Guide

Manage an improvement

An improvement records an opportunity to make something better, rather than a failure that has to be contained. ISO 13485 expects a quality system to act on opportunities for improvement, not only on things that went wrong, and this is the record that carries that work. It runs the same lifecycle as a deviation or a nonconformity, so if you have used either, this will feel familiar.

Improvements live in the CAPA space, alongside CAPA records, rather than in a space of their own. Open the Quality Events space tab there and select the Improvements sub-tab.

When to raise an improvement rather than something else

Use an improvement when nothing has failed. A deviation departs from an approved instruction, a nonconformity fails a requirement, and both are about something already wrong. An improvement starts from a chance to do better: a process that works but wastes time, a recurring irritation that has never breached a specification, a suggestion from an audit that was not a finding.

If the improvement turns out to need a systemic fix with a root cause behind it, you escalate it to a CAPA rather than reclassifying it. The improvement stays open and keeps its own record.

What goes in each tab

Tab	What it holds
Details	The Summary, the Description, the Category that classifies it, and the Evaluation of what the opportunity is worth.
Triggers	What surfaced it: linked nonconformities, deviations, adverse events, customer complaints, and audit findings. Which of these appear depends on which spaces exist on your site.
Affected items	The Product and Part the improvement applies to. Present when Product Lifecycle Management is installed.
Root cause & escalation	The Root cause analysis summary, whether it was escalated to CAPA, the documents it affects, and any deviations that resulted.
Implementation	The Actions carried out as tasks, any resulting changes and concessions, and the Verification that the work was done.
Closure	The Effectiveness check, the Closure remarks, and the Overdue justification if an approval ran late.
General	The Assignee, Reporter, Priority, Due date, Closure approvers, and the Approvals field the signatures land on.

The statuses an improvement moves through

IDENTIFICATIONRaised, and being described. The starting status, and the one a reopened improvement returns to.

EVALUATIONBeing assessed for what the opportunity is worth and how it should be classified.

IMMEDIATE CORRECTIVE ACTIONAnything that needs doing straight away. Skip through to implementation when there is nothing to contain.

ROOT CAUSE ANALYSISInvestigating what sits behind the opportunity, where that matters. Skippable.

CAPA ESCALATIONHanded to a CAPA because the fix is systemic. Optional.

IMPLEMENTATIONThe actions are being carried out and verified.

CLOSUREOut with the closure approvers for signature.

CLOSURE REJECTAn approver rejected the closure.

CLOSURE OVERDUEThe closure approval passed its time limit. Fill in the Overdue justification and use Justify & resume to return it to Closure.

CLOSEDApproved and closed. Read-only.

CANCELEDDropped without completing. Read-only, and only a Quality Events Administrator can cancel a record.

Raise and evaluate an improvement

In the CAPA space, open the Quality Events tab and select the Improvements sub-tab.
Create an improvement and give it a Summary and a Description.
The Description has to be filled in before the improvement will move to Evaluation.
On the Triggers tab, link whatever surfaced the opportunity: a nonconformity, a deviation, an adverse event, a customer complaint, or an audit finding.
Move it to Evaluation, then record what the opportunity is worth in the Evaluation field and set the Category.
Set the Priority to something other than Undefined, then move the improvement on.
The Evaluation and Category fields are both required to leave this status, and a priority still set to Undefined blocks the transition on its own.

Decide whether it needs a CAPA

Take any immediate action the opportunity calls for, or move straight to implementation when there is nothing to contain.
Where the opportunity has something systemic behind it, work through Root cause analysis and write the Root cause analysis summary.
That summary is required whichever way you go next, to escalate or not to escalate.
Choose Escalate to hand the systemic fix to a CAPA, or Do not escalate to implement the improvement on its own.
An escalated improvement moves on to implementation once the CAPA has taken over the systemic part.

Implement and close

On the Implementation tab, carry out the Actions as tasks and record the Verification that they were done.
Add the Closure approvers, then move the improvement to Closure.
Closure approvers are required for this transition. Nothing closes without a named signatory.
Each approver responds Approve or Reject on the Approvals field and confirms with the one-time password sent to their email.
Once approved, the improvement moves to Closed and becomes read-only.

A Closed or Canceled improvement cannot be edited. Either can be moved back to Identification, which is the only route back in, and only a Quality Events Administrator can cancel one at all.