In Part II of our six-part automotive series, our experts discuss how to ensure functional safety compliance using Jama Connect for Automotive. If you’re new to our Automotive Development blog series, you may want to go back and read Part I and the Series Intro.
While safety has long been an important aspect of developing automotive systems, traditional safety considerations have largely involved mechanical systems. The modern automobiles, however, are increasingly relying on electronic systems and significant amounts of software. This increase in electronics in vehicles brings in new considerations when it comes to functional safety compliance.
Note: Now that our automotive development blog series has concluded, you can go back and read series intro and Part I.
Functional Safety Compliance: ISO 26262
The standard that is concerned with the functional safety of electronic systems is ISO 26262. ISO 26262 is actually a series of standards that provides a framework for developing both electronic hardware and software systems where functional safety must be achieved. The standard describes a process for identifying risks in a system and provides guidance for mitigating those risk. The guidance is provided in the form of requirements and processes that are understood by the industry as the current state of the art for achieving functional safety.
A major component of ISO 26262 is a robust series of processes for requirements management and traceability. The processes require that organizations develop safety goals, translate those into functional requirements, technical requirements, and eventually both hardware and software requirements as appropriate for the system. The system must then be fully verified against all requirements and specifications. Critically, the processes require that traceability between the requirements, specifications, and verification activities be maintained and all documentation carefully reviewed.
Jama Connect for Automotive
A requirements management tool like Jama Connect for Automotive reduces the manual effort required in adhering to ISO 26262. Jama Connect for Automotive’s traceability features are ideally suited to maintaining and analyzing the required traceability. The review features are the ideal way to ensure documentation is fully reviewed and approved by a cross-functional team. The export features generate well-formatted documents for many of the work products required by ISO 26262.
The flow diagram below summarizes the ISO 26262 processes that can be managed in Jama Connect for Automotive. The boxes with an orange border represent the recommended work products to be captured in Jama Connect for Automotive. The boxes with a gray border represent the work products that benefit from being captured in Jama Connect for Automotive, but some organizations might choose to capture elsewhere.
High-Level ISO 26262 Process in Jama Connect for Automotive
Jama Connect for Automotive includes a fully functional framework that software teams can use to start getting value immediately. This includes complete documentation for how to complete each process most efficiently in Jama Connect for Automotive. Industry-specific Professional Services are also included to guide customers through the inevitable customizations needed by each organization. A complete list of the processes for working in Jama Connect for Automotive that align with ISO 26262 are listed in the table below.
ISO 26262 Alignment to Jama Connect Processes
To learn more about how Jama Connect for Automotive can help your team simplify compliance, streamline development, and speed time to market, download our solution overview.
Do you know the most common product development challenges engineers face? In this post, we have identified them and provided solutions that enable a more modern and efficient product development process.
An ideal product development process requires close collaboration between teams, up-to-date knowledge of applicable regulations, and efficient requirements management platforms for defining, verifying, and validating requirements. However, not every manager is convinced that his or her team needs to do a better job on requirements development and management, or that such an investment will pay off—despite numerous industry studies which indicate that requirements issues are a pervasive cause of project distress.
With the growing complexity of products and software, the more complicated the process required to build it becomes—and the accompanying increased risk of flaws which can lead to expensive, and potentially reputation-harming recalls.
These new complexities have raised the stakes—and made the case—for the need to optimize the product development process from end to end. Engineering and design teams need solutions to the most common product development challenges that provide purposeful, structured collaboration; connect globally distributed team members; and accurately capture and facilitate feedback, decision making, and context for requirements under review.
Doing so requires first overcoming some significant obstacles. To help navigate the journey toward better product development, let’s examine ten of the most prominent product development challenges engineers face and their corresponding solutions.
