Mastering Functional Safety in Smart Systems: A Practical Guide to ISO 26262, IEC 61508 & Ansys Medini

In today’s rapidly evolving landscape of smart, connected, and safety-critical systems, a single software or hardware failure can risk lives, damage equipment, or cost millions. Ensuring functional safety, system reliability, and cybersecurity is no longer optional — it’s mission-critical.

Whether you're designing autonomous vehicles, aerospace control systems, or industrial automation platforms, the increasing complexity of modern systems demands more than spreadsheets and isolated tools. That’s where Ansys Medini Analyse comes in.

Using a model-based approach, Medini integrates safety, reliability, and security analysis into one unified platform — enabling teams to identify issues early, streamline FMEA, FTA, and FMEDA processes, and maintain alignment throughout the development lifecycle.

Compliant with industry standards such as ISO 26262, ARP4761/4754A, DO-178C, MIL-STD-882E, and ISO 21434, Medini empowers professionals across automotive, aerospace, and industrial sectors to develop safer and more robust systems — efficiently and confidently, with the expert support of Kaizenat Technologies.

 
<h4>Mastering Functional Safety Analysis Across Industries with Ansys Medini</h4>


Functional Safety supports the development of critical systems by furnishing a structured, norms-driven approach that ensures compliance and helps achieve the needed Safety Integrity Level (SIL). Safety analysis complements this by thoroughly identifying, assessing, and mitigating potential hazards throughout the entire lifecycle of modern, complex systems. Together, these approaches form the foundation for building safe, dependable, and authentic systems across safety-critical industries.

Ansys Medini Analyse is essential in this process, offering a unified, model-based platform for performing safety, reliability, and risk evaluations. The tool supports key industry-standard methodologies such as HARA, FHA, FMEA, FTA, HAZOP, and FMEDA/FMECA — all directly linked to system design, enabling engineers to efficiently conduct functional safety analysis.


<h4>A Model – Based workflow for Fucntional safety analysis</h4>

To successfully develop critical systems in compliance with industry norms, a unique model is used that blends a structured, V-shaped development process with continuous feedback loops for evaluation and improvement. This approach allows for ongoing learning and ensures adherence to safety norms. This model-centric safety workbench offers a comprehensive set of tools and analysis features essential for conducting functional safety evaluations.
 
<img src="https://api.kaizenat.com/uploads/blog-banner/model-based-workflow-functional-safety-analysis.png" width="100%"/>
 
V-Cycle approach emphasizes a lifecycle approach to safety, beginning with conception and definition phases and extending through design, implementation, verification, validation, operation, maintenance, and eventual decommissioning.



<h4>Ansys Medini Analyse for Safety, reliability and security Analysis</h4>

Ansys Medini Analyse is a unified, model-based tool specifically designed for conducting functional safety analysis of electronic systems. It facilitates safety and reliability evaluations for software-driven, safety-critical operations. The tool enables safety engineers to seamlessly analyse safety and reliability characteristics based on system engineering models. If these models are not already available, they can be created directly within the software, ensuring a smooth and efficient analysis process.

The rationale behind safety analysis styles is to provide a dedicated logical perspective that's directly linked to the system design. This ensures that safety analysis is not performed in isolation but remains tightly integrated with the design process.

 
<img src="https://api.kaizenat.com/uploads/blog-banner/ansys-medini-analyze-a-modal-based-and-integrated-solution.png" width="100%"/>
 

<h4>Key Concepts</h4>

• SysML Models used to depict boundary plates and highlight key system factors in SysML format.

• HARA/ FHA Functional Hazard Assessment (FHA) is a pivotal method for identifying potential failures in system functions and assessing the severity of their impact. This assessment is critical in deriving Safety Integrity Levels (SILs) — a measure of risk reduction needed for safety functions, primarily under standards like ISO 26262, ARP4761, etc.

• • HAZOP/ Guideword Analysis the Hazard and Operability Study is a systematic approach used to identify potential malfunctioning actions at both system and subsystem levels during the early phases of development.

• • FMEA Failure Modes and Effects Analysis helps identify possible failure causes, their resulting effects, and calculates the Risk Priority Number (RPN) to prioritise risks.

