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Section 7.2.2.2., changes to validated methods question.

Discussion in 'ISO 17025 - Calibration and Test Laboratories' started by Tim Casad, Mar 3, 2021.

  1. Tim Casad

    Tim Casad New Member

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    So I recently got into a disagreement with a colleague about what constitutes a change under 7.2.2.2.

    Say for instance, we are following a published validated method (e.g. EPA, FDA, etc.) and the method says we can "tune the instrument as needed" for a certain step, but also gives the settings that were used in the method. If we run the method with different instrument tuning that works better for us, as the method describes we can, does that constitute a change to the validated method?

    My opinion says it doesn't since we're operating within the scope of the method. My colleague says it does because we made changes to the validated method.

    What's your two cents on this?
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    If tuning is permitted, then that's not a change, IMHO. That's part of the method, not a change.