Supply chain collaboration: Interactive or ReqIF. Which is right for you?
There are two main types of requirement collaboration in the supply chain: Interactive and ReqIF. While interactive collaboration is on the rise and offers the most benefits, there are cases where it is not feasible. Jama Software supports both methods and, in this post, we will discuss each method’s use-case and pros/cons.
Interactive Collaboration: The High-fidelity Option
We all know that collaboration in product development helps improve quality, reduces risk and speeds up development. For this reason, Jama Connect® has context-based, interactive collaboration built into the platform. Reviews are a formal, effective collaboration method that guides teams in fulfilling regulatory requirements.
In addition to using these industry leading capabilities in-house, our customers frequently use these capabilities to collaborate with external stakeholders. For instance, Jama Connect allows you to invite reviewers simply by email (Jama Connect licenses include more than enough reviewer licenses for this purpose). This works extremely well in practice. In fact, one medical device developer, RBC Medical Innovations(now known as Vantage Medtech), was able to shed hundreds of team-member days during development to save $150,000 in cost savings per project.
As a fully web-based software as a service (SaaS) product, Jama Connect offers customers a standard and secure web interface for cross-department or cross-company collaboration. Inviting customers or suppliers into your Jama Connect system is as easy as sending an email. User security can limit what is seen and allows for granular control of permissions. Our full version tracking enables everyone to see what has changed, who changed it and all impacts on upstream/downstream traceability.
The Alternative: Controlled Data Exchange via ReqIF
Data exchange between organizations is nothing new, and many organizations have collaborated for decades, typically by exchanging documents. While this approach technically works, it results in unstructured data that provides no traceability, no understanding of changes between versions and no easy way to provide structured feedback.
The automotive industry is a great example of complexity across the supply chain with OEM’s traditionally working with hundreds of suppliers. It’s not unusual to find tens of thousands of requirements in an automotive specification, so managing these requirements is a challenge. In response, the industry developed an international standard for the lossless exchange of requirements called Requirements Interchange Format (ReqIF) and the standard was finalized in 2011.
A requirements exchange with ReqIF has some similarities to the old (and dreaded) document exchange process: One party exports a ReqIF file and hands it to the other party. The transfer can happen via a portal upload, automated exchange or even as an email attachment.
But here’s where the similarities end: A ReqIF file contains structured requirements data consisting of individual requirements with visibility into structure, attributes, related elements, and traces. ReqIF also supports incremental updates. If one party creates another version and exports a month later, you could import that version into your environment and the tool would show you clearly which elements, attributes, and traces have changed. For instance, you could use suspect links to re-validate only those items that have changed. Compared to trading .pdf files, which yes believe it or not many organizations still do, this is an extremely significant time saver and error avoiding capability.
While the standard is certainly more advanced than simple document sharing, it does have drawbacks. Not every tool adheres to the standards in the correct way. Data exported can be missing embedded images, required fields in one system are not required in another and user information (meta-data) is not universally available.
ReqIF is commonly used to solicit feedback from a supplier. A producer could export the requirements for a supplier, including attributes for providing status feedback and comments. The supplier would then import the ReqIF file into the tool of their choice, where they could fill out the supplier attributes and send the resulting export back.
In addition, they could start integrating the imported requirements into their own development system. For example, they could establish traceability from the customer requirements through to design while keeping the process invisible to their customer.
There are other use cases that ReqIF supports as well, but for all of them, the foundation is a controlled asynchronous exchange of structured requirements that keeps individual items, attributes and traces intact. Jama Connect supports this workflow and we have many customers that are using it today.
Bottom Line: How to Collaborate?
If you are using Jama Connect, the built-in collaboration capabilities are the most effective way to work together. Having 100% Live Traceability™ has been proven to increase product quality while reducing time to market.
However, if you are working with people outside your organization, that may not be able to collaborate using your Jama Connect instance a ReqIF-based collaboration could be an acceptable alternative.
https://www.jamasoftware.com/media/2022/08/2022-08-10-supply-chain-reqif-1.jpg5121024Josh Turpen/media/jama-logo-primary.svgJosh Turpen2022-08-09 03:00:052024-06-21 13:09:42Supply chain collaboration: Interactive or ReqIF. Which is right for you?
Eight Ways Requirements Management Software Will Save You Significant Money
Requirements management software helps development teams eliminate manual compliance efforts and significantly reduce product delays, rework, and cost overruns. Some platforms, like Jama Connect®, also include frameworks and templates aligned to industry standards — and enable live requirements traceability through siloed development, test, and risk activities, providing end-to-end compliance, risk mitigation, and process improvement.
In this post, we’ll share the eight ways that a requirements management platform can save your company significant money, making it a wise investment at any time — especially during challenging economic times.
Requirements Management Software can help your organization save money by:
1. Reclaiming Productive Work Time
A modern requirements management solution (like Jama Connect®) can help your teams reclaim hours of unproductive work time, resulting in money saved across the organization. Without a modern requirements management solution, highly skilled – and often highly paid – employees can waste up to 40% of their time on tedious, unproductive activities such as:
Searching for siloed information in static documents and/or disconnected tools
Manual/or duplicative data entry to update status in multiple systems
Working off old data and outdated versions of documents
Reformatting and migrating data back and forth between tools
Reconciling differences between data sources
Trying to understand ‘what changed?’ and assess the impact
After implementing Jama Connect, our customers on average, quantify that they are reclaiming one to two hours of productive work time per day, some even more. The engineers at Monolithic Power Systems can now quickly and easily produce required documentation and no longer need to spend time in multiple time-consuming meetings and scrums to get a clear picture of what’s happening with their products. And with Jama Connect, they can automatically generate — at times — 70-80 pages of documentation (entered correctly one time, in one place) and efficiently generate any additional documentation they need, saving their engineers countless hours of documentation time.
Another customer, RBC Medical Innovations(now known as Vantage Medtech) shared that on one of their state-of-the-art capital equipment development projects, Jama Connect saved them 123 team-member days with an average cost savings per project of $150,000. And medical industry innovators and pioneers in the field of plasma science, Grifols, reports saving 80 hours or more per project after implementing Jama Connect.
Interested in the numbers?
Let’s take, for example, this simple calculation.
If you have 10 team members engaged in core requirements management activities, and each spends roughly four hours on the above-listed unproductive tasks per weeks, the annual budget reclaimed with Jama Connect would be $94,118.
Note: The calculation assumes 237 actual working days per year (at an average salary of $100K) with each author in Jama Connect reclaiming a conservative one hour per day.
Test this out with your own numbers using the interactive calculator below!
2. Reducing Rework
How much money are you leaving on the table due to rework? See how much you can save by decreasing discovered and unplanned work due to:
Improperly defined requirements
Incomplete decomposition and missing coverage
Insufficient review and stakeholder alignment
Lack of rigor and impact analysis when managing change
Late-stage requirements churn
Again, let’s assume an organization has an average product development investment cost of $10,000,000. (Typical rework costs average about 30% of development costs, so in this case, it would be $3,000,000. And rework costs due to poor requirements management averages about 60% of rework costs, which, in this case, would be $1,800,000).
