Safety-Critical Software Status Report

Safety-Critical Software: Status Report Authors: Patrick R.H. Place Kyo C. Kang Presented by: Julio Munoz Jorge Favela Therac 25: A Study Case • Radiation Therapy machine • Patients were given massive overdoses of radiation • How much? • Approximately 100 times the intended dose of radiation Requirements Engineering and Safety • Safety critical components of a system must be developed on a particular way • Requirements engineering eliminate errors from –Misunderstanding customer desires –Poorly conceived customer requests • Systems cannot be feasible tested in a live situation • Customer requirements are presented on many forms: natural language, diagrams & mathematics Comments on Software Safety Reliability is Not safety Reliability: “The probability that a system will not fail for a stated length of time” Safety: “The absence of unsafe software conditions” A system may be reliable but unsafe Software Need Not Be Perfect Perfect Software: It does not contain errors. Software Error: A variance between the operation of the software and the user’s concept of how the software should operate. Software Reliability Model • Static Models • Dynamic Models The Rayleigh Model Safe Software Is Secure and Reliable Security depends on reliability Safety depends on… A secure system needs to be reliable, to do not fail at any point. The system-critical components needs to be secure, not altered by external agents. Software Should Not Replace Hardware • Software is flexible and easy to modify. • Hardware maybe quite expensive to modify. • Hardware fails in more predictable ways than software. • Software does not exhibit physical characteristics that maybe observed in the same way as hardware. Hazard Analysis Technique • To check the hazard of the system, there are two aspects – Hazard identification – Hazard analysis Hazard Identification [1] • The Delphi technique – One approach to reaching decision groups. – Member of the group are separated geographically – Basic Approach • The members of the group receive a questionnaire to express their opinion. • A coordinator collect the member’s opinion and send to a expert Hazard Identification [2] • The expert may be agree or disagree explaining any outlying opinion • The group produce a opinion after several rounds. Hazard Identification [3] • Join Application Desing (JAD) – It is an approach to developing detail system definition – The purpose is to reach a decision about a particular topic – People who participate must be skilled and empowered to make decision. – The number of people must be between 6 and 10 Hazard Identification [4] – JAD needs a facilitator • Does not have any interest • Good communicator and diplomatic • Control the group – JAD require a sponsor • Ensure coordination – The ideas own to the group rather than individual – The disadvantage • The coordinator can become a bottleneck Hazard Identification [5] • Hazard and operative analysis – Operate at all stages of the development life cycle – Ensure a systematic evaluation of the functional requirements – two step of analysis • Identify how the system should operate • Determine when a identify condition become safety critical Hazard Identification [6] – The data generates tables • Indicate sequence of operation – Hazard may occur Hazard Analysis [1] • Examine the system and determine lead to a mishap • Two strategies – Inductive techniques • Consider a particular component of the system and attempt to know what is the consequences of the fault will be • Determine “What” system state are possible Hazard Analysis [2] – Deductive techniques • Consider a system failure and then attempt to know the system or component state contribute the system failure • Determine “How” given state occurs Hazard Analysis [2] • Fault Tree Analysis – It is deductive – Determine the cause of an undesirable event – Use connector • and gate: an output occurs if all of the inputs fault occurs • or gate: an output occurs if any of the input fault occur • Basic event: is a basic initiating fault and require no further development Hazard Analysis [3] • Fault Tree Analysis – It is deductive – Determine the cause of an undesirable event – Use connector and gate or gate Basic event Undeveloped event intermediate event Hazard Analysis [4] • Event Tree Analysis – It is inductive technique – Consider the initiating event in the system • Consider all the consequences of that event – Analyzes desirable and undesirable event – It is forwarding-looking • Consider future problem Hazard Analysis [4] • Failure Modes and Effect Analysis – Inductive technique – Intent to anticipate potential failures References • THERAC-25, Computerized Radiation Therapy TROY GALLAGHER http://www.netcomp.monash.edu.au/cpe9001/assets/readings/www_uguelph_ca_~tgallagh_~tgallagh.html • Medical Devices: The Therac 25 Nancy Leveson University of Washington 1995 • CSQE Primer Barbara Frank, Phil Marriot & Chett Warzusen Third Edition 2002 Quality Council of Indiana Questions Presented by: Julio Munoz Jorge Favela

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