Anda di halaman 1dari 76


Putting Best Practices to Work | September 2015

The Ishikawa

Family Legacy

p. 46


IS0 9001:2015


ISO 9001:2015
Let our experts help


How to select
an ISO 9001
consultant p. 8
The Global Voice of Quality


Retool audits
using the Kano
model p. 38

p. 18

Statistics can be


Learn the statistics you need to make

data-driven decisions with Quality Trainer,
Minitabs e-learning course. Understand
how to analyze your data and realize the
strength to improve your business.

e-learning for statistics

w w w. q u a l i t y t r a i n e r. c o m

October 27-29, 2015


Only Quality

Donald E. Stephens
Convention Center
Rosemont, IL

Find Quality Answers and

Practical Solutions
Register for FREE today!
The Quality Show is the only tradeshow, for the quality industry, focused exclusively on quality technology,
products, and equipment. Join thousands of quality managers, engineers, corporate executives and
quality manufacturers to find new ideas and solutions to your manufacturing challenges.

The Quality Show Highlights:

Resource-Rich Exhibit Hall Meet with the Industrys premier suppliers demonstrating the latest
products, services and techniques that will improve your business.
Extensive Networking Engage with decision makers and influencers, find new customers and
develop partnerships on the show floor and during two networking receptions.
Free Education Sessions Attend sessions led by American Society for Quality (ASQ), Coordinate
Metrology Society (CMS) and other subject matter experts addressing key issues and quality solutions.
Two high-profile Keynote Presentations Hear from GE Aviation on Strategy, Culture and
Continuous Improvement and NASA on Aerospace Quality Assurance for High Risk Research Payloads
Awards Presentation Join us in honoring these two prestigious awards,
the Company & Plant of the Year, presented by Quality Magazine.



Ends 9/3

Ex cl us i v e l y P r o d u c e d By

Go ld S p o n s o r

Bronze Sponsor

P r o g r a m m i n g Pa r t n e r s

Register for FREE today at

Putting Best Practices to Work | September 2015 |



Keep Calm and Prepare for ISO 9001:2015


A Hard Look at Software Quality

A pilot project proved how the ISO/IEC 25000 family of standards can
be used to evaluate software quality and let developers better address
maintenance issues.

by Moiss Rodrguez, Mario Piattini and Carlos Manuel Fernndez



A new approach that incorporates the Kano model can help you
evaluate the performance of your quality audit programs.


Like Father, Like Son

A look back at the lasting contributions Ichiro Ishikawa and

Kaoru Ishikawa made to total quality management and the
world of quality.

by Gregory H. Watson



ISO 9001:2015


Amazing Audits

by Lance B. Coleman Sr.



Standards experts provide basic analyses and map out five key changes
included in ISO 9001:2015 to help make sense of what they mean, what
your organization must do to meet the new requirements, and resources
available to help you navigate the transition.

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

Allen Gluck, Paul C. Palmes, Denise Robitaille and John E. Jack West



Small Business Challenge

A sidebar for this months

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

More figures to illustrate how

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

Audit Add-Ons

Stay in the Loop

Subscribe to the new Standards

Connection enewsletter and stay
on top of the latest ISO 9001:2015

Back to Basics

Translated into Spanish.

Talk Back

Rate and comment on this months

four feature articles.




Expert Answers


Advice on developing
high-quality suppliers.



Tips on initial ISO 9001

Choosing the right ISO 9001
consultant or registrar.


Quality Progress/ASQ
600 N. Plankinton Ave.
Milwaukee, WI 53203
800-248-1946 414-272-1734

Keeping Current

Dealing with drones.



Mr. Pareto Head

Follow protocol of first initial and full last

name followed by (for example,


QP Toolbox

Article Submissions


QP Reviews

Quality Progress is a peer-reviewed publication with 85% of its feature articles written
by quality professionals. For information
about submitting an article, call Valerie
Ellifson at 800-248-1946 x7373, or email


Up Front

Stress relief.

Measure for Measure

Updates needed to the occupation

classification list.

Quality in the First Person

Learning early on to always do
things rightnot just when others
are watching.


Author Guidelines


Career Corner

In job searches, do your homework

on prospective employers.

To learn more about the manuscript review

process, helpful hints before submitting a
manuscript and QPs 2016 editorial planner,
click on Author Guidelines at www. under Tools and


Statistics Roundtable

Photocopying Authorization


One Good Idea


Including nuisance factors during

Using fault data spectrums
to check corrective actions.

Back to Basics

Are standard certifications always


Authorization to photocopy items for

internal or personal use or the internal or
personal use of specific clients is granted by
Quality Progress provided the fee of $1 per
copy is paid to ASQ or the Copyright Clearance Center, 222 Rosewood Drive, Danvers,
MA 01923, 978-750-8400. Copying for other
purposes requires the express permission
of Quality Progress. For permission, write
Quality Progress, PO Box 3005, Milwaukee,
WI 53201-3005, call 414-272-8575 x7406, fax
414-272-1734 or email

Photocopies, Reprints
And Microform




A new five-step process to evaluate
and balance competing objectives.


How one energy company uses an automotive

standard to assess and manage its suppliers.

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

a personal ethic, the American Society for Quality becomes the community for everyone
who seeks quality technology, concepts or tools to improve themselves and their world.
Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203.
Editorial and advertising offices: 414-272-8575. Periodicals postage paid at Milwaukee, WI, and at additional mailing offices. Institutional
subscriptions are held in the name of a company, corporation, government agency or library. Requests for back issues must be prepaid and
are based on availability: ASQ members $17 per copy; nonmembers $25 per copy. Canadian GST #128717618, Canadian Publications Mail
Agreement #40030175. Canada Post: Return undeliverables to 2835 Kew Drive, Windsor, ON N8T 3B7. Prices are subject to change without
prior notification. 2015 by ASQ. No claim for missing issues will be accepted after three months following the month of publication of the
issue for domestic addresses and six months for Canadian and international addresses.
Postmaster: Please send address changes to the American Society for Quality, PO Box 3005, Milwaukee, WI 53201-3005. Printed in USA.


Article photocopies are available from ASQ

at 800-248-1946. To purchase bulk reprints
(more than 100), contact Barbara Mitrovic at
ASQ, 800-248-1946. For microform, contact
ProQuest Information and Learning, 300 N.
Zeeb Road, Ann Arbor, MI 48106, 800-5210600 x2888, international 734-761-4700,

Membership and Subscriptions

For nearly 70 years, ASQ has been the

worldwide provider of information and learning opportunities related to quality. In addition, ASQ membership offers information,
networking, certification and educational
opportunities to help quality professionals obtain practical solutions to the many
problems they face each day. Subscriptions
to Quality Progress are one of the many
benefits of ASQ membership. To join, call
800-248-1946 or see information and an
application on p. 65.

List Rentals

Orders for ASQs member and nonmember

buyer lists can be purchased by contacting
Michael Costantino at the Infogroup/Edith
Roman List Management Co., 402-836-6626
or fax 845-620-1885.




Stress Relief



Handy primer on the ISO 9001 revision

Mark Edmund

Seiche Sanders


ITS FINALLY HERE: the release of ISO 9001:2015. For months, many have been anx-

Amanda Hankel

iously awaiting this moment and all of the changes that come with it. And though the


wait is over, now the clock starts tickingorganizations have three years to transition
their quality management systems (QMS) to the new edition of the standard.
The transition raises many questions, such as: What is the new clause structure and
why? What does it mean to understand your organizations context? And how does
your QMS address risk-based thinking?
Let us help. QP has been covering the revision process and providing information
to help you prepare all along. With the standards release, we went all out to assemble
the best how-to guide available. In Keep Calm and Prepare for ISO 9001:2015, p.
18, eight key experts weigh in on what you need to know about transitioning to the

Valerie Ellifson

Susan E. Daniels

Tyler Gaskill

Mary Uttech

Sandy Wyss


standard right now. Share this article with your colleagues, teams and bosses. The

Cathy Milquet

standard may just now be final, but this is when the real work begins.


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

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

Barbara Mitrovic


Julie Stroik
Julie Wagner

Naylor LLC
Lou Brandow
Krys DAntonio
Norbert Musial


I was listening to a radio segment this week about Chicagos Air and Water Show
and the newscasters were talking about what you couldnt bring to the lakeside event,
including alcohol and pop-up tents. New to the banned list this year: drones. Drones
have the potential to offer great efficiencies and capabilities to organizations, yet as

Kathy Thomas

Matt Meinholz


businesses wait for approvals, consumer use of drones speeds along, creating dan-

Phone: 414-272-8575
Fax: 414-272-1734

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


California were grounded because of drones flying above the blazes. Numerous pilots

Phone: 866-277-5666

have reported drone sightings within airspace near airports. Regulation seems to be


lagging. Read more about the scary situation in Drone Dilemma (p. 12). QP

William J. Troy


Senior Leadership
Andrew Baines
Michael Barry
Lynelle Korte
Brian J. LeHouillier
Lindsey Linder
Laurel Nelson-Rowe

Seiche Sanders

To promote discussion of issues in the field of quality and

ensure coverage of all responsible points of view, Quality
Progress publishes articles representing conflicting and minority views. Opinions expressed are those of the authors and not
necessarily of ASQ or Quality Progress. Use of the ASQ logo in
advertisements does not necessarily constitute endorsement of
that particular product or service by ASQ.

September 2015 QP

Helping suppliers improve

next year when an auditor finds that one

In response to Back to Basics: Sufficient

clause everyone else overlooked.

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

Tom Fessenden

reer as a computer components software

Putting Best Practices to Work


quality engineer, I developed

and used an audit checklist
to identify risks. This created

Cypress, TX | August 2015


With DoE

p. 20



a profile of the prospective

suppliers strengths and
weaknesses. We then worked
with the chosen supplier to

Person: Substandard Training

ramp up table-side
technology p. 10
Quality and social
cross paths p. 26


strengthen its weaknesses.

Clearing up
In response to Quality in the First

to optimize
innovation p. 14

The Global Voice of Quality

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

description of a (continuing)
misapplication of the idea of


We also put in place incoming

standardization of quality processes.

inspections and testing as contingency

Even now, I am dismayed at the number of

measures to protect our organization

offerings to help people avoid mistakes in

from the suppliers weaknesses.

interpretation of the new version of the ISO

The results from our inspections and

testing were communicated back to the
supplier to further drive its improvement

9001 standard. If the standard isnt selfevidently clear, it isnt written well.
Certification will require agreement

efforts. The supplier, in turn, communi-

with the auditorso if you need any help

cated its testing results to help identify

at all, you should ask the auditor. Indepen-

any test correlation issues.

dent verifications are fine, but I still believe

As our inspection and test data im-

the market is the best indicator of quality

proved, we reduced, then dropped, our

success. If you satisfy the customers (with

incoming inspections. We only monitored

whatever your system is), you will do better

the final system test results and our

than your competition.

customer feedback to verify acceptable

Steven Cooke

quality and reliability. It was a lot of work,

Charlotte, NC

but it resulted in developing low-cost,

high-quality suppliers.

Jargon included

Duane Briggs

In response to Blank-Slate State (May

Lexington, SC

2015, pp. 50-51): This matches my style

exactly when creating a quality management

Plenty still unknown

system. The only thing I do differently is

Open to Change (July 2015, pp. 18-23)

regarding regulatory vomit. I include this

provided good but incomplete information

jargon so the person being audited will not

on an unknown entity (ISO 9001:2015).

be intimidated when the auditor uses it.

The author has provided a little more light

For example, Show me your procedure for

onto the shadowed outline of this critical

product realization.

subject. I dont think we will really know

Rick Paul

what this new revision is until sometime

Escondido, CA


Tune In
The latest episode of ASQ TV dives
deep into root cause analysis, covering how quality tools helped save
a deteriorating national monument
and the benefits of using the scientific method approach. Watch for
two new episodes this month: one
on standards and auditing (Sept. 8)
and another on ISO
9001:2015 certification (Sept. 29). Visit
org to access the
full video library.

Find the latest news, quips and targeted
content from QP staff.

Executive Editor & Associate

Publisher Seiche Sanders:

Associate Editor Mark Edmund:

Assistant Editor Amanda Hankel:
Contributing Editor Tyler Gaskill:





Videos feature ISO 9001:2015 experts

Most of the authors of this months cover story, Keep Calm and Prepare for ISO
9001:2015 (pp. 18-28), appear on ASQs Standards Channel, where they discuss
key changes in ISO 9001:2015 and offer advice for implementing it. Tune in to watch
informational videos at

Dont be a victim

In his Standards Connection enewsletter article, Avoiding Misinterpretation Quicksand,

expert John Guzik clears up potential misunderstandings in the new version of ISO 9001.
Read the article at and subscribe to the enewsletter


Each month at, visitors can take an informal survey. Here are
the numbers from last months Quick Poll:
What is your organizations biggest barrier to creativity?




A hierarchical structure that isnt

conducive to ideas rising up.
Organizational silos prevent collaboration.
Lack of an innovation strategy.
Large team sizes hinder communication.

Visit for the latest question:

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


Recent headlines from ASQs global news service

(All URLs case sensitive)

First 3-D-Printed Drug Approved by FDA

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


Stephen K. Hacker, Transformation Systems

International, LLC


Cecilia Kimberlin, Kimberlin LLC (retired Abbott)


Patricia La Londe, CareFusion


Eric Hayler, BMW Manufacturing


William J. Troy, ASQ

Sue Campbell, ASQ


Donald Brecken, Ferris State University

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


Randy Brull, chair

Administrative Committee

Brady Boggs, Randy Brull, Jane Campanizzi,

Larry Haugh, Jim Jaquess, Gary MacLean,
R. Dan Reid, Richard Stump

Technical Reviewers

Andy Barnett, Matthew Barsalou, David Bonyuet,

David Burger, Bernie Carpenter, L.N. Prabhu
Chandrasekaran, Ken Cogan, Linda Cubalchini-Travis, Ahmad Elshennawy, Mark Gavoor, Kunita Gear,
Daniel Gold, T. Gourishankar, Roberto Guzman,
Ellen Hardy, Lynne Hare, Ray Klotz, Tom Kubiak,
William LaFollette, Pradip Mehta, Larry Picciano,
Gene Placzkowski, Tony Polito, Peter Pylipow,
Imran Ahmad Rana, John Richards, James Rooney,
Brian Scullin, Amitava Sengupta, Mohit Sharma,
A.V. Srinivas, Joe Tunner, Manu Vora, Keith
Wagoner, Jack Westfall, Doron Zilbershtein

enewsletter, available exclusively to ASQ members, delivers it every Friday.
Subscribe now at

September 2015 QP

Business success with ISO 9001

tion. Often, organizations dont account for

Selecting consultants, registrars

Q: If an organization wants to implement ISO

9001 for the first time, what is the first step?

these costs because they are less likely to

Q: What are the qualities to look for when

get caught by a regulatory body. This isnt

selecting an ISO 9001 consultant and

a sustainable business practice, however,


A: Use the organizations purpose as a

because when it comes time to pay for

starting point. Too often, organizations try

one of these expenses, the money needed

A: This question is timely because the

to appease or conquer requirements as

hasnt been accounted for in the budget or

ISO 9001 and ISO 14001 revisions are

if the end-goal is to satisfy those require-

pricing structure.

scheduled to be released in September


After you have accounted for everything

2015. Many organizations planning to

to run your business, think in terms of

use external-expert help in implementing

primary purpose (for example, to make

planning to succeed. Risk-based thinking,

their management systems and that are

money through the product or service

management review and data analysis are

planning to find a registrar to register their

offered or to effectively use the available

great for this because they are intended

management systems will find this answer

resources to promote educational excel-

to help you assess actions already taken

useful. This is an important question

lence) means the organization may create

to determine whether further action is

because choosing the right consultant is

a competition between the requirements,

needed. In essence, the organization is

critical to accomplishing organizational ob-

such as those in ISO 9001, and its organiza-

either already suitably established, ad-

jectives on time and on budget. Choosing

tional purpose.

equately addresses all requirements, and

the right registrar is even more important

is effectively driving behavior, or it has the

because you likely will stay with the same

information and action plan to get there.

registrar for several years to come.

cused on what is important without getting

Q: How should an organization approach ISO

Choosing a consultant

lost in the euphoria of becoming certified to

9001:2015 to make it work for its business?

ISO 10019:2005 defines a quality manage-

Not staying true to the organizations

Using who you are as a business as the

reference point for implementing requirements will help the organization stay fo-

ment system (QMS) consultant as a per-

ISO 9001.
A: Look at the standard through the eyes of

son who assists the organization on QMS

Q: How do you determine what is nec-

the business instead of trying to make the

realization, giving advice or information.1

essary for a business to continue to be

business fit the standard. In other words,

This standard further recommends the

successful in the future? How can ISO

many organizations usually take the stan-

following attributes be considered when

9001:2015 be helpful in doing this?

dard and go through it clause by clause. To

selecting QMS consultants:

see the standard from a business perspective, lay out the organization as it functions,

tributes recommended by the standard,

function as a business (organization) to

and plug in the standards clauses where

being ethical is a key attribute. An unethi-

make money or receive funding today.

they apply to the organization.

cal consultant can cause more damage to

After you understand this, you can evaluate

the true cost of sustaining this.

This may mean a clause is accounted

the organization than an incompetent

for in more than one place in the docu-

consultant. Organizations should check the

mented system. That is actually a good

consultants past projects with clients to

facilities, materials and labor to produce

thing because you are dealing with the

ensure there isnt any unfavorable feedback.

your product or service, dont forget about

organizations reality instead of simply ap-

Other personal attributes to look for include:

less-frequent expenses, such as main-

peasing the standard.

observant, perceptive, versatile, tenacious,

While some costs are obvious, such as

tenance costs, licenses or certifications

required to do business, and any other
costs related to sustaining the organiza-

Ethics. Among the many personal at-

A: Start by considering what it takes to


Robert Freeman
President, Practical Perspectives
McKinney, TX

decisive, self-reliant, communicative, practical, accountable and facilitative.

Experience. The consultant should be

Look at the standard through the eyes of the
business instead of trying to make the business
fit the standard.
able to understand the organizations

knowledge and overall work experience,

organization operates and your customer

context and situation and provide creative

including previous roles in quality and

prefers. Most importantly, your registrar

solutions. This comes from experience

operations management.

should have local auditors who have

in working with different-sized organiza-

solid industry knowledge and experience

tions, in various industry segments and

Choosing a registrar

in addition to proven audit experience.

geographic locations, and on projects with

Organizations do not frequently change

If they must send auditors to you from

varying complexity such as providing low-

registrars, so selecting one requires a care-

other regions and geographies to meet

cost, high-value solutions for resource-

ful review. Knowledgeable customers care

auditor skill requirements, it will cost the

constrained small business clients.

about who issued your QMS certification,

organization hefty travel and administra-

so it is important to consider the registrars

tive expenses year after year.

