Systems engineering is an interdisciplinary approach that focuses on defining customer needs, documenting requirements, and enabling the realization of successful systems. It considers both business and technical needs across the entire life cycle from concept to disposal. Requirements management is the foundation of systems engineering. Organizations can improve processes and reduce risks through structured approaches like the Systems Engineering V-Model and maturity models like CMMI that provide standard processes and best practices. Verification and validation are used to ensure a system meets its requirements through methods like testing, analysis and demonstration.
FDA Design Controls: What Medical Device Makers Need to KnowGreenlight Guru
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FDA Design Control regulations defined in 21 CFR 820.30 have been in place for 20 years now, yet year after year they continue to be one of the top issues cited during inspections.
This does not, and should not, be the case for your medical device company.
Join us for this free, two-part webinar series presented by two of the world's leading experts on the topic to learn how to implement a design control process that will not only ensure compliance but will actually benefit your product development efforts.
(You can view both webinars here: http://www.greenlight.guru/webinar/medical-device-design-controls)
In Part 1, you'll learn about Intended Use, User Needs, Design Inputs, Design Reviews, Design History File (DHF) and Risk Management.
Specifically:
-The importance of getting your intended use right up front
-The difference between a user need and a design input that's verifiable
-What stakeholders need to be involved in the process and why
-When and how many design reviews you should hold
-Why FMEA alone is NOT risk management and how to integrate risk into the design and development process
In Part 2, you'll learn about Design Outputs, Device Master Record (DMR), Design Verification and Validation (V&V), Design Transfer and Regulatory Submissions.
Specifically:
-Why your design outputs need to be more than a drawing and their relationship to your DMR
-How usability and human factors fits into the overall product development
-Making sure you build the correct device and build it correctly with design V&V
-Common mistakes people make during design transfer to production and how to avoid them
-When you can and should make your regulatory submission
The Top 10 Most Significant Changes Introduced by the New EU MDR (and how to ...Greenlight Guru
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As most of you have likely heard, the EU's new Medical Device Regulations (MDR) went into effect earlier this year replacing the old MDD and setting in motion a three-year countdown for manufacturers to comply to continue selling in the European market.
You also likely have a lot of questions about what do these changes mean, how can you begin preparing, how will they affect your company, what are their greatest implications, etc.?
Specifically, this presentation covers:
-How much will the new Medical Device Regulation cost?
-Why did it need to happen and what is the new structure?
-What additional activities does a manufacturer have to carry out?
-What are the top 10 most significant changes?
-What is EUDAMED and how has its role changed?
-And much more...
Watch the presentation here: https://www.greenlight.guru/webinar/eu-mdr-most-significant-changes
Medical devices â Quality management
systems â Requirements for regulatory
Purposes. ISO is an organization that develops Standards for use
worldwide.
ISO 13485 helps companies do their share in protecting
consumers and users of medical devices.
ISO 13485 Outlines criteria for a good Quality
Management System (QMS).
QMS criteria are good business practices ...
for example:
⢠Set Quality goals
⢠Ensure that regulations and other requirements are
understood and met
⢠Train employees
⢠Control your production processes
⢠Purchase from suppliers that can provide products that
meet your requirements
⢠Correct problems and make sure they do not happen again
FDA Design Controls: What Medical Device Makers Need to KnowGreenlight Guru
Â
FDA Design Control regulations defined in 21 CFR 820.30 have been in place for 20 years now, yet year after year they continue to be one of the top issues cited during inspections.
This does not, and should not, be the case for your medical device company.
Join us for this free, two-part webinar series presented by two of the world's leading experts on the topic to learn how to implement a design control process that will not only ensure compliance but will actually benefit your product development efforts.
(You can view both webinars here: http://www.greenlight.guru/webinar/medical-device-design-controls)
In Part 1, you'll learn about Intended Use, User Needs, Design Inputs, Design Reviews, Design History File (DHF) and Risk Management.
Specifically:
-The importance of getting your intended use right up front
-The difference between a user need and a design input that's verifiable
-What stakeholders need to be involved in the process and why
-When and how many design reviews you should hold
-Why FMEA alone is NOT risk management and how to integrate risk into the design and development process
In Part 2, you'll learn about Design Outputs, Device Master Record (DMR), Design Verification and Validation (V&V), Design Transfer and Regulatory Submissions.
Specifically:
-Why your design outputs need to be more than a drawing and their relationship to your DMR
-How usability and human factors fits into the overall product development
-Making sure you build the correct device and build it correctly with design V&V
-Common mistakes people make during design transfer to production and how to avoid them
-When you can and should make your regulatory submission
The Top 10 Most Significant Changes Introduced by the New EU MDR (and how to ...Greenlight Guru
Â
As most of you have likely heard, the EU's new Medical Device Regulations (MDR) went into effect earlier this year replacing the old MDD and setting in motion a three-year countdown for manufacturers to comply to continue selling in the European market.
You also likely have a lot of questions about what do these changes mean, how can you begin preparing, how will they affect your company, what are their greatest implications, etc.?
Specifically, this presentation covers:
-How much will the new Medical Device Regulation cost?
-Why did it need to happen and what is the new structure?
-What additional activities does a manufacturer have to carry out?
-What are the top 10 most significant changes?
-What is EUDAMED and how has its role changed?
-And much more...
Watch the presentation here: https://www.greenlight.guru/webinar/eu-mdr-most-significant-changes
Medical devices â Quality management
systems â Requirements for regulatory
Purposes. ISO is an organization that develops Standards for use
worldwide.
ISO 13485 helps companies do their share in protecting
consumers and users of medical devices.
ISO 13485 Outlines criteria for a good Quality
Management System (QMS).
QMS criteria are good business practices ...
for example:
⢠Set Quality goals
⢠Ensure that regulations and other requirements are
understood and met
⢠Train employees
⢠Control your production processes
⢠Purchase from suppliers that can provide products that
meet your requirements
⢠Correct problems and make sure they do not happen again
Risk Management for Medical Devices - ISO 14971 Overview Greenlight Guru
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Risk Management for Medical Devices. An overview of ISO 14971 & how to apply a "Risk-based Approach" to your QMS processes to address the upcoming changes to ISO 13485.
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% â where software design failures are the most common reason for the recalls â itâs 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.
IEC 62304 is the international standard that defines software development lifecycle requirements for medical device software. The standard was developed from the perspective that product testing alone is insufficient to ensure patient safety when software is involved. The standard requires all aspects of the software development life cycle to be scrutinized.
