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www

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July

2014

The Global Voice of Quality

TM TM

Putting Best Practices to Work

U U A A L L I I T T Y Y P P R R O O G G R R E E S S S S | | _J_J U U L L Y Y 2 2 0 0 1 1 4 4 T T H H E E C C A A R R E E E E R R I I S S S S U U E E V V O O L L U U M M E E 4 4 7 7 / / N N U U M M B B E E R R 7 7

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Reasons to Read

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Network

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Cultivate career prospects with

these simple tips

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A new approach to

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Check out a few of the NEW books

from

ASQ Qual

ity

Press!

The Certified Pharmaceutical GMP The Certified Pharmaceutical GMP Professional Handbook

Professional Handbook

The purpose of this handbook is to highlight and The purpose of this handbook is to highlight and partially annotate what the founders of the Certified partially annotate what the founders of the Certified Pharmaceutical Good Manufacturing Practices Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination believed to be the Professional (CPGP) examination believed to be the main topics comprising worldwide pharmaceutical main topics comprising worldwide pharmaceutical good manufacturing practices (GMPs).

good manufacturing practices (GMPs). Item: H1386

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Continuous Permanent Improvement Continuous Permanent Improvement

The purpose of this book is not to expound any The purpose of this book is not to expound any new theory or tools, but to share experiences in new theory or tools, but to share experiences in implementing existing methods with a bias toward implementing existing methods with a bias toward business results. In fact, one of the important business results. In fact, one of the important lessons we have learned is that most existing lessons we have learned is that most existing models or methods, if adhered to in the right spirit, models or methods, if adhered to in the right spirit, will give results.

will give results. Item: H1466 Item: H1466

The Certified HACCP Auditor Handbook, The Certified HACCP Auditor Handbook, Third Edition

Third Edition

This handbook is intended to serve as a baseline This handbook is intended to serve as a baseline of hazard analysis critical control point (HACCP) of hazard analysis critical control point (HACCP) knowledge for quality auditors and assists the knowledge for quality auditors and assists the certification candidate preparing for the ASQ certification candidate preparing for the ASQ Certified HACCP Auditor

Certified HACCP Auditor (CHA) examination.(CHA) examination. Item: H1449

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The Biomedical Quality Auditor Handbook, The Biomedical Quality Auditor Handbook, Second Edition

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In addition to being a peerless reference for ASQ’s In addition to being a peerless reference for ASQ’s Biomedical Auditor certificat

Biomedical Auditor certification (CBA), this ion (CBA), this book isbook is a valuable reference for biomedical professionals a valuable reference for biomedical professionals who want to execute better audits for medical who want to execute better audits for medical devices and gain basic knowledge of biomedical devices and gain basic knowledge of biomedical technical areas and regulatory requirements. technical areas and regulatory requirements. Item: H1423

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FEATURES

• Google+ Hangout

Follow a link to watch a live

Google+ Hangout with some of

the bloggers featured in “Blog

Boom,” pp. 16-23. The bloggers

will discuss the value of social

media to quality professionals

and how to get involved. The live

event takes place at 12 p.m. CST

on July 23. You also can watch

a recording of the discussion later.

• Innovation Insight

Three sidebars with more career

advice from Peter Merrill, author

of this month’s Innovation Imperative

column, “Making Choices,” pp. 39-40.

• SIPOC Supplement

A suppliers, inputs, process,

outputs and customers diagram

to illustrate progress on the AS9100

revision, the topic of this month’s

Standards Outlook column, “Revision

Runway,” pp. 50-52.

• Free Template

See an example of an individual

development plan—a quality

tool used to improve skills and

performance—that accompanies

this month’s One Good Idea

www.qualityprogress.com

ONLY

@

SOCIAL MEDIA

Blog Boom

The backstory on blogging from ﬁve quality professionals who use the popular medium to learn, create, connect and share.

by Jimena Calfa, Mark Graban, John Hunter, Jennifer J. Stepniowski and Dan Zrymiak

CAREERS

Making Connections

Advice on building a network of professional connections—including ways to perfect your LinkedIn proﬁle—to get the career you want. by Marshall Brown

PROCESS CAPABILITY

First Things First

Before spending precious time and resources establishing process control, determine whether the process can meet customer requirements in the ﬁrst place.

by C. Steven Arendall, Andrew A. Tiger and Kevin W. Westbrook METROLOGY

Necessary Measures

Understand the difference between standard and expanded gage repeatability and reproducibility studies and how the latter helps clarify measurement system variation.

by Louis Johnson and Maureen Deaner

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QP • www.qualityprogress.com 4

LogOn

• Supplier or customer?

Expert Answers

• Building an effective QMS. • Understanding medians.

Keeping Current

• Concerns with the VA healthcare system.

• Report to president touts Baldrige.

Mr. Pareto Head

QP Toolbox

QP Reviews

DEPARTMENTS

Up Front

Social cues.

Innovation Imperative

Recognizing good career opportunities.

Statistics Roundtable

Caution when categorizing quantitative variables.

Measure for Measure

Understanding test accuracy and uncertainty ratios.

Quality in the First Person

Back to the beginning.

Career Corner

What career centers can do for you.

Standards Outlook

Updating AS9100 standards.

One Good Idea

The beneﬁts of individual development plans. Mail Quality Progress/ASQ 600 N. Plankinton Ave. Milwaukee, WI 53203 Telephone Fax 800-248-1946 414-272-1734 414-272-8575 Email

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

Article Submissions

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

Author Guidelines

To learn more about the manuscript review process, helpful hints before submitting a manuscript and QP’s 2014 editorial planner, click on “Author Guidelines” at www. qualityprogress.com under “Tools and Resources.“

Photocopying Authorization

Authorization to photocopy items for internal or personal use or the internal or personal use of speciﬁc clients is granted by

Quality Progress provided the fee of $1 per copy is paid to ASQ or the Copyright Clear-ance Center, 222 Rosewood Drive, Danvers, MA 01923, 978-750-8400. Copying for other purposes requires the express permission ofQuality 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

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, 800-521-0600 x2888, international 734-761-4700, www.il.proquest.com.

