QT103: Corrective & Preventative Action (CA/PA)

Setting Up an Effective Corrective and Preventative Action System

The end result objective of CA/PA is, quite simply, a solution to the issue from which the Corrective Action Request (CAR) was generated. If it is not driving toward a solution, a CAR is a waste of time and resources. For organizations in regulatory environments, the CAPA System is an over-arching umbrella—all control points flow through to the CAPA system.



Learning Objectives

  • The essential components of an effective CA/PA system.
  • Corrective action, remedial action, and preventive action—learn the difference.
  • Understanding the internal & external sources that must feed into the CA/PA system.
  • Flow-charting the CA/PA system.
  • Writing a CA/PA procedure / CA/PA forms.
  • CA/PA System software
  • PICCC Tactic [Problem...Investigate...Comparison...Clues...Cause].
  • CA/PA documentation and verification.
  • Trending and Management Review.
“CA/PA is the HEART of any Effective Quality Management System”


Key Elements of a Sound CA/PA Program

  • Documented procedure.
  • Method for documenting (Form or software).
  • Inputs (data sources).
  • Method for analyzing inputs.
  • Method for prioritizing.
  • Containment.
  • Investigation (determine root cause).
  • Disseminate Information.
  • Identify solutions (corrective or preventive).
  • Verification or validation.
  • Impact assessment (risk analysis), where appropriate.
  • Corrective Action Plan.
  • Implement and Monitor.
  • Effectiveness verification.
  • Management Review.

Who Should Attend?

  • Those with management responsibility to ensure that all nonconformance issues (in cGTPs, these are defined as deviated product) are documented and evaluated.
  • Anyone who is appointed a Management Representative of the Quality System.




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