Re: Design And Development Requirements (7.3) in TS16949
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.