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HARA

Artifact

Topic overview

and : the concept-phase activity and resulting document that identifies hazards and derives safety goals and integrity targets.

Quick facts

StandardISO 26262-3
Produced inConcept phase
RatesSeverity, Exposure, Controllability per hazardous event
OutputASIL and safety goal per hazardous event
Basis forAll downstream safety requirements
Automotive analog ofPHA (rail), ISO 12100 risk assessment (machinery)

A HARA is a work product, not a standard. Under it evaluates hazardous events at vehicle level against severity, exposure, and controllability, producing safety goals with ratings; under machinery standards the analogous activity is the risk assessment, and rail programs perform preliminary hazard analysis feeding the safety case.

Whatever the domain, the HARA is the document that converts an open-ended question, what can go wrong, into a bounded engineering contract: this list of safety goals, at these integrity levels.

A competent HARA works from defined operational situations and operating modes, not just component failures. The same malfunction, unintended acceleration for example, carries very different risk in a parking lot versus a highway merge, and the HARA must evaluate the credible combinations rather than only the worst case or only the typical case.

Foreseeable misuse belongs in scope; deliberate sabotage generally does not.

Because every downstream safety requirement traces to it, the HARA is audited heavily during certification, and changes to it late in a program ripple through the entire requirements tree. Mature organizations treat the HARA as a living document under configuration control, revisited whenever the system's functions, operating environment, or usage assumptions change.

The case for HARA

The HARA is where a program's safety scope and cost are actually decided. Every integrity target that drives architecture, staffing, and test volume originates here, so an unexamined pessimistic HARA silently inflates the budget while an optimistic one produces a product that fails assessment or harms someone.

It is also the first document a certification body, customer safety team, or post-incident investigator reads; a thin or obviously templated HARA undermines confidence in everything built on top of it.

HARA in practice

Safety lifecycle

ConceptHARA produced here from the item definition
RequirementsSafety goals refined into FSR and TSR
DesignArchitecture allocates requirements
ImplementationHardware and software realization
V&VTesting traced back to safety goals
AssessmentHARA reviewed as safety case foundation

Where teams get HARA wrong

Rating hazards only in nominal operation and missing maintenance, commissioning, and degraded modes.
Copying a HARA from a previous product whose operating environment differed.
Justifying low ratings with mitigation credit for safety functions the HARA itself is supposed to motivate, a circular argument assessors reject.
Leaving parameter choices unjustified so ratings look arbitrary.
Freezing the HARA at kickoff and never reconciling it with feature changes made during development.

Standards related to HARA

ISO 26262 Road Vehicles - Functional Safety

ISO 26262 sets the requirements that HARA work has to satisfy: automotive functional safety standard defining asil levels and the automotive safety lifecycle.

ISO 12100 Safety of Machinery - Risk Assessment and Risk Reduction

Assessors evaluate HARA against ISO 12100, the foundational machinery safety standard establishing risk assessment methodology and the hierarchy of risk reduction.

HARA ownership and review

AspectDetail
Produced bySystem safety engineer with domain experts
InputsItem definition, operating scenarios, field data
OutputsHazardous events, S/E/C ratings, ASILs, safety goals
Reviewed byIndependent reviewer; assessor at confirmation review
Updated whenItem definition or usage assumptions change

HARA by industry

Autonomous Systems

Autonomous Systems programs lean on HARA because the sector covers autonomous mobile equipment, off-highway autonomy, and driverless platforms.

Industrial Machinery

Industrial Machinery programs lean on HARA because the sector covers fixed and mobile machinery, packaging lines, and manufacturing equipment.

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HARA: related terms

How each connects to HARA:

Functional Safety Concept

Functional Safety appears in the same lifecycle work as HARA and is usually produced or reviewed alongside it.

ASIL Measure

ASIL appears in the same lifecycle work as HARA and is usually produced or reviewed alongside it.

Risk Assessment Activity

Risk Assessment appears in the same lifecycle work as HARA and is usually produced or reviewed alongside it.

Hierarchy of Risk Reduction Concept

Hierarchy of Risk Reduction is governed by ISO 12100 as well, which is why the two show up together in audits.

FMEA Artifact

Both HARA and FMEA sit under ISO 26262, so evidence for one usually references the other.

FMEDA Artifact

ISO 26262 connects the two: HARA and FMEDA are assessed against the same lifecycle.

CE Marking Process

ISO 12100 connects the two: HARA and CE Marking are assessed against the same lifecycle.

Functional Safety Plan Artifact

Both HARA and Functional Safety Plan sit under ISO 26262, so evidence for one usually references the other.

Safety Manager Job title

ISO 26262 connects the two: HARA and Safety Manager are assessed against the same lifecycle.

V-Model Concept

ISO 26262 connects the two: HARA and V-Model are assessed against the same lifecycle.

Functional Safety Assessment (FSA) Activity

Both HARA and Functional Safety Assessment sit under ISO 26262, so evidence for one usually references the other.

Functional Safety Audit Activity

ISO 26262 connects the two: HARA and Functional Safety Audit are assessed against the same lifecycle.

Every CSA service, through the HARA lens

How each service connects to HARA.

Gap Analysis
Rapid Safety Diagnostic

Rapid Safety Diagnostic shows where your HARA evidence stands before an assessor looks: a one-week expert review of your product and safety posture producing a prioritized findings memo and recommended next steps.

Onsite Safety Review

If HARA is the question, Onsite Safety Review is the fastest honest answer - two days onsite with your team and equipment: walkdowns, interviews, and a readout of observed gaps against applicable standards.

Functional Safety Gap Analysis & Roadmap

If HARA is the question, Functional Safety Gap Analysis & Roadmap is the fastest honest answer - structured assessment of your current safety lifecycle and evidence against target standards, delivering a certification roadmap with effort estimates.

Safety Engineering
Risk Assessment

In Risk Assessment, CSA engineers execute HARA work inside your program - a complete iso 12100 or sector-appropriate risk assessment with one stakeholder review cycle, producing the documented basis for your safety concept.

SMS Stand-Up

SMS Stand-Up turns HARA from a requirement into reviewed, assessor-ready evidence.

Product Certification Management

Product Certification Management turns HARA from a requirement into reviewed, assessor-ready evidence.

Safety Program & Certification Support

Safety Program & Certification Support produces and defends the work products where HARA lives: embedded csa engineers execute safety lifecycle work products inside your program at the cadence your schedule demands.

Safety Case Maintenance

In Safety Case Maintenance, CSA engineers execute HARA work inside your program - ongoing stewardship of your certified safety case: change impact analysis, evidence updates, and periodic assessor reviews.

Embedded Engineering Program

In Embedded Engineering Program, CSA engineers execute HARA work inside your program - dedicated csa functional safety engineers embedded in your team, managed by csa, delivering inside your development process.

Training
Custom Safety Training

Custom Safety Training covers HARA with worked examples from real certification programs.

Private Safety Training

Teams leave Private Safety Training able to apply HARA on their own program, not just define it.

Advisory
On-Demand Advisory

When a HARA question stalls a decision, On-Demand Advisory gets an expert answer on your cadence.

Fractional Safety Manager

Fractional Safety Manager gives you a senior sounding board for HARA decisions - a senior csa safety manager guides your certification strategy and program management on a part-time, ongoing basis.