Tag Archive for: Requirements & Requirements Management Page 23
Tag Archive for: Requirements & Requirements Management
In this video, we demonstrate the Baselines feature in Jama Connect®.
Jama Connect Features in Five: Baselines
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 the powerful features in Jama Connect… in under five minutes.
In this Features in Five video, Jama Software® subject matter expert Julie Goodner, Senior Product Manager, demonstrates Baseline capabilities in Jama Connect.
VIDEO TRANSCRIPT:
Julie Goodner: Hi. My name is Julie Goodner. I’m a Senior Product Manager here at Jama Software. In this video, I will walk you through Baselines in Jama Connect. I’ll cover what a Baseline source is, what Baselines are, when to create one, and some of our new Baseline features.
A Baseline source in Jama Connect is a collection of all versions of the requirements or other items that have been selected for a Baseline. A Baseline in Jama Connect is a snapshot in time and you can create a baseline to capture any milestone. In addition, a Baseline is also automatically captured when a review—or a revision to a review—is created.
A Baseline allows our users to capture the state of their content in alignment with key points in their product development cycle, such as during peer reviews, at key approval gates, or when generating documents from Jama Connect. In addition, utilizing Baselines allows our users to compare items as they change over time.
Goodner: With Baseline sources, you can see if the Baseline or Review contains signatures, see Baseline statuses, quickly navigate to a Review, or do a comparison summary between two Baselines and export the redlined report.
With Baselines, you can add electronic signatures, compare two Baselines with redline edits from within Jama Connect, compare items in your Baseline items to their current state in the project, add a status, and navigate to the Baseline version in the project view.
Goodner: From the Baseline source, you can see high-level information about its corresponding baselines that used to be hidden within a baseline details section. When selecting two Baselines, you can choose to do a comparison. This comparison summary model informs you have any updates that have been changed. You can also export that report and view the red line edit.
From a Baseline in the List View, you can see what relationships, categories, or other metadata were used to associate with the items at the time of the Baseline. When selecting the link in a Baseline, it will take you to the historical view from within the project.
From the Baseline Document View, you can choose to compare and see the differences in redline edit within Jama Connect, no longer needing to download reports.
If you would like to learn more about Jama Connect, how Jama Connect can optimize your product development process. Please visit our website at jamasoftware.com. If you’re already a Jama Connect customer and would like more information about Baselines, please contact your customer success manager or a Jama Software consultant.
In this blog, we discuss INCOSE’s System Engineering Handbook V5. To download this handbook, click HERE.
Empowering Engineers: Exploring INCOSE Systems Engineering Handbook V5
What is INCOSE?
The International Council on Systems Engineering (INCOSE) was founded as a collaborative effort to bring systems engineers together and provide them with resources to progress in their field. Their mission is to cultivate a strong network of professionals, supply educational materials, and create tools that will help systems engineers be successful. INCOSE is dedicated to elevating the global profile of the systems engineering (SE) profession.
According to INCOSE, the Systems Engineering Handbook “shows what each systems engineering process activity entails in the context of designing for affordability and performance. On some projects, a given activity may be performed very informally (e.g., on the back of an envelope, or in an engineer’s notebook); or, on other projects, a more formal response is required with interim products under formal configuration control.”
The handbook provides assistance for individuals of various backgrounds and experience levels, such as those just beginning their systems engineering journey, engineers from different disciplines needing to apply the principles of systems engineering, and experienced engineers looking for a handy reference.
INCOSE Systems Engineering Handbook V5
The newly released INCOSE Systems Engineering Handbook V5 is a comprehensive guide to the discipline of SE which outlines the current best practices and serves as an informative reference for understanding SE in terms of content and application.
Some of the topics included in the latest handbook include:
Elaboration on the key systems life cycle processes described in ISO/IEC/IEEE 15288:2023;
Chapters covering key systems engineering concepts, system lifecycle processes and methods, tailoring and application considerations, systems engineering in practice; and
Appendices, including an N2 diagram of the systems engineering processes and a detailed topical index.
Applying INCOSE Standards Using Jama Connect Advisor™
System engineers focus on making each of the individual systems work together into an integrated whole that performs as expected across the lifecycle of the product. In order to deliver successful products, they need the right user needs and requirements. Efficient, precise, and professionally written requirements form the foundation of the product development process so that various teams (design, software, and hardware systems) can all work together with a shared and clear understanding of the project goals.
Jama Connect Advisor™ is a state-of-the-art requirements authoring guide and optimizer powered by natural language processing for engineering that helps a system engineer or a product developer write effective, well-organized requirement specifications based on industry-accepted INCOSE rules and the EARS (Easy Approach to Requirements Syntax) notation.
In part two of this two-part video series, will demonstrate the latest solution offerings for Medical Device & Life Sciences in Jama Connect®. Click HERE for part 1 and HERE to watch our related and full-length webinar, “Elevating Your Medical Device and Life Sciences Product Development Processes with Jama Connect.”
Jama Connect Features in Five: Medical Device & Life Sciences Solution 2.0 – Part 2
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 the powerful features in Jama Connect… in under five minutes.
In part two of this two-part Features in Five video series, Jama Software® subject matter expert Vincent Balgos, Director, Medical Device Solutions, continues his demonstration of the latest solution offerings for Medical Device & Life Sciences in Jama Connect.
Click HERE for part 1 and HERE to watch our related and full-length webinar, “Elevating Your Medical Device and Life Sciences Product Development Processes with Jama Connect.”
VIDEO TRANSCRIPT:
Vincent Balgos: Hi. My name is Vincent Balgos, and I’m the Director of Medical Solutions here at Jama Software. In this video, I’m going to talk about our updates to our Medical Device and Life Sciences Solution 2.0. For the agenda, there are quite a few improvements I’d like to share with you today.
So the first thing I want to show is our Jama Connect Advisor™ example data. Released in 8.80, this new feature enables EARS and INCOSE rules for requirement quality authoring. Additional licenses are required, but wanted to share some of the capabilities examples right out of the box. So as you can see here, what we’ve shown, is, you know, the general use case description, but also an example requirement with the Jama Connect Advisor output. Again, this is a nonfunctional screenshot. We just wanted to share some of the information that you may see when having Jama Connect Advisor. Here’s, for example, for a green status, which means generally a good requirement, but let’s take a look at what a yellow requirement or maybe something that may need some rework and you can see which of the rules, particularly INCOSE, that is now flagged that is, you know, has some potential issues. And then the same is true with our red level of requirements.
