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!

CAPA – time for a rethink?

CAPA

Most manufacturing sites these days have CAPA systems – a mechanism to capture, record, control and approve or reject Corrective Actions.  Despite the fact that a lot of focus has been given to CAPA in recent years, there is a great deal of misunderstanding and a clear lack of clarity on what CAPA actually is.  This may explain why many organisations feel that they are still in “fire-fighting” mode – always dealing with yesterday’s problems rather than preventing future issues from occurring.