Full Issue

QUALITY PROGRESS | SEPTEMBER 2015

P

Putting Best Practices to Work

www.qualityprogress.com | September 2015

The Ishikawa

Family Legacy

p. 46

QUALITY

IS0 9001:2015

KEEP CALM AND

PREPARE FOR ISO 9001:2015 Let our experts help

Plus: VOLUME 48/NUMBER 9

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

TM

Retool audits using the Kano model p. 38

p. 18

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

FEATURES 18

STANDARDS

Keep Calm and Prepare for ISO 9001:2015

SOFTWARE QUALITY

A Hard Look at Software Quality

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

by Moisés Rodríguez, Mario Piattini and Carlos Manuel Fernández

38

AUDITING

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

HISTORY

Like Father, Like Son

A look back at the lasting contributions Ichiro Ishikawa and Kaoru Ishikawa made to total quality management and the world of quality.

by Gregory H. Watson

38

AND

PREPARE FOR ISO 9001:2015

ONLY @

www.qualityprogress.com

Amazing Audits

by Lance B. Coleman Sr.

46

KEEP CALM

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

by Bill Aston, Susan L.K. Briggs, Charles A. Cianfrani, Deann Desai, Allen Gluck, Paul C. Palmes, Denise Robitaille and John E. “Jack” West

30

18

• Small Business Challenge

A sidebar for this 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.



More figures to illustrate how to evaluate your audit programs, the subject of “Amazing Audits,” pp. 38-45.

• Audit Add-Ons

• Stay in the Loop

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

• Back to Basics

Translated into Spanish.

• Talk Back

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

QP

DEPARTMENTS 6

LogOn

8

Expert Answers

12

• Advice on developing high-quality suppliers.

12

QUALITY PROGRESS

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

Mail

Quality Progress/ASQ 600 N. Plankinton Ave. Milwaukee, WI 53203 Telephone Fax 800-248-1946 414-272-1734 414-272-8575

Keeping Current

• Dealing with drones.

Email

14

Mr. Pareto Head

Follow protocol of first initial and full last name followed by @asq.org (for example, [email protected]).

66

QP Toolbox

Article Submissions

68

QP Reviews

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

COLUMNS 5 53 56

Up Front

Stress relief.

Measure for Measure

Updates needed to the occupation classification list.

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

58

Author Guidelines

58

Career Corner

In job searches, do your homework on prospective employers.

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

60

Statistics Roundtable

Photocopying Authorization

71

One Good Idea

72

Including nuisance factors during experimentation. Using fault data spectrums to check corrective actions. BONUS

Back to Basics

Are standard certifications always necessary?

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

Photocopies, Reprints And Microform

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

NEXT MONTH

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

- SUPPLIER DEVELOPMENT

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

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. 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.

4

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

Membership and Subscriptions

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UPFRONT

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QUALITY PROGRESS

Stress Relief

EXECUTIVE EDITOR AND ASSOCIATE PUBLISHER

Handy primer on the ISO 9001 revision

Mark Edmund

Seiche Sanders

ASSOCIATE EDITOR ASSISTANT EDITOR

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

Amanda Hankel

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

MANUSCRIPT COORDINATOR

wait is over, now the clock starts 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

Valerie Ellifson

COPY EDITOR Susan E. Daniels

CONTRIBUTING EDITOR Tyler Gaskill

ART DIRECTOR Mary Uttech

GRAPHIC DESIGNER Sandy Wyss

PRODUCTION

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

Cathy Milquet

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

ADVERTISING PRODUCTION

This 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 evaluation form is provided to produce a ranking that is incorporated into the Kano model and used to improve internal audit performance.

Barbara Mitrovic

DIGITAL PRODUCTION SPECIALISTS Julie Stroik Julie Wagner

MEDIA SALES Naylor LLC Lou Brandow Krys D’Antonio Norbert Musial

MEDIA SALES ADMINISTRATOR 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

Kathy Thomas

MARKETING ADMINISTRATOR Matt Meinholz

EDITORIAL OFFICES

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

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

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

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

Phone: 866-277-5666

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

ASQ ADMINISTRATION

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

William J. Troy

CEO

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

Seiche Sanders Editor

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

September 2015 • QP

5

LOGON Seen&Heard Helping suppliers improve

next year when an auditor finds that one

In response to “Back to Basics: Sufficient

clause everyone else overlooked.

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

Tom Fessenden

reer as a computer components software

P

Putting Best Practices to Work

QUALITY PROGRESS | AUGUST 2015

quality engineer, I developed and used an audit checklist to identify risks. This created

Cypress, TX www.qualityprogress.com | August 2015

Driving Creativity

With DoE

p. 20

QUALITY PROGRESS

CREATIVITY SPARKS INNOVATION

a profile of the prospective suppliers’ strengths and weaknesses. We then worked with the chosen supplier to

Person: Substandard Training” Plus: Restaurants ramp up table-side technology p. 10 Quality and social responsibility cross paths p. 26

VOLUME 48/NUMBER 8

strengthen its weaknesses.

Clearing up misunderstandings In response to “Quality in the First

Cultivating Creativity Organizational restructuring to optimize innovation p. 14

The Global Voice of Quality

(July 2015, pp. 46-47): Very good description of a (continuing) misapplication of the idea of

TM

We also put in place incoming

standardization of quality processes.

inspections and testing as contingency

Even now, I am dismayed at the number of

measures to protect our organization

offerings to help people “avoid mistakes in

from the supplier’s weaknesses.

interpretation” of the new version of the ISO

The results from our inspections and testing were communicated back to the supplier to further drive its improvement

9001 standard. If the standard isn’t selfevidently clear, it isn’t written well. Certification will require agreement

efforts. The supplier, in turn, communi-

with the auditor—so if you need any help

cated its testing results to help identify

at all, you should ask the auditor. Indepen-

any test correlation issues.

dent verifications are fine, but I still believe

As our inspection and test data im-

the market is the best indicator of quality

proved, we reduced, then dropped, our

success. If you satisfy the customers (with

incoming inspections. We only monitored

whatever your system is), you will do better

the final system test results and our

than your competition.

customer feedback to verify acceptable

Steven Cooke

quality and reliability. It was a lot of work,

Charlotte, NC

but it resulted in developing low-cost, high-quality suppliers.

Jargon included

Duane Briggs

In response to “Blank-Slate State” (May

Lexington, SC

2015, pp. 50-51): This matches my style exactly when creating a quality management

6

Plenty still unknown

system. The only thing I do differently is

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

regarding “regulatory vomit.” I include this

provided good but incomplete information

jargon so the person being audited will not

on an unknown entity (ISO 9001:2015).

be intimidated when the auditor uses it.

The author has provided a little more light

For example, “Show me your procedure for

onto the shadowed outline of this critical

product realization.”

subject. I don’t think we will really know

Rick Paul

what this new revision is until sometime

Escondido, CA

QP • www.qualityprogress.com

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

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

Executive Editor & Associate Publisher Seiche Sanders: @ASQ_Seiche

Associate Editor Mark Edmund: @ASQ_Mark Assistant Editor Amanda Hankel: @ASQ_Amanda Contributing Editor Tyler Gaskill: @ASQ_Tyler [email protected] www.facebook.com/ groups/43461176682

www.linkedin.com/groups/qualityprogress-magazine-asq-1878386

QP

ONLINE EXTRAS@

QP

QUALITY PROGRESS

www.qualityprogress.com

Videos feature ISO 9001:2015 experts

Most of the authors of this 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 victim

In his Standards Connection enewsletter article, “Avoiding Misinterpretation Quicksand,” expert John Guzik clears up potential misunderstandings in the new version of ISO 9001. Read the article at http://tinyurl.com/iso9001quicksand and subscribe to the enewsletter at asq.org/standardsconnection.

QUICK POLL RESULTS

Each month at www.qualityprogress.com, visitors can take an informal survey. Here are the numbers from last month‘s Quick Poll: What is your organization’s biggest barrier to creativity?

9%

40.9%

13.6% 36.3%

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.

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.

QualityNewsTODAY

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

First 3-D-Printed Drug Approved by FDA 3-D printing allows the pill to deliver a higher dosage of medicine—up to 1,000 milligrams—while being porous enough to dissolve quickly. These attributes can particularly benefit patients who have difficulty swallowing their medication and miss doses of treatment. (http://tinyurl.com/3ddrug) New Breed of Software Engineers Join Automotive Industry To cope with the software engineer shortage in the automotive industry, suppliers such as Visteon Corp. are turning to unconventional sources—such as the movie and video game industries—to recruit people. (http://tinyurl.com/autosofteng)

PAST CHAIR

Stephen K. Hacker, Transformation Systems International, LLC

CHAIR

Cecilia Kimberlin, Kimberlin LLC (retired – Abbott)

CHAIR-ELECT

Patricia La Londe, CareFusion

TREASURER

Eric Hayler, BMW Manufacturing

SECRETARY

William J. Troy, ASQ

PARLIAMENTARIAN Sue Campbell, ASQ

DIRECTORS

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

QP EDITORIAL REVIEW BOARD Randy Brull, chair

Administrative Committee

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

Technical Reviewers

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

WANT THE LATEST QUALITY-RELATED NEWS AND ANALYSIS? The QNT Weekly enewsletter, available exclusively to ASQ members, delivers it every Friday. Subscribe now at http://email.asq.org/subscribe/qntwk.

September 2015 • QP

7

EXPERTANSWE Business success with ISO 9001

tion. Often, organizations don’t account for

Selecting consultants, registrars

Q: If an organization wants to implement ISO 9001 for the first time, what is the first step?

these costs because they are less likely to

Q: What are the qualities to look for when

get caught by a regulatory body. This isn’t

selecting an ISO 9001 consultant and

a sustainable business practice, however,

registrar?

A: Use the organization’s purpose as a

because when it comes time to pay for

starting point. Too often, organizations try

one of these expenses, the money needed

A: This question is timely because the

to appease or conquer requirements as

hasn’t been accounted for in the budget or

ISO 9001 and ISO 14001 revisions are

if the end-goal is to satisfy those require-

pricing structure.

scheduled to be released in September

ments.

After you have accounted for everything

2015. Many organizations planning to

to run your business, think in terms of

use external-expert help in implementing

primary purpose (for example, to make

planning to succeed. Risk-based thinking,

their management systems and that are

money through the product or service

management review and data analysis are

planning to find a registrar to register their

offered or to effectively use the available

great for this because they are intended

management systems will find this answer

resources to promote educational excel-

to help you assess actions already taken

useful. This is an important question

lence) means the organization may create

to determine whether further action is

because choosing the right consultant is

a competition between the requirements,

needed. In essence, the organization is

critical to accomplishing organizational ob-

such as those in ISO 9001, and its organiza-

either already suitably established, ad-

jectives on time and on budget. Choosing

tional purpose.

equately addresses all requirements, and

the right registrar is even more important

is effectively driving behavior, or it has the

because you likely will stay with the same

information and action plan to get there.

registrar for several years to come.

cused on what is important without getting

Q: How should an organization approach ISO

Choosing a consultant

lost in the euphoria of becoming certified to

9001:2015 to make it work for its business?

ISO 10019:2005 defines a quality manage-

Not staying true to the organization’s

Using who you are as a business as the reference point for implementing requirements will help the organization stay fo-

ment system (QMS) consultant as a “per-

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

son who assists the organization on QMS

Q: How do you determine what is nec-

the business instead of trying to make the

realization, giving advice or information.”1

essary for a business to continue to be

business fit the standard. In other words,

This standard further recommends the

successful in the future? How can ISO

many organizations usually take the stan-

following attributes be considered when

9001:2015 be helpful in doing this?

dard and go through it clause by clause. To

selecting QMS consultants:

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

tributes recommended by the standard,

function as a business (organization) to

and plug in the standard’s clauses where

being ethical is a key attribute. An unethi-

make money or receive funding today.

they apply to the organization.

cal consultant can cause more damage to

After you understand this, you can evaluate the true cost of sustaining this.

This may mean a clause is accounted

the organization than an incompetent

for in more than one place in the docu-

consultant. Organizations should check the

mented system. That is actually a good

consultant’s past projects with clients to

facilities, materials and labor to produce

thing because you are dealing with the

ensure there isn’t any unfavorable feedback.

your product or service, don’t forget about

organization’s reality instead of simply ap-

Other personal attributes to look for include:

less-frequent expenses, such as main-

peasing the standard.

observant, perceptive, versatile, tenacious,

While some costs are obvious, such as

tenance costs, licenses or certifications required to do business, and any other costs related to sustaining the organiza-

8

Ethics. Among the many personal at-

A: Start by considering what it takes to

QP • www.qualityprogress.com

Robert Freeman President, Practical Perspectives McKinney, TX

decisive, self-reliant, communicative, practical, accountable and facilitative. Experience. The consultant should be

RS Look at the standard through the eyes of the business instead of trying to make the business fit the standard. able to understand the organization’s

knowledge and overall work experience,

organization operates and your customer

context and situation and provide creative

including previous roles in quality and

prefers. Most importantly, your registrar

solutions. This comes from experience

operations management.

should have local auditors who have

in working with different-sized organiza-

solid industry knowledge and experience

tions, in various industry segments and

Choosing a registrar

in addition to proven audit experience.

geographic locations, and on projects with

Organizations do not frequently change

If they must send auditors to you from

varying complexity such as providing low-

registrars, so selecting one requires a care-

other regions and geographies to meet

cost, high-value solutions for resource-

ful review. Knowledgeable customers care

auditor skill requirements, it will cost the

constrained small business clients.

about who issued your QMS certification,

organization hefty travel and administra-

so it is important to consider the registrar’s

tive expenses year after year.

