An introduction to the IUPAC/CITAC Guide (2016): Classification, modeling and quantification of human errors in a chemical analytical laboratory

6^th International Conference and Exhibtion on Pharmaceutical Regulatory Affairs and IPR

September 29-30, 2016 Orlando, USA

Ilya Kuselman

Independent Consultant on Metrology, Israel
National Physical Laboratory of Israel, Israel
National University of Science and Technology â�?�?MISISâ�?, Russia

Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

This Guide is developed by the project joint team of the International Union of Pure and Applied Chemistry (IUPAC) and the Cooperation on International Traceability in Analytical Chemistry (CITAC). Human error in a routine analytical laboratory is one of the major root causes of atypical test results. In particular, there are out-of-specification test results that fall outside the established specifications in the pharmaceutical industry, or do not comply with regulatory, legislation or specification limits in other industries and fields. Reducing human errors requires a study of the problem: the error classification, modelling and quantification. Classification of human errors in this Guide includes commission errors (mistakes and violations) and omission errors (lapses and slips) by different scenarios at different steps of the chemical analysis. A Swiss cheese model is used for characterization of the error interaction with a laboratory quality system. Quantification of the errors, based on expert judgments, i.e. on the expert(s) knowledge and experience, is applied. Monte Carlo simulation of the expert judgments was used for determination of distributions of the error quantification scores (scores of likelihood and severity, and scores of effectiveness of a laboratory quality system against the errors). Residual risk of human errors, remaining after the error reduction by the laboratory quality system, and consequences of this risk for quality and measurement uncertainty of chemical analytical results are discussed. Examples are provided using expert judgments on human errors in pH measurement of groundwater, multi-residue analysis of pesticides in fruits and vegetables, and elemental analysis of geological samples by inductively coupled plasma mass spectrometry. An introduction to this Guide in the lecture may be helpful for understanding the metrological and quality principles of the proposed solutions.

Biography :

Email: ilya.kuselman@bezeqint.net, ilya.kuselman@gmail.com