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.
William C. Athanas, in his Industry Week article, “Rethinking FCPA Compliance Strategies in a New Era of Enforcement”, posited that companies assume that FCPA violations follow a bell curve in which most employees are responsible for most of the violations. However, Athanas believed that the distribution pattern more closely follows a hockey-stick distribution, where virtually all violations are committed by just a few people. Athanas concluded by noting that is this limited group of employees, or what he terms the “shaft of the hockey-stick,” to which a company should devote the majority of its compliance resources. With a proper risk assessment, a company can then focus its compliance efforts such as intensive training sessions or detailed analysis of key financial transactions involving those employees with the greatest means and motive to commit a violation.
The most significant risks with the greatest likelihood of occurring are deemed to be the priority risks. These become the focus of your most significant risk management efforts, couple with audit and monitoring going forward. A variety of tools can be used to continuously monitoring risk going forward. Consider providing employees with substantive training to guard against the most significant risks coming to pass and to keep the key messages fresh and top of mind. It is important to create a risk control summary that succinctly documents the nature of the risk and the actions taken to mitigate it. Finally, let this risk assessment and evaluation inform your compliance program, rather than letting the compliance program inform the risk assessment.
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.
