Presentation by Casey Dusenbery, Vice President, RD&E, Ecolab, Speaker at the marcus evans Medical Device R&D Summit held in Pasadena California June 2017.

1. MANAGING PROJECTS THROUGH
MAJOR QUALITY CHANGES
CASEY DUSENBERY
20 June 2017
VICE PRESIDENT, RD&E ECOLAB HEALTHCARE

3. Why Should R&D Care About Quality System
Changes?
People/Culture Portfolio
Short-Term • Need to avoid team and
project leader frustration
and/or confusion
• Need to demonstrate support
and drive credibility for the
new system
• Need to maintain progress
against the projects and
portfolio
• Portfolio chaos (lack of
predictability) needs to be
avoided
Long-Term • The experience of the R&D
team transition to a new
system can impact the quality
and adoption of that system
• Direct involvement of
developing the quality system
will improve R&D buy-in and
adoption of the new system
• R&D involvement in the
system design can improve
the efficacy and usability of the
new system
• R&D leadership can leverage
the new quality system to
make the future portfolio run
more smoothly
Specifically, speaking about systems that impact R&D the most (design control,
change control, risk management, etc.)

4. R&D Leadership Role during Quality Changes

5. R&D Leadership Continuous Involvement
Throughout the Quality Change is Required
Working Team
R&D
organization
Stakeholders
Business
Results
Quality
Systems
Portfolio
Management
Change
Management

6. Organizational Considerations
What level can you afford to resource from R&D?
Political considerations—what should/will R&D own/do?
Resource considerations—what is the impact to the portfolio?
Capability considerations—new/inexperienced team members may
be more easily available but perhaps don’t have the perspective
and/or experience required to have solid impact
What areas of this quality system are the most impactful to
R&D? Ensure that these are covered by the right people
on your team
Where do you need influence over content (effective documents)
Where do you need influence over format (useable documents)
Who on your team is best equipped to provide input and
influence these areas?

7. Change Management
Key Questions… Which drive…
Is the quality team responsible for this
effort capable to drive change? What is
their level of organizational credibility?
• Stakeholders level of involvement
• R&D experience and empowerment
level required
• R&D leadership involvement required
Is the transition going to be an abrupt
change or an evolution?
• Communication strategy
• Preparation of the R&D organization
What other business initiatives are
going on that could impact this change,
or compound issues?
• Implementation timing
• Staging of change projects
Will this system require long-term
support from R&D, or is it simply an
improvement project with a defined
end?
• Selection of the right team members
• Short-term and long-term structure of
the team

8. Working Team Suggestions
Define Roles/Responsibilities
Who is on the team from R&D? What is their specific role?
Who are the R&D stakeholders?
What is R&D team member decision making authority?
What is R&D stakeholder decision making authority?
Team size must have sufficient knowledge and experience,
but small enough to make progress efficiently
Complexity and timing of the quality change will impact the
resource needs
In some cases, a long-term expert from R&D may be required in
order to keep things progressing while a large, complex system gets
updated

9. Minimize the Risk to the Portfolio Up Front
View the system change in the context of the total portfolio, and the
most important individual projects
Cross-reference the project timelines with the quality system implementation
timelines on a regular basis
Can you influence timing of the changes to ensure success overall or for the
most critical projects?
Revisit the portfolio and the progress of the quality change frequently to
ensure no surprises for your most critical projects
Build in flexibility from the beginning to allow for projects to progress if
and when the quality system changes are delayed so that projects
aren’t completely stalled

10. R&D Should Be Part of System Design
Continuous and direct involvement throughout the design
drives many benefits
Immediate feedback to keep the system useable from the beginning
Alignment is achieved much more quickly
Drives credibility across the R&D organization if they know one of
their peers is involved
The need for subject matter experts is more quickly identified
Identifying and describing the overall architecture may help
with portfolio management and implementation planning
Groups of documents could roll out together
Groups of projects could transition together
The portfolio needs could potentially drive the implementation timing
if there is a particularly critical project or business need that cannot
be delayed by quality system changes

11. Communication will Make or Break It
Communication to the broader R&D organization is
important from the beginning to build alignment and
credibility
What is changing?
When is it changing?
What can the project teams expect?
To the stakeholders
How will this change impact business results?
Timeline and metrics to be tracked?
How will updates be given?
Escalation plan when the team is struggling to make a decision
Communication of the intent of the change(s) can go a long
way towards buy-in and adoption

