The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page

Go Back   The Elsmar Cove Forum > Information Resources - Papers - Articles - Etc. > Definitions, Acronyms, Abbreviations and Interpretations
Forum Username

Elsmar Cove Forum Visitor Notice(s)


Elsmar Cove Forum Sidebar
Custom Search
Monitor the Elsmar Forum
Monitor New Forum Posts
Follow Marc & Elsmar
Elsmar Cove Forum RSS Feed  Marc Smith's Google+ Page  Marc Smith's Linked In Page   Marc Smith's Elsmar Cove YouTube Page  Marc Smith's Facebook Page
Elsmar Cove Groups
Elsmar Cove Google+ Group  Elsmar Cove LinkedIn Group  Elsmar Cove Facebook Group
Sponsor Links







Donate and $ Contributor Forum Access
Sponsored Links
Courtesy Quick Links

Links that Elsmar Cove visitors will find useful in your quest for knowledge:


Howard's
International Quality Services

Atul's
Symphony Technologies

Marcelo Antunes'
SQR Consulting

Bob Doering's
Correct SPC - Precision Machining


NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest Portal

IEST - Institute of Environmental Sciences and Technology

ASQ - American Society for Quality


Related Topic Tags
verification (general), validation of machines equipment processes design etc., differences (general)
Reply
 
Thread Tools Search this Thread Rating: Thread Rating: 4 votes, 5.00 average. Display Modes
  #25  
Old 4th June 2008, 11:09 AM
Helmut Jilling Helmut Jilling is offline
Auditor / Consultant

 
Registration Date: Aug 2005
Location: Charlotte, NC and Akron, OH
Age: 58
 
Posts: 4,030
Thanks Given to Others: 488
Thanked 1,021 Times in 696 Posts
Karma Power: 451
Karma: 8117
Helmut Jilling is appreciated, and has over 1700 Karma points.Helmut Jilling is appreciated, and has over 1700 Karma points.
Helmut Jilling is appreciated, and has over 1700 Karma points.Helmut Jilling is appreciated, and has over 1700 Karma points.Helmut Jilling is appreciated, and has over 1700 Karma points.Helmut Jilling is appreciated, and has over 1700 Karma points.Helmut Jilling is appreciated, and has over 1700 Karma points.Helmut Jilling is appreciated, and has over 1700 Karma points.Helmut Jilling is appreciated, and has over 1700 Karma points.Helmut Jilling is appreciated, and has over 1700 Karma points.Helmut Jilling is appreciated, and has over 1700 Karma points.Helmut Jilling is appreciated, and has over 1700 Karma points.Helmut Jilling is appreciated, and has over 1700 Karma points.Helmut Jilling is appreciated, and has over 1700 Karma points.Helmut Jilling is appreciated, and has over 1700 Karma points.
Re: Verification vs. Validation - What are the differences?

Quote:
In Reply to Parent Post by mmantunes View Post

I think the main problem is that the definition of the standard is generic, and don´t show how it fits in the process.

For example, from the definitions it´s difficult to understand things as shown in the waterfall model below.

What about the diagram is hard to understand? Design verification tends to be on paper or electronic, verifying that all the inputs were addressed and expected to be achived.

Validation is generally performed on an actual part or prototype part to determine whether this sucker will meet the customer or user needs. I think it does a great job of showing the links.
__________________
Relentlessly Pursue Excellence!
Thanks to Helmut Jilling for your informative Post and/or Attachment!

Sponsored Links
  #26  
Old 4th June 2008, 11:10 AM
Jeff Frost Jeff Frost is offline
$ Contributor

 
Registration Date: May 2004
Location: Orange County, California
 
Posts: 621
Thanks Given to Others: 108
Thanked 244 Times in 172 Posts
Karma Power: 102
Karma: 1762
Jeff Frost is appreciated, and has over 1700 Karma points.Jeff Frost is appreciated, and has over 1700 Karma points.Jeff Frost is appreciated, and has over 1700 Karma points.Jeff Frost is appreciated, and has over 1700 Karma points.Jeff Frost is appreciated, and has over 1700 Karma points.Jeff Frost is appreciated, and has over 1700 Karma points.Jeff Frost is appreciated, and has over 1700 Karma points.Jeff Frost is appreciated, and has over 1700 Karma points.Jeff Frost is appreciated, and has over 1700 Karma points.Jeff Frost is appreciated, and has over 1700 Karma points.Jeff Frost is appreciated, and has over 1700 Karma points.
Re: Verification vs. Validation - What are the differences?

