Another mechanism for continuous improvement of your compliance program is through risk-based monitoring. Under Prong 5 of the DOJ’s Evaluation of Corporate Compliance Programs, is the following topic and question Manifested RisksHow has the company’s risk assessment process accounted for manifested risks? I found this to focus as much on continuous improvement, as it did with risk assessment through the emphasis on the risks which have been established and demonstrated by the organization. In other words, were you monitoring the risk that you have not only identified but also have revealed themselves to your organization.

I visited with Ben Locwin, Director of Global R&D at BioGen and an operational strategist in pharma and healthcare, to consider risk-based monitoring and how it helps to facilitate continuous improvement in a compliance program. Locwin said, “Risk-based monitoring is really about continuous, ongoing monitoring for those things which provide the most potential future risk to you. In other words, instead of a static risk registry that may come in part with forecasting, where you would say, “We’re trying to anticipate these risks.” By using risk-based monitoring to review issues on an ongoing basis, and the models that are behind the risk-based modeling, risk-based monitoring models, they’re continuously refined based on incoming data.”

The problem for many companies is they are siloed in not only their data but also in the systems. Locwin explained that because of the disparity of data systems, “They may not be tracking rigorous, quantified information all the time.” He cited to an example from the pharmaceutical world where a company could well have 50 worldwide sites where a drug product is being tested. Some patients receive a placebo and some patients receive the medication being tested. As data comes in you begin to note patterns in certain patients and groups, which might actually point towards a variety of testing errors by physicians administering the test.

Through the use of risk-based monitoring, you can begin to see things in “almost real-time, time-based trends of real data that you can then jump on and try to make adjustments before things get really wacky.” The implications to the compliance practitioner? Having access to information around sales, the sales process and corporate largess in things from Corporate Social Responsibility (CSR) work to gifts, travel and entertainment to conferences for customers and end users. Through the use of such risked-based monitoring a compliance professional would have the opportunity see trends developing which could allow an intervention for a prescriptive solution which could prevent an issue from becoming a Foreign Corrupt Practices Act (FCPA) violation.

Yet Locwin cautioned that compliance professionals should guard against bias. In an article by Locwin, entitled “Be Careful When Appraising Industry Trends”, he stated, “Social media has rapidly accelerated the agility with which the public can change allegiance and direction. It used to be that when information dissemination was slower and more compartmentalized within regions and market segments, that the market resistance to fluctuation was more robust. Now well-placed advertising, social commentary, or public response to corporate missteps can swirl into a maelstrom of market changes within hours that is agnostic to region or market segment.”

In today’s world, the speed at which reputational damage reigns out can overwhelm a corporation’s ability to respond. Here one might consider Wells Fargo and how fast the situation spun out of control for them after its $185MM fine was announced. It is through the use of risk-based monitoring, which allows for this almost real-time input, that a response to a forecasted, assessed or even unassessed risk can be developed. In the compliance world, such tools could be brought to bear when considering not only the expense side of such areas as gifts, travel and entertainment but also sales side data. This could be internal company data on its own salesforce and also information developed from or concerning your third-party sales team.

In Locwin’s primary world of pharmaceutical testing and product development, the need for such real-time information can be more critical. Yet through the development of these techniques as compliance tools, the compliance profession can add value to an organization through the use of risk-based monitoring. With the plethora of data on where and how corruption is likely to occur, coupled with meaningful sales and expense data, the compliance professional should be able to move from detect to prevent to prescriptive compliance solutions to prevent legal violations.

Finally, the beauty of all these techniques articulated by Locwin is that they are tools that can make companies more efficient and, at the end of the day, more profitable. They also move compliance into the fabric and DNA of an organization or in the words of Hui Chen, the former DOJ Compliance Counsel, operationalize compliance. Her intonation to operationalize compliance speaks use of a wide variety of tools to input information so you can continuously improve your compliance program. Risk-based monitoring is certainly one mechanism to obtain information and feed it back into your compliance program in both the prevent and detect prongs.

Three Key Takeaways 

  1. How do you monitor manifested risks?
  2. A risk-based monitoring approach allows you to see things in almost real-time.
  3. Management of risk can serve your compliance program in a variety of ways.

 

For more information on how an independent monitor can help improve your company’s ethics and compliance program, visit this month’s sponsor Affiliated Monitors at www.affiliatedmonitors.com.

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