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[…]
The role of GD&T in manufacturing today
In today’s era of rapid technological advancement, it’s easy to get caught up in the excitement of emerging technologies like artificial intelligence and quantum computing. However, the foundation of these innovations lies in fundamental engineering principles that have been honed over decades. One such principle, Geometric Dimensioning[…]
The revision of IATF 16949:2016
On the final days of October 2024, IATF announced that Stakeholder Communiqué SC-2024-006, IATF 16949 Revision 2 has been approved. The purpose of this Stakeholder Communiqué is to advise all IATF Stakeholders that IATF has started the revision process of the automotive quality management system standard IATF[…]
How’s Statistical Process Control evolving through automation
Statistical Process Control (SPC) has been a cornerstone of quality management for decades. It relies on the principle of sampling to estimate population parameters and monitor process stability. However, the advent of advanced technologies has fundamentally changed the way we collect and analyze process data. With the[…]
What to know about Ford’s New PPAP CSR
Ford Motor Company has announced significant updates to their Customer Specific Requirements (CSR) for Production Part Approval Process (PPAP), effective September 30, 2024. These changes aim to streamline the PPAP process and align Ford’s requirements with industry best practices. Ford’s Main Changes One of the key modifications[…]
Recent Post
ABC on ISO Nonconformity Identification
January 23, 2025
The basics of current Good Manufacturing Practices (cGMP) in Quality
January 13, 2025
