Recording Scrap - Problems in the Medical Device Manufacturing Sector

E

excellerator

#1
As everyone in the Medical Device manufacturing sector knows keeping a record of scrap parts during production is almost impossible when human interaction is involved. Doesn't it seem unfair to make suppliers responsible for all in-process pieces be accounted for if the final count of what was sent to the customer is correct.
 
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ScottK

Not out of the crisis
Staff member
Super Moderator
#2
Re: Recording Scrap

As everyone in the Medical Device manufacturing sector knows keeping a record of scrap parts during production is almost impossible when human interaction is involved. Doesn't it seem unfair to make suppliers responsible for all in-process pieces be accounted for if the final count of what was sent to the customer is correct.
Is there a standard that requires this? Or is it a customer requirement?
I make components for medical devices and have no such requirement for any of these parts, even though they are custom parts.

And did you mean to put this in the controversial forum?
 
T

True Position

#3
Re: Recording Scrap

As everyone in the Medical Device manufacturing sector knows keeping a record of scrap parts during production is almost impossible when human interaction is involved. Doesn't it seem unfair to make suppliers responsible for all in-process pieces be accounted for if the final count of what was sent to the customer is correct.
If you are required to track every produced part from incoming stock to outgoing material to avoid non-conforming material making it to the customer you will need to include that into the item cost. If this is a change from a customer request the ability to re-quote. If you've already accepted the quote with this condition they assumed you built this cost in.
 
E

excellerator

#4
By no means did I intend for this to be a controversial thread. I had a customer audit and in the 21 CFR 820 it states that the DHR ( Device History Record ) SHALL include the following information.

Dates of manufacture

Quantity manufactured

Quantity released for distribution

Acceptance records which demonstrate device was made in accordance with the DMR ( Device Master Record )
 
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