Medical Device Raw Material Traceability Requirements

psp1234

Involved In Discussions
#1
Hi,
We are a contract manufacturer for medical device companies.
I am new at the Quality team and I see that the practice here is to report raw material (for the making of a component) lot numbers on the COC.
I have two questions, if you may:
1. Is it necessary to list ALL materials used with traceability (including glue lot number) or only the main/high risk?
2. Is it necessary to have one-one lot ratio. So, if we need two lots of raw-material-x, we would need to breakdown a finished lot to not create a situation, where two raw materials are "mixed" in our finished component lot (even though we would have traceability to both).
3. If we don't have a customer's explicit requirements for one-one raw-lots usage, is there any FDA requirement to do it?
(we are not FDA registered, only ISO-13485.):confused: :ca:

Thanks in advance,
Sue
 
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somashekar

Staff member
Super Moderator
#2
Hi Sue.
1. Is it necessary to list ALL materials used with traceability (including glue lot number) or only the main/high risk?
The traceability requirement is a risk based decision, and it is based on your product made and its intended use. So if the glue gets recognized as a material requiring traceability, it gets included.
2. Is it necessary to have one-one lot ratio. So, if we need two lots of raw-material-x, we would need to breakdown a finished lot to not create a situation, where two raw materials are "mixed" in our finished component lot (even though we would have traceability to both).
Any sort of mix will kill the purpose of traceability, if that specific material is identified as traceability required.
 

psp1234

Involved In Discussions
#3
Hi somashekar,
Thanks for your reply,
For the purpose of a possible recall, if I mix two materials in my lot, I can still identify in which lot the "bad raw material" was in. It will only increase the number of lots I recall, which is my risk (ok, and the customer's too:notme: - but customers don't dictate lot size for us, so it will be irrelevant).
And what if 100% of functionality (of raw-part) is performed? that reduces the risk altogether - can I remove traceability for a raw material (let's say an o-ring) if 100% tested?
(Is it all driving from the PFMEA risk factor?)

Thanks again,
Sue
 

somashekar

Staff member
Super Moderator
#4
if I mix two materials in my lot, I can still identify in which lot the "bad raw material" was in. It will only increase the number of lots I recall, which is my risk
Yes it is, only if you are exactly sure you can identify in which lot the "bad raw material" was in ..... meaning you have established traceability adequately.....
 

pkost

Trusted Information Resource
#5
And what if 100% of functionality (of raw-part) is performed? that reduces the risk altogether - can I remove traceability for a raw material (let's say an o-ring) if 100% tested?
(Is it all driving from the PFMEA risk factor?)

It reduces known risk, there are still the unknowns. I'd argue that even the known risk isn't reduced to 0.
 
B

BarryTaylor

#6
In general terms I agree, traceability of raw materials should be managed with a risk based approach where there is no customer specified requirement. One could argue that you may decide to take a more robust line than required by your customer.

Factors that should be included in the risk assessment are:
- the potential for, and severity of, injury to the patient or user if the material failed by failure mode "x" or by failure mode "y"
-the potential business risks if the material should fail.

these, and other factors identified in the risk assessment, should be used as input to your risk management process that may say, for example that mixing of two raw material batches has an acceptable risk profile even if it were to double the number of finished devices affected.

A word of warning, my experience suggests that too radical an approach to risk management does not sit well with regulators and their inspection teams.
 

psp1234

Involved In Discussions
#7
Thank you all!
Based on "risk analysis" only, most our materials are rather risk free. Our processing that adds the value, adds risk to the product. But I don't see any customer that will approve (or see favorably) losing resolution of raw material.
;)
I guess I will push for bigger lots at incoming...

Regards,
Sue
 
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