What is Corrective and Preventive Action (CAPA)?

The FDA, the US federal agency, lists Corrective and Preventive Action (CAPA) as one of the most crucial quality systems. The purpose of implementing CAPA is to identify, analyze, and control hazards, defect and nonconformities in order to ensure quality finished products. 

Before we go into the details, though, let’s cover the basics!

What is Corrective and Preventive Action (CAPA)?

Corrective and Preventive action is a quality management strategy that prevents known issues, such as nonconformities, from happening. This quality management strategy is used to identify and resolve systemic defects, prevent persistent problems from happening again, and allows for continual improvement.

Why are Corrective and Preventive Action (CAPA) Important?

Corrective and preventive action (CAPA) is an important tool for organizations to prevent potential risks and protect their employees. It helps organizations identify, investigate, and correct problems before they become major threats. 

It is especially important In industries like automotive, aerospace or construction because various standards and laws mandate the use of Corrective Action and Preventive Action (CAPA) for them to ensure quality assurance and risk management. 

But, in order for corrective and preventive action to be effective, several factors need to be considered. Some of them are: 

  • First, corrective and preventive action needs to be well organized and communicated throughout the organization. 
  • Second, it is important to have a clear understanding of the risks involved with each type of problem. 
  • Third, CAPA needs to be conducted based on accurate information.

Finally, effective CAPA requires ongoing monitoring and evaluation.

Difference Between Corrective and Preventive Action

The goal of preventive action is to prevent nonconformance by eliminating the root cause while the goal of corrective action is to stop nonconformance from recurring by addressing the immediate cause. 

Preventive and Corrective Actions (CAPA) are both important in any quality management software system as they aim to improve quality and prevent issues from occurring or recurring. However, preventive action is more effective at preventing potential issues while corrective action is better at addressing current issues.

Corrective Action for Non-Conformance

Corrective action is a process of identifying, analyzing, and taking corrective actions to eliminate defective products or processes. A non-conformance can be detected by using the defect management system (DMS) to detect it, record the defective products or processes, and report on the non-conformity with proper documentation. This can also assist you in choosing between different corrective actions by introducing them as a choice that depends upon how severe the issue is.

Preventive Action in The Workplace

Preventive action can be an effective tool in the workplace. This includes both construction sites as well as offices. Construction sites are dangerous places with many risks and hazards. However, there are ways to cut down on the chances of an occurrence occurring, such as a toolbox talk.

A preventive action tool that can be shared with each member of a group, this construction toolbox talks form is divided into sections that help gather detailed information on construction hazards and risk factors. 

A toolbox talk discussion is a collaborative discussion and can be used by managers to gather information from the team. Includes safety discussion and attendance records.

Examples of Corrective and Preventive Action (CAPA) Reporting

A CAPA report is used when the situation calls for both correcting and preventing problems. It is used for major non-conformance as recommended by the FDA. There are certain failures such as not conducting corrective action or doing it poorly, which are considered major non-conformances.

Creating a CAPA report is a process that ensures the facilities meet their various regulatory standards and remain compliant with industry standards such as ISO 9001:2015. The report gathers information about identified deficiencies and the response to them, along with the CAPA plan.

Axonator for Enforcing Preventive and Corrective Action (CAPA)

Businesses must always be on the lookout for quality and safety issues, but incorporating corrective and preventive actions (CAPA) can help to prevent the recurrence and occurrence of such issues. 

With a digital CAPA tool such as Axonator, you can optimize your processes to make documentation more efficient and eliminate paperwork. Doing so will improve the quality of your products and the safety of your workers, ensuring that all aspects of your business are running smoothly. 

Other features of CAPA include:

  • Corrective and preventive action (CAPA) form templates are free to use and customizable for a variety of industries.
  • Assigning specific workers to each form can help team members complete the forms more quickly.
  • By uploading media files, corrective and preventive action form templates can help make the problem or situation more visible.
  • Data analytics can help managers easily check for recurring failed items and actions.
  • Make it easy to check for recurring failed items and actions so that corrective action can be taken quickly and efficiently.

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