hi

I have few queries related to calibration


1) Is calibration is necessary/required for new Equipment

2) how to define Calibration Frequency

Hi,

It really depends in what industry you are working. If it is medical devices or pharma then you probably need to validate the accuracy of the device before you begin.

If you are in a university lab then it is unlikely this will be required.

As far as calibration interval, I would initially follow the manufacturer's recommendation then after the first year or so you can extend the interval if the instrument has been reliable.

This does of course depend on what the instrument is used for! If it is used regularly or takes alot of punishment then you should calibrate it more frequently!

Hope that helps!

JCVP

Hi JCVP

Thanks for inputs , our company is going for AS9100 certification , initial documentation audit is over , next audit scheduled for system audit

Thanks for information


Hi,

It really depends in what industry you are working. If it is medical devices or pharma then you probably need to validate the accuracy of the device before you begin.

If you are in a university lab then it is unlikely this will be required.

As far as calibration interval, I would initially follow the manufacturer's recommendation then after the first year or so you can extend the interval if the instrument has been reliable.

This does of course depend on what the instrument is used for! If it is used regularly or takes alot of punishment then you should calibrate it more frequently!

Hope that helps!

JCVP

JCVP has given very good response.

Btw, if you need info on any of your equipment, pl feel free to mention here :D

You cannot assume new equipment 'straight out of the box' is calibrated. Unless it comes with a certificate of calibration.

Dear Janeb

Thanks for your inputs very useful and the AS audit was successful

regards

ramesh

That's good to hear, Ramesh. Well done. :applause:

JVPC1969 gives a good answer. Here is my 5c. I am in the FMCG industry.
My philosophy on determining frequency is that we must prove that we are in control of our technology. We need to determine what calibration frequencies are - based on usage, environment, competence of users, and purpose of result generated etc.

New equipment: I agree that it can’t be assumed that equipment if fit-for purpose straight out of the box. We carry out a short verification on any element that has an effect on a result and have changed. This includes (but not limited to) new equipment, new chemical supplier, new analyst, new location etc.

For chromatography this verification would include –
Determine our needs. Based on this, determine
linearity range by injecting a minimum of 10 standards in triplicate. Repeatability (r) by analysing a minimum of 6 replicates and determining SD(r)Reproducibility (R) by analysing reference material and giving it the statistical treatment. (We are in the fortunate position of having access to large volumes of certified reference materials.)
If all the results meet our predefined requirements, verification is successful.

Zamclachia, excellent post there. Thanks for the information.

IMHO, calibration frequency is a parameter to be managed, not dictated.

The optimal calibration frequency is an Art; one requiring intuition, correct data to be analyzed (as you included), and a general understanding of what the purpose is for a calibration interval, and an understanding of the equipment in the program.

There is a pretty large sweet spot in the middle to be in. Being on the extremes (too often; not often enough) is where problems start creeping in. :agree1: