21 CFR 820.90 - Documenting rework and reevaluation in DHR

[Cybel]

Hi, we are European manufacturer of low-risk medical devices, we sell them in USA as well.
During production, it is possible that some units are temporarily discarded as defective (for physiological and expected defects): they are reworked according internal SOPs and they return in the LOT, where they are 100% controlled in several production steps. The reworking activity can be performed at any step of the production process (depending on the type of detected defect), and until the device is not labeled with its S/N, we are not able to keep traceability of the reworked units in the LOT.
In last 10 years we’ve received three FDA inspections and inspectors always accepted that in the DHR we indicate that a certain quantity of units of that lot has been reworked. For example, in the DHR I state something like:
"70 units of the LOT XYZ (which counts 20 000 units) have been reworked..."
and I refer to a specific Non Conformity Report.

However, I find some difficulties with this, I explain through an example:
1) We need some days to produce 20 000 units of the LOT XYZ and we start shipping the units before the complete quantity is produced, so I write DHRs for groups of Serial Numbers. So, for example there is:
- DHR 1 for S/N 0001-5000 shipped on Monday
- DHR 2 for S/N 5001-10000 shipped on Tuesday
- DHR 3 for S/N 10001-15000 shipped on Wednesday
- DHR 4 for S/N 15001-20000 shipped on Thursday

From production report I know that on Monday we have produced 9.000 units and that 30 units have been reworked before receiving their serial number, so I write in DHR 1 that 30 units (out of 9000) have been reworked, but actually, because on Monday I ship only 5000 units, these 30 reworked units may not be included in the shipping of Monday.

Then, I know that on Tuesday other 2000 units have been produced and other 40 units have been reworked, so I write in DHR 2 that 70 units (30 of Monday + 40 of Tuesday) (out of 11000) have been reworked, but actually 30 reworked units may were already included in the shipping of Monday (or all the 70 reworked units may be included on the next shipping of Wednesday).

21 CFR 820.90 asks to record reworking in DHR, but I’m not sure how the way I do this makes sense.


2) I have to produce partial Non Conformity reports to which make reference in each DHR. I produce tens of DHRs each day and the work is huge, and, most important thing, it is not useful to us: we don’t need partial NC Reports, considering that defective units are under control in real time during production and that a unique and complete NC report per LOT is much more meaningful.

I’m looking for similar experiences with reworking activities and records, because I really would like to make the process smoother and records useful.
Any suggestion is really appreciated!

 

[indubioush]

Some things seem strange to me.
Why are you serializing a low risk device?
Why are your lot sizes so big? What is the benefit? How is the first serial set homogeneous with the last serial set?
Does the serialization help you with traceability? Doesn't seem like it.

 

[Zero_yield]

I would agree with indubioush's comments, but I'll try to help with one point: Most of our processes that allow rework call it out explicitly in the relevant procedure.

For example, we have a cleaning process for parts. The procedure states that parts can be recleaned up to X number of times per the validation. We don't write nonconformances for reprocessing through the cleaning operation (unless there was actually a nonconformance), because the cleaning operation explains how to document recleaning. We just document it on the DHR and move on.

Similarly, we have a process where labels are printed. If the technician notices a smudge or partial print while printing a batch, the technician is allowed to just discard the subpar label and print a new one. If a label has to be reprinted further down the line, there's a reprinting process where a new label is printed, verified, and the previous label is verified as destroyed. All of this is documented on a controlled form which accompanies the DHR. We don't write nonconformances for reprinting a label in this way; the controlled form serves as documentation of the rework.

Whenever rework is needed that isn't explicitly allowed per procedure, we open a nonconformance to document the rework activities.

 

[Cybel]

Thank you both for your inputs.

It is mainly for ensuring identification from the market: we want to know that a certain device, identified with a S/N, has been delivered to a certain customer. This is for several reasons, one of them is related to counterfeit medical devices.

Why are your lot sizes so big? What is the benefit? How is the first serial set homogeneous with the last serial set?

Well, we may have lots smaller than these. Our product has basically one critical component, and we receive it from our supplier in big lots. We want to keep traceability of this component in our production lot.
So, if we receive the critical component in a lot of 20.000 units and we receive an order from one customer of 20.000 units, we produce and ship a unique lot. In this case, components, manufacturing settings, labels, IFUs, packaging are the same.
More often, it happens that we "split" the lot of the critical component in several production lots that may have different settings, labels, IFUs and packaging depending on the customer/the destination country.

Does the serialization help you with traceability? Doesn't seem like it.

Not with traceability, but with identification it does.

Whenever rework is needed that isn't explicitly allowed per procedure, we open a nonconformance to document the rework activities.

Zero_yield, this is basically what we were used to do before our first FDA inspection: we opened a non conformance when rework activities were not "standard" activities, and we documented it in the DHR. But, during that audit, the auditor asked to improve our procedure because, she said, also "standard" (i.e. allowed by procedures) reworking and re-evaluation activities shall be documented in the DHR.

For example, we have a cleaning process for parts. The procedure states that parts can be recleaned up to X number of times per the validation. We don't write nonconformances for reprocessing through the cleaning operation (unless there was actually a nonconformance), because the cleaning operation explains how to document recleaning. We just document it on the DHR and move on.

So you don't open non conformance for this but, however, you document this "standard" re-cleaning in the DHR, is it so? May I ask you how you document it on the DHR?

 

[Zero_yield]

There's three methods I can think of for documenting reprocessing we use.

One is like the retyping I mentioned above. A separate controlled form is printed where the reprocessing is captured and accompanies the DHR.

