Lean Laboratory

Lab Testing - The Prioritization Problem

Published by Adrian Fegan in Lean Laboratory, Lean R&D on September 4, 2018

Lab testing schedules are often dominated by complex prioritization strategies but there is a less stressful way to successfully deal with samples.

Understanding Service Level Agreements in Lean Projects

Published by Adrian Fegan in Lean Laboratory on September 4, 2018

Service level agreements provide a basis for the metrics against which performance of groups are measured. Discussing and understanding the reasons for (or even implementing) service level agreements are an important initial stage of Lean projects. 

Change Management in Laboratories / Quality Organizations

Published by Gerard Doorley in Lean Laboratory, Lean QA on September 4, 2018

BSM lead large, transformative change initiatives on sites across the world in the pharmaceutical and life sciences sectors. Management of such initiatives is not trivial and can indeed be quite difficult, but the benefits that can be realized constitute a marked improvement on the status quo. Over the past decade, BSM have developed detailed and structured methodologies to ensure that change is implemented smoothly and, most importantly, that it is sustained into the future.

Changeover Management in a Controlled Operations Environment

Published by Gerard Quigley in Lean Laboratory, Lean QA on July 26, 2018

Time in an operational environment can be classified as (1) processing time and (2) non-processing time. Focusing solely on making the processing time efficient is a significant cause of lost improvement opportunities.  Standardising variable non-processing time activity (e.g. changeovers) can realise a surprisingly large improvement: a typical changeover standardisation program alone usually achieves 50%+ reduction in changeover times.  This increases the time available for processing, but also increases yield and the productivity of resources.

Breaking Barriers in Pharma – How Lean processes help Information flow between Departments

Published by Andrew Harte in Lean Laboratory, Lean QA, Lean R&D on July 26, 2018

Working as a consultant for different pharmaceutical companies I have come across some interesting examples of how “walls” between departments and between companies affect operations. One complaint you often hear within the industry is that of poor communication between the Manufacturing Department (who manufacture the product) and the Quality Department (who Inspect, test and release the product). I came across one particularly poor example of this last year.

Managing Non-Routine Work

Published by Adrian Fegan in Lean Laboratory, Lean QA on April 11, 2018

Every Department (QC, QA, R&D, RA, Manufacturing, etc.) has its share of non-routine work that must be completed.  This can include new instrument qualifications, method validations/transfers, SOP reviews, batch record updates, etc. It is easy for these tasks to get lost in the mix of all the other work. This is of course until there is a hard deadline or annual reviews are approaching! Then resources have to be dedicated to these non-routine projects to ensure that they are completed on time. While this is happening routine work is building up and once the project is cleared we have to set about dealing with the backlog.

Time studies, work measurement and standards - how not to alienate your team

Published by Andrew Harte in Lean Laboratory, Lean R&D on April 11, 2018

A critical component of improving any existing process is first measuring it! “If you can’t measure it, you can’t improve it.” (Bohmer, 2008) There are multiple tools for determining a process’ baseline, such as process mapping and spaghetti diagrams. Possibly, some of the more controversial tools are those used for work measurement and standards. There are four recognized methods for gathering information on the time it takes to perform a task (or set of tasks).

Designing Visual Management for a Lean Laboratory

Published by Noelani Roy in Lean Laboratory on April 11, 2018

Visual management is an integral part of a Lean Laboratory. It unites personnel around a common goal, ensures that critical information is disseminated, and keeps the lab running smoothly. When a visual management board is well designed, anyone should be able to walk in and have a clear understanding of the labs operational status and current performance. 

Real Lean – What's in a name?

Published by Ger Conolin in Lean Laboratory, Lean QA, Lean R&D on August 28, 2015

Real Lean is the term used by BSM to describe a specific methodology, one which enacts the actual core principles of lean and delivers real value stream optimisation, both financially and operationally, for its clients.    

Real Lean: A Specific Approach to Generics

Published by Melanie Watson in Lean Laboratory on August 20, 2014

Ever since its first introduction by the Japanese automotive industry in the 1980s, lean manufacturing has been successfully adopted by many companies. For more than 10 years BSM have been global leaders in the provision of “Real Lean”. Now, BSM are implementing “Real Lean” in the generics Life Science industry. This effort is not without its difficulties, providing many unique challenges and customization of the lean process.