Validation and the human element

Frequently the steps in the process which involve human intervention are the weak links in the process, the steps representing the highest risk. This is not due to lack of training or motivation of people, but to weaknesses in the design of the process and to the intrinsic error rate of manual operations. Quite often in validation work the human element is ignored while mechanical and technological aspects are studied in great detail. This article will include some examples about what we have learned about risk where human intervention is involved by using Failure Mode Effect Analysis (FMEA) and Process Reengineering methodologies. Furthermore, the implications for training and qualification of people in the validation context will be discussed.