Kaizen Case Study

Problem: A Canadian pharmaceutical company wanted to develop products for US markets (ANDA para III and IV) in their pilot manufacturing site. What changes/ upgrades may be needed? Can this be done ?

Due Diligence:  Yes, provided the pilot manufacturing plant is a part of commercial manufacturing facility and not R&D. The pilot manufacturing must have manufacturing permission of small batch sizes other than for ‘clinical trial use’. A facility audit was conducted along with USFDA regulations impact analysis.

Post assessment it was found that, the pilot manufacturing site was in compliance to US FDA norms with respect to engineering requirements for the facility.

Solution: Kaizen methodology was employed. Minor facility upgrade, major improvement in training, operating procedures, documentation and records was recommended; and successfully implemented.

Result Dashboard:

• Facility passed US FDA audit in the very first inspection.

Note: The product development strategy is very important. Product made 'glocal’ i.e. global appeal with local compliance, exhibit very little issues while expanding to newer markets. Also, it is advisable to produce at least one stability batch in pilot plant. Data from such a batch assumes great significance while discussing with FDA office.

​Business Process Improvement and Training Case Study in a Biotech company

Problem:   Acquisition of a company and improving  business processes post asset mergers. A Canadian Biotech company was in talks to acquire a sick company and wanted to evaluate merit of such an acquisition. In case the acquisition went through, then re-organization of the product portfolio would also be necessary.

Due Diligence:  Due diligence of the sick company’s records, sites, R&D pipeline , patents, regulatory status, machinery, product portfolio, product stability trends etc. were conducted. Audit report, recommendations and execution strategies were forwarded to the sponsor company. Employees from parent and acquired organizations needed training to make working flow smooth and productive.

Solution: A core team was built, to carry out the steps proposed in my report.

Result Dashboard:

• Acquisition of the sick company was completed. And product portfolio post acquisition was strategically re-organized successfully.

​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.

​Kanban and Kaizen Case Study

Problem: A multi-national bio-pharma company wanted to do a manufacturing site change for 55 products within an aggressive time frame of 5 months? Can this be done ? How ?

Due Diligence:  A due diligence of proposed manufacturing site was done and gap analysis report was documented. The due diligence report, gap- block strategy recommendations as well as budget estimations were provided to the organization’s executive management team; to facilitate Go/Kill decisions.

Solution: Kanban and Kaizen methodologies were employed. Product wise site-transfer protocols were developed (especially taking into consideration the different product/ process complexities and challenges (both known and anticipated), production capability and market demands. A product wise ‘Risk Assessment and Mitigation’ protocol was developed.

Result Dashboard:

• All 55 products were transferred to new site as planned and within time & cost budget.

Note: The product development strategy is very important. Product made ‘glocal’ i.e. global appeal with local compliance and developed using QbD, exhibit very little issues while expanding to newer manufacturing sites.

​Launching and growing a Startup R&D unit Case Study

Problem: A SE Asian bio-pharma company that sold white labeled products wanted to start indigenous research facility. They also wanted to improve product quality and logistics as most of their products had customer complaints.

Due Diligence:  Due diligence of their product mix, complaints, new product portfolio was done. Value stream maps for all existing products were set up. A site for the start-up R&D was identified.

Solution: Design Thinking and Hoshin were installed to create R&D infrastructure and build capabilities to meet company’s goals.

Business processes dealing with recruitment, employee engagement, material/ machine procurement, compliance and general QMS, IPM, regulatory, product development, distribution and logistics were re-engineered.  Kaizen was installed across the organization to maintain culture of quality and continuous improvement.

International marketing business processes were also set up enroute as the company added ‘exports to Netherlands, CIS, GCC and ASEAN countries’ to its corporate goals. Hence, course-correction was done appropriately, successfully.

Results Dashboard:  

• The organization succeeded in internalizing R&D to the tune of 95 % in the very first year.    
• All product quality complaints were addressed and successfully closed.
• Profits grew exponentially. The company which was at 68th rank on National ORG list got on to 28th position in just 3 years !

​Innovation Management and Business Turnaround Case Study.

Problem:  A Global Contract Research Organization (CRO) was sick and on the verge of being sold out. The management wanted to give a final shot for its revival prior to potential sell off.

All projects were running late. Not a single project milestone was achieved hence, clients had stopped payment. Company’s cash-flow had come to standstill. Many employees were laid off. As the company had no funds to pay vendors, they had stopped supplying raw materials, hence work stopped too. It was turning into a vicious catch 22 situation. No funds- so no project work was happening and clients paid no funds- because no project milestone was delivered.

Due Diligence: Financial and Technical Audits, RCA, Pareto and Ishikawa studies were conducted to evaluate CRO’s financial health, site, systems, products, problems, processes, human capital, customer complaints etc. The objective was to review the CRO and bring back its glory.

Solution: Business process redesign/ re-engineering was undertaken alongside strategic portfolio management. Hoshin, QbD and DOE were installed for strategic innovation management. Lean and Just-in-time methodologies were installed to help cash-flow and prompt project deliveries. 8D and Kaizen models were executed to turnaround the business.

Result Dashboard:

• The CRO was reviewed in just 9 months! Balance sheet showed first signs of positive growth within 5 months of ‘process change’ implementation.
• An effective customer relationship management process was introduced which provided repeat business from existing clients.
• New clients were added. New contract research projects of over $ 35 million was received.