Mood Righting
U.S. organizations face monumental challenges as a global economy has emerged. Arguably, the global economy is driving competitive forces to levels unimaginable only a few decades ago....

Balancing Act
With common quality methods and standards in place, manufacturing organizations share a daunting challenge: an increased volume of electronic and paper-based data collected during process development and manufacturing....
Expert Answers: May 2013
Lean case studies from IT organizations...
Innovation Imperative: Risk and Development
In my first Innovation Imperative column, I wrote that, in short, innovation is a risky business. In this month’s column, I am going to move beyond identifying the nature of the risks we must address and look at how we manage those risks....
Standards Outlook: World View
The global economy has provided organizations with many opportunities that didn’t exist even 10 years ago. On the other hand, the internet and extensive outsourcing have “flattened” the Earth, presenting organizations with many new risks....

Paving the Way
Data and information are at the heart of good investigations and decision making, but are all kinds of data the same? What are the major categories and types of questions to ask to collect and analyze data?...
Statistics Roundtable: Getting Graphical
A company has six manufacturing processes critical to its business success. Management recently required each area manager to provide quarterly reports on the performance of their particular process....
Heart of the Matter
The goal of most processes in the manufacturing and service industries is to produce products or services that exhibit little to no variation. Variation is defined as “where no two items or services are exactly the same.”...
Tool Time
“Does everybody know what time it is? It’s ‘Tool Time’!” On “Home Improvement,” one of the most watched TV sitcoms in the U.S. in the 1990s, Tim and his assistant, Al, demonstrated to their television audience what tools they had and how to use them....
Standards Outlook: What’s Cooking?
The U.S. Federal Drug Administration Food Safety Modernization Act is another milestone in food safety—the latest step to supplement hazard analysis and critical control point programs that have been mandated for a variety of commodities....
Expert Answers: April 2013
Root cause analysis tools ... Calibration data for a fee ......
Statistics Roundtable: Let's Be Realistic
Decision making is all about understanding and comparing trade-offs between choices: What benefits are possible, what are the risks and can they be mitigated, and what will each of the alternatives cost?...
Five at the Forefront
ISO 19011:2011 is an international standard that provides guidance on auditing management systems. Using ISO 19011 is not mandatory, and organizations are not required to reference this standard in their auditing procedures....
Measure for Measure: Verifying the Art
Measurement may be considered a science and an art. It is a science in that it is based upon the laws of physics and math. Some consider it an art because elements of human judgment are needed to translate measurement from abstract to real application....

Apples to Oranges?
Consumers around the world demand safe food. Through the years, retailers and food companies have pushed their suppliers to have food safety systems and improve on them. The drive started with suppliers being required to have third-party good GMP audits....
Before the Fact
The FDA has ratcheted up its surveillance and inspection activities on the suppliers of food and dietary supplements. Growing concern over protection of America’s food chain has been voiced by the FDA’s commissioner of food and drugs....

The Right Ingredients
In Out of the Crisis, W. Edwards Deming writes, “Everyone doing his best is not the answer. It is first necessary that people know what to do.” To ensure people know exactly what to do, all activities within the organization should be system oriented....

March 2013 One Good Idea - online figures
CAPA process swim lane diagram / online Figure 1 Phase 1: Initiation Phase 2 and 3: Investigation and Corrective Action Issue CAPA number Enter CAPA info into log Notify quality manager CAT investigation CAT investigation Identify issue Meet with process...
Know the Why
One of the primary reasons improvement projects fail is a lack of alignment with an organization’s vision, mission, goals and objectives. In an attempt to avoid that issue, a government agency in Guyana deployed a multi-tool method for improvement....

The Right Blend
Faced with cost reductions and scheduling changes, a chemotherapy mixing room (CMR) implemented the define, measure, analyze, improve and control method and lean tools to optimize operations....
Lessons in Labeling
What kind of care would you want for a loved one fighting cancer? This is the question the experts at Cancer Treatment Centers of America ask themselves every day and motivates employees to create a culture where continuous improvement becomes a habit....
Statistics Roundtable: Group Effort
Cluster analysis is being widely used in disciplines as diverse as marketing, genomics and climate change. The technique lends itself to large data sets and small, focused data sets....
Expert Answers: February 2013
Root cause analysis...

