Tag Archive for: Requirements & Requirements Management Page 4
Tag Archive for: Requirements & Requirements Management
Jama Connect Features in Five: Release Management via Reuse & Synchronization
Learn how you can supercharge your systems development process! In this blog series, we’re pulling back the curtains to give you a look at a few of Jama Connect’s powerful features… in under five minutes.
In this Features in Five video, Máté Hársing, Solutions Manager at Jama Software, demonstrates how Jama Connect helps teams streamline release management with its reuse and synchronization capabilities.
VIDEO TRANSCRIPT
Máté Hársing: Hello and welcome. My name is Máté Hársing, and I’m a Solutions Architect at Jama Software. In this video, we’re going to explore how Jama Connect helps teams streamline release management with its reuse and synchronization capabilities. Managing multiple product releases often introduces challenges such as tracking changes across different product versions, ensuring teams work on release branches without disrupting the main project, merging updates without losing critical information or creating inconsistencies, maintaining traceability and compliance in industries with strict regulatory requirements.
Without the right tools, these challenges can lead to delays, increased costs, and risks of errors. Jama Connect addresses these challenges with its reuse and synchronization capabilities.
By allowing you to duplicate projects or components, Jama Connect creates a release branch where teams can work independently. The platform provides powerful comparison tools at the item, set, and project levels, enabling you to see changes clearly.
When it’s time to merge updates, Jama Connect gives you full control, allowing you to select specific changes while maintaining traceability and alignment. Now let’s see this in action. I’ll start by showing the main branch of the project and how it’s in sync with a specific release branch, release 2.0. This release branch is a separate project that will include updates and modifications specific to this version once we start working on it. As you can see, so far, the synchronization is fully intact between these two projects.
Hársing: Now let’s take a look at the synced items widget starting at the item level. This widget shows the relationship between this specific operational time requirement in the main project and the release branch. You can see they are currently in sync, meaning there is no difference between them. If I change the operational time for release two zero to a higher number, as we want to ensure higher user satisfaction, you’ll see they are now out of sync.
By clicking on the button, we can see the red line differentiation between the main branch requirement and the release-specific requirement for release 2.0. Moving up to the set level, we can view how entire groups of requirements are synced. This provides a broader perspective, allowing teams to manage changes across multiple related items efficiently. Let’s add a new requirement to release 2.0 and delete an existing one so that you can see how the information will show up when comparing the two sets between the main branch and release 2.0.
Finally, at the project level, you can see an overview of synchronization across the entire project. This is particularly useful for tracking overall progress and ensuring alignment between the main branch and the release.
Now I’ll demonstrate how to merge changes back into the main project. Jama Connect allows you to make different kinds of merges. For instance, you can accept specific changes, reject others, or use the consolidation option to manage conflicting requirement descriptions side by side. This ensures the two versions of a requirement can be refined into a common denominator, maintaining clarity and consistency.
Hársing: I’d like to emphasize that both reusing and synchronizing are permission-controlled so that only appointed team members can execute these tasks. Each dedicated project can also be baselined creating a snapshot in time. This is invaluable for generating submission-ready documentation, especially in regulated industries such as medical device design and development. Additionally, any change made in either project, the main branch or the release branch, propagates reactive change management capabilities via the Suspect Link tool. This feature automatically flags impacted items, ensuring teams can quickly assess and address the downstream effects of any modification.
These features reduce risks, improve collaboration, and ensure compliance by keeping everything organized and transparent. Jama Connect simplifies release management so you can focus on delivering high-quality products.
Thank you for watching this demonstration of release management via reuse and synchronization in Jama Connect. If you would like to learn more about how Jama Connect can optimize your product development process, please visit our website at jamasoftware.com. If you are already a Jama Connect customer and would like more information about release management via reuse and synchronization, please contact your Customer Success Manager or Jama Software Consultant.
https://www.jamasoftware.com/media/2025/02/FIF-Release-Mangement-2.jpg10801920Máté Hársing/media/jama-logo-primary.svgMáté Hársing2025-02-07 03:00:242025-02-07 09:23:04Jama Connect® Features in Five: Release Management via Reuse & Synchronization
Transform Engineering Processes: Bridge Gaps Between Teams and Tools Effectively
Engineering organizations face challenges delivering complex products on time, within budget, and with high quality. Teams often work with different tools, creating data silos that slow the digital engineering process. These gaps lead to missed requirements, delays, and defects.
In this webinar, our Jama Software experts Preston Mitchell, Vice President of Solutions & Support; Mario Maldari, Director of Product & Solution Marketing; and Vincent Balgos, Director of Solutions & Consulting, discuss how Jama Connect®, and our Jama Connect Interchange™ add-on, address these challenges through key use cases.
What you’ll learn:
Traceable Agile: Integrate systems engineering and software teams using Jama Connect + Jira to drive quality and speed.
Scalable FMEA Process: Empower reliability and risk management teams with Jama Connect + Excel for efficient FMEA analysis.
Universal ReqIF Exchange: Seamlessly import, export, and round-trip ReqIF exchanges across requirements tools with Universal ReqIF, enabling teams to co-develop requirements with stakeholders and partners.
The video above is a preview of this webinar – Click HERE to watch it in its entirety!
VIDEO TRANSCRIPT
Preston Mitchell: We are here to talk about how to save precious engineering time, and each of us is going to cover a specific use case that we think will help your teams save a lot of time, utilizing both Jama Connect, as well as Jama Connect Interchange. And when you think about where is most of the time wasted in engineering teams, we typically find it’s something that visually looks like this. It’s siloed teams and tools across the system engineering V model, and we really find that these things are the number one cause of negative product outcomes.
You know them, you’re probably intimately familiar with them. It’s a lack of identification of defects, missed requirements, or lack of coordination. A lot of manual steps to connect things, maybe requirements that live in one tool, and your system testing that lives in a different tool. And a lot of this can be highly manual, which is really a tough thing when you have to satisfy some of the industry regulations that a lot of our customers work with.
As we all know, kind of late detection of issues really leads to a huge cost in order to correct that with a project. You can kind of see in this bar graph here, that I’ve got on the left the different phases, going to the right of a typical product development. So you’re starting in the requirements definition and design, and moving all the way to acceptance testing. Typically, the number of faults or problems are introduced very early in the requirements definition and design phase. But the problem is they aren’t found until later in the project, like during integration or system testing. And even if you get to the acceptance testing level, you can see the exponential increase in cost to fix these expensive errors. These is not Jama Connect’s numbers, these numbers are from sources at The International Council on Systems Engineering (INCOSE) and National Institute of Standards and Technology (NIST). So you can really take away from this is the fewer errors that we introduce early, or the faster or sooner that we identify those issues, the better off we’re going to be and the more engineering time we are going to save.
How do we do this? Well, Jama Software, we are the number one requirements management and Live Traceability™ product in the market. We really bring a lot of resources and technology to bear to help you manage your product development, whether that’s complex and highly scaled types of products. We help you bring all the collaboration and reviews online. And we help you, number one, integrate the different state of the product across the many disparate tools that you might have in your engineering departments, and, specifically, that’s going to allow you to then measure and improve your traceability.
