applying a specific set of technical guidelines and principles
for designing flow.
PRODUCT FAMILIES AND PROCESS FAMILIES
While the concepts of product families and process families are not new, the application of them to create flow is.
Product families are a group of products that go through
similar processing steps and have similar work content.
They are created from the point where an organization can
dedicate equipment downstream to the customer. Process
families are groups of products that go through similar upstream, or shared, equipment. These are formed in the upstream, or shared, equipment area of the operation.
The logic behind creating product families is to group
parts together according to shared similarities in the way
they are made, not shared similarities in the way they are
sold, marketed, catalogued, or utilized by end customers. If
the process content and total work times are too similar to
yield any meaningful groupings, parts can be organized by
changeover time, perhaps, grouping them together so they
are processed at each machine in such a way as to minimize
changeover times between “changeover families.”
Process families are designed to dedicate a group of up-
stream processes that serve many downstream processes
by “locking” certain products to a certain group of ma-
chines, even though they will flow to different areas once
completed. The benefit of these families comes from stan-
dardizing setup, cleaning, and sterilization methods used,
and always knowing which product will be made on which
group of machines, even when the equipment is shared.
Once product families and process families are created,
the next step is follow eight guidelines to create end-to-end
flow through the operation. The first guideline is a variant
on takt called takt capability. Normally, takt tells the rate
at which an operation needs to produce in order to meet
customer demand, e.g., 500 pieces per hour. Sometimes,
however, customer demand can be erratic, hard to know or
predict, or even truly variable.
In those situations, takt capability tells how much an operation is able to produce over a given time period in terms
of both volume and mix. The incorporation of product mix
Operational Excellence has often been ambigu- ously defined: “excellence in everything we do,” “world-class operations,” or “the best of the best.” However, there is a practical, hands-on
definition of Operational Excellence that, when achieved,
can enable operations to run without management and
enable company leadership to spend its time on streamlining product development, researching new markets, working
with customers on their needs, and other activities focused
on business growth.
That definition of Operational Excellence is when, “Each
and every employee can see the flow of value to the customer, and fix that flow before it breaks down.”SM Reaching
this state creates a “self-healing” flow of products to the
customer where employees who build the products know
whether the flow is normal or abnormal, and know how to
fix abnormalities in the flow without the need for management intervention.
While this process may sound simple and straightforward,
when organizations try to apply these concepts to real-life
pharmaceutical environments, it can get complex quickly.
Difficult questions often arise, such as: How do we handle
processes or machines that are shared across different
product lines? What do we do when many, or perhaps even
all, of our parts pass through every process in the operation? How do we create a “self-healing” flow if we process in
batch and have long changeover times?
The answers to these questions lie in an organization’s approach to continuous improvement. Instead of management
setting goals, forming teams, and running Kaizen (rapid
improvement) events, the key is to set a destination of
Operational Excellence (previously defined) and reach it by
■ By Kevin Duggan, Duggan Associates
How you approach continuous improvement is key to success
■ 36 NOV/DEC 2013 | PHARMACEUTICAL PROCESSING
■ PHARMPRO. COM
Production Capability - 400 Per Day
Product Description Weekly Demand
A Plastic Arm 1000
B Steel Arm 600
C Aluminum Arm 300
V Titamium Arm 100