Tag Archive for: traceability Page 6

Tag Archive for: traceability

Traceability

Editor’s Note: This post about how traceability improves collaboration and decision making was originally published here on DevOps.com on September 23rd, 2020, and was written by Josh Turpen, Jama Software’s Chief Product Officer. 

Jama Connect® creates Live Traceability™ through siloed development, test, and risk activities. Provide end-to-end compliance, risk mitigation, and process improvement with our intuitive, award-winning platform.

Minimize the risk of delays, defects, cost overruns, and the manual effort created by fragmented development processes and legacy solutions. Learn more!

New software is being developed at an incredible pace to help make our lives easier. This doesn’t change the fact that humans are still held accountable for product development decisions, whether these are made with or without advanced analysis tools. To make informed choices, product development professionals need tools that allow them to see comprehensible information in real-time as change is happening, both within the team’s structure and throughout the system in which their product exists.

Modern traceability makes it possible to both manage and respond to change in a systematic, auditable and confidence-enhancing way. Below, we will discuss three ways traceability has evolved to support key decision-makers in a number of industries.

Modern traceability captures when you make a decision

Decisions often have varying levels of durability. Sometimes, when you make a decision, you know then and there it’s final. Other times, you make what seems to be a minor choice and you end up dealing with the repercussions for years to come. With this level of uncertainty, it is essential to have mechanisms that allow you to see when decisions are made. As I discussed in a previous article, “5 Ways Traceability is Changing to Bolster the Remote Workforce,” this process can be compared to a map. By leading a team through every step of their processes, modern traceability helps product developers reach their goals without any surprises.

Often, products are expected to be maintained for years. This is significantly more challenging when you can’t properly track where a ruling originated or a change was made. While the team may move quickly in the development process, the record should always live on to provide future context where it’s needed.

RELATED POST: How to Realign Engineering Teams for Remote Work with Minimal Disruption

Modern traceability provides people the context of what they’re working on as they go, not after the fact

Rather than rely on sharing often lengthy and disparate documents or running time-consuming general meetings, traceability allows teams to streamline their collaboration. Mapping out work items, including owners and contributors, gives people a reason to care and to trace those items carefully. It helps everyone know why they’re there, what they are discussing and how to address it.

Many smaller companies are fortunate to get by using Word documents and other legacy tools for their traceability measures. However, as these companies grow, so do the complexities. That’s why traceability has been evolving to account for the multi-dimensional nature of requirement, test and risk management. For a company that is seeing major growth to be truly successful, all related variables must work together continuously, at scale and across teams. Legacy tools simply do not provide the agile capabilities that modern traceability does.

RELATED POST: Requirements Traceability – How To Go Live

Traceability captures and tracks past decisions and allows users to access them

Traceability is all about relationships. Each product in development has its own particular set of customers, stakeholders and internal team members associated with it. Therefore, traceability is only possible if these individuals can be accurately connected to the items for which they are responsible.

Knowing who made a decision and what information they accessed is equally as important as the information itself. If you can’t quickly piece that together, your traceability is incomplete. The responsible thing to do is to ease the process by keeping useful records. It doesn’t need to be forced behavior if it’s captured along the way as a byproduct of doing your job.

Overall, accountability is incomplete and past decisions can’t easily be seen, learned from or built upon without robust, modern traceability tools. It’s much harder to legitimately hold someone accountable when they’re working in the dark. However, when done correctly, traceability can be used as a key tool to support genuine liability and allow for a streamlined process of complex decision-making.

Download our eBook to learn how optimize product development with strategic team collaboration.

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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.

RELATED POST: What is Requirements Traceability and Why Does It Matter for Product Teams

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! 

Download our eBook to learn how to optimize product development with strategic team collaboration.

DOWNLOAD NOW


Impact AnalysisImpact analysis is the assessment of the implications of changes, in the specific context of product development. It is integral to requirements management, as it offers insights into dependencies and gaps in coverage, which help inform decisions about the product’s lifecycle.

Let’s say an organization is developing a medical device and must change some of its requirements along the way – something that happens all the time. By conducting an impact analysis of this requirement and its dependencies, the product development team could accomplish all of the following:

  • Determine the ripple effects of the change: How will it affect higher-level requirements upstream and links downstream? Are there are any conflicts to resolve? Proper impact analysis answers these questions and in turn reduces the risk of unexpected consequences requiring costly remediation later on in the lifecycle.
  • Connect people, not just requirements: The impact analysis process should go beyond flagging at-risk upstream and downstream items. It should also reveal who is affected by changes, plus notify those team members about the necessary next steps. This is where live traceability and real-time collaboration in one platform really matter.
  • Assess what is required going forward: Impact analysis is ultimately about gaining visibility into the future – almost like a crystal ball – and acting accordingly. In addition to showing potential risks to existing requirements, it can also identify new requirements and test cases that may be needed for keeping the project on track.

Teams may perform impact analysis using multiple tools. A dedicated requirements management platform, with integrated risk management and end-to-end traceability, is ideal for fully mapping out the effects of changes and identifying subsequent action items, along with the personnel responsible for them.  When manual tools are used, data gets kept in silos which can create misalignment, poor visibility, and difficulty to assess the impact of change.

Replacing those manual workflows, which often revolve around software like Microsoft Word and Excel, is crucial for optimizing impact analysis. That’s because informed analysis requires accurate traceability, something made much easier with a proactive and automated platform that serves as a single source of truth at every stage of product development. In this way, requirements management software addresses the biggest roadblocks to effective impact analysis.

