The Preventive Controls for Human Food regulation (often referred to as FSMA) is a law enacted to ensure safe preparation of food products for human consumption in the US in order to prevent food borne illnesses. In September of 2015 the FDA announced the deadlines for businesses to comply with the new rule. These deadlines are rapidly approaching and the law requires many businesses to be compliant with the Preventive Controls for Human Food Final Rule as early as September 2016.
The regulation requires that certain activities be performed by a Preventive Controls Qualified Individual (PCQI) who has successfully completed training in the development and application of risk-based preventive controls.
A Preventive controls qualified individual “means a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system.” This is the definition is from Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation § 117.3 and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Food for Animals regulation § 507.3.
Under the Preventive Controls for Human Food rule, the responsibilities of a “preventive controls qualified individual” include to oversee or perform 1) preparation of the Food Safety Plan, 2) validation of the preventive controls, 3) records review, 4) reanalysis of the Food Safety Plan, and other activities as appropriate to the food.
One way to become a PCQI, is to take the Preventive Controls for Human Food Course. This course, taught by a Preventive Controls for Human Foods Lead Instructor was developed by FSPCA in collaboration with the FDA. You will then receive your training certificate which is issued by the Association of Food and Drug Officials (AFDO).
Your FSMA Safety Plan will need to be written by a trained PCQI.
If you need to train many PCQIs, search for a Lead Instructor to provide on-site training for your company.
If your company prefers to hire an outside PCQI, browse the list of providers.