Agility and Compliance (Andrea Tomasini, agile42)
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Agility and Compliance (Andrea Tomasini, agile42)

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Implementing agility in a strongly Regulated environment is sometimes a challenge. Many teams and company do find ways, but most of these are against the agile principles or are turning out to be big ...

Implementing agility in a strongly Regulated environment is sometimes a challenge. Many teams and company do find ways, but most of these are against the agile principles or are turning out to be big impediments. Mostly the problem being that from compliance authorities we get told HOW to do things and not WHAT they will measure to prove quality and compliance. Can we do better? Sure we can, transparency is the key...

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    Agility and Compliance (Andrea Tomasini, agile42) Agility and Compliance (Andrea Tomasini, agile42) Presentation Transcript

    • Agility and ComplianceThe What and the How problem...agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
    • Andrea TomasiniAgile Coach & Trainerandrea.tomasini@agile42.comagile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
    • Andy Carmichael Andreas company is called agile42 and if you think about it the name has some logic to it - "agile" is the undisputed answer to all the major questions of software engineering (mmm...?) in the same way that 42 is the answer to that only slightly larger chestnut: life, the universe and everything...agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
    • Why Agility?agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
    • Software lines in FORD vehicles over the past 5 years 10 10 7.5 6 x4 5 4.5 3.4 2.8 2.4 2.5 0 2005 2006 2007 2008 2009 2010 Software complexity in FORD vehicles Growing Software quadruplicated in 5 years Complexityagile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
    • F-22 Raptor 1.7 F-35 Joint Strike 5.7 x1 0 Boeing 787 Dreamliner 6.5 S-Class Daimler 98.6 Compared software complexity growth in Growing Software aerospace and automotive Complexityagile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
    • .5 years13 3 m on th s 1915 1939 1972 1976 1983 1994 1998 2000 2002 2004 Deepa Chandrasekaran, Gerard J. Tellis - Marshall School of Business, University of Southern California, Los Angeles, California Due to globalization effects, and other economical changes, the time to market over Time to Market time decreased significantlyagile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
    • Why does this matter?Defined Process Control vs. Empirical Process Controlagile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
    • Defined Process, suited to produce faster Change from this...agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
    • Empirical Process, suited for R&D ... to this.agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
    • Why Compliance?agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
    • compliance (also compliancy )noun1 the action or fact of complying with a wish orcommand : they must secure each others cooperation orcompliance.• ( compliance with) the state or fact of accordingwith or meeting rules or standards : all imports of timberare in compliance with regulations.agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
    • What are the reason to require Compliance?Compliance is about guaranteeingthat a product reaching the marketwill satisfy the rules that regulate thatmarket...Compliance is about adhering to aset of rules considered vital topreserve human life safeagile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
    • Don’t get lost in the jungle... ISO EN Risk 1497 62 1 3 Man Us 66:2 agem abi ent lity 007 ISO 3 EN :200 13 485 ity Q ual ent gem M ana 1-1-4 I SO 6060 ectrical ISO m able el Med 6230 P rogram ic es Soft ical D 4 med ical dev war e Li evic e fecy cle ISO 62304 closely guides / determines development of medical softwareagile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
    • Recipe for IEC/EN 62304Based on 60601-1-4 and AAMI 68Aligned with FDA terminologyand expectationsAllows the manufacturer tochose the best process,techniques and toolsDefinesminimal levelsfor processActivitiesagile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
    • Overview of IEC/EN 62304 7 Software Risk Management 6.1Establish 6.2 Problems SW and Maintenance Modification Plan analysis 6.3 Software Modification Implementation 5.3 Software 5.4 Software 5.5 Software 5.6 Software 5.7 Software 5.8 Software Architectural Detailed Unit impl. & Integration & System Release Design Design verification int. testing Testing 8 Software Configuration Management 9 Software Problem Resolutionagile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
    • The WHAT & HOW problem...agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
    • € Comparing the Goals 1 Patient Safety 2 Effectiveness 3 Governance throughout product lifecycle 4 5 6 Productivity d ! e Mainly vPredictability/Sustainability Measure the effects o Business Value of the Product Quality p r usage Agile/Scrum A p DIN 62304 agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
    • Compliance is Model independent... This standard does NOT prescribe a specific life-cycle model. The users of this standard are responsible for selecting a life-cycle model for the software project and for mapping the PROCESSES, ACTIVITIES, and TASKS in this ? standard onto that model g s in Or not? f u on C This standard provides a framework of life-cycle PROCESSES with ACTIVITIES and TASKS necessary for the safe design and maintenance of MEDICAL DEVICE SOFTWARE. This standard provides requirements for each life-cycle PROCESS. Each life-cycle PROCESS is further divided into a set of ACTIVITIES, with each ACTIVITY further divided into a set of TASKS.agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
    • € Working Software over Comprehensive Documentation Epics Requirements Specifications User Stories Define/ Execute i t ! Verify/ Approve Dialog/Agreement Test do Design Test Design n Code Validate/ a c Update Test Execution Design We Code Documentation is minimized Requirements specifications and evolves in process drive the implementation Agile/Scrum DIN 62304 agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
    • €Standard Operating Procedures vs. Continuous Process ImprovementThe purpose of standards is A standard defines ! 1.to make it possible to any goals for a team to one to do the job i t reach, and constraints 2.to reduce variations do to observe. n 3.Standards are written by An Agile Team will use process groups / QM c a that as a Baseline for e 4.Written standards are to continuous process W be followed, not changed improvement DIN 62304 Agile/Scrumagile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
    • €Document Driven vs. Consensus Driven “This document is now ! part of a consistent “This document is now approved as input for i t product increment” the next development do n phase” “The Definition of Done c a and Definition of Ready, allow to set We minimal requirements to measure fitness to the next phase” DIN 62304 Agile/Scrumagile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
    • What do we VALUE more?agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
    • ...You have to update the 5.1, ...yes and I 5.2, 5.3 and 5.4 have to complete section of the the feature, write SOP... unit-tests, check the Acceptance Criteria and review the code...While we agree there is value on the item(s) on the left, we value the items on the right more agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
    • so what?agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
    • Conclusions• Agile is mainstream, enterprises need to adopt it, is growing• We can implement agile in a Compliance Regulated environment, but won’t come for free• The Goal of Compliance is to guarantee that we can product better Software that won’t harm humans• Continue to challenge the status quo, push for having a WHAT to achieve and leave the HOW to achieve it to yourself!agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
    • Questions? & Answers!For any further comment and or question, feel free to contact us info@agile42.com Further References: Scrum Alliance: http://www.scrumalliance.org Control Chaos: http://www.controlchaos.com Implementing Scrum: http://www.implementingscrum.com Jeff Sutherland Blog: http://jeffsutherland.com/scrum Mike Cohn “User Stories”: http://www.mountaingoatsoftware.com agile42 Website: http://www.agile42.com/agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.