Membership and Subscriptions

For more than 60 years, ASQ has been the worldwide provider of information and learning opportunities related to quality. In addition, ASQ membership offers information, networking, certiﬁcation and educational opportunities to help quality professionals obtain practical solutions to the many problems they face each day. Subscriptions toQuality Progress are one of the many be neﬁts of ASQ membersh ip. To join, call 800-248-1 946 or see infor mation

and an application on p. 2.

List Rentals

Orders for ASQ’s member and nonmember buyer lists can be purchased by contacting Michael Costantino at the Infogroup/Edith Roman List Management Co., 402-836-6626 or fax 845-620-1885.

COLUMNS

QUALITY PROGRESS

Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203. Editorial and advertising offices: 414-272-8575. Periodicals postage paid at Milwaukee, WI, and at additional mailing offices. Institutional subscriptions are held in the name of a company, corporation, government agency or library. Requests for back issues must be prepaid and are based on availability: ASQ members $17 per copy; nonmembers $25 per copy. Canadian GST #128717618, Canadian Publications Mail Agreement #40030175. Canada Post: Return undeliverables to 2835 Kew Drive, Windsor, ON N8T 3B7. Prices are subject to change without prior notification. © 2014 by ASQ. No claim for missing issues will be accepted after three months following the month of publication of the issue for domestic addresses and six months for Canadian and international addresses.

Postmaster: Please send address changes to the American Society for Quality, PO Box 3005, Milwaukee, WI 53201-3005. Printed in USA.

ASQ’s Vision:

By making quality a global priority, an organizational imperative and

a personal ethic, the American Society for Quality becomes the community for everyone

who seeks quality technology, concepts or tools to improve themselves and their world.

- EYE ON IMPROVEMENT

An IT organization strives to build a

self-sustaining business excellence culture.

- QUALITY-DRIVEN CULTURES

Report on what organizations view as the vital components to a true culture of quality.

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UPFRONT

Social Cues

Be true, be you; get it right in social media

IT USED TO BE_{that you only had one reputation to uphold. Social media has turned}

that concept on its ear. Now, it’s prudent to be conscious of your reputation on the inter-net, because the medium and its contents can be that much more far-reaching. To some, this age of increased visibility and the availability of what some consider to be private or at least protected information is alarmi ng.

Yet, the wide net the digita l age casts can be a beautiful thing, par ticularly when it comes to growing personal a nd professional networks, opening up career prospects and getting your name in front of the rig ht people—job recruiters or hir ing managers, for instance.

Often, people join or are a part of a professional association to help further their careers. Whether it’s seeking cert iﬁcation or trai ning, or accessing knowledge resources, career advancement is a perennial interest area for readers. This month’s issue is

dedicated to that pursuit.

In “Making Connections,” p. 24, author Marsha ll Brown has pulled together a handy list to help you improve your networking skills and land the job you want. He d iscusses how to maximize opportunities at live events and in the virt ual world. He also has a help-ful sidebar on making the most of your LinkedIn proﬁle.

“Blog Boom,” p. 16, showcases this popular medium and introduces you to some ac-tive and engaging bloggers in the qua lity community. Whether you just want some fresh reading mater ial, or you’re interested in the possibility of blogging yourself, you’ll ﬁnd these bloggers’ tales enlightening.

When is the last t ime you Googled yourself? Go ahead, give it a tr y! What sites come up? What do they say about you and who you are? Are you shown in the best light? If not, what can you do to enhance your image? We hope this issue helps you take that ﬁrst step toward being a better you.

And remember to ﬁnd and follow QP on LinkedIn, Facebook and Twitter! QP

Seiche Sanders Editor

EXECUTIVE EDITOR AND ASSOCIATE PUBLISHER Seiche Sanders ASSOCIATE EDITOR Mark Edmund ASSISTANT EDITOR Amanda Hankel MANUSCRIPT COORDINATOR Valerie Ellifson CONTRIBUTING EDITOR Megan Schmidt COPY EDITOR Susan E. Daniels ART DIRECTOR Mary Uttech GRAPHIC DESIGNER Sandy Wyss PRODUCTION Cathy Milquet ADVERTISING PRODUCTION Barbara Mitrovic

DIGITAL PRODUCTION SPECIALISTS

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

MEDIA SALES ADMINISTRATOR

Kathy Thomas MARKETING ADMINISTRATOR Matt Meinholz EDITORIAL OFFICES Phone: 414-272-8575 Fax: 414-272-1734 ADVERTISING OFFICES Phone: 866-277-5666 ASQ ADMINISTRATION CEO Bill Troy Managing Directors Ajoy Bose Julie Gabelmann Brian J. LeHouillier Michelle Mason Laurel Nelson-Rowe

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

QUALITY PROGRESS

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LOGON

Customized QMS

In response to “Solid Base” (June 2014, pp. 28-33): The sort of customized, in-depth assessment described by the author is performed by many of our customers. In many industries, this practice lays to rest the “promise” that registration to one or more of the internationally recognized quality management system (QMS) stan-dards by qualiﬁed certifying bodies would replace the need for a customized QMS for separate customers: It’s registration and customization.

Phil Scott Downers Grove, IL

FMEA refresher

I just became a member of ASQ, and I wanted to say that the June 2014 edition of QP magazine is fantastic. Most impor-tantly, the article about failure mode and effects analysis (FMEA) (“3.4 Per Million: Conducting FMEAs for Results,” pp. 42-45) was a great refresher. What I appreciated the most was the author’s use of an actual example to highlight his points.

