Remote PCQI Services for Hazard Analysis

FDA Hazard Analysis Services by a Preventive Controls Qualified Individual (PCQI)
Identify Known or Reasonably Foreseeable Hazards in Compliance with 21 CFR 117.130

A comprehensive Hazard Analysis is the foundation of every FDA-compliant Food Safety Plan. Under the Food Safety Modernization Act (FSMA), facilities subject to 21 CFR Part 117 must identify and evaluate all known or reasonably foreseeable biological, chemical (including food allergens), and physical hazards to determine whether preventive controls are required.

At PCQIServices.com, we provide professional Remote PCQI Hazard Analysis Services to help food manufacturers, processors, packers, warehouses, importers, co-packers, and private label companies comply with 21 CFR §117.130.

Our experienced Preventive Controls Qualified Individuals (PCQIs) work remotely with your team to perform a facility-specific Hazard Analysis that supports FDA compliance and strengthens your food safety management system.

What Is a Hazard Analysis?

A Hazard Analysis is a systematic evaluation of the hazards that may occur during the manufacturing, processing, packing, or holding of food. The purpose is to determine which hazards require preventive controls to significantly minimize or prevent food safety risks.

A properly documented Hazard Analysis helps facilities:

• Meet FDA FSMA requirements
• Identify food safety risks
• Determine necessary preventive controls
• Improve product safety
• Prepare for FDA inspections
• Reduce the likelihood of recalls and regulatory actions

Monthly Remote PCQI Service

$750 Per Month

Includes Up to 25 Hours of Professional PCQI Support

Our monthly subscription provides access to an experienced Preventive Controls Qualified Individual (PCQI) without the expense of hiring a full-time food safety professional.

Your monthly service includes:

• Hazard Analysis development
• Hazard Analysis review and updates
• Food Safety Plan support
• FDA regulatory guidance
• Virtual meetings
• Document review
• Email and telephone support
• Compliance recommendations
• Monthly activity reporting

Unused hours do not carry over to the following month.

Scope of Hazard Analysis Services

Hazard Identification

Our Preventive Controls Qualified Individual (PCQI) evaluates your facility, products, ingredients, equipment, processes, and intended use to identify known or reasonably foreseeable hazards.

Hazards evaluated include:

Biological Hazards

Examples include:

• Pathogenic bacteria
• Viruses
• Parasites
• Yeasts and molds
• Environmental pathogens

Chemical Hazards

We evaluate hazards such as:

• Food allergens
• Undeclared allergens
• Naturally occurring toxins
• Chemical contaminants
• Pesticide residues
• Heavy metals
• Drug residues
• Processing aids
• Cleaning chemicals
• Lubricants
• Economically motivated adulteration

Physical Hazards

Potential physical hazards include:

• Metal fragments
• Glass
• Plastic
• Wood
• Stones
• Packaging materials
• Personal items
• Equipment wear

Hazard Evaluation

After hazards are identified, our Preventive Controls Qualified Individual (PCQI) evaluates each hazard based on FDA requirements, including:

• Severity of illness or injury
• Probability of occurrence
• Nature of the hazard
• Manufacturing process
• Facility conditions
• Equipment design
• Ingredient risks
• Intended consumer
• Finished product characteristics
• Storage and distribution conditions

The evaluation determines whether a hazard requires one or more preventive controls.

Preventive Control Determination

Based on the Hazard Analysis, we determine whether preventive controls are necessary.

Potential preventive controls include:

• Process Preventive Controls
• Food Allergen Preventive Controls
• Sanitation Preventive Controls
• Supply-Chain Preventive Controls
• Other Preventive Controls

Each determination is documented with supporting rationale consistent with FDA expectations.

Deliverables

Depending on your facility and products, deliverables may include:

Hazard Analysis Documentation

• Facility-Specific Hazard Analysis
• Hazard Identification Matrix
• Hazard Evaluation Summary
• Hazard Decision Tree Documentation
• Preventive Control Determination
• Hazard Analysis Revision Log

Supporting Documentation

• Ingredient Risk Assessment
• Process Flow Review
• Product Description Review
• Intended Use Assessment
• Food Allergen Assessment
• Supplier Hazard Review
• Scientific References (when applicable)

Monthly Deliverables

• Monthly Activity Report
• Compliance Recommendations
• Hazard Analysis Updates
• Meeting Notes
• Action Item Tracker

Industries We Support

Our Hazard Analysis services support:

• Food Manufacturers
• Beverage Manufacturers
• Bakeries
• Dairy Facilities
• Seafood Processors
• Produce Operations
• Frozen Food Manufacturers
• Snack Food Companies
• Ingredient Suppliers
• Dietary Supplement Manufacturers
• Co-Packers
• Contract Manufacturers
• Food Warehouses
• Importers
• Private Label Brands

Why Choose PCQIServices.com?

Hazard Analysis is more than completing a form—it requires an understanding of FDA regulations, food science, manufacturing processes, and preventive controls.

Companies choose PCQIServices.com because we provide:

• Experienced Preventive Controls Qualified Individuals (PCQIs)
• FDA-focused regulatory expertise
• Practical, risk-based hazard evaluations
• Facility-specific documentation
• Ongoing remote support
• Affordable monthly service
• Responsive consultation

Our goal is to help you develop a Hazard Analysis that is technically sound, compliant, and practical for everyday operations.

Frequently Asked Questions

What is a Hazard Analysis under FSMA? A Hazard Analysis is the process of identifying and evaluating known or reasonably foreseeable biological, chemical (including food allergens), and physical hazards to determine whether preventive controls are required under 21 CFR §117.130. Who can conduct a Hazard Analysis? The Hazard Analysis must be conducted or overseen by a qualified Preventive Controls Qualified Individual (PCQI) as part of the Food Safety Plan. Does every food facility need a Hazard Analysis? Most FDA-registered food facilities subject to 21 CFR Part 117 must perform a documented Hazard Analysis as part of their Food Safety Plan. Can Hazard Analysis be completed remotely? Yes. Most Hazard Analysis activities can be completed remotely through document review, virtual meetings, facility information, process flow diagrams, and collaboration with your food safety team. What hazards must be evaluated? FDA regulations require evaluation of:

• Biological hazards
• Chemical hazards (including food allergens)
• Physical hazards

Facilities should also consider radiological hazards and economically motivated adulteration where applicable.

FDA Regulation

21 CFR §117.130 – Hazard Analysis Under 21 CFR §117.130, facilities must identify and evaluate known or reasonably foreseeable hazards to determine whether preventive controls are required.

The Hazard Analysis must consider:

• Biological hazards
• Chemical hazards, including allergens
• Physical hazards
• The severity of illness or injury if the hazard were to occur
• The probability that the hazard will occur in the absence of preventive controls

Our Remote PCQI Hazard Analysis Service is specifically designed to help facilities meet these FDA requirements while establishing a strong foundation for an effective Food Safety Plan.

Request a Free Consultation

Need assistance developing or reviewing your Hazard Analysis? Partner with PCQIServices.com for professional Remote PCQI Hazard Analysis Services and ensure your Food Safety Plan is built on a thorough, FDA-compliant risk assessment.

Monthly Service Fee

$750

Includes Up to 25 Hours of Professional PCQI Support

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