Stop Food Safety Risks Before They Start: Why Preventive Controls Matter Under 21 CFR §117.1
In today’s complex food supply chain, regulatory compliance is no longer optional—it’s essential. The FDA’s Food Safety Modernization Act (FSMA) has shifted the industry from reactive to preventive measures, placing a strong emphasis on identifying and controlling potential risks before they cause harm. One of the most critical components of this shift is found in 21 CFR §117.1, which outlines the framework for Preventive Controls for Human Food.
What Are Preventive Controls?
Preventive Controls are risk-based strategies that FDA-regulated facilities must implement to ensure food safety. These controls include procedures, practices, and processes designed to:
- • Prevent or minimize known or reasonably foreseeable hazards
- • Protect against contamination
- • Avoid adulteration during production, processing, packaging, and storage
Who Needs to Comply?
Any facility that manufactures, processes, packs, or holds food for human consumption in the U.S.—whether domestic or foreign—must comply with 21 CFR §117 if they are not exempt under specific conditions (e.g., qualified facilities, certain low-risk operations).
Key Requirements Under 21 CFR §117.1
- • Hazard Analysis: Identify potential biological, chemical, and physical hazards
- • Preventive Controls: Establish processes such as allergen management, sanitation, supply-chain programs, and process controls
- • Monitoring and Verification: Track performance and ensure control measures are effective
- • Corrective Actions: Define how to address deviations or failures
- • Recordkeeping: Maintain proper documentation to demonstrate compliance
How PCQIServices.com Can Help
At PCQIServices.com, we specialize in delivering PCQI-led compliance programs tailored to your facility’s needs. Our team helps you:
- ✔ Develop compliant food safety plans
- ✔ Perform thorough hazard analyses
- ✔ Set up preventive controls and corrective action plans
- ✔ Train personnel under the guidance of certified Preventive Controls Qualified Individuals (PCQIs)
- ✔ Stay inspection-ready with ongoing documentation and review support
The Bottom Line
Preventing food safety risks is more than good business—it’s the law. With FSMA enforcement ramping up and FDA inspections increasingly data-driven, now is the time to invest in a proactive compliance strategy.
Get Started Today
Don’t wait for a violation to force your hand. Partner with PCQIServices.com to build a rock-solid preventive controls program that keeps your operations safe, compliant, and audit-ready.