FDA?s risk-based approach: old concept or new philosophy?

In the framework of its cGMPs for the 21st Century (09/04) initiative, FDA has made a risk-based approach its new guideline ? meaning that every quality assurance system must be governed by consistent risk management. This position is clear; however, what is not clear for many companies are the practical consequences for validation. So what will the changes be from now on, when a risk-based approach is going to be the focus of validation? Is there more to it than just a new label for a long-standing method?