QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the...
Transcript of QUALITY PROGRESS - QMaxima · Quality Progress (ISSN 0033-524X) is published monthly by the...
Qu
ality Pro
gress | o
cto
ber 2013 so
cia
l resPon
sibility Vo
lum
e 46/nu
mber 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
S
S
SS
S5S
Environmental management system reaps results p. 24
Energy-saving approaches p. 32
Plus:
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
www.etq.com/quality800-354-4476 [email protected]
: Integrated modules for Quality and FDA Compliance Management:
CAPA ange Management Risk Assessment ...and more!
Risk Management eventsin t Quality System
Flexible: Leading edg exible work ow adapts to all business processes, wit t programming
: Integrates wit 3rd party business systems
Scalable: Readily adapts to enterprise environments, and deployments
Supplier Management: Collaborates wit rs t roug er
Business Intelligence in decision-making wit reds of con gurable c arts and reports
... st VALUE
nterprise Quality &
CAPAQuality Compliance Software
Receiving
QualityQMS Software
QMS
ISO/TS MRB
DiscreteCalibration
Risk Assessment
Product Data Management
Process
Product Data Management
Corrective Actions
Quality Systems Software
ISO/TS 16949
FMEA
QMS Software
QMS Software
Calibration
TL 9001
TL 9001
CAPA
Process
QualityISO 13485
ISO
ERP
Nonconforming Materials
Discrete
MES
Quality Software
Manufacturing
NCMISO
Quality Assurance
ISO 9000
ISO 9000
ISO 9000
Supplier Rating
ERP
Quality ComplianceManufacturingNonconformance
QMS
CalibrationISO/TS
ISO/TS
Quality Assurance
FMEA
ISO 13485
Quality Management SoftwareCorrective Actions
AS9100
QMS Software
Quality Compliance
CAPAISO Process
PDM
Risk Assessment
FMEA
Manufacturing
Manufacturing
Product Data Management
ISO/TS 16949
ERPCAPA
Quality ComplianceManufacturing
NCM
Nonconforming Materials
ISO 9000DiscreteQuality
CAPAISO/TS Calibration
Quality Software
QualityISO
Discrete
Supplier
PDM
Materials
Inspections
QMS Software
ISO 13485
Quality AssuranceManufacturing
NCMR
Corrective ActionsMRBNonconforming
Nonconforming
Calibration ISO 13485
Calibration
ISO/TSAS9100Compliance
Compliance
Process
Manufacturing
Calibration
FMEA
PDM
ISO/TS
QMS PDM
TL 9001
QMS
QualitySupplier
Quality AssuranceERP
ISO 13485
Quality
ISO 13485AS9100
ISO/TS
CAPAFMEA
Process
Quality
Rating
Inspections
PDM
FMEAISO
Supplier& Materials
Supplier & Materials
Nonconformance
TL 9001
Supplier &
Materials
QMS Software
MaterialsISO/TS
MRB
Receiving Nonconformance
Receiving Inspections
Product DataManagement
Process
QMS
Membership ApplicationOFFICE USE ONLY
PRIORITY CODE _______________________
Order Number ________________________
Member Number ______________________
❑ Audit (19)❑ Automotive (3)❑ Aviation, Space and Defense (2)❑ Biomedical (10) ❑ Chemical and Process Industries (4)❑ Customer-Supplier (15) ❑ Design and Construction (20)❑ Education (21)❑ Electronics and Communications (5) ❑ Energy and Environmental (11)❑ Food, Drug, and Cosmetic (7)❑ Government (22)❑ Healthcare (18)
❑ Human Development and Leadership (13)❑ Inspection (9) ❑ Lean Enterprise (23) ❑ Measurement Quality (17) ❑ Product Safety and Liability Prevention (25)❑ Quality Management (1)❑ Reliability (8)❑ Service Quality (16) ❑ Six Sigma (26)❑ Software (14)❑ Statistics (12)❑ Team & Workplace Excellence (27)
❑ Accountant❑ Administrator❑ Advisor❑ Analyst❑ Associate❑ Auditor❑ CEO ❑ Chemist❑ Clinician❑ Consultant
❑ Contractor❑ Controller/ Comptroller❑ Coordinator❑ Director❑ Engineer❑ Facilitator❑ Foreman❑ General Manager
❑ Inspector❑ Instructor❑ Machinist❑ Manager❑ Mechanic❑ Nurse❑ Owner❑ Physician❑ President❑ Principal
❑ Professor❑ Programmer❑ Retired❑ Scientist❑ Six Sigma Black Belt❑ Six Sigma Green Belt❑ Specialist❑ Statistician
❑ Student❑ Superintendent❑ Teacher❑ Technician❑ Unemployed❑ Other
Which one of the following best describes your title?
