Real Lean Transformation

Solid Dose (Small Molecule) Pharmaceuticals.

Client Environment

Solid Dose (Small Molecule) Pharmaceuticals.

 

Geography

Multi-site Lean Quality Assurance (QA) Program in North America.

 

Objectives

The primary objective of this project was to reduce batch record review and disposition times to facilitate accelerated release of product to market. Ancillary objectives included increasing QA team productivity through implementation of capacity planning and standard work and streamlining of deviation management processes.

 

Solutions Deployed

  • At a Regional level: A standardized approach for managing batch review and disposition workloads including capacity planning and monitoring of key performance indicators.
  • At a Site level: Levelling, flow and standard work solutions tailored to the site-specific targets. Implementation of effective visual management systems that optimized daily internal processes and customer delivery. Design and implementation of a digital visual management solution for site-wide deviation management.

 

BSM Case Study - Solid Dose (Small Molecule) Pharmaceuticals

 

Results

  • Reduction of batch record cycle time from an average of 12 days to 48 hours or less.
  • Self-directed work teams capable of overcoming transient workload peaks through capacity resource modelling, ultimately ensuring robust supply chain delivery.
  • Increased visibility and oversight of deviations with concomitant rapid escalation and resolution through the implementation of a digital visual management system.