This control plane turns synthetic diagnostics QC exports into one review surface: evidence continuity, stale calibration artifacts, assay variance, telemetry replay, and release-packet completeness before result publication.
| Risk | Owner | Subject | Observed state |
|---|---|---|---|
| high Evidence |
Lab QA | Specimen chain-of-custody packet | One batch is missing signed custody evidence after a handoff between intake and assay verification. |
| high Calibration |
Diagnostics Operations | PCR-07 calibration file | The current run depends on a stale calibration artifact outside the approved review window. |
| high Review |
Clinical Quality | Quarterly assay QC review | The latest review packet is incomplete and release sign-off is still pending. |
| medium Telemetry |
Lab QA | LIMS export continuity | Two export windows are missing from the evidence trail, weakening audit continuity. |
| medium Variance |
Clinical Quality | Reagent lot variance | A reagent lot drifted beyond the expected range and needs secondary validation. |
| high Release |
Clinical Quality | Assay release packet | The release packet is missing one reviewer attestation and one supporting evidence link. |