Quality Event Management

MasterControl's QEM system is a polished system that fits any organization, regardless where the quality event originates. Whether 1) all inputs are run through a QEM system that acts as a "command central" and disposition to the correct process (complaint or other process) from that point, or 2) data is directly entered via specific entry points of a Channel Management system such as complaints, deviations, OOS, etc., and funnel directly into a CAPA Management system, MasterControl has a corresponding QEM solution that can harmonize with and enhance overall QMS processes.

QEM System Challenges


MasterControl Advantages

Recurring Issues
Many companies struggle to determine the actual root cause of a quality event and as a result end up addressing the same event over and over again within their CAPA process.

Effective Root Cause Determination
Problem-solving algorithms and critical thinking logic are used to determine the actual root cause of issues, thus preventing them from recurring.

Death by CAPA
Many companies do not have an effective mechanism to differentiate between critical and non-critical issues. Consequently, many issues are run through a full CAPA process that should have never seen the light of day. This results in increased costs because valuable resources were focused on the wrong problems. All these issues can be easily solved by just installing MasterControl QMS system.

Risk-Based Filtering
Issues are evaluated based on their impact and frequency and the software system provides clear direction as to what the preventative and/or corrective actions should or should not be taken.

Inefficient Workflows
Manual QEM systems are inefficient, requiring an excessive amount of resources and time for searching, retrieving, routing and approving documents during inspections and audits.

Efficient Automation
The routing, delivery, escalation, and approval of each CAPA and all the related QEM forms is interconnected in the MasterConrtrol QEM system, making collaboration on key data very simple through each step of the process.

Disconnected QEM Tasks
A CAPA may be triggered by an OOS, an NCR, audit findings, customer complaints, or a trend analysis. With manual AMS systems, these sources are disconnected, making data collection slow, incomplete, or, even worse, inaccurate. It becomes increasingly more difficult to determine what needs investigation.

Connected Processes
MasterControl QEM solutions propagate the CAPA process throughout the entire organization. For example, the resolution of a CAPA can trigger a change control that coordinates an SOP change and retraining of employees on that SOP.

Lacks Visibility
The lack of ability to track and monitor CAPA cases can result in the delayed resolution of issues. Without a coherent reporting system, managers are unable to see the big picture of their quality management system. What's more, the reported data is frequently out of date.

Automatic Tracking
MasterControl QEM systems also make it easy to generate reports without IT involvement. Compare and contrast data over a large field of reporting options. The system can track all routing information and revision data entered into the electronic form, allowing the process owner to identify bottlenecks and monitor processing.

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