So again this is potentially a useful tool to kind of share while authoring requirements for your project.
Balgos: The next use case that we’d like to talk about is the industry standards trace. So in the standards use case, the first thing I want to share is this relationship rule diagram. As you can see here, we have user needs trace to system requirements, which is, you know, aligns with [21 CFR] 820.30, but also we have this new item type called standards reviewed is now traced to system requirements.
If you upload your standards into Jama Connect, what we can see for this particular item type is that we’ve identified now the standard, the clause number, the clause text, and identified does the standard apply for this particular project. What’s nice about once this is in Jama Connect, I can now actually do a trace downstream to the system requirement. Note, this project does not provide any standards due copyright issues, customers won’t need to vision their own standards for use and apply appropriately. The last thing we want to talk about is really the reports on this medical device framework update.
Balgos: What I wanted to share is if I go into the admin area and I take a look at the reports, you can see now that we’ve now had the ability to upload and, you know, manage our own reports, but we’ve provided some additional categories and information to help organize the many reports that we have. As you can see here, we’ve identified some trace reports and some new SaMD reports. So if I go back to the project and let’s take a look at, let’s say, system requirements, I want to show you a new trace report that shows requirements to verification-only events. So for example, let’s say if we go on to, let’s say, our subsystem requirements that we have here I’m gonna pick this one.
I’m going ahead and go at export. Again, this is available now into the Medical Device Framework 2.0. What I want to show you is requirements to verification trace report. So if I go ahead and hit run, create a report, I’m gonna download it, and then what wanna share is this new trace report that we have, which now shows you the requirement, the verification test case associated with the requirement, But in addition, the latest test run and its test result status.
Balgos: So this helps clearly identify the requirement to verification traceability that’s may needed and they may be able to submit to your DHS. We have a similar one called the user needs to validation transport that falls the same above. The other thing we wanted to show is that we’ve added a couple popular and useful GitHub reports to this solution update. These are located up in our run reports area where we actually now included the test results report group by test case and the test result report grouped by test cycles, which are really, really helpful for understanding test management scenarios.
Okay. That’s for the general update for the the standard medical device framework. We have an additional updated solutions such as software as a medical device, research use only, and our new self-guided onboarding framework. So we definitely encourage you to look at that further.
Please contact your Jama success manager or consultant to learn how to implement these new solutions at your organization.
In this blog, we recap our webinar, “Effectively Managing Cybersecurity in Jama Connect® for Automotive and Semiconductor Industries”. Click HERE to watch the entire thing.
If you’re in the automotive or semiconductor industries – cybersecurity is likely top of mind.
In this webinar, attendees will see exactly how to:
Define cybersecurity goals, requirements, and concepts
Conduct threat analysis and risk assessment
Establish traceability to the architecture design and verification/validation of cybersecurity measures
Document the cybersecurity case and manage changes
Identify and classify assets for the subject of the cybersecurity case
Discover how Jama Connect can help you optimize your cybersecurity processes and stay ahead in the Automotive and Semiconductor industries.
Below is an abbreviated transcript of our webinar.
Effectively Managing Cybersecurity in Jama Connect® for Automotive and Semiconductor Industries
Kevin Dibble: Well, first I’m going to talk about what we’re going to talk about, so these are the topics that we’re going to cover. And without reading this slide, really we’re going to cover the development life cycle of creating, the example we’re going to use is a 48-volt power assist system. You might also think of it as a battery management system. And so I’ll go over the agenda, but what you can see on the is we’re going to cover everything from the planning in the case through the TARA work and down through the left side of the V and some of the right side of the V activities as well. And here’s how we’re going to do it. First, to get everyone oriented to 21434, we’re going to talk about the standard itself briefly and highlight some of the benefits of implementing a cybersecurity case in a tool, in a requirement management tool.
Then we’ve got some workflows to look at, the steps of the development life cycle for 21434 from the perspective of an OEM and then again from the perspective of a tier one. And then Matt is going to show the work products, the traceability, and what we’ve talked about at the beginning actually in the tool in a built-out project for a 40 volt power assist system. And then we’ll finish with some takeaways. So that’s what’s on tap for today. And so I want to make the case for managing cybersecurity and the cybersecurity case and the work products in a requirements management tool. So I’m going to just look at each one of these points. The first item is to improve collaboration between OEMs, tier ones, and tier twos.
Jama Connect supports ReqIF, which can be used for bidirectional communication of requirements, item definitions, et cetera, as well as updates to those assets. And so it supports better collaboration. One thing that Jama promotes is this idea of trace as you go. So traceability is not an afterthought handled by a requirement engineer at the end of the project that takes weeks to implement on a complex project. It’s something that the engineers are doing as they’re creating the requirements tracing to parent requirements, design blocks for requirement allocation, et cetera. And so this tool supports that traces you go methodology along with some views of the progress of tracing.
Dibble: The impact analysis is a powerful tool when you trace as you go and the requirements left and right side V model assets are linked together. Then running impact analysis reports as changes come in midstream in programs, which they do in automotive for sure. You get that as a benefit. Like I mentioned earlier, requirements allocation. So allocating requirements to design blocks or interconnecting the requirement management system to design tools and doing allocation in those tools like Design Architect gives you some powerful analytics like test coverage reports automatically generated. Also connecting the tools through connectors gives you a toolchain view instead of disjointed tool. And finally, Jama Connect offers some analytics that we’ll see some of these in the demo that will give you a very clear indication of where you are in the project, especially in terms of requirements that are allocated, tests that have been covering requirements, and so on and so forth.
So with that, I’m going to orient everybody to 21434 in terms of the V model, which it’s centered on, and two other standards that you may be more familiar with. ISO 26262 and Automotive ASPICE. And so just a couple things here. If you are familiar with these other two standards, you’ll see that 21434 fits nicely alongside and that was intended by the ISO folks that did the standard. They very much aligned it with ISO 26262, and really even in nomenclature. So whereas in safety we have safety goals, in security we have security goals, in safety, we have the HARA, the hazard and risk assessment. In cybersecurity, we have the TARA, threat, and risk assessment, and so on and so forth. And also the common supporting processes like configuration management, change management, project management, document management, even confidence in use of software tools that all of these standards rely on are again repeated and required in 21434.
