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The Ishikawa

Putting Best Practices to Work

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Small Business Challenge

A sidebar for this month’s cover story (“Keep Calm and Prepare for ISO 9001:2015,” pp. 18-28) examines the resources that small organizations can use to help with the transition to ISO 9001:2015.

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Keep Calm and Prepare for ISO 9001:2015

Standards experts provide basic analyses and map out five key changes included in ISO 9001:2015 to help make sense of what they mean, what your organization must do to meet the new requirements, and resources available to help you navigate the transition.

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A Hard Look at Software Quality

A pilot project proved how the ISO/IEC 25000 family of standards can be used to evaluate software quality and let developers better address maintenance issues.

by Moisés Rodríguez, Mario Piattini and Carlos Manuel Fernández AUDITING

Amazing Audits

A new approach that incorporates the Kano model can help you evaluate the performance of your quality audit programs. by Lance B. Coleman Sr.

HISTORY

Like Father, Like Son

A look back at the lasting contributions Ichiro Ishikawa and Kaoru Ishikawa made to total quality management and the world of quality.

by Gregory H. Watson

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30

38

Contents

46

KEEP

CALM

PREPARE FOR

ISO 9001:2015

18

38

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LogOn

Expert Answers

• Tips on initial ISO 9001 implementation.

• Choosing the right ISO 9001 consultant or registrar.

Keeping Current

• Dealing with drones.

Mr. Pareto Head

QP Toolbox

QP Reviews

DEPARTMENTS

Up Front

Measure for Measure

Updates needed to the occupation classification list.

Quality in the First Person

Learning early on to always do things right—not just when others are watching.

Career Corner

In job searches, do your homework on prospective employers.

Statistics Roundtable

Including nuisance factors during experimentation.

One Good Idea

Using fault data spectrums to check corrective actions.

BONUS

Back to Basics

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To learn more about the manuscript review process, helpful hints before submitting a manuscript and QP’s 2016 editorial planner, click on “Author Guidelines” at www. qualityprogress.com under “Tools and Resources.“

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ASQ’s Vision: By making quality a global priority, an organizational imperative and

a personal ethic, the American Society for Quality becomes the community for everyone who seeks quality technology, concepts or tools to improve themselves and their world.

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STRUCTURED DECISION MAKING

A new five-step process to evaluate and balance competing objectives.

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SUPPLIER DEVELOPMENT

How one energy company uses an automotive standard to assess and manage its suppliers.

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NEXT MONTH

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SPECIAL SECTION

ASQ’S STANDARDS AND

AUDITING GUIDE

UPFRONT

Stress Relief

Handy primer on the ISO 9001 revision

IT’S FINALLY HERE: the release of ISO 9001:2015. For months, many have been anx-iously awaiting this moment and all of the changes that come with it. And though the wait is over, now the clock starts ticking—organizations have three years to transition their quality management systems (QMS) to the new edition of the standard.

The transition raises many questions, such as: What is the new clause structure and why? What does it mean to understand your organization’s context? And how does your QMS address risk-based thinking?

Let us help. QP has been covering the revision process and providing information to help you prepare all along. With the standard’s release, we went all out to assemble the best “how-to” guide available. In “Keep Calm and Prepare for ISO 9001:2015,” p. 18, eight key experts weigh in on what you need to know about transitioning to the standard right now. Share this article with your colleagues, teams and bosses. The standard may just now be final, but this is when the real work begins.

This month’s Expert Answers department, p. 8, addresses some other important questions many have about getting started with ISO 9001 and hiring a consultant or registrar to transition to the standard.

Also, could your audit program stand to improve? Read “Amazing Audits,” p. 38, for some helpful tricks and tools to improve your audits using the Kano model. An evalu-ation form is provided to produce a ranking that is incorporated into the Kano model and used to improve internal audit performance.

I was listening to a radio segment this week about Chicago’s Air and Water Show and the newscasters were talking about what you couldn’t bring to the lakeside event, including alcohol and pop-up tents. New to the banned list this year: drones. Drones have the potential to offer great efficiencies and capabilities to organizations, yet as businesses wait for approvals, consumer use of drones speeds along, creating dan-gerous circumstances in the skies. In July, for instance, forest-firefighting aircraft in California were grounded because of drones flying above the blazes. Numerous pilots have reported drone sightings within airspace near airports. Regulation seems to be lagging. Read more about the scary situation in “Drone Dilemma” (p. 12). QP

Seiche Sanders Editor

EXECUTIVE EDITOR AND ASSOCIATE PUBLISHER Seiche Sanders ASSOCIATE EDITOR Mark Edmund ASSISTANT EDITOR Amanda Hankel MANUSCRIPT COORDINATOR Valerie Ellifson COPY EDITOR Susan E. Daniels CONTRIBUTING EDITOR Tyler Gaskill ART DIRECTOR Mary Uttech GRAPHIC DESIGNER Sandy Wyss PRODUCTION Cathy Milquet ADVERTISING PRODUCTION Barbara Mitrovic

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MEDIA SALES ADMINISTRATOR Kathy Thomas MARKETING ADMINISTRATOR Matt Meinholz EDITORIAL OFFICES Phone: 414-272-8575 Fax: 414-272-1734 ADVERTISING OFFICES Phone: 866-277-5666 ASQ ADMINISTRATION CEO William J. Troy Senior Leadership Andrew Baines Michael Barry Lynelle Korte Brian J. LeHouillier Lindsey Linder Laurel Nelson-Rowe

To promote discussion of issues in the field of quality and ensure coverage of all responsible points of view, Quality

Progress publishes articles representing conflicting and

minor-ity views. Opinions expressed are those of the authors and not necessarily of ASQ or Quality Progress. Use of the ASQ logo in advertisements does not necessarily constitute endorsement of that particular product or service by ASQ.

