Creating & Assessing Deviations

A Deviation record is typically created as soon as the site becomes aware of a deviation. In many cases, not much information is known at the time the deviation is discovered, such as the severity of the deviation or its root cause. When you create a Deviation record, you assign the record an Owner who is responsible for much of the deviation assessment and related record creation. The Owner reviews the Deviation record and selects its Rating (Minor, Major, or Critical), which determines the workflow for documenting information for the deviation.

Creating Deviations

To initiate the Deviation process, create the Deviation record and assign the appropriate Owner and QA Approvers.

Complete the following steps to create a new Deviation:

  1. In Quality Events > Deviations, click Create. 
  2. Enter the Title of the deviation.
  3. Enter a detailed Description of the deviation.
  4. Select the deviation Category.
  5. Enter the Occurrence Date when the incident occurred.
  6. Enter the Awareness Date when the organization became aware of the incident.
  7. Select whether the deviation was Internal (within the organization) or External (related to a supplier or other external party). By default, the deviation investigation and approval are due in 30 days for Internal deviations and 45 days for External deviations. An Extension Request can be created to adjust the due date. 
  8. Select the Owning Facility responsible for managing the deviation.
  9. Select the Owning Department responsible for managing the deviation.
  10. Optional: Select the Study associated with the deviation and enter any Corrections & Immediate Actions Taken when the deviation was initially discovered.
  11. Click Save. Vault assigns the Deviation a Record Number, creates the Deviation record with the status of Define Team, and opens the Deviation page.
  12. Expand the Team section and click Manage Team.
  13. Select the Owner responsible for completing the deviation details and select one or more QA Approvers responsible for approving the deviation details and investigation, if applicable. A QA Approver cannot be the same user as the Owner.
  14. Click Save to save the selected team members. Vault updates the Deviation status to In Assessment and assigns a Complete Assessment task to the Deviation Owner.

Running Recurrence Checks

Recurrence Checks allow you to compare a newly created Deviation with existing Deviations to determine if the Deviation has occurred before. For recurring Deviations, you may need to create different CAPA Actions to address the recurring issue than you would create for a Deviation that has only happened once. 

Complete the following steps to run a Recurrence Check:

  1. Open the Deviation on which you want to run a Recurrence Check.
  2. From the Actions menu, select Run Recurrence Check. Vault displays the Run Record Check dialog with a list of Suggested Match Terms based on the Deviation’s Title and Description.
  3. Select the Type of Recurrence Check. The Match Criteria are displayed for the selected Type. 
  4. In the Suggested Match Terms box, click the remove (x) icon to remove any terms that are not applicable.
  5. Click Continue. Vault displays a list of matching Deviation records. 
  6. Review the Deviation, select the appropriate Relationships, and enter Justification details for each record. 
  7. Click Review and review the Recurrence Check results. 
  8. Click Complete. Vault creates Related Event records for each Deviation you selected using the Relationship you selected.

Assessing Deviations

The next steps in the Deviation process depend on the Deviation Rating: Minor, Major, or Critical. The Deviation Owner determines the Rating when completing the assigned Complete Assessment task.