Ready and Fit: Adopting Agile in Highly Regulated Environments

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If you live and work in a highly regulated environment (HRE)-medical devices, DoD and its contractors, nuclear energy, or other life-critical systems-this session is for you. For the past three years, …

If you live and work in a highly regulated environment (HRE)-medical devices, DoD and its contractors, nuclear energy, or other life-critical systems-this session is for you. For the past three years, the SEI has been researching agile and lean adoptions in the US Department of Defense. Suzanne Miller presents the organizational and cultural factors they identified as most important for development organizations to demonstrate when embarking on an agile adoption program. In the SEI's technology transition research, Suzanne and her team found that the more closely an organization meets the readiness and fit criteria, the more likely it is that the adoption will succeed. Suzanne discusses the risks and challenges that agile adoption presents to HREs, and presents ways to mitigate risks and overcome challenges. Find out about agile readiness assessments you can conduct before proceeding and then use as a check along the way to your organization's agile adoption.

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  • 1.           AW5 Concurrent Session  11/7/2012 2:15 PM                "Ready and Fit: Adopting Agile in Highly Regulated Environments"       Presented by: Suzanne Miller Software Engineering Institute           Brought to you by:        340 Corporate Way, Suite 300, Orange Park, FL 32073  888‐268‐8770 ∙ 904‐278‐0524 ∙ sqeinfo@sqe.com ∙ www.sqe.com
  • 2. Suzanne Miller Software Engineering Institute Suzanne (SuZ) Miller is a senior member of the technical staff at the Software Engineering Institute of Carnegie Mellon University, working in the Acquisition Support Program's Military Services team. Her current research focuses on the use of lean and agile methodologies in various DoD contexts. An authorized instructor for Intro to CMMI-SVC, SuZ is active in supporting development of training for CMMI-SVC. For the past twenty-five years she has been involved with both industry and government in the improvement of software and systems engineering. SuZ coauthored (with Richard Turner) CMMI Survival Guide: Just Enough Process Improvement.  
  • 3. Ready and Fit: Adopting Agile in Highly Regulated Environments Suzanne Miller Senior Researcher Software Engineering Institute Carnegie Mellon University SuZ Miller Agile East 2012 © 2012 Carnegie Mellon University Agenda Problems Adopting Agile in Regulated Environments y Our Journey Comparing Cultural Elements between Traditional and Agile Environments Some Ideas to Consider Applying Our Learning i Oth R A l i O L i in Other Regulated E i l t d Environments t SuZ Miller Agile East 2012 © 2012 Carnegie Mellon University 1
  • 4. Polling Question Please identify yourself as one of the following: • DoD or non-DoD Federal Program Office staff • Contractor – Federal or DoD • Commercial • Consultant for tools/process • Other SuZ Miller Agile East 2012 © 2012 Carnegie Mellon University What are some Regulated Environments Besides the DoD? Department of Energy g (both p pharmaceuticals and medical Food and Drug Administration ( devices)… Financial exchanges like the stock market… Healthcare records management… International trade… I t ti lt d …more environments than you might think are dealing with this SuZ Miller Agile East 2012 © 2012 Carnegie Mellon University 2
  • 5. Problems in Highly Regulated Environments (especially when trying Agile methods) Inherently conflicting regulations and mandates g g The “ghosts” in the regulations • We’re still “cutting off the ends of the roasts” The unwritten laws that are what the written law is really about • “The written law is there to protect <someone, maybe you?>, and persecute those who violate the unwritten law” One role’s process is another role’s outcome role s role s Problems of the past become the regulations we have to live with today SuZ Miller Agile East 2012 © 2012 Carnegie Mellon University A Particular Problem Adopting Agile Methods in Highly Regulated Industries Agile methods are based on an explicit set of principles that emphasize • Incremental learning • Trust • Multiple roles working shoulder to shoulder The principles underneath many acquisition regulations (especially in DoD) are not explicit. Principles that can easily be inferred from DoD acquisition (and similar) regulations include: • We must document everything about the system’s requirements before we start designing and implementing—not much opportunity for incremental learning • Minimize the risks to the acquisition agency – not much opportunity for trust • Keep contractors at arm’s length, maintain govt independence from them— not much opportunity for working shoulder to shoulder However, many of the regulations that lead to these inferences CAN be interpreted other ways! SuZ Miller Agile East 2012 © 2012 Carnegie Mellon University 3
