CAPA

Qualis ERP's CAPA module lets small and mid-sized manufacturers run corrective and preventive actions, tracking a quality problem from the moment it is identified, through root cause analysis and fixes, to a final check that the fix worked. Corrective actions deal with a problem that already happened, preventive actions stop one before it starts, and a combined CAPA does both. It gives a manufacturer one place to prove that a recurring defect was solved. Each CAPA gets an automatic number, a priority, a type and a category (product, process, system or supplier). It moves through draft, open, investigation, action planning, implementation, verification and closed, and some transitions such as closing can require approval. The root cause tab supports 5-Why, fishbone and Pareto analysis, followed by a root cause statement. Severity, occurrence and detection scores from 1 to 10 multiply into a risk priority number, which sets the risk level. Each corrective or preventive action carries an owner, a due date and an optional verification flag. Verification records the method, the success criteria and a final verdict of effective, partially effective or not effective. A CAPA owner coordinates the work, an investigator digs into the cause, and a quality manager watches the overdue and pending verification counts and the effectiveness rate on the list page before a management review. CAPA builds on Non-Conformance Reports: choosing an NCR as the source links the two records, and a CAPA can be created directly from an NCR. It can also reference the products, suppliers and clients involved. Notifications alerts people when they become owner or investigator, when the status changes and when verification is requested, and attachments are kept in Document Management.