Mitchell: We work with a lot of the key industries that you see here at the bottom, and in particular, like Vincent, you work with the medical devices. I think your use case that you’re going to cover is going to be very built off of that medical device industry. But really, a lot of the use cases we’re going to cover today are applicable to all of these industries.
We are the leader, and we’d like to be bold about it. We are number one according to G2 in terms of requirements management and traceability tools. So we encourage you to check out the different ratings and how we stack up against our competitors.
The ultimate goal that we want to get you to is saving that time. So moving from disparate, siloed teams and tools to an actual integrated system of Live Traceability. We actually have benchmark data from all of our cloud customers, where we can actually show a correlation between the customers that have a greater traceability score, meaning all the expected relationships have been built out. We find that they have 1.8x faster time to defect detection, nearly 2.5x times lower test case failure rates, and then typically a 3.5x higher verification coverage. So it behooves you and your engineering teams to think about how can we actually integrate, and save ourselves time, and that’s just going to create a higher-quality product down the line.
I’d be curious to pause right here. We have a poll. I’d be interested in asking, if you take a step back and think about your R&D teams, all the different tools and teams that you have, what percentage would you say today in your organization is actually fully covered by Live Traceability? 100%, 50%, 0%? I’d be kind of interested in the scale on that. So we should see a poll pop up here, and I’ll give you a couple of seconds to answer that.
Now, we see some answers coming in. Thank you. Yeah, as to be expected, it’s not anywhere near 100%. Most of the companies that we work with are struggling with this, and so this is where we really want to help them out. And how do we do that? Well, our Jama Connect Interchange add-on to Jama Connect is a really powerful tool that we’re going to walk you through today, and it’s going to allow you to automate the connection between your data and process.
So we’re going to cover three use cases. I’m going to talk briefly first about Traceable Agile™, and this is how we integrate systems and software teams, using Jama Connect and a very popular tool that a lot of our software organizations use, which is Atlassian Jira. So we’ll talk about that Traceable Agile use case. Then Vincent is going to cover the Scalable FMEA Process, so how to utilize the power of the functions that are in Excel, and bringing those functions to bear inside of Jama Connect, so that you can do risk management and reliability management, but tied in with your requirements and testing. And then, finally, we’ll end on Mario covering Universal ReqIF Exchange, and this really enables you to co-develop with partners and suppliers across Jama Connect, but also maybe even different requirements management tools. So let’s dive in.
Mitchell: So when you think about Traceable Agile, Agile software, it’s a methodology, as well as a philosophy. It’s been around software teams for a long time, and it works well. It’s been widely adopted, and widely successful. At the same time, a lot of complex products are not made up of solely software. They have to actually be integrated in with the hardware and perhaps other mechanical aspects of these products that you’re building. So there’s a balance, right? There’s a balance of being completely Agile, but also making sure that you follow some process.
And kind of where we find that Agile sometimes can break down when we talk with software engineering leaders. They have these very common questions that they bring up, and it’s what keeps them up at night. How do I know which requirements have been missed? Am I actually covering everything? How do I know that I’m actually testing all of my requirements, and which ones of those have failed? The fourth bullet there, how do I identify rogue developments? It’s like, how do I make sure my teams are not gold-plating the product, and we’re actually meeting the stakeholder or the user needs that we’re trying to deliver to? And then, finally, change. Change is a given in this fast-paced environment, so how do I know when impacts are made? When changes are made in the software or in the hardware, how do I know what those impacts are across?
So the solution to this is Traceable Agile. It’s really no change to how your software teams may work today using Atlassian Jira. Really, what we are adding on is the ability to auto-detect gaps and measure and take action on those. And so I’m going to step into Jama Connect to give you a little bit of a demonstration here.
Use Cases and Strategies for Simplifying Variant Management
Variant management enables organizations to efficiently tailor requirements for diverse markets while maintaining alignment across teams.
Jama Connect® offers flexible strategies to simplify creation, adaptation, and tracking of multiple variants. These approaches facilitate efficient reuse, reduce complexity, and maintain traceability across complicated product lines.
Identifying and adapting product variants based on evolving market dynamics, regulatory requirements, and unique customer needs to ensure consistent compliance.
Streamlining variant creation by configuring specific versions of product components, optimizing reuse, and fostering alignment across complex product lines.
Leveraging a structured feature model to effectively manage options and better understand complex product variations.
Below is an abbreviated transcript and a recording of our webinar.
The video above is a preview of this webinar – Click HERE to watch it in its entirety!
VIDEO TRANSCRIPT
Matt Mickle: We have a fun topic today, walking through variant management use cases with the goal of simplifying this sometimes complicated topic. I will start off by walking through some of the common use cases that we often hear, followed by some concrete examples of how we would see these within the industry. I’ll talk a little bit about how we’ll solve these within Jama Connect and then have some demonstration of this directly in the tool. I’ll do this for each use case as we proceed, and then we’ll move on to some Q&A and I’ll answer some of your questions.
So, what do I mean when I say variant management? Well, simply, I would describe variant management as any process or technique that is used to manage variability and assets within a project. This could be in the form of certain techniques, such as feature-based product line engineering, which we’ll talk a little bit more about later. Configuration management, product derivation, or branch and merge. A product can vary in many ways, such as different features, material or components, premium services, or levels of performance. Here are some examples you might recognize. Models of home appliances with different sizes or capabilities, like these refrigerators. Microcontrollers with a configuration of reusable IP blocks. Medical devices, such as insulin pumps or digital thermometers having an array of features based on setting, method of application or type of consumer. As well as everyday devices, such as smartphones or smartwatches with different uses or consumer profiles.
Nearly every product you could think of has some amount of variation. And the process of managing those variants extends from the conception of the products, all the way into their description at the point of sale, and maintenance thereafter. So, one of these methods, which we will mention in the discussion today, is product line engineering, or PLE for short. And for this, we’ll use the simple definition, a focus on engineering for a family of products with similar features, components or modules as a single product line to leverage commonality and variability, minimize the duplication of effort, and maximize reusability.
Mickle: Now, a couple of definitions that go along with that from the standards for product line engineering, from ISO 26550, the definition of a feature would be an abstract functional characteristic of a system of interest that end users and other stakeholders can understand. And from the product line engineering for feature-based product line engineering standard, ISO 26580, a product line would be a family of similar products with variations in features. So, product line engineering could be considered as the next step in maturity. Single system engineering. And as the ISO standard on software and system engineering for product line engineering and management states, product companies utilizing single system engineering and management approaches may end up with highly complex and low-quality products. Low productivity, high employee turnover, and less than expected customer satisfaction.
