Issue ABRIL 2013.pdf

8/10/2019 Issue ABRIL 2013.pdf

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

QUALITY PROGRESS

P

Plus:

Corral your documentsand data p. 22

Team up to improveefciency p. 28

Find rmer footingwith a well-balanceddata managementplan p. 16

ManagingRisk

Get Emotional:

Get Emotional: Understand Its Role

In the Workplacep. 34


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Once you see it, you can improve it.

with Value Stream Mapping

www.qualitycompanion.com


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The ASQ Global State of Quality Research is the rst comprehensive view of quality

and continuous improvement worldwide. The initial report will be unveiled at the 2013

World Conference on Quality and Improvement in Indianapolis, IN, May 6-8, 2013.

The report reveals benchmark data gathered from 2,000 organizations in 22 countries,

and can help you assess your quality management advancements compared to other

organizations in your region, industry, and economic sector.

The unveiling takes place during a session on Tuesday, May 7, 2013 at 4 p.m.

Afterward, the report will be available for downloadonline at asq.org/research.

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

ContentsFEATURES

Hearing Aid Listen to the authors of

Balancing Act (pp. 16-21)discuss the importance ofbetter quality data management.Also read two exclusive onlinesidebars that expand on thismonths cover article.

More From Thor Two additional tables containingcorrelation and regressionresults from the study onemotional intelligence andwork engagement, thesubject of Scott ThorsMood Righting(pp. 34-40).

Read All About It Get the latest Quality News

Today headlines.

Popularity Contest Check out what QP readershave clicked on most often.

www.qualityprogress.comONLY @

DATA MANAGEMENTBalancing ActBetter management of quality data can help organizations identifycontinuous improvement opportunities, reduce risk and improveproduct quality.

by Eda Ross Montgomery and Justin Neway

Avoiding an AvalancheLessen liability and reduce risk by getting a better handle ondata and documents within your quality management system.

by Greg Milliken

PROCESS IMPROVEMENTWhat Makes You Tick?Break up operational logjams within your organizationto boost business performance and better serve customers.

by H.F. Ken Machado

EMOTIONAL INTELLIGENCEMood RightingHigh levels of emotional intelligence create a workforce thatis more engaged, dedicated and productive, a recent study reveals.

by Scott Thor

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28

34

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QP www.qualityprogress.com

LogOn Sustaining lean Six Sigma

project results.

Expert Answers How an IT rm advanced with

lean Six Sigma.

Keeping Current Lessons from the Lululemon recall. Statistics pioneer Box passes away.

Mr. Pareto Head

QP Toolbox

QP Reviews

DEPARTMENTS

Up FrontData disarray.

Innovation ImperativeControlling risk within theinnovation process.

Quality in theFirst PersonThe mistake of managingwith an iron st.

Standards OutlookThe expanding importance ofrisk management.

Statistics RoundtableFinding just the rightimprovement method.

3.4 per MillionEstimation in a roundabout way.

Career Corner Take control of your brandand your career.

One Good IdeaClowning around can help.

MailQuality Progress/ASQ600 N. Plankinton Ave.Milwaukee, WI 53203Telephone Fax800-248-1946 414-272-1734414-272-8575

EmailFollow protocol of rst initial and full lastname followed by @asq.org (for example,[email protected]).

Article SubmissionsQuality Progress is a peer-reviewed publica-tion with 85% of its feature articles writtenby quality professionals. For informationabout submitting an article, call ValerieEllifson at 800-248-1946 x7373, or [email protected].

Author GuidelinesTo learn more about the manuscript reviewprocess, helpful hints before submitting amanuscript and QPs 2013 editorial planner,click on Author Guidelines at www.qualityprogress.com under Tools andResources."

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Membership and SubscriptionsFor more than 60 years, ASQ has been theworldwide provider of information and learn-ing opportunities related to quality. In addi-tion, ASQ membership offers information,networking, certication and educationalopportunities to help quality profession-als obtain practical solutions to the manyproblems they face each day. Subscriptionsto Quality Progress are one of the manybenets of ASQ membership. To join, call800-248-1946 or see information and anapplication on p. 41.

List RentalsOrders for ASQs member and nonmemberbuyer lists can be purchased by contactingMichael Costantino at the Infogroup/EdithRoman List Management Co., 845-731-2748or 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 ofces: 414-272-8575. Periodicals postage paid at Milwaukee, WI, and at additional mailing ofces. Institutionalsubscriptions are held in the name of a company, corporation, government agency or library. Requests for back issues must be prepaid andare 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 withoutprior notication. 2013 by ASQ. No claim for missing issues will be accepted after three months following the month of publication of theissue 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.

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

- KNOW YOUR OPTIONSHow to address inconsistencies insupplier delivery.

- SOLID SUPPLY CHAINProject provides HIV and AIDSassistance to ailing Kenyans.

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NEXT MONTH

SPECIAL SECTION:ASQ ENTERPRISE ANDSITE MEMBERS p. 50

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UPFRONT

Data DisarrayGet your house in order to reduce risk

DONT YOU JUST hate it when your house gets messyyou look away for just a sec-

ond, and now there are stacks of mai l in three separate places, clothes on the oor of

the closet, and dishes that need to be put away.

An unkempt house may not make you susceptible to dire risk (unless there are ba-

nana peels littering the oor), but messy data and disorganized data management pro-

cesses are a serious threat to organizations livelihoods. And its frighteningly common.

Data management as a crucial ingredient for mitigating risk is at the heart of this

months cover story, Balancing Act, p. 16. Collaboration and control of documents

and information are necessary to ensure silos are broken down and communication is

optimized. The authors provide tips for streamlining data management, one of which is

technology:

Spreadsheets and paper records will never be completely eliminated, but the right

technology system helps signicantly reduce the errors and risks associated with these

components, they wrote. It enables companies to leverage existing IT systems in a way

that invites management, IT, quality and manufacturing to support important risk mitiga-

tion initiatives.

Document control is also an important aspect of reduced risk and increased produc-

tivity. Organizations today are overloaded with data and documentation, and need to take

a step back to get their arms around the magnitude of it, and gure out how to manage it

best. In Avoiding an Avalanche, p. 22, the author provides very specic tips for making

records electronic and storing them in an organized and searchable fashion. Its amazing

the effect careful data management can have.

On a sad note, QP editorial review board member Christine Robinson passed away

last month after a brave battle with pancreatic cancer. For more than two decades,

Christine offered her time and expertise in reviewing countless manuscripts and main-

taining the editorial integrity and reputation readers expect and value from QP. She

will be greatly missed. 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

PRODUCTIONCathy Milquet

ADVERTISING PRODUCTIONBarbara Mitrovic

DIGITAL PRODUCTION SPECIALISTLaura Franceschi

MEDIA SALESNaylor LLCLou BrandowKrys DAntonioNorbert MusialRob ShaferDonnie Tuttle (ASQ TV)

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

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Phone: 866-277-5666ASQ ADMINISTRATIONCEOPaul E. Borawski

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To promote discussion of issues in the eld of quality andensure coverage of all responsible points of view, QualityProgress publishes articles representing conicting and minor-ity views. Opinions expressed are those of the authors and notnecessarily of ASQ or Quality Progress . Use of the ASQ logo inadvertisements does not necessarily constitute endorsement ofthat particular product or service by ASQ.

QUALITY PROGRESS

Q P

May 2013 QP 5

Dont forget to watch the new episode


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Stay ConnectedFind the latest news, quips and targetedcontent from QP and its staff


LOGONThe art of measurementPeter Merrill's March 2013 column onfood safety, Seize the Opportunity,(pp. 44-45) deserves huge kudos forarticulating the fundamental dichotomythat our society faces: cheap and quickinitiatives that generate huge return oncapital employed, yet can have irrevers-ible damage and consequences to the

general health of society. Well done,Peter.

Alex T.C. LauWhitby, Ontario

Acting on feedbackIn response to the One Good Idea article,Survey Fatigue (October 2012, p. 87):Joel Pecoraro writes about ways toimprove customer response rates tosurveys and points out several relevantquestions. However, one of the most

important points was not raised: Providefeedback to customers responding tothe surveyindividually or notinform-ing them of the measures taken to intro-duce improvements based on customersurvey responses. This is the only way toensure that they will answer your nextsurvey.