ASQ does not sell email addresses to third parties.
Mailing Lists❑ Occasionally ASQ shares its mailing list with carefully selected quality-related organizations to provide you with information on products and services. Please check this circle if you do not wish to receive these mailings.
Member Referred By:
_____________________________________ _______________________ Member Name Member Number
Payment Information❑ Check or money order (U.S. dollars drawn on a U.S. bank) Make check payable to ASQ.
❑ MasterCard ❑ Visa ❑ American Express (Check one)
____________________________________________________________________ Cardholder’s Name (please print)
______________________________________________ ___________________ Card Number Exp. Date
______________________________________________ Cardholder’s Signature
____________________________________________________________________ Cardholder’s Address
MBKDF32
1
2
3
Preferred Mailing Address: ❑ Home ❑ Business
❑ Mr. ❑ Ms. ❑ Mrs. ❑ Dr. ❑ Male ❑ Female
Date of Birth _________________________________
____________________________________________________________________ First Name Middle Initial Last Name/Family Name
____________________________________________________________________ Company Name Job Title
____________________________________________________________________ Business Address Ste.
____________________________________________________________________ City, State/Province Zip+4/Postal Code Country
____________________________________________________________________ Home Address Apt./Ste.
____________________________________________________________________ City, State/Province Zip+4/Postal Code Country
____________________________________________________________________Area Code/Business Telephone Area Code/Home Telephone
____________________________________________________________________ Preferred Email Address Fax
Member Type: ❑ Full $143 ❑ Associate $85 $ __________________
The one geographic Section included with Full membership will be determined by your primary address.* Sections (geographic) may be added to any member type for an additional $20.00 each. Visit www.asq.org for a listing of available Sections. Sections cccc , cccc , cccc $_______
Contact ASQ to change your assigned Section.
Forum or Division SelectionAs part of your Full membership you receive participation in one topic- or industry-specific Forum or Division. Use the list below to indicate the Forum or Division number and name. _____ ______________________ $_____________ (#) Name Additional Forums and Divisions may be added to all levels of membership.Please indicate in the list below the additional Forums or Divisions you would like and total the number you have selected.
❑ Healthcare ❑ Government❑ Manufacturing
Industry: ❑ Service ❑ Education
Total of all items (1-3): $ _________Please submit your application with remittance to:
New memberships are effective upon receipt of payment. New members receive one year of membership from the date they join. Members are billed prior to the anniversary date of their membership for next year’s dues. Memberships, even those paid by employers, are nontransferable. All prices are subject to change.
In becoming an ASQ member, you have the duty to follow the ASQ Code of Ethics and Society governing documents.
You may also join online at www.asq.org or by calling ASQ Customer Care at
USA and Canada: 800-248-1946Mexico: 001-800-514-1564
All other locations: +1-414-272-8575
ASQ P.O. Box 3066 Milwaukee, WI 53201-3066 USA or fax to 414-272-1734.
included
Additional Forum and Division selections:Full or Associate member ________ x $10 = $________________________
total
/ / M D Y
To help us understand what’s important to you, please tell us the top three reasons why you became an ASQ member.
❑ Career Development ❑ Certification Pricing ❑ In-person Networking ❑ Involvement in ASQ’s Cause ❑ Involvement in SRO ❑ Knowledge/Information ❑ Leadership Opportunities ❑ Online Networking/Communities ❑ Product Discounts ❑ Training
WHY DID YOU JOIN?
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
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
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
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
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.
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.
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
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.
QUALITY COUNCIL OF INDIANA
Our Primers contain study material for the current ASQ bodies of knowledge plus sample questions and answers. The Primers may be taken into the exam. The completeness of our materials makes them themostwidelyusedtextsforCertificationTraining.
CQIAPRIMER
C
CSSBBPRIMER
C
CQEPRIMER
C
CQTPRIMER
C
CSQEPRIMER
C
CBAPRIMER
C
CREPRIMER
C
CMQPRIMER
CQIPRIMER
C
CCTPRIMER
C
CQAPRIMER
C
CQPAPRIMER
C
CSSGBPRIMER
CC
PRIMERSNew CBA
SOLUTION TEXTSQuality Council of Indiana offers detailed solutions to all questions presented in the corresponding Primer.
CD-ROMSQCI offers user-friendly interactive software to assist students preparing for ASQ examinations. Each CD contains 1000 total questions. Examinationsaretimedandsummarizedgraphically.Ahelpfileprovidesexplanations and references. The CDs run on Windows XP and newer.
