Feature Report

Operational
Excellence
Begins Here

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Achieve operational excellence in batch processing

through a commitment to improved operational efficiency
Michalle Adkins
Emerson Process Management

he pressures and challenges

placed on the chemical process industries (CPI) have been heralded
so often that even a person on the
street can articulate most of them; and
the list continues to grow cost containment, lawsuits, fewer blockbuster
discoveries, unexpected competitors,
and many more. The cold hard reality is that the CPI have entered into
a tough, cruel business world where
only those companies committed to excellence to becoming the best-of-thebest will enjoy success.
Jack Welch, former CEO of GE, describes excellence like this: To me, excellence means being better than the
best. Its achievement requires an introspective assessment of everything
we do, say, or make, and an honest inquiry: is it better than the best? If it
is not, we will ask ourselves, what will
it take? And then, we will rally the resources required to get there [1].
What Welch and others are describing
and what many companies have begun
to pursue is operational excellence.
According to the online encyclopedia
Wikipedia, Operational excellence is
the goal of conducting business in a
manner that improves quality, obtains
higher yields, faster throughput, and
less waste. Sometimes known as OpX,
operational excellence is the state or
condition of superiority in operations
and execution of business processes.
Many different business tools are used
52

in the pursuit of operational excellence. These tools include Six Sigma,

Lean, Footprint Rationalization and
Premier Resource Management.
Obtaining a state of operational excellence requires applying a holistic
approach that results in integrating
operations management methodologies in ways that optimize people, assets, and processes.
Imagine OpX within your organization similar to the way you view the
wagon wheel in Figure 1. If any single
part of the wheel rim, hub, spoke,
felloes is incapable of performing in
harmony with all the other parts, the
ability of the wheel to continue rolling smoothly and reliably forward is
greatly jeopardized. Translated into
business jargon, if any single area of
your business R&D, production,
quality, sales and service, and so on
is not performing in concert with the
rest of the organization, the ability of
the company to satisfy the shareholders is greatly jeopardized.
All of this begs the question, Where
does it make sense for a company to
begin in order to achieve OpX?

Where to begin

Stephen R. Covey [2] suggests that

beginning with the end in mind is
always an important part of any program or process, and securing management support can be crucial to achieving total success. This is not to belittle
what can be accomplished using available tools without managements support. However, with managements

Chemical Engineering www.che.com March 2007

Figure 1. Each part of the

OpX wagon wheel should
operate in harmony with all
the other parts to ensure
smooth running

backing greater opportunities exist

that can produce astounding results
across the entire organization. Additionally, when management is part of
the process, successes are celebrated,
roadblocks disappear, funding becomes
available, cooperation and consistency
abound, trials and tribulations are less
devastating, and the journey simply
becomes more fun for everyone.
Organizations that are already on
the OpX journey report that different
business functions maintenance,
production, R&D, and so on generally require different methodologies,
tools, skills, and assistance to achieve
a sustainable level of OpX success.
For example, the following questions come to mind: should you apply
the entire Six Sigma toolset, incorporate lean manufacturing, mix parts
and pieces of each to form Lean Six
Sigma, or utilize some other customized approach? If certification is
required, how will the organization
manage each certification? If new
tools and processes are being used to
manage the business on a daily basis,
how and to what extent will training
on these new tools and processes be
rolled out? How do you avoid data
paralysis (gathering more and more
data) and data-anemia (not gathering
enough or the right data)?
Often, especially during preliminary introduction of OpX into various
parts of an organization, the wisdom
and experience of consultants with
domain expertise can save time and
money. Besides having hefty creden-

Summary of the example

Define: reduce release time by 10%
Measure: Time and date stamps on batch records
Analyze: Cause and effect diagrams illustrating contributing events
Improve: Benchmarking and value vtream mapping prioritizing opportunities
Control: Monitor results to ensure expected improvements are being achieved
Table 1. Calculated Savings
for Single Product Intermediate State
Category of savings

Calculated savings

Increase throughput

$425,000

Improve planning process

$4,250

Eliminate paper batch record processing

$102,000

Reduce manpower for batch record execution

$250,000

Reduce manpower for batch record approval

$238,000

Reduce number of deviations

$150,000

Reduce/eliminate paper log books

$8,500

Total savings

$1,177,250

tials that are relevant to the business,

the consultants portfolio should include a library of general guidelines
that can be tailored to fit your organization. For example, by implementing
a guideline that helps to ensure that
the quantity of data collected and analyzed is appropriate for the complexity of the problem, the team quickly
builds confidence and efficiently delivers measurable results.
No doubt you are aware of the many
business-improvement tools available,
such as Six Sigma, Lean Manufacturing, Business-Performance Management, but how do you determine what
tools are most appropriate for successfully injecting OpX into the various
parts of your business, say production?

