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nonconforming materials report

What to do about Human Error Deviations?

For many years life science companies have a large percentage of root cause analysis end with a conclusion of human error- estimates state anywhere between 30-70% throughout industry. While this may meet the exercise for closing an investigation, these types of conclusions don’t lead to value-added CAPA’s and in many cases, could cause more harm than good. Because of this there is a noticeable movement in the industry to try to get away from Human Error root cause conclusions. While this is admirable, it seems many organizations lack direction around this directive. This white paper will attempt to provide some direction around the goal of reducing human error by examining some of the reasons we settle for human error conclusions, and some of the ways we can avoid human error as a conclusion.

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