Tag Archive for: end-to-end traceability


Live Requirements Traceability

Achieving Live Traceability™ of product requirements, as necessitated by industry standards, across siloed engineering teams and tools, is the #1 unsolved problem for most product development organizations. One of the main barriers is that each engineering discipline (systems, software, hardware, electrical, risk, verification and validation) has optimized its own process and tools. When looking at the end-to-end product development process siloed teams, tools, and data make it very challenging to trace development activity from initial requirement definition through development and testing. 

As a result, requirements traceability becomes a time-consuming, error-prone, frustrating, and manual, after-the-fact process. The inability for the product development organization to continually trace ongoing development efforts and changes back to user and system requirements results in missed requirements, defects, rework, delays, audit letters, and cost overruns. 


RECOMMENDED READING: Requirements Traceability: How to Go Live


No common platform exists 

The typical approach to solve this generic process problem with software is to force every user onto a single platform and follow one common process. This works for standard business processes in HR, Sales, and Finance, but engineering disciplines across systems, software, hardware, electrical, risk, test, verification, and validation each follow different methodologies and use multiple tools including spreadsheets, desktop, and homegrown applications. Each engineering discipline has optimized their own development environment and strongly resist any attempts to change. Engineering leadership defers to each engineering discipline to define how to best do their work and is loath to dictate processes and tools that will negatively impact the performance and morale of each engineering team.  

In addition to the organizational barriers to standardization, no single platform is even close to currently existing which replaces these dozens of tools. A single platform would need to cover all of the following software categories AND address all functionality in spreadsheets (Excel), scripts, desktop, and homegrown tools: Requirements Management, CAD, MBSE, DFMEA/FMEA, software task management, software code management, automated software testing, hardware bench test tools, ALM, PLM, and more. Current efforts by legacy vendors to create a common SaaS platform to span all these software categories and reach parity with best-of-breed tools is moving very slowly.   


RECOMMENDED READING: Benefits of End-to-End Traceability


How to achieve Live Traceability™ without forcing change on engineering teams 

So how does an organization achieve Live Traceability across a best-of-breed tool environment supporting disparate methodologies, terminologies, fields, and statuses? The answer is a 3-step approach: 

Step One | Live Traceability Model 

Define a Live Traceability model across the end-to-end product development process with relationship rules for the traceable data elements across best-of-breed tools. An automotive functional safety example is shown below. Here you can see the operational instantiation of functional safety standards requirements in a relationship model within Jama Connect®. All necessary traceable information is included with continuous syncs to best-of-breed tools within engineering teams to deliver Live Traceability.  

Step Two | Adaptive Data Field Mapping 

To achieve Live Traceability, integrations with best-of-breed tools (such as those shown in the example) are required. The typical integration approach standardizes field names and statuses to ensure consistency across the connected tool, but this does not achieve the dual objective of Live Traceability with no changes required in how each engineering team works. Alternately, the proven approach is to apply adaptive data field mapping to ensure no change to engineering teams’ fields and statuses which simultaneously ensures a consistent, process wide, Live Traceability model. This is achieved through robust mapping and normalization logic functionality to easily address the various approaches taken by each engineering team. 


RECOMMENDED READING: Requirements Management Guide: Requirements Traceability


Step Three | Management by Exception 

Once Live Traceability is achieved, engineering organizations can — for the first time — manage the end-to-end product development process in real time, identify exceptions to the process early, and take action to significantly reduce defects, rework, delays, and cost overruns.  

LEARN MORE




This is Part 2 of a series examining the role legacy requirements management solutions, such as IBM® DOORS®, play in introducing project risk to the product development process. To read Part 1,  visit Why Migrate, Why Now?: Part 1

5 Common Migration Myths Debunked

Transitioning to a new solution doesn’t have to be challenging; however, there are some assumptions that mislead us into thinking that difficulty is inevitable. Consider the following myths:

MYTH 1: Migrating away from IBM solutions will be more expensive. The amount of work that goes into upgrading to IBM DOORS Next or transitioning to a new RM solution is the same, differentiated only by the quality of the tool and services available to help with migration. An option other than the DOORS family is most often a better fit for your organization.

MYTH 2: Customization will carry over to DOORS Next. You spent a lot of time customizing IBM DOORS and may believe those customizations will transition seamlessly to DOORS Next. However, this isn’t the case and is the reason selecting a different solution doesn’t involve more work.

