We currently are ISO 13485 and manufacture class I and Class II medical devices.
We perform incoming inspection of raw materials using ANSI Z1.4. We also have implemented a basic skip lot program.
My question is related to common commodity items such as screws, washers, nuts, bolts, couplings, adapters, hose clamps, tubing, etc. that can be purchased nearly anywhere. All of these items would be caught in the manufacturing process if they were defective and we have never had any failures from our incoming inspections.
Does any think its problematic to receive them directly into inventory without a receiving inspection? I do not see any value in inspecting numerous samples from a lot of commodity items each time they arrive.
Can anyone else give me an idea of how they handle basic commodity items and the incoming inspection process. Again, none of these items are critical to our product and are extremely low risk parts.
Any thoughts?
We perform incoming inspection of raw materials using ANSI Z1.4. We also have implemented a basic skip lot program.
My question is related to common commodity items such as screws, washers, nuts, bolts, couplings, adapters, hose clamps, tubing, etc. that can be purchased nearly anywhere. All of these items would be caught in the manufacturing process if they were defective and we have never had any failures from our incoming inspections.
Does any think its problematic to receive them directly into inventory without a receiving inspection? I do not see any value in inspecting numerous samples from a lot of commodity items each time they arrive.
Can anyone else give me an idea of how they handle basic commodity items and the incoming inspection process. Again, none of these items are critical to our product and are extremely low risk parts.
Any thoughts?
