Working with Issue Escalation (QMS)

Many regulatory authorities require that organizations have a process by which serious issues that arise out of complaints, deviations, inspections, or compliance issues are formally escalated to management.

Using the Issue Escalation object, organizations have a method of recording issues that surface through Quality Events and relating those issues back to the originating event. You can then escalate such issues to management for awareness and triage towards closure. All notifications sent to management via Issue Escalation records have traceability in Vault audit trails, providing a receipt of who was contacted as an Issue Escalation Notification record.

Creating an Issue Escalation

To create an issue escalation:

  1. Navigate to an Issue Escalation custom tab or to Business Admin > Issue Escalation.
  2. Click Create.
  3. Fill in the required details.
  4. Select a Source. This field value indicates the originating issue category.
  5. Optional: Fill in the remaining details as required by your organization’s process.
  6. Click Save.

External Source Escalations

Your organization may have issues appropriate for the Issue Escalation process and tracking but those events are not captured in QMS. For these issues, you can populate the Related External Event field to capture the ID that represents the event in your external system.

Reviewing Issue Escalations

Issue Escalation configurations typically include a review workflow to ensure that all data on the Issue Escalation record is complete and accurate. Once an Issue Escalation record contains all the necessary information, it is ready to be escalated and for Vault to send a notification to managing users.

Issue Escalation Notifications

When an Issue Escalation record reaches its completed state, for example, Closed, Vault can send a notification to the appropriate Users using the Send Issue Escalation action. Vault creates an Issue Escalation Notification record to track this notification and its relevant metadata, such as Sent Date, the related Issue Escalation, and Recipients.

If Vault sends the notification as the result of a workflow step, the Issue Escalation Notification record lists System as the Sender. If, instead, you send the notification with a user action, your user account will be listed in the Sender field. Once sent, this notification is recorded in the Issue Escalation record audit trail, including the record Name and Purpose.

Follow-Up Quality Event

After an Issue Escalation is closed, you can create an associated follow-up Quality Event, linking the Issue Escalation and the subsequent action taken for a complete traceability record.

The following permissions control your ability to use Issue Escalations:

Type

Permission Label

Controls

Security Profile

Object: Issue Escalation

Ability to view, create, edit, and delete Issue Escalations.

Security Profile

Object: Issue Escalation Notification

Ability to view Issue Escalation Notifications.

Security Profile

Object: Issue Escalation Impacted Country

Ability to view, create, edit, and delete Issue Escalation Impacted Countries.

Security Profile

Object: Issue Escalation Impacted Organization

Ability to view, create, edit, and delete Issue Escalation Impacted Organizations.

Security Profile

Object: Issue Escalation Impacted Product

Ability to view, create, edit, and delete Issue Escalation Impacted Products.