Environmental Quality Corner with Ken Appel’s picture

By: Environmental Quality Corner with Ken Appel

On July 8, the Food and Drug Administration (FDA) announced an initiative “… to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the August 2003 Guidance for Industry Part 11, Electronic Records; Electronic Signatures—Scope and Application. (See the FDA announcement for details.)

What does this mean for pharmaceutical and medical device manufacturers?

First and foremost, the announcement means there is no time like now to reexamine how your company’s methods for creating, archiving, retrieving, and controlling data can potentially affect your products’ quality.

For example, many pharmaceutical companies should examine whether their data systems for controlled-environment monitoring provide full data accessibility (e.g., reports on raw data, necessary statistics, and graphs, whether generated automatically or on demand) and ensure tamper-proof content.

Walter Pastorius’s picture

By: Walter Pastorius

In sawmills, optimization is an in-process procedure that maximizes output of the highest-value board size and quality from the limited and environmentally valuable input of randomly shaped logs. During the optimization process, 3-D profiles of each raw board are analyzed before positioning saws. This way, each board can be optimally edged to exact width and trimmed to length, which removes defective areas and improves quality and productivity at the end of the line. When optimization is properly implemented, yields can improve by 15 percent or more. In a larger sawmill with a two-shift system, cutting an average of 80,000 board feet per shift, results in 40 million board feet (MMBF) per year. This means that an additional 15-percent yield improvement results in 6 MMBF per year. At $225 per thousand board feet (MBF), an impressive return of $1.35 million per year is possible.

By: Tess Woods

Since almost 70 percent of all changes in organizations fail, you might be interested in knowing why that’s so. Rick Maurer, author of Beyond the Wall of Resistance: Why 70% of Changes Still Fail and What You Can Do About It, Revised Edition (Bard Press, 2010), put together his top 10 list in the spirit of David Letterman.

10. Some leaders don’t know how to lead change. Unless you are a brand new manager or have been living in a windowless cellar for the past 20 years, you’ve undoubtedly been exposed to change management. You’ve read a couple of books, attended training, heard motivational speakers, and been subjected to consultants who tout their brand of change management. As a result, most leaders know what to do—but they don’t put that knowledge into practice.

9. Leaders assume that change is easy. They expect people to add a new project to their already full plate of activities. When these leaders are asked, “What’s the top priority now?” they reply, “Everything.”

Dirk Dusharme @ Quality Digest’s picture

By: Dirk Dusharme @ Quality Digest

A dish-style radio telescope is being constructed in China that will allow astronomers to detect galaxies and pulsars at unprecedented distances. Not only will the Five-hundred-meter Aperture Spherical Telescope (FAST) be almost 200 meters larger than the current largest telescope in the world, it will be the only telescope of its kind with the ability to change shape and move the position of its focus. The dimension of the telescope, once completed, will be equal to 30 standard football fields, making FAST the biggest telescope in the world. The sensitivity will be 10 times better than the 100 m telescope in Bonn Germany, and the comprehensive performance will be 10 times better than Arecibo 300 in America.

As shown below, the Karst depression in the Guizhou province of China provides a unique topographical condition ideal for building the FAST.

Figure 1: Artist rendition of FAST installed in Karst depression. The feed cabin is the purple object in the middle.

Jay Elepano’s picture

By: Jay Elepano

For decades we were taught to believe that if you ever wanted to measure anything properly, you needed a coordinate measuring machine (CMM). A couple of decades ago, portable arms were released and although they were novel, nothing could compare to the rigidity and accuracy of three linear scales and drives. We were resigned to the fact that any improvement in CMMs would be only incremental. We lived this way for decades. Recently, however, optical CMMs began developing and maturing, to the point that they may have become the revolutionary change the metrology market is looking for.

About the optical CMM technology

While the technology comes in different “flavors,” most optical CMMs work around a similar principal. For instance, Nikon Metrology’s optical CMM (KCMM) begins with three linear CCD cameras. When light from an active LED is detected, the three cameras triangulate its position in space.

