I've just gone through two medical device product listing audits in the last week. These two products have critical components defined for them. When I was asked how incoming inspection is handled for critical components, I was thrown for a bit of loop.
The way my quality system is set up, any catalog, off-the-shelf component is inspected in the following way: 1) it has its part number verified against the packing list and the purchase order 2) it is visually examined for any physical damage to the part. That's it. A majority of the critical components for the two medical devices fall into this category. Should I be doing more than this as they are "critical components"? I felt like I had to pull out some test reports or other data to appease the auditor. (BTW, the receiving clerk stamps the packing list received, and initials and dates it as proof of inspection/verification.)
I would be interested in finding out what others are doing or if there are any suggestions.
Thanks!
The way my quality system is set up, any catalog, off-the-shelf component is inspected in the following way: 1) it has its part number verified against the packing list and the purchase order 2) it is visually examined for any physical damage to the part. That's it. A majority of the critical components for the two medical devices fall into this category. Should I be doing more than this as they are "critical components"? I felt like I had to pull out some test reports or other data to appease the auditor. (BTW, the receiving clerk stamps the packing list received, and initials and dates it as proof of inspection/verification.)
I would be interested in finding out what others are doing or if there are any suggestions.
Thanks!
