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Remote PCQI Services for Food Safety Plan Development

FDA-Compliant Food Safety Plans Prepared by a Preventive Controls Qualified Individual (PCQI)
Prepare or Oversee the Development of Your Food Safety Plan in Compliance with 21 CFR 117.126

If your food facility manufactures, processes, packs, or holds food for consumption in the United States, the Food Safety Modernization Act (FSMA) may require your business to develop and maintain a written Food Safety Plan. Under 21 CFR §117.126, the Food Safety Plan must be prepared, or its preparation overseen, by one or more Preventive Controls Qualified Individuals (PCQIs).

At PCQIServices.com, we provide professional Remote PCQI Services to assist food manufacturers, food processors, beverage companies, bakeries, warehouses, importers, co-packers, contract manufacturers, and private label brands in developing FDA-compliant Food Safety Plans without the cost of employing a full-time food safety professional.

Our experienced Preventive Controls Qualified Individuals (PCQIs) work remotely with your management and food safety teams to develop practical, facility-specific Food Safety Plans that support regulatory compliance, reduce food safety risks, and prepare your organization for FDA inspections.

What Is a Food Safety Plan?

A Food Safety Plan is a written, science-based document that identifies food safety hazards and establishes preventive controls to significantly minimize or prevent those hazards. It serves as the foundation of your Food Safety Modernization Act (FSMA) compliance program and demonstrates your facility's commitment to producing safe food.
A properly developed Food Safety Plan helps your organization:
  • • Comply with FDA requirements under 21 CFR Part 117
  • • Identify food safety hazards before they occur
  • • Establish effective preventive controls
  • • Reduce the risk of product recalls
  • • Improve operational consistency
  • • Prepare for FDA inspections
  • • Strengthen customer confidence
  • • Support third-party food safety certifications

Why Hire a Remote PCQI?

Not every company requires a full-time Preventive Controls Qualified Individual (PCQI), but every covered facility needs qualified oversight of its Food Safety Plan.
Our Remote PCQI Service provides affordable access to experienced food safety professionals who can:
  • • Develop a new Food Safety Plan
  • • Review and update existing Food Safety Plans
  • • Conduct Hazard Analyses
  • • Establish Preventive Controls
  • • Develop Monitoring Procedures
  • • Create Verification and Corrective Action procedures
  • • Assist with Food Safety Plan reanalysis
  • • Provide ongoing FDA regulatory guidance
  • • Support FDA inspection readiness
This outsourced approach provides expert compliance support while reducing staffing costs and maintaining flexibility as your business grows.
Monthly Remote PCQI Service

$750 Per Month

Includes Up to 25 Hours of Professional PCQI Support

Your monthly subscription includes:
  • • Food Safety Plan development
  • • Food Safety Plan review and updates
  • • Hazard Analysis support
  • • Preventive Controls documentation
  • • Monitoring procedure development
  • • Corrective Action procedure development
  • • Verification activity documentation
  • • Validation support
  • • 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 Food Safety Plan Development Services

Food Safety Plan Preparation

Our Preventive Controls Qualified Individual (PCQI) prepares or oversees the preparation of a written Food Safety Plan that reflects your facility's products, processes, hazards, and operational controls.
The Food Safety Plan is developed specifically for your facility and may include:

Facility and Process Review

We review:
  • • Facility operations
  • • Manufacturing processes
  • • Product categories
  • • Ingredients and raw materials
  • • Process flow diagrams
  • • Equipment
  • • Packaging operations
  • • Storage and distribution activities
  • • Existing prerequisite programs

Food Safety Plan Components

Your Food Safety Plan may include:
  • • Hazard Analysis
  • • Preventive Controls
  • • Process Preventive Controls
  • • Food Allergen Preventive Controls
  • • Sanitation Preventive Controls
  • • Supply-Chain Program (when required)
  • • Recall Plan (when required)
  • • Monitoring Procedures
  • • Corrective Action Procedures
  • • Verification Procedures
  • • Validation documentation (where applicable)
  • • Recordkeeping requirements
Each section is prepared in accordance with FDA regulations and tailored to your operation.

