Identifying Inspection Level for Critical Components - Medical Devices

RCW

Quite Involved in Discussions
#1
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!
 
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G

gholland

#2
For my company we don't identify a part as Critical, we identify dimensions or features that are Critical on the part and then inspect them on a sampling plan. Sometimes we will 100% inspect the flagged Critical items on the first few lots of a new item.

I think identifying <what> on the part is Critical and then inspecting that particular feature/dimension is the proper way to go. Not everything on a 'Critical' part is Critical.

:2cents:
 
M

MIREGMGR

#3
I would agree that your engineers should be identifying part characteristics or performance parameters that are critical-product-functionality-determinative...certainly for FDA Class II and III devices. It's important that they be required to identify particular characteristics or parameters so that (1) you and they can agree on inspectability, methods and acceptance/rejection values, and (2) you can verify that in fact you're inspecting the characteristics that matter.

I once heard a story of a "critical" component being inspected very carefully over a number of months for characteristics A, B and C, only to have it revealed later that the critical characteristics actually were D and E.

I also know of past technical issues involving "catalog, off-the-shelf components" that didn't meet specs...or sometimes, when investigated, didn't have specs other than nominals.
 

RCW

Quite Involved in Discussions
#4
What has been posted here so far reminds me of another angle to this isssue.

One critical component listing had a very thorough description of the item (ex. power cord - 3 conductor, 18 AWG, minimum 120VAC rating, 10A, etc) and then it also included a specific part number. The other critical component listing just had the description, (see ex. above) and no part number. When my purchasing department goes out to buy parts, they do so with a specific part number. They do not go to their suppliers, give them the description listed, and what comes in "should" meet that description. I think this is part of what is confusing me. I'm inspecting the part against a part number, not necessarily against a description.
 
M

MIREGMGR

#5
If the products you make in fact need to have critical components defined, then it doesn't sound to me as if your quality system...and in particular, management's understanding of what engineering needs to do to support the sourcing process...is effective. Certainly you aren't going to solve the problem by inspecting to see that incoming parts have the right source P/N on the paperwork.
 
G

gholland

#6
I think with Miregmgr and I are saying is that what you are inspecting isn't what is 'critical' about the component. If a part is critical and I'm an auditor, I'm going to ask you 'ok show me what makes the part critical and then show me how you prove the part meets the requirements.'

If a power cord is what you are looking at then you need to ensure that the cord is going to do what the cord is supposed to do. That means inspecting for things that ensure quality of the part and compliance to your requirements. If you don't know what the requirements of the cord are, how do you know what to inspect for and what is critical?
 
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