• • FMEDA Failure Modes, Effects, and Diagnostic Analysis is used to classify faults as safe or dangerous and to determine the Safe Failure Fraction (SFF) along with diagnostic coverage.

• • FTA/ RBD Fault Tree Fault Tree Analysis identifies minimum cut sets, calculates mean time criteria, and assesses failure probabilities. Reliability Block Diagram (RBD) modelling is used to estimate the reliability of individual subsystems as well as the complete system.

<h4>Model- based Reliability Analysis for Electronic/Electrical Systems in Ansys Medini Analyse </h4>

 
<img src="https://api.kaizenat.com/uploads/blog-banner/model-based-reliability-analysis-electronic-systems-ansys-medini-analyse.jpg" width="100%"/>
 

Reliability in electrical and electronic systems refers to the consistent performance of a system or component in carrying out its intended functions without failure over a defined period under standard operating conditions. It encompasses both functional lifetime and performance stability. Key criteria used to assess reliability include Mean Time Between Failures (MTBF), failure rate, and system availability. While achieving high reliability may involve higher initial costs, it significantly reduces maintenance requirements and operational downtime — making it essential for mission-critical and high-stakes operations.


<h4>Methods for Reliability Analysis</h4>

<h5>Failure Rate Prediction</h5>

Determine the failure rate (λ) and understand its significance in estimating the reliability of electrical/electronic (E/E) systems. Use the Bill of Materials (BOM) as input and extract failure rate data from standard reliability prediction texts such as SN29500, IEC 62380, MIL-HDBK-217F, 217Plus, NPRD, and EPRD. Once the base failure rate is obtained from these sources, adjust it using component-specific parameters from the BOM to derive the actual failure rate.
 
<img src="https://api.kaizenat.com/uploads/blog-banner/methods-reliability-analyse-failure-rate-prediction.png" width="100%"/>
 

<h5>Reliability Block Diagram</h5>

Introduce the Reliability Block Diagram (RBD) as a graphical method to represent system components and how they're connected. Use the system schematic as input to

build the RBD by representing individual components and linking them through series and parallel configurations. Apply the exponential distribution based on mission time to calculate overall system reliability.
 
<img src="https://api.kaizenat.com/uploads/blog-banner/reliability-block-diagram.png" width="100%"/>
 
<h5>Fault Tree Analysis</h5>

Fault Tree Analysis (FTA) is used to determine the causes of system-level failures by constructing logical diagrams showing the relationship between failures and their contributing components. The method identifies minimal cut sets, calculates the probability of the top event, and estimates metrics such as Mean Time to Failure (MTTF).
 
<img src="https://api.kaizenat.com/uploads/blog-banner/fault-tree-analysis.png" width="100%"/>
 

<h5>Failure Mode and Effect Analysis</h5>

Failure Mode and Effect Analysis (FMEA) is a systematic method for detecting possible failure modes in a system, analysing their root causes, and assessing their effects on overall system performance. This bottom-up method assesses each failure by evaluating its severity, probability of occurrence, and detectability, eventually calculating the Risk Priority Number (RPN) to prioritise risks. For RPN calculation, we will use SOD values from the FMEA standards (VDA-AIAG, SAE J1739, MIL-STD-1629).
 
<img src="https://api.kaizenat.com/uploads/blog-banner/failure-mode-effect-analysis.png" width="100%"/>
 
<img src="https://api.kaizenat.com/uploads/blog-banner/failure-mode-effect-analysis-new.png" width="100%"/>
 

<h5>Failure Mode and Effect Criticality Analysis</h5>


Failure Mode and Effect Criticality Analysis Failure Mode and Effect Criticality Analysis (FMECA) is an enhanced form of FMEA that incorporates criticality assessment to rank failure modes based on their impact on overall system performance. Like FMEA, FMECA follows a bottom-up approach. It builds upon design FMEA by introducing mission time and probability, and calculates the criticality value using severity, mission time, conditional probability, and failure rate.
 
<img src="https://api.kaizenat.com/uploads/blog-banner/failure-mode-effect-criticality-analysis.png" width="100%"/>
 

Using a model-based approach to assess the reliability of E/E systems in automotive and other safety-critical sectors offers a systematic and quantitative framework for analysing system performance and detecting potential failure modes while ensuring adherence to functional and safety regulations. By incorporating methods such as failure rate analysis, Reliability Block Diagrams (RBD), Fault Tree Analysis (FTA), FMEA,

and FMECA, manufacturers can effectively identify, manage, and reduce reliability risks throughout the system's lifecycle.



