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JAN UARY 2018 | QUALIT YPROG RE SS .

COM

The State of Dissecting Eliminate


Management Innovation The Evils
System Strategy Of Inventory
d
Standards
page 32 page 46 page 64
|JANUARY 2018

The official publication of ASQ

THE
Time
IS
Now
ISO 9001:2015

With the deadline fast


approaching, how
ready are you for the
ISO 9001 transition?
VOLUME 51 | NUMBER 1

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FEATURES
16 Ready or Not 24 Under the Wire 32 No Joking Matter 38 For Best Results
The basics behind ISO Knowing the seven A recent study centered Combine quality function
9001:2015 and advice quality management on management deployment and design
for organizations principles that ISO systems standards thinking to make the
transitioning to the 9001:2015 is built raises questions on most of the product
revised standard. around will help the overall average development process.
your organization effect of standards
by Govind Ramu implement or on organizational by Patrícia Moura e Sá
transition to the performance.
revised standard.
by Pavel Castka and
by Mark Durivage Charles J. Corbett

INSIDE
January 2018
VOLUME 51 ● NUMBER 1 EXCLUSIVES
at qualityprogress.com

For Next Time


Retain QP content to read and
reference later in the “My Saved
Articles” repository.

Read and Write


Provide feedback to authors and
editors, and rate this month’s four
feature articles.

Back to Basics
The column translated into Spanish.

qualityprogress.com ❘ January 2018 QP 3


INSIDE
January 2018

8 10 14 51

6 Seen and Heard 14 Career Coach 58 Marketplace


Analyzing the risk around everyone’s
bottom line.
8 Expert Answers 60 Footnotes
The differences between
DFSS and DMADV. 46 Innovation Imperative
The structure and thinking behind 64 Back to Basics
the innovation management How much inventory is too much?
10 Progress Report standard.
Big changes that are reshaping
the manufacturing industry.
PLUS 51 Statistics Spotlight 64
Getting to Know … Reconciling process capability and
Rajeev Chadha performance with specifications.

12 Mr. Pareto Head


54 Standard Issues
Two troublesome IATF 16949
requirements.

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4 QP January 2018 ❘ qualityprogress.com


FOREWORD
The quality inside Quality Progress

Tick Tock Time is running out to get ISO 9001:2015 certified

Just nine months remain until the deadline to certify to the certification, the importance of finding the right registrar and
ISO 9001:2015 quality management standard, and much like consultant, and other tips for successful implementation.
the months leading up to the birth of a baby, it is a time rife Many are racing to the finish line with ISO 9001, but after
with worry, confusion, research, planning and probably some the dust clears, you may want to spend some time thinking
notable discomfort. After the certification deadline arrives in about “Why?” Are standards really a driving force in quality
mid-September, ISO 9001:2008 certificates will no longer be improvement? “No Joking Matter,” p. 32, details the results of
valid, and life begins anew. a study on management systems standards and their overall
In advance of the standard’s release, and leading up to impact on organizations’ performance.
today, QP has worked to provide information and resources to Finally, I mentioned ASQ’s many resources to help you
help ease the transition. This month, we help you with a final through your ISO 9001 transition journey. We made it easy
check on where you are in the process, and we provide you a for you to access them by listing them all in one place. Turn to
summary of the many valuable resources you can find avail- “The Clock Is Ticking,” pp. 22-23.
able from ASQ: online, in video and in print, and in person.
Perhaps you are well on your way or already certified to the
standard. If so, congratulations! For those who still have work
to do, read “Ready or Not,” p. 16. Author Govind Ramu’s mes-
sage is clear: Don’t delay another minute. Many certification
bodies won’t conduct transition audits after May, so the time
is now to get one scheduled so there is time to complete any
post-audit work.
“Under the Wire,” p. 24, details the seven quality man-
agement principles ISO 9001:2015 is built around and Seiche Sanders
also provides some useful tips on how to get prepared for Editor in Chief and Publisher

TCC Heather Crawford, Apollo Endosurgery Administrative Committee


Secretary William J. Troy, ASQ Brady Boggs, Randy Brull, Jane Campanizzi,
Larry Haugh, Jim Jaquess, Gary MacLean,
Directors R. Dan Reid, Richard Stump
Donald Brecken Ferris State University
Jim Creiman Northrop Grumman Corp. Technical Reviewers
Ha C. Dao Emerson Climate Technologies Naveen Agarwal, Ashraf Ali, Suresh Anaganti,
David Levy Boyce Technologies M. Onur Artan, Andy Barnett, Matthew
ASQ’s Vision Barsalou, David Bonyuet, David Burger,
Austin S. Lin Google
By making quality a global priority, an Brooks Carder, Bernie Carpenter, L.N. Prabhu
Raul Molteni Molteni Consulting
organizational imperative and a personal ethic, Chandrasekaran, Ken Cogan, Linda Cubalchini-
Luis G. Morales Daimler Trucks North America Travis, Ahmad Elshennawy, Mark Gavoor,
the American Society for Quality becomes the
community for everyone who seeks quality Mark Moyer CAMLS Kunita Gear, Daniel Gold, T. Gourishankar,
technology, concepts or tools to improve Daniella A. Picciotti Veridiam Roberto Guzman, Ellen Hardy, Lynne Hare,
themselves and their world. Barrie Simpson Genentech Access Solutions Victoria Jones, Trevor Jordan, Ray Klotz, T.M.
JoAnn Sternke Pewaukee School District Kubiak, William LaFollette, Scott Laman, Pradip
ASQ Administration Sunil Thawani Quality Indeed Consulting Mehta, N.S. Narahari, Arind Parthasarathy,
CEO William J. Troy John Vandenbemden Q-Met-Tech Larry Picciano, Gene Placzkowski, Tony
Polito, Peter Pylipow, Imran Ahmad Rana,
Senior Leadership Allen Wong Abbott
John Richards, James Rooney, Ayman Sakr,
Andrew Baines Lindsey Linder
Administration Manboubeh Samghabadi, Brian Scullin,
Kalleen Bruch Brian Savoie Abhijit Sengupta, Amitava Sengupta, Mohit
William J. Troy, CEO
Ann Jordan Jim Templin Seiche Sanders, Publisher Sharma, A.V. Srinivas, Adrian Tan, Joe Tunner,
Lynelle Korte B. Vaithiyanathan, Manu Vora, Keith Wagoner,
QP Editorial Review Board Jack Westfall, Doron Zilbershtein
Chair Eric Hayler, BMW Manufacturing Randy Brull, Chair
Chair-Elect Elmer Corbin, IBM
To promote discussion of issues in the field of quality and ensure coverage of all responsible points of view, Quality
Past Chair Patricia La Londe (retired – CareFusion) Progress publishes articles representing conflicting and minority views. Opinions expressed are those of the
Treasurer Francisco “Paco” Lopez, Metalsa 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.
SAC Sylvester (Bud) Newton, Jr., Alcoa

qualityprogress.com ❘ January 2018 QP 5


SEEN&HEARD
Reader reactions from around the world

MUST READ
I really enjoyed the November
issue of QP. The history is quite
es”
m o ri
S
EM ORIE e noble. While W. Edwards Deming
HE M er M
N KS F
OR T
t o “ R e a d 4 - 4 5) : submitted only one paper, he definitely
TH A se .3
spon r 2017, pp ection.
supported the publication. I wrote a monograph
I n r e e s for him on psychology, and he told me to put it
emb t his
(Nov s, QP, for tories. , Doha, Qat
ar in Quality Progress piece by piece. My QP article,
k s
Th a n a m a z i n g u m a r S h a rm
a “Theory and Practice of Employee Recogni-
l y A r vi n d K tion” (December 1992), currently is read more
Re a l frequently than any other article I have authored.
Thanks for the good work!
Brooks Carder, Del Mar, CA

THE REACTION GAUGE


this month's question Japan’s reputation for quality has taken a hit in recent
months. In October, it was discovered that Kobe
ê

As manufacturing processes become Steel Ltd., a major Japanese steel manufacturer, has
been falsifying its quality data since at least 2007.
more automated through new
The scandal affects about 500 companies, including
technologies such as 3-D printing,
last month's question ê Boeing, General Motors and Ford.
artificial intelligence and robotics, Nissan and Subaru also have been in the spotlight
employees must learn new skills to recently for flawed vehicle inspections. For decades,
keep up with the changes. both automakers used unauthorized employees to
What automated technologies has conduct final safety checks at their Japanese factories.
your organization adopted? How What can these organizations do to recover from these
have they changed your role? What is serious scandals? What can other organizations do to
prevent something like this from happening to them?
your opinion of the changes?
Ethan Jerry Mings, Oakville, Ontario: Peter Verhoeff, Tilburg, Netherlands:
One approach is to better understand how What can organizations do to recover?
ethics are used in daily decision making Take the blame, be honest and open
throughout the organization. Often, ethics up in light of initiatives to improve their
Send us your take at editor@asq.org. and values are crafted, posted and forgot- way of working. What can they do to
ten. Instead, the decision-making checklist prevent serious scandals? Create a cul-
should incorporate an ethics element to ture of trust and openness, and ensure
ensure all decisions are sound. Decisions mechanisms are available to report any
without an ethics check that can be veri- misconduct.
fied through an audit can leave individuals,
teams and organizations exposed. David Knowlton, Jefferson, MA, says:
Change will happen when the bottom
Anish Shah, Minneapolis-St. Paul, writes: line continues to go down, not up. The
Perform root cause analysis and follow organization’s management will have
plan-do-check-act to possibly recover at to provide evidence of conformance to
a faster pace rather than be consumed their customers and potentially change
by the sudden downfall due to a bad their culture.
reputation.

6 QP January 2018 ❘ qualityprogress.com


CHECK OUT THE NEW
BOOKS AVAILABLE FROM
ASQ QUALITY PRESS!
THIS MONTH’S PICKS!
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Management Using TRIZ Minitab, Fifth Edition
TRIZ is the Russian acronym This guide explains Lean
for theory of inventive problem Six Sigma in practical format,
solving. This book specifically and provides detailed Minitab
focuses on helping non-engineering instructions and screenshots
and management professionals throughout. Now in its fifth
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Learn more about these books through the


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Subject matter experts take on your quality-related queries

THIS MONTH'S FIRST QUESTION

My organization received
250 assembled electronics
components. Out of 125 sold
so far, two are defective.
How many of the remaining
125 components would I
have to test to have some
confidence that no defects
remain? Would I use a
hypergeometric sampling
table or ASQ Z1.4?

OUR RESPONSE

When I am asked a statisti- Based on binomial the probability of drawing For example, if the AQL =
cal question like this, I try probability, an observed a face card changes as the 0.25, the minimum required
to understand the situation failure rate of 2/125 = 0.016 cards are dealt. This affects sample size is 50 and the
by asking several questions, and the assumption that the odds that a particular acceptance criteria are A=0,
such as: the units sold are similar to hand (such as a straight) R=1. So, if you sample 50
++ How expensive are the the remaining units, there is will be a winning hand. Card units and find no defects,
components? about an 87% chance that counters give themselves you can conclude, with
++ If the components are at least one more defec- away if they systematically about 90% confidence, that
relatively inexpensive, does tive unit is in the remaining increase their bets as the the population defect rate
it make sense to reject the inventory. Releasing the stack of cards diminishes. is less than or equal to the
remainder of the lot? remaining inventory without You certainly may use AQL.
++ What is the impact to testing is not a good option. the American National The AQL values in the
customers if they receive a Hypergeometric sampling Standards Institute (ANSI) ANSI/ASQ Z1.4 table are
defective assembly? is inappropriate in this situ- and ASQ quality control given in percentages, so
++ Is the testing ation. You have a relatively standard Z1.4 to make a 0.25 is 0.25%, or 2.5 defects
non-destructive? small population, but you more-informed decision. per thousand. The ANSI/
++ How expensive and time don’t know how many The normal inspection table ASQ standard does not
consuming is the screening defects are in the remaining is based on about 90% con- guarantee or “give con-
test? inventory. fidence that the population fidence that no defects
Because you already have Compare this to a classic defect rate is at or below remain.” 1 It can only show
identified two failures, the application of hypergeomet- the acceptance quality that the defect rate in the
likelihood is high that there ric sampling used by card limit (AQL) if the number of population is less than or
are additional defective counters at a casino. They defects found in the sample equal to the acceptance
assemblies in your remaining know how many face cards is less than or equal to the level, as specified by the
inventory. are in a full deck and that acceptance level. AQL.

8 QP January 2018 ❘ qualityprogress.com


You can calculate the prob- THIS MONTH'S SECOND QUESTION
ability of passing the sampling
plan outlined earlier on most Is design for Six Sigma (DFSS) considered
calculators using the formula the same thing as define, measure,
yn, where y is the probability of
finding a good unit and n is the
analyze, design, verify (DMADV)? If not,
number of trials. what are the differences?
The probability of finding
a good unit is one minus the
probability of finding a bad
unit, or 1 – 0.016 = 0.984. So,
OUR RESPONSE
the probability of passing the
sampling plan in this situation There are so many acronyms flying around in the
is 0.98450 = 0.446. You can improvement world that people sometimes lose track
try this sampling plan, but the of their hierarchy. Regarding the differentiation between
odds are not in your favor. DFSS and DMADV, think about it this way:
The only way to be certain DFSS is the method—it is the overarching construct that
that no defects remain is to test we refer to as Six Sigma. DMADV is the tool used to design
100%. This may be the most new products and processes.1
prudent approach, especially if Think about it like this:
the cost of testing is less than ++ DFSS is the tool box and DMADV is the tool.
the cost of releasing defective ++ DFSS is the goal and DMADV is the means to accom-
product. Consider the cost plish the goal.
of a warranty claim and the Hopefully, this explanation helps to shed some light on
effect on your organization’s the difference between DFSS and DMADV.
reputation. Could a customer
REFERENCE
be injured if the assembly fails? 1. Gary A. Gack and Kyle Robison, “Integrating Improvement
Now that you know you have Initiatives: Connecting Six Sigma for Software, CMMI, Personal
a quality issue, you also must Software Process (PSP), and Team Software Process (TSP),”
Software Quality Professional, Vol. 5, No. 4, 2003, pp. 5-13.
consider your exposure to
liability lawsuits. This response was written by Keith Wagoner, senior
If the cost of testing is low, process consultant improvement consultant, BlueLine
consider 100% testing. If the Associates, Cary, NC.
cost of testing is expensive or
if the test is destructive, you
might be better off dropping
the testing altogether and
reworking the assemblies with
new components.

REFERENCE
1. American National Standards
Institute (ANSI) and ASQ, ANSI/
ASQ Z1.4 Sampling Procedures
and Tables for Inspection by
Attributes (2008).

This response was written


by Andy Barnett, director of
quality systems, NSF Health
Sciences Pharma Biotech,
Kingwood, TX.

qualityprogress.com ❘ January 2018 QP 9


A digest of
trends, research
& late-breaking
news

M A N U FAC T U R I N G

The State of
Manufacturing
Big changes reshape the industry’s total real output. In 2009, the manufacturing
future skills requirements sector’s real output took a dive and was the lowest it had been
since 1997. Over the past three years, however, the real output
has been on the rise. In the third quarter of 2017, the industry’s
With the Great Recession in 2008, manufacturing took a big total real output had increased 17.7% since 2009, approaching
hit. Between 2008 and 2009, the U.S. manufacturing industry’s its all-time high of 19.9% at the end of 2007.⁴
total real output—the measurement of the value of the goods an
industry produces—dropped almost 21%. In the same timeframe, What about jobs in the future?
about 15% of manufacturing jobs were cut. While manufacturing activity, output and jobs trended
It’s been a long struggle over the past 10 years, but there's good upwards last year, there is still a concern about the long-term
news for quality professionals and the workforce of the future: future of manufacturing jobs in the United States. Recent
Manufacturing is making a comeback. years have seen a redefinition of the traditional manufacturing
job role due to automation. As processes become more pro-
2017 snapshot ductive, fewer workers are required to accomplish the same
In 2017, two major factors contributed to the manufacturing indus- amount of work.
try’s boost—a weaker U.S. dollar and a stronger U.S. economy. Things like robotics, 3-D printing and artificial intelligence
A weaker U.S. dollar makes it easier for companies to sell their have cut down considerably on the number of human work-
products abroad—products are cheaper, and cheaper products ers a manufacturer needs, and that has many people worried
mean more buyers. In 2017, the U.S. dollar was about 9% below the about the future of jobs.
most-traded currencies.¹ But according to “Jobs Lost, Jobs Gained: Workforce
On the other hand, the U.S. economy has the lowest unemploy- Transitions in a Time of Automation,” a December 2017 report
ment rate since 2009 at just 4.1% and has steadily added jobs over by business and economics research firm McKinsey Global
the past seven years.² A thriving economy and a steady rise in jobs Institute (MGI), all that worry might be unnecessary.
means people are more willing to spend their hard-earned money, “Today there is a growing concern about whether there
thus the demand for manufactured products increases domestically. will be enough jobs for workers, given potential automation.
Add these two factors together—a weaker dollar and a stronger History would suggest that such fears may be unfounded:
economy—and the result is more manufacturing jobs. Last year, Over time, labor markets adjust to changes in demand for
American factories added jobs faster than in the past three years. workers from technological disruptions, although at times with
As of December 2017, 138,000 manufacturing jobs were added in depressed real wages,” the report said.⁵
the United States, a sharp contrast to the 34,000 jobs lost in 2016 Regardless, automation will have a real impact on the job
and the meager 62,000 jobs added in 2015.³ market. The report goes on to say that about one-third of
Another good indicator of the recovery of manufacturing is employee activities in about 60% of occupations have the

