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impacting the complete product life cycle. The critical information resulting from a safety risk
management process can thereby be effectively communicated in an objective and unbiased manner to
decisionmakers, and from decisionmakers to the public. All decisionmaking authorities within the FAA
shall maintain safety risk management expertise appropriate to their operations, and shall perform and
document the safety risk management process prior to issuing the high-consequence decision. The choice
of methodologies to support risk management efforts remains the responsibility of each program office. The
decisionmaking authority shall determine the documentation format. The approach to safety risk
management is composed of the following steps:
a. Plan. A case-specific plan for risk analysis and risk assessment shall be predetermined in
adequate detail for appropriate review and agreement by the decisionmaking authority prior to commitment
of resources. The plan shall additionally describe criteria for acceptable risk.
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(and 4)
b. Hazard Identification. The specific safety hazard or list of hazards to be addressed by the safety
risk management plan shall be explicitly identified to prevent ambiguity in subsequent analysis and
assessment.
c. Analysis. Both elements of risk (hazard severity and likelihood of occurrence) shall be
characterized. The inability to quantify and/or lack of historical data on a particular hazard does not
exclude the hazard from this requirement. If the seriousness of a hazard can be expected to increase over
the effective life of the decision, this should be noted. Additionally, both elements should be estimated for
each hazard being analyzed, even if historical and/or quantitative data is not available.
d. Assessment. The combined impact of the risk elements in paragraph 5c shall be compared to
acceptability criteria and the results provided for decisionmaking.
e. Decision. The risk management decision shall consider the risk assessment results conducted in
accordance with paragraph 5d. Risk assessment results may be used to compare and contrast alternative
options.
6. PRINCIPLES FOR SAFETY RISK ASSESSMENT AND RISK CHARACTERIZATION. In
characterizing risk, one must comply with each of the following:
a. General. Safety risk assessments, to the maximum extent feasible:
(1) Are scientifically objective.
(2) Are unbiased.
(3) Include all relevant data available.
(4) Employ default or conservative assumptions only if situation-specific information is
not reasonably available. The basis of these assumptions must be clearly identified.
(5) Distinguish clearly as to what risks would be affected by the decision and what risks
would not.
(6) Are reasonably detailed and accurate.
(7) Relate to current risk or the risk resulting from not adopting the proposal being
considered.
(8) Allow for unknown and/or unquantifiable risks.
b. Principles. The principles to be applied when preparing safety risk assessments are:
(1) Each risk assessment should first analyze the two elements of risk: severity of the
hazard and likelihood of occurrence. Risk assessment is then performed by comparing the combined effect
of their characteristics to acceptable criteria as determined in the plan (paragraph 5a).
(2) A risk assessment may be qualitative and/or quantitative. To the maximum extent
practicable, these risk assessments will be quantitative.
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(3) The selection of a risk assessment methodology should be flexible.
(4) Basic assumptions should be documented or, if only bounds can be estimated reliably,
the range encompassed should be described.
(5) Significant risk assessment assumptions, inferences, or models should:
(a) Describe any model used in the risk assessment and make explicit the
assumptions incorporated in the model.
(b) Identify any policy or value judgments.
(c) Explain the basis for choices.
(d) Indicate the extent that the model and the assumptions incorporated have been
validated by or conflict with empirical data.
(6) All safety risk assessments should include or summarize the information of paragraphs
6a (3) and 6a(4) as well as 6b (4) and 6b (5). This record should be maintained by the organization
performing the assessment in accordance with Order 1350.15B, Records Organization, Transfer, and
Destruction Standards.
7. ANALYSIS OF RISK REDUCTION BENEFITS AND COSTS. For each high-consequence
decision, the following tasks shall be performed:
a. Compare the results of a risk assessment for each risk-reduction alternative considered,
including no action, in order to rank each risk assessment for decisionmaking purposes. The assessment
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System Safety Handbook系统安全手册下(108)
