Tag Archive for: systems thinking

Tag Archive for: systems thinking

Product development

Close gaps in product development with Jama Connect™ and LDRA

Interested in closing gaps in your product development lifecycle? It’s no secret that developers of mission-critical software are facing increasingly complex system requirements and stringent standards for safety and efficacy. That’s why Jama Software has partnered with LDRA to deliver a test validation and verification solution for safety- and security-critical embedded software. LDRA has been a market leader in verification and software quality tools for over 40 years. They serve customers across the aerospace and defense, industrial energy, automotive, rail, and medical device industries.

Integrating TÜV SÜD-certified Jama Connect with the LDRA tool suite gives teams bidirectional traceability across the development lifecycle. This transparency helps development teams build higher-quality products and get to market faster while mitigating risk. Whether teams are working from a standards-based V model or applying an Agile, Spiral, or Waterfall methodology, employing Jama Connect in concert with the TÜV SÜD- and TÜV SAAR-certified LDRA tool suite closes the verification gaps in the development lifecycle, helping to ensure the delivery of safe and secure software.

Let’s dive into some details to understand the value of using Jama Connect and the LDRA tool suite.

Requirements and test cases form the bond between Jama Connect™ and LDRA

Product managers and engineers use Jama Connect to manage requirements and testing from idea through development, integration, and launch. Managing requirements in the Jama Connect platform allows users to align teams, track decisions, and move forward with confidence that they are building the product or system they set out to build.

LDRA imports Jama requirements and test cases, mirroring the structure and levels of traceability established from the decomposition of stakeholder requirements down to software requirements and test cases. With the Jama artifacts in the LDRA tool suite, traceability down to the code can be realized and verification and validation of requirements can begin.

During the Jama test case import, the user can choose the type of test case it corresponds to (e.g. unit test, system test, code review test) and let LDRA create a test artifact that will invoke the proper part of the LDRA tool suite and realize that test case type.

Part of realizing Jama test cases in the LDRA tool suite includes the ability to follow the steps defined in the Jama test case description (e.g. inputs, outputs, expected results). Test cases executed by the LDRA tool suite can be executed either on a host machine, in a virtual environment, or on the actual target hardware. Verification results are captured, and Pass/Fail status results are produced. The verification results can then be exported from the LDRA tool suite into the Jama test case verification status field.

By way of the Jama Test Run feature, the change in verification status and included user notes can be logged and committed. Additionally, if the user desires, the LDRA tool suite verification results can also be exported into the Jama requirement verification status field, giving the Jama user additional touch points to analyze.

Another benefit of the integration is Jama’s ability to create, link, assign, track, and manage defects discovered during testing with the LDRA tool suite.

Partnering with standards and safety experts on product development

Many industries and their applications have safety-critical requirements drawn from process standards like ISO 14971 and ISO 26262. These requirements demand a higher level of visibility and traceability that can be achieved with the Jama-LDRA integration.

LDRA is heavily involved in the international standards body. They help lead the DO-178 standard in the aerospace market for safety in avionics. LDRA is also a significant contributor to the MISRA software coding standard and other standards like CERT. Their tool suite is ISO 9001:2008-certified as a quality management system and TÜV SÜD- and TÜV SAAR-certified.

The Jama-LDRA partnership benefits not only LDRA customers in the military and aerospace needing to comply with standards like DO-178B/C, but also one of the fastest-growing industries, and the one that keeps LDRA the busiest: the automotive industry and their need to comply with ISO 26262. The Jama-LDRA partnership also addresses applications for safety and security in the medical device industry (IEC 62304), rail (EN 50128), and industrial controls and energy (IEC 61508).

RELATED: Increasing Efficiency in Testing and Confidence in Safety Standard Compliance

Certification and code analysis

LDRA helps users achieve certification in standards like DO-178B/C, DO-331, ISO 26262, Future Airborne Capability Environment (FACE), IEC 61508, and others. The LDRA tool suite lays out a set of objectives for the relevant process standard, along with corresponding artifact placeholders and sample template documents. This guiding project structure with built-in progress metrics gives the user an intuitive understanding of what is required to achieve certification and the day-to-day gains toward that goal.

A major key benefit to customers is LDRA’s ability to perform on target hardware testing or Run-For-Score (RFS). These customers have a very strict process for achieving certification wherein step-by-step testing is followed and results are logged and eye-witnessed.

