Design and Development Validation at the Customer's Location

[Mario Alberto83]

Good afternoon

I would like to have you input for the following scenario.

We are a small mechanical design company and our procedures have controls for validating design outputs with customer engineering department or designee.

The stuff we design is actually sent to our customer?s customer directly.
I would like to know if there is any problem if we do not validate the design with our customer, but directly with the end customer due to they know exactly what they want.

Based on the note saying that we have to validate design with customer engineering department or designee, I would think in those cases, that designee is the end customer.

As we are about to gather records for the certification process, I would like to know if this situation would become a gap during the certification audit, I do not see any restriction in the standard to proceed per my assumption.

Thank you in advance

 

[Big Jim]

I do not see any restriction in the standard to proceed per my assumption.

Thank you in advance

Neither do I. The one thing I can see to be careful of is to make sure there are no holes in your customer designating their customer to work with you on design validation.

Another option would be to reword your procedure so that no mention of who helps you with validation is made or perhaps to more fully explain potential designees.

 

[Mario Alberto83]

Hello Big Jim

I guess I will take your advice on full explanation for designees as a reference information so it is clearer during tasks performance.

Thank you and regards

 

[somashekar]

I would like to know if there is any problem if we do not validate the design with our customer, but directly with the end customer due to they know exactly what they want.

The requirement is design and development validation.
Where and how and who does it is a matter of a plan. Please put it in the design and development planning, that gets approved and then you are just fine ...

 

[Mikishots]

Good afternoon

I would like to have you input for the following scenario.

We are a small mechanical design company and our procedures have controls for validating design outputs with customer engineering department or designee.

The stuff we design is actually sent to our customer?s customer directly.
I would like to know if there is any problem if we do not validate the design with our customer, but directly with the end customer due to they know exactly what they want.

Based on the note saying that we have to validate design with customer engineering department or designee, I would think in those cases, that designee is the end customer.

As we are about to gather records for the certification process, I would like to know if this situation would become a gap during the certification audit, I do not see any restriction in the standard to proceed per my assumption.

Thank you in advance

There doesn't appear to be a restriction in the standard, but is your direct customer (the middleman, if you will) OK with this arrangement? I'm putting myself in their shoes; I would not be particularly comfortable with my vendor dealing directly with my customer, when I'm the one that is responsible for verifying that the product meets the requirements of what I ordered; I'm left completely out of the loop.

 

[Mario Alberto83]

...is your direct customer (the middleman, if you will) OK with this arrangement? I'm putting myself in their shoes; I would not be particularly comfortable with my vendor dealing directly with my customer, when I'm the one that is responsible for verifying that the product meets the requirements of what I ordered; I'm left completely out of the loop.

I would agree with you in some sense Miki, but it depends on the service/product provided, I would not be comfortable either if we were dealing with manufactured products (engineering already defined); however in this case, we are dealing with engineering definition (starting from concepts or ideas that could easily be wronged due to intervention of middlemen).

My direct customer initially took part of this validation, however it was a mess because my company has competent and knowledgeable personnel for dealing with engineering requirements and activities, while my customer does not.

Then, when our designs were approved by our direct customer, the end customer rejected; that?s why the communication channel was widen to end customer participation in the validation points.

Regards