Overcoming the Obstacles en Route to Better Impact Analysis

From the rapid pace of innovation in industries like medical device development and automotive manufacturing, to the need to coordinate increasingly distributed and remote engineering teams, there is no shortage of possible challenges when building a complex, modern product. When it comes to impact analysis in particular, the three primary issues include:

1. Manual Traceability

Impact analysis isn’t possible without effective traceability. But with so many evolving requirements to keep track of, accurately tracing everything can be difficult without truly scalable and automated tools.

To see why, consider a hypothetical case in which a critical requirement needs an immediate change. The time constraints mean all upstream and downstream effects must be quickly accounted for, with requirements and other artifacts (like test cases) properly traced forward and/or backward as needed.

But doing so is difficult when working with nothing more than a traditional traceability matrix  housed in Excel or Word. The amount of manual work required could result in something being missed due to human error and a lack of comprehensive traceability within the matrix itself. The team might not realize they’ve overlooked missing coverage until it’s too late.

Solution: Live traceability provides straightforward navigation of upstream and downstream relationships, along with automatic identification of risky links. It also updates items in real time so that team members are always looking at the most accurate assessment of test coverage.

2. Inefficient Modes of Collaboration

Email-oriented collaboration only compounds the above problem. When lengthy, complex documents – which might not even be up to date – are emailed between teams, confusion, and delay are almost inevitable.

Simply staying current with any changes to project requirements can mean searching through your crowded inbox and trying to reconcile various attachments. Is “RequirementsDoc_v2FINAL” really the final version, or is there something more recent circulating under a different name?

In order to effectively conduct impact analysis, everyone tied to the requirements needs to be notified in real-time when changes are made and provide their input. Centralizing this information creates a more systematic way for change management and enables accountability within the organization on how decisions are made past and present.

Solution: Instead of email, use a real-time platform with instant notifications and the ability to pull in internal and external collaborators as needed. On such a platform, everyone is looking at the same data, which helps expedite review and approvals.

3. Rework and Opportunity Costs

Impact analysis is supposed to reduce risk by letting you see how specific changes will play out and empowering you to take any corrective action as early as possible. But when impact analysis is built upon manual processes and limited traceability, it can do the opposite and actually make projects riskier.

For example, extensive rework may be required to ensure that all requirements are met. This work represents a major opportunity cost, as the time sunk into correcting process-related problems could have gone into more strategic initiatives.

However, teams can avoid getting bogged down in rework by upgrading their impact analysis and traceability tools. Leaving static documents behind for an automated platform with real-time collaboration built-in is both reliable and helps to ensure product quality.

Solution: Invest in a platform that enables proactive, rather than reactive, requirements management. Features like live traceability that connect requirements to tests make it easier to handle changes as they happen and avoid costlier actions later on.

Fueling the Engine for Superior Impact Analysis

A modern requirements management platform enables streamlined impact analysis while bringing teams closer together to work in real-time, even if they’re physically distributed. As a result, analyzing upstream and downstream relationships becomes more practical, as does the overall development of high-quality products within budget and on time.

More specifically, the right solution will be an engine for better impact analysis, propelling key advantages throughout product development, including:

  • Automatic identification of suspect links: If a requirement is modified, the platform will automatically flag its downstream links as “suspect” so that team members can review them before proceeding with development.
  • Easier relationship navigation: Users can efficiently navigate upstream and downstream relationships. A visual schematic lets team members save time in finding missing coverage and make sure that they’re not overlooking anything.
  • Enhanced collaboration: Team members get notified about relevant changes and can be pulled in right away to respond, on a shared platform offering a single source of truth. This real-time setup is much more efficient than relying on email alone.
Want to learn more about how Jama Connect can improve your impact analysis? Set up a free trial today to get started.

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Remote Workforce

Editor’s Note: This post on ways traceability has changed to support the remote workforce was originally published here on DevOps.com on June 24th, 2020, and was written by Josh Turpen, Chief Product Officer at Jama Software.

Traceability has always been a useful tool in the development process, but it has become especially important since the COVID-19 outbreak and the increased remote workforce.

Where developers and engineers were once working side-by-side, with the ability to discuss their process and keep their team informed, they are now navigating a remote collaboration landscape. According to a 2017 study done by Stack Overflow, there is a correlation for developers between remote work and job satisfaction, and the highest job satisfaction ratings are seen from developers who work remote full time. As technology has grown to make this process easier, remote working is expected to become a norm.

Advanced traceability has the potential to hold teams together by allowing increased visibility into each move throughout an entire project. Without traceability, it would be nearly impossible to keep remote teams aligned and on schedule.

Product development tools have continuously been forced to evolve to keep up with the multi-dimensional nature of requirement, test and risk management. For these processes to be successful, all related variables must work together continuously, at scale, and across teams.

We’ve only just started to see how traceability tools can use updated capabilities to streamline the product development process, but we know enough to discuss two things: what’s happening now and what the future may hold.

RELATED POST: Requirements Traceability – How To Go Live

Traditionally, traceability could be compared to a map. While not limited to a single view, maps exist to help you navigate your way to a destination. Similarly, traceability leads product developers through every step of their processes, eventually helping them reach their goal. If your map was constantly changing you’d never be able to figure out where you were going, but what if people ahead of you could update it as they went along? This would keep you in the loop of the upcoming twists and turns, and no one would feel blindsided. Traceability makes it easy to share similar production changes with your entire team, all at once.

