- The document discusses a thesis defense for a universal interface for off-the-shelf safety instrumentation and controls.
- It analyzes requirements from different industries like process, nuclear, and defense and finds compatibility at the component level according to IEC 61508 standards.
- Examples are given of how individual components like transmitters and digital valve controllers that are certified to IEC 61508 can meet requirements across industries, lowering risks and costs compared to industry-specific solutions.
This seminar covers design for testability (DfT) principles based on a textbook. It is intended for those involved in manufacturing, design, or testing who want to learn how to design products for easier testing. The seminar covers topics like stress and failure analysis, variation and reliability, design analysis, development testing, manufacturing testing, software testing, and data analysis. It aims to teach participants how to design products that withstand stresses, have reliable electronics and materials, can be easily tested at different stages, and provide useful test data.
The document discusses Safety Instrumented Systems (SIS) and the Safety Life Cycle as defined by ANSI/ISA 84.00.01-2004. It outlines the steps in the Safety Life Cycle from initial Hazard and Risk Assessment to determine Safety Instrumented Functions (SIFs) and required Safety Integrity Levels (SILs), to design, installation, and ongoing maintenance of SIS including functional proof testing. The Safety Life Cycle is meant to guide safety systems through all stages from initial assessment to eventual decommissioning to minimize risk in industrial processes.
SIL = Safety Integrity Level
•Safety systems are becoming increasingly instrumented
•Depending less on human intervention and operator’s ability to respond correctly in a given situation
•Depending more on instrumentation and programmable systems
•SIL requirements are intended to ensure the reliability of such safety instrumented systems
Enumerating software security design flaws throughout the ssdlc cosac - 201...John M. Willis
A tool and methodology to enumerate security functional requirements arising in the solution space is described. A proof of concept tool for use by security architects and security engineers is described. The tool facilitates use of community-developed security requirements packages, security functional requirements, threat model taxonomy including mitigations. A risk-based decision making process is facilitated. Tool outputs used for change checklist, new test requirements, system security plan, risk decision documentation, deferred controls, and inherited controls.
QAdvis - software risk management based on IEC/ISO 62304Robert Ginsberg
This document provides an overview of risk management for medical device software as outlined in IEC 62304. It discusses:
1) IEC 62304 calls for risk management activities throughout the entire software development lifecycle. This includes identification, analysis, evaluation, control and monitoring of risks.
2) Both quantitative and qualitative techniques can be used for risk analysis, such as FMECA, FTA, HAZOP. Requirement-based and risk-based verification strategies are also expected.
3) Effective risk management relies on good software engineering practices and processes. It aims to regulate verification efforts to balance productivity and compliance.
Compliance with medical standards iec 62304, iso 14971, iec 60601, fda title ...Intland Software GmbH
Check out our latest webinar to learn more about complying with IEC 62304, ISO 14971, IEC 60601, and relevant FDA regulations (for instance, Title 21 CFR Part 11 about electronic signatures). In this webinar, we discussed the requirements set forth by these standards. We also showed our Intland's Medical IEC 62304 Template to leverage codeBeamer ALM's advanced capabilities and to facilitate compliance with these regulations.
This seminar covers design for testability (DfT) principles based on a textbook. It is intended for those involved in manufacturing, design, or testing who want to learn how to design products for easier testing. The seminar covers topics like stress and failure analysis, variation and reliability, design analysis, development testing, manufacturing testing, software testing, and data analysis. It aims to teach participants how to design products that withstand stresses, have reliable electronics and materials, can be easily tested at different stages, and provide useful test data.
The document discusses Safety Instrumented Systems (SIS) and the Safety Life Cycle as defined by ANSI/ISA 84.00.01-2004. It outlines the steps in the Safety Life Cycle from initial Hazard and Risk Assessment to determine Safety Instrumented Functions (SIFs) and required Safety Integrity Levels (SILs), to design, installation, and ongoing maintenance of SIS including functional proof testing. The Safety Life Cycle is meant to guide safety systems through all stages from initial assessment to eventual decommissioning to minimize risk in industrial processes.
SIL = Safety Integrity Level
•Safety systems are becoming increasingly instrumented
•Depending less on human intervention and operator’s ability to respond correctly in a given situation
•Depending more on instrumentation and programmable systems
•SIL requirements are intended to ensure the reliability of such safety instrumented systems
Enumerating software security design flaws throughout the ssdlc cosac - 201...John M. Willis
A tool and methodology to enumerate security functional requirements arising in the solution space is described. A proof of concept tool for use by security architects and security engineers is described. The tool facilitates use of community-developed security requirements packages, security functional requirements, threat model taxonomy including mitigations. A risk-based decision making process is facilitated. Tool outputs used for change checklist, new test requirements, system security plan, risk decision documentation, deferred controls, and inherited controls.
QAdvis - software risk management based on IEC/ISO 62304Robert Ginsberg
This document provides an overview of risk management for medical device software as outlined in IEC 62304. It discusses:
1) IEC 62304 calls for risk management activities throughout the entire software development lifecycle. This includes identification, analysis, evaluation, control and monitoring of risks.
2) Both quantitative and qualitative techniques can be used for risk analysis, such as FMECA, FTA, HAZOP. Requirement-based and risk-based verification strategies are also expected.
3) Effective risk management relies on good software engineering practices and processes. It aims to regulate verification efforts to balance productivity and compliance.
