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UA Online PMDAY 2021
Making Agile Easier
Coaching the Enabling Organizations for Agile
Transformation
Mike Palladino, PMP, CSM, ATP Instructor, SAFe
- Director, Agile Center of Excellence, Bristol Myers Squibb
- Adjunct Professor, Villanova University
- Author, Data Management University
- Past President, PMI-DVC chapter
Context
UA Online PMDay 2021 2
Agile
Teams
Procurement
Validation Security
Human
Resources
Legal
Finance
Enabling
Organizations
• Procurement • Finance • Validation
UA Online PMDay 2021 3
Who Will be Impacted
PROCUREMENT
UA Online PMDay 2021 4
5
Compare the Approaches for Contracts
Traditional Contract Agile Contract
List all deliverables.
A lot of detail
Only high-level deliverables.
Define process to develop details
Focus on disagreements & penalties Focus on collaboration
Lack of trust Requires trust and grows trust
Focus on only this contract Focus on future work as well as this contract
Contract dates are defined. Difficult
to adjust
May finish sooner or later than original date.
Both sides share the risk
Hard to incorporate change Easy to incorporate change
UA Online PMDay 2021
New Approach – Key Elements
UA Online PMDay 2021 6
• Master Service Agreement (MSA)
• Separate from deliverables
Separate
• Keep scope at high level
• Not detailed deliverables
Scope
• Define process
• Not detailed deliverables
Process
• High Level Acceptance
Acceptance
• Not Fixed Price
Time & Material
• Share the benefits
• Share the losses
Share
On-going Cycles
UA Online PMDay 2021 7
Review
Q1
Create
Q2
Review
Q2
Create
Q3
Review
Q3
Create
Q4
Review
Q4
Create
Q1
Year 1
Year 2
12/2020
Create
Q1
3/2021 6/2021 9/2021 12/2021
Review
Q1
Create
Q2
3/2022
…
Continue
Additional Information
UA Online PMDay 2021 8
Design an Agile Contract
• https://www.villanovau.com/resources/contract-management/how-to-design-an-
agile-contract/
• Allow changes
• Transparency is key
• Leave room for updates
Agile Contracts Primer
• https://agilecontracts.org/agile_contracts_primer.pdf
• Written for lawyers and Agile practitioners
• Derived from the book... Practices for Scaling Lean & Agile Development:
Large, Multisite, & Offshore Product Development with Large-Scale Scrum
• by Tom Arbogast, Craig Larman, and Bas Vodde
FINANCE
UA Online PMDay 2021 9
Typical project with depreciation
UA Online PMDay 2021 10
$4M $4M $4M
Benefits
- Spread out the expense
- Offset future income
- Saves taxes
2 Year Project $12M
3-year depreciation
1/3 each year = $12/3 = $4M
Year 1 Year 2
Year 3 Year 4 Year 5
Typical project with depreciation
UA Online PMDay 2021 11
$4M $4M $4M
2 Year Project $12M
Year 1 Year 2
Year 3 Year 4 Year 5
Problem
- Capital/expense ratio is different
- Can impact perceived company value
$12M
All expense in Year 2
Project Canceled
X X X
Financial Impact of Rapid Releases
12
Waterfall
Agile
Start
Release
Begin depreciation
Start
Releases
Partial depreciation for each release
Financial Impact of Rapid Releases
13
Agile
Start
Releases
$
$
$
Per Release
- Labor costs
- Material costs
VALIDATION
UA Online PMDay 2021 14
15
What is validation
What is software validation
Documented evidence that confirms a computer
has been installed correctly and functions
according to its intended use
It works
It works as designed
How to Validate
Record evidence that shows the system was
installed and works as intended
Inspect before software is ran
Inspect while software is running
Actual FDA requirements
Must meet the FDA’s
standards for production
and inventory management
Every step of the
validation process must
be documented
Typically, people run Test Scripts and
take screen captures of each step. Not
effective nor fast.
What is the FDA
Federal Drug Administration
United States government organization that
confirms drugs and medical devices are safe
UA Online PMDay 2021
Validation Plan
UA Online PMDay 2021 16
Validation
1 Create Validation Plan
2 Define System Requirements
3 Create Validation Protocol & Test Specifications
4 Testing
5 Develop/Revise Procedures & Final Report
Waterfall
UA Online PMDay 2021 17
Agile end-to-end use in validated environments
18
Red - No formal effort
in place
Orange - Efforts in
early stages
Yellow - In place in
pockets
Green - In place with
wide use
Solution Life
Cycle (SLC)
Computer System
Validation (CSV)
Tool
Integration
Automated
Testing
DevOps SecOps (or
DevSecOps)
Use of User Stories
for Validation
Risk-based
Validation
IT Quality Management
support for Agile
Enterprise Quality
Management
support for Agile
Auditors support
for Agile
Many pieces must
come together
O O Y
O
R
O
R
G
Y
R
Y
Validation Analogs
19
Batch
manufacturing
Agile
Waterfall
Recipe Make Test Sell
Requirements Build Test Release
Concept Experiment & Test Release
New and Unique
Dessert and
Secret Ingredient
Accept
UA Online PMDay 2021
What to Validate
UA Online PMDay 2021 20
Feature
Epic
Feature Feature
Story Story Story Story Story Story Story
Validate
Conclusion
• As Agile continues to grow, supporting
organizations will need to change, too
• Help them understand Agile
• Learn enough of their business to understand
the impact
• Organizations have been generally positive
• Find someone who is willing to work with you
21
UA Online PMDay 2021
UA Online PMDAY 2021
Thank you!
Questions ???
Comments ???

