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03 Issues & Trends
Cereal Foods World, Vol. 64, No. 2
DOI: https://doi.org/10.1094/CFW-64-2-0018
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Preventive Controls Qualified Individual: Roles and Responsibilities
Ewa Pietrysiak, Barbara Rasco, and Girish M. Ganjyal1

School of Food Science, Washington State University, Pullman, WA, U.S.A.

1 Corresponding author. E-mail: girish.ganjyal@wsu.edu  


Abstract

The Food Safety Modernization Act (FSMA) Preventive Controls for Human Food (PCHF) rule takes a preventive approach to food safety. The first requirement of the PCHF rule is a documented hazard analysis. The FSMA PCHF rule requires that certain aspects of the food safety program be performed or supervised by a preventive controls qualified individual (PCQI). A PCQI is an individual who has successfully completed adequate training or is otherwise qualified through job experience to develop and implement a food safety plan. A PCQI manages important aspects of the food safety program and ensures that preventive controls are effective and proper records are maintained. This article describes the roles and responsibilities of a PCQI.




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References

  1. Ganjyal, G. M., and Coles, C. G. Preventive controls for human food: An overview. Fact Sheet FS282E. Available online at http://cru.cahe.wsu.edu/CEPublications/FS282E/FS282E.pdf. Washington State University Extension, Pullman, WA, 2017.
  2. U.S. Food and Drug Administration. FSMA final rule for preventive controls for human food. Current Good Manufacturing Practice, hazard analysis, and risk-based preventive controls for human food. CFR Title 21, Part 117. Published online at www.fda.gov/food/guidanceregulation/fsma/ucm334115.htm. FDA, Silver Spring, MD, 2015.
  3. U.S. Food and Drug Administration. Current Good Manufacturing Practice, hazard analysis, and risk-based preventive controls for human food—Definitions. CFR Title 21, Part 117, Section 117.3. Published online at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=117.3. FDA, Silver Spring, MD, 2018.
  4. U.S. Food and Drug Administration. Draft guidance for industry: Hazard analysis and risk-based preventive controls for human food. Published online at www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm517412.htm. FDA, Silver Spring, MD, 2018.