Laboratories are not the same as manufacturing environments so do the standard Lean ‘Wastes’ even apply in Labs?
Real Lean Transformation
Laboratories are not the same as manufacturing environments so do the standard Lean ‘Wastes’ even apply in Labs?
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.
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!).
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.
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.
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.
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.
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)
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.
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.
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).
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.
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.
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.
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.
When designing lab solutions, Analysts, Lab Managers, Supervisors and Approvers are all important stakeholders. The solution will be designed so that these stakeholders can carry out their tasks as efficiently and obstruction-free as possible. However, it shouldn’t be forgotten that the lab Planner is also a critical stakeholder, and planning of the workload, both for the lab as a whole and for individual analysts, is the first step to ensuring a levelled workload and flow through the lab.
The effort to make the work and processes visible, in a work environment, is called visual management. In general, there are a couple of key items for any successful application of visual management.
Structured Problem Solving has been one of the foundations of Lean transformation, and of almost any high performing company over the past 50 years. However, many labs reject Structured Problem Solving techniques outright, or use them as a ‘box – ticking’ exercise to satisfy management that they are adhering to the latest directive. Why is it, when successful organisations pride themselves on a culture of continuous improvement and problem-solving, that in Labs, it is often the missing link to true transformative improvements…?
Pharmaceutical testing laboratories face many challenges including high volatility in incoming workloads, non-optimized analyst roles and undefined testing sequences. These issues are often ‘managed’ by dedicating resources to specific tasks and creating subject-matter experts in an attempt to improve performance and reduce errors. More recently there has been a move towards dedicated reviewers, where analysts are “promoted” off the bench into full-time review roles.
To an outsider (and often even the insiders) laboratories can seem like a workplace hovering on the brink of chaos. The lab is constantly bombarded with hot requests for this lot or a special test for that project. Investigations, vacations, changes in product, adjustments in mix, FDA inspections, equipment issues and narrowly specialized analysts can often add to this sense of chaos. Usually it is difficult to see how work flows in the lab, if in fact it does flow. It can also be next to impossible to identify what is “normal” behavior. One of the critical steps in creating a Lean Lab is separating the routine (or in some cases, the most routine) from the non-routine or non-predictable.
Slow down....so that you can speed up. Sounds like something Yoda would say. Component sub-optimization for increased system performance.
Deployment of 5S in a laboratory setting is a time consuming effort and one which in itself delivers little in terms of productivity gains. So why bother…?
While it might sound like some sort of fad diet, “lean” in the context of business improvement refers to a specific methodology that originated in the Japanese motor industry toward the end of the 1980s. Over the decades, this lean philosophy has been successfully adopted by many companies across a broad spectrum of industries and, more recently, lean thinking has filtered into 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.
Day to day operations of individual departments in life science companies rely on many decisions made outside of each department’s own remit. When embarking on a Lean strategy, the pillars of operational excellence (Levelling and Flow) can be supported by increasing awareness of how each department functions and explaining constraints.
Recently in laboratories, there has been a notable shift towards dedicating resources to specific work streams and sub-streams, in the attempt to improve service levels. This is due in large part to a misapplication of the key Lean principle of developing ‘Value Streams’.