CAPA Plans and Audit Closure

CAPA plans are required to be completed by the auditee to address audit observations. The CAPA plan is intended for the auditee to outline the root cause analysis, corrective actions, and preventative actions for each observation. Anticipated completion dates and the contact for ownership of the CAPA is also to be documented on the CAPA plan. The CAPA plan template is usually provided by the audit sponsor to the auditee with a date for submission of the CAPA plan for review. The CAPA plan is separate from the tracking of individual CAPAs and provides an overview of the intended activities for completion by the auditee. The sponsor may request the auditor participate in the review of the CAPA plan to ensure the auditee is adequately addressing the issues that lead to the assignment of the observation by the auditor. The auditor has cumulative knowledge based on documents reviewed, interview sessions, evidence provided and knowledge of the associated regulations. For some sponsors, review of the CAPA plan by the auditor ensures the auditee is adequately addressing the deficiency that resulted in the observation.