What is a Corrective Action?

Corrective Action Definition

A corrective action is a particular action aimed at removing the cause of product failures and nonconformities in an effort to prevent their future recurrence.

What is a Corrective Action


What is difference between preventive action and corrective action?

Corrective actions are a set of actions taken to rectify, or change a process that causes errors or nonconforming issues or events. Preventive actions are proactive measures that are taken to prevent nonconformities from occurring in the future.

*Source: differencebetween.net

What are the steps of corrective action?

Corrective actions involves the following steps:

  1. Define the problem.
  2. Identify a short-term fix to resolve the problem until a more long-term solution is implemented.
  3. Determine the root cause of the problem. Fishbone diagrams, the “5 whys,” and 8D methodology are examples of tools commonly used for root cause analysis.
  4. Plan a measurable and achievable solution that focuses on the root cause. Set realistic deadlines for implementing the solution.
  5. Implement the corrective action and notify key stakeholders of the necessary tasks.
  6. Conduct analysis to verify the effectiveness of the corrective action.

*Source: integrify.com

What is a corrective action example?

Example of a problem requiring corrective action: Increases in product returns from customers and customer complaints due to defects.

Corrective action example: Implement additional manual inspection points and validation steps to detect errors prior to shipping the finished product to customers.

What is a corrective action at work?

An example of a corrective action at work would be the introduction of new safety policies and protocols and the retraining of employees to help reduce workplace injuries.

*Source: i-sight.com

5 Essential
Elements of a CAPA

Medical device companies must have a compliant Corrective Action Preventive Action (CAPA) process in place to comply with FDA 21 CFR 820.100.

Your CAPA processes will be managed by the CAPA subsystem of your quality management system. Learn the essential elements of a CAPA system.