Pharmaceutical Commerce - July/August 2017 - 26

Manufacturing & Packaging

Digital Factory Transformation beyond Serialization Compliance
continued from page 24

Tracker would be the answer to uncover and
remedy many of their issues, highlighting
a re a s of i m m e d i a te a n d s i g n i f i c a n t
By replacing manual and/or paper-based
tracking activities with that of digital tracking
capabilities, the biggest improvement
happened in operational visibility. Our
clients started seeing live dashboards of their
operations, unexpected stops and delays in
production, as well as the root causes of these
issues (e.g., specific machines in a line). Once
the solution was implemented at multiple
lines, it also provided a capability to compare
and contrast similar lines, their efficiency
levels and emerging problems by consistently
measuring and tracking the operations across
these lines.
The second biggest source of improvement
came with a "moment of revelation" when
certain procedure-driven activities showed
significant variability in duration during
the initial pilot study. Our client started
noticing areas of variability, together with
the identified sources of variability, which
helped improve the tracking capabilities of
the solution to clearly identify and capture
the root causes of these variabilities. For

example, the number of available operators
it takes to conduct a certain procedure is
an important input to capture, which often
correlates significantly with the duration of
those procedures.
Once the visibility and newly found
capability of variability tracking were put
in place, then came the definition of what
is regular or acceptable, and what is an
exception. Most of the activities tracked could
be assigned an expected duration, a possible
minimum and a maximum allowed duration
(i.e., lower and upper limits). Algorithms
automating the reporting of exceptions (i.e.,
below minimum or above maximum), made
it an easy task to get daily or weekly digest
emails highlighting just the exceptions for
managers to focus on.
Through deep collaboration and datadriven discussions, another important area
for troubleshooting was identified as the time
it takes to find the right personnel to conduct
their duty when required at a given line. For
example, bringing the right quality assurance
(QA) personnel to release the line after it
has been cleaned could sometimes take up
to an hour or more of wait time. Similarly,
finding the right mechanic and making him

come to the line to fix an issue could take
significant time, causing additional line
stoppage. A simple "call support" function
implemented in the OEE Tracker solution,
emailing/texting the right person with the
right information, significantly reduced this
avoidable downtime.
The real improvement in efficiency is not
possible until a true change of operational
behavior is achieved. Being digitally tracked
already contributed to our client's OEE
performance, where without any policy
change, an improvement of 10-15%
is achieved by the change in behavior
of super v isors and oper ators. More
fundamental performance improvement,
however, required a new look at the way the
work orders are scheduled to the lines to
minimize overtime and reduce changeovers.
Given a digitally strong foundation of
OEE Tracker and digital log book of all
shop floor activities, a more robust way
of creating the shop floor schedule was
created. Early results from the analysis
of actual monthly schedule data showed
very promising results with a 10-20%
reduction in labor cost, primarily due to
reduced overtime, and a possible increase in
capacity/throughput of 20-40% with better
scheduling capabilities using mathematical

modeling and machine-learning algorithms
to use constantly improving data-sets for
In all, our work with our client improved
the way they manage their packaging
operations. After using our OEE Tracker
solution, they could quickly highlight
areas that impede productivity, as well as
calculate and utilize metrics on their line
operations for improved efficiency. Having
worked extensively with our client, we have
concluded that, while data is important,
all three aspects of "3D"-including
dashboards for operational insig hts
and decisions for actual step change in
behavior-must work together to form
a complete solution, one that we know
is possible with the support of software
solutions, IoT sensors, and an open-minded
and supportive leadership.
The Digital Factory Transformation
journey could be new to many companies
and sites, however, with the serialization
compliance requirements and side effects
on efficiency, more and more companies
will embark upon this journey in the near

Legal & Regulatory

Managing employee training at the enterprise level
continued from page 25

CRM and LMS are used separately in a silo,
the reports generated offer only a fractional
view of an individual's performance. By
combining the data and information
from multiple systems, the outcome and
insight is exponential, and far richer data
can be leveraged to improve results along
the spectrum. Proper integration can also
remove redundant manual efforts that can
be time-consuming and labor-intensive.
* Compliance risks can be minimized,
as employees are tracked across all areas, and
"compliance education overlap" is greatly
reduced. When a company is reducing risk

by aligning with standards and complying
with regulations, those responsible for
compliance training will push out training
focused on changing rules, regulations and
policies. If the curriculum is not centralized,
then redundancies, and even gaps, can
emerge that can threaten the effectiveness of
the program and introduce risk.
Timely analysis of the curriculum that
is customized by department and realigned
when necessary will help ensure that
proper training is being given to the right
people at the right time.

Perhaps the most important benefit from
an enterprise-wide learning system and
balanced training system is that managers
can conveniently share data across the
enterprise, especially in areas of career
development and compliance status. What
this does is provide decisionmakers with
better data and greater insights-within a
unified and cohesive system environment.
With a single solution, leaders can visualize
relationships and patter ns between
operational and business activities in new
and extremely valuable ways. Companies
will more effectively see connections

to problems and solutions as they are
unfolding. In highly regulated business
environments, finding these correlations,
the single appropriate enterprise-wide
learning plan and the ideal LMS solution is
more important than ever.
Isabelle Noblanc is vice president and
general manager of UL Compliance to

Top News

Walgreens-Rite Aid merger falls away, replaced by sale of
some stores
continued from page 9

to maximize revenues while they retain
patents on new drugs). The J&J acquisition
of Actelion, for $30 billion, occurred early

this year, but otherwise it's been relatively
quiet. Pfizer's unsuccessful bid to purchase
Allergan (which would have been an eye-

26 Visit our website at July | August 2017

popping $160-billion deal) is a little over a
year old; it went on to purchase Medivation
later in 2016. With Federal Reserve interest

rates rising, and the continuing turmoil over
federal health insurance policy, a wait-andsee attitude seems to be today's norm.

Table of Contents for the Digital Edition of Pharmaceutical Commerce - July/August 2017

Table of Contents
Pharmaceutical Commerce - July/August 2017 - Cover1
Pharmaceutical Commerce - July/August 2017 - Cover2
Pharmaceutical Commerce - July/August 2017 - Table of Contents
Pharmaceutical Commerce - July/August 2017 - 4
Pharmaceutical Commerce - July/August 2017 - 5
Pharmaceutical Commerce - July/August 2017 - 6
Pharmaceutical Commerce - July/August 2017 - 7
Pharmaceutical Commerce - July/August 2017 - 8
Pharmaceutical Commerce - July/August 2017 - 9
Pharmaceutical Commerce - July/August 2017 - 10
Pharmaceutical Commerce - July/August 2017 - 11
Pharmaceutical Commerce - July/August 2017 - 12
Pharmaceutical Commerce - July/August 2017 - 13
Pharmaceutical Commerce - July/August 2017 - 14
Pharmaceutical Commerce - July/August 2017 - 15
Pharmaceutical Commerce - July/August 2017 - 16
Pharmaceutical Commerce - July/August 2017 - 17
Pharmaceutical Commerce - July/August 2017 - 18
Pharmaceutical Commerce - July/August 2017 - 19
Pharmaceutical Commerce - July/August 2017 - 20
Pharmaceutical Commerce - July/August 2017 - 21
Pharmaceutical Commerce - July/August 2017 - 22
Pharmaceutical Commerce - July/August 2017 - 23
Pharmaceutical Commerce - July/August 2017 - 24
Pharmaceutical Commerce - July/August 2017 - 25
Pharmaceutical Commerce - July/August 2017 - 26
Pharmaceutical Commerce - July/August 2017 - 27
Pharmaceutical Commerce - July/August 2017 - Cover4