Abstract
Cambridge Consultants has been developing systems and products, in a wide variety of industries, using a broad spectrum of technologies, for over 35 years. The material in this tutorial is based on our practical experience of managing development projects in industries such as transport, communications and healthcare. We will concentrate on the issues that we, and our clients, have found to cause most problems and will illustrate these issues with case studies from our experience. These will demonstrate a ‘mid-lever’ of integrity — in our experience this is representative of the vast majority of real systems.
The tutorial will include discussion of approaches to solving the following problems:
-
How do you find out what standards and regulations are relevant?
-
How do you make trade-offs between different possible design solutions?
-
How do you move from identified hazards to fixing an integrity level for the software development?
-
How do you choose tools that are technically appropriate and how do you justify that they are fit for their purpose?
-
How do you build the team which has the right mixture of skill and experience, and justify its competencies?
-
How do you manage the pressures as things change? Is it true to say you never make trade-offs which affect safety?
-
How do you carry out audits of your own work and how do you handle external auditors?
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
Belbin RM. “Management teams: why they succeed or fail”, Heinemann, 1981
BS EN 60950:1992 “Specification for safety of information technology equipment, including electrical business equipment”, BSI, 1992
BS EN 60601–1-1:1993 “Medical electrical equipment. General requirements for safety. Collateral standard. Safety requirements for medical electrical systems” BSI, 1993
BS EN ISO 9001:1994 “Quality systems. Model for quality assurance in design, development, production, installation and servicing”, BSI, 1994
TS l:1995 “TickIT Guide”, BSI, 1995
BS EN 60601–1-4:1997 “Medical electrical equipment. General requirements for safety. Collateral standard. General requirements for programmable electrical medical systems”, BSI, 1996
Draft prEN 1441 “Medical devices—risk analysis”, CEN, 1994
Chudleigh M. “Hazard Analysis using HAZOP: A Case Study” In: Gorski E (ed) Proceedings of the 12th International Conference on Computer Safety, Reliability and Security, 1993 (Safecomp’93) pp 99–108
“A Guide to Hazard and Operability Studies”, Chemical Industries Association, 1987
“Devices for Orphan Diseases”, FDA statement T96–47, 27 June 1996
IEC 513 “Fundamental aspects of safety standards for medical electrical equipment”, second edition, IEC, 1994 Section 8
IEC 300–3-9: 1995 “Risk management Part 3. Guide to risk analysis of technological systems” (BS 8444:Part 3:1996), IEC 1995
Draft IEC 1508 Part 1 “Functional safety: safety related systems, Part 1 General requirements” IEC, 1995
Draft IEC 1508 Part 5 “Functional safety: safety related systems, Part 5 Guidelines on the application of Part 1”, IEC, 1995
ISO 9000–3:1991 “Quality management and quality assurance standards—Part 3: Guidelines for the application of ISO 9001 to the development, supply and maintenance of software”, ISO, 1991
Jones-Lee MW, Loomes G. “Measuring the benefits of transport safety”, Proceedings of the Third Safety-critical Systems Symposium, Brighton, Springer-Verlag London, 1995
Leveson NG. “Safeware: system safety and computers”, Addison-Wesley, 1995, p 358–436
Ministry of Defence: Defence Standard 00–56 (Part 2)/Issue 2 DRAFT “Safety management requirements for defence systems containing programmable electronics” MOD, 1991
Redmill F, Chudleigh M, Catmur J. “Principles underlying a guideline for applying HAZOP to programmable electronic systems”, Reliability Engineering and System Safety 55, 1997 pp 283–293
RTCA/DO-178B “Software considerations in airborne systems and equipment certification”, RTCA Inc., 1992
Sandman PM. “Risk communication: facing public outrage” EPA Journal, vol 13, 1987, pp 21-
Segal M. “Is It Worth the Worry? Determining Risk”, FDA Consumer articles 06/01/1990
Shaw D. “The measurement of risk: community measures vs scientific measures”, The Risks Digest 17.71, 1996
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 1998 Springer-Verlag London Limited
About this paper
Cite this paper
Lee, C., Garnsworthy, J., Chudleigh, M., Bishop, D. (1998). Issues in Managing a Safety-Critical System Development Project. In: Redmill, F., Anderson, T. (eds) Industrial Perspectives of Safety-critical Systems. Springer, London. https://doi.org/10.1007/978-1-4471-1534-2_1
Download citation
DOI: https://doi.org/10.1007/978-1-4471-1534-2_1
Publisher Name: Springer, London
Print ISBN: 978-3-540-76189-1
Online ISBN: 978-1-4471-1534-2
eBook Packages: Springer Book Archive