Incident Management

The Incident Management feature introduces a structured approach to capturing, investigating, and resolving quality issues within the Quality Module. Serving as the centralized entry point for quality concerns, the Incident Form ensures that reported issues are accurately documented, assessed, and swiftly escalated as needed. By seamlessly integrating with Investigations, Action Items, and CAPA (Corrective and Preventive Actions), this feature empowers organizations to proactively manage risks, drive compliance, and enhance overall product and service quality.

Incidents are categorized as Main Types, with the option to include Sub Types for better organization and tracking. The workflow-driven approach ensures that incidents progress through assessment, investigation, assessment, root cause analysis, and corrective action implementation, helping to prevent recurring issues. Key fields such as Record Type and Team allow organizations to configure workflows and assign responsibilities effectively.

Additionally, automated notifications, real-time dashboards, reports, and analytics provide visibility into issue trends, ensuring proactive resolution and continuous improvement. Integrated audit trails and compliance tracking help maintain detailed records, supporting regulatory adherence and quality assurance.

By offering a systematic and structured process for incident resolution, this feature enhances quality control, risk management, and overall operational efficiency, allowing organizations to maintain high standards in product and service delivery.

The Incident Workflow Processing feature streamlines incident management by automating submission, validation, and assignment. It enhances compliance, improves transparency, and reduces manual intervention.

When an originator submits an incident, the system verifies its type and record type to check for a predefined workflow. If a match is found, the record enters the workflow; otherwise, the originator is notified.

Role-based access controls ensure data integrity. The originator’s access is downgraded to read-only, while team members gain controlled visibility. Assigned authorities can manage incidents via the Assignments View, ensuring accountability.

This workflow-driven approach enables efficient incident tracking, structured collaboration, and proactive issue resolution through automated transitions and notifications.