Which item is NOT typically included in a compliant QA/QC program?

Which item is NOT typically included in a compliant QA/QC program?

• A. Documented SOPs, routine internal QC, external proficiency testing.
• B. Calibration/verification schedules.
• C. Incident reporting and corrective actions.
• D. No incident reporting.

Answer: (D)

A compliant QA/QC program in a drug testing lab rests on clear, documented procedures, ongoing internal quality checks, regular instrument calibration and verification, and a formal system to capture, investigate, and correct problems. Documented SOPs provide the standard way tests are run and quality checks performed; routine internal QC—like control samples and run checks—keeps performance within expected limits; calibration/verification schedules ensure instruments stay accurate over time; and incident reporting with corrective actions creates a feedback loop to identify non-conformances, root causes, and preventive measures so issues don’t repeat. The statement that there is no incident reporting runs counter to this approach; without incident reporting, mistakes and deviations aren’t tracked or addressed, so accuracy and compliance can’t be ensured. That’s why it’s not part of a proper QA/QC program.

A compliant QA/QC program in a drug testing lab rests on clear, documented procedures, ongoing internal quality checks, regular instrument calibration and verification, and a formal system to capture, investigate, and correct problems. Documented SOPs provide the standard way tests are run and quality checks performed; routine internal QC—like control samples and run checks—keeps performance within expected limits; calibration/verification schedules ensure instruments stay accurate over time; and incident reporting with corrective actions creates a feedback loop to identify non-conformances, root causes, and preventive measures so issues don’t repeat. The statement that there is no incident reporting runs counter to this approach; without incident reporting, mistakes and deviations aren’t tracked or addressed, so accuracy and compliance can’t be ensured. That’s why it’s not part of a proper QA/QC program.