VALIDATIONVALIDATION PHASES:1. Validationof Design: Validating each step ofdesign process and design methods of the system, such that to reduce the risk anddamage caused. 2. Validationof Code:Validating each statements, syntax and conditions in the code, we should checkour code is working as per the design and to avoid dead lock loops andexceptions occurred and to minimize the risk and damaged caused. 3. Run-timeValidation: Validating the system during run time in order to check each stateof the system whether it is in safe sate or unsafe state. RISKANALYSISRISKS OF INSULIN PUMP:1.
Overdoseof insulin due to service failure.2. Underdoseof insulin due to service failure.
3. Failurein power system (Battery).4. Failureof interface between medical equipment and electric equipment.5. Poorconnection between sensors and actuators.
6. Physicaldamage of sensors and actuators. 7. Damageof organs in human body because of hardware equipment introduced in body.8. Biologicalreactions between hardware equipment and acids produced by body.RISKS OF SOFTWARE:Algorithm Error: Abnormalbehaviour of algorithm is undetectable when it goes to infinite loop. Calculation or Arithmetic Error:Due tothe overflow and underflow flags there may be error while calculating thedosage and modelling part, it may cause overdose or underdose.
CLASSIFICATION OF RISK:The risk is classified by the measuring consequences of the damagehappened.1. Critical: Risk which leads to the heavy damage likedead of human being is considered as Critical.
The consequences of the risk isvery high, which is not acceptable. The red coloured region in the figure iscritical region, which is not acceptable. 2. Medium:Risk which leads to the damage, but which have beneficial advantages, these arecome under category of Medium. The consequences of the risk are high but thesecan be considered because of its advantages. The yellow coloured region in thefigure is medium region. We should always try to reduce the risk by keeping itsadvantages remaining same. 3.
Low:Risk which is acceptable, because the consequences of the risk are very small.TOLERANCE LEVEL:1. Thetolerance level of critical risk is very low.2. Thetolerance level of medium risk is medium.3. Thetolerance 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 mainaim of risk reduction assessment is to specify the how the risk is managed toensure risk is nor arise again.Strategies of Risk reduction:1. Toprovide self-resistance to occurrence of risk.2. Detectionand avoiding the risk.
3. Limitingthe damage caused by risk.