Ceptara

The corrective action process is arguably the most important component of a quality assurance program. Without an effective corrective action program, problems will continuously repeat themselves, continuous improvement is impossible, and it is unlikely that any of the other quality system elements will work effectively. As for virtually every other management program, success of the corrective action process is directly related to management commitment. Nevertheless, even in those organizations where management works hard on the corrective action program, the results are frequently either ineffective or counterproductive. A major cause of an ineffective corrective action program is failure to consider the effects of variation.

In concert with this idea, Dr. W. Edwards Deming1 cites an important statement by Dr. Lloyd S. Nelson: “Failure to understand variation is a central problem of management.” In this article, the phrase “corrective action” is used rather loosely. It includes both corrective and preventive action as defined in ISO 9000 Element 4.14. It also applies to similar activities, such as instrument calibration and audit findings (Elements 4.11 and 4.17 of ISO 9001), that are typically included in other quality system sections. Finally, it includes much of management’s efforts to improve processes as well as day-to-day decision making outside the realms of the quality assurance program.