QUALITY PROGRESS

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QP • www.qualityprogress.com 6

LOG

ON

Helping suppliers improve

In response to “Back to Basics: Sufficient Evidence” (August 2015, p. 64): In my ca-reer as a computer components software quality engineer, I developed

and used an audit checklist to identify risks. This created a profile of the prospective suppliers’ strengths and weaknesses. We then worked with the chosen supplier to strengthen its weaknesses. We also put in place incoming inspections and testing as contingency measures to protect our organization from the supplier’s weaknesses.

The results from our inspections and testing were communicated back to the supplier to further drive its improvement efforts. The supplier, in turn, communi-cated its testing results to help identify any test correlation issues.

As our inspection and test data im-proved, we reduced, then dropped, our incoming inspections. We only monitored the final system test results and our customer feedback to verify acceptable quality and reliability. It was a lot of work, but it resulted in developing low-cost, high-quality suppliers.

Duane Briggs Lexington, SC

Plenty still unknown

“Open to Change” (July 2015, pp. 18-23) provided good but incomplete information on an unknown entity (ISO 9001:2015). The author has provided a little more light onto the shadowed outline of this critical subject. I don’t think we will really know what this new revision is until sometime

Seen&

Heard

Stay

Connected

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 Tyler Gaskill: @ASQ_Tyler [email protected] www.facebook.com/ groups/43461176682 www.linkedin.com/groups/quality-progress-magazine-asq-1878386 next year when an auditor finds that one

clause everyone else overlooked.

Tom Fessenden Cypress, TX

Clearing up

misunderstandings

In response to “Quality in the First Person: Substandard Training” (July 2015, pp. 46-47): Very good description of a (continuing) misapplication of the idea of standardization of quality processes. Even now, I am dismayed at the number of offerings to help people “avoid mistakes in interpretation” of the new version of the ISO 9001 standard. If the standard isn’t self-evidently clear, it isn’t written well.

Certification will require agreement with the auditor—so if you need any help at all, you should ask the auditor. Indepen-dent verifications are fine, but I still believe the market is the best indicator of quality success. If you satisfy the customers (with whatever your system is), you will do better than your competition.

Steven Cooke Charlotte, NC

Jargon included

In response to “Blank-Slate State” (May 2015, pp. 50-51): This matches my style exactly when creating a quality management system. The only thing I do differently is regarding “regulatory vomit.” I include this jargon so the person being audited will not be intimidated when the auditor uses it. For example, “Show me your procedure for product realization.”

Rick Paul Escondido, CA

Tune In

The latest episode of ASQ TV dives deep into root cause analysis, cov-ering how quality tools helped save a deteriorating national monument and the benefits of using the scien-tific method approach. Watch for two new episodes this month: one on standards and auditing (Sept. 8)

and another on ISO 9001:2015 certifica-tion (Sept. 29). Visit

http://videos.asq.

org to access the

full video library.

The Global Voice of QualityTM

Plus:

P

Restaurants ramp up table-side technology p. 10 Quality and social responsibility cross paths p. 26 Organizational restructuring to optimize innovation p. 14 With DoE p. 20 Driving Creativity Cultivating Creativity

Putting Best Practices to Work

QUALITY PROGRESS QU ALITY PROGRESS | AUGUST 2015 CREA TIVITY SP ARKS INNOV ATION VOLUME 48/NUMBER 8 www.qualityprogress.com | August 2015

September 2015 • QP 7

Q

P

PAST CHAIR

Stephen K. Hacker, Transformation Systems International, LLC

CHAIR

Cecilia Kimberlin, Kimberlin LLC (retired – Abbott) CHAIR-ELECT

Patricia La Londe, CareFusion TREASURER

Eric Hayler, BMW Manufacturing SECRETARY

William J. Troy, ASQ PARLIAMENTARIAN Sue Campbell, ASQ DIRECTORS

Donald Brecken, Ferris State University Heather L. Crawford, Apollo Endosurgery Raymond R. Crawford, Parsons Brinckerhoff Ha C. Dao, Emerson Climate Technologies Inc. Benito Flores, Universidad de Monterrey Julia K. Gabaldón, Quality New Mexico

Edwin G. Landauer, Clackamas Community College David B. Levy, Boyce Technologies, Inc.

Sylvester (Bud) M. Newton, Jr., Alcoa Daniella A. Picciotti, Bechtel Steven J. Schuelka, SJS Consulting Kush K. Shah, General Motors

James B. Shore, Quality Lean Solutions, LLC Jason Spiegler, Camstar Systems Inc. Joal Teitelbaum, Escritório de Engenharia G. Geoffrey Vining, Virginia Tech, Department of Statistics

QP EDITORIAL REVIEW BOARD Randy Brull, chair

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

Technical Reviewers

Andy Barnett, Matthew Barsalou, David Bonyuet, David Burger, Bernie Carpenter, L.N. Prabhu Chandrasekaran, Ken Cogan, Linda Cubalchini-Tra-vis, 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

QUICK POLL RESULTS

Each month at www.qualityprogress.com, visitors can take an informal survey. Here are the numbers from last month‘s Quick Poll:

What is your organization’s biggest barrier to creativity?

Visit www.qualityprogress.com for the latest question:

What gives you the most anxiety about implementing ISO 9001:2015? • Adopting risk-based thinking.

• Enhancing leadership’s role in quality. • Defining the context of your organization. • Dealing with documentation.

• Understanding the new clause structure.

