A firm’s corrective and preventive action (CAPA) program is a very important part of our assessment. When
something goes wrong, the company is responsible for finding out why it went wrong. It’s very important not only to
identify the problem, but the scope of the problem, in order to properly investigate the root cause and take effective
measures to preclude the problem.
In many cases, companies tend to look at a problem in a narrow way — they’re just concerned with a particular defective batch. But the problem may not end by simply throwing away that batch. If there’s an underlying problem in the process, the same thing will happen again. CAPA is about looking at the big picture. Why did this problem happen? Is there one factor or many factors contributing to it? How can you improve the process? You really have to go beyond the defective product and look at the process. It is important to note that a corrective action program is retrospective — the problem has already happened and measures are taken to improve the process. Firms with effective quality systems include an ongoing assessment, or “continuous improvement” program, to identify and reduce variability in their process in a prospective manner, before the process produces unacceptable product.
