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Putting Best Practices to Work

QUALITY PROGRESS

www.qualityprogress.com | January 2014

QUALITY PROGRESS | JANUARY 2014

Breaking Down
Shifting your mindset to embrace the big data movement p. 16

TECHNOLOGY

Barriers
Plus:
Strategies to release your creative spirit p. 30 3-D printing springs to life p. 50

VOLUME 47/NUMBER 1

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TL 9001

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Contents
Putting Best Practices to Work | January 2014 | www.qualityprogress.com

FEATURES
16 24
TECHNOLOGY

Breaking Down Barriers


by Shu Liu

16

To survive in the big data world, quality professionals must change their mindset, get more data, upgrade their skills and expand their roles.

Follow the Fundamentals

Before diving into that next big data project, get reacquainted with four data analysis basics to ensure a successful outcome.

by Ronald D. Snee, Richard D. DeVeaux and Roger W. Hoerl

30 38

INNOVATION

Fresh Perspective

Unlock your creative potential and actively pursue the quality ideal by leveraging innovation, technology and quality.

by Nicole M. Radziwill and Tracy Owens

CASE STUDY

Back in Service

Learn how a team at a Georgia military base retooled the way it repaired and maintained the U.S. Air Forces C-130 Hercules to keep the giant transport aircraft ying.

ONLY @

www.qualityprogress.com

by Satya S. Chakravorty

Learn More From Liu

38

Author Audio features Shu Liu discussing more about big data and the quality professionals role in it, the subject of this months cover story, Breaking Down Barriers (pp. 16-22).

Daily Dose of News Talk Back

Check Quality News Today for the latest quality-related headlines. Rate and comment on this months four feature articles.

Free Advice

Check out QPs archive of the Expert Answers department.

DEPARTMENTS
6 8 12
LogOn
Missing master journeymen. Quotes feed mind and soul.

Expert Answers

Selecting, developing KPIs. Controlling multiple processes.

QP
Mail

QUALITY PROGRESS

The advancement of EQMS software. 2013 ASQ fellows named.

Keeping Current

14 58 60

Mr. Pareto Head QP Toolbox QP Reviews

46

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Quality in the First Person


The value of giving back.

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

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48 50 53 56 64

Career Corner

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Task management tips for the digitally unhip.

Innovation Imperative
The power of 3-D printing.

Statistics Roundtable
The accuracy of analytical equipment.

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EXECUTIVE EDITOR AND ASSOCIATE PUBLISHER
Seiche Sanders Mark Edmund

QUALITY PROGRESS

Tech Savvy
Technologys inuence on daily existence
THIS MONTH, QP tackles the topic of technologyan unwieldy endeavor indeed. Technology is changing everything, every day. From how heavily people rely on their smartphones for their day-to-day work and socialization, to the implications of big datapersonally and professionallytechnology continues to affect our lives more deeply now than ever before. And so there are countless angles that could be taken, but I think this months contributors did a pretty good job. Our cover story, Breaking Down Barriers, p. 16, looks at the topic of big data from a quality perspective. Shu Liu describes what big data are and how big data approaches might change qualitys role: In the big data world, the experience of quality professionals will lose some of its value and much of the traditional job functions as a quality guard will be performed by computers. Quality professionals must venture into the spaces that big data cant predict: to dream, to think outside of the box, to adventure and to invent, he wrote. Liu offers advice on shifting mindsets in order to navigate the new frontier. With the right skills, quality professionals can ourish in the new age. Fresh Perspective, p. 30, delves in to the links among technology, innovation and quality. We can all benet from a little kickstart to creativity, and the stories relayed in this article can provide that inspiration. A high schooler who developed an affordable brain-controlled prosthetic limb using 3-D printing? Amazing! And thats just one of the stories the authors discuss. 3-D printing is covered in more detail in the Innovation Imperative column, The New Revolution, p. 50. Peter Merrill describes the benets and threats related to this fascinating technologyan innovation that will undoubtedly change the way work gets done, what materials cost, how supply chains function and much more. The day where 3-D printing is mainstream is fast approaching. How will it affect what you do? QP

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To promote discussion of issues in the eld of quality and ensure coverage of all responsible points of view, Quality Progress publishes articles representing conicting 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.

January 2014 QP

LOGON
Seen&Heard
The good ol days
As I was reading the Keeping Current article No Bachelors Degree Required (September 2013, pp. 12-13), what immediately came to mind is that back in the good ol days, we had tradesman and master journeymen who possessed the lions share of the science, technology, engineering and math skills without having a university degree. These master journeymen also took on apprentices whom they tutored and to whom they passed on their knowledge and experience. But many big corporations decided to do away with these master journeymen positions to save money. Thats why you now have degree-holding graduates in the eld who do not know which end of a screwdriver to hold. Alex Lau Whitby, Ontario Good quotes are always food for the mind and soul. It simply reminds us that we are here for something good, and we must do it good, with quality and value. Buds M. Fernando Philippines

Tune In

Give credit where its due


I couldnt agree more with the servant leadership concepts presented in At Your Service (November 2013, pp. 3843). I try to practice it when challenged with leading a group in problem solving. It is my goal to make all participants open minded to all ideas and to make those contributors feel like their ideas are worth considering. The one thing I nd most important is at the conclusion of the problem-solving project, recognize everyone involved (to them and bosses) for their contributions. A sure way to kill future team input is to take credit alonefor the teams success. Dont for once think the teams members arent aware of it. Tom Herr Huntingdon Valley, PA

The latest ASQ episode focuses on careers in quality. In the episode, get career development tips, learn how to get the most out of mentoring and find out where the quality jobs are. Also, watch upcoming episodes on risk management (available Jan. 7) and global supply chains (Jan. 28). Visit http://videos. asq.org to access the full video library.

Resonating words
In response to Words to Work By (November 2013, pp. 18-25): Love the quotes. I would also add: Quality without data is just cheerleading, to which I usually comment that I am not a cheerleader. Not that cheerleading cannot get results. I had an instructor who said, If you want to improve quality and yields in a steel mill, paint a red band on a visible structure, such as a smoke stack. Everyone will be on their best behavior, assuming they are being watched and a temporary improvement will happen. This, of course, is not sustainable. Real and continual improvement requires understanding how to make changes that eliminate negative variation and waste. Mike Williams Carol Stream, IL

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

Executive Editor & Associate


Publisher Seiche Sanders: @ASQ_Seiche Associate Editor Mark Edmund: @ASQ_Mark Assistant Editor Amanda Hankel: @ASQ_Amanda Contributing Editor Megan Schmidt: @ASQ_Megan editor@asq.org www.facebook.com/ groups/43461176682

Quality tweets
@lupaulise: New on ASQ TV: Why ISO 9001, one of the worlds best known standards, is being revised. Plus, a guide to auditing. http://videos.asq. org/home. @jstepnio: Excited to see the December issue of Quality Progress arrive today! Dont miss my Quality in 1st Person article! :) pic.twitter.com/ vgRM6Ojprh. @knowwareman: World Quality Month went by so fast! #WQM13 #qimacros.

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PAST CHAIR CHAIR
John C. Timmerman, Gallup Inc.

QUALITY PROGRESS

www.qualityprogress.com

Big data details


Hear more about what quality professionals must know about big data in this months Author Audio interview, featuring a conversation with Shu Liu, author of Breaking Down Barriers, (pp. 16-22).

Stephen K. Hacker, Transformation Systems International LLC

What do you think?


Let us know what you think of the articles in this issue. Sound off by emailing
editor@asq.org, or go online to rate and comment on this months feature articles.

CHAIR-ELECT TREASURER

Cecilia Kimberlin, Kimberlin LLC (retired Abbott) Chava Scher, RAFAEL Advanced Defense Systems (retired)

Quality questions?
Submit a quality-related question using the online Expert Answers form or email it to
editor@asq.org, and QPs subject matter experts will help you nd a solution.

PARLIAMENTARIAN
Karla Riesinger, ASQ

DIRECTORS

QUICK POLL RESULTS


Each month at www.qualityprogress.com, visitors can take an informal survey. Here are the numbers from last months Quick Poll: What do you like best about your job? Its challenging. 64.7% Lots of career growth opportunities. 14% I dont like my job. 12.6% The amount of money I make. 8.4% Visit www.qualityprogress.com for the latest question: What developing innovation will have the biggest impact on our world? Big data. 3-D printing. Package-delivering drones. Self-driving cars.

Heather L. Crawford, Apollo Endosurgery Raymond R. Crawford, Parsons Brinckerhoff Ha C. Dao, Emerson Climate Technologies Inc. Julia K. Gabaldn, Quality New Mexico Gary N. Gehring, Saskatchewan Ministry of Government Relations David B. Levy, Tekni-Plex Flexibles Division Sylvester (Bud) M. Newton Jr., Alcoa Daniella A. Picciotti, Bechtel Steven J. Schuelka, SJS Consulting Kush K. Shah, General Motors James B. Shore, Nipro Healthcare Daniel E. Sniezek, Lockheed Martin (retired) Joal Teitelbaum, Joal Teitelbaum Escritrio de Engenharia Alejandra Vicenttin, Vicenttin Organizational Excellence & Kaizen G. Geoffrey Vining, Virginia Tech, Department of Statistics Bharat Wakhlu, Tata Services Ltd., Division of Tata Sons

QP EDITORIAL REVIEW BOARD


Randy Brull, chair

Administrative Committee

QualityNewsTODAY
(All URLs case sensitive)

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

Recent headlines from ASQs global news service


Hondas New Plant Takes Manufacturing to Next Level The factory, with annual capacity to make 250,000 vehicles, specializes in small cars based on the Fit platform. It bustles with hyperefcient machinery that shaves cost and time from Hondas already lean manufacturing process. (http://bit.ly/newhondaplant) Retailer Amazon Announces Drone Delivery Plan Jeff Bezos, Amazon.coms chief executive, says he is planning to take something that looks like a barbecue grill, attach eight propellers and a basket to it, and use it to deliver small items to peoples houses. (http://bit.ly/amazondronedelivery)

Technical reviewers

Andy Barnett, Matthew Barsalou, 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, Imran Ahmad Rana, John Richards, James Rooney, Brian Scullin, Amitava Sengupta, Mohit Sharma, A.V. Srinivas, Joe Tunner, Manu Vora, Keith Wagoner, Jack Westfall, Doron Zilbershtein

WANT THE LATEST QUALITY-RELATED NEWS AND ANALYSIS? The QNT Weekly enewsletter delivers it every Friday. Subscribe now at http://email.asq.org/subscribe/qntwk.

January 2014 QP

EXPERTANSWE
Selecting and developing KPIs
Q: How should process improvement teams select and develop key performance indicators (KPI) to measure performance in the short and long term? A: I would begin by understanding the objectives of the process improvement team. Usually, the process improvement objectives are derived from the broader organizational strategic objectives. Examples may include improving the market share in specic product segments or geographical locations by a certain percentage, increasing the number of differentiated innovative products or reducing the operation expenses by a certain percentage. After you understand which of the strategic objectives the process improvement team maps to, you can determine appropriate KPIs for the process. For example, for a process improvement team mapping to the objective of reducing operation expenses by X%, KPIs may include items such as rst pass yield, throughput, number of engineering changes post production release, equipment uptime, training hours per employee and per process, and lost hours from accidents and safety incidents. An improvement team from a service function mapping to an organizational objective may have different KPIs than a team working in the manufacturing environment. Examples of service KPIs may include transaction duration, transactions on time and transaction error defects per million opportunities. It is difcult to exactly identify appropriate KPIs until you know the larger organizational objectives your process relates to. Also, note in this response I am not distinguishing between measures and indicators. For an indicator, measurement relates to performance and is not a direct measure.1 There are some guidelines for selecting indicators. One item to consider is lag, which refers to how far the measure is removed from real-time performance of a process, and how soon you may react to it. Indicators with short lag (the measure is not far removed from real-time performance of a process and you may be able to react quickly) are preferred for the team directly managing the improvement. Author Richard J. Schonberger suggests you should react often to short lag-time metrics, less often to those with intermediate lag and seldom for metrics with long lag time. Contrarily, business scorecards tend to display metrics intermixed as to lag times, and managers tend to react to them, with goals and corrective assignments, at a xed time interval, typically monthly.2 Schonberger suggests using three levels of indicators: 1. Indicators with short lag times for the direct team management. 2. Indicators with monthly or quarterly lag times for middle management. 3. Indicators tracked on an annual basis for senior management.3 The indicator should get broader as it gets to the third level. For example, percentage of nonconformances may be a rst-level measure for a performance improvement team; cost of poor quality may be a secondlevel measure for middle management; and operation expenses may be a third-level measure for senior management. Second level or third-level measures cannot exist by themselves without supporting rst-level
REFERENCES
1. National Institute of Standards and Technology, 2013-2014 Baldrige Criteria for Performance Excellence, Measures and Indicators, p. 47. 2. Richard J. Schonberger, Time-Relevant Metrics in an Era of Continuous Process Improvement: The Balanced Scorecard Revisited, Quality Management Journal, July 2013, pp. 10-18, http://bit.ly/qmjmetrics. 3. Ibid. 4. Duke Okes, Performance Metrics: The Levers for Process Management, ASQ Quality Press, 2013, pp. 29-40. 5. Jack Zigon, Measuring the Hard Stuff: Teams and Other Hardto-Measure Work, 1998, http://asq.org/forums/teamwork/ proceedings/2000/Proceed/00025.html (case sensitive).

metrics the performance team can act on. To reinforce this idea, author Duke Okes recommends that the measures be deployed down and across the organization: Having a high-level metric that does not have supporting metrics existing in the right processes will not add value other than letting management know that things arent going well.4 In his article, Measuring the Hard Stuff: Teams and Other Hard-to-Measure Work,5 Jack Zigon provides a structured approach to developing performance measurement: 1. Review the organizational measures. 2. Dene measurement starting points. 3. Weight the results (based on relative importance). 4. Develop performance measures. 5. Develop performance standards. 6. Decide how to track the performance. In general, do not select measures and indicators that are irrelevant to the improvement objective. This will waste the teams time in driving actions that have no impact. Also, ensure that the measures are not redundant, such as measuring yield and internal failure costs. If the internal failure cost has more failure components, break down the details into separate measures. Ensure the data are from a reliable source and are veried periodically for integrity. Govind Ramu Director, quality assurance SunPower Corp., San Jose, CA

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RS
Usually, the process improvement objectives are derived from broader organizational strategic objectives.
Controlling multiple processes
Q: Is rational subgrouping in statistical process control (SPC) (determination of subgroup sample size and sampling frequency) done by experience and knowledge about the process, or by using proven statistical methods? Whats the best approach? Is it acceptable to plot one SPC chart representing multiple manufacturing lines for the same process parameter? A: By nature, manufacturing processes are subject to inherent random variation due to common causes. Attempts to reduce process variation when no assignable causes of variation are present by making adjustments that are supposed to remove the random variation only adds an additional source of variation and increases it. Reduction of the random variation due to common causes only can be achieved by process improvement. Therefore, the purpose of process control is maintaining it in the state of statistical control by detecting and removing assignable charts to causes. This is achieved using x detect process shifts and R charts to detect and occurrences of increased variation. The x R values are calculated from samples that form rational subgroups, usually of product units that have been manufactured at practically the same time to remove the effects of the variation from the assignable causes and increase the ability of the control charts to detect occurrences of the special causes. Determining sample size of rational sub chart is relatively straightgroups for the x forward. Using statistical methods, you can falling calculate the probabilities of the x between the control limits as a function of the process shift for several sample sizes and graph those values as operating charac chart.1 Reduction of teristic curves of the x the rates of false alarms and of the delayed detection of occurrences of assignable causes also are achieved by using various rules for interpreting patterns of the data points in the control charts. For example, observing a run above or below the target of a length exceeding a critical value signals a process shift that must be investigated and xed before the noncomplying product could be manufactured. The process shifts can be detected faster if you take larger samples more frequently, but this is not economical. More frequent and smaller samples can reduce the losses due to delays in detection of process shifts while producing noncomplying product. Statistical methods of economical design of the control charts that include optimizing the control limits, sample size and frequency of sampling have been proposed.2 Designed control charts minimize total cost of quality. With economical automation of sensing and process monitoring, ultimately every unit of product can be inspected as it is produced, leading to the fastest detection of occurrences of the assignable causes. The latter approach, though, is applicable only to nondestructive testing.
REFERENCES
1. Douglas C. Montgomery, Statistical Quality Control, second edition, Wiley, 1991, pp. 111-113, 226-229. 2. Ibid, pp. 413-447.

When the process consists of multiple manufacturing lines, charting each stream (machine, machine head and workstation) separately allows for faster identication of assignable causes occurring in any manufacturing line. Because monitoring multiple manufacturing streams separately was quite difcult when control charts were made and reviewed manually, various approaches were used to reduce the number of control charts. For example, a single chart was often used when charting the maximum process shifts among all streams. When the maximum process shift or maximum variation was within the respective control limits, no action was needed. Only when an assignable cause was detected was the effort taken to identify the stream where it occurred. This made process control more manageable. With modern computerized control charting, however, monitoring each process stream separately has become more feasible with large numbers of the streams. An example is charting process streams at a textile plant that manufactures multiple kinds of yarn, uses multiple spinning machines for each type of yarn, and each machine has hundreds of heads. Jeffrey E. Vaks Roche Molecular Diagnostics Pleasanton, CA

January 2014 QP

QUALITY COUNCIL OF INDIANA


CQIA PRIMER CSSBB PRIMER CQE PRIMER CQT PRIMER CSQE PRIMER CBA PRIMER CRE PRIMER CMQ PRIMER CQI PRIMER CCT PRIMER CQA PRIMER CSSGB PRIMER CQPA PRIMER
C C C C C C C C C C C C C

PRIMERS
New CBA

Our Primers contain study material for the current ASQ bodies of knowledge plus sample questions and answers. The Primers may be taken into the exam. The completeness of our materials makes them the most widely used texts for Certification Training.

Quality Council of Indiana offers detailed solutions to all questions presented in the corresponding Primer.

SOLUTION TEXTS

QCI offers user-friendly interactive software to assist students preparing for ASQ examinations. Each CD contains 1000 total questions. Examinations are timed and summarized graphically. A help file provides explanations and references. The CDs run on Windows XP and newer.

CD-ROMS

CQE CSSGB

CQA

Mail Orders Quality Council of Indiana Order Department 602 W. Paris Ave. W. Terre Haute, IN 47885-1124

Information 812-533-4215

Internet Orders www.qualitycouncil.com

Telephone Orders 800-660-4215

Fax Orders 812-533-4216

Jurans Quality Handbook


by Juran & De Feo The essential quality reference for most ASQ exams
En Espaol

Implementing Six Sigma


by Forrest W. Breyfogle, III A great CSSBB reference

The Quality Technicians Handbook


by Gary K. Griffith Great for CQT and CQI exams.

CSSGB PRIMER

Spanish Green Belt


The Spanish version of the CSSGB Primer.

Quality Dictionary
by Tracy Omdahl More than 2500 definitions. Great for any ASQ certification.

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

RAM Dictionary
by Tracy Omdahl Contains 2800 definitions. Helpful for Reliability and Quality Engineers.

ISO 9001 Internal Auditing Primer


by Greg Wies & Bert Scali A convenient book for training internal auditors to the ISO 9001 expectations. An instructor CD is available.
ISO

ISO Primer
by Bensley & Wortman Presents a thorough treatment of the ISO implementation and documentation process. There are generic manuals on the CD.