Prepare your medical device for market with this Action List that walks you through the complexities of IEC 62304
Risk management in the development of medical devices. This presentation was for a webinar where we discussed the basics of risk management, a general risk management lifecycle, the requirements of certain relevant standards (ISO 14971, IEC 62304, US FDA Title 21 CFR Part 11), and the practical method called HFMEA. The live demonstration shows you how risks can be managed and compliance achieved using the advanced risk management features of codeBeamer ALM, and also demonstrates the use of our (general) FMEA template.
Design controls are not an easy subject to address during and after the design of medical devices and manufacturing processes. Design controls should drive the device design process, not be an afterthought. This session focuses on treating design as a separate entity within the quality management system, user needs vs. design inputs, continuation of design controls after the transfer process, design review and more.
Design Controls: Building Objective Evidence and Process Architecture to Mee...April Bright
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This session provides detailed examples to demonstrate what objective evidence is important to generate and use during design control compliance but, more importantly, to develop and issue a beneficial design history file meeting the requirements in 21 CFR, Part 820.30 and ISO 13485:2016. Aside from the importance of design controls for compliance, Mr. Gagliardi demonstrates how this section of the QS regulation and the ISO standard can be facilitated as a leading edge business tool.
Common Mistakes in the Medical Device Development ContinuumNAMSA
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Getting a medical device to market is a long process made up of multiple stages. Each stage requires a number of elements that need to be considered before progress can be made with the device. And even after market approval has been obtained, there is a continuous need to reevaluate and test the device to maintain safety and efficacy.
Throughout this development process, several steps can be missed that may result in submission refusal, or possibly a faulty device.
Risk Management for Medical Devices - ISO 14971 Overview Greenlight Guru
Â
Risk Management for Medical Devices. An overview of ISO 14971 & how to apply a "Risk-based Approach" to your QMS processes to address the upcoming changes to ISO 13485.
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% â where software design failures are the most common reason for the recalls â itâs 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.
IEC 62304 is the international standard that defines software development lifecycle requirements for medical device software. The standard was developed from the perspective that product testing alone is insufficient to ensure patient safety when software is involved. The standard requires all aspects of the software development life cycle to be scrutinized.
Prepare your medical device for market with this Action List that walks you through the complexities of IEC 62304
Risk management in the development of medical devices. This presentation was for a webinar where we discussed the basics of risk management, a general risk management lifecycle, the requirements of certain relevant standards (ISO 14971, IEC 62304, US FDA Title 21 CFR Part 11), and the practical method called HFMEA. The live demonstration shows you how risks can be managed and compliance achieved using the advanced risk management features of codeBeamer ALM, and also demonstrates the use of our (general) FMEA template.
Design controls are not an easy subject to address during and after the design of medical devices and manufacturing processes. Design controls should drive the device design process, not be an afterthought. This session focuses on treating design as a separate entity within the quality management system, user needs vs. design inputs, continuation of design controls after the transfer process, design review and more.
Design Controls: Building Objective Evidence and Process Architecture to Mee...April Bright
Â
This session provides detailed examples to demonstrate what objective evidence is important to generate and use during design control compliance but, more importantly, to develop and issue a beneficial design history file meeting the requirements in 21 CFR, Part 820.30 and ISO 13485:2016. Aside from the importance of design controls for compliance, Mr. Gagliardi demonstrates how this section of the QS regulation and the ISO standard can be facilitated as a leading edge business tool.
Common Mistakes in the Medical Device Development ContinuumNAMSA
Â
Getting a medical device to market is a long process made up of multiple stages. Each stage requires a number of elements that need to be considered before progress can be made with the device. And even after market approval has been obtained, there is a continuous need to reevaluate and test the device to maintain safety and efficacy.
Throughout this development process, several steps can be missed that may result in submission refusal, or possibly a faulty device.
Medtech start-ups from inception to exit: what are the key milestones and what are the ACTUAL timelines and costs?
A data-driven approach to figuring out the new reality of medical device venture capital investing.
With new technologies come many innovative medical devices and tools to help treat patients and to improve their quality of life thru diagnosis, monitoring and therapy. New fields of study within Engineering are emerging throughout the academic community to better understand and improve these devices and tools. As a Systems Engineer what are we doing in this application thatâs different from others? What are the challenges? What do we need to improve on? And Why?
This presentation provides an overview of the different types of Medical Devices and addresses the associated implications that affect the system under design. An example of a specific Medical Device will be presented along with a description of how the system integrates with Biological component. Systems Engineering Process comparison between Medical Device industry and Defense industry where Systems Engineering was conceived has been integrated throughout this presentation. You will learn more about some of the challenges that Medical Devices industry is facing and potential Systems Engineering solutions with specific approach and methodology.
When Medical Device Software Fails Due to Improper Verification & Validation ...Sterling Medical Devices
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Verification and validation are critical components in the development life cycle of any software and the results of the V & V process are imperative to the safety of the medical device.
This is a DRAFT (not the final version) of a PRD I did while working at Jewelry Television (JTV). Serving as a E-commerce Product Manager was part of my job at JTV, and I wrote many of these PRDs and BRDs (Business Requirements Documents), of varying lengths and complexity. This one, though not complete, is fairly detailed.
Rick Wingender
Rick Wingender Consulting: www.wingender.us
Business requirements gathering and analysisMena M. Eissa
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Business analysis and requirements management are a key to project success.
This workshop helps candidates perform better based on sharing real life experience with them.
Requirements flexibel und agil managen am Beispiel Jama Contourpd7.group
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Requirements flexibel und agil managen am Beispiel Jama Contour
Ein Webinar von Software.Process.Management fĂźr die QA Systems Akademie
Referenten: Dr. Andreas Birk und Gerald Heller
Inhalte:
- Requirements systematisch klären und definieren
- Requirements Change Management & Reviews
- Agiles Requirements-Management
Retrospective and Trends in Requirements Engineering for Embedded Systems: A ...TarcĂsio Couto
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In the embedded systems (ES) area, more than 50% of problems occur at system delivery and are related to misconceptions in capturing requirements. Also, requirements engineering (RE) is crucial to meet time, cost, and quality goals. An important step to improve the RE approaches for ES is to gain a detailed understanding of the retrospective and trends presented by the literature. We have conducted a systematic literature review to gain an in-depth understanding of trends and needs concerning RE research. We report on the main results of our study related to three research questions: what requirements should be considered during ES development? what are the RE contributions for ES? and what challenges/problems are identied in the research literature to RE for ES? Based on the results of the study, we draw conclusions for future RE research.
