Six Sigma Project - Control Phase

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

                                                                   Control Phase:

As a result of all four previous phases, the team now have all the information required in order to complete the key tasks as outlined in the Project Charter.

Within the Project Charter, the problem statement states that there is no procedure in place in order to proceed with production, the goal statement looks for a way forward in order to continue filling, and the project scope looks for a process to be put in place to give instructions to run the filling line in the event of a sensor failure.

In this Control phase, all the information on the isolator sensors is gathered together and it was left to myself to put it all together into our companies procedural format. This Standard Work Instruction would then be put into the Vial filling rooms procedures within its controlling Standard Operating Procedures.

Image showing section of new SWI

The above image shows the required details as required by the vial line operator should sensor number 83B1 fail during production of a batch. This same information on the tag ID, description, PLC address, SAP numbers and instructions are outlined for all individual sensors within the vial isolator.

The only exception to the above is where certain sensor types could be grouped together in table format as in the isolator doors, temperature and humidity sensors. These are shown in the following image which is also taken from the new SWI.

Image showing details for grouped sensors

For completeness, and also to ensure that what is stated in the SWI is fully correct, the team have requested that we book some additional time on the line in order to redline the SWI before handing over to operations. This has yet to be scheduled. Once this is complete we can commence the close out of the project and meet with all stakeholders for final handover.