Gregory P. Simmons Nashville, TN

More to add

After reading the Expert Answers response “Defining the Customer” (March 2014, pp. 8-9), I just had to add to the expert’s reply. Briefly, the problem is that a customer oc-casionally sends raw materials to be used in a machining operation and, at times, the material is received nonconforming. The question asked is, “Should these custom-ers who provide raw material be classi-fied as customers or suppliers, and be logged into the supplier base and receive

Seen&Heard

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 Megan Schmidt: @ASQ_Megan [email protected] www.facebook.com/ groups/43461176682 www.linkedin.com/groups/quality-progress-magazine-asq-1878386 reports based on their quality?” The expert

answers: “The bottom line, the customer is still the customer if it supplies the materi-als to be serviced or machined.”

I completely agree with the expert’s answer, but would add that perhaps the underlying cause of this problem lies in the lack of quality assurance requirements being included in the contract. An agree-ment beforehand should have included what to do with customer-supplied materi-als that are received nonconforming by the organization. ISO 9001:2008, Clause 7.2—Customer-related processes closely applies here. It is up to the organization to determine requirements not stated by the customer.

ISO 9001:2008, Clause 8.3—Control of nonconforming product also applies. When the received raw materials did not meet requirements, they should not have been used by the organization unless autho-rized by the customer.

A similar problem occurs when the customer dictates to an organization which supplier they are to buy materials or components from. This differs from the above in that the organization issues the purchase order to the supplier. It should be agreed on up front and in the contract who is responsible for the quality management of the supplier— the customer or the organization. The agreement should include what actions the organization should take if the supplier delivers nonconforming materials or components and who is to absorb the cost for the non-quality issues.

James D. Werner Raritan, NJ

Tune In

The latest ASQ TV episode focused on data management. View the episode to get an overview on data management, from hot topics such as big data to using data to improve quality.

Also, watch for a new episode discussing quality and athletics, available July 15.

Visithttp:// videos.asq.org

to access the full video library.

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QP

QUALITY PROGRESS

PAST CHAIR

John C. Timmerman, Gallup Inc.

CHAIR

Stephen K. Hacker, Transformation Systems International LLC

CHAIR-ELECT

Cecilia Kimberlin, Kimberlin LLC (retired – Abbott)

TREASURER

Chava Scher, RAFAEL – Advanced Defense Systems (retired)

DIRECTORS

Heather L. Crawford, Apollo Endosurgery Raymond R. Crawford, Parsons Brinckerhoff Ha C. Dao, Emerson Climate Technologies Inc. Julia K. Gabaldón, Quality New Mexico Gary N. Gehring, Saskatchewan Ministry of

Government Relations

David B. Levy, Tekni-Plex Flexibles Division Sylvester (Bud) M. Newton Jr., Alcoa Daniella A. Picciotti, Bechtel Steven J. Schuelka, SJS Consulting Kush K. Shah, General Motors James B. Shore, Nipro Healthcare

Daniel E. Sniezek, Lockheed Martin (retired) Joal Teitelbaum, Joal Teitelbaum Escritório de

Engenharia

Alejandra Vicenttin, Vicenttin Organizational Excellence & Kaizen

G. Geoffrey Vining, Virginia Tech, Department of Statistics

Bharat Wakhlu, Tata Services Ltd., Division of Tata Sons

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, Da-vid Burger, Bernie Carpenter, L.N. Prabhu Chandrasek-aran, 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

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:

Which aspect of supply chain optimization would most beneﬁt your organization? • Identifying and partnering with the right suppliers. 36.6% • Managing processes effectively. 28.1% • Eliminating waste within the chain. 19.7% • Auditing suppliers accurately. 15.4% Visit www.qualityprogress.com for the latest question:

What is your favorite social media network? • Facebook. • LinkedIn. • Twitter. • Instagram. • Other.

Q P

QualityNewsTODAY

Recent headlines from ASQ’s global news service

(All URLs case sensitive)

Auto Industry Gets Serious About Lighter Materials

Automakers have been experimenting for decades with ”lightweighting,” as the practice is known, but the effort is gaining urgency with the adoption of tougher gas mileage standards. (http://bit.ly/lightermaterials)

CDC: Two 'Sproutbreaks' Sicken More Than 70

More than 70 people in the United States and Canada have been sickened in two so-called ”sproutbreaks” involving foods made from either sprouted chia seeds or clover, federal investigators say. (http://bit.ly/sproutbreakssicken70)

• Hang out with ASQ bloggers

Watch a live Google+ Hangout with some of the bloggers featured in “Blog Boom” (pp. 16-23) as they discuss the value of social media and how to get involved. The event takes place at 12 p.m. CST on July 23. You can also watch a recording of the discussion later.

• More career moves

Peter Merrill offers more career advice in thr ee sidebars that add to this month’s Innovation Imperative column, ”Making Decisions” (pp. 39-40).

• Illustrated progress

A suppliers, inputs, process, outputs and customers diagram shows the

progress made on the AS9100 revision, the topic of this month’s Standards Outlook column, ”Revision Runway” (pp. 50-52).

• Improvement plan example

See an example of a quality tool used to improve skills and performance, as described in this month’s One Good Idea column, ”Steer Your Career,” p. 64.

www.qualityprogress.com

ONLINE

EXTRAS@

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

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Build an effective QMS

Q: What’s an effective approach for estab-lishing, maintaining and optimizing an ef-fective quality management system (QMS)?

David Stuckey Fort Worth, TX A: The most effective approach is based on demonstrated need for a QMS and sup-ported by the senior management of an or-ganization, meaning the CEO and his or her direct reports. When everyone in an orga-nization understands the need to address quality, there will be buy-in from everyone for a QMS. Consider two examples:

1. Many years ago, there was a prevail-ing perception in the customer base of a large retailer that the retailer sold seconds merchandise (products in which a mistake was made in making the item), even though that was not the case. To address and change this, the CEO of this organization created a quality assurance (QA) division with the director of QA reporting directly to the CEO. The fact that the director of QA at-tended weekly staff meetings with the CEO, along with other direct reports to the CEO, sent a powerful message throughout the retailer as well as the supplier community that quality of merchandise was extremely important to top management.

