corrective and preventive action, capa

Corrective and Preventive Actions (CAPA) are quality management processes that help organizations deliver a high-quality and error-free product.

Today’s post will provide details of these two quality management processes, with examples, templates, and an action plan.

Corrective Action

Corrective actions remove the cause of nonconformity from a product. It is a reactive process. Here, an error has occurred, and this process ensures that the error will not occur again.

According to ISO 9001, “The organization shall take action to eliminate the causes of nonconformities in order to prevent a recurrence.”

Preventive Action

Preventive actions help stop nonconformity from a product or process before it occurs. It is based on experience or lessons learned. Preventive action is a proactive process that ensures that the product and processes are error-free.

According to ISO 9001, “The organization shall determine an action to eliminate the causes of potential nonconformities in order to prevent their occurrence.”

Examples of Corrective and Preventive Action (CAPA)

You have identified a dimensional error in your deliverable. You replace the deliverable and change the equipment settings so the deliverable is of the exact dimension and the error does not occur again.

This is an example of corrective action. The error has occurred, and you took measures to ensure that this error does not happen again.

Now we come to an example of preventive action.

You are going to start a process in a new organization. In the past, you have identified an error in similar equipment and are afraid it may happen with the current equipment. So, you check the settings and ensure that the error will not occur with the product.

This is an example of preventive action because the error has not yet occurred, but you took measures to stop it from occurring. 

Corrective Action Vs Preventive Action

The following table shows the difference between corrective and preventive action.

S. No.Corrective ActionPreventive Action
1Error has occurredError has not yet occurred
2Reactive processProactive process
3Example: Process updateExample: Process review

Corrective Action Vs Correction

Correction is another quality term that is also known as defect repair. In correction, nonconformity has occurred in deliverables, and you have to either correct the deliverable or replace it.

If the nonconformity is repairable and the repair cost is less than the deliverable cost, you will repair it; otherwise, you will replace the deliverable.

Also, if the deliverable is not repairable, you will replace it regardless of the cost.

Corrective and Preventive Action Plan

According to ISO 9001, implementing CAPA requires seven steps. 

  1. Define the Problem: Identify the problem, such as whether it is a process issue or a problem with a specific deliverable. The problem should be real, not a perceived one. 
  2. Define the Scope: Understand the context, the issue, analyze the problem, find its root cause and its impact on other processes.
  3. Containment Actions: Take immediate measures to stop it from occurring and then develop a thorough plan to contain the error and stop the issue permanently.
  4. Identify the Root Cause: You must identify the root cause of the problem. You can use a fishbone diagram, five whys, etc.
  5. Plan the Action: Develop a realistic plan that has realistic deadlines and solves the root cause of the issue. If the issue is big and requires a large investment, you may consider a cost-benefit analysis.
  6. Take Action: Take action and implement the plan to contain the nonconformity.
  7. Follow-up and Ensure the Plan Worked: Review the plan and see if it was successful.

CAPA Template

corrective and preventive action capa template

Summary

Corrective and preventive actions require the same activities; however, the trigger is different in both cases. In corrective action, a nonconformity has occurred, and measures have to be taken to correct the process to stop it from happening again. On the other hand, preventive action is a response to an anticipated error that hasn’t occurred, but measures are taken so it will not occur.