So, let’s instead talk about the benefits of moving from single-system engineering into product-line engineering. Product line engineering enables organizations to create product line architecture that allows for the systematic reuse of components, modules, and assets across different products within a product line. This promotes efficiency by reducing redundancy in the need to recreate similar functionalities for each product. By reusing existing components and assets, organizations can significantly reduce development costs. Product line engineering allows for economies of scale, as the investment in creating a core set of assets can be spread across multiple products, leading to cost savings in the long run.
With product line engineering, organizations can streamline the development process by leveraging existing components and architectures. Faster time to market for new products, since development efforts are focused on creating unique features, rather than rebuilding common functionalities. Product line engineering helps ensure consistency in products across the product line. By reusing well-tested and validated components, the likelihood of introducing defects or inconsistencies is reduced. And this will lead to higher overall product quality. As market demands change or new technologies emerge, product line engineering provides a framework that allows organizations to adapt and evolve their product line more easily. This enables the addition of new features or modification of existing ones without starting the development from scratch.
Mickle: Product line engineering supports efficient configuration management, allowing organizations to define and manage variations and products through configuration, rather than by creating separated versions or desynchronized copies of content. This simplifies the task of handling different customer requirements or market-specific adaptations. Product line engineering makes maintenance and upgrades more manageable. Changes or bug fixes can be applied to common components, and then the updates can be propagated to all of the products within the line, ensuring that each product benefits from the improvements without having to undergo individual modifications.
And finally, product line engineering helps mitigate the risks associated with product development by relying on well-established and proven components. Since these components have been used and tested across multiple products, the likelihood of critical issues arising is reduced. Now, of course, there are many benefits for product line engineering, but there are a lot of challenges that a company goes through in order to try and move towards product line engineering. For example, let’s say a company starts out with a single product and then begins to build variants on that product, turning it into a product line. As the number of variants and variation between them grows, the ability to manage them becomes more and more challenging.
When a change is made, it’s important to assess not only the impact of that change within the product, where the change is made, but also in any products that are part of the same product line. If the change is against common requirements, then the decision is needed on whether they need variation. New versions or configurations of components of a system will need to be thoroughly reviewed with regards to how they interconnect. This becomes even more challenging and complex when considered as the product development data moves from one development application to the next. Throughout the supply chain, information about progress and change needs to flow and be collected in order to see overall status.
https://www.jamasoftware.com/media/2025/01/Webinar-Recap-Use-Cases-and-Strategies-for-Simplifying-Variant-Management-.png9001600Matt Mickle/media/jama-logo-primary.svgMatt Mickle2025-01-28 03:00:052025-03-19 07:37:37[Webinar Recap] Use Cases and Strategies for Simplifying Variant Management
Jama Connect® Stands Alone as the Leader in Requirements Management Software
This recognition is particularly meaningful because G2’s rankings are based on verified user reviews and insights from real customers, analyzed through their proprietary v3.0 algorithm. The Winter 2025 Grid Report reflects data collected through November 19, 2024, highlighting the best-performing tools in the field.
But that’s not all — Jama Connect received multiple accolades across all business sizes and regions, including:
Overall Leader
Momentum Leader
Small-Business Leader
Mid-Market Leader
Enterprise Leader
EMEA Leader
Europe Leader
Learn more about the Winter 2025 G2 Grid for top Requirements Management Software products: DOWNLOAD IT HERE
Why This Recognition Matters
This accomplishment underscores our commitment to helping customers transition from document-based processes to a modern requirements management platform. Jama Connect empowers teams to manage complex product, systems, and software development with unmatched clarity and collaboration.
We owe this success to the incredible feedback from our users. Here’s what they’re saying:
“Jama Connect is not only a ‘document oriented’ ALM tool, it gives the organization the ability to map the project structure to the product structure, making it an easy entry point for R&D folks. Configured properly, it is a real technical and regulatory ‘single source of truth.” — Frederic Fiquet, Director, Systems Engineering, G2.com
“Product Design teams need a requirements management tool like Jama Connect. Using Jama Connect allows our software development team to have a well-organized and well-written set of requirements. It allows us to more easily maintain a baseline of features in our continuously evolving software.” — Mark M., Mid-Market, G2.com
We are committed to providing the best possible experience for our users, and being named the overall leader by G2 is a testament to the success and satisfaction our customers have found with Jama Connect.
From all of us at Jama Software, thank you!
https://www.jamasoftware.com/media/2025/01/2025-01-21_g2-leader-Winter2025.png5121024Jama Software/media/jama-logo-primary.svgJama Software2025-01-21 03:00:142025-01-16 17:47:56Jama Connect® Stands Alone as the Leader in Requirements Management Software
2025 Expert Predictions for the AEC Industry: How Technology, Emerging Trends, and Innovation Will Shape the Industry in 2025 and Beyond
As we look toward the next five years in the Architecture, Engineering, and Construction (AEC) industry, emerging technologies are set to revolutionize how buildings are designed, constructed, and maintained. From the rise of digital twins to the growing integration of AI and machine learning, the tools and strategies transforming the industry promise to boost efficiency, sustainability, and collaboration. As companies prepare for these advancements, understanding how these technologies will shape the landscape and adopting the right tools will be critical.
In part five of our annual predictions series, Joe Gould, Senior Account Executive at Jama Software, shares his insights on the trends, challenges, and innovations shaping the future of AEC.
Question 1: What emerging technologies or digital tools do you believe will most significantly reshape the AEC industry in the next five years, and how can companies prepare to integrate these advancements effectively?
Joe Gould:
Digital Twins – The use of digital twins to create real-time, virtual representations of physical assets is set to revolutionize operations and maintenance. This technology provides actionable insights, predictive maintenance, and enhanced asset performance management. Implement IoT sensors and connect data streams to develop digital twin capabilities. Start with pilot projects to showcase value and gradually expand their use.
AI and Machine Learning – AI-driven tools will enhance project planning, risk management, and resource optimization. Machine learning models can analyze historical data to predict delays, optimize schedules, and reduce costs. Integrate AI into existing workflows, such as predictive analytics for scheduling or automated quality control checks, to reduce manual errors and inefficiencies.
Modular and Prefabrication Technologies – Offsite construction and prefabrication are becoming more efficient with advancements in design automation and digital manufacturing tools. Adopt software platforms that integrate modular construction workflows with design and scheduling tools. Establish partnerships with prefabrication facilities.
Sustainability Focused Tools – These are tools for energy modeling, lifecycle analysis, and carbon tracking will drive environmentally responsible design and construction. Embed sustainability metrics into project KPIs and adopt tools that facilitate compliance with green building certifications like LEED or BREEAM.
Question 2: As sustainability goals become increasingly prioritized, what role do you see software and product development playing in achieving more environmentally friendly and energy-efficient designs within the AEC sector?
Gould: Software and product development play a pivotal role in advancing sustainability and energy efficiency within the AEC sector by enabling more data-driven, holistic, and collaborative approaches to design and construction. Tools such as Building Information Modeling (BIM), energy simulation software, and lifecycle assessment platforms allow architects and engineers to optimize designs for energy performance, material efficiency, and reduced carbon footprints from the earliest project stages. Digital twins extend this capability by facilitating real-time monitoring and optimization of building performance throughout its lifecycle, ensuring long-term energy efficiency and reduced environmental impact. By leveraging these technologies, companies can not only meet regulatory demands but also position themselves as leaders in creating environmentally responsible and energy-efficient designs that contribute to a sustainable future.
