Bio-Serv

bioserve 
LEAN and Kaizen Techniques for a boutique contract manfacturer.

Bioserv Corporation (Bioserv) is a leading boutique contract manufacturing service provider with over 35,000 square feet of facilities whose core competencies are centered in aseptic and non-aseptic bulk formulation, filling, and finished goods assembly, kitting, and packaging as well as controlled temperature storage and distribution services to support Pre-Clinical, Phase I and II clinical trials. Bioserv has committed to their clients to take responsibility to meet those needs and to measure our success against all applicable regulations and standards as part of our dedication to maintain the effectiveness of their Quality Management System.
 
The acquisition by KESA Partners and the addition of key members of the executive management team has positioned Bioserv for growth in the Phase III and commercial production of drug products. As part of this expansion, the management team asked for a GDP readiness assessment of packaging, storage, and distribution activities. As part of that commitment, the management team engaged Modality Solutions to assess and implement inventory controls and train Bioserv personnel to be Lean Practitioners.

OBJECTIVES
The results of the readiness assessment presented several opportunities for improvement. Several of the critical and major findings of the GDP readiness assessment were addressed during the course of the engagement:
  • Visual control techniques
  • Procedures to match actual practices 
  • Implementation of a inventory control system
MEASURES OF SUCCESS
Progress toward the objectives were measured by:
  • Completion of lean assessment designed to identify opportunities for waste elimination and improved process flow in warehouse operations.
  • Completion of a minimum six (6) Kaizen projects with the objective of simplifying and improving operation of the warehousing and distribution process.
  • Technical transfer of lean skills required to implement Kaizen projects independently.
VALUE TO BIOSERV
The value of this project was multifold, including:
  • Access to experience in preparing operations in highly-regulated distribution environments for audits from multiple jurisdictions (e.g. FDA, EMEA, etc.)
  • Apply lean techniques to optimize current distribution processes with minimum investment.
  • Learning opportunity across organization to better understand current best practices in applying lean tools to controlled-environment logistics process improvements for GDP operations.
METHODOLOGY
The assistance that we provided to Bioserv follow:
  1.  Complete lean assessment designed to identify opportunities for waste elimination and improvement in process flow.The lean assessment included value stream mapping of the distribution and storage processes focused on inventory control.  Analysis of the value stream map provides insight into where improvements are needed in process flow to improve control and accuracy, reduce waste, and automate transactions in the current accounting software (BusinessWorks by Sage). 
  2. Conduct Lean and Kaizen techniques seminars. Half-day seminars on Lean and Kaizen techniques were conducted for the Bioserv personnel. This seminar was an introduction to Lean and Kaizen designed to prepare the team for the six (6) Modality Solutions-led Kaizen events to reinforce learning and practice tools. 
  3. Conduct six kaizen events to apply lean techniques to warehouse and distribution. A kaizen event is a two to three day focused work effort to make significant improvements in operations.  The events used different lean tools and techniques designed to address critical warehouse operational issues. The focus on the Kaizen events were:
    • Inventory control process maps
    • Visual and procedural controls in warehouse operations and inventory control
    • Cycle counting and electronic transactions in accounting software