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Purpose

Getting overwhelmed in managing and tracking all the deviations, quality events or CAPAs? Who to assign them? What are their current status'? How many are overdue? Is a CAPA needed? This application addresses all of those concerns. It is important to have a consistent workflow for managing Quality and CAPA events so that the root cause can be determined, corrective action can be taken, and changes can be implemented to prevent events from happening again. Use this application to manage open events, but also to keep a historical record of past events and evaluate how your team is managing and responding to quality events.

Overview

This applications works closely with the *Events table. Every time a new Quality Event or CAPA event is submitted, it is entered into the *Events table. The 'Type' column is populated to denote if it is a Quality Event of a CAPA. The following metadata stored with each event at the conclusion of the entire workflow includes:

-Description

-Location

-Created By

-Created Date

-Actions Taken

-Investigation Summary

-Owner

-Due Date

-Linked Records (if applicable)

The application has a pre-defined workflow that guides an event through pre-configured screens in order to move the event through the following states:

-SUBMITTED

-IN REVIEW

-UNDER INVESTIGATION

-CLOSED

To view more about the workflow, see the charts below:

Deviation Manager Workflow

CAPA Manager Workflow

Installation Instructions

At each state change there is also a new Owner assigned to the ticket. In order to configure and make this application your own you must update the logic to have it route to the appropriate Owner for your organization. In the App Editor make the following updates:

  1. On 'Report Quality Event' Step click on 'LOG EVENT' button.

  2. Click the pencil icon next to the 'Log Event' trigger

  3. Update the last action to assign to the Quality Manager in your organization.

  4. Open the 'Report CAPA Event' step and click on 'LOG CAPA' button

  5. Repeat steps 2 & 3

  6. On 'Update Quality Event' step click on the 'SUBMIT' button

  7. Click the pencil icon next to the 'Update Event' trigger

  8. Update the last action to assign to the Quality Manager in your organization.

  9. On 'Update CAPA Event' step click on the 'SUBMIT' button

  10. Repeat steps 8 & 9

Optional Modifications

If the status' we provided don't work for your organization, you can easily change them by modifying the triggers at each state change. Use this chart to locate the different state changes:

State Change

Step Name

Button Name

SUBMITTED

Report Quality Event

LOG EVENT

SUBMITTED

Report CAPA Event

LOG CAPA

UNDER INVESTIGATION

Assign Status

UPDATE STATUS

CANCEL

Assign Status

UPDATE STATUS

IN REVIEW

Update Quality Event

SUBMIT (Update Event)

IN REVIEW

Update CAPA Event

SUBMIT(Update Event)

CLOSED

Additional Info - Accept

UPDATE

UNDER INVESTIGATION

Additional Info - Reject

UPDATE

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