Manage a nonconformity

A nonconformity tracks nonconforming product, from the moment it is caught to a closed, signed disposition. This guide walks through recording one, working it through evaluation and containment, and closing it once every approver has signed.

A nonconformity is nonconforming product, a part, a batch, or a device that does not meet its own requirements. A deviation is different. It is a departure from a process, not from the product itself. See Manage a deviation if that is what you are looking at.

Record a nonconformity

1. Open the Nonconformities (NC) space, click the Quality Events tab, then the Nonconformities sub-tab.
   To see nonconformities across every Quality Events space at once, use the Jira side menu, Apps, then Quality Events.

   

2. Click + New Nonconformity.

   

3. Set space to Nonconformities (NC) and work type to Nonconformity, then enter a summary and a description of what failed to meet requirements. Use the description to note the immediate corrective action too, if you already know it.

   

4. Click Create.
   A nonconformity is created in Identification. You can transition it back to Identification from any other status if it needs to be reworked.

Evaluate the nonconformity

1. On the Identification & Evaluation tab, select the category, one of Product, Process, Material, System, Regulatory, Documentation, Environmental, or Safety, set market surveillance to pre or post, and set priority and due date according to impact and urgency.
   You can also reach a nonconformity from the space All work tab, filtered on the Nonconformity work type.

   

2. Assign the nonconformity to whoever will run it.
3. On the Trigger tab, link what surfaced the nonconformity: an incoming inspection, a batch item, a serialized item, a customer complaint, an audit finding, an asset or piece of equipment, or another quality event.

   

4. On the Nonconforming Item tab, link the affected product, device, assembly, part, batch item, serialized item, software system, or software item.

   

5. Once the record is documented enough, click Evaluate to move it to Evaluation.
   Description is required for this transition.

   

Take immediate corrective action

Immediate corrective action contains or fixes the nonconformity to stop further use, release, or impact, for example by segregating the affected items or moving them to temporary stock. It is not automatically a CAPA. It addresses only this specific case, with no root cause analysis, systemic correction, prevention, or effectiveness check.

1. Fill in the evaluation field with your assessment, and confirm category and priority are set.
2. Click Immediate action to move the nonconformity to Immediate corrective action.
   Evaluation, category, and priority are all required for this transition.

   

3. Update the description with what you contained or fixed, whether that means segregating the affected items or moving them to temporary stock.
4. Choose Root cause to start a root cause investigation, or Skip to disposition when one is not needed.

   

Analyze the root cause

1. Fill in root cause analysis summary with what you found.
   You can run the analysis in a controlled document instead. If you do, link it in affected documents and put the conclusion in root cause analysis summary.

   

2. Choose Escalate to send the nonconformity to a CAPA, or Do not escalate to go straight to disposition.
   Root cause analysis summary is required for every transition out of Root cause analysis, whichever way you go. Use it to justify the decision.

   

Escalate to a CAPA

Skip this section if you chose Do not escalate in root cause analysis.

1. Use the Escalated to CAPA link field to create a new CAPA, or link an existing one.

   

2. Click Proceed to disposition to move on.

Decide the disposition

1. On the Disposition tab, set disposition strategy, for example Use as is, Rework, or Reject or scrap, describe what was actually done in disposition, and give your reasoning in justification.

   

1. Set closure approvers to whoever will sign off on the closure.

   

2. For a rework or repair disposition, create tasks to track the implementation. See Track the work with tasks, further down this guide. They must be completed before the nonconformity can be closed.
3. Link any related records that need the connection: concessions, deviations, CAPAs, affected documents, products, or change requests.
4. Once disposition strategy, disposition, justification, and closure approvers are all set, click Close to move the nonconformity to Closure.

   

Close the nonconformity

1. Fill in effectiveness check with how you confirmed the corrective actions worked.

   

2. Fill in closure remarks with anything else worth recording, such as lessons learned or an accepted residual risk.

   

3. Every closure approver gets an email, then approves individually. Click Reject or Approve, add a comment if you want to, then enter the one-time password sent to your email.
   The password is what records the signature, not the click.

   

   

4. When every approval is in, the nonconformity moves to Closed on its own.

   

Resume an overdue closure

If the closure approval runs past the configured period, an automated Closure overdue transition moves the nonconformity from Closure to Closure overdue, and notifies whoever is configured to hear about it. The period and the recipients are set in Set up Quality Events.

1. Open the nonconformity and find out why the approval stalled, such as an approver being unavailable or more information being needed.
2. Fill in overdue justification with the reason for the delay.

   

3. Check the due date. It resets automatically, so change it if the new one is not right.
4. Click Justify & resume to return the nonconformity to Closure and restart the approval cycle.
   Overdue justification is required for this transition.

   

Cancel a nonconformity

1. Open the nonconformity. It can be canceled from any status between Identification and Closure overdue.
2. Click Cancel.

   

Track the work with tasks

A rework or repair disposition needs its own record of the work, tracked and signed separately from the nonconformity itself.

1. From the nonconformity, open the Disposition actions link field and create a task, or link an existing one. It links back to the nonconformity automatically.

   

2. Assign the task and set a due date.
3. Set type to Corrective action or Disposition.

   

4. Fill in description with the scope and the acceptance criteria, and set approvers to whoever will review it.
5. The assignee clicks Start to move the task from To do to In progress.
6. Fill in verification with the work performed and the outcome, then click Review to move it to In review.
   Type and approvers are both required for this transition.

   

7. Each reviewer signs the same way: click Approve or Reject, then enter the one-time password.
8. If a reviewer clicks Reject, the task moves to Reopened. Click Restart to return it to In progress and address the feedback.
9. If the review sits too long, an automated transition moves the task to Overdue on its own. Fill in overdue justification and click Justify & resume to return it to In review.