Risk management in CAPA

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iso9001:2015 Risk

How to Include Risk Management into Your CAPA?

Even though the preventive action is no longer part of the terminology of the ISO 9001:2015 standard, A lot of people still use the phrase CAPA (corrective and preventive actions). CAPA’s have been around for quite a while and are a crucial part of the continuous improvement for a lot companies. With the new risk-based thinking coming in it can be good practice to make risk management part of the CAPA strategy.

Vanila CAPA

CAPA has been used a lot as a way to take action on incidents or issues that happened within a company. By deploying a strategy of corrective and preventive actions, the company tries to prevent these incidents from happening in the future.

The CAPA strategy allows companies to see what went wrong and forces them to think about proper actions on how to solve and prevent it. Because the output is an actionable list, every person involved in resolving the issues knows exactly what to do and when to do it. When all actions are taken the results are verified and checked for effectiveness. This way companies can clearly see the actual impact of the actions on the organization.

Risk Management Within CAPA

By adding the risk-based thinking into the CAPA, companies are allowed to keep their risk management up to date and lively. Whenever a CAPA strategy is created it is crucial to check the risks that are involved in that part of the organization. The very fact that something happened means that there is a risk in that particular part of the organization. Updating the risk management is important to keep the organization in line with the current situation. By incorporating the risk management, new actions are developed to reduce the risk for the company.

How to Do It?

Automation is there not only to help with the CAPA strategy, but also for the risk management strategy. Easily distributing the different corrective and preventive actions to the designated owners helps in tracking the progress of the strategy. Also the ability to directly connect to the different actions to the risks sets for much better traceability of the actions and their origin. This way the people in charge of quality and safety are more in control of the process.

If you want to know how Qooling can help you in managing your CAPA strategies, just drop us an email.

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