10 QP January 2018 ❘ qualityprogress.com


GETTING TO KNOW…

Rajeev Chadha
current position education

Industrial technology advisor at Master’s degree in management


the National Research Council and systems from the Indian
(NRC) of the Government of Institute of Technology (IIT) in
potential for automation.⁶ Over the next 10 years, mil- Canada. Delhi.
lions of people will need to find new jobs or learn new
skills to keep up with the changes brought about by What was your mining and manufac- and Saskatchewan
automation. turing industries and sections and ASQ’s
introduction to am active with NRC’s Energy and Environ-
“It is important to note, however, that even when some quality? mining sector team. mental division and
tasks are automated, employment in those occupations Mining Interest group.
I also teach and
may not decline but rather workers may perform new The automotive Do you have a mentor students and
sector of Ontario young professionals.
tasks,” the MGI report said. “Automation will have a lesser introduced me to mentor who has
effect on jobs that involve managing people, applying quality in the real made a difference
sense. I read about
expertise and social interactions, where machines are quality and lean Six in your career? Any recent honors
unable to match human performance for now.”⁷ Sigma principles in or awards?
academics, but my ASQ’s global network
actions were not has provided me with
Skilled workers tangible. Working
with Siemens VDO
mentorship oppor- Elected to ASQ’s 2017
class of fellows.
tunities that make a
Perhaps the biggest threat to the manufacturing industry Automotive, I was difference.
isn’t automation, but the lack of skilled workers. In 2015, able to use my aca-
demic knowledge for
the Manufacturing Institute and Deloitte reported that industrial purposes. What was the last
the skills gap is widening significantly.⁸ According to that What’s the best movie you saw?
report, “Over the next decade, nearly 3.5 million manu- Is there a teacher career advice
facturing jobs likely need to be filled and the skills gap is you’ve received? Michael Moore’s
who influenced “Where to Invade
expected to result in 2 million of those jobs going unfilled.” you more than Next.”
The report attributes this gap to several factors, includ- Continuously invest in
others? Why? your own self-
ing baby boomers retiring; a lack of importance placed development to Personal:
on science, technology, engineering and mathematics Sushil Kumar of sustain robust
IIT Delhi taught us professional growth.
(STEM) skills; and the fact that younger generations view Married to Amita. We
some very pragmatic have two daughters:
the manufacturing industry in a negative light.⁹ system design tools Aditi and Kriti.
to solve complex
These last two factors—a lack of STEM skills and the problems. That led to Any previous
negative image of manufacturing—are making it difficult national recognition jobs you consider What are your
and a medal for me
for organizations to recruit younger workers to fill the early in my career. noteworthy? favorite ways to
gap left by retiring baby boomers. According to the Man- His influence on me relax?
is slightly more than My job as a continu-
ufacturing Institute/Deloitte report, when asked about other gurus. ous improvement/Six
their negative image of the industry, teenagers said they Watching documen-
Sigma lead at Mosaic taries and listening to
Co.’s potash business
thought of manufacturing jobs as dirty, dangerous and What notewor- unit/mines gave me Indian classical music.
dead-end jobs that require little skill or thinking.10 thy activities or tremendous exposure
achievements out- to the mining industry
But, as noted earlier, manufacturing work is dras- in North America and Quality quote:
tically changing. According to the Manufacturing side of ASQ do you allowed me to lead as
Institute/Deloitte report: participate in? a Master Black Belt. "Intangible invest-
ment in quality gives
“With smart manufacturing or Industry 4.0, manufac- tangible returns in
I write reviews and life.”
turers are moving toward a new level of interconnected help with publications Are you active in
and intelligent manufacturing system, which incorporates at the Association of ASQ?
the latest advances in sensors, robotics, big data, control- Professional Engineers
& Geoscientists. I also
lers, and machine learning. This allows every aspect of the I volunteer for
network within the ASQ’s Edmonton
plant to be constantly accessible, monitored, controlled,
continued on page 12 

qualityprogress.com ❘ January 2018 QP 11


ASQ SURVEY

The State of Manufacturing Manufacturers:


continued from page 11
designed, and adapted for real-time
adjustments.”11
Onward
So, what does all these mean for the
Finding Skilled
Because of these new technologies and
automation, manufacturing organizations
future of manufacturing? As mentioned,
manufacturing has been and continues to Workers No. 1
are moving away from the skill set needed
for manual labor in favor of technically
skilled employees.
grow. While the numbers aren’t drastic,
production is expected to increase 2.8%
this year, 2.6% in 2019 and 2% in 2020,14
Challenge for 2018
“The sophistication of today’s (and tomor- and technological advancements will push For the first time in five years, the
row’s) factories places greater onus on new the industry forward. shortage of skilled workers was
and existing workers to increase their skill As automation and new technologies cited as the No. 1 hurdle manufac-
set and to come to the table with the STEM advance, manufacturing processes and turers said they anticipate in the
skills necessary to operate in an advanced jobs will be redefined. While this might year ahead, according to ASQ’s
manufacturing facility,” the report said.12 mean some job loss, according to MGI, 2018 Manufacturing Outlook
As for the sometimes-negative image of labor markets will adapt. Survey.
Forty-one percent of manufac-
manufacturing, many manufacturers are And so will employees. Workers will per-
turers said finding skilled workers
working hard to overcome that negative form new tasks and learn new skills (such
will be their greatest challenge in
stereotype by bringing awareness to what as STEM skills) to adapt to the changing 2018, compared to 30% who said
the industry is really like. technology.15 And these new skills will bet- the economy will be their biggest
“More than 1,600 manufacturing events, ter prepare up-and-coming workers for the hurdle.
with an estimated 250,000 attendees, millions of manufacturing jobs that will be In last year’s survey, 36% of
were recently hosted as part of Manu- vacated by retiring baby boomers. manufacturers said the economy
facturing Day. The efforts’ mission is to Change is inevitable. The manufactur- would be the greatest challenge,
increase positive perception of the indus- ing industry will continue to change and compared to 30% who claimed
try and ensure ongoing prosperity of the evolve, and so must we. finding skilled workers would be
industry, something the industry sorely the biggest hurdle.
needs to attract the number and level —compiled by Lindsay Dal Porto,
of talent required,” 13 the Manufacturing assistant editor
For more on the survey,
Institute/Deloitte report said. visit https://tinyurl.com/
EDITOR’S NOTE asq-2018-out-survey.
References listed in this article can be found on the Progress Report webpage at qualityprogress.com.

Mr. Pareto Head By Mike Crossen

12 QP January 2018 ❘ qualityprogress.com


LEAN SIX SIGMA ASQ SURVEY

Lean Six Sigma FIVE ORGANIZATIONS NAMED


2017 BALDRIGE RECIPIENTS
Conference Five organizations were named recipients of the 2017 Malcolm

Planned Baldrige National Quality Award. Announced in early December, the


recipients are:
ASQ’s Lean and Six Sigma Conference will be 1. Bristol Tennessee Essential Services, Bristol, TN (small business
held Feb. 26-27 in Phoenix. sector).
The theme of the conference is “Sustaining a 2. Stellar Solutions, Palo Alto, CA (small business sector).
Culture of Excellence in a World of Disruption, 3. City of Fort Collins, Fort Collins, CO (nonprofit sector).
Innovation and Change.” 4. Castle Medical Center, Kailua, HI (healthcare sector).
For more information and updates on 5. Southcentral Foundation, Anchorage, AK (healthcare sector).
conference events, as well as announcements The 2017 awards will be presented at a ceremony during the Quest
about keynote speakers, visit https://asq.org/ for Excellence conference in April in Baltimore. For more background
conferences/six-sigma. on the recipients, visit https://tinyurl.com/2017-baldrige-recipients.

EDITOR’S NOTE: To mark the 50th anniversary of the debut of Quality Progress in January
1968, each month this year, editors will highlight a different element of the magazine
throughout its history. This month, we bring back a couple brief articles included in the
magazine’s news digest—originally titled “News You Might Need”—from January 1968.

Drink First—Park Later, Change will cost millions for these “The second is the duration of
companies—not to mention the cost of 9,192,631,770 periods of radiation cor-
Standardization Is Great
removing jammed rings from parking responding to the transition between the
meters once the new rings appear. two hyperfine levels of the fundamental
DETROIT—Elmer Ploof has problems In the meantime, Elmer Ploof is open state of the atom of cesium 133.”
by the bushel basket. He’s in charge of to suggestions. Two important advantages of the
parking meter collections here. Accord- atomic definition:
ing to the STANDARDS INSTITUTE It can be generated by a suitable
REPORTER, Elmer is not happy about Conference Adopts Atomic clock with sufficient precision (+/-1 part
overflowing bushel baskets of pull-rings Second as International in a hundred billion or better) to meet
from soft drink and beer cans sitting in Unit of Time the most exacting demands of current
the city treasury safe. metrology, and
Since people found rings do nicely at PARIS—The 13th General Conference It is available to anyone who has
the curb if nickels are scarce, woes have on Weights and Measures adopted a new access to or who can build an atomic
been mounting. Chicago reports a del- international unit of time, the second, clock controlled by the specified cesium
uge of about 70,000 rings a month. Ideas during its last meeting here. Agreeing to radiation, and one can compare other
clicking through your mind? Unless replace the existing definition based on high-precision clocks directly with such
you have lots of old cans in the house, the earth’s orbital motion around the sun a standard in a relatively short time (an
be aware that can companies intend to by an “atomic definition,” the Conference hour or so as against years with the
change rings. decided that: astronomical standard).

qualityprogress.com ❘ January 2018 QP 13


Advice to advance your career

DECISION MAKING

Shades
testing must be documented before
a lot may be shipped. But on Friday
evening at 6 p.m., when everyone
has left for the day, you find yourself

Of Gray
standing in front of an impatient UPS
employee with a pallet of product
ready to be shipped and a lot release
record missing a date next to the
technician's signature.
Per your organization’s procedure,
this shipment should not leave your
Know the importance of analyzing facility. Per your own common sense,
everyone’s bottom line it seems ridiculous to send the UPS
employee away empty-handed and
by Denise Wrestler let the product sit in the warehouse
until Monday morning when the tech-
nician is back in the office to correct
“You can do whatever you want as long as it’s docu- his or her error.
mented and justified—and legal.” I live by this phrase, On the one hand, model QA
mostly because it’s my stock response to the age-old employees should follow the rules
question, “Are we allowed to do 'such and such'?” But 100% of the time. After all, it’s not
also because I truly believe in what it stands for. your fault the technician forgot to
As quality assurance (QA) professionals, we spend write the date. On the other hand, this
a lot of time making critical decisions that are black shipment may be what saves your
or white, yes or no, true or false, and pass or fail. But organization from losing an account
sometimes we’re confronted with decisions that fall because of another late delivery.
somewhere in the gray area between the right and How hard would it be to document
wrong answer. a minor deviation to your procedure?
In most situations, answering a question is as sim- How upset would the sales team
ple as finding the answer in a procedure or guidance be to learn something as minor as
document. For some of the more particular situations, a missing date was the reason the
however, interpreting vaguely worded regulations may product wasn’t shipped on time?
be required. What are the repercussions of your
No matter how a situation or question is handled, it is decision either way?
the responsibility of every QA professional to analyze the For larger, complex projects with
risk in the decision that is made, ensure that stakeholders many moving parts, risk analysis
involved are considered in the decision, and ensure that tools, which could require substantial
the decision is followed through. time and resources, may be used.
Failure mode and effects analysis
So many parts, so many tools (FMEA) is common in most industries
No matter how large or small the decision, risk analysis and forces an organization to look
always should be involved. For small, quick decisions, the at failure modes and their causes
possible effects of each decision should be considered. and effects, and to rank each failure
Take, for example, a typographical error on a lot- based on its severity, likelihood of
release record. Your procedure clearly states that a occurrence and likelihood of detec-
technician's signature and date verifying final lot release tion. FMEA is a great tool; however,

14 QP January 2018 ❘ qualityprogress.com


this type of risk analysis to a documentation error, you’re ultimately
might seem to be a bit Always ensure that what paving the way for other future documenta-
overkill for the situa- you decide to do, based tion errors? How critical is it that the product
tion described earlier. on your own analysis of reaches the end user as soon as possible?
Sometimes the best tool the risk and stakeholder Would your product save his or her life?
is simply old-fashioned involvement, is followed up Whatever your questions and answers may
common sense. from initiation all the way be, it’s always best to put yourself in the end
Although there are through completion. users' shoes when making a critical decision.
many ways to evaluate
risk, ensuring that a thorough analysis is performed Don’t back down
before a decision is made often is the best choice to It’s important not only to stand behind your
ensure your decision is sound. decision and defend it, if necessary, but also
to follow through and ensure that any action
Walk in their shoes items from your decision are completed.
As part of assessing risk in any decision, it’s critical to QA professionals often are tasked with the
step into the shoes of those who may be affected by unpleasant job of saying “No” when the rest
your decision. I have found that most stakeholders of the organization is saying “Yes,” or they
involved in most gray decisions fall in one of the follow- say “Yes,” but only under certain conditions.
ing categories of people: If you had released the product that Friday
1. Those who profit only when the product is sold. night, what would you have done first thing
This includes stockholders, shareholders, owners, Monday morning? Would you have issued
directors and individuals who have a direct stake in a corrective and preventive action? What
product being sold. Although you easily could argue would you suggest the organization do dif-
that everyone in an organization makes money when ferently so that you’re not faced with a similar
product is sold, only those who make money off the situation in the future? If you had decided
immediate sale fall into this category. instead to wait until Monday to ship the prod-
2. Those who profit from making the product. This uct, how would your follow-up actions on
includes an organization’s employees—from manufac- Monday morning have been different?
turing, QA and R&D to HR and office administration. Always ensure that what you decide to
All employees share in the successful completion of a do­—based on your own analysis of the risk
product from start to finish. Each department plays its and stakeholder involvement—is followed up
role, and it’s the harmony in which these departments from initiation all the way through comple-
operate that determines how efficiently the product tion. Making a decision and not ensuring that
is made and how quickly the organization can make actions are in place to make your decision a
money. reality can lead to confusion and finger-
3. Those who don’t profit financially but benefit from pointing down the road.
the product’s use. This includes the end user, custom-
ers and distributors, for example. For medical device
manufacturers, these are the patients who use the
Denise Wrestler is an
product or the health care providers who rely on the independent quality
product to work every time. assurance/regulatory
It often is best to ask yourself how your decision will assurance consultant for CYA
Medical Device Consulting in
affect each stakeholder involved. In the earlier example, Dallas. She holds a bachelor’s
how would the owner of your organization feel about degree in chemical and
you holding back product for the sake of good docu- biomedical engineering from
the University of California,
mentation practices? Would the head of manufacturing Irvine. An ASQ member, Wrestler is an ASQ-certified
respect the fact that by keeping product behind due quality auditor and engineer.

qualityprogress.com ❘ January 2018 QP 15


F E AT U R E
ISO 9001:2015

Ready or The deadline for organizations to transition to ISO 9001:2015


is fast approaching | by Govind Ramu

ISO 9001, the most widely used international standard,


was revised and published in September 2015. Orga-
nizations were given three years to transition to the new
standard, and the transition period is about to expire.
Organizations have until September 2018 to fully transi-
tion to ISO 9001:2015.1
Just the To ensure all post-audit work is completed by the
Facts deadline—including a follow-up audit, if required—most
certification bodies prefer to conduct ISO 9001:2015 tran-
The International sition audits by May 2018. If your organization is planning
Organization
for Standard- the ISO 9001 transition in 2018, contact your certification
ization issued body immediately to schedule your transition audit.
ISO 9001:2015 in
September 2015, If you miss the deadline, your ISO 9001:2008 certifica-
and organiza- tion no longer will be valid. For many organizations, ISO
tions have until
September 2018 9001 certification is a customer requirement for doing
to transition. business and required for fulfilling contractual obligations.
To ensure enough Letting your ISO 9001 certification lapse could affect
time for post- your competitiveness and ability to bid for new business
audit work, most
certification opportunities.
bodies prefer to
conduct audits by
May 2018. Where to start
The first step to transitioning to ISO 9001:2015 is to obtain
Missing the transi-
tion deadline will a copy of ISO 9000:2015—Quality management systems—
cause your ISO fundamentals and vocabulary and ISO 9001:2015—Quality
9001 certification
to lapse. management systems—requirements. Register these
documents in your external documents list and read them

16 QP January 2018 ❘ qualityprogress.com


Not
in their entirety—don’t just read the requirements (ISO
9001:2015, clauses 4-10). Clause 1—Scope provides the
intent of the standard and there are useful guidelines in
ISO 9001:2015—Annex.
If your organization is making a final push to transition
to ISO 9001:2015 before the deadline, consider this prac-
tical guidance for implementing some of the key changes
found in the new standard.

