Real Lean Transformation

Articles and Reports

Metrics Methdology

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 athering workload and applicability to the FDA’s guidance on metrics to facilitate risk based assessments.

Capacity Planning in Laboratories

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.

Lab Excellence in R&D

R&D labs are significantly different from other types of laboratory, and indeed from each other. Different approaches are required to the implementation of standard lean elements. In this briefing we give an overview of the common improvement opportunities in R&D and the solutions that apply in different laboratory types.

Real Lean in Quality Assurance Report

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.

Incorporating Lean Principles into Pharmaceutical QC Lab Design - White Paper

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.

Lean in Regulatory Operations

Lean in Regulatory Operations BSM have been pioneering applied research into the utilization of “Real Lean” methodologies to solve problems and generate efficiencies in Regulatory Affairs Operations (Reg Ops) in large life science companies. Operations from a Regulatory perspective encompasses the standard activities that accompany the filing of Regulatory submissions such as Labelling, Publishing, Production, Archiving etc. “Real Lean” is the term used to describe BSM’s approach to implementing Lean in a wide variety of industrial settings.

Top Labs Get Lean - Give your lab the edge

 Top Labs Get Lean - Give your lab the edgeThis 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.

Lean Thinking for Laboratories

Lean Thinking for LaboratoriesThe focus of a lean laboratory is to test samples in the most efficient way possible in terms of cost, or speed, or both. Although most of the key principles of lean apply in labs, the specific challenges facing laboratories require significant adaptation of standard lean tools.

Leaning the Batch Record Process

Leaning the Batch Record ProcessThis 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.

Value Stream Mapping

Value Stream MappingThis Article examines Value Stream Mapping - The Map of your Journey to becoming 'Lean'.It would be hard to find a medical device or pharmaceutical manufacturing site which is not currently running some kind of “Lean” initiative.

Time for Lean Thinking?

 Time for Lean Thinking?This Article examines how companies can significantly Reduce Waste and Costs by implementing 'Lean Manufacturing'.In recent times, there has been increasing pressure to reduce costs across all sections of the healthcare supply chain including manufacturing.

Implementing TPM

 Implementing TPM ArticleThis Article looks at how to best Implement TPM within life science companies. TPM is clearly best practice when it comes to the management and utilisation of equipment. It can significantly increase productivity, reduce costs, increase capacity and defer capital expenditure. 

Effective Management of Equipment

 Effective Management of EquipmentThis Article examines the Effective Management of Equipment in the Healthcare sector. TPM and OEE have the ability to create a real competitive advantage in any industry that is significantly equipment dependant.

Improving Performance through Process Re-engineering

Improving Performance through Process Re-engineeringThis article examines how companies can best Improve Performance through Process Re-engineering. The best way to achieve large scale improvement is via a cross-functional project team using a re-engineering approach….

Accelerated Release

 Accelerated ReleaseIn regulated industries, it is not unusual to find that the lead-time for final product testing and review of the batch documentation represents a significant proportion of the overall manufacturing lead-time. Given that long lead-times inevitably mean high levels of expensive inventory (and associated costs), it is no surprise that many healthcare manufacturing companies are beginning to take a hard look at their ‘release processes’ which include product testing, review and approval of batch documentation and the processing of exceptions and deviations.