Full Issue PDF
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COM
BUYING INTO
BLOCKCHAINn
How the revolutionary technology will change
supply chains—and the quality profession
VOLUME 51 | NUMBER 10
• Pharmaceutical GMP
Professional
• Quality Auditor
• Quality Engineer
• Quality Improvement
Associate
• Software Quality
Engineer
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INSIDE
by Nicole Radziwill by Bob Kennedy
October 2018
VOLUME 51 ● NUMBER 10
EXCLUSIVES
at qualityprogress.com
Added Insight
Additional figures to illustrate a
comparison between Deming’s red
bead experiment to red-yellow-
green scorecards, the topic of
this month’s Six Sigma Solutions
column, “The Improvement of
Scorecard Management” (pp.
48-52).
One More to Go
An additional table that
accompanies this month’s Back
to Basics column, “The Right
Questions,” (p. 64).
Back to Basics
Volviendo a los fundamentos en
español.
8 10 45 64
53 Standard Issues
12 Mr. Pareto Head Making sense of different
interpretations of ISO 9001:2015.
53
I’m no stranger to the subject of Bitcoin. My significant other dramatically alter quality, how business gets done and the global
has a minor obsession with compulsively monitoring the erratic workforce. Yet the tangible links to our organizations and jobs
swings within his Bitcoin coffers and talking about the topic remains nebulous. That’s because the full deployment of many
with anyone who will listen. Admittedly, I’ve often tuned out of these technologies is in process or still on the horizon. “Let’s
as he went on and on about the novelty of completing nearly Get Digital,” p. 24, details the major technologies that will influ-
instantaneous monetary transactions, in any currency, via your ence the profession in years to come: cloud computing, big data,
smartphone without the involvement of banks or governments, virtual reality, augmented reality, blockchain, additive manufac-
but when I came across the term used in the context of quality, turing, artificial intelligence, machine learning, Internet Protocol
my ears perked up. Version 6, cyber-physical systems and the internet of things.
Blockchain, the technology that enables Bitcoin transac- There is much to know, and much to do to prepare.
tions, will inevitably revolutionize supply chains of the future, We hope this month’s issue helps bring these new and emerg-
as detailed in this month’s cover story, “The Time Is Now,” p. 18. ing technologies into sharper focus as they
Read about how blockchains work, and how the technology will relate to quality and your future.
solidify the integrity of tomorrow’s supply chains. As the article’s
author maintains, it’s not a matter of “if,” it’s “when.”
ASQ defines the overarching concept of Quality 4.0 as the
“future of quality within the context of the exponential growth
of technological advancement and the unprecedented rate of
change that those advancements are causing.” Seiche Sanders
There’s no arguing that this concept—Quality 4.0—will Editor in Chief and Publisher
TCC Daniella A. Picciotti, QMS Alliance Brady Boggs, Randy Brull, Larry Haugh,
Secretary William J. Troy, ASQ Jim Jaquess, R. Dan Reid, Richard Stump
Directors Technical Reviewers
Donald Brecken Ferris State University Naveen Agarwal, Ashraf Ali, Suresh Anaganti,
Heather Crawford Apollo Endosurgery M. Onur Artan, Andy Barnett, Matthew
Jim Creiman Northrop Grumman Corp. Barsalou, David Bonyuet, David Burger,
Ha C. Dao Emerson Climate Technologies Brooks Carder, Bernie Carpenter, L.N. Prabhu
ASQ’s Vision James Kittredge Adaptimmune US Chandrasekaran, Ken Cogan, Linda Cubalchini-
By making quality a global priority, an Travis, Ahmad Elshennawy, Mark Gavoor,
Scott Moeller GI Supply
organizational imperative and a personal ethic, Kunita Gear, Daniel Gold, T. Gourishankar,
Raul Molteni Molteni Consulting
the American Society for Quality becomes the Roberto Guzman, Ellen Hardy, Lynne Hare,
community for everyone who seeks quality Luis G. Morales Verizon Telematics Inc.
Victoria Jones, Trevor Jordan, Ray Klotz, T.M.
technology, concepts or tools to improve Mark Moyer CAMLS Kubiak, William LaFollette, Scott Laman, Pradip
themselves and their world. Barrie Simpson Genentech Access Solutions Mehta, N.S. Narahari, Arind Parthasarathy,
JoAnn Sternke Pewaukee School District Larry Picciano, Gene Placzkowski, Tony Polito,
ASQ Administration John Vandenbemden Q-Met-Tech Peter Pylipow, Imran Ahmad Rana, Narahari
CEO William J. Troy Allen Wong Abbott Vittal Rao, John Richards, James Rooney,
Senior Leadership Ayman Sakr, Manboubeh Samghabadi, Brian
Administration Scullin, Abhijit Sengupta, Amitava Sengupta,
Ann Jordan Brian Savoie
William J. Troy, CEO Mohit Sharma, A.V. Srinivas, Adrian Tan, Joe
Lindsey Linder Jim Templin Seiche Sanders, Publisher Tunner, B. Vaithiyanathan, Manu Vora, Keith
Chair Elmer Corbin, IBM QP Editorial Review Board Wagoner, Jack Westfall, Doron Zilbershtein
Chair-Elect Benito Flores, Randy Brull, Chair
Universidad De Monterrey Administrative Committee
Past Chair Eric Hayler, BMW Manufacturing To promote discussion of issues in the field of quality and ensure coverage of all responsible points of view, Quality
Treasurer Francisco “Paco” Lopez, Metalsa Progress publishes articles representing conflicting and minority views. Opinions expressed are those of the
authors and not necessarily of ASQ or Quality Progress. Use of the ASQ logo in advertisements does not necessarily
SAC Sylvester (Bud) Newton Jr., Alcoa constitute endorsement of that particular product or service by ASQ.
ADDITIONAL ACTIONS
“Pitfalls and Pratfalls” (September 2018, pp. 42-47) is well
written and addresses important points. One suggestion is to
include the concepts of correction (an interim measure), correc-
tive action (decided based on the root cause analysis to prevent
recurrence) and preventive action. The concept of preventive
action can be elaborated and the fact that corrective action
can’t be a preventive action in all cases must be emphasized.
Sujatha Prakash, Manapakkam, India
native materials. What are some of the pros and cons of reducing
With billions of vendors selling their plastic use? How might these changes affect manufacturers?
items on Amazon, many consumers rely
on reviews to guide their purchasing
decisions. And just one bad review—or no Mike Kuklewski, Netherlands, says: Harry Rowe, Indianapolis, writes:
reviews—can significantly affect a prod- In Belgium and France, a plastics Due to the large variety of types of
uct’s sales. Manufacturers are beginning
recycling organization annually recycles plastics, it can be difficult to separate
to realize that product reviews are a pow-
erful key performance indicator (KPI). more than 50,000 tons of plastics into waste plastic by type. It’s also more
What are some other new or nontradi- reusable granulates. Most of these difficult to return it to a form usable
tional KPIs and what do they measure?
secondary resources are intended for for manufacturing. A lot of recycled
the auto industry. The rest is sold to plastics get turned into things like
organizations providing goods to the plastic decking and park benches.
building and agricultural industries. Some “recycling” plants just burn paper
Join the discussion on myASQ at They export granulate to most Euro- and plastic to generate electricity. The
my.asq.org, or on LinkedIn at www.
pean countries as well as the overseas market for recycled plastics is growing,
linkedin.com/groups/3633.
market. It’s a small drop on the giant largely due to a desire for social respon-
plate of plastics waste, but a fine exam- sibility rather than economics. But it
ple of how industry could create its own isn’t nearly as attractive as recycling
circular economy. aluminum.
What are the In practice, problem solving and RCA are interchangeable.
differences between Technically, problem solving involves assessing a process from end
to end—from the event occurrence to the sustained prevention of
problem solving recurrence. A typical problem-solving approach is the eight disci-
and root cause plines method.
analysis (RCA)? RCA, on the other hand, involves investigating the incident, and
What are some identifying and confirming the root causes. Some organizations also
differentiate between RCA and root cause corrective action, which
tips for effectively involves identifying and confirming the root cause, and implementing
and efficiently corrective actions.
facilitating Here are some of the most important aspects of facilitating prob-
problem solving, lem solving and improvement projects:
During
During the problem-solving process, time management is important, team Reach out to virtual team members
the facilitator should: dynamics are more important for for their feedback and allow all par-
++ Revisit the project scope in every continuity of problem solving, so take ticipants to communicate directly in
meeting and ensure it doesn’t expand. breaks to defuse the situation. case of questions or concerns.
