Design input/output traceability for mechanical parts

shimonv

Trusted Information Resource
#1
Hi Fellows,
I'd like to hear your thoughts on linking design output to design input.

With software it's straight forward because the IEC 62304 is very clear about the requirement for traceability. Also, and usually, each code block is designed to meet a specific design requirement. The traceability matrix is one for one.

With hardware (especially mechanical components) it's different. Each design input is linked to multiple drawings and assemblies, and there is a lot of overlap (same set of part numbers could address multiple input requirements).

I've seen a bunch of approaches for handling linkage between mechanical components and design inputs.
It is a special challenge for small companies who do not have software tools for managing design QA.

What is your best practice?

Thanks,
Shimon
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
I believe that the concept of trying to trace back individual physical components to design inputs is wrong. There is no such regulatory requirement that I know of. Maybe it really is a result of the SW development mindset, which is becoming more and more prevalent in the last decade or two.

The actual requirement is that the whole of the Design Output (plural) satisfies the whole of the Design Input. It may, in some instances, be of value to trace certain Design Output subsets (e.g. a subset of drawings or maybe even a single drawing) to a certain Design Input requirement (or requirements subset), but I wouldn't obsess about it just for the sake of appearance.
 

somashekar

Staff member
Super Moderator
#3
You would not get a better answer than the #2 above.
Ex: If the input for the design of a patient monitor cable says that it must be long enough to be able to reach the patient applied area from the monitor...... then the design output for the cable could be saying length = 12' (+/- 3")
This output comes from a lot of review and verification activities.
There could be other inputs about the cable coming from regulatory as well, leading to more design considerations.
If your company decides that the cable color will be blue, then the design output will indicate a certain pantone shade of blue for the cable, which will help the cable manufacturer to make and your inspection to check and pass..... and so on
 

shimonv

Trusted Information Resource
#4
I believe that the concept of trying to trace back individual physical components to design inputs is wrong. There is no such regulatory requirement that I know of. Maybe it really is a result of the SW development mindset, which is becoming more and more prevalent in the last decade or two.
Thanks Ronen. That has been my thinking as well, but other companies are doing it and that creates a new "norm". I don't want to force R&D to do something that has little to no value.

Somashekar - the examples you gave are for externally visible specs.

Ronen & Somashekar: how will you handle a reviewer who comes and looks at the design input requirements and than asks for an evidence for a certain requirement that was implemented in internal mechanical sub-assembly?
I could argue that traceability in the h/w layer is not explicitly required (not very strong argument nowadays) and/or point to the master V&V plan having made sure that it traces tests to a specific requirement.
Is there anything else that can be done?

Shimon
 

somashekar

Staff member
Super Moderator
#5
Hi Shimonv.
I still prefer examples to say rather than detail.
If the design input requirement is that the emissions of the vehicle must meet BS IV standards, tats it.
What other design and developments are made, modified or otherwise invented is not listed into the design input requirements.
Your approved tests of the vehicle emissions proving that the BS IV standards norms are met or exceeded is the design output proof (meeting input requirements) and what engine you have finally built (Its design specifications, Bill of materials, Drawings, etc etc ...) are the design outputs meeting input requirements.
I guess you are making a very exhaustive list calling it input requirements, which is not the intent of the design and development process.
 

shimonv

Trusted Information Resource
#6
Thanks. The design input is not very exhaustive.
Let's take for example infusion pump. The design input requires to have the ability to detect occlusion in the administration set. This requirement is implemented the development of a flow control sensors. So, you would present the bench test report for occlusion detection and say - "see, I meet the input requirement" without actually pointing out to the electro-mechanical sub-assembly which is the actual design output.
I am with you, but I can see some auditors arguing to the contrary.
 

somashekar

Staff member
Super Moderator
#7
Just reversing the order for a reviewer response... (I assume you are referring to the external reviewer in a audit situation)
If the question is "How do you meet the requirement of occlusion detection ?
Then...
"We have a flow control sensor sub-assembly which is able to detect blockage or closing in the administration set thereby triggering the stopping of the infusion." (design consideration)
The bench test report for occlusion detection is the verification / validation report of the same.
I can't see a case of argument...
 

Ronen E

Problem Solver
Staff member
Moderator
#8
other companies are doing it and that creates a new "norm"
This is called "regulatory creep" and we must all resist it if we want reason to rule.

how will you handle a reviewer who comes and looks at the design input requirements and than asks for an evidence for a certain requirement that was implemented in internal mechanical sub-assembly?
This is rather easy if Design Control is implemented while keeping in mind the rationales and intentions behind it. When Design Verification is planned and executed, it should follow the Design Input requirements. I usually make a note at the top of each verification item/activity, which Design Input requirement is being verified. If this is followed all the way through to the summary report, it becomes easy - you take the requirement ID from the Design Input (any that a reviewer is interested in) and you look for it in the Design Verification summary report. If you have many requirements you can create a table/matrix/index that lists the Design Input requirements' IDs and the Design Verification sections that address each; however, this is not even necessary if the document is searchable.
 

Ronen E

Problem Solver
Staff member
Moderator
#10
Just reversing the order for a reviewer response... (I assume you are referring to the external reviewer in a audit situation)
If the question is "How do you meet the requirement of occlusion detection ?
Then...
"We have a flow control sensor sub-assembly which is able to detect blockage or closing in the administration set thereby triggering the stopping of the infusion." (design consideration)
The bench test report for occlusion detection is the verification / validation report of the same.
I can't see a case of argument...
I fully agree, and would like to add: The risk management file is a good place to capture such considerations.
 
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