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QUALITY PROGRESS | OCTOBER 2013 SOCIAL RESPONSIBILITY VOLUME 46/NUMBER 10 Putting Best Practices to Work QUALITY PROGRESS P www.qualityprogress.com | October 2013 Switch the sequence: A new approach to a traditional tool p. 18 5S Environmental management system reaps results p. 24 Energy-saving approaches p. 32 Plus:

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Page 1: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

Qu

ality Pro

gress | o

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ber 2013 so

cia

l resPon

sibility Vo

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Putting Best Practices to Work

QUALITY PROGRESS

P www.qualityprogress.com | october 2013

switch the sequence: a new approach to a traditional tool p. 18

S

S

SS

S5S

Environmental management system reaps results p. 24

Energy-saving approaches p. 32

Plus:

Page 2: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

What’s Online in the ASQ Knowledge Center?

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

CASE STUDYUnitedHealth Group: Overcoming Organizational Resistance

Learn about tools and techniques UnitedHealth Group uses during change management. A process release management framework helps plan and deploy technology process changes, and an integrated organizational change management framework helps increase adoption and provides a better change experience for stakeholders.

QUOTE OF THE DAY

“Where is quality made? Quality is made in the boardroom.” - W. Edwards Deming

Every day the Knowledge Center brings you a different one-sentence take on the world of quality. You can also see recently featured quotes and contribute your own to be added to the collection.WEbCAST

Auditing the Process-Based QMS

Jack West and Charles Cianfrani, co-authors of How to Audit the Process-Based QMS, Second Edition, explain the basics of internal quality auditing and process auditing. This two-part webcast covers topics from preparing for and planning an audit, to conducting the audit, to preparing the audit report.

CERTIFICATION MEMbERSHIP PUbLICATIONSTRAININg CONFERENCES

Page 3: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

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Receiving Inspections

Product DataManagement

Process

QMS

Page 4: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

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Page 5: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

Putting Best Practices to Work | October 2013 | www.qualityprogress.com

ContentsFEATURES

• Rethink 5S Author Audio features John Casey discussing how one organization put a new spin on an old quality tool, the subject of this month’s cover story, “5S Shakeup” (pp. 18-23). • Weigh In Rate and comment on our feature articles and tell us what you think.

• Volviendo a los Fundamentos Back to Basics translated in Spanish.

• Ready Reference Brush up on quality fundamentals, including your vocabulary, with our handy glossary.

www.qualityprogress.comOnly @

LEAN 5S ShakeupTo keep operations from drifting back into disarray, a manufacturer and one of its suppliers switched up the sequence of 5S and kept order and efficiency intact.

by John Casey

SOCIAL RESPONSIBILITYFor the Greater GoodOne Australian laboratory reduced waste, saved money and better engaged its staff after implementing an environmental management system and becoming ISO 14001-certified.

by Tony Badrick, Sue Kehrer and Elizabeth Reid ENERGYTurned OnQuality professionals can make a positive impact on the business sustainability of their organizations by embracing key energy management principles and their obvious connections to quality.

by Natalia Scriabina and Gary Cort LEANGet There FasterA modified value stream map containing elements of spaghetti diagrams and 5S opened the pathway for one manufacturer to make its workplace more efficient.

by Jonathon L. Andell

18

24

32

39

24

S

S

SS

S

18

Page 6: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

QP • www.qualityprogress.com4

LogOn• Dealing with a deluge of documents.

Expert Answers• Choosing a sampling plan.• Looking for special processes during an audit.

Keeping Current • Concerns over poultry processed in China.• ASQ CEO announces retirement plans.

Mr. Pareto Head

QP Toolbox

QP Reviews

DEPARTMENTS

Up FrontA new spin on 5S.

PerspectivesAssisting in the STEM effort.

Career CornerDeploying employee satisfaction surveys the right way.

Standards Outlook Preventing regulatory nightmares.

Quality in the First PersonProfessor stresses the importance of certifications to students.

Back to Basics Export your lessons learned to spark innovation.

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

Email Follow protocol of first initial and full last name followed by @asq.org (for example, [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 GuidelinesTo 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 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 MicroformArticle photocopies are available from ASQ at 800-248-1946. To purchase bulk reprints (more than 100), contact Barbara Mitrovic at ASQ, 800-248-1946. For microform, contact ProQuest Information and Learning, 300 N. Zeeb Road, Ann Arbor, MI 48106, 800-521-0600 x2888, international 734-761-4700, www.il.proquest.com.

Membership and Subscriptions For more than 60 years, ASQ has been the worldwide provider of information and learn-ing opportunities related to quality. In addi-tion, ASQ membership offers information, networking, certification and educational opportunities to help quality profession-als obtain practical solutions to the many problems they face each day. Subscriptions to Quality Progress are one of the many benefits of ASQ membership. To join, call 800-248-1946 or see information and an application on p. 2.

List RentalsOrders for ASQ’s member and nonmember buyer lists can be purchased by contacting Michael Costantino at the Infogroup/Edith Roman List Management Co., 845-731-2748 or fax 845-620-9035.

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 $15 per copy; nonmembers $23 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. © 2013 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.

- INSPIRING WORDS Readers share their favorite quality-related quotations.

- CULTURE IN THE CLASSROOMA lesson about teaching quality in China.

QP

5

12

46

48

51

80

6

8

14

17

52

54

NEXT MONTH

SPECIAL SECTION2013 ASQ QUALITY RESOURCE GUIDE p. 56

51

14

Page 7: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

upfront

retooling 5SA new take on a traditional tool

even quality traditionalists can agree that sometimes foundational tools

can be tweaked to provide more effective, desirable results in specific situations.

Take 5S—sort, shine, set in order, standardize and systematize. The tool, used

to create workspace order and efficiency, certainly works in its original form. But,

contends author John Casey in the article “5S Shakeup,” with the steps in that order,

results have been known to backslide.

Casey offers a twist on traditional 5S intended to ensure positive outcomes stick.

Find out about how he shook up 5S beginning on p. 18.

For obvious reasons, reducing excess resource use makes sense—for the environ-

ment, in reducing cost and creating higher efficiency. “For the Greater Good,” p. 24,

details how a laboratory in Australia implemented an environmental management

system, which led to cost savings and reduced waste. An added bonus? Employee

engagement saw an uptick.

Similarly, energy management and reduction is another timely topic as organiza-

tions attempt to reduce costs and meet customer requirements. “Turned On,” p. 32,

explains how quality professionals can be involved in this growing trend.

“ ... Energy savings has become a quality attribute required to satisfy stated or

implied customer needs,” the authors wrote. “Knowing the different aspects of energy

efficiency and what influences this quality attribute, and understanding key principles

of energy management and its connections to quality will help quality professionals

contribute to these initiatives and make a positive impact on the business sustainabil-

ity of their organizations.”

Finally, next month is World Quality Month—a special time to recognize the impact

and importance of quality around the world. Look for many opportunities to partici-

pate and celebrate throughout November. Or, take a few minutes to contribute your

quality story on the World Quality Month website, http://asq.org/world-quality-month/

share-your-story.aspx. QP

Seiche Sanders

Editor

ExEcutivE Editor andassociatE PublishErSeiche Sanders

associatE EditorMark Edmund

assistant EditorAmanda Hankel

manuscriPt coordinatorValerie Ellifson

contributing EditorMegan Schmidt

coPY EditorSusan E. Daniels

art dirEctorMary uttech

graPhic dEsignErSandy Wyss

Production Cathy Milquet

advErtising ProductionBarbara Mitrovic

digital Production sPEcialistsLaura franceschiJulie Schweitzer

mEdia salEsnaylor LLCLou BrandowKrys D’Antonionorbert Musialrob ShaferDonnie tuttle (ASQ tV)

mEdia salEs administratorKathy thomas

markEting administratorMatt Meinholz

Editorial officEsphone: 414-272-8575fax: 414-272-1734

advErtising officEsphone: 866-277-5666

asQ administrationcEo paul E. Borawski

managing directorsAjoy BoseJulie GabelmannBrian J. LeHouillierMichelle MasonLaurel nelson-rowe

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

QualitY ProgrEss

QP

october 2013 • Qp 5

Don’t forget to watch the new episode

Page 8: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

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

QP • www.qualityprogress.com6

logonHandling electronic avalanchesIn response to “Avoiding an Avalanche”

(May 2013, pp. 22-27): While the author

makes a strong case for discarding

manual document control systems, I think

a description of electronic solutions, or

their desired characteristics, would have

complemented the article nicely.

Some electronic solutions offer little

or no improvement over manual systems.

Storing office documents on a server, for ex-

ample, is no big improvement regardless of

folder organization. Sharepoint implementa-

tions can easily get buried in the avalanche

mentioned unless specific procedural steps

are implemented to avoid this.

As the author points out, increasing

quality usually requires increasing docu-

mentation. But with traditional document

management systems (manual or electron-

ic), the increasing complexity of documenta-

tion becomes unmanageable. The difficulty

in finding documents and learning how

they interrelate grows much faster than

the number of documents themselves. This

leads many to keep minimal documentation,

which is a recipe for minimal quality.

A search function in electronic systems

is great, but it still has limited value because

even if it helps with finding documents, it

rarely simplifies how documents interrelate.

Electronic document management

only has a hope of beating the complex-

ity avalanche by enabling the creation of

a small-world network of documents. A

small-world network is one in which every

document is connected to every other

document by a small number of clicks

(preferably, two to four). Building the net-

work has to be done procedurally to work.

It can and should be specified right in the

Seen&Heard

QP’S MoSt populararticleS(All URls case sensitive)

1. Crunching the Numbers: Get the details behind QP’s 2012 Salary Survey. (http://bit.ly/crunchnumbers)

2. Corrective vs. Preventive Action: Know the difference between corrective and preventive action. (http://bit.ly/correctvsprevent)

3. Standard Wise: read how viewing iSo 9001 in a new light could boost business management. (http://bit.ly/ standardwise)

4. Measuring Up: How does your organization compare to others around the world? (http://bit.ly/measuringup)

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

document creation procedure. Contex-

tual links and category-navigation panels

are the most useful tools in reducing

documentation complexity, and these

tools are incredibly easy to build in some

systems, like wikis.

So for an electronic solution to be a

real improvement over manual document

management, the most important feature

is that the software allows creation of an

effective small-world network of docu-

ments. This feature transforms document

management and data management into

true knowledge management.

Pancho Castano

Cypress, TX

Social buzzWhat readers are saying on social media:

on Twitter:

@JenniferLeny: ISo 9001:2015 is

coming! How can your organization uti-

lize ISo 9001 to lift business performance

to new heights? http://goo.gl/nVtlJA

@ASQ: Popular! new Quality in the

First Person: A husband and wife use

quality tools to strengthen their union.

http://ow.ly/oKnBi

on Facebook:

Joshua Young in response to Expert

Answers article, “Correction vs. Cor-

rective Action,” (August 2013, p. 8):

Corrective action operates at a higher

level of Bloom‘s order of thinking skills.

It applies more consensus building,

empirical research methods and systemic

improvement. Correction is more direct,

involving an individual situation. In orga-

nizations, we need both. Performing as a

group, at high thresholds, is the end goal.

Yet, deviations from the standard must

also be addressed through correction if

they are isolated and uniquely identifiable.

Page 9: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

october 2013 • QP 7

QPQUALITY PROGRESS

PAST CHAIRJames J. Rooney, ABS Consulting, global

government Division

CHAIRJohn C. Timmerman, gallup Inc.

CHAIR-ELECTStephen K. Hacker, Transformation Systems

International

TREASURERChava Scher, RAFAEl—Advanced Defense Systems

(retired)

PARLIAMENTARIANKarla Riesinger, ASQ

DIRECTORSHeather l. Crawford, Apollo EndosurgeryRaymond R. Crawford, Parsons BrinckerhoffHa Dao, Emerson Climate Technologies Inc.gary n. gehring, Saskatchewan Ministry of

governmental RelationsKathleen Jennison goonan, M.D., goonan Performance StrategiesEric A. Hayler, BMW Manufacturing Co.James M. loseke, Sargento Foods Inc.Joanne D. MayoElías Monreal, Industrial Tool Die and EngineeringRichard A. Perlman, Bayer HealthCareSteven J. Schuelka, Calumet CollegeDaniel E. Sniezek, lockheed Martin (retired)g. geoffrey Vining, Virginia Tech Department of

StatisticsAlejandra Vicenttin, Alejandra Vicenttin AdvisorsBharat Wakhlu, Tata Services ltd., a division of Tata SonsJ. Eric Whichard, JE Whichard and Associates

QP EDITORIAL REVIEW BOARDRandy Brull, chair

Administrative Committee Brady Boggs, Randy Brull, Jane Campanizzi, larry Haugh, Jim Jaquess, gary Maclean,R. Dan Reid, Richard Stump

Technical reviewersAndy Barnett, 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, John Richards, James Rooney, Brian Scullin, Amitava Sengupta, A.V. Srinivas, Joe Tunner, Manu Vora, Keith Wagoner, Jack Westfall, Doron Zilbershtein

QuiCk Poll RESulTS Each month at www.qualityprogress.com, visitors can take an informal survey. Here are

the numbers from last month’s Quick Poll:

What is the largest challenge in implementing quality at your organization? • Understanding and meeting customer requirements. 42.8%

• Driving continuous improvement. 34.2%

• Adding value to processes. 11.4%

• Measuring process performance. 11.4% Visit www.qualityprogress.com for the latest question:

What stage is your organization in when it comes to implementing environmental sustainability initiatives? • ISo 14001-certified and have environmental management system (EMS).

• not ISo 14001-certified, but have EMS in place.

• EMS implementation has been discussed, but don’t practice many sustainability

initiatives.

• Don’t practice any sustainability initiatives and have no plans to.

QP

QualityNewstodayrecent headlines from aSQ’s global news service(All URls case sensitive)

‘Pink Slime‘ Returns to School LunchesThousands of schools across the United States rushed last year to stop feeding their

students meat that contained the ammonia-treated beef, known by industry as lean

finely textured beef. But data show schools in four more states have since put aside

concerns and resumed buying the controversial product. (http://bit.ly/pinkslimeback)

NASA Tests Limits of 3-D Printing With Rocket EngineThe largest 3-D printed rocket engine component ever tested was used during an en-

gine firing that generated a record 20,000 pounds of thrust. Innovations such as additive

manufacturing, or 3-D printing, foster new and more cost-effective capabilities in the

U.S. space industry. (http://bit.ly/nasatestslimits)

• New Take on the Tried-and-True In this month’s Author Audio, listen to John Casey, the author of this month’s cover

story, “5S Shakeup“ (p. 18-24), talk more about the benefits that can be realized when

you reorder the steps of 5S: standardize, systematize, sort, shine and set in order.

• Back to Basics in Spanish Read the Spanish version of this month’s Back to Basics column, “Tell Me About It,“ (p.

80) in which author nicole M. Radziwill writes that by adding another step—export—to

the plan-do-study-act cycle, you can spark innovation.

www.qualityprogress.com

Online extras@

WANT THE LATEST QUALITY-RELATED NEWS AND ANALYSIS?The QNT Weekly e-newsletter delivers it every Friday.

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

Page 10: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

QP • www.qualityprogress.com8

Handling incoming inspectionsQ: How should we choose a sampling plan

for receiving inspection of parts that have

already gone through an inspection pro-

cess at our supplier’s facility before being

shipped to our facility?

Jared Christensen

Cedar Rapids, IA

A: This is an excellent question that every

facility should address. I have a number of

suggestions that you may find helpful.

My first suggestion is to determine

whether you have regulatory requirements

and factor those requirements into a docu-

mented plan. If you work in a regulated

industry, such as medical devices, phar-

maceuticals or aerospace, you may be re-

quired to inspect incoming material prior to

use, even if the material has already passed

a supplier inspection.1 Your facility also may

be bound by ISO standards to inspect—or

at least verify—the quality of incoming

material, and to hold the material until the

required testing has been completed and

appropriately documented.

Next, I recommend that you perform

a risk assessment. The concepts used in

failure mode and effects analysis (FMEA)

include a risk assessment based on three

factors: severity, occurrence and detection.

Within the context of receiving in-

spection, consider the impact of various

defects. Could the defect cause injury to

the final customer or will it merely cause

inconvenience with a potential loss of cus-

tomer confidence and satisfaction?

Occurrence is the frequency of the

defect within the population. At a mini-

mum, review your supplier history data,

if available, and rank the suppliers based

on the frequency of product returns and

in-process rejects that can be definitively

linked back to the supplier. The preferred

approach is to evaluate the supplier materi-

al versus each applicable specification. This

may require you to inspect and accumulate

data on an interim basis. Over time, you

will obtain enough information to make an

informed decision.

Finally, consider detection. Is the defect

hard to detect in subsequent processing

steps? If it is hard to detect, inspection

prior to use is more important. If the de-

fect is easy to detect, it is unlikely that the

defect will escape to the final customer,

so incoming inspection is less important.

Assign a rank scale to each of these three

factors, and multiply them together to

obtain a risk priority number (RPN). In

general, material with a high RPN number

should be subject to incoming inspection

for every lot or shipment, whereas mate-

rial with a low RPN can be subjected to

periodic inspections, but no less than once

per year.

The FMEA approach can be time

consuming. As an alternative, ask the

supplier for the raw data in addition to the

certificate of acceptance. Obtain data for

at least three of the supplier’s production

lots. More is better, but data for 10 lots are

sufficient for this purpose. Ask a quality

engineer or statistician within your orga-

nization to evaluate the supplier’s process

capability using a Cpk metric or similar

indicator. Products with high Cpk values (>

1.67) have low risk, so incoming inspection

may not be needed. Products that have

low Cpk values (< 1.33) should be inspected

more frequently.

Keep in mind that a few suppliers may

cherry pick the samples prior to inspection.

Samples with obvious defects are discard-

ed and are never included in the accep-

tance sample. The supplier may not realize

that this practice results in biased, mislead-

ing information. As your inspection system

matures, you can replace the supplier data

with your in-house inspection results and

gain confidence in your decisions.

I suggest that you compare your in-

house data to the supplier information at

least once per year. Use a two sample t-

test to see if there is a difference between

the two data sets. If the difference is

statistically significant, this is a red flag that

demands an explanation and may warrant

intensified inspection of future shipments.

As for the sampling plan itself, I suggest

using American National Standards Institute

(ANSI)/ASQ Z1.4 for attribute inspection and

ANSI/ASQ Z1.9 for variables inspection.2,3

The ANSI plans include tables with sample

sizes geared to the quality level that is de-

sired. The attribute plan includes switching

rules for deciding when inspection should

be tightened or reduced.

Incoming inspection costs money but

does not increase the value of the material.

You may have regulatory requirements that

compel you to inspect, but if you follow

some of the suggestions outlined above,

you can prioritize the inspection activities

and achieve a high level of quality assur-

ance at a minimum cost.

Andy Barnett

Consultant and Master Black Belt

Houston

RefeRences and note1. For medical devices, see Code of Federal Regulations

(CFR) Section 820.80. For pharmaceuticals, see CFR Sec-tion 211.84.

2. American National Standards Institute and ASQ, ANSI/ASQ Z1.4:2008—Sampling procedures and tables for inspection by attributes.

3. American National Standards Institute and ASQ, ANSI/ASQ Z1.9:2008—Sampling procedures and tables for inspection by variables for percent nonconforming.

foR moRe infoRmationBorror, Connie M., The Certified Quality Engineer Handbook,

third edition, ASQ Quality Press, 2009.

ExPERTANSWE RS

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October 2013 • QP 9

What’s so special?Q: How do you identify special processes

during a quality management system (QMS)

or process audit? What details should you

look for in these processes during the audit?

A: Validation of processes for production

and service provision is an ISO 9001:2008

requirement that is often overlooked by

organizations and not well understood by

some internal and external quality auditors.

I have seen organizations exclude this

from their QMS when applying Clause 1.2—

Application of the ISO 9001 standard. Sub-

sequently, during the audit I notice that the

organization, in fact, has special processes.

Internal and external auditors often have

failed to recognize this gap as well.

The standard stopped using the term

“special process” beginning in the ISO

9001:2000 version. But it has stuck in most

QMS practitioners’ minds. The standard

states: “The organization shall validate any

processes for production and service provi-

sion where the resulting output cannot be

verified by subsequent monitoring or mea-

surement and, as a consequence, deficien-

cies become apparent only after the product

is in use or the service has been delivered.”1

Those who work in manufacturing likely

know a list of processes that require valida-

tion. Examples include welding, soldering,

brazing, molding, painting and laminating.

The resulting output cannot be partially or

fully verified by a subsequent monitoring

and measurement step. Deficiencies (for ex-

ample, cracks, peeling and corrosion) show

up as defects after the product is in use.

Service processes are no different. There

are some service processes in which the re-

sulting output cannot be verified by subse-

quent monitoring or measurement. Examples

are physician consultation and online travel/

hotel booking. Physicians’ advice on medi-

cation cannot be verified unless the patient

reports the progress or any side effects.

Online services may offer several features,

and only when the guest avail the services do

deficiencies become apparent.

These products and services require

validation to ensure they can deliver the

planned results. Validation as defined by

ISO 9000:2005, item 3.8.5 as “confirmation,

through the provision of objective evidence,

that the requirements for a specific intend-

ed use or application have been fulfilled.”2

Items to verifyNow that we understand that the resulting

output for these processes cannot be verified

subsequently, we can get back to basics and

understand what constitutes this process. The

organization may have validated the welding

or soldering process by non-destructive and

destructive testing. The organization may

have cut cross sections to verify penetration

and conducted tests on weld break strength.

The weld may have been subjected to envi-

ronmental testing, shock and vibration.

Although the organization may still

continue to do destructive tests in a sample

quantity for every batch, it still must depend

on the initial validation. The process vari-

ables, including the operator, equipment,

material and operating environment that

achieved the planned results (output) should

be monitored. The auditors should verify:

• If there are defined criteria for review

and approval of the process.