This ppt explains about the FAQ's in software engineering and software engineer profession and ethics of software engineer.
Difference between the system engineer and software engineer.
This presentation is about a lecture I gave within the "Software systems and services" immigration course at the Gran Sasso Science Institute, L'Aquila (Italy): http://cs.gssi.infn.it/.
http://www.ivanomalavolta.com
Systems Engineering is a very broad , overarching, and generally applicable engineering discipline. Many types of systems are developed using SE. These include biomedical systems, space vehicle systems, weapon systems, transportation systems, and so on.
Systems Engineering involves the coordination of work performed by engineers from all other engineering disciplines (electrical, mechanical, computer, software, etc.) as required to complete the engineering work on the project/program.
Transcript: Selling digital books in 2024: Insights from industry leaders - T...BookNet Canada
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The publishing industry has been selling digital audiobooks and ebooks for over a decade and has found its groove. Whatâs changed? What has stayed the same? Where do we go from here? Join a group of leading sales peers from across the industry for a conversation about the lessons learned since the popularization of digital books, best practices, digital book supply chain management, and more.
Link to video recording: https://bnctechforum.ca/sessions/selling-digital-books-in-2024-insights-from-industry-leaders/
Presented by BookNet Canada on May 28, 2024, with support from the Department of Canadian Heritage.
Software Delivery At the Speed of AI: Inflectra Invests In AI-Powered QualityInflectra
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In this insightful webinar, Inflectra explores how artificial intelligence (AI) is transforming software development and testing. Discover how AI-powered tools are revolutionizing every stage of the software development lifecycle (SDLC), from design and prototyping to testing, deployment, and monitoring.
Learn about:
⢠The Future of Testing: How AI is shifting testing towards verification, analysis, and higher-level skills, while reducing repetitive tasks.
⢠Test Automation: How AI-powered test case generation, optimization, and self-healing tests are making testing more efficient and effective.
⢠Visual Testing: Explore the emerging capabilities of AI in visual testing and how it's set to revolutionize UI verification.
⢠Inflectra's AI Solutions: See demonstrations of Inflectra's cutting-edge AI tools like the ChatGPT plugin and Azure Open AI platform, designed to streamline your testing process.
Whether you're a developer, tester, or QA professional, this webinar will give you valuable insights into how AI is shaping the future of software delivery.
UiPath Test Automation using UiPath Test Suite series, part 4DianaGray10
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Welcome to UiPath Test Automation using UiPath Test Suite series part 4. In this session, we will cover Test Manager overview along with SAP heatmap.
The UiPath Test Manager overview with SAP heatmap webinar offers a concise yet comprehensive exploration of the role of a Test Manager within SAP environments, coupled with the utilization of heatmaps for effective testing strategies.
Participants will gain insights into the responsibilities, challenges, and best practices associated with test management in SAP projects. Additionally, the webinar delves into the significance of heatmaps as a visual aid for identifying testing priorities, areas of risk, and resource allocation within SAP landscapes. Through this session, attendees can expect to enhance their understanding of test management principles while learning practical approaches to optimize testing processes in SAP environments using heatmap visualization techniques
What will you get from this session?
1. Insights into SAP testing best practices
2. Heatmap utilization for testing
3. Optimization of testing processes
4. Demo
Topics covered:
Execution from the test manager
Orchestrator execution result
Defect reporting
SAP heatmap example with demo
Speaker:
Deepak Rai, Automation Practice Lead, Boundaryless Group and UiPath MVP
The Art of the Pitch: WordPress Relationships and SalesLaura Byrne
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Clients donât know what they donât know. What web solutions are right for them? How does WordPress come into the picture? How do you make sure you understand scope and timeline? What do you do if sometime changes?
All these questions and more will be explored as we talk about matching clientsâ needs with what your agency offers without pulling teeth or pulling your hair out. Practical tips, and strategies for successful relationship building that leads to closing the deal.
Dev Dives: Train smarter, not harder â active learning and UiPath LLMs for do...UiPathCommunity
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đĽ Speed, accuracy, and scaling â discover the superpowers of GenAI in action with UiPath Document Understanding and Communications Miningâ˘:
See how to accelerate model training and optimize model performance with active learning
Learn about the latest enhancements to out-of-the-box document processing â with little to no training required
Get an exclusive demo of the new family of UiPath LLMs â GenAI models specialized for processing different types of documents and messages
This is a hands-on session specifically designed for automation developers and AI enthusiasts seeking to enhance their knowledge in leveraging the latest intelligent document processing capabilities offered by UiPath.
Speakers:
đ¨âđŤ Andras Palfi, Senior Product Manager, UiPath
đŠâđŤ Lenka Dulovicova, Product Program Manager, UiPath
State of ICS and IoT Cyber Threat Landscape Report 2024 previewPrayukth K V
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The IoT and OT threat landscape report has been prepared by the Threat Research Team at Sectrio using data from Sectrio, cyber threat intelligence farming facilities spread across over 85 cities around the world. In addition, Sectrio also runs AI-based advanced threat and payload engagement facilities that serve as sinks to attract and engage sophisticated threat actors, and newer malware including new variants and latent threats that are at an earlier stage of development.
The latest edition of the OT/ICS and IoT security Threat Landscape Report 2024 also covers:
State of global ICS asset and network exposure
Sectoral targets and attacks as well as the cost of ransom
Global APT activity, AI usage, actor and tactic profiles, and implications
Rise in volumes of AI-powered cyberattacks
Major cyber events in 2024
Malware and malicious payload trends
Cyberattack types and targets
Vulnerability exploit attempts on CVEs
Attacks on counties â USA
Expansion of bot farms â how, where, and why
In-depth analysis of the cyber threat landscape across North America, South America, Europe, APAC, and the Middle East
Why are attacks on smart factories rising?
Cyber risk predictions
Axis of attacks â Europe
Systemic attacks in the Middle East
Download the full report from here:
https://sectrio.com/resources/ot-threat-landscape-reports/sectrio-releases-ot-ics-and-iot-security-threat-landscape-report-2024/
UiPath Test Automation using UiPath Test Suite series, part 3DianaGray10
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Welcome to UiPath Test Automation using UiPath Test Suite series part 3. In this session, we will cover desktop automation along with UI automation.