Our customer data shows that Jama Connect typically reduces requirements management rework by 40-60%. So, with these calculations, the organization can expect to reclaim, a not insignificant, $900,000 of annual budget with Jama Connect.
In one example, our customer, Arteris IP has seen not only seen reuse go up by 100%, and review times down by 30%, but also a significant 50% reduction in rework since using Jama Connect.
Test this out with your own numbers using the interactive calculator below!
3. Streamlining the Review Process
For product developers and engineers, reviews are a cornerstone of the development process. How much are inefficient requirement review meetings costing your organization? Is your review process cumbersome, manual, in disparate documents, and challenging for distributed stakeholders to collaborate? If so, it might be time to (forgive the redundancy) review your review process. Healthcare leader, Grifols shared that with Jama Connect, they have reduced their review cycles from three months to fewer than 30 days.
Legacy solutions that are difficult to use can make the review process incredibly cumbersome, diverting frustrated team members out of the tool and onto ineffective (often quickly outdated) versions of disparate documents. This is a story we’ve heard repetitively from customers who’ve moved away from legacy tools and processes.
If that’s one of your frustrations as well, it might be time to see how much budget you can reclaim through review optimization, including:
Virtualizing reviews for asynchronous collaboration
Focusing key stakeholders on the most relevant information
Adopting a more iterative approach
Increasing upfront rigor and version control
Tracking participation and progress
For this calculation, we’ll assume three variables:
Total number of requirements review meetings per month
Approximate duration of each review meeting
Average participants in each meeting
Let’s assume six review meetings per month, each meeting lasting three hours, and an average of 10 people involved in each review meeting. Calculating with an average salary of $150K/per attendee, and with the above-defined variables, the annual cost of review meetings would be $162,000. The total number of people hours in review meetings would be 180 hours.
The calculated savings alone, by just reducing the time spent in meetings, would be $81,000.
Jama Connect typically reduces time spent in meetings by 40-60%. Notably, the Finnish Red Cross estimates that implementing Jama Connect has shortened their review cycles by an impressive 80%. What could you get done with all that time back?
With Jama Connect, you can simplify the review and approval process by capturing collaborative feedback from stakeholders, including voting for priority and electronic signatures for approver roles. In addition, Review Center in Jama Connect helps teams reduce risk, and save time and money by allowing teams to:
Increase participation in the review process
Retain a historical record of all decisions made and by whom
Provide visibility sooner in the review process
Generate approval-ready content for e-signature faster
Collaborate more often and capture tacit knowledge
Check out the potential savings you could realize with your own numbers using the interactive calculator below!
4. Identifying Defects Earlier in the Development Process
Does your organization build complex software and systems? How much can you decrease the cost of development by addressing software defects earlier? Using a modern requirements management software solution can help you identify and address software defects due to:
Lack of rigor early in the development lifecycle
Low stakeholder participation in requirements definition/validation
Poor visibility into requirements changes and impact analysis
V&V/QA teams remaining disconnected throughout the process
For this sample equation, we’ll take an average total number of requirements managed annually (we’ll use 4,500) and the average number of hours it takes to fix a defect (we’ll use six hours for this example). The average number of requirements with defects typically equals around 60% of the total number of requirements. With these test numbers, the annual cost of defects would be $850,000. Jama Connect can reduce the number of requirements-related defects by 25-40%. Identifying and addressing these issues earlier in the development process can significantly help to reduce risk and reclaim significant budget.
For this calculation, we’ve used 30%. The calculation assumes 237 actual working days per year (at an average salary of $100K) with each author in Jama Connect reclaiming one hour per day.
With Jama Connect, the annual budget that could be reclaimed is $255,150.
Test the numbers for yourself using this ROI calculator to see how much you can save by reducing requirements-related defects by up to 40%!
Let’s face it, if software is difficult to use and the user interface is challenging, engineers just won’t use it, or only a select few will. We all want life to get the job done, run smoothly and easily — and the software we choose needs to reflect those desires. So, the right requirements management software not only needs to be powerful and have robust capabilities, but it needs to be easy to use.
“Jama Connect lowers the complexity and burden of having to manually keep requirements, architecture, and specifications all in sync and traced to each other. It’s a formidable problem that is virtually eliminated courtesy of Jama without the hassle of having to learn a clunky UI (IBM Doors).”
Alan M., Chief Product Officer – G2 Verified Review
“Jama is being used as a test management tool in my company. I [have been] using Jama [for] 3+ years, and I can tell you that this was one of the best Test management tools I’ve ever used. Everything is so easy to understand, and the interface is user friendly — easy to use and can learn this tool quickly.”
Team Lead in Engineering, Software Company – Verified Trust Radius Review
A smooth user experience that provides a pleasant and recognizable interface (one that teams will actually use) is critical to the success and effectiveness of any product development process. Jama Connect is award-winning for its ease of use, and that’s something we’re proud of. Customers love using Jama Connect to optimize their complex product, systems, and software development spanning industries such as aerospace and defense, automotive, medical device/life sciences, financial, semiconductor, insurance, industrial, software technologies, and more.
“Our team cannot stop saying great things about Jama Connect! Its efficiency and intuitiveness have turned requirement workshops from a multi-day event to a 6-hour meeting. Teams adopted the platform so fast, we needed to go back to Jama to get additional licenses (twice)!”
Jim Bolton, Director of Methodology and Tools – Workforce Software
“I told the team it was a very easy-to-use solution. But people were shocked at how fast it came together. Within hours, we were going and setting up the structure for our requirements. There were many other people in the company who had used Jama Connect before and supported our selection. It was a clear choice for medical device innovators like us.”
Rama Pailoor, Vice President of Software Engineering – Proprio
6. Optimizing Communication and Collaboration
Modern, easy-to-use software can improve collaboration and communication across an organization, both for internal and external stakeholders. The right requirements management software will optimize communication and save money, frustration, resources, and time- across the board. One of our customers, the Finnish Red Cross, estimates that their testing team has improved their collaboration and communication by 50% with Jama Connect.
Legacy systems like IBM® DOORS® are notoriously difficult to use and often require individuals with specialized training to implement. This regularly forces engineers and other stakeholders to manage projects outside the software in disparate documents.
“Jama suited our need for collaboration and communication. Jama provides a very easy-to-use interface and communication system that brought in the buy-in from all stakeholders. Visure, Doors, TTA didn’t perform as well in the communication/ collaboration department where we really needed a boost.”
Stephen Czerniej P. Eng, Systems Engineer – Allied Vision
With Jama Connect, broader teams and stakeholders can collaborate on reviews, test cases, verification and validation in real-time. This kind of in-situ collaboration dramatically reduces risk across the entire development lifecycle to reduce the chance of delays, cost overruns, and expensive recalls, and in turn increases the opportunity for successful outcomes.
[Jama Connect] has allowed us to get more people from our other offices involved in the collaboration process because we’re not all having to sit on a conference call at awkward times. People can come into the system at a time that suits them and review things. And we know their comments will be seen by everybody else.”
