Real Lean Transformation

Lean QA

Read what our consultants have to say about Real Lean in Quality Assurance. For further information please contact us. 

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.

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.

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.    

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.

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.

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.

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.

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?

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.