ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process?

ThatSinc

Involved In Discussions
#1
Hi All,

Working with a small manufacturer that uses in-house machined components.
All sub-assemblies and final products are hand assembled, no automated assembly, and parts are inspected at the time of use.
all finished goods are tested.

Machined components have technical drawings that provide all dimensions and the finish specifications - from deburr and clean performed in-house to various anodising/plating operations performed by third parties.

If a part is identified during the assembly processes as requiring deburring, or as unclean, or a particular tapped hole is too short (potentially with a burr on the end of the tap for example) would it be expected that each of these instances to be handled as per the non-conforming materials process prior to any deburring/cleaning?

Or would it be compliant to have an instruction within the assembly procedures/work instructions that parts should be checked for burrs and cleanliness prior to use and deburred/cleaned as per the relevant standard approved instructions?

This operation then becomes a part of the standard process, rather than any special rework process, however I'm concerned it still does not alter the fact that the parts that were on the shelf as completed and ready for use were not conforming to their requirements of being cleaned/deburred etc.
I appreciate the inefficiencies of this, and it would not lead to improvement through investigation of why parts were received uncleaned/deburred from the machine shop.


Thanks in advance,

TS.
 
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LukasLosigkeit

Starting to get Involved
#2
An important aspect of rework under ISO 13485 is to determine the possible adverse effect of the rework.
All reworked products need to be of the same quality as non-reworked products.

The standard requires that rework is done in accordance with documented procedures. But it does not explicitly state that rework may not be included in another process.
In my experience, rework is often included in processes such as NC handling.

A problem that may arise from including rework in the production process is, that the potential adverse effect is not assessed.
 

yodon

Staff member
Super Moderator
#3
I wouldn't handle these as NC product since they haven't passed any inspection yet. As @LukasLosigkeit points out, the rework should be well-managed and assessed. It would likely be a good idea to track and trend such instances - maybe it's an indication of some equipment maintenance need, maybe training, etc.

One thing you said was concerning:

...however I'm concerned it still does not alter the fact that the parts that were on the shelf as completed and ready for use were not conforming to their requirements of being cleaned/deburred etc.
On the surface, that sounds like you may not be fully compliant with 7.5.8 Identification.
 

ThatSinc

Involved In Discussions
#4
In my experience, rework is often included in processes such as NC handling.
That's my experience too, a rework wouldn't be initiated until an NC had been identified, logged, and evaluated.

A problem that may arise from including rework in the production process is, that the potential adverse effect is not assessed.
Understood, this would need to be carefully managed depending on the nature of the issue.
In the case of deburring, anodized or plated components wouldn't be reworked as the activity of deburring after these processes would remove the finish.

I wouldn't handle these as NC product since they haven't passed any inspection yet.
Would the inspection at time of use in assembly not be considered the time at which parts would be identified as conforming or not conforming to their drawing specification? At which time any that have burrs or short taps would be deburred or tapped by the assembly staff.

Personally I can't see how this would not be considered to be non-conforming and require going through the formal NC process, though I would love for that to be the case as it will allow the process to continue as is for now with minor changes.

It would likely be a good idea to track and trend such instances - maybe it's an indication of some equipment maintenance need, maybe training, etc.
Agreed entirely.


On the surface, that sounds like you may not be fully compliant with 7.5.8 Identification.
How so?
Parts are machined, de-greased, rumbled, and then go through a cleaning process before the works order and batch is closed and the parts are placed into the appropriate storage bins for use in assembly.
It's not a case that *no* parts were cleaned/degreased, parts are appropriately segregated following machining (in an area that is clearly marked as requiring further processing) and the route cards included with the batches identify which processes have been completed and which are still outstanding.
During assembly each part is inspected for its appearance and fit, and occasionally there will be parts that still have a burr or blemish.


I wouldn't like to include the inspection of the part at time of use in assembly as a part of the manufacturing process for the part itself, as that would require the assembly staff to complete batch paperwork for the machining/cleaning of parts.
 