In the traceability process, links are built automatically which lets major decision points, reviews and approvals be captured in final documents and reports. This allows for faster and more informed decision making and these live references can exist across versions.

With the switch to remote work across the globe, and no immediate end in sight, developers don’t have the option of working side-by-side with their colleagues. Because of this, it is pertinent that they are able to streamline their work in every way possible, and increased traceability is expected to be a pillar of that transition.

At the end of the day, connecting the dots is all about making sense of everyone’s decisions. Why did they follow that process, and what factors led them to make the choices they made?

In the early days of traceability there wasn’t always room to include every piece of information that you might find relevant down the line. Legacy tools such as the act of manual reporting through Word documents left much to be desired. Today, that’s becoming less of an issue, as developers are allowed more meaningful accountability and insight into interconnections as they happen.

As we look ahead, we can expect to see these capabilities grow in five different ways.

RELATED POST: Building An Audit Trail Through Live Traceability

Less Manual Effort

Updating your traceability reports with as little manual effort as possible will be essential to a streamlined, remote workforce. As traceability becomes more advanced, the work to create and maintain it should not become more difficult.

More Nuance Captured, Related and Parsed for Meaning

Improvements in software will make data gathering more precise, and increase the number of items a team can consider relevant, traceable information. This will take additional workloads off of the developers as more items are automatically traced and easily accessible.

More Attributes Can Define and Predict a Project’s Success

If you have a more data-rich, detailed record of activities, it is possible to understand the past with more context and less reliance on costly manual documentation or memory.

Dispersed Systems Holding Relevant Information Will Start to Feel Closer and More Interconnected

Through more dense integration and aligned processes, systems feel more controlled and connected, giving users a more seamless experience.

Expansion of Communication and Review Capabilities for Stakeholders Who May Be Impacted by Changes

The availability of a full audit trail of participation will make a big difference in the ease of the review process. The ability to easily see who is impacted by changes will allow teams to proactively manage the effects of said changes.

In response to the COVID-19 pandemic, and the number of companies who are maintaining their remote work policies, we can expect to see more innovations related to product development workflows. These innovations will enable easier remote collaboration between colleagues and across teams, overall streamlining the product development 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! 

Want more best practices and tips? Watch a recording of our webinar, “Ask Jama: Best Practices for Remote Collaboration with Jama Connect.”

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Jama Deminar SeriesWith over 12.5 million active users, organizations around the globe rely on Jama Connect to help bring complex products to life. Innovative companies choose Jama Connect to improve quality, reduce rework, prove compliance, and get to market faster.

That’s why we’re excited to announce a six-part series of deminars (yes, you read that right – it’s a demonstration webinar!) where we’ll be giving you an inside look at the leading platform for requirements, risk, and test management. In this deminar series, we’ll cover key features and capabilities, seamless integrations, best practices, and more.

Below is a snapshot of when each deminar will happen, what will be covered, and how you can save your spot.

Product Essentials: A Quick Tour of Jama Connect for Modern Requirements Management

Thursday, September 10 – 8:00 a.m. PT | 17:00 CEST

Jama Connect enables consistency, collaboration, and alignment across the enterprise by providing a continuous flow of accurate requirements information. This webinar demonstration tour provides an overview of the Jama Connect platform.

In this demonstration session, you’ll learn how to:

    • Establish alignment across people, process, and technology to establish a single source of truth around digital requirements management
    • Collaborate across both internal and external teams using Review Center
    • Use traceability views to provide visibility across the entire product development cycle
    • Utilize our common integrations to extend the solution capabilities — including JIRA
    • Use Jama Connect to support testing, change management and impact analysis

Product Essentials: How to Streamline Reviews and Collaborate with Remote Teams, Customers, and Suppliers with Jama Connect.   

Thursday, September 24 – 8:00 a.m. PT | 17:00 CEST

Through structured collaboration in Jama connect, teams can source feedback from distributed teams and collect side-conversations in an actionable way to gain cross-team visibility.

In this demonstration session, you’ll learn how to:

  • Easily establish communication and document decisions across virtual teams
  • Immediately notify and prioritize critical decisions and pull in required contributors throughout the development process
  • Hold formal reviews and document those decisions in Review Center
  • Exchange requirements with remote teams, customers, and suppliers to extend the development process beyond your core team

REGISTER NOW

Product Essentials: Unpacking Requirements Traceability Capabilities of Jama Connect

Thursday, October 8 – 8:00 a.m. PT | 17:00 CEST

In this session you’ll learn how Jama Connect capabilities provide requirements traceability which improves product development accuracy and/or quality and ensures the ability to provide trace reports for audits. Learn how various options are used to track relationships to/from/between requirements and understand the full impact across the project.

