Challenges (Obstacles )of

Managing Change
Ch.2
 Introduction
• Change is an inevitable part of an
organization's life cycle, but that doesn’t mean
it goes off without a hitch. In fact, according to
the Australian Human Resources Institute
(AHRI), 70 per cent of change programs are
unsuccessful.
• In a follow-up survey, nearly 90 per cent of
respondents said leadership is mostly to blame
for these failures.
 7 Main Challenges of Leading
1) Managing multiple teams
2) Differentiating the needs of multiple sites
3) Updating appropriate documents to align
with change processes
4) Juggling multiple simultaneous changes
5) Lacking visibility into your change processes
6) Reversing a problematic or ineffective change
7) Quickly gaining appropriate approvals
 Managing multiple teams

• In regulated environments including those in the

Life Sciences, quality system requirements spark
countless touch points for documenting changes,
investigations, root causes, and more.
• Part of these processes tie into actual documents
—your standard operating procedures (SOPs),
work instructions, policies, etc.—and part alludes
to the actual changes to processes or products.
 Managing multiple teams

• A change management software solution designed for

organizations like yours—medical devices
manufacturers, pharmaceutical manufacturers,
biologics and combination products developers—
includes best-practice logic for managing multiple
teams. Does your QA team manage global quality
throughout your organization? Do you have different
regulatory teams in different countries? A good solution
for managing change contains this logic to easily assign
the right teams to the right change processes.
 Differentiating the needs of multiple sites

• Does your organization operate across multiple

sites? What if you uncover a nonconformance or
deviation and need to update your processes at two
out of seven sites, based on the supplies they are
receiving for a particular product? This challenge can
cause chaos if you are ill-equipped to manage your
sites separately sometimes, and symbiotically some
other times. With the right solution, you can easily
identify which sites are affected by a change and
either align them or separate them as needed.
Updating appropriate documents to align with change processes

• As we all know, documents are central to our

processes, and we need them to be tightly
controlled, appropriately reviewed, and
incorporate adequate audit trails. A highly-
effective change management solution will
keep all changes well-documented and
transparent, particularly when it comes to
documents.
 Juggling multiple simultaneous changes

• What do you do when a complaint comes in,

leading to identifying an issue with your supplier?
The changes start to feel like a domino effect: a
corrective action preventive action (CAPA) is
created, requiring an update to your SOPs; now you
might need to change your incoming materials,
tweak your design, or inspect your facilities more
frequently; your packaging and labeling need to be
corrected; who knows how many changes will result
daily, weekly, or monthly?
 Operating multiple immediate changes

• The way to overcome the challenge of managing

multiple, varying changes, is through harmonized
processes. Tracking every controlled change,
assessing its impact, and effectively implementing
changes consistently, every time, is the answer. You
should also look for a system with simple, meaningful
dashboard visibility into open tasks, and email alerts
to keep everyone on track to complete his or her part
of the process. These built-in best practices will help
you solve this, and many change challenges.
 Lacking visibility into your change processes

• Just as dashboards and email alerts help with keeping

your processes harmonized and consistent, they can solve
the dilemma of losing sight of where you are. A well-
planned change can take time to roll out through an
organization, particularly in global environments. That’s
why you need a centralized system for viewing open tasks,
and which phase your change is in. Has QA not approved
a change while the owning department has? With this
knowledge at your disposal, you can follow-up sooner to
ensure you’re making compliance-driven decisions to
minimize risk in your organization.
Reversing to a problematic or ineffective change

• All the planning, prep work, and impact assessments in

the world do not guarantee an effective result 100% of
the time. Having a contingency plan keeps you prepared
for unforeseen events. This can happen when
implementing a new system, introducing new software,
or simply modifying any of your processes. Hand-in-hand
with managing changes, a solution that incorporates roll-
back functionality helps you effectively plan, assess, and
implement a roll back plan in any situation to reset your
quality system or your environment to its prior state.
 Quickly gaining appropriate approvals

• There’s nothing worse than finishing something

and waiting for approval so you can wrap up
your project. This applies to implementing
changes. Your organization may require an
approval from the process owner and by QA.
The right automated system can automatically
route your tasks for the appropriate approvals,
with rules for overdue tasks and escalations.
This helps keep everyone on track.
 To conclude Main three Challenges
(obstacles )
• 1) Employee anxiety
• 2) Force of habit
• 3) Confusion and uncertainty