A practical methodology

One significant portion of the batch

processing industries is the life-sciences industry. When you think about
it, batch processing is an orchestrated
mix of process control (level, flow,
temperature, and so on) and discrete
manufacturing (start/stop, open/close,
transfer, clean, and so on). As a result
of the U.S. Food and Drug Administrations (FDA) Process Analytical Technology initiative, this industry now
has additional demands for ongoing
operational improvements that represent significant new opportunities
that can be applied to batch processing in general. Examples from this industry will be used to illustrate implementation of OpX.
The more successful OpX meth-

odologies being employed for batch

production combine Six Sigma and
Lean Manufacturing. They call this
Lean Six Sigma or S4 (for Smarter Six
Sigma Solutions [3]).
Additional tools that experienced
Lean Six Sigma consultants may
apply include: Value Stream Mapping,
Collaborative Diagrams, Design of Experiments, Business Process Mapping,
Quality Systems, Fishbone Diagrams,
and others.
Lean Six Sigma is actually an adaptation of the traditional Six Sigma
DMAIC (Define, Measure, Analyze,
Implement, Control) methodology
(see, for example, CE November 2003,
pp. 6267) combined with the improvement methods popularized by
Lean Manufacturing and can include
Kaizen, FMEA (Failure Mode and Effects Analysis), DOE (Design of Experiments), and QFD (Quality Function
Deployment).
Certainly the expertise and experience of the consultants you select to
help ensure you correctly commence
your OpX journey is important; however, since twenty-first century businesses are highly dynamic, the tools
the consultant brings and eventually
leaves with your organization need to
easily accommodate change. Be sure
the consultants Lean Six Sigma methodology provides sufficient flexibility
for the consultant to tailor a program
that will accommodate your current
business environment. The methodology should also accommodate being
re-tailored by your employees in order

to address future business environments. Anything short of this degree

of flexibility will eventually hamper
your OpX progress.

Learn by example

As previously stated, operational excellence is a holistic approach to integrating operations management

methodologies in order to optimize
people, assets, and processes.
Concentrated to a single focused
statement, OpX is about increasing
the return on invested capital (ROIC).
In the define (assessment) phase,
ROIC opportunities are identified
as measurable, quantifiable results,
such as:
Increase profitability by 5%
Exceed a 10% return on the invested
capital
Increase RFT (right first time) from
95% to 99.99%
Within the life-science industry in particular, shortening the overall batchcycle time, including the time required
to investigate and resolve processing
discrepancies before the finished product is released for shipment, can have
a significant impact on ROIC within
production, sales and service, and
warehousing and distribution.
In order to illustrate the Lean Six
Sigma methodology, this article will
use an example which is actually a
composite of multiple case histories.
Define (assessment): When commencing a production facility assessment, the goal is to answer (define)
two questions:
1. Of all the improvement opportunities you identify, which one should
you work on first?
2. What tangible results will this opportunity improve?
Once you begin, there are likely to be
many additional improvement opportunities identified, the challenge is
sorting through all these opportunities in order to arrive at the one or two
you must work on first.
In our example, the goal was to reduce the time required to release a
finished product to shipment by 10%.
Among the discussions that helped define the goal are the following:
There is a tremendous amount of
paperwork required in order to release a product

Chemical Engineering www.che.com March 2007

53

Feature Report
Table 2. Calculated Savings for Multi-Product Paperless Future State
Category of savings

