The U.S. Department of Veterans Affairs Cooperative Studies Program (VACSP) Clinical Research Pharmacy Coordinating Center (the Center) is a federal government organization that supports multicenter clinical trials targeting current health issues for America’s veterans. Located in Albuquerque, New Mexico, the Center focuses on the pharmaceutical, safety, and regulatory aspects related to designing and implementing clinical trials conducted worldwide by the VACSP and other federal agencies and industries. The Center manufactures, packages, stores, labels, distributes, and tracks clinical trial materials (drugs and devices), and monitors patient safety. At any one time, the Center’s 112 employees provide products and services for approximately 70 clinical trials, which last from six months to more than a decade. During the past three years, the Center’s work benefited more than 90,000 patients per year at approximately 1,600 sites using nearly 300 drugs.

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few years ago a Missouri-based casting company, O’Fallon Casting, realized that its touch probe-based inspection system was stretched to the limit for most of its rapid prototyping work. O’Fallon Casting took a new approach by installing a cross scanner from Nikon Metrology plus PolyWorks software from InnovMetric Inc.

A prototyping project, involving the housing for an integrated wing-tip light of the Boeing 787 Dreamliner, illustrates the innovation of 3-D scanning and point cloud-based inspection. O’Fallon engineers inspected both the housing’s foam pattern and inherent aluminum part, and managed to cut the entire process throughput time by 50 percent. More important, the countless measurement points they had acquired and the CAD comparison analysis graphics enabled them to better supervise the process and eliminate prototype rounds while delivering top quality.

Under an indefinite delivery/indefinite quantity (IDIQ) contract with the U.S. General Services Administration’s (GSA) Great Lakes Region, Ghafari Associates LLC, a full-service architecture, engineering and consulting firm, was selected to design the restoration of the Chicago Federal Center (CFC) Plaza. The Federal Center was designed by Mies van der Rohe in the 1960s and is home to Alexander Calder’s steel sculpture, “The Flamingo.”

Principal buildings at the CFC include the 43 story, 1.2 million square foot John C. Kluczynski Federal Building and Loop Station Post Office as well as the 30 story, 1.4 million square foot Everett McKinley Dirksen U.S. Courthouse and several other buildings.

With the dawn of the new decade, retailers throughout the world are realizing the profit potential of going beyond their main channel of distribution and making products available through additional channels outside of their core competency. Overcoming the challenge of merging these different fulfillment channels—web, catalog, and brick-and-mortar—are the latest set of supply chain execution systems that create operational efficiencies via a single inventory process. The improved speed, accuracy, and ease of scalability of these systems yield significant cost savings and opportunities for business growth that can benefit any retailer of any size.

In the case of retailer Sur La Table—which operates 76 stores throughout the United States, as well as selling via catalog and the internet—its new supply chain execution system yielded accuracy improvement to 99.53 percent, a 20-percent increase in space utilization, and monthly reductions of $5,000 in energy costs and $2,000 in lift equipment rental fees.

Labor savings amounted to 18 percent with the new system. Given Sur La Table’s warehouse head count of 155 nonpeak employees and 300 peak employees, calculated efficiency gains after system implementation range between 34 and 66 full-time exempt staff.

The collapse of the global economy has put a lot of manufacturing companies out of business. Even at this late stage of the recession, there are still auctions of recently closed plants conducted every day. There are many more manufacturers struggling to reduce their operating costs and improve their profitability just to remain in business.

When the phrase “social network” comes to mind, people generally think about Facebook or Twitter. Volumes of academic studies have been written on this relatively new phenomenon.

But engineers who design such complex products as automobiles and airplanes have been operating within their own social networks—or specific patterns of communication—for a long time.

As with most patterns of communication, gaps are bound to occur. A recent study undertaken by operations expert Wallace Hopp and two colleagues describes such gaps in social networks as “coordination deficits.” Such deficits can be costly if not corrected.

“Based on what we hear from managers in the industry, about 60 percent of their quality problems are manufacturing-based and 40 percent are design-based,” says Hopp, the Herrick Professor of manufacturing at Ross. “We found that roughly 20 percent of those design problems can be traced to inadequate communication. This means that coordination problems are responsible for as many errors as individual mistakes by engineers. That’s very powerful information."

During the past six years, the Harrington Institute and its business partners have been involved in community improvement efforts that have produced significant results within the organizations involved. The thrust of the effort in the Orlando, Florida, community involved 25 projects and the certification of more than 300 Six Sigma Black Belts and Green Belts who worked on improvement projects involving a wide variety of community-based organizations—governmental, social services, and for-profits. The main focus of the projects has been on community improvement involving the at-risk population, such as children and families, seniors, and student outreach and participation organizations. All of the projects were performed on a pro bono basis with no cost to the organizations involved. The certifications were offered free of charge, and the cost of the materials was covered by local businesses and sponsors.

There were 10 different meta-themes involving the 25 projects in service organizations and government agencies that have been successfully completed since 2003:

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t is no secret that lean Six Sigma (LSS) and design for Six Sigma (DFSS) have arguably been the most effective initiatives for improving bottom line results and revenue growth since the advent of Frederick Taylor and management science. Billions of dollars in bottom-line impact have been documented by those companies implementing it seriously^{1, 2}. The synergy between the two methodologies is also well known as many companies use the savings from operational efficiency derived from LSS to fund their longer-term product development efforts via DFSS¹.

With today’s limited internal resources, it’s tough to transform machine maintenance from reactionary to preventive, and ultimately proactive, despite the obvious upsides in higher overall equipment efficiency (OEE), better process control, and lower total cost. Outsourcing this requirement to a third-party specialist, however, is a cost-effective alternative, according to companies that have crunched the numbers.

Manufacturers of all sizes—from single plant to multiplant and multinational—can benefit from outsourced maintenance to achieve world-class productivity and competitiveness. There are six primary areas where a single-source maintenance partner can optimize the capital investment and provide cost savings through lower total cost of ownership and increased return on investment.

Application support

Machine tool experts can analyze the tasks assigned to each machine and provide recommendations on process improvements, cycle-time reduction strategies, proper cutting tools, and work-holding configurations to optimize machine usage and performance, and reduce work in process, setup times and costs per part.

Where does the U.S. Food and Drug Administration (FDA) stand on good manufacturing practices (GMP), the set of regulations that govern manufacture and testing of medical devices and other medical products like pharmaceuticals, diagnostics, and food? And what of the universal device identification?

FDA regulations

Good manufacturing practices are, in general, a quality system that follows certain basic principles. These principles govern the manufacturing process, including the control and evaluation of process changes; the drafting of documentation, including instructions and procedures; the training of operators; the records of manufacture and distribution; and the handling of recall and complaint.

According to information from the FDA, “The current good manufacturing practices requirements set forth in the quality system (QS) regulation… require that domestic or foreign manufacturers have a quality system for the design and production of medical devices intended for commercial distribution in the United States.”