What Makes You Tick?
Uncoordinated internal operations create organizational inefficiencies, a lower level of customer service and unnecessary delays in management decisions, resulting in increased costs....

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...

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?...

Back to Basics: Winning Them Over
You’re the new quality manager. You meet the management team and it seems committed to quality and fulfilling regulatory requirements. You’re relieved. Obtaining buy-in is half the battle....
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.”...
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?...
Standards Outlook: Confidence Game
For the second time in my 55 years on this Earth, we are seeing a crisis of confidence. This stems from many factors, including the devastating recession of 2008 to 2009 and the slow and painful global economic recovery we are witnessing....

One Good Idea: Form by Design
Filling out simple forms should be easy, right? Yet, how many of us have had the experience in which a simple and easy-to-follow form took more than one time to fill out 100% correctly?...

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....

Career Corner: Out of Hiding
While I was the senior statistician for a manufacturing division of a major aerospace firm, I shared the concept of the hidden factory with a statistical quality control (SQC) training class composed entirely of senior and middle management....

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...
Standards Outlook: Keeping Watch
Supply chain management is important to ensure organizations can compete in the global market. Organizations continue to focus on core competencies, resulting in greater dependence on high-quality materials and services from suppliers....
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....

Perspectives: The Unending Search
Recently, Stephen K. Hacker wrote that “many of our organizations remain mired in their current states, frozen in old mindsets.”...
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....

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....

Quality in the First Person: Failure of Inspection
Inspection often occurs at the end of the production line. As a result, the information gained from identifying problem pieces comes too late to make adjustments in the process, let alone isolate places in the process that are causing the problem....

Out in Front
“The job of management is not supervision, but leadership.” … “The aim of leadership should be to improve the performance of man and machine, to improve quality, to increase output, and to simultaneously bring pride of workmanship to people.”...
Statistics Roundtable: Follow the Rules
Despite appearances to the contrary, I am not old enough to have participated in the first discussions of control chart rules....
3.4 per Million: No Specification? No Problem
In a column earlier this year I referenced a nine-step approach for determining an organization’s long-lasting operational metrics and how to decide where to focus improvement efforts so the entire enterprise benefits....
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....
Get Them in the Game
The key to developing a high-performance, quality-oriented workforce is maintaining a high level of employee engagement....

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....
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....
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....

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.”...

Career Corner: Show Your Softer Side
There has been little attention and importance placed on softer skills. But more companies are realizing that while an individual’s hard skills will move them ahead quickly, it is the dearth of soft skills that can derail an individual’s advancement....
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....
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....
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....
Standards Outlook: Keep It Clean
Unfortunately, many organizations fail to adequately assess their overall facility environment, forget or are unaware of the need to ensure their buildings are clean and well-organized, and meet organizational and regulatory requirements....
(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....

Pointed in the Right Direction
Last November, ISO published a new edition of ISO 19011—Guidelines for Auditing Management Systems. This marks a further evolution in management system auditing and in ISO’s approach to the drafting of management system standards....
Expert Answers: September 2012
Sustaining excellence ... Blood bank error...
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....

Quality in the First Person: Shaping Your Life
When I graduated from Cairo University’s College of Pharmacy in 2006, I was full of hope and ready to hit the market. I imagined that organizations were waiting for me, ready to welcome me into their ranks....
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....
Follow the Signs
Many change models have been proposed, but one stands out: the transtheoretical model, also known as the health behavior change model. The model originates from directly observing how people really did or didn’t change in response to urgent medical needs....

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....
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....
Statistics Roundtable: Go With the Flow
Years ago, while on my way to conduct a statistical process control short course at a local ASQ meeting, I was stopped by a man who told me he had attended my short course the previous year and got a lot out of it....
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....

Back to Basics: Smart Charting
Control charts are at the foundation of Six Sigma. They serve as the primary tool to filter out the probable noise (inherent variation or common cause) from the potential signals (nonrandom variation or special cause)....
Innovation Imperative: Time for a Change
A quality manager’s career is far from predictable. It depends on the attitude of an organization’s leadership toward quality and, perhaps more importantly, leadership’s understanding of what quality is....
Expert Answers: June 2012
Continuous vs. discrete data ... Get IT under control ... You must measure ......
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....

Career Corner: Waiting for the Phone to Ring?
Whether you're employed or unemployed, if you are waiting for the phone to ring or for an email to arrive inviting you to explore a new job opportunity, you are awaiting a miracle. And we all know how often a miracle occurs....
Make the Leap
Kaizen events, also called kaizen blitzes or workshops, are intensive drives by dedicated teams of workers to fix broken processes or design new ones. They are arguably the best change vehicles in the organizational change fleet....

Tangled Mess
Many of the world's factories are designed in ways detrimental or unhealthy to product quality. The typically complex and lengthy flow times multiply process variables, which can obscure and delay the discovery of defects and nonconformities....
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....

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....
3.4 per Million: Next in Line
In quality, the sequel is what usually makes things better. Who knows how often savings have been left on the table because organizations failed to look ahead to the next project?...
Expert Answers: April 2012
The right way to roll out Six Sigma ... Dealing with troublesome auditees....

Career Corner: Should You Blow the Whistle?
Becoming a whistle-blower is no easy choice, even for quality professionals knowledgeable of organizational behavior and accustomed to audit processes with clear guidelines for nonconformance and corrective action....
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....

