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?"


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The Top Ten Reasons the Deviation Investigation System Fails

For some companies, manufacturing is a crapshoot. There is little basis for confidence that that the right equipment, materials, components, people and records will be at the right place and the right time to begin manufacturing. And once manufacturing has begun, a crystal ball is as good as anything to divine whether the product batch will be released on schedule.

Manufacturing is a continuing exercise of muscling and cajoling the product from one stage to another while the zealous QA department chalks up one deviation after another that sends the minions scattering about to do the minimal essential work required to release the product to market.

Deviations and the associated CAPAs begin to amass and backlogs soon become the ominous specter that one would just as soon explain away just as Scrooge did his night visitors.

This scenario is nothing less than a testament to an out-of-control situation, and deviation investigations are nothing more than slight-of-hand or putting the best face on recurring, nagging and relentless problems.

There is always time to crank out the perfunctory deviation investigations, but never enough time for leaders to emerge to mindfully gain control of the situation through conscious understanding of the underlying causes for the mayhem and carve a path forward out of the wilderness. Rather, management decries the onerous GMPs that burden the business while patients are desperately waiting for your magnanimous supply of lifesaving drug.

Warning Letters are fraught with observations that point to issues with the deviation investigation system and the ability to solve problems once and for all. Here are my top ten reasons that the deviation/investigation/CAPA system fails:

1.   R&D throws half-baked processes over the fence to operations, saying that they did their part to file a submission to the FDA ahead of the competition. Now it’s time for Operations to take over in the spirit of continuous improvement.

2.   The event occurs and is opened in the system, but there are delays in gathering time-sensitive information. It is not until the time gets close to release the product that open deviations surface and stand in the way. Unfortunately, no one has accurate information to assemble the facts for a meaningful investigation.

3.   Products impacted by the deviation are not evaluated based on scientific data, and the perimeter is not drawn wide enough to include anything beyond the current batch—and certainly not to anything released into the market place.

4.   The true root cause or most probable cause is not determined by a disciplined approach, and is not documented. The root cause reads more like a problem statement, or the symptoms of the problem. The bottom of the problem is not reached, and will surely stop short if the true cause touches on a politically sensitive subject.

5.   Significant deviations cannot be distinguished from all the minor issues flooding into the system. When every single documentation error is entered into the system with its corresponding investigation and CAPA, it’s no wonder that there is a backlog and meaningless activities working at cross-purposes.

6.   Deviations are seen as singular events, rather than yet another example of a problem that is already identified as a deviation in the system. There is no “look back” to determine if the new event is already covered by a current effort, or the evidence of an ineffective CAPA.

7.   Inappropriate ownership for deviations leaves QA with a conflict of interest. The areas responsible for causing the deviation have no incentive to permanently resolve the problem, because they know that QA knows the “right way” to write it up to get the lot released. QA “rationalizes” rather than independently assesses the “justification.” (See The QA Pharm 10/30/10.)

8.   Performance metrics are not presented to management for review in an action, decision-oriented forum where assignments are made, followed-up at subsequent reviews, and individuals by-name held accountable for results.

9.   Because TrackWise (an excellent system) provides visibility to problems and serves as a tracking tool, junk gets into the system for those two reasons only (visibility/tracking) when in actuality they are neither a deviation, nor a CAPA. Events going into data management system must meet the definition of a deviation, and there cannot be a CAPA without first having a root cause.

10. There is a tolerance for repeated problems.

How do you score against these top ten reasons?

The QA Pharm