Whatever can go wrong, need not go wrong: Open Quality approach for epidemiology.

Quality assurance is one of the most important aspects of an epidemiological study, as its validity is largely determined by data quality. The mounting success of quality management in the industrial sector caused a rapid spread throughout manufacturing industries and beyond. Yet, little has been published so far on quality assurance in epidemiology. In this article we review three models for quality assurance (Juran, Donabedian and ISO 9000) and showcase how these can be brought together in one intuitive, systematic and flexible approach to quality assurance in epidemiology. The resulting Open Quality approach refers back to the three processes identified by Juran (planning, control and verification). During the planning stage, we propose a subdivision of the study process in a set of steps and a definition of quality attributes corresponding to activities in that step as suggested by the ISO approach. We refer to the Donabedian model to determine the level at which the control/monitoring should take place-structure, processes or outcomes. Along with an overview of the Open Quality approach we propose an Open Quality tool to support the definition of quality attributes, failure modes, preventive strategies, verification activities, and corrective actions, which form the backbone of the Open Quality approach.