Mold Validation

Why Validate a Mold?

Putting a new mold into production can sometimes be challenging. Simply accepting a mold from a tool maker without a validation process can lead to costly quality and production issues. The validation process can verify that the mold and process are capable of repeatedly producing quality components. In this process, a strategic data driven process is used to develop a robust molding process. At this point, the parts are assessed to ensure all fit, form, and function criteria have been achieved.

If parts meet quality criteria, the mold can now go into production, or further process development can continue to determine high and low settings. If parts do not meet the quality criteria, the root cause must be determined. This may lead to process adjustments or alterations to the mold. The process would then be repeated to ensure the changes were successful. This process essentially involves effort and resources at the beginning of the process, so that you save significant time, money, and resources in the long run.

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What We Can Do

• Process Development - This can be as simple as building a quick process to produce sample parts, or as complex as performing a series of specific experiments that use data to create outputs that create quality components.
• Design of Experiments – The Design of Experiments or DOE is performed to verify what processing components affect critical to quality part criteria.
• Installation Qualification – We can help verify that the mold is installed correctly. It is important that the machine the mold will be installed in is capable of producing parts.
• Operational Qualification – Operational Qualification or OQ verifies that the mold and process functions properly and produces quality product. Typically, the OQ verifies the high and low process settings.
• Performance Qualification – The PQ or Performance Qualification confirms the process is able to produce quality components over a long period of time.
• Project Management – We can handle not only mold validation, but the entire process: from tool build to machine and auxiliary selection, to a validated process. Whether it is a portion of the process or a turnkey solution, we can help.

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Mold Validation Benefits

Mold validation is a different approach to molding. Often times, molders save processes in a press. They load the program the next time the mold runs, and without process development and mold validation, they now spend time adjusting the process to meet quality criteria. As material viscosity shifts, this process is repeated until the run is complete.

Without mold validation, this situation can create excessive scrap, wasted material, wasted man hours, and down time, just to name a few. This results in a lost profit for you. With mold validation, you will see:
•A decrease in cycle time
•A reduced scrap rate
•An increase in production
•An increase in customer satisfaction

Key Objectives

Consistency: The validation process seeks to confirm that the injection molding process consistently delivers parts with the same quality attributes. This is crucial, especially in industries like automotive, aerospace, and medical devices, where precision and uniformity are paramount.

Cost Reduction: Early validation enables the identification and rectification of potential issues before full-scale production, thus reducing costly defects and waste. It is a preemptive measure to prevent production setbacks.

Regulatory Compliance: In industries like medical devices and pharmaceuticals, process validation often isn’t an option but a legal requirement. Compliance with these regulations is essential to avoid severe legal consequences.

Customer Satisfaction: Validation ensures that the products consistently meet or exceed customer expectations. This fosters trust and helps build a strong brand reputation.

Connect With Our Industry Expert, Marty Key

With over 20 years of injection molding, consulting and training experience, Marty Key helps customers improve molding operations and profitability. Offering a range of consulting services, Marty delivers proven solutions from eliminating processing headaches to solving organizational challenges.

Marty's extensive expertise and unique technical skills result in measurable manufacturing improvements.
• Training
• Part Validation
• Mold/Plant Design Review
• Process Improvement
• Manufacturing Support
• Quality Systems

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