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Remote PCQI Services for Process Change Evaluation

FDA Process Change Assessment by a Preventive Controls Qualified Individual (PCQI)
Evaluate Process Changes in Compliance with 21 CFR 117.170

Food manufacturing operations are constantly evolving. New ingredients, new suppliers, new equipment, new packaging, new products, and changes to manufacturing processes can all introduce new food safety hazards or affect the effectiveness of existing preventive controls.

Under 21 CFR §117.170, facilities must evaluate significant operational changes to determine whether the Food Safety Plan requires reanalysis and whether new hazards or preventive controls must be identified and documented.

At PCQIServices.com, we provide professional Remote PCQI Process Change Evaluation Services to help food manufacturers, processors, beverage companies, bakeries, ingredient suppliers, contract manufacturers, co-packers, importers, warehouses, and private label brands assess operational changes before they create compliance risks.

Our experienced Preventive Controls Qualified Individuals (PCQIs) work remotely with your organization to evaluate proposed and implemented changes, assess food safety impacts, update Food Safety Plans when necessary, and ensure continued compliance with FDA Preventive Controls requirements.

Why Process Change Evaluations Are Important

Every operational change has the potential to affect food safety. A seemingly simple change—such as switching suppliers, modifying packaging, installing new equipment, or changing cooking parameters—may introduce new hazards or require revisions to existing preventive controls.

A structured process change evaluation helps your organization:
  • • Meet FDA requirements under 21 CFR §117.170
  • • Identify new food safety hazards
  • • Determine whether preventive controls should be updated
  • • Reduce regulatory risk
  • • Prevent unexpected food safety issues
  • • Maintain an accurate Food Safety Plan
  • • Improve FDA inspection readiness

Why Hire a Remote PCQI?

Evaluating operational changes requires knowledge of food science, manufacturing processes, preventive controls, hazard analysis, and FDA regulations.

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

We help organizations:
  • • Evaluate operational changes
  • • Review new products
  • • Assess new ingredients
  • • Evaluate supplier changes
  • • Review equipment modifications
  • • Assess packaging changes
  • • Evaluate process changes
  • • Update Food Safety Plans
  • • Maintain FDA compliance
Monthly Remote PCQI Service

$750 Per Month

Includes Up to 25 Hours of Professional PCQI Support
Your monthly subscription includes:
  • • Process Change Evaluation
  • • Hazard Analysis Updates
  • • Preventive Controls Review
  • • Food Safety Plan Updates
  • • 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 Process Change Evaluation Services

Monitoring Record Review
Our Preventive Controls Qualified Individual (PCQI) reviews monitoring records to verify:
  • • Monitoring activities were completed
  • • Required frequencies were followed
  • • Critical limits were met
  • • Deviations were identified
  • • Required documentation was completed
  • • Records comply with your Food Safety Plan
Corrective Action Record Review
We review corrective action documentation to confirm:
  • • Appropriate corrective actions were implemented
  • • Product disposition decisions were documented
  • • Root cause investigations were completed
  • • Preventive measures were implemented
  • • Corrective actions were effective
Verification Record Review
Verification documentation is reviewed to ensure:
  • • Required verification activities were completed
  • • Calibration records were maintained
  • • Product testing was reviewed
  • • Environmental monitoring was evaluated
  • • Internal audits were documented
  • • Required follow-up activities were completed
Record Approval
After completing the review, our Preventive Controls Qualified Individual (PCQI) documents record approval, confirms regulatory compliance, and identifies any records requiring additional action before final acceptance.
Approval activities may include:
  • • Electronic record approval
  • • Manual record review sign-off
  • • Compliance review documentation
  • • Deficiency notifications
  • • Record approval tracking
  • • Regulatory comments
Documentation Quality Review
Our review evaluates:
  • • Completeness
  • • Accuracy
  • • Required signatures
  • • Dates and timestamps
  • • Legibility
  • • Record integrity
  • • Missing information
  • • Consistency with established procedures
Trend Analysis
Historical records are reviewed to identify:
  • • Recurring deviations
  • • Repeat corrective actions
  • • Equipment performance issues
  • • Documentation trends
  • • Employee training opportunities
  • • Supplier performance concerns
  • • Continuous improvement opportunities
Integration with Your Food Safety Plan
Food Safety Record Review and Approval supports:
  • • Hazard Analysis
  • • Preventive Controls
  • • Monitoring Procedures
  • • Corrective Action Procedures
  • • Verification Activities
  • • Validation Documentation
  • • Food Safety Plan Reanalysis
  • • Recordkeeping Requirements
This integrated approach helps ensure your Food Safety Plan remains effective, properly documented, and compliant with FDA regulations.