12. Implementation Is the Hardest Part
Implementation planning should start early and be revisited
often
The ability to describe to the overall organization what to expect will
smooth the path significantly
“A team can generally deal with uncertainty in the overall system if
they at least know how to move their documents and project forward.”
–Manager, New Products team
Consider the opportunity to pilot large pieces of the new
system
Allows quick and easy changes without losing credibility
Creation of examples or best practice guidelines from real-life
experience benefits all users

13. Implementation
In complex systems such as design control, thoughtfully
release the templates, SOPs, WIs, etc. so the released
portions are executable
When releasing, always show the schedule of what is coming next
so the teams can plan
Clear expectations is important; vague descriptions or blank free fill
is not sufficient with new systems
It will never be perfect, so carefully weigh minor updates and their
value
Alignment on when and how to use the new documents
must be very clearly defined and tracked
How do we measure compliance during the transition?
If the timeline shifts, revisit the plan so that the projects are not stuck
Prevents delays from team uncertainty and re-work

14. In-Flight Projects
Document which projects will transition to which piece of
the new system by when at a very detailed level
Communicate the plan for in-flight projects across all
functions and ensure alignment on a regular basis
Compliance AND quality of documents across both systems
Stay engaged in this piece to help manage
Timeline shifts
New people/new positions

15. Project leaders-”How will this affect my
project?”
Managing a project is hard. Managing a project within 2
quality systems is nearly impossible. Clear direction and
expectations for individual projects is important.
Cross-functional alignment is key
Flexibility if the project leader gets stuck between systems
Understanding status and details of system change
without becoming too involved is a challenge for many
project leaders. Over-communicate without dragging
everyone into every discussion!

16. Training
In major quality changes, there is no such thing as too
much training!
Suggested approaches:
Active training sessions vs. “send out the documents”
Provide examples of what “good” looks like
Even if training on a specific subset of the system, refer to the overall
architecture and how it fits together so that the trainees can
understand the full picture
Release and train on groups that go together for efficiency, and for
improved outcomes
As the R&D leader, it is imperative that you oversee the
training to ensure that it is sufficient for your team to be
successful

17. Tips for managing the transition
As an R&D leader, stay connected at least to the big picture
of progress to help identify sticking points and be able to
coach/guide when needed
Culture and team buy-in is hard to win and easy to lose.
Awareness of how the working team is perceived and when
intervention may be needed is critical
Constant feedback loops as people adopt the new system,
and a “steering team” can ease the transition
While not a popular option, it happens…
When it appears the team is over their head, or the quality system
transition is going to take much longer than expected, go to Plan B
and drive from R&D

18. Beyond R&D
Proactive management of the pendulum swings that often
happen during quality upgrades can pay off big
Helping the business leaders understand the potential
impact can prepare them to help drive alignment if needed
Help the project leader understand whether they need to
adjust their expectations for number of meetings or amount
of time required to complete a task
Does this new system require more time from cross-functional team
members?
Establish the project leaders’ role in the implementation to
understand the expectations for making the new system
work in cross-functional teams
Does the project leader need to teach their team members?

19. Lessons Learned
1. Document decisions at a level that seems ridiculous
2. Over-communicate with the broader team, not just the
project leaders that are currently impacted
3. Don’t let too many cooks in the kitchen during system
design
4. Paint the picture for the team to understand that this is
short-term pain for long-term gain
5. Be very clear about the expectations of the project teams
during the transition time period and post-implementation
6. Roll-out of changes with matter of fact explanations of
intent and value (not emotional attachment)
7. Anticipating the impact of these changes ahead of time
will help with planning implementation and reacting to
challenges
8. Keep reminding the organization what success looks like

20. R&D Benefits
Enhanced quality systems truly do benefit R&D when we
are involved from the beginning
The combination of input to improve the process and
usability of the quality documents can go a long way
towards advancing your portfolio
If you can build in efficiency while designing the quality
system, it will benefit the R&D team and the business
Flipping from being the victim of quality changes to being a
driver of improvements can help team engagement and
productivity across all of R&D

21. QUESTIONS?

22. 22
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