• If the criteria align with initial validation.

• How the organization approves equipment.

• Qualification of personnel.

• Documentation of procedures used.

• Applicable records.

• Revalidation of the process as a periodic

disciplined approach and during any

changes to the process.

Process engineers conduct experiments

and establish process windows for critical

equipment and process parameters. As long

as the operations are conducted within that

window, no revalidation is required. If changes

are made—the equipment or process param-

eters are modified for cycle time reduction,

or materials are changed for cost saving, for

example—revalidation is required. For a ser-

vice process that requires validation, training,

competency and skill play a major role.

A process audit is more suitable for these

processes because the auditor has an op-

portunity to go deeper. The auditor must do

additional planning when a manufacturing or

service flow encompasses a special process.

Planning may include a process expert in the

audit team for guidance, creating a process-

specific audit checklist and researching histor-

ical issues traceable to the process. During the

audit, it is important to verify that the auditee

(internal) or your supplier understands and

recognizes the need for validating a process.

Govind Ramu

Director, quality assurance

SunPower Corp., San Jose, CA

RefeRences1. American National Standards Institute, International

Organization for Standardization and ASQ, ANSI/ISO/ASQ Q9001:2008—Quality management systems—Requirements.

2. American National Standards Institute, International Organization for Standardization and ASQ, ANSI/ISO/ASQ Q9000:2005—Quality management systems—Fundamen-tals and vocabulary.

BiBliogRaphyBrecken, Don, “Identifying Special Processes,” The Auditor,

November-December 2009.

ExPERTANSWE RS

asked and answeRedHave a quality-related question? Submit it at www.qualityprogress.com, or send it to [email protected], and our subject matter experts will help you find a solution.

Page 12: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

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Page 13: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

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Page 14: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

12

PERSPECTIVES BY CindY P. Veenstra and Glenn Walters

Action RequiredGrow STEM opportunities through active industry involvement

IN ITS EFFORT to advance ideas, research

and practice in science, technology,

engineering and mathematics (STEM)

education and workforce, ASQ’s Education

Division co-sponsored the third annual

Advancing the STEM Agenda Conference

in June.

The conference theme—collaboration

with industry—grew out of the success of

our 2012 STEM Agenda Conference panel

keynote led by Paul D. Plotkowski, dean of

the Seymour and Esther Padnos College of

Engineering and Computing at Grand Valley

State University in Michigan.

While we were pleased with the success

of the conference, more ASQ members

from industry could have attended and

learned about the STEM agenda and how

their companies can reach out to schools

and universities in their communities

through successful collaborations. Our

conclusion is that there is insufficient

awareness in the ASQ community of the

need for industry’s involvement in support-

ing the STEM agenda.

As ASQ members, we must do more

than work on getting certified and provid-

ing quality products to our customers;

we must actively support our education

system from which future employees come,

and recognize that we definitely can help

improve education through our profession-

al knowledge of continuous improvement

and our personal volunteer efforts.

We have a projected serious short-

age of STEM professionals, and the ASQ

community must get involved with STEM

education activities in their communities

to ensure we are developing the knowledge

and skill sets needed.

STEM shortfall in the U.S.Here are some STEM education facts:

• If the United States continues with the

same STEM graduation rates in our col-

leges and universities, we should expect

a shortage of 1 million STEM graduates

in the next 10 years.1

• Some organizations already are having

difficulty recruiting technicians, scientists

and engineers, even though we are recov-

ering from the worldwide recession.

• We will need more quality engineers and

professionals in the worldwide quality

workforce as the quality effort mirrors

the increase in the STEM workforce. Qual-

ity engineering and advanced

manufacturing are included in

STEM fields.

• Science and engineering are

seen as the basis for technical

innovation, which improves

economic global competitive-

ness. While the percentage of

natural science and engineer-

ing degrees has remained the

same in the United States

during the past 10 years, other

countries have developed

education policies to increase

the percentage and the number of STEM

graduates entering the STEM work-

force.2 The situation is so critical that

industry is asking for more international

graduates to be allowed to live in the

United States and work. Legislation in

the U.S. Congress would increase the

official quota of H1-B visas for highly

skilled foreign workers from the current

65,000 to 110,000.3

• U.S. high school students ranked 25th

in the world in their math knowledge.

Other STEM education facts are pre-

sented in the ASQ Education Division’s

Advancing the STEM Agenda: Quality

Improvement Supports STEM.4

Break down silos STEM education has many stakehold-

ers. Often in practice, we have looked at

K-12, higher education and the transition

to STEM careers as separate silos. At this

year’s conference, Reginald McGregor,

manager at Rolls-Royce Corp., led a key-

note discussion on the need to bring these

silos together, to talk more with one an-

other, and to understand the other sectors’

business and customer-focused challenges.

K-12 education has the challenge of

students not being college-ready. Higher

education has the challenge of low gradu-

ation rates. Industry has the challenge of

trying to find qualified employees. Because

industry is at the end of the STEM pipeline,

it has the most to gain through collabora-

tion with education.

Industry’s role should be to inspire,

mentor and integrate industry quality

practices with education. The President’s

Council of Advisors on Science and Tech-

nology “Engage to Excel” report encour-

aged us to inspire and prepare students for

QP • www.qualityprogress.com

STEM conversion / fIguRE 1

Academic progression to STEM degree

Industry support of STEM education

Middle/highschool

Middle/highschool

outreach

Co-ops/internships

Capstones

College

STEM = science, technology, engineering and mathematics

Page 15: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

October 2013 • QP 13

STEM careers.5 Both are needed through-

out the education pipeline. Many teach-

ers and faculty members have innovative

programs, but they need industry’s support

to provide excitement and inspiration, and

continuous improvement guidance for an

integrated approach to collaboration.

Quality professionals from industry

must bring the knowledge of process

improvement, lean Six Sigma and Baldrige

systems thinking to the STEM conversa-

tion on inspiring and preparing students

for STEM careers. Figure 1 suggests that

industry’s role through K-12 outreach, co-

ops and internships, and capstone projects

is a process of support to develop the next

generation of STEM innovators and work-

ers in our communities.

1. Middle school/high school out-

reach. In inspiring middle school and high

school students, we can look at industry’s

K-12 outreach efforts such as the For

Inspiration and Recognition of Science and

Technology (FIRST) robotics competition.6

We also can look at collaborative efforts

of inviting students to a research center,

sponsoring a career day or participating in

classrooms as Ford Motor Co. or Raytheon

Corp. explained in presentations at this

year’s conference.7,8 For example, Raytheon

employees involved with the Leadership

And Science Ensures Results (LASER)

program have touched and inspired 6,500

students in their science classrooms in the

past three years. Students will remember

these STEM professionals as role models as

they consider their college and career paths.

2. Co-op experiences/internships:

While in college, students who participate

in co-ops or internships see the excitement

of engineering projects and how they can

make a difference in the engineering world

through hands-on experience with a quality

engineering project, an engineering design

or even NASA space science research.

In providing a co-op/ internship, a

company is partnering with a university to

mentor a student in the ways of engineer-

ing practice or science research. Research

shows that the transition from student

to co-op/intern to a STEM career can be

viewed as a socialization process.9 The

experience then becomes a win-win rela-

tionship: a rewarding learning experience

for the student and a rewarding mentor-

ing experience for the company. Often

as graduates, these same students start

their STEM careers at the company that

provided the co-op/internship.

To reduce the high dropout rate of initial

STEM students in college, more summer co-

ops/internships could encourage students

to stay in a STEM field and help reduce the

high cost of college. If your company can

provide more co-ops/internships, consider

collaborating with a university.

3. Capstone experiences. Many STEM

programs have a semester or year-long

capstone project to finish a successful stu-

dent career and to aid in the transition to a

quality engineering or science career. These

are important semesters that integrate the

curriculum with the 21st century workforce

skills such as teamwork, critical thinking

and communication.10 Industry-sponsored

capstone projects provide a significant qual-

ity learning experience to graduates as they

transition to the STEM workforce.

Make a differenceThe STEM education movement is about

inspiring and educating students in science

and engineering careers. Research sug-

gests that we need a continuum of activi-

ties that first excite students about a STEM

career and encourage them through co-ops

and internship experiences.

The United States has a severe short-

age of STEM professionals. We encourage

you to talk with your organizations about

their STEM agendas and to reach out to

local school systems and universities in

the community, to participate in the FIRST

competition, to support career days and

especially, to provide more internship

experiences and co-op sponsorships.

We have STEM majors who cannot find

summer jobs in their fields. College tuition

is expensive. We have 80,000 ASQ mem-

bers. Suppose most of us encouraged our

organizations to sponsor just one intern-

ship per ASQ member. What a difference it

would make! QP

REFERENCES AND NOTE1. executive Office of the President, President’s Council of ad-

visors on science and technology, “report to the President: engage to excel: Producing One Million additional College Graduates With degrees in science, technology, engineer-ing and Mathematics,” February 2012.

2. national science Board, “science and engineering indica-tors 2012”, nsF, appendix tables 2-18 and 2-32, 2012, www.nsf.gov/statistics/seind12/appendix.htm.

3. Patrick temple-West, “immigration Bill increases Visas for skilled Workers, tightens rules,” reuters, april 16, 2013.

4. Cindy P. Veenstra, “introduction,” which appeared in Cindy P. Veenstra, Fernando F. Padró and Julie a. Furst-Bowe, eds., Advancing the STEM Agenda: Quality Improvement Supports STEM, asQ Quality Press, 2012. the book is an asQ resource to understand the major concern over the statistical facts that are often presented in the press on steM education. the book is available at http://asq.org/quality-press/display-item/?item=H1429, and its first chapter is open access.

5. executive Office of the President, President’s Council of ad-visors on science and technology, “report to the President: engage to excel: Producing One Million additional College Graduates with degrees in science, technology, engineer-ing and Mathematics,” see reference 1.

6. For inspiration and recognition of science and technology, www.usfirst.org.

7. imad H. Makki, “Promoting steM education through the Ford High school science & technology Program,” Proceedings of the 2013 asQ advancing the steM agenda Conference, Grand rapids, Mi.

8. Jill Brooks, “laser: leadership and science ensures results—evolution of a steM Partnership Between industry and education,” Proceedings of the 2013 asQ advancing the steM agenda Conference, Grand rapids, Mi.

9. Chris Plouff and James e. Barott, “a socialization Model for entry of engineering students into the Workplace through a Co-op Program,” which appeared in Cindy P. Veenstra, Fernando F. Padró and Julie a. Furst-Bowe, eds., Advancing the STEM Agenda: Quality Improvement Supports STEM, asQ Quality Press, 2012.

10. Paul d. Plotkowski, “Guest Commentary: real-World engi-neering education: the role of Continuous improvement,” Quality Approaches in Higher Education, asQ education division, May 2013, Vol. 4, no. 1, pp. 2-4.

GLENN WALTERS is the deputy cabinet secretary for the New Mexico Higher Education Department and was a keynote speaker for the 2013 Advanc-ing the STEM Agenda Conference. He has served as the ASQ Education Division workforce development chair and chair for the ASQ Team and Work-

place Excellence Forum.

CINDY P. VEENSTRA is principal consultant for Veenstra and Associates and was the conference co-chair for the 2013 Advancing the STEM Agenda conference. She is the immediate past chair of the ASQ Education Division and an ASQ fellow. She is a co-editor of advancing the steM agenda: Qual-

ity improvement supports steM (ASQ Quality Press, 2012).

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C

QP • www.qualityprogress.com14

food safety

Fowl-Up?Decision to allow some Chinese-processed poultry into U.S. raises concerns

keePingcurre ntconsumer safety advocates think u.s. regu-

lators might be setting the table for future

contamination outbreaks following a recent

ease in restrictions covering some chinese

poultry processors.

Last month, the u.s. department of agri-

culture (usda) began allowing four process-

ing plants in china to ship a limited amount of

poultry to the united states. the birds would

be raised and slaughtered in the united

states, canada or chile (the only countries

approved by the usda), but processed in chi-

na and sold back into the american market.

some think this development will eventu-

ally expand the rules—as soon as a year

from now—so chickens and turkeys actually

bred in china could end up in u.s. grocery

cases and restaurants.

“this is the first step toward allowing

china to export its own domestic chickens

to the u.s.” said tony corbo, the senior lob-

byist for food and Water Watch, an advo-

cacy group that promotes food safety.

the chinese facilities will verify that

cooked products exported to the united

states came from american birds, so no

usda inspector will be present in the plants.

Because the poultry will only be processed

there, it will not require a “Made in china”

label. that means u.s. consumers eating

frozen chicken nuggets from a grocery store

or a chicken sandwich from a fast-food res-

taurant will not know whether the chicken

came from a chinese processing plant.

Because of china’s recent history with

food safety lapses, nervousness about this

regulatory move is not surprising. the coun-

try has had frequent outbreaks of the deadly

avian influenza. recently, the u.s. food

and drug administration tied the deaths of

more than 500 dogs and a handful of cats to

chicken jerky treats that came from china.

the food was eventually recalled, but not

before it sickened another 2,500 animals.

“Previous usda poultry inspections

revealed conditions in china that could put

american consumers at risk,” rep. rosa de-

Lauro (d-conn.), one of the most vocal critics

of allowing chinese chicken in the united

states, said in a statement. “even if a one-off

visit shows an improved environment, there

will be no u.s. inspector continually present

when chicken is being processed for export

to the u.s. i continue to remain deeply con-

cerned that trade interests will trump public

health at the end of this process.”

usda officials defended the approvals,

saying the chinese processors provided

sufficient evidence and met the proper

requirements.

al almanza, administrator of the usda’s

food safety and inspection service (fsis),

said the four processing plants were audited

and cleared by inspectors earlier this year to

process u.s.-origin chicken and sell it back

into the american market.

during the March audit, the fsis sought

to determine whether the chinese govern-

ment provides sufficient, consistent over-

sight at poultry plants. the fsis also created

mock situations to test the plant personnel

and quizzed supervisors to see whether they

were now properly trained on the reformed

hazard analysis and critical control points

(HaccP), how to test for salmonella and lis-

teria, and what to do in the case of contami-

nation. By the end of the inspection, china

was given the green light to certify the four

poultry plants that will export processed

poultry to the united states.

“if we were to determine that their

system is equivalent [to u.s. plants], why

wouldn’t it be?” almanza said. “it’s the same

[set of standards] we use for any other coun-

try. We’re not treating china any differently

in determining equivalency for exporting to

the united states.”

Processed poultry is currently imported to

the united states from five other countries:

canada, chile, france, israel and Mexico.

almanza acknowledged more must be

done before the usda approves china for

exporting its own chicken. “there are some

issues that still need to be addressed” to es-

tablish equivalency between poultry plants

in the united states and china, he said.

an fsis spokeswoman said imported raw

poultry is audited through a different audit

team, and is not related to the auditing of

processed chicken.

BIBLIOGRAPHYElliot, Danielle, “Officials Say ‘Okay’ to Processed Chicken

From China,” CBS News, Sept. 6, 2013, www.cbsnews.com/8301-205_162-57601738/officials-say-okay-to- processed-chicken-from-china.

Parti, Tarini, and Bill Tomson, “Chinese-raised Chicken Could Be on U.S. Tables Soon,” Politico, Sept. 9, 2013, www.politico.com/story/2013/09/chinese-raised-chicken-96490.html.

Strom, Stephanie, “Chinese Chicken Processors Are Cleared to Ship to U.S.,” New York Times, Aug. 30, 2013, www.nytimes.com/2013/08/31/business/chinese-chicken-processors-are-cleared-to-ship-to-us.html?_r=0.

Tomson, Bill, and Tarini Parti, “USDA Trip Moves U.S. Closer to Accepting Chinese Chicken,” Politico, Aug. 15, 2013, www.politico.com/story/2013/08/usda-chinese-chicken-95586.html.

Page 17: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

october 2013 • QP 15

keePingcurre ntNAME: teresa L. Pratt.

RESIDENCE: atlanta.

EDUCATION: MBa from youngstown state university in

youngstown, ohio.

CURRENT JOB: corporate quality direc-

tor at Verizon telematics in atlanta,

responsible for overall product quality,

creating the infrastructure for the busi-

ness management system (total busi-

ness system vs. quality management

system), and teaching and managing

the internal auditing program.

INTRODUCTION TO QUALITY: When Pratt worked in inside

sales at a metal stamping company, she spent some time

with the stamping operators so she could learn how they

produced a quality product. this helped her better serve

customers. Later, she visited the quality department to see

how it tested products. as a salesperson, these experienc-

es were valuable because she could understand the needs

of customers beyond receiving their orders.

PREVIOUS EXPERIENCE: Her work at Plexus international

as a service provider and technical reviewer allowed her

to share with and learn from hundreds of quality profes-

sionals; delphi corp. and the automotive industry gave

her many lessons about iso/ts16949, six sigma and lean

enterprise.

ASQ ACTIVITIES: Pratt has been a part of asQ automotive

division for many years and is the former chair of Automo-

tive Excellence magazine.

RECENT AWARDS: Pratt was included in the 2012 class of

asQ fellows.

PERSONAL: Married and has two dogs.

FAVORITE WAY TO RELAX: Watching crime investigation

tV shows.

QUALITY QUOTE: Quality begins with a methodical

thought process and ends with an effective enterprise

solution.

Q Who’s Who insmaller organizations tend to be more open with customers regard-

ing the quality of their products and services than larger organiza-

tions are, and most quality professionals who hold senior positions

report directly to their ceos.

these are just a couple results from the second installment of

asQ’s global state of Quality research, which was released last

month. specifically, the “analysis, trends and opportunities 2013”

report revealed:

• of organizations with annual revenues of less than $100 million,

85% work closely with customers to understand the performance

of their products compared with just 72.6% of organizations with

revenues of more than $10 billion.

• nearly 75% of organizations with annual revenues of less than

$100 million share service or product quality performance data

with customers, while only 60% of organizations with more than

$10 billion in revenue share do so. according to the data, 67.3%

of all respondents share product or service quality with their cus-

tomers.

• nearly 75% of all organizations surveyed said their senior quality

position reports directly to the ceo or equivalent.

• about 46% of manufacturing organizations report quality mea-

sures to frontline staff daily, while almost 17% of service orga-

nizations report quality measures to frontline staff at the same

frequency. nearly 23% of services organizations share no quality

measures with frontline staff, compared

with less than 5% of manufacturing

organizations.

asQ partnered with the american

Productivity and Quality center to

conduct and manage the research and

reports. the first report, “discoveries

2013,” was unveiled at asQ’s World

conference on Quality and improve-

ment in May. a third report, titled

“insights, case study reports and con-

tinuing conversations,” will be released

later this year.

asQ will release a series of “spotlight” reports beginning this

month that will provide details and context from industry leaders

on specific topics, including the role of the customer in the quality

process, the culture of quality, and training and competencies. the

reports are based on data collected from 1,991 organizations in 22

countries.

asQ gLoBaL state of QuaLity researcH

SMALLER ORgANIzATIONSCLOSER TO ThEIR CUSTOMERS

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QP • www.qualityprogress.com16

keePingcurrent

asQ ceo Paul Borawski has announced plans to retire in May

2014.

“i was proud of the organization i joined (in 1986), and proud

of the organization asQ has become,” Borawski said in his

announcement. “asQ’s mission and vision have provided for a

career of immense inspiration and satisfaction.”

asQ’s executive council is developing a

hiring strategy that will include an external

search firm, said John timmerman, chair of

asQ’s board of directors. Borawski also will

play an active role in the selection of a new

ceo.

“Paul is committed to the success of

asQ and continuity of a ceo succession

process,” timmerman said. “Paul’s de-

parture is much more than a retirement

because he has imprinted a legacy and was the chief architect in

the growth of asQ.”

Borawski joined asQ in 1986 as director of technical activi-

ties and served as executive director, executive director and

chief strategic officer, and ceo. He will continue in his role as

ceo through the organization’s World conference on Quality and

improvement, May 5-7, 2014, in dallas.

Borawski said he hopes to spend time with friends and family

and to “enjoy several long-postponed adventures” during retire-

ment.

asQ

BORAWSkI, ASQ CEO, ANNOUNCES RETIREMENT

Manufacturing

SURVEY SAYS MORE MANUFACTURINg WORkERS UPBEAT ON JOB PROSPECTSMore than 40% of manufacturing workers said they will look

for a new job in the next 12 months, according to the randstad

Manufacturing employee confidence index released last month.

the quarterly measure of overall confidence among manufactur-

ing workers increased 0.9 points to 51.9 in the second quarter of

2013.

the number of manufacturing workers who said they believe

more jobs are available rose seven percentage points—increas-

ing from 21 to 28% in the second quarter. yet, fewer employees

are confident about the future of their current employers. in fact,

this was the sole area in which a decline (47% down from 53%)

among manufacturing employees occurred between the first and

second quarters of 2013.

“this quarter’s report underscores that manufacturing work-

ers have a real sense of optimism about the number of career

opportunities that exist today,” said Phyllis finley, executive vice

president at randstad u.s. “in fact, figures this high have not been

reported since well before the 2008 recession, and we believe

this increase has a correlation to employees’ confidence in the

overall economic recovery.”

for more details from the survey, visit www.randstadusa.com/

workforce360/jobs-the-economy/manufacturing-employees-

confident-and-on-the-move/123.

sHORtRunsThREE hUNDRED SChOLARShIPS to

help Marine veterans, reservists, active

duty personnel and their family members

become certified lean six sigma Black

Belts are being awarded by Leatherneck.

com, an online resource for former

Marines. Mikel Harry, a six sigma pioneer

and the board chair and president of the

six sigma Management institute, has do-

nated the scholarships. for more details,

visit www.leatherneck.com.

ThE AMERICAN SOCIETY for nonde-

structive testing will host its annual

conference nov. 4-7 in Las Vegas. the

event provides a forum for exchanging

theoretical, scientific and application

information and to learn about develop-

ments in nondestructive testing technol-

ogy. for more information, visit http://

tinyurl.com/otjmgfb.

