1. Medical Devices QMS
  2. Features
  3. Nonconformances and corrective actions
Feature · Nonconformances and corrective actions

Nonconformances and corrective actions

Keep failed inspection scope, containment, root cause and effectiveness review connected.

OverviewInspections awaiting review
Medical Devices QMS · Nonconformances and corrective actions

Inspections awaiting review

Approval conditions

New
Inspection numberSubject referenceInspection typeAssigned toStatus
INS-29985Review ins-420IncomingReview
INS-19314Review ins-562In processReview
INS-13596Review ins-430FinalReview
INS-87003Review ins-430ServiceReview
INS-13290Review ins-663IncomingReview
6 of 6 records
Review ins-420Inspections · INS-29985
Incoming
StatusReview
Example screen with sample data

What you can do

Carry a failed inspection into a controlled response

A rejected inspection can raise a nonconformance for the failed scope. The issue records when it was detected, its severity and a description, while its link to the inspection preserves the original evidence. The quality team can follow the issue through containment, investigation and disposition. A corrective action then holds the root cause, the approved action, its owner and the due date.

The reviewer and the action owner have different jobs. The owner investigates and carries out the response. The reviewer decides whether the planned action is acceptable and later whether its effect is sufficient to close the action. That final decision is more than a completion date: the workflow sends the action to effectiveness review before closure.

How the work is organized

  • Source. The nonconformance points to the inspection that exposed the failed requirement or scope.
  • Investigation. Severity, description and detected date help the reviewer and owner agree what must be contained and explained.
  • Action. Root cause, action, owner and due date keep the intended correction visible through implementation and effectiveness review.

Consider a final inspection with a failed labeling requirement. The Quality Reviewer rejects that failed scope and opens a linked nonconformance. The Corrective Action Owner records the cause and the action to correct the process. After the action is approved and implemented, the owner submits the action for effectiveness review. The reviewer accepts effectiveness before closing the action.

What to agree during setup

Agree who may set severity and who decides containment and disposition. Define what evidence the owner must submit with a corrective action and who can approve it. Decide how the team records a failed effectiveness review so the owner can address it before closure. Keep the inspection and the nonconformance linked instead of creating a separate, unexplained issue.

Set a practical due-date rule for the pilot. The due date helps the team focus follow-up, but it does not substitute for a review of the action. Identify which person is accountable for each action and make sure the reviewer is able to inspect the original failed check.

Check the handoff on an actual case

Start with one failed inspection check and follow its inspection into the nonconformance. Confirm that the issue has the correct inspection, severity and description. Let the Corrective Action Owner record the root cause and action, then ask the Quality Reviewer to decide the planned response. Move the action through implementation and effectiveness review. Inspect the same record after closure to confirm that the owner, cause, action and decision remain together.

Repeat the review from the perspective of someone who did not perform the inspection. They should be able to understand the failed requirement and why the action was accepted without searching for an unrelated case. Review an overdue action separately so the owner and reviewer can see what still needs a decision.

What your team sees

  • Open nonconformances — Issues in containment, investigation or disposition with their linked inspection.
  • Active corrective actions — Planned, approved and implementing actions by owner and due date.
  • Corrective actions for effectiveness review — Completed responses waiting for the reviewer’s closure decision.

Follow the work through

What it keeps track of

Data model
Nonconformances
Quality issues raised from failed inspection scope
Corrective actions
Corrective and preventive actions for nonconformances
Inspections
Incoming, in-process, final and service inspections
Inspection checks
Individual requirement checks captured during an inspection
People
Quality staff, inspectors and approvers

Who uses it

Permissions
Quality Reviewer
Decides disposition and effectiveness.
Corrective Action Owner
Investigates and carries out the response.
Inspector
Supplies the original inspection evidence.

Set up Medical Devices QMS your way.

Start free, then use Proto to change fields, steps and approvals before your team goes live.

How to get started