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The QA Pharm
Editor’s note: This is the second in a five-part series exploring issues that affect management’s ability to detect the warning signals of current good manufacturing practice (cGMP) compliance problems in the pharmaceutical industry.
In part one of this series, I discussed the management…
Matthew E. May
I was on my way to the market, shopping list in hand. “Honey, can you grab some lemons?” my wife called out as the door hit me on the bum. “Yep!” I shouted through the closed door. I hopped in my car, got to the store, whipped out my list, got everything on it, and headed home, feeling pretty darn…
Christine Schaefer
As a young child, I spent most Sundays visiting my paternal grandmother in a declining inner-city neighborhood of Detroit. By then, the city had already seen large-scale losses of middle-class residents. Many had fled to suburbs that offered better public schools, more reliable services, and safer…
Shaun Wissner
In the world of metrology, there has been a longstanding confusion regarding data management vs. data collection. According to the Data Management Association (DAMA), “data management is the development, execution, and supervision of plans, policies, programs, and practices that control, protect,…
NIST
American manufacturing is at a noteworthy and exciting convergence of three powerful trends that can provide an opportunity for growth in industry.
• Traditional manufacturing as we’ve known it may be fading, but there remains a legacy of innovation that can serve as a basis basis for future…
Lean Math With Mark Hamel
Work content (Wc) represents total operator cycle time or, if multiple operators are involved, the sum of operator cycle times to perform a specific process(es) or subprocess(es). The scope of human work, including both value-added and nonvalue-added activities, may encompass a complete value…
John Flaig
The claim is made and widely believed that C = 0 sampling plans are more cost effective than classic sampling plans such as ANSI/ASQ Z1.4. Below is a preliminary analysis of the cost difference between the two sampling plans using the hypergeometric probability distribution to compare a Squeglia C…
Sonal Sinha
Ever since the U.S. Securities and Exchange Commission (SEC) adopted Section 1502 of the Dodd-Frank Act, which requires publicly listed companies to disclose their use of conflict minerals, reactions to the new rule have been mixed. Major industry groups have filed legal challenges against the SEC…
Donald J. Wheeler
I recently read about a technique for analyzing data called the "Tukey control chart." Since Professor John Tukey is no longer with us, it appears that someone without his brilliance has tried to adapt one of his techniques into an alternative type of control chart. To understand the…
CMSC
(CMSC: Benbrook, TX ) -- The Coordinate Metrology Society announced today its 29th annual Coordinate Metrology Systems Conference (CMSC) attracted more than 500 professionals worldwide in the 3D portable measurement and inspection field. CMSC 2013 was held July 22-26, 2013 at the Sheraton San Diego…
Patrick Runkel
True confession: Nothing fires quickly from the top of my head—at least anything very lucid or useful.
To come up with a good idea, I have to dredge thoughts slowly from the thick sludge and sediment in my brain. It’s not always easy. There are deeply encrusted layers in my cerebral cortex that…
Mona K. Draper
Maersk Line is the largest container shipping company in the world. At any given time, its 500 vessels transport approximately 3 percent of the world's gross national product (GNP). In 2007, I walked into Maersk as a lean Six Sigma consultant looking for business and walked out with a job.
I saw…
Carly Barry
To promote ethical and moral responsibility in shaping its graduates, the Rose-Hulman Institute of Technology created a sustainability initiative to reduce its own environmental footprint.
As part of that team’s efforts, Six Sigma students at Rose-Hulman conducted a project to reduce food waste…
Meggitt
(Meggitt Sensing: Irvine, CA) -- Meggitt Sensing Systems, a Meggitt company and leader in sensing and monitoring systems for extreme environments, will be highlighting its Endevco line of sensors at the upcoming NIWeek conference Aug. 5–8, 2013, at the Austin, Texas, Convention Center.
The Meggitt…
Arun Hariharan
During the past dozen years, companies I have worked with have, between them, completed more than 1,000 lean Six Sigma (LSS) projects. Based on this experience, I’ve found that improvement projects can be broadly categorized into three types: quality-improvement, revenue-enhancing, and cost-saving…
NIST
Scientists at the National Institute of Standards and Technology (NIST) have developed a new standard reference material (SRM), the first such measurement tool to enable hospitals to link important tissue density measurements made by CAT scans to international standards.
Computed tomography (CT…
Jack Dunigan
My friend Steve is a horse whisperer, was one long before Robert Redford made the label famous. Steve’s been a cowboy forever, a genuine, sure ’nuff, tall-in-the-saddle, hand-me-that-rope cowboy. He knows his way around a horse, knows how to care for them, and knows how to handle them. If you’re…
Rip Stauffer
In one recent online forum, a Six Sigma Black Belt asked a question about validating samples—how to ensure that when they are taken, they would reflect (i.e., represent) the population parameter. His purpose: to understand the baseline for a project. He said he had six months of data regarding…
NICE Systems
(NICE: Ra'anana, Israel) -- NICE Systems, developer of analytic software, has announced that a benchmark study on trends and best practices in frontline performance management indicates that a majority of companies do not use collaboration and gamification to improve employee engagement. Only 12…
CRC Press
(CRC Press) -- Although Lean and Six Sigma appear to be quite different, when used together they have shown to deliver unprecedented improvements to quality and profitability. The Lean Six Sigma Black Belt Handbook: Tools and Methods for Process Acceleration explains how to integrate these…
Bruce Hamilton
For me, summertime is synonymous with a trip to the amusement park. I took my twins to Wonderland Park when they were just 4 years old, a déjà vu experience that transported me be back 50 years.
As my kids climbed onto the fire engine ride, I realized that this was the very same ride I had loved…
Margaret A. Hamburg
It’s a small world. Every day, there’s a good chance that some of the food you’re eating came from another country. Fifteen percent of the food we eat, including nearly 50 percent of the fresh fruit and 20 percent of vegetables, is imported each year.
That’s why it’s so important that we do…
Arun Hariharan
Detroit has become the largest city ever to go broke in the United States. Why? Because its industrial base withered in the face of global competition, and as the number of jobs dwindled, so did the city’s population.
This column isn’t about the specifics of the Detroit problem but about the role…
NIST
Researchers from the National Institute of Standards and Technology (NIST) and the University of North Carolina have demonstrated a new design for an instrument, a “instrumented nanoscale indenter,” that makes sensitive measurements of the mechanical properties of thin films—ranging from auto body…
Mark R. Hamel
Some folks may wonder what the heck I mean by “two types.” Within the context of a lean management system, we can make a distinction between visual process performance (VPP) and visual process adherence (VPA).
Visual process performance (VPP). These are typically metric-based visuals that provide…