ABC on ISO Nonconformity Identification
In the dynamic landscape of medical device manufacturing, maintaining a robust Quality Management System (QMS) is paramount. At the heart of any effective QMS lies the ability to effectively identify and address nonconformities – deviations from established procedures, standards, or requirements defined within ISO 9001. This article[…]
The basics of current Good Manufacturing Practices (cGMP) in Quality
Quality is paramount in manufacturing. It directly impacts customer satisfaction, brand reputation, and overall business success. Current Good Manufacturing Practices (cGMP) provide a robust framework for achieving and maintaining high product quality throughout the entire manufacturing process. What are “cGMP”? cGMPs are a set of guidelines and[…]
The Value of Pareto Charts in Quality Control
In the dynamic world of quality engineering (SQE), identifying and addressing root causes of defects is paramount. While a multitude of tools exist, the Pareto chart stands out as a visually compelling and data-driven approach. Inspired by the 80/20 rule, the Pareto chart emphasizes that a small[…]
Understanding Taper Pipe Thread Inspection
National Pipe Taper (NPT) threads are a common type of tapered pipe thread widely used in various industries, including plumbing, hydraulics, and gas lines. These threads are crucial for creating leak-tight connections, ensuring proper system functionality, and maintaining safety. Understanding NPT Threads The Role of Supplier[…]
Material Testing Evolution Towards 2025
Supplier Quality Engineers (SQEs) play a critical role in ensuring the safety and efficacy of medical devices, including catheters. Their responsibilities extend beyond simply inspecting incoming materials; they must deeply understand the manufacturing processes and the rigorous testing protocols that ensure product quality. This article focuses on[…]
Quality Control Through Compression Testing: A Guide for SQEs
Quality control is a cornerstone of manufacturing excellence, and compression testing plays a pivotal role in ensuring product reliability and safety. As a Supplier Quality Engineer (SQE), understanding the principles and applications of compression testing is essential. What is Compression Testing? Compression testing is a mechanical process[…]
Applying Kaizen in Mass Customization
In today’s dynamic market, organizations must adapt to meet the ever-evolving demands of their customers. Mass customization, a strategy that combines the benefits of mass production with the flexibility of custom-made products, has emerged as a vital approach to achieving this goal. While technology plays a crucial[…]
Chart types within statistical process control (SPC) and when to use each one
Regarding statistical process control (SPC), attribute charts are invaluable tools to manage data categorized as attributes.
PRE-Control: A Simple Yet Powerful Tool for Supplier Quality Engineers
In the world of manufacturing, ensuring product quality is paramount. One effective tool for achieving this is PRE-Control. This technique empowers shop operators to maintain process control and prevent the production of defective parts. Unlike statistical process control (SPC), which requires a significant amount of data before[…]
101 on structuring a reliable calibration system
Calibration is more than just a technical process; it’s a promise to customers that products will meet their expectations.
Recent Post
ABC on ISO Nonconformity Identification
January 23, 2025
The basics of current Good Manufacturing Practices (cGMP) in Quality
January 13, 2025
