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Are detailed engineering requirements Design Inputs or Design Outputs
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Are detailed engineering requirements Design Inputs or Design Outputs
Are detailed engineering requirements Design Inputs or Design Outputs
Are detailed engineering requirements Design Inputs or Design Outputs
Are detailed engineering requirements Design Inputs or Design Outputs
Are detailed engineering requirements Design Inputs or Design Outputs
Are detailed engineering requirements Design Inputs or Design Outputs
Are detailed engineering requirements Design Inputs or Design Outputs
Are detailed engineering requirements Design Inputs or Design Outputs
Are detailed engineering requirements Design Inputs or Design Outputs
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design inputs and outputs, engineering standards and specifications
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  Post Number #9  
Old 14th June 2018, 02:43 AM
sagai

 
 
Total Posts: 1,121
Re: Are detailed engineering requirements Design Inputs or Design Outputs

It might be of my hazy memory, I cannot recall however any project when the specifications, requirements were available at the time of they would have been needed for the design activities. For Concept paper, yes, that is mostly available with a vague content of the things to be developed.
More or less 100% of the cases the specifications, requirements mature over the time with the design till it is ready for production/release (or when designers and managers had enough of doing that design ).
Further, it could also be that specification, requirements crafted after the design had been released.

So, for specification and requirements I tend not to classify those as inputs.

Cheers
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  Post Number #10  
Old 14th June 2018, 01:40 PM
Mark Meer

 
 
Total Posts: 805
Re: Are detailed engineering requirements Design Inputs or Design Outputs

Quote:
In Reply to Parent Post by sagai View Post

...requirements mature over the time...
...So, for specification and requirements I tend not to classify those as inputs.
I'm not sure I follow your logic.

True, there can be some dynamic interplay between requirements and outputs throughout the design and development process, and overtime. ...but could you not say the same thing for just about everything in the process (customer requirements, risk files, market data...)?

This being the case, I'm curious: what would you consider design inputs, if requirement specifications are ruled out on the basis that they change?
Thanks to Mark Meer for your informative Post and/or Attachment!
  Post Number #11  
Old 14th June 2018, 02:14 PM
sagai

 
 
Total Posts: 1,121
Re: Are detailed engineering requirements Design Inputs or Design Outputs

My logic does not matter much on these.
That's said in 21CFR820.3 f,g and j .

Actually yes, ISO13485 is saying slightly differently.

Cheers
  Post Number #12  
Old 14th June 2018, 02:47 PM
david316

 
 
Total Posts: 25
Re: Are detailed engineering requirements Design Inputs or Design Outputs

21CFR820.3 is not clear as it talks about specifications as outputs. The problem is the term specifications mean different things to different people/companies. I don't think they mean engineering specifications in the form of requirements as this isn't part of the DMR. I think these are a design input. I think they mean specification in the context of drawings, material specification, electronic parts etc.
Thanks to david316 for your informative Post and/or Attachment!
  Post Number #13  
Old 14th June 2018, 03:04 PM
sagai

 
 
Total Posts: 1,121
Re: Are detailed engineering requirements Design Inputs or Design Outputs

It is all up to you of course.

I sleep better to know that if there is a fix needed let's say 10 years from now on that particular revision of the device than the developers will find all necessary information in the DMR to quickly and effectively fix the problem they have.

I am still looking weird for saying that the specification and requirement set that is ready more or less by the time the design ready for serial production would be something to call as input for the design.
  Post Number #14  
Old 14th June 2018, 04:59 PM
qualprod

 
 
Total Posts: 107
Re: Are detailed engineering requirements Design Inputs or Design Outputs

Maybe the confusion is for the terms.

If you have been involved in engineering projects, maybe have seen/managed these documents.
When any Engineering project is starting
you need: (they are inputs)
Basic engineering drawings
Plant conditions (geographical place, altitude, temperature,etc.)
Design basis (materials allowed, standards to comply, regulations)
General requirements of clients
Vendor drawings
Previous engineering documents (references)
special format of drawings (DXF,DGN,DWG)

Then you develop the engineering and
have the outputs:

Detailed drawings
Bill of materials
equipment specifications
material specifications
equipment purchase orders
Isometrics,etc.
stress analysis
pressure vessel calculations
etc.

Hope this helps
Thank You to qualprod for your informative Post and/or Attachment!
  Post Number #15  
Old 14th June 2018, 07:17 PM
Chromehounds

 
 
Total Posts: 6
Re: Are detailed engineering requirements Design Inputs or Design Outputs

Quote:
In Reply to Parent Post by david316 View Post

Hello,

Often with a complicated project, the user needs will get broken down in more and more detailed requirements. For example for a medical device you may end up with specific electronic, software or mechanical requirements. Are the detailed engineering requirements (which some people call engineering specifications) design outputs? Note, I am not talking about drawings etc, these are detailed requirements and are written as requirements which are then ultimately verified.

Thanks
If I understand you correctly, in your last sentence, you are referring to both input and output. Detailed system requirements are Input, verifying the detailed requirements is Output (test procedures).
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