Help with ISO 13485 Clause 8.3 "Rework" as applicable to Medical Device Servicing

XeniAnnoula · Jul 13, 2012

Hello again --

Second post, this time on section 8.3 and that tricky "rework".

Our company sells and services (only) medical devices and we are now preparing to be certified against 13485. I am the QM for our company, and have worked with our ISO advisor for almost a decade, up to this point in regard only to our 9001 certification.

We are running into a couple of disagreements as we prepare for 13485. This is one of them: she is interpreting "If product needs to be reworked ..." in 8.3 to include any need for us to make a service visit (for the same reported issue) more than once. We consider this simply part of a normal service routine which sometimes requires more than one visit to resolve a problem. I'm afraid I feel she's misinterpreting the intention of this part of the standard, specifically the meaning of this word. While I have the utmost respect for her knowledge and brain-power under most circumstances, we may have a language issue here as her native language is not English while mine is (her command is superb, however -- don't misunderstand please).

I've read everything on this site regarding the meaning of "rework" and while I can see that there are some shades of difference between industries and applications, it seems quite clear that while both 'rework' and 'repair' can apply to the manufacturing process, I see no evidence of 'rework' per se applying to post-manufacture ('repair' however clearly can apply). And I find no support whatsoever for 'rework' being equivalent to 're-repair'.

If anyone's familiar with the paragraph to which I'm referring, you'll understand why I/we don't wish to be forced into this documentation/work instruction/authorization/approval loop unnecessarily, especially since we've taken great pains thus far with our QMS to weed out any administrative busy-work. :frust:

I'd hugely appreciate any opinions out there, pro or con. I'll stand up for my position on this if needed, but I don't want to cross our advisor without being 110% certain of my position.

Thanks!

somashekar · Jul 13, 2012

XeniAnnoula said:
Hello again --

Second post, this time on section 8.3 and that tricky "rework".

Our company sells and services (only) medical devices and we are now preparing to be certified against 13485. I am the QM for our company, and have worked with our ISO advisor for almost a decade, up to this point in regard only to our 9001 certification.

We are running into a couple of disagreements as we prepare for 13485. This is one of them: she is interpreting "If product needs to be reworked ..." in 8.3 to include any need for us to make a service visit (for the same reported issue) more than once. We consider this simply part of a normal service routine which sometimes requires more than one visit to resolve a problem. I'm afraid I feel she's misinterpreting the intention of this part of the standard, specifically the meaning of this word. While I have the utmost respect for her knowledge and brain-power under most circumstances, we may have a language issue here as her native language is not English while mine is (her command is superb, however -- don't misunderstand please).

I've read everything on this site regarding the meaning of "rework" and while I can see that there are some shades of difference between industries and applications, it seems quite clear that while both 'rework' and 'repair' can apply to the manufacturing process, I see no evidence of 'rework' per se applying to post-manufacture ('repair' however clearly can apply). And I find no support whatsoever for 'rework' being equivalent to 're-repair'.

If anyone's familiar with the paragraph to which I'm referring, you'll understand why I/we don't wish to be forced into this documentation/work instruction/authorization/approval loop unnecessarily, especially since we've taken great pains thus far with our QMS to weed out any administrative busy-work.

I'd hugely appreciate any opinions out there, pro or con. I'll stand up for my position on this if needed, but I don't want to cross our advisor without being 110% certain of my position.

Thanks!

Our company sells and services (only) medical devices and we are now preparing to be certified against 13485.

Are you the authorized service company for the medical devices manufacturer within warranty and later as well ?
If so, your service and testing instructions as provided by the manufacturer will come in handy for service or re-service or re-re-service. The point made here in this clause is a strong one about any re-work not compromising on the safety and effectiveness of the medical device as regard to its intended use. You must be familier with the risk management information of the medical device to be sure that the service is being done in the defined way, any number of times.
If you are not the authorized service company of the medical device manufacturer ...?
I will have many questions and we can see how it moves further. There are other experts on medical devices who will pitch in.

XeniAnnoula · Jul 13, 2012

Somashekar, again, thank you so much for so quickly trying to help!

Yes, we are indeed the (sole) authorized service company for this equipment in this country. Our technical support guys are manufacturer-trained and very experienced and fully equipped with manuals and support from the manufacturer. They are fully aware of any involved safety issues -- this is not a concern. We are responsible for some of the most critical equipment in the hospital and take that responsibility very seriously.

My reason for trying to clarify this issue is to keep our QMS "clean" of any unnecessary paperwork-for-the-sake-of-paperwork. We already document our interactions with our customers' equipment quite well, both on a by-case and by-customer basis, and on what we call an 'equipment record card' so that we can see all interactions with one specific piece of equipment at a single glance.

But with a good share of our overall business being service, and the very nature of that being that not all equipment problems can be solved in a single visit, I'm trying to avoid over-documenting, so I 'kick' when I think something doesn't apply and/or is covered elsewhere. Does that make sense? Going through an authorization and approval process as well as an analysis of any potential adverse effects ... and documenting all of this! ... each and every time we need to work on a specific piece of equipment more than once strikes me as insanity. But more to the point: it does not appear to me to be the intention of this part of 8.3 which refers at the top of the section to product being controlled prior to 'use or delivery'. SURELY this reference to 'product' in this particular case (section) is to tangible goods rather than 'service', no?

Please feel free to ask any questions which would clarify this for you!

somashekar · Jul 13, 2012

XeniAnnoula said:
Somashekar, again, thank you so much for so quickly trying to help!

