide to
Risk Management
Jawwad Farid, Palgrave Macmillan, 2014,
656 pp., $75 (book).
If anything has been learned from history,
the importance of understanding how to
evaluate and model risk in the financial
markets is more important than ever. The
author takes a practitioners approach to
The book is well-written and follows a

logical progression. There are many exam-
Business Expert Press, 2015, 120 pp.,

$59.95 (book).
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RESEARCH
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By participating in the Global State of Quality 2 Research survey,
you will help lead to a better understanding of quality strengths
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TRAINING
CERTIFICATION
CONFERENCES
MEMBERSHIP
PUBLICATIONS
TM
ONE GOOD IDEA
BY UMESH KRISHNAPPA
See the Full Spectrum

Monitoring the effectiveness of corrective actions
TO ELIMINATE FAULTS from reap-
equacy are highly repetitive in nature (see
pearing, fault data spectrum (FDS) is a
Online Figure 1, found on this columns
The FDS grid (see Table 1) contains
tool that can monitor the effectiveness
webpage at www.qualityprogress.com).
fault codes and product serial numbers
Faults are not created equal. The im-
of corrective actions (CA) on a continu-
and a positrol grid.
or production batch numbers. In each
ous basis. An FDS visually displays the
pact of a few could have catastrophic ef-
column, it color codes the implementa-
effectiveness of your CAs. If faults still
fects on the product, such as safety faults.
tion of CAs with reference to the affected
occur after CAs are implemented, your
Other types may occur in large numbers
product serial numbers. After the imple-
organization will catch them early enough
and not be noticed by customers and only
mentation of CAs, the faults should taper
to regroup the CA teams for additional
by highly critical inspectors. These faults
off drastically or disappear.
plan-do-check-act (PDCA) cycles, to
dont have any affect on functionality or
conduct proper root cause analyses and to
reliability and could be resolved through
was taken after product 226, but the ac-
create fully effective CAs.
simple changes to a process or material.
tion was only partially effective and didnt
This is why faults need classifications.
A fault can occur in a process or
For faults F1 and F2, for example, a CA
completely eliminate complaints. After
product component if its parameters
Acceptance quality levels (AQL) can be
another PDCA cycle occurred at product
deviate beyond the permissible limits of
decided for different categories of faults
326, the faults didnt recur in 2,700 prod-
its designed intent. A process fault could
based on the criticality of the product.
ucts sold.
happen due to high dispersion and can be
Critical healthcare equipment, for ex-
controlled by the process and machine
ample, will have a rigid AQL.

Faults are classified, coded and later
parameters. Process faults ultimately lead

to faulty products.
A fault also may result if the desired
output is not achieved with the intended
tureda costly lapse for the organization.
and the fault codes are created during
Faults three, four, five, seven and eight
development stages.
showed CAs that were done right the first
FDS of a subsystem with fault

codes and factual data for up to
3,000 units sold / TABLE 1
80
Fault data spectrum for XXXX assembly

13
5
6
3
41
4763,000
401475
376400
351375
326350
301325
276300
251275
226250
201225
176200
151175
126150
101125
76100
5175
2650
025
Production
batch
Total
Fault
types
1
1
1
1
1
6
4
7
2
13
1
3
1
1
2
2
1
1
1
1
2
1
1
2
2
1
1
1
1
1
2
xxxx not
opening
with zzzz
Final
effective
solution
xx/yy not
opening
from
inside
xx/yy not
opening
from
outside
Interim action
not fully effective
xxxx noise
(abcd
loose)
nnnn
failures
a positrol sheet shown in Online Table 2.
short and effec-
For additional examples of FDS and posi-
tive. If it isnt, it
trol grids that were used on a manufactur-
will require anoth-
ing process for a hair dryer with five major
er cycle and cause
faults, see Online Tables 3 and 4.

FDS and fault classification are linked
cause of customer
and able to take actions upstream at tier
dissatisfaction
one, two and three supplier levels. They
is repeated inef-
can be used during development phases,
fective CAs (see
and each failure thats encountered in
Online Figure 2).
alpha, beta or pilot production is made
FDS is a tool
consisting of fault
visible for an easier and more effective

resolution. QP
classifications
with a positive
F1Fault 1 F2Fault 2 F3Fault 3 F4Fault 4 F5Fault 5 F6Fault 6 F7Fault 7 F8Fault 8

xxxx not
opening
with yyyy
time, and the actions were described in
cycle should be
delays. A main
3
1
1
was equivalent to 100 products manufac-
traced in the field (see Online Table 1),
A PDCA cycle is used for CAs, and the
design input. Faults due to design inad-
The additional PDCA cycle did,

however, consume production time that
xxxx
switch
failure
Containment action
White dot
mark
control plan (also

called a positrol)
in a grid structure. The tool
UMESH KRISHNAPPA is a director at

Quality Manufacturing and Design
Solutions Technology Pvt. Ltd. in
Bangalore, India. He holds an MBA
from the Symbiosis Center for
Distance Learning in Pune, India.
uses an FDS grid
FDS = fault data spectrum
BACK TO BASICS
BY RICK TOWNSLEY
Just Do It
Quality organizations dont always need certifications
SOME ORGANIZATIONS with certifi-
How do these organizations become
Service with a cookie
cations from the International Organiza-
so successful? They listen, respond,
Ive gone to the local eye institute for
tion for Standardization (ISO) do not
improve and start over again. They
several years. When I step inside, friendly
deliver high-quality products, and yet,
stay current with customers needs and
people are ready to help me at the front
organizations without these certifica-
expectations, study their competition
desk. The atmosphere is pleasant, and
tions sometimes provide amazing levels
and replicate best practices, and adapt to
there are color-coordinated walls, carpet-
of quality. Why is that?
changing conditions. In other words: they
ing and seating arrangements showing me
use the plan-do-check-act (PDCA) cycle.
where to find my doctor.
The goal of any organization is to

