Family Legacyp. 46

The Ishikawa

Putting Best Practices to Work www.qualityprogress.com | September 2015

PQUALITY

KEEPCALM

AND

PREPARE FOR ISO 9001:2015

Let our experts help p. 18

The Global Voice of QualityTM

How to select an ISO 9001 consultant p. 8

Retool audits using the Kano model p. 38

Plus:

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FEATURES

• Small Business Challenge A sidebar for this month’s 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. • Audit Add-Ons More figures to illustrate how to evaluate your audit programs, the subject of “Amazing Audits,” pp. 38-45.

• Stay in the Loop Subscribe to the new Standards Connection enewsletter and stay on top of the latest ISO 9001:2015 developments.

• Back to Basics Translated into Spanish.

• Talk Back Rate and comment on this month’s four feature articles.

www.qualityprogress.comONLY @

STANDARDS Keep Calm and Prepare for ISO 9001:2015 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

SOFTWARE QUALITYA Hard Look at Software QualityA 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 Moisés Rodríguez, Mario Piattini and Carlos Manuel Fernández

AUDITING Amazing AuditsA new approach that incorporates the Kano model can help you evaluate the performance of your quality audit programs. by Lance B. Coleman Sr.

HISTORY Like Father, Like Son A look back at the lasting contributions Ichiro Ishikawa and Kaoru Ishikawa made to total quality management and the world of quality. by Gregory H. Watson

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ContentsPutting Best Practices to Work | September 2015 | www.qualityprogress.com

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LogOn• Advice on developing high-quality suppliers.

Expert Answers• Tips on initial ISO 9001 implementation.• Choosing the right ISO 9001 consultant or registrar.

Keeping Current • Dealing with drones.

Mr. Pareto Head

QP Toolbox

QP Reviews

DEPARTMENTS

Up FrontStress relief.

Measure for Measure Updates needed to the occupation classification list.

Quality in the First Person Learning early on to always do things right—not just when others are watching.

Career Corner In job searches, do your homework on prospective employers.

Statistics RoundtableIncluding nuisance factors during experimentation.

One Good IdeaUsing fault data spectrums to check corrective actions.

BONUSBack to BasicsAre standard certifications always necessary?

Mail Quality Progress/ASQ600 N. Plankinton Ave.Milwaukee, WI 53203Telephone Fax 800-248-1946 414-272-1734414-272-8575

Email Follow protocol of first initial and full last name followed by @asq.org (for example, vellifson@asq.org).

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

Author GuidelinesTo learn more about the manuscript review process, helpful hints before submitting a manuscript and QP’s 2016 editorial planner, click on “Author Guidelines” at www. qualityprogress.com under “Tools and Resources.“

Photocopying Authorization 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 Clear-ance Center, 222 Rosewood Drive, Danvers, MA 01923, 978-750-8400. Copying for other purposes requires the express permission of Quality Progress. For permission, write Quality Progress, PO Box 3005, Milwaukee, WI 53201-3005, call 414-272-8575 x7406, fax 414-272-1734 or email reprints@asq.org.

Photocopies, Reprints And MicroformArticle 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, 800-521-0600 x2888, international 734-761-4700, www.il.proquest.com.

Membership and Subscriptions For nearly 70 years, ASQ has been the worldwide provider of information and learn-ing opportunities related to quality. In addi-tion, ASQ membership offers information, networking, certification and educational opportunities to help quality profession-als 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 RentalsOrders for ASQ’s 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.

COLUMNS

QUALITY PROGRESS

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.

ASQ’s Vision: By making quality a global priority, an organizational imperative and a personal ethic, the American Society for Quality becomes the community for everyone who seeks quality technology, concepts or tools to improve themselves and their world.

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

- SUPPLIER DEVELOPMENT How one energy company uses an automotive standard to assess and manage its suppliers.

QP

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SPECIAL SECTION ASQ’S STANDARDS AND AUDITING GUIDE p. 62

58

UPFRONT

Stress ReliefHandy primer on the ISO 9001 revisionIT’S FINALLY HERE: the release of ISO 9001:2015. For months, many have been anx-

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

wait is over, now the clock starts ticking—organizations 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 organization’s 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 standard’s 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

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

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

This month’s 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 evalu-

ation form is provided to produce a ranking that is incorporated into the Kano model

and used to improve internal audit performance.

I was listening to a radio segment this week about Chicago’s Air and Water Show

and the newscasters were talking about what you couldn’t 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

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

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

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

Seiche Sanders

Editor

EXECUTIVE EDITOR ANDASSOCIATE PUBLISHERSeiche Sanders

ASSOCIATE EDITORMark Edmund

ASSISTANT EDITORAmanda Hankel

MANUSCRIPT COORDINATORValerie Ellifson

COPY EDITORSusan E. Daniels

CONTRIBUTING EDITORTyler Gaskill

ART DIRECTORMary Uttech

GRAPHIC DESIGNERSandy Wyss

PRODUCTION Cathy Milquet

ADVERTISING PRODUCTIONBarbara Mitrovic

DIGITAL PRODUCTION SPECIALISTSJulie StroikJulie Wagner

MEDIA SALESNaylor LLCLou BrandowKrys D’AntonioNorbert Musial

MEDIA SALES ADMINISTRATORKathy Thomas

MARKETING ADMINISTRATORMatt Meinholz

EDITORIAL OFFICESPhone: 414-272-8575Fax: 414-272-1734

ADVERTISING OFFICESPhone: 866-277-5666

ASQ ADMINISTRATIONCEO William J. Troy

Senior LeadershipAndrew BainesMichael BarryLynelle KorteBrian J. LeHouillier Lindsey LinderLaurel Nelson-Rowe

To promote discussion of issues in the field of quality and ensure coverage of all responsible points of view, Quality Progress publishes articles representing conflicting and minor-ity 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.

QUALITY PROGRESS

QP

September 2015 • QP 5

QP • www.qualityprogress.com6

LOGONHelping suppliers improveIn response to “Back to Basics: Sufficient

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

reer as a computer components software

quality engineer, I developed

and used an audit checklist

to identify risks. This created

a profile of the prospective

suppliers’ strengths and

weaknesses. We then worked

with the chosen supplier to

strengthen its weaknesses.

We also put in place incoming

inspections and testing as contingency

measures to protect our organization

from the supplier’s weaknesses.

The results from our inspections and

testing were communicated back to the

supplier to further drive its improvement

efforts. The supplier, in turn, communi-

cated its testing results to help identify

any test correlation issues.

As our inspection and test data im-

proved, we reduced, then dropped, our

incoming inspections. We only monitored

the final system test results and our

customer feedback to verify acceptable

quality and reliability. It was a lot of work,

but it resulted in developing low-cost,

high-quality suppliers.

Duane Briggs

Lexington, SC

Plenty still unknown“Open to Change” (July 2015, pp. 18-23)

provided good but incomplete information

on an unknown entity (ISO 9001:2015).

The author has provided a little more light

onto the shadowed outline of this critical

subject. I don’t think we will really know

what this new revision is until sometime

Seen&Heard

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

Executive Editor & Associate Publisher Seiche Sanders: @ASQ_Seiche

Associate Editor Mark Edmund: @ASQ_Mark

Assistant Editor Amanda Hankel: @ASQ_Amanda

Contributing Editor Tyler Gaskill: @ASQ_Tyler

editor@asq.org

www.facebook.com/

groups/43461176682

www.linkedin.com/groups/quality-progress-magazine-asq-1878386

next year when an auditor finds that one

clause everyone else overlooked.

Tom Fessenden

Cypress, TX

Clearing up misunderstandingsIn response to “Quality in the First

Person: Substandard Training”

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

description of a (continuing)

misapplication of the idea of

standardization of quality processes.

Even now, I am dismayed at the number of

offerings to help people “avoid mistakes in

interpretation” of the new version of the ISO

9001 standard. If the standard isn’t self-

evidently clear, it isn’t written well.

Certification will require agreement

with the auditor—so if you need any help

at all, you should ask the auditor. Indepen-

dent verifications are fine, but I still believe

the market is the best indicator of quality

success. If you satisfy the customers (with

whatever your system is), you will do better

than your competition.

Steven Cooke

Charlotte, NC

Jargon includedIn response to “Blank-Slate State” (May

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

exactly when creating a quality management

system. The only thing I do differently is

regarding “regulatory vomit.” I include this

jargon so the person being audited will not

be intimidated when the auditor uses it.

For example, “Show me your procedure for

product realization.”

Rick Paul

Escondido, CA

Tune In

The latest episode of ASQ TV dives

deep into root cause analysis, cov-

ering how quality tools helped save

a deteriorating national monument

and the benefits of using the scien-

tific method approach. Watch for

two new episodes this month: one

on standards and auditing (Sept. 8)

and another on ISO

9001:2015 certifica-

tion (Sept. 29). Visit

http://videos.asq.

org to access the

full video library.

The Global Voice of QualityTM

Plus:

P

Restaurants ramp up table-side

technology p. 10

Quality and social responsibility

cross paths p. 26

Organizational restructuring to optimize innovation p. 14

With DoEp. 20

Driving Creativity

Cultivating Creativity

Putting Best Practices to Work

QUALITY PROGRESS

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www.qualityprogress.com | August 2015

September 2015 • QP 7

QPQUALITY PROGRESS

PAST CHAIRStephen K. Hacker, Transformation Systems

International, LLC

CHAIRCecilia Kimberlin, Kimberlin LLC (retired – Abbott)

CHAIR-ELECTPatricia La Londe, CareFusion

TREASUREREric Hayler, BMW Manufacturing

SECRETARYWilliam J. Troy, ASQ

PARLIAMENTARIANSue Campbell, ASQ

DIRECTORSDonald Brecken, Ferris State UniversityHeather L. Crawford, Apollo EndosurgeryRaymond R. Crawford, Parsons BrinckerhoffHa C. Dao, Emerson Climate Technologies Inc.Benito Flores, Universidad de MonterreyJulia K. Gabaldón, Quality New MexicoEdwin G. Landauer, Clackamas Community CollegeDavid B. Levy, Boyce Technologies, Inc. Sylvester (Bud) M. Newton, Jr., AlcoaDaniella A. Picciotti, BechtelSteven J. Schuelka, SJS ConsultingKush K. Shah, General MotorsJames B. Shore, Quality Lean Solutions, LLCJason Spiegler, Camstar Systems Inc.Joal Teitelbaum, Escritório de EngenhariaG. Geoffrey Vining, Virginia Tech, Department of Statistics

QP EDITORIAL REVIEW BOARDRandy Brull, chair

Administrative Committee Brady Boggs, Randy Brull, Jane Campanizzi, Larry Haugh, Jim Jaquess, Gary MacLean,R. Dan Reid, Richard Stump

Technical ReviewersAndy Barnett, Matthew Barsalou, David Bonyuet, David Burger, Bernie Carpenter, L.N. Prabhu Chandrasekaran, Ken Cogan, Linda Cubalchini-Tra-vis, 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

QUICK POLL RESULTS Each month at www.qualityprogress.com, visitors can take an informal survey. Here are the numbers from last month‘s Quick Poll:

What is your organization’s biggest barrier to creativity?

Visit www.qualityprogress.com for the latest question:

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

QP

QualityNewsTODAYRecent headlines from ASQ’s global news service(All URLs case sensitive)

First 3-D-Printed Drug Approved by FDA3-D printing allows the pill to deliver a higher dosage of medicine—up to 1,000 milli-grams—while being porous enough to dissolve quickly. These attributes can particularly benefit patients who have difficulty swallowing their medication and miss doses of treat-ment. (http://tinyurl.com/3ddrug)

New Breed of Software Engineers Join Automotive IndustryTo cope with the software engineer shortage in the automotive industry, suppliers such as Visteon Corp. are turning to unconventional sources—such as the movie and video game industries—to recruit people. (http://tinyurl.com/autosofteng)

Videos feature ISO 9001:2015 expertsMost of the authors of this month’s cover story, “Keep Calm and Prepare for ISO 9001:2015” (pp. 18-28), appear on ASQ’s Standards Channel, where they discuss key changes in ISO 9001:2015 and offer advice for implementing it. Tune in to watch informational videos at videos.asq.org/asq-standards-channel. Don’t be a victimIn his Standards Connection enewsletter article, “Avoiding Misinterpretation Quicksand,” expert John Guzik clears up potential misunderstandings in the new version of ISO 9001. Read the article at http://tinyurl.com/iso9001quicksand and subscribe to the enewsletter at asq.org/standardsconnection.

www.qualityprogress.com

ONLINE EXTRAS@

WANT THE LATEST QUALITY-RELATED NEWS AND ANALYSIS? The QNT Weekly enewsletter, available exclusively to ASQ members, delivers it every Friday.

Subscribe now at http://email.asq.org/subscribe/qntwk.

A hierarchical structure that isn’t conducive to ideas rising up. Organizational silos prevent collaboration. Lack of an innovation strategy. Large team sizes hinder communication.

40.9%

13.6%36.3%

9%

QP • www.qualityprogress.com8

Business success with ISO 9001Q: If an organization wants to implement ISO

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

A: Use the organization’s purpose as a

starting point. Too often, organizations try

to appease or conquer requirements as

if the end-goal is to satisfy those require-

ments.

Not staying true to the organization’s

primary purpose (for example, to make

money through the product or service

offered or to effectively use the available

resources to promote educational excel-

lence) means the organization may create

a competition between the requirements,

such as those in ISO 9001, and its organiza-

tional purpose.

Using who you are as a business as the

reference point for implementing require-

ments will help the organization stay fo-

cused on what is important without getting

lost in the euphoria of becoming certified to

ISO 9001.

Q: How do you determine what is nec-

essary for a business to continue to be

successful in the future? How can ISO

9001:2015 be helpful in doing this?

A: Start by considering what it takes to

function as a business (organization) to

make money or receive funding today.

After you understand this, you can evaluate

the true cost of sustaining this.

While some costs are obvious, such as

facilities, materials and labor to produce

your product or service, don’t forget about

less-frequent expenses, such as main-

tenance costs, licenses or certifications

required to do business, and any other

costs related to sustaining the organiza-

tion. Often, organizations don’t account for

these costs because they are less likely to

get caught by a regulatory body. This isn’t

a sustainable business practice, however,

because when it comes time to pay for

one of these expenses, the money needed

hasn’t been accounted for in the budget or

pricing structure.

After you have accounted for everything

to run your business, think in terms of

planning to succeed. Risk-based thinking,

management review and data analysis are

great for this because they are intended

to help you assess actions already taken

to determine whether further action is

needed. In essence, the organization is

either already suitably established, ad-

equately addresses all requirements, and

is effectively driving behavior, or it has the

information and action plan to get there.

Q: How should an organization approach ISO

9001:2015 to make it work for its business?

A: Look at the standard through the eyes of

the business instead of trying to make the

business fit the standard. In other words,

many organizations usually take the stan-

dard and go through it clause by clause. To

see the standard from a business perspec-

tive, lay out the organization as it functions,

and plug in the standard’s clauses where

they apply to the organization.

This may mean a clause is accounted

for in more than one place in the docu-

mented system. That is actually a good

thing because you are dealing with the

organization’s reality instead of simply ap-

peasing the standard.

Robert Freeman

President, Practical Perspectives

McKinney, TX

Selecting consultants, registrarsQ: What are the qualities to look for when

selecting an ISO 9001 consultant and

registrar?

A: This question is timely because the

ISO 9001 and ISO 14001 revisions are

scheduled to be released in September

2015. Many organizations planning to

use external-expert help in implementing

their management systems and that are

planning to find a registrar to register their

management systems will find this answer

useful. This is an important question

because choosing the right consultant is

critical to accomplishing organizational ob-

jectives on time and on budget. Choosing

the right registrar is even more important

because you likely will stay with the same

registrar for several years to come.

Choosing a consultantISO 10019:2005 defines a quality manage-

ment system (QMS) consultant as a “per-

son who assists the organization on QMS

realization, giving advice or information.”1

This standard further recommends the

following attributes be considered when

selecting QMS consultants:

Ethics. Among the many personal at-

tributes recommended by the standard,

being ethical is a key attribute. An unethi-

cal consultant can cause more damage to

the organization than an incompetent

consultant. Organizations should check the

consultant’s past projects with clients to

ensure there isn’t any unfavorable feedback.

Other personal attributes to look for include:

observant, perceptive, versatile, tenacious,

decisive, self-reliant, communicative, practi-

cal, accountable and facilitative.

Experience. The consultant should be

EXPERTANSWE RS

September 2015 • QP 9

able to understand the organization’s

context and situation and provide creative

solutions. This comes from experience

in working with different-sized organiza-

tions, in various industry segments and

geographic locations, and on projects with

varying complexity such as providing low-

cost, high-value solutions for resource-

constrained small business clients.

Education and knowledge. The

consultant should not only have the right

level of education, he or she also should

have the necessary skills to understand

products and services. They should have

knowledge of all the relevant management

systems standards and other international

standards required to implement the sys-

tem well. Examples include sector-specific,

accreditation and product standards, as

well as safety-related standards.

The consultant should have expertise

or working-level experience in project

management and quality management

principles, methods and techniques.

Implementing the project may require the

use of quality engineering tools, statistical

techniques, problem solving, risk manage-

ment and change management.

Other aspects to consider are industry

knowledge and overall work experience,

including previous roles in quality and

operations management.

Choosing a registrarOrganizations do not frequently change

registrars, so selecting one requires a care-

ful review. Knowledgeable customers care

about who issued your QMS certification,

so it is important to consider the registrar’s

reputation. Reputation of an organization is

often an indirect measure of the quality of

its products and services over time.

If your organization has several locations

in a country or around the world, ensure

that the registrar has branches and a global

presence to support your needs. If your

organization plans to become certified to

additional management systems stan-

dards, such as ISO 14001, OHSAS 18001 or

industry standards, ensure that the registrar

carries these certifications and that the

auditors are qualified to audit to multiple

standards. This will allow you to conduct an

integrated management systems audit with

the help of a single registrar.

