Regulatory and Industry Standards Compliance with SAFe
Many systems in aerospace, defense, automotive, medical, banking, and other industries have an unacceptable social or economic cost of failure. In order to protect the public, these systems are also subject to extensive regulatory oversight and rigorous compliance standards. Historically, organizations building these systems have relied on comprehensive quality management systems and phase-gate based waterfall life cycle models to reduce risk and ensure compliance. These same organizations are now adopting Lean-Agile methods, and are struggling to understand how their existing phase-gate compliance activities participate in a Lean-Agile flow of value.
Recently I’ve had the opportunity to collaborate with Harry Koehnemann with 321Gang, one of our SPCT-Gold Partners on an update to our guidance on how to use SAFe for implementing Lean-Agile practices at scale in these high assurance contexts. Harry has helped guide organizations in aerospace, automotive, medical device, and electronics industries through Agile. Prior to coming to Scaled Agile, I (Steve) worked for many years with a variety of Federal agencies, including a program in the Department of Homeland Security that was the first full implementation of SAFe. Each of us have seen the difficulties leaders of these organizations have faced trying to “go SAFe” but still meet the rigors of their regulatory and compliance processes, which frequently assume a waterfall product development model.
As more and more organizations in these high assurance industries are pursuing a SAFe implementation, we felt it was time to revisit our recommendations and provide some practical suggestions for how overcome this challenge by using Lean-Agile practices to actually produce BETTER compliance and safety outcomes. Our recommendations focus on four key approaches:
- Taking an incremental approach to creating and assessing compliance information
- Including compliance teams and their concerns in the product development ecosystem to collaborate on planning, executing, assessing, and adapting
- Incorporate compliance in agile quality practices – automating, adapting, continuously improving, etc.
- Integrating V&V and compliance activities into iterative development flow
We recently had the opportunity to share this information in an hour-long webinar. That recording along with a PDF of our slides can be found on our updated Guidance Article on this topic. We will also be coming out soon with a white paper and other enablement materials as part of a toolkit that SPCs can use to help organizations in these industries adopt the patterns that we have seen work successfully with similar SAFe implementations
If you are planning to attend any of the following conferences you can also stop by our sessions on this topic at these events:
- Agile in Government Summit, Washington DC, April 19-20
- INCOSE Agile in Healthcare Conference, Chicago IL, May 16-17
- Agile 2017, Orlando FL, August 7-11
- SAFe Summit, San Antonio TX, October 2-6
Steve Mayner and Harry Koehnemann