March 2011 Posts

The Impact of SOX on Quality

The Impact of SOX on Quality

Risk is a subject prone to irrationality. We worry about mere possibilities. We ignore probabilities. We focus on perception. We ignore reality. Twenty percent of adults still smoke. Twenty percent of drivers still don’t wear seat belts. Two-thirds of the population is overweight/obese.

Risk is everywhere: market risks, operational risks, business risks, strategic risks, financial risks, environmental risks, etc. It’s too easy to think, “It’ll never happen to me” and ignore risks. Designing a solid risk management model requires attention to all risk areas. (more…)

Is the FDA Keeping the U.S. from Innovation?

Is the FDA Keeping the U.S. from Innovation?

This past January, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) announced its plan of action for implementation of its 510(k) and science recommendations. Under section 510(k) of the Act, announced in August 2010, a person who intends to introduce a device into commercial distribution is required to submit a premarket notification, or 510(k), to FDA at least 90 days before commercial distribution is to begin.  While safety is at the core of this regulation, is it also limiting the possibilities for innovation and delivering products to market? (more…)

Managing Quality, Compliance and Risk in a Global Economy

Managing Quality, Compliance and Risk in a Global Economy

Time to market is one of the major reasons we look to the global economy. Acquisitions and mergers can take us across international borders to quickly gain the intellectual property we need. International supplier sourcing can get products more quickly to our manufacturing sites and our customers, or broaden our foot print in a country quicker and faster. (more…)