Standards Outlook: Trust, but Verify
Grouping product, service and process audits together is somewhat natural, because a process audit may include a product or service audit. I’ve dubbed the combination a verification audit....
Attitude Shift
In a used-car dealership group based in Richmond, VA, a lean culture change took place that started with a redesign of its process for reconditioning used cars and ended with numerous benefits, some of which it didn't expect....
What's on the Horizon
As an industry evolves, so, too, do the standards and regulations that govern it. The aviation industry has seen several changes made recently, and more are on the way....
Managing Expectations
One condition is vital for initiating, implementing and sustaining a viable quality initiative: management support. Surprisingly, very few articles and books on quality even mention this need, let alone what to do if support isn’t there....

Spring Into Action
Last year, I was presented the National Medal of Technology and Innovation. It was a great honor for all of us at General Systems Co.—and for all of us in the quality profession—to be recognized for our efforts related to total quality and innovation....
Expert Answers: November 2009
The TOPS way of getting to the root cause ... Repair vs. rework...
Starting Line
So, you’ve volunteered (or, as one of my coworkers says, you’ve been “volun-told”) to lead your company through the implementation of ISO 9001. Now what do you do?...
Think Again
If we stop and contemplate why we think of audit results as pass or fail, we may become more aware of how our mentality affects the way we behave during an audit and how that mind-set influences others....
Critical Stage
Has Six Sigma been a good thing? While this is a straightforward question, there isn’t a simple answer....
Standards Outlook: The Right Approach
The process approach is at the heart of a quality management system (QMS) defined by ISO 9001. And, as everyone knows, it’s necessary to have the old ticker checked out from time to time....
PDSA Leads to Top Accolades
Force field analysis. Two-way communication. SWOT analysis. These terms are likely familiar to quality professionals in the manufacturing, service and possibly even healthcare fields. But to those in education? It’s unlikely....

Tune Up
Six Sigma has many meanings. In its simplest context, Six Sigma can be defined statistically as the attempt to achieve near-perfection by having no more than 3.4 errors per million opportunities, or being 99.997% correct (or defect-free)....
World of Confusion
U.S. manufacturers of medical devices must comply with U.S. Food and Drug Administration (FDA) labeling requirements and also face the challenge of labeling in multiple languages if they want to sell their products in the global marketplace....
Get Your Checkup
For nearly 20 years, lean and Six Sigma improvement initiatives have been in the quality spotlight, helping thousands of organizations in the United States and elsewhere. But, are hospitals truly embracing the lean and Six Sigma movement?...
Watershed Moment
Cargill Corn Milling North America approached its Baldrige site visit in 2008 with the same level of preparation any organization would, but with the unique perspective that comes with rebuilding your operation after surviving a natural disaster....
Progress Report
Six Sigma has been a hot topic discussed and implemented globally in the business world, nonprofit organizations and even governments. There is comparatively less research, however, into how to assess the maturity of Six Sigma implementation....

The Right Move
Shortcomings in both measurement systems and traditional methods for assessing customer satisfaction affect the ability of most firms to directly link quality improvements to changes in financial performance....
Don't Just Talk the Talk
Many companies and organizations talk big about knowing the best way other businesses and groups can work to drive continuous and process improvement. Often, these businesses don’t take their own advice. Once in a while, however, a group comes along...

