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.