Topics covered:
UI automation Introduction,
UI automation Sample
Desktop automation flow
Pradeep Chinnala, Senior Consultant Automation Developer @WonderBotz and UiPath MVP
Deepak Rai, Automation Practice Lead, Boundaryless Group and UiPath MVP
Slack (or Teams) Automation for Bonterra Impact Management (fka Social Soluti...Jeffrey Haguewood
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Sidekick Solutions uses Bonterra Impact Management (fka Social Solutions Apricot) and automation solutions to integrate data for business workflows.
We believe integration and automation are essential to user experience and the promise of efficient work through technology. Automation is the critical ingredient to realizing that full vision. We develop integration products and services for Bonterra Case Management software to support the deployment of automations for a variety of use cases.
This video focuses on the notifications, alerts, and approval requests using Slack for Bonterra Impact Management. The solutions covered in this webinar can also be deployed for Microsoft Teams.
Interested in deploying notification automations for Bonterra Impact Management? Contact us at sales@sidekicksolutionsllc.com to discuss next steps.
Builder.ai Founder Sachin Dev Duggal's Strategic Approach to Create an Innova...Ramesh Iyer
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In today's fast-changing business world, Companies that adapt and embrace new ideas often need help to keep up with the competition. However, fostering a culture of innovation takes much work. It takes vision, leadership and willingness to take risks in the right proportion. Sachin Dev Duggal, co-founder of Builder.ai, has perfected the art of this balance, creating a company culture where creativity and growth are nurtured at each stage.
GDG Cloud Southlake #33: Boule & Rebala: Effective AppSec in SDLC using Deplo...James Anderson
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Effective Application Security in Software Delivery lifecycle using Deployment Firewall and DBOM
The modern software delivery process (or the CI/CD process) includes many tools, distributed teams, open-source code, and cloud platforms. Constant focus on speed to release software to market, along with the traditional slow and manual security checks has caused gaps in continuous security as an important piece in the software supply chain. Today organizations feel more susceptible to external and internal cyber threats due to the vast attack surface in their applications supply chain and the lack of end-to-end governance and risk management.
The software team must secure its software delivery process to avoid vulnerability and security breaches. This needs to be achieved with existing tool chains and without extensive rework of the delivery processes. This talk will present strategies and techniques for providing visibility into the true risk of the existing vulnerabilities, preventing the introduction of security issues in the software, resolving vulnerabilities in production environments quickly, and capturing the deployment bill of materials (DBOM).
Speakers:
Bob Boule
Robert Boule is a technology enthusiast with PASSION for technology and making things work along with a knack for helping others understand how things work. He comes with around 20 years of solution engineering experience in application security, software continuous delivery, and SaaS platforms. He is known for his dynamic presentations in CI/CD and application security integrated in software delivery lifecycle.
Gopinath Rebala
Gopinath Rebala is the CTO of OpsMx, where he has overall responsibility for the machine learning and data processing architectures for Secure Software Delivery. Gopi also has a strong connection with our customers, leading design and architecture for strategic implementations. Gopi is a frequent speaker and well-known leader in continuous delivery and integrating security into software delivery.
GDG Cloud Southlake #33: Boule & Rebala: Effective AppSec in SDLC using Deplo...
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Systems Engineering and Requirements Management in Medical Device Product Development
1. Systems Engineering and
R i t M tRequirements Management
in Medical Device Product
Development
Todd HansellTodd Hansell
Director, Systems Design Quality Assurance
Covidien
February 16, 2012
todd hansell@covidien comtodd.hansell@covidien.com
303-530-6306
COVIDIEN, COVIDIEN with logo, Covidien logo, positive results for life and ⢠marked brands are U.S. and internationally registered trademarks of Covidien AG. R0027846
2. Background
Todd Hansell, Speaker
⢠Director of Design Quality Assurance & Reliability Engineering
â Electrical and mechanical hardware
â Software Quality and Design Assurance
A t t d t t t d l tâ Automated test system development
⢠Joined Covidien (formerly Valleylab) in 2003
⢠Education:
â BSEE Purdue University, 1989
â SW Engineering Masters Certificate, University of Colorado at
Boulder, 2004
⢠Twenty-three years of experience in the automotive, industrial and
medical industries
⢠Software engineering, software quality assurance, systems engineering,
technical management organizational process improvement risktechnical management, organizational process improvement, risk
management
Covidien, Surgical Solutions Group
⢠Market leader in radiofrequency (RF) electrosurgical generators and
instruments, vessel/tissue sealing technologies (RF and mechanical
stapling)
⢠Soft tissue ablation technology (RF, microwave)
⢠Boulder, Colorado, and North Haven, Connecticut
2 | 16 February 2012
3. Whatâs Been AdvertisedâŚ
An overview of systems engineering and requirements management in
medical device product development.
⢠What is systems engineering?
⢠Systems engineering and the FDA
⢠The role of the systems engineer in new product developmente o e o e sys e s e g ee e p oduc de e op e
⢠Systems engineering maturity models and best practices
⢠Requirements engineering and requirements management â the
foundation of systems engineering
Tools and methods for systems engineering⢠Tools and methods for systems engineering
⢠Systems engineering and product quality
⢠Systems verification and validation
⢠Accelerating new product development with systems engineeringg p p y g g
3 | 16 February 2012
4. What is Systems Engineering?
What is a System?
A combination of interacting elements organized to achieve one or more stated purposes
(INCOSE) [1](INCOSE).[1]
What is Systems Engineering?
Systems engineering is an iterative process of top-down synthesis, development, and
operation of a real-world system that satisfies in a near optimal manner the full range ofoperation of a real world system that satisfies, in a near optimal manner, the full range of
requirements for the system. (Eisner)
Systems Engineering is an interdisciplinary approach and means to enable the realization
of successful systems. It focuses on defining customer needs and required functionalityy g q y
early in the development cycle, documenting requirements, and then proceeding with
design synthesis and system validation while considering the complete problem:
operations, cost and schedule performance, training and support, test, manufacturing, and
disposal. SE considers both the business and technical needs of all customers with the
l f idi li d h h d (INCOSE)goal of providing a quality product that meets the user needs.(INCOSE)
Differs from other specialist disciplines of engineering, focus on technical coordinationDiffers from other specialist disciplines of engineering, focus on technical coordination
4 | 16 February 2012
5. What Do Systems Engineers Do?
⢠Identification and quantification of system goals & requirements
⢠Creation of alternative system design conceptsy g p
⢠Performance of design trades
⢠Selection and implementation of the best design
(balanced and robust)
⢠Verification that the design is actually built and properly integrated in
accordance with specifications
⢠Assessment of how well the system meets the goals
Best career in America (Money magazine 2009)Best career in America (Money magazine, 2009)