Online Figures - Vanicek
daily volume Total time ( hours) Drug receiving/ reconciliation 0: 51: 00 0: 51: 00 Injectables ( RT) 0: 01: 09 25 0: 28: 45 Pump receiving 0: 01: 32 9 0: 13: 48 Pump assigning ( existing) 0: 01: 43 7 0: 12: 01 Pump assigning ( NP) 0: 07: 00 1 0: 07: 00 ...
Online Figures - Ramsay
Year Verct( dys) # Rpts FinRpts InvTech #_ Staff 2003 296 31 13 1.00 216 2004 829 24 11 2.24 190 2005 309 22 12 1.65 210 2006 222 22 9 2.35 225 2007 171 17 5 3.58 247 Verct( dys) = verification of claims cycle time # rpts = number of reports for the boar...
Standards Outlook: Corrective Action Challenge
The purpose of corrective action is to prevent the recurrence of the problem. There are usually many actions that can be taken to address the problem, ranging from incremental changes to innovative solutions....
Why Certify?
These stories are told by people at different stages of their careers. One of the things they have in common, however, is they’ve carefully considered the costs and benefits of ASQ certification....

One Good Idea: Ultimate Originality
When developing products for a new market, innovative ideas are essential. A tool that can be used to spark innovative new product ideas is the ideate, define, design and validate (IDDV) method....
In the Crosshairs
In 2005, Fairbanks Morse Engine discovered that work content analysis can help clearly define product families and can align improvement activities in a leveraged execution....
Rain Gauge
The Six Sigma define, measure, analyze, design and verify process is appropriate for exceedingly complex engineering construction problems that require the use of simulation and design of experiments....
Statistics Roundtable: Inquiry on Pedigree
THE MEDIA FREQUENTLY report on examples of situations in which results from statistical studies are not reproducible. A recent article in the New York Times reported how a sophisticated study went wrong because of poor data quality....
Standards Outlook: Get in Front of the Problem
Considering the unfortunate fact that product recalls and their disastrous results seem relatively common, it’s curious why so many organizations resist formal efforts to address preventive action....

Salary Survey 2012: Crunching the Numbers
The 2012 survey was sent to 54,337 members. Of the 6,857 individuals who started the survey, 6,857 completed the questionnaire for a response rate of 11.2%....

Back to Basics: Breaking It Down
A3 thinking is based on the plan-do-check-act cycle. This powerful way of thinking is transcribed on a piece of paper (the A3 report) a team of employees can use to produce a desired outcome for a proposed process....
Salary Survey 2012: Part 1, Section 1: Salary by Job Title
Figure 1 includes results for: x Full- time employees, part- time employees, x U. S. employees, Canadian employees, International employees Salary by job title for U. S. respondents / FIgUre 1 46,884 50,558 53,970 56,246 57,718 69,279 70,094 72,261 74,13...
Salary Survey 2012: Part 1, Section 4: Salary by ASQ and RABQSA International Certification
Percentage of respondents holding aSQ certifications / Table 1 2012 2010 2008 Certified quality auditor 22.9% 24.1% 24.2% Certified quality engineer 20.4 23.7 21.6 Certified manager of quality/ organizational excellence 12.6 13.7 12.6 Certified Six Sigma...
Salary Survey 2012: Part 1, Section 18: Salary by RABQSA International Certification
Part 1. Regular Employee Results Section 18. Salary by RABQSA International Certification Details on RABQSA Certifications Salary by RABQSA certifications for U. S. respondents / Table 1 Aged care professional APIQ auditor AS9100 aerospace experience aud...
Salary Survey 2012: Part 2, Section 23: Base Earnings by Education and Training
1 28,000 28,000 Certified manager of quality/ organizational excellence 20,000 275,000 86,193 9 112,391 100,000 Certified quality auditor 12,000 180,000 56,553 17 87,066 96,521 Certified quality engineer 12,000 214,245 71,048 10 96,625 82,500 Certified q...
Expert Answers: December 2012
A better supplier scorecard ... Inspecting your suppliers ......