Question 3: With remote and hybrid work now a permanent reality for many industries, how do you anticipate these work models impacting collaboration and innovation in the AEC space, especially regarding software and project management tools?
Gould: With remote and hybrid work becoming the norm, the AEC industry is seeing some interesting shifts in how teams collaborate and innovate. While it used to be all about in-person meetings and site visits, now software and project management tools are stepping up to bridge the gap. Cloud-based platforms make it easier than ever for teams to share updates, track progress, and stay connected no matter where they’re working from. This new way of working is also pushing companies to adopt more streamlined workflows and better communication practices, which can actually spark innovation!
Question 4: How do you foresee AI and machine learning influencing decision-making and risk management in AEC projects? What are some challenges or limitations the industry might face in adopting these technologies?
Gould: AI and machine learning are definitely shaking things up in the AEC industry, especially when it comes to decision-making and risk management! These technologies can analyze massive amounts of data — like project schedules, historical performance, and even weather patterns — to predict potential delays, budget overruns, or safety risks before they happen. It’s like having an early warning system that helps teams make smarter, faster decisions. On top of that, AI can optimize workflows, improve resource allocation, and even suggest more efficient designs.
Question 5: As a follow up question: Do you have any concerns or anticipate any negative impacts as it pertains to AI & ML.
Gould: I believe there are some challenges to getting these tools up and running. One big hurdle is the quality of data — if your data isn’t clean or consistent, the AI’s predictions won’t be reliable. There’s also a learning curve; not everyone in the industry is ready to fully embrace these new tools, so training and change management are crucial. Plus, while AI is great for identifying trends, it still relies on human expertise for context and final decisions. So, while the potential is huge, there’s still some work to do in terms of adoption and integration in my opinion.
Question 6: Given the current emphasis on data-driven project management and predictive analytics, what strategies would you recommend for AEC firms to better leverage data for optimizing project outcomes and resource allocation?
Gould: If AEC firms want to get more out of data-driven project management, it starts with organizing their data. Centralizing everything — budgets, schedules, progress updates —into tools like BIM or Procore makes it easier to analyze and act on insights. Predictive analytics can then help spot issues early, like delays or resource shortages, so teams can adjust before problems escalate. The key is to train people to use the data effectively and start with small pilot projects to build confidence. When everyone’s on the same page and using the same data, decisions get smarter, and projects run smoother.
Question 7: Are there any additional insights you have regarding predictions, events, or trends you anticipate happening in 2025 and beyond?
Gould: Looking ahead to 2025 and beyond, I think we’ll see a bigger push for sustainability in AEC, with more focus on net-zero buildings and carbon tracking tools. AI and automation will likely play an even larger role in design and project management, making workflows faster and more efficient. Plus, digital twins and smart buildings will continue to grow, especially as IoT tech gets better. The challenge will be adapting quickly while balancing innovation with practicality, but the opportunities for transformation are huge!
https://www.jamasoftware.com/media/2025/01/2025-01-16-AEC.png5121024Joe Gould/media/jama-logo-primary.svgJoe Gould2025-01-16 03:00:532025-01-16 09:00:372025 Expert Predictions for the AEC Industry: How Technology, Emerging Trends, and Innovation Will Shape the Industry in 2025 and Beyond
FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices
Guidance Shares Strategies to Address Transparency and Bias, while Providing Key Considerations and Recommendations on Product Design, Development and Documentation
Today, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device’s Total Product Life Cycle. The guidance, if finalized, would be the first guidance to provide comprehensive recommendations for AI-enabled devices throughout the total product lifecycle, providing developers an accessible set of considerations that tie together design, development, maintenance and documentation recommendations to help ensure safety and effectiveness of AI-enabled devices. This guidance complements the recently issued final guidance on predetermined change control plans for AI-enabled devices, which provides recommendations on how to proactively plan for device updates once the product is on the market.
“The FDA has authorized more than 1,000 AI-enabled devices through established premarket pathways. As we continue to see exciting developments in this field, it’s important to recognize that there are specific considerations unique to AI-enabled devices,” said Troy Tazbaz, director of the Digital Health Center of Excellence within the FDA’s Center for Devices and Radiological Health. “Today’s draft guidance brings together relevant information for developers, shares learnings from authorized AI-enabled devices and provides a first point-of-reference for specific recommendations that apply to these devices, from the earliest stages of development through the device’s entire life cycle.”
The draft guidance includes recommendations for how and when, in marketing submissions, sponsors should describe the postmarket performance monitoring and management of their AI-enabled devices. The proposed recommendations reflect a comprehensive approach to the management of risk throughout the device total product life cycle. The FDA encourages sponsors to engage with the agency early and often, and to use this guidance, once finalized, to guide their activities throughout the life cycle of the device, including during planning, development, testing and ongoing monitoring.
Importantly, this draft guidance also includes the FDA’s current thinking on strategies to address transparency and bias throughout the life cycle of AI-enabled devices. The draft guidance describes specific recommendations intended to help a sponsor demonstrate they have addressed risks associated with bias and provides suggestions for the thoughtful design and evaluation of AI-enabled devices.
Notably, this announcement is specific to AI-enabled devices. Today, the FDA also published draft guidance with recommendations regarding the use of AI to support development of drug and biological products. The publication of these guidances, among other actions, continues to demonstrate the agency’s efforts to provide transparency and to help ensure product safety and effectiveness while supporting innovation in this rapidly growing field.
The FDA is requesting public comment on this draft guidance by April 7, 2025. In addition to general comments, the FDA is specifically requesting public comment on the draft guidance’s alignment with the AI lifecycle; the adequacy of the recommendations to address concerns that may be raised by emerging technology such as generative AI; the approach to performance monitoring (including use of a performance monitoring plan as a means of risk mitigation for AI-enabled devices); the type of information about AI-enabled devices that should be conveyed to users and the most appropriate approach to deliver that information. The FDA will also hold a webinar on February 18, 2025, to discuss the draft guidance.
https://www.jamasoftware.com/media/2025/01/FDA-AI-Guidance.jpg5121024Jama Software/media/jama-logo-primary.svgJama Software2025-01-15 03:00:052025-01-13 12:27:06FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices
In this blog, we’ll recap a section of our recent Expert Perspectives video, “Integrating Safety of Intended Functionality (SOTIF) Into the Automotive Requirements Engineering Process” – Click HERE to watch it in it entirety.
Expert Perspectives: Integrating Safety of Intended Functionality (SOTIF) Into the Automotive Requirements Engineering Process
Welcome to our Expert Perspectives Series, where we showcase insights from leading experts in complex product, systems, and software development. Covering industries from medical devices to aerospace and defense, we feature thought leaders who are shaping the future of their fields.