The registrar’s accreditation body also

matters. Find out if the accreditation body

is recognized in the regions where your

organization operates and your customer

prefers. Most importantly, your registrar

should have local auditors who have

solid industry knowledge and experience

in addition to proven audit experience.

If they must send auditors to you from

other regions and geographies to meet

auditor skill requirements, it will cost the

organization hefty travel and administra-

tive expenses year after year.

Ask customer references about the

quality of the registrar’s audit and the

value added to the organization.

Finally, consider overall audit cost. Ask

for the cost breakdown to understand the

typical estimated cost for an audit cycle

(typically three years). This should include

details such as the audit fee, annual file

maintenance, audit cancellation fee, annual

escalation fee and auditor travel expenses.

The registrar should be responsive to the

client’s needs and provide flexibility with

scheduling audits. It may be a good idea to

ask the shortlisted registrar to conduct a

pre-assessment to verify its capability be-

fore committing to a long-term relationship.

Govind Ramu

Director, quality assurance

SunPower Corp.

San Jose, CA

REFERENCE1. International Organization for Standardization, ISO

10019:2005—Guidelines for the selection of quality man-agement system consultants and use of their services.

EXPERTANSWE RSLook at the standard through the eyes of the business instead of trying to make the business fit the standard.

AT YOUR SERVICELet QP’s subject matter experts help you solve your toughest quality-related problems. Simply submit your question at www.qualityprogress.com, or send it to editor@asq.org, and we will find an answer for you.

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QP • www.qualityprogress.com12

TECHNOLOGY

Drone Dilemma? Opportunities abound, but safety concerns have some looking for more regulations

KEEPINGCURRE NTSince Amazon made a splash a few years

ago with plans to incorporate unmanned

aircraft systems (UAS) into its package

delivery service, all sorts of industries have

been abuzz about drones and brainstorm-

ing innovative ways to use this burgeoning

technology.

But is interest and usage in drones mov-

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

ministration (FAA) to keep up with concerns

over safety?

“The FAA has to act and toughen up the

rules before a tragedy occurs, be-

cause if a drone were sucked into

a jet engine of a plane filled with

passengers, untold tragedy could

result, and we do not, do not, do

not want that to happen,” said Sen.

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

maker who wants the FAA to speed

efforts to update regulations and

close loopholes covering the use of drones.1

High commercial interestAlready, the FAA has granted special permits

while it develops comprehensive rules to

govern how commercial drones should share

the sky with passenger planes. Proposed

rules for commercial drones were released

in February, and officials are now reviewing

thousands of public comments that were

submitted. The FAA has granted 944 com-

mercial drone permits as of July 28—with

thousands more applications pending.2

For instance, real estate businesses want

to use commercial drones to showcase

properties with videos taken from the air.

Farmers want to operate them to moni-

tor crops and tailor their use of pesticides,

herbicides, fertilizers and other applications.

Utilities are considering them to inspect

electric and gas lines in remote areas.

“To me, the diversity of industries that

are coming forward in this initial phase [of

applying for FAA special permits] and saying

we’d like to fly using [drones] is the most sig-

nificant element,” said Brian Wynne, CEO of

the Association for Unmanned Vehicle Sys-

tems International, a trade group. “We think

there’s a ready-made market out there.”3

After the FAA establishes the guidelines

for commercial use, the drone industry said

it expects more than 100,000 jobs to be

created and nearly half a billion dollars in

tax revenue to be generated collectively by

2025.4

It’s also predicted that drone activity

could be worth tens of billions of dollars

to U.S. companies over the next decade as

demand for this technology rises. Organi-

zations are expected to spend money on

drones to use for surveillance activities,

agriculture, weather and environmental

monitoring, oil and gas exploration, and

aerial imaging and mapping. Government

authorities, such as police, firefighters and

other first responders, also are expected to

invest in the technology.5

Addressing safety concernsAlong with the excitement and enthusiasm

over drones, concerns about aviation safety

surrounding this advancing technology

persist.

Consider just a couple of recent ex-

amples of disruptive drone activity:

• Pilots at New York’s John F. Kennedy In-

ternational Airport reported four

drone sightings within a three-

day stretch in late July and early

August. Other reports of near

collisions between drones and

airplanes have been reported in

Austin, TX, and Minneapolis in

recent months. FAA rules pro-

hibit drones from flying within

five miles of an airport and no higher

than 400 feet.6

• Unmanned devices were spotted flying

above flames and smoke from the for-

est fires in July in California, forcing fire

crews to ground water-dropping aircraft.

The delays allowed the fires to spread,

resulting in devastating property losses.7

FAA spokeswoman Elizabeth Isham Cory

said the agency receives about 60 reports

from pilots each month alerting the agency

of drones flying too close to airports, air-

planes or helicopters.8 Some state and federal-level lawmak-

ers, as well as private companies, are

looking to take action to protect the skies

September 2015 • QP 13

KEEPINGCURRE NTNAME: Himanshu Trivedi.

RESIDENCE: Ahmedabad, India.

EDUCATION: Doctorate from the Birla Institute of Technology and Science in Pilani, India.

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

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

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 envi-ronment at Bosch Rexroth further enhanced his understanding of quality not only as operational, but also as strategic and cultural.

ASQ ACTIVITIES: Trivedi has been an ASQ member since 2001 and helped establish ASQ’s 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 ASQ’s 2014 class of Fellows. Named one of “40 New Voices of Quality” by QP in 2011. ASQ-certified manager of quality/organizational excellence.

PERSONAL: Wife, Dhara; daughter, Isha; and son, Jignasu.

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

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

QWho’s Who in

(continues on p. 14)

and further regulate drones:

State: Proposed state legislation in California

would allow firefighters and law enforcement

personnel to take down drones hindering emer-

gency operations. The proposed law would give

firefighters and other first responders immunity

if they damage drones that are interfering dur-

ing 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,

drones. The act would create federal regulations

regarding when, where and how consumer

drones can be operated, while requiring new

safety technologies be built into all new drones.

This includes collision-avoidance technol-

ogy, transponders that signal a drone’s location

to air traffic controllers and other aircraft, and

geo-fencing—technology 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 con-

sumer drones after they are purchased.10

Private companies: Amazon, too, has pro-

posed a blueprint for a low-altitude air-traffic sys-

tem, said Gur Kimchi, a vice president who heads

the company’s drone-delivery division. Trafficking

the skies is essential before the world’s largest

online retailer can revolutionize how packages

are delivered using drones, he said.11

The only way drones can dart across the skies

without hitting each other or threatening tradi-

tional aircraft is by requiring the equivalence of

flight plans to be filed and ensuring that drones

QP • www.qualityprogress.com14

KEEPINGCURRENTMr. Pareto Head BY MIKE CROSSEN

Dealing with drones (continued from p. 13)

communicate their positions to a centralized

computer system available to all operators, ac-

cording to Kimchi.12

“It’s completely doable,” Kimchi said. “We can

only be safe and efficient if everybody else is

safe and efficient.”13

Privacy and quality of lifeAside from the concerns about collisions, some

drone doubters bring up privacy and quality of life

issues, envisioning swarms of drones interrupting

sunsets while delivering packages or swooping

across backyards to snap photos of unsuspecting

sunbathers.

Those concerns have the U.S. National

Telecommunication and Information Administra-

tion hosting discussions on developing voluntary

privacy standards for drones.

“From enhancing news gathering, improv-

ing agribusiness and equipping new delivery

models, to providing internet in remote areas,

the possibilities for UAS are staggering,” said

Angela Simpson, the agency’s deputy assistant

secretary for communications and information.

“Consumer trust and responsible operation are

keys to fully tapping the transformative potential

of unmanned aircraft.”14

—compiled by Mark Edmund,

associate editor

REFERENCES1. “Sullenberger: Drone Aircraft a Grave Threat to

Aviation Safety,” Aug. 3, 2015, CBS-DC, http://tinyurl.com/drone-safety-threat.

2. Bart Jansen, “Study Finds Showcasing Real Estate Most Popular Business Use for Drones,” USA Today, July 31, 2015, http://tinyurl.com/more-drone-uses.

3. Ibid.4. Christopher Doering, “Growing Use of Drones

Poised to Transform Agriculture,” USA Today, March 23, 2014, http://tinyurl.com/agricultural-drones.

5. Clay Dillow, “What is the Drone Industry Really Worth?” Fortune, March 12, 2013, http://fortune.com/2013/03/12/what-is-the-drone-industry-really-worth.

6. “Sullenberger: Drone Aircraft a Grave Threat to Aviation Safety,” see reference 1.

7. Matt Hamilton and Veronica Rocha, “$75,000 in Rewards Offered to Catch Operators Who Flew Drones Above Fires,” Los Angeles Times, July 28, 2015, http://tinyurl.com/drones-over-fires.

8. Nick Ferraro, “Drone, Airliner in Close Encounter Near Twin Cities Airport,” St. Paul Pioneer Press, Aug. 5, 2015, http://tinyurl.com/twin-cities-drones.

9. Matt O’Brien, “Drone Traffic Control? NASA, Ama-zon and Google Partner to Manage Self-Driving Swarms,” San Jose Mercury News, July 28, 2015, http://tinyurl.com/amazon-google-drones.

10. Clay Dillow, “Is Congress’ New Drone Safety Act an Innovation Killer?” Fortune, June 23, 2015, http://fortune.com/2015/06/23/congress-drone-safety.

11. Alan Levin, “Amazon Envisions Distinct Drone Zones for Future Delivery Fleet,” Bloomberg Business News, http://tinyurl.com/amazon-fleet-plans.

12. Ibid.13. Ibid.14. Grant Gross, “U.S. to Begin Talks on Drone Pri-

vacy Standards,” PC World, July 13, 2015, http://tinyurl.com/drone-privacy-standards.

ASQNEWS UPCOMING DIVISION EVENTS Three

September and October conferences are

being organized by ASQ divisions. ASQ’s

Inspection Division will host its annual

conference Sept. 10-11 in Dayton, OH.

Visit http://asq.org/inspect for more

details ASQ’s Biomedical Division is plan-

ning its “Design DoJo: Keeping Design

Controls Practical and Compliant” con-

ference Sept. 29-30 in Boulder, CO. Go

to http://asq.org/biomed for information

on the event. Finally, the second annual

Joint Technical Communities Confer-

ence—which involves 10 ASQ divisions—

will be held Oct. 22-23 in Orlando, FL.

Visit http://asqtcconference.com.

NEW CASE STUDY ASQ’s Knowledge

Center has released a new case study

about a team at a medical facility in

Dubai that uses the find-organize-clarify-

understand-select (FOCUS)/plan-do-

check-act (PDCA) model to determine

root causes of unreported medication

errors and identify potential improve-

ments. Read the case study at http://tiny.

cc/dubai-asq-case-study.

September 2015 • QP 15

KEEPINGCURRENTHEALTHCARE

BALDRIGE RECIPIENTS SCORE HIGH QUALITY MEASUREMENTSHealthcare organizations that received the

Baldrige National Quality Award matched or ex-

ceeded the measurements of healthcare quality

and patient experience of their nearby competi-

tors, according to a recent study.

Thirty-four organizations that received the

award were compared with 153 of their competi-

tors located within a 25 to 50-mile radius. Re-

searchers 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 Assess-

ment of Healthcare Provid-

ers and Services (HCAHPS)

surveys of patients.

“The HCAHPS patient

survey results were the

most significant findings

in this study,” wrote Ron

Schulingkamp and John

R. Latham, the research

authors.

“Hospitals that used the

(Baldrige Healthcare Criteria

for Performance Excellence, [abbreviated by the

authors as HCPE]) had higher means and lower

standard deviations (indicating a measurable

positive patient experience) than the non-HCPE

hospitals in all 10 measures,” the researchers

wrote.

The differences were statistically significant

for nine of those 10 measurements, the authors

wrote, showing there is a definite positive ef-

fect on patient experience with the use of the

criteria.

For more on the study, which was featured

in the recent Quality Management Journal

article “Healthcare Performance Excellence: A

Comparison of Baldrige Award Recipients and

Competitors,” visit http://tinyurl.com/baldrige-

healthcare.

ASQ JOURNAL SPOTLIGHTQP occasionally highlights an open-access article from one of ASQ’s

seven other journals.

This month, read “Finding Threats and Hazards Simultaneously in

the Concept Phase of System Development,” which appeared in the

June edition of the Software Quality Professional

(SQP).

Author Masao Ito focuses on finding hazards

and threats to assure system safety and security.

He uses the item sketch and goal model and ap-

plies 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 SQP’s webpage at http://asq.org/pub/sqp. From there,

you also can find a link to information about subscribing to the quarterly

publication.

V O L U M E S E V E N T E E N • I S S U E T H R E E • J U N E 2 0 1 5

Implementing Functional Safety StandardsRichard Messnarz, Christian Kreiner, Andreas Riel, Bernhard Sechser, Klaudia Dussa-Ziegert, Risto Nevalainen, and Serge Tichkiewitch

Taking a Fully Integrated Approach to Implementing Functional Safety According to ISO 26262 SuccessfullySerge Tichkiewitch, Andreas Riel, Richard Messnarz, and Christian Kreiner

A GSN Approach for Risk Management in Structured Assurance CasesXabier Larrucea and Izaskun Santamaria

The AQUA Automotive Sector Skills Alliance: Best Practice in an Integrated Engineering ApproachChristian Kreiner, Richard Messnarz, Andreas Riel, Serge Tichkiewitch, and Dick Theisens

Finding Threats and Hazards Simultaneously in the Concept Phase of System DevelopmentMasao Ito

Software QualityProfessional

www.asq.org

DATEINQUALITYHISTORYQP 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 indus-

trialist helped propel his family’s automobile company—Toyota Motor

Corp.—into a worldwide force and changed the way automobiles are

made.

Eiji’s 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 manufac-

turing methods. He returned and redesigned Toyota’s plants with ad-

vanced assembly techniques and machinery.

The unique Toyota management approach had three main objec-

tives: keeping inventory to a minimum through kanban or a “just in time”

system, ensuring each assembly step is performed correctly the first time,

and reducing the amount of human labor that went into assembling each

vehicle.

In 1967, Toyoda was named president of the automaker. Under his

watch, Toyota sold an all-time high 1.7 million vehicles in Japan and

1.7 million vehicles overseas in 1985, and profits peaked at $2.1 billion.

Toyoda stepped down as chairman of Toyota in 1994 at age 81.

SOURCE: www.notablebiographies.com/St-Tr/Toyoda-Eiji.html (case sensitive).

QP • www.qualityprogress.com16

KEEPINGCURRENTSHORTRUNSTHE DEADLINE TO submit nominations

for next year’s Harry S. Hertz Leadership

Award is Sept. 20. The award is named

for the long-time leader of the Baldrige

Performance Excellence Program. For more

details about the award, the nomination

process, award criteria and a list of the 11

selection committee members, visit www.

baldrigefoundation.org.

THE U.S. CELEBRATION of World Standards

Day, an event that recognizes the critical

role of various stakeholders across the stan-

dards community, including business lead-

ers, industry, academia and government,

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

For more information about the celebration,

visit http://tinyurl.com/world-standards-day.

TO MARK WORLD Statistics Day on Oct.

20, a data visualization competition is be-

ing held by StatisticsView.com and John Wi-

ley & Sons Ltd. For more information about

the competition, visit www.statisticsviews.

com/view/WorldStatsDayComp.html (case

sensitive).

THE ASSOCIATION FOR Manufacturing

Excellence (AME) announced the eight key-

note speakers who will be featured at its

annual AME Excellence Inside Conference

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

tion about the five-day event, visit www.

ame.org/cincinnati.

THE ANSI-ASQ National Accreditation

Board has become the first accreditation

program to offer the new international

featured standards (IFS) Food Store third-

party retail inspection standard in the

Americas. The IFS Food Store standard is

the only third-party inspection program

based on ISO/IEC 17020, which is currently

available from a leading global scheme

owner. For more information about the

accreditation, visit http://tinyurl.com/food-

store-inspection.

2016 Quality Progress Editorial Calendar

January Back to Basics: “Best Of” Edition

February Lean and Six Sigma

March The Multi-Generational Workforce

April The Cost of Quality

May Risk

June Change and Change Management

July The QP Career Guide

August Supply Chain and Stakeholders

September Benchmarking

October Standards and Auditing

November 40 Under 40

December Salary Survey

If you want to write for a specific issue, make sure to submit your article three to six months before the issue date. That allows time for the article to be reviewed, revised and prepped for publication. Don’t worry if you miss that deadline. Send the article anyway. All accepted articles will be published. Be sure to visit www.qualityprogress.com and click on “Author Guidelines” at the bottom of the page for more details.

QP’s 2016 editorial calendar has been released. Now, we’re looking for authors to write on these topics:

Looking for Your Type

QUALITY PROGRESS

P

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

Get Your ASQ Certification

For more information or to apply for an exam, visit asq.org/cert.

The Global Voice of QualityTMCERTIFICATION MEMBERSHIP PUBLICATIONSTRAINING CONFERENCES

KEEPCALM

AND

PREPARE FOR ISO 9001:2015Eight experts outline key changes

and how to handle them

September 2015 • QP 19

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 Com-

mittee 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 mul-

tiple languages and cultures. This is why a better—although not perfect—ISO

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 dur-

ing the transition process.

Certainly, not every change can be fully detailed in this article, and you’ll

find most of the changes relate to one another. Risk-based thinking, for ex-

ample, 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 9001:2015’s new features do provide

promise for improved quality.

—Allen Gluck

Editor’s 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.

QP • www.qualityprogress.com20

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 Certi-

fication 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 bachelor’s degree in natural science

from Harvard University in Cambridge, MA. Briggs is an ASQ-certified quality/organizational excellence man-

ager, 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 master’s degree in applied statistics from Villanova Univer-

sity in Pennsylvania. Cianfrani has implemented ISO 9001-compliant processes on six continents.