Online Figures - December Back to Basics
alt section Remove engine Critical inspections Hydro cks Adjust 2410 Adjust 2410 TCI/ TCTO Supply Get topics E/ E AFG Fuels A/ V A/ R Egress B/ M NDI Looks Tools Egress Egress flow cks M/ T AFG & lube Remove elevators Weigh elevators AFI Props RFLTS TCR ...

Quality Around the Clock
It’s in your DNA. It’s how your mind works. It’s what you do. It’s who you are. When you work in quality, you see things differently. You approach problems and scenarios in certain ways. It happens after you’ve signed off....
Statistics Roundtable: Improve Your Evaluations
In an earlier Statistics Roundtable column, we described how the conclusions you can draw from statistical analysis of limited life data can be bolstered by appropriately incorporating engineering knowledge and experience into the analysis....

Back to Basics: To DMAIC or Not to DMAIC?
Define, measure, analyze, improve and control is a structured problem-solving method. Each phase builds on the previous one, with the goal of implementing long-term solutions to problems. Most problem-solving efforts benefit from a disciplined method....
Volviendo a los Fundamentos: ¿DMAMC o no DMAMC?
Definir, medir, analizar, mejorar y controlar (DMAMC) es un método estructurado de resolución de problemas. Cada fase de DMAMC se basa en la fase anterior, y el objetivo es implementar soluciones a largo plazo a los problemas....
Standards Outlook: From the Trenches
ISO 9001 and the COSO internal control guidance document used by financial organizations that must comply with the requirements of the Sarbanes-Oxley Act don’t have a lot in common, but one thing they share is the need to update the current version....

Quality in the First Person: Pursuing Excellence
This is the story of my journey from lackadaisical and passive performance to data-driven dominance during my collegiate football career as a punter....

One Good Idea: Keep Moving
Many decision makers do not properly distinguish uncertainty from risk. When this occurs, there’s a tendency to spend too much time studying the problem, leading to a phenomenon often called “analysis paralysis.”...
Expert Answers: November 2012
Surveys in the toolbox ... Auditing it all ... Reference materials in ISO 17025 ......
Law and Order
The laws created and enforced by government are among the most important works of humankind. They address the most significant societal problems and have a direct impact on human rights, living standards and the quality of life of every person....
Shift Into High Gear
When customers of tgestiona began expressing dissatisfaction about the its inefficient service and delivery processes, it began a transport optimization project that earned gold-level status in the 2012 ASQ International Team Excellence Award process....
Lasting Impression
A recent paper found that quality initiatives have made significant contributions to three primary indicators of economic well-being: gross domestic product, corporate tax revenues and employment....
Healthy Returns
The future of any enterprise depends on the quality of its customer service. All organizations—even those manufacturing products—are service organizations because all create value for customers by performing services....

Perspectives: Added Structure
Global good manufacturing practices (GMP) and regulatory guidelines ensure the “safety, identity, strength, quality (and) purity of drug(s).” Manufacturing and quality control testing of approved drugs fall under these GMP regulations....
A Service Framework
To help service quality professionals negotiate the unique challenges they encounter, the ASQ Service Quality Division envisaged the Service Quality Body of Knowledge as an umbrella framework....
Making Contact
For an organization to be able to truly understand how well it’s meeting customer expectations, more concrete, measureable metrics must be used....

Hearing Aids
Today, hundreds of organizations regularly conduct surveys and focus groups, solicit comments and complaints, scour social media and gather data from other sources....
Statistics Roundtable: Weighing Your Options
When we are faced with choosing the best solution for a problem, most of us are very good at picking the right solution if there’s only a single quantitative objective over which to optimize....
Expert Answers: October 2012
Finding the right role ... Audit mismatches ... Accuracy in calibration...

