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What is CAPA? A Comprehensive Guide to Corrective and Preventive Actions

Experts estimate that bugs in software cost the US economy upwards of 60 billion dollars every year. This is often a preventable issue, but do you know how to best go about ensuring that your process is safe from such issues?

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This article will discuss CAPA, or Corrective and Preventive Action. This is a simple process by which you can make sure your software development process is free from preventable problems. For example, but not limited to, software bugs.

By the end, you should be able to discuss CAPA with the stakeholders and employees in your place of work. You can then put the process, or a process like it, in place to ensure the safety and high quality of your products!

What Is Corrective and Preventive Action (CAPA)?

CAPA is a method by which you can look for problems in the workplace and solve them so that others do not fall foul of issues. It aims to find issues, discover the root causes of those problems, then take action to prevent them from recurring in the future.

Related reading:

CAPA 101: An Introduction to Corrective and Preventive Actions

CAPA aims to educate a group of developers to ensure they see and understand problems before they happen. This way, they can take proactive action to ensure the software development process runs well and is safe from future issues.

Also, it is not only a process that you should involve during programming or when problems with software occur. You can use it during every step of a product flow.

Issues may occur during the design, programming, testing, or quality assurance, steps. These can all make use of CAPA to improve and prevent issues from recurring. But we will focus on software programming for now.

Related reading: 

Improving Your Software Quality Assurance Process in 2021? Start here.

CAPA: The Basics

Corrective and Preventative Action can split into two distinct steps:

Corrective Actions: First of all, after finding a problem or bug in your work, you should take action to discover why it occurred. This will usually occur in the form of Root Cause Analysis, or a technique called "The Five Whys". You should find the core problem in the flow of your product through its steps to creation.

After you find this problem, you should work to fix the problem as it currently exists. This stops it from happening in the here and now, preventing further losses in the short term. This does not fix the long-term issue, though, which is why Preventive Action needs to occur.

Preventive Actions: After resolving the action, you should start to look for any lessons that you and all affected parties can learn from the issue. You should aim to make changes in your development process and company to prevent the issue from occurring again. This may involve changes anywhere in:

Awareness: With training in how to recognize similar problems in the future

Communication: With people needing to speak about specific issues earlier

Process: Such as moving around the order you perform actions in or how you perform them. This can include changes to how you program, or how you commit work.

Oversight: As it may be that someone needs to watch over the tasks as they occur in the future to remove barriers. This can include pair programming or checking others' work before committing it to the build.

Human resources: With the problem being the attitude of an individual or group in the company

Why Should You Implement CAPA?

Many times, teams find issues in a process and deal with them then and there. However, that doesn't stop the same problem from surfacing (and causing issues) again.

You can compare this to a medical condition. If someone has a damaged lung, but the doctor only treats a resulting cough, the cough may recur. Or, the lung issue could get worse, causing more harm to the patient. Only by treating the underlying condition can you prevent further health issues resulting from the problem.

We can extend this metaphor to a software development process or a working environment, where CAPA is also used. Therefore, you need to be aware of the underlying issues that cause problems in your application. If you do not, the problems will keep cropping up.

Pushing for Corrective Action

When working with your team, you may spot a problem and try to resolve it. You should attempt any or all the following steps to make sure you resolve it correctly:

  1. Informing the team and wider set of developers of the issue, so that this specific problem is well documented
  2. Agree on a problem statement so that everyone is on the same page about what the issue is
  3. Discuss the major causes of the issue
  4. Work along with others in the team on each of these causes to discover a root cause behind the problem
  5. Continue to ask "Why?" about each major cause, until you develop a series of answers that feed into and contribute to resolving the underlying issue

These issues may relate to many areas of the company. After finding the root causes, work to solve them one by one until the problem gets fixed in the short term.

Pushing for Preventive Action

After you have solved the issues in the application, you should be trying to prevent similar issues from happening in the future. Preventive action is not always related to the specific issue that happened, but others that may crop up moving forward.

Preventive action tends to be systemic and process-related, rather than focusing on specific code, hardware, or employees.

It also encourages members of your team to change their actions so that they are more aware in the future. They should remain conscious of the possibility of such issues occurring so they can fix them before they become a problem.

Once any preventive action has occurred, you'll need to make sure is both documented and enacted. A specific role or group could even have the responsibility of handling the problem in the future, removing or reducing the chance of similar issues occurring again.

What Next?

You should now have a much stronger understanding of what CAPA can do for you and your product development environment. To help put it into practice, we've developed Medical Audit & CAPA Template for life sciences product innovators. Download our template brochure, or send us your questions!

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