Education and knowledge. The

consultant should not only have the right

reputation. Reputation of an organization is

level of education, he or she also should

often an indirect measure of the quality of

quality of the registrars audit and the

have the necessary skills to understand

its products and services over time.

value added to the organization.

products and services. They should have

If your organization has several locations

Ask customer references about the

Finally, consider overall audit cost. Ask

knowledge of all the relevant management

in a country or around the world, ensure

for the cost breakdown to understand the

systems standards and other international

that the registrar has branches and a global

typical estimated cost for an audit cycle

standards required to implement the sys-

presence to support your needs. If your

(typically three years). This should include

tem well. Examples include sector-specific,

organization plans to become certified to

details such as the audit fee, annual file

accreditation and product standards, as

additional management systems stan-

maintenance, audit cancellation fee, annual

well as safety-related standards.

dards, such as ISO 14001, OHSAS 18001 or

escalation fee and auditor travel expenses.

The consultant should have expertise

industry standards, ensure that the registrar

The registrar should be responsive to the

or working-level experience in project

carries these certifications and that the

clients needs and provide flexibility with

management and quality management

auditors are qualified to audit to multiple

scheduling audits. It may be a good idea to

principles, methods and techniques.

standards. This will allow you to conduct an

ask the shortlisted registrar to conduct a

Implementing the project may require the

integrated management systems audit with

pre-assessment to verify its capability be-

use of quality engineering tools, statistical

the help of a single registrar.

fore committing to a long-term relationship.

techniques, problem solving, risk management and change management.

Other aspects to consider are industry

The registrars accreditation body also

Govind Ramu

matters. Find out if the accreditation body

Director, quality assurance

is recognized in the regions where your

SunPower Corp.
San Jose, CA


Let QPs subject matter experts help you solve your toughest quality-related
problems. Simply submit your question at, or send it to, and we will find an answer for you.

1. International Organization for Standardization, ISO
10019:2005Guidelines for the selection of quality management system consultants and use of their services.

September 2015 QP
















Our Primers contain study material for the current ASQ bodies of
knowledge plus sample questions and answers. The Primers may be
taken into the exam. The completeness of our materials makes them
the most widely used texts for Certification Training.


Quality Council of Indiana offers detailed solutions to all

questions presented in the corresponding Primer.



QCI offers user-friendly interactive software to assist students preparing

for ASQ examinations. Each CD contains 1000 total questions.
Examinations are timed and summarized graphically. A help file provides
explanations and references. The CDs run on Windows XP and newer.

Mail Orders
Quality Council
of Indiana
Order Department
602 W. Paris Ave.
W. Terre Haute, IN 47885-1124




Fax Orders

Telephone Orders

Internet Orders



Jurans Quality Handbook

by Juran & De Feo
The essential quality reference
for most ASQ exams
En Espaol


Implementing Six Sigma

by Forrest W. Breyfogle, III
A great CSSBB reference

CSSYB Primer

by Wortman & Richardson

The lastest ASQ exam.

Green Belt


The Spanish version of the

CSSGB Primer.

by Tracy Omdahl

More than 2500 definitions.

Great for any ASQ certification.


LSS Primer
The Lean Six Sigma Primer is
written to a QCI BoK. There are
more case studies and lean content
than in any other QCI products. 400
questions are included. A solution
text is also available.

by Tracy Omdahl

Contains 2800 definitions.

Helpful for Reliability and
Quality Engineers.

ISO 9001 Internal

Auditing Primer

ISO Primer
by Bensley & Wortman

by Greg Wies & Bert Scali

A convenient book for training internal

auditors to the ISO 9001 expectations.
An instructor CD is available.

Reliability & Maintenance

Analyst CD
by Bryan Dodson

Solve your Weibull, reliability, warranty, Bayesian &

Maintenance, prediction & estimation problems.

Measurement Analyst CD
Performs all measurements required in the AIAG manual.
Contains ANOVA methods and excellent graphs.
Site and global license available!!!

Used by Chrysler, ITT, FedEx, Ford,

TRW, GM, HP, U.S. Postal Service


Presents a thorough treatment

of the ISO implementation and
documentation process.
There are generic manuals on
the CD.

Quality System
by Edenborough


Details the selection,

organization, and writing
of quality documents.
The disk contains
procedures and work


Drone Dilemma?

Opportunities abound, but safety concerns have some looking for more regulations
Since Amazon made a splash a few years

Farmers want to operate them to moni-

authorities, such as police, firefighters and

ago with plans to incorporate unmanned

tor crops and tailor their use of pesticides,

other first responders, also are expected to

aircraft systems (UAS) into its package

herbicides, fertilizers and other applications.

invest in the technology.5

delivery service, all sorts of industries have

Utilities are considering them to inspect

been abuzz about drones and brainstorm-

electric and gas lines in remote areas.

ing innovative ways to use this burgeoning


To me, the diversity of industries that

Addressing safety concerns

Along with the excitement and enthusiasm

are coming forward in this initial phase [of

over drones, concerns about aviation safety

applying for FAA special permits] and saying

surrounding this advancing technology

ing too fast for the U.S. Federal Aviation Ad-

wed like to fly using [drones] is the most sig-


ministration (FAA) to keep up with concerns

nificant element, said Brian Wynne, CEO of

over safety?

the Association for Unmanned Vehicle Sys-

amples of disruptive drone activity:

tems International, a trade group. We think

Pilots at New Yorks John F. Kennedy In-

But is interest and usage in drones mov-

The FAA has to act and toughen up the

Consider just a couple of recent ex-

rules before a tragedy occurs, be-

ternational Airport reported four

cause if a drone were sucked into

drone sightings within a three-

a jet engine of a plane filled with

day stretch in late July and early

passengers, untold tragedy could

August. Other reports of near

result, and we do not, do not, do

collisions between drones and

not want that to happen, said Sen.

airplanes have been reported in

Charles Schumer, D-N.Y., a law-

Austin, TX, and Minneapolis in

maker who wants the FAA to speed

recent months. FAA rules pro-

efforts to update regulations and

close loopholes covering the use of drones.1

hibit drones from flying within

theres a ready-made market out there.3
After the FAA establishes the guidelines

five miles of an airport and no higher

than 400 feet.6

High commercial interest

for commercial use, the drone industry said

Already, the FAA has granted special permits

it expects more than 100,000 jobs to be

above flames and smoke from the for-

while it develops comprehensive rules to

created and nearly half a billion dollars in

est fires in July in California, forcing fire

govern how commercial drones should share

tax revenue to be generated collectively by

crews to ground water-dropping aircraft.

the sky with passenger planes. Proposed


The delays allowed the fires to spread,

Unmanned devices were spotted flying

rules for commercial drones were released

Its also predicted that drone activity

resulting in devastating property losses.7

in February, and officials are now reviewing

could be worth tens of billions of dollars

FAA spokeswoman Elizabeth Isham Cory

thousands of public comments that were

to U.S. companies over the next decade as

said the agency receives about 60 reports

submitted. The FAA has granted 944 com-

demand for this technology rises. Organi-

from pilots each month alerting the agency

mercial drone permits as of July 28with

zations are expected to spend money on

of drones flying too close to airports, air-

thousands more applications pending.2

drones to use for surveillance activities,

planes or helicopters.8

For instance, real estate businesses want

agriculture, weather and environmental

Some state and federal-level lawmak-

to use commercial drones to showcase

monitoring, oil and gas exploration, and

ers, as well as private companies, are

properties with videos taken from the air.

aerial imaging and mapping. Government

looking to take action to protect the skies

12 QP

and further regulate drones:
State: Proposed state legislation in California
would allow firefighters and law enforcement
personnel to take down drones hindering emergency operations. The proposed law would give
firefighters and other first responders immunity
if they damage drones that are interfering during a fire or other emergency. Another piece of
legislation would make it a misdemeanor to fly
a drone over a forest fire. Drone operators could
face up to $2,000 in fines.9
Federal: In addition to the FAA finalizing
guidelines around commercial drones, a big
piece of legislation in Washington, D.C., the
Consumer Drone Safety Act, would address
concerns around consumer, or recreational,

Whos Who in
NAME: Himanshu Trivedi.
RESIDENCE: Ahmedabad, India.

EDUCATION: Doctorate from the Birla Institute of Technology and Science in Pilani,
INTRODUCTION TO QUALITY: Trivedi learned from his parents
and teachers at CN Vidyalaya school in Gujarat, India, that
quality is to achieve perfection. He was formally introduced to
quality by professors at Shantilal Shah Engineering College in
Gujarat, India, and the Birla Institute of Technology and Science
in Pilani, as well as his doctoral guide. While working at Crompton Greaves and Bosch Rexroth, his mentors also guided him to
explore different aspects of quality management.

drones. The act would create federal regulations

CURRENT JOB: Vice president and technical plant manager at Bosch Rexroth India.

regarding when, where and how consumer

PREVIOUS JOBS: Responsible for quality management and methods at Bosch

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

drones can be operated, while requiring new

safety technologies be built into all new drones.
This includes collision-avoidance technology, transponders that signal a drones location
to air traffic controllers and other aircraft, and
geo-fencingtechnology that creates a virtual
global-positioning system fence around no-fly
zones that would prevent drones from entering
areas near airports or other restricted airspace.
The bill also calls for anti-tampering safeguards
that would prevent users from modifying consumer drones after they are purchased.10
Private companies: Amazon, too, has proposed a blueprint for a low-altitude air-traffic system, said Gur Kimchi, a vice president who heads
the companys drone-delivery division. Trafficking
the skies is essential before the worlds largest
online retailer can revolutionize how packages
are delivered using drones, he said.11
The only way drones can dart across the skies

ASQ ACTIVITIES: Trivedi has been an ASQ member since 2001 and helped establish
ASQs Ahmedabad local member community in 2010 when ASQ India started its
operation. Since then, he has served as chair of the ASQ Ahmedabad chapter and
has been actively involved in spreading quality knowledge.
OTHER ACTIVITIES/ACHIEVEMENTS: Nominated as member of the board of
studies for a few institutes in Ahmedabad. Awarded Fellow of the National Center
of Quality Management, India. Senior member of the Indian Institute of Industrial
Engineers, India.
PUBLICATIONS: Co-editor of Quality Management for Zero Defect and Zero Effect
(ASQ India, 2014). Authored, co-authored and presented several papers at referred
journals, and national and international conferences.
RECENT HONORS: Elected to ASQs 2014 class of Fellows. Named one of 40 New
Voices of Quality by QP in 2011. ASQ-certified manager of quality/organizational
PERSONAL: Wife, Dhara; daughter, Isha; and son, Jignasu.

without hitting each other or threatening tradi-

FAVORITE WAYS TO RELAX: Reading and spending time with family.

tional aircraft is by requiring the equivalence of

QUALITY QUOTE: Quality is creating the right mindset and passionately working
toward excellence through a proactive approach and effective systems.

flight plans to be filed and ensuring that drones

(continues on p. 14)

September 2015 QP 13

Mr. Pareto Head


Dealing with drones (continued from p. 13)

communicate their positions to a centralized


computer system available to all operators, ac-

1. Sullenberger: Drone Aircraft a Grave Threat to

Aviation Safety, Aug. 3, 2015, CBS-DC, http://
2. Bart Jansen, Study Finds Showcasing Real Estate
Most Popular Business Use for Drones, USA
Today, July 31, 2015,
3. Ibid.
4. Christopher Doering, Growing Use of Drones
Poised to Transform Agriculture, USA Today,
March 23, 2014,
5. Clay Dillow, What is the Drone Industry Really
Worth? Fortune, March 12, 2013, http://fortune.
6. Sullenberger: Drone Aircraft a Grave Threat to
Aviation Safety, see reference 1.
7. Matt Hamilton and Veronica Rocha, $75,000 in
Rewards Offered to Catch Operators Who Flew
Drones Above Fires, Los Angeles Times, July 28,
8. Nick Ferraro, Drone, Airliner in Close Encounter
Near Twin Cities Airport, St. Paul Pioneer Press,
Aug. 5, 2015,
9. Matt OBrien, Drone Traffic Control? NASA, Amazon and Google Partner to Manage Self-Driving
Swarms, San Jose Mercury News, July 28, 2015,
10. Clay Dillow, Is Congress New Drone Safety
Act an Innovation Killer? Fortune, June 23, 2015,
11. Alan Levin, Amazon Envisions Distinct Drone
Zones for Future Delivery Fleet, Bloomberg
Business News,
12. Ibid.
13. Ibid.
14. Grant Gross, U.S. to Begin Talks on Drone Privacy Standards, PC World, July 13, 2015, http://

cording to Kimchi.12
Its completely doable, Kimchi said. We can
only be safe and efficient if everybody else is
safe and efficient.


Privacy and quality of life

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

14 QP

associate editor

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



QP occasionally highlights an open-access article from one of ASQs
seven other journals.
This month, read Finding Threats and Hazards Simultaneously in
the Concept Phase of System Development, which appeared in the
June edition of the Software Quality Professional
Author Masao Ito focuses on finding hazards
and threats to assure system safety and security.
He uses the item sketch and goal model and applies guidewords.
Masao also uses standards and the example
of the automobile for explanation purposes, but
thinks this method applies to various domains.
To access the 10-page article in PDF format, click on the Current
Issue link on SQPs webpage at From there,
you also can find a link to information about subscribing to the quarterly

Software Quality





2 015

Implementing Functional Safety Standards

Richard Messnarz, Christian Kreiner, Andreas Riel,

BernhardSechser, Klaudia Dussa-Ziegert, Risto Nevalainen, and

Taking a Fully Integrated Approach to Implementing

Functional Safety According to ISO 26262 Successfully
Serge Tichkiewitch, Andreas Riel, Richard Messnarz, and
Christian Kreiner

A GSN Approach for Risk Management

in Structured Assurance Cases
Xabier Larrucea and Izaskun Santamaria

The AQUA Automotive Sector Skills Alliance: Best

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

Finding Threats and Hazards Simultaneously in

the Concept Phase of System Development
Masao Ito

QP occasionally looks back on an event or person that made a difference
in the history of quality.

Sept. 17, 2013

Eiji Toyoda died at the age of 100 on this date. The well-known industrialist helped propel his familys automobile companyToyota Motor
Corp.into a worldwide force and changed the way automobiles are
Eijis cousin, Kiichiro Toyoda, created the automaker but resigned in
1948. Eiji Toyada became involved in the company and was sent to the
United States in 1950 to study the auto industry and American manufacturing methods. He returned and redesigned Toyotas plants with advanced assembly techniques and machinery.
The unique Toyota management approach had three main objectives: keeping inventory to a minimum through kanban or a just in time
system, ensuring each assembly step is performed correctly the first time,
and reducing the amount of human labor that went into assembling each
In 1967, Toyoda was named president of the automaker. Under his
watch, Toyota sold an all-time high 1.7 million vehicles in Japan and
1.7 million vehicles overseas in 1985, and profits peaked at $2.1 billion.
Toyoda stepped down as chairman of Toyota in 1994 at age 81.
SOURCE: (case sensitive).

Healthcare organizations that received the
Baldrige National Quality Award matched or exceeded the measurements of healthcare quality
and patient experience of their nearby competitors, according to a recent study.
Thirty-four organizations that received the
award were compared with 153 of their competitors located within a 25 to 50-mile radius. Researchers examined data for 39 measurements
that U.S. hospitals publicly report to the Centers
for Medicare and Medicaid Services (CMS).
The patient-experience
results data come from
Hospital Consumer Assessment of Healthcare Providers and Services (HCAHPS)
surveys of patients.
The HCAHPS patient
survey results were the
most significant findings
in this study, wrote Ron
Schulingkamp and John
R. Latham, the research
Hospitals that used the
(Baldrige Healthcare Criteria
for Performance Excellence, [abbreviated by the
authors as HCPE]) had higher means and lower
standard deviations (indicating a measurable
positive patient experience) than the non-HCPE
hospitals in all 10 measures, the researchers
The differences were statistically significant
for nine of those 10 measurements, the authors
wrote, showing there is a definite positive effect on patient experience with the use of the
For more on the study, which was featured
in the recent Quality Management Journal
article Healthcare Performance Excellence: A
Comparison of Baldrige Award Recipients and
Competitors, visit

September 2015 QP 15


will be held in Washington, D.C., on Oct. 1.

Oct. 19-23 in Cincinnati. For more informa-

THE DEADLINE TO submit nominations

For more information about the celebration,

tion about the five-day event, visit www.

for next years Harry S. Hertz Leadership


for the long-time leader of the Baldrige

TO MARK WORLD Statistics Day on Oct.

THE ANSI-ASQ National Accreditation

Performance Excellence Program. For more

20, a data visualization competition is be-

Board has become the first accreditation

details about the award, the nomination

ing held by and John Wi-

program to offer the new international

process, award criteria and a list of the 11

ley & Sons Ltd. For more information about

featured standards (IFS) Food Store third-

selection committee members, visit www.

the competition, visit www.statisticsviews.

party retail inspection standard in the

com/view/WorldStatsDayComp.html (case

Americas. The IFS Food Store standard is


the only third-party inspection program

Award is Sept. 20. The award is named

THE U.S. CELEBRATION of World Standards

based on ISO/IEC 17020, which is currently

Day, an event that recognizes the critical


available from a leading global scheme

role of various stakeholders across the stan-

Excellence (AME) announced the eight key-

owner. For more information about the

dards community, including business lead-

note speakers who will be featured at its

accreditation, visit

ers, industry, academia and government,

annual AME Excellence Inside Conference


Looking for Your Typ e

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

2016 Quality Progress Editorial Calendar


Back to Basics: Best Of Edition


Lean and Six Sigma


The Multi-Generational Workforce


The Cost of Quality




Change and Change Management


The QP Career Guide


Supply Chain and Stakeholders

September Benchmarking

Standards and Auditing


40 Under 40


Salary Survey

If you want to write for a specific issue,

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


16 QP

Get Your ASQ Certification

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

Upcoming Application Deadline: October 16, 2015

Exam Date: December 5, 2015
For more information or to apply for an exam, visit





The Global Voice of Quality



ISO 9001:2015
Eight experts outline key changes
and how to handle them

ISO 9001:2015

REVISIONS OF ISO management systems are often accompanied by

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

September 2015 QP 19


BILL ASTON is managing director of Aston Technical Consulting Services LLC in Kingwood, TX, and worked 40
years in the oil, gas and chemical industries. A senior member of ASQ, Aston is an ASQ-certified quality auditor,
an Exemplar Global-certified quality management system (QMS) auditor and a Professional Evaluation and Certification Board-certified trainer and lead auditor. He is also a voting member of the U.S. Technical Advisory Group
to ISO Technical Committee 176 (TAG 176) and the American Petroleum Institute Quality subcommittee 18.
SUSAN L.K. BRIGGS is a member of the task force in the Joint Technical Coordination Group that wrote Annex
SL and the associated guidance. She is the chair of TAG 207 on environmental management and the convener
of the international working group revising ISO 14001:2015. She has a bachelors degree in natural science
from Harvard University in Cambridge, MA. Briggs is an ASQ-certified quality/organizational excellence manager, auditor and engineer.
CHARLES A. CIANFRANI is a principal consultant for Green Lane Quality Management Services in Green Lane,
PA. An ASQ fellow, Cianfrani is a U.S. expert representative to ISO Technical Committee 176 (ISO/TC 176). He has
an MBA from Drexel University in Philadelphia and a masters degree in applied statistics from Villanova University in Pennsylvania. Cianfrani has implemented ISO 9001-compliant processes on six continents.

