Differentiate between Deviation Management and CAPA. How CAPA is important to Deviation Management (general)?

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Deviation Management is a subset of CAPA (Corrective and Preventive Action). When a deviation occurs, the first order of business is to contain the problem and to determine if the problem has occurred elsewhere. Next, a record of the deviation is maintained for future reference, in the event that a trend may be identified later.

Deviation management alone, while necessary, does not correct problems. For this reason, CAPA involves a thorough investigation into the root cause to prevent future recurrences. In the case of Preventive Action, a deviation may not have occurred, however, a potential problem may have been identified. This is normally not considered a deviation, yet should be captured by the CAPA system.

CAPA, more than a system, is a culture and a state of mind of not living with problems, but rather correcting them and continuously improving the quality system. The CAPA structure is the framework, but is of limited value if the entire organization does not embrace the philosophy behind it.

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