CAPA Categories are used to manage the assignment, escalation, and expected resolution time for Corrective Actions. Each Category has a default rule, and sub-rules can be created to allow assignment, escalation etc. based on Facility/Location.
Categories can be managed from the Actions app, or from the Inspections portal.
To add a CAPA Category, start by logging into the web app and selecting the Actions tile:
- Click the drop-down menu.
- Click Categories.
- Click New.
Next, enter the Category settings:
- Enter a Category Name.
- Select the Owner of this CAPA. The Owner can reassign the CAPA if needed, and add Notes on how to resolve the CAPA. This list will only contain Users.
- Select the person this CAPA would be assigned to. The Assigned To can only view CAPA notes, change the status/resolve the CAPA, and upload attachments. This list will contain Users and CAPA Recipients.
- Optional: Select users to be notified, or copied, on Corrective Action assignment emails.
- Enter the Days To Resolve. (the default number of days a person has to resolve Corrective Actions in this category).
Next, Complete the Escalation tab:
- Click Escalation.
- Select a First Escalation To. If this CAPA is still unresolved, it remains assigned to the original person, but the First Escalation user is notified. (Please note: Multiple First Escalation users can be selected.)
- Select a Second Escalation To. If this CAPA is still unresolved, it remains assigned to the original person, but the Second Escalation user is notified. (Please note: Multiple Second Escalation users can be selected.)
- Enter the First Escalation Days (the number of days from the Due Date to perform the First Escalation. e.g. -1 would be 1 day before due date).
- Enter the Second Escalation Days (the number of days from the Due Date to perform the Second Escalation. e.g. 0 would be on the due date).
- Click Update.
If there should be different CAPA settings for each Facility, or for a different Inspection Category, create the overall category, then click on it. Now, you can create a Custom Assignment Rule.
Now, enter the details:
- Select the Owner of this CAPA. The Owner can reassign the CAPA if needed, and add Notes on how to resolve the CAPA. This list will only contain Users.
- Select the person this CAPA would be assigned to. The Assigned To can only view CAPA notes, change the status/resolve the CAPA, and upload attachments. This list will contain Users and CAPA Recipients.
- Optional: Select users to be notified, or copied, on Corrective Action assignment emails.
Next, Complete the Escalation tab:
- Select a First Escalation To. If this CAPA is still unresolved, it remains assigned to the original person, but the First Escalation user is notified. (Please note: Multiple First Escalation users can be selected.)
- Select a Second Escalation To. If this CAPA is still unresolved, it remains assigned to the original person, but the Second Escalation user is notified. (Please note: Multiple Second Escalation users can be selected.)
- Enter the First Escalation Days (the number of days from the Due Date to perform the First Escalation. e.g. -1 would be 1 day before due date).
- Enter the Second Escalation Days (the number of days from the Due Date to perform the Second Escalation. e.g. 0 would be on the due date).
Next, complete the Filters tab:
- Optional: Select the Facility this custom assignment rule applies to. You can filter further by Level 1, Level 2, and Location if these rules should be very specific.
- Optional: Select the Inspection Category this custom assignment rule applies to.
- Click Update.
To edit a CAPA Category, highlight its name, and click edit.
To remove a CAPA Category, highlight its name, and click Delete. Please note: A CAPA Category cannot be removed if it is in use.