Quality events and CAPA, from report to effectiveness review

Log a quality event, assess patient impact, find the root cause, carry out corrective action, and check later that the fix worked.

A quality event is anything that went wrong or could have: a QC or proficiency testing failure, an instrument issue, an SOP deviation, a complaint, a specimen error. Legion Diagnostics takes each one from the first report through corrective and preventive action (CAPA) to a later check that the fix held.

Logging an event

Under "Quality management", open "Events" and click "New Quality Event". Record the site group and subspecialty, the event type, severity, a title and description, when it happened, who reported it (a member, or anyone else by name), and who it is assigned to.

Event types are QC failure, PT failure, Instrument issue, SOP deviation, Audit finding, Inspection deficiency, Customer complaint, Specimen error, Safety event, Validation issue and Other. Severity is Minor, Major or Critical, or a label of your own.

Context links tie the event to the records it involves: analytes, analyzers, lab areas, effective SOPs, completed experiments, training, plans, tasks, QC lots and QC reports, or an uploaded PDF. You choose each link, so the event only points at real records.

Events can also start elsewhere. A failed proficiency testing review, a QC rejection and a survey deficiency each offer to open an event with the details filled in.

Working the event

The event page walks through the steps in order:

1. "Overview" shows the event, its timeline and its links.
2. "Patient / specimen impact" records whether any reported results were affected, plus specimens, patients, amended reports and provider notification.
3. "Investigation" holds notes on what happened, with a list of questions worth answering.
4. "Root cause" records a category (personnel, procedure, equipment, reagent, software, environment, specimen, communication, unknown or other) and the reasoning behind it.
5. "Corrective action" records what was done, as corrective action notes, as tasks assigned to people in my queue, or both. The step is complete once there is at least one task or a note. Tasks can still be in progress when you move on; they only have to be finished or revoked before the final sign-off. Revoking a task asks for a reason, which is kept on the event's timeline. The person the event is assigned to manages it, and their assignment is not a corrective action.
6. "Monitoring metrics" sets a checklist of what to check later to show the fix worked, the date the event reopens for that review, and the one reviewer who checks it then.
7. "Finalize & sign" is where everyone you assign signs off on the whole CAPA. It stays locked until the monitoring review is done, and the tab lists what it is still waiting on.

Save is always available and saves every step at once. The footer tells you what the open step still needs.

Starting the monitoring period

Once steps 1 to 6 are complete, choose whether anyone should sign off on them before monitoring begins. If you choose Yes, assign the people who sign; they all have to sign first. Then click "Begin monitoring period" and confirm. A banner at the top of the event says the monitoring period has started and that steps 1 to 6 are locked until the reopen date.

During the monitoring period

The one thing still open is "Monitoring notes" on the Monitoring metrics step. Add a dated note whenever you observe something worth recording, such as another QC failure or a retraining. Each note keeps who wrote it and when, and only its author can edit or delete it. The reviewer can also be changed, for example when someone goes on leave.

Checking effectiveness

On the reopen date the reviewer gets a task in my queue. They read the monitoring notes, check off each checklist item, note what they observed, and write the effectiveness notes: how the monitoring period went and whether the fix held.

When the review is done and every action task is finished or revoked, "Finalize & sign" opens. Add follow-up evidence there: link the records that show the corrective action was carried out, such as the revised SOP, the training assignment or a repeat experiment, or upload a PDF. The links made during the investigation stay as they were. Then assign everyone who signs off on the CAPA. The event closes as effective when the last of them signs. The checklist, the monitoring notes, the effectiveness notes and the follow-up evidence lock once anyone signs.

If the fix did not hold, mark it not effective on "Finalize & sign" and create a follow-up event instead of signing. The follow-up keeps the original's type and scope and links back to it. The original closes as not effective once the follow-up exists.

Lists and records

The events list shows each event's number, type, site group, subspecialty, status, dates, reporter and assignee, with search across all of them. Statuses run from "Under review" to "Monitoring period" to "Closed". Each event has an audit trail you can download as a PDF, and archived events can be restored.