Agility and Compliance (Andrea Tomasini, agile42)

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.

Andrea Tomasini
Agile Coach & Trainer
andrea.tomasini@agile42.com


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...


Why Agility?


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

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

.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


Why does this matter?
Deﬁned Process Control vs. Empirical Process Control


Deﬁned Process, suited to produce faster

Change from this...

Empirical Process, suited for R&D

... to this.

Why Compliance?


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.


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


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


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


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


The WHAT & HOW problem...


€

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

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.


€
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

€
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

€
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

What do we VALUE more?


...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

so what?


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!


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/


Agility and Compliance (Andrea Tomasini, agile42)

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