If we have an incoming material used in production of device fail inspection but accept under deviation, how do we have the DHR reflect this? The materials we accept under deviation are usually cosmetic defects and cover a few weeks to months of production, thus many lots.

As the batch control records (travellors) don't have a place to note the material was under deviation, does each lot have to have all this info attached as part of DHR? If you pulled just the DHR (suppose product failed in use) you would not not know. But at same time, if you did trace of all materials used in lot, then you could locate deviation.

I'm also wondering if FDA spells this out anywhere.

Thank you

If we have an incoming material used in production of device fail inspection but accept under deviation, how do we have the DHR reflect this? The materials we accept under deviation are usually cosmetic defects and cover a few weeks to months of production, thus many lots.

As the batch control records (travellors) don't have a place to note the material was under deviation, does each lot have to have all this info attached as part of DHR? If you pulled just the DHR (suppose product failed in use) you would not not know. But at same time, if you did trace of all materials used in lot, then you could locate deviation.

I'm also wondering if FDA spells this out anywhere.

Thank youIt's in 21cfr820.90, nonconforming product. Just where you would expect it to be.

If we have an incoming material used in production of device fail inspection but accept under deviation, how do we have the DHR reflect this? The materials we accept under deviation are usually cosmetic defects and cover a few weeks to months of production, thus many lots.

As the batch control records (travellors) don't have a place to note the material was under deviation, does each lot have to have all this info attached as part of DHR? If you pulled just the DHR (suppose product failed in use) you would not not know. But at same time, if you did trace of all materials used in lot, then you could locate deviation.

I'm also wondering if FDA spells this out anywhere.

Thank you

I know of companies that include a copy of the deviation approval in the DHR. This seemed to work well for them. Should they ever need to reference the DHR, they would find everything that applied to that particular lot inside.

This is just one example, but you should do whatever works best for your company. :agree1:

Hope this helps. :)

I would suggest to make a manual reference to the deviation (number?) on each applicable DHR.
Than look into the possibility to change your DHR and include a designated field where if applicable a deviation could be registered.
It might also be wise to attach a list or spreadsheet to the deviation containing all lots involved to ensure traceability of the deviation.

Regards,
Jeroen

I have a seperate section to refer deviations, if any, applicable to that batch in the DHR template.

With this, it provides traceability as well the releasing authority has a hold on the batch release vis-a-vis the devaitions.