1. Move on from outdated legacy or document-based solutions
The Product Development Challenge: The traditional approach to managing risks and requirements is highly manual. Teams that operate with a documents-based approach, exchange numerous spreadsheets, and versioned documents via email. This method has real drawbacks:
No single source of truth: A spreadsheet with a project’s traceability matrices could have many cells, but no guarantee its data was authoritative or even up to date. Different versions might be floating around, requiring any changes to be painstakingly manually coordinated to achieve team-wide alignment.
Limited collaboration: Sending complex requirements documents over email leads to important updates getting lost in people’s inboxes and projects being delayed. As remote teams become more common, such issues are even trickier to manage.
Excessive rework: Without effective change management—which is very hard for teams who rely on static, emailed requirements documents—teams often end up developing (or testing) off of older versions of requirements which inevitably leads to misalignment and costly rework.
The Solution: Jama Connect™ provides the single source of truth absent from document-based solutions. Teams from anywhere can collaborate in real-time on a unified platform and capture accurate feedback, review progress, and conduct approvals. That leads to earlier identification and control of risks, which helps reduce rework and keep projects on schedule and under budget.
2. Simplify compliance and meet regulations or standards
The Product Development Challenge: Product development has become much more complicated over time. As a result, so has product risk—and the accompanying regulatory compliance required.
A Jama Software-sponsored survey on Engineering.com found that 62% of respondents reported being reprimanded by regulatory agencies for product development issues. More broadly, recalls have been increasing in certain industries, with medical device recalls more than doubling year-over-year in Q1 2018, due primarily to software-related defects.
The Solution: To address these product development challenges, Jama Connect is engineered to ensure quality with frameworks aligned to key industry standards that streamline design, development, and risk management while maintaining compliance.
Jama Connect helps customers in industries like medical device, aerospace, and automotive solve this product development challenge by streamlining their quality and risk management processes with defined processes for development and production and detailed traceability—from the high-level user needs and systems requirements through to validation and verification. Teams can streamline their product development with templates aligned with industry standards, compliant reviews and approvals, and end-to-end traceability making audit preparation and record-keeping a straightforward process.
3. Establish and implement effective review cycles
The Product Development Challenge: Without the right platform and processes in place, review cycles can be time-consuming and fragmented. For example, under the manual approach to requirements management described earlier, a review cycle can be repeatedly delayed due to versioning issues with documents and lack of visibility throughout the review process. Teams can also spend hours per week in review meetings, just to ensure everyone is on the same page.
Streamlined review cycles require:
One source of truth for requirements and tests
A straightforward way to send items like requirements, user stories, or test cases for review
Best practices for each of the major roles involved (i.e., reviewer, approver, moderator)
Real-time collaboration within a shared, dynamic requirements management platform
A formal approval process to capture and record sign-off
The Solution: Jama Connect Review Center can solve this product development challenge by serving as the single place for reviewers, approvers, and moderators to collect and manage all requirements and feedback for a project in real-time.
Inviting internal and external collaborators into a review cycle is easy, plus roles can be assigned and all agreed-upon requirements approved much more quickly than with manual processes. Pharmaceutical manufacturer Grifols reduced its planning time by 80% by using Jama Connect to accelerate review cycles.
4. Enable secure, cross-functional collaboration across teams, customers, and complex supply chains
The Product Development Challenge: People working together is at the very core of all product development work. The ability to effectively collaborate is critical for innovation. In this era of rapidly accelerating change, structured and strategic team collaboration is the key to improving the product development process for all team members. And in this era, the “team” includes everyone across the supply chain.
Today’s market demands require companies to build partnerships and seek solutions with more specialized materials. These partnerships mean greater sharing of data across distributed teams, partner organizations, and business units, sending a ripple effect through the supply chain as subsystem suppliers must anticipate features on the finished products and get ahead of release schedules and component costs.
But for engineers who are used to working on internal, siloed teams, these new partnerships present previously unforeseen challenges. What worked before doesn’t work today.
Aligned requirements management is necessary for developing products that meet all customer and market requirements while adhering to industry regulations and standards. More specifically, optimized gathering and authoring of requirements are needed to ensure product quality and meet specific requirements, minimize risks, accurately scope projects, enable collaboration, and align teams.
