The corrective and preventive action (CAPA) process continues to be the most widely shared challenge for most medical device companies.
 
While the regulations are relatively clear regarding well-documented CAPA procedures, their implementation is still one of the most common compliance issues companies get caught up on in their development cycle.
 
For the good of your company, your product, and your end users, planning an effective CAPA strategy is well worth the time. If you’re looking to improve or overhaul your CAPA process, take a look at the five most common issues we hear about and how you can avoid them.
 
1. Reactivity Instead of Proactivity
We’ve gotten good at corrective action, but we’re not so good at preventative action. It might seem a bit like the old chicken and the egg adage, but with a greater focus on nonconformances and less complaints, we will spend less time on corrective issues. Starting with quality in mind from the outset of device design, we can reduce the need for corrective action.
 
One of the challenges for the medical device industry is that we’re often stuck waiting on data to take action. A complaint or nonconformance relates to something that has already happened. With a more proactive mindset, we could seek patient and customer feedback from the outset before there’s any kind of issue at all.
 
While each company and each device is different and presents its own unique set of requirements, companies should proactively establish criteria based on product knowledge and take the steps to prevent issues from happening in the first place.
 
2. Overuse vs. Underuse
Are CAPAs used too frequently or not frequently enough? Put simply, a CAPA should be used to address a systemic issue; be diligent, but not every issue you come across warrants a CAPA. If you turn every complaint into a CAPA, you will overburden your already limited resources and costly mistakes will likely follow.
 
That said, don’t wait for something bad to happen before you issue a CAPA. For example, if there is a fitting that is not operating as it should, be proactive about investigating whether that fitting is used in any other products or processes. This method allows you to address real issues well before they become too complex to tackle without a CAPA.
 
3. Lack of Cross Functionality
In most organizations, CAPA is owned by the quality team and this group makes the decisions about whether a CAPA needs to be issued, often unilaterally. However, CAPA should be treated like any other major project: all teams and functions affected by the program should have a seat at the table. This structure is the ideal way to determine root causes or underlying issues and doesn’t dump CAPA at the quality team’s doorstep.
 
Cross-functional teams are vital because they provide a holistic view of what is truly going on within an organization. If you place the full responsibility of a CAPA within one department they will inevitably apply their own biases and critical information will be missed. This is a poor strategy because seldom does CAPA problems involve only a quality issue.
 
Cross-functional management review meetings are also key to compliance and quality. More than just an annual “check the box” activity, Management Review Boards review, assess, evaluate, prevent, correct, and control quality issues. A review of this magnitude requires cross functionality and can help prevent receiving a 483 Observation during your next inspection.
 
4. Poor Root Cause Determination
We often notice little time is spent determining the root cause of an issue. Simply restating the problem with different wording and passing that off as the root cause determination is incorrect; it’s the symptom caused by the root cause.
 
The danger of not properly identifying and defining a root cause is that you’re likely to encounter the same issue again—perhaps as a recurring event—because the real root cause was never addressed or resolved.
 
In terms of determining the root cause of an issue, there are many different types of methods one can use. A personal favorite of mine is the “Five Whys” technique. This method is pretty true to its name as it involves asking more or less five “why” questions until you get to the bottom of the issue with an actionable root cause. The reason why I say “more or less” is because sometimes it will only take a few questions while other times, it will take closer to 10; every situation is unique, so it just depends.
 
Let’s look at an example using the standard five question sequence to determine the root cause of a device that broke during use.
 

1. Why? The device is being exposed to extreme forces at the point of use.
2. Why? The use technique at facility X is different than intended.
3. Why? Facility X did not receive in-service training.
4. Why? There is no resource assigned to provide training for that facility.
5. Why? No process to confirm that all use facilities require in-service training before products can be sold to a facility.

 
5. Poor Definition of a CAPA Process
For the last several years, CAPAs have remained as the leading culprit for 483 Observations issued during inspections. If your company is a recipient of one of these, it usually means one of three things:
 

1. Your defined CAPA process is not being followed.
2. Your defined CAPA process is not compliant.
3. You have not defined a CAPA process.

 
There seems to be a common theme here. Try issuing an annual “CAPA on your CAPA”—an internal review of your CAPA processes to ensure everything is working properly, and if not, what you need to do to address gaps. This holistic approach to managing CAPAs can also help you become attuned to patterns, improving your proactive approach. Think of your own process in terms of “PACA” rather than CAPA. Ideally, we want to be proactive first, that way the corrective action is either unnecessary or limited in scope.
 
Conclusion
For medical device companies, CAPA management should always need to be at the forefront. However, the costly and exhaustive problems that sometimes result can be avoided if managed properly, and early, by the organization.
 
Assess your own CAPA processes and implement any necessary changes now, allowing you to spend less time putting out fires later. Having clear criteria outlined and understood by all team members, as well as adhering to that criteria, is a great start. If we can flip CAPA on its head, the proactive/preventive action is the first and most important step we must follow.