mmantunes

Yes they are but they are also used in conjunction with the requirements contained within the Standard Your waterfall model is only showing pictorially what is required by clause 7.3
Sponsored Links

  #27  
Old 4th June 2008, 04:03 PM
Marcelo Antunes's Avatar
Marcelo Antunes Marcelo Antunes is offline
Addicted to standards

 
Registration Date: Mar 2006
Location: São Paulo, SP, Brazil
 
Posts: 2,018
Thanks Given to Others: 289
Thanked 1,501 Times in 806 Posts
Karma Power: 253
Karma: 11094
Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.
Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.
Send a message via ICQ to Marcelo Antunes Send a message via MSN to Marcelo Antunes Send a message via Skype™ to Marcelo Antunes
Re: Verification vs. Validation - What are the differences?

Quote:
Your waterfall model is only showing pictorially what is required by clause 7.3
Which is the original questioning of this thread.
__________________
I'm a moderator on the medical device forums, so if you need help with something, feel free to ask!
  #28  
Old 5th June 2008, 10:00 AM
w_grunfeld w_grunfeld is offline
Willy Grunfeld

 
Registration Date: Jul 2005
Location: Israel
 
Posts: 215
Thanks Given to Others: 18
Thanked 65 Times in 51 Posts
Karma Power: 55
Karma: 868
w_grunfeld is appreciated, and has over 700 Karma points.w_grunfeld is appreciated, and has over 700 Karma points.w_grunfeld is appreciated, and has over 700 Karma points.w_grunfeld is appreciated, and has over 700 Karma points.w_grunfeld is appreciated, and has over 700 Karma points.w_grunfeld is appreciated, and has over 700 Karma points.w_grunfeld is appreciated, and has over 700 Karma points.
Re: Verification vs. Validation - What are the differences?

Quote:
In Reply to Parent Post by mmantunes View Post

Hello

Verification would verify that the input requirements are met.....this not not mean that necessarily the intended function is met, because the input requirements in the design phase could be wrong translated from the costumer requirements.
Well if your design input requirements do not include the intended function, you've got a big problem pal, regardless how we play with words...
If a glucose meter does not measure glucose level in the blood , I would not bother doing any other activities whether you call them verification or validation, just scrap the project and start all over.
Gentlemen, in the real word, not all is definitions and auditor's opinions.
ISO is too generic to debate the meaning of this or that word.
What counts is how we interpret ISO to adapt it to real life. I hope all agree at least that validation is to be done on a production sample , meaning a product that was manufactured to the same documentation, processes and machinery used /to be used for the actual production run.
If we agree as much, than simply any paper review, inspection, measuement or test that is performed on anything other than a production product is verification.

No one in his right mind would release a design to production prior to thoroughly verifying the design. (Even if the ISO auditor says that according with section so and so , that's validation) Who ever says that design inputs can be verified on paper or electronically only , hasn't faced a technologically complex product.
For any product that is somewhat complex (more than a fiew simple parts ) design verification is actually done in several phases and steps. No one would spend tons of money to even prepare for production (tooling alone could cost a bundle) without verifying every aspect of the design.
As for design inputs/intended function here is a joke that is actually based on fact:
I worked once upon a time on a fighter aircraft project.
The spec was somewhat like 700-800 pages and it referred to a few dozens other documents, totalling thousands of pages.
One day at a meeting , someone threw a remark: "Have you noticed that nowhere in all these thousands of pages does it say that this thing has to fly !"
And he was right.
__________________
Willy Grunfeld
RAMSQ Consultant
Thank You to w_grunfeld for your informative Post and/or Attachment!
  #29  
Old 5th June 2008, 12:16 PM
vanputten's Avatar
vanputten vanputten is offline
Dirk

 
Registration Date: Jun 2004
Location: California, USA
 
Posts: 1,068
Thanks Given to Others: 410
Thanked 280 Times in 201 Posts
Karma Power: 153
Karma: 5247
vanputten is appreciated, and has over 1700 Karma points.
vanputten is appreciated, and has over 1700 Karma points.vanputten is appreciated, and has over 1700 Karma points.vanputten is appreciated, and has over 1700 Karma points.vanputten is appreciated, and has over 1700 Karma points.vanputten is appreciated, and has over 1700 Karma points.vanputten is appreciated, and has over 1700 Karma points.vanputten is appreciated, and has over 1700 Karma points.vanputten is appreciated, and has over 1700 Karma points.vanputten is appreciated, and has over 1700 Karma points.vanputten is appreciated, and has over 1700 Karma points.vanputten is appreciated, and has over 1700 Karma points.vanputten is appreciated, and has over 1700 Karma points.vanputten is appreciated, and has over 1700 Karma points.
Re: Verification vs. Validation - What are the differences?

