Lean tools for Laboratory

Laboratories, like any other process stream, contain both value-added and

non-value added activities. Depending upon the function of the laboratory

in the product development lifecycle the distribution of responsibilities may

change but the basic challenges are universal for all laboratories. For example,

product development laboratories have to balance the need to support new

product development and regulatory filing support with clinical supply release

and stability while the commercial quality control must support new and

commercial product release and stability testing. The reality is all laboratories

suffer from similar challenges to their effectiveness:

Highly variable lead times

? Many laboratories try group testing for equipment to minimize

equipment setup, media, and sample preparation. This makes

equipment capacity planning very difficult to do. This inability

to forecast spills over into the resource planning function as

well.

Highly variable incoming workload

? Most laboratories experience significant peaks and troughs

of activity because of the highly variable nature of incoming

samples. This is one area that benefits naturally from greater

predictability on the shop floor and across the product supply

chain. Understanding the drivers which affect this variability is

central to establishing a more predictable laboratory operation.

Without this, the result is often missed delivery deadlines and

extra resource requirements because of cascading inefficiencies

in the execution of the laboratory.

Lack of resource planning system

? Many laboratories rely upon the laboratory manager or

supervisor to assign responsibilities within the laboratory on a

daily basis. Without a clear understanding of the effort and time

required for each analytical testing value stream any resource

the decision is a guess at best.

Poor laboratory layout

? There is always some planning involved in the layout of the

laboratory but typically the considerations are space and

support utility requirements rather than optimal efficiency and

minimum effort. This is compounded by disorganized laboratory

supply schemes resulting in overstocking of unnecessary items

and expediting critical items.

Poor analyst cross-training

? Most labs have a clear program for training and qualifying

analysts on an analytical test. However, without a clear

understanding of the testing demand and bottlenecks in

the laboratory it becomes very difficult to effectively assign

resources and prioritize testing.

Too much work-in-process

? There is no sample flow in the laboratory despite significant

analyst effort to complete testing. This could be created by

bottlenecks in data review, test approval, and out of specification

(OOS) investigations as an example.

Poorly implemented LIMS systems

? The ability to realize the benefits of automated information

systems is completely dependent upon how they are deployed

in the laboratory. The lack of a well thought-out implementation

plan will often result in an increase in the amount of work in the

laboratory. Automation for the sake of automation will rarely

realize the benefits it was intended for.

Poor use of Lean tools

? What makes Lean so universally acceptable is that the tools are

simple, intuitive, and in most cases easy to implement. However,

if these tools are not reinforced, measured, and maintained the

realized and future gains in a laboratory will quickly disappear.

Lean Tools for the Laboratory

The framework for improving the efficiency of a laboratory is the same as can

be applied on the shop floor. Figure summarizes the components that are

effective when applied in the laboratory setting.

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