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

Quality System Handbook


by Edenborough
QSH

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

KEEPINGCURRE
Disjointed and Disconnected
TECHNOLOGY

M
much on their plates.
Reduce the total cost of quality. Improve customer experience. Reduce nonconformances in manufacturing. Better manage operational risks. Ensure compliance. 0%

Research shows more organizations turning to enterprise quality management software to deal with quality issues
Manufacturing and industrial executives face more challenges related to product and process quality than ever before. In todays global marketplace, manufacturing operations are becoming more complex as facilities and suppliers expand in number and geographical location. Add in the dynamics of consumer preferences and regulations, and business leaders have In addition, its common for quality management strategies and IT capabilities to vary considerably between facilities and regions, with solutions to many challenges implemented as needed. Rather than acting as an enabler of stronger quality management, disjointed systems and data sources often hinder executives ability to address these new enterprise challenges. To keep pace with these challenges, more business leaders are adoptingor planning to adoptenterprise quality management software (EQMS), an emerging software category that allows organizations to globally standardize, streamline and centralize key quality processes. According to new research by LNS Research, a Cambridge, MA-based technology research rm focused on the industrial space, the software takes a more modern, holistic approach to overcoming quality challenges and can consolidate many of the traditionally manual and isolated processes that surface as roadblocks to improvement. More than 500 executives from a wide range of industries and organization sizes participated in the LNS Research 2012-2013 Quality Management Survey, which highlights quality executives objectives and challenges, and illustrates the need for a more comprehensive solution for managing quality.1 and improve customer experience. The survey also asked quality executives what their biggest quality challenges were in 2012. Participants were not limited to just one response. The primary challenge surrounding quality was effectively measuring quality metrics, with more than 55% of executives identifying this as a main concern (see Online Figure 1 at this articles webpage at www.qualityprogress.com). Interestingly, the top challenge aligns with quality executives top objective of measuring cost of quality. For the second-most prevalent response, more than 50% of quality executives said their organizations cultural approach to quality was a challenge because quality was viewed as an individual department, not a shared responsibility across the enterprise. The challenges of handling disparate quality systems and data sources were the thirdhighest response, with about 45% citing this. The top challenges are symptoms of having disconnected quality systems and data sources across the enterprise, and they are best overcome by consolidating and integrating IT efforts across the value chain. Without this integration, it is typically too expensive and resource-intensive to get a holistic picture of the cost of quality and effective quality metrics. EQMS can help organizations bridge the gap between disparate quality systems and data sources and enhance the ability to effectively measure quality metrics.

Objectives, pain points


Early in the survey, executives were asked to rank their top quality management objective. The top executive goal was to reduce the total cost of quality; 37% of executives chose this as a top priority across industries (see Figure 1). Given the level of detail into the effectiveness of quality processes the cost of quality metric can provide, perhaps its not surprising that reducing it was ranked as the top quality management objective for most decision makers. The second and third-most important objectives for quality executives were to reduce nonconformances 25% 30% 35% in manufacturing

Top quality management objectives / FIGURE 1

Taking on challenges
EQMS software can help organizations achieve this big-picture visibility with a platform approach that supports crossfunctional communication and collaboration

5%

10%

15%

20%

12 QP www.qualityprogress.com

NT
on various quality issues. The solution automates traditionally manual processes such as compliance management, audit management and supplier quality management, allowing standardized instances of those processes to be deployed across the enterprise. Organizations typically choose to globally standardize with EQMS only those processes that deliver substantial synergies at the enterprise level. For this reason, methods for deploying EQMS tend to be unique to each organization. LNS Research has seen consistency in some of the highest implementation rates, however, with functionalities such as corrective and preventive actions (CAPA) and document management. Because CAPA is so widely used, it generally makes sense to deploy it across the enterprise with EQMS. Delivering CAPA with EQMS drastically reduces enterprise risk, and similar benets are being experienced with other EQMS functionalities as well. As more quality executives see the potential return on investment from standardizing quality processes that benet their organizations on a single platform, EQMS implementations are expected to rise, which the survey data also shows. The survey asked quality executives about adoption rates of EQMS, as well as those of more commonly implemented enterprise solutions such as enterprise resource planning (ERP) and business intelligence (BI) for perspective. Though only about 20% said they had currently implemented EQMS software functionalities, 27% said they were in the planning stages of an EQMS implementation (see Online Figure 2). Contrast this with ERP and BI, which both had higher current adoption rates at about 75% and 40%, respectively, but also had a lower percentage of survey respondents in the planning stages. About 15% of survey respondents replied that an ERP implementation was in the planning stages, and about 18% were in the planning stages for BI. These data are indicative of potential growth of the EQMS space in the near future, and of the
(continues on p. 14)

Whos Who in
NAME: Hemant P. Urdhwareshe. RESIDENCE: Pune, India, which is located near Mumbai.

EDUCATION: Bachelors degree in mechanical engineering from Visvesvaraya National Institute of Technology in Nagpur, India; business management diploma from the Institute of Management Development and Research in Pune. FIRST JOB RELATED TO QUALITY: Urdhwareshes job as process engineer at Cummins India Limited (CIL) was his introduction to quality. Later, he became quality leader and management representative at CIL and had the opportunity to implement Cummins total quality system. CURRENT JOB: Principal consultant and trainer at the Institute of Quality and Reliability, his consulting rm. PREVIOUS JOB: Head of quality, engineering and reliability functions at CIL from 1977-2005. ASQ ACTIVITIES: Chair of local community council in Pune. Recently, Urdhwareshe worked for ASQ India training and preparing about 100 design engineers for the ASQ Certied Reliability Engineer exam.

OTHER ACTIVITIES/ACHIEVEMENTS: Along with his team of consultants, Urdhwareshe has worked with Indian industry to implement Six Sigma and reliability improvement initiatives. He also has trained and motivated many professionals to improve their quality skills and seek ASQ certication. His rm has trained more than 1,000 Six Sigma Black and Green Belts and about 2,400 professionals in various quality certications and skills. For the last ve years, Urdhwareshe has served as a panelist for the Six Sigma Excellence Awards, instituted by Symbiosis Institute of Management and Human Resource Development. He also has been a visiting faculty member at the Symbiosis Institute of Business Management, teaching business statistics and Six Sigma. PUBLISHED WORKS: Author of Six Sigma for Business Excellence (Pearson Education, 2010) and co-author of Total Quality Management (Pearson Education, 2011). Also authored many articles on Six Sigma, quality and Indian cricket. RECENT HONOR: Urdhwareshe was included in the 2013 class of ASQ fellows. He also received the Qimpro Foundation Silver Standard Award 2003, which is given to an outstanding quality manager in India. PERSONAL: He and his wife Rashmi have one son, Sarang, who works for Cummins Turbo Technologies in Pune. FAVORITE WAYS TO RELAX: Playing the accordion and other keyboard musical instruments, uploading many of his songs on YouTube and playing chess with friends. QUALITY QUOTE: Quality is a result of attitude, knowledge and execution. Apply the knowledge and convert it into solutions and success.

January 2014 QP 13

KEEPINGCURRENT
Surge in software? (continued from p. 13)
value quality executives and technology decision makers are seeing in its functionality. BALDRIGE

NEW DIRECTOR NAMED


Robert Fangmeyer, previous deputy director of the Baldrige Performance Excellence Program (BPEP) at the National Institute of Standards and Technology (NIST), was named the programs new director late last year. Fangmeyer will be the third director to lead the BPEP since Congress established the program in 1987. Fangmeyer has been served as acting director since his predecessor, Harry Hertz, retired in June 2013. Prior to the BPEP, Fangmeyer worked for six years as a HR specialist in NISTs ofce of workforce management. For more information, visit www.nist.gov/baldrige/baldrige-director-112013.cfm.

EQMS and operational metrics


Users of EQMS applications reported measurable improvements in several operational metrics, such as overall equipment effectiveness (OEE), a holistic business measurement that includes quality, efciency and asset availability. According to the survey, respondents who implemented EQMS software experienced a median OEE that was 8.5% higher than that of organizations without EQMS functionality. Respondents with EQMS capabilities also reported a 3% higher on-time delivery rate median, a 3% higher products in compliance median and a successful new product introduction median of 24% more than those that lacked capabilities. The data show integrating disparate systems and leveraging centralized and automated workow capabilities with an EQMS allows organizations to streamline processes and better react to any quality issues that arise. Compared to the past, the complexities of todays competitive environment can no longer be supported by a disjointed quality IT architecture. As technological capabilities advance and the world becomes even more interconnected, issues around quality will be subject to growing supply chains and heavier scrutiny. The need for EQMS is growing, and the 27% of respondents who noted an implementation on the horizon are positioning their organizations for a competitive advantage in quality.
REFERENCE
1. Matthew Littleeld and Mike Roberts, The Global State of EQMS, LNS Research, Sept. 10, 2013, www.lnsresearch.com/research-library/research-articles/the-global-state-ofeqms-ebook-. MATTHEW LITTLEFIELD is president and principal analyst at LNS Research in Cambridge, MA. He holds a masters degree in industrial engineering and operations research from the University of Massachusetts in Amherst.

QUALITY RESEARCH

THIRD GLOBAL STATE OF QUALITY REPORT RELEASED


The third installment of three separate reports contained within the rst-ever ASQ Global State of Quality Research has been released. Insights and Continuing Conversations features feedback about the research from stakeholders and offers possible opportunities for future iterations of the Global State of Quality Research. The latest report follows the high-level Discoveries 2013 report and the Analysis, Trends and Opportunities 2013 report that offer comparative data based on organization location, sector and size. ASQ, which teamed with the American Productivity and Quality Center to conduct the research, also is publishing four short, topicspecic Spotlight Reports. To access the reports, visit http://asq.org/global-state-of-quality/ index.aspx.

Mr. Pareto Head

BY MIKE CROSSEN

14 QP www.qualityprogress.com

ANSI UNVEILS NEW STANDARDS PORTAL WEBSITE


The American National Standards Institute (ANSI) recently launched a website for anyone to access standards that have been incorporated by reference in the U.S. Code of Federal Regulations (CFR). The Incorporated by Reference (IBR) Portal (http://ibr.ansi.org) allows visitors to see the standards incorporated into federal laws and regulations. The select standards are offered at no cost in read-only PDF format for online review. They cannot be printed or downloaded. In recent years, issues related to IBR have gotten more attention, particularly in connection with requirements that standards incorporated into federal rulemakings be reasonably available to the U.S. citizens and residents affected by these rules. This requirement had led some to call for the invalidation of copyrights for IBR standards. Others have posted copyrighted standards online without the permission of the organizations that developed them, triggering legal action from standards developing organizations (SDO). Standards now available on the ANSI IBR Portal include those developed by the International Organization for Standardization, the International Electrotechnical Commission and seven other SDOs that have signed a terms and conditions agreement with ANSI. All users must install a plug-in and accept an online end user license agreement before accessing any of the standards. In addition to the standards available directly through the portal, several SDOs are offering free access via their own websites. Links to those websites can be found at the IBR Portal.

STANDARDS

2013 ASQ FELLOWS CLASS ANNOUNCED


The ASQ Board of Directors has named 24 ASQ fellows. The 2013 class includes: Randy G. Aschbrenner. Thomas Berestene. Bryan T. Blunt. William A. Brenneman. Belinda Chavez. Javed Cheema. Scott Clary. Trevor A. Craney. Elizabeth A. Cudney. David S. Foxx. Edwin Garro. Christopher L. Grachanen. Douglas Hlavacek. Jerry Mairani. Mark A. Morris. Peter Pylipow. Christine Marie Robinson (named posthumously). Gideon I. Roth. Rajesh Sharma. James R. Simpson. Anshuman Tiwari. Kwok-Leung Tsui. Hemant P. Urdhwareshe. Ver-Non T. Wakeeld.

AWARDS

SHORTRUNS

ASQ WAS RECENTLY awarded a new contract to continue its administration of the Malcolm Baldrige National Quality Award. ASQ has been the sole administrator since the awards inception in 1987. The latest contract began in October and lasts one year. A REVAMPED TheSRO.org website has been unveiled. The new site centralizes social responsibility (SR) resources with more focus on storytelling and helps visitors navigate the content easily and quickly. New case studies on the site also illustrate the correlation between quality and SR on a personal, organizational and community level. For more information, visit www.thesro.org. THE BALDRIGE PERFORMANCE Excellence Program is seeking applicants for the Malcolm Baldrige National Quality Award Board of Examiners for the 2014 award cycle. Applications are due Jan. 9. Visit www.nist.gov/baldrige/examiners/ index.cfm for more information. APPLICATIONS FOR THE 2014-2015 Ellis R. Ott Scholarship are now available

through ASQs Statistics Division. The $7,500 scholarshipsnamed for one of pioneers in the use of graphical methods for applied statistical analysisare for students in masters degree or higher programs with a concentration in applied statistics or quality management. For more information and an application form, visit http://asq.org/statistics/about/ awards-statistics.html. Applications are due April 1. PAUL PALMES has been named the international chair of the International Organization of Standardizations (ISO) Technical Committee 176 Subcommittee 1, which covers quality management and quality assurance concepts and terminology. The subcommittee is responsible for the development of ISO 9000, which is currently under revision and expected to be published in 2015, along with ISO 9001. Palmes, a senior member of ASQ, is principal consultant and owner of Business Systems Architects Inc.

January 2014 QP 15

Breaking Down
What quality professionals need to know to survive and thrive in the age of big data
In 50 Words Or Less

Barriers
by Shu Liu THREE DECADES AGO, Joseph M. Juran
coined the term big Q to capture a fundamental change that was occurring in the eld of quality management. He labeled the narrow focus on product quality little q and called the new practice big Q because it focused on improvement of all organizational processes. Big Q has drastically broadened the quality umbrella and fundamentally
Big data are fundamentally transforming our lives; with the data come powerful change, and also risks, to our society. To leverage the benets and prepare for the challenges, quality professionals must change their mindset, get more data, upgrade their skills and expand their roles in the big data universe.

TECHNOLOGY

improved the effectiveness of quality management practices and philosophies.1, 2 Today, the world is experiencing another transformation from small to big: from small data to big data. The nature of big data presents positive and negative impacts to our society, and quality professionals must learn how to survive and succeed in the big data world.

January 2014 QP 17

What are big data?


Big data are a collection of data sets that are too big and too complex to be processed using traditional database and data processing tools.3 The characteristics of these giants can be summarized by three Vs:4, 5 1. Volume. The amount of data stored in the world is growing exponentially. It reached 1.2 zettabytes (one zettabyte equals 1021 bytes) in 2013 and will be at an estimated volume of eight zettabytes by 2015. Yes, that is the number eight followed by 21 zeros. At the same time, the cost of data storage is dropping in the same patternfrom about $1 million per gigabyte (one gigabyte equals to 10 bytes) in the 1980s to 10 cents per gigabyte by
9

again and again for different purposes (the secondary use) after the rst use (the primary use).9

The dark side of big data


Big data, if not managed properly, may pose a great threat to privacy, human volition and democracy. The recent debate on the National Security Agencys surveillance program is not going to end anytime soon, and it fuels a broader discussion on how to protect the privacy of ordinary citizens in the big data era.10 Not only do big data increase the risks to privacy, but they also change the character of the risks. Because big data are available for secondary use, the effectiveness of the traditional ways of protecting privacyindividual notice and consent, opting out and anonymityhave been largely lost.11 A growing number of parole boards in the United States are using the predictions from big data analysis as factors in making decisions on granting inmates parole. More cities are using predictive analytics to select locations and individuals that should be subject to extra scrutiny. It would be dangerous if the decisions on punishment or scrutiny were based mainly on the probability of crimes that have not been committed. The fundamental problems of such a system could go far beyond the law enforcement eld, including everything from employers ring employees, banks denying mortgage applications or a wife divorcing her husband, just because of a high probability of a bad act that has yet to happen.12 If the output of big data analysis is allowed to rule by placing unmerited faith in predictive analytics, democracy as we know it could be in danger.

2010. 2. Velocity. The increasing rate at which data travel has followed a trend similar to that of volume growth. Data are generated, collected, stored and processed with increasing speed to meet the demand for data. 3. Variety. The sources of big data are everywhere. Databases, documents, emails, phone records, meters, sensors, images, audio and video les, and nancial transactions are examples of sources. Increasingly, the actions you take, the words you speak or type, the websites you visit, the locations where you stay and the people you meet are recorded and stored somewhere.6

The power of big data


Even at the dawn of their era, big data have already exed their huge muscles on every aspect of our lives, accelerating economic growth, scientic progress and international development. In the big data world, far more data can be processed, and in some cases, all the data relating to a particular phenomenon can be analyzed. Furthermore, big data allow a look into subcategories in a way traditional sampling analysis can never achieve. At the center of big data is predictionapplying math to huge data sets to infer probabilities. Big data analysis is playing an ever-increasing role in decision making in private and public sectors. Table 1 lists some application examples of big data analysis, just to show the tip of the iceberg.7, 8 Big data now are raw business materials that create a new form of economic value. In fact, big data have become a fountain of value because data are reused

Change your mindset


So, what do big data mean to quality professionals? Are you ready to meet the challenges of this transformation that is fundamentally changing the way you live and work? You must change the way you think about sample size, exactitude and causality. The rst mindset change is to move from some to all. In the small data world, youre forced to settle for small data sets because it is impossible to collect and analyze all data. To make the sample statistics represent the whole population, you collect sample data as randomly as possible. Achieving total randomness, however, is difcult,

18 QP www.qualityprogress.com

TECHNOLOGY

if not impossible, and random sampling does not scale easily to break results into subgroups. Random sampling also risks missing some important information that does not appear frequently. Bias may slip into the sampling process, for example, in answering questionnaires. In the big data world, you can collect much more data or even all data (N = all). Using all data makes it possible to nd connections and to explore details and subgroups. Big data give you freedom to check many hypotheses and to examine data closely from different angles. Big data also reduce bias associated with sampling because data are collected quietly when people are conducting their day-to-day activities.13 The second mindset change is to relax exactitude for probability. In the small data world, clarity and certainty are often demanded as much as possible. Entering the world of big data, you neednt worry about individual data points biasing the overall analysis because you can rely on a large amount of data to make predictions. In fact, by relaxing exactitude, you are able to collect more data that will improve the accuracy of the prediction outcomes and help get a more complete sense of reality. Yes, big data are messy as long as the tools used to collect and analyze information are imperfect, but obsession with exactitude in the big data era is often counterproductive because it wastes resources and hinders the effort of collecting and analyzing more data. Instead of treating inexactitude as a problem, consider it a part of the reality.14 The third mindset change is to loosen up causality for correlation. In the small data world, choices of proxies for correlation analysis are often based on some hypotheses, and their accuracy is examined by correlation analysis. This is a slow and expensive process that is often clouded with prejudice and intuition. Investigating real causality based on small data sets is often not practical and frequently serves as a shortcut to conrm existing knowledge and beliefs. In the big data age, vast data are available, and powerful computing power can quickly identify the optimal proxies. Correlation analysis based on big data provides probability, not certainty, and tells us what, not why. In many cases, this fast and cheap noncausal analysis is good enough, and it aids causality study as it provides likely causes up front.15

Application examples of big data analysis / TABLE 1


Application Mortgage value estimation Vehicle breakdown prediction Mechanized identication for special events Health risk identication without medical testing Correct diagnosis identication Customer retention Targeted marketing Predictive advertisement targeting Movie and book recommendations Employee retention Guided studying for targeted learning Pregnancy prediction Description Predict which mortgage holders will prepay within the next 90 days, and decide whether to sell the mortgages to other banks. Predict which parts of the shipping vehicles will break down, and perform preventive maintenance. Predict which items customers will buy during a special event, and stock them at the front of stores. Predict which applicants have high risks of certain illnesses, and calculate their insurance premiums. Predict risks of premature babies, and make correct diagnostic decisions. Predict which customers will leave, and do something to retain them. Predict which customers will be persuaded to buy, and contact them. Predict which advertisement each customer is most likely to click on, and display the best one. Predict what rating a customer would give to a movie or a book, and make recommendations to the customer. Predict which employees will quit, and do something to retain good ones. Predict which questions a student will get wrong, and recommend more study time. Predict which female customers will have a baby in coming months, and make relevant offers to them. Predict the locations of future crimes, and patrol these areas. Predict which inmates will offend again, and decide whether they should be paroled. Predict which transactions or applications are fraudulent, and audit them. Predict which low-level internet communications originate from imposters, and block such interactions. Predict which emails are spam, and divert them to a spam email folder. Predict correct answers to win the Jeopardy! quiz competition by IBMs supercomputer Watson. Predict which blog entries express anxiety, and calculate an aggregate measure of mass mood. Predict which voters will be persuaded, and contact them.