Mail OrdersQuality Council
of IndianaOrder Department602 W. Paris Ave.
W. Terre Haute, IN 47885-1124
CQE
CQA
CSSGB
Information812-533-4215
Telephone Orders800-660-4215Internet Orders
www.qualitycouncil.com
Fax Orders812-533-4216
Juran’s Quality Handbook Implementing Six Sigma The Quality Technician’s Handbookby Juran & De FeoThe essential quality reference for most ASQ exams
by Forrest W. Breyfogle, IIIA great CSSBB reference
by Gary K. GriffithGreat for CQT and CQI exams.
LSS PrimerThe Lean Six Sigma Primer is written to a QCI BoK. There are more case studies and lean content than in any other QCI products. 400 questions are included. A solution text is also available.
RAM Dictionary
ISO 9001 InternalAuditing Primer
SpanishGreen Belt
ISO Primer
Quality SystemHandbook
by Tracy OmdahlMore than 2500 definitions. Great for any ASQ certification.
by Tracy OmdahlContains 2800 definitions. Helpful for Reliability and Quality Engineers.
by Bensley & WortmanPresents a thorough treatment of the ISO implementation and documentation process. There are generic manuals on the CD.
by Edenborough Details the selection, organization, and writing of quality documents. The disk contains procedures and work instructions.
by Greg Wies & Bert ScaliA convenient book for training internal auditors to the ISO 9001 expectations.An instructor CD is available.
The Spanish version of the CSSGB Primer.
Reliability & MaintenanceAnalyst CD
Measurement Analyst CD
by Bryan DodsonSolve your Weibull, reliability, warranty, Bayesian & Maintenance, prediction & estimation problems.
Performs all measurements required in the AIAG manual. Contains ANOVA methods and excellent graphs.
QualityDictionary
En Español
CSSGBPRIMER
ISO
QSHSite and global license available!!!
Used by Chrysler, ITT, FedEx, Ford, TRW, GM, HP, U.S. Postal Service
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
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).
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.
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
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.
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
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.
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
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
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
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.
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.
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
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.
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
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
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
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
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
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
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
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.
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.
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
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
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.
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.
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
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
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.
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.
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
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
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.
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
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.
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.
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
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.
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
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
•
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].
•
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
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
Let this product and service guide help you find your way in a sea of options. Whatever solution you’re seeking—training, software,
audits, quality programs—this guide gives you
information you need to make sound decisions and
conduct the research that will lead you to the best
provider for your needs.
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.
MSOE IS AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER
Resource Advantage, Inc.Applying Collaborative Techniques to Improve Business Results
We bring expertise in Facilitation and Collaborative Techniques applied in the context of your business to enable your teams to achieve more - improving business processes and defining the right supporting people and technology capabilities.
Industry Expertise includes:• Manufacturing• Financial Services• Utilities
• Direct Marketing• Healthcare
www.resourceadvantageinc.com
284 Ford RoadMelrose, NY 12121+1.518.663.5232
We believe companies thrive when People, Process, and Technology are aligned. Quality is not just about the Products and Services you produce, but “how” those Products and Services are developed, brought to market, and supported.
4 Results = improved quality, speed to market, and sustainability of support.
57October 2013 • QP
Special Advertising Section
BALD
RIG
E AS
SESS
MEN
TcA
REER
STA
ffIN
GcE
RTIf
IcAT
ION
cON
TIN
UIN
G E
DUc
ATIO
NcU
STO
MER
SAT
ISfA
cTIO
NE-
LEAR
NIN
GfM
EALE
ANM
ETRO
LOG
YO
NSI
TEPU
BLIc
TRA
ININ
GQ
UALI
TY A
UDIT
SQ
UALI
TY T
OO
LS &
MUL
TIM
EDIA
QUA
LITY
TRA
ININ
GRE
cALL
MAN
AGEM
ENT
SELf
-DIR
EcTE
D L
EARN
ING
SIX
SIG
MA
SOfT
WAR
ESP
c
STAN
DAR
DS
REG
ISTR
ARS
STAN
DAR
DS
TRAI
NIN
GTE
STIN
G L
ABO
THER
58 QP • www.qualityprogress.com
Company Contact Information
Special Advertising Section
ASQ’S QuAlity
ReSouRce Guide
ABC ISO Consultants 16835-236 Algonquin Street Huntington Beach, CA 92649 Phone: 855-476-9001 www.abcisoconsultants.com
Professional services for implementation, training and continual improvement of international management systems. Publisher of QMSCAPATM management system software, the single user version is licensed free.
