Hi there, my question is simple:
Before performing the OQ of a NEW system, should we calibrate this system’s probes or should we trust the suppliers’ certificates?
Thanks!
Hi there,
I’d like to say trust the supplier, but I would lean on the site of caution and perform your own in-house calibration.
As you will have to perform this calibration at set intervals why not start, before it goes live.
Also whats to say it wasn’t damaged in transit too.
Perhaps this is overkill, maybe other members have a different view.
Regards
I think validation is all about minimizing risk to patient lives.
What IF : the probe is working wrong, due to wrong calibration?
The need is to assume its not working fine and ask the manuacturer to do recalibration at the facility or do own “in- house” calibration or "check " the accuracy of the probe thorugh some kind of testing. Temperature probes can be easily tested thru the kaye validator but if its pressure , then there may be some difficulty.
Worst case will be attaching a copy of the manufacturer’s calibration certificate
OK, guys… thanks for your (fast) answers…
These are in phase with my own first thoughts… I just wanted to be sure
Thanks again
Regards,
Goldo.
Hi,
Use bracketing approach (Post within facility) & rely on Vendor certificates.
Happy Reading !