Crime prediction Recidivism prediction for law enforcement Fraud detection Network intrusion detection Spam ltering Open question answering Blog entry anxiety detection Political campaigning with voter persuasion

Get more data


Data are becoming the new oil that fuel economic engines. One day, the value of data will appear on

January 2014 QP 19

corporate balance sheets as a new asset class. Those on the big data value chainthe data holders, data specialists and institutions with a big data mindsetwill benet from big data, but ultimately, most value lies in the data themselves. This is because data always speak theres always something to learn. Value can always be extracted from datas primary and secondary uses. In a world that data-es everything, organizations that master big data have a chance to outperform their competitors and widen their leads. Small but nimble players can enjoy scale without mass, while mid-sized data holders will be under great pressure to ght for their survival.16 Quality professionals must help their organizations get more data and aid decision making with big data analysis, as demonstrated by the examples in Table 1.

You can gain more internal data by automating and data-fying business processes. Big data should be used not just to generate reports, but also to distill patterns for predictive analytics. By carrying out data mining on public databases owned by governments, the outcomes of predictive analytics can be used not only for governmental purposes, but also for a nongovernmental organizations benet. Organizations can buy data from private data holders, and share and merge data with other data holders through intermediaries.17 Under some business arrangements, all contributors to the merged data sets can extract value from them. Finally, organizations can exploit more value from data sets by reusing them for different purposes, by combining different data sets into a new one, by de-

Sample decision tree model

/ FIGURE 1

Interest rate < 7.94% Yes Income < $78,223 Yes 2.6% Yes No Interest rate < 7.19% No 9.1% Yes 8.1% Yes Property is a condo, not a co-op Yes No Loan/value ratio < 87.4% Yes Mortgage < $67,751 No Interest rate < 8.69% No 25.6% No 6.4% Yes No Mortgage < $182,926 No Property is a condo, not a co-op Yes 15.2% No 40%

3.4%

8.5%

16.3%

The percentages in the circles represent the risks of prepayment by individual mortgage holders. The path highlighted in blue illustrates the predictive analytics on Mary Bowsers risk of prepayment. Source: Eric Siegel, Predictive Analytics: The Power to Predict Who Will Click, Buy or Die, Wiley, 2013.

20 QP www.qualityprogress.com

TECHNOLOGY

signing extensibility into big data sets for multiple uses and by harvesting data exhaustthe data shed as a byproduct of peoples actions and movements.18 Data can, if necessary, be sold to data buyers, and an organization can charge fees to those who use its data.

$100,000 and a loan/value ratio of 80%. The path of the predictive analytics on her case is highlighted in blue in Figure 1. Other predictive modeling tools that can be used include articial neural networks, loglinear regression, support vector machines and TreeNet.24 If you want to learn predictive modeling, read some online information and books or take a free online course.25-28 Quality professionals must learn how to work cohesively with big data scientiststhe specialists in data analysis, articial intelligence and statistics. Their skill sets are complementary to those of quality professionals, and they bring something new to the game: They usually have developed a professional habit of letting the data speak without prejudgment and prejudice. You also can keep current on government policies and regulations aimed at protecting the society from the risks of big data and at preventing the creation of data barons. Victor Mayer-Schnberger and Kenneth Cukier, authors of Big Data: A Revolution That Will Transform How We Live, Work and Think, envision the following developments in government policies and regulations on big data: Hold data users accountable for what they do. Implement differential privacy to blur some data sets so a data query will get only approximate results. Guarantee human agency so signicant decisions made by government and organizations that affect people will be based on peoples behaviors and actions, not simply on the predictions from big data analysis. Build a new profession called algorithmist (or another suitable name) to take on the tasks of monitoring and auditing accountability, traceability and fair competition.29

Upgrade skills
In the small data world, people base decisions on a combination of facts, reections and educated guesses. The latent knowledge accumulated throughout life experiences plays a critical role in the traditional decision-making process. This is going to change in the big data world, where decisions are made, or at least conrmed, by big data analysis. Quality professionals must learn the skills associated with big data, such as statistics, rudimentary predictive modeling and basic computer programming, to leverage it in the decision-making process. For statistics, tools for correlation and regression are most important to grasp.19-21 The Pearson productmoment coefcient is the most common correlation method that measures the linear relationship between two variables, while the Spearmans rank correlation coefcient is a nonparametric measure of statistical dependence between two variables. In the regression area, least square is a commonly used method, and nonlinear, orthogonal and logistic regressions are other regression procedures. In terms of predictive modeling, a decision tree is a method you may want to learn rst because it is most popular among big data scientists due to its balance of simplicity with effectiveness. It is not nearly as complex as you might think. Figure 1 is the decision tree chart used by Chase Bank to predict the risk of prepayment by individual mortgage holders.22, 23 It is basically a ow chart-type structure with rectangles representing a test on an attribute, and each branch coming out of that test representing an outcome of the test. Each branch leads to a new test until it reaches a decision (in this case, the decision is the risk of prepayment). To predict the risk of prepayment of a mortgage holder, each case tumbles down the tree from top to bottom, going through a series of tests until it reaches its destination. For example, the model predicts that Mary Bowser, a mortgage holder, has a 25.6% propensity to prepay her mortgage. The prediction is based on her data: an interest rate of 8.8%, a mortgage of

Explore hinterland
In the big data world, the experience of quality professionals will lose some of its value, and much of the traditional job functions as a quality guard will be performed by computers. Quality professionals must venture into the spaces that big data cant predict: to dream, to think outside of the box, to adventure and to invent. They must become the right-brainers who are capable of supplementing their technical skills with abilities that are high concept (design, story and symphony) and high touch (empathy, play and meaning).30

January 2014 QP 21

TECHNOLOGY

Design is about discovering patterns and opportunities and creating beauty. A person with story ability knows how to craft convincing narratives. Symphony is an analogy referring to combining different ideas into something new. Empathy is about identifying with and understanding other peoples emotions and feelings. Play means that you nd joy in your life and elicit delight in others. Meaning refers to a pursuit of pur-

pose and meaning.31 Sailing into uncharted waters with a new mindset, powerful data sets and upgraded skills, quality professionals will meet the challenges of big data with condence and ourish in this new age. This is an important aspect of big quality in the 21st century. QP
REFERENCES AND NOTES
1. B. Solomon, Its All About Big Q, The Big Q Blog, Juran Institute, Jan. 21, 2011, www.juran.com/blog/?p=188. 2. Russell T. Westcott, The Certied Manager of Quality/Organi- zational Excellence Handbook, third edition, ASQ Quality Press, 2005. 3. Wikipedia, Big Data, http://en.wikipedia.org/wiki/big_data. 4. Gartner, Gartner Says Solving Big Data Challenge Involves More Than Just Managing Volumes of Data, Jan. 27, 2011, www.gartner.com/newsroom/id/1731916. 5. Big Data Now: 2012 Edition, OReilly Media Inc., 2012. 6. Ibid. 0) 7. Eric Siegel, Predictive Analytics: The Power to Predict Who Will Click, Buy or Die, Wiley, 2013. 8. Victor Mayer-Schnberger and Kenneth Cukier, Big Data: A Revolution That Will Transform How We Live, Work and Think, Eamon Dolan/Houghton Mifin Harcourt, 2013. 9. Ibid. 10. For details about the U.S. National Security Agencys (NSA) surveillance program, see Bryan Walsh, The NSAs Big Data Problem, Time, June 2013, pp. 23-25. 11. Mayer-Schnberger, Big Data, see reference 8. 12. Ibid. 13. Ibid. 14. Ibid. 15. Ibid. 16. Ibid. 17. Ibid. 18. Ibid. 19. T.M. Kubiak, The Certied Six Sigma Master Black Belt, ASQ Quality Press, 2012. 20. Robert S. Witte and John S. Witte, Statistics, ninth edition, Wiley, 2009. 21. Minitab 16 software, regression and correlation sections. 22. Siegel, Predictive Analytics, see reference 7. 23. Ali Moazami and Shaolin Li, Mortgage Business Transformation Program Using CART-based Joint Risk Modeling, Salford Systems Data Mining Conference, 2005, vvvhttp://docs.salford-systems.com/MoazamiLi.pdf (case sensitive). 24. Siegel, Predictive Analytics, see reference 7. 25. Robert Nisbit, John Elder and Gary Miner, Handbook of Statistical Analysis and Data Mining Applications, Academic Press, 2009. 26. Tom M. Mitchell, Machine Learning: Science/Engineering/ Math, McGraw-Hill, 1997. 27. Saed Sayad, An Introduction to Data Mining, http://www. saedsayad.com. 28. Stanford University offers a free online course at www. coursera.org/course/ml. 29. Mayer-Schnberger, Big Data, see reference 8. 30. Daniel H. Pink, A Whole New Mind: Why Right-Brainers Will Rule the Future, Riverhead Trade, 2006. 31. Ibid.

ISO 9000 & QMS


(International Conference on ISO 900

22nd Annual World Conference on

T H E W O R L D S L A R G E S T G AT H E R I N G O N

I S O 9 0 0 0 & Q M S S TA N D A R D S

ISO 9000
2015 REVISION
H OT E L I N F O R M AT I O N CO N F E R E N C E R E G I S T R AT I O N
Conference registration fee starts at $995 for individuals and $945 for government and groups with the QP2014 registration code. Registration will start on Oct. 1, 2013.

Dont wait until the last minute! Take the lead and get ahead of your competition on complying with the revision. Many industry-specific QMS Standards are based on ISO 9001 and when the ISO 9001:2015 is published, related industry-specific standards are likely to change. You need to be aware of the impact on your business. Come and learn how your industry will be affected.

The group rate is $180 for single or double occupancy with the group code ISOLSS. Tel: +1 (800) 937-8461 for reservation. Designated hotel for government attendees is Sheraton Four Points.

CO N F E R E N C E CO N TAC T
Tel: +1 (412) 782-3383 +1 (888) 236-9940 Email: info@iso9000conference.com www.iso9000conference.com

SHU LIU is the senior R&D manager at SunEdison Semiconductor in St. Louis. He earned a doctorate in chemistry from Virginia Polytechnic Institute and State University in Blacksburg, and an MBA from Robert Morris University in Pittsburgh. An ASQ senior member, Liu is an ASQ-certied manager of quality/ organizational excellence and Six Sigma Black Belt. Liu is also a certied Six Sigma Master Black Belt from Arizona State University and a certied Lean Master from Lean Enterprise Inc.

22 Ad_edits.indd QP www.qualityprogress.com ISO ASQ 1

9/15/13 1:42:20 PM

2014 WORLD CONFERENCE ON QUALITY AND IMPROVEMENT


THE GLOBAL IMPACT OF QUALITY May 5 7, 2014 | Dallas, TX | wcqi.asq.org

The 2014 World Conference on Quality and Improvement offers attendeesno matter their industry or level of quality knowledgea forum of ideas and an international network of thought leaders, experts, and peers eager to share best practices, tested solutions, and proven results.

Discover how quality can IMPACT your organization, career, and life.
 Learn from more than 80 concurrent sessions centered on the 2014 theme and focus areas.  Dive deeper into quality with 12 hands-on workshops.  Apply quality tools in your personal life with After 5 Sessions. Learn from expert keynote and featured speakers.  Meet other people passionate about quality with multiple networking opportunities.  Get best practices from companies successfully using quality with the International Team Excellence Award/ Quality Impact Sessions.

Early-bird pricing is available through March 14, 2014! Learn more and register today at wcqi.asq.org.
The Global Voice of Quality
TM

FOLLOW the Fundamentals


Four data analysis basics will help you do big data projects the right way
by Ronald D. Snee, Richard D. DeVeaux and Roger W. Hoerl NEW TECHNOLOGY FOR acquiring, storing
and processing data is being introduced at an ever-increasing pace. In 2012, the White House launched a national Big Data Initiative.1 According to IBM, 1.6 zettabytes (1021 bytes) of digital data are now available. That is a lot of dataenough to watch high-denition TV for 47,000 years.2 Real-time data acquisition is becoming the norm. These developments are having and will continue to have major effects on how quality professionals and statisticians conduct product and process design and quality improvement projects.

In 50 Words Or Less

So what should we do? Is new thinking required, or will the usual approaches to data analysis work? A little thought suggests any change this big will require a new way of thinking. Big data are a collection of data sets that are too big and too complex to be processed using traditional database and data processing tools.3 Big data projects, as generally practiced today, seem to overlook four fundamental ideas that ensure successful outcomes: 1. Data quality. 2. Subject matter knowledge. 3. Sequential approaches. 4. Strategy.

Big data projects are becoming more prevalent in todays business world. To ensure project success: use high-quality data, leverage subject matter knowledge to put things in perspective, realize more than one data set or experiment is needed to solve the problem, and develop a strategy for conducting the project.

TECHNOLOGY

January 2014 QP 25

1. Data quality
Data quality is a major issue because big data projects typically involve diverse data sets collected in different environments. Whenever data are collected by multiple sources, the opportunity for omissions and errors is always present. The result is missing values, missing variables, measurement variation and denition conicts that can halt successful analysis. Unfortunately, much study and literature assume large data sets contain high-quality data measuring the right variables at the right frequency, and are devoid of missing values, missing variables or outliers. If only this were the case. Typically, a great deal of time and effort is needed to produce high-quality analysis. Consider a pharmaceutical companys quality improvement problem that involved a major product manufactured at ve different locations. One of the rst steps was to nd the vital few variables related to the quality issue. Unfortunately, three of the most critical variables identied by the quality improvement team were not being measured on the process in one location. Missing variables in a portion of the data set is not an uncommon occurrence and complicates the analysis. Missing data within recorded variables presents another common problem. In many data sets, unfortunately, it is unclear whether values recorded as zeros are actually zeros, or whether they represent missing values. Consider this online survey question: If you are experiencing technical issues, click here. Treating a nonclick as missing would result in assuming 100% are having technical problems. Another common data quality problem with big data is multicollinearity: Data are often collected without regard to survey or experimental design. This redundancy of a predictor results in a high correlation among them. This can make it difcult to separate the effects of the correlated variables on the response. Multicollinearity also can have effects on the performance of regression algorithms, such as the stepwise method and decision trees. Analysts of big data always should look for multicollinearity and take steps to mitigate its effects. Its important to understand the pedigree of the data how the data were generated and collected, including the process producing the product or service and the process used to measure.4 Clear understanding of the pedigree of the data is critical to the accurate assessment of the data quality. Even sophisticated algorithms cannot extract information that is not in the data.

meaning in themselves; they only have meaning within the context of a conceptual model of the phenomenon under study, wrote George E.P. Box, William G. Hunter and J. Stuart Hunter.5 Without subject matter (or domain) knowledge, you have no context within which to dene, analyze and interpret the results. Some have taken the position that with vast amounts of data, subject matter knowledge and scientic theory are no longer needed; you can solve problems purely and empirically with data alone.6 Unfortunately, many analysis blunders have occurred because analysts did not understand the phenomenon under study, and then they misinterpreted the results. Amazon.com, for example, used an automated algorithm to set an initial price on a new biology textbook, The Making of a Fly, at $1,730,045 in 2011. Even more shockingly, competitive websites benchmarked this price electronically and started raising their prices, resulting in Amazon.com doing the same. Shortly after, the books price on Amazon.com reached $23,698,656.7 Surely, a little common sense and understanding of how textbooks sell would have ruled out such prices.8 Subject matter knowledgethe theory underlying the process and the data itselfcan be used fruitfully in many ways, including selection of variables and appropriate scales (for example, log, inverse and square root), selection of model form (for example, linear, curvilinear, multiplicative and which variables should be considered x versus y variables), interpretation of results and the ability to extrapolate ndings. You can do much more with data gathered and interpreted within the context of sound subject matter knowledge than you can with either data or theory alone. From a practical point of view, understanding the process that produced the data provides context that helps frame the problem, create the plan for analysis, understand the results of the analysis, and guide the creation and implementation of the solution.

3. Sequential approaches
Experience has taught us important problems are rarely solved using a single data set or experiment. The Wright Brothers, Thomas Edison and, more recently, Bill Gates and Steve Jobs all achieved success after many rounds of trial and error. Fortunately, they learned with each attempt, gradually building up their understanding (subject matter theory) of the problem they were addressing. This is a key aspect of the scientic method: becoming a little smarter with each round of experimentation, gathering

2. Subject matter knowledge


Subject matter knowledge is the next consideration that is underappreciated in current literature. Data have no

26 QP www.qualityprogress.com

TECHNOLOGY
better and more relevant data until you eventually solve the problem. Obviously, organizations such as Apple and Google never stop learning: They indenitely continue this sequential approach, leading to continuous learning, improvement and innovation in products and services. Unfortunately, there seems to be an implicit assumption in much of the big data literature that all problems can be solved with one data set and one analysis. Online websites, for example, such as www.kaggle.com are now hosting online data analysis competitions. The original problem, however, is reduced to: What is the best model I can create from this data set? The data set, of course, should not be the focus of your effortsthe problem you are solving should be the focus. A better question would be: What can I learn from this data set that would help me collect even better data in the future so I can solve the original problem and continuously learn? A good analysis of a specic data set typically will answer some questions, but will almost always lead to more questions requiring the collection and analysis of additional data sets. It should not be overlooked that the nalor near nalmodel also should be used to predict an independent data set to conrm and measure the prediction accuracy of the model. Note that an additional data set, collected at a different time and under different circumstances from the original data set, goes well beyond holding out some of the original data as a prediction set, sometimes referred to as cross validation. Your strategy must move beyond the one-shot study mindset if you are to be effective over the long term. It may be prudent to consider the current model as a hypothesis generator for the next investigation rather than conrmation of an existing hypothesis. It is also important to create a communication plan and process for the project. The people affected by the project must be continuously and clearly reminded of the purpose of the project and informed of progress made to date, including the schedule for project completion. Because people take in and process information differently, a variety of mediasuch as email, video, one-on-one meetings and small discussion groupsshould be used, depending on the nature of the project. The affected people should be empowered as needed to perform effectively in their new roles in the creation and implementation of the project solution. This will include training and education, and perhaps new equipment. Generating short-term wins means dividing the work into pieces that can be completed in less than three to six months. People are impatientthey want to see progress. Short-term wins demonstrate that big data projects can be successful and return useful benets. When projects run longer than three to six months, people move to different assignments, business conditions change affecting the project and the organization loses interest.11 Naturally, some projects cannot be completed in less than three to six months. An effective approach for such situations is to create subprojects that can be completed quickly, thus satisfying the organizations need to see progress. in the problems solution? The organization will be more interested in providing needed support and resources when the sense of urgency is well understood. Next, it is critical to have a guiding coalition of inuential leaders that believe in the initiative and will help ensure its success. The support and involvement of the guiding coalition will be needed throughout the projects life. The guiding coalition also can help develop the vision for the project: What things will be in place and what it will look like when the project is complete? The construction of the vision is similar to Steven R. Coveys recommendation of beginning with the end in mind.10 The vision helps the affected people see themselves in the creation and implementation of the solution to the problem.