provide excellent quality products and
Whether the PDCA cycle is known to
The service is fast, and everyone has
services to its customers to earn their
an organization or not, its often intui-
a clearly defined job. Free coffee and
loyalty and repeat business. Its tradi-
tively implemented by smart, enterprising
tea are available at strategically located
tionally understood that organizations
people who know how to succeed without
stations, and theres even a staff member
possessing ISO certifications are the
all the charts, graphs and documented
who walks around with a tray of warm
best of the best. Sadly, this isnt always
management reviews. Instead of getting
cookies. Have a cookie please, she
the case, and sometimes even the op-
caught up on collecting paper (known as
says. Theyre delicious.
posite is true.
objective evidence to quality auditors),
Another staffer engages and consoles
they just do it. There are two real-world
some of the older patients. For patients
the importance of these certifications,
examples I frequently encounter that
who need assistance, a courtesy van
but you also should consider that some
illustrate organizations just doing it, not
waits outside to take them home.
organizations dont subscribe to these
overdoing it.
It would be a mistake to discount
standards, and their customers ratings
Great customer service is just one

piece of the quality puzzle, but many
show theyre superior to their certified
Consistent satisfaction
elements of the ISO 9001 standard are
counterparts. This is because they un-
When I visit Mikes Deli near my office,
represented in these examples, such as:
derstand what it takes to be successful
theres usually a line of customers in front
execution to management responsibility,
without all of the policies, procedures,
of the building before it opens. When the
customer focus, planning, provision of
work instructions and reams of docu-
doors open, people flock inside.
resources, infrastructure, consideration
mentation.
One person takes your order and

gives you a number, and another
person works the cash register.
of work environment, product realization and data analysis.

Dont get caught up on quality certi-
You get a beverage at the drink
fications alone, and look deeper into an
station and sit down while your
organization as a whole. Everyone can
food is prepared. Within minutes,
learn from everybody whether they hold
your number is called, and youre
certificationsor not. QP
eating.
Regardless of how busy it is,
the service is consistently great,
the food is fresh and prepared
exactly how you requested, and
youre out the door in 20 minutes.
As you leave, the owner greets you
and thanks you for your business.
RICK TOWNSLEY is a quality management systems advisor at Resource

International in Redington Shores, FL.
He holds a doctorate in business administration from Kennedy-Western
University in Cheyenne, WY. A senior
ASQ member, Townsley is an ASQcertified quality auditor, engineer and
manager of quality/organizational excellence.
ISO/FDIS 9000:2015 and

ISO/FDIS 9001:2015
The revised ISO 9001 standard will be published in fall 2015. But, dont wait to get a jumpstart on your training, auditing, and more to become certified to the new standard!
The ISO/FDIS 9000:2015 and ISO/FDIS 9001:2015 are now available for purchase!
To get started, and to learn more, visit asq.org/aboutstandards.
Remember to always stay connected to ASQ through the 3 Cs of standards.
asq.org/standardsconnection
TRAINING
CERTIFICATION
/videos.asq.org/asqstandards-channel
CONFERENCES
asq.org/standards
MEMBERSHIP
PUBLICATIONS
TM
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QUALITY PROGRESS | SEPTEMBER 2015

Putting Best Practices to Work

www.qualityprogress.com | September 2015

Learn the statistics you need to make

e-learning for statistics

October 27-29, 2015

Find Quality Answers and

The Quality Show Highlights:

Register for FREE today at QualityShow.com

Keep Calm and Prepare for ISO 9001:2015

A Hard Look at Software Quality

by Moiss Rodrguez, Mario Piattini and Carlos Manuel Fernndez

Like Father, Like Son

A look back at the lasting contributions Ichiro Ishikawa and

by Lance B. Coleman Sr.

by Bill Aston, Susan L.K. Briggs, Charles A. Cianfrani, Deann Desai,

Small Business Challenge

A sidebar for this months

More figures to illustrate how

Stay in the Loop

Subscribe to the new Standards

Translated into Spanish.

Rate and comment on this months

Tips on initial ISO 9001

Dealing with drones.

Mr. Pareto Head

Follow protocol of first initial and full last

Measure for Measure

Updates needed to the occupation

Quality in the First Person

In job searches, do your homework

To learn more about the manuscript review

One Good Idea

Including nuisance factors during

Are standard certifications always

Authorization to photocopy items for

- STRUCTURED DECISION MAKING

How one energy company uses an automotive

ASQs Vision: By making quality a global priority, an organizational imperative and

Article photocopies are available from ASQ

Membership and Subscriptions

For nearly 70 years, ASQ has been the

Orders for ASQs member and nonmember

EXECUTIVE EDITOR AND

Handy primer on the ISO 9001 revision

This months Expert Answers department, p. 8, addresses some other important

DIGITAL PRODUCTION SPECIALISTS

MEDIA SALES ADMINISTRATOR

gerous circumstances in the skies. In July, for instance, forest-firefighting aircraft in

To promote discussion of issues in the field of quality and

next year when an auditor finds that one

In response to Back to Basics: Sufficient

clause everyone else overlooked.

Evidence (August 2015, p. 64): In my ca-

reer as a computer components software

Putting Best Practices to Work

QUALITY PROGRESS | AUGUST 2015

quality engineer, I developed

CREATIVITY SPARKS INNOVATION

a profile of the prospective

Person: Substandard Training

strengthen its weaknesses.

The Global Voice of Quality

(July 2015, pp. 46-47): Very good