Real Lean Transformation

Lean Lab

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.

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).

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)

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.

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.

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.

Understanding Service Level Agreements in Lean Projects

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. 

Importance of including Lab Planners when designing Lean Lab solutions

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 Trouble with Dedicated Resources: Leveling the Workload

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!).

Structured Problem Solving – the Missing Link in Labs

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…?

Paperwork Review in QC Labs – are Dedicated Resources a good idea?

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.

Making Sense of the Chaos in Laboratories

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.

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?

Lean Thinking for Laboratories

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. 

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?

Waste in Laboratories

Laboratories are not the same as manufacturing environments so do the standard Lean ‘Wastes’ even apply in Labs?

Optimising QC Lab Testing

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?