Manage a deviation

A deviation is any departure from an approved process, procedure, or specification. This guide takes one from first report through evaluation, correction, and disposition, to a signed closure, with the CAPA, task, and cancellation paths along the way.

A deviation moves through a fixed set of statuses from report to closure.

Record a deviation

1. Open the Deviations space, click the Quality Events tab, then the Deviations sub-tab, and click + New deviation.
   You can also reach a deviation from the space All work tab, filtered on the Deviation work type.

   

2. Select the Deviations (DEV) space and the Deviation work type, then enter a summary and a description covering what happened, when, where, who was involved, how many units are affected, and how it was discovered.
   The deviation is created in Identification. You can transition back to it from any other status if you need to start over.

   

3. Choose a category such as Product, Process, Material, System, Regulatory, Documentation, Environmental, or Safety.

   

4. Set market surveillance to Pre-Market or Post-Market, mark whether the deviation is planned, set the priority, and set a due date.

   

5. Link the trigger that surfaced the deviation, whether that is an incoming inspection, a batch item, a serialized item, a customer complaint, an audit finding, an asset, or another quality event.

   

6. Link the affected items involved, whether that is a product, device, assembly, part, batch item, serialized item, software system, or software item.

   

7. Assign the deviation to the person responsible for it.
8. Once the deviation is sufficiently documented, click Evaluate to move it from Identification to Evaluation.
   The description field is required for this transition.

   

Evaluate the deviation

1. Open the deviation and fill in the evaluation with the impact on product quality, patient safety, process integrity, and regulatory compliance, plus the scope (how many units, and whether they have left the facility) and the severity.

   

2. Click Immediate action to move the deviation from Evaluation to Immediate corrective action.
   The evaluation, category, and priority fields must all be filled in before you can make this move.

   

Take immediate corrective action

1. Document the containment or correction in the immediate corrective action field. This might mean alerting the quality team, moving affected items to temporary stock, or another action that stops the deviation from causing further harm.
2. Click Root cause to go to Root cause analysis, or Skip to disposition to go straight to Disposition, if a root cause analysis is not needed.

   

Analyze the root cause

1. Open the deviation and go to the Root cause & escalation tab.
2. Document the investigation method (5-Why, Ishikawa, or another), the findings, and the root cause in the root cause analysis summary field.
   You can do the analysis in a controlled document instead. If you do, link it in affected documents and still put the conclusion in root cause analysis summary, because that field is what the transition checks. See Create a document or template if you need to start one.

   

3. Click Escalate to move to CAPA escalation, or Do not escalate to go straight to Disposition.

   

Escalate to a CAPA

1. Use the escalated to CAPA field to create a new CAPA or link an existing one.
   The CAPA runs its own lifecycle from here, independent of the deviation. The deviation carries on with its own, through disposition, closure, and closed. See Manage a CAPA for that procedure.

   

2. Click Proceed to disposition.

Decide the disposition

1. Open the deviation. If disposition work needs tracking, create one or more tasks from it. Tasks are covered later in this guide.
2. If a concession is needed, use the resulting concessions field to create one or link an existing one. See Manage a concession for that procedure.

   

3. Enter the justification, covering the assessment of the impact, which disposition path you chose (rework, scrap, use-as-is, return, or another), why that path is acceptable, and the acceptance or rejection criteria applied.

   

4. Enter the verification, covering confirmation that the tasks and actions were carried out, the test or inspection results, evidence that the affected items were handled per the justification, and references to supporting records.

   

5. Set the closure approvers, then click Close to move the deviation from Disposition to Closure.
   Justification, verification, and closure approvers are all required for this transition.

   

Close the deviation

1. Open the deviation once it is in Closure.
2. Fill in the effectiveness check, describing how the corrective actions taken have eliminated or controlled the deviation and prevented recurrence.

   

3. Fill in the closure remarks with a summary of the deviation, lessons learned, or any residual risk accepted.

   

4. Every closure approver gets an email. Each approves separately: click Reject or Approve, add a comment if needed, then enter the one-time password sent by email.
   The one-time password is what records the signature, not the button click.

   

   

5. Once every approval is in, the deviation moves to Closed on its own.
6. If any approver rejects, the deviation moves to Closure reject on its own. From there, it goes back to Identification to be revised and re-routed.
   A closure is typically rejected when QA finds the content thin, or when tasks are still open.

Resume an overdue closure

If the closure approval runs past the configured period, an automated Closure overdue transition moves the deviation from Closure to Closure overdue, and notifies whoever is configured to hear about it.

1. Open the deviation once it has moved to Closure overdue.
   The period, and who gets notified, are configured per project. See Set up Quality Events.

   

2. Investigate why the approval was not completed in time (an approver was unavailable, more information was needed, or an action is still outstanding), then document it in the overdue justification field.
3. Check the due date. It resets automatically, so change it if the new date does not fit.
4. Click Justify & resume to return the deviation to Closure and restart the approval cycle.
   Overdue justification is required for this transition.

   

Cancel a deviation

1. Open the deviation, in any status.
2. Click Cancel.
   Only a user with the Quality Events Administrator role can do this. A canceled deviation cannot be edited, and the only route back is to Identification.

   

Track the work with tasks

1. Create a task from the deviation’s Actions field. It links to the deviation automatically.

   

2. Assign the task, set a due date, set the type (Disposition or Corrective action), fill in the description with the scope and acceptance criteria, and set the approvers.

   

3. The assignee clicks Start to move the task from To do to In progress.

   

4. Fill in the verification field with the work performed and the outcome, then click Review to move the task to In review.
   Type and approvers are both required for this transition.

   

5. Each reviewer approves the same way as a deviation closure: click Reject or Approve, then enter the one-time password sent by email.
6. Done is read-only. If rework is needed, the reviewer clicks Reject, which sends the task to Reopened. The assignee then clicks Restart to return it to In progress.
7. If a review sits too long, an automated transition moves the task to Overdue. Fill in overdue justification and click Justify & resume to return it to In review.
8. Canceling a task follows the same rule as canceling a deviation: only a Quality Events Administrator can do it, from any status.