DEANN DESAI is a project manager for Georgia Tech’s Enterprise Innovation Institute in Atlanta. She has a

master’s 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 master’s 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 IAF’s ISO 9000 advisory group, and member of the Auditing Practices Group and the Ac-

creditation 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 master’s degree in administration from Gon-

zaga University in Spokane, WA.

DENISE ROBITAILLE is the author of 12 books, including ISO 9001:2008 for Small and Medium-Sized Business-

es (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.

THE PANEL OF EXPERTS

September 2015 • QP 21

ISO 9001:2015

Prepare for a New Structureby Deann Desai and Susan L.K. Briggs

What is the change?The structure of ISO 9001 has been revised. Clauses and

subclauses are retitled and reordered according to a

high-level structure that allows for all management sys-

tem standards (MSS) to be aligned.

To fully understand this change, some background

explaining why it was done should be helpful. From the

early 1990s, the International Organization for Standard-

ization (ISO) technical committee for quality manage-

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

vironmental management (ISO/TC 207) worked together

to enhance compatibility and avoid conflicting require-

ments between ISO 9001 and ISO 14001, the internation-

al environmental MSS.

In 2003, the ISO General Assembly received advice

from advisory and user groups that greater alignment of

the structure—including clause sequence and require-

ments in the standards—was desirable and achievable,

and that this would benefit organizations implementing

more than one MSS.

In 2005, the ISO Technical Management Board estab-

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

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

veloped. Building on this, the group developed the MSS

requirements, which were published as Annex SL in the

ISO/IEC Directives1, 2 in 2011.

Annex SL defines the high-level structure including

common text, terms and definitions along with guidance on

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

all ISO management system requirements standards will be

aligned, and ISO will seek to enhance the compatibility of

these standards through the promotion of identical:

• Clause titles.

• Sequence of clause titles.

• Text.

• Terms and definitions.

These items are permitted to diverge among stan-

dards only where necessitated by specific differences in

managing the individual fields of application.

What does it mean?The aim of Annex SL is to enhance the consistency and

alignment of existing and future ISO MSSs by providing

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

core text, and common terms and core definitions.

There are 10 elements in the Annex SL high-level

structure:

1. Scope.

2. Normative references.

3. Terms and definitions.

4. Context of the organization.

5. Leadership.

6. Planning.

7. Support.

8. Operation.

9. Performance evaluation.

10. Improvement.

These elements have driven the changes that users

will find in ISO 9001, including the restructuring of the

standard from eight clauses in the 2008 version to 10

clauses in the 2015 version.3

What do I need to do?A frequently asked question about this change is: “Must

organizations renumber their documents and other rel-

evant items based on the new structure of the standard?”

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

but many organizations will choose to do so as a tracking

mechanism—a way to keep things straight and ensure

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

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

bering will remain the same in future revisions.

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

ing introduction of context of the organization and risk,

came from the use of the high-level structure.

One of the key responses in the user survey conduct-

ed prior to writing the revision was that the connection

with the larger, strategic view of the organization was

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

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-

sues that can affect a management system—positively or

negatively. Part of an organization’s context also includes

relevant needs and expectations of interested parties that

QP • www.qualityprogress.com22

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

ested party requirements is used to guide the efforts to

plan, implement and operate a QMS.

The issues identified by an organization and the rel-

evant requirements of interested parties are linked to

the section on planning. The organization plans how

it will address any negative or positive consequence

posed by these issues and requirements in a prioritized

fashion in its QMS.

The purpose of planning is for an organization to

anticipate potential scenarios and consequences, and

as such, is preventive in addressing undesired effects

before they occur. Similarly, organizations should look

for favorable conditions or circumstances that can of-

fer 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,

prevents or reduces undesired effects, and achieves

continual improvement. Annex SL calls for actions to

address risks and opportunities in subclause 6.14 but

does not require risk management, risk assessment or

risk treatment.

The addition of these two strategic business pro-

cesses were included to encourage an organization’s

top management to become more actively engaged,

ensuring the QMS takes a more strategic view and is

integrated into its business processes, with the overall

intent to promote improved performance of the QMS.

REFERENCES AND NOTE1. International Organization for Standardization and International Electro-

technical Commission, ISO/IEC Directives, Part 1, Consolidated ISO Supple-ment, 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 Electro-technical Commission, ISO/IEC Directives, see reference 1, subclause 6.1.

Understand Your Contextby John E. “Jack” West and Charles A. Cianfrani

What is the change?The latest edition of ISO 9001 contains content that will

appear new to some users. The newness of the content

will vary widely among organizations depending on

their existing QMSs. An organization’s prior compli-

ance could have ranged from the absolute minimum

to deployment of processes that address the explicit

requirements and the intent of the latest requirements.

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

organization, therefore may require a widely different

range of attention by organizations transitioning to the

new version.1

Clause 4 introduces some new language and ex-

pands concepts related to defining requirements. A few

of the more notable changes include:

• Understanding the organization and its context.

• External and internal issues.

• Understanding the needs and expectations of rel-

evant interested parties.

Subclause 4.1 contains requirements for an organi-

zation to determine external and internal issues that

can affect and are relevant to its purpose and strategic

direction, and to monitor and review information re-

lated to these external and internal issues.

These requirements inject a QMS into an organiza-

tion’s strategic planning process. At a minimum, to “de-

termine external and internal issues that are relevant to

its purpose and its strategic direction,”2 an organization

must know its strategic direction.

This clause introduces the concept of requiring an

organization to think at strategic and tactical levels

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

ture strategic thinking nor detailed analysis and tacti-

cal thinking is sufficient by itself.

The standard mandates consideration of internal

and external issues that affect the ability of the organi-

zation to achieve its intended results. The requirements

also say the organization shall monitor and review the

issues it considers to be relevant to its purpose.

What does it mean?The requirements for understanding an organization

and its context mean an organization must know itself

and the external organizations and factors that do or

September 2015 • QP 23

ISO 9001:2015

can affect it. Achieving such an understanding can result

from activities such as performance of competitive anal-

ysis, assessment of existing and emerging technology,

and evaluation of its impact on the environment.

Such activities and assessments are elements of over-

all strategic and tactical planning for an organization and

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

ing, implementing, maintaining and improving a QMS.

This subject is a normal topic for top managers and is

interrelated with subclause 5.1.1 on leadership and com-

mitment,3 which requires top management to ensure a

quality policy and quality objectives are compatible with

an organization’s strategic direction and context. This is

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

What do I need to do?What is meant by “determine external and internal is-

sues”? What should be considered? How far should you

go?

One suggested approach is to have a formal process

for deciding what to consider and why. This approach

makes sense for several reasons:

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

2. It precludes going overboard on determining pertinent

external and internal issues.

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

empts disputes with external auditors regarding

compliance. The notes to subclause 4.1 provide guid-

ance.

An organization, for example, could develop a list of

areas in which issues could exist and perform periodic

evaluations of any existing or emerging problems that

might affect meeting requirements.

Examples of internal issues that could be considered

include:

• Internal audit results and self-assessment results.

• Analysis of quality cost data.

• Analysis of technology trend information.

• Competitive analysis.

• Results of customer reviews, audits, complaints and

feedback.

• Actual versus intended internal values and culture.

• Organizational performance.

• Best practices of the organization and comparisons

with industry benchmarks.

• Employee satisfaction data analysis.

One process that is underused but powerful in iden-

tifying internal issues is a self-assessment. It should be

considered for serious attention. Self-assessments can

be complex, using criteria such as those of the Malcolm

Baldrige National Quality Award, the European Founda-

tion for Quality Management or the ASQ guidelines for

performing a QMS self-assessment.

Assessment also can be simplified by using the seven

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

each organization to determine how detailed the analy-

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

review is needed.

External issues can be found through several tech-

niques such as analysis of:

• Economic environment and trends.

• International trade conditions.

• Competitive products and services.

• Opportunities and conditions related to outsourcing.

• Technology trends.

• Raw material availability and prices.

• Potential changes in statutes and regulations.

• Benchmarking best-in-class performers in and out-

side the current marketplace.

Also consider the potential interactions with other

processes of your QMS. For example, subclause 4.1 may

have direct or indirect interactions with your processes

dealing with interested parties, risks and opportunities,

or with clauses 8, 9 and 10.

These new requirements related to the organization

and its context should provide the organization an op-

portunity to expand the breadth and depth of its QMS,

integrate the QMS with the strategic and tactical manage-

ment of the organization, and align objectives throughout

the organization.

REFERENCES1. International Organization for Standardization, ISO/FDIS 9001:2015—Quality

management systems—Requirements, clause 4.2. International Organization for Standardization, ISO/FDIS 9001:2015—Quality

management systems—Requirements, subclause 4.1.3. International Organization for Standardization, ISO/FDIS 9001:2015—Quality

management systems—Requirements, subclause 5.1.1.4. International Organization for Standardization, ISO/FDIS 9000:2015—Quality

management.

SMALL BUSINESS CHALLENGEAre 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

Robitaille’s online sidebar “Resources: The Small Business Challenge,”

on this article’s webpage at www.qualityprogress.com.

QP • www.qualityprogress.com24

ISO 31000 GUIDES RISK-BASED THINKINGISO 9001 includes two new and related requirements: under-

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

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

risk nomenclature. How should you understand, implement and

audit to this requirement?

Fortunately, you don’t have to reinvent the wheel. These

concepts and their implementation are detailed in ISO 31000,1

the international risk management standard. Although ISO

31000 uses different terms, referring to that standard can help

organizations implement risk-based thinking in the context of

ISO 9001.

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

has always been implicit in ISO 9001”2 and chose not to require

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

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

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

extensive formal risk management process based on what is

appropriate for an organization.

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

some minimal risk management be integrated into an organiza-

tion’s quality system. Indeed, the writers deliberately created

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

ceptable degrees in which organizations may choose to manage

risk. Employing the term “risk management” may have implied

full adherence to the ISO 31000 standard is required, a sugges-

tion 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

popular internationally, and it will be helpful in implementing ISO

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

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

ful for understanding the organization and its context, which

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

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

professional training. Quality professionals who master ISO

31000 will be able to identify how detailed an organization’s

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

quirements of ISO 9001:2015.

Why should your organization embrace risk management as

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

“All organizations manage risk to some degree.”3 In layman’s

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

ing how the potential consequences of unknown factors can

help or hinder your organization’s objectives.

This idea is not new. The management of uncertainty is

something you do each day in your personal and professional

lives to ensure you achieve your objectives. The requirement

that consideration of uncertainty be part of formal and auditable

processes will serve to further quality and corporate objectives.

—Allen GluckREFERENCES1. International Organization for Standardization, ISO 31000:2009—Risk management—

Principles and guidelines.2. International Organization for Standardization, ISO/FDIS 9001:2015—Quality management

systems—Requirements. 3. Ibid.

Consider Risk by Denise Robitaille

What is the change?Many of the changes in ISO 9001:2015 will involve a

paradigm shift across all functions. The most prevalent

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

What does it mean?The idea of risk-based thinking isn’t particularly dif-

ficult. Whenever an organization decides to change

something or to respond to an impending change, there

are choices, consequences, opportunities and risks.

ISO 9001:2015 disperses language relating to risk

throughout the standard. The logical segue is that be-

cause the QMS touches most processes and depart-

ments, the need to engage in risk-based thinking is

similarly expanded to encompass multiple functions

throughout the organization.

What happens if you change the design of your most

popular product? You improve your position in the

marketplace and beat the competition. You also incur

September 2015 • QP 25

ISO 9001:2015

the need to carry inventory of replacement parts be-

cause you’ve made a commitment to your customers

to continue to support older versions of the product.

How about signing a contract that will double your

business? You’ll make a ton of money if you can: Get

suppliers to ship extra raw material, hire 15 more

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

tion schedule to keep your other customers happy.

What do I need to do?All organizations, but especially small companies,

must apply risk-based thinking in their internal envi-

ronments. A small amount of effort along these lines

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

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

When implementing risk-based thinking, parse

things out into manageable chunks. The benefit is that

you’ll have fewer unpleasant surprises resulting from a

failure to adequately assess the risk associated with a

change. The change can be as small as substituting an

epoxy or as overwhelming as moving the business to a

new facility.

One of the side benefits of the inclusion of risk-

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

ineffectual and cumbersome preventive action process

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-

ses and implementing sophisticated risk management

programs—all slick with data, pretty charts and graphs

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

ity for a small delivery service organization or a five-

person machine shop.

To help an organization of any size get over this

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

All of the language about the context of the organiza-

tion is directly relevant to the conversation about risk.

To understand your risks, you must understand your

organization—its internal and external issues, the in-

terested parties that can have an effect on it and its

ability to fulfill customer expectations.

These concepts also can be parsed into smaller

components. For smaller organizations, issues can be

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

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

side their entrance or change in the local schools’ cal-

endar affecting parents who need daycare. All of these

events carry risks that must be managed properly.

There are other changes that must be understood

and implemented. All the changes carry some benefit.

The transition process itself carries its own benefit

because implicit in the transition is the opportunity to

objectively assess a system and sweep away what isn’t

working.

REFERENCE1. International Organization for Standardization, ISO/FDIS 9001:2015—Quality

management systems—Requirements, clause 4.

Leaders, Step Up by Paul C. Palmes

What is the change?The 2015 revision of ISO 9001 contains several impor-

tant improvements regarding top management. Specifi-

cally, subclause 5.1.1 on leadership and commitment

for the QMS1 includes 11 requirements designed to en-

sure top management is involved and committed more

than ever before to the QMS.

Observers of ISO 9001 throughout the years have

consistently and correctly commented that QMS imple-

mentation results suffer without real top management

support. As a result, organizations are left to install

“bolt-on” quality systems limited to production relat-

ed issues—with primary top management interaction

through management review.

That’s about to change. According to subclause 5.1.1,

top management is required to “demonstrate leadership

and commitment” with respect to the QMS by:

1. Taking accountability of the effectiveness of a QMS.

2. Ensuring the quality policy and quality objectives

are established for a QMS and that they are compat-

ible with the strategic direction and the context of

an organization.

3. Ensuring the quality policy is communicated, under-

stood and applied in an organization.

QP • www.qualityprogress.com26

4. Ensuring the integration of the QMS requirements

into an organization’s business processes.

5. Promoting awareness of the process approach.

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

able.

7. Communicating the importance of effective quality

management and of conforming to QMS require-

ments.

8. Ensuring a QMS achieves its intended results.

9. Engaging, directing and supporting persons to con-

tribute to the effectiveness of a QMS.

10. Promoting continual improvement.

11. Supporting other relevant management roles to

demonstrate leadership as it applies to leaders’ re-

spective areas of responsibility.

What does it mean?From the perspective of an organization that is already

implementing ISO 9001 and looking to transition to the

new version of the standard, some will proudly affirm

the existing link between quality and business goals,

while others face a major realignment of their existing

systems.

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

suring that the quality policy is communicated, un-

derstood and applied within the organization,” are

management responsibility-related holdovers from

the 2008 revision. Several additional requirements in

the 2015 revision, however, affirm a fundamental shift

from having top management simply provide direction

and support to its becoming a key participant.

The QMS now must consider how to manage “ensur-

ing the integration of the QMS requirements into the

organization’s business processes.” They are now one

and the same, requiring quality objectives to support

the achievement of the organization’s business goals.

Who better to ensure business success than top

management? After all, top management also is tasked

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

ing and supporting persons to contribute to the effec-

tiveness of the QMS.”

What do I need to do?Given the importance of the material, explaining all

these changes to top management will best be accom-

plished through several meetings. It may be construc-

tive to use the second of Stephen R. Covey’s seven

habits by “beginning with the end in mind.”2

If you can clearly imagine the best outcome of each

meeting, you can work backward to imagine everything

you may need to achieve a successful set of results.

After all, for many organizations, effective implemen-

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

awareness of the process approach. No doubt, this may

become a teachable moment for many organizations,

requiring prepared materials to explain this fundamen-

tal concept to top management during these meetings.

Take your time. Be prepared and professional in

your approach. Develop appropriate action items and

venues for each requirement. Perhaps your organiza-

tion routinely schedules an all-organization business

status meeting conducted by top management. This

may be the perfect place to “communicate the impor-

tance of effective quality management and of conform-

ing to QMS requirements.”3

Others requirements in subclause 5.1.1 are also fair

game for such events, and if you use PowerPoint to

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

correct term is now “documented information,” but it’s

still acceptable to use terms to which you’ve become

accustomed).

Naturally, to just proclaim support is not enough,

and similarly no one expects top managers to move

into the quality department. The real work will be

somewhere in between when it becomes obvious to

everyone that top management actually is using the

quality system to guide and validate its decisions and

to encourage the discovery of new areas of improve-

ment throughout the organization.

Fundamentally, clause 5.1.1 in ISO 9001:2015 is a

call for top management involvement in the QMS. “In-

tegration of the QMS requirements into the organiza-

tion’s business processes” requires analysis and collab-

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

together to support common goals, the organization

develops deeper purpose, strength and success.

That’s the vision you must encourage—the goal you

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

REFERENCES1. International Organization for Standardization, ISO/FDIS 9001:2015—Quality

management systems—Requirements, subclause 5.1.1.2. Stephen R. Covey, The Seven Habits of Highly Effective People, Free Press,

1989.3. International Organization for Standardization, ISO/FDIS 9001:2015—Qual-

ity management systems—Requirements, see reference 1.

September 2015 • QP 27

ISO 9001:2015

Determine Your Documentation Needsby Bill Aston

What is the change?One of the more notable changes in ISO 9001:2015 will

be the nonexistance of any reference to requirements

for a quality manual, documented procedures and re-

cords to be maintained. Does this mean documented

procedures, records and other QMS documents are not

necessary?

No, that is not the case. Consider the requirements

of ISO/FDIS 9001:2015, subclause 4.4.2.1 This sub-

clause requires an organization to maintain document-

ed information (procedures) to support the operation

of its processes and to retain documented information

(records) to have confidence that processes were per-

formed as planned.

