Tag Archive for: modern traceability

Tag Archive for: modern traceability

Audit Trail

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

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

Audit trails are integral to regulatory compliance in industries ranging from medical device manufacturing to automotive production. But what’s the best way to build an audit trail that stands up to scrutiny?

Building a solid audit trail all starts with live traceability.

Why Live Traceability™ is Necessary

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

In 2019, there were 50 medical devices recalled by the FDA — the most since 2014. Among other purposes, an audit trail helps strengthen product development controls and in turn curb the risk of recalls.

The top three reasons for recalls throughout the 2010s were device design flaws, software issues, and defective production processes. Audit trails document how such problems emerged. But too often, audit trails are assembled after the fact, without live traceability. Information may be pulled from numerous discrete documents, such as spreadsheets with hundreds of outdated entries. In contrast, live traceability happens along the way, adding supporting context for data relationships and contributing to better decision-making and future planning.

Live traceability makes it possible to both manage and respond to change in a systematic, auditable, and confidence-enhancing way. In our new infographic, we examine the ways that live traceability allows teams to build an audit trail.

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

Modern Product Development Requires Live Traceability™

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

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

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

Download the full infographic to learn more about building an audit trail through live traceability.

SEE FULL INFOGRAPHIC

requirements managementEditor’s Note: This post about moving beyond legacy systems for requirements management was originally published here on DevOps.com May 12, 2020, and was written by Josh Turpin, Chief Product Officer at Jama Software. We’re always proud to share great thought leadership and this informative post from one of our own is no exception!

Getting Past Legacy Software Pains in Requirements Management

If you feel like you have outgrown your requirements management (RM) software, you are far from alone. From complex systems, such as IBM Doors, to document-based tracking through Microsoft Office, legacy RM tools are having a hard time catching up to the innovation occurring in highly-regulated industries. As we see the line between hardware and software become increasingly blurred, development methodologies are evolving faster than ever before. Sometimes, these changes happen day-to-day or even hour-to-hour, making project traceability feel impossible.

No matter how complex the software or notable the reputation, RM providers don’t always deliver a system that matches the goals of teams that need to quickly adapt, innovate, and grow. This misalignment can create several pain points that interfere with productivity. While some can be attributed to shifts in the marketplace, others are directly rooted in the software tools you are using to meet compliance.

Here are some common snafus and how to work your way out of them.

Multiple Stakeholders, Multiple Problems

From avionics to automotive to Medtech, highly-regulated industries see many different stakeholders and players, and that is a good thing. In order to reach peak public and functional safety, it’s crucial to value the input of multiple roles and skillsets. But, what happens if one or some of these folks don’t know how to use your RM software? At best it’s a shame that they can provide their two cents and at worst this begins a recipe for compliance disaster. To sidestep this conundrum, opt for software that seamlessly flows with multiple roles. More so, make sure whatever software you choose integrates user-friendly traceability. It’s crucial that each and every individual on the project be able to see the progress made from beginning to end.

So, You Missed a Deadline…

It happens to the best of us. You were asked to provide feedback on a requirement and you missed your shot to chime in. Whether a colleague left a comment for you in a Word or Google Doc or shot over an email to glean your opinion, the mode of collaboration you have in place failed you. That’s right, this isn’t all your fault. Review processes are too complex these days and they require collaboration software that sets the intentions of the users clearly. This requires real-time editing and notifications to help keep you and your team on track. To prevent falling into this trap, look for an RM tool that prompts the next steps, and sends timely notifications with clear instructions. Conversations about “who dropped the ball” aren’t productive or fair, the RM software you integrate should fill this gap in human error.

You’ve Been Blocked

You are frantically trying to enter crucial data into the system but you are somehow locked out. You can’t get a hold of the person who manages access and you are beginning to feel frantic. This isn’t just frustrating for you, it also poses some substantial risks to the company. On top of losing a couple of hours trying to break into the system, this clunky process inevitably chips away at the desire to provide feedback with any regularity or confidence. This goes against the entire purpose of collecting data in the first place. To facilitate continuous growth and data collection, your RM tool should be open, accessible, and intuitive. Only then will you encourage the kind of constant input and collaboration from stakeholders that is necessary to keep up with breakneck innovation.

When an Upgrade Spells Doom

Back in the day, we all used to get skittish when an iPhone software upgrade notification popped up on our screen. Will I lose all my photos and contacts? What about all those passwords I saved to log-in to my favorite apps? With the advent of the Cloud, much of this fear has dissipated. When it comes to your RM software, your team shouldn’t be afraid to upgrade the system to fix issues, improve security, and access the latest features.

