The corrective and preventive action (CAPA) process is one of the most important elements within a medtech company’s quality management system (QMS). The goal of the CAPA system is to identify, address, and prevent systemic issues that could compromise product safety, regulatory compliance, and the overall operations of the business.

Despite its importance, however, a lot of companies struggle to implement a CAPA management system that’s both effective and efficient. Year after year, deficiencies in the CAPA process are a leading cause of Form 483 observations during U.S. Food and Drug Administration (FDA) inspections.

So, in this article I want to outline the five key components of a strong CAPA system and look at some of the common challenges medtech companies face with CAPA—and how to overcome them.

What is a CAPA system?

A CAPA system is a structured process for identifying, investigating, and correcting or preventing quality issues within an organization. Medtech companies are required to have a documented CAPA system in place by both 21 CFR Part 820.100 and ISO 13485:2016 (Sections 8.5.2–3).

The basic steps in a CAPA system follow a logical sequence:
• Inquiry and assessment
• Pre-investigation preparation
• Investigation and root cause analysis (RCA)
• Implementation and documentation of the CAPA quality action plan
• Review and verification of effectiveness

5 key components of a CAPA system

Although the five stages may seem simple enough, they all must be carried out thoroughly. Otherwise, you run the risk of spending excess time and resources going through the motions of a CAPA process that doesn’t actually solve the fundamental issue.

Here’s a brief breakdown of each step in the CAPA management system and how to carry it out properly.

1. Inquiry and assessment

The CAPA process begins with identifying a potential quality issue. The issue can stem from various sources, including internal and external audits, nonconforming material reports (NCMRs), customer complaints, product returns, and validation activities.

Once an issue is detected, it must be properly documented in a CAPA request. This request should include a clear description of the issue, supporting evidence such as audit findings or test data, and an assessment of the potential effect on product quality and patient safety.

At this stage, a quality review board (QRB) or material review board (MRB) typically assesses the issue to determine whether it warrants a CAPA. Not every problem should trigger the CAPA process—only systemic issues that require a formal investigation.

2. Pre-investigation

Once a CAPA is approved, the next step is to prepare for the root cause investigation. This involves assigning a unique CAPA tracking number, defining the scope and objectives of the investigation, and assembling a cross-functional CAPA team.

The CAPA team could include representatives from product development, manufacturing, quality assurance, regulatory affairs, or any other relevant department, to ensure a comprehensive investigation. The team’s first responsibility is to determine whether any immediate actions, such as stopping production or issuing a product recall, are required before moving forward with a full investigation.

3. Investigation and root cause analysis (RCA)

The effectiveness of your CAPA system depends on your ability to conduct a thorough root cause analysis. If you can’t identify the true cause of an issue, then any corrective actions you take will be ineffective—and the problem will continue.

Some of the most commonly used RCA methodologies include the 5 Whys, which involves repeatedly asking “why” to trace a problem back to its origin; and the fishbone (Ishikawa) diagram, which visually maps potential causes across categories like method, material, machine, manpower, measurement, and environment. Other methods include fault tree analysis and Pareto analysis, which help pinpoint the most significant contributing factors.

Once the root cause is identified, you’ll need to clearly document it, along with all your supporting data. A poor RCA is one of the most common reasons for CAPA failures. So, take the time you need during this step to make sure you’ve gotten to the bottom of the issue.

4. Implementation and documentation of the CAPA quality action plan

Once you believe you’ve identified the root cause, the next step is to develop what’s known as your CAPA quality action plan. Depending on the problem you’re investigating, the plan could include corrective actions, which eliminate an issue, or preventive actions, which prevent a potential problem or nonconformance from occurring in the first place.

For example, corrective actions might include design changes, supplier requalification, equipment upgrades, or enhanced employee training. Preventive measures, on the other hand, might involve process optimization, statistical trend monitoring, or new risk-assessment protocols.

A well-documented CAPA quality action plan will include specific corrective and preventive actions based on the RCA; timelines; responsible personnel for each action item; verification methods to ensure effectiveness; and updates to SOPs, training programs, or manufacturing processes.

5. Review and verification

The final step in the CAPA system—and in some ways, the most important—is to verify the effectiveness of the actions you’ve taken. If the actions aren’t working, then something has gone wrong within your CAPA process.

Verification of effectiveness checks (VOEs) may involve a trend analysis to monitor whether you continue to have similar issues post-CAPA implementation. They may also include internal audits and follow-up inspections to ensure compliance with updated processes, or customer feedback analysis to track whether complaints related to the issue have decreased.

The MRB should formally review the CAPA, assess its effectiveness, and determine whether additional actions are needed. If a CAPA is found to be ineffective, you’ll need to reopen the process for further investigation and corrective actions.

3 challenges to implementing a CAPA system, and how to overcome them

The CAPA process has a logical, step-by-step flow that, in theory, should be easy to execute. So why do medtech companies struggle so much with CAPA? The answer can’t be boiled down to one problem that can be solved with a silver bullet. Different companies have different issues with CAPA. However, there are a few common problems that tend to crop up.

Poor root cause analysis

A lot of CAPA systems don’t work properly because companies focus on treating symptoms rather than identifying the actual root cause. This typically happens when teams don’t conduct a thorough analysis, rely on assumptions about the problem, or lack the expertise to pinpoint the underlying issue.

If you haven’t implemented a structured RCA method (like 5 Whys or the fishbone diagram), then you could be failing to get at the root cause of your problems. It’s best to choose a method, train your team in how to use it, and then follow that methodology closely—wherever it leads you. You might be surprised at how often the assumptions about what’s causing a problem don’t actually touch the underlying issues.

Overuse or underuse of CAPA systems

This might be deemed the “Goldilocks” problem with CAPA systems. Some companies initiate a CAPA for every minor issue, bogging themselves down in unnecessary documentation and endless investigations. Other teams consistently fail to trigger a CAPA for systemic issues, which can lead to product issues and regulatory violations.

The best companies find a middle ground—the “just right” CAPA frequency—that allows them to give attention to systemic issues without getting CAPA happy. To find that middle ground, it helps to establish clear guidelines on what qualifies as a CAPA-worthy event and what can be addressed through other quality processes. Making sure your team is regularly trained on these SOPs will go a long way toward making sure your company uses its CAPA system judiciously.

Lack of cross-functional collaboration

CAPAs often require input from multiple departments. Yet many organizations leave the process entirely in the hands of the quality team. And when CAPAs become “quality’s job,” they also quickly lose their effectiveness. A problem that touches multiple departments can’t be solved with a siloed approach.

Instead, medtech companies should form a cross-functional team when a CAPA requires it. That could include representatives from product development, manufacturing, regulatory, even marketing and sales. Having regular management reviews and establishing a collaborative culture where quality is everyone’s responsibility will truly help improve your CAPA system.

Published June 19, 2025, by Greenlight Guru.