Corrective Action Preventive Action (CAPA)

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You may have seen it stated as “Corrective and Preventive Action” or as “Corrective Action Preventive Action”. Either way, the definition of CAPA is the same. CAPA is a process of identifying non-conformities or undesirable situations and creating a plan of action to eliminate the causes. While the term puts corrective action first, preventive action should be your priority. This is because corrective action is reactive, and preventive is proactive. This is the same as with maintenance, where you want to perform primarily preventive maintenance to avoid equipment breakdown.

Corrective Action vs. Preventive Action

The ultimate goal of CAPA is to do everything you can to ensure the problem will not happen again. When an unexpected issue or non-conformity occurs, you perform a root cause analysis (RCA). This allows you to determine what corrective action you need to take. The easiest way to define corrective action is that it solves an existing problem. On the other hand, preventive action eliminates the cause of potential problems. It is a common misconception that these two processes are connected, but they are not. Ideally, your preventive action works to prevent the need to ever take corrective action. Some examples of preventive action include creating checklists, implementing preventive maintenance plans, or establishing safety policies.

Corrections vs. Corrective Action

It is essential to understand what corrective action is. In fact, there is a difference between “corrections” and corrective action. When you correct, temporarily repair, or contain, that is a correction but not corrective action. For example, a piece of equipment is low on oil, so you add more. Adding more oil is a correction, but it does not solve the root cause. Therefore, it is not a corrective action. Next, you would have to perform a root cause analysis to find where the oil leak is. Once you identify the leak and repair it, you have completed corrective action. To take that corrective action a level higher, you could create a preventive maintenance plan to inspect your repair to ensure the leak doesn’t happen again.

Who Can Benefit?

Several industries are required by law to have an established CAPA process as part of their quality management system. The U.S. Food and Drug Administration (FDA) requires it for medical devices and the pharmaceutical industry. Furthermore, it is a standard for Good Manufacturing Practice (GMP), Hazard Analysis and Critical Control Points (HACCP), Hazard Analysis and Risk-based Preventive Controls (HARPC), and various International Organization for Standardization (ISO) business standards. However, if CAPA is not required for your business, it is still a useful problem-solving approach for many businesses. When you experience a problem in your business or with a product, it is typically a symptom of an underlying issue.

You can use CAPA for:

  • Product Design
  • Manufacturing
  • Food Processing
  • Packaging, Shipping, Distribution, and Transport
  • Testing Verification

How to Implement Corrective Action Preventive Action

There are four main steps to implementation:

  1. Collect and analyze data to identify existing problems or non-conformities, as well as potential ones.
  2. Perform root cause analysis to create your corrective or preventive action plan.
  3. Implement your plan for corrective action or preventive action.
  4. Inspect regularly to ensure that your actions are still effective.

This is not a process that you do once and never have to handle again. It is an ongoing practice that will grow and evolve with your business. As you expand or add new assets or service offerings, you will need to think of any potential problems to establish preventive action for. Finally, you must always have a system for checking on past corrective and preventive actions.

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