All Ears
Imagine you are presenting the analysis and findings of a critical operational issue or proposed improvement project to senior management. You feel confident because you’ve thoroughly measured and analyzed the data....
Standards Outlook: Revised AS&D Standards Take Flight
The International Aerospace Quality Group has released the IAQG 9100:2009 aviation, space and defense standards in all three of its sectors....
Pyramid Power
The next evolutionary step for Six Sigma could be a method called 6TOC (pronounced “six-tock”) that combines principles of lean Six Sigma with the theory of constraints....
Standards Outlook: Effective Audit Programs
Today's organizations need to be agile and responsive to the changing requirements in private and public business sectors. Properly directed, internal audit program resources can help an organization stay focused and uncover improvement opportunities....
Narrow Healthcare's Quality Chasm
Today's healthcare leaders face the need to effectively manage not only the clinical but also the business side of their operations. This includes demonstrating cost reductions, overall organizational improvement and long-term sustainability....
Take a Bite Out of Inefficiency
Providing consistent and effective service or product requires a consistent and effective framework for implementing, maintaining and improving tactical and strategic operations. Dentistry is no different....
The Right Mix
Six Sigma offers a framework for process improvement based on objective data. W. Edwards Deming once said, “In God we trust: All others bring data.” For many Six Sigma practitioners, that’s become their undying motto....

Can Do
Executing a food-systems audit brings with it a series of specific issues to consider. When performing an audit in a country that is not their own, however, auditors face additional challenges. With proper planning, those challenges can be overcome....
Statistics Roundtable: Grab the Brass Ring
Remember going to the amusement park and riding the carousel or merry-go-round? During the ride, there was sometimes a brass ring you could grab from a dispenser.It took some dexterity to snatch the ring from the dispenser as the carousel rotated....

Perspectives: First, Do No Harm
Healthcare costs in the United States are increasing at staggering rates. In fact, last year’s employer health insurance premiums increased by 5%, which is two times the rate of inflation....
Small Change, Big Impact
Little has changed in the fourth edition of ISO 9001, which was issued late last year by the International Organization for Standardization. ISO 9001:2008 contains no new requirements, so the transition should be painless for most organizations....
3.4 per Million: Smart Talk
When you examine the success of Six Sigma at Motorola, one characteristic that is frequently listed as a critical success factor is the common language it created. That attribute meanders its way into all types of Six Sigma conversations....
Keep on Truckin’
In July 2005, a transportation representative at Bayer MaterialScience identified a potential problem with the way the company chose its shipping carriers. Bayer, a global manufacturer of polymers used as raw materials for products such as compact...

Change That Sticks
Process improvement is gaining more attention as organizations face budget cuts, competition from developing markets overseas and a challenging economy....
Keeping Score
Like most of you, I’ve seen the “latest, greatest thing” introduced in organizations — repeatedly. We observe initial excitement for the new strategy, bursts of employee training, spotty implementation and eventual abandonment of the new approach....
Online Figures Perspectives
Adapted from Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings, U. S. Department of Health and Human Services, Centers for Disease Control, 2007. Jan. 9, 2008 CDC staff arrive in las Vegas to provid...
FMEA Minus the Pain
Failure mode effects analysis has stood the test of time as a powerful risk assessment tool for products, processes and systems....
Standards Outlook: Dynamic Duo
Lean and Six Sigma are two methods aimed at improving the quality of an organization’s operations and its financial results. Both concentrate on customer satisfaction and improved business performance....
Off the Ground
None of the 4,000 fasteners that were hand drilled into the fuselage of any C-17 cargo plane was misaligned or had gone missing. For years, Boeing has been building these top-notch planes. It just wanted to build them better....
Expert Answers: March 2009
Return policy ... restructuring activities ... sample size....
Quality in the First Person: Be All that You Can Be
At first glance, my journey into the quality world may seem unusual. But when I look back, I see that it wasn’t about where I worked or what type of job I had, it was more about how I did those jobs and what they did for me....
Standards Outlook: Risk and Quality Management
The media has made all of us aware of the global financial crisis caused by the assumption of risk by banks and speculators in stocks and commodities....
ISO-lating the Problem
When two healthcare organizations were searching for a way to better manage their activities, both turned to ISO 9001:2000 in the hope that the standard could organize their practices and help them improve service to patients....

Perspectives: In Crisis, Give Credit to Quality
The financial industry needs a quality framework for manufacturing and controlling complex mathematical models, technological systems and financial data. Therefore, if Congress enacted strict quality standards for financial data and its distribution, the ...

