Medical Device Circuit Board Component Changes - Is this rework or not?

My company is building a circuit board assembly for a customer. This is for a medical device and is for a new product. After the assemblies were completely built, the customer has come back to have 2 parts 'changed' on them. They claim it is not rework. It is just two component changes to go from the old revision to the current revision.

I'm sorry but this reads as rework to me and therefore should be controlled by rework instructions and should have the adverse effects reviewed before performing the rework.

Am I right or wrong on this?

Adding: Oh, and ISO 13485 is definitely a requirement with this job.

RCW said:

My company is building a circuit board assembly for a customer. This is for a medical device and is for a new product. After the assemblies were completely built, the customer has come back to have 2 parts 'changed' on them. They claim it is not rework. It is just two component changes to go from the old revision to the current revision.

I'm sorry but this reads as rework to me and therefore should be controlled by rework instructions and should have the adverse effects reviewed before performing the rework.

Am I right or wrong on this?

Adding: Oh, and ISO 13485 is definitely a requirement with this job.

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When you say "changes to go from the old revision to the current revision", do you mean the delivered PCBA wasn't current? Can you clarify?

By definition, REWORK is to change an item in order to improve it or make it more suitable for a particular purpose, e.g. to rework a defective product into one that exhibits the quality required for acceptance. If the delivered PCBA met the BOM requirements, any alteration to make it suit another purpose is certainly rework.

Did they offer any explanation as to why they don't consider it rework?

Mikishots said:

When you say "changes to go from the old revision to the current revision", do you mean the delivered PCBA wasn't current? Can you clarify?

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"changes to go from the old revision to the current revision" is from the actual email I saw explaining why this isn't rework. It appears it was a design change even though these are production boards.

Mikishots said:

Did they offer any explanation as to why they don't consider it rework?

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After some further investigation, I found the company that did not consider it rework is a subcontractor to my customer. I also found out that they like to run their business loose and under the table, which explains why it wasn't rework in their eyes.

Mikishots said:

By definition, REWORK is to change an item in order to improve it or make it more suitable for a particular purpose, e.g. to rework a defective product into one that exhibits the quality required for acceptance.

Click to expand...

Just curious, did this definition come directly from a source or was it paraphrased? I've seen a few definitions of rework before but this one seems slightly different from what I have encountered.

I'm not attacking the definition, just trying to find the source.

Hi,

The important thing is that the work is controlled and risks are mitigated. One could term it in more than one way. It could be rework but to me it seems more of a design change (which would warrant risk analysis just the same). The reason I don't lean towards the rework terminology is that the reason for parts replacement wasn't a defect or failing some predefined test etc. (at least not according to available info). It sounds more like an intended change in desired performance.

You could define in your records describing the change and the work (components replacement) that the material input for making the new version is actually the old version units, provided by the customer (if I got it right and they were actually already delivered, then returned).

Just my opinion, no "legal" quotes here

Cheers,
Ronen.

I'm sorry but this reads as rework to me and therefore should be controlled by rework instructions and should have the adverse effects reviewed before performing the rework.

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Hi RCW... Yes
You are spot on.
The circuit board has come made under controlled conditions, and when you engage in doing the suggested changes, due care has to be taken to ensure that no other damage is induced on the balance part of the circuit board, which may have impact on the safety and effectiveness of the final device. To ensure this certain controls are necessary (aka rework instructions) and certain tests further to rework to ensure the rework is in order and the circuit board performs per the new changes / current revision.

Okay, I was discussing this problem with someone here and now I am sitting on the fence between it's procedure-controlled rework and it's not.

These boards were built by my supplier. My supplier is not registered to ISO 13485. The supplier was in error and the supplier reworked the board. So it's a question of should this be viewed from the assembly (the board goes in a medical device therefore rework to approved procedures) OR view it from the supplier (he is just building a board and will rework to his own internal methods).

If I was building the board at my facility, it's cut & dried - rework procedure required. Having a supplier build, I'm confused as to what is applicable.

RCW said:

Okay, I was discussing this problem with someone here and now I am sitting on the fence between it's procedure-controlled rework and it's not.

These boards were built by my supplier. My supplier is not registered to ISO 13485. The supplier was in error and the supplier reworked the board. So it's a question of should this be viewed from the assembly (the board goes in a medical device therefore rework to approved procedures) OR view it from the supplier (he is just building a board and will rework to his own internal methods).

If I was building the board at my facility, it's cut & dried - rework procedure required. Having a supplier build, I'm confused as to what is applicable.

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Control over outsourced process is applicable and in this control the rework method, risk assessment and necessary verification after rework applies.... AS IF the board is being built at your facility.

RCW said:

Okay, I was discussing this problem with someone here and now I am sitting on the fence between it's procedure-controlled rework and it's not.

These boards were built by my supplier. My supplier is not registered to ISO 13485. The supplier was in error and the supplier reworked the board. So it's a question of should this be viewed from the assembly (the board goes in a medical device therefore rework to approved procedures) OR view it from the supplier (he is just building a board and will rework to his own internal methods).

If I was building the board at my facility, it's cut & dried - rework procedure required. Having a supplier build, I'm confused as to what is applicable.

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Hi,

Now that you've clarified that the component replacement was due to an initial error, I agree that in general this would fall under "rework". The previous description was not as clear.

It is totally legitimate to qualify and utilize suppliers not certified to 13485; as long as your evaluation and qualification processes are adequate, and the supplier continuously meets the requirements set out in these processes. Thus, as long as the supplier acts according to their own QMS (I assume you didn't qualify a supplier who doesn't have a QMS at all...), and your supplier qualification process has (in the past) resulted in this supplier -- including their QMS -- being acceptable, I see no regulatory / QA / control failure. If you have any reasons to suspect that this supplier's performance is less than adequate, I recommend you have another look at their qualification (as your supplier) process records, and maybe reconsider their status.

I do agree that since it's an outsourced part, the applicable controls would be Purchasing controls. In that sense, your main concern should be -- does this part meet its specifications in full? And, how & to what extent would you verify that? Whether or not your own internal processes (e.g. non-conforming product) should be involved as well, depends, IMO, on whether the defect was discovered at the supplier (before ever getting to you), or was it your own inspection/testing that revealed it.

Cheers,
Ronen.