ISO 9001 Design & Development - 7.3.4 Review, 7.3.5 Verify, 7.3.6 Validate

Y

YKT

7.3.4 - Design & Developmentr REview
7.3.5 Design & Development Verification
7.3.6 Design & Development Validation

Can someone please differentiate the terms - review / verify and validate in layman term ?
 
S

sal881vw

Design and development review is,
to evaluate the ability of the results of design and development to fulfill requirements,
to identify any problems and propose necessary actions.

Design and development verification is.
to ensure that the design and development outputs have satisfied the design and development input requirements,


Design and development validation,
to ensure that the resulting product is capable of fulfilling the requirements for the specified or known intended use or application.
 
Y

YKT

thanks.

what are the actions that distinguish a review and a verification ? for instance, what do a company do to satisfy 'review' and 'verification' ?
 

Marc

Fully vaccinated are you?
Leader
A design review is an overall review which typically recurrs.

Verification is typically thought of as being done at an early phase and is a review of calculations and other 'paper' exercises.
 
B

BadgerMan

YKT said:
what are the actions that distinguish a review and a verification ? for instance, what do a company do to satisfy 'review' and 'verification' ?

Design Reviews are formal (usually meetings) and cross-functional in nature and conducted at critical points during the design and development process (as defined by plan/schedule). Generally speaking, reviews are scheduled at strategic points in the process and involve things like transition criteria and progression to the next stage of the design process.

Design Verification is performed to verify that design outputs satisfy the input requirements. Verification is more iterative, focused, and continuous in nature and can take several forms in addition to the obvious one, that being testing.
 
C

ccochran

YKT,

You've already gotten some excellent replies, but here's mine anyway:

Design and Development Review

Design review is something we do periodically during the design process to make sure we’re on track. Is everything going as planned? Have any problems come up? Do we need to do something differently? The whole point of design review is to identify and remove roadblocks to successful design.
During design planning, we identified the various stages of the design. As part of this, we should have also determined the number and timing of the design reviews. Every design will have at least one design review, and complex or troublesome designs may require many more.
People involved in design reviews must include the representatives from functions involved in that stage of the design. So, excluding a key player for the sake of convenience would be a problem. When conducting design reviews, make sure you’re including the appropriate people.
Finally, design reviews always produce records. The record will indicate the results of the reviews and any necessary actions the design team decided to take. Design reviews could take the form of meeting minutes, memos, design files, emails, or other records.

Design and Development Verification

Verification is where we compare the outputs against the inputs. Does the available evidence indicate that the design will meet our requirements? The verification could consist of calculations, simulations, prototype evaluation, lab tests, comparison against samples, first article inspection, or other methods. You must maintain records of design verification, and these will indicate the results of verifications and any actions necessary.

Design and Development Validation

Validation is similar to verification, except this time we’re actually checking the designed product under conditions of actual use. So, if we’re designing dune buggies, we might take our creation for a spin on the beach. If we’re making beverages, we might conduct consumer taste tests. Verification is theoretical, but validation is the real world.
We’re required to conduct validation prior to delivery or implementation, if possible. Records of validation must be maintained.


Good luck,
CC

~~~~~~~~~~~~~~~~~~~~~~~~~~~
Craig Cochran
Center for International Standards & Quality
Georgia Institute of Technology
[email protected]
 
D

David Hartman

Just to add a little to the excellent responses you've received. Design Reviews may in-fact include discussions regarding the results of Design Verifications. Design Verifications can, and should (where appropriate), occur at several points in the design development cycle such as: Module design completion, Sub-system design completion, and System design completion.

Validation may also occur at these same points, but at a minimum must occur at the System level (BTW: Results of Validation may also be a point of discussion in the Design Reviews).

Verification - is a specific action to verify design output (specifications and documentation) against design input (customer requirements).

Validation - is a specific action to validate the final product (or module/sub-system) against customer requirements in real-world, end-use environments.

Design Review - is a forum for discussing design alternatives, design progress, budget, road-blocks, issues, verification results, validation results, etc.
;)
 
T

TSRao

Hi,

Can Some one help me in getting the forms for following:

7.3.4 - Design and development review
7.3.5 - Design and development verification
7.3.6 - Design and development validation:agree:
 

Stijloor

Leader
Super Moderator
Hi,

Can Some one help me in getting the forms for following:

7.3.4 - Design and development review
7.3.5 - Design and development verification
7.3.6 - Design and development validation:agree:

Hello TS,

You don't need specific designed "forms" for these activities. Just record the results in a format that makes sense to those involved. Could be hard copy, computer generated, etc. These records could be integrated with a design and development project management software program; whatever works for you.

Hope this helps.

Stijloor.
 
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