"Show me the temperatures for this lot" is a question an inspector, an auditor or a customer can ask at any time. A log that holds up answers it with readings taken at the time, by a named person or device, against a stated limit, with a record of what was done when a reading was out of range. A clipboard full of numbers with no actions next to them does not.

What the FDA rules ask for

Two FDA rules most often shape a distributor's temperature records. Which parts apply depends on what you do in your building and on your trucks, and your food safety plan should spell that out. This is a summary, not legal advice.

Sanitary transportation

The FDA's Sanitary Transportation rule covers shippers, loaders, carriers and receivers moving food by road or rail. Businesses with under $500,000 in average annual revenue (adjusted for inflation) are not covered. For food that needs temperature control for safety:

  • The shipper tells the carrier, in writing, the operating temperature for the trip, including pre-cooling if needed.
  • The loader checks that a refrigerated compartment is ready, including pre-cooled, before loading.
  • The receiver checks on arrival that the food was not subjected to significant temperature abuse, for example by taking the food's temperature, noting the trailer's temperature and set point, and checking for off-odors.
  • The carrier, if asked, shows that it held the specified temperature, for example with readings at loading and unloading or time and temperature data from the trip.
  • Anyone who learns of a possible failure of temperature control must keep the food from being sold until a qualified person decides it is safe.

When the shipper, loader, carrier and receiver are all one company, several of these duties can be met through one set of integrated written procedures. Records under this rule are kept for up to 12 months, depending on the record.

Storage of refrigerated packaged food

If your warehouse only stores packaged food that is never opened, the FDA's preventive controls rule sets modified requirements for refrigerated packaged food that needs temperature control (21 CFR 117.206):

  • Set temperature controls, and monitor them often enough to be sure they work.
  • When control is lost, correct the problem, evaluate the affected food, and keep unsafe food out of commerce.
  • Calibrate or accuracy-check your thermometers and recorders, and review the monitoring and corrective action records within seven working days (or a longer, written and justified time).
  • Keep records of monitoring, corrective actions and verification. Monitoring records can be routine readings or exception records that show only when control was lost.

Records under that rule are kept for at least two years. If you repack, cut or otherwise handle open product, your obligations under the preventive controls rule may be broader, and your food safety plan should cover them. Customers and third-party audit schemes can add their own requirements on top.

What a log entry needs

Whether a reading comes from a person with a probe or from a sensor, an entry that holds up has:

  • What: the cooler, freezer, dock or trailer, and the lot or product if it is a product temperature.
  • The reading and its unit, in one unit used consistently.
  • When: date and time, recorded at the time, not filled in later.
  • Who or which device took it, and whether that device is within its calibration check.
  • The limit it is compared against, taken from your supplier specifications and food safety plan.
  • The result: in range or out.
  • The action, if out of range: what was done, who decided, and what happened to the product.
  • The review: who checked the record, and when.

Where to take readings

  • Receiving. Product temperature, trailer set point and reading, and a sensory check, recorded on the receipt so they stay with the lot.
  • Storage. Each refrigerated and frozen zone, on a set schedule or continuously.
  • Staging and loading. How long product sits out of refrigeration, and a check that the trailer is pre-cooled before loading.
  • In transit and at delivery. The operating temperature given to the carrier in writing, and readings or logger data at loading and unloading. Our article on temperature capture at every stop covers the delivery side.

Manual rounds or sensors

Manual rounds cost little and need no new equipment, but they leave gaps between rounds and depend on people remembering. Sensors read continuously and can alarm out of hours, but they cost money, still need accuracy checks, and keep their data in the vendor's portal unless you bring it out. Either way, the rules above care about the same things: monitoring often enough, acting on deviations, checking instruments and reviewing records.

Tie readings to lots

The weakness to look for first is temperature data in one place and lot tracking in another. At audit time someone joins them by hand, by date and zone. Make that join easy:

  • Record receiving temperatures on the receipt, so they belong to the lot from the start.
  • Know which zone each lot was in, and when, so a storage reading can be matched to the lots that were there.
  • When a reading is out of range, list the affected lots in the corrective action, and hold them so they cannot be picked until someone qualified decides.

Those lot records are also what a recall needs. Our recall mock drill is a good way to test them.

Where APFoodz fits

APFoodz tracks lots, expiry and quarantine, so a lot with a temperature problem can be quarantined while someone decides, and each lot's events show where it went if it has already shipped.