What Caused the Temperature Excursion?
Separate containment, evidence, causal findings and authorised disposition; preserve competing hypotheses; and propose CAPA effectiveness checks without giving regulatory or legal advice.
36 minutes
Scenario
A medical-device distributor has quarantined four temperature-sensitive shipments after conflicting logger readings. No patient harm is reported. Operations wants to release the goods using stability data, while quality says the investigation cannot determine product disposition. The team must preserve evidence and follow the governing quality process.
- Your role
- Quality systems investigation lead
- Method
- Root Cause Analysis
Evidence pack
Carrier logger
All four shipments recorded 8.4–9.1°C for 18–46 minutes near Dock B.
Package sensor
Three packages stayed at or below 7.8°C. The fourth has a 20-minute data gap that overlaps the carrier excursion.
Dwell
Staging dwell was 32–58 minutes. The local procedure says 30 minutes, but the dispatch dashboard clock starts at scan rather than physical staging.
Dock control
A door-position alarm failed intermittently on two of the four shipment days; maintenance closed the ticket as 'unable to reproduce.'
Firmware
Carrier logger firmware changed two weeks earlier from one-minute to ten-minute sampling; the approved qualification record still references one-minute sampling.
Calibration
Both logger types were within calibration. A bench comparison has not yet been run under changing ambient temperature.
Stability
Internal stability data include exposure up to 10°C for two hours, but the labelled storage condition remains 2–8°C.
People
Training is current. Staff say physical staging often begins 10–20 minutes before the dashboard scan.
Scope
No comparable excursion appears at Docks A or C, but those docks use a different door-control model and carrier route.
Constraints
- Quarantine, evidence preservation and the governing quality process take precedence.
- The learning case does not determine release, reportability or legal responsibility.
- Conflicting measurements must remain explicit until a qualified comparison resolves them.
- Training cannot be selected as a cause without a mechanism supported by evidence.
Case steps
Work through each prompt using the evidence pack. Answers and rubric weights stay protected in the interactive flow.
Define immediate containment and evidence-preservation actions. State which decisions remain with qualified quality, safety or regulatory authorities.
Construct a timeline that distinguishes physical staging, dashboard time, carrier readings and package readings. Mark verified, inferred and unknown intervals.
Build at least three causal hypotheses covering exposure control, time-recording design and measurement behaviour. Define evidence that could support or reject each.
Draft current findings and limitations. Separate verified non-conformances, plausible causal factors, unknown product exposure and questions outside the RCA team's authority.
Propose cause-linked corrective and preventive actions with implementation checks, outcome measures, owners and review periods. Include one balancing measure.