++ Understand the competing priorities ++ Don’t get hung up on a tool’s theoreti-
for resources in the organization cal approach—adapt it to the problem After
and be flexible. For example, ensure at hand. Engage participants by After the problem-solving project,
the timing and duration of meetings making it relevant. Modify five whys the facilitator should work with the
allow participants to perform their analysis from a single causal chain to problem owner and the sponsor to
daily tasks. a multi-branching fault tree analysis, acknowledge the team’s accomplish-
++ Set realistic ground rules for meetings for example. Or, modify cause and ments and communicate successes
(as an input from the team itself) effect diagram labels when analyzing and lessons learned with other
and enforce them. Implement a a software problem. problem-solving teams. Develop and
laptop-down policy, for example, so ++ Keep the use of tools to a minimum nurture the new batch of problem
participants stay focused on dis- and make them simple and easy. solvers—don’t let this become a for-
cussions and participation. Provide Problem solving is about getting gotten skill. And don’t forget to thank
10-minute breaks every hour so results, not a participant showing off management for its support through-
participants can catch up on emails, his or her ability to use complex tools out the process.
make calls and ensure business and analyses.
BIBLIOGRAPHY
continuity. ++ Stay neutral and resist aligning ASQ, “Problem Solving,” asq.org/learn-
++ Solicit input from quiet participants with the authority or influence in about-quality/problem-solving/overview/
by redirecting the conversation the room. Respectfully challenge overview.html.
ASQ, “What Is Root Cause Analysis (RCA)?”
and keeping everyone engaged. assumptions and hypotheses. Ask ASQ, asq.org/learn-about-quality/root-
If a participant is dominating the for data. Make everyone—not just a cause-analysis/overview/overview.html.
conversation, acknowledge his few members—feel important. Ramu, Govind, “Expert Answers: July 2018,”
Quality Progress, July 2018, pp. 8-9.
or her contributions and tactfully ++ Schedule regular meetings with Wikipedia, “Tuckman’s Stages of Group
request that he or she allow others the problem owner outside of the Development,” https://en.wikipedia.org/
to contribute. Use tools such as silent problem-solving activity to discuss wiki/Tuckman%27s_stages_of_group_
development.
brainstorming on sticky notes first to adherence to scope, progress,
get inputs from reluctant participants. escalation to sponsors, questions,
++ Observe participants’ body language concerns about participants’ behav- This response was written by Govind
Ramu, Program Manager, E2E Closed
and anticipate frustration, anger, ior or performance, or the need for Loop Learning, Google, Mountain View,
tiredness and dismissiveness. While additional training, for example. CA.
E-COMMERCE
The
Ratings
Race
The surprising effect of
Amazon reviews
In a world in which millions of brands compete to sell According to Shedletsky, manufacturers are still
similar items, product reviews can be a key decision adjusting to this new reality. “Whereas five years ago,
making factor for consumers trying to decide which they were able to focus on interacting with unhappy
product to buy. Do you choose product A because customers who left reviews on their own websites, now
it’s cheaper but has less favorable reviews? Or, do you they mine the information left by customers on Amazon
buy the more expensive product B with hundreds of for clues,” said Shedletsky.3
positive reviews? As part of her research, Shedletsky interviewed
And perhaps the most trusted and looked to source several industry leaders about this new metric, one
for product reviews is Amazon. So much so, in fact, that of whom was the vice president of operations at a
some organizations have started using the reviews and major cell phone manufacturer. He said: “If you have
ratings as key performance indicators. consistent issues across the reviews, and the company
According to marketing research firm BloomReach, doesn’t respond, this becomes a critical problem for
people trust Amazon reviews so much that they will customers … You can use Amazon reviews to quantify
look at product reviews on the online retailer’s site even how bad quality affects your sales.”4
if they’re going to buy the product somewhere else.1 Despite this news coming to the forefront only
Author Anna-Katrina Shedletsky said the need for recently, a 2006 research paper revealed the same
positive reviews can have detrimental effects. information. Researchers Judith Chevalier and Dina
“Amazon reviews are such a strong driver of sales Mayzlin studied the effect of Amazon book reviews on a
(even for brick and mortar store sales), that a few bad book’s sales. “An increase in the average star rating on
reviews soon after a product ships can have real drag Amazon.com over time results in higher relative sales of
on the sales and resultant revenue for a new product,” the book on Amazon.com over time (one month after
Shedletsky said.2 the reviews under consideration have been posted),”
John Karlin
—powered by Lexis Nexis
according to a new study. The Oceana Canada study, Clinical RN and team leader of Bachelor’s degree in nursing
released this week, looked at 400 seafood samples the therapeutic hypothermia from Oklahoma Panhandle
team in the neonatal intensive State University in Goodwell.
throughout Vancouver, Victoria, Toronto, Halifax and care unit (NICU) at Children’s
Ottawa, and found that 44% wasn't what it appeared to be, Hospital at Oklahoma State
University.
and it was nearly impossible to track from origin to plate.
For more, visit: https://tinyurl.com/ycassckt. What was your jötunn stares you in going somewhere
the face and threatens or doing something.
introduction to to take you down, To be motionless
It’s Cool to Be a Manufacturing quality? stare back and smile, in absolute silence,
improvise, adapt and even if just for a
Engineer Major Again overcome. moment, is golden. A
The number of individuals earning degrees in engineering It started with my glass of wine helps,
internal questioning, too.
has increased steadily over the past decade, and those “Why do we keep Do you have a
numbers will only continue to grow. In particular, one doing things the same
way without trying to mentor who makes Are you active in
subdiscipline of engineering is looking ever more appealing improve anything?” a difference in
to students: manufacturing engineering, which focuses on Frustrated, I thought ASQ?
there must be some your career?
improving the production of an item. Read the full story education or training I currently serve as
here: https://tinyurl.com/y7zj5gcu. on how to do things Susan Bedwell, who chair of the Okla-
better, which led me holds a doctorate of homa City Section.
to lean and Six Sigma, nursing practice, is
10 Things Customer Success and ultimately, ASQ. an advance practice
Leaders Do for Their Clients registered nurse and Have you
the clinical nurse spe- had anything
Customer service means customer success, and as the field Previous note cialist for our NICU.
grows, more leadership roles open up. Customer success worthy jobs? She has always pro- published?
vided me direction,
leaders need strong visionary and management skills, but resources, recommen- A handful of articles,
I worked as an ammu- dations, opportunities
leadership encompasses many vital components to serving nition specialist for and encouragement.
but most recently,
the U.S. Army. It was a “How to Apply 5S:
clients. There are 10 things customer service leaders do for I don’t think I would The Frightening
job many are capable be where I am now
their clients. Read more: https://tinyurl.com/ycep2769. of doing but few without her.
Fridge at Work,”
will do. This was my which appeared
introduction to supply on the website
chain, lot numbers goleansixsigma.com
To get a roundup of the week’s most noteworthy stories Any recent honors in August 2016.
and hazardous mate-
delivered to your inbox every Friday, subscribe to the QNT rials handling. I quickly or awards?
Weekly e-newsletter at asq.org/newsletters. learned that bullets
don’t fly without What was the last
Recently, I received
supply! the Academy of movie you saw?
Neonatal Nursing’s
ISO Excellence in Neona- “Thor” about seven
What’s the best tal Nursing Practice years ago.
New Guidelines Help career advice
you’ve ever
Award.
New guidelines from the International Organization for Many see the world
Be relentlessly per- Wife Carol and two through the lenses of
Standardization (ISO) can help organizations determine how sistent. Don’t let any sons, Antonius and welfare and entitle-
well they recruit new employees. rejections, defeats, Michelozzo. ment. I see the world
ISO/TS 30411:2018—Human resource management—Qual- failures or discourage- through the lenses
ments ever deter you of opportunity and
ity of hire metric includes a range of options to measure the from your pursuits. What are your potential.
quality of a hire, which can be aligned to various business We all face obstacles favorite ways to
and organizational conditions. The document also includes in life. Some of these
obstacles are giants, relax?
international best practices. which we think we
For more on the guidelines, visit www.iso.org/ may not overcome. To just be still and
When a giant or a quiet. I’m constantly
standard/68220.html.
R I S K A N A LY S I S
A Passion for
Pizza—and Risk
Analysis
by Denise Wrestler
How a common tool helped one quality
professional pursue an unlikely dream
I’ve always dreamed of owning my own restaurant. My child- to finally try the amazing pizza we’d been
hood was filled with Play-Doh pizza sets that I would serve to the telling her about.
family dog. I’ve been told my first word was “pepperoni.” Instead, when we pulled up to the restaurant,
Just kidding—I’ve never wanted to own a restaurant. My idea we were greeted by a “Closed for good” sign
of making pizza is opening a box or removing a wrapper, and I’m posted on the window, chains on the doors and
certain my first words were “Document it or it didn’t happen.” (I darkness throughout the empty building.
was a talkative baby.) Our jaws dropped. It was like someone
But it seems like that’s how every dream-come-true story had ripped out our pizza-shaped hearts. My
starts—with a black-and-white flashback to someone’s early begin- six-year-old daughter had huge alligator tears
nings, foreshadowing a master in the making. welling up in her eyes, and my 10 year old was
Then there’s me: I have 15 years of quality and regulatory yelling, red in the face, about to burst into tears.
experience in the medical device field, my husband has 20 years’ Our family was heartbroken.
experience in finance, neither of us have any prior restaurant expe- The “For lease” sign posted in the window
rience—and we’re opening our first pizzeria. and the unpainted trim outline where the
So, how does a couple like us decide to open a pizza restaurant restaurant’s sign once hung were constant
anyway? For the past two and a half years, we’ve wondered the reminders of the deliciousness that used to be
same thing. Why would self-proclaimed sane and financially savvy there. We patiently waited for years, hoping
professionals make such a seemingly ridiculous decision? someone would bring it back to life.
