eQMS Issue Investigation Module

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eQMS Issue Investigation Module

A central hub to manage investigations of identified issues
Manage identified quality and non-quality issues in one place. Record an identified issue, perform the investigation with the collected evidence, initiate actions and track the progress of each case from start to finish.
Embedded in the eQMS system
The eQMS Issue Investigation Module is a powerful investigation tool embedded in Novunex eQMS that allows users to escalate events from audits, nonconforming material discoveries, out-of-tolerance equipment, and process inspections. The module helps users quickly identify, investigate, and respond to issues to efficiently address risks and problems.
Start issue investigations from scratch
You can start an investigation from scratch using an easy-to-use electronic form with dropdown selections for issue source, defect codes, and other attributes for built-in Pareto charting. The module is meant to help you collect relevant information from any source, including services, manufacturing, suppliers, and customers.

Electronic approval and progress tracking

Issue Investigation Module in Novunex eQMS lets you keep track of the progress of a particular investigation and use electronic approval where key stakeholders need to approve decisions like corrective action initiation.

Dashboards and charts to track the status

Track your open and resolved issues. See at a glance who is working on what issue and the status of each issue. Any updates are instantly reflected in the system, giving you a clear picture of who is doing what when it comes to crucial activities like investigation and containment actions.
Risk assessment and impact analysis
A tool that provides a step-by-step process to assess the severity of an issue, estimate its potential frequency and impact, prioritize efforts and assign resources. This helps to identify what corrective measures will be needed to reduce risk and mitigate associated side-effects.

Decision on corrective actions

The eQMS Issue Investigation Module lets you quickly decide if corrective actions must occur. The module provides a structured form to help guide you through the investigation and decision process with stakeholder approval before corrective actions are initiated.

An audit trail of the investigation process

Designed to ensure compliance with the full spectrum of regulatory requirements, best practices, and company standards. As new issues that fall outside specific parameters are identified, you can capture them in an easy-to-use electronic form with an audit trail for future reference and regulatory compliance.
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