1. Test
Case
Tags
6 Active Hazard Analysis
SW Usability MDD 7.2 Contamination (via contaminants and residues) to persons involved in the transport, storage and use of the device and
to the patients.
Affected Users & Location of use
No Yes Customer (adult, children, infant), Store personnel/store use
Hazard Description: Hazard Scenario Potential Harm: Cause:
Cart device RF radiation too high 1. Interference with pacemaker or other medical
device causing malfunction and loss of critical
care
Possible heart attacks or other medical issues Excessive RF energy and of particular frequency to cause pacemaker
or other device carried by customer to malfunction.
Pre-Mitigation Initial Risk Assessment
Probability of Occurrence (HW) Severity Vulnerability (SW) Susceptibility (SW) RPN
Probable Critical (S3) NN/A/A
N/A
Undesirable;
Objectionable
Rationale: Rationale: N/A
N/A
High radiation can interfere with electronic
devices
Potential for heart attacks can be critical
Mitigation(s) Required
Mitigations (Narrow) Ongoing Provisions 1 Requirement Ref 1 V&V Ref 1
1. Designed for low power levels per standard xxxx
2. Frequency band set per standard xxxx
MFG HI-POT test SFR-089 SVTC-080
Designed to meet 60601-2 MFG Inspection SFR-234 SVTC-009
Designed to meet 60601-1-3 MFG Inspection SFR-056 SVTC-073
Post-Mitigation Risk Assessment
Probability of Occurrence Severity N/A N/A RPN
Improbable Critical (S3)
AcceptableRationale: Rationale: N/A
N/A
Device tested to accepted standard Same as Initial Severity
Risk Benefit Analysis Not Required
Test
Cases
Requirements
Document
(s)
SFR:130The
return
valve
time
shall
exclude
startup
delays.
longer
than
40
seconds.
[SFR-‐081]
SFR:128The
system
shall
be
locked
out
of
normal
operation
after
7
days
and
24
hours
without
going
through
the
weekly
cleaning
cycle.
Lockout
shall
bring
user
to
a
screen
with
a
"Check"
button
which
will
start
the
weekly
clean
process.
The
7
day
timer
shall
bereset
any
time
the
cleaning
cycle
is
executed.
Lockout
shall
not
occur
during
drink
making.
[SFR-‐126]
SFR:129After
7
days
and
zero
hours
the
cleaning
reminder
screen
shall
appear
every
hour
until
lockout.
The
"X"
button
shall
return
to
the
configured
default
screen
and
the
"Check"
button
shall
take
the
user
to
the
weekly
cleaning
function
screen.
This
reminder
screen
shall
not
appear
during
drink
making.
[SFR-‐127]
SVTC:003The
purpose
of
this
test
is
to
verify
the
off
state
of
the
system{Test
Method=Whtbox}
[SFR:124]
[SFR:128]
Items/Equipment Needed for this Test
Oscilloscope
Test Setup/Notes Test Steps
Step
Tag
Action
Expected
Result
1
SFR-‐124
Power-‐on
unit
1.
Verify
no
momentary
blender
motor
actions
2.
Verify
no
momentary
5.
Verify
display
powers
up
and
goes
to
top
category
screen
2
SFR-‐124
Start
a
drink
and
proceed
to
the
blending
operation.
In
the
middle
of
blending,
power
unit
off
then
power
unit
back
on
1.
Verify
blender
returns
to
home
position
2.
Verify
no
momentary
product
pumps
enabled
3.
Verify
no
momentary
water
is
enabled
4.
Verify
no
momentary
air
is
enabled
5.
Verify
display
powers
up
and
goes
to
top
category
screen
Base
Temperature
Test
3
SFR-‐128
With
product
inventory
such
that
no
bags
are
empty
or
expired
set
base
temperature
to
above
44°F,
chute
temperature
to
below
44°F
and
power
cycle
unit.
1.
Verify
“ERROR
HIGH
PRODUCT
TEMPERATURE
ALL
FLAVORS
EXPIRED
–
CHECK
DOOR”
is
displayed
2.
