820.90 Nonconforming product - Rework

Tom Penn

Registered
Hello folks,

We're currently grappling with a challenge related to fulfilling the requirements of 21 CFR 820.90, specifically regarding the inclusion of records of performed rework in the Device History Record (DHR) for our medical devices.

In our manufacturing process, nonconforming products are often identified during the incoming inspection. These nonconformities sometimes involve minor issues like deburring, which we address before storing the parts, and a Nonconformance Report (NCR) is raised.

Typically, these corrected parts are further assembled into sub-assemblies or larger assemblies. These assemblies are then placed into interim storage before being incorporated into the final medical device.

Our concern lies in tracking these rework records from the point of incoming inspection all the way through to the final assembly, ensuring that they are properly documented in the DHR. We're striving for a seamless and compliant process but are looking for practical solutions to make this happen.

Has anyone encountered a similar challenge or devised a system to effectively track rework records and ensure they are seamlessly integrated into the DHR throughout this multi-stage manufacturing process? Any insights or best practices would be greatly appreciated!
 

yodon

Leader
Super Moderator
Not seeing this post get any lovin' so I guess I'll maybe get the ball rolling. First, the barrage of questions.

Given that everything is risk driven, what's the risk of this type of rework? Where do you document that? Do you do 100% inspection before and after rework (i.e., to segregate what has to be reworked and then afterwards to confirm the reworked items are all ok)? Do you require traceability back to those reworked components?

If you need traceability to the reworked components (-v- the non-reworked ones), maybe split the lot into non-reworked and reworked (with separate lot IDs). Part of the receiving acceptance for the rework lot is a record of the rework done and subsequent acceptance.

If you don't require that level of traceability, just capturing the rework record with the receiving record is probably sufficient.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Parts arrive and are inspected. Parts that pass inspection are moved into the acceptable section of the warehouse fir for use. Rejected parts are identified and contained. A review may be performed to make these parts usable. There are other outcomes like a return to vendor, use as is or scrap. Reworking the parts can be identified on its own record with lots # information. Once reworked they should be considered acceptable.

From your comment are you asking s there is a difference between parts that arrived as acceptable and those reworked to be acceptable and traceability? I would suggest that your subassembly batch records document if they contain parts that were reworked and under which rework order. When those subs are used in the final product build include a copy of the subassembly batch record within the final DHR.

If you contend that the rework process is not as robust as the conforming product quality received by that vendor thats another issue.
 

FRA 2 FDA

Involved In Discussions
This is a good question for me too. We just launched and so three weeks ago I assembled and reviewed my first DHR and released product to market. I simply placed a copy of every NCR report, exception report and deviation report related to anything (all assemblies that went into the final products) in the DHR folder. Maybe this is overkill as the inspection reports that go into the DHR reference any related NCRs, exceptions and deviations which could then just be referenced in their own storage locations but I wanted to err on the side of caution.
 

Tom Penn

Registered
Hey Yodon and Ed,
thanks for your response and input. When it comes to parts with batch records or serial numbers, it's no issue showing traceability. But our problem lies with parts that don't have them. Since we do a 100% verification (inspection) after rework, I'll go with Ed's suggestion and consider them acceptable. So, I won't attach a final rework or NCR record to the device's final DHR.
 
Top Bottom