Definition Verification vs. Validation - What are the differences?

J

joshua_sx1

#21
Our company just recently aquired a manufacturing division. This required me to remov our 7.3 exclusion(much to my dismay). I created a controlled form that requires all of the measurements to be checked and recorded after the product has been made. Can this be my validation? If so, how do I show verification?

Thanks in advance!
Susan
…well, first of all congratz to your company because it means that you are expanding for adding processes… :agree1:

…anyway just for clarification only, :rolleyes: when you mentioned that you acquired a manufacturing division, that includes adding design & development process?...
 
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#22
To sum it up, design verification are all tests, inspections and analysis intended to verify that the design has the capability of performing its intended function.

Validation is to verify that this capability is maintained over the entire range of inputs, stresses, environmental conditions, regulatory and safety requirements and over production variability (tolerances)
Hello

I still think there´s something misinterpretations...intended function is related to validation, not verification...just see the definition in the beginning of this thread. So any "tests, inspections and analysis intended to verify that the design has the capability of performing its intended function" would be a validation process..."also, verify that this capability is maintained over the entire range of inputs, stresses, environmental conditions, regulatory and safety requirements and over production variability (tolerances)" would also mean validation.

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.
 
J

Jeff Frost

#23
Always use you References..

ISO 9000:2005 defines the answer to your question as.......

3.8.4
verification
confirmation, through the provision of objective evidence (3.8.1), that specified requirements (3.1.2) have been fulfilled

NOTE 1 The term “verified” is used to designate the corresponding status.

NOTE 2 Confirmation can comprise activities such as
— performing alternative calculations,
— comparing a new design specification (3.7.3) with a similar proven design specification,
— undertaking tests (3.8.3) and demonstrations, and
— reviewing documents prior to issue.


3.8.5
validation
confirmation, through the provision of objective evidence (3.8.1), that the requirements (3.1.2) for a specific intended use or application have been fulfilled

NOTE 1 The term “validated” is used to designate the corresponding status.

NOTE 2 The use conditions for validation can be real or simulated.

3.8.1
objective evidence
data supporting the existence or verity of something

NOTE Objective evidence may be obtained through observation, measurement, test (3.8.3), or other means.


Here's how I like to put it.............

Verification checks whether the design meets the original specifications (design input).

Validation checks whether the new product works (does it do what it's supposed to as it is supposed to do it).

Both are important, but different ways of looking at a new product.

The input to for example would be NASCAR regs, but also would include and the owner/engineer/driver input. One of those inputs might have to do with the speed the vehicle needs to be capable of. That speed requirement is translated into an engine design in terms of displacement, horse power, torque, etc.

When the engine is designed and built we 'verify' that it is the displacement specified, supplies the specified torque, produces x amount of horsepower. This is design verification.

We then take it to the track to determine if it can meet the speed requirement, which is the 'end user' requirement. Does it perform? This is design validation. Now, in theory, we should do the validation under use conditions, which would imply running it in a race. In fact, the validation probably is performed in a more 'sterile' condition with just that vehicle on the track.


In retrospect, every flight of every Space Shuttle has been a "Validation" flight to test the new design under actual conditions. No 2 shuttles have ever flown in the same configuration and many systems cannot be validated except under actual conditions.
Randy got it right the first time by quoting the requirements of the standard yet everyone is still trying to define this question. If these are the internationally acceptable definitions of the two terms per ISO 9000 and mandated by ISO 9001 then there is no redefining the definitions to meet personnel preferences.

If an industry, through contract requirements, or as required by law (regulatory/statutory) modify the ISO definition then that is fine. We as implementers or auditors must remember that if we are to comply with the requirements of the international standards we must also use the agreed to language.
 

Marcelo

Inactive Registered Visitor
#24
Randy got it right the first time by quoting the requirements of the standard yet everyone is still trying to define this question. If these are the internationally acceptable definitions of the two terms per ISO 9000 and mandated by ISO 9001 then there is no redefining the definitions to meet personnel preferences.
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.

 

Helmut Jilling

Auditor / Consultant
#25
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.
 
J

Jeff Frost

#26
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
 
W

w_grunfeld

#28
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.
 
V

vanputten

#29
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, ...............
 
W

w_grunfeld

#30
"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.
 