X X X X X X X X X
ABS Quality Evaluations 16855 Northchase Drive Houston, TX 77060 Phone: 281-673-2800 www.abs-qe.com
ABS Quality Evaluations is a management system auditing and certification body that offers third-party certification services, first- and second-party (supplier) assessments and training. Other: standards.
X X X X X
AIAG 26200 Lahser Road, Suite 200 Southfield MI 48033 Phone: 248-358-3003 www.aiag.org
AIAG is where OEMs, suppliers and academia work collaboratively to decrease costs and complexity from the supply chain via global standards development and harmonized business practices.
X X X X X X X X
Alpha Training and Consulting 8634 Acorn Lane Sandy, UT 84093 Phone: 801-942-9274 www.alphaTC.com
Alpha Training and Consulting is a full-service quality consulting firm. The largest sectors of our business include Six Sigma training, consulting and ISO implementation.
X X X X X X X X X X X X X X X X X X X X
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.
For more information visit www.api.org/si or email [email protected].
Copyright 2013 – American Petroleum Institute, all rights reserved. API, ICP, the API logo, the ICP logo and the “Career advancement” slogan are either trademarks or registered trademarks of API in the United States and/or other countries.
Career advancement is spelled ICP
Scan me for more info.
SM
QualityResGuide_SIAd_October_Layout 1 6/26/13 11:33 AM Page 1
BALD
RIG
E AS
SESS
MEN
TcA
REER
STA
ffIN
GcE
RTIf
IcAT
ION
cON
TIN
UIN
G E
DUc
ATIO
NcU
STO
MER
SAT
ISfA
cTIO
NE-
LEAR
NIN
GfM
EALE
ANM
ETRO
LOG
YO
NSI
TEPU
BLIc
TRA
ININ
GQ
UALI
TY A
UDIT
SQ
UALI
TY T
OO
LS &
MUL
TIM
EDIA
QUA
LITY
TRA
ININ
GRE
cALL
MAN
AGEM
ENT
SELf
-DIR
EcTE
D L
EARN
ING
SIX
SIG
MA
SOfT
WAR
ESP
c
STAN
DAR
DS
REG
ISTR
ARS
STAN
DAR
DS
TRAI
NIN
GTE
STIN
G L
ABO
THER
60 QP • www.qualityprogress.com
Company Contact Information
Special Advertising Section
ASQ’S QuAlity
ReSouRce Guide
American Association for Laboratory Accreditation (A2LA) 5301 Buckeystown Pike, Suite 350 Frederick, MD 21704 Phone: 301-644-3248 www.a2la.org
A2LA offers accreditation to and training on ISO/IEC 17025, ISO/IEC 17020, ISO Guide 34, ISO/IEC 17065, ISO/IEC 17043 and ISO 15189.
X X X X X X
American Petroleum Institute 1220 L Street, NW Washington, DC 20005 Phone: 202-682-8165 www.api.org
The American Petroleum Institute is the leading provider of certificaion for the oil and natural gas industry. API-certified personnel are recognized around the world.
X X X X X X
ANSI-ASQ National Accreditation Board 600 N. Plankinton Avenue, Suite 300 Milwaukee, WI 53203 Phone: 800-606-5394 www.anab-aclass.org
Providing accreditation to ISO and industry standards for management systems; calibration, test, and forensic laboratories; inspections bodies; PT providers; Ramp’s; police forensic agencies; and medical examiners. Other: accreditation.
X X
AQS Management Systems 2167 Northdale Boulevard NW Minneapolis, MN 55433 Phone: 763-746-0505 www.aqsperformance.com
AQS Management Systems provides ISO training, coaching and project assistance in support of the organizational improvement and implementation of international management system standards.
X X X X X X
61October 2013 • QP
Let us pave your way throughthe ISO Maze to Certification
abcisoconsultants.com
ISO14001
855.ISO.9001
Supply Chain Audits
AS9100ISO9001
Internal Audits
ISO18001
855.476.9001
© Access Business Communications, Inc.
ISO27001
ProfessionalServices
International Management Systems
we wrote
THE
The OriginalResource for Standards & Best PracticesPublications • Training • Certifications
#AIAG
APQP, PPAP, MSA, SPC, ISO/TS 16949Problem Solving, Materials Management,and more.
we wrote
THETHETHETHEBOOKon QUALITY.
