The challenges facing Quality Assurance Teams in Cell Based Therapy Companies. Optimizing Quality Assurance for Cell-Based Therapies: Meeting Unique Challenges with Real-Time Review and Lean Solutions for Quality Assurance in Personalized Medicine.
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.
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.
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.
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.
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.