In this demonstration session, you’ll learn how to:

  • Create relationship guardrails to ensure traceability rules will guide users and prevent dependency chaos
  • Right click to build relationship dependencies as you perform everyday work activities
  • Use trace view to:
    • Identify relationship dependencies between data
    • Track progress and identify missing work items
    • Analyze potential impact of changes
    • Gain visibility needed for prioritizing lower level work items against higher level requirements
  • Use item widgets to:
    • View impact analysis to understand the potential impact of change
    • Initiate conversations between connected users
    • Export relationship dependencies to support compliance audits

REGISTER NOW

Product Essentials: Using Jama Connect and JIRA to Manage Requirements for Software Development Teams

Thursday, October 22 – 8:00 a.m. PT | 17:00 CEST

In this session you’ll learn how Jama Connect provides the ability to link JIRA tasks and defects to requirements for full transparency, traceability, and change management throughout the software development process. Product and engineering teams can connect product planning to execution and stay in sync to ensure accuracy and quality of work.

In this demonstration session, you’ll learn how:

  • Link issues and defects from JIRA to Jama Connect
  • Support conversations across the team between the requirements and epics throughout the software development process
  • Analyze—at a dashboard level—the state of the tests, stories, and epics related to a project
  • Use the two-way integration between Jama and JIRA to allow the flow of information back and forth across the teams with synchronization, providing a single source repository and full traceability

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Product Essentials: Sharing How Jama Connect Allows for Earlier Testing in the Lifecycle to Increase Quality and Efficiency.

Thursday, November 5 – 8:00 a.m. PT | 17:00 CET

Through testing in Jama connect, teams can achieve value by incorporating the results of the test strategy into the product strategy and identify potential defects earlier in the product development lifecycle, which prevents late stage changes leading to costly rework.  Learn how Jama Connect provides full manual testing capabilities tied into the product development process ensuring that you release a best-quality product that meets customer expectations.

In this demonstration session, you’ll learn how to:

  • Create a test case and configure filters to quickly access requirements that have no test coverage
  • View test cases, the tests associated, and test run results to analyze test coverage and easily view any gaps
  • Log defects from the testing interface and view automatic trace relationships
  • Export reports to support compliance activities

REGISTER NOW

Product Essentials: Working with baselines in Jama Connect to Facilitate Compliance and Reuse in Product Development.

Thursday, November 19 – 8:00 a.m. PT | 17:00 CET

Learn how to view and create a baseline to capture and preserve the project at a single point in time. This supports compliance and enables reuse in product development projects.

In this demonstration session, you’ll learn how to:

  • Coordinate product releases across teams and projects
  • Easily create a baseline release and track it effectively throughout the development of the product
  • Navigate the workflow across teams to support release schedules
  • Use baselines to fulfill regulatory requirements (with respect to record keeping) by producing a clear and readable audit trail.

REGISTER NOW

To view the full series, watch recordings of the deminars after they happen, or register for individual deminars, visit our Product Essentials page.

SEE ALL DEMINARS

Product Development Lifecycle Management

Product development lifecycle management is the handling of the entire lifecycle of a product, from its earliest stages of concept development to its eventual production and use in the market. Effective strategy and execution across the lifecycle requires preserving quality while working within constraints on cost and time. A key component to successful product development is managing your requirements from start to finish within a system that allows for complete traceability and collaboration throughout the development process. A requirements management solution that enables live traceability, real-time collaboration, flexible development methodologies and hierarchical organization will ultimately lead to an improved product development lifecycle.

The Importance of Live Traceability

From the early stages of a product’s development all the way through its go-to-market execution, product development teams need to understand how their different requirements and tests are traced to each other throughout the process, in order to effectively manage compliance, track changes, and ensure product quality. The right solution should enable visibility across the product development lifecycle, so that team members can:

  • See the impact of change before it happens and adjust as needed
  • Automatically trace your requirements as you create content, reducing non-value time
  • Keep track of test coverage one convenient place
  • Automatically have guardrails that alert you to any gaps in your product development
  • Easily view and navigate upstream and downstream relationships
  • Create a clear audit trail to support the development of complex, safety-driven products
  • Export your trace matrices easily to help with proof of compliance

So how do these types of features work in practice? Let’s examine how live traceability functions in specific ways within Jama Connect.

Navigating Change Management and Impact Analysis

Too often data in complex product development remains in siloes, creating misalignment, lack of visibility, and difficulty to assess the impact of change. With objects traced in Jama Connect, you have the ability to perform an impact analysis which enables you to review the impact of each change to a new or existing product before it’s actually made. Changes happen to requirements and other artifacts all the time, which is why it’s important to be able to create baselines.

Additionally, the platform can reactively and automatically mark items as “suspect” when they are downstream from a modified item. Teams can then review a running listing of items needing further evaluation that may need to be evaluated for impact.

Relationship rules also enable you to track items within the same project or across multiple projects, using a visual schematic for representing the different artifacts traced throughout your development process.

Jama Connect can take a snapshot that documents the detailed status of a project, or any subset of a project, at a designated point in time, also allowing you to maintain meaningful comparison and overall traceability.

Multiple versions of a product requirement can also be compared, side-by-side, to see what changed. Through such visualization, teams can easily see how requirements have iterated over time and what led to those changes.

Diving into Test Management and Traceability

QA teams need the power to trace test results back to their corresponding requirements. In Jama Connect, these teams can perform manual testing, create and organize test plans with groups of test cases, dashboards, and view test-related reports throughout the product development process. They can also:

  • Organize testing information to support an iterative verification process
  • Identify missing test coverage and take action to close gaps
  • Reuse validated requirements saving time when testing across multiple product versions or variants.
  • View real-time, consolidated data about test plans, associated test cycles, cases, and test runs to-date
  • Perform all of these actions from the same interface

The end result is reduced risk throughout the product development lifecycle, along with increased product quality. For example, the ability to log failures and defects allows for the creation of trace relationships that make it easier to resolve the issue in question.

