External calibration/Qualification frequency?

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(reposted from gas chromatography forum since I have not received any response there)

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
markf wrote:
(reposted from gas chromatography forum since I have not received any response there)

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


I have several GC and GC/MS methods accredited to ISO 17025 and i never, ever call external technicians for routine maintenance and rarely for extraordinary maintenance/failure, but it happens only if i cannot do it by myself.
Do you have a system suitability/maintenance procedure for your instruments?
You can write it up according to your experience and to valid sources, for example the maintenance schedule suggested by the producer of your instruments.

As long as the instrument can be calibrated, tuned, results are accurated (for example analysis of an interlaboratory comparison or reference material) and meets or exceeds the method requirement why would you need external service? It's just a loss of money.
I'm talking about GC and GC/MS...they are usually easy to maintain.

You can schedule for example: gold seal and liner check/change (maybe using DDT or Endrin breakdown), number of theoretical plates of your column, change in the slope of your calibration curve, change of pumps oil/oring, cleaning of ion source/detector, check/change of gas filters, leak check, etc.
Davide Balbo from Italy
markf wrote:
...Take in account that our analysis is ISO/IEC 17025 Accredited, is there any requirement in this standard regarding maintainance intervals?
...

Mark, I was reluctant to write, but when you work in 17025 accredited lab you should read that standard :-)
I have several GC and GC/MS methods accredited to ISO 17025 and i never, ever call external technicians for routine maintenance and rarely for extraordinary maintenance/failure, but it happens only if i cannot do it by myself.
Do you have a system suitability/maintenance procedure for your instruments?
You can write it up according to your experience and to valid sources, for example the maintenance schedule suggested by the producer of your instruments.

As long as the instrument can be calibrated, tuned, results are accurated (for example analysis of an interlaboratory comparison or reference material) and meets or exceeds the method requirement why would you need external service? It's just a loss of money.
I'm talking about GC and GC/MS...they are usually easy to maintain.

You can schedule for example: gold seal and liner check/change (maybe using DDT or Endrin breakdown), number of theoretical plates of your column, change in the slope of your calibration curve, change of pumps oil/oring, cleaning of ion source/detector, check/change of gas filters, leak check, etc.


That´s preventive maintenance, and must be wrote. The reason of preventive maintenance and OQ/PV is to ensure your instrument is not going to fail during analysis from period to period. Perhaps you can do PM less than one year, depending on your instrument history and use. This tools are for you, not for auditors. Users are the ones who knows instrument better. The frequency depends on you. does your instrument broke easily? Do you use it all the time? Take time and do evaluation, may be you can do it in a frequency of two years.
My experience is most HPLC. I had to change on UHPLC from one year to twice a year, because pump seals started to fail and got leaks. So, I wrote it in a SOP, that for UHPLCs, we will do full PM anually but after six months a reduced PM and change only parts we know we have to.
Q. F. Ignacio Viera
We use a service contract for preventative maintenance by the manufacturer once a year to ensure performance for the next year. Our UKAS auditors usually ask to see this on their annual visit.

General in house maintenance is performed once a week (solvent wash bottle change, syringe if needed, septum liner). Cutting/baking of the column and cleaning of the ion source when needed but once a month at least if not otherwise done.

Using both in house and external quality controls allows us to monitor any issues we have and identify any trends that occur.
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