Case Studies

Real quality problems, worked through step by step: what happened, which tools fit, what the evidence proved, and what it didn’t.

CAPA · Calibration · QC Lab

Pipette OOS: When Two Things Change at Once

Recurring as-found OOS results after a switch in both pipette manufacturer and calibration lab. How Change Analysis and Is / Is-Not framed the problem, why the causes were confounded, and the experiment that would separate them.

Details in each case are anonymized. More case studies are in development.

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