Configuring Quality Incidents

The Quality Incident object and lifecycle allow your organization to triage an incident to determine if it is necessary to initiate a quality event. This avoids skewing quality event metrics, and unnecessarily complicating audits. Information from a quality incident can be automatically copied to a quality event, including attachments on the incident that represent pictures and video documenting the incident.

Supported Objects

Quality Incidents are currently supported for the following objects:

  • Quality Event
  • Change Control
  • Complaint
  • Continuous Improvement
  • Deviation
  • Lab Investigation
  • MedTech CAPA
  • Nonconformance

Configuring Quality Incidents

To allow users to utilize Quality Incidents effectively, we recommend the following configuration steps:

  • Create a Related Record Configuration for the Quality Incident object. In the configuration options, ensure that you select the Copy Attachments checkbox.
  • Configure the Create Related Record entry action on the Quality Incident Lifecycle, selecting the Related Record Configuration that you created in the previous step.
  • Configure a custom Quality Incident object tab for users to quickly access and manage Quality Incidents.
  • Configure Quality Teams for the Quality Incident object.
  • Optional: Configure Quality Incident Intake via QR codes if you want to allow users to create Quality Incidents from a mobile device using a QR code.

Enabling Quality Incident Intake Via QR Code

You can configure Vault QMS to provide QR codes to be printed and placed anywhere employees or contractors work to assist in Quality Incident intake and triage. Once placed, Vault QMS users can scan QR codes with their mobile device’s camera to fill out a streamlined page that collects required information about the incident they encountered. Individuals must have a Vault QMS license, and they will be prompted to log into a Vault if they don’t have an active session established. This feature utilizes a mobile device’s browser.

Complete the following configuration steps to set up QR-code-based Quality Incident Intake in your Vault:

  1. Add the special Quality Incident Layout Configuration field to the Quality Incident Configuration Data object page layout.
  2. Optional: Configure an approval workflow and lifecycle configuration for the Quality Incident Configuration Data object.
  3. Enable the Generate Quality Incident QR Code user action on the Quality Incident Configuration Data object lifecycle state associated with the Complete State type.
  4. Create a Quality Incident Intake Layout configuration.
  5. Create Quality Incident Configuration Data object records.

Configuring Quality Incident Intake Layouts

The Quality Incident Intake Layout configuration component determines which fields to display for input when a user scans a QR code to report a Quality Incident. To create a Quality Incident Intake Layout:

  1. Navigate to Admin > Configuration > Quality Incident Intake Layouts.
  2. Click Create.
  3. Enter the required details.
  4. Click Save.
  5. In the Fields to Display section, click Edit to change which fields the intake form will display when a user scans the QR code. Mandatory fields are displayed with an asterisk. A typical set of fields may include:
    1. Organization
    2. Facility
    3. Department
    4. Date Occurred
    5. Title
    6. Summary
  6. Click Save.

You can create multiple Quality Incident Intake Layout configurations, as some fields may be more useful in some locations or facilities than others.

Creating Quality Incident Configuration Data

Quality Incident Configuration Data object records represent QR codes associated with different areas of an organization’s operations. Create a record for each type of QR code you want to place. Each unique combination of Quality Incident Layout Configuration and Quality Incident Configuration Data allows for a different Quality Incident intake experience for the user.

Each Quality Incident Configuration Data record references a Quality Incident Intake Layout configuration. A QR code can be associated with specific values for any combination of the following fields on a Quality Incident record:

  • Country
  • Organization
  • Facility
  • Department

In each record, you must select a Quality Incident Layout Configuration. More than one Quality Incident Configuration Data record can reference the same Quality Incident Layout Configuration.

To create and manage Quality Incidents, users require Read, Create, and Edit permissions for the Quality Incident object.

To configure Quality Incident Layout Configurations, users require Create permission on the Admin tab for Quality Incident Intake Configuration, and View access on the Pages tab for the Quality Incident Create page.

To create Quality Incident Configuration Data records, users require a permission set that grants Create permission for the Quality Incident Configuration Data object.