Abstract
Using a carrot processing line in a fresh-cut produce processing plant, it was found that Failure Mode and Effects Analysis (FMEA) provided a more accurate portrayal of the risk that is associated with a fresh-cut processing line than that provided by a conventional Hazard Analysis. This conclusion is based on the fact that FMEA clearly indicates the residual risk that is left after risk-mitigating activities are in place, and identifies the variables responsible for the remaining risk factor. This methodology also requires examination of the risk associated with all product and process changes that are involved in processing, with an integral part of this approach being the need for continuous improvement. FMEA, therefore, has the potential to decrease the likelihood that food processors will sell contaminated food to consumers because they have not detected when their biological hazards are not being adequately controlled, a classical type 2 error. It was also demonstrated that FMEA required a rating of the hazard detection method which drives the need to examine detection methods for hazards. In this example, a Run Chart was used to indicate changes in the microbiological status of a fresh-cut processing line. While the Run Chart successfully indicated this change, the information gained was not useful for showing the presence of a significant biological hazard. It was determined that this occurred because the information was not provided sufficiently in time to prevent the sale of contaminated carrots to customers. Use of a Defect Opportunity Checklist (DOC) was assessed to detect defects in a sanitation process; in effect, whether or not planned activities were being followed. This information was subsequently analyzed and an improvement plan was developed. While the DOC successfully performed this function, it was not adopted by the processing site because the current methods for verifying the sanitation indicated that the process was acceptable. This suggests that there may be limited acceptance of FMEA and DOC by food processors if it is perceived they perceive that their hazards are fully controlled by their existing food safety methodologies.