Thursday, April 24, 2014

The Shelves Are Stacked With Manuals

The shelves are stacked with manuals of different kinds and at times collecting more dust than fingerprints. A common purpose of manuals are to serve as a memory bank, a place to find information or as triggers of operational procedures and processes. Just as when purchasing a vehicle, the operator's manual is there for information and should guide to processes and trigger procedures.

Another purpose is that a manual is required for the issuance of a certificate. These types of manuals are the test, or in other words the bar required to pass for issuance of a certificate. This could be an airport certificate, air-operator certificate or other transportation licenses or certificates. Issuance of a license or certificate to an entity or business requires a manual to document regulatory levels. Obviously, the manual is reviewed as test for compliance, just like a person is tested for a pilot license or vehicle operator license. When AOK the license or certificate is issued.
Organizational accountability is not sitting on the fence watching, but an assessment of threats.
There is a saying that the integrity of a person is not measured by a statements, but by results. Operations manuals are the bar to which results an organization is to be measured by and the goal to reach this bar begins at the moment the certificate or license is issued.

Other manuals may be linked to organizational regulatory conformance. When a manual is approved with the issuance of a certificate it is an approval of  applicable regulatory levels at that moment in time. It is an obligation of the operator to discover changes and to maintain regularly compliance in operations.

When a change has been made an organizational review determine applicability.
When contents of controlled manuals are changed, these changes are reviewed by the enterprise for conformance to regulatory requirements and approved in accordance with documented roles and responsibilities. Other reviews may be of process effectiveness, personnel suitability and best practices.

Manuals are tools of documentation for what is required by regulations to obtain a certificate or license, tools to establish processes to configure operational conformance and as a tools when conducting quality assurance of the enterprise.

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Thursday, April 10, 2014

What SMS Is Not

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.

A risk assessment for an exemption request includes mitigation processes.
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.  

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.
Mitigation processes may take on a different face than regular operational processes.

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.

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