Regulations for Yield Reporting and Evaluation Upon Lot Completion

A

Audit Consultant

#1
After requesting a our medical device contract manufacturer (Class II devices) to provide yield reports with each lot sent to us the Plant Manager is claiming providing yield reports monthly should be satisfactory.

The reason I need this information is to understand if we started with an order and provided components for 250 devices to be produced and only received 220. I need to be able to evaluate the reason for the 30 failures and make a decision as to if there could be other issues with the lot as well potentially improve the process for the next lot.

Do you know of any regulations or requirments under FDA, GMP's, ISO 13485 or other that I can use for my pending discussion that require yield reporting IMMEDIATELY upon lot completion for a manufacturer? This is other than individual business requirements or ISO requirements that require evaluation and reporting under CAPA. Thank you.
 
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v9991

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#2
Re: Regulations for Yield Reporting and Evaluation Upon Lot Completion?

from regulatory perspective [ Pharma ]..,
the yield reconciliation is part of the manufacturing controls..

and the compliance is summarized in yearly report. viz.,changes to manufacturing process [related deviations/investigation]; along with respective validations where applicable.

for the supplier control, this is part of initial assessment [audits, quality agreements etc.,] and continuous monitoring [rejections,investgations...].

in short...
your objective of getting an yield update for every batch[supplied to your firm] needs to be handled based on your 'commercial agreement' with the supplier, by making it part of the CofA[Certificate of Analysis];

next level is where you might want the supplier to share the RCA/investigation details to know the impact...what will you do if the investigations are "under-way/not-conclusive"...?
essentially the time-frequency specified for concluding the investigations, should drive the frequency of periodic update which you should expect from the vendor...i will give one more try to search for specific reference so frequency of update for investigations etc..,

hope that helps.

valiveti.
 
Last edited:
J

jscholen

#3
The regulations are pretty broad in its application to your circumstance. Components yeilds are a form of quality data which should be inputs into your quality system, but how and when you gather that data is up to you...as long as it seems "adequate".

To comment on the lot by lot data versus monthly data, I would ask how many lots are you processing per month. If its only 1, 2 or 3 lots, I might side with the PM, but if its 4+, where you could potentially plot a trend, then I would argue for lot by lot data.

Like valiveti said, your supplier agreement should spell out what the expectations are...if you don't have verbage about it, then your going to have to negotiate or find a new supplier.

Other things to consider, are you getting back the failed components to investigate? is their inspection of the components the same as yours?.....you might want to change your outgoing inspection criteria to their incoming or inprocess inspection to ensure you guys are looking at the same thing...

good luck.
 
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