Basilio V. DagninoRio de Janeiro, Brazil

Following up on LSSIn response to The Right Blend, (Feb-ruary 2013, pp. 18-26): Good article onlean Six Sigma (LSS) implementation inan environment other than manufactur-ing. I am curious about the following:1. How long did it take for the project

to go through the dene, measure,analyze, improve and control (DMAIC)process? Would it have been pos-

+ Seen& Heard

QPS MOST popular ARTICLES(All URLs case sensitive)

1. Likert Scales and Data Analy-ses: Analyses of ordinal dataare not always straightforward.(http://bit.ly/likertscales)

2. Risky Business: Don't letrisk stop you from innovating.(http://bit.ly/riskbusiness)

3. Crunching the Numbers: Alook at how the 2012 SalarySurvey data were compiled.(http://bit.ly/crunchnumbers)

4. Corrective vs. Preventive Action: Don't be confusedabout the difference betweencorrective and preventiveaction. (http://bit.ly/correctvsprevent)

Executive Editor & AssociatePublisher Seiche Sanders:@ASQ_Seiche

Associate Editor Mark Edmund:@ASQ_Mark

Assistant Editor Amanda Hankel:@ASQ_Amanda

Contributing Editor Megan Schmidt:@ASQ_Megan

[email protected]

www.facebook.com/groups/43461176682

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

sible to just use value stream mapsand spaghetti diagrams to achieve thesame results in a shorter amount oftime?

2. After project completion in 2011, haveresults been sustained since the BlackBelt left the project?

3. What happened to the one full-timeemployee (FTE) that was reduced as

a result of a successful LSS project?How did you ensure the accuracyof the time study if the techniciansperceived the purpose of the projectwas to reduce the number of FTEs?

James GaoEdmonton, Alberta

Authors response:1. It took six months to go through

DMAIC. Regarding the second part ofthe question, many other tools, such

as time and motion studies, valueanalysis, Pareto and load leveling, wereused because they were necessaryto assess all processes and apply ap-propriate solutions.

2. Since project completion, results havebeen sustained with great success.This is accomplished through quarterlyscored audits during which any newopportunities for improvement areidentied and current status is evalu-ated.

3. The FTE was laid off. Regarding thesecond part of the question, we didnot mislead anyone, but we also didnot present the project as a headcount reduction project. Our projectscope was bigger than that, as youcan see from the article.

Vera Vanicek Aventura, FL


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May 2013 QP 7

Q PQUALITY PROGRESS

PAST CHAIRJames J. Rooney, ABS Consulting, Global

Government Division

CHAIRJohn C. Timmerman, Gallup Inc.

CHAIR-ELECTStephen K. Hacker, Transformation Systems

International

TREASURERChava Scher, RAFAELAdvanced Defense Systems

(retired)

PARLIAMENTARIANKarla Riesinger, ASQ

DIRECTORSHeather L. Crawford, Apollo EndosurgeryRaymond R. Crawford, Parsons Brinckerhoff Ha 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. MayoElas 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 CommitteeBrady Boggs, Randy Brull, Jane Campanizzi, LarryHaugh, Jim Jaquess, Gary MacLean,R. Dan Reid, Richard Stump

Technical reviewersAndy Barnett, David Bonyuet, David Burger, BernieCarpenter, L.N. Prabhu Chandrasekaran, Ken Cogan,Linda Cubalchini-Travis, Ahmad Elshennawy, MarkGavoor, Kunita Gear, Daniel Gold, T. Gourishankar,

Roberto Guzman, Ellen Hardy, Lynne Hare, RayKlotz, Tom Kubiak, William LaFollette, Pradip Mehta,Larry Picciano, Gene Placzkowski, Tony Polito, PeterPylipow, John Richards, James Rooney, Brian Scullin,Amitava Sengupta, A.V. Srinivas, Joe Tunner, ManuVora, Keith Wagoner, Jack Westfall, Doron Zilbershtein

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

How does telecommuting affect business? It depends on the organization. 65.2% It s a valuable employee benet with few drawbacks. 21.7% It s hurtful in terms of productivity and innovation. 13%

Visit www.qualityprogress.com for the latest question:

What poses the greatest risk to todays organizations? Technology. Data management. Market uncertainty.

Q P

Quality News TODAY Recent headlines from ASQs global news service(All URLs case sensitive)

Yoga Move Reveals Sheer Extent of Lululemons MistakeLululemon Athletica Inc. recalled 17% of its womens pants after they were found to be

too sheer when the fabric is stretched in multiple directions, as it is during a routinedownward dog yoga move. (http://bit.ly/yogamove)

Mitsubishis Melting Lithium-ion BatteryMitsubishi Motors Corp. said that a defect was found in a lithium-ion battery pack usedin a plug-in hybrid vehicle, where the battery was partly melted due to heat it produced.(http://bit.ly/meltingbattery)

More on collaboration Read two online sidebars that accompany the feature article, Balancing Act, (pp. 16-

21) and view an additional gure. Also, in this months Author Audio, listen in as authorsEda Ross Montgomery and Justin Neway talk more about how collaboration amongquality and manufacturing teams, along with the use of technology, is key to managingquality data and reducing risk.

Get smart with your emotions View two additional tables that round out Scott Thors article, Mood Righting (pp. 34-

40), about using emotional intelligence to increase work engagement.

www.qualityprogress.com

ONLINEEXTRAS @

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.


10/68


Leveraging leanQ: I am looking for case studies on suc-

cessful lean programs that give details onhow to undertake a lean program at an IT

products and services company, and how

organizations faced and overcame typical

challenges. For example, how do you mea-

sure, in dollars or cost of sales, a bad seniormanagement decision?

Santosh Mishra

New Westminster, British Columbia

A: The best example I can provide in whichan IT services company is leveraging lean

Six Sigma (LSS) process improvement prin-

ciples is at my own organization, Cbeyond

Communications. We are a $500 million ITand communications service organization

providing voice, data and applications for

small and mid-size businesses. We are fairly

young (12 years old), fast-moving, have

a highly entrepreneurial culture and arecustomer-centric.

Our LSS journey started in 2010 with our

key thought leaders from customer experi-

ence, operations, IT and process excellence

getting in a room and asking some difcultquestions:

What is standing in our way of enhancing

the customer experience?

Can we do this while driving scale into

the business? Where do we put our best resources to

drive the most impact for our customers?

We laid out a value stream map of the

business and identied some high-prole

pain points the organization could rallyaround. Out of those discussions, some

high-prole initiatives emerged that were

closely aligned with our strategic goals,

objectives and key metrics:

Becoming proactive in service man-agement to monitor and troubleshoot

circuits.

Redesigning the interactive voice recog-

nition platform to make it more custom-er-friendly and reduce transfer calls.

Introducing computer telephony integra-

tion in the call center to provide immedi-

ate screen pops for agents to identify

and validate the caller, and save 30seconds in the process on 750,000 calls.

In essence, we were pulling for the

creation of meaningful initiativesnot

pushing projects through the organization.

We set up teams,created business

cases with key

metrics (nancial, operational and customer

satisfaction), were deliberate about identify-

ing root cause issues, and gured out thesmartest way to solve them with our front

line.

We conducted pilots and carefully mea-

sured the results before full deployment.

The best control plan we devised was toget the front line engaged in the process up

front. After they bought into it, they would

enforce itminimizing the need for formal

documentation and audits.

Cbeyond employees took notice. We weregenerating excitement. The projects demon-

strated that achieving scale and customer

satisfaction were not mutually exclusive.