Compliance with medical standards iec 62304, iso 14971, iec 60601, fda title ...Intland Software GmbH
Check out our latest webinar to learn more about complying with IEC 62304, ISO 14971, IEC 60601, and relevant FDA regulations (for instance, Title 21 CFR Part 11 about electronic signatures). In this webinar, we discussed the requirements set forth by these standards. We also showed our Intland's Medical IEC 62304 Template to leverage codeBeamer ALM's advanced capabilities and to facilitate compliance with these regulations.
Introduction to Functional Safety and SIL CertificationISA Boston Section
This overview session will acquaint attendees with the key concepts in the IEC 61508 standard for functional safety of electrical/electronic and programmable electronic systems. An introduction is provided to safety integrity levels (SIL), the safety lifecycle and the requirements needed to achieve a functional safety certificate. Information will be provided on documentation requirements and an introduction to the basic objectives of product design for functional safety.
Embedded Systems Security: Building a More Secure DevicePriyanka Aash
The document discusses common security issues faced by embedded systems and recommendations for improving security. It identifies 12 common threats to embedded systems, such as supply chain attacks, physical access, reverse engineering, lack of secure configurations, and human errors. The document recommends building security functions into embedded systems from the start to defend against threats, understanding contract manufacturing processes, and ensuring host systems maintain control over security. It advises assessing risks and vulnerabilities based on the 12 threats and seeking external security reviews within 6 months.
This document discusses using agile software development methods for medical device software in a compliant way. It provides an overview of agile concepts like Scrum, test-driven development, and continuous integration. It also addresses how standards like IEC 62304 and risk management can help integrate agile into a regulated environment. The document recommends starting small with agile and focusing on visualization, communication, and integrating risk management activities.
Complying with New Functional Safety StandardsDesign World
The document is a presentation on complying with new functional safety standards. It discusses what functional safety is, what is happening in the functional safety market, what standards should be used for machines, and how to determine safety levels and perform calculations according to standards like ISO 13849-1 and IEC 62061. It provides an example of applying the standards to a dual channel emergency stop application and calculating the resulting safety integrity level.
What do hospital beds, blood pressure cuffs, dosimeters, and pacemakers all have in common? They are all medical devices with software that regulates their functionality in a way that contributes to Basic Safety or Essential Performance. With the FDA reporting that the rate of medical device recalls between 2002 and 2012 increased by 100% – where software design failures are the most common reason for the recalls – it’s no wonder IEC 62304 has been implemented. Its implementation, however, has medical device manufacturers asking questions about if, when and under what circumstances the standard is required.
This article explains what IEC 62304 is, when medical devices must comply with it and how IEC 62304 compliance is assessed.
The North American Electric Reliability Corporation (NERC) introduced Critical Infrastructure Protections (CIPs) as mandatory cyber security regulations, intended to protect the bulk electric grid. This compliance guide, updated according to NERC CIP version 4 (applicable as of June 25, 2012), provides an overview of the compliance requirements as well as steps to achieve NERC compliance.
To download a free Nexpose demo, click here:
http://www.rapid7.com/products/nexpose/compare-downloads.jsp
To download a free Metasploit demo, click here:
http://www.rapid7.com/products/metasploit/download.jsp
This document discusses the requirements for setting up a computer forensic lab, including physical security, fire safety, evidence storage, and necessary equipment. It recommends that the lab have access to emergency services, proper lighting and ventilation. Workstations should be shielded from electromagnetic signals and the lab built in a low-traffic area. Evidence lockers must be securely stored and monitored. The lab also requires equipment like additional hard drives, tape drives, bandwidth, and an uninterruptible power supply. Forensic workstations need high-powered processors and storage for multiple operating systems and software tools.
This document provides an overview and introduction to ISO/IEC 80001-1, which establishes a risk management framework for IT networks incorporating medical devices. It describes why the standard was created, as networks are becoming more complex and integrated. ISO/IEC 80001-1 aims to ensure the safety, effectiveness, and security of medical IT networks by defining roles and responsibilities for manufacturers, healthcare organizations, and regulators during the risk management process. It also introduces the new role of a "Medical IT-Network Risk Manager" within healthcare organizations to help manage risks and communication relating to networked medical devices.
NERC CIP Version 5 and Beyond – Compliance and the Vendor’s RoleEnergySec
Presenter: Joseph Loomis, Southwest Research Institute (SwRI)
Asset Owners face challenges as they strive towards implementing the NERC-CIP V5 requirements. Meeting the requirements often require documentation and technical knowledge of how an asset operates that can only be provided by a Vendor. Vendors, likewise, may be unclear about how the NERC-CIP requirements affect them, and are unsure about how to meet the technical requirements. In this presentation we detail the lessons learned from a recent project where SwRI worked with a Vendor to determine how the requirements apply to them and what the Vendor needs to have to help support an Asset Owner in an audit.
Integrating security into the development of an application or software is necessary to decrease its risk of susceptibility to attacks and exploits. Traditional methods of security testing were performed on a finished product. However, with the rise in the intensity and the number of attack vectors, it has become necessary for organizations to include it as a part of every phase of an SDLC.
24may 1200 valday eric anklesaria 'secure sdlc – core banking'Positive Hack Days
Secure SDLC aims to integrate security practices into the entire software development lifecycle for core banking applications. It addresses shortcomings like lack of security requirements documentation, threat modeling, secure design practices, developer security training, and security testing. Implementing a Secure SDLC helps ensure core banking applications are developed securely through practices like threat modeling, secure coding guidelines, security testing, and ongoing security reviews of applications and infrastructure. This helps protect critical banking data and systems from threats while maintaining regulatory compliance.