The Solution: Requirements gathering should follow a systematic process, focused on what eventual end users will do and the requirements that must be met to support those behaviors. This approach ensures that both high- and low-level requirements and their dependencies are covered and that corresponding tests can be set up and run.
As teams seek input and feedback on product and systems requirements, tools like Jama Connect are critical in capturing these insights in real-time. With everyone having access to the most up-to-date information, stakeholders can stay informed and aligned, reviews can be streamlined, and teams have better visibility into the progress of their work. This helps reduce the complexities of communication and saves time by having a single source of information regardless of geographic or institutional location, which enables collaboration across a variety of relationships. Having a single platform where these teams can come together to review and connect will keep programs on track, keep teams collaborating, not let insights slip through cracks, and allow for innovation.
Engineers typically collaborate with outside companies by exchanging requirements. Data Exchange for Jama Connect enables the transfer of requirements and associated metadata between customers and suppliers. The solution allows for the import, export, and update of requirements data to create an ongoing exchange throughout the product development lifecycle, allowing for collaboration to extend to remote engineering teams and companies.
RBC Medical (now known as Vantage Medtech)saved an average of $150,000 per project by upgrading to Jama Connect eliminating the back-and-forth email tag that characterized its previously manual processes.
5. Ensure product quality and improve change management with complete traceability
The Product Development Challenge: Maintaining cross-team visibility and staying on top of disparate documentation and processes along the way is a central challenge of working with manual, document-based workflows. It becomes difficult to accurately assess the impact of a proposed change (i.e., perform impact analysis) and to ultimately ensure requirements are properly tracked across the entire product development lifecycle.
The Solution: To make impact analysis more scalable, teams need end-to-end traceability. In Jama Connect, links that are downstream from modified items get automatically flagged as “suspect,” and relevant contributors can be notified right away to take corrective action. 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.
Important data, such as the percent of downstream test cases that have passed and where coverage may be missing, is also easy to view, while the system’s requirements can be updated in a centralized place as the project progresses.
The right requirements management technology can provide clear traceability that allows teams to maintain a rigorous formal change management process; reveals interdependencies with the process; and enables alignment, making it easier to bring in the right decision-makers at the right time. This level of traceability, with visibility into who made each change and for what reasons, has become especially important as products and systems become more complex and software-driven.
The result is improved confidence that teams are working with the right requirements, have the information they need to conduct useful impact analysis and are generally able to trace forward from, and back to, requirements as needed.
6. Manage development complexities across hardware and software teams
The Product Development Challenge: Software is an ingrained part of modern product development and one that can greatly increase risk if not properly managed. Moreover, complex software requirements have to be managed in tandem with those for hardware. The growing connectivity embedded into today’s ever more complex and often safety-critical products, puts pressure on both software and hardware teams to manage their development processes with more efficiency and effectivity. In fact, in a recent study from Engineering.com, over the last five years, 76% of respondents reported dealing with three or more increased measures of complexity and 25% saw their products become more complex in five or more ways.
The Solution: In a platform like Jama Connect, risks and requirements related to software and hardware can be managed proactively, not reactively. Teams can quickly see the full historical context around a requirement when they receive invitations to contribute to a project. Out-of-the-box frameworks that include industry-specific, software development methodology and risk management also minimize setup time, so that important risks in software and hardware can be identified, assessed, and acted upon as early as possible.
Configurable workflows accommodate various process styles, development methods, and tools to ensure adoption, with flexibility to support your Agile, Scaled Agile or Hybrid development process. Requirements data can be integrated with other tools across the development process to ensure everyone stays aligned.
One of the most common scenarios is integration of requirements to Atlassian Jira. With the Jama Connect for Jira integration, product teams can maintain critical information about their product requirements and test cases and directly connect them to development activities in Atlassian Jira, including sprint planning, task management, estimations, and defect and issue tracking.
