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Space

NASA Software Safety Handbook

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Founder

Ann Marie Neufelder

Ann Marie Neufelder

Ann Marie Neufelder developed the NASA software FMEA and software FTA webinars as well as NASA’s Software Analyses training class.  

NASA Software Safety Handbook

NASA Software Safety Handbook 8719-13Ann Marie has also researched and categorized every software failure in the space industry by root cause – faulty data and faulty error handling are so far the most common.  Faulty timing, faulty sequencing, faulty processing and faulty state management are other root causes.

NASA Software Safety Handbook 8719.13 and NASA Software Assurance and Software Safety Standard 8739.8a are the basis for the software FMEA and software safety assessments we employ for space systems.  We also are experts on IEEE 1633 which is referenced by NASA 8739.8a.

Ann Marie and her team have successfully implemented the safety-related practices in the NASA Software Safety Handbook 8719.13. In fact, our benchmarking study shows that several of these practices correlate to reduced software defect density and increased software reliability in addition to affecting safety.

Our benchmarking shows that the criteria discussed in NASA Software Assurance and Software Safety Standard 8739.8a is also correlated to reduced software defect density and increased reliability in addition to affecting software safety. These criteria are a standard consideration in the software FMEA services we provide. Ann Marie Neufelder has analyzed the software-related failure modes and root causes for the NASA software-related mishaps and incorporates each of them into the software FMEA analysis.  Ann Marie has also analyzed the process-related failure modes for the NASA software-related mishaps.  

Every failure event has at least one functional root cause and one process root cause.  The process root causes are what went wrong in software development that allowed the defect in the software to escape.  This database of events is how we can assess the likelihood of software failure modes in the software failure modes effects analysis.

Our team has decades of experience ensuring mission-ready space systems.

Medical Devices

Software Reliability for Medical Devices

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Software reliability for medical devices and equipment is a large part of what we do.  FDA-regulated medical equipment and devices have particular challenges with regards to reliable and software failure modes effects analysis. Those challenges require an experienced analyst who knows the industry and the products.  

Software reliability services, training and tools for medical devices and equipment

Conduct and facilitate software and firmware design failure modes effects analysis for FDA regulated medical devices and equipment

Conduct a software or firmware defect root cause analysis.  This ensures that development, review and test and effort is tailored on the failure modes that are the most prevalent

Assess the software and firmware reliability for medical devices and equipment using industry-accepted models 

Identify feasible alternatives for improving the software reliability for medical devices and equipment  

Review the processes for developing software and firmware to ensure that they are optimized for reliability

Conduct and facilitate software and firmware fault tree analysis. The software fault tree analysis is a top-down approach that can drive requirements as well as the software design FMEA.

Provide feasible and proven recommendations for improving the processes and the software while also improving on-time delivery

Estimate software and firmware reliability growth using recognized and established models

Provide expert guidance with regards to IEC 62304, ISO 14971, CFR820 and EU MDR 

Vehicles

Reliable Vehicle Software

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Expertise

Ann Marie Neufelder

Ann Marie Neufelder

SAE JA 1002 Software Reliability Program Standard contains a significant amount of research and development by our founder Ann Marie Neufelder.  The software reliability predictions discussed in the SAE JA 1002 document were invented by our founder. 

SAE JA 1002

SAE JA 1002

In addition to having a large contribution to the SAE JA 1002, Ann Marie was also a key contributor to the SAE TAHB 009 Reliability Program Handbook and wrote several of the sections regarding software reliability and failure modes analysis. Ann Marie has experience with software FMEA and software reliability predictions with a variety of vehicles including armored and agricultural as well as driverless agricultural.

Reliable vehicle software starts with a software reliability program as per SAE JA 1002 and TAHB 009 Reliability Program Handbook. A software failure modes effects analysis is becoming a must-have in this industry.  Ann Marie’s publication “Effective Application of Software Failure Modes Effects Analysis” is a much needed update to the nearly 20 year old SAE ARP 5580 Recommended Failure Modes and Effects Practices for Non-Automobile Applications.  Firstly the SAE ARP 5580 document is applicable to automobiles for the simple reason that software failure modes, root causes, and design FMEAs aren’t application industry-specific.   Secondly, the SAE ARP5580 has insufficient examples.  Thirdly, it is outdated with regards to the failure modes and root causes and it advises a “black box” approach which has been found to be mostly ineffective.  It also lacks much-needed tailoring guidance.  Ann Marie’s updated document employs the same approach and infrastructure as ARP 5580 but with much-needed tailoring and failure modes and root causes that reflect those commonly found in the industry.

Ann Marie will conduct any of these analyses to ensure reliable vehicle software:

  1. Assess the software and firmware reliability of the vehicle using her industry accepted models
  2. Conduct and facilitate the software and firmware design FMEA for the vehicle
  3. Conduct and facilitate a software and firmware fault tree analysis of the vehicle
  4. Conduct a software safety assessment of the vehicle
  5. Assess the reliability growth of the software and firmware in the vehicle to determine its release readiness
  6. Develop reliability test suites for the software and firmware
  7. Identify the most common failure modes and root causes to ensure cost-effective defect reduction and software design FMEAs
  8. Identify the development practices in the SAE JA 1002 that are applicable and feasible for your program

 

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