What Are Process Controls & Why Do They Matter?

Among the four core categories of preventive controls required by FSMA, Process Controls are the most familiar. These are the procedures and parameters put in place to control biological, chemical, or physical hazards during the actual processing of food. The Preventive Controls Qualified Individual (PCQI) is responsible for ensuring that these controls are not only implemented, but also scientifically validated, consistently monitored, and fully documented.

Process controls can include a wide range of activities: heating, cooling, pH adjustment, fermentation, drying, and more. When managed effectively, they serve as a frontline defense against contamination and help ensure the safety and consistency of every product leaving your facility.

Step 1: Identify Where Process Controls Are Needed

The first step in applying process controls is to identify which steps in your production process pose significant food safety risks. This decision is based on the Hazard Analysis conducted during the development of the Food Safety Plan.

Common areas where process controls may be required:

• Cooking: To ensure pathogens are destroyed.
• Cooling: To prevent bacterial growth in ready-to-eat foods.
• Drying or Dehydrating: To reduce water activity and prevent mold or bacterial growth.
• Fermentation or Acidification: To create inhospitable environments for pathogens.

Actionable Tip: Use a process flow diagram alongside your hazard analysis to pinpoint where controls are most critical.

Step 2: Establish Critical Parameters and Limits

Once critical process steps are identified, the PCQI and food safety team must establish measurable parameters that define safe operation. These are known as critical limits and may include:

• Temperature (e.g., internal cook temp of 165°F for poultry)
• Time (e.g., hold time at a kill step)
• pH (e.g., target acidity below 4.6 for preservation)
• Water activity (aw)

These limits must be backed by scientific validation, either through:

• Published regulatory or industry standards
• Third-party scientific literature
• In-house validation studies, if no data is available

Actionable Tip: Always document the source of your critical limits and include validation references in your Food Safety Plan.

Step 3: Monitor Process Controls in Real Time

Ongoing monitoring is critical to ensuring that process controls remain effective during day-to-day operations. Monitoring activities must:

• Be performed at a frequency adequate to ensure control (often continuously or every batch)
• Be conducted by trained personnel following standard operating procedures (SOPs)
• Use calibrated equipment that is regularly verified

Examples of monitoring tools and methods:

• Digital thermometers and temperature loggers
• pH meters
• Time/temperature integrators (TTIs)
• Visual inspection with checklists

Actionable Tip: Automate monitoring where possible using data loggers or connected devices that provide real-time alerts for deviations.

Step 4: Take Prompt Corrective Actions

When monitoring reveals a deviation from the critical limit, the PCQI must ensure a documented corrective action is taken. This should include:

• Isolating or holding affected product
• Investigating root causes
• Reprocessing or discarding product as appropriate
• Re-training staff if procedural failures are involved

Actionable Tip: Maintain a library of standard corrective action procedures for the most common process deviations to ensure quick and consistent response.

Step 5: Verify and Validate for Long-Term Effectiveness

Verification ensures that process controls are being implemented properly. This includes:

• Review of monitoring records
• Equipment calibration logs
• Internal audits or third-party inspections

Validation confirms that the controls are scientifically capable of preventing the hazard. PCQIs may:

• Conduct in-house microbial challenge studies
• Compare pre- and post-process microbial loads
• Collaborate with food safety consultants for complex validations

Actionable Tip: Schedule periodic re-validation of critical process controls—especially when recipes, equipment, or suppliers change.

Avoiding Common Pitfalls in Process Control Management

• Assuming legacy processes are compliant → Conduct a full validation review of longstanding procedures.
• Relying solely on visual checks → Ensure measurable parameters (like temperature and pH) are tracked with instruments.
• Inconsistent documentation → Standardize forms and digital records to improve traceability and audit readiness.

Empower Your Process Control Program with PCQI Expertise

Strong process controls don’t run on autopilot. They require planning, precision, and oversight—core responsibilities of the PCQI. From defining parameters to training teams and handling deviations, PCQIs help food manufacturers stay compliant, efficient, and consumer-focused.

Registrar Corp offers PCQI training and consulting services to support process control development, validation, and FSMA compliance across food sectors.