What should be done when QA/QC results indicate a potential systemic issue in the lab's process?

What should be done when QA/QC results indicate a potential systemic issue in the lab's process?

• A. Ignore the issue if infrequent.
• B. Halt release and escalate to management without investigation.
• C. Identify root cause and implement corrective actions; re-run affected samples; document the investigation.
• D. Only adjust manual results.

Answer: (C)

When QA/QC indicates a systemic issue, the priority is to address the root of the problem through a formal CAPA process. Start by performing a root cause analysis to understand why the process failed in a systemic way. Then implement corrective actions that target the underlying cause and keep the integrity of the workflow. After those actions are in place, re-run the affected samples to verify that the issue is resolved and no bias or errors persist. Finally, document the investigation, the actions taken, and the verification results so there is a clear record for traceability, audits, and future prevention. This approach prevents recurrence, protects data quality, and demonstrates due diligence. Other approaches fall short because ignoring the issue allows the systemic problem to continue; halting release without investigation leaves the data's integrity unverified; adjusting manual results only masks the problem without fixing the process; and escalating without a formal investigation does not remedy the underlying cause.

When QA/QC indicates a systemic issue, the priority is to address the root of the problem through a formal CAPA process. Start by performing a root cause analysis to understand why the process failed in a systemic way. Then implement corrective actions that target the underlying cause and keep the integrity of the workflow. After those actions are in place, re-run the affected samples to verify that the issue is resolved and no bias or errors persist. Finally, document the investigation, the actions taken, and the verification results so there is a clear record for traceability, audits, and future prevention. This approach prevents recurrence, protects data quality, and demonstrates due diligence.

Other approaches fall short because ignoring the issue allows the systemic problem to continue; halting release without investigation leaves the data's integrity unverified; adjusting manual results only masks the problem without fixing the process; and escalating without a formal investigation does not remedy the underlying cause.