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www.fdanews.com/articles/123702-expert-targeted-best-practices-reduce-human-error-in-plants

Expert: Targeted Best Practices Reduce Human Error in Plants

January 15, 2010
GMP regulations require that production errors be fully investigated, but when companies identify human error as the cause of an incident, they tend to see that as the end of an investigation rather than a starting point for further review, experts say.

Eighty percent of product failures are due to human error and of those, more than 50 percent are related to procedures, Ginette Collazo, an expert on industrial and organizational psychology, told drugmakers during a recent FDAnews webinar.

About 10 percent of product failures are related to a lack of training or knowledge, and less than 10 percent are caused by an individual employee simply making a mistake, she said.
Drug GMP Report