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Quality event management systems (QEM systems) are essential to ensure that products coming out of your facility are safe and effective, and they also help you identify opportunities for improvement. However, many companies mistake these systems for purely paperwork exercises. In reality, QEM is a data-driven approach that utilizes statistical analysis to understand what works in your manufacturing processes and what doesn’t—all while keeping an eye on critical quality issues such as CAPA (corrective and preventive actions).
Quality event management system (QEM Systems)
Quality event management systems (QEM systems) help companies manage quality events. They’re an important part of the corrective and preventive actions (CAPA) process, contributing to an organization’s ability to identify and reduce risk. A CAPA approach involves identifying the root cause of problems through a systematic analysis, taking action based on that analysis, then evaluating whether those actions were effective.
From this perspective, it can be helpful to think about QEM systems as the “cause” in a CAPA framework: they allow you not just to track and document your quality issues after they happen but also provide tools for analyzing them in order to prevent similar issues from occurring again in future products or services.
Qualification and validation
If you’re in charge of a company that needs to comply with regulations, then you’ll want to make sure that your quality event management system is up to snuff. QEM systems are an essential part of any CAPA plan and help you track your products from beginning to end. If a quality event occurs, you can use the QEM system’s reporting tools to collect information about it and determine how best to correct or prevent it from happening again.
It may seem intimidating at first but once you organize all your documentation, there are many benefits that come along with using a CAPA plan:
How does CAPA connect to QEM systems?
CAPA is a system for managing the process of identifying, evaluating, and correcting problems in a product or process. It’s a key part of quality management systems and is not a one-and-done process. You can’t just fix your issues once and then walk away feeling satisfied with yourself. CAPA is an ongoing effort to continuously improve your organization’s performance, quality, and safety. To keep those improvements happening, you need to keep improving your QMS as well!
Not a one-and-done process
CAPA is a continual process and not a one-and-done process. In other words, it’s not about fixing an issue once and then moving on to the next thing. Instead, it’s about identifying problems in your business so that you can fix them before they become bigger problems.
It’s also important to remember that CAPAs don’t just happen during a crisis. They’re something that should be done at regular intervals (like every quarter) so that you can identify potential issues before they become full-blown problems.
QEM systems can greatly streamline the CAPA processes
Quality event management systems (QEM systems) are used to manage quality events, which are issues that occur at any point in the production process. The CAPA process is a way of identifying, analyzing, and fixing problems. Once a problem has been identified and fixed, it can be determined whether to continue using the same method or change course completely by implementing corrective actions.
This process creates a culture of quality where employees know that the management respects, appreciates, and values their work. This helps prevent future errors from occurring because employees take pride in their work and want to do everything possible not only for their own benefit but also for the good of their organization as well as those around them who may rely on its services or products down the road.
These terms may seem complicated, but they’re just a part of any good QEM system. By creating a quality event management system that incorporates CAPA and qualification and validation, you can streamline your process for managing errors and mistakes at events. You can also reduce the risks that these errors might cause by using CAPA to prevent them from happening in the first place. While these systems are not perfect—they do take time to implement—they offer an extremely valuable service if used correctly.