3 replies to this topic

[kconf]

Hey all,

 

Just a quick simple question - Can the NC's received from internal audits be addressed without CAPA's?  

[nwilson]

For an internal audit any NC raised is an immediate CAPA (especially if gauging your site against a standard).  For general GMP Inspections any findings are addressed at the time of the finding (corrected on the spot), however still documented for trending purposes.  When I perform internal audits I try to put my auditor hat on and even if I know the process I make staff walk me through it to gauge their knowledge.  Any objective evidence that is not up to scratch is collected and if it is raised to a NC then this aids in continuous improvement.  

[jfrey123]

From your own internal audits?  Yes, depending on the nature and severity of the finding. 

 

Any finding that is a clear hazard to food safety or a symptom of a program failure should receive a full CAPA with root cause investigation.  But minor findings related to GMP issues, documentation issues, minor building maintenance issues, etc., can get a CA on the spot and move on.  Though all of your minor CA's should still be trended, and there should be a point where those trends can trigger a full CAPA.  Example that if a GMP audit repeatedly finds employees wearing nail polish or ear buds or something, in addition to observations of those behaviors between your monthly audits, then a full CAPA could help you discover why GMP's are not being followed: more training required?  Is a supervisor telling employees they don't care about it? 

 

Or maybe a forklift punches a hole in the wall, found during the routine facility audit.  I'd mark it and write a work order to repair and call it solved.  But if I keep finding forklift holes in the wall, then I'm going full CAPA to figure out what the hell is happening and determine if maybe some type of barriers should be installed in areas.

[Tony-C]

Hi kconf

 

 Corrections CA & PA.png   1.19MB   2 downloads

 

Non-conformances identified in internal audits may be addressed in one of two ways:

1. Correct the problem by implementing a solution and documenting both the problem and the solution. This is known as correction.

2. Corrective action.

 

Preventive action is used to prevent a potential NC.

 

Regards,

 

Tony