â˘High median salary compared to other engineering disciplines
â˘Predicted 45% growth over 1st half of this decade
5 | 16 February 2012
6. Why Do We Need Systems Engineering?
Competitive pressures from the rapid advancement of integrated technologies
⢠Increased product complexity
⢠Reduction of product development cycle time
I d f t d l t i t⢠Increased safety and regulatory requirements
⢠Globalization of the marketplace and workforce
⢠Software as a dominant force of change in new products
⢠Worldwide deployment of new technology on ever-shorter time scales
S t t t d f i ti t i t ll t l t⢠Systems constructed from pre-existing components or intellectual property
⢠Re-use of components, information, and knowledge across projects
⢠Transition from paper-based control to electronically managed information
⢠The rise of intellectual capital as the primary asset of many modern organizations
6 | 16 February 2012
INCOSE Handbook, [2]
7. A Brief History of Systems Engineering
⢠Water Distribution Systems in Mesopotamia 4000 BC
⢠Irrigation Systems in Egypt 3300 BC
⢠Urban Systems such as Athens, Greece 400 BCy ,
⢠Roman Highway Systems 300 BC
⢠Water Transportation Systems like Erie Canal 1800s
⢠Telephone Systems 1877
⢠Electrical Power Distribution Systems 1880y
⢠Systems engineering concepts at Bell Labs and in the military (World War II) 1900s
⢠Term conceived at Bell Telephone Laboratories 1940
⢠DOD applied systems engineering to missiles and missile defense 1940s
⢠RAND Corporation (US Air Force) developed systems analysis 1946
⢠ATLAS ICBM Program Managed by Ramo-Wooldridge Corp 1954-1964
⢠Defense Systems Management College (DMSC) 1971
⢠National Council on Systems Engineering 1990
⢠International Council on Systems Engineering (INCOSE) 1995
⢠75 US 141 international universities offer systems engineering programs 2006⢠75 US, 141 international universities offer systems engineering programs 2006
7 | 16 February 2012
8. Systems Thinking
Definition:
The process of understanding how things influence one another
within a wholewithin a whole
Foundation in the field of system dynamics by Jay Forester in 1956 at MIT
⢠Applying engineering principles to social systems
⢠Study interactions vs decomposition and constituent analysis
Basic Tenets
⢠Interdependence of objects and their attributes - independent elements can never constitute a system
⢠Holism - emergent properties not possible to detect by analysis should be possible to define by a holistic
approach
G f⢠Goal seeking - systemic interaction must result in some goal or final state
⢠Inputs and Outputs - in a closed system inputs are determined once and constant; in an open system
additional inputs are admitted from the environment
⢠Transformation of inputs into outputs - this is the process by which the goals are obtained
⢠Entropy - the amount of disorder or randomness present in any system⢠Entropy - the amount of disorder or randomness present in any system
⢠Regulation - a method of feedback is necessary for the system to operate predictably
⢠Hierarchy - complex wholes are made up of smaller subsystems
⢠Differentiation - specialized units perform specialized functions
⢠Equifinality - alternative ways of attaining the same objectives (convergence)q y y g j ( g )
⢠Multifinality - attaining alternative objectives from the same inputs (divergence)
8 | 16 February 2012
Weinberg, [4]
9. Why Use Systems Engineering?
Develops, drives, implements, leads, standardizes, reuses, predicts, adapts,
communicates, improves, analyzesâŚ
1. Standardized deliverables
2. Decomposition process of customer requirements
3. System functionality that meets customerâs expectation
4. Commitment to faster time to market
5. Systems that can evolve with a minimum of redesign and cost
6. Designs for systems reuse
7. More predictable outcomes
8. Products with adaptable, resilient systems
9. Verified functionality with fewer defects
10 I d i ti10. Improved communications
a. Across functions
b. Programs
c. Teams
11 Managed complexity11. Managed complexity
Industry Data
⢠Cost and schedule overruns minimized with >10% SE effort
⢠Survey: Of the top eight reasons for project failures: five related to requirements, three toy p g p j q
management
⢠See SEI (Software Engineering Institute for data on Systems Engineering process improvement)
9 | 16 February 2012
10. Systems Engineering and the FDA
âElectronic, software, and systems engineering concerns lie at the heart of the problems
encountered with most of the sophisticated new medical devices regulated by the Agency. A
critical core of expertise has been developed in each of these areas to address Center
needsneeds.
Historically, many device problems arise at the intersections of hardware and software, the
user, the manufacturing process and the use environment. A broad range of analytical tools
are available to systems engineering specialists to help them identify such problems and
take reasonable steps to prevent or limit the problems and/or mitigate the consequences.
âŚThe term system effectiveness has been used in industry to describe the range of
concerns addressed by these analytical techniques, including the following:
reliabilityreliability
dependability
maintainability
manufacturability
testability
ser iceabilitserviceability
capability
safety engineering and risk management
metrology â
See FDA web site:
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm126804.htm
10 | 16 February 2012
12. A Typical âWaterfallâ Life Cycle Model
Concept
Voice of the customer, concept development, business plan
Feasibilityeas b ty
Definition of customer and system requirements, project plan and schedule
Development
Develop/implement/document product design, develop V&V strategy
Qualification
Execute product V&V, validate manufacturing processes, prepare for volume
production
Commercialization
Product launched, achieve stable production
Sustaining support
Ongoing product changes, enhancements, address complaints, reliability
12 | 16 February 2012
13. The Systems Engineering V Model
User
requirements
Validation
Tests
Validation
System
Requirements
System Tests
Verification
Requirements
IntegrationArchitectural
VerificationDefining the
d t
Integrating
& verifying
what has
been b ilt
g
TestsDesign
product been built
Abstract,
early, formative,
creative, conducive
Systems Engineering
Component Engineering
Component
Development
Component
Tests
to change
Expensive, realistic,
late, difficult to change
Component Engineering
13 | 16 February 2012
Stevens, [6]
14. ISO /IEC 15288: 2008 Systems and Software
E i i S t Lif C l PEngineering â Systems Life Cycle Processes
14 | 16 February 2012
INCOSE Handbook, [2]
15. Capability Maturity Model Integration (CMMI) (Version 1.3)
Level Focus Process Area
5 Optimizing Continuous Process Improvement â˘Organizational Performance Management
â˘Causal Analysis and Resolution
4 Quantitatively
Managed
Management by Metrics â˘Organizational Process Performance
â˘Quantitative Project Management
3 Defined Process Standardization â˘Requirements Development
â˘Technical Solution
â˘Product Integration
â˘Verification
â˘Validation
â˘Organizational Process Focus
â˘Organizational Process Definition + IPPD
â˘Organizational Training
â˘Integrated Project Management + IPPD
â˘Risk Management
â˘Decision Analysis and Resolution
2 Managed Basic Project Management â˘Requirements Management
â˘Project Planning
â˘Project Monitoring and Control
â˘Supplier Agreement Management
â˘Measurement and Analysis
â˘Process and Product Quality Assurance
â˘Configuration Management
1 Initial Individual Heroism â˘None
15 |
16. CMMI Solid FoundationsâŚ
5Org. Perf. Mgmt
4Quantitative Project Management
Causal Analysis and Resolution
Requirements Development
Technical Solution
Verification
Organizational Training
Validation
3
Organizational Process Performance
R i t M t P j t M it i d C t l
Product Integration
Verification
Organizational Process Definition + IPPD
Organizational Process Focus
Risk Management
Integrated Project Management + IPPD
Decision Analysis and Resolution
3
2Requirements Management
Project Planning
Project Monitoring and Control
Supplier Agreement Management
Measurement and Analysis
Process and Product Quality Assurance
Configuration Management 2
16 | 16 February 2012
17. Example: Requirements Management
Requirements Management (REQM) â Maturity Level 2
(Process Management)
Purpose
The purpose of Requirements Management (REQM) is to manage
requirements of the projectâs products and product components and to
ensure alignment between those requirements and the projectâs plans andensure alignment between those requirements and the project s plans and
work products.