Back to Basics: Clearing SPC Hurdles
Statistical process control (SPC) has provided significant cost savings for companies that are fortunate enough to implement it fully. However, implementation challenges can overcome the best of intentions....
The Quality Professional as Organizational Gardener
Many quality professionals understand that the answers to these questions require the ability to envision their organizations as living entities, existing within their understanding of systems theory. We work with organizations and people, not on organiza...

Energize Your QMS
Changes to the ISO 9001:2008 amendment are high benefit and low impact. This position stated the following: "ISO 9001:2008 has been developed to introduce clarifications to the existing requirements of ISO 9001:2000 and changes that are intended to improv...
3.4 per Million: Putting It All Together
For companies that have been asking themselves how to achieve even more improvement, the answer lies in developing a comprehensive process management system that integrates three critical components....
Drill Deep for Strategic Alignment
Internal auditors must understand an organization’s strategy and how each process fits into that strategy. Internal auditing for strategic alignment and execution requires that the auditor understand the organization’s desired strategy and how each proces...

Futures Study
Forces of Change From All ASQ Futures Studies Table 1 1996 1999 2002 2005 2008 Changing values Partnering Quality must deliver bottom- line results Globalization Globalization Globalization Learning systems Management systems will increasingly absorb the...
Newer Better Faster
The Small Business Administration has indicated that the majority of innovations are consistent with the continuous improvement commonly used in the define, measure, analyze, improve and control (DMAIC) Six Sigma method....
Standards Outlook: Down With Silos
Businesses today have multiple management systems, including financial, quality and environmental. Unfortunately, these management systems usually do not talk to one another....
Online Radziwill
The QMS has four components, starting with an organizational assessment to the QMS framework, and covering methodologies and tools that can be applied to problem solving for specific processes. This chart outlines five steps that can be taken to logically...
Starting From Scratch
Graduate students studying quality developed the Quality Systems Development Roadmap to help organizations do this, using application templates from the Lean Six Sigma Quality Transformation Toolkit. However, new companies, organizations without an enterp...
Driven by Metrics
Performance metrics are a necessary part of managing an organization. However, they have good and bad impacts on individual behavior, so organizations need to find ways to maximize the good while minimizing the potential damage....

Keeping Current Online Table
Malcolm Baldrige National Quality Award: National Institute of Standards and Technology ( NIST) in partnership with ASQ Award criteria are built on seven core values: leadership, strategic planning, customer and market focus, information analysis, human ...
A Dose of DMAIC
Ruby hospital, a multispecialty for-profit facility in Calcutta, India, was the first in Eastern India to embrace ISO 9001 and is the only one in the country to have successfully deployed a Six Sigma improvement program....
Building Blocks
Like many other countries around the world, Canada offers a national quality award to recognize and encourage organizations to attain outstanding levels of quality performance....
The Road to Improvement
Registration of public organizations to the ISO 9001 quality management standard can be difficult because of their complex operations and extensive documentation....
Standards Outlook: Ready for Takeoff
The International Aerospace Quality Group (IAQG) is putting finishing touches on the next revision of AS9100, the quality management system (QMS) standard for the aviation, space and defense (AS&D) industries....
Online ARDEC
Pilot/ execute, initial evaluation, improve, further implementation Enterprise excellence Invent & innovate, design, optimize, verify Define, measure, analyze, improve, control Define, measure, analyze, lean, control Concept, design, optimize, verify Pla...
Far-Sighted
In the first year nonprofit organizations could apply for the honor, Coral Springs became the first local government to take home a Baldrige award by proving it didn't emphasize the present at the expense of the future....
Customer Servicemen
Customer Feedback is a key component of improvement. The challenge has always been finding the most effective way of procuring it....
Expert Answers: June 2008
Calculating DPMO ... Origins of sampling plan....
Incredible Journey
In response to personnel’s safety concerns and rising workers’ compensation costs, a team at Boeing’s C-17 site developed a solution to thwart injury and save money....
Two Are Better Than One
Management need and my personal curiosity recently led me to take a closer look at the Sarbanes-Oxley Act (SOX). My work pointed out similarities and differences between SOX and ISO 9001....
Measure for Measure: A Clearer Picture With RCA
The next step to crafting a successful quality assurance program is conducting root cause analysis (RCA) to examine the individual nonconformities, and then performing trend analysis to determine the most significant nonconformities and the root cause....
Expert Answers: May 2008
Government and cost of quality ... Understanding the slack factor....
Helping Ease the Transition
Six Sigma and process improvement projects include implementation steps that typically alter workflow and deployment of labor to create a more effective and efficient process. New connections and relationships are established that reinforce new methods....
Statistics Roundtable: In With the Right Crowd
First, the good news: The importance of statistics related to the way the world does business has never been greater. Now, the bad news: The statistician and quality professional might become the proverbial middle man who gets cut out by these advances....
Map Quest
Raytheon Six Sigma is a proprietary six-step process that Raytheon Co., a defense and aerospace systems supplier, has embedded into its culture. It was developed by an internal team that was guided by the company’s top leadership....