QP

Quality

News

TODAY

Recent headlines from ASQ’s global news service

(All URLs case sensitive)

First 3-D-Printed Drug Approved by FDA

3-D printing allows the pill to deliver a higher dosage of medicine—up to 1,000 milli-grams—while being porous enough to dissolve quickly. These attributes can particularly benefit patients who have difficulty swallowing their medication and miss doses of treat-ment. (http://tinyurl.com/3ddrug)

New Breed of Software Engineers Join Automotive Industry

To cope with the software engineer shortage in the automotive industry, suppliers such as Visteon Corp. are turning to unconventional sources—such as the movie and video game industries—to recruit people. (http://tinyurl.com/autosofteng)

Videos feature ISO 9001:2015 experts

Most of the authors of this month’s cover story, “Keep Calm and Prepare for ISO 9001:2015” (pp. 18-28), appear on ASQ’s Standards Channel, where they discuss key changes in ISO 9001:2015 and offer advice for implementing it. Tune in to watch informational videos at videos.asq.org/asq-standards-channel.

Don’t be a victim

In his Standards Connection enewsletter article, “Avoiding Misinterpretation Quicksand,” expert John Guzik clears up potential misunderstandings in the new version of ISO 9001. Read the article at http://tinyurl.com/iso9001quicksand and subscribe to the enewsletter at asq.org/standardsconnection.

www.qualityprogress.com

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WANT THE LATEST QUALITY-RELATED NEWS AND ANALYSIS? The QNT Weekly enewsletter, available exclusively to ASQ members, delivers it every Friday.

Subscribe now at http://email.asq.org/subscribe/qntwk. A hierarchical structure that isn’t

conducive to ideas rising up.

Organizational silos prevent collaboration. Lack of an innovation strategy.

Large team sizes hinder communication.

40.9% 13.6%

36.3%

QP • www.qualityprogress.com 8

Business success with ISO 9001

Q: If an organization wants to implement ISO 9001 for the first time, what is the first step?

A: Use the organization’s purpose as a starting point. Too often, organizations try to appease or conquer requirements as if the end-goal is to satisfy those require-ments.

Not staying true to the organization’s primary purpose (for example, to make money through the product or service offered or to effectively use the available resources to promote educational excel-lence) means the organization may create a competition between the requirements, such as those in ISO 9001, and its organiza-tional purpose.

Using who you are as a business as the reference point for implementing require-ments will help the organization stay fo-cused on what is important without getting lost in the euphoria of becoming certified to ISO 9001.

Q: How do you determine what is nec-essary for a business to continue to be successful in the future? How can ISO 9001:2015 be helpful in doing this?

A: Start by considering what it takes to function as a business (organization) to make money or receive funding today. After you understand this, you can evaluate the true cost of sustaining this.

While some costs are obvious, such as facilities, materials and labor to produce your product or service, don’t forget about less-frequent expenses, such as main-tenance costs, licenses or certifications required to do business, and any other costs related to sustaining the

organiza-tion. Often, organizations don’t account for these costs because they are less likely to get caught by a regulatory body. This isn’t a sustainable business practice, however, because when it comes time to pay for one of these expenses, the money needed hasn’t been accounted for in the budget or pricing structure.

After you have accounted for everything to run your business, think in terms of planning to succeed. Risk-based thinking, management review and data analysis are great for this because they are intended to help you assess actions already taken to determine whether further action is needed. In essence, the organization is either already suitably established, ad-equately addresses all requirements, and is effectively driving behavior, or it has the information and action plan to get there.

Q: How should an organization approach ISO 9001:2015 to make it work for its business?

A: Look at the standard through the eyes of the business instead of trying to make the business fit the standard. In other words, many organizations usually take the stan-dard and go through it clause by clause. To see the standard from a business perspec-tive, lay out the organization as it functions, and plug in the standard’s clauses where they apply to the organization.

This may mean a clause is accounted for in more than one place in the docu-mented system. That is actually a good thing because you are dealing with the organization’s reality instead of simply ap-peasing the standard.

Robert Freeman President, Practical Perspectives McKinney, TX

Selecting consultants, registrars

Q: What are the qualities to look for when selecting an ISO 9001 consultant and registrar?

A: This question is timely because the ISO 9001 and ISO 14001 revisions are scheduled to be released in September 2015. Many organizations planning to use external-expert help in implementing their management systems and that are planning to find a registrar to register their management systems will find this answer useful. This is an important question because choosing the right consultant is critical to accomplishing organizational ob-jectives on time and on budget. Choosing the right registrar is even more important because you likely will stay with the same registrar for several years to come.

Choosing a consultant

ISO 10019:2005 defines a quality manage-ment system (QMS) consultant as a “per-son who assists the organization on QMS realization, giving advice or information.”1

This standard further recommends the following attributes be considered when selecting QMS consultants:

Ethics. Among the many personal at-tributes recommended by the standard, being ethical is a key attribute. An unethi-cal consultant can cause more damage to the organization than an incompetent consultant. Organizations should check the consultant’s past projects with clients to ensure there isn’t any unfavorable feedback. Other personal attributes to look for include: observant, perceptive, versatile, tenacious, decisive, self-reliant, communicative, practi-cal, accountable and facilitative.

Experience. The consultant should be

September 2015 • QP 9 able to understand the organization’s

context and situation and provide creative solutions. This comes from experience in working with different-sized organiza-tions, in various industry segments and geographic locations, and on projects with varying complexity such as providing low- cost, high-value solutions for resource- constrained small business clients.

Education and knowledge. The consultant should not only have the right level of education, he or she also should have the necessary skills to understand products and services. They should have knowledge of all the relevant management systems standards and other international standards required to implement the sys-tem well. Examples include sector-specific, accreditation and product standards, as well as safety-related standards.

The consultant should have expertise or working-level experience in project management and quality management principles, methods and techniques. Implementing the project may require the use of quality engineering tools, statistical techniques, problem solving, risk manage-ment and change managemanage-ment.

Other aspects to consider are industry

knowledge and overall work experience, including previous roles in quality and operations management.

