Q: At my company, a non-conformance report (NCR) is initiated for a product non-conformance that is created and found internally.
Would you automatically elevate the NCR to a corrective action request? In other words, with the exception of issues you decide to just monitor and trend — such as perhaps a safety issue — should every non-conformance report become a CAPA?
A: Whether a CAPA is needed should be based on your understanding of the product and manufacturing process. Is the non-conformance occurring within an acceptable frequency and severity? Is it occurring in an expected manner? If not, elevate it to a CAPA and do a full-blown root cause analysis, then take a corrective action.
In addition, evaluate the extent of the issue so you can identify opportunities for a preventive action for other products or processes. You should also apply this approach to complaints, because a complaint is simply an externally found non-conformance.
[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]A complaint is simply an externally found non-conformance.[/pullquote]
If you rely only on a safety analysis, you won’t be compliant with FDA’s expectations. FDA regulates both safety and effectiveness. A fail-safe mode does not excuse you when the event or failure mode is occurring too frequently. This is also true of foreseeable product misuse and abuse.
Be careful when doing your calculations for frequency. If the event can or will occur in the lifetime of the device, making your denominator large will not be viewed favorably.
By the way, fixing the non-conformance is a correction, not a corrective action. Fixing the immediate issue by making a change to a component would be more of a correction. The time to open a CAPA is when you need to make a substantive change to improve a process, product or the quality system. Incremental fixes are rarely systemic and often lead to future problems.
Answered by Denise Dion, Vice President of Regulatory & Quality Services at EduQuest (18 years as an expert FDA investigator and as the co-editor of FDA’s Investigation Operations Manual). Denise also is the lead instructor and developer of EduQuest’s CAPA Clinic: FDA Rules for Effective CAPA Systems, Failure Investigations and Complaint Management.