XRF Analysis - "Worst Case" for an XRF test method?

Afternoon all,

Hope someone can help - we are introducing a hand held XRF analysis device to determine alloy type for incoming & outgoing inspection to ensure we don't get any material mixes. (This is medical device sub-contract manufacture - we use Titanium, Cobalt & Stainless Steel alloys)

I have been instructed to validate this inspection method - I will be conducting attribute GR&Rs - however my boss wants to go down the IQ & OQ method for equipment qualification as well. The IQ is easy enough however the OQ has become a sticking point:

How would you define "worst case" for an XRF test method?

Any help greatly appreciated.

Re: XRF Analysis

I don't know what "IQ" and "OQ" mean in this context. I've been away from using XRF (x-ray fluorescence) for quite a while, (I used XRF plating thickness devices) but I recall that when using them for alloy assaying they were pretty good at identifying consitutents but not so good at measuring proportions--the repeatability wasn't very good. They may have gotten better since then, however.

You say that you want to do attribute studies, but XRF analysis generally results in variables output. If you can explain the abbreviations and what it is you're trying to do you might get better answers.

Re: XRF Analysis

Aplogies - the abbreviations are from medical process validation - IQ - installation Qualification and OQ - Operational qualification.

Essentially OQ stage tests the processe's worst case parameters / settings.

I suppose what I'm getting at is 'what are the extremes i should be testing to check that the XRF device works as intended across the full range'.

Such as:
Would it matter if the alloy composition was high in a particular element? (Does XRF have more issues / variability identifying some elements than others?)

I'm no expert on this inspection method (as you may be able to see already!)

Many thanks,

Re: XRF Analysis

Probably your supplier might be of help

Re: XRF Analysis

Ajit Basrur said:

Probably your supplier might be of help

Click to expand...

Haven't had a response back from them yet