Articles and Reports

Performance metrics are a critical part of any effective Lean Lab solution, helping to identify issues and directing and driving performance improvements.

As part of every BSM Lean Lab or Lean R&D project, metrics are developed with these concepts in mind. This briefing will describe our Lean Lab approach to performance metrics, demonstrate specific examples and highlight the applications of the approach to include visual displays, reduction of metric data gathering workload and applicability to the FDA’s guidance on metrics to facilitate risk based assessments.

In laboratories a significant cost is often incurred due to a mismatch between workload demand and actual capacity.

BSM’s structured approach to Capacity Planning addresses and consistently alleviates this mismatch, ensuring efficient and productive management of laboratory resources.

This report examines Lean in the Regulatory Affairs environment. It looks at the typical issues that arise in Regulatory Affairs Organisations and the benefits achieved through the application of lean principles.

In pharmaceutical companies, the Quality Assurance (QA) function is usually directly on the critical path for the release of product and is often a significant cost center in its own right. QA functions are complex areas with volatile, short interval workloads and often suffer from poor or inconsistent performance.

In this paper, we describe applying Real Lean to free up capacity, increase quality and accelerate time to project & program completion.

This Report examines Lean in the Laboratory. It looks at the typical issues that arise in Labs and how to Apply Lean in the Laboratory - Key Principles that always apply.

This article presents a case study based on an international workshop hosted by Novartis Vaccines to prepare guidelines for incorporating lean principles into pharmaceutical quality control laboratory design.

The design, layout and placement of Laboratories have a significant impact on lab processes, behaviors and communications. A ‘good’ design will proactively support lean processes including, flow, visual management, standard work and excellence in workplace organization whereas a ‘bad’ design may actually create waste and make flow more difficult.

This briefing addresses the issues and problems often associated with manual Batch Records, including long review and approval lead-times and poor ‘first time’ document accuracy.