@Risk

The US Pharmacopeial Convention (USP) has proposed a set of recommended best practices to help the pharmaceutical industry improve supply chain integrity and reduce risks of counterfeit or mishandled medicines.

Improvements like these are long overdue. As I reported last spring, research from PwC concluded that many pharmaceutical supply chains have suffered from what amounts to benign neglect. As a result, they are inefficient, under-utilized and ill-equipped to cope with new medicines, cost pressures and health reform expectations.

Sure, in today’s global economy relationships between suppliers and other business entities are often opaque and difficult to track, but clearly, it’s time for the pharmaceutical industry to step up to better ensure that medicines can be traced back to their original manufacturer, are not adulterated or counterfeited and are transported to their intended destination with their quality intact.

Too many companies have discovered the hard way that “willful blindness” only increases their culpability in the eyes of Federal agents, regulators who now are cracking down on businesses that aren’t compliant with the Foreign Corrupt Practices Act (FCPA).

Don’t take that kind of risk. Resolve that this is the year to start better managing your multiple supplier master databases as you monitor and mitigate supplier risk in a global operating arena.

“There is incentive for all players in the pharmaceutical industry—large and small companies, regulators and standards-setting bodies—to come to some agreement on hotbutton issues such as track and trace technology and, at the larger level, to codify what constitutes a solid, universal approach to global supply chain integrity,” said Praveen Tyle, Ph.D., chief science officer for USP.

USP’s proposed standard covers four main areas: (more…)

The global automotive industry is poised for continued growth in 2012, provided the European Union gets a handle on the debt crisis there.

In an announcement last week, PwC’s automotive analyst group, Autofacts, said that it expects 2012 global light vehicle assembly will exceed 79 million units, an increase of 6.8 percent from 2011’s total.

According to Autofacts, there are many factors contributing to the positive outlook. For instance:

• Local demand in the BRIC marketplace is on the rise. Monetary tightening and other policy shifts in Brazil, India and China caused slower growth in 2011. But, as PwC points out, inflationary fears in these markets are subsiding –prompting correspondingly looser monetary policy –and these markets could be poised for substantial growth once again. Russia is positioned for another year of strong local demand. Autofacts forecasts BRIC growth is likely to reach double digits (12 percent) in 2012 following only five percent growth in 2011. (more…)

Several materials used in the manufacture of clean energy technologies such as wind turbines, electric vehicles, solar cells and energy-efficient lighting are at risk of supply disruptions in the short term, according to a new report released by the US Department of Energy (DOE).

The 2011 Critical Materials Strategy is DOE’s second report on this topic and provides an update to last year’s analysis. After its analysis, the DOE has concluded that:

• Supply challenges for five rare earth elements (REEs) (dysprosium, neodymium, terbium, europium and yttrium) may affect clean energy technology deployment in the years ahead.
• The risks of supply disruptions in the short term will generally decrease in the medium and long term.

The report also includes a discussion of DOE’s strategy to address these critical materials challenges. DOES says its strategy rests on three pillars: (more…)

Rising labor costs and quality concerns have many US companies reevaluating their overseas strategies.

In fact, new research conducted by Cook Associates Executive Search found that a full 85 percent of manufacturing executives see the possibility of  certain manufacturing operations returning to the US.

What are the reasons for this potential shift? Survey participants cited:

• overseas costs (37 percent)
• logistics (19 percent)
• other, including economic/political issues, quality and safety concerns, patriotism and overseas skills shortages for highly technical manufacturing processes (36 percent)

The study, which polled nearly 3,000 manufacturing executives primarily in small- to mid-sized US companies from October 13 through November 18, 2011, identified low-volume, high-precision, high-mix operations, automated manufacturing and engineered products requiring technology improvements or innovation as the primary forms of manufacturing returning to the US. (more…)

Commercial transportation fleet owners need to better screen and qualify drivers in order to ensure compliance with new federal initiatives, according to the LexisNexis 2011 Commercial Driver Safety Report released last week.

The study revealed several troubling trends indicating a growing gap between compliance and safety programs.  For instance, the research found that commercial driver applications with incomplete or inaccurate information increased 20 percent in 2011, reaching 31.42 percent, up from 11.78 percent in 2010.

In addition, commercial drivers’ motor vehicle reports (MVRs) with adverse findings, which can indicate one or more violations (such as a revoked license), are consistently increasing steadily year after year –rising from 48.2 percent in 2008 to 50.33 percent in 2011.

And, with regard to drug testing: (more…)