Perspectives: Theory of Evolution
Thumbing through W. Edward Deming’s timeless classic Out of the Crisis, it’s striking to see how the current economic crisis can be attributed to the factors he pointed out so many years ago as roadblocks to quality and productivity....
Eradicating Inconsistency
When most people imagine the Orkin man, they visualize a uniformed technician driving a white truck from house to house. What’s probably not as widely known is that the technicians stop at many places other than homes....
Rethinking Design
Design thinking offers several tools and concepts that can complement problem-solving approaches normally taught and used by quality professionals....

Back to Basics: Understanding Variation
Organizations with quality management systems compliant to ISO 9001:2008 are required to take action to eliminate the causes of nonconformities. If determination of variability type is absent from problem-solving methods, it leads to ineffective actions....
Measure for Measure: On Solid Ground
There are a few fundamentals every calibration or metrology department should know to get moving in the right direction....
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....
Get on Board
Although it is difficult to find a universally accepted definition of what it actually means, quality management is still the dream of every organization on the planet—or at least it should be....

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....
Expert Answers: February 2012
The best way to eliminate errors ... Adjusting to a new auditor....

Perspectives: Taken for Granted
The ISO 9000 series is Quality 101, and as quality practitioners, we should never forget it....
Online (Taylor)
Insights from developing a quality management and continuous improvement curriculum can be applied in an operations management context to teach quality principles to general management....
3.4 per Million: Inputs Into Action
A year ago, I wrote about the nine-step Integrated Enterprise Excellence (IEE) business management system and how it can be used to integrate voice of the customer (VOC) sources with other improvement efforts so an entire enterprise can benefit....
Lead On
In today's business environment, any organization that wishes to exceed customer expectations and stay competitive needs effective supplier management. Emotional intelligence plays an important role in dealing with suppliers....
Fail-Safe FMEA
The appropriate use of quality risk management can help organizations comply with regulatory requirements, such as good manufacturing practices or good laboratory practices....
3.4 per Million: The Way to Fail
Several months ago, I received a call from a lean Six Sigma leader from a large multinational organization who was concerned because his organization was having great difficulty completing projects....

Quality in the First Person: A Bad Sign
I kept my head down as I played hopscotch with the puddles on the mall parking lot. I started the engine, wiped some fog from the windows and started to back out, looking behind for cars. Suddenly—what was that?...
Expert Answers: December 2011
Survey struggles ... ISO 9001 vs. ISO 22000....
How Do You Compare?
Organizations often are unable to leverage benchmarking as a process to deliver excellence in business performance. This could be due to a lack of understanding of benchmarking as a process or lack of clarity on where it could add business value....
Statistics Roundtable: Use What You Know
Engineers and managers often must make important decisions in situations in which there is substantial uncertainty because of limited data. In some such cases, the data analyses can be bolstered by incorporating engineering knowledge and experience....
Standards Outlook: Know Your Role
When an organization has stale quality management system processes in the face of dynamic—at times chaotic— uncertainty, the entire system may become irrelevant....
Measure for Measure: True Meaning
The term “calibration” can mean different things to different people, depending on their education and experience, and whether they are suppliers or consumers of calibration services....

Back to Basics: Turning 'Who' Into 'How'
When things go wrong, the goal should be to move away from trying to determine “who” was at fault and quickly transition into a problem-solving mindset of “how” to make things better....
A Decade of Distinction
In the first six months of 2010, Telefónica Group launched 60 simultaneous quality improvement projects. These 60 projects represent nearly 30% of the total number of improvement projects conducted in the company during the last decade....
Expert Answers: October 2011
A QMS checklist ... Selecting a Six Sigma project ......
Standards Outlook: The Missing Link
In most organizations, quality and finance behave like independent silos, resulting in excessive costs and unhappy customers and investors....
Natural Selection
It is mind-boggling to find widely contradictory reports of improvement programs from companies using the same improvement methods. Executives don’t know what to believe. Two similar Six Sigma implementations can have two very different end results....
Online Tables Standards Outlook
Developed the following business process measures: 4 � documented results of management review meetings 5 � Customer satisfaction measures 5 � Measurable objectives used in product or service improvement 1 � balanced scorecard ( please indicate measures ...

Site Seeing
Assessing exposure to risk events and initiating proactive risk mitigation actions must be a priority of organizations worldwide. Fortunately, there’s a conceptual and methodical approach to conducting a risk-based quality audit....
Statistics Roundtable: Taking Stock
Recently, there has been exciting discussion about statistical engineering and its potential to redefine the role of statisticians and increase our influence in business through expanded participation in decision-making for high-impact problems....
Standards Outlook: How Will You Manage
While the required skill sets of quality and regulatory professionals constantly change, and capability upgrades must be ongoing to ensure success, it was hard to predict that branching out into project management would be the next hurdle....
Measure for Measure: Under the Microscope
Audits are chances to see where improvements can be made and to find areas that can be improved upon. If you approach an audit with the right mindset, it can be a great opportunity for all parties involved....
HU Goes There
After you've identified the root cause of a problem, what tool do you use to fix it? Enter a problem-correcting tool called the harmful/useful (HU) diagram....
The Right Stuff
The reality for many leaders is they are engaged in making decisions that affect everyone in the organization, but most of them have little evidence of whether decisions are being implemented as intended....


