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CAPA/Remediation Management System: Features |
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Initiation
MetricStream CAPA/Remediation Management module allows initiating a remedial process, based on an issue such as a process failure, an exception event or an adverse event. It captures detailed description of the problem, event or symptoms that require corrective action along with parameters such as category, affected area and priority. Managers can choose one of more workflows that need to be triggered as the appropriate action type and set target due date. The module also supports associations with prior related issues and resolutions for trend analysis.
Investigation and Action Plan
The system assigns the task owner with the investigation task based on the event type. A cross-functional team of investigators may also be assigned the task depending on the issue 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 documentation problem. Task owner can chalk out the detailed action plan with an estimated completion date and assign responsibility to carry out the action plan to another user. Action plan can also comprise multiple activities assigned to individual task owners.
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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. Managers can track the completion status of the action plan based on pre-defined milestones and trigger alerts when delays occur. Issues with high severity can be marked for follow up activity after a specific time period to confirm effectiveness of the remedial action; the result of the follow up task is routed back to the appropriate executives for approval and final closure of the case.
Reports and Metrics
Executive dashboards provide enterprise wide visibility into the remediation and corrective action management process and bring high-risk areas into focus. The solution provides complete real-time visibility into the issue and remediation data with analytics for trend analysis. A transparent system with each case traceable from any desktop in the organization makes action plan 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 status, priority, action type, business units, processes and divisions.
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