Q: Can a company maintain just a CAPA Log — and not even keep a Complaint Log — and still be compliant? Do most companies keep both?
A: The answer to your first question is yes, technically. In theory, any complaint, non-conformance, etc. could be given a name — let’s say, “CAPA” — and your procedures then would have to distinguish a CAPA that’s a complaint from those that aren’t. Furthermore, your procedures would have to describe how — and if — they are handled differently.
In reality, though, I think this approach could be tricky because the term CAPA of course means Corrective and Preventive Action. That implies the result of opening — or logging — something you call a CAPA will result in a corrective or preventive action.
Not all complaints or other non-conformances may require a corrective or preventive action.
But not all complaints or other non-conformances may require a corrective or preventive action. You’ll also need to determine if any CAPAs that are actually complaints represent a Medical Device Reporting (MDR) event.
In answer to your second question: yes, most companies do keep both. Most have separate Complaint Records and Procedures, separate CAPA Records and Procedures, and even separate Non-Conformance Records and Procedures.
Because of the possible semantic as well as practical problems you may encounter in keeping an all-encompassing CAPA Log, I’d suggest you proceed cautiously.
Answered by Denise Dion, EduQuest Vice President of Regulatory and Quality Services (18 years as an expert FDA investigator and trainer) and Course Leader of EduQuest’s The CAPA Clinic: FDA Rules for Effective CAPA Systems, Failure Investigations, and Complaint Management training class.