MYTH 3: DOORS is already deployed and cheap to maintain. Continuing the current path with IBM DOORS is an expensive option in the long term, and often requires dedicated personnel. Switching to an alternative RM solution can improve efficiency while saving money.

MYTH 4: Business disruption is too difficult. The right RM tool will empower teams to effectively hit deadlines, collaborate, and improve business outcomes.

MYTH 5: The user experience will suffer. Many people refuse to use DOORS due to a challenging user experience. DOORS Next is a completely new tool with a new user experience. Adopting a user-friendly solution allows teams to collaborate far more effectively as team members can accelerate concepts, designs, and validations for faster times to market.

requirements-management-hub

The fact is, IBM® DOORS® is extremely outdated, and at some point, updates and support will inevitably end.

If you’re currently using DOORS, you likely know that moving to a different solution is necessary, and you might be considering DOORS Next. However, fast-shifting market dynamics require a new approach to accelerate innovation. As a modern alternative to traditional legacy platforms, Jama Connect® enables digital transformation with a more efficient and user-friendly approach to managing risk and compliance.

Customers agree, naming Jama Connect the overall leader (#1) in requirements management software on G2, outranking IBM DOORS Next for implementation time, adoption, ROI, and market presence.

Jama Connect is a proven IBM DOORS alternative with flexible and reliable solutions, including:

  • Operation in an IBM DOORS supply chain.“Innovative companies leverage Jama Connect to get up and running fast with a modern requirements management process that tightly aligns with industry standards and practices that support regulatory compliance. Organizations can connect to customers and suppliers that use IBM DOORS through Data Exchange for Jama Connect.”
  • Integration services. Jama Connect provides integration with key product development lifecycle tools.
  • Coexists with IBM DOORS. IBM DOORS is embedded in many organizations and may take some time to migrate completely. Progressive teams and divisions can get started on Jama Connect quickly while the larger organization works toward replacing existing programs over time. This approach is supported through a mix of integration, migration, and exchange services.

“Jama Connect lowers the complexity and burden of having to manually keep requirements, architecture and specifications all in sync and traced to each other. It’s a formidable problem that is virtually eliminated courtesy of Jama without the hassle of having to learn a clunky UI (IBM DOORS).” Alan M., Chief Product Officer

Jama Connect® created Live Traceability™ management which reduces project development risk by forming a digital thread through siloed development, test, and risk activities. The flexible platform is designed to support the end-to-end product development process with:

  • A simple, single repository so it’s easy for remote teams to gather, review and execute on requirements.
  • Structured reviews and collaboration — teams can elicit feedback, review product features in real-time with stakeholders and track critical decisions across teams and locations.
  • Change management throughout product development — end-to-end traceability and real-time collaboration improve visibility and make it easier to adapt to changes and track their impact.
  • Integrations across the ALM-PLM ecosystem.

Moving from IBM® DOORS® Next to Jama Connect® for Requirements Management

To adapt to shifting and ever-increasing challenges and complexities and keep pace with the competition, innovative organizations are now requiring best-in-class software to scale development, reduce risk, save time, and ensure compliance to quality and safety regulations.

Download this paper to learn how Jama Connect stands out above DOORS Next in the G2 Summer 2021 report for requirements management in the following areas:

  • Overall satisfaction
  • Implementation
  • User adoption
  • ROI

Go live with Jama Connect 2.7x faster than IBM® DOORS Next®


In Conclusion

Products, systems, and software development are only getting more complex and not modernizing your requirements management process will increase the probability of negative outcomes in your product development process.

As your team requires the ability to adapt, innovate, and grow, continuing to use IBM DOORS will become more difficult and will introduce significantly more risk in your product development process. Think about DOORS as a landline rotary phone that stopped being on the receiving end of upgrades after the industry switched to marketing push-button touchtone phones. (And now there are smartphones available, which are mobile and make you even more connected and productive.)

Transitioning to new technology provides your teams with the tools required to innovate, meet deadlines, and succeed. A modern requirements solution can help you to define, manage, and validate complex systems requirements while eliminating the risks and inefficiencies associated with documents and legacy systems.

Hear about the experiences of the more than 50 companies that have made the switch from IBM DOORS to Jama Connect.