<h4>Ensuring Cybersecurity in Modern Vehicles: What Engineers Must Do</h4>

As vehicles become smarter and more connected, they increasingly rely on complex software, electronic control units (ECUs), and wireless communication. While these advancements enhance safety, performance, and user experience, they also introduce new vulnerabilities. Cyberattacks can compromise critical systems such as braking, steering, and infotainment, posing serious safety risks and privacy concerns. With the rise of autonomous and connected vehicles, ensuring robust cybersecurity is no longer optional — it is essential to protect passengers, maintain public trust, and comply with evolving regulatory standards.

<h4>Why Is Automotive Cybersecurity So Important?</h4>


Security vulnerabilities can allow hackers to deliberately cause system faults at any time of their choosing.
 
<img src="https://api.kaizenat.com/uploads/blog-banner/automotive-cybersecurity.png" width="100%"/>
 
With serious consequences at stake, who's responsible for guarding electronic systems against cyberattacks? That responsibility lies with automotive electronics engineering

teams. These teams are tasked with securely integrating a wide range of digital components, including:


• Navigation systems 

• Infotainment systems 

• Braking systems 

• Other critical vehicle functions 

Engineers must ensure that signals and controls are seamlessly coordinated — not just within each component, but across the entire electronic architecture. Their work is essential to optimise performance and ensure system-wide cybersecurity and functional safety.


<h4>Industry Standards Are Placing Additional Focus on Security</h4>


These standards force OEMs and electronic system providers to consider automotive cybersecurity as part of the product development process.

Cybersecurity standards are being established at the system level to ensure that automotive electronics engineers are effectively addressing security requirements.

ISO 21434, DO326, and DO356A ensure that engineers have arrived at a secure electronics architecture and have documented all their modelling and verification activities. These new standards are placing unprecedented pressures on electronics engineers in the automotive industry. Additionally, conventional workflows fall short of addressing these emerging requirements. What’s needed is a new modelling solution and an associated set of best practices designed specifically to meet the growing cybercrime challenge.


<h4>Mitigate Threats via a Smart Cybersecurity Strategy</h4>
The key to ensuring automotive cybersecurity is to thoroughly perform threat analysis and risk assessment across the entire electronics architecture. 
With this goal in mind, Ansys safety experts have developed a six-step, system-focused cybersecurity analysis approach to:
 • Quickly identify vulnerabilities and design flaws
 • Address them in an effort to mitigate any real-world hacking attempts
Ansys Medini Analyse supports engineers in ensuring the functional safety of automotive electronics and now includes enhanced features for validating system-level cybersecurity. This model-based, integrated tool assists in defining the analysis context, identifying assets and threats, creating attack trees, and conducting threat assessment and mitigation.
 
<img src="https://api.kaizenat.com/uploads/blog-banner/mitigate-threat-cyber-security.png" width="100%"/>
 
In conducting this analysis, engineers assess a wide range of attack scenarios and determine potential threats that might occur. These steps include:

 1. Identify the assets inside vehicle systems such as braking, steering, lighting, HVAC, GPS navigation, and infotainment systems.
2. Discover the system-level vulnerabilities. Find interfaces that place these assets and their performance at risk.
3. Understand the consequences. Determine what could happen when these vulnerabilities are exploited.
4. Estimate the probable likelihood of an attack by analysing the level of effort needed to carry it out.
5. Define a risk level for each threat. Calculate both the likelihood of an attack and the potential consequences.
6. Plan and execute appropriate cybersecurity measures. Guard against all identified threats, starting with those that have the highest risk levels.
Implementing this process early enhances the safety and security of in-vehicle systems while also giving companies a competitive advantage in the market.
<h4>Conclusion </h4>
The analysis conducted provided a structured and integrated approach to assessing system reliability, availability, maintainability, and safety. Integrating methods like FHA, FMEA, FMEDA, FTA, RBD, and HAZOP into a unified tool ensures consistent and traceable analysis across the entire system lifecycle. Medini’s support for industry standards like ISO 26262, IEC 61508, ARP4761/4754A, EN50126/EN50129 facilitated compliance and certification readiness. The model-based environment enabled early hazard identification and effective risk mitigation. Automated tools and integrated libraries simplified the quantitative assessment of failure rates and safety integrity levels. Overall, Medini enhanced the accuracy, efficiency, and completeness of the analysis process. Through advanced tools like Ansys Medini Analyse, system safety analysis in industries becomes more effective and compliant, helping engineers meet strict safety standards and deliver safer, more reliable systems.