Dibble: So just some basic organization of the standard in terms of the V model and then we’ll look at it in one more view in terms… this is directly out of ISO. And at Jama, we’ve added some color coding and I’m going to explain that. And so if you’re not familiar with this view, 21434 is oriented by clauses and sub-clauses. And so you can see the clause here like clause five is organizational, that’s policy and tool management and quality management and things. And then clause six, et cetera, and on down, that’s how this is organized. Jama has capabilities that support these sub-clauses. And so we’ve used a color system here to highlight that. The sub-clauses that are colored in green are fully supported and in fact, recommended to implement in Jama. The yellow are optional, they could be implemented in Jama.
And for most of these, we have customers that are implementing these types of things in Jama, but they also use other systems to implement them. And then this kind of yellow-green is partially supported. Jama can support some of the requirements but not all. And then of course red is not recommended for support in Jama and it’s usually house and other tools or things like production tools, et cetera. Okay, so what Jama brings to the table in terms of capabilities to support these green and yellow items are document building and generation. So the document management functionality as well as the exporting functionality. As you’ll see in the demo, you can export what has been entered in a requirements tree or in one view can be exported into a more of a document-style view that perhaps suppliers or other people might want to consume.
It has built-in collaboration tools for reviewing, which is very important because 21434, like 26262 requires review records, and all the work products are reviewed. Traceability and impact analysis, I already talked about. VNV verification and validation with the test manager tool as well as interconnections to other tools and analytics. There’s a nice support for the right side of the V activities. Using a common tool does bring alignment between different engineering disciplines, whether it’s hardware, software in systems, or if it’s QA tests and V&V activities versus development activities. Release planning and coverage through dashboards and status metrics and then of course baselining and reuse and whatnot.
And so this slide shows all of the items from the previous slide that were recommended or are optional and just shows how they would look in a project tree format. Again, Matt’s going to go through most of these items for our 48-volt power assist item that we’ve built out. Okay, one of the important features of Jama Connect as well as any requirement management tool is the ability to develop traceability. Here we’re showing the traceability model, which is their traceability models come with the product, but they also can be customized. And then I’ve got a little animation here to show for cybersecurity, some of those standard parts and tying them back to the standard. So for instance, in the model, I don’t know, it’s small print, but you can probably see cybersecurity asset, attack path, damage scenario, threat scenario. Those all correspond to the TARA and here are the sections that those are discussed in.
In part two of this two-part blog series, we continue the overview of our recent whitepaper, “How to Achieve Higher Levels of the Capability Maturity Model Integration (CMMI) with Live Traceability™” Click HERE for part one of this blog and HERE to read the entire whitepaper.
How to Achieve Higher Levels of the Capability Maturity Model Integration (CMMI): Part 2
Benefits of Live Traceability™
The main benefits of Live Traceability across best-of-breed tools are as follows:
Reduce the risk of delays, cost overruns, rework, defects, and recalls with early detection of issues through exception management and save 40 to 110 times the cost of issues identified late in the process.
Achieve CMMI Level 2 maturity for Requirements Management with no after-the-fact manual effort.
Eliminate disruption to engineering teams that continue working in their chosen best-of-breed tools with no need to change tools, fields, values or processes.
Increase productivity and satisfaction of engineers with the confidence that they are always working on the latest version, reflective of all changes and comments.
Another core goal of CMMI Level 2 is to involve stakeholders in the requirement review and approval process (see table below). Let’s examine how companies achieve this goal either through meetings or online reviews.
CMMI Level 2 (Managed) Requirements Management
There are two ways to implement this practice: meetings or online reviews. Most engineering organizations still address stakeholder approvals through large and lengthy meetings that involve all relevant engineering disciplines scrolling through the requirements document for feedback. This is a highly inefficient approach that negatively impacts engineering productivity, morale and fails to capture relevant comments, feedback, revisions, and approvals from stakeholders given the format. More mature engineering organizations have brought the review and approval process online to improve the quality and timeliness of feedback, capture all version and approval histories online, and improve engineer productivity and morale. Let’s examine how companies have brought reviews online with Jama Connect® Review Center.
Review Center allows teams to send product requirements for review, define what’s required, invite relevant stakeholders to participate, collaborate, and iterate on resolving issues and approving agreed-upon requirements. By simplifying the revision and approval process, Review Center streamlines reviews and facilitates collaboration, giving stakeholders easy access to provide feedback where required. Jama Connect enables both informal and formal online review processes to support this CMMI best practice.
The formal review process enabled by Review Center is shown below:
Review Center enables teams to define a review, invite participants, gather and incorporate feedback from relevant project stakeholders, iterate, track a review’s overall progress, and monitor progress and capture approval signatures if required. Reviewers can respond to a conversation that’s taking place, as well as mark items as “Approved” or “Rejected” to complete the review. Inside Review Center, reviewers can also add electronic signatures to reviews in order to comply with regulatory standards. Jama Connect captures the date and time of completed reviews for auditing, tying each signature to the document under review.
Informal Reviews
Organizations that still want the quality review aspects of Jama Connect but are not bound by producing formal documents of requirements may take a more iterative approach. A “rolling” review is a review that changes the scope of which requirements are included in each revision. For example, each requirement has a “state” field – Draft, Ready for Review, or Approved. In the project side of Jama Connect, requirement owners will mark requirements they feel are “Ready for Review.” Moderators can also edit requirements directly in the review based on feedback from Approvers. Using a Jama Connect Advanced Filter, a review will be started by pulling in only requirements that are marked “Ready for Review.” Using this methodology, the review is much smaller in scope and can typically be completed faster. On a regular cadence, the moderator will review feedback, make changes to requirements as necessary, or potentially update the requirement status to “Approved” if the required stakeholders have approved the requirement. When publishing a new revision, Jama Connect will pull new requirements into the review and cycle out requirements that are “Approved” (these requirements no longer meet the filter criteria of state = “Ready for Review”). This allows teams to review requirements on a regular cadence — or sprint — and cycle requirements into the review when they are ready for feedback and out of the review when they are “Approved.” Almost any item of content you create in Jama Connect may be sent for a review, including requirements, design, test cases, test plans, and test cycle results.
