1. Human error
One might simply forget to check the temperature or record the data incorrectly.
2. The refrigeration temp log only covers working hours
A further problem might arise if the SOP requires that the fridge temperatures are checked twice, at the start and the end of the working day. The risk here is that the temperatures might be satisfactory in the evening but incorrect by the morning.
In the event of a temperature excursion, there is no way of knowing when the problem occurred or how long the refrigerator has been in alarm.
Naturally, most pharmaceutical facilities have a policy of assuming the worst and therefore discard the products stored in that refrigerator. Such an event can negatively affect a pharmacy's reputation, and result in significant financial loss.
Even more serious is the risk of medications or vaccines no longer being effective because they have deteriorated when not stored at the correct temperature.
3. Errors in data storage
When refrigeration temp records are written by hand and transferred to storage manually, or even if it is manually transferred to a LIMS data management system, there is always a risk of data being altered or omitted.