Issue ABRIL 2013.pdf

Quality Progress | May 2013

P

Putting Best Practices to Work

QUALITY PROGRESS

Managing

manage risk

Risk Find firmer footing with a well-balanced data management plan p. 16 Plus: Corral your documents and data p. 22 Team up to improve efficiency p. 28

www.qualityprogress.com | May 2013

Get Emotional: Understand Its Role In the Workplace p. 34

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

FEATURES 16

16

DATA MANAGEMENT

Balancing Act

Better management of quality data can help organizations identify continuous improvement opportunities, reduce risk and improve product quality.

by Eda Ross Montgomery and Justin Neway

22

Avoiding an Avalanche

Lessen liability and reduce risk by getting a better handle on data and documents within your quality management system.

by Greg Milliken

28

PROCESS IMPROVEMENT

What Makes You Tick?

Break up operational logjams within your organization to boost business performance and better serve customers.

by H.F. Ken Machado

34

EMOTIONAL INTELLIGENCE

Mood Righting

High levels of emotional intelligence create a workforce that is more engaged, dedicated and productive, a recent study reveals.

Only @

www.qualityprogress.com

by Scott Thor

• Hearing Aid

Listen to the authors of “Balancing Act” (pp. 16-21) discuss the importance of better quality data management. Also read two exclusive online sidebars that expand on this month’s cover article.

• More From Thor

Two additional tables containing correlation and regression results from the study on emotional intelligence and work engagement, the subject of Scott Thor’s “Mood Righting”(pp. 34-40).

• Read All About It

34

Get the latest Quality News Today headlines.

• Popularity Contest

Check out what QP readers have clicked on most often.

QP

DEPARTMENTS 6

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8

Expert Answers

12

• Sustaining lean Six Sigma project results.

QUALITY PROGRESS

• How an IT firm advanced with lean Six Sigma.

Mail

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

Keeping Current

• Lessons from the Lululemon recall. • Statistics pioneer Box passes away.

Email

15

Mr. Pareto Head

58

QP Toolbox

60

QP Reviews

12

42 45

Up Front

Data disarray.

Innovation Imperative Controlling risk within the innovation process.

Quality in the First Person

The mistake of managing with an iron fist.

46

Author Guidelines

46

Standards Outlook

48

Statistics Roundtable

54

3.4 per Million

57

Career Corner

64

One Good Idea

The expanding importance of risk management. Finding just the right improvement method.

Estimation in a roundabout way. Take control of your brand— and your career. Clowning around can help.

Special section: ASQ enterprise and site members p. 50

NEXT MONTH

- know your options How to address inconsistencies in supplier delivery.

- solid supply chain Project provides HIV and AIDS assistance to ailing Kenyans.

ASQ’s Vision: By making quality a global priority, an organizational imperative and a personal ethic, the American Society for Quality becomes the community for everyone who seeks quality technology, concepts or tools to improve themselves and their world. Quality Progress (ISSN 0033-524X) is published monthly by the American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203. Editorial and advertising offices: 414-272-8575. Periodicals postage paid at Milwaukee, WI, and at additional mailing offices. Institutional subscriptions are held in the name of a company, corporation, government agency or library. Requests for back issues must be prepaid and are based on availability: ASQ members $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.

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

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QUALITY PROGRESS

Data Disarray Get your house in order to reduce risk

Executive Editor and Associate Publisher Seiche Sanders

Associate Editor Mark Edmund

Assistant Editor Don’t you just hate it when your house gets messy—you look away for just a sec-

Amanda Hankel

ond, and now there are stacks of mail in three separate places, clothes on the floor of

manuscript Coordinator

the closet, and dishes that need to be put away. An unkempt house may not make you susceptible to dire risk (unless there are banana peels littering the floor), but “messy” data and disorganized data management processes are a serious threat to organizations’ livelihoods. And it’s frighteningly common. Data management as a crucial ingredient for mitigating risk is at the heart of this month’s 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:

Valerie Ellifson

contributing EDITOR Megan Schmidt

COPY EDITOR Susan E. Daniels

Art Director Mary Uttech

Graphic Designer Sandy Wyss

Production

“Spreadsheets and paper records will never be completely eliminated, but the right technology system helps significantly 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 mitigation initiatives.” Document control is also an important aspect of reduced risk and increased productivity. 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 figure out how to manage it best. In “Avoiding an Avalanche,” p. 22, the author provides very specific tips for making records electronic and storing them in an organized and searchable fashion. It’s 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 maintaining the editorial integrity and reputation readers expect and value from QP. She will be greatly missed. QP

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Seiche Sanders Editor

Don’t forget to watch the new episode

Julie Gabelmann Brian J. LeHouillier Michelle Mason Laurel Nelson-Rowe

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

May 2013 • QP

5

logon +Seen&Heard The art of measurement Peter Merrill's March 2013 column on food safety, “Seize the Opportunity,” (pp. 44-45) deserves huge kudos for articulating the fundamental dichotomy that our society faces: cheap and quick initiatives that generate huge return on capital employed, yet can have irreversible damage and consequences to the general health of society. Well done, Peter. Alex T.C. Lau Whitby, Ontario

Acting on feedback In response to the One Good Idea article, “Survey Fatigue” (October 2012, p. 87): Joel Pecoraro writes about ways to improve customer response rates to surveys and points out several relevant questions. However, one of the most important points was not raised: Provide feedback to customers responding to the survey—individually or not—informing them of the measures taken to introduce improvements based on customer survey responses. This is the only way to ensure that they will answer your next survey. Basilio V. Dagnino Rio de Janeiro, Brazil

Following up on LSS In response to “The Right Blend,” (February 2013, pp. 18-26): Good article on lean Six Sigma (LSS) implementation in an environment other than manufacturing. I am curious about the following: 1. How long did it take for the project to go through the define, measure, analyze, improve and control (DMAIC) process? Would it have been pos-

6

QP • www.qualityprogress.com

sible to just use value stream maps and spaghetti diagrams to achieve the same results in a shorter amount of time? 2. After project completion in 2011, have results been sustained since the Black Belt left the project? 3. What happened to the one full-time employee (FTE) that was reduced as a result of a successful LSS project? How did you ensure the accuracy of the time study if the technicians perceived the purpose of the project was to reduce the number of FTEs? James Gao Edmonton, Alberta Author’s response: 1. It took six months to go through DMAIC. Regarding the second part of the question, many other tools, such as time and motion studies, value analysis, Pareto and load leveling, were used because they were necessary to assess all processes and apply appropriate solutions. 2. Since project completion, results have been sustained with great success. This is accomplished through quarterly scored audits during which any new opportunities for improvement are identified and current status is evaluated. 3. The FTE was laid off. Regarding the second part of the question, we did not mislead anyone, but we also did not present the project as a “head count reduction” project. Our project scope was bigger than that, as you can see from the article. Vera Vanicek Aventura, FL

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

Executive Editor & Associate Publisher Seiche Sanders: @ASQ_Seiche

Associate Editor Mark Edmund: @ASQ_Mark Assistant Editor Amanda Hankel: @ASQ_Amanda Contributing Editor Megan Schmidt: @ASQ_Megan [email protected] www.facebook.com/ groups/43461176682 www.linkedin.com/groups/qualityprogress-magazine-asq-1878386

QP popular

’s Most articles

(All URLs case sensitive)

1. Likert Scales and Data Analyses: Analyses of ordinal data are not always straightforward. (http://bit.ly/likertscales) 2. Risky Business: Don't let risk stop you from innovating. (http://bit.ly/riskbusiness) 3. Crunching the Numbers: A look at how the 2012 Salary Survey data were compiled. (http://bit.ly/crunchnumbers) 4. Corrective vs. Preventive Action: Don't be confused about the difference between corrective and preventive action. (http://bit.ly/ correctvsprevent)

QP

QP

Online Extras@

QUALITY PROGRESS

www.qualityprogress.com PAST CHAIR

• More on collaboration Read two online sidebars that accompany the feature article, “Balancing Act,” (pp. 1621) and view an additional figure. Also, in this month’s Author Audio, listen in as authors Eda Ross Montgomery and Justin Neway talk more about how collaboration among quality and manufacturing teams, along with the use of technology, is key to managing quality data and reducing risk.

• Get smart with your emotions

CHAIR

John C. Timmerman, Gallup Inc.

CHAIR-ELECT

Stephen K. Hacker, Transformation Systems International

TREASURER

View two additional tables that round out Scott Thor’s article, “Mood Righting” (pp. 3440), about using emotional intelligence to increase work engagement.

Chava Scher, RAFAEL—Advanced Defense Systems (retired)

PARLIAMENTARIAN Karla Riesinger, ASQ

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: How does telecommuting affect business? • It depends on the organization. • It‘s a valuable employee benefit with few drawbacks. • It‘s hurtful in terms of productivity and innovation.

James J. Rooney, ABS Consulting, Global Government Division

65.2% 21.7% 13%

Visit www.qualityprogress.com for the latest question: What poses the greatest risk to today’s organizations? • Technology. • Data management. • Market uncertainty.

DIRECTORS

Heather L. Crawford, Apollo Endosurgery Raymond R. Crawford, Parsons Brinckerhoff Ha Dao, Emerson Climate Technologies Inc. Gary N. Gehring, Saskatchewan Ministry of Governmental Relations Kathleen Jennison Goonan, M.D., Goonan Performance Strategies Eric A. Hayler, BMW Manufacturing Co. James M. Loseke, Sargento Foods Inc. Joanne D. Mayo Elías Monre´al, Industrial Tool Die and Engineering Richard A. Perlman, Bayer HealthCare Steven J. Schuelka, Calumet College Daniel E. Sniezek, Lockheed Martin (retired) G. Geoffrey Vining, Virginia Tech Department of Statistics Alejandra Vicenttin, Alejandra Vicenttin Advisors Bharat Wakhlu, Tata Services Ltd., a division of Tata Sons J. Eric Whichard, JE Whichard and Associates

QP EDITORIAL REVIEW BOARD Randy Brull, chair

QualityNewsToday

Administrative Committee

(All URLs case sensitive)

Technical reviewers

Recent headlines from ASQ’s global news service Yoga Move Reveals Sheer Extent of Lululemon’s Mistake Lululemon Athletica Inc. recalled 17% of its women’s pants after they were found to be too sheer when the fabric is stretched in multiple directions, as it is during a routine downward dog yoga move. (http://bit.ly/yogamove) Mitsubishi’s Melting Lithium-ion Battery Mitsubishi Motors Corp. said that a defect was found in a lithium-ion battery pack used in a plug-in hybrid vehicle, where the battery was partly melted due to heat it produced. (http://bit.ly/meltingbattery)

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

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.

May 2013 • QP

7

expertanswe Leveraging lean

the customer experience?

Q: I am looking for case studies on successful lean programs that give details on how to undertake a lean program at an IT

metrics (financial, operational and customer

• Can we do this while driving scale into the business?

satisfaction), were deliberate about identifying root cause issues, and figured out the

• Where do we put our best resources to

products and services company, and how

drive the most impact for our customers?

organizations faced and overcame typical

We laid out a value stream map of the

smartest way to solve them with our front line. We conducted pilots and carefully mea-

challenges. For example, how do you mea-

business and identified some high-profile

sured the results before full deployment.

sure, in dollars or cost of sales, a bad senior

pain points the organization could rally

The best control plan we devised was to

management decision?

around. Out of those discussions, some

get the front line engaged in the process up

high-profile initiatives emerged that were

front. After they bought into it, they would

closely aligned with our strategic goals,

enforce it—minimizing the need for formal

objectives and key metrics:

documentation and audits.

Santosh Mishra New Westminster, British Columbia A: The best example I can provide in which

• Becoming proactive in service man-

Cbeyond employees took notice. We were

an IT services company is leveraging lean

agement to monitor and troubleshoot

generating excitement. The projects demon-

Six Sigma (LSS) process improvement prin-

circuits.

strated that achieving scale and customer

ciples is at my own organization, Cbeyond

• Redesigning the interactive voice recog-

Communications. We are a $500 million IT

nition platform to make it more custom-

Following a process improvement method

and communications service organization

er-friendly and reduce transfer calls.

made sense and could be successful. We

providing voice, data and applications for

• Introducing computer telephony integra-

satisfaction were not mutually exclusive.

didn’t even call it LSS. The method was

small and mid-size businesses. We are fairly

tion in the call center to provide immedi-

becoming part of the culture. Employees first

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

ate screen pops for agents to identify

started speaking it; then they started practic-

a highly entrepreneurial culture and are

and validate the caller, and save 30

ing it—taking deliberate action.

customer-centric.

seconds in the process on 750,000 calls.

Our LSS journey started in 2010 with our

In essence, we were “pulling” for the

The larger initiatives started a wave of smaller initiatives. We quit talking about is-

key thought leaders from customer experi-

creation of meaningful initiatives—not

sues in terms of: “What is the trouble ticket

ence, operations, IT and process excellence

“pushing” projects through the organization.

rate?” or “Why isn’t IT automating this for

getting in a room and asking some difficult

We set up teams,

questions:

created business

• What is standing in our way of enhancing

cases with key

Project portfolio process Stage one Identify initial projects • Business alignment framework

Goals

/ figure 1

Stage two

Stage three

Stage four

Validate projects

Prioritize projects

Charter projects

• Strategic questions

• Talk to customers • Identify key metrics and pain points Strategic (early in the cycle)

• Project prioritization scorecard

Business alignment framework / figure 2

• Project charter template – Define problem

Strategy

High potential areas

High potential

Projects

Project Project Project

High potential

Project Project

– State the goal – Define the scope Tactical (later in the cycle)

“Pulling” for the creation of projects that are aligned with our goals, strategies and metrics. EBITDA = earnings before interest, taxes, depreciation and amortization

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

8

QP • www.qualityprogress.com

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

rs us?” Now, we were asking: “What’s the prob-

Making the case for change (the business

It’s a process

lem? Are we in control? How capable is the

case) is one of the most difficult things for

The portfolio process and business align-

process?” That was the tipping point.

people to get comfortable with. To help

ment frameworks help us tremendously

employees, I conduct mini project charting

to focus. We combine these frameworks

Overcoming challenges

workshops. We cover the elements of pre-

with a formal process of documenting our

In 2011, we got serious about deploying the

paring a basic business case: identifying key

yearly commitments with measurable goals

program. We put together the infrastructure

assumptions and drivers, quantifying costs

and timeframes. Managers review these

using the LSS framework: We formalized our

of poor quality, and projecting savings or

commitments with their employees twice

Champion, developed a portfolio process

revenue based on improvements. We learn

a year.

(Figure 1) that uses a business alignment

how to prepare some basic metrics, such as

framework (Figure 2) to identify the right

return on investment, payback period and

heads facilitate workout sessions with em-

projects, and a portfolio tracking system to

break-even analysis.

ployee groups. One activity is called “start-

measure results. We customized the training around

The other program we started is a

At the beginning of the year, department

stop-continue.” We ask ourselves: “What

“decision-making boot camp” to help front-

should we—as an organization—be starting,

Cbeyond’s business, tailored tools that

line managers and directors make better

stopping and continuing?” There are always

would fit our needs, and provided ongo-

decisions. We educate participants on the

new ideas. Identifying the things we should

ing coaching and mentoring. Because our

three basic decision-making styles; problem-

stop doing is the most challenging part.

process excellence department is very lean

solving skills; decision-making tools (risk

Throughout the year, senior leaders

(only two Six Sigma Black Belts), we had

vs. uncertainty, calculating risk levels and

routinely conduct walkabouts—informal

to scale ourselves. We do this by formally

linking cause and effect) and conduct team

meetings with small groups of employees.

screening candidates who want to enroll

exercises based on actual Cbeyond issues.

They ask: “What are the top three things

in Cbeyond’s lean Six Sigma Green Belt

The other main challenge we face is

you’re working on?” Recognizing the need

certification program. One key criterion is to

maintaining our levels of energy, focus and

to keep momentum, our department heads

submit a project charter signed off on by the

commitment, particularly in the midst of

are starting to conduct weekly team reviews

candidate’s project sponsor. Projects must

significant change. Cbeyond is going through

with their teams, asking questions such as:

be completed within one year of training.

a major transformation with its products and

• What progress did we make this week?

This process ensures the right candidates

services. Employees want to know where

• What supported us and our work this

and projects are “pulled” into the program.

we’re going as an organization. They need

Employees are seeing things through a

to feel there’s a real commitment to the

new set of eyes, asking different questions,

destination and that the aspiration isn’t just

learning to challenge conventional wisdom

the “flavor of the month.”

through data and seizing opportunities. One of the most difficult challenges is get-

Perhaps most importantly, they need leaders to help them “connect the dots” so

week? • What setbacks did we have this week? How can we learn from them? • Did we affect our partners or customers positively this week? How will we do so next week?

ting employees to adopt a business mindset.

they know how their work supports the goal.

Let’s face it, a pile of numbers is just that—a

We’ve found that employees will bring more

a lot of energy, focus and commitment.

We’re not perfect by any means. It takes

pile. Without context—the surrounding

energy, focus and commitment to leaders

We’re in the third inning of a nine-inning

information—and analysis, they mean noth-

who can tell a compelling story about our

game. Like Brad Pitt said in the movie

ing. Putting things in context means asking

challenging journey from where we are to

“Moneyball”: “It’s a process; it’s a process;

questions such as: “What’s the problem we’re

where we want to be. There are lots of shiny

it’s a process.”

trying to solve? What’s the impact? How long

objects—new directives, different policies

has this been occurring? Where is it happen-

and technology. We can’t afford to chase

Director of process excellence

ing—internally or externally with our custom-

these shiny objects because we’ll waste

Cbeyond Communications

ers? What is the cost of doing nothing?”

time and resources.

Peter J. Sherman

Atlanta

May 2013 • QP

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RAM Dictionary

More than 2500 definitions. Great for any ASQ certification.

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

by Tracy Omdahl

Contains 2800 definitions. Helpful for Reliability and Quality Engineers.