BALD
RIG
E AS
SESS
MEN
TcA
REER
STA
ffIN
GcE
RTIf
IcAT
ION
cON
TIN
UIN
G E
DUc
ATIO
NcU
STO
MER
SAT
ISfA
cTIO
NE-
LEAR
NIN
GfM
EALE
ANM
ETRO
LOG
YO
NSI
TEPU
BLIc
TRA
ININ
GQ
UALI
TY A
UDIT
SQ
UALI
TY T
OO
LS &
MUL
TIM
EDIA
QUA
LITY
TRA
ININ
GRE
cALL
MAN
AGEM
ENT
SELf
-DIR
EcTE
D L
EARN
ING
SIX
SIG
MA
SOfT
WAR
ESP
c
STAN
DAR
DS
REG
ISTR
ARS
STAN
DAR
DS
TRAI
NIN
GTE
STIN
G L
ABO
THER
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
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]
w w w. a q s p e r f o r m a n c e . c o m
The leader in RABQSA Certified
Training
BALD
RIG
E AS
SESS
MEN
TcA
REER
STA
ffIN
GcE
RTIf
IcAT
ION
cON
TIN
UIN
G E
DUc
ATIO
NcU
STO
MER
SAT
ISfA
cTIO
NE-
LEAR
NIN
GfM
EALE
ANM
ETRO
LOG
YO
NSI
TEPU
BLIc
TRA
ININ
GQ
UALI
TY A
UDIT
SQ
UALI
TY T
OO
LS &
MUL
TIM
EDIA
QUA
LITY
TRA
ININ
GRE
cALL
MAN
AGEM
ENT
SELf
-DIR
EcTE
D L
EARN
ING
SIX
SIG
MA
SOfT
WAR
ESP
c
STAN
DAR
DS
REG
ISTR
ARS
STAN
DAR
DS
TRAI
NIN
GTE
STIN
G L
ABO
THER
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
65October 2013 • QP
BSI Action Manager...powered by EntropyTM Software.
Do you find that you are faced with the following challenges?• Recurring issues: difficulties addressing root cause
• Out of date information: trapped in spreadsheets and emails
• Inconsistent data collection: ineffective compliance between people, departments, locations
• Lack of visibility: which actions are in process,closed, or overdue
• Missed deadlines: actions are not closed out in a timely manner
• Overly manual processes: inefficient resources
• Manage all of your findings in one place
• Facilitate faster close-out of actions
• Gain visibility into operations
• Enhance task management
• Bring confidence to compliance
A new business improvement tool from BSI starting at $100 per month!
1 888 429 6178 I [email protected] I www.bsi-entropy.com/ActionManager
US_Action_Ad_8.13-2_Layout 1 8/5/13 12:34 PM Page 1
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.
BALD
RIG
E AS
SESS
MEN
TcA
REER
STA
ffIN
GcE
RTIf
IcAT
ION
cON
TIN
UIN
G E
DUc
ATIO
NcU
STO
MER
SAT
ISfA
cTIO
NE-
LEAR
NIN
GfM
EALE
ANM
ETRO
LOG
YO
NSI
TEPU
BLIc
TRA
ININ
GQ
UALI
TY A
UDIT
SQ
UALI
TY T
OO
LS &
MUL
TIM
EDIA
QUA
LITY
TRA
ININ
GRE
cALL
MAN
AGEM
ENT
SELf
-DIR
EcTE
D L
EARN
ING
SIX
SIG
MA
SOfT
WAR
ESP
c
STAN
DAR
DS
REG
ISTR
ARS
STAN
DAR
DS
TRAI
NIN
GTE
STIN
G L
ABO
THER
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
67October 2013 • QP
with Value Stream Mapping
www.qualitycompanion.com
Once you see it, you can improve it.
QualityProgress_HalfPage_08-13.indd 1 8/8/2013 11:47:02 AM
Software solutions for achieving your quality goals.
SPCSoftware
GageManagement
Software
Visit us at www.pqsystems.com or call us at 800-777-3020 for more information.
Proof of quality.™
BALD
RIG
E AS
SESS
MEN
TcA
REER
STA
ffIN
GcE
RTIf
IcAT
ION
cON
TIN
UIN
G E
DUc
ATIO
NcU
STO
MER
SAT
ISfA
cTIO
NE-
LEAR
NIN
GfM
EALE
ANM
ETRO
LOG
YO
NSI
TEPU
BLIc
TRA
ININ
GQ
UALI
TY A
UDIT
SQ
UALI
TY T
OO
LS &
MUL
TIM
EDIA
QUA
LITY
TRA
ININ
GRE
cALL
MAN
AGEM
ENT
SELf
-DIR
EcTE
D L
EARN
ING
SIX
SIG
MA
SOfT
WAR
ESP
c
STAN
DAR
DS
REG
ISTR
ARS
STAN
DAR
DS
TRAI
NIN
GTE
STIN
G L
ABO
THER
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
69October 2013 • QP
IS YOUR QUALITY CONTROL
SOLUTION READY TO MEET
TODAY’S CHALLENGES?
