The Roadblocks Are Significant
 Figure 2. Most frequent challenges in the implementation of operational excellence programs
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Several participants admitted difficulties in making significant and lasting change without a "big bang" approach. Figure
2 shows the breakdown of where the challenges have been in driving the program forward. The lack of resources and middle management
resistance top the list.
WHAT IS THE PATH FORWARD?
A few things must change for the majority of the existing programs to make more significant progress. Although the survey
shows that senior management buy in has been achieved, it is not clear whether senior managers are demonstrating the required
behaviors (and willing to make the difficult decisions) to make the program successful. Their involvement is critical to fill
the gaps identified above—middle management commitment and lack of resources. Management needs to continuously articulate
the need for change and prioritize the work of the organization by aligning it with the strategy, removing obstacles, and
being adamant (although supportive) with their direct reports in following the objectives of the programs.
An additional challenge may come from the focus of the programs themselves. Are the projects being executed in alignment with
the priorities and the business goals of the organization? Without specific, quantified objectives, and a clear definition
of accountabilities (with consequences), these programs will always have a difficult time garnering the necessary support
to make a significant impact. Many companies are discussing how these tools and techniques can apply in R&D, with a focus
on driving faster (or more productive) product discovery and development.
At the end of the meeting, many participants expressed that driving operations excellence programs in biopharmaceutical organizations
will take truly visionary leadership. The pressures that have led to successful Lean transformations in other industries or
traditional pharmaceuticals aren't yet there in biopharmaceutical companies.
Biopharmaceuticals that have been most successful have had leaders who see the winds of change coming quickly and view operations
excellence projects as something essential for running a successful organization. But like most things, it comes down to people.
Marc Puich is a partner at Tefen, Ltd., Foster City, CA, 650.357.1120 x117, marc@tefen.com
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