DQ (Design Qualification) requirements for standard devices

B

BenBoso

#1
Dear colleagues,

I have a question regarding whether a DQ is required for standard devices or not.

My company wants to purchase a fully automated pipetting robot, and I was asked to write the specification book for it. The device is a standard device offered by a manufacturer and does not require any custom changes for our needs.

The devices specifications stated in their technical description match our needs.

I was wondering if we still need to write a full specification book - URS or if we, for the functional description, could just refer to their specifications and description.

I would of course add any requirements regarding, documentation, enviroment, etc to the specification book, but for the functional part I would just go with the manufacturers description of its device and its specifications.

What do you think, would this be a legit way to do it ?

Thanks in advance,
Ben
 
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B

BenBoso

#3
Thanks for your reply, Joanne. I already thought that I cant just declare that they meet our needs by just referring to their description.

So Ill get to work, have a good one.
 
M

MIREGMGR

#5
You can't just say their their description meets your needs, you have to show how it meets this. Use their spec to devise your own URS and follow your DQ procedure to make sure input = output.
Input = output is a design control requirement, for products.

Is this robot to be a product, or will it be an item of production equipment?

I don't know of a "shall" that I understand to mean that such a documentation extent is required for production equipment. If your engineers and production and finance people have decided the item is preferred, fine. Though of course you do need to document how processes and product specification compliance are related, and changes to those processes, there's no requirement for someone to detail the engineering analysis of other reasons why a particular item of production equipment may be desirable or economical.

Frequently, of course, production equipment is chosen for reasons that are not directly related to quality and to product safety and effectiveness. It might run faster, or require less labor, or the old one might be worn out and this one has the best replacement cost. That analysis doesn't have to be documented.
 
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