Choosing a registrar

Organizations do not frequently change registrars, so selecting one requires a care-ful review. Knowledgeable customers care about who issued your QMS certification, so it is important to consider the registrar’s reputation. Reputation of an organization is often an indirect measure of the quality of its products and services over time.

If your organization has several locations in a country or around the world, ensure that the registrar has branches and a global presence to support your needs. If your organization plans to become certified to additional management systems stan-dards, such as ISO 14001, OHSAS 18001 or industry standards, ensure that the registrar carries these certifications and that the auditors are qualified to audit to multiple standards. This will allow you to conduct an integrated management systems audit with the help of a single registrar.

The registrar’s accreditation body also matters. Find out if the accreditation body is recognized in the regions where your

organization operates and your customer prefers. Most importantly, your registrar should have local auditors who have solid industry knowledge and experience in addition to proven audit experience. If they must send auditors to you from other regions and geographies to meet auditor skill requirements, it will cost the organization hefty travel and administra-tive expenses year after year.

Ask customer references about the quality of the registrar’s audit and the value added to the organization.

Finally, consider overall audit cost. Ask for the cost breakdown to understand the typical estimated cost for an audit cycle (typically three years). This should include details such as the audit fee, annual file maintenance, audit cancellation fee, annual escalation fee and auditor travel expenses.

The registrar should be responsive to the client’s needs and provide flexibility with scheduling audits. It may be a good idea to ask the shortlisted registrar to conduct a pre-assessment to verify its capability be-fore committing to a long-term relationship.

Govind Ramu Director, quality assurance SunPower Corp. San Jose, CA

REFERENCE

1. International Organization for Standardization, ISO

10019:2005—Guidelines for the selection of quality man-agement system consultants and use of their services.

EXPERT

ANSWE RS

Look at the standard through the eyes of the

business instead of trying to make the

business

fit the standard.

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TECHNOLOGY

Drone Dilemma?

Opportunities abound, but safety concerns have some looking for more regulations

KEEPING

CURRE NT

Since Amazon made a splash a few years ago with plans to incorporate unmanned aircraft systems (UAS) into its package delivery service, all sorts of industries have been abuzz about drones and brainstorm-ing innovative ways to use this burgeonbrainstorm-ing technology.

But is interest and usage in drones mov-ing too fast for the U.S. Federal Aviation Ad-ministration (FAA) to keep up with concerns over safety?

“The FAA has to act and toughen up the rules before a tragedy occurs,

be-cause if a drone were sucked into a jet engine of a plane filled with passengers, untold tragedy could result, and we do not, do not, do not want that to happen,” said Sen. Charles Schumer, D-N.Y., a law-maker who wants the FAA to speed efforts to update regulations and close loopholes covering the use of drones.1

High commercial interest

Already, the FAA has granted special permits while it develops comprehensive rules to govern how commercial drones should share the sky with passenger planes. Proposed rules for commercial drones were released in February, and officials are now reviewing thousands of public comments that were submitted. The FAA has granted 944 com-mercial drone permits as of July 28—with thousands more applications pending.2

For instance, real estate businesses want to use commercial drones to showcase properties with videos taken from the air.

Farmers want to operate them to moni-tor crops and tailor their use of pesticides, herbicides, fertilizers and other applications. Utilities are considering them to inspect electric and gas lines in remote areas.

“To me, the diversity of industries that are coming forward in this initial phase [of applying for FAA special permits] and saying we’d like to fly using [drones] is the most sig-nificant element,” said Brian Wynne, CEO of the Association for Unmanned Vehicle Sys-tems International, a trade group. “We think

there’s a ready-made market out there.”3

After the FAA establishes the guidelines for commercial use, the drone industry said it expects more than 100,000 jobs to be created and nearly half a billion dollars in tax revenue to be generated collectively by 2025.4

It’s also predicted that drone activity could be worth tens of billions of dollars to U.S. companies over the next decade as demand for this technology rises. Organi-zations are expected to spend money on drones to use for surveillance activities, agriculture, weather and environmental monitoring, oil and gas exploration, and aerial imaging and mapping. Government

authorities, such as police, firefighters and other first responders, also are expected to invest in the technology.5

Addressing safety concerns

Along with the excitement and enthusiasm over drones, concerns about aviation safety surrounding this advancing technology persist.

Consider just a couple of recent ex-amples of disruptive drone activity: • Pilots at New York’s John F. Kennedy

In-ternational Airport reported four drone sightings within a three-day stretch in late July and early August. Other reports of near collisions between drones and airplanes have been reported in Austin, TX, and Minneapolis in recent months. FAA rules pro-hibit drones from flying within five miles of an airport and no higher than 400 feet.6

• Unmanned devices were spotted flying above flames and smoke from the for-est fires in July in California, forcing fire crews to ground water-dropping aircraft. The delays allowed the fires to spread, resulting in devastating property losses.7

FAA spokeswoman Elizabeth Isham Cory said the agency receives about 60 reports from pilots each month alerting the agency of drones flying too close to airports, air-planes or helicopters.8

_{Some state and federal-level}

lawmak-ers, as well as private companies, are looking to take action to protect the skies

September 2015 • QP 13

KEEPING

CURRE NT

NAME: Himanshu Trivedi. RESIDENCE: Ahmedabad, India.

EDUCATION: Doctorate from the Birla Institute of Technology and Science in Pilani,

India.

INTRODUCTION TO QUALITY: Trivedi learned from his parents

and teachers at CN Vidyalaya school in Gujarat, India, that quality is to achieve perfection. He was formally introduced to quality by professors at Shantilal Shah Engineering College in Gujarat, India, and the Birla Institute of Technology and Science in Pilani, as well as his doctoral guide. While working at Cromp-ton Greaves and Bosch Rexroth, his mentors also guided him to explore different aspects of quality management.

