Tag Archive for: traceability

A Nod To MOSA: Deeper Documenting of Architectures May Have Prevented Proposal Loss

A Nod To MOSA: Deeper Documenting of Architectures May Have Prevented Proposal Loss

Lockheed loses contract award protest in part due to insufficient Modular Open Systems Approach (MOSA) documentation.

On April 6th the GAO handed down a denial to Sikorsky-Boeing proposal protest of the Army tiltrotor award to Textron Bell team. This program is called the Future Long Range Assault Aircraft (FLRAA) which is supposed to be a replacement for the Blackhawk helicopter. In reading the Decision from the GAO, it is apparent that there was a high degree of importance placed on using a Modular Open Systems Approach (MOSA) as an architecture technique for the design and development. For example, the protest adjudication decision reveals, “…[o]ne of the methods used to ensure the offeror’s proposed approach to the Future Long-Range Assault Aircraft (FLRAA) weapon system meets the Army’s MOSA objectives was to evaluate the offeror’s functional architecture.” Sikorsky failed to “allocate system functions to functional areas of the system” in enough detail as recommended by the MOSA standard down to the subsystem level which is why they were given an Unacceptable in the engineering part of their proposal response.

MOSA will enable aerospace products and systems providers to not only demonstrate conformance to MOSA standards for their products but allow them to deliver additional MOSA-conformant products and variants more rapidly. By designing for open standards from the start, organizations can create best-in-class solutions while allowing the acquirer to enable cost savings and avoidance through reuse of technology, modules, or elements from any supplier via the acquisition lifecycle.

Examining MOSA

What is a Modular Open Systems Approach (MOSA)?

A Modular Open Systems Approach (MOSA) is a business and technical framework that is used to develop and acquire complex systems. MOSA emphasizes the use of modules that are designed to work together to create a system that is interoperable, flexible, and upgradeable. To do this MOSA’s key focus is designing modular interface commonality with the intent to reduce costs and enhance sustainability efforts.

More specifically, according to the National Defense Industrial Association (NDIA), “MOSA is seen as a technical design and business strategy used to apply open system concepts to the maximum extent possible, enabling incremental development, enhanced competition, innovation, and interoperability.”

Further, on January 7, 2019, the U.S. Department of Defense (DoD) issued a memo, signed by the Secretaries of the Army, Air Force, and Navy, mandating the use of the Modular Open Systems Approach (MOSA). The memo states that “MOSA supporting standards should be included in all requirements, programming and development activities for future weapon system modifications and new start development programs to the maximum extent possible.”

In fact, this mandate for MOSA is even codified into a United States law (Title 10 U.S.C. 2446a.(b), Sec 805) that states all major defense acquisition programs (MDAP) are to be designed and developed using a MOSA open architecture.

MOSA has become increasingly important to the DoD where complex systems such as weapons platforms and communication systems require a high level of interoperability and flexibility. Their main objective is to ensure systems are designed with highly cohesive, loosely coupled, and severable modules that can be competed separately and acquired from independent vendors. This allows the DoD to acquire systems, subsystems, and capabilities with increased level of flexibility of competition over previous proprietary programs. However, MOSA can also be applied to other industries, such as healthcare and transportation, where interoperability and flexibility are also important considerations.

The basic idea behind MOSA is to define architectures that are composed of more, more manageable modules that can be developed, tested, and integrated independently. Each module is designed to operate within a standard interface, allowing it to work with other modules and be easily replaced or upgraded.

RELATED: Streamlining Defense Contract Bid Document Deliverables with Jama Connect®

The DOD requires the following to be met to satisfy a MOSA architecture:

  • Characterize the modularity of every weapons system — this means identifying, defining, and documenting system models and architectures so suppliers will know where to integrate their modules.
  • Define software interfaces between systems and modules.
  • Deliver the interfaces and associated documentation to a government repository.

And, according to the National Defense Authorization Act for Fiscal Year 2021, “the 2021 NDAA and forthcoming guidance will require program officers to identify, define, and document every model, require interfaces for systems and the components they use, and deliver these modular system interfaces and associated documentation to a specific repository.”

  • Modularize the system
  • Specify what each component does and how it communicates
  • Create interfaces for each system and component
  • Document and share interface information with suppliers

MOSA implies the use of open standards and architectures, which are publicly available and can be used by anyone. This helps to reduce costs, increase competition, and encourage innovation.

Why is MOSA important to complex systems development?

MOSA, an important element of the national defense strategy, is important for complex systems development because it provides a framework for developing systems that are modular, interoperable, and upgradeable. Here are some reasons why MOSA is important:

  • Interoperability: MOSA allows different components of a system to work together seamlessly, even if they are developed by different vendors or organizations. This means that the system can be upgraded or enhanced without having to replace the entire system.
  • Flexibility: MOSA promotes the use of open standards and architectures, which allows for greater flexibility in system development. It also allows for more competition among vendors, which can lead to lower costs and better innovation.
  • Cost-effectiveness: MOSA can reduce costs by allowing organizations to reuse existing components or develop new components that can be integrated into existing systems. It can also reduce the cost of maintenance and upgrades over the lifecycle of the system.
  • Futureproofing: MOSA allows for systems to be upgraded or modified over time, as new technology becomes available. This helps to future-proof the system, ensuring that it can adapt to changing needs and requirements.

RELATED: Digital Engineering Between Government and Contractors

How can Live Traceability™ in Jama Connect® help with a MOSA?

Live Traceability™ in Jama Connect® can help with MOSA by providing mechanisms to establish traces between MOSA architecture elements and interfaces, and the requirements and verification & validation data that support them. Live Traceability is the ability to track and record changes to data elements and their relationships in real-time. This information can be used to improve documenting system design, identify potential issues, and track changes over time.

Here are some specific ways that Live Traceability can help with MOSA:

  • Status monitoring: Live Traceability allows systems engineers to monitor the progress of architecture definition in real-time, identifying issues from a requirements perspective as they arise. This can help to increase efficiency and ensure that the stakeholders are aware of changes as they occur.
  • Digital Engineering: Live Traceability can help with digital engineering by providing mechanisms to capture architectures, requirements, risks, and tests including the traceability between individual elements.
  • Configuration and Change Management: Live Traceability can help with change management by tracking changes to system architectures and interfaces including requirements that are allocated to them. This can help to ensure that changes are properly documented and that they do not impact other parts of the system. Baselining and automatic versioning enable snapshots in time that represent an agreed-upon, reviewed, and approved set of data that have been committed to a specific milestone, phase, or release.
  • Testing and Validation: Live Traceability can help with verification and validation to ensure that system meets specified requirements and needs. This can help reduce risk by identifying issues early in the development process and ensuring that the system meets its requirements.
  • Future-proofing: Live Traceability can help to future-proof the system by providing a record of system changes and modifications over time. This can help to ensure that the system remains flexible and adaptable to changing needs and requirements.

