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

[RCW]

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.

[Mikishots]

In Reply to Parent Post by RCW

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.

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?

[RCW]

In Reply to Parent Post by Mikishots

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?

"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.

In Reply to Parent Post by Mikishots

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

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.

[RCW]

In Reply to Parent Post by Mikishots

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.

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.

[Ronen E]

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.

[somashekar]

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.

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.

[RCW]

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.

[somashekar]

In Reply to Parent Post by RCW

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.

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.