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The corrective action system aims to identify, eradicate and reduce the chance of adverse events recurring.
These adverse events can result through any number of ways—whether through a complaint, an audit, or adverse event—there are often events coming into the system that signal that action is warranted. The corrective action process is often initiated at this point…but do all adverse events require a corrective action? Are all adverse events equal? In this white paper, we will discuss how the corrective action system can filter critical events from the noncritical, giving you visibility into which events warrant a corrective action and which can be easily fixed. We will also go beyond the iden- tification of critical events and show you where corrective action can integrate with the quality systems other processes to result in an intuitive and truly effective process for your company. IDENTIFIES MINOR EVENTS FOR IMMEDIATE RESOLUTION We will often see events in the system that are assigned a corrective action by default, regardless of criticality. This is because some companies may choose to take a “better to be safe than sorry” approach to their corrective action process. While this may appear to be effective at first, it can be detrimental in the long run—if you’re opening a corrective action for all events that enter the system, it could soon become impossible to keep track of the most critical events. Soon the system could be overloaded with minor, easily correctable events that are keeping your most crucial events hidden from view. To ensure your corrective action process is as effective as possible, you need to ascertain which events are most critical to your business and ensure that these are made visible. The corrective action system can make this easier for you by using investigations or “pre-corrective actions” to record adverse events without having to go through a full corrective action. If your corrective action system can identify minor events for immediate correction, this is a big step toward speeding up the process and bringing visibility on the critical adverse events lurking in your system. Opening too many open corrective actions can work against the process, hindering visibility of those events that are actually in need of a corrective action because they are lost in a sea of immediately correctable events. So how can we determine the need for a corrective action? The ability to filter these noncritical from the critical events is crucial. This is where risk management comes in.
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