IEC 62304 is an international standard that defines software development lifecycle requirements for medical device software. It requires that all aspects of the software development life cycle be scrutinized to ensure patient safety when software is involved. The standard establishes software safety classes A, B, and C based on the possible risk to health from software failures. It also outlines numerous requirements for each class, including developing plans, requirements, designs, testing procedures, problem resolution processes, and more. Upon completion, all documentation should be submitted to a test lab for review to obtain certification.
William H. Linder has over 20 years of experience in IT security risk management, auditing, and compliance using frameworks such as COBIT and COSO. He has worked as an IT security risk manager and auditor for companies such as NBC Universal and Citigroup. Some of his responsibilities have included assessing risks, advising on control requirements, reviewing suppliers for compliance, and testing that controls are operating effectively. He also has experience in areas such as network security, disaster recovery, and application security assessments.
The document discusses the principles and practices of DevSecOps. It begins with an agenda that covers DevSecOps prerequisites, foundations, roles and responsibilities, and practical tips. It discusses concepts like shifting security left, continuous integration/delivery pipelines, and the importance of collaboration across roles. It provides overviews of risk management, static and dynamic testing, feature toggles, and recommends DevSecOps training and tools from Cprime. The presentation aims to help organizations adopt DevSecOps practices to improve security and deployment processes.
This document discusses engineering controls and the role of a qualified person regarding electrical hazards. It defines a qualified person according to OSHA and NFPA 70 as someone with skills/knowledge of electrical equipment/installations and safety training to recognize hazards. A qualified person must be able to distinguish live parts, determine voltages, and decide safe work methods. The NEC builds in engineering controls by limiting access to qualified personnel. Areas for consideration include access levels, resetting circuits safely, meeting code intent, contractor skills, equipment labeling, perceptions, training standards, and career development.
These are slides from local security chapters meetup, Here I tried to explain the challenges in appsec and complete framework for different life cycle of secure software development cycle
Lessons Learned For NERC CIPv5 Compliance & Configuration Change ManagementEnergySec
The NERC CIPv5 deadline is fast approaching, and it’s not too late to be prepared. Join Mark Prince, Manager Operational Technology Fossil, from Entergy, Karl Perman, VP Member Services from EnergySec and Tim Erlin, Director from Tripwire to discuss achieving and maintaining NERC CIPv5 compliance in a fossil generation plant. We’ll cover some of the challenges that Entergy has experienced in their NERC CIPv5 compliance journey. Specifically, we will discuss configuration change management and how to leverage technologies for these requirements and consider what life would be without them.
This thesis examines the increasing hostility between Saudi Arabia and Iran after 2011. It will analyze both countries' foreign and domestic policies through the lens of neoclassical realism. The thesis begins by providing background on Saudi Arabia, Iran, and the importance of Bahrain in their rivalry. It then conducts a comparative analysis of the similarities and differences between Saudi Arabia and Iran across several factors that influence their relationship, such as support for proxies, military spending, alliances, and religion. The conclusion synthesizes how these various internal and external factors have intensified Saudi-Iranian tensions in recent years. The research aims to comprehensively explain the root causes of the current rivalry and contribute new insights to academic debates on this important geopolitical
Pakistan has pursued different foreign policy approaches throughout its history based on changing geopolitical circumstances. Initially, it explored friendly relations with all countries after independence. It then aligned with Western countries during the Cold War, joining organizations like SEATO and CENTO. From the 1960s, Pakistan transitioned to bilateral relations and non-alignment. It supported Afghanistan during the Soviet invasion and rebuilt ties with the US. Following the Cold War, Pakistan pursued a nuclear program and dealt with insurgencies while maintaining strategic relations with China and others. Since 9/11, Pakistan has played an active but difficult role in counterterrorism efforts while seeking to promote regional peace and stability.
Introduction to Functional Safety and SIL CertificationISA Boston Section
This overview session will acquaint attendees with the key concepts in the IEC 61508 standard for functional safety of electrical/electronic and programmable electronic systems. An introduction is provided to safety integrity levels (SIL), the safety lifecycle and the requirements needed to achieve a functional safety certificate. Information will be provided on documentation requirements and an introduction to the basic objectives of product design for functional safety.
Embedded Systems Security: Building a More Secure DevicePriyanka Aash
The document discusses common security issues faced by embedded systems and recommendations for improving security. It identifies 12 common threats to embedded systems, such as supply chain attacks, physical access, reverse engineering, lack of secure configurations, and human errors. The document recommends building security functions into embedded systems from the start to defend against threats, understanding contract manufacturing processes, and ensuring host systems maintain control over security. It advises assessing risks and vulnerabilities based on the 12 threats and seeking external security reviews within 6 months.
This document discusses using agile software development methods for medical device software in a compliant way. It provides an overview of agile concepts like Scrum, test-driven development, and continuous integration. It also addresses how standards like IEC 62304 and risk management can help integrate agile into a regulated environment. The document recommends starting small with agile and focusing on visualization, communication, and integrating risk management activities.
Complying with New Functional Safety StandardsDesign World
The document is a presentation on complying with new functional safety standards. It discusses what functional safety is, what is happening in the functional safety market, what standards should be used for machines, and how to determine safety levels and perform calculations according to standards like ISO 13849-1 and IEC 62061. It provides an example of applying the standards to a dual channel emergency stop application and calculating the resulting safety integrity level.
