The 16 Key Areas of Automotive-Focused Requirements of IATF 16949:2016 That Go Over and Above That of ISO 9001:2015

IATF 16949, the industry specific quality management standard used in the automotive industry, illustrates a preference for all manufacturers in the supply chain to have a QMS that is certified against the standard...

The 10 CAPA Items that FDA Inspectors are Looking for During an Inspection

When inspecting a firm's CAPA process, the FDA publishes the following 10 inspection objectives as a flowchart for their inspectors to follow and make determination as to whether a firm’s CAPA process meets regulatory requirements:

Have You Implemented the Updated FMEA Requirements from the Latest Ford CSR?

The Ford IATF 16949 Customer Specific Requirements (CSR) were updated in November of 2021 with several important changes that became effective as of January 03, 2022 and were required to be implemented by July 1, 2022 for all programs that have not completed job 1 by that date.

Global Supply Chain Disruption

We are in the midst of what is being dubbed the ‘Great Supply Chain Disruption,’ a period that began with the Covid-19 pandemic in early 2020 and the infamous shortage of semiconductors around the same time, and has continued as the world has grappled with the resultant labor shortages and massive inflation

Weighing the Benefits of Transitioning to VDA FMEA: Addressing Weaknesses in the AIAG RPN

While there are plenty of online resources to deride the new format in favor of the AIAG 4th edition format that they’re used to, at IntellaQuest, we felt compelled to deep dive into some of the more positive aspects

What is PPAP?

PPAP is an acronym for Production Parts Approval Process, which is a formal method of production part approval from a manufacturer to its customer that was developed by and is widely used in the automotive industry, and has since found wide usage in many other industries as well.