Following a process improvement methodmade sense and could be successful. We

didnt even call it LSS. The method was

becoming part of the culture. Employees rst

started speaking it; then they started practic-

ing ittaking deliberate action.The larger initiatives started a wave of

smaller initiatives. We quit talking about is-

sues in terms of: What is the trouble ticket

rate? or Why isnt IT automating this for

EXPERTANSWE

Project portfolio process / FIGURE 1Stage one Stage two Stage three Stage four

Business alignmentframework

Talk to customers

Identify key metricsand pain points

Strategicquestions

Projectprioritizationscorecard

Project chartertemplate

Dene problem

State the goal

Dene the scope

Strategic(early in the cycle)

Tactical(later in the cycle)

Goals Strategy High potentialareas

Projects

EBITDA = earnings before interest, taxes, depreciation and amortization

Business alignmentframework / FIGURE 2

Source: Peter Sherman, Pick Your Spots, Quality Progress , September 2012, pp. 36-42. Source: Peter Sherman, Pick Your Spots, Quality Progress , September 2012, pp. 36-42.


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May 2013 QP 9

us? Now, we were asking: Whats the prob-

lem? Are we in control? How capable is the

process? That was the tipping point.

Overcoming challenges In 2011, we got serious about deploying the

program. We put together the infrastructure

using the LSS framework: We formalized ourChampion, developed a portfolio process

(Figure 1) that uses a business alignment

framework (Figure 2) to identify the right

projects, and a portfolio tracking system to

measure results.We customized the training around

Cbeyonds business, tailored tools that

would t our needs, and provided ongo-

ing coaching and mentoring. Because ourprocess excellence department is very lean

(only two Six Sigma Black Belts), we had

to scale ourselves. We do this by formally

screening candidates who want to enroll

in Cbeyonds lean Six Sigma Green Beltcertication program. One key criterion is to

submit a project charter signed off on by the

candidates project sponsor. Projects must

be completed within one year of training.

This process ensures the right candidatesand projects are pulled into the program.

Employees are seeing things through a

new set of eyes, asking different questions,

learning to challenge conventional wisdomthrough data and seizing opportunities.

One of the most difcult challenges is get-

ting employees to adopt a business mindset.

Lets face it, a pile of numbers is just thata

pile. Without contextthe surroundinginformationand analysis, they mean noth-

ing. Putting things in context means asking

questions such as: Whats the problem were

trying to solve? Whats the impact? How long

has this been occurring? Where is it happen-inginternally or externally with our custom-

ers? What is the cost of doing nothing?

Making the case for change (the business

case) is one of the most difcult things for

people to get comfortable with. To helpemployees, I conduct mini project charting

workshops. We cover the elements of pre-

paring a basic business case: identifying key

assumptions and drivers, quantifying costs

of poor quality, and projecting savings orrevenue based on improvements. We learn

how to prepare some basic metrics, such as

return on investment, payback period and

break-even analysis.

The other program we started is adecision-making boot camp to help front-

line managers and directors make better

decisions. We educate participants on the

three basic decision-making styles; problem-solving skills; decision-making tools (risk

vs. uncertainty, calculating risk levels and

linking cause and effect) and conduct team

exercises based on actual Cbeyond issues.

The other main challenge we face ismaintaining our levels of energy, focus and

commitment, particularly in the midst of

signicant change. Cbeyond is going through

a major transformation with its products and

services. Employees want to know wherewere going as an organization. They need

to feel theres a real commitment to the

destination and that the aspiration isnt just

the avor of the month.Perhaps most importantly, they need

leaders to help them connect the dots so

they know how their work supports the goal.

Weve found that employees will bring more

energy, focus and commitment to leaderswho can tell a compelling story about our

challenging journey from where we are to

where we want to be. There are lots of shiny

objectsnew directives, different policies

and technology. We cant afford to chasethese shiny objects because well waste

time and resources.

Its a processThe portfolio process and business align-

ment frameworks help us tremendouslyto focus. We combine these frameworks

with a formal process of documenting our

yearly commitments with measurable goals

and timeframes. Managers review these

commitments with their employees twicea year.

At the beginning of the year, department

heads facilitate workout sessions with em-

ployee groups. One activity is called start-

stop-continue. We ask ourselves: Whatshould weas an organizationbe starting,

stopping and continuing? There are always

new ideas. Identifying the things we should

stop doing is the most challenging part.Throughout the year, senior leaders

routinely conduct walkaboutsinformal

meetings with small groups of employees.

They ask: What are the top three things

youre working on? Recognizing the needto keep momentum, our department heads

are starting to conduct weekly team reviews

with their teams, asking questions such as:

What progress did we make this week?

What supported us and our work thisweek?

What setbacks did we have this week?

How can we learn from them?

Did we affect our partners or customerspositively this week? How will we do so

next week?

Were not perfect by any means. It takes

a lot of energy, focus and commitment.

Were in the third inning of a nine-inninggame. Like Brad Pitt said in the movie

Moneyball: Its a process; its a process;

its a process.

Peter J. Sherman

Director of process excellenceCbeyond Communications

Atlanta

RS


12/68

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Contains 2800 de nitions.Helpful for Reliability andQuality Engineers.

ISO

by Bensley & Wortman

Presents a thorough treatmentof the ISO implementation anddocumentation process.

There are generic manuals onthe CD.

by Edenborough

Details the selection,organization, and writingof quality documents.

The disk containsprocedures and workinstructions.

QSH

by Greg Wies & Bert Scali

A convenient book for training internalauditors to the ISO 9001 expectations.

An instructor CD is available.

6th Edition

by Juran & De Feo

The essential quality referencefor most ASQ exams

The Spanish version of theCSSGB Primer.

2nd Edition

by Forrest W. Breyfogle, III

A great CSSBB reference

6th Edition

by Gary K. Grif th

Great for CQT and CQI exams.

Reliability & Maintenance Analyst CD

Measurement Analyst CD

by Bryan Dodson

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

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

Site and global license available!!!Used by Chrysler, ITT, FedEx, Ford,TRW, GM, HP, U.S. Postal Service


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T

QP www.qualityprogress.com2

RECALLS

Back on TrackYoga pants maker aims to put embarrassing recall behind it

KEEPINGCURREThe high-end athletic wear maker Lululemonthinks it has nipped its yoga pants problemsin the bud, already implementing tighter test-ing protocols and oversight to prevent qualityissues from rearing their ugly heads again.

But many still point to Lululemons mis-steps that forced the recall of its black luonpants and crops as a reminder to never sitstill with testing and quality processes, andalways pay close attention to supply chainmanagement strategy.

Everyone has (these issues), even bigcompanies, said Sam Poser, an analyst atSterne, Agee & Leach brokerage rm. ButI dont think its a supply chain issue per se.Its a sit ting-back-on-your-laurels issue andsaying, Were doing it well enough. Usuallythese issues are symptoms of some sortof complacency. It happens to the best ofcompanies. 1

Lululemon was forced to pull 17% of its yoga pants off store shelves in late Marchbecause the material proved to be too sheer.The embarrassing recall was rst blamedon one of Lululemons suppliers, but thecompany later admitted that quality controlwas lacking and testing protocols wereincomplete for some of the pants fabric inquestion. 2

In a press release last month, Lululemonsaid it had already taken steps prior to theblack luon fabric issue to bolster its internalproduct expertise, including the addition ofsenior-level capabilities in quality, raw ma-terials and production. This new team wasinstrumental in determining the root causeof the luon issue and has initiated three workstreams to address what we believe are thecontributing causes:

Testing and processes: A quality team isassessing all luon products in the productionpipeline according to newly implemented

rigorous testing and quality processes thatincludes revised specications for modulus(stretch), weight and tolerances.

Factory oversight: Employees have beenstationed in factories to monitor and testproducts and will educate internal teamsand manufacturing partners on new testingstandards and methods.

Leadership and structure: The companyis building a stronger internal structure withnew leadership and cross-functional team ca-pability to create a more robust organizationto support its long-term growth strategy. 3

The recall of the pants, which cost $70 to$100 a pair, has taken a toll on many fronts:The company estimated the recall will costas much as $67 million, and shares of thecompany dropped 16% shortly after therecall news broke. Its still uncertain how thebrands value was damaged and whether Lu-lulemon can gain back its customers trust. 4

Attention on supply chainIn todays complex and elaborate retailenvironment, retailers must pay close atten-tion to supply chain management strategy,analysts said. Retailers can sell products inbrick-and-mortar stores, through mobile de-vices and on the Internet. These three pointsof distribution opens a lot of supply chain

risk that wasnt there two or three years ago,said Megan Donadio, a retail strategist withthe consulting rm Kurt Salmon. 5

Good supply chain management comesdown to having a true partnership with keysuppliers, said Donadio. You must activelymanage your vendors and not let them man-age you. Thats the real key to a good supplychain strategy. 6

Fast-growing rms such as Lululemonoften face supply chain issues when productsbecome very popular and create a strongdemand. When that surge occurs, companiesmight not have a large supplier base to en-sure quality products are made and delivered.

