FDA 21 CFR 820.90 - Nonconformance and Device History, and Rework Records

[dmcgriff8 - 2006]

(2) Each manufacturer shall establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications. Rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, shall be documented in the DHR.
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Please explain this section from FDA 21 CFR 820.90. Am I suppose to place a copy of all rework activity in the Device History Record resulting from all nonconformace parts from vendors that are rework inhouse and used on each Device. example... I receive 20 nonconformance parts. My company reworks the parts to bring in spec. I track each of the 20 parts until it place on a device. I place copies of each nonconformace in the Device History Record.

 

[Al Rosen]

(2) Each manufacturer shall establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications. Rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, shall be documented in the DHR.
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Please explain this section from FDA 21 CFR 820.90. Am I suppose to place a copy of all rework activity in the Device History Record resulting from all nonconformace parts from vendors that are rework inhouse and used on each Device. example... I receive 20 nonconformance parts. My company reworks the parts to bring in spec. I track each of the 20 parts until it place on a device. I place copies of each nonconformace in the Device History Record.

Yes, or somehow identify where the records for the rework are. The DHR does not have to be a separate file or collection of records.

 

[Watchwait]

Yes, or somehow identify where the records for the rework are. The DHR does not have to be a separate file or collection of records.

Al, I just came across your comment about a DHR not having to be a separate file or collection of records. If not that, are you referring to some sort of index that would "point" to the actual records themselves? I know this approach holds true on the DMR but I've never seen it applied to the DHR. Any examples you can think of that might illustrate when this might be a better approach that the "traditional" DHR format? Thanks!

 

[Al Rosen]

Al, I just came across your comment about a DHR not having to be a separate file or collection of records. If not that, are you referring to some sort of index that would "point" to the actual records themselves? I know this approach holds true on the DMR but I've never seen it applied to the DHR. Any examples you can think of that might illustrate when this might be a better approach that the "traditional" DHR format? Thanks!

Incoming Inspection Records, In-process Inspection Records, Final Inspection Records and Servicing Records might be located in different places.

 

[Watchwait]

Thanks Al! So obvious I missed the forest for the trees!