In the life sciences industry, Quality Management is not only about creating a product that is fit for purpose, free of deficiencies, and meets customer expectations. It is also about more than simply conforming to specifications, adhering to protocols, or competitive superiority. While all of those things are extremely important, to achieve true quality, organizations must also be consistent. Quality Management Systems (QMS) aid in the achievement of consistent quality by providing organizations with the tools needed to control, monitor, and verify any activity or process that could impact conformance.

A quality event is a quality issue that must be assessed and triaged to determine if it should be escalated and to whom it should be escalated. It is the role of Quality Management to immediately capture all aspects of a quality event without first predetermining what the event is. This ensures that everything, every decision, is captured and nothing is lost. An organization demonstrates consistency and control when quality events occur, by documenting all events and the processes used to determine the type of quality events they are.

Anatomy of Quality Event Management

Integrating a quality event process into your QMS will ensure the consistent and accurate categorization of all events, allowing for appropriate triage and response to the event. To understand how the quality event process ensures everything is captured, it is important to understand the anatomy of a QMS quality event.

Capture - Documenting all quality events is the first step in the process. Capturing all events will ensure that nothing is overlooked. The capture process must be simple and intuitive to allow for the capture of all events or quality issues. This allows for reporting of the event at the source, ensuring appropriate information is captured.

Proper Identification - An effective event management process aids in the proper triage and categorization of events based on source, what happened, where it happened, if anyone was hurt, and the severity of the event. Inclusive capture of all events, combined with a controlled, documented, objective triage and categorization of events, allows an organization to focus its efforts on the most critical quality events.

Accuracy - Accurate event determination ensures no category of event is over- or under-reported because it is appropriately categorized the first time.

Integrated - Quality events must be integrated with other quality records such as CAPA, deviations, nonconformances, and complaints. Integrating events with the rest of the quality system will streamline processing. For example, automating the creation of a deviation upon completion of event triage can reduce errors and subsequent corrections, drive improvement, and improve quality event traceability.

Promotes Quality Culture - Appropriate event management encourages the inclusion of all departments in the capture of an event, allowing for the recording of the event at the time of occurrence to ensure proper recollection of the event. More importantly, it encourages inclusion, a hallmark characteristic of a quality culture, which is a leading indicator of quality maturity.

Why Quality Event Management: A best practice for compliance

Maintaining an event management process, while not a regulatory requirement, is a best practice for effective and efficient quality compliance. When event management is an integrated component of your QMS, it helps ensures your organization remains compliant with the many GxP regulatory requirements for life sciences.

Having a consistent and systematic triage process demonstrates a state of control to auditors, both internal and external, indicating that even when something goes wrong, your organization is able to manage the event. This leads to reduced audit findings and will contribute to shortened audit times.

As an integrated component of QMS, event processing reduces duplication of effort, i.e., no need for dual entry. It also improves traceability of the event from capture, to event determination or categorization, and escalation when appropriate to the other QMS records such as Deviation and Nonconformance, Complaint, or CAPA documentation. If the event becomes a deviation which then creates a CAPA, the linkage between the two actions is maintained, and your organization can now track initial triage, as well as the investigations and actions taken throughout the process. With an integrated ecosystem that includes quality event management, your business can make insight-driven decisions through a better understanding of quality events, resulting in reduced cycle times and improved end-to-end quality processes.

Quality event management is integral to harmonizing an enterprise QMS, allowing for vertical and horizontal reporting and trending across the organization. This end-to-end view of quality events improves visibility into the state of the organization’s quality health.

Solutions for next generation quality

SmartSolve®, from IQVIA, helps organizations maintain efficient and compliant quality management systems. SmartSolve’s integrated platform enables quality to become a centralized hub for continuous improvement throughout your business. This ability represents an opportunity for constructive changes – successful innovation, new processes, better performance – and leveraging this opportunity is a sign of quality maturity.

SmartSolve Quality Event Management is a next generation solution that streamlines the reporting and processing of a quality event or issue by tracking all quality events, simplifying event reporting, enabling risk-based assessment and escalation, and integrating with key quality systems.

When it comes to life sciences, avoiding mistakes is paramount, but when they do occur, the best solution is a thoughtful, planned, and organized response. A quality event management process provides an effective roadmap for the situation at hand, with the added benefit of continuous improvement to prevent future occurrences.