Non conformance (NC) or Corrective & Preventive action (CAPA)

[Raja Gurung]

If some one lost the batch records then QA department should issue NC or CAPA?

 

[guna8184]

I am very curious here.
What is the CAPA for this issue if records are missing.

 

[John Broomfield]

The system that caused this loss probably needs corrective action to stop recurrence. So, why raise an NC when every Corrective Action Request also includes a description of the nonconformity’s:

A. Nature
B. Requirement not fulfilled
C. Evidence requirement was not fulfilled.

It may also include a description of the consequences of the NC to share the benefits of risk-based thinking as in no consequence = why keep the record, for example.

BTW, the PA part of your CAPA may cause folk to think preventive action is stopping recurrence when it is action to prevent occurrence. Proper PA usually follows the analysis of data to see trends or planning with due regard for risk.

 

[guna8184]

I agree with you John on the explanation and action to be taken.

But if records are missing and should there be market complaint then the organization have to bear serious consequences.
Records if stored electronically in server should always have backup to avoid data lost.

 

[John Broomfield]

Agreed.

On completing your corrective action perhaps you could update us on why the system failed to keep the batch records and what you did to stop recurrence.

Thanks.

 

[silentmonkey]

Yes either an NCR or a CAPA should be issued to investigate and address the problem. Depends how your organisation manages NCRs or CAPAs. Are they the same thing? Does an NCR always result in a corrective/preventive action? Whichever system you use to manage the non-conformity, you should at least address the following to assure the problem is adequately eliminated:
- Identify problem
- Containment (if applicable)
- Risk/Impact Assessment - could you have more missing batch records?
- Root cause analysis
- Corrective/Preventive Action

 

[John Broomfield]

I’ve always seen NCRs used to disposition nonconforming items as in justifying and seeking approval for one of these actions:

1. Scrap and replace
2. Rework to original spec
3. Repair (a design change)
4. Use as is (a design change)

The NCR may refer to a CAR.

 

[silentmonkey]

Ah yes, forgot about Disposition!