In summary, Live Traceability in Jama Connect can help with MOSA by providing real-time visibility into the traceability between architectures, interfaces, and requirements. It can help to improve documenting the system design, identify potential issues, and track changes over time, which are all important considerations for MOSA.


Practical Guide for Implementing Software Validation in Medical Devices: From FDA Guidance to Real-World Application – Part 2

This is part two of a two-part series on software validation and computer software assurance in the medical device industry.

Practical Guide for Implementing Software Validation in Medical Devices: From FDA Guidance to Real-World Application – Part 2

In our previous blog post, we reviewed the top things to know about software validation and computer software assurance in the medical device industry. In this installment, we’ll take a closer look at computer software validation and provide tips and tools to manage your software in a compliant and efficient manner.

Main points

The FDA Draft Guidance on Computer Software Assurance

In September, 2022, the FDA released its draft guidance “Computer Software Assurance for Production and Quality System Software.” While in draft form, the final form for most guidance typically mirrors the draft document. The 2022 supplements the 2002 guidance on Software Validation, except it will supersede Section 6 (“Validation of Automated Process Equipment and Quality System Software”). In this guidance the FDA uses the term computer software assurance and defines it as a “risk-based approach to establish confidence in the automation used for production or quality systems.”

There are many types of software used and developed by medical device companies, including those listed below. The scope of the 2022 draft guidance is on software used in production and quality systems software, as highlighted below.

  • Software in a Medical Device (SiMD) – Software used as a component, part, or accessory of a medical device;
  • Software as a Medical Device (SaMD) – Software that is itself a medical device (e.g., blood establishment software);
  • Software used in the production of a device (e.g., programmable logic controllers in manufacturing equipment);
  • Software in computers and automated data processing systems used as part of medical device production (e.g., software intended for automating production processes, inspection, testing, or the collection and processing of production data);
  • Software used in implementation of the device manufacturer’s quality system (e.g., software that records and maintains the device history record);
  • Software in the form of websites for electronic Instructions for Use (eIFUs) and other information (labeling) for the user.

RELATED: Understanding Integrated Risk Management for Medical Devices

Understanding Your Software’s Intended Use and Risk-Based Approach

Defining the software’s intended use is an important aspect of managing your organization’s computer software assurance activities.

This then allows you to analyze and document the impact to safety risk if the software failed to perform to meet its intended use. One aspect that I appreciate the FDA adopting is the concept of ‘high process risk,’ when the failure of the software to perform as intended may result in a quality problem that foreseeably compromises safety and an increased medical device risk. The guidance has a number of examples to illustrate examples of high process risk and not high process risk. Previously, risk that purely a high risk to compliance only (i.e., no process risk) was essentially treated the same as risk that could compromise safety.

Commensurate with the level of process risk, guidance, and examples are presented to outline expected computer assurance activities, including various levels of testing, and level of documentation. Computer assurance activities for software that poses a high level of process risk include documentation of the intended use, risk determination, detailed test protocol, detailed report of the testing performed, pass/fail results for each test case, any issues found and their disposition, among others.

In contrast, guidance is provided that computer software assurance activities that pose no level of process risk can consist of lower level of testing, such as unscripted ad-hoc or error guessing testing. Prior to this guidance, the expectation was fully scripted protocols and documented results for each test case, which felt burdensome. For example, having to script out protocol steps to include user log-in steps for an electronic QMS module that facilitated the nonconformance process, which did not have a high level of process risk. The usage of the concept of high process risk and acknowledging that unscripted testing can be appropriate in times of low risk, will certainly help lessen the burden of compliance, without compromising safety.

Managing Your Software Efficiently

For those that think analytically like me, once can easily see the value of a Trace Matrix to keep my organization’s software organized and ensure the intended use, risk assessment, planned computer software assurance activities, and outcomes documented.

Similar to how it efficiently traces your medical device design inputs to outputs and links to your risk management, Jama Connect® is a great tool to also trace and manage all your software and software validation and computer software assurance activities. This includes documentation of the intended use, risk determination, and test protocols and reports performed. With its new validated cloud offering, SOC2 certification, and available Jama Connect Validation Kit, Jama Software also provides the tools and evidence you need to meet your organization’s computer software assurance activities.

RELATED: Jama Connect® for Medical Device Development Datasheet

Closing

Developing a risk-based process for software management, including software validation and computer software assurance, is key to staying compliant. Staying organized and using a tool like Jama Connect helps you do so efficiently.

To read part one of this blog, click HERE.


[Webinar Recap] Launch Your Aerospace & Defense Product Development Processes with Jama Connect®

In this blog, we recap the “Launch Your Aerospace & Defense Product Development Processes with Jama Connect®” webinar.

In this webinar, we discuss exciting new features in our updated Jama Connect® for Aerospace & Defense framework. These updates include refreshed solutions for cybersecurity, the DoD Range Safety Requirements Library, and other libraries of standards.

Also, Cary Bryczek, Solutions Director for Aerospace & Defense at Jama Software®, shares best practices in the Jama Connect platform and demonstrates significant new features that can help you further enhance your aerospace and defense product development processes, including:

  • ARP 4761A – Guidelines and Methods for Conducting the Safety Assessment Process on Civil Airborne Systems and Equipment
  • DO-326A – Airworthiness Security Process Specification
  • US CFR Parts 21-57 Pre-imported Libraries and Usage
  • Defense MBSE and Digital Engineering Guidance
  • NASA and Air Force Range Safety Requirements
  • European Cooperate with Space Standards (ECSS) Pre-Imported Libraries

Below is an abbreviated transcript and a recording of our webinar.

Launch Your Aerospace & Defense Product Development Processes with Jama Connect®

Cary Bryczek: Let’s get started. So the Airborne Systems Solution. So when we say solution, it’s really a complete set of frameworks, example projects and the procedural documentation that goes along with that. It’s really intended to accelerate your implementation of Jama Connect, especially those that are developing Airborne Systems and the Airborne Systems components that are going to live on these aircraft. When you utilize these frameworks, you can either have zero set up time, so we’re developed the solution to align with the standards and you can also tailor it. So your consultant who does team with you could help you tailor it to meet your very specific business needs as well. So it’s really designed for any organization, whether you’re a startup in the Airborne Systems world or whether you’re a longtime developer of aircraft.

The Airborne Systems Solution is really designed to help you ease the path to regulatory compliance, to help the engineers produce the evidence and collect that evidence in coordination with the regulatory requirements and the industry standards that are used that are requiring the acceptable means of compliance. Today’s. In today’s world, there is a lot of new engineers that are being employed in Airborne Systems development. And really this particular template is helpful to them because it really gets them to understand “How am supposed to do development?” We all know that Airborne Systems development has the most onerous and rigorous standards of any industry. And teaching our new engineers is very time-consuming. So having this template with all of the guidance built into it and the procedure guide really helps our new engineers to get started.

