The quality we keep: measurement & validation requirements

Profile’s quality system quantifies and evaluates several different customer requirements. We can focus on different areas at the customer’s discretion.

Our capabilities for measurement, inspection, and validation documentation include:

• First Article Inspection Reports (FAIRs)
• Production Part Approval Process (PPAP)
• Process Capability Analysis (Cpk)

Quality processes

FAIR: A first article inspection (FAI) makes sure it meets design specifications before production. The FAIR verifies initial part samples. A full FAIR validation is done for a new product introduction: reviewing the design, the manufacturing process, and all documentation. Later, a partial or verification FAI is performed for changes to existing products or changes in the production cycle.

A first piece approval reviews a sampling of the new part direct from the production line after a change is made. As part of the FAIR process, sample sizes can range from 1-5 parts.

PPAP: This quality measurement provides assurance that the entire production process can produce parts that will consistently meet requirements throughout the life cycle. It shows that we can scale up production to fulfill your order.

Customers tell us the level of PPAP that they want us to meet successfully. There are 5 levels of stringency, based on submission and documentation requirements. These range from a submission warrant (certificate), to warrant and samples, up to warrant and samples with supporting data and on-site review.

Process Capability Analysis: Using data from an initial production run allows us to predict whether the process can produce parts that repeatably and reliably meet specifications. It measures how consistently parts are produced within specifications. Customers can request this study as part of a PPAP.

The Cpk value measures the center of the process as well as the range relative to the specification tolerances. A higher Cpk number indicates that a process is more capable of consistently producing parts within limits, leading to fewer defects and better quality.

Summary

The Profile Plastics QMS is designed to provide you with total assurance. We measure our commitment to quality by meeting or exceeding your requirements and providing consistently reliable thermoformed parts.