  • 6. DoD Acquisition and Innovation Many regulated environments, like the DoD, NEED innovation and NEED incremental improvements to their systems. Many of them are now willing to consider changing their approach if they can do it without getting in trouble with their governing statutes and regulations. SuZ Miller Agile East 2012 © 2012 Carnegie Mellon University The View of Our Customers SuZ Miller Agile East 2012 © 2012 Carnegie Mellon University 4
  • 7. We Need to Translate between Alternate Worlds Fixed Vision Evolving Vision SuZ Miller Agile East 2012 © 2012 Carnegie Mellon University SEI ASP Agile Portfolio FY10 -14 (Our Journey) Focus Areas: making sense of the effects of the regulatory environment and finding successes that can be shared with others trying to embark on the journey Mgmt roles, estimation, culture, milestone reviews-barriers & high level recommendations (CMU/SEI-2011-TN002) Policy & regulations barriers analysis CrossTalk Article Executive Briefing 2009 2010 2011 804 response , rqmts mgmt, contracting language, other topics per Agile Collab Grp (multiple publications 2012 2013 More topics per Agile Collaboration Group priorities September 2014 2014 Metrics E-Learning Agile Course Denotes Air Force Funded NDIA C4ISR Committee Multiple Presentations Agile Defense Adoption Proponents Team (ADAPT) member Consulting on Actual DoD & Federal Programs 2011 and forward Support Mechanisms SuZ Miller Agile East 2012 © 2012 Carnegie Mellon University 5
  • 8. Making Sense of the Environment Traditional cultural analyses for adoption of Agile methods don’t tend to pick up some of the acquisition issues inherent in these environments. SEI Readiness & Fit Analysis and its underlying model explicitly include risk areas known to impede Agile adoption in regulated environments: • More emphasis on business models, goal alignment, and acquisition strategy • More focus on alignment issues—especially related to staff turnover • Some particular issues around interfacing with systems engineering in large systems developments Categories of RFA model: • • • • Business & Acquisition Project & Customer Climate System Attributes Organizational Environment -Technology Environment -Practices SuZ Miller Agile East 2012 © 2012 Carnegie Mellon University Example Factors in Business & Acquisition Category Mechanisms are in place in the contract and acquisition strategy to allow close collaboration between de e ope s and end use s developers a d e d users Oversight mechanisms are aligned with agile principles Contract type accounts for use of agile/lean methods in the program Mechanisms are in place in the contract and acquisition strategy that allow for interim demonstration and delivery between official releases SuZ Miller Agile East 2012 © 2012 Carnegie Mellon University 6
  • 9. Polling Question How Big a Challenge is Your Adoption of Agile Practices? • large, we need a culture change • medium, we are running into issues , g • small, we are mostly ready • no challenge at all SuZ Miller Agile East 2012 © 2012 Carnegie Mellon University Suggesting Successful Approaches Educating leadership and staff on differences they will see Reminding organizations of the typical challenges they face for a big change Disseminating successful approaches when we find them Adding in a little humor along the way… SuZ Miller Agile East 2012 © 2012 Carnegie Mellon University 7
  • 10. Comparison of Agile and Traditional DoD Cultural Elements1 http://www.sei.cmu.edu/library/abstracts/reports/11tn002.cfm?DCSext.abstractsource=SearchResults SuZ Miller Agile East 2012 © 2012 Carnegie Mellon University Comparison of Agile and Traditional DoD Cultural Elements2 http://www.sei.cmu.edu/library/abstracts/reports/11tn002.cfm?DCSext.abstractsource=SearchResults SuZ Miller Agile East 2012 © 2012 Carnegie Mellon University 8