“Review Center is facilitating communication. It has ensured a shared view of the world and agreement from all stakeholders. There are no surprises anymore. Jama Connect enables us to review documents and make decisions easily with everyone coming to a shared conclusion. If we compare it to reviewing the spreadsheets and Word documents versus doing a review in Jama Connect Review Center, it’s about an 80% reduction in time, for sure.” – Craig Grocott, Head of Systems Engineering
To achieve CMMI Level 2 requires defining a development process and adhering to it. Below is a core goal for CMMI Level 2 – evaluate adherence to requirements management process.
CMMI Level 2 (Managed) Requirements Management
Achieving this goal requires the ability to decompose requirements across engineering disciplines and maintain traceability up and downstream as the project progresses with significant changes and rework. Without an underlying system architecture and common data model, this goal becomes unattainable for most organizations. Attempts to manage through Word and Excel, become unwieldy and unable to meet the requirements for Live Traceability, leading to defects, delays, cost-overruns, and recalls. Below, you can see how easy it is to manage traceability and view up and downstream multiple levels in a trace view of requirements in Jama Connect. Jama Connect’s Traceability Model defines the data model across best-of-breed tools to capture actual behavior for traceability and management by exception.
To achieve CMMI Level 3 requires defining a development process and adhering to it. Below is a core goal for CMMI Level 3 – establishing a verification process and adhering to it.
CMMI Level 3 (Defined) Verification
Companies are achieving this goal through Jama Connect by establishing a Traceability Model that requires test verification for requirements and managing by exception through dashboard reporting to ensure verification happens across all requirements. Below is a sample verification dashboard to achieve this goal with customer-specific info redacted. Here you can see how the Verification Leader manages their function through exception management. Specific widgets on the dashboard track requirements without tests, failed tests, tests without requirements linked to verify, bugs without tests, and risks without upstream or downstream traceability. The Traceability Model established in Jama Connect defines the expected behavior against which all activity can be compared to generate exceptions that can be managed through the dashboard. Without this system architecture and data model, managing by exception becomes extremely manual and productivity killing, if not impossible.
CMMI Level 4 requires organizations to have developed predictive scores and benchmarks that enable management to identify product development risk early and remediate at much lower cost than if not identified until late in the development process or after product release into the market. The table below shows the definition of this core, Level 4 goal.
CMMI Level 4 (Quantitatively Managed) Process Performance
Leading companies are achieving this goal by applying Jama Software’s Traceability Score™ and benchmarking engineering projects internally and externally against peer companies. Jama Software is the first to measure traceability thanks to our clients’ participation in a benchmarking dataset of over 40,000 complex product development projects spanning aerospace, automotive, consumer electronics, industrial, medical device, semiconductor, space systems, and more. All of this is made possible by our core product, Jama Connect®, which enables the largest community of engineers using requirements management SaaS (Software as a Service) in the world.
To formally measure traceability, we have established the Traceability Score. The Traceability Score measures the level of actual process adherence to the expected traceability model and can be used to compare performance across projects, teams, divisions, and companies. This score can also determine impacts to schedule, budget, cycle times, risk, and quality.
Traceability Score = # of established relationships among model elements as specified by the project’s traceability model.
The following diagram provides an illustration for the buildup of the calculation:
At the individual requirement level, we can identify each expected relationship defined in a project’s traceability model (i.e., user needs defined by requirements, further refined by sub requirements, and test cases that should verify the requirement, etc.). We can then identify how many of these relationships have been established to get an individual requirement’s traceability.
As we go one level higher and measure traceability within a particular element type (e.g., user needs, requirements, tests, etc.) we can sum up the number of expected and established relationships across the set of items, giving us traceability at the element type level.
Finally, we can sum up the number of expected and established relationships across all element types, giving us the project’s total Traceability.
Correlations & Hypothesis Test Results
As a process management tool, the value of a Traceability Score is to quantify actual adherence to the specified approach. To determine best practices from the data, statistical tests were run to understand how differing levels of project adherence to Live Traceability can impact desired outcomes. As we have shown, the Traceability Score measures actual adherence to the defined traceability model. The systems engineering discipline, the V model, quality engineering, and more – all rely on the intuition that this approach will yield better results. Anecdotal evidence abounds to support this intuition, but the dataset has been lacking to conduct statistical tests to test this hypothesis. Using our dataset, we were able to determine that Traceability Scores exhibit statistically significant correlations to the following outcomes and rejected the null hypothesis that these correlations were purely random.
1. Faster time to market
The first three tests focus on how Traceability Scores impact cycle time. Do higher Traceability Scores lead to faster test case execution and defect identification? This is a fundamental value asserted by systems engineering and the V-Model – that earlier detection of defects leads to fewer delays and much lower cost to correct. We measured the following times below and noted performance improvements in top versus bottom performers of 2.1X to 5.3X. Higher Traceability scores were found to lead to faster test case execution and defect detection having passed both of our statistical tests.
Median Time to Execute Test Cases (2.6X faster)
Median Time from Test Start to Defect Detection (5.3X faster)
Median Time to Identify the Set of Defects (2.1X faster)
2. Higher quality
The last three tests focus on how Traceability Scores impact quality. Do higher Traceability Scores lead to a higher quality product? This is a fundamental value asserted by systems engineering and the V-Model – that a commitment to test case creation and execution leads to a higher degree of requirement verification and product quality. We measured the following aspects of testing and verification below and noted performance improvements in top versus bottom performers of 1.9X to 2.9X. Higher Traceability scores, having passed both of our statistical tests, led to more tests being completed and a higher percentage of passed tests.