Meanwhile, out of the box reports and dashboards provide straightforward visualizations of the progress of the test management process, including how tests trace back to their requirements. That helps simplify industry compliance, as it is easy to show auditors  the connections between requirements and tests along with associated results.

RELATED: Five Tips for Requirements Traceability

Adding Power Through Integrations

An RM, test, and risk platform ensures that no project-related stone is left unturned, not only through the test management capabilities above, but also through wide-reaching integrations.

In Jama Connect, you can integrate with industry leading solutions providing a flexible, scalable solution when automated testing is necessary in the product development lifecycle. Pull in automated test results from other sources using Jama Connect’s integrations with popular solutions such as Tricentis: qTest, LDRA, Vector, Testrail, and ANSYS, as well as its Open REST API.

The Role of Real-Time Collaboration

The product development lifecycle requires collaboration between multiple stakeholders and teams, along with the efficient capture of stakeholder feedback and other standardized data during the requirements review and approval processes. Teams must be able to share, confirm, and iterate on product requirements and specifications, determine acceptance criteria, and coordinate engineering responses in real time, including prioritization capturing electronic signatures for approvals – ideally from a common place.

In reality, real-time collaboration is hindered by disjointed processes and discrete documents.

Review Center within Jama Connect provides a streamlined alternative, allowing you to gather and incorporate feedback from the relevant project stakeholders, track a review’s overall progress and view team statistics to determine which requirements have the most issues to address.

Managing Approvals and Electronic Signatures

Reviewers can join in conversations and mark items as “Approved” or “Needs More Work.” Use electronic signatures to demarcate the different stages of the product development process, establish roles between “Reviewers” and “Approvers” and export approved reviews to more effectively prove compliance. Each signature captures the time and date for auditing purposes, making it very straightforward to tie them back to their corresponding individuals or stakeholders.

Effective collaboration and engagement throughout the product development lifecycle has numerous benefits. With the right platform and setup, you can shorten milestone phases and development cycles, help teams better identify risks and opportunities and improve overall time to market.

RELATED: Streamlining Requirements Reviews: Best Practices for Moderators, Reviewers, and Approvers

Stream Discussions and Assign Responsibility

Jama Connect allows you to stream discussions bringing both internal and external stakeholders into the conversation easily without needing to navigate deep into the requirements management platform. A conversation can be easily expanded to encompass the necessary users and stakeholders and communicate key actions items to them. A user can respond to a conversation without even accessing the application proper, allowing them to add to a threaded and contextual exchange with ease.

Along similar lines, Jama Connect helps you see who authored, edited, commented on, or was mentioned in any given item. These details allow for quicker, more targeted action, for instance if a requirement changed and needs to be updated right away. The responsible parties, whether a developer or QA lead, can be notified and supplied with the relevant context.

Reusing Requirements to Save Time and Increase Consistency

Products often share requirements, so why not reuse them once approved? Efficient reuse requires the right platform for cataloging all the specific requirements in question and keeping them in sync across the organization.

Traditional document-based product development lifecycle management is an obstacle to reuse. Adding in a modern platform is a good step toward greater consistency in how you reuse your requirements and in turn shorten time-to-market by eliminating rework and manual processes.

To learn more on the topic of requirements management, we’ve curated some of our best resources for you here.

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This post is the first in a three-part series on traceability. Keep an eye out for the second two posts on how requirements traceability will be different in the 2020s, and lessons learned from 2010s Agile product development.

There are new software capabilities being developed every day keeping us dazzled with trend-driven analytics and massive data analysis. At the end of the day though, it’s humans that are still accountable for the product development decisions being made with or without cutting-edge analysis tools. Even with the advancement of automated analytics, decision-makers must still demand good information so they can truly own their choices in complex product development.

Making good decisions depends on the ability to see comprehensible information as change happens in real time, both within your team and throughout the system your product exists in. That’s where modern traceability comes in – it makes it possible to manage and respond to change in a systematic, auditable, confidence-enhancing way.

Rather than trying to prevent change (still impossible with our current technology for now…), here are three ways traceability has evolved to support the dynamic job of decision makers.

Evolution 1: Modern traceability can capture when you actually make a decision, in multiple formats from both formal and informal situations.

Decisions have varying levels of durability, and it’s not always obvious at the time what that level is. Sometimes you know at the time you’re making a final, consequential decision. Other times you make what you think is a temporary choice and you’re living with it 5-10+ years later. Given that uncertainty, having mechanisms to see when decisions are made (throughout the development process) is essential when products are expected to be maintained for years. We may need to move on quickly in the development process, but the record can live on for future context.

In Action: Formal decision processes such as gate reviews can be managed in tools like Jama Connect™ Review Center, making it easier to mark versions of requirements as signed-off and complete. Decisions that arise from less formal activities like comment threads on requirements can be tagged and referenced later to piece together thinking from the past.

Electronically sign-off on formal reviews using Jama Connect Review Center.

“Catching these traceability gaps would’ve probably taken hours or days in our old system, while with Jama, it became obvious in a matter of minutes.” Read how Jama Connect improved Össur’s traceability process.

Evolution 2: Modern traceability connects people to the context of what they’re working on as they go – not just globally or in a matrix after the fact.

