rubber product validation

Sealing Material Selection Guide: Rubber Product Validation (Part 4)

John StoneValue-Added Manufacturing

Rubber product validation is an important part of sealing material selection because designers need to know that a rubber seal will perform properly over the long term. Previous parts of this Sealing Material Selection Guide introduced some commonly used rubber materials (Part 1), material properties (Part 2), and product testing requirements (Part 3). Now that you know this information, it’s time to learn about rubber product validation and its relationship to variation.     

There are multiple sources of variation in the production of rubber sealing products: machines, tools, operators, materials, environments, measurement techniques, etc. Developing a robust validation plan is critical to controlling these sources of variation and ensuring the long-term goals of your sealing system. Knowing the critical features of the seal is part of controlling them properly in the process. Keep reading to learn more, or contact The Rubber Group to discuss the molded rubber parts that you need.

How to Ensure Long Term Part Performance

The table below lists items that are important to consider for product validation.

Validation ItemDescription
Critical to Quality Items (CTQs)Identifying the dimensional and/or material properties that are critical to your system’s function is crucial to developing a robust rubber product validation plan.
Gage Repeatability and Reproducibility (Gage R&R)Verifying that the measurement system can effectively evaluate parts in a consistent manner without operator variation in results guarantees that accurate results will be achieved in the long term.
Process CapabilityAcceptable process capability on CTQs is a robust way to verify that any variation in the process, tooling, and materials is captured in the data. This ensures that the rubber molder will be able to deliver in-spec parts over the long term. Sometimes, this could mean running multiple lots of material, multiple changeovers and/or different operators to capture all sources of variation.
Production Part Approval Process (PPAP)Documenting the dimensional, material and performance results in one package helps to ensure that all of this information is available in the future. Process flows, control plans, and Process Failure Mode and Effects Analysis (PFMEAs) ensure change and risk control over the process.
Medical Validation – IQ/OQ/PQ (Installation Qualification, Operational Qualification, and Performance Qualification

As a requirement for most medical projects, IQ/OQ/PQ is a very thorough way of ensuring supplier/customer agreement on the process and results. Processes are run at high and low gates for critical process parameters and tested accordingly. The other sources of variation are also included. The Rubber Group applies aspects of this process to non-medical parts as a best practice when warranted by the complexity and criticality of the application.
System Validation TestingTaking parts from the extremes of manufactured variation and testing them in the end process validates that the entire system will work as intended at all process extremes.

Get Help with Rubber Product Validation

Do you need help with rubber product validation? The Rubber Group has the capability to provide any measurement, test and validation that is important to your product. We also have deep experience with all types of validation and testing to support your product’s long-term process performance.  From basic dimensional information to full medical validation, we’ve got you covered for all your needs.

Do you need molded rubber parts or products? The Rubber Group can help you with material selection and optimize your sealing solution. We’re the manufacturing partner of choice for companies who want outstanding expertise in engineering and material science plus flexible capabilities for meeting sealing challenges. By treating customers, suppliers, and our fellow employees the way that we want to be treated, The Rubber Group is building long-term partnerships and achieving best-in-class service. We’re proud that our customers’ growth is fueled in part by leveraging our in-depth industry knowledge and unique capabilities. If you’re looking for a rubber molder that does more, contact us.