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Risk analysis by FMEA as an element of analytical validatio:

van Leeuwen, J.F. ; Nauta, M.J. ; de Kaste, D....
Journal of Pharmaceutical and Biomedical Analysis.  50 (2009)  5 - p. 1085-1087 , 2009
Link: https://doi.org/10.1016/j.jpba.2009.06.049