What do hospital beds, blood pressure cuffs, dosimeters, and pacemakers all have in common? They are all medical devices with software that regulates their functionality in a way that contributes to Basic Safety or Essential Performance. With the FDA reporting that the rate of medical device recalls between 2002 and 2012 increased by 100% – where software design failures are the most common reason for the recalls – it’s no wonder IEC 62304 has been implemented. Its implementation, however, has medical device manufacturers asking questions about if, when and under what circumstances the standard is required.
This article explains what IEC 62304 is, when medical devices must comply with it and how IEC 62304 compliance is assessed.
The North American Electric Reliability Corporation (NERC) introduced Critical Infrastructure Protections (CIPs) as mandatory cyber security regulations, intended to protect the bulk electric grid. This compliance guide, updated according to NERC CIP version 4 (applicable as of June 25, 2012), provides an overview of the compliance requirements as well as steps to achieve NERC compliance.
To download a free Nexpose demo, click here:
http://www.rapid7.com/products/nexpose/compare-downloads.jsp
To download a free Metasploit demo, click here:
http://www.rapid7.com/products/metasploit/download.jsp
This document discusses the requirements for setting up a computer forensic lab, including physical security, fire safety, evidence storage, and necessary equipment. It recommends that the lab have access to emergency services, proper lighting and ventilation. Workstations should be shielded from electromagnetic signals and the lab built in a low-traffic area. Evidence lockers must be securely stored and monitored. The lab also requires equipment like additional hard drives, tape drives, bandwidth, and an uninterruptible power supply. Forensic workstations need high-powered processors and storage for multiple operating systems and software tools.
This document provides an overview and introduction to ISO/IEC 80001-1, which establishes a risk management framework for IT networks incorporating medical devices. It describes why the standard was created, as networks are becoming more complex and integrated. ISO/IEC 80001-1 aims to ensure the safety, effectiveness, and security of medical IT networks by defining roles and responsibilities for manufacturers, healthcare organizations, and regulators during the risk management process. It also introduces the new role of a "Medical IT-Network Risk Manager" within healthcare organizations to help manage risks and communication relating to networked medical devices.
NERC CIP Version 5 and Beyond – Compliance and the Vendor’s RoleEnergySec
Presenter: Joseph Loomis, Southwest Research Institute (SwRI)
Asset Owners face challenges as they strive towards implementing the NERC-CIP V5 requirements. Meeting the requirements often require documentation and technical knowledge of how an asset operates that can only be provided by a Vendor. Vendors, likewise, may be unclear about how the NERC-CIP requirements affect them, and are unsure about how to meet the technical requirements. In this presentation we detail the lessons learned from a recent project where SwRI worked with a Vendor to determine how the requirements apply to them and what the Vendor needs to have to help support an Asset Owner in an audit.
Integrating security into the development of an application or software is necessary to decrease its risk of susceptibility to attacks and exploits. Traditional methods of security testing were performed on a finished product. However, with the rise in the intensity and the number of attack vectors, it has become necessary for organizations to include it as a part of every phase of an SDLC.
24may 1200 valday eric anklesaria 'secure sdlc – core banking'Positive Hack Days
Secure SDLC aims to integrate security practices into the entire software development lifecycle for core banking applications. It addresses shortcomings like lack of security requirements documentation, threat modeling, secure design practices, developer security training, and security testing. Implementing a Secure SDLC helps ensure core banking applications are developed securely through practices like threat modeling, secure coding guidelines, security testing, and ongoing security reviews of applications and infrastructure. This helps protect critical banking data and systems from threats while maintaining regulatory compliance.
IEC 62304 is an international standard that defines software development lifecycle requirements for medical device software. It requires that all aspects of the software development life cycle be scrutinized to ensure patient safety when software is involved. The standard establishes software safety classes A, B, and C based on the possible risk to health from software failures. It also outlines numerous requirements for each class, including developing plans, requirements, designs, testing procedures, problem resolution processes, and more. Upon completion, all documentation should be submitted to a test lab for review to obtain certification.
William H. Linder has over 20 years of experience in IT security risk management, auditing, and compliance using frameworks such as COBIT and COSO. He has worked as an IT security risk manager and auditor for companies such as NBC Universal and Citigroup. Some of his responsibilities have included assessing risks, advising on control requirements, reviewing suppliers for compliance, and testing that controls are operating effectively. He also has experience in areas such as network security, disaster recovery, and application security assessments.
The document discusses the principles and practices of DevSecOps. It begins with an agenda that covers DevSecOps prerequisites, foundations, roles and responsibilities, and practical tips. It discusses concepts like shifting security left, continuous integration/delivery pipelines, and the importance of collaboration across roles. It provides overviews of risk management, static and dynamic testing, feature toggles, and recommends DevSecOps training and tools from Cprime. The presentation aims to help organizations adopt DevSecOps practices to improve security and deployment processes.
This document discusses engineering controls and the role of a qualified person regarding electrical hazards. It defines a qualified person according to OSHA and NFPA 70 as someone with skills/knowledge of electrical equipment/installations and safety training to recognize hazards. A qualified person must be able to distinguish live parts, determine voltages, and decide safe work methods. The NEC builds in engineering controls by limiting access to qualified personnel. Areas for consideration include access levels, resetting circuits safely, meeting code intent, contractor skills, equipment labeling, perceptions, training standards, and career development.