Major changes
ISO 9001:2015 introduces the following major changes:
High-level structure. The International Organization
for Standardization (ISO) created Annex SL to provide
a uniform, high-level structure, identical core text, and
common terms and definitions for all management system
standards (such as ISO 9001, ISO 14001 and ISO 37001).2
This uniform structure helps organizations that imple-
ment multiple management systems easily address the
common requirements across all management systems.
However, it’s not just about finding the same clause
reference across all management systems. Having com-
mon core text, terms and definitions makes integrating
management systems easier and reduces redundancy in
documentation, infrastructure and resources.
If you are transitioning only one management system,
such as ISO 9001 or ISO 14001, this high-level structure is

qualityprogress.com ❘ January 2018 QP 17


F E AT U R E
ISO 9001:2015

TA B L E   1

Organizational issues
External issues Internal issues
Economic situation (growth) in certain regions is not Core competency limiting organization’s ability to
conducive to grow business. make technology breakthrough.
Exchange rates are highly fluctuating. Product and service performance.

Availability of skilled employees to ramp up volume, Product and service capability.


require foreign workers.

Political instability, peace and security of Changes to top management.


business regions.
Uncertainty in continuity of trade agreements, Acquisition and mergers of organizations, cultural
possibility of potential import tariffs. challenges in sharing same vision.
Low acceptance rate of technology (more customer Product or service validation not completed, not
awareness required prior to deployment). economically scalable within a year.
Stringent regulatory requirements, approval delays, Employee performance issues, safety culture.
permitting delays.

informational only and no action is required. Orga- been a perception that it is a standard for the manu-
nizations that decide to keep their existing quality facturing industry.
manuals may prefer to align their manuals with the The current revision ensures that requirements are
new high-level structure, although it is not required. applicable to products and services. Control of moni-
ISO 9001:2015—Annex provides the following guid- toring and measuring equipment, for example, is now
ance: “There is no requirement in this International referred to as monitoring and measuring resources.
Standard for its structure and Resources can be hardware or
terminology to be applied to the survey instruments.
An organization should
documented information of an Design and development are
evaluate its business needs
organization’s quality manage- applicable to products and ser-
and expectations, risks and
ment system.”3 vices. Similar to how a physical
opportunities to determine
Less emphasis on docu- product or software is designed,
the level and extent of docu-
mentation. The current revision services also can be designed.
mented information required
significantly reduces documen- Services output also can be
to effectively manage its
tation requirements. A quality verified and its performance
quality systems.
manual and mandatory doc- validated simulating a customer
umented procedures, for example, no longer are environment. Product nonconformance is physically
required. ISO 9001:2015 only requires organizations identified and quarantined for disposition. A service
to maintain documented information about the scope nonconformance may be electronically identified as
of the quality management system (QMS), the quality a transaction identification number and analyzed for
policy and the quality objectives, and information remedial measures.
deemed by the organization as necessary for the
effectiveness of the QMS. New requirements
That said, an organization should evaluate its busi- ISO 9001:2015 also introduces the following new
ness needs and expectations, risks and opportunities requirements:
to determine the level and extent of documented Context of the organization. Every organization,
information required to effectively manage its quality large or small, should plan for its future. This happens
systems. in several ways.
Improved applicability for services. Although ISO Large organizations formally conduct strategic
9001 is applicable to all industries, there always has planning annually using tools such as environmental

18 QP January 2018 ❘ qualityprogress.com


scanning; strengths, weaknesses, opportunities and FIGURE 1
threats analysis; core competency assessments;
blind spot identification; and the balanced scorecard.
Smaller organizations, on the other hand, use their
Interested parties identification
financial performance, feedback from the market and
employee experience to assess their business and Customers
plan. Society
To understand the organization and its context, (community) Employees
external and internal issues are considered (see Table
1). Again, larger organizations consider a broad spec-
trum of issues, such as economic growth in future
market regions, currency fluctuations, availability of Industry
Investors sectors
locally trained labor forces, environmental and prod-
uct regulations, competitive landscape, scalability and
Your
long-term financial viability. organization
Smaller organizations consider issues such as mar-
ket situation, competitive situation, labor availability, Owners
and Competition
product regulatory requirements and profitability. partners
Interested parties’ identification and require-
ments. Typically, organizations formally capture or
solicit requirements from business owners, custom-
External
ers, external providers and regulatory bodies, at the Stakeholders providers
very least, to run their businesses. Requirements from Third-
party
other interested parties, such as employees, inves- auditors
tors, bankers, third-party agencies, industry groups
and the community, are solicited when needed (see
Figure 1). Preventive action to eliminate potential nonconfor-
Organizations should consider the needs and mities and corrective action to prevent recurrence of
expectations of all relevant interested parties and nonconformities, for instance, were actions to address
ensure these requirements are periodically monitored risks and opportunities.
in the QMS to ensure its long-term sustainability. Organizations applying risk-based thinking should
Table 2 (p. 20) shows common interested parties and consider using plan-do-check-act as a structured
their requirements. approach to planning and implementing actions to
Requirements and priorities from interested parties address risks and opportunities.
change from time to time. When a customer depends This requirement has been widely misunderstood,
on your organization to meet its new product launch resulting in auditors insisting on formal, documented
commitments, it might prioritize quality, delivery and risk management information. ISO 9001:2015—Annex
responsiveness. If your customer is launching a low provides guidance that “there is no requirement for
margin, high-volume product, cost and scalability are formal methods for risk management or a docu-
prioritized. mented risk management process.”5 In other words,
ISO 9001:2015—Annex A provides guidance that, “It organizations can choose the method that works for
is for the organization to decide if an interested party them.
is relevant to its quality management system.”4 Organizational knowledge. ISO 9001:2015
Risk-based thinking. There is an explicit require- requires an organization to determine the knowledge
ment in ISO 9001:2015 for risk-based thinking to necessary to operate its processes and to achieve
support and improve the understanding and appli- conformity of products and services. Some organiza-
cation of the process approach. According to ISO tions think having a document management system is
9001:2015, the concept of risk-based thinking was determining knowledge. While a document man-
implicit in previous editions. It was implied through agement system could possess knowledge acquired,
requirements for planning, review and improvement. there are several other sources for knowledge

qualityprogress.com ❘ January 2018 QP 19


F E AT U R E
ISO 9001:2015

acquisition, including: ++ Third-party benchmarking studies.


++ Post-project learning reviews. Most organizations collect knowledge through these
++ Field failure analyses. sources. However, the main challenge is maintaining
++ Customer satisfaction feedback. this knowledge and making it available when needed.
++ Closed-loop lessons-learned sessions. Often, this knowledge is either documented and
++ Analyses of business opportunities. archived on a server and is irretrievable, or it remains
++ Strategic and technology roadmap meetings with tacit knowledge and is lost when an employee leaves
customers. the organization. Many organizations must do a better
++ Business reviews with external providers and consul- job of maintaining knowledge.
tations with other subject matter experts. Another challenge is keeping up with changing
++ Seminars and conferences attended by employees. needs and trends. While larger organizations use their

TA B L E   2

Interested party requirements


Interested party Requirements
Service-level agreements, contractual requirements, nondisclosure agreements, product
Customers requirements, quality plan, lease agreement, consistent good quality products and services,
on-time delivery, minimal or zero waste, reliable partner relationship.
Customer perception, improved profitability, low risk to investment, business sustainability, zero
Business owners, majority product recall (brand reputation), social accountability, increased market share, no regulatory
shareholders violation (effective and efficient QMS), less employee turnover (morale), business continuity.

Bankers, investors Contract, bankability of projects.

Third-party auditors—finance Regulations, contractual requirements, project requirements, risk assessment.


Third-party auditors— Management system standards (ISO 9001, ISO 14001, OHSAS 18001), project contracts, CSR.
management systems
Material service agreements, nondisclosure agreements, service-level agreements,
vendor-managed inventory agreements, purchase-order requirements, supplier quality
External providers requirements, quality plan, product part approval process requirements, business continuity,
healthy relationship, long-term partnership, fair and ethical business practices.
Improved standard of living, benefits and compensation, job security, safe workplace,
Employees (full-time, part-time employment regulations (geography based), social accountability, improved morale, job
and contract)
satisfaction, work/life balance, career progression.
Regulators (product safety
and environmental, health and Regulations.
safety issues)
Industry—political action Participation, funding, inputs on issues.
committee
Industry groups and Research and development, standards development, technical publications, whitepapers,
associations industry participation, early warning indicators, best practice sharing.
Joint venture Joint venture agreement, contracts.
Compliance to bylaws, environmental sustainability, benefit local business and economy, hire
Society local labor, corporate citizenship, education and charitable foundations.
Competition Market intelligence, customer perception, competitive benchmarking.
Opposing groups Public policy, industry-specific subsidies, tariffs, regulations.

CSR = customer specific requirements


ISO = International Organization for Standardization
OHSAS = Occupational Health and Safety Assessment Series
QMS = quality management system

20 QP January 2018 ❘ qualityprogress.com


infrastructure and resources to acquire and maintain REFERENCES
new knowledge, smaller organizations could consider 1. International Accreditation Forum, Inc., “Transition Planning
Guidance for ISO 9001:2015,” Jan. 12, 2015, https://tinyurl.com/
membership and participation in industry groups lsett9k.
and associations to acquire or access any necessary 2. Stefan Tangen and Anne-Marie Warris, “Management
additional knowledge and required updates. ASQ Makeover—New Format for Future ISO Management System
Standards,” International Organization for Standardization
membership and participation in U.S. technical advi- (ISO), July 18, 2012, https://tinyurl.com/y8j95bsn.
sory groups, for example, keeps organizations updated 3. ISO, ISO 9001:2015—Quality management
about quality management and standards. systems—requirements.
4. Ibid.
5. Ibid.
Don’t wait
If your organization has been meeting the intent of BIBLIOGRAPHY
International Organization for Standardization (ISO), ISO/Techni-
earlier versions of ISO 9001, the transition to the cal Specification (TS) 9002:2016—Preview quality management
revised standard should not be a major undertaking. systems—guidelines for the application of ISO 9001:2015.
ISO 9001:2015 implementation is not an expensive ISO, ISO 9000:2015—Quality management systems—fundamen-
tals and vocabulary.
activity that requires high-priced consultants to hold
your hand through the transition. ASQ has several
resources to help you, including its Quality Resources
page (asq.org/quality-resources) and the Ask the Govind Ramu is a licensed professional
Experts blog (asqasktheexperts.com), QP’s Standard engineer from Ontario, Canada. He
Issues and Expert Answers columns, and the ISO also is the chair of the U.S. Technical
Advisory Group to International
9001:2015 references infographic on pages 22-23 of Organization for Standardization
this issue of QP. Technical Committee (ISO/TC) 176,
Your certification body is another great resource. subcommittee (SC) 1 on ISO 9000:2015
standards and the convener for ISO TC 176/SC3 working group
Most certification bodies provide free webinars, 23 for ISO 10014. Ramu is an ASQ fellow, ASQ Crosby Medal
transition guidelines, checklists and interpretation recipient and holds six ASQ certifications: manager of quality/
guidelines to their clients—just ask. organizational excellence, engineer, Six Sigma Black Belt,
auditor, software quality engineer and reliability engineer. He is
The September 2018 transition deadline will be an author of The Certified Six Sigma Yellow Belt Handbook (ASQ
here before you know it—don’t wait!  Quality Press, 2016).

qualityprogress.com ❘ January 2018 QP 21


The Clock Is
ISO 9001 resources
These webpages gather different resources
related to the revision, and present specific
links to books, articles, case studies, videos,
webcasts and training opportunities.
asq.org/quality-resources/iso-9001
asq.org/learn-about-quality/
iso-9000/iso-9001-2015

Training courses
Comprehensive classroom and web-based
courses get you trained on the revised standard:
++ “ISO 9001:2015—The Path Forward.”
++ “ISO 9001:2015 Comprehensive Transition Training:
Clause By Clause Concepts And Requirements.”
++ “ISO 9001:2015—Auditor Transition Training.”
++ “ISO 9001:2015 An Overview.”
++ “Documentation in ISO 9001 Training.”
++ “ISO 9001:2015 Requirements From A To Z.”
asq.org/training/catalog

ASQ member gifts


Three previous ASQ member gift bundles—from April 2015,
October 2015 and June 2016—collect many resources to
strengthen your fundamental understanding of standards, as
well as provide critical updates on the revision and transition
strategies.
asq.org/quality-resources/iso-9001

Articles
Do you feel the need to read? Curl up with one of many arti-
cles on different aspects of the revision from the last several
years. Here's just a small sample:
++ “Keep Calm and Prepare for ISO 9001:2015.” Basic anal-
ysis of ISO 9001:2015 and what the changes mean, how to
meet the new requirements, and resources available.
qualityprogress.com
++ “Read, Set, Transition.” Effective ISO 9001:2015 transi-
tioning strategies. qualityprogress.com
++ “All Hands on Deck.” A template on what ISO 9001:2015 is,
why it changed, and how it affects your staff.
Ask the Standards
qualityprogress.com Experts blog
++ “The Influence of Human Factors on ISO 9001:2015 Com- Got a question? Ask the ASQ experts,
pliance.” Changes in the revision that focus more on the who have already weighed in on many
people within an organization. asq.org/pub/jqp ISO 9001:2015-related queries from those
transitioning to the new standard.
asqasktheexperts.com
22 QP January 2018 ❘ qualityprogress.com
Ticking
Time is running out. But ASQ’s got
you covered. Since the revision to the
international ISO 9001 standard was
published in 2015, ASQ has become
the central hub for information on key
developments of ISO 9001:2015 and
advice on transitioning to the revision.
Here are just some of those resources
and where you can find them.

Books
ASQ Quality Press has published several books related to
the revision. Here are a few favorites:
++ ISO 9001:2015 Explained, fourth edition.
++ ISO 9001:2015 Handbook for Small and Medium-Sized
Businesses, third edition.
++ ISO 9001:2015 Internal Audits Made Easy, fourth edition.
++ ISO Lesson Guide 2015, fourth edition.
++ The ISO 9001:2015 Implementation Handbook.
++ How to Audit ISO 9001:2015.
++ The Magic of ISO 9001: How to Make It Fully Materialize.
++ A Practical Field Guide for ISO 9001:2015.
asq.org/quality-press

Webcasts
On-demand presentations from experts on topics such as:
++ “ISO 9001:2015—Elevating Quality With Risk Based Thinking."
++ “Guidance on Conforming to ISO 9001:2015—
Advice and Examples From an Auditor.”
++ “ISO 9001:2015 for Small and Medium-Sized
Businesses.”
++ “Document Control System Compliance.”
asq.org/quality-resources/webcasts

Standards Central
A collection of ASQ resources and news about management systems
standards, including ISO 9001:2015, ISO 14001 and ISO 9000.
asq.org/quality-resources/standards
asq.org/knowledge-center/standards/standards-iso-9001-2015.html

ASQTV
30+ interviews with top experts on the revision to help you prepare.
Topic areas include the basics of the revision, key changes such as
risk-based thinking, the effect on industry and transition tips. Here
are a few specific topics:
The Standard ++ “Selecting an ISO 9001 Registrar and Consultant.”
Still neeed a copy? ISO 9001:2015: ++ “Transitioning: Advantages, Expected Investment and Advice.”
Quality management systems— ++ “Transitioning: Auditing Considerations.”
Requirements is available at: ++ “ISO 9001:2015—15 Things You Must Know Now.”
asq.org/quality-press/ ++ “ISO 9001:2015: Your Big Questions Answered.”
display-item?item=T1040 videos.asq.org/product-category/channel/quality-standards

qualityprogress.com ❘ January 2018 QP 23


F E AT U R E
ISO 9001:2015

Just the
Facts
Before transi-
tioning to ISO
9001:2015, first
take the time to
understand how
the standard is
structured around
seven quality man-
agement principles.

Allocate enough
time and resources
to properly plan
and set realistic
deadlines. Man-
agement must be
there to provide
adequate support,
including the
resources neces-
sary to meet the
project goals and
deadlines.

Don’t overlook
the importance of
finding the right
registrar early in
the process.