  • 11. Comparison of Agile and Traditional DoD Cultural Elements3 http://www.sei.cmu.edu/library/abstracts/reports/11tn002.cfm?DCSext.abstractsource=SearchResults SuZ Miller Agile East 2012 © 2012 Carnegie Mellon University Translating DoD Lessons into Other Highly Regulated Environments If the things I have talked about resonate with you • Read some of our papers/presentations to get ideas – The time you spend translating from DoD to your environment is likely to pay off with some new ideas to try that might well work! • See where strategies that have worked in DoD might apply to you – Look for places in our work where you have faced similar situations – If you have a success strategy you don’t see us promulgating, please consider sharing with us! We’re here to learn! SuZ Miller Agile East 2012 © 2012 Carnegie Mellon University 9
  • 12. A Few Things to Think About When People Cite “Regulations” as a Reason *Not* to Embrace Agile Approaches Who are the real stakeholders? Where are the political “bodies” buried? How do the “ghosts” in the stakeholder map affect what people do today? y Value stream mapping, a lean technique, is sometimes useful to point out waste areas where Agile could help, in an organizationthat is trying to reduce cost by eliminating wasted effort When analyzing processes currently in use, always ask “For whom?” and “So what? (ask about your Agile practices too!!) So what?” Most regulated environments involve conflicting mandates: different people choose different areas to emphasize—try to find the ones most complementary to Agile approaches and focus on those SuZ Miller Agile East 2012 © 2012 Carnegie Mellon University Agile Work – Published and in Process Published Considerations for Using Agile in DoD Acquisition • http://www.sei.cmu.edu/library/abstracts/reports/10tn002.cfm?DCSext.abstractsource=SearchResults Agile Methods: Selected DoD Management and Acquisition Concerns • http://www.sei.cmu.edu/library/abstracts/reports/11tn002.cfm?DCSext.abstractsource=SearchResults A Closer Look at 804: A Summary of Considerations for DoD Program Managers • http://www.sei.cmu.edu/library/abstracts/reports/11sr015.cfm?DCSext.abstractsource=SearchResults DoD Agile Adoption: Necessary Considerations, Concerns, and Changes http://www.crosstalkonline.org/issues/janfeb-2012.html • In Process Topics • • • • • • Information Assurance Requirements Contracting language and contract types Contingency Model (Readiness and Fit to use agile) Programmatics Guide to Agile terminology from a traditional viewpoint SuZ Miller Agile East 2012 © 2012 Carnegie Mellon University 10
  • 13. Contact SuZ Miller at: smg@sei.cmu.edu 412-268-9143 SuZ Miller Agile East 2012 © 2012 Carnegie Mellon University Copyright 2012 Carnegie Mellon University. This material is based upon work supported by the Department of Defense under Contract No. FA8721-05-C-0003 with Carnegie Mellon University for the operation of the Software Engineering Institute, a federally funded research and development center. Any opinions, findings and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the United States Department of Defense. NO WARRANTY THIS CARNEGIE MELLON UNIVERSITY AND SOFTWARE ENGINEERING INSTITUTE MATERIAL IS FURNISHED ON AN “ASIS” BASIS. CARNEGIE MELLON UNIVERSITY MAKES NO WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED, AS TO ANY MATTER INCLUDING, BUT NOT LIMITED TO, WARRANTY OF FITNESS FOR PURPOSE OR MERCHANTABILITY, EXCLUSIVITY, OR RESULTS OBTAINED FROM USE OF THE MATERIAL. CARNEGIE MELLON UNIVERSITY DOES NOT MAKE ANY WARRANTY OF ANY KIND WITH RESPECT TO FREEDOM FROM PATENT, TRADEMARK, OR COPYRIGHT INFRINGEMENT. This material has been approved for public release and unlimited distribution except as restricted below. Internal use:* Permission to reproduce this material and to prepare derivative works from this material for internal use is granted, provided the copyright and “No Warranty” statements are included with all reproductions and derivative works. External use:* This material may be reproduced in its entirety, without modification, and freely distributed in written or electronic form without requesting formal permission. Permission is required for any other external and/or commercial use. Requests for permission should be directed to the Software Engineering Institute at permission@sei.cmu.edu. *These restrictions do not apply to U.S. government entities. SuZ Miller Agile East 2012 © 2012 Carnegie Mellon University 11