RISK MANAGEMENT OF CLASS 3 ELECTRONICS AS A FUNCTION OF CLEANLINESS

摘要

In the design and development of safe, effect devices, reducing risk, and ensuring reliability are a manufacturer's first responsibility. The advanced technology inherent in Class 3 hardware and their production means that all aspects of the system - including mechanics, electronics, software, and hardware must be evaluated for reliability. Every aspect of its development - from design and prototyping through manufacture, distribution, disposal, and decommissioning must adhere to strict quality standards that are documented and traceable to functional and safety requirements. Risk management involves the systematic application of policies, procedures, and practices to the task of analyzing, evaluating, controlling, and monitoring the risk inherent in Class 3 hardware. Risk management is an iterative process that should assess all aspects of the product's lifecycle and must be implemented and documented throughout the design, development, prototyping, manufacture, and phases of a product's lifecycle to ensure that no new or unexpectedly severe risks go unmanaged. Electronic assemblies are prone to intermittent and total failure from process contamination. Testing is needed to qualify solder materials, reflow conditions, and cleaning processes. Contamination trapped under leadless components is highly problematic due to the pitch reduction, shadowing effects of high components next to bottom terminated components, actively of residues, voltage bias, and environmental exposure. The purpose of this research paper is to apply risk management to contamination. The designed experiments are focused on improved methods for proving out and developing better methods at the point of the manufacturing process for qualifying soldering and cleaning processes that result in acceptable levels of flux and other residues.