NCMR Rework

[MedtechQuality]

Hello all,

I’m looking for some clarity on ISO 13485:2016, section 8.3.4.

If I receive a component from a supplier that’s missing a dowel pin or screw, I place it under NCMR. If the disposition is rework, can I create step-by-step rework instructions that aren’t part of our existing documented procedures (as the component is a supplier-manufactured one), even if the steps are straightforward and bring the part back into spec?

Does 8.3.4 require that " The organization shall perform rework in accordance with documented procedures that takes into account the potential adverse effect of the rework on the product. These procedures shall undergo the same review and approval as the original procedure."

In other words, would handling it the quick way lead to an audit finding?

Thanks in advance

 

[Bev D]

I read the quoted section to mean that your documented procedure for rework (that is different from the original reviewed and approved procedure) to require review and approval commensurate with the original procedural reviews…so no you can’t - and more importantly you shouldn’t - go solo and write a rework procedure that is not reviewed and approved by others…

Sorry but the ‘speed’ of the rework is not relevant. And that is true in any industry

 

[yodon]

Since you're reworking a component, I presume there are no original procedures, other than maybe a drawing. But as @Bev D notes, you still need documented and approved procedures. Doesn't have to be a volume of instructions. One page saying what's being done, why it doesn't adversely effect the product, and a signature. (If you have a signed-off drawing, at least get approval from whoever approved the drawing.) As part of your impact assessment, consider that the material for the dowel or screw may be different from what the supplier would have provided (i.e., could lead to unexpected degradation, etc.). Evidence of the rework should go into the production record.

 

[ChrisM]

Since you're reworking a component, I presume there are no original procedures.....

One of my former bosses was very clear about this - if you do not have an original procedure to follow, then you are repairing rather than reworking. That is a completely different ball-game and first begs the question "Are you permitted (by the supplier/manufacturer) to carry out repairs?"

 

[Billy Milly]

Well... if you respect the requirement that the procedure should be approved by the function responsible for the original procedure, it should be approved by the supplier.

 

[MedtechQuality]

if I receive a component from a supplier that’s missing a dowel pin or screw, I place it under NCMR. If the disposition is rework, can I create step-by-step rework instructions that aren’t part of our existing documented procedures (as the component is a supplier-manufactured one), even if the steps are straightforward and bring the part back into spec?

Even though this is a supplier-provided component, can we still perform the rework if I create the rework instructions and have them approved by our internal cross-functional team? And once those instructions are approved, doesn’t that make the document a controlled procedure / documented procedure?

@Bev D @Billy Milly @yodon @ChrisM Thank you for sharing your feedback.

 

[Bev D]

Maybe…is the part your custom design? Or is it designed by the supplier to your requirements. Then your design people should have the expertise to understand the risks. If it is an ‘off the shelf’ part then maybe not.

But the bigger question is: why wouldn’t you just return the part to the Supplier to replace or rework? This is what most companies would do…

 

[ChrisM]

Even though this is a supplier-provided component, can we still perform the rework if I create the rework instructions and have them approved by our internal cross-functional team?

You will (technically) need to get the supplier's approval to perform the work in addition to any internal approval that you deem necessary.
An example: One medical device company where I worked in the past: our supplier forgot to affix some particular labels to some of the products in a delivery. They could have sent us the labels to apply ourselves but we argued the point I made earlier - we were not authorised to perform this task and our staff had not been trained to do it - no matter how simple a process it may seem. We were left with 2 options - return the parts to our supplier, or the supplier was to send someone to our site with the missing labels, and affixed them themselves. They chose the latter method.

 

[Bev D]

The rule exists for a very good reason - many many catastrophic events due to ‘unintended consequences’ and rework performed without risk review and in many cases some kind of validation. No offense but you are not smarter than history or physics…

 

[Jtavo]

If you attempt to fix it you'll be by-passing their QA as well as yours. The supplier is to conform to a requirement and they need to know - dont take on their errors / defects; it'll become yours, and you will have paid them for the pain too..