Verify
check
button
present
4
SFR-‐128
Press
check
Verify
display
goes
to
default
screen
5
SFR-‐128
Navigate
to
inventory
screen
Verify
all
products
are
expired
SFR:124The
cycle
time
for
making
a
single
stage
drink
including
the
time
for
mixing
excluding
cleaning
shall
be
no
longer
than
40
seconds.
[SFR-‐081]
SFR:128The
system
shall
be
locked
out
of
normal
operation
after
7
days
and
24
hours
without
going
through
the
weekly
cleaning
cycle.
Lockout
shall
bring
user
to
a
screen
with
a
"Check"
button
which
will
start
the
weekly
clean
process.
The
7
day
timer
shall
be
reset
any
time
the
cleaning
cycle
is
executed.
Lockout
shall
not
occur
during
drink
making.
[SFR-‐126]
SFR:129After
7
days
and
zero
hours
the
cleaning
reminder
screen
shall
appear
every
hour
until
lockout.
The
"X"
button
shall
return
to
the
configured
default
screen
and
the
"Check"
button
shall
take
the
user
to
the
weekly
cleaning
function
screen.
This
reminder
screen
shall
not
appear
during
drink
making.
[SFR-‐127]
Traceability Matrix
Requirement
Tag
Top Level Requirement Text
Test Case
Tag
Test Case Requirement Document Title Test Document Title Test Method Test Results
SFR:002
If the AIF subsystem receives the VALVE REQUEST message from the
MIB with an SID for this AIF selecting the "drain" valve and requesting
"open valve", the AIF subsystem shall change to the "valve opening" state
and drive the drain valve actuator in the forward direction and report]
SVTC:003
The purpose of this test is to verify the proper AIF
responses to valve Drain/Return valve
Open/Close request commands.
System Functional Requirements AIF Functional Test Protocol Black-box PASSED
SFR:003
If the AIF subsystem is in the AIF_DRAIN_OPENING state (has reported a
status message of drain valve opening) and detects that the drain valve
position sensor is greater than <458 counts- fixed counts>, the
SVTC:004
The purpose of this test is to verify the proper AIF
responses to valve Drain/Return valve
Open/Close request commands.
System Functional Requirements AIF Functional Test Protocol White-box PASSED
HAZ:006
If the AIF subsystem is in the AIF_DRAIN_CLOSING state (has reported a
status message of drain valve closing) and less than <109 counts>, the AIF
subsystem shall change to the AIF_DRAIN_CLOSED state
SVTC:005
The purpose of this test is to verify the proper AIF
responses to valve Drain/Return valve
Open/Close request commands.
System Functional Requirements AIF Functional Test Protocol Inspection PASSED
FMEA:001
If the AIF subsystem is in the AIF_RETURN_OPENING state (has reported
a status message of return valve opening) and detects that the return valve
position sensor is greater than <458- fixed counts>, the AIF _OPEN state
and report a return valve status message of valve open.
SVTC:006
The purpose of this test is to verify the proper AIF
responses to valve Drain/Return valve
Open/Close request commands.
System Functional Requirements AIF Functional Test Protocol Inspection PASSED
SVTC:001
The
purpose
of
this
test
is
to
verify
the
power-‐up
state
of
the
system
{Test
Method=White-‐box}
[SFR:124]
[SFR:128]
Items/Equipment Needed for this Test
Oscilloscope
Test Setup/Notes Test Steps
Step
Tag
Action
Expected
Result
1
SFR-‐124
Power-‐on
unit
1.
Verify
no
momentary
blender
motor
actions
2.
Verify
no
momentary
5.
Verify
display
powers
up
and
goes
to
top
category
screen
2
SFR-‐124
Start
a
drink
and
proceed
to
the
blending
operation.
In
the
middle
of
blending,
power
unit
off
then
power
unit
back
on
1.
Verify
blender
returns
to
home
position
2.
Verify
no
momentary
product
pumps
enabled
3.
Verify
no
momentary
water
is
enabled
4.
Verify
no
momentary
air
is
enabled
5.
Verify
display
powers
up
and
goes
to
top
category
screen
Base
Temperature
Test
3
SFR-‐128
With
product
inventory
such
that
no
bags
are
empty
or
expired
set
base
temperature
to
above
44°F,
chute
temperature
to
below
44°F
and
power
cycle
unit.
1.
