A poorly defined or implemented process is the number one reason the FDA issues 483 observations to medical device companies. Define your CAPA process, follow your process, and ensure that it is compliant. With Greenlight Guru, the CAPA process and workflow is well-defined and built into the platform for your use day one.
When you have a system or a process where all the things, even design controls, feed into it and are connected in one single source, you don’t have to search in other places where the data is lurking. Nothing is lost. Data is complete. Finally.
Visibility is SO important. You can’t manage what you can’t see. Today, many companies have a multitude of dierent tools, many of which are disconnected, disjointed, and paper-based, which is problematic because you don’t have visibility into all the sources of data and information to make decisions. Bad decisions are made when you don’t have all the data or when you don’t really know what is going on.
By managing all data and CAPA processes in a single system, you know how they relate to all other parts of your quality management system and you have visibility into how your customer complaints, audits, nonconformances, and other quality systems impact your CAPA system. Now, you have the cross-functional visibility in a single system to make decisions and take the right action.
Today, medical device companies seem to place most of their CAPA eforts on correcting issues rather than preventing them in the first place. Many times, CAPAs are reactions to issues that have already occurred. This causes a significant strain on you and your business. You have been forced to be reactive because there is no way to pull the data together and make informed decisions. Bad decisions are made when people don’t.
Now, you can have a system in place to assess and identify issues before they become problems. You can see quality issue trends in real time and correct them before they become a regulatory issue. Make proactive quality decisions instead of reacting to situations.
A CAPA should be reserved as a process to deal with potential systemic issues. However, some companies issue CAPA in nearly all situations. Before long, there are dozens of CAPAs, in addition to the complaints, nonconformances, and other quality events. This puts an undue strain and burden on a medical device company and the quality management process. Other companies may underuse CAPAs even though there are serious quality events happening.
Realize that your CAPA process is best utilized for systemic issues. Leverage CAPA appropriately.
In today’s environment, there is very little time spent determining a root cause. Rather, the prevailing practice is to restate the problem statement or issue description as the root cause, which is rarely the case.
Take the necessary steps to properly define the root cause so any subsequent actions within your CAPA actually hit the mark. If you don’t, the CAPA you are trying to address will likely still be present despite the actions you take. By determining the root cause, you will ensure your CAPAs are more eective in the long run. Easily trace CAPAs back to their root cause, even if it’s in design control.
As an organization, CAPA is the foundational piece to know if your overall quality management system is eective. In real time, ANY time, know how healthy your organization is and where the opportunities for improvement are.
A solid CAPA process is foundational and a key indicator of the health of a medical device company.
Since anything can be tied to anything else in the system, you have a single system where all the procedures, tasks, root causes, etc. are tied into a single workflow designed specifically to manage a medical device company CAPA process.
And because everything’s connected...you can assign CAPA-related tasks to your team and track everyone’s progress towards due dates. You can connect your investigation activities and results to your root cause determinations allowing your corrective and/or preventative actions to target the true problem. And you can access your CAPA artifacts and provide them to the auditor in a couple of clicks with absolute confidence nothing has changed.
While a healthy CAPA process is key to a healthy quality management system, it is equally important to understand how all QMS processes connect with CAPA. Ensure full reciprocal traceability and auditability throughout the Greenlight Guru platform since you can easily see what was changed, why it was changed, when it changed, who changed it and what was impacted as a result of a CAPA.