Design Verification Documentation

racglobal

Involved In Discussions
#1
Hello everyone,

I understand there are different design verification methods. CAD drawings/PCB drawings are one form of design output. To verify the outputs against the inputs, it is usually an inspection. How does one write a design verification report to demonstrate the design output (design drawings) meets the design input requirements? I've only seen design verification report for tests. How does one write a report that summarizes an inspection of a drawing? I'd appreciate any insight.


Thanks.
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Good day racglobal,

A report can contain descriptive and/or numerical information. Inspection of a part against the drawing(s) will usually include dimensional checks, but the notes should also be addressed. A note that says "Cable ties 12345 attached at point A, B and C" Can have a line n the report saying "Cable ties 12345 attached at points A, B and C - Present" which indicates the required BOM part was verified to be present. If the print calls out for a material type, the report can refer to a Certificate of Analysis; if a special requirement for something like RoHS compliance is included in the notes, a line item confirming RoHS certificate of compliance can be included in the report.

Line by line by line, the drawing's features have been identified by circles with numbers in them that correspond to line items on the inspection report. This is called a "bubbled pint." It is included as a reference along with the inspection report and mentioned certificates as required, as a package showing your initial product has been verified to conform to requirements.

Is this what you wanted to know?
 

Ronen E

Problem Solver
Staff member
Moderator
#3
How does one write a design verification report to demonstrate the design output (design drawings) meets the design input requirements? I've only seen design verification report for tests. How does one write a report that summarizes an inspection of a drawing?
You don't design-verify individual design outputs, you verify the design output as a whole. You go through individual design inputs, and look for supporting evidence in/by the design outputs, wherever you can find it. It may be one or more detail from a drawing, multiple details from several drawings, or other things.
You don't "verify a drawing" (design-verify). One might inspect a drawing, but that's more of an engineering check, part of the actual design effort.
A report can contain descriptive and/or numerical information. Inspection of a part against the drawing(s) will usually include dimensional checks, but the notes should also be addressed. A note that says "Cable ties 12345 attached at point A, B and C" Can have a line n the report saying "Cable ties 12345 attached at points A, B and C - Present" which indicates the required BOM part was verified to be present. If the print calls out for a material type, the report can refer to a Certificate of Analysis; if a special requirement for something like RoHS compliance is included in the notes, a line item confirming RoHS certificate of compliance can be included in the report.
That's verifying the realization against the drawing, not verifying the design ("verifying the drawing", ugh) against the design input.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#4
Thank you Ronen, please feel free to give a better example than I did. I usually stick to other subjects because of this.
 

Watchcat

Trusted Information Resource
#5
You don't design-verify individual design outputs, you verify the design output as a whole. You go through individual design inputs, and look for supporting evidence in/by the design outputs, wherever you find them
I agree with what you are saying, but I don't think I would describe this as verifying design outputs "as a whole." Clearly verification involves individual inputs and outputs, nothing holistic.

I think your key point relative to racglobal's question is that verification is driven by inputs, not outputs. If you have outputs that don't verify any inputs, not a problem. If you have inputs that are not verified by any outputs (whether they are drawings or test results or whatever), you definitely have a problem.

I think validation is what deals with the design "as a whole."
 
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akp060

Involved In Discussions
#7
If you have outputs that don't verify any inputs, not a problem.
But shouldn't be all outputs (DO) be verified against their inputs? At least that is what the design control guidance says. And if any DO does not satisfy any input how do you map that to a Product Requirement/User requirement. Please cite an example if convenient
 

Tidge

Involved In Discussions
#8
But shouldn't be all outputs (DO) be verified against their inputs? At least that is what the design control guidance says. And if any DO does not satisfy any input how do you map that to a Product Requirement/User requirement. Please cite an example if convenient
There was a subtle point in the post by @Watchcat: All inputs require verification that they are satisfied, and even though inputs must be allocated to design outputs there are often certain elements of design outputs that don't derive from specified inputs. Typically the first order of design inputs is to satisfy patient/user needs; higher orders of design inputs can address things like manufacturability and purchasability of raw materials. These higher order inputs can often go unspecified; that is, they won't necessarily be spelled out in a design inputs requirement document...it all depends on the maturity of the organization.

For example: aesthetic choices (e.g. color of wires) are often included on certain design outputs but are usually not directly satisfying a design input whereas the gauge of the wire is likely satisfying the current-carrying capacity of a cable assembly. Engineers often have legitimate reasons for most of the design outputs, but not all of the design choices would have been mandated by the input requirements. It has been my experience that it is best to specifically identify and review the elements of design outputs which are specifically allocated to satisfy design inputs, and also to review the completed design output for suitability for all the "unspecified inputs".
 

Ronen E

Problem Solver
Staff member
Moderator
#9
But shouldn't be all outputs (DO) be verified against their inputs?
No. The Design Output (singular), as a set, must be verified, but there's no requirement to verify individual design outputs (plural).
At least that is what the design control guidance says.
Quote?
if any DO does not satisfy any input how do you map that to a Product Requirement/User requirement.
Where is the requirement to "map" every individual design output to specific design inputs?
 

akp060

Involved In Discussions
#10
No. The Design Output (singular), as a set, must be verified, but there's no requirement to verify individual design outputs (plural).

Quote?

Where is the requirement to "map" every individual design output to specific design inputs?
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I hope I killed three birds with one shot! Excuse me if I have left anything unanswered. Mapping is a logical approach to demonstrate compliance with the above. If we do not map User need(s)>Design Input(s)>Design Output(s) that such and such output correspond such and such input and that in turn to such and such requirements we end up having a design that is to some extent unverified either in terms of design output or user requirements. The end goal is always justifying the indications for use/intended use while neither overdoing or understating, which is always achieved by mapping throughout the design process
 
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