Why Preventive Controls Matter in Food Safety

Preventive controls are the cornerstone of FSMA compliance, ensuring that food safety hazards are effectively managed before they pose a risk to consumers. The Preventive Controls Qualified Individual (PCQI) is responsible for conducting or overseeing the validation of the preventive controls and records review to maintain compliance with 21 CFR Part 117.

A well-executed preventive control system minimizes contamination risks, protects consumers, and prevents costly recalls. In this guide, we’ll outline how a PCQI ensures the proper validation, monitoring, and oversight of preventive controls.

Key Steps A PCQI Takes in Validating Preventive Controls

Validation is a data-driven process that ensures preventive controls work as intended. The FDA requires that PCQIs validate or oversee validation of controls before full-scale implementation. Here’s how:

1. Establish Scientific or Historical Justification

• Use scientific studies, regulatory guidance, or industry best practices to justify the chosen control.
• Reference published food safety studies on pathogen reduction, allergen control, or chemical hazard mitigation.

Actionable Tip: If scientific validation is unavailable, conduct internal validation studies to prove control effectiveness.

2. Conduct Practical Testing

• Perform small-scale testing under real operating conditions.
• Measure key parameters, such as temperature, time, and pH, to confirm effectiveness.
• Compare results against regulatory standards.

Example: A bakery implementing an allergen control plan may conduct swab tests before and after cleaning to validate sanitation controls.

3. Implement and Monitor Controls

Once validated, the control must be implemented consistently and correctly. This involves:

• Training personnel on standard operating procedures (SOPs).
• Establishing real-time monitoring systems to track compliance.
• Documenting validation and monitoring efforts for audit readiness.

Types of Preventive Controls and How A PCQI Oversees Them

Preventive controls fall into four primary categories, each designed to mitigate specific food safety hazards. A PCQI must ensure these controls are properly validated, monitored, and verified to maintain compliance.

1. Process Controls

These controls manage food processing conditions to eliminate or reduce biological hazards. Examples include:

• Thermal processing to kill pathogens (e.g., pasteurization, cooking requirements).
• pH and water activity control to prevent microbial growth.
• Time and temperature monitoring for perishable foods.

A PCQI can validate process controls by reviewing scientific studies or conducting in-house testing. The food safety plan must identify ongoing monitoring for effectiveness, including records review conducted or overseen by the PCQI.

2. Sanitation Controls

Sanitation controls focus on preventing contamination of food contact surfaces, equipment, product and the facility.These include:

• Cleaning and sanitizing protocols for equipment and processing areas.
• Employee hygiene programs such as handwashing and PPE use.
• Environmental monitoring for pathogens like Listeria in food facilities.

The food safety plan must include monitoring of sanitation effectiveness. This may include conducting swab testing, reviewing records, and implementing corrective actions when contamination risks are identified.

3. Supply Chain Controls

These controls ensure that raw materials and ingredients meet safety requirements before entering production. Key components include:

• Identifying supply-chain preventive controls
• Understanding the supplier’s process and facility hazards

PCQIs may need to conduct supplier audits to understand the supplier’s processes and become familiar with the facility in order to understand hazards that the supplier’s process or facility may present.

4. Allergen Controls

Allergen cross-contact is a major food safety risk, requiring strict preventive measures. Some effective allergen controls include:

• Ingredient segregation to prevent cross-contact during storage and processing.
• Labeling verification to ensure accurate allergen disclosures and proper labeling.
• Dedicated equipment and changeover procedures between allergen-containing and allergen-free products.

Allergen preventive controls must be implemented wherever there is a significant allergen hazard identified during hazard analysis. The PCQI is responsible for reviewing or overseeing the review of the monitoring records related to the preventive controls.

Overseeing Preventive Controls: Ongoing Monitoring & Verification

Validation is only the beginning—continuous monitoring and verification are required to maintain food safety compliance.

1. Monitoring Preventive Controls

The food safety plan must include monitoring systems to ensure preventive controls remain effective. The PCQI will oversee the review of records to ensure effective implementation. This includes:

• Routine checks of equipment, temperature logs, and sanitation records.
• Real-time alerts for deviations in critical parameters.
• Visual inspections to confirm proper implementation.

Actionable Tip: Use automated monitoring systems where possible to improve efficiency and accuracy.

2. Verification Activities

Verification ensures that preventive controls continue to work as intended over time. Key verification methods include:

• Microbial testing to assess sanitation effectiveness.
• Equipment calibration to confirm accuracy.
• Internal audits and record reviews to detect inconsistencies.
• Records review by the PCQI or their designee.

Example: A dairy facility may verify pasteurization effectiveness by routinely testing product samples for bacterial contamination.

3. Corrective Actions & Continuous Improvement

If a preventive control fails, a corrective action plan must be in place to mitigate risk. The food safety plan includes corrective action plans to be followed in case of a deviation at a preventive control. This should include:

• Identifying the root cause of the failure.
• Taking immediate action to prevent unsafe food from reaching consumers.
• Revising procedures and retraining staff if necessary.
• Review for effectiveness by the PCQI or their designee.

Actionable Tip: Regularly review data trends to identify early warning signs of control failures before they escalate.

Avoiding Common Pitfalls in Preventive Control Management

Even with a strong system in place, PCQIs should be aware of these common challenges:

• Failure to validate controls → Ensure all preventive controls have supporting scientific or in-house validation.
• Inconsistent monitoring → Standardize monitoring procedures and use checklists or automated tracking.
• Poor documentation → Maintain detailed records to demonstrate compliance during FDA inspections.

Strengthen Your Preventive Control Systems with PCQI Training

A PCQI plays a critical role in food safety, ensuring preventive controls are properly validated and continuously monitored. Staying ahead of regulatory changes and best practices is key to maintaining compliance.

Registrar Corp offers expert-led PCQI training courses and consulting services to help food manufacturers effectively validate and oversee their preventive controls.

Take a proactive approach—invest in proper training to protect your food supply and meet FSMA requirements.