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Making Agile Easier for Enabling Organizations

  • 1. UA Online PMDAY 2021 Making Agile Easier Coaching the Enabling Organizations for Agile Transformation Mike Palladino, PMP, CSM, ATP Instructor, SAFe - Director, Agile Center of Excellence, Bristol Myers Squibb - Adjunct Professor, Villanova University - Author, Data Management University - Past President, PMI-DVC chapter
  • 2. Context UA Online PMDay 2021 2 Agile Teams Procurement Validation Security Human Resources Legal Finance Enabling Organizations
  • 3. • Procurement • Finance • Validation UA Online PMDay 2021 3 Who Will be Impacted
  • 5. 5 Compare the Approaches for Contracts Traditional Contract Agile Contract List all deliverables. A lot of detail Only high-level deliverables. Define process to develop details Focus on disagreements & penalties Focus on collaboration Lack of trust Requires trust and grows trust Focus on only this contract Focus on future work as well as this contract Contract dates are defined. Difficult to adjust May finish sooner or later than original date. Both sides share the risk Hard to incorporate change Easy to incorporate change UA Online PMDay 2021
  • 6. New Approach – Key Elements UA Online PMDay 2021 6 • Master Service Agreement (MSA) • Separate from deliverables Separate • Keep scope at high level • Not detailed deliverables Scope • Define process • Not detailed deliverables Process • High Level Acceptance Acceptance • Not Fixed Price Time & Material • Share the benefits • Share the losses Share
  • 7. On-going Cycles UA Online PMDay 2021 7 Review Q1 Create Q2 Review Q2 Create Q3 Review Q3 Create Q4 Review Q4 Create Q1 Year 1 Year 2 12/2020 Create Q1 3/2021 6/2021 9/2021 12/2021 Review Q1 Create Q2 3/2022 … Continue
  • 8. Additional Information UA Online PMDay 2021 8 Design an Agile Contract • https://www.villanovau.com/resources/contract-management/how-to-design-an- agile-contract/ • Allow changes • Transparency is key • Leave room for updates Agile Contracts Primer • https://agilecontracts.org/agile_contracts_primer.pdf • Written for lawyers and Agile practitioners • Derived from the book... Practices for Scaling Lean & Agile Development: Large, Multisite, & Offshore Product Development with Large-Scale Scrum • by Tom Arbogast, Craig Larman, and Bas Vodde
  • 10. Typical project with depreciation UA Online PMDay 2021 10 $4M $4M $4M Benefits - Spread out the expense - Offset future income - Saves taxes 2 Year Project $12M 3-year depreciation 1/3 each year = $12/3 = $4M Year 1 Year 2 Year 3 Year 4 Year 5
  • 11. Typical project with depreciation UA Online PMDay 2021 11 $4M $4M $4M 2 Year Project $12M Year 1 Year 2 Year 3 Year 4 Year 5 Problem - Capital/expense ratio is different - Can impact perceived company value $12M All expense in Year 2 Project Canceled X X X
  • 12. Financial Impact of Rapid Releases 12 Waterfall Agile Start Release Begin depreciation Start Releases Partial depreciation for each release
  • 13. Financial Impact of Rapid Releases 13 Agile Start Releases $ $ $ Per Release - Labor costs - Material costs
  • 15. 15 What is validation What is software validation Documented evidence that confirms a computer has been installed correctly and functions according to its intended use It works It works as designed How to Validate Record evidence that shows the system was installed and works as intended Inspect before software is ran Inspect while software is running Actual FDA requirements Must meet the FDA’s standards for production and inventory management Every step of the validation process must be documented Typically, people run Test Scripts and take screen captures of each step. Not effective nor fast. What is the FDA Federal Drug Administration United States government organization that confirms drugs and medical devices are safe UA Online PMDay 2021
  • 16. Validation Plan UA Online PMDay 2021 16 Validation 1 Create Validation Plan 2 Define System Requirements 3 Create Validation Protocol & Test Specifications 4 Testing 5 Develop/Revise Procedures & Final Report
  • 18. Agile end-to-end use in validated environments 18 Red - No formal effort in place Orange - Efforts in early stages Yellow - In place in pockets Green - In place with wide use Solution Life Cycle (SLC) Computer System Validation (CSV) Tool Integration Automated Testing DevOps SecOps (or DevSecOps) Use of User Stories for Validation Risk-based Validation IT Quality Management support for Agile Enterprise Quality Management support for Agile Auditors support for Agile Many pieces must come together O O Y O R O R G Y R Y
  • 19. Validation Analogs 19 Batch manufacturing Agile Waterfall Recipe Make Test Sell Requirements Build Test Release Concept Experiment & Test Release New and Unique Dessert and Secret Ingredient Accept UA Online PMDay 2021
  • 20. What to Validate UA Online PMDay 2021 20 Feature Epic Feature Feature Story Story Story Story Story Story Story Validate
  • 21. Conclusion • As Agile continues to grow, supporting organizations will need to change, too • Help them understand Agile • Learn enough of their business to understand the impact • Organizations have been generally positive • Find someone who is willing to work with you 21 UA Online PMDay 2021
  • 22. UA Online PMDAY 2021 Thank you! Questions ??? Comments ???

Editor's Notes

  1. Procurement / Purchasing Writing contracts Finance Capitalization & Depreciation Calculate value Validation Rethinking validation
  2. Data protections, liability, termination
  3. Dyakuyu