Tell Me About ... Problems

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Leaders always like to hear good news - no issues, everything on track, systems running well. Its never fun getting an email or call at 6pm on Friday regarding a problem. A not too infrequent occurrence for anyone in Pharmacovigilance - batch of un-submitted safety reports, a potential new safety signal, sudden large drop in your compliance metrics. Occasionally, these are out of the blue events - both unanticipated and unavoidable. However, sometimes these have been simmering for a few days or even weeks, and you are only hearing about them as you try to walk out the door.

Rather than see these as unconnected events, it may be worthwhile assessing your team's culture in addition to doing the standard root cause analysis and CAPA process. Sometimes it is about more than just SOP execution. If you, as a leader, do not create, cultivate and maintain a culture where everyone is encouraged and rewarded for raising issues early, then this will continue to happen. Getting to the reason for delays in information flow or issue escalation will pay huge dividends.

Getting down to the level of individual motivation is never easy, but it is possible to identify themes affecting the team or even the company as a whole. In one instance, the reluctance to escalate issues had to do with the perceived loss of reputation for the individual and their supervisor. A fear of negative performance evaluations meant that the issue was left unaddressed for several months. They knew the SOP and the need to inform line management, but this mindset actively worked against the timely sharing of information. Once they realized that problems only get bigger with time, given strict regulatory timelines, and that unresolved issues could affect overall company performance and reputation, issue escalations were earlier and faster than before. The use of awards and public recognition helped establish a more open communication culture with each other and their managers.

My advice to new leaders is to worry if you are not hearing about any issues or problems and if you are finding delays in the time to escalation for when you do.