The organization also effectively used product inspection based on statisti-cal sampling at suppliers’ facilities and retailers’ warehouses; it conducted pre-purchase and post-award product testing to ensure the products met requirements; it passed on information from customer complaints to the suppliers for their con-sideration and actions; and it helped buyers (purchasing officers/agents) establish performance specifications. Using these strategies, the retailer became known for first-class quality across all merchandise categories within two to three years, and its quality system came to be known as

one of the best in the retail industry. 2. In another example, a children’s wear manufacturer had an established QMS, but the director of QA was not getting the necessary resources. Over a few months, he had his staff collect data on scrap, re- jects and rework, and put cost ﬁgures to all

these data. He managed to get 10 minutes of time in the executive vice president’s (EVP) staff meeting and presented on how much money the organization could save with a bit more resource devoted to quality management. This opened the EVP’s eyes to potential savings, and the director of QA got what he needed. From then on, every staff meeting with the EVP opened with a

presentation on quality.

In both of these examples, quality management was strongly supported by senior management. In the ﬁrst case, quality management was driven by customers. In the second case, it was driven by the bot-tom line.

Pradip Mehta Mehta Consulting LLC Coppell, TX

Understanding medians

Q: How robust is “median” as a statistic? Govind Ramu San Jose, CA A: To be clear, the median is the center value of a set of observations taken from a broader population. As such, it is the 50th percentile. If a set of observations in rank order contains an uneven number of them, it is the observation in the middle; if the set contains an even number of observations, it is the mean of the two numbers closest to the middle.

How robust is it?

A statistic is robust if it is resistant to change even when some observations change. The mean of a data set, for ex-ample, will change if any observation in the data set changes. This is not so for the me-dian. Individual observations may wander within limits and the median won’t budge. That property is partially responsible for the median’s appeal. But just how robust is it? You would have to define a specific quanti-tative measure of robustness to say. When is the median appropriate? In theory, if your data set fails the test of normality, and you can’t find a transforma-tion to normality or another suitable

distri-EXPERTANSWE

When everyone in an organization

understands the need to

address quality, there will

be buy-in from everyone for a

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bution that ﬁts, you can always default to a distribution-free test for comparing two or more treatments. Distribution-free tests often rely on the median as a measure of central tendency. Developers of distribu-tion-free tests are careful to examine rela-tive efﬁciency, measured as the ratio of the variance of the distribution-free statistic to the variance of the appropriate statistic under normality (or some other assumed distribution).

The relative efﬁciency of a distribution-free test statistic computed on data that are actually normally distributed is often low. This is one factor that prevents you from abandoning all normal theory statis-tics in favor of distribution-free tests. If the data are normal, using median instead of the mean is often inefﬁcient.

It is important to understand that often, large data sets, even some from an under-lying normal distribution, will fail a formal test of normality simply because the test criteria are very strict. In most practical applications, a straight line on a normal probability plot is sufﬁcient evidence of normality or near-normality. Opinions will differ, but many applied statisticians will stick to normality unless there is clear evidence against it.

In many situations, there may be value in seeking the cause of non-normality. Data may actually come from multiple sources with different means, causing the appear-ance of non-normality in the aggregate data set. A distribution-free test in this environ-ment may be technically correct, but it may

miss the point of getting to the root causes of variation.

Still, when the data set is decidedly not normal and all other avenues have been traveled, the distribution-free test based on medians is appropriate.

How can you prevent the misuse of medians to sway perception?

You can’t. If someone’s paycheck depends on their ability to produce a summary that best supports their argument, little can be done to dissuade them from the practice. However, given the opportunity, you may be able to educate an errant user of medians by showing plots of the data, including a normal probability plot, to point out that the data can be summarized more efﬁciently. Bear in mind, however, that if the distribu-tion is normal, the median and mean will be very close, so there may be little harm done by showing the median in place of the mean. When data analysts use medi-ans, they should provide some justiﬁcation explaining why that choice was made. Are there measures of dispersion for the median that should be published along with them (for example, inter-quartile range)?

An interquartile range may be appropriate, but a statistic showing something closer to the full range of the data might do a better job of persuading the reader of vast uncertainty, assuming it exists. A graphi-cal display, such as a box plot, is useful for showing the variability of the data that are

summarized by the median.

There is a formula for the variance,σ2,

of the median from any population, but it assumes a known distribution:

σ2 = {1/(4n[f (m)]2)}

in which n is the number of observations, f is the density function of the population, and m is its median. In situations in which the distribution function may be assumed— for example, microbiological counts are often approximately lognormal—there may be value in showing the variance or the standard deviation of the median, simply to point out the uncertainty associated with the median.

Lynne B. Hare Statistical consultant

Plymouth, MA

RS

GET YOUR QUESTIONS ANSWERED

At some point, everyone runs into a problem they can’t solve alone. Let QP help.

Submit your question at www.qualityprogress.com, or send it to [email protected],

and our subject matter experts will help you ﬁnd a solution.

(13)

QUALITY COUNCIL OF INDIANA

Our Primers contain study material for the current ASQ bodies of

knowledge plus sample questions and answers. The Primers may be

taken into the exam. The completeness of our materials makes them

the most widely used texts for Certication Training.

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PRIMERS

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Quality Council of Indiana offers detailed solutions to all

questions presented in the corresponding Primer.

CD-ROMS

QCI offers user-friendly interactive software to assist students preparing

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Examinations are timed and summarized graphically. A help le provides

explanations and references. The CDs run on Windows XP and newer.

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CQE CQA CSSGB

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812-533-4215

Telephone Orders

800-660-4215

Internet Orders

www.qualitycouncil.com

Fax Orders

812-533-4216

(14)

Juran’s Quality Handbook

Implementing Six Sigma

The Quality Technician’s Handbook

by Juran & De Feo

The essential quality reference for most ASQ exams

by Forrest W. Breyfogle, III A great CSSBB reference

by Gary K. Grifth

Great for CQT and CQI exams.

