Deviations and Investigations

Deviations and Investigations are both included in the Quality Management module. Each process can stand alone, however often deviations lead to an investigation (and possibly a 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 deviations and investigations documentation that makes search and retrieval easy, storing all subsequent documentation.  It also ensures a timely resolution of deviations and investigations; this helps companies ensure industry and regulatory compliance, improve product quality and reduce costs associated with deviations and investigations.

Quality Manager automates the development, approval, implementation, verification and effectiveness of deviations and investigations. Since it is part of the Quality Manager module, an investigation event can be spawned from a deviation, complaint, OSS, 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.

Out-of-the-box deviation and investigation forms are provided, however many companies prefer to recreate their existing forms using Quality Manager’s configurable forms tool. Deviation forms capture information electronically including description, area of deviation, event date, affected products, impact and deviation type. Reports are available to track deviation information by lot/batch number or other criteria.

Investigation forms are also completely configurable; our standard form contains fields to capture lead investigator, initial disposition, impact assessment and immediate actions required. If the investigation warrants a CAPA, the two events will be linked in the system.

A coding system is available to help assess the risk of the deviation. The task manager ensures proper closure by tracking verification of the response to the finding. New 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. Tasks can be set to be dependent on another task so as one worker finishes a task, the next person is notified that a new task is waiting to be completed. Any recurring task activities can be included in a task profile, however users have the option to add tasks on an ad-hoc basis to individual deviation or investigation 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.