Yes, under the regulations established by FSMA, regardless of whether your food is RTE or not ready-to-eat you need to conduct a hazard analysis.2 The hazard analysis identifies and evaluates known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control. The hazard analysis must consider biological hazards, including microbiological hazards such as Salmonella, Listeria and E.coli, chemical, and physical hazards.
As part of the hazard analysis, you must assess the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls; you must include an evaluation of environmental pathogens whenever an RTE food is exposed to the environment prior to packaging and the packaged food does not receive a treatment that would significantly minimize the pathogen. You also must consider the effect of certain specified factors on the safety of the finished food for the intended consumer.