Verify
“ERROR
HIGH
PRODUCT
TEMPERATURE
ALL
FLAVORS
EXPIRED
–
CHECK
DOOR”
is
displayed
2.
Verify
check
button
present
4
SFR-‐128
Press
check
Verify
display
goes
to
default
screen
5
SFR-‐128
Navigate
to
inventory
screen
Verify
all
products
are
expired
Requirement
Tags
System FMEA
Item Function
Potential
Failure
Mode(s)
Potential
Effect(s)
of Failure
Sev
Potential Cause(s)/
Mechanism(s) of
Failure
Prob
Current Preventions
Requirement
Tag
Current Detections
Det
RPN
JIB Contains
fresh oil
Leaking
container
Leaks oil
onto floor
3
Punctured container,
torn or failed seams
4
FMEA:001Mount
JIB/BIB to minimize
potential for leaking
container [FMEA-001]
SFR:010
Detect leaking
container in
storeroom
10 120
Master Requirements data base
Tag Requirement
Category
Requirement Risk
(Y/N)
Verification
Method
Test Case # Status
Deleted
Status
added
Destination
Document
CCR:022 Auto filter
If the vat is in the Auto Filter Requested state and the
vat temperature is less than 300°F, then the vat shall
raise the oil temperature to 300°F or greater
N Black-box SVTC-053
N Y
FRS-010
(UI)
CCR:023 Auto filter
If the Cooker is in the Auto Filter Requested state, N White--box SVTC-053
N N
FRS-010
(UI)
CCR:041 Rack Function
In a rack system, if the rack is not down from the time
the user presses the product button, in 60
N Inspection SVTC-114
N Y
FRS-010
(UI)
CCR:042 Rack Function
When in cool mode, if the user presses and holds the
rack down buttons until the rack is down, the
N Black-box SVTC-114
Y Y
FRS-010
(UI)
CCR:043 Rack Function
After selecting a product, when the user presses and
holds both rack down buttons until the rack is
N Wht box SVTC-114
Y
FRS-010
(UI)
Quick
Data
sorting
Process
Overview
Diagram
![Test
Case
Tags
6 Active Hazard Analysis
SW Usability MDD 7.2 Contamination (via contaminants and residues) to persons involved in the transport, storage and use of the device and
to the patients.
Affected Users & Location of use
No Yes Customer (adult, children, infant), Store personnel/store use
Hazard Description: Hazard Scenario Potential Harm: Cause:
Cart device RF radiation too high 1. Interference with pacemaker or other medical
device causing malfunction and loss of critical
care
Possible heart attacks or other medical issues Excessive RF energy and of particular frequency to cause pacemaker
or other device carried by customer to malfunction.
Pre-Mitigation Initial Risk Assessment
Probability of Occurrence (HW) Severity Vulnerability (SW) Susceptibility (SW) RPN
Probable Critical (S3) NN/A/A
N/A
Undesirable;
Objectionable
Rationale: Rationale: N/A
N/A
High radiation can interfere with electronic
devices
Potential for heart attacks can be critical
Mitigation(s) Required
Mitigations (Narrow) Ongoing Provisions 1 Requirement Ref 1 V&V Ref 1
1. Designed for low power levels per standard xxxx
2. Frequency band set per standard xxxx
MFG HI-POT test SFR-089 SVTC-080
Designed to meet 60601-2 MFG Inspection SFR-234 SVTC-009
Designed to meet 60601-1-3 MFG Inspection SFR-056 SVTC-073
Post-Mitigation Risk Assessment
Probability of Occurrence Severity N/A N/A RPN
Improbable Critical (S3)
AcceptableRationale: Rationale: N/A
N/A
Device tested to accepted standard Same as Initial Severity
Risk Benefit Analysis Not Required
Test
Cases
Requirements
Document
(s)
SFR:130The
return
valve
time
shall
exclude
startup
delays.
longer
than
40
seconds.
[SFR-‐081]
SFR:128The
system
shall
be
locked
out
of
normal
operation
after
7
days
and
24
hours
without
going
through
the
weekly
cleaning
cycle.
Lockout
shall
bring
user
to
a
screen
with
a
"Check"
button
which
will
start
the
weekly
clean
process.
The
7
day
timer
shall
bereset
any
time
the
cleaning
cycle
is
executed.
