In FDA-regulated manufacturing, genuine human errors do occur but they’re cited far more frequently than they probably should be.

In truth, most problems that appear to be caused by human error — especially those that occur multiple times — are actually rooted in processes or systems that when left unchanged, will keep producing the problem despite the convenient band-aids often placed over them.

When human error is identified more frequently than it should be expected to happen, it signals to investigators that problems aren’t being internally investigated thoroughly enough. This can quickly shift the investigator into problem-hunting mode and open your quality management system up to even greater scrutiny.

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Poor or outdated systems for managing documents can pose unnecessarily large risks for medical device companies dealing with an already staggering (and increasingly daunting) number of documents each day.

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