FDA audit response status update – December

Hello everyone,

We have made a lot of progress on our FDA Audit response goals, and I wanted to let you know how things are going.

Training

All of our 2,600 manufacturing employees in Bloomington, Spencer, Canton, and Ellettsville have been trained on our new approach to nonconforming product. Manufacturing began tracking nonconforming products in early November.

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The reports below include the status numbers from P48, Ellettsville, and Canton.

Manufacturing Instruction Review

To make it easier to track and analyze the data from nonconforming product, we needed to more clearly define the processes in our manufacturing instructions. These instructions are the steps that our assemblers follow to build a product. Engineering and production have been working together to review those processes. I’m happy to say that this work is almost complete.

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Change Requests

Once manufacturing instructions are reviewed and marked up with changes, the next step is to route and approve those requests. We expect the number of completed change requests to rise quickly now that the manufacturing instruction review is almost complete.

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Process Validations

Many of you have commented on the number of validations left to complete. The engineering team has been working since September to validate more than 400 of the processes we use to build our products. It’s a big number, but don’t worry. We started with the processes that are a priority for the FDA, and by the end of the year, 80-90% of those validations will be done. We set the date of December 31 for ourselves, and we are pleased with the progress we’ll be reporting to the FDA at the beginning of January. The remaining validations will be complete before our next report to the FDA in April.

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RPNs Linked to Processes

Once the right processes are clearly defined during the manufacturing instruction review, the next step is linking each of our 16,000 product RPNs with the correct process. So work orders will include the process specific to the RPN, and recording nonconforming products will be easy. Production has already started matching up the RPNs to the processes, so you’ll see the number completed grow quickly over the next two weeks.

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There has been good progress, and a lot of work will happen in the next few weeks, even over the holidays. I‘ll provide another update in early January. I appreciate the effort and focus that everyone involved has given to this initiative. See this week’s full dashboard report here.

Thank you!
Pete