Verification & Validation (V&V) Traceability - What are the benefits and limitations?

D

Donald Duck

Who can tell me what is the traceability method for V & V, and what is the benefits of the method and limitations?

some advices?

:bonk:
 

Wes Bucey

Prophet of Profit
Marc said:
What is V & V?
I would suppose he is referring to
Verification & Validation
but I haven't a clue how to relate that to "traceability."

How about elaborating on the circumstances surrounding your V&V, Donald Duck? Do you mean "Verification & Validation?"
 
D

Donald Duck

I fess here: V & V is --- I dont know!

Last night I received an email with 5 interesting questions. I post all of them here, not only for the answers, but also wanna initiate some discussion.

Some threads I can provide is: these questions came from a medical equipment manufacturer.
 

Randy

Super Moderator
V&V has lent itself to a whole world of interpretation.

Verification, as I understand and preach, is the process(s) necessary to ensure that the product (service) design (components/sub-components) meets or falls into the defined parameters. In aviation maintenance this would include the operational checks of sytem/sub-system components.

Validation, as I understand and also preach, is the process whereby we show through test/operation that the product (service) is capable of meeting all requirements. I equate this to the flight testing of aircraft after maintenance.

Some things cannot be Validated until operated..like the Space Shuttle, or more recently the Mars Rovers.
 

Wes Bucey

Prophet of Profit
Randy said:
V&V has lent itself to a whole world of interpretation.

Verification, as I understand and preach, is the process(s) necessary to ensure that the product (service) design (components/sub-components) meets or falls into the defined parameters. In aviation maintenance this would include the operational checks of sytem/sub-system components.

Validation, as I understand and also preach, is the process whereby we show through test/operation that the product (service) is capable of meeting all requirements. I equate this to the flight testing of aircraft after maintenance.

Some things cannot be Validated until operated..like the Space Shuttle, or more recently the Mars Rovers.
Pretty much gibes with my understanding of V&V. The question on the table is "tie it to traceability method."

Maybe I need stronger coffee, but unless we are just talking about the record-keeping of those V&V activities, what other method could there be? Am I looking for something more than is [to me] obvious?
 
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Al Rosen

Leader
Super Moderator
Donald Duck said:
Who can tell me what is the traceability method for V & V, and what is the benefits of the method and limitations?

some advices?

:bonk:
Where is the data?
Who did the verification?
When was it done?

Ditto for validation.
 
W

wrodnigg

Traceability is (IMHO) not a kind of "method", which has benefits or limitations. Traceability is part of a validation process.

Let us assume, we use the V-model for the validation process, then we have the following phases for the validation process:

Code:
    user requirements     <--performance qualification
              \                 /
       functional specs <--operational qualification
                \            /
         design specs <--installation qualification
                  \        /
                 system build

As I mentioned in an other thread (14971 & lifecycle) we are verifying the design specs (DS) in the IQ, the FS in the OQ and the UR in the PQ.

The complexity of testing in the different Q-Phases should be based on the risk of the requirements/specs. We are moving forward from risk assessment to risk management (ISO 14971), therefore risk management should be considered throughout the whole validation procerss.

And now for the traceability thing:

One should develop the FS based on the UR and the DS out of the FS.
And the differen requirements and specifications should be traceable through the whole process:
UR 3.1 is considered in FS 4.1 to 4.4 and therefore we need DS 3.5 to 4.12
Based on the risk of each specification you have certain tests in the IQ, OQ, PQ phases, which validate these specs. And one should be able to trace each requirement/spec to a test case. That is, what is called traceability in V&V.

I use a matrix (Excel sheet), which shows the traces of each requirement (and the risk) through the validation process.

This helps avoiding to forge some requirements and to put on tests, which are not needed.

I hope my explanation is somehow clear. Just ask, if I confused you.
 
Last edited by a moderator:

Wes Bucey

Prophet of Profit
wrodnigg said:
user requirements.............performance qualification
..._____\_______..........___/___________
...functional specs........operational qualification
......_____\___...........___/___________
......design specs........installation qualification
.................\___...____/
..................system build
(ignore the dots, they are used as whitespaces)
:topic: Just for future reference, I hacked the "place holder dots" out of view by changing the text color to white. I got the idea from wrodnigg's comment about "whitespaces."
 
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