What's actually broken in chemical quality management
In most chemical manufacturers the quality system was bought to solve document control, and it did. What it never solved is the join. A deviation is raised against a batch that lives in the ERP, investigated against a specification that lives in a spreadsheet, and closed against a CAPA that lives in the QMS. Three systems, one event, and a person keeping them aligned.
The cost shows up at audit. Producing the full history of one batch, including the deviation, the investigation, the released specification and the SDS revision in force at the time, takes days of assembly work. That assembly work is the real product of most quality departments, and it isn't quality work at all.