LSS Primer

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

RAM

Dictionary

ISO 9001 Internal

Auditing Primer

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Green Belt

ISO Primer

Quality System

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More than 2500 denitions. Great for any ASQ certication.

by Tracy Omdahl

Contains 2800 denitions. Helpful for Reliability and Quality Engineers.

by Bensley & Wortman Presents a thorough treatment of the ISO implementation and

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There are generic manuals on the CD.

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organization, and writing of quality documents. The disk contains by Greg Wies & Bert Scali

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

The Spanish version of the CSSGB Primer.

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Performs all measurements required in the AIAG manual. Contains ANOVA methods and excellent graphs.

Quality

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En Español CSSGB PRIMER ISO QSH

(15)

L

GOVERNMENT

Culture, Cover-ups Plague VA Health System

Appointment delays, inaccurate reporting and varied quality of care found

KEEPINGCURRE

Last fall, Thomas Breen, a 71-year-old U.S. Navy veteran noticed blood in his urine. With a history of bladder cancer, Breen called his Veterans Affairs (VA) hospital in Phoenix for a follow-up appointment. He had to wait months to get in. In the meantime, his family took him to a private hospital where he was diagnosed with bladder cancer. As Breen’s daughter-in-law told the Los Angeles Times, when the VA called in early December to schedule an appointment, she informed the scheduler it was too late—Breen had died on Nov. 30.1

At another VA health facility, just a few weeks into his new job as a scheduling clerk at a VA clinic in Austin, TX, Brian Turner was instructed to “cook the books.”

“They said, ‘You gotta zero out the date. The wait time has to be zeroed out,’” Turner told the Washington Post .2

“Zeroing out” was a workaround for the VA’s accountability system, which was monitored by supervi-sors in Washington, D.C., to ensure patients weren’t waiting too long for appointments. When a patient would ask for an appointment on a speciﬁc day, Turner would search for the next available time—which was usually

several days later. When the patient agreed to the later date, Turner would type that the patient requested the later day. Suddenly, a wait time that may have been much longer was reported as zero days.3

Occurrences like these are why an investigation was launched into allega-tions that VA healthcare facilities were manipulating patient waiting lists to hide long delays in access to care. The Phoenix VA healthcare system is at the center of the scandal—managers there are being accused of falsifying records to make it

appear patients were being seen within the VA’s standard for a timely appointment, which is about 14 days. In actuality, patients in Phoenix waited an average of 115 days for an appointment, and secret waiting lists were kept to hide the true wait times.4

A nearly month-long internal audit com-pleted in early June shows these problems are systemic across the wider VA health-care network. The audit of 731 VA facilities and nearly 4,000 employees found nearly 60,000 veterans were waiting for appoint-ments at VA health facilities, and 70% of VA facilities have used alternative scheduling methods so wait times appear shorter. More than 10% of scheduling staff reported

they were instructed to alter patient ap-pointment scheduling.5

Backtracking on progress

The VA Health Administration (VHA) is the largest integrated healthcare network in the United States with 1,700 hospitals, clin-ics, counseling centers and nursing homes throughout the country.6

In the past, the VA healthcare system has been viewed as a leader in medical advances, especially when it comes to gathering and releasing performance data.

In 2011, it began publishing hospital medi-cal complication and surgimedi-cal death rates based on a national surgery quality im-provement program. An internal database called Strategic Analytics for Improvement and Learning (SAIL) tracks procedure out-comes and ranks VA hospitals on various safety measures for benchmarking.7

The VA healthcare system’s patient satisfaction scores are high—a 2013 survey by VA found 93% of patients said they had a good experience when they r eceived care. A 2005 comparison of VA patient medical records with a national sample found bet-ter quality of care at the VA, especially for depression, diabetes, high cholesterol and

hypertension.8

So, how did access to care be-come a problem?

Part of the cause has been at-tributed to a shortage of doctors— particularly primary care physicians— coupled with an increased demand for VA healthcare. The American Federation of Government Employees reports some VA doctors carry work-loads of more than 2,000 patients. The goal set in the VHA handbook is 1,200.9

Preliminary audit results sent to Presi-dent Barack Obama pointed to an “overarch-ing environment and culture which allowed this state of practice to take root.”10

Consider the accountability reporting system that was supposed to make officials in Washington, D.C., aware of problems in the field through data. Instead, a culture of manipulating data to hide deficiencies developed, and employees risked backlash for pointing out patient care issues.11

Even when ofﬁcials learned this was hap-pening, as they did in 2005, and attempted

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NT

NAME: Bryan T. Blunt. RESIDENCE: Eloy, AZ.

EDUCATION: MBA from Western International Univer-sity in Tempe, AZ.

INTRODUCTION TO QUALITY: While Blunt considered product quality to be a top priority

throughout his working career, the light really came on regarding process quality when he was a manufacturing engineer at Al-liedSignal.

PREVIOUS JOBS: Director of quality for Textron Systems Inc.,

director of quality for Lycoming Engines and director of supply chain quality for Cessna Aircraft Co.

CURRENT JOB: President, Quality Works Consulting LLC. ASQ ACTIVITIES: Past section chair of two ASQ sec-tions and immediate past nominating chair of ASQ Phoenix Section.

ACTIVITIES/ACHIEVEMENTS: One of the earliest Black Belts certiﬁed at AlliedSignal, where the ﬁrst large-scale deployment of Six Sigma took place after its initi al development. Received Textron Six Sigma’s presti-gious “Top Gun” award. Currently a doctoral student in organizational leadership at Grand Canyon University in Phoenix. Involved in several areas of church ministry. PUBLISHED WORKS: Author of Turnaround: The Quality Path to Saving the Business (QW Press LLC, 2011). RECENT HONORS: Blunt was part of the 2013 class of ASQ fellows.

PERSONAL: Married, three sons and eight grandchildren. FAVORITE WAYS TO RELAX: Reading, playing the guitar and spending time with his wife and their pet labradoodle.

QUALITY QUOTE: “There are no great businesses that are not excellent in terms of quality.”

Q

Who’s Who in

to address the issue, honest reporting wasn’t enforced.

