CAPA and risk management

Risk has been often described as the probability of harm or hazard in an event. So, it is to be understood that in the healthcare industry, almost every clinical action has a risk inherent or attendant in it. CAPA, on the other hand, is about corrective and preventive action. From these definitions, we can draw a link between CAPA and risk management.

How are CAPA and risk management related to each other?

Risk can mean physical damage to a product arising out of a process that is necessary to perform. It could also mean damage caused to the humans involved in the process or to the environment. Assessing the risk factors is thus of paramount importance to a healthcare organization that is involved in some or another process.

An important element of risk is that its gravity on any single action is subjective. That is, different stakeholders place differing meanings and values for the risk levels in an action or outcome. It is to evaluate the extent of the damage caused by this risk that CAPA is evoked. Thus, CAPA and risk management share a cause-action relationship.

Why are CAPA and risk management built into each other?

CAPA is built into a process because it has to mitigate risk. It is one of the effective methods of identifying, correcting and preventing the risk got from a process. A few challenges have to be anticipated and overcome while implementing CAPA into the risk process.

  1. When to open a CAPA has to be identified clearly. This is difficult, because the effect and outcomes of processes keep changing over time;
  2. This is all the more difficult in combination products, because their process and result keep fluctuating through the process;
  3. When new procedures are introduced midway into the process, CAPA and risk management take a new form.

Factors to consider for CAPA and risk management

In implementing CAPA and risk management, clinicians have to keep a few important factors in mind:

  1. The nature of the hazard –whether old or new;
  2. What is the level of severity –has it changed since the process began or has it remained the same?
  3. The frequency of the occurrence of the risk has to be analyzed;
  4. It is necessary to identify the causes of risk;

This illustration provides some idea of how CAPA and risk management need to be built into each other:





Contact Detail
43337 Livermore Common | Fremont| CA | USA | 94539

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s