So there’s three components to the Airborne Systems Solution that what we call the data set, a procedure guide, and the success program. The data set essentially is what you get when you install Jama and it has the templates, it has a ready to use configuration that matches those regulations. It has all of the item types, all of the reports, all of the best practices built right in. And then the procedure guides and the documentation of the reports essentially show you how the Airborne Systems template is meeting the industry standards. So how does it meet ARP4754, how do you use the solution to meet DO-178. That’s sort of a thing.

RELATED: Jama Software® Delivers Major Enhancements to the Jama Connect® for Airborne Systems Solution

Bryczek: And then we also pair our solution with specific consulting. So our consultants already are very familiar with the regulations with working with our customers that have been delivering and developing Airborne Systems already, as well as systems engineering best practices. Some of our customers have interesting supply chain needs. And so they might want to use an additional tool that we package called data exchange. That’s just an add-on to the solution.

So when we look at the framework itself, there are a lot of industry standards that we support. These industry standards are the acceptable means of compliance that the FAA and EASA recognize in order to meet type certifications. So we have those processes that come right out of those standards built right in to the framework. So that framework consists of specially configured item types, pick lists and views of that information. Our relationship rules are aligned to the types of trace matrices these particular standards are calling for. We have workflows and guidance for how you conduct reviews of information as well. We have the libraries of standards, so if you need to comply with the different CFR parts, we actually have those pre imported. This is something new that we’ve added and we’ll talk about that a little bit more. The framework includes these document export templates as well as risk templates and analysis templates and more.

Now this is a company with a procedure guide. So along with not only just the template itself in Jama, we give you the procedure guide. You can take this guide and tailor it to meet your specific needs as well. This procedures guide is updated. So as a subscriber to the Airborne Systems Solution, any updates we make or new releases like what we have right now is included with your subscription. It just makes it easy for everyone to kind of understand “How do I use Jama if I need to meet these industry standards?”

RELATED: Digital Engineering Between Government and Contractors

Bryczek: Also with this particular release is the configuration and update guide. So this is new this time around. This particular guide gives a very detailed description of the entire dataset. It includes all of the types that we’ve defined, all of the pick lists that are defined, all of the relationship rules, all of the workflows. So if you need to update from your existing Airborne Systems Solution and take in aspects of the new release, it makes it really easy for you guys to update as well. This might be something as well… So if you tailor from your existing Jama solution and you want to keep track of that, something like this might be a really great way for you to document your own implementation of Jama itself.

So exciting. This is one of the new things. So we have for cybersecurity, DO-326A is an acceptable means of compliance for doing security analyses. There are a significant number of new item types that have been added to the solution that comprise our cybersecurity solution as well as how do you really do the airworthiness security analysis. Essentially there are seven steps to do this particular type of analysis. This really starts with developing your PSecAC. And for those of you who are maybe new to Airborne Systems development or are not familiar with DO-326 or cybersecurity, it is a process that’s sort of done in tandem with both the system development and safety. But this is different in that this is analyzing the intentional unauthorized electronic interaction. So it’s really designed to find ways that hackers or bad actors might be accessing parts of the Airborne Systems that you don’t want them to.

To watch the entire webinar, visit
Launch Your Aerospace & Defense Product Development Processes with Jama Connect®


Practical Guide for Implementing Software Validation in Medical Devices: From FDA Guidance to Real-World Application – Part I

Practical Guide for Implementing Software Validation in Medical Devices: From FDA Guidance to Real-World Application – Part I

Intro

This is Part 1 of a 2-part series on software validation and computer software assurance in the medical device industry.

While it is clear that software validation is required by regulation in the US and elsewhere (e.g., the EU (European Union)), as regulated by the MDR and IVDR), how to execute continues to cause challenges, both for established medical device companies, and those just entering the medical device industry.

Between the different types of software, variations in terminology, type, and source of software (developed in-house, or purchased OTS, customized OTS (COTS), SOUP, etc.) advances in software technology, and evolving guidance of the FDA (Food and Drug Administration) and other regulatory bodies, it’s no wonder that implementation of software validation practices and procedures causes confusion.

This blog outlines the top things to know about software validation and computer software assurance as you implement practices and procedures for your organization in a way that is compliant and brings value.

Are you building or updating your software validation practices and procedures? If so, read on!

Top Things to Know About Software Validation and Computer Software Assurance

#1. Yes, there are different terms, methods, and definitions for software validation.

For the purposes of this blog, we’ll use the FDA’s definition of software validation, from their 2002 guidance. The FDA considers software validation to be “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.”

At a high level, this makes sense. The confusion starts when folks try to define how that confirmation is performed and documented. How do I determine and document the requirements? How detailed do I need to go to my user needs and intended uses? For each feature? What kind of objective evidence? What if I’m using software to automate test scripts? Do I have to qualify the testing software? Turning to guidance and standards for a “standard” set of practices can add to the confusion. Even within just the medical device industry, there are multiple regulations and standards that use similar and at the same time, slightly different concepts and terminology. Examples include the IQ/OQ/PQ (Installation Qualification / Operational Qualification / Performance Qualification) analogy from process validation, black box testing, unit testing, just to name a few.

Before getting overwhelmed, take a breath and read on to point #2.

RELATED: How to Use Requirements Management as an Anchor to Establish Live Traceability in Systems Engineering

#2. Start with the regulations and standards.

While the multiple regulations and standards around software validation cause confusion, they are also a good place to start. I say that because at a high level they are trying to achieve the same thing- software that meets its intended use and maintains a validated state. Keeping the intent in mind can make it easier (at least it does for me) to see the similarities in the lower-level requirements between any terminology differences and not be as focused on making all the terminology match.

To start, select those regulations and guidance from one of your primary regulatory jurisdictions (like the FDA for the US). In the US, three main FDA guidance documents to incorporate are 1) General Principles of Software Validation; Final Guidance for Industry and FDA Staff, issued in 2002; 2) Part 11, Electronic Records; Electronic Signatures – Scope and Application, issued in 2003.

The 3rd guidance is relatively new, a draft guidance released in September, 2022, Computer Software Assurance for Production and Quality System Software. While in draft form, the final form for most guidance typically mirrors the draft document. The 2022 supplements the 2002 guidance, except it will supersede Section 6 (“Validation of Automated Process Equipment and Quality System Software”). It is also in this guidance that the FDA uses the term computer software assurance and defines it as a “risk-based approach to establish confidence in the automation used for production or quality systems.”