Enterprise Quality PortalThe modular Predisys suite features a richset of powerful applications, including: • Advanced SPC • Quality Data Analytics • Real Time Data Collection • Centralized Data Management • Batch History Records
Empower Your UsersPredisys Analytical Suite is the world’s most intuitive and easy-to-use Quality Control solution. It provides instant access to the information needed to understand, improve and control any process.
Impress Your IT DepartmentThe powerful and IT-friendly solution for• Microsoft Windows• Microsoft SharePoint• Microsoft Reporting Services• Microsoft Office
[email protected] • (978) 662-5213 • www.predisys.com
ASQ 1/2 pg Ad_Layout 1 8/8/13 12:03 PM Page 1
BALD
RIG
E AS
SESS
MEN
TcA
REER
STA
ffIN
GcE
RTIf
IcAT
ION
cON
TIN
UIN
G E
DUc
ATIO
NcU
STO
MER
SAT
ISfA
cTIO
NE-
LEAR
NIN
GfM
EALE
ANM
ETRO
LOG
YO
NSI
TEPU
BLIc
TRA
ININ
GQ
UALI
TY A
UDIT
SQ
UALI
TY T
OO
LS &
MUL
TIM
EDIA
QUA
LITY
TRA
ININ
GRE
cALL
MAN
AGEM
ENT
SELf
-DIR
EcTE
D L
EARN
ING
SIX
SIG
MA
SOfT
WAR
ESP
c
STAN
DAR
DS
REG
ISTR
ARS
STAN
DAR
DS
TRAI
NIN
GTE
STIN
G L
ABO
THER
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
71October 2013 • QP
Now you can do both with Quality Essentials Suite,the industry’s surprisingly affordable quality management solution.
Call us today to discover how to change your business profitability and eliminate the paper based visibility gap with our unlimited user license solution.
Reduce expenses, produce fewer bad products.
Quality Results begin with Quality Solutions, Inc.
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
> NPS Methodology • More than a score • Develop infrastructure • Touchpoint analysis • Integrate with KPIs • Survey design support, training & management consulting
> NPS - Performance Reporting • NPS Dashboard tools • Identify areas for immediate attention • Advanced statistical analysis
Professional Market Research
> Customer Satisfaction Surveys • Online • Telephone • Mail
> Transaction & Relationship Surveys • Transaction: Event Driven • Relationship: Strategic • Competitive Analysis
> On-Line Survey SolutionsTM • Turnkey solutions – Custom designed • Hosting services, cross tabulation • Advanced statistical analysis • Detailed reports and instant analysis
> Employee Satisfaction Surveys • NPS Cultural Index • Custom surveys to assess operating culture
BALD
RIG
E AS
SESS
MEN
TcA
REER
STA
ffIN
GcE
RTIf
IcAT
ION
cON
TIN
UIN
G E
DUc
ATIO
NcU
STO
MER
SAT
ISfA
cTIO
NE-
LEAR
NIN
GfM
EALE
ANM
ETRO
LOG
YO
NSI
TEPU
BLIc
TRA
ININ
GQ
UALI
TY A
UDIT
SQ
UALI
TY T
OO
LS &
MUL
TIM
EDIA
QUA
LITY
TRA
ININ
GRE
cALL
MAN
AGEM
ENT
SELf
-DIR
EcTE
D L
EARN
ING
SIX
SIG
MA
SOfT
WAR
ESP
c
STAN
DAR
DS
REG
ISTR
ARS
STAN
DAR
DS
TRAI
NIN
GTE
STIN
G L
ABO
THER
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
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.
Take control of your business. Make sense of it all with the respectedstatistical data analysis solutions from Statgraphics.
Statgraphics Centurion I Sigma express, a DMAIC for Microsoft Excel I Statbeans Java Library
Statgraphics .Net Services I Statgraphics Online for ipad and beyond…
Training I Consulting
Learn more, find a local representative or download a free copy to evaluate andbegin improving your business at:
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
Good Ad.new brown2_Layout 1 9/10/12 3:44 PM Page 1
BALD
RIG
E AS
SESS
MEN
TcA
REER
STA
ffIN
GcE
RTIf
IcAT
ION
cON
TIN
UIN
G E
DUc
ATIO
NcU
STO
MER
SAT
ISfA
cTIO
NE-
LEAR
NIN
GfM
EALE
ANM
ETRO
LOG
YO
NSI
TEPU
BLIc
TRA
ININ
GQ
UALI
TY A
UDIT
SQ
UALI
TY T
OO
LS &
MUL
TIM
EDIA
QUA
LITY
TRA
ININ
GRE
cALL
MAN
AGEM
ENT
SELf
-DIR
EcTE
D L
EARN
ING
SIX
SIG
MA
SOfT
WAR
ESP
c
STAN
DAR
DS
REG
ISTR
ARS
STAN
DAR
DS
TRAI
NIN
GTE
STIN
G L
ABO
THER
Company Contact Information
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
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
Strategic Areas:
power your workforce with education from the leaders and best
Lean Certifi cates and Six Sigma Quality Certifi cations� e University of Michigan off ers a full suite of Six Sigma and Lean courses. We have the expertise and resources to meet your group’s specifi c needs online, in the classroom, or with a custom off ering.