Yet, these systems are often so customized or patched-together that an upgrade could mean disaster. Because the products you are building change and improve over time, you should have an RM system that can adapt quickly. When it’s time to purchase legacy software, weigh the opportunity costs of investing in something so stale. Ultimately, is the pain of being locked-out or unsupported on various platforms worth the headache?

Pain points aside, we are living in an age that has bred the most disruptive and creative products to date. From ultra-fast and sleek electric cars to life-like prosthetics to self-piloted spaceships, we have some of the best and brightest minds toiling away on how to propel us into the future. At the same time, the regulatory environment has become even more stringent to meet both the demands of the marketplace and public safety. It is going to take synced and streamlined teams to decrease time-to-market and meet the ever-increasing demands of compliance. To pull this off, you need collaboration infrastructure in place that keeps your team organized and catches mistakes often missed by disconnected individuals.

If you’re interested in learning more about requirements management, we’ve compiled some great resources for you here.

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

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

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

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

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

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

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

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

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

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

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

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

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

 

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

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

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

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

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

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

A product development team’s success or failure hinges on the many decisions it makes throughout a development cycle. Those choices are influenced by a myriad of factors, including balancing timing, regulations, production costs, customer feedback and benefits to the end user.

Given the complexity of products today, it takes multiple team members to weigh-in on key decisions. And the number of decision points are only growing as products get more complex, making it even tougher to adequately weigh all the options and trace their impacts.

Decisions under pressure: Making an already complex process even tougher

Those who have been through crunch time know the volatile element hanging over all decisions throughout development is pressure — whether it’s related to deadlines, complexity or the organization­. Here are some examples.

Decision Pressure = Not Enough Time

Depending on the number of stakeholders, their schedules, and level of involvement in the development process, receiving input on key changes or milestones can be an extremely tedious and time-consuming endeavor.

Getting multiple parties to sign off on a plan traditionally takes time, and it becomes nearly impossible if circumstances change while working through an especially sluggish sign-off process.

Decision Pressure = Not Enough Data

When debating decisions with team members — whether they’re executives, engineers or interns — good data strengthens the argument.

Running on instincts works for certain things, but if you’re constantly making tough calls without solid data, there’s a high probability of hitting problems— such as rework, delays and failures— later on.

Having visibility into the data used to define original requirements, as well as any new information causing requirements to change, is essential.

Decision Pressure = No Visibility Into Impact

Any new decisions must also take into account how they will impact the original requirements. One tweak to a requirement may cause ripple effects that impact the product in unintended ways.

Issues may be uncovered in the testing stage, but if one tiny change means a complete redesign, you’re going to miss market opportunities and blow past your budget.

Modern Traceability Relieves Decision Pressure

The practice of traceability was created to demonstrate that good decisions were made throughout development. While it’s a concept that has been around a while, it has had to evolve to keep up with a transforming, increasingly complex and time-sensitive product development process.

Building off the gains of the past, modern traceability is a new way of handling the process that’s built to support how people think and work.

Critically, it’s focused not just on the actions of an individual person, but entire teams over time. And this provides many benefits.

Less Pressure from Connected Data = Saved Time

Having a platform to power modern traceability is crucial. At a minimum, it needs to record, share and display data.

Crucially though, it also must be easy to use — so anyone on your team, from any experience level, can take advantage of it immediately with only a small learning curve.

Using modern traceability tools allows you to quickly show how the work being done is related to the company’s overall goals, which speeds up review cycles.

Less Pressure from Connected Data = On-Demand Context

Instead of data only being available at the end of a project or during major milestones (when people have the time), modern traceability’s data is continuously updated by the entire team and it’s always live and accessible.

For example, if all requirements have direct links to the original intent of the organization for a project, it’s easy to see whether a change is in alignment or deviating from that goal.

Simply look upstream from a requirement (or test, or design, etc.) to see why that piece of work existed. This provides valuable context ahead of any decisions to make a change. Have questions about why? Ask the person who added that upstream content directly.

Less Pressure from Connected Data = Clarity on Impacts to Requirements and People

While traceability practices have always connected test data to requirements, modern traceability delivers visibility into how people are connected to, and impacted by, changes to ongoing development work.

When a test fails, not only is it possible to see what requirements are impacted, modern traceability also offers the ability for affected parties to be notified immediately. No waiting for a major milestone review when pivots are costly. It amplifies the effectiveness of collaborative work already being done, and works best when you’ve got the right tool to utilize it.

The benefits of modern traceability are increasingly becoming essential for teams serious about creating better products with less waste and timelier cycles.

With modern traceability, you can connect data to make informed decisions faster and do your job better.