Clear understanding of the pedigree of the data is critical to the accurate assessment of the data quality.

4. Strategy
Early in the planning of a big data project, its prudent to strategize how the project will be conducted. A strategy is an overall high-level approach to attacking a problem. The strategy denes how you will win. It denes the choices to be madewhat you will and will not do. During World War II, for example, the Allies strategy was to win in Europe rst. Thus, when a choice had to be made regarding resources, Europe got the resources before the Pacic war theater. The following aspects of strategy are based on the recommendations of John P. Kotter.9 First, it is important to develop a sense of urgency: Why it is important for the organization to address this problem at this time and how interested is the organizations leadership

January 2014 QP 27

TECHNOLOGY
Framework
Over the years, we have learned that problem solving, particularly in a team environment, is most effective when guided by a framework that provides the team a step-by-step process to follow. As a result, the team knows what work is to be done (team alignment), in what sequence and where the team is in the problem-solving process at any point in time. Two well-known examples of such problem-solving frameworks are plan-do-checkact and dene, measure, analyze, improve and control. Big data projects are typically related to large, complex and unstructured problems. Data come from many different sources. Several groups are involved, each with its own agenda and its own ideas about what the problem is and how to nd the solution. As a result, the problem is typically ill-dened, requiring work to decide what problem to attack and who should be on the team. After the team is formed and the work begins, the strategy for how the problem will be addressed, and the tactics of the analysis must be worked out. Such a situation is similar to the problems addressed with statistical engineering, which has an associated framework to guide the work.12-15 While there is no magic number of easy steps to take when conducting such projects, the work typically follows the following phases: Identify high-impact problems that are doable and that management will support. Create structure for the problem. Big data problems are typically unstructured initially. Understand the context of the problem, such as the process in which the problem resides, data types and sources, historical background and agendas of stakeholder groups. Develop an overall strategy, as discussed earlier. Establish tactics on how to implement strategy. Paying attention to these phases will signicantly increase the success rate of big data projects.16
REFERENCES AND NOTES
1. Tom Kalil and Fen Zhao, Unleashing the Power of Big Data, White House Ofce of Science and Technology, Ofce of Science and Technology blog, April 18, 2013, www.whitehouse.gov/blog/2013/04/18/unleashing-power-big-data. 2. Mike Ebbers, 5 Things to Know About Big Data in Motion, IBM DeveloperWorks blog, IBM, June 12, 2013, www.ibm.com/developerworks/community/ blogs/5things/entry/5_things_to_know_about_big_data_in_motion?lang=en. 3. Wikipedia, Big Data, http://en.wikipedia.org/wiki/big_data. 4. Ronald D. Snee and Roger W. Hoerl, Inquiry on Pedigree, Quality Progress, December 2012, pp. 66-68 5. George E.P . Box, William G. Hunter and J. Stuart Hunter, Statistics for Experimenters, John Wiley and Sons, 1978, p. 291. 6. Chris Anderson, The End of Theory: The Data Deluge Makes the Scientic Method Obsolete, Wired Magazine, June 23, 2008, www.wired.com/science/ discoveries/magazine/16-07/pb_theory. 7. Kevin Slavin, How Algorithms Shape Our World, TED Conference presentation, July 21, 2011, www.ted.com/talks/kevin_slavin_how_algorithms_shape_ our_world.html. 8. Richard D. DeVeaux and David J. Hand, How to Lie With Bad Data, Statistical Science, Vol. 20, No. 3, 2005, pp. 231-38; discusses several other examples of bad data. 9. John P. Kotter, Leading Change, Harvard Business School Press, 1996. 10. Steven R. Covey, Seven Habits of Highly Effective People, Franklin Covey, 1989. 11. William H. Gates III, Business @ the Speed of Thought, Warner Books, 1999. 12. Roger W. Hoerl and Ronald D. Snee, Closing the Gap, Quality Progress, May 2010, pp. 52-53. 13. Ronald D. Snee and Roger W. Hoerl, Engineering an Advantage, Six Sigma Forum Magazine, February 2011, pp. 6-7. 14. Ronald D. Snee and Roger W. Hoerl, Proper Blending, Quality Progress, June 2011, pp. 46-49. 15. Ronald D. Snee and Roger W. Hoerl, Further Explanation, Quality Progress, December 2010, pp. 68-72. 16. The success rate of big data projects will be the subject of a future Quality Progress Statistics Roundtable column or feature article.

identication and formulation to solution implementationand the development of an overall strategy or plan of attack can decrease the probability of success. Big data analytics are here to stay, and thats good news. Careful attention to the fundamentals of data analysis can lead to very useful and protable problem solutions and process improvements. The secret to success is to understand and use the fundamentals. QP
2014 Ronald D. Snee, Roger W. Hoerl and Richard D. DeVeaux

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 ASQs Shewhart and Grant medals. He is an ASQ fellow and an academician in the International Academy for Quality. RICHARD D. DeVEAUX is the C. Carlisle and Margaret Tippit professor of statistics at Williams College in Williamstown, MA. He has received ASQs Shewell and Frank Wilcoxon awards and is a fellow of the American Statistical Association.

Not replacing the scientic method


The glass is half full: Big data offer a unique opportunity, but there can be many pitfalls along the way. Using powerful statistical software packages incorrectly can prevent effective analysis of big data sets. Ignoring statistical engineering fundamentals can lead to ineffective and perhaps wrong solutions. Not understanding data pedigree, use of sequential approaches, integration of subject matter knowledge in all aspects of the problem-solving processproblem

ROGER W. HOERL is the 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 ASQs Shewhart Medal and Brumbaugh Award, and an academician in the International Academy for Quality.

28 QP www.qualityprogress.com

New Books Available Through Quality Press


The ASQ Pocket Guide to Root Cause Analysis
The purpose of this pocket guide is to provide you with easily accessible knowledge about the art of problem solving, with a specific focus on identifying and eliminating root causes of problems. Item: H1460

ISO 9001:2008 Explained & Expanded


The overriding purpose of this book is to help the reader weave his or her ISO 9001 quality management system (QMS) into the very fabric of their organization. Item: H1446

The ASQ Pocket Guide for the Certified Six Sigma Black Belt
This pocket guide is perfect for Black Belts to use on the job by clarifying the many concepts and tools that can keep projects on track to successful completion, and perfect for training your project team. Item: H1441

ASQ Quality Press offers the most up-to-date information to support your quality program. All books are peer reviewed and continually being updated to ensure you have the latest in quality knowledge and tools.

Learn more about these books through the Quality Press bookstore at asq.org/quality-press.
TRAINING CERTIFICATION CONFERENCES MEMBERSHIP PUBLICATIONS

by Nicole M. Radziwill and Tracy Owens

The relationships among technology, innovation and quality are based on creating new value and sustaining the ability to continue creating it. Leveraging these relationships can help in pursuing the quality ideal, which involves releasing your creative spirit. Real-life examples illustrate how others tapped their innovative capacity to create new value.

In 50 Words Or Less

INNOVATION

Perspective
Leverage the relationships among innovation, technology and quality to unlock your creative potential
IT IS NOT UNCOMMON in QP and other contemporary business
magazines to nd inspiring stories about teams that have partnered with customers and stakeholders to enthusiastically co-create new, innovative products or novel technologies. What is not often explored is the symbiotic relationship between technology and innovationand how the processes and structures used to innovate are themselves technologies. The framework for the ASQ quality body of knowledge describes four stages of the quality journey: 1. The pursuit of personal excellence. 2. The pursuit of operational excellence. 3. The pursuit of organizational excellence. 4. The pursuit of the quality ideal, which includes an emphasis on transformation, radical or discontinuous change, and methods for releasing the creative spirit.1

Fresh

January 2014 QP 31

How can you leverage the relationships among technology, innovation and quality to enhance your personal innovative potentialreleasing that creative spirit to actively pursue the quality ideal? The stories shared here provide some ideas for how you can make it happen through deliberate, sustainable value creation.

Social and organizational networks, because they connect you to new ideas and the people who create them. Art, because it often provides you with the inspiration to create other material objects. While innovation is a social process requiring collective knowledge and experience, technologies are inherently social products or outputs. Quality systems provide the glue to produce what is needed consistently, and to connect people with the innovations that will meet their needs. The relationships among technology, innovation and quality are based on creating new value and sustaining the ability to continue creating it in the future. Innovation is, after all, quality for tomorrow. There are two ways new value can be envisioned and created in a future context: peripheral knowledge and combinatory play. These approaches can be applied separately or together. The end result is the same, though: new insights, new ideas and new developments.

Sustainable value creation


According to the Random House Websters Unabridged Dictionary, technology is the sum of the ways in which social groups provide themselves with the material objects of their civilization.2 As long as there is a tangible artifact or outcome such as a product, process, framework or toolthat advances human capabilities, there is technology. Looking at it this way, lots of things can be considered technologies, including: Quality systems, because they provide the structures that enable you to consistently and reliably craft products and deliver services.

Peripheral knowledge
NEED NEW IDEAS? Having difculty solving a vexing problem? Just change your contextthats the essence of opening up to peripheral knowledge. The recently developed topic of peripheral knowledge3 has stimulated conversation among ASQ members and others.4 When your mind is focused squarely on a specic issue, you can become myopically entrenched in the problem and unable to pull back and see the bigger picture. Completely pulling yourself or your team out of your typical day-to-day environment can have the benecial effect of revealing new possibilities through similar, yet unrelatedperipheralproblem contexts. Because you have been looking at one specic problem so intently, you may be able to nd a parallel problem in a basketball game, trade show, restaurant or some other environment unrelated to your current context. This is exactly what happened to Jim Mazotas, an entrepreneur from Dublin, OH. While watching his children play on the beach, he noticed that nearly all the kids thereregardless of agewere carrying some sort of electronic device. Whether it was a mobile phone, a music player, or a handheld reader or game, each child tended to divide his or her personal time between typical beach behavior and catching up on their media players. He also noticedas a lot of parents dothat there are many strangers on a crowded beach, and its sometimes possible to lose sight of a child. Mazotas mind began to generalize and think of ways these devices could possibly help track and locate a child who has gone astray or is missing. The result of the peripheral knowledge that Mazotas picked up thanks to brainstorming on the beach was SafeHouse, a collection of programs that enable a handheld device to send a signal with its location to a parents device.5 In addition, the childs device will use all the technology it has available, such as its global positioning system, camera, microphone and accelerometer, to gather context-sensitive information about the childs situation. The childs device also will be locked on open when a distress signal is sent, preventing any manual reset until the device is found.

Virtual watering hole


In addition to nding innovation based on the capabilities of the technology being used or observed, there are several technology-enabled collaboration tools available to help stimulate innovation through the processes of idea generation and execution. In their book, Innovation: The Five Disciplines for

32 QP www.qualityprogress.com

INNOVATION

Creating What Customers Want, Curtis Carlson and William Wilmot describe the innovation watering holea recurring gathering in a workplace where people with new ideas can meet to share and discuss them in a safe and constructive environment.6 The ideas owner prepares a 30-second statement of value and presents that value proposition to the participants at the watering hole. Some attendees are given the role of green hat and their job is to point out the best features of the value proposition. The same number of individuals play the role of red hat to explore how to make the value proposition better, stronger or more compelling. The shared purpose of both hats is to help the ideas originator rene the idea, improving its chance of being successful when pitched to senior decision makers. A virtual watering hole can be created with a tool like Spigit. Founded in 2007, Spigit promotes idea generation
7

with as few words and as many pictures and visual aids as possible. The technology at the time limited her to storing materials on CDs, which took several minutes to load and access. This was not expedient for the user. The introduction of local area networks enabled her to distribute her materials to the intended users much more quickly. Loading les was still time consuming, though, so the materials she created still were not used as often as they could have been. Undaunted, she kept surveying the environment for new technologies and new opportunities that her organization, Nessis, could leverage to solve this challenge. Niles breakthrough came in 2006 when her team was able to program web-enabled visual work instructions. Since then, her company has kept pace with new technology by integrating work instructions with clients bills of materials, expanding into 3-D graphics and enabling tablets to access training materials faster than ever. Nessis has accelerated the innovation process through its dedication to continuous learning about the environment in which it is embedded. For them, acquiring peripheral knowledge is a matter of habit.9

within an organization by accepting idea submissions, facilitating watering hole-type discussions and gathering advice to be posted for the ideas submitters and others to read. The software is enabled with voting capability so when ideas are competing for the same resources, they can be effectively prioritized. Innovation is accelerated because peripheral knowledge can be leveraged across an entire organization in a manner that is always up-to-date and aligned with its priorities.

Evolution of context
The story of Kathleen Niles is told in The Executive Guide to Innovation.8 Niles worked for several years as a corporate trainer, learning that people learn best when they are given the information they need at the moment they need it, and that long, verbose descriptions of tasks are not always easy to comprehend. In 2000, she began to develop work instructions and training material
THE IDEA for SafeHouse, a technology that allows parents to track the location of their children using handheld devices, was sparked by peripheral knowledge obtained in a new context.

January 2014 QP 33

Uncovering invisible links


New ideas will not always materialize automatically, instantly crystallizing when you walk outside the ofce door. It may be necessary to force the association of new ideas to save time. Fortunately, tools such as Genrich Altshullers theory of inventive problem solving (TRIZ), which was developed in the late 1940s to promote this kind of free association, have been around for decades.10 TRIZ (an acronym of its Russian name) presents 40 different design constructs to stimulate innovation by encouraging the innovators to resolve technological contradictions. Another example is the Idea Generator app, which matches three random words together when you shake a handheld device. By considering unrelated words such as musical, hologram, and instruction in the context of your own current challenges, something entirely

new may emerge for a market that was previously unserved or underserved.11 Not all free association requires a technique or an app. It may be sufcient to simply encourage your team to imagine how the technologies it is using or developing today might be introduced into another context. General Electrics (GE) leadership team in Hong Kong has been asked to do just thisdevelop products or processes outside its established lines of business. The team members collaborate with GE engineers all around the world to explore new possibilities. One pending success story from this collaboration is the development of an inexpensive, handheld, portable ultrasound machine that can be used to send vital information to physicians before they are even able to see a patient.12

Combinatory playgrounds
THE DYNAMIC INTERPLAYS among technology, innovation and attention to quality can be experienced through combinatory play, which is Albert Einsteins term for combining and recombining unrelated ideas within the context of a problem.13 While tools such as TRIZ and the Idea Generator app can help you think more expansively about a current challenge, sometimes you arent pressured by a problem that must be solved immediately. Instead, the problem and the problem-solving environment emerge over time, along with the innovations that ultimately result. In cases like these, it can be benecial to explore new possibilities in a more unbounded way.

Technology helps see possibilities


The next three stories are inspired by two highly dynamic combinatory playgrounds in which radical innovation thrives. One is the annual Burning Man event in Nevada, where nearly 70,000 people gather to create a temporary city in the harsh environment of the Black Rock desert. Another is the Business Innovation Factory (BIF), a community of innovation enthusiasts who envision and test new models for delivering value. BIF is led by Saul Kaplan and based in Providence, RI, where its annual summit is held each fall. Easton LaChappelle of Colorado didnt see the possibilities at rst. All he wanted to do was create a robotic hand in his spare time because he thought it would be really cool.

PRESIDENT BARACK Obama shakes the hand of high school student Easton LaChappelles 3-D printed, brain-controlled prosthetic arm at the White House Science Fair in 2013.

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INNOVATION

He was limited to the meager tools he already had available: resources on the internet, shing wire, a collection of servo motors and a pile of Legosbut no funding or staff, and certainly no formal education about how to pursue his vision.14 While building an early version of the hand, he realized how expensive and challenging it would be to machine all the parts for the light, exible arm he was envisioning. At about the same time, he met a girl at a science fair who had been born without an arm. She wore an $80,000 prosthetic controlled by an implant in her spine, which would be re-implanted at great pain and expense as her body grew to maturity. Knowing he could help her and others like her if he kept rening his design, he started exploring 3-D printing to create a prosthetic arm that would be affordable to nearly everyone.15 Three years and several prototypes later, hes developed a brain-controlled prosthetic arm that provides haptic feedback to its wearer to emulate a sense of touch. Even President Barack Obama has shaken its hand. LaChappelle open-sourced his design and has already shared it in many places, including on YouTube and in Make: Magazine.16 The best part? The materials to build the arm cost under $300 so his innovation can have the broadest possible impact for those who need it. Almost single-handedly (no pun intended), LaChappelle has created a revolutionary new technology that has the potential to transform the entire industry of prosthetics. Now, he can focus more on his next major project: graduating from high school this spring. trolled by three tiny Raspberry Pi computers. When the sensors were triggered, sound clips were selected and played by the software, which he wrote in Python, a highlevel programming language. His goal for the technology was that it would provide a reliable and consistent user experience. Unfortunately, when Emery deployed his creation in the harsh Black Rock desert, his code wasnt performing the way he had expected. The sensors were being triggered in unexpected ways, and dedication to his standards of quality pushed him to quickly solve the problem. Soon, the challenge became obvious: I always try to anticipate potential problems and write my code to avoid them, but I didnt expect a giant re-breathing dragon, wrote the projects software developer. The dragon sculpture was a couple of hundred yards from the MerKaBa Project on the playa. Every time it belched ames, it set off the infrared sensor pointed in its direction. The infrared sensors can detect humans up to 30 feet away, but a re-breathing dragon generates a lot more heat. Next year, Ill plan for dragons!19
XIAO XIAOS MirrorFugue is a technologically enhanced player piano that captures the facial expressions, body movements and hand positions of the musician in a projected reection. (Photo courtesy of Intersect by Lexus)

Quality guides technological decisions


Michael Emery wanted to immerse people in his art to provide them an inspiring experience, so he built the MerKaBa, a portal of sound and image to transport participants beyond consensus reality.17 This art installation, which was built in the temporary metropolis of Black Rock City, NV, during the 2013 Burning Man event,18 is a nine-foot dome made of steel with fractal patterns plasma cut into each of the domes faces. Sound and lighting effects were designed to respond to visitors proximity and movement patterns, giving them the opportunity to participate in the creation of art. Modern art, such as Emerys MerKaBa, are works of technological complexity and artistic performance. His artwork integrates a rotating column of mirrors, six video projectors and 12 infrared motion sensors all con-

Unlocking potential, assessing progress


The role of art is to support and inspire people in their search for meaning and purpose, a process which often naturally integrates combinatory play. Sometimes technology can help you nd that meaning and purpose,

January 2014 QP 35

INNOVATION

and as a result, being more deeply connected with inner sources of inspiration can help you unlock your creative potential. With your power tapped, you can more readily share the knowledge, skills and gifts you have with those around us. This enhances productivity and stimulates the authentic, engaged contributions that lead to innovation. Xiao Xiao, a doctoral candidate working in the Massachusetts Institute of Technology Media Lab, has internalized this lesson in MirrorFugue, a technologically enhanced player piano she developed.20 Recognizing that so much of the richness of piano performance lies in the expressions and body language of the player, her invention captures the facial expressions, upper body movements and hand positions of a musician in a projected reection onto the piano itself, along with a recording of the song that musician has played. The entire performance can be replayed, along with the music, on the MirrorFugue piano. Multiple musicians can be replayed at once, and you can even play along with the recordings. Although created to address the need for improving piano pedagogy and making it possible for students to learn more effectively without an in-person instructor, MirrorFugue provides the opportunity to interact with content over distance and time as well as to visualize musical structure.21 The device can be used to learn from experts in a richer, more immersive way, or can even be used to provide a musician with a creative way to see how much he or she has improved and progressed. Imagine being able to play a duet with yourself as a child, and then again as an adult: What better way to viscerally explore the extent of your own continuous improvement?