I don't understand what this debate is all about and I don't understand W_Grunfeld's arguement towards the other postings. Verification and validation are different things and both important.

Verifiy the design requirements are met, whatever they are. Does it have a wing? An engine? Does the thing have everything as detailed in the 700 pages?

Validate that the thing meets its intended purpose. Does it fly as the customer would expect?

Do verification and validation how your organization best beleives it is effective. In unique independent events, in stages, concurrently, ...............
Thanks to vanputten for your informative Post and/or Attachment!
  #30  
Old 6th June 2008, 12:47 PM
w_grunfeld w_grunfeld is offline
Willy Grunfeld

 
Registration Date: Jul 2005
Location: Israel
 
Posts: 215
Thanks Given to Others: 18
Thanked 65 Times in 51 Posts
Karma Power: 55
Karma: 868
w_grunfeld is appreciated, and has over 700 Karma points.w_grunfeld is appreciated, and has over 700 Karma points.w_grunfeld is appreciated, and has over 700 Karma points.w_grunfeld is appreciated, and has over 700 Karma points.w_grunfeld is appreciated, and has over 700 Karma points.w_grunfeld is appreciated, and has over 700 Karma points.w_grunfeld is appreciated, and has over 700 Karma points.
Re: Verification vs. Validation - What are the differences?

"Verification and validation are different things and both important."
No one said otherwise ......
Read the beginning of the thread : the question was what is considered verification and what is validation. When people started to give specific
examples, most were mixing up between the two.

To the best of my knowledge I did not post anything "against" other posters. I did argue some of others opinions, isn't this forum excatly for that?
The 700 pages airfraft spec was a joke- there is really no need to comment on jokes.
__________________
Willy Grunfeld
RAMSQ Consultant
  #31  
Old 6th June 2008, 01:11 PM
Randy's Avatar
Randy Randy is offline
Super Moderator

 
Registration Date: Jun 1999
Location: Greenwood (Ft Smith area), Arkansas, USA
Age: 61
 
Posts: 8,034
Thanks Given to Others: 48
Thanked 2,533 Times in 1,568 Posts
Karma Power: 897
Karma: 18993
Randy is appreciated, and has over 1700 Karma points.Randy is appreciated, and has over 1700 Karma points.
Randy is appreciated, and has over 1700 Karma points.Randy is appreciated, and has over 1700 Karma points.Randy is appreciated, and has over 1700 Karma points.Randy is appreciated, and has over 1700 Karma points.Randy is appreciated, and has over 1700 Karma points.Randy is appreciated, and has over 1700 Karma points.Randy is appreciated, and has over 1700 Karma points.Randy is appreciated, and has over 1700 Karma points.
Send a message via Skype™ to Randy
Re: Verification vs. Validation - What are the differences?

Quote:
In Reply to Parent Post by w_grunfeld View Post

Quote:
To the best of my knowledge I did not post anything "against" other posters. I did argue some of others opinions, isn't this forum excatly for that?
To a certain degree it is, we just need to ba careful how passionate that agument is.

Quote:
The 700 pages airfraft spec was a joke- there is really no need to comment on jokes.
You'll find that some folks have no sense of humor, so one has to be careful. (Most of them don't go to the bathroom either)

You provided pretty good comment, just hang in there and stay involved.
__________________
We who have seen war, will never stop seeing it. In the silence of the night, we will always hear the screams. Joe Galloway
  #32  
Old 6th June 2008, 03:53 PM
Kevin Mader's Avatar
Kevin Mader Kevin Mader is offline
One of THE Original Covers!

