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Remote PCQI Services for Food Safety Plan Reanalysis

FDA Food Safety Plan Reanalysis by a Preventive Controls Qualified Individual (PCQI)
Reanalyze Your Food Safety Plan in Compliance with 21 CFR 117.170

A Food Safety Plan is not a one-time document. As your products, processes, ingredients, equipment, suppliers, and regulatory requirements change, your Food Safety Plan must be reviewed and updated to ensure it continues to protect consumers and comply with FDA regulations.

Under 21 CFR §117.170, facilities must reanalyze their Food Safety Plan at least once every three years, or sooner whenever significant changes occur that could affect food safety.

At PCQIServices.com, we provide professional Remote PCQI Food Safety Plan Reanalysis Services to help food manufacturers, processors, packers, warehouses, beverage companies, ingredient suppliers, contract manufacturers, co-packers, importers, and private label brands maintain FDA-compliant Food Safety Plans through ongoing review, evaluation, and continuous improvement.

Our experienced Preventive Controls Qualified Individuals (PCQIs) work remotely with your organization to evaluate your existing Food Safety Plan, identify necessary updates, revise documentation, and ensure continued compliance with FDA Preventive Controls regulations.

Why Food Safety Plan Reanalysis Is Important

Food manufacturing operations evolve over time. New ingredients, new suppliers, process improvements, equipment upgrades, customer requirements, and regulatory changes can all affect your Food Safety Plan.

Regular reanalysis helps your organization:
  • • Meet FDA requirements under 21 CFR §117.170
  • • Maintain an effective Food Safety Plan
  • • Identify emerging food safety risks
  • • Update Hazard Analyses
  • • Improve Preventive Controls
  • • Reduce regulatory risk
  • • Prepare for FDA inspections
  • • Support continuous improvement

A current Food Safety Plan is one of the strongest indicators of an effective Food Safety Management System.

Why Hire a Remote PCQI?

Food Safety Plan reanalysis requires a comprehensive understanding of FDA regulations, food safety hazards, preventive controls, manufacturing operations, and documentation requirements.

Our Remote PCQI Service provides experienced regulatory oversight without the expense of employing a full-time food safety professional.

We help organizations:
  • • Reanalyze Food Safety Plans
  • • Review Hazard Analyses
  • • Update Preventive Controls
  • • Evaluate monitoring procedures
  • • Review corrective action programs
  • • Assess verification activities
  • • Update validation documentation
  • • Revise Food Safety Plan records
  • • Prepare for FDA inspections
Monthly Remote PCQI Service

$750 Per Month

Includes Up to 25 Hours of Professional PCQI Support

Your monthly subscription includes:
  • • Food Safety Plan Reanalysis
  • • Food Safety Plan Updates
  • • Hazard Analysis Review
  • • Preventive Controls Review
  • • Compliance Evaluations
  • • 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 Verification Record Review Services

Comprehensive Food Safety Plan Review
Our Preventive Controls Qualified Individual (PCQI) performs a systematic review of your existing Food Safety Plan to determine whether updates are necessary.
The review includes:
  • • Food Safety Plan documentation
  • • Facility operations
  • • Manufacturing processes
  • • Products
  • • Ingredients
  • • Packaging
  • • Storage and distribution
  • • Supporting prerequisite programs
Hazard Analysis Reassessment
We determine whether your Hazard Analysis remains accurate and complete.
The review considers:
  • • New biological hazards
  • • New chemical hazards
  • • Food allergens
  • • Physical hazards
  • • Radiological hazards
  • • Supplier changes
  • • Process changes
  • • Scientific developments
  • • Emerging food safety risks
Preventive Controls Review
Our Preventive Controls Qualified Individual (PCQI) evaluates whether existing Preventive Controls remain appropriate.
The review includes:
  • • Process Preventive Controls
  • • Food Allergen Preventive Controls
  • • Sanitation Preventive Controls
  • • Supply-Chain Preventive Controls
  • • Other Preventive Controls
Recommendations are provided whenever improvements are needed.
Monitoring Procedure Review
Monitoring procedures are evaluated to confirm:
  • • Monitoring activities remain appropriate
  • • Monitoring frequencies remain effective
  • • Monitoring responsibilities are current
  • • Monitoring records continue to support compliance
Corrective Action Review
We evaluate:
  • • Corrective Action Procedures
  • • Root cause investigations
  • • Product disposition processes
  • • Effectiveness of corrective actions
  • • Recurring deviations
  • • Opportunities for improvement
Verification and Validation Review
Our reanalysis includes evaluation of:
  • • Verification procedures
  • • Validation documentation
  • • Monitoring record reviews
  • • Corrective Action reviews
  • • Calibration programs
  • • Product testing
  • • Environmental monitoring
  • • Internal audits
Documentation Updates
When changes are identified, our Preventive Controls Qualified Individual (PCQI) updates your Food Safety Plan and supporting documentation.
Updates may include:
  • • Hazard Analysis revisions
  • • Preventive Control revisions
  • • Procedure updates
  • • Record updates
  • • New forms
  • • Revision history
  • • Document approval records
Significant Change Assessment
FDA requires reanalysis whenever significant changes could affect food safety.
Examples include:
  • • New products
  • • New ingredients
  • • New suppliers
  • • New equipment
  • • New processing methods
  • • Facility expansion
  • • Packaging changes
  • • New regulations
  • • Food safety incidents
  • • Product recalls
Our Preventive Controls Qualified Individual (PCQI) evaluates whether these changes require updates to your Food Safety Plan.

