A Closer Look at the Most Common Gaps found in Functional Safety Assessments

September 16, 2024 – Reading time: 7 minutes

Comprehensive assessments throughout the entire safety lifecycle of products are required by most of the relevant functional safety standards in each industry. These assessments ensure that products comply with relevant safety standards and regulations, such as ISO 26262 for automotive systems, which is essential for both legal and market acceptance.

One of the primary reasons assessments often fail is due to a weak safety culture within the organization. Safety managers are not sufficiently involved in the hands-on development process and are often not aligned with the project team, which leads to a disconnection between safety specifications and actual product development. Without a robust safety culture, it becomes challenging to prioritize and integrate safety into every aspect of the development process.

Let’s imagine a tier 1 supplier with a poor safety culture, in which insufficient safety assessments are planned in due course. The customer deadline is looming, but development activities are lagging far behind, the product release is in jeopardy and presenting the status to management and the customer will be a big challenge. The question to ask in the first step is primarily not how to reach this specific deadline, but rather how not to find ourselves in the same situation again. For instance, in the case of ISO 26262, a conditionally accepted assessment is then often determined when an assessment is only partially fulfilled.  For this, an action plan must be included in the release note, with a defined end date and a limited number of units to be produced, which will pose new challenges. The supplied parts will then have certain requirements, e.g. that they may not be installed in series vehicles because they have not passed the assessment. The approach towards establishing a strong safety culture determines to what extent such challenges can be prevented.

A reliable and effective safety management is the cornerstone of safe product development. Establishing a comprehensive safety plan is challenging, especially without a clear, development-aligned process. Additionally, issues in the classification of tools, particularly in establishing confidence in software tools, can further complicate safety management. These challenges create uncertainty and hinder the ability to manage safety effectively throughout the project lifecycle.

Additionally, there is often a lack of understanding regarding the importance of the safety case (SC), which is crucial to show compliance with the respective standard. To address these issues, it is essential to ensure that safety management practices are well-defined and consistently applied. Clear guidelines and procedures should be established as well for the classification and use of tools, with a particular focus on software tools, to build confidence and reliability.

Let’s take a closer look at some safety management related gaps and how to prevent them: documentation management, absent or incomplete work products, and insufficient test results. One of the most common gaps is a lack of documentation, either on missed versioning, work product description, review reports, the naming of authors or dates, or incorrect referencing. In that case, a confirmation review should also consider requirements regarding documentation management, and for all critical safety work products, this confirmation review report must be available. An assessment may uncover that not all work products are available as requested per ISO 26262. A root cause might be that there was simply no capacity for the development team to create or finalize the missing work products. Thus, an increase in capacity could resolve the issue. In the case of failed tests, a root cause analysis becomes necessary. Depending on the results, the solution may be different. This can be the repetition of the tests, modification of test setup, design change or an argumentation, to why the failed test is not safety critical.

At the engineering level, technical challenges can significantly impact the success of safety assessments. Errors in the implementation of Failure Mode and Effects Analysis (FMEA) according to the standard are common. These errors can lead to incomplete or inaccurate identification of potential failure modes, which undermines the overall safety of the product. Additionally, the use of parts and components that are not designed or developed following relevant standards can introduce unforeseen risks.

Some of the other most common gaps encountered at the engineering level are failed test cases and missing various work products for instance from Part 7 of ISO 26262 including safety case, process capability report, process control plan and flow chart. Addressing these engineering challenges requires a thorough understanding of safety standards and meticulous attention to detail in the design and development process.

To ensure a more comprehensive and successful safety assessment process and reach the product release smoothly, we at INVENSITY recommend considering the following points and acting upon them, to prevent and be able to address the assessment gaps effectively:

• Adherence to standards: Ensure a good understanding of the safety standards, their requirements and strict adherence to normative specifications for carrying out assessments as outlined in various safety standards.
• Early and continuous assessments: Start assessments early and conduct them at each stage of the product lifecycle to identify and address gaps as soon as possible.
• Transparency and communication: Regularly present the current development status to management and customers to maintain transparency and build trust
• Resource allocation: Apply pressure on the development department to secure more resources, which can accelerate progress and address issues more effectively.
• Focus on actual problems: By identifying gaps early and focusing on actual problems, the team can address issues promptly, thereby minimizing the risk of a delayed product launch.

If you require a Functional Safety Assessment or need support in preparing for an audit, please contact us for a non-binding consultation.

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