Compliance, Regulations And Traceability: How Lean, Agile And SAFe Principles Fit


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Agile companies do things faster.

However, when organizations begin to adopt agile processes into building some of the world’s largest and most important systems – medical devices, automobiles, avionics, banking and financial systems and aerospace and defense – terms like “faster, better, cheaper” no longer become the key motivator where failure is not an option.

To protect the public safety, these systems are often subject to extensive regulatory or customer oversight and rigorous compliance requirements. In addition, many enterprises are subject to other government regulations (Sarbanes-Oxley, HIPAA, etc.) that require similar attention and audits to ensure compliance.

Join the Continuous Engineering Experts’ Bryan Smith as he welcomes the Co-Founder and Chief Methodologist of the Scaled Agile Framework (SAFe), Dean Leffingwell to the show as they discuss how you can apply Lean-Agile and SAFe methods to build these systems faster and better, while also addressing critical compliance requirements.

0:01:13 – Let’s start out on a serious note…what does the “e” in SAFe stand for? 🙂
0:03:41 – Here’s a joke for you Dean! What do SAFe practitioners and urologists have in common?
0:05:20 – As the Co-Founder of the Scaled Agile Framework, can you explain why you brought systems engineering content specifically into the Framework?
0:14:14 – Do you see one “systems” industry outpacing others in terms of adoption of lean and agile principles?
0:21:24 – The latest SAFe release added a lot of emphasis around quality — Compliance & Lean Quality Management Systems (QMS) – how does this specifically apply to the medical device industry? Things like the FDA part 830 or an SRS, for example?
0:26:40 – How are Verification & Validation processes built into the Framework?
0:28:44 – I’ve been reading through some of the case studies listing out the benefits of adopting Scaled Agile — 30-75% faster-time-to market, for example – can systems organizations – like medical devices – expect the same sort of results?
0:32:49 – In the systems engineering space – is getting started with SAFe any different than say getting started in a traditional IT shop?
0:34:50 – How critical is leadership or management buy-in in the adoption of “lean thinking” and Scaling Agile principles?
0:38:32 – Any closing thoughts for us Dean? What’s next for Lean, Agile and SAFe methodologies?

Want to learn more?
Register for “Leading SAFe 4.5” and learn how to execute and release value through Agile Release Trains, how to build an Agile Portfolio, and how to lead a Lean-Agile enterprise. Targeted towards the lean-agile leaders in your organization, attendees typically include executives, managers, consultants, Lean-Agile Leaders, and other Agile change agents.

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