Remote PCQI Services for Preventive Controls
FDA Preventive Controls Development by a Preventive Controls Qualified Individual (PCQI)
Determine and Document Preventive Controls in Compliance with 21 CFR 117.135
Once hazards have been identified through a Hazard Analysis, the next critical step is determining which Preventive Controls are necessary to significantly minimize or prevent those hazards. Under 21 CFR §117.135, facilities subject to the Food Safety Modernization Act (FSMA) must establish and implement risk-based preventive controls as part of their written Food Safety Plan.At PCQIServices.com, we provide professional Remote PCQI Services to assist food manufacturers, processors, packers, warehouses, importers, beverage companies, co-packers, contract manufacturers, and private label brands in developing FDA-compliant Preventive Controls that protect consumers and support regulatory compliance.
Our experienced Preventive Controls Qualified Individuals (PCQIs) work remotely with your food safety team to identify, document, and maintain preventive controls that are practical, science-based, and tailored to your operation.
What Are Preventive Controls?
Preventive Controls are risk-based procedures, practices, and processes designed to significantly minimize or prevent identified food safety hazards. They are established after completing the Hazard Analysis and form one of the core elements of an FDA-compliant Food Safety Plan.
Effective Preventive Controls help your organization:
- • Prevent food safety hazards before they occur
- • Protect consumers from illness or injury
- • Meet FDA Preventive Controls requirements
- • Reduce product recalls and regulatory actions
- • Improve consistency in manufacturing operations
- • Demonstrate regulatory compliance during FDA inspections
Why Hire a Remote PCQI?
Determining appropriate Preventive Control requires technical knowledge of food safety hazards, manufacturing processes, FDA regulations, and preventive control strategies.
Our Remote PCQI Service provides expert guidance without the cost of employing a full-time food safety professional.
We help organizations:
- • Evaluate hazards requiring preventive controls
- • Determine appropriate control measures
- • Document preventive controls
- • Establish monitoring activities
- • Develop corrective action procedures
- • Support verification and validation
- • Maintain Food Safety Plan compliance
Monthly Remote PCQI Service
$750 Per Month
Includes Up to 25 Hours of Professional PCQI Support
$750 Per Month
Includes Up to 25 Hours of Professional PCQI Support
Your monthly subscription includes:
- • Preventive Controls development
- • Food Safety Plan support
- • Hazard Analysis review
- • Monitoring procedure development
- • Corrective Action procedure development
- • Verification support
- • Validation guidance
- • FDA regulatory consultation
- • Virtual meetings
- • Email and telephone support
- • Compliance recommendations
- • Monthly activity reporting
Unused hours do not carry over to the following month.
Scope of Preventive Controls Services
Evaluation of Hazard Analysis
Our Preventive Controls Qualified Individual (PCQI) reviews your Hazard Analysis to determine which identified hazards require one or more Preventive Controls based on hazard severity, the probability of occurrence, product characteristics, processing methods, and intended use.
Our PCQI evaluates:
Process Preventive Controls
We develop Process Preventive Controls that manage identified food safety hazards through manufacturing processes.
Examples include:
- • Time controls
- • Temperature controls
- • Thermal processing
- • pH management
- • Water activity controls
- • Formulation controls
- • Cooling procedures
- • Mixing requirements
- • Metal detection
- • Critical operational parameters
Food Allergen Preventive Controls
Food allergen management is essential for facilities that manufacture or handle allergenic ingredients.
Our services include:
- • Allergen identification
- • Allergen segregation
- • Cross-contact prevention
- • Label review
- • Label verification
- • Packaging controls
- • Changeover procedures
- • Allergen cleaning verification
Sanitation Preventive Controls
We establish Sanitation Preventive Controls designed to minimize environmental and operational contamination.
These may include:
- • Cleaning and sanitation procedures
- • Environmental pathogen control
- • Hygienic zoning
- • Employee hygiene requirements
- • Equipment sanitation
- • Facility sanitation
- • Cleaning verification
- • Sanitation records
Supply-Chain Preventive Controls
When hazards are controlled before ingredients arrive at your facility, FDA regulations may require a Supply-Chain Program.
Our PCQI assists with:
- • Supplier approval
- • Supplier verification
- • Supplier performance review
- • Certificates of Analysis (COA) evaluation
- • Audit review
- • Foreign Supplier documentation
- • Incoming material verification
Other Preventive Controls
Where appropriate, additional Preventive Controls may be established for unique products, ingredients, manufacturing methods, or customer requirements.
