CAPA risk management

One of the most commonly quoted, accepted definitions of risk is that it is the probability of harm or hazard in an event. From this definition, it is clear that nearly every clinical action comes with a risk attached to it. CAPA stands for Corrective and Preventive Action.

The CAPA-risk management connection

The risk an event carries in it is likely to cause physical damage to a product, into whose creation some risk is inbuilt. Risk could also result in damage to either the humans who are part of the process or to the environment. Thus, in a healthcare organization, the CAPA-risk management aspects are extremely important and are interwoven.

The effect of risk is never uniform or predictable. Its extent depends on the assessment its stakeholders make of it. To arrive at the quantum or gravity of the damage caused by a risk, CAPA is needed. This gives some idea of the CAPA-risk management connection.

CAPA-risk management is inseparable

As we saw, CAPA goes into a process to mitigate risk. Since CAPA is an effective method of identifying, correcting and preventing the risk in a process; clinicians have to keep a few important CAPA-risk management factors in mind:

  1. Is the nature of the hazard old or new?
  2. Has the severity changed since the process began or not?
  3. What is the frequency of the occurrence of the risk that is to be analyzed?
  4. How to identify the causes of risk.


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