PROCESS 2.2.3 CONTROL/MITIGATE SAFETY RISK.

Performance Objective. The organization will design and implement a risk control for
each identified hazard for which there is an unacceptable risk, to reduce risk to acceptable levels.The potential for residual risk and substitute risk will be analyzed before implementing any risk controls.
Design Expectations.
(1) Safety control/mitigation plans will be defined for each hazard with unacceptable risk.
(2) Safety risk controls will be:
             (a) Clearly described,
             (b) Evaluated to ensure that the expectations have been met,
             (c) Ready to be used in their intended operational environment, and documented.
(3) Substitute risk will be evaluated when creating safety risk controls/mitigations.

Controlling Risk.  Process 2.2.3) After hazards and risk are fully understood from the preceding steps, risk controls must be designed and implemented. These may be additional or changed procedures, new supervisory controls, addition of organizational hardware, or software aids, changes to training, additional, or modified equipment, changes to staffing arrangements, or any of a number of other system changes.

Residual and Substitute Risk. Process 2.2.3) Residual risk is the risk remaining after mitigation has been completed. Often this is a multistep process, continuing until risk has been mitigated down to an acceptable level necessary put the system/process into operation (or continue operation). It is seldom possible to entirely eliminate risk, even when highly effective controls are used. After these controls are designed but before the system is placed back on line, an assessment must be made of whether the controls are likely to be effective and/or if they introduce new hazards to the system. The latter condition, introduction of new hazards, is referred to as substitute risk, a situation where the cure is worse than the disease. The loop seen in Figure 2 that returns back to the top of the diagram depicts the use of the preceding systems analysis, hazard identification, risk analysis, and risk assessment processes to determine if the modified system is acceptable.


System Operation. Process 2.2.3) When the controls are acceptable, the system is placed into operation. The next process, SA, uses auditing, analysis, and review systems that are familiar from similar quality management systems. These processes are used to monitor the risk controls to ensure they continue to be implemented as designed and continue to be effective in a changing operational environment.


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