Corrective/Preventive Actions (CAPA) and Nonconformance Management

Corrective/Preventive Actions (CAPA) and Nonconformance Management are both included in the Quality Manager module. Each process can stand alone, however often nonconformances lead to CAPA and the event forms can be linked to ensure proper follow-through and closure. 

Moving to an electronic system provides a centralized repository for all CAPA and Nonconformance documentation that makes search and retrieval easy, storing all subsequent documentation.  It also ensures a timely resolution of CAPAs; this helps companies ensure industry and regulatory compliance, improve product quality and reduce costs associated with CAPA and nonconformance.

Quality Manager automates the development, approval, implementation, verification and effectiveness of CAPAs. Since it is part of the Quality Manager module, a CAPA event can be spawned from an audit, complaint, deviation, nonconformance, or any other quality process. When utilized with the Document Control and Training modules, the Quality Manager system is a complete “closed-loop” system. The processes are connected within the system and reports and/or trend alerts can be set so managers are never out of touch with their quality processes.

An out-of-the-box CAPA form is provided, however many companies prefer to recreate their existing CAPA form using Quality Manager’s configurable forms tool. Forms capture complete information about a CAPA, including implementation, from identification of the problem to investigation of root cause through correction of the problem and prevention of recurrence.

Nonconformance configurable forms capture information and analyze information by material, shift, machine, supplier, etc. When a nonconformance spawns a CAPA, the two events are linked in the system and form a parent-child relationship. Reports are automatically generated and distributed based on pre-determined criteria.

The task manager ensures proper closure by tracking verification of the response to the finding. Tasks are automatically sent via email to Outlook or other email systems, so users do not need to be logged into the system to be up to date on their workload. Any recurring CAPA or nonconformance-related activities can be included in a task profile, however users have the option to add tasks on an ad-hoc basis to individual events. Quality Manager automates task assignment and follow-up via automatic e-mail notification. It incorporates escalation capability for any task not completed by deadline.

Quality Manager also provides advanced tracking capability every step of the way, from initiation to investigation and all the way through closure. Trend Alerts can be set to notify managers if a problem code reappears after CAPA is in place.