Specific Practices by Goal
SG 1 M R i tSG 1 Manage Requirements
â SP 1.1 Understand Requirements
â SP 1.2 Obtain Commitment to Requirements
â SP 1.3 Manage Requirements Changes
SP 1 4 M i t i Bidi ti l T bilit f R i tâ SP 1.4 Maintain Bidirectional Traceability of Requirements
â SP 1.5 Ensure Alignment Between Project Work and Requirements
17 |
18. Example: Requirements Development
Requirements Development (RD)
An Engineering process area at Maturity Level 3.
PurposePurpose
The purpose of Requirements Development (RD) is to elicit, analyze, and
establish customer, product, and product component requirements.
Specific Practices by Goaly
SG 1 Develop Customer Requirements
â SP 1.1 Elicit Needs
â SP 1.2 Transform Stakeholder Needs into Customer Requirements
SG 2 Develop Product Requirements
SP 2 1 E t bli h P d t d P d t C t R i tâ SP 2.1 Establish Product and Product Component Requirements
â SP 2.2 Allocate Product Component Requirements
â SP 2.3 Identify Interface Requirements
SG 3 Analyze and Validate Requirements
â SP 3 1 Establish Operational Concepts and Scenariosâ SP 3.1 Establish Operational Concepts and Scenarios
â SP 3.2 Establish a Definition of Required Functionality and Quality Attributes
â SP 3.3 Analyze Requirements
â SP 3.4 Analyze Requirements to Achieve Balance
â SP 3.5 Validate Requirementsq
18 |
19. Benefits of Structured Process Improvement
Improvements
⢠Cost
⢠Schedule
⢠Productivity
⢠Quality
⢠Customer Satisfaction
Risk ReductionRisk Reduction
⢠Reduce risk of regulatory non-compliance
Reduce Frustration!
⢠Lower turnover of key talentLower turnover of key talent
ROI
Organizations which have invested in CMMI-based process improvements
have seen an ROI ranging from 2:1 to 13:1g g
See SEI web site:
http://www.sei.cmu.edu/publications/documents/03.reports/03sr009.html
19 | 16 February 2012
20. CIMM â The Missing Levels (Humor)
0 : Negligent0 : Negligent
The organization pays lip service, often with excessive fanfare, to implementing software engineering
processes, but lacks the will to carry through the necessary effort. Whereas CMM level 1 assumes
eventual success in producing software, CIMM level 0 organizations generally fail to produce any
product, or do so by abandoning regular procedures in favor of crash programs.product, or do so by abandoning regular procedures in favor of crash programs.
-1 : Obstructive
Processes, however inappropriate and ineffective, are implemented with rigor and tend to obstruct work.
Adherence to process is the measure of success in a Level -1 organization. Any actual creation of viable
product is incidental. The quality of any product is not assessed, presumably on the assumption that if
the proper process was followed, high quality is guaranteed.
Paradoxically, Level -1 organizations believe fervently in following defined procedures, but lacking the
will to measure the effectiveness of the procedures they rarely succeed at their basic task of creating
software.
2 C t t-2 : Contemptuous
While processes exist, they are routinely ignored by engineering staff and those charged with overseeing
the processes are regarded with hostility. Measurements are fudged to make the organization look good.
This is not a good environment to work in or be associated with.
-3 : Undermining-3 : Undermining
Not content with faking their own performance, undermining organizations routinely work to downplay
and sabotage the efforts of rival organizations, especially those successfully implementing processes
common to CMM level 2 and higher. This is worst where company policy causes departments to
compete for scarce resources, which are allocated to the loudest advocates.p ,
Schorsch, [7]
20 | 16 February 2012
21. (Over) Simplified View of Product Development
E ti D i
Final Product
Innovation Domain
â˘Low uncertainty
â˘Low risk
Execution Domain
â˘Safe and effective
â˘Manufacturable
â˘Reliable
â˘Affordable
â˘Few defects
â˘Few assumptions
â˘âHardâ (physical prototypes)
â˘Iteration is very expensive
Conceptual
Design
Model
(one of
many!)
Mature
Design
Model â˘Quality System
â˘Engineering
ProcessesHigh uncertainty Processes
â˘OperationsIdea
â˘High uncertainty
â˘High risk
â˘Many assumptions
â˘âSoftâ (paper, electronic
models)
â˘Iteration is inexpensive
Systems Engineering
Process
Covidien | | Confidential
âGainâ
22. Systems Engineering and Quality:Systems Engineering and Quality:
Verification
22 | 16 February 2012
23. Approaches to Systems Verification
A Quality Strategy must be integrated into entire life cycle
⢠Systems Verification and Validation Plan
T bilit i t i d th h t⢠Traceability maintained throughout
Approaches to Verification
⢠Inspectionspec o
⢠Analysis
⢠Demonstration
⢠Test
Certification⢠Certification
Test Categories
⢠Development Testp
⢠Qualification Test
⢠Acceptance Test
⢠Operational Test
23 | 16 February 2012
27. Useful Tools â Some Examples
Requirements Management Tools
⢠Examples: IBM DOORSâ˘, ReqProâ˘, etc.