boundaries. Get out of your connes; immerse yourself in a new and different environment; and see, feel or experience something new. You may leave with a lot more than you expected. QP
REFERENCES
1. ASQ, Guide to the ASQ Quality Body of Knowledge, http://asq.org/2009/04/ guide-to-the-qbok.pdf (case sensitive). 2. Technology, Websters Random House Unabridged Dictionary, Random House Inc., 2013. 3. Wharton School of the University of Pennsylvania, How Seemingly Irrelevant Ideas Lead to Breakthrough Innovation, Knowledge@Wharton, Jan. 30, 2013, http://knowledge.wharton.upenn.edu/article/how-seemingly-irrelevant-ideaslead-to-breakthrough-innovation. 4. Jane Keathley, Peter Merrill, Tracy Owens, Ian Meggarrey and Kevin Posey, The Executive Guide to Innovation, ASQ Quality Press, 2013. 5. SafeHouse Inc., www.safehouseinc.com. The website will go live Jan. 30. 6. Curtis R. Carlson and William W. Wilmot, Innovation: The Five Disciplines for Creating What Customers Want, Crown Business, 2006. 7. Spigit, www.spigit.com. 8. Keathley, The Executive Guide to Innovation, see reference 4. 9. Ibid. 10. Nicole Radziwill, All About TRIZ for Innovation, Quality and Innovation, http:// qualityandinnovation.com/2012/02/04/all-about-triz-for-innovation. 11. Jeff Dyer and Hal Gregersen, Learn How to Think Different(ly), HBR Blog Network, Sept. 27, 2011, http://blogs.hbr.org/2011/09/begin-to-think-differently. 12. Diana Villiers Negroponte, Stimulating Innovation on the Periphery, Brookings, Jan. 27, 2012, www.brookings.edu/blogs/up-front/posts/2012/01/27stimulating-innovation-negroponte. 13. Jacques Hadamard, The Psychology of Invention in the Mathematical Field, Dover, 1945. 14. ZietNews.org, Easton LaChappelles TED Talk3-D Printed, BrainPowered Robo-Arm, www.zeitnews.org/natural-sciences/materials-science/ easton-lachappelles-ted-talk-3d-printed-brain-powered-robo-arm. 15. Business Innovation Factory, No Time for School, www.businessinnovationfactory.com/iss/stories/no-time-for-school. 16. Stett Holbrook, Teen Creates 3-D Printed, Brain-Powered Prosthetic Arm, Make: Magazine, http://makezine.com/2013/02/08/teen-creates-3d-printedbrain-powered-prosthetic-arm. 17. Michael Emery, The MerKaBa Project at Burning Man 2013, Kickstarter, www.kickstarter.com/projects/1813995473/the-merkaba-project-at-burningman-2013. 18. Burning Man, www.burningman.com. 19. Raspberry Pi in the MerKaBa Project at Burning Man, Raspberry Pi, www. raspberrypi.org/phpBB3/viewtopic.php?t=54812&p=416899 (case sensitive). 20. Xiao Xiao, MirrorFugue, Xiao Xiao portfolio, http://portfolio.xiaosquared. com/mirrorfugue. 21. Xiao Xiao, Anna Pereira and Hiroshi Ishii, MirrorFugue III: Conjuring the Recorded Pianist, New Interfaces for Musical Expressions 2013 conference, May 27-20, Daejeon, Korea, http://xiaosquared.com/portfolio/pdf/mf_nime.pdf.

Let it ow
Innovation is a social process, and inspiration can come from people and situations you might not always consider at rst. Shifting your teams attention to an unrelated area can give its members the fresh perspective needed to truly innovateto acquire new knowledge to develop new technologies that will bring new value in the marketplace. Continuous learning can help expand peripheral knowledge. Free association and combinatorial play can expand your awareness of opportunities and possibilities. The theme connecting all these stories, however, is personal: To expand your innovative capacity, make the effort to explore what lies beyond your own personal
TRACY OWENS is a lean practice leader at Ohio Six Sigma in Dublin, OH. He has a masters degree in international business from Seattle University in Washington. He is a founding member of ASQs Innovation Interest Group and coauthor of The Executive Guide to Innovation (ASQ Quality Press, 2013). Owens is an ASQ-certied quality engineer and a Baldrige examiner for the state of Ohio. NICOLE M. RADZIWILL is an assistant professor at James Madison University in Harrisonburg, VA, and chief sorceress of the Burning Mind Project. She earned a doctorate in technology management and quality systems from Indiana State University in Terre Haute. An ASQ fellow, Radziwill is an ASQ-certied quality manager and Six Sigma Black Belt.

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by Satya S. Chakravorty
In 50 Words Or Less

Service
MACHINES HAVE EVOLVED from prehistoric tools to sophisticated 21st century devices. Man has been and always will be fascinated by machines and will continue to dream about building something that does what everyone thinks is impossible. During the Renaissance, Leonardo Da Vinci designed a multitude of devices, including parachutes, and studied the ight of birds and their structure. He also romanticized concepts of ying machines in beautiful drawings. In the late 1800s, science ction novelist H.G. Wells wrote about the concept of time travel in The Time Machine. He described a vehicle that allows an operator to
1 QP www.qualityprogress.com

The heavily used U.S. Air Forces C-130 Hercules requires regular maintenance to continue ying wartime and peace missions. One team at a military facility mixed and prioritized several quality improvement methods to retool how it repairs and restores this aircraft. Improvements reduced defects by 84% and saved nearly $1.5 million.

CASE STUDY

Team prioritizes quality methods to retool how it maintains, repairs and keeps the C-130 Hercules ying

travel purposefully and selectively.1 Throughout the years, machines have become synonymous with devices that not only facilitate new outcomes, but also produce exceptional results. Fast forward to today. Man continues to dream and to advance the concepts of ying machines, and build aircraft that are bigger and better than ever before. One such machine is the C-130 Hercules. One team at a military facility in central Georgia brought together several quality concepts and methods to retool the way it repairs, maintains and keeps this large transport aircraftone of the most heavily used ying machines in the U.S. Air Forcein service.
January 2014 QP 39

In doing so, the aircrafts programmed depot maintenance (PDM) team produced exceptional results at Warner Robins Air Logistics Complex (WR-ALC) in Warner Robins, GA. From its efforts, in fact, the C-130 PDM team received the prestigious 2012 Secretary of Defense honor known as the Robert T. Mason Award for Maintenance Excellence. Consider this: The C-130 PDM team dramatically improved its due date performance from 43.86% in 2010 to 98.41% in 2012. At the same time, C-130 PDM team reduced its work in process (WIP) by 68.63%, from 51 to 16 aircrafts, putting 35 additional aircraft back in service as U.S. warghters. The C-130 PDM teams ow daysthe time it takes for the grounded aircraft to progress through the maintenance stageswere reduced by 32.4%, from 102 to 40 days, yielding an average monthly savings of $1.47 million and resulting in lower costs (see Table 1). In concert with these notable achievements, the C-130 PDM team kept an intense focus on product quality and compliance, resulting in an 84% reduction

in accepted customer reported defects. Throughput attained a sustained increase of 30% against the 2010 baseline, increasing output from one aircraft per week to 1.3 aircraft per week. After a strategy was developed and implemented, the C-130 leadership focused on execution to produce results. Leaders prioritized improvement methods (for example, theory of constraints (TOC), lean and Six Sigma) using a deceptively unpretentious squiggly line or a damped sine wave (see Figure 1). In physics, damping is an effect that reduces the amplitude of oscillations over time. The theory of linear damping was originally developed more than a century ago and is still of vital interest to physicists, mathematicians and engineers. This theory plays a central role in explaining the stability of many mechanical and electrical systems. In a mechanical system, for example, a spring may be used as a damping effect to reduce the impact of weight. In an electrical system, a capacitor (C) may be connected to an inductor (L) and a resistor (R), giving rise to an LRC circuit. As a damping effect, improvement methods were prioritized in three somewhat overlapping phases, namelyimmediate, renement and perfection (the art of the pos-

Performance
Performance PDM WIP (number of aircraft)

/ TABLE 1
2010 43.86% 51 102 1 1 2011 61.31% 36 69 0.75 1.26 2012 98.41% 16 40 0.16 1.30

sible) for the C-130 PDM team. The immediate actions were based on TOC principles. The renement actions centered on lean concepts, and the perfection actions relied on Six Sigma or more complicated procedures. The idea was to control the release of work, focus on improving efciencies and ne tune the process.

Due-date performance (percentage) Dock ow days (calendar days) Customer reported defects (number per aircraft) Throughput (number of aircraft per week)
PDM = programmed depot maintence WIP = work in process

The squiggly line


Immediate Amplitude

/ FIGURE 1
Perfection

The PDM process


Many U.S. Air Force aircraft undergo PDM. Depot maintenance involves challenging work such as extensive aircraft disassemblythat is not performed at the eld installations. Instead, it occurs at specialized facilities such as the WR-ALC. The word programmed refers to maintenance that occurs on a schedule rather than in response to a specic aircrafts condition. Intermittent PDM is established and is essential to keeping a C-130 aircraft operating
Process variation

Renement

safely and effectively. In other words, PDM, or preventive maintenance, increases capability by extending the

Amplitude

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CASE STUDY

C-130 programmed depot maintenance process


Strip Inspect Repair Build up

/ FIGURE 2
Fit test

Material

Routed components

Tools

Support equipment

Engineering

Functional test

Fuels

Nondestructive inspection

Depaint and paint

aircrafts life. The C-130 PDM process is performed in several buildings at the WR-ALC and consists of ve major steps, as shown in Figure 2. 1. Strip. After removing the fuel from the aircraft (defueling), the aircraft is stripped of most of its components, including engines, ight controls, thrust reversers, ramps, doors and panels. 2. Inspect. This includes a detailed inspection of corrosion, cracks or high-stress areas. 3. Repair. Most of the repair activities are performed. 4. Build up. This includes putting the aircraft back together, reinstalling the engines, ight controls, thrust reversers, ramps, doors and panels. 5. Fit test. Green runs are performed on the aircrafts engines and ight controls, which are operated while the aircraft is still on the ground. The aircraft begins functional tests and a functional check ight. After the successful completion of this last step, the aircraft is placed back into service.

repair requirements (see Figure 3). In 2010, the total number of C-130 WIP was 51, and 15 of those aircrafts were queued for the strip or repair steps. The C-130 PDM teams meeting due-date performance stood at a dismal 43.86%, and ow days totaled 102, which was too many. Resources were spread thin across the C-130 PDM to cover the excess WIP on multiple shifts in multiple facilities. To complicate matters, there were far too many changes or modications to be incorporated into the C-130 aircrafts. For example, intensive planning was underway for the new C-130J Super Hercules, which would affect the C-130 PDM within a few months. These challenges directly affected the availability of the C-130 aircraft eet to fulll critical aircraft mission requirements in multiple theaters of operation.

Scheduled work package hours


32 30 28 Standard hours (000) 26 24 22 20 18 16 14 12 10 8 6 ACU work package has tripled during the last decade Work package size for special mission aircraft has more than doubled since FY00

/ FIGURE 3

The challenge
For more than a decade, C-130 aircrafts have experienced signicant increases in use rates and intensity of critical mission requirements in multiple theaters of operation. It is, therefore, not surprising that PDM requirements have increased signicantly, and weapon systems related to PDM in the Aircraft H model (ACH) and Aircraft U model (ACU) package hours have nearly tripled during the same period. The intensity of critical mission requirements places tremendous stress on the need to sustain the availability of C-130 aircrafts, which hinges, in part, on the ability of the C-130 PDM team to sustain or reduce ow days in the face of escalating inspection and

FY00 FY01 FY02 FY03 FY04 FY05 FY06 FY07 FY08 FY09 FY10 FY11 FY12 20.5 22.4 26.2 27.6 28.4 30.2 29.8 19.5 20.2 25.8 26.7 26.8 28.2 27.8

ACH 11.7 12.5 12.4 15.3 15.9 19.3 ACU 9.2 10.9 10.4 14.1 13.9 18 ACH = Aircraft H model ACU = Aircraft U model FY = scal year

January 2014 QP 41

The squiggly line


The strategic intent of WR-ALC is to be recognized as a world-class performer. Specically, the strategy articulates the continuous push to reach perfection by setting aggressive targets for quality, cost, safety and delivery improvements. For example, WR-ALC intends to improve delivery, or reduce ow days of aircraft by 20% every year while maintaining 100% on-time performance. In doing so repeatedly, the strategy is to generate capacity and bring in additional future workpossibly guaranteeing the long-term survival of WR-ALC. Keeping that strategy in mind, C-130 leadership developed a list of signicant problem areas for the PDM process. To address these problem areas, leadership prioritized the improvement methods into the three phases: The immediate phase was based on TOC principles, the renement phase centered on lean concepts, and the perfection phase relied on Six Sigma or other more complicated approaches.

WR-ALC. This resulted in little or no synchronization of PDM activities. There were considerable shortages of key resources such as equipment, tools and materials. The aircraft tail teams, which consist of representatives from production, planning, scheduling and material control, were pulled in different directions. The teams experienced difculty in working closely together and struggled to establish effective communication and cooperation. C-130 leadership made a bold decision to control the release of workload and reduce WIP of PDMs to six docks. This reduction mitigated the impact of shortfalls in key resources, resulting in improved synchronization of PDM activities. The aircraft tail teams began to work more closely together and improved communication and cooperation. Over time, the teams dened standard roles and responsibilities and worked aggressively to improve C-130 PDM performance on a shift-by-shift, tail-by-tail basis. To improve productivity as the aircraft tail teams worked more closely together, the C-130 PDM direct labor workforce was reorganized into dedicated crews to create a sense of ownership. Several dedicated crews were developed by skill or function: Disassembly crews prepared the aircraft for paint removal and dock entry. Dock crews accomplished inspections, repairs and reassembly. Rainbow tting crews completed inspection, repair or replacement of crucial wing joint components. Structural repair crews completed specic complex repairs to major aircraft structures. Post-dock crews, which consist of dedicated avionics technicians, focused on conducting outgoing checks prior to functional testing. On-site metal bond crews inspected and installed specialized composite repairs (for example, boron and graphite). This reorganization enhanced focus and effectiveness, resulting in improved yield. Additionally, the workforce experienced increased job satisfaction and more continuity of operations across shifts. The sense of ownership increased as crew members built mutual trust and worked together to their full potential. Ultimately, the increased productivity translated to increased levels of compliance with quality and safety standards and increased throughput as demonstrated by due-date performance gains.

Phase one: immediate


In TOC, it is acknowledged that all systems have constraints (bottlenecks), and the systems throughput is dictated by the processing capability of the bottleneck. Releasing more work than the process capability of the bottleneck sets in motion a vicious cycle of events, giving rise to high oscillations. As the systems WIP increases, the production oor becomes cluttered, resources are stretched thin and throughput begins to suffer. As more work continues to be released, the system is inundated with WIP, and production expands to other areas to accommodate the WIP. This puts enormous pressure on the already-stretched resources, and throughput suffers even more. Over time, the situation often worsens, and the amplitude of the cycle increases as the system experiences higher oscillations, resulting in instability. One way to dampen or slow the high oscillations is to control the release of work and focus on WIP reduction and effectively using resources. Initially, there was little or no control on the release of work to the C-130 PDM process. As a result, overtime was needed, and WIP relating to C-130 aircraft was spread across 10 docks, with additional aircraft queued in various stages of disassembly and reassembly. These docks were physically located in four different facilities, spread across more than one mile in the

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CASE STUDY

By controlling work release, focusing on reducing WIP and gaining resource concentration, there was a steady increase of throughput and due-date performance. As the C-130 PDM cleared excess WIP, PDM ow days began to drop steadily, falling from 102 in October scal 2010 to 79 days in October scal 2011. These additional days provided for improved agility to respond, reduced reaction time, and enhanced the close air support and other airlift missions for which the C-130 aircraft is uniquely capable (see Figure 4).

PDM owdays trend


200 180 160 140 Flow days 120 100 80 60 40 20 0 20

/ FIGURE 4
Difference in days Linear (difference in days)

Phase two: renement


As the high oscillations were reduced to moderate levels, lean principles were applied to the C-130 PDM to reduce or eliminate all forms of waste. Traditionally, there are seven categories of waste: overproduction, inventory, defects, motion, processing, waiting and transportation. It requires a

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great deal of contrived pursuit to identify waste, which sometimes can either be obscure or obvious. The C-130 production improvement applied lean principles to reduce or eliminate waste from all the steps of the PDM process and its supporting functions. Initially, C-130 leadership identied several problem areas and improvement opportunities throughout the PDM process. The top three high-priority improvement opportunities were: 1. Consolidation of facilities. 2. Use of the space in existing facilities. 3. Major changes to the supporting processes. Initially, C-130 PDM activities were performed in four different facilities spread across more than one mile in the WR-ALC. As the focus shifted to reducing WIP and increasing throughput, the C-130 PDM team was able to reduce the number of facilities required to perform maintenance by 50%, completely vacating two facilities (buildings 83 and 2316), and freeing 112,300 square feet of covered maintenance oor space to support other workloads. By eliminating the use of building 2316, the distance of associated aircraft tows from other facilities was reduced by more than one mile. By vacating building 83, sufcient facility space was created for simultaneous work on two additional C-17 aircraft, generating

140,000 work hours and $15.4 million in revenue. Within the remaining facilities, the C-130 PDM concentrated on space use, shop-oor organization, housekeeping (to maximize control), regulatory compliance and facilitating efcient aircraft maintenance. The six-dock conguration was reorganized using lean principles, such as 6S (sort, straighten, shine, standardize, sustain and safety). Establishing dedicated storage locations for toolboxes and specialized equipment dramatically reduced clutter around docked aircraft and facilitated maintenance stand repositioning. The facility oors were repainted to improve detection of potential foreign object debris (FOD) and to improve employee working conditions. Typically, FOD consists of nuts or bolts which, if sucked into an aircraft engine, can result in a fatal accident. These initiatives improved oor space use for the C-130 PDM, clearly increased safety and exibility, reduced FOD and improved aircraft access. In addition to the oor changes, the administrative ofces were reorganized to a day-shift team to provide dedicated ofce space and a swing-shift team to support the six-dock conguration. This initiative enhanced rst-line supervisor oversight of shop oor actions, while also increasing coordination when addressing tactical issues.

1-

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January 2014 QP 43

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The C-130 PDM implemented a host of changes aimed at streamlining support processes. One of the most important changes was the implementation of the maintenance requirements supportability process (MRSP). The core of MRSP logic was designed to enhance supportability through collaboration of WR-ALC, and its back-shop support activities, as well as Defense Logistics Agency and Air Force Global Logistics. The MRSP functionalities addressed the full scope of activities connected with the C-130 PDM, creating a library of master operations, which included resource requirements (material, tools and hazardous materials). The C-130 PDMs intense focus on deploy-

ing MRSP during the second half of scal 2011 directly inuenced daily maintenance activities. For example: Development of trigger packages for recurring repairs. Initiation of advance planning for phase two ndings to avoid schedule delays due to latent defects. Structured preparation of operational workbooks that detail all maintenance requirements for each tail number. Induction meetings organized for optimum communication of those requirements. Structured business processes for documenting and collaborating logistics system process change requests. Ongoing validation of material inventory center local stock quantities. Application of dedicated resources to accomplish advance planning of urgent PDM requirements for U.S. Coast Guard C-130 aircraft.

