CAPA & Nonconformance

Managing nonconformances (NCMs) as well as Corrective and Preventive Actions (CAPA) is essential to a solid quality management system and is central to a closed-loop, continuous improvement process. Traditionally, manual paper-based, homegrown or stand-alone applications have managed the process in disparate systems and have relied on individual departments. 

IQS provides a comprehensive NCM and CAPA software solution that enables companies to streamline their 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. IQS’ solution provides end-to-end exception and change management capabilities to alert companies  of potential problems 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.

Nonconformance Recording:

The solution allows initiating a nonconformance and assigns a unique number that can be used to track the report as it progresses through the various stages. It captures detailed information about the issue and supports categorization of issue type based on pre-defined criteria, severity level and identification of the responsible department or supplier. The solution also supports correlation with past data and provides a decision on the need for containment or corrective action.

Review and Approval:

The solution routes the nonconformance to assigned 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.

Investigation and Action Plan:

The system assigns the corrective action owner, and a team can be assigned for further task development. Automated workflows drive the root cause analysis to identify the source of the problem and categorize the issue issue, such as process, supplier, training error or equipment/device issues.

Approval, Execution and Closure:

The solution routes root cause analysis and action plan detail for review and evaluation. Approval of the plan sends automatic task assignment to the user responsible for carrying out the action plan with the assigned due date and failure-to-act-in-time triggers. 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 after a specific time period to confirm effectiveness of the action; the result of the follow up 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 NCM and CAPA process with easy status tracking. Reporting is available with each NCM or corrective action across the organization.  It may also be tailored to reflect the specifics issues as tied to a supplier, customer, process, etc.