Have you ever taken your car into the shop for a simple fix, only to find yourself bogged down with “helpful recommendations” that somehow all end with you paying thousands of dollars for tests you’ve never heard of? Sometimes, you don’t need “the works,” you just need the car to keep driving.
Unlike a questionable mechanic, trustworthy converters do not want to throw “the works” in terms of quality inspections at every project. Instead, they only want to perform the validation or verification processes your product needs. For a simple part design, this may consist of checking product specifications as they’re made. However, complex projects often involve multiple stages of testing outlined in a mutually agreed upon Quality Plan.
At Strouse, we are committed to establishing a production process that ensures quality and consistency in every part and will work with you to establish a program that is right for your project. At your request, Strouse can provide pre-production testing and validation services, including PPAPs (production part approval process), FAIR (first article inspection reports), and Process Validations.
Whether you’re prepared for process validation or unsure where to start, this article will help you get a basic understanding of what to ask when discussing it with your converter.
Pre-production activities like process validations, trial runs, or other pre- or first-run evaluation and reporting can be crucial in assuring that your product's manufacturing process is fully established, adequate, and repeatable. These activities also lay the groundwork for compliance, product safety, and risk management.
Every converting project undergoes process validation to some extent, but the complexity depends on your product’s requirements and expectations.
At Strouse, every production run follows a control plan that starts with a First Article Inspection, also known as a Setup Inspection. This process ensures we verify the product's conformance before full-scale production begins.
A production run starts with the machine operators setting up the machine, making adjustments as needed, and producing initial parts. The setup and first articles will then be reviewed by the operator and a member of the quality assurance team. If everything is in order and the first articles are conforming, then the go-ahead is given for production to commence.
During production, the operator pulls samples at prescribed intervals to inspect against specifications and to perform any functional testing, such as liner release, perforation tearing, etc.
At the end of the run, the operator inspects final samples for conformance and requests QA (Quality Assurance) review. A representative of the QA team reviews final articles, the run record, packaging, and labeling for adherence to the requirements before approving release for shipping.
As product designs become more complex and require stricter controls, additional activities might be necessary or desired. These processes can become costly, and because they aren’t necessary for every product, it’s important to discuss your specific project requirements with your converter.
Depending on your project needs, you may want to consider the following.
One option is a First Article Inspection Report (FAIR) to precede or accompany your first delivery of product. This report includes:
Another option is a PPAP (Production Part Approval Process) or similar exercise. These types of efforts are usually more in-depth than a FAIR and typically include:
A third option is Process validation.
You may hear three pillars commonly referenced when discussing process validation: IQ, OQ, and PQ.
In broad strokes, IQ includes:
OQ involves:
This phase serves to refine the production process.
During PQ the manufacturing process is executed as normal.
PQ often includes repeated production runs.
Re-validation might be warranted under the following conditions:
If none of these are exactly what you are looking for, Strouse is happy to create a custom solution that fits your needs.
So, it’s time to define your testing and validation requirements—where should you begin?
Above all else, a clear and comprehensive explanation of your product expectations and specifications will help your converter understand how you hope to receive the product.
What is the part trying to do? What does a successful part look like? What can get in the way of making a successful product? Are there any specifications on the drawing that are more critical than others? Are the tolerances “functional” tolerances?
If you’re ready to discuss product validation, reach out to Strouse today. Discussing your project will allow us to help determine the best methods to meet your product goals.
Regardless of where you are in your journey, Strouse’s experts can help you navigate a smooth product development process and create a fully optimized process design for production.
For additional resources on how we can help you with your product development, check out our material selection or prototyping guides. Lastly, contact us with any questions about our validation process and capabilities.