QTI Quality Systems — Corrective Actions And Preventive Actions (CAPA)

The purpose of QTI's Corrective Actions and Preventive Actions (CAPA) policy is to continually improve the Quality Management System (QMS) through the discovery of problems and potential problems associated with product, process and the QMS. Continued improvement is achieved by controlling potential and actual problems, investigating them, reviewing them and monitoring them throughout the organization. The Quality Metrics is a quarterly reporting tool comprised of key performance indicators for QTIs QMS used to communicate trends, problems, effectiveness and their status to management.

The Quality Metrics key performance indicators are comprised of but not limited to Laboratory Investigations (ARIR & OOS), Procedural Devi ations (PD), Change Controls (CC), Audit Observations (AO), Customer Inquiries (CI), as well as project workflow performance. This information includes identifying, investigating quality problems and potential problems commensurate to their risk. The appropriate corrective and preventive actions are created based upon a root cause analysis, to prevent reoccurrence of the problems. This information is communicated to the responsible personnel performed and completed as assigned. The Quality Management Team (QMT) manages these actions to verify and validate that they are effective, as well as escalate those actions that have not been addressed in the allotted time. The Quality Assurance Unit (QAU) provides the Executive Management Team (EMT) quarterly updates of all outstanding CAPA activities, along with summaries and recommendations for improvement.