Remote PCQI Services for Corrective Action Procedures

FDA Corrective Action Procedure Development by a Preventive Controls Qualified Individual (PCQI)
Develop Corrective Action Procedures in Compliance with 21 CFR 117.150

When a preventive control is not properly implemented or fails to control a food safety hazard, your facility must respond quickly, consistently, and in accordance with FDA regulations. Under 21 CFR §117.150, facilities are required to establish and implement written Corrective Action Procedures and Corrections to address deviations, prevent unsafe food from entering commerce, and reduce the likelihood of recurrence.

At PCQIServices.com, we provide professional Remote PCQI Corrective Action Procedure Development Services to assist food manufacturers, processors, packers, warehouses, beverage companies, co-packers, contract manufacturers, ingredient suppliers, importers, and private label brands in establishing FDA-compliant corrective action programs.

Our experienced Preventive Controls Qualified Individuals (PCQIs) work remotely with your team to develop practical, facility-specific procedures that clearly define how deviations will be identified, investigated, corrected, documented, and verified.

What Are Corrective Actions and Corrections?

A Correction is an action taken to identify and immediately fix an isolated problem before it affects food safety.A Corrective Action goes beyond the immediate correction by investigating the root cause, evaluating affected product, implementing measures to prevent recurrence, and documenting the entire process.

A well-designed corrective action program helps your organization:

• Meet FDA requirements under 21 CFR §117.150
• Prevent unsafe food from reaching customers
• Reduce product recalls
• Improve operational consistency
• Strengthen continuous improvement
• Demonstrate compliance during FDA inspections

Why Hire a Remote PCQI?

Corrective Action Procedures should be practical, consistent, and aligned with your preventive controls and Food Safety Plan.

Our Remote PCQI Service helps your organization:

• Develop written corrective action procedures
• Differentiate corrections from corrective actions
• Establish product disposition procedures
• Define investigation requirements
• Document root cause analysis
• Prevent recurring deviations
• Improve FDA inspection readiness
• Maintain Food Safety Plan compliance

This service provides expert regulatory guidance without the expense of hiring a full-time food safety professional.

Monthly Remote PCQI Service

$750 Per Month

Includes Up to 25 Hours of Professional PCQI Support

Your monthly subscription includes:

• Corrective Action Procedure development
• Correction procedure development
• Root cause analysis guidance
• Product disposition procedures
• 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 Procedure Services

Corrective Action Procedure Development

Our Preventive Controls Qualified Individual (PCQI) develops written procedures that clearly define how your facility responds when preventive controls are not properly implemented or when deviations occur.

Procedures address:

• Identification of deviations
• Immediate response
• Product evaluation
• Product segregation
• Product disposition
• Root cause investigation
• Corrective action implementation
• Documentation requirements
• Follow-up activities

Product Evaluation and Disposition

When a deviation occurs, affected product must be evaluated to determine whether it is safe and suitable for distribution.

We help establish procedures for:

• Product hold
• Product quarantine
• Product evaluation
• Rework
• Reprocessing
• Product destruction
• Product release authorization
• Product disposition records

Root Cause Analysis

Understanding why a deviation occurred is essential to preventing recurrence. Our Preventive Controls Qualified Individual (PCQI) assists with documenting root cause investigations using practical problem-solving methods.

Root cause evaluations may consider:

• Personnel
• Equipment
• Materials
• Methods
• Environment
• Measurement systems
• Supplier issues
• Process variability

Prevent Recurrence

Corrective actions should address both the immediate issue and the underlying cause.

We help develop procedures for:

• Process improvements
• Equipment modifications
• Procedure updates
• Employee retraining
• Supplier corrective actions
• Preventive maintenance improvements
• Additional monitoring
• Verification of effectiveness

Corrective Action Documentation

Proper documentation is critical for FDA compliance.