Percent of Requirements with Verification Coverage (1.9X higher)
Percent of Requirements Verified (2.1X higher)
Initial Test Case Failure Rate (2.4X lower)
Final Test Case Failure Rate (2.9X lower)
Conclusion
The CMMI defines its best practices in terms of goals, practices, and artifacts. The CMMI does not address the underlying systems and data architecture required to enable these practices, deliver these artifacts, and achieve these goals. The systems architecture reality for most engineering organizations is highly fragmented with the necessary data to manage the engineering product and process (user needs, system level requirements, approvals, component level requirements, model designs, component requirement decompositions, interface definitions, test cases, test results, risk analysis, validations, traceability analysis, etc.) spread across hundreds of siloed tools, spreadsheets, emails, and chat tools with high degrees of uncertainty that any information reflects the latest version continually updated with all interdependencies.
As we have shown, it is extremely challenging if not impossible to move up the CMMI maturity model without addressing the underlying systems architecture and data model. Carnegie Mellon has chosen to use our software to train their students and leading companies have deployed Jama Connect in the ways noted above to achieve their CMMI objectives.
This has been part two of a two-part blog series overviewing our recent whitepaper, “How to Achieve Higher Levels of the Capability Maturity Model Integration (CMMI) with Live Traceability™” Click HERE to read the entire thing.
Jama Connect® Features in Five: Medical Device & Life Sciences Solution 2.0 – Part 1
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 the powerful features in Jama Connect®… in under five minutes.
In part one of this two-part Features in Five video series, Jama Software® subject matter expert Vincent Balgos, Director, Medical Device Solutions, will demonstrate the latest solution offerings for Medical Device & Life Sciences in Jama Connect.
We will share part two of this video series here once it’s published.
VIDEO TRANSCRIPT:
Vincent Balgos: Hi. My name is Vincent Balgos, and I’m the Director of Medical Solutions here at Jama Software. In this video, I’m going to talk about our updates to our Medical Device & Life Sciences Solution 2.0. For the agenda, there are quite a few improvements I’d like to share with you today.
So the first thing I want to show is the general organization and layout of our new Medical Device & Life Sciences Solution 2.0. The first thing I want to show is that this new folder that actually has our new Medical Device framework and our other additional popular frameworks such as SaMD and Consumables frameworks. The other folder to mention is really kind of our new use case library that highlights additional use cases that we’ve seen across our three hundred-plus customers and their practices using Jama Connect.
So now let’s go ahead and jump into the tool. We’ve updated the relationship rule diagram with some minor improvements. The first thing we’ve done is really streamline the risk stream where we remove the validation trace and trace this now to an external resource item type. The purpose of this item type is a general documentation catch call for a lot of various traces that you may have.
Balgos: The most common example is associated with risk. Not all risk controls are requirements, so we still need a way to trace to these non-requirement risk controls. These controls may vary depending on your risk management procedures. This provides additional risk coverage traceability that provides flexibility for your organization.
Another thing that we’ve done is actually updated our hazards library to include general hazards identified in ISO 14971. So you have pretty much a starting place with your hazard library The next item that I like to talk about is the risk Lookup Matrix. Available in [Jama Connect] 8.74, this feature allows a new Lookup Matrix risk analysis approach that automatically outputs the desired content based on the preconfigured Lookup table. This really aligns with [ISO] 14971.
Let me show you a quick demo of this. We’ve now implemented this as part of our Medical Device & Life Sciences Solution 2.0. As you can see here on the screen, I have a new item type called Risk Evaluation 2.0 that kind of again follows the general [ISO] 14971 schema of hazard sequence events, hazard situations, harms, but here is now where we’ve implemented this new Lookup Matrix feature. Where now I’ve identified the input pick list where I may be able to change this, and then that automatically updates my risk level based off that matrix.
Balgos: So for example here, if I went ahead and increased this to frequency and I increase my severity from here and this one as well. I can see that both my p total and risk analysis has been updated per the Lookup Matrix. We have an additional Features in Five video that shows cases a little bit more. So we definitely encourage you to look at that further.
The other thing that we wanted to share with particularly this Medical Device update is we have now included preconfigured FMEA item types for ease of implementation for your risk processes. If I go ahead and look into my admin area, when I look at my item type, I’ve now included preconfigured D FMEAs, Process FMEAs and, Use FMEAs that you may configure based on your organization.
Balgos: The intent of this is really to continually improve and provide new solutions to our customers based on customer feedback, industry trends, and best practices.
The industry vertical solution updates expand new use cases and solutions to address complex challenges while continuing to comply with industry regulations. Please contact your Jama Connect success manager or consultant to learn how to implement these new solutions at your organization.
In part one of this two-part blog series, we provide an overview of our recent whitepaper, “How to Achieve Higher Levels of the Capability Maturity Model Integration (CMMI) with Live Traceability™” Click HERE to read the entire thing.
How to Achieve Higher Levels of the Capability Maturity Model Integration (CMMI): Part 1
The Capability Maturity Model Integration (CMMI), developed at Carnegie Mellon University’s Software Engineering Institute, is a recognized standard for engineering best practices that reduce the risk of defects, delays, cost overruns, and recalls. Organizations that choose to adopt CMMI strive to progress up the five levels in the maturity model by implementing sequentially more advanced best practices spanning the engineering development process.
Jama Software® is honored to be chosen by Carnegie Mellon as the primary tool used to in its Master of Science in Software Engineering to train the next generation of software engineering leaders in best practices for requirements management, reviews, verification, validation, and process performance management.
The CMMI defines its best practices in terms of goals, practices, and artifacts. The CMMI does not address the underlying systems and data architecture required to enable these practices, deliver these artifacts, and achieve these goals. The systems architecture reality for most engineering organizations is highly fragmented with the necessary data to manage the engineering product and process (user needs, system level requirements, approvals, component level requirements, model designs, component requirement decompositions, interface definitions, test cases, test results, risk analysis, validations, traceability analysis, etc.) spread across hundreds of siloed tools, spreadsheets, emails, and chat tools with high degrees of uncertainty that any information reflects the latest version continually updated with all interdependencies.