Education and knowledge. The consultant should not only have the right

reputation. Reputation of an organization is

level of education, he or she also should

often an indirect measure of the quality of

quality of the registrar’s audit and the

have the necessary skills to understand

its products and services over time.

value added to the organization.

products and services. They should have

If your organization has several locations

Ask customer references about the

Finally, consider overall audit cost. Ask

knowledge of all the relevant management

in a country or around the world, ensure

for the cost breakdown to understand the

systems standards and other international

that the registrar has branches and a global

typical estimated cost for an audit cycle

standards required to implement the sys-

presence to support your needs. If your

(typically three years). This should include

tem well. Examples include sector-specific,

organization plans to become certified to

details such as the audit fee, annual file

accreditation and product standards, as

additional management systems stan-

maintenance, audit cancellation fee, annual

well as safety-related standards.

dards, such as ISO 14001, OHSAS 18001 or

escalation fee and auditor travel expenses.

The consultant should have expertise

industry standards, ensure that the registrar

The registrar should be responsive to the

or working-level experience in project

carries these certifications and that the

client’s needs and provide flexibility with

management and quality management

auditors are qualified to audit to multiple

scheduling audits. It may be a good idea to

principles, methods and techniques.

standards. This will allow you to conduct an

ask the shortlisted registrar to conduct a

Implementing the project may require the

integrated management systems audit with

pre-assessment to verify its capability be-

use of quality engineering tools, statistical

the help of a single registrar.

fore committing to a long-term relationship.

techniques, problem solving, risk management and change management. Other aspects to consider are industry

The registrar’s accreditation body also

Govind Ramu

matters. Find out if the accreditation body

Director, quality assurance

is recognized in the regions where your

SunPower Corp. San Jose, CA

AT YOUR SERVICE

Let 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 [email protected], and we will find an answer for you.

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

September 2015 • QP

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ISO Primer by Bensley & Wortman

by Greg Wies & Bert Scali

A convenient book for training internal auditors to the ISO 9001 expectations. An instructor CD is available.

Reliability & Maintenance Analyst CD by Bryan Dodson

Solve your Weibull, reliability, warranty, Bayesian & Maintenance, prediction & estimation problems.

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

Used by Chrysler, ITT, FedEx, Ford, TRW, GM, HP, U.S. Postal Service

ISO

Presents a thorough treatment of the ISO implementation and documentation process. There are generic manuals on the CD.

Quality System Handbook by Edenborough

QSH

Details the selection, organization, and writing of quality documents. The disk contains procedures and work instructions.

KEEPINGCURRE TECHNOLOGY

Drone Dilemma?

S

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

Farmers want to operate them to moni-

authorities, such as police, firefighters and

ago with plans to incorporate unmanned

tor crops and tailor their use of pesticides,

other first responders, also are expected to

aircraft systems (UAS) into its package

herbicides, fertilizers and other applications.

invest in the technology.5

delivery service, all sorts of industries have

Utilities are considering them to inspect

been abuzz about drones and brainstorm-

electric and gas lines in remote areas.

ing innovative ways to use this burgeoning technology.

“To me, the diversity of industries that

Addressing safety concerns Along with the excitement and enthusiasm

are coming forward in this initial phase [of

over drones, concerns about aviation safety

applying for FAA special permits] and saying

surrounding this advancing technology

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

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

persist.

ministration (FAA) to keep up with concerns

nificant element,” said Brian Wynne, CEO of

over safety?

the Association for Unmanned Vehicle Sys-

amples of disruptive drone activity:

tems International, a trade group. “We think

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

But is interest and usage in drones mov-

“The FAA has to act and toughen up the

Consider just a couple of recent ex-

rules before a tragedy occurs, be-

ternational Airport reported four

cause if a drone were sucked into

drone sightings within a three-

a jet engine of a plane filled with

day stretch in late July and early

passengers, untold tragedy could

August. Other reports of near

result, and we do not, do not, do

collisions between drones and

not want that to happen,” said Sen.

airplanes have been reported in

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

Austin, TX, and Minneapolis in

maker who wants the FAA to speed

recent months. FAA rules pro-

efforts to update regulations and close loopholes covering the use of drones.1

hibit drones from flying within there’s a ready-made market out there.”3 After the FAA establishes the guidelines

five miles of an airport and no higher than 400 feet.6

High commercial interest

for commercial use, the drone industry said

Already, the FAA has granted special permits

it expects more than 100,000 jobs to be

above flames and smoke from the for-

while it develops comprehensive rules to

created and nearly half a billion dollars in

est fires in July in California, forcing fire

govern how commercial drones should share

tax revenue to be generated collectively by

crews to ground water-dropping aircraft.

the sky with passenger planes. Proposed

2025.4

The delays allowed the fires to spread,

• Unmanned devices were spotted flying

rules for commercial drones were released

It’s also predicted that drone activity

resulting in devastating property losses.7

in February, and officials are now reviewing

could be worth tens of billions of dollars

FAA spokeswoman Elizabeth Isham Cory

thousands of public comments that were

to U.S. companies over the next decade as

said the agency receives about 60 reports

submitted. The FAA has granted 944 com-

demand for this technology rises. Organi-

from pilots each month alerting the agency

mercial drone permits as of July 28—with

zations are expected to spend money on

of drones flying too close to airports, air-

thousands more applications pending.2

drones to use for surveillance activities,

planes or helicopters.8

For instance, real estate businesses want

agriculture, weather and environmental

Some state and federal-level lawmak-

to use commercial drones to showcase

monitoring, oil and gas exploration, and

ers, as well as private companies, are

properties with videos taken from the air.

aerial imaging and mapping. Government

looking to take action to protect the skies

12 QP • www.qualityprogress.com

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

Q

Who’s Who in NAME: Himanshu Trivedi. RESIDENCE: Ahmedabad, India.

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

drones. The act would create federal regulations

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

regarding when, where and how consumer

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

drones can be operated, while requiring new safety technologies be built into all new drones. This includes collision-avoidance technology, transponders that signal a 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 consumer drones after they are purchased.10 Private companies: Amazon, too, has proposed a blueprint for a low-altitude air-traffic system, said Gur Kimchi, a vice president who heads the 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

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.

without hitting each other or threatening tradi-

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

tional aircraft is by requiring the equivalence of

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

flight plans to be filed and ensuring that drones (continues on p. 14)

September 2015 • QP 13

KEEPINGCURRENT Mr. Pareto Head

BY MIKE CROSSEN

Dealing with drones (continued from p. 13) communicate their positions to a centralized

REFERENCES

computer system available to all operators, ac-

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

cording to Kimchi.12 “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 life Aside from the concerns about collisions, some drone doubters bring up privacy and quality of life issues, envisioning swarms of drones interrupting sunsets while delivering packages or swooping across backyards to snap photos of unsuspecting sunbathers. Those concerns have the U.S. National Telecommunication and Information Administration hosting discussions on developing voluntary privacy standards for drones. “From enhancing news gathering, improving agribusiness and equipping new delivery models, to providing internet in remote areas, the possibilities for UAS are staggering,” said Angela Simpson, the 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,

14 QP • www.qualityprogress.com

associate editor

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 planning its “Design DoJo: Keeping Design Controls Practical and Compliant” conference Sept. 29-30 in Boulder, CO. Go to http://asq.org/biomed for information on the event. Finally, the second annual Joint Technical Communities Conference—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-clarifyunderstand-select (FOCUS)/plan-docheck-act (PDCA) model to determine root causes of unreported medication errors and identify potential improvements. Read the case study at http://tiny. cc/dubai-asq-case-study.

HEALTHCARE

ASQ JOURNAL SPOTLIGHT QP occasionally highlights an open-access article from one of 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 applies guidewords. Masao also uses standards and the example of the automobile for explanation purposes, but thinks this method applies to various domains. To access the 10-page article in PDF format, click on the “Current Issue” link on 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.

Software Quality Professional V O L U M E

S E V E N T E E N

•

I S S U E

T H R E E

•

J U N E

2 015

Implementing Functional Safety Standards

Richard Messnarz, Christian Kreiner, Andreas Riel, Bernhard Sechser, Klaudia Dussa-Ziegert, Risto Nevalainen, and Serge Tichkiewitch

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

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

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

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

www.asq.org

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

Sept. 17, 2013 Eiji Toyoda died at the age of 100 on this date. The well-known industrialist helped propel his 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 manufacturing methods. He returned and redesigned Toyota’s plants with advanced assembly techniques and machinery. The unique Toyota management approach had three main objectives: keeping inventory to a minimum through kanban or a “just in time” system, ensuring each assembly step is performed correctly the first time, and reducing the amount of human labor that went into assembling each vehicle. In 1967, Toyoda was named president of the automaker. Under his watch, Toyota sold an all-time high 1.7 million vehicles in Japan and 1.7 million vehicles overseas in 1985, and profits peaked at $2.1 billion. Toyoda stepped down as chairman of Toyota in 1994 at age 81. SOURCE: www.notablebiographies.com/St-Tr/Toyoda-Eiji.html (case sensitive).

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

September 2015 • QP 15

KEEPINGCURRENT SHORTRUNS

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

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

THE DEADLINE TO submit nominations

For more information about the celebration,

tion about the five-day event, visit www.

for next year’s Harry S. Hertz Leadership

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

ame.org/cincinnati.

for the long-time leader of the Baldrige

TO MARK WORLD Statistics Day on Oct.

THE ANSI-ASQ National Accreditation

Performance Excellence Program. For more

20, a data visualization competition is be-

Board has become the first accreditation

details about the award, the nomination

ing held by StatisticsView.com and John Wi-

program to offer the new international

process, award criteria and a list of the 11

ley & Sons Ltd. For more information about

featured standards (IFS) Food Store third-

selection committee members, visit www.

the competition, visit www.statisticsviews.

party retail inspection standard in the

baldrigefoundation.org.

com/view/WorldStatsDayComp.html (case

Americas. The IFS Food Store standard is

sensitive).

the only third-party inspection program

Award is Sept. 20. The award is named

THE U.S. CELEBRATION of World Standards

based on ISO/IEC 17020, which is currently

Day, an event that recognizes the critical

THE ASSOCIATION FOR Manufacturing

available from a leading global scheme

role of various stakeholders across the stan-

Excellence (AME) announced the eight key-

owner. For more information about the

dards community, including business lead-

note speakers who will be featured at its

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

ers, industry, academia and government,

annual AME Excellence Inside Conference

store-inspection.

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

2016 Quality Progress Editorial Calendar January

Back to Basics: “Best Of” Edition

February

Lean and Six Sigma

March

The Multi-Generational Workforce

April

The Cost of Quality

May

Risk

June

Change and Change Management

July

The QP Career Guide

August

Supply Chain and Stakeholders

September Benchmarking October

Standards and Auditing

November

40 Under 40

December

Salary Survey

If you want to write for a specific issue, make sure to submit your article three to six months before the issue date. That allows time for the article to be reviewed, revised and prepped for publication. 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.

P

QUALITY PROGRESS

16 QP • www.qualityprogress.com

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

Upcoming Application Deadline: October 16, 2015 Exam Date: December 5, 2015 For more information or to apply for an exam, visit asq.org/cert. TRAINING

CERTIFICATION

CONFERENCES

MEMBERSHIP

PUBLICATIONS

The Global Voice of Quality

TM

KEEP CALM AND

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

ISO 9001:2015

REVISIONS OF ISO management systems are often accompanied by a bit of anxiety. More than 1 million organizations have been certified to ISO 9001:2008, the international quality management system (QMS) standard, and they now must embark on implementing a revised version to be published later this month. Most organizations are on pins and needles: What are the key changes we must be aware of? When and how should we introduce the required changes? What resources will we need? The international technical advisory groups (TAG) to ISO Technical Committee 176, the group responsible for writing ISO 9001, have toiled to achieve the highest caliber revision. You can imagine how challenging it is to achieve a consensus among hundreds of individuals in dozens of countries, with multiple languages and cultures. This is why a 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 during 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 example, which arguably may be the most impactful change in ISO 9001:2015, is engrained in several aspects of the standard. In a perfect world, a revision for an established, internationally accepted standard such as ISO 9001 should be easier to read, learn and implement. It should provide noncontroversial, improved tools for quality management. Although our world is not yet perfect, ISO 9001:2015’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.

