This case concerns the QA Analytical Laboratories on a UK site of one of the world's largest pharmaceuticals manufacturing company.

The challenge for a QA/QC laboratory is to maintain their analytical excellence and combine that with an equal capability to manage resources to meet the operational performance levels needed by their overall organisation. Often, operational performance requirements will include, for example, laboratory throughput performance and the ability to meet deadlines or due-dates for completion of tests analysis, dependably.

A large financial and training investment has been made by many analytical laboratories in analytical technology and in data management systems (eg. Laboratory Information Management Systems - LIMS).

Strangely, there are few if any  tools or systems commercially available to laboratory managers to help them manage operational performance. That is, there is little help available to laboratory managers in ensuring their laboratories give the required levels of service to those they serve. The focus has historically and continues to be, analytical technology. We set out to redress this imbalance.

We worked with our pharmaceuticals client to evaluate the operational requirements and design a laboratory management system by which to plan, schedule and manage the operational performance of their QA/QC laboratories. Our client sponsor made the comment: "btt's solution brought the management of laboratory activities to the same professional level as that of the analytical science employed".
 

On completion, our client declared the benefits as they saw them of the Laboratory Scheduling capability as this: -

• improved timeliness of test completions

• reduced cycle time for test completions (ie. analysis times can be managed - short or long - to meet priorities)

• ability to publish meaningful laboratory schedules to their customers (ie. the internal and external organisations they serve)

• understanding of the impact of changed circumstances on plans

• enables them to make best use of key analysts & critical instrumentation

• smoothing-out for resources of varying workloads

• regular and insightful management information about laboratory performance

• "What-If's" on laboratory capacity planning & costs projections

Those benefits were in the context of a complex and difficult management planning environment which was characterised by:

• lumpy incoming workloads (somewhat unpredictable peaks & troughs and shortage of reliable forecasts)

• varying product mixes (and test combinations)

• priorities for most urgent completions change (some analyses take priority - what is thes effect on the others ?)

• competition or contention for resources

• analyses can fail and retests are needed (disruptive)

• resource limitations (skilled analysts, instrumentation, floor space, etc)  - which lab manager would agree they have enough !?

• re-allocation of staff periodically to non-analytical activities (Analysts may need to develop new methods or other non-benchwork activities

• availability of Analysts and instrumentation cannot be guaranteed (holidays, sick leave, equipment downtime)

Client comment: "Btt's approach identified and facilitated new ways of working which improved laboratory and overall supply chain reliability"

This Btt project has been presented by our client GlaxoSmithKline at LIMS conferences in London (2001) and Berlin (2002). Btt presented the essentials of the project at the Royal Society of Chemistry AAMG e-Lab conference in London in June 2003 and the international LIMS Conference in Barcelona (October 2004). The presentation abstract is available here: "Managing the Laboratory for Better Performance". Further information on this approach to managing laboratories and improving their performance is given on the next pages.

About the author: Chris Dale

Related articles: Laboratory Process Flow, Btt Scheduling Engine, European Pharmaceutical Review June 1998

Books: The scheduling system mentioned in this article was based on an automated application of Eli Goldratt's Critical Chain principles. For information on Critical Chain and its underlying Theory of Constraints, see these books: Critical Chain, Theory of Constraints, The Race, The Haystack Syndrome.

Other references, amongst many, were: Project Management in the Fast Lane, Critical Chain Project Management

For general background: Btt principles

For training in Critical Chain using ProChain software (used in the Btt scheduling system): Focus 5 Systems

To raise questions or discuss the subjects further...  questions.