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Medical Device Tracking Sampling Plan using MIL-STD-105E

#1
Hi - I am trying to develop a Medical Device Tracking Sampling Plan using MIL-STD-105E. This is being done to comply with FDA regulations of being able to audit your records to whom you sold to and to whom your distributors sold to and down the line for the life of the product.

In this case, 2 of our products contain a unique serial number and one product is produced by quantity of a single lot number.

My question is regarding the unique serial number product is what constitutes a lot for sampling: a) the total amount sold, b) the total amount of distributors or c) the quantity each distributor purchased?

Thanks
 

Jim Wynne

Super Moderator
#2
If you could explain a bit more about what you're trying to do it would help. It doesn't sound like a lot sampling plan like 105E will be appropriate.
 
#3
Example would be you made 100,000 medical devices over the year each bearing a unique serial number, which were sold to 200 distributors. It is a requirement that in the event of a recall that the device manufacturer can know where that particular device resides so they may call it back. We audit our system to do this. Currently we query a sampling of what was sold to each distributor.

I recently read where a recognized statistical sampling plan such as MIL STD 105E should be used. I agree with you as it would not be a plan I would use for this. If one did want to use it though, I am trying to come to terms with what would be the "lot" to draw the sampling plan from, the 100,000 unique devices, the 200 distributors, or going into the sales records for each distributor and using the total amount they purchased as the lot.

Thanks for the reply.
 
M

MIREGMGR

#4
I wouldn't solve this problem using a "sampling" approach. My reading of the rules is that if traceability is required, every unit must be traceable.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#5
I wouldn't solve this problem using a "sampling" approach. My reading of the rules is that if traceability is required, every unit must be traceable.
I don't think there's any question about that.

However, I think the OP is saying that for competence auditing of their tracing / recall system, running the tracing exercise for each and every unit out there would be impractical. Just like big companies only review a sample of R&D projects in internal D&D audits.

My personal opinion is that for this purpose several sorts of sampling approaches (i.e. what is the "lot" to sample from) could be justified. The important thing is to make sure the justification is solid, and document it in detail so that it can be reviewed and adjusted in the future, if necessary.

Cheers,
Ronen.
 
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