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www.almacgroup.com
Adopting Agile Scrum in
a Regulated Industry
February 16, 2016
2
Topics
Almac Group
Adopting Scrum in a Regulated Industry
Managing Delivery Risk
Question and Answer
February 16, 2016
3
Biomarker
Discovery &Development
API Services
& ChemicalDevelopment
Clinical
Trial Supply
Pharmaceutical
Development
Clinical
Technologies
Analytical
Services
Commercial
Services
DELIVERYDEVELOPMENTDISCOVERY
Almac Group
4200+EMPLOYEESG L O B A L LY
1850+IN CLINICALS E R V I C E S
635+IN CL IN ICALTECHNOLOGIES
Almac is a privately owned, global drug
development services provider.
Our mission is to be your partner of choice,
providing an expanding array of innovative
Clinical Solutions worldwide.
Clinical
Technologies
February 16, 2016
4
Almac Global Clinical & Technology Solutions
US Packaging (primary/
secondary
Global distribution
Supply Chain Management
IRT Build, Design, Support
EuropePackaging (primary/
secondary
Global distribution
Supply Chain Management
IXRS Build, Design, Support
Japan
Project Lead
Supply Chain Management
IXRS Build, Design, Support
Singapore (APAC)
Packaging (primary/ secondary)
APAC distribution
Global reach, Local Expertise
Supply Chain Management
IXRS Build, Design, Support
February 16, 2016
5
In Just The Last Two Years…
*
* According to Frost & Sullivan 2015
February 16, 2016
Cost to bring a new drug to market: $1 billion
6
Example of Almac’s Contribution
February 16, 2016
7
$ Multimillion Investment in a
State of the Art Platform
• Faster development / shorter time to go live
2 to 6 week build
• Easier / faster adjustments to reflect protocol
amendments
• Users “control their own destiny” via access to
administrative functions
• Most efficient user workflows of any IRT
• Takes information sharing and reporting to the
next level
• Any Device, Anywhere Responsive Design
Improved Visibility & Control Over Your Clinical Trial
without Sacrificing Quality & SpeedFebruary 16, 2016
8
Shameless Plug
• http://www.almacgroup.com/careers
February 16, 2016
Adopting Agile Scrum in a Regulated Industry
Deb Kandebo
February 16, 2016
10
Roadmap
• Introduction
• Business Problem
• Background
• Attributes of a
Successful
Implementation
February 16, 2016
11
Introduction
• State–of-Scrum
–The Scrum Alliance released the 2013 report:
“The State of Scrum: Benchmarks and Guidelines”
The report gleans insights from approximately 500
participants spread across 70 countries.
– 33% of potentially regulated industries practice Scrum
• Finance
• Healthcare
• Aerospace
February 16, 2016
12
Introduction
The Association for the Advancement of Medical Instrumentation
(AAMI) has produced a new Technical Information Report, TIR45, which
provides the following guidance on the use of agile practices in medical
device software development .
• Apply the values of AGILE in a way that enhances a robust quality
management system.
• Apply the practices of AGILE within the context of an established quality
management system.
• Set the correct expectations by defining the SOFTWARE DEVELOPMENT
LIFECYCLE MODEL. Demonstrate how an INCREMENTAL/EVOLUTIONARY
lifecycle satisfies regulatory requirements.
• Establish robust change management systems to manage changes and
mitigate risks associated with change.
February 16, 2016
13
Business Problem
• Why adopt Scrum in a regulated industry?
— Increasing frequency of regulation changes and
client initiated changes
— Increasing focus on quality
— Increasing, constant pressure from clients to
deliver faster and more often
February 16, 2016
Background
14
• Agile Manifesto
Individuals and interactions OVER Processes and tools
Working software OVER Comprehensive documentation
Customer collaboration OVER Contract negotiation
Responding to change OVER Following a plan
All statements in the Manifesto are required on both sides of the statement. In a regulated environment, it is very important that due diligence be applied to the right side of the Manifesto.
15
Implementation of ScrumIn a Regulated Environment
• Regulatory control consists of 2 main models:
– Prescriptive
• Regulations define what must be done and how it is to
be done
– Descriptive
• Regulations define what must be done and ‘leave the
how to be done’ to be determined by the regulated
organization
February 16, 2016
16
What do We Need to do to be Successful?
• Honesty and transparency at all levels
• Partnerships with SMEs, quality management and customers
• Teamwork and trust
• Communication and collaboration excellence
• Confidence in your team members’ creativity and judgment
February 16, 2016
17
What do We Need to do to be Successful?
• In regulated environments, Scrum
highlights those attributes that are key
– A higher level of traceability is achieved by
documenting the relationships between requirements and
other development artifacts
– A higher level of transparency and visibility is achieved by quantifying the remaining work in a burn down chart to enable
management proactive, not reactive, strategic decision making.
– A higher level of transparency is expressed by
the Scrum Definition of DoneFebruary 16, 2016
18
What do We Need to do to be Successful?