These are slides from local security chapters meetup, Here I tried to explain the challenges in appsec and complete framework for different life cycle of secure software development cycle
Lessons Learned For NERC CIPv5 Compliance & Configuration Change ManagementEnergySec
The NERC CIPv5 deadline is fast approaching, and it’s not too late to be prepared. Join Mark Prince, Manager Operational Technology Fossil, from Entergy, Karl Perman, VP Member Services from EnergySec and Tim Erlin, Director from Tripwire to discuss achieving and maintaining NERC CIPv5 compliance in a fossil generation plant. We’ll cover some of the challenges that Entergy has experienced in their NERC CIPv5 compliance journey. Specifically, we will discuss configuration change management and how to leverage technologies for these requirements and consider what life would be without them.
This thesis examines the increasing hostility between Saudi Arabia and Iran after 2011. It will analyze both countries' foreign and domestic policies through the lens of neoclassical realism. The thesis begins by providing background on Saudi Arabia, Iran, and the importance of Bahrain in their rivalry. It then conducts a comparative analysis of the similarities and differences between Saudi Arabia and Iran across several factors that influence their relationship, such as support for proxies, military spending, alliances, and religion. The conclusion synthesizes how these various internal and external factors have intensified Saudi-Iranian tensions in recent years. The research aims to comprehensively explain the root causes of the current rivalry and contribute new insights to academic debates on this important geopolitical
Pakistan has pursued different foreign policy approaches throughout its history based on changing geopolitical circumstances. Initially, it explored friendly relations with all countries after independence. It then aligned with Western countries during the Cold War, joining organizations like SEATO and CENTO. From the 1960s, Pakistan transitioned to bilateral relations and non-alignment. It supported Afghanistan during the Soviet invasion and rebuilt ties with the US. Following the Cold War, Pakistan pursued a nuclear program and dealt with insurgencies while maintaining strategic relations with China and others. Since 9/11, Pakistan has played an active but difficult role in counterterrorism efforts while seeking to promote regional peace and stability.
Thesis Defence for Doctor of Information ScienceYuma Inoue
This document summarizes Yuma Inoue's doctoral thesis defense presentation on permutation set manipulation based on decision diagrams. The presentation covered topics including reversible circuit debugging, cycle-type partitioning of permutations, enumeration of topological orders using rotation-based πDDs, and other applications of permutation decision diagrams (πDDs) and related data structures. It provided examples and outlined Inoue's contributions to algorithms for manipulating and analyzing permutation sets in an efficient manner using decision diagrams.
This document provides tips for writing a thesis. It discusses starting the writing process early by choosing a title and outline. The outline should summarize the argument in one sentence for each chapter. Material should be collected in a binder as it is researched. Examiners will want to understand the thesis quickly, so the abstract, conclusions, and contents should clearly convey the purpose and findings. Getting feedback from others helps improve the thesis before examination. Regularly interacting with potential examiners also helps them understand and appreciate the research.
Powerpoint presentation M.A. Thesis DefenceCatie Chase
This document summarizes a research study that examined self-determination in post-secondary students with learning disabilities based on whether they were identified as having an LD in primary/secondary school or as an adult. The study found no statistically significant differences in self-determination, as measured by a self-determination scale, between the two groups of students. The discussion considers limitations of the study related to measurement, sample size, and sampling biases. Implications are discussed for further examining the relationship between time of LD identification and self-determination with more reliable measures and larger sample sizes.
This document outlines the dissertation of Naomi M. Mangatu titled "Beyond the Glass Ceiling: A Phenomenological Study of Women Managers in the Kenyan Banking Industry." The study explores the lived experiences of 24 women managers in Kenyan banks to understand factors contributing to or hindering their advancement to CEO positions. It uses a qualitative phenomenological research method and the van Kaam 7-step process for data analysis. The findings reveal that while women have made progress in their careers, few break through the glass ceiling to attain top leadership roles in Kenyan banks due to social pressures, cultural norms, and expectations that suppress women's advancement.
The document summarizes research being conducted on incorporating pile setup into pile design using Load and Resistance Factor Design (LRFD). The research aims to identify conditions where pile setup may be used, determine the reliability of pile setup prediction methods, and establish resistance factors. Field data on pile setup is presented from a bridge project in Louisiana. Methods for predicting pile setup are described, including empirical equations and static capacity methods using Cone Penetration Test data. Software tools for pile capacity analysis incorporating pile setup are identified.
This study demonstrated a novel natural transformation mechanism in Actinobacillus actinomycetemcomitans (A.a.) that is independent of uptake signal sequences and the Tfox gene. The study showed that A.a. could be transformed with genomic and plasmid DNA present in microvesicles secreted into the growth medium of donor cells. This transformation occurred both in the presence and absence of components normally required for natural transformation in A.a. The results suggest outer membrane adhesion and fusion of donor microvesicles with recipient cells allows DNA delivery and homologous recombination. This novel mechanism could provide an easier method for genetically transforming A.a. compared to conventional techniques.
