Finally, the long and arduous process that appears to be a requisite phase in the development of an international quality management system standard appears to be nearing an end. Though the AS9100:2009 and AS9101:2009 (checklist) have been available for quite some time, the aerospace industry has anxiously been awaiting the release of AS9104, the final document to complete the trilogy of aerospace standards.

Even though this standard is the least well-known to most people in the aerospace industry, its importance cannot be overlooked. AS9104 is actually made up of three standards: AS9104-1, AS9104-2, and AS9104-3. Combined, they provide the structure that accreditation bodies such as ANSI-ASQ National Accreditation Board (ANAB), and certification bodies such as National Quality Assurance (NQA), need to carry out effective certification audits. They also include requirements that affect almost every decision your certification body (CB) makes.

Editor's note: In this first in a series of articles on workplace visuality, Gwendolyn Galsworth, Ph.D., author of Work That Makes Sense (Visual Lean Enterprise Press, 2010)  and Visual Workplace/Visual Thinking (Visual-Lean Enterprise Press, 2005), and recognized visual expert, sets out the basic concepts and definitions of this powerful adherence and empowerment approach.

The entire world of work—whether assembly plant, hospital, bank, airport, military depot or pharmaceutical factory—is striving to make work safe; simpler; more logical, reliable, and linked; and less costly. Central to this is the visual workplace.

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.

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.

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.”

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.

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.

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:

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.

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.