26 • ODT odtmag.com May/June 2016
Assemble Your Crisis Management Kit Now Before You Need It
Dawn A. Lissy • President and Founder, Empirical Testing Corp.
As a small business owner, I know first hand that unexpected events can turn your business upside
down in a moment. Over the past 18
years, we have had several unexpected
events that could have endangered the
quality of service to our clients or even the
continued existence of Empirical.
Whether it was the electricity on the city
block being taken out by a driver crashing
into a utility pole housing the transformer,
or navigating through a series of calamities
that led me back to work three days after
giving birth to my oldest son, running a
group of companies has meant unpredictable events lurk around every corner.
Your business, however, not only can
survive but potentially grow from these
crises if you’re properly prepared. Not that
we can brace for every possible outcome,
but it is possible to minimize damage with
the right management tools. I turned to
our in-house expert on crisis management
for some tips on what any business can do
to keep stable during tough times.
Meredith May, MS, RAC, CQA, is vice-president of Empirical Consulting, part of
the family of Empirical companies. She
recently authored a chapter on crisis management for the guide “Fundamentals of
U.S. Regulatory Affairs—Ninth Edition,”
published by the Regulatory Affairs Professionals Society. She’s not just my top
regulatory expert—she developed the crisis
management strategy for all three of our
companies (Empirical Testing Corp., Empirical Consulting, and Empirical Machine).
May is a devout believer in the five
Ps: Prior planning prevents poor performance. We like to ask her to say this as
quickly as possible five times in a row.
“When you’ve prepped and organized,
people can step into their roles and start
dealing with the crisis without the ini-
tial panic phase, during which the crisis
typically deepens,” she said.“If you have a
plan, if you know what to do, you move
into action, not panic.”
She recommends putting together
what she calls a crisis management kit
with the help of relevant team members,
preferably employees with a broad range
of experience. It’s a group effort based on
a lot of brainstorming and research. Quiz
your team members about the worst cri-
ses they’ve dealt with over the course of
their careers and how they handled them.
Research potential issues based on your
company’s services or products as well as
your specific industry so you have an idea
of what could go wrong and how to react,
or even what not to do.
“You need to know where all the weak
points are for your business and also for
your industry,” May said. “You’re really
coming at it from two different perspec-
tives: internal and external. Do some soul-
searching and be honest about where your
For example, if your company produces
metal hip implants, you want to know not
just the failure points of your specific de-
vice, but also the ins and outs of metal-on-
metal wear and how that issue has affected
that particular market segment. If your
company focuses on regulatory issues, read
up on what’s triggering recalls, warning let-
ters, and other potential blocks to market.
An example of an internal crisis would
be equipment breakdown or other disaster
that affects production. An external crisis
could be the loss of a manufacturer that’s
critical to your product. Both can have immediate, catastrophic effects on your ability to conduct your business. Determining
what those potential pitfalls are and how
to address them brings you back to your
brainstorming session with key players.
“In general, you want to bring in your
senior leadership, your managers, and your
vice presidents to do the planning,”May said.
“Pull in people preferably that have multiple
experiences at different companies.”
The results of those brainstorming
sessions will translate into clear plans of ac-
tion for the rest of your company. Regardless
of your specific line of business, May recom-
mends three general areas of crisis planning
for members of the medical device industry:
patient harm, financial, and legal/regulatory.
Consider worst-case scenarios for each type
of crisis and form your crisis management
kit for the top-tier disasters first.
“Once you have come up with your list
of all things that can go wrong, you’re going to prioritize them based on first, ‘Do
you have a weakness in your company
that makes this risk or crisis almost inevitable?’” May continued.
You may want to bring in a consultant to
ensure your focus is broad enough and your
crisis management kit is a solid foundation
for recovery. Consultants will have seen a
wide range of crises at a variety of companies; they’ll have a depth of experience to
draw from that’s likely greater than what
your team can bring to the table because
those consultants work outside of your company. They also don’t have hidden biases or
a personal connection to your work, so their
thinking is often more objective. Spending
the time and money with the right consultant for pre-planning will likely save you
money and stress over the long term.
“You’re better off hiring them up front
for a two-day brainstorming session than
hiring them to deal with a crisis for six
months,” May added.
The hire should be someone who can
help come up with the specific tools needed to address the potential crises identified. This includes a step-by-step action
plan with a checklist for each type of crisis
and delineation of responsibilities (i.e.,
who does what).
May and I both swear by checklists.
When you have a list to run down, it’s
another way to decrease stress and panic.
You don’t have to come up with what to
do in the moment because you have it laid
out in a simple format (Recommended