8.3.4.3 Prototype - what exactly prototype is?

[Blaz123]

Hi all,

I have a question related to point 8.3.4.3. Prototype programme. In this point is stated:

8.3.4.3 Prototype programme
When required by the customer, the organization shall have a prototype programme and control plan. The organization shall use, whenever possible, the same suppliers, tooling, and manufacturing processes as will be used in production.
All performance-testing activities shall be monitored for timely completion and conformity to requirements.
When services are outsourced, the organization shall include the type and extent of control in the scope of its quality management system to ensure that outsourced services conform to requirements (see ISO 9001, Section 8.4).

My question is, what prototype exactly is? By the word prototype, I understand a product that is made before the final confirmation of the product design (or later to) and is NOT the same as the first samples or PPAP parts.

Prototypes can also be made with completely different processes than will actually be used in series production - let's say that serial produced parts will be made with a plastic injection process and prototypes can be made with 3D printing.

Is my understanding of the word prototype correct?

 

[malasuerte]

Yes - you're interpretation is correct.

This clause is about "when the customer requires". In most cases, this would be if your org does not currently make the product 'currently'...the customer may ask for a prototype. So you would need ensure that the prototype is built in the same manner (or as close as possible) to the final product.

This is a funny clause in that a "prototype programme" is essentially defined for you in the clause itself.