A Tale of Two Deviations

It stands to reason that pharmaceutical companies in compliance trouble also have problems with their Deviation Management and Corrective and Preventive Action (CAPA) System(s). After all, to maintain a good compliance profile, as well as an efficient operation, requires the ability to detect problems, determine the root cause and permanently eliminate the problems.

Good companies rejoice that a problem was detected and reward the one who detected it. It's another opportunity to improve---one more problem that they never have to deal with again. They rise to the challenge to find technical solutions and engineer-out the problem. They are thinkers who mindfully apply their education and experience. They celebrate finding and permanently expunging recurring problems. Management is aware of and measures recurring problems. They have no tolerance for it and hold department managers accountable for measurable results.

For poor companies, deviations are a way of life. Deviations are anticipated and the rewards go to those who heroically work the long hours to jump through the usual hoops to close the deviations so the lot can get out the door. They know that they will have to go through the same effort the next time. It is an exercise in onerous paperwork and checking procedural boxes. They celebrate getting the lot out the door---finally. Management measures delayed investigations and backlogs. Everyone knows what the routine problems are, and management asks no more than they be handled in the routine way---just more quickly.

Like in A Tale of Two Cities, they are worlds apart in organization culture. One cannot change culture by policies or procedures. It's a force that emanates from the top. It's a force that cannot help but to become infused into every breathing soul. Culture invigorates and identifies who we are in our very essence.

It's leadership. And leaders that build a positive culture would ask, "Why would we not permanently irradiate problems at their festering roots---even if it's one of us?"


The QA Pharm