The load on the inspector
Swiss-turned parts are small, and there are a lot of them. An inspector may look at a few thousand pieces in a week, one at a time under magnification. By the afternoon the eyes are tired and the burr that was easy to see in the morning is harder to catch.
Nobody wants to add more people to stare at tiny parts. A camera station does not get tired, and it looks at each part under the same light. VZSOR uses that to give the person a second look at the ones that seem off, so they can spend their attention there.
Records tied to lot and serial
Every inspection stores the photo, a heatmap of anything flagged, the PASS or FAIL result, the operator, the lot and serial, and the time. You can export the log to CSV. If a customer asks what was checked on a lot, you can show them the images.
These records are the sort of evidence that may support your device history documentation. They do not replace your quality system. How they fit in your files is a decision for your quality manager and your customer, so raise it with them early in the pilot.
Validation expectations
Many medical device customers expect any tool used in production to be qualified, often through IQ, OQ and PQ protocols. A VZSOR pilot does not provide that. It is a 30 to 60 day trial on one part number to see whether the station is useful on your parts.
If the pilot goes well and you want to put a station into production, the qualification work is something you and your customer would need to plan. Ask your customer early what they would expect. We would rather you know that now than discover it after the pilot.
Honest about small parts
VZSOR has been validated on one part: a 2 inch by 2 inch aluminum L-bracket with a mill finish. It has not been validated on small turned parts, on stainless or titanium, or on polished or passivated surfaces. Those are common in medical work, and each may behave differently.
The camera sees an area of about 100 to 120 mm. Very small parts take fixturing to hold and light properly, and round parts reflect light in ways flat parts do not. A pilot is the way to find out whether your part works. It may not.
Good fit, poor fit
Good fit
- Small machined parts with a cosmetic reject reason and a lot or serial number on each
- Shops that inspect every piece by hand and want a second look and a photo record
- Parts that can sit stable in a simple fixture under the camera
- Customers open to a pilot on one part number with the right expectations
Poor fit
- Work where the customer requires a qualified inspection tool from day one
- Parts whose critical features are dimensional, such as thread or bore size
- Highly reflective or curved surfaces that are hard to light evenly
- Parts too small or too awkward to hold still under the camera
Limits, stated plainly
- Validated on one part only: a 2 inch by 2 inch mill-finish aluminum L-bracket.
- Small turned parts, stainless, titanium and polished surfaces are not yet validated.
- A pilot does not provide IQ, OQ or PQ validation. Your customer may expect it.
- It does not measure dimensions, and it is not final quality sign-off.
- Field of view is about 100 to 120 mm, and very small parts need fixturing.