Improve phase

The team have been working well and we are on schedule with our project. We agreed on 115 timing coats per batch on day 1 based on the review of the 4 batches done under VCA.

Our validation department have requested that we track the next 8 batches under VCA and that we submit a manufacturing engineering report when it is completed. We have also to manufacture these batches under process deviation as we are making changes to the batch record. The changes are not implemented yet.

We successfully processed the 8 under VCA. We then proceeded with another 20 batches and hit a Road block. We had 2 out of spec batches as can be seen from the graph below.

6^th hour dissolution Run chart

We called an emergency meeting to root cause analyse and we performed a fish bone. All the manufacturing associates that were involved in processing the batches were interviewed. The laboratory personnel that tested the batch were also interviewed.

Fish bone

Both the manufacturing associate and the laboratory person that tested the batch had observed that the bead was bigger than normal. It was now time to check our particle size after the applied stage as we had been removing a 10 gram sample for analysis with the EYECON particle size analyser The samples were not analysed yet so we proceeded to perform the analysis on the batches. The table below shows the results of the 28 batches analysed and to our surprise there were 2 batches with larger bead than the other 26 batches and both were outside specification on dissolution.

Particle size analysis

What caused the larger bead?  It was time to go back to Gemba and check the CF room and Compu 4 system. We reviewed the data on the batch report and found that a critical parameter (the rotor speed had not been adjusted when it should have been. The associate that had manufactured the batch had not increased the rotor speed at the required time and this caused the bead to get larger early in the batch which had the affect on the sixe of the bead at the final stage of processing.

I had to prepare slides for our Product review board and state the case for not stopping the project and reverting back to 75 timing coats at day 1. Before the presentation there was a lot of doubt but at the end of the presentation it was agreed to go ahead.

The project has still remained on track despite delays in implementing changes on our batch record and SOP’s which are currently in change control. We are now keeping a closer watch on the particle size until the EYECON has been qualified which is currently under way after a recommendation from the Product Review Board. The Product review board also recommended that we immediately but the capsule batches using these components on for stability purposes to ensure that the stability of the batches are not affected.

Gant Chart

With the exception of the 2 batches that are outside specification the other 26 batches processed at 115 timing coats have met the acceptance criteria. They will not require further timing as the profiles are suitable to use in the bead blends with our current safety stock of components. We will now continue to monitor the batches and evaluate the savings being made for the product.

Regression analysis was not applicable as there was no change in the processing parameters. We did do a Regression analysis just to see what appeared but there was nothing of benefit.