CAPA risk assessment

Corrective and Preventive Action (CAPA) is an integral part of a medical device organization’s Quality System. CAPA is one of the dreaded terms for a quality professional; yet, very few realize that putting a CAPA in place for each and every event is a liability. Rather, putting a CAPA for critical activities of the medical device’s manufacturing process is more commonsensical. This is where CAPA risk assessment gains importance.

What is CAPA risk assessment?

Doing CAPA on risk assessment is considered the most pragmatic approach to CAPA. Why is this so? As we just saw, doing a CAPA on every event is eventually going to turn out to be a waste of time. So, the trick is in doing CAPA on what may be called a “life threatening” event. In other words, something that poses capital risk to the organization’s bottom line could be taken up for mandatory and immediate CAPA.

This is why CAPA risk assessment is considered the best approach. By making this, organizations understand to identify the event that requires the most immediate and critical CAPA. When an organization can identify this, it has got a hang of the ways of dealing with CAPA. CAPA risk assessment is the most effective medium towards understanding this. The simple thumb rule for carrying out CAPA risk assessment is that the greater the risk of the event; the higher its need for having corrective action taken against it.

Risk to check effectiveness

It is common sense that if an action is not going to be effective; it need not be done. It is for assessing the effectiveness of a corrective action that CAPA risk assessment is done. How? It helps to identify if an event’s CAPA is within the risk limits of the organization’s compliance standards.



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43337 Livermore Common | Fremont| CA | USA | 94539


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