This has been answered twice and both answers are absolutely correct.
If you don't understand; ask and that way you can help everybody.
Oh J0anne, here we go then, I appreciate any light you can shed on this for me.
Questions
Firstly, what does URS mean, I did not see that defined anywhere
The part of the regulation I am struggling with the most, just to be clear, is: "Design output procedures shall...ensure that those design outputs that are
essential for the proper functioning of the device are
identified.
What does identified mean? ie - does it mean that the essential outputs must
just be on a design output (such as a drawing and/or procedure), or does it mean that the essential outputs must be on a design output
and differentiated from the other non-essential design outputs.
Also what is the purpose of this essential design output identification. How is it used for the benefit of monitoring those essential outputs? I don't see that connected up anywhere else in the regs. If it doesn't effect anything else in a positive way, what is the purpose of it? I found a potential answer to that and I was gonna post a link to it, but I guess I can't do that, so I will just post the relevant info below and italicize it.
The Commonalities of Risk Management and Design Verification, Design Validation and Process Validation
Written by: Edwin Bills - Bilanx Consulting
OK, now the device is designed and you just have to get through that pesky Design Verification and
Design Validation process before you put the device on the market, and get some income after all the
design effort. But, really what is necessary to get through these steps?
Essential Design Outputs
The FDA has a requirement in Design Outputs (21 CFR 820.30 d) to “ensure that those design
outputs that are essential for the proper functioning of the device are identified”. In discussions with
Office of Compliance, personnel indicated that risk management processes are used to identify these
essential outputs. The outputs are those identified as Risk Control measures. So the requirement is
to identify in design output documents those risk controls for the purpose of communicating which are
essential to the functioning and safety of the device.
Why are the essential outputs important to this discussion? The identified Essential Outputs (EDO)
are those items that will be included in the Design Verification, Process Validation and Design
Validation activities. Each of the Risk Control measures (EDO) must have a record in the Risk
Management File that indicates the EDO has been verified for implementation, that the estimated risk
following implementation is verified as correct, and in the process to produce the device, the EDO has
been reviewed for Process Validation requirements.
Manufacturers need a mechanism to communicate the EDO to those internal and external
organizations that have an impact on the EDO so that the product produced is controlled within its
specifications. If the resources are focused on those truly important characteristics, then we should
have fewer recalls and Corrective Actions. Usually component specifications and drawings are
marked with information that indicates EDO and are accompanied by information communicated to
those responsible, in both internal and external organizations for those items to indicate that these
items have a major impact on the device safety.
In this document the author instructs that this identification of essential outputs should be done using risk in the risk documentation, and the measures put in place to ensure the essential design outputs would also be managed within the risk process. However, the author of that article lost me a bit midway, i.e, didn't really understand how "the outputs are those identified as Risk Control measures". Seems like to me that the output is an output, and what you do to mitigate risk associated with it is the risk control measure.
Lastly, earlier in this thread, Statistical Steven stated that the DHR, which means Device History Record to me, can be used for this purpose. That didn't make sense to me either, as there could be hundreds or even thousands of essential design outputs, and not all would be captured on the DHR. For example, if the dielectric strength of an insulation is essential, the dielectric strength on incoming material may be guaranteed on the certificate of conformance from a supplier, but that dielectric strength wouldn't necessarily be tested on each unit and documented for each unit or batch on the DHR.
Thanks in advance for your help, sorry for the long post, and sorry to everyone and the forum operator for posting my email address, didn't know that was such a no-no but I understand now that could lead to private discussions that don't benefit anybody else.