LukasLosigkeit

Starting to get Involved
#5
Personally I can't see how this would not be considered to be non-conforming and require going through the formal NC process, though I would love for that to be the case as it will allow the process to continue as is for now with minor changes.
It is possible to use the NC handling procedure for rework. You can include the rework requirements of ISO 13485 into the existing procedure. And, as agreed before, consider the adverse effect of the rework. This needs to be documented somewhere.
 

ThatSinc

Involved In Discussions
#6
It is possible to use the NC handling procedure for rework. You can include the rework requirements of ISO 13485 into the existing procedure. And, as agreed before, consider the adverse effect of the rework. This needs to be documented somewhere.
That's something I've been looking at for "standard reworks" such as removing burrs from a drilled chassis (just writing "standard reworks" is making my skin crawl).
8.3.4 - These procedures shall undergo the same review and approval as the original procedure.
If the (Tier 2) rework procedure, including standard/acceptable reworks and consideration of adverse effects, is approved by the same functions that approved the (Tier 3) works instructions for the original machining/cleaning process, and then the inspection is the same as the original parts - this requirement should be satisfied.

but still has the requirement to go through the NC process.

The assembly teams are frustrated that they have to deburr the chassis that come from the machine shop, but more so they don't want to be filling in NCR forms and logs to give that quality data to show that there is a problem to solve it :frust:
 

yodon

Staff member
Super Moderator
#7
Maybe I'm misunderstanding your process. In my mind, at workstation A, the parts are machined, etc. and the operator completes the task. Before they move past workstation A, an inspector looks for burrs, etc. At that time, the parts have not been accepted as complying and so they can be reworked to bring them into an acceptable state. If, however, those parts were inspected, passed, moved to workstation B, and THEN the issue was found, I think an NC is in order because the parts had been accepted.

As @LukasLosigkeit points out, you can use your NC process for rework but I think that introduces a significant amount of overhead and cost.
 

ThatSinc

Involved In Discussions
#8
Maybe I'm misunderstanding your process. In my mind, at workstation A, the parts are machined, etc. and the operator completes the task. Before they move past workstation A, an inspector looks for burrs, etc. At that time, the parts have not been accepted as complying and so they can be reworked to bring them into an acceptable state. If, however, those parts were inspected, passed, moved to workstation B, and THEN the issue was found, I think an NC is in order because the parts had been accepted.
No inspection at all until the assembly stage aside from some dimensional checks during the machining process.

Workstation A - Parts Machined - Inspection for dimensions through process
Stored on "machined parts for finishing" shelves with paperwork
Workstation B - Parts Degreased/Deburred/Cleaned
Batch closed as completed parts for use in assembly - placed in storage bin.

Workstation C - Parts retrieved from storage bins, inspected, and assembled into sub-assemblies and finished devices.


As @LukasLosigkeit points out, you can use your NC process for rework but I think that introduces a significant amount of overhead and cost.
That's what I'm trying to reduce, but can't see a way around it with the current process.


At that time, the parts have not been accepted as complying and so they can be reworked to bring them into an acceptable state.
How would the rework be captured and documented, if not through the inspection process identifying that they are non-conforming, and going through the NC Process?
 

yodon

Staff member
Super Moderator
#9
How would the rework be captured and documented, if not through the inspection process identifying that they are non-conforming, and going through the NC Process?
What I've seen is just a simple rework addendum attached to the traveler.

But step back a second. What if you put in something simple as a peer inspection before moving them to the "machined parts for finishing" shelf? Maybe think of how you could eliminate or reduce the occurrence?

If you did go the NC route, you're probably never going to conclude that an investigation is warranted and you're always going to just take actions to eliminate the issue.

I've seen a number of board manufacture companies that run the board through the equipment then have some automated inspection system that flags issues. Those boards are just reworked, no NC.
 

ThatSinc

Involved In Discussions
#10
I'd love to put in an inspection process during the machining stage - It's not going to happen, even if it was just sampling.

The NC Process requires that repeated occurrence of minor issues over multiple batches are investigated under CAPA.

I've seen a number of board manufacture companies that run the board through the equipment then have some automated inspection system that flags issues. Those boards are just reworked, no NC.
I still struggle with how the in-process inspection doesn't count under 8.2.6 monitoring of product, and therefore requires evidence of conformity to specification and therefore the NC process when monitored product doesn't meet specification?
 
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