I haven’t had formal experience with risk analysis, but from what I understand of the risk methodology is that it incorporate all cross functional teams within the products development. Whether if it’s marketing or R&D Engineering, the concept of Risk insures that uncertainty will not impact business goals. All potential risks should be addressed and reduced. I know from my experience within manufacturing, all aspects are taken into consideration when introducing a new process or introducing new equipment,but sometimes there is the occurrence of uncertainty that was not taken into account, as a result I’ve had experiences when we changed process, which is used for multiple products, but it drastically effected one of the products in a negative way, as a result manufacturing was halted to resolve the issue regarding that one product.

Chris