Annex A, section A.6, provides guidance regarding

the references made to requirements throughout the

standard to “maintain” documented information (such

as procedures, quality plans and a quality manual) as

well as to “retain” documented information (records).2

How are an organization’s requirements for QMS

documents determined? Every organization will be

responsible for determining the level of documented

information, such as procedures, needed to support its

QMS, processes, product and services.

ISO 9001:2015 will specifically require risk-based

thinking to be a part of every organization’s process

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

activity—it’s a regular part of an organization’s QMS

and product planning processes, which includes ensur-

ing controls, such as procedures or instructions, are

established to address identified risks.

ISO/FDIS 9001:2015 requires the following docu-

mented information to be maintained by every organi-

zation:

• Scope of the QMS (subclause 4.3).

• Information needed to support the operation of its

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-

lowing 18 records to be retained:

1. Monitoring and measurement of resources (sub-

clauses 7.1.5.1 and 7.1.5.2, a).

2. Personnel competency (subclause 7.2, d).

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

4. Review of requirements related to products and ser-

vices (subclause 8.2.3.2).

5. Design and development inputs (subclause 8.3.3).

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

7. Design and development output (subclause 8.3.5).

8. Design and development change (subclause 8.3.6).

9. Externally provided product and services (sub-

clause 8.4.1).

10. Traceability (subclause 8.5.2).

11. Property belonging to customers or external parties

(subclause 8.5.3).

12. Control of change (subclause 8.5.6).

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

14. Control of nonconforming process output, products

and services (subclause 8.7.2).

15. Monitoring, measurement, analysis and evaluation

(subclause 9.1.1).

16. Internal audit (subclause 9.2.2).

17. Management review (subclause 9.3.3).

18. Nonconformity and corrective action (subclause

10.2.2).

What does it mean?Concerning requirements for documented information

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

less prescriptive. This increased flexibility will sup-

port requirements for documented information to be

scaled to be appropriate to the complexity and criti-

cality of the products produced or services provided.

The greater the risk or potential consequences of the

nonconformance, the more control (procedures) re-

quired to address the probability of the risk and its

potential impact.

Documented information may include proce-

dures, work instructions, drawings, checklists, data

sheets, media or records as deemed appropriate for

QP • www.qualityprogress.com28

ISO 9001:2015

REVISION RESOURCESISO 9001:2015 is scheduled to be released later

this month and will be available for purchase at

asq.org. Find out more about the new standard by:

• Tuning in to the ASQ Standards Channel (videos.

asq.org/asq-standards-channel) to watch

experts discuss changes and transition advice.

• Subscribing to the Standards Connection

enewsletter at asq.org/standardsconnection to

have information delivered to your inbox every

month.

• Visiting Standards Central at asq.org/standards,

where you can find updates, articles and more.

an organization’s operation.

Risk-based thinking is essential for identifying risk

and the resources, such as personnel competencies,

equipment, facilities, product and services design, ma-

terials, process procedures and instructions required

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

formal risk assessments. The organization will deter-

mine whether a formal risk assessment is required and

if so, select a risk assessment method that best suits

its needs.

Future QMS audits will require auditors, consul-

tants and other interested parties to use a different ap-

proach to determining an organization’s conformance

with ISO 9001:2015 requirements. Auditors must be

knowledgeable about the risks associated with the

products, services and processes being audited, and be

able to assess the effectiveness of the controls used to

manage those risks.

What do I need to do?Consider the following actions to prepare for transi-

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 31000:2009—Risk man-

agement—Principles and guidelines to ensure fa-

miliarization with basic risk-management practices

and terms.3

4. Download free copies of risk-based thinking docu-

ments and PowerPoint slides via the ISO website.4

This information may be helpful for promoting and

understanding risk-based thinking.

5. Conduct a gap analysis of your existing QMS. Ask

your registrar to provide a checklist suitable for this

purpose.

6. Contact your registrar to determine its timeline

and requirements to transition clients with exist-

ing QMS certifications from ISO 9001:2008 to ISO

9001:2015.

7. If your organization is currently planning or in the

process of obtaining an ISO 9001 certification, con-

tact your registrar to determine their timing to begin

issuing ISO 9001:2015 as opposed to ISO 9001:2008

certifications.

ISO 9001:2015 will provide an organization in-

creased flexibility to maintain a QMS specific to its

particular processes and product. Risk-based thinking

will drive the organization’s need to ensure document-

ed information, such as procedures, instructions and

other QMS documents, are available to address risks

and opportunities. ISO 9001:2008 certifications will not

be valid after three years from the publication date of

ISO 9001:2015.

The International Accreditation Forum Informa-

tive Document 9: 2015 Transition Planning Guid-

ance for ISO 9001:20155 provides general guidance to

organizations, certification bodies and accreditation

bodies for preparing to transition from ISO 9001:2008

to ISO 9001:2015.

Future QMS auditing will need a different approach

to determining an organization’s conformance with

ISO 9001:2015 requirements. Techniques and skills

for auditors, consultants and other quality profession-

als must change to meet the new challenges of ISO

9001:2015. QP

REFERENCES1. International Organization for Standardization, ISO/FDIS 9001:2015—Quality

management systems—Requirements, subclause 4.4.2.2. International Organization for Standardization, ISO/FDIS 9001:2015—Quality

management systems—Requirements, Annex A, section A.6.3. International Organization for Standardization, ISO 31000:2009—Risk man-

agement—Principles and guidelines.4. International Organization for Standardization, Technical Committee 176,

Subcommittee 2 (ISO TC/176/SC2) homepage, http://tinyurl.com/TCSC2.5. International Accreditation Forum (IAF), IAF Informative Document 9: 2015

Transition Planning Guidance for ISO 9001:2015, Issue 1, Jan. 12, 2015.

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QP • www.qualityprogress.com1

In 50 Words Or Less • Software products are

more scrutinized today than ever because prob-lems can be costly.

• One pilot program used the ISO/IEC 25000 fam-ily of standards as a framework to evaluate software product quality.

• The structure let devel-opers address mainte-nance issues, as well as product quality and issues related to devel-opment processes.

Pilot program uses ISO/IEC 25000 family to evaluate, improve and certify software products

by Moisés Rodríguez, Mario Piattini and Carlos Manuel Fernández

at Software Quality

SOFTWARE QUALITY IS a key challenge for organiza-

tions 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 devel-

opment projects. In fact, only 39% of software projects finish on time with the

planned resources and with acceptable quality, according to the Standish Group’s

latest report “The CHAOS Manifesto.”1 See Figure 1 (p. 32).

To highlight the importance of software quality, a laboratory in Spain per-

formed a pilot program to evaluate, improve and certify the quality of software

products.

SOFTWARE QUALITY

September 2015 • QP 31

QP • www.qualityprogress.com32

Software evaluationActivities related to software quality have become in-

creasingly important, especially as more organizations

outsource their software functions. This means client

organizations must assess and monitor the quality of the

products they receive from software development orga-

nizations. In turn, these software development organiza-

tions must have the necessary resources to ensure the

products developed will meet client expectations.

Despite the proliferation of software quality process

certifications (for example, ISO/IEC 15504 Informa-

tion technology—Process assessment and certifications

from the Capability Maturity Model Integration Insti-

tute), there is little evidence conformance to process

standards actually guarantees good products. In fact,

critics suggest process standards guarantee only the uni-

formity of output and can possibly institutionalize the

production of mediocre or bad products.2

The idea that software evaluations should be based

on direct evidence about a product’s attributes rather

than circumstantial evidence about processes used to

build a product3 is becoming more widespread. An ever-

increasing number of organizations therefore are con-

cerned not only about the quality of the processes, but

also the quality of the products they develop and acquire.

This is because they may have serious quality problems

after the product has been implanted into their servers.

The new ISO/IEC 25000 family of standards, also

known as SQuaRE (Software Product Quality Require-

ments and Evaluation), appears to meet these needs.

ISO/IEC 25000 aims to create a common framework to

evaluate software product quality, replacing ISO/IEC

9126 and ISO/IEC 14598 and becoming the cornerstone

of this area of software engineering.

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

250404 defines the process of evaluating software prod-

uct quality, and ISO/IEC 250105 determines the software

product characteristics and subcharacteristics that can

be evaluated (see Figure 2).

The Spanish Associa-

tion for Standardization

and Certification (Aso-

ciación Española de Nor-

malización y Certificación,

or AENOR), which is a

member of the Internation-

al Certification Network

(IQNet), in collaboration

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

versity of Castilla-La Mancha, conducted the evaluation

and certification pilot project using the new ISO/IEC

25000 family of standards.

AQC and AENOR are independent organizations. AQC

is responsible for evaluating software product quality,

thus permitting organizations to meet a quality level and

improve their software products. AENOR, as an auditing

entity, is responsible for certifying the software product

in cases in which organizations, in addition to improving

their products, wish to become certified.

Initially, this pilot project mostly focused on the qual-

ity characteristic of maintainability because:

• Maintenance is one of the most expensive phases in

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

up to 60% of costs.

• Maintainability is one of the features most frequently

requested by software customers. It must be possible

for customers to evolve software products they ac-

quire—either by themselves or via a third party.

• Maintenance work on products with little maintain-

ability is more likely to introduce new bugs into soft-

ware products.

The evaluation and certification based on this family

of standards provides software development organiza-

tions and organizations that acquire such software a set

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

Five activitiesFor this project, it was first necessary to create the AQC

Lab using an agile approach,6 responsible for carrying

out the software product quality evaluation process. This

laboratory performs evaluations by conducting the five

activities proposed in ISO/IEC 25040:

1. Establish evaluation requirements: This activity’s

aim is to establish an agreement between the labora-

tory and client about which purpose and quality re-

quirements will be considered for the product evalu-

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

will be evaluated are identified, and the rigor of the

evaluation that will be performed is clearly defined.

The results are an initial version of the evaluation

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

ect’s scope was the complete software products.

Although some organizations had defined quality re-

quirements for their software products (such as low

complexity or good documentation), a decision was

made to expand them to the requirements associated

Project resolution results / FIGURE 1

43%

18%

39%

Results from 2012 CHAOS research

Successful

Failed

Challenged

September 2015 • QP 33

with the laboratory model.

2. Specify the evaluation: This activity’s objective is

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 thresh-

olds 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 refined version of the

evaluation plan with metrics and defined criteria.

In the pilot project, all the properties of the quality

laboratory model (covered later) were selected as the

thresholds established by the laboratory to certify the

product.

3. Design the evaluation: This activity’s purpose is to

plan the measurement and evaluation activities that

must be conducted, taking into account the prespeci-

fied scope and availability of laboratory resources.

The result of this activity is the final version of the

evaluation plan, with details of the dates of evaluation

activities and the specific resources involved.

In the pilot project, an initial assessment was

planned for each product. This assessment lasted

two weeks. Each organization requested a month to

correct its software products. Finally, the laboratory

planned a second evaluation of each product, which

took one week.

4. Execute the evaluation: This activity’s purpose is

to perform measurements on the software product

and apply the decision criteria specified in the second

activity. Thanks to the automated laboratory environ-

ment, this activity can be performed quickly and reli-

ably, and the evaluation results are stored in a secure

repository, which can be accessed via a web applica-

tion that allows visualization and analysis.

The result of this activity is a set of values obtained

for all metrics, indicators, subcharacteristics and

quality characteristics.

5. Conclude the evaluation: This activity’s purpose is

to analyze the results obtained in the previous activ-

ity to ensure no errors occurred during the evaluation

and to generate the final evaluation report. This re-

port is the main output of the evaluation process and

will be delivered to the customers to allow them to

review it and, if necessary, express disagreement.

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

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

tivity, the laboratory also performs the disposition of the

evaluation data—that is, all records that no longer need

to be maintained (for example, product source codes)

are removed. This also occurs for confidentiality reasons

because any data that the client does not wish to remain

in the laboratory after the completed evaluation are re-

turned or eliminated.

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

IEC 25000 standards defines models and processes to as-

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

tablish a correlation between the metrics and thresholds

needed to identify the specific level of quality a software

product has.

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

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

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

ity properties from the software product’s source code.

SOFTWARE QUALITY

Software product quality model from ISO/IEC 25010 / FIGURE 2

Product quality model

Functional suitability

Performance efficiency

Compatibility Usability Reliability Security Maintainability Portability

Functional completeness

Functional correctness

Functional appropriateness

Time behavior

Resource use

Capacity

Coexistence

Interoperability

Appropriateness recognizability

Learnability

Operability

User-error protection

User-interface aesthetics

Accessibility

Maturity

Availability

Fault tolerance

Recoverability

Confidentiality

Integrity

Nonrepudiation

Accountability

Authenticity

Modularity

Reusability

Analyzability

Modifiability

Testability

Adaptability

Installability

Replaceability

QP • www.qualityprogress.com34

Quality propertiesThe objective of identifying these quality properties was

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

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

controversial, based on previous studies and research,

and accepted by the scientific community. The main

properties are:

• Violation of encoding rules—This property is

based on encoding rules for each language (such as

Java code standard) and the percentage of violations.

A set of related rules are checked for each quality sub-

characteristic.

• Code documentation—This property refers to com-

ments in the code that are used to explain the code’s

functionality. Well-documented code helps develop-

ers understand what it does. Comments also may in-

fluence the ability to reuse software because if you

know the functionality of a module, you can reuse

that module in another system.

• Cyclomatic complexity—This property is related to

the difficulty involved in implementing, testing, under-

standing, maintaining or modifying a program. As this

definition shows, the complexity is related to the fol-

lowing subcharacteristics: analyzability, modifiability

and testability. In applications with high complexity,

maintenance tasks require more effort and, therefore,

are more costly.

• Structuring—This property refers to dividing the

system into smaller parts. The quality of the system

design is closely related to this property: The correct

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

systems, packages and classes) facilitates develop-

ment and maintenance.

• Method size—The size of a system directly affects

its maintainability because a larger system obviously

requires more maintenance. It is considered more ap-

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

er level by using, for example, methods that directly

evaluate the overall size of the system. This is because

a change does not usually affect the entire system, but

rather a set of elements.

• Duplicate code—This property refers to code frag-

ments repeated in different parts of the system. Du-

plicate code makes it difficult to modify a software

application because solving a bug or making an im-

provement to the code requires changes to all parts of

the system where the duplicate code appears.

• Coupling—This property indicates the degree of in-

terdependence among software units (modules, func-

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

the lower the coupling in a software application, the

better its design is considered because low coupling

improves maintainability (if there is no coupling,

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

creases the reusability of software units.

• Cycles—This property refers to the existence of cy-

cles of dependence among the system packages. The

acyclic dependencies principle states there must be no

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

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

maintainability because a change that is made to one

packet affects all the packets in the cycle.7

• Cohesion—This property indicates the degree of re-

lationship between the elements in a module. A class

has low cohesion when it performs several unrelated

functions. The functionality provided by its methods

thus has little in common with them. The analyzabil-

ity, modularity and, in general, maintainability are

negatively affected because these systems are more

difficult to understand. They provide features that are

unnecessary and changes in requirements that affect

several modules.

The evaluation process, the quality model and the

properties, along with a measurement environment,

allow a laboratory to evaluate a software product and

calculate its quality values. The measurement environ-

ment automates the evaluations by up to 90% and has

three different levels:

Benefits of evaluating software product quality / FIGURE 3

Software development companies

Organizations that acquire

software

• Control software product quality.

• Improve product characteristics.

• Ensure customers receive the appropriate level of quality.

• Compare among competitors’ products.

• Place the product on the market.

• Increase product sales.

• Know the quality of the product purchased.

• Compare between alternatives.

• Establish service-level agreements.

• Attain vendor independence.

• Minimize production failures.

• Reduce the final cost of acquiring software.

September 2015 • QP 35

1. Measuring tools—These constitute the

first level. Their mission is to analyze the

source code and generate files (usually

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 organization’s own or via a third party)

that analyze new programming languages or

compute new metrics for other quality char-

acteristics.

2. Evaluation system—This involves the in-

termediate level of the environment. Its ob-

jective 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, subcharac-

teristics and characteristics.

3. Visualization environment—This repre-

sents the top level of the environment. Its

objective is to present the information ob-

tained after the software product evaluation in an un-

derstandable manner.

Besides showing the values of quality properties,

subcharacteristics and characteristics, this environ-

ment also allows you to obtain a historical report for

multiple versions of a product, compare different prod-

ucts and even generate predefined reports.

Thanks to this framework, the laboratory has achieved

accreditation as a laboratory for quality software prod-

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

of standards from Entidad Nacional de Acreditación, a

member of the International Laboratory Accreditation

Cooperation under ISO/IEC 17025.

Six steps to certify productsAfter organizations have evaluated and improved their

software products, they can choose to certify these prod-

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

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

fication and has defined the communication flow, shown

in Figure 5 (p. 36).

• Step one—If interested organizations wish to certify

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

contact an accredited laboratory and request an evalu-

ation report. At this point, the five evaluation activities

will begin.

• Step two—As a result of product quality evaluation,

the organization will obtain a quality evaluation report

(shown in Figure 4). Based on the report’s results, the

organization may choose to become certified (if the

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

lished quality thresholds.

• Step three—When the organization has an evaluated

product with an adequate level of quality, it can request

certification from AENOR by providing its data and the

product to be certified.

• Steps four and five—AENOR will contact the ac-

credited laboratory (step four) to check whether the

organization really has evaluated its software product

and the level obtained is adequate for the certification.

In this case, the laboratory will provide AENOR with

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

continue the certification process.

• Step six—Finally, AENOR will carry out the certi-

fication audit using information from the evaluation

laboratory and information obtained after a visit to the

developer. As a result, AENOR creates an audit report

with the results and presents the certificate of product

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

Several assessments and refactoring cycles were

necessary during the pilot project. Three organizations

eventually attained quality certifications for their soft-

ware products: a document management system, a digi-

tal library for mobile platforms and supplier application

SOFTWARE QUALITY

Example of evaluation report results / FIGURE 4

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 in-

creased.

• The corrective maintenance effort was reduced 90%.

• Product quality evaluations were incorporated into

the software development life cycle.

