Functional Safety SERVICE / 07

Functional Safety Engineering:
From Hazard to Safety Case

ISO 26262 · IEC 61508 · ARP 4754 Compliance Across the Full Development Lifecycle

Functional safety engineering ensures that safety-critical systems behave correctly in response to faults and failures. Our team supports the complete safety lifecycle — from standards selection and HARA through requirements modelling, FMEA/FMEDA, FTA, and safety V&V — delivering the analysis, work products, and evidence needed to achieve certification and product release.

ISO 26262IEC 61508HARAFMEA / FMEDAFault Tree AnalysisSafety V&V

What We Deliver

Safety Lifecycle Support,
Backed by Simulation Expertise

Our functional safety team combines deep standards expertise with simulation-driven analysis to support safety-critical development across automotive, aerospace, and industrial domains. We work alongside system, hardware, and software teams to integrate safety activities into the development process — not bolt them on at the end.

Whether you need support for a first ISO 26262 programme or independent assessment for a complex ASIL D item, our engineers bring the rigour, tooling, and domain knowledge to deliver a credible, complete safety case.

7 Safety Analysis Types
ASIL D Highest Integrity Level
3 Major Standards Covered

Key Problems We Solve

Uncertainty about which safety standard applies
HARA and ASIL ratings inconsistent across teams
FMEA and FTA results not linked to safety requirements
Diagnostic coverage gaps discovered late in development
Safety case incomplete at product release

7 Analysis Types

Our Functional Safety Capabilities

Select an analysis type to explore the methodology, deliverables, and tools in detail.

01

ANALYSIS TYPE / 01

ISO 26262 / ARP 4754 / IEC 61508

standards compliance · lifecycle support

We provide end-to-end support for compliance with the three major functional safety standards — ISO 26262 for road vehicles, ARP 4754 for aerospace, and IEC 61508 for industrial systems. This includes process tailoring, work product creation, and independent assessment across the full development lifecycle.

Applicable Standards
ISO 26262ARP 4754AIEC 61508IEC 62278DO-178C
Tools Used
Ansys medini analyzeAnsys SCADE

Key Aspects

ASPECT / 01

Scope & Standard Selection

Determining which standard applies — and at what integrity level — based on the system type, operational context, and regulatory territory.

ASPECT / 02

Safety Lifecycle Planning

Defining the safety activities, roles, responsibilities, and schedule across all phases — from concept through decommissioning — as required by the applicable standard.

ASPECT / 03

Work Product Development

Creating the full set of required safety work products: safety plans, arguments, reports, checklists, and assessment packages aligned to the relevant standard clause structure.

ASPECT / 04

Independent Assessment

Providing third-party assessment to confirm that the safety case is complete, consistent, and meets the standard's requirements before submission or design release.

02

ANALYSIS TYPE / 02

Item Definition

system boundary · function allocation

Item definition establishes the system boundary, operational design domain, functions, and interfaces of the safety-relevant item. It is the foundational input for HARA and all subsequent safety planning — and must be complete before risk assessment can begin.

Applicable Standards
ISO 26262 Part 3IEC 61508 Part 2
Tools Used
Ansys medini analyzeEAST-ADLSysML

Key Aspects

ASPECT / 01

Boundary Definition

Establishing what is inside and outside the item — including hardware, software, sensors, actuators, and human interaction points.

ASPECT / 02

Function Identification

Listing all functions the item performs, including primary safety-relevant functions and secondary operational functions.

ASPECT / 03

Interface Documentation

Documenting all electrical, mechanical, and logical interfaces between the item and its environment, including assumed system-level constraints.

ASPECT / 04

Operational Design Domain

Defining the environmental conditions, operational modes, and use cases within which the item is required to function safely.

03

ANALYSIS TYPE / 03

HARA

hazard identification · risk rating · ASIL assignment

HARA (Hazard Analysis and Risk Assessment) systematically identifies hazardous events resulting from system malfunctions, assesses their severity and controllability, and assigns ASIL ratings — providing the safety goals that drive all downstream safety requirements.

Applicable Standards
ISO 26262 Part 3IEC 62278 RAM
Tools Used
Ansys medini analyze

Key Aspects

ASPECT / 01

Hazardous Situation Identification

Combining system functions with operational situations and failure modes to enumerate all credible hazardous situations that could arise from malfunctioning behaviour.

ASPECT / 02

Severity & Controllability Assessment

Assessing each hazardous situation against the severity of injury (S0–S3) and the ability of a driver or third party to control the situation (C0–C3).

ASPECT / 03

Exposure Analysis

Estimating the frequency and duration of exposure to each operational situation (E0–E4) — a key parameter in the ASIL classification.

ASPECT / 04

ASIL Assignment & Safety Goal Derivation

Combining S, E, and C ratings to determine the ASIL (QM, A, B, C, D) for each hazardous event and formulating the corresponding safety goals.

