Real Lean Blogs
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.
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.
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?
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.
Laboratories are not the same as manufacturing environments so do the standard Lean ‘Wastes’ even apply in Labs?
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)
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.
Dedication of resources may seem like a good way to have “Subject Matter Experts” (SMEs) get through work quickly, but it gives rise to a costly productivity penalty. The antidote is to level the workload across the team (without compromising the important role of the SME!).
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.
QC test methods and the overall testing approach employed in laboratories can themselves be inherently wasteful. What steps should be taken to identify and eliminate such waste?
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.
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?
Do you want to reduce lead times while improving productivity in your QC testing laboratory? Read the following case study to find out how.
Lab testing schedules are often dominated by complex prioritization strategies but there is a less stressful way to successfully deal with samples.
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.
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.
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.
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.
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.
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.
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.
You’re a site leader three months into your Lean Programme and on the face of it things are going well but you’ve got doubts that the organisation structure is supporting your lean journey in the way you’d want.
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.
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?
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.