This pilot project has gained widespread acceptance

by the participating organizations—those that suc-

ceeded in certifying their products and those that did

not—because they were able to detect the principal

maintenance problems so they wouldn’t repeat them in

the future.

This pilot project also has shown that the software de-

velopment 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 in-

ternational standards such as the ISO/IEC 25000 family.

Finally, after this first pilot project, the scope of labo-

ratory evaluations is now being broadened to include

new quality characteristics of ISO/IEC 25000, such as

functionality, usability and performance. Furthermore,

AENOR also will support the certification of the new

quality characteristics, and it will work to align the soft-

ware product certification with the software process

certification. QP

REFERENCES1. 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 engineering—Systems and software quality requirements and evalu-ation (SQuaRE)—Evaluation process, 2011.

5. ISO, ISO/IEC 25010, SQuaRE—System and software quality models, 2011.6. Javier Verdugo, Moisés Rodríguez 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.

MOISÉS RODRÍGUEZ is CEO of the Alarcos Quality Center (AQC) and director of AQC Lab in Ciudad Real, Spain. He has a master’s degree in computer science from the University of Castilla-La Mancha in Ciudad Real. Rodríguez is an Information Systems Audit and Control Association (ISACA)-certified information system auditor, Asociación Española de Normalización y Certificación (AENOR)-cer-tified ISO/IEC 15504 chief auditor and Test management approach (Tmap) Next Certified.

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

and information systems control (CRISC)—all from ISACA. He is a senior ASQ member.

CARLOS MANUEL FERNÁNDEZ 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. Fernández has a master’s degree in computer science from the Technical University of Madrid. He is a CISA and CISM from ISACA and has been certified by the Informa-tion Technology Infrastructure Library Foundations.

Flow followed during the pilot software product certification / FIGURE 5

Company interested in software product

qualityAENOR

Asociación Española de

1. Request for evaluation of product quality

2. Quality evaluation report

3. Request for certification

6. Audit results and certificate of product quality

4. Request for evaluation report

5. Evaluation results

AENOR = Asociación Española de Normalización y Certificación,

or Spanish Association for Standardization and Certification

AQC = Alarcos Quality Center

Example of software product certificate / FIGURE 6

SOFTWARE QUALITY

QP • www.qualityprogress.com36

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Access this month’s featured content and more Web exclusives in the ASQ Knowledge Center at asq.org/knowledge-center/featured.html.

CASE STUDYLack 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.

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The Global Voice of QualityTMCERTIFICATION MEMBERSHIP PUBLICATIONSTRAINING CONFERENCES

ASK THE EXPERTS ISO 9001 and TQM

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

Evaluating an audit program’s performance with a standardized approach and the Kano model

In 50 Words Or Less • A process and form al-

lows organizations to evaluate the performance of their audit programs.

• The evaluation’s score is applied to the Kano mod-el, determining whether the program satisfies the organization’s needs.

• The process allows or-ganizations to track their audit programs’ status over time and the effec-tiveness of implemented improvements.

by Lance B. Coleman Sr.

A QUALITY AUDIT program could

be considered a service for an organiza-

tion that’s provided by the quality depart-

ment. Because of this, the Kano model can

be the ideal lens for analyzing the perfor-

mance of an organization’s quality audit

program.

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 ben-

efits 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), per-

forming (more is better) and exciting or

delightful service (surprises and delights

the customer).1

Amazing Audits

September 2015 • QP X39

AUDITING

focuses on customer service and the ben-

efits 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), per-

forming (more is better) and exciting or

delightful service (surprises and delights

the customer).1

Amazing Audits

QP • www.qualityprogress.com40

The model (see Figure 1) stresses the pursuit of de-

lightful service delivery as a driver for continuous im-

provement and business success. It also can be used as

a powerful visual for displaying progress in customer

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

tion’s ultimate goal—delivering outstanding (delight-

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-

provement while the program itself continues to im-

prove. To know whether you have an excellent audit

program, an assessment must take place, but complet-

ing a quantifiable, accurate and objective assessment

of an internal quality audit program is easier said than

done.

I started by creating an evaluation form (see Figure

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

rated into the Kano model, which provides a needed

framework for evaluating the service of an internal au-

dit program.

Evaluation formsThe evaluation form assesses critical areas of an audit

program, and it weights audit planning as the largest

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

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

pects of an organization that must be monitored are

consistently reviewed, and the evaluation form awards

points for conducting the audits as scheduled. After all,

having the best plan in the world is worthless if that

plan isn’t properly implemented.

The ability to support corporate and site goals is

an often-overlooked segment of an internal audit pro-

gram. It also should be seamlessly integrated into a

risk management program and play an integral role.

The next area of the form addressed reporting and

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 ac-

count for another 30% of the base score.

The reporting strategy for audit results was ad-

dressed to ensure critical and major concerns were im-

mediately reported to the appropriate parties. Safety,

legal and functional issues are examples of findings

that might be reported to a wider group of managers.

The final 30% of the score relates to having adequate

resources, organizational structure, variability and

breadth of the audit program’s impact. Some questions

that determine whether an audit program has the nec-

essary resources are:

• Are there enough auditors to complete the number

of comprehensive audits required within the given

timeframe?

• Do auditors have the experience, skills and educa-

tion to evaluate the areas they’re auditing?

• Is the required infrastructure—such as office space,

computers and supplies—needed to manage the

program in place?

• Is there a budget for travel if off-site audits are re-

quired?

• Are there authority and management support to con-

duct audits?

After a base score has been attained, you will evalu-

ate 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.

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, sub-

tracts points from the base score. Finally, there are

point deductions for findings related to issues not pre-

viously noted by the internal audit program and repeat

Kano model / FIGURE 1

−Dissatisfaction

Satisfaction

+Delighters(excitement factors) Primary satisfiers

Servicefully functional

Must-be(basic requirements)

Servicenot functional

September 2015 • QP 41

findings from the previous year. An organization also

should include repeat findings that resulted from an

external audit.

These points are added or subtracted from the base

score (see Tables 1 and 2) using a five-point rating

scale:

• Five is very good or the best possible.

• Four is above average.

• Three is minimally acceptable.

• Two needs improvement.

• 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

minimally passing and 90% or greater (a minimum rat-

ing of three out of five in every category) is considered

excellent—or delightful on the Kano model.

This assessment model allows an organization to

define each rating according to its guidelines. Simi-

larly, the users decide what is adequate or more-than-

adequate training for auditors, including the level of

resources needed to carry out the mandates of their

programs. After an organization defines its ratings,

the model should be consistently applied to provide

results that can be analyzed and used as input to the

continuous improvement program.

The audit cycleAn audit program manager (APM) develops plans

based on organizational, site and audit program goals,

which include various aspects of compliance, improve-

ment and risk management. The APM may receive indi-

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

pends on an organization’s policy and the experience

of the lead auditor.

The APM drives the audit’s execution phase by pro-

viding policies, procedures, resources and credential-

ing requirements, and he or she will include this in the

auditors’ assignments. APMs receive reported audit

results from lead auditors, and they analyze those find-

ings and report them to site management.

Responses to the audit are included as input in de-

velopment of future plans. This entire cycle (see Online

Figure 1, which can be found on this article’s webpage

at www.qualityprogress.com) is repeated with momen-

tum from ongoing revisions of goals and objectives,

including analysis of data provided by the audit results.

After my audit program went through this rating

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

ing reflected my first impression of the program when

I arrived at the site. The improvements I made during

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

my anecdotal and subjective opinion of the program’s

status at that time.

The evaluation form’s elements were chosen be-

cause they’re as objective as possible and likely to be

consistent on a yearly basis.

Other factorsNote that there are other important measures of an

audit program’s success not included in this model.

This is because there are factors—beyond how robust

an audit program is—that might be involved in its im-

provement: for example, a yearly reduction in custom-

er audit findings.

Other possible reasons for improvement that are

unrelated to an audit program’s performance include:

different auditors, stricter clients, improvement in the

AUDITING

Value add

Points Description

+5 Observation that lead directly to $1,000+ lean savings.

+2 Observation that lead directly to $1-$1,000 lean savings.

+0.5 Opportunity for improvement that is implemented by area management.

Reality check

Points Description

−5 Each major finding against audit program from outside audit.

−3 Each major finding from outside audit that was previously identified internally.

−2 Each major finding against quality management system from outside audit.

−1 Each minor finding against audit program from outside audit.

−1 Each repeat finding from previous year.

Points added for value-add findings / TABLE 1

Points deducted based on results of external audits / TABLE 2

QP • www.qualityprogress.com42

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

dit only takes a sample after all).

Even other factors, whether they’re minor or major,

can contribute to a reduction of internal audit findings,

and it’s difficult to consistently quantify monetary sav-

ings from findings.

These key performance indicators should, however,

improve yearly as your audit program’s rating and the

program itself improve. Learn how to use this evalua-

tion 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. Ad-

just the ratings’ weights and add, change or remove

components to meet your organization’s needs, and use

it as an assessment of your assessment program. QP REFERENCE1. Kano Model Tutorial, ASQ.org, http://tinyurl.com/kanomodelasq.

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 engineer-ing 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 Auditor’s Review of Risk Management, Lean Improvement and Data Analysis (ASQ Quality Press, 2015). He is an instructor for ASQ’s quality auditor certification refresher course and is the newsletter editor for ASQ’s Lean Enterprise and Audit Divisions.

CASE IN POINTHere is an example of how to assess an audit program based

on existing records. Newly certified organization ABC was hav-

ing 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 second-

ary job function.

After reviewing ABC’s records, the consultant noted the fol-

lowing:

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 opportuni-

ties cited was followed up on.

4. The status of scheduled audits was not tracked.

5. Audit forms were completed inconsistently from person to

person.

6. Auditor meetings were not held.

7. Audit results were not regularly reported.

8. Training records were available only for four of six current

auditors.

9. Audit forms were poorly designed and did not logically flow.

10. Audit procedures were unclear and insufficiently detailed.

The consultant interviewed the existing auditors, and many

expressed dissatisfaction with their levels of training. All

confessed to occasional confusion about how to classify audit

findings, how to complete various audit working papers and

when to pursue formal corrective action. They said it was due to

unclear work instructions and poorly designed forms. Some were

concerned with having too many audits to do along with their

regular workloads.

Before beginning a root cause and corrective action pro-

cess analysis, the consultant rated ABC’s 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 ABC’s

records), ABC’s audit program was in the dissatisfaction quadrant

of the Kano model (see Online Figure 2, which can be found on

this article’s webpage at www.qualityprogress.com).

The next year, the following changes were implemented:

• Two new auditors were trained, and one worked on off shifts.

• Two of the existing auditors received refresher training.

• Portions of two audits were conducted during off shifts.

• The standard operating procedure for audits was completely

rewritten.

• Audit forms were revised, and auditors were trained to ad-

dress 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 wasn’t any nonconfor-

mance issued against the audit program itself. Figure 4 (p. 45)

shows the results of the following year’s audit program evaluation.

The improvements made to the audit program were substan-

tial, and as expected, they were reflected in the greatly improved

score. The new rating was more than three times greater than the

original score—well above minimally acceptable requirements

and within the margin of error for attaining the goal of 80%.

The score was in the must-be quadrant of the Kano model

(see Online Figure 2). There were still improvements that could

be made, and some areas’ low scores could easily be used as

a roadmap for improvement and delightful performance in the

future. —L.C.

AUDITING

Audit system evaluation form / FIGURE 2

Audit system evaluation

Date:

Planning (40%)

___ 5%—All audits are scheduled that should be scheduled (per requirements of the standard, regulation or internal policies).

___ 5%—All scheduled audits were conducted.

___ 5%—Percentage that were on time.

___ 5%— All nonscheduled audits (not on the annual schedule, but scheduled to address a concern that was identified) were conducted.

___ 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%)

Reporting—10%

___ Reported to site-level management.

___ Reported to quality manager.

Data analysis—10%

___ Reported data regularly analyzed and acted on.

Records—10%

___ Records maintained (audit reports).

___ Records maintained (training records).

___ Records maintained (quarterly or annual summary reports).

Implementation and results (30%)

___ 5%—Do we audit across all operating shifts?

___ 5%—Is there an appropriate level of auditor training (requirements + actual)?

___ 5%—Are an appropriate amount of audits dedicated to improvement activities?2

___ 5%—Is a documented and structured method for evaluating the validity and classification of findings?

___ 5%—Are there adequate resources?

___ 5%—Are varying types of audits used, such as process, product, trace, system or element?

Subtotal = potentially 100%

+ Value add percentage

– Reality check percentage

Total

Notes

1. ISO 9001:2008 and ISO 13485:2003 requires an audit program to monitor the effectiveness of a QMS, but it isn’t explained how you know whether the QMS is effective. It’s 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 ABC’s pre-improvement evaluation / FIGURE 3

Audit system evaluation

Date: mm/dd/yyyy

17% Planning (40%) 17 of possible 40 total rating x 40% = (17/40) x 0.4 = 0.17 = 17%

3 5%—All audits are scheduled that should be scheduled (per requirements of the standard, regulation or internal policies). Yes, but were points deducted because the schedule wasn’t 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) were conducted. 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. It’s 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%

Reporting—10%

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 analysis—10%

0 Reported data regularly analyzed and acted on.

Records—10%

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 percentage Five points were deducted for one major audit program finding, -12 for six major QMS findings, and -1 for one minor audit program finding.

23% Total

QP • www.qualityprogress.com44

Organization ABC’s post-improvement evaluation / FIGURE 4

Audit system evaluation

Date: mm/dd/yyyy

31% Planning (40%) 31 of possible 40 total rating x 40% = (31/40) x 0.4 = 0.31 = 31%

5 5%—All audits are scheduled that should be scheduled (per requirements of the standard, regulation or internal policies).

5 5%—All scheduled audits were conducted.

4 5%—Percentage that were on time. 80% of audits conducted on time; including overflow from previous year.

5 5%— All nonscheduled audits (not on the annual schedule and scheduled to address a concern that was identified) were conducted. 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 site management.

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%

Reporting—10%

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 analysis—10%

2 Reported data regularly analyzed and acted on. Improvement in this area was initiated.

Records—10%

5 Records maintained (audit reports). Hard and electronic copies of audit reports and schedule were maintained.

5 Records maintained (training records). All training records were current and available.

5 Records maintained (quarterly/annual summary reports).

16% Implementation and results (30%) 16 out of possible 30 total rating x 30% = (16/30) x 0.3 = 0.16 = 16%

2 5%—Do we audit across all operating shifts? Parts of two audits conducted on off shift.

4 5%—Is there an appropriate level of auditor training (requirements + actual)?

1 5%—Are an appropriate amount of audits dedicated to improvement activities? Improvement in this area was initiated.

3.5 5%—Is a documented and structured method for evaluating validity and classification of findings?

3.5 5%—Are there adequate resources? There were adequate resources to implement the program.

2 5%—Are varying types of audits used, such as process, product, trace, system or element? Only element audits were done.

73% Subtotal = potentially 100%

+ 6% Value add percentage Six points were added to the score for identified opportunities that were implemented.

– 0% Reality check percentage

79% Total

September 2015 • QP 45

AUDITING

Like Father, Like Son

THERE’S SOMETHING UNIQUE and

and special about the contributions the Ishikawa family

made to the global quality movement and its advance-

ment 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.

Looking back at the Ishikawa family’s contributions to

quality’s heritage In 50 Words Or Less • Ichiro Ishikawa and

Kaoru Ishikawa—the father-son quality duo from Japan—made last-ing contributions that changed the world of quality.

• Both influenced thought leaders and the quality community and helped establish a foundation for Japanese total qual-ity management, as well as quality thinking and methods worldwide.

September 2015 • QP 47

HISTORY

by Gregory H. Watson

. .

. .

This article provides the history of these contribu-

tions by the Ishikawa father and son duo and positions

their contributions as important components in estab-

lishing a foundation for Japanese total quality manage-

ment (TQM).

Exceptional fatherThe Ishikawa family’s roots are in Tokyo where Uichiro

Ishikawa (1862-1919), father of Ichiro Ishikawa, man-

aged the Kanto Sanso (Kanto Acid and Soda) company.

After Ichiro Ishikawa graduated from the Imperial

University of Tokyo and served there as an assistant pro-

fessor in applied chemistry for several years, he joined

his father’s company to begin a long management ca-

reer in the Japanese chemical industry, where he even-

tually became an industry leader during the war years

and served as president of Nissan Chemical Industries

and director of the Japanese Association for Chemical

Industries.

Following this period, he transitioned into a cross-

industry leadership role; first as chairman of the Japan

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

president of the Keidanren (Japanese Federation of Eco-

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

1948 to 1956.

When the Union of Japanese Scientists and Engineers

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

mittee was initially organized with Yoshitomo Tatumi

as the founding president. From the start, it was JUSE’s

intention to maintain a close relationship with industry

by inviting a recognized leader to serve as its chairman.

JUSE top management then invited Ichiro Ishikawa

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

with Kenichi Koyanagi, the first managing director of

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

the initial installation of Ichiro Ishikawa as the founding

JUSE chairman, JUSE has traditionally requested that

the chairman of the Keidanren or JFEO serve concur-

rently as its chairman based on this precedent.

During these pioneering years of JUSE, Ichiro Ishika-

wa played an important role in convincing senior manag-

ers of major Japanese companies to pursue quality as a

top-priority strategy for the reconstruction of Japanese

industry. In recognition of his lifetime contributions to

Japan and its industry, Ichiro Ishikawa was decorated

with the Grand Cordon of the Order of the Paulownia

Flowers of the Rising Sun by the emperor.

Ichiro Ishikawa’s role as JUSE chairman was not

merely an honorary position without real responsibility.

His focus was to convince Japanese business leaders of

their responsibility to pursue quality as a key business

objective for the recovery of Japan’s economy during the

postwar reconstruction years. In many ways, he acted as

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

in Japanese kabuki dramas to facilitate the actions on

the stage by the primary actors who are the visible focus

of the onlookers.

My belief in Ichiro Ishikawa’s role has been deduced

through a logical examination of evidence presented

through the Deming Prize records.

