CAPA 101: An Introduction to Corrective and Preventive Actions

capa-corrective-preventive-actionCorrective and Preventive Actions (CAPA in short) refers to an approach to improving your company’s processes by reducing the risks of undesirable events and non-conformities. As a vehicle of risk-based thinking, it’s a vital part of any Quality Management System, and is especially crucial in regulated product innovation.

CAPA is a general method applied in various business contexts: HR, accounting, manufacturing, etc can all benefit from this systemic approach to adverse events and process improvement.

However, CAPA is more than just a general-purpose tool: it’s also a mandatory process in the development of products for regulated markets. In industries like automotive, aerospace, or medical device development, various standards and regulations require the use and thorough documentation of a Corrective Action, Preventive Action approach as an area of risk management & quality assurance. It’s considered a standard practice in Good Manufacturing Practice (GMP), as well as certain ISO and FDA regulations. Before we go into the details, though, let’s cover the basics!

What is CAPA?

In short, CAPA is a systemic strategy to reducing risks and improving processes. Corrective Action, Preventive Action provides a structured approach to identifying (potential) problems and their root causes, devising solutions for those problems, and documenting the solution so that similar issues don’t arise in the future.

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Risk Management with codeBeamer ALM

It has been referred to as the “immune system” of an organization – indeed, it does help you get out of trouble, and stay out of trouble. CAPA is a great tool to help identify the sources of actual or potential issues, and manage these opportunities for improvement.

CAPA is an all-encompassing tool that may (and should) be applied to software development, product manufacturing, documentation, procedures, and systems, ensuring that undesirable situations don’t arise, or arise less frequently in all these domains.

Using Corrective Actions, Preventive Actions for improvement

In short, a general CAPA process follows the well-known Plan-Do-Check-Act (PDCA) cycle.

First, you’ll identify non-conformities in your processes, and determine what kind of problem you’re looking at. Non-conformities may be identified during a systematic evaluation of processes (internal or external audits), as a result of customer complaints, or they may be reported internally.

If the issue at hand is not systemic, just a non-conformity that is likely to happen, you’ll use a Preventive Action to reduce the risks of this adverse event occurring. If your issue is systemic, your processes will need to be amended – a Corrective Action is needed to prevent the recurrence of the problem.

In other words, doing the CA of CAPA means you’re reactive, while applying the PA part will result in your organization being proactive, which is at the core of the risk-based thinking that some regulations require.

There are several techniques you can use to enhance your Corrective Actions, Preventive Actions approach. Root Cause Analysis is a deductive safety engineering method that helps identify and fix the sources of potential (or existing) problems. FMEA (Failure Mode and Effects Analysis) is another useful element of a proactive approach, providing input for your CAPA activities. Advanced Product Quality Planning, or APQP, is mainly used in the automotive industry to drive quality improvement in mobility end products. The 5 Whys-technique may also be helpful in uncovering the cause-and-effect relationships causing a particular problem.

Related reading:

Using Root Cause Analysis to Drive Process Improvement

The sound way to do Corrective & Preventive Actions is to then measure the efficiency of your actions, making sure that your implemented solution actually works as intended.

Corrective Actions, Preventive Actions in QMS regulations

While it’s beneficial for all kinds of organizations, CAPA is most important for companies operating in regulated markets such as the innovation of medical technology. As a key element of the Quality Management System, multiple global standards call for its use in the development of medical devices:

  • In the US, the 21 Code of Federal Regulation’s Part 820, section 820.100 stipulates that “Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action.”.
  • For EU product developers, the ISO 13485 QMS standard’s sections 8.5.2 and 8.5.3 are applicable: “The organization shall identify and implement any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.”

Innovative medical technology companies rely on advanced software tools to comply with the requirements of these regulations around applying and documenting CAPA. Intland's templates for medical device development offer built-in functionality to support the management of Corrective and Preventive Actions. Browse our site to learn more about these capabilities, or just get in touch with us for more information!

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Medical Audit & CAPA Template Download PDF

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