We develop records for:

• Corrective Action Reports
• Product Evaluation Forms
• Product Disposition Records
• Root Cause Analysis Reports
• Investigation Records
• Follow-up Verification Records
• Trend Analysis Logs

Integration with Your Food Safety Plan

Corrective Action Procedures are integrated with:

• Hazard Analysis
• Preventive Controls
• Monitoring Procedures
• Verification Activities
• Validation Documentation
• Recordkeeping Requirements
• Recall Plan (when applicable)

This ensures your Food Safety Plan includes a complete and effective response system for deviations.

Deliverables

Your Corrective Action Procedure engagement may include:

Corrective Action Documentation

• Corrective Action Procedures
• Correction Procedures
• Root Cause Analysis Procedure
• Product Disposition Procedure
• Product Hold Procedure
• Investigation Procedure

Forms and Records

• Corrective Action Report
• Root Cause Analysis Form
• Product Evaluation Form
• Product Disposition Form
• Deviation Log
• Corrective Action Register
• Follow-up Verification Form

Monthly Deliverables

• Monthly Activity Report
• Compliance Recommendations
• Corrective Action Program Review
• Meeting Minutes
• Action Item Tracker

Industries We Support

Our Corrective Action Procedure Development 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 Procedures should do more than satisfy regulatory requirements—they should help your organization solve problems, protect consumers, and improve operational performance.

Companies choose PCQIServices.com because we provide:

• Experienced Preventive Controls Qualified Individuals (PCQIs)
• FDA-focused regulatory expertise
• Practical corrective action systems
• Facility-specific documentation
• Easy-to-use forms and records
• Affordable monthly service
• Remote nationwide and international support
• Ongoing compliance guidance

Our objective is to help your organization build a Corrective Action Program that supports both regulatory compliance and continuous improvement.

Frequently Asked Questions

What is the difference between a correction and a corrective action? A correction addresses an immediate issue, such as adjusting equipment or removing affected product. A corrective action identifies the root cause, determines product disposition, implements measures to prevent recurrence, and documents the complete process. When are corrective action procedures required? Corrective action procedures are required whenever preventive controls are not properly implemented, monitoring identifies a deviation, or other situations described in your Food Safety Plan require a documented response under 21 CFR §117.150. What should a corrective action procedure include? A corrective action procedure should define:

• How deviations are identified
• Immediate actions to control affected product
• Product evaluation and disposition
• Root cause investigation
• Preventive measures
• Documentation requirements
• Verification of effectiveness

Can corrective action procedures be developed remotely? Yes. Our Remote PCQI Services allow us to develop facility-specific corrective action procedures through document review, virtual meetings, process evaluations, and collaboration with your food safety team. How much does your Corrective Action Procedure Development service cost? Our Remote PCQI Service is $750 per month and includes up to 25 hours of professional support for corrective action procedures, Food Safety Plan documentation, and regulatory consultation.

FDA Regulation

21 CFR §117.150 – Corrective Actions and Corrections Under 21 CFR §117.150, facilities must establish and implement written corrective action procedures that describe the actions to be taken when preventive controls are not properly implemented or when deviations occur.

Corrective action procedures should include:

• Evaluation of affected food
• Correction of the problem
• Prevention of recurrence
• Appropriate documentation

Our Remote PCQI Corrective Action Procedure Development Service helps your organization develop practical, FDA-compliant procedures that support effective food safety management and inspection readiness.

Request a Free Consultation

Need assistance developing FDA-compliant corrective action procedures? Partner with PCQIServices.com for professional Remote PCQI Corrective Action Procedure Development Services and receive practical, facility-specific guidance from experienced Preventive Controls Qualified Individuals (PCQIs).

Remote PCQI Service

$750 Per Month

Up to 25 Hours of Professional PCQI Support

➜ FDA-Compliant Corrective Action Procedures
➜ Root Cause Analysis and Product Disposition Guidance
➜ 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 effective corrective action procedures.

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