CURRENT JOB: Vice president and technical plant manager at Bosch Rexroth India. PREVIOUS JOBS: Responsible for quality management and methods at Bosch

Rexroth in India and South East Asia Pacific. He was also responsible for Bosch Production Systems (lean), and health safety and environment at Bosch Rexroth India. When he worked at Crompton Greaves, he learned about the planning and operational aspects of quality management. Also, working in an international envi-ronment at Bosch Rexroth further enhanced his understanding of quality not only as operational, but also as strategic and cultural.

ASQ ACTIVITIES: Trivedi has been an ASQ member since 2001 and helped establish

ASQ’s Ahmedabad local member community in 2010 when ASQ India started its operation. Since then, he has served as chair of the ASQ Ahmedabad chapter and has been actively involved in spreading quality knowledge.

OTHER ACTIVITIES/ACHIEVEMENTS: Nominated as member of the board of

studies for a few institutes in Ahmedabad. Awarded Fellow of the National Center of Quality Management, India. Senior member of the Indian Institute of Industrial Engineers, India.

PUBLICATIONS: Co-editor of Quality Management for Zero Defect and Zero Effect

(ASQ India, 2014). Authored, co-authored and presented several papers at referred journals, and national and international conferences.

RECENT HONORS: Elected to ASQ’s 2014 class of Fellows. Named one of “40 New

Voices of Quality” by QP in 2011. ASQ-certified manager of quality/organizational excellence.

PERSONAL: Wife, Dhara; daughter, Isha; and son, Jignasu.

FAVORITE WAYS TO RELAX: Reading and spending time with family.

QUALITY QUOTE: Quality is creating the right mindset and passionately working

toward excellence through a proactive approach and effective systems.

Q

Who’s Who in

(continues on p. 14)

and further regulate drones:

State: Proposed state legislation in California would allow firefighters and law enforcement personnel to take down drones hindering emer-gency operations. The proposed law would give firefighters and other first responders immunity if they damage drones that are interfering dur-ing a fire or other emergency. Another piece of legislation would make it a misdemeanor to fly a drone over a forest fire. Drone operators could face up to $2,000 in fines.9

Federal: In addition to the FAA finalizing guidelines around commercial drones, a big piece of legislation in Washington, D.C., the Consumer Drone Safety Act, would address concerns around consumer, or recreational, drones. The act would create federal regulations regarding when, where and how consumer drones can be operated, while requiring new safety technologies be built into all new drones.

This includes collision-avoidance technol-ogy, transponders that signal a drone’s location to air traffic controllers and other aircraft, and geo-fencing—technology that creates a virtual global-positioning system fence around no-fly zones that would prevent drones from entering areas near airports or other restricted airspace. The bill also calls for anti-tampering safeguards that would prevent users from modifying con-sumer drones after they are purchased.10

Private companies: Amazon, too, has pro-posed a blueprint for a low-altitude air-traffic sys-tem, said Gur Kimchi, a vice president who heads the company’s drone-delivery division. Trafficking the skies is essential before the world’s largest online retailer can revolutionize how packages are delivered using drones, he said.11

The only way drones can dart across the skies without hitting each other or threatening tradi-tional aircraft is by requiring the equivalence of flight plans to be filed and ensuring that drones

QP • www.qualityprogress.com 14

KEEPING

CURRENT

Mr. Pareto Head

Dealing with drones

communicate their positions to a centralized computer system available to all operators, ac-cording to Kimchi.12

“It’s completely doable,” Kimchi said. “We can only be safe and efficient if everybody else is safe and efficient.”13

Privacy and quality of life

Aside from the concerns about collisions, some drone doubters bring up privacy and quality of life issues, envisioning swarms of drones interrupting sunsets while delivering packages or swooping across backyards to snap photos of unsuspecting sunbathers.

Those concerns have the U.S. National Telecommunication and Information Administra-tion hosting discussions on developing voluntary privacy standards for drones.

“From enhancing news gathering, improv-ing agribusiness and equippimprov-ing new delivery models, to providing internet in remote areas, the possibilities for UAS are staggering,” said Angela Simpson, the agency’s deputy assistant secretary for communications and information. “Consumer trust and responsible operation are keys to fully tapping the transformative potential of unmanned aircraft.”14

—compiled by Mark Edmund, associate editor

REFERENCES

1. “Sullenberger: Drone Aircraft a Grave Threat to Aviation Safety,” Aug. 3, 2015, CBS-DC, http:// tinyurl.com/drone-safety-threat.

2. Bart Jansen, “Study Finds Showcasing Real Estate Most Popular Business Use for Drones,” USA

Today, July 31, 2015,

http://tinyurl.com/more-drone-uses. 3. Ibid.

4. Christopher Doering, “Growing Use of Drones Poised to Transform Agriculture,” USA Today, March 23, 2014, http://tinyurl.com/agricultural-drones.

5. Clay Dillow, “What is the Drone Industry Really Worth?” Fortune, March 12, 2013, http://fortune. com/2013/03/12/what-is-the-drone-industry-really-worth.

6. “Sullenberger: Drone Aircraft a Grave Threat to Aviation Safety,” see reference 1.

7. Matt Hamilton and Veronica Rocha, “$75,000 in Rewards Offered to Catch Operators Who Flew Drones Above Fires,” Los Angeles Times, July 28, 2015, http://tinyurl.com/drones-over-fires. 8. Nick Ferraro, “Drone, Airliner in Close Encounter

Near Twin Cities Airport,” St. Paul Pioneer Press, Aug. 5, 2015, http://tinyurl.com/twin-cities-drones.

9. Matt O’Brien, “Drone Traffic Control? NASA, Ama-zon and Google Partner to Manage Self-Driving Swarms,” San Jose Mercury News, July 28, 2015, http://tinyurl.com/amazon-google-drones. 10. Clay Dillow, “Is Congress’ New Drone Safety

Act an Innovation Killer?” Fortune, June 23, 2015, http://fortune.com/2015/06/23/congress-drone-safety.