LDRA also has its own proprietary code analysis engine. Starting with static code analysis, a debugging method that examines the source code before the program is run, LDRA generally finds potential coding flaws and security vulnerabilities prior to code compilation. Once the code has been compiled, testing can be further complemented by LDRA’s dynamic testing, structural coverage, and unit testing.

Build with certainty

The complementary capabilities and automation offered by Jama and LDRA deliver a powerful solution for the development and test verification of software systems in the product development lifecycle. Whatever software development approach your team chooses to employ, requirements- combined with Jama’s product lifecycle management capacities can help you deliver safe, compliant products on time and on budget.

To learn more about test management with Jama, take a deeper look at our solution and download the datasheet.

To learn more on the topic of test management, we’ve compiled a handy list of valuable resources for you!

Systems thinking is an approach to solving complex problems by breaking their complexity down into manageable units. This makes it easier to evaluate the system holistically as well as in terms of its individual components.

A high-level, interconnected view of the product development process can yield new insights into how products are defined, built, released and maintained. Product managers sit at the center of the product development system, so they’re primarily responsible for understanding and directing the system.

You can think of systems thinking as a diagnostic tool: a disciplined approach to examining problems more completely and accurately before taking action. Systems thinking encourages teams to ask the right questions before charging ahead under the assumption that they already know the answers.

For product teams grappling with exceptionally complex design specs and requirements, systems thinking opens the door to procedure-level improvements and the ability to take full advantage of solutions that support them.

In this post, following up on our recent piece about systems thinking for medical device development, we talk about how product managers can leverage systems thinking to improve their processes.

The Iceberg Model: How to Put Systems Thinking Into Action

The Iceberg Model is a practical way to put systems thinking into action. We borrowed the following excellent example from the smart folks at the Northwest Earth Institute.

Picture an iceberg (doomed ship optional). The tip sticking out of the water represents the event level. Problems detected at the event level are often simple fixes: You wake up in the morning with a cold, so you take a couple of ibuprofen to feel better. However, the Iceberg Model encourages us not to assume that every issue at the event level can be quickly resolved by treating the symptom.

Just below the event level is the pattern level. As the name suggests, this is where you detect patterns: You catch more colds when you skimp on sleep. Observing patterns helps product managers forecast events and identify roadblocks before they rear their ugly heads.

Below the pattern level is the structure level. If you ask, “What’s causing this pattern?” the answer is likely to be structural. You catch more colds when you skimp on sleep, and you skimp on sleep when you’re under pressure at work or when your personal life is causing you stress.

The mental model level is where you find the attitudes, beliefs, expectations and values that allow structures to function as they do. These attitudes are often learned subconsciously: from our parents, our peers, our society. If “I’ll sleep when I’m dead” is part of your mental model, you’ll have trouble making the attitude and behavior adjustments that could help you avoid another cold.

The Iceberg Model encourages you to stop putting out fires and start addressing deeper issues. Using this model can align your team members through shared thinking and reveal opportunities to make small changes to the process that will yield big benefits.

More Visibility, Superior Collaboration

With a systems-thinking approach, complex product development teams can improve their processes by enhancing visibility and enabling more seamless collaboration and coordination between stakeholders.

Complex product development requires that the right people have visibility into the right parts of the system at the right time. Systems thinking drives teams to coordinate and communicate through a common system need. Collaboration becomes easier and more productive when teams are free to find approaches within their disciplines that are most effective for them, while still meeting the needs of the system.

Compliance & Traceability

Simple changes to requirements can have far-reaching impacts, and it’s hard to isolate every system component that could be affected by a requirement modification. It’s easier to assess the impact of proposed changes – that is, to perform valuable impact analysis – when you have a roadmap that shows you precisely where each requirement or business rule was implemented in the software. Traceability gives you that roadmap.

By helping identify all the areas you may have to modify to implement a proposed change to a requirement, traceability enables impact analysis. With proper traceability, you can follow the life of a requirement both forward and backward, from origin through to implementation.

Traceability is difficult to establish after the fact, so teams can use a tool like Jama Connect from the beginning to track tasks, keep tabs on evolving requirements and contextualize test results. Traceability gives teams confidence in the safety and quality of their products, and helps them demonstrate compliance with national and international standards for highly regulated industries.

Since lower-level requirements and outputs are defined within the context of a specific system need, traceability allows teams to understand that context and the downstream impacts of any change made.

