Manufacturing Process Design and Development Review - TS 16949 Clause 7.3.4

[qusys]

Well, I put a example of using two machines instead of 1, what I needed to hear was: "yes, that's how you review, verify and validate; that's how you met 7.3.4, 7.3.5 and 7.3.6"

so, i guess I'm on the right path, I'll review the plans, I'll verify if the process gives the expected results and validate if the process is being doing it the way we planned.



Thanks everyone.

I would like to highligh that the point 7.3.4.1 is important for monitoring this process. A report of analyis shall be produced by the organization at specific stages and this is an input to management review too.
This could be an output of the design review of the manufacturing process design and development.

 

[qusys]

Well, I put a example of using two machines instead of 1, what I needed to hear was: "yes, that's how you review, verify and validate; that's how you met 7.3.4, 7.3.5 and 7.3.6"

so, i guess I'm on the right path, I'll review the plans, I'll verify if the process gives the expected results and validate if the process is being doing it the way we planned.



Thanks everyone.

As to review, validation and verifications step , they shall be planned at a certain stage and considered as milestones in a project management approach for new products introduction.

Reviews for mgf process design and development are related to the quality, cost and times of the project. Reviews shall be sistematic , done in multidisciplinary approach and recorded to have evidences.

verification can be done performing alternative calculations, undertaking demonstrantion including prototyupes, tests, simulation , reviewing documents.
it is more technical than review, which is more related to the management of the project.

Validation differ from organization to organization.
For example you can validate the process testing a prototype, followed by testing of initial samples of finished products.
At the end the validation of mfg process design and development shall assure that there is in place a process of checking that the process is ok to produce a product that meet customer's needs.

 

[homenet1]

Hi!

I am trying to understand the section 7.3.4.1 w.r.t. " critical paths and others".

Can anyone, please, explain this and how to get data for critcal paths?

Thanks.