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