September 2015 • QP 19

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

DEANN DESAI is a project manager for Georgia 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 Accreditation Council of the ANSI/ASQ National Accreditation Board. Palmes is an ASQ-certified quality manager, British Standards Institution-certified ISO 9001 auditor and has a master’s degree in administration from Gonzaga University in Spokane, WA. DENISE ROBITAILLE is the author of 12 books, including ISO 9001:2008 for Small and Medium-Sized Businesses (ASQ Quality Press, 2010), and an internationally recognized speaker and trainer. She is an active member of TAG 176, where she has participated in the revision of multiple standards. Robitaille is an ASQ fellow, an Exemplar Global-certified lead assessor and an ASQ-certified quality auditor.

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

20 QP • www.qualityprogress.com

ISO 9001:2015

Prepare for a New Structure by Deann Desai and Susan L.K. Briggs What is the change?

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

The structure of ISO 9001 has been revised. Clauses and

core text, and common terms and core definitions.

subclauses are retitled and reordered according to a

There are 10 elements in the Annex SL high-level

high-level structure that allows for all management sys-

structure:

tem standards (MSS) to be aligned.

1. Scope.

To fully understand this change, some background

2. Normative references.

explaining why it was done should be helpful. From the

3. Terms and definitions.

early 1990s, the International Organization for Standard-

4. Context of the organization.

ization (ISO) technical committee for quality manage-

5. Leadership.

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

6. Planning.

vironmental management (ISO/TC 207) worked together

7. Support.

to enhance compatibility and avoid conflicting require-

8. Operation.

ments between ISO 9001 and ISO 14001, the internation-

9. Performance evaluation.

al environmental MSS.

10. Improvement.

In 2003, the ISO General Assembly received advice

These elements have driven the changes that users

from advisory and user groups that greater alignment of

will find in ISO 9001, including the restructuring of the

the structure—including clause sequence and require-

standard from eight clauses in the 2008 version to 10

ments in the standards—was desirable and achievable,

clauses in the 2015 version.3

and that this would benefit organizations implementing more than one MSS.

What do I need to do?

In 2005, the ISO Technical Management Board estab-

A frequently asked question about this change is: “Must

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

organizations renumber their documents and other rel-

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

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

veloped. Building on this, the group developed the MSS

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

requirements, which were published as Annex SL in the

but many organizations will choose to do so as a tracking

ISO/IEC Directives1, 2 in 2011.

mechanism—a way to keep things straight and ensure

Annex SL defines the high-level structure including

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

common text, terms and definitions along with guidance on

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

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

bering will remain the same in future revisions.

all ISO management system requirements standards will be

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

aligned, and ISO will seek to enhance the compatibility of

ing introduction of context of the organization and risk,

these standards through the promotion of identical:

came from the use of the high-level structure.

• Clause titles.

One of the key responses in the user survey conduct-

• Sequence of clause titles.

ed prior to writing the revision was that the connection

• Text.

with the larger, strategic view of the organization was

• Terms and definitions.

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

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

cept called the “context of the organization” addressed this concern. The intent of this clause is for organizations to have a high-level (strategic) understanding of the important is-

What does it mean?

sues that can affect a management system—positively or

The aim of Annex SL is to enhance the consistency and

negatively. Part of an organization’s context also includes

alignment of existing and future ISO MSSs by providing

relevant needs and expectations of interested parties that

September 2015 • QP 21

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

prevents or reduces undesired effects, and achieves

ested party requirements is used to guide the efforts to

continual improvement. Annex SL calls for actions to

plan, implement and operate a QMS.

address risks and opportunities in subclause 6.14 but

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

does not require risk management, risk assessment or risk treatment.

the section on planning. The organization plans how

The addition of these two strategic business pro-

it will address any negative or positive consequence

cesses were included to encourage an organization’s

posed by these issues and requirements in a prioritized

top management to become more actively engaged,

fashion in its QMS.

ensuring the QMS takes a more strategic view and is

The purpose of planning is for an organization to

integrated into its business processes, with the overall

anticipate potential scenarios and consequences, and

intent to promote improved performance of the QMS.

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

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

Understand Your Context by John E. “Jack” West and Charles A. Cianfrani What is the change?

direction, and to monitor and review information re-

The latest edition of ISO 9001 contains content that will

lated to these external and internal issues.

appear new to some users. The newness of the content

These requirements inject a QMS into an organiza-

will vary widely among organizations depending on

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

their existing QMSs. An organization’s prior compli-

termine external and internal issues that are relevant to

ance could have ranged from the absolute minimum

its purpose and its strategic direction,”2 an organization

to deployment of processes that address the explicit

must know its strategic direction.

requirements and the intent of the latest requirements.

This clause introduces the concept of requiring an

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

organization to think at strategic and tactical levels

organization, therefore may require a widely different

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

range of attention by organizations transitioning to the

ture strategic thinking nor detailed analysis and tacti-

new version.

cal thinking is sufficient by itself.

1

Clause 4 introduces some new language and ex-

The standard mandates consideration of internal

pands concepts related to defining requirements. A few

and external issues that affect the ability of the organi-

of the more notable changes include:

zation to achieve its intended results. The requirements

• Understanding the organization and its context.

also say the organization shall monitor and review the

• External and internal issues.

issues it considers to be relevant to its purpose.

• Understanding the needs and expectations of relevant interested parties.

What does it mean?

Subclause 4.1 contains requirements for an organi-

The requirements for understanding an organization

zation to determine external and internal issues that

and its context mean an organization must know itself

can affect and are relevant to its purpose and strategic

and the external organizations and factors that do or

22 QP • www.qualityprogress.com

ISO 9001:2015

can affect it. Achieving such an understanding can result

considered for serious attention. Self-assessments can

from activities such as performance of competitive anal-

be complex, using criteria such as those of the Malcolm

ysis, assessment of existing and emerging technology,

Baldrige National Quality Award, the European Founda-

and evaluation of its impact on the environment.

tion for Quality Management or the ASQ guidelines for

Such activities and assessments are elements of over-

performing a QMS self-assessment.

all strategic and tactical planning for an organization and

Assessment also can be simplified by using the seven

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

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

ing, implementing, maintaining and improving a QMS.

each organization to determine how detailed the analy-

This subject is a normal topic for top managers and is interrelated with subclause 5.1.1 on leadership and commitment,3 which requires top management to ensure a

sis should be and what follow-up action, monitoring and review is needed. External issues can be found through several tech-

quality policy and quality objectives are compatible with

niques such as analysis of:

an organization’s strategic direction and context. This is

• Economic environment and trends.

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

• International trade conditions. • Competitive products and services.

What do I need to do?

• Opportunities and conditions related to outsourcing.

What is meant by “determine external and internal is-

• Technology trends.

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

• Raw material availability and prices.

go?

• Potential changes in statutes and regulations.

One suggested approach is to have a formal process for deciding what to consider and why. This approach makes sense for several reasons:

• Benchmarking best-in-class performers in and outside the current marketplace. Also consider the potential interactions with other

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

processes of your QMS. For example, subclause 4.1 may

2. It precludes going overboard on determining pertinent

have direct or indirect interactions with your processes

external and internal issues. 3. If certification is an organizational objective, it pre-

dealing with interested parties, risks and opportunities, or with clauses 8, 9 and 10.

empts disputes with external auditors regarding

These new requirements related to the organization

compliance. The notes to subclause 4.1 provide guid-

and its context should provide the organization an op-

ance.

portunity to expand the breadth and depth of its QMS,

An organization, for example, could develop a list of

integrate the QMS with the strategic and tactical manage-

areas in which issues could exist and perform periodic

ment of the organization, and align objectives throughout

evaluations of any existing or emerging problems that

the organization.

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

REFERENCES 1. International Organization for Standardization, ISO/FDIS 9001:2015—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 CHALLENGE

Are you a small business trying to navigate the transition to ISO 9001:2015? Read about the unique obstacles small business face in implementing ISO 9001 and the resources available to help in Denise Robitaille’s online sidebar “Resources: The Small Business Challenge,” on this article’s webpage at www.qualityprogress.com.

September 2015 • QP 23

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

ISO 9001:2015 disperses language relating to risk

paradigm shift across all functions. The most prevalent

throughout the standard. The logical segue is that be-

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

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

What does it mean?

similarly expanded to encompass multiple functions

The idea of risk-based thinking isn’t particularly dif-

throughout the organization.

ficult. Whenever an organization decides to change

What happens if you change the design of your most

something or to respond to an impending change, there

popular product? You improve your position in the

are choices, consequences, opportunities and risks.

marketplace and beat the competition. You also incur

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

popular internationally, and it will be helpful in implementing ISO

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

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

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

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

risk nomenclature. How should you understand, implement and

ful for understanding the organization and its context, which

audit to this requirement?

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

Fortunately, you 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

sections 4 and 5 of ISO 31000. These sections explain the how and why of establishing the context. Like ISO 9001, ISO 31000 is more clearly understood after

31000 uses different terms, referring to that standard can help

professional training. Quality professionals who master ISO

organizations implement risk-based thinking in the context of

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

ISO 9001.

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

The writers of ISO 9001:2015 state that “risk-based thinking has always been implicit in ISO 9001”2 and chose not to require

quirements of ISO 9001:2015. Why should your organization embrace risk management as

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

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

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

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

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

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

extensive formal risk management process based on what is

ing how the potential consequences of unknown factors can

appropriate for an organization.

help or hinder your organization’s objectives.

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

This idea is not new. The management of uncertainty is

some minimal risk management be integrated into an organiza-

something you do each day in your personal and professional

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

lives to ensure you achieve your objectives. The requirement

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

that consideration of uncertainty be part of formal and auditable

ceptable degrees in which organizations may choose to manage

processes will serve to further quality and corporate objectives.

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

24 QP • www.qualityprogress.com

—Allen Gluck REFERENCES 1. 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.

ISO 9001:2015

the need to carry inventory of replacement parts be-

ses and implementing sophisticated risk management

cause you’ve made a commitment to your customers

programs—all slick with data, pretty charts and graphs

to continue to support older versions of the product.

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

How about signing a contract that will double your business? You’ll make a ton of money if you can: Get

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

suppliers to ship extra raw material, hire 15 more

To help an organization of any size get over this

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

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

tion schedule to keep your other customers happy.

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

What do I need to do?

To understand your risks, you must understand your

All organizations, but especially small companies,

organization—its internal and external issues, the in-

must apply risk-based thinking in their internal envi-

terested parties that can have an effect on it and its

ronments. A small amount of effort along these lines

ability to fulfill customer expectations.

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

These concepts also can be parsed into smaller

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

components. For smaller organizations, issues can be

When implementing risk-based thinking, parse

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

things out into manageable chunks. The benefit is that

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

you’ll have fewer unpleasant surprises resulting from a

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

failure to adequately assess the risk associated with a

endar affecting parents who need daycare. All of these

change. The change can be as small as substituting an

events carry risks that must be managed properly.

epoxy or as overwhelming as moving the business to a new facility.

There are other changes that must be understood and implemented. All the changes carry some benefit.

One of the side benefits of the inclusion of risk-

The transition process itself carries its own benefit

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

because implicit in the transition is the opportunity to

ineffectual and cumbersome preventive action process

objectively assess a system and sweep away what isn’t

included in ISO 9001:2008.

working.

Often, risk is presumed to be within the purview of large companies with loads of quality technicians and MBAs performing failure mode and effects analy-

REFERENCE 1. 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?

ed issues—with primary top management interaction

The 2015 revision of ISO 9001 contains several impor-

through management review.

tant improvements regarding top management. Specifi-

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

cally, subclause 5.1.1 on leadership and commitment

top management is required to “demonstrate leadership

for the QMS1 includes 11 requirements designed to en-

and commitment” with respect to the QMS by:

sure top management is involved and committed more

1. Taking accountability of the effectiveness of a QMS.

than ever before to the QMS.

2. Ensuring the quality policy and quality objectives

Observers of ISO 9001 throughout the years have

are established for a QMS and that they are compat-

consistently and correctly commented that QMS imple-

ible with the strategic direction and the context of

mentation results suffer without real top management support. As a result, organizations are left to install “bolt-on” quality systems limited to production relat-

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

September 2015 • QP 25

4. Ensuring the integration of the QMS requirements into an organization’s business processes.

If you can clearly imagine the best outcome of each meeting, you can work backward to imagine everything

5. Promoting awareness of the process approach.

you may need to achieve a successful set of results.

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

After all, for many organizations, effective implemen-

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

tation of subclause 5.1.1 will require a fundamental paradigm shift in which top management participates rather than observes. There is, for example, a new requirement to promote

8. Ensuring a QMS achieves its intended results.

awareness of the process approach. No doubt, this may

9. Engaging, directing and supporting persons to con-

become a teachable moment for many organizations,

tribute to the effectiveness of a QMS. 10. Promoting continual improvement.

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

11. Supporting other relevant management roles to

Take your time. Be prepared and professional in

demonstrate leadership as it applies to leaders’ re-

your approach. Develop appropriate action items and

spective areas of responsibility.

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

What does it mean?

status meeting conducted by top management. This

From the perspective of an organization that is already

may be the perfect place to “communicate the impor-

implementing ISO 9001 and looking to transition to the

tance of effective quality management and of conform-

new version of the standard, some will proudly affirm

ing to QMS requirements.”3

the existing link between quality and business goals,

Others requirements in subclause 5.1.1 are also fair

while others face a major realignment of their existing

game for such events, and if you use PowerPoint to

systems.

