CAPA is Good for Business
There is considerable debate about the CAPA system. On one hand, if systemic nonconformities are realized (exist) then it makes good business sense to get to the bottom of the problem (the “root causes”), fix them, and take actions to ensure they never happen again. On the other hand, the “Preventive Action” aspect is, frankly, difficult! Companies do “Preventive Actions” all the time (e.g., reviews, prototypes, etc.) but rarely run these actions through the “Preventive Action” process.
Do FDA Inspections Make Products Safer or More Effective?
FDA inspection findings in CAPA have been consistently at the top of the list. But is this making products safer or more effective? With all the recalls and litigation, it hardly seems so!
Self-Inflicted Wounds
A very non-scientific look at the types of findings, though, start to paint a picture of many of the findings being self-inflicted through a CAPA process that is not well-understood and thus implemented incorrectly. One of the worst offenses is stating (in the CAPA Standard Operating Procedure or SOP) that all CAPAs will be closed within some time period, say, 60 days. Again, this shows a lack of understanding of the CAPA process and implements a process that cannot be followed. Inspectors, in such cases, have no choice but to issue findings!