Connect with us today to learn how you can enable end-to-end compliance, risk mitigation, and process improvement with our intuitive, award-winning requirements management platform.

To read this series in its entirety, visit this whitepaper: Why Move Away from IBM Doors Legacy and Why Now

 



requirements traceability

In this post, we recap a recent webinar hosted by Jama Software on the topic of requirements traceability. 


As the product and software development process grows in complexity, with more and more teams adding information, it is becoming increasingly difficult to track requirements throughout the development lifecycle and for stakeholders to get a clear view. Every decision can have an impact on the requirement or the product itself.

How do you prevent your organization from wasting time and resources, repeating research and searching for information, and how do you ensure that final deliverables tie in directly to the initial business needs?

That’s where requirements traceability becomes very important.

In this webinar, we walk through the challenges of requirements traceability and how you can utilize Jama Connect to overcome them. Watch the webinar to see how to provide backward and forward visibility for requirements, but also other information about the product you are building. You will also see how easy it is to do an impact analysis, to generate reports, and get an overview of how your requirements tie together.

Read the abbreviated transcript below or watch the recording to learn more about:

  • Best practices for requirements traceability in a modern solution
  • The easy and intuitive way you link your information in Jama Connect
  • How Jama Connect can be leveraged to help with impact analysis
  • Understanding suspects and traceability views

Martijn Jansson: When we talk about capturing data, we all know data in our organizations in different forms exist, so we have documents, and we have Excel sheets, and those Excel sheets contain rows and all those rows have the data around a certain requirement on a certain topic. Now, that’s all fine, but what we actually are after, what we really want from the system is information. Information gets created by building relationships and structure around those data assets in the system. When you do that, you basically empower your users and the ecosystem around you to find that information and to go along the relationship you build to get context on the data they are looking at.  

 Now, you can go a step higher with that, and that would be the top of the triangle is the knowledge part. The knowledge part means that you actually have to consider capturing the decision on the change you do on the information. We’ll touch you a little bit on that today, but that’s also in part a possibility in the Jama Connect.  

 The benefits of getting that information related, as I stated, you can trace those relations back to get to the source of where your data started, what was the first part that you actually started off from, what was the decision point, where did you start with capturing that requirement? Also, at a higher level, you can have an overview of what will happen when you change that specific part of information or piece of information. What will the ripple down effect be when I start changing that specific part?  

 And then on the learning part on the actual knowledge part, you want to capture the why of a change, so why did we change it? If you go back in time and you look at those changes, you can actually find back why you made the change and why you decided to, for instance, have a status changed or a requirement changed.  


RELATED: G2 Names Jama Connect® the Leader in Requirements Management Software


 And of course, you do not do that in your own ecosystem. You have many, many connections around you that have input on those decisions and have input on those connections, so engineering partners, customers, other departments within the company can be invited to take part in that process. We’ll take a look at that a little bit later on.  

 So, in the Jama Connect solution, we will take a look at the first part for data to information, so how do we actually relate information together and what is involved in building those relationships. And when I have them, what leverage, what value can and benefits can I get out of those relationships and what kind of overview do they give me? Now then, on the question part, we’ll take a little look as well on all the different areas where Jama Connect allows you to collaborate and to capture decisions and information on the changes you make during the process of building up your requirement.  

Why would we do all these exercises in the system? What is the underlying question? There’s a number of questions we get on a daily basis from our customers when it comes to traceability, so questions like, did we miss anything? Are we building a product that is still complying to what we originally set out to do? What was the original requirement? Where do we start off from? Do we have everything covered when it comes to the validation or the actual testing of parts? The embracing change is something that a lot of customers are on different levels when it comes to how they approach change, but when you look at change, and actually before you do the change, you can see what will happen if you do change that item and what will happen if you start editing the information you have at the top level or at a medium level, it gives you a lot more insight into what will happen and what will the impact be for the organization. So, change becomes a bit more, let’s say, easier to look at and to decide what you want to do.  

 Then lastly, the validation part is one I highlighted. When I have all these items and places, information and plans, how can I go back and say, “Okay, I have everything validated. I have everything verified. I’m compliant to standards internally or external standards or processes that we set out to comply to.”  

Watch the full webinar to learn more about best practices for requirements traceability.