DEANN DESAI is a project manager for Georgia Techs Enterprise Innovation Institute in Atlanta. She has a
masters degree in statistics and polymers from the Georgia Institute of Technology in Atlanta. An ASQ member,
Desai is an Exemplar Global-certified QMS lead auditor, energy management lead auditor and environmental
management systems lead auditor. Desai is a member of multiple ISO standards committees, including TAG 176
and the task force in the Joint Technical Coordination Group that wrote Annex SL and the associated guidance.
ALLEN GLUCK is president of ERM31000 Training and Consulting in Spring Valley, NY, and an adjunct professor
at Manhattanville School of Business in Purchase, NY. He has a masters degree in leadership from Bellevue
University in Nebraska. Gluck is an ASQ member and a member of TAG 176, which develops ISO 9001, and TAG
262, which develops ISO 31000.

PAUL PALMES is president and principal consultant with Business Systems Architects Inc. in Fargo, ND, and
Prescott, WI. He is a member of TAG 176 and chair of international ISO/TC 176, subcommittee 1, responsible for
the revision of ISO 9000. He has been international ISO/TC 176 liaison to the International Accreditation Forum
(IAF), co-chair of the IAFs ISO 9000 advisory group, and member of the Auditing Practices Group and the Accreditation Council of the ANSI/ASQ National Accreditation Board. Palmes is an ASQ-certified quality manager,
British Standards Institution-certified ISO 9001 auditor and has a masters degree in administration from Gonzaga University in Spokane, WA.
DENISE ROBITAILLE is the author of 12 books, including ISO 9001:2008 for Small and Medium-Sized Businesses (ASQ Quality Press, 2010), and an internationally recognized speaker and trainer. She is an active member
of TAG 176, where she has participated in the revision of multiple standards. Robitaille is an ASQ fellow, an
Exemplar Global-certified lead assessor and an ASQ-certified quality auditor.

JOHN E. JACK WEST is a member of Silver Fox Advisors in Houston. He is past chair of TAG 176 and lead
delegate of the committee responsible for the ISO 9000 family of quality management system standards. He is
an ASQ fellow and has co-authored several ASQ Quality Press books.

20 QP

ISO 9001:2015

Prepare for a New Structure

by Deann Desai and Susan L.K. Briggs
What is the change?

a unifying and agreed-on high-level structure, identical

The structure of ISO 9001 has been revised. Clauses and

core text, and common terms and core definitions.

subclauses are retitled and reordered according to a

There are 10 elements in the Annex SL high-level

high-level structure that allows for all management sys-


tem standards (MSS) to be aligned.

1. Scope.

To fully understand this change, some background

2. Normative references.

explaining why it was done should be helpful. From the

3. Terms and definitions.

early 1990s, the International Organization for Standard-

4. Context of the organization.

ization (ISO) technical committee for quality manage-

5. Leadership.

ment (ISO/TC 176) and its technical committee for en-

6. Planning.

vironmental management (ISO/TC 207) worked together

7. Support.

to enhance compatibility and avoid conflicting require-

8. Operation.

ments between ISO 9001 and ISO 14001, the internation-

9. Performance evaluation.

al environmental MSS.

10. Improvement.

In 2003, the ISO General Assembly received advice

These elements have driven the changes that users

from advisory and user groups that greater alignment of

will find in ISO 9001, including the restructuring of the

the structureincluding clause sequence and require-

standard from eight clauses in the 2008 version to 10

ments in the standardswas desirable and achievable,

clauses in the 2015 version.3

and that this would benefit organizations implementing

more than one MSS.

What do I need to do?

In 2005, the ISO Technical Management Board estab-

A frequently asked question about this change is: Must

lished a technical advisory group to fulfill this task, and a

organizations renumber their documents and other rel-

joint vision and high-level structure for all MSSs was de-

evant items based on the new structure of the standard?

veloped. Building on this, the group developed the MSS

The short answer is: No, you do not need to renumber,

requirements, which were published as Annex SL in the

but many organizations will choose to do so as a tracking

ISO/IEC Directives1, 2 in 2011.

mechanisma way to keep things straight and ensure

Annex SL defines the high-level structure including

they are able to do a full review and cover the require-

common text, terms and definitions along with guidance on

ments. Keep in mind that there is no guarantee the num-

how they should be applied. The impact of Annex SL is that

bering will remain the same in future revisions.

all ISO management system requirements standards will be

Some of the main changes in ISO 9001:2015, includ-

aligned, and ISO will seek to enhance the compatibility of

ing introduction of context of the organization and risk,

these standards through the promotion of identical:

came from the use of the high-level structure.

Clause titles.

One of the key responses in the user survey conduct-

Sequence of clause titles.

ed prior to writing the revision was that the connection


with the larger, strategic view of the organization was

Terms and definitions.

missing. The introduction of a clause related to a con-

These items are permitted to diverge among standards only where necessitated by specific differences in
managing the individual fields of application.

cept called the context of the organization addressed

this concern.
The intent of this clause is for organizations to have a
high-level (strategic) understanding of the important is-

What does it mean?

sues that can affect a management systempositively or

The aim of Annex SL is to enhance the consistency and

negatively. Part of an organizations context also includes

alignment of existing and future ISO MSSs by providing

relevant needs and expectations of interested parties that

September 2015 QP 21

apply to its QMS. Knowledge of the issues and inter-

prevents or reduces undesired effects, and achieves

ested party requirements is used to guide the efforts to

continual improvement. Annex SL calls for actions to

plan, implement and operate a QMS.

address risks and opportunities in subclause 6.14 but

The issues identified by an organization and the relevant requirements of interested parties are linked to

does not require risk management, risk assessment or

risk treatment.

the section on planning. The organization plans how

The addition of these two strategic business pro-

it will address any negative or positive consequence

cesses were included to encourage an organizations

posed by these issues and requirements in a prioritized

top management to become more actively engaged,

fashion in its QMS.

ensuring the QMS takes a more strategic view and is

The purpose of planning is for an organization to

integrated into its business processes, with the overall

anticipate potential scenarios and consequences, and

intent to promote improved performance of the QMS.

as such, is preventive in addressing undesired effects

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


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

Understand Your Context

by John E. Jack West and Charles A. Cianfrani
What is the change?

direction, and to monitor and review information re-

The latest edition of ISO 9001 contains content that will

lated to these external and internal issues.

appear new to some users. The newness of the content

These requirements inject a QMS into an organiza-

will vary widely among organizations depending on

tions strategic planning process. At a minimum, to de-

their existing QMSs. An organizations prior compli-

termine external and internal issues that are relevant to

ance could have ranged from the absolute minimum

its purpose and its strategic direction,2 an organization

to deployment of processes that address the explicit

must know its strategic direction.

requirements and the intent of the latest requirements.

This clause introduces the concept of requiring an

ISO 9001:2015s clause 4, dealing with context of the

organization to think at strategic and tactical levels

organization, therefore may require a widely different

when it develops and deploys its QMS. Neither big-pic-

range of attention by organizations transitioning to the

ture strategic thinking nor detailed analysis and tacti-

new version.

cal thinking is sufficient by itself.

Clause 4 introduces some new language and ex-

The standard mandates consideration of internal

pands concepts related to defining requirements. A few

and external issues that affect the ability of the organi-

of the more notable changes include:

zation to achieve its intended results. The requirements

Understanding the organization and its context.

also say the organization shall monitor and review the

External and internal issues.

issues it considers to be relevant to its purpose.

Understanding the needs and expectations of relevant interested parties.

What does it mean?

Subclause 4.1 contains requirements for an organi-

The requirements for understanding an organization

zation to determine external and internal issues that

and its context mean an organization must know itself

can affect and are relevant to its purpose and strategic

and the external organizations and factors that do or

22 QP

ISO 9001:2015

can affect it. Achieving such an understanding can result

considered for serious attention. Self-assessments can

from activities such as performance of competitive anal-

be complex, using criteria such as those of the Malcolm

ysis, assessment of existing and emerging technology,

Baldrige National Quality Award, the European Founda-

and evaluation of its impact on the environment.

tion for Quality Management or the ASQ guidelines for

Such activities and assessments are elements of over-

performing a QMS self-assessment.

all strategic and tactical planning for an organization and

Assessment also can be simplified by using the seven

its associated QMS. It also forms a context for develop-

quality management principles as a guide.4 It is up to

ing, implementing, maintaining and improving a QMS.

each organization to determine how detailed the analy-

This subject is a normal topic for top managers and is

interrelated with subclause 5.1.1 on leadership and commitment,3 which requires top management to ensure a

sis should be and what follow-up action, monitoring and

review is needed.
External issues can be found through several tech-

quality policy and quality objectives are compatible with

niques such as analysis of:

an organizations strategic direction and context. This is

Economic environment and trends.

a key top management role in the development of a QMS.

International trade conditions.

Competitive products and services.

What do I need to do?

Opportunities and conditions related to outsourcing.

What is meant by determine external and internal is-

Technology trends.

sues? What should be considered? How far should you

Raw material availability and prices.


Potential changes in statutes and regulations.

One suggested approach is to have a formal process

for deciding what to consider and why. This approach
makes sense for several reasons:

Benchmarking best-in-class performers in and outside the current marketplace.

Also consider the potential interactions with other

1. It formalizes the process to ensure it is invoked.

processes of your QMS. For example, subclause 4.1 may

2. It precludes going overboard on determining pertinent

have direct or indirect interactions with your processes

external and internal issues.

3. If certification is an organizational objective, it pre-

dealing with interested parties, risks and opportunities,

or with clauses 8, 9 and 10.

empts disputes with external auditors regarding

These new requirements related to the organization

compliance. The notes to subclause 4.1 provide guid-

and its context should provide the organization an op-


portunity to expand the breadth and depth of its QMS,

An organization, for example, could develop a list of

integrate the QMS with the strategic and tactical manage-

areas in which issues could exist and perform periodic

ment of the organization, and align objectives throughout

evaluations of any existing or emerging problems that

the organization.

might affect meeting requirements.

Examples of internal issues that could be considered
Internal audit results and self-assessment results.
Analysis of quality cost data.
Analysis of technology trend information.
Competitive analysis.
Results of customer reviews, audits, complaints and
Actual versus intended internal values and culture.
Organizational performance.
Best practices of the organization and comparisons
with industry benchmarks.
Employee satisfaction data analysis.
One process that is underused but powerful in identifying internal issues is a self-assessment. It should be

1. International Organization for Standardization, ISO/FDIS 9001:2015Quality
management systemsRequirements, clause 4.
2. International Organization for Standardization, ISO/FDIS 9001:2015Quality
management systemsRequirements, subclause 4.1.
3. International Organization for Standardization, ISO/FDIS 9001:2015Quality
management systemsRequirements, subclause 5.1.1.
4. International Organization for Standardization, ISO/FDIS 9000:2015Quality


Are you a small business trying to navigate the transition to ISO

9001:2015? Read about the unique obstacles small business face in
implementing ISO 9001 and the resources available to help in Denise
Robitailles online sidebar Resources: The Small Business Challenge,
on this articles webpage at

September 2015 QP 23

Consider Risk
by Denise Robitaille
What is the change?
Many of the changes in ISO 9001:2015 will involve a

ISO 9001:2015 disperses language relating to risk

paradigm shift across all functions. The most prevalent

throughout the standard. The logical segue is that be-

of these relates to the concept of risk-based thinking.

cause the QMS touches most processes and departments, the need to engage in risk-based thinking is

What does it mean?

similarly expanded to encompass multiple functions

The idea of risk-based thinking isnt particularly dif-

throughout the organization.

ficult. Whenever an organization decides to change

What happens if you change the design of your most

something or to respond to an impending change, there

popular product? You improve your position in the

are choices, consequences, opportunities and risks.

marketplace and beat the competition. You also incur


ISO 9001 includes two new and related requirements: under-

popular internationally, and it will be helpful in implementing ISO

standing the organization and its context, and risk-based think-

9001:2015. As a guidance document, it allows for tailoring to

ing. The latter is a term that is nonexistent in current quality and

various systems including the management of quality. It is help-

risk nomenclature. How should you understand, implement and

ful for understanding the organization and its context, which

audit to this requirement?

is sparsely defined in ISO 9001:2015, but more fully detailed in

Fortunately, you dont have to reinvent the wheel. These

concepts and their implementation are detailed in ISO 31000,1
the international risk management standard. Although ISO

sections 4 and 5 of ISO 31000. These sections explain the how

and why of establishing the context.
Like ISO 9001, ISO 31000 is more clearly understood after

31000 uses different terms, referring to that standard can help

professional training. Quality professionals who master ISO

organizations implement risk-based thinking in the context of

31000 will be able to identify how detailed an organizations

ISO 9001.

risk-based thinking implementation must be to satisfy the re-

The writers of ISO 9001:2015 state that risk-based thinking

has always been implicit in ISO 90012 and chose not to require

quirements of ISO 9001:2015.

Why should your organization embrace risk management as

a full, formal and systemic risk management method, such as

part of your quality system? The answer is stated in ISO 31000:

ISO 31000. The risk-based thinking requirement allows organiza-

All organizations manage risk to some degree.3 In laymans

tions the flexibility to choose either a basic approach or a more

terms, managing risk is simple: Make decisions while consider-

extensive formal risk management process based on what is

ing how the potential consequences of unknown factors can

appropriate for an organization.

help or hinder your organizations objectives.

Explicit in the new standard, however, is the requirement that

This idea is not new. The management of uncertainty is

some minimal risk management be integrated into an organiza-

something you do each day in your personal and professional

tions quality system. Indeed, the writers deliberately created

lives to ensure you achieve your objectives. The requirement

the term risk-based thinking to encompass the varying, ac-

that consideration of uncertainty be part of formal and auditable

ceptable degrees in which organizations may choose to manage

processes will serve to further quality and corporate objectives.

risk. Employing the term risk management may have implied

full adherence to the ISO 31000 standard is required, a suggestion defeated in early international revision negotiations.
While using ISO 31000 is not required in ISO 9001:2015,
the existing risk management standard already has become

24 QP

Allen Gluck
1. International Organization for Standardization, ISO 31000:2009Risk management
Principles and guidelines.
2. International Organization for Standardization, ISO/FDIS 9001:2015Quality management
3. Ibid.

ISO 9001:2015

the need to carry inventory of replacement parts be-

ses and implementing sophisticated risk management

cause youve made a commitment to your customers

programsall slick with data, pretty charts and graphs

to continue to support older versions of the product.

printed on high-gloss paper. This is hardly a capabil-

How about signing a contract that will double your

business? Youll make a ton of money if you can: Get

ity for a small delivery service organization or a fiveperson machine shop.

suppliers to ship extra raw material, hire 15 more

To help an organization of any size get over this

techs, put on a second shift and maintain the produc-

hurdle, look no further than clause 4 of ISO 9001:2015.1

tion schedule to keep your other customers happy.

All of the language about the context of the organization is directly relevant to the conversation about risk.

What do I need to do?

To understand your risks, you must understand your

All organizations, but especially small companies,

organizationits internal and external issues, the in-

must apply risk-based thinking in their internal envi-

terested parties that can have an effect on it and its

ronments. A small amount of effort along these lines

ability to fulfill customer expectations.

can lead to big results. ISO 9001:2015 allows organiza-

These concepts also can be parsed into smaller

tions the flexibility to apply as little effort as is needed.

components. For smaller organizations, issues can be

When implementing risk-based thinking, parse

as simple as the retirement of one person, the loss of a

things out into manageable chunks. The benefit is that

supplier, a change in cash flow, a major road repair out-

youll have fewer unpleasant surprises resulting from a

side their entrance or change in the local schools cal-

failure to adequately assess the risk associated with a

endar affecting parents who need daycare. All of these

change. The change can be as small as substituting an

events carry risks that must be managed properly.

epoxy or as overwhelming as moving the business to a

new facility.

There are other changes that must be understood

and implemented. All the changes carry some benefit.

One of the side benefits of the inclusion of risk-

The transition process itself carries its own benefit

based thinking in ISO 9001:2015 is that it eliminates the

because implicit in the transition is the opportunity to

ineffectual and cumbersome preventive action process

objectively assess a system and sweep away what isnt

included in ISO 9001:2008.


Often, risk is presumed to be within the purview

of large companies with loads of quality technicians
and MBAs performing failure mode and effects analy-

1. International Organization for Standardization, ISO/FDIS 9001:2015Quality
management systemsRequirements, clause 4.

Leaders, Step Up
by Paul C. Palmes
What is the change?

ed issueswith primary top management interaction

The 2015 revision of ISO 9001 contains several impor-

through management review.

tant improvements regarding top management. Specifi-

Thats about to change. According to subclause 5.1.1,

cally, subclause 5.1.1 on leadership and commitment

top management is required to demonstrate leadership

for the QMS1 includes 11 requirements designed to en-

and commitment with respect to the QMS by:

sure top management is involved and committed more

1. Taking accountability of the effectiveness of a QMS.

than ever before to the QMS.

2. Ensuring the quality policy and quality objectives

Observers of ISO 9001 throughout the years have

are established for a QMS and that they are compat-

consistently and correctly commented that QMS imple-

ible with the strategic direction and the context of

mentation results suffer without real top management

support. As a result, organizations are left to install
bolt-on quality systems limited to production relat-

an organization.
3. Ensuring the quality policy is communicated, understood and applied in an organization.

September 2015 QP 25

4. Ensuring the integration of the QMS requirements

into an organizations business processes.

If you can clearly imagine the best outcome of each

meeting, you can work backward to imagine everything

5. Promoting awareness of the process approach.

you may need to achieve a successful set of results.

6. Ensuring the resources needed for a QMS are avail-

After all, for many organizations, effective implemen-

7. Communicating the importance of effective quality
management and of conforming to QMS requirements.

tation of subclause 5.1.1 will require a fundamental

paradigm shift in which top management participates
rather than observes.
There is, for example, a new requirement to promote

8. Ensuring a QMS achieves its intended results.

awareness of the process approach. No doubt, this may

9. Engaging, directing and supporting persons to con-

become a teachable moment for many organizations,

tribute to the effectiveness of a QMS.

10. Promoting continual improvement.

requiring prepared materials to explain this fundamental concept to top management during these meetings.

Supporting other relevant management roles to

Take your time. Be prepared and professional in

demonstrate leadership as it applies to leaders re-

your approach. Develop appropriate action items and

spective areas of responsibility.

venues for each requirement. Perhaps your organization routinely schedules an all-organization business

What does it mean?

status meeting conducted by top management. This

From the perspective of an organization that is already

may be the perfect place to communicate the impor-

implementing ISO 9001 and looking to transition to the

tance of effective quality management and of conform-

new version of the standard, some will proudly affirm

ing to QMS requirements.3

the existing link between quality and business goals,

Others requirements in subclause 5.1.1 are also fair

while others face a major realignment of their existing

game for such events, and if you use PowerPoint to


present, you now have a record of compliance. (The

Yes, some of the above requirements, such as en-

correct term is now documented information, but its

suring that the quality policy is communicated, un-

still acceptable to use terms to which youve become

derstood and applied within the organization, are


management responsibility-related holdovers from

Naturally, to just proclaim support is not enough,

the 2008 revision. Several additional requirements in

and similarly no one expects top managers to move

the 2015 revision, however, affirm a fundamental shift

into the quality department. The real work will be

from having top management simply provide direction

somewhere in between when it becomes obvious to

and support to its becoming a key participant.

everyone that top management actually is using the

The QMS now must consider how to manage ensur-

quality system to guide and validate its decisions and

ing the integration of the QMS requirements into the

to encourage the discovery of new areas of improve-

organizations business processes. They are now one

ment throughout the organization.

and the same, requiring quality objectives to support

the achievement of the organizations business goals.