Once you’ve grounded yourself in one set, then you can compare and add on, as necessary, requirements for other regulatory jurisdictions. Again, focus on specific requirements that are different and where the high-level intent is similar. For example, in the EU, Regulation (EU) 2021/2226 outlines when instructions for use (IFUs) may be presented in electronic format and the requirements for the website and eIFUs presented.

#3. Start on the intended use and make your software validation and computer software assurance activities risk based.

Start with documenting the intended use of the software and associated safety risk if it were to fail. Then define the level of effort and combination of various software validation activities commensurate with the risk. Software and software features that would result in severe safety risk if it fails are to be validated more rigorously and have more software assurance activities than software that poses no safety risk.

Here are some examples of intended use and the associated safety risk.

Example 1: Jama Connect®, Requirements Management Software

Intended Use: The intended use of Jama Connect is to manage requirements and the corresponding traceability. The following design control aspects are managed within Jama Connect, user needs, design inputs, and traceability to design outputs, verification and validation activities. Risk analysis is also managed in Jama Connect.

Feature 1 Intended Use: Jama Connect provides visual indicators to highlight breaks in traceability. For example, when a user need is not linked to a design input, or vice versa.

Risk-based analysis of Feature 1: Failure of the visual indicator would result in the possibility of not establishing full traceability or missing establishment of a design control element like a design input. This risk is considered moderate as manual review of the traceability matrix is also performed as required by the Design Control SOP. Reports are exported from Jama Connect as pdfs, reviewed externally to the software, and then approved per the document control SOP.

RELATED: Traceability Score™ – An Empirical Way to Reduce the Risk of Late Requirements

Example 2: Imbedded software in automated production equipment

Intended use: The intended use of the software is to control production equipment designed to pick in place two components and weld them together.

Risk-based analysis: This is a critical weld that affects patient safety if not performed to specification. Thus, the software is considered high risk.

#4. Software Validation and computer software assurance is just one part of the software life cycle… you need to be concerned about the whole lifecycle.

There is more to software development and management than just the validation. Incorporate how custom software will be developed, how purchased software will be assessed to determine the appropriate controls based on risk, including verification and validation activities, and revision controlled.

#5. Have different procedures and practices for the different types of software.

This is a good time to consider how different types of software in your organization will be managed, and it’s not a one-size fits all approach. A best practice is to have separate practices and procedures; one for software in a medical device (SiMD) and software as a medical device (SaMD) and at least one other procedure and set of practices for other software, like software used in the production of a device, software in computers and automated data processing systems used as part of medical device production, or software used in implementation of the device manufacturer’s quality system.

Closing

Stay tuned for Part 2 of this 2-part blog series, where we’ll dive deeper into computer software assurance, highlight the risk-based approach, and provide tips and tools to manage your software in a compliant and efficient manner.


What is a Scaled Agile Framework (SAFe) and How Does it Help with Complex Software Development?

What is a Scaled Agile Framework (SAFe) and How Does it Help with Complex Software Development?

What is a Scaled Agile Framework?

Scaled Agile Framework, or SAFe for short, is a robust framework for managing significant software development projects. It provides guidance on how to organize tasks, manage risk, improve predictability, and maintain the benefits of Agile development.

The SAFe methodology can be used to organize and coordinate large-scale software development projects and is a comprehensive structure that provides guidelines for scaling Agile development methods — from modest, single-team projects to larger, multi-team ones.

SAFe offers a scalable and adaptable approach to task planning and management that reduces risk, boosts predictability, and takes advantage of Agile development’s benefits. The SAFe techniques, roles, and artifacts provide guidance on how to manage dependencies, align teams, and consistently deliver value while enabling teams to work together under a shared framework and language.

SAFe’s essential elements include:

  • Agile Teams: SAFe describes how Agile teams should function as well as the tasks and responsibilities of each team member.
  • Program Backlog: A prioritized list of work that serves as a guide for value delivery.
  • Program Increment: Refers to the time-boxed period of time where teams produce value.
  • Solution Train: The task of coming up with a solution falls under the purview of a multidisciplinary group known as the “Solution Train.”
  • Agile Release Trains (ARTs): A collection of Agile teams working together to create a solution.
  • Value Streams: A series of steps that the organization uses for delivering value to customers.
  • Program Increment (PI) Planning: A regularly scheduled, joint planning session that brings teams in the ART come together to organize and plan tasks, and align on vision, roadmap, and cross-team dependencies.

RELATED: The Easiest Ways to Reduce Product Development Expenses in 2023

What kinds of businesses employ a Scaled Agile Framework?

Organizations that create and deliver complex goods, such as software, often employ the Scaled Agile Framework (SAFe) — particularly in settings where there are many teams, large-scale projects, and numerous stakeholders. SAFe is especially helpful for enterprises that need to manage dependencies, coordinate work across various teams, and consistently deliver value. Organizations across a range of sectors, including technology, finance, healthcare, government, and more, use SAFe.

Due to the fact that SAFe offers a flexible and scalable approach to Agile development, it is employed by both large corporations and smaller companies. The framework is a popular option for firms looking for a complete approach to managing large-scale software development projects, since it can be customized to match the unique demands of each organization.

Do companies have access to software platforms and technologies that facilitate the use of a Scaled Agile Framework in development?

Yes, there are several software platforms and solutions that support Scaled Agile Framework development for businesses. These technologies offer support for a number of SAFe-related features, including as backlog management, value stream mapping, continuous delivery, Agile planning and tracking, and more.

Two popular platforms that support SAFe include:

  •  Jira Software: This popular Agile project management tool offers features like backlog management and Agile boards.
  • Azure DevOps (formerly Visual Studio Team Services): A Microsoft solution that offers support for Agile project management, continuous delivery, and more.

These are only a couple of the many tools that businesses using SAFe have access to. The best tool for a company depends on its individual requirements and preferences, and many companies decide to utilize a variety of tools to support various SAFe implementation components.

RELATED: Research Notes: Traceability Score™

How Can Jama Connect® Help Organizations Adopt a Scaled Agile Framework?

Jama Connect® is a product, systems, and software development platform that can help organizations adopt and implement a Scaled Agile Framework (SAFe), and provides support for various aspects of SAFe, including:

  • Requirements Management: Jama Connect provides a centralized repository for managing requirements and product backlogs, helping organizations align work with their product strategy and vision.
  • Traceability: Jama Connect manages requirements with Live Traceability™ across the end-to-end development process — from requirements to design and implementation — helping organizations manage dependencies and ensure that work is aligned with their goals.
  • Collaboration: Jama Connect provides a platform for teams to collaborate on product development, improving communication and reducing risk.
  • Quality Assurance: Jama Connect offers a platform for managing quality assurance operations, including as test case management, test execution, and defect tracking, to assist businesses make sure that their products fulfill consumer needs.
  • Reporting: Jama Connect offers analytics and reporting tools that help businesses assess their progress, spot potential dangers, and make wise decisions.

