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Acceptance Criteria at Design Verification

S

Skamikaze

#1
Hi everybody,

I am working in a company which manufactures grafts according to customers specifications. We have manufacturing and inspection processes for the products. Depending on the product, manufacturing processes perform very differently on a lot to lot basis. There might be a lot with 90% yield followed by one with 50% yield. Scrap reasons might be due to dimensions out of specification or due to visual inspection criteria.

How could you perform Design Verification with this variable yield? What would be the acceptance criteria? Applying confidence level / passed parts would lead to a failed DV. All specified features are inspected on every part in serial production.

Thanks.
 
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yodon

Staff member
Super Moderator
#2
What are you "designing"? Sounds to me that you're describing more of a manufacturing process rather than a design.

I don't see how yield correlates to design verification. For example, if I have designed a device, I can verify the design. When it transitions to production, I may have really poor control and only a % passes final acceptance test. That has no bearing on my design verification, though.
 
S

Skamikaze

#3
You are right. We receive a drawing from our customers were the part is described with technical terms like dimensions, material properties etc. We manufacture the part with our processes and inspect it according the to be inspected dimensions on the specification. Our customer brings the parts to the market.
As the FDA rates us as a finished device manufacturer. 21 CFR 820.30 states that all class III manufactures have to follow Design Control, which means also that Design Verification applies.
Our current understanding is, that the dimensions serve as our Design Input. This means we have to compare our Design Outputs (manufactured dimensions) with the specified dimensions (Design Inputs).
 
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