Medical manufacturing output and quality improvements result in increased capacity
Although progress had been made since the move to the new facility, there are a number of areas for improvement around the business’s Quality Management System and the implementation of the processes contained within it.
The business recognised it required a holistic programme to address the systemic issues and behaviours linked to a prevailing culture of accepting production deviations as the norm and not addressing the root cause.
Bourton Group were asked to review the operations to provide a route map to increase efficiency, allowing an increase in capacity to support the business strategy for worldwide sales growth
Bourton Group assessed the production facility and through a combination of work study methods, process mapping, data collection and detailed analysis, quickly identified opportunities to increase output through improved quality.
We conducted a series of focused Lean workshops which identified several quality improvement opportunities.
Phase 1 of the assignment included a data collection exercise to establish focus areas for scrap reduction. Graphical analysis of the data showed scrap due to particle contamination on the 10ml Ampoule product was highest at 31% and constant adjustments were being made to the auto inspection process during production runs. This led the team to conduct measurement systems analysis to assess the capability of the inspection system which showed the system to be inconsistent during operation resulting in good product being rejected.
With the help of Torbay Pharmaceutical Engineers the measurement system was improved to give a more effective auto inspection process which resulted in the reduction of falsely rejected product.
Once confidence was gained in the measurement team we then undertook data analysis using DOE (Design of Experiment) techniques to determine the optimal machine settings to further reduce scrap levels. Phase 2 focusses on transferring the benefits to other Ampoule products whilst also addressing the different failure modes identified in Phase 1 which will result in further quality improvement and associated savings.
Phase 1 – 10ml Ampoules Line Project reduced scrap rate due to particle contamination from 31% to 5% with only 8 days Bourton support resulting in estimated cost saving in scrapped units of £80k/year
If similar projects were completed across 1ml, 2ml and 5ml Ampoules product additional cost benefits of over £100k could be achieved.
Scrap levels on other products is estimated at approx. 26% (74% yield). If similar levels of improvement could be achieved on non-Ampoule products further significant scrap saving could be achieved
The team are expecting to see a return on investment of 5:1 through product quality improvements alone.