Alistair McBain, Sr. Business Consultant – SITA
The fact that it is easy to share information and execute processes even when the team is not co-located (geographically dispersed). Changes are properly tracked, and people notified. It is also easy to organize, review, and monitor the review progress. My organization involves several scientists from 31 countries and more than 200 institutes. Jama Connect gets remote and distributed people informed and involved on processes related to requirements.
Francesco D., Senior Systems Engineer – Verified G2 Review
7. Centralizing Your Requirements Management with Best-of-Breed Tooling
Managing requirements in a single platform speeds up the product development process by saving time (time=money), strengthening alignment, and ensuring quality and compliance. Teams can create, review, validate, and verify requirements in one solution. With Jama Connect, teams can:
Have an authoritative source of truth for clear visibility throughout the product development lifecycle
Iterate in real time for informed decision-making and consensus
Support multiple product development methodologies and engineering disciplines
Configure the requirements management software to align with industry best practices
Visualize how tests track back to requirements to prove quality and compliance
Reuse validated requirements to quickly replicate features across products
Not investigating how you can leverage software within your organization is costing you money
“We are using [Jama Connect] from the design specifications/requirements till the test case reviews… Since Jama can be used as a complete project management tool, complete details of a product /project can be tracked in one place easily.”
Suhas Kashyap, Senior Test Engineer, L&T Technology Services – TrustRadius Verified Review
“Jama Connect has brought some new life to our requirements management (and how we see the inter-connectivity of functional requirements with System Requirement Specifications), better dashboards and reporting for everything it supports from printing test plans, requirements, specifications, and test runs.”
Fred Sookiasian, Senior Quality Assurance Software Lead – Advanced Bionics
The #1 problem product engineering organizations face is complying with traceability requirements spanning siloed teams and tools. And one dirty little secret in product engineering is the plethora of traceable data stored in Microsoft Excel. Jama Connect Interchange™ is purpose-built to deliver end-to-end Live Traceability™ (see section below) across best-of-breed tools, including Microsoft Excel — and it’s the first requirements management platform to make Excel data live traceable through a point and click integration interface.
Now teams can leverage the power of Jama Connect’s traceability model to continuously sync traceable information from other best-of-breed tools with no change required for engineering disciplines to continue using their chosen tools to maximize productivity.
“Jama Connect is one of the vital and advanced tools of the modern era. It has a methodology that can ensure complete project tracking from the first step to the execution, test cases, rectification, quality assurance, project timelining, and much more in a streamlined way which has been increasing the overall ROI and efficiency of the project. The important factor of Jama Connect is that all board members can analyze and collaborate on the performance on the same stage, and this has been increasing trust between the clients and organizations while doing large-scale management.”
Engineering Strategist, IT Services – Verified TrustRadius Review
8. Measuring and Improving Development Success with Live Traceability™
Live requirements traceability is the ability for any engineer at any time to see the most up-to-date and complete upstream and downstream information for any requirement — no matter the stage of systems development or how many siloed tools and teams it spans. This enables the engineering process to be managed through data, and its performance improved in real-time.
“Right off the initial stage of just importing the data in Jama Connect and trying to create the relationships, we actually saw that we had traceability gaps, just based on what we had done before in the old system. Catching these gaps would’ve probably taken hours or days in our old system, while with Jama, it became obvious in a matter of minutes.”
Jama Software® is the first to measure traceability thanks to our clients’ participation in a benchmarking dataset of over 40,000 complex product development projects spanning aerospace, automotive, consumer electronics, industrial, medical device, semiconductor, space systems, and more.
“We have achieved: better requirement communication across departments; a better home for verification and validation test cases with traceability to the sources; and a detailed overview of traceability of requirements from regulatory requirements all the way down to risk items.”
Stephen Cxerniej P. Eng PMP®, Global Platform Systems Engineer – Allied Vision
If you’d like to learn more on how to measure your traceability to improve product quality and accelerate time to market — and get your Traceability Score™, check out our Requirements Traceability Benchmark (the first large-scale, empirical research to confirm that higher levels of traceability correlate to cycle time and quality improvements.) In it, we show how higher scores equal improved product quality and faster time to market. examine how traceability is measured, and the business practices that separate top-quartile performers from the rest.
“Jama Connect establishes traceability proactively from user needs, risk controls, all the way through verification.”
Rama Pailoor, Vice President of Software Engineering – Proprio
When asked, “What do you like best about Jama Connect?” One G2 reviewer shared this:
” …Traceability and the traceability matrix. The ability to establish relationship rules, relate items and item types, and then see where you have gaps is really powerful. After your relationships are established, if you make a change to an item, you can see which related items might be impacted. It makes management of requirements extremely easy.”
Marshall K, Senior Vice President, IT Solutions – G2 Verfied Review
To speed time to market, with reduced risk of negative budget impact, now is the time invest in a modern requirements management platform
Jama Connect enables the delivery of high-quality products, faster, by improving the systems development process through unified requirements management and traceability across the V-model (or any product development process you utilize such as Waterfall, Agile, etc.).
“Jama Connect enables a requirements-driven, systems engineering approach for deploying the V-model in product development. It helps us manage the complexities of vehicle hierarchy; interdependencies between vehicle, system & component; and establish traceability between requirements to validations.”
Anirban Niyogi, Systems Engineering Lead, Vehicle Integration – Nikola
The platform’s robust features coupled with an easy-to-adopt interface aligns people, processes, and tooling in one place to provide visibility and actionable insights into the end-to-end product, systems, and software development process. The result — improved product quality and accelerated time to market with reduced risk of costly delays, recalls, rework.
“We save a lot of time and effort in development and product management by using the well-made collaboration functionalities, especially in these current COVID times, when actors cannot always meet in person. We also save time by making use of the item reuse capabilities of Jama. With Jama we always know who made changes to an item, when the changes were made and sometimes even why. That helps us tracking down and understanding those changes. The ability to link pieces of information together in a relatively easy way, help us to achieve full test coverage, checking for impacts of changes upfront and oftentimes understand a requirement’s rationale. Jama [Connect] also provides good filter and search functions and especially the weaved in collaboration functions constantly prove to be useful. It is also worth mentioning that Jama [Connect] provides powerful customization options, so we were able to customize Jama to our needs and way of working.”
Olaf P., Requirements Management Enterprise – Verified G2 Review
Is Now the Right Time to Invest in Requirements Management Software?
Understandably, being on the edge of a possible recession can motivate extreme fiscal prudence, but now is not the time to duck and cover. It’s the precise time to make proactive decisions that will save your organization measurably in the long run. If you’re dealing with any of the budget-swallowing inefficiencies mentioned above — and can see the potential gains a modern requirements management solution like Jama Connect will offer — it might be exactly the right time to strategically think about making a change to optimize your development processes, saving money for your organization in the long run.
“We have achieved a significant ROI with Jama Connect in risk reduction and productivity gains: reuse is up 100%, rework is down 50%, requirements review cycle time is cut by 30% and audit preparation time is down 75%. Jama Connect is our single source of truth. If it’s not in Jama Connect, it’s not happening.”
Kurt Shuler, VP Marketing – Arteris IP
Are you ready to reclaim some significant budget? Give us a call to see how we can be of help or get started today with a free trial of our award-winning requirements management software platform.
