this post was submitted on 02 May 2026
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I was in the corporate medical industry. The only things that got handled at all in a efficient time was those required by law. Like if there was a incident in the field we had to have an initial report within a week and a corrective action within 30 days. Preventive actions were longer term, didn't have a deadline so it was not uncommon for it to go on for a year or more.
I can't give a real example for legal reason but let's a product was sold which gave electrical shocks to a patient. Within a week we had to tell the fda the cause was a faulty resistor. Within 30 days we had to correct our system, for example assign a person to test that resistor with a dmm on every device. Easy enough, give the operator who installs the resistor a dmm, update the instructions to say to measure that resistor and give a 5 minute training to said operator telling them that they have to measure it. Easy to do in 30 days and required. Now really the root cause was we didn't test for that in our multiple automated tests. The preventive solution would be update the automated testing software to check that. That has no time limit. It now becomes low priority. We did have to give an estimated time line, say within 2 years. By the time that deadline approaches most people who originally said that have left the company and new people are unaware. They submit an extension, and it's low priority again. Another 2 years go by. Now the high priority is the next product release. The old product will be discontinued so no one cares. So for 4 years and possibly several more years after it the company pays a person to manually measure a resistor. The automated test would eliminate this need, be more reliable, have documented results but wasn't implemented because it's low priority since there's no legally obligated time line.