1. Pharmaceuticals QMS
  2. Features
  3. Nonconformances
Feature · Nonconformances

Nonconformances

Keep each detected issue linked to its inspection while the team contains, investigates and disposes it.

OverviewMy inspections
Pharmaceuticals QMS · Nonconformances

My inspections

Inspections

New
Inspection numberSubject referenceScheduled atStatus
INS-83416Planned ins-92619 OctPlanned
INS-69227In progress ins-62422 OctIn progress
INS-83707Review ins-94325 OctReview
INS-70525Accepted ins-66924 OctAccepted
INS-73102Rejected ins-87409 OctPlanned
6 of 6 records
Planned ins-926Inspections · INS-83416
Planned
Scheduled at19 Oct
Example screen with sample data

What you can do

Give the issue an inspection context

A Nonconformance points to the Inspection where the issue was found. It carries a detection date, severity, description and status. That connection lets a Quality Reviewer return to the check observations when deciding what happened, instead of managing a detached defect list. Minor, major and critical are the available severity choices. The team can use the same case structure whether the issue began with an incoming inspection or a later quality check.

The issue lifecycle separates open work, containment, investigation, disposition and closure. Those labels give the team a common queue. The evidence behind the decision remains in the source inspection and linked corrective actions. If a check failed, leave that check intact. Use the nonconformance to document the follow-up context and attach the owner of a corrective action through the action record.

How the work is organized

  • Detection. Tie the issue to the exact inspection and capture when and how it was found.
  • Classification. Assign severity consistently so urgent work is visible in the same queue as routine follow-up.
  • Resolution. Track the issue’s current state and inspect every linked corrective action before closure.

What to agree during setup

Define examples for minor, major and critical that fit the products and processes your team actually inspects. Agree when an open issue has been contained and who makes that call. The status alone cannot describe the containment decision, so write a clear description and keep the related inspection evidence available to the reviewer. Decide how a disposition is documented in the description and in any linked actions. Name the Quality Reviewer who coordinates the issue and the Corrective Action Owner who performs each assigned remedy.

Establish a rule for cases with several linked corrective actions. The parent issue stays open until every action has been reviewed and accepted. That rule prevents a team from closing an issue after the first owner finishes while another action still needs effectiveness review.

Check the handoff on an actual case

Use an inspection with a failed requirement. Create a linked nonconformance, enter the detection date, severity and a description that identifies the affected subject. Have the Quality Reviewer compare it with the original check observation. Assign a corrective action to a named owner with a due date. When the first action reaches effectiveness review, look for other linked actions before closing the parent. A reviewer should be able to move from the issue to the inspection and back without guessing which case produced the work.

For a critical issue, inspect the open nonconformance queue together with the source inspection. This reveals whether the classification matches the observed problem and whether the current state accurately reflects the team’s containment work.

What your team sees

  • Open nonconformances — Issues in active states with detection date, severity and linked inspection.
  • Corrective action work — Assigned remedies and due dates for issues that need work.

Follow the work through

Follow inspection execution into corrective action when an issue needs a documented remedy.

What it keeps track of

Data model
Nonconformances
Nonconformances records for Quality & Compliance (Source).
Inspections
Inspections records for Quality & Compliance (Source).
Inspection checks
Inspection Checks records for Quality & Compliance (Source).
Corrective actions
Corrective Actions records for Quality & Compliance (Source).

Who uses it

Permissions
Quality Reviewer
Coordinates containment, investigation and closure.
Inspector
Supplies the source inspection evidence.
Corrective Action Owner
Performs the assigned correction.

Set up Pharmaceuticals QMS your way.

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

How to get started