One Good Idea: Survey Fatigue
Who among us has not suffered the endless assault of satisfaction surveys? Society is surveyed out, but that doesn't mean the pursuit of meaningful customer feedback is a waste of time. It's just that the challenge is getting more difficult....
Online Figure Kennedy
QP 2 Mayo Clinic Arizona Outpatient Department Prepared 10- 12- 11 Enterprise percentile ranking benchmarks > 90th 75th- 89th < 75th 37 . Response text 2003 2004 2005 2006 2007 2008 2009 2010 2011 Percentage excellent Clinic- Medical specialist percenta...
(Re)visionary Thinking
The preeminent ISO standard on environmental management, ISO 14001, is being revised to incorporate new approaches in the field of environmental management systems and meet stakeholder expectations that have evolved since it was first published in 1996....
Clever Combination
As software use increases in safety-critical applications, we must implement quality improvement tools and techniques to identify software failures before they have a critical effect on the completed system or a fatal effect on the end user....
Pick Your Spots
In the rush to achieve results, lean Six Sigma programs can get derailed because projects are pushed through the organization, leading to the selection of the wrong projects and suboptimizing the entire enterprise’s goals....
Expert Answers: September 2012
Sustaining excellence ... Blood bank error...
Standards Outlook: On the Lookout
Audit program managers have always dealt with risk in some manner. They’ve analyzed and evaluated risk, as well as monitored and reported it. Now, all of those activities are becoming a formal part of an audit program manager’s duties....

Career Corner: Light Your Fire
It takes the right team members to create an enabled, empowered, motivated, cross functional, self-directed team capable of selecting the most important tasks, and then efficiently and effectively solving the most critical problems....
Innovation Imperative: A Question of Balance
Many people say that mentioning standards and innovation in the same breath is a contradiction in terms. Evidence from the real world says otherwise....
Statistics Roundtable: Fleshing Things Out
Recently, a colleague asked me to review some data that a student had gathered on cannibalization in spiders. They had 10 families of spiders, and each family had 14 members. We’ll call the families A, B, C, etc. The families were randomly paired off....
Rethinking Treatment
Changing and improving complex processes in healthcare settings are no easy tasks. They require a systems approach using a variety of quality improvement methods and tools....

Change Ability
Building on the creative spirit of each individual joined with others is at the heart of transforming organizations so they don’t just weather forces of change, but also capitalize on the immense energy inherent in the surge....

One Good Idea: Finding the Gaps
The gaps model of quality can help an organization take a big-picture look at its processes. There are five potential quality gaps, which are be described in this article using examples from a passenger airline service....
Standards Outlook: Game of Chance
Risk is a popular word being added to the standards and procedures lexicon, but it’s a massive topic that can be confusing. It can get even more complicated when you try to put risk in a box....
Expert Answers: August 2012
Innovation issues ... SPC vs. SQC ......
Improving on Excellence
With the changing face of healthcare in the 1990s, the Mayo Clinic started to measure more thoroughly the results of its efforts to track quality. So it enlisted the help of the Juran Institute to begin a full-fledged quality improvement program....
Blaze Your Own Trail
We used to put our careers into the hands of our organizations. If we worked diligently enough, they might reward our efforts with a series of promotions. This template for career advancement was a clean 45-degree line....

Learning to Fish
The career excellence diagram, a modified version of the fishbone diagram, can be used to create desired results in career development by identifying causes that will ultimately lead to success....

Statistics Roundtable: Words of Caution
Suppose you have a study with one identified response. Take QP’s salary survey, for instance, and the many predictors, such as age, sex, education, years of experience, type of employment and number of people supervised....
The Audit Answer
Graduate students at Bowling Green State University studied the Quality Systems Educational Collaboration, a program that addresses workforce and technical assistance needs for organizations, and disclosed areas for improvement using Six Sigma methods....
In the Spotlight
Based on what we know about the skills needed for innovation management, what quality management functions, responsibilities and skills can be applied to manage innovation?...