Customized Solutions for Complex Product Development

Organizations across a huge range of industries are engaged in complex product development. Systems thinking encourages teams to work through a common system need, while still employing the approaches that work best within their disciplines. To assist, Jama Connect provides visibility throughout the product development cycle and keeps stakeholders connected to minimize miscommunication and unnecessary rework.

And our Jama Professional Services consultants work with you to understand your objectives and configure the platform to support your process in the optimal way. As your process, people and data change, our experts help you realign development methodologies to best practices, elevate your requirements management skills and reinforce your process. For larger teams that want ongoing deployment and optimization assistance, our adoption services give you a team of experts at your fingertips.

Learn more about some of the ways systems thinking helps overcome complex product development with our whitepaper, “Systems Engineering and Development.”

 

Systems thinking is an approach to solving complex problems by breaking their complexity down into manageable units so the system can be evaluated holistically and by each constituent part. This approach is critical to how we align Jama Connect™ to tackle the daunting complexity of medical device development.  

In our experience working with some of the market’s foremost medical innovators, we’ve seen that teams who embrace systems thinking are better-positioned to modernize and improve their product development processes. Jama Connect is informed by systems thinking and regulatory requirements, while its framework remains flexible enough to accommodate the unique needs of diverse development teams.

In this post, we’ll lay out how and why complex medical device development teams should be using systems thinking to streamline and strengthen processes, according to a recent webinar.  

Why Systems Thinking? 

Complex medical device development teams use systems thinking as a diagnostic tool: a disciplined approach to examining problems more completely and accurately before taking action. Systems thinking encourages teams to ask the right questions before assuming they know the answers.

A systems thinking approach opens up your team and organization to procedure-level improvements and the ability to take full advantage of solutions that support them. 

Even manufacturers developing complex systems that involve multiple disciplines and require the management of numerous subsystems may not be realizing the full value of systems thinking for managing design, collaboration and traceability across teams.  

Visibility and Collaboration 

With a systems thinking approach, teams developing complex medical devices can improve their processes by enhancing visibility and enabling more seamless collaboration and coordination between stakeholders.  

Complex medical device development requires that the right people have visibility into the relevant parts of the system, and a systems-thinking approach helps ensure that the right questions are being asked and addressed. 

Systems thinking also drives teams to coordinate and communicate through a common system need. Collaboration becomes easier and more effective when teams are free to find approaches within their disciplines that are most effective for them, while still meeting the needs of the system.  

Design History File, Verification and Traceability 

Systems thinking also gives teams better tools for managing complexity and change during the design process. With an applied systems approach, organizations can realize and resolve inefficiencies in their product development processes while producing the necessary outputs for the design history file (DHF). Jama Connect, designed to support systems thinking, aligns how your team works with the artifacts required for compliance and the DHF. 

If you’re following ISO 13485 and the FDA regulations for design control, for instance, you’re already driving toward a general systems approach. The regulations require the definition of user and patient needs and the tracing of engineering responses to those needs as design inputs. However, the regulations rightly leave room for manufacturers to define their own procedures, so long as the outcome demonstrates the relationship between the needs, the subsequent design inputs and the resulting design outputs and verifications.  

Applying a systems approach to how you work means that the value of understanding the interrelatedness of the design requirements doesn’t just live in the trace matrix document. This value is realized when you can visualize and interact with the trace during your design definition activities and beyond. The trace must be maintained throughout the design process to be helpful. Thus, the matrix you need for your DHF becomes a byproduct of how you work, not something you stitched together at the end of the design stage when you needed that documentation.  

The same can be said for your design input files and other artifacts: They’re most valuable when they are considered as byproducts of how you work.  

Additionally, verification and quality teams can leverage systems thinking to assess and define verification activities for the system even as other teams explore their responses to the system needs. 

Since lower-level requirements and outputs are defined within the context of a specific system need, traceability allows teams to understand that context and the downstream impacts of any change made.  

Customized Solutions for Medical Device Developers 

Our professional services team has also established a recommended framework for Jama Connect via our Medical Device Services. This framework, informed by systems thinking, guides regulatory compliance while remaining flexible enough to accommodate the diverse needs of teams and organizations.  

In this framework, the need for documentation informs rather than constrains, and it isn’t at odds with your drive to improve your process or the solutions you deploy to realize those improvements.  

Stay tuned for more posts about improving medical device development and the integral role Jama Software is playing for its customers.