Consumable operations - the folks producing the GeneXpert cartridge, the company's high-volume product - is a rudderless ship. No MES or other functioning data system exists to comprehensively track failures, which doesn't lend itself to troubleshooting the myriad serious problems plaguing the operation. The whole manufacturing workflow is a held-over afterthought from the early days (10-15 years ago) and has not, to date, been revisited. The raw materials and finished product are rolled around the building in plastic trays, Ziploc bags, Tupperware tubs and the like, fine for expensive parts but utterly inappropriate for a factory attempting to produce units in the hundreds of millions per quarter. Recurring equipment failures and poorly-conceived mechanisms are common and no program (CIP?) is in place to improve or eliminate them. The overall impression is that management is so enamored of their game-changing "help the world" nature of the product - which it doubtless is - that the niceties of a controlled production process are lost on them.
