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Definition Verification vs. Validation in 7.1.4 - Definition of Verification and Validation

P

PeterL

#1
#1
ISO/TS 16949 says in 7.1.4 "The effects of any change . . .shall be assessed, and verification and validation activities shall be defined.... " and "Changes shall be validated before implementation". What do verification and validation mean here?

Let's say there is an equipment change. How would you, in this case, illustrate verification and validation (and implementation).

Thanks!

Peter
 
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QMS for Medical Device Companies
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B

Bill Ryan - 2007

#2
#2
I'll give it a shot.

Verification: Part characteristics have not been negatively impacted (dimensional).

Validation: Part functional requirements have not been negatively impacted.

Implemented: Can't be implemented until the first two have been satisfied (i.e.: PPAP approved).

:confused: :rolleyes: :confused:

Bill
 
Chennaiite

Chennaiite

Never-say-die
Trusted Information Resource
#3
#3
I Would like to re-start this thread.
Can somebody help me out with more clarification on Verification and Validation?
I remember these V's are used in more than one context like
- For a design or a design change
- For a Containment action
- For a Root cause

Do all these boil down to the same concept?
Thanks.
 
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