Design Traceability Matrix Requirements

A

allendavid

#1
We know the design traceabiity matrix is very important. But if we just take some activities in whole design, just re-design the schematic and layout based on origina schematic and layout, no verification, no validation, should we do design traceability matrix? All schematic and drawing are reviewed and approved by customer, no intended use, no product requirements, should we do design trace?
 
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somashekar

Staff member
Super Moderator
#2
Re: Design Traceability Matrix

We know the design traceabiity matrix is very important. But if we just take some activities in whole design, just re-design the schematic and layout based on origina schematic and layout, no verification, no validation, should we do design traceability matrix? All schematic and drawing are reviewed and approved by customer, no intended use, no product requirements, should we do design trace?
Design is your service and customer's responsibility ~~~
 

somashekar

Staff member
Super Moderator
#4
Re: Design Traceability Matrix

Thanks for your comments. Could you more specify my questions?
In the case of this as well as the DHF, you are not associated with the design ownership. Between you and your customer, if he wants you to maintain any of these and you have a system to manage them, it could be done.
An other aspect is the archive of learning that you can build when you maintain the DHF, but again this will be only to the extent you have been provided inputs by your customer.
 
A

allendavid

#5
Re: Design Traceability Matrix

In the case of this as well as the DHF, you are not associated with the design ownership. Between you and your customer, if he wants you to maintain any of these and you have a system to manage them, it could be done.
An other aspect is the archive of learning that you can build when you maintain the DHF, but again this will be only to the extent you have been provided inputs by your customer.
If we and customer have agreement that DHF can be done by customer, what can i answer when FDA audit?
 
A

allendavid

#6
Re: Design Traceability Matrix

If we and customer have agreement that DHF can be done by customer, what can i answer when FDA audit?
I am still a little bit in trouble with this question, who can support me?
 
Last edited by a moderator:
S

Sybarite

#7
Re: Design Traceability Matrix

OP needs to clarify the question before we can help with advice. I'm not quite sure I follow.
 
A

allendavid

#8
Re: Design Traceability Matrix

Maybe My explanation is not enough.

Again this question.

If we just do some re-design work, no verification, no validtion, after we finish the schematic, layout, and approved by customer, directly go to customer for manufacturing. in this circumstance, shall we do design traceability?
 
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