RELATED: Traceable Agile – Speed AND Quality Are Possible for Software Factories in Safety-critical Industries

Jama Connect integrates with other tools like Jira and Azure DevOps to offer a complete SAFe solution for businesses. Additionally, due to the platform’s adaptability and configuration options, companies can tailor Jama Connect to their organization’s unique needs and operational procedures.

Jama Connect is the #1 Industry-leading software for requirements management and Live Traceability™. This robust, but easy-to-use platform enables collaboration, quality assurance, and reporting for enterprises looking to build a Scaled Agile Framework (SAFe) and can help businesses boost productivity, generate better products more quickly, and optimize their product development processes.

In conclusion, large-scale software development projects can be managed and coordinated using the Scaled Agile Framework (SAFe) approach. It is a thorough framework that offers instructions on how to scale Agile development processes from small, single-team projects to big, multi-team ones. While maintaining the advantages of Agile development, it offers a scalable and adaptable way to plan and manage work, lowering risk and raising predictability.

To learn how Jama Connect can help your organization adopt a Scaled Agile Framework, contact us to speak with one of our experts!

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Karrie Sundbom and Josh Turpen.

Jama Software® Delivers Major Enhancements to the Jama Connect® for Airborne Systems Solution

In this blog, we recap our press release, “Jama Software® Delivers Major Enhancements to the Jama Connect® for Airborne Systems Solution” – To read the entire thing, click HERE

Jama Software® Delivers Major Enhancements to the Jama Connect® for Airborne Systems Solution

Accelerate and optimize airborne systems development with a new set of supported frameworks, projects, and standards

Jama Software®, the industry-leading requirements management and traceability solution provider, has announced enhancements to its Jama Connect® for Airborne Systems solution. Jama Software is committed to continuously enhancing its industry solutions, enabling customers to easily manage requirements, achieve Live Traceability™ and accelerate systems development.

The Jama Connect for Airborne Systems Solution is a complete set of frameworks, example projects, and procedural documentation used to accelerate the implementation of Jama Connect for organizations developing airborne systems and components. This is the third major upgrade to the solution since 2019 and these new capabilities are available to existing and new customers alike. The update both refines the existing solution elements and expands the scope of the solution to meet airborne safety and cybersecurity standards ARP4761A and DO-326A respectively.

“Having all of the applicable 14 CFR regulations preloaded at the beginning of a new project greatly accelerates assigning the driving requirements without extensive data entry.”

Jeffrey Spitzer, Chief Engineer at Transcend Air

The newly upgraded Jama Connect for Airborne Systems provides the following benefits:

  • Reduced adoption time of new standards such as ARP4754A/DO-178C/DO-254/ARP4761A when developing complex airborne systems
  • Reduced deployment time and risk of negative outcomes with defined and justified configuration, export templates, and reports
  • Increased confidence and decrease time-to-value with an established scope and direct alignment of requirements for Airborne Systems

“Jama Software continues to lead with innovation and work alongside our customers to invest deeply and cater to the needs of the Aerospace and Defense (A&D) industry. The Jama Connect for Airborne Systems solution has enhanced support and provides a standards-compliant framework that can streamline compliance demonstration for aviation system development. This is a major milestone for us! And we are here to help our customers stay ahead of the rapidly changing Aviation industry.”

Cary Bryczek, Director of Aerospace and Defense Solutions at Jama Software

The Jama Connect for Airborne Systems Solution consists of multiple components that make up a ready- to-use configuration including:

  • Airborne Systems Dataset: Includes frameworks and sample sets aligned to ARP4754A, ARP4761A, DO-178C, DO-254, DO-326A along with US Code of Federal Regulations Airborne Systems Library (eCFR) – pre-imported Title 14, Subchapter C, Parts 21-59.
  • Procedure Documentation and Reports: The procedure documentation provides teams with straightforward processes that they can follow to make the best use of Jama Connect in compliance with the standards included in the dataset.
  • Data Exchange (Add-On): This utility allows the exchange of requirements, architecture, and tests across the supply change and between tools using the industry standard ReqIF format.
  • Success Program (Add-on): Includes an Aerospace and Defense Jama Consultant to optimize your Jama Connect configuration, teach best practices, and train your team.

“Jama Connect has enabled Ursa Major to document airborne systems requirements and track verification closure in a streamlined and organized way which has enhanced communication and success between our teams.”

Maggie Mueller, Systems Engineer at Ursa Major Technologies, Inc.

To learn more about Jama Connect for Airborne Systems Solution, please visit our
 Aerospace and Defense page. If you would like to speak with one of our industry experts and book a free Jama Connect trial click here.

Read the entire press release here!
Jama Software® Delivers Major Enhancements to the Jama Connect® for Airborne Systems Solution


Five Advantages of Cloud Over On-Premises for Your Requirements Management and Traceability Solution

Editors Note: In this blog post, we cover the five advantages of cloud over on-premise software deployment. To learn more about the advantages of a Jama Connect® cloud deployment and key considerations when choosing a cloud-based engineering tool provider, please read the full whitepaper here. 

Cloud over On-Premise: An Introduction

Business is changing. In a world where remote work models are growing more common, teams are widely dispersed, and technology services are commonly hosted in the cloud, companies that are still managing requirements and traceability with an on-premises system may find themselves losing competitive advantage. Keeping an edge over the competition could come down to how quickly you can develop a product and get it to market, thus your requirements management system is of paramount importance.

Wading into the world of cloud deployments might seem risky. How can you manage data and software when it’s not on your premise? How can you ensure data security? Can you ensure uptime when the infrastructure is not under your control? Does it matter where my data is stored? Plus, numerous other questions you might be asking yourself.

While some kind of formalized requirements management solution is certainly better than none, there are distinct and significant advantages to a cloud deployment over an on-premises deployment.

Hosting your software and data on-premises essentially means that your organization is responsible for installing and maintaining all the deployment of updates and patches, server and memory sizing, redundancy, disaster recovery, back-ups, performance, latency, data storage and management, security, uptime, accessibility, and the items go on and on. This responsibility could include keeping everything in your own physical location with your own servers, but it can also mean using your own cloud storage or cloud service, such as AWS, for hosting. With an on-premises deployment of your requirements management software, your IT department will be responsible for all the management and upkeep of your software and data, including any troubleshooting.

With a cloud deployment, you purchase the number of licenses you need, and then all the responsibility for the hosting and management of software and data is held by the software provider. The software provider manages all aspects of the set-up and running of the software. In this model, you are only responsible for paying for the subscription; the software provider updates and patches, maintains security, hosts and backs up the data, ensures uptime, and provides troubleshooting when necessary.

