The cost of human errors to the manufacturing industry is estimated to be in the $ billions. Recent statistics show that human error is the cause of nearly 80% of failures and deviations in the manufacturing sector. This poses a tremendous challenge to regulated companies as it translates to a significant loss of time, money, and consumer confidence each year, including regulatory enforcement activities.

Global regulators have increased their focus on deviations and root cause analysis (RCA), and this process is one of the largest sources of inspection observations.  Frequently identifying “human error” as a root cause and “retraining” as a CAPA is a clear indication to the regulatory authorities that you’re not solving the problems that exist in your organization.  Worse, it can give regulators the impression that your staff is ill-prepared, error prone, and you don’t have a handle on the real causes of your deviations. Human failure (voluntary and involuntary) is more a symptom than a cause. Current theories see human failures as the symptoms of deeper causes. In other words, human failures are consequences, not causes.

BEC has provided human error reduction expertise support since 2005 to major pharmaceutical, medical device, and food companies located worldwide. Among the services that our company can provide are:

ERROR REDUCTION PROGRAM We can assist you with human reliability experts who can help with procedures and process simplification to reduce human errors and mistakes by:

  • Evaluating your current situation (human error deviations and CAPAs)
  • Investigating the real root causes of the above
  • Suggesting comprehensive, sustainable and affordable actions to minimize the occurrence of human error(s) at your facilities

HUMAN RELIABILITY TRAINING We can help your company to better understand why human errors occur, and this will enable your staff at all levels to move the organization from “error prone” to “error free” resulting in fewer enforcement observations/actions from global regulatory agencies.   We have a comprehensive 3-days certification for quality assurance, production, regulatory affairs, supplier quality and quality control personnel. Participants will learn and practice how to:

  • Investigate error incidents properly
  • Evaluate the CAPA investigation process to identify all the root cause(s)
  • Identify the root causes that lead to human error
  • Identify the controls that could avoid human error


MONITOR BEC can help your company with affordable ways to monitor the effectiveness of your human error reduction program. After implementation of the program, we can independently review your human error deviation and CAPA documents to ensure they are adequate in terms of root cause investigation and appropriate CAPA plans.

Our newest book on this topic will be published by the American Society for Quality in 2018.