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Corrective action

Glossary

When an event or “nonconformity” occurs, the organization needs to take steps to fix it. Corrective actions are taken to resolve the root cause of the problem. On the other hand, correction is a knee-jerk solution that immediately fixed the problem.

 

For instance; a pipe burst and a water flooding incident occurred. The corresponding corrective actions address the root cause of the flood, such as fixing old pipes. Contrary to this turning off the water source is a correction that eliminates the cause temporarily.


Corrective action term is mentioned in several regulations and standards such as FDA, GMP, ISO standards (ISO 9001, ISO 13485). If we examine thoroughly the ISO Quality management standards, both are made a similar point.

According to ISO 9000, corrective action is an action to eliminate the cause(or causes) of nonconformity and to prevent a recurrence.

Likewise, according to ISO 13485, the following enlisted requirements should be documented in a procedure;

  • Review the nonconformity ( include complaints too)

  • Identify the root cause(s) or possible causes

  • Review the possible actions to eliminate the root cause and prevent a recurrence.

  • Plan and document the action(s) and implement it(them)

  • Verify that the action does not adversely affect the current requirements which are already complied with.

  • The last thing that the organization should perform at the end of each nonconformity management. Review the effectiveness of the taken action after a defined period.

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