And if products arent in the stores, yourisk disappointing what is a very loyal Lulule-mon customer, said Brian Sozzi. 7

When plotting out a supply chain strategy,companies must make sure they haveenough suppliers to handle disruptions andmitigate risks, while also ensuring theyrenot spread too thin across suppliers. 8

REFERENCES1. Marilyn Much, Supply Chain Issues Send Retailers to

the Drawing Board, Investors Business Daily, March28, 2013, http://news.investors.com/business-the-new-america/032813-649686-lululemon-and-others-see-supply-chain-issues.htm.

2. Tamara Rutter, Lululemon Takes Responsibility for Failing ItsFans, The Motley Fool, April 8, 2013, www.fool.com/investing/general/2013/04/05/lululemon-takes-responsibility-for-failing-its-fan.aspx.

3. News Bites U.S. Markets, Lululemon Gives Update on Pro-duction Issues, April 5, 2013, http://asq.org/qualitynews/

qnt/execute/displaySetup?newsID=15724 (case sensitive).4. Ashley Lutz, Lululemons Stringent Return Policy is Hurting

Its Business, The Business Insider , April 4, 2013, www.businessinsider.com/lululemons-stringent-return-policy-2013-4.

5. Murch, Supply Chain Issues Send Retailers to the DrawingBoard, see reference 1.

6. Ibid.7. Marilyn Much, Lululemon Luon Pants Fiasco Latest Supply

Chain Issue, Investors Business Daily, March 19, 2013,http://news.investors.com/business/031913-648541-lululemon-athletica-pants-new-supply-chain-problem.htm?p=full.

8. Murch, Supply Chain Issues Send Retailers to the DrawingBoard, see reference 1.
http://www.qualityprogress.com/http://news.investors.com/business-the-new-america/032813-649686-lululemon-and-others-see-supply-chain-issues.htmhttp://news.investors.com/business-the-new-america/032813-649686-lululemon-and-others-see-supply-chain-issues.htmhttp://news.investors.com/business-the-new-america/032813-649686-lululemon-and-others-see-supply-chain-issues.htmhttp://www.fool.com/investing/general/2013/04/05/lululemon-takes-responsibility-for-failing-its-fan.aspxhttp://www.fool.com/investing/general/2013/04/05/lululemon-takes-responsibility-for-failing-its-fan.aspxhttp://www.fool.com/investing/general/2013/04/05/lululemon-takes-responsibility-for-failing-its-fan.aspxhttp://asq.org/qualitynews/qnt/execute/displaySetup?newsID=15724http://asq.org/qualitynews/qnt/execute/displaySetup?newsID=15724http://www.businessinsider.com/lululemons-stringent-return-policy-2013-4http://www.businessinsider.com/lululemons-stringent-return-policy-2013-4http://www.businessinsider.com/lululemons-stringent-return-policy-2013-4http://news.investors.com/business/031913-648541-lululemon-athletica-pants-new-supply-chain-problem.htm?p=fullhttp://news.investors.com/business/031913-648541-lululemon-athletica-pants-new-supply-chain-problem.htm?p=fullhttp://news.investors.com/business/031913-648541-lululemon-athletica-pants-new-supply-chain-problem.htm?p=fullhttp://news.investors.com/business/031913-648541-lululemon-athletica-pants-new-supply-chain-problem.htm?p=fullhttp://news.investors.com/business/031913-648541-lululemon-athletica-pants-new-supply-chain-problem.htm?p=fullhttp://news.investors.com/business/031913-648541-lululemon-athletica-pants-new-supply-chain-problem.htm?p=fullhttp://www.businessinsider.com/lululemons-stringent-return-policy-2013-4http://www.businessinsider.com/lululemons-stringent-return-policy-2013-4http://www.businessinsider.com/lululemons-stringent-return-policy-2013-4http://asq.org/qualitynews/qnt/execute/displaySetup?newsID=15724http://asq.org/qualitynews/qnt/execute/displaySetup?newsID=15724http://www.fool.com/investing/general/2013/04/05/lululemon-takes-responsibility-for-failing-its-fan.aspxhttp://www.fool.com/investing/general/2013/04/05/lululemon-takes-responsibility-for-failing-its-fan.aspxhttp://www.fool.com/investing/general/2013/04/05/lululemon-takes-responsibility-for-failing-its-fan.aspxhttp://news.investors.com/business-the-new-america/032813-649686-lululemon-and-others-see-supply-chain-issues.htmhttp://news.investors.com/business-the-new-america/032813-649686-lululemon-and-others-see-supply-chain-issues.htmhttp://news.investors.com/business-the-new-america/032813-649686-lululemon-and-others-see-supply-chain-issues.htmhttp://www.qualityprogress.com/


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May 2013 QP 13

NTNAME: Ron Berglund.

RESIDENCE: Canton, MI.

EDUCATION: Masters degree inpublic health from the University of Michigan.

CURRENT JOB: Global quality coach, the Quality Guy,Berglunds independent consulting company.

INTRODUCTION TO QUALITY: Berglund used W. Edwards Demings Out of

Chaos in 1980 to train his hospital staff at Saratoga Community Hospital inDetroit to improve processes and systems.

PREVIOUS QUALITY EXPERIENCE: Quality director at Dexter ResearchInc.; senior quality consultant for Omnex, assisting companies with SixSigma implementation; assisted Volvo and ABB Robotics in China to devel-op their supply chains; adjunct graduate professor teaching graduate-levelquality and healthcare courses for 16 years at the College of ExtendedLearning at Central Michigan University in Lansing.

ASQ ACTIVITIES: An ASQ fellow, Berglund is a member of technicaladvisory group 176, Section 1000s Ask the Expert group, a member of ateam that developed the International Organization for Standardization/International Workshop Agreement 1 for health services organizations,and a member of ASQ committees.

OTHER ACTIVITIES: Fellow of the American College of Healthcare Execu-tives, Folmer Award member of the Healthcare Financial ManagementAssociation, and Canton, MI, precinct 38 delegate to select state candi-dates in general elections.

PUBLICATIONS: Berglund has written several articles that have appearedin ASQ newsletters and publications. Most recently, Berglund updatedthe chapter Conducting Successful Improvement Projects, which hecontributed to Hospital Epidemiology and Infection Control, fourth edition,published by Lippincott Williams & Wilkins in 2011.

RECENT AWARDS: Distinguished Faculty of 2012 by the American Collegeof Healthcare Executives.

PERSONAL: Widower with two grown sons and three grandchildren.

FAVORITE WAYS TO RELAX: Golf, writing book reviews for ASQ, writing,and mentoring new people in quality.

QUALITY QUOTE: Quality is common sense, but the problem is that com-mon sense is not very common.

Q Whos Who inGeorge E.P. Box, considered by many to be oneof the most inuential statisticians of the 20thcentury, died last month at his Madison, WI,home. He was 93.

Box was a pioneer in quality control, timeseries analysis, design of experiments andBayesian inference, a statistical approach toproblem solving.

A native of Gravesend, England, Box earneda bachelors degree in mathematics and sta-

tistics. While pursuing hismasters degree, he beganwork at Imperial ChemicalIndustries and eventuallybecame head of the statis-tical techniques researchsection of the company.He later served as visiting

professor at the University of North Carolinaand was at Princeton University as the director

of its statistical research group.Box encouraged the creation of a journal

devoted to statistics and statistical implica-tions. ASQ and the American Statistical As-sociation responded to his encouragement bycreating Technometrics .

