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?
Other Details
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:
- Plan: Define the root cause
- Do: Research solution
- Check: Verify solution works
- Act: Implement the solution