<h4>Why This Blog Matters to Your Business</h4>
 • Up to 50% reduction in effort and time needed for safety and reliability analysis.
• Streamlined inspection readiness through version-controlled traceability and documentation.
• Unified safety platform that integrates seamlessly with PLM (Product Lifecycle Management) and MBSE (Model-Based Systems Engineering) tools.
• Early fault identification minimises design rework and helps accelerate time-to-market.

Why This Blog Matters to Your Business 
In today’s fast-evolving landscape of smart, connected products, ensuring safety, reliability, and cybersecurity is no longer optional — it’s a business imperative. These elements directly impact:
 • Customer trust and brand reputation 
 • Product quality and compliance with global standards 
 • Cost-effectiveness through reduced recalls, rework, and downtime 
• Strategic edge, especially in high-reliability industries like automotive, aerospace, and medical technology 
Neglecting any one of these areas can lead to system failures, safety incidents, cyber breaches, and costly legal or regulatory consequences. Businesses that prioritise them from the start gain a clear edge in innovation, efficiency, and customer loyalty.


<h4>Designed for Engineering and Compliance Decision Makers</h4>
If you're a: 
• Safety engineer 
• Product/Programme manager 
• Compliance or risk manager 
• Engineering Leader in Automotive, Aerospace, or Industrial sectors 
This blog gives you real-world solutions to Functional Safety challenges, backed by technology, standards, and support from an industry-proven partner. 
In all these cases, a software or hardware fault could lead to disastrous failure. Functional Safety is the only feasible path to mitigate such risks. 

<h4>Key Business Challenges </h4>
• Unpredictable certification timelines due to fragmented safety processes 
• High cost of late-stage safety issue discovery 
 • Misalignment among hardware, software, and system safety teams 
 • Disparate tools that hamper traceability and reuse
 • Difficulty aligning internal processes with ISO 26262, IEC 61508, and DO-178C


<h4>Artificial robotization – Smart Robotic Arm </h4>
Issue instrument under IEC 61508 was laid over because of deficient attestation. 
 result Medini automated the compliance workflow and enabled timely SIL- position assignment.



At Kaizenat Technologies Pvt. Ltd., an authorised Ansys Channel Partner, we specialise in enabling engineering teams like yours to accelerate time-to-market and de-risk product development through Ansys Medini. Whether you’re in Automotive, Aerospace, Industrial Automation, or Medical Devices, Functional Safety ensures operational durability and user safety.

Get a Free Demo and Expert Consultation on Functional Safety 
? Discover how your team can use Ansys Medini to eliminate guesswork and accelerate compliance. ? Click here to schedule a free personalised demo ? Call 08041500008 ? Email info@kaizenat.com 

Our expert advisers will walk you through: 
• How Medini fits into your existing workflow 
• Where you can cut compliance costs 
• How to fast-track your ISO/SIL certification process
Take Action – Empower Your Functional Safety Journey Today ✔️ Book your demo ✔️ Get a safety analysis checklist ✔️ Talk to a technical adviser
Functional Safety starts with informed decisions — let’s make yours count.

In today’s rapidly evolving landscape of smart, connected, and safety-critical systems, a single software or hardware failure can risk lives, damage equipment, or cost millions. Ensuring functional safety, system reliability, and cybersecurity is no longer optional — it’s mission-critical.
Whether you're designing autonomous vehicles, aerospace control systems, or industrial automation platforms, the increasing complexity of modern systems demands more than spreadsheets and isolated tools. That’s where Ansys Medini Analyse comes in.
Using a model-based approach, Medini integrates safety, reliability, and security analysis into one unified platform — enabling teams to identify issues early, streamline FMEA, FTA, and FMEDA processes, and maintain alignment throughout the development lifecycle.


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