My experience in industry and in the pharmaceutical industry specifically is that production throughput is often seen as being less important than or in conflict with compliance. This is a complete fallacy. One must stand back and look at the Business as a whole, and not at our individual departments. How can the business perform if we don’t deliver quality product in full and on time?
Compliant Productivity, is an environment where team members work together collaboratively to support the business and where visions are aligned to achieving a shared vision. Let’s analyse this:
- At all levels of the business, both personal and professional, a component of your vision must be related to the health and wellness of society. In short, this means we need to have the necessary specification compliant drugs available for patient use at all times.
- Another component needs to focus on the success of the business. If the business can’t deliver, it will fail with consequences for all. At the macro level, a shortage of drugs in the market place and at the micro level, job losses creating unemployment, more people dependent on the government and more pressure on those pharmaceutical companies out there trying to keep up with demand.
- A third component of your vision must include continuous improvement. Regulatory requirements are becoming more and more stringent every year so it is imperative that we are constantly reviewing and revising our processes. If we have a production related deviation, what process is in place to implement the solution signed off in the CAPA? Or, is the CAPA the end of the road?
- A fourth component of vision must focus on team learning. The world at large is moving faster and faster and is continuing to accelerate. The fourth industrial revolution is making certain of our processes redundant because they take too long to process. Two prime examples spring to mind:
- In our laboratories we have state of the art instrumentation carrying out analysis of products automatically, yet we carry out all the calculations of the final results manually.
- Another is the batch manufacturing documentation, we have invested R millions in manufacturing processes, but compile the documents manually.
Has anyone stopped to think of the unintended consequences of these 2 simple acts?
- Finally, vision must be converted into designed objectives and action plans, with specific measures for all players that keep the focus on the overall business goals.