11. Alan Levin, “Amazon Envisions Distinct Drone Zones for Future Delivery Fleet,” Bloomberg

Business News,

http://tinyurl.com/amazon-fleet-plans. 12. Ibid. 13. Ibid.

14. Grant Gross, “U.S. to Begin Talks on Drone Pri-vacy Standards,” PC World, July 13, 2015, http:// tinyurl.com/drone-privacy-standards.

ASQ

NEWS

UPCOMING DIVISION EVENTS Three

September and October conferences are being organized by ASQ divisions. ASQ’s Inspection Division will host its annual conference Sept. 10-11 in Dayton, OH. Visit http://asq.org/inspect for more details ASQ’s Biomedical Division is plan-ning its “Design DoJo: Keeping Design Controls Practical and Compliant” con-ference Sept. 29-30 in Boulder, CO. Go to http://asq.org/biomed for information on the event. Finally, the second annual Joint Technical Communities Confer-ence—which involves 10 ASQ divisions— will be held Oct. 22-23 in Orlando, FL. Visit http://asqtcconference.com.

NEW CASE STUDY ASQ’s Knowledge

Center has released a new case study about a team at a medical facility in Dubai that uses the find-organize-clarify-understand-select (FOCUS)/plan-do-check-act (PDCA) model to determine root causes of unreported medication errors and identify potential improve-ments. Read the case study at http://tiny. cc/dubai-asq-case-study.

September 2015 • QP 15

KEEPING

CURRENT

HEALTHCARE

BALDRIGE RECIPIENTS

SCORE HIGH QUALITY

MEASUREMENTS

Healthcare organizations that received the Baldrige National Quality Award matched or ex-ceeded the measurements of healthcare quality and patient experience of their nearby competi-tors, according to a recent study.

Thirty-four organizations that received the award were compared with 153 of their competi-tors located within a 25 to 50-mile radius. Re-searchers examined data for 39 measurements that U.S. hospitals publicly report to the Centers for Medicare and Medicaid Services (CMS).

The patient-experience results data come from Hospital Consumer Assess-ment of Healthcare Provid-ers and Services (HCAHPS) surveys of patients.

“The HCAHPS patient survey results were the most significant findings in this study,” wrote Ron Schulingkamp and John R. Latham, the research authors.

“Hospitals that used the (Baldrige Healthcare Criteria

for Performance Excellence, [abbreviated by the

authors as HCPE]) had higher means and lower standard deviations (indicating a measurable positive patient experience) than the non-HCPE hospitals in all 10 measures,” the researchers wrote.

The differences were statistically significant for nine of those 10 measurements, the authors wrote, showing there is a definite positive ef-fect on patient experience with the use of the criteria.

For more on the study, which was featured in the recent Quality Management Journal article “Healthcare Performance Excellence: A Comparison of Baldrige Award Recipients and Competitors,” visit http://tinyurl.com/baldrige-healthcare.

ASQ JOURNAL SPOTLIGHT

QP occasionally highlights an open-access article from one of ASQ’s seven other journals.

This month, read “Finding Threats and Hazards Simultaneously in the Concept Phase of System Development,” which appeared in the June edition of the Software Quality Professional (SQP).

Author Masao Ito focuses on finding hazards and threats to assure system safety and security. He uses the item sketch and goal model and ap-plies guidewords.

Masao also uses standards and the example of the automobile for explanation purposes, but thinks this method applies to various domains. To access the 10-page article in PDF format, click on the “Current Issue” link on SQP’s webpage at http://asq.org/pub/sqp. From there, you also can find a link to information about subscribing to the quarterly publication.

V O L U M E S E V E N T E E N • I S S U E T H R E E • J U N E 2 0 1 5

Implementing Functional Safety Standards

Richard Messnarz, Christian Kreiner, Andreas Riel, Bernhard Sechser, Klaudia Dussa-Ziegert, Risto Nevalainen, and Serge Tichkiewitch

Taking a Fully Integrated Approach to Implementing Functional Safety According to ISO 26262 Successfully

Serge Tichkiewitch, Andreas Riel, Richard Messnarz, and Christian Kreiner

A GSN Approach for Risk Management in Structured Assurance Cases

Xabier Larrucea and Izaskun Santamaria

The AQUA Automotive Sector Skills Alliance: Best Practice in an Integrated Engineering Approach

Christian Kreiner, Richard Messnarz, Andreas Riel, Serge Tichkiewitch, and Dick Theisens

Finding Threats and Hazards Simultaneously in the Concept Phase of System Development

Masao Ito

Software Quality

Professional

www.asq.org

DATE

IN

QUALITY

HISTORY

QP occasionally looks back on an event or person that made a difference in the history of quality.

Sept. 17, 2013

Eiji Toyoda died at the age of 100 on this date. The well-known indus-trialist helped propel his family’s automobile company—Toyota Motor Corp.—into a worldwide force and changed the way automobiles are made.

Eiji’s cousin, Kiichiro Toyoda, created the automaker but resigned in 1948. Eiji Toyada became involved in the company and was sent to the United States in 1950 to study the auto industry and American manufac-turing methods. He returned and redesigned Toyota’s plants with ad-vanced assembly techniques and machinery.

The unique Toyota management approach had three main objec-tives: keeping inventory to a minimum through kanban or a “just in time” system, ensuring each assembly step is performed correctly the first time, and reducing the amount of human labor that went into assembling each vehicle.

In 1967, Toyoda was named president of the automaker. Under his watch, Toyota sold an all-time high 1.7 million vehicles in Japan and 1.7 million vehicles overseas in 1985, and profits peaked at $2.1 billion.