In 1960, Box moved to Madison, wherehe was professor and rst chairman of thestatistics department at the University ofWisconsin (UW). His accomplishments in theeld of statistics earned him ASQs ShewhartMedal in 1968. Box published numerous

articles and papers, and authored or co-authored many books, including Statistics forExperimenters, Time Series Analysis: Fore-casting and Control and Bayesian Inferencein Statistical Analysis.

Box was also professor emeritus at UWsCenter for Quality and Productivity Improve-ment. He was an honorary member of ASQ anda three-time recipient of ASQs BrumbaughAward.

OBITUARY

BOX, STATISTICALGIANT, PASSES AWAY


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KEEPINGCURRENTASQ NEWSSECTION RENAMED ASQS OzarkSection 1413 has been renamed theNorthwest Arkansas Section 1413 tobetter represent the geographic areait serves.

TEAM EXCELLENCE FORMS Intentto submit forms for next yearsInternational Team Excellence Awardare due July 1. For more informationon the competition, visit http://wcqi.asq.org/team-competition/timeline.html.

ASQ QUALITY INSTITUTE ASQ isnow offering a series of introduc-tory quality courses July 15-17 at itsheadquarters location in Milwaukee.The ASQ Quality Institute will featuretraining not normally available inclassroom settings. Courses includequality basics, integrated quality man-agement, auditing for improvement,failure mode and effects analysis, andcorrective and preventive action. Visitwww.asq.org/promotional/milwau-kee for more details on the courses,instructors and special registrationoffers.

LAB ACCREDITATION Environmen-tal laboratories can now becomeaccredited to TNI Volume 1 andadditional standards through a singleaccreditation process offered byANSI-ASQ National AccreditationBoard/ACLASS. Environmentallaboratories can be accredited con-currently by ACLASS to the NELACInstitute (TNI) Volume 1: Manage-ment and Technical Requirements forLaboratories Performing Environmen-tal Analysis and to ISO/IEC 17025, theinternational standard for laboratoryaccreditation. For more informationabout the accreditation, visit www.aclasscorp.com.

A majority of midsized manufacturers expect their revenues to increase this year, and 43%said they expect to hire more workers in 2013, according to a survey released recently.

In its annual survey, Prime Advantage, a buying consortium for midsized manufacturers,said most small and midsized manufacturers expect to beat strong revenues of 2012, with68% of respondents anticipating an increase in sales in 2013.

The manufacturers top concern this year is the cost of raw materials. More than 90%of respondents included raw materials in their top three cost-pressure concerns. Health-care costs moved back into second place among top cost-pressure concerns, with 57% ofrespondents including it in the top three.

We are encouraged to see that our members expect to see growth in 2013, after a verystrong 2012 for most, Louise OSullivan, founder, president and CEO of Prime Advantagesaid in a prepared statement. As they focus on protability and margins, we look forwardto partnering with both members and endorsed suppliers to fuel the bottom line, reectingtotal cost of ownership, along with the top line, greater sales and market share.

MANUFACTURING

SURVEY: MIDSIZED MANUFACTURERSEXPECT GROWTH IN REVENUES IN 2013

Quality isnt usually governed and managed

by an organizations centralized quality group,

and measureable quality goals arent always

included in an organizations strategy andgoals for management and support services.

Those are just a few results from ASQs

Global State of Quality Research, scheduled

to be released during ASQs World Confer-

ence on Quality and Improvement (WCQI)May 6-8 in Indianapolis. Some earlier results

from the report include:

30% of respondents indicated quality

is governed and managed by a centralized

quality group.

34% of respondents said they strongly

agree there are measureable quality goals

in their strategies and goals for manage-ment and support services.

14% of respondents strongly agreed they

use quality metrics in variable perfor-

mance compensation.

ASQ partnered with the American Produc-tivity and Quality Center to conduct and man-

age the research and report. A special session

at WCQI to discuss and analyze the research

has been scheduled at 4 p.m. May 7.

ASQ GLOBAL STATE OF QUALITY RESEARCH

QUALITY NOT ALWAYS CENTRALIZED

Every month, QP highlights an open-access article from one ofASQs seven other journals. This month, make sure you read Valueof ISO 90003 Customer Requirement Guidelines to Improve IT Proj-ect Success, which appeared in Decembers edition of SoftwareQuality Professional (SQP).

The article, written by Kaali Dass, is based on a quantitativestudy conducted by nine Project Management Institute chaptersaround the world to measure perceived value of IT project success.

To access the article, click on the Current Issue link on SQPs website: http://asq.org/pub/sqp. From there, you also can nd a link to information about subscrib-ing to the quarterly publication.

ASQ JOURNAL SPOTLIGHT VO LU ME FI FT EE N IS SU E TWO MA RC H 20 13

Software Quality Costs Edited by Taz Daughtrey

Mobile Metrics: Measuring the Accessibilityof Web Contents on Mobile Handsets

Kalpana Johari and Arvinder Kaur

A Scrum Adoption Survey Mark Paulk

Data-driven Estimation, ManagementLead to High Quality

Kate Armel

Software QualityProfessional

www.asq.org
http://www.qualityprogress.com/http://wcqi.asq.org/team-competition/timeline.htmlhttp://wcqi.asq.org/team-competition/timeline.htmlhttp://wcqi.asq.org/team-competition/timeline.htmlhttp://www.asq.org/promotional/milwaukeehttp://www.asq.org/promotional/milwaukeehttp://www.aclasscorp.com/http://www.aclasscorp.com/http://asq.org/pub/sqphttp://asq.org/pub/sqphttp://www.asq.org/http://asq.org/pub/sqphttp://asq.org/pub/sqphttp://www.aclasscorp.com/http://www.aclasscorp.com/http://www.asq.org/promotional/milwaukeehttp://www.asq.org/promotional/milwaukeehttp://wcqi.asq.org/team-competition/timeline.htmlhttp://wcqi.asq.org/team-competition/timeline.htmlhttp://wcqi.asq.org/team-competition/timeline.htmlhttp://www.asq.org/http://www.qualityprogress.com/


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May 2013 QP 15

Mr. Pareto Head BY MIKE CROSSEN

CORRECTIONIn the March 2013 Quality in the FirstPerson column, Show and Tell(pp. 48-49), author Marcia M. Weedenwas misidentied as the chair of theASQs Olde Colony Section. She is thesections voice of the customer chair.QP regrets the error.

Harry S. Hertz, director of the Baldrige Performance Excellence Program since 1992, hasannounced his retirement and will leave the post on June 3.

Deciding to retire in the programs 25th year, Hertz said he thought that was sort ofa good transition point for me and the program. The program has had two leaders in its25 years. It seemed like a good time for me to do something new and for the program tohave some fresh thoughts and leadership.

Hertz said he considered the programs expansion from strictly covering manufactur-

ing and service sectors to including education, healthcare, nonprots and governmentarenas as one of the programs biggest accomplishments while he was at the helm.

The program is no longer viewed as simply an award and has become one of the stan-dards of excellence organizations around the world strive to achieve. The Baldrige criteriaare being practiced in nearly 90 countries, Hertz said.

Weve changed from strictly an award program to a national educational program, Hertzsaid. Its really about education and learning and helping to improve performance broadly.

One of the programs biggest obstacles during Hertzs tenure happened when thefederal government decided it would no longer contribute funds to the programs budget.That meant there was a $9.6 million hole in the programs budget in 2012. But the pro-gram and its partnersincluding the Baldrige Foundation, the Alliance for PerformanceExcellence and ASQ, which administers the programregrouped and developed a differ-

ent business model and plan to maintain operations and continue the program.I think were through the transition now, Hertz said. It was tough.Hertz said he isnt sure what the future holds for him. He has three growing grand-

children who will keep him busy, but he doesnt want to lose touch with the Baldrigeprogram, which he predicts will continue to develop and grow.

Certainly, I want to stay involved in Baldrige somehow, Hertz said. I think it has a lotto offer. I want to continue in some capacityworking with the program and the wonderfulpeople on staff, as well as in the community that has engaged in Baldrige through the years.Ive always been very interested in education, and so Id like to do some teaching, as well.

The Baldrige Program is in the process of seeking a successor. The job has been postedon the www.usajobs.gov fe deral hiring website.

