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What Is CAPA in the Medical Device Industry?

by | Jan 28, 2022 | CAPA, Medical Devices

CAPA consists of a specific set of actions that an organization must complete to resolve and eliminate recurring non-conformance. CAPAs are commonly used when medical devices are non-conforming.

Let us say that your medical devices company is manufacturing lifesaving Class III medical devices, including cochlear implants, which is your most marketed product. Out of the blue, you start getting complaints that a new batch of cochlear implants is malfunctioning.

Your end-users and the regulatory agencies in the countries where you market these devices demand that the problem be meticulously investigated to ensure that it will not occur again.

Your company will immediately initiate a CAPA.

In this article, we will explain what CAPA is and how to implement a successful CAPA management system for organizations operating in the medical device industry.

But first, let’s cover some of the fundamentals:

What Is CAPA?

CAPA is the acronym for Corrective Action and Preventive Action (CAPA).

It is a system that all medical devices companies need to have in place to identify all quality-related issues, investigate the root cause, and implement corrective actions and preventive actions to ensure that such problems do not arise again.

Consider the malfunctioning cochlear implant. You will trigger a CAPA to ensure that the problem is both sorted out and will not arise again.

What Should Trigger CAPA?

We now know that CAPA is not a warning system, but rather a system that will address a quality issue.

It is typically triggered by one of the following systems.


A non-conformance results when there is something wrong with a product, service, or process.

For example, the result does not match your initial expectations. On inspection, you find that silicone to be used for ureteral stents is not of the required quality. This is a non-conformance that needs to be addressed.

When there are repeated non-conformances, you will also trigger a CAPA.

Recommended Reading: What Is Non-Conformance and How to Minimize It

Customer Complaints

When a product is released to the market, consumer complaints assist in identifying any problems.

For example, your product has been shipped to different markets. Now, you start getting complaints from your customers.

Let us say that the packaging material used for your medical devices is not top-notch, and customers from different markets have started complaining. It is not a one-off complaint, but a series of complaints that need to be looked into urgently.

This has greater repercussions for your company, so you will trigger a CAPA.

Recommended Reading: Medical Device Complaint Handling Processes

Internal and External Audits

The audits conducted by your company, either internal or external, are a crucial source for triggering CAPA.

For instance, internal audits conducted on a new batch of 5cc syringes have reported that the syringe volume is actually 5.2cc.

This is a major non-conformance that will trigger a CAPA.

The Importance of CAPA in the Medical Device Industry

As a medical devices company, you are mandated by regulations set by the US Food and Drug Administration (FDA) and International Organization for Standardization (ISO).

When a product fails for whatever reason, these regulatory bodies will mandate that you rigorously investigate the reasons under FDA 21 CFR Part 820 and ISO 13485. You will investigate and solve the issues concerning your medical device using corrective and preventive action (CAPA). The main purpose of CAPA is to ensure that the problem does not recur in your company.

As a medical devices company that has Class II and Class III products registered with the US Food and Drug Administration (FDA), you will be regularly inspected by them for compliance with 21 CFR Part 820.

After the inspection, you may receive an FDA 483, also called as ‘Inspectional Observations’ Form or a warning letter. The former (namely the FDA 483) will list all observations that the FDA representative made in your facility that is a likely cause for apprehension. Do note that you have a maximum of 15 days to respond to the FDA 483 in the form of a written response.

Your response to the FDA 483 and closure of the issues is crucial. Otherwise, you may be issued an FDA Warning Letter. Remember that warning letters are immediately made public by the FDA by being posted on their website.

In fact, the most common reasons for FDA 483 observations and warning letters are that procedures for corrective and preventive action have not been established or are not adequate in your medical devices company.

Other reasons for establishing CAPA are as follows.

Regulatory Compliance

As mentioned previously, CAPAs are part of the overall QMS and are mandated by international regulatory agencies, including FDA 21 CFR 820.100 and ISO 13485. If your company fails to adhere to CAPA, you will be violating international regulatory rules.


Not only is CAPA used for corrective action but also preventive action.

This means that any likely problems with a medical device will be sorted out increasing the efficiency of your company.

Product Quality

You ensure that a product’s non-conformance is resolved, and the product’s quality is as good as before.

If you look at the example of the malfunctioning cochlear implant, you would have resolved the problems and the product can once again be marketed.

