This week I have devoted my blog posts to thinking about the management of risk by considering the tools of forecasting, risk assessment and risk-based monitoring. I have been assisted on this journey by Ben Locwin, Director of Global R&D at BioGen and an operational strategist in pharma and healthcare, to explore risk forecast, risk assessment and risk monitoring for the compliance profession. Today I want to tie it all together by asking the question So What?
I think there are several key lessons to be considered by any Chief Compliance Officer (CCO) or compliance practitioner. The first is the process around risk management. Most compliance practitioners understand the need for a risk assessment as it is articulated as Hallmark No. 4 of the Ten Hallmarks of an Effective Compliance Program. From the FCPA Guidance, the Department of Justice (DOJ) and Securities and Exchange Commission (SEC) said, “Assessment of risk is fundamental to developing a strong compliance program, and is another factor DOJ and SEC evaluate when assessing a company’s compliance program.” In addition to this business case, the FCPA Guidance also specified the enforcement reasons for performing a risk assessment, “DOJ and SEC will give meaningful credit to a company that implements in good faith a comprehensive, risk-based compliance program, even if that program does not prevent an infraction in a low risk area because greater attention and resources had been devoted to a higher risk area.”
Yet as compliance evolves and corporate compliance programs become more sophisticated, compliance is seen not as simply a legal prophylactic, but as a business process. Seen in this light, it is clear the risk management process should begin with forecasting as it attempts to estimate future aspects of your business. Locwin noted that companies should be able to say with some degree of authority, “We think the following will happen in the next three months, six months, twelve months, twenty-four months, is really something that the businesses try to wrap their heads around in such a way that they can shunt resources where they think is appropriate in order to meet these future demands.”
By starting with forecasting, a compliance function utilizes risk assessment to consider issues which forecasting did not predict for or issues which the forecasting model raised as a potential outcome which warranted a deeper dive. If you are moving into a new product or sales area and are required to use third-party sales agents, a risk assessment would provide information that a company could use to ameliorate the risks.
Risk-based monitoring follows on from the issues that your risk assessment identified as your highest risks. Locwin said, “Risk-based monitoring tends to look at things 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.”
All of these three tools tie back into process management and process improvement. Locwin stated, “There’s always this balance between what’s actually important for our business or for proper execution, versus what’s actually going on in the whole process. If you’re not measuring at a high enough resolution, you’re not capturing a lot of the environmental, market force, external factors that probably are of high leverage to your operations in business that you just don’t know about.”
Locwin tied them together with the following example, “There’s a 30% chance of this abject market failure happening, this product fails, this restaurant site contaminates people, this product doesn’t ship before Christmas, this phone explodes.” If you knew that in advance, the executive committee probably almost everywhere would say, “We have to act, and act now.” That’s where the rubber meets the road and you’ve got to forecast and a contingency in place. A lot of times, there isn’t that level of forecasting done in advance to say, “We think there’s this 30% chance of it occurring, therefore not only do we need a strong contingency plan, but we should expect to have to use it in Quarter 2. It’s right there sitting on everybody’s dashboard all the time.”
In other words, it comes down to, as Jay Martin would say, execution. This means you have to use the risk management tools available to you and when a situation arises, you remediate when required. This is not only where the rubber hits the road but the information and data you garner in the execution phase should be fed back into process loop. From this, you will develop continuous feedback and continuous improvement.
I have gone through this in some detail to emphasize the business process nature that compliance has evolved into as a corporate discipline. By using these techniques, the CCO or compliance practitioner makes the business run more efficiently and at the end of the day, more profitably. The more you can bring these types of insight to a Chief Executive, the more you demonstrate how compliance adds to the bottom line and is not simply a cost center.
Ben Locwin is a healthcare expert who is frequently featured in the popular media. He gives speeches internationally and specifically has written about the forecasting, assessment and monitoring of risk in the life sciences industry. He has also taught risk management and modeling at universities and to top Fortune 500 companies in automotive, aerospace, food & beverage, pharma, and other industries. He can be reached at ben.locwin@HealthcareScienceAdvisors.com.
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