Richard Lepsinger’s picture

By: Richard Lepsinger

This three-part series about strategy and its execution is based on Richard Lepsinger’s book, Closing the Execution Gap: How Great Leaders and Their Companies Get Results (Jossey-Bass/A. Wiley, 2010). Part one defines the “five bridges” that companies can use to close the gap; part two describes how to build the bridges; this final part highlights successful companies that have bridged the gap.

Ever wonder why some companies consistently meet their goals and others don’t? So did I, and it was to find out why that my consulting firm conducted a study of 400 companies. We discovered that there are five factors that set apart the organizations with the best performance results and those more effective at execution. I think of them as "The Five Bridges" because they help companies close the gap between strategy and execution. To see what the bridges look like in action, let's take a look at a handful of well-known companies that execute exceptionally well:

Richard Lepsinger’s picture

By: Richard Lepsinger

This three-part series about strategy and its execution is based on Richard Lepsinger’s book, Closing the Execution Gap: How Great Leaders and Their Companies Get Results (Jossey-Bass/A Wiley Imprint, 2010). Part one defines the “five bridges” that companies can use to close the gap; part two describes how to build the bridges; and part three highlights successful companies that have bridged the gap.

If you read part one of this series, you're now familiar with the “five bridges” that enable a company to execute well. But how do you go about building them? First, you get comfortable with the fact that it’s a never-ending process. Then, you put certain time-tested tools and techniques in place and implement them relentlessly. The following, excerpted from Closing the Execution Gap, are some of my favorite tricks of the trade for getting these bridges underway.

Montserrat Capellas Espuny’s default image

By: Montserrat Capellas Espuny

X-ray fluorescence spectrometry was done directly on the paintings in the Louvre Museum.

Copyright: V.A. Solé/ESRF

How did Leonardo da Vinci manage to paint such perfect faces? For the first time a quantitative chemical analysis has been done on seven paintings by da Vinci directly in the rooms of the Louvre Museum without extracting any samples. The analysis identifies the composition and thickness of each layer of material laid down by the painter. The results reveal that, in the case of glazes, thin layers of 1 to 2 micrometers have been applied. The study, led by Philippe Walter and a team from the Laboratoire du Centre de Recherche et de Restauration des Musées de France, with the collaboration of the European Synchrotron Radiation Facility (ESRF) and the support of the Louvre Museum, was published July 15 in the journal Angewandte Chemie, International Edition.

By: Andrea Redmond and Patricia Crisafulli

When setbacks happen, vulnerability often follows. Feeling unprotected and exposed, we don’t want people to know what we’re facing, whether it’s a professional upset such as the loss of a job, loss of a great sales account, or being passed over for promotion, or something more personal. The more upsetting the circumstances, the more we may fear what other people think and say about us. Not only are we concerned about the opinions of our friends and work associates, we can become preoccupied with what “they”—the people beyond our scope of influence—think.

For people who tend to be more relationship-oriented by nature, the effects of setbacks may be even more difficult to deal with. Suddenly, despite your accomplishments and professional standing, everyone’s opinion matters. We become so preoccupied by other people that we invest too much precious time and energy trying to manage opinions and perceptions, and not focusing on how we can effectively deal with the problem at hand.

Jack Healy’s picture

By: Jack Healy

Economies shift in response to changes in financial power, and these changes will always affect our world. News reports about the strikes and labor problems in several Chinese manufacturing plants highlight the challenge the Chinese government faces in maintaining an economy based on cheap labor and exports. Although such an economy is not sustainable in the long run, it has served China during its industrial development phase. However, China’s manufacturing base has been evolving since the government completely revised its labor laws. These changes, along with the currency appreciation of the yuan and stricter enforcement of environmental legislation, have caused China to signal it is no longer interested in low-value production. Although the recent strikes and labor unrest have certainly contributed to this change, they aren’t the sole cause of it. China is increasing its manufacturing momentum to draw alongside and possibly overtake some of its global competitors. The fallout from this is just beginning.

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