“Because of the fact that the gaming [manipulating the system] is so prevalent, as soon as something is put out, it is torn apart to look to see what the workaround is,” said William Schoenhard, who was working as the deputy undersecretary for health for operations and management in 2005. “There’s no feedback loop.”12

Furthermore, while the criticism and investigation of the VA healthcare system has revolved around patient wait times for appointments, SAIL data show there is another serious problem within the VA healthcare system— widely varying patient care results among VA facilities and what experts call “a slippage of quality” at some facilities.13

Next steps

On May 30, Eric Shinseki, the Department of VA secretary, resigned. Shinseki said he was unaware of the access to care and reporting issues engulfed in the system. Following the results of the internal audit, an exter-nal, independent audit of scheduling practices will take place.14

As the VA healthcare system looks to ﬁx its systemic issues related to access to and quality of care, reﬁning its performance-metric reporting system will be key.

According to William E. Duncan, who supervised the publication of medical outcomes until 2012, “The goal was not for hospitals to be aver-age performers. The goal was to be in the top 10%. Our patients have little recourse, and they rely on our staff to tell them the truth. We can’t forget that medical quality is not just access to care.”15

—Compiled by Amanda Hankel, assistant ediitor

REFERENCES

1. David Zucchino, Cindy Carcamo and Alan Zarembo, “Growing Evidence Points to Systemic Troubles in VA Healthcare System,” Los Angeles Times, May 18, 2014, www.latimes.com/nation/la-na-va-delays-20140518-story.html#page=1.

2. David A. Fahrenthold, “How the VA Developed Its Culture of Coverups,” Washington Post , May 30, 2014, www.washingtonpost.com/sf/national/2014/05/30/how-the-va-developed-its-culture-of-coverups. 3. Ibid.

4. Sandhya Somashekhar, “S ome of the Internal Problems That Led to VA Health System Scandal,” Wash-ington Post , May 30, 2014, www.washingtonpost.com/national/health-science/some-of-the-internal-problems-that-led-to-va-health-system-scandal/2014/05/30/399095b4-e81e-11e3-8f90-73e071f3d637_ story.html.

5. Ben Kesling, “Nearly 60,000 Veterans Face Delays Receiving Health Care—VA Audit,” Wall Street Jour-nal, June 9, 2014, http://online.wsj.com/articles/over-100-000-veterans-face-delays-receiving-health-careva-audit-1402339138.

6. Somashekhar, “Some of the Internal Problems That Led to VA Health System Scandal,” see reference 4. 7. Thomas M. Burton and Damian Paletta, “Veterans Affairs Hospitals Vary Widely in Patient Care,” Wall

Street Journal, June 3, 2014, http://online.wsj.com/articles/veterans-affairs-hospitals-vary-widely-in-patient-care-1401753437 .

8. Somashekhar, “Some of the Internal Problems That Led to VA Health System Scandal,” see reference 4. 9. Ibid.

10. Michael D. Shear and Richard A Oppel Jr., “V.A. Chief Resigns in Face of Furor on Delayed Care,” New York Times, May 30, 2014, www.nytimes.com/2014/05/31/us/politics/eric-shinseki-resigns-as-veterans-affairs-head.html.

11. Zucchino, “Growing Evidence Points to Systemic Troubles in VA Healthcare System,” see reference 1. 12. Fahrenthold, “How the VA Developed Its Culture of Coverups,” see reference 2.

13. Burton, “Veterans Affairs Hospitals Vary Widely in Patient Care,” see reference 7.

14. Kesling, “Nearly 60,000 Veterans Face Delays Receiving Health Care—VA Audit,” see reference 5. 15. Burton, “Veterans Affairs Hospitals Vary Widely in Patient Care,” see reference 7.

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KEEPINGCURRENT

STANDARDS

ISO 9001 DRAFT AVAILABLE

FOR PUBLIC COMMENT

ISO 9001—Quality management systems—Requirements, the most widely used International Organization for Standardization (ISO) standard, has been made available as a draft international standard (DIS), a key milestone in its revision process.

As all ISO standards, ISO 9001 is reviewed every five years and is now be-ing revised to ensure it is relevant and updated. At the DIS stage, all inter-ested parties can submit feedback that will be considered before the final draft is published by the end of 2015. In addition, the draft version now can be purchased, giving organizations the opportunity to get a taste of the new standard before the final publication date.

Comments will be accepted until July 15. For more details, visit http://asq. org/standards-draft-iso-9001-2015.html. Only U.S. stakeholders can provide public comments. Other stakeholders can purchase the standard or contact their National Standardization Bodies to learn how they can contribute.

SHORTRUNS

THE INTERNATIONAL CONFERENCE on Quality 2014—Tokyo will be held Oct. 19-22. The conference takes place every three years and is sponsored by ASQ, the European Organization for Quality and the Union of Japanese Scientists and Engineers. Visit ww.juse.or.jp/e/conventions/202. THE SOCIETY OF Automotive Engineers (SAE) Foundation received a $75,000 grant from the Chrysler Foundation to continue providing science, technology, engineering and math education programming to K-8 stu-dents. An SAE program called “A World in Motion” gives younger students opportunities to learn about math and science concepts. For more details, visit www.sae.org/news.

Mr. Pareto Head

BY MIKE CROSSEN

A recent report sent to President Barack Obama called out the Malcolm Baldrige National Quality Award as an opportunity “for raising awareness of performance excellence” in the U.S. healthcare system.

In the 66-page report released in late May, the President’s Council of Advisors on Science and Technology (PCAST) offered seven recommendations to Obama, “all of which support and reinforce each other as components of a strategy to improve the quality of delivery of healthcare and the health of Americans through systems engineering,” the report said.

The Malcolm Baldrige National Quality Award was speciﬁcally mentioned in the sixth recommendation: “Establish awards, challenges and prizes to

promote the use of systems methods and tools in healthcare.”

The report continued: “Health and Human Services and the Department of Commerce should build on the Baldrige award to recognize healthcare providers successfully applying system engineering approaches.”