ThE AMERICAN PRODUCTIVITY and

Quality center’s process conference will

be held oct. 21-25 in Houston. for more

information, visit www.apqc.org/

apqcs-2013-process-conference.

NEW MEMBERS WERE recently ap-

pointed to the board of overseers of

the Baldrige Performance excellence

Program. robert Hagans, Warren Harris,

terry Holliday and Liza nickerson seltzer

were named to three-year terms on the

board, and rulon stacey was appointed

board chair. the appointments were

made by the secretary of commerce to

advise the department of commerce on

the Baldrige program.

ThE NATIONAL PATIENT safety founda-

tion has named tejal k. gandhi, M.d., as

president of the nonprofit research and

education organization. gandhi is chief

quality and safety officer at Partners

Healthcare in Boston. for more informa-

tion about her background, visit http://

tinyurl.com/oalk29z.

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17

keePingcurrent

AsQnEWsNEW ENTERPRISE MEMBERS Microsoft,

Pepsico and abbVie, a research-based

biopharmaceutical company, have

become asQ latest enterprise mem-

bers, joining 46 other organizations at

this membership level. Visit http://asq.

org/membership/organizations/current-

members.html for more information about

enterprise membership.

SChOLARShIP AWARDED asQ has

awarded its richard a.

freund international

scholarship to kaibo

Liu, a georgia institute

of technology student

working toward a

doctoral degree in industrial engineering.

Liu, of china, was awarded the $5,000

scholarship, which is named after a past

asQ president and supports a quality

professional’s graduate studies.

AWARD RECIPIENT NAMED david

devoe, operations manager and general

manager of Plymouth spring co. in Bristol,

ct, has received asQ Hartford section’s

annual Quality recognition award for his

helping to establish Plymouth spring’s

lean program. for more information, visit

www.asqhartford.org.

Mr. Pareto head BY MIKE CROSSEN

BYThENUMBERSthe number of award recipients recently honored by the

american statistical association at its joint statistical meetings

in Montréal. awards and recipients included:

• Samuel S. Wilks Memorial Award: kanti Mardia.

• gottfried E. Noether Award: yingying fan and Jayaram

sethuraman.

• Outstanding Statistical Application Award: robert e. kass, ryan c. kelly and Wei-

Liem Loh.

• Edward C. Bryant Scholarship Trust Fund Award: natalie exner.

• W.J. Dixon Award for Excellence in Statistical Consulting: ronald d. snee.

• Waller Education Award: nathan tintle.

• W.J. Youden Award: Lane f. Burgette and Jerome reiter.

• Statistics in Chemistry Award: Peter goos and steven g. gilmour.

• karl E. Peace Award for Outstanding Statistical Contributions for the Better-ment of Society: richard Macey simon.

• Causality in Statistics Education Award: felix elwert.

for more about this year’s recipients, visit http://tinyurl.com/kztdwh7.

15

organizers of the fourth-annual World Quality Month, which takes place in november,

have issued a call for content to quality professionals around the world, asking them to

submit stories that illustrate the value of quality principles.

again this year, a special website dedicated to the month-long celebration will fea-

ture stories about the impact of quality on quality professionals’ lives or organizations.

the site, http://asq.org/world-quality-month, includes a tool kit to assist quality profes-

sionals in promoting awareness of this month, as well as ways to plan and promote

their own World Quality Month events.

the website, supported by asQ, also will feature videos and links to success stories

from individuals, companies and organizations around the world to share with col-

leagues. for more information about events, resources and other contributions, visit

the website or email the celebrations’ organizers at [email protected].

WorLd QuaLity MontH

gET READY TO CELEBRATE

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5S

Three secrets for sustaining 5S success

There are secreTs about 5S that

lean experts often overlook because nobody ever

clued them in. Before revealing the secrets, how-

ever, there are a few questions to answer: What is

5S? Why is 5S important to implement? And, why

do so many North American organizations fail in

5S implementation?

5S is a management technique that helps

organize a workplace by making it free of clut-

ter, more visual and safer. The S’s correlate to

Japanese terms that mean sort, shine, set in

In 50 Words Or Less • The key to sustaining

results gained through the 5S method is to begin by standardizing and systematizing, not sorting.

• By scoring early suc-cesses, you can build on employees’ desire to compete and find new areas to 5S.

• A manufacturer and one of its customers used the approach to improve its bottom line.

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SS

S

SS

order, standardize and systematize (or sustain). In

short, it’s cleaning up any work area and getting it

organized. It sounds so simple, and it appears very

obvious. Who could argue against the basic concept

of keeping your workplace orderly?

North American organizations frequently initiate

a 5S program and engage in a massive cleanup effort.

For many, they find the disorganization returns a few

months later. What a waste. The typical 5S effort that

falls on its face (see Figure 1, p. 20) generally follows

this pattern:

by John Casey

October 2013 • QP 19

LEAN

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QP • www.qualityprogress.com20

Leadership decides the plant is a mess and starts an

initiative to organize. The leaders appoint a champion

to take on the initiative for the organization, and that

person will passionately begin the process. The cham-

pion starts in a small pilot area and begins the process

by asking people to:

1. Sort what they need.

2. Shine up the work area by cleaning up the dirt.

3. Set things in order, or determine a logical place for

everything and put each item in its place.

At this point, the organization stops and celebrates

the feat a little because the area is obviously tidier. Of-

ten the organization skips the process of standardizing

and systematizing, and moves to another area. This is

where atrophy sets in.

After one area is completed, the champion moves to

the next, repeats the process and cleanup effort. With

all the noticeable improvement—plus the perception

of a better workplace—the organization gains some

momentum and the pace of activities begins to pick

up, allowing the 5S process to become a picture of suc-

cess.

At the end, the champion and leadership will feel

pretty good, and they’ll ask everyone to “Keep it this

way.” The workplace environment is obviously better

and safer. Why wouldn’t anyone want to sustain the

gains? But time passes and, eventually, gains are lost.

Then they ask themselves, “Why did the effort re-

vert back to the original state? Why did we do it in the

first place?” Certainly a clean shop makes people feel

better, but is that why management wants 5S?

secrets revealed5S increases profits because it exposes waste that can

be eliminated. The operations that win are the most

efficient in production, where the problems can be

seen and solved most quickly. When a strong 5S pro-

gram is in place, it is extremely easy for leaders to walk

around and see whether people are operating to the

plan and using the best practices. When everything is

in its place, a leader knows everyone has exactly what

he or she needs and has a baseline to start additional

continuous improvement projects.

Profit is the trigger for management. The secret is

that the 5S process, which, when properly implement-

ed, exposes waste, leading to increases in profitability.

This seems so obvious—why does the effort be-

come atrophic? When you look at the Japanese ap-

proach, they taught 5S in the sort, shine and set in

order sequence. What they didn’t realize is there is a

significant cultural difference between some Japanese

and North Americans.

In Japan, conformity is something to be treasured.

Many North Americans often do their own thing, and

conformity is not always cherished. To many Japanese,

excesses are unnatural. Many live in limited space.

They must store just what they want and need because

they don’t have enough space for excess. Many North

Americans are accustomed to wide open spaces. Some

people have so much extra that they must rent storage

facilities to house the items. They adopt a culture of

individualism and excess.

Because of this dichotomy, the North Americans

drifting back to their former comfort level explains

why atrophy occurs following 5S projects. Herein lies

the second secret: What some North Americans lack

is a self-imposed system of review—the fifth S, or sys-

tematize.

What is the system that many North Americans

like? It’s scoreboards. They want to win—it’s in their

culture. While they don’t really like to conform, they

naturally like to compete and beat the next person. 5S

doesn’t appeal to their basic motivations and inclina-

tions for friendly competition. The secret is that North

Americans must instead start concentrating on the sys-

tematic reinforcement within 5S to achieve the profits

that they are seeking.

Now for the third secret: Often, the 5S process

starts at the wrong step. North Americans must know

the standards and how they will be measured. An or-

The 5S cycle / figure 1

1. Sort

2. Shine

3. Set in order4. Standardize

5. Systematize

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October 2013 • QP 21

ganization should start with the standardization step

(see Figure 2). Management must start by defining the

standard (for example, the cleanliness specification).

Operators must know what is expected when stan-

dards are in place, and then the 5S process can start to

work. This is best done with a combination of words

and pictures.

The secret is to start at step four by defining your

standard and move to step five (systematize) by having

a process to systematically measure the orderliness.

Do these steps before you go to step one (sort). Try it,

and you’ll be surprised.

Disheveled and disorderlyThere was a problem at Standard Grinding and Manu-

facturing (SGM), a computer numerical control (CNC)

machining company in Skokie, IL, that produces preci-

sion and complex components for the aerospace, hy-

draulic and medical equipment industries. SGM’s ship-

ping area was a hub of constant activity with hundreds

of loads regularly coming and going.

With limited space, shipments and documents

were routinely misplaced. Workers always seemed

to be stepping over one another searching for mis-

placed boxes and paperwork. SGM had attempted 5S

in the past, but things always drifted back to a state

of mild disorder. The symptom was a cluttered ship-

ping area. The problem was sustaining the organiza-

tion at this work center.

One of SGM’s major customers is Honeywell Aero-

space, which deploys supplier development engineers

(SDE) who consult with its suppliers (such as SGM)

and works with them on continuous improvement

LEAN

The UnIqUe ApprOAch Of LeAn 5S AT SGMStandard grinding and Manufacturing (SgM) was hungry for a better way to implement lean 5S because previ-

ous attempts had stagnated. The following approach worked for SgM:

• SgM established a lean 5S internal audit team. Members of the original team were specifically chosen and

consisted of group leaders, supervisors and managers trained in lean 5S.

• The team visited a facility recognized as a lean 5S leader. employees at Honeywell Analytics in Lincolnshire,

iL, a Honeywell Operating Systems (HOS) silver-certification facility, recognized for its continuous improve-

ment efforts, helped the SgM team develop its long-range vision and objectives.

• SgM created a lean 5S company policy, or lean 5S mission statement, to unify and standardize the objective.

• SgM created its forms, checklists, questionnaires, metrics, policies and documents before the sort and shine

events. in other words, the internal audit team was first formed, and then standardize and systematize steps

were established.

• The internal audit team initially coached and educated employees. Scoring and metrics then became con-

tinually more stringent after the 5S expectations and culture had taken root.

• SgM encouraged a sixth S—safety—as opportunities arose.

• SgM encouraged continuous improvement and friendly competition within the company at every

opportunity. —J.C.

5S cycle secret to success / figure 2

3. Sort

4. Shine

5. Set in order1. Standardize

2. Systematize

Starthere

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QP • www.qualityprogress.com22

projects, especially lean Six Sigma.

During one visit, Honeywell’s SDE, Curtis Oswald,

was discussing shipping area orderliness with SGM’s

quality engineer, Donald Reynolds, and described how

most North American organizations start with sort,

shine and set in order. Because previous 5S projects did

not take root in the factory, Oswald and Reynolds de-

cided to launch another effort, but this time in a differ-

ent sequence: Begin with standardize and systematize.

When they proposed the concept to SGM General

Manager Howard Natal, the discussion centered on

cost. “Every time we tried this in the past, it always

felt like we were just spending money. I didn’t want to

throw money out the window again for a temporary

boost in housekeeping,” Natal said. “I wanted some-

thing that would stick.” Oswald and Reynolds’ idea was

different and had the permanence Natal was seeking.

They started by creating a layout of the shipping

area and went around the department and asked for

everyone’s input. This had a snowball effect. One idea

built on another, and they started to generate team ex-

citement: Everyone wanted to get started.

Next, Oswald and Reynolds took the key strategic

step. Before the 5S could start, they created a measure-

ment system, which included a scorecard, an internal

audit team and a weekly review schedule. With the

standard (the shipping area layout) and the system, the

team knew what to do and how it could define success.

SGM had even taken the step to create a bilingual 5S

mission statement (see “Lean 5S Mission Statement”).

LeAn 5S MISSIOn STATeMenT At Standard grinding Manufacturing (SgM), we are committed to lean 5S manufacturing for the benefit

not only of our customers but to our employees as well. The SgM team is actively involved in promoting

an environment of cleanliness, standardization, organization, improved efficiency, a better working envi-

ronment, teamwork, quality and safety.

En Standard Grinding Manufacturing, estamos comprometidos a inclinarse fabricación de 5S en benefi-

cio no sólo para nuestros clientes sino a nuestros empleados así. El equipo de SGM participa activamente

en la promoción de un entorno de: limpieza, normalización, organización, eficiencia mejorada, mejor

ambiente de trabajo, trabajo en equipo, calidad y seguridad.

The shIPPING area at standard Grinding and Manufacturing is the hub of constant activity as hundreds of incoming and outgoing shipments are processed daily at this station. The area before the 5s initiative (left) was cluttered and disorga-nized, overloaded with needless boxes and misused tables and shelving. Following the 5s exercise (right), more space was created to allow employees to function more efficiently.

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October 2013 • QP 23

“The 5S mission statement set the stage for the cul-

ture change at SGM. Everyone needed to be involved,”

Reynolds said. “Having a bilingual statement signals

that no one is excluded. Ownership of a lean 5S project

gives the workers pride and a sense of achievement.

They want to sustain what they’ve accomplished.”

When the sort, shine and set in order activity got

started, everything just flowed naturally. Decisions

became easy. “If we needed something, we had desig-

nated a place for it. If it didn’t have a place, the item

became a target for disposition,” Reynolds said.

“The sort and shine steps happened so naturally—

almost automatically—by this point. We found old

credenzas and lots of nonstandard sizes and heights of

tables. We took care of that and the flow of product is

way up,” Reynolds said. “The work is just easier. Safety

was a natural byproduct, too. We are seeing a 65% re-

duction in shipping errors and a much faster flow of

product. The standard and the system broke the pack-

rat syndrome, and SGM started disposing of things that

hadn’t been used for many years.”

See the sidebar, “The Unique Approach of Lean 5S

at SGM” (p. 21), for a breakdown of the specific steps

SGM took to implement the 5S method.

The work in the shipping area now is much easier.

The clutter is gone, and the group can handle the peak

congestion periods with relative ease. Because the

staff members created the system, became involved in

defining the standard and created a process in which

they self-measure, the sustainability is real. See photos

of the transformation above.

“This approach to 5S implementation greatly re-

duced the fear of change and of the unknown,” Oswald

said. “Teamwork and a winning attitude was the end

result. SGM did a great job. It was very rewarding.”

The best part is that people compete with one an-

other and try to set new records for orderliness and

simplicity. What’s remarkable is that the departments

are starting to compete with one another, including in

self-started initiatives in the maintenance department.

Now the team at SGM has a new problem: Which

area does it select for 5S next? QP

AcKnOWLeDGeMenTThe author thanks Curtis Oswald and Donald Reynolds for their input in crafting this article. Oswald is a senior supplier development engineer at Honeywell Aerospace and is based in Chicago. He holds a bachelor’s degree in mechanical engineering from the Illinois Institute of Technology in Chicago. Oswald is an ASQ member. Reynolds is a quality engineer at Standard Grinding and Manufacturing Co. in Skokie, IL. He holds a bachelor’s degree in mechanical engineering from the Illinois Institute of Technology. Reynolds is also an ASQ member.

LEAN

JOHN CASEY is a senior director of supplier perfor-mance management at Honeywell Aerospace in Tempe, AZ. He holds an MBA from the University of Michigan in Ann Arbor. Casey is an ASQ senior member and the past chair of the ASQ Automotive Division. He is the author of Strategic Error-Proofing (CRC Press, 2008).

IN The shIPPING area, seen from above before the 5s project (left), the scales were nearly lost in the clutter. after the 5s activities (right), workers dedicated a separate table to hold the scales. Workers are now better able to handle peak congestion periods, and the company has seen a 65% drop in shipping errors since the 5s changes took hold.

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For the Greater Good

Greater community concern about environ-

mental issues, including reducing waste, recycling, conserving water,

eliminating unnecessary chemical disposal and decreasing pollution, is

influencing attitudes of staff members at Sullivan Nicolaides Pathology

(SNP) about employer activities.

Australia’s droughts, increased water and power costs, and the debate

about the viability of coal-burning power plants are daily reminders of the

future environmental threats to living standards.

Individually, many staff members may be aware of the waste generated

in their daily work activities but feel powerless to reduce this waste.

A laboratory reduces waste, enhances efficiency and staff engagement with ISO 14001

by Tony Badrick, Sue Kehrer and Elizabeth Reid

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October 2013 • QP 25

social responsibility

In 50 Words Or Less • In 2006, the Coffs Harbour

Laboratory of Sullivan Nicolaides Pathology in Australia implemented an environmental manage-ment system, designed to expand on its existing qual-ity management system.

• After achieving ISO 14001:2004 certification in 2009, the laboratory realized financial savings through reduced waste and improved operational effi-ciencies, and saw increased staff engagement.

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QP • www.qualityprogress.com26

Many organizations have declared their commit-

ment to the environment by formally implementing

ISO 14001:2004—Environmental management sys-

tems—Requirements with guidance for use.1 But few

clinical laboratories have formally adopted ISO 14001,

even though they can be high polluters. Clinical labora-

tories use a high volume of a range of chemicals. They

have high water requirements for assays and infection

risk reduction, and consume a large amount of power.

So, it’s appropriate for clinical laboratories to become

environmentally responsible.

SNP is a large, private pathology organization com-

prising a central laboratory located in Brisbane, Aus-

tralia, with more than 20 satellite laboratories through-

out Queensland and northern New South Wales. The

organization is certified to ISO 15189,2 the standard

that specifies quality management system (QMS) re-

quirements for medical laboratories, and employs

about 2,000 full-time equivalent staff members.

Pathology organizations have many stakeholders,

including staff, contractors, patients, referrers and the

community. There are greater expectations today from

all of these groups about environmental awareness

and action. Often, it is only when there is an incident

that the community becomes aware of the hazardous

nature of an industry.

Programs and procedures

responsibility timeframe associated records Storage location and responsibility

retention time

Monitor plain paper usage

Assistant laboratory manager

3 monthly updates Use data from purchasing Refer supply department

Refer supply department

Plain paper use graphs Assistant laboratory manager

3 monthly updates Use graphs Staff noticeboard/intranet

12 months

Monitor printer and copier consumables use

Assistant laboratory manager

3 monthly updates Use data from purchasing Refer supply department

Refer supply department

Printer/copier consumables use

Assistant laboratory manager

3 monthly updates Use graphs Staff noticeboard/intranet

12 months

Report for corporate MRM

Toowong Sherwood Road environmental committee

6 monthly Meeting minutes Meridio 3 years

Train staff in EMS01 Practice environmental systems coordinator

As required Training attendance records

Assessment forms

Certificates

Meridio

Staff training file

Staff training file

Life of employment plus 3 years

Monitor energy use for 12 months

Assistant laboratory manager

To be completed for the whole of 2010

Outgoings for tenancy SNP accounts payable

7 years

Energy use graphs Assistant laboratory manager

3 monthly updates Use graphs (note: meeting and training events)

Staff noticeboard/intranet

12 months

Maintenance of air conditioning units

Building management

Refer to building management

Maintenance of split-system air conditioning units

Essential services Units currently under warranty

Paper records held by essential services

Essential services/facilities coordinator

12 months

Train staff in EMS01 Practice environmental systems coordinator

As required Training attendance records

Assessment forms

Certificates

Meridio

Staff training file

Staff training file

Life of employment plus 3 years

Examples of the targets and action plans used in the implementation process / TABLE 1

EMS01= Introduction to Environmental Management Systems internal training course

Meridio = electronic document and records management system

MRM= management review meeting

SNP = Sullivan Nicolaides Pathology

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October 2013 • QP 27

In 2006, SNP began working toward ISO 14001 envi-

ronmental management system (EMS) implementation

rather than just enacting an environmental manage-

ment policy. The organization wanted to be recognized

as a leader in environmental protection and it wanted

to reduce its environmental risks, improve community

relations and lower operating costs. In addition, be-

cause reducing waste is one of the fundamental tenets

of quality, the facility’s leadership saw a natural link

between environmental policy and the principles of

quality improvement.

Implementing ISO 14001 is a significant organiza-

tional exercise that can take years to achieve, although

having ISO 90013 in place was expected to significantly

reduce the time required.

Annex B of ISO 14001 identifies broad technical con-

nections between ISO 14001 and ISO 9001. The fact that

SNP already had an established quality management

system, combined with commonalities between the two

standards—for example, document and record control,

audit process, nonconformities, management review,

and application of the plan-do-check-act (PDCA) cycle

and continuous improvement concepts—aided the

implementation process. Achieving certification to ISO

9001 ensured SNP had addressed all requirements for

documentation and processes fundamental to an EMS.

A PDCA cycle comprising audits, management review,

the investigation of nonconformances and corrective ac-

tions was already a part of the organizational landscape

at SNP. It had a proactive workplace health and safety

system, and had implemented lean management, both

of which support environmental management with their

focus on risk management strategies, disaster mitigation

and reduction of resources, energy and waste.

The cost of implementing ISO 14001 varies depend-

ing on the pace of adoption, any external resources

needed, such as consultants, and the support of senior

management. The greatest challenge to any organiza-

tional change is the recognition by staff members of

the value of the change and the pace at which staff

members fully engage in the process of change.

In the past, ISO 14001 has been portrayed as an

expensive, resource-intensive endeavor, so SNP’s

aim was to demonstrate true financial and workflow

savings that were directly attributable to the imple-

mentation. The order and speed of implementation

were driven by the staff and managers at individual

sites as they perceived the benefits of the process.

Leaders were keen to assess any changes in staff at-

titudes to ISO 14001 as the implementation progressed.

PDCA cycle No. 1 / fIgURE 1 PDCA cycle No. 2 / fIgURE 2

Check:• Environmental cost of transport• Heavy financial cost ($130/10 liters)• Treated or just disposed of elsewhere?

