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IEC 62443 Cybersecurity Certification for Medical Devices

IEC 62443 Cybersecurity Certification for Medical Devices

Block that attack!  Getting IEC 62443 Cyber Certified (Part 1)

Block that attack!  Getting IEC 62443 Cyber Certified (Part 1)

This is the next in a series of blogs and papers on the benefits of cyber certification.  Certification provides you with the opportunity to work with an experienced cyber team here at exida, and the vast knowledge of cyber experts worldwide codified in the IEC 62443 family of…

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How the PHA and LOPA are going to affect your SIS

How the PHA and LOPA are going to affect your SIS

Both Process Safety Analysis (PHA) and Layer of Protection Analysis (LOPA) occur in the early stage of the Functional Safety Lifecycle, detailed in both IEC 61511 and IEC 61508. They both serve significant roles in the whole process safety management. Yet, as a facilitator…

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Alarm System Auditing and Enforcement – The Why and the How

Alarm System Auditing and Enforcement – The Why and the How

One of the more important tasks in the alarm management lifecycle is auditing of the alarm system configuration. Auditing preserves your investment in rationalization, checks for changes that bypassed the MOC process, and helps you to maintain the integrity of the alarm system. Oh, and it also required per…

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Share the Wealth (of Functional Safety Knowledge)

Share the Wealth (of Functional Safety Knowledge)

Experience is a good teacher.  But how do you get the experience?  

Formal classroom or online training is often available for more general skills, but on-the-job training usually provides a more in-depth path to gain such experience.  After doing a job for a while, working through difficulties with colleagues,…

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Safety Alarms and Why ISA-84.91.03 is Needed

Safety Alarms and Why ISA-84.91.03 is Needed

On July 27, the US Chemical Safety Board (CSB) issued a Factual Update on their investigation into a release of water containing a toxic gas (hydrogen sulfide) and subsequent fatal injuries sustained at the Aghorn Operating Waterflood Station.  While it is typically not a good idea to comment on investigations…

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IEC 62061 Machine Safety: “It’s simply the right thing to do”

IEC 62061 Machine Safety: “It’s simply the right thing to do”

I can't begin to tell you how many of our customers share with us how lucky they have been to be incident-free at their plant.

Or, because they have not had an incident in over 10 years, it is hard to justify the cost of a Machine Hazard…

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Back to Basics: Failure Rates - λS

Back to Basics: Failure Rates - λS

The Greek symbol  λS represents safe or spurious failure rates in functional safety expressed in the unit of measurement of FITs which can be determined through FMEDAs. (FITs (λ) are failures per billion hours, expressed by 10-9 hours).

λS is the number of safe…

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IEC61511 and Failure Rates

IEC61511 and Failure Rates

Most end users I teach in our FSE100 class are not really aware of or fully, understand when we talk about failure rates.  For example, what’s a FIT mean?  For those end users more versed in this, they understand what is meant by a FIT.  Essentially a device can have…

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Block that attack!  Get Certified!

Block that attack!  Get Certified!

This is the first in a series of blogs and papers on the benefits of cyber certification.  Certification provides you with the opportunity to work with an experienced cyber team here at exida,.  It also allows you to gain access to our network of cyber experts worldwide codified…

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Know Your Human Error (Part II)

Know Your Human Error (Part II)

 

“…there is a belief amongst many engineers and managers that human error is both inevitable and unpredictable. 

However, human error is inevitable only if people are placed in situations that emphasize human weaknesses and that do not support human strengths”

Martin Anderson, IChemE Safety and Loss Prevention…

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Functional Safety Management Systems & Engineering Companies

Functional Safety Management Systems & Engineering Companies

In recent discussions with several engineering and integrators of Safety Instrumented Systems (SIS), it’s become very clear to me that the majority I have spoken to, don’t have any form of Functional Safety Management System (FSMS) in place.  This is interesting because one of the changes in the…

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OLD component data = Bad FMEDAs

OLD component data = Bad FMEDAs

When we first invented the FMEDA technique in the late 1980s the biggest problem was the component failure rate and failure mode data.  Still is.  I picked up a well-known standard for component failure rates and saw a date of 2010.  The technology world has gone through an order of…

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Back to Basics: Failure Rates - λDD

Back to Basics: Failure Rates - λDD

The Greek symbol  λDD is the detectable dangerous failure rate in functional safety expressed in the unit of measurement of FITs which can be determined through FMEDAs. (FITs (λ) are failures per billion hours, expressed by 10-9 hours).

Lambda DD

λDD is the number of…

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Risk Management in the News

Risk Management in the News

I just read a great article in the May issue of IEEE Spectrum magazine called “Managing Risk and Responsibility During a Crisis.”  The author Robert N. Charette says “If the American people desire the federal government to be their risk manager of first resort, then an open and…

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