Validation Machine Process of “Crosslink, Low Profile Break-off” On Tornos Deco 20

Abstract

The United States (U.S.) medical device manufacturing sector is a highly diversified industry that produces a range of products designed to diagnose and treat patients in healthcare systems worldwide. Process validation is an essential part of medical device manufacturing. As an objective of this project there should be the completion of an operational qualification (OQ) to tests the process produces a consistent product that meet with the design specs and the qualification protocol (PQ) examines the capabilities of the current process in producing a safe, high-quality product under simulated conditions of Crosslink Low Profile Break-off. After the qualifications runs the data will be gather to analyze if the data follows a Normal Distribution, then will be calculate the Tolerance Intervals, the ANOVA’s, Capabilities, Sampling Size and the Control Limits for each of the critical dimensions. Key Terms - Control Limits, Operational Qualification, Performance Qualification, Validation, Low Profile Crosslink, Spinal.