In this episode, we speak with Dr. Hasan Ibne Akram on the topic of Integrating Safety of Intended Functionality (SOTIF) Into the Automotive Requirements Engineering Process.
Watch this video to learn more about:
The differences between SOTIF and functional safety
How to define and manage safety requirements addressing system limitations and edge cases
How to conduct a hazard analysis and risk assessment to cover intended functionality
Below is a preview of our interview. Click HERE to watch it in its entirety.
Kenzie Ingram: Welcome to Our Expert Perspective series where we showcase insights from leading experts in complex product systems and software development, covering industries from medical devices to aerospace and defense, we feature thought leaders who are shaping the future in their fields. I’m Kenzie Ingram, your host.
And today I’m excited to welcome Dr. Hasan Ibne Akram, an entrepreneur, computer scientist, book author, and CEO of engineering service company Matrickz based in Munich, Germany. With more than 17 years of experience in the automotive industry and working for two of the major German automotive OEMs, Dr. Akram brings a wealth of knowledge to this conversation. Today, we’re excited to showcase a discussion between Matt Mickle, Jama Software’s Director of Automotive Solutions, and Dr. Akram, on integrating safety of intended functionality, also known as SOTIF into the automotive requirements engineering process. Without further ado, I’d like to welcome Dr. Akram and Matt Mickle.
Matt Mickle: Thanks everyone for joining us today. My name is Matt Mickle. I’m the Director of Solutions for Automotive and Semiconductor at Jama Software. And I’m joined here today by Dr. Hasan Ibne Akram. Thanks very much for joining us today and answering some questions around integrating SOTIF into the automotive requirements engineering process. Dr. Akram, maybe we could start by just you telling us a little bit about yourself and your history with SOTIF and other industry standards and just a little bit about your background.
Dr. Hasan Ibne Akram: Absolutely. Thank you so much, Matt, for having me here. It’s amazing that we are having this conversation because this is very relevant today.
So my background in automotive started way back in 2005. So I was still a student, but I really wanted to go for a start-up. And back then, I landed a project with Continental. It was a braking system calculation project, and that’s how I got into automotive. And kept doing automotive stuff ever since.
And then, when I started my safety journey, I actually had no clue. So the first encounter to safety was a long time ago when I was actually working at a [inaudible 00:02:30] OEM as an external consultant. I was more responsible for the software. And during the lunch break, the functional safety colleague of that OEM, and in German, we call it FuSi, Funktionale Sicherheit, we used to call it FuSi. So I asked him, “What FuSi, the thing that you’re doing all the time? What is it about?” And quite condescendingly, he said, “We assume that whatever you guys are doing over there, every line of code, everything that you will do will go wrong.”
Akram: That was kind of like a light bulb moment for me. “Wow, that’s interesting. What happens when everything goes wrong? What do we do?” That was really my genesis of the functional safety journey. And SOTIF didn’t exist back then, was doing ISO 26262. And during my PhD, I was specialized in automotive cybersecurity, so cybersecurity and functional safety, I really wanted to bring them together.
And then, we realized, the automotive industry realized that, hey, there is something missing. Because with traditional safety, the definition of traditional safety is all about malfunction, if something goes wrong. Even when we’re doing security, it’s beyond malfunction, it’s all about attack now.Now comes autonomous vehicle, kind of like ADAS’s features, active distance control, automated emergency brake, active cruise control, and different levels of autonomy, Level 1, Level 2. The definitions came much later, but the idea of SOTIF was, hey, there’s something inherently required, there’s something required, something missing, inherently missing in the current standard because there can be hazards beyond malfunction.
It’s all about intention and this is where SOTIF was created, that we will talk about safety of the intended functionality. And my involvement, like you wanted to ask, my involvement with all these standards, I was following these standards before from the very ideas because the community is very, very close community. All the safety people in my podcast, I had Hans-Leo Ross, I had people who are the… Hans-Leo Ross even showed the birth certificate of ISO 26262 because he literally wrote the first lines and everything of ISO 26262. And I was privileged to be around these people who are actually shaping the future of these standards and how the engineering work will be done in the autonomous vehicle sphere and safety will be defined. So yeah.
Mickle: Nice. Well, that must’ve been quite enthralling at the time. So you mentioned that there was this gap sort of missing for functional safety and that SOTIF sort of filled that gap. Could you describe some of the key differences that are there between the standards?
Akram: Absolutely. So the key difference is, like I said, there was a gap. The gap was pretty evident, we’re talking about malfunction. If there is a fault, that fault would lead to a hazard, that’s ISO 26262, that’s traditional functional safety.
Now, what happens if there is nothing wrong in the vehicle, no malfunction, and we still have a hazard? So let me give you a metaphor. Imagine that you have a knife and you bought the knife. Your intention is to chop vegetables. So it’s a very sharp knife. The functionality is great, you’re chopping the vegetable, there is no malfunction, you’re chopping the vegetable. Now, by mistake, unintentionally, you cut your finger with it, it’s a hazard. Now, there is no malfunction still in the knife, the knife is 100 percent functional, it’s your intention that was to chop vegetables, but somehow, unintentionally, you cut your finger. And that’s where the safety of the intended functionality came in.
The famous example of such hazard is this high profile Tesla incident that happened, I don’t know, five, six years ago, where in a junction, because of the lighting condition, Tesla’s ADAS system could not recognize a truck that was passing the junction. And the driver happened to be watching Harry Potter and he didn’t pay attention. And this was fatal, I mean, the driver died. This was such a fatal accident. And there was nothing wrong in Tesla’s ADAS functionality, it’s just that this certain condition, there was no malfunction, this certain condition was not trained, and the ADAS system was not able to detect under certain lighting condition.
And that was the reason, but when we entered, when we started with this, it turned out vastly complex, the whole sphere of SOTIF, when you’re talking about the environment. I’ve just given you one example. So the environment is theoretically infinite. There can be infinite situations and there can be situations that we don’t know about. And the fact of the matter is, we don’t know what we don’t know. When you know something, you can take measure, that’s traditional ISO 26262. Now, we have this unknown unknown. You don’t even know what you don’t know. So that makes it extremely challenging and that’s why the whole process of autonomous vehicle development is going to be a continuous development process, we’ll have to continuously learn and incorporate safety and all those.
https://www.jamasoftware.com/media/2025/01/SOTIF-2.jpg10801920Matt Mickle/media/jama-logo-primary.svgMatt Mickle2025-01-14 03:00:482025-01-07 15:18:15Expert Perspectives: Integrating Safety of Intended Functionality (SOTIF) Into the Automotive Requirements Engineering Process
Jama Connect Features in Five: Live Trace Explorer
Learn how you can supercharge your systems development process! In this blog series, we’re pulling back the curtains to give you a look at a few of Jama Connect’s powerful features… in under five minutes.
In this Features in Five video, Francis Trudeau, Product Manager at Jama Software, will introduce viewers to Jama Connect’s Live Trace Explorer, which auto-detects risk by bringing comprehensive and detailed insights into your complex development processes.
