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Timely application of the O&SHA will provide design guidance. The findings and recommendations
resulting from the O&SHA may affect the diverse functional responsibilities associated with a given
program. Therefore, it is important that the analysis results are properly distributed for the effective
accomplishment of the O&SHA objectives. The techniques used to perform this analysis must be
carefully selected to minimize problems in integrating O&SHAs with other hazard analyses. The
O&SHA may be documented any format that provides clear and concise information to the non-safety
community.
A contractor may perform and document an O&SHA to examine procedurally controlled activities. The
O&SHA identifies and evaluates hazards resulting from the implementation of operations or tasks
performed by persons considering the following:
·  Planned system configuration/state at each phase of activity
·  Facility interfaces
·  Planned environments (or ranges thereof)
·  Supporting tools or other equipment, including software-controlled automatic test equipment,
specified for use
·  Operational/task sequence, concurrent task effects and limitations
·  Biotechnological factors, regulatory or contractually specified personnel safety and health
requirements
·  Potential for unplanned events, including hazards introduced by human errors.
The O&SHA must identify the safety requirements or alternatives needed to eliminate identified hazards,
or to reduce the associated risk to a level that is acceptable under either regulatory or contractually
specified criteria. The analysis may identify the following:
·  Activities that occur under hazardous conditions, their time periods, and the actions required
to minimize risk during these activities/time periods
·  Changes needed in functional or design requirements for system hardware/software, facilities,
tooling, or support/test equipment to eliminate hazards or reduce associated risks
·  Requirements for safety devices and equipment, including personnel safety and life support
equipment
·  Warnings, cautions, and special emergency procedures (e.g., egress, rescue, escape),
including those necessitated by failure of a software-controlled operation to produce the
expected and required safe result or indication
·  Requirements for handling, storage, transportation, maintenance, and disposal of hazardous
materials
·  Requirements for safety training and personnel certification.
FAA System Safety Handbook, Chapter 8: Safety Analysis/Hazard Analysis Tasks
December 30, 2000
8- 19
The O&SHA documents system safety assessment of procedures involved in system production,
deployment, installation, assembly, test, operation, maintenance, servicing, transportation, storage,
modification, and disposal. A contractor must update the O&SHA when needed as a result of any system
design or operational changes. If no specific analysis techniques are directed, the contractor should
obtain MA approval of technique(s) to be used prior to performing the analysis.
For work performed under contract, details to be specified in the SOW shall include, as applicable:
·  Minimum risk probability and severity reporting thresholds
·  Specification of desired analysis technique(s) and/or format
·  The specific procedures to be evaluated.
8.4.7 Activity 7: Health Hazard Assessment
The purpose of Activity 7 is to perform and document a Health Hazard Assessment (HHA) to identify
health hazards, evaluate proposed hazardous materials, and propose protective measures to reduce the
associated risk to a level acceptable to the MA.
The first step of the HHA is to identify and determine quantities of potentially hazardous materials or
physical agents (noise, radiation, heat stress, cold stress) involved with the system and its logistical
support. The next step is to analyze how these materials or physical agents are used in the system and for
its logistical support. Based on the use, quantity, and type of substance/agent, estimate where and how
personnel exposures may occur and if possible the degree or frequency of exposure. The final step
includes incorporation into the design of the system and its logistical support equipment/facilities,
cost-effective controls to reduce exposures to acceptable levels. The life-cycle costs of required controls
could be high, and consideration of alternative systems may be appropriate.
An HHA evaluates the hazards and costs due to system component materials, evaluates alternative
　
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