Improvement Tools for the early 21st Century in Pharmaceutical Operations – Operational Excellence by Jim McKiernan and Jim Curry

Improvement Tools for the early 21st Century in Pharmaceutical Operations –
Operational Excellence
by Jim McKiernan and Jim Curry
An important part of the Operations Management Community of Practice (COP) will be
to help members understand and share experiences in the use of appropriate
improvement tools to ensure that technical operations continuously improve and
achieve best in class levels of performance. As we all know, the industry is under
unprecedented pressure to deliver innovative health benefits at affordable costs. This
means that Operations Management is also challenged to maximize the strategic
benefit it provides to the company at an acceptable level of cost. As a key driver to
delivering on this challenge, the industry has been adopting practices long since
common in other industries and which may be understood as coming under the
umbrella term of “Operational Excellence.” Tools included in the Operational Excellence
“toolbox” include Lean, Six Sigma, Continuous Improvement (Kaizen), Risk
Management, and Design for Manufacturing.
Current Status
The pioneering pharmaceutical companies in this area mostly started their Operational
Excellence journey in the mid- to late-‘90s and there has been a huge uptake during the
past ten years. From our perspective, companies are at one of three stages of maturity
in implementing these practices:
Advanced – actively seeking ways to break traditional pharmaceutical paradigms,
challenging long-accepted SOPs and internally generated barriers to change.
These companies are looking to industries such as automotive, petrochemicals,
aerospace, electronics and consumer goods for ways in which to reconfigure
manufacturing practices and supply chain configurations.
Intermediate – these companies have been on the journey for about 5 years and
are beginning to realize improvements in production change-over times,
throughput times as well as the relevance of new performance metrics such as
OEE (Overall Equipment Effectiveness).
Beginners – these have just started within the past 2 years and are keen to learn
from their peer companies in the Intermediate and Advanced stages in order to
speed up their implementation and make up for lost time.
Next Steps
The Operations Management COP Improvement Tools Working Group will be focusing
on ways in which information and experience exchanges can take place. We will also be
organizing sessions at future ISPE meetings in which Operational Excellence best
practices can be shared. In our next E-Letter we will explore the meaning of OEE and
how it is being applied in pharmaceutical companies today.