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Why Investing in Requirements Management Software Makes Business Sense During an Economic Downturn
Regardless of the state of the economy, organizations building complex products, systems, and software can always benefit from improved efficiency across the end-to-end development process. Making strategic changes that optimize processes and team productivity will undoubtedly save your organization significant time and money.
And, while it may seem counter-intuitive to invest in new technology during an economic downturn (dare we say the word recession), a modern requirements management tool like Jama Connect®, can provide a dramatic ROI in short order — making it a smart-sense move to invest in new product development software right now.
During economic uncertainty, spending capital on the right tools can improve product quality and increase productivity, well-positioning your organization to save time and money over the long term. But regardless of what happens with the economy, it is never going to be wasted effort to optimize your product development processes or begin to think about how to weather the impact of an impending economic storm.
Invest in Requirements Management Software Now to Save In Both the Short & Long Term
Many of our clients come to Jama Software to help optimize their product development process after experiencing some of the following core frustrations:
Using cumbersome legacy requirements management solutions that have non-intuitive challenging UI/UX
Engineers spending valuable hours of tedious manual documentation across disparate documents and tools
Engineers wasting time on in-efficient workflows that can be streamlined to save upwards of 80%
Insufficient, ineffective cross-team collaboration across various stages of the systems development process starting from requirements, design, development to testing and validation
Inefficient and cumbersome review cycles
Difficulty in easily producing the necessary documentation to prove compliance
Siloed tools and processes that misalign teams and workflows, and leave visibility gaps
Lack of Live Traceability™ which results in finding errors late in the development process which can cost upwards of 100x or more to resolve than if they had been found earlier in the development process
And the list goes on and on…
Think about the corresponding monetary burden these outdated solutions and misaligned processes place on the organization’s shoulders.
Making an investment in a modern requirements management platform isn’t simply about the time and money that will be saved or improving productivity and efficiency for just a few months — it’s about the savings and reduced re-work that will be realized from the moment the application launches and for years beyond. Depending on the organization’s goals, they either save costs with the gained efficiencies or they use it to be competitive, win new contracts, and bring products to market faster and more cost effectively. You may be thinking that now is the time to pause on spending, not invest. To the contrary, we’d like to share how investing in a modern requirements management solution now is the right decision to help your organization protect itself from an economic downturn and increase your ROI.
For Startups: Build Your House on Bricks, Not Sticks
For startups, investing in a modern requirements management solution, like Jama Connect, is a smart idea irrespective of the state of the economy.
While long established large organizations may be able to withstand a period of lowered sales and slow development, startups may not have that option. A startup’s ability to get to market fast – and first – often is a great indicator of success, and on the flip side, failure.
Doing things right the first time is crucial.
While startups might be hesitant to invest in software initially, a great number are investing in Jama Connect in order to reduce rework, speed development, meeting regulatory compliance, and get to the market before their competitors.
And it’s paying off.
For medical device startup, Proprio, VP of Software Engineering, Rama Pailoor knew it was imperative to establish a requirements-driven development process from the very beginning. Pailoor recognized that their existing approach of using only a Quality Management System (QMS) was not capable of supporting the level of complexity needed to develop their product. Like many document and spreadsheet-based processes, the Quality Management System (QMS) Proprio had in place technically supported requirements management at face value, but when it came to complex engineering efforts, the system came up short.
“Establishing a requirements-driven development process helps to formalize the user needs, getting all the stakeholders to come to a common forum, to express the requirements from their perspective, and avoid confusion. The right requirements management solution can facilitate all of that.”
Rama Pailoor, Vice President of Software Engineering – Proprio
For medium to large organizations: Strengthen your foundation by investing in modern tools and digital transformation
While big enterprises have large teams spread across various geographies and different divisions working on multiple projects, there is a strong need to optimize processes and reduce inefficiencies to reduce costs — especially during challenging economic times. Putting resources towards digital transformation and modern software tools (which result in more ROI) will also reduce overall product development costs over the long term. Through these investments, companies can strengthen their foundation to remain competitive and be better able to weather external market forces.
It is also worth re-visiting how enterprises can improve the engineering efficiency of product development by investing in requirements management and traceability tools. Optimizing the systems engineering process by bringing in traceability across your development stages can immediately create a positive impact on cycle times, and faster execution of testing and validation.
Requirements management software, like Jama Connect, can help development teams improve product quality and accelerate time to market. The platform’s robust features coupled with an easy-to-adopt interface aligns people, processes and tooling in one place to provide visibility and actionable insights into the end-to-end product, systems, and software development process.
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Jama Connect Interchange™: Live Traceability™ Realized
The #1 problem product engineering organizations face is complying with traceability requirements spanning siloed teams and tools. Organizations are often encumbered by the highly manual and time-consuming review of information across numerous spreadsheets.
What is Live Traceability?
Jama Software defines Live Traceability ™ as the ability to see the most up-to-dateand complete upstream and downstream information for any requirement, no matter the stage of systems development or how many siloed tools and teams it spans.
This enables engineering and product management processes to be managed through data and to improve performance in real-time.
How Can We Extend Live Traceability using Jama Connect Interchange?
Jama ConnectInterchange™ is purpose-built to deliver Live Traceability across siloed teams and best-of-breed tools, including Microsoft Excel. By using Jama Connect Interchange, teams can simplify this process by linking data across multiple product development applications.
Best-of-Breed Tools That Plug into Jama Connect for Live Traceability
By utilizing Jama Connect Interchange, teams can now leverage the power of Jama Connect’s traceability model to continuously sync traceable information from other tools with no change required for engineering disciplines to continue using their chosen tools to maximize productivity.
To stay up-to-date on future integration tools available with Jama Connect Interchange, follow the Release Notes in our Community!
The Key Benefits of Jama Connect Interchange
Live Traceability
Overcome siloed information to support your product development lifecycle from user and market needs to verification and validation.
Data Integrity
Run complex calculations, logic statements, and other Excel operations from within Jama Connect. All standard Excel functions are supported, and values flow automatically, so you can utilize the full power of Excel without leaving Jama Connect.
Speed
Align teams, track decisions efficiently, and minimize rework to create high-quality products on time and on budget.
Adaptability
Easily adapt Jama Connect to your project and organizational workflows to create an intuitive experience so your teams can get up to speed quickly.
Requirements in a Single System of Record
Achieve and maintain alignment with real-time updates across teams and tools in a single location.
Common Jama Connect Interchange Use Case
Configurable Sync
One-way or bidirectional sync to match your workflows; set the sync frequency to match the speed of your business
Rich Data and Formatting
Supports text formatting, tables, bullets/ numbering, and text transformation
Simple Configuration
Quick setup wizard, control panel, and field mapping tools – all backed by auditable logs
Unlike other solutions in the market, Jama Connect Interchange has been specifically designed and developed to work seamlessly with Jama Connect. It’s easy to deploy, configure, use, and expand – driving efficiency and further lowering your total cost of ownership.
