Depending on the level of risk, Quality Management or the Quality Improvement Team should assign responsibility for developing and implementing the preventive action. The assignee(s) should keep a record of the preventive action, using the Preventive Action Report ISO Template. They should attach related correspondence, notes, etc., to the QP1050-1 PREVENTIVE ACTION REPORT as needed.
This report describes the potential nonconformity and action(s) taken to prevent or reduce likelihood of occurrence. During Management Reviews, the effectiveness of preventive actions should be reassessed and changes initiated and implemented, if required. The philosophy underlying preventive actions is not about avoiding so much as it is about ensuring positive outcomes.
The preferred action is to design in quality, significantly reducing the cost of poor quality, eliminating the need for inspections, and increasing process capabilities. The difference between corrective and preventive actions is reaction versus anticipation: if the company is reacting to an event that has occurred, it is taking corrective action. If the company recognizes the potential for a problem and it acts to prevent the problem “or reduce the likelihood of the problem occurring”, it’s taking preventive action.