Lean QA

Managing Non-Routine Work

Published by Adrian Fegan in Lean Laboratory, Lean QA on April 11, 2018

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.

Use Real Lean as your first step to release capacity

Published by Ger Conolin in Lean QA, Lean R&D on September 2, 2015

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?

Published by Ger Conolin in Lean Laboratory, Lean QA, Lean R&D on August 28, 2015

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.    

The ‘Checklist Manifesto’ - Saving Lives with Standard Work…?

Published by Patrick Conneran in Lean QA on September 11, 2013

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?

Published by Melanie Watson in Lean Laboratory, Lean QA on September 9, 2013

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

Published by Patrick Conneran in Lean QA on August 21, 2013

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

Published by Patrick Conneran in Lean QA on August 21, 2013

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?

Slow down… so that you can speed up

Published by Preston Chandler in Lean Laboratory, Lean QA on April 2, 2012

Slow down....so that you can speed up. Sounds like something Yoda would say. Component sub-optimization for increased system performance.