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.
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.
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.
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.
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.
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.
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.
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….
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.