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.
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.
The above data is shown graphically in the following Pareto.
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.
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.
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| Process Map - Measure Phase |
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| Historical data showing faults resulting in Batch Recovery |
The above data is shown graphically in the following Pareto.
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| 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.
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