Question about ISO 13485:2003 - Production Provisions - Contract Manufacturer

#1
Hi everyone,

A small medical device company (company A) is currently transitioning the production process in house from a contract manufacturer (CMO) who up until spring 2017 was assembling the finished device for company A. Here is the issue. Company A's products are known as "built-to-order" (they manufacture the product only when there is a new order from a customer). Since transitioning from the CMO, there has not been an order. We do not have a set of DHRs in time for an ISO surveillance audit. Would it matter if we have not assembled the DHRs yet however the manufacturing facility (Company A) just has the SOPs in place? The auditor will not have the DHR records to look at (as in product assembled in house). How would this affect this audit?

Thank you.
 
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Ronen E

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#2
I don’t see a problem with not having DHRs for production runs that didn’t take place because there were no orders and the org manufactures to-order (and all this is backed by the SOPs).

I would, though, expect company A to have copies of past runs’ DHRs, or at least easy access to the originals (so that they’re available for A’s external auditor on request).
 

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#3
Agree with Ronen that I would not worry about not having DHRs when there has been no production. What I think is important to have for the audit is a thorough and well-documented change. And I'd also expect that there have been manufacturing runs as part of the change to get the processes in-house (there must have been some kind of design-transfer, right?). Maybe the devices were not marketed because destroyed during the activities to verify the change and maybe employee training was performed using dummies etc. but I would expect you to have some kind of DHRs from those activities probably with documents having a draft-status...
 

Ronen E

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#4
Agree with Ronen that I would not worry about not having DHRs when there has been no production. What I think is important to have for the audit is a thorough and well-documented change. And I'd also expect that there have been manufacturing runs as part of the change to get the processes in-house (there must have been some kind of design-transfer, right?). Maybe the devices were not marketed because destroyed during the activities to verify the change and maybe employee training was performed using dummies etc. but I would expect you to have some kind of DHRs from those activities probably with documents having a draft-status...
I would name such transfer documentation Process Validation (and prior to that, process development and qualification). It must exist, but it’s not DHRs, which are normally collections of sellable devices production records (or at least devices made with the main goal being sale / clinical use).

I fully agree regarding change control.
 
#5
Hi all. Thanks so much for the replies. There is no design transfer because we design the device. But you suggest doing a dummy run to show process validation instead of a full DHR. Please clarify my understanding. Thanks.
 

TWA - not the airline

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#6
I would name such transfer documentation Process Validation (and prior to that, process development and qualification). It must exist, but it’s not DHRs, which are normally collections of sellable devices production records (or at least devices made with the main goal being sale / clinical use).
DHR is a term defined in the CFR not the ISO. Whether you'd consider the production records from the transfer to be part of the DHR or not probably does not matter for an ISO surveillance audit. What matters is that there are records that can be audited that are very similar to the production records of the regular product, i.e. same routing, BOM, forms for inspections records and so on.
 

TWA - not the airline

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#7
Hi all. Thanks so much for the replies. There is no design transfer because we design the device. But you suggest doing a dummy run to show process validation instead of a full DHR. Please clarify my understanding. Thanks.

You designed the device and obviously the contract manufacturer did make finished product, so there must have been some kind of design transfer...:confused:
 

Ronen E

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#8
DHR is a term defined in the CFR not the ISO. Whether you'd consider the production records from the transfer to be part of the DHR or not probably does not matter for an ISO surveillance audit. What matters is that there are records that can be audited that are very similar to the production records of the regular product, i.e. same routing, BOM, forms for inspections records and so on.
I agree with most of what you say. I was just trying to highlight that the sort of activity normally expected in such a situation wouldn’t necessarily produce the routine-type looking “DHR” (regardless of audit scheme). A subset yes, most likely. We don’t know enough about the OP’s org SOPs for both process validation and routine production, and what they’ve actually done in this instance, to say for sure. The outcome also depends a lot on the latitude they’ll get from the auditors (org and individuals).

You designed the device and obviously the contract manufacturer did make finished product, so there must have been some kind of design transfer...:confused:
That sort of transfer must have occurred in the direction [design owner] —> [contract manufacturer]. Therefore any production records related with this transfer would obviously be expected at the CM side. Whether or not copies also exist in full at the handing over party is not that obvious.
 

Ronen E

Problem Solver
Staff member
Moderator
#9
Hi all. Thanks so much for the replies. There is no design transfer because we design the device. But you suggest doing a dummy run to show process validation instead of a full DHR. Please clarify my understanding. Thanks.
Hi,

Regardless of any design transfer (any direction), your org has changed the manufacturing site (to say the least) and therefore you’d have had to run a process validation at the new site, or at the very least qualified the production at the new site (new equipment, new operators etc.). I wouldn’t call it “a dummy run”; there is very elaborate guidance available on what a process validation needs to include.

The process validation is not required “instead of a DHR”; it is required for its own sake, because you are starting production at a new site (new for this process). It was suggested that as a by-product such a process validation may produce records that might possibly satisfy the auditors in the absence of “true” DHRs.

Cheers,
Ronen.
 

TWA - not the airline

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#10
That sort of transfer must have occurred in the direction [design owner] —> [contract manufacturer]. Therefore any production records related with this transfer would obviously be expected at the CM side. Whether or not copies also exist in full at the handing over party is not that obvious.
Agree, my point was not about the production records here, but that I would expect the design owner to have some documentation that shows that a design transfer occurred and that this activity was planned and verified or validated as appropriate. To understand this is important for the OP as it will be a very bad start for the audit when the auditor hears something like "Oh, there was no design transfer because...". Even if later on all necessary documentation will be found the auditor will get the impression that there is a lack of knowledge regarding the requirements of ISO 13485.
 
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