If you are buying two or three complex assemblies per month from a contract manufacturer, it would be reasonable to check every one carefully; there’s a lot that could go wrong. However, if you are buying 100,000 simple subassemblies per month it makes no sense for you to 100-percent check them and probably isn’t practical anyway; life is too short, costs are too high.

So how do you inspect or test products when 100-percent checking is impractical?

My first suggestion is to get someone else to do it. Ask your supplier to do the checking and provide evidence to you that they have done so. Beyond that, you or your suppliers could use a sampling plan. This works on the basis that you inspect or test a defined number of samples from each delivered batch, and if more than a fixed number of these units pass then you accept the whole batch. If fewer than that number pass you reject the whole batch or, at least, require that the batch is entirely checked.

It sounds obvious, and you may already be doing it, but how do you choose the batch size and the pass/fail numbers to be statistically valid?

The FDA’s Center for Devices and Radiological Health (CDRH) posted a notice of draft guidance that will require all medical device adverse-event reports to be submitted electronically. While the process of electronic submission of data is a more efficient and traceable means for reporting, it could prove to be a very long and challenging road for the average medical device manufacturer to transition from its current paper-based reporting process to an electronic reporting process.

To ensure success, this transition needs to be very carefully planned out and executed to guarantee continued compliance and ongoing integrity with regard to the company’s product adverse-event reporting and customer satisfaction.

(NIST: Gaithersburg, MD) -- Finally, an optical frequency comb that visibly lives up to its name.

Scientists at the University of Konstanz in Germany and the National Institute of Standards and Technology (NIST) in the United States have built the first optical frequency comb—a tool for precisely measuring different frequencies of visible light—that actually looks like a comb.

Product certifications have exploded in recent years. Products ranging from pine lumber to children’s toys carry some sort of certification, and the organizations issuing certifications are as diverse as the products themselves. What are the practical values of these certifications? What are the pitfalls and limitations? In this article I will explore these issues and propose some recommendations for a product certification program that is meaningful and helpful to consumers and producers alike.

The changing marketplace

The variety and sophistication of products that are available to the general public has exploded in the last half century. Products that would have been considered extravagant or even unimaginable are now commonplace, available day or night at the local big-box retailer, or delivered by a brown UPS truck. Automation of manufacturing methods and the reduction of variability have driven down product costs, and improvements in logistics have moved products to consumers in every corner of the world. The range of manufactured goods has never been broader or more impressive.

Recently released labor market, manufacturing, and consumer data indicate an economy steadily emerging from the long recession. One of the most gratifying indications of this change was the Associated Industries of Massachusetts Business Confidence index showing a continued gain of 1.8 points in September for an overall business confidence level of 42.4 (the highest since September 2008).

AIM Business Confidence Survey

Despite the changes, confidence levels in manufacturing have not returned to the point where there is a general belief that the current improvement is permanent, at least for manufacturers in New England.

(Georgia Tech Enterprise Innovation Institute: Atlanta) -- Debbie Guzman, laboratory director at Athens Regional Medical Center, says that implementing lean principles in a health care setting is especially challenging. Traditionally used in manufacturing, lean refers to an operational strategy derived from the Toyota Production System that focuses on eliminating waste while increasing value-added work to improve profitability, customer satisfaction, throughput time, and employee morale.

“People involved in health care are about hands-on care giving, comforting, and healing,” she says. “We needed someone to help us who understood our language.”

For enhancement efforts, Six Sigma offers statistical and nonstatistical analysis techniques that aid in the identification of where and how to improve processes. In contrast, lean focuses on the reduction of waste in overproduction, waiting, transportation, inventory, over-processing, motion, and defects.

ABB of Västerås, Sweden, is a pioneer among world industrial robot manufacturers when it comes to using laser-based measuring technology to ensure robot precision. ABB, with an installed base of 125,000 robots, stands out as the world’s largest in the arena of industrial automation. And Leica Geosystems’ equipment is instrumental in a unique calibration method that offers customers exact robot positioning accuracy throughout the entire life cycle of their robots.

As Europe sets ambitious targets for energy that is clean and inexhaustible, wind energy is predicted to meet approximately 25 percent of Europe’s power demand within 25 years. Today’s wind turbines measure 70–150 meters and feature bladed rotor diameters of 100 meters or more, translating into a swept air area of 8,000–10,000 square meters. Wind turbines convert wind power into bladed rotor mechanical torque and subsequently into 1.5 to 4 MW of electrical power.

Figure 1: When standing in front of a wind turbine, its impressive size
is striking.

(NCQA: Washington) -- “The State of Health Care Quality 2009,” an annual report, now in its 13th year, provided by the National Committee for Quality Assurance (NCQA), finds that the quality of U.S. health care was virtually stagnant in 2008, a disturbing slowdown after a decade of improvements. The across-the-board trend was seen in care provided to people with private insurance coverage as well as in Medicare and Medicaid. The report also examines the link between higher health care spending and quality and finds little to no connection, a finding with significant implications for health care reform efforts.

“As Congress works to shape a final health reform bill, lawmakers must be certain that the legislation includes significant provisions to improve the quality and efficiency of care,” says NCQA president Margaret E. O’Kane. “This includes requiring quality reporting by all health plans and providers, not just those who do so voluntarily today.”