Remote PCQI Services for Corrective Action Record Review
FDA Corrective Action Record Review by a Preventive Controls Qualified Individual (PCQI)
Review Corrective Action Records in Compliance with 21 CFR 117.165
When a preventive control deviation occurs, documenting a corrective action is only the first step. Under 21 CFR §117.165, facilities must review corrective action records to verify that appropriate actions were taken, affected food was properly evaluated, root causes were addressed, and preventive measures were implemented to reduce the likelihood of recurrence.At PCQIServices.com, we provide professional Remote PCQI Corrective Action Record Review Services to assist food manufacturers, processors, packers, warehouses, beverage companies, ingredient suppliers, co-packers, contract manufacturers, importers, and private label brands in maintaining FDA-compliant corrective action documentation.
Our experienced Preventive Controls Qualified Individuals (PCQIs) remotely review corrective action records to evaluate the effectiveness of the response, verify regulatory compliance, identify recurring issues, and provide recommendations for continuous improvement.
Why Corrective Action Record Reviews Matter
Corrective action records demonstrate how your organization responds when preventive controls are not properly implemented or when deviations occur. Reviewing these records helps confirm that the documented response effectively addressed both the immediate issue and the underlying cause.
An effective corrective action record review program helps your organization:
- • Meet FDA requirements under 21 CFR §117.165
- • Verify that corrective actions were appropriate
- • Confirm affected product was evaluated and dispositioned correctly
- • Reduce repeat deviations
- • Improve operational consistency
- • Strengthen FDA inspection readiness
- • Support continuous improvement
Why Hire a Remote PCQI?
FDA regulations require that corrective action records associated with preventive controls be reviewed by, or under the oversight of, a Preventive Controls Qualified Individual (PCQI) within established regulatory timeframes.
Our Remote PCQI Service provides expert oversight without the cost of employing a full-time food safety professional.
We help organizations:
- • Review corrective action records
- • Evaluate root cause analyses
- • Confirm product disposition decisions
- • Assess preventive measures
- • Review verification of effectiveness
- • Identify recurring process failures
- • Improve Food Safety Plan implementation
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:
- • Corrective Action Record Review
- • Root Cause Analysis Review
- • Product Disposition Review
- • Compliance Evaluations
- • Food Safety Plan 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 Corrective Action Record Review Services
Corrective Action Record Review
Our Preventive Controls Qualified Individual (PCQI) reviews corrective action documentation to verify that:
- • The deviation was properly documented
- • Immediate corrections were completed
- • Corrective actions were appropriate
- • Root cause investigations were completed
- • Preventive measures were implemented
- • Records were complete and accurate
- • Responsible personnel completed required actions
- • Required approvals were obtained
Product Evaluation Review
When a preventive control deviation affects food safety, affected product must be evaluated before release.
Our review evaluates:
- • Product hold decisions
- • Product segregation
- • Product evaluation
- • Product disposition
- • Rework documentation
- • Reprocessing decisions
- • Product destruction
- • Product release authorization
Root Cause Analysis Review
Our Preventive Controls Qualified Individual (PCQI) evaluates whether the investigation adequately identified the underlying cause of the deviation.
Root cause reviews may include:
- • Equipment failures
- • Employee performance
- • Training deficiencies
- • Supplier-related issues
- • Material variability
- • Environmental conditions
- • Process failures
- • Procedural weaknesses
Preventive Measure Review
Corrective actions should reduce the likelihood of recurrence.
Our review verifies implementation of:
- • Procedure revisions
- • Equipment improvements
- • Employee retraining
- • Supplier corrective actions
- • Additional monitoring
- • Preventive maintenance
- • Process modifications
- • Verification activities
Effectiveness Verification
Implementing a corrective action is only part of the process. The facility should also confirm that the action effectively resolved the problem.
Our review evaluates:
- • Follow-up monitoring
- • Verification records
- • Trend analysis
- • Repeat deviations
- • Process performance
- • Ongoing effectiveness
Documentation Review
Accurate documentation is essential during FDA inspections.
Our Preventive Controls Qualified Individual (PCQI) evaluates:
- • Completeness
- • Accuracy
- • Dates
- • Signatures
- • Timeliness
- • Supporting evidence
- • Regulatory consistency
- • Record retention
Food Safety Plan Integration
Corrective Action Record Reviews support:
- • Hazard Analysis
- • Preventive Controls
- • Monitoring Procedures
- • Verification Activities
- • Validation Documentation
- • Food Safety Plan Reanalysis
- • Continuous Improvement
Deliverables
Your Corrective Action Record Review engagement may include:
Review Documentation
- • Corrective Action Record Review Report
- • Root Cause Evaluation Summary
- • Product Disposition Review
- • Corrective Action Effectiveness Assessment
- • Compliance Gap Assessment
- • Trend Analysis Report
Supporting Documentation
- • Corrective Action Recommendations
- • Documentation Improvement Recommendations
- • Recurring Deviation Analysis
- • Regulatory Compliance Summary
- • Food Safety Plan Update Recommendations
Monthly Deliverables
- • Monthly Activity Report
- • Compliance Recommendations
- • Corrective Action Review Summary
- • Meeting Minutes
- • Action Item Tracker
Industries We Support
Our Corrective Action Record Review 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?
Corrective action records are closely reviewed during FDA inspections because they demonstrate how your organization responds to food safety issues and whether preventive controls remain effective.
Companies choose PCQIServices.com because we provide:
- • Experienced Preventive Controls Qualified Individuals (PCQIs)
- • FDA-focused corrective action expertise
- • Practical compliance recommendations
- • Facility-specific documentation support
- • Affordable monthly service
- • Remote nationwide and international support
- • Ongoing regulatory guidance
Frequently Asked Questions
Why should corrective action records be reviewed?
Corrective action records should be reviewed to verify that the response was appropriate, affected product was properly evaluated, the root cause was addressed, and measures were implemented to prevent recurrence.
Who reviews corrective action records?
Corrective action records associated with preventive controls should be reviewed by, or under the oversight of, a Preventive Controls Qualified Individual (PCQI) within the timeframes required by 21 CFR §117.165.
What should a corrective action record include?
A complete corrective action record typically includes:
- • Description of the deviation
- • Immediate correction
- • Product evaluation and disposition
- • Root cause analysis
- • Corrective action taken
- • Preventive measures
- • Verification of effectiveness
- • Required approvals
FDA Regulation
21 CFR §117.165 – Verification
Under 21 CFR §117.165, corrective action records associated with preventive controls must be reviewed to verify that appropriate actions were taken, affected food was properly evaluated, documentation is complete, and the Food Safety Plan continues to operate effectively.
Verification activities include reviewing:
- • Corrective action records
- • Evaluation of affected food
- • Completeness of documentation
- • Ongoing effectiveness of the Food Safety Plan
Request a Free Consultation
Need a qualified PCQI to review your corrective action records?
Partner with PCQIServices.com for professional Remote PCQI Corrective Action Record Review Services and receive expert oversight of your corrective action program and Food Safety Plan.
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 Corrective Action Record Reviews
➜ Root Cause and Product Disposition Oversight
➜ Experienced Preventive Controls Qualified Individuals (PCQIs)
➜ Nationwide & International Remote Service
➜ Root Cause and Product Disposition Oversight
➜ Experienced Preventive Controls Qualified Individuals (PCQIs)
➜ Nationwide & International Remote Service
Contact us today to schedule your free consultation and strengthen your Food Safety Plan through effective corrective action record reviews.
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