Please note that Live Trace Explorer is currently in beta and available for all Jama Connect Cloud customers to try.
VIDEO TRANSCRIPT
Francis Trudeau: Hello and welcome to the segment of Features in Five. My name is Francis Trudeau, and I’m a Product Manager at Jama Software. This video is an overview of Jama Connect’s Live Trace Explorer feature. Note that Live Trace Explorer is currently in beta and available for all Cloud customers to try.
The Live Trace Explorer is like a real-time map of the V-model, helping you check coverage completeness and validity across your project. It actively tracks metrics to spot gaps and risks between engineering teams so you can address issues early. This leads to a smoother development process, higher quality products, and faster time to market. This capability is a significant step in our vision to provide metrics for managing the development process through data.
To enable the Live Trace Explorer, go to the Admin tab, navigate to the Details section, find the Live Trace Explorer line, click Configure, check the box, and save. Once enabled, the feature appears in Admin Project settings and is available for Organization and Project Admins.
Trudeau: If permission is granted by their admins, users with a creator license can fully utilize the feature to load and configure existing diagrams. Once enabled, the Live Trace Explorer can be launched by right-clicking a project component or set to create a focused diagram for the selected node or right-clicking the project route to generate a comprehensive diagram showing all components and sets in sequence from top to bottom.
The resulting diagram visually represents the V-model with stakeholder needs, system requirements, designs, and components on the left, and their associated verifications and validations on the right. Each tile represents a component or set connected by trace paths. These paths are gray if there are no relationships between items and adjacent tiles, or they turn green and red to indicate the number of healthy or suspect relationships between them.
On the right side, the Verifications and Validation branch shows the number of Test Cases linked to items within the container on the left, no matter where they appear in the project. At the bottom of each tile, you’ll find a metric representing the ratio of these Test Cases included in a Test Plan. On the requirements side, the top part of each tile displays stats, including the number of items by type and any open conversations.
Trudeau: In the bottom half, you’ll find coverage metrics, essentially the ratio of active relationships to expected ones as defined by the traceability information model. For example, the model indicates that each high-level requirement should have two relationships downstream. Out of my four high-level requirements, three are covered by validations, giving me 75% coverage. Two are related to mid-level requirements, resulting in a score of 50%. In the Actions menu, you can access configuration settings to customize what’s displayed and measured. You can globally turn off item types, exclude specific relationships from consideration, or you can configure each tile separately.
A common use case consists of configuring your diagram for disabling relationships you are not expected to have at an early stage of your project. Then you may want to disable lower-level requirement items and relationships pointing downstream to them. Once applied, the coverage and total score will update automatically. Make sure to save your diagram once you have configured it to your liking. Live Trace Explorer updates in real-time, so any changes to project data instantly affect the metrics. For example, I can address a gap by clicking on the incomplete coverage. This will open Trace View where I can then establish a relationship to a mid-level requirement. Back in Live Trace Explorer, the metrics and total score summarizing all coverage will be updated after a refresh. You can keep a record and share these metrics by exporting a diagram as a PDF from the Actions menu at the top.
If you’d like to learn more about how Jama Connect can optimize your product, software, and systems development processes, please visit our website at jamasoftware.com.
https://www.jamasoftware.com/media/2024/12/Live-Trace-Explorer-FIF-2.jpg10801920Francis Trudeau/media/jama-logo-primary.svgFrancis Trudeau2025-01-03 03:00:562024-12-19 09:59:37Jama Connect® Features in Five: Live Trace Explorer™
2025 Expert Predictions for Aerospace and Defense: AI, Sustainability, and the Next Frontier
Aerospace and defense are at the cusp of revolutionary changes, driven by advancements in artificial intelligence, autonomous systems, sustainable technologies, and digital transformation.
In part four of our annual predictions series, Vance Hilderman, CEO at AFuzion and Jama Software’s industry experts Cary Bryczek , Director of Solutions & Consulting; Karl Mulcahy, Global Sales Manager of Aerospace & Defense and Matt Macias, General Manager of Aerospace & Defense share their insights on the trends, challenges, and innovations shaping the future of aerospace and defense.
From the integration of AI in autonomous systems to the adoption of digital twins for operational efficiency and the pursuit of sustainable practices, these insights offer a glimpse into the opportunities and disruptions that lie ahead. Whether it’s navigating cybersecurity challenges or adapting to shifting geopolitical conditions, this year’s predictions provide a roadmap for industry leaders to thrive in 2025 and beyond.
We like to stay on top of trends in other industries as well. Read our predictions for Industrial & Consumer Electronics (ICE) HERE, Automotive HERE, and Semiconductor HERE – Plus, stay tuned for future topics, including Medical Device & Life Sciences, and AECO.
Editor’s Note: Responses reflect a mix of British and American English, depending on the respondent.
Question 1 – With the rising integration of AI, machine learning (ML), and autonomous systems, how do you foresee these technologies reshaping aerospace and defense operations? What are the most promising applications and potential challenges?
Vance Hilderman: AI & ML are already used for ground planning, flight plan optimization, flight deck monitoring, and assists. Militaries are using AI onboard UAVs (Unmanned Aerial Vehicle) and fighter aircraft but real-time AI on commercial aircraft is not yet allowed for safety-related operations.
Cary Bryczek: We will see an explosion in systems engineering utilizing AI. AI will not only be used to write requirements but decompose the requirements into lower-level requirements, create architecture models and establish traceability throughout. It’s beginning to happen right now! AI assistants for systems engineers will create enormous time savings so the actual engineering can be performed.
Karl Mulcahy: AI/ML I’m sure is of interest to these companies to make internal development practices more efficient, but also to enhance their offerings e.g., AI monitoring for better insights/decision making on a battlefield.
However, with ongoing security aspects a constant concern for sensitive projects within the defence world particularly, it may require more maturity and capabilities within customer environments for internal efficiency gains.
Matt Macias: The aviation industry is already demonstrating prototypes leveraging AI and autonomous operation with a large number of new and existing companies developing transformational vehicles to provide new ways for people and goods to utilize airborne mobility’s advantages. There is a strong desire to bring the consumer faster, safer and more cost-effective ways to travel. We see many new startups and innovative ideas in the work, which is very exciting. We also see a great rise in the pursuit of novel, innovative cyber-system approaches and new vehicle designs, propulsion and operations.
In the defense world we see AI/Autonomous systems enabling disruptive changes in the systems and total architectures utilized for security. These new technologies are enabling breakthroughs in new missions and exposing unexpected vulnerabilities. We saw this clearly in Ukraine with the successful use of inexpensive, modified consumer drones defeating far more expensive systems. We also see this in the changes and cancelations of some larger DOD systems programs, where there appears to be a shift in focus to very different, lower-cost systems. For example, drones that operate in a “constellation” of unique, adaptable, or “swarms” of “expendable” or essentially single-use systems that can potentially overwhelm more traditional manned or legacy systems. This is not only changing the approaches to military strategy, but it is revolutionizing the development of tomorrow’s military systems, leading (as in commercial aviation) to an explosion of new ideas and new programs. We also see a rapid growth of disruptive companies taking market share from traditional defense contractors.
