We studied the quality analysis management system and we observed that there were a number of issues the system failed to detect. Let's take a specific example, the robot-operated auto-extraction process. Several laboratory scientists detected problems. These issues were never detected or included in the quality management system. It would be expected that should a concern be raised, a study would be done to determine whether there is indeed a problem, how it should be addressed, and this should be done in a structured manner. It took a long time before they discovered there was a problem with the automated system. On a number of occasions, the automated system failed to detect DNA while the manual extraction system was successful in doing so. That's why we said the system looked good on paper, but that in practice, it didn't work well.
On May 2nd, 2007. See this statement in context.