24 QP January 2018 ❘ qualityprogress.com


the
Under Wire
Last-minute advice to successfully implement
or transition to ISO 9001:2015 | by Mark Durivage

As the deadline to transition from ISO 9001:2008 to


ISO 9001:2015 approaches later this year, there are many
organizations still asking the question, “How do we get
certified successfully?”
The answer is not as straightforward as you might think.
Much preparation and thoughtful planning must occur to
address a process that can be complex and confusing for
some organizations.
But before looking at ways to make the implementation
or transition as smooth as possible, it’s helpful to understand
how ISO 9001:2015 is structured—namely, around seven quality
management principles (Figure 1, p. 27).

qualityprogress.com ❘ January 2018 QP 25


F E AT U R E
ISO 9001:2015

Seven principles of ISO 9001:2015 4. Process approach


1. Customer focus The process approach in a quality management
Customer focus is probably one of the most system (QMS) can help organizations under-
important of the seven quality management stand and meet requirements consistently, attain
principles. Without customers, organizations effective process performance, and improve
cannot survive. Today, more than ever, customers processes based on evaluation of data and
have ready access to choices due to the prolif- information.
eration of the internet and social media. When Systems are comprised of processes;
organizations supply products and services that processes are comprised of subprocesses; sub-
fail to meet customer needs and expectations, processes are comprised of tasks; and tasks are
customers will migrate to products and services comprised of subtasks. For a system to properly
provided by competing organizations. function effectively and efficiently, the processes,
Understanding customer needs (current and subprocesses, tasks and subtasks must be inter-
future) will contribute to the sustained organi- related. The output of one process can be the
zational success through increased customer input for the next process. Basically, a process
perception, satisfaction and loyalty. Understand- can be defined as value, which is added to an
ing customer requirements (stated and unstated) input with the result of an output.
is not only a good idea, it’s also an ISO 9001:2015 The process approach also helps integrate
requirement. ISO 9001:2015 clause requirements into an
2. Leadership interrelated system in which all the subsystems
Leadership is charged with the task of aligning (clauses) are mutually supportive and comple-
the organization’s tactics, strategies, policies, mentary to one another. The process approach
processes and resources to achieve its objectives will help reduce or eliminate the silo effect
with the purpose of increasing effectiveness and caused by processes that are not mutually sup-
efficiency by ultimately enhancing the customer portive and complementary to one another.
experience. 5. Improvement
Leadership not only involves the top man- An ongoing focus on improvement is necessary
agement of an organization, but it also includes for organizations to survive and thrive. What is
middle management, supervisors and workers. acceptable today may be unacceptable tomor-
An organization with leadership that leads by row. Maintaining performance levels, reacting
example and empowers its people will continu- to changes in internal and external risks and
ously improve and meet the needs of customers opportunities, and creating opportunities for the
and other interested parties. organization are among the benefits of continual
3. Engagement of people improvement. Benchmarking is a commonly
For an organization to be successful and enhance used tool to evaluate the organization’s policies,
its capabilities, the organization must create procedures, practices, processes, products and
and deliver value by engaging its people. The services.
engagement of employees is necessary for orga- 6. Evidence-based decision making
nizational survival. Employees who are engaged Evidence-based decisions using data analysis
will contribute to the organization’s accom- are generally more effective than using just
plishment of goals and objectives. Disengaged anecdotal information. Even evidence-based
employees will not support organizational goals decisions contain a degree of uncertainty. Making
and objectives. data-driven decisions can help reduce the level
Engagement can be accomplished through of uncertainty, which leads to a higher level of
communication and empowering employees by confidence in the decisions being made.
delegating responsibility for processes they own. In turn, good decisions lead to good results.
Offering professional development and training Statistical process control, capability studies,
opportunities is an excellent way to engage peo- design of experiments, correlation analysis, linear
ple and motivate them to their fullest potential. regression, hypothesis testing, trend analysis,

26 QP January 2018 ❘ qualityprogress.com


cause and effect diagrams and Pareto anal- FIGURE 1

Quality management principles


ysis are just a few tools that can be used to
make evidence-based decisions.
Evidence-based decisions also can support
risk-based thinking, a new concept intro-
duced in ISO 9001:2015. Risk-based thinking
is crucial for the development, implementa- Customer
focus
tion and improvement of a QMS. Risk-based
thinking is really a two-step process. First, the
Relationship
organization must identify, analyze, evaluate, Leadership
management
reduce and accept risk. Next, the organization
must recognize and exploit opportunities by
increasing the effectiveness of the QMS.
Risk-based thinking will allow an orga- Quality
nization to focus its efforts on consistently management
Evidence-
providing products and services to meet principles
based Engagement
customer requirements and expectations, decision of people
while also enhancing customer satisfaction. making
Applying risk-based thinking allows an orga-
nization to focus and apply resources in an
effective manner.
Process
7. Relationship management Improvement
approach
For organizations to be successful, they must
manage their relationships with relevant
interested parties, another new concept intro-
duced in ISO 9001:2015. Interested parties
can be defined as those parties (individuals,
companies, groups, communities and govern- and external factors. The context of the organization
ment) that present risks to the organization’s can provide guidance for the organization for tactical
future if their expectations and needs are not and strategic decisions, and help develop, deploy,
met. They can include employees, sharehold- monitor and maintain the organization’s vision, mis-
ers, investors, customers, suppliers, regulators sion, policies and objectives.
and the community.
Poorly managed relationships can be Considerations for getting certified
disastrous and negatively affect the organiza- The first step in implementing, transitioning or
tion. Relationship management helps ensure updating a QMS begins with understanding the
communication between interested parties, requirements and expectations of the standards and
which can optimize these parties’ impact on registrars. It’s highly recommended to purchase a
the organization’s performance and facili- legal copy of the following documents:
tate a mutual understanding of each other’s ++ ISO 9001:2015—Quality management
requirements and positions. system—requirements.
Interested parties is more than customer ++ ISO 9000:2015—Quality management systems—
focus. Understanding the context of the orga- fundamentals and vocabulary.
nization—yet another new concept introduced ++ ANSI/ISO/ASQ 9004-2009—A quality manage-
in ISO 9001:2015—is identifying interested ment approach—managing for the sustained
parties. Understanding the context of the success of an organization.
organization determines factors that influence ++ ISO 10002:2014—Quality management—customer
the organization’s purpose, objectives and satisfaction—guidelines for complaint handling in
sustainability. This process considers internal organization.

qualityprogress.com ❘ January 2018 QP 27


F E AT U R E
ISO 9001:2015

++ ISO 19011:2011—Guidelines for auditing One approach may be to use a consultant


management systems. well versed in the standard and its applica-
Read them and make sure they are tion to your industry. There are likely many
understood by those responsible for the consultants who thoroughly understand the
QMS. Again, make sure that you purchase standard requirements, but there may be
the actual documents. They are copyrighted only a few who can apply the standards to
materials. Downloading “free” copies is ille- your industry. There’s one local tattoo parlor
gal, and they may not be the actual standard. that advertises: “A good tattoo ain’t cheap,
If these standards aren’t thoroughly and a cheap tattoo ain’t good.” In other
understood, it’s unlikely your organization words, you get what you pay for.
will be able to demonstrate compliance, If your organization is considering using a
and your chances of getting certified will be consultant, ask him or her for references from
diminished. other organizations that he or she helped

Certification Considerations
CONSIDER THESE POINTS TO COMPLY WITH EACH OF THE
10 CLAUSES CONTAINED IN ISO 9001:2015.

1. Scope: When determining the approach—managing for 5. Leadership: This section is a


scope of the quality manage- the sustained success of an good place to determine man-
ment system (QMS), consider organization. agement’s responsibility and
the processes necessary for ++ ISO 10002:2014—Quality determine the quality policy
improvement of the system, management—customer and objectives. One way to help
and conformity of products and satisfaction—guidelines comply with this section is to
services by meeting customer for complaint handling in develop an organizational chart
expectations and compliance organization. and job descriptions that clearly
with applicable statutory and ++ ISO 19011:2011—Guidelines for delineate responsibilities and
regulatory requirements. This auditing management systems. authority.
is also the place to state that 3. Terms and definitions: ISO 6. Planning: The organization
the QMS is compliant with the 9000:2015—Quality management should consider the risks and
requirements of ISO 9001:2015. systems—fundamentals and opportunities for the entire
2. Normative references: ISO vocabulary should be purchased organization. Risks and oppor-
9000:2015—Quality management and understood. Best practice is tunities can be identified and
systems—fundamentals and to use the concepts and terminol- documented using strengths,
vocabulary should be purchased ogy where applicable to provide weaknesses, opportunities and
and understood. Best practice is consistency. This is also a great threats analysis and political,
to use the concepts and terminol- place to include any organiza- economic, social, technological,
ogy where applicable to provide tional terms and definitions. legal and environmental issues
consistency. This also is a good 4. Context of the organization: analysis. Quality objectives
place to list the standards neces- The context of the organization should consider and include
sary to develop and support the should be documented. Consider the key process performance
QMS, including: the interested parties and their measures identified in Section
++ ISO 9001:2015—Quality man- needs, and how the organization 4—Planning.
agement system requirements. will address their needs. This sec- 7. Support: Demonstrating
++ ISO 9000:2015—Quality tion also discusses the QMS and employee competence by using
management systems—funda- its processes. This is an appro- task-based training is the best
mentals and vocabulary. priate place to identify the key method to comply with aware-
++ ANSI/ISO/ASQ 9004- parties and processes necessary ness requirements. Best practice
2009—A quality management to support customer satisfaction. is to maintain a training matrix,

28 QP January 2018 ❘ qualityprogress.com


to implement a QMS or to transition to the the costs of hiring a consultant.
updated standard. Request references from Effectively planned project management
organizations of similar size, industry and and—above all—reasonable exceptions by top
complexity so you can make an informed management are crucial to successfully securing
decision on experience, training, education ISO 9001:2015 certification. The organization
and cost. should realistically expect the certification pro-
If your organization decides to use internal cess to take between six to 12 months. Anything
personnel to develop and implement a less than that will probably result in several certi-
QMS, it’s essential that those responsible be fication audit nonconformances, which will delay
appropriately trained and, more importantly, the issuing of an ISO 9001:2015 certification.
afforded time to complete the work. Your Furthermore, a poorly planned and rushed
organization should consider the costs asso- implementation will probably result in a strained
ciated with using internal resources versus relationship with the organization’s registrar.

which indicates the employee grid listing supplier risk (low, status. Additionally, using
level of competence for each medium and high) and applying the specific, measurable,
job or function. more controls to high-risk achievable, relevant and time
Monitoring and measuring suppliers is an effective way to bound approach is a good way
resources (calibration) is best manage supplier and receiving to determine verification of
supported by a spreadsheet or inspection requirements. effectiveness requirements.
computer program that pro- 9. Performance evaluation: Although ISO 9001:2015
vides a visual calibration status. Performance evaluation should does not require a quality
Using a document change order include a comprehensive manual, I strongly suggest
(DCO) form and index is a great internal audit program using the creating one. The manual
way to manage document and process approach that audits by provides a good, high-level
engineering changes. The form the key processes identified in overview of the QMS and can
should include a checklist of Section 4—Planning. help employees understand
consideration and activities to A standardized agenda the processes and their
ensure changes will not have an and minutes for management interactions. Additionally, a
unintended negative impact on review are necessary to ensure quality manual is a great tool
products, services and the QMS. compliance with ISO 9001:2015. to provide customers and
8. Operation: One of the best I suggest adding more topics, potential customers during
practices is the integration of including an assessment of the audits. The quality manual
the work instruction in the batch context of the organization, also is a great place to include
record. This helps ensure the interested parties, and whether a compliance matrix. The
most recent work instruction there are any new risks and purpose of a compliance matrix
is available at the point of use opportunities. is to provide a table of the ISO
and the employees are using Using an action item log is a 9001:2015 requirements and
the documentation. Many great way to provide visibility where they are addressed.
organizations also use photos to actions assigned during ISO 9001:2015 also does not
in the work instructions to management review and require the appointment of a
clarify specific tasks, including prevents the action items from management representative.
inspections. Photos also are slipping away. Again, I strongly suggest
used to document quality alerts 10. Improvement: An issue appointing a designated
to make the operators and management log is a valuable individual to the role of
inspectors aware of previous tool to capture audit findings, management representative
quality issues. nonconformance reports, (usually a person from the
Maintaining a risk-based supplier corrective action quality function) so that
supplier program is a good requests and complaints. consistent messaging can be
way to focus the organization’s The log is most useful when maintained during certification,
limited resources where they due dates are assigned, and registration and supplier audits.
are needed most. Creating a color coded to indicate their —M.D.

qualityprogress.com ❘ January 2018 QP 29


F E AT U R E
ISO 9001:2015

Best practice is to include a discussion and assign ++ Clause 8.5—Product and service provision.
project responsibilities during regular management ++ Clause 8.6—Release of products and services.
meetings. If already certified, record the responsibili- Processes that require more customization need an
ties in the management review minutes or action item active, hands-on approach by the organization. These
log. processes must be understood and documented.
Another piece of advice when transitioning to Consultants who say, “This is the way it should be
ISO 9001:2015: Get buy-in from those who will be done” are not doing their job. I have seen many QMSs
affected. It is important to include the affected team that were implemented by consultants that were not
members in the implementation process. Share with fully embraced, resulting in a QMS that was literally
them the risks of not having the certification and the square peg in the round hole with less-than-favor-
the opportunities the organization may enjoy after able results. Even if the organization is not currently
becoming certified. certified with documented processes, there are still
Management also must fully support the certifi- processes and interactions in place that must be
cation process by being actively engaged, providing thoroughly understood.
resources necessary for a successful implementation An additional consideration is that, “One size does
or transition, and keeping the entire organization not fit all.” A QMS for an organization with 20 employ-
informed of the project’s status. As an auditor, it’s ees will probably not suffice for an organization with
easy to identify whether management is involved and 200 employees, just as a QMS for an organization
engaged. Just because they attend opening and clos- with 20 remote employees will probably not work for
ing meetings does not guarantee they are involved an organization with 20 employees at one facility.
and engaged. Organizations with multiple facilities also should
consider a common QMS. One advantage of this
Customization is critical is when corrections are made due to audits and
From my experience, purchasing an off-the-shelf customer complaints, for example. Corrections can
ISO 9001 system rarely works. Of course, in my be deployed to the entire organization, potentially
consulting practice, there are “canned” procedures. preventing the same issues at other facilities.
But procedures always must be modified to fit the
situation. Certain processes require less customiza- The right registrar
tion, including: Choosing the proper ISO registrar is also extremely
++ Clause 6.1—Risks and opportunities. important. Make sure the registrar is accredited by
++ Clause 7.1.5—Monitoring and measuring resources. a reputable third-party accreditation agency. For
++ Clause 7.2—Competence awareness and training. example, ANSI-ASQ National Accreditation Board is
++ Clause 7.4—Communication. the most widely recognized third-party accreditor for
++ Clause 7.5—Documented information. QMSs.1
++ Clause 8.7—Nonconforming outputs. I recently encountered my first organization that
++ Clause 9.1—Monitoring measurement analysis and used an unaccredited registrar for ISO 9001 cer-
evaluation. tification. While preparing for the audit, I noticed
++ Clause 9—Internal audit. the organization’s quality manual was last revised
++ Clause 9.3—Management review. in 2006, and the ISO certification was for ISO
++ Clause 10.2—Corrective action. 9001:2008. This was my first experience with a
Certain subsystems require more customization, “certification mill.” The way this unaccredited registrar
such as: worked was the organization had to send a check
++ Clause 7.1—Resource management. along with its annual internal audit, and magically, a
++ Clause 8.1—Operational planning and control. certificate would arrive a few days later.
++ Clause 8.2—Requirements for products and The registrar also should be investigated to ensure
services. it has the auditor expertise that aligns with the
++ Clause 8.3—Design and development of products organization’s products and services. For example, it
and services. would not be appropriate for a certification auditor
++ Clause 8.4—Externally provided processes, prod- with a customer service background to audit a man-
ucts and services. ufacturer of printed circuit boards. Have the registrar

30 QP December 2017 ❘ qualityprogress.com


A Successful
Implementation
Recently, a small manufacturing organization was looking for help
setting up an initial ISO 9001:2015 quality management system (QMS).
When I arrived, I was given a binder of templates, forms and proce-
dures purchased online. The quality manager explained he had invested
between 60 to 80 hours modifying the documents, and asked me to help
finish the project and get the organization certified. The organization
was also adamant about only including certain portions of the business in
the scope of the QMS.
To begin the project, I recommended a highly reputable ISO registrar
I had worked with in the past. The quality manager was skeptical, but I
assured him the registrar was accredited by the ANSI-ASQ Accreditation
Board. Getting the organization to agree to use this registrar was the
deciding factor for me to accept the project.
By the way, did I mention the organization needed the certification
yesterday?
From there, I explained that the most significant aspect of successfully
provide organizational references developing, deploying and ultimately becoming ISO certified is two-fold:
for companies that are of similar 1. Management must want the certification to improve the business—and
not just to post a paper on the wall or website.
size, industry, and complexity so
2. The organization must be included in all aspects of the QMS develop-
an informed decision that consid- ment. If a QMS is dumped in the organization’s lap, the organization
ers experience and cost can be will never be fully and effectively implemented. That is why a consul-
made. tant must also be a teacher, coach and mentor, and he or she must be
patient.
As a consultant, the point at which I become confident that the project
Planning required will be successful is when those responsible for the QMS began asking the
The key to a successful imple- right questions. For example, should this nonconformance be elevated to
mentation of or transition to ISO a corrective and preventive action? Should there be additional manage-
9001:2015 is proper planning with ment reviews? Even though it is not required in the standard, should we
realistic deadlines and manage- proceduralize the process? For me, that is the most satisfying aspect of
the project.
ment providing adequate support,
Another challenging aspect is having the organization map its busi-
including the resources necessary ness processes. As a consultant, there is only so much you can do without
to meet the project goals and the client fully understanding how the business process works. After the
deadlines. business processes are mapped, recommendations to enhance and doc-
Thoroughly investigate any ument the processes become easier. This phase of the project is always
the most resource intensive, especially by the organization’s staff.
consultant that may be used,
Eventually, this small manufacturer received its initial ISO 9001:2015
research the registrar and con- certification without any findings from a tough auditor. —M.D.
tract with the registrar early in the
process because it may have cer-
tain expectations to help ensure a
successful certification. Mark Durivage is managing principal consultant at
Quality Systems Compliance LLC in Lambertville,
NOTE MI. He earned his master’s degree in quality
1. To verify whether a registrar is management from Eastern Michigan University
accredited, visit http://anabdirectory. in Ypsilanti. He is an ASQ fellow and holds several
remoteauditor.com. ASQ certifications, including quality auditor,
biomedical auditor, HACCP auditor, pharmaceutical
good manufacturing practices professional, Six
Sigma Black Belt and manager of quality/organizational excellence.
Durivage also authored and edited several ASQ Quality Press books.

qualityprogress.com ❘ December 2017 QP 31


F E AT U R E
STANDARDS

Just the
Facts
A recent study—
centered on
management
systems stan-
dards—examined
three areas: the
diffusion and
adoption of the
standards, the
impacts of the
standards, as well
as the governance
of them.

