TC 176 Plans to Correct Mistakes Made With the Introduction of “Risk-Based Thinking” in ISO 9001:2015 | Opinion
The July issue of ASQ’s Quality Progress was one of the best issues I’ve read in a long time, with a much-appreciated emphasis on risk management and including a terrific article from Jayet Moon that served as an introduction to the new Quality Press book Foundations of Quality Risk Management, which is definitely now on […]
Recognition of EN ISO 14971 as a harmonized standard in support of the European Medical Device Regulations
Back in June, it was reported by TC 210, the committee responsible for medical device standards such as ISO 14971 and ISO 13485, that the European standard EN ISO 14971:2019 with its amendment A11:2021 had finally been cited in the Official Journal of the European Union (OJEU) as a harmonized standard in support of the […]
If you’re going to cite operator error, do it in the PFMEA
I have written often of my disdain for the tendency of some to blame the operator when things go wrong, and anyone who has worked with me or for me has heard me parrot exhortations ad nauseam to not blame operators for failure as to not rob yourself the opportunity to improve, but I think […]
IATF Updates FAQ 29 to Give New Guidance on Contingency Plans
On May 26th, 2022, the IATF posted that they had approved Stakeholder Communique SC-2022-008 Release of Sanctioned Interpretations (SIs) and Frequently Asked Questions (FAQs) related to IATF 16949:2016 and an SI for Rules 5th Edition, with the changes being effective in June. Of note, FAQ 29 was updated with guidance for developing effective contingency plans:
New FMEA Requirements in the Ford Customer Specific Requirements (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 in which there will need to be evidence of implementation for Tier-1 and sub-tier suppliers by July 1, 2022. I’ve included the entire revision table of the Ford […]
Free Whitepaper: Basics of ISO 9001:2015 Risk Management
Risk-based thinking is a new concept in the ISO 9001:2015 standard, and this has caused many companies to search for an easy way to manage the risk in their companies. By focusing on understanding your risks through a simple risk management process, you can focus your attention more on addressing the risks that are present […]