SIL Awareness | Introduction to Safety Life-Cycle | IEC - 61508 & IEC- 61511 ...Gaurav Singh Rajput
This document provides an overview of the safety lifecycle (SLC) process as defined in IEC 61508 and IEC 61511 standards. The SLC consists of three main phases - analysis, realization, and operation. The analysis phase involves identifying process hazards, estimating risks, and determining safety instrumented functions (SIFs) required to reduce risk to a tolerable level. Key activities in the analysis phase include hazard identification techniques like HAZOP and assessing the likelihood and consequences of hazardous events. The realization phase focuses on designing, implementing, and testing the safety instrumented systems (SIS) to achieve the required SIFs. The operation phase centers around maintaining and managing the SIS to ensure ongoing functional safety
Presentation during the Inaugural IEEE Smart Grid Cybersecurity Workshop (http://sites.ieee.org/ucw/). The talk was in Session 1: Overview of the Security Situation/Risk Managment. The presentation identifies 5 hurdles that need to be addressed before we can secure the grid. Other presentations from the event are available for download at the IEEE Smart Grid Resource Center http://resourcecenter.smartgrid.ieee.org/category/conferences/-/society-featured-articles/subcategory/913483
This document discusses software quality management standards. It defines software quality and explains that standards aim to manage quality and development processes. The document outlines three major standards activities: software quality assurance which establishes organizational procedures; software quality plans which select applicable procedures for a project; and software quality control which ensures procedures are followed. It provides examples of standards organizations and types of standards including quality assurance, project management, system engineering, safety, and product standards. The document also notes some problems with software quality standards.
CI SCS provides certified fault tolerant safety control systems for critical industrial applications. They have over 35 years of experience in safety system design, certification, and support. Their safety control systems are certified to international standards like IEC 61508 and 61511 and provide reliable, cost-effective solutions for applications in manufacturing, oil and gas, aerospace, and utilities using programmable controllers from vendors like GE and Siemens. CI SCS designs, builds, and certifies complete safety solutions including hardware, software, system design, and certification.
This document discusses approaches for managing risk in innovation projects through reliability engineering. It describes three methods: theoretical using standards and simulations, pragmatic with accelerated testing, and analytical using probability of failure calculations. The theoretical approach involves scoping subsystems and identifying reliability metrics from norms. Calculations include MTBF and FIT rates. Simulations validate designs through FEA, software, and system modeling. Pragmatic testing uses highly accelerated life testing to discover weaknesses early in design phases. The goal is to improve reliability and reduce costs from late-stage changes.
Risk management and business protection with Coding Standardization & Static ...Itris Automation Square
This document discusses the importance of risk management and software quality control for system integrators. It provides examples of costly failures from bugs in software that controlled spacecraft, medical devices, and networks. These examples demonstrate the need for coding standards, static analysis tools, and defensive programming techniques to detect and prevent bugs. The document advises system integrators to implement standards, verify code quality, educate customers on standards, and use static analysis tools to protect themselves from potential liability issues from software defects.
A Big Picture of IEC 62443 - Cybersecurity Webinar (2) 2020Jiunn-Jer Sun
• Why An Industrial Cybersecurity Standard
• What Is IEC 62443 About
• How It Impacts On You - The Security Lifecycle
• IEC 62443 Certificates
• Reference: Some Ongoing Projects
• Summary
Embedded software engineering has become a much bigger and more complex domain than we could have imagined. As devices are expected to communicate with other devices and embedded subsystems, a much larger surface area has emerged for defects that threaten the safety, security, and reliability of the software. For example, the connected car not only introduces software safety and security concerns within the car as a system, interactions with environmental components, such as communicating with 'smart traffic lights' and vehicle-to-vehicle communication, potentially expose additional risk. Additionally, as car makers develop and merge functionality into 'the autopilot' mode, driver-assist technologies have become safety-critical technologies.
Embedded software organizations have always taken a 'shift-left' approach to software quality, rigorously applying defect prevention techniques early in the lifecycle. The demand for IoT requires a new testing paradigm that more closely resembles the challenges that Enterprise IT have faced for decades. As enterprise IT struggles to 'shift-left', embedded systems are struggling to 'shift-right' by testing more componentized and distributed architectures.
2010 SDLC Lifeline Mater Deck for knowledge sharinggangcheng19721
This document provides an overview of GE's SDLC (software development lifecycle) process. It discusses key aspects of the SDLC including the V-model process, software safety classification, requirements development, traceability, and mapping requirements to architecture. The presentation aims to help teams implement the SDLC effectively and consistently to manage software risks and ensure regulatory compliance.
When created early in the product development lifecycle, a trace matrix can do more than just help you gain FDA approval for your device. Unfortunately, many companies create the matrix sporadically during a project, mainly right before regulatory submission—too late to capture the benefits a well-maintained matrix can deliver.
During this recorded webinar, guest speaker Steve Rakitin, President of Software Quality Consulting, discussed five of the benefits gained by maintaining a matrix throughout the project. A software engineer with more than 20 years of experience in the medical device industry, Steve explains how a trace matrix can help you:
- Plan and estimate testing and validation needs
- Ensure all requirements are implemented
- Verify that all requirements have been tested
- Manage change throughout product development
- Provide evidence that hazard mitigations are implemented and validated
Beyond FDA Compliance Webinar: 5 Hidden Benefits of Your Traceability MatrixSeapine Software
This document discusses the regulatory requirements for software traceability and the benefits of using a requirements trace matrix (RTM). It notes that traceability is required by FDA guidance to link requirements with design, implementation, testing and risk mitigation. An RTM provides benefits such as ensuring all requirements are implemented and tested, managing changes, and demonstrating that hazards are mitigated. The document provides an example of how an RTM can be used and validated as a software tool.