ISO 9001 Internal Auditing Primer

ISO Primer by Bensley & Wortman

by Greg Wies & Bert Scali

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

Reliability & Maintenance Analyst CD by Bryan Dodson

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

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

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

ISO

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

Quality System Handbook by Edenborough

QSH

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

keepingcurre recalls

Back on Track

T

Yoga pants maker aims to put embarrassing recall behind it

The high-end athletic wear maker Lululemon thinks it has nipped its yoga pants problems in the bud, already implementing tighter testing protocols and oversight to prevent quality issues from rearing their ugly heads again. But many still point to Lululemon’s missteps that forced the recall of its black luon pants and crops as a reminder to never sit still with testing and quality processes, and always pay close attention to supply chain management strategy. “Everyone has (these issues), even big companies,” said Sam Poser, an analyst at Sterne, Agee & Leach brokerage firm. “But I don’t think it’s a supply chain issue per se. It’s a sitting-back-on-your-laurels issue and saying, ‘We’re doing it well enough.’ Usually these issues are symptoms of some sort of complacency. It happens to the best of companies.”1 Lululemon was forced to pull 17% of its yoga pants off store shelves in late March because the material proved to be too sheer. The embarrassing recall was first blamed on one of Lululemon’s suppliers, but the company later admitted that quality control was lacking and testing protocols were incomplete for some of the pants fabric in question.2 In a press release last month, Lululemon said it had already taken steps prior to the black luon fabric issue to bolster its internal product expertise, including the addition of senior-level capabilities in quality, raw materials and production. “This new team was instrumental in determining the root cause of the luon issue and has initiated three work streams to address what we believe are the contributing causes:” Testing and processes: A quality team is assessing all luon products in the production pipeline according to newly implemented

12 QP • www.qualityprogress.com

rigorous testing and quality processes that includes revised specifications for modulus (stretch), weight and tolerances. Factory oversight: Employees have been stationed in factories to monitor and test products and will educate internal teams and manufacturing partners on new testing standards and methods.

Leadership and structure: The company is building a stronger internal structure with new leadership and cross-functional team capability to create a more robust organization to 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 cost as much as $67 million, and shares of the company dropped 16% shortly after the recall news broke. It’s still uncertain how the brand’s value was damaged and whether Lululemon can gain back its customers’ trust.4

Attention on supply chain In today’s complex and elaborate retail environment, retailers must pay close attention to supply chain management strategy, analysts said. Retailers can sell products in brick-and-mortar stores, through mobile devices and on the Internet. These three points of distribution opens a lot of supply chain

risk that wasn’t there two or three years ago, said Megan Donadio, a retail strategist with the consulting firm Kurt Salmon.5 “Good supply chain management comes down to having a true partnership with key suppliers,” said Donadio. “You must actively manage your vendors and not let them manage you. That’s the real key to a good supply chain strategy.”6 Fast-growing firms such as Lululemon often face supply chain issues when products become very popular and create a strong demand. When that surge occurs, companies might not have a large supplier base to ensure quality products are made and delivered. “And if products aren’t in the stores, you risk disappointing what is a very loyal Lululemon customer,” said Brian Sozzi.7 When plotting out a supply chain strategy, companies must make sure they have enough suppliers to handle disruptions and mitigate risks, while also ensuring they’re not spread too thin across suppliers.8 REFERENCES 1. Marilyn Much, “Supply Chain Issues Send Retailers to the Drawing Board,” Investor’s Business Daily, March 28, 2013, http://news.investors.com/business-the-newamerica/032813-649686-lululemon-and-others-see-supplychain-issues.htm. 2. Tamara Rutter, “Lululemon Takes Responsibility for Failing Its Fans,” The Motley Fool, April 8, 2013, www.fool.com/ investing/general/2013/04/05/lululemon-takesresponsibility-for-failing-its-fan.aspx. 3. News Bites U.S. Markets, “Lululemon Gives Update on Production Issues,” April 5, 2013, http://asq.org/qualitynews/ qnt/execute/displaySetup?newsID=15724 (case sensitive). 4. Ashley Lutz, “Lululemon’s Stringent Return Policy is Hurting Its Business,” The Business Insider, April 4, 2013, www. businessinsider.com/lululemons-stringent-returnpolicy-2013-4. 5. Murch, “Supply Chain Issues Send Retailers to the Drawing Board,” see reference 1. 6. Ibid. 7. Marilyn Much, “Lululemon Luon Pants Fiasco Latest Supply Chain Issue,” Investor’s Business Daily, March 19, 2013, http://news.investors.com/business/031913-648541lululemon-athletica-pants-new-supply-chain-problem. htm?p=full. 8. Murch, “Supply Chain Issues Send Retailers to the Drawing Board,” see reference 1.

nt obituary

box, statistical giant, passes away George E.P. Box, considered by many to be one of the most influential statisticians of the 20th century, died last month at his Madison, WI, home. He was 93. Box was a pioneer in quality control, time series analysis, design of experiments and Bayesian inference, a statistical approach to problem solving. A native of Gravesend, England, Box earned a bachelor’s degree in mathematics and statistics. While pursuing his master’s degree, he began work at Imperial Chemical Industries and eventually became head of the statistical techniques research section of the company. He later served as visiting professor at the University of North Carolina and was at Princeton University as the director of its statistical research group. Box encouraged the creation of a journal devoted to statistics and statistical implications. ASQ and the American Statistical Association responded to his encouragement by creating Technometrics. In 1960, Box moved to Madison, where he was professor and first chairman of the statistics department at the University of Wisconsin (UW). His accomplishments in the field of statistics earned him ASQ’s Shewhart Medal in 1968. Box published numerous articles and papers, and authored or coauthored many books, including Statistics for Experimenters, Time Series Analysis: Forecasting and Control and Bayesian Inference in Statistical Analysis. Box was also professor emeritus at UW’s Center for Quality and Productivity Improvement. He was an honorary member of ASQ and a three-time recipient of ASQ’s Brumbaugh Award.

Q

Who’s Who in NAME: Ron Berglund. RESIDENCE: Canton, MI.

EDUCATION: Master’s degree in public health from the University of Michigan.

CURRENT JOB: Global quality coach, the Quality Guy, Berglund’s independent consulting company. INTRODUCTION TO QUALITY: Berglund used W. Edwards Deming’s Out of Chaos in 1980 to train his hospital staff at Saratoga Community Hospital in Detroit to improve processes and systems. PREVIOUS QUALITY EXPERIENCE: Quality director at Dexter Research Inc.; senior quality consultant for Omnex, assisting companies with Six Sigma implementation; assisted Volvo and ABB Robotics in China to develop their supply chains; adjunct graduate professor teaching graduate-level quality and healthcare courses for 16 years at the College of Extended Learning at Central Michigan University in Lansing. ASQ ACTIVITIES: An ASQ fellow, Berglund is a member of technical advisory group 176, Section 1000’s Ask the Expert group, a member of a team 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 Executives, Folmer Award member of the Healthcare Financial Management Association, and Canton, MI, precinct 38 delegate to select state candidates in general elections. PUBLICATIONS: Berglund has written several articles that have appeared in ASQ newsletters and publications. Most recently, Berglund updated the chapter “Conducting Successful Improvement Projects,” which he contributed to Hospital Epidemiology and Infection Control, fourth edition, published by Lippincott Williams & Wilkins in 2011. RECENT AWARDS: Distinguished Faculty of 2012 by the American College of 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 common sense is not very common.

May 2013 • QP 13

keepingcurrent AsQnEWs SECTION RENAMED ASQ’S Ozark Section 1413 has been renamed the Northwest Arkansas Section 1413 to better represent the geographic area it serves. TEAM EXCELLENCE FORMS Intent to submit forms for next year’s International Team Excellence Award are due July 1. For more information on the competition, visit http://wcqi. asq.org/team-competition/timeline. html.

asq global state of quality research

Quality not always centralized Quality isn’t usually governed and managed

quality group.

by an organization’s centralized quality group,

• 34% of respondents said they strongly

and measureable quality goals aren’t always

agree there are measureable quality goals

included in an organization’s strategy and

in their strategies and goals for manage-

goals for management and support services. Those are just a few results from ASQ’s Global State of Quality Research, scheduled

use quality metrics in variable perfor-

to be released during ASQ’s World Confer-

mance compensation.

ence on Quality and Improvement (WCQI)

LAB ACCREDITATION Environmental laboratories can now become accredited to TNI Volume 1 and additional standards through a single accreditation process offered by ANSI-ASQ National Accreditation Board/ACLASS. Environmental laboratories can be accredited concurrently by ACLASS to the NELAC Institute (TNI) Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis and to ISO/IEC 17025, the international standard for laboratory accreditation. For more information about the accreditation, visit www. aclasscorp.com.

14 QP • www.qualityprogress.com

ASQ partnered with the American Produc-

May 6-8 in Indianapolis. Some earlier results

tivity and Quality Center to conduct and man-

from the report include:

age the research and report. A special session

• 30% of respondents indicated quality

at WCQI to discuss and analyze the research

is governed and managed by a centralized ASQ QUALITY INSTITUTE ASQ is now offering a series of introductory quality courses July 15-17 at its headquarters location in Milwaukee. The ASQ Quality Institute will feature training not normally available in classroom settings. Courses include quality basics, integrated quality management, auditing for improvement, failure mode and effects analysis, and corrective and preventive action. Visit www.asq.org/promotional/milwaukee for more details on the courses, instructors and special registration offers.

ment and support services. • 14% of respondents strongly agreed they

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

MANUFACTURING

SURVEY: MIDSIZED MANUFACTURERS EXPECT GROWTH IN REVENUES IN 2013 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, with 68% 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. Healthcare costs moved back into second place among top cost-pressure concerns, with 57% of respondents including it in the top three. “We are encouraged to see that our members expect to see growth in 2013, after a very strong 2012 for most,” Louise O’Sullivan, founder, president and CEO of Prime Advantage said in a prepared statement. “As they focus on profitability and margins, we look forward to partnering with both members and endorsed suppliers to fuel the bottom line, reflecting total cost of ownership, along with the top line, greater sales and market share.”

ASQ Journal spotlight

Software Quality Professional

Every month, QP highlights an open-access article from one of ASQ’s seven other journals. This month, make sure you read “Value of ISO 90003 Customer Requirement Guidelines to Improve IT Project Success,” which appeared in December’s edition of Software Quality Professional (SQP). The article, written by Kaali Dass, is based on a quantitative study conducted by nine Project Management Institute chapters around the world to measure perceived value of IT project success. To access the article, click on the “Current Issue” link on SQP’s website: http:// asq.org/pub/sqp. From there, you also can find a link to information about subscribing to the quarterly publication. V O L U M E

F I F T E E N

•

I S S U E

T W O

•

M A R C H

Software Quality Costs Edited by Taz Daughtrey

Mobile Metrics: Measuring the Accessibility of Web Contents on Mobile Handsets Kalpana Johari and Arvinder Kaur

A Scrum Adoption Survey Mark Paulk

Data-driven Estimation, Management Lead to High Quality Kate Armel

www.asq.org

2 0 13

Mr. Pareto Head

By Mike Crossen

baldrige program

long-time director hertz to retire Harry S. Hertz, director of the Baldrige Performance Excellence Program since 1992, has announced his retirement and will leave the post on June 3. Deciding to retire in the program’s 25th year, Hertz said he “thought that was sort of a good transition point for me and the program. The program has had two leaders in its 25 years. It seemed like a good time for me to do something new and for the program to have some fresh thoughts and leadership.” Hertz said he considered the program’s expansion from strictly covering manufacturing and service sectors to including education, healthcare, nonprofits and government arenas as one of the program’s biggest accomplishments while he was at the helm. The program is no longer viewed as simply an award and has become one of the standards of excellence organizations around the world strive to achieve. The Baldrige criteria are being practiced in nearly 90 countries, Hertz said. “We’ve changed from strictly an award program to a national educational program,” Hertz said. “It’s really about education and learning and helping to improve performance broadly.” One of the program’s biggest obstacles during Hertz’s tenure happened when the federal government decided it would no longer contribute funds to the program’s budget. That meant there was a $9.6 million hole in the program’s budget in 2012. But the program and its partners—including the Baldrige Foundation, the Alliance for Performance Excellence and ASQ, which administers the program—regrouped and developed a different business model and plan to maintain operations and continue the program. “I think we’re through the transition now,” Hertz said. “It was tough.” Hertz said he isn’t sure what the future holds for him. He has three growing grandchildren who will keep him busy, but he doesn’t want to lose touch with the Baldrige program, 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 lot to offer. I want to continue in some capacity—working with the program and the wonderful people on staff, as well as in the community that has engaged in Baldrige through the years. I’ve always been very interested in education, and so I’d like to do some teaching, as well.” The Baldrige Program is in the process of seeking a successor. The job has been posted on the www.usajobs.gov federal hiring website.

WordtotheWise To educate newcomers and refresh practitioners and professionals, QP occasionally features a quality term and definition:

Right size Matching 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 fits into an overall vision for workflow through a 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.

CORRECTION In the March 2013 Quality in the First Person column, “Show and Tell” (pp. 48-49), author Marcia M. Weeden was misidentified as the chair of the ASQ’s Olde Colony Section. She is the section’s voice of the customer chair. QP regrets the error.

May 2013 • QP 15

Balancing

Act

Collaboration reduces risk in quality data management by Eda Ross Montgomery and Justin Neway

data MANAGEMENT

Quality has long been an initiative, a goal and—especially in regulated industries—a requirement for staying in business. Today’s 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 corporate and global boundaries. Standards, such as ISO 9001, have been widely adopted to minimize risks to consumers. The ISO 9000 series of standards have been interpreted to fit specific requirements in various industries—from automotive and aerospace manufacturers to telecommunication and software providers. These tools are in the early stages of being adopted in the pharmaceutical industry as part of the implementation of quality by design (QbD). In parallel with implementing risk-reducing quality improvements, it is important to also undertake a technical evaluation program 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. Overwhelming 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 Words Or Less

• International standards organizations recommend that life sciences manufacturers implement quality by design, making data management central to an organization’s quality strategy. • The collaboration of quality and manufacturing teams to understand and analyze data to improve processes, along with the use of technology, can help an organization reduce risk.

May 2013 • QP 17

Global pharmaceutical manufacturers sometimes re-

ket when quality lies outside an initial acceptance range

fer to data silos, such as corrective and preventive action

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

(CAPA) systems, laboratory information management

other end holds process manufacturing-based products

systems (LIMS), enterprise resource planning, manu-

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

facturing execution systems, data historians and paper

variance exists.

records. When quality and manufacturing teams investi-

Until recently, larger margins on products that made

gate a problem using data from multiple siloed systems,

it to pharmacy shelves compensated for large numbers

the result is often spreadsheet madness, which leaves in-

of lost batches. But recent market forces have created

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

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

may not even pinpoint the problem.

ences manufacturers to invest in measures to reduce pro-

An added challenge is the lack of collaboration among most manufacturing and quality teams when it comes to

cess variability, increase yield, and improve quality and robustness.

data management. The online sidebar, “Signs of Trouble,”

Economic factors, such as fewer blockbuster drug

which can be found on this article’s webpage at www.

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

qualityprogress.com, describes four additional indica-

ing the life sciences industry’s need to control variability

tors that suggest an organization’s quality data manage-

to reduce manufacturing risks and supply chain costs.

ment system needs improving.

Regulators are helping with recommendations, such as

Establishing shared goals and a mutual understanding

QbD, that present an opportunity to improve manufactur-

of the problem can help overcome the practical difficul-

ing processes based on new real-time process measure-

ties of accessing process development and manufactur-

ments and by taking advantage of previous experiences

ing data from separate databases and paper records.

with similar processes.

When collaboration occurs, significant paybacks result

A decade ago, process analytical technology was intro-

from connecting to data in real time for trending analysis.

duced by the U.S. Food and Drug Administration (FDA) as a mechanism for improving real-time process control

Life science drivers

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

The life sciences industry serves as an interesting example

technology processes. Since then, the volume of electron-

because it is relatively behind the curve when it comes to

ic and paper-based data collected during process devel-

reducing risk through the management of quality data. Ac-

opment and manufacturing has increased dramatically.

cording to Pharmaceutical Technology’s Equipment and

With risk reduction and improved product quality in

Processing Report: “The industry’s approach to risk is more

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

sophisticated now, but still

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

has room for improvement

processes that make life sciences products have quality

… Drug companies some-

designed into them rather than just involving testing the

times lack certain capabili-

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

Continuum of manufactured goods / figure 1 Adverse consequences of low quality

High

Pharmaceuticals

ties that could help enhance

Regulators encourage collaboration among manufac-

product and process knowl-

turing and quality teams with guidelines that integrate the

edge.”1

industries,

two areas. In its 2008 Q10 document, the International

such as food and beverage,

Conference on Harmonization of Technical Requirements

and specialty chemicals, are

for Registration of Pharmaceuticals for Human Use (ICH)

further along and operate

said, “ICH Q10 demonstrates industry and regulatory au-

with smaller profit margins.

thorities’ support of an effective pharmaceutical quality

Other

Imagine a continuum of manufactured goods (FigTextiles to discount retailers

Low Low

Ability to repurpose product

18 QP • www.qualityprogress.com

High

system to enhance the quality and availability of medicines around the world in the interest of public health.

ure 1). One end includes

Implementation of ICH Q10 throughout the product

products that are still sale-

life cycle should facilitate innovation and continual im-

able when variance occurs.

provement and strengthen the link between pharmaceuti-

These items can be repur-

cal development and manufacturing activities.”2

posed for an identified mar-

ICH Q10 outlines a quality management system

data MANAGEMENT

model—the Pharmaceutical Quality System—and states

a combined or unified process-centric view of product

that “implementation of the Q10 model should result in

development, quality and manufacturing across the IT

achievement of three main objectives which comple-

systems. This shift in thinking must be made attractive to

ment or enhance regional good manufacturing practice

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

requirements”:3

oned by those who value a shared purpose between qual-

1. Achieve product realization: supports operation of

ity and manufacturing teams.

processes that meet appropriate quality attributes.

As another example, annual product reviews (APR)

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

typically are quality’s responsibility, and they are organized

ables risk-based monitoring and control systems for

around individual drugs. In a more collaborative environ-

process performance and product quality, providing

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

assurance of continued suitability (for example, the

ciple for data. Information about specification failures and

ability for the process to continue producing the in-

process deviations is shared among the combined process

tended outcomes) and capability of processes.

development, quality and manufacturing teams.

3. Facilitate continual improvement: strengthens the

A quality team might see trend charts and ask how the

knowledge or data link between development, manu-

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

facturing and quality.

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

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

es and reorganize it using error-prone manual methods.

ity management and risk reduction. “It was decided to go

An added complexity is that different quality teams

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

often have different data languages that result from their

product life cycle,” explained Joseph Famulare, former

unique needs and make it impractical to organize the data

deputy director of the Office of Compliance in the FDA’s

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

Center for Drug Evaluation and Research. “The result is

the different data languages used by quality teams with

that firms that employ QbD and use risk-management

varying priorities is when one team uses deviations as a

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

driver for batch release and another team uses control

system to manage change and continual improvement,

charts as a driver for change control.

