When a NC is escalated to a CAPA,a CAPA record is automatically created once the NC is approved.
Note: This video was created using V1.24.2. Enzyme is updated weekly so some elements may change.
CAPA's can be edited by users with permission level of Quality Owner, Approver and Editor. The CAPA module can be accessed under the Improvement Tab.
To view a CAPA, hover over and click on the row.
Phase 1 Investigation Planning
The purpose of Phase 1 is to appropriately scope the CAPA, particularly for Phase 2 which is typically the the most active phase. In Phase 1, it is important to consider the time necessary to complete the investigation, determine appropriate solutions, to document an evaluation of those solutions, and to plan the implementation steps that will occur in the following phases. A properly scoped and planned CAPA will better ensure its timeliness and its effectiveness.
In Phase 1, the initiated date reflects the date that the NC’s escalation to CAPA was approved. The Phase 1 due date reflects the due date that was set in the NC as part of the escalation. You can also view any attachments that were added to this phase.
In the Investigation Plan Elements section you will see default milestones. Edit, delete, use, or add to these elements as desired. Drive accountability for completing these actions by assigning tasks to users with target dates.
Once the plan for the schedule/milestones of Phase 2 Investigation Results is complete, input a due date or Phase 2 commensurate with the planned activities and select the Approvers for Phase 1.
The approvers and role(s) that populate are based on the CAPA approval settings managed by the Quality Owner in the Approval Settings within their Settings menu.
The CAPA Owner must approve the Phase as an Individual Approver, and at least one other person must approve it as well. It’s required to add at least one approver from each Role in bold, and it’s required to add each Individual Approver in bold. These approval settings are established by the Quality Owner in the administrative approval settings “Other” tab.
Once approvers are selected, click on Save and Submit. Those approvers will be notified of the CAPA Phase approval request. It will be routed for approval based on the approvers you specified. Once it’s approved you will see a green line under the Phase at the top of the tab.
Phase 2 Investigation Results
Phase 2 is the investigation to determine the actual or most probable root cause(s) and the proposed solutions (that have been validated and verified).
In the Investigation Plan Elements, the CAPA owner can enter the root cause and proposed solution(s). Enter the completion date and the results. In the results you can also include attachments. You must indicate if there were any deviations from the investigation plan and provide appropriate justification(s).
In the Root Cause Analysis, describe the root cause and attach any corresponding documentation. You can select root cause codes which were added by the Quality Owner within the NC/CAPA settings. In this section also indicate the proposed solution(s) and additional detail for the verification and/or validation performed on the proposed solution(s).
Next, Implementation Plan Elements must be added; they span all required actions associated with the proposed solution(s) above. Add a row for each associated action, and people can be assigned to support them along with target dates for completion.
Finally, the Verification of Effectiveness (VOE) Criteria must be entered; this will be the criteria against which the CAPA will be evaluated for effectiveness in Phase 4.
Select the Phase 3 Due Date and approvers. When you are ready, you can submit Phase 2 for approval.
Phase 3 Implementation
Phase 3 contains the evidence of implemented solution actions. Any deviations should be described and justified. The Phase 4 due date is selected, and you submit it for approval.
Phase 4 Verification of Effectiveness (VOE)
The purpose of Phase 4 is to evaluate the effectiveness of the solution(s). Provide information about any deviations, and the effectiveness of the results.
Once you are done, select the approvers and submit Phase 4 for approval.
Summary and Closure
Once Phase 4 is approved, you will see the Summary and Closure tab. This is the executive summary of the CAPA and a list of the approvers. Once you have entered the executive summary, you will have to route it for approval. Once the summary is approved, the CAPA is closed.
Edit Approved CAPA Phase
To edit an approved CAPA phase, from the CAPA module, hover and click over the CAPA in which you are interested and select the phase.
Click on the Edit icon and make the edits you need. When you are done, click on Save Changes and you’ll return to the CAPA module. Re-open the CAPA and the phase you edited; all subsequent phases will now be in draft state as well.
When you are ready, re-submit the CAPA Phase and all the subsequent phase(s) that were previously approved will also have to be re-submitted for approval.
If you have any questions, you can reach us through the in-app chat or email us at firstname.lastname@example.org.