Have you ever been part of a process that had a failure or two? Perhaps you’ve been on a team that missed a deadline because something didn’t go as expected.  Most of us have. In many cases, the team picks up and carries on towards the finish line.  Although the end result is a completed project, the error(s) within the process remains and is attributed to human error.

Ultimately, if the true root cause is not revealed the likelihood of reoccurrence is still present.  This article delves into why human error is never a root cause, but rather a precipitator for systematic and effective change.

What is human error?

Human error is defined as a problem (e.g., mistake or an inadvertent situation) caused by someone’s actions or influences.  When a problem occurs, it’s easy to stop short and look at the obvious factors.  Like an iceberg, the visible portion of human error is only a small part of the entire picture.  Human error resides at the surface of the problem with most of the underlying contributing factors hidden from view.  It can take some effort to reveal and interrogate the underlying details.  However, the risk of a reoccurrence and the potential for an unsafe product or compromised patient safety outweighs root cause confirmation effort tenfold.

Human Error is the Precipitator for Root Cause Analysis, not Blame - Iceberg TheoryThe Iceberg Theory based on Hemingway’s “principle of the iceberg” can readily be applied to root cause analysis. Only a small percentage of problems are clearly visible/detectable; to find the majority, it is important to evaluate what lies beneath the surface.

Why is reoccurrence a topic of concern?

As consumers, we expect a product to work as indicated.  As a healthcare patient, the expectation for pharmaceutical drugs or medical devices to work safely and effectively is even greater. Life sciences companies understand this expectation. Employees of these companies typically have product quality and/or patient safety included in their job descriptions, goals and their corporate quality vision.

In a regulated industry, the reoccurrence of a problem that impacts product quality and/or the safety of a patient or study subject is cause for alarm.  Having the grit and skills to interrogate the underlying contributing factors to eliminate reoccurrence is the real test of mettle.  If this isn’t done, it’s likely the same problem(s) will surface again. If the problem has the potential to impact product quality or patient safety, the risk of an adverse event or potential harm through the use of the product can increase.  Unaddressed, reoccurrence can yield a citation or two.

Influence on Culture of Quality

Focusing a lot of negative attention on human error places a lot of undue stress on a company’s culture.  The blame game does nothing more than create animosity or even fear within the workforce.  Not only is there a risk to product quality but this can discourage employees from reporting problems that really do need root cause analysis. Further, team dynamics could be put to the test.  In worst-case scenarios, cross-functional teams fail to operate as such, and the silo effect begins to prevail.

World-class quality organizations don’t follow quality standards because it’s a compliance requirement or because someone at the top demands it. They do so proactively with systematic oversight to ensure a persistent culture of quality.  Human errors are investigated to the root cause because the culture empowers people to “speak up” and be the catalyst for productive change.

Not all errors are created equal

Different categories of errors exist, each presenting unique means of error prevention.  Start by categorizing the error. Categorizing human errors help to break down the problem into solvable subsets that can lead to more appropriate solutions.  The focus is all on possible contributing factors to the problem and not people.

Human error is never the conclusion of an investigation, only the starting point.  In fact, it should be considered as a data point within the investigation plan that could trigger an interview to understand the steps leading up to the reported problem.  No one gets up in the morning and decides to intentionally stop production.  No one spends their free time designing means of committing errors.

It takes an alignment of contributing latent failures in the right sequence and at the right time to create the tipping point where an employee has an active failure.  Human error may be the result, but it certainly is not the root cause.

Best practices for handling errors without the blame game

Don’t let a problem sit idle too long.  Investigations that are delayed are risky, expensive and not conducive to a positive quality culture. If possible, go to the scene of the incident. Memories fade so it is important to interview the employees involved as soon as possible. The objective is to learn from the mistake rather than blame an individual or team.

Don’t jump to conclusions!  It is important to not fall into the trap of basing decisions on emotions and assumptions.  It is important to keep an open mind while you are investigating errors.  Remember human nature; in the absence of knowledge, people tend to do what makes sense to them at the time.

You can promote a blame-free environment in your own actions. For example:

  • Focus on the problem: never point the finger at a person or group when discussing, investigating or mitigating errors. People are more apt to be honest, and quickly report errors when they don’t fear culpability. Nobody decides to be intent on doing a bad job.  Encourage those involved to help be part of the solution.  In this type of environment, employees become the best tools in error prevention and will work to look for underlying issues before they can lead to a significant event. If you are involved in a group handling an issue and the discussion turns to blame, lead the team back to the point: the problem.  Blaming wastes time and energy which translates to lost resources.
  • Diagnose before you prescribe: Use your listening ears! Get the entire story so you can build an appropriate investigation plan.
  • Admit your own mistakes: Leading by example is the best way to promote transparency and encourage culture change. When leaders openly admit mistakes, employees take note and will do the same.
  • Praise ownership: Positively acknowledge employees that admit mistakes or pointing out conditions that lead to mistakes.
  • Cultivate and promote transparency: Use communication to encourage ideas and thoughts that can be shared about the reported problem, potential causes, etc. Be open to suggestions and willing to accept all feedback.
  • Promote risk awareness: Employees need to understand how their tasks can impact patients.  When an employee understands the risk of failure in the process and how it can directly impact a patient, engagement in the process increases.  This encourages employees to actively look at the process and point out conditions that pose a risk for failure.


Companies with the lowest error rates also have a blame-free, solution-oriented culture.  Ultimately, culture begins with individuals and becomes assimilated at the group and organizational level.  In addition, an agile problem management solution will help teams to document the process from problem report and categorization (e.g., deviation, non-conformance, etc.), investigation plan and outcome through root cause confirmation.

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