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

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

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

suring that the quality policy is communicated, un-

still acceptable to use terms to which you’ve become

derstood and applied within the organization,” are

accustomed).

management responsibility-related holdovers from

Naturally, to just proclaim support is not enough,

the 2008 revision. Several additional requirements in

and similarly no one expects top managers to move

the 2015 revision, however, affirm a fundamental shift

into the quality department. The real work will be

from having top management simply provide direction

somewhere in between when it becomes obvious to

and support to its becoming a key participant.

everyone that top management actually is using the

The QMS now must consider how to manage “ensur-

quality system to guide and validate its decisions and

ing the integration of the QMS requirements into the

to encourage the discovery of new areas of improve-

organization’s business processes.” They are now one

ment throughout the organization.

and the same, requiring quality objectives to support the achievement of the organization’s business goals.

Fundamentally, clause 5.1.1 in ISO 9001:2015 is a call for top management involvement in the QMS. “In-

Who better to ensure business success than top

tegration of the QMS requirements into the organiza-

management? After all, top management also is tasked

tion’s business processes” requires analysis and collab-

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

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

ing and supporting persons to contribute to the effec-

together to support common goals, the organization

tiveness of the QMS.”

develops deeper purpose, strength and success.

What do I need to do?

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

That’s the vision you must encourage—the goal you Given the importance of the material, explaining all these changes to top management will best be accomplished through several meetings. It may be constructive to use the second of Stephen R. Covey’s seven habits by “beginning with the end in mind.”2

26 QP • www.qualityprogress.com

REFERENCES 1. 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—Quality management systems—Requirements, see reference 1.

ISO 9001:2015

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

lowing 18 records to be retained:

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

1. Monitoring and measurement of resources (sub-

be the nonexistance of any reference to requirements

clauses 7.1.5.1 and 7.1.5.2, a).

for a quality manual, documented procedures and re-

2. Personnel competency (subclause 7.2, d).

cords to be maintained. Does this mean documented

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

procedures, records and other QMS documents are not

4. Review of requirements related to products and services (subclause 8.2.3.2).

necessary? No, that is not the case. Consider the requirements

5. Design and development inputs (subclause 8.3.3).

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

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

clause requires an organization to maintain document-

7. Design and development output (subclause 8.3.5).

ed information (procedures) to support the operation

8. Design and development change (subclause 8.3.6).

of its processes and to retain documented information

9. Externally provided product and services (sub-

(records) to have confidence that processes were per-

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

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

11. Property belonging to customers or external parties (subclause 8.5.3).

standard to “maintain” documented information (such

12. Control of change (subclause 8.5.6).

as procedures, quality plans and a quality manual) as

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

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

14. Control of nonconforming process output, products

2

How are an organization’s requirements for QMS documents determined? Every organization will be responsible for determining the level of documented

and services (subclause 8.7.2). 15. Monitoring, measurement, analysis and evaluation (subclause 9.1.1).

information, such as procedures, needed to support its

16. Internal audit (subclause 9.2.2).

QMS, processes, product and services.

17. Management review (subclause 9.3.3).

ISO 9001:2015 will specifically require risk-based thinking to be a part of every organization’s process

18. Nonconformity and corrective action (subclause 10.2.2).

approach to quality. Risk-based thinking is not a new activity—it’s a regular part of an organization’s QMS

What does it mean?

and product planning processes, which includes ensur-

Concerning requirements for documented information

ing controls, such as procedures or instructions, are

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

established to address identified risks.

less prescriptive. This increased flexibility will sup-

ISO/FDIS 9001:2015 requires the following docu-

port requirements for documented information to be

mented information to be maintained by every organi-

scaled to be appropriate to the complexity and criti-

zation:

cality of the products produced or services provided.

• Scope of the QMS (subclause 4.3).

The greater the risk or potential consequences of the

• Information needed to support the operation of its

nonconformance, the more control (procedures) re-

processes (subclause 4.4.2, a). • Quality policy (subclause 5.2.2, a). • Quality objectives (subclause 6.2.1). • Control of product and services (subclause 8.5.1). Furthermore, ISO/FDIS 9001:2015 identifies the fol-

quired to address the probability of the risk and its potential impact. Documented information may include procedures, work instructions, drawings, checklists, data sheets, media or records as deemed appropriate for

September 2015 • QP 27

ISO 9001:2015

an organization’s operation.

ISO 9001:2015 will provide an organization in-

Risk-based thinking is essential for identifying risk

creased flexibility to maintain a QMS specific to its

and the resources, such as personnel competencies,

particular processes and product. Risk-based thinking

equipment, facilities, product and services design, ma-

will drive the organization’s need to ensure document-

terials, process procedures and instructions required

ed information, such as procedures, instructions and

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

other QMS documents, are available to address risks

formal risk assessments. The organization will deter-

and opportunities. ISO 9001:2008 certifications will not

mine whether a formal risk assessment is required and

be valid after three years from the publication date of

if so, select a risk assessment method that best suits

ISO 9001:2015.

its needs.

The International Accreditation Forum Informa-

Future QMS audits will require auditors, consul-

tive Document 9: 2015 Transition Planning Guid-

tants and other interested parties to use a different ap-

ance for ISO 9001:20155 provides general guidance to

proach to determining an organization’s conformance

organizations, certification bodies and accreditation

with ISO 9001:2015 requirements. Auditors must be

bodies for preparing to transition from ISO 9001:2008

knowledgeable about the risks associated with the

to ISO 9001:2015.

products, services and processes being audited, and be

Future QMS auditing will need a different approach

able to assess the effectiveness of the controls used to

to determining an organization’s conformance with

manage those risks.

ISO 9001:2015 requirements. Techniques and skills for auditors, consultants and other quality profession-

What do I need to do?

als must change to meet the new challenges of ISO

Consider the following actions to prepare for transi-

9001:2015. QP

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

REFERENCES 1. 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 management—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.

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

28 QP • www.qualityprogress.com

REVISION RESOURCES

ISO 9001:2015 is scheduled to be released later this month and will be available for purchase at asq.org. Find out more about the new standard by: • Tuning in to the ASQ Standards Channel (videos. asq.org/asq-standards-channel) to watch experts discuss changes and transition advice. • Subscribing to the Standards Connection enewsletter at asq.org/standardsconnection to have information delivered to your inbox every month. • Visiting Standards Central at asq.org/standards, where you can find updates, articles and more.

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at Software Quality In 50 Words Or Less

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

1

QP • www.qualityprogress.com

Pilot program uses ISO/IEC 25000 family to evaluate, improve and certify software products by Moisés Rodríguez, Mario Piattini and Carlos Manuel Fernández

SOFTWARE QUALITY

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

September 2015 • QP 31

Software evaluation

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

Activities related to software quality have become in-

versity of Castilla-La Mancha, conducted the evaluation

creasingly important, especially as more organizations

and certification pilot project using the new ISO/IEC

outsource their software functions. This means client

25000 family of standards.

organizations must assess and monitor the quality of the

AQC and AENOR are independent organizations. AQC

products they receive from software development orga-

is responsible for evaluating software product quality,

nizations. In turn, these software development organiza-

thus permitting organizations to meet a quality level and

tions must have the necessary resources to ensure the

improve their software products. AENOR, as an auditing

products developed will meet client expectations.

entity, is responsible for certifying the software product

Despite the proliferation of software quality process certifications (for example, ISO/IEC 15504 Informa-

in cases in which organizations, in addition to improving their products, wish to become certified. Initially, this pilot project mostly focused on the qual-

tion technology—Process assessment and certifications from the Capability Maturity Model Integration Insti-

ity characteristic of maintainability because:

tute), there is little evidence conformance to process

• Maintenance is one of the most expensive phases in

standards actually guarantees good products. In fact,

the software life cycle and, in some cases, can reach up to 60% of costs.

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

• Maintainability is one of the features most frequently requested by software customers. It must be possible

production of mediocre or bad products.2

for customers to evolve software products they ac-

The idea that software evaluations should be based

quire—either by themselves or via a third party.

on direct evidence about a product’s attributes rather than circumstantial evidence about processes used to

• Maintenance work on products with little maintain-

build a product3 is becoming more widespread. An ever-

ability is more likely to introduce new bugs into soft-

increasing number of organizations therefore are con-

ware products.

cerned not only about the quality of the processes, but

The evaluation and certification based on this family

also the quality of the products they develop and acquire.

of standards provides software development organiza-

This is because they may have serious quality problems

tions and organizations that acquire such software a set

after the product has been implanted into their servers.

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

The new ISO/IEC 25000 family of standards, also known as SQuaRE (Software Product Quality Require-

Five activities

ments and Evaluation), appears to meet these needs.

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

ISO/IEC 25000 aims to create a common framework to

Lab using an agile approach,6 responsible for carrying

evaluate software product quality, replacing ISO/IEC

out the software product quality evaluation process. This

9126 and ISO/IEC 14598 and becoming the cornerstone

laboratory performs evaluations by conducting the five

of this area of software engineering.

activities proposed in ISO/IEC 25040:

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

1. Establish evaluation requirements: This activity’s

250404 defines the process of evaluating software prod-

aim is to establish an agreement between the labora-

uct quality, and ISO/IEC 250105 determines the software

tory and client about which purpose and quality re-

product characteristics and subcharacteristics that can

quirements will be considered for the product evalu-

be evaluated (see Figure 2).

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

The Spanish Associa-

will be evaluated are identified, and the rigor of the

Project resolution results / FIGURE 1 39%

43% 18%

and

Certification

(Aso-



The results are an initial version of the evaluation

ciación Española de Nor-

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

Successful

malización y Certificación,

ect’s scope was the complete software products.

Failed

or AENOR), which is a

Although some organizations had defined quality re-

Challenged

member of the Internation-

quirements for their software products (such as low

al Certification Network

complexity or good documentation), a decision was

(IQNet), in collaboration

made to expand them to the requirements associated

Results from 2012 CHAOS research

32 QP • www.qualityprogress.com

evaluation that will be performed is clearly defined.

tion for Standardization

SOFTWARE QUALITY

Software product quality model from ISO/IEC 25010

/ FIGURE 2

Product quality model Functional suitability

Performance efficiency

Compatibility

Usability

Reliability

Appropriateness recognizability Functional completeness Functional correctness Functional appropriateness

Time behavior Resource use Capacity

Learnability

Maturity

Coexistence

Operability

Availability

Interoperability

User-error protection

Fault tolerance

User-interface aesthetics

Recoverability

Security

Maintainability

Portability

Confidentiality

Modularity

Integrity

Reusability

Nonrepudiation

Analyzability

Installability

Accountability

Modifiability

Replaceability

Authenticity

Testability

Adaptability

Accessibility

ably, and the evaluation results are stored in a secure

with the laboratory model.

repository, which can be accessed via a web applica-

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

tion that allows visualization and analysis.

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



The result of this activity is a set of values obtained for all metrics, indicators, subcharacteristics and quality characteristics.

5. Conclude the evaluation: This activity’s purpose is to analyze the results obtained in the previous activ-

The result of this activity is a refined version of the

ity to ensure no errors occurred during the evaluation

evaluation plan with metrics and defined criteria.

and to generate the final evaluation report. This re-

In the pilot project, all the properties of the quality

port is the main output of the evaluation process and

laboratory model (covered later) were selected as the

will be delivered to the customers to allow them to

thresholds established by the laboratory to certify the

review it and, if necessary, express disagreement.

product.

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

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

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

plan the measurement and evaluation activities that

tivity, the laboratory also performs the disposition of the

must be conducted, taking into account the prespeci-

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

fied scope and availability of laboratory resources.

to be maintained (for example, product source codes)

The result of this activity is the final version of the

are removed. This also occurs for confidentiality reasons

evaluation plan, with details of the dates of evaluation

because any data that the client does not wish to remain

activities and the specific resources involved.

in the laboratory after the completed evaluation are re-



In the pilot project, an initial assessment was

turned or eliminated.

planned for each product. This assessment lasted

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

two weeks. Each organization requested a month to

IEC 25000 standards defines models and processes to as-

correct its software products. Finally, the laboratory

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

planned a second evaluation of each product, which

tablish a correlation between the metrics and thresholds

took one week.

needed to identify the specific level of quality a software

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

product has.

to perform measurements on the software product

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

and apply the decision criteria specified in the second

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

activity. Thanks to the automated laboratory environ-

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

ment, this activity can be performed quickly and reli-

ity properties from the software product’s source code.

September 2015 • QP 33

Quality properties

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

The objective of identifying these quality properties was

systems, packages and classes) facilitates develop-

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

ment and maintenance.

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

• Method size—The size of a system directly affects

controversial, based on previous studies and research,

its maintainability because a larger system obviously

and accepted by the scientific community. The main

requires more maintenance. It is considered more ap-

properties are:

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

• Violation of encoding rules—This property is

er level by using, for example, methods that directly

based on encoding rules for each language (such as

evaluate the overall size of the system. This is because

Java code standard) and the percentage of violations.

a change does not usually affect the entire system, but

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

rather a set of elements. • Duplicate code—This property refers to code frag-

• Code documentation—This property refers to com-

ments repeated in different parts of the system. Du-

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

plicate code makes it difficult to modify a software

functionality. Well-documented code helps develop-

application because solving a bug or making an im-

ers understand what it does. Comments also may in-

provement to the code requires changes to all parts of

fluence the ability to reuse software because if you

the system where the duplicate code appears.

know the functionality of a module, you can reuse that module in another system.

