Cardinal Health

Quality Oversight & Risk Management Support

Supported Cardinal Health in managing deviation and CAPA processes, resolving non-conformances, and driving post-market risk assessments—ensuring quality oversight across production and regulatory functions.
HOW WE HELPED
  • Oversaw deviation management and CAPA processes with timely closure and effectiveness checks.
  • Managed non-conforming quality issues in cross-functional collaboration.
  • Participated in Material Review Board decisions on non-conformances.
  • Assessed and advised on product holds as needed.
  • Reviewed inspection criteria, sampling plans, and Change Orders.
  • Led post-market risk assessments, escalating critical issues to the Risk Management Board.

Processes

Deviation, CAPA, Risk management process

Cross-Functional Teams Engaged

Yes

Risk Escalations Conducted

To RMC Board

Post-Market Oversight

Implemented
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