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

The increased use of contract manufacturing organiza-

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

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

manufacturer,” he said.4

cans take are currently manufactured outside the United States) increases the challenge of achieving this unified,

Intersection of quality and manufacturing

process-centric view across all aspects of the organiza-

When manufacturing organizations implement quality im-

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

provement initiatives, quality and manufacturing teams

all aspects of sponsor and contract or supplier organiza-

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

tions are aligned on the strategy and tactics for ensuring

most quality systems are designed to serve the needs of

ongoing product quality.

the quality team, such as verifying assessments and pub-

Quality can’t execute on its own without the ability

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

to collaborate in a world where teams share a common

making a manufacturing process more successful.

language (data and facts in context) organized around a

Collaboration in the name of quality data management

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

requires a paradigm shift that organizes data around the

vestigators also might need to know characteristics of the

manufacturing process and resulting product control

previous process step or input material before they will

strategy, rather than around samples, control of analytical

be able to recommend appropriate action.

workflows, control of standards and analysts—the current organizing principles on which LIMS are based. For example, results may be posted and verified about the selenium content of a particular sample, but why would someone want to see the data for an individual sample? Ultimately, the goal is to better control the process that produces the samples, so there needs to be

Critical success factors include providing end users with on-demand access to data in a collaborative analytics, trending and reporting environment in which the multidisciplinary 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.

May 2013 • QP 19

• A practical way to capture paper-based data and make it easily available in electronic form.

validation guidance.9

• The ability to work with continuous and discrete data

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

together, sharing data, analysis results and reports

lytics should work with quality assurance data systems to

across disciplines, scales of operation and geographi-

enable and support ICH Q10 product life cycle manage-

cally dispersed sites.

ment goals in the following areas:10

• Simplifying the preparation and distribution of analysis results.

of electronic data), audit-trailed capability to capture

reports of batches and campaigns.

paper-based data in electronic form in a network-

The ICH Q10 process performance and product quality

accessible database available to all users; enable

monitoring system section says: “Pharmaceutical compa-

centralized experts to prepare and distribute outputs

nies should plan and execute a system for the monitor-

for widespread use and updating by globalized teams

ing of process performance and product quality to ensure

of diverse, nonstatistical users; provide a collabora-

a state of control is maintained. An effective monitoring

tive data access and analytics platform that spans

system provides assurance of the continued capability of

geographic and organizational boundaries (between

processes and controls to produce a product of desired

sponsors and CMOs) so teams with shared concerns

quality and to identify areas for continual improvement.”

6

can achieve their joint goals.

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

• Process performance and quality monitoring.

textualization and reporting, will work with existing qual-

Provide observational users an updated portal or

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

dashboard to display status data anywhere, anytime.

quality and manufacturing systems and provide access to

Simplify and reduce the cost of periodic quality re-

the necessary data.

view, APR and production report preparation and

In October 2010, the International Society for Pharma-

distribution; provide views of test method processes

ceutical Engineering (ISPE) released “Overview of Product

to study and reduce test method variability; provide a

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

collaborative platform for comparison of internal and

Based Approach to Implementation.” According to Phar-

Collaboration tools / CAPA

MES

figure 2 HIST

Collaboration tools (Data aggregation, analysis, contextualization and reporting)

• CAPA. Provide a link between customer-complaint

product quality life

data and product testing and production data to un-

cycle implementation

derstand cause-and-effect relationships; enable a link

initiative has been

between process development and manufacturing

one of the leading

sample testing to make comparisons; enable testing

efforts to translate

and implementation of process improvements.

ICH guidance on sci-

• Change management. Provide a platform for imme-

ence and risk-based

diate access, organization and flow of data for inter-

manufacturing

CAPA = corrective and preventive action HIST = data historians LIMS = laboratory information management systems MES = manufacturing execution systems

20 QP • www.qualityprogress.com

into

nal communications.

more practical lan-

• Management review. Provide management users an

guage and to outline

updated portal or dashboard to display status data

how Q8, Q9 and Q10

anywhere anytime; provide easy access to and organi-

might be applied by

zation of data for timely preparation of management

industry.”7

reports; provide a collaborative platform to enable

Meanwhile,

Manufacturing

outsourced operations and quality data.

maQbD.com, “ISPE’s

the

staff to implement management actions.

Society

An example of how a global life sciences manufac-

for Testing and Ma-

turing company with a quality trend monitoring system

terials is developing

met these criteria while implementing a paradigm shift

standards

American Quality

• Global. Provide a Part 11 compliant (a Code of Federal Regulations requirement for integrity and security

• Automating the generation of periodic reviews and

LIMS

es to implementing ICH Q8-108 and the FDA’s process

in-

for collaborating to achieve multi-year initiative goals

dustry that provide

is discussed in the online sidebar, “A Life Sciences Case

practical approach-

Study.”

for

data MANAGEMENT

Tips for success

tivities between sponsor companies and CMOs.

Based on first-hand practical experience, the top five

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

tips for change management with quality and manufac-

agement structures and technology. A collaborative ap-

turing teams include:

proach that meets ICH Q10 guidelines and adds a data

• Minimize time requirements. No one resists the

access contextualization layer over existing technology

concept of quality trend monitoring, but some fear the

systems can improve overall quality data management.

perceived effort and time it might take. It is important

Spreadsheets and paper records will never be com-

to reserve the time needed for initial benchmarking and

pletely eliminated, but the right technology system helps

conduct ongoing collaborative data analysis.

significantly reduce the errors and risks associated with

• Centralize. Having a central project group to relieve

these components. It enables companies to leverage ex-

the workload and evangelize the approach can drive suc-

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

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

quality and manufacturing to support important risk miti-

baseline analysis to minimize the burden placed on other

gation initiatives. QP

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 producing 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 related data into groups or “batches” in preparation for analysis is a massive time-saver. While monthly analysis is a minimum requirement to ensure that trends in high-volume products are identified and controlled, technology tools allow the option for daily updates

References 1. Erik Greb, “Moving From a Reactive to a Systemic Approach to Manage Risk,” Pharmaceutical Technology Equipment and Processing Report, Dec. 21, 2011, http://pharmtech.findpharma.com/pharmtech/Online+Only/Moving-from-aReactive-to-a-Systemic-Approach-to-/ArticleStandard/Article/detail/752605?co ntextCategoryId=40939 (case sensitive). 2. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, “ICH Q10,” 2008 www.ich. org/fileadmin/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,” Pharmaceutical Technology, Sept. 2, 2007, http://pharmtech.findpharma.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 FDA’s Screening Efforts at the Border,” testimony before the U.S. House Subcommittee on Oversight and Investigations, April 13, 2011, www.fda.gov/newsevents/testimony/ucm250710. htm. 6. Greb, “Moving From a Reactive to a Systemic Approach to Manage Risk,” see reference 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 Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment,” www.astm.org/Standards/E2500.htm (case sensitive). 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,” see reference 1.

due to reduced cost and effort requirements. Quality and manufacturing teams can apply these lessons for better quality data management. Ultimately, life sciences companies can use up-front analysis to identify continuous improvement opportunities by identifying the

Eda Ross Montgomery is senior director and technical steward at Shire in Wayne, PA. She has a doctorate in analytical chemistry from the University of North Carolina in Chapel Hill.

products with the least acceptable outcomes (for example, 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 monitoring program. The same approach can be used to develop

Justin Neway is vice president and chief science officer of analytical, development, quality and manufacturing solutions for Accelrys in Boulder, CO. He has a doctorate in biochemistry from the University of Illinois in Champaign.

joint goals and implement continuous improvement ac-

May 2013 • QP 21

Avoiding an

Avalanche In 50 Words Or Less

• Organizations can be overwhelmed by an avalanche of information and documentation, which can lead to process inefficiencies and lost productivity, as well as increased risk and liability. • Centralized electronic document and data control processes within a quality management system help organizations manage critical and sensitive content and make more informed decisions.

Proper control of documents and data within a QMS will reduce risk and liability by Greg Milliken

data management

ORGANIZATIONS THAT MAKE products with rigorous quality requirements face numerous challenges associated with meeting objectives—ranging from complying with standards (such as ISO 9001 and current good manufacturing 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 information control as a core component of their quality management systems (QMS). The result can range from organizational inefficiencies and poorly allocated resources to negative brand perception, lost revenue and increased liability.

May 2013 • QP 23

Without a centralized and organizationwide ap-

it’s time to consider incorporating a formal electronic

proach to managing information, organizations leave

content control solution into your QMS:

themselves vulnerable because of the difficulty and

• Who is the gatekeeper? A manual quality process

complexity of managing critical and sensitive content

often revolves around one person who manages all

and processes that affect quality and compliance. On

essential quality-related documentation. What hap-

the other hand, organizations that adhere to a pragmat-

pens if this person stays home sick, takes vacation

ic, day-to-day approach to managing quality information not only operate at a vastly superior level, but also reduce risk and liability.

or leaves the organization? • Where does all of our documentation reside? Quality management is information-intensive, and

Establishing document and data control processes

the number of associated documents can grow ex-

within a quality management framework improves

ponentially over time. Many quality-related records

manufacturing and production processes, enhances

require approval by signature, which traditionally

collaboration, optimizes the use of existing resources,

has meant storing paper-based documents in physi-

and drives organizational efficiencies that affect an or-

cal file cabinets. In a manual paper-based quality

ganization’s bottom-line business objectives.

environment, it’s difficult to find documents and

To better understand how information control is an

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

integral component of quality management, you must

cords. There’s also a significant investment in stor-

recognize the challenges associated with manual qual-

age space to maintain essential documentation.

ity processes, the types of content typically managed

• Did you get that email? It’s often difficult to get

within a QMS, how data management can improve

up-to-date information about the state of quality

compliance-related activities, and how an effective

documentation and processes because related in-

solution for information control can significantly im-

formation and communications often are dispersed

prove quality systems and processes.

among unrelated collections of paper documents, electronic files and emails. In this environment, it’s

Challenges of manual quality processes

almost impossible to get a quick answer to a simple

For many organizations, data and document control

question such as, “Have the required people read

processes are managed separately by different depart-

the new instructions we approved two weeks ago?”

ments. This proves ineffective as individuals in one

• How are quality processes managed? Many or-

department lack visibility into important information

ganizations have instituted quality policies featur-

control procedures implemented within other depart-

ing specific repetitive tasks such as weekly system

ments.

health checks, periodic maintenance, monthly data

In addition to the challenge of coordinating often

recovery tests or regular standard operating proce-

disparate electronic data management methods, the

dure (SOP) reviews. Organizations, however, often

problem is frequently exacerbated by the use of archa-

find it challenging to actually ensure these tasks are

ic, manual processes for storing and organizing critical

completed on time and according to policy guide-

documentation in physical file folders.

lines because only a limited number of people (of-

Manual information control procedures are errorprone, and may inadvertently compromise an or-

ten one) have visibility into how quality processes are managed.

ganization’s ability to comply with regulations and

• Have quality issues been resolved? Audits, in-

standards such as cGMP and ISO 9001. Furthermore,

spections and normal daily operations produce dif-

organizations also can incur high costs because of the

ferent kinds of issues, nonconformities, audit find-

excess time and resources needed to manually manage

ings and protocol deviations. Manual quality issue

documentation required to maintain compliance and

management is not only tedious, but it’s also error-

mitigate operational risks.

prone and tends to deteriorate over time. Qual-

The manual approach to document and data control

ity managers can do little other than send endless

is rife with flaws that can negatively impact the integ-

email reminders and make follow-up phone calls

rity of an organization’s QMS. If the following ques-

about pending corrective actions.

tions are being asked frequently at your organization,

Today, more manufacturers realize that to mitigate

24 QP • www.qualityprogress.com

data management

Organizations can incur high costs because of the excess time and resources spent manually managing documentation. risk associated with production processes and proce-

zations also should define additional categories and

dures, an effective information management system

subcategories based on the specific types of informa-

must be implemented. Modern content management

tion they produce during the course of business. For

solutions deliver high levels of management and con-

instance, subcategories of “product design and devel-

trol, empowering organizations to improve productiv-

opment” may include specifications, drawings or bills

ity, reduce production costs, ensure compliance and

of materials. Examples of subcategories for “person-

reduce risk.

nel” could be employee reviews and manuals and training certificates.

Content categories within a QMS Manufacturing organizations produce an overwhelm-

A global environment

ing amount of information. Adequately managing

Regulated organizations that maintain paper-based

inspection sheets, audit reports, nonconformance

systems are falling behind, and the reason for the lag

documents, corrective and preventive actions (CAPA),

is quite evident. Quality systems based on paper docu-

customer complaints and inquiries can be a daunting

ment control processes put organizations at a competi-

and resource-draining task.

tive disadvantage. Paper-based systems significantly

When integrating a solution for document and data

increase the risk of noncompliance with cGMP in regu-

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

lated organizations or by those seeking to comply with

is to define the categories of documents that exist (or

the standards or regulations established by the U.S.

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

Food and Drug Administration (FDA), the European

egories are defined, more specific types of information

Union (EU), the International Organization for Stan-

within each category also can be defined.

dardization (ISO) or other bodies.

The goal of identifying specific data categories is to

Data are generated by the day-to-day activities that

paint a comprehensive picture of how a product was

take place in each department. Regulatory operations

designed, what decisions were made during the pro-

personnel, for example, produce documents and de-

cess (including why certain alternative designs were

velop submissions, which they file for approval. A sub-

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

mission begins long before the documents are created,

ing was reasonable and adequate. Another important

however. In most cases, data gathering is conducted

goal is to show how an organization responsibly pro-

locally, with responsible departments drawing on the

cesses and responds to complaints and mishaps.

information needed to adhere to regulatory require-

The following are examples of broad content categories organizations typically establish within their

ments or to track commitments. What is often missing is the ability to aggregate in-

QMSs:

formation across the enterprise so it can be used to

1. Product design and development.

conduct more predictive work, such as project plan-

2. Manufacturing and quality control.

ning across the portfolio, resource planning, and pre

3. Merchandising.

and post-launch marketing activities. In so doing, orga-

4. Service and installation.

nizations can manage their activities more holistically

5. Complaints and mishaps.

and better equip themselves to recognize and act on

6. Personnel.

information that can affect operations.

7. Management and coordination. In addition to these general classifications, organi-

Clearly, regulatory information management involves far more than just tracking submissions. The

May 2013 • QP 25

processes and technologies employed to enable suc-

impact on productivity due to a reliance on manual

cessful regulatory information management also help

processes, an ever-increasing demand for inefficient

organizations to consolidate their disparate systems

physical storage, and the risk of losing the signed origi-

and produce meaningful information that leads to bet-

nals due to a disaster. For these reasons, many organi-

ter decision making.

zations use electronic and digital signing capabilities.

The starting point is managing and structuring data

These two methods of signing are similar in that

clearly and consistently. Only by having clean, consis-

they are legally binding and meet compliance require-

tent and reliable data is it possible to build a broad pic-

ments. Common documents typically requiring signa-

ture of how an organization’s resources are currently

tures include:

being used and how they can be maximized in the fu-

• Organization SOPs, instructions and guidelines.

ture.

• Training certificates and self-learning forms.

Complete, accurate and clear documentation is the key to maintaining compliance in a cGMP environment. Accurate and updated information is needed to establish quality management principles, describe specific processes and procedures, and maintain records that demonstrate such processes and procedures were followed. Together, these principles, processes, procedures and records show a manufacturer is operating in a controlled state, defined as “a condition in which the set of

• HR documents, such as I-9 forms, annual performance reviews and training certificates. • Periodic maintenance tasks, quality checks and change logs. • Request approvals (for example, authorizing access to an IT system or organization premises). • Documents related to CAPAs based on deviations or audit findings. • Industry-specific document types, such as those associated with monitoring reports for clinical trials.

controls consistently provides assurance of continued process performance and product quality.”1

Electronic vs. digital signatures

Electronic information management systems pro-

There are two primary methods for signing docu-

vide a framework for centrally organizing, managing

ments that are stored electronically that are legally

and tracking important data and processes. In addi-

binding for general contracts and agreements, as well

tion, they support lean manufacturing practices and

as sufficient to ensure compliance with regulations

quality management programs that ensure efficient

and industry standards. The two methods, electronic

processes that comply with government regulations

signing and digital signing, sound similar, and indeed

and industry standards.

have some similarities, but there are also distinct differences that are often misunderstood. For electronic

Signatures in a paperless world

signatures:

It is common in many business environments for

• The proof of the signature remains in the system

important electronic files to be stored on a shared network drive, or increasingly, in an “on-premise” content repository or web-based portal. When it’s time to approve or authorize a document requiring a signature, however, it is still far more common that

where the signature is captured. • They work for printable documents and database records. • They support one or multiple signatures per document.

it is printed and signed with a pen. Thus it starts a

• The system capturing the signature also can link the

new life as a hard copy that has to be stored and man-

signed document or database record to a record for

aged manually. This need for handwritten signatures

the individual signers.

keeps many organizations stuck with paper-based processes. It’s easy to understand why traditional handwritten

For digital signatures: • The proof of the signature is embedded in the signed document.

signatures are still so widely used. They’re legally bind-

• Only one signature per document is allowed.

ing and, psychologically, they just feel right. Signing

• They are supported only for printable documents,

documents with a pen leads to serious process issues, however, including a lack of file control, an adverse

26 QP • www.qualityprogress.com

not database records. • The system capturing the signature also can link

data management

The need for handwritten signatures still keeps many organizations stuck with paper-based processes. the document to the originating entity of those who

Enhancing quality management

signed the document, even when a copy is sent out-

Information management is a critical component of

side of the organization.

any QMS. GMP/cGMP, FDA regulations, ISO qual-

The benefit associated with both methods of signing

ity management standards, and other regulations and

include time savings: They eliminate the need to send

standards require organizations to manage file ver-

originals via mail between offices, time is no longer

sions, document and execute SOPs, control employee

inefficiently spent on “print-sign-scan” processes, and

access, facilitate training initiatives and implement ap-

signed original documents can be located in seconds.

propriate change control procedures for all organiza-

Both types of signing also support quality processes and compliance in the following ways:

tional information. To be competitive in today’s global marketplace,

• Accompanying time stamps cannot be forged.

it’s paramount to have a tightly integrated and com-

• Only authorized personnel can sign.

prehensive solution for managing and controlling in-

• They are easier to read or interpret (including the

formation across the enterprise from within a single,

computer-generated signature page).

centralized repository. When documents and data can

• They provide easy access to one signed original all

be searched, viewed and managed across multiple, in-

of the time for all purposes, eliminating the risk of

tegrated systems, efficiency is optimized as organiza-

using outdated versions or losing hard-copy origi-

tions streamline workflow processes and reduce costs.

nals.

