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VALIDATION

VALIDATION PHASES:

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1.     Validation
of Design:  Validating each step of
design process and design methods of the system, such that to reduce the risk and
damage caused.

 

2.     Validation
of Code:
Validating each statements, syntax and conditions in the code, we should check
our code is working as per the design and to avoid dead lock loops and
exceptions occurred and to minimize the risk and damaged caused. 

 

3.     Run-time
Validation: Validating the system during run time in order to check each state
of the system whether it is in safe sate or unsafe state.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

RISK
ANALYSIS

RISKS OF INSULIN PUMP:

1.      Overdose
of insulin due to service failure.

2.      Underdose
of insulin due to service failure.

3.      Failure
in power system (Battery).

4.      Failure
of interface between medical equipment and electric equipment.

5.      Poor
connection between sensors and actuators.

6.      Physical
damage of sensors and actuators.

7.      Damage
of organs in human body because of hardware equipment introduced in body.

8.      Biological
reactions between hardware equipment and acids produced by body.

RISKS OF SOFTWARE:

Algorithm Error:

          Abnormal
behaviour of algorithm is undetectable when it goes to infinite loop.

         

Calculation or Arithmetic Error:

Due to
the overflow and underflow flags there may be error while calculating the
dosage and modelling part, it may cause overdose or underdose.

CLASSIFICATION OF RISK:

The risk is classified by the measuring consequences of the damage
happened.

1.      Critical:  Risk which leads to the heavy damage like
dead of human being is considered as Critical. The consequences of the risk is
very high, which is not acceptable. The red coloured region in the figure is
critical region, which is not acceptable.

2.      Medium:
Risk which leads to the damage, but which have beneficial advantages, these are
come under category of Medium. The consequences of the risk are high but these
can be considered because of its advantages. The yellow coloured region in the
figure is medium region. We should always try to reduce the risk by keeping its
advantages remaining same.

3.      Low:
Risk which is acceptable, because the consequences of the risk are very small.

TOLERANCE LEVEL:

1.      The
tolerance level of critical risk is very low.

2.      The
tolerance level of medium risk is medium.

3.      The
tolerance level of low risk is very high.

Figure:

ANALYSIS REPORT OF OBSERVED RISKS:

S. No

Observed
Risk

Probability

Severity

Risk Category

Acceptability

1.

Overdose
of insulin

Medium

High

High

Intolerable

2.

Underdose
of insulin

Medium

Low

Low

Acceptable

3.

Failure
in power system

High

Low

Low

Acceptable

4.

Interface
Issue

High

High

High

Intolerable

5.

Poor
connection between sensors and actuators

Low

Low

Medium

Partially Acceptable

6.

Physical
damage of system inside the body.

Medium

Medium

Medium

Partially Acceptable

7.

Damage
of organs by equipment.

Low

High

Medium

Partially Acceptable

8.

Biological
reactions between equipment and acids produced by body.

Low

Low

Low

Acceptable

 

ASSESSMENTS OF RISK REDUCTION:

1.      The main
aim of risk reduction assessment is to specify the how the risk is managed to
ensure risk is nor arise again.

Strategies of Risk reduction:

1.      To
provide self-resistance to occurrence of risk.

2.      Detection
and avoiding the risk.

3.      Limiting
the damage caused by risk.

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