The study had


many findings
with implications
for managers and
auditing bodies.

Many questions
remain unan-
swered. More
input from the
management
systems standards
community, how-
ever, could open
the door for addi-
tional research
and insight.

32 QP January 2018 ❘ qualityprogress.com


No
Joking
Matter
Research analyzes management systems
standards and the implications for managers
and auditing bodies
 

by Pavel Castka and Charles J. Corbett

You might think that ISO standards for management systems


are too dry to evoke much passion. But the many derogatory
Dilbert cartoons and other jokes—as well as heated discussions
on LinkedIn groups and elsewhere—prove otherwise.
To what extent is this unflattering attention deserved? What
do we actually know about these standards?
Management systems standards (or meta-standards) deter-
mine requirements for organizational systems and are designed
for all types of businesses. These standards cover a broad
spectrum of management areas (see Table 1, p. 34), and organi-
zations usually gain certification to them through independent
third parties.
We have reviewed more than 2,000 scientific studies on
management systems standards and published the findings
in a research monograph.1 This article summarizes the key
arguments from the monograph. All of the studies considered in
the monograph covered three broad areas:

qualityprogress.com ❘ January 2018 QP 33


F E AT U R E
STANDARDS

1. Diffusion and adoption difficult to get a quick overview. In


of standards: Who adopts Some of the fundamental this article, we highlight the main
management systems questions have been (partly) takeaways from this literature, focus-
standards and why? How answered, but there is a lack ing on the implications for managers
did the standards spread of publicly available data and auditing bodies.
across countries? What do to investigate many other
organizations actually do to important points. The main findings
get certified? How does that Some questions have been stud-
vary across firms? ied extensively enough that there
2. Impacts of management sys- are reasonably clear answers.
tem standards: Does certification to a particular For instance, Table 2 summarizes the state of the
standard help an organization perform better in literature on the effect of ISO 9000 certification on
that domain? That is, do organizations with ISO a variety of financial performance measurements,
9000 certification have better quality, and are revealing that the evidence tilts toward a positive
organizations with OHSAS 18001 certification safer? relationship.
Are certified organizations more profitable? Other areas, such as those related to the gov-
3. Governance of management systems stan- ernance of management systems standards, have
dards: How substantive are these management received nowhere near the same scrutiny. The
systems standards? How consistent are they across scientific community may be arriving at a crossroads:
firms and over time? How do the actual standards Some of the fundamental questions have been
maintain relevance and credibility over time? (partly) answered, but there is a lack of publicly avail-
This scientific literature is huge, but it is also hugely able data to investigate many other important points.
disconnected and spans many disciplines, making it Overall, the main findings from the review are:

TA B L E   1

Overview of management systems standards


Standard Description Developer
Series of standards for quality International Organization for
ISO 9000 management systems (QMS) Standardization (ISO)
Quality standard for automotive
QS9000 General Motors, Chrysler and Ford
industry

TS16949 QMS standard for automotive industry ISO

Series of standards for environmental


ISO 14000 ISO
management systems (EMS)
EMAS Series of standards for EMSs EU
Series of standards for social
AA1000 AccountAbility
accountability
SA8000 Standard for social accountability Social Accountability International
International guidance standard on
ISO 26000 ISO
social responsibility
Occupational Health and Safety
Standard for occupational health
OHSAS 18001 Assessment Series (OHSAS) Project
and safety Group
CMM Capability maturity model Software Engineering Institute

34 QP January 2018 ❘ qualityprogress.com


++ The evidence points to a positive effect of ISO 9000 TA B L E   2
certification on various measurements of operational
performance (such as inventory days, accounts receiv-
able, operating cycle time or waste) and financial The effect of ISO 9000
performance. The evidence on ISO 14000 certifica-
tion is weaker, but it does imply a positive effect on certification on financial
environmental performance and perhaps financial
performance. performance
++ Organizations choose to adopt ISO 9000 and ISO
14000 (and other management systems standards) for Findings from the
Effect of ISO 9000 on: literature:
a variety of reasons, ranging from a desire to improve
Mostly positive, some
performance, to increase sales and exports, to follow- Sales neutral
ing the examples set by other firms.
Revenue Neutral
++ The depth of implementation of a standard varies sub-
Return on equity Positive and neutral
stantially across organizations, and this variation has
consequences: Organizations that adopt standards in Mostly positive, some
Return on assets neutral (especially for
a more substantial manner tend to reap greater bene- late adopters)
fits than those in which adoption is mostly symbolic or
Return on sales Mostly positive
ceremonial.
Mixed evidence on
++ The global spread of management systems standards Stock market returns short-term returns
occurs among countries that are neighbors or that
have strong trade relations or cultural ties. After one
Note: This table summarizes the findings reported
standard has spread widely, such as ISO 9000, that in Tables 3.3 and 3.4 in Paul Castka and Charles
eases the way for other related standards to diffuse J. Corbett’s, “Management Systems Standards:
Diffusion, Impact and Governance of ISO 9000,
quickly. ISO 14000, and Other Management Systems
++ The governance of management systems standards Standards,” Foundations and Trends in Technol-
ogy and Operations Management, Vol. 7, Nos. 3-4,
(that is, how the standards are set and reinforced) 2015, p. 239 and p. 248. The results are based on
displays inconsistencies, including in certification and findings from 20 studies published in the most
credible peer-reviewed academic journals, based
accreditation, but the lack of data has, so far, inhibited on data from the United States, Spain, Singa-
any definitive study of this issue. pore, Germany, Hong Kong, Pakistan and other
countries, often involving matched samples of
hundreds of certified and non-certified organiza-
tions. A detailed description of individual studies
Implications for managers is provided in “Management Systems Standards:
On average, firms can expect some benefits from man- Diffusion, Impact and Governance of ISO 9000,
ISO 14000, and Other Management Systems
agement systems standards, evidence suggests. Standards.”

qualityprogress.com ❘ January 2018 QP 35


F E AT U R E
STANDARDS

The studies have shown, for certification internally.


instance, that ISO 9000-cer- Organizations that plan deep That means they must develop
tified firms (on average) implementation may choose an approach to determine when
outperform noncertified more reputable certification a supplier’s ISO 9000 or other
firms along various financial bodies—which, in turn, deliver certification is adequate protec-
and other metrics. Managers better auditing services, tion and when they might need
should not expect much (if any) hence also leading to a deeper additional reassurance.
stock market reaction to their implementation.
certification effort. Adopting Implications for
ISO 9000 or ISO 14000 does, auditing bodies
however, provide an opportunity for a wide range of As much as certification may, on average, add value,
potential benefits. the impact of individual certification bodies is less
Studies show a positive effect of ISO 9000 on clear. There are hundreds of certification bodies
workplace injury rates and safety performance, across the globe that compete for clients. 2 The
for instance, as well as growth in employment and research demonstrates that there is much variation
improvement in organizational climate.  among certified organizations, but it also suggests
Unfortunately, the precise benefits are quite there is variation among certification bodies
difficult to predict and quantify, which means that themselves.
traditional (narrow) cost-benefit analysis is not the Some initial findings even suggest that organiza-
right way to decide on certification. One factor under tions that seek a minimal adoption of the standards
managerial control that influences whether the effort might shy away from the most credible certifica-
will be beneficial is the depth of implementation: More tion bodies. Combined, these findings suggest that
genuine implementation is more likely to yield better as much as the average and aggregate effects of
results. certification appear positive, some of the variation in
While developing this standards competence, man- the effects is likely due to organization-specific and
agers should be mindful of the substantial variation auditor-specific factors.
in the quality of implementation of ISO standards and Unfortunately, apart from identifying this variation,
their governance. This variation is largely a function there is a lack of empirical evidence on more nuanced
of management choice: Managers are in the driv- aspects of the role of certification bodies, such as
er’s seat when it comes to making the most of the their competence, consistency over time and ethical
certification in their organization, and they also have a conduct. This is largely due to poor data availability,
wide selection of consultants and certification bodies we speculate, and we encourage certification and
to choose from to help them in that effort. From an accreditation bodies to share data on their auditing
internal perspective, managers must ensure they practices and outcomes with researchers to allow
implement the standard in a way that is favorable to deeper understanding of these issues.
their organizations. Certification bodies should consider two other
They also must mobilize internal resources and findings from the empirical studies:
competencies to develop a system aligned with 1. Organizations that deeply implement management
their organization’s strategy and that recognizes the systems standards outperform other organizations.
unique nature of their organization. The external vari- 2. Organizations often find it difficult to determine the
ation is, however, more difficult to manage.  benefits of certification.
Managers might be working with other organi- Certification bodies could consider the extent to
zations in their supply chain that are certified, for which they enable “deep” implementation. This could
example, but it is often difficult to directly observe the mean providing evidence of their clients’ performance
quality of implementation of a management systems improvements and helping their clients document
standard in the organization’s supply chain.  and quantify a wider range of benefits.
Managers must recognize that there will likely Some emerging literature also suggests that the
be variation in how their suppliers manage the way organizations choose their certification bodies

36 QP January 2018 ❘ qualityprogress.com


depends on their motivation for certification. For to determine the performance of participating
instance, organizations that plan deep implemen- organizations.
tation may choose more reputable certification For instance, having detailed audit reports would
bodies—which, in turn, deliver better auditing enable researchers to study the effect of the level of
services, hence also leading to a deeper implemen- compliance on firms’ performance. Rejection data
tation. Literature on this theme is immature, but from certifiers would enable researchers to study the
this early finding suggests that the marketplace is impact of the certification more thoroughly. Likewise,
inconsistent. having access to complaints from organizations to
accreditation bodies about suppliers who are certified
More questions to answer but fail to live up to the corresponding expectations
From this summary of the literature, 3 we conclude would shed light on the level of audit scrutiny by
there is enough ambiguity surrounding management various certifiers.
systems standards that the cartoons, jokes and dis- Finally, it would be helpful to get more insight from
cussions referred to earlier do reflect the state of the executives and purchasing directors: Is ISO certifica-
research. tion still a relevant qualifier for purchasing policies?
Although there is reason for some cautious opti- Having performance data on a large set of suppliers
mism about the overall average effect of standards on can help to answer such questions.
organizational performance, there is also reason for
some concern about the lack of consistency—among REFERENCES AND NOTES
organizations and auditors. 1. This article is based on a research study on ISO 9000,
As researchers, we urge any individuals and ISO 14000 and other standards, written by Pavel Castka
and Charles J. Corbett, “Management Systems Standards:
organizations in the management systems standard Diffusion, Impact and Governance of ISO 9000, ISO 14000,
community who share these concerns to find ways to and Other Management Systems Standards,” Foundations
work with researchers to probe these issues. That will and Trends in Technology and Operations Management, Vol.
7, Nos. 3-4, 2015. The 232-page manuscript was based on
mean providing access to data related to the certifica- an analysis of 2,836 academic studies published in top
tion and accreditation process, the standard-setting academic journals and discusses about 250 studies in detail.
mechanisms and more. The review provides a comprehensive overview of findings
from the management systems standards literature. 
Such data may seem too sensitive to share with 2. The International Accreditation Forum provides a list of 78
others; however, there are well-established protocols accreditation bodies, each of which accredits certification
and human ethics committees overseeing research bodies, of which there are hundreds across the globe. The
exact number is unknown.
at universities to make such research possible and 3. Castka, “Management Systems Standards: Diffusion,
safe. Studies that were funded by the Joint Accred- Impact and Governance of ISO 9000, ISO 14000, and Other
itation System of Australia and New Zealand4 or in Management Systems Standards,” see reference 1.
4. Pavel Castka, “Audit and Certification: What Do Users
collaboration with auditing firms5 are a few examples. Expect?” technical report, Joint Accreditation System of
Management systems standards are too import- Australia and New Zealand, 2013.
ant not to study them further. We must go beyond 5. Jodi L. Short, Michael W. Toffel and Andrea R. Hugill,
“Monitoring Global Supply Chains,” Strategic Management
the binary logic of certified and noncertified orga- Journal, Vol. 37, 2016, pp. 1,878-1,897.
nizations and find a more fine-tuned approach

Pavel Castka is professor of


operations management at Charles J. Corbett is the IBM chair
University of Canterbury in in management and professor
Christchurch, New Zealand. of operations management and
He holds a doctorate in design sustainability at the University of
and process engineering from California, Los Angeles. He holds a
Brno University of Technology, doctorate in operations management
the Czech Republic. from INSEAD in Fontainebleau, France.

qualityprogress.com ❘ January 2018 QP 37


F E AT U R E
QUALITY TOOLS

Make the most of the product development process


by combining quality function deployment and
design thinking | by Patrícia Moura e Sá

Just the Organizations put considerable effort Among those, quality function deployment
Facts into developing innovative products and (QFD) and design thinking (DT) are partic-
services capable of delivering value to ularly relevant. Possible connections and
Quality function customers and users. Reducing devel- overlaps are explored between QFD and
deployment (QFD) opment costs and the risks of failure, and DT by looking at their core principles, main
and design think-
ing (DT) are used improving time-to-market performance are stages and associated tools.
to help organiza- key priorities.
tions understand
customer needs Acknowledging that customers don’t What is QFD?
when developing buy product or service features but rather QFD is a method used for translating
new products and
services. the functionalities and benefits associated customer requirements into appropriate
with them, organizations constantly look for technical requirements across each stage of
QFD trans-
forms customer methods and approaches to assist them in product development.1, 2 Everything starts
requirements understanding customer needs and prob- with the voice of the customer (VOC), and
into technical
requirements lems. The existence of problems calls for the product specifications are derived from cus-
for a product, creation of multidisciplinary teams and the tomer needs rather than the feelings of the
and DT combines
customer insights early incorporation of user feedback. organization’s technicians or marketers.
and proto- A wide range of methods and tools have The idea of emphasizing customers’ needs
typing to find
solutions to com- been developed to guide the design of new and wants as they are expressed prevents
plex problems. solutions with the purpose of making the the product development team from jumping
process as effective and efficient as possible. to conclusions about what customers are

38 QP January 2018 ❘ qualityprogress.com


looking for in the new product. Therefore,
considerable effort is put into collecting the
VOC, usually through qualitative methods,
such as non-structured interviews and other
observational techniques. QFD recognizes
the importance of observing customers in
their own environment, known as diving into
the aquarium.
To ensure that the VOC guides the entire
process and that decisions about the new
product or service are consistent and
adequately deployed, a series of different
matrixes is used throughout QFD. The house
of quality (HoQ) is the central matrix of the
QFD method. It helps translate requirements
into product, service or process specifica-
tions.3 The HoQ simultaneously addresses the
following questions (see Figure 1, p. 40):
++ What does the customer want? (Room 1)
++ What is the relative importance of each

qualityprogress.com ❘ January 2018 QP 39


F E AT U R E
QUALITY TOOLS

customer requirement? (Chimney) aimed at finding effective solutions to complex prob-


++ How can the product or service respond to customer lems.6 DT calls for the application of different learning
requirements? (Room 2) styles at different stages, which combine various
++ How does each product or service feature relate to degrees of concrete experience, abstract conceptualiza-
others? (Room 4) tion, reflective observation and active experimentation.7
By means of a good documentation system, QFD The DT process often is iterative and comprises three
facilitates coordination and communication, highlights main stages:8
interrelationships and creates a common quality focus 1. Inspiration. When a problem or opportunity is identi-
across all functions involved in the process (marketers, fied. Innovation must be based on users’ experiences
designers, engineers and accountants, for example).4 or problems. During this stage, the team must gain
insight into how people use things or experience
What is DT? situations.
DT, on the other hand, has become popular over the 2. Ideation. When ideas are generated and tested. The
past decade and is regarded as an excellent way to be team goes through a process of synthesis during
creative and innovative.5 Designers are expected to which it distils what it learned during stage one into
understand not only the technical aspects of a problem, insights that lead to solutions or opportunities for
but also a wide range of social, economic and psycho- change. It is necessary to make sense of the data col-
logical effects of the proposed design decisions. DT is a lected by framing and reframing it to identify patterns
constructive and experimental approach that incorpo- and focus on what is most important to the customer
rates in-depth consumer insights and rapid prototyping or user.9
The goal is to find a new way to see the problem,
FIGURE 1 which in turn will allow the team to find new solutions.
Value propositions, which describe the tangible ben-

House of quality efits that customers will derive from using a product
or service, are an outcome of this stage and provide
a high-level specification for the design of the new
product or service.
3. Implementation. When innovation moves from the
Importance weight

project room to the market.