With an effective approach to information manage-

Finally, electronic or digital signatures improve

ment integrated within a quality management frame-

support for disaster recovery and business continuity.

work, organizations can control and regulate docu-

Signed originals can be easily maintained and secured

ment access, improve visibility and control revisions

via backup and data replication with redundant stor-

across multiple departments, while also providing

age systems in different physical locations.

the necessary level of automated notifications and

It is also possible to capture and manage electronic

communication to those people who are affected by

versions of traditional handwritten signatures. In a

the changes. This, in turn, simplifies compliance pro-

typical scenario, an electronic document is approved

cedures, optimizes processes, automates information

in a workflow, printed, signed and scanned with optical

exchange and reduces administrative overhead. As a

character recognition (OCR) and stored electronically.

result, teams can work more effectively and efficiently,

This process also can fulfill FDA requirements as long as

keeping personnel connected, informed and on task,

th system prevents modifications to the electronic docu-

providing access to the right information to anyone at

ment after it has been stored. While this approach offers

any time, from anywhere. QP

a number of benefits associated with eliminating certain manual processes, it still involves the undesirable and inefficient “print-sign-scan” process. There are a variety of tools on the market for eas-

REFERENCE 1. U.S. Food and Drug Administration and International Conference on Harmonization, “Guidance for Industry—Process Validation: General Principles and Practices,” January 2011, p. 18, www.fda.gov/downloads/drugs/ guidancecomplianceregulatoryinformation/guidances/ucm070336.pdf.

ing the transition to a paperless—or at least more paperless—world. Handling signatures is an important element, so be sure to evaluate the options for electronic and digital signatures supported by systems you consider to help you on the journey

GREG MILLIKEN is the president of M-Files Inc. in Dallas. He holds a bachelor’s degree in mechanical engineering from the University of Texas at Austin.

to a more efficient and productive business that is less reliant on manual and paper-based processes.

May 2013 • QP 27

What Makes

You Tick?

PROCESS IMPROVEMENT

Coordinate your organization’s inner workings to optimize efficiency and lower costs

by H.F. Ken Machado

every organization has several customer support activities that continually take place and involve more than one operational function. Because the response times among these corporate functions can vary, the task of internally managing the functions is complex and can result in issues that must be continually addressed. The sales function is in continuous contact with the customer base and general market, so the response to market requirements and changes is nearly immediate (one to two weeks).

In 50 Words Or Less

• Uncoordinated internal operations create organizational inefficiencies, a lower level of customer service and unnecessary delays in management decisions, resulting in increased costs. • A cross-functional process management system can help organizations break through operational logjams, allowing business functions to work together to effectively perform co-dependent business requirements, thereby improving business performance.

May 2013 • QP 29

The marketing function works with the customer

the assigned staff members are preoccupied and busy

base to determine new product requirements and to

working on the individual priorities set by each sepa-

orchestrate the introduction of new products. To ac-

rate functional manager.

complish this task, the marketing function must work with the internal engineering function, so the response

Symptomatic patterns

time required may be four to eight weeks.

Because functional planning horizons vary and market

The operations function includes order planning

demand changes are so dynamic, the functional de-

(two to three weeks), material procurement (two to

partments involved must meet regularly to coordinate

10 weeks), product manufacturing (one to four weeks)

their individual plans. The purpose of the joint meet-

and delivery (one to two weeks).

ings is to reconcile the built-in planning or reaction

The total lapsed time for operations, therefore, can

time needed to maintain the organizational marketing

range from six to 19 weeks, and the required response

plan. Often, there must be additional co-dependent

time by function can vary considerably, as shown in

work meetings to maintain ongoing control of compos-

Table 1.

ite customer and market response requirements.

Evidence that the difference in response time

This approach stretches the resources involved in

among business functions can be problematic for orga-

updating and maintaining the commitments made to

nizations is illustrated by internal signs and symptoms

individual customers and the overall marketplace. Be-

that together form an identifiable pattern. This symp-

cause of these demands, the functional staffs involved

tomatic pattern frequently occurs when large organiza-

spend more time maintaining the status quo rather

tions place a high volume of their top business priori-

than pursuing more proactive process improvement

ties into separate sets of functional queues.

tasks.

Because the staff members involved in accomplish-

Functionally independent priority systems are

ing these objectives are in different corporate func-

equally counterproductive. Process hand-off tasks

tions, the co-dependent functional managers end up

must be orchestrated among functions at the appro-

in a corporate gridlock of independent queue priority

priate process junctions. This continuous process

systems that are being serially processed. We call this

requires the dynamic management of the various co-

condition corporate queue paralysis (CQP).

dependent functional responsibilities. A more pro-

CQP describes a circumstance within large orga-

ductive approach would be to work under a common

nizations in which many of the top-level process re-

cross-functionally coordinated priority management

quirements get placed into separate sets of priority

system.

management queues. This syndrome occurs because organizations with a diverse set of functionally spe-

Long-term solution

cific activities tend to naturally operate independently

Applying the principles of cross-functional manage-

rather than in a coordinated, process-controlled envi-

ment will break organizational logjams and improve

ronment. The situation often goes undetected because

overall corporate performance going forward. To resolve the CQP dilemma, five basic operational steps

Required response time by function / Table 1 Response time/weeks Sales function

are required to develop and maintain a robust crossfunctional priority management system: 1. Develop a single overall flow process of the crossfunctional events involved. This should be performed by a seasoned cross-functional specialist

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19

(CFS) and should be built around the concepts of

1-2

parallel activities, low process latency (a delayed

Marketing function Operations function

30 QP • www.qualityprogress.com

reaction between stimulation and response) and de4-8

cision making, which promote progress per unit of time. These are a vital set of requirements when the 6-19

decision-making process is supported by an information-based workflow system.

PROCESS IMPROVEMENT

2. Draft a common procedure that encompasses the

Developing the procedure

needs of the functions involved. This requirement

Next, the CFS drafts the initial version of the sequen-

also should be performed by the CFS, who should

tial steps in the process. Usually, there is at least one

be a well-qualified professional with substantial

paragraph of text needed to describe each sequential

process improvement experience—often an indus-

task in the overall process.

trial or quality engineer, or process improvement specialist.

During the development of the procedure, the CFS frequently consults with each of the internal functional

3. Assign process owners, or principals, for each func-

participants to ensure buy-in. The procedure is de-

tional entity and indoctrinate each about the need

signed around the recommended ISO 9001 document

and purpose for the cross-functional management

format structure and the requirements to document

plan.

process inputs and outputs. This is done for two rea-

4. Have senior management review, approve and pub-

sons: The ISO 9001 format has proven over time to be

lish the overall cross-functional process and proce-

easy to follow and understand, and the resultant docu-

dure in the organizational process control system.

ment is properly formatted for organizations that seek

5. Require process owners to manage, monitor and modify cross-functional process steps to drive continual improvement.

ISO 9001 certification. Developing the procedural text requires adding important detail that may have been left out of the initial flowchart. For that reason, the flowchart is updated by

Developing the process flow

the CFS over the course of time it takes to complete

An overall process-oriented approach is required to de-

the draft. After completion, the text and the updated

fine the complex cross-functional set of sequential re-

flowchart are distributed for review by all involved in

quirements. This must be constructed by experienced

the development process.

personnel who are able to balance low process latency

After responding to any email requests for input or

with effective levels of participation, decision making

clarity, the CFS calls a meeting of all the major con-

and ownership.

tributors. The purpose of the joint contributor meeting

The first step is to develop a preliminary overview

is to clarify and gain a common understanding of the

flowchart of the events required, covering the front-to-

overall process and to identify any new thinking and

back sequential cross-functional steps and the corre-

changes in the existing practices. The longer-term ob-

sponding responsibilities of each process step.

jective is to follow the new and improved process the

Reviewing the overall process with the individual

correct way the first time.

cross-functional principals requires perseverance

After the meeting, the CFS follows up each indi-

because a good deal of exchange and guidance often

vidual corrective action required until all the identified

must be provided to ensure all the participants in-

issues are satisfactorily resolved.

volved are on the same page. The success of this exercise pivots on the overall

Designating the process owners

front-to-back continuity of the cross-functional pro-

In today’s business environment, every important com-

cess. Therefore, gap analyses must be continually per-

pany process must be actively and continually man-

formed by the assigned CFS, and all open issues must

aged to achieve the top-level business objectives. Be-

be addressed and resolved within and across the func-

cause of the dynamics, complexities and opportunities

tions involved.

involved, this is particularly important when it comes

The flowchart is used as a graphic tool to review the

to cross-functional processes.

sequence of events required to accomplish the over-

After the cross-functional process description is

all cross-functional set of objectives. The time taken

agreed on, senior management must formally assign

to reconcile the trade-off decisions facilitates process

ownership responsibility for each process step. The

improvements that provide the leverage of organiza-

individual process owners’ duties are specifically de-

tion wide co-dependencies. When the final version of

fined in the responsibility section of the published pro-

the flowchart is completed, it should be published and

cedure.

distributed for reference for all involved.

During the life of the procedure and the associated

May 2013 • QP 31

process, each assigned process owner is responsible

operations function, and finally the forecast plan was

for actively maintaining and managing the success-

appraised and the results were reported by the finance

ful execution of the process. Anyone requesting any

function. It was clear that a new and improved over-

changes to the officially released process and proce-

all process was required to progress beyond the frag-

dure must first formally obtain the appropriate process

mented approach being used by each of the functions

owner’s approval to do so.

involved.

Final process and procedure

cross-functional performance barrier. Working with

The final document is prepared for senior management

each function, the CFS was charged with defining the

review, approval and release by the CFS. After all the

process-related requirements and responsibilities of

principals and senior management have approved the

each phase of developing the progressive demand fore-

final document, it is added to the organization’s docu-

cast. Because the process had to be managed on a daily

ment control system. The document is managed under

performance basis, it also had to include continuous

formal change control for the life of the process and

performance feedback loops from front to back.

Senior staff was committed to working through the

the procedure.

In the middle of the overall process development

After publication, the process and procedure must

effort, a previously hidden requirement was discov-

be actively monitored by each process owner to ensure

ered. Due to competitive requirements, geographical

they are updated with ongoing business requirements

location product price change requirements had to be

and changes. As business standards change, cross-

continuously accommodated.

functional processes must be managed to reflect the latest competitive performance requirements.

Localized price change introductions affected the product volume quantity and financial contribution of several locations. This required virtually continuous

Example

product price and volume monitoring, and feedback to

A high-tech organization develops and produces prod-

all the functions involved. It also directly impacted the

ucts for the global market, which are delivered through

organization’s overall revenue and profit projections.

a variety of channels. Because of its formula for suc-

Because of the laborious complexities involved,

cess, the organization grew quickly from start-up sta-

the collective process elements took almost a year

tus to being an established and successful multination-

to develop and get buy-in from each function. It was

al competitor.

a massive process development undertaking, but the

As the business grew during its initial years, coor-

mission was accomplished.

dination and communication became increasingly dif-

An integrated, dynamically changing system of pro-

ficult. The rapid growth rate was starting to surface

cesses was developed, and a feedback system that sup-

issues that were cross-functional in nature.

ported each function and its assigned responsibilities

The tasks performed within each function were well defined and, in turn, well performed. Because of

was established. As a result, the organization also was able to improve its forecast accuracy from 50 to 85% .

the scale of the operational entities, however, functional gaps were starting to occur when two or more busi-

Keys to cross-functional success

ness functions were involved. Many of the gaps were

There are several important elements in successfully

not always immediately recognized and, therefore, be-

creating and managing cross-functional procedural

came increasingly difficult to detect and contain with-

processes, including:

out losing operational efficiency.

• Priority alignment. Aligning priorities among the

A series of major cross-functional shortcomings

functional principals into a single priority system

occurred during the monthly worldwide customer de-

is difficult because business priorities vary by sub-

mand forecasting process. The progressive monthly

ject and the time-oriented dynamics of the business

process steps started with the sales function, which

involved. All the participants must share the same

forecast the demand. The marketing function reviewed

level of priority to stay the course and get the tasks

and approved the sales function’s demand forecast.

accomplished in a timely manner. Just getting the

The demand was planned and implemented by the

32 QP • www.qualityprogress.com

initial attention of each of the principals takes time

PROCESS IMPROVEMENT

and involves a fair amount of persuasion. There is

meetings. The CFS must understand the most effective

also the matter of the legitimately different points

way to use systems to bring people together to make

of view that sometimes take several multiparty ex-

effective business decisions. In addition, the design of

changes to resolve.

the workflows developed must remain flexible to take

• Process complexity. By its nature, it is difficult to

advantage of emerging technologies.

explain a diverse set of process steps to someone who is not process oriented. Skill and perseverance

Corporate benefits

are required to break through the roadblock to a

Setting and meeting high-order organizational business

full understanding of the process-oriented require-

goals pivots on understanding what it takes to succeed

ments, which are fundamental to success. Often,

in today’s aggressive and ever-changing competitive

the CFS has to take a “trust me” approach and go

environment. Cross-functional process development

the extra mile to explain the important details in-

provides the platform for successfully managing the

volved to the individual contributors.

co-dependence of the internal corporate organizations.

• Functional bandwidth. To be successful, the CFS

Progressive organizations must take advantage of

must have a diverse set of skills founded in educa-

the considerable amount of knowledge that they have

tion and experience. Although the subject matter

accrued. Business inefficiencies can be difficult to find

may vary by industry, the knowledge and applica-

if you are not specifically looking for them. The devel-

tion of successful management principles and ap-

opment of cross-functional processes provides an op-

proaches are fundamental to success.

portunity to leverage business performance improve-

Most of the internal principals have skills that were

ment opportunities.

developed within their assigned function. The CFS

The first organizations to search for and develop

must have an expanded topical bandwidth of knowl-

cross-functional process improvements will set the

edge to cover the cross section of responsibilities in-

standard for the world-class performance that others

volved while also providing guidance to each principal

will follow. QP

to help him or her achieve a more broadly based understanding of the process. The CFS also must be process literate about proven and emerging systems, particularly when processes are required to span multiple geographies that cannot

H.F. Ken Machado is president of Nonpareil International Inc. in Woodside, CA. He has a bachelor’s degree in industrial engineering from the University of California, Berkeley, and a master’s degree in industrial management from San Jose State University in California. He is a member of ASQ.

rely solely on direct participation in cross-functional

May 2013 • QP 33

emotional intelligence

Mood Righting Increase work engagement through emotional intelligence U.S. ORGANIZATIONS FACE monumental challenges as a global economy has emerged. Arguably, the global economy is driving competitive forces to levels unimaginable only a few decades ago. In response to global economic pressures, many organizations are embracing process improvement initiatives such as lean Six Sigma. Process improvement experts—those tasked with developing and implementing lean Six Sigma initiatives— play a critical role in the process. Research also suggests leadership and teamwork are key elements to success in process improvement initiatives.1, 2

In 50 Words Or Less

• Process improvement efforts often fail because employees and leaders aren’t engaged enough. • A recent study found that those who can manage their emotions are likely to be more engaged in their work, which leads to greater commitment, trust and loyalty. • A more engaged workforce ultimately can lead to improved productivity.

by Scott Thor May 2013 • QP 35

Several authors have suggested that process im-

Belts] must be emotionally intelligent observers and

provement initiatives fail because employees and

practitioners.”10 Other literature suggests that being

leaders are not engaged in the process.

In general,

engaged and having a sense of engagement is impor-

organizations with engaged employees have less ab-

tant for process improvement experts leading lean

senteeism, turnover, theft and accidents, as well as

Six Sigma efforts.

3-5

higher customer satisfaction scores, profitability and productivity.6

This research sought to understand the relationship between emotional intelligence and work engagement

According to Gallup Consulting and Towers Perrin,

of process improvement experts. The primary goal of

fewer than 30% of employees consider themselves to

the research centered on developing a greater under-

be highly engaged, costing organizations billions of

standing of whether organizational leaders tasked with

dollars each year.7-8 Employee engagement research

leading process improvement strategies might be able

conducted by Aurelio Rivera and Jacob Flinck indi-

to tap into individual emotional intelligence, thereby

cates disengaged employees make up nearly 35% of

providing a potential pathway to improving work en-

organizational payrolls, resulting in an annual cost of

gagement, which ultimately leads to more effective

$340 billion.9

process improvement execution.

Author Andrew Milivojevich focused on the personal characteristics of belts working within the

Defining the terms

Six Sigma process when he suggested, “BBs [Black

Peter Salovey and John Mayer coined the term “emotional intelligence,” developing what has evolved into

Emotional intelligence model / figure 1

a four-branch ability model of emotional intelligence, illustrated in Figure 1. The researchers defined emotional intelligence as the ability to accurately perceive, appraise and express emotion; the ability to access and generate feelings when they facilitate thought; emotional knowledge and the ability to understand emo-

Managing emotion

• Controlling emotions. • Keeping an open mind with feelings. • Most difficult of emotional abilities.

tion; and the ability to regulate emotions to promote emotional and intellectual growth.11 Work engagement is a description for the relationship you have with your work. The concept of work engagement has been described as a positive, fulfilling, affective and motivational state of work and related

Understanding emotion

• Distinguishing relationship between emotions and words. • Understanding complex emotions (hate and love).

well-being that is characterized by vigor, dedication and absorption.12 Figure 2 illustrates the concept of work engagement. Vigor refers to individuals’ levels of energy, how willing they are to invest themselves in their work, having resilience and not easily being fatigued, and having

Facilitating thought with emotion

the ability to deal persistently with difficult situations. • Use of emotions to process information. • Ability to use emotions in decision making.

Dedication centers on the notion of meaningful work in which individuals are not only proud of what they do, but are also enthusiastic about pursuing it. A person high in dedication also finds his or her work challenging and inspiring.

Perceiving emotion

• Identifying your own emotions. • Identifying emotions in pictures and faces. • Easiest of emotional abilities.

Absorption is characterized by how immersed an individual is in his or her work. When an individual is absorbed in work, time seems to pass quickly, and everything outside of work is absent from an individual’s thoughts.

