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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

IEC 62304 and Software FMEA

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IEC 62304 and Software FMEA go well together. The software Failure Mode and Effects Analysis (FMEA) aligns with IEC 62304 by providing a systematic approach to identify and analyze potential software failure modes and their potential effects on the safety of medical device software. IEC 62304, a standard for medical device software, emphasizes risk management and requires developers to identify and mitigate potential safety risks. The Software FMEA serves as a tool to support this requirement by helping to pinpoint failure modes that could lead to hazardous situations, allowing for the implementation of appropriate risk controls. 

IEC 62304 Risk Identification and Analysis requires developers to identify potential hazards associated with the software and analyze their potential impact. The software FMEA helps in identifying specific failure modes within the software that could contribute to these hazards. 

IEC 62304 Traceability requirements emphasizes traceability between requirements, design, code, and tests. The software FMEA canbe used to document the relationship between failure modes, potential effects, and required risk controls.

IEC 62304 Risk Management requirements requires developers to manage risks related to software, including those identified through hazard analysis. The software FMEA provides a structured approach to identify, analyze, and prioritize risks, allowing for the implementation of appropriate risk controls.

IEC 62304 requires thorough documentation of the software development lifecycle, including risk assessments and mitigation strategies. The software FMEA documentation can serve as a valuable part of the risk management documentation required by IEC 62304.

In essence, the software FMEA is a tool used within the broader risk management framework of IEC 62304 to specifically address software-related risks. By using FMEA to identify potential software failures and their effects, developers can better manage risks and ensure the safety of medical device software, fulfilling the requirements of IEC 62304.

Our solutions for IEC 62304 and Software FMEA

Our approach to the software failure modes effects analysis is recommended by the IEEE 1633 Recommended Practices for Software Reliability.  

Our company has an extensive database of software failures analyzed by root cause.  From this we published the Common Defect Enumeration which covers root causes that apply to all software intensive systems including medical devices and equipment. This approach is based on the Common Defect Enumeration as well as the 6 dimension approach to identifying those root causes.  

Our products include the Requs Software FMEA which dramatically expedites the time to conduct and effective software FMEA.  This software is the only intelligent tool that can predict which of the root causes apply and their relative likelihood.  With a multifunctional team an effective software FMEA can be completed in weeks. 

We also have training on how to effectively conduct the software FMEA.  This training is available in a virtual self guided, virtual instructor guided and in person training.  Learn how to integrate the IEC 62304 and Software FMEA.

Vehicles

Reliable Vehicle Software



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Reliable vehicle software starts with the SAE JA 1002, SAE JA 1003, and the TAHB009.

Reliable Vehicle Software Expertise

Ann Marie Neufelder

Ann Marie Neufelder
SAE JA 1002 Software Reliability Program Standard 

This document contains a significant amount of research and development by our founder Ann Marie Neufelder who recently rewrote this document.

Software Reliability Program Implementation Guide JA1003

This document also contains significant amount of research and development by our founder Ann Marie Neufelder who recently rewrote this document.

SAE JA 1002, SAE JA 1003 and SAE TAHB009

In addition to having a large contribution to the SAE JA 1002 and SAE JA 1003, 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

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