The report, titled “Better Healthcare and Lower Costs: Accelerating Improvement Through Systems Engineering,” can be accessed at http://tinyurl.com/ pk23tq9. BALDRIGE AWARD

BALDRIGE SINGLED

OUT IN REPORT TO

PRESIDENT OBAMA

ON HEALTHCARE

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United Arab Emirates’ Dubai Aluminium and Argentina’s Tgestiona were awarded gold-level status at ASQ’s International Team Excellence Awards after showcasing how they increased quality and ﬁnancial savings at their respective organizations.

ASQ announced the gold-level winners—along with silver and bronze—at its recent World Conference on Quality and Improvement, which was at-tended by nearly 2,800 people. In the awards’ 29th year, 39 teams from 14 countries competed.

Dubai Aluminium’s stub repair reduction team used lean Six Sigma and the deﬁne, measure, analyze, improve and control method to slash repair costs by re-ducing product damage from 6% to 3%, resulting in $1.3 million in annual savings.

Tgestiona’s matter of time team used Six Sigma to address the process for handling customer access to the company’s systems, which affects more than 20,000 users of 256 systems. The results included reducing the error rate from 10% to 0.05%, and reducing processing time from 26 days to fewer than three days.

For more information about the award recipients and the team excellence award process, visit http://asq.org/wcqi/team-award. ASQ TEAM EXCELLENCE AWARDS

TWO TEAMS REACH GOLD STATUS AT ASQ COMPETITION

ASQNEWS

ASQ RECEIVES AWARD ASQ achieved the excellence level of achievement from Wisconsin Forward Award Inc., the state award’s top recognition. The award is modeled on the Malcolm Baldrige National Quality Award frame-work, process and criteria. ASQ will join other Wisconsin-based organizations receiving the award at ceremonies in December. For more information about the award, visit www.wisquality.org/ wfa/wfa.

SCHOLARSHIP RECIPIENT ASQ’s Healthcare Division awarded its annual $2,000 Nightingale Scholarship to Ellen Martin, a doctoral student in the school of nursing at the Universit y of Texas-Austin. Martin was recognized for demonstrating an outstanding commit-ment to pursuing quality improvecommit-ment in the healthcare ﬁeld. For more infor-mation about Martin and the award,

visit www.asq.org/media-room/press- releases/2014/20140512-nightingale-scholarship-winner.html.

NEW CASE STUDY ASQ’s Knowledge Center released a new case study about India-based Max Life Insurance and how it improved customer reten-tion through Six Sigma and quality tools. The improvement project nearly tripled Max Life’s customer reten-tion rate and generated more than $8.6 million in revenue. Read more at http://asq.org/knowledge-center/case- studies-max-life-improves-customer-retention.html.

LSS TRAINING OFFERED Redesigned lean Six Sigma Green Belt and Black Belt courses are being of fered by ASQ. The courses will teach participants to use lean and Six Sigma tools to improve workﬂow and reduce inefﬁciency. The

peer-reviewed courses, created and taught by Master Black Belt industry experts, include instructor-led class-room training and one-on-one coach-ing. For more information or to register, visit www.asq.org/sixsigma-elite. NEW ISO/IEC TRAINING ANAB un-veiled new training on ISO/IEC 17021, Conformity assessment—Requirements for bodies providing auditing and certi-fication of management systems. The training will provide an understanding of the requirement s of ISO/IEC 17021 and its relationship with other certifica-tion scheme standards and Internacertifica-tion- Internation-al Accreditation Forum documents. The course also includes information about potential developments related to the revision of ISO/IEC 17021, scheduled for release in late 2014. For more informa-tion, visit www.anab.org/resources/ anab-training.

MEMBERS OF United Arab Emirates’ Dubai Aluminium stub repair reduction team celebrate their gold-level accomplishment at ASQ’s International Team Excellence Awards.

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BLOG

Blogging keeps growing,

remaining a relevant

way to

share, learn

and network

Blogging keeps growing,

remaining a relevant

way to

share, learn

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SOCIAL MEDIA

BACK IN THE

late 1990s—well before 140-character

Tweets, Facebook posts and LinkedIn discussions—there was

the blog.

Register at any number of blogging sites and you could

set up your own personal or professional website to report

and record information, showcase your talent and expertise,

share opinions and theory, and relay across the world

any-thing from photos to links to video—all in one place.

But are blogs still relevant? Have they been surpassed by

other social networking sites?

Google’s Blogger site has more than 46 million unique

visitors each month. About 6.7 million people write on

blogging sites, and 12 million blog via social networks.

1

More organizations are getting in on the act, too. The use of

corporate blogs has shot up to 34% in the last two years—a

nearly 50% increase.

2

Clearly, a lot of people still use blogs to push out

infor-mation, messaging and opinion, and even more continue to

consume the words and join in the dialogue.

What keeps millions writing blogs and reading them?

We posed this question to a few members of ASQ’s

Inﬂuen-tial Voices blogging group and asked them to describe their

blogging experiences. We also asked the bloggers about the

difference blogging makes in their professional lives. How did

their own careers shift because they dared to venture into

the blogosphere?

Perhaps their words and ideas will inspire you to log on,

speak up and join the online opportunities within what

remains a popular medium for learning, creating, sharing and

networking.

REFERENCES

1. Douglas Karr, “The Blogconomy Blogging Statistics (Infographic),” Social Media Today, Aug. 26, 2013, http:// socialmediatoday.com/douglaskarr/1696221/infographic-blogconomy-blogging-statistics.

2. Nora Ganim Barnes, Ava M. Lescault and Stephanie Wright, “2013 Fortune 500 Are Bullish on Social Media,” Charlton College of Business Center for Marketing Research, University of Massachusetts Dartmouth, www.umassd.edu/cmr/ socialmediaresearch/2013fortune500.

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QP: Why do people write blogs?

