Free Republic
Browse · Search
General/Chat
Topics · Post Article

To: reed13k; Radix
...just had to deal with complaints/MDRs too much in my line of work....(20+ years of med device)

After spending the end of my engineering career packing up manufacturing plants for shipment I totally feel your pain.

Kindest evaluation I have of Far Eastern manufacturing processes is the fabrication is okay but Quality Control sucks.

Particularly electronics. (Unless you're an Apple supplier and are forced to throw away your junk before you ship...)

(I'd hazard a guess that your complaints/MDRs amounted to 25 - 30 percent of available stock....)

459 posted on 02/07/2022 6:24:29 AM PST by Unrepentant VN Vet (Whom shall I send, and who will go for us? And I said, Here am I; send me.)
[ Post Reply | Private Reply | To 378 | View Replies ]


To: Unrepentant VN Vet

Places I worked it wasn’t that bad for most product as we were higher end and used a lot US local production.

The lower end stuff that wasn’t accepted as minimal US level anymore was all shipped overseas. Stuff like a .5Tesla MRI where today the standard is 1.5Tesla, 1 to 8 detector CTs where today the standard is 64, etc was all shipped out.

Where I did see an issue was in low end medical stuff like manual wheelchairs. Had a factory we pulled up to one time and before I got out of the car I told the SQE that reported to me that I could already see 5 issues. He looked at me oddly and then I listed them off. nonconforming not labeled; tooling in the weather; mixed nonconforming, tooling, and raw product; product not labeled....he stopped me at 5 to be honest. Needless to say the inspection did NOT make the owner happy. I flatly told him that if the FDA ever showed up they would cut their import license the same day....no bothering with 483s, warning letters or CDs with overseas suppliers.

Outside of that low end stuff though the vast majority of our issues were design - software, stackups, not really knowing the transfer equations between components, parts, subsystems, and system. maybe 1/3 at most was supplier or internal manufacturing usually associated with single lots or testing not being able to detect something.


618 posted on 02/07/2022 6:32:48 PM PST by reed13k (For evil to triumph it is only necessary that good men do nothing)
[ Post Reply | Private Reply | To 459 | View Replies ]

Free Republic
Browse · Search
General/Chat
Topics · Post Article


FreeRepublic, LLC, PO BOX 9771, FRESNO, CA 93794
FreeRepublic.com is powered by software copyright 2000-2008 John Robinson