Research in the Pharmaceuticals Manufacturing sector

We carried out observational work in two companies, both UK sites of multinational companies. Our research has focussed on manufacturing rather than research and development activity, since it is in the former that there is the greater proportion of intermediate-level employees.

In support of our research, we have had productive contacts with SEMTA, the sector skills council with partial responsibilty for this sector, and also with the Association of the British Pharmaceutical Industry, the employer representative body for the sector.

One company was a UK manufacturing and packaging site of a large multinational "ethical" company. The other was a generic company, the UK packaging-only site of a multinational manufacturer. In the first company we carried out observations of tablet-making (i.e. the blending of active drugs with inert materials, which are then formed into tablets) and packaging, with two supervisory managers observed and interviewed in each area. Managers of the two areas were also interviewed, as well as the human resources manager. We also attended a “statistical process control” training course.

In the second company, we carried out observations with supervisors and machine operators, and interviews with managers. The company had recently implemented a data collection and analysis computer system, and was facing the question of how to educate its machine operators and supervisors in using this system to carry out process improvement work.

Both companies were heavily engaged in process improvement activities, which we take to be typical of the sector as a whole. Indeed, we had discussions with more than 10 companies to try to get research access, most of which said they could not help us due to large-scale reorganisations and training developments based on increasing process productivity. The first company had an extensive "lean Sigma" process improvement programme in progress (including SPC), and the second was exploring the use of techniques of Total Productive Maintenance, including the performance measure known as Overall Equipment Effectiveness (OEE).

We suggest that the introduction of these major process improvement programmes impacts significantly on TmL requirements, since they necessarily involve a degree of analysis and interpretation of the manufacturing processes among employees (operators, team leaders, supervisory managers) who traditionally have probably been instructed to follow procedures and leave interpretation to others (engineers or technical support staff). The overriding issue that we identified is how to reconcile the heavily-regulated nature of pharmaceuticals working practice, which has a tendency to disempower individual workers, with the more self-motivated and self- regulated practice that is typical of process improvement initiatives?

Learning opportunities for this sector

We have not been able to carry on relationships with companies in order to develop any learning opportunities for this sector, around process improvement. This lack of progress prompted us to pursue connections in another sector, Automotive manufacturing, for which we developed tools aimed at concepts in statistical process control.

These tools have been created in a generic form and would be suitable for use in pharmaceuticals companies. See the following link for information:

Statistical Process Control

Publications about this sector

Hoyles, C., Bakker, A., Kent, P., & Noss, R. (in press). “Attributing meanings to representations of data: The case of statistical process control”. To appear in Mathematical Thinking and Learning.