Biomedical Engineering Reference
In-Depth Information
Project X - Open Anomalies Severities
80
Catastrophic
Severe Impairment
0
70
60
0
2
1
19
3
3
50
0
0
00 0
4
4
Non-Critical
Minor
No Effect
0
0
40
23
19
1
00
00 00
23
24
0
0
00 00
22
17
1 17
1 1919
0
00
00 0
00
13
21
182314
13
9
88
101 10
1 10
30
0
20
1
171 171 171717
171 171
16
16
10
Not Assigned
0
00
00
Weeks
Figure 5.4-2 Metric chart showing open anomalies sorted by severity.
protocol. If test scripts are written, then a set of de-
velopment guidelines is suggested.
Test development
Requirements analysis and allocating
requirements
Test execution
This section discusses approaches that are used when
executing manual protocol and automated scripts.
Today, it is assumed that a SRS is written. The SRS de-
scribes the behavior and functionality of the software in
the medical device. It should obtain its inputs from the
following sources:
Process improvement
No test process is perfect. There are always ways to
improve the test-development process to do things more
efficiently. Thus, some time should be set aside for
review of the current processes that are in place. If the
test team is large enough, a process team can be created
to address processes and process changes in the test
group. Discussions should occur among test team mem-
bers to determine those processes that worked well and
those that did not.
Derivation of the product specification
Control procedures from the risk and hazard analyses
Regulatory requirements, such as safety-relevant
computing
A large part of the verification and validation effort will
concentrate on proving that these software requirements
are fulfilled. Therefore, the requirements in the SRS
Project X Test Development
50
45
40
35
Original Plan-
Cumulative
30
25
22
20
Accomplished this
month
15
11
10
9
Actual-Cumulative
5
1
00
0
0
Dec-
97
Jan-
98
Feb-
98
Mar-
98
Apr-
98
May-
98
Jun-
98
Jul-
98
Aug-
98
Sep-
98
Oct-
98
Nov-
98
Dec-
98
Jan-
99
Feb-
99
Month
Figure 5.4-3 Monitoring the test-development process.
