Adopting Agile & Maintaining Process Control in Safety-Critical Device Development
A lot of companies working in industries that are highly regulated by standards and guidelines (safety-critical industries, such as the medical, automotive and aviation sectors) still rely on the Waterfall/V-model development method when creating software for their end products. While this doesn’t allow them to take advantage of more modern Agile methods, they choose to stick with these tried and tested methods because they help these companies ensure that certain processes are always enforced, which is key to achieving compliance with relevant standards. Process control is simply easier to do in a Waterfall environment.
However, adhering to the regulations of industry standards can also be ensured in Agile development. Adequate process control measures can be implemented just the same, which is best demonstrated by FDA’s endorsement of Agile practices. If it can be used in medical software development, where rigorous standards apply to various processes, Agile is surely compatible with development in other regulated industries.
Switching to Agile while maintaining process control
Indeed, that’s the conclusion more and more companies in various industry sectors are coming to. Agile helps teams cut risks by working on smaller chunks of the software at a time, reduce the time of development, and improve the quality of their software products. However, aligning Agile techniques with the requirements of relevant industry standards and regulations takes a bit of effort.
Therefore, if you’re looking to adopt Agile while maintaining the same control over your processes that you had using Waterfall, you will first need to map Agile practices and the stipulations of standards that apply to your industry or product. Any inconsistencies between these two will have to be addressed at an early stage of planning your Agile implementation. The end product of this analysis is hugely important: it’s going to be the set of (compliant) processes that you’ll need to enforce throughout the development lifecycle. Any deviation from these will likely result in non-compliance, and could increase the risk levels of your end product. This is a task that’s difficult enough, but there’s more to compliance than this.
Traceability down to source code will have to be ensured and proven along the lifecycle. The processes that you have set in stone in the first step should help achieve this – but proving it means that all the links between all work items will need to be recorded, documented, and shown during audits. This is where you’ll realize that adequate Application Lifecycle Management tools such as codeBeamer ALM are simply necessary when it comes to implementing Agile in safety-critical development.
Design, verification, documentation & development with ALM
The reason is simple: not only does using such solutions help enforce set processes through pre-configured workflows for each item, they can also automatically record all changes, and generate documentation to help compliance audits. Agile favours “working software over comprehensive documentation”, which is why it’s so much faster than Waterfall – but regulators in safety-critical sectors still require thorough, complete documentation, whatever development process you decide to use.
ALM tools like codeBeamer take the burden of documentation off the shoulders of your team by automatically recording a comprehensive change history on all artifacts, and letting you customize reports that can be simply exported, taking care of documentation without requiring manual effort from your team. What’s more, codeBeamer’s cutting-edge workflow engine also allows you to connect various processes (with preconfigured workflows provided via our templates for the medical, automotive and avionics industries). Thus, it enables you to maintain control over all processes throughout the entire development lifecycle.
Once you understand the basics, unlocking the benefits of Agile for safety-critical applications really isn’t that tricky. Granted, it requires a bit of initial investment in terms of purchasing and configuring an adequate ALM solution. After you start using it, however, that investment is returned in more than one ways: total control over all processes, reduced time to market, increased efficiency & product quality, and comprehensive documentation created automatically. All that simply translates into one fundamental goal: increased profitability. It’s no wonder that more and more safety-critical development companies are making the transition to Agile with the help of ALM solutions.
Interested in finding out how codeBeamer ALM can help you adopt Agile & align your processes with regulations? Drop us a line and ask for a 1-on-1 demonstration so that we can show you how our clients (global enterprises in safety-critical development) are using codeBeamer every day!