METHOD / MATRIX VALIDATION
Matrix and Sample Size Validation – Is Your Rapid Method of Analysis Fit for Purpose?
MATRIX VALIDATION REQUIREMENTS
FSMA mandated Preventive Controls must be verified to prove they are in place and working. Detecting failures and implementing corrective actions before a potential hazard is realized is key to a FSMA compliant food safety system. Detection is only as good as the tools used. The FDA expects that microbiological methods of analysis used to assess that a facility is in control, will be verified for all new food matrices and sample sizes not included in the original method validation study. This is to ensure that the new matrix is free from cross reactive substances that cause false positives, but more importantly, the matrix is free of inhibitory substances that can interfere with the detection of a pathogen and cause false negatives. Whether screening for environmental pathogens, conducting a challenge study or performing a process validation, methods must be validated for the matrix analyzed and the sample size used.
When a Matrix Validation is missing for an accredited rapid method of analysis, Deibel Laboratories can conduct a preliminary study that determines if there are apparent issues with the pairing of the food matrix and the detection technology. If there are no issues, a full -scale Matrix Validation study can be designed, grouping products where appropriate, to determine whether the method is appropriate for use with a client’s specific food matrix and/or sample size following AOAC PTM study guidelines.