To drive the point home, consider a real-world case study:
A medical clinic in Bucharest faced an ANMDM inspection. The inspector opened the fridge containing RotaTeq vaccine. The digital logger showed errors. The nurse presented a Fisa de Monitorizare. The sheet was perfect—except the pen color changed halfway through. The inspector realized the sheet had been filled out a week in advance (a practice called "backdating" or "dry logging").
The result: The clinic was fined 20,000 RON and lost its operating license for three months. The "harmless" act of pre-filling a log sheet destroyed the business.
If you're creating your own "Fisa Monitorizare Temperatura Frigidere.doc" template: Fisa Monitorizare Temperatura Frigidere.doc
This guide provides a general overview. Depending on your specific needs or regulatory requirements, you might need to adjust the template and procedures accordingly.
You cannot rely on the freezer's built-in digital display alone. Here is why specific sectors depend on the Fisa de Monitorizare:
Temperature Logs:
Actions Taken:
Responsible Personnel:
Frequency of Checks:
A proper “Fisa Monitorizare Temperatura Frigidere” should include:
| Column | Description | |--------|-------------| | Date | DD/MM/YYYY | | Ora (Time) | HH:MM (24h format recommended) | | Temperatura înregistrată (°C) | Actual reading | | Limita inferioară admisă | e.g., +2°C | | Limita superioară admisă | e.g., +8°C | | Conform (Yes/No) | Check if within range | | Semnătura operator | Full signature or initials | | Acțiune corectivă (dacă este cazul) | Description of any action taken |
Tip: Include a footer with Fridge ID, Location, Responsible Person, and Revision Date. To drive the point home, consider a real-world
Pharmacies and hospitals must maintain strict intervals. A fridge storing Insulin or Moderna vaccines must remain between 2°C and 8°C. If the temperature hits 9°C for 10 minutes, the entire batch is compromised. A log sheet provides legal proof that the temperature was checked at 8:00 AM and was correct.