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View Full Version : QC (Quality Control) Visual Standard for Medical Device Product


Aristo
26th June 2007, 09:33 PM
do you set up your QC visual standard (for medical product) like this?

Scratch length < 3 mm
Bubbles/dots/dents size < 0.20 x 0.20 mm;
The whole PC tube not more than 2 scratches/bubbles/dots/dents within 1 foot apart from the unaided eye; :rolleyes:

Gert Sorensen
27th June 2007, 02:25 AM
do you set up your QC visual standard (for medical product) like this?

Scratch length < 3 mm
Bubbles/dots/dents size < 0.20 x 0.20 mm;
The whole PC tube not more than 2 scratches/bubbles/dots/dents within 1 foot apart from the unaided eye; :rolleyes:

The problem, as I see it, is that you don't specify how to measure it. When you use the phrase "unaided eye" I get the feeling that it is merely a visual inspection. I, for one, am not able to see whether a given "dent" is 0.20 x 0.20 mm, especially at 1 feet (how do I measure that distance, too?). I would say that you need some sort of reference to provide a guide to what is acceptable or not.

I also wonder, do you intend to test each and every length of tubing? It is practically impossible to test all tubing that you extrude manually, and the effect of the performed testing is not going to bring you any value (at least very little). If I were you, I would go for some sort of vision control if it were economically possible. Gives better test results in the long run.

Marc
27th June 2007, 03:40 AM
Here's an example 'visual card' that may give you some ideas:

http://elsmar.com/png/Example_Visual_Card.png

Ajit Basrur
28th June 2007, 09:37 AM
do you set up your QC visual standard (for medical product) like this?

Scratch length < 3 mm
Bubbles/dots/dents size < 0.20 x 0.20 mm;
The whole PC tube not more than 2 scratches/bubbles/dots/dents within 1 foot apart from the unaided eye; :rolleyes:

Aristo,

Yes, usually these type of specs are defined by the R & D unit or the design unit who build the design.

DanteCaspian
11th February 2009, 05:27 PM
Your format looks good.
We use something similar, but again, you need some quick and easy way of dimensional comparison.
Another example that may be of use.
Print the attached via laser printer on transparency film; useful for overlaying on the part in question.

Nissim Shaked
13th February 2009, 08:38 AM
Another good method to make such an inspection is to use Scratch and Dig samples that were made according with MIL-O-13830
For more info please use the attached link
http://www.davidsonoptronics.com/D-667.htm