From Compliant to Complaint: the human error minefield in the life sciences industry

In particular for the life sciences industry a human error, undetected or unresolved, poses significant risk to the end user of the product.


Nicola Brady tells you how to mitigate risks in the life sciences industry.

To err is human, to forgive divine.  But this forgiveness is not usually forthcoming in industries where a human error can translate into a significant business impact.  Human error imposes significant costs on a business, costs to the quality of the product or service being delivered, financial costs and often reputational costs.

In particular for the life sciences industry a human error, undetected or unresolved, poses significant risk to the end user of the product.  This is why life sciences companies invest so heavily in programs and policies to drive human error down to as low a level as possible. To eliminate it completely is impossible!  Although the world in which we live is moving rapidly towards automation and Artificial Intelligence (AI) technologies, people are still necessary and unfortunately fallible; where there are people there will always be the potential for error.

So, what can a company do to reduce the occurrence
of human error or reduce the impact when it occurs?

  • Allow time for training. Initial training and on-the-job training should be in place and appropriate time should be allocated to allow for training.
  • Put robust processes in place. Having comprehensive policies and procedures in place will ensure standard consistent processes are followed and make errors and deviations more detectable. ‘Error proof’ the process as far as practicable. Complex processes should be risk assessed and mitigation actions implemented as required.
  • Ensure the workplace environment is appropriate for the work required. Consider noise levels, lighting, temperature or other environmental factors that might cause distraction.
  • Document it, investigate it, learn from it. Effective investigation processes should be in place to determine root causes and implement corrective actions. The investigation should not stop when a root cause of ‘human error’ is determined; dig deeper and you might find that there was something else at play.  This will allow you to address the underlying causes that contributed to the human error in the first place and reduce the likelihood of its recurrence.
  • Adopt the right culture. There’s no use for ‘blame culture’.  A quality culture where employees are encouraged to ‘raise their hands’ when mistakes occur actually serves to drive the rate of mistakes down.

If a company applies the right focus and attention on
training, processes, workplace environment, investigations and overall culture
they should find it easy to remain compliant and avoid that complaint!

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Nicola Brady

Nicola Brady

Nicola Brady is a Senior Quality Assurance Specialist with Odyssey VC and Compliant Cloud. She specialises in articles about Quality and Data.

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