A cloud deployment offers a host of advantages for even the smallest deployments. Here are five reasons to think about moving your requirements management solution to a multi-tenant SaaS environment:

1. A cloud deployment reduces your risks

When you deploy on-prem, you place all the risk of equipment failure, downtime, performance and latency, and data breaches on your own organization. If servers go down, you bear the cost of downtime, including lost productivity and potential lost data. Downtime is expensive, both in real dollars lost and in lost reputation. Uptime Institute’s 2022 report found that 60% of outages cost over $100,000; in manufacturing, downtime can cost up to $5 million per hour, according to ITIC.

Data breaches could cost even more. A data breach into your own servers or your hosted cloud service could compromise progress on projects. In addition, your organization becomes responsible for all regulatory compliance that concerns your data and software. The additional steps to satisfy compliance could add time to market in addition to adding cost to your projects.

By moving your requirements management solution to the cloud, your software vendor bears the risk. Your provider must fulfill the terms of the contract with guaranteed uptime and security protocols, relieving your organization of responsibility for those risks. More importantly, when your software provider must meet industry security standards through independent auditing, you can rest assured that your data is safe and secure without undergoing rigorous auditing within your own organization.

2. A cloud deployment allows you to better manage IT resources

Most IT departments are understaffed and overwhelmed. A 2019 survey of IT decision makers found that 86% of them say it’s challenging to find IT professionals. Once they are hired, they often have to manage everything from servers to phone equipment to onsite security to software rollouts, making it difficult to gain or hone expertise in any single technology.

When you opt for an on-premises deployment, your IT department will bear the responsibility for managing software updates, data storage, and troubleshooting for your requirements management software. Not only does this type of deployment add one more thing to your overworked IT staff, but it also puts this business-critical software in the regular queue with everything else.

With a cloud deployment hosted by your software provider, you can transfer the resource management of your software and data to people who are already experts in requirements management software and cloud hosting. Software updates roll out quickly in the cloud, and you gain instant access to a knowledge base and expertise that your on-site IT staff may not have while freeing IT to pursue other critical projects.

RELATED: When evaluating product development software tools,  not all cloud is equal – learn more about the differences

3. A cloud deployment saves you money

Deploying an on-premises solution doesn’t just involve hardware expenses and software licenses. In addition to the cost of IT resource management, your on-premises deployment will also likely involve costs such as security software for every server, fees to upload to your own cloud service for backup, extra firewalls, security reviews, and PEN tests. These costs add up quickly and come straight out of your IT budget.

In contrast, with a cloud deployment, you pay one fee per license required, and your software vendor takes on the obligation for maintaining security, uptime, and all other IT costs. The total cost of your per user licenses will likely be far less than the total cost of an on-premises deployment.

4. A cloud deployment improves business continuity

Building and IT emergencies happen, and if you lose access to your building or servers go down, it will take time to restore servers or access data stored from a remote location. Even a short period of downtime can result in tens of thousands of lost dollars, and yet a PWC survey found that 95% of business leaders say their crisis management capabilities “need improvement.”

With cloud deployment, your team can work from anywhere, anytime, with guaranteed access to software and data, allowing you to rest assured knowing that your data is protected. Your software vendor bears the responsibility for uptime guarantees, and with built-in layers of redundancy, outages are rare or very brief.

5. A cloud deployment offers easy scalability

With an on-premises deployment, your organization is limited by its available data capacity, whether that involves a physical server room or an amount of data capacity purchased in the cloud. As your organization grows, additional physical servers or additional cloud storage become necessary, and it’s possible that hiring just one or two people could require purchasing more hardware and attendant software licenses than are necessary.

A cloud deployment makes scalability easy by allowing the purchases of individual licenses as your company grows, so that you are never paying for more licenses than you need. In addition, data storage comes with the license, so you never have to worry about outgrowing your server room, your IT staff, or your cloud storage subscription fee.

Jama Connect® Cloud Deployment

Jama Connect is the only requirements management platform that creates Live Traceability™ through a multi-tenant cloud deployment. Ensure you understand the cloud deployment model of your potential software providers and evaluate the pros and cons while also understanding where the system and your data will be stored. It may be the difference between a scalable, highly available, secured environment vs. a single point of failure that isn’t secured or compliant with today’s rigorous security standards.

Jama Software® Partners with Sterling PLM (Now Vantage Medtech): Expands Lifecycle Management and Live Traceability™ Expertise OfferingsIn this blog, we recap our press release on Jama Software® partnering with Sterling PLM.

Jama Software® Partners with Sterling PLM (Now Vantage Medtech)

Expands Lifecycle Management and Live Traceability™ Expertise Offerings

Jama Software®, the industry-leading requirements management and traceability solution provider and Sterling PLM (now Vantage Medtech), an industry leader in engineering management problem-solving, have partnered together to expand expertise and offerings across requirements management and Live Traceability™ solutions.

“Jama Software’s world-class consulting organization — that spans across multiple verticals including medical device development — will be greatly complemented by this partnership with Sterling PLM. Sterling PLM expands on our already comprehensive services that drive measured improvements across product development processes that result in faster time to market and higher product quality.”

Tom Tseki, Chief Revenue Officer at Jama Software®

Jama Connect® is the only platform that delivers Live Traceability™ across engineering disciplines through the entire product development process to reduce defects, delays, rework, and cost overruns. Sterling PLM‘s team has decades of combined experience consulting in highly regulated industries for a variety of medical device manufacturers. By partnering with Jama Software, Sterling PLM (now Vantage Medtech) will collaborate and support lifecycle management services around configuration, training, and process development.

“At Sterling PLM, we have years of experience cultivating superior technical and lifecycle management know-how. We pride ourselves on our ability to anticipate problems before they become apparent to our clients. We are excited to add Jama Connect to our arsenal of technology solutions, adding to our capability to apply our specialized expertise and customized approach to solving problems for our clients.”

Dan Sterling, President, Chief Executive Officer, and Founder at Sterling PLM

Jama Software has consistently been listed as the leader in Requirements Management software tools by G2® for the fourth consecutive reporting period. By combining Sterling PLM’s customized solutions and seasoned expertise in lifecycle management technologies and Jama Software’s industry-leading requirements management and traceability offerings, Jama Software and Sterling PLM will continue to accelerate transformation to serve the needs of medical device developers.

“We’re especially excited to leverage the expertise and experience of the Sterling PLM (now Vantage Medtech) team with our Medical Device customers. They’ll be a great addition to our out-of-the-box solutions for medical device developers and provide specialty services such as computer systems validation and legacy tool data migration.”