Integration with Your Food Safety Plan
Preventive Controls are incorporated into your written Food Safety Plan and integrated with:
- • Hazard Analysis
- • Monitoring Procedures
- • Corrective Action Procedures
- • Verification Activities
- • Validation Documentation
- • Recordkeeping Requirements
- • Supply-Chain Program
- • Recall Plan (when applicable)
Deliverables
Your Preventive Controls engagement may include:
Preventive Controls Documentation
- • Preventive Controls Summary
- • Process Preventive Controls
- • Food Allergen Preventive Controls
- • Sanitation Preventive Controls
- • Supply-Chain Preventive Controls
- • Preventive Control Decision Documentation
Supporting Procedures
- • Monitoring Procedures
- • Corrective Action Procedures
- • Verification Procedures
- • Validation Documentation
- • Operational Instructions
- • Recordkeeping Requirements
Monthly Deliverables
- • Monthly Activity Report
- • Compliance Recommendations
- • Preventive Controls Review
- • Meeting Minutes
- • Action Item Tracker
Industries We Support
Our Remote PCQI Preventive Controls Services support:
- • Food Manufacturers
- • Beverage Manufacturers
- • Seafood Processors
- • Produce Facilities
- • Bakeries
- • Dairy Facilities
- • Frozen Food Manufacturers
- • Snack Food Companies
- • Ingredient Manufacturers
- • Dietary Supplement Manufacturers
- • Contract Manufacturers
- • Co-Packers
- • Importers
- • Private Label Brands
- • Food Warehouses
Why Choose PCQIServices.com?
Preventive Controls should be practical, measurable, and effective—not overly complicated.
Companies choose PCQIServices.com because we provide:
- • Experienced Preventive Controls Qualified Individuals (PCQIs)
- • FDA-focused regulatory expertise
- • Facility-specific preventive control strategies
- • Practical documentation that supports daily operations
- • Affordable monthly service
- • Remote support across the United States and internationally
- • Ongoing compliance guidance
Frequently Asked Questions
What are Preventive Controls?
Preventive Controls are risk-based procedures, practices, and processes implemented to significantly minimize or prevent identified food safety hazards as required by 21 CFR §117.135.
Who determines Preventive Controls?
A Preventive Controls Qualified Individual (PCQI) determines or oversees the determination of appropriate Preventive Controls based on the facility's Hazard Analysis and operational risks.
What types of Preventive Controls are required?
Depending on your operation, Preventive Controls may include:
- • Process Preventive Controls
- • Food Allergen Preventive Controls
- • Sanitation Preventive Controls
- • Supply-Chain Preventive Controls
- • Other Preventive Controls
FDA Regulation
21 CFR §117.135 – Preventive Controls
Under 21 CFR §117.135, facilities must identify and implement risk-based Preventive Controls that provide assurances that identified hazards will be significantly minimized or prevented.
Preventive Controls may include:
- • Process Preventive Controls
- • Food Allergen Preventive Controls
- • Sanitation Preventive Controls
- • Supply-Chain Preventive Controls
- • Recall Plan integration, where applicable
- • Supporting management components, including monitoring, corrective actions, verification, validation, and recordkeeping
Request a Free Consultation
Need assistance determining and documenting Preventive Controls for your Food Safety Plan?
Partner with PCQIServices.com for professional Remote PCQI Preventive Controls Services and receive expert guidance tailored to your facility, products, and manufacturing processes.
Remote PCQI Service
$750 Per Month
Up to 25 Hours of Professional PCQI Support
$750 Per Month
Up to 25 Hours of Professional PCQI Support
➜ FDA-Compliant Preventive Controls
➜ Experienced Preventive Controls Qualified Individuals (PCQIs)
➜ Nationwide & International Remote Service
➜ Experienced Preventive Controls Qualified Individuals (PCQIs)
➜ Nationwide & International Remote Service
Contact us today to schedule your free consultation and strengthen your Food Safety Plan with science-based Preventive Controls.
Fees and Subscriptions
Initial Setup Fees
| Plan | Description | One-Time Fee |
|---|---|---|
| CAP Lite | 1 corrective action plan template + logbook | $650 |
| Standard Incident Response Pack | Full CAP program + training + food safety reanalysis trigger tool | $1,500 |
| Comprehensive CAP Suite | Includes RCA tools, CAP/Correction integration, and food disposition support | $2,800 |
Monthly Maintenance Fees
| Plan | Monthly Maintenance | Monthly Fee |
|---|---|---|
| Standard | Quarterly incident review support + minor template updates | $250/month |
| Premium | Monthly review of CAP logs + RCA support + retraining access | $500/month |
| Enterprise | Incident investigation support, real-time CAP guidance, compliance alerts, and food safety plan reanalysis support | $850/month |
Monthly Maintenance Coverage Includes
- • Review and feedback on submitted corrective action reports
- • Root cause analysis consultation and corrective/preventive action refinement
- • Monthly summary of trends, repeated incidents, and improvement suggestions
- • Update of CAP templates based on FDA guidance or internal audit findings
- • Support for food safety plan reanalysis when required (per §117.170)
- • Email and chat access for urgent compliance queries or incident reporting
Ideal For:
- • Facilities with ready-to-eat (RTE) foods and pathogen monitoring requirements
- • Manufacturers preparing for FDA audits and needing proactive incident management
- • QA teams requiring structured response to food safety deviations or failures
- • Private labelers and co-manufacturers who need documented corrective action responses for client assurance