 


Risk Management

In this post, we look at how Teledyne e2v leverages Jama Connect for improved communication and better risk management. 


Teledyne e2v is a global leader in specialized components and subsystems for innovative solutions in medical, science, aerospace, defense, and industrial applications.

  • Over 1600 employees in countries across Europe, America, and Asia.
  • As a result of their track record of innovation and technological breakthroughs, Teledyne e2v continues to be involved in many high-profile ground-breaking programs

Teledyne e2v’s success is built on long-established relationships with industry partners. The combination of their strong, in-house technical capability and links with technical authorities and universities, ensures that they can bring together the right level of expertise for a diverse range of technical challenges.

They offer:

  • RF Power solutions for defense, medical, marine, industrial, and security applications
  • Imaging solutions including CCD and CMOS sensors and cameras, for space and earth observation, life science, machine vision, and medical applications
  • Semiconductor solutions for aerospace and defense hi-rel microprocessors, high speed data converters, and high reliability ICs

A Single Source of Truth Increases Product Development Efficiencies and Improves the Flow of Information for Teledyne e2v

To meet the challenge of producing components and systems with increasing complexity, Teledyne e2v turned to the easy-to-use Jama Connect platform to provide a single source of information and end-to-end traceability for some of their product development teams.

OBJECTIVES

  • Optimize information flow
  • Improve formal review process
  • Find a product development tool that would garner broad adoption

After selecting Jama Connect, Teledyne e2v saw these results

Time-Saving Efficiencies in Meeting and Decision Making

With the single source of truth and real-time structured collaboration that Jama Connect provides, the Teledyne e2v team has streamlined the development process resulting in increased cross-team efficiencies and expedited decision making.

Streamlining and Simplification of Tools

After determining that Jama Connect was a sensible, easy-to-use, and easy to adopt tool that would increase efficiencies, having a customer saying they were going to use Jama simply sealed the deal and is helping Teledyne e2v achieve their goal of streamlining and simplifying their tools and processes.

Jama Connect has enabled a focused model of engineering leadership, with identified owners of top-level vision, and a streamlined, single source of truth. This has shown strong potential to leave developers with greater freedom to manage the detailed development and implementation in-line with the vision that is clearly communicated and controlled within Jama Connect. Leveraging this further across all projects and product developments is a key ambition for the team.

Driving Systems Thinking Across the Organization

Teledyne e2v’s leadership knows that tackling complex engineering problems and projects requires a structured and systematic approach. They needed a tool that would support their engineers and technical specialists to work in a structured way—without the tool getting in the way. Jama Connect enables this and is helping to drive systems engineering discipline further into the team, not only standardizing the way people work, but making it a positive experience.

To see how the team is now leveraging Jama Connect and how their risk management process has already improved, read the full customer story here.



What is requirements traceability

Product complexity is growing at an exponential rate. As it does, requirements move between more and more departments and stakeholders throughout the course of the development process. Requirements traceability helps product teams overcome one of the biggest challenges they face with requirements management.

The number of decision points is higher than it’s ever been. Each decision needs to be made understanding the impact on the requirement itself and on the product overall. It is essential to maintain visibility into the activity taking place and to be able to tie it all together.

That’s where requirements traceability comes in. What follows is a look at the definition of requirements traceability, as well as its purpose, importance, and benefits. You’ll also find common challenges of requirements traceability, along with a few ideas to help you start overcoming those obstacles today.


What is requirements traceability?

Requirements traceability is the tracking of requirements throughout the product development lifecycle. It is a documented thread that provides forward and backward visibility into all activity surrounding each requirement (including design, development, testing, and support). Requirements traceability helps minimize the risk of negative outcomes and maximize productivity. Its benefits include greater team efficiency, easier regulatory compliance, and higher-quality products.


Complex Upstream and Downstream Requirements Traceability

The purpose and importance of requirements traceability

Requirements traceability enables product teams to associate a specific requirement with all the related project artifacts, as well as other requirements, both forward and backward, so that anyone can see how the activity relates to the requirement—and vice versa—at any point during development. This functionality, also called live traceability, fosters team collaboration and enables early detection of possible production risks.

Think of it this way: How important is it to have your products developed correctly in terms of definition, quality, and timing? Mission critical, right? That’s why requirements traceability is so critical.