THE C-130 HERCULES


Lockheed Martins C-130 Hercules primarily performs tactical airlift missions. The C-130 operates throughout the U.S. Air Force, serving with Air Mobility Command, Air Force Special Operations Command, Air Combat Command, U.S. Air Forces in Europe, Pacic Air Forces, the Air National Guard and the Air Force Reserve Command. The aircraft fullls a wide range of operational missions in peace and war situations. It can operate from rough dirt strips and is the prime mode of transport for airdropping troops and equipment into hostile areas. Basic and specialized versions of the aircraft perform diverse roles, including: airlift support, Antarctic resupply, aero medical missions, weather reconnaissance, aerial spray missions, reghting duties for the U.S. Forest Service and natural disaster relief missions. The C-130 aircrafts role in executing military missions cannot be overstated. As the backbone of the Air Forces airlift capability, these aircrafts are absolutely crucial in providing supplies and positioning troops. The C-130 also provides close air support and an array of special mission capabilities to U.S. warghters on the ground in Operation Enduring Freedom and Operation New Dawn in Afghanistan. In addition, the C-130s are consistently relied on throughout the world for humanitarian missions, medical and resupply support, and repatriation details. Most recently, C-130s were pivotal in supporting refugees in Libya and Tunisia, earthquake victims in Turkey and tsunami victims in Japan. C130s also played an important role in many rescue operations in New York and New Jersey following the Hurricane Sandy devastation. S.S.C.

Phase three: art of the possible


As moderate oscillations were reduced to low levels, the C-130 PDM team applied Six Sigma or other more complicated approaches. In the C-130 PDM, Six Sigma incorporated complicated procedures for tending to the challenging repair requirements on numerous C-130 aircrafts. Working closely with engineers responsible for weapon system sustainment requirements, the C-130 PDM team identied exceptional defects and implemented complex repairs to restore aircraft structural integrity. In addition, complex changes to the C-130 PDM to improve the performance of the C-130 also were implemented. Examples of complex repairs and a complex process include: Repairing awed holes in the lower forward spar on the C-130 ACH. Nondestructive inspections revealed that at the fuselage station (FS), the main landing gear FS 517 beam had cracks that had to be repaired in critical fastener locations. Due to the location of the holes, using normal procedures to correct the damage would compromise minimum edge distance requirements (that is, extending too close to the radius). Based on detailed engineering guidance, the C-130 PDM team took extraordinary steps to complete the repairs. The process began with the stripping of the left inboard cavity in the left auxiliary fuel tank, removing the center wing box (CWB) attach angle (about 11

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CASE STUDY

The perfection (art of the possible) actions relied on Six Sigma or more complicated approaches.
feet long), removing the inboard and outboard drain trough, removing the gear box located directly to the left of the FS 517 beam, and cutting and trimming the left auxiliary tank and dry bay so the repair inside the auxiliary tank would t. The C-130 PDM team removed, inspected and reamed holes to oversize dimensions to accommodate fasteners common to the CWB attach angle that extended through the wing plank, FS 517 beam, web and the tapered titanium doublers. The CWB attach angle had to be routed to a back-shop activity for specialized machining services to mill out the location of the titanium doublers under the CWB attach angle. This level of structural disassembly, modication and reassembly required unusually complex maintenance work to return this aircraft to airworthiness for the warghter. Work on the C-130 ACH related to aging aircraft issues. Characteristically replete with aging aircraft issues, such as cracks and corrosion, this model was no exception. It required extensive composite doubler repairs and specialized repairs of awed holes, as well as repairs of cracks in two paratroop door frames. Compounding these challenges was the replacement of the cargo ramp that had been cannibalized earlier from this aircraft to support the mission of another aircraft. Initially, seeking support from the exchangeable repair line, the C-130 PDM team discovered no ramps were available through the standard supply chain. C-130 leadership located a potentially acceptable cargo ramp at one of the eld installations after days of exhaustive search of different databases. The cargo ramp was photographed in the eld, and digital photos were painstakingly examined to determine the suitability of repair requirements. After suitability was determined, the cargo ramp was shipped to WR-ALC. On arrival, the cargo ramp was thoroughly inspected, repaired and installed on the aircraft as it proceeded through the remainder of the PDM processes. Four xed release controls (FRC) were implemented at strategic points in the C-130 PDM. This implementation was difcult but necessary to continSATYA S. CHAKRAVORTY is Caraustar professor of operations management at Kennesaw State University in Kennesaw, GA. He holds a doctorate in production and operations management from the University of Georgia in Athens.

ue to improve the due date performance of the C-130 PDM. C-130 leadership staggered four gates in the entire C-130 PDM process (120 ow days) considering major jobs or change in scope. The predock FRC was located after 20 days and the inspection FRC was created after 20 days. At this point, two orders were placed (full kits one and two) for all the parts and components (for example, ight controls) needed for the repair and buildup of an aircraft. The repair and build FRC was placed after 40 days in dock, and nally, the postdock FRC was positioned after 40 days. Additional controls or milestones also were established within each FRC to enforce completion of major jobs to avoid overcommitment of resources that could possibly reduce throughput. Each FRC had a complete list of items that needed to be completed and veried by the appropriate authority before allowing an aircraft to go through the FRC. Implementation of FRCs improved due date performance and instilled quality through intermediate process discipline, while ensuring higher performance for support agencies.

Lessons learned
There is widespread confusion in organizations attempting to select a particular improvement method for their business environment. The difculty is that there are as many TOC zealots as there are lean and Six Sigma fanatics. There is a natural propensity for some organizations to choose one method over the other, and often a change in leadership triggers a change in method. To produce exceptional results, you must prioritize improvement methods or optimally mix them. QP
REFERENCE
1. H.G. Wells, The Time Machine, William Heinemann, 1895.

January 2014 QP 45

QUALITY IN THE FIRST PERSON

BY MANU K. VORA

Purpose and Principle


Lifelong volunteer and teacher reflects on the value of giving back
I LEARNED excellence from my father, who as a young man became a partner in a yarn spinning business and expanded it with his acumen and focus on customers. Education was highly valued in our home, and I was encouraged to succeed academically by being devoted to my studies, completing assignments on time and setting personal goals high. While I didnt have much time with my parentsI lost them both when I was 6my memory of them was present in my quest for personal excellence. At a young age, I developed a keen interest in math and science, which was kindled by great teachers who aroused my curiosity to explore these subjects in depth. My appreciation for learning and the condence my father instilled in me motivated me to earn my undergraduate degree in chemical engineering from the Indian Institute of Technology (IIT) Banaras Hindu University (BHU) in Varanasi, India. As an undergraduate, I volunteered to tutor my classmates who struggled academically. Little did I know at the time that many of the techniques I used to help classmates comprehend the materialsuch as synthesizing and generalizing concepts, using anecdotes, asking questions and maintaining a supportive dispositionwould later prepare me for my future career as a consultant and teacher. After graduating from IIT BHU, I left my home of India for Chicago as a Tata Scholar to complete my masters and doctoral degrees in chemical engineering at the Illinois Institute of Technology in Chicago. In India, my undergraduate courses were fairly advanced and patterned after U.S. engineering curricula, so I had an easy transition into graduatelevel studies. I also received an MBA from DeVry Universitys Keller Graduate School of Management in Downers Grove, IL. My engineering and business education helped me develop a customer-centric and analytical approach to solving problems. My rst job was at the Institute of Gas Technology in Chicago where I gained valuable experience in data collection, analysis and report preparation. A few years later, I joined AT&T Bell Laboratories and worked at the Holmdel, NJ, and Naperville, IL, locations. That career move turned out to be a signicant milestone in both my professional and personal livesit was at AT&T in 1985 when I was formally introduced to the eld of quality management.

Quality in focus
The quality movement had exploded in the United States, and this exciting and new focus had a presence at most major organizations. My mentor, John Delatore, director of systems engineering, and the organizations vice president, Edward Prell, understood that doing quality was not enoughquality must be a part of the organizations culture and values. They encouraged me to join a professional organization, receive technical certications and bring back quality resources and knowledge to share with my AT&T colleagues. As a lifelong learner and teacher, I jumped at the opportunity. I joined ASQ in August 1987 and in 1988 became an ASQ-certied quality engineer (CQE). I enjoyed my experience with ASQ greatly and sought additional opportunities to participate in committees and leadership roles: In 1987, I joined the Midwest National Quality Month committee as an ASQ volunteer.

46 QP www.qualityprogress.com

In 1988, I joined the ASQ Chicago Section Board as a member leader. From 1989 to 1994, I served on the ASQ certication board. From 1993 to 1999, I served as a chief judge of the Illinois Team Excellence Awards program. From 1994 to 1995, I chaired the ASQ Chicago Section. In 1996, I chaired the host committee for the 50th World Conference on Quality and Improvement in Chicago, which brought together more than 4,000 delegates from around the world. From 1996 to 2000, I was a member of the ASQ Board of Directors. From 2000 to 2002, I served as vice president of the ASQ board.

tions understand and implement quality management through my consultancy, Business Excellence Inc. I estimate that I have taught more than 5,000 people globally through my university and executive education offerings. It gives me great joy to pass on my practical experience to students who will apply their new knowledge to better serve their organizations. Joining ASQ fueled my passion for lifelong learning and networking with quality professionals on a global basis. As a member, I learned about best practices in quality management and was able to apply them to better serve my own customers. I was fortunate to have led several ASQ strategic initiatives, such as developing an ASQ volunteer leader recognition process,

YOUR QUALITY ADVISOR


Are you in a bind at work? Are you looking to clarify a term or methodology? Have you run into a problem where nobody seems to have the answer? Do you wish you had a quality mentor? Someone you could turn to when you run into a roadblock? You do. QPs experts will provide answers and insight to your toughest quality queries. Simply email your situation, question or problem to editor@asq.org, and QPs subject matter experts will offer their sage advice in our Expert Answers department.

Joining ASQ fueled my passion for lifelong learning and networking.


Since 2002, Ive served as a coach for the ASQ fellows process. Since 2004, Ive been a member of the Board of Examiners of the Asia Pacic Global Performance Excellence Awards program. These experiences helped me further develop my leadership abilities and interpersonal skills. I applied what I learned through ASQ resources and contacts to my career at AT&T. ASQ involvement prepared me to serve as an internal consultant for quality improvement projects and as a process team coach. I also taught CQE refresher classes from 1990 to 1995 to my colleagues at AT&T. More than 300 colleagues attended my training; 200 went on to take the CQE exam and 89 passed. I also assisted 300 AT&T colleagues in becoming members of ASQ. In 1993, I began serving as an adjunct professor teaching a variety of operations courses in Chicago-area business schools. Then, in 2000, I began to help organizaMANU K. VORA is the founder of Business Excellence Inc. in Naperville, IL. He earned a doctorate in chemical engineering from the Illinois Institute of Technology in Chicago. He has authored, co-authored, and edited numerous papers and a book on quality management and business excellence. He is a fellow of ASQ, an ASQ-certied quality engineer, and the recipient of the ASQ Distinguished Service Medal, the Grant Medal, the Hutchens Medal and the Lancaster Medal.

improving the ASQ certication process, and spearheading the rst investing in quality capital campaign where we raised $1.75 million to nd a permanent place for ASQs headquarters. I would highly recommend organizations to encourage their employees to join ASQ. The ongoing benets of joining ASQ are priceless. I also would advise other professionals to volunteer for any of the numerous opportunities available within ASQ and continue sharpening their personal leadership skills. I will continue to mentor my fellow ASQ members and add value to their professional journeys. QP

January 2014 QP 47

CAREER CORNER

BY JOSEPH D. CONKLIN

Putting Pen to Paper


Task management tips for the digitally unhip
I HAVE a running challenge with myself: I try to be part of the digital age without being enslaved by it. Im comfortable with PCs and laptops, and I am part of the Facebook and LinkedIn scenes. My organization uses Microsoft Outlook for email and scheduling meetings. But I dont do Twitter or blogs, and I still keep my landline in case of cell phone tower outages. And Im still not used to the idea of phones that double as cameras. I am part enough of the Internet age to have only a dim memory of what it was like to organize an ofce before early technology supporter Al Gore and a few other talented people changed our world forever. When it comes to managing my tasks, I still make do with pen and paper. In the course of my career, I have seen task management approaches that rely on complicated logs or electronic aids. They usually strike me as a solution in search of a problem. If my job required extensive outside travel or communication with the general public, I suspect digital time and task management would loom larger. Currently, I have ve major responsibilities at work: 1. Reliability ofce liaison: I am one of several statisticians who code and update the programs used by the reliability ofce to evaluate new designs. 2. Interofce strategy meeting representative: For my department, I serve on the steering committee that oversees our divisions strategic plan. 3. Database management team member: I help a group charged with managing product performance data provided by eld reports and outside labs. 4. Advisor on shared computing committee: I assess the possible impact of changes on my organizations ability to provide statistical services during IT resources consolidation. 5. Conference postings and papers coordinator: I arrange the submission of abstracts, dress rehearsals and internal department review of papers for presentation at professional conferences. If your job resembles mine, I can offer you a network outage-proof routine that I carry out at the end of the workweek to assess my progress and plan ahead. First, I create a list of current projects and the associated signicant milestones (see Table 1 for a sample). The milestones under each project reect deadlines 30-to60 days ahead. Generally, my project lists remain current over the following two to four weeks. Milestones come from four sources: 1. The departments calendar of recurring services it provides at the same time each year. 2. Updates to the departments master list of project requests from other ofces. 3. Announcements in my supervisors weekly staff meetings. 4. All-hands-on-deck meetings called for special or urgent situations. These four sources ensure my project list is always aligned with organizational goals. To ensure I set appropriate timelines and milestones, I also take regular notes in meetings and seek frequent clarication from my supervisor. After the project list is in place, I nish Friday afternoon by preparing the task list for the upcoming week. It consists of two sections: one for meetings and another for the major to dos. I leave space on the sheet to track issues during the course of the current week and to drive the contents of the following weeks task list. The task list is a combination of my independent activities and things I must do to prepare for meetings. The tasks are prioritized by deadline; tasks without a due date that week fall to the bottom of the list. I sort tasks that do not have a deadline by order of importance. The lowest priority items settle to the bottom. Table 2 is an example of what a typical task list looks like on Friday afternoon after its drafted. Table 3 shows what it might look by the end of the following Friday.

Current project list / TABLE 1


1. Reliability ofce liaison. Update modeling software. Design statistical protocols for new product testing. Evaluate data storage features of new stress testing equipment. 2. Interofce strategy meeting. Arrange trips for outside consultants. Complete award nominations for outstanding staff contributions. Write department part of next slide presentation. 3. Database management team. Archives and records meeting. Contractor qualication audits. 4. Shared computing task force. Security testing protocol. Budget and schedule review meetings. 5. Conference postings and papers. Internal search utility for papers. ASQ conference paper submissions. Outside source permissions. Reviews for proceedings publication.

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Task list (start of week) / TABLE 2


Tasks for Monday MM/DD/YYYY to Friday MM/DD/YYYY Meetings Day Mon Mon Mon Mon Tues Wed Wed Wed Thu Fri 10:00 11:00 12:00 1:00 9:00 1:00 Conference Lunch room Training room Staff meeting. Host professional society lunch. Dry runs for ASQ conference. Time 8:00 8:45 11:00 11:30 12:00 12:30 1:30 3:30 Location AB-003 My ofce B branch My ofce Subject Computing task force budget review. Next training session for new hire. Slides for strategic planning meeting. Keep open to possibly escort new contractors.

To do Conrm whether I have to escort new contractors Monday. Inputs to supervisor for weekly department accomplishments. Finish slides for strategic planning meeting. Finish slides for Wednesday lunch. Conrm speakers for Wednesday dress rehearsal. Test new statistical program for handling multiple stress sources. Select latest eld reports for archiving in database. Remind reliability ofce to run annual updates for modeling programs. Ask IT for update on new search utility for online agency reports.

Task list (end of week) / TABLE 3


Tasks for Monday MM/DD/YYYY to Friday MM/DD/YYYY Meetings Day Mon Mon Mon Mon Mon Tues Wed Wed Wed Thu Fri Fri 10:00 11:00 12:00 1:00 9:00 1:00 8:00 12:00 12:30 2:30 3:30 3:30 Conference Lunch room Training room My ofce My ofce My ofce Staff meeting. Bring dates for vacation to next meeting. Host professional society lunch. Write thank you to speaker. Dry runs for ASQ conference. Send papers to front ofce. Test new program for multiple stress sources. Select latest eld reports for archiving in database. Fill in for boss on conference call for contractor audit. Time 8:00 8:45 11:00 11:30 12:00 12:30 12:00 12:30 1:30 3:30 Location AB-003 My ofce B branch My ofce My ofce Subject Computing task force budget. Need ideas to reduce budget. Next training session for new hire. Needs intro to analysis of variance. Slides for strategic planning meeting. Moved to next week. Finish slides for Wednesday lunch. Keep open to possibly escort new contractors. Canceled.
To do Conrm whether I have to escort new contractors Monday. Not applicable. Inputs to supervisor for weekly department accomplishments. Edit for next performance review. Finish slides for strategic planning meeting. Reschedule for next week. Finish slides for Wednesday lunch. Move to slot for canceled strategic planning meeting. Conrm speakers for Wednesday dress rehearsal. Papers ready for front ofce approval. Test new statistical program for handling multiple stress sources. Schedule for Thursday morning. Select latest eld reports for archiving in database. Schedule for early Friday afternoon. Remind reliability ofce to run annual updates for modeling programs. Carry over to next week. Ask IT for update on new search utility for online agency reports. Carry over to next week.

The notes shown in Table 3, in conjunction with the project list, help me plan the following week. I always save the task lists from the previous month and review them when updating my project list at the start of a new month. They occasionally provide warning signs of pending problems to bring to managements attention. As an added bonus, the records

provided by the task lists are invaluable during performance reviews. The lists help me remember all of my signicant accomplishments throughout the year and allow me to contribute meaningfully to decisions about next years goals. For example, a prospective reorganization may cause my department to have more interofce visits in its future.

That could require the use of additional electronic communication and scheduling aids. I noted on my handwritten list to sign up for trainingif I can only remember if its for the phone that takes pictures or the camera that makes calls. QP

CONKLIN ON CAREERS

Joseph D. Conklin is a long-time QP contributor. Find his previous columns in the Career Corner archive under the Departments and Columns tab at www. qualityprogress.com.

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

January 2014 QP 49

INNOVATION IMPERATIVE

BY PETER MERRILL

The New Revolution


3-D printing is changing manufacturing and the world as we know it
WITH THE THEME of this QP issue being technology, it was an easy decision to focus the Innovation Imperative column on 3-D printing. It is one of the most exciting new technologies since the transistor of the last century, and since the steam engine two centuries before that. But in this column, I want to focus less on the technology and more on the possibilities the technology brings. The technology is changing at an amazing pace. If I had written this column two years ago, the facts and the data I quote would have been very different. Two years from now, this column will likely be obsolete. So what are the possibilities? Imagine you are doing a job around the house and youre missing a bolt or screw of the correct thread, or even a wrench of the right size. You waste an hour hunting for it, thenin frustrationdrive to the store to buy what you need. Ten years from now, you will go to your computer, or more likely your handheld device, input the data for the item you The innovator looks for unmet needs, and there are so many out there. The innovator asks: Where do people waste time, and where are they having trouble getting things done? Whether it is nding the right nuts and bolts for a household task, nding a new pair of shoes of the right style, color and t, or at the extreme, waiting for surgery or an organ transplant, 3-D printing will at some time in the not-too-distant future provide answers to frustrating tasks. Its not there yet, but at the present pace of development, its getting closer every day.

