How to perfom Design Validation for Road Designs

N

North36

#1
Dear All,

I have been a project coordinator for establishing quality management system based on ISO 9001:2008 requirement for the past couple of years. I have faced a challenge when I was working in a Road designing company last time regarding design validation requirement. This requirement is again mentioned in the revised standard- ISO 9001:2015.
Can anyone share me how a road design can be validated? If we follow the same process used in validating product designs we need at least more than a year. This is because Roads can not be built in prototype and then validate in different scenarios. Please I need your practical inputs here.

Regards
 
Elsmar Forum Sponsor

Randy

Super Moderator
#2
Re: How to perfom Validation for Road Designs

After it has been built does the road go from point A to point B as designed?
 

Pancho

wikineer
Super Moderator
#3
Re: How to perfom Validation for Road Designs

Dear All,

I have been a project coordinator for establishing quality management system based on ISO 9001:2008 requirement for the past couple of years. I have faced a challenge when I was working in a Road designing company last time regarding design validation requirement. This requirement is again mentioned in the revised standard- ISO 9001:2015.
Can anyone share me how a road design can be validated? If we follow the same process used in validating product designs we need at least more than a year. This is because Roads can not be built in prototype and then validate in different scenarios. Please I need your practical inputs here.

Regards
Hello North,

Validation can be easily be done on the first, say, 100ft of road that you complete. You can inspect, measure and test any relevant characteristics on such to your contract's and control plan's requirements. Any NCs can be corrected immediately, and action taken so that your whole road will be compliant.

We manufacture large structures and we have a similar procedure. Waiting until the structure is finished to validate it defeats the purpose of validation. Instead, we assemble the first two-to-four tons of structure produced into a "test module" that our engineers then validate. The results are recorded onto a form and it becomes the validation record. These initial tons of structure are not wasted. After validation, they are knocked down, packaged and delivered with the rest of the structure.

I hope this helps!
 

Ronen E

Problem Solver
Moderator
#4
Re: How to perfom Validation for Road Designs

Hello North,

Validation can be easily be done on the first, say, 100ft of road that you complete. You can inspect, measure and test any relevant characteristics on such to your contract's and control plan's requirements. Any NCs can be corrected immediately, and action taken so that your whole road will be compliant.

We manufacture large structures and we have a similar procedure. Waiting until the structure is finished to validate it defeats the purpose of validation. Instead, we assemble the first two-to-four tons of structure produced into a "test module" that our engineers then validate. The results are recorded onto a form and it becomes the validation record. These initial tons of structure are not wasted. After validation, they are knocked down, packaged and delivered with the rest of the structure.

I hope this helps!
As far as I understand what you describe would be a verification rather than a validation. Validation is about whether or not user needs (stated or otherwise) have been met, while verification is about compliance with stated specifications. Randy's response points in the right direction. Of course, there are road user needs that go a bit beyond going from pont A to point B (not to mention the needs of other stakeholders).

Honestly, I can't imagine a way to validate a road (let alone a road design), in the true sense of the term, without constructing that road first. I'm not from that industry but I'll take a wild guess that wherever there's a strict requirement to validate a road (or its design) it lapses down to a convention that says something along the lines of "we know from experience that if technical specifications A, B and C are met, stakeholders' needs will be satisfied as well, to a high probability". Then it comes down to verifying A, B and C. Again, just a wild guess. Would be interesting to hear someone form that industry.

Cheers,
Ronen.
 
#5
Re: How to perfom Validation for Road Designs

Are you also responsible for the road laying, or perhaps the BOOT (Build Own Operate Transfer) ... Validation can happen post realization (as applicable)
If you are only design responsible, you are going to validate it by monitoring the realization to your design and build data post use.

(In the case of road, it may not be practicable to complete validation prior to delivery or implementation. The 7.3.6 of the 2008 version is clear about this. The note at 8.3.4 of the 2015 version is not too clear about this)

Your Risk based thinking and your organizational knowledge are handy at validation stage post realization.
 
Last edited:

harry

Trusted Information Resource
#6
This is interesting because road designs are just some calculations and drawings on paper (intangible).