Let’s take a look at some of the benefits of requirements traceability throughout the product development lifecycle. For example, live traceability:

  • Simplifies project estimates
  • Enhances process visibility
  • Increases development efficiency
  • Improves impact analysis of change
  • Demonstrates verification and validation
  • Strengthens product quality
  • Proves compliance or functional safety

A single line of sight on a requirement, or a digital thread, is supremely important for application lifecycle management (ALM) and product lifecycle management (PLM). Both endure tight timelines and increasing numbers of requirements — including those from regulations, where compliance is non-negotiable.

Knowing the relationship between requirements, risk, tests, and so forth, is the difference between developing a compliant product on time and getting stuck in rework, delaying launches, and dealing with unhappy stakeholders. With requirements traceability, you don’t have to compromise on speed or quality.

The bottom line is that end-to-end traceability confirms you’re building the right thing and helps you prove compliance or functional safety. Without requirements traceability your development efficiency and product quality are in jeopardy.

Forward and backward traceability: The mechanics of creating a digital thread

To connect all the phases of the product development lifecycle, from customer needs through support, four distinct kinds of links must be used to thread the process end-to-end. This includes high-level requirements as well as derived requirements—those not specifically defined but necessary for meeting defined requirements or having the system work as expected. Derived requirements must also be adequately traced to reap the full benefits of live traceability.


RELATED POST: Building an Audit Trail Through Live Traceability

What is forward traceability?

There are two kinds of forward traceability: forward to requirements and forward from requirements. They both trace from an upstream component to downstream artifacts. The difference is in where they begin.

Forward to requirements traces from customer need to requirements. This is important because customer needs can evolve over time. If they do, requirements may need to change as a result. Following this type of forward traceability enables teams to be informed of changes in priorities at any time throughout development.

Forward from requirements traces relationships between requirements and corresponding downstream artifacts, including test cases. This type of trace ensures that each requirement is not only satisfied but verified and validated.

Backward Trace

What is backward traceability? 

Like forward traceability, there are two kinds of backward traceability. This pair traces from an endpoint, or downstream work product, to upstream elements. The two types of backward traceability have differing starting points.

Backward from requirements gives insight on how a requirement came to be by linking the requirement to the customer use case it addresses. This enables teams to improve decision making by understanding the origin of a requirement.

Backward to requirements begins at performed work and traces to its requirement. It gives visibility into why specific items were created and how different pieces of a system fit together. Tracing in this way also allows testers to find gaps or missing requirements.


RELATED POST: Checklist: Selecting a Requirements Management Tool

What is bidirectional traceability?

Bidirectional requirements traceability is the ability to perform both forward and backward traceability. Bidirectional traceability is the optimal type of traceability because it gives teams full visibility from requirements specifications through building, testing, changes, defects, and back again. Traceability of this caliber can only be achieved through automated requirements management tools, such as Jama Connect®.

Requirements Traceability Relationship Map

Common challenges of requirements traceability

If all this sounds like traceability is too difficult, fear not. While there are some challenges to requirements traceability, there are also many templates and tools you can use to streamline the process (more on that below). For now, let’s tackle some of the challenges so you can see how they can be overcome.

Differing organizational viewpoints.

Not everyone has the same understanding of why and how traceability should be performed. Stakeholders in sponsor or management positions may only view requirements traceability from a standard or regulatory perspective. They see it as a “must-have” but may not understand the additional benefits of requirements traceability (as discussed above) in the way a project or systems engineer might.

One way to tackle this obstacle is to educate stakeholders on what can be achieved if end-to-end traceability is achieved. Share this article with everyone involved in your development process so they can have a basic understanding of why requirements traceability is an essential part of requirements management, beyond simply knowing they need it to cover their bases.

Organization-wide adoption.

There are a variety of reasons a company might be slow to adopt traceability. Training is one such example. As considered regarding stakeholders, not all teams or individuals working on a project know why traceability is so crucial, or they simply may not know how to execute proper traceability correctly. Additionally, some people may be worried that traceability data from their decision points could come back to bite them.

If this is a challenge for your organization, again, education is imperative. But even beyond that, you need to create a culture in which traceability is seen as an inherent part of the development process. Start by creating clear policies regarding how the organization manages traceability. Then develop a positive training program for all new and existing employees to complete. If you choose a requirements management tool, make sure it has a strong track record of being intuitive and easy to use software that adapts to your process—not the other way around.


