PDA Letter Article

Human Error Causes OOS Investigation

by Rebecca Stauffer and Madeline Cusick, PDA

Human Error

One Company’s Experience with Determining Root Cause for an Endotoxin Testing Failure

Testing failures are not unheard of in the industry. Routine samples that normally pass specification can, out of the blue, suddenly fail.

More often than not, the laboratory is cited as the cause of the failure. Yet sometimes these testing failures can be the result of a chain of simple human errors that do not even involve the lab at all.