Pathogen testing methods are used to monitor the effectiveness of HACCP plans and need to provide high quality results to ensure safety of the food supply. To ensure that the best pathogen detection system is used at a given facility, it is important to gain an understanding of potential errors associated with a method so that false results can be minimized. For this purpose, a Failure Mode and Effect Analysis (FMEA) can be used to identify and quantify risk for a number of pathogen detection methods.
FMEA involves a review of the Product Inserts, identification of potential failure modes, and development of a Risk Priority Number (RPN) based on the total number of steps in a process, the total times the sample (or equivalent) is touched by an operator, and a weighting of the risk associated with the failure mode.
The higher the RPN number, the higher the risk is for the related method, which may provide a skewed and erroneous view of the effectiveness of the control plan being monitored.
FMEA study demonstrates that minimal steps and automation lead to superior results
A recent FMEA study demonstrated that minimizing the number of process steps as well as the number of touches per sample, and including automation that incorporates process control features can significantly reduce the total RPN or error potential of a detection method and will lead to higher quality results (see table below). It will further allow for improved efficiency of lab operations.
Want to learn more? Download the presentation "Ensuring Quality and Confidence in Pathogen Testing with Lean Six Sigma."