The PA Part of CAPA

Preventive action is a proactive process to identify improvements rather than a simple reaction (corrective action) to identified potential or known problems. Apart from the review of operational procedures, the preventive action might involve analysis of data, including trend and risk analyses and proficiency-testing results.  The focus for preventive actions is to avoid creating deviations (non-conformances), but also commonly includes improvements in efficiency.  Many organizations require that when opportunities to improve are identified or if a preventive action is required, action plans are developed, implemented and monitored to reduce the likelihood of deviations (non-conformances) and to take advantage of those improvement opportunities. Action plans are the collective organization of: activities to perform, deliverables to provide and dates to complete by.  These action plans would be the manner in which preventive action(s) should be implemented.  Additionally, a preventive action process will include an effectiveness check to ensure that your efforts are effective in eliminating or reducing occurrence.  Effectiveness checks will logically occur after a period of time from when the action plan has been completed.

Speaking from personal experience the preventive action part of a CAPA is, for the majority of the time, is derived from deviations (non-conformances), i.e. known issues. The Quality Unit’s that I’ve been apart of are mostly in a ‘fire fighting’ mode; trying to resolve issues, determine product impact, correcting the issue (i.e. bringing the product, area, system, etc back into a state of quality / compliance), and preventing the issue (i.e. implementing change to prevent the known problem from re-occurring). So, with that said, it is a rare occurrence to avoid potential deviations (non-conformances).  There is difficulty in developing preventive actions for an issue that hasn’t occurred yet, additionally how do you measure and determine, through an effectiveness check, that the lack of deviation occurrence is a result of your CAPA or that your system/process was sufficient to begin with?

If we continue with the mindset that CAPAs are mostly derived from known issues, and if I were to give a general statement around preventive actions compared to corrective actions, I would have to say that preventive action needs to take a different approach then corrective action.  Corrective actions are trying to bring your process, system, product, etc back into a state of quality/compliance (i.e. immediate fixes, the here and now).  Preventive actions are to implement changes or add / delete processes, steps, reviews, training, etc to prevent the issue from occurring in the future, not only where it has already occurred, but all other areas with similar conditions.