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2 days agoWe’re making medical product, and are 13485 and 9001 regulated. It’s concerning the number of times I’ve had to fight with supervisors because I deemed it important to loop Quality in on my changes and made a task take longer and they didn’t agree with the choice.
Is your site currently losing about 1/3 of it’s area to an outside company who bought a division and the apparently completely sane plan is to seperate off that area and duplicate prexisting structures (HR, Warehouse, Quality) for the new company?
But yeah Patient safety comes first. As long as the lines don’t go down. Or too slow. Or don’t get stopped from speeding up at the planned rate.
For a business where the FDA WILL show up unannounced and audit, we sure do love to push back against quality.