Vincent Balgos, Director, Medical Solution at Jama Software

About Sterling PLM
Sterling PLM helps engineering companies across the globe implement proven processes that govern the design and development of their engineered products while leveraging software that tracks processes with greater visibility across the enterprise. Our team has decades of combined experience consulting in highly regulated industries for a variety of manufacturers—from small start-ups to large global organizations—and we’ve spent years cultivating unique skills and concentrated expertise in the business of engineering. We specialize in regulatory-compliant software programs that help customers track the project artifacts that they care about—across the entire project lifecycle.

About Jama Software
Jama Software is focused on maximizing innovation success. Numerous firsts for humanity in fields such as fuel cells, electrification, space, autonomous vehicles, surgical robotics, and more all rely on Jama Connect® to minimize the risk of product failure, delays, cost overruns, compliance gaps, defects, and rework. Jama Connect uniquely creates Live Traceability™ through siloed development, test, and risk activities to provide end-to-end compliance, risk mitigation, and process improvement. Our rapidly growing customer base of more than 12.5 million users across 30 countries spans the automotive, medical device, life sciences, semiconductor, aerospace & defense, industrial manufacturing, financial services, and insurance industries. For more information about Jama Connect services, please visit www.jamasoftware.com

Read the entire press release here:
Jama Software® Partners with Sterling PLM: Expands Lifecycle Management and Live Traceability™ Expertise Offerings

View Synonyms and Definitions

Jama Connect® for Semiconductor Software: Modernize and Digitize the Requirements Management Process

In this blog, we’ll break down key elements of our Jama Connect for Semiconductor Software. 

Jama Connect® for Semiconductor Software

It can take months or even years to complete the development of a new chip. To avoid costly mistakes, semiconductor requirements need to be clearly communicated to the entire team across the development lifecycle. While most teams acknowledge their communication challenges, the risk of process change or adopting a new tool can be daunting. Jama Connect for Semiconductor provides an intuitive, leading-edge semiconductor requirements management solution for complex chip development with methods in use today by top manufacturers.

Supercharge Your Systems Development and Engineering Process

Jama Connect® is a solution for managing product requirements from idea through development, launch, and iteration. It brings people and data together in one place, providing visibility and actionable insights into the product development lifecycle. Jama Connect equips teams to analyze impacts, track decisions, and ensure quality of the product you set out to build.

Simplify Complex Product Development With Jama Connect

Jama Connect is a hub for understanding your complete product development lifecycle, enabling product managers and engineers to track requirements, decisions, and relationships on multiple levels to deliver compliant, market-driven products effectively. Jama Connect helps teams deliver high-quality products on time and on budget by aligning stakeholders, identifying risks early on and visualizing connections between regulations, requirements, and test cases throughout the development process.

Key Benefits

In the increasingly complex semiconductor industry, market forces are creating new challenges for semiconductor product developers. Jama Connect was designed to help teams:

  • Confidence – Trace requirements throughout the development process, illuminate risk, and proceed with confidence that you are building what you set out to build.
  • Visibility – Gain visibility into the product development process by monitoring relationships and dependencies between systems, teams, activities, and results.
  • Speed – Align teams, track decisions efficiently, and minimize rework to create high-quality products on time and on budget.
  • Adaptability – Easily adapt Jama Connect to your project and organizational workflows to create an intuitive experience so your teams can get up to speed quickly.
  • Performance – Benchmark and monitor team performance over time to understand the benefits of retooling your product development process. Store and reuse existing intellectual property and best practices from multiple product lines.
Download the entire Datasheet – Benefits of Jama Connect®: Supercharge Your Systems Development and Engineering Process 

RELATED: 3 Semiconductor Procurement Pitfalls To Avoid

How Jama Connect Helps Our Customers

Infineon Transitions From a Document-Centric to Data-Centric Development Flow with Jama Connect

Founded in 1999 as a spin-off of Siemens AG, German semiconductor manufacturer, Infineon Technologies AG is a world leader in semiconductor solutions that make life easier, safer, and greener. Ranking among the 10% most sustainable companies in the world, Infineon is a leading player in automotive, digital security systems, power and sensor systems, and industrial power control.

In our Infineon customer story, we examine how Jama Software helps Infineon manage complex product development subject to regulatory compliance and increase efficiency. Read the full customer story to find out how Infineon’s shift from a document-based approach to a more modern requirements management solution resulted in:

  • Better management of product complexities throughout the development cycle
  • Systematic handling of requirements from product definition to product development and verification
  • Improved collaboration with distributed teams both inside and outside of their organization
  • More effective exchange of requirements to ensure functional safety standards are met

RELATED: Enabling Digital Transformation in the Semiconductor and Hardware Space

INFINEON CUSTOMER STORY OVERVIEW

Database-centric approach increases the efficiency of Infineon product development

Jama Connect helped Infineon shift from a document-based approach to a more modern requirements management solution enabling newfound product development efficiencies around complexities, communication, reviews, and compliance.

CHALLENGES

• Keep the overview on ever-increasing product complexities and avoid requirements misunderstandings
• Provide compliance without compromising time-to-market goals
• Manual document versioning makes review cycles and alignment difficult
• Improve the review & sign-off process, making it an integral part of the requirement management system
• Need for enhanced reuse capabilities • Exchange requirements information with customers and suppliers
• Overcome the scaling limits of a document-centric approach

SOLUTIONS

• Jama Connect’s scalability supports complex projects
• Easier to show compliance to industry regulations
• Jama Connect Review Center supports an efficient process
• Provide requirements-accurate versioning to backtrace decisions
• Reuse requirements to shorten development cycles
• Digital exchange of requirements between customers and suppliers

RESULTS

• Better management of product complexities throughout the development cycle
• Systematic handling of requirements from product definition to product development and verification
• The traceability of requirements enables functional safety standards compliance
• Improved collaboration with distributed teams both inside and outside of their organization
• More effective exchange of requirements to ensure functional safety standards are met

Download the Customer Story – Infineon Transitions From a Document-Centric to Data-Centric Development Flow with Jama Connect

A Guide to Good Systems Engineering Practices: The Basics and Beyond

In this blog, we overview Part 1 of our eBook, “A Guide to Good Systems Engineering Best Practices: The Basics and Beyond” in which we discuss the fundamentals of systems engineering best practices, the “V” model,  the characteristics of good systems engineering, and lessons learned. To read the entire eBook, download it HERE.

A Guide to Good Systems Engineering Best Practices: The Basics and Beyond.

In the first part of this eBook, we discuss:

  • The fundamentals of systems engineering
  • The role of a systems engineer
  • Systems engineering process
  • The “V” Model of systems engineering

Part I: The Basics of Systems Engineering

What is systems engineering?