Room 4 Five major steps can be identified in these three
Relationships among features
stages (see Figure 2):
Room 2
1. Empathize. Obtain information about users and the
Service features overall situation that must be addressed by getting in
Hows closer contact with them.
2. Define. Characterize a typical user (persona) around
whom the solution is going to be designed.
requirements

Competitive
Customer

3. Ideate. Generate as many ideas or alternatives as


Room 5

analysis
Room 1

Whats

Room 3
Relationship matrix possible.
4. Prototype. Build basic prototypes of the most prom-
ising ideas.
5. Obtain feedback. Learn from users’ reactions to the
Room 6 prototypes.
Technical importance As shown in Figure 2, DT calls for divergent and con-
vergent thinking. Early in the process, divergent thinking
Room 7
is essential for generating many alternative responses,
Features planning including original and unexpected ideas. It requires mak-
ing unforeseen combinations, recognizing links among
remote associates and transforming information into
Room 8 unexpected forms.10 Creativity largely depends on this.
Target values
Yet, later in the process, it’s important to foster con-
vergent thinking, such as the application of conventional

40 QP January 2018 ❘ qualityprogress.com


and logical search, recognition and FIGURE 2

Steps of design thinking


decision-making strategies.11 This leads
to robust solutions after the problem is
properly defined, and the main dimen-
sions of the situation to be addressed are
characterized.
Many techniques and methods are rec- Obtain
Empathize Define Ideate Prototype feedback
ommended when carrying out DT projects.
Some of the most popular include:
++ Persona profiles. Physical, psychological
and sociological descriptions, for exam-
ple, of potential users based on what was
observed during the inspiration stage. Divergent thinking Convergent thinking
++ Storytelling. Stories put ideas into
context and give them meaning, and nar- Source: Tim Brown, Change by Design, HarperCollins e-books, 2009.
ratives help create multiple touchpoints
along a user’s experiential timeline.
++ Customer journey maps. Oriented graphs that technology and data) responsible for making
describe a user’s journey by representing the different interactions.
touchpoints that characterize his or her interaction ++ Role playing. Actors, sample users or designers
with the service. themselves perform a hypothetical service experience.
++ Experience blueprints. Multidimensional diagrams ++ Mind maps. Visual representations that show multidi-
that build on a user’s persona and journey by layer- rectional connections.
ing elements of the ecosystem (people, processes, ++ Brainstorming. A method for generating many

TA B L E   1

QFD vs. DT
QFD DT
++ Concurrent engineering—some design activities ++ Problem formulation and solution go hand in hand.
View of the design can occur at the same time (parallel). ++ The process is iterative and continual refinement is
process ++ The process is iterative. pursued.
++ Human-centered design ethos.
++ Observational techniques and empathic design.
User-centered ++ Listens to customer needs early in the process. ++ Considers everyone who will be affected by the
design ++ Observes customers in their own environments. product or service, not only the customer or end
user.
++ Interdisciplinary project team works collaboratively.
Nature of the ++ Functional representation—design. ++ Members are expected to have different personality
project team ++ Users might be part of the team. types and backgrounds.
++ Users can be part of the engineering team and
Participation of are at least involved in determining require- ++ Users can be involved throughout the entire
users in the project ments (HoQ R1) and evaluating the project in design process or during certain phases, such as
team comparison to other competitors’ offerings determining requirements and testing.
(HoQ R5).
++ The user typically is the end user.
Focus ++ B2C and B2B projects. ++ Not much emphasis on B2B projects.
++ Except for the earlier stages of VOC collection
Problem-solving where methods are open and creative, the ++ The whole design process calls for creativity, as well
approach process calls for structured and rational as human intuition and emotion.
reasoning.

B2B = business to business HoQ = house of quality R = room


B2C = business to customer QFD = quality function deployment VOC = voice of the customer
DT = design thinking

qualityprogress.com ❘ January 2018 QP 41


F E AT U R E
QUALITY TOOLS

creative ideas in a short period of best described metaphorically as a The nature of the project team in
time. system of spaces rather than a pre- both methods is identical. It should
++ Prototypes. Prototypes facilitate defined series of orderly steps.”12 be diverse to incorporate a wide
communication by making ideas QFD and DT assume that the range of perspectives and improve
tangible and should be as simple design process is iterative, but DT the quality and consistency of
and inexpensive as possible at goes to the point of assuming that decisions. While QFD mentions the
early stages—just enough to problem formulation and solution importance of having cross-func-
obtain useful feedback. inform each other. Also, the idea of tional teams, DT potentially has a
successive refinement is clearer in more open view because it stresses
Comparing DT and QFD DT. the importance of involving peo-
Looking at the way each method Although QFD and DT are both ple with different skills, ways of
regards the design process, the level user-centered design approaches thinking and experiences (inde-
of user involvement, the nature of that value data gathered through pendent of them belonging to a
the project team and the embedded direct observation in close contact department, function or area). Thus,
problem-solving approach, Table 1 with users in their natural setting, DT DT advocates not only functional
(p. 41) summarizes some similarities ranks higher in this regard because it representation but, essentially,
and differences between the two incorporates empathic design. representation of different learning
approaches. Empathic design allows the styles.13
QFD and DT share a view of designer to identify with the chal- Significant differences exist in the
the design process that fights the lenges of the end-user. Though methods’ approaches to problem
traditional step-by-step, sequen- user involvement in testing occurs solving. QFD is considerably more
tial approach. QFD uses the idea in both methods, it is more explicit linear and well-structured. The
of concurrent engineering to call in DT. Similarly, user participation sequence of matrixes calls for a
attention to the importance of in value creation is more passive in logical reasoning often based on
developing some tasks in parallel to QFD (essentially contributing with deductive, causal-effect links. In
speed up the process and integrate opinions about product or service DT, however, the entire innovation
simultaneously the expertise of dif- concepts that were generated by process is deeply human because
ferent functions when making some others), whereas in DT, value is it relies on people's ability to be
decisions. According to author Tim co-created with users more actively intuitive, recognize patterns and
Brown, in DT, “the design process is taking part in the creativity process. construct ideas that have functional

TA B L E   2

Benefits of DT over QFD


DT (+) QFD (−)
++ Understanding how use value is created - Value creation is not explicitly addressed.
is crucial. - Value is regarded as being linked to customer assessment of
++ The value in use perspective is more the product or service characteristics in relation to competitors
Idea of value explicitly captured. (benchmarking).
creation ++ The value is clearly co-created, - User participation in the value creation is more passive
meaning users actively participate in (essentially contributing with opinions about product or service
the act of collective creativity. concepts that were generated by others).
++ There is room for more intuitive - Concept selection follows a logical approach, where alternative
Concept techniques. concepts are rated against a set of criteria based on the product
generation and ++ Extensive use of users’ feedback. or service imperatives.
selection of the ++ A comprehensive approach to test the - Selection is complex and not clearly grounded on users’
winning concept concept with the users is suggested. preferences.
++ Testing is more interactive. - Internal testing procedures assess compatibility among features
++ Prototypes are tested in real-context (HoQ R4).
Testing situations by means of role playing and - Customer evaluates the product or service characteristics in
other techniques. relation to competitors (benchmarking, HoQ R5).

DT = design thinking QFD = quality function deployment


HoQ = house of quality R = room

42 QP January 2018 ❘ qualityprogress.com


TA B L E   3

Benefits of QFD over DT


QFD (+) DT (−)
++ QFD system of matrixes provides a - A set of pictures, graphics and transcriptions are recorded
process for planning and formally and kept, but they are not integrated, and it is difficult to
Documentation system recognizing and managing trade-offs keep track of the path followed to arrive at the solution or
between product or service elements. how decisions were made.
++ The set of matrixes proposed - The DT toolbox is rich until the stage when the value
Guidance on how to go facilitate the process of establishing propositions for the new product or service are identified.
from the prototype to adequate controlling and monitoring - Not much assistance is given on how to guide the
full-scale production or procedures. remaining activities in the innovation process, especially
provision ++ The deployment process promotes on how to conduct the implementation stage.
consistency and alignment.

DT = design thinking
QFD = quality function deployment

and emotional meaning.14 TA B L E   4


Tables 2 and 3 highlight the relative
advantages of each approach over the
other.
Guidelines for a more successful
Application is key product development process
Given the relative advantages of QFD and Stages Core ideas
DT, it is interesting to find ways to com-
++ Include people with different personalities
bine the methods, especially by applying Creating the new and learning styles.
them at different stages of a new product product or service ++ Evaluate whether participation of the end
development team user as a member of the team is feasible and
or service’s development process. Table 4 beneficial.
provides tips on how to combine the two
++ Spend time with users in their natural setting
approaches. to understand problems from their point of
Understanding the users’
In fact, DT offers more guidelines on view.
needs and wants ++ Use observational techniques and collect
how to capture users’ views on the prob- customer voices.
lem to be addressed and, by proposing Establishing the new ++ Use co-creation tools and actively involve
a more comprehensive approach to test product or service value users in the creativity process that leads to
proposition the emergence of the new concept.
with the users the concept to be devel-
oped, makes it easier for an organization ++ Fill out the HoQ.
++ Use the relationship matrix to figure out
to find a way to work together with users whether customer requirements are being
Translating customer
throughout the product or service devel- properly addressed in the new design and
requirements into whether there are opportunities to simplify
opment process. product or service the new product by eliminating features that
features
QFD also is based on a customer empa- do not add value.
++ Analyze synergies and incompatibilities
thy principle, but it tends to overestimate among features in the roof of the HoQ matrix.
the possibility of making the customer an ++ Create simple and inexpensive prototypes.
active member of the QFD team—espe- Testing the new product ++ Ask for users’ feedback in an unstructured
way.
cially when end users are at stake. QFD is or service ++ Have users test the new product or service and
more effective at facilitating the transition observe their behaviors and attitudes.
from prototype to full-scale production or Planning the full-scale ++ Use deployment matrixes to identify and
service provision by taking process and implementation of the design the new operation processes, and
new product or service develop future quality control plans.
control planning a step further. Integrat-
ing QFD deployment matrixes at the later HoQ = house of quality
steps of DT can lead to better results.
Thus, DT is preferably used at the
earlier stages of the development

qualityprogress.com ❘ January 2018 QP 43


F E AT U R E
QUALITY TOOLS

process, especially when interaction with users is critical, expertise and creativity of R&D teams.
whereas QFD is stronger at later stages after the product What can’t be neglected is the importance of putting
or service concept has been chosen and production and ideas to the test to understand how they can be converted
delivery processes must be designed to prepare full-scale into value, as perceived by those who use the products and
implementation. services that result from innovative processes.
QFD can benefit from the lessons given by DT where
REFERENCES
concept and prototype testing is concerned, integrating 1. John R. Hauser and Don Clausing, “The House of Quality,” Harvard
tools that call for user involvement at these critical stages. Business Review, Vol. 66, No. 3, 1988, pp. 63-73.
Innovation demands experimentation, and DT clearly is 2. Damian Rogers and Filippo A. Salustri, “A Quality Function
Deployment Method Pattern Language for Efficient Design,” paper
ahead in this regard. presented at the International Conference on Engineering Design,
Aug. 24-27, 2009.
A word of caution 3. Hauser and Clausing, “The House of Quality,” see reference 1.
4. Anne M. Smith, Moira Fischbacher and Francis A. Wilson, “New
Despite QFD and DT stressing the importance of listening Service Development: From Panoramas to Precision,” European
to users’ needs and expectations when developing new Management Journal, Vol. 35, No. 5, 2007, pp. 370-383.
products and services, it is important to acknowledge some 5. Ulla Johansson-Sköldberg, Jill Woodilla and Mehves Çetinkaya,
“Design Thinking: Past, Present and Possible Futures,” Creativity and
limitations of these approaches. Innovation Management, Vol. 22, No.2, 2013, pp. 121-146.
In fact, users often are inexperienced in imagining and 6. Tim Brown and Jocelyn Wyatt, “Design Thinking for Social
articulating possible innovation for new products and Innovation,” Stanford Social Innovation Review, Winter 2010, pp.
30-35.
services. Even if empathic design tries to overcome these 7. Sara L. Beckman and Michael Barry, “Innovation as a Learning
limitations, sometimes, radical innovations come from the Process: Embedding Design Thinking,” California Management
Review, Vol. 50, No. 1, 2007 pp. 25-56.
8. Tim Brown, Change by Design, HarperCollins
e-books, 2009.
Create the customer-centered culture of excellence. 9. Beckman and Barry, “Innovation as a
Win leadership challenges ignored by LSS, ISO and others. Learning Process: Embedding Design
Make visible the possible you cannot see. Thinking,” see reference 7.
10. Arthur Cropley, “In Praise of Convergent
Inspire, engage, delight and triumph with C3. Thinking,” Creativity Research Journal, Vol. 18,
No. 3, 2006, pp. 391-404.
11. Ibid.

NEW! 12. Tim Brown, “Design Thinking,” Harvard


Business Review, June 2008, pp. 1-10.
13. Beckman and Barry, “Innovation as a
Learning Process: Embedding Design
ü 4th book by best-selling author Thinking,” see reference 7.
and top speaker 14. Brown and Wyatt, “Design Thinking for Social
Innovation,” see reference 6.
ü 5-star ranked at Amazon in
paperback and Kindle

ü Chapters by experts on Baldrige,


ISO, LSS, COQ

ü 20 exercises for leaders and teams

ü Many examples of results

ü Depth with humor

Patrícia Moura e Sá is a professor


at the University of Coimbra in
Workshops, Keynotes, Books, Tools, Mentoring: Portugal, where she teaches
Creating the Customer-Centered Culture quality management and research
Uncovering and Satisfying the Voice of the Customer methods. She earned a doctorate
Project Management When the Solution Is Unknown in quality management in public
Knowledge Product Design and Innovation services from the University of
Process Speed and Simplicity Sheffield Hallam in Sheffield,
England. Moura e Sá is the author
www.C3Excellence.com 941-704-9888 of Qualidade em Ação [Quality in
Action] (Sílabo Editora, 2014).

44 QP January 2018 ❘ qualityprogress.com


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Seeking innovation through tools, techniques and approaches

Innovation mperative
STANDARDS

Whereto After
ISO 9001:2015?
Moving beyond quality management to innovation management

by Peter Merrill

September 2018 is coming fast, require any new work and transition is quite straightforward.
and those who have not transi- That is far from true.
tioned yet to ISO 9001:2015 are To get real value from the new standard, you must link it to your
probably in a last-minute panic. business strategy, as well as the external and internal issues that
Unfortunately, a number of auditors create the context of the organization. The attendant risks are prior-
have given the false impression that itized, and a plan containing measurable objectives is developed to
the new ISO 9001 standard does not mitigate those risks.

FIGURE 1

ISO 50501 Innovation Management System

Plan Do
6 8
Planning Operations

4 5 7
Context Leadership Support
Innovation

10 9
Improvement Performance
Act Check

46 QP January 2018 ❘ qualityprogress.com


That is, of course, only the
beginning.

IMS standard
Interestingly, these are also the first steps
in an innovation strategy, and the ISO Inno-
vation Management System (IMS) standard goes
much deeper into innovation strategy in Clause
5—Leadership.
For those organizations that have already transitioned to
ISO 9001:2015 and have found the true value of the new standard,
there’s good news: The new ISO 50501 Innovation Management is
due for publication at the end of this year, and its structure will fit Clause 4.2—Interested parties gets
perfectly with ISO 9001. you asking who will be your potential
So here is your opportunity to integrate innovation into your busi- customers for future innovative offer-
ness. The plan-do-check-act (PDCA) structure diagram for the IMS is ings. This, of course, relates closely to
shown in Figure 1. opportunities.
These strategic challenges—espe-
Clause 4—Context cially the marketplace challenges—give
Starting with Clause 4—Context, you probably conducted a quality you the fuel for your innovation engine.
management system (QMS) strengths, weaknesses, opportunities Which of your products are declining?
and threats (SWOT) analysis for ISO 9001, and you probably focused Which of your customers are going
on the weaknesses and threats to identify risks in your ISO 9001 quiet? Build your list of threats and
QMS. opportunities in preparation for clause
I’ve heard some people say that they didn’t know why the stan- 6, which—in the innovation stan-
dard mentioned opportunities in Clause 6—Planning. Well, here’s dard—we will reverse the title to call it
why: The opportunities—and also the threats—give you drivers for “opportunity and risk.”
innovation. See Figure 2. Good businesses look for opportunity
first, and then calculate the associated
risk.
FIGURE 2
Clause 5—Leadership
SWOT analysis Before moving to clause 6, however,
clause 5 addresses leadership. I’m
so glad that the term “management
Strengths Weaknesses responsibility” is gone and now replaced
4.1 Identify the
external and internal with the language of business. The inno-
issues relevant to the vation principles in ISO 50501 address
strategic direction the need for leaders who are coura-
of the organization. Opportunities Threats geous and look to the future. Leaders
will certainly be responsible for devel-
SWOT = strengths, weaknesses, opportunities and threats oping a culture of innovation. (More on

qualityprogress.com ❘ January 2018 QP 47


Innovation Imperative

culture in clause 7.) Clause 7—Support


You also will want to build inno- Clause 7—Support is exactly that. It gives you everything you need
vation into your policy statement in to enable innovation. Innovation culture is the No. 1 topic I’m most
clause 5.3, and the leadership clause frequently asked about. People want to know how to develop a cre-
devotes a full subclause 5.4 to innova- ative culture that can co-exist with the execution culture of quality
tion strategy. management.
Clause 5.5 addresses structure, and For instance, they want to know how to allow exploration, collab-
don’t overlook Clause 5.6—Roles and oration and experimentation to thrive. And interestingly enough, an
responsibilities, which is often skipped entire subclause 7.3 is devoted to collaboration. Collaboration is the
through and considered a “given” in key to open the door to disruption.
ISO 9001. We are used to managing the resources of time, money and
Here, you must pause and ask people, but how do we manage knowledge, which is the lifeblood of
yourself how you will structure innovation? This is a short clause in ISO 9001, but it gets a lot more
innovation into your organization. If attention in clause 7.4 of ISO 50501.
this is something new for you, you will Linking closely to this is the need to have an IT infrastructure that
certainly need a core team of change enables the management of knowledge. This got far too little atten-
agents. tion in ISO 9001. Strategic intelligence feeds this knowledge base,
and again an entire clause is devoted to this.
Clause 6—Planning One of the definitions of the innovation process is the conversion
This is where you start to build of new knowledge into new products and services. Those new prod-
traction and where you initiate your ucts and services will have intellectual property (IP) related to them,
innovation portfolio. The portfolio will and this will need protection. IP clause 7.4.3 is in this section, and IP
get much closer attention in clause 8. gets a lot attention.
The output from clause 6 will be the
innovation plan in which you iden- Competence 7.5, Awareness 7.6, Communication 7.7
tify whether you will be addressing Many human resource functions have included “innovation” in their
product, process or business model list of competences for performance assessment, but they are not
innovations. really clear on what they are asking for. In reality, they are usually

FIGURE 3

Change to an innovation management system


Enablers’
resources

Create Core Communicate Critical


People urgency team Recognize
vision mass

Assessment Early Integrate Raise Bigger


Process win win bar win

48 QP January 2018 ❘ qualityprogress.com


FIGURE 4 failing, but don’t be overambitious.