All in all, this is a very exciting time for anyone who is interested in aviation, space and defense innovation.
Question 2 – As a follow-up question: Do you have any concerns or anticipate any negative impacts as it pertains to AI & ML?
Hilderman: When used on the flight deck for real-time flight controls, it needs to be certified which is not yet possible for commercial aviation. We’re working on this.
Bryczek: I would say none to be honest. The technology is there to protect intellectual property. Perhaps the only concern I have is do we have the energy infrastructure ready to drive some of the computing power behind it all.
Macias: Currently, the most immediate negative impacts of AI & ML is the disruption of well-established commercial markets and in the case of defense, the unexpected vulnerability of military systems that we have invested heavily into ensure our security.
We don’t know yet how advanced air mobility systems might change the flow of people and goods around our cities, but it is likely that not likely in 2025. In the mid-term future, we will see disruptions as we seek new norms, such as increased noise, safety challenges, privacy challenges, etc. We can also see that the major militaries of the world are very concerned about countering the asymmetric threats autonomous systems pose to our larger defense platforms, likely to accelerate as AI is applied in the future.
Question 3 – As global demand for sustainable practices intensifies, what innovations in product design, materials, or manufacturing processes do you think will most significantly impact sustainability efforts in aerospace and defense?
Hilderman: eVTOL. [Editor’s note: Electric Vertical Take-Off and Landing (eVTOL) aircraft are a type of VTOL (Vertical Take-Off and Landing) vehicle that use electric power for vertical takeoff, landing, and hovering. Unlike traditional VTOLs, eVTOLs rely solely on electric propulsion.]
Bryczek: We are going to continue to see more research and development efforts into alternative geological materials to mitigate the need to use rare earth elements. Systems will need to be redesigned, or new systems built altogether that utilize different materials. It’s not just global political unrest that is driving this but also socio-environmental resistance to the mining/extraction process that ruin the environment.
Mulcahy: Better collaboration across teams using tools to capture outcomes, integrate data sets, and ensure better decision-making/more efficient ways of incorporating science and research into the manufacture of products.
Macias: Aerospace and Defense is an industry that has struggled greatly with achieving solutions for sustainability. A significant innovation focus is being applied to this ongoing challenge. We can see major positive impacts already in more efficient structures (increased use of carbon fiber composites and advanced designs) and advancement in the efficiency of traditional propulsion systems. In work and over the horizon there is a strong desire to harness advanced, model-based design approaches (including AI, generative design, MDO, MBSE), and advanced manufacturing automations (3D printing, advanced robotics, etc.) to enable dramatic innovations that will increase the efficiency of flight and other operations.
However, what the industry most dearly seeks is a sustainable power source for A&D systems. This will have great value as these systems consume a great deal of energy and in the case of defense systems, the cost of getting fuel to the point of need is extremely high. The challenges of electrification, sustainable aviation fuels (SAF), hydrogen propulsion, etc. continue to be a major focus of the A&D industry but also continue to present very significant challenges of affordability, reliability, power density/weight, and the logistics of fuel delivery.
Question 4 – Cybersecurity remains a top priority in aerospace and defense. What proactive steps do you believe the industry should take to strengthen security measures, particularly in software development and data management for connected and autonomous systems?
Hilderman: Mandate formal usage of DO-326A and ED-202A for cybersecurity within Avionics.
Bryczek: We already have terrific security policies and guidelines as Vance has pointed out that both the US and Europe have crafted. Developers need to be held accountable to follow security by design and to leverage zero-trust architecture. Still too often do I see security performed as an afterthought.
Macias: Security assurance is critical as we advance our use of autonomous systems and integrated data networks. This is and will remain a subject of constant focus, priority and challenge. The application of careful and advanced cybersecurity approaches must be a primary focus of all parts of the A&D system lifecycle including IP protection and security in operational data. As our systems become more intelligent and as the leverage is greater and greater computing power, this will only increase.
Question 5 – Given the shift toward digital transformation, what role do you see digital twins and simulation technologies playing in enhancing operational efficiency, project accuracy, and training in aerospace and defense?
Hilderman: Aircrafts are increasingly automated meaning less pilot involvement which means less onboard “practice;” this means simulation-based training is even more important.
Mulcahy: With more complex products being designed and worked across companies to deliver a larger product/initiative, going digital will be important to ensure alignment.
It will be important to ensure ways to share data seamlessly across tools to understand wider impacts, relationships and identify risks at an earlier stage.
Macias: The A&D industry is seeking the total usage of comprehensive digital twins that harness simulations in near real-time to instruct all aspects of a system’s lifecycle. Simulation driven, model-based development when harmonized into a comprehensive digital twin will enable dramatic breakthroughs in program efficiency, quality, and innovative capabilities. Because of the dramatic increase in ability of the engineering teams to cycle through massive numbers of virtual design and operational scenarios leading companies are enabling dramatic improvements in optimization and deep insights into the function of the designed systems early and throughout ongoing design changes.
This will extend to every aspect of the lifecycle, first into manufacturing and sustainment/service, mission development and operations health monitoring. We can envision a future where every operation of a system/vehicle is both simulated before it happens and after to assess the most efficient operation and the overall health of the system, safety of its occupants/environment. This can also have a significant impact on sustainability if the digital twin is harnessed to optimize operations for minimum energy consumption and maximize life of the system.
Question 6 – How do you anticipate changing geopolitical conditions and regulatory demands influencing the development of next-generation aerospace and defense products? What strategies should industry leaders consider to remain agile and compliant?
Hilderman: Defense demands will only grow; Europe will need to greatly increase spending, and USA will need to counter increased China spending.
Bryczek: In the defense industry, meeting the mission requirements and providing capabilities quickly to the warfighter trumps regulatory safety compliance requirements. Since there is no “certification” activity as in civilian aerospace systems, there is less burden on development practices. I see very little regulatory changes that will greatly impact defense. On the civilian side, regulations continue to evolve still very slowly. Leaders need to remain agile with their business strategy and align with what the political conditions offer. If there is a way to morph your product to a different market; then be bold and make it happen.
Mulcahy: With the rise of more worldwide conflicts, especially in Europe and the Middle East, more countries are spending more of their GDP on defence spending.
In today’s world, defense now goes more than just weapons, but also into space, cyber security and of course ensuring systems are secure and reliable.
New threats require new solutions to help mitigate these threats. That’s where more companies will develop more solutions and start-ups will emerge.
We often hear of a grey area in the UAV world in terms of regulations, but with more focus on the SORA (Specific Operations Risk Assessment) / SAIL (Safety Assessment Integrity Level,) it will be interesting to see what standards emerge with more civilian/military uses for UAVs for both attack and defence purposes.
