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NC/CAPA Quick Reference Guide

There are vital things to consider about your NC or CAPA record, and here is an easy reference guide. Ask yourself these questions about your record:

Understanding the Description

  • What happened?
  • When did it happen?
  • What specifications were not met?

Understanding the Scope

  • What parts/processes were affected?
  • What production lots were involved?
  • How many affected parts/processes?
  • Do you have all the evidence needed to support the scope of the NC/CAPA?

Understanding the Containment

  • What activities were taken to contain the scope of the non-conformance?
  • Do you have all the evidence needed to support the containment of the NC/CAPA?

Understanding the Root Cause or Immediate Cause

  • What is the immediate cause or root cause of the NC/CAPA?
  • How was this immediate cause or root cause determined?

Understanding the Corrective Action and Correction

  • What actions were taken to correct the non-conformance?
  • Do you have all the evidence needed to support the correction of the NC/CAPA?

Definitions

NC: Non-conformance

CAPA: Corrective Action and Preventive Action

Corrective Action: This is an action taken to eliminate the cause of a non-conformance, to prevent it from recurring.

Preventive Action: This is an action taken to prevent the occurrence of a non-conformance.

The result of a risk analysis often recommends a preventive action.

Process

Use “Plan-Do-Check-Act” (PDCA) in processing your quality record to closure:

  1. Plan: Define root cause
  2. Do: Research solution
  3. Check: Verify solution works
  4. Act: Implement the solution

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