Determine which FDA regulatory framework applies

Assess whether the operation is subject to Juice HACCP under Part 120, whether other food activities trigger Part 117, and whether any exemptions or modified requirements apply.

Develop a complete juice hazard analysis

Evaluate hazards for each type of juice and the hazards reasonably likely to occur during the facility’s own processing, including blending, holding, and packaging.

Understand and establish the required 5-log process

Identify the pertinent microorganism and determine a process that achieves the required minimum 5-log reduction, subject to applicable provisions and exemptions. Confirm the process is applied at the facility where final product is packaged.

Validate process effectiveness and operating limits

Establish scientific support for the selected treatment, define operating parameters, and document validation and ongoing verification appropriate to the process.

Prevent recontamination after treatment

Assess downstream equipment, product contact surfaces, filling environment, packaging, and employee practices. Establish hygienic controls and monitoring.

Assess time-temperature and physical hazards

Evaluate ambient processing and holding for pathogen growth or toxin formation. Identify glass and other physical hazards associated with packaging.

Distinguish PCQI requirements for other food operations

Where a facility also manufactures foods subject to Part 117 preventive controls, assess whether a PCQI and written food safety plan are required for those activities.

Maintain monitoring, corrective action, and verification records

Document process monitoring, deviations, affected product evaluation, corrective actions, verification, and reassessment.

How Consultare Inc. Group Can Help

Your leading partner for Juice HACCP, preventive controls, and process validation support.

Consultare Inc. Group is positioning itself as the world’s No. 1 choice for food safety, regulatory compliance, certification consulting, and quality management solutions. Our ambition is to set the global standard through practical expertise, integrated services, and technology-driven compliance support.

Consultare can support Juice HACCP hazard analysis and plan review, 5-log process validation planning, PCQI and Part 117 applicability assessments for other food activities, time-temperature control procedures, sanitation and recontamination prevention, glass hazard controls, and corrective action. The regulatory pathway should be determined for each product and activity rather than assuming one framework applies to the entire facility.

Free Consultation

Need Help Managing Your PCQI Responsibilities?

Whether you manufacture conventional juice, probiotic juice, juice blends, or other beverages, request a free consultation through PCQIServices.com. Discuss your Juice HACCP plan, 5-log process, process validation, and PCQI requirements for any other applicable food operations. You can also create a free SystemsBuilder account to organize your compliance documentation and processes.

Start Building Your Compliance System

If you prefer to organize and manage your compliance activities yourself, you can also create a free SystemsBuilder account and begin building a structured system for your compliance documentation and processes.