Six Sigma Green Belt and Black Belt Certifi cations: Manufacturing Transactional Healthcare Lean-Six Sigma Design for Six Sigma
Register Online Today: isd.engin.umich.edu
Lean Certifi cates: Lean Manufacturing Lean Healthcare Lean Offi ce Lean Product Development Lean Supply Chain for Healthcare
Lean Management: Improvement and Coaching Kata
BALD
RIG
E AS
SESS
MEN
TcA
REER
STA
ffIN
GcE
RTIf
IcAT
ION
cON
TIN
UIN
G E
DUc
ATIO
NcU
STO
MER
SAT
ISfA
cTIO
NE-
LEAR
NIN
GfM
EALE
ANM
ETRO
LOG
YO
NSI
TEPU
BLIc
TRA
ININ
GQ
UALI
TY A
UDIT
SQ
UALI
TY T
OO
LS &
MUL
TIM
EDIA
QUA
LITY
TRA
ININ
GRE
cALL
MAN
AGEM
ENT
SELf
-DIR
EcTE
D L
EARN
ING
SIX
SIG
MA
SOfT
WAR
ESP
c
STAN
DAR
DS
REG
ISTR
ARS
STAN
DAR
DS
TRAI
NIN
GTE
STIN
G L
ABO
THER
Company Contact Information
Special Advertising Section
ASQ’S QuAlity
ReSouRce Guide
Strategic Improvement Systems LLC 6231 Hummingbird Road Excelsior, MN 55331-8884 Phone: 952-380-0778 www.strategicimprovementsystems.com
Management consulting and training specializing in strategy, Hoshin Kanri, analytics, Lean Six Sigma and innovation. Clients: Fortune 500, privately held, state government, manufacturing, service and healthcare.
X X X X X
Sustaining Edge Solutions Inc. 8055 N. Branch Drive Tucson, AZ 85743-9642 Phone: 888-572-9642 www.sustainingedge.com
Since 2002, providing complete systems that enhance operational and customer satisfaction through process improvement, cost reduction and waste elimination. Other: kaizen events.
X X X X X X X X X X X X X X X
University of Michigan Integrative Systems + Design 2401 Plymouth Road, Suite A/B Ann Arbor, MI 48105-2193 Phone: 734-647-7200 isd.engin.umich.edu
The University of Michigan’s Division of Integrative Systems + Design offers lean and Six Sigma certifications, custom programs, and online and on-campus master’s degrees.
X X X X X X X X X
USC Consulting Group Phone: 800-888-8872 www.usccg.com
X X X X X X X X X
VERSE 399 Conklin Street, Suite 208 Farmingdale, NY 11735 Phone: 516-293-0949 www.versesolutions.com
VERSE provides key quality processes such as document control, corrective action, audits, training and risk management—all in a dedicated cloud environment.
X
76 QP • www.qualityprogress.com
77October 2013 • QP
2013 NATIONAL QUALITY EDUCATION CONFERENCE CREATIVITY AND INNOVATION: KEYS TO 21ST CENTURY LEARNING November 17 – 18, 2013 | Milwaukee, WI | nqec.asq.org
ASQ’s 2013 National Quality Education Conference will demonstrate—no matter the grade level—how creativity and innovation complement continuous improvement by focusing on teamwork, solutions, and the learner through the following:
• More than 30 concurrent sessions meet your learning needs • Half-day preconference hands-on workshops to advance your skills • Real-life examples at the Education Team Excellence Recognition
Award sessions • Renowned keynote speakers to share their experience and
best practices • Networking with hundreds of educators and leaders focused on
building quality schools
Early-bird pricing is available through October 14, 2013.
To register for the 2013 National Quality Education Conference, visit nqec.asq.org.
QP • www.qualityprogress.com78
Professionalservicesfor information on placing an ad, contact Media sales at 866-277-5666.
Quality Institute of America, Inc.Since 1994
Complete Quality, Environmental, Safety, Six Sigma, Consulting, Auditing, and
Training Services. Comprehensive Quality Management Software (QISS).
