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"If It's Failing, Just Change the Specs"

This story reminded me of an experience calibrating pipettes: Former Theranos Lab Employee Interview   My first job in validation was mostly qualifying CTUs and laboratory equipment.  I had four years of GMP lab experience at this point.  I was used to pre-approved acceptance criteria and protocols and writing deviations for changes to such.  This validation company I was working for mostly did biotech and R&D validation, so non-GMP.  Most clients didn't even see the protocol until it was sent to them for final post-approval. My boss had an ongoing client that mostly had CTUs to qualify.  It was a laboratory doing HIV research.  They needed pipettes calibrated and my boss said we could do it even though I don't think he had any experience doing it.   So my boss bought a balance and some pipette calibration tracking software.  The catch was that since these pipettes were used in a BSL-2, they didn't want to have to decontaminate ...