Agile in a Regulated Environment

Now, I don't know what happened when the Initiation phase was done a year ago this month, but I know what I've been doing since October on this project for a healthcare hardware maker.

It's been a while since I was exposed to FDA and HealthCanada and European Common Market regulation- and even then, it was a glancing blow- for medical gases- pretty straight forward.

With testing equipment, the load's a lot different.

The Agile Principal:

"The most efficient and effective method of
conveying information to and within a development
team is face-to-face conversation."

Is pretty much thrown out the window. Like Waterfall, paper seems to be king.

So we adapted. We put all the User Stories, comments, hazard analysis and developer notes on database changeson our wiki. A junior team member goes up to the wiki, picks a User Story, then uses  a <ctrl><a> and <ctrl><c> to save it in the clipboard then<,ctrl><v> to push it to a  Word template, clean it up and then go back for all those nice pictures the devs and managers like (because they never read the tests- sorry- Acceptance Criteria; actually, we have one dev who really reads the stories- shocked the bejesus out of me). Curse me for making Work Flow Diagrams!

Then, we add the title to a spreadsheet template with 6 to 12 bazillion acceptance signatures. Seriously. Signatures. And we get 'em, too! Then save 'em, batch print them to annoy non-project staff.

Add a test case result sheet from the QA guys (who are the only others who actually read the stories- sorry, this a class project; there's someone else who actually reads the stories, we have an actual tech writer stealing hours from my time card), a paper clip and then it gets scanned into some other application that actually freezes the User Story's state and requires an Act of Congress for a change.

This also scares me. I don't spell that well, my grammar's off sometimes when I forget 7th grade sentence parceing and I forget stuff when I'm getting whipsawed while writing a story-editing the one from last month the to which the QA team got (how's that fer grammar, eh?)-seeing my product owner making the mistake of walking by so I can grab him for just a few questions- redoing what the QA wanted me to do because he called me on a quick change instead a comlete job- and a dev asking me questions about a story written a month ago.

So, you're likely to see a few numbering, um, issues and a single word from a previous requirement I forgot to delete. My editor, who happens to be the Risk Analyst and the fellow that wrote the original version of this software, just caught two more of my , er, issues.

So the big changes the team had to make are:

• Realize we have throwback to the Waterfall/Iterative demand that 'Documentation is King.'  We created a process that isn't too heinous, but keeps the stories short, to the point and on the wiki as the primary story keeper while meeting our customer's documentation requirements.
• Sign-offs are not a simple head nod in this environment. In fact, sign-offs are worse than Waterfall.
• When you do the sign-offs after implementation (and after the head nod), it becomes a paperwork process you can hand off to a junior level team member so it doesn't get in the way.
• HIPPA, Good Manufacturing Practice. The Regulatory Guy (Gal) is the king after you meet the business needs.
• Scot needs a remedial English Course. You don't gotta know how to spell in radio.