Case Study: Bio Pharma Lab

Case Studies

Bio Pharma Lab

Project	Lean Process and Business Performance Improvement Project to Improve Productivity of a Bio-Pharmaceutical Testing Laboratory
Objectives	To improve overall performance of the laboratory in terms of productivity, cost and profits through defining, managing and improving end to end processes designed for operating the entire business.
Unique Issues	This facility had been a small unit outside the mainstream of the major corporation’s Pre-Clinical Testing business.
Results	During and following this engagement this facility gained much recognition from the Corporate Offices for its increases in revenue and profit and its unique expertise and services. This operation had previously been a small operation and not considered as part of the core business for the Corporation. However, as a result of the successful implementation of the lean process based management system and increases in profitability: The Corporate Offices decided to keep the Bio-Pharmaceutical Testing Laboratory and to additionally expand this into more of this type of business. The corporation funded a major expansion of this facility increasing its capacity and providing state of the art testing laboratory resources. The General Manager was made head of a new business area for Biopharmaceutical Services worldwide with facilities in PA (USA), Scotland, two locations in Ireland, and two locations in Germany. In developing and implementing the Lean Management System the following accomplishments were recognized: Sixteen (16) major processes were diagramed. Sixty (60) procedures developed & trained along with installation and training of all employees on a document control system (insight 1’s OneWindow®). Twenty-two (22) process owners and their associated process participants were trained as well as eighteen (18) internal auditors. In the course of implementing the Lean Management System Insight 1, Inc. led the team in identifying improvement projects that contributed to the overall success of this operation. These included: Improvement for the Test Results Reporting Process improving on time delivery and reducing correction and reworks. Definition of an Improved Inventory Control and Management System Development and Implementation of a Corrective Action Database for tracking process Corrective Action Requests (CARs) Development and Implementation of a Training Data Base to assist in managing training of all personnel and maintaining their current training status. Developed and provided a Critical Materials Database as an interim means pending installation of a full inventory management system. Developed a new pricing basis and system for most frequent services for the lab. Developed new Master Scheduling algorithms based on and integrated with the tasks defined for standard pricing. Facility Re-Arrangement in support of increased throughput and revenues. Improved Operational Throughput for the Molecular Biology Laboratory increasing revenue for this product. Improved document control and increased standardization by reducing the number of Protocol Types and creating standard templates for the remaining standard protocols.
Description of Services	Defined and facilitated the development of a new Lean Operational Management System based on Lean Process Management methodologies. This led to identification and management of numerous projects for improving overall performance. During this engagement the operation recognized increased throughput, productivity, revenues and profits for the business. The tasks included the following: Facilitated definition of a hierarchical set of process diagrams for the Product and Service Life cycle for the business Facilitated definition of a hierarchical set of process diagrams for the management infrastructure. Defined Standard Operating Procedures for lower level processes making up the major processes. Facilitated the assignment of process owners for all processes. Trained Process Owners and authors in methodology for writing Standard Operating Procedures using the Insight 1, Inc. provided template. Facilitated and assisted the staff in developing, reviewing, approving and releasing 86 Standard Operating Procedures. Provided and installed the Insight 1, Inc. One Window® System for providing instant access of process management system documents. Trained an Internal Audit Team for conducting periodic audits of the process management system for verification of practice vs. documentation. Identified, managed and implemented numerous improvement projects.
Methodologies	Utilized Insight 1, Inc.’s unique lean methodologies for facilitation and documentation of hierarchical business processes. Also applied “Lean” techniques and principles in improving throughput and performance of numerous processes identified as detriments to overall performance of the lab.