Temperature Mapping on Temperature Control Units.

[PamPierle]

I work in a ISO 17025 laboratory. We recently were audited and discovered we need to do IQ/OQ/PQ's on all our Temperature Controlled Units (TCUs) every two years.

Since our 85 TCU's had already been installed and were in use, I did a IQ/PQ on all of them. I omitted the OQ because we have opted not to do them because they are similar to PQ's and it would be too much to unload and reload all TCU's to do temperature mapping on empty ones. So I only did temperature mapping on full or semi full units.

What is your opinion on this? Are ISO 17025 requirements stringent, or is there some leeway? I have tried to look up the standards, but only got confused. Has anyone else here had to do temperature mapping under ISO 17025?

Bottom line: of course, when we get new units, I will do a full IQ/OQ/PQ, but for existing units I want to do only IQ/PQ every two years. Is this permissible?

Thanks.

 

[dprosvir]

The ideal flow of Validation activities for your TCU’s would be to do IQOQPQ initially upon installation and then develop a program for requalification was a set frequency. Seems like you have covered it in the state “as found” now. You should focus on defining requalification frequency for your TCUs and develop a requalification protocol that can be filled out as a form for any unit that needs a requalification. In addition you need a periodic review program developed with the frequency defined for these units.