Real Lean Transformation

Blogs

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.

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?

Waste in Laboratories

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

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.

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.

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. 

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!).

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.

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?

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.

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.

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.

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.

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)

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

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.

Lean Organisation for Lean Programmes

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.

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?

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.

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).

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. 

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.

Real Lean – What's in a name?

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

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.

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.

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