04

ANALYSIS TYPE / 04

Safety Goals & Requirements Modelling

top-level goals · functional requirements · technical allocation

Safety goals are decomposed into functional safety requirements and then into technical safety requirements, allocated to system elements and verified through model-based safety analysis — ensuring full traceability from hazard to design implementation.

Applicable Standards
ISO 26262 Part 4IEC 61508 Part 3
Tools Used
Ansys medini analyzeIBM DOORSSysML

Key Aspects

ASPECT / 01

Functional Safety Concept

Translating safety goals into functional safety requirements that describe the system-level behaviour needed to avoid or control each hazardous event, independent of implementation.

ASPECT / 02

Technical Safety Concept

Decomposing functional safety requirements into technical requirements allocated to hardware and software elements, with defined safety mechanisms for each.

ASPECT / 03

Requirements Traceability

Maintaining bidirectional traceability from safety goals through functional and technical requirements down to design elements and verification results.

ASPECT / 04

Model-Based Safety Analysis

Using SysML and MBSE tooling to formally model safety requirements, constraints, and allocations — enabling consistency checks and automated impact analysis across the safety case.

05

ANALYSIS TYPE / 05

FMEA & FMEDA

failure mode analysis · diagnostic coverage · SPFM/LFM

FMEA and FMEDA systematically identify hardware failure modes and evaluate diagnostic coverage, single-point fault metrics (SPFM), and latent fault metrics (LFM) — demonstrating compliance with the hardware architectural metrics required by ISO 26262 and IEC 61508.

Applicable Standards
ISO 26262 Part 5IEC 61508 Part 2AEC-Q100
Tools Used
Ansys medini analyzeIQ-FMEAReliaSoft XFMEA

Key Aspects

ASPECT / 01

Design FMEA (DFMEA)

Analysing each hardware element for potential failure modes, their effects on the system, and the severity of those effects — identifying design weaknesses before they manifest in physical testing.

ASPECT / 02

Diagnostic Coverage Evaluation

Assessing the effectiveness of on-board diagnostic mechanisms in detecting hardware faults — quantifying DC values for each safety mechanism against the relevant failure mode.

ASPECT / 03

Single-Point Fault Metric (SPFM)

Computing the fraction of random hardware failures that are covered by safety mechanisms or classified as residual — verifying compliance with ASIL-dependent SPFM thresholds.

ASPECT / 04

Latent Fault Metric (LFM)

Evaluating the fraction of latent faults detectable within the fault tolerance time interval — ensuring latent hardware faults are identified before they can combine with another fault to cause a hazardous event.

06

ANALYSIS TYPE / 06

Fault Tree Analysis

top-down · probabilistic · common cause

Fault Tree Analysis (FTA) provides a top-down, deductive approach to identify all combinations of hardware faults and software errors that could lead to a safety goal violation — quantifying the probability of the top-level hazardous event and identifying dominant cut sets.

Applicable Standards
ISO 26262 Part 10IEC 61025IEC 61508 Part 6
Tools Used
Ansys medini analyzeIsograph FaultTree+PTC Windchill Quality

Key Aspects

ASPECT / 01

Fault Tree Construction

Building the fault tree from the top-level safety goal violation downward — decomposing through logical gates to basic hardware failure events, software errors, and external faults.

ASPECT / 02

Probabilistic Assessment

Assigning failure rate data (from IEC 62380, MIL-HDBK-217, or field data) to basic events and computing the probability of the top event over the vehicle or system lifetime.

ASPECT / 03

Minimal Cut Set Analysis

Identifying the smallest combinations of basic events whose simultaneous occurrence causes the top-level failure — revealing the dominant failure paths and prioritising mitigation.

ASPECT / 04

Common Cause Failure Analysis

Evaluating β-factor and common cause contributions to determine whether independent failures could be triggered by a shared root cause — applying dependent failure analysis methods per IEC 61508.

07

ANALYSIS TYPE / 07

Safety Verification & Validation

V&V planning · evidence collection · confirmation reviews

Safety verification and validation confirms that the safety requirements have been correctly implemented and that the item achieves its safety goals in its operational context — providing the evidence base for safety case closure and product release.

Applicable Standards
ISO 26262 Part 4 & 8IEC 61508 Part 3DO-178C
Tools Used
Ansys SCADEIBM DOORSPTC Integrity

Key Aspects

ASPECT / 01

V&V Planning

Defining the verification and validation strategy, methods, environments, and acceptance criteria for each safety requirement — covering simulation, bench testing, HIL, and vehicle-level confirmation.

ASPECT / 02

Regression & Coverage Testing

Designing test cases with explicit traceability to safety requirements, executing them in representative environments, and tracking coverage against the agreed V&V plan.

ASPECT / 03

Confirmation Reviews

Conducting structured confirmation reviews of safety work products at phase boundaries to ensure completeness, consistency, and compliance with the applicable standard before development progresses.

ASPECT / 04

Safety Case Compilation

Assembling and packaging the complete safety case — combining the safety plan, HARA, safety concepts, analysis results, and V&V evidence into a coherent argument for product safety.

Start Your Functional Safety Programme

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