Checklist for pre-/post site inspections

We do not have a checklist, but here are some questions that you can ask:

• How they maintain the refrigerators/cold rooms
• How do they monitor the temperature of the refrigerators / cold rooms
• Are equipment for monitoring temperature calibrated – ask for the certificate of the calibration
• What is the principle of the storage – First in first out (FIFO) or First expire first-out (FEFO)?
• Is there other special conditions for the refrigerators/cold rooms that need to be monitored (for example: is humidity important to be monitored; if refrigerators are used, is it necessary to ensure the conditions of the room in which the refrigerators are located in order to prevent overheating)

For more information regarding storage, please see the following articles:

• Managing medical device infrastructure requirements according to ISO 13485:2016 https://advisera.com/13485academy/blog/2017/06/28/managing-medical-device-infrastructure-requirements-according-to-iso-13485/
• Calibration requirements in ISO 13485 https://advisera.com/13485academy/blog/2019/03/08/calibration-requirements-in-iso-13485/