While other industry sectors have adopted prepackaged improvement programs since the 1980s, it is only in the past decade
that the biopharmaceutical industry has witnessed the rise to prominence of the three-letter acronym (TLA)-based improvement
initiative. Business process management (BPM) and human error reduction (HER) are currently in vogue. While much has been
promised by these prescribed solutions to improve business performance, much of this promise has proved illusory. Even where
measurable improvement has been achieved, it has not always shown where it matters in overall operational performance and
on the bottom line.
The truth is that while most of these approaches do have intrinsic value, unless the approaches are rigorously adapted to
the situation of the business and the needs of strategy, the results are unlikely to be what is required. Many managers intuitively
know from their own experience that just improving things without a clear link to strategy will not necessarily produce better
business results. In some companies, the problem has been exacerbated by changes in priorities and direction caused by the
switch from one TLA to another, as disillusion with the previous approach has set in. A few unfortunate organizations have
nearly drowned in the resulting alphabet soup.
Change needs to be focused on delivering the business strategy. It is through realizing the strategy that the company gains
competitive edge, and it is this that delivers the bottom line. Moreover, for the biopharmaceutical industry, GMP compliance
needs to be up front and center along with productivity and service.
Many improvement programs do not derive their change agenda directly from the business strategy but come complete with their
own. Too often, this leads to change being driven by the dictates of the approach, not by the needs of the business. Things
frequently end up being done because the selected approach says "it's a good thing" and not because improving the way a particular
task is done is essential for the company to deliver its strategy. As a result, precious resources can be diverted away from
the important things.
There are no simple solutions or short cuts to improved business performance, but there are some fundamentals upon which a
pragmatic, strategy-directed change program can be built.
- Provide the organization with leadership.
- Clearly communicate the values and guiding principles that underpin the strategy and make them real in the form of the appropriate
behaviors, policies, performance measures, and reward and recognition systems.
- Concentrate on bringing people along and gaining their commitment to the actions that have strategic significance.
- Make sure the basics are in place before becoming more ambitious. It is important to build sound processes, habits, and capabilities
into the business to avoid the risk of building on sand.
- Direct the improvement where it gives maximum impact in delivering the business strategy by targeting the actions that are
key to achieving operational excellence and GMP compliance.
- Make sure that the organization is capable of handling the load being placed upon it. Over-stretching an organization disproportionately
reduces effectiveness and generally results in nothing getting done properly.
- Invest in training and development to raise the overall capability of the business and particularly those capabilities that
support the core competencies.
- Assess each technique, theory, and approach rationally in terms of problems it can solve. After careful consideration, discard
what is not useful and adapt what remains to suit the needs of the situation.
- Test and refine solutions through experimentation and be prepared to learn from minor mistakes.
- Never lose sight of what you are trying to achieve.
To perform over the long term, the winners will be those companies that can most effectively deliver their strategies. Any
change initiative that is not directed by the requirements of the strategy and tailored to the needs of the business is unlikely
to succeed because it will lack true relevance. It is only by creating a clear link with strategy and following through with
a pragmatic approach to implementation that a company makes the best of its strategy and thereby gives itself the best chance
Simon Chalk is director of the BioPhorum Operations Group, email@example.com