A Tale of Two Deviations

From two companies worlds apart in organizational culture

Published: Thursday, May 3, 2012 - 12:13

It stands to reason that pharmaceutical companies in compliance trouble also have problems with their deviation management and corrective and preventive action (CAPA) systems. After all, maintaining 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 the company never has to deal with again. It rises to the challenge to find technical solutions and engineer-out the problem. The company supports its thinkers who mindfully apply their education and experience. It celebrates 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 not-so-good 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 they will have to go through the same effort the next time. It’s 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.

As in Charles Dickens’ A Tale of Two Cities, the two companies are worlds apart in organizational culture. One can’t change culture by policies or procedures; it’s a force that emanates from the top. It’s a force that can’t help but become infused into every breathing soul. Culture invigorates and identifies who we are in our very essence.

It’s leadership. And leaders who work to build a positive culture would ask, “Why wouldn’t we permanently irradicate problems at their festering roots—even if it’s one of us?”

About The Author

The QA Pharm

The QA Pharm is a service of John Snyder & Co. Inc., provider of consulting services to FDA-regulated companies to build quality management systems and develop corrective actions that address regulatory compliance observations and communication strategies to protect against enforcement action. John E. Snyder worked at the lab bench, on the management board, and as an observer of the pharmaceutical industry for more than 30 years. His posts on The QA Pharm blog are straight talk about the challenges faced by company management and internal quality professionals. Synder is the author of Murder for Diversion (Jacob Blake Pharma Mystery Series Book 1).