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.

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. 

Six Sigma Project - Analyse Phase

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

In the previous Measure Phase we looked at the extent of the problem regarding sensor failures and also the current process map in a Recovery state.
Here in the Analyse phase the team looked at how the ideal process map should look. This takes into account continuous batch filling from start to finish, without any need for a batch recovery.

Future State Process Map

We also completed an Ishikawa or fishbone event on a failed grade A Isolator sensor. Here, we looked at each and every possible reason for component failure. At this stage it is looking like there will be numerous mini projects resulting from this event in order to rule out some of the suggestions. These cannot be completed at this time due to the timeframe for completion of this Green Belt project and also the resources required for those minor projects. These will be noted and referred to in the recommendations section of the project report.

Ishikawa Diagram

The biggest event and also the one which took up the most time during this phase was the FMECA event. Where some companies just do a FMEA, we also bring into play the Criticality factor. The preparation hours for this event was extensive and also the commitment by the team during the event is to be commended. The event was held over almost two days with subject matter experts from other departments like Tech Ops and Engineering called on to answer any questions we had on occasion

Sample section of the FMECA file

The team are now focusing on the next Improve phase. The production timeslot has been booked on the line, we will need to be well prepared to get our testing completed in the time provided. 

Six Sigma Project - Measure Phase

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

In this measure phase, the teams tasks were to analyse the current process and collect data from previous manufacturing batches incl. commercial, clinical, PPQ (Process Performance Qualification) Engineering, Process Simulations, UAT (User Acceptance Test) etc.
We were present in the production room in order to map out the steps in the current process from start to finish. We reviewed the process and its boundaries as defined for this project. We identified each step as it occured in order and the tasks were numbered sequentially through the most direct route. While mapping the process through each stage, we tried to ask, "Why are we doing tasks that way? and, Would it be possible to do things alternatively which would help here?
I took all the information and transferred it to MS Word using the relevant symbols etc. The Process Map for vaccine filling where a recovery is requiring implementation is shown below.

Process Map - Measure Phase

In our company we use SAP as our CMMS (Computerised Maintenance Management System) and also in our Quality Systems. I conducted a search in SAP to check for the details of previous QNs (Quality Notifications) or Deviations which occured as a result of a sensor failure within the Isolator. This search gave results of twelve QNs from August 2012 to October 2015.

Historical data showing faults resulting in Batch Recovery

The above data is shown graphically in the following Pareto.

Pareto of Sensor Faults

For the upcoming Analyse Phase, a two day FMECA has been scheduled. This has already had to be re-scheduled due to participants availability within production activities. My preparation work for this event is now underway. 

Six Sigma Project - Define Phase

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

In our biopharmaceutical company we have a grade A isolator within a grade C room. While aseptically manufacturing sterile vaccines, it has previously occurred that a sensor has failed within the sterile isolator. If this faulty sensor were to be simply removed and replaced with a new one this would then expose an unsterile surface where the original sensor was fixed to the isolator. (Isolator sterility occurs using vaporized hydrogen peroxide) We therefore have to stop the batch, empty and clean the isolator, implement batch recovery then start a new batch. This results in downtime of approx. 30 hrs. along with waste of consumables and the cost of a Quality Notification (QN). 

In 2016 our company has progressed from that of a startup company to a sustainable production facility. This year we will be producing 3.6 times more doses as we did in 2015. It was therefore requested by the Assoc. Dir. Operations that a team be put together to use the DMAIC model to target the higher causes of downtime which occurred in the previous year(s).

           The team was selected in Q4 2015 and included Maintenance, Automation, Operations and Reliability Excellence personnel. In the Define phase I met with Operations and Quality leads and also with the Site Leadership Team to conduct a VOC. The detail of the VOC will be shown in the project report.

          One of the main challenges I encountered in the Define phase was to obtain the input from the various departments of their views for the VOC. The site has become increasingly busy and people are being stretched from one project to another. The allocation of time allowed by the team to focus on the project is another concern. I will be meeting with the various team member managers to discuss this and also give updates over the duration of our project.

            Above shows our SIPOC high level process flow for a batch recovery. This was a great eye opener for the team as we saw the problem as a whole and the effects it had on each customer area / dept.

             The Project Charter was also completed during the Define phase. Background information on the schedule for 2016 and information on the parts of the Isolator were also gathered.