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Jama Software® Enables Measurable Performance Improvement with Client-Specific Success Paths
We’re excited to announce our further advancement to our market-leading customer success program that has led to high levels of customer retention and award-winning customer satisfaction. Our customers are now able to define measurable success paths from a catalog of consulting offerings to derive optimum and continuous value from Jama Connect®. The new Jama Software Success Program helps customers accelerate the best possible business outcomes and realize long-term success.
With the Jama Software Success Program, customers can now select the success path that best maps to the level of collaboration required to meet their unique needs and desired business outcomes. These customizable success paths deliver the industry-specific expertise, guidance, and resources clients need to see a quick return on investment and achieve their goals.
The Jama Software Success Program has three primary offerings:
Essentials Success – A foundational self-guided success path with access to key resources, tutorials, and training to set customers on the road to success.
Guided Success – A guided success path with enhanced resource offerings including benchmark assessments, personalized training offerings, and technical services to help evaluate compliance and improve process and quality.
Strategic Success – A strategic success path which provides even more advanced offerings, premium-level support, and a close partnership in complex and ongoing enterprise deployments to drive continuous process improvement across multiple projects.
To learn how Jama Software enables your company to succeed in a competitive market, CLICK HERE
With in-house industry experts, extensive consulting, training, and data-driven insights to measure and improve outcomes, the Jama Software Success Program enables customers to accelerate development, improve product quality, reduce risk, and manage innovation in systems engineering.
“With this program update, Jama Software now provides best practice engineering process improvement,” stated Tom Tseki, Chief Revenue Officer. “While other software companies are focused on just implementing their solutions, Jama Software is focused on providing measured process improvement for our customers that goes way beyond just the implementation of software.”
Live Traceability™ for Airborne Systems Development
Airborne systems are incorporating more cutting-edge technology and becoming more complex with advanced embedded computing technologies, electric propulsion systems, sensors and data, and airframes. A major percentage of this complexity is handled at the software level. Any error in the avionics software of safety-critical airborne electronics could be catastrophic to the aircraft, its occupants, or persons on the ground.
Airborne systems development requires developers to adhere to the most rigorous safety standards in the world. These extremely rigorous, plan-driven, development processes are unimaginable to developers who have not done it before. Certification is expensive. Delays in certification due to lack of evidence of following mandated guidelines could spell the demise of a new startup. Mistakes in design and development could cost lives. Manual documentation or the use of legacy tools introduce risk. Achieving certification for safety-critical airborne software is costly and time consuming. Once certification is achieved, the deployed software cannot be modified without recertification.
Airborne certification bodies such as the Federal Aviation Agency (FAA) and European Aviation Safety Agency (EASA) recognize international standards as “acceptable means, but not the only means, for showing compliance with the applicable airworthiness regulations for the software aspects of airborne systems and equipment certification.” The most common standards that are followed for airborne systems as a means of compliance are: RTC DO-178C (also published in Europe as EUROCAE ED-12C), DO-254 (also published in Europe as EUROCAE ED-80), and SAE 4754A (also published in Europe as EUROCAE ED-79) standards for Airborne systems.
Demonstration of traceability is fundamental to each of these standards as the evidence mechanism to demonstrate that safe design practices were followed. Jama Connect provides an efficient way to capture traceability in a “Live” manner as artifacts (requirements, tests, risks etc…) are being created. Manual document methods and legacy tools will require engineers to create the trace relationships after the development has been done. This could introduce risk as well as lengthen development times.
Traceability models assist users to create consistent traces between data, then query that data, and provide consistent trace nomenclature between different tools in the ecosystem. The standards are where to begin when defining a traceability model for airborne systems. For example, ARP4754A/ED-79 describes the identification of requirements at the aircraft level, system level, and at an item design level. These requirements interact and are “traced” to various safety related data as well as verification tests. In Jama Connect data artifacts called item types are defined to capture this data and a relationship ruleset is put in place to govern the traces and provide the facility to analyze and report on the traces.
ARP4754A process interactions between safety and development.
In Jama Connect data artifacts called item types are defined to capture this data and a relationship model is put in place to govern the traces and provide the facility to analyze and report on the traces. In the figure below the relationship model that Jama Connect automatically draws for you, the item types are: Function, Failure Analysis, System Architecture, System Requirement etc. The traces relationships are depicted as the lines between the items types.
The airborne systems software standard DO-178C/ED-12C requires a “documented connection” (called a trace) between the certification artifacts. In the figure below from DO-178C, users must document traces between system requirements and high level software requirements (HLR). HLRs must be traced to software low level requirements (LLR) as well as test cases and software architecture. LLRs must be traced to test cases and source code.
For example, a Low Level Requirement (LLR) traces up to a High Level Requirement (HLR). A traceability analysis is then used to ensure that each requirement is fulfilled by the source code, that each requirement is tested, that each line of source code has a purpose (is connected to a requirement), and so forth. Traceability ensures the system is complete. The rigor and detail of the certification artifacts is related to the software level.
DO-178 mandates requirements-based testing. Each requirement must have associated tests exercising both normal processing and error handling, to demonstrate that the requirement is met and that the invalid inputs are properly handled. The testing is focused on what the system is supposed to do, not the overall functionality of each module. In figure X the Jama Connect traceability model demonstrates this end to end traces from aircraft functions, to system level, and lower level software as well as the verifications covered in all of the standards
In addition to requirements to test coverage demonstration, the airborne systems standards call for bi-directional traceability between code and requirements. The source code must also be completely covered by the requirements-based tests. “Dead code” (code that is not executed by tests and does not correspond to a requirement) is not permitted. Jama Connect’s Live Traceability allows for connections to other tools in the ecosystem that engineers are using to perform these activities such as testing tools such as LDRA Tool Suite and SW configuration management tools such as Git. The LDRA tool suite is a flexible platform for producing safety, security, and mission-critical software in an accelerated, cost effective and requirements driven process. The tool suite’s open and extensible architecture integrates software life-cycle traceability, static and dynamic analysis, unit test and system-level testing on virtually any host or target platform. Finding the dead code using LDRA makes this an easy task. The figure below describes an example of a best of breed tool ecosystem facilitated by Live Traceability.
Jama Connect’s Live Traceability supports capabilities to both continuously sync data between tools in the ecosystem or display the live linked data within the UI. Organizations may require one or both use cases to support their digital transformation efforts. Tools like Syndeia from Intercax can easily make use of Jama’s Live Traceability to perform synchronizations as well as provide services to author, query, visualize, and curate open digital threads.
Live Traceability performs a crucial role when it comes to review. DO –178 calls for, and is required for the higher DAL levels, what is called “transition criteria.” Essentially this means that reviews of the traceability itself must be demonstrated. Jama’s Review Center streamlines this by displaying the up and downstream traces right in the context of the review.
Airborne systems have far more onerous governance and compliance hurdles than other industries such as automotive, finance, or medical. The standards require evidence that traceability evaluations were performed. Traceability evaluations must also be independently assessed by four successive levels of traceability assessments: 1) engineering author, 2) an independent engineering reviewer, 3) a software quality assurance auditor, and lastly, 4) a certification liaison reviewer from FAA or EASA.