Fundamentally, clause 5.1.1 in ISO 9001:2015 is a

call for top management involvement in the QMS. In-

Who better to ensure business success than top

tegration of the QMS requirements into the organiza-

management? After all, top management also is tasked

tions business processes requires analysis and collab-

in the new version of ISO 9001 with engaging, direct-

oration on both sides. As the two become one, working

ing and supporting persons to contribute to the effec-

together to support common goals, the organization

tiveness of the QMS.

develops deeper purpose, strength and success.

What do I need to do?

wish to achieve when you begin with the end in mind.

Thats the vision you must encouragethe goal you

Given the importance of the material, explaining all
these changes to top management will best be accomplished through several meetings. It may be constructive to use the second of Stephen R. Coveys seven
habits by beginning with the end in mind.2

26 QP

1. International Organization for Standardization, ISO/FDIS 9001:2015Quality
management systemsRequirements, subclause 5.1.1.
2. Stephen R. Covey, The Seven Habits of Highly Effective People, Free Press,
3. International Organization for Standardization, ISO/FDIS 9001:2015Quality management systemsRequirements, see reference 1.

ISO 9001:2015

Determine Your
Documentation Needs
by Bill Aston
What is the change?

lowing 18 records to be retained:

One of the more notable changes in ISO 9001:2015 will

1. Monitoring and measurement of resources (sub-

be the nonexistance of any reference to requirements

clauses and, a).

for a quality manual, documented procedures and re-

2. Personnel competency (subclause 7.2, d).

cords to be maintained. Does this mean documented

3. Operational planning and control (subclause 8.1, e).

procedures, records and other QMS documents are not

4. Review of requirements related to products and services (subclause

No, that is not the case. Consider the requirements

5. Design and development inputs (subclause 8.3.3).

of ISO/FDIS 9001:2015, subclause This sub-

6. Design and development controls (subclause 8.3.4, f).

clause requires an organization to maintain document-

7. Design and development output (subclause 8.3.5).

ed information (procedures) to support the operation

8. Design and development change (subclause 8.3.6).

of its processes and to retain documented information

9. Externally provided product and services (sub-

(records) to have confidence that processes were per-

clause 8.4.1).
10. Traceability (subclause 8.5.2).

formed as planned.
Annex A, section A.6, provides guidance regarding
the references made to requirements throughout the

11. Property belonging to customers or external parties

(subclause 8.5.3).

standard to maintain documented information (such

12. Control of change (subclause 8.5.6).

as procedures, quality plans and a quality manual) as

13. Release of product and services (subclause 8.6).

well as to retain documented information (records).

14. Control of nonconforming process output, products

How are an organizations requirements for QMS

documents determined? Every organization will be
responsible for determining the level of documented

and services (subclause 8.7.2).

15. Monitoring, measurement, analysis and evaluation
(subclause 9.1.1).

information, such as procedures, needed to support its

16. Internal audit (subclause 9.2.2).

QMS, processes, product and services.

17. Management review (subclause 9.3.3).

ISO 9001:2015 will specifically require risk-based

thinking to be a part of every organizations process

Nonconformity and corrective action (subclause

approach to quality. Risk-based thinking is not a new

activityits a regular part of an organizations QMS

What does it mean?

and product planning processes, which includes ensur-

Concerning requirements for documented information

ing controls, such as procedures or instructions, are

to be maintained (procedures), ISO 9001:2015 will be

established to address identified risks.

less prescriptive. This increased flexibility will sup-

ISO/FDIS 9001:2015 requires the following docu-

port requirements for documented information to be

mented information to be maintained by every organi-

scaled to be appropriate to the complexity and criti-


cality of the products produced or services provided.

Scope of the QMS (subclause 4.3).

The greater the risk or potential consequences of the

Information needed to support the operation of its

nonconformance, the more control (procedures) re-

processes (subclause 4.4.2, a).

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

quired to address the probability of the risk and its

potential impact.
Documented information may include procedures, work instructions, drawings, checklists, data
sheets, media or records as deemed appropriate for

September 2015 QP 27

ISO 9001:2015

an organizations operation.

ISO 9001:2015 will provide an organization in-

Risk-based thinking is essential for identifying risk

creased flexibility to maintain a QMS specific to its

and the resources, such as personnel competencies,

particular processes and product. Risk-based thinking

equipment, facilities, product and services design, ma-

will drive the organizations need to ensure document-

terials, process procedures and instructions required

ed information, such as procedures, instructions and

to address those risks. ISO 9001:2015 will not require

other QMS documents, are available to address risks

formal risk assessments. The organization will deter-

and opportunities. ISO 9001:2008 certifications will not

mine whether a formal risk assessment is required and

be valid after three years from the publication date of

if so, select a risk assessment method that best suits

ISO 9001:2015.

its needs.

The International Accreditation Forum Informa-

Future QMS audits will require auditors, consul-

tive Document 9: 2015 Transition Planning Guid-

tants and other interested parties to use a different ap-

ance for ISO 9001:20155 provides general guidance to

proach to determining an organizations conformance

organizations, certification bodies and accreditation

with ISO 9001:2015 requirements. Auditors must be

bodies for preparing to transition from ISO 9001:2008

knowledgeable about the risks associated with the

to ISO 9001:2015.

products, services and processes being audited, and be

Future QMS auditing will need a different approach

able to assess the effectiveness of the controls used to

to determining an organizations conformance with

manage those risks.

ISO 9001:2015 requirements. Techniques and skills

for auditors, consultants and other quality profession-

What do I need to do?

als must change to meet the new challenges of ISO

Consider the following actions to prepare for transi-

9001:2015. QP

tioning to ISO 9001:2015:

1. Obtain a copy of ISO FDIS 9001:2015 and become
familiar with its requirements.
2. Attend ISO 9001:2015 training via your registrar, the
Professional Evaluation and Certification Board,
Exemplar Global College, ASQ or other accredited
training providers.
3. Consider training on ISO 31000:2009Risk man-

1. International Organization for Standardization, ISO/FDIS 9001:2015Quality
management systemsRequirements, subclause 4.4.2.
2. International Organization for Standardization, ISO/FDIS 9001:2015Quality
management systemsRequirements, Annex A, section A.6.
3. International Organization for Standardization, ISO 31000:2009Risk managementPrinciples and guidelines.
4. International Organization for Standardization, Technical Committee 176,
Subcommittee 2 (ISO TC/176/SC2) homepage,
5. International Accreditation Forum (IAF), IAF Informative Document 9: 2015
Transition Planning Guidance for ISO 9001:2015, Issue 1, Jan. 12, 2015.

agementPrinciples and guidelines to ensure familiarization with basic risk-management practices

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

28 QP


ISO 9001:2015 is scheduled to be released later

this month and will be available for purchase at Find out more about the new standard by:
Tuning in to the ASQ Standards Channel (videos. to watch
experts discuss changes and transition advice.
Subscribing to the Standards Connection
enewsletter at to
have information delivered to your inbox every
Visiting Standards Central at,
where you can find updates, articles and more.

Prepare for Your Certification Exam

With These Handbooks Available
From ASQ Quality Press!
The Certified Quality Technician
Handbook, Second Edition

The Certified Manager of Quality/

Organizational Excellence Handbook,
Fourth Edition
This handbook addresses organizational issues from
the application of basic management principles to
development of strategies for the new millennium.
This revised handbook offers a global perspective for
those taking the CMQ/OE exam.
Item: H1447

This book supports individuals preparing for,

or those already performing, this type of work.
It serves as a ready reference for quality
technicians and quality technicians-in-training,
as well as a comprehensive reference for those
preparing to take the ASQ Certified Quality
Technician (CQT) exam.
Item: H1422

The Certified Six Sigma Master

Black Belt Handbook

The Certified Quality Inspector

Handbook, Second Edition

This book reflects the most current thinking among

key Six Sigma leaders regarding what should be
contained in the ASQ Master Black Belt Body of
Knowledge (BoK). For quick reference and ease of
use, chapter and section numbering exactly mirrors
that of the BoK.

This handbook supports individuals preparing

to perform, or already performing, this type of
work. It serves as a ready reference for quality
inspectors and quality inspectors-in-training, as well
as a comprehensive reference for those individuals
preparing to take the ASQ Certified Quality Inspector
(CQI) exam.

Item: H1404

Item: H1427

Learn more about these books through the

Quality Press bookstore at





at Software
In 50 Words
Or Less

Software products are

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


Pilot program uses ISO/IEC

25000 family to evaluate,
improve and certify
software products
by Moiss Rodrguez, Mario Piattini
and Carlos Manuel Fernndez


SOFTWARE QUALITY IS a key challenge for organizations because of its impact on final costs. At the same time, software
quality can be a competitive differentiator an organization can offer
to its customers.
The importance of software quality is accentuated when you consider the
losses organizations can incur when quality problems arise in software development projects. In fact, only 39% of software projects finish on time with the
planned resources and with acceptable quality, according to the Standish Groups
latest report The CHAOS Manifesto.1 See Figure 1 (p. 32).
To highlight the importance of software quality, a laboratory in Spain performed a pilot program to evaluate, improve and certify the quality of software

September 2015 QP 31

Software evaluation

with Alarcos Quality Center (AQC), a spin-off of the Uni-

Activities related to software quality have become in-

versity of Castilla-La Mancha, conducted the evaluation

creasingly important, especially as more organizations

and certification pilot project using the new ISO/IEC

outsource their software functions. This means client

25000 family of standards.

organizations must assess and monitor the quality of the

AQC and AENOR are independent organizations. AQC

products they receive from software development orga-

is responsible for evaluating software product quality,

nizations. In turn, these software development organiza-

thus permitting organizations to meet a quality level and

tions must have the necessary resources to ensure the

improve their software products. AENOR, as an auditing

products developed will meet client expectations.

entity, is responsible for certifying the software product

Despite the proliferation of software quality process

certifications (for example, ISO/IEC 15504 Informa-

in cases in which organizations, in addition to improving

their products, wish to become certified.
Initially, this pilot project mostly focused on the qual-

tion technologyProcess assessment and certifications

from the Capability Maturity Model Integration Insti-

ity characteristic of maintainability because:

tute), there is little evidence conformance to process

Maintenance is one of the most expensive phases in

standards actually guarantees good products. In fact,

the software life cycle and, in some cases, can reach

up to 60% of costs.

critics suggest process standards guarantee only the uniformity of output and can possibly institutionalize the

Maintainability is one of the features most frequently

requested by software customers. It must be possible

production of mediocre or bad products.2

for customers to evolve software products they ac-

The idea that software evaluations should be based

quireeither by themselves or via a third party.

on direct evidence about a products attributes rather

than circumstantial evidence about processes used to

Maintenance work on products with little maintain-

build a product3 is becoming more widespread. An ever-

ability is more likely to introduce new bugs into soft-

increasing number of organizations therefore are con-

ware products.

cerned not only about the quality of the processes, but

The evaluation and certification based on this family

also the quality of the products they develop and acquire.

of standards provides software development organiza-

This is because they may have serious quality problems

tions and organizations that acquire such software a set

after the product has been implanted into their servers.

of benefits, which are shown in Figure 3 (p. 34).

The new ISO/IEC 25000 family of standards, also

known as SQuaRE (Software Product Quality Require-

Five activities

ments and Evaluation), appears to meet these needs.

For this project, it was first necessary to create the AQC

ISO/IEC 25000 aims to create a common framework to

Lab using an agile approach,6 responsible for carrying

evaluate software product quality, replacing ISO/IEC

out the software product quality evaluation process. This

9126 and ISO/IEC 14598 and becoming the cornerstone

laboratory performs evaluations by conducting the five

of this area of software engineering.

activities proposed in ISO/IEC 25040:

ISO/IEC 25000 is composed of several parts: ISO/IEC

1. Establish evaluation requirements: This activitys

250404 defines the process of evaluating software prod-

aim is to establish an agreement between the labora-

uct quality, and ISO/IEC 250105 determines the software

tory and client about which purpose and quality re-

product characteristics and subcharacteristics that can

quirements will be considered for the product evalu-

be evaluated (see Figure 2).

ated. To this end, parts of the software product that

The Spanish Associa-

will be evaluated are identified, and the rigor of the

Project resolution
results / FIGURE 1





The results are an initial version of the evaluation

ciacin Espaola de Nor-

plan along with a list of requirements. The pilot proj-


malizacin y Certificacin,

ects scope was the complete software products.


or AENOR), which is a

Although some organizations had defined quality re-


member of the Internation-

quirements for their software products (such as low

al Certification Network

complexity or good documentation), a decision was

(IQNet), in collaboration

made to expand them to the requirements associated

Results from 2012 CHAOS research

32 QP

evaluation that will be performed is clearly defined.

tion for Standardization


Software product quality model from ISO/IEC 25010


Product quality model







Time behavior
Resource use








Fault tolerance




















ably, and the evaluation results are stored in a secure

with the laboratory model.

repository, which can be accessed via a web applica-

2. Specify the evaluation: This activitys objective is

tion that allows visualization and analysis.

to select the quality metrics that will be measured in

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

The result of this activity is a set of values obtained

for all metrics, indicators, subcharacteristics and
quality characteristics.

5. Conclude the evaluation: This activitys purpose is

to analyze the results obtained in the previous activ-

The result of this activity is a refined version of the

ity to ensure no errors occurred during the evaluation

evaluation plan with metrics and defined criteria.

and to generate the final evaluation report. This re-

In the pilot project, all the properties of the quality

port is the main output of the evaluation process and

laboratory model (covered later) were selected as the

will be delivered to the customers to allow them to

thresholds established by the laboratory to certify the

review it and, if necessary, express disagreement.


Figure 4 (p. 34) shows sections of this evaluation re-

3. Design the evaluation: This activitys purpose is to

port for one of the pilot project products. During this ac-

plan the measurement and evaluation activities that

tivity, the laboratory also performs the disposition of the

must be conducted, taking into account the prespeci-

evaluation datathat is, all records that no longer need

fied scope and availability of laboratory resources.

to be maintained (for example, product source codes)

The result of this activity is the final version of the

are removed. This also occurs for confidentiality reasons

evaluation plan, with details of the dates of evaluation

because any data that the client does not wish to remain

activities and the specific resources involved.

in the laboratory after the completed evaluation are re-

In the pilot project, an initial assessment was

turned or eliminated.

planned for each product. This assessment lasted

It is also necessary to consider that the family of ISO/

two weeks. Each organization requested a month to

IEC 25000 standards defines models and processes to as-

correct its software products. Finally, the laboratory

sess the quality of software products, but it does not es-

planned a second evaluation of each product, which

tablish a correlation between the metrics and thresholds

took one week.

needed to identify the specific level of quality a software

4. Execute the evaluation: This activitys purpose is

product has.

to perform measurements on the software product

The laboratory, therefore, has defined not only a mod-

and apply the decision criteria specified in the second

el and a quality process that are aligned with ISO/IEC

activity. Thanks to the automated laboratory environ-

25000, but it also has identified a set of measurable qual-

ment, this activity can be performed quickly and reli-

ity properties from the software products source code.

September 2015 QP 33

Quality properties

structure of a system at any level (for example, sub-

The objective of identifying these quality properties was

systems, packages and classes) facilitates develop-

not to form the largest set of these quality properties pos-

ment and maintenance.

sible, but rather to assemble a whole group that was not

Method sizeThe size of a system directly affects

controversial, based on previous studies and research,

its maintainability because a larger system obviously

and accepted by the scientific community. The main

requires more maintenance. It is considered more ap-

properties are:

propriate to evaluate the size of the elements at a low-

Violation of encoding rulesThis property is

er level by using, for example, methods that directly

based on encoding rules for each language (such as

evaluate the overall size of the system. This is because

Java code standard) and the percentage of violations.

a change does not usually affect the entire system, but

A set of related rules are checked for each quality subcharacteristic.

rather a set of elements.

Duplicate codeThis property refers to code frag-

Code documentationThis property refers to com-

ments repeated in different parts of the system. Du-

ments in the code that are used to explain the codes

plicate code makes it difficult to modify a software

functionality. Well-documented code helps develop-

application because solving a bug or making an im-

ers understand what it does. Comments also may in-

provement to the code requires changes to all parts of

fluence the ability to reuse software because if you

the system where the duplicate code appears.

know the functionality of a module, you can reuse

that module in another system.

CouplingThis property indicates the degree of interdependence among software units (modules, func-

Cyclomatic complexityThis property is related to

tions, classes and libraries, for example). Generally,

the difficulty involved in implementing, testing, under-

the lower the coupling in a software application, the

standing, maintaining or modifying a program. As this

better its design is considered because low coupling

definition shows, the complexity is related to the fol-

improves maintainability (if there is no coupling,

lowing subcharacteristics: analyzability, modifiability

changes to one unit do not affect other units) and in-

and testability. In applications with high complexity,

creases the reusability of software units.

maintenance tasks require more effort and, therefore,

are more costly.

CyclesThis property refers to the existence of cycles of dependence among the system packages. The

StructuringThis property refers to dividing the

acyclic dependencies principle states there must be no

system into smaller parts. The quality of the system

cycles in the dependency structure of a system. The ex-

design is closely related to this property: The correct

istence of cycles in a system has a negative effect on its

maintainability because a change that is made to one

Benefits of evaluating software

product quality / FIGURE 3

packet affects all the packets in the cycle.7

CohesionThis property indicates the degree of relationship between the elements in a module. A class
has low cohesion when it performs several unrelated


Control software product quality.

functions. The functionality provided by its methods

Improve product characteristics.

thus has little in common with them. The analyzabil-

Ensure customers receive the appropriate

level of quality.

ity, modularity and, in general, maintainability are

Compare among competitors products.

Place the product on the market.
Increase product sales.

negatively affected because these systems are more

difficult to understand. They provide features that are
unnecessary and changes in requirements that affect
several modules.

Know the quality of the product purchased.

that acquire

The evaluation process, the quality model and the

Compare between alternatives.

properties, along with a measurement environment,

Establish service-level agreements.

allow a laboratory to evaluate a software product and

Attain vendor independence.

calculate its quality values. The measurement environ-

Minimize production failures.

ment automates the evaluations by up to 90% and has

Reduce the final cost of acquiring software.

34 QP

three different levels:


1. Measuring toolsThese constitute the

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

Example of evaluation report

results / FIGURE 4

XML) containing information about metrics

and violations of programming rules.
The advantage of this level is that it can
easily be expanded by adding new tools
(an organizations own or via a third party)
that analyze new programming languages or
compute new metrics for other quality characteristics.
2. Evaluation systemThis involves the intermediate level of the environment. Its objective is to analyze all the files generated by
the lower level and apply criteria with which
to evaluate the quality model. The result is
the values for quality properties, subcharacteristics and characteristics.
3. Visualization environmentThis represents the top level of the environment. Its
objective is to present the information ob-

tained after the software product evaluation in an un-

the organization will obtain a quality evaluation report

derstandable manner.