Lockout
shall
not
occur
during
drink
making.
[SFR-‐126]
SFR:129After
7
days
and
zero
hours
the
cleaning
reminder
screen
shall
appear
every
hour
until
lockout.
The
"X"
button
shall
return
to
the
configured
default
screen
and
the
"Check"
button
shall
take
the
user
to
the
weekly
cleaning
function
screen.
This
reminder
screen
shall
not
appear
during
drink
making.
[SFR-‐127]
SVTC:003The
purpose
of
this
test
is
to
verify
the
off
state
of
the
system{Test
Method=Whtbox}
[SFR:124]
[SFR:128]
Items/Equipment Needed for this Test
Oscilloscope
Test Setup/Notes Test Steps
Step
Tag
Action
Expected
Result
1
SFR-‐124
Power-‐on
unit
1.
Verify
no
momentary
blender
motor
actions
2.
Verify
no
momentary
5.
Verify
display
powers
up
and
goes
to
top
category
screen
2
SFR-‐124
Start
a
drink
and
proceed
to
the
blending
operation.
In
the
middle
of
blending,
power
unit
off
then
power
unit
back
on
1.
Verify
blender
returns
to
home
position
2.
Verify
no
momentary
product
pumps
enabled
3.
Verify
no
momentary
water
is
enabled
4.
Verify
no
momentary
air
is
enabled
5.
Verify
display
powers
up
and
goes
to
top
category
screen
Base
Temperature
Test
3
SFR-‐128
With
product
inventory
such
that
no
bags
are
empty
or
expired
set
base
temperature
to
above
44°F,
chute
temperature
to
below
44°F
and
power
cycle
unit.
1.
Verify
“ERROR
HIGH
PRODUCT
TEMPERATURE
ALL
FLAVORS
EXPIRED
–
CHECK
DOOR”
is
displayed
2.
Verify
check
button
present
4
SFR-‐128
Press
check
Verify
display
goes
to
default
screen
5
SFR-‐128
Navigate
to
inventory
screen
Verify
all
products
are
expired
SFR:124The
cycle
time
for
making
a
single
stage
drink
including
the
time
for
mixing
excluding
cleaning
shall
be
no
longer
than
40
seconds.
[SFR-‐081]
SFR:128The
system
shall
be
locked
out
of
normal
operation
after
7
days
and
24
hours
without
going
through
the
weekly
cleaning
cycle.
Lockout
shall
bring
user
to
a
screen
with
a
"Check"
button
which
will
start
the
weekly
clean
process.
The
7
day
timer
shall
be
reset
any
time
the
cleaning
cycle
is
executed.
Lockout
shall
not
occur
during
drink
making.
[SFR-‐126]
SFR:129After
7
days
and
zero
hours
the
cleaning
reminder
screen
shall
appear
every
hour
until
lockout.
The
"X"
button
shall
return
to
the
configured
default
screen
and
the
"Check"
button
shall
take
the
user
to
the
weekly
cleaning
function
screen.
This
reminder
screen
shall
not
appear
during
drink
making.
[SFR-‐127]
Traceability Matrix
Requirement
Tag
Top Level Requirement Text
Test Case
Tag
Test Case Requirement Document Title Test Document Title Test Method Test Results
SFR:002
If the AIF subsystem receives the VALVE REQUEST message from the
MIB with an SID for this AIF selecting the "drain" valve and requesting
"open valve", the AIF subsystem shall change to the "valve opening" state
and drive the drain valve actuator in the forward direction and report]
SVTC:003
The purpose of this test is to verify the proper AIF
responses to valve Drain/Return valve
Open/Close request commands.
System Functional Requirements AIF Functional Test Protocol Black-box PASSED
SFR:003
If the AIF subsystem is in the AIF_DRAIN_OPENING state (has reported a
status message of drain valve opening) and detects that the drain valve
position sensor is greater than <458 counts- fixed counts>, the
SVTC:004
The purpose of this test is to verify the proper AIF
responses to valve Drain/Return valve
Open/Close request commands.
System Functional Requirements AIF Functional Test Protocol White-box PASSED
HAZ:006
If the AIF subsystem is in the AIF_DRAIN_CLOSING state (has reported a
status message of drain valve closing) and less than <109 counts>, the AIF
subsystem shall change to the AIF_DRAIN_CLOSED state
SVTC:005
The purpose of this test is to verify the proper AIF
responses to valve Drain/Return valve
Open/Close request commands.