The effectiveness of Ichiro Ishikawa’s interventions

and a measure of his influence has been solidified by the

fact that he served as the first chairman of the Deming

Prize Committee (established in 1951) and at the first

Deming Prize Award Ceremony in September 1951. There,

the Deming Application Prize was awarded to four major

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

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

What Is Total

Quality Control?

The Japanese

Way, Prentice

Hall Inc.

Career milestones

BORN: JULY 13, 1915

Books published in English

KAORU ISHIKAWA

Doctorate, department

of applied chemistry,

faculty of engineering,

University of Tokyo.

QC Circle Koryo, General

Principle of the

QC Circle, QC Circle

Headquarters, Union

of Japanese

Scientists and

Engineers (JUSE).

Guide to Quality Control (fourth edition),

Asian Productivity Organization.

Assistant professor,

faculty of engineering,

University of Tokyo.

Professor, faculty

of engineering,

University of

Tokyo.

President, Japanese

Society for Quality

Control (two-year

term).

Professor

emeritus,

University of

Tokyo.

Professor,

Tokyo

University of

Science.

President, Musashi

Institute of Technology

(currently Tokyo City

University).

President,

International

Academy for

Quality (IAQ),

three-year

term.

QP • www.qualityprogress.com48

1939 1947 1960 1974 1976 1978 1981 1980 1982 1985 1989 1952 1971 1977 1982 1983 1986 1987 1988 1990 1993 1994 2007

September 2015 • QP 49

In the following year, eight additional organizations

received this award: Asahi Chemical Co., Furukawa

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

ogi & Co., Takeda Chemical Industries, Toyo Spinning

Co. and Kyushu Cloth Industry Co.

During the remainder of Ichiro Ishikawa’s tenure as

JUSE chairman, three to four organizations received

this award each year. Many of these recipients came

from the chemical industry, and were major Japanese

organizations that you would expect to be active in the

Keidanren, or were critical infrastructure industries that

were necessary for the reconstruction of a broad-based

manufacturing capability for rebuilding the Japanese

economy.

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

Deming Prize Award recipients. While no strong conclu-

sion can be drawn from this information, it appears that

there might have been an “invisible hand” operating be-

hind the scenes that caused company executives to pur-

sue quality in the same way as Adam Smith’s invisible

hand guides the benefits to the whole of society based on

the actions of an individual.1

Another component of Japan’s quality effort was the

engagement of top-level executives, which was combined

with a strategy adopted by JUSE of providing knowledge

and expertise—externally through the lectures by qual-

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

through developing internal experts on quality.

Evidence of this strategy to get Japanese thought

leaders involved in industry and academia is clear when

examining the list of individual awardees of the Deming

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

search Group, chaired by Shigeru Mizuno, were recog-

nized with this award: Tetsuichi Asaka, Kaoru Ishikawa,

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

ura and Eizo Watanabe. Encouraging these individuals,

and, in particular, Ichiro Ishikawa’s son Kaoru Ishikawa,

to dedicate their intellect and energy to developing qual-

ity in Japan was an exceptionally important strategy that

led to efficient management.

While my arm’s length observations of the actual activ-

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

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

ure of Ichiro Ishikawa to serve in a persuading way to

engage industry and individuals to support Japan’s fledg-

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

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

the future, a researcher will search the JUSE archives to

determine the validity of this personal belief.

Exceptional sonI have expressed my deep respect for the contribu-

tions of Kaoru Ishikawa in an earlier article2 in which

I explained how my initial introduction to quality came

through the study of his approach to reviewing projects

for quality improvement in a series of videos produced

by Hewlett-Packard in the early 1980s.

Although I never met him, Kaoru Ishikawa became a

HISTORY

Honors and awards

Introduction to

Quality Control

(third edition),

3A Corp.

1939 1947 1960 1974 1976 1978 1981 1980 1982 1985 1989 1952 1971 1977 1982 1983 1986 1987 1988 1990 1993 1994 2007 DIED: APRIL 16, 1989

Deming Prize

for Individuals,

Deming Prize

Committee.

Eugene L. Grant

Award, ASQ.

Blue Ribbon Medal

of Honor, Japanese

government.

Honorary Member,

Japanese Society

for Quality Control.

Walter A. Shewhart

Medal, ASQ.

Honorary

member,

ASQ.

Order of Sacred

Treasure, Gold

and Silver Star,

Japanese

government.

Academician

Emeritus,

IAQ.

Establishment of

the QC Circle Kaoru

Ishikawa Award, QC

Circle Headquarters,

JUSE.

Establishment

of the Kaoru

Ishikawa Medal,

ASQ.

Honorary member, IAQ.

Establishment

of the Founders

Medal, IAQ.

EDITOR’S NOTEFor more information about Kaoru Ishikawa’s life com-pared to the parallel development of quality control, see “Postscript: A Parallel Chronology of Dr. Ishikawa’s Life and Japan’s TQC” at www.juse.or.jp/english/archives/.

QP • www.qualityprogress.com50

virtual mentor to me because I realized how profoundly

he shaped how I formulated my own approach to quality

consulting. He has greatly advanced the development of

quality by managing its transition across generations and

across cultures.

Through the development of a collective system of

quality—total quality management (TQM) the Japa-

nese way—he demonstrated an appreciation for the

systemic effects of quality and its cultural adaptation

by focusing on the core components that are universal

elements and may be applied in any industrial concern

or cultural context.

Kaoru Ishikawa’s professional life was dedicated to

developing and guiding the fledgling Japanese quality

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

sons learned during its quality journey.

1915JAPAN CELEBRATES CENTENNIAL OF KAORU ISHIKAWA’S BIRTHDATEThis year, Kaoru Ishikawa would have turned 100, and Japan is

honoring his legacy.

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 il-

lustrious career.”

This project has two objectives:

1. Transfer Kaoru Ishikawa’s achievements and philosophy to

the next generations around the world.

2. Demonstrate how his philosophy, ideas, methods and activi-

ties can be effective today and will continue to be relevant

tomorrow.

Three major activities are planned this year:

1. The 1993 book Kaoru Ishikawa—The Man and Quality Control,

published by Keiko Ishikawa, Kaoru Ishikawa’s widow, has

been translated into English by a number of volunteers and is

now available for download at: www.juse.or.jp/english/

archives.

2. A new collection of papers about Kaoru Ishikawa will be pub-

lished electronically on the same JUSE website.

3. A commemorative symposium Sept. 28 at the University of

Tokyo to celebrate the centennial anniversary of his birth.

The chairman of the executive committee is Noriaki Kano,

Kaoru Ishikawa’s 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 Presi-

dent 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-

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

Edwards Deming Distinguished Service Award for Dissemination

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 Ishikawa’s accomplishments include:

• Founding the Japanese Society for Quality Control (JSQC) in

1970 with Shigeru Mizuno and Tetsuichi Asaka with Yasusa-

buro Hara as its first president.

• Establishing JUSE and JSQC programs for the Deming Prize,

three monthly academic journals on quality, and various

quality conferences and symposiums, which continue to be

conducted.

• Founding the International Academy for Quality with Armand

V. Feigenbaum (United States) and Walter A. Masing (Germa-

ny).

• 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

teams of Japanese executives and contributed to international

cooperation in quality control under the sponsorship of various

Japanese organizations.

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

States, Czechoslovakia, Finland, France, Sweden, Switzerland,

Brazil and the United Kingdom to conduct seminars and confer-

ences to transfer Japanese TQM to other countries. He wrote 31

books and more than 600 papers on various topics related to

quality. —G.H.W.

EDITOR’S NOTEFor more information about Kaoru Ishikawa’s teachings, see these ASQ open-access

articles:Kondo, Yoshio, “Kaoru Ishikawa: What He Thought and Achieved, a Basis for Further Re-

search,” Quality Management Journal, July 1994, pp. 86-91. http://asq.org/data/ subscriptions/qmj_open/1994/july/qmjv1i4kondo.pdf.

Watson, Gregory H., “The Legacy of Ishikawa,” Quality Progress, April 2004, pp. 54-57, http://asq.org/data/subscriptions/qp/2004/0404/qp0404watson.html.

September 2015 • QP 51

Furthermore, through his own writings and publica-

tions and through the research that he encouraged oth-

ers to pursue, Kaoru Ishikawa assured that learnings

from Japan would be transferred to the West because

the Japanese TQM research and study committees of the

1980s translated their final reports into English to share

with the rest of the world.

Collaborative leadershipIt also is clear that Kaoru Ishikawa was not solely re-

sponsible for all of these results. Early development of

quality in Japan was indeed a collaborative effort. The

founding generation of Japanese quality thought leaders

included three men who served as prime movers within

the early Japanese quality community: Shigeru Mizuno,

Tetsuichi Asaka and Kaoru Ishikawa.

Shigeru Mizuno led the initial Quality Research

Group, which interpreted the words of Deming and Ju-

ran to help structure a uniquely Japanese approach to

companywide quality control.

Tetsuichi Asaka served as a consultant and quality

coach who guided Japanese industry leaders and their

companies in a disciplined approach to quality.

Kaoru Ishikawa contributed to the development

of quality methods and shaped the formal structure of

Japanese quality infrastructure through his leadership in

JUSE and development of a national and global structure

for the encouragement and promotion of Quality Con-

trol (QC) Circle activities.

Kaoru Ishikawa became Japan’s representation when

speaking about quality through his international activi-

ties and by interpreting the Japanese total quality philos-

ophy, tools, methods, success stories and case studies.

His achievements in global quality consulting, backed

by the exceptional performance of Japanese companies

that were supported by his national quality colleagues,

created Japan’s strong reputation for quality perfor-

mance.

This collaborative approach to quality has served Ja-

pan well. Clearly, the pivotal role in the global dissemina-

tion of Japanese quality was the key personal contribu-

tion of Kaoru Ishikawa.

The ongoing legacy New science is built on the contributions of past scien-

tists. The same is true in the global quality movement.

What is the responsibility of one generation for the next?

This question is a focus that is inherent in the Shinto

faith. In this tradition, each person should leave the

world a better place as a way of honoring the wisdom

that has been gathered by ancestors, by passing on and

preserving this knowledge for future generations.

Each person will contribute to the continual cultiva-

tion and nurturing of this knowledge to create an ever-

more refined state of being. The responsibility of each

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

our experience as humans. Perhaps this implicit cultural

mindset of Japanese thinking is best described in a guid-

ing precept of Japanese business:

“Contribute to developing the welfare of the country

by working together, regardless of position, in faithfully

fulfilling your personal duty and show gratitude for the

contributions of others in things that are both great and

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

ing, the responsibility of each generation is to develop

the following generation so that it is capable of fulfill-

ing its own responsibility and extending the tradition of

learning and doing.”

This was accomplished by Kaoru Ishikawa because he

was a mentor for a second generation of Japanese qual-

ity thought leaders: Yoshio Kondo, Takanori Yoneyama

and Genichi Taguchi. The current generation of Japanese

quality thought leaders also have been his disciples, stu-

dents or colleagues. They include Hitoshi Kume, Noriaki

Kano, Shoji Shiba and Yoji Akao.

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 profes-

sionals remember your contributions and thank you with

deep gratitude for your gifts to our current knowledge

and capability, which would not have been achieved

without your diligent efforts. To paraphrase Isaac New-

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

have stood on the shoulders of giants.” QP

REFERENCES1. Adam Smith, The Wealth of Nations, 1776.2. Gregory H. Watson, “The Legacy of Ishikawa,” Quality Progress, April 2004,

pp. 54-57.

HISTORY

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.

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September 2015 • QP 53

MEASURE FOR MEASURE BY CHRISTOPHER L. GRACHANEN

Where Do You Fit?Updating the U.S. Standard Occupational Classification System

MANY READERS may not be familiar

with the U.S. Department of Labor’s Stan-

dard Occupational Classification (SOC)

System. According to its website, the SOC

is a:

… system used by federal statistical agencies

to classify workers into occupational catego-

ries for the purpose of collecting, calculating

or disseminating data. All workers are clas-

sified into one of 840 detailed occupations

according to their occupational definition. To

facilitate classification, detailed occupations

are combined to form 461 broad occupa-

tions, 97 minor groups, and 23 major groups.

Detailed occupations in the SOC with similar

job duties, and in some cases skills, educa-

tion, and training, are grouped together.1

Discovering disparityThe SOC is updated about every 10 years

(the last update was in 2010), with the

next update slated for 2018. I first became

aware of the SOC in 2002 when I was look-

ing for demographic information regarding

the population of calibration and metrolo-

gy practitioners in the United States to es-

timate the number of potential candidates

who may elect to become certified if an

ASQ calibration and metrology certifica-

tion program existed. The numbers were

needed to justify a proposal for creating

the program. The proposal was eventually

accepted by ASQ’s Board of Directors and

culminated in the creation of the certified

calibration technician program in 2003.

After examining the SOC, I learned it

does not recognize job titles and de-

scriptions for calibration technicians,

calibration engineers or metrologists,

which means information about these

occupations is not being collected via

U.S. censuses. This disparity prompted a

partnering of ASQ’s Measurement Qual-

ity Division, the National Conference of

Standards Laboratories International and

the Measurement Science Conference to

create a submission for calibration and

metrology job titles and descriptions to be

added to the 2010 SOC.

Unfortunately, SOC administrators ulti-

mately rejected this submittal on the basis

of insufficient substantiation of:

1. Unique tasks performed

2. Sufficient population numbers warrant-

ing recognition in the SOC.

Because the SOC does not contain job

titles and descriptions for calibration and

metrology practitioners, there are

essentially no standardized

definitions for these oc-

cupations. Standard-

ized occupational

definitions are used

to homogenize titles

and descriptions

across civil and

governmental con-

tracts, pay grades

scales and position

qualifications.

It is also important

to note that to assist

young adults in making

well-informed career

decisions, educators

frequently reference the

U.S. Department of Labor

publications to provide

information about oc-

cupations and forecasts

on future job growth. The

SOC listing is frequently

used to determine which occupations are

included in the majority of those publica-

tions. One of the major publications used

by educators for this purpose is the Oc-

cupational Outlook Handbook (OOH). The

following is from the OOH Teachers Guide

webpage:

The Occupational Outlook Handbook (OOH)

is an online career guidance resource that

provides information on hundreds of occupa-

tions in the United States. Updated every

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.

QP • www.qualityprogress.com54

• Work environment.

• Education, training and other qualifica-

tions needed to enter the occupation.

• Pay.

• Projected employment change and job

prospects from 2012 to 2022.

• Similar occupations.

• Contacts for more information.

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

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-

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 consid-

eration lessons learned from the 2010

submittal. It is anticipated that later this

year, the U.S. federal register will publish

the SOC’s decision on adding calibration

and metrology occupations for the 2018

SOC.

Bigger quality pictureSome readers may be asking what the

SOC position on inclusion of calibration

and metrology job descriptions has to

do with mainstream quality occupations.

To answer that question, all you need to

do is search the SOC website for “quality

engineer,” shown in Figure 1. The search

yields a single result, shown in Figure 2.

A query of the SOC website for “quality

technician” yields two results, shown in

Figure 3.

Furthermore, the alphabetical list of

SOC occupations does not list job titles

or descriptions for “quality engineer,”

“engineer, quality,” “quality technician,”

and “technician, quality.” You can deduce

the implications of this situation on the

quality profession, and arguably, this

warrants a call for action by ASQ leaders

to rectify this disparity. QP

REFERENCES1. “Standards Occupational Classification System,” Bureau

of Labor Statistics, U.S. Department of Labor, www.bls.gov/soc/home.htm.

2. Bureau of Labor Statistics, U.S. Department of Labor, “Teachers Guide,” Occupational Outlook Handbook, www.bls.gov/ooh/about/teachers-guide.htm.

CHRISTOPHER L. GRACHANEN is a distinguished technologist and operations manager at Hewlett-Packard 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.

MORE ON MEASUREMENTRead more Measure for Measure columns by Christopher L. Grachanen and other metrology experts by visiting the “Departments & Columns” tab at www.qualityprogress.com.

Standard Occupational Classification System search / FIGURE 1

Results for ‘quality engineer’ / FIGURE 2

Results for ‘quality technician’ / FIGURE 3

MEASURE FOR MEASURE

Quality Engineer

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The Global Voice of QualityTMCERTIFICATION MEMBERSHIP PUBLICATIONSTRAINING CONFERENCES

QP • www.qualityprogress.com56

QUALITY IN THE FIRST PERSON BY DEREK PURDY

Who Cares?A brother’s lesson resonates in doing jobs right the first time

A SOLID WORK ethic is especially impor-

tant for anyone in the quality profession.

Because the word “quality” is in your job

title, people hold your quality of work to a

higher standard. This is true for big things,

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

Do you follow up on tasks and track

them to completion? Do you proofread

emails before hitting send? Do you take the

time to really understand the documents

you sign? Do you show up and choose to

be present in the meetings you attend? All

of these things send a message about you

as a quality professional, and they either

bolster or tarnish your image.

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

facturing facility. In its heyday, it was

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

dilapidated. Upper management was unin-

terested in investing in it, and that attitude

was reflected in the crew’s demeanor.

One day, a maintenance worker was

assigned to repair equipment on the roof.

He’d been up there many times to fix the

same piece of equipment, and you have to

wonder why it wasn’t fixed properly the

first time. On this occasion, he was in a

hurry and didn’t bother to use fall protec-

tion.

He ended up accidently stepping on a

fiberglass skylight and falling 30 feet be-

fore an upward-facing handle of a butterfly

valve impaled his lower leg. If that valve

had been mounted just a few inches lower,

he’d have died instead of just being injured.

Another time, a worker was dispatched

to the manufacturing floor to weld a leak-

ing catch pan. When I went to verify the

job was complete, I saw a quality of work

that wouldn’t have survived the scrutiny of

my eighth-grade shop teacher. Besides the

hideous, wandering weld bead, there were

visible holes in the seam, and the pan was

still leaking. The workers who’d asked for

the repair rightly complained that they still

had a mess to deal with. Nonetheless, the

welder had signed off on the work ticket.