(shown in Figure 4). Based on the reports results, the

Besides showing the values of quality properties,

organization may choose to become certified (if the

subcharacteristics and characteristics, this environ-

level is good) or to refactor the product to meet estab-

ment also allows you to obtain a historical report for

multiple versions of a product, compare different prod-

lished quality thresholds.

Step threeWhen the organization has an evaluated

ucts and even generate predefined reports.

product with an adequate level of quality, it can request

Thanks to this framework, the laboratory has achieved

certification from AENOR by providing its data and the

accreditation as a laboratory for quality software prod-

product to be certified.

uct evaluation as it relates to the ISO/IEC 25000 family

Steps four and fiveAENOR will contact the ac-

of standards from Entidad Nacional de Acreditacin, a

credited laboratory (step four) to check whether the

member of the International Laboratory Accreditation

organization really has evaluated its software product

Cooperation under ISO/IEC 17025.

and the level obtained is adequate for the certification.

In this case, the laboratory will provide AENOR with

Six steps to certify products

the evaluation report (step five) for it to review and

After organizations have evaluated and improved their

continue the certification process.

software products, they can choose to certify these prod-

Step sixFinally, AENOR will carry out the certi-

ucts. To do this, the certification entity (in this case, AE-

fication audit using information from the evaluation

NOR) has developed a six-step process for product certi-

laboratory and information obtained after a visit to the

fication and has defined the communication flow, shown

developer. As a result, AENOR creates an audit report

in Figure 5 (p. 36).

with the results and presents the certificate of product

Step oneIf interested organizations wish to certify

quality when applicable (see Figure 6, p. 36).

the quality of a software product, the first step is to

Several assessments and refactoring cycles were

contact an accredited laboratory and request an evalu-

necessary during the pilot project. Three organizations

ation report. At this point, the five evaluation activities

eventually attained quality certifications for their soft-

will begin.

ware products: a document management system, a digi-

Step twoAs a result of product quality evaluation,

tal library for mobile platforms and supplier application

September 2015 QP 35


software for healthcare centers.

The chief information officers of the organizations
that achieved certification noted the main benefits for
their certified software:
The amount of code developed was reduced 40%.
The execution and load speed of applications increased.
The corrective maintenance effort was reduced 90%.
Product quality evaluations were incorporated into
the software development life cycle.

1. The CHAOS Manifesto: Think Big, Act Small, Standish Group, 2013.
2. Barbara Kitchenham and Shari Lawrence Pfleeger, Software Quality: The
Elusive Target, IEEE Software, Vol. 20, No. 1, 1996, pp. 12-21.
3. Tom Maibaum and Alan Wassyng, A Product-Focused Approach to Software
Certification, Computer, Vol. 41, No. 2, 2008, pp. 91-93.
4. International Organization of Standardization (ISO), ISO/IEC 25040 Systems and
software engineeringSystems and software quality requirements and evaluation (SQuaRE)Evaluation process, 2011.
5. ISO, ISO/IEC 25010, SQuaRESystem and software quality models, 2011.
6. Javier Verdugo, Moiss Rodrguez and Mario Piattini, Using Agile Methods to
Implement a Laboratory for Software Product Quality Evaluation, presentation
at the 15th International Conference on Agile Software Development, Rome,
May 26-30, 2014.
7. Diomidis Spinellis, Code Quality: The Open Source Perspective, first edition,
Addison-Wesley Professional, 2006.

This pilot project has gained widespread acceptance

MOISS RODRGUEZ is CEO of the Alarcos Quality Center
(AQC) and director of AQC Lab in Ciudad Real, Spain. He
has a masters degree in computer science from the
University of Castilla-La Mancha in Ciudad Real. Rodrguez
is an Information Systems Audit and Control Association
(ISACA)-certified information system auditor, Asociacin
Espaola de Normalizacin y Certificacin (AENOR)-certified ISO/IEC 15504 chief auditor and Test management
approach (Tmap) Next Certified.

by the participating organizationsthose that succeeded in certifying their products and those that did
notbecause they were able to detect the principal
maintenance problems so they wouldnt repeat them in
the future.
This pilot project also has shown that the software development sector can address certification as it relates
not only to the quality of the processes, but also to the
quality of the software product by using a scheme of international standards such as the ISO/IEC 25000 family.
Finally, after this first pilot project, the scope of laboratory evaluations is now being broadened to include
new quality characteristics of ISO/IEC 25000, such as

MARIO PIATTINI is a full professor at the University of

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

functionality, usability and performance. Furthermore,

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

Flow followed during the pilot

software product certification


1. Request for evaluation of product quality

3. Request for certification

Company interested
in software product

4. Request for evaluation report

Asociacin Espaola de

6. Audit results and

certificate of product quality

5. Evaluation results

2. Quality evaluation report

AENOR = Asociacin Espaola de Normalizacin y Certificacin,
or Spanish Association for Standardization and Certification
AQC = Alarcos Quality Center

36 QP

CARLOS MANUEL FERNNDEZ is manager of information

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

Example of
software product
certificate / FIGURE 6

Whats Online in the

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


ISO 9001 and TQM
Ask the Experts panelist Bill Aston discusses the
relationship between the ISO 9001 internal audit
process and total quality management (TQM).

Triggers: Becoming the Person You Want to Be
Marshall Goldsmith presents research findings on
leadership development, coaching, and engagement,
and introduces a process for changing individual
behaviors and increasing employee engagement.

Access this months featured content and more Web exclusives in the
ASQ Knowledge Center at






The Global Voice of Quality




Evaluating an audit programs

performance with a standardized
approach and the Kano model
by Lance B. Coleman Sr.
In 50 Words
Or Less

A process and form allows organizations to

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

A QUALITY AUDIT program could

be considered a service for an organization thats provided by the quality department. Because of this, the Kano model can
be the ideal lens for analyzing the performance of an organizations quality audit
In the 1980s, Noriaki Kano created the
model as a theory of how to align product
development with customer needs. Kano


focuses on customer service and the benefits of delivering exceptional value to the
customer, whether internal or external,
through service that delights the customer.
The Kano model recognizes four states:
nonperforming (failure), basic must haves
(cost of entry into the marketplace), performing (more is better) and exciting or
delightful service (surprises and delights
the customer).1

September 2015 QP X39

The model (see Figure 1) stresses the pursuit of delightful service delivery as a driver for continuous im-

having the best plan in the world is worthless if that

plan isnt properly implemented.

provement and business success. It also can be used as

The ability to support corporate and site goals is

a powerful visual for displaying progress in customer

an often-overlooked segment of an internal audit pro-

satisfaction, and it reminds staff of the of the organiza-

gram. It also should be seamlessly integrated into a

tions ultimate goaldelivering outstanding (delight-

risk management program and play an integral role.

The next area of the form addressed reporting and

ful) performance.
When I looked at this model, I asked myself: What
would be attributes of a delightful audit program?
A delightful program would excel in monitoring
compliance, managing risk and driving continuous im-

record keeping. For data to become information, it

must be used, which was why data analysis was added
to this area. Reporting, records and data analysis account for another 30% of the base score.

provement while the program itself continues to im-

The reporting strategy for audit results was ad-

prove. To know whether you have an excellent audit

dressed to ensure critical and major concerns were im-

program, an assessment must take place, but complet-

mediately reported to the appropriate parties. Safety,

ing a quantifiable, accurate and objective assessment

legal and functional issues are examples of findings

of an internal quality audit program is easier said than

that might be reported to a wider group of managers.

The final 30% of the score relates to having adequate

I started by creating an evaluation form (see Figure

resources, organizational structure, variability and

2, p. 43) to produce a ranking that could be incorpo-

breadth of the audit programs impact. Some questions

rated into the Kano model, which provides a needed

that determine whether an audit program has the nec-

framework for evaluating the service of an internal au-

essary resources are:

dit program.

Are there enough auditors to complete the number

of comprehensive audits required within the given

Evaluation forms


The evaluation form assesses critical areas of an audit

program, and it weights audit planning as the largest

Do auditors have the experience, skills and education to evaluate the areas theyre auditing?

component, allotting it 40% of the base score. Planning

Is the required infrastructuresuch as office space,

is a critical element in any endeavor, ensuring all as-

computers and suppliesneeded to manage the

pects of an organization that must be monitored are

program in place?

consistently reviewed, and the evaluation form awards

points for conducting the audits as scheduled. After all,

Is there a budget for travel if off-site audits are required?

Are there authority and management support to con-

Kano model

duct audits?


After a base score has been attained, you will evaluate how the audit program provides value beyond


verifying compliance and fulfilling requirements. This

gives the program credit for acting on opportunities for

improvement (see Table 1). If those opportunities had
potential financial savings attached to them, the audit


program received additional points.

(excitement factors)

Primary satisfiers


(basic requirements)

40 QP

The next step is called the reality check (see Table

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


findings from the previous year. An organization also

should include repeat findings that resulted from an
external audit.

Points added for value-add

findings / TABLE 1

These points are added or subtracted from the base

score (see Tables 1 and 2) using a five-point rating
Five is very good or the best possible.
Four is above average.
Three is minimally acceptable.

Value add



Observation that lead directly to $1,000+ lean savings.


Observation that lead directly to $1-$1,000 lean savings.


Two needs improvement.

Opportunity for improvement that is implemented by area


One is very poor.

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

Points deducted based on results

of external audits / TABLE 2

minimally passing and 90% or greater (a minimum rating of three out of five in every category) is considered
excellentor delightful on the Kano model.

Reality check


Each major finding against audit program from outside audit.

Each major finding from outside audit that was previously

identified internally.

Each major finding against quality management system from

outside audit.

resources needed to carry out the mandates of their

Each minor finding against audit program from outside audit.

programs. After an organization defines its ratings,

Each repeat finding from previous year.

This assessment model allows an organization to

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

the model should be consistently applied to provide

results that can be analyzed and used as input to the
continuous improvement program.

After my audit program went through this rating

The audit cycle

process, I looked at the score and found the initial rat-

An audit program manager (APM) develops plans

ing reflected my first impression of the program when

based on organizational, site and audit program goals,

I arrived at the site. The improvements I made during

which include various aspects of compliance, improve-

my first year resulted in a better score, and it supported

ment and risk management. The APM may receive indi-

my anecdotal and subjective opinion of the programs

vidual audit plans for review and approval, but this de-

status at that time.

pends on an organizations policy and the experience

of the lead auditor.
The APM drives the audits execution phase by pro-

The evaluation forms elements were chosen because theyre as objective as possible and likely to be
consistent on a yearly basis.

viding policies, procedures, resources and credentialing requirements, and he or she will include this in the

Other factors

auditors assignments. APMs receive reported audit

Note that there are other important measures of an

results from lead auditors, and they analyze those find-

audit programs success not included in this model.

ings and report them to site management.

This is because there are factorsbeyond how robust

Responses to the audit are included as input in de-

an audit program isthat might be involved in its im-

velopment of future plans. This entire cycle (see Online

provement: for example, a yearly reduction in custom-

Figure 1, which can be found on this articles webpage

er audit findings.

at is repeated with momen-

Other possible reasons for improvement that are

tum from ongoing revisions of goals and objectives,

unrelated to an audit programs performance include:

including analysis of data provided by the audit results.

different auditors, stricter clients, improvement in the

September 2015 QP 41

quality management system or luck of the draw (an au-

components to meet your organizations needs, and use

dit only takes a sample after all).

it as an assessment of your assessment program. QP

Even other factors, whether theyre minor or major,

can contribute to a reduction of internal audit findings,

1. Kano Model Tutorial,,

and its difficult to consistently quantify monetary savings from findings.

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


Here is an example of how to assess an audit program based

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

42 QP

LANCE B. COLEMAN SR. is a quality engineer and lean

program coordinator at The Tech Group in Tempe,
AZ. Coleman holds a degree in electrical engineering technology from the Southern Polytechnical
University in Marietta, GA. A senior member of ASQ,
Coleman is an ASQ-certified quality engineer, Six
Sigma Green Belt, quality auditor, biomedical auditor
and an Exemplar Global quality management system
principal auditor. Coleman is the author of Advanced Quality Auditing: An
Auditors Review of Risk Management, Lean Improvement and Data Analysis
(ASQ Quality Press, 2015). He is an instructor for ASQs quality auditor
certification refresher course and is the newsletter editor for ASQs Lean
Enterprise and Audit Divisions.

Before beginning a root cause and corrective action process analysis, the consultant rated ABCs internal quality audit
program to provide an objective baseline for comparison after
improvements were implemented. Figure 3 (p. 44) shows the
results of the assessment. A score of 60 is minimally acceptable,
80 or better is the goal and a score of 90 or higher is delightful.
With a rating of 23% (based on the information from ABCs
records), ABCs audit program was in the dissatisfaction quadrant
of the Kano model (see Online Figure 2, which can be found on
this articles webpage at
The next year, the following changes were implemented:
Two new auditors were trained, and one worked on off shifts.
Two of the existing auditors received refresher training.
Portions of two audits were conducted during off shifts.
The standard operating procedure for audits was completely
Audit forms were revised, and auditors were trained to address previously cited deficiencies.
These changes led to the following results from subsequent
customer audits. There were no major audit findings against the
quality management system, and there wasnt any nonconformance issued against the audit program itself. Figure 4 (p. 45)
shows the results of the following years audit program evaluation.
The improvements made to the audit program were substantial, and as expected, they were reflected in the greatly improved
score. The new rating was more than three times greater than the
original scorewell above minimally acceptable requirements
and within the margin of error for attaining the goal of 80%.
The score was in the must-be quadrant of the Kano model
(see Online Figure 2). There were still improvements that could
be made, and some areas low scores could easily be used as
a roadmap for improvement and delightful performance in the
future. L.C.


Audit system evaluation form


Audit system evaluation

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

Subtotal = potentially 100%

Value add percentage

Reality check percentage


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

September 2015 QP 43

Organization ABCs pre-improvement evaluation


Audit system evaluation

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

44 QP


Organization ABCs post-improvement evaluation


Audit system evaluation

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

September 2015 QP 45

Looking back at the Ishikawa
familys contributions to
qualitys heritage

In 50 Words
Or Less

Ichiro Ishikawa and

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


and special about the contributions the Ishikawa family
made to the global quality movement and its advancement in the development and applications of quality
thinking and methods.
Kaoru Ishikawa (1915-1989) is universally known and
revered within the quality community. Lesser known are
the significant contributions made by his father, Ichiro
Ishikawa (1885-1970), to the establishment of a modern
quality movement in the period after World War II.


by Gregory H. Watson

This article provides the history of these contributions by the Ishikawa father and son duo and positions
their contributions as important components in establishing a foundation for Japanese total quality management (TQM).

Exceptional father
The Ishikawa familys roots are in Tokyo where Uichiro
Ishikawa (1862-1919), father of Ichiro Ishikawa, managed the Kanto Sanso (Kanto Acid and Soda) company.
September 2015 QP 47

After Ichiro Ishikawa graduated from the Imperial

During these pioneering years of JUSE, Ichiro Ishika-

University of Tokyo and served there as an assistant pro-

wa played an important role in convincing senior manag-

fessor in applied chemistry for several years, he joined

ers of major Japanese companies to pursue quality as a

his fathers company to begin a long management ca-

top-priority strategy for the reconstruction of Japanese

reer in the Japanese chemical industry, where he even-

industry. In recognition of his lifetime contributions to

tually became an industry leader during the war years

Japan and its industry, Ichiro Ishikawa was decorated

and served as president of Nissan Chemical Industries

with the Grand Cordon of the Order of the Paulownia

and director of the Japanese Association for Chemical

Flowers of the Rising Sun by the emperor.

Ichiro Ishikawas role as JUSE chairman was not

Following this period, he transitioned into a cross-

merely an honorary position without real responsibility.

industry leadership role; first as chairman of the Japan

His focus was to convince Japanese business leaders of

Industrial Association (JIA) in 1946, and then as the first

their responsibility to pursue quality as a key business

president of the Keidanren (Japanese Federation of Eco-

objective for the recovery of Japans economy during the

nomic Organizations, or JFEO), a position he held from

postwar reconstruction years. In many ways, he acted as

1948 to 1956.

the kuroko, or the player who is dressed in black clothing

When the Union of Japanese Scientists and Engineers

in Japanese kabuki dramas to facilitate the actions on

(JUSE) was established in mid-1946, the executive com-

the stage by the primary actors who are the visible focus

mittee was initially organized with Yoshitomo Tatumi

of the onlookers.

as the founding president. From the start, it was JUSEs

My belief in Ichiro Ishikawas role has been deduced

intention to maintain a close relationship with industry

through a logical examination of evidence presented

by inviting a recognized leader to serve as its chairman.

through the Deming Prize records.

JUSE top management then invited Ichiro Ishikawa

The effectiveness of Ichiro Ishikawas interventions

to serve as its initial chairman. On July 20, 1947, he met

and a measure of his influence has been solidified by the

with Kenichi Koyanagi, the first managing director of

fact that he served as the first chairman of the Deming

JUSE (1946-1965), and accepted the nomination. Since

Prize Committee (established in 1951) and at the first

the initial installation of Ichiro Ishikawa as the founding

Deming Prize Award Ceremony in September 1951. There,

JUSE chairman, JUSE has traditionally requested that

the Deming Application Prize was awarded to four major

the chairman of the Keidanren or JFEO serve concur-

Japanese organizations: Fuji Iron & Steel Co., Showa Den-

rently as its chairman based on this precedent.

ko K.K., Tanabe Seiyaku Co. and Yawata Iron & Steel Co.


Career milestones
President, Japanese
Assistant professor,
Society for Quality
faculty of engineering,
Control (two-year
University of Tokyo.
BORN: JULY 13, 1915



Doctorate, department
of applied chemistry,
faculty of engineering,
University of Tokyo.

48 QP


President, Musashi
Institute of Technology
(currently Tokyo City

1974 1976 1978 1981

Professor, faculty
of engineering,
University of

University of
University of

Academy for
Quality (IAQ),

QC Circle Koryo, General

Principle of the
QC Circle, QC Circle
Headquarters, Union
of Japanese
Scientists and
Engineers (JUSE).



What Is Total
Quality Control?
The Japanese
Way, Prentice
Hall Inc.