Toyoda stepped down as chairman of Toyota in 1994 at age 81.

QP • www.qualityprogress.com 16

KEEPING

CURRENT

SHORT

RUNS

THE DEADLINE TO submit nominations for next year’s Harry S. Hertz Leadership Award is Sept. 20. The award is named for the long-time leader of the Baldrige Performance Excellence Program. For more details about the award, the nomination process, award criteria and a list of the 11 selection committee members, visit www. baldrigefoundation.org.

THE U.S. CELEBRATION of World Standards Day, an event that recognizes the critical role of various stakeholders across the stan-dards community, including business lead-ers, industry, academia and government,

will be held in Washington, D.C., on Oct. 1. For more information about the celebration, visit http://tinyurl.com/world-standards-day. TO MARK WORLD Statistics Day on Oct. 20, a data visualization competition is be-ing held by StatisticsView.com and John Wi-ley & Sons Ltd. For more information about the competition, visit www.statisticsviews. com/view/WorldStatsDayComp.html (case sensitive).

THE ASSOCIATION FOR Manufacturing Excellence (AME) announced the eight key-note speakers who will be featured at its annual AME Excellence Inside Conference

Oct. 19-23 in Cincinnati. For more informa-tion about the five-day event, visit www. ame.org/cincinnati.

THE ANSI-ASQ National Accreditation Board has become the first accreditation program to offer the new international featured standards (IFS) Food Store third-party retail inspection standard in the Americas. The IFS Food Store standard is the only third-party inspection program based on ISO/IEC 17020, which is currently available from a leading global scheme owner. For more information about the accreditation, visit http://tinyurl.com/food-store-inspection.

2016 Quality Progress Editorial Calendar

January

Back to Basics: “Best Of” Edition

February

Lean and Six Sigma

March

The Multi-Generational Workforce

April

The Cost of Quality

May

Risk

June

Change and Change Management

July

The QP Career Guide

August

Supply Chain and Stakeholders

September Benchmarking

October

Standards and Auditing

November 40 Under 40

December

Salary Survey

If you want to write for a specific issue,

make sure to submit your article three to

six months before the issue date. That

allows time for the article to be reviewed,

revised and prepped for publication.

Don’t worry if you miss that deadline. Send

the article anyway. All accepted articles

will be published.

Be sure to visit www.qualityprogress.com

and click on “Author

Guidelines” at the

bottom of the

page for more

details.

QP’s 2016 editorial calendar has been released. Now,

we’re looking for authors to write on these topics:

Look

ing for Yo

u

_{r Typ}

e

ASQ certification is a cornerstone of your career growth. You immediately establish yourself as a recognized expert in your field, resulting in promotions, higher salaries, greater demand for your services, and an advantage over your competition. Invest in your career and your future with an ASQ certification. Apply for the upcoming December 2015 exam!

Upcoming Application Deadline: October 16, 2015

Exam Date: December 5, 2015

Get Your ASQ Certification

For more information or to apply for an exam, visit asq.org/cert.

The Global Voice of QualityTM

CERTIFICATION MEMBERSHIP PUBLICATIONS

KEEP

CALM

AND

PREPARE FOR

ISO 9001:2015

Eight experts outline key changes

September 2015 • QP 19

ISO 9001:2015

REVISIONS OF ISO

management systems are often accompanied by

a bit of anxiety. More than 1 million organizations have been certified to ISO

9001:2008, the international quality management system (QMS) standard, and

they now must embark on implementing a revised version to be published later

this month.

Most organizations are on pins and needles: What are the key changes we

must be aware of? When and how should we introduce the required changes?

What resources will we need?

The international technical advisory groups (TAG) to ISO Technical

Com-mittee 176, the group responsible for writing ISO 9001, have toiled to achieve

the highest caliber revision. You can imagine how challenging it is to achieve

a consensus among hundreds of individuals in dozens of countries, with

mul-tiple languages and cultures. This is why a better—although not perfect—ISO

9001:2015 is on track for finalization.

The following pages are meant to calm your anxieties by helping you to

understand five of the key changes in ISO 9001:2015, what they mean, what you

must do to meet the new requirements and the resources available to you

dur-ing the transition process.

Certainly, not every change can be fully detailed in this article, and you’ll

find most of the changes relate to one another. Risk-based thinking, for

ex-ample, which arguably may be the most impactful change in ISO 9001:2015, is

engrained in several aspects of the standard.

In a perfect world, a revision for an established, internationally accepted

standard such as ISO 9001 should be easier to read, learn and implement. It

should provide noncontroversial, improved tools for quality management.

Although our world is not yet perfect, ISO 9001:2015’s new features do provide

promise for improved quality.

—Allen Gluck

Editor’s note: This following article was written by several standards experts before the

release of the final version of ISO 9000:2015. Information presented here was based on the

draft international standard (DIS) and final draft international standard (FDIS) versions

of ISO 9001:2015.

QP • www.qualityprogress.com 20

BILL ASTON is managing director of Aston Technical Consulting Services LLC in Kingwood, TX, and worked 40 years in the oil, gas and chemical industries. A senior member of ASQ, Aston is an ASQ-certified quality auditor, an Exemplar Global-certified quality management system (QMS) auditor and a Professional Evaluation and Certi-fication Board-certified trainer and lead auditor. He is also a voting member of the U.S. Technical Advisory Group to ISO Technical Committee 176 (TAG 176) and the American Petroleum Institute Quality subcommittee 18.

SUSAN L.K. BRIGGS is a member of the task force in the Joint Technical Coordination Group that wrote Annex SL and the associated guidance. She is the chair of TAG 207 on environmental management and the convener of the international working group revising ISO 14001:2015. She has a bachelor’s degree in natural science from Harvard University in Cambridge, MA. Briggs is an ASQ-certified quality/organizational excellence man-ager, auditor and engineer.