The document discusses IEC 62443, a series of standards that define cybersecurity requirements and best practices for industrial automation and control systems (IACS). The standards aim to assess security performance and bridge the gap between operational technology (OT) and information technology (IT). They establish seven foundational requirements for access control, user control, data integrity, confidentiality, restricted data flow, timely event response, and resource availability. The standards also define a maturity model to assess organizations' cybersecurity practices and controls based on five security levels that range from initial to improved practices.
Semiconductor test engineering is the process of screening semiconductor devices to remove defective parts before shipment. This is done through testing to detect defects rather than prove the devices work as intended. The goal is to ensure high quality by catching manufacturing defects. If untested devices were shipped, many faulty ones could reach customers. Test engineering develops programs and hardware to efficiently test large volumes of devices in parallel while subjecting them to stress conditions to reveal marginal defects. It is important for achieving high yield and low cost.
The document discusses functional safety activities based on IEC 61508 and IEC 61511 standards. It covers two parts: process control and safety, and personnel safety and access control. For process control and safety, it describes the IEC standards, the safety integrity level (SIL) concept, and the IEC 61508 safety lifecycle which includes analysis, realization, and commissioning. It also provides examples of how risk analysis links to safety instrumented functions and SIL levels. The document notes differences between IEC 61508 and IEC 61511, with the latter being more specific to process industries.
The document summarizes a presentation on applying the IEC 61508 functional safety standard at the component level for nuclear power plants. It discusses how IEC 61508 is used differently between the process industry and commercial nuclear industry. While there are some differences at the system level between the industries, the standard can be applied effectively at the component level for both due to minimal differences in reliability and correctness requirements. Certifying components to IEC 61508 could allow their utilization for nuclear safety applications through a commercial grade dedication process.
1) IEC 61508 is an international standard for functional safety of electrical, electronic, and programmable electronic safety-related systems. It standardizes safety requirements and assessment methodologies that can be applied across industries.
2) The nuclear industry could benefit from using components certified to IEC 61508, as it offers advantages in technical rigor and economics. Components certified as SIL 2 or higher have undergone reliability and correctness assessments that align with nuclear industry needs.
3) IEC 61508 certification of individual components, like sensors, controllers, and actuators, remains compatible with existing nuclear safety system requirements and could facilitate commercial-grade dedication or suitability evaluations for digital equipment.
Ruud Cox - Testing in a Medical Device Context - EuroSTAR 2012TEST Huddle
EuroSTAR Software Testing Conference 2012 presentation on Testing in a Medical Device Context by Ruud Cox. See more at: http://conference.eurostarsoftwaretesting.com/past-presentations/
The document discusses robustness testing of systems in critical infrastructure industries using the Achilles Test Platform. The platform allows manufacturers to thoroughly test devices for cyber vulnerabilities before releasing products to market. This helps ensure devices are secure and reliable, avoids costly issues in the field, speeds time to market, and prepares devices for industry certification standards.
3. Introduction
• High risk industries require reliable and
correct safety systems
• Safety system reliability and correctness
must be provable
• Typical manufacturers may not achieve
the required levels of reliability and
correctness, or just can’t prove it
4. Introduction
• Each high risk industry has its own set of
laws, requirements, and guidelines
• Standardization could benefit
manufacturers and industries
• IEC 61508 is intended to be a non-industry
specific functional safety standard
5. Introduction
IEC 61508 (Non-industry specific)
• Part 1- general requirements
• Part 2- system and hardware requirements
• Part 3- software requirements
• Part 4- definitions and abbreviations
• Part 5- examples of determination of SILs
• Part 6- guidelines for Parts 2 and 3
• Part 7- overview of techniques and measures
9. Multi-Industry Survey
• Process Industry Includes:
• Chemicals
• Oil Refineries
• Oil and Gas Production
• Pulp and Paper
• Non-nuclear Power Production
10. Multi-Industry Survey
• Process Industry
• Relatively low level of regulation
• Early adoption of IEC 61508
• Large customer base for manufacturers
• SIL 4 applications are unlikely
11. Multi-Industry Survey
Commercial Nuclear Power Generation
• International Atomic Energy Agency (IAEA)
• IEEE Standards
• United States
• Asian Pacific Countries
• IEC Standards
• European Union
12. Multi-Industry Survey
Commercial Nuclear Power Generation
• Relatively high regulation
• Currently only limited adoption and utilization of IEC
61508
• Struggling with the incorporation of digital equipment
into safety systems
• Small customer base for manufacturers, and therefore,
has the greatest potential to benefit from IEC 61508
13. Multi-Industry Survey
United States Department of Defense
Includes: Army, Navy, and Airforce
• Wide variety of applications and requirements
• No broad adoption of IEC 61508
• A potentially large customer base for
manufacturer
14. Compare and Contrast
Categories for comparison:
• Classification of systems and components
• Defending against random failures
• Preventing systematic faults
• Suitability evaluations of “off-the-shelf”
equipment
15. Compare and Contrast
Classification of systems and components
• Deterministic vs Probabilistic
• Probability accounts for variability of risk
• Qualitative vs Quantitative
• Levels of Rigor
• Standardizes efforts to establish design integrity
• Each industry is different but all could map to
the SILs
16. Compare and Contrast
Defending against random hardware failures
• Single failure criterion vs probabilistic
reliability analysis
• Different at the system level but
compatible at the component level
