The Tale of Two Deviations

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.

By THE QA PHARM

QA PharmIt 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, 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 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.

It's a tale of two deviations. They are different worlds, differing in how problems are managed and organizations are led.

Keep shining the light in the right direction and make a difference.

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