Exclusion of 7.3 for infrastructure consulting company

[tussielago]

Hi, first time posting on here, after having tried to find an answer to my question reading through old posts, to no avail.

I am setting up a QMA for a conculting business who deal with infrastructure, so the product developed is drawings, reports and calculations.
I am trying to find out whether 7.3 can be excluded or not, as I am struggling to come up with how to fullfill demands of 7.3.5 and 7.3.6 Verification and Validation.

All I can think of is the following:
Verification - The requirements for the product are listed in the contract - what it is they expect the company to provide. But there is no formal routine to go through a comparison between the contract and the final result. It's too obvious as everyone knows what is to be done and it's spoken about during client meetings continously.

Validation -
In the end of it all the documents are delivered to the customer and they go through them and say if the are happy with it or not, and if any changes needs to be made.

How shall I think around this?
Thankful for all your thoughts!

 

[somashekar]

Hi, first time posting on here, after having tried to find an answer to my question reading through old posts, to no avail.

I am setting up a QMA for a conculting business who deal with infrastructure, so the product developed is drawings, reports and calculations.
I am trying to find out whether 7.3 can be excluded or not, as I am struggling to come up with how to fullfill demands of 7.3.5 and 7.3.6 Verification and Validation.

All I can think of is the following:
Verification - The requirements for the product are listed in the contract - what it is they expect the company to provide. But there is no formal routine to go through a comparison between the contract and the final result. It's too obvious as everyone knows what is to be done and it's spoken about during client meetings continously.

Validation -
In the end of it all the documents are delivered to the customer and they go through them and say if the are happy with it or not, and if any changes needs to be made.

How shall I think around this?
Thankful for all your thoughts!

Welcome to the COVE tussielago
Your are in a business that is primarily design and development.
So forget about 7.3 exclusion.
You may have many other clauses that can be perhaps excluded.
Verification is a desk top work. When you check your deliverable against ensuring that they meet the input requirements, you are verifying.
Validation is not about customer is happy with it or not. Wait to see if your design is built and successful as conceived. This can take time after your delivery. You may also be involved in design and development changes after delivery.
When you read the standard, it says....
"Where practicable, validation shall be completed prior to the delivery or implementation of the product"
In your case it may not be practicable. So you are good to wait and validate.

 

[tussielago]

Thank you for your reply Someshekar.
So I interpret that as that our checks we do before delivery of product, which are carried out by an independent person, are sufficient as verification. They are strictly controlled and records kept.

However, validation is trickier - how can we check whether a sewage pipe is built accordingly? Is it whether the service is provided ok to the people in the area?
And when it is not design, but calculations, such as inspection of a bridge, how many years do the company wait to see if they were correct in their calculations?
This all seems too far fetched to me.

As you say, the standard states "Where practicable, validation shall be completed prior to the delivery or implementation of the product", but our product is the documents, not the actual infrastructure. So why would we need to validate the work of the constructors? Who knows if the problems that may arise with time is theirs and not due to faulty drawings?
Do you understand my concerns?

Many thanks again for your input!

 

[somashekar]

You seem to be stretching it too far.
What is your product / service realization.
Is it providing of documented useable information to your customer concerning Infrastructure.
What the project leader and the team periodically verify, can very well be the verification. If your plan is to get the outputs finally checked by an Independent person (Subject expert), then this phase can be in your design plan as validation.
On the other side, if you can get information that your information provided to customer was successfully executed by your customer or his contractor, this also becomes the validation per your design plan.
You could even consider comparing your final documentation to the applicable Building Code as a part of your validation.
Set it up in your design plan suitably.

 

[Straliatto]

I think you can exclude the whole clause 7.3 since they produce drawings and calculations and they don't develop new methods for drawing and calculating.



Your problem are clasue 7.5.2 Validation of processes for production and service provision, but it can be solved easially. Validation in this case would be the check up to determine whether the drawings and calculations are correct, there is certainly some method to do this check up or maybe it is already implemented.



Regards