The Corrective Action Program or CAPA is a series of means used by companies to find faults in their manufacturing process. The goal is then to eliminate these faults, nonconformity and other negative aspects. These corrective actions can be taken to both stop a current nonconformity and to keep other nonconformities from happening in the future. The Corrective Action Program is put into motion
. typically as a result of customer complaints, excessive nonconformity found through either employee comments or through an internal audit. Both stemming and preventative actions are taken then to eliminate all or most nonconformities and to prevent similar occurrences from happening in the future. There are three common concepts that all Corrective Action Programs must share. The first is a set of identified and documented sources of data that can be used to determine the cause of the nonconformity. Second is a RCA or root cause analysis, which is used to search for the central cause of the discrepancies and to determine if such discrepancies have occurred in the past under different circumstances. The last process determines all possible similarities to any other discrepancies that have occurred in the past and attempts to determine similarities to potential future discrepancies in order to prevent them from happening in the future. These preventative measures include preventative maintenance, change of protocol or added employee training to deal with such problems or keep such problems from repeating. Many companies allot an extensive budget for their preventative action programs. This is due to the fact that such programs are generally a lot less expensive than cleanup would be. For instance, installing an alarm that signals whenever a boiler overheats might cost $100, but having the boiler overheat and explode would cause thousands of dollars in damages. As such, the preventative action program is widely used and endorsed. More Reference Links: http://www.ich.org/products/guidelines/quality/quality-single/article/good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients.html http://www.ispe.org/error_on_page?url=/gamp/
