During the 2022 PDA Data Integrity Workshop held on September 15th and 16th, in Washington, D.C., the topic of “rewards for meeting Quality Metrics” was mentioned several times. You may have been the recipient of a work-related incentive at one time or another during your career for meeting a Quality Metric or for achieving some other company goal. The reward could be as inconsequential as getting an additional day off, dinner for two, or tickets to a sporting event, or it could be more substantial in the form of bonuses and/or stock options.
It is nice to be rewarded for your hard work, but what is the cost to your company’s product quality and compliance for this arrangement? When the company offers an additional incentive to meet a critical due date, such as a regulatory filing, are you working compliantly and at the best of your abilities to produce a high-quality work product, or are you rushing to meet a timeline and delivering a sub-par work product? If an incentive is offered to meet a Quality Metric, such as reducing the number of laboratory and manufacturing investigations, what actions do you take to meet that Quality Metric goal? Are all incidents reported and investigated, or if the incident is not significant, is it reported? If the incentive or reward is significant, it is possible that there may be people within your organization who will take short-cuts to achieve the goal and receive the reward. You may say that “it could not happen at my company. All our staff has integrity.” However, it does happen, as many examples of data integrity incidents can be found in FDA 483 and Warning Letter observations, as FDA has ramped up the scope of where they are looking for these incidents in the last few years.
The company’s apparent nice gesture to provide an incentive/reward for meeting a Quality Metric or other goal is not the best approach, as compliance and product quality may be impacted. Before offering any incentives/rewards, the risk of any indiscretions to meet your company’s Quality Metric or goal, should be evaluated.
If you have any questions about establishing a compliant metrics program at your organization, please reach out to us at LCS@LachmanConsultants.com