BALDRIGE PROGRAM

LONG-TIME DIRECTOR HERTZ TO RETIRE WORDTOTHEWISETo educate newcomers and refreshpractitioners and professionals, QP oc-casionally features a quality term anddenition:

Right sizeMatching tooling and equipment to

the job and space requirements of lean

production, right sizing is a process that

challenges the complexity of equipment

by examining how equipment ts into

an overall vision for workow througha factory. When possible, right sizing

favors smaller, dedicated machines

rather than large, multipurpose batch

processing ones.

SOURCE:Quality Glossary, Quality Progress , June 2007, p. 55.
http://www.usajobs.gov/http://www.usajobs.gov/


18/68

Balancing ActCollaborationreduces riskin quality datamanagement

by Eda Ross Montgomeryand Justin Neway


19/68

May 2013 QP 17

DATA MANAGEMENT

QUALITY HAS LONG been an initiative, a goal andespe-cially in regulated industriesa requirement for staying in business.

Todays quality professionals are pushing the envelope to take quality

to new levels and make it a way of life for their organizations.

Risk reduction is a driver for quality improvements across corpo-

rate and global boundaries. Standards, such as ISO 9001, have been

widely adopted to minimize risks to consumers. The ISO 9000 seriesof standards have been interpreted to t specic requirements in

various industriesfrom automotive and aerospace manufacturers to

telecommunication and software providers.

These tools are in the early stages of being adopted in the pharma-

ceutical industry as part of the implementation of quality by design

(QbD). In parallel with implementing risk-reducing quality improve-

ments, it is important to also undertake a technical evaluation pro-

gram of product and process improvements to ensure they remain in

place and new risks do not unexpectedly arise.

With common methods and standards in

place, manufacturing organizations also share

a daunting challenge: an increased volume of

electronic and paper-based data collected during

process development and manufacturing. Over-

whelming amounts of data stored in disparate

systems result in the inability to easily access

pertinent data for quality investigations. Quality

teams need easy ways to get accurate views of

product quality, and better manage the time and

resources required to produce standard quality

reports.

In 50 WordsOr Less International standards

organizations recom-mend that life sciencesmanufacturers imple-ment quality by design,making data manage-ment central to an orga-nizations quality strategy.

The collaboration of qual-ity and manufacturingteams to understand andanalyze data to improveprocesses, along withthe use of technology,can help an organizationreduce risk.


20/68


Global pharmaceutical manufacturers sometimes re-

fer to data silos, such as corrective and preventive action

(CAPA) systems, laboratory information management

systems (LIMS), enterprise resource planning, manu-

facturing execution systems, data historians and paper

records. When quality and manufacturing teams investi-

gate a problem using data from multiple siloed systems,

the result is often spreadsheet madness, which leaves in-

dividuals sifting through piles of out-of-context data that

may not even pinpoint the problem.

An added challenge is the lack of collaboration among

most manufacturing and quality teams when it comes to

data management. The online sidebar, Signs of Trouble,

which can be found on this articles webpage at www.

qualityprogress.com, describes four additional indica-

tors that suggest an organizations quality data manage-

ment system needs improving.

Establishing shared goals and a mutual understanding

of the problem can help overcome the practical difcul-

ties of accessing process development and manufactur-

ing data from separate databases and paper records.

When collaboration occurs, signicant paybacks result

from connecting to data in real time for trending analysis.

Life science driversThe life sciences industry serves as an interesting example

because it is relatively behind the curve when it comes to

reducing risk through the management of quality data. Ac-

cording to Pharmaceutical Technologys Equipment and

Processing Report : The industrys approach to risk is more

sophisticated now, but still

has room for improvement

Drug companies some-

times lack certain capabili-

ties that could help enhance

product and process knowl-

edge. 1 Other industries,

such as food and beverage,

and specialty chemicals, are

further along and operate

with smaller prot margins.

Imagine a continuum of

manufactured goods (Fig-

ure 1). One end includes

products that are still sale-

able when variance occurs.

These items can be repur-

posed for an identied mar-

ket when quality lies outside an initial acceptance range

(for example, textiles sold to discount retailers). The

other end holds process manufacturing-based products

that, for safety and legal reasons, cannot be sold when

variance exists.

Until recently, larger margins on products that made

it to pharmacy shelves compensated for large numbers

of lost batches. But recent market forces have created

pressure for reduced pricing, driving the need for life sci-

ences manufacturers to invest in measures to reduce pro-

cess variability, increase yield, and improve quality and

robustness.

Economic factors, such as fewer blockbuster drug

pipelines, loss of patents and outsourcing, are also driv-

ing the life sciences industrys need to control variability

to reduce manufacturing risks and supply chain costs.

Regulators are helping with recommendations, such as

QbD, that present an opportunity to improve manufactur-

ing processes based on new real-time process measure-

ments and by taking advantage of previous experiences

with similar processes.

A decade ago, process analytical technology was intro-

duced by the U.S. Food and Drug Administration (FDA)

as a mechanism for improving real-time process control

and, later, for achieving QbD in pharmaceutical and bio-

technology processes. Since then, the volume of electron-

ic and paper-based data collected during process devel-

opment and manufacturing has increased dramatically.

With risk reduction and improved product quality in

mind, these efforts have helped make QbD a way of life

for the life sciences industry. As a result, more of the

processes that make life sciences products have quality

designed into them rather than just involving testing the

quality of the product at the end of the production line.

Regulators encourage collaboration among manufac-

turing and quality teams with guidelines that integrate the

two areas. In its 2008 Q10 document, the International

Conference on Harmonization of Technical Requirements

for Registration of Pharmaceuticals for Human Use (ICH)

said, ICH Q10 demonstrates industry and regulatory au-

thorities support of an effective pharmaceutical quality

system to enhance the quality and availability of medi-

cines around the world in the interest of public health.

Implementation of ICH Q10 throughout the product

life cycle should facilitate innovation and continual im-

provement and strengthen the link between pharmaceuti-

cal development and manufacturing activities. 2

ICH Q10 outlines a quality management system

Continuum ofmanufacturedgoods / FIGURE 1

Ability to repurpose productLow High

A d v e r s e c o n s e q u e n c e s o f l o w q u a l i t y

Low

High

Textiles todiscountretailers

Pharma-ceuticals


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May 2013 QP 19

modelthe Pharmaceutical Quality Systemand states

that implementation of the Q10 model should result in

achievement of three main objectives which comple-

ment or enhance regional good manufacturing practice

requirements: 3

1. Achieve product realization: supports operation of

processes that meet appropriate quality attributes.

2. Establish and maintain a state of control: en-

ables risk-based monitoring and control systems for

process performance and product quality, providing

assurance of continued suitability (for example, the

ability for the process to continue producing the in-

tended outcomes) and capability of processes.

3. Facilitate continual improvement: strengthens the

knowledge or data link between development, manu-

facturing and quality.

ICH Q10 also facilitates a life-cycle approach to qual-

ity management and risk reduction. It was decided to go

to ICH Q10 to bring the ICH vision to fruition over the

product life cycle, explained Joseph Famulare, former

deputy director of the Ofce of Compliance in the FDAs

Center for Drug Evaluation and Research. The result is

that rms that employ QbD and use risk-management

principles (ICH Q8 and ICH Q9) can use a robust quality

system to manage change and continual improvement,

and this would lessen the need for post-approval (regu-

latory) lings, putting quality more in the hands of the

manufacturer, he said. 4

Intersection of quality and manufacturingWhen manufacturing organizations implement quality im-

provement initiatives, quality and manufacturing teams

can interact in new ways to achieve shared goals. Today,

most quality systems are designed to serve the needs of

the quality team, such as verifying assessments and pub-

lishing results. By design, LIMS alone are not focused on

making a manufacturing process more successful.

Collaboration in the name of quality data management

requires a paradigm shift that organizes data around the

manufacturing process and resulting product control

strategy, rather than around samples, control of analytical

workows, control of standards and analyststhe cur-

rent organizing principles on which LIMS are based.