Technological basics
Many readers are likely already familiar with 3-D printing technology, so I will discuss it only briey. It combines the technologies of inkjet printing, computer-aided design (CAD) software and advanced materials. Youve already seen it in movies. Remember Mission Impossible III when Ethan Hunt (Tom Cruise) and his team build a mask he will wear you need the CAD software, which has become well-developed in recent years. You need hardwaresimilar to your desktop printer. Finally, you need material, which is where the challenges are. The rst step in all 3-D printing processes is for software to identify crosssections through the item to be built and calculate how each layer must be created. The machine builds up the item a layer at a time by applying a thin layer of resin or by using a laser to melt metal powder.
3-D PRINTING is a process that makes a solid object of virtually any shape from a digital model.

3-D printing will at some time in the not-too-distant future provide answers to frustrating tasks.
need, press print and your 3-D printer which will be the size of your present desktop 2-D printerwill make what you need while you have a cup of coffee. This is not something from science ction writer Isaac Asimov1this is the real world. to impersonate the evil villain? You see the mask being built in a series of layers using a computer image and injecting a material onto a base where the material solidies. The computer image is replicated on the mask. Conceptually, thats all it is. Practically,

The material hardens in the pattern of the cross-section. Its just like in the Mission Impossible example. The tray on which the item sits drops about a millimeter or less, a new layer of resin is applied and the process repeats. A variation on this operates like inkjet

50 QP www.qualityprogress.com

printing. Printing heads in the machine apply a liquid binder onto a bed of powder. Color is applied at the same time. Traditionally, manufacturing components have been made using the techniques of a sculptordrilling, milling and grinding to work a piece of metal. 3-D printing uses the techniques of a potter building from clay up to the nished product. That is why it is often called additive manufacturing. Development of advanced materials has been slow due to excessive secrecy and lack of collaboration. My organization pioneered C-ber manufacture from acrylic ber 50 years ago, but the current method of C-ber fabrication is hugely archaic. The technology of synthetic ber manufacture was developed many years ago, and I spent my early R&D days as a chemical engineer in that eld. Modern inkjet technology has evolved from that. The great advances in 3-D printing have been in software development, which is largely due to open-source development and good collaboration. mass customization becomes a reality. A batch size of one costs the same as 100 or 1,000. This attribute has huge benets at the R&D stage of innovation. The eternal nightmare of the scale-up from development to production is now eliminated. It also enables the development team to trial alternatives at low costs. For example, the shoe manufacturer Timberland developed a new shoe sole in 90 minutes for $35, instead of spending a week and $1,200. Some of the other possibilities 3-D
2

printing presents affect our everyday lives quite dramatically. Hospitals can make custom-made metallic and plastic implants for surgical use. There is R&D work taking place that involves human cells being used in the 3-D printer to produce a replacement body part. Researchers are currently working on creating blood vessels, but imagine if ears, liver and kidneys built
A 3-D PRINTED piece in an advanced manufacturing laboratory. 3-D printing offers several benets in manufacturing, including reduced cycle time and cost, and enhanced efciency.

from living tissue also could be created. This would mean eliminating the waiting time for donors. A university in China working on this endeavor predicts the production of fully functional printed organs could be reality in the next 10 to 20 years.3 A university in Belgium already reported that it printed a jawbone for an 83-year-old woman, it was implanted, and the woman is now able to chew and speak with the new jawbone.4

Serious downsides
The dark side to all of this is that less desirable items also can be printed. One organization has already reported it built

Quality benets
3-D printing has many attributes that appeal to the quality professional, the rst being cycle-time reduction. You make an item at the point where it will be used. You dont need a mold, which is the high-cost item in plastic fabrication. Material efciency is much higheryou only use what you need. Most dramatically, economies of scale evaporate and
3-D PRINTING is often called additive manufacturing because material is built up to create the nished product.

January 2014 QP 51

INNOVATION IMPERATIVE
a plastic gun and made design blueprints freely available on the internet.5,6 This means anyone with a 3-D printer could make a gun, use it for criminal purposes and dispose of it so that the gun is untraceable. Broaden your thinking and this becomes the perfect answer for the terrorist, drug lord and gang leader. Broaden further and imagine the production of nuclear weapons in anonymous locations. This is serious stuff. If you dont believe me on these issues, there is a good video on YouTube about 3-D printing that I recommend you watch.7 Even if you do believe me, watch it anyway. The video is from the 16 x 9 news program and shows a young man interviewed shortly after the mass shooting at Sandy Hook Elementary School in Newtown, CT, in December 2012. He smiles happily and explains how he is working on making a gun using 3-D printing, and says he is doing it to make a political statement. Its chilling to watch, and its a reminder that it will be just as difcult to control the making of weapons using 3-D printing as it is to control free downloading of music, movies and software. The issue of Internet Protocol (IP) addresses is huge and relates to this discussion, but is outside the scope of this column. quite basic, but it shows where things are headed. QP
REFERENCES AND NOTES
1. Isaac Asimov, Wikipedia, http://en.wikipedia.org/wiki/ isaac_asimov. 2. 3D Systems, The Timberland Company, www.zcorp.com/ en/Company/Customers/Case-Studies/The-TimberlandCompany/spage.aspx (case sensitive). 3. Helen Morgan, Chinese Scientists Successfully Produce a Living Kidney Using a 3-D Printer, Inhabitat, Sept. 9, 2013, http://inhabitat.com/incredible-medical-advancement-asscientists-produce-living-kidney-using-3d-printer. 4. Paul Marks, 3-D Printer Provides Woman With a Brand New Jaw, New Scientist One Per Cent blog, Feb. 6, 2012, www. newscientist.com/blogs/onepercent/2012/02/3d-printerprovides-woman-with.html. 5. Mario Diaz, Guns Printed With 3-D printers are Latest Security Scare After Blueprints Hit the Internet, Pix 11, May 6, 2013, http://pix11.com/2013/05/06/guns-printedwith-3d-printers-are-latest-security-scare/#axzz2lmjaP9nH (case sensitive). 6. The blueprints were downloaded more than 100,000 times before being removed at the order of the U.S. government. For more information, visit: www.cbsnews.com/news/3dprinted-gun-blueprints-pulled-from-internet-at-request-ofstate-department. 7. 16 x 9, 3-D Printing: Make Anything You Want, http://www. youtube.com/watch?v=G0EJmBoLq-g (case sensitive). 8. Print Me a Stradivarius, Economist, Feb. 10, 2011, www. economist.com/node/18114327. 9. Mark Hachman Microsoft Debuts 3-D Printing App for Windows 8.1, PC World, Nov. 15, 2013, www.pcworld.com/ article/2064062/microsoft-debuts-3d-printing-app-forwindows-8-1.html. 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.

Looking ahead
The current slow speed of 3-D printers limits its use in mass production, although you can expect that to change. But even as efciency and function improve, that is not where its benets will be most feltand thats not the point of the technology. A couple of years ago, a great article was published in the Economist headlined, Print Me a Stradivarius.8 It explained how the industrial revolution of the 18th century and the arrival of mass production changed economics and societies through economies of scale. It goes on to explain that 3-D printing will do the opposite. The article provides data and costs on 3-D printing. In just two years, machines that cost $20,000 will cost less than $1,000. So, do you want to get started? Retail stores are supplying 3-D printers and you can download software with 30,000 3-D designs on it, or if you still prefer, you can buy the DVD. Just days before I wrote this column, Microsoft released a 3-D printing app for Windows 8.1.9 Its

!
QP editors have nalized the 2014 editorial calendar, and now were looking for authors to write on these topics:

April
May June July August

Food and product safety Teams and leadership Supply chain Steer your career: expert advice Culture

September October November December

Standards and auditing Certication Global quality Salary survey

If you want to write for a specic issue, please submit your article at least three to six months before the issue date to allow enough time for the article to be reviewed, revised and scheduled. But if you miss that deadline, dont worry. Send the article anyway. All accepted articles will be published. Visit www.qualityprogress.com and click on Author Guidelines at the bottom of the page for more details.
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QUALITY PROGRESS

STATISTICS ROUNDTABLE

BY LYNNE B. HARE

Assessing Analytical Equipment Accuracy


Avoiding the pitfalls of automated systems
MUCH INK AND TRAINING time have been devoted to measurement systems analysis (MSA)the adopted child of Six Sigmaand other statistical training programs that continue to add great value through improvements in quality and productivity. MSA embraces sample-to-sample (or incident-to-incident variation) together with accuracy and precision. Precision, in turn, is often thought to consist of repeatability and reproducibility. Repeatability is the variation from repeated measures of the same sample by the same operator, while reproducibility is variation brought about by operator-to-operator differences and the failure of differences among samples to be the same from operator to operator. See Figure 1. Most impactful quality education programs cover the precision portion of MSA by teaching gauge repeatability and reproducibility, and several statistical software packages contain special pointand-click features for combined tabular and graphical analyses of data stemming from these studies. Carried out properly, they provide great value by isolating and quantifying major sources of process variation. The portion of MSA that seems to get less attention is accuracy. This could be because its easy to assume that an instrument is accurate, or you think it is best to take the equipment vendor at his word, or it is difcult and time consuming to assess accuracy, or for a variety of other reasons. of its knowns (K) at three levels. It provides assessments (A) for each of the three. Table 1 shows an example. Next, it calculates a regression equation relating the assessments to the knowns. With these data come the slope and intercept estimates of the least squares t together with a correlation coefcient. The slope is 0.9040, the intercept is 0.0211 and the correlation coefcient is 0.9997. The equation relating assessment to known is: A = 0.0211 + 0.9040K (equation one). In addition, we get predictions at each known observation, the difference between the predicted and the observed, and that difference expressed as a percentage of the corresponding known. As a bonus, there is a printer plot showing each of the three plotted observations.

MSA hierarchy of variation / FIGURE 1


Total variation

Example
A new reason, offered to me during a consulting session, was that the equipment contained a black box routine, meaning one with a computer algorithm that is unknown to the user used for self-calibration. What could possibly go wrong?

Transformations are available, apparently, but the default is linear/linear, presumably linear in both K and A, with the suggestion that some other transformations are available to the user. Also, you are told that this is a linear regression data reduction, so maybe there are other model forms available. You would have to read the manual to nd out. Does anyone read the manual anymore? You can check, too, but I found that I agreed closely with the estimates of intercept, slope and correlation, all assuming a linear model. See Table 2. Incidentally, I was delighted to see the plot of the data. It agrees with my advice: Always, always, alwayswithout exceptionplot the data, and look at the plot. The question is how best to use the

Sample to sample

Measurement system variation

Accuracy

Precision

Repeatability

Reproducibility

I thought, so I asked to take a closer look. As part of its morning

Operator

Operator by sample

exercises, the equipments computer requests submission

MSA = measurement systems analysis

January 2014 QP 53

STATISTICS ROUNDTABLE
plotted data and the slope, intercept and correlation estimates to tell if you should be satised with the accuracy of the device. Granted, from the plot, the data appear to follow a straight line, and the fact that the slope is close to one suggests a sensitivity of assessment to known, while the intercept being near zero conforms to intuition about the relationship. But how far from one must the slope be, and how far from zero must the intercept be, to cause concern? Perhaps the software author tried to help answer these questions by listing the correlation coefcient. The Pearson correlation coefcient measures proximity to linearity, so the closer to one, the greater the assurance of no curvature. But again, where do you draw the line? If the correlation coefcient were 0.90 instead of 0.9997, should we worry about curvature? Some assistance may come from examining condence intervals about the estimates. As can be seen from Table 2, condence bounds about the intercept and slope estimates appear to support the anticipated values of zero and one, respectively. But you are unable to produce a condence interval about the correlation coefcient with only three observations. The likely intent of the black box output is for the analyst to use the regression line equation 1 in reverse to arrive at the calibrated or adjusted known value from the assessed value. Indeed, in this case, this was the practice. The reverse equation is: K = (A 0.0211) / 0.9040 (equation two). How good is the estimate
Assessment

Assessment and known calibration data / FIGURE 2


0.5 0.4 0.3 0.2 0.1 0 0 0.1 0.2 0.3 Known 0.4 0.5

of the known, given the assessment? Inverse prediction shows that the 95% condence limits for the knowngiven an assessed value of 0.2, for exampleare 0.0678 and 0.3170. This interval occupies almost 50% of the known data range, so I wonder about the worth of the estimate to the analyst and the ultimate customer of the result. What can be done to lower the range of uncertainty? Run more knowns. It turns out that say from 0.05 to 0.50 in steps of 0.05, and if the same relationship as in equation one were found, the range of uncertainty would be narrowed to roughly 8% of the data range. if 10 knowns were submitted,

Expanded assessment and known calibration data / FIGURE 3


0.5 0.4 Assessment 0.3 0.2 0.1 0 0 0.1 0.2 0.3 Known 0.4 0.5 Assessment vs. known

A better approach
But wait. Weve gotten way ahead of ourselves. Look back at Table 2 and Figure 2. Is there anything to persuade us that the intercept and slope of the regression of assessment on known are different from zero and one, respectively? No. Then why should you adjust the assessment values you read? There is nothing to suggest anything unusual in

the direct readings. Therefore, the inverse regression calculations are unnecessary. Moreover, their use results in increased variation of the outcome. How might you do better to test and assure accuracy? For starters, it may not be necessary to calibrate with every analytical run. You should experiment

Analytical equipment calibration data / TABLE 1


Observation 1 2 3 Known (K) 0.05 0.2 0.5 Assessment (A) 0.070 0.196 0.475

Regression estimates with condence intervals / TABLE 2


95% Condence Statistic Intercept Slope Correlation coefcient Estimate 0.0202 0.9042 0.9997 Lower bound 0.0674 0.6213 Upper bound 0.1093 1.1872

No estimate

54 QP www.qualityprogress.com

Expanded analytical equipment calibration data / TABLE 3


Observation 1 2 3 4 5 6 7 8 9 10 Known (K) 0.05 0.1 0.15 0.2 0.25 0.3 0.35 0.4 0.45 0.5 Assessment (A) 0.043 0.102 0.163 0.207 0.255 0.298 0.344 0.399 0.452 0.484

Coefcients of linear and second order models with standard errors and 95% condence limits / TABLE 4
Model Second order model (equation 3) First order model (equation 1) Term Intercept Known K2 Intercept Known Estimate 0.012 0.971 0.192 0.008 0.971 Standard error 0.005 0.013 0.104 0.005 0.015 Lower 95% 0.001 0.939 0.439 0.003 0.936 Upper 95% 0.023 1.002 0.055 0.019 1.005

4. Notice that in the second order model, the K2 terms 95% condence interval contains zero. This suggests there is no real evidence of curvature, and

Now, in defense of those who produce and sell analytical equipment and its accompanying black box software, you must remember that both workload and speed of results are of the essence. Technicians cannot be expected to spend hours on calibration. So the mornings scanty exercise of only three calibration points might not be such a bad thing as a matter of routine. It might portend disaster, but I couldnt recommend it as routine or as the basis for inverse prediction. Rather, there should be a more extensive calibration study involving more levels of the known. Automated equipment or not, and black box software or not, the point is that a plan for the routine assessment and maintenance of accuracy is essential. Without it, youre just busy with numbers. QP
ACKNOWLEDGMENT
The author thanks J. Richard Trout for his helpful improvement ideas on this column.

to learn how long the equipment holds its calibration in the face of repeated use. Secondly, you should give yourself a ghting chance at nding departures from expectation by running about 10 knowns, instead of only three, that span the range of routine operation. Examine the slope and intercept together with their respective condence intervals. It is OK to look at the correlation coefcient to get a rough idea of linearity, but you might be better off tting a second order modelafter plotting the data, of courseto learn if there is signicant curvature in the relationship between assessment and known. Table 3 shows how the expanded data set might appear, and Figure 3 (p. 54) shows a plot of the data. The plot pleads for a linear t, but just to satisfy your curiosity, you can t a second order term as in the model: A = b0 + b1K + b2K (equation three),
2

the second order model is not a good t for these data. Instead, you should look at the rst order models statistics in the lower half of Table 4. There, you see that the condence intervals contain the anticipated zero intercept and slope of one. The correlation coefcients for both models are very close to one, but as stated earlier, they dont really provide the best information for linearity in this case.

Misleading software
You might speculate that the equipment manufacturer has two departments developing the analytical machinery. One department produces a machine that works very hard to provide highly accurate results, and the other department creates parallel software to check on the accuracy and guide the analyst toward correction when the accuracy doesnt match expectations. This is all well intended, but the departments dont know that they are sometimes working at cross purposes. Even when the machine gets results that are well within expectation, given the inherent variation, the software tells the analyst to modify them.

in which: b0 represents the intercept. b1 represents the linear slope. b2 represents the second order coefcient, which is a measure of curvature. Relevant statistics are shown in Table

LYNNE B. HARE is a statistical consultant. He holds a doctorate in statistics from Rutgers University in New Brunswick, NJ. He is past chairman of the ASQ Statistics Division and a fellow of both ASQ and the American Statistical Association.

January 2014 QP 55

STANDARDS OUTLOOK

BY DALE K. GORDON

Common Ground
Ensuring proper assessment of standards compliance globally
I RECENTLY returned from the International Accreditation Forum (IAF) annual meeting in Seoul, South Korea. There, IAF members coordinate activities, agree on cooperation methods and work in subcommittees and technical committees to establish requirements, policies and rules of operation for the global accreditation of just about anything. The IAF is dened as:
the world association of conformity assessment accreditation bodies and other bodies interested in conformity assessment in the elds of management systems, products, services, personnel and other similar programs of conformity assessment. Its primary function is to develop a single worldwide program of conformity assessment which reduces risk for business and its customers by assuring them that accredited certicates may be relied upon. Accreditation assures users of the competence and impartiality of the body accredited.
1

tions conforming to recognized standards. Accreditation by a recognized AB ensures the impartiality and competence of the CB, and fosters condence and acceptance of the CBs certications by end users in public and private sectors. This is essential so an organization can be condent in the certication it obtains to demonstrate compliance to a standard. Accreditation ensures the CB is competent and has procedures, processes and personnel in place to manage the certication process under consistent and agreed on rules from the ABs.

In other cases, such as in the United States, ABs are independent organizations that collect fees for the accreditation service but follow all of the MLA requirements. This is not to say that there are no requirements for the issuance of certications and the determination of the competency of personnel and the processes to be performed. In fact, there are existing International Organization for Standardization (ISO) standards that serve this purpose, many of which have been promulgated by IAF in cooperation with the ISO Committee on Conformity Assessment (CASCO), which works on standards such as the ISO 17000 series.2 CASCO is comprised of 75 countries that vote and publish the current standards. These standards include requirements for ABs accreditation of CBs (ISO 17011), requirements for CBs certication of management systems (ISO 17021), requirements for the duration of management systems audits (ISO 17023) and requirements for CBs certication of products, processes and services (ISO 17065). Some of these standards replace what were known originally in the certication process as Guides 62 and 65, as well as other ISO guidance on conformity assessment. IAF, however, is the glue that holds the system together. There are implementation issues and variables in these standards that require clarication for consistency across the globe. For this reason, IAF issues various mandatory documents (MD) for its member organizations to assist in lling in gaps or addressing implementation issues. The MDs are put forward by technical committees and voted on by IAF members. These MDs include interpretative requirements. Examples include:

Auditing the auditors


Where, however, is the assurance that there is agreement across ABs on what these rules, processes and procedures should be so certications can cross borders and be accepted globally? This is important in facilitating commerce and assuring customers the organizations and personnel they do business withas well as the products they usecomply with standards as intended. In simple terms, who is auditing the auditors? Beyond the accreditation of the CBs, who is overseeing the ABs? This is where the IAF comes in. The IAF consists of ABs who agree to abide by a certain set of requirements for themselves and the CBs they oversee. Participation in the IAF acts as an agreement and facilitates a peer-review process to ensure the ABs follow the established rules. This is accomplished through the multilateral agreement (MLA), which each of the member ABs signs. There are 63 countries and 70 ABs that sign the MLA. Some ABs are government entities that have the sole authority to accredit CBs for the issuance of certications.