Yes, we are indeed the (sole) authorized service company for this equipment in this country. Our technical support guys are manufacturer-trained and very experienced and fully equipped with manuals and support from the manufacturer. They are fully aware of any involved safety issues -- this is not a concern. We are responsible for some of the most critical equipment in the hospital and take that responsibility very seriously.

My reason for trying to clarify this issue is to keep our QMS "clean" of any unnecessary paperwork-for-the-sake-of-paperwork. We already document our interactions with our customers' equipment quite well, both on a by-case and by-customer basis, and on what we call an 'equipment record card' so that we can see all interactions with one specific piece of equipment at a single glance.

But with a good share of our overall business being service, and the very nature of that being that not all equipment problems can be solved in a single visit, I'm trying to avoid over-documenting, so I 'kick' when I think something doesn't apply and/or is covered elsewhere. Does that make sense? Going through an authorization and approval process as well as an analysis of any potential adverse effects ... and documenting all of this! ... each and every time we need to work on a specific piece of equipment more than once strikes me as insanity. But more to the point: it does not appear to me to be the intention of this part of 8.3 which refers at the top of the section to product being controlled prior to 'use or delivery'. SURELY this reference to 'product' in this particular case (section) is to tangible goods rather than 'service', no?

Please feel free to ask any questions which would clarify this for you!

Do not worry about the device or tangible product. Your product for the QMS scope is "Servicing of Medical devices" and so keep to this simply.
The manufacturer authorizes you (actually the servicing personnel) to approve after servicing and testing under normal situations. Are they also skilled and authorized to release after servicing with any concessions ? If so what are they and are they documented ?
Either he is authorised and trained on concession approval after servicing, or he is simply asked to return the device to the factory for further actions. This ends the servicing role.
All the paperwork that you normally do after servicing and the approved device servicing manual (a current controlled document from the manufacturer) will meet your requirement.

MIREGMGR · Jul 13, 2012

XeniAnnoula said:
it does not appear to me to be the intention of this part of 8.3 which refers at the top of the section to product being controlled prior to 'use or delivery'. SURELY this reference to 'product' in this particular case (section) is to tangible goods rather than 'service', no?

In this instance, I agree with you. My view is that the intent of "rework" pertains to manufacturing (i.e. the repair or make-good of the percentage of output that did not meet specifications after original manufacture), and not to either bespoke fabrication or servicing, for which it is normal that the original work completion may involve multiple work sessions and some "rework".

db · Jul 13, 2012

I could see some "rework" in the service industry. For example, you replace a circuit board, but do not properly connect a ribbon wire. Two days later, the unit fails because the wire lost contact. Upon your return, you discover the improperly connected wire. Since the unit failure was due to your actions, I would consider this "rework". It might be a stretch, but is the best I can think of at the moment.

Marcelo · Jul 13, 2012

Rework is intended to br pre-market. Repair can be post-market, as clear on the note to the definition of repair - and only repair - in ISO 9001 - NOTE 1 Repair includes remedial action taken on a previously conforming product to restore it for use, for example as part of maintenance.

Marcelo · Jul 13, 2012

SURELY this reference to 'product' in this particular case (section) is to tangible goods rather than 'service', no?

Nope. Product, as per ISO 9001, is defined as the result of a process. So it can be a physical good or the intangible result of a process.

If you didn't do it already, I would suggest a good read on ISO 9000 definitions, much of the problems related to rework, repair, etc, in standards came from not using the right definition.

MIREGMGR · Jul 13, 2012

Marcelo Antunes said:
Product, as per ISO 9001, is defined as the result of a process. So it can be a physical good or the intangible result of a process.

It's difficult to define what the process is and where rework might begin, though, if/when service includes (1) investigative diagnosis and (2) iterative change-and-test repair, such as board swapping, with no clear demarcation of the boundary between (1) and (2), and sometimes no quickly clear certainty that (2) is done until further equipment use determines that a "flaky" or occasional problem has ceased to recur.

I appreciate the nature of ISO 9001's requirements, but I think the OP has a point in regard to how to practically apply the ISO 9001 "theory", if you will, to the practical nature of their work.

Marcelo · Jul 13, 2012

It's difficult to define what the process is and where rework might begin, though, if/when service includes (1) investigative diagnosis and (2) iterative change-and-test repair, such as board swapping, with no clear demarcation of the boundary between (1) and (2), and sometimes no quickly clear certainty that (2) is done until further equipment use determines that a "flaky" or occasional problem has ceased to recur.

I appreciate the nature of ISO 9001's requirements, but I think the OP has a point in regard to how to practically apply the ISO 9001 "theory", if you will, to the practical nature of their work.

You are correct, however, I was dealing with this in my other answer, maybe I was not very clear.

In the case of the example, I don't think rework as defined in the standards applies the way the advisor is interpreting. Rework, as I understand, is focused in being applied applied pre-market (although I can think of some situations in post-market which needs rework), and service (which is related to "correct" something in the field)is post-market. So service visits are repair, as defined in the standards, not rework.

The particular requirement for rework in 8.3 of ISo 13485 is focused on the case of where your product (being a hardware, software, or service) has a non-conformity prior to being delivered, and thus need to be put into conformance before being released. This should be an uncommon situation, that's why there's very detailed requirements that you need to document and authorize and everything.

This is more clear in 21 CFR 820 where it defines rework as

(x)Rework means action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution.

Help with ISO 13485 Clause 8.3 "Rework" as applicable to Medical Device Servicing

XeniAnnoula

somashekar

XeniAnnoula

somashekar

MIREGMGR

db

Marcelo

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Marcelo

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MIREGMGR

Marcelo

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