Innovation process
This is familiar territory for a quality
professional. You need a diverse
cross-functional team of people
familiar with the issue you are going
Concept
to address.
solution
ISO 50501 Clause 8.2—Managing
innovation initiatives gives you a
comprehensive checklist of what you
Opportunity Validation
should consider as you plan your
Innovation initiative.
process Clause 8.3 gives you the pro-
cess elements, and you will see it is
similar to the model I have used for
Working many years (see Figure 4). The main
Deployment
solution difference is that I see the innovation
process as a continual cycle, and not
a linear process that starts and stops.
looking for creativity, which is only one of the competences in innova- Similar to the PDCA model, right?
tion. Clause 7.5 provides considerable detail on competences needed.
The awareness and communication clauses are similar to ISO 9001, Clause 8.3.2—Opportunity
but with much more supporting information. Although ISO 9001 does The process starts in clause 8.3.2
not now require a manual, most organizations are continuing to use by identifying opportunities. If you
one, and this is where you can build in your innovation practices as in are choosing to work on a process
the documentation clause 7.8—especially given that many of them will innovation, you will probably start
be new to you. with a gemba walkabout to under-
stand what is and isn’t happening in
Clause 8—Operation the process. If it is a product you are
In Alice’s Adventures in Wonderland, when the white rabbit asked the trying to innovate, you will talk to the
king where to begin its journey, the king replied, “Begin at the begin- customer and ask questions such as,
ning and go on till you come to the end; then stop.” 1 “Where do you waste time?” “What
That is the way we tend to approach standards. I certainly encour- are the biggest hassles?” or “Which
age you to do that in your first read of the standard. When it comes to requirements are unclear or hard to
implementation, however, I suggest a different approach. meet?"
Take a moment to think about change management. Implementing You also should do some process or
innovation management is a major change. The model in Figure 3 is one product benchmarking and find out
I use often. It stresses the importance of initiating change by identifying what other people are doing in your
a burning platform and by a core team getting an early win. area of interest. You should collect a
That early win is going to come here in clause 8 using your innovation large volume of data and information,
process. This is the heart of your IMS. Yes—start drafting your strategy. which you analyze to arrive at a clear
Yes—start planning the culture change. But you will find out what inno- problem definition.
vation is really like right here in the process.
If you have created an ISO 9001:2015 quality manual, I suggest you Clause 8.3.3—Concept solution
create a new working draft “Quality and Innovation Management” This is where you take the knowledge
manual and consider creating a temporary clause 8.9 in the draft from clause 8.3.2 and use techniques
manual. Just call it, “Innovation Process.” ISO 50501 refers to innovation such as creative problem solving
initiatives in clauses 8.1 and 8.2. For the moment, you are going to have (often called ideation) to find concept
just one initiative while you prototype your innovation process. solutions. These are just ideas at this
Settle on a product that is fading or a process that is constantly point. This is where divergent thinking

qualityprogress.com ❘ January 2018 QP 49


Innovation Imperative

creates radical new solutions. Traditional problem solving used in the of the IMS and the management
world of quality finds solutions within the status quo, repairing a broken review, both of which are quite simi-
step in a process or clarifying requirements. Creative problem solving lar to ISO 9001:2015.
finds an entirely new product or process.
Albert Einstein famously said, “No problem can be solved with the Clause 10—Improvement
same level of consciousness that created it.”2 This is where you step After a solution is delivered, there
out of the box. Find many alternatives, and collect and analyze data on is always learning to be gained. The
whether a solution is easy to copy, has high risk, has high cost or will impact may not be that anticipated,
take a long time to implement. and weaknesses and gaps should be
dealt with rapidly. This is where the
Clause 8.3.4—Validate concepts strength of system thinking in an ISO
Now you develop the “proof of concept” and prototype—either virtually management system strikes home.
or in reality—to find the weaknesses of a limited number of preferred The system forces you to take action.
solutions. The innovators’ maxim is “Fail early and fail fast,” and we do My aim here has been to introduce
this before we have incurred significant cost. Analyze the time, cost and you to the structure and thinking
risk data and test whether the solution can be copied. You may choose in ISO 50501 and show you the
to protect the IP you have created, and that was addressed back in opportunity to move beyond quality
clause 7. management to innovation man-
agement. As professed in ASQ’s
Clause 8.3.5—Working solutions Innovation Division, “Innovation is
“Ease of use” is the maxim here. Too often, developers try to add their quality for tomorrow.”
own pet ideas instead of going back to the user needs collected in
REFERENCES
clause 8.3.2. This is where prototyping validates the new service or 1. Lewis Carroll, Alice’s Adventures in
product and not just the concept. Wonderland, Macmillan Publishers
We solidify business partner relationships and mitigate risks. If a International Ltd., 1865.
2. Peter Merrill, Innovation Never Stops,
new offering has been developed for a specific customer, the trials and ASQ Quality Press, 2015.
tests with that customer will uncover areas of difficulty so they can be
removed. Clauses 8.3.3 to 8.3.5 in ISO 50501 will have a lot of align-
ment with clause 8.3 in ISO 9001:2015. I suggest you hold off trying to
mesh them immediately. Learn from this first innovation experience
and understand the process. The ISO 50501 process has a bigger scope
than clause 8.3 in ISO 9001:2015.

Clause 8.3.6—Deploy solutions


I prefer to call this “deliver solutions.” This clause at present misses
some of the important commercial aspects of delivering a solution. The
value proposition is a vital tool. Downstream risks—such as the user
budget cycle—need to be borne in mind. You also switch the conversa-
Peter Merrill is president of Quest
tion from features to benefits at this point. Management Inc., an innovation
consultancy based in Burlington,
Clause 9—Performance evaluation Ontario. Merrill is the author of
several ASQ Quality Press books,
Metrics matter and can be different in the world of innovation—espe- including Innovation Never Stops
cially in the early creative steps. In those early steps, the metrics may be (2015), Do It Right the Second
binary and tend to be subjective. Clause 9 on innovation performance Time, second edition (2009), and
Innovation Generation (2008). He
indicators gives good guidance on the types of indicators that can be is a member of ASQ, previous chair
used—first at the input or creative end of the innovation process, and of the ASQ Innovation Division and
then for throughput when you measure speed and level of engage- current chair of the ASQ Innovation
Think Tank. Merrill is also head of
ment, and finally at output where you measure results. delegation for his country to ISO/TC
This clause does, of course, include the internal audit (or assessment) 279 Innovation Management.

50 QP January 2018 ❘ qualityprogress.com


Solving quality quandaries through statistics

Statistics Spotlight 1213231315447133415341545721157945495241262


124345464755497541275299949514654237204317
91545154134541213231315447133415341545721157945495241262
124345464755497541275299949514654237204317
91545154134541213231315447133415341545721157945495241262
124345464755497541275299949514654237204317
91545154134541213231315447133415341545721157945495241262
124345464755497541275299949514654237204317
91545154134541213231315447133415341545721157945495241262
124345464755497541275299949514654237204317
91545154134541213231315447133415341545721157945495241262
124345464755497541275299949514654237204317
9154515413454

PROCESS CAPABILITY

The Birth of
Specifications by Lynne B. Hare

Reconciling process capability and performance with specifications

Unlike Sandro Botticelli’s God-given. But the origin is defi- the veneration and hesitancy to
depiction of the birth of Venus, nitely the ceiling tile. question.
specifications do not ride in from Why the confusion? Well, Ask around. Find someone
the sea on a half shell. No—they sometimes specifications have who has been in your organiza-
actually come from ceiling tiles. This been around so long that their tion a long time. This might take a
revelation may come as a shock to spanning of generations gives the while, but it can have its rewards.
many who think specifications are appearance of divine origin, hence In moments of candor, he or she

qualityprogress.com ❘ January 2018 QP 51


Statistics Spotlight 1213231315447133415341545721157945495241262
124345464755497541275299949514654237204317
91545154134541213231315447133415341545721157945495241262
124345464755497541275299949514654237204317
91545154134541213231315447133415341545721157945495241262
124345464755497541275299949514654237204317
91545154134541213231315447133415341545721157945495241262

might reveal the nativity. product out the door, so we’d


“Ah, yes. I remember back in Assignable cause variation prefer to have specification limits
’82, they asked me about the is variation due to outside broad enough to drive a truck
specs. My default then was plus interventions, such as raw through—sideways. We know we
or minus 10% around the target. material changes, shift ask embarrassing questions like,
But I had a standby, just in case. changes and changes made ‘Where did these specification lim-
I used the ceiling tile on that one. without the benefit of sup- its come from?’ and ‘What would
My favorite tile was just to the porting data. happen if we were just a touch
left, above my office door. High beyond them?’ After all, rework is
and mighty it was. It revealed expensive and time-consuming.
±8%. The engineers added a deci- May we release slightly out-of-
mal, and the statisticians calculated the probability spec products anyway? If not, may we assimilate
of compliance to four places. That was a proud them with conforming product? Will the custom-
day.” ers really be able to tell the difference?"
That’s a little far-fetched, but make no mistake
about it. To the originator of the specification Modification needed
limits, those bounds serve to protect product and Neither party is wrong. Some moderation is in
process. They cradle the developer’s offspring, the order. But what can be done?
product of their genius, education and experi- First, there should be an assessment of pro-
ence. A violation is a stabbing insult, an affront, an cess capability.1 And the general rule on which all
abuse, a personal attack. should agree is that specifications may never be
Denizens of manufacturing facilities usually set more snugly than process capability will allow.
think otherwise: Have you ever tried to sit in a chair that was too
“Of course, we are corporate citizens, too, so narrow for you? No amount of squirming would
we seek high levels of quality. But we are differ- prevent certain parts of your anatomy from over-
ently motivated. We are often pressured to get lapping the seat. It is the same with specifications
and capability.
Second, specifications shouldn’t come from the
deities or from ceiling tiles. They should be driven
FIGURE 1 by performance factors and by consumer reaction.

Conforming to specifications If you put too much milk in the pudding mix, it
won’t pud. A nut and a bolt won’t conjoin if their
mutual dimensions don’t permit. In many situa-
#3 tions, the establishment of specifications is costly,
requiring careful study and consumer research,
but it is almost always value-added. Performance
Measured key process indicator

as defined by conformance to specifications is the


Capability + structure

#2
key.
#1 Third, and perhaps most importantly, there
Capability

Performance

Target should be congruity of processes and specifi-


cations. This means that at the very least, the
specification limits must be wider than ±3 capabil-
ity standard deviations, as noted earlier.
But things are never quite that simple. There is no
Alternative wiggle room, and we all know that processes wiggle
Intervals derived
specification despite our best efforts to keep them from wander-
from data
situations ing off target. So there should be some allowance
for departures from target. But how much?

52 QP January 2018 ❘ qualityprogress.com


If you have the right kind of long-term data, you the process are necessary for conformance. Situ-
can use them to estimate structural and assign- ation No. 3 illustrates a process that is conforming
able cause variation. 2 to specifications.
Assignable cause variation is variation due A graphical display like this is useful because
to outside interventions, such as raw material it helps R&D and manufacturing staff members
changes, shift changes and changes made without to figure out what must be done to sort out the
benefit of supporting data. specification conundrum.
Structural variation is like assignable cause To be sure, there are other approaches to this
variation, but it is internal to the process and is kind of comparison of process to specifications.
often due to differences among parallel process There are tolerance intervals, which are like having
streams. It appears in the data as a result of the confidence intervals on your intervals. Using them
way the process is structured—hence the name. permits statements such as, “We can be 95% cer-
tain that 99% of the observations will lie between
Capability, structure and cause L and U.”3
The combination of capability, structural and Many use Cp and Cpk as taught in lean Six Sigma
assignable cause variation is performance varia- training.4
tion. It is a measurement of what emerges from A concern with all methods is the possible loss
the end of the manufacturing line. of information resulting from the reduction of
++ If the interval composed of the mean ±3 manufacturing data to a single number or only
capability standard deviations is inside the spec- a few numbers. Excellent statistical software
ification limits, you have some assurance that packages are available to calculate variance com-
the process can meet specifications. ponents, tolerance intervals and quality indexes.
++ If the interval composed of the mean ±3 Most produce images to aid understanding and
“capability plus structural variation standard communication. These images do more than
deviations” is inside specification limits, you words possibly can to ease the reconciliation of
have some assurance that the additional varia- processes and specifications.
tion due to structure is not harmful. If not, there
are adjustment opportunities. REFERENCES
1. Lynne B. Hare, “What’s Meant by Capability,” Quality
++ If the interval composed of the mean ±3 “capa- Progress, August 2014, pp. 50-51.
bility plus structural variation plus assignable 2. Lynne B. Hare, “Chicken Soup for Processes,” Quality
cause variation” is inside the specification limits, Progress, August 2001, pp. 76-79.
3. William Q. Meeker, Gerald J. Hahn and Luis A. Escobar,
you have some assurance that the process is Statistical Intervals, second edition, Wiley & Sons, 2017.
conforming to specifications. If not, there are 4. Lynne B. Hare, “The Ubiquitous Cpk,” Quality Progress,
some process control opportunities. January 2007, pp. 72-73.
Admittedly, Figure 1 is created without the
artistry of Botticelli. Nonetheless, it is intended to
show three possible specification situations. On
the left of the figure are intervals representing ±3
capability, capability plus structure and perfor-
mance intervals derived from process data. On the
right are hypothetical specification intervals.
In situation No. 1, the process does not have
the capability to conform to the specifications.
Product manufactured on that line will never meet Lynne B. Hare is a statistical consultant.
the desired specifications. Situation No. 2 shows He holds a doctorate in statistics from
the process can meet specifications, but there is Rutgers University in New Brunswick, NJ.
He is past chairman of the ASQ Statistics
something in the internal process structure that Division and a fellow of ASQ and the
prevents conformance. Structural adjustments to American Statistical Association.

qualityprogress.com ❘ January 2018 QP 53


Standards-related developments and activities

Standard Issues
IATF 16949:2016

Troublesome
Transitions
A closer look at two difficult IATF 16949 requirements

by R. Dan Reid

The International Automotive Task Force (IATF) has released information on ++ Resources (see ISO 9001:2015,
the most-cited IATF 16949:2016 clauses during initial audits for organiza- clause 7).
tions transitioning from ISO Technical Specification (TS) 16949:2009. ++ Specifying responsibilities and
One such clause—control of production and service provision—was discussed authorities (power to act, for
in the November 2017 Standard Issues column.1 This month’s column focuses on example) (see ISO 9001:2015,
two more clauses generating major nonconformances in IATF 16949 transition subclause 5.3.1).
audits: internal auditor competency and total productive maintenance (TPM). ++ Addressing risks and oppor-
tunities (see ISO 9001:2015,
Internal auditor competency clauses 6.1 and 10.3).
IATF 16949:2016, Subclause 7.2.3—Internal auditor competency generated ++ Process evaluation and update,
the most major nonconformances in the transition audits performed through as needed (see ISO 9001:2015,
August 2017. Internal auditors often missed nonconformances in the quality subclauses 9.1.1 and 9.1.3).
management systems (QMS) they were auditing with alarming regularity, which ++ Process and QMS improve-
may have contributed to the number of findings against this clause so far. ments (see ISO 9001:2015,
This may be due to a misunderstanding regarding what processes internal clause 10.3).3
auditors can audit while remaining impartial. Auditors must have competency To meet the intent of the
to audit the processes assigned to them, which often means they must audit requirements, processes must
their own function or department. Purchasing people likely aren’t competent to be documented to indicate the
effectively audit engineering and some other functions. The standard for audi- inputs, outputs and sequence of
tor impartiality is that auditors must not audit their own work, but they should the process steps. This is referred
be able to audit their own function. to as the process approach. The
Under the new standard, auditors must examine the following aspects of International Accreditation Forum
each QMS process as required by ISO 9001:2015, clause 4.4:2 has communicated to its certifi-
++ Inputs. cation bodies that the use of the
++ Outputs (intended results or intended outcomes). process approach is one of the
++ Sequence of processes. most important requirements for
++ Interactions between processes. a QMS.
++ Process metrics. Further, the IATF added new
++ Process controls (see ISO 9001:2015, subclause 8.5.1). requirements for internal and

54 QP January 2018 ❘ qualityprogress.com


call a nonconformity an opportu-
nity for improvement (OFI). ISO
9000, subclause 3.6.9 defines
nonconformity as “non-fulfillment
of a requirement.”4 An OFI is a
conformity, but one that could
be more effective or efficient.
Organizations now must assess
the competency of their auditors,
address any gaps and retain
documented information, such
as records, as evidence of their
auditors’ competence to avoid
audit nonconformances.

