Action Items

Once notified about action items, the action owner can find them listed in the 'Action Owner Work List' tab under 'Action Items' sidebar . To view the details of each item, the owner can click on the corresponding list entry.

Clicking the list entry will open the CAPA Form where the action owner can review the action item summary by clicking it.

Click the "Edit" icon to modify details like immediate correction details, Traceability information, etc. Enter the necessary data (e.g., date) in the relevant fields. Click the "save" icon again to save your changes.

Click the "Add RCA" to initiate the RCA process.

A pop-up window will appear with fields for: Root Cause (dropdown menu), Impact (dropdown menu), Root Cause Description (text field).

Fill in all relevant information and the root cause description. Click "Click to Upload" to attach a document (optional).

Click “Add” to proceed further and add the RCA. Click "Cancel" to close the pop-up window without saving.

If CAPA Required is selected as “Yes”, a "+ Add CAPA" icon will be displayed next to the Root Cause Analysis (RCA) item list. If CAPA Required is selected as “No”, the icon will be absent.

Click the "+ Add CAPA" icon, appears next to the RCA item list. Complete the CAPA Details in the Pop-Up Window: Select the appropriate category from the dropdown menu. Provide a clear and concise description of the corrective action in the text field. Enter the anticipated date for implementing the action in the “Estimated Implementation Date” Enter the expected date for completing the action in the “Estimated Closure Date”.

Click "Add" to save the CAPA details and add the plan to the action item. Click "Cancel" to close the pop-up window without saving the CAPA.

Once a CAPA plan is added, it will be listed in the "CAPA Plan" list. The Action owner can edit or delete the CAPA plan if changes are needed. When all details are finalized, the action owner can submit the CAPA plan to the verifier for review.