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Engineering change validation - Companies that have no design responsibility

A

Andrews

#1
#1
Is this applicable to companies that have no design responsibility? Only validation we do is PPAP
 
QMS for Medical Device Companies
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Marc

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
#2
If you are not design responsible you are not responsible for design validation. However, in some cases you *might* be part of that process as a 'guest' of the party responsible for the design.
 
B

Bill Ryan - 2007

#3
#3
Marc said:
If you are not design responsible you are not responsible for design validation.
Click to expand...
I fully agree. However - regarding an engineering change, there have been instances where we have asked for an engineering change and our customer required us to "do" the the part validation. That meant we had to "buy time" on our customer's robots or go to another source to perform the testing. I don't know how common a practice that is, but it has happened.

Just FWIW
 
R

remsqa

#4
#4
Design Validation

Dear all

As i know the Design validation should be done with in two working weeks.From the date of change of design.

For a company of design responsiablity they have to do the full design validation as per their DESIGN verification plan.

For whom the design is not the company responsiablity they should do the process revied and conduct PPAP to conclude the Design validation.


REGARDS

R.L.SATTHISH KUMAR

ANY VIEWS PL REPLY
 
Marc

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#5
#5
remsqa said:
As i know the Design validation should be done with in two working weeks.From the date of change of design.
Click to expand...
I don't know of any specific time requirement.
For a company of design responsiablity they have to do the full design validation as per their DESIGN verification plan.
Click to expand...
Yes.
For whom the design is not the company responsiablity they should do the process revied and conduct PPAP to conclude the Design validation.
Click to expand...
Yes.
 
DeeDeeM

DeeDeeM

Starting to get Involved
#6
#6
Well, if the company is not product design responsible will not do product design validation. But to produce this product of the customer the organisation has process design responsibilities. So process desigh validation is needed, I guess. And it should to be agreed with the customer, I guess
 
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