Quality Digest

We are a distributor and have components manufactured for us. We do inspect a portion of items as they come in. During our surveillance audit, we received a major in section 8.2.4. The CAR stated, "Final inspections on the Production Work Order #403 for Ultra Pins (EPL) require, "Verify diameters 10% per size". There was no objective evidence that the diameter characteristic or the required sample size were measured or that the inspection record provided evidence of conformity to those requirements. Observation of the measurement of the diameter of 3 pieces pulled randomly from finished stock found that 1 of the 3 pieces was out of specification."

We inspect the parts, but didn't document the findings. We state that if the parts are acceptable we put them into stock.

From what the auditor is stating is that we have to measure and document everything.

We cannot afford to inspect everything that comes in nor can we require inspection reports on everything from our suppliers.

We thought we interpreted the standard correctly but apparently we didn't.

Does anyone have any suggestions for how to handle this?

Thanks