The preventive controls for human food rule specifies that a PCQI is 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 be otherwise qualified through job experience to develop and apply a food safety system. Job experience may qualify an individual to perform these functions if such experience has provided an individual with knowledge at least equivalent to that provided through the standardized curriculum.
There are some differences in the requirements of the CGMP & PC rule compared to the requirements of HACCP regulations and other preventive-based food safety programs such that the training provided by the International HACCP Alliance/GFSI/SQF/BRC etc or other institutions might not be equivalent. Such an individual may need additional training specific to the CGMP & PC rule. However, the CGMP & PC rule does not require any specific certifications, including certification by the FSPCA. In general, FDA will assess the adequacy of a facility’s food safety plan rather than an individual’s documented qualifications. Deficiencies in the food safety plan indicate that a PCQI may need additional training specific to the rule, irrespective of documented training and experience.