Implementation Phase

Risk Assessment Protocol

Risks will be identified and assessed based upon established engineering principles, the collective experience of the development team, and extensive testing by Expo personnel and independent test houses. They will be categorized by:

Probability

How likely is the problem to occur? When determining probability, there are generally three categories to consider:

• Known risks with predictable outcomes.
• Known risks with unpredictable outcomes.
• Unknown risks with unpredictable outcomes.

Severity

If it occurs, what is the failure mode and how critical is it to the continued operation of the instrument and integrity of the measurement. Often, this analysis revolves around 'what if' questions.

Detectability

If it occurs, will it become obvious to the operator or other personnel, and when. Risk 'triggers' are a useful construct to use when determining if certain occurrences or activities are available to warn of impending risk.

Specificity

Once a problem is detected, can the offending component or cause be individually identified.

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