Want the inside scoop? See what users are saying about Jama Connect

Cost of implementation.

Getting an entire development organization on the same page regarding requirements traceability, then ensuring proper execution, can be a costly endeavor. The time spent developing policies, conducting training, and creating/maintaining traceability data add up and can even make folks feel less productive. Additionally, you may choose to adopt a traceability tool to streamline your process, which means upfront costs will be higher than previous projects.

Overcoming this obstacle requires a mindset change. We urge you to consider the cost of doing nothing. Unproductive work time, lengthy time-to-market, rework, and defects are all extremely expensive symptoms of inadequate requirements traceability. Each of these carries a hefty price tag. For a look at exactly how much these complications could be costing your organization, check out the calculators on pages 9-11 in our Buyer’s Guide. While there are costs to implementing requirements traceability and management tools, the amount saved throughout the development process far outweighs the short-term investment.

Managing change.

When building complex products, change is inevitable. It is essential that team members know about the changes and scope their impact across the product development lifecycle. That means looking closely at any related system requirements, downstream requirements, and verification tests that may be affected.

Performing this activity can be cumbersome and time consuming with manual requirements traceability tools. And the associated risks are similar to doing nothing, simply because you cannot be sure you’ve accounted for everything when dealing with static documents and human error.

If you’ve experienced this setback in your organization, it may be time to explore automated requirements management tools that enable live traceability with living requirements.


Jama Connect’s Requirements Management Enables Live Traceability™ Across Your Development Process

Bridge engineering siloes across development, test, and risk activities. Provide end-to-end compliance, risk mitigation, and process improvement with our intuitive, award-winning requirements management platform. Learn more! 


Improper management tools.

Some development teams are still tracing requirement relationships using Word or Excel documents and collaborating via email. A Requirements Traceability Matrix is one example of a document that manually traces elements of requirements management including, business requirements, objectives, design elements, and test cases via a spreadsheet. Teams input the list of requirements and fill in the related data. The spreadsheet is static but is updated manually by the team throughout the development lifecycle.

There can be advantages to using a Requirements Traceability Matrix if you are developing a product that doesn’t have many requirements. And it is better than not tracing at all. You can even use a template to create a Requirements Traceability Matrix. However, if your product is complex, with many requirements, you’ll likely experience many of the challenges discussed above.

In the case of complex products, a Requirements Traceability Matrix does not have the functionality you’ll need to keep up with the pace of change and create a quality product in the timeframe required by stakeholders. Flexible requirements management tools like Jama Connect can even capture trace relationships across teams and toolsets, further enhancing the benefits of traceability.

Insufficient compliance framework.

Regulated industries need requirements management to demonstrate compliance with industry standards. There are specific ways reviewers and regulators must receive regulatory submissions. To pass an audit you must present proof of comprehensive traceability.

If comprehensive traceability wasn’t performed throughout your development process, a lot of time will be committed to gathering the necessary information after the fact. Even if traceability was meticulously maintained in Word or Excel, there will still be time spent compiling it into an acceptable format for regulatory submission. In the meantime, competitors that make traceability inherent to their process will be first to market.

Sound familiar? Luckily, there are tools that perform end-to-end traceability and come with frameworks aligned with industry standards. Requirements management tools like Jama Connect simplify the audit process with export templates, thus speeding up the compliance presentation process.


RELATED POST: Requirements Management Tools and Software

Templates and tools to streamline the requirements traceability process

There are numerous tools available to assist with the requirements traceability process. It’s important to assess your needs to know what is best for you.

Are you creating a straightforward product that doesn’t have functional safety or regulatory requirements? If so, a Requirements Traceability Matrix may suffice. Download this Requirements Traceability Matrix template to get started today.

Are you creating a multifaceted product with both software and hardware components? Will you be required to prove functional safety or regulatory compliance? In these cases, you’ll need a requirements management tool with bidirectional traceability and compliance templates you can easily export.


Here’s some additional recommended content on traceability you might find helpful:


Traceability

No organization can thrive for nearly 70 years without evolving its processes, and Finnish Red Cross Blood Service (FRCBS) is no exception. The FRCBS’s Vein-to-Vein project is a prime example of how the organization has evolved to meet the digital age in order to provide the best care possible for those in need.