36 QP • www.qualityprogress.com

emotional intelligence

Summary of study

Invitations to participate in the survey were emailed

In a recent study, process improvement experts were

to 50,000 U.S. and Canadian ASQ members, and 5,187

invited to participate in the research through their ASQ

members completed the survey. Pearson product-mo-

membership. The study used a quantitative approach

ment correlation analysis was used to determine the

to understanding the relationship between emotional

strength of the relationship between emotional intel-

intelligence and work engagement of process improve-

ligence and work engagement followed by simple re-

ment experts.

gression analysis to infer the predictability emotional

An online survey was used to collect data. The as-

intelligence had to work engagement.

sessing emotions scale was used to measure emotional

The primary research question was, “Does a re-

intelligence, and the Utrecht work engagement scale

lationship exist between a process improvement ex-

was used to measure work engagement. Demographic

pert’s emotional intelligence and work engagement?”

questions also were used to collect participant data for

Four secondary research questions focused on the re-

industry, gender and age (see Tables 1 and 2).

lationship between the four subelements of emotional

Work engagement model / figure 2

Survey participants’ industries / Table 1 Industry

n

Education

140

2.7

Business, secretarial and vocational

36

0.7

Educational services

48

0.9

8

0.2

Elementary/secondary (or K-12) Higher education

Percentage of total

48

0.9

Government

254

4.9

Healthcare

389

7.5

Hospitals

178

3.4

Medical and dental laboratories

72

1.4

Miscellaneous health and allied services

126

2.4

Offices and clinics of doctors of medicine

13

0.3

Manufacturing

2554

49.2

Chemicals and allied products

505

9.7

Electronics

294

5.7

Vigor

Work engagement

Dedication

Absorption

Survey participants’ gender and age / Table 2 Gender/age Female

Percentage

n 2,021

39

19 to 25

23

1.1

26 to 35

304

15

36 to 45

532

26.3

Fabricated metals

354

6.8

Industrial machinery and computer equipment

223

4.3

Measuring and controlling instruments

104

2

46 to 55

788

39

Medical devices

668

12.9

56 to 65

354

17.5

Transportation (automotive, aerospace and rail)

406

7.8

20

1.1

Service

Over 65 Male

3,166

61

1

0.03 1.2

663

12.8

420

8.1

19 to 25

38

18

0.3

26 to 35

308

9.7

104

2

36 to 45

742

23.4

Transportation/logistics services

47

0.9

46 to 55

1,171

37

Wholesale/retail

74

1.4

56 to 65

766

24.2

1,187

22.9

Over 65

140

4.4

Consulting/business services Entertainment/hospitality/recreation Financial/insurance

Other n = 5,187

18 or under

n = 5,187

May 2013 • QP 37

intelligence and work engagement, and the three sub-

work environment that is becoming more common

elements of work engagement.

across the world, resulting in a loss of productivity,

Online Tables 1 and 2, found on this article’s web-

workplace violence, absenteeism and illness.13

page at www.qualityprogress.com, summarize the

The authors suggested emotions used while on the

correlation and regression results of this study, which

job can provide information individuals can tap into,

discovered a positive relationship between emotional

that allows them to alter thinking and behaviors that

intelligence and work engagement, r(5,185) = 0.416, p

result in the ability to better handle organizational

< 0.001. A positive relationship also was found between

challenges more productively.

emotional intelligence and each of the subelements of

Individuals with high emotional intelligence, espe-

work engagement. Regression analysis indicated emo-

cially the ability to manage their emotions, are likely to

tional intelligence predicted 17.3% of the variability in

have the mental strength to stay positive even though

work engagement (R2 = 17.3 %, F(1, 5,185) = 1,086.85,

they face a toxic environment from time to time. This is

p < 0.001).

demonstrated by high levels of vigor in the participants.

This study also discovered a positive relationship

The ability to develop positive emotions and con-

between work engagement and the ability to manage

trol them may provide insight as to why those who can

emotions, r(5185) = 0.475, p < 0.001, which was the

manage their emotions are more engaged in their work.

strongest relationship between the emotional intelli-

Research suggests that when individuals feel positive

gence variables and overall work engagement. Regres-

emotions, they are better able to stay open-minded and

sion analysis indicated the ability to manage emotions

exert greater self-control, allowing them to cope more

predicted 22.6% of the variability in work engagement

effectively in a challenging work environment.14 Re-

(R2 = 22.6 %, F(1, 5,185) = 1,514.32, p < 0.001). To a

search also shows a work environment charged with

lesser degree, the remaining emotional intelligence

positive emotions can lead to greater engagement.15

and work engagement variables also were found to

Author Robert K. Cooper argued that if emotions

have a positive relationship, predicting a smaller per-

are managed, they can lead to greater commitment,

centage of work engagement.

trust and loyalty, which can result in higher productivity by individuals, teams and organizations.16

Research conclusions A number of conclusions can be drawn from this re-

Implications of findings

search, specifically partial answers to the question of

This research has several implications for process im-

what drives engagement in the work of process im-

provement experts tasked with leading quality initia-

provement experts. The results suggest process im-

tives. Successful lean Six Sigma programs have been

provement experts who can control their emotions

shown to rely heavily on employees who are empow-

are likely to find greater engagement in their work and

ered and motivated.17

have the energy to mentally stay involved in their work even when challenges arise.

This research provides a potential pathway to process improvement experts who want to better under-

The connection between managing emotions and

stand what leads to higher levels of work engagement.

work engagement likely goes much further than being

Unfortunately, having a better understanding will only

able to control emotion. Emotions can trigger positive

take them to a higher level of awareness, but will likely

and negative energy, but those who can manage emo-

yield little to no tangible results.

tion tend to have a positive perspective.

To truly harness the findings of this research, pro-

Having the ability to manage emotions comes from

cess improvement experts must work to develop their

overcoming challenges and expecting a good outcome

ability to manage emotions. By doing this, they may be

to arise from even the most difficult of situations. Indi-

able to increase their level of work engagement, and

viduals who can manage their emotions capitalize on

that could lead to greater individual and organizational

their ability to use a positive mood to overcome ob-

results.

stacles that may seem insurmountable.

The challenge then lies in how to improve emotional

Three authors argued emotional intelligence may be

intelligence. Can emotional intelligence be improved?

important for dealing with what they called the “toxic”

The debate has developed since the concept began to

38 QP • www.qualityprogress.com

emotional intelligence

If emotions are managed, they can lead to greater commitment, trust and loyalty, which can result in higher productivity by individuals, teams and organizations. emerge in the late 1990s. Some researchers have ar-

were shown to increase more than 40% and 70%, re-

gued the similarities emotional intelligence has to per-

spectively, in the first two years after training. Boyatzis

sonality implies genetics play a key role in emotional

argued the results are much greater than the typical 2%

intelligence, which would suggest emotional intelli-

increase in social and emotional competencies found

gence might be difficult, if not impossible, to change.18

in traditional MBA students.21

Even geneticists, however, have challenged the

The long-term results also demonstrated the im-

naïve assumption that nurture has no effect on na-

provements can be maintained. Even five to seven

ture.19

years later, participants had maintained more than a 60% improvement in self-awareness and more than a

Intentional change

40% improvement in social awareness over the base-

The work of Richard Boyatzis with MBA students at

line measures.

the Weatherhead School of Management at Case West-

Peter Salovey and David Caruso argued that writing

ern University in Cleveland offers another perspective.

and exercising are two ways of developing the ability

Boyatzis argued there are a set of competencies that

to manage emotions. The authors suggested the act of

all successful managers, professionals and leaders

writing is not what is important. What is important is

possess, including cognitive abilities (IQ), intraperson-

the element within the writing.

al skills such as self-management, and interpersonal

Caruso and Salovey offered several suggestions for

skills focused on relationships with others. The latter

what they called “emotionally healthful writing”:22

two are what Boyatzis described as emotional intelli-

• Using positive words frequently.

gence competencies.

• Using negative words in moderation.

The process of improvement prescribed by Boyatzis is what he described as “intentional change.” Intentional change is “a desired change in an aspect of who you are (that is, your real self) or who you want to be (that is, your ideal self) or both.”20 The model developed by

• Using causal words and phrases such as “led me” or “caused me to.” • Using insightful words and phrases such as “realize” and “understand.” Caruso and Salovey suggested writing to a friend or

Boyatzis consists of five stages of discovery:

using a journal to capture emotions. The authors also

1. Discovering who you want to be: your ideal self.

argued what you write about is not important, stating

2. Discovering who you are, where your ideal self and

“you can write about any event that lets you explore

real self are similar, and identifying the gaps that exist between the two.

your deepest emotions and thoughts.”23 Physical exercise is another way to better manage

3. Establishing a learning agenda to close the gaps.

emotions. Caruso and Salovey said you don’t need to

4. Developing new behaviors, thoughts and feelings

run or ride a bicycle for miles—simply taking a short

that create new neural pathways that lead to mastery.

walk to collect your thoughts may be enough to help

5. Creating trusting relationships that help and encourage each stage.

manage emotions.24 Caruso and Salovey also described a technique

Boyatzis’ work has yielded significant results in

known as systematic desensitization that was devel-

MBA students enrolled in the training coursework.

oped by Joseph Wolpe as a method for staying open

Improvement in self-awareness and social awareness

to emotion.25 The process includes the following steps:

May 2013 • QP 39

emotional intelligence

1. Determine the emotions that cause you the most trouble. 2. Define a list of situations that create this emotion. 3. Rank the situations from the most to least emotionally intense. 4. Learn how to relax in these situations (for example, muscle relaxation techniques, exercise and writing). 5. Create a pleasant and calming mood and relax. Process improvement experts, especially those responsible for developing and executing lean Six Sigma training, also should consider expanding their curricula, which tend to focus solely on the technical skills required for lean Six Sigma (that is, project management, statistics and data collection) to also include the emotional elements that may lead to greater engagement in projects, resulting in improved organizational performance.

Small steps, big impact This research offers a partial answer to the question of what drives work engagement. The research found emotional intelligence predicts a portion of work engagement; more specifically the ability to manage emotions may be the key emotional driver to creating work engagement. While the percentage of work engagement due to emotional intelligence may seem small, consider the size of the problem and what even a minor improvement in work engagement could mean to organizational performance. The results of this research may not provide answers to the entire problem, but even a small portion could make a sizeable financial impact. The sad truth lies in the numbers describing the current state of disengagement with work. Clearly, a problem exists when the vast majority of individuals each day go to jobs for which they have little passion. Not only does the problem create a financial challenge to organizations and the customers they serve, but— maybe even more importantly—the problem leads to

REFERENCES 1. Janet Jacobsen, “Avoiding the Mistakes of the Past: Lessons Learned on What Makes or Breaks Quality Initiatives,” Journal for Quality and Participation, Vol. 31, No. 2, 2008, pp. 4-8. 2. Low Sui Pheng and Mok Sze Hui, “Implementing and Applying Six Sigma in Construction,” Journal of Constructing Engineering and Management, Vol. 130, No. 4, 2004, pp. 482-489. 3. James P. Corrigan, “The Art of TQM,” Quality Progress, July 1995, pp. 61-64. 4. Herbert W. Hoover Jr., “What Went Wrong With U.S. Business’ Attempt to Rescue its Competitiveness?” Quality Progress, July 1995, pp. 83-86. 5. Jacobsen, “Avoiding the Mistakes of the Past: Lessons Learned on What Makes or Breaks Quality Initiatives,” see reference 1. 6. Rodd Wagner and James K. Harter, 12: The Elements of Great Managing, Gallup Press, 2006. 7. Gallup Consulting, “Employee Engagement: What’s Your Employee Engagement Ratio?” 2008, www.gallup.com. 8. Towers Perrin/Towers Watson, “Closing the Engagement Gap: A Road Map for Driving Superior Business Performance,” 2003, www.towerswatson. com. 9. Aurelio Rivera and Jacob Flinck, “Employee-led, Employee Engagement in the Federal Government: SAMHSA Peoplefirst,” Advances in Developing Human Resources, Vol. 13, No. 4, 2011, pp. 479-493. 10. Andrew Milivojevich, “Emotional Intelligence and Six Sigma,” Quality Progress, Vol. 39, No. 8, 2006, p. 45. 11. Peter Salovey and John D. Mayer, “Emotional Intelligence,” Imagination, Cognition and Personality, Vol. 9, No. 3, 1990, pp. 185-211. 12. Arnold B. Bakker, Wilmar B. Schaufeli, Michael P. Leiter and Toon W. Taris, “Work Engagement: An Emerging Concept in Occupational Health and Psychology,” Work and Stress, Vol. 22, No. 3, 2008, p. 187. 13. Moshe Zeidner, Gerald Matthews and Richard D. Roberts, What We Know About Emotional Intelligence: How it Affects Learning, Work, Relationships and Our Mental Health, MIT Press, 2009, p. 302. 14. D. Robinson, A. Rafferty, J. Maben and E. West, “What Makes a Good Employer? The Links Between Effective Human Resource Practice, Staffing Levels, Staff Involvement and Care Outcomes,” The Global Workforce Initiative, International Council of Nursing, March 2005. 15. Izabela Robinson, Human Resource Management in Organizations, Chartered Institute of Personnel and Development, 2006. 16. Robert K. Cooper, “Applying Emotional Intelligence in the Workplace,” Training and Development, Vol. 51, No. 12, 1997, pp. 31-38. 17. Xingxing Zu and Lawrence Fredendall, “Enhancing Six Sigma Implementation Through Human Resource Management,” Quality Management Journal, 2009, Vol. 16, No. 4, pp. 41-54. 18. Robert R. McCrae, “Emotional Intelligence From the Perspective of the Five-Factor Model of Personality,” which appeared in The Handbook of Emotional Intelligence: Theory, Development, Assessment and Application at Home, School and in the Workplace, Reuven Bar-On and James D.A. Parker, eds., Jossey-Bass, 2000, pp. 263-276. 19. Robert J. Emmerling, and Daniel Goleman, “Emotional Intelligence: Issues and Common Misunderstandings,” Emotional Intelligence Consortium, 2003. www.eiconsortium.org. 20. Richard E. Boyatzis, “Developing Emotional Intelligence Competencies,” which appeared in Applying Emotional Intelligence: A Practitioner’s Guide, Joseph Ciarrochi and John D. Mayer, eds., Psychology Press, 2007, pp. 28-52. 21. Richard E. Boyatzis, Scott S. Cowan and David A. Kolb, Innovations in Professional Education: Steps on a Journey to Learning, Jossey-Bass, 1995. 22. David A. Caruso and Peter Salovey, The Emotionally Intelligent Manager: How to Develop and Use the Four Key Emotional Skills of Leadership, Jossey-Bass, 2004, p. 136. 23. Ibid, p. 137. 24. Ibid. 25. Joseph Wolpe, Psychotherapy by Reciprocal Inhibition, Stanford University Press, 1958.

the potential of living a life without meaning. There is little doubt many will find meaning outside of their work, but for most, the time spent on the job far outweighs time spent away from work. The hope is that this research may guide those wanting to tap into their emotional intelligence and provide some help in the development of creating a vigor, dedication and absorption for and in their work. QP

40 QP • www.qualityprogress.com

SCOTT THOR is an associate at Variance Reduction International Inc. in Bakersfield, CA. He earned a doctorate in management from George Fox University in Newberg, OR. An ASQ senior member, Thor is a SixSigma.us-certified Six Sigma Master Black Belt and an ASQ-certified quality engineer, manager of quality/ organizational excellence and Six Sigma Black Belt.

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Innovation Imperative

BY Peter Merrill

Risk and Development Managing risk during new product development I wrote my first Innovation Impera-

In this month’s column, I am going to

Some of the primary areas in which we

tive column for QP in January 2012,1 and

move beyond identifying the nature of the

need data (which, by the way, likely will

my practice has always been to take the

risks we must address and look at how we

not be crisp) are as follows:

issue’s theme and address it from an in-

manage those risks.

1. The time needed to develop a working solution. At this stage, we are only at

novation perspective. The January 2012 issue’s theme was

Fail early

concept.

risk. I discussed how risk enters the in-

My first key point is one you have prob-

novation process. I explained how risk is

ably heard before—fail early. The innova-

internal and external, and how organiza-

tion process has two phases: creative and

tions have become extremely risk averse

execution. The budget for the creative

as we have increased our understanding of

phase is typically only 20% of the total

risk. However, there is evidence that the

cost of getting a new offering to market.

more radical or innovative our new offer-

Clearly, the more we can weed out the

ing, the more profitable the outcome. But,

weak offerings in the creative phase, the

the more radical the offering, the greater

better the outcome.

the risk attached to it. In short, innovation is a risky business.

The creative phase has two steps: 1. Identifying the opportunity. 2. Connecting the concep- tual solution. Focusing on the second step, physicist Linus

duce a working solution. 3. The cost to produce a working solution. 4. How radical is the new solution compared to current solution? 5. How easily can this solution be copied by the competition? 6. Do we have in-house competencies to produce the solution? 7. Who are the new suppliers we will need, and what is the risk attached to those suppliers? 8. What are the delivery chain choices and the attendant risk?

Pauling said the best way

9. What price will the market bear?

to get a good idea is to get

10. The likely return on investment (ROI)

lots of ideas. To gener-

of the new product or service.

ate lots of ideas—and

Those of you who live in the R&D

especially to generate

world will be familiar with the necessary

radical ideas—we must al-

data for developing a new product. Much

low these two steps in the

of this data will have wide tolerances at-

creative phase to operate

tached, but that does not excuse us from

in a loose or free mode.

collecting the data. It can often be helpful

At that stage, in fact, we

to provide support for data collection to

avoid even thinking about

the folks working on the proof of concept

risk.

if data collection is not their strength.