 
Registration Date: Nov 1998
Location: Wallingford, CT USA
Age: 46
 
Posts: 1,215
Thanks Given to Others: 33
Thanked 122 Times in 80 Posts
Karma Power: 400
Karma: 1630
Kevin Mader is appreciated, and has over 1500 Karma points.Kevin Mader is appreciated, and has over 1500 Karma points.Kevin Mader is appreciated, and has over 1500 Karma points.Kevin Mader is appreciated, and has over 1500 Karma points.Kevin Mader is appreciated, and has over 1500 Karma points.Kevin Mader is appreciated, and has over 1500 Karma points.Kevin Mader is appreciated, and has over 1500 Karma points.Kevin Mader is appreciated, and has over 1500 Karma points.Kevin Mader is appreciated, and has over 1500 Karma points.Kevin Mader is appreciated, and has over 1500 Karma points.Kevin Mader is appreciated, and has over 1500 Karma points.
Send a message via AIM to Kevin Mader
Re: Verification vs. Validation - What are the differences?

More for the mix…

Customer need: chocolate cake

How will this be specified? Milk chocolate, dark or perhaps a blend? If I gather the ingredients, develop a recipe, mix the ingredients and bake the cake, will the customer be happy?

Through verification activities, I can confirm that my inputs are correct, the proportions correctly measured, and blending and bake times correct. There’s still no guarantee that the customer will like my chocolate cake, but I did create a chocolate cake.

Through validation, I need to confirm that I’ve met the consumer’s expectations (requirements). Did I use enough chocolate or too much? Was the cake moist and fluffy? All the bench testing (verification) in the world can’t confirm that I’ve met expectations. I must have the consumer’s (user’s) confirmation. It's the one that counts!!

Marketing specifications, which are usually vague, establish the general customer requirements. These must be refined into more detailed requirements (which can take the shape of product requirements) for engineering. Here, the engineering team establishes design requirements on how they plan to fulfill the customer needs. These might be thought of as to how the engineering team plans to mechanically and electronically establish the product the customer wants. These initial design requirements will undergo an iterative design process until final input requirements can be established. Often times, engineering test is performed during this development phase (sniff testing), but this is not yet design verification. Customer preference testing might also be done at this time to further dial in the product requirements. Design verification will occur later after the final design inputs have been established, generally in the form of a design requirements specification. Design Verification activities trace directly to the Design Inputs. Design Validation is performed to confirm that the customer/end user requirements (intended uses) have been met. As noted in Randy’s post, both activities are important, but separate.

Potential document/activity hierarchy:

· Marketing Specification (top level user needs sometimes called a User Needs Document)
· Product Specification (engineering translation of user needs)
· Design Requirements (initial design inputs, perhaps broken down into subordinate requirements documents for recognized disciplines such as mechanical, electrical, software, etc.)
· Design Requirements Specifications (final design inputs)
· Design Verification (confirmation of final design inputs)
· Design Validation (confirmation of user needs)

It has been my experience that mastery of these two concepts is difficult. I suspect that this is why there is disagreement amongst us Covers, especially for those folks who seldom engage in validation activities. The thing of it is that through continued discussion and debate, we continue to refine our theory of what verification and validation are. For me, I’m always in a curious mode to refine my own theory, so I enjoy these types of exchanges.

Enough for now, so back to the group…

Kevin
__________________
"Without theory there is nothing to modify or learn." W. Edwards Deming
Thanks to Kevin Mader for your informative Post and/or Attachment!
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Forum > Information Resources - Papers - Articles - Etc. > Definitions, Acronyms, Abbreviations and Interpretations

Do you find this discussion thread helpful and informational?


Bookmarks

Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Medical Device Design Verification and Validation Differences dweebie US Medical Devices (21 CFR part 820) 15 16th August 2012 08:05 AM
Verification and Validation Definitions and Differences tammydiz Definitions, Acronyms, Abbreviations and Interpretations 9 1st March 2011 01:08 PM
Verification vs. Validation in 7.1.4 - Definition of Verification and Validation PeterL Definitions, Acronyms, Abbreviations and Interpretations 2 7th May 2009 01:43 AM
Differences between Sample Sixes for Design Verification vs. Process Validation qekim ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 2 19th March 2007 12:27 PM
The differences between D&D Review, D&D Verification and D&D Validation? issmart Design and Development - Process and Product 8 5th March 2007 05:14 AM



The time now is 03:36 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


   


Marc Timothy Smith - Elsmar.com
8466 LeSourdsville-West Chester Road, Olde West Chester, Ohio 45069-1929
513 341-6272