Want 40% Faster Cycle Times with 90% Less Scrap?
What many miss in manufacturing isn’t just mold validation; it’s process validation. Most follow tooling validation, which gives you a mold capable of producing acceptable parts. But it doesn’t guarantee a process that consistently produces those parts within required limits.
After 20+ years in the industry and thousands of tryouts, I’ve seen mold validation used to qualify the process only twice. In FDA-regulated environments, validation is a requirement, but in automotive and consumer goods, it’s rare. Why?
How to Tell if Your Process is Truly Validated
Did you use these tools?
Process validation is a structured approach with three key stages: Process Design, Process Qualification, and Continued Process Verification. Here’s a breakdown:
1. Design of Experiment (DOE)
DOE identifies relationships and sources of variation quickly. It’s essential to determine if this step is worth it through a cost-benefit analysis. If you skip DOE, you haven’t fully validated the process.
2. Quality by Design (QbD)
QbD ensures quality is built into products from the beginning, not just tested at the end. Especially crucial for critical molding processes, it allows early-stage design adjustments to address potential risks and quality issues before they arise.
3. Process Analytical Technology (PAT)
PAT measures critical process parameters (CPP) and critical quality attributes (CQA) in real-time, allowing for timely feedback and adjustments. It’s used both in design and production to ensure a process stays within qualification standards.
4. Critical Process Parameters (CPP)
These are the operating parameters essential to keeping the product within quality guidelines. Monitoring CPP ensures output remains consistent.
5. Critical Quality Attributes (CQA)
CQAs are the attributes necessary for defining product quality, and monitoring these ensures that the final product meets all required standards.
6. Design Space Verification
This step confirms that quality can be maintained within a defined range of input and operating variables, providing a safeguard against variability.
7. Process Qualification
At this stage, the process design is evaluated to ensure it meets production goals. Equipment and production processes are proven to deliver quality outputs, setting the foundation for consistent manufacturing.
8. Continued Process Verification
Ongoing monitoring throughout production to ensure everything remains within control. Deviations are flagged and adjusted to maintain consistency.
Benefits of Following This Process
- 40% Faster Cycle Times
- 90% Less Scrap — triple savings on materials, time, and costs
- Double the Unattended Production Hours
- Higher PPE Turnover
What’s the Cost of Implementing This?
If you’re not already following these steps, you're likely paying for it threefold in inefficiencies and quality issues. Investing in a comprehensive process validation can save you time, materials, and resources—delivering a process that produces acceptable parts within limits, every time.
