Is Zero Defects a Worthwhile Quality Target?
Introduction The concept of ‘zero defects’ has been a popular catchphrase in quality management and continuous improvement circles for decades. This aspirational goal implies that a production process or service should aim for perfection, with the ultimate objective of producing defect-free products or services. However, as noble as this objective may seem, it often falls […]
What is the Aerospace Improvement Maturity Model (AIMM)?
The IAQG, or International Aerospace Quality Group, who is responsible for developing standards throughout the aerospace supply chain, has created several tools to make the understanding and implementation of their standards easier. One such tool is the Aerospace Improvement Maturity Model, or AIMM, a tool that is freely accessible from the IAQG website. From the […]
FDA Issues ICH Final Guidance for Continuous Manufacturing (CM) and Artificial Intelligence (AI) in Drug Manufacturing
The FDA is seeking public comments on the use of artificial intelligence (AI) in pharmaceutical manufacturing. As the use of AI continues to grow across industries, drug manufacturers are also looking to adopt AI-based technologies to improve drug discovery, formulation, process development, and quality control. According to a recent article on Endpoints News, the FDA […]
The Four Key Elements of a Successful Culture of Quality Improvement and How They are Addressed in ISO 9001
Creating a culture of quality improvement is crucial for any organization seeking to achieve excellence in its products or services. In an excellent article from Boston Consulting Group, Boudier and Bowers provide several key insights into creating such a culture. We explore the four key elements that they identified as being necessary for the successful […]
2022 Top 10 IATF Major and Minor Nonconformities Compared Year-Over-Year
IATF has published their year-end statistics for top 10 major and minor nonconformities raised during CB audits from December 2021 to December 2022. We’re taking a look back at the year-end statistics from 2021 to see how things have changed over the last 12 months. The top 10 major nonconformities from 2021 compared to 2022 […]
GM Releases Updated IATF 16949 Customer Specific Requirements Effective January 1, 2023
On December 22nd, General Motors published their updated IATF 16949 Customer Specific Requirements, with the new CSR taking effect on January 1, 2023. The full table of changes is in the image below. Aside from the replacement of BIQS requirements with GM Quality Performance Requirements, the most noteworthy change is the note: “Throughout the document: […]
IATF Releases Communique Requiring CB Auditors to Complete AIAG/VDA Harmonized FMEA Training by Q1 2023
In December of 2022, IATF published CB Communique 2022-03 – AIAG VDA Harmonized Approach to FMEA to outline details for new IATF ADP mandatory training and quiz requirements for CB auditors. New AIAG/VDA harmonized approach to FMEA training and quiz modules were made available for CB auditors starting on December 7th of this year and […]
What a QMS Isn’t: Two Common Misconceptions When Implementing a QMS
Being in the QMS consulting business, we get to work with all sorts of clients from various industries who want to implement or improve their quality management systems starting from various levels of maturity. Some have systems in place but are looking to make them more robust or more reflective of their processes, eliminating redundancies […]
OEM EV Saturation Forecast for 2023 and Beyond
The OEMs’ drive to convert internal combustion engines to EVs continues to quicken, resulting in a diverse set of new components and materials for the industry, establishing a new and unique supply chain. Many new suppliers bring along new issues as a result of the conversion. Everyone accepts that the conversion must happen, and few […]