Analytical Performance Assessment and Improvement by Means of the Failure Mode and Effect Analysis (FMEA)

Introduction: Laboratories minimize risks through quality control but analytical errors still occur. Risk management can improve the quality of processes and increase patient safety. This study aims to use the failure mode and effect analysis (FMEA) to assess the analytical performance and measure the effectiveness of the risk mitigation actions implemented.

Materials And Methods: The measurands to be included in the study were selected based on the measurement errors obtained by participating in an External Quality Assessment (EQA) Scheme. These EQA results were used to perform an FMEA of the year 2017, providing a risk priority number that was converted into a Sigma value (σ). A root-cause analysis was done when σ was lower than 3. Once the causes were determined, corrective measures were implemented. An FMEA of 2018 was carried out to verify the effectiveness of the actions taken.

Results: The FMEA of 2017 showed that alkaline phosphatase (ALP) and sodium (Na) presented a σ of less than 3. The FMEA of 2018 revealed that none of the measurands presented a σ below 3 and that σ for ALP and Na had increased.

Conclusions: Failure mode and effect analysis is a useful tool to assess the analytical performance, solve problems and evaluate the effectiveness of the actions taken. Moreover, the proposed methodology allows to standardize the scoring of the scales, as well as the evaluation and prioritization of risks.