The main reason for this landscape of siloed tools is that each engineering discipline is empowered to choose a best-of-breed tool to optimize engineer productivity within their team. The breadth of functionality covered in total by all of these tools — spanning all engineering disciplines — precludes the potential for a single software vendor to provide one software tool which could replace all these best-of-breed tools to the satisfaction of every engineer across disciplines. Generally speaking, each engineering field uses their chosen best-in-class technology to accomplish their objectives. That said, the data needed to achieve CMMI goals, practices, and artifacts is unstructured, unrelated, unconnected, and unmeasurable, which poses a serious challenge when it comes to achieving goals, practices, and artifacts that must span multiple disciplines to control, manage, and improve the engineering process. In order to advance along the maturity model, each engineering organization (regardless of size) needs a unified data model architecture and automated synchronization spanning best-of-breed tools. Without these improvements, most engineering organizations struggle to achieve Level 2 (Managed) and can only do so in a highly manual, after-the-fact manner that generally fails to deliver the desired outcome benefits.
Let’s take a look at a few specific examples from CMMI to demonstrate the need for a unifying data model and an overview of how to achieve it. The first one we will examine is a core practice from the Requirements Management section for Level 2 (Managed) that specifies bidirectional traceability from high level requirements through decomposed requirements and work products across engineering disciplines to generate and maintain a traceability matrix.
There are two ways companies can approach achieving this traceability practice: after-the-fact traceability or Live Traceability™.
After-the-fact traceability occurs after the product has been developed and is typically a highly manual effort to try and re-create artifacts to demonstrate traceability that should have occurred during the development process but did not. This effort is undertaken solely to comply with industry standards and satisfy auditor requests for demonstration of process maturity.
Live Traceability occurs in real time as the product development process progresses to improve overall productivity (by ensuring engineers across disciplines are always working off the most recent and correct versions) and to reduce the risk of negative product outcomes (delays, defects, rework, cost overruns, recalls, etc.) through early detection of issues. The benefits of early detection of issues are significant. Research by INCOSE found that issues not found until verification and validation are 40 to 110 times more costly than if found during design. For this reason, most companies want Live Traceability but are stuck with legacy tools and spreadsheets that do not support it. Since each engineering discipline is allowed to choose its own tooling, the result is a large number of tools with no relationship rules or mechanisms to create Live Traceability across them.
So how do you achieve Live Traceability?
STEP 1: Define a Traceability Model
Live Traceability requires a model of the key process elements and their relationship rules to monitor during the development process. Below you see a sample relationship rule diagram from Jama Connect® that defines a common data model that spans best-of-breed tools which enables engineering organizations to manage traceability in real-time and improve process performance. Relationship rules vary by industry and company-specific requirements. Best practice templates are provided to comply with industry standards and configured to meet client-specific needs. The definition of a traceability model forms the foundation for model-based systems engineering (MBSE) since it defines model elements and their relationship to each other in a consistent manner across the entire system architecture.
Step 2: Setup Continuous Sync for Siloed Tools/Spreadsheets
Once the relationship rules are defined, the next step is to set up continuous sync with best-of-breed tools and spreadsheets used by the various engineering disciplines. The traceability diagram below shows a typical example of best-of-breed tools and where they sync in the Jama Connect relationship model to deliver Live Traceability.
Most companies prioritize the areas of the traceability model that are most prone to lead to costly issues in the absence of a continuous sync. Most commonly, these areas are:
Software task management – directly linking the decomposition of requirements into user stories enables Live Traceability through the software development process through testing and defect management.
Test automation – test cases are managed in Jama Connect to align to requirements and ensure traceability across all engineering disciplines with the test automation results sync’d to the traceability model at the verification step.
Risk analysis (DFMEA/FMEA) – is most often conducted in multiple Microsoft Excel spreadsheets and the assumption has been that Live Traceability was not possible with Excel. Jama Connect is the first requirements management solution to enable Live Traceability with Excel functions and spreadsheets. Risk teams can now work in their preferred spreadsheets AND for the first time achieve live traceability to stay in sync with changes made by any engineering team.
Model-based systems engineering (MBSE) – the first step in MBSE is to define a relationship model between all product requirements. Once a relationship model is defined, then specifications can be determined through modeling. Jama Connect uniquely provides model-based requirements to sync logically with a SysML modeling tool like Cameo No Magic.
Live Traceability provides the ability, for the first time, to manage by exception the end-to-end product development process across all engineering disciplines. The traceability model defines expected process behavior that can be compared to actual activity to generate exceptions. These exceptions are the early warning indicators of issues that most often lead to delays, cost overruns, rework, defects, and recalls. Below is a sample exception management dashboard in Jama Connect.
This has been part one of a two-part blog series overviewing our recent whitepaper, “How to Achieve Higher Levels of the Capability Maturity Model Integration (CMMI) with Live Traceability™” Stay tuned for part two and click HERE to read the entire thing.
Curious to learn how the Medical Device Framework in Jama Connect® can help streamline your compliance efforts and ensure your products meet necessary regulatory requirements?
During this informative session, Vincent Balgos, Director of Medical Device Solutions at Jama Software® discusses the latest solution offerings for Medical Device and Life Sciences in Jama Connect, including:
Updated Software as Medical Device (SaMD) framework incorporating readily available off-the-shelf elements for workflow and efficiency
Newly developed Research Use Only (RUO) and In-Vitro Diagnostics (IVD) frameworks
Refined solution enhancements, including new and updated report templates
Self-guided onboarding framework to assist new users in Jama Connect
Discover how Jama Connect can help you optimize compliance and regulatory processes, helping you stay ahead in the constantly evolving medical device industry.
Below is an abbreviated transcript and a recording of our webinar.
Elevating Your Medical Device and Life Sciences Product Development Processes with Jama Connect®
Vincent Balgos: For today’s webinar, I’d like to talk about our updates to our Medical Device and Life Sciences Solution 2.0. For the agenda, there are quite a few improvements I’d like to share with you today. The first one is really just kind of talking about general overview and general improvements in terms of risk, some new features that we’ve enabled with Jama Connect, but also some new and updated solutions such as Software as a Medical Device, Research Use Only, and our new self-guided onboarding framework.
So the intent of the update is to continually improve Jama solution to the medical device and life sciences industries based on a variety of factors, including new Jama Connect features and abilities that help streamline general product development processes and industry best practices. Also adapts to the ever-evolving regulations such as MDR, IVDR, and potential changes to the lab developed test area. We’ll talk about more of this in the ROU space. We’ve also included internal research and internal experience with over 80 years of industry experience from the internal Jama team. And lastly, we’ve also incorporated some feedback from customers like yourselves on best practices, innovative solutions, and new use cases. So thank you ahead of time and please continue to contribute via the Jama Community Ideation page or discussion with Jama folks.
