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.

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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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By: Oriel STAT A MATRIX

Medical device manufacturers may gain a one-year exemption from Food and Drug Administration (FDA) inspections if their establishment has been audited under one of the regulatory systems implemented by the Global Harmonization Task Force (GHTF) founding members using ISO 13485. Manufacturers must submit the audit results to the FDA voluntarily. From the audit results, the FDA determines whether to inspect that establishment for one year.

In a draft guidance issued on May 20, the “Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program,” the FDA describes how its Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research are implementing section 228 of the Food and Drug Administration Amendments Act of 2007.

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By: Oriel STAT A MATRIX

The status of nuclear power in the United States is finally changing. As of last month, there were 18 proposals under review by the Nuclear Regulatory Commission (NRC) for 28 new units in 14 states. This renewed interest in building nuclear power plants can be attributed in large part to the federal government’s commitment to nuclear power. It is expected that the renewed interest and ensuing construction of nuclear power plants will have a ripple effect of increased demand for support services and industries.

This is a dramatic change. Nuclear reactors generated only 20 percent of the electricity used in the United States in 2009—about the same percentage they generated in 1996, when the last commercial nuclear reactor came online in the country. However, during this same period nuclear power acquired a greater importance in other countries. According to the International Atomic Energy Agency, there are 17 countries that obtain a higher percentage of their energy from nuclear power than the United States does, including France (75%), Switzerland (39%), Sweden (37%), Japan (28%), and Germany (26%).

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By: Tom Pyzdek

In this four-part series, we take an in-depth look at how to design an effective work environment. Part one discusses the elements of continuous-flow work cells. Part two considers how to enhance the efficiency of such work cells. Part three explores the 5S methodology. In this, the last part of the series, we look at single-minute exchange of die (SMED).   

Changing from producing one part to another is an area worth special attention. This topic, like many in lean Six Sigma, is a big one. Many books have been written on the subject, so in this article, I’ll present a brief overview of the topic.

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By: LRQA Business Assurance

There is no doubt that the mixed and incomplete messages coming from regulators, markets, competitors, and stakeholders on how to address climate change make investment decisions for business more challenging and uncertain.

Nevertheless, many businesses are forging ahead with innovative and collaborative ways to reduce their greenhouse gas emissions, despite little clear direction on global emissions targets emerging from the UN Framework Convention on Climate Change (UNFCCC) Conference of Parties meeting that took place in Copenhagen in December 2009. This was the fifteenth meeting between the conference of parties (COP 15).

Some sectors with no global regulatory bodies are being proactive about making difficult decisions rather than waiting for a final global agreement from the regulators. These industries are designing and implementing energy-efficiency standards and emission-reduction strategies that will affect their activities around the globe.

This article looks at the climate change challenge for business and at what actions are being taken in the marine, aviation, and energy sectors.

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By: Regan Arndt

As the push to alternative energy technologies continues, the demand for photovoltaic modules is expected to increase exponentially. This article describes the specific performance tests found in IEC 61215:2005—“Crystalline silicon terrestrial photovoltaic (PV) modules—Design qualification and type approval,” and IEC 61646:2008—“Thin-film terrestrial photovoltaic (PV) modules—Design qualification and type approval.”

IEC 61215 and IEC 61646 set specific test sequences, conditions, and requirements for the design qualification of PV modules. Other standards address the safety qualifications for PV modules, including IEC 61730-1, IEC 61730-2, and UL 1703, and are outside the scope of this article.

Performance testing under IEC 61215 and IEC 61646 requires a total of eight test samples, selected at random from a production batch in accordance with IEC 60410. Figure 1 and figure 2 show the sequencing of individual tests under each standard. Individual samples progress through different test sequences in parallel.

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By: Andreas Petrosino

Brothers Jürgen and Andreas Hellgeth are entrepreneurs with a passion. Their interests, both business and leisure, center on motor sports and off-road vehicles. Their successful business designing and building off-road vehicles began by creating special vehicles for their own use. A converted racing Unimog with a twin-turbo, midmounted engine even secured them the overall winner’s spot in the Dresden-Breslau Rally in 2008 (see figure 1). Given their off-road expertise and a growing demand for individualized details and customized vehicle bodies, the Hellgeths have built up a business that has gained a good name among its customers.

The snowy forests and mountains surrounding their Wurzbach-Rodacherbrunn facility in southern Thüringen proved the perfect place for building all-terrain vehicles—the dozens of test tracks right on the doorstep are frequently used for product testing (see figure 2). Today, the family’s business activities focus on customized special solutions for wheeled vehicles and the modernization, conversion, and sale of tracked vehicles.

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By: Janice Tucker

When the Automotive Industry Action Group (AIAG) develops a new guideline or updates an existing one, it is often accompanied by the availability of new training. In the case of the second edition of Consumer-Centric Warranty Management Guideline: A Guideline for Industry Best Practices (product code CQI-14), the goal of the training is to develop practitioners well-versed in the tools provided in the manual to implement a warranty process that delivers best practices.

The best practices in the guideline have been developed based on the collective experiences of team members in the North American automotive original equipment manufacturer (OEM), light vehicle market. From General Motor Co.’s perspective, this project is an opportunity to be proactive within the value chain, working with OEMs, suppliers, and customers to identify and reduce warranty issues, and an opportunity to save billions of dollars in warranty cost. The benefit of industrywide training will accelerate the learning curve and more readily enable culture change.

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By: ANDREA LAHOUZE

John Berger is no stranger to the benefits of training within industry (TWI). In 1995, when Berger was working for global manufacturing giant Emerson, he was challenged to move an entire product line of electro-mechanical sensors from Minnesota to Singapore.

At Emerson’s Minnesota plant, processes for manufacturing the sensors were documented, but didn’t include the institutional knowledge needed for a successful technology transfer. There are three modules of TWI: job instruction, job methods, and job relations. The job methods and job instruction training helped employees at the Minnesota plant to better document their processes so they would have clear-cut procedures for the new Singapore employees. Once the product line arrived in Singapore, workers there used TWI to maintain and improve future procedures.

Berger credits TWI with much of the move’s success. “TWI adds the ‘what, how, and why’ elements into the procedure so that the operators understand what they’re supposed to do, how they’re supposed to do it, and why they’re doing it,” says Berger. “The ‘why’ part of things really helps them to get the quality aspects locked into their heads about why it is important to do something [a certain way], vs. taking a shortcut.”

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