Corrective Action vs. Preventive Action in ISO 9001

Corrective action and preventive action (often referred to as CAPA) are essential components of quality management systems (QMS) under ISO 9001, aimed at improving processes by addressing recurring non-conformances and preventing potential issues.

Definition of Corrective and Preventive Actions

Organizations utilizing a QMS, especially based on ISO 9001, understand the importance of both corrective and preventive actions:

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

Corrective actions are reactive measures taken after a non-conformance has occurred, aiming to prevent its recurrence. On the other hand, preventive actions are proactive measures planned and implemented to address potential issues before they arise, thus preventing non-conformities.

Why Preventive Action Was Removed from ISO 9001:2015

In the latest revision of ISO 9001:2015, the concept of preventive action was removed. This change was not because preventive measures are less important, but to align with a more streamlined, risk-based approach. The new version emphasizes:

1. Risk-Based Thinking – Organizations are required to identify risks that could affect the QMS and decide if action is needed to mitigate them. This approach covers both risks and opportunities (“positive risks”).
2. Improvement – Continuous improvement of QMS processes serves as preventive action. The focus is on enhancing processes rather than following a separate, complex preventive action system.

Implementing Corrective and Preventive Actions

Here are steps typically involved in implementing corrective and preventive actions:

1. Identify the Process Problem – Clearly define the issue affecting the process.
2. Assess the Impact – Determine the extent and implications of the problem.
3. Contain the Problem – Take immediate measures to prevent the problem from worsening.
4. Identify Root Cause – Investigate to find the underlying cause of the problem.
5. Develop a Corrective Plan – Create a plan to address and eliminate the root cause, ensuring it doesn’t lead to further issues.
6. Implement the Plan – Execute the actions outlined in the corrective plan.
7. Verify Effectiveness – Conduct checks, tests, and reviews to confirm that the corrective actions were successful.

By following these steps, organizations can effectively manage corrective and preventive actions to maintain and improve their QMS processes under ISO 9001 standards.