Traceability gives people a (specific) reason to care when asking for input. It helps everyone know why they’re there. Rather than rely on sharing lengthy Word documents or running general meetings, precise outreach is possible with precise mapping of work items (including their owners and contributors) to each other.

In Action: Figure out who to direct questions to or notify by looking at interconnected people, not just the work items. This list can be automatically generated with Jama Connect’s connected users feature – so knowing who to contact won’t slow anyone down from having timely conversations.

See who’s related to each item with connected users.

 

Evolution 3: Traceability can show past decisions, because they’ve been captured all along.

Can you follow any thread of a question or item to how it got there and why? Knowing who made a decision, and what information *they* had access to is as important as the information itself. Your traceability is incomplete if you can’t piece that together. The faster the better. The responsible thing to do: Make the task of keeping useful records low friction. It doesn’t need to be forced behavior if it’s captured along the way as a biproduct of doing your job.

In Action: Building technical requirements directly from primary source materials, like high level market requirements, has multiple benefits. It simplifies the authoring process by having the downstream requirements writing right next to the source materials, so the translation step is that much easier. It also ensures that when something changes downstream, features like Jama Connect’s suspect links can show where those changes impact other work in real time – no need to wait for an event to reconcile the original goals with what was built.

View the context of how decisions were made with commenting in single-item view.

Traceability can be used to support more genuine accountability. Without robust, modern traceability tools accountability is incomplete — past decisions can’t easily be seen, learned from, or built upon when new choices are made. It’s much harder to legitimately hold someone accountable when they’re working in the dark.

To go deeper on the topic of traceability, and how Jama Connect helps fast track the process, check out our eBook, “The Jama Software Guide to Requirements Traceability.”

Ossur uses Jama for Medical Device Development

In medical device development, control of quality and risk is heavily driven by regulatory requirements. Compliance with international medical device standards like ISO 13485 and ISO 14971 can drain resources and reduce operational agility if the means of demonstrating compliance are not agile themselves.

The more complex the project, the higher the risk. And the higher the risk, the more stringent the medical device compliance procedures. Managing hundreds of requirements in a document-based system without traceability becomes a major chore.

Össur, a global leader in non-invasive orthopedics, had for several years been relying on an internally developed document-based process to manage its product requirements. While their system had been working as intended, they felt there was an opportunity to streamline procedures and compliance tasks.

The Costs of a Rigid Requirements System in Medical Device Development

Continually evolving its processes has always been a key to success for Össur, whose cutting-edge prosthetics technologies have been showcased in publications like Popular Science and have been worn in competition in the Olympic Games. They examined their development cycle for inefficiencies and noted their requirements process unfolded in a sequential manner that was costing them an enormous amount of time and effort.

In specifying a highly complex Össur medical device, several engineers would collaborate on drafting requirements and compiling the requirements document. The document would then be circulated for review. Once approved, the requirements would be verified. If any requirement needed to be added or changed, however, the entire review and approval cycle had to be repeated.

“Our old system was very rigid,” said David Langlois, Director of R&D for Bionic Solutions at Össur. “The minimum effort was always quite high, which means the overhead was also high.”

Össur knew it was time for a change. They wanted something that was as close to a turn-key solution as possible — one that would provide traceability and dynamic content management, and would be scalable across their organization. Plus, it needed to be capable of handling the complete development chain — from requirements through verification and validation, along with easing the path to compliance to ISO standards like ISO 13485 and ISO 14971 — for a diverse product line.

After evaluating several alternatives, including some designed specifically for medical device development, Össur chose Jama Connect™.

 Learn more about how Jama Connect helps teams improve medical device development.

Replacing Process Rigidity with Speed and Agility

Össur began using Jama Connect in 2018, starting with a small group of developers working on bionic lower-limb prosthetics. They immediately began seeing dramatic improvements in their process, especially in the areas of traceability, impact analysis, and test management.

As soon as they began importing their data into Jama Connect, Össur’s engineers saw they had traceability gaps. “Catching these gaps would probably have taken hours or days in our old system,” says Langlois. “With Jama, it became obvious in a matter of minutes.”

With Jama Connect’s impact analysis, teams can quickly gain an accurate understanding of the implications of a proposed change. So, in turn, they can make better informed business decisions. “That brings a lot of value when you’re trying to run a review, and you want to know whether you have gaps in your test coverage,” says Langlois. “With Jama, it’s a five-minute question instead of one that takes hours.”

In addition, Össur feels Jama Connect’s test coverage and built-in metrics are making its testing process far more predictable and efficient. “One thing that’s very powerful about Jama Connect is that, after a few test runs, you can actually quantify pretty accurately what sort of effort is required,” Langlois says. “Jama provides all these metrics that allow you to identify where your bottlenecks are, giving you a better understanding of where the time is going and where you’re losing money.”

Leveraging Jama Connect’s Flexibility for a Faster, More Flexible Future

As Össur branches Jama out into other areas of its organization, it plans to allow individual teams to configure Jama Connect in a way that best suits how they work. And Össur is already thinking about ways to integrate with some of the other solutions it’s currently using.

“As a software developer, I think Jama Connect’s integration with Jira is going to be very useful for me,” says Matthías Kristjánsson, Product Lead Designer at Össur. “Today, we actually make duplicates of our requirements into the Jira system. Being able to connect them straight to Jama and remove that step — so they’re directly connected to a requirement or specification — will be valuable.”