These solutions that are presented are compatible and available with Jama Connect for both our cloud customers, both the standard and validated, and our self-hosted environments. Some highlighted features may require version updates, and this is really particular to our self-hosted customers with legacy versions.
Balgos: So what I’d like to first talk about is the general organization and layout. So what I’m going to do is come back between screens, between the PowerPoint and the actual, the demo itself.
So the first thing I want to show is the general organization and layout of our new Medical Device Framework 2.0. The first thing I want to show is when we go ahead and take a look, you’ll see here in this new folder we have something enumerated Medical Device Framework 2.0, that actually has our new Medical Device Framework and our other additional popular framework such as SAMD and Consumables Framework.
The other folder to mention is really kind of our new use case library that highlights additional use cases that we’ve seen across our 300 plus customers and their practices using Jama Connect. We’ll deep dive into each one of these very shortly. We’ve also archived the current… sorry, the previous Medical Device Framework 1.0 for your reference only.
So now let’s go ahead and dive into the overview of the MDF 2.0. So I’m going to jump into the tool. And as you can see here right on the screen, we’ve updated the relationship rule diagram with some minor improvements. The first thing we’ve done is really streamline the risk stream where we remove the validation trace and trace this now to an external resource item type. The purpose of this item type is a general documentation catch call for a lot of various traces that you may have. The most common example is associated with risk. So as many of you may know, not all risk controls are requirements. So we still need a way to trace to these non-requirement risk controls. These controls could be IFUs or instructions for use, training, labeling, or labeling and packaging, et cetera, and may vary depending on your risk management procedures. This provides additional risk coverage traceability that provides flexibility for your organization.
Balgos: Another thing that we’ve done is actually updated our hazards library to include general hazards identified in 14971. As you can see here on the screen, we’ve now populated the general hazards identified in 14971 based on the information that you have. So you have pretty much a starting place with your hazard library that you have here.
The next item that I’d like to talk about is actually this new feature called the Risk Lookup Matrix. Available in 8.754, this features allows a new lookup matrix risk analysis approach that automatically outputs the desired content based on a pre-configured lookup table. This really aligns with 14971. Let me show you a quick demo of this because we’ve now implemented this as part of our Medical Device Framework 2.0.
Balgos: As you can see here on the screen, I have a new item type called Risk Evaluation 2.0 that kind of, again, follows the general 14971 schema of hazardous sequence of events, hazardous situations harmed. But here is now where we’ve implemented this new lookup matrix feature where now I’ve now identified the input pick lists where I may be able to change this, and then that automatically updates my risk level based off that matrix. So for example here, if I went ahead and increases the frequency and I increase my severity from here over here, and this one as well, I can see that both my P total and risk analysis has been updated per the lookup matrix. We have an additional features [inaudible 00:07:27] video that showcases a little bit more. So we definitely encourage you to look at that further.
The other thing that we wanted to share with particularly this medical device update is we have now included pre-configured FMEA item types for ease of implementation for your risk processes. If I go ahead and look into my admin area, what I mean by this is when I look at my item type, I’ve now included pre-configured DFMEAs, process FMEAs, and use FMEAs that you may configure based on your organization. This just allows for streamlining of your risk measures processing quickly to Jama Connect.
Alongside the honor of being named the only leader in requirements management software, we are proud to showcase that we were awarded several additional medals for Summer 2023 in both Requirements Management Software and Application Lifecycle Management (ALM) Software, including:
Users Love Us: For products that have collected 20 reviews with an average rating of 4.0 stars.
Enterprise Leader: For products rated highly by G2 users and have substantial Satisfaction and Market Presence scores
Momentum Leader: Products in the Leader tier in the Momentum Grid® rank in the top 25% of their category’s products by their users.
Easiest to Use: The product in the Usability Index earned the highest Ease of Admin rating in its category
Best Relationship: The Best Relationship product in the Relationship Index earned the highest Relationship rating in its category
Easiest To Do Business With: The Easiest Doing Business With product in the Relationship Index earned the highest Ease of Doing Business With rating in its category
Easiest Admin: For products that earn the highest Ease of Admin rating in their category
Best Usability: The Best Usability product in the Usability Index earned the highest Usability rating in its category
Fastest Implementation: For product that had the shortest go-live time in its category
Easiest Setup: The product that earned the highest Ease of Setup rating in its category
Users Most Likely to Recommend: The Users Most Likely to Recommend product in the Results Index earned the highest Likely to Recommend rating in its category
Download the full report to see why customers love using Jama Connect for product, systems, and software development.
Learn More About the Summer 2023 G2 Grid for the top Requirements Management Software productsHERE!
At Jama Software®, we’re proud to be recognized as the leader in requirements management software. We’re grateful to our customers for their invaluable feedback on their experiences using Jama Connect for requirements management. We remain committed to providing them with the expert knowledge, attention, and resources they need to help them achieve their goals.
The “Users Love Us” category, in particular, is a testament to the value our industry-leading requirements management software brings to our customers, and especially for customers who have moved from a document-based approach to complex product, systems, or software developement.
“Jama [Connect] is the final death blow to your grandfathers way of managing text based requirements.”
-From review collected and hosted on G2.com, Mark M. — Mid-Market
We strive to provide our customers with the best experience while using our platform. Categories such as “Easiest to Use”, “Easiest Admin”, “Users Most Likely to Recommend”, and “Best Usability” in particular show how much our users enjoy working within Jama Connect.
“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.”
-From review collected and hosted on G2.com, Verified User, Retail — Mid-Market
From all of us at Jama Software to all of you, thank you!
G2 scores products and sellers based on reviews, gathered from their user community, as well as data aggregated from online sources and social networks. Together, these scores are mapped on their proprietary G2 Grid®, which can be used to compare products, streamline the buying process, and quickly identify the best products based on the experiences of your peers.
Traceability Matrix 101: Why It’s Not the Ultimate Solution for Managing Requirements
In this post, we cover the definition of a traceability matrix and discuss the limitations of using a trace matrix for requirements management and provide an alternate, superior option.