Macias: As the broader world adjusts to an accelerated rate of change, we will need to introduce innovative solutions faster and leverage solutions from global partners. This will demand secure, virtual collaboration methods, new ways of joint development while protecting IP and data security, and new standards for safety, communication, and joint operations. Industry leaders should continue to seek secure, virtual collaboration methods that can bring global/multi-disciplinary teams together and ensure harmonized efforts.
Question 7 – Are there any additional insights you have regarding predictions, events, or trends you anticipate happening in 2025 and beyond?
Hilderman: Demand for engineers is greater than supply and this will only worsen.
Mulcahy: More innovation in the UAV / Advanced Air Mobility (AAM) markets, but also more focus on the security of these solutions and the supporting infrastructure and regulations. It will be interesting to see how this combines with AI to develop fully autonomous and intelligent UAVs for civilian/military use cases. The need for larger companies to become more digital, deliver faster, and streamline operations will continue to be a focus.
Macias: The recent past has shown that innovative concepts are accelearating at such a high pace that we are continuously being surprised and amazed at new possibliities and impacts. The industry as a whole must seek faster awareness, greater agility and increase creativity to respond, leverage, and compete in the face of such dynamic times for Aerospace and Defense systems.
https://www.jamasoftware.com/media/2024/12/2024-12-18-predictions-ad-2025-1-1.png5121024Jama Software/media/jama-logo-primary.svgJama Software2025-01-02 03:00:122024-12-20 15:37:192025 Expert Predictions for Aerospace and Defense: AI, Sustainability, and the Next Frontier
In this blog, we recap our webinar, “The New ARP4754B: Tips for Engineers & Quality Teams” – Click HERE to watch it in its entirety.
Navigating the updates to ARP4754B can be challenging.
Understanding new safety analysis methods, validation and verification flexibility, and strategies to mitigate unintended behaviors is crucial for advancing aerospace development and ensuring compliance.
Join us as Cary Bryczek, Director of Aerospace and Defense Solutions at Jama Software, shares practical tips for engineers and quality teams to navigate the most impactful changes in ARP4754B.
Gain Insights On:
Changes from ARP4754A to ARP4754B
Model-Based Safety Analysis (MBSA) and Cascading effects Analysis (CEA)
Identifying and mitigating unintended system behaviors
Tying your safety analyses to requirements in Jama Connect
The updates to verification and validation methods
Below is an abbreviated transcript and a recording of our webinar.
The video above is a preview of this webinar – Click HERE to watch it in its entirety!
VIDEO TRANSCRIPT
The New ARP4754B: Tips for Engineers & Quality Teams
Cary Bryczek: We’re going to have fun talking about the changes from ARP4754B revision A to revision B. We’ll spend some time a little bit more deeply on its emphasis on model-based design and safety. I’ll talk about enhanced integration of safety and requirements management and some of the changes to validation and verification. At the end, we’ll have some time for Q&A.
A quick refresher on what ARP4754B is. Its title is Guidelines for Development of Civil Aircraft. It’s an industry guideline developed by SAE International that provides recommended practices for the development of complex civil aircraft and systems. It outlines a structured systems engineering process for the integrating of hardware, software, and human factors to ensure safety, reliability, and performance across the system lifecycle. The document emphasizes traceability, verification, and validation from initial concept through to certification with a strong focus on meeting regulatory safety and design assurance standards.
ARP4754B also aligns and is used in conjunction with other key aerospace standards like DO-178C and DO-254 offering detailed guidance on how to meet safety and certification requirements in the context of modern integrated aircraft systems. ARP4754 revision B is meant to expedite consistency with ARP4761 revision A, the safety assessment process, which was it was released on the same day in December of 2023.
The guideline describes generic aircraft system development process, which establishes a framework for discussing the process. ARP4754B doesn’t imply a preferred method or process, nor does it imply a specific organizational structure. At its simplest, it emphasizes the flow down of intended aircraft function through the system requirements management process and allocation of function to systems, subsystems, and hardware and software items.
Integral processes in the context of 4754B refer to key processes that are interwoven throughout the entire development lifecycle of aerospace systems from concept to design, integration, verification, and certification. Now, these processes ensure that various engineering disciplines, your systems engineering teams, your hardware and software engineering safety are fully integrated, aligned, and contribute to the overall success of the project.
Bryczek: This diagram from 4754B outlines the key stages of the aircraft system development process and provides a framework for understanding how safety is integrated into each stage. The safety are the ones that are in the lightest white or gray. The standard approach ensures that the safety risks are identified, analyzed, and mitigated early in the design process, and are continuously assessed throughout the system lifecycle.
I want to point out that lifecycle phases really are iterative and independent. 4754B emphasizes that the phases of system development aren’t strictly linear. For example, design and development may loop back to earlier phases such as the requirement’s definition. If issues are found during those later stages, sort of this iterative approach ensures that safety concerns can be identified and corrected throughout the lifecycle.
You’ll also notice that safety and hazard analysis is integrated throughout the development phases. Safety assessments are continuous activities throughout the development process. Safety considerations such as your functional hazard assessments, your fault tree analysis to your cascading effects analysis are embedded within multiple phases, particularly the design, development, and verification phases.
Let’s get to the meat of what has changed. So ARP4754B builds on the foundation laid by 4754A but offers a much more structured, detailed, and modern approach to developing complex aerospace systems. This is in response to the increasing complexity of our modern aircraft, tighter safety requirements, and evolving certification processes, particularly the need for rigorous system integration, traceability, and safety assessment practices. It provides greater clarity around the development assurance levels and how they relate to the overall system and safety requirements.
Bryczek: While A provided a basic framework, B refines the application of DALs throughout the system lifecycle. B expands the understanding of development assurance levels in the context of aircraft and system development, and it places a greater emphasis on safety, traceability, and integration across the lifecycle stages. The updated standard provides a more comprehensive guidance on managing the DALs and aligning the safety assessments with the system requirements, and it ensures that development processes are rigorous enough to meet the increasing complexity of the modern aircraft systems.
With the increased use of model-based techniques, 4754B highlights the benefits of using models to perform safety assessments. It recognizes that simulation-based safety analysis can help engineers assess the safety of complex integrated systems much more efficiently by modeling different failure scenarios and responses, so the standard supports using simulation tools to model those failure scenarios and validate the robustness of safety-critical systems. And this all just improves the accuracy of safety analysis, and it helps identify the potential issues earlier in the design process.
https://www.jamasoftware.com/media/2024/12/The-New-ARP4754B-Tips-for-Engineers-Quality-Teams.png9001600Cary Bryczek/media/jama-logo-primary.svgCary Bryczek2024-12-30 03:00:462025-01-24 14:39:50[Webinar Recap] The New ARP4754B: Tips for Engineers & Quality Teams
![[Webinar Recap] Transform Engineering Processes: Bridge Gaps Between Teams and Tools Effectively](https://www.jamasoftware.com/media/2025/01/Transform-Engineering-Processes.png "[Webinar Recap] Transform Engineering Processes: Bridge Gaps Between Teams and Tools Effectively")
