SOP for How to Write a Specification for Raw Materials and Finished Good

T

terry31575

#1
I am building a FDA 820/ISO 13485 quality system. I am working on an SOP for how to write a specification for raw materials and finished good. Do I need to provide justification for each test and acceptance criteria that is listed on the specification?
 
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M

Meatgrinder

#3
If you look at an audit check-list you may find your answer. I looked and found several questions related to acceptance criteria. Google ISO 13485 7.1q3 audit checklist. i.e.

In planning product realization, the organization shall determine the following, as appropriate:
a) quality objectives and requirements for the product;
b) the need to establish processes, documents, and provide resources specific to the product;
c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;
d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4).

Not sure if this helps but if it does...I'm happy to have helped :)
 

Ronen E

Problem Solver
Staff member
Moderator
#4
I am building a FDA 820/ISO 13485 quality system. I am working on an SOP for how to write a specification for raw materials and finished good. Do I need to provide justification for each test and acceptance criteria that is listed on the specification?
Hi,

I'm assuming you refer to testing in routine production (not R&D).

The justifications for such tests are developed during the R&D phase, and are translated into specifications and instructions that will be used in production, during the Design Transfer (actually, in some companies it begins in Design Validation). Hence, the requirements to document those justifications would - IMO - belong in your Design Control SOPs, and more specifically in the Design Validation and Design Transfer procedures. The justifications themselves belong (again, my opinion) in the DHF or it's 13485 equivalent.

Cheers,
Ronen.
 
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