by Linda Stein | Oct 2, 2018 | Automotive, Safety
It’s been a long time coming, but the eagerly awaited second edition of ISO 26262 will soon be released. One of the topics that has led to much discussion over the years, since the first edition was released, is the usage of the tables defining methods and techniques...
by Linda Stein | Sep 19, 2018 | Rail, Safety
In our previous blog, “Keeping Safety on track in the Rail Sector”, we looked at the benefits of marrying the Cone of Uncertainty concept with the Reliability, Availability, Maintainability and Safety (RAMS) lifecycle. This enables us to assess more accurately the...
by Linda Stein | Aug 29, 2018 | Rail, Safety
Another busy morning in the office, coffee poured, all set for the day ahead. An email arrives asking for sign off to authorize a new release of a safety critical electronic control board on an in-service train. I could do the sign off in the blink of an eye, but am I...
by Linda Stein | Jun 26, 2018 | Medical Devices
In our previous blog on the Medical Device Regulation (MDR) we focussed on how the MDR will support safer product development. In this blog we look at the alignment of the MDR with best industry practice and the current maze of medical device standards. The MDR Annex...
by Linda Stein | Feb 6, 2018 | Automotive
In the previous two editions of our blog we looked at some of the first activities that are likely to be encountered when developing a Safety Element out of Context (SEooC) as defined by ISO/DIS 26262-10.2:2017, “Guideline on ISO 26262”. We then moved on to consider...
by Linda Stein | Dec 13, 2017 | Automotive
In our previous blog we looked at some of the first activities that are likely to be encountered when developing a Safety Element out of Context (SEooC) as defined by ISO/DIS 26262-10.2:2017, “Guideline on ISO 26262”. In this second part of the blog we...
by Linda Stein | Nov 22, 2017 | Automotive
ISO 26262 is unusual among safety standards in that it defines a way in which an element can be developed independently from the top-level system in which it shall be integrated. This is necessary in the automotive industry with multiple tiers of suppliers delivering...
by Linda Stein | Oct 11, 2017 | Medical Devices
The forthcoming Medical Device Regulation (MDR) has gained a significant amount of attention in industry publications in recent months. The question is, how will it support design teams in ensuring they develop safe medical devices? The good news is that many of the...
by Linda Stein | Jul 27, 2017 | Automotive
In the final part of our ISO 26262 part 11 blog, we look at the additional information added to support semiconductor manufacturers assess dependent failures in integrated circuits. The DFA section of part 11 provides guidelines for the identification and analysis of...
by Linda Stein | Jul 20, 2017 | Automotive
In this second part of our ISO 26262 part 11 blog, we look at the enhanced information that supports teams with base failure rate calculation. Many points of confusion have been cleared up in section 4.6.1, including the point that there is a distinction between...
