Under the Preventive Control rules, the U.S. Food and Drug Administration (FDA) requires facilities to create and maintain written food safety plans. Most facilities who manufacture, process, or pack food and beverage products for the U.S. market must implement food safety plans that follow Hazard Analysis and Risk-Based Preventive Controls (HARPC) standards.
There are many similar food safety schemes such as Hazard Analysis and Critical Control Points (HACCP), BRC, ISO 22000, GFSI, etc. However, none of these plans completely satisfy the requirements of FDA’s Preventive Controls rules. If a company chooses to rely solely on a different food safety scheme, such as HACCP, FDA may issue regulatory action, including detention, refusal, Warning Letters, or Import Alerts.
HARPC vs. HACCP: What’s the difference?
HACCP covers many of the same areas as HARPC, but there are some key differences.
In addition to the biological, chemical, and physical hazards typically identified in a HACCP plan, a HARPC plan must also identify and establish controls for radiological hazards, hazards intentionally introduced for economic gain, and allergens. Where HACCP requires controls at Critical Control Points, “preventive controls” required by HARPC may be applied at other points in a facility’s processes and may encompass allergen, sanitation, and supply-chain controls.
In contrast to a HACCP plan, a HARPC plan must be written and overseen by a Preventive Controls Qualified Individual (PCQI). A PCQI is a person that has either completed a standard curriculum approved by FDA or has the necessary education, training, or experience to develop and maintain a food safety plan.
For a comprehensive explanation of the differences between these two plans, download Registrar Corp’s complimentary whitepaper.
My facility does not have a HARPC plan. What should I do?
The deadline for most facilities to develop a HARPC plan has passed. If your facility is subject to Preventive Controls requirements and does not have a HARPC plan, it is prudent to develop one immediately. FDA’s fiscal year (FY) 2018 inspection observation data shows that the Agency is regularly inspecting facilities for compliance with the Preventive Controls rules.
Registrar Corp’s Food Safety Specialists are PCQIs who can develop an FDA-compliant HARPC plan for your facility. For more information, contact us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.