• QISS-based ISO-Easy Program • Quality Management Software (QISS)
Automating Document and Records Control, Communications, Nonconformance, Corrective-Preventive Actions, Calibration, Maintenance, Training, Audits, and Management Reviews.
PH: 281-335-7979. Houston, TX Email: [email protected], www.qi-a.com www.qisssoftware.com
www.sixsigmatraining.org /store+1 520-204-1957
Lean Six Sigma Trainingand certification online by
Thomas Pyzdek
Save 10%! Enter coupon code ASQ10 at checkout
Classroom Training Aids…g Quincunx Boardsg Sampling Bowlsg Catapults g Deming Funnelsg And lots more …
Visit us at: www.qualitytng.comEmail [email protected] for brochure
Ph: 248-641-7030 Fax: 248-641-7031PO Box 611 Troy, MI 48099-0611
IMDS Data• We can create your data and submit within
72 hours• We do the work and invoice you• References found on our website• Based in the United States
www.imdsdata.org • 734-205-8874
TQM AssociATes inc.“we’re here to support you”
• established in 1994• Women-owned
• Quality Assurance Professionals• Across the U.s. and Worldwide
• Temporary or Permanent• source inspection
• surveys• Audits
• expediting
800-424-4729 3990 old Town Ave. #c109Fax 619-297-3251 san Diego, cA 92110tqmassociates.com email: [email protected]
Recognized industry leader in rapidly expanding registration industry is seeking a highly motivated quality professional to join our organization as a Lead Auditor.
ISO 9001 • AS9100 • TL 9000 • ISO 14001 • RC 14001 • OHSAS 18001
22375 Broderick Drive, Suite 160 Sterling, VA 20166
Phone: 703-478-0241 • Fax: 703-478-0645 www.qsr.com
Quality Systems Registrars, Inc.
Beijing Enertic Engineering Technical Co., Ltd.A 3rd party inspection company
10 years’ experience for boiler, steel structure, pipes, pumps, valves, etc. in China and Asia.
China Headquarters: Tel: +86-1350-023-1596 Email: [email protected]
US representative: Tel: 843-810-4805Email: [email protected]
Website: www.enertic.com
Consulting on Reliability, Risk Management, and Quality
www.HaibelConsulting.com (425) 458-0202
eAudits.orgLearn how to conduct audits remotely.
Looking for Quality Professionals?Place a Recruitment Ad in
Quality Progress and reach more than 100,000 readers from all over the world!
Contact Media Sales at 866-277-5666.
October 2013 • QP 79
Professionalservicesfor information on placing an ad, contact Media sales at 866-277-5666.
For Accredited Certification Look for the Symbols of Quality
Highest Ranked Registrar in an independent customer survey!
EAGLE Registrations Inc. EAGLE Food Registrations Inc.
ISO 9001 · AS 9100 · ISO/TS 16949 ISO 14001 · ISO 13485 · OHSAS 18001
Safe Quality Food (SQF) · ISO 22000 FSSC 22000 · SQF Ethical Sourcing
Call 800-795-3641 | www.eagleregistrations.com
ISO 9001, AS 9100, ISO 13485, ISO 20000 FDA QSR, Canadian MDR, European MDD Planning, Implementation, Training Process Improvements, Process Validation QMS Internal Audits, Mini-audits
Camille Delmotte, MBA, President Phone and fax: 410-426-2269 [email protected]
www.QualityEdgeConsulting.com
2014 LEAN ANDSIX SIGMA CONFERENCESUSTAINING RESULTS THROUGH A CULTURE OF QUALITY February 24 – 25, 2014 | Phoenix, AZ | sixsigma.asq.org
No matter your industry, if you are just starting to discover lean and Six Sigma or a seasoned veteran, the 2014 Lean and Six Sigma Conference will show you how to apply lean and Six Sigma tools and methodologies, and the steps taken to sustain those results to make a difference in your organization.
Enjoy more than 50 sessions, hands-on workshops, keynote speakers, and networking opportunities to make a difference in your career and organization.
Find out more information about the 2014 Lean and Six Sigma Conference at sixsigma.asq.org.
Hands-On Root Cause Analysis Training/Coaching!
• Four Hours of Training, then …• Hands-On Application w/Teams …• On Your Toughest Problems!!• Outputs—Solutions and Actions• Guaranteed results!
Mike MicklewrightCSSBB, CQMgr, CQA, CQEArlington Heights, ILPH: [email protected]; www.mikemick.com
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
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!
• 2300 East 14 Street • Tulsa, OK 74104 • USA • +1 (918) 749-1119 • •