Our story is a roller coaster—one I hope will inspire and excite It wasn’t until passing by that empty space
others to follow their passions and take risks, but only after the for the thousandth time that I came up with
appropriate risk analysis, of course. an idea. I frantically pulled out my cellphone
and called my husband. Our conversation went
Preheat oven to 300 degrees of inspiration something like this:
In December 2013, my mom came to visit me and my family. “Hey honey, you know the Pizza Inn we loved
Between the long sessions of holiday shopping, we decided to that went out of business?”
stop at our favorite local pizza joint, Pizza Inn. My mom was excited “Yeah,” he responded.
Find out how this year’s summit can change your organization.
Register today: asq.org/Quality4.0Summit
F E AT U R E
BLOCKCHAIN
At its very core, a blockchain is like a tra- of the product—from inception to consumption
ditional ledger that keeps records of all the and to eventual redemption. The most inno-
individual transactions made against the prod- vative part about blockchain is its verification
uct. These transactions can occur in any part of system and inherent security.
the supply chain. Blockchain technology has the potential to
The transactions could be any movement change the way we buy and sell things. The
of money, goods or secure data related to the verification and authentication of the product
product—that is, the purchase of raw materials, at every step will impart greater traceability, as
the blending of materials to make a new mate- well as the ability to trust the supply chain. It is
rial, purchase orders to buy new material, quality virtually impossible to change this data with-
inspection, certificate inspection, invoicing and out being detected by other users because no
bank payment. Each of these transactions is one person owns the entire data set. The other
stored digitally as a block within the ledger. great advantage of blockchain is that every
Each of the blocks is timestamped and becomes organization or vendor in this supply chain could
intrinsically linked to one another. The blocks are potentially use a different system, and it does
strung chronologically into a chain—hence the not affect the integrity of the blockchain itself.
term “blockchain.” Consider this scenario that’s relatable to any
To draw an analogy, if each transaction was industry—with a few big assumptions:
a picture, stringing them together and looking Company B wants to buy product X from
at them holistically renders a movie—a history vendor A. Product X has many raw materials,
FIGURE 1
• Supply product X
Procure product X Invoice 2 payment
• Invoice company B Invoice 1
Reference
Quality inspection purchase order:
Number: Quantity:
Inspect quantity: Cost:
Quality Rejected quantity:
Purchase
Invoice 2
order 2
including some base metals that vendor A must base metal to vendor A, its block includes the
source from a global metal distributor. Company sources of the raw material. This information
B issues a purchase order to buy a certain quan- gets tagged to vendor A’s purchase order
tity of product X from vendor A. and, consequently, to company B’s purchase
Because company B is buying this product order as well.
for the first time from vendor A, company B has ++ The metal, along with other raw materials, are
instituted a strict receiving quality inspection processed in vendor A’s plant, and product X
and certificate inspection as part of its process.
After the process and all the raw materials are
verified, including material dimensions, the
quality team accepts the raw materials into its
inventory. Vendor A submits an invoice against A great advantage of blockchain is that
the purchase order. Company B processes the every organization or vendor in this
invoice and submits it to the bank for payment supply chain could potentially use a
to complete the transaction. different system, and it does not affect
As shown in Figure 1, there are various the integrity of the blockchain itself.
transactions involved in this seemingly simple
scenario:
++ The creation of company B’s purchase order
is the first block in this process. The block
itself could have information pertaining to the
quantity of product X, cost and a need-by
date—information gleaned from the purchase
order. This block is timestamped and identi-
fied using a unique identifier. The blockchain
network verifies the veracity of this purchase
order and validates it.
++ Using this purchase order, vendor A sends
its own purchase order to the global metal
distributor, asking for this certain base
material (needed to make product X). This
creates a block inextricably linked to the
previous block (see Figure 2).
++ The global metal distributor buys its
metal from a few foundries around the
world. When it makes that shipment of
is fabricated. All the routings, machining opera- is meant to be used. What if this product
tions and internal quality inspections make it to suffers a metal fatigue failure? The history
product X’s production order, which in turn is tied of product X—including the batch and serial
to company B’s purchase order—thus creating a number of the metal used during produc-
new block. tion—can be identified using its blockchain.
++ Product X shows up in company B’s quality Potentially, other affected products using
inspection department, where the quality depart- the same metal from the same failed batch
ment can verify the entire supply chain, material and serial number can be identified quickly,
certificates, and vendor A’s internal manufactur- thus preventing other failures.
ing documents and quality inspection results. The The simple idea behind blockchain is that
quality department may perform its own quality information becomes part of a chain and
inspection, thus recording the results in another gets its own key, which matches the lock of
block linking it to the purchase order itself. the previous block. If the information in one
++ After product X is received into inventory, vendor block is tampered with, the key and lock
A submits an invoice against the purchase order. will not match anymore, thus effectively
The invoice is compared to the purchase order providing a high level of data security and
and validates whether the quantity and price on fraud prevention.
the invoice match the purchase order, thus creat-
ing another block in this chain. Supply chains and blockchains
You could extrapolate this scenario with prod- Who can forget the horse meat scandal
uct X being shipped to a remote location where it that rocked the United Kingdom in 2013,
when horse meat began to appear in the
beef hamburgers and meatballs sold in
supermarkets? It took weeks before the root
cause of this error was identified. The root
The simple idea behind blockchain cause was based in the labyrinth of Europe’s
is that information becomes part of processed meat supply chain. The meat, in
a chain and gets its own key, which one instance, supposedly traveled from a
matches the lock of the previous block. Romanian slaughterhouse to meat traders
in Cyprus and the Netherlands to a supplier
in France and then to a processing plant
in Luxembourg, thus opening the door for
the integrity of the meat supply chain to be
compromised.
A complex supply chain isn’t—and
shouldn’t necessarily mean—a misman-
aged one. However, a lengthy supply chain
requires a level of oversight that matches
its complexity. With a globalized supply
chain and thousands of components from
various sources going into our products, it is
imperative that we inject a sense of trace-
ability and quality into our supply chain. The
first step to quality lies in knowing where
the parts for our products are being sourced
from.
Of course, as with any technology, there
are downsides:
1. Adopting blockchain as an integral part of
the supply chain is a big departure from
Let’s Get
Digital
The many ways the fourth industrial
Just the revolution is reshaping the way we think
Facts about quality | by Nicole Radziwill
To adapt to
the disruptive
changes brought The technology landscape is richer and more promising
about by the than ever before. In many ways, cloud computing, big
fourth industrial
revolution, a data, virtual reality (VR), augmented reality (AR), block-
new perspective chain, additive manufacturing, artificial intelligence (AI),
on quality is
required. machine learning (ML), Internet Protocol Version 6 (IPv6),
cyber-physical systems and the Internet of Things (IoT)
Organiza-
tions must all represent new frontiers. These technologies can help
leverage Quality improve product and service quality, and organizational
4.0 tools—such
as artificial intel- performance.
ligence, machine In many regions, the internet is now as ubiquitous as
intelligence, per-
vasive computing electricity. Components are relatively cheap. And, a robust
and connectiv- ecosystem of open-source software libraries means that
ity—to improve
their quality and engineers can solve problems 100 times faster than just two
performance. decades ago.
Quality profes- This digital transformation is leading us toward connected
sionals possess intelligent automation: smart, hyperconnected agents
the skills required
to help their deployed in environments where humans and machines
organizations cooperate—and leverage data—to achieve shared goals.
succeed in the
fourth industrial This isn’t the world’s first industrial revolution. In fact, it is its
revolution. fourth—and the disruptive changes it will bring suggest we’ll
need a fresh perspective on quality to adapt to it.
Why now?
Although the growth and expansion of
the internet accelerated innovation in the
late 1990s and 2000s, only now are we In addition, improved network infrastructure is expanding the extent
poised for the fourth industrial revolu- of connectivity, making it more widely available and robust. And unlike
tion. What’s changing? the 1980s and 1990s, there are far fewer communications protocols that
++ Production and availability of are commonly encountered, so it’s a lot easier to get one device to talk
information: More information is to another device on your network.
available because people and devices ++ Intelligent processing: Affordable computing capabilities (and process-
are producing it at greater rates than ing power) are available to analyze and interpret that information so it
ever before. Falling costs of enabling can be incorporated into decision making. High-performance software
technologies, such as sensors and libraries for advanced processing and visualization of data are easy to
actuators, are catalyzing innovation in find and, in many cases, easy to use. In the past, for example, software
these areas. developers had to write their own code for even common tasks. Now,
++ Connectivity: First and foremost, the they can use open-source solutions that are battle tested by many.
introduction of IPv6—which defines ++ New modes of interaction: The ways in which we acquire and interact
how data are sent from one computer with information also are changing. In particular, new interfaces, such
to another—has ensured that there as AR and VR, expand possibilities for training and navigating a hybrid
will be enough addresses to locate the physical-digital environment with greater ease.
billions of devices that are expected to ++ New modes of production: 3-D printing, nanotechnology and gene
connect to the internet. The informa- editing are poised to change the nature and means of production in
tion produced by these devices will be several industries. Technologies for augmenting or enhancing human
instantly accessible over the internet. performance (exoskeletons, brain-computer interfaces and even
autonomous vehicles, for example) also will open new mechanisms for
innovation in production and distribution. New technologies, such as Predictive maintenance can
blockchain, have the potential to change the nature of production as help you anticipate equipment
well by challenging ingrained centralized perceptions of trust, control, failures and proactively reduce
consensus and value creation. downtime. Quality 4.0 initiatives
can help you assess supply
Discovery: The new role of quality chain risk on an ongoing basis,
What we recognize as today’s quality profession began during the middle or help you decide whether to
of the second industrial revolution, with the methods of scientific manage- take corrective action.
ment introduced by Henri Fayol in France and Frederick Winslow Taylor in
the United States. Factories needed methods to ensure assembly lines ran
smoothly so they produced artifacts to specification. Workers could now
know how to engage in the production process and costs were controlled.
