She doesn't look at the machines. She looks at the filing cabinets. Her name is Ms. Chen. She arrives at 9am with a rolling carry-on bag, an iPad in a hard case, and the specific kind of calm that belongs to people who have seen this before. Many times before. The plant manager gives her a tour. New equipment. Clean floors. Calibrated instruments. He is proud of the production line. He should be. It's good work. Ms. Chen walks the line for two hours. She says nothing. She writes nothing on her iPad. Then she turns to the plant manager and says: "I'd like to see the production records. All of them. Going back eighteen months." The plant manager smiles. He has been preparing for this question. He did not prepare for the answer to be complicated. Here is what Ms. Chen finds: The production floor: acceptable. The equipment: calibrated, documented, within spec. The documentation: Batch records exist in three formats across four departments. No single record contains the full picture of any batch.…