Guide to Quality Control (fourth edition),

Asian Productivity Organization.

in English


In the following year, eight additional organizations

leaders involved in industry and academia is clear when

received this award: Asahi Chemical Co., Furukawa

examining the list of individual awardees of the Deming

Electric Co., Nippon Electric Co., Shionogi & Co., Shion-

Prize in 1952. Seven members of the JUSE Quality Re-

ogi & Co., Takeda Chemical Industries, Toyo Spinning

search Group, chaired by Shigeru Mizuno, were recog-

Co. and Kyushu Cloth Industry Co.

nized with this award: Tetsuichi Asaka, Kaoru Ishikawa,

During the remainder of Ichiro Ishikawas tenure as

Masao Kogure, Masao Goto, Hidehiko Higashi, Shin Mi-

JUSE chairman, three to four organizations received

ura and Eizo Watanabe. Encouraging these individuals,

this award each year. Many of these recipients came

and, in particular, Ichiro Ishikawas son Kaoru Ishikawa,

from the chemical industry, and were major Japanese

to dedicate their intellect and energy to developing qual-

organizations that you would expect to be active in the

ity in Japan was an exceptionally important strategy that

Keidanren, or were critical infrastructure industries that

led to efficient management.

were necessary for the reconstruction of a broad-based

While my arms length observations of the actual activ-

manufacturing capability for rebuilding the Japanese

ities of this time are perhaps not totally accurate, it seems


there was a strong role for an executive leader of the stat-

In the year following his term as chair, there were no

ure of Ichiro Ishikawa to serve in a persuading way to

Deming Prize Award recipients. While no strong conclu-

engage industry and individuals to support Japans fledg-

sion can be drawn from this information, it appears that

ling quality movement. It is clear, however, that the father

there might have been an invisible hand operating be-

influenced his son to serve in this capacity. Perhaps, in

hind the scenes that caused company executives to pur-

the future, a researcher will search the JUSE archives to

sue quality in the same way as Adam Smiths invisible

determine the validity of this personal belief.

hand guides the benefits to the whole of society based on

Exceptional son

the actions of an individual.1

Another component of Japans quality effort was the

I have expressed my deep respect for the contribu-

engagement of top-level executives, which was combined

tions of Kaoru Ishikawa in an earlier article2 in which

with a strategy adopted by JUSE of providing knowledge

I explained how my initial introduction to quality came

and expertiseexternally through the lectures by qual-

through the study of his approach to reviewing projects

ity gurus W. Edwards Deming and Joseph M. Juran, and

for quality improvement in a series of videos produced

through developing internal experts on quality.

by Hewlett-Packard in the early 1980s.

Evidence of this strategy to get Japanese thought

Introduction to
Quality Control
(third edition),
3A Corp.


Although I never met him, Kaoru Ishikawa became a

Blue Ribbon Medal

of Honor, Japanese
Eugene L. Grant
Award, ASQ.

Walter A. Shewhart
Medal, ASQ.

1952 1971 1977 1982 1983

Deming Prize
for Individuals,
Deming Prize

Honorary Member,
Japanese Society
for Quality Control.


Establishment of
the QC Circle Kaoru
Ishikawa Award, QC
Circle Headquarters,
Honorary member, IAQ.

1986 1987 1988 1990 1993 1994 2007


Order of Sacred
Treasure, Gold
and Silver Star,

of the Kaoru
Ishikawa Medal,

DIED: APRIL 16, 1989

of the Founders
Medal, IAQ.


Honors and awards

For more information about Kaoru Ishikawas life compared to the parallel development of quality control, see
Postscript: A Parallel Chronology of Dr. Ishikawas Life
and Japans TQC at

September 2015 QP 49

virtual mentor to me because I realized how profoundly

systemic effects of quality and its cultural adaptation

he shaped how I formulated my own approach to quality

by focusing on the core components that are universal

consulting. He has greatly advanced the development of

elements and may be applied in any industrial concern

quality by managing its transition across generations and

or cultural context.
Kaoru Ishikawas professional life was dedicated to

across cultures.
Through the development of a collective system of

developing and guiding the fledgling Japanese quality

qualitytotal quality management (TQM) the Japa-

movement and sharing with the rest of the world the les-

nese wayhe demonstrated an appreciation for the

sons learned during its quality journey.



This year, Kaoru Ishikawa would have turned 100, and Japan is

mittees, along with the three non-Japanese recipients of the W.

honoring his legacy.

Edwards Deming Distinguished Service Award for Dissemination

In recognition of this anniversary and to memorialize his

lifelong quality career, the Union of Japanese Scientists and
Engineers (JUSE) has joined with the Japanese Standards As-

sociation (JSA) and the Overseas Human Resources and Industry

Development Association (HIDA) and others in a Birth Centenary
Commemoration Project. This project is resolved to preserve

and communicate his legacy and exceptional contribution to the

quality movement that had substantial impact on the industrial
management in Japan and the rest of the world during his illustrious career.
This project has two objectives:
1. Transfer Kaoru Ishikawas achievements and philosophy to
the next generations around the world.
2. Demonstrate how his philosophy, ideas, methods and activities can be effective today and will continue to be relevant
Three major activities are planned this year:
1. The 1993 book Kaoru IshikawaThe Man and Quality Control,

and Promotion of Japanese Total Quality Management (over-

seas): Janak Mehta (India), Kan Trakulhoon (Thailand) and the

author of this article (United States and Finland), who was the
first recipient of this award.

Some of Kaoru Ishikawas accomplishments include:

Founding the Japanese Society for Quality Control (JSQC) in
1970 with Shigeru Mizuno and Tetsuichi Asaka with Yasusaburo Hara as its first president.
Establishing JUSE and JSQC programs for the Deming Prize,
three monthly academic journals on quality, and various
quality conferences and symposiums, which continue to be
Founding the International Academy for Quality with Armand
V. Feigenbaum (United States) and Walter A. Masing (Germany).
Organizing international activities for quality circles (QC). He is
known as the father of the QC.
Kaoru Ishikawa served as the leader of overseas QC study

published by Keiko Ishikawa, Kaoru Ishikawas widow, has

teams of Japanese executives and contributed to international

been translated into English by a number of volunteers and is

cooperation in quality control under the sponsorship of various

now available for download at:

Japanese organizations.

2. A new collection of papers about Kaoru Ishikawa will be published electronically on the same JUSE website.
3. A commemorative symposium Sept. 28 at the University of

He visited China, Taiwan, Korea, Thailand, India, the United

States, Czechoslovakia, Finland, France, Sweden, Switzerland,
Brazil and the United Kingdom to conduct seminars and conferences to transfer Japanese TQM to other countries. He wrote 31

Tokyo to celebrate the centennial anniversary of his birth.

books and more than 600 papers on various topics related to

The chairman of the executive committee is Noriaki Kano,

quality. G.H.W.

Kaoru Ishikawas principal disciple and an honorary member of

ASQ. Serving as vice chairs are Ichiro Kotsuka (Managing Director
and Secretary General, JUSE) and Kazuyuki Suzuki (past President of the Japanese Society for Quality Control).
In addition, many Japanese business leaders and former
students of Kaoru Ishikawa are members of the organizing com-

50 QP

For more information about Kaoru Ishikawas teachings, see these ASQ open-access
Kondo, Yoshio, Kaoru Ishikawa: What He Thought and Achieved, a Basis for Further Research, Quality Management Journal, July 1994, pp. 86-91.
Watson, Gregory H., The Legacy of Ishikawa, Quality Progress, April 2004, pp. 54-57,


Furthermore, through his own writings and publica-

faith. In this tradition, each person should leave the

tions and through the research that he encouraged oth-

world a better place as a way of honoring the wisdom

ers to pursue, Kaoru Ishikawa assured that learnings

that has been gathered by ancestors, by passing on and

from Japan would be transferred to the West because

preserving this knowledge for future generations.

the Japanese TQM research and study committees of the

Each person will contribute to the continual cultiva-

1980s translated their final reports into English to share

tion and nurturing of this knowledge to create an ever-

with the rest of the world.

more refined state of being. The responsibility of each

of us is to leave the world a better place as a result of

Collaborative leadership

our experience as humans. Perhaps this implicit cultural

It also is clear that Kaoru Ishikawa was not solely re-

mindset of Japanese thinking is best described in a guid-

sponsible for all of these results. Early development of

ing precept of Japanese business:

quality in Japan was indeed a collaborative effort. The

Contribute to developing the welfare of the country

founding generation of Japanese quality thought leaders

by working together, regardless of position, in faithfully

included three men who served as prime movers within

fulfilling your personal duty and show gratitude for the

the early Japanese quality community: Shigeru Mizuno,

contributions of others in things that are both great and

Tetsuichi Asaka and Kaoru Ishikawa.

small; in both thought and deed. In such a system of liv-

Shigeru Mizuno led the initial Quality Research

ing, the responsibility of each generation is to develop

Group, which interpreted the words of Deming and Ju-

the following generation so that it is capable of fulfill-

ran to help structure a uniquely Japanese approach to

ing its own responsibility and extending the tradition of

companywide quality control.

learning and doing.

Tetsuichi Asaka served as a consultant and quality

This was accomplished by Kaoru Ishikawa because he

coach who guided Japanese industry leaders and their

was a mentor for a second generation of Japanese qual-

companies in a disciplined approach to quality.

ity thought leaders: Yoshio Kondo, Takanori Yoneyama

Kaoru Ishikawa contributed to the development

and Genichi Taguchi. The current generation of Japanese

of quality methods and shaped the formal structure of

quality thought leaders also have been his disciples, stu-

Japanese quality infrastructure through his leadership in

dents or colleagues. They include Hitoshi Kume, Noriaki

JUSE and development of a national and global structure

Kano, Shoji Shiba and Yoji Akao.

for the encouragement and promotion of Quality Control (QC) Circle activities.
Kaoru Ishikawa became Japans representation when
speaking about quality through his international activities and by interpreting the Japanese total quality philosophy, tools, methods, success stories and case studies.

In this way, from one generation to the next, the

Ishikawa family contribution has enriched the global
quality community and, in turn, improved the quality of
life for much of humanity.
Exceptional father, exceptional son: Quality professionals remember your contributions and thank you with

His achievements in global quality consulting, backed

deep gratitude for your gifts to our current knowledge

by the exceptional performance of Japanese companies

and capability, which would not have been achieved

that were supported by his national quality colleagues,

without your diligent efforts. To paraphrase Isaac New-

created Japans strong reputation for quality perfor-

ton, If we have been able to see further, it is because we


have stood on the shoulders of giants. QP

This collaborative approach to quality has served Japan well. Clearly, the pivotal role in the global dissemination of Japanese quality was the key personal contribution of Kaoru Ishikawa.

The ongoing legacy

New science is built on the contributions of past scientists. The same is true in the global quality movement.

1. Adam Smith, The Wealth of Nations, 1776.
2. Gregory H. Watson, The Legacy of Ishikawa, Quality Progress, April 2004,
pp. 54-57.

GREGORY H. WATSON is chairman of Business Excellence

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

What is the responsibility of one generation for the next?

This question is a focus that is inherent in the Shinto

September 2015 QP 51


Get Involved!
Your Success
A time to show efforts
and achievements!

Spread the Word

Learn From Others

Raise the global voice

of quality!

Join the celebration!




Where Do You Fit?

Updating the U.S. Standard Occupational Classification System
MANY READERS may not be familiar

U.S. censuses. This disparity prompted a

used to determine which occupations are

with the U.S. Department of Labors Stan-

partnering of ASQs Measurement Qual-

included in the majority of those publica-

dard Occupational Classification (SOC)

ity Division, the National Conference of

tions. One of the major publications used

System. According to its website, the SOC

Standards Laboratories International and

by educators for this purpose is the Oc-

is a:

the Measurement Science Conference to

cupational Outlook Handbook (OOH). The

create a submission for calibration and

following is from the OOH Teachers Guide

system used by federal statistical agencies

metrology job titles and descriptions to be


to classify workers into occupational catego-

added to the 2010 SOC.

ries for the purpose of collecting, calculating

or disseminating data. All workers are classified into one of 840 detailed occupations
according to their occupational definition. To
facilitate classification, detailed occupations
are combined to form 461 broad occupations, 97 minor groups, and 23 major groups.
Detailed occupations in the SOC with similar

Unfortunately, SOC administrators ulti-

The Occupational Outlook Handbook (OOH)

mately rejected this submittal on the basis

is an online career guidance resource that

of insufficient substantiation of:

provides information on hundreds of occupa-

1. Unique tasks performed

tions in the United States. Updated every

2. Sufficient population numbers warranting recognition in the SOC.

Because the SOC does not contain job

job duties, and in some cases skills, educa-

titles and descriptions for calibration and

tion, and training, are grouped together.1

metrology practitioners, there are

two years by the Bureau of Labor Statistics,

the OOH allows students to explore different
aspects of occupations by clicking on the
following tabs:
What workers do on the job.

essentially no standardized

Discovering disparity

definitions for these oc-

The SOC is updated about every 10 years

cupations. Standard-

(the last update was in 2010), with the

ized occupational

next update slated for 2018. I first became

definitions are used

aware of the SOC in 2002 when I was look-

to homogenize titles

ing for demographic information regarding

and descriptions

the population of calibration and metrolo-

across civil and

gy practitioners in the United States to es-

governmental con-

timate the number of potential candidates

tracts, pay grades

who may elect to become certified if an

scales and position

ASQ calibration and metrology certifica-


tion program existed. The numbers were

It is also important

needed to justify a proposal for creating

to note that to assist

the program. The proposal was eventually

young adults in making

accepted by ASQs Board of Directors and

well-informed career

culminated in the creation of the certified

decisions, educators

calibration technician program in 2003.

frequently reference the

After examining the SOC, I learned it

U.S. Department of Labor

does not recognize job titles and de-

publications to provide

scriptions for calibration technicians,

information about oc-

calibration engineers or metrologists,

cupations and forecasts

which means information about these

on future job growth. The

occupations is not being collected via

SOC listing is frequently

September 2015 QP 53


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

Standard Occupational Classification

System search / FIGURE 1

Projected employment change and job
prospects from 2012 to 2022.
Similar occupations.
Contacts for more information.

Quality Engineer

As a teacher, you are in a position

to help your students plan their future.
Through the OOH, students can access
valuable occupational information that
can help them make career choices. By
familiarizing yourself with the features of
the OOH, you will be in a position to quickly

Results for quality engineer


and effectively help your students use this

valuable tool.2

Many, such as those in the calibration

and metrology fields, are faced with large
numbers of baby boomers retiring from
the workforce along with a critical short-

Results for quality technician


age of young adults entering the field. It

is this dire situation that prompted a new
submittal of calibration and metrology
titles and job descriptions for inclusion
in the 2018 SOC, taking into consideration lessons learned from the 2010
submittal. It is anticipated that later this
year, the U.S. federal register will publish
the SOCs decision on adding calibration
and metrology occupations for the 2018
yields a single result, shown in Figure 2.

quality profession, and arguably, this

A query of the SOC website for quality

warrants a call for action by ASQ leaders

Bigger quality picture

technician yields two results, shown in

to rectify this disparity. QP

Some readers may be asking what the

Figure 3.


SOC position on inclusion of calibration

Furthermore, the alphabetical list of

and metrology job descriptions has to

SOC occupations does not list job titles

do with mainstream quality occupations.

or descriptions for quality engineer,

To answer that question, all you need to

engineer, quality, quality technician,

do is search the SOC website for quality

and technician, quality. You can deduce

engineer, shown in Figure 1. The search

the implications of this situation on the


Read more Measure for Measure columns by Christopher L. Grachanen

and other metrology experts by visiting the Departments & Columns tab

54 QP

1. Standards Occupational Classification System, Bureau
of Labor Statistics, U.S. Department of Labor, www.bls.
2. Bureau of Labor Statistics, U.S. Department of Labor,
Teachers Guide, Occupational Outlook Handbook,

a distinguished technologist and
operations manager at HewlettPackard Co. in Houston. He earned
an MBA from Regis University in
Denver. Grachanen is a co-author
of The Metrology Handbook (ASQ
Quality Press, 2012), an ASQ fellow,
an ASQ-certified calibration technician and the treasurer of
the Measurement Quality Division.

Subscribe to Standards Connection

The ISO 9001 revision will be published this month. Dont be caught unprepared.
Standards Connection will keep you a step ahead. By subscribing to Standards
Connection, youll receive expert advice on ISO 9001:2015, exclusive videos from
ASQs Standards Channel, the monthly Standards Connection e-newsletter, and
answers to your burning standards questions. Best of all, subscribing is free and easy.

Subscribe today at






The Global Voice of Quality




Who Cares?
A brothers lesson resonates in doing jobs right the first time
A SOLID WORK ethic is especially impor-

first time. On this occasion, he was in a

workers. What happened to doing a job

tant for anyone in the quality profession.

hurry and didnt bother to use fall protec-

right because its the right thing to do?

Because the word quality is in your job


What about taking pride in your work?

I realized some people never learned

title, people hold your quality of work to a

He ended up accidently stepping on a

higher standard. This is true for big things,

fiberglass skylight and falling 30 feet be-

the importance of a work ethic. I learned

of course, but also for day-to-day items.

fore an upward-facing handle of a butterfly

that lesson early in lifehelping my

valve impaled his lower leg. If that valve

brother fix his run-down, old car.

Do you follow up on tasks and track

them to completion? Do you proofread

had been mounted just a few inches lower,

emails before hitting send? Do you take the

hed have died instead of just being injured.

time to really understand the documents

Another time, a worker was dispatched

Setting the example

When I was in grade school, my brother

you sign? Do you show up and choose to

to the manufacturing floor to weld a leak-

Craigs first car was a clunker he borrowed

be present in the meetings you attend? All

ing catch pan. When I went to verify the

from my grandfather. It was 1954 Pontiac

of these things send a message about you

job was complete, I saw a quality of work

that had been rusting in a barn. The deal

as a quality professional, and they either

that wouldnt have survived the scrutiny of

was: Craig could use it as long as he liked,

bolster or tarnish your image.

my eighth-grade shop teacher. Besides the

but he had to return it in working condition.

I once worked in a 60-year-old manu-

hideous, wandering weld bead, there were

It didnt take long to see hed gotten a

facturing facility. In its heyday, it was

visible holes in the seam, and the pan was

lousy deal. The transmission was on its

state of the art, but when I arrived, it was

still leaking. The workers whod asked for

last leg, the brakes were going and the car

dilapidated. Upper management was unin-

the repair rightly complained that they still

had countless other problems.

terested in investing in it, and that attitude

had a mess to deal with. Nonetheless, the

was reflected in the crews demeanor.

welder had signed off on the work ticket.

One day, a maintenance worker was

Where does this attitude come from?

One evening, I went outside and saw

it in the driveway with an extension cord
snaking from the garage to the car. The

assigned to repair equipment on the roof.

I understood how demotivating upper

1954 Pontiacs had three-on-the-tree gear-

Hed been up there many times to fix the

managements view could be, but these

shifts (one thats mounted to the steering

same piece of equipment, and you have to

examples of laziness affected the safety

column), and there was an issue with the

wonder why it wasnt fixed properly the

of the workers themselves and their co-

linkage. Because the cars inner workings

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

56 QP

fix the actual gearshift problem.