But after we have

42 QP • www.qualityprogress.com

2. The probability of being able to pro-

Another issue to be aware of is the in-

generated our potential

troduction of bias into the data collection.

solutions, we do need to

This can happen so easily and is difficult

address risk. To do that,

to detect. Somebody sees a wild idea and

we need data. Unfortu-

says to themselves: “Oh, I’ll kill that right

nately, creative folks do

away,” meaning, the person will use data

not always enjoy data

to reject the idea. And yet, that wild idea

collection, but it is vital to

may be the perfect solution to the op-

manage risks.

portunity we are addressing. Us engineers

The more we can weed out the weak offerings in the creative phase, the better the outcome.

tend to be good at data collection and analysis, but we are not good at accepting change and are extremely risk averse. We may also have to generate data by modeling or piloting a solution. Software guru George E.P. Box said, “All models are wrong, but some are useful.” Never lose sight of that, but we must still do everything we can to develop data that will

risk. Call it utopia if you will, but that is

strategy of any organization. Without new

guide us in our choice of solutions.

where we aim. This idea can be illustrated

offerings, all businesses will eventually

in a three-dimensional risk tool (Figure 1).

die.

projects. They really were great fun. I

Lead the crowd

ogy-based business, the link is not always

worked on, among others, desalination by

British financier James Goldsmith said,

healthy between the research people

vapor recompression, radical countercur-

“If you see a bandwagon, it’s too late.” In

producing data or proof of concept and

rent liquid-liquid extraction and the early

other words, don’t follow the crowd. It’s

the strategy people making the decisions.

days of carbon fiber.

far more profitable to lead the crowd.

Ironically, the less scientific the organiza-

In my early years as a chemical engi-

Unfortunately, in a science and technol-

neer, I worked on some exciting pilot plant

We have to be careful to ensure these

One of the tools I like for evaluating

tions, often the better the link.

projects do not take on a life of their own.

risk data is a modified version of design

Another factor is organization size.

They are there to generate data. At the

failure mode and effects analysis. There

When I worked in R&D, I was in a major

same time, we must not isolate the people

are a number of other tools and combina-

chemical corporation and the research

running a pilot. They must be connected

tions of tools, but I don’t want to dwell

division was almost an entity of its own.

to the bigger project.

on the use of these tools in evaluating

Connecting to the forward strategy of the

risk levels. I am going to stay focused on

business was a challenge.

After we have the data—and unfortunately it will not all arrive in perfect

With these factors in play, strategic

managing risk.

form—we have to start making decisions.

After we have collected the data, we

decisions often become minor adjust-

The body of data is probably going to be

need to make decisions. It is essential to

ments of last year’s activities instead of

complex, but we must not lose sight of our

narrow focus to manage risk. The deci-

forward-looking strategies with innovative

end goal. We want the most radical new

sions are based on business need and

new offerings.

offering with the best ROI at the lowest

capability, and form the critical forward

The perfect world

/ Figure 1

The job of strategists is to make choic-

Project risk vs. time scale

/ Figure 2

Aim here

High High

High ROI Highly radical Low risk

Try a few of these ideas

Healthy companies also invest here

Medium

ROI High High

Radical

Risk Low

ROI = return on investment

Low

Pressure to invest here 2 years

4 years

6 years

May 2013 • QP 43

Innovation Imperative es and develop the new product portfolio. The portfolio must be a mix of short, medium and long-term projects. The size of the mix will depend on the size of the business. A small to medium-sized enterprise will have probably only two or three selections. However, we should never put all our eggs in one basket and focus on

Businesses must have a longterm strategy looking into the future. This is the ‘seed corn’ for tomorrow’s business.

one new offering—that is far too high a risk. Figure 2 (p. 43) shows how project

tinues to gain knowledge about the new

ing a supplier, but that is often bad strat-

risk relates to project time scale.

offering. As a result, the risk numbers will

egy. There are many ways to mitigate sup-

change and we must manage this.

plier risk, including the use of inventory,

The packaged goods industry invests heavily in short-term offerings, putting

One of the toughest challenges here is

on-site presence and technical support.

more than 30,000 products a year on the

killing an idea that does not pan out but

shelves. More than 70% of those products

that passed the first cut with the strategic

ficult to manage. This is where we start

die within a year. If this is low cost, then

planners. This idea will almost certainly

to give away our secrets. A good strategy

that is a reasonable strategy. But every

be somebody’s “baby” and there will be a

here is to partner in the early days with

business must have a long-term strategy

lot of emotion involved. People will even

a chosen customer or distributor. I used

in which it looks as far as 10 years into

mask new data to keep an idea alive.

this strategy frequently when I ran a

the future. This is the “seed corn” for tomorrow’s business. For example, Xerox found that it had

New data must be thoroughly analyzed

Delivery chain risk is often more dif-

leading brand in the United Kingdom. It

at each design review meeting. Design

is an excellent way of improving speed to

review meetings are notorious for not

market.

to wait an average of 7.5 years for an

clearly recording decisions. The design

acceptable ROI on its best innovations.

review also must be hardwired to the

Risk in innovation

Unfortunately, the pressure for short-term

strategic planning activity. The skills of

Initially, we create many options in the

performance inhibits most companies

the strategic decision maker lie in allow-

creative phase while risk is low. Success

from taking this long-term view. But it’s

ing enough rope in development, but not

depends on collecting good data while

important to only use ROI as a guideline.

too much for people to hang themselves.

still in the creative phase of the new

Think logarithmically: Is revenue going to

It’s also important to remember that this

offering. We then narrow our focus in

be $10,000, $100,000 or $1 million?

refreshment of risk data is not an annual

creating the new product portfolio based

activity. It should be done continuously

on our aim to produce the most radical

The development stage

and should typically be reviewed on a

new offering with the best ROI at the

After decisions have been made and the

quarterly basis.

lowest risk.

the start of managing risk. There is often

External risk

strong link between the subsequent

the false assumption that risk will not

I have focused on risk attached to the

development stage and the strategic deci-

change. But we now leave the research

new offering, but there is another impor-

sion making as risk data becomes more

stage and enter the development stage.

tant area of risk that is often neglected:

precise. QP

Organizations are often structured

external risk. This is split into supplier

To achieve this, we must retain a

portfolio agreed upon, we are still only at

incorrectly by bundling R&D together.

or subcontractor risk and delivery chain

References

Research should partner with marketing;

risk. In my January 2012 column,2 I

development should partner with opera-

quoted data showing that with four new

1. Peter Merrill, “Risky Business,” Quality Progress, January 2012, pp. 50-51. 2. Ibid.

tions. Not many organizations do this,

suppliers, three had a 90% probability of

but for successful innovation you need to

delivering and the fourth had a 40% prob-

give it serious thought.

ability. The overall probability of the new

In the development stage, we take a

offering coming together is only 29%.

concept and develop it into a working

We must evaluate and then manage

solution. The development stage con-

supplier risk. It may even mean purchas-

44 QP • www.qualityprogress.com

Peter Merrill is president of Quest Management Systems, an innovation consultancy based in Burlington, Ontario. Merrill is the author of several ASQ Quality Press books, including Do It Right the Second Time, second edition (2009), and Innovation Generation (2008). He is a member of ASQ and chair of the ASQ Innovation Interest Group.

Quality in the First Person

BY Fitz-George a. Carty

Who’s on Top? Quality can be an uphill battle I’m puzzled by the approaches that

the foreman, so I left it up to the inspec-

his surprise, frustration and dismay—his

many leaders use to engage their employ-

tors to find the damaged parts.

supervisors were angry at him because he gave suggestions to the engineer. Going

ees. Instead of inculcating the pride of workmanship, initiative and openness,

Facing fear

forward, they forbade him to stick his

many leaders encourage a fear-driven

A few years later, while working as a

nose in quality-related matters again.

and reactive work culture by instituting

laboratory shift technician for another

limiting and detrimental work systems

manufacturer, I experienced another

A quality revelation

and policies. Throughout my career, I have

disturbing event. I found that a process

I am sure that most of us have found

witnessed these counterproductive efforts

had continually generated off-target

ourselves in similar situations. Maybe we

again and again.

results—but not during the other techni-

conformed to shoddy work practices be-

cians’ shifts. My persistence in reporting

cause we feared being different or feared

The real world

the off-target results caused my supervisor

ridicule from our peers or supervisor.

My first summer job in college was as

to berate me.

an assembly line worker at a major auto

My eyes were opened and my confi-

After a major customer complained

dence was revived when I discovered

company. On my first day, the supervi-

months later, it was discovered that my

the world of quality management and

sor introduced me to the foreman, who

results were correct and that the other

the teachings of W. Edwards Deming. I

provided me with a 10-minute training

technicians—who feared criticism from

experienced a feeling of redemption when

the supervisor—had

I realized that two of Deming’s 14 points

padded their results.

on quality management reinforced the

Recently, a friend

importance of reducing fear and called

turned to me for advice.

for the elimination of mass inspection

My friend, who is em-

of products. I discovered there are work

ployed by a parts manu-

systems that supported employee involve-

facturer, explained that

ment, initiative and empowerment.

an overseas customer

by supervisors who manage with an iron

ing parts. An engineer

fist. They continue to produce timid and

at my friend’s com-

crisis-driven organizational cultures. As a

pany enlisted his help

result, organizations destroy the commit-

to resolve the problem.

ment of their employees and the pride of

We discussed some ap-

workmanship that maximizes creativity

proaches to find the root

and innovation. The quality professional

cause and implement

must not be discouraged. We must fear-

a solution. My friend

lessly promote the power of quality in

session before I was left on my own to

passed on the suggestions to the engineer.

work. Inexperienced and new, I followed

At the company’s management meeting,

the procedures as carefully as I could.

the engineer presented the ideas and gave

My slower pace attracted the attention

my friend full credit. The plant manager

of my co-workers and the assembly line

ordered that the suggestions be imple-

foreman. They shouted, “Let the bloody

mented immediately. Soon, the number of

parts run, the inspectors will catch them.”

rejected parts fell.

I feared ridicule from my co-workers and

Many organizations are still populated

had rejected incom-

My friend called me afterward to share

transforming the workplace. QP

FITZ-GEORGE A. CARTY is a behavioral and organizational change practitioner in Decatur, GA, and an associate of Interact Performance Systems Ltd. in Anaheim, CA. He holds a master’s degree in management from Antioch University in Seattle. Carty is an associate member of ASQ.

May 2013 • QP 45

Standards Outlook

BY Sandford Liebesman

World View Risk management is a must in today’s global economy the global economy has provided

Risk and analysis

organizations with many opportunities that

Four types of risk worry an organization:

didn’t exist even 10 years ago. On the other

1. Strategic risk is concerned with the

ronmental standards and specifications. 4. Organizational risk is based on the organization’s structure and is found

hand, the internet and extensive outsourc-

inability to achieve high-level goals. To

on two levels—the entity level and the

ing from the United States to countries

assess it, management should consider

activity level. External factors affecting

such as China and Mexico have “flattened”

technology changes, creditors’ de-

organizational risks include technology

the Earth, presenting organizations with

mands, competitors’ actions, economic

developments, competition and new leg-

many new risks.

and political conditions, and customer

islation. Internal factors are information

needs.

system processing, quality of person-

The designers of the Committee of Sponsoring Organizations of the Tread-

2. Operational risk concentrates on fac-

nel hired and changes in management responsibilities.

way Commission (COSO) Internal Con-

tors that prevent the efficient use of

trol—Integrated Framework, the guidance

resources. Factors include the manage-

document commonly used to ensure com-

ment system, customer satisfaction,

analysis method is to determine the risk

pliance to the Sarbanes-Oxley Act (SOX),

the supply chain, revenue recognition,

appetite and risk tolerance. This is neces-

recognized as early as 1992 the importance

natural disasters, information security

sary so all who are part of the organization

of risk management by including it as one

risks and the logistical risks of home-

can understand the risk philosophy. Risk

element of the system of internal control.

land security.

appetite is the amount of risk—on a broad

Now, ISO 9001 developers are including risk in the 2015 revision.

3. Compliance risk affects the ability to

The first step in one particular risk

level—an entity is willing to accept. Risk

conform to legal and regulatory require-

tolerance relates to the amount of risk

There is an assessment process that

ments. These risks focus on financial,

acceptable for each of the entity’s specific

can be used to manage risk to an organiza-

environmental, health and safety, and

objectives.

tion’s objectives. The process consists of

security factors. Government man-

defining the objectives, specifying the risks

dated environmental, health and safety

to determine the risk level and manage

to the objectives and defining methods of

requirements cause concern because of

the risks of concern. One key tool is an

managing the risks. The objectives should

the risk of fines, shutdowns or criminal

organization’s set of financial and quality

be measurable so the effect on them can

prosecution. There is also a concern

controls. A control is a tool that can be

be determined.

about conformance to quality and envi-

used to identify and manage risks. These

After this is decided, there are tools

are especially important for using the COSO guidance to comply with SOX and will be important for certification to the next revision of ISO 9001. Financial controls are set up in accordance with generally accepted accounting principles. They provide reasonable assurance that transactions are recorded as necessary and include accurate maintenance of records. They also may be used to provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition or disposition of assets or other examples of fraud. Quality controls are built around qual-

46 QP • www.qualityprogress.com

ity records and decision points. In ISO 9001, controls appear as “shall” statements. For example, clause 5.6.1 requires top management to “review the organization’s quality management system at planned intervals, to ensure its continuing suitability, adequacy and effectiveness.” SOX compliance includes financial con-

Organizations should start their risk management development with an open discussion of risk and its effect on the organization.

trols at the entity and activity levels. The controls are used in a top-down, risk-based

was originally developed in the 1980s in re-

with sufficient clarity to enable the

approach defined in the Public Company

sponse to the savings and loan scandal. It

identification and assessment of risks

Accounting Oversight Board auditing stan-

is used for internal control over operations

dard AS5 and the Securities and Exchange

and for compliance to external financial

Commission management guidance.

reporting requirements. COSO consists of

achievement of its objectives and ana-

five elements used to manage systems of

lyzes them as a basis for determining

Examples and tools

internal control:

Let’s look at an example of risk manage-

1. Risk assessment: The possibility that

ment at a teaching hospital.1 One of the

an event will occur and adversely affect

major risks at hospitals is patient falls,

the achievement of objectives.

which are a major contributor to the aver-

2. Control environment: The set of

relating to the objectives. • The organization identifies risks to the

how the risks should be managed. • The organization considers the potential for fraud in assessing risks to the achievement of objectives. • The organization identifies and assesses

age length of stay. The Joint Commission,

standards, processes and structures

changes that could significantly impact

which accredits healthcare organizations,

that provide the basis for carrying out

the system of internal control.

has developed tools to help manage risk

internal control across the organization.

Organizations should start their risk management development with an open

and requires use of the tools to maintain

3. Control activities: The actions estab-

accreditation. When the teaching hospital

lished by policies and procedures to

discussion of risk and its effect on the

conducted a risk assessment and estab-

help ensure that management directives

organization. The discussion should cover:

lished quality controls, it found that detailed

to mitigate risks are carried out.

• An overview of the risk management

intervention procedures and additional training in fall prevention were required. As another example of the expansion of the risk management philosophy, all management system standards will now

4. Information and communication: Communication occurs internally and externally, and provides information to carry out internal control activities. 5. Monitoring activities: Ongoing and

method and common tools. • A case study illustrating use of the method. • A preliminary look at the new ISO 9001 risk management requirements.

be required to adopt the structure defined

separate evaluations are used to deter-

It’s also important to understand how

in ISO Guide 83. This will directly affect

mine whether the five components of

the COSO guidance incorporates risk man-

ISO 9001 and ISO 14001, as well as other

internal control—including controls that

agement into an organization, and that the

International Organization for Standard-

affect the principles within each compo-

implementation of risk management must

ization (ISO) standards. In ISO 9001, the

nent—are present and functioning.

be consistent across the organization. QP

The COSO Internal Control—Integrat-

Reference

first three clauses will remain the same as in ISO 9001:2008, but clauses 4 to 10 will

ed Framework has been updated from its

be different. Clause 6 is the one that will

1992 framework in the areas of technology,

include risk management.

globalization, governance and the integra-

ISO 9001 and the COSO internal control

tion of controls with risk. The revised

guidance document are both used to

framework also specifies 17 principles that

comply with the requirements of SOX.

represent the fundamental concepts as-

While they cover different activities in an

sociated with a system of internal control.

organization, both current versions need

The principles associated with risk assess-

updating.

ment are:

COSO is a management system that

• The organization specifies objectives

1. Sandford Liebesman, Competitive Advantage: Linked Management Systems, Paton Professional, 2011.

Sandford Liebesman, president of Sandford Quality Consulting in Morristown, NJ, had more than 30 years of experience in quality at Bell Laboratories, Lucent Technologies and Bellcore (Telcordia). He is an ASQ fellow and past chair of the Electronics and Communications Division. Liebesman also is a member of the U.S. Technical Advisory Group to ISO Technical Committee 176 and the ANSI Z1 Subcommittee on Quality Management.

May 2013 • QP 47

Statistics Roundtable



BY Roger W. Hoerl and Ronald D. Snee

One Size Does Not Fit All Identifying the right improvement methodology THE NEED TO improve is ever present in

install a new computer system. We assign a

The problem is categorized into one

all endeavors and will continue to be so.

project manager to implement the solution.

of four quadrants in the matrix that helps

We live in a dynamic world. As predicted

Knowing the problem solution does not

identify the best solution method. Note that

in the second law of thermodynamic and

mean the solution is easy or unimportant.

the listed methods are illustrative, but not

entropy, the world will continue to change.

For example, a person might know why

exhaustive; other methods could be added.

This change produces a need for improve-

he or she is overweight, and what must be

Let’s look at some examples that illustrate

ment; we have learned that if left alone,

done about it. Keeping weight off is not

how the matrix is used.

things get worse—not better.

easy, however. A key question is, “How?”

Lean Six Sigma is generally considered to be the best available approach to im-

That is, “How to implement solution?” If the solution is unknown, we don’t

Case 1. Last year, we presented a case study in which a company that manufactures flushable baby wipes found that its

provement: true for a lot of problems, but

know why we have this problem. The key

product was clogging septic systems.4

not all problems. In improvement, one size

question is, “Why?” That is, “Why is this

Obviously, this was a serious problem

does not fit all. We have argued a holistic

problem occurring, or what is the root

for the company, but was also clearly a

improvement approach is needed, with the

cause?” Here, a problem-solving approach

special cause: This hadn’t happened in the

four critical building blocks being: leader-

and mindset is needed.

past and occurred suddenly. This sug-

ship, top talent, infrastructure and holistic

Both kinds of problems are impor-

gested that the problem had relatively low

improvement method,1-3, meaning it can

tant to the success of an organization’s

complexity. However, the solution and the

handle any problem.

improvement initiatives. In fact, a blend of

root cause were unknown.