In 2016, FRCBS began to build the Vein-to-Vein system, a new information system for blood supply chain that covers blood donation and blood product manufacture, storage, and delivery to hospitals nationwide. Blood test results are also integrated into the information system. For the Vein-to-Vein information system project to be successful, data on blood products must work together seamlessly and the chain of data must remain unbroken, making the need for end-to-end traceability an incredibly important component.

This was one of many reasons the FRCBS began their search for a requirements and test management solution that could help them manage the complexity of the project. Their current test management solution, a pieced together system of Microsoft Excel and Microsoft Word documents, could not link risks and requirements to testing. Traceability was lacking, and the team knew the project’s success hinged on a solution that could clearly trace stakeholder requirements through testing, verification, and validation.

Like most organizations in 2020, FRCBS are working remotely throughout the country. Communication and collaboration were top priorities for the team. They knew that version control and review cycles would be compromised if they continued to use Excel and Word for their requirements and test management.

With the Vein-to-Vein information system, we are building the foundation for the digital future of the blood supply chain. It was abundantly clear to us that Word and Excel could not handle the amount of test cases and plans this project required.”

Susanna Pöhö Development Manager, Digital Services at FRCBS

Finnish Red Cross Blood Services Sees Improved Traceability, Communication, and Collaboration

In June of 2018 FRCBS began onboarding Jama Connect and with the help of CGI Finland — and Jama Software’s easy-to-use platform — they were up and running in 6 months. The FRCBS now uses Jama Connect for testing and risk management.

FRCBS estimates that the testing team has improved their communication and collaboration by 50%, and with the improved communication, the team estimates that their review cycles have been shortened by 80%.

“With Jama Connect, we can link high-level system requirements and risks and test cases. Jama Connect makes it possible to ensure the test cases cover the entire information system, and nothing is being overlooked.”

Susanna Majuri, System Specialist at FRCBS

Jama Connect has enabled improved end-to-end traceability and test management and allowed the teams to put more efficient processes in place. Because of Jama Connect, FRCBS estimates that the testing team has improved their communication and collaboration by 50%, and with the improved communication, the team estimates that their review cycles have been shortened by 80%.


RELATED: Your Guide to Selecting a Medical Device Development Platform


Audit Preparation Simplified and Shortened

While the system is not technically a CE-marked medical device, the Vein-to-Vein system must meet high quality standards, including GxP quality guidelines and other key regulations. Jama Connect has allowed them to easily demonstrate compliance in a digital format. The FRCBS team estimates that Jama Connect has helped reduce audit preparation time by more than 50%.

“Jama Connect plays a central role in our audit process. We’re able to easily show executed tests, and the whole hierarchy of high-level system requirements, risks, test cases, and scenarios,” said Pöhö.

Finnish Red Cross’ Digital Future with Jama Connect

As the Finnish Red Cross organization continues its efforts to digitize development projects, FRCBS sets a great example with their implementation of Jama Connect.

“We implemented Jama Connect in the middle of large-scale information system project. Our only regret is that we didn’t implement it sooner in the project so we could leverage Jama Connect’s full capabilities,” said Pöhö. “In the future, it will be easier once we widen the range of usage across the organization.” “We’d like to broaden our use of Jama Connect across the company, especially for testing and validation. It’s a new, modern way of working that’s improved our processes immensely,” said Pöhö.


To see more information about the importance of traceability in complex product development, we’ve compiled a handy list of valuable resources for you!

SEE MORE RESOURCES

end-to-end traceability

Traceability is the ability to track upstream and downstream relationships between requirements and other artifacts, ranging from test cases to higher-level system or subsystem requirements. Through end-to-end traceability, teams can see if a product’s development process is currently on track, as well as view any and all of the history and context associated with it.

That’s the ideal, at least.

Where Traceability Can Come Up Short – And How to Fix It

Traditionally, traceability has been performed using document-based workflows involving applications such as Microsoft Word and Excel. A team member creates a traceability matrix in a text document or spreadsheet and updates it manually throughout the product development lifecycle. Unfortunately, this approach has distinct limitations and is prone to error.

When teams trace requirements within discrete and static documents, they often create extra work for themselves, while also running the risk of missing out on critical updates or making mistakes.