Liquidwaste

treatment(1)

Plan:Develop

system totreat liquidstain waste

Do:Send to Brisbane waste contractor via road transport

for disposal

Act:Develop apparatus and procedure for

treating on site(example:

carbon column)

Liquidwaste

treatment(2)

Check:• pH balancing needed• Haematoxylin does not bind• 30 liters = ~$10

Do:Have carboncolumn made

to design

Plan:Design carbon

column fortreatmentof stains

Act:• Maintain records of pH check and balance• Separate disposal system for haematoxylin

PDCA = plan-do-check-act PDCA = plan-do-check-act

social responsibility

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QP • www.qualityprogress.com28

methodsInitial environmental reviews were carried out to de-

termine the impact SNP had on the environment. The

identification of practices that produced physical

waste or consumed measurable resources was funda-

mental to the audit. It was decided the scope would

include all sections—the laboratory, collection, couri-

ers and administration—at two laboratories located in

Coffs Harbour and Grafton.

The implementation itself was seen as a quality im-

provement exercise, and the PDCA cycle was used as a

model. An example of the process is shown in Figures

1 and 2 (p. 27), which detail the action plan to stop the

disposal of chemicals used to stain blood cells into the

sewerage system.

The initial aim was to stop discharging liquid chemical

waste into the sewerage system. When this was achieved

through transporting waste to Brisbane for disposal via a

licensed carrier, another cycle of implementing process

improvement resulted in treating the waste on site, re-

ducing financial and environmental impact.

To measure outcomes, various environmental as-

pects, such as power, water and waste, were moni-

tored for 12 months to obtain baseline data. Targets

were set, and the programs to meet the targets were

created (see Table 1, p. 26). Progress was monitored

via monthly reviews and audits. Where necessary, tar-

gets were revised or processes were altered as a part

of the check component of PDCA.

Prior to implementation, there was a full corporate

audit against ISO 14001 and a system review. Key to any

major change activity, staff members also were surveyed

to obtain baseline data on their attitudes about environ-

mental issues and the implementation of ISO 14001.

Staff training was vital to achieving success. Many

staff members were environmentally responsible at

home but felt overwhelmed by the volume of waste

generated in the workplace. They knew they were con-

tributing to creating waste in their daily work activi-

ties, so people were receptive when it came to imple-

menting an EMS. Training modules were developed for

staff and managers.

Green noticeboards were introduced into all labora-

tories to keep staff informed on progress of programs,

new initiatives and local environmental initiatives,

such as providing support to Landcare, a community-

based environmental movement in Australia.4

Contractors receive the same training as SNP em-

ployees, so they are aware of the importance SNP plac-

es on the environment and that they should also miti-

gate their environmental impact. Whenever possible,

contractors using environmentally friendly products

and processes are given precedence.

Presentations to stakeholders aim to educate the

public, patients, local government councils and focus

groups about SNP’s environmental responsibility, and

the benefits to the organization and communities. This

includes public display of SNP’s environmental policy

in all collection centers and laboratories, as well as on

its website.

initiatives and outcomesUsing ISO 14001 as a guide, SNP implemented several ini-

tiatives to help its facilities reduce environmental impact:

0

2

4

6

8

10

12

14

16

18

Jan. Feb. March April May June July Aug. Sept. Oct. Nov. Dec.

20082009

Per

cen

tage

0

100

200

300

400

500

600

700

800

1 2 3 4

kWh

d-1

Quarterly cycle

20092010

20112012

Percentage diversion of waste from landfill / fIgURE 3

Reduction in power use by Coffs Harbour Laboratory / fIgURE 4

kWhd-1 = kilowatt hours per day

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General recycling. In 2008, a

total of 297 cubic meters of waste

was recycled—an average of 25 cu-

bic meters per month. By 2009, this

had increased to a total of 492 cubic

meters of waste recycled, or an av-

erage of 41 cubic meters per month.

(see Figure 3). The total amount of

printer waste diverted from landfills

from July 2007 to March 2012 was

8.9 tons.

Xylene recycling. Through on-

site recycling of xylene, there is a

lesser risk of an environmentally sig-

nificant spill because less is stored,

and there is reduced environmental

impact from transport and disposal of the product.

There is also an associated financial savings from re-

duced disposal and purchase costs.

Energy consumption. A major focus of the ener-

gy conservation plan was to reduce power consump-

tion and stretch set targets. These targets could be

achieved by:

• Installing energy efficient lighting.

• Using natural light in building design, window tint-

ing and movement sensors.

• Enforcing policies to turn off lights and some equip-

ment after hours.

• Using energy-efficient versions of equipment such

as refrigerators and flat-screen monitors.

• Regularly maintaining and consolidating resources

for maintaining equipment such as refrigerators,

freezers and incubators.

• Removing obsolete or underused items.

Figure 4 shows the energy consumption of the

new Coffs Harbour site. The site was built using

smart lights, which respond to ambient light. The site

also maximizes use of natural light and window tint-

ing, which reduces heat.

Through ongoing review of equipment and process-

es, such as rebalancing the air conditioning system to

adjust for placement of new equipment, auditing pow-

er use by individual pieces of equipment and turning

down the light used on computer screens, it has been

possible to continue reducing power consumption.

Water consumption. The new laboratory site in

Coffs Harbour included a 30,000-liter underground

rainwater tank, which harvested water from the roof of

the building. This water is used to flush the dual flush

toilets and water the gardens, which are stocked with

drought-tolerant plants. Despite business growth, wa-

ter use has not increased (see Figure 5).

Staff survey results. In any management system,

outcomes must be measurable and measured so the

success of the actions can be learned. Staff engage-

ment was considered vital to the successful implemen-

tation of the EMS.

To measure the impact of educational programs and

communication, staff surveys were conducted in Coffs

Harbour and Grafton. The initial survey was conducted

at the time of certification, and a follow-up survey was

conducted 12 months later.

Overall, the staff surveys revealed the following

staff awareness and understanding after the EMS was

implemented:

• An increased awareness of SNP’s implementing an

EMS (Figure 6, p. 30).

• An increased understanding of what certification

means (Figure 7, p. 30).

• A better understanding of the benefits of an EMS

(Figure 8, p. 30).

• A better understanding of the requirements to main-

tain an EMS through continuous quality improve-

ments (Figure 9, p. 31).

Despite the improvement and the increased staff

engagement, the survey also indicated some staff mem-

bers still see an EMS as another layer of documentation,

rather than as a dynamic tool to improve their environ-

ment, work efficiency and quality of life. For this rea-

son, the EMS induction training is now presented with

October 2013 • QP 29

social responsibility

Coffs Harbour Laboratory water use after move to new site (October 2008) with tank water / fIgURE 5

0

1

2

3

4

5

Jan. April July Oct.

Ave

rage

dai

ly u

se (

kL)

Quarterly cycle

2003

2004

2005

2006

2007

2008

2009

2010

2011

kL = kiloliter

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QP • www.qualityprogress.com30

Improved awareness of EMS / fIgURE 6

Understanding certification / fIgURE 7

6%

44%

6% 0%

44%

What is ISO 14001?(2011)

6%

65% 0%

29%

What is ISO 14001?(2009)

Policy regarding environmentRequirements for an environmental management systemAccreditation body similar to the National Association of Testing AuthoritiesCorporate policy developed by executive committeeAll of the above

0% 94%

0% 6%

Have we achieved ISO 14001 certification?

(2011)

78%

0% 22%

Have we achieved ISO 14001 certification?

(2009)

Yes No In the process of attaining accreditation

EMS = environmental management system

the quality systems and safety induction training. The

complementary nature and interrelatedness of the im-

provement cycles are emphasized at this time.

The EMS is now in place, so environmental train-

ing for new staff incorporates a questionnaire to learn

whether the training module has increased awareness

of environmental issues and whether staff members

value environmental responsibility in an employer.

Because the survey is a recent addition to the EMS

induction training, there are insufficient results for sta-

tistical analyses. Preliminary results, however, indicate

that demonstrated environmental responsibility is val-

ued by staff, although it is not necessarily the deciding

factor for all staff when choosing an employer.

Benefits and paybackSNP undertook EMS implementation and ISO 14001

certification to introduce a structured approach for

identifying and managing legal obligations and its en-

vironmental impacts, and to meet key stakeholder as-

pirations.

The benefits of the established EMS to

the organization include:

• Improved environmental awareness

and performance.

• Cost savings, business efficiencies and

compliance with regulations.

• Improved corporate image and market-

ing opportunities.

• Reduced risk of disaster and improved

relationships with the public and com-

munity.

The EMS increases the accountabil-

ity of internal stakeholders (staff and

contractors) and external stakeholders

(patients, referrers and the community).

Importantly, it entrenches the concept of

Benefits of an EMS / fIgURE 8

5

0

10

15

20

25

30

Improvedenvironmentalperformance

Compliance withenvironmental

regulations

Costreduction

Improvedrelationshipswith public

and community

Demonstrationof superiority

to otherpathology

organizations

Nu

mb

er o

f re

spo

nse

s Expected results20092011

Actual results20092011

EMS = environmental management system

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October 2013 • QP 31

social responsibility

continual improvement in the minds of those stake-

holders.

Implementing an EMS has led to improved environ-

mental awareness and performance, better relation-

ships with the local community, environmental and

true cost savings, and a leaner and greener approach to

business. Since beginning the implementation process,

SNP has seen a cultural change, with environmental

management being at the forefront of many business

decisions.

In other industries, the payback period in terms of

the implementation cost for ISO 14001 has been estimat-

ed to be between 18 and 24 months.5 Determining the

payback period is difficult because some facility chang-

es, such as plumbing and power, occur opportunistically

and incrementally. The cost of implementation is based

on staff time spent on documentation and training and

obvious costs associated with the implementation.

The payback period in a clinical laboratory is esti-

mated to be two years with substantial ongoing sav-

ings, in addition to the intangible benefits of greater

environmental awareness and leadership.

While reducing waste is a component of any qual-

ity system, ISO 14001 effectively extends the scope of

reducing waste within a quality system so it is under-

stood by staff members and can be practiced not only

in their private lives, but also in the workplace. QP

REfERENCES AND NOtE1. international organization for standardization, ISO 14001:2004—Environ-

mental management systems—Requirements with guidance for use.2. international organization for standardization, ISO 15189:2007—Medical

laboratories—Particular requirements for quality and competence.3. international organization for standardization, ISO 9001:2008—Quality

management systems—Requirements. 4. landcare australia is a community-based movement that encourages

integrated management of environmental assets with productive farmland and a more sustainable approach to private land management. For more

information, visit www.landcareonline.com.au.5. Joe cascio and Gregory J. Hale, “iso 14000: a status

report,” Quality Digest, February 1998, www.quality digest.com/feb98/html/iso14000.html. Maintaining an EMS / fIgURE 9

To maintain ISO 14001,an organization

must: (2011)

To maintain ISO 14001,an organization

must: (2009)

0% 0%

5%

39%

56%

43%

43%

14%

Continue to follow protocols Continue to follow protocols and improve performancePass annual inspections from ISO 14001 assessors

Do nothingELIZABETH REID is a practice work-place health and safety trainer, and environmental systems coordina-tor for Sullivan Nicolaides Pathol-ogy. She has a bachelor’s degree in medical science from Queensland University of Technology. Reid is an RABQSA-registered lead auditor in

environmental and safety systems.

SUE KEHRER is the New South Wales Laboratory group manager for Sullivan Nicolaides Pathology in Coffs Harbour, Australia. She has a doctorate from the University of Technology, Sydney. Kehrer is RABQSA-EM-certified in environ-mental management systems.

TONY BADRICK is an associate professor at Bond University in Queensland, Australia. He has a doctorate in quality management from Queensland University of Technology in Brisbane. Badrick is a senior member of ASQ.

Demonstrated environmental responsibility is valued by staff, although it is not necessarily the deciding factor for all staff when choosing an employer.

EMS = environmental management system

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QP • www.qualityprogress.comxx

Quality can be defined in many ways. In techni-

cal usage, quality can have two meanings: the characteristics of

a product or service that influence its ability to satisfy stated or

implied needs; or a product or service free of deficiencies.1

In today’s marketplace, the meaning of a product or service

being able to satisfy the stated or implied needs goes well beyond

price, functionality or customer service.

In 50 Words Or Less • Consumers are more

environmentally and socially concerned about the products they buy and how organizations make them.

• Organizations realize energy efficiency, too, has become a highly coveted quality attribute.

• Quality professionals can contribute to these initiatives by collaborat-ing with energy manage-ment teams to improve an organization’s energy con-sumption and efficiency.

Quality can power up efforts in energy management and make a difference

by Natalia Scriabina and Gary Cort

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October 2013 • QP 33

ENERGY

by Natalia Scriabina and Gary Cort

Hollywood mom Jessica Alba, for example, recently cofound-

ed the Honest Co.2 as a resource for parents seeking healthy

and nontoxic products, including personal care items, cleaning

products and diapers for their families. Like many consumers

and parents, I pay more attention to the presence of potentially

hazardous substances in a product rather than just its package or

functionality.

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QP • www.qualityprogress.com34

I also wouldn’t buy a product if I knew it was made

using child or forced labor, or if its production caused

death or illness of workers, or it damaged the environ-

ment. I can quickly find an alternative product that

makes me feel better about my choices. I reduce, re-

use, recycle and do my best to save energy.

Am I a unique consumer? Absolutely not. The num-

ber of environmentally and socially concerned con-

sumers is growing rapidly in large part because envi-

ronmental and social regulation are becoming stronger

around the world.

In particular, energy savings has become a quality

attribute required to satisfy stated or implied customer

needs. Knowing the different aspects of energy effi-

ciency and what influences this quality attribute, and

understanding key principles of energy management

and its connections to quality will help quality pro-

fessionals contribute to these initiatives and make a

positive impact on the business sustainability of their

organizations.

Global energy efficiency in practiceThere are three major areas in which an organization

can achieve its goals for energy efficiency, and quality

can play a leading role in reaching these goals:

1. Energy efficiency of products. Spanish auto

manufacturer Seat exemplifies how one organization

has strongly committed to designing and building

products with energy efficiency in mind. Energy-effi-

cient LED lamps have become a standard feature of

Seat autos. Last year, Seat produced three new electric

car models as part of a corporate strategy of energy

conservation. The design of the new car models focus-

es on low-emissions driving, brake energy recovery,

improved aerodynamics and low-resistance tires.

These auto features have become important priori-

ties in public procurement by government institutions

and municipalities, and they also are becoming more

sought after by individual car buyers and businesses.

In July 2011, Seat became the first company in Spain

to conform to ISO 50001:2011—Energy management

systems (EnMS).3

More ways organizations look at the energy effi-

ciency of products include responding to the growing

demand for energy-saving features in battery-powered

portable electronic devices such as digital media play-

ers, digital cameras, cell phones, laptops, notebooks

and tablets. Customers want to optimize battery power

by enabling and disabling different device functional-

ities manually and automatically, and by receiving no-

tifications to disconnect the charger when charging is

complete. These features help prolong battery life and

minimize overall energy consumption.

More examples of the high demand for energy-sav-

ing features are found in products and services related

to lighting, heating, cooling and transportation.

2. Energy efficiency of operations. There are

many ways an organization can increase the energy effi-

ciency of its operations. Minor ways include better insu-

lating the structures, using energy-efficient light bulbs,

moving to cloud computing and hosting virtual online

meetings instead of requiring people to travel and meet

in person. Major improvements in energy efficiency also

can be achieved by deploying new equipment and tech-

nologies.

St. Mary’s Cement Inc., a cement producer based in

East York, Ontario, credits quality and its ISO 50001

certification for helping it find ways to become more

energy efficient. Since 2005, the company has reduced

electricity consumption by more than 11 million kilo-

watt hours per year, or about the same amount of en-

ergy used by 1,100 Canadian homes in one year. This

has translated into more than $3 million in yearly sav-

ings. “The energy conservation elements of ISO 50001

certification means we are on track for more than $1

million in savings in 2011,” according to the company.4

Bentley Motors, the British luxury automaker head-

quartered in Crewe, U.K., says it has pursued several

energy initiatives including “improved heating and

lighting, better controlled boiler and compressed air

systems, greater insulation and more efficient variable

speed drives.” As a result, “between 2000 and 2010, the

energy used on site for each car produced was reduced

by two-thirds and by 14% for the overall site. This has

delivered savings of 230 gigawatt hours of energy—

enough to power 11,500 houses for a year.”5

3. Decarbonization of energy supply. This global

trend has started to change how energy is produced

and consumed through an increasing number of clean

energy policies. These regulations either establish

prices for carbon emission (such as cap and trade pro-

grams) or provide incentives for the development and

use of renewable energy sources (such as feed-in tariff

programs). An organization can choose to use clean

energy to avoid possible high charges for carbon emis-

sions.

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October 2013 • QP 35

The Samsung Electronics North America Quality

Assurance Laboratory, for example, estimated 80% of

the annual power consumption at its facilities in North

America could be generated by using 1,800 solar pan-

els. Samsung Electronics in Korea plans to invest 20

trillion KRW ($360 billion) into green growth business-

es, such as solar cells, LED, fuel cells and geothermal

power, with affiliates within Samsung Group by 2020.”6

Coca-Cola Co., too, has undertaken similar initia-

tives and installed solar panels at its Edmonton, Alber-

ta, site and its Sidcup and Wakefield sites in the United

Kingdom.7

energy management using iSO 50001Quality professionals know one of the most effective

ways to manage quality is by implementing and main-

taining a quality management system. Similarly, one of

the most effective ways to manage energy efficiency

and consumption is by implementing and maintaining

an EnMS.

EnMS on a national level have been in place for al-

most a decade. Several associations around the world

have issued national standards that specify guidance,

recommendations and requirements for EnMS. These

organizations include:

• Swedish Standard Institute.

• Thai Industrial Standards Institute.

• National Standards Authority of Ireland.

• Korean Agency for Technology and Standards and

Korean Standards Association.

• American National Standards Institute.

• Standardization Administration of China.

In 2009, the European Committee for Standardiza-

tion issued European Standard EN 16001:2009—En-

ergy management systems, which replaced the equiva-

lent national standards of European Union member

countries. In 2011, the International Organization for

Standardization (ISO) issued EnMS, which replaced EN

16001:2009 and most equivalent national standards. To-

day, ISO 50001 is a global standard that represents inter-

national best practices in energy management.

ISO 50001 is applicable to any organization and can

be used for self-evaluation, self-declaration of confor-

mity or external certification. Also, ISO 50001 can be

integrated easily with other management systems such

as ISO 9001—Quality management systems or ISO

14001—Environmental management systems. In-

tegration is possible because ISO 50001 has a similar

structure and several generic processes common for

different management systems, including:

• Management commitment.

• Policy (energy, quality and environmental).

• Objectives.

• Planning.

• Responsibility and authority.

• Competence training and awareness.

• Control of documents and records.

• Purchasing.

• Measurement analysis and improvement.

• Management review.

• Corrective and preventive actions.

• Internal audits.

Figure 1 represents the EMS model as defined

by ISO 50001 and shows how it’s based on the plan

(planning)-do (implementation and operation)-check

(checking)-act (internal audit, management review and

continual improvement) cycle. As the figure shows, an

ENERGY

Energy management system model / fiGure 1

Continualimprovement

Energy policy

Planning

Implementationand operation

Monitoring andmeasurementChecking

Corrective andpreventive action

Managementreview

Internal audit

Source: international Organization for Standardization, ISO 50001:2011—Energy management systems

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QP • www.qualityprogress.com36

energy policy is the starting point and cornerstone of

any EMS.

Policy, management and sustainabilityISO 50001 defines an energy policy as: “Overall in-

tentions and direction of an organization related to

its energy performance as formally expressed by top

management. The energy policy provides a framework

for action and for the setting of energy objectives and

energy targets.”8

As described by ISO 50001, an energy policy should

establish a framework for setting energy objectives

and targets, and should include commitments to con-

tinual improvement of energy use and compliance with

applicable legal and other regulations. See the sidebar

“Energy Policy Statements” for some examples.

The approach an organization takes to manage en-

ergy consumption and efficiency is not only important

to its customers and employees, but also to its inves-

tors and stakeholders. This is why energy consumption

and productivity indicators play an important role in

all major sustainability evaluation models.9 Some ex-

amples of models include:

Global Reporting Initiative (GRI): GRI is a com-

prehensive sustainability reporting framework widely

used around the world. The following GRI indicators

are related to energy management and greenhouse

emissions:

• Direct energy consumption by primary energy

source (EN3).

• Indirect energy consumption by primary energy

source (EN4).

• Energy saved due to conservation and efficiency im-

provements (EN5).

• Initiatives to provide energy-efficient or renewable

energy-based products and services, and reductions

in energy requirements as a result of these initia-

tives (EN6).

• Initiatives to reduce indirect energy consumption

and reductions achieved (EN7).10

examples of inputs

• energy bills• Submeter data• Other variables such as

production and weather• Process flow diagrams

• Organization charts• Previous energy

assessments results• equipment lists• energy sources• energy policy

• Operations and financial information

• Legal and other requirements

• Operation and maintenance.• Other

Planning output Operations

• Baseline

• enPi (s)

• Objectives

• Targets

• Action plans

• Training

• Communication/engage stakeholders

• Operational control

• Procurement

• Design

1. Analyze energy use and other variables.

2. Significant energy uses and personnel.

3. Opportunities for improvement.

GraphsChartsTablesSpreadsheetsProcess mapsSankey diagramsenergy models

energy assessmentsPreventive/predictiveMaintenancePinch analysisroot cause analysisBenchmarksPareto analysis

review of BATenergy requirement analysisLCC analysisAssessing competenceOther

examples of tools/techniques

BAT = best available technology LCC = life cycle cost enPi = energy performance indicator

Source: international Organization for Standardization, ISO 50001:2011—Energy management systems

Steps in energy measurement and planning / fiGure 2

1. Analyze energy use and other variables

2. Significant energy uses and personnel

3. Opportunities for improvement

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October 2013 • QP 37

The Global 100 Most Sustainable Corporations

project: Based on formal assessments each year, Cor-

porate Knights Inc. names its Global 100 Most Sustain-

able Corporations in the World. These organizations

become well recognized among investors, customers

and stakeholders for their energy and carbon produc-

tivity, which are among 10 of Global 100’s key perfor-

mance indicators.11

The Dow Jones Sustainability Indexes (DJSI):

These indexes were launched in 1999 as the first global

indexes tracking the financial performance of the lead-

ing sustainability-driven organizations worldwide. The

DJSI assessment is based on a corporate sustainabil-

ity assessment method that covers economic, social

and environmental dimensions. The environmental

dimension includes eco-efficiency indicators that ad-

dress total energy consumption, direct greenhouse gas

emissions and trends in these areas against established

targets.12

energy consumption: measure, manage As you see from the business sustainability criteria

related to energy efficiency, the starting point is the

measurement of energy consumption. If you want to

manage energy consumption and efficiency, you first

must be able to measure it.