Electronic work instructions & in-process

material tracking

Data
integration

Cycle time
improvements

Total by
category

$518,500

$430,000

$0

$948,500

Reduce batch cycle time

$0

$0

$2,040,000

$2,040,000

Reduce batch release cycle time

$0

$0

$714,000

$714,000

$1,105,000

$0

$0

$1,105,000

Minimize operational duplication

$332,000

$485,000

$0

$817,000

Reduce maintenance overtime

$468,000

$0

$0

$468,000

Improve control, monitoring, and reporting

$93,500

$46,800

$0

$140,300

$0

$0

$361,300

$361,300

$204,000

$0

$0

$204,000

Reduce commissioning & startup

$0

$0

$1,190,000

$1,190,000

Total savings:

$2,721,000

$961,800

$4,305,300

$7,988,100

Quality
Improved batch record review and release
Throughput

Availability
Extend calibration cycles
Operations & maintenance

Utilities
Reduce electricity usage
Waste and rework
Eliminate atypical batches
CAPEX Savings

Tracking all the paper is cumbersome

Inventory of WIP (work in progress)
or finished goods is increased
Islands of automation produce islands of data
Inconsistency
of
applications
abound
Manual brute-force efforts are often
used to get product released
While some of these bullets obviously
fit our defined goal, others may not be
so intuitively obvious. For example,
increasing inventory is likely to be
the cushion necessary to meet customer requirements in an environment that is unable to predict how
long it will take to release intermediate product and then release finished
product for shipment.
When each of the discussion topics
were explored in greater detail, every
one emerged as a significant contributor to the time required to release a
finished product for shipment.
For this composite example, the
client/consultant teams developed
collaborative diagrams indicating
the sources of batch-end data, the
data flow paths (including each time
a human physically handled various pieces of data or paper) and the
frequency of data back tracking that
resulted from incomplete or missing
54

data, to name a few. The resultant

picture showed a variety of tortuous
paths to resolving batch discrepancies, getting appropriate signoffs, and
being able to finally release the finished product for shipment.
But how did these project teams
determine what constituted a reasonable reduction for each project?
Measure (study): Few, if any, projects ever get approved without first
being able to quantitatively illustrate the current state and what
would be a reasonable amount of expected improvement.
Clients explained the problems
differently and frequently used different terminology, but each agreed
the goal was to reduce the time required to release a finished product
to shipment. (For this article we are
using an average of multiple projects thus the 10% value.)
Using the time-date stamps logged
on the mass of paperwork for 100 or
so batch-records the client/consultant
teams determined that the average
time required to release a finished
product for shipment was about 60
to 80 days. The teams then developed
cause-and-effect (Fishbone) diagrams
to illustrate the contributing events
which included:
Missing and ambiguous entries

Chemical Engineering www.che.com March 2007

Incorrect entries and entries in the

wrong place
Clarifications required, such as illegible handwriting and crossed out
entries
Calculation and rounding errors
Deviations outside defined control
limits
Miscellaneous questions
The next step was to convert events
into numbers. For this step, the teams
developed Value Stream Mapping
(VSM) diagrams to show how long it
would take to release a product for
shipment if all the required information was available and accurate the
first time. When placed along side
VSM diagrams illustrating various
delaying event scenarios, the potential
for improvement became obvious. But
was it as good as it could be?
Benchmarking is a widely accepted means of learning how the
activities of one company compare
to those of other companies performing similar ones. Benchmarking within an industry provides
comparisons among like companies, but even the best within an
industry might not be the best
when evaluated across industries.
A 2004 survey [4] revealed that
most pharmaceutical companies
achieve about 85 to 95% (2.5 to 3.1s)

evelop or work with a partner to implement an OpX

improvement program for your life-sciences or other
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manufacturing. If working with a partner, insist on recognized industry expertise and a proven track record of accomplishment.
An OpX Improvement Program (Figure 2) should begin with
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an initial assessment, which typically takes two to three days.
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Partners in this process can assist with defining areas of opportunity for throughput improvement, cost reduction, and
increased availability. When the initial assessment is completed, the findings should be presented to plant manage3FQPSU
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ment and subsequently incorporated into a written report. SFDPNNFOEBUJPO
The report should include:
Details of the findings with associated potential improvements that can result in high-level, definable benefits
Proposed next steps, which may include a more detailed
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and focused study, are also included in the report
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Broadly quantified benefits that have been linked to available business level information
An outline of how the team can assist to capture the identi3FTVMUT
fied opportunities
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Initial assessment success is driven by three key items: appropriate time carved out for key plant personnels involvement;
access to relevant operational information; and a client representative who can facilitate obtaining answers and/or schedule interviews and who also reviews and comment on report drafts. Without commitment
to these key elements, the quality of the assessment can be significantly diminished.
Often the initial assessment reveals associated and/or enabler projects. Assessing and
developing these projects is completed during a detailed study. The duration of a detailed study is normally dependent on the findings in the initial assessment.

