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Validation

Prove, before the mold is delivered, that the mold makes parts that meet or exceed Cpk requirements.

Validation Process Methodology

The Algoryx Mold Characterization Study “condenses” all part dimensions in all cavities down to a single dimension in one cavity. That single dimension is the Predictor Dimension.

“Condensing” all dimensions from all cavities down to the single Predictor Dimension in one cavity greatly reduces the amount of work that must be done during validation. “Condensing down” from many dimensions to the single Predictor Dimension is done during the development phase.

All dimensions in all cavities are normally measured during validation. This can be very costly and very time-consuming. With Algoryx, only the Predictor Dimension is measured. This results in a huge reduction in the number of measurements.

SPC analyses (to prove stability) are normally done on all dimensions in all cavities during validation. With Algoryx, SPC analysis is done only on the Predictor Dimension. This results in a huge reduction in the number of SPC analyses.

Process capability (Cpk) analyses are normally done on all dimensions in all cavities during validation. With Algoryx, process capability analysis is done only on the Predictor Dimension. This results in a huge reduction in the number of process capability analyses.

Operating Capability

With Algoryx, process capability analysis is done to determine Opk. In the Algoryx methodology, Opk is operating capability. Opk is calculated using the same formulas as Cpk except that the Upper and Lower Operating Limits are used for the Predictor Dimension instead of using the upper and lower specification limits for each critical dimension.

Multiple Validation DOEs

In most industries, validation must be repeated each time the mold is moved from one press to another. In some industries, the mold is moved in a series of steps from high technological capability production facilities to lower technological production facilities. Validation must be repeated each time the mold is moved.

The Algoryx Mold Characterization Study results are press independent. This means the Mold Characterization Study results travel with the mold from press-to-press, region-to-region and country-to-country.

There is no need to repeat the entire validation process each time the mold is moved. The Operating Range and Operating Target remain unchanged. When the mold is moved to a new press, the press is adjusted so the Predictor Dimension is at or close to the Operating Target. The press is then run in production and Opk is calculated using only the Predictor Dimension.

Validation Savings

  • Validate by measuring only the Predictor Dimension.
  • Do SPC analysis on only the Predictor Dimension.
  • Do capability analysis on only the Predictor Dimension.
  • Use the Mold Characterization Study results to eliminate most of the validation work when the mold is moved to a new press.

Algoryx Reduces Medical Validation Risk

Some medical device OEMs require the validating organization to first perform a “big box” DOE followed by a “process optimization” DOE. In the medical industry, each DOE typically consists of 72, fully randomized shots. That is a total of 144 validation shots.

Medical molds can be high-cavitation molds to achieve manufacturing efficiencies. Medical molded parts can have a relatively large number of critical dimensions to ensure safety. A 128-cavity mold with 17 critical drawing dimensions means 2,176 part dimensions per shot.

The grand total of the product of 144 validation shots and 2,176 part dimensions per shot is 313,344 measurements! And, this for only one validation cycle.

Some medical device OEMs allow the validating organization to “validate” the mold by meeting only First Article requirements on a large percentage (typcially 80%) of the cavities. The validating organization does not have to prove that the mold is capable on 80% of the cavities.

This introduces risk. Each cavity is physically different. The flow path is different to each cavity. The plastic experiences different pressure, temperature, velocity/viscosity profiles to each cavity. These differences result in part dimensional differences from cavity-to-cavity.

Validation costs are reduced but with the consequence of substantially increased risk. This risk has at least two manifestations. First, the end user may suffer harm. Second, out-of-specification parts may cause assembly line shut-down in automated assembly plants.

The Algoryx methodology eliminates the risk of not doing a full validation on all critical dimensions in all mold cavities.

Take the Algoryx Challenge – See the results using your validation data!