Let’s Stop Confusing Everyone With CAPA!

I am really not a fan of the term “CAPA”. I think people’s eyes glaze over at the mention of it. It is seen as an administrative burden that the Quality Department and Regulators foist onto the people actually trying to do the real work. And I think it’s a mis-named term. CAPA stands for Corrective Action, Preventive Action. When there is a serious issue arising in a clinical trial, a CAPA is raised. This is meant to get beyond the immediate fire-fighting of the situation and to get to root cause so that corrective and/or preventive actions can be put in place. Sounds sensible. But what about when I ask you what the difference is between a corrective and a preventive action?

ISO9001:2008 defines them as:

Corrective Actions – “The organization shall take action to eliminate the causes of nonconformities in order to prevent recurrence.”

Preventive Actions – “The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence.”

Not very easy to get your head around in part because of the use of the word ‘prevent’ in both definitions. And if a Preventive Action is designed to prevent occurrence then that means the nonconformity (error) cannot have already occurred. And yet a CAPA is raised when a nonconformity (error) has occurred. So the PA part of CAPA seems wrong to me. The different definitions of Corrective and Preventive have caused no end of confusion as organisations implemented ISO9001. The good news is that in ISO9001:2015, there is a significant update in this area. When a significant issue (non-conformity) occurs you are expected to implement those immediate actions to contain the issue (termed Corrections) and also Corrective Actions to try to prevent recurrence. But the Preventive Actions are not associated with the issue. They now fit into an overall risk approach. By assessing risks in processes up-front and then continuously through their life-cycle, you are expected to develop ways to reduce the risk. These are the Preventive Actions or in risk language, the Mitigations.

Sound familiar? In clinical trials of course, we have the ICH addendum (ICH E6 R2) bringing in significant language on risk which brings it more in line with the revised ISO9001:2015 standard and is a welcome change. What is odd is that the addendum includes the following in 5.20.1:

If noncompliance that significantly affects or has the potential to significantly affect human subject protection or reliability of trial results is discovered, the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions.

This, unfortunately, mentions preventive actions next to corrective ones without any explanation of the difference and no link to the approach to risk in section 5.0. So it seems the confusion will remain in our area of work. And that confusion is compounded by our use of the CAPA terminology.

I would vote to get rid of the CAPA term all together and talk about CAR (Corrective Action Requests) and Risk. Maybe along with that, we could rehabilitate the whole approach. Done well with good root cause analysis and corrective actions, CARs are an important part of a learning organization. They should not be seen as some tedious administration that the Quality Department is requesting.

What do you think? Perhaps it’s all clear to you and you think CAPA is a great term?

In my next post I want to go back into the root cause analysis (RCA) process itself – whether DIGR^® or another method. I’ll talk more about the corrosive effect of blame on RCA and how to overcome it.

DIGR^® is a registered trademark of Dorricott MPI Ltd.

Picture: ccPixs.com

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