adopting agile scrum in a regulated...

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


IXRS Build, Design, Support

Japan

Project Lead



Singapore (APAC)

Packaging (primary/ secondary)

APAC distribution

Global reach, Local Expertise



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


• 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


• 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


• 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


• 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

adopting agile scrum in a regulated...

Documents