Quality Event Management

Automatically capturing and signaling quality events.

An eQMS allows you to predetermine thresholds that indicate a problem is occurring. For example, you may need to keep track of how long certain activities are taking, when a temperature falls without acceptable range limits, or when a deliverable is overdue.

As your system reliably captures data throughout normal daily operations, it can respond to the data in real time and notify users when those thresholds are met. A robust eQMS acts as an early warning system and makes it possible to initiate quality event management processes in real-time – something that’s nearly impossible if you rely on manual data capture.

Opening data silos to allow for thorough quality event evaluation and investigation.

Most QEM solutions are disconnected, meaning they do not tie quality data and processes together. If you are using paper to handle QEM tasks, it becomes especially difficult to share the occurrence of an event across your organisation, let alone link it to related events, investigate it, coordinate with key stakeholders, and resolve it.

Using advanced search and reporting capabilities within an eQMS it’s possible to identify and compare multiple quality events and track them over time. It’s much easier to identify patterns and root causes when you have access to more data that you can quickly search and analyze because it is in a digital format and stored in a centralised location. 

Initiating, automating, and coordinating QEM processes.

Once you discover a quality event, the journey of quality event management begins. It entails several phases and steps within each phase. However, these are not set in stone and each organisation must design efficient processes to determine the root cause and ensure quality events are handled in accordance with standing regulations, industry best practices, and internal standards. Further, these processes must be documented. This can be daunting if you’re trying to handle everything on paper.

An eQMS provides electronic templates that can form the basis of your QEM processes. It is helpful to have a set of standardised approaches. It is even better to have the option to dynamically tailor processes to the event when necessary or directly link them to another related process. 

Connecting directly with risk management and CAPA systems.

Effective QEM requires companies to accurately navigate the risks that quality events introduce to a quality or manufacturing environment. By determining how critical an event is or how frequently it occurs, a quality manager can determine if it exceeds a risk threshold and/or needs to be escalated to a CAPA.  

An eQMS allows users to effectively execute CAPAs if it becomes necessary and extend QEM to other sources of quality incidents, such as nonconforming materials, rework documentation, returned goods authorisations, etc. Continuous systemwide connectivity can ultimately reduce the number of quality event occurrences and their impact. 

Verifying effective mitigation and follow-up.

The final step in closed-loop QEM involves verifying that the problem has been routed correctly or resolved and that all phases and steps have been completed. If you are using a paper-based system to manage quality events, this requires reviewing and analyzing a lot of paperwork.

If you are using an eQMS, one that is equipped with advanced searching and reporting capabilities, you can quickly mine your system to verify completeness and demonstrate compliance. 

In addition to relying on the initial thresholds you set, you can track and trend improvements over time to verify remediation effectiveness. If you discover you still need to make some corrections, you can easily begin the process again and come closer to a state of continuous improvement.