⢠Features:
⢠Requirements Database (usually object-oriented)q ( y j )
⢠Requirements can have attributes and links
⢠Supports document generation, automates traceability management
⢠Enables information-centric vs document-centric view of project information
System Modeling ToolsSystem Modeling Tools
⢠Examples: Enterprise Architectâ˘, IBM Rhapsodyâ˘, Altova UModelâ˘, etc.
⢠Features:
⢠Implement UML or SysML(Systems Modeling Language)
â˘SysML â tailored for systems engineeringy y g g
â˘See http://www.omgsysml.org for more information
⢠Executable models, systems analysis, software code generation
27 | 16 February 2012
28. Systems Engineering and the SafetySystems Engineering and the Safety
Risk Management Process
28 | 16 February 2012
29. When Risks Go Unconsidered in Medical DevicesâŚ
The Therac-25 Disaster
Medical linear accelerator for tumor treatment
⢠Based upon previously successful hardware-based design⢠Based upon previously successful, hardware-based design
⢠Software controlled safety system (cost savings)
⢠Low- and high-power modes
⢠Timing problems with command response caused patient to be treated with
125 times intended radiation dosageg
⢠Six deaths
⢠Causes:
â Poor, incomplete testing and quality strategy
â Failure to properly assess old software when applied to new equipment
Poorly designed error and warning messagesâ Poorly designed error and warning messages
â Did not fix or understand recurring problems
â Hardware backups for safety system
â LACK OF SOUND SYSTEMS ENGINEERING!
⢠For more details, see the landmark paper by Nancy Leveson, Therac-25, p p y y ,
Accidents: An Updated Version of the Original Accident Investigation Paper
www.cs.washington.edu/research/projects/safety/www/therac-25.html
29 | 16 February 2012
30. ISO 14971:2007 â Harmonized Standard for
Ri k M tRisk Management
â⌠provides manufacturers with a
framework within which experience, insightframework within which experience, insight
and judgment are applied systematically to
manage risks associated with the use of
medical devices.â
â⌠a self-improving process through which
the manufacturer must use knowledge
gained post-production to improve and
refine the safety of the device ârefine the safety of the device.â
Compliance with this standard is rapidly becoming a general requirement of
regulatory bodies worldwide.regulatory bodies worldwide.
30 | 16 February 2012
31. IEC 60601-1:2005 (3rd Edition)
A New Standards ParadigmA New Standards Paradigm
A Risk-Based Approach to Medical Device Safety
⢠Requirements can be tailored to the realities of a particular device and its intended use based
upon assessed riskupon assessed risk.
â Some requirements may be waived altogether (with justification)
â In cases of high safety risk, device must meet requirements beyond what the standard
specifies
I t t t t b d t i d b d f t i kâ In many cases, test parameters must be determined based upon safety risk
(vs. prescribed test parameters)
⢠Requires an intimate understanding of the design and functionality of the device being
assessed
⢠Requires a risk management process compliant with ISO14971:2007.
â Risk management file becomes a central repository for critical verification information
and decision-making
⢠More than 100 references where the application of a clause modification of a test protocol orMore than 100 references where the application of a clause, modification of a test protocol or
provision of a safety feature are dependent upon a documented risk analysis.
The Result: A flexible standard that is much easier to adapt to changing technology, with a
higher (but appropriate!) burden of responsibility on the device manufacturer to demonstrate the
f t f it d isafety of its device.
The Impact: Compliance required for international certifications June, 2012 (FDA June, 2013)
31 | 16 February 2012
32. Other Risk-Based Standards for Medical Devices
ISO 13485:2003 Quality Management Systems
⢠âThe organization shall establish documented requirements for risk management throughout
product realization. Records arising from risk management shall be maintained.â
ISO 62304:2006 Medical Device Software
⢠Explicitly requires a formal risk management process (14971-compliant) to be applied at
many stages in the software development lifecycle
⢠Standard recently recognized by the FDA
GAMP 5 (ISPE 2008): Risk Based Approach to Compliant GxP Computerized SystemsGAMP 5 (ISPE â 2008): Risk-Based Approach to Compliant GxP Computerized Systems
Stay tuned. More are on the way!
Bottom line â Adopting a risk-based approach to product development and verification
is really the only option!
32 | 16 February 2012
33. A Risk-Driven Process âŚ
An integrated risk management process is essential to successful medical
device development.
Risk analysis
(fault tree) Product
i t
Risk-based
Risk-based Methods
Design FMEA
Process FMEA
requirementsstandards
(e.g., 14971,
60601-1,
62304 etc )
Safety requirements
(incl. 60601-1 & particular stds.)
Product
design
specifications
Application FMEA
62304, etc.)
Functional
requirements
Product verification tests
33 | 16 February 2012
35. Why requirements?
Provide a means to formally verify and validate that our devices are safeProvide a means to formally verify and validate that our devices are safe,
effective, and reliable.
Communicate voice of customer to the design team.
35 | 16 February 2012
36. Definition of Requirement
In engineering, a requirement is a singular documented need of what a
particular product or service should be or perform.p p p
A derived or technical requirement is a distinct testable verifiable
characteristic or attribute of a system, system element, or system structural
componentcomponent.
A requirement is captured in a single complete sentence.
A requirement sentence is written as a SHALL statement.
A derived requirement is verifiable.
â A met need or met intended use is validated.
36 | 16 February 2012
37. Verification
Verification is the process which makes sure that what was built matches the
requirements. Was the system built the way the requirements and designq y y q g
specified?
Was the system built ârightâ?Was the system built right ?
37 | 16 February 2012
38. Validation
Validation determines if the system being developed will meet the intendedValidation determines if the system being developed will meet the intended
needs of the systemâs owner and stakeholders when completed. Does the
system solve the problem or issue that it was intended to solve? Does it
solve it to the expected extent?
Validation answers the questionâŚ
Was the ârightâ system built?
38 | 16 February 2012
39. Communicating - Decomposition
Customer Requirements
Marketing âNeeds & Desiresâ
RequirementsRequirements
Systems Engineering Decomposes
Customer/Marketing ReqtsCustomer/Marketing Reqts.