Let’s say someone updates a matrix in Excel with the latest statuses of test cases related to a medical device that’s in development. It might seem like everything is proceeding smoothly on the surface, but multiple problems could be lurking underneath:

Human Error

Since everything is done by hand, this individual must regularly revisit the matrix to keep it in sync and up to date with product development activities across the whole organization. The complexity of the traceability matrix in question – with its numerous tables showing how requirements and test cases connect to one another – makes such work inherently complicated and error-prone.

Email-Centric Collaboration

Meanwhile, these updates to the matrix are primarily communicated via email. Between the normal flow of messages into everyone’s inboxes, people being out of the office, and other complications -like poor version control – and mishandling of incorporating everyone’s comments, it is likely that errors will occur and misunderstanding will necessitate rework down the line.

No Built-In Compliance

Finally, even if everything goes according to plan, there’s no guarantee that the traceability workflows in use will account for all relevant requirements and risks. For instance, in the case of a medical device, a matrix created within Excel won’t come with frameworks aligned with industry standards like ISO 14971, making it more difficult to ensure coordinated traceability and ensure successful proof of compliance.

Fortunately, these types of issues don’t have to hold your teams back and expose your product development processes to undue risk. End-to-end traceability is possible by upgrading from document-oriented workflows to a comprehensive requirements management platform that enables real-time collaboration, bidirectional traceability, and integrated risk management.

Let’s look at four central benefits of implementing end-to-end traceability with a solution like Jama Connect®.

1. Holistic, Actionable Visibility into Requirements and Stakeholders

Traceability is ultimately about relationships, not just between requirements and other artifacts, but between all of those items and the people responsible for managing them. With end-to-end traceability in place, teams can see:

  • How requirements trace forward to their implementations within work products, along with how those products trace back to original requirements and designs.
  • How all requirements were tested – i.e., the test cases linked to them, whether the tests passed or failed, and any associated defects identified along the way.
  • Who was involved in the development of specific requirements and test runs, so that they can be notified right away about necessary next steps or actions required.

This comprehensive visibility creates a system of action – one that teams can use to not only trace the life of each artifact but to initiate the appropriate activities to sustain product development and ensure coverage. Is a medical device safe to use? Does it comply with applicable standards? Can the processes used for building it stand up under an audit? A full-fledged traceability solution provides clear answers to these questions and others.

2. Better Impact Analysis of Changes

Truly informed impact analysis isn’t possible without end-to-end traceability. That’s because such analysis is rooted in being able to see how specific changes to an artifact will affect other items connected to it. Knowing those impacts requires traceability.

In traditional document-based workflows, it can be difficult to know how different items are affected by change. But in a platform with end-to-end traceability, much of this work is automated and becomes a byproduct of your daily work. The solution will instantly flag downstream links as “suspect” so that teams can attend to them as needed.

For example, teams can see if an altered requirement has test cases downstream and what share of them have passed – all in real time. This setup saves immense time and effort compared to manual processes.


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3. Easier Identification of Gaps in Test Coverage

Speaking of tests, a requirement is typically only considered “covered” if it has corresponding test cases against it, as well as test engineers assigned to it. But too often, gaps in coverage only become apparent after the fact, when a product issue reveals how a key flaw was overlooked during development.

In fields with rapid change and innovation, such as medical device development and automotive manufacturing, any unidentified coverage gaps are risky to end users and costly to remediate. Improved tracking of test coverage in a platform with end-to-end traceability helps eliminate these blind spots and ensure quality.

More specifically, this level of traceability within a requirements management solution helps test engineers and project managers visualize where gaps exist and whether tests have been approved, completed, rejected, or drafted. As a result, product development becomes less risky overall.

4. Simplified, More Accurate Audit Passage

“Show your work” is a familiar adage to anyone who’s completed a mathematics assignment, and it is crucial advice when tracing requirements, too. Passing an audit will require presenting specific information about those requirements, in formats acceptable to reviewers and regulators.

A platform like Jama Connect simplifies this process by letting teams show clear supporting evidence of comprehensive traceability. It provides export templates like trace reports to provide this evidence, simplifying regulatory submissions and the audit process.

Jama Connect’s Requirements Management Enables Live Traceability™ Across Your Development Process.

Bridge engineering siloes across development, test, and risk activities. Provide end-to-end compliance, risk mitigation, and process improvement with our intuitive, award-winning requirements management platform. Learn more! 


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