As industrial production matured, those methods grew to encompass 3. Improve transparency, traceability and
the design of processes built to produce to specification. In the 1980s and auditability.
1990s, the adoption of personal computing once again changed the land- 4. Anticipate changes, reveal biases
scape. Organizations regrouped their quality efforts around the value of and adapt to new circumstances and
culture and active engagement in quality—and total quality management knowledge.
(TQM), lean and Six Sigma gained in popularity. 5. Evolve relationships, organizational
As connected, intelligent and automated systems are more widely boundaries and concept of trust to
adopted, we can once again expect a renaissance in quality tools and reveal opportunities for continuous
methods. The progression can be summarized through four themes: improvement and new business models.
1. Quality as inspection: In the early days, quality assurance relied 6. Learn how to learn by cultivating self
on inspecting bad quality out of the total items produced. Walter A. awareness and other awareness as
Shewhart’s methods for statistical process control helped operators skills.
determine whether variation was due to random or special causes. Quality 4.0 initiatives might help
2. Quality as design: Inspired by W. Edwards Deming’s recommendation you add intelligence to monitoring and
to cease dependence on inspection, more holistic methods emerged for managing operations, or enable remote
designing quality into processes to prevent quality problems before they monitoring to improve the productivity
occurred. or morale of your operators. Think about
3. Quality as empowerment: TQM and Six Sigma advocate a holistic how to add to human capabilities rather
approach to quality, making it everyone’s responsibility and empowering than how to replace people in your pro-
individuals to contribute to continuous improvement. cesses. According to Finnish sociologist
4. Quality as discovery: In an adaptive, intelligent environment, quality Esko Kilpi, “The real future of work is not
depends on how quickly we can discover and aggregate new data sources, in the industrial model of pursuit automa-
how effectively we can discover root causes and how well we can discover tion but in the post-industrial model of
new insights about ourselves, our products and our organizations. promoting augmentation.”4
Predictive maintenance can help
Quality 4.0 value propositions you anticipate equipment failures and
How can Quality 4.0 help your organization? Specifically, how can you proactively reduce downtime. Quality
improve the performance of your people, projects and products by imple- 4.0 initiatives can help you assess supply
menting enabling technologies such as AI, ML, robotic process automation chain risk on an ongoing basis, or help
and blockchain? you decide whether to take corrective
New technology always should be introduced with a clear articulation action. Quality 4.0 initiatives also can
of its desired benefits. A value proposition is a statement that explains help you improve cybersecurity: docu-
what benefits a product or activity will deliver and, sometimes, how it will menting and benchmarking processes
happen. Value propositions for Quality 4.0 initiatives fall into six categories, can help your organization detect
with No. 1 being the most significant: anomalies and understand expected
1. Augment (or improve upon) human intelligence. performance to more effectively flag
2. Increase the speed and quality of decision making. potential attacks.
The ecosystem of
neural network that incorporates layers with special functions.
AI and ML are becoming popular now because not only is the software
more accessible and easier to apply, but it’s also easier to access the big
Machine learning, sometimes referred to as deep learning, is gaining more attention these days.
As a part of the field of artificial intelligence (AI), machine learning deals with algorithms that make
computers think—that is, make sense of huge amounts of unstructured data by themselves.
Similar to the human brain, these machines are trying to find patterns in data. Or, in statistical
terms, they perform a principal component analysis to distinguish between factors that can help
explain a phenomenon and those that cannot. Machine learning is already an integral part of many
applications used every day, from Facebook’s facial recognition algorithms identifying untagged
faces to Google’s search algorithms refining the user’s search by looking at patterns in that individu-
al’s previous searches.
Machine learning will only become more ubiquitous in the near future. It is, in fact, set to revolu-
tionize the way we live. Tesla’s recent advances with self-driving cars are a perfect example. These
cars automatically guide the passenger through complex and sometimes chaotic traffic situations
by interpreting large amounts of data while driving, enabling the cars to react swiftly to unforeseen
events that appear suddenly. The cars are equipped with hundreds of sensors that feed the com-
puter. Machine learning algorithms enable the cars to learn from the data and get better at handling
complicated situations and predicting their likelihood of occurrence.
Look to the future, and you will not only encounter self-driving cars, buses, trains or planes, but
a wide array of other possible uses of machine learning. Some examples include market research,
strategic controlling, medical analyses and legal services, to name just a few. Each will be concerned
with working through large amounts of data to find the right response.
Will machine learning also affect industrial production? And, most important to us as quality pro-
fessionals, will it improve and maintain design quality and production quality? This article addresses
the likely future impact of machine learning on these two quality dimensions.
Of course, this is a bit like reading tea leaves—the field of AI evolves quickly and with uncertain
outcomes. Nonetheless, we can deduce some of the principal fields of application for quality man-
agement solely from having a correct understanding of what machine learning is and where it can
help us in our field of investigation.
Knowing what machine learning is and how it works, and identi- FIGURE 1
Traditional programming
fying areas in quality management where its application will most
likely have a potentially revolutionary impact, can provide a helpful
Intelligent machines
Since the digital revolution took off in earnest in about 1995, com- Traditional programming
puters have become ubiquitous aides in many daily endeavors.
Traditionally, a computer was viewed as a systematic processing Input (data)
machine, transforming input data into output by using algorithms Computer Output (data)
(that is, programs), which had been designed for this purpose by
Algorithm
humans. Given the data are fed to the computer in a consumable
format, its processing power yields predictable results effectively and
efficiently, vastly outperforming its human counterparts.
Machine learning
With the advent of machine learning, this picture is changing
(see Figure 1). Instead of feeding the computer data and programs Input (data)
and expecting output, the computer is now fed input data as well
Computer Algorithm
as output data to discover a systematic link between them—that
is, a functional algorithm. Machine learning is thus applicable Output (data)
whenever:
++ There are patterns between input and output data—but we
don’t know them. enriches the database and serves as a verifier to the
++ We cannot model the pattern mathematically—otherwise, initial insights. The learning process enables the com-
we would just resort to the familiar method of algorithm puter to progress from individual examples to broader
programming. generalizations—that is, to perform inductive reasoning.
++ We have a large amount of unlabeled or uncategorized data. The incorporation of prior knowledge in the form of
For almost any system collecting and analyzing real data, at training sets—implicating a certain bias of the learning
least one of these three points is relevant: process—is often deemed inevitable for the success
1. Knowledge might not always be explicit, as in the case of routine of learning algorithms by preventing the process from
tasks, such as driving, that cannot easily be broken down into reaching senseless conclusions.2
simple programs. What we described so far is supervised learning—
2. Traditional programming produces rigid codes, which do not that is, categorizations of data are given (for example,
adapt to changes over time or to different users. This is something hair length in the facial recognition example) and a
machine learning achieves by adapting to changing input data, training set is provided so the algorithm does not need
such as filtering spam emails and keeping up with constantly to start from zero.
evolving spam techniques. However, a result similar to what is achieved with
3. Large amounts of dynamic data cannot be processed by supervised learning can be done with unsupervised
human-written code because they are simply too complex, as it learning. Here, the algorithm makes sense of all data
is with weather forecasting. purely by itself. No categories or other classifications
The main idea of machine learning is enabling the computer are given, and there is no distinction between train-
to learn by itself, similar to how humans acquire knowledge. In a ing and test data. In July 2017, for example, Google
famous definition, Herbert A. Simon, an American economist and researchers programmed an unsupervised learning
political scientist, pointed out that, “Learning denotes changes algorithm so it could make a humanoid machine
in a system that ... enable a system to do the same task … more advance through difficult territory—one of the most
efficiently the next time.”1 This learning happens without previ- challenging tasks to teach a humanoid because there
ous expertise or access to it. Similar to a human without previous are seemingly unlimited variables involved—solely by
expertise, the computer learns from experience. setting an incentive to overcome obstacles.3
The initial data, which serve as a starting point for the learning Being confronted with a varying set of obstacles,
process, are often referred to as “training data” or “training sets,” such as beams, walls or cliffs positioned in the way, the
and enables the computer to gain some first insight about the algorithm developed the movements needed to tra-
matter at hand. The constant comparison with new incoming data verse the terrain most effectively and efficiently. None
This allows for a better match and an organizations a great deal in achieving This triggers a problem investigation,
optimized feature composition. high design quality by analyzing a richer which usually involves two steps:
Especially in industries in which mass and more complex set of data from the ++ Step one: Finding the quality-
customization is important, machine external environment—whether it be data relevant process parameter (QRP) or
learning can guide organizations in their on customers, trends, competitors or the combination of QRPs that cause
decisions of what product parts to make potential employees—to achieve a much the problem.