Thread starter Similar threads Forum Replies Date
D Medical Device Design Verification and Validation Differences 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
T Definition Verification and Validation Definitions and Differences Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
Q Differences between Sample Sixes for Design Verification vs. Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 2
I The differences between D&D Review, D&D Verification and D&D Validation? Design and Development of Products and Processes 8
Y SaMD Verification and Validation SOP and Plan IEC 62304 - Medical Device Software Life Cycle Processes 2
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 4
T Laboratory Verification after validation ISO 17025 related Discussions 3
P Design verification driven by new equipment. How is this different than process validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
G Devices from IQ, OQ or PQ process to be used for verification, validation and summative? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Bev D Verification and Validation of Measurement Systems Misc. Quality Assurance and Business Systems Related Topics 0
A Our auditor told if we didn't have a patent we would have to do a validation or verification ISO 13485:2016 - Medical Device Quality Management Systems 6
N Design Verification & Process Validation - Statistical sample sizes Design and Development of Products and Processes 2
D 510K and Changes to Verification and Validation US Food and Drug Administration (FDA) 2
Ed Panek Label verification and validation US Food and Drug Administration (FDA) 5
V Which batches should or could be considered for design validation and design verification? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
I Medical device Validation/Verification template ISO 13485:2016 - Medical Device Quality Management Systems 1
M Does anyone has a good verification and validation plan template? ISO 13485:2016 - Medical Device Quality Management Systems 3
S Source of QMS templates including templates for design verification/design validation Document Control Systems, Procedures, Forms and Templates 2
Ed Panek Verification & Validation requirements - Patch that adheres to skin ISO 13485:2016 - Medical Device Quality Management Systems 2
M Bringing blending in-house - Verification or full validation? (Disinfectants) ISO 13485:2016 - Medical Device Quality Management Systems 3
A Level of details required for Class IIb Product Verification and Validation CE Marking (Conformité Européene) / CB Scheme 1
S CE Mark Approval Design Verification and Validation Questions CE Marking (Conformité Européene) / CB Scheme 8
S What is the difference between Verification and Validation of Test Reports? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M IEC 62366-1:2015 Usability Verification / Validation Plan example wanted IEC 62366 - Medical Device Usability Engineering 20
shimonv System Verification & Validation in HC Class III Submission Canada Medical Device Regulations 2
G Verification or Validation for Glue Dispenser Units ? Qualification and Validation (including 21 CFR Part 11) 4
T Validation and Verification - Catheter into a tyvek pouch ISO 13485:2016 - Medical Device Quality Management Systems 2
D User Requirements Tracing - Verification and Validation Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Validation before Verification. Why not? ISO 13485:2016 - Medical Device Quality Management Systems 3
H Is design verification and validation required for samples accompanying the quotes ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
E How to write requirements for Medical App Validation and Verification IEC 62366 - Medical Device Usability Engineering 7
Chennaiite Cause Analysis for Verification/Validation Failures - Seeking Opinions Problem Solving, Root Cause Fault and Failure Analysis 3
F Usability Objectives and Verification & Validation Plan IEC 62366 - Medical Device Usability Engineering 6
S Verification and Validation of Post Market Design Change Design and Development of Products and Processes 2
M Validation/Verification Trace matrix - examples or recipe? Document Control Systems, Procedures, Forms and Templates 1
T Class II Software Device 510k V&V (Verification and Validation) Criteria and Results 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
V Utility (power production) Company - Mitigating risks in Verification and Validation. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A Should the FSMS have a Documented Generic Procedure for Verification and Validation Food Safety - ISO 22000, HACCP (21 CFR 120) 2
P What is Validation, Verification and Improvement of FSMS in ISO 22000 Clause 8? Food Safety - ISO 22000, HACCP (21 CFR 120) 2
P How to separate Product Design Review, Verification, and Validation Activities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
T Medical Device Software Verification & Validation for Client Specific Configurations Design and Development of Products and Processes 2
Q Verification & Validation Project Time Line Qualification and Validation (including 21 CFR Part 11) 5
M Design and Development Outputs Approval, Verification and Validation IATF 16949 - Automotive Quality Systems Standard 4
G Legacy Product - Do we need follow QSR 820? Design Verification and Validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
S Design and Development - Review vs. Verification vs. Validation Design and Development of Products and Processes 15
G Sample Size for Design Verification and Validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
A Does the V&V (Verification and Validation) belong to Bench Testing for 510k? Qualification and Validation (including 21 CFR Part 11) 2
K Verification, Validation or Checking? Definition of the word "Checked" Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
B Is Ship Test considered Design Verification or Design Validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Design Input/Output and Design V&V (Verification and Validation) Interpretations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 14

Similar threads

Top Bottom