image courtesy of Verus
Most of our readers will probably be very familiar with First Article Inspection (FAI) and why it's important. Nonetheless, a simple and very well explained guide by Verus Metrology Partners prompted me to write this short introduction to FAI. You can read Verus' article, 3 Essential Steps for First Article Inspection (FAI) here.
FAI is a process in which either the very first component that is produced, or a sample component from the first batch of production, is measured against the design specifications of that component. It's usually a purchase requirement from the buyer, with the responsibility belonging to the producer. If the buyer demands it, or if the producer cannot provide it, the FAI process may also be outsourced to an external dimensional/inspection metrology specialist. Essentially, the idea is that a customer will order a large amount of components, but before finalising the purchase, they want to have proof that the product is made within acceptable accuracy parameters, and FAI shows them exactly that.
The FAI process may be used for a number of different reasons in the manufacturing process. Not only is it when a customer receives a new product, but it may also be used when there is a design change to a product, or if there is a change in the way it's manufactured, or even if there is a change in the location where it's manufactured. Essentially, any variable that may affect the accuracy of production may warrant another FAI.
If the product, or article, passes the FAI, that means the line is then ready for full-scale production.
Verus outlines the three essential steps for optimising FAIs as the following:
1. Partner with an experienced FAI service provider.
2. Produce first articles using the full manufacturing process.
3. Create a detailed plan.
Although Verus' article focuses specifically on the production of medical technologies, it applies pretty much to all manufacturing processes that have narrow accuracy parameters. A trusted, experienced provider is guaranteed to deliver good results. Using the full manufacturing process eliminates unforeseen variables by creating a true representation of the planned article. Finally, creating a detailed plan for the FAI ensures that the results are as close to truth as possible, in the required parameters: all necessary points are measured to the right accuracy and with repeatability taken into account, this method should deliver.
In Verus' words:
"In highly regulated industries like MedTech, FAIs are commonly part of the compliance process, so they are an essential part of moving a component or device from the design stage to full-scale production.
Therefore, FAIs need to be successful. Not in the sense of achieving an FAI pass, but in the sense of the process and report meeting the requirements of your business.
FAIs can go further, too, adding value to this phase of your project and delivering a return on investment by, for example, identifying areas where improvements can be made to reduce manufacturing costs."