Articles and Reports

Metrics Methodolgy

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Metrics Methodology

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

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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.

Unlocking Potential in your Regulatory Affairs Organisation

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Unlocking Potential in your RA Organisation

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.

Real Lean in Quality Assurance Report

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Real Lean Quality Assurance

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.

Lab Excellence in R&D

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Lab Excellence in R&D

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

Top Labs Get Lean - Give your lab the edge

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Top Labs Get Lean - Give your lab the edge

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.

Incorporating Lean Principles into Pharma QC Lab Design - Article

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Incorporating Lean Principles into Pharma QC Lab Design - Article

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.

Incorporating Lean Principles into Pharmaceutical QC Lab Design - White Paper

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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 Thinking for Laboratories

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Lean Thinking for Laboratories

The 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

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Leaning the Batch Record Process

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.

Lean in Regulatory Operations

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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.

The Journey Towards Self Managed Teams

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The Journey Towards Self Managed Teams

Management is not easy never mind self management. Teams need lots of support in the early stages of the journey towards selfmanagement and ongoing assistance thereafter. In truth very few teams in sphere of activity achieve total self management.

Accelerated Release

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Accelerated Release

In 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.

Achieving 6 Sigma Performance in Business Processes

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Achieving 6 Sigma Performance in Business Processes

This article outlines how 6 Sigma can be pursued in a business process by using the same steps and techniques as used to improve a physical process.

Value Engineering - The search for unnecessary cost

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Value Engineering - The search for unnecessary cost

This article examines Value Engineering (VE). VE is a complete system for identifying and dealing with the functions that cause non-contributing cost or effort in products, processes or services.

Improving Performance through Process Re-engineering

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Improving Performance through Process Re-engineering

This 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….

TPM and OEE in the Irish Healthcare Manufacturing Industry

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TPM and OEE in the Irish Healthcare Manufacturing Industry

This Report examines the key strategies of TPM and OEE and the results of BSM's Benchmarking survey on TPM and OEE in the Irish Healthcare Industry.

Effective Management of Equipment

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BSM Equipment Management

This 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.

Implementing TPM

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BSM Implementing TPM

This 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. 

Time for Lean Thinking?

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BSM 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.

Value Stream Mapping

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BSM Value Stream Mapping

This 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.