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Hazard analysis review

Every step checked for completeness and every significance decision tested for the reasoning behind it, with replacement wording supplied.

What is a hazard analysis review?

A hazard analysis review examines whether the hazards at each process step have been identified completely, whether the significance decision for each is justified in writing, and whether the control measures assigned follow from that reasoning. It is the part of a HACCP system auditors probe hardest, because a plan can reach entirely correct conclusions and still fail on the absence of reasoning behind them.

The distinction that decides the outcome is between a conclusion and a judgement. A conclusion states that a hazard is significant. A judgement shows the likelihood and the severity that led there. Auditors test the second, which is why a plan with entirely correct conclusions can still attract findings across the analysis.

Summary

Completeness, reasoning, boundary and control logic checked step by step, with wording you can put straight into the document. Delivered remotely, in any language, quoted on scope.

Hazard analysis review at a glance

Assessed against
Codex principles and your own standard
Standards
BRCGS, IFS, FSSC 22000, ISO 22000, SQF, customer codes
Covers
Biological, chemical, physical and allergen hazards
Output
Findings and replacement reasoning per hazard
Delivery
Remote
Scope
The hazard analysis, not the full plan
Coverage
Worldwide
Languages
Any language, including English, Spanish, French, German, Italian and Portuguese

What the review tests

Eight checks applied at every process step, with the failure each one catches most often.

CheckWhat it establishesCommon failure
Step completenessEvery process step present, including intake, storage, rework, holding and dispatch.Steps omitted because nothing happens to product there, which is where hazards hide.
Hazard identificationBiological, chemical, physical and allergen hazards considered at every step.Allergens treated as a separate exercise instead of a hazard within the analysis.
Source of each hazardWhether the hazard is introduced, increased or fails to be controlled at that step.The same hazard listed at every step with no statement of what the step does to it.
Likelihood and severityBoth assessed and both recorded, with the basis for each stated.A significance verdict written as a conclusion with no reasoning behind it.
Significance decisionA defensible judgement following from the likelihood and severity recorded.Significance assigned to match the controls already in place.
Control measure logicThe control assigned genuinely addresses the hazard identified at that step.A control that manages a different hazard, or one that belongs in a prerequisite programme.
Prerequisite boundaryHazards controlled by prerequisite programmes distinguished from those needing a CCP.Prerequisite matters escalated to CCPs, producing a plan nobody can monitor.
Supporting evidenceScientific or regulatory basis cited where a hazard is dismissed or a limit set.Hazards dismissed on experience with nothing recorded to support it.

What recorded reasoning looks like

The difference between a hazard analysis that holds and one that attracts findings is visible in a single entry.

Entry typeHow it readsVerdict
Conclusion onlySignificant. Controlled at step 7.Fails. Nothing shows how the judgement was reached, so an auditor cannot test it.
Reasoning recordedVegetative pathogens may be present on incoming material and this step provides no reduction. Severity high, likelihood moderate without control. Significant.Holds. Likelihood and severity are stated and the conclusion follows from them.
Dismissal without basisNot significant. Never had a problem.Fails. Absence of incidents is not evidence a hazard was assessed.
Dismissal with basisWater activity below the level supporting growth, supported by product data. Not significant.Holds. The dismissal rests on a property of the product that can be checked.

Where hazard analyses fail

Eight failures, and the first is a frequent source of findings on its own.

What you receive

Replacement reasoning is supplied per hazard, so the analysis can be corrected directly.

ElementWhat it covers
Step by step findingsEach process step marked sound, weak or missing, with the reason stated.
Completeness gapsSteps and hazards absent from the analysis, identified explicitly.
Reasoning assessmentWhere significance is stated without the likelihood and severity behind it.
Replacement wordingWritten reasoning you can put into the analysis directly, per hazard.
Boundary correctionsHazards sitting at the wrong level, whether escalated to a CCP or left in a prerequisite.
Evidence needsWhere a dismissal or a limit needs a scientific or regulatory citation to stand.
Priority orderFindings ordered by the consequence each would carry at audit.
Change triggersThe events that should prompt a reassessment, so the analysis stays current.

Who a hazard analysis review is for

Food manufacturers, processors, packers and catering businesses operating a HACCP based system. It suits any business whose audit findings concentrate in the analysis instead of being spread across the plan.

An auditor has raised findings across your hazard analysis.

Significance decisions are recorded with no reasoning behind them.

You have more CCPs than the process warrants.

Allergens are managed outside the analysis entirely.

The analysis was inherited and nobody can defend it.

A new ingredient, line or supplier has been introduced.

The analysis came from a template and was never adapted.

You are moving to a new standard and want the analysis checked first.

How the review is carried out

  • 1

    Documents in

    You send the hazard analysis, the flow diagram, product descriptions and the standard you work to.

  • 2

    Flow check

    The flow diagram is checked against the operation, since an analysis built on a wrong flow is wrong throughout.

  • 3

    Completeness

    Every step is checked for presence, and every hazard type is checked at each step.

  • 4

    Reasoning

    Each significance decision is tested for whether likelihood and severity are recorded and whether the conclusion follows.

  • 5

    Boundary and control

    Hazards sitting at the wrong level are identified, and control measures are checked against the hazards they claim to address.