17. Compare and Contrast
Preventing systematic faults
• Lifecycle processes and designing
techniques
• Built-in safety features
• Design analysis and verification & validation
• Hazard analysis
18. Compare and Contrast
Preventing systematic faults
• Common cause failure prevention
• Diversity and defense in-depth (D3) vs
general guidance
• Environmental qualification
• Some applications exceed typical qualification
levels
19. Compare and Contrast
Suitability evaluations of “off-the-shelf”
equipment
• Functional suitability
• Review design processes
• Operating history
20. Compare and Contrast
Category
Significance of
Differences at the
System Level
Significance of
Differences at the
Component Level
Classification Schemes
Probabilistic vs Deterministic
Level of Rigor
High
High
Low
Low
Defense against Random Hardware
Failures
High Low
Preventing Systematic Faults
Lifecycle Processes
Built-in Design Safety Features
Design Analysis, Verification, and
Validation
Hazard Analysis
Common Cause Failure Prevention
Environmental Qualification
Low
Low
Low
Low
High
High
Low
Low
Low
Low
Low
High
Suitability Evaluations of “Off-the-Shelf”
Equipment
Low Low
21. Universal Interface
• IEC 61508 is a non-industry specific,
technical requirements interface
• Compatibility of technical requirements at
the component level
• Third-party certification is a positive
indicator
22. Universal Interface
Example: Moore Industries STZ Transmitter
• SIL 3 Capable
• Defense against random failures
• Preventing systematic faults
• Lifecycle processes and designing techniques
• Built-in safety features
• Design analysis and verification & validation
• Hazard analysis
• Common cause failure prevention
• Environmental qualification (may require extra effort)
23. Universal Interface
Example: Fisher Controls DVC6200 SIS Digital
Valve Controller
• SIL 3 Capable
• Defense against random failures
• Preventing systematic faults
• Lifecycle processes and designing techniques
• Built-in safety features
• Design analysis and verification & validation
• Hazard analysis
• Common cause failure prevention
• Environmental qualification (may require extra effort)
24. Conclusion
• A universal interface at the component
level is feasible and beneficial
• IEC 61508 should be that interface
• Third-party certification removes
significant risk to industries
Random hardware failures and systematic faults must be prevented and defended against to an acceptable extent so safety functions are ensured to be able to be performed when needed.
Equipment and associated documentation must stand up against severe scrutiny.
It can’t be assumed that a typical commercial manufacturer’s equipment designs and associated design activities will be adequate to allow for success in these high risk applications.
A 7 part set of non-industry specific safety standards.
Defines a full range of lifecycle activities
Part 2 addresses systematic faults and random failures of hardware
Part 3 addresses systematic faults of software
Both Parts 2 & 3 addresses the use of the Prior-Use basis of proof
A 7 part set of non-industry specific safety standards.
Defines a full range of lifecycle activities
Part 2 addresses systematic faults and random failures of hardware
Part 3 addresses systematic faults of software
Both Parts 2 & 3 addresses the use of the Prior-Use basis of proof
The IEC 61508 set of standards exists to fulfill this role, but it is not yet universally embraced. After that occurs, various industries, from nuclear power generation to oil & gas production, will benefit from the existence of a wider range of equipment that has been designed to perform in these critical roles and that also includes the evidence necessary to prove its integrity. The manufacturers will then be able to enjoy the benefit of having a larger customer base interested in their products.
The use of IEC 61508, as a universal interface, will also help industries avoid significant amounts of uncertainty when selecting commercial off-the-shelf equipment.
There are other industries, such as food and drugs production and aviation/aerospace, that involve high risk application for I&C equipment, but one of my early lessons from this thesis work was that I needed to make this task focused. I couldn’t cover everything and it was ok to leave some scope for future work.
No national regulator specifically designated to supervise any of these industries specifically, such as the NRC, FAA, or FDA.
In order to keep levels of regulation relatively low, these industries were motived to self initiate safety standards.
This is a highly abstracted view. There are several exceptions. Compliance with IAEA varies significantly. Some countries such as Russia, don’t utilize the international standards within their regulatory framework.
US, France, and UK surveyed
IEC 61508 is not well embraced even in the IEC nuclear standards.
This is the criteria that was used to compare the different industries.
Nuclear is mainly deterministic
Process and DOD are probabilistic
Nuclear uses single failure criterion
Process and DOD use probabilistic reliability analysis
All of these topics were found to be similar among the industries surveyed
Lifecycles facilitate a very methodical process which causes the design team to focus on making sure that they fully accomplished what they set out to do.
Built-in safety features: self-diagnostics
Design analysis and V&V: generally required but the details are left open ended
Hazard analysis: identify potential hazards and mitigate them
These topics had significant differences and were the most incompatible.
Common cause failure is difficult at the system level but not bad at the component level.
Environmental qualification may require additional attention when generic requirements are exceeded
A universal interface is feasible at the component level
Some aspects may continue to require extra effort
Third party certification to SIL 2 or above indicates that a manufacturer is accustom to being audited and scrutinized
SIL 1 is excluded because at that level, some uncertainty about the design and manufacturing processes remains due to the greater potential for the “proven in use” basis to be utilized. To achieve SIL 2 or higher it can be more reasonably assumed that the original development activities included intentional efforts to seek compliance with IEC 61508.
171 Safe FITs, 166 Dangerous Detected FITs, 85 Dangerous Undetected FITs
Self-diagnostics, Fault detection, Configurable safe failed state,
Designed to detect faults in: Software control flow, Software data flow
FMEDA
CE Mark, Explosive atmosphere enclosure