7 replies to this topic

[shookimogh]

Hello everyone,

 

We had been audited against FSSC22000 and the auditor has asked for " missing the external maintenance evidence of the temperature monitoring system" . 

That is against our freezers and coolers monitoring which is being done by data loggers and monitoring software . she mentioned we must have a preventative maintenance plan for this software.

Has anyone a similar experience ? or a template or SOP of what we need to do?

 

Thank you in advance!

[Scotty_SQF]

When I worked for a company that had these, we used to send them out once year to be checked and calibrated.  Could this be what the auditor means?  They should send you spare ones to use until yours is checked and calibrated.

[Scampi]

The thermometers still need annual calibration against a master, so either send them out, have the company come in OR purchase a master thermometer that it calibrated annually and you verify the cooler temps against that

 

FYI-CFIA also requires this

[G M]

Calibration records is how I would interpret "external maintenance evidence" as well.

[shookimogh]

@Scampi: Thanks for your advise. that's what we are doing. we have a master thermometer and we are monitoring monthly as a verification plan . but she didnt accept this! she was talking about a pm plan for these.

[Scampi]

what does your program say you will do if you find a thermometer outside of your allowable variance?

 

 

I think she's out of bounds on this one

Edited by Scampi, 26 February 2024 - 05:29 PM.

[jfrey123]

If the auditor is calling out the software specifically, perhaps you need to write into the SOP that the software used to monitor temps is kept updated (firmware updates and whatnot I guess?).  If you're using an online portal for the monitoring through the company that owns it, asking them about maintenance to the portal could be something you keep filed to show they're handling such maintenance on their own.

 

This reminds me of a customer audit I had at a dry steam sterilization plant:  they sent two gals to audit our tiny operation who seemed more excited to be partying in our city vs auditing us, but they came from a medical auditing background.  They had a lot of objections we had to cover being a basic sterilization operation, but we ran into trouble with them when we told them time and temp is our preventative control for the log reduction in treated goods.  They asked me to prove the clock that times our treatments was validated, and it legitimately was one of the first times in an audit for that company that I was dumbfounded... 

 

"How do you know the program ran the treatment for 20 minutes at this temperature?"

"Um....Because the computer says so?"

"How do you verify the time recorded by the computer is accurate?"

*me and the CEO nervously shrugging at each other*

"Because it's a windows machine and Bill Gates says the clock works.....?"

 

They dropped it after that because we showed we purposely overrun the times specified in our validation studies by a fair margin, but asking me how I validate the clock on a desktop computer is accurate seemed like something that really applies to the medical field vs that small outfit I used to be with lol.

[shookimogh]

Thanks to all of you. I think she asked for the calibration first and cause we had not take the calibration, she asked for external evidences. I asked the sensor company they advised with tracible calibration. The company is resisting because we have 13 of these sensors and it costs them a lot. But at the end they have to take action. 

 

Thanks for your help