Read the full case study to learn more about how Össur is using Jama Connect to grow more agile and efficient and assure compliance with relevant regulatory standards.

Traceability is the tracking of requirements across the product development cycle. It documents the status of everything being worked on and shows the history of development along with the impacts of specific changes. Its benefits include easier regulatory compliance, more in-sync teams, and higher-quality releases.

A dedicated software traceability solution may be relied upon to systematically track and trace a requirement’s life. Compared to using discrete documents (e.g., spreadsheets) for the same purpose, this type of centralized platform lets teams make easier, more accurate assessments that support more informed decisions about products. It can dependably identify who made each change, what the change entailed, and why it was made – all in one system of record.

Accordingly, such a platform enables superior software requirements testing and management, in industries as varied as medical device manufacturing and automotive production. Let’s look at five tips for how to improve requirements traceability, along with how traceability software helps with each one.

1. Use Real-Time Communications To Empower Teams

Many requirements traceability processes are highly manual and disconnected:

  • For example, Team Member A creates a traceability matrix in Microsoft Excel. This matrix is a table containing artifacts like requirements, test cases, test runs, and identified issues. Its purpose is to show that compliance requirements for a project are being met.
  • However, the artifacts in it get frequently updated during the course of development and testing. So Team Member A goes back in periodically to update the traceability matrix and make sure it is fully up-to-date. This is time-consuming and error-prone work.
  • Team Member B then has to dig through this matrix to see if the changes are relevant to them. It’s possible that what they see at any given point isn’t accurate, though. Keeping up with changes is its own job, with many back-and-forth email barrages to navigate.

Real-time communications within a traceability solution alleviate these issues. Instead of hopping between static documents scattered across emails, team members can collaborate in one virtual space, in which they can share feedback, participate in livestream discussions, see connections between items and their authors or editors, and expedite reviews and approvals. They also have access to all comments, test cases, and activity streams from the same interface.

Such features ensure that changes are communicated directly to the relevant parties and that software traceability stays on track. Team members do not have to waste time poring over a document that might not be 100% accurate or even applicable to their particular responsibilities. Basically, real-time communications remove the traditional bottlenecks of hunting for the latest updates and wondering about their relevance.

2. Chart the Impact of a Change Before it Happens

As noted above, requirements change all the time during software development. It is essential not only to keep team members in sync about these changes, but also to scope out their full impact across the product development lifecycle.

Altering one requirement will directly affect any related system requirements, along with downstream requirements and numerous verification tests. Teams need insight into what these changes will entail, so that they can see if related items are still correct, make any necessary updates, and ultimately trace the right requirements for quality and compliance purposes.

Live traceability in Jama Connect allows for better impact analysis and more streamlined navigation of upstream and downstream relationships:

  • For instance, links downstream from modified items are automatically flagged as “suspect” to alert team members to the need for possible action.
  • Relevant contributors can also be notified right away, and critical decisions prioritized; meanwhile, everyone else can save time by not being pulled into something irrelevant.
  • System users can see if a requirement has test cases downstream and what percentage of them have passed.
  • With all risks and requirements being updated in real time, teams can reliably trace them and conduct informed evaluations and analyses.

Through these capabilities, a traceability solution helps everyone be more confident that they are working with the right requirements, while avoiding getting bogged down in rework or in costly late-stage changes caused by not having an accurate picture of what is being worked on at every stage. In other words: Live traceability means that traceability is no longer an afterthought.

3. Create a Detailed Audit Trail With Well-Documented Changes

One of the main reasons for implementing traceability software is to simplify regulatory compliance. Let’s say that a hypothetical medical device manufacturer is planning to bring a new connected device to the U.S. market.

The Food and Drug Administration requires compliance with regulations such as FDA 21 CFR Part 11, regarding electronic records and e-signatures. Creating a detailed audit trail to comply with these rules is more straightforward if a unified system of record with full version histories – i.e., a software traceability solution – is in place. Jama Connect Review Center is compliant with FDA 21 CFR Part 11.

Modern traceability software maps out the relationships and interdependencies in product development, allowing for assiduous tracking of risks and requirements in their full historical context. Real-time collaboration also enables even geographically distributed teams to stay on the same page in tracking and tracing work items. This level of traceability, with visibility into who made each change and for what reasons, has become especially important as medical devices become more complex and software-driven.

In Jama Connect, risk analyses and other data such as product-specific views can also be easily exported to the correct formats to prove compliance. Industry-standard templates are available as well to minimize the setup time for creating a plan that aligns with standards such as ISO 14971:2019, ISO 13485, and FDA 21 CFR 820.30.

4. Connect Everyone and Everything with Trace Relationships

Traceability is about relationships. Because each product in development has its own particular set of customers, stakeholders, and internal team members associated with it, traceability is only possible if these individuals can be accurately connected to the items for which they are responsible.

That principle sounds simple enough on paper, but putting it into practice can be more complicated. Consider the question of who responds when a series of changes occurs and checks to see if everything is still right. With complex products, multiple team members will likely have to weigh in on and then sign off on these changes, a process that presents some big challenges:

  • Decision-makers might not have clear visibility into the impact of changes to requirements, like their ripple effects on downstream or upstream items.
  • High-quality data on requirements-related changes and why they were done might not be readily available and shareable, either.
  • Coordinating the decision-making process itself can be cumbersome, with everyone exchanging documents via email and struggling to get in sync.

