Life Science Compliance Effectiveness

Life Science Compliance Effectiveness

Our last post used a toy brick analogy to show how compliance effectiveness, efficiency, and affordability can be achieved by simplifying compliance programs (as opposed to adding to them). But there can be a fine line between simplifying a compliance program and sacrificing it.

Let’s return to our toy brick analogy where:1) the tower represents a compliance program, and the bricks represent the pieces of the program (e.g., policies, procedures, trainings, monitoring, auditing, etc.)2) the tower needs to safely support an ever-increasing pile of weight plates, which represent the growing body of state and federal laws, regulations, agency guidance, enforcement actions, etc.3) the dog represents us (compliance teams/professionals).As long as our tower is stable and strong, we don’t need to worry. But if we take away too many bricks (or the wrong bricks) when we design, build, or refine a compliance program, then our tower could weaken or crumble. So:-over-engineered = effective, but inefficient/expensive;-too bare-bones = simple and efficient, but ineffective.

If you’re just starting to design/build your compliance program, use your bricks intentionally: focus on a strong base that can be added to as compliance requirements increase as your company grows/matures. If you already have a compliance program, routinely evaluate how it can be streamlined and simplified without sacrificing effectiveness.

In either case, we recommend the questions/metrics below to help measure the efficiency/simplicity of your compliance program (we’ll cover effectiveness in a later post):-how many policies, procedures, trainings, monitoring activities, audits, etc. do you have, and how much time do they take to track, complete, and monitor?-what is your compliance budget/spend each year (include external expenditures and fully-burdened internal FTEs)?-how many compliance vendors, systems, portals, etc., do you use?-how many compliance officer/committee exceptions, escalations, or approvals do you have each quarter?-how much time does the compliance team spend each month performing tasks that don’t require compliance expertise, training, and analytical skills?-how do non-compliance colleagues feel about the compliance program: easy-to-understand and helpful, or complicated and cumbersome?

Responses to those questions, especially trends over time, should indicate whether your simplicity/efficiency efforts are succeeding. Even if you don’t prioritize and measure simplicity/efficiency, you can still be intentional and strategic when designing, building, and refining your compliance program.

In 2 minutes, we safely removed 46 bricks from our tower and added 20lbs. With another 5 minutes, we could easily remove another ~16 bricks and add another 20lbs. Just imagine the time, money, and effort you could save if your compliance program were ~40% simpler/more efficient but equally effective!#compliance #simplicity #compliancesolutions #healthcarecompliance