After you complete your risk assessment, you must then translate it into a risk profile. If your estimate of where your bribery risk is greatest is wrong, it will be an effort to address it. As Ben Locwin explained in his BioProcess International article, entitled “Quality Risk Assessment and Management Strategies for Biopharmaceutical Companies”:
Once we have assessed risks and determined a process that includes options to resolve and manage those risks whenever appropriate, then we can decide the level of resources with which to prioritize them. There always will be latent risks: those that we understand are there but that we cannot chase forever. But we need to make sure we have classified them correctly. With a good understanding of each of these, we are in a better position to speak about the quality of our businesses.
A way to evaluate risks as determined by the company’s risk assessment is through a risk matrix. Once risks are identified, they are then rated according to their significance and likelihood of occurring, and then plotted on a heat map to determine their priority. The most significant risks with the greatest likelihood of occurring are deemed the priority risks, which become the focus of your remedial efforts or for continuous auditing. A variety of solutions and tools can be used to manage these risks going forward, but the key step is to evaluate and rate these risks. All your actions should flow from the risk ranking.
Three key takeaways:
- Even after you complete your risk assessment, you must evaluate those risks for your company.
- The DOJ and SEC are looking for a well-reasoned approach on how you evaluate your risk.
- Create a risk matrix and rank your risks; then remediate and monitor as appropriate.
