We are manufacturing for plastics parts (Injection moulding) and going to TS16949. We are not responsible fot product design as we are produce according to customers design(the tools are for customer) , we are set some parameters of our machines according to raw material supplier instruction and other parameters based on our experience..
MY QUESTION IS..

Can we exclude all the clause 7.3 and its sub clasues of TS requirement (Design and development).

Many thanks in advance.

Hamed

Hamed,

Under TS, Requirements:
1. Do you have any thing to say about design input or do they gave you the drawings and specs.

2. Does your customer furnish you a copy of the design fmea.

3. Tooling, PF, CPLN, pfmea, is your responsibility this is stated in 7.3.2 - thru- 7.3.5. This is the part you have to comply with alonmg with joint planning from your customer design fmea. and the following:

4. Under 7.3.6 for test and validation the run@rate and run time for tooling
between prototype and prodution. (or what is set in contract)

5. section 7.3 only what pretains to process not design.

Hi Hamed - FYI - I edited your thread title to be more specific in hopes it will get better responses.

Thank you for your response

Customer giving us the drawing and full product specification. we are creat PPAP (PFMEA) which approved by the customer.

How can we cover the requirement (CL 7.3.6 in TS )

Many thanks,

Hamed

Thank you for your response

Customer giving us the drawing and full product specification. we are creat PPAP (PFMEA) which approved by the customer.

How can we cover the requirement (CL 7.3.6 in TS )

Many thanks,

Hamed

Hamed.

You demonstrate that the (designed) process is capable of meeting requirements. That validates it.

See also World Quality's excellent post #2

Stijloor.

We are manufacturing for plastics parts (Injection moulding) and going to TS16949. We are not responsible fot product design as we are produce according to customers design(the tools are for customer) , we are set some parameters of our machines according to raw material supplier instruction and other parameters based on our experience..
MY QUESTION IS..

Can we exclude all the clause 7.3 and its sub clasues of TS requirement (Design and development).

Many thanks in advance.

Hamed

Hamed,

Good question. In TS, you don't exclude the whole clause, 7.3. You can exclude the Product Design Process. However, you still have to take care of the Process Design activities and validation.

Hamed,

Good question. In TS, you don't exclude the whole clause, 7.3. You can exclude the Product Design Process. However, you still have to take care of the Process Design activities and validation.

Helmut,

While the customer has indeed designed the end product, Hamed's company still has to design the tool to make that part. This can be a very complicated process, allowing for part shrinkage, designing a flow path that will not introduce weaknesses into the part, etc.

Would this fall under the Product Design activities or the Process?

Either way, his system must cover it. He cannot exclude it as you stated above.

Helmut,

While the customer has indeed designed the end product, Hamed's company still has to design the tool to make that part. This can be a very complicated process, allowing for part shrinkage, designing a flow path that will not introduce weaknesses into the part, etc.

Would this fall under the Product Design activities or the Process?

Either way, his system must cover it. He cannot exclude it as you stated above.

Generally is considered part of Process Design, even if it is outsourced. And yes, the organization cannot exclude it.

The tools are given by customers (thier tools), I have mentioned below what I have wrote in our quality manual, I'll be appreciated if any one can review and give me his comments:
'' Since WHS-PE is not designing any product but only produces according to the customer requirements, also the manufacturing process design is according to the material suppliers instruction, hence clause 7.3 is not applicable. (Refer Section 1.3 – Exclusion)
Another question How can I validate the process? (CL 7.5.2)

Many Thanks for all,

Hamed

The tools are given by customers (thier tools), I have mentioned below what I have wrote in our quality manual, I'll be appreciated if any one can review and give me his comments:
'' Since WHS-PE is not designing any product but only produces according to the customer requirements, also the manufacturing process design is according to the material suppliers instruction, hence clause 7.3 is not applicable. (Refer Section 1.3 – Exclusion)
Another question How can I validate the process? (CL 7.5.2)

Many Thanks for all,

Hamed


NO we cannot exclude the whole 7.3.2 in TS because it covers product as well as process design. Product design is not in your scope but you are owner of process design.
Product design input ( PDI) is only excluded. But Process design i/p is valid for you.

Imagine excluding whole 7.3.2, how will the org. work because : -

7.3.2 also covers

1. Manufacturing process design input
2. Special characteristics

Also i think the exclusion statement says that exclusions include only 7.3.2 related ( not whole 7.3.2)

Rest about injection molding machine

1. Based on i/p material its MFI, elongation, density we set the machines.
2. validation parameters are Inejection time, Holding pressure, Cooling time, Mold temperature etc. leading to desired o/p.

Validation will be done by either
1. selecting ket i/p parameters such as cooling time, Injection pressure, Injection speed , Holding time/Pressure ----------- ( Partial validation)

2. Covering all parameters that impact quality of molded part like Mold Temp., Clamping force, etc. ----------------- ( Full validation)

But as per system validation means complete validation ( case 2 above)

validation will be done by trial & error &by alternate software if you have any l: -


input by Mold flow analysis software followed by its run for corrections.

Rest as you know validation will be considered on setting that will lead to optimum quality, cost.