The Architect of Quality
Joseph M. Juran 1904 - 2008
Pioneer. Teacher. Consultant. Guru. Each of these words describes Joseph M. Juran, the man who became a giant in the world of quality management and changed how companies do business....

Sharp HealthCare Gets to the Point in Managing Diabetes
With literature from the last five years demonstrating that poor control of blood sugar in acute healthcare settings equates to negative outcomes in diabetics, Sharp HealthCare in San Diego decided to control it everywhere....
Standards Outlook: ISO 9001 and Advantage in the Marketplace
You have completed the ISO 9001 certification audit process and received an accredited certificate of registration from the registrar. Your organization has joined the nearly one million others around the world to achieve this distinction....

A Framework for Business Ethics
Profit maximization is, of course, the main and foremost objective for any commercial organization. Most modern organizations realize that to survive in today’s competitive arena, customers have to be satisfied....
A Gold Medal Solution
By using quality tools, a team from Boeing came up with solutions that eliminated the unsafe conditions that occurred during installation of the details in aircrafts' tailcones....
Quality in the First Person: Value of Certification
In 1986, I began my career as an engineer in the research and development function of a large global chemical company. Eight years later, my family relocated, and I took a job with a plastic products company as a senior process development engineer....
The Remedy for a Data Dilemma
In 1994, Bellin Health volunteered for a pilot assessment managed jointly by the Baldrige National Quality Program and the Joint Commission. This assessment helped Bellin focus on developing an integrated measurement system....
Expert Answers: March 2008
Outlook on outsourcing ... When does Six Sigma suffice?...

Efficiency Gets a New Identity
This article demonstrates the impact RFID will have on existing supply chain processes and the improvements RFID implementation will bring by comparing the benefits of RFID with those of barcode for various supply chain entities. The increases in data cap...
Launch to Quality
After using different quality methods with limited success, the Naval Surface Warfare Center, Indian Head Division, implemented lean Six Sigma in 2004. Through all of this, leadership demonstrated a steadfast commitment to fully implementing lean Six Sigm...
Expert Answers: February 2008
ISO standards outlines ... The benefits of kaizen blitzes....

Conflict and Complexity
Fourteen years before the space shuttle Challenger exploded shortly after launch in 1986, NASA unknowingly set in motion a series of events that culminated in the tragic disaster that stunned the proud space agency and rocked a nation....
3.4 Per Million: Forget Silver Bullets and Instant Pudding
There are no silver bullets or instant pudding waiting to be discovered. There never has been and never will be. This does not mean that there is not some level of benefit to be gained by an organization embracing Six Sigma, the new and improved...
A Less Costly Billing Process
Applying lean Six Sigma techniques can identify root causes, streamline the billing process and reduce errors. After describing the concepts of lean and Six Sigma, this article illustrates how companies can apply lean Six Sigma techniques to identify root...