Figure 2 is derived from ISO 50001 and identifies

important steps in energy measurement and planning.

The graphic shows how energy assessment and mea-

surement data, energy bills, energy-related require-

ments and benchmarking information can be used to

conduct analyses of energy consumption.

The energy policy of an organization is an important

input to the analysis of energy consumption because

it defines the commitment to continual improvement

of energy performance and the commitment to ensure

the availability of resources to achieve energy objec-

tives and targets.

In turn, analysis of energy consumption and other

variables against energy objectives and targets helps

to identify opportunities for improvement. Identified

improvement opportunities should be translated into

specific action plans, enhanced operational control,

training and other activities.

Energy consumption measurements on prod-

ucts and operations and established targets and in-

formation about energy management initiatives

should be disclosed to stakeholders, including

ENERGY

3 EnErgy POLIcy StatEmEntSHere are three examples of effective energy policy statements:

— The energy policy of Sapa Heat transfer AB, a Swedish

company that develops and manufactures aluminium strips

for heat exchangers, includes commitment to the continual

improvement of energy use and emphasizes the importance of

new technology evaluation, measurement and improvement of

energy efficiency:

Sapa Heat Transfer AB shall be the leading supplier of heat

transfer solutions in aluminum. We use energy mainly in the form

of electricity and propane. Energy efficiency is an important part

of our company’s continued success and the energy management

system is a tool for a structured approach to achieve our goals.1

— 3M’s energy policy highlights the importance of innovation,

reliable energy supply and energy efficiency as a factor in product

development:

3M will promote the efficient use of energy to produce and

deliver products and services to its customers. The following steps

should be pursued:

• Emphasize energy efficiency as a factor in product develop-

ment and in process and facility design.

• Secure adequate and reliable energy supplies at the most ad-

vantageous rates and implement contingency plans to protect

operations from energy supply interruptions.

• Drive further development of internal and external energy-

efficient and innovative technologies.2

— Molson coors’ energy policy defines the importance of

developing a corporate culture of responsible energy man-

agement and engaging joint venture partners, suppliers and

customers:

Molson Coors believes that everyone in our company shares

the responsibility for protecting the environment and its natural

resources. We will:

• Develop a corporate culture of responsible management of

energy by educating, involving and motivating our employees.

• Establish business unit-specific energy management strategies

and plans.

• Engage our joint venture partners, suppliers, and customers to

develop business processes that are more energy-efficient.3

These energy policy statements establish a clear direction and

framework for setting energy objectives and targets.

—N.S. and G.C.

rEFErEncES1. Sapa Heat Transfer, “energy Policy,” www.sapagroup.com/upload/

sustainability%20report%202010.pdf. 2. 3M Corp., “3M Corporate energy Policy,” http://solutions.3m.

com/3MContentretrievalAPi/BlobServlet?locale=en_uS&lmd=1190299484000&assetid=1180581670690&assetType=MMM_image&blobAttribute=imagefile (case sensitive).

3. Molson Coors, “Corporate energy Policy,” http://www.molsoncoorscanada.com/en/ responsibility/~/media/af2080e2b28a45fa8f0bc5959b4d8f83.ashx.

Page 40: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

ENERGY

QP • www.qualityprogress.com38

investors and the interested public. This enables an

organization to increase transparency, improve its

reputation and credibility, and strengthen ties to com-

munities and stakeholders.13

call for collaborationEnergy efficiency of products and business operations

affects the bottom line of any organization, contributes

to business sustainability, helps attract customers and

improves relationships with investors and the commu-

nity. One of the most effective ways to manage energy

efficiency and use is through the implementation and

maintenance of an EnMS.

Standards that define guidelines and requirements

for EnMS on national levels have been in place for al-

most a decade in several countries including Sweden,

Ireland, Thailand, Korea, China and the United States.

ISO issued international standard ISO 50001:2011—

Energy management systems, which now represents

the global best practice in energy management.

Some of the most important elements of ISO 50001

relate to energy assessment and measurement, the es-

tablishment of an energy policy, energy planning and

improvement of energy efficiency. By disclosing energy

consumption data and information about energy man-

agement initiatives to stakeholders, an organization

increases transparency, improves its reputation and

credibility, and strengthens ties to all interested parties.

To address the increasing need for energy efficiency

as an important product and process quality attribute,

quality professionals must understand key principles

of energy management. Quality professionals can help

to establish EnMS by offering well-established quality

management processes and tools that can serve quality

and energy systems.

Examples of such processes relate to internal au-

dits, corrective and preventive actions, and manage-

ment review. Quality professionals can collaborate

with energy management teams to conduct root cause

analysis, benchmarking and internal audits to find and

document opportunities to reduce energy consumption

and improve efficiency.

Why is energy management so important today?

First and foremost, the global need for energy conser-

vation has increased enormously in recent years. Two

key reasons for this are:

• Increased energy consumption from population

growth and industrial development.

• Reduced capacities to meet the growing demand

for energy due to the depletion of nonrenewable

sources of energy.

Energy-saving products, programs, measures and

solutions help businesses to save money, improve cus-

tomer satisfaction, reduce risks of energy shortages,

and gain a competitive edge. QP

rEFErEncES anD nOtE1. “Quality Glossary,” Quality Progress, June 2007, p. 54.2. Katie Kerr, “A Healthier Family, Made Easy: Meet the Honest Company,”

Care2Make a Difference, July 25, 2012, www.care2.com/causes/a-healthier-family-made-easy-meet-the-honest-company.html.

3. Seat Corp., “Seat: Working for a Better Future,” www.seat.com/content/com/com/en/news_events/green-page.html.

4. St. Marys Cement Inc., “North America’s First ISO 50001 Certification for Energy Management Awarded to Canada’s Largest Cement Plant,” www. stmaryscement.com/saintmaryscementinc/_uploads/currentinfo/media%20release%20-%20bowmanville%20iso%2050001certification%20-%20nov%2023%202011.pdf.

5. Bentley Motors, “Crewe Sets New Benchmark in Energy Management,” Nov. 9, 2011, www.kent.bentleymotors.com/about-us/news/crewe_sets_new_benchmark_in_energy_management.

6. Samsung Electronics, “Energy Management,” www.samsung.com/us/ aboutsamsung/sustainability/environment/climatestrategy/ energymanagement.html.

7. Coca-Cola Corp., “Case Studies: Renewable Energy,” www. cokecorporateresponsibility.co.uk/big-themes/energy-and-climate-change/reducing-emissions-from-manufacturing.aspx.

8. International Organization for Standardization, ISO 50001:2011—Energy management systems.

9. Gary Cort and Natalia Scriabina, “Shaping the Trends,” Quality World, Vol. 3, No. 5, May 2009, pp. 18-23.

10. Global Reporting Initiative, “Reporting Framework Overview,” www.global-reporting.org/reporting/reporting-framework-overview/pages/default.aspx.

11. The method to tally the energy productivity scores can be found at The Global 100’s website at www.global100.org/methodology/criteria-a-weights.html.

12. “The SAM Corporate Sustainability Assessment,” Dow Jones Sustain-ability Indexes, www.sustainability-indices.com/sustainability-assessment/corporate-sustainability-assessment.jsp.

13. Cort, “Shaping the Trends,” see reference 9.

GARY CORT is principal at Exxeos Group in Phoenix. He holds a doctorate in physics from Texas A&M University in College Station. Cort is chairman of ISO/TC 176, which is respon-sible for the ISO 9000 family of standards.

NATALIA SCRIABINA leads business sustain-ability and corporate social responsibility training and consulting programs at Centauri Business Group Inc. in Waterloo, Ontario. She also participates in the development of Canadian national standards as a member of the Canadian Standards Association technical committee (TC) 2061 Organizational Social

Responsibility and member of the Canadian Advisory Committee to ISO/TC 242 energy management. Scriabina is a member of ASQ.

Page 41: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

Get There FasterNew take on value stream mapping helps measure, reduce transport waste

In 50 Words Or Less • A value stream map

(VSM), adapted to include swim lanes and transport operations as nonvalue-added steps, can help display and quantify transport waste, and pinpoint op-portunities for improve-ment.

• By adapting its VSM and combining it with other lean tools, one manufacturing facility saved an estimated 640 person-hours annually.

While traditional value stream maps

(VSM), 5S workplace organization and spaghetti diagrams are

crucial tools for the lean practitioner, they do not lend them-

selves readily to quantifying waste associated with transport-

ing things throughout a facility.

by Jonathon L. Andell

October 2013 • QP 39

lean

Page 42: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

QP • www.qualityprogress.com40

A VSM is effective at revealing bottlenecks

and excessive inventory, along with depicting

signals to relieve and replenish inventory. A

spaghetti diagram qualitatively depicts physi-

cal movement through the workspace, and the

5S method lays out a workstation for effective-

ness and efficiency. However, none of these

methods inherently quantify the distances and

times wasted due to transport.

There are tangible methods that can be fol-

lowed to identify, quantify and reduce trans-

port waste. Measurements can be used to esti-

mate person-hours consumed during transport

operations, and there are specific factors to

consider for identifying and implementing im-

provements.

linking spaghetti and value streamNeither the typical VSM nor a spaghetti dia-

gram or 5S does the entire job in the effort to

reduce transport waste. The typical VSM fo-

cuses more on times when things sit idle or are

touched, and less on when people and items

are moving from place to place. The spaghetti

diagram can reveal repeated and unnecessary

movement, but overlapping path lines can ob-

scure data analysis, and the diagram doesn’t

account for varying transport speeds. 5S is

more applicable to localized work than for

work involving transport.

One solution is to adapt the VSM so each

transport trip is depicted as its own nonval-

ue-added (NVA) process step. The left side of

Figure 1 shows an example of how such a step might

be depicted, next to a typical VSM process step on

the right.

The data entry boxes display somewhat different

information, which will be addressed later in this ar-

ticle. The shopping cart icon visually identifies the

transportation aspect.

The traditional aspects of a VSM include:

• Cycle time—the overall time a unit of work resides

at the step in question.

• Touch time—the time value-added work is being

done on a unit of work.

• First pass yield—the percentage of times the pro-

Value stream map terms for transport and touch steps / fiGure 1

obtain/deliver items

Process activity

feet per part = Cycle time =

Travel time per part = Touch time =

Percentage of parts = first pass yield =

One-way distance = Batch size =

One-way trips per part = frequency =

Staff by shift:

VA/NVAtimes

Items instorage

Ply preparationShared resource

Layup

Productioncontrol

AutoclaveShared resource

Baggingmaterials

and supplies

Items instorage

Ply preparationShared resource

Layup

Productioncontrol

AutoclaveShared resource

T/T = ____hours

C/T = ____ hours

Transport time = ____ sec/part

VA/NVAtimes

T/T = ____hours

C/T = ____ hours

Transport time = ____ sec/part

__ hours

__ hours

__ hours

__ hours

__ hours

__ hours

__ hours

__ hours

__ hours

__ hours

__ hours

__ hours

__ hours

__ hours

__ sec/part __ sec/part __ sec/part __ sec/part __ sec/part __ sec/part __ sec/part __ sec/part __ sec/part __ sec/part __ sec/part __ sec/part __ sec/part __ sec/part __ sec/part __ sec/part __ sec/part __ sec/part

[XYZ] current-state VSMmerges “disconnect” and

“de-bag” into a singlestep

Compositerolls

Trim anddrill

Schedule jobs/print travelers Deliver travelers

to ply cuttingC/T =T/T =FPY =Batch size =Frequency =Staff by shift

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

DisconnectTransfer cured parts

to debag areaFeet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Clean andprep tool

C/T =T/T =FPY =Batch size =Frequency =Staff by shift

Debag

Recycle? Yes

No

C/T =T/T =FPY =Batch size =Frequency =Staff by shift

Obtain tool fromstorage

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Deliver tool tostorage

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Deliver tool totool prep queue

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Deliverprepped tool

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Return visualsto storage

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Obtain thermocouplesand vacuum ports

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Deliverkits etc.

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Delivervisual aids

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Obtain tool(with kits etc.)

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Obtain othermaterials (if needed)Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Layup

C/T =T/T =FPY =Batch size =Frequency =Staff by shift

Cut plies andcoresObtain coils of ply

C/T =T/T =FPY =Batch size =Frequency =Staff by shift

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Deliver travelersto cool prep

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Plies and stickers to bag table and kit storage

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Using data from current-

state VSM

Rolls ofcomposite Storage

Toll storage

Baggingmaterials

Kits of pliesKits

Qty =Days’ worth =

Preprep(tools)

Qty =Days’ worth =

Postprep(tools)

Qty =Days’ worth =

Pre-layup

Qty =Days’ worth = Bag table

Qty =Days’ worth =

LayupObtain bagging

materialsFeet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Bag

C/T =T/T =FPY =Batch size =Frequency =Staff by shift

Deliver partsready for cure

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Transfer partsinto autoclave

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Load and connect

C/T =T/T =FPY =Batch size =Frequency =Staff by shift

Cure parts(auto-time)

Autoclave

Batch size

Cured partscart

Qty =Days’ worth =

Debagging

Quantity=Days’ worth =

Curedparts

• Data from [XYZ] current-state VSM• These steps were merged in vol (higher level) VSM

[XYZ] current-state VSM merges this step with debag

[XYZ] VSM merges 2 steps from this VSM:

“disconnect” and“debag”

Travelers

Travelers• Clean tools• Kits, cores• Visuals

Preppedtools

Dirty

tools

Parts

read

y for

cure

Parts ready for trim and drill

Overall value stream map / fiGure 2

C/T = cycle timefPY = first pass yieldNVA = nonvalue addedsec = seconds

T/T = touch timeVA = value addedVSM = value stream map

Page 43: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

October 2013 • QP 41

cess is executed correctly on the first attempt.

Figure 2 shows a VSM that includes processing

and transport steps. The purpose of showing such a

chart is not to exhibit details of the specific process,

which has been sanitized to comply with confiden-

tiality requirements; instead, it shows the overall

concept of depicting NVA trips as separate steps in

a complex flow.

Quantifying wasteTo generate processing steps, heed John Shook and

Mike Rother’s admonition to start at the customer

and work upstream.1 For transport, employ the phi-

losophy to “be the thing,” in which the thing is a unit

of whatever the process is intended to create, along

with whatever materials and fixtures must be trans-

ported to create it. Follow all paths taken from point

to point throughout the process. This applies whether

the thing is a physically manufactured item or a less

tangible transactional output. As long as the process

forces someone to move something from point A to

point B, there is transport-related waste to measure.

“Being the thing” enables you to record critical data

for each transport step:

• What is the typical distance?

• How many units of production are moved during

lean

VA/NVAtimes

Items instorage

Ply preparationShared resource

Layup

Productioncontrol

AutoclaveShared resource

Baggingmaterials

and supplies

Items instorage

Ply preparationShared resource

Layup

Productioncontrol

AutoclaveShared resource

T/T = ____hours

C/T = ____ hours

Transport time = ____ sec/part

VA/NVAtimes

T/T = ____hours

C/T = ____ hours

Transport time = ____ sec/part

__ hours

__ hours

__ hours

__ hours

__ hours

__ hours

__ hours

__ hours

__ hours

__ hours

__ hours

__ hours

__ hours

__ hours

__ sec/part __ sec/part __ sec/part __ sec/part __ sec/part __ sec/part __ sec/part __ sec/part __ sec/part __ sec/part __ sec/part __ sec/part __ sec/part __ sec/part __ sec/part __ sec/part __ sec/part __ sec/part

[XYZ] current-state VSMmerges “disconnect” and

“de-bag” into a singlestep

Compositerolls

Trim anddrill

Schedule jobs/print travelers Deliver travelers

to ply cuttingC/T =T/T =FPY =Batch size =Frequency =Staff by shift

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

DisconnectTransfer cured parts

to debag areaFeet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Clean andprep tool

C/T =T/T =FPY =Batch size =Frequency =Staff by shift

Debag

Recycle? Yes

No

C/T =T/T =FPY =Batch size =Frequency =Staff by shift

Obtain tool fromstorage

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Deliver tool tostorage

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Deliver tool totool prep queue

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Deliverprepped tool

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Return visualsto storage

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Obtain thermocouplesand vacuum ports

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Deliverkits etc.

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Delivervisual aids

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Obtain tool(with kits etc.)

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Obtain othermaterials (if needed)Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Layup

C/T =T/T =FPY =Batch size =Frequency =Staff by shift

Cut plies andcoresObtain coils of ply

C/T =T/T =FPY =Batch size =Frequency =Staff by shift

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Deliver travelersto cool prep

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Plies and stickers to bag table and kit storage

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Using data from current-

state VSM

Rolls ofcomposite Storage

Toll storage

Baggingmaterials

Kits of pliesKits

Qty =Days’ worth =

Preprep(tools)

Qty =Days’ worth =

Postprep(tools)

Qty =Days’ worth =

Pre-layup

Qty =Days’ worth = Bag table

Qty =Days’ worth =

LayupObtain bagging

materialsFeet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Bag

C/T =T/T =FPY =Batch size =Frequency =Staff by shift

Deliver partsready for cure

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Transfer partsinto autoclave

Feet per part =Travel time per part =% of parts =One-way distance =One-way trip per part =

Load and connect

C/T =T/T =FPY =Batch size =Frequency =Staff by shift

Cure parts(auto-time)

Autoclave

Batch size

Cured partscart

Qty =Days’ worth =

Debagging

Quantity=Days’ worth =

Curedparts

• Data from [XYZ] current-state VSM• These steps were merged in vol (higher level) VSM

[XYZ] current-state VSM merges this step with debag

[XYZ] VSM merges 2 steps from this VSM:

“disconnect” and“debag”

Travelers

Travelers• Clean tools• Kits, cores• Visuals

Preppedtools

Dirty

tools

Parts

read

y for

cure

Parts ready for trim and drill

A larger version of this figure is available on this article’s webpage at www.qualityprogress.com.

Page 44: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

QP • www.qualityprogress.com42

this particular NVA transport step?

• What is the mode of transport and typical speed?

Distance. A dependable distance measuring wheel

is invaluable. Walk it from one terminus to the other

for each trip identified in the adapted VSM. If a touch

step occurs at only one place, measuring that distance

is straightforward.

Some processes, however, entail multiple, similar

workstations, or sometimes work must be staged for

batch processing, as in the case of curing the com-

posite parts in a large autoclave. In these cases, use

a roughly central location to capture the average dis-

tance associated with that trip.

One-way trips per unit. After you know a specific

trip’s distance, you must quantify the one-way trips

per unit of output:

• Does an associate walk empty-handed one way, ei-

ther returning after a delivery run or heading out-

bound to obtain something? Alternatively, does the

operator take one item on the outbound trip and

bring back something else on her or his return?

Does transport occur as a simple round trip, or is it

part of a multistop loop of some sort?

• Is the item transported individually or in a batch?

What are typical quantities?

• Does this trip apply for some but not all units of

production? For example, in a composite layup

process, some—but not all—part types require spe-

cial alignment tools, which must be retrieved prior

to layup, the process by which two-dimensional

composite raw material is converted into a three-

dimensional shape, and afterward returned to stor-

age. Likewise, in nonmanufacturing processes,

certain situations might require additional signa-

tures. You would need to estimate the percentages

involved.

• How many operators are needed? To move some

large items, particularly on manufacturing floors, a

single operator may be insufficient.

• Is a vehicle of some sort needed? On manufacturing

floors, this can be a simple cart, forklift or dedicat-

ed fixture. If applicable, include travel to retrieve

and return the equipment.

• Are some trips repeated or extended due to some-

thing or somebody being unavailable at the antici-

pated location? In manufacturing, this might be

a piece of equipment in use elsewhere, while in

offices it might be somebody whose signature is

needed. Again, estimate frequency and additional

travel.

• Is waiting involved? Examples include waiting for

an elevator, for a shared vehicle to be free, or for a

signer to hang up a phone. Again, estimate frequen-

cies and durations.

• If appropriate, account for time to load or unload

things.

If the same items are transported at two different

stages during the process—such as the trips to re-

trieve and return alignment tools—those should be

depicted as separate steps in the VSM.

Transport speed. Because lean is, at its core, a

time-based strategy, the final task is to convert dis-

tances traveled into times consumed. Based on obser-

vations, here are some general guidelines:

• A person walking briskly—either empty-handed or

carrying something light—travels about 4 feet per

second.

• A person pushing a light cart goes about 3.5 feet

per second.

• When a person is carrying something weighing at

least 10 pounds or pushing a heavy cart, he or she

might move at roughly 3 feet per second.

Motorized vehicles and specialized transport fix-

tures have unique speeds that should be measured

directly. Remember to consider typical times starting

and stopping at corners, doorways and intersections.

Bringing it together. It is not practical to develop

a comprehensive equation that accounts for every fac-

tor covered already. For this discussion, we will use

two trips from the case study discussed later in this

Be wary of piecemeal adjustments that might shorten or eliminate one trip while increasing another.