Deliverables

Your Food Safety Plan Reanalysis engagement may include:
Reanalysis Documentation
  • • Food Safety Plan Reanalysis Report
  • • Hazard Analysis Review
  • • Preventive Controls Review
  • • Gap Assessment
  • • Regulatory Compliance Review
  • • Revision Summary
Updated Documentation
  • • Updated Food Safety Plan
  • • Updated Hazard Analysis
  • • Updated Preventive Controls
  • • Updated Procedures
  • • Updated Forms
  • • Revision History Log
  • • Document Approval Record
Monthly Deliverables
  • • Monthly Activity Report
  • • Compliance Recommendations
  • • Reanalysis Summary
  • • Meeting Minutes
  • • Action Item Tracker
Industries We Support
Our Food Safety Plan Reanalysis services support:
  • • Food Manufacturers
  • • Beverage Manufacturers
  • • Bakeries
  • • Dairy Facilities
  • • Seafood Processors
  • • Produce Operations
  • • Frozen Food Manufacturers
  • • Ingredient Manufacturers
  • • Snack Food Companies
  • • Dietary Supplement Manufacturers
  • • Contract Manufacturers
  • • Co-Packers
  • • Importers
  • • Private Label Brands
  • • Food Warehouses

Why Choose PCQIServices.com?

Your Food Safety Plan should evolve with your business. A plan that has not been reviewed for years may no longer reflect your current operations, creating unnecessary compliance risks.

Companies choose PCQIServices.com because we provide:
  • • Experienced Preventive Controls Qualified Individuals (PCQIs)
  • • FDA-focused regulatory expertise
  • • Practical, facility-specific recommendations
  • • Comprehensive document reviews
  • • Affordable monthly service
  • • Remote nationwide and international support
  • • Ongoing compliance guidance

Our objective is to help your organization maintain an accurate, effective, and FDA-compliant Food Safety Plan that reflects your current operations and supports long-term food safety success.

Frequently Asked Questions

When must a Food Safety Plan be reanalyzed? FDA regulations require Food Safety Plans to be reanalyzed at least once every three years, or sooner whenever significant changes occur that could affect food safety or when new information becomes available about hazards or preventive controls. What changes require Food Safety Plan reanalysis? Examples include:
  • • New products
  • • New ingredients
  • • New suppliers
  • • Process changes
  • • Equipment changes
  • • Facility modifications
  • • Packaging changes
  • • Product recalls
  • • New scientific information
  • • Regulatory changes
Who should perform a Food Safety Plan reanalysis? A Food Safety Plan reanalysis should be conducted by, or under the oversight of, a Preventive Controls Qualified Individual (PCQI). Can Food Safety Plan reanalysis be completed remotely? Yes. Our Remote PCQI Services allow us to review documentation, evaluate processes, conduct virtual meetings, and update your Food Safety Plan without requiring an on-site visit in most cases. How much does your Food Safety Plan Reanalysis service cost? Our Remote PCQI Service is $750 per month and includes up to 25 hours of professional support for Food Safety Plan reanalysis, documentation updates, regulatory consultation, and ongoing compliance assistance.

FDA Regulation

21 CFR §117.170 – Food Safety Plan Reanalysis Under 21 CFR §117.170, facilities must reanalyze the Food Safety Plan at least once every three years or whenever significant changes occur that could affect food safety.
Food Safety Plan reanalysis should also be performed when:
  • • New information becomes available about potential hazards or preventive controls
  • • An unanticipated food safety problem occurs
  • • Significant operational changes could affect food safety
  • • Reanalysis is otherwise necessary to ensure the Food Safety Plan remains effective
Our Remote PCQI Food Safety Plan Reanalysis Service helps your organization maintain a current, risk-based, and FDA-compliant Food Safety Plan that reflects your actual operations and supports inspection readiness.

Request a Free Consultation

Is your Food Safety Plan due for reanalysis?

Partner with PCQIServices.com for professional Remote PCQI Food Safety Plan Reanalysis Services and keep your Food Safety Plan current, compliant, and ready for FDA inspection.

Remote PCQI Service

$750 Per Month

Up to 25 Hours of Professional PCQI Support

➜ FDA-Compliant Food Safety Plan Reanalysis
➜ Comprehensive Review and Document Updates
➜ Experienced Preventive Controls Qualified Individuals (PCQIs)
➜ Nationwide & International Remote Service

Contact us today to schedule your free consultation and ensure your Food Safety Plan remains effective and compliant.

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.