Closing the Loop Part 4
Critical success factors for your compliance program
Mary Jo Climie, Principal Compliance
May 28, 2020

Until recently, managing the impact of a pandemic was the last thing on a life sciences company’s mind. In this new reality, monitoring business interactions is more relevant than ever. We hope this blog series can continue to highlight the value a compliance monitoring program can bring to your business.

In Part 3 of this 5-part blog series, I talked about the importance of learning the ‘why’ when something goes wrong and the differences, pros, and cons of reporting versus monitoring. In this blog, I would like to share with you some critical success factors of a compliance monitoring program.

Critical success factors in a compliance monitoring program

When setting up your monitoring program, here are things you might want to consider.

Know what you want to measure

Take a risk-based approach and be specific on what you are going to measure. Remember, this is not an audit. It’s meant to take the temperature of your program, not to diagnose the cause of the problem. Prioritize for “early indicators” or flags. It should be comprehensive enough to reveal insight to the business with actionable outcomes. A good first step is to build a relationship with your internal audit team to understand what they look for in conducting audits and mirror that in your monitoring program.

Establish a plan

Clearly state objectives and desired outcomes. Be clear on how it will impact the business. Determine an appropriate frequency for monitoring depending on the level of assessed risk. Don’t over-build the program at the beginning. You can use the data already available – transparency reporting, CRM, payment system – to build a foundation. Be mindful of the impact on the business and work to minimize disruption as much as possible. You should, for the most part, be able to conduct your monitoring without being intrusive to day-to-day operations.

Ensure leadership buy-in

When presenting your objectives to leadership, clearly indicate how the outcomes can help support business-decision making. Compliance programs are most effective and valuable when it’s a team effort from leadership on down. The tone from leadership is important. You will want to have your leadership on board when it comes to executing on corrective and preventative action plans and other remediation necessary to address any findings. People managers are essential allies and significantly increase the impact and perception of compliance. Work to ensure they are actively involved.

Corrective and preventative actions (CAPAs) & remediation
Have a well-defined and communicated methodology for your monitoring assessment. It’s important that the organization knows what you are doing, why you are doing it, and how it will help the business. While there is often an element of subjectivity to applying compliance guidance, try to report as objectively as possible, e.g. in aggregate or by business unit versus by individual. Also, be clear on the expectations for accountability on findings and how to address and remediate them. Reporting is only part of the story. To “close the loop,” be sure to document, track, and close CAPAs and other remediation.

Communicate, communicate, communicate

I recommend establishing two communication plans:

  1. The first plan should be for reporting findings
    • Work with leadership to determine the most appropriate way to report on outcomes. For example, do you highlight them individually or in aggregate? What reporting protocol would provide the most benefit while being the least disruptive?
    • However you chose to report, this is not a punitive exercise. It’s a way to identify opportunities to improve. Be sure how you report reflects that mindset.
  2. The second communication plan should be about the program itself
    • It should explain why monitoring will take place and how it can help individuals and the organization. You don’t want to surprise anyone.
    • Communicate intentions ahead of starting your monitoring program so everyone is aware and aligned.

You can also use the regular reporting as an opportunity for a compliance touch point to highlight key findings, guidance or tools to help with day-to-day activities. 

Monitoring programs

While monitoring, it will be useful to ask these questions:

  • Are activities happening in manners consistent with policies?
  • Should any activities be reduced or discontinued?
  • Are activities consistent with 'good business practices'?
  • Are all activities covered by appropriate policies and SOPs?
  • Are policies, SOPs comprehensive and clear?
  • Is training effective and/or appropriate?
  • Is there a culture of compliance?
  • Does management know what’s going on?
  • Do activities have a clear purpose?

A core element of a monitoring program is to have a continuous improvement mindset. The root cause of observations can come from almost anywhere, so apply a critical lens to what you are seeing and ask curious questions.

While these questions help to validate activity for the business, they also highlight where to focus compliance resources and energy to provide the best support. 

In Part 5 of this 5-part blog series, I will talk about other complimentary initiatives and how monitoring helps a compliance program to evolve and grow with the ever-increasing complexities of a business in the life sciences industry.

Can’t wait? You can listen to the entire “Closing the Loop” webinar now available on-demand.

You may also be interested in