Using 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 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

Example: Quality Incident to Deviation

An employee at your organization, Peter Production, notices an issue with a piece of equipment while performing a routine maintenance procedure. Peter is unsure if the issue fits all the necessary criteria for a deviation. In this case, Peter could add a Quality Incident record, including any supporting material such as photos of the equipment and a description of the possible issue.

Another employee, Quincy Quality, can then triage Peter’s quality incident and determine whether it meets the requirements to become a true deviation or not. In the event that the incident is determined to be a true deviation, Quincy can change the state of the Quality Incident record to, for example, Requires Quality Event, automatically creating a new related Deviation record. When Vault creates the resulting Deviation record, it copies attachments and other information from the originating Quality Incident to the Deviation.

Creating & Managing Quality Incidents

You can create and manage Quality Incidents like other object records in Vault. Once evaluation and triage of a Quality Incident is complete, the record is typically either closed or promoted to a state that automatically creates a related quality event, such as a Deviation or Nonconformance, for further processing.

Depending on the configuration set up by your Vault Admin, the lifecycle of Quality Incidents may automate quality event creation upon entering certain Quality Incident Lifecycle states.

Generating Quality Incident QR Codes

To create a QR code for use in Quality Incident intake, perform the Generate Quality Incident QR Code user action on the Quality Incident Configuration Data object record. You can use your browser’s print dialog to save or print the QR code. Click Copy Link to URL to copy the QR code’s URL to your clipboard. Users with the ability to generate this QR code in Vault can this URL to provide easy navigation to the same Quality Incident creation page as the QR code.  For example, the URL can be made available to users in company portals.

Creating a Quality Incident with a QR Code

If configured by an Admin, you can scan QR codes provided by your organization in your environment to expedite the creation of Quality Incident records:

  1. Scan the QR code with a mobile device scanner, typically the device’s camera app.
  2. When you tap the resulting URL link, you may need to log in to Vault if the device has not already been logged in.
  3. On the intake form, some data may already be filled in for you. Enter the remaining data on the form.
  4. Add any attachments from your mobile device to the intake form.
  5. Tap Submit.

If another Quality Incident is necessary, tap Submit Another Incident.

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

To generate QR codes, users require Execute access to perform the Generate Quality Incident QR Code user action on Quality Incident Configuration Data records.