Into Top-level Systems Requirements
Sub system RequirementsSub-system Requirements
Derived from Top-level
Requirements
39 | 16 February 2012
40. Communicating
Customer Requirements
Usability
Cus o e equ e e s
Marketing âNeeds & Desiresâ
R i t
Prototype
/Mock-up
Requirements
Systems Engineering Decomposes
Customer/Marketing Requirements
Into Systems Requirements
Sub system RequirementsSub-system Requirements
Derived from Top-level
RequirementsTechnical
Development
(Tech Dev) Sustainability
40 | 16 February 2012
41. Requirement Goal - Traceability
Customer/Marketing â Define Stakeholders
⢠Needs: âMust Haveâ
D i âNi t H â âD li ht â⢠Desires: âNice to Haveâ, âDelightersâ
System
⢠Translate Customer Requirements to Engineering Requirementsa s a e Cus o e equ e e s o g ee g equ e e s
⢠Convert Subjective to Objective
⢠Communication Tool â Customer to Development Team,
Verification Method (Test) Team Validation Team
Sub-System
⢠Higher Resolution
⢠Specific to Function/Sub-systemp y
⢠Communication Tool â Sub-Contractor, Verification Method (Test) Team
41 | 16 February 2012
42. Requirements Gathering Phase
⢠Decompose requirements (derived requirements)
B i t / di i t⢠Brainstorm / discover requirements
⢠Capture Standards Requirements
⢠Ensure all regulatory, project-specific physical requirements are
captured
42 | 16 February 2012
43. Requirements Analysis Phase
⢠Derive safety requirements from risk management plan
⢠Organize and Scrub requirements
⢠!! Delete orphan requirements !!
⢠Review & validate requirements
43 | 16 February 2012
44. Requirements Analysis Phase
⢠Iterate and maintain requirements
⢠Baseline requirements (sets)
⢠Release requirements
⢠Iterate throughout the product development life cycle⢠Iterate throughout the product development life cycle
⢠Apply change control to requirements â CCB!
44 | 16 February 2012
46. 5 Principles for Good Requirements
1. Communicate Input to Design
â WHAT are we solving? Not why⌠not howâŚg y
â Does the cross-functional team understand requirement?
2. Verifiable
â Verification is possible by a Verification Method(s);
TEST similarity analysis inspection demonstration observationTEST, similarity, analysis, inspection, demonstration, observation
â Safety and criticality should determine a requirementâs
verification method.
â Is a statement a requirement if it cannot be verified?
3. Requirements are Focused â audience is known
4. Avoid constraining the designers
5. Free of Specific Design Content â NOT a specification, NOT a
design solution / design outputdesign solution / design output
46 | 16 February 2012
47. Questions to askâŚ
⢠Is the requirement correct?
⢠Is the requirement verifiable?⢠Is the requirement verifiable?
⢠Is the requirement clear?
⢠Is the requirement consistent?
⢠Is the requirement feasible?
47 | 16 February 2012
Telelogic DOORS, [8]
48. Writing Good Requirements
⢠Avoid and/or conjunctions (one at a time)
The system shall operate at
a power level of...
The software shall
⢠Avoid exceptions (but, unless, except)
⢠Define verifiable criteria or expected result
s f s
acquire data fromâŚ
The structure shall
withstand loads ofâŚ
⢠Organize related requirements
⢠Group together related derived requirements
G t th i t i t i t d l ( id th 800
s s f
⢠Group together requirements into appropriate modules (avoid the 800-page
document!)
⢠Avoid kitchen sink syndrome
⢠Requirements define âwhatâ â not âhowâ, not âwhyâ
48 | 16 February 2012
49. Examples â Good/Bad/Ugly
Good
⢠The Theta Axis shall be capable of 2.10 radians/sec.
Bad
⢠The software (SW) architecture needs to be flexible and modular.
Ugly
⢠The User Interface (UI) shall produce a system response within 10
milliseconds (msec) of contact by user.
â Good intention bad input; what is a response?Good intention, bad input; what is a response?
â The user may not be capable of noticing a difference between 10
msec and 200 msec. The requirement may overly constrain the
design team.
Document âwhyâ the constraint
49 | 16 February 2012
50. Negative (Anti-) Requirements
Negative requirements should not be written as a general rule.
Examples:
The device software shall not fail.
The device software shall not activate energy when a non-recoverable
error is present.
Better:
The device software shall allow for 96 hours of continuous operation.
The device software shall inhibit energy delivery after occurrence of a non-
recoverable error.
⢠Why? Burden of proof is greater for a negative requirement Proving aWhy? Burden of proof is greater for a negative requirement. Proving a
negative requirement may be altogether impossible.
50 | 16 February 2012
51. Requirement Qualifiers
Qualifiers follow an âif then constructâ
Example of one too many qualifiers:
During energy activation, if the user releases the activation switch before sealing has been
determined to be successfully completed, the generator software shall deactivate energy via the
reactivate alarm.
Better:Better:
If the user releases the activation switch before end of seal, the generator software shall
deactivate energy.
Best:
The device software shall deactivate RF within the 80 millisecond period after a switch release.
The device software shall issue a reactivate alarm within the 500 millisecond period after an early
switch release.
⢠Minimize number of qualifiers by deriving / separating requirements if possible.
⢠Simplify the qualifier as much as possible, requirement does not serve as a detailed design
specification.
51 | 16 February 2012
52. Steps to Improve Requirements Writing
â˘Establish Purpose for Requirement
â˘Delete Superfluous Informationâ˘Delete Superfluous Information
â˘Divide and Redefine for Clarity
â˘Scrub with a small team early & often before formal review
The Theta Axis shall be
capable of 2.10
radians/sec.
52 | 16 February 2012
53. Systems Engineering Resources
1. International Council on Systems Engineering: www.incose.org
2 INCOSE Systems Engineering Handbook v3 2 1 INCOSE 20112. INCOSE Systems Engineering Handbook v3.2.1, INCOSE, 2011.
3. Blanchard BS., Fabrycky WJ. Systems Engineering and Analysis, 5th edition. Prentice
Hall, 2010.
4. Weinberg, G. An Introduction to General Systems Thinking. Dorset House, 2001.
5. ISO/IEC 15288:2008: Systems and Software Engineering â System Life Cycle
Processes.
6. Stevens R., Brook P., Jackson K., Arnold S. Systems Engineering: Coping with
Complexity. Prentice Hall, 1998.
7 Schorsch T The Capability Im Maturity Model (CIMM) U S Air Force CrossTalk7. Schorsch T. The Capability Im-Maturity Model (CIMM), U.S. Air Force. CrossTalk
Magazine, 1996.
8. Telelogic DOORS Get It Right The First Time: Writing Better Requirements. IBM,
2008.
53 | 16 February 2012