Difference between DMR procedures vs. QMS procedures?

S

sjqlty

This is probably a dumb question, but I'm going to ask it anyways.

Can anyone explain to me if the procedures that are used to manufacture a device (those in the DMR) are a subset of the Quality Management System? In other words, when someone refers to "Quality System processes" would this this include those DMR manufacturing procedures specific to a product (such as the assembly SOP), or is it seen as being separate?

For instance: 820.100.2 states: "Investigating the cause of nonconformities relating to product, processes, and the quality system;" What processes differ from those in the the quality system?

Thanks!
 
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Y

yodon

Leader
Super Moderator
No dumb questions...

Others may have a different opinion but to me, the QMS (and associated procedures) are those that define how you run your business. The DMR (and associated procedures) are how you develop a particular product. So the DMR is driven by the QMS.

I tend to segregate the product-specific things from the QMS (again, as they are all implemented through / as a result of the Quality System).

A product-related process non-conformity would maybe be the lack of approval on a batch record. The product may be ok but the process was non-compliant. A QMS-specific process non-conformity would be if you failed to conduct a Management Review when you said you would.
 
Ronen E

Ronen E

Problem Solver
Moderator
sjqlty said:
This is probably a dumb question, but I'm going to ask it anyways.

Can anyone explain to me if the procedures that are used to manufacture a device (those in the DMR) are a subset of the Quality Management System? In other words, when someone refers to "Quality System processes" would this this include those DMR manufacturing procedures specific to a product (such as the assembly SOP), or is it seen as being separate?

For instance: 820.100.2 states: "Investigating the cause of nonconformities relating to product, processes, and the quality system;" What processes differ from those in the the quality system?

Thanks!
Click to expand...

A nonconformity relating to the quality system could be, for instance, failing to have a documented QMS procedure that is prescribed in the regulation.

A nonconformity relating to a process could be any instance where an established (documented) process was not followed as prescribed.

There may be some overlap between nonconformities relating to processes and those that relate to the quality system, but these are not identical sets.
 
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