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ROI CalculatorHandling unforeseen events involves an organized way to deal with unplanned events that affect the quality, safety or performance of a product. It’s an important module of regulation, and the purpose of this is to change from a reactive way of doing business to a more proactive way.
The life sciences industry relies heavily on safe and effective products and quality management plays a big role in assuring the safety and effectiveness of these products at each stage of their entire lifecycle. Quality events, or deviations from set and defined standards, may occur at any time during the manufacturing and distribution of products and are frequent in the regulated industry and have to be handled properly to remain compliant with regulations.
This means it’s essential for life sciences professionals to understand and manage these events effectively to meet regulatory compliance.
A quality event is defined as a deviation from a defined standard or procedure. Quality events occur during each stage of a product’s development, manufacturing and distribution. Quality events can manifest themselves as different types of quality events including defective products or components, process deviations, and noncompliance. There are frequently occurring causes for these types of events including human error, inadequate procedures, equipment failure, and supply chain failures.
There are five key ways organizations can effectively manage unexpected quality events:
Minimizing quality-related incident's impact to your products or services and therefore ensuring patient safety, can only happen when incidents are identified and reported as soon as they occur. Organizations have the ability to identify and mitigate future risk by developing meaningful incident reporting procedures.
Once a quality related incident has been detected, it is essential that organizations conduct a thorough investigation and determine the root causes. Identifying the root cause will allow you to take corrective action and future preventative actions.
CAPA is critical in your organization's ability to manage quality incidents. Corrective action will allow organizations to address immediate issues, and preventive action will reduce the risk of future incidents. Therefore, by taking a proactive approach to CAPA, organizations can limit the likelihood of having a similar incident in the future.
In addition to allowing for quality incidents to be properly investigated, developed and implemented, having a complete and accurate documentation of the quality incidents allow organizations to be compliant with regulations and continuously improve the ability to quickly and effectively handle quality incidents. In your organization, you will need to maintain all records of quality investigations, corrective actions, preventive actions and results to ensure the entire process is transparent, accountable and traceable.
Effective communication in relation to all stakeholders involved will allow your organization to have a collaborative approach to problem solving. Therefore, by encouraging cross-functional collaboration, your organization will be able to take advantage of the collective expertise and insights available from all involved to assist with the most effective resolution of quality incidents.