In the system that follows the British practices and which I am familiar with, final validation is deemed completed when the overall design was checked and certified by the professional engineer who then affixed his professional stamp. From then, he is legally responsible for the integrity of the design.

In some countries, another professional engineer (a checker) needs to check the design and certify that it meets requirements. This can be considered validation too.

For very complex design, experts in particular areas may be engaged to certified that the design for the particular area meet requirements and in cases where new concepts or approaches to the design are employed, scale models may be used to validate the design.
 

Ronen E

Problem Solver
Moderator
#7
This is interesting because road designs are just some calculations and drawings on paper (intangible).

In the system that follows the British practices and which I am familiar with, final validation is deemed completed when the overall design was checked and certified by the professional engineer who then affixed his professional stamp. From then, he is legally responsible for the integrity of the design.

In some countries, another professional engineer (a checker) needs to check the design and certify that it meets requirements. This can be considered validation too.

For very complex design, experts in particular areas may be engaged to certified that the design for the particular area meet requirements and in cases where new concepts or approaches to the design are employed, scale models may be used to validate the design.
In the medical industry (where I come from) those would be considered forms of verification as well (e.g. calculations check by a peer engineer). I know that the (general) software industry views the terms verification and validation in a somewhat similar way. Regardless, I can easily conceive that other industries have different technical terminology; and of course there's also the legal aspect - giving legal validity to the design (and assigning legal responsibility).

:topic:

As to validating an "intangible" entity (the design) - in the medical industry it's common to refer to a "design validation" even though a more correct terminology would be "product validation" (which is used much less). The term "design validation" is used in contrast with "process validation" which is the validation of the production process (provision of evidence that the process consistently and accurately realises the design as specified).
 

harry

Trusted Information Resource
#9
In the medical industry (where I come from) those would be considered forms of verification as well (e.g. calculations check by a peer engineer). I know that the (general) software industry views the terms verification and validation in a somewhat similar way. Regardless, I can easily conceive that other industries have different technical terminology; and of course there's also the legal aspect - giving legal validity to the design (and assigning legal responsibility). .
There seems to be a fine line between verification and validation but on closer examination, it is actually quite different for civil works design of this nature.

A road work design would typically involved many specialties such as survey, soil engineering, structure, drainage, pavement and m&e. Verification of the design is continuously carried out by each specialty, coordinated by the lead engineer. At the end, a very experience guy needs to look at the work of all these areas of specialty when strung together and certify that when put together, it works. This is validation.
 

Ronen E

Problem Solver
Moderator
#10
There seems to be a fine line between verification and validation but on closer examination, it is actually quite different for civil works design of this nature.

A road work design would typically involved many specialties such as survey, soil engineering, structure, drainage, pavement and m&e. Verification of the design is continuously carried out by each specialty, coordinated by the lead engineer. At the end, a very experience guy needs to look at the work of all these areas of specialty when strung together and certify that when put together, it works. This is validation.
Interesting.

I see it as parallel with multidisciplinary systems development, where we have all the specialist engineers and then the systems engineer or integration specialist. Regardless, in essence, at least in the medical manufacturing industry, verification is about checking outcomes (usually designs or prototypes) against specifications, while validation is about trying to assess whether user needs have been satisfied by the actual final product (BTW, the user/stakeholder many times fails to specify their needs clearly, and sometimes is not even fully aware of). The difference is not about who does it or what techniques are used (sometimes they are quite similar), but in what is actually being checked.

I also understand that it might be very different for other industries, certianly for big one-off projects like civil works.

Good discussion!
 
