At Amphenol Alden, we understand the value of certainty. That’s why our process validation solutions are designed to ensure part consistency from multiple angles to ensure you have the quality you need and the data to prove it.
Our experts run process validation for adhesive and epoxy application, over-molding, molded component trees, crimp termination and more. They work with you to measure every part using high-accuracy tools and deliver the answers you need to optimize parameters and equipment settings. Perhaps most importantly, their industry expertise enables them to anticipate and respond to data without delay.
How We Prioritize Process Validation
Many elements of manufacturing are complicated and challenging. Here, we believe process validation doesn’t have to be. Our approach to ensuring that your SOPs result in consistent, long-lasting parts is based on communication and expert measurements. We want to ensure that every part meets your specified process parameters, but we also help you understand where and when those parameters may be ineffective.
We begin by collaborating with cross-functional teams to determine which processes need to be validated. Based on our experience and expertise, we’ll interpret available information on failure risks associated with each assembly technique and the potential impact on part consistency and product service life.
Once we know what we’re validating, we’ll work with you to run a cost-benefit analysis for sample size. We’ll provide the insight and recommendations necessary to help you balance ROI and minimize raw material waste while generating more than enough data for statistical analysis.
To ensure our process validation always checks your boxes, we establish that your parts consistently meet print. Our teams combine physical inspections with advanced testing procedures for mechanical strength, electrical performance and more. We also run statistical analyses to ensure the feature variation is sufficiently tight, looking for a low probability of falling outside acceptable tolerance limits. This helps us provide the answers you need on optimized equipment settings, improved processes, maximized product service life and more.
Design and Process Validations
The Amphenol Alden team has expertise in a variety of process validation solutions spanning a wide range of assembly techniques, testing equipment and procedures, process limits and more. Examples of our offerings include:
Specialized Knowledge for Medical Applications:
Equipment Installation Qualifications ensure equipment functions at the highest level.
- Machine Function
- Electrical
- Hydraulics
- Software
- Preventive Maintenance Setup
Process Qualification (IQ/OQ/PQ)
AAP tooling undergoes Process Qualification to ensure every tool functions as designed.
- Max Settings
- Min Settings
- Nominal Settings
- Dimensional CPK>1.33
Process Qualification
AAP products undergo rigorous qualification to ensure the highest quality.
- Mechanical Testing
- Dimensional Verification Testing
- Electrical Testing
- Environmental / Reprocessing Durability