At the end of the day, Airborne Systems developers must provide evidence of compliance to the certifiers. Live Traceability provides the ability, for the first time, to manage by exception the end-to-end airborne design assurance process across all engineering disciplines. The traceability model defines required data traces called for by the standards that can be compared to actual activity to generate exceptions. These exceptions are the early warning indicators of issues that most often lead to delays, cost overruns, rework, defects, and certification deficiencies.
The benefits of using Live Traceability in airborne systems development within Jama Connect and across a tool ecosystem are as follows:
Proves Airborne Systems compliance articulated in the industry standards in real time without the need to create traces after the fact and enhances the visibility that the defined process is being followed.
Provides simplified project estimates, reduces the risk of delays, cost overruns, rework, defects, and recalls with early detection of issues through exception management, and saves 40 to 110 times the cost of issues identified late in the process.
No disruption to engineering teams that continue working in their chosen best-of-breed tools with no need to change tools, fields, values, or processes.
Increase productivity and satisfaction of engineers with the confidence that they are always working on the latest version, reflective of all changes and comments.
https://www.jamasoftware.com/media/2022/03/Live-Traceability-for-Airborne-Systems-Development-Blue-1.png5121024Cary Bryczek/media/jama-logo-primary.svgCary Bryczek2022-03-17 03:00:372023-01-12 16:47:32Live Traceability™ for Airborne Systems Development
Systems Engineers Career Path
Most Systems Engineers we speak with have a common perspective on their role within their organization. Systems engineering as a concept is understood and supported by leadership. And, if systems engineering best practices are followed across all engineering disciplines, leadership also acknowledges the benefits the organization can realize. However, leadership will not force change on engineering disciplines (software, hardware, electrical, risk, verification, and validation) to remove barriers to systems engineering best practice adoption. This leaves most Systems Engineers in the challenging position of possessing responsibility for achieving systems engineering benefits without the authority to ensure engineers adopt best practices.
The good news is that there is a way out of this situation. The first step to elevating your career is to realize that managing the product engineering process through data is the key and that the Systems Engineering role is the natural role to lead this. For most organizations, the product engineering process is the only process in the company that is not managed through data. No one can go to a system and see the status of all product requirements and where development, integration, risk, and testing stand at any point in time. There is no way to manage by exception. There are no alerts that requirements are not covered, test cases are missed or that hardware made a change that now impacts software. Most organizations have come to accept this state of affairs and try to manage the process through endless meetings, emails, and Slack messages.
Until the product engineering process is manageable through data, Systems Engineers will be stuck in their current trap — endlessly trying to address issues after the fact, holding unwanted meetings, and the uphill battle of trying to persuade changes in behavior. Below is a 3-step approach that Systems Engineers we work with have used to solve this organizational challenge and have thereby elevated their careers. As with any process change, it is best to do it in stages. You can start with the following steps.
Baseline current process performance
Build the business case for change to gain support
Step One | Baseline Current Traceability Performance
The first step towards moving the organization to manage the product engineering process through data is to baseline current process performance. The best place to focus the baseline effort is on traceability since it spans the entire product development process, is a data management concept that is understood, enables systems engineering benefits, and is required by industry standards. To ease the baselining effort, we’ve developed a Traceability Diagnostic that you can use to assess your current situation. The Diagnostic inventories traceable data, the systems in which they reside, and your current Traceability Score™. This is a few-hour effort and forms the basis of the business case in step two.
In this no-cost, guided process, we’ll help you:
Understand the monetary risk of your current Traceability Debt™
Uncover the quantifiable ROI of moving to Live Traceability
Develop a clear plan of action, cost, and timing to achieve Live Traceability
To Get Started With Your Free Traceability Diagnostic, CLICK HERE
Step Two | Build Business Case for Live Traceability™
Once you have established a baseline, it is now possible to build a business case for change that will resonate with leadership. Based on your baseline, the Traceability Diagnostic determines the probability of negative product outcomes (defects, delays, rework, cost overruns, etc.) and the magnitude of these events. This quantifies the risk of maintaining the status quo and doing nothing. In addition to the risk reduction potential of Live Traceability, the Diagnostic also calculates the engineering productivity gains from eliminating the need for time-consuming, manual, after-the-fact traceability efforts.
Step Three | Start with Quick Wins
Once you have secured support to move forward, it is common to be able to deliver some quick wins to the organization shortly after project kick-off. The typical place to start is the painful and time-consuming after-the-fact traceability efforts. For example, continuous syncing between requirements and software development task management in Jira or Azure DevOps can be set up quickly to automate traceability from requirements to user stories, eliminating a large source of risk and manual, after-the-fact traceability effort. Once quick wins are shown, organizational momentum increases even further and puts you on the success path to begin managing the product engineering process through data.
Clients of ours that have taken this approach have received significant recognition, been promoted into roles with greater leadership, and have increased their external visibility through speaking engagements. Live Traceability is a unique opportunity to elevate one’s career. Don’t miss the chance.
https://www.jamasoftware.com/media/2022/01/2022-01-21-systems-engineer-career-path-how-to-elevate.jpg5121024Marc Osofsky/media/jama-logo-primary.svgMarc Osofsky2022-01-28 03:00:402023-01-12 16:47:41Systems Engineers Career Path – How to Elevate
Live Requirements Traceability
Achieving Live Traceability™of product requirements, as necessitated by industry standards, across siloed engineering teams and tools, is the #1 unsolved problem for most product development organizations. One of the main barriers is that each engineering discipline (systems, software, hardware, electrical, risk, verification and validation) has optimized its own process and tools. When looking at the end-to-end product development process siloed teams, tools, and data make it very challenging to trace development activity from initial requirement definition through development and testing.
As a result, requirements traceability becomes a time-consuming, error-prone, frustrating, and manual, after-the-fact process. The inability for the product development organization to continually trace ongoing development efforts and changes back to user and system requirements results in missed requirements, defects, rework, delays, audit letters, and cost overruns.
The typical approach to solve this generic process problem with software is to force every user onto a single platform and follow one common process. This works for standard business processes in HR, Sales, and Finance, but engineering disciplines across systems, software, hardware, electrical, risk, test, verification, and validation each follow different methodologies and use multiple tools including spreadsheets, desktop, and homegrown applications. Each engineering discipline has optimized their own development environment and strongly resist any attempts to change. Engineering leadership defers to each engineering discipline to define how to best do their work and is loath to dictate processes and tools that will negatively impact the performance and morale of each engineering team.
In addition to the organizational barriers to standardization, no single platform is even close to currently existing which replaces these dozens of tools. A single platform would need to cover all of the following software categories AND address all functionality in spreadsheets (Excel), scripts, desktop, and homegrown tools: Requirements Management, CAD, MBSE, DFMEA/FMEA, software task management, software code management, automated software testing, hardware bench test tools, ALM, PLM, and more. Current efforts by legacy vendors to create a common SaaS platform to span all these software categories and reach parity with best-of-breed tools is moving very slowly.