Last edited:
Thread starter Similar threads Forum Replies Date
armani 7.1.5 and design and development of product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Sidney Vianna ISO 9001 News ISO 9001 Design Specification to be developed - May 2022 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
C Design output vs acceptance criteria ISO 13485:2016 - Medical Device Quality Management Systems 8
M Design Control Procedure Medical Device and FDA Regulations and Standards News 4
lisap Design falling outside ISO scope Misc. Quality Assurance and Business Systems Related Topics 11
S Link Between Essential Performance Requirements and Essential Design Outputs 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
G Calculating Ppk for Design Verification - Variable Sampling Design and Development of Products and Processes 15
G How many Design FMEAs do you have? FMEA and Control Plans 4
G Updating FMEAs after Design Updates FMEA and Control Plans 4
Stoic Details of Operational Qualification (OQ) test design for plastic extrusion processes, effect of material property noise, and GHTF/SG3/N99-10 US Medical Device Regulations 2
H R&D and Design procedures - can one procedure cover both activities Design and Development of Products and Processes 6
J Design Verification Testing and Statistics Reliability Analysis - Predictions, Testing and Standards 3
K Can I make an exclusion of Design and Development in ISO 13485:2016 if my product is not regulated ISO 13485:2016 - Medical Device Quality Management Systems 12
S Audit Finding - Design History File (DHF) Index: few (3 to 4) reports not identified ISO 13485:2016 - Medical Device Quality Management Systems 3
S Is the Design Service Provider required to be ISO 13485 certified? ISO 13485:2016 - Medical Device Quality Management Systems 13
M How to show the effect of the failure mode on the manufacturing process as a customer of product design process? FMEA and Control Plans 3
C MDR - Annex II _3. DESIGN AND MANUFACTURING INFORMATION_a EU Medical Device Regulations 3
C Items used for Design Verification Design and Development of Products and Processes 7
S Software design document NMPA guidance and consultant China Medical Device Regulations 3
L Corrective and Preventive Actions aligned to design related defects. After Work and Weekend Discussion Topics 5
E DESIGN VALIDATION, USABILITY AND CLINICAL EVALUATION request Medical Device and FDA Regulations and Standards News 0
Watchcat REGULATORY WATCHCAT De Novo Post-Mortem 4 – Design Controls Other US Medical Device Regulations 0
D Finding Optimum Design Parameters using Taguchi method? Using Minitab Software 2
S ISO13485:2016 7.3.9 design and development change ISO 13485:2016 - Medical Device Quality Management Systems 3
J Managing design verification regression testing of design changes Design and Development of Products and Processes 1
K Design History File - Looking for Examples of DHF's. 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Watchcat Software validation vs design V&V? Other US Medical Device Regulations 27
S Design & Development records for Medical Devices Packaging and Labelling ISO 13485:2016 - Medical Device Quality Management Systems 9
D Using electronic lab notebooks in the design control process ISO 13485:2016 - Medical Device Quality Management Systems 3
L Essential Design Outputs for SAMD 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T Justification of "Design Excluded" in IATF 16949 Design and Development of Products and Processes 5
H Contract Manufacturer as Design Owner ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
B Drawings - Design Rules Inspection, Prints (Drawings), Testing, Sampling and Related Topics 26
R Role of QA during Design and Development of Products and Processes Design and Development of Products and Processes 4
B Design Responsibilities for Mature Acquired Product Lines ISO 13485:2016 - Medical Device Quality Management Systems 3
I RWE Studies and Design Controls US Food and Drug Administration (FDA) 1
G How to record Regulations and Standards as Design Inputs? Design and Development of Products and Processes 15
T Design Traceability - Labelling / Instructions for Use ISO 13485:2016 - Medical Device Quality Management Systems 5
B How to exclude empty rows in full factorial design analysis? Using Minitab Software 0
M Handling design changes with use-as-is inventory disposition Quality Manager and Management Related Issues 6
M Design Control - Management of Electronic CAD files Design and Development of Products and Processes 14
S Examples of FDA acceptable Software Design Specification (SDS) Medical Device and FDA Regulations and Standards News 6
A Design Change/ECO Related Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R Using R package to implement Bayesian phase I/II dose-finding design for three outcomes ISO 13485:2016 - Medical Device Quality Management Systems 6
C ISO 9001:2015 8.3.2. h) Design and Development Planning - What is required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Z Software for design control ISO 13485:2016 - Medical Device Quality Management Systems 5
E Design and Development file Procedure ISO 13485:2016 - Medical Device Quality Management Systems 0
DuncanGibbons Section 8.3 relevant for design organisations AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
P DFMEA - Machinery Design Best Practices FMEA and Control Plans 0
R Is a FAIR required on parts that we design? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5

Similar threads

Top Bottom