Daniel Zrymiak (DZ):

People have a particular message or impression they wish to communicate. Through blogging, they can establish and entrench a connection with their audience or community. Blogs provide additional ﬂexibility to incorporate visuals and audio, and embed hyperlinks to extend the breadth and depth of the article’s scope. People should write to initiate an interactive connection with readers on an interesting subject or idea.

Mark Graban (MG):

I started my blog in 2005 because I was frequently emailing articles about lean to colleagues. I realized I could post them on a blog, and people could pull information instead of having it pushed to them via email. I also realized I could reach a broader audience and use the blog as a way to meet new people in the lean world.

John Hunter (JH):

People blog to share their ideas. A blog can be a creative outlet on a work topic or another topic. I blog about management and also about investing, travel, engineering, technology and other topics that interest me.

QP: Why is blogging right for you?

DZ:

In my personal situation, I must frequently travel or change plans on short notice. This has the unfortunate effect of forcing cancellations of previous commitments. For ex-ample, it is regrettable to have submitted an abstract to present at a conference, have it accepted by a review committee, be scheduled to present, and then need to inform those same supportive team members that I have to decline the opportunity to present and en-gage their conference audience. In contrast, blogging works because it provides me with the maximum level of ﬂexibility and the ability to customize my message.

MG:

I love blogging, and I’ve kept at it nearly every weekday for the last nine years. As with any sort of writing, I think you have to do it because you want to write and because you enjoy it. Too many blogs ﬂame out after just a few weeks or months. Maybe the bloggers who gave it up were motivated to start because they felt like they “had to blog.” Writing must be a passion—whether it’s a blog or a book—and it’s not right for everybody. Some folks like to write occasionally, and submitting occasional magazine or journal articles might be a better ﬁt. Some people can podcast or create videos.

JH:

I have been blogging for 10 years, which is more than enough time to convince me it is right for me. Blogging ﬁts my personality—I like short delivery cycles. I don’t like the idea of working on a project that takes a year to reach the audience or customers. With blogging, I can have an idea, and in an hour I can share that with people across the globe. Blogging is similar to agile software development in this way: minimize work-in-progress and deliver working software—or in blogging, text—to users as quickly as possible. Then iterate and extend.

To a much larger extent than most bloggers, I also take advantage of hypertext—linking to other related online content. This is also a wonderful thing. Again, it ﬁts my personality. I wrote a book called Management Matters: Building Enterprise Capability (http://curious-cat-media.com/management-matters), and it had to be an e-book because I’m constantly linking to other parts of the book and resources online.

While writing the book, I thought about how constrained I would feel writing an “old style” book with no hypertext capability. I think I would have quit before I ﬁnished.

QP: Why do you blog?

DZ:

I am not a commercial blogger. I am not promoting a practice, nor am I a center of inﬂuence to recommend products and services. Primarily, I blog to use this communication

HOME ABOUT HELP CONTACTUS BLOG

The Benefits of Blogging

Tuesday, July 1, 2014, 12:01 am 5 comments Search

• “Real Time, Interactive and

Dynamic,” p. 20.

• “Build Credibility and

Reputation,” p. 22.

• “More Active

Networking,” p. 23.

Google+

Hangout

Follow a link to watch a live Google+ Hangout with some of the bloggers featured in “Blog Boom.” The blog-gers will discuss the value of social media to quality professionals and how to get involved. The live event takes place at 12 p.m. CST on July 23. You also can watch a recording of the discussion later.

(22)

channel to present viewpoints and opinions on the pertinent quality issues of the day. For this reason, I enjoy participating within the ASQ Inﬂuential Voices framework to realize and expand the synergistic beneﬁts of collaborative communication.

MG:

As I said in this video at www.youtube.com/watch?v=gfUJLSRgDt0 (case sensitive), I blog to learn, and I really mean that. Sure, sometimes I like to get on a soapbox and share my own views, but my goal is to learn. Having a blog means I keep up on reading new ma-terial that’s out there in the lean world—in the news and otherwise. Writing is a great way to practice articulating views and a way to practice teaching—skills and experience that translate into my consulting work and speaking. I love it when we have good discussion in blog comments, especially when people disagree because that leads me to sometimes changing my own views—to learn.

JH:

One of the nice things is how easy it is to blog. I managed several websites for years before I started blogging (which is quite rare). Dealing with a typical website is much more work than blogging. With a blog, you can have the idea and be up and running with your new blog post in 10 minutes, using something like www.wordpress.com. How easy it is to blog is one factor.

Another thing I like is being able to refer back to my thoughts on a topic. This is not something I have ever heard someone else mention as a reason for blogging, but one of the ways I use blogs is as a resource I can go back and use later.

I also blog as a way to build a personal brand. When people are introducing me to a colleague, I am often introduced to people as the author of that “Curious Cat” blog and website. I have never been introduced as the author of my book.

QP: What are your goals in blogging?

DZ:

I aspire to introduce topics and subjects that interest me personally and add value to the profession and to subjects that I believe should be more actively promoted by the profession. Based on my experience, the most impactful decisions are made when ﬁnancial and governance considerations are incorporated into the decision process. My inclination is to justify the involvement of quality people within these ﬁnancial and governance activi-ties, thus transcending the traditional role of inspection and compliance.

JH:

When I originally started providing content online (even before blogs), one of my big goals was to help people improve management. There are many good management ideas and practices that are decades old and yet ignored. I thought—and still do think—a big part of the problem is people haven’t seen good management ideas.

With blogging, I continue to attempt to help people apply proven management practices. Building a personal reputation and learning are other reasons I continue.

I think a big problem is that people ﬁnd bad management advice (even on good man-agement concepts), use it, get frustrated and don’t believe better manman-agement practices really work. So they experience lousy implementation of good ideas and decide the ideas are bad.

For example, lean thinking has great value, but the way it is done in many places leaves people with the impression that lean is bad management. Or they read about or get trained on lean or W. Edwards Deming, but the way the information is presented doesn’t provide a convincing case for the value of the management advice.

By helping people ﬁnd better advice, I can help improve the success rate of adopting practices such as customer focus, respect for people, managing with an understanding of