Identification of Products and Materials (obtaining sub components from over seas manufacturers)

R Walsh

Registered
"identification of Products and Materials" procedure. Does this procedure cover only how we will identify our products once produced? or does it deal with tracking our products all the way back to the raw materials?

I ask this because for some of our products we buy components and assemble them. So in this scenario would the identification of the purchased components be covered in the "Purchasing" OP? or do I have to state how we identify our products from start to finish in this OP? Or does the identification start at when we receive the purchased components? Or do I have to get the data on how some of our over seas manufacturers identify the material they use?

Any info or advice is greatly appreciated!
 

yodon

Leader
Super Moderator
What clause in 13485 are you trying to address?

I'm assuming 7.5.9, but want to be sure. Presuming so, you need to consider risk. If you have an implanted product then traceability back to the raw material is going to be very important. If you have a non-contacting device that incorporates a screw, traceability isn't (likely) important.

This would span purchasing (source) through manufacturing (associating with the builds / lots).

Where you describe the procedure is not a concern as long as everyone understands and follows.
 

R Walsh

Registered
What clause in 13485 are you trying to address?

I'm assuming 7.5.9, but want to be sure. Presuming so, you need to consider risk. If you have an implanted product then traceability back to the raw material is going to be very important. If you have a non-contacting device that incorporates a screw, traceability isn't (likely) important.

This would span purchasing (source) through manufacturing (associating with the builds / lots).

Where you describe the procedure is not a concern as long as everyone understands and follows.
Yes, 7.5.9 and it is a class 1 non contact device, for example we buy sub components for our LED headlight, and all we have to do is assemble. The battery that we sell with the headlight as a package, already comes assembled and everything.

So for the battery / headlight would traceability back to raw components be that important?
 

Sidney Vianna

Post Responsibly
Leader
Admin
Any info or advice is greatly appreciated!
You are mixing product identification with traceability. These are separate issues. Product does include components and they must be identified somehow; otherwise how would you properly specify what you are purchasing from suppliers.

Traceability is distinct and separate from product identification. Apparently you are trying to create separate procedures to address the different clauses of the 13485 standard and that approach tends to lead to disconnected, patchwork documentation.
 

yodon

Leader
Super Moderator
So for the battery / headlight would traceability back to raw components be that important?
The main objective with traceability is to limit your impact in the event of things going wrong. If you have something in the field that goes bad and you determine the cause to be a specific component, if you have no traceability to where that component came from, you may need to take action on every unit in the field. If you have traceability to the component lot (assuming the lot is bad or potentially bad), then you need only take action on units on which that lot of components was used.

We can't answer your question because we don't know the criticality of the light (assume low risk since class I) or the characteristics of the components or a handful of other considerations. You need to make a risk-based decision, weighing the considerations as to the depth of traceability. My guess is that, at best, you want traceability back to the lots of each of those components.
 
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