More Related Content Similar to Agility and Compliance (Andrea Tomasini, agile42) (20) Agility and Compliance (Andrea Tomasini, agile42)1. Agility and Compliance
The What and the How problem...
agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
2. Andrea Tomasini
Agile Coach & Trainer
andrea.tomasini@agile42.com
agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
3. Andy Carmichael
Andrea's 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.
4. Why Agility?
agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
5. 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
Complexity
agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
6. 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
Complexity
agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
7. .5 years
13
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 significantly
agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
8. Why does this matter?
Defined Process Control vs. Empirical Process Control
agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
9. 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.
10. 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.
11. Why Compliance?
agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
12. compliance (also compliancy
)
noun
1 the action or fact of complying with a wish or
command : they must secure each other's cooperation or
compliance.
• ( compliance with) the state or fact of according
with or meeting rules or standards : all imports of timber
are in compliance with regulations.
agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
13. What are the reason to require Compliance?
Compliance is about guaranteeing
that a product reaching the market
will satisfy the rules that regulate that
market...
Compliance is about adhering to a
set of rules considered vital to
preserve human life safe
agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
14. 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 software
agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
15. Recipe for IEC/EN 62304
Based on 60601-1-4 and AAMI 68
Aligned with FDA terminology
and expectations
Allows the manufacturer to
chose the best process,
techniques and tools
Defines
minimal levels
for process
Activities
agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
16. 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 Resolution
agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
17. The WHAT & HOW problem...
agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
18. €
Comparing the Goals
1 Patient Safety
2 Effectiveness
3 Governance throughout
product lifecycle
4
5
6
Productivity
d !
e
Mainly
v
Predictability/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.
19. 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.
20. €
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.
21. €
Standard Operating Procedures vs.
Continuous Process Improvement
The 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/Scrum
agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
22. €
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/Scrum
agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
23. What do we VALUE more?
agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
24. ...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.
25. so what?
agile42 | We advise, train and coach companies building software www.agile42.com | All rights reserved. Copyright © 2007 - 2009.
26. 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.
27. 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.