Real Lean Blogs
Lab Testing - The Prioritization Problem
Lab testing schedules are often dominated by complex prioritization strategies but there is a less stressful way to successfully deal with samples. BSM can help you break out of backlog and improve your labs KPI's and performance.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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?
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.
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.
Applying Lean to the Lab through Visual Management
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 – 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…?
The ‘Checklist Manifesto’ - Saving Lives with Standard Work…?
A recent bestseller expounds the benefits of a simple tool that is being used to save lives in hospitals around the world. How can we apply the same tool to improve quality outcomes in other processes?
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.
Lean QA - Audit Management
Most pharmaceutical companies have a cGMP auditing program administered at the site and corporate levels of the organization. Given the success seen through the implementation of Lean in QC and Manufacturing, many organizations wish to extend these initiatives to their audit function in order to improve productivity and service level, and lower costs. However, faced with a constantly evolving regulatory environment and increasingly varied processes and facility types (manufacturing, warehousing, contractors, suppliers etc.), can Internal Audit functions improve their operational effectiveness while maintaining the same level of regulatory oversight?
Lean QA - Audit Management
Most pharmaceutical companies have a cGMP auditing program administered at the site and corporate levels of the organization. Given the success seen through the implementation of Lean in QC and Manufacturing, many organizations wish to extend these initiatives to their audit function in order to improve productivity and service level, and lower costs. However, faced with a constantly evolving regulatory environment and increasingly varied processes and facility types (manufacturing, warehousing, contractors, suppliers etc.), can Internal Audit functions improve their operational effectiveness while maintaining the same level of regulatory oversight?