• Coupling—This property indicates the degree of interdependence among software units (modules, func-

• Cyclomatic complexity—This property is related to

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

the difficulty involved in implementing, testing, under-

the lower the coupling in a software application, the

standing, maintaining or modifying a program. As this

better its design is considered because low coupling

definition shows, the complexity is related to the fol-

improves maintainability (if there is no coupling,

lowing subcharacteristics: analyzability, modifiability

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

and testability. In applications with high complexity,

creases the reusability of software units.

maintenance tasks require more effort and, therefore, are more costly.

• Cycles—This property refers to the existence of cycles of dependence among the system packages. The

• Structuring—This property refers to dividing the

acyclic dependencies principle states there must be no

system into smaller parts. The quality of the system

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

design is closely related to this property: The correct

istence of cycles in a system has a negative effect on its maintainability because a change that is made to one

Benefits of evaluating software product quality / FIGURE 3

packet affects all the packets in the cycle.7 • Cohesion—This property indicates the degree of relationship between the elements in a module. A class has low cohesion when it performs several unrelated

Software development companies

• Control software product quality.

functions. The functionality provided by its methods

• Improve product characteristics.

thus has little in common with them. The analyzabil-

• Ensure customers receive the appropriate level of quality.

ity, modularity and, in general, maintainability are

• Compare among competitors’ products. • Place the product on the market. • Increase product sales.

negatively affected because these systems are more difficult to understand. They provide features that are unnecessary and changes in requirements that affect several modules.

• Know the quality of the product purchased.

Organizations that acquire software

The evaluation process, the quality model and the

• Compare between alternatives.

properties, along with a measurement environment,

• Establish service-level agreements.

allow a laboratory to evaluate a software product and

• Attain vendor independence.

calculate its quality values. The measurement environ-

• Minimize production failures.

ment automates the evaluations by up to 90% and has

• Reduce the final cost of acquiring software.

34 QP • www.qualityprogress.com

three different levels:

SOFTWARE QUALITY

1. Measuring tools—These constitute the first level. Their mission is to analyze the source code and generate files (usually

Example of evaluation report results / FIGURE 4

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



tained after the software product evaluation in an un-

the organization will obtain a quality evaluation report

derstandable manner.

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

Besides showing the values of quality properties,

organization may choose to become certified (if the

subcharacteristics and characteristics, this environ-

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

ment also allows you to obtain a historical report for multiple versions of a product, compare different prod-

lished quality thresholds. • Step three—When the organization has an evaluated

ucts and even generate predefined reports.

product with an adequate level of quality, it can request

Thanks to this framework, the laboratory has achieved

certification from AENOR by providing its data and the

accreditation as a laboratory for quality software prod-

product to be certified.

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

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

of standards from Entidad Nacional de Acreditación, a

credited laboratory (step four) to check whether the

member of the International Laboratory Accreditation

organization really has evaluated its software product

Cooperation under ISO/IEC 17025.

and the level obtained is adequate for the certification. In this case, the laboratory will provide AENOR with

Six steps to certify products

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

After organizations have evaluated and improved their

continue the certification process.

software products, they can choose to certify these prod-

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

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

fication audit using information from the evaluation

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

laboratory and information obtained after a visit to the

fication and has defined the communication flow, shown

developer. As a result, AENOR creates an audit report

in Figure 5 (p. 36).

with the results and presents the certificate of product

• Step one—If interested organizations wish to certify

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

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

Several assessments and refactoring cycles were

contact an accredited laboratory and request an evalu-

necessary during the pilot project. Three organizations

ation report. At this point, the five evaluation activities

eventually attained quality certifications for their soft-

will begin.

ware products: a document management system, a digi-

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

tal library for mobile platforms and supplier application

September 2015 • QP 35

SOFTWARE QUALITY REFERENCES

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

1. The CHAOS Manifesto: Think Big, Act Small, Standish Group, 2013. 2. Barbara Kitchenham and Shari Lawrence Pfleeger, “Software Quality: The Elusive Target,” IEEE Software, Vol. 20, No. 1, 1996, pp. 12-21. 3. Tom Maibaum and Alan Wassyng, “A Product-Focused Approach to Software Certification,” Computer, Vol. 41, No. 2, 2008, pp. 91-93. 4. International Organization of Standardization (ISO), ISO/IEC 25040 Systems and software engineering—Systems and software quality requirements and evaluation (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.

This pilot project has gained widespread acceptance 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)-certified ISO/IEC 15504 chief auditor and Test management approach (Tmap) Next Certified.

by the participating organizations—those that succeeded 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 development sector can address certification as it relates not only to the quality of the processes, but also to the quality of the software product by using a scheme of international standards such as the ISO/IEC 25000 family. Finally, after this first pilot project, the scope of laboratory evaluations is now being broadened to include new quality characteristics of ISO/IEC 25000, such as

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

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

Flow followed during the pilot software product certification

/ FIGURE 5

1. Request for evaluation of product quality 3. Request for certification

Company interested in software product quality

4. Request for evaluation report

AENOR Asociación Española de

6. Audit results and certificate of product quality

5. Evaluation results

2. Quality evaluation report AENOR = Asociación Española de Normalización y Certificación, or Spanish Association for Standardization and Certification AQC = Alarcos Quality Center

36 QP • www.qualityprogress.com

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 Information Technology Infrastructure Library Foundations.

Example of software product certificate / FIGURE 6

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

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

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

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

TRAINING

CERTIFICATION

CONFERENCES

MEMBERSHIP

PUBLICATIONS

The Global Voice of Quality

TM



Amazing

Audits

Evaluating an audit program’s performance with a standardized approach and the Kano model by Lance B. Coleman Sr. In 50 Words Or Less

• A process and form allows organizations to evaluate the performance of their audit programs. • The evaluation’s score is applied to the Kano model, determining whether the program satisfies the organization’s needs. • The process allows organizations to track their audit programs’ status over time and the effectiveness of implemented improvements.

A QUALITY AUDIT program could be considered a service for an organization that’s provided by the quality department. Because of this, the Kano model can be the ideal lens for analyzing the performance 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

AUDITING

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

September 2015 • QP X39

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

having the best plan in the world is worthless if that plan isn’t properly implemented.

provement and business success. It also can be used as

The ability to support corporate and site goals is

a powerful visual for displaying progress in customer

an often-overlooked segment of an internal audit pro-

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

gram. It also should be seamlessly integrated into a

tion’s ultimate goal—delivering outstanding (delight-

risk management program and play an integral role. The next area of the form addressed reporting and

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

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

provement while the program itself continues to im-

The reporting strategy for audit results was ad-

prove. To know whether you have an excellent audit

dressed to ensure critical and major concerns were im-

program, an assessment must take place, but complet-

mediately reported to the appropriate parties. Safety,

ing a quantifiable, accurate and objective assessment

legal and functional issues are examples of findings

of an internal quality audit program is easier said than

that might be reported to a wider group of managers. The final 30% of the score relates to having adequate

done. I started by creating an evaluation form (see Figure

resources, organizational structure, variability and

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

breadth of the audit program’s impact. Some questions

rated into the Kano model, which provides a needed

that determine whether an audit program has the nec-

framework for evaluating the service of an internal au-

essary resources are:

dit program.

• Are there enough auditors to complete the number of comprehensive audits required within the given

Evaluation forms

timeframe?

The evaluation form assesses critical areas of an audit program, and it weights audit planning as the largest

• Do auditors have the experience, skills and education to evaluate the areas they’re auditing?

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

• Is the required infrastructure—such as office space,

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

computers and supplies—needed to manage the

pects of an organization that must be monitored are

program in place?

consistently reviewed, and the evaluation form awards points for conducting the audits as scheduled. After all,

• Is there a budget for travel if off-site audits are required? • Are there authority and management support to con-

Kano model

duct audits?

/ FIGURE 1

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

Satisfaction

verifying compliance and fulfilling requirements. This

+

gives the program credit for acting on opportunities for improvement (see Table 1). If those opportunities had potential financial savings attached to them, the audit

Delighters

program received additional points.

(excitement factors)

Primary satisfiers

Service not functional

Service fully functional Must-be (basic requirements)

−

Dissatisfaction 40 QP • www.qualityprogress.com

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

AUDITING

findings from the previous year. An organization also should include repeat findings that resulted from an external audit.

Points added for value-add findings / TABLE 1

These points are added or subtracted from the base score (see Tables 1 and 2) using a five-point rating scale: • Five is very good or the best possible. • Four is above average. • Three is minimally acceptable.

Value add Points

Description

+5

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

+2

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

+0.5

• Two needs improvement.

Opportunity for improvement that is implemented by area management.

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

Points deducted based on results of external audits / TABLE 2

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

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.

resources needed to carry out the mandates of their

−1

Each minor finding against audit program from outside audit.

programs. After an organization defines its ratings,

−1

Each repeat finding from previous year.

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

the model should be consistently applied to provide results that can be analyzed and used as input to the continuous improvement program.

After my audit program went through this rating

The audit cycle

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

An audit program manager (APM) develops plans

ing reflected my first impression of the program when

based on organizational, site and audit program goals,

I arrived at the site. The improvements I made during

which include various aspects of compliance, improve-

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

ment and risk management. The APM may receive indi-

my anecdotal and subjective opinion of the program’s

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

status at that time.

pends on an organization’s policy and the experience of the lead auditor. The APM drives the audit’s execution phase by pro-

The evaluation form’s elements were chosen because they’re as objective as possible and likely to be consistent on a yearly basis.

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

Other factors

auditors’ assignments. APMs receive reported audit

Note that there are other important measures of an

results from lead auditors, and they analyze those find-

audit program’s success not included in this model.

ings and report them to site management.

This is because there are factors—beyond how robust

Responses to the audit are included as input in de-

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

velopment of future plans. This entire cycle (see Online

provement: for example, a yearly reduction in custom-

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

er audit findings.

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

Other possible reasons for improvement that are

tum from ongoing revisions of goals and objectives,

unrelated to an audit program’s performance include:

including analysis of data provided by the audit results.

different auditors, stricter clients, improvement in the

September 2015 • QP 41

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

components to meet your organization’s needs, and use

dit only takes a sample after all).

it as an assessment of your assessment program. QP

Even other factors, whether they’re minor or major, can contribute to a reduction of internal audit findings,

REFERENCE 1. Kano Model Tutorial, ASQ.org, http://tinyurl.com/kanomodelasq.

and it’s difficult to consistently quantify monetary savings 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 evaluation tool, and read the sidebar “Case In Point,” which illustrates an example of an audit program before and after improvements were made using this model. You can use the evaluation form in Figure 2 as a guide. Adjust the ratings’ weights and add, change or remove

CASE IN POINT

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

42 QP • www.qualityprogress.com

LANCE B. COLEMAN SR. is a quality engineer and lean program coordinator at The Tech Group in Tempe, AZ. Coleman holds a degree in electrical engineering technology from the Southern Polytechnical University in Marietta, GA. A senior member of ASQ, Coleman is an ASQ-certified quality engineer, Six Sigma Green Belt, quality auditor, biomedical auditor and an Exemplar Global quality management system principal auditor. Coleman is the author of Advanced Quality Auditing: An 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.

Before beginning a root cause and corrective action process 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 address previously cited deficiencies. These changes led to the following results from subsequent customer audits. There were no major audit findings against the quality management system, and there wasn’t any nonconformance 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 substantial, 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

44 QP • www.qualityprogress.com

AUDITING

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

Like Father, Like Son 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 lasting contributions that changed the world of quality. • Both influenced thought leaders and the quality community and helped establish a foundation for Japanese total quality management, as well as quality thinking and methods worldwide.

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

HISTORY

.

.

by Gregory H. Watson

.

.

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

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

After Ichiro Ishikawa graduated from the Imperial

During these pioneering years of JUSE, Ichiro Ishika-

University of Tokyo and served there as an assistant pro-

wa played an important role in convincing senior manag-

fessor in applied chemistry for several years, he joined

ers of major Japanese companies to pursue quality as a

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

top-priority strategy for the reconstruction of Japanese

reer in the Japanese chemical industry, where he even-

industry. In recognition of his lifetime contributions to

tually became an industry leader during the war years

Japan and its industry, Ichiro Ishikawa was decorated

and served as president of Nissan Chemical Industries

with the Grand Cordon of the Order of the Paulownia

and director of the Japanese Association for Chemical

Flowers of the Rising Sun by the emperor. Ichiro Ishikawa’s role as JUSE chairman was not

Industries. Following this period, he transitioned into a cross-

merely an honorary position without real responsibility.

industry leadership role; first as chairman of the Japan

His focus was to convince Japanese business leaders of

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

their responsibility to pursue quality as a key business

president of the Keidanren (Japanese Federation of Eco-

objective for the recovery of Japan’s economy during the

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

postwar reconstruction years. In many ways, he acted as

1948 to 1956.

