Safety Engineering SERVICE / 06

Functional Safety Analysis
for E/E Systems

From hazard identification to ASIL compliance — end to end.

Functional safety analysis is a systematic approach used to identify, assess, and mitigate risks associated with the functional behaviour of safety-critical systems. Key aspects include hazard identification, risk assessment, and implementation of safety measures in accordance with ISO 26262, ARP 4754, and IEC 61508.

ISO 26262ARP 4754IEC 61508ASIL A–D

What We Deliver

Systematic Risk Identification,
Assessment & Mitigation

Our functional safety engineering team supports the complete safety lifecycle — from initial item definition and HARA through to FMEDA, FTA, and independent assessment. We work to applicable standards across automotive, aerospace, and industrial domains, delivering the analysis artefacts and traceability evidence required for certification and design release.

Whether you need a full safety case from the ground up or targeted support for a specific analysis type, our team integrates with your development process and tooling to deliver compliance-ready outputs on schedule.

10 Analysis Types
3 Major Standards Supported
ASIL D Maximum Integrity Level

Standards Coverage

ISO 26262 (Automotive)
ARP 4754A (Aerospace)
IEC 61508 (Industrial)
IEC 62278 (Rail)
DO-178C (Avionics)

10 Analysis Types

Our Functional Safety Capabilities

Select an analysis type to explore the methodology, key aspects, and applicable standards 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 analyzeDOORSPTC Windchill

Key Aspects

ASPECT / 01

Functional Safety Concept

Translating safety goals into functional safety requirements at the system level — defining what the system must do (and not do) to maintain safe state.

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

ASIL Decomposition

Splitting ASIL requirements between two independent channels to reduce the individual ASIL target for each — enabling more cost-effective hardware implementation.

ASPECT / 04

Requirements Traceability

Maintaining a complete, auditable trace from every safety goal through functional and technical requirements to design elements and verification results.

05

ANALYSIS TYPE / 05

Reliability for E/E Systems

failure rate · PMHF · quantitative targets

Reliability analysis quantifies the probability of hardware failure for electrical and electronic systems using failure rate databases such as IEC TR 62380, MIL-HDBK-217, and SN29500 — supporting PMHF and random hardware failure metric compliance under ISO 26262.

Applicable Standards
ISO 26262 Part 5IEC 61508 Part 2IEC TR 62380
Tools Used
Ansys medini analyzeRelexWindchill Prediction

Key Aspects

ASPECT / 01

Failure Rate Data Selection

Selecting appropriate failure rate data sources (IEC TR 62380, MIL-HDBK-217, SN29500, or manufacturer data) for each component in the design.

ASPECT / 02

PMHF Calculation

Computing the Probabilistic Metric for random Hardware Failures (PMHF) for ASIL B, C, and D functions to confirm compliance with the ISO 26262 quantitative targets.

ASPECT / 03

Safe Failure Fraction Analysis

Classifying all failure modes as safe or dangerous, detected or undetected, to calculate the SFF and verify that it meets the minimum threshold for the hardware safety integrity level.

ASPECT / 04

Mission Profile Sensitivity

Assessing how temperature, vibration, humidity, and operating hours affect the failure rate — and adjusting the PMHF calculation accordingly for the specific application environment.

06

ANALYSIS TYPE / 06

FMEA / FMECA

failure mode identification · effect analysis · criticality ranking

FMEA and FMECA identify potential failure modes of system elements, assess their effects on system function and safety, and prioritise corrective actions through RPN or criticality ranking — covering design FMEA, process FMEA, and system FMEA in accordance with relevant standards.

Applicable Standards
ISO 26262 Part 5ARP4761IEC 60812AIAG-VDA FMEA
Tools Used
Ansys medini analyzeXFMEA

Key Aspects

ASPECT / 01

Design FMEA (DFMEA)

Analysing each component's potential failure modes and their effects on the function, subsystem, and vehicle — identifying design changes that eliminate or mitigate risk.

ASPECT / 02

System FMEA (SFMEA)

Evaluating interactions between subsystems and identifying failure modes that only emerge at the system integration level — including interface failures and parameter mismatches.

ASPECT / 03

Criticality Analysis (FMECA)

Extending FMEA with quantitative criticality ranking — combining failure probability and severity to prioritise corrective actions in safety-critical systems.

ASPECT / 04

Process FMEA (PFMEA)

Analysing manufacturing and assembly process steps for failure modes that could introduce latent defects — essential for ASIL C/D hardware production compliance.

07

ANALYSIS TYPE / 07

FTA

top-down deductive · failure logic · probability of violation

Fault Tree Analysis (FTA) models the logical combination of hardware failures, software faults, and external events that could lead to a system-level hazardous event — providing a structured basis for quantitative probability of failure calculations and safety argument support.

