http://qualitymanagementsystem.com/what-is-iso/capa-quality-system-more-than-just-corrective-action/ A CAPA Quality System (CAPA is an acronym for ‘Corrective and Preventive Action’, or ‘Corrective Action, Preventive Action’) is absolutely essential in some format for a complete quality management program. In fact, in at least one quality management system, Good Manufacturing Practices (GMP), it is a requirement and a fundamental tenet of the program. GMP is the quality management system that must be used by pharmaceutical and medical equipment manufacturers to comply with FDA guidelines.

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2.  International Organization for Standardization
 Guidelines on how to document the
processes in specific industries
 The goal:
◦ Consistency
◦ Set of complete, easy to follow instructions
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3.  CAPA is ‘Corrective Action Preventive Action’
Corrective Action, Action
 Essential for a complete quality management
program
 Requirement and a fundamental tenet for
Good Manufacturing Practices (GMP)
 A required part of
ISO compliance
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4.  Must exist within the quality program
 Unforeseen issues are:
◦ Addressed
◦ Remedied
◦ Eliminated
◦ Prevented
 Vital part of TQM practices to achieve zero
defects
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5.  Not difficult to understand or implement
 Not difficult to execute
 Unexpected occurrence will be identified
 Root cause analysis to identify the cause of
defect
d f t
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6.  Action to fix the malfunction or defect
 Can be everything:
◦ Shutting down and inspecting machinery
◦ Issuing a public recall
◦ Retraining all of the production workers
◦ Modifying a computer program
◦ Modifying an operating procedure
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◦ Whatever else to stop the defect
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7.  Typical Preventive Actions:
◦ Write a new procedure
◦ Train everyone on it
◦ Documenting the training
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8.  Formalized process to make sure all of the
corrective and preventive actions were
completed
 Perform as intended
 Assured not to deal with the same issue again
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9.  Start with the actions
 Expected completion dates
 Champions recorded into database
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10.  Inspectors audit for:
◦ Compliance
◦ Incomplete actions
◦ Incomplete failure analyses
◦ Completed item to verify the claim
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11.  The CAPA system is one of the best ways to
find, fix, and eliminate defects from the
process
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