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

When the Union of Japanese Scientists and Engineers

in Japanese kabuki dramas to facilitate the actions on

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

the stage by the primary actors who are the visible focus

mittee was initially organized with Yoshitomo Tatumi

of the onlookers.

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

My belief in Ichiro Ishikawa’s role has been deduced

intention to maintain a close relationship with industry

through a logical examination of evidence presented

by inviting a recognized leader to serve as its chairman.

through the Deming Prize records.

JUSE top management then invited Ichiro Ishikawa

The effectiveness of Ichiro Ishikawa’s interventions

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

and a measure of his influence has been solidified by the

with Kenichi Koyanagi, the first managing director of

fact that he served as the first chairman of the Deming

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

Prize Committee (established in 1951) and at the first

the initial installation of Ichiro Ishikawa as the founding

Deming Prize Award Ceremony in September 1951. There,

JUSE chairman, JUSE has traditionally requested that

the Deming Application Prize was awarded to four major

the chairman of the Keidanren or JFEO serve concur-

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

rently as its chairman based on this precedent.

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

KAORU ISHIKAWA

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

1939

1947

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

48 QP • www.qualityprogress.com

1960

President, Musashi Institute of Technology (currently Tokyo City University).

1974 1976 1978 1981

Professor, faculty of engineering, University of Tokyo.

Professor emeritus, University of Tokyo. Professor, Tokyo University of Science.

President, International Academy for Quality (IAQ), three-year term.

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

1980

1982

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

1985

Guide to Quality Control (fourth edition), Asian Productivity Organization.

Books published in English



HISTORY

In the following year, eight additional organizations

leaders involved in industry and academia is clear when

received this award: Asahi Chemical Co., Furukawa

examining the list of individual awardees of the Deming

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

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

ogi & Co., Takeda Chemical Industries, Toyo Spinning

search Group, chaired by Shigeru Mizuno, were recog-

Co. and Kyushu Cloth Industry Co.

nized with this award: Tetsuichi Asaka, Kaoru Ishikawa,

During the remainder of Ichiro Ishikawa’s tenure as

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

JUSE chairman, three to four organizations received

ura and Eizo Watanabe. Encouraging these individuals,

this award each year. Many of these recipients came

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

from the chemical industry, and were major Japanese

to dedicate their intellect and energy to developing qual-

organizations that you would expect to be active in the

ity in Japan was an exceptionally important strategy that

Keidanren, or were critical infrastructure industries that

led to efficient management.

were necessary for the reconstruction of a broad-based

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

manufacturing capability for rebuilding the Japanese

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

economy.

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

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

ure of Ichiro Ishikawa to serve in a persuading way to

Deming Prize Award recipients. While no strong conclu-

engage industry and individuals to support Japan’s fledg-

sion can be drawn from this information, it appears that

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

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

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

hind the scenes that caused company executives to pur-

the future, a researcher will search the JUSE archives to

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

determine the validity of this personal belief.

hand guides the benefits to the whole of society based on

Exceptional son

the actions of an individual.1 Another component of Japan’s quality effort was the

I have expressed my deep respect for the contribu-

engagement of top-level executives, which was combined

tions of Kaoru Ishikawa in an earlier article2 in which

with a strategy adopted by JUSE of providing knowledge

I explained how my initial introduction to quality came

and expertise—externally through the lectures by qual-

through the study of his approach to reviewing projects

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

for quality improvement in a series of videos produced

through developing internal experts on quality.

by Hewlett-Packard in the early 1980s.

Evidence of this strategy to get Japanese thought

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

1989

Although I never met him, Kaoru Ishikawa became a

Blue Ribbon Medal of Honor, Japanese government. Eugene L. Grant Award, ASQ.

Walter A. Shewhart Medal, ASQ.

1952 1971 1977 1982 1983

Deming Prize for Individuals, Deming Prize Committee.

Honorary Member, Japanese Society for Quality Control.

Academician Emeritus, IAQ.

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

1986 1987 1988 1990 1993 1994 2007

Honorary member, ASQ.

Order of Sacred Treasure, Gold and Silver Star, Japanese government.

Establishment of the Kaoru Ishikawa Medal, ASQ.

DIED: APRIL 16, 1989

Establishment of the Founders Medal, IAQ.

EDITOR’S NOTE

Honors and awards

For more information about Kaoru Ishikawa’s life compared 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/.

September 2015 • QP 49

virtual mentor to me because I realized how profoundly

systemic effects of quality and its cultural adaptation

he shaped how I formulated my own approach to quality

by focusing on the core components that are universal

consulting. He has greatly advanced the development of

elements and may be applied in any industrial concern

quality by managing its transition across generations and

or cultural context. Kaoru Ishikawa’s professional life was dedicated to

across cultures. Through the development of a collective system of

developing and guiding the fledgling Japanese quality

quality—total quality management (TQM) the Japa-

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

nese way—he demonstrated an appreciation for the

sons learned during its quality journey.

1915

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

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

honoring his legacy.

Edwards Deming Distinguished Service Award for Dissemination

In recognition of this anniversary and to memorialize his lifelong quality career, the Union of Japanese Scientists and Engineers (JUSE) has joined with the Japanese Standards As-

sociation (JSA) and the Overseas Human Resources and Industry Development Association (HIDA) and others in a Birth Centenary Commemoration Project. This project is resolved “to preserve

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

and Promotion of Japanese Total Quality Management (over-

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

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

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

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

teams of Japanese executives and contributed to international

been translated into English by a number of volunteers and is

cooperation in quality control under the sponsorship of various

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

Japanese organizations.

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

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

Tokyo to celebrate the centennial anniversary of his birth.

books and more than 600 papers on various topics related to

The chairman of the executive committee is Noriaki Kano,

quality. —G.H.W.

Kaoru 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 President of the Japanese Society for Quality Control). In addition, many Japanese business leaders and former students of Kaoru Ishikawa are members of the organizing com-

50 QP • www.qualityprogress.com

EDITOR’S NOTE For 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 Research,” Quality Management Journal, July 1994, pp. 86-91. http://asq.org/data/ subscriptions/qmj_open/1994/july/qmjv1i4kondo.pdf. Watson, Gregory H., “The Legacy of Ishikawa,” Quality Progress, April 2004, pp. 54-57, http://asq.org/data/subscriptions/qp/2004/0404/qp0404watson.html.

HISTORY

Furthermore, through his own writings and publica-

faith. In this tradition, each person should leave the

tions and through the research that he encouraged oth-

world a better place as a way of honoring the wisdom

ers to pursue, Kaoru Ishikawa assured that learnings

that has been gathered by ancestors, by passing on and

from Japan would be transferred to the West because

preserving this knowledge for future generations.

the Japanese TQM research and study committees of the

Each person will contribute to the continual cultiva-

1980s translated their final reports into English to share

tion and nurturing of this knowledge to create an ever-

with the rest of the world.

more refined state of being. The responsibility of each of us is to leave the world a better place as a result of

Collaborative leadership

our experience as humans. Perhaps this implicit cultural

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

mindset of Japanese thinking is best described in a guid-

sponsible for all of these results. Early development of

ing precept of Japanese business:

quality in Japan was indeed a collaborative effort. The

“Contribute to developing the welfare of the country

founding generation of Japanese quality thought leaders

by working together, regardless of position, in faithfully

included three men who served as prime movers within

fulfilling your personal duty and show gratitude for the

the early Japanese quality community: Shigeru Mizuno,

contributions of others in things that are both great and

Tetsuichi Asaka and Kaoru Ishikawa.

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

Shigeru Mizuno led the initial Quality Research

ing, the responsibility of each generation is to develop

Group, which interpreted the words of Deming and Ju-

the following generation so that it is capable of fulfill-

ran to help structure a uniquely Japanese approach to

ing its own responsibility and extending the tradition of

companywide quality control.

learning and doing.”

Tetsuichi Asaka served as a consultant and quality

This was accomplished by Kaoru Ishikawa because he

coach who guided Japanese industry leaders and their

was a mentor for a second generation of Japanese qual-

companies in a disciplined approach to quality.

ity thought leaders: Yoshio Kondo, Takanori Yoneyama

Kaoru Ishikawa contributed to the development

and Genichi Taguchi. The current generation of Japanese

of quality methods and shaped the formal structure of

quality thought leaders also have been his disciples, stu-

Japanese quality infrastructure through his leadership in

dents or colleagues. They include Hitoshi Kume, Noriaki

JUSE and development of a national and global structure

Kano, Shoji Shiba and Yoji Akao.

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

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

His achievements in global quality consulting, backed

deep gratitude for your gifts to our current knowledge

by the exceptional performance of Japanese companies

and capability, which would not have been achieved

that were supported by his national quality colleagues,

without your diligent efforts. To paraphrase Isaac New-

created Japan’s strong reputation for quality perfor-

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

mance.

have stood on the shoulders of giants.” QP

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

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

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

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

What is the responsibility of one generation for the next? This question is a focus that is inherent in the Shinto

September 2015 • QP 51

WORLD QUALITY MONTH 2015 November

worldqualitymonth.org

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

Spread the Word

Learn From Others

Raise the global voice of quality!

Join the celebration!

Visit worldqualitymonth.org

MEASURE FOR MEASURE

BY CHRISTOPHER L. GRACHANEN

Where Do You Fit? Updating the U.S. Standard Occupational Classification System MANY READERS may not be familiar

U.S. censuses. This disparity prompted a

used to determine which occupations are

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

partnering of ASQ’s Measurement Qual-

included in the majority of those publica-

dard Occupational Classification (SOC)

ity Division, the National Conference of

tions. One of the major publications used

System. According to its website, the SOC

Standards Laboratories International and

by educators for this purpose is the Oc-

is a:

the Measurement Science Conference to

cupational Outlook Handbook (OOH). The

create a submission for calibration and

following is from the OOH Teachers Guide

… system used by federal statistical agencies

metrology job titles and descriptions to be

webpage:

to classify workers into occupational catego-

added to the 2010 SOC.

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

Unfortunately, SOC administrators ulti-

The Occupational Outlook Handbook (OOH)

mately rejected this submittal on the basis

is an online career guidance resource that

of insufficient substantiation of:

provides information on hundreds of occupa-

1. Unique tasks performed

tions in the United States. Updated every

2. Sufficient population numbers warranting recognition in the SOC. Because the SOC does not contain job

job duties, and in some cases skills, educa-

titles and descriptions for calibration and

tion, and training, are grouped together.1

metrology practitioners, there are

two years by the Bureau of Labor Statistics, the OOH allows students to explore different aspects of occupations by clicking on the following tabs: • What workers do on the job.

essentially no standardized

Discovering disparity

definitions for these oc-

The SOC is updated about every 10 years

cupations. Standard-

(the last update was in 2010), with the

ized occupational

next update slated for 2018. I first became

definitions are used

aware of the SOC in 2002 when I was look-

to homogenize titles

ing for demographic information regarding

and descriptions

the population of calibration and metrolo-

across civil and

gy practitioners in the United States to es-

governmental con-

timate the number of potential candidates

tracts, pay grades

who may elect to become certified if an

scales and position

ASQ calibration and metrology certifica-

qualifications.

tion program existed. The numbers were

It is also important

needed to justify a proposal for creating

to note that to assist

the program. The proposal was eventually

young adults in making

accepted by ASQ’s Board of Directors and

well-informed career

culminated in the creation of the certified

decisions, educators

calibration technician program in 2003.

frequently reference the

After examining the SOC, I learned it

U.S. Department of Labor

does not recognize job titles and de-

publications to provide

scriptions for calibration technicians,

information about oc-

calibration engineers or metrologists,

cupations and forecasts

which means information about these

on future job growth. The

occupations is not being collected via

SOC listing is frequently

September 2015 • QP 53

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

Standard Occupational Classification System search / FIGURE 1

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

Quality Engineer

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

Results for ‘quality engineer’

/ FIGURE 2

and effectively help your students use this valuable tool.2

Many, such as those in the calibration and metrology fields, are faced with large numbers of baby boomers retiring from the workforce along with a critical short-

Results for ‘quality technician’

/ FIGURE 3

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

quality profession, and arguably, this

A query of the SOC website for “quality

warrants a call for action by ASQ leaders

Bigger quality picture

technician” yields two results, shown in

to rectify this disparity. QP

Some readers may be asking what the

Figure 3.

SOC.

SOC position on inclusion of calibration

Furthermore, the alphabetical list of

and metrology job descriptions has to

SOC occupations does not list job titles

do with mainstream quality occupations.

or descriptions for “quality engineer,”

To answer that question, all you need to

“engineer, quality,” “quality technician,”

do is search the SOC website for “quality

and “technician, quality.” You can deduce

engineer,” shown in Figure 1. The search

the implications of this situation on the

MORE ON MEASUREMENT

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

54 QP • www.qualityprogress.com

REFERENCES 1. “Standards Occupational Classification System,” Bureau of Labor Statistics, U.S. Department of Labor, www.bls. gov/soc/home.htm. 2. Bureau of Labor Statistics, U.S. Department of Labor, “Teachers Guide,” Occupational Outlook Handbook, www.bls.gov/ooh/about/teachers-guide.htm.

