Action Items

After being notified about action items, the vendor will see them listed under "Action Items." The vendor can view the details of each item by clicking the corresponding list entry.

Clicking the list entry will open the action item form where the vendor can review and edit the details about the action item.

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. You can view the document, view its properties, download it, or delete it by clicking the respective icons.

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 vendor can edit or delete the CAPA plan if changes are needed. When all details are finalized, the vendor can submit the CAPA plan to the action owner.

Upon submitting the CAPA Plan, an acknowledgment message will appear. The vendor can then either download the submitted plan or return to the action item screen by clicking the back button.