For example, results may be posted and veried

about the selenium content of a particular sample, but

why would someone want to see the data for an individ-

ual sample? Ultimately, the goal is to better control the

process that produces the samples, so there needs to be

a combined or unied process-centric view of product

development, quality and manufacturing across the IT

systems. This shift in thinking must be made attractive to

team members who may be resistant to it, and champi-

oned by those who value a shared purpose between qual-

ity and manufacturing teams.

As another example, annual product reviews (APR)

typically are qualitys responsibility, and they are organized

around individual drugs. In a more collaborative environ-

ment, the APR process itself can be the organizing prin-

ciple for data. Information about specication failures and

process deviations is shared among the combined process

development, quality and manufacturing teams.

A quality team might see trend charts and ask how the

problem will be solved. The next step before taking correc-

tive action is to dig through the data from disparate sourc-

es and reorganize it using error-prone manual methods.

An added complexity is that different quality teams

often have different data languages that result from their

unique needs and make it impractical to organize the data

in one way that will satisfy all their needs. An example of

the different data languages used by quality teams with

varying priorities is when one team uses deviations as a

driver for batch release and another team uses control

charts as a driver for change control.

The increased use of contract manufacturing organiza-

tions (CMO) on a global scale (up to 40% of drugs Ameri-

cans take are currently manufactured outside the United

States) increases the challenge of achieving this unied,

process-centric view across all aspects of the organiza-

tion. 5 But in these situations, it is even more critical that

all aspects of sponsor and contract or supplier organiza-

tions are aligned on the strategy and tactics for ensuring

ongoing product quality.

Quality cant execute on its own without the ability

to collaborate in a world where teams share a common

language (data and facts in context) organized around a

process. For example, the temperature might be X, but in-

vestigators also might need to know characteristics of the

previous process step or input material before they will

be able to recommend appropriate action.

Critical success factors include providing end users

with on-demand access to data in a collaborative analyt-

ics, trending and reporting environment in which the mul-

tidisciplinary team can work together productively.

The most important requirements for this system are:

A simple user-centric interface for direct, on-demand

access to all the data from disparate sources.

DATA MANAGEMENT


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A practical way to capture paper-based data and make

it easily available in electronic form.

The ability to work with continuous and discrete data

together, sharing data, analysis results and reports

across disciplines, scales of operation and geographi-

cally dispersed sites.

Simplifying the preparation and distribution of analy-

sis results.

Automating the generation of periodic reviews and

reports of batches and campaigns.

The ICH Q10 process performance and product quality

monitoring system section says: Pharmaceutical compa-

nies should plan and execute a system for the monitor-

ing of process performance and product quality to ensure

a state of control is maintained. An effective monitoring

system provides assurance of the continued capability of

processes and controls to produce a product of desired

quality and to identify areas for continual improvement. 6

The right tools, such as data aggregation, analysis, con-

textualization and reporting, will work with existing qual-

ity systems by adding a layer on top (Figure 2) to span

quality and manufacturing systems and provide access to

the necessary data.

In October 2010, the International Society for Pharma-

ceutical Engineering (ISPE) released Overview of Product

Design, Development, and Realization: A Science- and Risk-

Based Approach to Implementation. According to Phar-

maQbD.com, ISPEs

product quality life

cycle implementation

initiative has been

one of the leading

efforts to translate

ICH guidance on sci-

ence and risk-based

manufacturing into

more practical lan-

guage and to outline

how Q8, Q9 and Q10

might be applied by

industry. 7

Meanwhile, the

American Society

for Testing and Ma-

terials is developing

standards for in-

dustry that provide

practical approach-

es to implementing ICH Q8-10 8 and the FDAs process

validation guidance. 9

Technology tools (such as software), used for data ana-

lytics should work with quality assurance data systems to

enable and support ICH Q10 product life cycle manage-

ment goals in the following areas: 10

Global. Provide a Part 11 compliant (a Code of Feder-

al Regulations requirement for integrity and security

of electronic data), audit-trailed capability to capture

paper-based data in electronic form in a network-

accessible database available to all users; enable

centralized experts to prepare and distribute outputs

for widespread use and updating by globalized teams

of diverse, nonstatistical users; provide a collabora-

tive data access and analytics platform that spans

geographic and organizational boundaries (between

sponsors and CMOs) so teams with shared concerns

can achieve their joint goals.

Process performance and quality monitoring.

Provide observational users an updated portal or

dashboard to display status data anywhere, anytime.

Simplify and reduce the cost of periodic quality re-

view, APR and production report preparation and

distribution; provide views of test method processes

to study and reduce test method variability; provide a

collaborative platform for comparison of internal and

outsourced operations and quality data.

CAPA. Provide a link between customer-complaint

data and product testing and production data to un-

derstand cause-and-effect relationships; enable a link

between process development and manufacturing

sample testing to make comparisons; enable testing

and implementation of process improvements.

Change management. Provide a platform for imme-

diate access, organization and ow of data for inter-

nal communications.

Management review. Provide management users an

updated portal or dashboard to display status data

anywhere anytime; provide easy access to and organi-

zation of data for timely preparation of management

reports; provide a collaborative platform to enable

staff to implement management actions.

An example of how a global life sciences manufac-

turing company with a quality trend monitoring system

met these criteria while implementing a paradigm shift

for collaborating to achieve multi-year initiative goals

is discussed in the online sidebar, A Life Sciences Case

Study.

Collaboration tools / FIGURE 2LIMS CAPA MES HIST

Quality Manufacturing

Collaboration tools

(Data aggregation, analysis, contextualizationand reporting)

CAPA = corrective and preventive actionHIST = data historiansLIMS = laboratory information management systemsMES = manufacturing execution systems


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May 2013 QP 21

Tips for successBased on rst-hand practical experience, the top ve

tips for change management with quality and manufac-

turing teams include:

Minimize time requirements. No one resists the

concept of quality trend monitoring, but some fear the

perceived effort and time it might take. It is important

to reserve the time needed for initial benchmarking and

conduct ongoing collaborative data analysis.

Centralize. Having a central project group to relieve

the workload and evangelize the approach can drive suc-

cess. It can help if a central group is charged with doing

baseline analysis to minimize the burden placed on other

groups.

Train. Provide basic statistical training across groups to

ensure uniform capabilities. Guidance documents assist

in eliminating subjectivity that might affect results.

Communicate. Teams must meet regularly to review

data so quality, plant and manufacturing operations

groups can communicate consistently. There may be

initial resistance to global visibility of data when pro-

ducing the same product at multiple sites and contract

sites, but the payoff is a more thorough and routine

examination of variation and a consequent reduction

in variability across sites.

Automate. The right technology tools enable routine

monitoring without interruption. Manual data must be

incorporated using automation and technology that

minimizes error. Automating data access, aggregation

and contextualization, which involves organizing re-

lated data into groups or batches in preparation for

analysis is a massive time-saver. While monthly analy-

sis is a minimum requirement to ensure that trends in

high-volume products are identied and controlled,

technology tools allow the option for daily updates

due to reduced cost and effort requirements.

Quality and manufacturing teams can apply these les-

sons for better quality data management. Ultimately, life

sciences companies can use up-front analysis to identify

continuous improvement opportunities by identifying the

products with the least acceptable outcomes (for exam-

ple, high variability in pH values). They can triage the list

to drive goals and priorities for the manufacturing and

quality organizations.

New products, as well as additional manufacturing

sites, can be brought into the quality data trend monitor-

ing program. The same approach can be used to develop

joint goals and implement continuous improvement ac-

tivities between sponsor companies and CMOs.

Quality can truly be a way of life with the right man-

agement structures and technology. A collaborative ap-

proach that meets ICH Q10 guidelines and adds a data

access contextualization layer over existing technology

systems can improve overall quality data management.

Spreadsheets and paper records will never be com-

pletely eliminated, but the right technology system helps

signicantly reduce the errors and risks associated with

these components. It enables companies to leverage ex-

isting IT systems in a way that invites management, IT,

quality and manufacturing to support important risk miti-

gation initiatives. QP

REFERENCES1. Erik Greb, Moving From a Reactive to a Systemic Approach to Manage Risk,

Pharmaceutical Technology Equipment and Processing Report, Dec. 21, 2011,http://pharmtech.ndpharma.com/pharmtech/Online+Only/Moving-from-a-Reactive-to-a-Systemic-Approach-to-/ArticleStandard/Article/detail/752605?contextCategoryId=40939 (case sensitive).