Daylight faded to full darkness, and the

say Ill do something, Ill do itand do it

tive example so I can pass the lesson on to

well. I take pride in that and in the cred-

a new generation. QP

temperature dropped. Our T-shirts were

ibility it builds. Its something that should

filthy and we were shivering. I held the

be intrinsicnot just for quality profes-

light as my brother put lengths of heat-

sionals, but for everyone.

shrink tubing on the wires, and painstak-

These same principles apply on the

ingly twisted a wire back together and

home front. Now that I have my own kids,

soldered it. He slid the heat-shrink tubing

I feel its especially important to set a posi-

DEREK PURDY is a senior quality

engineer at SI-Bone in San Jose, CA. He
holds a masters degree in engineering management from Old Dominion
University in Norfolk, VA. An ASQ senior
member, Purdy has served as membership chair and vice chair of ASQs Silicon
Valley Section. He is an ASQ-certified
quality engineer and quality improvement associate.

over the joint and shrunk it with a hairdryer. He then slid the cloth insulation over
the tubing and held it with electrical tape.
Anyone whos tried holding a soldering
gun to a free-floating wire with one hand
while feeding solder with the other can understand how this felt like a never-ending
I noticed the cuts in the wires were
staggered to prevent the bulge created by
the repairs from piling up in one spot. As
a result, the wire bundle fit back down the
steering column and avoided chafing during operation.
After the job was done, Craig tested the
signals and horn to make sure they worked
properly. It was well past 11 p.m. when we
finished. I looked up and asked, Whyd
you go through all that? Grandpa doesnt
care about this car. Hes just gonna put it

No entrance or comprehensive exams

back in the barn. And youre only driving it

Small, interactive classes

until you get something else anyway.

Accelerated, accredited degrees

Doing the right thing when someones

watching is no big deal, Craig said. Its
what you do when nobodys looking that

Degrees include options for LSS


counts. This isnt my car. Grandpa just let

Innovative, project-based learning

me borrow it. And I agreed to take care of

Weekly interaction with faculty and

fellow students

it. That means returning it at least in the

same condition as I got it. Take pride in your
work; if youre going to do a job, do it right.
Im certain Ive heard that advice many
times before and sinceif its worth doing, its worth doing well. But having such
a naked display of integrity at an early
age helped drive the message home with
greater force than anything I experienced
This early lesson has served me well in
my personal and professional life. People
tell me they appreciate knowing that if I

Scholarships available for qualified

Transform yourself.
Become a leader in your industry.
NGS offers innovative, flexible
degrees designed to support your
professional success and
development. One-on-one interaction
with faculty and support staff ensure
that you wont get lost in the crowd.
Ask about our reduced tuition rates for ASQ members.

Bachelor of Science Degree Completion*
10 courses over 12 months - Courses start October 6
Call Karen at (800) 838-2580 ext. 125 to learn more

Master of Science Degree

12 courses over 12 months - Courses start October 7
Call Trish at (800) 838-2580 ext. 104 to learn more

Doctor of Business Administration*

16 courses over 30 months - Courses start October 22
Call Lisa at (800) 838-2580 ext. 166 to learn more

NGS is accredited by the New England Association of Schools and

Colleges, Inc. through its Commission on Institutions of Higher Education.
Certified to operate by the State Council of Higher Education for Virginia


Success you can measure
(800) 838-2580 | |

*Not available in MA. Not available to MA residents.

September 2015 QP 57



Truth Detective
Tips for investigating prospective employers, avoiding duds

truly valued integrity. CEO intervention

advanced search feature and select the

you dont want to end up working for

will be required to improve ethical deci-

past company category to find people

an organization thats a dud. The U.S.

sion making, and dont delude yourself

who previously worked at the organiza-

by believing you would be immune.

tion. View each profile to get a sense of

unemployment situation has improved,

and the tables are turning back in favor

CheapTheres not much value in tak-

of employees. Even people whove ex-

ing a job if youre not going to receive

employers, use the location, title or other

perienced long-term unemployment are

the resources you need to accomplish

criteria to narrow your search to a par-

re-engaging in their job hunts.

anything meaningful. Research the orga-

ticular department. Good signs include

nizations finances and look for signs of

long stays, promotions and people who

tions as part of employee recruitment

poor pay or a lack of funds. A CFO or

left but came back. Its a bad sign when

and retention. Here are four potential

CEO might be able to reverse the situa-

you see a high number of people who

tion, but few others can.

worked there less than a year.

Employers must consider their reputa-

problems you should investigate at any

organization thats offering you a second-

Bad cultureSymptoms of a bad cul-

how long they stayed there. For large

Interview past employees. You can

round interview:

ture appear in many forms. Its possible

send messages to previous employees via

High turnoverThis can be the result

that people are too busy creating fief-

LinkedIns InMail feature, and ask about

of multiple issues. A strong HR leader

doms that inhibit change, or everyones

their experience at the organization.

might be able to fix a turnover problem

input is required, creating meeting after

Theres a pretty low chance of getting a

but only with sustained support of the

meeting and preventing anything from

response. Few people want to badmouth


being accomplished. Poor ethics and fi-

a previous employer, and you can assume

nances may contribute to a bad culture,

a lack of response means the organiza-

organizations leadership will trickle

too. It can cause employees to blame

tion is below average. On the other hand,

down. If you see poor ethical decisions

others for their problems rather than

if you hear back from someone, you may

being made, theyre likely happening

rolling up their sleeves and collaborat-

receive make-or-break information you

throughout the organization. Lower-

ing to reverse the bad situation. Unless

couldnt get elsewhere.

level employees practicing unethical

youre the CEO, youre not going to fix a

behaviors would be fired if their leaders

bad culture.

Poor ethicsThe ethics of an

Check out the organization on Google

Finance or Yahoo Finance. If you dont
know how to read corporate financials,

Uncovering the

ask someone who doeshaving an

Use LinkedIn to see

organization experiences financial highs

how long people stay

and lows. If it doesnt look good, work to

there. When recruiters

understand why theyre in that situation

look at rsums and

and what it would take to change it.

see a string of short

Read employee review sites such

employment stints, they

as Glassdoor and Indeed. Again, most

assume the person is

people will avoid badmouthing a previ-

a job hopper. LinkedIn

ous employer. When someone does, you

gives us the power to

should take note, but read the reviews

turn the tables and

carefully. They may have been faked or

understand an organiza-

embellished. Some HR departments have

tions turnover rate.

been known to post favorable reviews

Use LinkedIns

58 QP

outsiders perspective can help. Every

of their organizations. Although they

work there, too, its a bit disingenuous.

regulatorssuch as the Federal Avia-

If youre a CEO, CFO or board mem-

Conflicting reviews also may reflect that

tion Administration, National Oceanic

ber, investigate your organization. As the

some employees had good bosses and

and Atmospheric Administration, or

game of talent acquisition heats up, you

others didnt.

U.S. Securities and Exchange Commis-

dont want to be left on the sidelines. QP

Read customer review sites such as

sion. Our organization provides staffing

Yelp, Google and the Better Business Bu-

for U.S. Food and Drug Administration

reau (BBB). On these sites, customers air

(FDA)-regulated businesses. We check

their complaints and report issues with

prospective partners for warning letters

an organizations products or services.

and recalls on the FDAs website (or

Picture yourself working at that organiza-

U.S. Department of Agriculture for food

tion, and distinguish between complaints


you would be in a position to address

Some organizations will view a recall

versus ones that would be out of your

or warning letter as a call for improve-

control. When the BBB receives com-

ment, which is good. Others will see it as

plaints, it contacts the chief executives at

government overreach that they must

each organization. On the BBB site, if you

comply with, which is bad. We do not

see a slew of issues that werent resolved

recommend directly raising an issue in

to the customers satisfaction, theres a

an interview. Instead, ask questions that

problem at the top of the organization.

will uncover whether the organization is

Search industry regulators websites. Every industry has its own set of

1. Employment Situation Summary, Bureau of Labor Statis-
tics economic news release,

organizational communications
consultant and the president and
CEO of MEIRxRS, a family of science,
technology, engineering and math
recruitment and staffing organizations in Glendale, CA. She has a
masters degree in communication
management from the University of Southern California in
Los Angeles. Christopher is an ASQ member and past chair
of the ASQ Food, Drug and Cosmetic Division.
PAUL DIONNE is a business developer
for MEIRxRS in Glendale, CA. He holds
an MBA from Boston University in

handling its current situation, and how

its going about it.

ASQ Standards
Channel: All You
Need to Know About
ISO 9001:2015
Find pertinent answers to your burning
ISO 9001:2015 questions on the new
ASQ Standards Channel.
30-plus informational video interviews
with top experts
Free for ASQ members

Sponsored by

ASQ-V0015 Filler HalfHz 6.875x4.875_MKG.indd 1

15-03-09 1:49 PM

September 2015 QP 59



Blocking Benefits
Including nuisance factors during experimentation
WHEN CONDUCTING even a seemingly

millimeters. Thirty flakes were toasted,

in a designed experiment when it should

simple experimentsuch as one with

measured at five locations, and the aver-

be included, you could obtain erroneous

a single factor with several levelssig-

age of all 150 thicknesses was used as the

conclusions about the factor of interest. In

nificant care and consideration should

response. The factor of interest is toast-

addition, if the blocking factor was used

go into the design setup. It is rare for

ing time, and four times are considered

in the experiment, but the wrong analy-

the response of interest to be influenced

(in seconds): 20, 40, 60 and 80.

sis carried out, you also could reach the

only by one factor under study during the

actual experimentation.
There could be a number of other

Three replicates for each toasting

time were obtained while randomizing

wrong conclusion about the factor of interest. Lets look at the latter a little closer.

the times. You want to know whether

factors affecting the response if not

toasting time has a significant effect on

ANOVA activities

controlled or included in the experi-

flake thickness. In other words, is there a

Given the designed experiment discussed

ment. Those factors that are not the main

statistically significant difference among

earlierwith four toasting times and

factors of interest but could influence

the toasting times?

three ovensa total of 12 average thick-

the response are often referred to as nui-

nesses were obtained, as shown in Table

sance factors. If the nuisance factor can

1. An analysis of variance (ANOVA) was

be controlled during experimentation, it

carried out for the experiment, and the

is often included in the design setup as a

results are listed in Table 2. In this experi-

blocking factor.


If there is only one nuisance factor

The factor of interest is toasting time.

with several levels, you try to carry out a

The goal is to determine whether there

randomized block designgiven the main

is a statistically significant difference

factor (factor of interest) can be random-

among the four times. A final goal may

ized within each level of the blocking

be to determine the optimal or best

factor. If there is more than one nuisance

toasting time.

factor, you may be able to include them in

The oven is a blocking factor because

the design setup as well as using designs,

you think different ovens may influ-

such as the Latin square design. In this

ence the results, but it is not a main

article, the importance of blocking using

factor of interest. That is, youre inter-

one main factor (with four levels) and

ested in picking the optimal oven. You

one nuisance factor (with three levels)

will not determine which oven gives

will be illustrated.

the best results and only use that oven

In this experiment, there were three

and discard the other two.

Corn flakes and ovens

ovens that could be used for toasting,

Suppose youre interested in the thick-

so toasting time could be randomized

which provides evidence there is a

ness of corn flakes after they have been

within each oven. Because ovens may

statistically significant difference among

toasted. Toasting is just one of the

operate differently and possibly affect the

the four toasting times. Toasting time

processing steps of corn flakes for cere-

flake thickness, ovens were treated as a

appears to have a significant effect on

als and can cause several changes in the

blocking factor in the experiment. There

the average corn flake thickness. Some

corn flakes, which in turn could affect the

were other possible nuisance factors at

statistical software packages will report a

consumers view of the cereal.

play, but they were held constant for the

p-value for the blocking factor as well. As

purpose of the experiment.

stated earlier, however, youre not always

Puffiness or thickness is one

response of interest and is measured in

60 QP

If you dont include the blocking factor

The p-value for toasting time is 0.031,

interested in statistical significance of the

Average corn flake

thickness / TABLE 1

Analysis of variance for

corn flake thickness / TABLE 2
Source of variation





Toasting time



























DF = degrees of freedom
SS = sum of squares
MS = mean square
F = (found variation of the group averages)/(expected variation of the group averages)

blocking factor (although this may provide

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

Analysis of variance for corn flake

thickness without ovens / TABLE 3
Source of variation





Toasting time





The correct analysis




Now, carefully consider the importance




cluded in the experiment in the first place.

of blocking and using the correct analysis. Suppose the experiment is run in the
exact same manner (with ovens as blocks
and toasting time randomized within the

DF = degrees of freedom
SS = sum of squares
MS = mean square
F = (found variation of the group averages)/(expected variation of the group averages)

block), but the results are incorrectly

I like to think of the error as a trash

experiment involved ovens, which was the

ovens. Table 3 provides the ANOVA for

can: Its where all quantities go that can-

appropriate design, but the wrong analysis

this situation.

not be assigned to some other factor or

carried out.

analyzed without the blocking factor:

Now, notice that toasting time is not

interactions involved in the experiment.

Any time you can include a blocking

statistically significant with a p-value

Id prefer the error not be large, but that

factor or other factors in the experiment

of 0.134. That is, toasting time does not

it could be parsed into df and SS for other

itself, you should. The next step is to

significantly affect flake thickness. What

factors. That is, when you can identify a

make sure to carry out the experiment as

happened? The degrees of freedom (df),

source of variation, the df and SS can be

planned, and if any deviation is encoun-

sums of squares (SS) and mean square

partitioned into that source (or sources if

tered, it should be recorded and reported.

(MS) for toasting time are identical to the

more than one), and you have a better idea

The type of analysis depends on the actual

previous analysis, but the F value and, of

of what role factors play in an experiment.

experiment conducted. QP

course, p-value differ. These values are not

Because in this case, the error mean

influenced by the addition or omission of

square increased, the overall F value for

other factors (such as ovens).

toasting time decreased (and resulting

The error has changed, however, and

p-value increased)giving the wrong

it is the mean square for error that is used

result that toasting time is not statistically

to obtain the F-value and thus, p-value for

significant. This is the wrong conclusion

toasting time. The error quantities now

because you know the origin of some

include all of the values once represented

of the error quantities: the ovens, which

by ovens. The df and SS for ovens dont

for some reason did not get included in

just disappear, but get lumped in with the

the analysis (I have seen this happen in

remaining error.

practice on more than one occasion). The

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

CONNIE M. BORROR is a professor

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

September 2015 QP 61

Special Advertising Section

Standards and
Auditing Guide

Up-Close Look
Its not always easy to spot the best providers of standards
and auditing-related products and services. Thats why ASQ
has assembled this special section to help you find:


And theres much more to see! Take a look!

If youre interested in appearing in next years guide, email
62 QP

Special Advertising Section

Standards and
Auditing Guide
A2LA American Association for Laboratory

AIAG (Automotive Industry Action Group)

26200 Lahser Road, Suite 200
Southfield, MI 48033
Phone: 248-358-3003

5202 Presidents Court, Suite 220

Frederick, MD 21703
Phone: 301-644-3248
A2LA offers accreditation to and training on ISO/IEC 17025, ISO/IEC
17020, ISO Guide 34, ISO/IEC 17065, ISO/IEC 17043, ISO 15189 and
CLIA requirements.
A2LAs areas of expertise include:
Quality Audits
Continuing Education
Quality Training
Standards Training

AIAG is where OEMs, suppliers and academia work collaboratively

to decrease costs and complexity from the supply chain via global
standards development and harmonized business practices.
AIAGs areas of expertise include:
Continuing Education

Quality Tools and Multimedia

Quality Training
Self-directed Learning
Six -Sigma
Standards Training

Take the Next

Step in Automotive
Warranty Management
Guideline & Training Now Available!
The Automotive Warranty Assessment (CQI-14) Training:
provides a best-practice approach for managing warranty
processes with the consumer in mind.
This one day workshop will train you to use the
assessment tool; provide a warranty process that delivers
best practices; provide suggestions for optional reporting;
and prepare you to be a valuable aid for implementation.

For more information on the Automotive Warranty Management

guideline or training, visit or call us at (248)358-3003.

September 2015 QP 63

Special Advertising Section

Standards and
Auditing Guide
ANSI-ASQ National Accreditation Board
600 N. Plankinton Ave., Suite 300
Milwaukee, WI 53203
Phone: 800-606-5394

600 N. Plankinton Ave.
Milwaukee, WI 53203
Phone: 800-248-1946

Providing accreditation to ISO and industry standards for management

systems; calibration, test, and forensic laboratories; inspections bodies;
PT providers; RMPs; police forensic agencies; and medical examiners.

ASQ has the latest quality standards and standards-related products, all
of which are available at a special discounted price for our members.
Whether youre looking for the most recent version of a standard,
guidance in how best to implement a system, books, articles, training or
education, ASQ has what you need.

ANSI-ASQ National Accreditation Boards areas of expertise include:

Standards Registrars
Standards Training
Other Accreditation
Quality Audits
Quality Training

ASQs areas of expertise include:

Continuing Education

Quality Audits
Standards Training



November 9 10, 2015 | Indianapolis, IN


It is vital to ensure products and services meet customer needs, and
there is no better way to guarantee customer satisfaction than with
quality standards and the guidance provided in management systems.
This new conference from ASQ, the global voice and leader in the
quality community, gives your company the opportunity to showcase
your resources to an invested audience of people passionate about
quality who are looking for guidance to improve business outcomes,
ensure customer satisfaction, and certify to revised standards.
There are several opportunities available, allowing you to maximize
your exposure in front of todays leaders and tomorrows innovators in
quality standards.

64 QP

Interested in being an exhibitor at the

ICQS? Call Lou at 866-277-5666, or
email him at
Target Audience

Quality Assurance Specialists
Quality Engineers
Quality Managers

Membership Application
The Global Voice of Quality

Order Number ________________________

Member Number ______________________

Industry: Healthcare
Government Education
Male Female
Manufacturing Other

Mr. Ms. Mrs. Dr.

/ /
Date of Birth _________________________________

Member Type:
Full $159

The one geographic Section included with Full membership will be determined
by your primary address.*

First Name
Middle Initial
Last Name/Family Name

Business Address
City, State/Province
Zip+4/Postal Code
Home Address
City, State/Province
Zip+4/Postal Code
Area Code/Business Telephone
Area Code/Home Telephone
Preferred Email Address

Which one of the following best describes your title?



Six Sigma
Black Belt
Six Sigma
Green Belt


ASQ does not sell email addresses to third parties.

Mailing Lists
Occasionally ASQ shares its mailing list with carefully selected quality-related
organizations to provide you with information on products and services. Please
check this box if you do not wish to receive these mailings.
Member Referred By:
Member Name

Member Number


To help us understand whats important to you, please tell us the top three
reasons why you became an ASQ member.
Career Development


Certification Pricing

Leadership Opportunities

In-person Networking

 nline Networking/

Involvement in ASQs Cause

Product Discounts

Associate $99


Sections (geographic) may be added to any member type for an additional $20.00
each. Visit for a listing of available Sections.


Company Name
Job Title

Involvement in SRO

PROMO CODE ________________________


Preferred Mailing Address: Home Business



cccc cccc cccc

* Contact ASQ to change your assigned Section.

Forum or Division Selection:

As part of your Full membership, you are granted access to one topic- or
industry-specific Forum or Division. Use the list below to indicate the Forum
or Division name.

____________________________________ _______________

Additional Forums and Divisions may be added for $10 each.

Please indicate in the list below the additional Forums or Divisions you
would like and total the number you have selected.
Aviation, Space and Defense
Chemical and Process Industries
Design and Construction
Electronics and Communications
Energy and Environmental
Food, Drug, and Cosmetic

Human Development and

Lean Enterprise
Measurement Quality
Quality Management
Service Quality
Six Sigma
Team & Workplace Excellence

Additional Forum and Division selections:

______ x $10 = $______________



$ _________

Payment Information
Check or money order (U.S. dollars drawn on a U.S. bank) Make check payable to ASQ.


