QC (Quality Control) Visual Standard for Medical Device Product

A

Aristo

#1
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:
 
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Gert Sorensen

#2
Re: Do you set up your QC visual standard for medical product like this?

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.
 

Ajit Basrur

Staff member
Admin
#4
Re: QC Visual Standard for Medical Product

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

Quite Involved in Discussions
#5
Re: QC Visual Standard for Medical Product

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.
 

Attachments

M

marti1209

#7
Re: Do you set up your QC visual standard for medical product like this?

I'm trying to find an SOP I can use as a model to create create my own SOP to control visual samples and templates for Receiving Inspection purposes.
 
J

Julie O

#8
Is that really a visual standard? I think of a visual standard as sort of a last resort, when you need to inspect something that cannot be measured, or that does not need to be measured (i.e., the outcome is a simple yes/no and easily determined by the human eye).
 
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