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7 replies Latest Post - ‏2012-04-16T10:52:53Z by KeithCollyer
Holitza
Holitza
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Pinned topic Can Agile work for highly regulated environments?

‏2012-01-20T22:20:24Z |
Can Agile work for highly regulated environments?
Updated on 2012-04-16T10:52:53Z at 2012-04-16T10:52:53Z by KeithCollyer
  • ScottAmbler
    ScottAmbler
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    Re: Can Agile work for highly regulated environments?

    ‏2012-01-26T20:27:22Z  in response to Holitza
     Absolutely.   I've worked with agile teams which must conform to various regulatory guidance, including but not limited to FDA regulations and Sarbox. 
     
    I've written a fair bit about about agile and regulatory compliance for anyone interested. Depending on the regulations you're going to have to do a little more documentation, likely hold a few more reviews, and gather evidence about how you worked and what you actually did.  Each regulation varies so I highly suggest reading them yourself if they do apply to your team.  If you let bureaucrats interpret the regulations for you then you shouldn't complain if they propose a bureaucratic solution.
     
    The November 2009 Agility at Scale survey also asked about this specifically and many respondents indicated successfully doing agile in a regulatory environment.
    • ScottWill
      ScottWill
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      Re: Can Agile work for highly regulated environments?

      ‏2012-02-17T03:11:45Z  in response to ScottAmbler
      In addition to Scott's comments, the other thing I've seen in working with customers in highly-regulated environments is that often there's a misunderstanding of what's really needed.  Because of the possibility of failing regulatory compliance audits (as one example), organizations tend to be over-cautious and wind up doing WAY more than necessary.  If you consider the regulatory agency as one of your stakeholders, then Agile would prompt you to work with them to understand exactly what's needed -- deliver that and no more.  Remember that one of the Agile principles is, "Simplicity -- the art of maximizing the amount of work not done -- is essential."  (http://agilemanifesto.org/principles.html)
  • KirkWoods
    KirkWoods
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    Re: Can Agile work for highly regulated environments?

    ‏2012-03-31T06:15:16Z  in response to Holitza
     It depends on the regulations/standards you are required to follow.  For example, ISO9001 requires that you do what you say you do and have the evidence to back it up.  This makes being ISO9001 certification very easy to do with agile especially if you use RTC to define and track your usage of agile processes.  The FDA regulations for software deal with medical devices after they are created and says virtually nothing about how the software is developed, so it is easy to fit agile into the regulations of the FDA.
    On the other hand, MIL-STD-498 and its successor IEEE/ISO/IEC 12207 would be rather difficult to use Agile, because by definition they are waterfall. It would be possible to use Agile techniques during the development phase like breaking the development activities into multiple sprints, tracking progress using Scrum, and using test driven development; but there is a significant amount of documentation that is shelf-ware to be able to call it agile.
    • KeithCollyer
      KeithCollyer
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      Re: Can Agile work for highly regulated environments?

      ‏2012-04-03T14:09:13Z  in response to KirkWoods
       My understanding of 12207, though not direct, is that it is V-model, but not (necessarily) waterfall. That is, it defines dependencies between artifacts, but these are logical not purely chronological. So if B depends on A, you cannot complete B before completing A, but you do not have to complete A before starting A.
      • KirkWoods
        KirkWoods
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        Re: Can Agile work for highly regulated environments?

        ‏2012-04-03T22:10:47Z  in response to KeithCollyer
        Yes 12207 is V-model.  Of the multiple companies I have worked for that followed "waterfall", only one followed a strict waterfall model whereas most were more V-model like.   With regard to the original question about Agile working in "highly regulated environments", there is not a lot of difference between waterfall and V-model in my opinion.  There are agile practices that one can use, but I would not call the process one has to follow agile.
      • M_Kevin_McHugh
        M_Kevin_McHugh
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        Re: Can Agile work for highly regulated environments?

        ‏2012-04-13T04:45:38Z  in response to KeithCollyer
        I refer to the V model frequently.  However, I make it clear that I am really after the data relationships rather than implying a need for chronological behavior.  I use mini-V's inside stories for illustrative purposes.  It's not strictly true chronologically since the story moves from the backlog into the sprint.  But, the story still ends up with many of the data/artifact behaviors as it moves along.   Sort of like a car with a single team building it rather than having pieces bolted on at each station by a person performing a single task.
        • KeithCollyer
          KeithCollyer
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          Re: Can Agile work for highly regulated environments?

          ‏2012-04-16T10:52:53Z  in response to M_Kevin_McHugh
           Exactly! It's the data relationships that are most important. In principle, you could create all the system requirements first and still have a V-model - though I wouldn't recommend that approach. I love the analogy of the car, it also highlights that mass-production manufacturing is highly applicable to, well, mass production, but what we are building is generally a custom job.