Real Lean Transformation

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3 Important Questions to Consider when Designing Labs with Lean in Mind

Building (or refurbishing) laboratories is a costly and time-consuming activity for a company. Poorly designed spaces can be costly in terms of lost productivity, slower turn around times and higher inventory of equipment and consumables. It is also common for the process to become a bartering exercise between groups for space, equipment and resources.

1. How will the space be used? Read more about 3 Important Questions to Consider when Designing Labs with Lean in Mind

Project Based Labs

Laboratories with project based workloads often have greater volatility in both the volume and mix of work than other lab types. The work content of later steps may only be clear after the preceding step is complete.  This all adds to an inherently unpredictable workload, both for the overall lab and for individual personnel. But there are some core strategies that you can deploy to make project labs more productive. Read more about Project Based Labs

Raw Materials / Consumables Laboratories – Understanding the Nuances and a Strategy to Ensure Best in Class Performance

Raw materials / consumables labs are integral to the smooth and stable operation of a production plant and as such they perform a very important function. The cardinal sin for an incoming materials laboratory is to cause a change in the production schedule due to a material not being released on time. While most plants will try to have some sort of fixed production schedule, production environments are inherently fluidic and dynamic in nature. This fluidity can negatively impact the lab; often leading to constant prioritization and re-prioritization cycles of materials to be tested in the laboratory. This means that a lot of unnecessary non value-add effort is expended on scheduling. The net effect of all of this is a pressurized environment where analysts feel that they are in constant firefighting mode. Read more about Raw Materials / Consumables Laboratories – Understanding the Nuances and a Strategy to Ensure Best in Class Performance

The Seven Deadly Sins of Lean Programmes - Why Lean Programmes often under perform

In an effort to deploy Lean across their organisations, many companies have invested heavily in large multi site programmes supported by dedicated internal Lean resources. The results from these programmes are quite often patchy and underwhelming. So why do these programs under perform? Read more about The Seven Deadly Sins of Lean Programmes - Why Lean Programmes often under perform

Bringing Flow to the Review and Release Process

The concept of flow is a key element in achieving lean operations. This fact has not gone unnoticed by laboratories but many still struggle to achieve real flow and very often the final review and release of samples can prove to be somewhat of a bottle neck. The final review and release tasks should not be thought of as being autonomous or decoupled from the testing process and should be incorporated in the flowed process. Read more about Bringing Flow to the Review and Release Process

Lean Tools versus Lean Systems

Since the emergence of the Toyota Production System (TPS) in the early nineties there have been many successful introductions of Lean manufacturing to all types of differing industries from Healthcare to Retail. Providing Lean consulting services has become big business. But without understanding the deeper principles behind Lean, companies can be too focused on the application of Lean Tools instead of deploying Lean as a holistic system. “Managers are struggling to combine lean techniques into a coherent system.” (Womack & Jones, Beyond Toyota: How to Root Out Waste and Persue Perfection, 1996) Read more about Lean Tools versus Lean Systems

Why can't my department get ahead and be productive

In operations where the short interval (e.g. daily or weekly) workload varies, the most common method of distributing the work is to share it equally between the available people. We call this method “available work through available people”. The consequence of this approach is that even low daily workloads expand to fill the day resulting in poor productivity. Carefully designed standard work can improve your department’s performance by consistently making the most out of people’s time. Read more about Why can't my department get ahead and be productive

Three Ways our Batch Records set us up for Failure (and how to address them!)

One of the ways we can improve Batch Record Right First Time (RFT), and hence throughput time, is by improving the Batch Record design.  By reengineering the document we can reduce the opportunities to make errors.  Batch Record (BR) redesign is an important part of a Lean QA (Lean in Quality Assurance) project, because it not only addresses RFT and throughput time, but it also leads to a reduced review effort (and hence workload) for manufacturing and QA reviewers. Read more about Three Ways our Batch Records set us up for Failure (and how to address them!)

Change Management in Laboratories / Quality Organizations

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. Read more about Change Management in Laboratories / Quality Organizations

Can and should Lean be applied in Labs?