Applicable Standards
ISO 26262 Part 5IEC 61025ARP4761IEC 61508
Tools Used
Ansys medini analyzeIsograph FaultTree+OpenFTA

Key Aspects

ASPECT / 01

Fault Tree Construction

Building a top-down logic model from the top-level hazardous event through AND/OR gates to the root failure causes at component or function level.

ASPECT / 02

Minimal Cut Set Analysis

Identifying all minimal combinations of basic events that are sufficient to cause the top event — revealing single-point failures and critical dependency paths.

ASPECT / 03

Quantitative Probability Calculation

Computing the probability of the top event from component failure rates and the Boolean logic of the fault tree — verifying compliance with ASIL-level targets.

ASPECT / 04

Importance Measures

Calculating Birnbaum, Fussell-Vesely, and Criticality importance measures to rank basic events by their contribution to system-level failure probability.

08

ANALYSIS TYPE / 08

FMEDA

diagnostic coverage · SPFM · LFM · PMHF verification

FMEDA extends FMEA with quantitative failure rate data and diagnostic coverage analysis to verify that the safety mechanism architecture achieves the required SPFM, LFM, and PMHF targets specified by ISO 26262 for each hardware element.

Applicable Standards
ISO 26262 Part 5IEC 61508 Part 2
Tools Used
Ansys medini analyzeItem Toolkit

Key Aspects

ASPECT / 01

Failure Mode Classification

Classifying each failure mode as safe or dangerous, and as detected or undetected by the safety mechanism — the foundation for all subsequent metric calculations.

ASPECT / 02

Diagnostic Coverage Calculation

Computing the DC for each safety mechanism by comparing its ability to detect dangerous failure modes against the total dangerous failure rate of the monitored element.

ASPECT / 03

SPFM & LFM Metric Verification

Calculating the Safe Failure Fraction and Latent Fault Metric for each hardware element and verifying compliance with the minimum thresholds required for ASIL B, C, and D.

ASPECT / 04

PMHF Contribution

Accumulating the residual risk contribution of each undetected dangerous failure mode to the system-level PMHF — confirming the overall target is met.

09

ANALYSIS TYPE / 09

RBD

system reliability · availability · redundancy architecture

Reliability Block Diagram (RBD) analysis models the logical dependencies between system components to evaluate overall system reliability, availability, and safety integrity — particularly useful for redundant, parallel, and standby system architectures.

Applicable Standards
IEC 61508 Part 2ISO 26262 Part 5IEC 61079
Tools Used
Ansys medini analyzeBlockSimIsograph Reliability Workbench

Key Aspects

ASPECT / 01

Series, Parallel & Standby Configurations

Modelling component interdependencies in series (all must work), parallel (any can work), and standby (backup activates on failure) configurations to compute system-level metrics.

ASPECT / 02

System Reliability Calculation

Computing the probability that the system performs its required function over the specified mission time — accounting for component failure rates and repair times.

ASPECT / 03

Availability Analysis

Calculating steady-state and time-dependent system availability — critical for safety systems with maintenance intervals and proof-test requirements.

ASPECT / 04

Architecture Comparison

Comparing alternative redundancy architectures (1oo2, 2oo3, hot standby) against reliability and cost targets to select the optimal safety architecture.

10

ANALYSIS TYPE / 10

DFA

common cause · common mode · independent channel verification

Dependent Failure Analysis (DFA) identifies common cause failures (CCF) and common mode failures (CMF) that could simultaneously affect independent or redundant channels — a mandatory activity for ASIL C and ASIL D systems under ISO 26262.

Applicable Standards
ISO 26262 Part 5 & 9IEC 61508 Part 2ARP4761
Tools Used
Ansys medini analyze

Key Aspects

ASPECT / 01

Common Cause Failure Identification

Identifying shared resources — power supplies, ground planes, temperature environments, software platforms — that could cause concurrent failure in supposedly independent channels.

ASPECT / 02

Common Mode Failure Analysis

Evaluating design similarities between redundant channels that could produce identical failure responses to the same input stimulus — defeating diversity.

ASPECT / 03

Independence Verification

Verifying that spatial, thermal, electrical, and software separation between redundant channels is sufficient to prevent correlation of failures.

ASPECT / 04

Corrective Measure Definition

Specifying design changes — diversity, isolation, physical separation, or monitoring — to reduce CCF and CMF contributions to an acceptable level.

Start Your Functional Safety Engagement

Connect with our safety engineering team to define the right analysis approach, timeline, and tooling for your project.

Contact Us Today