Six Sigma Project - Improve Phase

Project Title: Batch Recovery - Due To Sensor Failure - Reduction             Six Sigma III

                                                                   Improve Phase:

In the previous Analyse Phase we completed the future state map, fishbone and FMECA. The FMECA gave us – among other information - classroom based results of potential sensor failures.

Now in the Improve phase, the team met in the grade C filling room to conduct testing on each isolator filler sensor. The purposes of the tests were to deactivate each sensor and then obtain factual controls or workarounds in order to proceed with production activities to complete the vaccine batch if possible.

Sensors tested during Pilot Study

We operated from left to right ensuring to complete tests on each sensor as we progressed to the end of the Isolator. We disconnected each sensor & observed the alarm shown on the machine control HMI. This alarm was cross referenced with the Isolator manufacturers operating and maintenance manuals to ensure the correct error was occurring & then to observe manufacturers recommended solutions.

Detailed notes were taken on each sensor test to outline the following:

·        Alarm name
·        Sensor number
·        Sensor type
·        Sensor purpose
·        Observations and results of sensor disconnect
·        Manufacturers name and SAP reference numbers
·        Results of test – Continue production or Batch Recovery

The results for one of the sensor tests are shown as follows;

Sensor Test Notes

The team are now left to focus on the final Control phase. Here we must ensure that the goal statement is achieved while addressing the problem statement and remain within the defined project scope.