ISO 17025 Query Relating to Monitoring of Equipment

[klyoyo]

Hi All,

We are in the early stages of becoming accredited and I have a query relating to monitoring our equipment. For example, our incubators are calibrated and mapped yearly, and the temperature is displayed on the outside panel of the incubator. We are recording the temperature on the display twice daily, am and pm. Is this sufficient, or do we need another thermometer or temperature logger?

Thanks!

 

[dwperron]

Is this sufficient, or do we need another thermometer or temperature logger?

Your organization is the judge as to what is "sufficient" based on the risk to your products and processes.

Personally, I would have trouble with your incubator monitoring. The annual calibration is a token snapshot of performance - it does nothing to tell you how the incubator actually performed over that year. Twice daily logging is a big improvement, but what if someone leaves the door open for a period of time in between those readings? How could that affect your product?

I am a big fan of dataloggers with alarms. They provide an actual record of the incubator temperature, and the alarms alert you when you have a problem.

 

[Seanmhc]

Is this sufficient, or do we need another thermometer or temperature logger?

Your organization is the judge as to what is "sufficient" based on the risk to your products and processes.

Personally, I would have trouble with your incubator monitoring. The annual calibration is a token snapshot of performance - it does nothing to tell you how the incubator actually performed over that year. Twice daily logging is a big improvement, but what if someone leaves the door open for a period of time in between those readings? How could that affect your product?

I am a big fan of dataloggers with alarms. They provide an actual record of the incubator temperature, and the alarms alert you when you have a problem.

I agree with you, dwperron.

I would recommend justifying any risk to product or process due to any failure modes identified that might cause a drop/raise in temperature outside of specification. This should be covered when installing/mapping the equipment for instance, how quickly does the temperature drop once the door has been opened, or if there is a power outage? and how long does it take to ramp back up? Is this accounted for in your incubation timings or any validated process.

A form of temperature monitoring device in your hottest/coolest locations indicating during your mapping process is a good way forward, with the ability to indicate min/max/current temps.

One thing that is also worth noting is the medium in which the items you are incubating are stored in. A temperature logger placed in the incubator will only be insulated by the air around it and itself. If the product you are incubating is in a liquid form, it is good practice to have a logger stored in liquid to monitor changes to this temperature.

 

[VKF1923]

Hi All,

We are in the early stages of becoming accredited and I have a query relating to monitoring our equipment. For example, our incubators are calibrated and mapped yearly, and the temperature is displayed on the outside panel of the incubator. We are recording the temperature on the display twice daily, am and pm. Is this sufficient, or do we need another thermometer or temperature logger?

Thanks!

We were doing this in the lab I work in and it wasn't enough.
What we ended up doing, was buying an Easycloud thermometer. It allows us to monitor incubator temps 24 hours a day, and we print the report once monthly. That seemed to pacify the accreditation board.