Food Safety Plan Review and Maintenance

Our Remote PCQI also provides ongoing support by:
  • • Reviewing existing Food Safety Plans
  • • Updating documentation after operational changes
  • • Supporting periodic reanalysis
  • • Identifying compliance gaps
  • • Recommending continuous improvements
  • • Maintaining revision history

Deliverables

Your Remote PCQI engagement may include the following deliverables, depending on your facility's operations and regulatory requirements.
Food Safety Plan Documentation
  • • FDA-Compliant Food Safety Plan
  • • Facility Overview
  • • Product Description
  • • Intended Use Statement
  • • Process Flow Diagram Review
  • • Hazard Analysis
  • • Preventive Controls Summary
  • • Food Safety Plan Revision Log
Supporting Procedures
  • • Monitoring Procedures
  • • Corrective Action Procedures
  • • Verification Procedures
  • • Validation Documentation
  • • Record Review Procedures
  • • Supply-Chain Program Documentation (when applicable)
  • • Recall Plan (when applicable)
Monthly Deliverables
  • • Monthly Activity Report
  • • Compliance Recommendations
  • • Regulatory Guidance Summary
  • • Meeting Minutes
  • • Document Review Summary
  • • Action Item Tracker

Industries We Support

Our Remote PCQI Services are available for:
  • • Food Manufacturers
  • • Food Processors
  • • Beverage Manufacturers
  • • Bakeries
  • • Dairy Facilities
  • • Seafood Processors
  • • Produce Packing Operations
  • • Frozen Food Manufacturers
  • • Ingredient Suppliers
  • • Dietary Supplement Manufacturers
  • • Contract Manufacturers
  • • Co-Packers
  • • Private Label Brands
  • • Importers
  • • Food Warehouses
  • • Distribution Centers
  • • Start-Up Food Companies

Why Choose PCQIServices.com?

At PCQIServices.com, our focus is helping food businesses build practical, compliant Food Safety Plans that meet FDA requirements while supporting everyday operations.
Our clients value us because we provide:
  • • Experienced Preventive Controls Qualified Individuals (PCQIs)
  • • FDA-focused food safety expertise
  • • Practical, facility-specific documentation
  • • Remote nationwide and international support
  • • Predictable monthly pricing
  • • Responsive regulatory guidance
  • • Ongoing compliance assistance
  • • Scalable support for growing businesses
Our objective is to help your organization develop and maintain an FDA-compliant Food Safety Plan that supports regulatory compliance, protects food safety, and grows with your business.

Frequently Asked Questions

What is a Food Safety Plan? A Food Safety Plan is a written document required by the FDA that identifies food safety hazards and establishes preventive controls to minimize or prevent those hazards throughout the manufacturing process. Who must prepare a Food Safety Plan? Under 21 CFR §117.126, the Food Safety Plan must be prepared, or its preparation overseen, by one or more Preventive Controls Qualified Individuals (PCQIs). Can a PCQI develop a Food Safety Plan remotely? Yes. Most Food Safety Plans can be developed remotely through document review, process evaluations, virtual meetings, and collaboration with your facility personnel. Does every food facility need a Food Safety Plan? Most FDA-registered food facilities subject to 21 CFR Part 117 are required to develop and maintain a written Food Safety Plan unless a regulatory exemption applies.

How much does your Remote PCQI Service cost? Our Remote PCQI Service is $750 per month and includes up to 25 hours of professional support for Food Safety Plan development, regulatory consultation, and ongoing compliance assistance.

FDA Regulation

21 CFR §117.126 – Food Safety Plan The FDA requires that every written Food Safety Plan be prepared, or its preparation overseen, by one or more Preventive Controls Qualified Individuals (PCQIs). Depending on your operation, the Food Safety Plan includes:
  • • Hazard Analysis
  • • Preventive Controls
  • • Supply-Chain Program
  • • Recall Plan
  • • Monitoring Procedures
  • • Corrective Action Procedures
  • • Verification Procedures
  • • Supporting Records
Our Remote PCQI Service is specifically designed to help your facility comply with these requirements while building a practical and effective food safety management system.

Request a Free Consultation

Need a qualified PCQI to develop or oversee your Food Safety Plan? Partner with PCQIServices.com for professional Remote PCQI Services and receive expert guidance in developing an FDA-compliant Food Safety Plan tailored to your facility and operations.
Remote PCQI Service

$750 Per Month

Up to 25 Hours of Professional PCQI Support

➜ FDA-Compliant Food Safety Plans
➜ Remote Nationwide & International Service
➜ Experienced Preventive Controls Qualified Individuals (PCQIs)

Contact us today to schedule your free consultation and start building a stronger food safety program.

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

Get Started: Contact us at info@consultareinc.com or submit your request via our online form.