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One day the phone rang at the Office. It was my favorite type of call: an existing client with a new problem.

The lady on the phone was a Manager at a very large pharmaceutical manufacturing facility. They had a big problem; a “483”.

A “483” is a warning letter from the FDA, based on a recent inspection of a manufacturing facility. This is big news in pharmaceutical manufacturing, because if you don’t remedy the problem, the FDA can shut down the facility. This particular facility employed 8,000+ people, and the 483 covered the part of the campus that manufactured a substantial portion of the product flow.

We had done several shop floor automation projects for this group before, around tracking of equipment with barcode scanners in a controlled batch manufacturing environment. In that environment, a record was kept of every step in manufacturing a batch: the Lots of material that went into it, the people who worked on it, the rooms in which it was prepared, and every tray, ladle, paddle, vessel and rack that was used in the process.

The immediate problem, though, was bigger than that. The client had a process for tracking problems or issues that came up in the preparation of a batch – a paper process. With the best controls in the world, occasionally something went wrong. With so many steps, ingredients, process constraints and documents, and at large batch volumes, something was documented every few days.

Very, very occasionally it was something serious, like contamination or expired ingredients. But mostly it was documentation errors: a missing signature, a missing training record for a crew member, a misplaced equipment cleaning record. Or minor process errors – 1 extra minute drying time, or a larger than specified vessel used. If you saw the paperwork needed to manufacture a batch of drugs, you would understand one reason why drugs in the US are so safe, and so expensive.

The unit used a paper documents to track such issues. The documents were summarized every month into a key process quality report reviewed by senior management. The report wasn’t called the “mistakes” report, or the “problems” report. These weren’t mistakes; they were “Atypical Batches” in the parlance of the industry.

The client needed a new Atypical Batch Reporting System, ASAP.