When it comes to manufacturing, there are six big losses:
- Breakdowns
- Setup and adjustment
- Idling and minor stoppage
- Speed
- Quality defects and rework
- Startup/yield losses
Total productive maintenance (TPM) aims to eliminate all these losses—completely, to maximize overall equipment effectiveness (OEE). Through a phased approach, businesses begin to identify weak production equipment, bring them up to a baseline, engage teams across the business and start a planned maintenance program.
TPM is a concept that is used to optimize production across several industries, including the automotive and process industries, and is now emerging in pharmaceuticals.
I spoke with Duncan Cole, Project Manager at Wolters Kluwer Enablon, about the singular impact that these losses can have on the pharmaceutical production process and the end product. Duncan spent nearly 20 years in product manufacturing and operations at Novartis.
Can you describe an example of a big loss that you encountered on the production line?
Duncan: We had an issue years ago. Some seal fluid leaked into the product. Even though it wouldn’t impact a person, because this product wasn’t directly going into a tablet and the seal fluid was classed as fit for human consumption, we still needed to plan a way to remove the seal fluid contamination. This is known as “re-working” the batch, basically cleaning it of the contamination to an acceptable level.
The problem being at this point, the team couldn’t actually do anything to clean/re-work the batches, and this was basically because of the complicated nature of the re-work process meaning it was counterproductive to actually try to do this and would in fact cost more without the guarantee of success.
Because of this loss, what impact did this have on the business?
Duncan: There was a huge impact to us as the batches needed to be incinerated and also the plant cleaned of any remaining contamination.
The business came up with an impressive analogy for this. We all got a message to go watch a video. They showed a Ferrari being crushed and said we had basically just bought a Ferrari and crushed it. That was the impact.
The product would, at a later date, have been used in the production of an anti-epileptic drug. We were basically many, many kilos down on this product because of one mistake related to permitting and monitoring of production alarms meaning any production and maintenance activities had not been carried out effectively.