TPM
Another new requirement under
IATF 16949, outlined in subclause
8.5.1.5, is for an organization to
maintain a “documented total
preventive maintenance system.”
This is different from the typical
requirement of a documented
process or procedure. This differ-
ence in clause terminology could
be causing some confusion in the
transition audits. Further, because
this is a new requirement, main-
tenance employees may not be
familiar with writing effective pro-
cess documentation to address
the new requirements.
An IATF 16949-compliant
TPM system must include the
second-party auditor competency by incorporating the process approach, following:
among other things. Under IATF 16949, a documented process must be used 1. Identification of appropriate
to verify auditor competency. The auditor competency process must include and adequate process equip-
verification of auditor competency in several specified requirements and skills. ment for quality and capacity.
See Figure 1 (p. 56) for an example of an auditor competency process based 2. Availability of replacement
on the new IATF requirements, including the October 2017 IATF Sanctioned parts (carried over from ISO/
Interpretations that amended the original IATF 16949 auditor competency TS 16949:2009).
requirements. 3. Adequate resources for
ISO 19011 lists principles and personal attributes that are necessary prereq- machine, equipment and facil-
uisites for being an effective auditor. The ISO 19011 auditing principles include ity maintenance.
integrity and fair presentation. IATF is concerned with third-party auditors 4. Packaging and preserving
adhering to these principles and attributes. For example, auditors should not equipment, tooling and gaging

qualityprogress.com ❘ January 2018 QP 55


Standard Issues
FIGURE 1

Sample auditor competency process


Résumé Auditor candidate
Job description

Auditor personal
attributes criteria Attributes met? No End
(ISO 19011)

Yes

QMS auditor? No

Yes

QMS auditor competencies Reject or train


Competencies No
met? and reevaluate
ISO 19011
IATF 16949 Yes

AIAG APQP Auditor To “knowledge


AIAG MSA competency record met” below?
AIAG PPAP
AIAG FMEA
AIAG SPC Process No To “product
auditor? auditor” below?
Risk
AIAG = Automotive Industry
CSRs Yes
Action Group
APQP = advanced product
quality planning
Competencies No
Reject or train CSR = customer-specific
Additional process auditor competencies met? and reevaluate requirement
FMEA = failure mode and effects
Yes analysis
Manufacturing IATF = International Automotive
process knowledge Task Force
Auditor
Process risk competency record ISO = International Organization
analysis for Standardization
Control plan MSA = measurement systems
analysis
Product No To “knowledge PPAP = product part approval
auditor? met” below? process
Additional product auditor competencies QMS = quality management
Yes
system
SPC = statistical process control
Product
requirements
Competencies No
Reject or train
Measurement met? and reevaluate
device use
Yes

Auditor maintenance and improvement Auditor


competency record
Auditing procedure
(minimum number
of audits)
Reject or
Internal Knowledge No train and
requirement changes met? reevaluate
Yes
External changes,
including CSRs
Qualified auditor

56 QP January 2018 ❘ qualityprogress.com


(carried over from ISO/TS 16949:2009).
5. Applicable customer-specific requirements.
6. Documented maintenance objectives (carried over from ISO/TS
16949:2009).
7. Maintenance metrics.
8. Regular review of maintenance plan and objectives. Periodic overhaul may
9. A documented action plan to address corrective actions when not be well understood
objectives are not achieved. by many organizations.
10. Use of preventive maintenance methods.
11. Use of predictive maintenance methods, as applicable (carried over
from ISO/TS 16949:2009). requirements that are difficult to
12. Periodic overhaul.5 successfully implement, such as
This last item—periodic overhaul—may not be well understood by risk, contingency plans, prob-
many organizations. IATF 16949 defines it as a “maintenance meth- lem solving and management
odology to prevent a major unplanned breakdown where, based on review. Look for discussions of
fault or interruption history, a piece of equipment, or subsystem of those requirements in future
the equipment, is proactively taken out of service and disassembled, columns. 
repaired, parts replaced, reassembled, and then returned to service.”6
REFERENCES
This is similar to the ISO/TS 16949:2009 requirements, only more 1. R. Dan Reid, “Navigating Difficult
detailed. Requirements,” Quality Progress,
As for using preventive and predictive maintenance methods (items November 2017, pp. 63-65.
2. International Organization for
10 and 11), ISO/TS 16949:2009 defined predictive maintenance as Standardization (ISO) and the
“activities based on process data aimed at the avoidance of mainte- International Accreditation Forum,
nance problems by prediction of likely failure modes”7 and preventive ISO 9001 Auditing Practices Group
Guidance on Processes, Jan. 13, 2016,
maintenance as “planned action to eliminate causes of equipment https://tinyurl.com/yd6cdeve.
failure and unscheduled interruptions to production, as an output of 3. International Automotive Task Force
the manufacturing process design.”8 Those definitions carry over into (IATF), IATF 16949:2016—Automotive
quality management, Subclause
IATF 16949:2016. 7.2.3—Internal auditor competency.
It may be unclear to maintenance organizations how best to docu- 4. ISO, ISO 9000—Quality management
ment and address these new requirements. Also, ISO/TS 16949:2009 systems—fundamentals and
vocabulary, subclause 3.6.9.
requirements were limited to key equipment, whereas the new 5. IATF, IATF 16949:2016—Automotive
requirements encompass more. QMS practitioners may need to pro- quality management, subclause
vide assistance with this clause going forward. 8.5.1.5.
6. Ibid, subclause 3.1.
Another factor that may apply for auditing TPM system require- 7. ISO, ISO/TS 16949:2009—Quality
ments and other clauses is auditor competency. Many auditors have management systems, subclause
not been responsible for, or worked in, maintenance operations. It is 3.1.8.
8. Ibid, subclause 3.1.7.
unclear whether organizations
or certification bodies require
their auditors to have main-
tenance operation training to
R. Dan Reid is the principal consultant with Management Systems
properly audit IATF 16949. This Consulting LLC in Farmington, MI. He is an author of ISO Technical
concern also applies to other Specification 16949, QS 9000, ISO 9001:2000, ISO IWA-1 (the
IATF 16949 clauses, such as first International Organization for Standardization international
workshop agreement), the Chrysler, Ford, GM Advanced Product
corporate responsibility (sub- Quality Planning With Control Plan, Production Part Approval
clause 5.1.1.1) and purchasing Process and Potential Failure Modes and Effects Analysis manuals.
processes (clause 8.4). Reid was the first delegation leader of the International Automotive
Task Force. He is an ASQ fellow, an ASQ-certified quality engineer and a trainer of
These are just two of many standards, including ISO 13485, AS9100, ISO 14001, ISO 45001 and the German
many other automotive QMS automotive standard VDA 6.3.

qualityprogress.com ❘ January 2018 QP 57


Newly released products and tools

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58 QP January 2018 ❘ qualityprogress.com


DISPLAY SWITCH

Touchscreen
resembles
smartphone
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Ideal for control panels


Curtiss-Wright Industrial has introduced the JC1210, a single-axis paddle joystick that extends
the organization's recently introduced JC1200 family by incorporating latching and overpress
functionalities and offering multiple mounting solutions in a single body. This makes the
joystick controller ideal for use in control panels and armrest assemblies found in material
handling vehicles, industrial trucks, agricultural equipment and construction machinery.
The JC1210 paddle joystick features an additional 10 degrees of travel at both ends of
the axis, which can be specified by machine designers and end users for either latching or
overpress functions to meet system requirements to hold functions at full speed/float.
A soft-touch colored insert area of the paddle increases operator comfort and
decreases the likelihood of finger-slip during operation. The option of paddle overpress
and latch, electrical terminations, output sense, output voltages and paddle soft-
touch colors means the JC1210 paddle joystick offers more than 600 variations.
www.cw-industrialgroup.com | 44-1202-034000

qualityprogress.com ❘ January 2018 QP 59


and leaders, giving readers a sense of Schweppes, Hewlett Packard, Interna-
involvement through a first-person narra- tional Center for Tropical Agriculture,
tive. The authors emphasize strategies for Lloyds Register Marine, NASA, U.K.
people using their knowledge, including National Health Service Digital and the
knowledge they develop or gain from U.S. Army. These examples are formulated
others, to optimize operations. from interviews with personnel in these
Chapter two offers tasks for surveying organizations.
the minefield that can bring problems, The 89 pages of text in the book are
reduction in successes and even failures supported by a 12-page appendix that
to an organization. For many, this will includes exploration of how the authors
be a how-to-do handbook for traveling came to write the book. An 11-page glos-
forward and reaching goals as progress sary is a useful reference while reading
continues through the minefield. the book and as communication about
Navigating the Minefield: A Chapter three presents the idea of managing knowledge, making decisions
Practical KM Companion developing a 15 to 30 second “elevator and building successes is explored.
PATRICIA LEE ENG AND PAUL J. CORNEY ❚ speech” to explain why your knowledge I recommend this book for people
ASQ QUALITY PRESS ❚ 2017 ❚ 140 PP. ❚ $21 management initiative is valuable to your leading and influencing quality programs.
MEMBER ❚ $35 LIST (BOOK) operations and programs. The speech tells It prompts thinking and discussion, and
others the “why” of what you are doing offers insights to tactics that can improve
This is a fascinating read illustrating and helps you put in focus your initiatives. results through effective use of knowl-
innovative approaches to cost savings Examples of knowledge management edge, insights and communication with
and efficiencies from a knowledge sharing and successful decision making are others.
sense. The book is based on interviews presented from organizations including —Jerry Brong, Ellensburg, WA
and structured conversations with experts Airbus, ARUP Laboratories, Cadbury

Additions to your quality library

Footnotes
Musings on Internal Quality Unique to this text is the middle digital rather than human monitoring and
Audits: Having a Greater Impact section which provides wonderful analysis of processes is changing audit-
DUKE OKES ❚ ASQ QUALITY PRESS ❚ 2017 ❚ context to aspects of auditing (includ- ing. For a current perspective on auditing
130 PP. ❚ $14 MEMBER ❚ $24 LIST (BOOK) ing a section on governance) that is not in a nutshell, this is an excellent book.
covered in other books. As a statistician, —I. Elaine Allen, San Francisco, CA
Audits are either performed in-process the inclusion of a discussion of analytics
or after the project or task is completed. and the examination of risk is important.
They are designed to identify errors or This is included later in the appendixes
weaknesses in the process and to detect that list important questions to ask when
problems that might cause an unaccept- planning an audit or evaluating an audit.
able outcome. There are a lot of good examples listed
This book is a compiled set of training in the first appendix, and I wish the book
materials that provide robust methods was substantially longer so that these
for performing an audit after covering examples could be used to illustrate
basic auditing principles and methods. It applications of the techniques discussed
gives new perspectives on the auditing in section one.
process. Also included are appendixes The last chapter on audits in the future
with audit scenarios, and audit planning is interesting but could be an expanded
and risk management auditing questions. section examining whether reliance on

60 QP January 2018 ❘ qualityprogress.com


Essentials of Engineering Leadership and Innovation
PAMELA MCCAULEY ❚ CRC PRESS ❚ 2016 ❚ 234 PP. ❚ $79.95 LIST (BOOK)

This book provides a great perspective on leadership in a profession that is typically


represented by highly technical individuals. Engineers, are educated in the mastering
of sciences and how it could be used to benefit nature and humankind. However, engi-
neers are not typically identified with leadership roles. Often, these roles are filled by
other professions with a focus on personnel and business management.
This book projects leadership in engineering to another level by adding those princi-
ples of project management, human resources, communication and ethics for effective
leadership. It provides the perspective that engineering and management can go
together, and its principles are equally useful to ensure success in an enterprise from a
business perspective.
What I like the most about the book is how the engineering mindset always shows
for the effective leader by means of goals achievement and continuous improvement
against paradigms.
This book is recommended for engineers and technical personnel in management
positions, as well as for entry-level personnel. The included teachings are useful for every
level in an organization where internal and external customers are the key for success. It
would have been great to have more visuals that directly reference project management
and continuous improvement tools proven to be effective from an industrial phsychology
perspective. The author describes some of these, but visuals would have completed the
message for those at the leadership entry level.
—Robert Guzman, Morehead City, NC

The Supply Chain Revolution: Innovative Sourcing and Logistics


for a Fiercely Competitive World
SUMAN SARKAR ❚ AMACOM ❚ 2017 ❚ 240 PP. ❚ $39.95 LIST (BOOK)

This book guides organizations in pursu- warehouses, sales offices, trucks and
ing a supply chain strategy through the ships, and distribution centers. Here the
implementation of four visions. These focus is lowering logistical costs. The
visions are needed for a business to integrated supply chain must have a
sustain its competitive advantage and common information base and mechan-
survival. The author explains and pro- ics in place to share this information
vides examples of successes and failures among all participants. The objective
detailing how organizations can use their goal for this vision is to keep information
supply chain and sourcing to increase processing costs low.
revenue, lower business risk, improve This book shows that pursuing a senior executive leaders must be proac-
profitability and achieve excellence. supply chain strategy provides a great tive rather than reactive with strategies
Strategically, the supply chain is a opportunity for a sustainable compet- to capitalize on the supply chain threats
chain of resources used to support a itive advantage as it encompasses all and opportunities.
product in the marketplace for target logistics activities, customer-supplier The author notes collaborative rela-
customers. This vision helps improve partnerships, new product development tionships should focus on reducing the
margins and product sales. Functionally, and introduction, inventory management uncertainty in operating environments.
the supply chain procures materials and and facilities. In the future, supply chain business
converts them into saleable products. The author points out that it is better processes will need continuous improve-
This vision focuses on lowering costs to rely on the operational excellence ments to achieve and sustain world-class
across the supply chain. The logis- across the supply chain that provides efficient performance status.
tics-transportation vision is the physical value to the customers than to rely only —John J. Lanczycki, Jr.
path of a product. It embraces factories, on cost-cutting. Chief executives and West Springfield, MA

qualityprogress.com ❘ January 2018 QP 61


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62 QP January 2018 ❘ qualityprogress.com


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How Much
A refresher on a quality
tool, concept or method
Is Too
Much?
As far as evils go, is inventory
necessary?

by Gary Kirsch

3. Design changes and market conditions alleviates—and disguises—the pain


can render your inventory obsolete, associated with a number of production
requiring either rework (there goes the problems.
production schedule) or, worse yet, a To maintain this pain relief, more
complete financial write-off. and more inventory is needed. Increas-
Because of their intimate understand- ing tolerance for inventory leads to
ing of and profound desire to eliminate dependency and feelings that reliable
the seven wastes of lean, manufacturing production requires additional large doses
experts at Toyota developed management of inventory. Satisfying the taste for this
tools that are now regarded as the basis drug ultimately results in inventory levels
for lean manufacturing. The quick change- spiraling out of control.
over technique we know as single-minute While this may be a somewhat harsh
exchange of die (SMED) eliminates the analogy, it shows how serious Shingo
need for buffer inventories during long was about the evils of inventory. Most
Do you have too much inventory? Nearly tooling setups. Other familiar examples importantly, he and his associates went
everyone who has studied continuous are poka-yoke (error proofing) and total further than just observing and criticizing
improvement methods recognizes that productive maintenance (TPM). these evils. They took action by creating
inventory is one of the original seven The well-known Toyota industrial engi- processes like SMED, poka-yoke and
wastes of lean (transportation, inventory, neer Shigeo Shingo, referred to by some TPM to address and solve the production
motion, waiting, overproduction, overpro- as the Thomas Edison of Japan, worked problems that lead to dependency on
cessing and defects). on many of these projects and had a lot to excessive inventory.
Some might ask, “Doesn’t inventory say about inventory. To him, any level of Do you struggle with too much inven-
help smooth out those inevitable bumps stock was a serious problem. tory? How do you feel about it? How do
in the production road and keep things you plan to handle it? As a necessary evil,
moving along? Why would anyone con- Necessary evil or an absolute evil that needs to be identi-
sider it a waste?” There are three primary Shingo called out manufacturers, namely fied and eliminated?
reasons: those in North America and Europe,
BIBLIOGRAPHY
1. Although accounting rules may regard for their philosophy that inventory was Shingo, Shigeo, Non-Stock Production: The Shingo
inventory as an asset, it also can be a a necessary evil. He complained that System for Continuous Improvement, CRC
significant liability. Inventory represents organizations paid too much attention Press, 1988.
cash that you are not free to use. It to inventory being necessary and not
restricts you from investing in areas enough attention to it being an evil. He
critical to the growth of your business. was adamant that inventory was a total Gary Kirsch is a
That’s why many financial people prop- evil that needed to be recognized as such project advisor
erly recognize it as a frozen asset. and not as just a minor irritation. at Endeavor
Management
2. Inventory has a negative effect on in Houston. He
your operating efficiency and costs. A habit-forming drug earned a bachelor’s
Transporting, storing, preserving and Shingo even likened inventory to a hab- degree in chemical
engineering from
tracking excess material takes time and it-forming drug. He described it as having Purdue University, and is a member of ASQ
often absorbs a lot of resources. a narcotic effect because it immediately and the Society of Petroleum Engineers.

64 QP January 2018 ❘ qualityprogress.com


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