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Corrective and Preventive Actions

Michael Pinho

on 16 April 2014

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Transcript of CAPA

After a nonconformity is observed, a system of quality procedures required to eliminate that nonconformity and also to prevent another occurrence of that nonconformity; a CAPA is developed to address and prevent nonconformance.1

When a CAPA is adequately developed it will help to prevent further nonconformities (deviations from occurring). 2

This is done by: 2

Developing a strict basis of investigating nonconformities
Developing a corrective action to prevent a reoccurrence
Developing a method to properly document that the corrective action put in place is indeed effective
CAPA (21 CFR 820.100)
Corrective Action
Corrective Actions are reactive actions that are essentially procedures created to help get rid of the root cause of the nonconformity and to prevent it from happening again. 2
Preventive Actions
Preventive Actions are proactive actions that are essentially procedures created to help diminish the potential cause of the nonconformity and help prevent it from happening again in the future. 2

These actions help to prevent nonconformities or deviations from occurring with the use of previously planned, accepted, and approved actions in place. 2

These actions also help to eliminate the possibility of the reoccurrence of deviations and nonconformities. 2
There are 7 steps to the CAPA Process: 2
Discovery of deviation
Documentation of events
Immediate corrective action
Investigation of the root cause
Casual analysis
Corrective action
Effectiveness of evaluation
Corrective and Preventive Actions
Michael T. Pinho
April 2014
Identify deviation or nonconformity...
Corrective Actions typically occur as soon as possible. 2

Corrective actions are taken on the following: 2
Ways in which deviations are discovered: 2
Audits (Internal or External)
Adverse Events
Product recalls
CAPAs can be issued for any of the following:
Manufacturing deficiencies
Process nonconformities
Observed deviations on any processes within a company
Inadequate procedures which lead to deficiencies
Can be used to correct and prevent nonconformities in any department, facility, and function within a company
1 Tarsio, Joseph F. Corrective and Preventive Actions. Superlative BioSciences Corportation. (2010). http://www.slideshare.net/superlativebio/capa-presentation-3588999.
Accessed 27 March 2013.

2 Rosas, George. Corrective and Preventive Actions (CAPA): Follow Through to Achieve an Effective Quality Management System. Blood Systems, Inc. http://www.aatb.org/files/CAPA%20DEVIATION%20MANAGEMENT%20-%20George%20Rosas.pdf. Accessed 27 March 2013.
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