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

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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-

first time. On this occasion, he was in a

workers. What happened to doing a job

tant for anyone in the quality profession.

hurry and didn’t bother to use fall protec-

right because it’s the right thing to do?

Because the word “quality” is in your job

tion.

What about taking pride in your work? I realized some people never learned

title, people hold your quality of work to a

He ended up accidently stepping on a

higher standard. This is true for big things,

fiberglass skylight and falling 30 feet be-

the importance of a work ethic. I learned

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

fore an upward-facing handle of a butterfly

that lesson early in life—helping my

valve impaled his lower leg. If that valve

brother fix his run-down, old car.

Do you follow up on tasks and track them to completion? Do you proofread

had been mounted just a few inches lower,

emails before hitting send? Do you take the

he’d have died instead of just being injured.

time to really understand the documents

Another time, a worker was dispatched

Setting the example When I was in grade school, my brother

you sign? Do you show up and choose to

to the manufacturing floor to weld a leak-

Craig’s first car was a clunker he borrowed

be present in the meetings you attend? All

ing catch pan. When I went to verify the

from my grandfather. It was 1954 Pontiac

of these things send a message about you

job was complete, I saw a quality of work

that had been rusting in a barn. The deal

as a quality professional, and they either

that wouldn’t have survived the scrutiny of

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

bolster or tarnish your image.

my eighth-grade shop teacher. Besides the

but he had to return it in working condition.

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

hideous, wandering weld bead, there were

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

facturing facility. In its heyday, it was

visible holes in the seam, and the pan was

lousy deal. The transmission was on its

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

still leaking. The workers who’d asked for

last leg, the brakes were going and the car

dilapidated. Upper management was unin-

the repair rightly complained that they still

had countless other problems.

terested in investing in it, and that attitude

had a mess to deal with. Nonetheless, the

was reflected in the crew’s demeanor.

welder had signed off on the work ticket.

One day, a maintenance worker was

Where does this attitude come from?

One evening, I went outside and saw it in the driveway with an extension cord snaking from the garage to the car. The

assigned to repair equipment on the roof.

I understood how demotivating upper

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

He’d been up there many times to fix the

management’s view could be, but these

shifts (one that’s mounted to the steering

same piece of equipment, and you have to

examples of laziness affected the safety

column), and there was an issue with the

wonder why it wasn’t fixed properly the

of the workers themselves and their co-

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 connecting 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 methodically labeled each wire on either side of the cut. Eventually, we gained access to the trouble spot; it took only minutes to

56 QP • www.qualityprogress.com

fix the actual gearshift problem. Daylight faded to full darkness, and the

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

tive example so I can pass the lesson on to

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

a new generation. QP

temperature dropped. Our T-shirts were

ibility it builds. It’s something that should

filthy and we were shivering. I held the

be intrinsic—not just for quality profes-

light as my brother put lengths of heat-

sionals, but for everyone.

shrink tubing on the wires, and painstak-

These same principles apply on the

ingly twisted a wire back together and

home front. Now that I have my own kids,

soldered it. He slid the heat-shrink tubing

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

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

over the joint and shrunk it with a hairdryer. He then slid the cloth insulation over the tubing and held it with electrical tape. Anyone who’s tried holding a soldering gun to a free-floating wire with one hand while feeding solder with the other can understand how this felt like a never-ending chore. I noticed the cuts in the wires were staggered to prevent the bulge created by the repairs from piling up in one spot. As a result, the wire bundle fit back down the steering column and avoided chafing during operation. After the job was done, Craig tested the signals and horn to make sure they worked properly. It was well past 11 p.m. when we finished. I looked up and asked, “Why’d you go through all that? Grandpa doesn’t care about this car. He’s just gonna put it

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September 2015 • QP 57

CAREER CORNER

BY ROSEMARIE CHRISTOPHER AND PAUL DIONNE

Truth Detective Tips for investigating prospective employers, avoiding duds WHEN YOU’RE SEARCHING for a job,

truly valued integrity. CEO intervention

advanced search feature and select the

you don’t want to end up working for

will be required to improve ethical deci-

“past company” category to find people

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

sion making, and don’t delude yourself

who previously worked at the organiza-

by believing you would be immune.

tion. View each profile to get a sense of

unemployment situation has improved, and the tables are turning back in favor

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

of employees. Even people who’ve ex-

ing a job if you’re not going to receive

employers, use the location, title or other

perienced long-term unemployment are

the resources you need to accomplish

criteria to narrow your search to a par-

re-engaging in their job hunts.

anything meaningful. Research the orga-

ticular department. Good signs include

nization’s finances and look for signs of

long stays, promotions and people who

tions as part of employee recruitment

poor pay or a lack of funds. A CFO or

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

and retention. Here are four potential

CEO might be able to reverse the situa-

you see a high number of people who

tion, but few others can.

worked there less than a year.

Employers must consider their reputa-

problems you should investigate at any organization that’s offering you a second-

• Bad culture—Symptoms of a bad cul-

how long they stayed there. For large

Interview past employees. You can

round interview:

ture appear in many forms. It’s possible

send messages to previous employees via

• High turnover—This can be the result

that people are too busy creating fief-

LinkedIn’s InMail feature, and ask about

of multiple issues. A strong HR leader

doms that inhibit change, or everyone’s

their experience at the organization.

might be able to fix a turnover problem

input is required, creating meeting after

There’s a pretty low chance of getting a

but only with sustained support of the

meeting and preventing anything from

response. Few people want to badmouth

CEO.

being accomplished. Poor ethics and fi-

a previous employer, and you can assume

nances may contribute to a bad culture,

a lack of response means the organiza-

organization’s leadership will trickle

too. It can cause employees to blame

tion is below average. On the other hand,

down. If you see poor ethical decisions

others for their problems rather than

if you hear back from someone, you may

being made, they’re likely happening

rolling up their sleeves and collaborat-

receive make-or-break information you

throughout the organization. Lower-

ing to reverse the bad situation. Unless

couldn’t get elsewhere.

level employees practicing unethical

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

behaviors would be fired if their leaders

bad culture.

• Poor ethics—The ethics of an

Check out the organization on Google Finance or Yahoo Finance. If you don’t know how to read corporate financials,

Uncovering the issues

ask someone who does—having an

Use LinkedIn to see

organization experiences financial highs

how long people stay

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

there. When recruiters

understand why they’re in that situation

look at résumés and

and what it would take to change it.

see a string of short

Read employee review sites such

employment stints, they

as Glassdoor and Indeed. Again, most

assume the person is

people will avoid badmouthing a previ-

a job hopper. LinkedIn

ous employer. When someone does, you

gives us the power to

should take note, but read the reviews

turn the tables and

carefully. They may have been faked or

understand an organiza-

embellished. Some HR departments have

tion’s turnover rate.

been known to post favorable reviews

Use LinkedIn’s

58 QP • www.qualityprogress.com

outsider’s perspective can help. Every

of their organizations. Although they

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

regulators—such as the Federal Avia-

If you’re a CEO, CFO or board mem-

Conflicting reviews also may reflect that

tion Administration, National Oceanic

ber, investigate your organization. As the

some employees had good bosses and

and Atmospheric Administration, or

game of talent acquisition heats up, you

others didn’t.

U.S. Securities and Exchange Commis-

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

Read customer review sites such as

sion. Our organization provides staffing

Yelp, Google and the Better Business Bu-

for U.S. Food and Drug Administration

reau (BBB). On these sites, customers air

(FDA)-regulated businesses. We check

their complaints and report issues with

prospective partners for warning letters

an organization’s products or services.

and recalls on the FDA’s website (or

Picture yourself working at that organiza-

U.S. Department of Agriculture for food

tion, and distinguish between complaints

recalls).

you would be in a position to address

Some organizations will view a recall

versus ones that would be out of your

or warning letter as a call for improve-

control. When the BBB receives com-

ment, which is good. Others will see it as

plaints, it contacts the chief executives at

“government overreach” that they must

each organization. On the BBB site, if you

comply with, which is bad. We do not

see a slew of issues that weren’t resolved

recommend directly raising an issue in

to the customer’s satisfaction, there’s a

an interview. Instead, ask questions that

problem at the top of the organization.

will uncover whether the organization is

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

REFERENCE 1. “Employment Situation Summary,” Bureau of Labor Statis- tics economic news release, http://tinyurl.com/t68g.

ROSEMARIE CHRISTOPHER is an organizational communications consultant and the president and CEO of MEIRxRS, a family of science, technology, engineering and math recruitment and staffing organizations in Glendale, CA. She has a 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.

handling its current situation, and how it’s going about it.

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September 2015 • QP 59

STATISTICS ROUNDTABLE

BY CONNIE M. BORROR

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

millimeters. Thirty flakes were toasted,

in a designed experiment when it should

simple experiment—such as one with

measured at five locations, and the aver-

be included, you could obtain erroneous

a single factor with several levels—sig-

age of all 150 thicknesses was used as the

conclusions about the factor of interest. In

nificant care and consideration should

response. The factor of interest is toast-

addition, if the blocking factor was used

go into the design setup. It is rare for

ing time, and four times are considered

in the experiment, but the wrong analy-

the response of interest to be influenced

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

sis carried out, you also could reach the

only by one factor under study during the actual experimentation. There could be a number of other

Three replicates for each toasting time were obtained while randomizing

wrong conclusion about the factor of interest. Let’s look at the latter a little closer.

the times. You want to know whether

factors affecting the response if not

toasting time has a significant effect on

ANOVA activities

controlled or included in the experi-

flake thickness. In other words, is there a

Given the designed experiment discussed

ment. Those factors that are not the main

statistically significant difference among

earlier—with four toasting times and

factors of interest but could influence

the toasting times?

three ovens—a total of 12 average thick-

the response are often referred to as nui-

nesses were obtained, as shown in Table

sance factors. If the nuisance factor can

1. An analysis of variance (ANOVA) was

be controlled during experimentation, it

carried out for the experiment, and the

is often included in the design setup as a

results are listed in Table 2. In this experi-

blocking factor.

ment:

If there is only one nuisance factor

• The factor of interest is toasting time.

with several levels, you try to carry out a

The goal is to determine whether there

randomized block design—given the main

is a statistically significant difference

factor (factor of interest) can be random-

among the four times. A final goal may

ized within each level of the blocking

be to determine the optimal or best

factor. If there is more than one nuisance

toasting time.

factor, you may be able to include them in

• The oven is a blocking factor because

the design setup as well as using designs,

you think different ovens may influ-

such as the Latin square design. In this

ence the results, but it is not a main

article, the importance of blocking using

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

one main factor (with four levels) and

ested in picking the optimal oven. You

one nuisance factor (with three levels)

will not determine which oven gives

will be illustrated.

the best results and only use that oven In this experiment, there were three

and discard the other two.

Corn flakes and ovens

ovens that could be used for toasting,

Suppose you’re interested in the thick-

so toasting time could be randomized

which provides evidence there is a

ness of corn flakes after they have been

within each oven. Because ovens may

statistically significant difference among

toasted. Toasting is just one of the

operate differently and possibly affect the

the four toasting times. Toasting time

processing steps of corn flakes for cere-

flake thickness, ovens were treated as a

appears to have a significant effect on

als and can cause several changes in the

blocking factor in the experiment. There

the average corn flake thickness. Some

corn flakes, which in turn could affect the

were other possible nuisance factors at

statistical software packages will report a

consumer’s view of the cereal.

play, but they were held constant for the

p-value for the blocking factor as well. As

purpose of the experiment.

stated earlier, however, you’re not always

1

“Puffiness” or thickness is one response of interest and is measured in

60 QP • www.qualityprogress.com

If you don’t include the blocking factor

The p-value for toasting time is 0.031,

interested in statistical significance of the

Average corn flake thickness / TABLE 1 Oven Time

1

2

3

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

6.02

0.031

 2

1.145

0.5725 0.0858

20

1.6

0.6

0.7

Oven

40

1.7

1.6

0.8

Error

 6

0.515

60

2

1.2

1.6

Total

11

3.210

80

1

0.7

0.3

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

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

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

DF

SS

MS

F

P-value

Toasting time

 3

1.550

0.5167

2.49

0.134

The correct analysis

Error

 8

1.660

0.2075

Now, carefully consider the importance

Total

11

3.210

cluded in the experiment in the first place.

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

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

block), but the results are incorrectly I like to think of the error as a trash

experiment involved ovens, which was the

ovens. Table 3 provides the ANOVA for

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

appropriate design, but the wrong analysis

this situation.

not be assigned to some other factor or

carried out.

analyzed without the blocking factor:

Now, notice that toasting time is not

interactions involved in the experiment.

Any time you can include a blocking

statistically significant with a p-value

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

factor or other factors in the experiment

of 0.134. That is, toasting time does not

it could be parsed into df and SS for other

itself, you should. The next step is to

significantly affect flake thickness. What

factors. That is, when you can identify a

make sure to carry out the experiment as

happened? The degrees of freedom (df),

source of variation, the df and SS can be

planned, and if any deviation is encoun-

sums of squares (SS) and mean square

partitioned into that source (or sources if

tered, it should be recorded and reported.

