Ensure Compliance through Effective Root Cause Analysis under FDA’s CAPA Norms

An error can be defined as an action planned but not executed according to the plan. Research by Dr. James Reasons of the University of Manchester in England found that humans commit an average of 6 errors per week. With all the error that are occurring and all the ways that we could destroy our selves, life is still preserved. Why? It is because humans have the ability to sense change and break the error chain.

 

The main causes of human errors are:

  • Lack of Communication
  • Complacency
  • Lack of Knowledge
  • Distractions
  • Lack of Teamwork
  • Stress and Fatigue
  • Lack of Resources
  • Pressure
  • Lack of Assertiveness
  • Lack of Awareness

 

When considering the interaction of people and machines, human errors can be classified into 4 categories:

  • ANTHROPOMETRIC FACTORS
  • HUMAN SENSORY FACTORS
  • PHSIOLOGICAL FACTORS
  • PSHYCHOLOGICAL FACTORS

 

Not all human errors are necessarily the fault of the person who made the error. In many cases, the error is either forced by external circumstances or by obsolete rules. So if blame is to be allocated for any error, care must be taken to identify the real root cause of the problem.

To this end, AudioEducator, the country’s leading source of information and training for pharma industry professionals, has created a webinar titled “Effective Root Cause Analysis for a Compliant QMS” with expert speaker Ajit Basrur. This session is a fruit of extensive research and brings out revolutionary solutions for the pharmaceutical industry.

 

 

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