Page 45: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

October 2013 • QP 43

article. Suppose the facility has a production volume

of 15,000 parts per year.

Example one: Delivering paperwork (one form

per part). Operators deliver a batch averaging 25 forms

and return empty-handed. The one-way distance is 210

feet, so the round trip is 420 feet. At 4 feet per second,

each trip consumes 420 ÷ 4 = 105 seconds. Because

each trip delivers 25 forms, however, the average time

is 105 ÷ 25 = 4 seconds per form. At 15,000 forms an-

nually, that translates to 60,000 seconds or 17 hours

per year.

Example two: Delivering raw materials. A dedi-

cated machine cuts a unique kit of plies for each part

being fabricated. Typically, an operator carries enough

plies for four jobs in one trip from the cutter to a sort-

ing table 60 feet away. He or she takes five seconds

to gather plies and five seconds to deposit them, and

then returns for more plies. The estimated times are

as follows:

• 5 + 5 seconds load/unload = 10 seconds.

• Carry plies to sorting table: 60 feet ÷ 3 feet per

second while burdened = 20 seconds.

• Return to cutting machine: 60 feet ÷ 4 feet per

second empty handed = 15 seconds.

Thus, a single round trip takes 10 + 20 + 15 = 45

seconds for four jobs, resulting in a mean time per kit:

45 ÷ 4 = 11 seconds.

After the kits are sorted, they are carried to shelves

near the cutting equipment, resulting in another 11

seconds per part, a total of 22 seconds per part, for an

annual total of 92 hours.

With diligence, you can quantify the mean time for

each transport step, which yields total annual trans-

port hours for the process. In turn, that total translates

into the equivalent number of workers executing NVA

transport and reveals the most wasteful trips.

attacking wasteAfter you understand the components of transport,

the next step is to reconfigure the workspace. Be wary

of piecemeal adjustments that might shorten or elimi-

nate one trip while increasing another. The objective

is to minimize total transport time without hindering

the touch time aspects of the process.

Seek to eliminate as many trips as feasible and to

shorten as many of the remaining trips as possible.

There are a number of factors to consider:

• What cannot be relocated in the near term?

Large equipment and major building characteristics

like shipping docks cannot be modified without

major capital investments. First, tackle what can

be moved. If capital expenditures are warranted,

you have the means to estimate return on invest-

ment (ROI) through labor reductions—and deliver-

ing lesser but rapid results generates credibility for

making your case regarding major investments.

• The seven flows: raw materials, work in progress,

finished goods, operators, machines, information

and engineering.

When considering options, determine which of the

seven flows can be changed. One opportunity may be

to co-locate needed items together.

Also, ask whether the floor can be configured to

improve flow.

Figure 3 shows three common configurations that

can support lean processing:

1. Straight through: Work arrives at one end and de-

parts at the other (Figure 3A).

2. U-shaped: Work arrives and departs through sepa-

rate portals, both located at the same side of the

work area (Figure 3B).

3. Loop: Work arrives and departs through the same

portal but flows within the work area (Figure 3C).

Of course, any design must account for replenish-

ing materials and supplies—part of the seven flows.

lean

Entry

Entry Same entryand exit

A. Straight-through layout

B. U-shape layout C. Loop layout

Exit

Exit

Common layouts for lean flow / fiGure 3A-C

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QP • www.qualityprogress.com44

Assess locations, routings and inventory

levels, order quantities for replenishment

and determine who has primary respon-

sibility for this—all in context with level

loading the entire floor.

• How much improvement will re-

sult? After you design a new floor

plan, predict labor reductions while

noting ergonomic and safety improve-

ments as ancillary benefits. After you

estimate the cost to reconfigure the

floor layout, you can estimate pay-

back period and ROI.

Case studyA manufacturing floor converts plies

of resin-impregnated fiber—essentially

sheets of two-dimensional materials—

into light, strong, three-dimensional

parts for subsequent assembly into a fi-

nal product. Due to client confidentiality, some details

in this example are withheld or disguised.

Figure 4 shows schematically how the floor was

configured in its as-evaluated state. Because the same

door is used to deliver empty fixtures to the layup floor

and to transport laid-up plies to the autoclaves, a loop

style of flow was selected as in Figure 3C (p. 43).

The longer dimension of the room (horizontal in

Figure 4) increased employees’ distances to retrieve

consumable supplies, which out of necessity entailed

multiple round trips per part produced. Because those

supplies require costly, environmentally controlled

storage systems, the team was constrained to a single

storage location. Rotating the flow 90 degrees, there-

fore, emerged as a way of shortening each trip,

and other benefits were realized. Red arrows

in the figure depict trips targeted for elimina-

tion, while blue arrows represent trips that

can be shortened.

Figure 5 shows the revised layout. To make

the new layout deliver desired results, five

lean-based process changes were implement-

ed concurrently:

1. Delivering kits to the fixture queue:

Eliminate the trip by routing incoming tool-

ing past the sorting table—integrated with the

third process change in this list—by installing

kit storage drawers beneath the top surface

of the sorting table. Process change: Pause at

the kit storage shelves and lay the appropriate

plies onto the fixture before continuing the de-

livery trip. Ergonomic benefit: Need to carry

heavy plies was greatly reduced.

2. Delivering alignment tools to fixture

queue: Eliminate this trip by relocating tools

Fixture kanban

Kit sorting and storage Alignment tool storage

ConsumablesLayu

p w

ork

stat

ion

s

Layup fixtures(kanban signal)

Parts ready for cure

Plies

Fixt

ure

s

Co

nsu

mab

les

Pickup kits Pickupalignment tools

Ply cutting equipment

Floor plan using loop style of flow / fiGure 5

Fixture queue

Consumables Fixtures

Kit sorting

Alignment tool storagePly cutting equipment

Kit storage

Arriving fixtures anddeparting parts ready for cure

Kit

s

Co

nsu

mab

les

Kits

Plies

Alig

nm

ent

too

ls

Current state floor plan (not to scale) / fiGure 4

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October 2013 • QP 45

next to the sorting table. Process change: Stop by the

alignment tool storage and obtain the needed tool.

Ergonomic benefit: Carrying heavy alignment tools

was greatly reduced.

3. Delivering cut plies to sorting table: Reduce

distance by relocating sorting table near cutting ma-

chine. Install drawers below tabletop to hold plies for

pickup during the first process change. Ergonomic

benefit: same as the first process change.

4. Bringing the next job’s layup fixture to the

workstation: Reduce the distance traveled. Process

changes: Eliminate a push-style queue at the edge of

the workspace and implement heijunka (visual sched-

uling) with a kanban (visual replenishment). Heijun-

ka, which is a Japanese word for workload leveling,

displays each workstation’s sequence of jobs for the

shift or the day. A kanban ensures needed items are

available on a just-in-time basis and that workers read-

ily can identify their next assigned job.

Each workstation had its next scheduled job in a

designated, nearby location. When the layup opera-

tor moves a part to the autoclave area for curing and

subsequently relieves his or her kanban position, the

empty parking space signals the need for that worksta-

tion’s next fixture, kit or alignment tool. Because ev-

ery layup operation takes at least an hour to complete,

there’s plenty of time to react to the signal and ensure

that the next job is ready when needed.

5. Obtaining consumable materials: Reduce

distance through a more centralized supply location.

Because these supplies require environmentally spe-

cialized storage, the best option was to select a floor

configuration and supply location to shorten the aver-

age transport distance. Rotating the floor 90 degrees

facilitates the shorter distance and improves flow

throughout the area.

As a result of these changes and based on current-

state productivity, estimated savings were 370 person-

hours annually—more than enough to supply resourc-

es to manage the heijunka and kanban.

Reducing queues and reorganizing fixture storage

areas were expected to reduce time spent tracking

down missing items, with a further estimated sav-

ings of 270 hours annually. The total of 640 hours was

equivalent to hiring one-third of a worker—with zero

increase in payroll.

Long trips between the layup and the curing areas

were not addressed due to prohibitive capital costs to

relocate large and costly equipment. The estimated

savings resulted mostly from moving some tables and

a few utility drops.

Additional benefits included increasing the number

of layup stations in the same floor space and reduc-

ing ergonomic exposure. The increase in workstations

enabled the area to bid for more business from other

parts of the parent company.

tools work togetherA practical enhancement to the spaghetti diagram

and the VSM is to quantify transport waste trip by

trip. Each trip can be depicted on the VSM as an NVA

process step, annotated in terms of the trip’s distance,

frequency and average duration.

The findings can be used to identify where and

how to alter workflows, quantify waste reduction, and

make a workplace more efficient and effective. Indi-

vidually, each tool is useful, but together, they operate

in true lean synergy. QP

ReFeReNCe1. John Shook and Mike Rother, Learning to See: Value Stream Mapping to

Create Value and Eliminate Muda, lean enterprise Institute Inc., 1999.

ACkNOWLedgmeNtThe author thanks Danette Harris, Wilfredo lantigua, Claude Burgin and David Foster at Boeing Defense Systems in Mesa, aZ, for their contributions to this article.

lean

Jonathon L. andELL is a Master Black Belt at Verizon in Basking Ridge, nJ. When he performed the work and drafted the article, he was president of andell associates LLC, a quality consultancy based in Gilbert, aZ. he has a master’s degree in metallurgy from Pennsylvania State University in University Park. andell is a fellow of aSQ.

The total savings of 640 hours was equivalent to hiring one-third of a worker—with zero increase in payroll.

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QP • www.qualityprogress.com46

Career Corner BY HenrY J. LindBorg

The Dilbert SyndromeWays managers can cure survey cynicism among employees

The DilberT comic strip is one of the

best satires on workplace cynicism. It

portrays a white-collar, micromanaged of-

fice featuring the engineer Dilbert as the

main character. In a recent strip (below),

Dilbert’s pointy-haired boss is pictured

reporting annual employee satisfaction

survey results at a meeting. Then, Dil-

bert’s boss assures staff that management

will never get such a low score again. The

final frame of the comic strip shows how:

The CEO cancels all future employee

satisfaction surveys.

I thought, “That could be a tempting

way to handle negative feedback for

some managers.” The comic strip targets

an important issue and the response it

may evoke. In recent years, employee

satisfaction surveys for a number of my

clients have pointed to a disconnect

between top management and staff. Poor

leadership scores in employee satisfac-

tion surveys suggests leaders may not

have the capacity to drive ongoing and

effective strategic change.

The Society for Human Resource

Management’s 2012 survey, “Employee

Job Satisfaction and Engagement: How

Employees Are Dealing With Uncertainty,”

found two of the top five factors influenc-

ing job satisfaction were relationships with

immediate supervisors and communica-

tion between employees and senior man-

agement.1 Relationships with immediate

supervisors affect an employee’s quality of

work life, but communication with senior

leadership makes an impact on employees’

contributions to organizational agility.

According to a recent study examining

corporate effectiveness, “Agility is not

just the ability to change. It is a cultivated

capability that enables an organization to

respond in a timely, effective and sustain-

able way when changing circumstances

require it.”2 Agility is critical for long-term

success and it guides an organization’s

identity and strategic intent. It promotes

conditions under which “information

flows easily, in both directions, between

both the bottom and the top of the orga-

nization.”3 Agility cannot flourish in an

atmosphere of distrust.

Culture of complaint If unaddressed, distrust of senior

management can generate a case of

real-world employee cynicism: negative

attitudes and disparagement based on

the belief that the organization lacks

integrity.4 A “culture of complaint” that is

resistant to the communication required

for strategic change, enterprise risk man-

agement, ethics and continual improve-

ment may emerge.5

Employees’ opinions about top

management are ever relevant for quality

managers. Special challenges may arise

when it’s time to partner with human

resources and conduct an employee satis-

faction survey. When attitudes toward

leaders are negative, how should the mes-

sengers—the quality managers—avoid

the scenario presented in the last frame

of the Dilbert cartoon? There are a num-

ber of things they can do to best handle

these sensitive situations:

1. Pay careful attention to survey

design, interpretation and deploy-

ment. Nothing is worse than putting

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october 2013 • QP 47

out fires caused by design flaws.

This may seem obvious, but most of

us have defense routines. We try to

invalidate bad news, especially with

statistical reasoning. The survey

has to stand up to scrutiny. Also,

we tend to get defensive when we

are approached unprepared. Senior

managers must be involved at all

stages, share their assumptions about

the survey’s effectiveness and agree

to an improvement plan to address

the results.

2. Ensure results are reported by a

seasoned consultant, facilitator

or coach experienced in working

with leadership. Traditionally, sur-

vey results are cascaded and present-

ed to leadership first. Beyond respect

for the propriety and order demanded

by an organization’s hierarchy, this

serves a number of purposes. A clear

executive summary highlights the

results and what they mean. CEOs,

who may report to boards and the

public, need a clear message to com-

municate.

3. Set the tone. After executives have

reviewed the survey data and have

been assured of the survey instru-

ment’s validity and reliability, focus

on messaging. A presentation on the

findings that is geared toward execu-

tives can help establish a communica-

tion plan to report results throughout

the organization.

4. Enhance trust in the organiza-

tion, beginning at the top. If senior

managers were criticized for their

compensation packages—or have

recently picked up talk show host

and psychologist Phil McGraw’s book

on self-protection—Life Code: The

New Rules for Winning in the Real

World—they may be a little cynical

themselves.6

Remind executives that responding to

an employee satisfaction survey is an act

of faith that change is possible. When em-

ployees respond to a satisfaction survey,

they expect the organization to use that

information to make a positive change.

If a survey is conducted and nothing

changes, the exercise contributes to

everyone’s cynicism. Employees want to

be heard and to see results. At the same

time, they fear participating. If trust is an

issue, guarantees of confidentiality and

freedom from retaliation are essential.

Management should simply acknowledge

the present state and provide paths for

change.

“Gotchas” and negative comments

from staff members who responded to

the survey may lead to that final Dilbert

frame. Communication is an organiza-

tionwide issue and it raises questions

about how to learn and improve together.

Ironically, surveys also test communica-

tion. Discussing issues raised by surveys

with workgroups, especially smaller

ones, may yield limited results. Patterns

of thought and influence may simply re-

inforce the status quo. Quality managers

should consider large-scale conversations

with diverse participants.

Quality professionals’ experience

with large-scale events and improvement

teams offers credible approaches for

change. However, those processes, too,

have to be carefully designed to avoid the

Dilbert trap. QP

references1. Society for Human resource Management, “2012 em-

ployee Job Satisfaction And engagement: How employees Are dealing With Uncertainty,” 2012, www.shrm.org/peopleinsight.

2. Thomas Williams, Christopher g. Worley and edward e. Lawler iii, ”The Agility Factor,” Strategy+Business, April 15, 2013. www.strategy-business.com/article/00188?gko=6a0ba.

3. ibid.4. James W. dean, Jr., Pamela Brandes and ravi dharwadkar,

“organizational Cynicism,” The Academy of Management Review, Vol. 23, no. 2, April 1998, pp. 341-352.

5. robert Kegan and Lisa Laskow Lahey, How the Way We Talk Can Change the Way We Work: Seven Languages for Transformation, Jossey-Bass, 2001.

6. Phil Mcgraw, Life Code: The New Rules For Winning in the Real World, Bird Street Books., 2012.

remind executives that responding to an employee satisfaction survey is an act of faith that change is possible.

lessons from linDborgFind more career advice from Henry J. Lindborg in the Career Corner archive under the “Departments and Columns” tab on www.qualityprogress.com.

HeNRy J. LiNdboRg is executive director and Ceo of the National insti-tute for Quality improvement in Fond du Lac, Wi, which provides consulting in strategic planning, organizational development and assessment. He holds a doctorate from the University of Wisconsin-Madison and teaches

in a leadership and quality graduate program. Lindborg is past chair of ASQ’s education division and of the education and Training board. He also chairs the ieee-USA’s Career Workforce Policy Committee.

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QP • www.qualityprogress.com48

StandardS OutlOOk by Les schnoLL

regulatory nightmares Is a retrospective activity worth the cost and aggravation?

“Do it right the first time” is a mantra

often used by quality professionals. In the

associated world of regulatory affairs and

compliance, this adage also represents an

appropriate mindset.

Throughout my career, first as an

employee and currently as an independent

consultant, I have seen far too many times

when this slogan was not taken seriously.

While I could provide countless examples

on the quality side, for purposes of this

article I’ll concentrate on the impact of

retrospective regulatory activities required

because organizations and their manage-

ment did not do it right from the beginning.

The number of potential regulatory

disasters is quite large, but I have my own

list of the top five nightmares that illus-

trate my point. Of course, organizations’

specific names have been eliminated to

protect the guilty.

Nightmare No. 1: “I didn’t know my

products were considered drugs or

devices.”

This lapse of judgment has significant

implications, all of which could result in

the affected products being considered

misbranded and adulterated—and poten-

tially recalled.

Consider this not-so-hypothetical

scenario: A manufacturer of a class II

medical device, which requires a 510(k)

premarket notification submission,1 has

distributed its product into U.S. inter-

state commerce and into other countries,

including Canada, Europe and Australia.

There is not a quality system in place—the

organization did not know that it needed

one. In addition, the organization has not

trained its employees, and it does not have

a registration and listing, device master

record (DMR), design history file (DHF) or

510(k) submission.

Without these items, the product is

adulterated and misbranded. In Canada,

without complying with the registration

and quality system requirements, Health

Canada can mandate a recall. In the Euro-

pean Union (EU), failure to comply with

the applicable medical device directive

also can result in significant penalties.

During my career, I have seen this situ-

ation numerous times. Theoretically, the

U.S. Food and Drug Administration (FDA)

would be well within its authority to

require that the organization recall all of

the products it ever manufactured. Many

times, however, the agency exercises

enforcement discretion and allows the

products to remain on the market if the

organization complies with all regulatory

requirements within a reasonable period

of time.

After the organization meets its obliga-

tions, virtually everything must be created

retrospectively. If you have ever been in a

situation like this, you know that correc-

tive action is not easy. While it is relatively

simple and straightforward to develop

the quality system, and to register and

list the facility and manufactured medical

devices, it is not a pleasant task to retro-

spectively create a DMF, DHF or technical

file for the EU.

Developing and submitting a 510(k)

takes significant time and can be expen-

sive. The delays required to restart sales

could range from several months to more

than one year. During this period, the orga-

nization faces a negative cash flow—noth-

ing is coming in, but expenses to imple-

ment the corrective actions are ongoing.

My advice to the small entrepreneur

who wants to enter the regulated arena:

Be sure you know what you’re getting

into, research the regulatory status of your

products and if you’re not positive about

the status, hire someone who can help

you before you get yourself into serious

trouble.

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Nightmare No. 2: “I didn’t audit

my key subcontractors before using

them.”

While the following paragraph is an ex-

cerpt from a case study I use in my auditor

training program, it is, unfortunately, not

too far from the truth in a few organiza-

tions I’ve visited.

“The buyers are in control and knowl-

edgeable about what is happening. As

such, suppliers are approved by the buy-

ers, and the company always gets credit

for rejected materials.”

Regulatory requirements for approval

of suppliers for medical devices can

be found in the FDA’s Code of Federal

Regulations Title 21 (21 CFR), Section

820.50—Purchasing controls. It states

that manufacturers “shall establish and

maintain the requirements, including

quality requirements, that must be met by

suppliers, contractors and consultants.”2

Simply being knowledgeable buyers isn’t

enough.

For the unfortunate organizations that

must retrospectively assess their suppli-

ers’ capabilities, especially for services

and components considered to be critical

to the products, there can be disastrous

consequences, including recall of mar-

keted products and being forced to stop

marketing the existing product until a

suitable replacement supplier is identified

and approved.

Once, I audited a supplier of a patient-

contact accessory to a medical device.

The product was manufactured in a facil-

ity in China that was filthy, infested and

completely unsuitable for manufacturing

any product, let alone a medical device.

Prior to my audit, no one from the com-

pany had visited the facility—the deciding

factor had been that it was cheaper to

purchase from that supplier than from any

other subcontractor.

Needless to say, my client was not

happy with my report, probably prefer-

ring to remain clueless and continue on as

is. The end result was that the approved

supplier was disapproved and the product

was taken off of the market. Extensive

testing provided the organization with

sufficient data to preclude the need for a

product recall.

Nightmare No. 3: “What is process

validation and what does this have to

do with me?”

Process validation, as required by 21

CFR Section 820.75, is a project that can

keep a team busy for months.

Validation is required when “the results

of a process cannot be fully verified by

subsequent inspection and test.”3 This

means unless the organization performs

100% inspection and testing (meaning the

process is fully verified), the process must

be validated. Not completing this activity

once again results in adulterated products.

Regulatory agencies expect that valida-

tion activities are prospective, or they are

completed before the first unit of product

is distributed. The excuse of “I didn’t

know” or “No one told me that I had to,”

just doesn’t cut it. For those organizations,

their only out is to perform a concurrent

or retrospective validation, both of which

are frowned on by the FDA.

Concurrent validation is considered by

many to be medium-risk mitigation to a

regulatory violation; retrospective valida-

tion is considered by those same people to

be high risk. I think both are high risk.

Concurrent validation is basically con-

tinuing to manufacture product and put

it into interstate commerce while using

the next three lots or batches to perform

the validation. “Not too bad,” some may

say. The organization is moving forward

to resolve the issue, so the opinion is that

this is a medium-risk activity.

But think about it a bit more: Yes, the

organization is taking action—but what

happens if the validation fails and the

failure warrants a product recall? All the

organization has achieved is putting more

products into the market that must be

recalled, increasing its costs and creating

an administrative nightmare—not a very

good solution.

Retrospective validation is performed

using historical data to attempt to validate

the process. The data may show the

process is acceptable, and because the

organization didn’t know it was regulated

to begin with, what are the odds the data

and records are less than impeccable?

Either way, there are hurdles to

overcome, including ongoing suspicions

by the FDA that tighter scrutiny may be

warranted for those organizations for the

foreseeable future.

