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Etienne Nichols

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Five Foundational Steps of a CAPA Quality Process

A well-defined CAPA program is a framework for quality and effectiveness

Published: Monday, April 10, 2023 - 00:02

I have a bold opinion: The corrective and preventive action (CAPA) process is the second-most important component of your quality management system (QMS). (If you want to know what I think is No. 1, shoot me an email.) As you build medical devices, a well-defined CAPA program provides a framework for quality and effectiveness, whether in product, process, or people. That’s why getting the CAPA quality fundamentals right is so important.

Let’s take a look at the five foundational steps of the CAPA quality process.

1. Identify potential CAPA quality cases
CAPA is the heart of your QMS and indicates its overall health. So, monitoring the inputs to the CAPA process is essential to ensure you’re promptly identifying any potential quality issues. The U.S. Food and Drug Administration (FDA) agrees because 21 CFR 820 includes a requirement for manufacturers to have processes to analyze input data.

There are quite a few CAPA inputs that you should be actively monitoring, such as:
• Nonconforming material report (NCMR)
• Internal and external audits
• Management reviews
• Validation activities
• Risk analysis
• Complaints
• Clinicals

When you’ve spotted a potential CAPA case, the next step is to document it with a CAPA request. These should contain an accurate description of the possible CAPA, a detailed list of its probable sources, any available evidence, and an explanation of how the information was reported.

From there, a quality review board (QRB)—a group consisting of strong cross-functional representation—should review to determine whether a CAPA investigation should or shouldn’t take place.

It’s crucial that you understand what should or shouldn’t trigger a CAPA investigation. Your CAPA process is meant to address systemic quality issues, such as a component that repeatedly fails inspections during manufacturing.

Occasionally, companies get “CAPA-happy” and escalate every one-off event into a CAPA. It may seem like a good way to be diligent, but this approach is reactive and ultimately weakens your CAPA program’s effectiveness.

2. Prepare for investigation with a defined CAPA quality process
As the saying goes, “Those who fail to prepare should prepare to fail,” and while I risk sounding like your high school vice principal, this is abundantly true in your CAPA program. Once you’ve accepted a case into your CAPA program, the next foundational step is to make sure you are fully ready for the investigation.

It’s always a good idea to formalize the process by assigning  a unique identification number to the new investigation. This will help you to track and reference the case throughout the CAPA process.

You’ll also need to finalize your CAPA sources by identifying the parties, processes, procedures, and departments that may be associated with the CAPA. It’s important to be thorough, because any missing information will negatively affect your investigation as the process moves forward.

In terms of your CAPA sources, keep in mind that there are six potential sources for a quality problem:
• Method
• Material
• Machine
• Manpower
• Measurement
• Mother Nature (aka environment)

Once you’ve clearly determined the sources, products, and processes involved with the CAPA, this will help you to identify the people you need on the team overseeing the investigation. I advise you to carefully consider who should be involved.

For example, you might need engineering, marketing, manufacturing, or regulatory people as part of your team. Whatever the case may be, build your CAPA team appropriately for addressing the issues identified.

3. Investigate the root cause of a CAPA quality problem
With your data, sources, and team in place, it’s time to get down to business. Start your investigation by determining what immediate actions are needed for containment. This might mean stopping production, switching to a new parts supplier, or issuing a recall—whatever is needed to prevent the issue from becoming more widespread.

Once the issue has been contained, you can turn your attention to the root cause of the problem. To do so, your investigation should return to the source—the product, processes, and people involved.

When issues arise with a medical device, a root cause analysis offers an opportunity to gain understanding that will help with the current problem and provide insight moving forward.

In addition, 21 CFR 820.100 states that manufacturers must have established procedures for implementing CAPA, and these procedures must include “investigating the cause of nonconformities relating to product, processes, and the quality system.” Root cause analysis fills this role.

There are numerous methods for root cause analysis, such as:
• 5 Whys is a process of asking successive questions based on the answer to the previous question.
• Fishbone diagrams are a visual way to sort potential causes into categories branching off from the original problem.
• Flowcharts are a method of mapping the process through the different pathways in the organization to identify potential sources of the issue.
• Pareto charts are graphs used to visualize the most likely sources of an issue.
• Scatter diagrams are a comparative way to plot pairs of data points to determine correlation.

4. Implement and document the CAPA quality action plan
Once the root cause analysis is complete, the results should directly inform your decisions on the actions needed to keep this issue from becoming a recurring or systemic problem.

This is typically called a CAPA quality action plan, and it should contain the specific steps, SOPs, roles, reporting requirements, and expectations as you implement your corrective and preventive actions.

There are three kinds of problem-solving actions typically used:
1. Corrections refer to actions taken to immediately address a problem or nonconformance. They are focused on fixing a current issue and don’t necessarily prevent the problem from occurring again.
2. Corrective actions, on the other hand, are longer-term solutions that are implemented to address the root cause of a problem and prevent it from occurring again.
3. Preventive actions, also known as preventive measures, are proactive steps that are taken to prevent problems or nonconformances from occurring in the first place.

In addition to the type of action, CAPA quality action plans should include:
• Due date
• Action description
• Responsible person
• Plan for effectiveness check
• Verification of effectiveness checks (VOE)

5. Verify CAPA quality effectiveness with a management review
With the corrective and preventive actions implemented, you may be feeling excited to wrap things up, close the case, and move on with your life. However, the final foundational step of CAPA is perhaps the most important because it determines whether your CAPA quality program is functioning properly at all.

In this step, the CAPA goes back to the cross-functional team and the material or quality review board (QRB) to assess whether it has been satisfactorily completed. More specifically, they should be checking to see if:
• CAPA resolved nonconformances
• Preventive actions have been effective
• CAPA actions have caused any new problems

Companies sometimes struggle with effectiveness checks, particularly in choosing the right method of verification. It can get quite tough when QRBs have to quantitatively measure aspects of a CAPA investigation because these require a great deal of data collection, sometimes over a long period of time.

Thankfully, there are some tried-and-true methods for verifying effectiveness of your CAPA quality issue:
• Trend analysis, in which you review data over a specific period of time to determine if the problem occurs again
• Periodic checks, in which you schedule time for the quality board to review that a process has been corrected
• Surprise audits, in which you audit with no announcement to confirm whether the procedures and actions are being followed by your team
• Sampling, in which you verify corrective actions by using a subgroup of data as a representation of the whole dataset

Choose a quality management solution built with a dedicated CAPA workflow for your medical device.

Even with a well-defined CAPA quality process and procedures, running an investigation can sometimes feel like a heavy weight on your shoulders. But you can effectively manage your risk-based CAPA process in a connected ecosystem where inputs and outputs tell the true story. Contact Greenlight Guru for a free personalized demo.

First published April 2, 2023, on the Greenlight Guru blog.


About The Author

Etienne Nichols’s picture

Etienne Nichols

Etienne Nichols is a medical device guru and mechanical engineer who loves learning and teaching how systems work together. With a Project Management Professional (PMP) certification, Nichols is experienced in manufacturing and product development aiding in the development of combination drug-delivery devices.




I see where you love "teaching how systems work together". So on that and "CAPA", they are defined differently and have different 'steps' therefore it should be CA and PA as in Management Systems and Industry standards. Yes they do and should "work together" but are not together.