CLPEX Chat Board

I’ve heard that once agencies are accredited under ISO 17025 then they can’t use new methods of processing until they are internally validated (but they can use methods currently in their SOP’s). I’m curious about commercially available products like Wetwop or Wetprint. Does every agency have to do their own internal validation prior to using these products? Is it possible that agencies really only have to do a performance check and not a full blown validation study?

How about other methods that aren't in your SOP's (perhaps Acid Yellow 7), is it required to conduct a validation study prior to using it?

Michele

Hey Michele,

I asked about this recently as it came up in our lab and the answer was yes - you have to validate every time if it isn't in your sop. If you hear different let me know though...

Michelle,

I agree with Kevin's posting. Recently, we wanted to add two new blood reagents to our processing reagents (Phloxine B and Acid Yellow 7), and we had to perform an in-house validation study on both techniques to show their uses/benefits/methods before the official SOP was written. Following the testing and SOP review/approval by the laboratory QA system, the techniques were approved for use in casework. Prior to the offical approval, they could be used, but a deviation from procedure had to be filed by lab supervision explaing why the technique was used, etc. as a part of the case file.

Andy

I think it depends on how your laboratory quality manual is written. I have worked at a couple ASCLD/ISO labs and the procedures were pretty much the same.

On a case by case situation you would need (like Andy mentioned) a Deviation from the Method.
For example if you wanted to process a bloody object with amido black, but the object was painted and your Analytical Method only had a methanol based formula. To use an aqueous based amido black you would need to find an accepted formula and procedure and get written approval from your technical supervisor. All of that would need to go in your case file.

Our quality manual allows for substituting a lab prepared reagent with a commercially available reagent as long as it is a reagent we use. So instead of making PD we could purchase commercially available PD and we are within our guidelines.

For a completely new reagent the validation process depends on the uniqueness of the process. Our QM states it as follows:
The extent and depth of validation studies shall be consistent with the novelty of the proposed analytical method.
• Standard methods (published/validated standard methods) require a performance check to demonstrate the method works in our lab environment.
• Non-standard methods (methods and techniques that are widely accepted in the science community that are being adopted by the Laboratory) require demonstration that the method or technique is accurate and reliable when performed by trained personnel.
• Laboratory-developed methods (novel methods developed independently by Laboratory) would require extensive validation.


It is really all about how you set it up in your Quality Manual. That is why it is important to have a nice balance in your manual about being specific…but not too specific. There is no sense in reinventing the wheel, if someone already did an extensive validation study you should really only need to show that it works in your lab and you know how to do it.
PG