Systems engineering is an engineering field that takes an interdisciplinary approach to product development. Systems engineers analyze the collection of pieces to make sure when working together, they achieve the intended objectives or purpose of the product. For example, in automotive development, a propulsion system or braking system will involve mechanical engineers, electrical engineers, and a host of other specialized engineering disciplines. A systems engineer will focus on making each of the individual systems work together into an integrated whole that performs as expected across the lifecycle of the product.

What are the fundamentals of systems engineering?

In product development, systems engineering is the interdisciplinary field that focuses on designing, integrating, and managing the systems that work together to form a more complex system. Systems engineering is based around systems-thinking principles, and the goal of a systems engineer is to help a product team produce an engineered system that performs a useful function as defined by the requirements written at the beginning of the project. The final product should be one where the individual systems work together in a cohesive whole that meets the requirements of the product.

What is a system?

A system is a collection of different elements that produce results that individual elements cannot produce. Elements or parts can be wide-ranging and include people, hardware, software, facilities, policies, and documents. These elements interact with each other according to a set of rules that produce a unified whole with a purpose expressed by its functioning. An example of a system is the human auditory system; the system includes individual parts in the form of bones and tissue that interact in a way to produce sound waves, which are transferred to nerves that lead to the brain, which interprets the sounds and formulates a response. If any single part in the auditory system fails or experiences disruption, the entire system can fail to perform its function.

What is systems thinking?

Systems thinking is a way of thinking that looks at the overall function of a complex system rather than breaking it down into smaller parts. For example, systems thinking would consider an automobile a complex system that consists of smaller, specialized elements. While an electrical engineer might only be concerned with the electrical system of the automobile, someone looking at the entire complex system would consider how the electrical system would impact other systems in the automobile — and how those other systems might impact the electrical system. If one piece of the electrical system fails, for instance, how would that failure cascade to other systems to impact the operability of the automobile? Systems thinking will take a “big picture” approach to the overall product.

What is the role of a systems engineer?

A systems engineer is tasked with looking at the entire integrated system and evaluating it against its desired outcomes. In that role, the systems engineer must know a little bit about everything and have an ability to see the “big picture.” While specialists can focus on their specific disciplines, the systems engineer must evaluate the complex system — as a whole — against the initial requirements and desired outcomes. Systems engineers have multi-faceted roles to play, but primarily assist with:

  • Design compatibility
  • Definition of requirements
  • Management of projects
  • Cost analysis
  • Scheduling
  • Possible maintenance needs
  • Ease of operations
  • Future systems upgrades
  • Communication among engineers, managers, suppliers, and customers in regard to the system’s operations

RELATED: The Complete Guide to the Systems Engineering Body of Knowledge (SEBoK)

How can systems engineers help improve traceability?

For many systems engineers, balancing the needs of the individual systems and their engineers against the system as a whole results in addressing problems after the fact, holding unwanted meetings, and trying to persuade others to change behavior. Many organizations may not adequately focus on requirements and traceability, resulting in a lack of data that would allow a systems engineer to better evaluate the product. To avoid constantly chasing problems and start streamlining processes, systems engineers can use three best practices:

Baseline the current traceability performance:

Traceability spans the product development process, and product team members understand the value of data management, especially as concerns meeting industry requirements. By establishing a baseline of traceability performance, the entire team will be able to see existing risks and potential savings and improvements. In addition, a baseline can give a foundation for a plan of action to move toward Live Traceability™.

Build the business case for Live Traceability:

With a baseline in hand, systems engineers can offer a case for moving to Live Traceability based on data. The data can establish the ROI, productivity improvements, and risk reduction of moving from static traceability to Live Traceability.

Create quick wins:

Once the advantages of Live Traceability are established, the systems engineer can set up continuous syncing between requirements and task management programs, thus automating traceability from requirements to user stories. This simple shift can help demonstrate the value of shifting from after-the-fact traceability to Live Traceability.

RELATED: Better Product Development: Five Tips to Achieve Live Traceability™

What is the systems engineering process?

The systems engineering process can take a top-down approach, bottoms up, or middle out depending on the system being developed. The process encompasses all creative, manual, and technical activities necessary to define the ultimate outcomes and see that the development process results in a product that meets objectives. The process typically has four basic steps:

1. Task definition/analysis/conceptual: In this step, the systems engineer works with stakeholders to understand their needs and constraints. This stage could be considered a creative or idea stage where brainstorming takes place and market analysis and end user desires are included.

2. Design/requirements: In this phase, individual engineers and team members analyze the needs in step one and translate them into requirements that describe how the system needs to work. The systems engineer evaluates the systems as a whole and offers feedback to improve integration and overall design.

3. Create traceability: Although we’re listing traceability here as the third step, traceability is actually created throughout the lifecycle of development and is not an isolated activity taking place during one phase. Throughout the lifecycle of development, the team works together to design individual systems that will integrate into one cohesive whole. The systems engineer helps manage traceability and integration of the individual systems.

4. Implementation/market launch: When everyone has executed their roles properly, the final product is manufactured or launched with the assurance that it will operate as expected in a complex system throughout its anticipated lifecycle.

RELATED: Adopting the EARS Notation to Improve Requirements Engineering

The “V” diagram of systems engineering

Developed in the 1980s, the “V” Diagram of Systems Engineering is a way of specifying the specific series of steps that make up a systems engineering approach. While it was originally employed in a pre-Agile environment, it still has relevance to product development today and can enable faster, less risky product development. The “V” diagram allows system engineers multiple viewpoints and opportunities to evaluate systems as they integrate with each other. This approach starts with the desired outcomes and objectives and then deconstructs them into individual systems and system components for the purpose of design. Once the requirements and design details are established, individual systems can be tested and evaluated, then integrated into the overall piece for testing and verification. As the systems are integrated and become closer to the final complex system, teams have multiple opportunities to validate and verify concepts, requirements, and design.

For the systems engineer, the “V” Model can give a clear roadmap that allows the breakdown of the complex system into smaller parts and then the reintegration and reassembly of the pieces into a cohesive whole. With systems broken down to individual components, traceability, requirements management, and testing and validation become more manageable. In addition, as the pieces are reintegrated into the whole system, the “V” Model allows for an iterative process that gives a clearer view into potential risks and helps troubleshoot problems. Systems engineering is a discipline that’s vital to the success of a complex system. By including systems engineers in all stages of product development and requirements management, teams can reduce risks, improve time to market, and produce better products that more adequately meet end user requirements.

Why is Live Traceability Essential? Given the complexity of products today, it takes multiple team members to weigh in on key decisions. And the number of decision points are only growing as products get more complex, making it even harder to adequately weigh all the options and trace their impacts. Learn more.

To read Part 2 of “A Guide to Good Systems Engineering Best Practices: The Basics and Beyond”, download the entire eBook HERE.