Let’s focus on the FSMA requirement for companies to have Preventive Control Qualified Individuals (PCQIs),if you are thinking of enlisting a trainer or consultant, here are some fraud detection tips:
First ask the trainer or consultant if they know how the FSMA final rule relates to the USC-Title 21 and the Federal Food, Drug and Cosmetic Act. If they fumble in describing the relationship, do not hire them.
Secondly, ask them to provide an analysis of a "Preventive Control". See if they are able to accurately differentiate between "preventive controls" and "critical control points" as well as state the relationship between these. If they do not understand that "preventive controls" is the umbrella term that covers both critical control points and system control measures, do not hire them.
Also assess how much your prospective consultant or trainer can actually help you regarding the control of radiological hazards, etc. that are now included in the FSMA list of hazards. If they identify CCPs for controlling some of these hazards (for example a CCP for controlling radiological hazards in purchased raw materials), they may not be sufficiently knowledgeable about the relationship between preventive controls and CCPs, the proper application of CCPs, and the current global food trade practices. You should not hire them.