(MS) for toasting time are identical to the

more than one), and you have a better idea

The type of analysis depends on the actual

previous analysis, but the F value and, of

of what role factors play in an experiment.

experiment conducted. QP

course, p-value differ. These values are not

Because in this case, the error mean

influenced by the addition or omission of

square increased, the overall F value for

other factors (such as ovens).

toasting time decreased (and resulting

The error has changed, however, and

p-value increased)—giving the wrong

it is the mean square for error that is used

result that toasting time is not statistically

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

significant. This is the wrong conclusion

toasting time. The error quantities now

because you know the origin of some

include all of the values once represented

of the error quantities: the ovens, which

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

for some reason did not get included in

just disappear, but get lumped in with the

the analysis (I have seen this happen in

remaining “error.”

practice on more than one occasion). The

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

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

September 2015 • QP 61

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September 2015 • QP 63

Special Advertising Section

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September 2015 • QP 67

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

most commonly used quality tools.

dedicated to customer-supplier relation-

the analysis and math, the author guides

Russell T. Westcott and Grace L. Duffy, ASQ

ships. There is also a nice discussion

the reader from basic systems up to large,

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

about the process of supply chains, which

complex and multistate systems and uses

$105 list (third edition, book).

includes key supply chain metrics. The

a consistent set of examples based on an

This book serves

last unit on system integration discusses

iterative approach.

as a valuable

the view of the organization as a system

source of informa-

and distinguishes the process view from

large hierarchal systems, and there is a

tion pertaining to

the systems view. It emphasizes taking a

chapter on process modeling. In discuss-

quality concepts,

systems view of quality improvement.

ing large, complex systems, the author

quality improve-

We live in an era of outsourcing and offshoring. Recognizing this, there is a unit

This book is written in simple and

system breakdowns and variations of system arrangements and performance. Easy to read but challenging in terms of

Other systems are discussed, such as

uses the asymptotic approach along with

ment and continu-

easy-to-understand language such that

ous improvement.

readers with little or no knowledge of

The information

quality concepts can understand and apply

of mathematics and research built around

is presented in

quality tools with confidence. This book will

a logical but comprehensive bibliogra-

five units, each dedicated to an important

serve as a valuable reference for everyone

phy. Elsevier specializes in technical and

aspect of quality improvement. The book

involved in the quality engineering and

leading-edge books, and this is representa-

begins with detailed explanations of the

quality management industry.

tive of that high standard. Please note that

key concepts and definitions pertaining to

Rangarajan Parthasarathy

quality, and then discusses the benefits of

Harvard, IL

quality improvement and employee involvement in quality improvement efforts. There is a chapter dedicated to the phi-

several examples. The book is a highly detailed assemblage

while this is a truly challenging topic it is also logical, highly polished and thoroughly researched.

Reliability of Large and Complex Systems

losophies of the quality gurus. This chapter

Krzysztof Kolowrocki, Elsevier Insights,

contains valuable information regarding

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

Frank Pokrop San Diego

the way the quality leaders viewed quality

The book assumes

and continuous improvement, and it also

readers are famil-

presents their contributions to the quality

iar with a number

How to Succeed With Continuous Improvement: A Primer for Becoming the Best in the World

movement.

of underlying prin-

Joakim Ahlström, McGraw-Hill Education,

ciples of concepts

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

is the key to the success of any quality

Recognizing that employee involvement

such as reliability,

Big efforts often fail because no one feels

improvement project, the book’s second

calculus and how

responsible for major changes. That’s why

unit has two chapters dedicated to under-

to devise formulas

the most successful companies focus on

standing how employees work in teams,

that represent

improving the small things, which together

and the key issues involved in team forma-

multifaceted

add up to major paybacks. While this book

tion and group dynamics. The third unit is

mechanical and

is comprehensive and easy to read, it does

devoted to the tools and techniques used

electrical systems. It is clearly aimed at the

in continuous improvement and process

more experienced reader and dives into

improvement projects. There are elaborate

the world of complex systems, higher-level

ous improvement. The method of problem

explanations with suitable examples for the

math, and a continuous series of analysis,

solving and achieving improvement is not

68 QP • www.qualityprogress.com

not focus on a specific industry or sector. Simply solving a problem is continu-

important. This book discusses the FISHY method for problem solving and provides

limitations and breaking points.

ples from the author’s extensive work and

The book is broken into four sections

research to demonstrate application. The

many examples. The FISHY method entails:

building from an understanding of risk;

book also includes exercises and questions

1. Formulate the question.

to simple Monte Carlo simulations in MS

making it an excellent resource in an edu-

2. Individual work.

Excel; to applica-

cational environment. A glossary of terms,

3. Spread out the notes.

tions in fixed income

an index and reference material make this

4. Have consensus through voting.

and commodities; to

a good starting point for self-education.

5. Your to-do list is introduced.

a review of the prod-

The focus of this book is the corporate

The book includes success factors for

uct universe driving

risk-management professional. However,

improvement work and practical advice on

risk. The risk section

any person interested in using models to

how to start and

focuses on com-

better understand and manage risk—par-

maintain momen-

plexity of analysis

ticularly in the financial arena—will find this

tum. It features

versus complexity of

book interesting.

a questionnaire

models, dealing with

for determining

volatility, target accounts for managing risk

the current state

along with risk policy and risk regulation.

of a problem, a

The Monte Carlo simulation section de-

Bryan Ruggles Everett, WA

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reference guide

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fishbone diagrams

the effect of changes in prices on business

in 15 minutes and

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Configuration Management For Senior Managers

and commodities section includes applica-

Frank B. Watts, Butterworth Heinemann,

tion examples that focus on identification

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

an additional reading list. When you do not take time to make improvement, you do not get better. Every

of relationships, drivers and data across

business will gain from following the

commodity markets. Finally, the last section

author’s well-considered methods and

provides a broad review of the product

Quality Management in a Lean Health Care Environment

recommendations.

universe, pricing and valuation models.

Daniel Collins and Melissa Mannon,

Marc A. Feldman Houston

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

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RESEARCH

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

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ONE GOOD IDEA

BY UMESH KRISHNAPPA

See the Full Spectrum Monitoring the effectiveness of corrective actions TO ELIMINATE FAULTS from reap-

equacy are highly repetitive in nature (see

pearing, fault data spectrum (FDS) is a

Online Figure 1, found on this column’s

The FDS grid (see Table 1) contains

tool that can monitor the effectiveness

webpage at www.qualityprogress.com).

fault codes and product serial numbers

Faults are not created equal. The im-

of corrective actions (CA) on a continu-

and a positrol grid.

or production batch numbers. In each

ous basis. An FDS visually displays the

pact of a few could have catastrophic ef-

column, it color codes the implementa-

effectiveness of your CAs. If faults still

fects on the product, such as safety faults.

tion of CAs with reference to the affected

occur after CAs are implemented, your

Other types may occur in large numbers

product serial numbers. After the imple-

organization will catch them early enough

and not be noticed by customers and only

mentation of CAs, the faults should taper

to regroup the CA teams for additional

by highly critical inspectors. These faults

off drastically or disappear.

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

don’t have any affect on functionality or

conduct proper root cause analyses and to

reliability and could be resolved through

was taken after product 226, but the ac-

create fully effective CAs.

simple changes to a process or material.

tion was only partially effective and didn’t

This is why faults need classifications.

A fault can occur in a process or

For faults F1 and F2, for example, a CA

completely eliminate complaints. After

product component if its parameters

Acceptance quality levels (AQL) can be

another PDCA cycle occurred at product

deviate beyond the permissible limits of

decided for different categories of faults

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

its designed intent. A process fault could

based on the criticality of the product.

ucts sold.

happen due to high dispersion and can be

Critical healthcare equipment, for ex-

controlled by the process and machine

ample, will have a rigid AQL. Faults are classified, coded and later

parameters. Process faults ultimately lead to faulty products. A fault also may result if the desired output is not achieved with the intended

tured—a costly lapse for the organization.

and the fault codes are created during

Faults three, four, five, seven and eight

development stages.

showed CAs that were done right the first

FDS of a subsystem with fault codes and factual data for up to 3,000 units sold / TABLE 1 80

Fault data spectrum for XXXX assembly 13 5 6 3

41 476–3,000 401–475 376–400 351–375 326–350 301–325 276–300 251–275 226–250 201–225 176–200 151–175 126–150 101–125 76–100 51–75 26–50 0–25

Production batch Total Fault types

5

4

1 1

1 1 1 6 4 7 2 13

1 3 1

1

1

1

1

1

1

1 2 2 1 1 1

5

1 2 1 1

2 2 1 1 1

1 1 2

xxxx not opening with zzzz

Final effective solution

xx/yy not opening from inside

xx/yy not opening from outside

Interim action— not fully effective

xxxx noise (abcd loose)

nnnn failures

a positrol sheet shown in Online Table 2.

short and effec-

For additional examples of FDS and posi-

tive. If it isn’t, it

trol grids that were used on a manufactur-

will require anoth-

ing process for a hair dryer with five major

er cycle and cause

faults, see Online Tables 3 and 4. FDS and fault classification are linked

cause of customer

and able to take actions upstream at tier

dissatisfaction

one, two and three supplier levels. They

is repeated inef-

can be used during development phases,

fective CAs (see

and each failure that’s encountered in

Online Figure 2).

alpha, beta or pilot production is made

FDS is a tool consisting of fault

visible for an easier and more effective resolution. QP

classifications with a positive

1

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

time, and the actions were described in

cycle should be

delays. A main 3

1 1

was equivalent to 100 products manufac-

traced in the field (see Online Table 1),

A PDCA cycle is used for CAs, and the

design input. Faults due to design inad-

The additional PDCA cycle did, however, consume production time that

xxxx switch failure

Containment action

White dot mark

control plan (also called a positrol) in a grid structure. The tool

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

uses an FDS grid

FDS = fault data spectrum

September 2015 • QP 71

BACK TO BASICS

BY RICK TOWNSLEY

Just Do It Quality organizations don’t always need certifications SOME ORGANIZATIONS with certifi-

How do these organizations become

Service with a cookie

cations from the International Organiza-

so successful? They listen, respond,

I’ve gone to the local eye institute for

tion for Standardization (ISO) do not

improve and start over again. They

several years. When I step inside, friendly

deliver high-quality products, and yet,

stay current with customers’ needs and

people are ready to help me at the front

organizations without these certifica-

expectations, study their competition

desk. The atmosphere is pleasant, and

tions sometimes provide amazing levels

and replicate best practices, and adapt to

there are color-coordinated walls, carpet-

of quality. Why is that?

changing conditions. In other words: they

ing and seating arrangements showing me

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

where to find my doctor.

The goal of any organization is to provide excellent quality products and

Whether the PDCA cycle is known to

The service is fast, and everyone has

services to its customers to earn their

an organization or not, it’s often intui-

a clearly defined job. Free coffee and

loyalty and repeat business. It’s tradi-

tively implemented by smart, enterprising

tea are available at strategically located

tionally understood that organizations

people who know how to succeed without

stations, and there’s even a staff member

possessing ISO certifications are the

all the charts, graphs and documented

who walks around with a tray of warm

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

management reviews. Instead of getting

cookies. “Have a cookie please,” she

the case, and sometimes even the op-

caught up on collecting paper (known as

says. “They’re delicious.”

posite is true.

objective evidence to quality auditors),

Another staffer engages and consoles

they just do it. There are two real-world

some of the older patients. For patients

the importance of these certifications,

examples I frequently encounter that

who need assistance, a courtesy van

but you also should consider that some

illustrate organizations just doing it, not

waits outside to take them home.

organizations don’t subscribe to these

overdoing it.

It would be a mistake to discount

standards, and their customers’ ratings

Great customer service is just one piece of the quality puzzle, but many

show they’re superior to their certified

Consistent satisfaction

elements of the ISO 9001 standard are

counterparts. This is because they un-

When I visit Mike’s Deli near my office,

represented in these examples, such as:

derstand what it takes to be successful

there’s usually a line of customers in front

execution to management responsibility,

without all of the policies, procedures,

of the building before it opens. When the

customer focus, planning, provision of

work instructions and reams of docu-

doors open, people flock inside.

resources, infrastructure, consideration

mentation.

One person takes your order and gives you a number, and another person works the cash register.

of work environment, product realization and data analysis. Don’t get caught up on quality certi-

You get a beverage at the drink

fications alone, and look deeper into an

station and sit down while your

organization as a whole. Everyone can

food is prepared. Within minutes,

learn from everybody whether they hold

your number is called, and you’re

certifications—or not. QP

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

72 QP • www.qualityprogress.com

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

ISO/FDIS 9000:2015 and ISO/FDIS 9001:2015 The revised ISO 9001 standard will be published in fall 2015. But, don’t wait to get a jumpstart on your training, auditing, and more to become certified to the new standard! The ISO/FDIS 9000:2015 and ISO/FDIS 9001:2015 are now available for purchase! To get started, and to learn more, visit asq.org/aboutstandards.

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

asq.org/standardsconnection

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