Parts tracing in medical device (ISO13485, MDSAP, FDA, MDR)

[evan_kim90]

Hi,

I have a basic question regarding parts tracing for medical devices.

Is every part required to be tracked in the batch record? (ex., screw, small plastic parts inside)
Or only risky parts can be recorded in the batch record? (ex., PCB, Sub-Assembly)

If we have to write down all single parts in the batch record,. Do we have any statement from standard such as ISO13485, MDSAP, FDA and MDR?)

Thank you in advance for your help.

 

[Parul Chansoria]

Hi @evan_kim90, it is certainly good to question what should or should not be included in every document that one creates for a medical device. In this case, it is to be noted that batch records are meant for facilitating traceability, and in general as the rule of thumb whenever it comes to traceability, the more the details the better it is. Hence, I would recommend to mention every single detail in there. This will also be very useful, due to the following:

A thorough Device History Record (DHR)
You will end up making a comprehensive DHR when you pay attention on every single detail and ensure to put that in, this will allow you to know exactly what goes in to your product to make it.

Effective root cause analysis
With every information at your disposal, whenever there is a product issue or complaint in the field you can pin point to a problem very easily.

Comprehensive FMEA
Your design FMEA will be comprehensive and whenever you plan to make any design changes you will be aware of every impact that you need to take into account proactively.

Thorough documentation and good traceability go a long way in maintaining continued compliance and is certainly expected as per ISO 13485, MDSAP, FDA and MDR. While the regulations don't explicitly call out what part should be included or excluded, as that depends on a product, these regulations expect that a company has DHRs that include or refer to the production and process control records, including batch records. While one may think that having a batch record with high level information is enough, but in case there is a future issue a thorough batch record serves many purposes.

Hope this helps.
Best,
Parul Chansoria

 

[Tidge]

Nothing should be in a finished device except material on the Device Master Record; the DMR should include a list of all components of a finished device. The DHR for an individual (or batch of) finished goods should identify the DMR used, with any extra traceability as required.

It is certainly possible to use "open stock" items (I'm thinking cable ties) that may not have a specific count, or floor stock compounds that have some variety in amount (marking compounds) but even such things should be somewhat specified on the DMR.

I would absolutely want to know that each device with fasteners (inside or otherwise) had all of the required ones within it.

 

[evan_kim90]

Hi @evan_kim90, it is certainly good to question what should or should not be included in every document that one creates for a medical device. In this case, it is to be noted that batch records are meant for facilitating traceability, and in general as the rule of thumb whenever it comes to traceability, the more the details the better it is. Hence, I would recommend to mention every single detail in there. This will also be very useful, due to the following:

A thorough Device History Record (DHR)
You will end up making a comprehensive DHR when you pay attention on every single detail and ensure to put that in, this will allow you to know exactly what goes in to your product to make it.

Effective root cause analysis
With every information at your disposal, whenever there is a product issue or complaint in the field you can pin point to a problem very easily.

Comprehensive FMEA
Your design FMEA will be comprehensive and whenever you plan to make any design changes you will be aware of every impact that you need to take into account proactively.

Thorough documentation and good traceability go a long way in maintaining continued compliance and is certainly expected as per ISO 13485, MDSAP, FDA and MDR. While the regulations don't explicitly call out what part should be included or excluded, as that depends on a product, these regulations expect that a company has DHRs that include or refer to the production and process control records, including batch records. While one may think that having a batch record with high level information is enough, but in case there is a future issue a thorough batch record serves many purposes.

Hope this helps.
Best,
Parul Chansoria

Thanks for the kind explanation. It is giving me way of understanding documentation. Again Thanks a lot.

 

[evan_kim90]

Nothing should be in a finished device except material on the Device Master Record; the DMR should include a list of all components of a finished device. The DHR for an individual (or batch of) finished goods should identify the DMR used, with any extra traceability as required.

It is certainly possible to use "open stock" items (I'm thinking cable ties) that may not have a specific count, or floor stock compounds that have some variety in amount (marking compounds) but even such things should be somewhat specified on the DMR.

I would absolutely want to know that each device with fasteners (inside or otherwise) had all of the required ones within it.

Thanks for the kind explanation. It is really hard to put everything in DMR but we should do and I will try. Thanks for advice.