Corrective and Preventive Actions (CAPA)
Human subject research conducted at the University is routinely audited and monitored by internal and external entities. As part of these visits, non-compliance with federal, state, and local regulations or institutional policies may be identified. Depending on the severity of these issues, it may be required that a CAPA Plan be created and implemented. The RQA CAPA Manager assists University researchers and their team with the creation and implementation of CAPA Plans.
What is the purpose of a CAPA Plan?
A plan that is developed and implemented to identify, remediate, and prevent recurrence or occurrence of existing or potential causes of non-compliance or other quality issues.
What is Root Cause Analysis?
Root Cause Analysis (RCA) is a structured process for identifying “root causes” of problems or non-compliance.
What is a Corrective Action?
An action taken to eliminate identified non-compliance and /or an action taken to address and correct a problem. The non-compliance may be identified by either external or internal sources.
What is a Preventive Action?
An action taken to eliminate the root cause of a problem and to prevent the issue from reoccurring in the future. Also, an action taken to prevent non-compliance from occurring.