Cost Savings

Let us say that a few customers have complained about their malfunctioning cochlear implant. You have taken these complaints seriously and recalled the necessary batches from the market.

In this way, you are not only proving your responsibility to your customers but also avoiding future messy and expensive litigations.

Corporate Branding

By complying with regulatory requirements, audits, customer complaints, etc., you effectively initiate CAPAs.

All these will help improve your brand value in the market.

Nowadays, companies are streamlining their CAPA processes by implementing efficient CAPA management software. If you are interested in facilitating your CAPA management activities, explore the SimplerQMS CAPA management software solution. It makes it easy for organizations to manage non-conformances, customer complaints, audit findings, and other quality issues, all in one place.

CAPA Regulatory Requirements

FDA 21 CFR 820.100

As per the US FDA’s requirements, CAPA comes under FDA 21 CFR 820.100.

It states in part that:

“(a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action.”

A wide range of requirements are listed for corrective and preventive actions (CAPAs), these include:

  • The need to investigate the causes of non-conformances
  • Identification of the actions that an organization needs for correcting and preventing recurrences
  • The need to verify and validate the effectiveness of the corrective actions taken and to ensure that there is no adverse effect on the completed product

ISO 13485:2016

ISO 13485:2016 standard for CAPA falls under section 8.5.2 for corrective action and section 8.5.3 for preventive action.

ISO 13485:2016 states that the organization will verify that the corrective actions taken do not adversely affect the organization’s ability to follow the necessary regulatory requirements or the safety and performance of the medical device.

5 Tips for Effective CAPA Management

The top 5 tips for effective CAPA management are mentioned below.

1. Create a Process

The most important aspect for creating a CAPA process is the CAPA procedure – which includes the inputs (such as complaints and audits), resources that review the CAPA request (either the Quality Manager or the Quality Review Board of your company), acceptance of the CAPA, and so on.

You should also remember that for an effective CAPA, a CAPA form must be initiated with all the details filled in.

Free CAPA From Template Download

2. Document All Non-conformities and Feedback

Another crucial aspect is that your company should document feedback as well as all non-conformities using a non-conformance report (also called NCR or non-conformity report).

This is crucial because over-estimating or under-estimating issues to CAPA are unproductive.

3. Use QMS Software

The use of an integrated QMS software solution like SimplerQMS that automates CAPA processes such as routing, notifications, follow-ups, and approvals will help accelerate the resolution of the particular CAPA issue faster.

4. Conduct a Thorough Investigation of the Root Cause

There can be more than one potential cause and determining which cause is more important can be a problem. You can identify the root cause of the problem using systematic analyses such as the 5 Whys and the Fishbone Diagram.

5. Keep Data Centralized

You should have a central point in your company wherein all CAPAs are documented.

This will help you:

  • Monitoring the efficacy of actions taken
  • Determine the start and closure dates
  • Identify inputs from relevant departments

All this is made possible by implementing QMS software.

Streamlining CAPA Management Processes

CAPA management is a critical part of quality management, but it can be tedious and time-consuming.

To this day, many small to medium organizations use manual, paper-based systems to manage their CAPA processes. This makes it hard to keep track of what actions have been taken, who is responsible for the action items, and when they will be completed. This leads to unnecessary delays in issue resolution which potentially puts your company out of compliance with regulatory bodies.

SimplerQMS provides QMS software with powerful CAPA management capabilities, designed for medical device manufacturers and other life science organizations. It allows you to automate routine processes, such as the creation of documents, routing, notifications, and others, improve collaboration between teams, reduce manual work, decrease human error and accelerate quality issue resolution.

All this helps you meet your regulatory obligations as well as promote continuous improvement across your organization.

If you need help automating and streamlining the traceability of your CAPA process, we suggest exploring the SimplerQMS CAPA management solution.

CAPA Management Software Process

Final Thoughts

CAPA is important for your medical devices company for international regulatory compliance, cost savings, efficiency, and branding, amongst other reasons.

Rather than continuing with paper-based systems that have many pitfalls, when you opt for efficient CAPA management software such as SimplerQMS, you will have digitized and automated solution, centralized cloud-based data storage, pre-approved CAPA forms, and procedures, all at the click of a mouse button.

If you are interested in learning more about our QMS software solution with robust CAPA management capabilities, we suggest booking a demo today and talking to our experts!

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