One Good Idea: Compliance Requirement Matrix
From working in regulated industries over the years, I have seen plenty of quality system audits. Depending on the industry, noncompliant audit findings can be both embarrassing and costly....
Lean Lessons: Filling New Post-Lean Capacity
The impact of lean projects in manufacturing plants is more than cost efficiencies, decreases in lead times and improvements in on-time delivery....

One Good Idea: Compliance Requirement Matrix-Expanded Table
Compliance Requirement Matrix for Medical Device QSR of 21 CFR Part 820 (Abridged)....
Standards Outlook: Auto Industry Drives to Improve Healthcare
The U.S. auto industry has been challenged by its need to compete in a global marketplace while burdened by healthcare expenses for workers and retirees....
Eight Steps to Sustain Change
Improvement projects often focus on a problem, its measurement, analysis, and eventual solution, but fail to consider how improvements will be permanently integrated into the daily routine. Resistance is a natural response to change, but it can be...
Turbocharge Your Preventive Action System
A layered process audit (LPA) is an ongoing chain of simple verification checks to make sure a defined process is followed correctly. This powerful management tool can improve safety, quality and cost savings by amplifying problem solving systems and...

Achieve Compliance Through CI
Using Six Sigma tools for continuous improvement (CI) is a proven method for meeting or exceeding FDA requirements for medical devices. Optical Integrity Inc., a manufacturer of medical devices, used the Six Sigma define, measure, analyze, improve...
A Recipe for Safe Food: ISO 22000 and HACCP
Although food safety experts maintain that the U.S. food supply is one of the safest in the world, three recent food recalls raise the question of how food supplies can remain safe in a global environment. Hazard Analysis and Critical Control Point...
DFX and DFSS: How QFD Integrates Them
The differences in concept and application between design for excellence (DFX) and design for Six Sigma (DFSS) are discussed, and it is shown how they can be effectively integrated by using quality function deployment. Quality must be built into a...
ASQ Team Says QMS and EMS Standards Support SOX
The intent of the Sarbanes-Oxley Act (SOX) was to make the financial system of control more transparent and to reduce the incidence of corporate fraud. It soon became evident, however, that compliance with the law’s auditing requirements would be...

Agency Files Away Inefficiency, Saves Taxpayers a Bundle
Caseworkers for the SunCoast Region of the Florida Department of Children and Families won a silver medal in the 2007 International Team Excellence Competition by redesigning its paper based document filing and retrieval system and bringing it into...
Statistics Roundtable: When Should You Consider a Split-Plot Design?
Split-plot designs are an important, practical class of designs. When strategically chosen, split-plot designs can boost the amount of information a practitioner can extract from a designed experiment....

Army Aviation Depot Does an About Face
A few years ago the Corpus Christi Army Depot (CCAD), which provides maintenance, repair, and overhaul of the Air Force Pave Hawk helicopter, was in danger of losing the contract because of problems with turnaround time and cost overruns. CCAD’s...
Build Loyalty Through Experience Management
Connecting emotionally with customers requires an organization to create a total customer experience that differentiates the organization from the competition. This is important because customers’ overall experiences with the organization and the...
Standards Outlook: TL 9000 Measurements Handbook Release 4.0
The Quality Excellence for Suppliers of Telecommunications (QuEST) Forum is the global society dedicated to the quality of telecom products and services. The forum has developed and maintained a single common set of telecom...
Lean Lessons: Lean Kaizen in the 21st Century
Adapted from a chapter of Lean Kaizen, the author offers key takeaways from the Toyota Production System (TPS). He describes how the kaizen method is the foundation of the The Toyota Way and how it emphasizes efficiency, problem solving and...
Don't Throw Out the Baby With the Bath Water
Public school accountability prompted by the No Child Left Behind Act requires schools to assess the quality of educational delivery and make changes to assure student academic success, as well as establish a process for continual improvement....


