The most common situation in a cold-chain audit is work done correctly with the evidence scattered. Limit the file to its scope first (which products, sites, vehicles and transport steps) and name the document owners. It has four sections: equipment (identity, maintenance), measurement (device list, verification, calibration), process (cold-chain procedure, cleaning, training) and records (temperature, deviations, corrective actions).
For pharmaceutical cold chains the EU GDP Guidelines call for temperature-monitoring devices used in transport to be calibrated at least once a year.
For a sample shipment, link batch, delivery document, temperature record, device location and customer correspondence in one chain; if there was a deviation, the incident note, review and corrective action belong in that chain. The guidelines also call for retrievable documents, version control, superseded procedures removed from the workplace and archived, and records kept for at least five years.
In an internal drill, pick a shipment at random and see who reaches its records and how fast. Do not imply a missing document exists; log the gap with an owner and a target date.
