The Enterey Blog

Reframing Human Error

Posted by Tita Tavares on Wed, Jun 24, 2015 @ 11:09 AM

From the CEO

Has your company experienced any negative consequences due to human error? 
Statistics indicate that human error remains a major cause of failures in pharmaceutical, biotech, and medical device manufacturing facilities, despite increasing automation.

The consequences of these failures are many, including:

  • Potentially fatal patient safety issues
  • Costly production issues, including batch failures, product recalls, supplemental quality testing, and increased employee training
  • Expensive penalties and even criminal charges due to regulatory noncompliance
  • Damage to brand image, reputation, and consumer confidence

The typical response to human error is counselling or re-training; however, at Enterey we have found that neither of these actions succeeds in adequately preventing recurrences, because human error is NOT the final root cause of the majority of manufacturing deviations. The truth is, in most cases, issues identified as “human error” are influenced by a systemic problem¾not just a human problem.

In this issue, Enterey consultant Cindy LeBeau discusses a better approach to combatting the issue of human error. She’ll also review a case study that demonstrates how she and her client team were able to help a drug substance manufacturer dramatically reduce manufacturing deviations that were originally attributed to human error.

If you have issues surrounding manufacturing deviations that you believe are due to human error, call me at 800-691-2349. We might just be able to help your organization reduce its human error-related issues.

Mike Ferletic, CEO


The Retraining Reality

Shifting the mindset is more effective than retraining in preventing human-error recurrence
By Cindy LeBeau, Senior Consultant 

Human error has become a hot topic in pharmaceuticals.  Companies are spending hundreds of millions of dollars each year due to human error related discrepancies. According to a survey of BioPhorum member companies, more than 50% of manufacturing deviations are attributed to human error[1]. The most common corrective action set is to retrain the people involved; however, according to the same study, this approach does not sufficiently eliminate the problem, and the errors are repeated 47% of the time.


Retraining employees is often ineffective for eliminating manufacturing deviations because in most cases, human error is NOT the true root cause of the issue.

Why do human errors occur?

People are the apparent cause of a number of manufacturing deviations due to: acts of omission; memory lapses, slips and trips; distractions in the workplace; and incorrect decision making. At Enterey, we believe that, more often than not, there is a deeper root cause of human errors, which can be attributed to the following non-human, or systemic, issues:

  • Process: Process issues arise due to such challenges as complex or poorly designed SOPs, lack of system safeguards, and procedural variability.
  • Technology: Technology issues arise from non-robust systems and/or insufficient or poorly performing equipment.
  • Work Environment: Examples of work environment issues include interruptions and distractions in the workplace, insufficient resources to perform the procedure accurately, and/or employees carrying too large a workload.
  • Culture: A culture that emphasizes finger-pointing and does not make problem-solving the main priority is doomed to experience the same issues over and over again.


A Better Answer to Human-Error Prevention

Due to the high number of recurring human-related errors, regulatory agencies are pushing for a more formal approach to human error reduction. At Enterey, we have found that the following three changes can have a significant effect on the recurrence rate of manufacturing deviations.

  • Determine the TRUE root cause. We’ve helped clients to train operations staff members to perform deep root-cause analyses, evaluate frequency vs. severity, and recommend more impactful corrective actions. These operations people then clearly communicate the results of the assessment to the quality team.
  • Shift the mindset. Most employees have no desire to make errors that could potentially endanger human life or damage their employer’s reputation. The team performing deep root-cause analyses should always maintain the assumption that manufacturing deviation is more likely the result of a systemic issue than true human error. In fact, more often than not, there are multiple causes for a deviation.
  • Increase positive communication and reinforcement. Recognize and even reward employees who have made a difference by helping to resolve manufacturing deviations. Set organization improvement goals and reward the entire organization when these goals are achieved. 

When a company is less inclined to point fingers and more inclined to find the true root cause of an issue, employees generally become more proactive in revealing key information when root-cause assessments are performed. Creating a system that rewards employees for reducing manufacturing deviation can galvanize an entire organization toward a culture of continuous improvement.


Click Here to Read Our Current Human Error Project Brief 
Published by Enterey Communications Team

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