Definition

Hazard analysis is the systematic process of identifying potential food safety hazards that could be reasonably likely to occur in your manufacturing process, and evaluating each hazard's severity and the probability that it will actually cause harm without controls in place.

The output of a hazard analysis is a documented determination: which hazards require a preventive control or critical control point, and which do not, along with the reasoning behind each decision.

It is not a one-time exercise. It is a living document that must reflect your current products, processes, suppliers, and facility conditions.

Where It Fits

Managing hazard analysis documentation in paper binders and spreadsheets creates real operational risk. When a process changes, updating paper-based documentation across multiple programs, HACCP plans, SOPs, training materials, supplier specifications, requires manual coordination that is easy to miss.

Digital food safety management platforms support hazard analysis program management by centralizing documentation, enabling structured record-keeping, and connecting hazard analysis records to related programs including preventive controls, CAPA workflows, and pre-shipment reviews.

SafetyChain's Food Safety Programs capability supports the digitization and organization of food safety documentation, including HACCP monitoring records, CCP verification workflows, pre-operational checks, and CAPA management. These are not designed to automate the judgment-based work of hazard analysis itself, which requires human expertise. They are designed to ensure that the documentation supporting your hazard analysis decisions is organized, complete, and retrievable when it matters, whether during a routine operational review or an unannounced audit.

Customers have used SafetyChain to significantly reduce the time required to prepare for audits and reassess HACCP programs. JBS USA, for example, reduced HACCP reassessment time from more than five days of work per facility to approximately six hours, an 85% reduction, by accessing structured electronic CCP data rather than pulling and re-entering paper records. That time savings allowed FSQA managers to return meaningful working hours to proactive food safety activities rather than administrative reconstruction.

FAQs

Compliance Requirements

FSMA: The Preventive Controls Rule (21 CFR Part 117)

Under the FDA's Food Safety Modernization Act, virtually every food manufacturing facility subject to registration is required to conduct and document a hazard analysis. The specific requirement is found in 21 CFR Part 117, Subpart C, "Hazard Analysis and Risk-Based Preventive Controls for Human Food."

The regulation requires facilities to:

Identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured
Determine which identified hazards require a preventive control
Document the hazard analysis in writing

The hazard analysis must be conducted by or under the oversight of a Preventive Controls Qualified Individual (PCQI), a role with defined training and competency requirements under FSMA.

A documented hazard analysis is not optional. Under FSMA, the determination that a hazard does not require a preventive control must itself be documented, along with the reasoning. Silence is not a valid answer.

For facilities that rely on a trading partner or customer to control a hazard (rather than implementing their own control), 21 CFR § 117.136 establishes the specific conditions and documentation requirements that must be met to support that determination.

USDA/FSIS: 9 CFR Part 417

For establishments producing meat, poultry, and processed egg products regulated by USDA's Food Safety and Inspection Service, hazard analysis requirements are established under 9 CFR Part 417, the HACCP regulation for FSIS-inspected facilities. These facilities must:

Conduct a hazard analysis to identify food safety hazards that are reasonably likely to occur
Identify critical control points (CCPs) for each hazard that requires control
Document the hazard analysis in writing prior to implementing their HACCP system

FSIS-regulated facilities operate under a different regulatory framework than FDA-regulated facilities, but the core obligation, a written, documented hazard analysis, is the same.

Foreign Supplier Verification: 21 CFR Part 1, Subpart L

If your facility imports food ingredients or finished products, hazard analysis obligations extend to your supply chain. The FSMA Foreign Supplier Verification Programs (FSVP) rule, codified at 21 CFR Part 1, Subpart L, requires importers to conduct a hazard analysis for each food type and each foreign supplier. This analysis must evaluate biological, chemical, and physical hazards before the food enters your facility.

GFSI-Benchmarked Schemes (SQF, BRC, FSSC 22000)

Facilities pursuing certification under GFSI-recognized schemes, including SQF, BRCGS, and FSSC 22000, are required to conduct and maintain hazard analyses as part of their food safety management systems. While the specific clause requirements vary by scheme, the expectation is consistent: hazard analysis must be documented, current, and linked to your control measures. Auditors under these schemes review hazard analysis documentation and will issue nonconformances when the analysis is incomplete, outdated, or disconnected from current process conditions.

Related Terms & Content

Understanding hazard analysis is easier with clear definitions of the concepts connected to it. Critical Control Point (CCP): A step in the process where a control measure can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level. CCPs are identified through the hazard analysis process. Preventive Controls: Risk-based, reasonably appropriate procedures, practices, and processes required under FSMA to significantly minimize or prevent the occurrence of identified hazards. Hazard analysis determines which hazards require a preventive control. Hazard Analysis and Critical Control Points (HACCP): A systematic preventive approach to food safety that identifies physical, chemical, and biological hazards and establishes controls at critical points in the process. Hazard analysis is Principle 1 of HACCP. Corrective and Preventive Actions (CAPA): The formal process for identifying a nonconformance, determining its root cause, implementing a correction, and taking preventive action to reduce the likelihood of recurrence. Effective CAPA programs connect findings back to the hazard analysis and food safety plan. Preventive Controls Qualified Individual (PCQI): Under FSMA, the individual responsible for overseeing the development, implementation, and maintenance of the food safety plan, including the hazard analysis. The PCQI must have the education, training, or experience necessary to perform this function. Food Safety Plan: The written document required under FSMA's Preventive Controls Rule that includes the hazard analysis, preventive controls, supply chain program, recall plan, monitoring procedures, corrective action procedures, and verification activities.

Hazard Analysis