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by design (a design in safety leads to a more robust software design), 2) protective
design measures in which the product will fail safe and/or alarms when risk presents,
3) protective measures (e.g., input/output mistake proofing) and/or inherent correction
test capabilities, 4) information for safety such as instructions for use and training.
15.6
POSTRELEASE CONTROL
Information gained about the software or similar software in the postrelease phase
(see beyond stage 8 in the software life cycle shown in Chapter 8) performance should
be reviewed and evaluated for possible relevance to safety for the following: 1) if
new or previously unrecognized hazards or causes are present, 2) if the estimated risk
resulting from a hazard is no longer acceptable, and 3) if the original assessment of
risk is invalidated. If further action is necessary, then a Six Sigma project should be
initiated to investigate the problem.
15.7 SOFTWARE RISK MANAGEMENT ROLES AND
RESPONSIBILITIES
Table 15.5 outlines the responsibility for the deliverables created by the risk man-
agement process within the DFSS road map. RASCI stands for R
=
Responsible, A
=
=
=
=
Approver; S
can be Supportive, C
has to be Consulted, and I
has to be
Informed.
15.8
CONCLUSION
The most significant aspects of building risk management into the flow of the software
development process are to imbed the tradeoff concept of the risk-versus-benefit
analysis as part of the design and development process.
The DFSS methodology helps in making data decision based and allows for logical
tradeoffs and quantifiable risk-versus-benefits analysis. DFSS methodology provides
traceability in which relationships among hazards, requirements, and verification and
validation activities are identified and linked.
Risk management itself is a process centered on understanding risks and evaluating
their acceptability, reducing any risks to as low as possible, and then evaluating
residual risk and overall software safety against the benefits derived. Integrating risk
management into the design and development process requires keeping risk issues at
the forefront of the entire process from design planning to verification and validation
testing. In this way, risk management becomes part of the software development
process, evolves with the design, and provides a framework for decision making.
The software Design For Six Sigma process—the subject of this topic—is used as
a risk management toolkit in which it drives the data-driven approach behind decision
making. It is well known that if we make decisions based on factual data, then the
chances of negative consequences are reduced.
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