Non-Conformance & CAPA
Manage, measure and drive continues improvement

 

Non Conformance

Managing material and process non-conformance and follow-up Corrective/ Preventive Actions (CAPA) is core to a sound quality management system. It is also important for closed-loop continuous improvement. Traditionally, homegrown systems, stand-alone applications, and manual paper-based systems have been used to manage the non-conformance process at the departmental level. However, such systems 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 non-conformance and CAPA management. Companies regulated by FDA or those following standards 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 Non-conformance Solution

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

Non-conformance Recording: The MetricStream solution helps initiate a non-conformance incident, and assigns a unique case number that can be used to track the incident as it goes through various stages. The solution captures detailed information about the incident, and supports categorization based on pre-defined criteria, as well as the severity of the incident and the responsible department or supplier. The solution also supports correlation with past non-conformance data to quickly analyze and decide on the need for containment or corrective action.

Review and Approval: The MetricStream solution routes the non-conformance issue to the Material Review Board (MRB) or other authorized users based on pre-configured rules for review, approval, and disposition. Procedures for re-work, re-testing and re-evaluation can be initiated after determining the quantities of non-conforming material that need to either be returned to the vendor, used as is, re-worked, or scrapped. The data is applied to defects PPM metrics to enable constant monitoring of supplier performance.

Investigation and Action Plan: The MetricStream solution assigns non-conformance investigative tasks to the CAPA owner based on the responsible department and event type. A cross-functional team of investigators may also be assigned the tasks depending on the severity of non-conformance. Automated workflows drive a root cause analysis to identify the source of the non-conformance, and categorize the incident as a process issue, human error, or equipment problem. CAPA owners can chalk out a detailed action plan with an estimated completion date, and assign responsibilities to implement the action plan.

Approval, Execution, and Closure: The MetricStream solution routes non-conformance root cause analysis and action plans for reviews and evaluation. As soon as the plan is approved, automatic task assignments with due dates are sent to the user responsible for carrying out the plan. Failure to act in time triggers escalations. Quality managers can use the solution to 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 flagged for follow-up activity to confirm the effectiveness of the action. The result of the follow-up is routed back to the quality unit for approval and final closure.

Reports and Metrics: The MetricStream solution provides complete visibility into the non-conformance and CAPA process with easy status tracking capabilities. It enables a transparent environment with each case traceable from any desktop in the organization. Thus process management and execution is made a predictable and efficient process. Graphical executive dashboards and flexible reports with drill-down capabilities provide statistics and data on non-conforming material by a variety of parameters such as by batch, plant, status, category, and action type.