Failure mode and effects analysis in pharmaceutical research

Purpose – Quality management tools such as failure mode and effects analysis (FMEA) have been implemented in various industries to improve quality. This report aims to demonstrate that FMEA can be applied as a performance improvement tool, based on case analysis of process improvement conducted for a drug discovery project. Design/methodology/approach – The main points of the proposed FMEA process include: inclusion of an interface that makes it easy to visualize complicated processes in pharmaceutical research; identification of undesirable effects to indicate process defects; and a quantitative estimate of the undesirable effects related to quality and efficiency. Findings – The effectiveness of the proposed FMEA process was evaluated based on in vivo screening/profiling during early drug discovery. The process targeted for improvement was visualized using a flow diagram. The undesirable effects identified included waiting, false operations, and errors in the decisionmaking and reporting processes. The most serious flaws, determined by risk priority numbers for each category, were waiting and false operations. Originality/value – The effectiveness of the proposed FMEA was demonstrated by applying the analysis to another in vivo profiling process. Quantitative evaluation of the undesirable effects determined that they were reasonable. This provides a benefit for scientists seeking to improve the drug discovery process.