2. International Conference on Harmonization of Technical Requirements forRegistration of Pharmaceuticals for Human Use, ICH Q10, 2008 www.ich.org/leadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q10/Step4/Q10_Guideline.pdf (case sensitive).

3. Ibid.4. Patricia Van Arnum, ICH-Q10: A Recipe for the Product Life Cycle, Pharmaceu-

tical Technology , Sept. 2, 2007, http://pharmtech.ndpharma.com/pharmtech/Special+Report/ICH-Q10-A-Recipe-for-the-Product-Life-Cycle/ArticleStandard/Article/detail/452944 (case sensitive).

5. Margaret A. Hamburg, Import Safety: Status of FDAs Screening Efforts at theBorder, testimony before the U.S. House Subcommittee on Oversight and In-vestigations, April 13, 2011, www.fda.gov/newsevents/testimony/ucm250710.htm.

6. Greb, Moving From a Reactive to a Systemic Approach to Manage Risk, seereference 1.

7. Another QbD Milestone: PQLI Releases Introductory Good Practice Guide,PharmaQbD.com, Oct. 22, 2010, www.pharmaqbd.com/pqli_releases_good_practice_guide.

8. ASTM International, ASTM E2500-07 (2012): Standard Guide for Specication,Design and Verication of Pharmaceutical and Biopharmaceutical Manufactur-ing Systems and Equipment, www.astm.org/Standards/E2500.htm (casesensitive).

9. U.S. Food and Drug Administration, Guidance for Industry: Process Validation:General Principles and Practices, January 2011, www.fda.gov/downloads/drugs/guidancecomplianceregulatoryInformation/guidances/ucm070336.pdf.

10. Greb, Moving From a Reactive to a Systemic Approach to Manage Risk, seereference 1.

DATA MANAGEMENT

JUSTIN NEWAY is vice president and chief sci-ence ofcer of analytical, development, quality

and manufacturing solutions for Accelrys inBoulder, CO. He has a doctorate in biochemistryfrom the University of Illinois in Champaign.

EDA ROSS MONTGOMERY is senior director and

technical steward at Shire in Wayne, PA. Shehas a doctorate in analytical chemistry from theUniversity of North Carolina in Chapel Hill.


24/68

Avoiding an AvalancheIn 50 WordsOr Less Organizations can be

overwhelmed by anavalanche of informa-tion and documenta-tion, which can lead toprocess inefcienciesand lost productivity, aswell as increased riskand liability.

Centralized electronicdocument and datacontrol processeswithin a quality man-agement system helporganizations managecritical and sensitivecontent and make moreinformed decisions.

by Greg Milliken

Proper control of documents anddata within a QMSwill reduce riskand liability


25/68

May 2013 QP 23

DATA MANAGEMENT

ORGANIZATIONS THAT MAKE productswith rigorous quality requirements face numerous challenges

associated with meeting objectivesranging from complying

with standards (such as ISO 9001 and current good manu-

facturing practice, or cGMP) to operating in highly regulated

and frequently audited environments.Organizations of all sizes and across all industries can

easily fall victim to quality issues without effective informa-

tion control as a core component of their quality management

systems (QMS). The result can range from organizational in-

efciencies and poorly allocated resources to negative brand

perception, lost revenue and increased liability.


26/68


Without a centralized and organizationwide ap-

proach to managing information, organizations leave

themselves vulnerable because of the difculty and

complexity of managing critical and sensitive content

and processes that affect quality and compliance. On

the other hand, organizations that adhere to a pragmat-

ic, day-to-day approach to managing quality informa-

tion not only operate at a vastly superior level, but also

reduce risk and liability.

Establishing document and data control processes

within a quality management framework improves

manufacturing and production processes, enhances

collaboration, optimizes the use of existing resources,

and drives organizational efciencies that affect an or-

ganizations bottom-line business objectives.

To better understand how information control is an

integral component of quality management, you must

recognize the challenges associated with manual qual-

ity processes, the types of content typically managed

within a QMS, how data management can improve

compliance-related activities, and how an effective

solution for information control can signicantly im-

prove quality systems and processes.

Challenges of manual quality processesFor many organizations, data and document control

processes are managed separately by different depart-

ments. This proves ineffective as individuals in one

department lack visibility into important information

control procedures implemented within other depart-

ments.

In addition to the challenge of coordinating often

disparate electronic data management methods, the

problem is frequently exacerbated by the use of archa-

ic, manual processes for storing and organizing critical

documentation in physical le folders.

Manual information control procedures are error-

prone, and may inadvertently compromise an or-

ganizations ability to comply with regulations and

standards such as cGMP and ISO 9001. Furthermore,

organizations also can incur high costs because of the

excess time and resources needed to manually manage

documentation required to maintain compliance and

mitigate operational risks.

The manual approach to document and data control

is rife with aws that can negatively impact the integ-

rity of an organizations QMS. If the following ques-

tions are being asked frequently at your organization,

its time to consider incorporating a formal electronic

content control solution into your QMS:

Who is the gatekeeper? A manual quality process

often revolves around one person who manages all

essential quality-related documentation. What hap-

pens if this person stays home sick, takes vacation

or leaves the organization?

Where does all of our documentation reside?

Quality management is information-intensive, and

the number of associated documents can grow ex-

ponentially over time. Many quality-related records

require approval by signature, which traditionally

has meant storing paper-based documents in physi-

cal le cabinets. In a manual paper-based quality

environment, its difcult to nd documents and

verify the existence of back-up les of signed re-

cords. Theres also a signicant investment in stor-

age space to maintain essential documentation.

Did you get that email? Its often difcult to get

up-to-date information about the state of quality

documentation and processes because related in-

formation and communications often are dispersed

among unrelated collections of paper documents,

electronic les and emails. In this environment, its

almost impossible to get a quick answer to a simple

question such as, Have the required people read

the new instructions we approved two weeks ago?

How are quality processes managed? Many or-

ganizations have instituted quality policies featur-

ing specic repetitive tasks such as weekly system

health checks, periodic maintenance, monthly data

recovery tests or regular standard operating proce-

dure (SOP) reviews. Organizations, however, often

nd it challenging to actually ensure these tasks are

completed on time and according to policy guide-

lines because only a limited number of people (of-

ten one) have visibility into how quality processes

are managed.

Have quality issues been resolved? Audits, in-

spections and normal daily operations produce dif-

ferent kinds of issues, nonconformities, audit nd-

ings and protocol deviations. Manual quality issue

management is not only tedious, but its also error-

prone and tends to deteriorate over time. Qual-

ity managers can do little other than send endless

email reminders and make follow-up phone calls

about pending corrective actions.

Today, more manufacturers realize that to mitigate


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May 2013 QP 25

risk associated with production processes and proce-

dures, an effective information management system

must be implemented. Modern content management

solutions deliver high levels of management and con-

trol, empowering organizations to improve productiv-

ity, reduce production costs, ensure compliance and

reduce risk.

Content categories within a QMSManufacturing organizations produce an overwhelm-

ing amount of information. Adequately managing

inspection sheets, audit reports, nonconformance

documents, corrective and preventive actions (CAPA),

customer complaints and inquiries can be a daunting

and resource-draining task.

When integrating a solution for document and data

control as a component of a QMS, one of the rst steps

is to dene the categories of documents that exist (or

will exist) in the course of business. After primary cat-

egories are dened, more specic types of information

within each category also can be dened.

The goal of identifying specic data categories is to

paint a comprehensive picture of how a product was

designed, what decisions were made during the pro-

cess (including why certain alternative designs were

rejected), how a product was tested, and why that test-

ing was reasonable and adequate. Another important

goal is to show how an organization responsibly pro-

cesses and responds to complaints and mishaps.

The following are examples of broad content cat-

egories organizations typically establish within their

QMSs:

1. Product design and development.

2. Manufacturing and quality control.

Documents

Issue ABRIL 2013.pdf