Where does the CAPA process fit into your quality management system?

Donna Foulis Date published: Sep 07, 23

CAPA (Corrective and Preventive Action) is one part of an effective quality management system. The two things should work together to compliment each other, rather than being two sets of processes to follow. Read on to find out what CAPA is, how it forms a part of your QMS and the seven steps of the CAPA process.

What is CAPA?

CAPA stands for Corrective and Preventive Action. It’s a series of procedures to follow when problems arise, how to fix them and to prevent the same thing from happening again. There are two sides to CAPA – one is about reacting to an issue as it arises and being able to rectify it correctly. The other is about analyzing risk and putting steps in place to make sure potential incidents or non-conformances, don’t occur in the first place.

It doesn’t have to be a linear process. Ideally, you’d want to be proactively planning to minimize the chance of unwanted events from happening by mapping out the potential risks and putting controls in place (which would be your preventive actions). This would prevent the need for corrective actions having to be applied in the moment, or at least reduce the frequency of them. Think of it as a continuous cycle, both parts informing each other on a journey to continuous improvement.

Where does CAPA fit into a quality management system?

An effective quality management system holds together all the essential processes for meeting regulatory requirements, producing high quality products or services and ensuring everything is smooth and consistent throughout an organization. CAPA is one of the processes held within a quality management system. Think of the QMS as the framework, holding the plans and procedures and CAPA as the toolkit to carry these out.

To break it down even further, let’s use the process of baking bread as an example. The recipe lists all the ingredients and the instructions for the desired result, which is a delicious loaf of freshly baked bread. It’s a tried and tested method, with precise amounts of each ingredient, how and when to combine them and how long to bake the finished dough for. The baker is the person carrying out the actions.

On the first attempt, they might realize the mixture needs a little more water than specified. Or they notice that an additional instruction needs to be added about placing the bread in a specific part of the oven to prevent overcooking the top of the loaf. Here the baker performs a corrective action by adding more water. They also take a preventive action by adjusting the instructions in the recipe to prevent the risk of burning or overdoing the crust of the bread, ensuring a consistent result each time.

What are the seven steps in the CAPA process?

1. Identify current or possible issues

A problem might be brought to your attention as a customer complaint, equipment fault or a finding from an audit. Or it could be highlighted as a potential risk that needs attention before it has the chance to evolve into a non-conformance.

2. Evaluate the risk

Once the issue has been identified, the next stage is to determine the level of risk it might bring and what the impact of it is likely to be. This would take into account how serious it is and the level of resource required to address it, and whether it needs immediate attention or not.

3. Plan how to investigate

This involves creating a procedure for investigating the issue. It should cover every necessary detail including aims and objectives, timescales, resources and the assigning of tasks to the relevant personnel.

4. Analyze the information you have

Collating all the relevant documents and data in relation to the problem from your QMS provides the context needed to identify the root cause of the issue. You may also want to add any additional or new information at this stage.

5. Make an informed action plan

These are the changes that need to be put in place to correct, or prevent, the issue. This could be a revision to policy or procedure, an update to key documentation or a revision of day-to-day processes.

6. Implement the actions

Now the planned actions should be carried out and documented accordingly. Record keeping is key here to evidence within the QMS that appropriate actions have been taken, and to ensure that the incident doesn’t reoccur.

7. Evaluate the results

This final stage involves checking that all the actions have been carried out correctly, and evaluating how effective they were. This might then determine what controls to put in place, and if there is anything that could be done differently.

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