Nightmare No. 4: “We can’t find our

DMR.”

It doesn’t matter whether your medical

device is a tongue depressor, intraocular

lens or volume ventilator—a DMR is not

optional. The requirement in 21 CFR Sec-

tion 820.181 is clear: “Each manufacturer

shall maintain device master records.”4

The DMR is the recipe for the device

and includes everything needed to manu-

facture, test, inspect, package, label, store,

To the small entrepreneur who wants to enter the regulated arena: be sure you know what you’re getting into.

October 2013 • QP 49

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QP • www.qualityprogress.com50

StandardS OutlOOk sterilize (if applicable), service and dis-

tribute the product. Not having one results

in products being adulterated.

Not realizing the DMR is needed and

creating one retrospectively is not a big

deal—it just takes time to gather the infor-

mation—assuming the information is avail-

able to gather—and putting everything into

an acceptable format. Not realizing that

this key document is needed does nothing

to help the organization’s relationship with

the FDA, but it is something that can be

overcome with time.

Having a DMR at one time and losing

it is another matter. A former employer

had a DMR for an obstetrical monitoring

system manufactured at one of its facili-

ties. While document management was

generally pretty good at this organization,

for some unknown reason, the only copy

of the DMR for this device was stored on

the hard drive of an engineer’s desktop

computer, which was never backed up

anywhere.

For reasons still unknown, more than

10 years after the fact, the hard drive on

this computer was reformatted and the

DMR and everything else ceased to exist.

Four years and about $7 million later, the

DMR was retrospectively recreated and

the organization began to sell the product

again. During the time it took to resur-

rect the DMR, the organization could not

distribute the product.

Nightmare No. 5: “Our employees

have been with us forever and don’t

need to be trained.”

21 CFR Section 820.25(b) of the quality

system regulation requires that manu-

facturers “identify training needs and

ensure that all personnel are trained to

adequately perform their assigned respon-

sibilities.”5 In addition, all training must be

documented.

If an organization’s seasoned employees

were adequately trained and the training

was documented, it may be OK—partially.

However, because the FDA considers

training in the regulatory requirements,

such as the quality system regulation or

the good manufacturing practices (GMP),

to be required training and the organiza-

tion didn’t know it was regulated, that

training probably never took place.

My favorite warning letter of all time—

because I never worked or consulted for

the organization—was one issued by the

FDA Atlanta district office in 1998. The

letter includes descriptions of violations

with respect to training:

You have failed to assure that each person

engaged in the manufacture, processing

and packaging of your drug products has

the education, training and experience

to enable that person to perform their

assigned functions. No one at this facility

exhibited a basic knowledge or under-

standing of the GMPs.

Your quality control manager stated

that he had never read the GMPs. No em-

ployee involved in the production of your

drug products had been trained in GMPs.

The laboratory technician responsible for

performing microbiological testing had

received no training in microbiology.6

Seldom does the FDA reach a conclu-

sion about the cause of a violation in its

warning letters, but in this case, it did:

This lack of training and understanding

could possibly explain the confusion

exhibited by key personnel at your firm

about which products at your firm should

be considered as drug products.7

How would you like to be the CEO of

this organization and open this letter from

the FDA first thing in the morning?

You should knowI’m not sure who first came up with the

statement, “You don’t know what you

don’t know,” but in the world of regulatory

affairs, what you don’t know may just be

the tip of the iceberg. In the continuum of

knowledge (or lack thereof), you might

use the following sequence:

1. You know.

2. You don’t know.

3. You know what you don’t know.

4. You don’t know what you don’t know.

5. You don’t know what you don’t know

you don’t know.

There are consequences associated

with each of these statements, but regula-

tory agencies really don’t care that you

don’t know—ignorance is not an excuse in

their eyes.

It does not matter if your regulated

product is a medical device, drug, biolog-

ic, food or cosmetic—before you get into

a business regulated by the FDA, you must

fully comprehend what you’re getting into.

Failure to do your homework can result in

serious consequences for your organiza-

tion, employees and patients. QP

references anD note1. 510(k) is a premarket submission made to the U.s.

Food and Drug Administration to demonstrate the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval. Find more information at www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/default.htm.

2. U.s. Food and Drug Administration, Code of Federal Regulations Title 21, Section 820.50—Purchasing controls, revised April 1, 2013.

3. U.s. Food and Drug Administration, Code of Federal Regulations Title 21, Section 820.75—Process validation, revised April 1, 2013.

4. U.s. Food and Drug Administration, Code of Federal Regu-lations Title 21, Section 820.181—Device master record, revised April 1, 2013.

5. U.s. Food and Drug Administration, Code of Federal Regu-lations Title 21, Section 820.25—Personnel, revised April 1, 2013.

6. Letter from ballard h. Graham, director of U.s. Food and Drug Administration Atlanta district office, to Medical Packaging Technologies Inc., Aug. 18, 1998, www.fda.gov/downloads/IcecI/enforcementActions/

WarningLetters/1998/UcM066722.pdf (case sensitive).7. Ibid.

LES SCHNOLL has more than 35 years of experience in industries regulated by the Food and Drug Administration (FDA). He is a senior member of ASQ and an ASQ certified quality engineer, auditor and manager. A former member of the U.S. technical advisory group to ISO technical committee

176, Schnoll wrote The Regulatory compliance Almanac (Paton Press, 2001, 2008). He is currently the principal of Quality Docs, LLC, providing quality and regulatory consulting services to FDA-regulated industries. He also teaches several courses in master’s degree programs in regulatory affairs at Arizona State University and Northeastern University.

Page 53: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

Get a JobProfessor encourages students to seek certification

Long gone are the days when a col-

lege degree was enough to land a job.

The entry-level employment market has

become increasingly competitive during

the last decade. Graduates entering the

workforce are expected to develop skills

and experiences outside of the classroom.

They must have more to offer organiza-

tions than their newly conferred degrees.

As an associate professor and director

of the master’s of health administration

degree program at Texas A&M University’s

Health Science Center, I am responsible

for facilitating students’ pursuit of post-

graduate fellowships and entry-level

employment in the healthcare industry. I

am also a senior member of ASQ.

My approach to cultivating students

who will be ready to hit the ground run-

ning has been three-fold. First, I encour-

age students to work for one of the uni-

versity’s local healthcare partners while

completing their studies to gain on-the-job

experience. Second, at the campus level, I

encourage leadership or participant roles

in our student-run organizations, including

student chapters of the Association for

Future Healthcare Leaders, the Institute

for Healthcare Improvement and the

Medical Group Management Association.

Last, an important third component is that

students obtain external evaluation and

validation on a specific body of knowledge

in the form of certifications from profes-

sional organizations.

Certify for successQuality certifications are becoming an

essential résumé credential of today’s

prospective healthcare employee. I have

taught a graduate course on healthcare

quality and process improvement for 10

years and began referring students to

ASQ’s certification program about five

years ago. Initially, maybe a handful of

students would heed my recom-

mendation and pursue certifica-

tion. Within the last three years,

however, more and more of my

students are taking the plunge.

ASQ certification provides:

• A sense of accomplishment.

Translating what they learned

into a tangible achievement

such as an ASQ certification is

invaluable. Almost immediately

after my students receive their

certification results, my email

inbox becomes flooded with

(usually) good news and screenshots of

their exam results. As an educator and

a senior member of ASQ, I am so proud

of them.

• Greater employment prospects.

When my students apply for fellowships

or jobs, their ASQ certification often

garners the most attention on their

résumé. While the healthcare industry

sees quality and process improvement

as necessary, rates of formal recogni-

tion of quality skills and knowledge still

lag behind other industries.

• A credential that distinguishes my

students from other applicants for

a job or fellowship. Students tell me

their ASQ certification was one of the

deciding factors for a job or fellowship

offer.

On average, about 10 of my students

earn certifications each year. This past

summer, three of my students were certi-

fied as quality improvement associates,

three received Six Sigma Green Belts, two

achieved process analyst certifications

and one earned the lean bronze certifi-

cation. To date, 36 of my students have

become certified, and five earned multiple

certifications. Equally important, most

remain ASQ members after graduation.

Of course, I acknowledge there is

another link in the relationship between

post-graduate success and certification.

Students who are generally ambitious

and focused on their careers tend to be

more successful. These are the students

who recognize that certifications are an

important mark of achievement that can

help distinguish them.

As an educator, one of my responsibili-

ties is to present as many opportunities

as possible to my students so they are

prepared to succeed. Certification from

ASQ has become a valuable resource for

me as an educator and for my students as

job seekers. QP

Murray J. Côté is the director of the master’s of health administration program and an associate professor at the texas a&M university Health Science Center in College Station. He earned a doctorate in management science from texas a&M university. Côté is a senior member of aSQ.

Quality in the First Person BY MurraY J. Côté

october 2013 • QP 51

Page 54: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

Digital CNC Heidenhain’s TNC 620, a digital computer

numerical control (CNC), can be custom-

ized with various features and software

options giving machine builders and end

users the ability to tailor the CNC to their

specific needs.

End-user functions available on the TNC

620 such as the new DXF converter allows

the user to open DXF files directly on the

TNC to extract contours, point patterns or

machining positions.

When programming away from the

machine, the TNC 620 automatically takes

machine geometry into account—tilting

the working plane, conducting cylinder

surface machining, 3-D tool compensation

and fast execution through short-block

processing times, enabling it to handle

complex operations.

Another important feature of the TNC

620 control is that it dynamically calcu-

lates and adapts to conditions.

• Visit: www.heidenhain.us.

• Call: 877-565-9151.

Dynamometer system •Sakor Technologies has announced the Ac-

cuDyne AC dynamometer system for wind

power testing applications. The system can

be used by multiple engineering groups to

test and verify designs, as well as for qual-

ity control testing after manufacturing. It

is ideal for testing active and passive wind

power driveline components.

The AccuDyne dynamometer system

can be used to test turbines and their as-

sociated blade pitch control motors, gen-

erators, wind-sensing devices and motors,

and transmissions. The system also can

be used for testing water coolant pumps

and other ancillary components.

The AccuDyne comes packaged with

the DynoLAB EM system. It features the

ability to simulate inertia to test a wide

range of large and small loads, torque

pulse simulation for simulating compo-

nents that exhibit cogging, and noise,

vibration and harshness testing.

• Call: 517-332-7256.

• Visit: www.sakor.com.

Position gaging systemAlbion Devices has announced the

introduction of its non-contact ultrasonic

gaging and positioning systems. These

gages use air coupled, pulse echo acoustic

technology which permits noncontact gag-

ing for industrial applications.

Noncontact ultrasonic dimensional gag-

ing applications include measurement of

thickness, distance, position, perpendicu-

larity, shape and orientation.

Other options for gaging include the

use of parabolic mirrors for focusing, tilting

mirrors for sound directional changes, and

shaded apertures for surface detail in clut-

tered backgrounds.

Albion’s gages include the model UT

200 for noncontact thickness or outside

dimension measuring, the model UI 210

QP • www.qualityprogress.com52

QPTOOLBOX

Page 55: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

for noncontact internal measurement and

the model UD 100 for noncontact distance,

position, fill level or movement measure-

ment.

These models offer industrial users

reliable, noncontact means to control

production of such items as particle

board, acrylic sheets, plywood and glass,

and to measure distances, movement and

fill levels, among potential quality control

applications.

• Email: [email protected].

• Visit: www.albiondevices.com.

Surface mount accelerometer •

Silicon Designs has introduced its model

1521 surface mount accelerometer series.

The model 1521 series features non-ferrous

construction and a nitrogen-damped

micro-electro mechanical system sensing

element. The model 1521 series is also

insensitive to temperature changes and

gradients, with signal output unaffected by

electromagnetic interference and requiring

no warm-up period.

Supported applications include oil and

gas downhole monitoring, inertial measure-

ments, tilt and position measurements

for antennas, solar panels, wind turbines,

hydroelectric spillway doors, and elevators,

civil structure seismic monitoring, industrial

vibration monitoring and analysis, robotics

and machinery control.

• Visit: www.silicondesigns.com.

• Call: 425-391-8329.

Measurement sensorSolartron Metrology has introduced the G-

Type position and linear displacement mea-

surement sensor with direct analog output.

The G-Type models feature a linear variable

differential transducer as the measuring el-

ement, and they also offer a choice of four

measuring ranges: 2, 5, 10 or 20 mm.

The G-Type sensor incorporates Solar-

tron Metrology’s AX probe into its design.

The probe’s tight tolerance, cartridge-type

bearing with chrome and carbon balls en-

sures that the G-Type supplies non-repeat

linear measurements, while sustaining a

long product life.

• Visit: www.solartronmetrology.com.

• Email: [email protected].

Density meterProducts in the petrochemical industry are

often highly viscous and therefore not al-

ways easy to measure. To cope with these

challenges, Anton Paar has developed

Modulyzer for Petro. In its basic configura-

tion, Modulyzer for Petro is a combination

of a DMA 4100/4500 M density meter or a

DMA 5000 M, an Abbemat-HP/WR refrac-

tometer and an Xsample Heated for the ef-

ficient, flexible and modular measurement

of highly viscous petrochemical samples at

temperatures of up to 80° C.

In addition to its modular concept, Anton

Paar’s Modulyzer for Petro offers advantag-

es such as simultaneous measurement of

density, and the refractive index and auto-

mated filling by Xsample Heated. Modulyzer

for Petro is designed for plug-and-play

installation, requires small sample volumes

and protects operators from exposure to

putrid or hazardous solvents.

• Visit: www.anton-paar.com.

• Call: 800-722-7556 x118.

October 2013 • QP 53

Got a quality product?Send your product description and photo to [email protected].

Page 56: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

QP • www.qualityprogress.com

The Market-Driven Supply Chain: A Revolutionary Model for Sales and Operations Planning in the New On-Demand EconomyRobert P Burrows, III, foreward by Lora

Cecere and Gregory Hackett, Amacom, 2012,

288 pp., $39.95 (book).

In this book, Burrows

provides the trans-

formational steps

required to achieve a

market-driven supply

chain resulting in a

business that is highly

responsive to the de-

mand economy, while

also allowing for specific customer needs to

be addressed and delivered.

Market segmentation is required to

achieve sales and operations planning

(S&OP). After a business has decided how

to section the market, it must determine

how to deliver value to customers. The four

traditional strategy options are: lowest cost,

highest market share, location advantage

and innovative leadership. Proper data as-

sessment helps decide which is best suited

for your business plan.

Each chapter contains many illustra-

tions and graphs, a summary that reviews

the important points and a case study. This

helps illustrate the concept and its imple-

mentation. There is also an index for finding

specific issues or areas of focus.

It will take hard work and dedication to

convert your business to this type of opera-

tion. Fortunately, Burrows includes a change

agent model that includes communication,

collaborative execution and performance

measures. The guiding principles of S&OP

are always foremost in the discussion and

execution.

It will take time and a dedicated team,

but after the model is in place, your busi-

ness should become more efficient, cus-

tomer responsive and it will grow.

Marc A. Feldman

Solvay Chemicals, Inc.

Houston

Auditing Beyond Compliance: Using the Portable Universal Quality Lean Audit Model Janet Bautista Smith, ASQ Quality Press,

2012, 112 pp., $20 member, $34 list (book

and CD-ROM).

This book is an eye open-

er and a useful reminder

for other management

system auditors who are

searching for ways to

conduct more value-

added audits. The author

introduces the portable

universal quality lean (PUQL) audit model

which, when used in conjunction with several

simple and commonly used lean Six Sigma

tools, can lead to identification of opportuni-

ties for improvement, innovation and growth.

The PUQL model uses an audit template

that integrates the compliance verification

and improvements that can be applied to

standards, processes and products. Two

unique concepts introduced in this book that

differentiate it from other auditing books are:

• The PUQL model itself which, like a univer-

sal adaptor, allows the auditor to connect

to and use several different management

system standards interchangeably.

• The concept that audits are not simply

compliance tools but also can be em-

ployed to improve business management.

Although the book is written for first-par-

ty auditors, there is no reason second and

third-party auditors could not benefit from

the PUQL audit model. The book comes with

a CD-ROM that includes a MS PowerPoint

presentation on auditing beyond compli-

ance training, and the PUQL template and

its introduction document. I found several

typographical errors in the book, and the fact

that the PUQL template is in a PDF format

makes it difficult to use. However, I strongly

recommend this book for both novice and

experienced auditors alike.

Herzl Marouni

ABS Consulting

Houston

Reliability and Availability Of Cloud Computing Eric Bauer and Randee Adams, Wiley-IEEE

Press 2012, 352 pp., $65.60 (book).

This is a wonderful book

written in a clear and

comprehensive way by

two experienced ex-

perts. The authors’ audi-

ence consists of system

architects, developers,

engineers, sales people,

product management

and quality management professionals.

The authors address issues of reliability,

availability and risks of information system

services, including detailed risk mitigation

strategies. The book discusses aspects of

virtualization, capacity and elasticity, service

orchestration, geo-redundancy and disaster

recovery.

What is missing—but could probably be

part of a follow-up book—are examples

of data analysis and reporting. The topic

deserves a wider treatment of statistical

analysis and data analytics related to the

topic at hand.

The book is well-written and compre-

hensive. It can be used as a reference for

anyone involved in cloud computing. It is

QPREvIEWS

54

Page 57: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

highly recommended to practitioners, users,

developers and researchers in this challeng-

ing and state-of-the art domain.

Ron S. Kenett

KPA Ltd.

Raanana, Israel

The Metrology Handbook Jay L. Bucher, editor, ASQ Quality Press,

2012, 540 pp., $99 member $139 (book and

CD-ROM).

This book is written as

a practical metrology

reference for calibra-

tion professionals.

Therefore, the lan-

guage used in the book

is industry oriented.

The first section of the

book provides a good overview of the history

and philosophy of metrology and calibration.

The section on quality systems includes the

essential aspects of metrology and calibra-

tion that are a part of any quality system. A

chapter dedicated to environmental controls

for metrology is a surprise and a welcome

addition because few books on metrology

cover environmental controls in such detail.

From the point of view of practical

implementation, there is a section on start-

ing and managing a metrology department

or calibration laboratory. An entire chapter

is dedicated to explaining measurement

uncertainty.

There is a section on measurement pa-

rameters that covers direct current and low

frequency, radio frequency and microwave,

dimensional and mechanical parameters,

and other parameters including chemical

parameters, electro-optical parameters and

analytical parameters.

The section on mathematics and sta-

tistics serves as a primer on conversions,

ratios, statistics and mensuration. Formulas

for calculation, volume and surface area of

commonly used geometric shapes and sol-

ids are included. Information about the body

of knowledge for ASQ’s certified calibration

technician exam is provided in an appendix.

The book is accompanied by a CD-ROM

containing readily usable information such

as statistical tables and formulas, metrol-

ogy, math, and engineering formulas, units

and conversions, and a PDF file of acro-

nyms used in the field. In addition, several

useful calculators and MS Excel worksheets

are provided, including an uncertainty

calculator, a tolerance calculator, and a

worksheet with examples of uncertainty.

This book is intended for metrology and

calibration practitioners in a broad range of

fields. Those looking for detailed informa-

tion on specific gages and measurement

devices used in a traditional manufacturing

organization must supplement their reading

of this book with another book that covers

those aspects in detail. This book is a must-

read for anyone attempting to gain a strong

foundation in the field of metrology and

measurement, and belongs in the library of

every metrology and calibration practitioner.

Rangarajan Parthasarathy

Harvard, IL

RECENT RELEASEThe Executive Guide to Innova-tion: Turning Good Ideas Into Great Results Jane Keathley, Peter Merrill, Tracy Owens,

Ian Meggarrey and Kevin Posey, ASQ Quality

Press, 2013, 184 pp., $18 member, $30 list

(book).

55

Advertisers IndexADvERTISER PAGE PHONE WEBABC ISO Consultants 61 855-476-9001 www.abcisoconsultants.comAIAG 61 248-358-3003 www.aiag.orgAlpha Training and Consulting 63 801-942-9274 www.alphatc.comAmerican Petroleum Institute 59 202-682-8000 www.api.orgAQS Management Systems 63 763-746-0505 www.aqsperformance.comASQ Membership Application 2 800-248-1946 www.asq.orgBSI Group America Inc. 65 888-429-6187 www.bsiamerica.comEtQ Inc. 1 516-293-0949 www.etq.comIICT Enterprises LLC 65 612-387-6310 www.iictenterprisesllc.comMilwaukee School of Engineering 57 http://www.msoe.edu/hr/Minitab Inc. 67 800-448-3555 www.minitab.comPQ Systems Inc. 67 800-777-3020 www.pqsystems.comPredisys Inc. 69 978-662-5213 www.predisys.comQiSOFT 69 912-790-7990 www.qisoft.comQuality Council of Indiana 10, 11 800-660-4215 www.qualitycouncil.comQuality Essentials Suite 71 866-949-9504 www.qualityessentialssuite.comQuality Solutions Inc. 71 800-471-1646 www.qualitysolutions.comQualityWBT Center for Education 73 800-737-4488 www.qualitywbt.orgResource Advantage Inc. 57 518-663-5232 www.resourceadvantageinc.comSigmaXL 56 888-744-6295 www.sigmaxl.comStatPoint Technologies Inc. 73 800-232-7828 www.statgraphics.comStatSoft Inc. OBC 918-749-1119 www.statsoft.comStrategic Improvement Systems LLC 75 952-380-0778 www.strategicimprovementsystems.comUniversity of Michigan 75 734-647-7200 isd.engin.umich.eduvERSE 77 516-293-0949 www.versesolutions.com

October 2013 • QP

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Page 59: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

Let this product and service guide help you find your way in a sea of options. Whatever solution you’re seeking—training, software,

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ASQ’S QuAlity

ReSouRce Guide

MILWAUKEE SCHOOL OF ENGINEERING

INDUSTRIAL ENGINEERINGFACULTYMilwaukee School of Engineering invites applica� ons for a faculty posi� on at the Assistant or Associate Professor level for Fall 2014 teaching in the Industrial Engineering program within the Mechanical Engineering Department.

