Root Cause Analysis and Human Factors

Root Cause Analysis and Human Factors

Mark Crawford

In its new white paper, “How to Reduce Human Error by Managing Human Factors,” the FDA indicates the “typical response to a human error is retraining. But studies have now shown that training —or lack thereof—is responsible for only about 10 percent of the human errors that occur. Despite [an increased] awareness of human errors, companies still frequently fail to substantively and correctly address errors.”

Companies often turn to training, or retraining, as a quick and easy solution for a human error, when the real cause may be a deeper, systemic issue that could be revealed through root cause analysis (RCA).

“Training is thrown at problems when it is not even known what the real problem is—or the root cause of the problem,” says the FDA. In fact, “instead of helping, retraining can sometimes make a bad situation worse.”

George Bernstein, a root cause analysis expert with MAI Consulting ( in North Carolina, indicates the most common root cause for a human error is not following procedure and the most common corrective action is retraining.

“While this may in fact be the root cause,” he cautions, “if the problem has been repeated numerous times within the past year or so with the same person, the problem may be ineffective training. If the problem is a repeat with a number of people, the problem may be inadequate instructions. Trending of deviations is essential to verify that the root cause was correctly identified.”

The FDA warns that quality control staff should be wary about listing “retraining” as a corrective action in an FDA investigation unless they are absolutely certain that is the case. “By indicating that retraining is being done to correct a problem, they are also pointing out the fact that the original training effort was less than effective,” writes the FDA (which may not actually be true).

Root cause analysis, when properly implemented, is a comprehensive method of investigation that identifies the sequence of events that resulted in an adverse incident or a human error. Different human error categories are:

  • Procedure-related errors
  • Human factor engineering related error
  • Training-related error
  • Error reduction
  • Supervision-related error
  • Communications-related error
  • Individual error

At first glance the cause of a human error may seem obvious, followed then by the hasty conclusion that training or retraining can fix it. However, a complete human error root cause analysis investigation often reveals a much deeper issue is to blame.

“If only the top levels of an event (human error or equipment failure) are investigated, only one problem will be solved,” says the FDA

“Unfortunately, some RCA methods fail to dig far enough. Often, organizations will get down to the management-systems level and stop at that point, primarily because corrective actions and recommendations must be actionable and measurable, which may be more difficult to do at the organizational cultural level.”

Bernstein points out that, as an investigator, it is impossible to be an expert in every area and process. “Identify the subject matter expert, or better, the “go-to person” who knows what really goes on and is willing to explain it to you,” he says.

If you feel the need to sharpen your RCA skills, take a seminar or consult online sources such as the Society of Manufacturing Engineers’ “Improve Your Root Cause Analysis” and’s “Root Cause Analysis Knowledge Base.”

“Using peer review is an effective process,” adds Bernstein, “especially if the group of investigators is relatively inexperienced. This gives the investigator insight into detail that may have been missed in the investigation/analysis, and also gives the reviewers an opportunity to learn from each other in a collegial manner.”

Pilgrim Quality Solutions

Pilgrim pioneered quality management software more than 25 years ago for regulated enterprises that needed a better way to deliver, track and oversee quality-related activities.