customizable and in which form. To use closer match between target customer ++ Step two: Finding the root cause of
the renowned attribute classification of requirements and product features. the parameter deviations.
the Kano model,4 machine learning can Intelligent production quality: The The quality improvement decision
additionally provide an organization with discussion of how machine learning can constitutes the next step:
insights about delight attributes, which help in the other dimension of quality ++ Step three: Making the decision of
can help distinguish the product offer is no less interesting and potentially eliminating the root cause by either
from the competition. game-changing for many industries. optimizing the given technology or
Lastly, on level one, machine learning After the product design decision has adopting a better-suited technology.
also might apply to finding needed techno- been taken, production quality concerns After the defect-causing root cause is
logical or managerial capabilities when—for the question of how well the production cured and the production quality level
strategic reasons, for instance—a certain process is able to turn out products to improves, the follow-up investment is in
customer segment is targeted, but some specifications—in other words, how big quality maintenance. Given the knowl-
of the needed capabilities are unavailable the defect rate is. The lower the defect edge that has been acquired during the
in-house. Finding needed capabilities is no rate, the better the production quality— problem investigation, the logical form of
easy task because they are embedded in with zero defects (or close to zero, such quality maintenance is installing a mon-
human beings. Machine learning, however, as propagated in Six Sigma) meaning itoring system that tracks the identified
might make the search for gifted individ- perfect production quality. Data play an QRPs and indicates looming parameter
uals much more precise because it can important role here. degradations by early warning signals.
infer from a variety of input data (and not Using the quality investment cycle5 To guarantee a permanently high-
only the officially stated facts on résumés for an analytical structure, let’s begin quality level, monitoring must be
or curriculum vitaes) the likelihood that a with recognizing the quality problem—a installed for all QRPs. A main task to
person is able to provide these capabilities. defect rate usually detected by inspec- guarantee high maintenance effec-
In summary, machine learning can help tion or faulty products being returned. tiveness is thus to identify all potential
Training set, predictive function and prediction sometimes dismissed as just hype.
However, there is a compelling logic
transcending the hype: its great power
Training
Training images
of making sense of massive amounts of
Training data, which can help organizations in
labels (names)
their quality management endeavors.
Of course, we should not neglect the
details of implementation, which can be
Facial properties Training challenging. Data from the outside are
not always in a consumable format. There
are security issues to be resolved when
an organization connects its internal sys-
Predictive tems to the external environment. And
function
there is a need for capable AI specialists
Testing who understand where best to apply
Testing image machine learning algorithms and how to
Facial properties Prediction develop them further.
Most importantly, we don’t know what
the future holds. There might be other
challenges impeding the rise of machine this will turn out to be a good investment. 6. Relayr, “IoT Enables Predictive Maintenance,”
http://blog.relayr.io/iot-enables-predictive-
learning, such as limits to the growth in com- In the end, there is no reason not to be maintenance-1, 2017.
puting power or political decisions slowing prepared. 7. Johannes Freiesleben, “Can Six Sigma Claim
the further development of the field. to Be a Generic Strategy? Reassessing
REFERENCES the Competitive Implications of Quality
As with any new technology, early 1. Herbert A. Simon, “Why Should Machines Improvement,” International Journal of Six
adopters can exploit the opportunities Learn?” which appeared in R.S. Michalski, Sigma and Competitive Advantage, Vol. 3, No.
arising from the use of machine learning Jaime G. Carbonell and Toni M. Mitchell, eds., 3, 2007, pp. 248-265.
Machine Learning: An Artificial Intelligence
and gain a possibly decisive competitive Approach. Tioga Pub Co., 1983.
advantage. Machine learning applications 2. Shai Ben-David and Shai Shalev-Shwartz,
could furthermore reinforce the positive Understanding Machine Learning: From
Theory to Algorithms, Cambridge University Johannes
effect on the competitiveness a good Press, 2014. Freiesleben
quality management system already 3. DeepMind.com, “Producing Flexible Behaviors is a professor
entails.7 in Simulated Environments, https://deepmind. of business
com/blog/producing-flexible-behaviours- administration at
Even if organizations are cautious, the simulated-environments, 2017. the University of
way forward should be to start exploring 4. N. Kano, N. Seraku and F. Takahashi, Applied Sciences
machine learning options, determining “Attractive Quality and Must-Be Quality,” St. Gallen in
Journal of the Japanese Society for Quality Switzerland, and focuses on quality
whether there is a potential fit with the Control, Vol. 14, No. 2, 1984, pp. 147-156. economics and the application of machine
organization’s business procedures and 5. Johannes Freiesleben and Gabriele Schwarz, learning in production. He holds a
objectives, and preparing for possible “Quality-Triggered Learning Effects,” Total doctorate in business management from
Quality Management & Business Excellence, the University of St. Gallen in Switzerland.
implementation. With some likelihood, Vol. 17, No. 7, 2006. pp. 825-834. He is a member of ASQ.
21 Century
st
Excellence
Updating the system of profound knowledge for
today’s service systems | by Bob Kennedy
TA B L E 1
Development of SoPK
components over time
SoPK component Component’s development
Appreciation for a system Production viewed as a system, SIPOC, systems thinking
Knowledge of variation SPC, SQC, DoE, Six Sigma
Theory of knowledge PDSA, PDCA
Psychology Teamwork, quality circles, change management, transformation
FIGURE 2
Clients Clients
Excellence
re
re
ltu
ltu
Cu
Cu
Climate Climate
professionals to appreciate and practice this. framework.9 Here again, you must engage with the three
Climate. This is the tangible aspect of an otherwise categories of clients and tease out their appreciation for
intangible culture. Do your best to capture descriptive the context that prevails, and the ability and agility of the
terms, such as professional, efficient, friendly, empa- system to engage, adapt and thrive in it.
thetic, sloppy, gruff and indifferent. What are your Helping a system understand itself requires the skills of a
impressions and perceptions of the system? What is quality professional. After profiling the system, you are in a
your emotional response when engaging with its pro- strong position to reach a fact-based, shared appreciation
cesses? Can you determine how the clients perceive it? for the current system and its behavior.
All systems exist to serve their clients. Therefore, it
might be useful to refer to the five SERVQUAL7 dimen- System transformation and obstacles
sions to capture client expectations and perceptions of If the system’s purpose is unclear or no longer relevant, or
service: if any of the elements (context, clients, culture or climate)
1. Reliability: The system’s ability to perform the prom- are deemed suboptimal, corrective transformation is
ised service dependably and accurately over time. needed. This can’t be imposed on the system. Instead,
2. Assurance: The creators’ knowledge and courtesy, you must engage with the clients, practice excellence and
and their ability to convey trust and confidence. repeat the profiling process to capture their desired future
3. Tangibles: The appearance of physical facilities, system DNA. Here, everything is fluid, dynamic and full of
equipment, personnel and communication materials. possibilities.
4. Empathy: The caring, individualized attention the After the desired future DNA and purpose have been
system provides to its consumers, complementors agreed upon, an HAS will naturally want to rush into action
and internal creators.
5. Responsiveness: Clients’
willingness to help creators, FIGURE 3
Context Context
Complexity
Constraints
Challenge
to function properly? Is it
Conflicts
Clients Clients
re
tu
tu
l
Cu
Cu
Climate Climate
realized, delivered
2. Generative: Depends on the level of uncertainty.
Communication
Quality service
and evaluated
Competition
Context
Complexity
Constraints
3. Social: Depends on clients’ shared assumptions,
Challenge
Clients Conflicts
values, rationales and objectives.12
re
Climate
FIGURE 5
PATTERNS
Straight Line
Or Not?
Extrapolating patterns beyond their natural are two-plus “down” days on the markets, the
show’s stories adopt the tone of “How should an
range can lead to false conclusions investor weather the oncoming storm?”
