We ensure that we conduct an investigation and are able to complete the risk analysis portion of the CAPA within 30 days but we do not require completion and closure of the CAPA within 30 days. That is usually not possible. However, we have quarterly meetings of our CAPA team where the responsible individual reports progress on the open CAPAs to the CAPA team, and the CAPA team assesses the progress. The minutes from these meetings are documented as part of the CAPA process. We have the responsible individuals provide a time frame for closure but the CAPA team will approve an extension of that time frame based on circumstances. However, we have meeting notes showing that we are actively working on the CAPAs and that we are monitoring their progress. There are core members of the CAPA team and other individuals are added to the team as needed to address the current CAPAs. We have CAPAs that have been open over a year but we have documentation of the status and the progress throughout the period that the CAPA is open. We have also had multiple time extensions on CAPAs but always document the reason and document that the CAPA team approved the time extension. This approach has passed FDA and Notified Body inspections.
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Dixie Sells
VP RA
Sandy UT
United States
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