No.

Hazard

Unique ID
for this
hazardous
situation

Typically in
the form of
hazard from
Table E.1 of
EN
ISO14971:20
12.
e.g. Incorrect
measuremen
t-

Sequence of
Events
Step bystep
sequence
that can
expose the
hazard

Hazardous
Situation
The situation
that results
from the
sequence of
events

Harm

Sev

Prob

Risk Index

Risk Control

The possible
harm specific
to the
hazardous
situation

The severity
of the hard

The
probability
of the
hazardous
situation
arising and
resulting in
the harm

The result of
our
standardised
risk
evaluation
and ranges
from 1 to 4

The risk
control
measure (if
one is
required)

Control
Reference
The
requirement
specification
reference
that
implements
the risk
control

Risk Index - Broadly speaking (1 = Acceptable,2= Tolerable if as low as possible, 3 = Undesirable and subject to specific risk/benefit analysis, 4 = Unacceptable)

Controlled
Prob
The
probability
of the
hazardous
situation
arising and
resulting in
the harm
after the
application
of the risk
control

Controlled
Risk Index
The result of
our
standardised
risk
evaluation
and ranges
from 1 to 4

Comment
Commentary
on why we
have arrived
at this
conclusion
but not
specifically a
risk control
e.g. field
data