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The QA Pharm

Quality Insider

Got CAPA Backlogs?

Five underlying causes

Published: Tuesday, April 29, 2014 - 09:56

You would think that the corrective and preventive action (CAPA) system would be a business enabler—a disciplined approach to permanently resolving problems once and for all. Unfortunately, the way most CAPA systems are designed and used, it is more of a stumbling block. The system gets so chock full of stuff that backlogs are the norm, and a logarithmic increase in staff is required if you really want to keep current—or at least close as many CAPAs as you open for any given week.

You know the story: We have to get ready for the next inspection. The European Medicines Agency (EMA) said they were coming in, and we are also overdue for an FDA inspection. There is a clutching of the chest because we know we’re not in great shape. Our backlogs are back up again, and we can’t afford another observation about overdue CAPAs. And they are really on to us about liberally doling out extensions to the point that original target dates are meaningless to begin with. But we keep kicking the proverbial can down the road.

Regardless, we form Tiger Teams of our best and brightest to focus full time for the next several weeks to reduce the backlog—typically just viewing these as an exercise in paperwork. These stellar players let the work of their normal day job slip while well-intentioned management asks for daily updates that chip away at time normally intended for sleep. The only metric that matters at this point is the backlog so that, at the very least, we would be able to show a downward trend to the next inspector.

Thus the sawtooth cycle continues for years with the backlog steadily going up, followed by focused efforts to drive them down. And somehow we really feel good about our can-do attitude. It may not be fun, but we know how to pull together and deliver in times of crisis. Management rewards us once again for the fire fight.

Sound familiar?

A story like this only serves to show that the spirit and intent of the CAPA system has long been lost, and in reality, our CAPA system is out of control—and has been for a very long time.

The CAPA system is not making us any better and has actually become a "hidden factory” within our organizations that has found some self-serving purpose that has no relationship to making our products, processes, or systems any better. We need to step back, do a reality check, and admit that our CAPA system is broken and that we need to determine the underlying cause that led us to this situation so we can prevent its recurrence.

That sounds like a CAPA for the CAPA system.

Whatever we call it, we need to examine just about every aspect of the way we manage CAPAs, and be willing to let go of some deep-seated beliefs. One thing I have learned about the CAPA system during my 35 years is that beliefs about the CAPA system are held very deeply with doctrinal zeal.

So, let’s look at some fairly common CAPA practices that I believe are the underlying causes of the phenomenon I call “The CAPA Paradox.” In other words, with all these CAPAs, why aren’t we getting better?

1. The CAPA system is has become a quality work order system

The CAPA system, by definition, is intended to address problems and prevent them from recurring. However, CAPAs are opened for various reasons that range from delving deeper into a subject, to providing information about how frequently to change the deodorizer in the bathroom. In fact, a common practice is for every chartered project to also have a corresponding CAPA that contains the purpose, team member composition and roles, and major milestones.  There is no problem statement, no data, no root cause analysis, no action plan, no defined deliverables that correlate to the root cause—and no mention of how effectiveness will be determined. In other words, very little content having to do with the intent of a CAPA system.

2. Enterprise quality management software has become a project management tool.

Enterprise quality management software (EQMS) such as those developed by Sparta, EtQ, InfinityQS, and others are valuable enterprisewide computer applications that give visibility to their contents through their capability of tracking, notifying, and reporting. Unfortunately, rather than seeing these EQMS features as a tool to support the CAPA system, EQMS has become an end to itself. Anything that we want to give such visibility automatically goes into the EQMS. Thus, the capability of the tool has defined the CAPA system. The floodgate is opened to all who have access, which inflates the number of “CAPAs,” which causes the periodic panic.

3. CAPAs are opened without knowing the root cause.

When the unguarded portal of the CAPA system is open to the masses, we should expect to see a wide variation in practices and applications. Although quality assurance may be required to review and approve CAPAs, they are doing so against the long-eroded purpose—enabling bad practices. If there were just one high-leveraged change that would start the shift back to the fundamental purpose of the CAPA system, it would be to require a root cause (or most probable root cause) as the price of admission to the CAPA system. No root cause—no CAPA. A root cause provides the target for the purpose: Correct what? Prevent what? And the next change would be for quality assurance to be the gatekeeper to the CAPA system and to launch aggressive root cause analysis training and a strategy to reduce the number of employees that have access to the system.

4. CAPAs are not associated with things that matter.

Further, in addition to requiring a root cause, it must be an output of the deviation management system. By considering deviation management and CAPA as one continuous process, the CAPA system is properly directed toward product, process and quality system events that have some probability of product impact.  Not only is the number of CAPAs reduced, the remaining CAPAs matter—a better representation from a regulatory inspection perspective.

5. The low deviation threshold is debilitating.

Even though we associate deviation management and CAPA systems, when events that are many degrees removed from product impact are treated equally, it’s difficult to distinguish the significant issues from the noise. Providing alternative, risk-based pathways that permit rapid, real-time corrections and documentation is reasonable and compliant. Taking a “… for the want of a nail the shoe was lost, for the want of a shoe the horse was lost, for the want of a horse the soldier was lost…” to every event is neither noble or compliant.

Take this simple test to determine whether you need to examine how well your CAPA system is working.

1. Do you have a sawtooth backlog of CAPAs that result from heroic efforts?

2. Are your CAPAs only directed toward something that you can actually correct and prevent?

3. Do you have recurring, predictable deviations?

4. When you compare the total deviations per year for the last five years, is there a downward trend?

5. When you get a report from your EQMS, is it readily apparent that the most significant problems require immediate attention?

6. Does your company have intolerance for recurring deviations?

If your results are troubling, then it’s time to take a look at the design of your CAPA system, and perhaps, get back to the fundamentals.


About The Author

The QA Pharm’s picture

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).