 

Fortunately, these obstacles can be overcome with traceability software. By implementing a shared system of record with real-time communications capabilities, organizations can adeptly manage their trace relationships and relieve the various forms of decision pressure outlined above.

5. Make Traceability More Proactive To Ensure Test Coverage

 

Traceability should not be pursued after the fact. Connecting requirements and other items at a relatively late stage is a recipe for trouble, as it can become difficult to gather all the necessary information and put into proper context. Extensive manual work, and the risks that come with it, are also likely to be required in such a reactive workflow.

 

In contrast, proactive traceability done throughout the product development lifecycle helps reduce risk and pave the way for higher-quality products that align with all of their requirements. Automation is key to this proactivity. Traceability software like Jama Connect automatically saves user inputs, can apply risk level updates in real time in accordance with a user-defined risk matrix, and ensures a standardized approach to risk evaluation across the organization – eliminating silos and disjointed processes.

A traceability solution also provides clear visual representations of the status of requirements, test cases, and test runs along the way. These data-rich views enable better decision-making, since team members are working with live, easy-to-understand information and can communicate with each other through the same platform. For example, users can easily see test coverage levels and where gaps exist.

Take the Next Steps With Traceability Software

The right traceability software lets organizations efficiently manage all of your requirements in one place and streamline the development process of even the most complex products. It saves the entire team time and money, accelerates development lifecycles, reduces the risk of error, and results in improved product quality and regulatory compliance.

In short, traceability provides essential context and clarity. Look for a modern traceability solution that will keep projects on schedule, on budget, and within scope, thanks to better collaboration and requirements management.

As medical device developers compete to push the boundaries on designing and building innovative, connected medical devices, the market continues to boom. It doesn’t look to be slowing down anytime soon, either. KPMG estimates that global annual sales of medical devices will rise by over 5 percent a year to reach nearly $800 billion by 2030.

Modern medical device makers are hyper focused on building innovative, connected solutions for the next generation of care. That continued innovation opens the door for new, lower cost technologies for early intervention and at-home care. But it also opens the door for more risk.

In the past, medical device software was generally used to control programs to simply switch the equipment on and off and display readings. Today, software and its functions dominate much of the features, making devices far more integrated, complex, and connected-and growing more so every year.

Growing Concern for the Security of Connected Medical Devices

While smart devices provide opportunities for instantaneous results and early medical intervention, connected medical devices are also more vulnerable to both deliberate attacks and undirected malware.

A survey released in October 2018 of 148 healthcare IT and security executives, conducted by Klas Research and the College of Healthcare Information Management Executives (CHIME), showed that an astonishing 18 percent of provider organizations had connected medical devices impacted by malware or ransomware in the last 18 months.

The threats against medical devices have become such a concern that two U.S. federal agencies recently announced a new initiative to address vulnerabilities. In October 2018, the U.S. Food and Drug Administration and the U.S. Department of Homeland Security (DHS) announced a memorandum of agreement to implement a new framework for greater coordination and cooperation between the two agencies for addressing cybersecurity in medical devices.

Read this case study to see how RBC Medical Innovations leveraged Jama Connect to unify processes and enhance traceability.

Modernizing Requirements Management to Reduce Risk

The reliance on connected medical devices isn’t going to ebb, and the increased complexity will only make the management and reporting of interconnected information across product definition and verification more difficult and inefficient. This inefficiency is only exacerbated by the use of document-based requirements management, which introduces more risk into the process.

To achieve better results with projects of mounting complexity, teams must get a stronger handle on their process and avoid gaps in development. A better solution for requirements traceability can do just that.

Traceability, normally a sub-discipline of requirements management, ensures that engineering design aligns with the identified needs of users and patients; manages scope by ensuring alignment between engineering work and actual user needs; confirms that device needs are addressed at all levels through gap analysis; and connects the design of the device directly to the verification.

Requirements Traceability is No Longer Optional

Small teams building simple products may be able to get by initially with spreadsheets, documents, and emails, but with the rise of software-driven, connected medical devices and increasing system complexity, requirements traceability quickly becomes too convoluted to be handled manually.

The reality is that the more complicated or distributed the product development process becomes, the more opportunities for error are introduced. Excel just can’t account for the wide array of risks and requirements involved in medical device development.

In fact, according to Stericycle’s Recall Index, software issues were consistently one of the top causes of medical device recalls through 2017 and 2018.

Learn how Jama can help you better manage risk with ISO 14971 by downloading our white paper.

Today’s medical devices are so much more than metal and plastic – they’re incredibly complex, connected devices that require complete hardware and software traceability.

Medical device development contains too many scope changes, remote team members and reviewers, and requirements to be easily managed in documents and emails. Using Excel or an internally developed requirements management solution or system diverts scarce resources and availability away from the important tasks of product development. Instead, team members have to focus on attempting to assemble and maintain traceability, usually resulting in the trace being hastily thrown together in the end for the design history file (DHF).

Traceability increases efficiency, drives alignment, and mitigates organizational risk. And with Jama Connect, teams can link and decompose high-level requirements to more detailed system and sub-system requirements, including associated risks and hazards, to ensure proper verification and validation before release.

Download our eBook, Conquering Connectivity, Competition and Compliance, to learn about the top three challenges that modern medical device makers face and how to overcome them.