How to achieve Live Traceability™ without forcing change on engineering teams
So how does an organization achieve Live Traceability across a best-of-breed tool environment supporting disparate methodologies, terminologies, fields, and statuses? The answer is a 3-step approach:
Step One | Live Traceability Model
Define a Live Traceability model across the end-to-end product development process with relationship rules for the traceable data elements across best-of-breed tools. An automotive functional safety example is shown below. Here you can see the operational instantiation of functional safety standards requirements in a relationship model within Jama Connect®. All necessary traceable information is included with continuous syncs to best-of-breed tools within engineering teams to deliver Live Traceability.
Step Two | Adaptive Data Field Mapping
To achieve Live Traceability, integrations with best-of-breed tools (such as those shown in the example) are required. The typical integration approach standardizes field names and statuses to ensure consistency across the connected tool, but this does not achieve the dual objective of Live Traceability with no changes required in how each engineering team works. Alternately, the proven approach is to apply adaptive data field mapping to ensure no change to engineering teams’ fields and statuses which simultaneously ensures a consistent, process wide, Live Traceability model. This is achieved through robust mapping and normalization logic functionality to easily address the various approaches taken by each engineering team.
Once Live Traceability is achieved, engineering organizations can — for the first time — manage the end-to-end product development process in real time, identify exceptions to the process early, and take action to significantly reduce defects, rework, delays, and cost overruns.
LEARN MORE
https://www.jamasoftware.com/media/2022/01/2022-01-14-overcome-barriers-to-requirements-traceability.jpg5121024Marc Osofsky/media/jama-logo-primary.svgMarc Osofsky2022-01-14 03:00:212023-01-12 16:47:44How to Overcome Organizational Barriers to Live Requirements Traceability
In this blog post, experts from Cadence, OpsHub, and Jama Software talk about enabling digital transformation in the hardware and semiconductor industries.
The relentless pace of innovation, rapidly changing markets, and increasing product complexity are creating intense pressures on companies in the semiconductor and hardware space. Some of the biggest challenges relate to scaling effectively and efficiently within the context of digital transformations.
Organizations in all sectors are looking to support faster release cycles and accelerate innovation. Siloed and legacy tool chains create a major hurdle in accomplishing these goals.
Watch the webinar or read the recording to learn more about:
Rich collaboration
Complete traceability
Full transparency among all stakeholders
Faster releases
Improved quality and productivity
Below is an abbreviated transcript and a recording of our webinar.
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Jama Connect: the Leading Platform for Requirements
Matt Graham: Thanks everybody for joining. So today, before we get into the agenda just to introduce the three products that there are three subject matter experts about. First of all, something near and dear to my heart, the Cadence vManager, verification management platform which is a scalable, reliable and very feature rich verification planning and management solution from Cadence. That sits on top of a number of our verification and provides a sort of roll up capability. And we’ll describe it in a little more detail in a couple of slides. On the OpsHub opposite side, we’ll be looking at the OpsHub integration manager that enables enterprises to integrate their best of breed tools together that are best suited for the various teams and their various roles and connect those two together for integration and collaboration. And then Jama Connect, which is the leading platform for requirements, risk and test management to help provide that sort of end-to-end compliance solution.
Our agenda today. First we’ll look at some of the challenges of the semiconductor and hardware development ecosystem. This is obviously a very fast paced, highly competitive type of environment and there’s a lot of specific challenges that the integration of the tools I just mentioned can help address and solve. We’ll look at how engineers in this space can scale effectively and efficiently utilizing some of these, the tools to address some of the ongoing transformations in that space. And then specific to semiconductor domain, bridging the gap in what has historically been a very siloed development process. And bringing together for efficiency, quality and reliability all of the various tools that I mentioned and giving it a really nice integrated development and verification environment. We’ll then have a specific use case and demo showing how the three tools work in concert and then look at some key takeaways. And as Marie mentioned, some Q and A.
Standards for Requirements such as ISO 26262
Specifically to the semiconductor and hardware ecosystem, there are a developing set of challenges. And of course they’ve always been challenges in this area. First pass design success is critical for hardware development. Just because the tooling costs are so great. We don’t want to have to respurn hardware. It’s not like just releasing more software. It is it requires expense. But that has been the way of hardware development for some time. In the last several years we’ve seen a need creeping into that environment for even stricter compliance, particularly around mission critical domain such as aero and defense, automotive especially as self-driving and autonomous vehicles come in. And adherence to standards like ISO 26262 presents another layer of requirements and need for management and collaboration on top of an already strict set of sort of design parameters.
As I mentioned, this development environment tends to be very siloed in its nature because it is so specialist. You have specialist designers, specialists verification engineers to test the designs, specialists post silicon, specialists layout engineers and so on and so forth. And all of those silos, well somewhat required of the specialty of each of those tasks tends to hinder collaboration, compromise quality and just impact efficiency and velocity overall. In an area where efficiency and quality is critical. We can’t have bugs in semiconductors going to automotive and we need to be able to turn those new cell phones, those new mobile devices as quickly as possible. So turnaround time is just getting compressed and the requirement for quality is increasing at the same time.
All of that sort of siloed nature of the specialties as well as the need for velocity and quality really ends up in poor traceability of results in terms of compliance and quality issues creeping in. Especially when it comes to doing things like audits for ISO and other similar standards that are becoming the requirement across again aero and defense type applications, automotive type applications and even down into the sort of consumer device applications. And really traceability is a watch word now in the ecosystem of hardware and semiconductor development.
So how does the offering from Cadence, vManager fit into and help provide a solution to those challenges that I just mentioned? Well, for a number of years now, in fact, vManager has been around for about 15 years and in that entire time it’s had the key capability of the verification plan. And the verification plan really exists to provide traceability between what is being executed during the testing or verification of your semiconductor or hardware design. And what were the goals of that or the requirements of that testing or verification project. Things like testing interfaces, both internal and external to the semiconductor, testing compliance with standards like ethernet and USB, such as that, things like that. As well as the internal requirements of the device, it must route packets this fast. It must answer phone calls in this manner or whatever it might be.
And the verification plan in vManager really allows the user to enter those requirements and then connect them to the real results that are occurring. We ran these tests, these tests were associated with a given requirement. Those tests passed therefore the requirement is satisfied. And so the V plan becomes a very natural place. And in fact the appropriate place to connect the rest of the ecosystem via OpsHub, two tool requirements coming from Jama Connect so that we can have traceability across the software development, the hardware development, whatever. The mechanical development et cetera ecosystems. And the vManager and the verification plan is really where that hardware verification, that hardware and semiconductor development information enters that ecosystem through the conduit of the verification plan. So let’s look a little bit more on, well what exactly is in that verification plan that vManager provides.
Enabling Digital Transformation: Static Documents Cause Challenges
And the V plan is really what we call, what we refer to in our vManager sort of pitch if you will as an executable verification specification or an executable verification contract. And what that means is that there’s data incoming to that during the creation, the authoring of that verification plan. Not only through connectivity to tools like Jama but also from say static documents like standards specifications, ethernet that I mentioned before, USB those are standard protocols that have very lengthy standards documents and needs to be a way to import, kind of gather the data from that and put it in the verification plan. Another input to the verification plan is other verification plans. So if you think about a system on a chip that is not a single piece of intellectual property, it’s built up of many, many different pieces, a USB piece, a central processing piece, a memory management piece and so on.