To learn more, check out our webinar, “Products Under Pressure: How to Leverage Traceability to Power Better Decisions.”

Recently I decided it was time I improved my cooking skills. Being an analytical person, I spent a considerable amount of time deciding on an approach. One must have a strategy, measurements for success, and a repeatable pattern of course! (Right?) Given that I like to run repeated experiments, I decided to take a set of dishes I wanted to master, find a few variants (similar recipes), and repeat them until I understood what specific ingredients, tools and techniques were essential.

blog-featured-image-template-cooking

The act of repeating recipes itself turned out to be the valuable lesson. Following the steps, not isolating the science behind it each decision, allowed skills to be internalized in concert. There is no single essential technique, or secret ingredient. Having a full toolbox of interrelated skills and past decisions to call upon is what works. While it’s hard to measure the exact causes for success, my larger goal is being met as my cooking improves!

Using modern traceability in product development, those that allow you to connect data and people across an organization, follows a similar pattern. Some complex situations call for traceability recipes, others just common sense. It’s a collection of related tools and behaviors used for a purpose – successful product delivery. It’s flexible, adaptable, and evolving to keep up with the demands of building high quality products fast. While I might have tried to limit or isolate traceability like it’s a single secret ingredient, I’m finding it’s more valuable to consider its many forms together as I did learning to cook.

Below are some of the goals our customers have found traceability can in fact solve. Recipes from master chefs, if you will.

Finding the Source of a Decision – Before you get to work making a change, use traceability to understand the why behind decisions.

  •  Use Modern Traceability to keep conversations connected as context, and do so continuously. This reduces the time required to find the source of past decisions, and doesn’t rely on flawed human memory to answer the question “why did we decide that again?”
  • What’s connected: Track decisions associated to requirements changes as closely to the requirement itself as possible, such as in the comments. Use tools like Jama’s Review Center to keep comments all related to the same set of data clearly saved in one spot, and referenceable later.

Adapting to Challenges and Change – When a major change does need to happen, easily see the ripple effect up and downstream at any point in a project, not just milestones.

  • Use Modern Traceability to see potentially risky changes coming. When you track and relate requirements as you work, it’s much easier to see the impacted data when a change is proposed. Teams can adapt more quickly because the map of how your product is built exists throughout the project, not just at major milestones.
  • What’s connected: Associate people to the requirements themselves. Use this to quickly see who’s related to data, tests, requirements, etc. connected 1-2 levels in either direction. Notify connected people automatically when major things change.

Managing Risk – Keep track of risks and mitigations as you work, in a shared tool so re-use of similar data is easy and visibility is high.

  • Use Modern Traceability to reduce the heavy lift of managing risk data. Update your tracking of risk dynamically, tied to requirements, and visible to the entire team working on your product. Generate a view of how you’re doing along the way, and share it long before an audit.
  • What’s connected: Configure your teams’ traceability map to include links from requirements to risks, mitigations, environmental context, and test data.

“Are we there yet?!” Status Updates – Everyone needs to know how the team is doing, at different times and at different data granularities.

  • Use Modern Traceability to shared dynamic views of progress, at the level of data that makes sense for the audience. Skip generating manual static reports, and instead share live, accurate ones.
  • What’s connected: For this to work you need a common language, and that is derived by connecting all the levels of product data so everyone has a familiar anchor point. Create relationships from the highest level market requirements, to draft designs, to requirements, to passed test in Jama. This gives every use the ability to pick a data type they are familiar with and see progress at that level, whether that means seeing the status of the requirements a marketing goal decomposes to, or looking at all the downstream test status for a particular hardware component.

Referencing Similar Past Projects – By maintaining data and relationships throughout a project, by the end that project will be full of rich insights that can be used in the future.

  • Use Modern Traceability to look at past projects as a whole, across all the data types from requirements to comments. Find projects that were successful, and use that as a starting point for new projects.
  • What’s connected: Everything! Data should be explore-able, like a map, so anyone can self-serve when they want to know answer to questions like “what did we do last time?”

The product development world is getting more complex, time pressured, and all in a changing environment of rules and regulations. To keep up, your traceability practices need to adapt, to take into account how humans and teams actually think. As your team adopts new traceability practices, though, I humbly encourage you to approach it like learning a complex skill such as cooking. It’s not any one practice, ingredient or tradition that leads to success. Think of how many moving parts there are on a successful team release! Integrating traceability skills and tools into daily work in a way that continues to value traditional Traceability (we still need reports for regulatory bodies, for example!) but also leaves room for new complex skills to emerge that mirror your specific favor of product delivery!

Read Forrester Report about the use of Modern Traceability and how it improves developers’ ideas, processes, and software.