Author: Ann McGee, managing director, McGee Pharma International
Human error frequently occurs in pharmaceutical manufacturing, even when the organisation considers that it has done everything to prevent its occurrence. Documentation appears accurate, personnel are fully trained and equipment operates as designed, but errors continue to be made.
In many organisations, human error is assigned as the root cause of the event, with reasons given such as ‘lack of attention to detail’ or ‘failure to follow procedure’. Corrective action will involve re-training or disciplinary action.
Such approaches do not seek to understand why the error(s) occurred and they certainly cannot be expected to prevent re-occurrence.
In this article, we look at the common causes of human error in pharmaceutical manufacturing and outline an approach to reducing these errors, with an objective to offer an insight into the common causes of human error in the area of pharmaceutical manufacturing and to provide a defined approach to investigating risk-influencing factors (RIFs) and root cause, reducing human error and sustaining error reduction within companies.
DEFING HUMAN ERROR
So, what is human error and why is its impact so important for pharmaceutical manufacture? An error is a deviation from accuracy or correctness. ‘Human error’ is a mistake made by a person rather than a machine, states the Oxford English Dictionary.
According to Dr Kevin O’Donnell (Irish Medicines Board, 2009), “Human error is frequently cited as a primary cause of quality defect issues that have led to batch recalls”.
Indeed, as Dr O’Donnell highlighted at the PharmaChem Skillsnet & PharmaChemical Ireland Conference in Cork in December 2009, the Irish Medicines Board (IMB) has reported that 25% of all quality defects – such as deviations, laboratory errors, complaints and inspection issues – are attributed to human error.