A corrective action is a reaction to a problem that has already occurred. It assumes that a nonconformance or problem exists and has been reported by either internal or external sources.
The actions initiated are intended to:
- a) Fix the problem and
- b) Modify the quality system
The process that caused it is monitored to prevent a reoccurrence. The documentation for a corrective action provides evidence that the problem was recognized, corrected, and proper controls installed to make sure that it does not happen again.
A preventive action is initiated to stop a potential problem from occurring. It assumes that adequate monitoring and controls are in place in the quality system to assure that potential problems are identified and eliminated before they happen. If something in the quality system indicates that a possible problem is or may develop, a preventive action must be implemented to avert and then eliminate the potential situation. The documentation for a preventive action provides evidence that an effective quality system has been implemented that is able to anticipate, identify and eliminate potential problems.
A timely, well documented, Corrective / Preventive Action program validates a quality system that is not only capable of identifying potential problems but also effectively correcting them when they do occur.