Not only are these gyrations in tone exhaust-
by Christine M. Anderson-Cook ing, but they also could induce overreactions
to small changes that would lead to poor
Until this spring, I had never heard of the book Factfulness.1 investment actions. The reporting suggests
Then Bill Gates made a big splash in the news by giving each U.S. that a trend of a couple of points in the same
graduate from college a copy.2 In reading the book, I found it to be direction suggests the pattern will continue on
a remarkable combination of hopefulness and commentary about that trajectory for an extended time, when in
some of our blindspots regarding numeracy, and how we interpret fact these chronologically local patterns often
and internalize information in a media-saturated world. are more a reflection of variability and volatility
If you have not read the book, I recommend it highly—not only than they are a trend.
for how it can help us think about the world in a more informed
and balanced way, but also how it analyzes classic mistakes that When is a straight line
we are all prone to. The book describes our instincts to erroneously appropriate?
divide things into groups when distributions are more accurate Beyond the urge to extrapolate based on a
(the gap instinct), misallocate attention to fear-triggering but low small amount of data, there are nuances to the
probability events (the fear instinct), plus eight more. But beyond straight line instinct that are worth exploring
that, Factfulness also presents helpful strategies to tame these more deeply. Factfulness argues that most rela-
debilitating instincts and prevent them from leading us toward tionships are not sensibly described by straight
false conclusions and perceptions. lines, but with functions that curve or include
In this column, I would like to focus on one of these 10 instincts: asymptotes. But this seems to lie in direct
the straight line instinct, which suggests that we often are tempted contradiction to the response surface method-
to extrapolate patterns with straight lines, when these may not be ology3 (RSM) approach of using straight lines
appropriate. Factfulness gives several examples in which incongru- and main effect models to characterize many
ous results are obtained, including one that projects the growth rate types of relationships.
of newborns unaltered through adulthood and reaches outlandish RSM relies on the principle that complex
heights. relationships often can be estimated with
The premise of the straight line instinct is that in the absence of Taylor series approximations—with a first-order
other information, it is natural to extend the pattern that we see with approximation corresponding to a straight line
the obvious straight line. Even in a less-formal way, these extrap- if a single response, Y, is being described by a
olations of trends surround us every day. Each weekday evening, single explanatory factor, X. As the number of
I watch a business show that summarizes stock market trends. If X’s used to describe the response increases, the
there are two-plus “up” days on the markets, the announcers’ stories approximation is defined by a straight plane
all have a jubilant “We are soaring to new heights” flavor. If there or hyperplane. But how can Factfulness and
RSM both be reasonable? There are three key changes in wealth would lead to wild misses in our predictions.
differences to the scenarios considered: changes Hence an important question to ask when looking to generalize a
to the underlying relationships, human reaction relationship and make predictions for new observations is: Are the
and response to observing the patterns, and the underlying drivers of the relationship stable or are there changes
range over which a curve is being used. that might suggest different patterns are appropriate for different
First, Factfulness is almost exclusively subsets of data? Depending on what the answer is, our level of
focused on relationships between inputs and confidence in what we are predicting (particularly in an extrapolated
responses as they change over time, where region) should change.
prediction involves looking into the future. Second, when a system involving people and their actions is being
Response surface methods are predicated on a observed, the rules driving relationships may change in response to
consistent underlying mechanism for all of the the previous pattern. Consider the stock market example, in which
data. If we are modeling a scientific relationship, several days of gains
it is much more likely that the mechanisms driv- on the market might
ing the observed pattern are going to remain lead to investors
The premise of the straight line
consistent for all of the data, and most impor- taking profits, which
instinct is that in the absence of
tantly, for future data. might translate
other information, it is natural to
When we are looking into the future, the into a drop in stock
extend the pattern that we see
underlying rules on which new data will be prices. Relationships
with the obvious straight line.
based are likely to change. In Factfulness, the governed by science
authors consider predicting future population are unlikely to change
growth and note how changes in the affluence with observation. A ball dropped will fall at the same rate whether it
level of the world population drives changes is watched because the rules driving the pattern are not influenced
in people’s behavior. As more of the world by human response. However, when we examine changes in the
moves from subsistence, the average number of world over time—whether economic, global health or climate—the
children they have is reduced. Hence, projecting roles of humans often are changing the nature of these relationships
historical rates of population using a straight line through their intervention. It is critical that we take these impacts
going forward without adjusting for underlying into account as we think about future changes.
Response, Y
values of the explanatory variable. Several
black dashed lines have been added to show
that if we consider smaller ranges of X (shown a
bit offset below the blue line for easier view-
ing), the straight line approximation works well.
When we look across the entire range of X in Explanatory variable, X
the plot, however, a straight line does a terrible Note: A straight line can work well to approximate the (blue)
job of capturing the true pattern of change true curved relationship locally (black dashed lines), but may
poorly misrepresent the global relationship (red line).
and could lead to wild predictions if we tried
to extend beyond the range of observed X
values. RSM actively takes this into account as
models of different complexity are considered people: Look at a plot of the data; by examining a plot of data that
and compared for their ability to characterize generated the blue curve in Figure 1, it is easy to see that a straight
relationships. First order models, models with line is inadequate to summarize the entire relationship.
interactions and second order models pro- Next, it is beneficial to think about what underlying attributes
gressively allow more flexibility to capture the could be changing across the different observations. If we think
patterns that we see in our data. through what might be driving the relationship and see the big
Simple models can be helpful. They allow picture, our ability to select an appropriate model to guide our
us to summarize relationships to see patterns predictions and understanding is vastly improved.
quickly and represent them efficiently. Where So the authors of Factfulness had it right: Straight lines can
we can get into trouble is if the model that we be dangerous and misleading, particularly if the ground rules
use is inadequate to capture the true behavior on which the relationship is based are changing. Hopefully, this
of the system. There are several key ways we has helped clarify when we should be particularly concerned
might be led astray: about building our understanding on such a simplification of the
1. The data on which the model is built come observed pattern.
from several different mechanisms, and
REFERENCES
grouping them together may disguise some 1. Hans Rosling, Anna R. Ronnlund and Ola Rosling, Factfulness: Ten Reasons
of the information we need to understand the We’re Wrong About the World—and Why Things Are Better Than You Think,
patterns we see. Flatiron Books, 2018.
2. Gates Notes on Factfulness, gatesnotes.com/Books/Factfulness.
2. Humans have a way of changing things, and 3. Raymond H. Myers, Douglas C. Montgomery and Christine M. Anderson-
the feedback from seeing or experiencing Cook, Response Surface Methodology: Process and Product Optimization
current patterns often leads to changes in Using Designed Experiments, Wiley-Interscience, 2016.
behavior that will fundamentally change
what future patterns will look like.
3. It is much easier to get a good fit with a
straight line to a local pattern in a relation- Christine M. Anderson-Cook is a research
scientist in the Statistical Sciences Group
ship, compared to looking across the entire at Los Alamos National Laboratory in Los
range of inputs. Alamos, NM. She earned a doctorate in
So how can we keep from being fooled? The statistics from the University of Waterloo
in Ontario, Canada. Anderson-Cook is a
first part of the answer is remarkably simple, fellow of ASQ and the American Statistical
but sometimes eludes even the most sensible of Association. She is the 2018 recipient of the ASQ Shewhart Medal.
The Improvement
Of Scorecard
Management
Comparing Deming’s red bead experiment to red-yellow-green scorecards
TA B L E 1
TA B L E 2
TA B L E 3
Table 3 shows the results of an RYG be the result of natural variation from not perform satisfactorily).
scorecard management metric reporting the process or a special cause event. If a process has an undesirable com-
style. The container of red and white beads mon cause response, the process must
With this RYG scorecard reporting had 20% red beads. For this simplistic be improved. Talking about individual
approach, management again would be situation, we know that the variability out-of-specification occurrences in isola-
reacting to the 12 paddle draws contain- from a paddle draw in this container tion as though they were a special cause
ing 13 or more red bead paddle draws. In should be common cause. In the red is an ineffective management practice.
addition, management would probably bead experiment and RYG situations, the
think that the red occurrence problem management style was to react to any Metric management
was resolved whenever the metric color paddle draw that contained more than 12 with control charts
changed to green on the next draw. red beads as though the situation were A traditional control charting approach
A process output response can either special cause (that is, the operator did separates common cause from special
cause events with the focus on identifying
special cause events so the issue can be
FIGURE 1 resolved in a timely manner. If we consid-
nonconforming report-out
c-chart for this common-special cause
event separation. Online Figure 2 shows a
c-chart for the data in Table 1.
IEE scorecard for data: proportion of red beads in the 50 holes But is the c-chart technically the most
0.35 appropriate chart for this number of red
UCL = 0.3231 beads in a paddle situation? Because
0.30 we know from this process that either a
0.25 white or red bead can be present in any
of the 50 holes, a p-chart that tracks
Rate
X̄ = 9.35
approach to management described as 8
managing of individual occurrences that
6
are not satisfactory relative to a goal.
