Risk Management & FMEA in Safety-Critical DevelopmentPeter Haller25 Nov 2015

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Agenda

1.Risks in safety-critical software projects2.Risk Management Lifecycle3.Failure Mode and Effects Analysis (FMEA)4.Managing risks with codeBeamer5.Live demo: codeBeamer's risk management capabilities

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Intland SoftwareWebinar info

• Live demonstration will be followed by a Q&A session

• Webinar recording will be available at http://intland.com/webinars/

• Sign up for our upcoming webinars:

2 Dec 2015 - Transitioning to Agile in Safety-Critical Device Development

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o Founded in 1998o Headquarters in Stuttgart,

Germanyo Office in Silicon Valley, USAo Our ALM solution includes:

• Requirements Management• Software Development

Management• QA & Test Management• Demand Management • IT Operations (DevOps)

IntroductionIntland Software

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Our Clients

Automotive

High Technology

Defense

Finance

Medical

Other

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• Railway, automotive, medical, avionics, nuclear, etc. industries• Risk of harming human lives: safety & reliability crucial• Standards, regulations, guidances to control risks & process

quality• IEC 61508: functional safety requirements ofElectrical/Electronic/Programmable ElectronicSafety-related Systems

http://intland.com/using-codebeamer-to-achieve-iec-61508-compliance-2/

Risk Management & FMEA in Safety-Critical DevelopmentRisks in safety-critical software projects

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Risk Management & FMEA in Safety-Critical DevelopmentRisk Management Lifecycle

1. Risk Identification2. Classification and Assessment3. Hazard Analysis4. Risk Reduction Plan5. Risk Mitigation Actions6. Documentation and Reporting

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• FMEA: Safety engineering method for failure mode analysis & action plan

• Used in various industries & required by multiple industry standards (for instance, ISO 14971 in medical device development)

• Helps understand the hazards (failure modes) of components and subsystems

• Cause and effects analysis• Supports the early identification of risks

Risk Management & FMEA in Safety-Critical DevelopmentFailure Mode and Effects Analysis (FMEA)

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• Risk trackers• Complete traceability• FMEA Template• Risk Matrix Diagram• Risk management andverification workflows• Documentation andreporting

Risk Management & FMEA in Safety-Critical DevelopmentManaging risks with codeBeamer

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Live demo

Thank you for your attention!Any questions?

Transitioning to Agile in Safety-Critical Device DevelopmentDate: 2 Dec 2015Time: 4 PM (CET) / 10 AM (ET)http://intland.com/webinars-events/