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, 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.

Text of Ready and Fit: Adopting Agile in Highly Regulated Environments

  • 1. AW5 ConcurrentSession 11/7/20122:15PM "Ready and Fit: Adopting Agile in Highly Regulated Environments" Presented by: Suzanne Miller Software Engineering Institute Broughttoyouby: 340CorporateWay,Suite300,OrangePark,FL32073 88826887709042780524sqeinfo@sqe.comwww.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 UniversitySuZ Miller Agile East 2012 2012 Carnegie Mellon UniversityAgenda 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 tSuZ Miller Agile East 2012 2012 Carnegie Mellon University1 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 OtherSuZ Miller Agile East 2012 2012 Carnegie Mellon UniversityWhat 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 dmore environments than you might think are dealing with this SuZ Miller Agile East 2012 2012 Carnegie Mellon University2 5. Problems in Highly Regulated Environments (especially when trying Agile methods) Inherently conflicting regulations and mandates g g The ghosts in the regulations Were still cutting off the ends of the roastsThe unwritten laws that are what the written law is really about The written law is there to protect , and persecute those who violate the unwritten lawOne roles process is another roles outcome role s role s Problems of the past become the regulations we have to live with todaySuZ Miller Agile East 2012 2012 Carnegie Mellon UniversityA 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 shoulderThe 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 systems requirements before we start designing and implementingnot much opportunity for incremental learning Minimize the risks to the acquisition agency not much opportunity for trust Keep contractors at arms 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 University3 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 UniversityThe View of Our CustomersSuZ Miller Agile East 2012 2012 Carnegie Mellon University4 7. We Need to Translate between Alternate Worlds Fixed VisionEvolving VisionSuZ Miller Agile East 2012 2012 Carnegie Mellon UniversitySEI 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 journeyMgmt roles, estimation, culture, milestone reviews-barriers & high level recommendations (CMU/SEI-2011-TN002)Policy & regulations barriers analysisCrossTalk ArticleExecutive Briefing200920102011804 response , rqmts mgmt, contracting language, other topics per Agile Collab Grp (multiple publications20122013More topics per Agile Collaboration Group priorities September 20142014Metrics E-Learning Agile CourseDenotes Air Force FundedNDIA C4ISR Committee Multiple PresentationsAgile Defense Adoption Proponents Team (ADAPT) memberConsulting on Actual DoD & Federal Programs 2011 and forwardSupport MechanismsSuZ Miller Agile East 2012 2012 Carnegie Mellon University5 8. Making Sense of the Environment Traditional cultural analyses for adoption of Agile methods dont 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 issuesespecially 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 -PracticesSuZ Miller Agile East 2012 2012 Carnegie Mellon UniversityExample 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 University6 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 allSuZ Miller Agile East 2012 2012 Carnegie Mellon UniversitySuggesting 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 waySuZ Miller Agile East 2012 2012 Carnegie Mellon University7 10. Comparison of Agile and Traditional DoD Cultural Elements1http://www.sei.cmu.edu/library/abstracts/reports/11tn002.cfm?DCSext.abstractsource=SearchResults SuZ Miller Agile East 2012 2012 Carnegie Mellon UniversityComparison of Agile and Traditional DoD Cultural Elements2http://www.sei.cmu.edu/library/abstracts/reports/11tn002.cfm?DCSext.abstractsource=SearchResults SuZ Miller Agile East 2012 2012 Carnegie Mellon University8 11. Comparison of Agile and Traditional DoD Cultural Elements3http://www.sei.cmu.edu/library/abstracts/reports/11tn002.cfm?DCSext.abstractsource=SearchResults SuZ Miller Agile East 2012 2012 Carnegie Mellon UniversityTranslating 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 dont see us promulgating, please consider sharing with us! Were here to learn!SuZ Miller Agile East 2012 2012 Carnegie Mellon University9 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 emphasizetry to find the ones most complementary to Agile approaches and focus on those SuZ Miller Agile East 2012 2012 Carnegie Mellon UniversityAgile Work Published and in Process Published Considerations for Using Agile in DoD Acquisitionhttp://www.sei.cmu.edu/library/abstracts/reports/10tn002.cfm?DCSext.abstractsource=SearchResultsAgile Methods: Selected DoD Management and Acquisition Concernshttp://www.sei.cmu.edu/library/abstracts/reports/11tn002.cfm?DCSext.abstractsource=SearchResultsA Closer Look at 804: A Summary of Considerations for DoD Program Managershttp://www.sei.cmu.edu/library/abstracts/reports/11sr015.cfm?DCSext.abstractsource=SearchResultsDoD Agile Adoption: Necessary Considerations, Concerns, and Changes http://www.crosstalkonline.org/issues/janfeb-2012.htmlIn 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 viewpointSuZ Miller Agile East 2012 2012 Carnegie Mellon Univer