Six Sigma Case Study in a Biotech company

Problem: A Canadian Biotech company had too many samples for testing in their research lab. How to cut down this analysis load?

Due Diligence:  The entire product development process was mapped end-to-end. Possible causes for the problem were identified using RCA. It was found that, there were way too many experiments conducted during product development. For e.g. 85 experiments were conducted to arrive at a base level prototype having minimal features.
 
Solution: Six Sigma methodology was employed. More of experiment planning was needed during product development. Regardless of type of product or product complexities, the aim was to keep experiments to minimal. Design Thinking and DOE were employed. The development protocol was modified such that final prototype is developed with meager 20 experiments at the maximum. Alongside cutting down analysis load, the process improvement campaign cu down product development time, built-in product quality, and enhanced production output.

Result Dashboard: 

• Decreased overall development costs by 200 %
• Improved R&D’s productivity by 250 %
• Prevented recruitment of additional scientific manpower, thereby curtailing business    expenses and overheads.

​Lean Kaizen Case study

Problem: A Canadian Pharmaceutical company had production issues with fifteen products and this consequently increased production back-orders. How to improve operational efficiency?

Due Diligence:  Conducted a value stream map to identify potential cause(s) for the back order situation. Additionally technical processes of production were also evaluated. Both technical processes as well as operational processes had snags and must be improved.

Solution: Lean Kaizen methodology was employed. Pharma being a regulated industry, the regulatory impact of proposed process change must be studied prior to embarking on process improvement journey. Regulatory impacts studied were- statutory compliance, licenses, tax breaks, sales permission etc. A protocol for process improvement for all 15 products in a tiered fashion was designed. Appropriate modifications to production planning and concerned operational processes were undertaken.

Result Dashboard:

• Process improvements for all 15 products was completed within time-scope-budget.
• Process improvements of 8 products were done without need for statutory re-approvals.
• Back order status was reversed; market demands are being met timely.
• Process improvements for balance 7 products were done without need for beta testing/ bio-equivalence studies.
• Overall saved around 15% of total budgeted expenses for this project basket.