Manage a concession

A concession is a documented authorization to use or release a product, component, or material that departs from its requirements, limited in scope and in time. It is the simplest of the four Quality Events record types: no tasks, no disposition, and no effectiveness check, and the only one that carries a validity period. If Manage a nonconformity sent you here because its Use as is disposition called for one, this guide covers the concession itself from here.

The lifecycle is short. It runs Draft → In review → Approved, then either Withdrawn or Expired. Rejected, Approval overdue, and Canceled are the side statuses you can land in along the way.

Record a concession

1. In the Concessions (CONC) space, open the Quality Events tab, then its Concessions sub-tab, and click + New Concession.
   You can reach every Quality Events space at once from the Jira side menu, under Apps, then Quality Events.

   

2. The summary should say what is being accepted under concession, which specification it departs from, and which batch or lot is affected.

   

3. The description should cover what is non-conforming, from which requirement, the measured value against the specified one, how many units are affected, why the concession is justified, and the time or quantity limit.

   

4. Click Create. The concession opens in Draft, with a key such as CONC-1.

Enter the details

1. Open the concession from the Concessions view.
   You can also reach it from the space’s All work tab, filtered on the Concession work type.
2. Set the priority to Highest, High, Medium, Undefined, Low, or Lowest.

   

3. Set the validity period, a start date when the concession becomes active and an end date when it expires.
4. Enter the justification, fill in market surveillance if it applies, set the assignee, and add a due date, the target date for the approval to finish.

   

5. On the Trigger tab, link the source event that triggered the concession: a linked nonconformity, deviation, or CAPA.

   

6. On the Affected items tab, identify what the concession covers: a batch, a serialized item, or an asset.

   

7. On the Implementation tab, link supporting material: affected documents and any related risks.
   Affected documents come from Document Control. Linked risks come from the Safety Risks app, not covered on this site yet.

   

8. Fill in the approvers field.
   If approvers is empty, nobody is invited when you start the review.
9. Click Start Review to move the concession to In review.
   The description field must be filled in first, or the transition will not go through.

   

Approve a concession

Each approval is signed with a one-time password sent by email. That is what makes it a signature, not just a click on Approve.

1. Open the concession that is awaiting approval.
2. Each approver acts individually, on the Approvals field. It carries an Approval required lozenge, a Comment box, and Reject and Approve buttons. Add a comment if you need to, then click Reject or Approve.

   

3. Enter the one-time password sent to your email.

   

4. Once the password is verified, your decision is recorded on the concession.

   

5. When every approver has signed, the concession moves to Approved.

Revise an approved concession

An approved concession is read-only. To change one, take it back to Draft, which means it has to be approved again.

1. Open the approved concession you want to revise.
2. Click Revise to move it from Approved to Draft.
   Only a user with the Quality Events Administrator role can make this transition.

   

3. Change what you need, then fill in the approvers field again.
4. Click Start Review to move it back to In review, and run the approval again: each approver clicks Approve or Reject, then enters the one-time password, the same as before.

Withdraw a concession

1. Open the approved concession you want to withdraw.
2. Enter a justification explaining why the concession is being withdrawn.
3. Click Withdraw to move it to Withdrawn.

   

Let a concession expire

Every concession carries a validity end date, but reaching that date does not close the record on its own. Expire it explicitly once its validity period has run out.

1. Open the approved concession.
2. Click Expire to move it to Expired.

   

Cancel a concession

Cancel drops a concession that turns out not to be needed, before it ever reaches Approved.

1. Open the concession you want to cancel.
2. Enter closure remarks explaining why the concession is being canceled.
   This field is required before the concession can be canceled.

   

3. Click Cancel to move it to Canceled.
   Only a user with the Quality Events Administrator role can make this transition.

Resume an overdue approval

If review runs past the period configured in Quality Events admin settings, an automated transition moves the concession from In review to Approval overdue on its own, and notifies whoever is configured to hear about it.

1. Open the concession that is overdue.
2. Investigate why the approval was not completed in time, for example an approver was unavailable or more information was needed. Document the reason in the Overdue justification field.
   Overdue justification is required for the Justify & resume transition below.

   

3. Check the due date. It resets automatically, so change it if the new one does not fit.
4. Click Justify & resume. The concession returns to In review, and the approval cycle restarts: each approver clicks Approve or Reject, then enters the one-time password, the same as before.