We have been meeting regularly and the team is functioning well. The manufacturing associates have been gathering data by reviewing over 100 batch records.
They gathered information like bin loss, hopper loss and application yields.
We also gathered information about particle size from the batches being processed at the moment. We have a new piece of equipment on site for analysing particle size but it is not qualified yet.
To ensure that the equipment is reliable we have taken samples and analysed the samples with the new equipment and the sieve shaker used in the laboratory. The results were surprisingly very close to each other.
We continue to use the equipment but only for information purposes. The team don’t think particle size is important but I feel that it could be valuable information.
We also did a process capability on the batches and a run chart to show our progress.
With the help of our statistician, we did a gauge R&R study
The table indicates that there is a statistically significant difference between the operators but no significant difference between parts (individual results) or operators by parts (the expected variances and standard deviations are almost zero).
The indications from our measure phase are that 115 TC should be the number of timing coats to use to get the desired profile.
However we will perform a risk assessment and after that we will determine the route to go. We have spoken to our Quality and Validation departments and they have confirmed that any changes made will need to be monitored under a VCA (validation corrective action).
The member of our team that deals with compliance has reviewed the current regulatory filings and we do have scope for introducing process improvements.
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