4
An alternative approach 2
LCL = 2.54
The data in Table 1 will now be reported 1 7 13 19 25 31 37 43 49 55
Paddle draw sequence
out using an Integrated Enterprise Excel-
lence (IEE) 30,000-foot-level metric
The current process is predictable. IEE = Integrated Enterprise Excellence
reporting method.3-12 This form of metric The estimated average number of LCL = lower control limit
reporting consists of two steps: nonconformances is 9.35 per paddle-draw. UCL = upper control limit
X̄ = mean value
1. The process is assessed for stability
from a high-level (30,000-foot-level)
vantage point. greater than 50 red beads for a given nonconformance of 18.7%. If this common
2. If the process is stable, a predictive draw. This approach will mimic cause frequency of nonconformance
process capability statement is made what would be expected as an IEE estimate for paddle draws is unsatisfac-
and reported at the bottom of the 30,000-foot-level report-out if the tory, the process must be improved.
chart with easily understood wording. data were counts of defects from a Counting defects report-out: Figure 2
To illustrate the versatility of this process. shows an IEE 30,000-foot-level report-out
one-page process stability or capability 3. The number of red beads represents when the data are considered counts of
reporting method, Table 1’s data will be a continuous response in which the defects—that is, the number of red beads
reported using the following approaches: goal is to have 12 or fewer red beads in a paddle. From this individuals chart, you
1. Percentage nonconformance in a for every paddle draw—A response would consider this process stable with
paddle draw—With this method, is unsatisfactory if a draw response an estimated average of counts of defects
you understand that each hole in the is greater than 12. This approach will to be 9.35 for individual paddle draws
50-hole paddle can contain either a mimic what would be expected as a from the container. If this common cause
red or white bead after a paddle draw. 30,000-foot-level report-out if the frequency of nonconformance estimate for
This reporting approach will mimic data were examined as a continu- paddle draws is unsatisfactory, the process
what would be expected as an IEE ous response—that is, from another must be improved.
30,000-foot-level report-out when process in which the data were truly a Continuous response report-out:
the data are analyzed as percentage continuous response. Online Figure 4 shows an IEE 30,000-foot-
defective rate. Percentage nonconformance level report-out if the data from Table 1 are
2. Count of the number of red beads report-out: Figure 1 shows an IEE considered continuous. From the indi-
in a paddle draw—Examine the data 30,000-foot-level report-out when the viduals chart on the left side of the figure,
purely from a number of red beads data are considered a nonconformance you would consider this process stable.
in the paddle point of view, in which rate. From this individuals chart of the The probability plot on the right is used to
we will consider in this analysis that, mean, you would consider this pro- determine process capability/performance
technically, there could be a number cess stable with an estimated rate of from a predictability point of view. For an
upper specification of 12, you would expect on how well a process is performing in
that about 17.276% of the time the paddle which common and special cause events
draw values would be above 12. If this com- are separated.
mon cause frequency of nonconformance This process behavioral characteriza-
estimate for paddle draws is unsatisfactory, tion separation is important because the
the process must be improved. actions for special cause can involve the
Deming’s red bead experiment
assessment of individual or group events,
illustrates how attempting to
IEE 30,000-foot-level manage operators and process
while an unsatisfactory common cause
reporting outputs through individual
response suggests that process enhance-
Critiquing individual responses—like ments are needed.
reported values is ineffective.
that done in the red bead experiment With 30,000-foot-level reporting,
and with RYG scorecards—is ineffec- x-bar and R, p-charts, and c-charts
tive management. From this practice, are not used to make a process sta-
treating common cause variability as A 30,000-foot-level report uses an bility assessment. The referenced
though it were special cause can lead individuals chart when making a process 30,000-foot-level articles show math-
to much firefighting, which can be stability assessment. No timely pro- ematically why the individuals chart
costly, frustrating and detrimental to an cess control efforts are attempted with is appropriate for 30,000-foot-level
organization. 30,000-foot-level reporting. This form reporting and other control charting
IEE 30,000-foot-level charting not of performance reporting provides, from techniques are not for this high-level
only assesses process stability from a high-level viewpoint, an assessment form of performance reporting.
a high process vantage point, it also
provides a predictive statement when REFERENCES 30,000-Foot-Level,” Quality Diabetes Measurement
the process is stable. If this predictive 1. Forrest W. Breyfogle III, Progress, November 2006, Tracking at the
statement is unsatisfactory, this process Integrated Enterprise pp. 59-62. 30,000-Foot-Level,” Quality
Excellence Volume II— 7. Forrest W. Breyfogle III, “No Progress, January 2017, pp.
measurement response pulls for the Business Deployment: A Specification? No Problem,” 50-53.
creation and timely completion of a pro- Leaders’ Guide for Going Quality Progress, November 12. Forrest W. Breyfogle III,
cess improvement project to enhance Beyond Lean Six Sigma and 2012, pp. 58-61. Integrated Enterprise
the Balanced Scorecard, 8. Forrest W. Breyfogle, Excellence Volume III—
the performance metric’s response. Citius Publishing, 2008. “30,000-Foot-Level Improvement Project
2. Ibid. Performance Metric Execution: A Management
Control charts are for 3. Forrest W. Breyfogle III, Reporting,” Six Sigma Forum and Black Belt Guide for
“Control Charting at the Magazine, February 2014, Going Beyond Lean Six
controlling processes 30,000-Foot-Level,” Quality pp. 18-32. Sigma and the Balanced
Deming’s red bead experiment illustrates Progress, November 2003, 9. Forrest W. Breyfogle III, Scorecard, Citius Publishing,
how attempting to manage operators pp. 67-70. “Integrating Inputs: A 2008.
4. Forrest W. Breyfogle III,” System to Capture and
and process outputs through individual Control Charting at the React to VOC Data Can Pay NOTE
reported values is ineffective, which can 30,000-Foot-Level, Part 2,” Dividends,” Quality Progress, A no-charge Minitab add-in is
extend to the use of RYG scorecards. Quality Progress, November January 2011, pp. 64-66. available for the easy creation
2004, pp. 85-87. 10. Forrest W. Breyfogle III, of IEE 30,000-foot-level charts
Control charts are used to control pro- 5. Forrest W. Breyfogle III, “High Vantage Point Report- at www.smartersolutions.com
cesses. The identification of special cause “Control Charting at the outs to Reduce Risks of /30000-foot-level-add.
events is to trigger process resolution 30,000-Foot-Level, Part 3,” Organizational Problems,” Organizations can benefit
Quality Progress, November Quality Progress, December when 30,000-foot-level
activities. Control charts are not to make 2005, pp. 66-70. 2015, pp. 58-60. reporting is integrated with the
any statement as to how a process is 6. Forrest W. Breyfogle III, 11. Forrest W. Breyfogle III, processes that created them
performing. “Control Charting at the “Monitor and Manage: using an IEE value chain.
IEE 30,000-foot-level report-outs
provide, from a high-level point of view,
a statement about whether a process
Forrest Breyfogle III is CEO of Smarter Solutions
is stable. In addition, if a process is Inc. in Austin, TX, and holds a master of science
stable and its 30,000-foot-level pro- degree in mechanical engineering from the
cess capability/performance statement University of Texas in Austin. An ASQ fellow,
Breyfogle has authored or co-authored more
is unsatisfactory, the process needs than a dozen business management and process
improvement. improvement books.
Standard Issues
INTERPRETATION PROCESS
Interpretation
“The organization shall” is a well-known phrase found throughout Inter-
national Organization for Standardization (ISO) standards. Its purpose
is to introduce a requirement. What follows these three words must be
addressed by an organization, appropriately implemented and capable of
verification. Unfortunately, sometimes the requirements following a “shall”
phrase can be a bit confusing.
There are countless consultants, fellow standards users, blog sites, books
and articles that can—and often do—provide excellent guidance for mys-
tifying and confusing clause content and terminology. But in the working
committee of the standard itself, there is another opportunity to ask questions annually. The same clause might
about the meaning of a clause: the interpretations process. lead a user to ask whether a
planned interval could be monthly
How it works or quarterly, for example. In both
The U.S. Technical Advisory Group (TAG) to ISO Technical Committee (TC) cases, the answer must be stated
176 (quality management systems) and the U.S. TAG to ISO/TC 207 (envi- as a simple yes or no.
ronmental systems) are two national committees that incorporate a formal ++ The TG22 chair and TAG adminis-
interpretations process into their ongoing activities. trator apportion users’ questions
In the case of U.S. TAG to ISO/TC 176, the U.S. task group on interpreta- to a small subgroup of TAG mem-
tions (TG22) process is documented in a published procedure and available bers who previously volunteered
publicly.1 TG22 employs a formal process that normally requires the following to respond to these questions.
approach (see Figure 1): Their job is to reach out to others
++ The user must submit his or her question via the form attached to the pub- in their networks for further input
lished procedure. before formulating their final posi-
The question must be a request for interpretation, not for information tion—yes or no—and providing the
or explanation, and should seek clarification about what the standard answer to the TG22 chair. If there
requires, not how the requirements could or should be fulfilled or applied. is consensus, the user is provided
There must be a brief narrative posed as a yes/no question, reference to with the TAG’s response.
the appropriate clause and the scenario that gave rise to the question. Lack of consensus is subject to
Interpretations must apply broadly to the entire user community, not just an further discussion in the subgroup
individual organization. to achieve a consensus opinion, or
For example, a user could cite Clause 9.2.1—Internal audit (“The organi- to advise the user that a consen-
zation shall conduct internal audits at planned intervals”2) and ask whether sus was not possible given the
it requires the organization to audit its entire quality management system circumstances. Consensus doesn’t
For reference
Of the many resources used by TG22 Paul Palmes is principal consultant with Business
when rendering interpretations, among Systems Architects Inc. in Fargo, ND, and Prescott,
WI. He is chair of the U.S. Technical Advisory Group
the most helpful are ISO 9000:2015 and to the International Organization for Standardization
ISO/TS 9002:2016. Many of the inter- Technical Committee 176 (ISO/TC 176), and chair
pretation requests submitted to TG22 of ISO/TC 176, subcommittee 1, responsible for ISO
9000:2015.
can be explained by referencing the
definition of terms in ISO 9000:2015—
knowing the proper definition of a key Dale Isaacs is the owner of Brentwood Management
Consulting in Franklin, TN, an industrial and systems
word enables the understanding of a engineer and an ISO 9001 lead auditor. He is the
phrase. Any number of auditors can Secretary of the U.S. Technical Advisory Group to
attest to the difficulties of communi- the International Organization for Standardization
Technical Committee 176 (ISO/TC 176) and chair of
cating with people who simply don’t ISO/TC 176, U.S. TG22, responsible for interpretations
understand a word’s technical definition, for ISO 9001.
