Mold design validating how to

08-Apr-2020 13:24 by 4 Comments

Mold design validating how to

On the print for the product it is called out as a Class 1 device which requires a Cpk level above our arbitrary 1.66.Its validation revolves around those dimensions and that confidence level.

As an example, an injection-molded tongue depressor might only have three critical dimensions that need a validation: Length, width and thickness.

Now let’s say you are making a housing that has action in it, a circuit board and over-molded metal inserts.

The print has three notes that call for action once assembled, plus 45 critical dimensions.

The validation process starts once you have a working design and a manufacturer capable of completing the validation process.

At this point, you need to start the validation paperwork (IQ, OQ, PQ and possibly more).

In process capability statistical terms, Cp and Cpk must exceed, say, 1.66 for a risk level 1 product (arbitrarily chosen for this example) with an appropriate product sample rate during validation – including all secondary and tertiary documentation and testing. All aspects of the process must be validated to ensure that they result in the intended form, fit and function and that the process is capable of consistently meeting the required level of quality. A non-validated product does not have an assurance level of quality outside of in-process inspections, meaning that defects could be found within the manufactured lot.

A validated product, on the other hand, will have a high level of quality assurance; no defects will be found in the lot when validation is done correctly.

If we look at the whole design, there are round edges, but those were not called out as critical dimensions, so now they only need to be confirmed once, on a part to print.

Fewer measurements, most taken without a coordinate measuring machine (CMM), means a shorter validation time.

The part design must have realistic dimensions, with the critical-to-quality dimensions identified only as needed.

(Avoid details that add no value, such as a sunroof in Antarctica).

Anything that reduces the time spent in those two stages will save the most on the full validation time.

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