And each of those pieces can have their own verification plans for the verification at that sort of lower block level as well as then can sort of conglomerating or aggregating those verification plans into a single sort of system on a chip verification plan. And the vManager, V plan allows that through sort of parameterization and instantiation and really flexible set of sort of reuse capabilities for verification lands. And then of course just engineers authoring their verification plan. Literally writing, typing in here’s a specific requirement et cetera. And then we have the component of mapping those requirements to items that exist in the actual testing environment. Things like we have a test, did it pass or fail? What requirement is that test related to? So there’s mapping the test to a particular requirement and then did that test pass or fail. Those of you familiar with hardware verification know that tests passing and failing is not the only statistic or metric that we track.
There’s other metrics and statistics such as code coverage, functional coverage, assertion coverage, software coverage, all tracking what scenarios and what stimulus were driven to the specific device under test. And what was the reaction of the device under test? And then what percentage of the device has been exercised during that test? It is all basically statistics gathering from the testing effort. All that data can be mapped into the verification plan, directed to the specific requirement or multiple requirements that it may satisfy. And of course, this gives us the ability to not only specify a requirement, but then capture whether that requirement was met. Was it satisfied? And this is the place where I’ll hand over to Jeremy now to talk about what those requirements in those higher level requirements or system level requirements in the general world and how they’re going to connect into this hardware verification, hardware development world.
https://www.jamasoftware.com/media/2021/10/WB-2021-10-20_Enabling-Digital-Transformation-OpsHub_Social-Image.png5121024Jama Software/media/jama-logo-primary.svgJama Software2021-10-19 03:00:572023-01-19 12:50:19Enabling Digital Transformation in the Semiconductor and Hardware Space
Design Controls have been an FDA Quality System Regulation since 1997. Having worked on developing products in the regulated medical device industry for over 35 years, I have compiled a list of the five key takeaways for implementing design controls and achieving success in commercializing medical devices:
Design Controls not only help achieve regulatory compliance, they help develop better products
Design Inputs lay the foundation for product development, building a good foundation
Don’t underestimate the power of Bidirectional Traceability
Know the difference between Verification and Validation
Risk Management is a vital part of Design Controls
#1 – Design Controls not only help achieve regulatory compliance, they help develop better products
Many companies think that design controls are a burden to development organizations imposed by the FDA, and it’s the price to pay for playing in the medical device field. However, what is often overlooked is that design controls only define the basic minimum requirements necessary to develop a product that can…
…meet the needs of the user.
…be designed to be safe and effective.
…be reliably manufactured.
…be verified and validated.
…maintained and updated throughout the product lifecycle.
These are all things that any development organization should do to successfully deliver products to market. I like to say that if you are doing the right things in product development, compliance comes for free!
#2 Design Inputs lay the foundation for product development, building a good foundation
The FDA defines design inputs as the physical and performance requirements of a device
that are used as a basis for device design. To generate adequate design inputs, the foundation upon which product development is built, the user needs must first be well understood. These needs, ideally written with the voice of the user, must then be translated into design requirements. In contrast to the user needs, these design requirements should be written using the voice of the engineer, and as such should be measurable and testable. Furthermore, design requirements should be traceable to a specific user need, risk control, or standard that necessitates the existence of said design requirement.
Research has shown that, on average, companies that are successful at developing products spend about 25% of the product development time on the generation of user needs and the subsequent design requirements. The return on this investment of time and resources reduces the need for rework and redesign, and ultimately leads to higher customer satisfaction. Failing to make the investment ensures that design inputs are complete and correct is analogous to building a house on quicksand, where the flaws in the foundation can cause issues throughout the construction and subsequent (likely short) lifetime of the house. Issues with requirements will impact development, verification, validation, and user acceptance of the product, so spending the time to get requirements right will be well worth the effort.
#3 Don’t underestimate the power of Bidirectional Traceability
In an audit, the trace matrix should be valued as a friend! Having and maintaining bi-directional traceability throughout the product lifecycle provides a number of benefits:
Effecting project tracking
Thorough change impact analysis
Ease of making future changes
Re-use of elements of the design
More effective issue resolution
To derive these benefits, the relationship between the following entities should be established:
User Needs and Design Requirements
User Needs and Validation
Design Requirements and lower-level requirements
Design Requirements and Verification
Lower-level requirements and verification
Lower-level requirements and Design Outputs
Risk Controls and Design Requirements
In creating a trace matrix that has views to show all the bi-directional relationships of each of the elements described above can help answer most questions from an auditor. With this level of traceability, I can trace from a user need all the way through implementation and test.
#4 Know the difference between Verification and Validation
The terms “Verification” and “Validation” often get combined and abbreviated to V&V; however, these activities are vastly different.
Verification is confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. It is design-centric and answers the question “Did I build the product right?” Verification also entails gathering objective evidence that the design behaves as intended through the use of observation (visual inspection), measurement (values and tolerances), testing (function) or analysis (reviews).
Validation is confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled. Unlike Verification, this is a user-centric term, and answers the questions “Did I build the right product?” and “For whom is this the right product?” Validation entails gathering objective evidence that the design satisfies the user needs through the use of Usability Studies/Human Factors Studies, Clinical Evaluation/Clinical Studies, Customer Surveys, and through Analysis of Verification Data.
Knowing the difference between Verification and Validation is of quintessential importance for ensuring customer satisfaction and regulatory acceptance of the product.
#5 Risk Management is a vital part of Design Controls
The elements of design controls are Planning, Design Inputs, Design Outputs, Design Reviews, Design Verification, Design Validation, Design Changes and the Design History File. So, what happened to Risk Management? Risk is mentioned in Design Control Regulation (QSR 820.30) all of one time, under Design Validation. The statement simply reads “Design validation shall include software validation and risk analysis, where appropriate.”
Fortunately, the FDA Design Control Guidance elaborates on requirements for risk management. The guidance includes this paragraph:
Risk management begins with the development of the design input requirements. As the design evolves, new risks may become evident. To systematically identify and, when necessary, reduce these risks, the risk management process is integrated into the design
process. In this way, unacceptable risks can be identified and managed earlier in the
design process when changes are easier to make and less costly.
The takeaway from this is that although risk management is just cursively mentioned in the QSR Design Control regulation, the intent of the regulation is that Risk Management be practiced starting from the point where design inputs are known and practiced throughout the product life cycle. You cannot be compliant to the design control regulation without having an adequate risk management file.
Conclusion:
Design Control regulations have been around since 1997, but many manufacturers still have problems complying with design controls. Focusing on the best practices outlined above will derive the most benefit from implementing Design Controls, will lead to a more predictable development cycle, and ultimately result in higher-quality products that can be enhanced and maintained throughout their lifecycle.
https://www.jamasoftware.com/media/2021/09/2021-10-07-five-key-design-control-pracitces_1024x512.jpg5121024Mercedes Massana/media/jama-logo-primary.svgMercedes Massana2021-10-07 03:00:322023-01-12 16:48:01Five Key Design Control Practices that Improve Compliance and Help Develop Better Products