A Direct Route
Are you confused about where to begin
with implementing standards within your
organization? Don’t get lost in the woods.
ASQ’s special section can help you start
down the right path. Here you will find:
• Accreditation
• Auditors
• Certification
• Education
• Tools
• Training
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A practical handbook to a robust supplier audit program, soft skills. Readers are given prac-
this book guides readers through the steps to plan and exe- tical advice on several fronts. The
cute an effective risk-based supplier audit. There are several book also contains 25 questions to
handy tools and utilities that the author provides as job guide a risk-based audit from start
aides. Additionally, the many case studies provide practical, to finish.
first-hand scenarios of best practices and lessons learned Effective risk management is at
on topics related to audits, including several of the author’s the heart of any successful business
colleagues across the globe and across multiple industries. environment. This is even more perti-
Part one of the book focuses on end-to-end logistics to nent to global organizations that see
holistically plan, execute, report and close out risk-based more than half of their value-creation occur outside of their
supplier audits. Elements of risk analysis are incorporated in walls. Applying risk-based thinking to supplier management
each of these steps through pointed questions and intro- life cycles is at the heart of this book. This book presents a
spection. For instance, explicitly documenting risks and well-curated collection of methods to perform a supplier audit
hazards in the input, performance and output of a process while keeping risk-management front and center.
being audited. —Anuradha Rangarajan, Harvard, IL
Part two focuses on equipping auditors with a balance of
Footnotes
Mass Customized Manufacturing: Theoretical Concepts and Practical Approaches
VLADIMIR MODRAK ❚ EDITOR ❚ CRC PRESS ❚ 2017 ❚ 332 PP. ❚ $93.95 (BOOK).
In many markets, customers are The first section on trends and success factors provides an
seeking a customized product that overview of designing production lines along with the role of
satisfies their needs. The manu- information systems in mass customization.
facturer who can quickly provide Section two examines the drivers of complexity in sourcing,
customers with the desired product manufacturing and distributing a customized product. This
will continue to capture and expand section is technical in nature and provides several theoretical
market share. This book can be used models that show how complex the manufacturing system and
as a guide for organizations that supply chain may be based on the given inputs.
desire to provide customized prod- The last section addresses sustainability—namely, sustain-
ucts to their customers. ability of the business by understanding consumer trends. The
This book contains 12 chapters divided into three sections section also covers the topic of environmental sustainability.
covering trends and success factors, complexity drivers, and The 12 individual chapters cover a wide range of topics.
management and sustainability of mass customization. Each Readers who are interested in any aspect of mass customiza-
chapter is written by an expert or experts on the given topic. tion will find chapters that address that topic. Readers seeking
Overall, 21 international experts on specific aspects of mass an overview of mass customization also will find many topics of
customization contributed to this book. Each chapter is a interest.
self-contained work on a specific topic, containing a presenta- —Gene Placzkowski, Racine, WI
tion of the material, examples and references.
Senior Management and Quality: How to Leverage Quality for Profit creativity, collaborating with internal and
FIN ROONEY ❚ ASQ QUALITY PRESS ❚ 2018 ❚ 210 PP. ❚ $24 MEMBERS, $40 LIST (BOOK). external partners to drive improvement,
and allowing subordinates and mid-level
What does the word “quality” mean? quality plan is keeping things simple. This employees to own and showcase their
The word might have many definitions strategy of simplicity is one of the ways successes. Owning success means that
to diverse types of people, and they may senior leadership can establish processes those employees must own their pro-
all be correct. What we know to be true, that provide support to the quality of the cesses, any changes to those processes
though, is that there are a few absolutes organization and protect its bottom line. that drive continuous improvement, all
that let us standardize the concept. Good leadership performance metrics and any knowledge
In Rooney’s work, you see connec- also should believe required to understand why the product
tions between the customer experience, in the product as becomes known for its specific level of
production lines, R&D, and leadership much as the team. quality. This total quality approach allows
and management. These workflows can To create a sus- leaders to justify rewarding performance
be continuous, opposing, connected or tainable business that promotes that quality.
simultaneous, but in any case, they all model, leaders In addition to determining quality to
lead to a product that can be rated with must perform or be a consistent strength throughout any
a specific tier of quality. solicit mar- product line, the author reminds readers
Initially the text is as much of a critic ket research and that all departments involved in the value
of the quality profession as a proponent analysis. In a way, stream—which allow the product to be
of it. In the field or in the factory, quality the customers or created—are responsible. From HR and
teams find themselves using a multitude clients within a given market determine talent-sourcing agents for management,
of three-letter acronyms to determine what the word “quality” means. Another to the janitorial staff, which keeps infec-
the quality of a product or service. This market’s customers might have different tious material away from patients at a
alphabet soup can be confusing and expectations and select another product hospital, all team members have a role to
demeaning, which can lead to impasse based upon those norms. play in keeping the customer experience
on the road to knowledge or discovery. Leaders must strategize, support and at the forefront of the quality profession.
One of the keys to executing a solid sell quality. They can do this by fostering —Trevor Jordan, Orlando, FL
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H w
The w w w
A refresher on a quality
tool, concept or method
Right H
w
Questions
Make the most of problem
solving by asking effective
questions
by Ondrej Ďurej
All problem solving begins with a These are excellent questions, but of the problem (symptoms) to its
problem description. One of the best aren’t part of the problem description. essence (primary defect). After the pri-
and most-used methods for describ- They’re part of the problem analysis mary defect is known, the point of origin
ing a problem is five W’s and two H’s, and should be asked later. The right can be determined.
where the questions who, what, where,
when, why, how and how many/how
descriptive questions are:
++ Who detected the problem?
Bullet The point of origin is the answer
to the question, “Where (in which
much are asked. These questions also ++ How is the problem manifested? process) did the problem arise?” It’s
can be used in problem analysis. ++ Why is this a problem? Bullet important to know that quality prob-
People rush to conclusions when The problem was detected by the lems arise only in processes. Therefore,
they intertwine descriptive and ana- problem finder. His or her answer to the point of origin and the root cause
lytical questions. Instead, descriptive the question, “How is the problem can only be found in a process. To find
questions must be asked first, followed manifested?” is called the voice of the the root cause, you also must know
by analytical questions. When the finder. Because operators and quality when the problem arose.
questions are answered, action can be technicians are the best people to Asking who caused the problem
taken to solve the problem. (A sample identify the symptoms of a problem, is common, but the real question is,
action is shown in Online Table 1, which typically they are the problem finders. “Who is accountable?” or “Who is the
can be found on this article’s webpage The answer to the question, “Why process owner?” Although an operator
at www.qualityprogress.com.) is this a problem?” tells you why the can be responsible for the problem,
Answers to the descriptive questions product is unacceptable to the cus- the person accountable always is the
what, where, when and how many/ tomer and thus is called the voice of process owner, who also is responsible
how much typically are easy. You can the customer. Typically, it’s provided by for the solution to the problem.
ask, “What is the problem?” or, “What a quality engineer who, in addition to When looking for the root cause, it’s
product is defective?” identifying the respective symptoms, useful to know the causal mechanism
“Where” questions ask for the point also can express the importance of the or mechanism of origin: “How did the
of detection: “Where was the problem problem. Obviously, there’s a big dif- problem arise?”
detected?” Logically, “when” questions ference between minor symptoms and To improve problem solving, every
ask for the date and time of detection: symptoms that stop production. employee must know: a description,
“When was the problem detected?” When looking for root cause, the analysis and action, and the root cause
The final descriptive questions are, key analytical question is, “Why did is found in a process.
“How many products are defective?” the problem arise?” When you know
or “How much of production (in per- the root cause, you can take corrective
centage) is defective?” action; no other questions are necessary.
These questions and answers are But that’s easier said than done, so
straightforward, but things get tricky problems must be investigated sys-
Ondrej Ďurej is a
when asking who, how and why: tematically, especially if features can freelance consultant for
++ Who caused the problem? be examined for only a limited time. Odecon in Slovakia. He
++ Who is responsible? The essence of a problem often is earned a master’s degree
in electrical engineering
++ How did the problem arise? hidden under several layers, so you must from Slovak Technical
++ Why did the problem arise? proceed from the outward manifestation University in Bratislava.