  • 6

    Wording

    Replacement reasoning is supplied per hazard, in priority order by audit consequence.

Not included

Building an analysis from scratch. Where there is little to review, HACCP plan development is the service that applies.

Validation studies. Where a control measure needs evidence that it works on your equipment with your product, the review says what study is needed.

The wider plan. CCP determination, critical limits, monitoring and verification are covered by a HACCP plan review.

What a hazard analysis review costs

Every review is quoted against its own scope. A six step process with one product and a forty step process across a product range are very different pieces of work. These factors set the price.

Number of product families

Number of process steps

Hazard categories in scope

What this service is assessed against

These are the primary sources this work is built on. Where a market you sell into has its own requirement, that takes precedence and we assess against it.

CXC 1-1969, General Principles of Food Hygiene
The international reference for prerequisite programmes and for the seven HACCP principles. Codex Alimentarius
21 CFR Part 117, preventive controls for human food
The FSMA hazard analysis and risk based preventive controls requirements, including validation and verification. eCFR
Regulation (EC) No 852/2004 on the hygiene of foodstuffs
The general hygiene requirements and the duty to operate procedures based on HACCP principles. EUR-Lex
ISO 22000:2018, food safety management systems
The management system requirements, including the distinction between operational prerequisite programmes and critical control points. ISO
BRCGS, IFS Food, FSSC 22000 and SQF published requirements
The clause your certification body audits against, which differs between schemes and between issues. BRCGS

Hazard analysis terms

Hazard analysis
The process of collecting and evaluating information on hazards to decide which are significant and must be addressed in the food safety plan.
Significant hazard
A hazard reasonably likely to occur and cause illness or injury without control, requiring a control measure.
Likelihood
How probable it is that the hazard occurs at that step in the absence of control.
Severity
The seriousness of the consequence if the hazard reaches the consumer.
Control measure
An action or activity used to prevent, eliminate or reduce a significant hazard to an acceptable level.
Prerequisite programme
A basic condition or activity necessary to maintain a hygienic environment, controlling hazards across the operation instead of at one step.
Critical control point
A step at which control is essential to prevent, eliminate or reduce a significant hazard to an acceptable level.
Codex Alimentarius
The international food standards body whose HACCP principles underpin the major certification schemes.

Hazard analysis questions

It is the process of identifying the biological, chemical, physical and allergen hazards at every process step, assessing how likely each is and how serious it would be, and deciding which are significant enough to need a control measure. It is the foundation of a HACCP plan, and everything after it depends on it being right.

Reasoning. A significance decision recorded as a bare conclusion gives an auditor nothing to test, so the clause is raised even where the conclusion is correct. What holds up is a record showing the likelihood and the severity considered, and a judgement that follows from them.

No. Absence of incidents may reflect low volume, good fortune or cases that were never traced back to you. A dismissal has to rest on something checkable, such as a product property, a process parameter or published evidence.

Yes. They move independently, and standards expect both to be visible. A hazard that is unlikely and catastrophic needs a different response from one that is frequent and mild, and a single combined score hides which is which.

A prerequisite programme controls hazards across the operation generally, such as cleaning or pest control. A CCP controls a specific significant hazard at a specific step, with a measurable critical limit and an immediate product decision when it is breached. Escalating prerequisite matters to CCPs produces a plan nobody can operate.

Yes, at every step where they could be introduced or fail to be controlled. Allergen management documented entirely outside the analysis is a common finding, because the analysis is where auditors look for it.

On a defined cycle, and immediately after any change to ingredients, process, equipment, packaging, supplier or intended use. An analysis untouched through a line change describes a process that no longer exists.

Every significant hazard does. Hazards assessed as not significant need the reasoning recorded and no control. The value of the analysis is in separating the two defensibly.

Scientific literature, regulatory guidance, industry codes, product data such as water activity or pH, and your own validation work. The point is that a reader can check the basis for a decision instead of taking it on trust.

A HACCP plan review covers the whole plan, including CCP determination, critical limits, monitoring, corrective action and verification. This review goes deeper into the hazard analysis alone. Businesses whose findings concentrate in the analysis should take this one.

The review supplies replacement wording for the reasoning, per hazard, which you put into your own document. Building a full analysis from scratch is HACCP plan development and is quoted separately.

Step by step findings marked sound, weak or missing, completeness gaps, an assessment of where reasoning is absent, replacement wording per hazard, boundary corrections where hazards sit at the wrong level, evidence needs, findings in priority order and the change triggers that should prompt a reassessment.

Who carries out this work

Confi Food assigns work by subject. HACCP, labelling, certification standards, regulatory compliance, supplier assurance and monitoring are separate disciplines, and each piece goes to someone who works in that area. Every deliverable is reviewed internally by a second specialist before it reaches you.

Our technical positions are built from primary sources, meaning the legislation, the competent authority, Codex Alimentarius, the certification scheme owner or the relevant standards body. We set out how that works in our technical review and editorial policy, and what happens at each stage of an engagement in how Confi Food works.

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Request a hazard analysis review

Send the analysis, the flow diagram and the standard you work to, and receive a written quote covering the scope, the deliverable and the price.