7. Increase quality and efficiency by testing earlier in the lifecycle
The Product Development Challenge: It’s well understood that identifying potential defects earlier in the lifecycle prevents costly rework. But how can organizations proactively involve QA at the front end of the process?
The Solution: Early testing prevents defects from surviving until the late stages of the lifecycle, when they become especially costly to fix. In addition, early and frequent testing allows for innovation.
The National Institute of Standards and Technology has estimated that the relative cost of fixing a software bug is 30 times higher in production than in the requirements and architecture stage of development.
Conducting some form of testing, at every stage of the product development lifecycle, is highly recommended. Getting the right feedback at the right time ensures that you can deliver a high-quality product on time.
In the early stages of development, performing customer exploratory testing is the most cost-effective way to make sure your product strategy is on the mark. And, at the end of the development lifecycle, conduct system integration tests to ensure components are working harmoniously.
Jama Connects helps engineering and quality assurance teams define, organize, and execute requirements-based test plans and test cases to ensure quality and compliance. Teams can streamline reviews and approvals, perform manual testing, and integrate with trusted test execution and automation solutions.
8. Implement effective requirements versioning, baselining, and change management
The Product Development Challenge: Legacy requirements management systems frequently complicate version control, due to the prevalence of conflicting requirements documents that are manually managed, often owned by varied teams and then distributed cross-functionally. Likewise, they don’t provide the right infrastructure for effective change management, because of the difficulty involved in identifying the latest versions and applying any needed changes amid all of the different documentation in question. Changes might ultimately be made only at a late stage, and at great cost.
The Solution: A requirements management platform like Jama Connect can solve this product development challenge by allowing teams to align their releases to ensure they deliver a cohesive solution/product to their customers. With versioning, baselining, and change management of the requirements in place, teams are able to manage and reuse requirements throughout the development lifecycle. This allows development teams to improve reuse, reduce design inconsistencies, and reduce the discrepancies found during testing, verification, and validation.
Jama Connect offers full control over the requirements you are choosing to reuse. You can not only choose the set of requirements you want to reuse but also the version of those requirements as well. This allows you to take the best and most applicable version of your requirements forward to your next project.
Studies reveal that 60 to 80 percent of requirements, code, and tests are shared between projects. With Jama Connect, you can reuse your data for effective sequential or parallel product development which saves your development teams time and improves time-to-market.
9. Make it easier to coordinate remote engineering teams
The Product Development Challenge: Remote work is on the rise. Although it has many benefits in team flexibility and cost savings for the organization as a whole, it can complicate collaboration and result in additional operational silos as each remote engineer settles into their own workflow and preferred set of tools.
The Solution: Modern platforms that enable real-time, structured collaboration simulate the efficiency of engineering teams working together in a shared physical workspace. For example, engineers can be easily invited into Jama Connect conversations and reviews, notify each other with custom messages and supporting context, and be assured that they’re always working with the latest information.
Such a setup solves this product development challenge by reducing silos and keeping everyone aligned. Buffer’s State of Remote Work survey for 2020 found that communication and collaboration were among the most cited challenges with telecommuting. Teams that still operate in silos with legacy systems will not be equipped to meet the demands of the market going forward. In this era of rapidly accelerating change, structured and strategic team collaboration is one of the best ways to address the product development challenges and obstacles of the modern product development landscape.
10. Build a more effective and efficient product development process
The Product Development Challenge: Product development is complex and, in most cases, will span multiple teams, solutions, and methodologies. Outdated legacy tools and a documents-based approach aren’t enough for this reality, as they aren’t purpose-built for complicated requirements management.
The often-quoted CHAOS Reports from The Standish Group indicate that three of the biggest contributors to projects that fail or are “challenged” are:
Lack of user input
Incomplete requirements and specifications
Changing requirements and specifications
The Solution: An evolutionary leap forward comes from modernizing requirements definitions as well as engineering and management processes—including minimizing the time your team members spend eliciting, analyzing, documenting, validating, and managing the requirements for their products.
