Ÿ Groups finalize and test a change that is aimed at mitigating the ineffective process

Ÿ Improvements are ongoing and include feedback analysis and stakeholder participation


Confirm results

Ÿ Determine if the processes in the FSL is bringing output/results within specified limits as improvements are implemented (e.g. TAT remains within 14 days, Bg drops in each laboratory discipline)

Ÿ Reduce spread of output data after knowing the reasons for spread

Ÿ Descriptive statistics with Six sigma concept

Ÿ Process capability

Ÿ Data gathering

Ÿ Maintaining process stability and sustainability


Develop metrics that help leaders monitor and document continued success.

Ÿ Six Sigma strategies are adaptive and on-going

Ÿ Adjustmentscan be made and new changes may be implemented as a result of the completion of this first cycle of the process

Ÿ At the end of the cycle, additional processes are either addressed or the initial project is completed


Analysis of the measurement system

Computerize all data collection systems to allow for correct and reliable data for analysis and implementation of controls in the process

Ÿ Descriptive statistics


Determine process capability

Compare outputs/results under control with desired or specification limits

Ÿ Basic statistics

Ÿ Process capability


Implement process controls

Ÿ Implement control actions to determine if Bg, Tsc, Ab, TAT remain within control.

Ÿ Concentrate on established critical control points

Ÿ Use automated data collection systems to trigger messages for action

Ÿ Involve laboratory managers, directors and analysts to participate (process owners) in the observation and taking corrective measures


Ÿ Control plans

Ÿ Control measures

Ÿ Process control

Ÿ Process documentation like LIMS

Ÿ Transfer ownership to process owners