For one process, it can be performed up to two times. The DHR has a location for documenting Process A. It then has a section beside it "Reprocessing Process A" with an N/A checkbox available (since the majority of product is only processed once). Built into the DHR, there's the option to reprocess the batch, and that's reflected in the relevant procedures and documentation.

For the recleaning I was mentioning early, that's on a product line where the majority of the documentation is electronic within our ERP system. In this case, a supervisor or similar adds an additional "cleaning" router step to the electronic DHR, allowing technicians to document the recleaning. This is also documented in a comment on the physical traveler that moves with the batch, is retained, and is reviewed before final release.

We have several different processes that have some sort of "standard" reprocessing, but I think all of them would fall into one of those categories. Either there's a specific controlled document for that operation's reprocessing, it's baked into the DHR, or it's captured electronically by adding a router step.

 

[indubioush]

It is mainly for ensuring identification from the market: we want to know that a certain device, identified with a S/N, has been delivered to a certain customer. This is for several reasons, one of them is related to counterfeit medical devices.

Can you explain further?

I don't see the benefit of having a giant lot with partial shipments. You could possibly be out of compliance with the below requirement:

(d) Final acceptance activities. Each manufacturer shall establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria. Finished devices shall be held in quarantine or otherwise adequately controlled until released. Finished devices shall not be released for distribution until:....

Just because you have one big lot of the critical component does not mean you have to have one big lot of the device. The traceability will still be there. I would suggest that you either wait until all the units in the lot are completed and all paperwork completed prior to shipping, make smaller lot sizes where one lot is equal to one shipment, or serialize each critical component and track devices by serial number from the beginning (probably not worth it for a low risk device).

If you had some products damaged during shipping, would you open an NCMR against the whole giant lot or just against a big list of serial numbers?

Regarding pre-approved rework, I agree with everything Zero_yield said.

 

[Zero_yield]

I'll also add that we have a product line that starts with 30,000+ of a molded component from a supplier, and we break it down to smaller batches for manufacturing purposes. The molded component material batch from the supplier is documented in the electronic DHR for each manufacturing batch for full traceability. One benefit (like indubioush has mentioned a few times) is that most problemst only affects one manufacturing batch. That one can be put on hold while the other tens of thousands of parts keep moving. Obviously, if there's a problem with the component from the supplier, every manufacturing batch it's in has to be controlled.

 

[Cybel]

There's three methods I can think of for documenting reprocessing we use.

One is like the retyping I mentioned above. A separate controlled form is printed where the reprocessing is captured and accompanies the DHR.

For one process, it can be performed up to two times. The DHR has a location for documenting Process A. It then has a section beside it "Reprocessing Process A" with an N/A checkbox available (since the majority of product is only processed once). Built into the DHR, there's the option to reprocess the batch, and that's reflected in the relevant procedures and documentation.

For the recleaning I was mentioning early, that's on a product line where the majority of the documentation is electronic within our ERP system. In this case, a supervisor or similar adds an additional "cleaning" router step to the electronic DHR, allowing technicians to document the recleaning. This is also documented in a comment on the physical traveler that moves with the batch, is retained, and is reviewed before final release.

We have several different processes that have some sort of "standard" reprocessing, but I think all of them would fall into one of those categories. Either there's a specific controlled document for that operation's reprocessing, it's baked into the DHR, or it's captured electronically by adding a router step.

Thanks. This is interesting, I'll think about how to improve our processes considering your methods.

Can you explain further?

Well, sometimes it happens that a device is sold from unauthorized stores or in unauthorized countries (I mean, from the point of view of agreements with distributors and language requirements, for example). Thanks to the SN we can understand who the first distributor was.
We could do this with LOT numbers as well, if we had 1 shipping=1 lot, but because actually the giant lot is an exception and we also may receive and ship orders for few units (50, 20 or less), we don’t want to make LOTs for each.

I don't see the benefit of having a giant lot with partial shipments. You could possibly be out of compliance with the below requirement:

(d) Final acceptance activities. Each manufacturer shall establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria. Finished devices shall be held in quarantine or otherwise adequately controlled until released. Finished devices shall not be released for distribution until:....

Each device is controlled 100%, so we complete the final acceptance activities for each S/N is released, and each group of SN is controlled against the production documents, DMR, order before releasing: finished devices are released for distribution after
(1) the activities required in the DMR are completed;
(2) the associated data and documentation is reviewed;
(3) the release is authorized by the signature of a designated individual(s); and
(4) the authorization is dated.
and after the acceptance activities are documented.

What is the difference between run, lot and batch?

If you had some products damaged during shipping, would you open an NCMR against the whole giant lot or just against a big list of serial numbers?

If damage is due to the shipping, I do this against that shipping only or against a specific outer box only: because we know what S/N are included in each outer box, we can keep under control the damaged boxes and returned units vs the delivered boxes and delivered units.
I suppose it may appears (and maybe it is) as an illusion of better keeping the process under control: however, basically we work well with serialization, except for the difficulties described in my first post.

 

[indubioush]

What is the difference between run, lot and batch?

Lot and batch are the same thing. It is interesting that the regulation uses the term "production run" but doesn't really define it. I take this to mean all of the units that were produced from a manufacturing process, especially one in which individual units are in different stages at a given time. Perhaps a production run can include different lots, but I'm not sure about this.

I think if you are following the regulation as you stated, and you make some changes to allow in-process rework, you should be fully compliant. As long as you can justify that the reworked units are homogeneous with the other non-reworked units, there should be no issue.