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RESEARCH ARTICLECorrective and Preventive Action: An Imperative Quality Management Perspective in Pharmaceutical Industry Sea A. Dhamne1×, Ramesh R. Dandagvhal2, Prashant L. Pingale1, Sunil V. Amrutkar2
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How to fill out corrective and preventive action

01
Identify the issue or nonconformity that needs to be addressed.
02
Investigate the root cause of the issue to prevent it from happening again.
03
Develop a plan of action with specific steps to correct the issue.
04
Implement the plan of action to address the issue.
05
Monitor the effectiveness of the corrective action taken.
06
Document the entire process for future reference.

Who needs corrective and preventive action?

01
Any organization or individual who wants to improve their processes and prevent future issues from occurring.
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Corrective and preventive action is a set of actions taken to eliminate the root cause of a nonconformity, defect, or other undesirable situation, in order to prevent its reoccurrence.
Any organization or individual involved in a process or system that produces a nonconformity or undesirable situation is required to file corrective and preventive action.
To fill out corrective and preventive action, one must identify the nonconformity or undesirable situation, determine the root cause, develop a plan of action, implement the plan, and monitor its effectiveness.
The purpose of corrective and preventive action is to improve process efficiency, enhance product quality, and prevent the recurrence of nonconformities or defects.
The information required to be reported on corrective and preventive action includes the description of the nonconformity, the root cause analysis, the action plan, the responsible parties, and the effectiveness monitoring.
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