American Express(Check one)

Cardholders Name (please print)
Card Number

Exp. Date

Cardholders Signature
Cardholders Address

Please submit your application with remittance to:

You may also join online at
or by calling ASQ Customer Care at
P.O. Box 3066
USA and Canada: 800-248-1946
Milwaukee, WI 53201-3066, USA
Mexico: 001-877-442-8726
or fax to 414-272-1734.
All other locations: +1-414-272-8575
New memberships are effective upon receipt of payment. New members receive one year of membership from
the date they join. Members are billed prior to the anniversary date of their membership for next years dues.
Memberships, even those paid by employers, are nontransferable. All prices are subject to change.
In becoming an ASQ member, you have the duty to follow the ASQ Code of Ethics and Society governing documents.

Digital amplifier

any type and size.

Mahr Federals digital IC amplifier, the

Flange Armour pro-

Millimar C1200, allows users to view the

tects flange faces

analog scale and numeric digital readings.


Its display range is 5000 m and reading

site delivery, instal-

resolution 0.1 m.

lation and storage.

The C1200 is powered by rechargeable


One of the main

batteries or an external power supply.

root causes for flange

When battery operated, the compact unit

damage is the use of

is fully portable.

hand tools during the

Operating features are set up using an

fabrication and com-

integrated five-button keypad. Features

missioning stages of

such as unit selection, normal/reverse po-

the product. Flange

larity, measuring range, preset, factor and


tolerance entry are easily set up by visual

flange face defects

menu options. When tolerances are used


the display shows a pass/fail status using

improves production

a green/red color on the backlit display.

performance. Flange Armour also reduces

Call: 800-343-2050.

the need for flange re-facing.

ergy to vibratory energy. The waveguides


Call: 844-693-1073.

are designed to resonate at the frequen-


cy of operation of the power supply and



Flange protection


Flange Armour provides full flange and

Tube drawing system

raised-face protection for industries in-

Sonobond Ultrasonics has re-

volved with the production of flanges of

leased a tube drawing system

The transducer converts electrical en-


designed to
of fine metal
tubing used in
syringe needles. It is also
for medical devices and

used to produce: implantable device

tubing products used in

components; in vitro diagnostic probes;

industries that transport

bands for catheters and guidewires;

critical fluids.

heat-exchanger tubes for controlling

In an ultrasonic system,

66 QP

Ultrasonically drawn fine tubing is

blood temperature during surgery; micro-

a power supply converts

surgical tools; stents; and other devices

line power to high-voltage,

requiring tubing with a fine internal

high-frequency electrical

dimension finish.

power needed to drive the

Call: 800-323-1269.





The Model 4020LT-A two-wire transmitter

Olympus has introduced the Series

from Cosasco provides enhanced resolu-

C industrial videoscope designed for

tion measurements of metal loss due to

inspections of manufactured parts,

corrosion inside pipelines. The transmit-

structures or areas that have limited

ter is designed for operation in plant

direct visual access. The Series C

locations with widely separated monitor-

videoscope features advanced ar-

ing points and a preexisting distributed

ticulation and high-resolution image

control system.

quality. It captures still images and

The Model 4020LT-A features mea-

videos with desired brightness.

surement resolution to 0.1%, allowing a

The videoscopes flexible distal tip

timely response to corrosion rate spikes.

and a proprietary spring neck design

The transmitter has an available NEMA

reduces stress when navigated

4x-rated stainless steel enclosure for op-

through tight bends or sharply curved

series is RoHS compliant and the high-

eration in harsh environments. A switch-

spaces. Articulation is made possible by

peak pulsed laser diode modules operate

able probe-type selector allows users to

the thumb-driven joystick on the unit

typically at a center wavelength.

adjust between different Corrosometer

that controls 360 articulation of the

The SCW 1430 product series are

electrical resistance probe types.

distal tip and up to 120 angulation.

intended for optical testing applications

Call: 800-635-6898.

A protective replaceable cap added

to the distal end tip of the insertion tube

where high-peak pulsed optical power

is required. The higher power offers

protects the LED light source

greater dynamic range capability to OTDR

and the video camera when


used in harsh environments. The

Call: 732-516-6520.

Series C videoscope is suit-


able for routine and specialized

Call: 781-419-3562.

Laser diode modules

OSI Systems SCW 1430 laser

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


Send your product description and
photo to

September 2015 QP 67

The Certified Quality
Improvement Associate
Handbook: Basic Quality
Principles and Practices

most commonly used quality tools.

dedicated to customer-supplier relation-

the analysis and math, the author guides

Russell T. Westcott and Grace L. Duffy, ASQ

ships. There is also a nice discussion

the reader from basic systems up to large,

Quality Press, 2014, 288 pp., $69 member,

about the process of supply chains, which

complex and multistate systems and uses

$105 list (third edition, book).

includes key supply chain metrics. The

a consistent set of examples based on an

This book serves

last unit on system integration discusses

iterative approach.

as a valuable

the view of the organization as a system

source of informa-

and distinguishes the process view from

large hierarchal systems, and there is a

tion pertaining to

the systems view. It emphasizes taking a

chapter on process modeling. In discuss-

quality concepts,

systems view of quality improvement.

ing large, complex systems, the author

quality improve-

We live in an era of outsourcing and

offshoring. Recognizing this, there is a unit

This book is written in simple and

system breakdowns and variations of system arrangements and performance.

Easy to read but challenging in terms of

Other systems are discussed, such as

uses the asymptotic approach along with

ment and continu-

easy-to-understand language such that

ous improvement.

readers with little or no knowledge of

The information

quality concepts can understand and apply

of mathematics and research built around

is presented in

quality tools with confidence. This book will

a logical but comprehensive bibliogra-

five units, each dedicated to an important

serve as a valuable reference for everyone

phy. Elsevier specializes in technical and

aspect of quality improvement. The book

involved in the quality engineering and

leading-edge books, and this is representa-

begins with detailed explanations of the

quality management industry.

tive of that high standard. Please note that

key concepts and definitions pertaining to

Rangarajan Parthasarathy

quality, and then discusses the benefits of

Harvard, IL

quality improvement and employee involvement in quality improvement efforts.

There is a chapter dedicated to the phi-

several examples.
The book is a highly detailed assemblage

while this is a truly challenging topic it is

also logical, highly polished and thoroughly

Reliability of Large and

Complex Systems

losophies of the quality gurus. This chapter

Krzysztof Kolowrocki, Elsevier Insights,

contains valuable information regarding

2014, 460 pp., $200 (second edition, book).

Frank Pokrop
San Diego

the way the quality leaders viewed quality

The book assumes

and continuous improvement, and it also

readers are famil-

presents their contributions to the quality

iar with a number

How to Succeed With

Continuous Improvement:
A Primer for Becoming the
Best in the World


of underlying prin-

Joakim Ahlstrm, McGraw-Hill Education,

ciples of concepts

2014, 128 pp., $25 (book).

is the key to the success of any quality

Recognizing that employee involvement

such as reliability,

Big efforts often fail because no one feels

improvement project, the books second

calculus and how

responsible for major changes. Thats why

unit has two chapters dedicated to under-

to devise formulas

the most successful companies focus on

standing how employees work in teams,

that represent

improving the small things, which together

and the key issues involved in team forma-


add up to major paybacks. While this book

tion and group dynamics. The third unit is

mechanical and

is comprehensive and easy to read, it does

devoted to the tools and techniques used

electrical systems. It is clearly aimed at the

in continuous improvement and process

more experienced reader and dives into

improvement projects. There are elaborate

the world of complex systems, higher-level

ous improvement. The method of problem

explanations with suitable examples for the

math, and a continuous series of analysis,

solving and achieving improvement is not

68 QP

not focus on a specific industry or sector.

Simply solving a problem is continu-

important. This book discusses the FISHY

method for problem solving and provides

limitations and breaking points.

ples from the authors extensive work and

The book is broken into four sections

research to demonstrate application. The

many examples. The FISHY method entails:

building from an understanding of risk;

book also includes exercises and questions

1. Formulate the question.

to simple Monte Carlo simulations in MS

making it an excellent resource in an edu-

2. Individual work.

Excel; to applica-

cational environment. A glossary of terms,

3. Spread out the notes.

tions in fixed income

an index and reference material make this

4. Have consensus through voting.

and commodities; to

a good starting point for self-education.

5. Your to-do list is introduced.

a review of the prod-

The focus of this book is the corporate

The book includes success factors for

uct universe driving

risk-management professional. However,

improvement work and practical advice on

risk. The risk section

any person interested in using models to

how to start and

focuses on com-

better understand and manage riskpar-

maintain momen-

plexity of analysis

ticularly in the financial arenawill find this

tum. It features

versus complexity of

book interesting.

a questionnaire

models, dealing with

for determining

volatility, target accounts for managing risk

the current state

along with risk policy and risk regulation.

of a problem, a

The Monte Carlo simulation section de-

Bryan Ruggles
Everett, WA


reference guide

velops simplified MS Excel pricing models

for completing

and takes a layered approach to evaluate

fishbone diagrams

the effect of changes in prices on business

in 15 minutes and

and performance metrics. The fixed income

Configuration Management
For Senior Managers

and commodities section includes applica-

Frank B. Watts, Butterworth Heinemann,

tion examples that focus on identification

2015, 180 pp., $100 (book).

an additional reading list.

When you do not take time to make
improvement, you do not get better. Every

of relationships, drivers and data across

business will gain from following the

commodity markets. Finally, the last section

authors well-considered methods and

provides a broad review of the product

Quality Management in a Lean

Health Care Environment


universe, pricing and valuation models.

Daniel Collins and Melissa Mannon,

Marc A. Feldman

Models at Work: A
Practitioners Guide to
Risk Management
Jawwad Farid, Palgrave Macmillan, 2014,
656 pp., $75 (book).
If anything has been learned from history,
the importance of understanding how to
evaluate and model risk in the financial
markets is more important than ever. The
author takes a practitioners approach to

The book is well-written and follows a

logical progression. There are many exam-

Business Expert Press, 2015, 120 pp.,

$59.95 (book).

Advertisers Index



63 248-358-3003

CyberMetrics Corp.



EtQ Inc.



Minitab inc.


The National Graduate School



10, 11



risk management by developing simple

Quality Council of Indiana

models and testing them to understand the

The Quality Show

September 2015 QP



For information on placing an ad,

contact Media Sales at 866-277-5666.


were here to support you

Consulting Services for

FDA Regulated Industry

Established in 1994
Quality Assurance Professionals
Across the U.S. and Worldwide
Temporary or Permanent
Source Inspection

Over 25 years of experience and expertise in

FDA & ISO Quality Systems Compliance: QSR/QMS,
Design/Change Control, Verification/Validation, FMEA,
Risk Management, Audits, CAPA and FDA Remediation.


214-336-8650 *

3990 Old Town Ave. #C109
Fax 619-297-3251
San Diego, CA 92110 email:

Heres a great way to improve

quality or implement a
Quality Management System
and its FREE!


for Quality

We can create your data and submit within

72 hours
We do the work and invoice you
References found on our website
Based in the United States 734-205-8874

Place a
Recruitment Ad in
Quality Progress
and reach more than
100,000 readers from
all over the world!
Contact Media Sales
at 866-277-5666.


Be a part of the
research by visiting


Your Participation Is Needed

By participating in the Global State of Quality 2 Research survey,
you will help lead to a better understanding of quality strengths
and opportunities worldwide.



70 QP




The Global Voice of Quality




See the Full Spectrum

Monitoring the effectiveness of corrective actions

equacy are highly repetitive in nature (see

pearing, fault data spectrum (FDS) is a

Online Figure 1, found on this columns

The FDS grid (see Table 1) contains

tool that can monitor the effectiveness

webpage at

fault codes and product serial numbers

Faults are not created equal. The im-

of corrective actions (CA) on a continu-

and a positrol grid.

or production batch numbers. In each

ous basis. An FDS visually displays the

pact of a few could have catastrophic ef-

column, it color codes the implementa-

effectiveness of your CAs. If faults still

fects on the product, such as safety faults.

tion of CAs with reference to the affected

occur after CAs are implemented, your

Other types may occur in large numbers

product serial numbers. After the imple-

organization will catch them early enough

and not be noticed by customers and only

mentation of CAs, the faults should taper

to regroup the CA teams for additional

by highly critical inspectors. These faults

off drastically or disappear.

plan-do-check-act (PDCA) cycles, to

dont have any affect on functionality or

conduct proper root cause analyses and to

reliability and could be resolved through

was taken after product 226, but the ac-

create fully effective CAs.

simple changes to a process or material.

tion was only partially effective and didnt

This is why faults need classifications.

A fault can occur in a process or

For faults F1 and F2, for example, a CA

completely eliminate complaints. After

product component if its parameters

Acceptance quality levels (AQL) can be

another PDCA cycle occurred at product

deviate beyond the permissible limits of

decided for different categories of faults

326, the faults didnt recur in 2,700 prod-

its designed intent. A process fault could

based on the criticality of the product.

ucts sold.

happen due to high dispersion and can be

Critical healthcare equipment, for ex-

controlled by the process and machine

ample, will have a rigid AQL.

Faults are classified, coded and later

parameters. Process faults ultimately lead

to faulty products.
A fault also may result if the desired
output is not achieved with the intended

tureda costly lapse for the organization.

and the fault codes are created during

Faults three, four, five, seven and eight

development stages.

showed CAs that were done right the first

FDS of a subsystem with fault

codes and factual data for up to
3,000 units sold / TABLE 1

Fault data spectrum for XXXX assembly











xxxx not
with zzzz


xx/yy not

xx/yy not

Interim action
not fully effective

xxxx noise


a positrol sheet shown in Online Table 2.

short and effec-

For additional examples of FDS and posi-

tive. If it isnt, it

trol grids that were used on a manufactur-

will require anoth-

ing process for a hair dryer with five major

er cycle and cause

faults, see Online Tables 3 and 4.

FDS and fault classification are linked

cause of customer

and able to take actions upstream at tier


one, two and three supplier levels. They

is repeated inef-

can be used during development phases,

fective CAs (see

and each failure thats encountered in

Online Figure 2).

alpha, beta or pilot production is made

FDS is a tool
consisting of fault

visible for an easier and more effective

resolution. QP

with a positive

F1Fault 1 F2Fault 2 F3Fault 3 F4Fault 4 F5Fault 5 F6Fault 6 F7Fault 7 F8Fault 8

xxxx not
with yyyy

time, and the actions were described in

cycle should be

delays. A main


was equivalent to 100 products manufac-

traced in the field (see Online Table 1),

A PDCA cycle is used for CAs, and the

design input. Faults due to design inad-

The additional PDCA cycle did,

however, consume production time that


Containment action

White dot

control plan (also

called a positrol)
in a grid structure. The tool

UMESH KRISHNAPPA is a director at

Quality Manufacturing and Design
Solutions Technology Pvt. Ltd. in
Bangalore, India. He holds an MBA
from the Symbiosis Center for
Distance Learning in Pune, India.

uses an FDS grid

FDS = fault data spectrum

September 2015 QP 71



Just Do It
Quality organizations dont always need certifications

How do these organizations become

Service with a cookie

cations from the International Organiza-

so successful? They listen, respond,

Ive gone to the local eye institute for

tion for Standardization (ISO) do not

improve and start over again. They

several years. When I step inside, friendly

deliver high-quality products, and yet,

stay current with customers needs and

people are ready to help me at the front

organizations without these certifica-

expectations, study their competition

desk. The atmosphere is pleasant, and

tions sometimes provide amazing levels

and replicate best practices, and adapt to

there are color-coordinated walls, carpet-

of quality. Why is that?

changing conditions. In other words: they

ing and seating arrangements showing me

use the plan-do-check-act (PDCA) cycle.

where to find my doctor.

The goal of any organization is to

provide excellent quality products and

Whether the PDCA cycle is known to

The service is fast, and everyone has

services to its customers to earn their

an organization or not, its often intui-

a clearly defined job. Free coffee and

loyalty and repeat business. Its tradi-

tively implemented by smart, enterprising

tea are available at strategically located

tionally understood that organizations

people who know how to succeed without

stations, and theres even a staff member

possessing ISO certifications are the

all the charts, graphs and documented

who walks around with a tray of warm

best of the best. Sadly, this isnt always

management reviews. Instead of getting

cookies. Have a cookie please, she

the case, and sometimes even the op-

caught up on collecting paper (known as

says. Theyre delicious.

posite is true.

objective evidence to quality auditors),

Another staffer engages and consoles

they just do it. There are two real-world

some of the older patients. For patients

the importance of these certifications,

examples I frequently encounter that

who need assistance, a courtesy van

but you also should consider that some

illustrate organizations just doing it, not

waits outside to take them home.

organizations dont subscribe to these

overdoing it.

It would be a mistake to discount

standards, and their customers ratings

Great customer service is just one

piece of the quality puzzle, but many

show theyre superior to their certified

Consistent satisfaction

elements of the ISO 9001 standard are

counterparts. This is because they un-

When I visit Mikes Deli near my office,

represented in these examples, such as:

derstand what it takes to be successful

theres usually a line of customers in front

execution to management responsibility,

without all of the policies, procedures,

of the building before it opens. When the

customer focus, planning, provision of

work instructions and reams of docu-

doors open, people flock inside.

resources, infrastructure, consideration


One person takes your order and

gives you a number, and another
person works the cash register.

of work environment, product realization and data analysis.

Dont get caught up on quality certi-

You get a beverage at the drink

fications alone, and look deeper into an

station and sit down while your

organization as a whole. Everyone can

food is prepared. Within minutes,

learn from everybody whether they hold

your number is called, and youre

certificationsor not. QP

Regardless of how busy it is,
the service is consistently great,
the food is fresh and prepared
exactly how you requested, and
youre out the door in 20 minutes.
As you leave, the owner greets you
and thanks you for your business.

72 QP

RICK TOWNSLEY is a quality management systems advisor at Resource

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

ISO/FDIS 9000:2015 and

ISO/FDIS 9001:2015
The revised ISO 9001 standard will be published in fall 2015. But, dont wait to get a jumpstart on your training, auditing, and more to become certified to the new standard!
The ISO/FDIS 9000:2015 and ISO/FDIS 9001:2015 are now available for purchase!
To get started, and to learn more, visit

Remember to always stay connected to ASQ through the 3 Cs of standards.






The Global Voice of Quality



GAGEtrak Calibration Management Software


A streamlined, automated calibration process

that improves quality and maximizes productivity.

Monitor scheduled and unscheduled calibrations and alternate schedules

Track gage locations, issue/return and usage history
Produce calibration certificates and bar-coded labels
Conduct gage R&R analysis (MSA 4th Edition)
Create thorough, customized reports
Maintain FDA and ISO compliance and standards traceability
Seamless transition from paper records or other software
USA-based tech support

Download Your Free Trial at

The Worlds #1 Calibration Management Software Solution

Recommended by Auditors and Trusted by Quality Professionals for Over 25 Years


+1 (480) 922-7300