CAPA madness!

CAPA madness!:

Many pharmaceutical firms have a system for dealing with CAPAs (Corrective Actions and Preventive Actions).  This is an important system as it deals with problems that occur and should also be used to prevent future problems occurring too.  Readers should also see a related post from January on how the industry has made a lot of mistakes on how it defines and uses CAPAs, and how this can lead to ineffective CAPA systems.  Another problem of CAPA systems that I have seen comes from assigning a set date (usually 30 days) to close them all.  This can cause more problems than it solves!

The setting of a date to close a CAPA is a good idea.  It provides a target to work towards.  However, setting a blanket “one-size-fits-all” date to close all CAPAs often causes further problems.  This is what can happen if a set target of, say, 30 days is applied to close all CAPAs.

It might need to be done quicker

It may be that a CAPA is so significant that it may need to be dealt with immediately and not left to wait for a month!

It might be simple to do

It may be that it can be dealt with and closed immediately if done now – so why wait?

It might take longer than 30 days

This is my main concern – in order to effectively close a CAPA it might take time to establish the root-cause and get the corrective action done right.  It might also take time beyond 30 days to establish sufficient evidence that the problem has been sorted for good.

We are all human

The final problem of establishing a set target (say 30 days), is that it can encourage little activity until Days 28, 29 & 30 and also can lead to quick-fixes on the final due date too!

Don’t get me wrong.  I am not saying that there is no point establishing a due date to deal with CAPAs, nothing can be further from this.  However, I firmly believe that each CAPA should be dealt with on a case-by-case basis, with timeframes, actions and responsibilities established with the key-players involved at the time.  Timeframes for actions should be based on the risks involved.  Please let me know what you think.