CHARLES A. CIANFRANI is a principal consultant for Green Lane Quality Management Services in Green Lane, PA. An ASQ fellow, Cianfrani is a U.S. expert representative to ISO Technical Committee 176 (ISO/TC 176). He has an MBA from Drexel University in Philadelphia and a master’s degree in applied statistics from Villanova Univer-sity in Pennsylvania. Cianfrani has implemented ISO 9001-compliant processes on six continents.

DEANN DESAI is a project manager for Georgia Tech’s Enterprise Innovation Institute in Atlanta. She has a master’s degree in statistics and polymers from the Georgia Institute of Technology in Atlanta. An ASQ member, Desai is an Exemplar Global-certified QMS lead auditor, energy management lead auditor and environmental management systems lead auditor. Desai is a member of multiple ISO standards committees, including TAG 176 and the task force in the Joint Technical Coordination Group that wrote Annex SL and the associated guidance.

ALLEN GLUCK is president of ERM31000 Training and Consulting in Spring Valley, NY, and an adjunct professor at Manhattanville School of Business in Purchase, NY. He has a master’s degree in leadership from Bellevue University in Nebraska. Gluck is an ASQ member and a member of TAG 176, which develops ISO 9001, and TAG 262, which develops ISO 31000.

PAUL PALMES is president and principal consultant with Business Systems Architects Inc. in Fargo, ND, and Prescott, WI. He is a member of TAG 176 and chair of international ISO/TC 176, subcommittee 1, responsible for the revision of ISO 9000. He has been international ISO/TC 176 liaison to the International Accreditation Forum (IAF), co-chair of the IAF’s ISO 9000 advisory group, and member of the Auditing Practices Group and the Ac-creditation Council of the ANSI/ASQ National AcAc-creditation Board. Palmes is an ASQ-certified quality manager, British Standards Institution-certified ISO 9001 auditor and has a master’s degree in administration from Gon-zaga University in Spokane, WA.

DENISE ROBITAILLE is the author of 12 books, including ISO 9001:2008 for Small and Medium-Sized

Business-es (ASQ Quality PrBusiness-ess, 2010), and an internationally recognized speaker and trainer. She is an active member

of TAG 176, where she has participated in the revision of multiple standards. Robitaille is an ASQ fellow, an Exemplar Global-certified lead assessor and an ASQ-certified quality auditor.

JOHN E. “JACK” WEST is a member of Silver Fox Advisors in Houston. He is past chair of TAG 176 and lead delegate of the committee responsible for the ISO 9000 family of quality management system standards. He is an ASQ fellow and has co-authored several ASQ Quality Press books.

September 2015 • QP 21

ISO 9001:2015

Prepare for a New Structure

by Deann Desai and Susan L.K. Briggs

What is the change?

The structure of ISO 9001 has been revised. Clauses and subclauses are retitled and reordered according to a high-level structure that allows for all management sys-tem standards (MSS) to be aligned.

To fully understand this change, some background explaining why it was done should be helpful. From the early 1990s, the International Organization for Standard-ization (ISO) technical committee for quality manage-ment (ISO/TC 176) and its technical committee for en-vironmental management (ISO/TC 207) worked together to enhance compatibility and avoid conflicting require-ments between ISO 9001 and ISO 14001, the internation-al environmentinternation-al MSS.

In 2003, the ISO General Assembly received advice from advisory and user groups that greater alignment of the structure—including clause sequence and require-ments in the standards—was desirable and achievable, and that this would benefit organizations implementing more than one MSS.

In 2005, the ISO Technical Management Board estab-lished a technical advisory group to fulfill this task, and a joint vision and high-level structure for all MSSs was de-veloped. Building on this, the group developed the MSS requirements, which were published as Annex SL in the

ISO/IEC Directives1, 2 _{in 2011.}

Annex SL defines the high-level structure including common text, terms and definitions along with guidance on how they should be applied. The impact of Annex SL is that all ISO management system requirements standards will be aligned, and ISO will seek to enhance the compatibility of these standards through the promotion of identical: • Clause titles.

• Sequence of clause titles. • Text.

• Terms and definitions.

These items are permitted to diverge among stan-dards only where necessitated by specific differences in managing the individual fields of application.

What does it mean?

The aim of Annex SL is to enhance the consistency and alignment of existing and future ISO MSSs by providing

a unifying and agreed-on high-level structure, identical core text, and common terms and core definitions.

There are 10 elements in the Annex SL high-level structure:

1. Scope.

2. Normative references. 3. Terms and definitions. 4. Context of the organization. 5. Leadership. 6. Planning. 7. Support. 8. Operation. 9. Performance evaluation. 10. Improvement.

These elements have driven the changes that users will find in ISO 9001, including the restructuring of the standard from eight clauses in the 2008 version to 10 clauses in the 2015 version.3

What do I need to do?

A frequently asked question about this change is: “Must organizations renumber their documents and other rel-evant items based on the new structure of the standard?”

The short answer is: No, you do not need to renumber, but many organizations will choose to do so as a tracking mechanism—a way to keep things straight and ensure they are able to do a full review and cover the require-ments. Keep in mind that there is no guarantee the num-bering will remain the same in future revisions.

Some of the main changes in ISO 9001:2015, includ-ing introduction of context of the organization and risk, came from the use of the high-level structure.

One of the key responses in the user survey conduct-ed prior to writing the revision was that the connection with the larger, strategic view of the organization was missing. The introduction of a clause related to a con-cept called the “context of the organization” addressed this concern.

The intent of this clause is for organizations to have a high-level (strategic) understanding of the important is-sues that can affect a management system—positively or negatively. Part of an organization’s context also includes relevant needs and expectations of interested parties that