The role of failure mode and effects analysis in improving the quality performance of dairy laboratories

Abstract

AbstractFailure modes and effects analysis (FMEA) is a proactive procedure for risk management and quality improvement in laboratories. The FMEA was carried out on pre‐analytical stage of ultra‐high‐temperature milk samples. It was applied at two different stages; in the first phase, the potential failure mode was chosen and the probable risks for failure mode were assessed and analyzed. Risk priority numbers (RPNs) were calculated to evaluate and organize reasons for potential failure and their impacts and identify the risk level. As for the second phase, it encompassed establishing and implementing the proposed action plans and measuring their effects. The uppermost RPN was human errors (504), followed by training (432), incorrect samples handling and transport (336), and insufficient sterilizing of tools (192). Employing the effective improvement action plan significantly decreased the RPN. The FMEA should be utilized as a regular tool to improve processes in laboratories.Practical applicationsThe failure modes and effects analysis (FMEA) method is used mainly to minimize errors, improve the quality of pre analytical stage of milk samples in the laboratory, identify potential failures, and develop and prioritize improvement strategies. Corrective actions significantly lower the risk priority numbers values. Besides, FMEA is a preventive tool and it is helpful in risk assessment of processes in dairy laboratories. The FMEA is a frequently‐used technique for quality assurance in food industry and numerous manufacturing industries addressing purchasers, governmental requirements, quality control, and safety. Nowadays, the FMEA is being applied in healthcare laboratories, and to attain all‐inclusive and fast improvement in safety in non‐healthcare industries.