Implementation Phase

Mitigation and Response Plan

Following identification and categorization, mitigation pathways (risk responses) will be discussed for each. The following are potential methods of mitigation:

ECN

The risk may be unacceptable and require a change to the design. The engineering change procedure will be used to document and track the change.

DFDS change

If the risk cannot be mitigated through design, it may be necessary to revisit the DURS (or URS) and get approval for a change to the specification.

Warning and training

If the risk cannot be mitigated and the URS cannot be changed, it may be necessary to live with the risk, but conduct additional tests and/or provide proper warnings on the instrument, in the manuals, and during training sessions to ensure operators are aware and take appropriate steps to avoid occurrences.

Diagnostics

It may be possible to provide diagnostics, either manually or automatically, that alert personnel to a potential failure mode (risk).

Service and support plan (maintenance)

In some cases, the only way to mitigate risk will be to plan for it. It is Expo's intention to establish enough design modularity that system uptime is maximized through the expedient of exchanging components that fail. The offending component can then be analyzed at the factory for its failure mode and the component design or processes can be improved in future products.

Process

A risk may be due to a suboptimal process, or personnel not following procedure. In this case, processes will be reviewed for effectiveness, including the adequacy of test procedures, and potential modifications to the risk assessment process itself.

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