• In regulated environments, Scrum highlights those
attributes that are key
– A robust change management system to manage changes and
mitigate risks associated with change
Here ‘change’ can mean: changing regulations, or changing
regulation deadlines, or the client changing the requirements
February 16, 2016
19
What do We Need to do to be Successful?
• Continuous Growth and Maturity
– Perform a retrospective examining 5 key areas:
• Clarity
• Performance
• Foundation
• Culture
• Leadership
– Almac is piloting the use of the Agile Health Radar Tool
– http://www.agilityhealthradar.com/
February 16, 2016
20
What do We Need to do to be Successful?
• Continuous Improvement
– Next Logical Step
• Agile Kanban for maintenance projects
• Both Scrum and Kanban are unique and emphasize more
productivity with quality and efficiency for business.
February 16, 2016
21
To Conclude
• In highly regulated industries where
– Safety is key and
– Executives are highly risk adverse
• Visibility, transparency, traceability attributes inherent to Scrum
– Enhance the safety concerns
– Endorse quick project risk identification
February 16, 2016
Managing Delivery Risk
Gary Dampman
February 16, 2016
23
Meeting Agenda
– The Delivery Risk Model
– Managing the Program
– The Delivery Risk Metric
– The Nuts and Bolts
– Managing the Risk Trends
– Risk Mitigation Plans
– Advantages
– Disadvantages
– Conclusion
February 16, 2016
24
February 16, 2016
• The objective of a Delivery Risk Model is to provide the following;
– Identify tactical impediments to software delivery that need attention.
– Identify trending potential impediments to software delivery that might
need attention.
– Identify and classify any risks that need monitoring and mitigation.
• The Delivery Risk model is designed to show early warning if the train is
running off the tracks!
The Delivery Risk Model
25
February 16, 2016
• The Dashboard assess the
following key factors;
– Scope Status
– Resource Status
– Delivery Status
• Provides a weekly snapshot
of the projects within the
release.
• Includes Operational
Readiness planning.
– QA Certification required.
Managing the Program
A Dashboard RAG is used to provide status of risk across all
projects slated for the proposed release.
26
The delivery risk chart enables the team to trend events
over the time of the release.
February 16, 2016
• Similar to a burn down chart
– Each iteration is listed on
the x-axis.
– The y-axis shows the
deviation in use case burn
down from the expected
velocity.
• Measures the Goal divide by
the Actual work completed.
• Watermarks the percentages
to establish the RAG status.
• The impact of the risk is
broken down by role.
The Delivery Risk Metric
27
What are the prerequisites for using the Delivery Risk Metric?
February 16, 2016
• Starts with the team
– Teams are divided up by feature.
• Scope must be understood
– Initial Story Point estimates are provided
• Team provides a Release Plan
– Iterations are then determined (norm 2wks)
– Story Points are revisited during planning.
• Technical Debt is factored into the metric
– New UC’s, CR’s, bugs, re-estimates &
refactoring.
The Nuts and Bolts
28
The team constantly evaluates the trending risks to avoid
issues towards the end of the project.
February 16, 2016
• The rules of the game:
– Red is to act on mitigation plans.
– Amber is to monitor and plan for mitigation.
– Green means that no action is required.
• To track and watermark the deviations across
iterations.
– Provides a holistic view of how we are tracking
against the target delivery date.
• More interested in the deviations around the ideal
burn down rather than the burn down itself.
Managing the Risk Trends
29
February 16, 2016
• Risk is classified by probability
of occurrence & impact should it
occur.
• Strategies are in place for
dealing with the risk should it
happen.
• Maintained daily and reviewed
weekly.
• Avoiding the “Happy Path” of
optimism.
Risk Mitigation Plans
A Risk register is used to gauge the risks that the team
needs to overcome in order to keep the project on track.
30
Delivery Risk Management IS
February 16, 2016
• A means to visualize current delivery status and risks.
• A means to visualize trending status to allow staff to react earlier.
• A means to ensure that all development activities get appropriate
capacity attention, especially testing.
• A vehicle to identify process improvements as part of a continuous
improvement discipline.
Advantages
31
Delivery Risk Management IS NOT
February 16, 2016
• An exact science.
– It is intended to identify risks and mitigation early. The model is
deliberately organic and depends upon the combination of data, insight,
and trust.
• A team or project performance metric.
– It should never be used as part of formal goal planning for individuals or
teams. Nor should it be used as a mechanism to punish or intimidate
teams or individuals.
• A magic bullet.
– It can help you limit project overruns but may not help you avoid them
altogether.
Disadvantages
32
Delivery Risk final remarks:
February 16, 2016
• It is an aid to getting projects completed on
time while mitigating the risks to quality.
• It helps make the most efficient use of a
software development organization that
translates directly to cost efficiency.
• It promotes open and honest communication
with a common commitment to delivering
great software.
Conclusion
33
Question and Answer
February 16, 2016