Non-Conformance & CAPA

Managing material and process nonconformance and follow-up Corrective and Preventive Actions (CAPA) is the core of a sound quality management system and is central to a closed loop, continuous improvement process. Traditionally, homegrown systems, stand-alone applications, or even manual paper-based systems have managed the process at the departmental level to serve the needs of specific user groups. Such point-solutions fail to address systemic quality problems because they lack broad enterprise reach.

Companies are now recognizing the significant impact of quality control on profitability and are taking an enterprise-wide approach to automating Nonconformance and CAPA management. Companies regulated by FDA or those following standard such as ISO are leading this trend, as they have to follow external mandates on quality management and need to lower their risk of non-compliance across all operations.

MetricStream provides a comprehensive non-conformance and CAPA software solution that enables companies to streamline their Nonconformance and CAPA processes across the enterprise. The solution supports identification, evaluation, segregation and disposition of nonconforming material as well as case investigation and tracking, leading to the CAPA process. Based on the industry standard 8D methodology, it provides end-to-end exception and change management capabilities to help companies capture problem data from anywhere in their operation, conduct investigation to determine the root cause, manage the entire preventive and corrective process, implement changes, and ensure that the problem is resolved effectively. The powerful analytics and non-conformance report capability with graphical dashboards to track each case from initiation to closure gives managers complete real-time visibility into the quality system.

Nonconformance Recording: The solution allows initiating a nonconformance 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 and severity level and identification of the responsible department or supplier. The solution also supports correlation with past data for quick analysis and decision on the need for containment or corrective action.

Related Products Issue Management   CAPA / Remediation Training Management     more ...

Review and Approval: The solution routes the nonconformance issue to Material Review Board (MRB) or other authorized users based on pre-configured rules for review, approval, and disposition. Procedure for rework, retesting and reevaluation can be initiated after determining quantities for return to vendor, use as is, rework and scrap. The data is applied to defects PPM metrics to enable constant monitoring of supplier performance.

Investigation and Action Plan: The system assigns the CAPA owner with the investigation task based on the responsible department and event type. A cross-functional team of investigators may also be assigned the task depending on the severity. Automated workflows drive the root cause analysis to identify the source of the problem and categorization of the type of issue such as a process issue, human error or equipment problem. CAPA owner can chalk out the detailed action plan with an estimated completion date and assign responsibility to carry out the action plan.

Approval, Execution and Closure: The solution routes root cause analysis and action plan details for reviews and evaluation. Approval of the plan sends automatic task assignment to of the user responsible for carrying out the action plan with the assigned due date and failure to act in time triggers escalation. Quality managers can track the completion status of the action plan based on pre-defined milestones and trigger alerts when delays occur. CAPAs with high severity can be marked for follow up activity after a specific time period to confirm effectiveness of the action; the result of the follow up task is routed back to the quality unit for approval and final closure of the CAPA.

Reports and Metrics: The solution provides complete visibility into the Nonconformance and CAPA process with easy status tracking. A transparent system with each case traceable from any desktop in the organization makes process management and execution a predictable and efficient process. Graphical executive dashboards and flexible reports with drill-down capability provide statistics and data by a variety of parameters such as by batches, plants, status, category, and action type.