This full-� me faculty posi� on requires teaching primarily in the areas of applied sta� s� cs, quality, Six Sigma, and reliability. As a teaching-oriented university, candidates with greater breadth are desired, so secondary areas of interest are opera� ons research, data mining, and Lean manufacturing.

This posi� on requires an earned doctorate in Industrial Engineering (or a related fi eld), relevant industrial experience, and a strong interest in eff ec� ve undergraduate teaching, integra� ng theory, applica� ons and laboratory prac� ce. In addi� on to teaching du� es, the successful candidate will be expected to become involved with academic advising, course/curriculum development, supervision of student projects, and con� nued professional growth through a combina� on of consul� ng, scholarship, and research. Excellent communica� on skills are required. The review of applica� ons will begin as they are received and con� nue un� l the posi� on is fi lled.

Please visit our website at http://www.msoe.edu/hr/ for additional information including requirements and the application process.

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57October 2013 • QP

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Page 60: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

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ABC ISO Consultants 16835-236 Algonquin Street Huntington Beach, CA 92649 Phone: 855-476-9001 www.abcisoconsultants.com

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API IS THE SOURCE FOR SOURCE INSPECTORCERTIFICATIONFollow a new, more rewarding career path by differentiating yourself as a Certified Source Inspector.

API’s new Source Inspector Certification Program recognizes individuals who perform the important task of supplier quality surveillance. These Source Inspectorsexamine fabricated and manufactured equipment and materials at the supplier facility and confirm that these commodities meet the purchaser’s specifications.

Quality surveillance of materials and equipment procured for the oil, natural gas and petrochemical industry provides a higher level of confidence that items purchased meet the minimum requirements specified in the contractual agreementand will function according to design requirements. Utilizing an API-certified SourceInspector will provide an owner/user with the peace of mind that a knowledgeable,industry-qualified individual is representing them.

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61October 2013 • QP

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Page 64: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

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62 QP • www.qualityprogress.com

Company Contact Information

Special Advertising Section

ASQ’S QuAlity

ReSouRce Guide

ASQ 600 N. Plankinton Avenue Milwaukee, WI 53201-3005 Phone: 414-272-8575 www.asq.org

ASQ’s training and education gives you and your organization the best tools to succeed. Its diverse range of learning topics and delivery methods are second to none. Continue your path toward success with ASQ training. Discover a broad range of course offerings from classroom-based learning to Web-based learning. Other: standards.

X X X X X X X X X X X X X X X X

AudIT3 LLC 5 Terrapin Trail Taylors, SC 29687 Phone: 864-498-1120 www.audit3.com

AudIT3 is an accredited registrar of quality and environmental management systems. Our mission is value-added audits, superior customer service and to become a trusted partner.

X X X X X X

BMGI 1200 17th Street, Suite 180 Denver, CO 80202 Phone: 303-827-0010 www.bmgi.com and www.bmgi.org

BMGI is a global consulting firm providing people-driven solutions to your most pressing business problems through innovation, Lean Six Sigma, strategic planning and more. Other: strategic planning and innovation.

X X X X X X X X X X X X X X

BSI 12110 Sunset Hills Road, Suite 200 Reston, VA 20190 Phone: 888-429-6178 www.bsiamerica.com

By packaging assessment, training and a management system software tool, BSI delivers a comprehensive solutions package that provides you with an integrated approach to meet your needs and embed excellence across your business.

X X X X X X X X X X

Page 65: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

63October 2013 • QP

AQS Management Systems, Inc.Your Management Systems Solutions Provider

ISO 9001 | ISO 14001 | ISO 13485 | TS 16949 | ISO 50001OHS 18001 | AS9100 | AS9110 | ISO 22000 | ISO/TS 29001

AQS Management Systems, Inc. provides ISO training, coaching, and project assistance in support of organizational improvement and implementation of international management

system standards. Our primary focus is to provide cost-effective advice and support to organizations who intend to use their completed management system to generate profit and reduce risks for their organization.

AQS Management Systems, Inc.1 9 8 9 – 2 0 1 3

For more information or for additional offerings…Call 763-746-0505 or 1-800-633-2588 or email: [email protected]

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Page 66: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

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64 QP • www.qualityprogress.com

Company Contact Information

Special Advertising Section

ASQ’S QuAlity

ReSouRce Guide

Bureau Veritas Certification 390 Benmar Drive, Suite 100 Houston, TX 77060 Phone: 800-937-9311 www.us.bureauveritas.com/bvc

Founded in 1828, Bureau Veritas is a global leader in certification and verification, helping clients meet challenges in quality, safety, environmental and social responsibility.

X X X X X X

DataNet Quality Systems 29200 Northwestern Highway, Suite 350 Southfield, MI 48034 Phone: 866-4WINSPC www.winspc.com

DataNet Quality Systems delivers real-time quality control software that empowers manufacturers to make the highest quality product for the lowest possible cost.

X X X X X X X X X

DB Performance Solutions LLC 4006 Raymond Avenue Brookfield, IL 60513 Phone: 312-615-3530 www.dbpsllc.us

DBPS deliver internal and supplier audits, CAPA and risk management services to small and midsize businesses for ISO 9001 and 13485. We will guide your training and transition to 9001:2015.

X X X X X X X X X X X X

EMNS Inc. Phone: 888-900-5033 www.gsqa.com

X X X X X

EtQ Inc. 399 Conklin Street, Suite 208 Farmingdale, NY 11735 Phone: 516-293-0949 www.etq.com

EtQ’s quality management software identifies, mitigates, and prevents high-risk events in the quality system. Key functionality includes CAPA, audits, document control, risk register, and more.

X

Huntington Quality Associates Phone: 260-356-6092 www.hqa.com Other: certification preparation, quality system simplification

X X X X X X X

Page 67: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

65October 2013 • QP

BSI Action Manager...powered by EntropyTM Software.

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For 15 years IICT Enterprises LLC (IICT), formerly IICT Training and Productions, has been earning the respect and business of companies (over 900 companies) certi� ed in ISO, AS, NADCAP, FDA, FAA, Nuclear, API and other industries. Our mix of Training in Calibration, Metrology, FDA Inspection Systems, NADCAP, ISO, Pressure, Temperature, Flow, and a wide variety of Quality Control classes enables IICT to partner with a vast cross section of Industry to meet many companies needs relating to Calibration and Quality System requirements. Please view our web site for a complete list of classes (over 85) offered both publicly and on-site.

Our monthly newsletter, Calibration Tips, provides up to date information on Calibration. We have had many compliments from Managers and Engineers who use the information to aid in their Calibration System Management. Contact us at [email protected] for your free reports. Our staf� ng department is available to assist you if you are in need of or desire to make an employment change.

IICT can assist you in Setting Up your Calibration or Quality Department. Email us at [email protected] to receive a personal quote.

For more information on Calibration Training and Calibration Procedures, visit www.iictenterprisesllc.com, or call 612-387-6310 today.

Page 68: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

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66 QP • www.qualityprogress.com

Company Contact Information

Special Advertising Section

ASQ’S QuAlity

ReSouRce Guide

IICT Enterprises LLC 9006 Oakland Avenue S P.O. Box 20623 Bloomington, MN 55420 Phone: 612-387-6310 www.iictenterprisesllc.com

Calibration and metrology workshops! For 15 years IICT Enterprises LLC (IICT), formerly IICT Training and Productions, has earned the respect of more than 900 companies certified in ISO, AS, NADCAP, FDA, FAA, nuclear, API and other industries. Our monthly newsletter, Calibration Tips, provides up-to-date information on calibration. IICT can assist you in setting up your calibration or quality department.

X X X X X X X X X X X X X X X X X X X X

InfinityQS 12601 Fair Lakes Circle, Suite 250 Fairfax, VA 22033 Phone: 703-961-0200 www.infinityqs.com

InfinityQS is the global authority on manufacturing intelligence (MI) and enterprise quality, delivering real-time visibility and actionable insight on the shop floor, across the enterprise and throughout the supply chain.

X X X X X X X

Inmar Inc. 2601 Pilgrim Court Winston-Salem, NC 27106 Phone: 866-440-6917 www.inmar.com

Supported by a continuous investment in technology and lean-focus solutions, Inmar operates three cost-effective networks: supply chain, promotions and healthcare. Our full-service recall management program includes mock recalls, notification, product retrieval, final disposition and Web-based regulatory reporting. With new legislation and increased scrutiny on product safety, manufacturers need to be prepared. Inmar is your end-to-end recall expert.

X X X X X X X

Intelex Technologies 905 King Street W, Suite 600 Toronto, Ontario M6K 3G9 CANADA Phone: 416-599-6009 www.intelex.com

Intelex Technologies has provided software systems for managing environment, health, safety (EHS), quality, and business performance programs since 1992. Our Web-based solutions allow for unprecedented flexibility for managing, tracking and reporting on essential corporate information.

X

Page 69: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

67October 2013 • QP

with Value Stream Mapping

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Page 70: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

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Company Contact Information

Special Advertising Section

ASQ’S QuAlity

ReSouRce Guide

Laboratory Testing Inc. Phone: 800-219-9095 www.labtesting.com

X X X X

Lean & Mean Business Systems Phone: 415-305-4533 www.theleanmachine.com

X

Master Metrology Inc. 1041 Cromwell Bridge Road Towson, MD 21286 Phone: 410-337-0687 www.mastermetrology.com

Single-source calibration services: threads, rings, plugs, mics, blocks, electronics and more. Comprehensive outsourcing solutions: ISO, cGMP, WCM compliant programs. Great prices, fast turnaround, fully accredited.

X X X

Minitab Inc. 1829 Pine Hall Road State College, PA 16801 Phone: 800-448-3555 www.minitab.com

Minitab Inc. delivers software and services for quality improvement. World-class organizations trust Minitab for quality, performance and bottom-line goals.

X X X X X X X X X X X

National Quality Assurance USA Phone: 800-649-5289 www.nqa-usa.com

X X

NC State Lean Six Sigma 1000 Main Campus Drive, Campus Box 8301 Raleigh, NC 27695-8301 Phone: 919-515-0236 www.tx.ncsu.edu/sixsigma

NCSU offers public and on-site Lean Six Sigma training courses. The program includes Executive, Champion, Yellow Belt, Green Belt, Black Belt and Master Black Belt courses. Certification is available.

Sixigma

X X X X X X X X X X X X

Performance Review Institute Registrar 161 Thorn Hill Road Warrendale, PA 15086-7527 Phone: 724-772-1616 www.priregistrar.org

PRI Registrar is a not-for-profit registrar offering certifications in ISO 9001, ISO 14001, AS 9100, AS 9110, AS 9120, AS 9003 and OHSAS 18001 complience audits.

X X X X X

68 QP • www.qualityprogress.com

Page 71: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

69October 2013 • QP

IS YOUR QUALITY CONTROL

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Company Contact Information

Special Advertising Section

ASQ’S QuAlity

ReSouRce Guide

PIVOT Management Consultants/ PQR Group Phone: 877-748-6862 www.pivotmc.com

Other: TRIZ

X X X X X X X

PQ Systems Inc. 210 B East Spring Valley Road Dayton, OH 45458 Phone: 800-777-3020 www.pqsystems.com

PQ Systems provides quality control software and training to help organizations demonstrate proof of their quality performance. Our software solutions include SQCpack®, CHARTrunner® Lean and GAGEpack®.

X X X X X X X

Predisys Inc. 300 Brickstone Square, Suite 201 Andover, MA 01810 Phone: 978-662-5213 www.predisys.com

Predisys is the leading provider of enterprise-class advanced SPC, quality data analytics and quality management software solutions for the intuitive and powerful Microsoft SharePoint and Office platform.

X X X X X X X X X X X X

QI Macros SPC Software for Excel 2696 S. Colorado Boulevard, Suite 555 Denver, CO 80222 Phone: 888-468-1537 www.qimacros.com

You don’t have to be a statistician to start getting immediate results with the QI Macros for Excel! Free 30-day trial: PC or Mac.

X X X X X X X

QiSOFT 2 East Bryan Street, Suite 1515 Savannah, GA 31401 Phone: 912-790-7990 www.qisoft.com

QiSOFT works with manufacturers worldwide to improve profitability by establishing quality as a strategic focus. QiSOFT’s manfacturing intelligence software supports the drive for continuous process and product excellence.

X X X X X

70 QP • www.qualityprogress.com

Page 73: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

71October 2013 • QP

Now you can do both with Quality Essentials Suite,the industry’s surprisingly affordable quality management solution.

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Give us a call at 800-471-1646. Visit our website: www.qualitysolutions.com. Or email us at: [email protected].

Net Promoter Score (NPS) > NPS the of measure customer loyalty • Use it to increase sales • Increase profi tability • Upsell, cross sell, referrals

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Page 74: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

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Company Contact Information

Special Advertising Section

ASQ’S QuAlity

ReSouRce Guide

Quality Essentials Suite 3124 Highway 79 Julian, CA 92036 Phone: 866-949-9504 www.qualityessentialssuite.com

Real-time data collection with centralized data management, including nonconformance, root cause analysis and COA. Improve margins and reduce the cost of quality.

X X X

Quality Horizons LLC 6325 Burchfield Avenue Pittsburgh, PA 15217 Phone: 412-422-2246 www.qualityhorizons.org

Quality Horizons assists organizations to be cost competitive while impoving customer satisfaction. Our signature is to facilitate ideas to implementation.

X X X X X X X X X X X X X X X

Quality Management System PRO LLC Phone: 503-430-1786

Other: corrective action document management

X X X X

Quality Solutions Inc. P.O. Box 40147 Cleveland, OH 44140 Phone: 216-272-5665 www.qualitysolutions.com

Your customer satisfaction survey process tells your customer how important their feedback is to management. Professional online and telephone surveys can be created. Call now for Net Promoter Score® implementation.

X X X X X X X

QualityWBT Center for Education 14 Bald Eagle Road Lake Wylie, SC 29710 Phone: 888-737-4488 www.qualitywbt.org

Since 2000, QualityWBT has been providing courses in auditing, standards familiarization, quality tools, root cause analysis and FMEA. Educational designer: J.P. Russell.

X X X X X X X X X

72 QP • www.qualityprogress.com

Page 75: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

73October 2013 • QP

Education Designer JP Russell

www.QualityWBT.orgtoll free and fax: 888

Offering online courses inAuditing Root Cause AnalysisStandard FamiliarizationQuality ToolsFMEA

Approved by RAB, ASQ, IACET

Education Designer JP Russell

www.QualityWBT.orgtoll free and fax: 888-737-4488

online courses in

Root Cause Analysis Standard Familiarization Quality Tools

Approved by RAB, ASQ, IACET

www.QualityWBT.org

that puts time on your side.Achieve efficiencyStatgraphics® has long provided leading companies and govern-ments worldwide with the software they need for Lean Six Sigma,quality improvement and statistical solutions of every stripe. We arecommitted to making your job easier and your projects successful.

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www.statpoint.com2012 Statpoint Technologies, Inc. All rights reserved. The logo’s and service names mentioned herein are registered

trademarks or trademarks of Statpoint Technologies. Copyright 2012 Statpoint Technologies, Inc.

Statistical Analysis Softwaretraining. consulting. web services.six sigma anova regression spc doe forecasting visualization reliability

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Page 76: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

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Special Advertising Section

ASQ’S QuAlity

ReSouRce Guide

QualiWare 200 Business Park Drive Armonk, NY 10504 Phone: 914-730-7099, x103 www.qualiware.com

QualiWare solutions provide environments for defining, building, managing change to business models, and providing an environment that facilitates quick and efficient response to business change.

X

SigmaXL 920 Yonge Street, Suite 803 Toronto, ON M4W 3C7 Canada Phone: 416-236-5877 www.sigmaxl.com

SigmaXL + Excel = easy statistical and graphical analysis. SigmaXL and DiscoverSim are cost-effective, powerful, user-friendly and ideal for Lean Six Sigma training! Free 30-day trial.

X X X X X X

StatPoint Technologies Inc. 560 Broadview Avenue, Suite 201 Warrenton, VA 20186 Phone: 540-428-0084 www.statgraphics.com

Statgraphics Centurion XVI—make sense of it all. Leading companies worldwide trust Statgraphics statistical software to give voice to their data. Make informed decisions that drive operational efficiencies, ensure quality and preserve precious resources.

X X X X X X

StatSoft Inc. 2300 East 14th Street Tulsa, OK 74104 Phone: 918-749-1119 www.statsoft.com

StatSoft provides award-winning, industry-specific enterprise solutions that integrate analytics with your data repositories for process monitoring, root cause analysis, quality improvement and sophisticated graphical reporting.

X X X X X X X

74 QP • www.qualityprogress.com

Page 77: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

75October 2013 • QP

Strategic Improvement SystemsResearch-Driven Management Consulting

Offering management consulting and training, specializing in strategic improvement.

Charles A. Liedtke, Ph.D.Principal owner of Strategic Improvement Systems, LLC.

For more details, visit www.strategicimprovementsystems.com or call 952-380-0778.

• Strategy• Hoshin Kanri• Data Analytics• Lean Six Sigma

Clients Include:• Manufacturing• Service• Healthcare• Government

• Innovation• Process Management• Change Management

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77October 2013 • QP

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October 2013 • QP 79

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QP • www.qualityprogress.com80

Tell Me About ItExport your lessons learned to spark innovation

The noTion that improvement meth-

ods must and do evolve is not new. In the

November 2010 issue of QP, Ronald Moen

and Clifford Norman examined the history

and evolution of W. Edwards Deming’s

plan-do-study-act (PDSA) improvement

cycle.1 They traced its origins from the

modern scientific method in the 17th

century to inductive reasoning as a means

of generating new knowledge, and then to

the influence of pragmatism and empiri-

cism brought on by the Shewhart cycle

in 1939. Finally, PDSA emerged and it

reflected the importance of learning in

process improvement. The authors con-

cluded, “the PDSA cycle remains relevant

and continues to evolve.”

In 2000, Han van Loon shared his adap-

tation of the Deming cycle in QP. He called

it STARS, which stands for set goals, think,

act, review and supply improvements. Van

Loon said STARS helps employees who

are unfamiliar with PDSA relate continu-

ous improvement to quality management,

and it avoids confusion between the

“do” and “act” steps of

PDSA.2

Years later in QP,

Praveen Gupta

proposed that

the 4Ps—pre-

pare, perform,

perfect and

progress—should

be used to achieve

virtually perfect outputs.

He explained PDSA is only aimed toward

acceptable outputs, not perfection.3

Digital revolutionMethods evolve to satisfy changing needs

and shifting environments. Since the

Deming cycle was updated in the 1990s, in-

formation, videos and people have become

widely accessible online.4 I recommend a

simple, high-impact adjustment to PDSA

to help every quality improvement effort

contribute to the greater good. After the

“act” step is complete, you must export the

lessons learned and the insights gained and

make them available to the world online.

Plan-do-study-act-export (PDSA-X)

supports the collaborative pursuit of

excellence across organizational boundar-

ies, geography and time. It promotes the

emerging concept of social ideation to

stimulate community-driven innovation,

and it links disparate improvement cycles.

Adopting PDSA-X encourages active

reflection on the knowledge you’ll leave

behind for others. If you’re working with

highly proprietary data, you also must

consider the appropriateness of exporting

that information.

PDSA-X Based in part on Moen and Norman’s

outline of PDSA, PDSA-X includes the fol-

lowing steps:

• Plan: Plan a change or test aimed at

improvement.

• Do: Carry out the change (preferably on

a small scale).

• Study: Examine the results. What did

you learn? What went wrong?

• Act: Adopt the change, abandon it or

complete the cycle again.

• Export: Tell your story. Record the

lessons learned online so that others can

benefit from your knowledge and insight.

You may not think that you’ve uncov-

ered something interesting or remarkable,

but someone might at some point. For ex-

ample, I started my blog as an experiment

to see whether anyone would be inter-

ested in my quality-related nuggets. Four

years and tens of thousands of hits later, I

can reliably report the answer is yes.

There are many ways to export your

insights:

• Share your experience at an ASQ sec-

tion meeting.

• Present at the World Conference on

Quality and Improvement or a regional

ASQ conference.

• Post your outcomes on ASQ’s Com-

munities, which are online discussion

boards at http://community.asq.org.

• Publish your findings in a magazine or

journal (find an ASQ publication that

meets your interests at http://asq.org/pub).

• Start a blog (or connect with an ASQ

Influential Voices blogger at http://asq.

org/voice-of-quality and ask about guest

posting).

• Provide comments and answer ques-

tions on blogs and forums.

The beauty of exporting also means

you can become a time traveler. Long after

you’ve forgotten about what you learned

this week, someone on the other side of

the world might find the breadcrumb you

just left behind. QP

RefeRences1. Ronald Moen and Clifford Norman, “Circling Back,” Quality

Progress, November 2010, pp. 22-28.2. Han van Loon, “STARS of Quality Management,” Quality

Progress, September 2000, p. 136.3. Praveen Gupta, “Beyond PDCA—A New Process Manage-

ment Model,” Quality Progress, July 2006, pp. 45-52. 4. Ronald Moen, Thomas Nolan and Lloyd Provost, Improving

Quality Through Planned Experimentation, McGraw-Hill, 1991, p. 11.

NIcolE M. RadzIwIll is an assistant professor at James Madison University in Harrisonburg, Va. She earned a doctorate in technology management and quality systems from Indiana State University in Terre Haute. an aSQ fel-low, Radziwill is an aSQ-certified quality manager and Six Sigma Black Belt.

BAck To BAsIcs BY NiCoLe M. RADziwiLL

Page 83: QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203

Get Involved!

Visit worldqualitymonth.org

WORLD QUALITY MONTH

2013worldqualitymonth.org

November

Highlight Your SuccessA time to show efforts and achievements!

Spread the WordRaise the global voice of quality!

Learn From OthersJoin the celebration!

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