Free GMP Tips

Free cGMP Tip - Root Cause Analysis

The FDA says, "Human error is not a root cause." If your first reflex is blaming human error, it's time to re-think the situation in order to identify the real root cause of the human error. There are several categories of human errors: slips, lapses, and induced errors. These can account for a large percentage of errors. In order to understand these human errors in more detail, they can be investigated through the use of investigative tools such as a Walk Through Analysis or Control Barrier Analysis. Once the underlying contributing factors and real root cause(s) are understood, then they can be controlled (in many cases).