NOTE: This post is from one of our frequent contributors to this blog, "Birdseye59604."
It
has been said that a Safety Management System, (SMS), is self-regulating of
aviation. SMS may be lot of things, but self-regulating is not one of them. SMS
is self-management, and a tool for an enterprise to manage the day to day
operation, to plan for the future and to analyze processes applied in the past for
further improvement of operational safety.
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A
risk assessment for an exemption request includes mitigation processes.
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An
enterprise is managing safety by risk assessments and applying mitigation
processes. It may be possible to apply for regulatory exemptions. However, with
an exemption an enterprise still conform to regulatory compliance. When an enterprise
prepares an exemption application, they are developing mitigation plans and conducting
risk assessments to justify their intent. Operating with an exception could
cause more strain on the operation than anticipated. It becomes a significant
factor what choice of data is entered into the risk assessments for mitigation.
Other data than data from the enterprise requesting the exception is
non-reliable data.
"SMS is self-management..."
Before
an exception request is considered, an enterprise should apply data collected
to make a self-assessment of processes to conform to regulatory requirements. Data
from their pre-exemption operational processes should be collected and analyzed
in a Statistical Process Control, (SPC), environment. If there is a finding that
a process is not in control, and gives unexpected results, the process should
be changed and tested again before an exemption application is considered.
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Mitigation processes may take on a
different face than regular operational processes.
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Data
collected of exception self-testing over a period of time may be applied as
justification. Depending on the complexity of tests, it could be a week, a
month or a year of testing before there is enough data to establish a process
that conform to regulatory requirements. Data collected is then entered into a database
and analyzed for effectiveness, and if the
process is within acceptable control limits.
A
request for an exemption may be executed after data has been analyzed and found
to be within acceptable tolerable limits and the enterprise has established that they have processes in
place to conform to regulatory requirements. An exemption is application of
mitigation processes to be regulatory compliant, or meet the conditions of the
exemption, when operational conditions
in one or more areas are less than favorable. SMS is not a self-regulating tool
to transfer responsibility, but an exceptional tool of accountability in risk
acceptance management.
BirdsEye59604
Great point! SMS is not Self regulation it is Self Management. Regulation compliance still falls on the regulator, you must manage your System in order to make sure Your System operates within regulatory compliance. The Regulator simply assess whether your system is "Self-Healing" and effective.
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