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Jon Speer


Five Common Mistakes Companies Make With CAPA

Avoid jeopardizing the health of your QMS

Published: Wednesday, June 20, 2018 - 11:03

We raise the corrective and preventive action (CAPA) topic often because it is still something that companies tend to struggle with and find themselves in hot water over, particularly when it comes to regulatory audits or inspections.

There’s often a sense that CAPA is another inconvenient process that takes resources away from those preferred revenue-generating tasks, but in reality, failing to give CAPA appropriate focus can cost a company greatly. Could your company be making any of the common mistakes that tend to happen?

We’re looking at five issues here:

1. CAPA metrics

This can be summarized as the way we measure the effectiveness and productivity of our CAPA activities. A big mistake (and one which I’ve been guilty of myself) is in how metrics are established, and which ones are given focus to assess the “health” of CAPA in the company. A common one is “time to close a CAPA.”

Many companies will take this idea of time to close a CAPA and attach a number, for example “all CAPA must be closed within 90 days.” Is this right? Any kind of time limit is a difficult thing to know and understand at the beginning of any CAPA investigation. Your aim is to get to the root cause of the issue, but how does putting a time limit on that help?

A CAPA can be a complex investigation, and you need to get to the point of determining root causes and an action plan. Here’s when you can attach a due date to the CAPA:
• You’ve already identified the root cause
• You’ve created a list of tasks that must be completed to address the situation

You need to understand scope and magnitude before attaching a date. A better metric should be “time taken to establish a root cause.” Be deliberate about root cause determination because that is a methodical approach with a finite set of actions to take. A better key performance indicator (KPI) might be “percentage of CAPA where root cause was identified within X days.”

Another KPI for CAPA might be establishing a timeline once you’ve established root cause and key actions. A due date will make much more sense at this point because you have a clear understanding of what is required.

2. Lingering CAPA

You know that CAPA that has been open for a long time and doesn’t look like it’s going to go away anytime soon? This is the lingering CAPA, and it can be a problem because while it remains open and unresolved, there’s a good chance you’ll have the same issues cropping up. CAPAs that are left open for inordinate amounts of time have also been cited for observations by the FDA, so companies really need to be staying on top of them.

This is a challenge for many companies, especially when CAPA isn’t given appropriate priority. People get hired to do specific jobs in the organization, but when it comes to CAPA, it hasn’t been built into the capacity of their jobs. Where teams are tasked with project-managing CAPA, they often don’t have all the resources they need. Priorities like new launches tend to get pushed ahead while CAPA lingers in the background.

CAPA should get better priority because even if you are busy with getting a new product to market, a CAPA could indicate a problem somewhere in the whole process. The new thing you’re working on may be repeating the same mistakes you’ve already made, so maybe CAPA should get the priority first.

This does go against the conventional idea of “get revenue through putting out new product,” but think of the ramifications of letting issues linger. You could potentially upset customers, lose market confidence, or have bigger regulatory issues (such as recalls) you’ll have to deal with, costing more time and money.

3. The data used

I saw a note recently referencing a company that was content to use different systems for different pieces, even though none of those systems “talk” to one another. This means that data get buried in silos that are not accessible to the organization. This creates the challenge of forcing you to be reactive—you must wait for issues to happen before doing anything about them because you don’t have access to the data.

Being proactive is much more effective. This means being able to easily pull data from the various systems containing information about your product and processes from a single source of truth. You can then track and trend, notice issues ahead of time, and have a leading indicator rather than a lagging one. It’s absolutely crazy to think that the way companies are designing their systems and processes tends to make the problem worse rather than better. Think proactively.

This is what a software system like Greenlight Guru is designed to help you with—break down those silos of data and create a single source of truth, facilitating proactive action. Greenlight Grow has the ability to track, trend, and monitor all data in real time, which you can access at any time.

4. Poor root cause determination

The root cause is something we’ve regularly talked about, but it bears mentioning again due to being part of the common mistakes made with CAPA. It’s often associated with our first problem, where companies attach an arbitrary due date to CAPA, so there’s a rush to get through the activities that lead to the root cause.

By the time someone realizes it’s due imminently, they rush to get through and do a poor job of determining root cause, often regurgitating the problem rather than a cause. A good practice is to have cross-functional resources to help methodically get to the root of the problem with appropriate time and energy.

The problem with poor identification of the true underlying issue is that you’ll often resort to treating symptoms, which doesn’t really solve the true problem. There’s a good chance the issue will come back again if the root cause is not addressed. You’ll end up working on issues again that you’ve worked on before, which is not an efficient use of time for anyone.

5. Verification of effectiveness

As you take and complete actions, there’s another step you need to go through: verification that those actions have been effective. Imagine you need to change a design feature due to a problem. You implement the change, and the new design enters production. Once you’ve done this, you need a period of time to lapse to be able to verify that the action you took actually worked.

For example, you might need a few lots to be produced, or a certain number of products to reach the customer, so that you can really check that the design change has eliminated the problem for which you enacted the CAPA.

It’s amazing how many companies fail to do this verification of effectiveness. Sure, it’s understandable that things move on at a rapid rate, and focus gets put on other things, but verifying effectiveness is not only a requirement of CAPA, it also makes good sense for your business. You don’t want to be in a situation where your “fix” causes reputational damage or loss of confidence in your company because it failed to address the problem effectively.

Let’s say you are taking action with a design feature change, as per our example. You should be documenting verification of effectiveness as a priority. You can’t claim to have an overall good grasp of CAPA if you can’t verify that you’ve truly solved the problem.

Final thoughts

CAPA is part of life for medical device developers and must be carefully considered as part of a healthy quality management system. Consider the common mistakes outlined here and think about how CAPA is treated in your company. Is there room for improvement?

Here are a few more resources on CAPA:
Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices
13 Steps to Creating a Risk-Based CAPA Process
Debunking Eight Commonly Held CAPA Myths
What Should Really Trigger a CAPA?


About The Author

Jon Speer’s picture

Jon Speer

Jon Speer is the founder and vice president of quality assurance and regulatory affairs at Greenlight Guru, a software company that produces the only medical device quality management software solution. Device makers in more than 50 countries use Greenlight Guru to get safer products to market faster. Speer has served more than 20 years in the medical device industry and helped dozens of devices get to market. As a thought leader and speaker, he regularly contributes to numerous industry publications. He is also the host of Global Medical Device Podcast.



timeliness of capa

dear sir, finally u tried to say is no timeline for capa ?pls provide the answer pls sir