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

S

snappy

#21
Bear in mind that "repair" connotes an acceptable lack of conformity with all product requirements, while "rework" connotes "good as new."
 
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S

snappy

#22
I don't believe the difference between rework and repair has anything to do with pre-market or post-market. It has to do with the state of the resulting product, whether it meets all original product requirements, or enough of them to be acceptable for use.
 

Marcelo

Inactive Registered Visitor
#23
I don't believe the difference between rework and repair has anything to do with pre-market or post-market. It has to do with the state of the resulting product, whether it meets all original product requirements, or enough of them to be acceptable for use.
Yes, but a product usually needs to meet all product requirements premarket, and usually meets enough of them post-market. But there can be instances of rework in the post-market phase, and repair in the pre-market (although this last one is more difficult in a regulated environment).
 

somashekar

Staff member
Super Moderator
#24
I don't believe the difference between rework and repair has anything to do with pre-market or post-market. It has to do with the state of the resulting product, whether it meets all original product requirements, or enough of them to be acceptable for use.
We can twist and turn the words 'Rework' and Repair' from the english point of view, however we are talking about control of non conforming product = control of non conforming medical device servicing, which is a possible outcome from a servicing effort.
If we are talking about application of ISO13485 to medical device servicing scope, the above needs to be addressed and handled per the requirement of clause 8.3. Details and authorization about handling NC servicing situations needs to be flown down from the manufacturer to the servicing company.
The moment you are called in for servicing, you are dealing with a NC product, which is an input.
What ever and all that you perform is the servicing activity (your product per scope) and the output is expected to be a conforming product. If not, your servicing activity (your product per scope) may be non conforming, or the product is beyond your servicing ability. You need to address these situations in the QMS as the standard details.
a) by taking action to eliminate the detected nonconformity; = re-visit / re-service (rework, repair, whatever)
b) by authorizing its use, release or acceptance under concession; = (If trained and authorized to do from the original manufacturer)
c) by taking action to preclude its original intended use or application. = de-commission and return to manufacturer or other action that you are trained to do.
We need to go by the business sense and requirement and map activities to the standard's requirement.
 
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S

snappy

#25
We can twist and turn the words 'Rework' and Repair' from the english point of view,
The suggestion was that "rework" implied pre-market and "repair" implied post-market, as if "that's why" there was a distinction in definitions between the two. The distinction between rework and repair is valid (ISO 9000:2005), but it has nothing to do with pre-market or post-market--even in a regulated industry.

Anyway.

It seems the OP is worried (that her auditor thinks) she might have evidence of nonconforming service based upon the fact that her service department had to visit a company more than once to address a service issue. It seemed to spurn a question as to whether the product requiring service was "reworked" or repaired or what. (The auditor was applying the "rework" requirements to this situation.) But it was the repair/rework issue being entertained at the time you joined.

If the auditor's evidence consists of nothing more than the fact that more than one service visit was required for a service call, it seems difficult to conclude from that alone whether the provided service is nonconforming. (Some service operations could reasonably require multiple visits to complete.) But if all the auditor has is evidence of a repeat visit, I wouldn't want the auditor questioning whether my service provision is nonconforming, either.

The frequency of service calls alone is not a valid indication of service nonconformity.

In cases where service contracts are in place, the provided rework or repair is not expected or intended to prevent recurrence of the need for future service, contrary to where the auditor appears to be headed here.

Reviewing calls for proper performance, and repeat calls for potential poor performance, is a fine idea.
 
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Marcelo

Inactive Registered Visitor
#26
The suggestion was that "rework" implied pre-market and "repair" implied post-market, as if "that's why" there was a distinction in definitions between the two. The distinction between rework and repair is valid (ISO 9000:2005), but it has nothing to do with pre-market or post-market--even in a regulated industry.

Who is twisting what here?
There´s no twisting here, the suggestion was that rework may be seen as related to premarket and repair for post market of a device. ISO 9001 does not say so, but knowing regulations from medical device, some of them do.
This distinction was necessary because the OP, which provides services in the post-market phase, is trying to apply ISO 13485, and is trying to understand why the requirement does not seem to fit.

The fact that it´s in a regulated environment do impact the final solution - as regulatory requirements have precedence over ISO 13485 (because the standard itself says so), if applied in the US you do have to use the definition of rework as per the FD, meaning, rework is related to a situation before putting the product into the market. The fact that ISO 9001 does not say this does not matter in such a situation.
 
S

snappy

#27
Marcelo, you said: "That´s why there´s a subtlety in the definitions. Rework put the product in conformance with the requirements - this is a new product (it´s a product that´s just been created). Repair make the product acceptable for use - this is not a new product, not a product that has just been created."

This is what I am taking issue with. Even in a regulated environment, a supplier with nonconforming product can request permission from the customer to repair and supply the repaired product--even if the product is still in production. So long as the appropriate impact investigations are performed, etc., and the appropriate approvals are in order, this is acceptable. On the other hand, a medical grade surface plate might be reworked every year.

To say, "That's why there's a subtlety in the definitions"--rework is for new product, and repair for not new products--is simply wrong.
 
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S

snappy

#28
ISO 9001 does not say so, but knowing regulations from medical device, some of them do.
So far, I have worked with designers and manufacturers of several devices in regulated industries (medical . . . and aerospace--don't forget the FAA). Medical device QMSs include those for products like orthodontics, needle-free injection systems, implantable hearing devices, x-ray devices, insert-able (shall we say) digital imaging systems.

I haven't seen this one, not to say it's not there. Can you give me an example?
 

Marcelo

Inactive Registered Visitor
#29
Hum, I don´t thinks this discussion is really helping the OP anymore, but anyway, answering your comments and questions:

To say, "That's why there's a subtlety in the definitions"--rework is for new product, and repair for not new products--is simply wrong.
You are right, the original definition from ISO 9001 does not say anything like that.


I haven't seen this one, not to say it's not there. Can you give me an example?
As I have mentioned in a post above, the definition of rework from 21 CFR 820 is:

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

certified1

Starting to get Involved
#30
Assuming that you inspect the devices before selling, rework of a medical is the return of that device to the vendor or supplier after it has failed quality control inspection in order to correct the nonconforming product.
 
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