Deliverables

Your Process Change Evaluation engagement may include:
Evaluation Documentation
  • • Process Change Assessment Report
  • • Hazard Analysis Update
  • • Preventive Controls Review
  • • Food Safety Impact Assessment
  • • Compliance Gap Assessment
  • • Regulatory Recommendations
Updated Documentation
  • • Revised Food Safety Plan
  • • Updated Hazard Analysis
  • • Updated Preventive Controls
  • • Updated Procedures
  • • Updated Forms
  • • Revision History Log
Monthly Deliverables
  • • Monthly Activity Report
  • • Compliance Recommendations
  • • Process Change Summary
  • • Meeting Minutes
  • • Action Item Tracker
Industries We Support
Our Process Change Evaluation 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?

Operational changes should never be implemented without considering their impact on food safety. Our Remote PCQI Service helps your organization evaluate changes before they become regulatory or operational risks.

Companies choose PCQIServices.com because we provide:
  • • Experienced Preventive Controls Qualified Individuals (PCQIs)
  • • FDA-focused change management expertise
  • • Practical, facility-specific recommendations
  • • Rapid review of operational changes
  • • Affordable monthly service
  • • Remote nationwide and international support
  • • Ongoing compliance guidance

Our objective is to help your organization confidently implement operational improvements while maintaining a current, effective, and FDA-compliant Food Safety Plan.

Frequently Asked Questions

What types of changes require evaluation? Examples include:
  • • New products
  • • New ingredients
  • • New suppliers
  • • Equipment changes
  • • Process modifications
  • • Packaging changes
  • • Facility expansions
  • • Label revisions
  • • New manufacturing technologies
Does every process change require a Food Safety Plan update? Not every change requires revisions. However, every significant change should be evaluated by a Preventive Controls Qualified Individual (PCQI) to determine whether the Hazard Analysis, Preventive Controls, or other Food Safety Plan components should be updated. Who should evaluate process changes? Process changes should be evaluated by, or under the oversight of, a Preventive Controls Qualified Individual (PCQI) to determine their impact on food safety and regulatory compliance. Can process changes be evaluated remotely? Yes. Our Remote PCQI Services allow us to evaluate process changes through virtual meetings, document reviews, process flow analysis, engineering documentation, product information, and collaboration with your food safety team. How much does your Process Change Evaluation service cost? Our Remote PCQI Service is $750 per month and includes up to 25 hours of professional support for process change evaluations, Food Safety Plan updates, regulatory consultation, and ongoing compliance guidance.

FDA Regulation

21 CFR §117.170 – Food Safety Plan Reanalysis Under 21 CFR §117.170, facilities must reanalyze their Food Safety Plan whenever a significant change in activities creates a reasonable potential for a new hazard or a significant increase in a previously identified hazard, or when a preventive control may no longer be adequate.
Process change evaluations help determine whether updates are needed to:
  • • Hazard Analysis
  • • Preventive Controls
  • • Monitoring Procedures
  • • Verification Activities
  • • Validation Documentation
  • • Supporting Food Safety Plan documentation
Our Remote PCQI Process Change Evaluation Service provides a structured approach to change management, helping your organization maintain compliance while implementing operational improvements.

Request a Free Consultation

Planning to introduce a new product, supplier, ingredient, process, or equipment?

Partner with PCQIServices.com for professional Remote PCQI Process Change Evaluation Services and ensure every operational change is properly assessed before implementation.

Remote PCQI Service

$750 Per Month

Up to 25 Hours of Professional PCQI Support
➜ FDA-Compliant Process Change Evaluations
➜ Hazard Analysis and Preventive Controls Assessments
➜ Experienced Preventive Controls Qualified Individuals (PCQIs)
➜ Nationwide & International Remote Service
Contact us today to schedule your free consultation and confidently manage operational changes while maintaining FDA compliance.

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

Need Expert PCQI Support?

Partner with our experienced Preventive Controls Qualified Individuals (PCQIs) for practical FDA compliance guidance, documentation support, Food Safety Plan development, regulatory consulting, and ongoing compliance services tailored to your operation.