Up and Away
Do you want to quickly test your creativity? Take a sheet of paper and draw a big circle on it. Draw a dot on the paper. This exercise is part of a test given to children entering kindergarten to find out their baseline levels of creativity....

Perspectives: Relying on the Basics
It’s difficult to improve a process that isn’t running. Equipment reliability from a manufacturing equipment perspective is typically the purview of maintenance teams and may include watch-over by the engineering team....
Standards Outlook: Ingraining Innovation
The concept of innovation has been around for a while, but it has grown and evolved to become an issue of significant, if not critical, importance to organizations....

One Good Idea: Designing for Accuracy
For this column, I used regression analysis and design of experiments (DoE) to create a model for predicting production rates in a paper stock cutting facility....
Valuable Resource
Talent development is addressed in three key components of sustainability management systems: international standards, social responsibility (SR) reporting and performance excellence frameworks....

Back to Basics: Team Advantage
Process management teams provide a framework through which complex, cross-functional processes can be assessed and optimized. By focusing on these seven activities, process management teams can provide the value they are uniquely positioned to deliver....
Statistics Roundtable: Going on Feel
Customers consider consistent quality to be one of the most important product and service attributes. Often, it’s the most important....

Fair or Foul?
After Moneyball was published nine years ago, Oakland A’s GM Billy Beane was hailed as a genius for adopting analytics in baseball. His goal was to create a small-budget MLB team that could compete with big-spending teams in the American League....

Beyond the Basics
A movie sequel often can be as, if not more, captivating than the original. Essentially, a sequel builds on the original, continuing a journey with familiar characters and settings, developing ideas and unveiling more insight....
Statistics Roundtable: On Overlapping
While teaching a workshop for a small manufacturing firm, two of the participants approached me to discuss what seemed to be a simple problem they had encountered at work....
Standards Outlook: Revised Thinking
COSO developed the internal control integrated framework in 1992 in response to the savings and loan scandals of the 1980s. COSO is now 20 years old and is due for an upgrade to incorporate changes in the financial environment....

Back to Basics: Creative Combination
I have been facilitating lean Six Sigma projects and coaching other belts through their projects since 2002. Combining tools is a technique I use with teams when potential root cause analysis through a fishbone diagram does not show any obvious direction....
A Tangled Web
In simple terms, software as a service is on-demand access to software via the internet. It seemingly eliminates the installation and testing of the software by the customer—or does it?...
Standards Outlook: Complex Relationship
In addition to being required to master a multitude of global requirements, regulatory professionals must address other issues that impede their ability to function expeditiously....
Taking the Wheel
Customer experience has become the mantra of senior management looking to enhance revenue and margins. In fact, more companies are trying to differentiate themselves not only on product quality but also on total customer experience....
Quality Curriculum
Does quality exist as an entity independent of business? Are the business of quality and the quality of business simply two sides of the same coin? No matter—the quality discipline has become inextricably woven into business....

The Power of Positive
In his 2006 book, The World is Flat, Thomas Freidman cites the many challenges globalization puts on corporate life: changing political realities, social entrepreneurship and the effects of the internet....
3.4 per Million: Know What You Want
Having learned Six Sigma in the 1980s now creates an interesting box to live in today. Six Sigma was a strategy to achieve the corporate vision of total customer satisfaction....

Perspectives: Taken for Granted
The ISO 9000 series is Quality 101, and as quality practitioners, we should never forget it....

Career Corner: Keep Your Toolbox Full
Be aware of all the tools at your disposal to excel at your job. Your career as a quality professional depends on your ability to recall a specific quality tool and apply it when necessary....
Online Sidebars Goodman
The customer experience framework, shown in Figure 1, allows the VOC and quality improvement activities to be placed in the context of the overall customer experience, which includes the intended basic customer experience plus all service contacts. The be...


