Risk analysis of analytical validations by probabilistic modification of FMEA.

@article{Barends2012RiskAO,
  title={Risk analysis of analytical validations by probabilistic modification of FMEA.},
  author={Dirk M. Barends and M T Oldenhof and Marjo J Vredenbregt and Maarten J. Nauta},
  journal={Journal of pharmaceutical and biomedical analysis},
  year={2012},
  volume={64-65},
  pages={82-6}
}
Risk analysis is a valuable addition to validation of an analytical chemistry process, enabling not only detecting technical risks, but also risks related to human failures. Failure Mode and Effect Analysis (FMEA) can be applied, using a categorical risk scoring of the occurrence, detection and severity of failure modes, and calculating the Risk Priority Number (RPN) to select failure modes for correction. We propose a probabilistic modification of FMEA, replacing the categorical scoring of… CONTINUE READING