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Capa quality system – more than just corrective action


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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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Capa quality system – more than just corrective action

  1. 1.
  2. 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
  3. 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
  4. 4.  Must exist within the quality program Unforeseen issues are: ◦ Addressed ◦ Remedied ◦ Eliminated ◦ Prevented Vital part of TQM practices to achieve zero defects
  5. 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
  6. 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 y g p gp ◦ Whatever else to stop the defect
  7. 7.  Typical Preventive Actions: ◦ Write a new procedure ◦ Train everyone on it ◦ Documenting the training
  8. 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
  9. 9.  Start with the actions Expected completion dates Champions recorded into database
  10. 10.  Inspectors audit for: ◦ Compliance ◦ Incomplete actions ◦ Incomplete failure analyses ◦ Completed item to verify the claim p y
  11. 11.  The CAPA system is one of the best ways to find, fix, and eliminate defects from the process
  12. 12.