External calibration/Qualification frequency?

Discussions about GC and other "gas phase" separation techniques.

4 posts Page 1 of 1
Hey guys, I have a question, I was not even sure that it's on topic since it's not about the actual chromatography process, so I'd it's in the wrong section feel free to move it.

We traditionally call the external service technicians once a year for maintainance and operational qualification of our equipment, GC, detectors autosamplers etc'.
I personally see it as a good practice in general and good preventative maintenance for sensitive lab equipment in particular.
Now a higher-up manager wants to know if this is absolutely necessary, and I, seriously, don't know an answer to that question.
Is there any manual that specifically states when external maintainance/OQ should take place?
Take in account that our analysis is ISO/IEC 17025 Accredited, is there any requirement in this standard regarding maintainance intervals?

Thanks in advance,
Mark
Hi MarkF,

Sure, this is on-topic! When I worked in a ISO 17025-accredited lab, we wrote that we would perform one PM AND one PQ/PV per year on all of our instruments across the board and stuck to this schedule.

Ask your manager what price there is to have data back to your customers late and/or inaccurate...yes, PMs and PQs are necessary, especially in a regulated environment. Does your firm have an SOP stating that PQs will be performed with a given frequency? If so, just stick to it...auditors love low-hanging fruit, and you (and you manager) should feel better about the whole thing.

To my knowledge, no, there is no guidance regarding the frequency of PMs/PQs, most often I've seen is Quarterly (most), least often is Once Annually. Guess that this depends on the organization's tolerance for error and instrument use.

Best Wishes Mark!
MattM
I don't know about normal ISO but if you are involved in anything related to FDA then I am pretty sure it is an annual requirement.

I wish I worked somewhere that I only had to worry about it on an annual basis, with our environmental samples we have to do some kind of maintenance daily to keep the instruments clean and in calibration.
The past is there to guide us into the future, not to dwell in.
Mark,
Based upon your question, I'm guessing you work in a gas processing plant, refinery, chemical plant etc. and your GCs are automated process analyzers. If this is the case and you're still looking for some information, send me your email address or call (918) 662-7000 & ask for GreGG.

Disclaimer - I am an analytical sales guy for Siemens. The information is free of charge...however, I'll need 5 hours of your time for a timeshare-like interview before handing over the goods. Have you ever visited a used car dealership? You know how those sales guys come rushing out of the building like a kicked over pile of fire ants? The encounter will be sump'n like that.

ONLY KIDDING - Call, email address, response with the thing & I'm out.
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