Cold-Chain Temperature Excursion (Vaccine Depot)

flowchart TD
  A[Data logger alarms - 2 to 8 C envelope breached] --> B[Quarantine the pallet, do not discard]
  B --> C[Download the full logger trace, not just the alarm point]
  C --> D{Which direction was the breach?}
  D -->|Above 8 C| E[Sum cumulative time above 8 C across the whole cold-chain life]
  D -->|Below 2 C| F[Check the freeze indicator and the shake test where applicable]
  E --> G{Inside the manufacturer stability budget?}
  F --> G
  G -->|Yes| H[Release with a documented deviation]
  G -->|No| I[Refer to the responsible person]
  I --> J{Concession possible on stability data?}
  J -->|Yes| H
  J -->|No| K[Destroy under witness and notify the regulator if a shortage results]
  H --> L[Close the deviation and trend the failure mode monthly]
  K --> L
  L --> M[Requalify the route or the packout if the mode repeats]