The problem, of course, should define

solution-known and unknown problems

This placed the problem in quadrant

the improvement method. To help get to the

is the rule rather than the exception. The

two. The company chose a team problem-

principal difference is that approaches to

solving approach, using techniques such

discover the best solution are needed in

as brainstorming, Pareto charts and run

solution-unknown problems.

charts. The root causes and appropriate solutions were found using these basic

Problem complexity

tools, resolving the problem and returning

Another critical consideration is the com-

the process to normal.

plexity of the problem. Problems with low

Case 2. One of this column’s authors

complexity are typically isolated prob-

was once asked by an IT professional

lems: problems involving a special cause.

to help him on his Six Sigma project. It

The important question here is, “What

turned out that he wanted to install an

went wrong?” You find the root cause, fix

Oracle relational database to replace a

it and return to normal.

manual system. The author asked him

Problems with high complexity typi-

whether he had done this before, and he

correct characterization of the problem, it

cally involve the entire system and involve

replied yes. So the author asked the IT

is helpful to evaluate two critical variables:

working on common-cause variation:

professional whether he felt he knew how

whether the solution to the problem is

There’s no special cause to fix. Here, an

to do this, and again he said yes.

known and the complexity of the problem.

improvement approach such as lean Six

When presented with a need to im-

Sigma may be appropriate.

Looking at the matrix, this was clearly a solution-known problem. Even though he

prove, the first question we must ask our-

Taken together, these two variables

had done it before, the problem had high

selves is whether we know the solution to

create a matrix (see Figure 1) that is help-

complexity because it could easily be mis-

the problem. Examples of a solution-known

ful in identifying an appropriate problem-

managed with serious consequences. Also,

problem might be to pave the parking lot or

solving method.

the details of how to deploy the database

48 QP • www.qualityprogress.com

The team used an approach similar to

and phase out the manual system were not

project. For example, one team was re-

obvious. It was clearly process improvement

what today would be called lean manu-

sponsible for identifying appropriate data

versus problem solving; the intent was to

facturing. The mill was designed and built

sources as the basis for predictive models.

take the process to a new, higher level of

using these lean manufacturing principles

This task was solution-known, low com-

performance. Therefore, it was a quadrant

and methods.

plexity (quadrant one).

three issue. A reengineering approach was

Case 4. In our book, Six Sigma Be-

used, including lots of mistake proofing and

yond the Factory Floor, we discuss a proj-

but the team knew what was needed

project management rigor.

ect that involved development of a model

(good data covering defaults and non-

It was still important, and nontrivial,

Case 3. The same author also was

to predict corporate loan defaults in the

defaults for more than 20 years), so the

involved in the design and building of a

context of statistical engineering.5 There

solution was known. There was a problem

new, state-of-the-art paper mill, which

was no special cause to fix, and clearly

to be fixed: lack of data. The team knew

involved the application of recent develop-

predicting companies that are likely to de-

the sources to visit to obtain it. They used

ments in manufacturing excellence. This

fault is highly complex. Further, there was

a Nike approach: Just do it. Expertise was

was a solution-known problem because

no known solution, which put this project

needed, but a formal approach wasn't.

the team knew what it wanted to build,

into quadrant four.

Another team had to develop a formal

but figuring out how to build the facility

The team used the Six Sigma ap-

definition of “default” because no gener-

and develop detailed work processes were

proach—specifically, design for Six

ally accepted definition existed; they used

quite complex. Therefore, we view this as

Sigma—to attack the problem. Further,

a WorkOut to do this (quadrant one again),

a quadrant three project.

there were some subprojects to the overall

pulling a team together to discuss this

Methodology options in process ­improvement / figure 1 Solution known

Low complexity

Type of problem

any formal tools. Case 5. Author Thomas McGurk wrote about a major corporate change initiative to improve the supply chain capability

1

2

of a large biopharmaceutical company.6

WorkOut. Nike projects.

Team problem solving* (Problem Kepner-Tregoe. solving— special cause) Why did it happen?

In looking at the details of this initiative,

Who will address it? By when?

High complexity

Solution unknown

problem and work out a solution without

ments of all four quadrants from Figure 1. For example (see Figure 2):

3

4

Lean (kaizen) event reengineering.

Lean Six Sigma, Taguchi methods, TRIZ.

How should we implement the solution?

we believe the overall effort included ele-

What is the solution?

• Conducting bottlenecking analyses of (Process improvement— common cause)

equipment and people (quadrant two). • Improving process yield and reducing batch release time (quadrant four). • Creating new quality specifications for

*Structured team problem solving, using the magnificent seven tools, for example.

critical raw material (quadrant two). • Creating a 50-parameter process moni-

Biopharm process improvement ­problems / figure 2 Solution known

Low complexity

1 • Leadership training for management.

Solution unknown 2 Bottlenecking analysis of equipment and personnel.

• Skills training for process operators. High complexity

3 Create 50-parameter measurement system.

toring measurement system to aid the control of the manufacturing process (quadrant three). • Leadership training for the management team and operating skills training for the process operators (quadrant one). It is not surprising that all four quadrants are used because this problem was a

4 • Improve process yield.

major initiative conducted during a one to

• Reduce batch record release time.

more than 50% for two major products, en-

two-year period. Capacity was increased

May 2013 • QP 49

statistics roundtable suring the blockbuster drug supply would

As noted previously, we feel that the approach should be based on the problem,

satisfy market demand. These applications of the matrix and

not the other way around, and no one

other experiences show that:

method is universally best. We have found

• Many, perhaps most, problems will fall

this matrix works well in guiding practitio-

into one or more, but not all, of these

ners in diagnosing the best approach to a

quadrants. This is natural and to be

given problem, and we recommend it for

expected.

your consideration.

• After we know the quadrant or quad-

Of course, it is not a prescriptive

rants the problem occupies, the possi-

system. It should serve as a guide and not

bilities for identifying the right improve-

dictate the approach to be taken. Further,

ment method are greatly enhanced.

it is not exhaustive; many more methods

• The problem-solving speed and accu-

could be added to the matrix. Use of such tools to guide improvement efforts is an

racy is increased. • Probability of success is increased. Many practitioners have told us over the years that they understand different methods, such as lean Six Sigma, kaizen events, reengineering and WorkOut, but they are confused as to which improvement approach is the best. They also wonder if one method is best for all problems.

example of statistical engineering, a topic we have discussed in detail in earlier Statistics Roundtable columns.7-9 QP REFERENCES 1. Ronald D. Snee and Roger W. Hoerl, Six Sigma Beyond the Factory Floor, FT Prentice-Hall, 2005. 2. Ronald D. Snee and Roger W. Hoerl, “Integrating Lean and Six Sigma: A Holistic Approach,” Six Sigma Forum Magazine, May 2007, pp. 15-21. 3. Ronald D. Snee, “Digging the Holistic Approach—Rethink

Business Improvement to Improve the Bottom Line,” Quality Progress, October 2009, pp. 52-54. 4. Roger W. Hoerl and Ronald D. Snee, Statistical Thinking; Improving Business Performance, second edition, John Wiley and Sons, 2012. 5. Snee, Six Sigma Beyond the Factory Floor, see reference 1 6. Thomas L. McGurk, “Ramping Up and Ensuring Supply Capability for Biopharmaceuticals,” BioPharm International, January 2004, pp. 1-4. 7. Roger W. Hoerl and Ronald D. Snee, “Closing the Gap,” Quality Progress, May 2010, pp. 52-53. 8. Ronald D. Snee and Roger W. Hoerl, “Further Explanation,” Quality Progress, December 2010, pp. 68-72. 9. Ronald D. Snee and Roger W. Hoerl, “Proper Blending,” Quality Progress, June 2011, pp. 46-49. © 2013 Roger W. Hoerl and Ronald D. Snee ROGER W. HOERL is Brate-Peschel assistant professor of statistics at Union College in Schenectady, NY. He has a doctorate in applied statistics from the University of Delaware in Newark. Hoerl is an ASQ fellow, a recipient of the ASQ’s Shewhart Medal and Brumbaugh Award, and an academician in the International Academy for Quality. RONALD D. SNEE is president of Snee Associates LLC in Newark, DE. He has a doctorate in applied and mathematical statistics from Rutgers University in New Brunswick, NJ. Snee has received ASQ’s Shewhart and Grant Medals. He is an ASQ fellow and an academician in the International Academy for Quality.

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3.4 Per Million

BY Joseph D. Conklin

Roundabout Estimation

An indirect way to find quantities you need for your investigation THE IDEAL approach in Six Sigma

nies may exist, and there may not be the

industry trade association that occasion-

is to directly measure your inputs and

money or time to draw one up and visit

ally asks a random sample of them about

outputs. What can a quality practitioner do

most or all companies. Companies may

their cement use. Suppose further that the

when that’s not possible or practical? If the

be unwilling to release internal data to

results are published at the state level. The

difficult-to-measure variable has a known

outside parties if they fear publishing it

companies are more willing to share their

or theoretically reasonable relationship to

might help local competitors figure out

data in this way because:

another quantity that is readily available,

their business.

1. They are confident in the trade associa-

Skipping the measurement may not be

one option is to use this relationship to indi-

an option. In the case of cement use, let’s

rectly estimate the challenging variable.

tion’s ability to protect it. 2. State-level numbers are aggregated at

say this number factors into models of

a high level so competitors can’t figure

tons of cement used in construction for

economic activity used to forecast future

out what any single company is doing

10 counties in a certain state. The direct

business trends in the state. Without it, the

locally.

approach requires drawing up a list of

forecast is incomplete or unavailable. How

construction companies and contractors

might an indirect approach work?

Suppose you want to estimate the total

In this situation, what you want—county level numbers—is unavailable. The trade association has state-level numbers that it

in the state and surveying them about their cement use. This may not be viable for

Building a solution

collects for its own purposes. It’s willing to

several reasons.

To illustrate, suppose the construction

share them to help you meet our goal. How

companies are willing to work with an

do you indirectly estimate the county level

No master list of construction compa-

County data, state totals and indirect estimates of cement tonnage / Table 1 County 1

2

3

4

5

6

7

8

9

10

State total

New permits

1,146

2,004

1,560

6,726

3,501

2,071

7,692

4,549

1,115

2,239

107,168

 Percentage of state total

1.07%

1.87%

1.45%

6.27%

3.27%

1.93%

7.18%

4.24%

1.04%

2.09%

100%

Sidewalk spending 140.90 125.64 146.16 123.72 105.13 188.04 176.16 136.148 176.73 101.38 (thousands $)  Percentage of state total

3.17%

2.82%

3.28%

2.78%

2.36%

4.22%

3.96%

3.07%

3.96%

2.28%

numbers? To keep things simple, say there are two uses that consume almost all of the cement in a state: building and maintaining sidewalks, and new building construction.

4,450.98 100%

Note: State total includes all counties, not just the ten of interest.

With a few exceptions, sidewalk work will be managed by local governments. They will need to keep records

Trade association   Sidewalk tonnage

–

–

–

–

–

–

–

–

–

–

 1,709,979

of how many miles are

  Roofing tonnage

–

–

–

–

–

–

–

–

–

–

21,344,437

covered, or maybe the local budget has a line

County

Estimated cement used

1

2

3

4

5

6

7

8

9

10

Sidewalk tonnage

 18,286  31,976  24,891 107,273  55,862  33,045 122,734  72,584  17,791  34,726

Roofing tonnage

675,678 602,500 700,902 593,293 504,145 901,736 844,766 654,483 846,061 486,162

Note: County 1 has 1.07% of the new permits for the state. Take 1.07% of the state total for sidewalk tonnage. 1.07% of 1,709,979 is the County 1 estimate for sidewalk tonnage. Percents are shown to two decimal places. More precision is used to derive estimated cement used.

54 QP • www.qualityprogress.com

item for dollars spent. New buildings require permits. These are likely on file with the planning or licenses office. While gathering public

Constant relation between variable and tonnage— regardless of level / figure 1

Constant relation between variable and tonnage that ­depends on level / figure 2 60

25

50 40

15 Tonnage

Tonnage

20

10

20

5 0

30

10

1

2

3

4

5

6

7

8

9

10

Spending or permits

0

1

2

3

4

5 6 7 8 Spending or permits

9

10

records involves considerable effort, at

ure 2, which shows tonnage changes at a

a county that local producers and users

least they have a higher chance of being

constant rate over some range of spending

believe are reasonable, considering cur-

accessible than they would with private

or permits. But different rates apply as you

company data.

move from low to medium to high levels of

3. Are there additional variables or special

rent conditions and recent history?

these variables. The true relationship may

adjustments that producers and users

explaining your needs to county govern-

be even more complicated, as shown in

in a particular county can offer to

ments, say you obtain the information

Figure 3 (p. 56): Spending or permits may

improve the quality of that county’s

displayed in Table 1, which provides esti-

have a curved relationship to tonnage.

estimate?

After spending considerable energy

mates of cement use from the more-easily

The only sure way to know is to have

4. Is there a county whose market is so

obtained data using a three-step process:

the actual county level cement tonnage

large that companies in that county

1. Find the total permits and total side-

numbers, but then you wouldn’t need to be

can be confident the local competitors

walk spending for all counties in the

going through the exercise. If indirect es-

cannot figure out their business if they

state.

timation appears to be the best choice for

report their actual use to the trade

getting at hard or otherwise impossible-

association? Can the trade association

to-obtain data, the best way to be sure it is

survey that county alone to produce a

really a good option is to create a checklist

figure for comparison to the indirect

2. Compute the percentage shares of the state totals for the 10 counties. 3. Apply the 10 county shares to the cement data from the trade association.

of tests in advance.

estimate? 5. Is it possible to take some fraction of

What cautions accompany this procedure? First, you need to appreciate the

Concerns about confirmation

the sidewalk or building projects for

important underlying assumption: Cement

In general, the longer the checklist and the

the county, work with the cement users

tonnage has a constant relationship

more tests on it that are confirmed, the

to determine how many tons they used,

with sidewalk spending or total build-

more secure you can feel using indirect

and compare this figure for consistency

ing permits. Figure 1 shows this type of

estimation. The items on the checklist will

against what a corresponding fraction

relationship. In pure form, the relationship

depend on the variable you are trying to

of the county’s indirect estimate would

says any change in spending or permits is

estimate. With respect to the example, here

associated with some constant change for

are some possible tests for a checklist:

any level of tonnage.

1. The relationship that the indirect es-

suggest? 6. This example starts at state-level numbers and estimates down to coun-

timation assumes: Do people with expe-

ties. Can the same indirect estimation

tonnage should move in the same direction

rience in producing and using cement

procedure start with a national number

as either spending or permits. The true re-

think it’s reasonable?

and estimate down to states, assuming

This is a stricter assumption than saying

lationship may be better illustrated in Fig-

2. Does the estimation produce values for

national and all state-tonnage numbers

May 2013 • QP 55

3.4 per million are readily available? Are state-level

data to produce an independent

numbers from the indirect estimation

estimate of the county’s total ce-

consistent with any actual, readily avail-

ment tonnage. If the estimates from this

7. Is there more than one variable that can

independent survey track well

be used for indirect estimates? Do most

with the indirect estimates, as

or all of them produce county level

in Figure 4, you have evidence

estimates that approximately agree?

the indirect estimates are a

The larger truth underlying a checklist

viable option. The opposite

250 200 Tonnage

able state-level numbers?

such as this one is that indirect estimation

Curved relation between ­variable and tonnage / figure 3

situation is shown in Figure 5.

150 100

In Figure 4, an independent

is a form of modeling the data. The ultimate test of a model is how well it reflects the re-

check based on a sample of

ality. Consider Figures 4 and 5 based on the

projects in each county leads

test in option five earlier for how we might

to results that track well with

assess indirect estimation in practice.

the results of the indirect

50 0

1

2

3

4

5

6

7

8

9

10

Spending or permits

Figures 4 and 5 show two ways option

estimation. In this case, you can proceed

can determine whether the procedure has

five on the checklist might work out. Nor-

to any other checklist items you have not

any unforeseen negative consequences for

mally, in the example, the local companies

yet completed.

the quality of its work. Indirect estimation is an instance of a

Figure 5 is a case of results that don’t

are not willing to report their cement tonnages out of confidentiality concerns.

track well. In the Figure 5 case, there’s

useful principle in Six Sigma and quality

Suppose in the first year of indirect esti-

reason to believe the indirect approach

management in general. When the best op-

mates, or every few years afterward, you

needs replacement or adjustment because

tion is not available, make the best use of

are fortunate to find some fraction of the

the pattern of points on the graph shows

the second-best option. Put another way, a

local businesses in select counties willing

large disagreements between the two data

good solution that’s implemented is better

to report their tonnage.

sets.

than a perfect one that’s not. QP

In addition to the steps on the checklist,

Maybe you can get special funding for extra measures to keep this data protected

one more is needed to finish the job. You

that would not normally be available on a

should inform the customer in this story—

regular basis. Whatever fraction of the lo-

the people turning out the state economic

cal business is reported under this special

forecast—about any indirect estimation

data collection, you extrapolate from that

procedure you are using. The customer

1,000 900 800 700 600 500 400 300 200 100 0 0

200

400 600 800 1,000 Indirect estimate (in thousands)

56 QP • www.qualityprogress.com

1,200

Unacceptable comparison with indirect estimate / figure 5 Check against sample of county projects (in thousands)

Check against sample of county projects (in thousands)

Acceptable comparison with indirect estimates / figure 4

JOSEPH D. CONKLIN is a mathematical statistician in Washington, D.C. He earned a master’s degree in statistics from Virginia Tech in Blacksburg, VA and is a senior member of ASQ. Conklin is an ASQ-certified quality manager, quality engineer, quality auditor, reliability engineer and Six Sigma Black Belt.