Where does this attitude come from?

I understood how demotivating upper

management’s view could be, but these

examples of laziness affected the safety

of the workers themselves and their co-

workers. What happened to doing a job

right because it’s the right thing to do?

What about taking pride in your work?

I realized some people never learned

the importance of a work ethic. I learned

that lesson early in life—helping my

brother fix his run-down, old car.

Setting the exampleWhen I was in grade school, my brother

Craig’s first car was a clunker he borrowed

from my grandfather. It was 1954 Pontiac

that had been rusting in a barn. The deal

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

but he had to return it in working condition.

It didn’t take long to see he’d gotten a

lousy deal. The transmission was on its

last leg, the brakes were going and the car

had countless other problems.

One evening, I went outside and saw

it in the driveway with an extension cord

snaking from the garage to the car. The

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

shifts (one that’s mounted to the steering

column), and there was an issue with the

linkage. Because the car’s 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 con-

necting to the horn, turn signal and other

areas. The wires didn’t 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

we’d just snip the wires and move on.

Who’d care that the horn and turn signals

didn’t work? Instead, my brother methodi-

cally labeled each wire on either side of

the cut. Eventually, we gained access to

the trouble spot; it took only minutes to

September 2015 • QP 57

fix the actual gearshift problem.

Daylight faded to full darkness, and the

temperature dropped. Our T-shirts were

filthy and we were shivering. I held the

light as my brother put lengths of heat-

shrink tubing on the wires, and painstak-

ingly twisted a wire back together and

soldered it. He slid the heat-shrink tubing

over the joint and shrunk it with a haird-

ryer. He then slid the cloth insulation over

the tubing and held it with electrical tape.

Anyone who’s tried holding a soldering

gun to a free-floating wire with one hand

while feeding solder with the other can un-

derstand how this felt like a never-ending

chore.

I noticed the cuts in the wires were

staggered to prevent the bulge created by

the repairs from piling up in one spot. As

a result, the wire bundle fit back down the

steering column and avoided chafing dur-

ing 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, “Why’d

you go through all that? Grandpa doesn’t

care about this car. He’s just gonna put it

back in the barn. And you’re only driving it

until you get something else anyway.”

“Doing the right thing when someone’s

watching is no big deal,” Craig said. “It’s

what you do when nobody’s looking that

counts. This isn’t my car. Grandpa just let

me borrow it. And I agreed to take care of

it. That means returning it at least in the

same condition as I got it. Take pride in your

work; if you’re going to do a job, do it right.”

I’m certain I’ve heard that advice many

times before and since—if it’s worth do-

ing, it’s worth doing well. But having such

a naked display of integrity at an early

age helped drive the message home with

greater force than anything I experienced

afterward.

This early lesson has served me well in

my personal and professional life. People

tell me they appreciate knowing that if I

say I’ll do something, I’ll do it—and do it

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

ibility it builds. It’s something that should

be intrinsic—not just for quality profes-

sionals, but for everyone.

These same principles apply on the

home front. Now that I have my own kids,

I feel it’s especially important to set a posi-

tive example so I can pass the lesson on to

a new generation. QP

DEREK PURDY is a senior quality engineer at SI-Bone in San Jose, CA. He holds a master’s degree in engineer-ing management from Old Dominion University in Norfolk, VA. An ASQ senior member, Purdy has served as member-ship chair and vice chair of ASQ’s Silicon Valley Section. He is an ASQ-certified

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QP • www.qualityprogress.com58

CAREER CORNER BY ROSEMARIE CHRISTOPHER AND PAUL DIONNE

Truth DetectiveTips for investigating prospective employers, avoiding duds

WHEN YOU’RE SEARCHING for a job,

you don’t want to end up working for

an organization that’s a dud. The U.S.

unemployment situation has improved,

and the tables are turning back in favor

of employees. Even people who’ve ex-

perienced long-term unemployment are

re-engaging in their job hunts.

Employers must consider their reputa-

tions as part of employee recruitment

and retention. Here are four potential

problems you should investigate at any

organization that’s offering you a second-

round interview:

• High turnover—This can be the result

of multiple issues. A strong HR leader

might be able to fix a turnover problem

but only with sustained support of the

CEO.

• Poor ethics—The ethics of an

organization’s leadership will trickle

down. If you see poor ethical decisions

being made, they’re likely happening

throughout the organization. Lower-

level employees practicing unethical

behaviors would be fired if their leaders

truly valued integrity. CEO intervention

will be required to improve ethical deci-

sion making, and don’t delude yourself

by believing you would be immune.

• Cheap—There’s not much value in tak-

ing a job if you’re not going to receive

the resources you need to accomplish

anything meaningful. Research the orga-

nization’s finances and look for signs of

poor pay or a lack of funds. A CFO or

CEO might be able to reverse the situa-

tion, but few others can.

• Bad culture—Symptoms of a bad cul-

ture appear in many forms. It’s possible

that people are too busy creating fief-

doms that inhibit change, or everyone’s

input is required, creating meeting after

meeting and preventing anything from

being accomplished. Poor ethics and fi-

nances may contribute to a bad culture,

too. It can cause employees to blame

others for their problems rather than

rolling up their sleeves and collaborat-

ing to reverse the bad situation. Unless

you’re the CEO, you’re not going to fix a

bad culture.

Uncovering the issuesUse LinkedIn to see

how long people stay

there. When recruiters

look at résumés and

see a string of short

employment stints, they

assume the person is

a job hopper. LinkedIn

gives us the power to

turn the tables and

understand an organiza-

tion’s turnover rate.

Use LinkedIn’s

advanced search feature and select the

“past company” category to find people

who previously worked at the organiza-

tion. View each profile to get a sense of

how long they stayed there. For large

employers, use the location, title or other

criteria to narrow your search to a par-

ticular department. Good signs include

long stays, promotions and people who

left but came back. It’s a bad sign when

you see a high number of people who

worked there less than a year.

Interview past employees. You can

send messages to previous employees via

LinkedIn’s InMail feature, and ask about

their experience at the organization.

There’s a pretty low chance of getting a

response. Few people want to badmouth

a previous employer, and you can assume

a lack of response means the organiza-

tion is below average. On the other hand,

if you hear back from someone, you may

receive make-or-break information you

couldn’t get elsewhere.

Check out the organization on Google

Finance or Yahoo Finance. If you don’t

know how to read corporate financials,

ask someone who does—having an

outsider’s perspective can help. Every

organization experiences financial highs

and lows. If it doesn’t look good, work to

understand why they’re in that situation

and what it would take to change it.

Read employee review sites such

as Glassdoor and Indeed. Again, most

people will avoid badmouthing a previ-

ous employer. When someone does, you

should take note, but read the reviews

carefully. They may have been faked or

embellished. Some HR departments have

been known to post favorable reviews

of their organizations. Although they

September 2015 • QP 59

work there, too, it’s a bit disingenuous.

Conflicting reviews also may reflect that

some employees had good bosses and

others didn’t.

Read customer review sites such as

Yelp, Google and the Better Business Bu-

reau (BBB). On these sites, customers air

their complaints and report issues with

an organization’s products or services.

Picture yourself working at that organiza-

tion, and distinguish between complaints

you would be in a position to address

versus ones that would be out of your

control. When the BBB receives com-

plaints, it contacts the chief executives at

each organization. On the BBB site, if you

see a slew of issues that weren’t resolved

to the customer’s satisfaction, there’s a

problem at the top of the organization.

Search industry regulators’ web-

sites. Every industry has its own set of

regulators—such as the Federal Avia-

tion Administration, National Oceanic

and Atmospheric Administration, or

U.S. Securities and Exchange Commis-

sion. Our organization provides staffing

for U.S. Food and Drug Administration

(FDA)-regulated businesses. We check

prospective partners for warning letters

and recalls on the FDA’s website (or

U.S. Department of Agriculture for food

recalls).

Some organizations will view a recall

or warning letter as a call for improve-

ment, which is good. Others will see it as

“government overreach” that they must

comply with, which is bad. We do not

recommend directly raising an issue in

an interview. Instead, ask questions that

will uncover whether the organization is

handling its current situation, and how

it’s going about it.

If you’re a CEO, CFO or board mem-

ber, investigate your organization. As the

game of talent acquisition heats up, you

don’t want to be left on the sidelines. QP

REFERENCE1. “Employment Situation Summary,” Bureau of Labor Statis- tics economic news release, http://tinyurl.com/t68g.

ROSEMARIE CHRISTOPHER is an organizational communications consultant and the president and CEO of MEIRxRS, a family of science, technology, engineering and math recruitment and staffing organiza-tions in Glendale, CA. She has a master’s degree in communication

management from the University of Southern California in Los Angeles. Christopher is an ASQ member and past chair of the ASQ Food, Drug and Cosmetic Division.

PAUL DIONNE is a business developer for MEIRxRS in Glendale, CA. He holds an MBA from Boston University in Massachusetts.

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QP • www.qualityprogress.com60

STATISTICS ROUNDTABLE BY CONNIE M. BORROR

Blocking BenefitsIncluding nuisance factors during experimentation

WHEN CONDUCTING even a seemingly

simple experiment—such as one with

a single factor with several levels—sig-

nificant care and consideration should

go into the design setup. It is rare for

the response of interest to be influenced

only by one factor under study during the

actual experimentation.

There could be a number of other

factors affecting the response if not

controlled or included in the experi-

ment. Those factors that are not the main

factors of interest but could influence

the response are often referred to as nui-

sance factors. If the nuisance factor can

be controlled during experimentation, it

is often included in the design setup as a

blocking factor.

If there is only one nuisance factor

with several levels, you try to carry out a

randomized block design—given the main

factor (factor of interest) can be random-

ized within each level of the blocking

factor. If there is more than one nuisance

factor, you may be able to include them in

the design setup as well as using designs,

such as the Latin square design. In this

article, the importance of blocking using

one main factor (with four levels) and

one nuisance factor (with three levels)

will be illustrated.

Corn flakes and ovensSuppose you’re interested in the thick-

ness of corn flakes after they have been

toasted.1 Toasting is just one of the

processing steps of corn flakes for cere-

als and can cause several changes in the

corn flakes, which in turn could affect the

consumer’s view of the cereal.

“Puffiness” or thickness is one

response of interest and is measured in

millimeters. Thirty flakes were toasted,

measured at five locations, and the aver-

age of all 150 thicknesses was used as the

response. The factor of interest is toast-

ing time, and four times are considered

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

Three replicates for each toasting

time were obtained while randomizing

the times. You want to know whether

toasting time has a significant effect on

flake thickness. In other words, is there a

statistically significant difference among

the toasting times?

In this experiment, there were three

ovens that could be used for toasting,

so toasting time could be randomized

within each oven. Because ovens may

operate differently and possibly affect the

flake thickness, ovens were treated as a

blocking factor in the experiment. There

were other possible nuisance factors at

play, but they were held constant for the

purpose of the experiment.

If you don’t include the blocking factor

in a designed experiment when it should

be included, you could obtain erroneous

conclusions about the factor of interest. In

addition, if the blocking factor was used

in the experiment, but the wrong analy-

sis carried out, you also could reach the

wrong conclusion about the factor of inter-

est. Let’s look at the latter a little closer.

ANOVA activitiesGiven the designed experiment discussed

earlier—with four toasting times and

three ovens—a total of 12 average thick-

nesses were obtained, as shown in Table

1. An analysis of variance (ANOVA) was

carried out for the experiment, and the

results are listed in Table 2. In this experi-

ment:

• The factor of interest is toasting time.

The goal is to determine whether there

is a statistically significant difference

among the four times. A final goal may

be to determine the optimal or best

toasting time.

• The oven is a blocking factor because

you think different ovens may influ-

ence the results, but it is not a main

factor of interest. That is, you’re inter-

ested in picking the optimal oven. You

will not determine which oven gives

the best results and only use that oven

and discard the other two.

The p-value for toasting time is 0.031,

which provides evidence there is a

statistically significant difference among

the four toasting times. Toasting time

appears to have a significant effect on

the average corn flake thickness. Some

statistical software packages will report a

p-value for the blocking factor as well. As

stated earlier, however, you’re not always

interested in statistical significance of the

September 2015 • QP 61

Blocking BenefitsIncluding nuisance factors during experimentation

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-

cluded in the experiment in the first place.

The correct analysisNow, carefully consider the importance

of blocking and using the correct analy-

sis. Suppose the experiment is run in the

exact same manner (with ovens as blocks

and toasting time randomized within the

block), but the results are incorrectly

analyzed without the blocking factor:

ovens. Table 3 provides the ANOVA for

this situation.

Now, notice that toasting time is not

statistically significant with a p-value

of 0.134. That is, toasting time does not

significantly affect flake thickness. What

happened? The degrees of freedom (df),

sums of squares (SS) and mean square

(MS) for toasting time are identical to the

previous analysis, but the F value and, of

course, p-value differ. These values are not

influenced by the addition or omission of

other factors (such as ovens).

The error has changed, however, and

it is the mean square for error that is used

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

toasting time. The error quantities now

include all of the values once represented

by ovens. The df and SS for ovens don’t

just disappear, but get lumped in with the

remaining “error.”

I like to think of the error as a trash

can: It’s where all quantities go that can-

not be assigned to some other factor or

interactions involved in the experiment.

I’d prefer the error not be large, but that

it could be parsed into df and SS for other

factors. That is, when you can identify a

source of variation, the df and SS can be

partitioned into that source (or sources if

more than one), and you have a better idea

of what role factors play in an experiment.

Because in this case, the error mean

square increased, the overall F value for

toasting time decreased (and resulting

p-value increased)—giving the wrong

result that toasting time is not statistically

significant. This is the wrong conclusion

because you know the origin of some

of the error quantities: the ovens, which

for some reason did not get included in

the analysis (I have seen this happen in

practice on more than one occasion). The

experiment involved ovens, which was the

appropriate design, but the wrong analysis

carried out.

Any time you can include a blocking

factor or other factors in the experiment

itself, you should. The next step is to

make sure to carry out the experiment as

planned, and if any deviation is encoun-

tered, it should be recorded and reported.

The type of analysis depends on the actual

experiment conducted. QP

REFERENCE1. 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 Uni-versity 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.

Oven

Time 1 2 3

20 1.6 0.6 0.7

40 1.7 1.6 0.8

60 2 1.2 1.6

80 1 0.7 0.3

Average corn flake thickness / TABLE 1

Source of variation DF SS MS F P-value

Toasting time 3 1.550 0.5167 6.02 0.031

Oven 2 1.145 0.5725

Error 6 0.515 0.0858

Total 11 3.210

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

Analysis of variance for corn flake thickness / TABLE 2

Source of variation DF SS MS F P-value

Toasting time 3 1.550 0.5167 2.49 0.134

Error 8 1.660 0.2075

Total 11 3.210

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

Analysis of variance for corn flake thickness without ovens / TABLE 3

Special Advertising Section

Standards and Auditing Guide

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

• Accreditation• Auditors• Certification

• Education• Tools• Training

And there’s much more to see! Take a look!

If you’re interested in appearing in next year’s guide, email mediasales@asq.org.

62 QP • www.qualityprogress.com

A2LA – American Association for Laboratory Accreditation5202 President’s Court, Suite 220Frederick, MD 21703 Phone: 301-644-3248 www.a2la.org

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.

A2LA’s areas of expertise include:• Continuing Education• E-learning• Metrology• On-site

• Quality Audits• Quality Training• Standards Training

AIAG (Automotive Industry Action Group)26200 Lahser Road, Suite 200Southfield, MI 48033 Phone: 248-358-3003 www.aiag.org

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.

AIAG’s areas of expertise include:• Certification• Continuing Education• E-learning• FMEA • Lean • Metrology• On-site

• Quality Tools and Multimedia• Quality Training• Self-directed Learning• Six -Sigma• SPC • Standards Training

Special Advertising Section

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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.

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For more information on the Automotive Warranty Management guideline or training, visit www.aiag.org or call us at (248)358-3003.

63September 2015 • QP

Standards and Auditing Guide

ANSI-ASQ National Accreditation Board600 N. Plankinton Ave., Suite 300Milwaukee, WI 53203Phone: 800-606-5394www.anab.org

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.

ANSI-ASQ National Accreditation Board’s areas of expertise include:• Metrology• On-site• Quality Audits• Quality Training

• Standards Registrars• Standards Training• Other – Accreditation

ASQ600 N. Plankinton Ave.Milwaukee, WI 53203Phone: 800-248-1946www.asq.org/standards

ASQ has the latest quality standards and standards-related products, all of which are available at a special discounted price for our members. Whether you’re 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.

ASQ’s areas of expertise include:• Certification• Conferences• Continuing Education

• Quality Audits• Standards Training

2015 INTERNATIONAL CONFERENCE ON QUALITY STANDARDSNovember 9 – 10, 2015 | Indianapolis, IN

Special Advertising Section

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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.

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64 QP • www.qualityprogress.com

Interested in being an exhibitor at the ICQS? Call Lou at 866-277-5666, or email him at mediasales@asq.org.

Target Audience• Auditors• Quality Assurance Specialists • Quality Engineers• Quality Managers• Supervisors

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Digital amplifierMahr Federal’s digital IC amplifier, the

Millimar C1200, allows users to view the

analog scale and numeric digital readings.

Its display range is ±5000 µm and reading

resolution 0.1 µm.

The C1200 is powered by rechargeable

batteries or an external power supply.

When battery operated, the compact unit

is fully portable.

Operating features are set up using an

integrated five-button keypad. Features

such as unit selection, normal/reverse po-

larity, measuring range, preset, factor and

tolerance entry are easily set up by visual

menu options. When tolerances are used

the display shows a pass/fail status using

a green/red color on the backlit display.

• Call: 800-343-2050.

• Visit: www.mahr.com.

Flange protectionFlange Armour provides full flange and

raised-face protection for industries in-

volved with the production of flanges of

any type and size.

Flange Armour pro-

tects flange faces

during fabrication,

site delivery, instal-

lation and storage.

