Variance & OOS Management

Recording and investigating any process deviations from established manufacturing procedures or out-of-specification (OOS) test results is mandated by cGMP guidelines and is a key responsibility of the quality personnel in the FDA regulated industry.

Quality managers need a powerful automation and collaboration solution to successfully handle incidents of variance, deviations and OOS for a closed-loop assessment, investigation and reporting process.

MetricStream solution for Variance and OOS Management enables companies to establish and follow consistent procedures for managing variance and OOS incidents. The solution supports identification, assessment, investigation and reporting of cases along with the ability to track each incident. The powerful analytics and reporting capability with graphical dashboards give managers complete real-time visibility into the variance and OOS data and provides critical information for executing remedial corrective/preventive actions.

Recording Events: MetricStream solution module allows initiating variance and OOS events and assigns a unique case number that can be used to track the incident as it goes through various stages. It captures detailed information about the issue and supports categorization of issue type based on pre-defined criteria. Exceptions can be validated for possible assignable causes such as instrument malfunction or incorrect calibration. The solution also supports automatic intimation to supervisor and quality units about the incident, correlation with past data for trend analysis and conducting retests and recording the results to confirm if the event can be attributed to an assignable cause.

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Assessment and Investigation: The system routes the issues to laboratory supervisor and quality staff based on pre-configured rules for assessing preliminary findings and deciding subsequent course of action. Quality managers can trigger a full-scale failure investigation using a pre-defined procedure to identify the source of the issue in the manufacturing process including assigning the investigation responsibility to appropriate personnel with due date and breaking investigation into multiple tasks and activities such as retesting, re-sampling, averaging and assign to a team of investigators. The solution tracks the status of the investigation and measure progresses against milestones to ensure timely investigation. Failure to complete investigation by due date escalates the case as per organization hierarchy.

Review and Remediation: The solution enables evaluation of the investigation report to reach a decision regarding release or rejection of the batch and to judge the impact of the issue on other batches. It maintains records of complete data derived from all tests performed to ensure compliance with established specifications and standards. Quality department can initiate a corrective/preventive action (CAPA) and the case remains open till the action plan is carried out and results verified for effectiveness. Quality managers can track the status of the case as it automatically moves from one stage to the next based on organizations quality control procedures.

Reports and Metrics: The solution provides complete real-time visibility into the Variance and OOS data with analytics for trend analysis. Reports for status tracking, batch history, failed material classification, CAPAs initiated and audit trail can be readily accessed. Graphical executive dashboards and flexible reports with drill-down capability provide statistics and data by a variety of parameters such as production runs, plants, lots and batches.