Most of us in the standards writing, compliance and implementation process recognize the fairly well-established schemes that are used across various standards, such as ISO 9001 or similar systems for aerospace, automotive, the environment, forestry, food safety, healthcare, medical devices, security and telecommunications. Additionally, we recognize the certication processes that are in place for these standards to allow for global recognition of compliance. These processes are facilitated through the use of certication bodies (CB) that are accredited by accreditation bodies (AB). The role of the ABs, for the most part, is to assess and accredit CBs, ensuring they demonstrate competence to audit and certify organiza-

56 QP www.qualityprogress.com

IAF MD 1:2007Certication of multiple sites based on sampling, which states that all clauses of ISO/IEC 17021:2006 continue to apply and do not supersede any of the requirements in that standard.
3

stakeholder groups that seek to facilitate global trade through the acceptance of accredited certicates of conformity. It also supports developing countries in implementing ABs and certication programs to enable free trade with other developed economies by assuring condence in the organizations that hold those approvals.

standards that directly apply to certain types of products are gaining much attention and interest as global supply chains get longer and requirements for safe and quality products become more demanding. The value provided by auditing the auditors is needed and welcome to ensure condence in the certicates organizations obtain to show compliance to standards. Its important for consumers to be able to easily differentiate accredited certicates from something an organization may have bought off the internet or was issued in exchange for a simple paymentwhich has no value to the consumer or user at all. QP
REFERENCES
1. International Accreditation Forum (IAF), www.iaf.nu. 2. International Organization for Standardization, CASCO, www.iso.org/iso/home/about/conformity-assessment/ casco.htm. 3. IAF, IAF Mandatory Document for the Certication of Multiple Sites Based on Sampling, 2007, www.compad.com. au/cms/iaf/workstation/upFiles/351519.IAF-MD1-2007_ Certication_of_Multiple_Sites_Pub2.pdf (case sensitive). 4. IAF, IAF Mandatory Document for the Transfer of Accredited Certication of Management Systems, 2007, www. compad.com.au/cms/iafnu/workstation/upFiles/127162. IAF-MD2-2007_Transfer_of_Certication_Pub2.pdf (case sensitive). 5. IAF, IAF Mandatory Document for Advanced Surveillance and Recertication Procedures, 2008, www.compad.com. au/cms/iafnu/workstation/upFiles/847722.IAF-MD3-2008_ ASRP_Pub.pdf (case sensitive). 6. IAF, IAF Mandatory Document for Duration of Quality Management Systems and Environmental Management Systems Audits, 2013, www.compad.com.au/cms/iafnu/ workstation/upFiles/IAFMD52013QMSEMS_Audit_ DurationPub.pdf (case sensitive). 7. IAF, IAF Mandatory Document for the Application of ISO/ IEC 17011 in Medical Device Quality Management Systems (ISO 13485), 2011, www.compad.com.au/cms/iafnu/ workstation/upFiles/IAFMD82011ApplicationofISO17011 inMDQMSPub.pdf (case sensitive). 8. IAF, IAF Mandatory Document for Assessment of Certication Body Management of Competence in Accordance with ISO/IEC 17021:2011, 2013, www.compad.com.au/cms/ iafnu/workstation/upFiles/IAFMD102013CB_Competence. pdf (case sensitive).

IAF MD 2:2007Transfer of accredited certication of management systems, which is for the consistent application of clause 9.1.1 of ISO/IEC 17021. All clauses of ISO/IEC 17021 continue to apply. This document does not supersede any of the requirements in that standard.4 IAF MD 3:2008Advanced surveillance and recertication procedures, which provides normative criteria for advanced surveillance and recertication procedures for consistent application of clause 9.1.1 of ISO/IEC 17021 for determining subsequent adjustments to the audit program.5 IAF MD 5:2013Duration of quality management system (QMS) and environmental management system audits, which provides mandatory provisions and guidance for conformity assessment bodies to determine the audit duration for stage one and stage two initial audits, surveillance audits and recertication audits.
6

Crossing borders
In this day and age of interlinked global sourcing of food, pharmaceuticals and equipment for products such as aircrafts, automotives, medical devices and telecommunications devices, it becomes prohibitively expensive for all organizations or users of the global supply chain to independently monitor capability and compliance. Think about some recent headlines about improper manufacture of pharmaceuticals, or food issues from foreign or domestic sources of food. Even the recent tragedies related to working conditions in places such as Bangladesh are the types of matters that could ultimately fall under the purview of an accreditation program for standards on workplace safety and working conditions. The goal is to provide users and stakeholders a level of condence in certication processesa guarantee that organizations with certicates from accredited CBs have been through specied audits conducted by competent personnel and have demonstrated compliance to the standards to which theyre certied. Accreditation does not replace regulatory or governmental powers, but it can, in fact, help reduce the regulations or laws by implementing a self-governance approach by like-minded organizations in similar types of industries or service groups. This will benet all the stakeholders and consumers of the products or services. While ISO 9001, the current QMS standard, is the most widely used approach for accredited certication-type programs, certication to specic management system

IAF MD 8:2011Application of ISO/ IEC 17011 in medical device quality management systems, which enables ABs to harmonize their application of ISO/IEC 17011 for the accreditation of bodies providing audit and certication to ISO 13485.7 IAF MD 10:2013Assessment of certication body management of competence in accordance with ISO 17021, which provides a harmonized approach on how ABs assess a CBs management of competence per ISO 17021.
8

These are just examples of the outputs of IAF. There are also policy documents, procedures and informative documents. IAF brings togetheron a worldwide basispartner ABs and representatives of

DALE K. GORDON is director of supplier quality for Aerojet Rocketdyne/ Gen Corp., in Sacramento, CA. He is an ASQ fellow, chair of the SAE Americas Aerospace Quality Standards Committee (G-14) and has served on many writing teams for the aerospace series of standards. Gordon earned a bachelors degree in industrial engineering from General Motors Institute (now Kettering University) in Flint, MI, and an MBA from Butler University in Indianapolis.

January 2014 QP 57

QPTOOLBOX
Blender
Concoa has introduced a blender that enables users to create custom-blended gas mixtures on site for industrial welding applications. The BlendMaster 657 series provides 0 to 25% blend adjustability for two-component gases. EquiBlend technology allows for full ow regardless of the mix or blend ratio. A pressure equalization system minimizes inlet pressure uctuations to stabilize the mix, broadening the inlet pressure range difference between the major and minor component gases. The BlendMaster is also compatible with a wide variety of cryogenic supply sources, such as liquid cans, micro-bulk and bulk gas supply systems. The low inlet pressure range allows for accurate mixing even while supply sources are lled. Call: 800-225-0473. Email: rgreen@concoa.com. onboard ampliers. Maximum safe load is 150% of rated capacity for moments and 300% of rated capacity for tensile forces. When properly installed on a conveyor system, the Model 411-106-10K provides real-time moving measurements of tensile forces, horizontal bending moments, vertical bending moments and twisting moments. Call: 586-739-4254. Visit: www.sensordata.com.

harsh environments. The high-resolution DFS2X incremental encoders are ideal for packaging, printing, roll diameter sensing and general manufacturing applications that require positional feedback or speed monitoring. These encoders can also be used to provide speed and direction input to both bar code and 3-D camera systems. Call: 952-829-4728. Email: tracie.manor@sick.com.

Wireless diagnostic system

SensorData Technologies model M411106-10K is a wireless diagnostic system designed to aid factory oor personnel in the real-time evaluation and predictive maintenance of conveyor systems, with remote data transmission capabilities of up to 750 ft.

Incremental encoder

Electrical tranducers

Sick has released the DFS2X line of programmable incremental encoders. These 16-bit encoders feature a compact, rugged mechanical design and a metal code disc that ts many applications. The DFS2X encoders offer shaft, blind hollow and through hollow versions in a The model M411-106-10K works by simultaneously measuring the tensile and bending forces experienced by a moving conveyor system. The system is comprised of a multi-axis sensor link with small 2-in. housing, as well as a shaft version with a 2-in. housing. In addition to its small size, the IP 65-rated metal design is resistant to shock and vibrations, which reduces down time and enables use in

American Aerospace Controls (AAC) has announced a line of high-reliability

58 QP www.qualityprogress.com

standard and custom electrical transducers for rail, heavy locomotive, high-speed train and light rapid-transit monitoring. AAC current transducers help rail and locomotive original equipment manufacturers and their associated design and test engineering personnel to meet stringent EN50155, EN50121 and MIL-STD-202 standards. Typical applications include: Locomotive and rail traction motor power systems management: AC and DC current transducers provide critical power systems management by monitoring the electric current and ground fault voltages used by these traction motors, while further detecting potential areas in which power losses might be occurring within the overall system. Train event recorders: Current transducers have been used to monitor the DC current feed to a railway systems black box within light rapid transit, high-speed rail and heavy locomotive applications to ensure the uninterrupted recording of onboard systems data for maximum safety. Rolling stock car electronic equipment monitoring: Current transducers provide effective electromagnetic interference protection of stock car electronic equipment, helping to prevent against premature electronic equipment failure. Call: 631-694-5100. Visit: www.a-a-c.com.

for mounting within larger control panels and DINrail applications. Original equipment manufacturers will appreciate the 880s compact, modular design featuring a smaller, removable indicator face. The 880 adapts to a broad spectrum of technologies, whether they require USB, RS-232 or basic Ethernet connections. The 880 can operate as a standalone controller, but also connects to a range of industrial networking protocols. Call: 715-434-5364. Visit: www.ricelake.com/880. velocity feedback, over-speed alarm limits, operating temperature, heartbeat counters, position presets, standstill detection and time, count up direction, internal diagnostics, operating time and encoder conguration details. Call: 805-562-1160. Visit: www.leinelinde.com.

Rotary encoder

Leine and Linde have introduced the model 862 with Probus DP, a version of a rotary encoder supporting condition monitoring systems. This allows machine users to better monitor and implement a predictive motion control system. It also gives a plant manager insight into the general health of the encoder, as well as specic failure information should such an event occur. Working in tandem with the traditional incremental output signals, the Probus communications supports

Weight indicator

Rice Lake Weighing Systems 880 Performance Series weight indicator is a compact digital weight display and controller

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Send your product description and photo to vellifson@asq.org.

January 2014 QP 59

QPREVIEWS
Quality Caring in Nursing and Health Systems: Implications for Clinicians, Educators, and Leaders
Joanne R. Duffy, Springer Publishing, 2013, 328 pp., $55 (second edition, book). This book is about nursing and patient care performed with quality and passion. It emphasizes the relationship skills necessary for providing quality care. In the foreword by Jody Gittel, it is stated that: Ironically, it is in the name of quality assurance and cost reduction that relationships are often put aside. The author of the book aims to address this situation. The text is intended for nursing students and nursing leadership positions looking for concrete ways to properly balance efciencies with relationships between healthcare providers and patients. It is clear that quality care requires such a balance. The book is well-organized with 12 chapters divided into three parts and nine useful appendixes. The part that is missing relates to measuring feeling cared for. It is covered very briey, providing some references, but leaves the impression that quality care can be delivered without proper measurement. Readers interested in healthcare qualityespecially nursing professionalswill nd the book very interesting to read. Ron S. Kenett KPA Ltd. Raanana, Israel

Implementing ISO/IEC 17025:2005: A Practical Guide


Bob Mehta, ASQ Quality Press, 2013, 224 pp., $49 member, $80 list (book). The benets of this book are readily apparent since the scope and importance of the standard are known to many around the world. The authors considerable experience and knowledge in this area are presented in a logical, useful and consistent format. He provides a list of questions at the end of each chapter which can assist auditors as well as serve as a tool for managers of calibration systems. The book is organized into two parts. The rst part covers management requirements and the second part covers technical requirements. The details are further built on a number of supporting features. Other supporting features include a preface, an epilogue, a bibliography, an index and a list of gures and tables. The gures and tables are unique for several reasons. Each gure or table provides an actual example of the format and detail that an auditor would look for and that a customer should expect. The organization of the book matches the sections of the standard, so the examples are also presented in that same order. Lastly, the author cites some additional links that provide more detail. Current and future auditors should study this book because it is easy to read, readily applicable to everyday use and handy for practitioners and administra-

tors. While the books subtitle should explicitly include, General Requirements for the Competence of Testing and Calibration Laboratories, this reviewer can nd no other issues or areas for improvement in this edition. Frank Pokrop CareFusion San Diego

Team Building: Proven Strategies for Improving Team Performance


W. Gibb Dyer Jr., Jeffrey H. Dyer and William G. Dyer, Jossey-Bass, 304 pp., $45 (fth edition, book). Team building has become a mainstay of organizational development literature. Now 36 years old, this fth edition is an updated and valuable resource for its intended audience: managers, team leaders, team members and consultants. Replete with diagnostic and remediation tools, the book is comprised of four parts. The rst introduces the authors Four Cs team development model (context, composition, competencies and change management) and its companion assessments. Basic assessments are provided in the book and more advanced team assessments can be purchased online. The books second part focuses on resolving specic team problems. Part three presents team building for specic team types. Finally, a short summary and discus-

60 QP www.qualityprogress.com

sion of future challenges concludes the book. If youre a senior manager, consultant, Black Belt or lead any type of team, you should read this book. Implementing the collective years of knowledge in this book will help you make your team more effective. James Kotterman Asset Acceptance Warren, MI

of the statistical tools in other cases. The FDA is encouraging organizations to embrace a quality approach within their manufacturing environments. There are 12 chapters in the book, ranging from the basics of process variation, basic concepts, graphical tools, process capability, hypothesis testing, regression analysis, design of experiments and statistical process control charts. While the examples and discussions are held to a level that is understandable, the author does assume readers have at least some prior experience or understanding of terms and formulas used in statistics. And since the discussions on the particular subjects are not in-depth, I challenge whether the reader will be able to discern whether they are using each of the tools as they were intended and not misinterpreting them. Readers may obtain a better understanding of some of the statistical tools used to control processes and be encouraged to study with a greater level of detail the statistical tools presented in the book. Those just using the book alone without other reference materials and training

could get a warning letter from the FDA. Wayne Sander Dove Quality Consulting Dousman, WI

RECENT RELEASES
ISO 9001:2008 Explained And Expanded: Making Your Quality Management System Sustainable
Charles A. Cianfrani and John E. Jack West, ASQ Quality Press, 2014, 176 pp., $30 member, $50 list (book).

Statistical Process Control for the FDA-Regulated Industry


Manuel E. Pea-Rodrguez, ASQ Quality Press, 2013, 204 pp., $54 member, $90 (book). The author states this book is aimed at engineers, analysts, technicians, managers, supervisors and all other professionals responsible for measuring and improving the quality of their processes. However, the book does not provide an intensive course in statistics. Instead, it is intended to be a how-to guide about the application of the many statistical tools available today for organizations regulated by the U.S. Food and Drug Administration (FDA). I do feel the author has accomplished this with this book, with some exceptions. There have been more than 190 warning letters issued by the FDA to organizations in the last 10 years in which the term statistical control has been used. There is concern about the lack of use of statistics in some cases and the misuse

Modular Kaizen: Continuous And Breakthrough Improvement


Grace L. Duffy, ASQ Quality Press, 2013, 224 pp., $36 member, $60 list (book).

The Process Improvement Handbook: A Blueprint for Managing Change and Increasing Organizational Performance
Tristan Boutros and Tim Purdie, McGrawHill Professional, 2014, 416 pp., $90 (book).

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TM January 2014 QP 63

ONE GOOD IDEA

BY JOHN G. SUEDBECK

Bucket List
Categorize and control your risk management audit data
ICH Q9 IS a U.S. Food and Drug Administration standard on quality risk management developed by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Quality Risk Management from Annex II provides guidance for managing risk and lists risk factors to help auditors dene the frequency and scope of audits.1 Auditors collect evidence during the audit process and sort evidence according to the appropriate risk factor to facilitate risk assessment mitigation planning. I like to think of the factors provided in ICH Q9 as risk buckets for sorting data. supplier evaluation, recalls, returns, complaints, deviations, out of specication results, internal audits, nonconformances, change control, validation, documentation, calibration and preventive maintenance, product testing criteria and nished goods release. Review for adequacy and compliance. Complexity of the site and distribution. Review general site information, pest control, holding and distribution controls and security. Complexity of the manufacturing process. Perform process mapping and trace the supply chain. Identify key steps in the process. Verify there are adequate controls in place for each key step. Identify and dene quality lters in place (a safeguard analysis that shows what risks are managed and how). Complexity of the product and its therapeutic signicance. In descending order of risk, review sterile nished products, nonsterile nished products, sterile Note that reasonable conclusions are based on evidence that is sufcient, reliable and relevant. Previously, I discussed the reliability of audit evidence in Solid Proof (June 2012).2 The following is an approach for determining the relevancy of audit evidence as it pertains to each of the risk factors in ICH Q9: Existing legal requirements. Review nondisclosure agreements, supply agreements and quality agreements. Overall compliance status and history of the organization or facility. Review regulatory status certications and customer audit history. Robustness of an organizations quality risk management activities. Verify controls are in place for training, active pharmaceutical ingredients (API), nonsterile APIs with special risk factors (such as isomerisim, polymorphism or a special risk of harmful impurities), labs and contract research organizations, nonsterile APIs, excipients, labels and product contact packaging. Also consider risk factors associated with solubility, fermentation, toxicity, synthesis, impurities, solvents, chemical activity, potency and particle size: Number and signicance of quality defects. This is the quality history review for the item or service. Consider the development history as well. Review recalls, returns, complaints, deviations, out of specication results, internal audit data, nonconformances and internal
REFERENCE AND NOTE
1. Access ICH Q9 at www.fda.gov/downloads/ Regulatoryinformation/Guidances/ucm128053.pdf (case sensitive). 2. John G. Suedbeck, Solid Proof, Quality Progress, June 2012, http://asq.org/quality-progress/2012/06/back-to-basics/ back-to-basics-solid-proof.html. JOHN G. SUEDBECK is a quality assurance specialist for Metrics Inc. in Greenville, NC. He earned a bachelors degree in analytical chemistry from Fayetteville State University in North Carolina. A senior member of ASQ, Suedbeck is an ASQ-certied quality manager, quality improvement associate and quality auditor.

customer surveys. Results of previous audits and inspections. List all evaluations and reevaluations. Include distributors because they are part of the pedigree (an audit trail that follows a drug from the time it is manufactured through the distribution system to a pharmacy). Major changes related to building, equipment, processes and key personnel. Review the organizations history and change notication records. Experience with the manufacturing of a product. This may include frequency, volume, number of batches and the percentage of the organization in the pharmaceutical industry. The robustness of their quality management system and the level of technology in use also may serve as evidence of their experience. Test results of ofcial laboratories. Review pass and release testing results and regulatory history. A plethora of evidence often is obtained from the audit process and it can become confusing trying to make sense of it all. The risk factors suggested in ICH Q9 provide a means of sorting the data into manageable buckets that can help your organization assess risk and manage it effectively. QP

64 QP www.qualityprogress.com

2014 LEAN AND SIX SIGMA CONFERENCE


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