When a nonconformance occurs, it can be escalated to a Corrective and Preventive Action (CAPA). A CAPA is the set of actions a company will take to systematically mitigate the causes of severe or frequently recurring NCs.
In Enzyme's CAPA module, a CAPA record has four (4) Phases:
Investigation Planning: Scope out the CAPA
Investigation Results: Investigation to determine the actual or most probable root cause(s) and the proposed solutions (that have been validated and verified)
Implementation: Contains the evidence of implemented solution actions. Any deviations should be described and justified
Verification of Effectiveness: Evaluate the effectiveness of the solution(s)
Be sure to provide information about any deviations, and the effectiveness of the results. Once Phase 4 is approved, you will see the Summary and Closure tab which is the executive summary of the CAPA. Once the summary is routed for approval, the CAPA is closed.
A CAPA may be created in two ways.
NC is escalated to a CAPA (and approved).
Created directly in the CAPA module (requires activation of a NC/CAPA Setting).
You can add additional information to the CAPA Phases. When the information is complete, route it for approval. Once a CAPA phase is approved, it can still be edited to add more information.
Creating & Editing a CAPA
When the information for a CAPA is complete, you can route it for approval. Once a CAPA phase is approved, it can still be edited to add more information.
Extending CAPA Phase Due Date
If you need more time to conduct your investigation, the CAPA phase due date can be extended. Users with the permission level of Quality Owner, Approver, and Editor can request CAPA extensions.
Canceling a CAPA
If a CAPA is no longer needed, it can be cancelled at any time. In order to cancel a CAPA, it must be routed for approval.