References Action

Event Effect / Comments Probability Impact Risk Score Required

The loss of function would only

The Punches on the Two-Way Punch Loss of use of the Two-Way
break off at the handle
The Punch does not fit through its
respective holes in the tabletop
Incorrect hole locations or hole sizes
on the tabletop
Tabletop bending or breaking in half The tabletop would not be
Splinters from the tabletop wood
hurt user
The collecting bin is placed
incorrectly under the funnel
Punch
Loss of use of the Two-Way
Punch
The plugs cannot be removed because it does not do it's
using the tabletop
able to hold the mattress.
Lose functionality
The user is slightly injuried
The plugs fall on the ground
and the user has to manually
pick them up
be related to the hand took
and not the table, so this risk
event received a 6 for impact 2 6 12 Avoid
The loss of function would only
be related to the hand took
and not the table, so this risk
event received a 6 for impact 3 6 18 Mitigate
The final product is useless
intended function. 4 10 40 Mitigate
If the table breaks, the table
would be useless. The team
has designed against this by
using a strong board that can
withstand the load 1 8 8 Accept
The user may slighly bleed, but
no major injury will result from
a splinter 2 5 10 Mitigate
This is an inconvience, but
nothing terrible will happen if
this occurs. The team will place
a tape area under the funnel
as an indicator of where the
bin should be placed 3 1 3 Mitigate

pg 1 of 16
 References Action
Event Effect / Comments Probability Impact Risk Score Required
Plugs get stuck on the inside of the The user must hit on the side
funnel of the funnel to get the stuck The team has chosen a funnel
plugs down slope and material that will
prevent this 2 1 2 Accept
The fabric of the funnel tears The funnel will no longer lead
the plugs into the collecting The funnel is made out of a
bin material which should not rip
easily, and the environment
does not put the funnel in
danger 1 4 8 Accept
The weld at the base of the Leg The teable cannot stand and
Frames breaks cannot be used
If the table canot stand alone,
the the device has lost all
function. However, the weld's
will be strong and should not
pose a large risk of breaking 1 10 10 Accept
The Table improves efficiency of the More waffle mattress are
line more than expected produced in a day, and profit
is increased
n/a 2 10 20 Accept
The new Plug Removal Process is Line workers/users will be
more comfortable for the happier doing their job, and The Team has redesigned the
employees than the old process experience less pain hand tool and table to achieve
this 5 8 45 Exploit
Force required to turn the crank is
too high
Some employees have a
Employee must seek physical diability which is
assistance to adjust table generally associated with less
hindering productivity strength and muscle control 3 7 21 Mitigate

pg 2 of 16
 References Action
Event Effect / Comments Probability Impact Risk Score Required

pg 3 of 16
 References Action
Event Effect / Comments Probability Impact Risk Score Required

pg 4 of 16
 References Action
Event Effect / Comments Probability Impact Risk Score Required

pg 5 of 16
 References Action
Event Effect / Comments Probability Impact Risk Score Required

pg 6 of 16
 References Action
Event Effect / Comments Probability Impact Risk Score Required

pg 7 of 16
 Risk Control Revised Revised Revised
Measure(s) Severity Probability Risk Score

The TempurBEdic team changed the design.

The punches now screw into the handle rather
than be permanently connected. This prevents
the risk of the punches breaking off 6 1 6

The TempurBEdic team has designed the

punches to be of smaller dimensions that the
holes in the table to ensure a seamless fit 6 1 6
The TempurBEdic team has done two tests to
ensure the holes are placed into the final
tabletop board in the correct locations 10 1 10

The team is using a strong board with an

appropriate thickness that should be able to
withstand a large load for long periods of time n/a n/a n/a

The TempurBEdic team will user finished board

or apply a finishing coat, and sand all
holes/edges to prevent splinters from
happening as frequently 5 1 5

Placing the tape under the funnel should

indicate where to place the bin to decrease the
frequency of occurrence 1 1 1

pg 8 of 16
 Risk Control Revised Revised Revised
Measure(s) Severity Probability Risk Score

n/a n/a n/a n/a

n/a n/a n/a n/a

n/a n/a n/a n/a

n/a n/a n/a n/a

The team updated the hand tool to include
three different handle sizes to be more
comfortable for different users 5 10 50

Make the lever longer to minimize required

force. Use a gear with more teeth or greater
pitch. 7 2 14

pg 9 of 16
Risk Control Revised Revised Revised
Measure(s) Severity Probability Risk Score

pg 10 of 16
Risk Control Revised Revised Revised
Measure(s) Severity Probability Risk Score

pg 11 of 16
Risk Control Revised Revised Revised
Measure(s) Severity Probability Risk Score

pg 12 of 16
Risk Control Revised Revised Revised
Measure(s) Severity Probability Risk Score

pg 13 of 16
Risk Control Revised Revised Revised
Measure(s) Severity Probability Risk Score

pg 14 of 16
 NEGATIVE RISK Probability and Impact Matrix

Impact
10 Catastrophic Loss of limb; life-threatening injury
8-9 Critical Severe, long-term injury; potential disability, complete loss of function of the device
Short-term injury or impairment requiring additional medical intervention to correct (e.g.,
6-7 Serious reoperation), device losses some functionality
4-5 Moderate Moderate customer inconvenience; no or minor injury results
2-3 Minor Slight customer inconvenience; little to no effect on product performance, non-vital fault Impact
1 Negligible No or negligible risk to patient 1 2 3 4 5 6 7 8 9 10
5 5 10 15 20 25 30 35 40 45 50

Probability
Probability 4 4 8 12 16 20 24 28 32 36 40
5 Frequent ≥ 1 in 10 3 3 6 9 12 15 18 21 24 27 30
4 Probable < 1 in 10 2 2 4 6 8 10 12 14 16 18 20
3 Occasional < 1 in 50 1 1 2 3 4 5 6 7 8 9 10
2 Remote < 1 in 500
1 Improbable < 1 in 1,000,000 ACCEPTABLE RISK UNACCETABLE RISK
 POSITIVE RISK Probability and Impact Matrix

Impact
10 Life-changing Positively changed the life of user, client, staff, etc.
8-9 Long-term high Made weeks or months great!
6-7 Short-term high Made today a great day!
4-5 Moderate Good outcome
2-3 Minor 'Small win,' enjoyable episode Impact
1 Negligible No or negligible benefit 1 2 3 4 5 6 7 8 9 10
5 5 10 15 20 25 30 35 40 45 50

Probability
Probability - Single Use Instruments 4 4 8 12 16 20 24 28 32 36 40
5 Frequent ≥ 1 in 10 3 3 6 9 12 15 18 21 24 27 30
4 Probable < 1 in 10 2 2 4 6 8 10 12 14 16 18 20
3 Occasional < 1 in 50 1 1 2 3 4 5 6 7 8 9 10
2 Remote < 1 in 500
1 Improbable < 1 in 1,000,000 SHARE/ACCEPT RISK EXPLOIT/ENHANCE RISK