Do you have product development challenges you need to solve?
Jama Connect is a solution for managing complex product requirements from idea through development, launch, and iteration. It brings people and data together in one place, providing visibility and actionable insights into the product development lifecycle. Our platform equips teams to track decisions and ensure the quality of the product they set out to build.
We’d love to speak with you and share how Jama Connect can help your teams find solutions to your unique product development challenges and overcome these 10 common ones. Connect with us today and get started with a better approach to managing requirements in product development.
To learn more about optimizing engineer team collaboration to streamline product development, download our eBook now!
Infographic: Jama Connect™ for Medical Device Development
We’re excited to share our latest infographic for the Jama Connect for Medical Device Development solution which explains how Jama Connect can help accelerate innovation, maintain product quality, and manage the ever-changing complex regulations in medical device development. This is a single powerful platform for medical device teams to manage design controls for device requirements and related risks, simplifying regulatory submissions, and audit preparations while accelerating time to market.
Bringing a medical device to market requires navigating a sea of complex and ever-changing regulations, not to mention bearing significant costs along the way. A device recall can cost $600 million, while the indirect costs of lost revenue and diminished market cap are even higher at $1-3 billion per company. Those costs are especially significant considering the price tag of product development—$75 million in FDA compliance alone, and an average timeline of three to seven years.
→Jama Connect customers have been able to reduce planning time as much as 80%, thanks to consolidated feedback replacing emails and a document-based approach to project management.
→Better quality products get out the door faster. By understanding the impact of change, capturing decisions and feedback in real-time and reusing existing IP, Jama Connect reduces medical device development time by an average of 130 days per project.
→Jama Software reduces rework, which accounts for approximately 30-50% of a given project and arises from issues such as requirements errors. Improving the ability to track requirements from design through verification and validation ensures teams build the right medical devices with the lowest possible lifecycle costs.
In this infographic,we share how, with the right requirements management solution, you can accelerate the development of cost-effective products that also comply with both safety and quality standards.
You’ll learn:
How to overcome the biggest challenges in medical device development
The ways Jama Connect for Medical Device Development can help
Keys to unlocking a better customer experience
WEBINAR: TIR45 | An AGILE Approach to Software Regulatory Compliance
Are you ready to seamlessly move from CLIA, Research Use Only (RUO) or Emergency Use Authorization (EUA) to a clinical software product?
Join us as we discuss an AGILE approach to software regulatory compliance. We’ll be hosting this informative panel discussion with the owner of Agile Quality Systems and principal author of AAMI TIR45, Kelly Weyrauch, and our partner (and panel host) Beanstock Ventures as we to discuss bridging the gaps between modern software development and regulatory requirements.
This panel de-mystifies the belief that Agile development lacks the proper controls for producing safe and effective software and that the regulation is burdensome. We will share experiences, ideas, and tools you can use for your software regulatory compliance while still staying adaptive and effective.
Date: Thursday, May 20th, 2020 Time: 10:00 – 11:00am PST
Our panelists include:
Adam Darmstadt–VP of Product Development, BeanStock Ventures Adam is a software engineer with over 19 years of medical device and life science industry experience. Adam and his team are passionate about using lean and AGILE methodologies to speed up reaching the end goal without compromising quality.
Clay Moore –VP of Customer Success, Jama Software
With over 20 years of experience architecting and delivering SaaS-based enterprise solutions, Clay and his team help medical device development teams modernize their approach to requirements, risk, and test management to improvequality and delivery.
Kelly Weyrauch–Owner, Agile Quality Systems& a Principal Author of AAMI TIR45
As one of the principal authors of AAMI TIR45 “Guidance on the use of AGILE practices in the development of medical devices software”, Kelly has worked with the FDA and industry leaders on the application of AGILE practices to the medical device world.