System Functional Requirements AIF Functional Test Protocol Inspection PASSED
FMEA:001
If the AIF subsystem is in the AIF_RETURN_OPENING state (has reported
a status message of return valve opening) and detects that the return valve
position sensor is greater than <458- fixed counts>, the AIF _OPEN state
and report a return valve status message of valve open.
SVTC:006
The purpose of this test is to verify the proper AIF
responses to valve Drain/Return valve
Open/Close request commands.
System Functional Requirements AIF Functional Test Protocol Inspection PASSED
SVTC:001
The
purpose
of
this
test
is
to
verify
the
power-‐up
state
of
the
system
{Test
Method=White-‐box}
[SFR:124]
[SFR:128]
Items/Equipment Needed for this Test
Oscilloscope
Test Setup/Notes Test Steps
Step
Tag
Action
Expected
Result
1
SFR-‐124
Power-‐on
unit
1.
Verify
no
momentary
blender
motor
actions
2.
Verify
no
momentary
5.
Verify
display
powers
up
and
goes
to
top
category
screen
2
SFR-‐124
Start
a
drink
and
proceed
to
the
blending
operation.
In
the
middle
of
blending,
power
unit
off
then
power
unit
back
on
1.
Verify
blender
returns
to
home
position
2.
Verify
no
momentary
product
pumps
enabled
3.
Verify
no
momentary
water
is
enabled
4.
Verify
no
momentary
air
is
enabled
5.
Verify
display
powers
up
and
goes
to
top
category
screen
Base
Temperature
Test
3
SFR-‐128
With
product
inventory
such
that
no
bags
are
empty
or
expired
set
base
temperature
to
above
44°F,
chute
temperature
to
below
44°F
and
power
cycle
unit.
1.
Verify
“ERROR
HIGH
PRODUCT
TEMPERATURE
ALL
FLAVORS
EXPIRED
–
CHECK
DOOR”
is
displayed
2.
Verify
check
button
present
4
SFR-‐128
Press
check
Verify
display
goes
to
default
screen
5
SFR-‐128
Navigate
to
inventory
screen
Verify
all
products
are
expired
Requirement
Tags
System FMEA
Item Function
Potential
Failure
Mode(s)
Potential
Effect(s)
of Failure
Sev
Potential Cause(s)/
Mechanism(s) of
Failure
Prob
Current Preventions
Requirement
Tag
Current Detections
Det
RPN
JIB Contains
fresh oil
Leaking
container
Leaks oil
onto floor
3
Punctured container,
torn or failed seams
4
FMEA:001Mount
JIB/BIB to minimize
potential for leaking
container [FMEA-001]
SFR:010
Detect leaking
container in
storeroom
10 120
Master Requirements data base
Tag Requirement
Category
Requirement Risk
(Y/N)
Verification
Method
Test Case # Status
Deleted
Status
added
Destination
Document
CCR:022 Auto filter
If the vat is in the Auto Filter Requested state and the
vat temperature is less than 300°F, then the vat shall
raise the oil temperature to 300°F or greater
N Black-box SVTC-053
N Y
FRS-010
(UI)
CCR:023 Auto filter
If the Cooker is in the Auto Filter Requested state, N White--box SVTC-053
N N
FRS-010
(UI)
CCR:041 Rack Function
In a rack system, if the rack is not down from the time
the user presses the product button, in 60
N Inspection SVTC-114
N Y
FRS-010
(UI)
CCR:042 Rack Function
When in cool mode, if the user presses and holds the
rack down buttons until the rack is down, the
N Black-box SVTC-114
Y Y
FRS-010
(UI)
CCR:043 Rack Function
After selecting a product, when the user presses and
holds both rack down buttons until the rack is
N Wht box SVTC-114
Y
FRS-010
(UI)
Quick
Data
sorting
Process
Overview
Diagram](https://image.slidesharecdn.com/42ef8888-2744-481c-a261-7f21f6e4ceef-150212092231-conversion-gate02/85/Requirements_and_Testing_Diagram_Process2-1-320.jpg)