2,500

2,00

1,500

1,000

500

0 0

200

400 600 800 1,000 Indirect estimate (in thousands)

1,200

Career Corner

BY Rosemarie Christopher

Boost Your Brand Soft skills are vital in today’s workplace In an ERA when many workplaces are

work. You can prepare for certifications

volunteers, you exercise skills such as con-

in flux, it may seem like there is little op-

and take coursework virtually or through

flict resolution, teamwork, collaboration

portunity to build your personal brand and

instructor-led courses.

and negotiation. Furthermore, this experi-

influence organizational culture. I would

While hard skills are certainly impor-

ence offers you a non-threatening learning

argue there’s no better time to do so than

tant, professionals often overlook the

environment (no one can fire you; you’re a

when there is momentum for change

development of soft skills as a continu-

volunteer).

already building around you.

ing education opportunity. Soft skills are

You don’t have to go far to find devel-

increasingly important as roles become

opment opportunities. Even mentoring

is composed of your values, abilities,

more multidisciplinary and job descrip-

others or helping an overloaded col-

strengths and limitations. These denomi-

tions blur. Employers seek a greater

league gives you extra experience that

nators influence how you put your skills

amount of direct collaboration as they

may prepare you for your next career

and experience to work. The most suc-

struggle to do more with less of every-

move—whether it’s at your organization

cessful employees, knowingly or not, align

thing, including human resources. In tak-

or elsewhere.

their personal brands with their organiza-

ing on extra projects or responsibilities,

tions’ cultures.

you may find yourself needing soft skills

change, it’s important to periodically

that have been dormant for years or were

evaluate our work preferences and goals,

never fully developed.

assess how we like to interact with others

Your personal brand is your style. It

Change causes a degree of disruption and chaos in the workplace. When an

As both ourselves and the world

and determine where we are on our per-

organization is in flux, a specific brand is sought after. Employees that brand them-

Opportunities are everywhere

sonal continuous improvement journeys.

selves as change agents, strategists or

Soft skills, developed in good measure,

Periodically evaluating soft skills using

influencers are highly valued. In addition

complement technical mastery. Just as

online assessments is branding at its best.

to being capable of adjusting to change,

there are ways to develop hard skills,

Formally assessing the power of your

the most successful workers also will

there are also ways to strengthen soft

brand confirms to bosses, department

demonstrate a willingness to help manage

skills. The best approach to develop soft

heads and colleagues that among the

or carry out change.

skills depends on individual career goals.

ranks of keepers is a proactive and col-

In my experience, many workers

Verbal communication skills can be

laborative strategist. Employers can only work with what

give the impression that they do not like

strengthened by joining a public speaking

change. An unfortunate truth is that those

and leadership skills-building club, such

employees give them. Organizations real-

who get stuck in ruts will lose out. Organi-

as Toastmasters. Another way would be

ize that there is a huge talent shortage

zations don’t want to push boulders. Some

to step up as a leader of an interest group

that is not going away overnight. They

personalities and generations are better at

relevant to your organization or industry.

are working diligently and strategically to

going with the flow than others. If you’re

When I decided I wanted to improve my

retain top employees and recruit the best.

not wired to embrace change, there are

public speaking ability, I became visible in

Now is the time to take control of your

measures you can take to help you adapt.

organizations that support my industries:

brand and your career. QP

ASQ, the Regulatory Affairs Professional

Soften up

Society based in Rockville, MD, and the

Professionals often enhance their brand

Board of Councilors of the University of

by sharpening their hard skills first. One

Southern California School of Pharmacy

way to update hard skills—technical

in Los Angeles.

and scientific mastery—is to earn new

Participating in an industry-focused

certifications (ASQ alone offers 17) and

group or association is also a way to gain

complete continuing education course-

management skills. By leading groups of

Rosemarie Christopher is president and CEO of MEI RxRS, a search firm for scientific and technical professionals in pharmaceutical, medical device, biologics, diagnostics and biotech companies in Glendale, CA. She has a master’s degree in communication management from the University of Southern California in Los Angeles. Christopher is an ASQ member and the chair of the ASQ Food, Drug and Cosmetic Division.

May 2013 • QP 57

QPToolbox Conductivity sensor

compact

Sensorex’s CS615 conductivity sensor

XF86 series of indus-

monitors process fluids for changes within

trial open-face alter-

critical parameters. The sterilizable sensors

nating current (AC) ta-

are ideal for food, pharmaceutical and

chometer generators.

other contamination-sensitive services

These tachometers are

where sanitary connections are desired.

designed primarily for

The 316 stainless steel construction

758-GF86/

use on shaft ends to

withstands both cleaning in place and

measure speeds of up

steam sterilization processes up to 130°C.

to 100,000 RPMs and

Two sanitary tri-clamp flange sizes are

extremely low torque

available. For compatibility with a number

burdens of less than

of instrumentation models, both sizes

one ounce-inch.

come with optional automatic temperature compensation. Cell constants offered with the CS316

This series of AC tachometer generators are speed transducers in basic form,

efficient performance, while the digital-to-

are 0.01, 0.1 and 1.0, which allow the sen-

consisting of a stator and a permanent

analog convertor function reduces over-

sors a measurement range in most applica-

magnet rotor mounted onto a rotating shaft

shoot problems associated with a conven-

tions from pure water to general industrial

within a customer’s own specified equip-

tional PID controller.

use. The sensors come with a 10-ft. cable

ment. The compact size of the 758-GF86/

with tinned wire terminations for connec-

XF86 series allows them to be installed

features data logging and process data ar-

tion to process monitoring instrumentation.

in inaccessible areas such as gear boxes,

chiving, chart recording, virtual instrument

• Call: 714-895-4344.

diesel engines and conveyor systems.

display and on-screen alarm display.

• Visit: www.sensorex.com.

The units are also impervious to oil, grease and relatively high temperatures.

Tachnometer generators

These meters are modified to reduce

The ATC DigiTec Division has announced the

rapid fluctuation, displaying their output in

The included CALGrafix software

• Call: 800-866-6659. • Visit: www.west-cs.com.

display digits that result from varying speed drive rates. • Call: 304-387-1200. • Visit: www.marshbellofram.com.

Temperature controllers West Control Solutions provides a range of temperature controllers that are designed

Color vision system

for regulating temperature in a variety of

A Cognex has released the In-Sight

applications, including plastics, packaging

7010C, a color vision system that can

and laboratory equipment.

distinguish parts by color. The system

The CAL controllers, which include the

58 QP • www.qualityprogress.com

features 24-bit color resolution that

3300, 9300 and 9400 controllers, offer a

identifies 16 million color variations. In-

menu for programming and full proportion-

dustries using color identification include

al-integral-derivative (PID) operation for

automotive, food and beverage, electron-

ic hardware and pharmaceutical. Along with the In-Sight 7010C, Cognex is introducing three additional color models, the In-Sight 7200C, 7400C and 7402C. These systems solve more complex applications involving logic or color composition, as well as those requiring higher resolution or faster execution. The In-Sight 7000 vision systems also feature a compact housing, factory communications capabilities, autofocus technology and integrated lighting options. • Call: 508-650-3000. • Visit: www.cognex.com.

Photoelectric proximity sensor Sick USA has announced the W27 MultiPac photoelectric proximity sensor. The W27 MultiPac uses two redundant receiver

and beverage industries. The W27 MultiPac provides overhead

bluetooth-enabled smartphones, tablets and computers. The iBlue can replace tools

arrays to detect difficult targets such as

counting and indexing to ensure bundles

such as hardness testers, micrometers and

bundled bottles in the packaging and food

are created and transported properly. It

temperature readers.

offers two independent receiver arrays for

When the iBlue is paired with a Blue-

continuous detection when diffused light

tooth-enabled device, it gathers, records

is misdirected from bundled surfaces. A

and sends data through its three ports: a

single, high-intensity, visible red-emitting

K-type thermocouple port, a three-pin met-

LED aids in alignment and provides detec-

al hardness probe port and a USB human

tion despite dirt and dust buildup.

interface device-enabled port that connects

The W27 MultiPac is able to detect shiny,

with a wide range of non-proprietary tools

glossy or dark targets within its foreground

including keyboards, micrometers, calipers

without signal interruptions. A higher angle

and barcode scanners.

of incidence provides increased mounting

No special software is required and

flexibility, enabling the detection of film-

data from the iBlue can be sent as a text

wrapped pallets and other targets.

email or placed into MS Excel and Notepad.

• Call: 800-325-7425.

iBlue is compatible with the most common

• Visit: www.sickusa.com.

operating systems including Apple’s iOS, Android, Blackberry, Windows and Linux.

Industrial Bluetooth transmitter

• Call: 574-936-2112. • Visit: www.itamco.com/iblue.

Indiana Technology and Manufacturing Companies have released the iBlue, a handheld Bluetooth transmitter that gathers production data and sends it to

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

May 2013 • QP 59

QPReviews Lean Management Principles For Information Technology Gerhard J. Plenart, CRC Press, 2012, 368

or are we creating more problems? • A measurement system is not for management, it is for motivating employees. • People respond to what is inspected,

pp., $79.95 (book).

• Find the root cause. • Standardize to prevent recurrence. Suggestion systems and quality circles are important parts of the house of gemba.

Although this book

not to what is expected.

This is a way to prove that employees are

is intended for IT

Relevant diagrams, illustrations, a

actively involved in kaizen and that man-

practitioners, it is an

serviceable bibliography and index make

agement has been successful in building

excellent resource

this book easy-to-read. The message and

the kaizen infrastructure.

for anyone looking to

materials are simple to assimilate. If you

implement lean man-

are looking to implement or upgrade your

studies from a wide range of organiza-

agement principles.

lean initiative, reading this book is well

tions demonstrating how gemba kai-

The author does

worth your time.

zen has been successfully applied. For

an admirable job of

Marc A. Feldman

providing information

Solvay Chemicals Inc.

on production processes, technology and

Houston

change management, all with the aim of

Included in the book are global case

example, how Caetano Bus in Portugal succeeded in delivering on schedule; how customer expectations were exceeded at Disney World; how Rome’s airport was transformed; how participation made a

larly during the lifetime of an IT project—

Gemba Kaizen: A Commonsense Approach to a Continuous Improvement Strategy

software development, implementation,

Maasaki Imai, McGraw-Hill Professional,

the energy distribution company Enexis

hardware upgrades, user training, quality

2012, 448 pp., $40 (book, second edition).

in the Netherlands; and how quality was

control and piloting—it makes them prime

Gemba means “actual place” in Japanese.

improved at Inoue Hospital in Japan.

eliminating waste. Due to all that occurs and repeats regu-

targets for lean techniques.

Gemba is where

The first portion of the book discusses

difference for Xuji Group in China; how the delivery process was improved at

This is not a book of theory but a book

real action occurs.

of action. Every manager of any type of

the need for IT to become lean. The

In Japanese, kaizen

organization should read this book.

second part covers a structured method

means “continuous

for analyzing and dissecting problems and

improvement.” Kaizen

Luleå University of Technology

processes. The final section provides an

implies improvements

Sweden

overview of continuous process improve-

that involve everyone,

ments.

both managers and

Bengt Klefsjö

Plenart emphasizes that interpretation

relatively little expense. In this second

differ tremendously between practitioners

edition, Imai explains how to reach cost-

Performance-Based Certification: How to Design a Valid, Defensible, Cost-Effective Program

of IT and their customers, internal and

effective improvements by kaizen in a way

Judith Hale, Pfeiffer, 2012, 288 pp., $80

external. Differences occur even within en-

that brings dramatic results through the

(book, second edition).

terprise areas and often are due to varying

power of common sense.

This book shows how to initiate, plan,

In trying to find where lean can benefit,

expectations. Example systems for over-

workers, and entail

Gemba management has five golden

implement and improve a sustainable

coming these disparities are suggested.

rules:

certification program that meets orga-

Simple concepts are offered throughout

• Go to the gemba first.

nizational and stakeholders’ needs and

the book such as:

• Check relevant objects.

expectations. The author notes that the

• What does this process try to achieve?

• Take temporary countermeasures of the

certification program deals with decid-

• Are we working on the correct problem

60 QP • www.qualityprogress.com

spot.

ing which functions will be served and

whether or not the program will deter-

the supply chain and logistics. The author

ment based on this book. The TOC resourc-

mine, screen for and monitor proficiency.

contends that with the addition of TOC

es presented in this book help people who

Also she notes whether the program

to the design and management of supply

work with supply chains understand other

differentiates between levels of capability

chain activities, the user will be able to

aspects of manufacturing where the TOC

or if it even recognizes capability.

make the most of resources and reduce

concepts are applicable.

The book

non-value added activities. It merges two

Roberto Guzman

is organized

subjects critical for every business to en-

Morrisville, NC

based on the

sure market coverage and efficiency.

plan-do-check-

Srinivasan conveys the message with

act continuous

a smooth transition among topics. This is

improvement

a very useful book; however, the author

cycle. The book

stated it was initially intended as a text-

is divided into

book and still could be. But for it to work

Enterprise Performance Management Done Right

as a textbook, it needs practice exercises

Ron Dimon, John Wiley & Sons, 2013, 208 pp.,

10 chapters, each ending with a useful list of errors the author describes as easy-to-

for students to validate

make or frequently made errors. Hale also

what they learn from

provides guidelines to ensure successful

the book.

performance of the steps. In addition,

The individuals who

Recent Releases

$50 (book).

Management: A Concise Introduction

the tools in the form of checklists and

will benefit most from

Richard Pettinger, Palgrave Macmillan, 2012,

guidelines listed in each chapter can be

reading this book will

464 pp., $45 (book).

downloaded free of charge and adapted to

be those in managerial

meet an organization’s unique certification

positions responsible

needs.

for shipping, logistics

experience in the fields of evaluation and

vendor perspective. Supply chain pro-

The Lean Turnaround: How Business Leaders Use Lean Principles to Create Value and Transform Their Company

certification, has created a masterpiece

fessionals should experience improved

Art Byrne, ASQ Quality Press, 2013, 272 pp.,

that provides a set of effective, yet simple

efficiency in resource and people manage-

$35 member, $35 list (book).

The author, through her years of

and receiving activities from a client or

steps, for organizations that plan to launch a new certification program, are searching for solutions to their ailing certification program or are looking for fresh ideas to improve them. Herzl Marouni ABS Consulting Houston

Building Lean Supply Chains With the Theory of Constraints Mandyam M. Srinivasan, McGraw-Hill Professional, 2011, 384 pp., $42.78 (book). This book is based on how theory of

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May 2013 • QP 61

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May 2013 • QP 63

One Good Idea

BY william A. levinson

Act the Fool Heyokas play an important role in an organization’s survival A Heyoka is a sacred clown or contrar-

lenge existing practices without constraint

Shingo asked, “If all you need to do is paint

ian in the Sioux and Lakota language.

by calling attention to underlying assump-

the pen caps, why paint the air as well?”

Using satire and farce, they ask difficult

tions and paradigms. This concept appears

He observed at least half of the paint

questions, help others see situations

in a Diesel clothing company advertising

sprayed missed the caps. That company

differently and open eyes to things often

campaign, “Be Stupid.” The campaign

paid for wasted paint twice: first in the

overlooked.1 Almost every workplace has

encourages people to take risks, innovate

cost of its purchase and again when it

a few heyokas, and they are vital to the

and challenge established paradigms.2

became an environmental problem.

Words of wisdom

doughnut’s hole,” means to pay attention

more than an entertainer or fool. The

Shigeo Shingo often acted as a heyoka. At

to everything that is thrown away (the

jester also played an advisory role. He

a metal forming facility he asked, “Why

hole) as well as the product (the dough-

was the one person who could criticize or

grease scrap metal?” Instead of greasing

nut). Phrases like “grease scrap metal” and

admonish the king and speak the truth and

the entire piece of stock, he thought the

“paint the air” put processes and waste in

The phrase, “keep your eye on the

organization’s survival. In medieval times, a court jester was

3

a new perspective. When Henry Ford said, “Pedestrianism is not a highly paid line [of work],”4 he was commenting on jobs that required workers to walk to get tools and parts due to poor workspace organization. Ford thought walking was a waste of motion that was built into the job and taken for granted. An effective heyoka uses questions and observations to challenge procedures, paradigms and organizational culture—not the people who do the jobs. This is consistent with auditing and other quality approaches that place blame on deficiencies in tasks or the work system, not the staff. QP References

get away with it. The jester’s words could

manufacturer should only grease what

be disregarded as jokes according to social

came into contact with the press. This

norms and customs.

would reduce the amount of lubricant the

The fool in tarot card decks may symbolize a similar role—the ability to chal-

A Lesson from levinson

company needed to purchase. At a fountain pen manufacturing plant,

William A. Levinson is the author of “Easy A,” which features tips to ace certification exams. Check out the open-access column, which appeared in QP’s July 2012 issue, at http://asq.org/quality- progress/2012/07/one-good-idea/easy-a.html.

64 QP • www.qualityprogress.com

1. Wikipedia, http://en.wikipedia.org/wiki/Heyoka. 2. “Be Stupid,” Diesel, www.diesel.com/be-stupid. 3. Shigeo Shingo, (Andrew Dillon, translator), The Sayings of Shigeo Shingo: Key Strategies for Plant Improvement, Productivity Press, 1987. 4. Henry Ford and Samuel Crowther, My Life and Work, Doubleday, Page and Company, 1922.

William A. Levinson is principal consultant at Levinson Productivity Systems P.C. in Wilkes-Barre, PA. He has a master’s degree in engineering from Cornell University in Ithaca, NY, and an MBA from Union College in Schenectady, NY. An ASQ fellow, Levinson is an ASQ-certified quality manager, auditor and engineer, reliability engineer and Six Sigma Black Belt.

What’s Online in the ASQ Knowledge Center? CASE STUDY Quality Strategy Improves Business School Placements Using competitive benchmarking and quality tools, Ramaiah Institute of Management Studies improved job placement results for its students, while also adding a new source of revenue for the organization.

20 2

NEW ISSUES OF QUARTERLY JOURNALS

Quality Management Journal v o l u m e

2 0 ,

i s s u e

2

Perspectives of a Clinical Nurse Specialist About Improving the Quality of Nursing Services Susan Seitz Quality management Journal

A Framework for Leading the Transformation to Performance Excellence Part I: CEO Perspectives on Forces, Facilitators, and Strategic Leadership Systems John R. Latham

An Integrated Framework for Service Quality: SQBOK Perspective Rajesh Kumar Tyagi, Nikhil Varma, and Navneet Vidyarthi

The Journal for Front-line Employee versus Customer Perceptions of Quality Attributes

Quality and Participation

Anne Julien and Christina Tsoni

People | Pride | Performance January 2013 | www.asq.org/pub/jqp Vol. 35, No. 4

2013

Leadership Issues and Approaches in the 21st Century www.asq.org

WEBcast Leadership Balance Results and Relationships

Delivering Process Excellence Through Process Management

Quality Culture Kaizen

Performance Metrics Psychological Effects

Business process management (BPM) can be seen as the maturation of process excellence— the perfect blend of quality program, project, and process. In this webcast provided by the Six Sigma Forum, learn what BPM is, how it links to your existing continuous improvement strategy, and how to deploy it successfully.

You can find all the latest issues of ASQ’s quarterly journals in the Knowledge Center. In addition to browsing the full table of contents for each issue, read sample articles available open access. April saw new issues from Quality Management Journal, Journal for Quality and Participation, Journal of Quality Technology, and Quality Engineering. Look for Six Sigma Forum Magazine and Technometrics in May.

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

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