- Two Agile Release Trains succeeded and the third did not follow, because what made them work had never been written down in a form the rest of the organization could adopt.
- The existing QMS could not cope with endeavor-specific configuration, respond to its users, or keep up with the framework's own development — so it could not prove compliance either.
- Design controls were established in an agile manner rather than bolted on, and products were subsequently certified and validated.
The challenge
Strict market regulation — FDA, IEC 62304 and a good deal more — and very high standards for product, process and tool verification and validation are the conditions this organization works under. It had moved to agile a decade earlier and launched two Agile Release Trains under SAFe® 4.0 successfully. Replicating that at a larger scale, and proving compliance to regulated requirements clearly, was where it stopped.
As at other organizations in this position, a great deal of discussion went back and forth about what the concrete implementation of SAFe® actually was. The QMS in use could not cope with endeavor-specific configurations, was not responsive to the people using it, could not absorb the framework's own further development, and in the end could not prove compliance in that environment.
- Two successful ARTs, and a third that would not follow
- A QMS that could not cope with endeavor-specific configuration
- Not responsive to its users, and unable to absorb framework updates
- Compliance to FDA and IEC 62304 that could not be proven clearly
- Applied SAFe® as Lean QMS, piloted and LACE-led
- Tailoring per endeavor — software, firmware and hardware differ
- Existing SOPs integrated; ~90% of the framework used as it comes
- Design controls established in agile, inside the process
- 30%+
- less process complexity
- ≈ 0
- field error rate
- 6 wks
- to a compliant pilot
- Certified
- products certified in the USA
What was done
A pilot was started with Applied SAFe® as the Lean QMS, with the internal LACE team trained to lead the customization. As with the other engagements, the concept was to adjust as little as absolutely necessary — a reuse rate of almost 90% — with roles used as they come and extended with specialized responsibilities rather than replaced by new ones.
Existing standard operating procedures were integrated into Applied SAFe®, and with its organizational process assets the agility and compliance of an activity could be established as self-proving evidence. Tailoring was used in its basic form first; more was built in later so that hardware and firmware endeavors could differ from pure software ones. That is where design controls were established in an agile manner.
When we discovered Applied SAFe® we were relieved! This solution makes it possible for us to adopt SAFe® to deal with the complexity within our organization, even though it's regulated and has compliance challenges. This platform helps our organization reduce waste and do what is really needed, which allows us to have lean processes so we can bring our product to market.
What changed
Process complexity came down by around a third. The departments collaborate much more closely, and the error rate in the field was permanently reduced to “almost zero”. Successful certification of products in the USA proved the chosen scaled agile way of working correct for a medical device organization — which is the argument this case had to win.
Applied SAFe® was rolled out to the Agile Release Trains soon afterwards and later as an enterprise-wide solution. While the SAFe® transition is still ongoing, assessments show the general knowledge base on SAFe® practices improved considerably, and teams that had been out of scope were gradually brought into the transformation rather than left outside it.
- Process complexity reduced by over 30%.
- Design controls identified and defined.
- Successful certification and validation of products.
- Tool validation to regulatory needs.
- Compliance established in scaled agile processes.
- Reuse rate of 90% in the Lean QMS achieved.
- Ready for a compliant pilot within six weeks.
- The organization executes lean-agile process engineering by itself after five days of training and two months of support.