One of the main

root causes for flange

damage is the use of

hand tools during the

fabrication and com-

missioning stages of

the product. Flange

Armour prevents

flange face defects

and damage and

improves production

performance. Flange Armour also reduces

the need for flange re-facing.

• Call: 844-693-1073.

• Visit: www.flangearmour.com.

Tube drawing systemSonobond Ultrasonics has re-

leased a tube drawing system

designed to

accommodate

manufacturers

of fine metal

tubing used in

syringe needles. It is also

for medical devices and

tubing products used in

industries that transport

critical fluids.

In an ultrasonic system,

a power supply converts

line power to high-voltage,

high-frequency electrical

power needed to drive the

transducer.

The transducer converts electrical en-

ergy to vibratory energy. The waveguides

are designed to resonate at the frequen-

cy of operation of the power supply and

transducer.

Ultrasonically drawn fine tubing is

used to produce: implantable device

components; in vitro diagnostic probes;

bands for catheters and guidewires;

heat-exchanger tubes for controlling

blood temperature during surgery; micro-

surgical tools; stents; and other devices

requiring tubing with a fine internal

dimension finish.

• Call: 800-323-1269.

• Visit: www.sonbondultrasonics.com.

QP • www.qualityprogress.com66

•

•

•

QPTOOLBOX

September 2015 • QP 67

Transmitter

The Model 4020LT-A two-wire transmitter

from Cosasco provides enhanced resolu-

tion measurements of metal loss due to

corrosion inside pipelines. The transmit-

ter is designed for operation in plant

locations with widely separated monitor-

ing points and a preexisting distributed

control system.

The Model 4020LT-A features mea-

surement resolution to ±0.1%, allowing a

timely response to corrosion rate spikes.

The transmitter has an available NEMA

4x-rated stainless steel enclosure for op-

eration in harsh environments. A switch-

able probe-type selector allows users to

adjust between different Corrosometer

electrical resistance probe types.

• Call: 800-635-6898.

• Visit: www.cosasco.com.

VideoscopeOlympus has introduced the Series

C industrial videoscope designed for

inspections of manufactured parts,

structures or areas that have limited

direct visual access. The Series C

videoscope features advanced ar-

ticulation and high-resolution image

quality. It captures still images and

videos with desired brightness.

The videoscope’s flexible distal tip

and a proprietary spring neck design

reduces stress when navigated

through tight bends or sharply curved

spaces. Articulation is made possible by

the thumb-driven joystick on the unit

that controls 360° articulation of the

distal tip and up to 120° angulation.

A protective replaceable cap added

to the distal end tip of the insertion tube

protects the LED light source

and the video camera when

used in harsh environments. The

Series C videoscope is suit-

able for routine and specialized

inspections.

• Call: 781-419-3562.

• Visit: www.olympus-ims.com.

Laser diode modulesOSI Systems’ SCW 1430 laser

diode module series is specifi-

cally designed for optical test

applications such as optical

time-domain reflectometers

(OTDR) and optical spectrum

analyzers.

The SCW 1430 product series

features pulse drift performance

and high stability. The modules

come in four package types. The

series is RoHS compliant and the high-

peak pulsed laser diode modules operate

typically at a center wavelength.

The SCW 1430 product series are

intended for optical testing applications

where high-peak pulsed optical power

is required. The higher power offers

greater dynamic range capability to OTDR

manufacturers.

• Call: 732-516-6520.

• Visit: www.laserdiode.com.

GOT A QUALITY PRODUCT?Send your product description and photo to vellifson@asq.org.

•

••

QP • www.qualityprogress.com

The Certified Quality Improvement Associate Handbook: Basic Quality Principles and PracticesRussell T. Westcott and Grace L. Duffy, ASQ

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

$105 list (third edition, book).

This book serves

as a valuable

source of informa-

tion pertaining to

quality concepts,

quality improve-

ment and continu-

ous improvement.

The information

is presented in

five units, each dedicated to an important

aspect of quality improvement. The book

begins with detailed explanations of the

key concepts and definitions pertaining to

quality, and then discusses the benefits of

quality improvement and employee involve-

ment in quality improvement efforts.

There is a chapter dedicated to the phi-

losophies of the quality gurus. This chapter

contains valuable information regarding

the way the quality leaders viewed quality

and continuous improvement, and it also

presents their contributions to the quality

movement.

Recognizing that employee involvement

is the key to the success of any quality

improvement project, the book’s second

unit has two chapters dedicated to under-

standing how employees work in teams,

and the key issues involved in team forma-

tion and group dynamics. The third unit is

devoted to the tools and techniques used

in continuous improvement and process

improvement projects. There are elaborate

explanations with suitable examples for the

most commonly used quality tools.

We live in an era of outsourcing and

offshoring. Recognizing this, there is a unit

dedicated to customer-supplier relation-

ships. There is also a nice discussion

about the process of supply chains, which

includes key supply chain metrics. The

last unit on system integration discusses

the view of the organization as a system

and distinguishes the process view from

the systems view. It emphasizes taking a

systems view of quality improvement.

This book is written in simple and

easy-to-understand language such that

readers with little or no knowledge of

quality concepts can understand and apply

quality tools with confidence. This book will

serve as a valuable reference for everyone

involved in the quality engineering and

quality management industry.

Rangarajan Parthasarathy

Harvard, IL

Reliability of Large and Complex SystemsKrzysztof Kolowrocki, Elsevier Insights,

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

The book assumes

readers are famil-

iar with a number

of underlying prin-

ciples of concepts

such as reliability,

calculus and how

to devise formulas

that represent

multifaceted

mechanical and

electrical systems. It is clearly aimed at the

more experienced reader and dives into

the world of complex systems, higher-level

math, and a continuous series of analysis,

system breakdowns and variations of sys-

tem arrangements and performance.

Easy to read but challenging in terms of

the analysis and math, the author guides

the reader from basic systems up to large,

complex and multistate systems and uses

a consistent set of examples based on an

iterative approach.

Other systems are discussed, such as

large hierarchal systems, and there is a

chapter on process modeling. In discuss-

ing large, complex systems, the author

uses the asymptotic approach along with

several examples.

The book is a highly detailed assemblage

of mathematics and research built around

a logical but comprehensive bibliogra-

phy. Elsevier specializes in technical and

leading-edge books, and this is representa-

tive of that high standard. Please note that

while this is a truly challenging topic it is

also logical, highly polished and thoroughly

researched.

Frank Pokrop

San Diego

How to Succeed With Continuous Improvement: A Primer for Becoming the Best in the WorldJoakim Ahlström, McGraw-Hill Education,

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

Big efforts often fail because no one feels

responsible for major changes. That’s why

the most successful companies focus on

improving the small things, which together

add up to major paybacks. While this book

is comprehensive and easy to read, it does

not focus on a specific industry or sector.

Simply solving a problem is continu-

ous improvement. The method of problem

solving and achieving improvement is not

QPREVIEWS

68

important. This book discusses the FISHY

method for problem solving and provides

many examples. The FISHY method entails:

1. Formulate the question.

2. Individual work.

3. Spread out the notes.

4. Have consensus through voting.

5. Your to-do list is introduced.

The book includes success factors for

improvement work and practical advice on

how to start and

maintain momen-

tum. It features

a questionnaire

for determining

the current state

of a problem, a

reference guide

for completing

fishbone diagrams

in 15 minutes and

an additional reading list.

When you do not take time to make

improvement, you do not get better. Every

business will gain from following the

author’s well-considered methods and

recommendations.

Marc A. Feldman

Houston

Models at Work: A Practitioner’s Guide to Risk ManagementJawwad 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 practitioner’s approach to

risk management by developing simple

models and testing them to understand the

limitations and breaking points.

The book is broken into four sections

building from an understanding of risk;

to simple Monte Carlo simulations in MS

Excel; to applica-

tions in fixed income

and commodities; to

a review of the prod-

uct universe driving

risk. The risk section

focuses on com-

plexity of analysis

versus complexity of

models, dealing with

volatility, target accounts for managing risk

along with risk policy and risk regulation.

The Monte Carlo simulation section de-

velops simplified MS Excel pricing models

and takes a layered approach to evaluate

the effect of changes in prices on business

and performance metrics. The fixed income

and commodities section includes applica-

tion examples that focus on identification

of relationships, drivers and data across

commodity markets. Finally, the last section

provides a broad review of the product

universe, pricing and valuation models.

The book is well-written and follows a

logical progression. There are many exam-

ples from the author’s extensive work and

research to demonstrate application. The

book also includes exercises and questions

making it an excellent resource in an edu-

cational environment. A glossary of terms,

an index and reference material make this

a good starting point for self-education.

The focus of this book is the corporate

risk-management professional. However,

any person interested in using models to

better understand and manage risk—par-

ticularly in the financial arena—will find this

book interesting.

Bryan Ruggles

Everett, WA

RECENT RELEASES Configuration Management For Senior ManagersFrank B. Watts, Butterworth Heinemann,

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

Quality Management in a Lean Health Care EnvironmentDaniel Collins and Melissa Mannon,

Business Expert Press, 2015, 120 pp.,

$59.95 (book).

69

Advertisers IndexADVERTISER PAGE PHONE WEB AIAG 63 248-358-3003 www.aiag.org

CyberMetrics Corp. OBC 800-777-7020 www.cybermetrics.com

EtQ Inc. IFC 516-293-0949 www.etq.com

Minitab inc. 1 800-448-3555 www.minitab.com

The National Graduate School 57 800-838-2580 www.ngs.edu

Quality Council of Indiana 10, 11 800-660-4215 www.qualitycouncil.com

The Quality Show 2 847-405-4053 www.qualityshow.com

September 2015 • QP

QP • www.qualityprogress.com70

PROFESSIONALSERVICESFor information on placing an ad, contact Media Sales at 866-277-5666.

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

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research by visiting

globalstateofquality.org.

The Global Voice of QualityTMCERTIFICATION MEMBERSHIP PUBLICATIONSTRAINING CONFERENCES

2THE ASQ GLOBAL STATE OF QUALITY

RESEARCH

Your Participation Is Needed

See the Full Spectrum Monitoring the effectiveness of corrective actions

TO ELIMINATE FAULTS from reap-

pearing, fault data spectrum (FDS) is a

tool that can monitor the effectiveness

of corrective actions (CA) on a continu-

ous basis. An FDS visually displays the

effectiveness of your CAs. If faults still

occur after CAs are implemented, your

organization will catch them early enough

to regroup the CA teams for additional

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

conduct proper root cause analyses and to

create fully effective CAs.

A fault can occur in a process or

product component if its parameters

deviate beyond the permissible limits of

its designed intent. A process fault could

happen due to high dispersion and can be

controlled by the process and machine

parameters. Process faults ultimately lead

to faulty products.

A fault also may result if the desired

output is not achieved with the intended

design input. Faults due to design inad-

equacy are highly repetitive in nature (see

Online Figure 1, found on this column’s

webpage at www.qualityprogress.com).

Faults are not created equal. The im-

pact of a few could have catastrophic ef-

fects on the product, such as safety faults.

Other types may occur in large numbers

and not be noticed by customers and only

by highly critical inspectors. These faults

don’t have any affect on functionality or

reliability and could be resolved through

simple changes to a process or material.

This is why faults need classifications.

Acceptance quality levels (AQL) can be

decided for different categories of faults

based on the criticality of the product.

Critical healthcare equipment, for ex-

ample, will have a rigid AQL.

Faults are classified, coded and later

traced in the field (see Online Table 1),

and the fault codes are created during

development stages.

A PDCA cycle is used for CAs, and the

cycle should be

short and effec-

tive. If it isn’t, it

will require anoth-

er cycle and cause

delays. A main

cause of customer

dissatisfaction

is repeated inef-

fective CAs (see

Online Figure 2).

FDS is a tool

consisting of fault

classifications

with a positive

control plan (also

called a positrol)

in a grid struc-

ture. The tool

uses an FDS grid

and a positrol grid.

The FDS grid (see Table 1) contains

fault codes and product serial numbers

or production batch numbers. In each

column, it color codes the implementa-

tion of CAs with reference to the affected

product serial numbers. After the imple-

mentation of CAs, the faults should taper

off drastically or disappear.

For faults F1 and F2, for example, a CA

was taken after product 226, but the ac-

tion was only partially effective and didn’t

completely eliminate complaints. After

another PDCA cycle occurred at product

326, the faults didn’t recur in 2,700 prod-

ucts sold.

The additional PDCA cycle did,

however, consume production time that

was equivalent to 100 products manufac-

tured—a costly lapse for the organization.

Faults three, four, five, seven and eight

showed CAs that were done right the first

time, and the actions were described in

a positrol sheet shown in Online Table 2.

For additional examples of FDS and posi-

trol grids that were used on a manufactur-

ing process for a hair dryer with five major

faults, see Online Tables 3 and 4.

FDS and fault classification are linked

and able to take actions upstream at tier

one, two and three supplier levels. They

can be used during development phases,

and each failure that’s encountered in

alpha, beta or pilot production is made

visible for an easier and more effective

resolution. QP

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.

ONE GOOD IDEA BY UMESH KRISHNAPPA

September 2015 • QP 71

Fault data spectrum for XXXX assembly80 41 13 5 6 3 5 4 3

476–3,000401–475376–400351–375326–350 1301–325 1 1276–300 1251–275 1 1226–250 1 3201–225 1 1 1 1176–200 6 1151–175 4 1 2 1 1126–150 7 2 2 2101–125 2 1 1 176–100 13 2 1 151–75 1 1 1 126–50 1 2 1 10–25 5 1

Total

Production batchFault types

F1–Fault 1 F2–Fault 2 F3–Fault 3 F4–Fault 4 F5–Fault 5 F6–Fault 6 F7–Fault 7 F8–Fault 8

xxxx not opening

with yyyy

xxxx not opening with zzzz

xx/yy not opening

from inside

xx/yy not opening

from outside

xxxx noise (abcd loose)

nnnn failures

xxxx switch failure

White dot mark

Final effective solution

Interim action— not fully effective

Containment action

FDS of a subsystem with fault codes and factual data for up to 3,000 units sold / TABLE 1

FDS = fault data spectrum

QP • www.qualityprogress.com72

Just Do ItQuality organizations don’t always need certifications

SOME ORGANIZATIONS with certifi-

cations from the International Organiza-

tion for Standardization (ISO) do not

deliver high-quality products, and yet,

organizations without these certifica-

tions sometimes provide amazing levels

of quality. Why is that?

The goal of any organization is to

provide excellent quality products and

services to its customers to earn their

loyalty and repeat business. It’s tradi-

tionally understood that organizations

possessing ISO certifications are the

best of the best. Sadly, this isn’t always

the case, and sometimes even the op-

posite is true.

It would be a mistake to discount

the importance of these certifications,

but you also should consider that some

organizations don’t subscribe to these

standards, and their customers’ ratings

show they’re superior to their certified

counterparts. This is because they un-

derstand what it takes to be successful

without all of the policies, procedures,

work instructions and reams of docu-

mentation.

How do these organizations become

so successful? They listen, respond,

improve and start over again. They

stay current with customers’ needs and

expectations, study their competition

and replicate best practices, and adapt to

changing conditions. In other words: they

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

Whether the PDCA cycle is known to

an organization or not, it’s often intui-

tively implemented by smart, enterprising

people who know how to succeed without

all the charts, graphs and documented

management reviews. Instead of getting

caught up on collecting paper (known as

objective evidence to quality auditors),

they just do it. There are two real-world

examples I frequently encounter that

illustrate organizations just doing it, not

overdoing it.

Consistent satisfactionWhen I visit Mike’s Deli near my office,

there’s usually a line of customers in front

of the building before it opens. When the

doors open, people flock inside.

One person takes your order and

gives you a number, and another

person works the cash register.

You get a beverage at the drink

station and sit down while your

food is prepared. Within minutes,

your number is called, and you’re

eating.

Regardless of how busy it is,

the service is consistently great,

the food is fresh and prepared

exactly how you requested, and

you’re out the door in 20 minutes.

As you leave, the owner greets you

and thanks you for your business.

Service with a cookieI’ve gone to the local eye institute for

several years. When I step inside, friendly

people are ready to help me at the front

desk. The atmosphere is pleasant, and

there are color-coordinated walls, carpet-

ing and seating arrangements showing me

where to find my doctor.

The service is fast, and everyone has

a clearly defined job. Free coffee and

tea are available at strategically located

stations, and there’s even a staff member

who walks around with a tray of warm

cookies. “Have a cookie please,” she

says. “They’re delicious.”

Another staffer engages and consoles

some of the older patients. For patients

who need assistance, a courtesy van

waits outside to take them home.

Great customer service is just one

piece of the quality puzzle, but many

elements of the ISO 9001 standard are

represented in these examples, such as:

execution to management responsibility,

customer focus, planning, provision of

resources, infrastructure, consideration

of work environment, product realiza-

tion and data analysis.

Don’t get caught up on quality certi-

fications alone, and look deeper into an

organization as a whole. Everyone can

learn from everybody whether they hold

certifications—or not. QP

BACK TO BASICS BY RICK TOWNSLEY

RICK TOWNSLEY is a quality manage-ment systems advisor at Resource International in Redington Shores, FL. He holds a doctorate in business ad-ministration from Kennedy-Western University in Cheyenne, WY. A senior ASQ member, Townsley is an ASQ-certified quality auditor, engineer and

manager of quality/organizational excellence.

The revised ISO 9001 standard will be published in fall 2015. But, don’t wait to get a jump-start on your training, auditing, and more to become certified to the new standard!

The ISO/FDIS 9000:2015 and ISO/FDIS 9001:2015 are now available for purchase!

To get started, and to learn more, visit asq.org/aboutstandards.

Remember to always stay connected to ASQ through the 3 C’s of standards.

ISO/FDIS 9000:2015 and ISO/FDIS 9001:2015

The Global Voice of QualityTMCERTIFICATION MEMBERSHIP PUBLICATIONSTRAINING CONFERENCES

asq.org/standardsconnection asq.org/standards/videos.asq.org/asq-standards-channel

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