Define "Rework" Under Medical Device Standards

B

Beth Workman

#1
We extrude component tubing for medical devices. With extrusion a true re-work of our standard process is never done because we cannot reprocess the raw material for medical devices. However, in one occasion this past year we received a returned product that was cut to the incorrect length and had to trim the product to its required specification.
I would, and did, consider this a re-work, as we were altering the parts from their originally produced state, however, there are some that disagree with my assessment on this.
Looking for some input on this one.
Do you agree or disagree with my assignment of this term? Why or why not?

Thanks!
 
Elsmar Forum Sponsor
#2
Rework: A process that adds, removes, or replaces parts to create an item with a changed bill of materials. The configuration of the inbound device or sub-assembly changes to a different configuration when it leaves the process. Configuration in, does not equal configuration out at some level.

Repair: A process that replaces one or more parts with conforming parts of the same part number(s) (including dash number) to bring the product into compliance.

This is how we operate. Successful Manufacturer, Re-worker, repairer of Class III medical devices and being audited by FDA.

Hope it helps.
QE.
 
P

Pudge 72

#4
Your assessment is spot on.
However, also being in the Medical Device / Component manufacturing industry there are more than just a few who disagree with me and refuse to even acknowledge the term re-work and its associated meaning.
Rework is not an approved process, period end if story. If you didn't have a non-conformance you wouldn't have rework.:notme: But, you cannot have a non-conformance because there is all kinds of bad things associated with that. :lmao:
 

Al Rosen

Staff member
Super Moderator
#5
Rework: A process that adds, removes, or replaces parts to create an item with a changed bill of materials. The configuration of the inbound device or sub-assembly changes to a different configuration when it leaves the process. Configuration in, does not equal configuration out at some level.

Repair: A process that replaces one or more parts with conforming parts of the same part number(s) (including dash number) to bring the product into compliance.

This is how we operate. Successful Manufacturer, Re-worker, repairer of Class III medical devices and being audited by FDA.

Hope it helps.
QE.
You have it backwards. Rework brings it into conformance to drawing & spec requirements while a repair does not meet all drawing requirements but makes it functional. Look at From MIL-STD-1520C, Corrective Action and Disposition System for Nonconforming Material
 

Marcelo

Inactive Registered Visitor
#6
On medical device standards (Basically ISo 13485), rework is applied only to the finished non-conforming product and means bringing the prodict back into full conformity so it can be sent to the customer as new.
 
M

MIREGMGR

#7
We recently had a periodic re-assessment during which rework became a discussion topic and eventually an OFI.

Among our many other processes, we apply flexomeric coatings to fabricated-complex-shaped flexible polymeric foam materials so as to create multiple-use, practically cleanable patient positioners for medical imaging applications. The general first step in application of the coating is a spray process. This step often, but not always, results in pinholes, which are identified by visual inspection of each part after the first drying step. A subsequent step involves various microtechniques for pinhole patching using small quantities of the same coating. Visual inspection and patching continues until each part is determined to meet specs, i.e. no detectable pinholes.

We don't have the option of engineering out the creation of pinholes. That's been studied in the past. They're inherent to the materials and micromorphologies in question. We don't know of any other materials that would result in end products that would be as safe and effective.

Our work process is formally procedurized, but in a soft way. There isn't a quantification of how many pinholes is too many, or what percentage of total area can be patched, or any other characteristic other than that a part with unpatched pinholes does not meet specs but is eligible for further work, and a part with no remaining pinholes (and other quality characteristics, able to be consistently discriminated) does meet specs.

We've been doing this for approximately 32 years with hundreds of thousands of multiple-use devices sold, and essentially complete user satisfaction. The products are simple, relatively inexpensive and clinically safe and effective.

The involved auditor has asked us to define when the existing production process ends, and rework begins. His argument is that at some point, this patching or touchup process must be rework. He wants the existing procedure to be quantified to the extent possible.

Because of the subjective nature of the process and the vague meaning of rework in the context of such subjective processes, we haven't decided how to proceed. We take OFIs seriously, but we are leaning toward this one being too difficult to do in the way he would like.
 
R

Roland Cooke

#9
Off the cuff, I would make the case that MIREGMGR's example isn't rework...it's a (vaguely) circular manufacturing process that doesn't finish until the part meets spec.

To my mind rework would apply if a part was deemed to be free of pinholes...and only subsequently found to not be, i.e. it's non-conforming product.
 
L

Laura Halper

#10
I agree with Roland. I do not think there is anything wrong about a process in which some of the steps may be repeated as necessary.

I'm assuming that MIREGMGR's plant does not write up a non-conformance each time they have to patch some pinholes. This is because they have determined (with 32 years of experience!) that some frequency of pinholes is inherent in their process. So I would consider that the entire process includes initial spray, inspection, and subsequent patching as needed.

Since the auditor wants a definition of when the process ends and rework begins, I would suggest defining the process as above (spray, inspect, patch as needed). Rework could be defined as re-processing that is done after the part has been released for the next operation, or re-processing done on product returned from the customer.

I think you could draw an analogy with a craftsman's work. For example, a carpenter may sand a piece, inspect it for smoothness and shape, and then resand and reinspect several times. The inspection and resanding is part of the process. But if a customer returned a piece because they got splinters, then the carpenter would be doing re-work when he resanded the returned part.
 
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