HUMAN ERROR
Human Error and the Pharmaceutical Industry
- Behavioural GMP -Human Error analysis. Employee change behaviour programs to meet business strategies and compliance targets.
Purpose
- Behavioural GMP Module - The Purpose of this Module is to reduce human error by altering behaviour of the employees engaged in GMP activities.
Human Error-Impact
- Impact of human error in the Pharmaceuticals industry can be severe and can cause deviations, customer complaints, batch rejects, products recall and regulatory deficiency. The error can lead to reduced quality, injury, property damage, environmental damage, or even loss of life. The biggest threat is consumer safety. The product defects may include the lack of purity and potency. Defective product has been related to many injuries.
Consumer Safety
- To protect consumer safety and to deliver high quality products the Pharmaceutical industry needs to analyse and control risk of human error, as any other risk. To better understand which errors may lead to serious adverse outcomes, the risk needs to be assessed and appropriately addressed.
Regulatory Agencies
- The Regulatory Agencies (TGA, FDA, etc.) expect organisations to prevent human error from happening. The severity and frequency of the human error must be reduced. Organisation need to investigate the relationship between organisational culture, employee behaviour and human error. GMP deficiency is often a symptom of the quality system failure.
Workplace Culture
- The Workplace culture is critical for an organisations success and employee satisfaction. The workplace culture is made up of employee beliefs, values, unwritten rule, and employee behaviour. The employee morale and satisfaction will influence employee behaviour. The employee behaviour at work is an indicator of employee attitude, beliefs, perception, and motivation. The employee behaviour may impact on GMP compliance, quality and productivity, safety and employee retention. The unsafe behaviour of one employee can influence other employee behaviour.
Consequences
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The batch rejection, product recalls, fines, product seizure, organisation and personal liability and criminal prosecution as a result of not following procedures and not meeting regulatory requirements. Knowing and understanding the consequences, the organisation and the employee will change their attitude toward product quality and consumer safety. It is vital for the pharmaceutical industry to continue to educate and develop their employees to meet the regulatory requirement and to succeed in the business world.
Bottom Line
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Human error is confirmed to be major cause of quality, safety and productivity in many domains. Why do humans make errors? Do you know how much impact human error has on bottom line in your organisation?
Solution
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There are steps, which can be taken in order to minimise human error in the pharmaceutical industry. AmazonPharma can conduct employee surveys to investigate your employee behaviour (i.e. employee morale, commitment to the quality, productivity, occupational health and safety and other operational issue).
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AmazonPharma use specially designed and developed survey tools to assess organisational culture. The cultural assessment tools can be designed to suit organisations specific needs. The tools may include observational checklist, interview questionnaire, or survey questionnaire. This Behavioural GMP Module offers the pharmaceutical industry, a designed and validated Survey Questionnaire and Observational checklist. The Questionnaires may assist in assessing organisational culture in order to investigate and reduce human error causes.
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AmazonPharma Behavioural cGMP Module provides the required direction to be taken to investigate and to reduce human error caused by employee behaviour. The Module will improve employees understanding, relating to behaviour impacts on quality, productivity and morale in the organisation. The Module will improve compliance with Good Manufacturing Practice (GMP) and Occupational Health and Safety (OHS) regulation.
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The impact of employees behaviour to organisation compliance and performance will be considered. Remedy Plan will be designed and implemented based on findings. To remedy human error ongoing training plays a vital role. Commitments to the safety and top-level quality are necessary.
Accountability 
