Paradigm Shift: Changing the Process and myself

As young man I did National Service (compulsory military training) before going to university and then gaining a graduate apprenticeship, working for an excellent firm in the plastics industry during the sixties.

The industry was then advancing rapidly with many projects and opportunities. Computers were being used to design and control plastics manufacturing processes for the first time. New polymers were being discovered, for which processes had to be designed, too. It was an exciting time to be a chemical engineer.

After a decade in this high-tech environment, an opportunity for promotion and change arose. A senior appointment in a chemical engineering group with a foothold in the pharmaceutical industry was advertised. The job was to extend chemical engineering into the formulation processes. I accepted the job offer.

Undergoing and initiating change is never easy. The high-tech, large scale, plastics industry involved batch and continuous processes with the aim of optimizing these processes to add as much value as possible. This was an ideal environment for a creative engineer. The pharmaceutical industry was completely different, particularly the formulation processes. These were all small-scale batch processes. Very high-quality standards took precedence over process optimization. Pharmaceuticals generated larger added value than plastics, too.

Process development and management was performed by pharmacists and chemists. The pharmaceutical products were strictly regulated by the Medical and Healthcare products Regulation Agency (MHRA). Once a product was commercialized it was produced to Good Manufacturing Practice (GMP) rules contained in ‘The Orange Guide’ published by the MHRA. The concept of Quality Assurance (QA) was a basic requirement for every process and defined strict Quality Control (QC) of production. Once a pharmaceutical product was commercialized it was virtually impossible to change the production process due to legislation. This system was utterly different in almost all respects from that of the plastics industry!

I found that formulation development was performed exclusively by pharmacists who largely controlled process development, too. My arrival (and that of others) as a chemical engineer in this environment was thus a threat to a well-established system. There was strong resistance to change. Nevertheless, as a newcomer I was astonished at the antiquity of some of the processes and the need to improve safety aspects such as dust control. I endured a very stressful period that took years to overcome. Luckily, I found friendships and opportunities that enabled me to introduce new process ideas that eventually proved practical and successful. Chemical engineering became a key resource of the system.

Although educated as chemical engineer to think holistically, I was slow to understand the importance of the beliefs, ethics and practices of the people working in the system. Adaptive human activity systems such as the one that I encountered are the hardest to understand, too. This was a crucial learning event for me. The principle, which led to further successes over the next decades, is described as follows.

The most important asset of a chemical engineer is the ability to think holistically. ‘Systems Thinking’ helps to understand and, sometimes, resolve industrial problems encountered. This article illustrates how identifying the system paradigms is important. Paradigm, or community mind-set is the underlying belief that workers in the system adopt to work and live successfully and must be identified clearly to make a change effectively.