Dear all,

I have a silly question. I was questioned/challenged by a colleague that if the assemble of a functional prototype shall be considered as a production process. We are a design house for consumer products. We will design the product according to the customer ideas and we will deliver not only the design documents/drawings but also functional prototype for demostration purpose only (after receiving the design and the prototype, our customer will do their production). So the question is: is the purchasing of components and assemble of the prototype be considered as a production process and shall be controlled by 7.4 and 7.5 in ISO9001?

Thanks for any comment in advance.

Alan AU

Dear all,

I have a silly question. I was questioned/challenged by a colleague that if the assemble of a functional prototype shall be considered as a production process. We are a design house for consumer products. We will design the product according to the customer ideas and we will deliver not only the design documents/drawings but also functional prototype for demonstration purpose only (after receiving the design and the prototype, our customer will do their production). So the question is: is the purchasing of components and assemble of the prototype be considered as a production process and shall be controlled by 7.4 and 7.5 in ISO 9001?

Thanks for any comment in advance.

Alan AU

Hello Alan,

If your business consists of the activities as you have descibed them, then yes, you could consider the "production" of functional prototypes a "production process" and 7.5 applies. In your case; 7.3, 7.4 and 7.5 are applicable.

Stijloor.

Then on the other hand, can we exclude them?

Then on the other hand, can we exclude them?

You may exclude 7.5 because you do not "produce" in the sense of what a manufacturing plant would do. You must justify this in your Quality Manual. However, 7.3 and 7.4 apply and can not be excluded.

Stijloor.

Dear all,

I have a silly question. I was questioned/challenged by a colleague that if the assemble of a functional prototype shall be considered as a production process. We are a design house for consumer products. We will design the product according to the customer ideas and we will deliver not only the design documents/drawings but also functional prototype for demostration purpose only (after receiving the design and the prototype, our customer will do their production). So the question is: is the purchasing of components and assemble of the prototype be considered as a production process and shall be controlled by 7.4 and 7.5 in ISO9001?

Thanks for any comment in advance.

Alan AU

In complex structural engineering design, we often carry out 'validation' of design by building either scaled or full scale prototypes to validate design assumptions, etc. Therefore, if you are a design house (of whatever), I think you can consider it as 'validation' of design.

It is called a prototype or mock-up (better term) because it was built to prove or show certain features and not as a complete product (eg. just tack-weld instead of full weld) or to full specification. Therefore, you can exclude 7.5. Sometimes building of prototype or mock-ups are part of the customers responsibility, in which case 7.4 does not apply.

Please note the difference if the manufacturer were to do it - then, it's considered as first article because the purpose is to validate the manufacturing process, etc, etc. In this case, clause 7.4 & 7.5 is relevant.

You may exclude 7.5 because you do not "produce" in the sense of what a manufacturing plant would do. You must justify this in your Quality Manual. However, 7.3 and 7.4 apply and can not be excluded.

Stijloor.

Dear Stijloor,

So in your suggestion, the purchasing of the components for the prototype should be controlled as well. In our case, we subcontract the sourcing work and if the purchase of components need to be in the scope, then we have to prepare the procedure.

Thank for your advice in advance.

Alan AU

Dear Stijloor,

So in your suggestion, the purchasing of the components for the prototype should be controlled as well. In our case, we subcontract the sourcing work and if the purchase of components need to be in the scope, then we have to prepare the procedure.

Thank for your advice in advance.

Alan AU

Hi Alan,

If you outsourced the purchasing process, then you still have to ensure control over that process. Look at the last paragraph in Clause 4.1. A documented procedure is not required, you just have to identify this process per 4.1 a) and ensure that your supplier has a good understanding of what it is you need. You have probably a contractual agreement with this organization?

Hope this helps.

Stijloor.

Hello Alan,

If your business consists of the activities as you have descibed them, then yes, you could consider the "production" of functional prototypes a "production process" and 7.5 applies. In your case; 7.3, 7.4 and 7.5 are applicable.

Stijloor.


Suddenly, I have another thought. What if we have to demonstrate the internal circuit design. We will have to make a prototype to demonstrate the circuit design (verification) but we are using the similar electronic components (in terms of brand name and model) according to our open BOM. Shall we go through all the controlled procedure of the purchasing of those components for the prototype. Bear in mind that when in manufacturing, production staff will use another model, may be cheaper, of components in the mass production.

Thanks

Suddenly, I have another thought. What if we have to demonstrate the internal circuit design. We will have to make a prototype to demonstrate the circuit design (verification) but we are using the similar electronic components (in terms of brand name and model) according to our open BOM. Shall we go through all the controlled procedure of the purchasing of those components for the prototype. Bear in mind that when in manufacturing, production staff will use another model, may be cheaper, of components in the mass production.

Thanks


If your situation is that unique, you might consider a separate procedure or section discussing how you want to control those unique aspects that apply when you build Prototypes.

What is this obsession with identifying exclusions? :confused:

As described the OP has a core process that is both control of design and provision of a service that happens to deliver products in the form of drawings and prototypes.

Write the system up as it works for your organization and then at the end when you come to check (against ISO 9001) whether you have any exclusions you will probably find there are none.

If your situation is that unique, you might consider a separate procedure or section discussing how you want to control those unique aspects that apply when you build Prototypes.


Dear hjilling,

Thanks. So do you think that I can skip the control of the sourcing of component for building the "functional" prototype.

Best Regards,

Alan AU:confused:

Dear hjilling,

Thanks. So do you think that I can skip the control of the sourcing of component for building the "functional" prototype.

Best Regards,

Alan AU:confused:


No, It's not that simple. On the one hand, your core activity is the building of prototypes. That has to be controlled approrpiately. On the other hand, building prototypes is a unique, one-off situation, different than regular production.

I think Paul Simpson gave good advice. Don't focus on exclusions. That is a small concern. Focus on what is appropriate to your business, and write your procedures to address the flexibility needed to make prototypes. Don't just write basic procedure.

Then, if there are any 100% exclusions, write them out and explain why they are excluded. You can have a method or procedure for a function that does not occur often. The rest of the time, it is dormant.