Lean originated in the automotive industry and it’s easy to see how the tools and concepts are a good fit for that type of manufacturing. It’s much less obvious however that Lean can and should be applied in Labs.  In recent times Lean Lab projects have become quite common but…

Is Lean really an appropriate strategy in the Lab environment or are labs just blindly following trends? Read more about Can and should Lean be applied in Labs?

Six Steps to Successful Change Management within R&D

Leading an R&D organization is difficult. It involves assessing the environment and managing the work flow to support the process of turning innovative ideas into prosperous business results. On top of that, the environment in the life science industry is always evolving and leaders must have the ability to effectively change with the environment. Read more about Six Steps to Successful Change Management within R&D

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

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. Read more about Breaking Barriers in Pharma – How Lean processes help Information flow between Departments

Changeover Management in a Controlled Operations Environment

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. Read more about Changeover Management in a Controlled Operations Environment

Deviation and CAPA Management – Milestone Management for a Robust, Transparent and Efficient Process

 

 

It is an inescapable fact that deviations will occur at various points along the production cycle. An organization’s discrete approach to the management of such deviations will define how laborious and complicated the ensuing investigation and correction process is. In this blog, we outline BSM’s approach for the simple and effective management of deviation and CAPA (Corrective and Preventive Action) systems.

Goals of our systems include:

Flow Read more about Deviation and CAPA Management – Milestone Management for a Robust, Transparent and Efficient Process

The Paradox of Data in R&D Labs

R&D labs are in the business of generating, analyzing, reviewing and validating data. Data rules the decisions on how projects move forward through the development phases. However, we generally find that R&D labs have little or no data on their own capacity and performance. Without sufficient statistical data, the labs cannot meaningfully analyze past performance and identify opportunities to improve future performance. Read more about The Paradox of Data in R&D Labs

Labelling Updates in Regulatory Affairs: Is product specific dedication of resources a good idea?

Managing changes to the content and format of product labelling is a key function within any Regulatory Affairs Organisation. Such functions are typically structured by therapeutic area, where each provides support for a reasonably small group of specific products. Read more about Labelling Updates in Regulatory Affairs: Is product specific dedication of resources a good idea?

Applying Lean in Pharmaceutical R&D Labs

Over the past few years, many of the leading Pharmaceutical companies have rolled out extensive programmes to the labs on their manufacturing sites.  The better programmes (i.e. those based on the key ‘Real Lean’ principles of levelling, flow and standard work and properly structured and supported) have achieved very impressive results. Pharmaceutical R&D labs however, are significantly different than the Product and Raw Material testing labs found in Pharmaceutical Manufacturing so can Real Lean work in R&D Labs? Read more about Applying Lean in Pharmaceutical R&D Labs

Real Time Batch Record Review – Better Quality, More Speed, Less Cost … and Real Training!

Real Time Review™ of Batch Records can be quite a departure from the current review process in most Life Science companies.  It will typically mean migrating from the commonly found process in which you find multiple stages and levels of review, by several Manufacturing and QA personnel, to a quicker, more efficient review process. Read more about Real Time Batch Record Review – Better Quality, More Speed, Less Cost … and Real Training!

Managing Non-Routine Work

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. Read more about Managing Non-Routine Work

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

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). Read more about Time studies, work measurement and standards - how not to alienate your team

Designing Visual Management for a Lean Laboratory

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.  Read more about Designing Visual Management for a Lean Laboratory

Use Real Lean as your first step to release capacity

Faced with a need to increase laboratory testing capacity, Real Lean releases hidden capacity quickly and cost effectively.

Increased demand for lab capacity is a positive indicator of a growing business.  Deciding upon the best option to increase capacity, however, never seems to be easy!  In particular, when existing space, equipment and staffing capacity is thought to be maxed out, the next option tends to involve a space expansion (see the top row of graphic below) – a complex project with significant capital expenditure, which drags stakeholders from Engineering and Facilities, Finance and HR into the mix. Read more about Use Real Lean as your first step to release capacity

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