Trace matrices, also known as traceability matrices, are frequently used in complex product, system, and software development to keep track of the connections between specifications, design components, and test cases. They provide an organized way to make sure that the system’s planning, execution, and testing satisfy each requirement. When utilizing trace matrices in challenging development projects, however, it is important to consider a number of their known drawbacks.
Here are five key limitations of using a traditional traceability matrix for requirements management:
1. Limited Visibility: In projects with a lot of requirements and design components, trace matrices can grow significantly in size and complexity. As a result, it can be difficult for teams and stakeholders to get a comprehensive understanding of the complete system — and to understand how each requirement relates to the other components. This often results in mistakes and gaps in the trace matrix, which lowers the system’s quality and introduces risk to both the project and the product.
2. Maintenance Overhead: Trace matrices require constant maintenance throughout the development process. As new requirements are added or changed, the trace matrix needs to be updated to reflect these changes. This can be time-consuming and can take away from other important development tasks. Additionally, it can be challenging to keep track of every change, which can result in mistakes in the trace matrix.
3. Limited Scope: Trace matrices are typically limited to the scope of the specific project they were designed for. They are insufficient for tracing issues that span across various disciplines, such as security or efficiency, which may require a different, more robust, traceability strategy. Additionally, trace matrices might not fully account for a system’s complexity, such as sudden changes or relationships between components, which can result in unforeseen issues.
4. Lack of Context: Trace matrices only provide a static view of the system and do not capture the dynamic context in which the system operates. For example, a requirement may be met by a design element, but the design element may have unintended consequences when combined with other elements in the system. Trace matrices may not capture these interactions, which can lead to bugs or other issues in the final system.
5. Limited Support for Agile Development: Trace matrices are typically associated with traditional, waterfall-style development processes, which do not align well with Agile development methodologies. Agile development processes emphasize collaboration, iterative development, and quick feedback cycles, which can be difficult to reconcile with the strict traceability requirements of a trace matrix. As a result, trace matrices may not be well-suited for Agile development projects.
Five Advantages of Using a Robust Requirements Management and Traceability Solution, Like Jama Connect®, Over a Static Traceability Matrix
Jama Connect®’s powerful, yet easy-to-use, requirements management and traceability platform bring people and data together in one place, providing visibility and actionable insight into the complete product development lifecycle. Teams and stakeholders — regardless of their location — can easily share updates in seconds, discover issues weeks sooner, and have one place to collaborate with key stakeholders — in real time. As a result, Jama Connect offers many advantages over using a traditional traceability matrix.
Here are five advantages of Jama Connect:
1. Automation: Jama Connect automates many tasks that would be tedious and time-consuming to do manually. For example, it can automatically generate traceability matrices, link requirements to test cases, and track changes to requirements. And, because testing is built into Jama Connect, users can take advantage of our trace view to navigate from high level requirements, all the way down to test cases and defects. This allows users to view any failed tests or open defects that are associated with their upstream requirements. Because traditional trace matrices are static, they are unable to benefit from this type of automation.
2. Visibility: Jama Connect provides a more comprehensive view of the requirements and their relationships than a static traceability matrix by automatically generating Live Traceability™ which allows you to navigate levels of traceability both upstream AND downstream. With Jama Connect, you can see the entire requirements hierarchy, including parent-child relationships, dependencies, and impact analysis.
3. Collaboration: Jama Connect makes it easy for teams to collaborate on requirements. With features like comments, reviews, and notifications, team members and stakeholders can discuss and iterate on requirements in real-time.
4: Customization: Jama Connect is highly customizable, allowing it to be tailored to your specific needs. You can create custom fields, workflows, and reports to match your organization’s processes and requirements.
5. Scalability: Jama Connect is designed to handle large and complex projects with thousands of requirements. It can support multiple teams, projects, and stakeholders, and can integrate with other best-of-breed tools in your ecosystem.
Additionally, with Jama Connect, teams can implement live requirements traceability and measure it to continuously improve end-to-end systems development process performance, even through siloed development, test, and risk activities.
Live requirements traceability is the ability for any engineer at any time to see the most up to date and complete upstream and downstream information for any requirement—no matter the stage of systems development or how many siloed tools and teams it spans. This enables the engineering process to be managed through data, and its performance improved in real time.
Conclusion
Even though trace matrices can be a helpful tool for keeping track of requirements, design components, and test cases in some development projects, there are several drawbacks to be cognizant of, especially as projects become increasingly complex. These limitations include limited visibility, lack of context, narrow scope, maintenance overhead, and inadequate support for Agile development. So, it might be time to consider other, more modern, and robust approaches to traceability for complex product, systems, and software development projects.
Jama Connect, the leading requirements management and proven traceability software platform, enables a digital thread that ties tools and metadata together across the end-to-end product lifecycle. This provides real-time insights that allow for streamlined product development that is less prone to overall risk, rework, or recalls. Overall, Jama Connect offers more automation, visibility, collaboration, customization, and scalability than a traditional traceability matrix — and provides a more modern and efficient way of managing requirements in complex product, system, and software development.
Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Karrie Sundbom and Mario Maldari.
![[Webinar Recap] Effectively Managing Cybersecurity in Jama Connect® for Automotive and Semiconductor Industries](https://www.jamasoftware.com/media/2023/07/2023-Webinar-Recap-Med-Update-1.png "[Webinar Recap] Effectively Managing Cybersecurity in Jama Connect® for Automotive and Semiconductor Industries")
In part two of this two-part blog series, we continue the overview of our recent whitepaper, “How to Achieve Higher Levels of the Capability Maturity Model Integration (CMMI) with Live Traceability™” Click 
In part one of this two-part blog series, we provide an overview of our recent whitepaper, “How to Achieve Higher Levels of the Capability Maturity Model Integration (CMMI) with Live Traceability™” Click 
![[Webinar Recap] Elevating Your Medical Device and Life Sciences Product Development Processes with Jama Connect®](https://www.jamasoftware.com/media/2023/07/2023-Webinar-Recap-Med-Update.png "[Webinar Recap] Elevating Your Medical Device and Life Sciences Product Development Processes with Jama Connect®")