right-the-first-time (RFT) to quality review with the best companies

achieving RFT to quality review were
at about 96% (3.3).
On average, the case history facilities were experiencing about 19,500
defects per one million opportunities
or 3.6. In other words, these clients
are as good as the best, at least when
compared to their peer companies.
However, the survey also provided
results indicating that world-class
manufacturing and processing facilities across multiple industries were
achieving a 99.4% (4.0) RFT to quality review, which equates to only 6,000
defects per million opportunities far
better than the composite case histories. Thus, a 10% improvement target
was a conservative improvement goal.
The point is, Wall Street analysts
might throw your company a couple of kudos for being among the
best of your peers or within your
industry segment, but achieving
operational excellence is not just
about beating your competition, it

is about being among the best of

the best across all industries.

Wrapping up

In the example, the client/consultant

teams went on to develop improvement roadmaps illustrating two scenarios. The first scenario illustrated
what the teams recommended as
a temporary state, with improvements in procedures and practices
that would provide near immediate
financial benefits while building a
foundation for a future semi- and/or
fully-automated solution. The final
scenario revealed a paperless futurestate with document management
software ensuring that information
critical to releasing the product to
shipment was accurate and complete
as it was being developed.
Besides cost calculations, justifiable
savings calculations were also developed for these scenarios. The results
are summarized in Tables 1 and 2.
As often happens with such projects, savings claims are some-

References
1. Jack Welch, Key Annual Speech to Shareholders, 1981 (http://callcentres.com.au/
GE5_Jack_Welch.htm).
2. Covey, Stephen R., Principle-Centered
Leadership and The 7 Habits of Highly
Effective People, Simon and Schuster, Inc.,
N.Y. 1992.

3. Breyfogle III, Forrest W., Implementing Six

Sigma, Wiley Interscience, N.Y., 2003.
4. Benson, Roger, McCabe, Jim, "From Good
Manufacturing Practice to Good Manufacturing Performance," Pharmaceutical Engineering, July/August 2004.

times reduced or denied, but even

after some give-and-take, the total
savings of the future state remained compelling enough that in
each case executive management
approved various investments in
multi-year projects.

Get started

Operational Excellence (OpX) is more

than setting a goal of conducting business in a manner that improves
operational efficiency. Its even
more than improving quality,
obtaining higher yields, faster
throughput, and less waste. It is
about achieving a state of corporate performance that Wall Street
analysts acknowledge, admire, and reward. OpX is about being the best of
the best.
Achieving a state of operational
excellence requires using the
right tools, methods, and advice
combined with unwavering commitment, patience, constant encouragement, trust, celebration
of success, objective reviews of
misses, and the flexibility to accept that just because something
worked (or did not work) in one
location is not a guarantee that it
will produce similar results in all
similar locations.
So, are shareholders, Wall Street
analysts, and financial institutions
showering accolades and praise
upon your company? If not, show no
fear and begin the operational excellence commitment right in the heart
of your organization, right where a
lot of the money is spent and made
production.

Edited by Gerald Ondrey

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Start an OpX Improvement Program

Author
Michalle Adkins is an
OpX Consultant at Emerson
Process Management (103
Enterprise Dr., Royersford,
Pa. 19468. Phone: 610-5694005; Fax: 610-569-4001;
Email: [email protected]) She has
over 15 years of industry
and consulting experience
in the areas of operational
excellence consulting, project management, production planning, vaccine
manufacturing, automation, computer validation and engineering. In her role at Emerson
Process Management, she has consulted with
major pharmaceutical companies on projects
that have included MES solution justification,
OpX opportunities and system life planning.
Prior to joing Emerson, she was with Merck &
Co., Inc. for 13 years. Adkins has a B.S. Ch.E.
and an M.E. in industrial engineering.

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